key: cord-317668-cc5oyiwp authors: wieland, mark l.; doubeni, chyke a.; sia, irene g. title: mayo clinic strategies for covid-19 community engagement with vulnerable populations date: 2020-06-22 journal: mayo clin proc doi: 10.1016/j.mayocp.2020.05.041 sha: doc_id: 317668 cord_uid: cc5oyiwp nan the coronavirus disease 2019 (covid-19) pandemic has impacted vulnerable populations disproportionately, including those affected by socioeconomic disadvantage, racial discrimination, low health literacy, immigration status, and limited english proficiency. african americans, hispanics, and native americans are dying at considerably higher rates across the country than whites. 1 these differences mirror existing disparities in other preventable health conditions and stem from risks that are rooted in the social determinants of health. socioeconomic disadvantage with disparate living and working conditions has likely increased the risk of acquisition and spread of covid-19 in vulnerable communities. preexisting disparities in chronic diseases that are associated with worse covid-19 outcomes and less access to health care have resulted in a higher case-fatality rate. current evidence and our experience suggest that community engagement may be a strategy for addressing the disproportionate prevalence and mortality of covid-19 in minority communities, which are manifestations of long-standing structural and societal inequities. community engagement, "the process of working collaboratively with and through groups of people… to address issues affecting the well-being of those people," 2 can help empower communities in promoting covid-19 prevention and containment. in community-engaged research (cenr) partnerships, community members and researchers collaborate through all phases of research. these partnerships are thus uniquely poised to assess and respond to the pandemic with community partners. they have the organizational and technical experience to reach vulnerable community members and address unmet needs. authentic cenr partnerships foster credibility with vulnerable communities through existing trusting relationships, which is needed for real-time collaboration during crises. herein, we describe some of the cenr approaches used at mayo clinic in response to the needs of medically underserved and socioeconomically disadvantaged communities. the approaches are undergirded by principles of community engagement as well as frameworks for socioeconomic issues and social determinants of health. critical to the design of effective cenr interventions are bidirectional communication, colearning, and understanding of unmet needs and existing assets. 3 mayo clinic cenr partnerships have observed several factors that negatively affected local communities. while credible covid-19 information had been translated into many languages and was widely available, that information was not reaching immigrant communities. the problem was exacerbated in some communities by a legacy of mistrust of health care institutions. community partners observed disruption of health care for populations with preexisting systemic barriers to using telehealth during the rapid shift to virtual-visit platforms. we then learned that these populations lacked access to testing and rapid results, which would reduce virus transmission, and that people and organizations in some minority communities, including faith-based organizations and health centers, were unprepared for the effects the virus would have in their communities. these barriers were compounded by unstable working conditions that often resulted in unsafe situations for vulnerable populations who comprise a disproportionate share of essential workers in some sectors or in layoffs, making access to health care even more complicated. neighborhoods with higher housing density, more housing insecurity, and more multigenerational households made social distancing difficult. additionally, multiple partners across mayo clinic catchment areas access to testing for their patients. for the african-american community, an adaptation of the cerc model evolved into a virtual town hall, which was hosted by a cross-sector team of clinicians, researchers, policy leaders, and community leaders. several lessons are emerging from this work. cenr is important but not sufficient. we continue to learn about social consequences of the crisis and know that a rapid, coordinated, and sustained response is needed across sectors and disciplines that places community voice at its center. for example, community health center partners needed telehealth infrastructure support to provide ongoing care, but this was not feasible within the cenr framework. we have also learned that a virtual environment needs to evolve to maintain ongoing engagement with community members, even though making the change may be disruptive at first. early in the crisis, we paused many community engagement activities because of the need for social distancing and the disruption of institutional operations. the disparities that emerged suggested that community engagement activities should have been accelerated instead. an opportunity was also missed to shorten response time by having the partnerships do more to promote greater general awareness of the potential for pandemic and the need for preparedness. thus, a multidisciplinary team is essential, given the scale of the pandemic and the pervasive health and social consequences. clear communication with institutional leaders is also important to ensure that they understand needs of the underserved, even as they grapple with fiscal and operational challenges in their institutions. the social and structural determinants of health have been understood for decades, and such determinants are also relevant to the disparities in health care that are exacerbated by the current covid-19 crisis. the focus of multisector collaboration and community engagement should be to inform programs and policies that will eliminate the disproportionate impact of pandemics on vulnerable communities. indispensable to such initiatives are collaborative, community-led solutions in removing structural barriers to health equity that currently exist. the covid tracking project. the covid racial data tracker community engagement key function committee, task force on the principles of community engagement processes, and outcomes: a health equity-focused scoping meta-review of community-engaged scholarship leveraging community engaged research partnerships for crisis and emergency risk communication to vulnerable populations in the covid-19 pandemic enfermedad del covid-19 preventing cardiovascular disease: participant perspectives of the faith! program office of health disparities research. native american research outreach editing, proofreading, and reference verification were provided by scientific publications, mayo clinic. key: cord-353482-dz343h7t authors: ellis, matthew; pant, puspa raj title: global community child health date: 2020-05-11 journal: int j environ res public health doi: 10.3390/ijerph17093331 sha: doc_id: 353482 cord_uid: dz343h7t this special issue of ijerph has published a range of studies in this developing field of global community child health research. a number of manuscripts submitted in response to our invitation describing ‘community-based interventions which impact on child health and wellbeing around the globe. in addition to rural community-based initiatives given that most children now live in cities we are also interested to hear about urban initiatives….’ we hope this issue will of great interest to the researchers and practitioners as well as academia from the fields of global health as well as global child health because it comprised of 14 articles representing all five continents. physical activity appears a key component of the scientific community’s current conception of child well-being judging from the four papers published addressing this area. this issue also has papers on childhood obesity to rubella vaccination. despite of the journal’s strive for reaching out to a wider global child health community, this issue missed contributions relating to child safeguarding and social determinants of urban health. global community child health focusses on the health and development of children in a community context across the globe. whilst some threats to the well-being of children may be globally determined (e.g., climate change) many others are more local (e.g., a busy trunk road). whatever the level of the threat it is the mobilisation of community and household level interventions to protect and enable children which lies at the heart of global community child health [1] . community health workers facilitate these interventions working with parents and carers [2] whilst schools, children's centres, nurseries and creches provide enabling environments for interventions to reach children directly. although we know that investment in early child development remains a top priority for all communities [3] , it is becoming clearer that exclusive attention to the early years misses important opportunities both in middle childhood and the adolescent period [4] . this edition of ijerph was conceived of as an opportunity to sample a range of studies in this developing field of research. we invited studies describing community-based interventions which impact on child health and wellbeing around the globe. in addition to rural community-based initiatives, given that most children now live in cities we are also interested to hear about urban initiatives. although sustainable development goal (sdg) three was our primary focus, we were keen to hear about multi-sectoral interventions with synergistic impact across the sdgs. the 14 accepted articles are global in their reach, with papers from all five inhabited continents. physical activity appears to be a key component of the scientific community's current conception of child well-being judging from the four papers published addressing this area [5] [6] [7] [8] . of course, given the global obesity epidemic, this will remain an important issue for community child health, though given the obesogenic environment we all face following societal nutrition transition we suspect the answers to this lie further upstream in the food industry's regulatory framework [9] . infectious disease, despite the epidemiological transition, remains a major threat in childhood everywhere and several aspects come up in this special issue-not least the awareness of a disease (rubella) amongst health care workers in tanzania for which there is an available vaccine [10] . this reminds us that for vaccination, its understanding and promotion are key tasks for community health workers around the globe, even more so in this age of vaccine hesitancy. if there may be one benevolent side effect of covid-19 going forward it may be the greater appreciation of the value of vaccines! we also publish a paper presenting evidence in support of a role for a bacterial lysate to stimulate immunity in childhood [11] and an interesting exploration of traditional healers' knowledge of noma [12] , the disfiguring facial erosion encountered in children in africa, which almost certainly relates to the continuing wide spectrum of infectious disease in childhood. this paper reminds us that community health workers take many forms and a functional health system finds ways of connecting all members of the health care community. community mobilisation through groups is an important vehicle for community child health initiatives and where some of the best evidence of impact lies [13] . in this edition fathers' roles in parent groups supporting families affected by zika virus [14] links well with our review of early intervention for infants at high risk of developmental disability [15] . a team working in fiji also make use of group-based interventions in their description of what a community child health initiative looks like in an island community [16] . the social determinants of health are central to the concept of community child health [17] . these determinants operate at household, local population ("community"), national and supranational levels. we were sorry not to see any contributions relating to child safeguarding-always a sensitive and difficult research area-but one which therefore needs to be illuminated by an especially powerful light! this would be especially timely as we move globally towards legislation outlawing the corporal punishment of children (https://endcorporalpunishment.org/countdown). of course, the physical environment in which children play, go to school and all too often work also has a major impact on their health. given that environmental health is a primary concern of this journal it was good to be able to accept two papers focussing on children, the first investigating the role of toys in the transmission of diarrhoeal disease at children's centres in south africa [18] and the second an exploratory study assessing pesticide levels in children's urine in mexico [19] . strikingly, we did not receive a community-based study from an urban slum where far too many of the world's children are growing up. if we are to promote "health for all" at all ages then we must ensure that, as "a future for the world's children" [20] puts it, "children grow up in safe and healthy environments, with clean water and air and safe spaces to play". research assessing the impact of community led initiatives into road traffic injury reduction, child safeguarding and the social determinants of health in urban slums should be a focus of community child health researchers going forward. community participation: lessons for maternal, newborn, and child health integrated management of childhood illness global survey report; world health organisation early child development-a winning combination disease control priorities, c.; adolescent, h.; development authors, g. investment in child and adolescent health and development: key messages from disease control priorities international comparison of the levels and potential correlates of objectively measured sedentary time and physical activity among three-to-four-year-old children physical activity and quality of life of healthy children and patients with hematological cancers effect of a multidimensional physical activity intervention on body mass index, skinfolds and fitness in south african children: results from a cluster-randomised controlled trial goal-framing and temporal-framing: effects on the acceptance of childhood simple obesity prevention messages among preschool children's caregivers in china beyond food promotion: a systematic review on the influence of the food industry on obesity-related dietary behaviour among children stray-pedersen, a. awareness and factors associated with health care worker's knowledge on rubella infection: a study after the introduction of rubella vaccine in tanzania impact of om-85 given during two consecutive years to children with a history of recurrent respiratory tract infections: a retrospective study sociodemographic characteristics of traditional healers and their knowledge of noma: a descriptive survey in three regions of mali women's groups practising participatory learning and action to improve maternal and newborn health in low-resource settings: a systematic review and meta-analysis engagement of fathers in parent group interventions for children with congenital zika syndrome: a qualitative study early intervention for children at high risk of developmental disability in low-and middle-income countries: a narrative review tuibeqa, i. strengthening health systems to support children with neurodevelopmental disabilities in fiji-a commentary commission on social determinants of, h. achieving health equity: from root causes to fair outcomes bacterial contamination of children's toys in rural day care centres and households in south africa urinary pesticide levels in children and adolescents residing in two agricultural communities in mexico a future for the world's children? a who-unicef-lancet commission key: cord-289041-lhc53uk4 authors: nadeem, muhammad faisal; samanta, soumya; mustafa, fatima title: is the paradigm of community pharmacy practice expected to shift due to covid-19? date: 2020-05-27 journal: res social adm pharm doi: 10.1016/j.sapharm.2020.05.021 sha: doc_id: 289041 cord_uid: lhc53uk4 nan humanity has always been challenged by the agony associated with pandemics. from bubonic plague (1347-1351) to the spanish flu (1918) (1919) , the world has suffered a great deal in terms of humanistic and monetary loss [1] . likewise, covid-19 has ravaged the whole world and posed new challenges for the healthcare systems of both developed and developing nations [2] . in particular, due to a number of lapses in healthcare systems, developing nations have had difficulty adopting the recommended response strategy − including early detection, prompt isolation and initiation of effective infection prevention and control (ipc) measures; delivery of symptomatic care for those with mild illness; and optimized supportive care for those with severe, and public health quarantine − to flatten the contagion curve. amidst the abysmally high upsurge of covid-19 cases worldwide when local, state, and national government and healthcare agencies are searching for strategies to wage the war against pandemic, community pharmacy practice has been gaining momentum and undergoing major paradigm shifts [3] . recognizing the need for fully fledged community pharmacy services, regulatory authorities in many developed countries, such as china, the united kingdom (uk), the united states (us), australia. and canada have waived multiple legislations and published additional guidance for community pharmacies [4] [5] [6] [7] [8] . this discussion aims to give overview of the emerging services and flexibilities in pharmaceutical regulations that could shift the paradigm of community pharmacy practice and help community pharmacists move from the bleeding edge to the cutting edge ( figure 1 ). moreover, this letter is expected to pique the attention of pharmaceutical regulatory bodies in developing nations towards the potential of community pharmacy services to knock down challenges concerning covid-19 havoc. pharmacists should be authorized "to order, collect specimens, conduct and interpret tests and, when appropriate, initiate treatment for infectious diseases including covid-19" [9] . realizing the need to expand the availability of rapid testing and reduce unnecessary travel to remote testing sites, the u.s. department of health & human services (hhs) has permitted pharmacists to conduct covid-19 tests [8] . in conjunction, they are authorized to perform antibody testing which will assist to conclude whether a patient has already healed from the infection, and have immunity to continue [8] . given the recent test authorization, the fda is expected to approve the forthcoming covid-19 vaccine to be administered by pharmacist as the benefits of authorizing community pharmacists to assist with vaccination and immunization have been established since the previous influenza pandemic in 2013 [9] . authorizing such roles (i.e., test-treat-immunize) will unleash the full potential of community pharmacists and thus appears more likely to accelerate the paradigm shift from dispensing and indirect clinical focus to more direct clinical and patient centered healthcare relationships with patients/customers as well as other healthcare professionals. other major paradigm shift in community pharmacy services would be attributable to telepharmacy and home delivery of services. the idea of pharmacists being able to render essential public health contributions via telepharmacy and home delivery is built on irrefutable logic. when hospitals are buckled beneath the weight of covid-19 cases and the world is striving to adhere to the self-isolation and social-distancing rules, telepharmacy and home delivery of medicines are of great significance not only for covid-19 confirmed or suspected patient, but also for the patients with communicable and non-communicable diseases, and most vulnerable members of the community (i.e, elderly, pregnant women and children). the benefits of these services are represented by a wide range of the pharmaceutical service, including drug review and monitoring, sterile and non-sterile compounding verification, medication therapy management (mtm), patient assessment, clinical consultation, outcomes assessment, decision support, and drug information from medication selection [10, 11] . in the past, these services has been utilized by communities throughout the us, spain, denmark, egypt, france, canada, italy, scotland, and germany to improve access to pharmacy services, especially in underserved populations [12] . likewise, many countries, such as australia, the united states, and the united kingdom have now adopted these services in response to covid-19 pandemic. however, despite dire need of telepharmacy and home delivery of medicines in covid-19 prevalent developing nations, many factors, such as community pharmacist willingness, limited workforce, lack of expertise, financial reimbursement, infrastructure of community pharmacies may be to blame for low uptake of these services. regardless of all the barricades, the shift in the community pharmacy paradigm -in terms of identity and recognition as a competent and trustworthy healthcare professionals -is expected to happen through telepharmacy and home delivery of services and medicines due to increased chances for direct interaction with patients in need of these services, only if community pharmacists aim to avail the opportunities rather than moaning about existing issues. they ought to embrace the notion "more the interaction you make, more opportunity you have to make positive impact on others (patients)" in light of covid-19 driven medication disruptions and limited access to essential medicines, a number of flexibilities in pharmaceutical regulations have been observed in many nations, which are anticipated to foster the role of community pharmacists [4] [5] [6] [7] [8] . pharmacists have been authorized to conduct therapeutic interchange and substitution without physician authorization when product shortages arise to ensure continuity of therapy during shortage of the prescribed medicine. in some countries or territories, pharmacists have been authorized to repeat dispensing of prescribed medicines for patients with long-term conditions in-order to improve patient adherence to medicine therapy and minimize the need for medical appointments. in the same manner, the fda has temporary authorized compounding pharmacies to compound fdaapproved drugs to address the shortage of certain crucial drugs (i.e., sedatives, anesthetics, painkillers, and muscle relaxants etc) used in the treatment of covid-19 [8] . furthermore, considering the needs of patients requiring controlled drugs, -including opioid medicines for palliative care, severe pain management, or taking regular opioid substitution therapy -, pharmacists are temporarily permitted to extend prescriptions, pass prescriptions to other pharmacists, and allow pharmacy employees to deliver prescriptions of controlled substances to patients' homes. though these flexibilities in legislations are temporary due to a number of medication safety concerns and irrational practices, at least pharmacists now have the opportunity to take complete accountability for a patient's medication. pharmacy related organization in other nations must urge these legislations to support patients and prescribers during the covid-19 response, and enable satisfactory integration of the prescription and supply of medicines. however in developing nations, ensuring the availability of trained pharmacist at community settings and required equipments will be critical components of any initiative to leeway the pharmaceutical legislations. to sum up, the health governments across the globe are loosening pharmaceutical legislations and expanding community pharmacy services in response to covid-19 havoc with the clear objective of improving access to requisite healthcare services and medicines. however this may not be easy to follow for developing nations, as community pharmacy services in these settings are thwarted by societal, technical and economic barriers. but, as we see it, healthcare regulators in developing nations, where ensuring access to healthcare services and essential medicines has always been a great challenge, will need to utilize and promote community pharmacy services to cater the needs of vulnerable population during the covid-19 pandemic. in doing so, community pharmacists across the globe will assume new responsibilities, assist patients attain healthy outcomes and provide value previously unrecognized by the healthcare professionals, population and healthcare system. nevertheless, in this regard, national pharmacy organizations need to play a key role with clearer and more direct approaches to articulate their suggestions in-order to shift community pharmacy practice from the bleeding edge to the cutting edge. they should ferret out additional indicators of paradigm shifts and request to be included at the table when previous rules are revised or new healthcare policies are being devised. new development:'healing at a distance'-telemedicine and covid-19 how will country-based mitigation measures influence the course of the covid-19 epidemic? the lancet on the frontline against covid-19: community pharmacists' contribution during a public health crisis recommendations and guidance for providing pharmaceutical care services during covid-19 pandemic: a china perspective summary of covid-19 regulatory changes from regulatory flexibility to reimbursement changes, how canadian regulators and payers are managing the covid-19 crisis update on new legislation relating to controlled drugs during the covid-19 pandemic pharmacy developments related to covid-19 testing and compounding of critical drugs executive summary: pharmacists as front-line responders for covid-19 patient care 2020 a systematic review of icu and non-icu clinical pharmacy services using telepharmacy telepharmacy services: present status and future perspectives: a review we declare no competing interests. key: cord-027798-aq13cugo authors: kenny, sue title: covid-19 and community development date: 2020-06-01 journal: community dev j doi: 10.1093/cdj/bsaa020 sha: doc_id: 27798 cord_uid: aq13cugo nan joining balcony singing groups, have all helped to maintain social connections, and in so doing, boost community solidarity. after four decades which have been dominated by the neo-liberal values of competition and individual self-reliance, the validation of community co-operation and collaboration is to be welcomed. we cannot ignore the immense suffering that has resulted from covid-19, which is experienced unequally within and between societies. for example, contagion spreads more effectively in overcrowded poor areas, and these are often the areas with the most limited health facilities. in this context not-for-profit community organisations have stepped in as central players in welfare delivery. while welfare provision has always been the remit of many community organisations, their pivotal role is increasingly recognised, as state welfare programs and the privatised for-profit welfare delivery system are unable to keep up with demand. community organisations are now responding to the needs of those who are newly unemployed, sick and homeless and the increasing need for intervention in situations of family violence. in the context of the immense demand, there is growing pressure for community development practitioners to focus entirely on welfare work, as agents of the "benign" state. if we nudge our attention away from the normatively driven conception of community, other ways in which communities are stepping in to protect against covid-19 raise some serious concerns. first, fear and panic have resulted in the closure of ranks amongst "insiders" and the othering of those who are deemed to pose a threat in so far as they might be carrying the virus. fear of the stranger is now back in force as refugees, people who are homeless and those coming from outside a neighbourhood or town are made to feel unwelcome. second, once governments introduce policies such as social distancing and social isolation to stem the spread of the covid-19 pandemic, they are faced with the task of ensuring that citizens are compliant. there are several ways in which they do this. they harness the powers of the police. they use existing tracing mechanisms such as apps, or what bartos (2020) calls "the panoptican in your pocket". but possibly the most effective way of checking on citizens' conformity is when fearful communities monitor themselves to ensure compliance with the new laws and regulations. by reporting transgressions, communities become part of the repressive state. in this context the solidarity of community is contingent upon obedience to the state. as individuals take on the role of self-righteous monitoring, communities become the agents of self-surveillance. these last activities are problematic elements of the community response to covid-19. yet there is another issue facing community development practitioners as they grapple with the effects of the pandemic. this is the largely apolitical nature of the response. providing welfare and supporting initiatives to sustain social connectedness should not mean withdrawing from our political and politicising activities. indeed, it might well be that as the economic system driven by neo-liberal theory withers and the importance of collective endeavour is recognised, we have the best opportunity in a long while to be able to reshape thinking, structures and practices. however the opportunities to demand a more collaborative, democratic and just society are being threatened by a political form that is already casting a shadow over the responses to covid-19. this political form is authoritarianism. a society in which fear is amplified, power is ceded to governments and communities practise self-surveillance provides an ideal setting for authoritarian practices. even before covid-19, many parts of the world had been in the grip of, or on the edge of authoritarianism. take for example, the countries that have been dominated by populist politics. a central feature of populist politics is the view that it is the prerogative of populist leaders, operating on behalf of the people (or as hugo chavez famously remarked, operating "as the people") to identify and respond to dangers. as people look for reassurances from politicians and more decision-making is handed over to political leaders, as is happening during the covid-19 pandemic, a precedent is established, which gives leaders extra leeway to take control and to present themselves as saviours. once populist leaders gain uncontested power, they can weaken or dismantle the institutions of democracy such as the judiciary and a free press, and strengthen methods of surveillance. in addition, the fear of outsiders bringing in the virus has meant the closure of borders, while also firing up nationalism and nurturing xenophobia, all of which are effective devices in the hands of authoritarian populists. nevertheless, there is a growing chorus of voices warning us of the ways in which authoritarianism is seeping into the fabric of society, particularly when this takes place under the guise of controlling the covid-19 pandemic. for example, we are being alerted to the ways in which authoritarian populists such as orban in hungary and bolsonaro in brazil have used the pandemic as a cover to extend their powers, by eliminating dissent and extending state surveillance. as the quasi-populist uk government responds to the pandemic, transparency is diminishing, as demonstrated by government redaction of important advice from health scientists (lewis and conn 2020) . what is also being reported is that the extension of the powers of populist leaders does not seem to have increased their popularity, and despite their claims to be able to "uniquely speak for the people" and "resolve their issues", right-wing populist governments have been unable to curtail the spread of covid-19, particularly in italy, the usa and brazil. but whether this affects a longer term trajectory towards populist authoritarianism remains to be seen. at the beginning of may, 2020, what can those committed to community development be doing in response to the covid-19 pandemic and the changing socio-political milieu? should we be waiting for a clearer picture of how politics and economics are playing out or should we be responding to the situation as we find it, and if so how? do we put our energies into organising at the local, national or global level? while constant monitoring of socio-political shifts and the progress of various responses to the virus, it would seem to me that there are five political actions that we can take now. these are first, to join the chorus of those alerting the world to the threats and dangers of authoritarianism. authoritarian regimes straight-jacket civil society, and thus community development as well. there is a caveat here however. warning about authoritarianism does not mean validating the views of radical libertarians who reject all state interventions. second, we can work with our networks to expose the ways in which the catastrophic loss of livelihoods, spread unevenly within and between societies, is not just the outcome of the covid-19 pandemic, but results from how societies are organised-around exploitation, inequality and pervasive neo-liberal ideology. third, linking with our networks, we can agitate to ensure that knowledge, expertise and resources concerning covid-19 are shared across the world, rather than being used as devices for gaining power and money. fourth, the corollary of the massive failures of contemporary societies is that we need to be mobilising for a radical reconfiguration of society. there is no "return to normal". of course, like the suggestions above, those committed to community development cannot do this alone. it requires determined political activism, globally, nationally and locally. finally though, an advantage of being involved in community development is that we can point to the thousands of small scale initiatives that pre-figure very different ways of organising society. from these sources we could develop a kit-bag of exemplars that demonstrate the value of how to organise using such principles as social and ecological justice, collaboration and deliberative democracy. these actions are all the more urgent because what happens in response to the 2020 covid-19 pandemic is a rehearsal for the even bigger challenge for a humanity losing its way, climate change. panopticon in your pocket covid-19 and community development 5 uk scientists condemn 'stalinist' attempt to censor covid-19 advice, the guardian key: cord-354987-e2d5w6w3 authors: aguado, brian a.; porras, ana m. title: building a virtual community to support and celebrate the success of latinx scientists date: 2020-10-20 journal: nat rev mater doi: 10.1038/s41578-020-00259-8 sha: doc_id: 354987 cord_uid: e2d5w6w3 in february 2019, we co-founded latinxinbme to build a diverse and welcoming virtual community of latinx researchers in biomedical engineering (bme). we leverage digital tools and community mentoring approaches to support our members and to build safe spaces in academia, with the aim to diversify the academic workforce in stem. future pi slack. slack has the advantage to create channels centred around specific topics, centralize information relevant to the community, initiate private messages between members and engage latinx bmes across time zones and locations. the most active channels in our slack community fit into a few categories: careers (for example, #industry-jobs, #academic-jobs), mentoring (for example, #undergrad-to-grad), mental health (for example, #highsandlows) and issues that impact latinx communities (for example, #immigration-woes). the channel conversations ensure that members receive the mentorship they need to be successful in their next career steps. since our founding, we have recruited 175 members on slack (fig. 1b) . latinxinbme members include 12 different latin american nationalities and a variety of bme sub-disciplines, including biomechanics, biomaterials, tissue engineering, regenerative medicine, imaging, neural engineering, drug delivery and microfluidics. our recruitment strategy first relied on reaching out to our immediate latinx friends and colleagues. to maintain growth, we consistently promote our group at conferences and seminars, rely on non-latinx allies to spread the word, and reach out to prospective members. new members first enter our slack space through the #introductions channel, where they are welcomed by the community and where they can begin to interact with others with similar interests. out of 57 surveyed members, 9% are undergraduate students, 56% are graduate students, 17% are postdoctoral fellows, 11% are assistant professors, 5% are associate or full professors with tenure and 2% are members with industry careers (fig. 1c) . twitter. our community is active on twitter (@latinxinbme), where we highlight our members and their professional successes, advertise job openings, internship opportunities and professional development workshops, and share resources to support diversity, equity and inclusion. for example, we leverage national events, such as the hispanic/latinx heritage month building a virtual community to support and celebrate the success of latinx scientists in february 2019, we co-founded latinxinbme to build a diverse and welcoming virtual community of latinx researchers in biomedical engineering (bme). we leverage digital tools and community mentoring approaches to support our members and to build safe spaces in academia, with the aim to diversify the academic workforce in stem. www.nature.com/natrevmats (annually from september 15 to october 15), to highlight our current members and encourage new members to join. additionally, twitter allows us to interact with other organisations and leaders dedicated to expanding diversity in stem. for example, to promote multilingual science communication 6 , latinxinbme colla borates with the tissue engineering and regenerative medicine international society (termis), student and young investigator section (syis) to post weekly tweets that list english-to-spanish translations of vocabulary related to types of biomaterials, cell culture, materials chemistry and characterisation techniques. community-building and mentoring virtual events. the latinxinbme community is spread out across the world (albeit most members are in the usa) and thus, we rely on technology to keep the community connected. we host professional development events, including virtual writing groups, one-on-one meetings and q&a sessions discussing interviews for graduate school as well as regular social mixers. in-person events. the latinxinbme community hosts in-person networking events to complement our virtual programmes and to provide an opportunity to get to know each other as friends and colleagues through informal activities, such as dinners. these events often spontaneously turn into mentoring, brainstorming or listening sessions. latinxinbme members have organized networking events at the society for biomaterials (sfb) annual meeting, the biomedical engineering society (bmes) annual meeting, the gordon research conferences, the cell and molecular bioengineering conference, the american association for the advancement of science annual meeting, and the society for advancement of chicanos/hispanics and native americans in science diversity in stem conference. addressing latinx-specific issues. the slack platform provides spaces for reflection to analyse and discuss academic and societal issues specific to our latinx community through the lenses of our cultures, intersecting identities and lived experiences. for example, constant changes in us immigration policies negatively impact our members and have spurred virtual conversations in which to vent about the situation and develop action items, including contacting local representatives. after the murders of george floyd, breonna taylor, elijah mcclain and countless other black citizens at the hands of law enforcement, we discussed the #blacklivesmatter movement and how to support anti-racism practices, and how to best engage our latinx family, friends and colleagues in this cause. advocacy efforts. part of our mission is to advocate for the inclusion, support and well-being of all latinxinbme scholars at local and national levels. our members have participated in various efforts to advocate for diversity and inclusion in their departments and they engage with their local latinx communities. on a national level, we -the latinxinbme co-foundersserved on the sfb diversity task force to help establish the new society for biomaterials diversity, equity and inclusion committee. we are also hosting a virtual panel session at the bmes 2020 annual meeting with support from the biomedical engineering society diversity committee to highlight research conducted by latinx in bme and to provide a space for attendees to learn about experiences of marginalized early-career biomedical engineers. build your own community. the goals and strategies of latinxinbme transcend fields and disciplines. although our focus is to support the bme latinx community, we believe this framework can be used to create spaces for other communities that are historically excluded and underrepresented in stem. similar virtual communities, such as @latinxchem, @geolatinas and @blackinengineering, have also been successful at builing virtual spaces for marginalized groups in stem and in providing remote mentorship opportunities to trainees. allyship. we encourage our non-latinx colleagues to engage with us, learn from our experiences and understand the systemic barriers that drive the underrepresentation of latinx in bme. allies must recognize the pool of talent present within our community, recruit students, postdocs, staff and faculty, and create and fund programmes that foster the representation, growth and success of latinx and other marginalized groups in stem. faculty in influential positions must take an active role in diversifying undergraduate and graduate admissions (for example, by eliminating the use of standardi zed tests such as the graduate record examination 7 , by providing application fee waivers and by building meaningful relationships with hispanic-serving institutions, historically black colleges and universities, and tribal colleges and universities). faculty and deans must also commit to bold efforts when hiring faculty (for example, cluster hiring for tenure-track professors, expanding recruitment pools and reassessing of hiring criteria). however, recruiting alone will not fix the deep inequities that permeate stem and higher education. ensuring equal opportunity is crucial at the individual level (for example, inviting underrepresented colleagues to give talks, collaborating on grants and co-authoring manuscripts) and on an institutional level (for example, redefining graduation, hiring and promotion criteria to recognize diversity, equity and inclusion efforts, which are often ignored in performance evaluations). colleagues must also create welcoming and safe work environments and help stop racist behaviours that infect the stem community and leave the latinx community powerless. stop assuming that the latinx scientist down the hall is the janitor. stop joking that latinx scientists are good at making cocaine in the lab. stop mentioning that accents are distracting in presentations. stop thinking that latinx immigrants are stealing jobs. stop saying that we were awarded a fellowship because we are latinx. outcomes. although our organization is young, we are already seeing positive effects. we have mentored undergraduate students through two academic admissions cycles. several of our graduate student members have asked for feedback on fellowship applications and have been awarded national science foundation graduate research fellowships and other awards. in the faculty recruitment cycle for 2019/2020, three of our postdoctoral latinxinbme members, mentored by other members of the community, secured faculty positions, indicating that our efforts may help future postdoctoral fellows pursue an academic career. faculty have been able to share resources and invite each other to their department seminar series. our virtual community has also provided much needed support during the covid-19 pandemic. closing thoughts latinxinbme has filled a void in our field by connecting latinx biomedical engineers, countering feelings of institutional isolation and exclusion, and fostering inclusion in the broader scientific community. as showcased by our preliminary outcomes, our approaches could help increase the representation and success of latinx scho lars in academia. however, we will not achieve this goal without commitment and actions at higher levels of academic leadership. we will continue to counteract latinx stereotypes and increase awareness of the talent within our community. we are optimistic that our efforts may one day lead to a stem workforce that reflects the rich diversity of our global neighbourhoods and ensures that everyone who wants to practice science feels welcomed, included and valued. engineering by the numbers latino engineering faculty in the united states latino stem scholars, barriers, and mental health: a review of the literature national academies of sciences, e. & medicine. the science of effective mentorship in stemm science communication in multiple languages is critical to its effectiveness questioning the value of the graduate record examinations (gre) in phd admissions in biomedical engineering inclusion-committee tissue engineering and regenerative medicine society we abundantly thank all our latinxinbme members and allies, as this work would not be possible without your enthusiasm and engagement. b.a.a. acknowledges funding from the nih (k99 hl148542) and the burroughs wellcome fund postdoctoral enrichment program. a.m.p acknowledges funding from the cornell presidential fellows program. there is no competing interest. key: cord-271876-kln3t3ru authors: bloomfield, sally f.; cookson, barry; falkiner, fred; griffith, chris; cleary, vivien title: methicillin-resistant staphylococcus aureus, clostridium difficile, and extended-spectrum β-lactamase–producing escherichia coli in the community: assessing the problem and controlling the spread date: 2007-03-31 journal: american journal of infection control doi: 10.1016/j.ajic.2006.10.003 sha: doc_id: 271876 cord_uid: kln3t3ru although health care-associated methicillin resistant staphylococcus aureus and clostridium difficile strains are primarily a risk to hospital patients, people are increasingly concerned about their potential to circulate in the community and the home. they are thus looking for support in order to understand the extent of the risk, and guidance on how to deal with situations where preventing infection from these species becomes their responsibility. a further concern are the community-acquired mrsa and c. difficile strains, and other antibiotic resistant strains circulating in the community such as the extended-spectrum β-lactamase (esbl) escherichia coli. in response to concerns about such organisms in the community, the international scientific forum on home hygiene has produced a report evaluating mrsa, c. difficile, and esbl-producing e. coli from a community viewpoint. the report summarizes what is known about their prevalence in the community, their mode of transmission in the home, and the extent to which they represent a risk. it also includes “advice sheets” giving practical guidance on what to do when there is a risk of infection transmission in the home. methicillin-resistant staphylococcus aureus, clostridium difficile, and extended-spectrum b-lactamaseproducing escherichia coli in the community: assessing the problem and controlling the spread although health care-associated methicillin resistant staphylococcus aureus and clostridium difficile strains are primarily a risk to hospital patients, people are increasingly concerned about their potential to circulate in the community and the home. they are thus looking for support in order to understand the extent of the risk, and guidance on how to deal with situations where preventing infection from these species becomes their responsibility. a further concern are the community-acquired mrsa and c. difficile strains, and other antibiotic resistant strains circulating in the community such as the extended-spectrum b-lactamase (esbl) escherichia coli. in response to concerns about such organisms in the community, the international scientific forum on home hygiene has produced a report evaluating mrsa, c. difficile, and esbl-producing e. coli from a community viewpoint. the report summarizes what is known about their prevalence in the community, their mode of transmission in the home, and the extent to which they represent a risk. for bacterial strains, such as methicillin-resistant staphylococcus aureus (mrsa), clostridium difficile, and extended-spectrum b-lactamase (esbl)-producing escherichia coli, the use of antibiotics is a common factor that is related to their emergence and spread. although health care-associated mrsa (hca-mrsa) and c difficile strains are primarily a risk to vulnerable patients in hospitals, people are increasingly aware and concerned about the potential for these organisms to circulate between the hospital and other settings, including the home. thus, they are looking for support to understand the extent of the risk to themselves and their family, and guidance on how to deal with situations where preventing infection from these species may become their responsibility (eg, caring for someone at home who is infected or has increased vulnerability to infection, or visiting someone in the hospital who may be at risk from visitors who are colonized or infected). a further, and possibly greater, concern are the ''newer'' community-acquired mrsa (ca-mrsa) and c difficile strains that are now known to have emerged de novo in the community from community-based strains. in contrast with hca-mrsa, ca-mrsa strains are more virulent, and cause infections of cuts, wounds, and abrasions, which are more prevalent among children and young adults. one of the main reasons for concern is that these strains have acquired the ability to produce panton-valentine leukocidin (pvl) toxin, which can lead to serious and potentially fatal skin and soft tissue (sometimes necrotizing) infections. although the data are difficult to interpret, because they are mostly generated by reference laboratories, it is thought that a significant portion of pvl-producing strains circulating in the general community are also methicillin resistant. 1, 2 indications are that these pvl-producing ca-mrsa strains are easily transmissible not only within families, but also on a larger scale in community settings (eg, prisons, schools, sport teams) and among intravenous drug addicts; skin-to-skin contact (including unabraded skin) and indirect contact with contaminated shared objects (e.g., towels, sheets, sports equipment) seem to represent the main mode of transmission. this is particularly likely where there are shared contaminated items, poor hygiene, and crowded living conditions. a further concern is that these strains are now showing the propensity to not only spread rapidly in the community, but also into hospitals, thereby compromising efforts to control mrsa in these settings. 2, 3 for c difficile, concerns in the community relate to the emergence of a more virulent type (type nap1/ 027) that seems to have the ability to produce greater quantities of toxins, and, unlike many previous c difficile strains, is resistant to floroquinolone antibiotics. in the united states in 2005, several cases of c difficile-associated disease were reported in patients in whom there was minimal or no exposure to health care settings and no recent antibiotic use (ie, they were community acquired). 4 in response to concerns about such organisms in the community, the international scientific forum on home hygiene (ifh) produced a report that evaluated mrsa, c difficile, and esbl-producing e coli from a community viewpoint. 5 the report summarizes what is known about these organisms, their prevalence in the community, their likely mode of transmission in the home, and the extent to which they represent a risk. its purpose is to provide a source of information for health professionals, scientific writers, and others who communicate directly with the public on infectious disease and home hygiene. the appendices include ''advice sheets'' that give practical guidance on what to do when there is a risk for infection transmission in the home. in accordance with ifh policy, the evidence base for the practical information is reviewed. the report suggests that, for all 3 species, although home-dwellers who are infected or colonized with these organisms are reported frequently in the literature, the overall prevalence of infected individuals or colonized carriers in the community, at least in the uk, is still low. it is recognized, however, that geographical variations occur; this prevalence may be increasing in parts of the united states. 6 the evidence suggests that when these strains are introduced into the home by an infected individual or a carrier or via domestic animals, there is significant potential for spread by direct or indirect contact (eg, via the hands; hand, body, or food contact surfaces; cleaning cloths), such that other family members are exposed and may become colonized or infected. the prevalence and potential for spread of mrsa in the home environment is shown by a recent study at the center for hygiene and health at simmons college in boston, ma (elizabeth scott, bsc, phd, personal communication, 2006) . the ca-mrsa was isolated from 7 of 35 homes (20%) that were sampled in the boston area; it was found on a variety of household surfaces, including hand contact surfaces and cleaning utensils. the major concern in public health terms is that, as the proportion of people in the general population who carry these strains as part of their normal flora increases, there is an increasing probability that clinical infections, either in the community or in the hospital, may be attributable to one of these strains. although the ifh report highlights significant differences between these 3 strains, it also suggests common patterns. from this it is possible to formulate a strategy that could reduce the impact of these and other emergent strains. the key components of such a strategy include better monitoring of antibiotic utilization together with promotion of appropriate hygiene to prevent spread from infected or colonized family members, protect vulnerable groups from exposure, and reduce transmission among healthy family members. in situations where someone is known to be infected with or carrying a specific pathogen, or where family members need to be protected against a specific pathogen (eg, ca-mrsa), hygiene advice to the family can be based on assessment of the critical control points for preventing spread of the particular organism. in contrast, reducing the circulation of these organisms in the healthy community by reducing opportunities for spread of colonization among family members and domestic animals depends on persuading people to practice good hygiene on a routine basis. good day-to-day hygiene means adopting the ifh risk assessment or ''targeted'' approach to home hygiene as outlined in the ifh guidelines and recommendations on home hygiene, or in the ifh home hygiene training resource. [7] [8] [9] in situations where someone is more vulnerable to infection, for the most part this still means targeted hygiene. the major difference is that, if hygiene practices are not applied consistently and rigorously, the risk for infection is much greater. in reality, the problems that are posed by ''emergent pathogens'' are only one of the reasons why we need to persuade the public to share the responsibility for infection control and adopt better standards of day-to-day hygiene. other factors include the continuing high levels of infectious intestinal disease; the increasing elderly population and shorter hospital stays, which mean greater numbers of vulnerable people in the community; and the emergence of diseases, such as severe acute respiratory syndrome (sars) and avian flu. to achieve this, however, we need to abandon our fragmented approach to hygiene promotionwhereby food hygiene advice is given separately from advice on hand hygiene, care of the sick, or preventing the spread of flu or mrsa-and look at hygiene holistically from the point of view of the family and the range of problems that they face in protecting themselves from infection. the fact that advice on these aspects of hygiene is given separately means that the community does not have a comprehensive understanding about how infectious diseases are spread in the home; thus, hygiene practice largely is rule based. this makes it difficult for hygiene knowledge to be adapted to different risks (eg, those posed by pathogens with dissimilar properties and routes of transmission), or to the varying needs of different family members with various levels of vulnerability to infection. the threat that is posed by diseases such as avian influenza and sars demands an immediate response, which requires adequate and advance preparation. to achieve all this, greater emphasis on appropriate hygiene education in schools is needed. additionally, the public must be given clear, unambiguous information on the nature of the threat posed by infectious disease agents together with advice on how to target hygiene measures to minimize the risks of exposure to potentially harmful microbes. methicillin-resistant s. aureus infections among patients in the emergency department community-acquired mrsa: can we control it? the emergence of infections with community-associated methicillin resistant staphylococcus aureus severe clostridium difficile-associated disease in populations previously at low risk-four states clostridium difficile and esbl-producing escherichia coli in the home and communityassessing the problem, controlling the spread emergence of community-acquired methicillin-resistant staphylococcus aureus as the predominant cause of skin and soft tissue infections guidelines for prevention of infection and cross infection in the domestic environment recommendations for selection of suitable hygiene procedures for use in the domestic environment home hygiene-prevention of infection at home: a training resource for carers and their trainers key: cord-031995-itu5ix98 authors: goglio-primard, karine; simon, laurent; cohendet, patrick; aharonson, barak s.; wenger-trayner, etienne title: managing with communities for innovation, agility, and resilience date: 2020-09-17 journal: nan doi: 10.1016/j.emj.2020.08.003 sha: doc_id: 31995 cord_uid: itu5ix98 nan the covid-19 pandemic is a health and social crisis devastating populations and disrupting our society, economy, and organizations. in response, companies such as dassault aviation proposed leveraging collective intelligence to source, qualify, and design engineering and manufacturing solutions. an open covid-19 community emerged to consolidate a worldwide list of projects and connect them to people looking for solutions or willing to help. unprecedented collaborative impulses and communitarian gatherings developed in all areas: help for caregivers (carers), support for families, a consortium of companies to respond to the shortage of resuscitation equipment, etc. in these troubled times, the spontaneous responses from communities are multiple and impactful, supporting creative endeavors and fostering innovations for resilience. the concept of knowing communities (kcs) refers to the vast body of creative informal networks that repeatedly interact and exchange knowledge to support the dynamic processes of creation and innovation (amin & roberts, 2008; cohendet et al., 2008) . these informal groups are made up of individuals willing to produce and mutualize new knowledge by connecting people belonging to different entities (david & foray, 2002) . their properties emphasize their social dimension: the voluntary commitment to exchange and share common cognitive resources; a common identity built on their practice and repeated exchange; and the respect of specific social norms (cohendet et al., 2008; wenger, 1998) . knowing communities leverage value creation and performance within firms (brown & duguid, 1991 , 2001 lave & wenger, 1991; wenger et al., 2002 wenger et al., , 2011 wenger-trayner, fenton-o'creevy, hutchinson, & kubiak, 2015) and favor innovation. their role appears even more essential in times of crisis as they provide rapid answers to complex issues and foster collective resilience. the solutions lie in the attitudes of individuals and collectives and cannot be found only in controlled, predictive, streamlined, and optimized systems. the formation of a broad community of peers and experts from different disciplines frees the collective intelligence and social imagination. within this vast body of knowing communities, the notion of collective has been recently introduced and studied in the practice-based theory of knowledge. in 2009, laurent simon's (2009) study of creative cities identified a new and "unrecognized actor" referred to as "creative collective." for simon, this particular form of groups is neither a network (even though it is connected to networks), nor a pure form of community (even though it shares some of its characteristics). this hybrid form comes across as a "truly communitarian form of a community" (p. 41) whose members gather to defend a common vision presented as a creative alternative. rather than gathering for the main purpose of producing or accumulating knowledge, they mostly gather around shared values and for the defense of social progress. while these groups claim a specific identity (cohendet, 2006) , they also need knowledge and competences to serve their project (paraponaris & rohr, 2015) . collectives are defined as informal networks made up of heterogeneous actors promoting a common societal cause (crespin-mazet et al., 2017) and can be seen as precursors of epistemic communities. while communities emphasize the acquisition of expertise or free access to expertise located in other organizations (scientific goal), collectives emphasize altruism, public action, the adoption of innovative practices by the largest number, and the highest level of sharing among members in order to transform society. in sum, members of communities cooperate to increase their skills and practice while members of collectives collaborate because they share specific values reflecting the dynamics of civil society (paraponaris & rohr, 2015) . the complementary roles of communities and collectives in times of crisis seem essential for strengthening collective resilience. on the one hand, collectives are built on societal projects, aiming for new proposals and change (paraponaris et al., 2013) . they are geared towards the future and defend "a society opened to new values, broader interests and open access to knowledge" (p. 10). they are naturally opened to other social groups with whom they can confront information and knowledge in an effort towards enrichment. on the other hand, communities aim to defend their members' competences and expertise in order to support their regime of competence: their actions directly benefit their members and not the society as a whole. hence, community members can be characterized by solidarity while members of a collective are characterized by complementarity. in sum, communities naturally raise borders to external knowledge while collectives naturally aim at crossing them. our intention in this management focus is to analyze the dynamics of knowledge communities (communities of practice and collectives) with respect to innovation, agility, and the resilience of organizations. innovation will increasingly draw its main source from communities and collectives. these informal communities act as various active units, with potentially different roles, at different stages of the innovation process. given the source of creativity provided by these new organizational forms, companies should establish a strong yet respectful relationship with them in order to harvest their creative outputs and nurture the organization's formal innovative processes (sarazin et al., 2017) , especially in times of crisis. european management journal 1 how can knowledge communities' dynamics (i.e., communities of practice and collectives) foster organizational resilience? 2 how to create and animate a community, with experts, customers, and users, to develop innovation, agility, and resilience in times of crisis. 3 what are the specific characteristics of the notion of collectives? 4 how to mix these new organizational forms (i.e., communities of practice, collectives, and epistemic communities) to innovate and resist the crisis. 5 how can collectives promote a common societal cause outside the organization and obtain the adhesion and legitimacy of the greatest number? 6 how the spontaneous responses of communities and collectives can support innovations, e.g., resilience in formal hierarchical structure. 7 how can organizations support communities and collectives? 8 what are the management mechanisms (organizational levers) that support the development of innovative practices within knowing communities? 9 how to develop the interactions between formal structures (the hierarchical structures of companies) and knowing communities (i.e., communities of practice, collectives, etc.) 10 how can the productions of knowing communities be exploited, disseminated, and institutionalized through a formal structure? the kco (knowledge communities observatory) have organized a symposium for june 9e10, 2021, in the kedge business school, toulon, france, and the proposed management focus will be one of the academic outputs. this call is open to all scholars to ensure that those not involved in the kco symposium can also submit papers. full papers for consideration by the guest editors should be submitted to karine.goglio@kedgebs.com by september 25, 2021. every paper submitted to this management focus section of the european management journal (emj) must provide a clear scientific and practical contribution. conceptual or review and empirical papers will be considered. all submissions will be subject to emj's usual double-blind peer-review process and should respect the journal's guidelines. publication of the selected articles in emj's management focus section is planned for 2022. you may direct any questions to the guest editor: karine.goglio@kedgebs.com. emj is a flagship scholarly journal, publishing internationally leading research across all areas of management. emj articles challenge the status quo through critically informed empirical and theoretical investigations, and present the latest thinking and innovative research on major management topics, while still being accessible and interesting to non-specialists. emj articles are characterized by their intellectual curiosity and diverse methodological approaches, which lead to contributions that impact profoundly on management theory and practice. we welcome interdisciplinary research that synthesizes distinct research traditions to shed new light on contemporary challenges in the broad domain of european business and management. dr karine goglio-primard is an associate professor of b to b marketing at kedge business school, toulon, france. her research focuses on communities of practice that emerge in organizations and are cultivated to nurture innovation and business development. she founded the knowledge communities observatory (kco) at kedge business school, which brings together companies (crouzet, engie, expleo, laerdal medical, schneider electric, sartorius stedim, spie batignolles, etc.) and expert researchers on communities. within the kco, she analyzes how the formal structures of companies integrate the production of communities into their innovation process. her research has been published in journals such as management international, journal of business research, and management decision. dr laurent simon is a professor in the department of entrepreneurship and innovation at hec montr eal. he is also co-director of the mosaic, creativity & innovation hub, hec montr eal. he teaches courses on the management of innovation and creativity, design thinking, and business models. his research focuses on the organization, management, and performance of creative and innovative processes at the individual, collective, organizational, and territorial levels. in 2017, he co-edited the elgar companion to innovation and knowledge creation. his research has been published in journals such as organization science, journal of economic geography, industry and innovation, and management international. dr patrick cohendet is a professor in the department of international business at hec montr eal. he is also co-director of the mosaic, creativity and innovation hub, hec montr eal and co-editor of management international. his teaching, research, and publications focus on the economics and management of innovation, knowledge, and creativity. he is the author of more than 80 articles published in peer-reviewed journals and 15 books, including architectures of knowledge co-authored with ash amin. in 2017, he co-edited the elgar companion to innovation and knowledge creation. his research has been published in journals such as research policy, organization science, and industrial and corporate change. dr barak s. aharonson is a professor of strategic management and entrepreneurship at xiamen school of management, xiamen university, china, and a member of the faculty of management at coller school of business, tel aviv university, israel. he is an associate editor for the entrepreneurship and innovation section of the european management journal. his research pertains to strategy and organizational theory focusing on technology, innovation, and entrepreneurial activity; knowledge flows within and across geographic agglomerations and networks; the evolution, creation, and diffusion of technologies and innovations; and international business. his work has been published in leading journals such as the academy of management journal, organization science, research policy, and global strategy journal. etienne wenger-trayner is a global thought leader in the field of communities of practice and social learning systems. he is the author and co-author of seminal books on communities of practice, including situated learning; communities of practice: learning, meaning, and identity; cultivating communities of practice; digital habitats; and landscapes of practice. his work as researcher, author, and consultant has influenced both thinking and practice in a wide variety of fields, including business, education, government, and social theory. community, economic creativity and organization organizational learning and communities-of-call for papers / european management journal xxx (xxxx) xxx practice: toward a unified view of working, learning, and innovation la gestion des connaissances. firmes et communaut es de savoir social collectives: a partial form of organizing that sustains social innovation an introduction to the economy of the knowledge society situated learning: legitimate peripheral participation codification des connaissances et question du langage socialisation et g en eration des connaissances : distinguer les collectifs des communaut es les communaut es d'innovation underground, upperground et middle-ground : les collectifs cr eatifs et la capacit e cr eative de la ville communities of practice. learning, meaning, and identity learning in landscapes of practice: boundaries, identity, and knowledgeability in practice-based learning a guide to managing knowledge: cultivating communities of practice promoting and assessing value creation in communities and networks: a conceptual framework. open universiteit: ruud de moor centrum key: cord-328430-eme58ztj authors: sarriot, eric; shaar, ali nashat title: community ownership in primary health care—managing the intangible date: 2020-10-01 journal: glob health sci pract doi: 10.9745/ghsp-d-20-00427 sha: doc_id: 328430 cord_uid: eme58ztj although enduringly intangible, community ownership is foundational to primary health care. this intangibility is a reminder of what programs can and should do (create space for dialogue, question their own choices, expand diversity in stakeholder voices making sense of program-induced changes, including through evaluation) and what they cannot do (manage someone else’s ownership). the concept of community ownership in primary health care has a long history but remains challenged in terms of definition, measurement, and differences of perspective from practitioners on a gradient between utilitarianism and empowerment. it continues to be somewhat intangible. n although a universal definition across time and contexts may be illusory, contextual appreciation of its dynamic evolution under programmatic influences-for different stakeholders with diverse agendas-is accessible to evaluation and learning. n no one can "manage" someone else's ownership, but programs can reject hubris and tokenism by intentionally questioning their unavoidable impact on community ownership and whether they foster it through meaningful dialogue and "sense-making" with local stakeholders. see related article by fontanet et al. i n this issue of ghsp, fontanet et al. 1 invite us to return to a concept that has existed since early discussions of community medicine 2 and primary health care 3 : community ownership in health. many of us who work in global health have felt and seen the excitement and sense of possibility when communities took charge, made a project "their own," innovated to find contextual solutions, and generated energy and hope in addition to buy-in for a lifesaving or health-promoting intervention. in 1992, one of this article's authors witnessed how heavy rains had damaged a clinic serving the poor population of jiftlik in the jordan valley. without institutional funds to rehabilitate the structure, the village residents felt a sense of ownership and accountability and restored the clinic themselves, and this clinic is still providing services in 2020. the literature is rich with case studies like this. [4] [5] [6] as critical as community ownership is-and even foundational for many-it also appears to remain somewhat intangible, possibly impractical for some, and certainly complex for all. we consider some of the reasons for this quandary. the first stumbling block with community ownership is definitional. this naturally starts with, "what is community really?" this question is followed by-as we generally discuss social processes writ large rather than physical assets 7 -"what is ownership?" we will satisfy ourselves for now with the idea that a community can be a geographically and demographically defined group of people, a network of people with a common agenda or challenge (illness), and/or most likely a combination of both of these, which creates the possibility of being in a community but outside of important social relationships. fontanet et al. 1 remind us of the looseness of the concept of community ownership and frame it first under the paris declaration of aid effectiveness 8 ; community ownership would fit with country ownership, albeit on a different, more local scale. (oxfam and save the children, for their part, see a shift in emphasis from community to country as "a more state-centric form of ownership." 9 ) community ownership is sometimes defined through requirements for ownership, including capacity, empowerment, leadership, value found in the provision of a service, aspirations, and participation, or through consequences of ownership, including participation (again), financial commitment, contributions, and organization membership. [10] [11] [12] [13] [14] [15] these definitions can sometimes appear tautological-that ownership is defined by the fact of owning or institutionalizing a process or a goal. the literature associates ownership with sustainability of activities and outcomes, a means to achieve cultural adaptation for effective intervention models and to build problem-solving capacity. 10, 12, 16 ownership can be described as a requirement to build community capacity in a health promotion effort, yet capacity can be presented a save the children, washington dc, usa. b palestinian child institute, an-najah national university, nablus, palestine. correspondence to eric sarriot (esarriot@savechildren.org). global health: science and practice 2020 | volume 8 | number 3 as a requirement of ownership. 10 whichever way the causal link is created, it is presented on the path to effective and sustainable health interventions. countless evaluation reports have also associated failure of achievement and sustainability to the lack of community ownership generated by external projects. in the past, the concept has also been associated to financial contributions by communities, 17 something critically revised through the universal health coverage agenda. much like the concept of participation, ownership lives in the tension between utilitarianism and empowerment, 18 bridging over to human rights, democratic, and humanist perspectives on development processes. the ottawa charter for health promotion encouraged a process for enabling communities to increase control over and improve health and notably stated 19 : health promotion works through concrete and effective community action in setting priorities, making decisions, planning strategies and implementing them to achieve better health. at the heart of this process is the empowerment of communities-their ownership and control of their own endeavors and destinies. advancing community ownership faces at least 3 other challenges. although we support and believe in the ottawa charter's vision of seeking to increase people's control over their own health, we must also acknowledge that calls for ownership and "full participation" (as in the recent astana statement 20 ) sometimes contain an element of idealism that pragmatists can occasionally point out with a wink or with cynicism in the face of harsh "field" realities. community members may in fact be satisfied sometimes by simply being clients of health services. demands for social accountability surge when quality, equity, responsiveness, and access conditions are not met. but when they are, people might satisfy themselves with utilizing, rather than owning, a service. indeed, public health problems are defined in a context, and these "problems-in-context" demand specific solution configurations, not all of which require the same level of social engagement. people responding to an acute threat might not perceive ownership as an immediate priority. of course, the global health community had to rapidly re-discover the importance of building a response with communities in the ebola emergency and efforts to eradicate polio. 21, 22 the current global challenges with vaccine acceptance and the coronavirus disease (covid-19) situation 23 are also signaling that some form of ownership is required for scale, sustainability, and impact of interventions. still, we must also acknowledge that many shortterm bets can be won with money and energy invested in proximal determinants of health. ownership is critical but may be a distal determinant of success. we undermine our own advocacy if we appear to take for granted the value of technicity, policy, and organization in solving health challenges and present ownership in absolute terms. why are we asking about ownership ultimately? because although they are always well-intended, not infrequently effective, and sometimes sustainable, our external projects inherently displace power and ownership from "natural" social systems (if there is such a thing). we punctuate an equilibrium, if not of ownership, at least of acceptance or resignation to a social baseline, but unless some new equilibrium of ownership is found between diverse stakeholders, the system will be attracted back to its baseline or some other suboptimal state. ignoring this tension poses a great risk of hubris. we know the stereotype: experts can come and "give messages," tell people what the evidence says, and incentivize them to follow their plan, while failing to listen honestly and with respect to the local and community-appropriate ideas for adaptation of the approaches. white elephants are built. without being a cynic, simply having self-satisfaction with giving token respect for the value of community ownership or coopting can lead to asking the wrong questions, in other words, having a poor definition of what problems really need to be addressed in context. policy makers close a market to create social distancing; populations protest because they weigh differently an epidemiological risk against the necessity of feeding their family; the market reopens, but no effective community-owned risk reduction solution has been developed. although the concern about projects' displacement of ownership may have been born out of an evolution of international programs away from colonialism, "do-gooding," and hubris, it also applies to any national or regional program trying to reach remote, poor, minority, or neglected areas. displacement of ownership is not an we undermine our own advocacy if we appear to take for granted the value of technicity, policy, and organization in solving health challenges and present ownership in absolute terms. international development problem; it is a universal central-to-local (resource rich to resource poor) development problem. and while "we" question "their" ownership, we are rarely fully accountable for what role and agency we choose to keep to ourselves as we transition. 24 we already mentioned different dimensions through which ownership has been framed. efforts at measurement naturally must also be multidimensional, 9 but this is not the greatest measurement challenge. research may be able to draw conclusions from a distance on the ownership demonstrated by various communities and stakeholders, but program evaluation-seeking to assess what allows or hinders ownership during implementation-must be carried out with the stakeholders or else be meaningless. as is the case for assessing institutional capacity, assessing or measuring ownership requires that the "owners" at least acquiesce to the process. a thought experiment can make the point. how would our employers or neighbors react to an outsider knocking on their virtual door to measure their ownership of a stated goal? while accepting to step on the scale does not influence the weight that will be posted on the scale, the measurement of a community's ownership has community prerequisites in terms of buy-in and boundary decisions (who is the community and who is asking the question?). the prerequisites for measuring ownership are not independent of the ownership variable. it is noteworthy that fontanet et al. allowed different stakeholders to define their ownership differently. elements of subjectivity seem unavoidable-not something typically desired in project performance management. this subjectivity comes with management challenges. projects try to manage by results and give evidence for achievements. we develop indicators that are as objective and reliable as possible. but when it comes to measuring changes in a social system, our log frames and theories of change are challenged to capture the interaction between our programs and social dynamics over time. 25 we say that we "cannot manage it if we cannot measure it," but given the nature of the question, can we ever manage the ownership of someone else? then, what are we trying to measure, who should be doing the measurement, and over what timeframe, if ownership evolves on a different timeline than service outputs? last and not least, ownership in a complex social system is always changing (dynamic) and can be affected by small changes in interpersonal relationships, services, or operational rules. a new equilibrium between stakeholders comes with new rules and boundaries, and questions may be raised about the ownership allowed for newcomers. 11 the stakeholders of community ownership will change, their relationships will change, their perspectives will evolve, as shown by fontanet et al. over just a 24-month period. this leaves us with a series of limitations: we should assess our impact on community ownership, but our measurement is likely to be subjective and flawed. we want to be accountable for progress, but community ownership is precisely about things that we must let go of. we should be concerned about community ownership, but we still cannot totally define it. its local definition depends on who sits around the table. it may change and change substantially based on small evolutions of the problem-in-context. should we just abandon all hope? perhaps not. social scientists will continue to enrich our understanding by dissecting ownership for different problems and contexts. the measurement challenge may be like that of social capital, for which operational measures can be defined in different contexts, even if a set of universal measures for all contexts may remain out of reach. 26 fontanet et al. 1 interestingly circumvent some of the challenges by exploring with qualitative rigor the perceptions of ownership, providing substance to the concept from stakeholders, who have different but compatible definitions of what ownership is to them. the intangible is not made totally tangible, but the local meaning for stakeholders provides guidance to continue developing a program. another role of research may thus be to provide substance for advocacy and to challenge approaches that deny agency to marginalized communities. not all programs have access to strong research capability. however, they can use monitoring, learning, evaluation, and accountability tools to limit disrupting ownership or even to foster it. promoting community ownership and learning about its development may be more akin to generating new social equilibria than planning for the delivery of a discrete outcome. it demands genuine interactions, creating enabling conditions and spaces for incremental changes, and building shared values. these ideas are not far from the concept of "harnessing complexity" in complex social and institutional systems. 27 it quite possibly will require monitoring "us"-how we use our money, power, and time, and maybe addressing more critically when we must act and when we must choose to use restraint-as much as measuring "their" ownership. sustainability-conscious public health practitioners, whether national or international, may not need to worry about precisely measuring the state of community ownership, but to focus more on which agents of the local system are taking agency, how much, and how diverse voices give meaning to tangible changes and intangible perceptions about structures, services, actions, relationships, and values. if we are intent on finding viable long-term solutions to primary health care challenges with a view of sustainable development, 28 transition, and the "journey to self-reliance," 29 the greatest mistake may be failing to critically engage in questioning our projects' effects on community ownership and to mistrust the ability of communities to be agents of change. as messy as it may be. a qualitative exploration of community ownership of a maternity waiting home model in rural zambia community medicine: teaching, research and health care. appleton-century-crofts educational division world health organization institutionalizing communityfocused maternal, newborn, and child health strategies to strengthen health systems: a new framework for the sustainable development goal era comprehensive review of the evidence regarding the effectiveness of community-based primary health care in improving maternal, neonatal and child health: 8. summary and recommendations of the expert panel just and lasting change: when communities own their futures how does community-led total sanitation (clts) affect latrine ownership? a quantitative case study from mozambique declaration on aid effectiveness and the accra agenda for action the power of ownership: transforming us foreign assistance. save the children, oxfam community capacity as means to improved health practices and an end in itself: evidence from a multi-stage study. int q community health educ community participation in health systems research: a systematic review assessing the state of research, the nature of interventions involved and the features of engagement with communities how do community health committees contribute to capacity building for maternal and child health? a realist evaluation protocol design of a community ownership and preparedness index: using data to inform the capacity development of community-based groups community participation: lessons for maternal, newborn, and child health beliefs, behaviors, and perceptions of community-led total sanitation and their relation to improved sanitation in rural zambia unlocking community capabilities across health systems in low-and middleincome countries: lessons learned from research and reflective practice implementation of the bamako initiative: strategies in benin and guinea community participation in health: perpetual allure, persistent challenge ottawa charter for health promotion. who the political economy of the ebola virus disease (evd); taking individual and community ownership in the prevention and control of evd community engagement, ownership, and civil society organizations in polio eradication vaccine hesitancy: the next challenge in the fight against covid-19 monitoring and evaluating the transition of large-scale programs in global health hubris, humility and humanity: expanding evidence approaches for improving and sustaining community health programmes social capital and health in the least developed countries: a critical review of the literature and implications for a future research agenda united nations development program (undp) united states agency for international development. the journey to self-reliance. helping countries to solve their own development challenges acknowledgments: thank you to erica nelson, lenette golding, and judy sarriot for technical and editorial inputs. competing interests: none declared. key: cord-028685-b1eju2z7 authors: fuentes, ivett; pina, arian; nápoles, gonzalo; arco, leticia; vanhoof, koen title: rough net approach for community detection analysis in complex networks date: 2020-06-10 journal: rough sets doi: 10.1007/978-3-030-52705-1_30 sha: doc_id: 28685 cord_uid: b1eju2z7 rough set theory has many interesting applications in circumstances characterized by vagueness. in this paper, the applications of rough set theory in community detection analysis are discussed based on the rough net definition. we will focus the application of rough net on community detection validity in both monoplex and multiplex networks. also, the topological evolution estimation between adjacent layers in dynamic networks is discussed and a new community interaction visualization approach combining both complex network representation and rough net definition is adopted to interpret the community structure. we provide some examples that illustrate how the rough net definition can be used to analyze the properties of the community structure in real-world networks, including dynamic networks. complex networks have proved to be a useful tool to model a variety of complex systems in different domains including sociology, biology, ethology and computer science. most studies until recently have focused on analyzing simple static networks, named monoplex networks [7, 17, 18] . however, most of real-world complex networks are dynamics. for that reason, multiplex networks have been recently proposed as a mean to capture this high level complexity in real-world complex systems over time [19] . in both monoplex and multiplex networks the key feature of the analysis is the community structure detection [11, 19] . community detection (cd) analysis consists of identifying dense subgraphs whose nodes are densely connected within itself, but sparsely connected with the rest of the network [9] . cd in monoplex networks is a very similar task to classical clustering, with one main difference though. when considering complex networks, the objects of interest are nodes, and the information used to perform the partition is the network topology. in other words, instead of considering some individual information (attributes) like for clustering analysis, cd algorithms take advantage of the relational one (links). however, the result is the same in both: a partition of objects (nodes), which is called community structure [9] . several cd methods have been proposed for monoplex networks [7, 8, 12, [16] [17] [18] . also, different approaches have been recently emerged to cope with this problem in the context of multiplex networks [10, 11] with the purpose of obtaining a unique community structure involving all interactions throughout the layers. we can classify latter existing approaches into two broad classes: (i) by transforming into a problem of cd in simple networks [6, 9] or (ii) by extending existing algorithms to deal directly with multiplex networks [3, 10] . however, the high-level complexity in real-world networks in terms of the number of nodes, links and layers, and the unknown reference of classification in real domain convert the evaluation of cd in a very difficult task. to solve this problem, several quality measures (internal and external) have emerged [2, 13] . due to the performance may be judged differently depending on which measure is used, several measures should be used to be more confident in results. although, the modularity is the most widely used, it suffers the resolution limit problem [9] . another goal of the cd analysis is the understanding of the structure evolution in dynamic networks, which is a special type of multiplex that requires not only discovering the structure but also offering interpretability about the structure changes. rough set theory (rst), introduced by pawlak [15] , has often proved to be an excellent tool for analyzing the quality of information, which means inconsistency or ambiguity that follows from information granulation in a knowledge system [14] . to apply the advantages of rst in some fields of cd analysis, the goal of our research is to define the new rough net concept. rough net is defined starting from a community structure discovered by cd algorithms applied to monoplex or multiplex networks. this concept allows us obtaining the upper and lower approximations of each community, as well as, their accuracy and quality. in this paper, we will focus the application of the rough net concept on cd validity and topological evolution estimation in dynamic networks. also, this concept supports visualizing the interactions of the detected communities. this paper is organized as follows. section 2 presents the general concepts about the extended rst and its measures for evaluating decision systems. we propose the definition of rough net in sect. 3. section 4 explains the applications of rough net in the community detection analysis in complex networks. besides, a new approach for visualizing the interactions between communities based on rough net is provided in sect. 4. in sect. 5, we illustrate how the rough net definition can be used to analyze the properties of the community structure in real-world networks, including dynamic networks. finally, sect. 6 concludes the paper and discusses future research. the rough sets philosophy is based on the assumption that with every object of the universe u there is associated a certain amount of knowledge expressed through some attributes a used for object description. objects having the same description are indiscernible with respect to the available information. the indiscernibility relation r induces a partition of the universe into blocks of indiscernible objects resulting in information granulation, that can be used to build knowledge. the extended rst considers that objects which are not indiscernible but similar can be grouped in the same class [14] . the aim is to construct a similarity relation r from the relation r by relaxing the original indiscernibility conditions. this relaxation can be performed in many ways, thus giving many possible definitions for similarity. due to that r is not imposed to be symmetric and transitive, an object may belong to different similarity classes simultaneously. it means that r induces a covering on u instead of a partition. however, any similarity relation is reflexive. the rough approximation of a set x ⊆ u , using the similarity relation r , has been introduced as a pair of sets called rlower (r * ) and r -upper (r * ) approximations of x. a general definition of these approximations which can handle any reflexive r are defined respectively by eqs. (1) and (2). the extended rst offers some measures to analyze decision systems, such as the accuracy and quality of approximation and quality of classification measures. the accuracy of approximation of a rough set x, where |x| denotes the cardinality of x = ∅, offers a numerical characterization of x. equation (3) formalizes this measure such that 0 ≤ α(x) ≤ 1. if α(x) = 1, x is crisp (exact) with respect to the set of attributes, if α(x) < 1, x is rough (vague) with respect to the set of attributes. the quality of approximation formalized in eq. (4) expresses the percentage of objects which can be correctly classified into the class x. [14] . quality of classification expresses the proportion of objects which can be correctly classified in the system; equation (5) formalizes this coefficient where c 1 , · · · , c m correspond to the decision classes of the decision system ds. notice that if the quality of classification value is equal to 1, then ds is consistent, otherwise is inconsistent [14] . equation (6) shows the accuracy of classification, which measures the average the accuracy per classes with different importance levels. its weighted version is formalized in eq (7) [4] . m onoplex (simple) networks can be represented as graphs g = (v, e) where v represents the vertices (nodes) and e represents the edges (interactions) between these nodes in the network. m ultiplex networks have multiple layers, where each one is a monoplex network. formally, a multiplex network can be defined as a triplet < v, e, l > where e = e i such that e i corresponds to the interactions on layer i-th and l is the number of layers. this extension of graph model is powerful enough though to allow modeling different types of networks including dynamic and attributed networks [9] . cd algorithms exploit the topological structure for discovering a collection of dense subgraphs (communities). several multiplex cd approaches emphasize on how to obtain a unique community structure throughout all layers, by considering as similar nodes that ones with the same behavior in most of the layers [3, 10] . in the context of dynamic networks, the goal is to detect the conformation by layers for characterizing the evolutionary or stationary properties of the cd structures. due to the quality of the community structure may be judged differently depending on which measure is used, to be more confident in results several measures should be used [9] . in this section, we recall some basic notions related to the definition of the extension of rst in complex networks. also, we will focus on the introduction of the rough net concept by extrapolating these notions to the analysis of the consistency of the detected communities in complex networks. this concept supports to validate, visualize, interpret and understand the communities and also their evolution. besides, it has a potential application in labeling and refining the detected communities. as was mentioned, it is necessary to start from the definition of the decision system, the similarity relation, and the basic concepts of lower and upper approximations. we use a similarity relation r in our definition of rough net, because two nodes of v can be similar but not equal. the similarity class of the node x is denoted by r (x), as shown in eq. (8) . the r -lower and r -upper approximations for each similarity class are computed by eqs. (1) and (2) respectively. there is a variety of distances and similarities for comparing nodes [1] , such as salton, hub depressed index (hdi), hub promoted index (hpi), similarities based on the topological structure, and dice and cosine coefficients which capture the attribute relations. in this paper, we use the jaccard similarity for computing the similarities based on the topological structure because it has the attraction of simplicity and normalization. the jaccard similarity, which also allows us to emphasize the network topology necessary to apply rst in complex networks, is defined in eq. (9), where γ (x) denotes the neighborhood of the node x including it. r an adjacency tensor for a monoplex (i.e., single layer) network can be reduced to an adjacency matrix. the topological relation between nodes comprises an |v | × |v | adjacency matrix m , in which each entry m i,j indicates the relationships between nodes i and j weighted or not. the weight can be obtained as a result of the application of both a flattening process in a multi-relational network or a network construction schema when we want to apply network-based learning methods to vector-based datasets. if we apply some cd algorithm to this adjacency matrix, then we can consider the combination of the topological structure and the cd results as a decision system where a is a finite set of topological or non-topological features and d / ∈ a is the decision attribute resulting from the detected communities over the network. m ultiplex are powerful enough though to allow modeling different types of networks including multi-relational, attributed and dynamic networks [11] . note that multiplex networks explicitly incorporate multiple channels of connectivity in which entities can have a different set of neighbors in each layer. in a dynamic network each layer corresponds to the network state at a given time-stamp (or each layer represents a snapshot). like a time-series analysis, if attributes are captured in each time, a complex network can be represented as a dynamic network [19] . an adjacency tensor for a dynamic network with dimension l, which corresponds to the number of layers, represents a collection of adjacency matrices. the topological interaction between nodes within each layer k-th of a multiplex network comprises an |v | × |v | adjacency matrix m k , in which each entry m k ij indicates the relationships between nodes i and j in the k-th layer. if we apply a cd algorithm to the whole multiplex network topology by considering multiplex cd approaches [10, 19] in order to compute the unique final community structure, then we can consider the application of rst concepts over the multiplex network as the aggregation of the application of the rst concepts over each layer k-th. consequently, the decision system for the k-th layer is the combination of the topological structure m k and the cd results, formalized as where a k is a finite set of topological or non-topological features in the k-th layer and d / ∈ a is the decision attribute resulting from the detected communities in the multiplex topology (i.e., each node and their counterpart in each layer represent a unique node that belongs to a specific community). besides, it is possible to transform a multiplex into a monoplex network by a flattening process. the main flatten approaches are the binary flatten, the weighted flatten and another based on deep learning [10] . taking into account these variants, we can consider the combination of the topological structure of the transformed network and the cd results as a decision system ds monoplex = (v, a ∪ d), where a = k∈l a k is a finite set of topological or non-topological features that characterize the networks and d / ∈ a is the decision attribute resulting from the detected communities. the multiple instance or ensemble similarity measures are powerful for computing the similarity between nodes taking into account the similarity per layers (contexts). in this section, we describe the application of rough net in important tasks of the cd analysis: the validation and visualization of detected communities and their interactions, and the evolutionary estimation in dynamic networks. a community can be defined as a subgraph whose nodes are densely connected within itself, but sparsely connected with the rest of the network, though other patterns are possible. the existence of communities implies that nodes interact more strongly with the other members of their community than they do with nodes of the other communities. consequently, there is a preferential linking pattern between nodes of the same community (being modularity [13] one of the most used internal measures [9] ). this is the reason why link densities end up being higher within communities than between them. although the modularity is the most widely quality measure used in complex networks, it suffers the resolution limit problem [9] and, therefore, it is unable to judge in a correct way community structure of the networks with small communities or where communities may be very heterogeneous in size, especially if the network is large. several methods and measures have been proposed to detect and evaluate communities in both monoplex and multiplex networks [2, 3, 13] . as well as modularity, normalized mutual information (nmi), adjusted rand (ar), rand, variation of information (vi) measures [2] are widely used, but the latter ones need an obtain the similarity class r k (x) based on equation (8) 12: for x in c[k] do 13: calculate r k * (x) and r * k (x) approximations (see equations (1)-(2)) 14: calculate α(x) and γ(x) approximation measures (see equations (3) external reference classification to produce a result. however, it is very difficult to evaluate a community result because the major of complex networks occur in real world situations since reference classifications are usually not available. we propose to use quality, accuracy and weighted accuracy of classification measures described in sect. 2 to validate community results, taking into account the application of accuracy and quality of approximation measures to validate each community structure. aiming at providing more insights about the validation, we provide a general procedure based on rough net. notice that r k (x) is computed by considering the attributes or topological features of networks in the k-th layer, by using eq. (8). algorithm 1 allows us to measure the quality of the community structure using rough net, by considering the quality and precision of each community. rough net allows judging the quality of the cd by measuring the vagueness of each community. for that reason, if boundary regions are smaller, then we will obtain better results of quality, accuracy and weighted accuracy of classification measures. a huge of real-world complex networks are dynamic in nature and change over time. the change can be usually observed in the birth or death of interactions within the network over time. in a dynamic network is expected that nodes of the same community have a higher probability to form links with their partners than input: two-consecutive layers cl of g, a threshold ξ and a similarity s output: the evolutionary estimations obtain the similarity class r k−i (x) based on equation (8) 8: calculate r k−i * (x) and r * k−i (x) approximations (see equations (1)-(2)) 9: calculate α k−i (x) and γ k−i (x) measures (see equations (3) with other nodes [19] . for that reason, the key feature of the community detection analysis in dynamic networks is the evolution of communities over time. several methods have been proposed to detect these communities over time for specific time-stamp windows [3, 10] . often more than one community structure is required to judge if the network topology has suffered transformation over time for specific window size. to the best of our knowledge, there is no measure able which captures this aspect. for that reason, in this paper, we propose measures based on the average of quality, accuracy and weighted accuracy of classification for estimating in a real number the change level during a specific window timestamp. we need to consider two-consecutive layers for computing the quality, accuracy and weighted accuracy of classification measures in the evolutionary estimation (see algorithm 2) . for that reason, we need to apply twice the rough net concept for each pair of layers. the former rough net application is based on the decision system ds = (v, a k ∪ d k−1 ), where a k is a set of topological attributes in the layer k and d k−1 / ∈ a k is the result of the community detection algorithm in the layer k − 1 (decision attribute). the latter rough net application is based on the decision system ds = (v, a k−1 ∪ d k ), where a k−1 is a set of topological attributes in the layer k − 1 and d k / ∈ a k−1 is the result of the community detection algorithm in the layer k (decision attribute). the measures can be applied over a window size k by considering the aggregation of the quality classification between all pairs of consecutive (adjacency) layers. values nearer to 0 express the topology is evolving over time. in many applications more than a unique real value that expresses the quality of the community conformation is required for the understanding of the interactions throughout the networks. besides, real-world complex networks usually are input: a complex network g, detected communities, a threshold ξ and a similarity s output: community network representation 1: create an empty network g (v , e ) 2: for x in v do 3: obtain the similarity class r (x) based on equation (8) 4: end for 5: for x in communities(g, d) do 6: calculate r * (x) and r * (x) approximations (see equations (1)-(2)) 7: calculate α(x) and γ(x) approximation measures (see equations (3)-(4)) 8: add a new node x where the size corresponds to quality or accuracy 9: end for 10: for x, y in communities(g), x = y do 11: calculate the similarity sbn between communities x-th and y -th 12: add a new edge (i, y, wxy ) where the weighted wij = sbn (x, y ) 13: end for composed by many nodes, edges, and communities, making difficult to interpret the obtained results. thus, we propose a new approach for visualizing the interactions between communities taking into account the quality of the community structure by using the combination of the rough net definition and the complex network representation. our proposal, formalized in algorithm 3, allows us to represent the quality of the community structure in an interpretable way. the similarity measure used for weighted the interactions between communities in the network representation is formalized in eq. (10). the s bn (x, y ) captures the proportion of nodes members of the community x, which cannot be unambiguously classified into this community but belong to the community y and vice-versa. the above idea is computed based on the boundary region bn of both communities x and y . the rough net approach allows us to evaluate the interaction between the communities and its visualization facilitates interpretability. in turn, it helps experts redistribute communities and change granularity based on the application domain requirements. for illustrating the performance of the rough net definition in the community detection analysis, we apply it to three networks, two known to have monoplex topology and the third multiplex one. to be more confident in results, we should use several measures for judging the performance of a cd algorithm [2, 5] .thus, we compare our approach to validate detected communities (i.e., accuracy and quality of classification) with the most popular internal and external measures used for community detection validity: modularity, ar, nmi, rand, vi [2] . modularity [13] quantifies when the division is a good one, in the sense of having many within-community edges. it takes its largest value (1) in the trivial case where all nodes belong to a single community. a value near to 1 indicates strong community structure in the network. all other mentioned measures need external references for operating. all measures except vi, express the best result though values near to 1. for that reason, we use the notation vic for denoting the complement of vi measure (i.e., v ic = 1 − v i). zachary is the much-discussed network 1 of friendships between 34 members of a karate-club at a us university. figure 1 shows the community structures reported by the application of the standard cd algorithms label propagation (lp), multilevel louvain (lv), fast greedy optimization (fgo), leading eigenvector (ev), infomap (im) and walktrap (wt) to the zachary network. each community has been identified with a different colour. these algorithms detect communities, which mostly not correspond perfectly to the reference communities, except the lp algorithm which identically matches. for that reason, we can affirm that the lp algorithm reported the best division. however, in fig. 2 we can observe that the modularity values not distinguish the lp as the best conformation of nodes into communities, while the proposed accuracy and quality of classification measures based on the rough net definition, assign the higher value to the lp conformation regardless of the used threshold. on the other hand, our measures grant the lowest quality results for the community structure obtained by the ev algorithm as expected. notice that fgo and ev assign the orange node with high centrality in the orange community structure in a wrong manner. we can notice that most neighbors of this node are in another community. indeed, the fgo and wt are the following lowest results reported by our measures. figure 3 shows the performance reported by the application of the standard community detection algorithms before mentioned by using the proposed quality measures and the external ones. all measures exhibit the same monotony behaviors with independence of the selected similarity threshold ξ. our measures have the advantage that are internal and behave similarly to external measures. the jazz network 2 represents the collaboration between jazz musicians, where each node represents a jazz musician and interactions denote that two musicians are playing together in a band. six cd algorithms were applied to this network with the objective of subsequently exploring the behavior of validity measures. figure 4 displays that lp obtains a partition in which the number of interactions shared between nodes of different communities is smaller than the number of interactions shared between the communities obtained by the fgo algorithm. however, this behavior is not reflected in the estimation of the modularity values, while it manages to be captured by the proposed quality measures, as shown in fig. 5 . besides, the number of interactions shared between the communities detected by the algorithms lv, fgo, and ev is much greater than the number of interactions shared between the communities detected by the algorithms lp, wt, and im. therefore, this behavior was expected to be captured through the rough net definition. figure 5 shows that the results reported by our measures coincide with the expected results. on the one hand, we can observe that our quality measures exhibit a better performance than the modularity measure in this example. our measures also capture the presence of outliers, this is the reason why the community structure reported by the wt algorithm is higher than the obtained by the lp algorithm. caenorhabditis elegans connectome (celegans) is a multiplex network 3 that consists of layers corresponding to different synaptic junctions: electric (elec-trj), chemical monadic (monosyn), and polyadic (polysyn). figure 6 shows the mapping of the community structure in each network layer, which has been obtained by the application of the muxlod cd algorithm [10] . notice that a strong community structure result must correspond to a structure of densely connected subgraphs in each network layer. this reflexion property is not evident for these communities in the celegans network. for that reason, both the modularity and the proposed quality community detection measures obtain low results (modularity = 0.07, α(ξ = 0.25) = 0.24 and γ(ξ = 0.25) = 0.14). figure 7 shows the interactions between the communities in each layer by considering the muxlod community structure and the algorithm described in sect. 4.3. the community networks show high interconnections and as expected, the results of the quality measures are low. figure 7 shows that the topologies of the polysyn and electrj layers do not match exactly. in this sense, let us suppose without loss of generalization, that we want to estimate if there has been a change in the topology considering these layers as consecutive. to estimate these results, we apply the algorithm described in sect. 4.2. figure 8 shows the modularity, accuracy and quality of classification obtained values, which reflect that the community structure between layers does not completely match, so it can be concluded that the topology has evolved (changed). in this paper, we have described new quality measures for exploratory analysis of community structure in both monoplex and multiplex networks based on the rough net definition. the applications of rough net in community detection analysis demonstrate the potential of the proposed measures for judging the community detection quality. rough net allows us to asses the detected communities without requiring the referenced structure. besides, the proposed evolutionary estimation and the new approach for discovering the interactions between communities allows to the experts a deep understanding of complex real systems mainly based on the visualization of interactions. for the future work, we propose to extend the applications of rough net to the estimation of the community structure in the next time-stamp based on the refinement between adjacent layers in dynamic networks. a new scalable leader-community detection approach for community detection in social networks surprise maximization reveals the community structure of complex networks community detection in multidimensional networks rough text assiting text mining: focus on document clustering validity a novel community detection algorithm based on simplification of complex networks abacus: frequent pattern mining-based community discovery in multidimensional networks fast unfolding of communities in large networks finding community structure in very large networks mathematical formulation of multilayer networks muma: a multiplex network analysis library multiplex network mining: a brief survey finding community structure in networks using the eigenvectors of matrices mixture models and exploratory analysis in networks incomplete information: rough set analysis rough set theory and its applications to data analysis computing communities in large networks using random walks near linear time algorithm to detect community structures in large-scale networks maps of information flow reveal community structure in complex networks. arxiv preprint physics complex network approaches to nonlinear time series analysis key: cord-214006-0w6bqrox authors: aghdam, atae rezaei; watson, jason; miah, shah j; cliff, cynthia title: towards empowering diabetic patients: a perspective on self-management in the context of a group-based education program date: 2020-10-26 journal: nan doi: nan sha: doc_id: 214006 cord_uid: 0w6bqrox this paper provides a novel framework for maximizing the effectiveness of the diabetes group education program, which could be generalized in any similar problem context. diabetes is recognised as the world's fastest-growing chronic disease (australia 2020; lovic et al. 2020) . according to the international diabetes federation (idf), by 2040 one adult in ten will have diabetes (642 million) (australia 2020 ). diabetes is a chronic and progressive disease, which needs continuing self-management and self-awareness for a lifestyle change (kjellsdotter et al. 2020) . selfmanagement is one of the most key success factors impacting the progression of type-2 diabetes for patients, as the decisions that they make daily considerably impact their health outcomes (funnell and anderson 2004) . patients play a pivotal role in their self-care as they are doing more than 95% of their diabetes care outside of medical centres or at home (su et al. 2019) . ohcs as affordable and easily accessible 24/7 services, can facilitate self-management of diabetics by offering health-related advice and stories, social and emotional support (aghdam et al. 2018 ). an ohc refers to a group of people who interact with each other in an online platform about similar health issues (wang et al. 2017) . due to the fact that people tend to trust others who are in a similar situation rather than organisations, businesses, or government figures and media, it stands to reason that the content shared by peers in ohcs has potential to encourage community members to engage in health-related online activities (irshad et al. 2013; litchman and edelman 2019) . participating in ohcs progressively transforms patients from passive recipients of healthcare services to active agents (bragazzi 2013) . as active agents, patients can access, share and integrate their resources, sharing their experiences and stories, and emotionally supporting peers to achieve their health-related goals (forouzandeh and aghdam 2019) (aghdam et al. 2020) . the empowerment of patients improves the patients' role in co-creation, co-designing, and co-delivering health services (ciasullo et al. 2017) . this is essentially a reality for people with chronic disease such as diabetes patients who need informational and emotional supports that allow them to be successful in their disease self-management (litchman and edelman 2019) . in this regard, the diabetes education program has been a focus of prior research as a specific intervention that supports diabetes self-management (findlay-white et al. 2020) . ohcs provide opportunities for members to exchange new ideas, knowledge and information about diabetes selfmanagement, functioning as a bridge among people with type-2 diabetes and healthcare professionals and providing online discussion platforms to brainstorm potential solutions (sim et al. 2008) . as such, this study aims to investigate the potential practices of online diabetes communities to address the following question; how can an online diabetes community empower patients in context of a diabetes group education program (dgep)? the remainder of this paper is organised as follows; the next section describes the background of the literature. the following section explains the research methodology followed by the trustworthiness process. the discussion section provides a comprehensive overview of the contributions of the study from both theoretical and practical perspectives and the final section synthesises the findings and provides avenues for future research. chronic disease is generally of long duration, slow progression, and impacts the quality of life (martz et al. 2007 ). the care for people with chronic diseases such as type-2 diabetes is often complex and requires self-management as an essential element of the chronic care model (wagner et al. 2001 ). self-management includes actions and behaviours to manage the psychical, emotional, and social effects of the chronic disease (adams et al. 2004 ). one of the key methods for self-management of chronic disease and improved health outcomes is patient education (ellis et al. 2004; mensing and norris 2003) . patient education is the keystone of chronic disease self-management and is significant in achieving positive health outcomes for chronic disease patients (ellis et al. 2004; mensing and norris 2003) . patients need support, education, guidance and empowerment from their healthcare providers to tackle barriers to effective self-management (diabetes 2009 ). studies contended that participation in self-management courses also improves patient confidence, self-management skills and ability to self-manage their chronic disease, and improves the quality of life (turner et al. 2015) . diabetes group education programs typically assist patients to achieve knowledge and skills and confidence to manage their diabetes as well as opportunities to interact with peers and healthcare providers (jonkman et al. 2016) . group interactions facilitate further learning and raise motivation by interacting and learning from the experience of others (odgers-jewell et al. 2017) . research shows that diabetes group-based education programs benefit patients who derive social and emotional support from discussion with others (steinsbekk et al. 2012 ). this type of active participation by australasian conference on information systems aghdam & watson 2020, wellington towards empowering diabetic patients patients in their health journey leads to value co-creation (osei-frimpong et al. 2015) . in the healthcare context value co-creation refers to "activities centered around the individual patients or in collaboration with numbers of the service delivery network including the patient, family, friends, other patients, health professionals and the outside community" (mccoll-kennedy et al. 2012, p. 6) . value is co-created synergistically and digital health platforms such as ohcs act as a coordinating device between community members (smedlund 2016) . thus, digital health platforms such as ohcs are ideal places for value co-creation (aghdam et al. 2020; kamalpour et al. 2020) . because of the nature of the dgep, patients face three different stages during their health journey; (1) prior to joining, (2) during the program, and (3) after the program. we adapted customer-dominant logic (cdl) to divide the customer journey into these three phases. in fact, cdl argues that customers control the service situation and control is a relevant issue in many domains, and due to progressively empowered customers (seybold 2001) , this direction will most likely continue in the future (heinonen and strandvik 2015) . accordingly, in the healthcare domain, empowering patients in ohcs can activate value co-creation behaviour among stakeholders (litchman et al. 2018 ). as diabetes self-management requires a patient-centred approach (funnell et al. 2007) , in particular for a demand-driven decision making (e.g. in clinical settings -miah, 2013) and to date, the most successful diabetes self-management group activities and classes have been evaluated based on empowerment theory (heisler 2010) , our study applied empowerment theory in the context of ohcs and a diabetes group education program. empowerment theory contends that actions, activities or structures might be empowering and the outcome of such process leads to being empowered (zimmerman 2000) . according to empowerment theory, people need opportunities to become active in community decision-making to improve their quality of life. as such, we leverage an affordable and easily accessible 24/7 digital health platform such as ohcs to facilitate the process of selfmanagement through informational, social, and emotional support. the proposed framework goes beyond the existing system-centric approaches to a new mode of conceptualisation and practice, which focuses on interactions among all stakeholders in ohcs. the proposed framework addresses diabetesrelated needs and challenges including; informational, social, and psychological needs. in this study, we selected online reddit diabetes communities as our data source. the interactions between users are mostly focused on the posts themselves and members will give the post all their attentions. there are numerous diabetes-related topics in this forum, which make it a promising source of users' interactions for this research study. reddit is a social aggregation and public discussion website. in reddit, three popular diabetes communities comprise of more than 60,000 members. in this study, we selected r/diabetes, r/type2diabetes, and r/diabetes_t2 communities. within each community, there are a variety of threads and topics discussed by users. the total number of users in all of these communities was 59,400 in april 2020. from each topic, the tile and the content (e.g., textual information) were extracted without the additional information of the authors. a total of 189 topics were collected from reddit from october 2019 to april 2020. in total 1989 threads were collected for analysis. research argued that participation in diabetes group education program has multiple benefits for patients such as social and emotional support, and sharing experiences (odgers-jewell et al. 2017) . the queensland university of technology (qut) offers a partnership face-to-face dgep to patients who are newly diagnosed or living with the type-2 diabetes long term. over the course of program, the qut dgep aims to provide a quality lifestyle intervention empowering type-2 diabetic patients to better manage their symptoms. the dgep runs for 10 weeks and includes various types of activities such as; initial assessment, weekly one-hour personalized exercise session, one-hour interactive group education regarding diabetes-related topics (e.g., diet, mindfulness, foot care, living with a chronic condition, etc.), and a final assessment at the end of the program. the outcomes of this award-winning program are promising and all patients involved no longer needing to stay on the long waiting list of the hospitals. one of the most important objectives of the dgep is to keep patients connected whilst outside the program. we, therefore, aim to extend the value of the face-to-face dgep by identifying the potential practices on the online diabetes communities, proposing a diabetes ohc framework for keeping patients connected to the program after discharge from the program. aghdam & watson 2020, wellington towards empowering diabetic patients we collected data from the three popular reddit diabetes online communities (r/diabetes, r/type2diabetes, and r/diabetes_t2). reddit is a popular forum for diabetes (duggan and smith 2013) . there are numerous health-related topics on this website, which make it a promising source of users' interactions for this research study. in addition, reddit allows researchers to mine its data. hence, we used the python reddit application programming interface (api) wrapper (praw) to collect the data. praw is a python package that allows researchers to access, parse topics and subreddit, and extract the associated reply threads. as inclusion criteria for selecting posts and threads, we selected type-2 diabetes-related topics with more than 10 replies on each topic to obtain enough information. the interactions between users are mostly focused on the posts themselves and members will give the post all their attention. demographic information about the participants was anonymized to guarantee the confidentiality and privacy of participants' data. in every stage of this research study, we followed the code of ethics for researchers of the queensland university of technology (qut). the approval number is 1900001024. in this study, we conducted an inductive thematic analysis to identify emergent themes from the data. the six steps of thematic analysis provided by (clarke et al. 2015) , guided us to identify the salient themes. following the six steps of the thematic analysis and with the assistance of the nvivo 12 qualitative analysis software, we manually generated an initial list of codes. during the first step, we performed an initial analysis of the relevant topics and threads and recorded our notes via memo and annotation features of nvivo 12. in the second step, we inductively generated 106 nodes. in the third step, we combined codes revealing three overarching themes and nine subthemes. in the fourth step, which was reviewing and refining the themes, we reviewed all themes and subthemes to make sure that they followed a coherence pattern. during this phase, two themes were integrated because of their common content. in the fifth step, we concisely named the identified themes to reflect the story behind each theme and reflect what the themes are about. hence, we named themes that address the research questions. finally, in the sixth step, findings were synthesised to provide a concise and coherent report. in terms of testing the trustworthiness of the findings, we employed percent agreement as our method of inter-coder reliability checking. two scholars, experienced in qualitative research and thematic analysis, checked different parts from creating initial codes to naming the themes. each of them independently analysed the entire data and during the first meeting, the per cent agreement was 75% and after the second meeting, discussing the essence of the themes, a consensus was achieved and the overall results were 100%, making us confident about the reliability of our findings. after performing the thematic analysis, our analysis resulted in three emergent themes from the data. themes include (1) exchange lifestyle-related advice, (2) experience of commonality, and (3) brainstorm potential solutions for daily challenges. table 1 , summarises the thematic analysis outcomes. as evidenced in table 1 , patient participation in diabetes online communities leads to the co-creation of value. for instance, in theme 1, patients shared resources such as articles, and videos with peers. another key finding is to improve patients' psychological wellbeing by participating in online activities such as story sharing and encourage other members of the community in selfmonitoring. ohcs provide an opportunity for users to enhance their knowledge about symptoms, share their experience and advice. information sharing by peers, experience and advice sharing, life-style related advice sharing, and sharing daily-basis activities are the most common activities identified by researchers in this study through thematically analysing the content of threads in the reddit diabetes online communities. these types of giving and seeking (exchanging) advice are illustrative examples of value co-creation behaviours. in the value co-creation process, stakeholders such as organizations, patients or caregivers share, integrate and renew each other's resources ). our analysis shows that diabetic users mostly shared their experience, stories, and online resources (e.g., research articles, youtube videos, and websites' urls). resource exchange is a mutual action taken by stakeholders in ohcs to access, share, and integrate resources (beirão et al. 2017) . in this regard, ohcs can facilitate resource exchange among stakeholder. for instance, members of the diabetes communities shared their up-to-date information and experience about using wearable devices (e.g., continues glucose monitors (cgm), dexcom and sport watches) for self-monitoring their health condition and reduce the burden of living with diabetes and improve quality of life. the experience of commonality in ohcs provides opportunities for members to feel that they are not alone. hence, the experience of commonality is associated with positive mental health, improving emotional wellbeing members of the diabetes communities perceived these online platforms as great places to tackle the feeling of loneliness and isolation. especially in the current situation of the global outbreak of covid-19, these online communities are ideal places to tackle psychological distress and depression. at this particular point in time, diabetic patients need to strengthen their sense of community by connecting and supporting each other in the ohcs. because of the nature of ohcs, aghdam & watson 2020, wellington towards empowering diabetic patients which provides access to information and coordinated social interactions, the members of these communities benefit an alternative solution and needs such as improving their wellbeing (zhao et al. 2015) . emotional support directly impacts on the ability to self-manage diabetes and equally selfmanagement of diabetes influences emotional wellbeing (schiøtz et al. 2012) . sharing the same situation and stories with other members is another aspect of emotional support. sharing the same stories creates a shared sense of meaning and community for users. in the reddit diabetes communities, a large number of users encourage peers in their self-management of diabetes. patients also reported that sharing monitoring data such as blood glucose and weight makes them feel empowered and motivated. members of these communities' support each other in coping with social and emotional barriers, staying motivated to reach their goals, and encourage better self-care habits without fear of judgement or stigma. improving the emotional wellbeing of diabetes leads to better self-care, overcoming psychological barriers, and ultimately, a better quality of life. ohcs are ideal places for brainstorming solutions by members. we identified brainstorming of potential solutions to address daily challenges as another co-creation behaviour occurred in diabetes online communities. virtual brainstorming is one of the most significant benefits of ohcs for diabetic patients. it provides an opportunity for community members to contribute new ideas to address diabetic daily challenges such as carrying medical equipment, diabetic's workplace problems, injection, and sleep problems. this was identified in many threads posted by the members of the communities. hence, ohcs are ideal places to brainstorm potential solutions to address these issues. as it can be viewed in table 1 , reddit patient suggests a solution to another patient, who is struggling with carrying diabetes bag in public and private business areas. these types of solutions are another example of value co-creation behaviour within diabetes online communities. participating of community members in brainstorming activities, make them feel that their contributions are valuable and their ideas will help peers to tackle some daily challenges. because of the high number of demands for dgep, patients need to be in a waiting list before joining the program. while they are in a waiting list, they can communicate with discharged patients and use their experience. the resource exchange help patients reduce their stress and better prepare for the program. during the program patients, share their experiences and health-related stories with peers, encouraging each other to reach their health-related goals. during this phase, ohc can play an important role as an online interactive platform to facilitate patient-to-patient and patient-to-hcp interaction. after discharge from the program, patients still need to stick to their plans and selfmanage their diabetes. ohcs provide opportunities for them to keep connected to the program, interact with hcps and share their experience of the program with patients, who are in the "prior-tojoining" phase. figure 1 , demonstrates the proposed framework for diabetes online communities. aghdam & watson 2020, wellington towards empowering diabetic patients in terms of the validity and utility of the proposed framework, we conducted expert interviews. a qualitative assessment of the framework flexibility was carried out through interviews with healthcare professionals and the diabetes program coordinator at the qut clinic. two health experts, who are directly involved and organised the dgep, and have more than ten years of experience in the healthcare domain initially evaluated the framework and provided their feedback and suggestions. ohcs are proper educational platforms that lead to better health outcomes and members can learn more from others on how to better manage their health conditions (chen et al. 2019 ). information that shared by patients in ohcs benefits other patients by learning from peers, improving their self-management of disease, and ultimately, improving their health (yan and tan 2014) . the proposed framework focused on patients as active agents in the process of online value co-creation. patients are pivotal stakeholders in our framework that can co-create value by resource exchange and social support. in our framework, diabetic patients participate in different forms of value co-creation through informational, social, and emotional support. ohcs empower patients to actively engage in co-creation activities 24/7 especially in times of fear, isolation, and uncertainty. this research study has been conducted during the global pandemic of the covid-19. during this pandemic and isolation time, patients increasingly participate in diabetes online communities to gain and offer emotional support. these easy-access and 24/7 online platforms help patients to tackle psychological issues such as depression, anxiety, and loneliness because diabetic patients have a twofold greater risk of depression (schram et al. 2009 ). shared stories and experiences in ohcs make patients feel that they are not alone, strengthening their sense of community by connecting and supporting each other. digital health platforms such as diabetes online communities have the potential to increase easy access to diabetes self-management interventions and techniques in the lower cost (rosal et al. 2014) . furthermore, participating in diabetes group-based education program provides opportunities for patients to meet and discuss with other members of the communities, obtaining social and emotional support (steinsbekk et al. 2012) . in doing so, in recent years, the queensland university of technology (qut) offer a partnership program to patients who are newly diagnosed or living with the condition long term. this program aims to provide a quality lifestyle intervention and empowering type-2 diabetic patients to better manage their symptoms. as type-2 diabetes is a self-managed disease, one of the main aims of the program is to keep patients connected to the program after discharge. we australasian conference on information systems aghdam & watson 2020, wellington towards empowering diabetic patients adopted customer-dominant logic (cdl) as a way to explore overlaps between our findings and the dgep. cdl is focused on activities and experiences of the customer at three different stages: preservice, service, and post-service (heinonen and strandvik 2015) . it is used as a way to extend the customers' perceptions of the offering and to extend market interactions (heinonen and strandvik 2015) . following cdl, we divided the diabetic patient journey into three phases including; (1) prior to joining the program, (2) during the program, and (3) after discharge from the program. in each phase, we identified value co-creation behaviours such as; resource sharing, story and advice sharing, and social and emotional support. theoretically, we extended the target body of the knowledge in the healthcare service delivery through enhancing the empowerment theory in which, patients are the central facet and healthcare professionals and healthcare organisations are facilitators of the value cocreation process (funnell and anderson 2004) . research studies have overlooked the nuances relationship between empowerment theory, value co-creation, and the role of ohcs as facilitators for this process. this study provides an opportunity for leveraging peer-to-peer support within digital health platforms such as ohcs to empower patients in their self-management of diabetes. practically, our findings further provide recommendations to the healthcare industry on how to effectively contribute to the online intervention by shifting from traditional dyadic interaction between healthcare professionals and the patient to online co-creation among all stakeholders. we believe that healthcare providers can potentially use our theoretical and empirical findings to extend the value of the face-toface diabetes group-based education programs by keep patients connected to the program 24/7 regardless of their geographical distance with lower cost. our study is not without limitations, yet these limitations provide interesting avenues for future research. our data were gathered from reddit diabetes online communities. we selected three popular diabetes communities on the reddit to analyse the contents and interactions among members. we might overlook some small communities related to type-2 diabetes. furthermore, we only used reddit as our data collection source. future studies can focus on more diabetes online communities, aiming that how can a fully functional assistive artefact be designed for diabetic patients, using the design science research guideline (miah 2008; miah et al. 2019) . although the face-to-face diabetes education program held in queensland, australia, it can be generalised to any other organisational or country context (for example, in decision support implementation (ali, miah and khan, 2018) ensuring empowering end users). our future study will extend the current framework by conducting interviews with the members of the communities to identifying their current level of engagement with ohc, identify benefits and challenges of using these platforms, and investigate their online value co-creation behaviour. therefore, there are some areas required for further research. another future avenue is to investigate the perspective in which healthcare organisations indirectly participate in online value cocreation. experimental design studies of ohcs to explore the behavioural and psychological aspects of social support could also be useful. in this research study, we sought to extend the current understanding of the potential of diabetes online communities in empowering self-management for diabetic patients. as such, the main aim of this study was to investigate the potential practices of online diabetes communities to empower selfmanagement of diabetic patients in their health journey. findings show that patients in diabetes online communities share information, experiences, stories, and potential solutions. they actively participate in online activities regarding offering and receiving support from peers. the vast majority of the shared contents on diabetes online communities include lifestyle-related advice such as diet, exercise and using wearable technologies to better monitor and care of diabetes. members of diabetes online communities contend that these online forums are ideal platforms to obtain social and emotional support from peers. our findings, which investigated the connection between diabetes online communities' practices and outcomes and the real-world dgep case can further assist healthcare organisations to effectively contribute to the online intervention and extend their communication channel from a traditional power balance between hco and patients to interactive platform that enables all stakeholders to actively engage in value co-creation activities. as discussed, type-2 diabetes is a chronic disease that needs ongoing self-care and self-manage. ohcs provide opportunities for them to encourage each other in regards to sticking to their self-monitoring and selfmanagement. this is especially true when they discharge from the dgep and have no access to faceto-face interactions. the 1st annual crossing the quality chasm summit: a focus on communities improving the theoretical understanding toward patient-driven health care innovation through 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intentions in online health communities empowerment theory this is an open-access article licensed under a creative commons attribution-noncommercial 3.0 new zealand, which permits non-commercial use, distribution, and reproduction in any medium key: cord-002929-oqe3gjcs authors: strano, emanuele; viana, matheus p.; sorichetta, alessandro; tatem, andrew j. title: mapping road network communities for guiding disease surveillance and control strategies date: 2018-03-16 journal: sci rep doi: 10.1038/s41598-018-22969-4 sha: doc_id: 2929 cord_uid: oqe3gjcs human mobility is increasing in its volume, speed and reach, leading to the movement and introduction of pathogens through infected travelers. an understanding of how areas are connected, the strength of these connections and how this translates into disease spread is valuable for planning surveillance and designing control and elimination strategies. while analyses have been undertaken to identify and map connectivity in global air, shipping and migration networks, such analyses have yet to be undertaken on the road networks that carry the vast majority of travellers in low and middle income settings. here we present methods for identifying road connectivity communities, as well as mapping bridge areas between communities and key linkage routes. we apply these to africa, and show how many highly-connected communities straddle national borders and when integrating malaria prevalence and population data as an example, the communities change, highlighting regions most strongly connected to areas of high burden. the approaches and results presented provide a flexible tool for supporting the design of disease surveillance and control strategies through mapping areas of high connectivity that form coherent units of intervention and key link routes between communities for targeting surveillance. networks, the regular and planar nature of road networks precludes the formation of clear communities, i.e. roads that cluster together shaping areas that are more connected within their boundaries than with external roads. highly connected regional communities can promote rapid disease spread within them, but can be afforded protection from recolonization by surrounding regions of reduced connectivity, making them potentially useful intervention or surveillance units 6, 26, 27 . for isolated areas, a focused control or elimination program is likely to stand a better chance of success than those highly connected to high-transmission or outbreak regions. for example, reaching a required childhood vaccination coverage target in one district is substantially more likely to result in disease control and elimination success if that district is not strongly connected to neighbouring districts where the target has not been met. the identification of 'bridge' routes between highly connected regions could also be of value in targeting limited resources for surveillance 28 . moreover, progressive elimination of malaria from a region needs to ensure that parasites are not reintroduced into areas that have been successfully cleared, necessitating a planned strategy for phasing that should be informed by connectivity and mobility patterns 26 . here we develop methods for identifying and mapping road connectivity communities in a flexible, hierarchical way. moreover, we map 'bridge' areas of low connectivity between communities and apply these new methods to the african continent. finally, we show how these can be weighted by data on disease prevalence to better understand pathogen connectivity, using p. falciparum malaria as an example. african road network data. data on the african road network (arn) were obtained from gps navigation and cartography as described in a previous study 24 . the dataset maps primary and secondary roads across the continent, and while it does have commercial restrictions, it is a more complete and consistent dataset than alternative open road datasets (e.g. openstreetmap 29 , groads 30 ). visual inspection and comparison between the arn and other spatial road inventories validated the improved accuracy and consistency of arn, however a quantitative validation analysis was not possible due to the lack of consistent ground-truth data at continental scales. figure 1a shows the african road network data used in this analysis. the road network dataset is a commercial restricted product and requests for it can be directly addressed to garmin 31 . plasmodium falciparum malaria prevalence and population maps. to demonstrate how geographically referenced data on disease occurrence or prevalence can be integrated into the approaches outlined, gridded data on plasmodium falciparum malaria prevalence were obtained from the malaria atlas project (http:// www.map.ox.ac.uk/). these represent modelled estimates of the prevalence of p. falciparum parasites in 2015 per 5 × 5 km grid square across africa 32 . additionally, gridded data on estimated population totals per 1 × 1 km grid square across africa in 2015 were obtained from the worldpop program (http://www.worldpop.org/). the population data were aggregated to the same 5 × 5 km gridding as the malaria data, and then multiplied together to obtain estimates of total numbers of p. falciparum infections per 5 × 5 km grid square. detecting communities in the african road network. we modeled the arn as a'primal' road network, where roads are links and road junctions are nodes 33 . spatial road networks have, as any network embedded in two dimensions, physical spatial constraints that impose on them a grid-like structure. in fact, the arn primal network is composed of 300, 306 road segments that account for a total length of 2, 304, 700 km, with an average road length of 7.6 km ± 13.2 km. such large standard deviations, as already observed elsewhere 23, 24, 34 , are due to the long tailed distribution of road lengths, as illustrated in fig. 1c . another property of road network structure is the frequency distribution of the degree of nodes, defined as the number of links connected to each node. most networks in nature and society have a long tail distribution of node degree, implying the existence of hubs (nodes that connect to a large amount of other nodes) 21 , with the majority of nodes connecting to very few others. for road networks, however, the degree distribution strongly peaks around 3, indicating that most of the roads are connected with two other roads. the long tail distribution of the length of road segments, coupled with the peaked degree distribution, indicates the presence of translational invariant grid-like structure, in which road density smoothly varies among regions while their connectivity and structure does not. within such gridlike structures it is very difficult to identify clustered communities, i.e. groups of roads that are more connected within themselves than to other groups. this observation is confirmed by the spatial distribution of betweenness centrality (bc), which measures the amount of time the shortest paths between each couple of nodes pass through a road. the probability distribution of bc is long tailed (fig. 1d) , while its spatial distribution spreads across the entire network, with a structural backbone form, as shown in fig. 1b. again, under such conditions and because of the absence of bottlenecks, any strategy to detect communities that employs pruning on bc values 35 , will be minimally effective. to detect communities in road networks we follow the observation that human displacement in urban networks is guided by straight lines 36 . therefore, geometry can be used to detect communities of roads by assuming that people tend to move more along streets than between between streets. we developed a community detection pipeline that converts a primal road network, where roads are links and roads junction are nodes 33 , to a dual network representation, where link are nodes and street junction link between nodes 37 , by mean of straightness and contiguity of roads. it is important to note here that the units of analysis are road segments, which here are typically short and straight between intersections, making the straightness assumption valid. community detection in the dual network is then performed using a modularity optimization algorithm 38 . the communities found in the dual network are then mapped back to the original primal road network. these communities encode information about the geometry of road pattern but can also incorporate weights associated with a particular disease to guide the process of community detection. nodes in the dual network represent lines in the primal network. the conversion from primal to dual is done by using a modified version of the algorithm known as continuity negotiation 37 . in brief, we assume that a pair of adjacent edges belongs to the same street if the angle θ between these edges is smaller than θ c = 30°. we also assume that the angle between two adjacent edges (i, j) and (j, p) is given by the dot product cos (θ) = r i, j r j,p /r i, j r j,p , where r i, j = r j r i . under these assumptions, the angle between two edges belonging to a perfect straight line is zero, while it assumes a value of 90° for perpendicular edges. our algorithm starts searching for the edge that generates the longest road in the primal space, as can be seen in fig. 2a . then, a node is created in the dual space and assigned to this road. next, we search for the edge that generates the second longest road, and a new node is created in the dual space and assigned to this road. if there is at least one interception between the new road and the previous one, we connect the respective nodes in the dual space. the algorithm continues until all the edges in the primal space are assigned to a node in the dual space, as shown in fig. 2b . note that the conversion from primal to the dual road network has been used extensively to estimate human perception and movement along road networks (space syntax, see 36 ) , which also supports our use of road geometry to detect communities. despite the regular structure of the network in the primal space, the topology of these networks in the dual space is very rich. for instance the degree distribution in dual space follows the power-law p(k) k −γ . this property has been previously identified in urban networks 33 and it is strongly related to the long tailed distribution of road lengths in these networks (see fig. 1c ). since most of the roads are short, most of the nodes in dual space will have a small number of connections. on the other hand, there are a few long roads (fig. 2a ) that originate at hubs in the dual space (fig. 2b ). our approach for detecting communities in road networks consists then in performing classical community detection in the dual representation ( fig. 2c) and then bringing the result back to the primal representation, as shown in fig. 2d . the algorithm used to detect the communities is the modularity-based algorithm by clauset and newman 35 . the hierarchical mapping of communities on the african road network, with outputs for 10, 20, 30 and 40 sets of communities, is shown in fig. 3 . the maps highlight how connectivity rarely aligns with national borders, with the areas most strongly connected through dense road networks typically straddling two or more countries. the hierarchical nature of the approach is illustrated through the breakdown of the 10 large regions in fig. 3a into further sub-regions in b, c and d, emphasizing the main structural divides within each region in mapped in 3a. some large regions appear consistently in each map, for example, a single community spans the entire north african coast, extending south into the sahara. south africa appears as wholly contained within a single community, while the horn of africa containing somalia and much of ethiopia and kenya in consistently mapped as one community. the four maps shown are example outputs, but any number of communities can be identified. the clustering that maximises modularity produces 104 communities, and these are mapped in fig. 4 . even with division into 104 communities, the north africa region remains as a single community, strongly separated from sub-saharan africa by large bridge regions. south africa also remains as almost wholly within its own community, with somalia and namibia showing similar patterns. the countries with the largest numbers of communities tend to be those with the least dense infrastructure equating to poor connectivity, such as drc and angola, though west africa also shows many distinct clusters, especially within nigeria. apart from the sahara, the largest bridge regions of poor connectivity are located across the central belt of sub-saharan africa, where population densities are low and transport infrastructure is both sparse and often poor. the communities mapped in figs 3 and 4 align in many cases with recorded population and pathogen movements. for example, the broad southern and eastern community divides match well those seen in hiv-1 subtype analyses 12 and community detection analyses based on migration data 27 . at more regional scales, there also exist similarities with prior analyses based on human and pathogen movement patterns. for example, the western, coastal and northern communities within kenya in fig. 4b , identified previously through mobile phone and census derived movement data 39, 40 . further, guinea, liberia and sierra leone typically remain mostly within a single community in fig. 3 , with some divides evident in fig. 4c . this shows some strong similarities with the spread of ebola virus through genome analysis 15 , particularly the multiple links between rural guinea and sierra leone, though fig. 4c highlights a divide between the regions containing conakry and freetown when africa is broken into the 104 communities. figure 3 highlights the connections between kinshasa in western drc and angola, with the recent yellow fever outbreak spreading within the communities mapped. figure 4d shows the'best' communities map for an area of southern africa, and the strong cross-border links between swaziland, southern mozambique and western south africa are mapped within a single community, as well as wider links highlighted in fig. 3 , matching the travel patterns found from swaziland malaria surveillance data 41 . integrating p. falciparum malaria prevalence and population data with road networks for weighted community detection. the previous section outlined methods for community detection on unweighted road networks. to integrate disease occurrence, prevalence or incidence data for the identification of areas of likely elevated movement of infections or for guiding the identification of operational control units, an adaptation to weighted networks is required. we demonstrate this through the integration of the data on estimated numbers of p. falciparum infections per 5 × 5 km grid square into the community detection pipeline. the final pipeline for community detection calculated a trade-off between form and function of roads in order to obtain a network partition. the form is related to the topology of the road network and is taken into account during the primal-dual conversion. the topological component guarantees that only neighbor and well connected locations could belong to the same community. the functional part, on the other hand, is calculated by the combination of estimated p. falciparum malaria prevalence multiplied by population to obtain estimated numbers of infections, as outlined above. the two factors were combined to form a weight to each edge of our primal network. the weight w i, j of edge (i, j) is defined as where m(r) is the p. falciparum malaria prevalence and p(r) is the population count, both at coordinate r. these values are obtained directly from the data. when the primal representation is converted into its dual version, the weights of primal edges, given by eq. 1, are converted into weights of dual nodes, which are defined as where i represents the i th dual node and ω i represents the set of all the primal edges that were combined together to form the dual node i (see fig. 2a,b) . finally, weights for the dual edges are created from the weights of dual nodes, by simply assuming the dual network weighted by values of λ i,¯j was used as input for a weighted community detection algorithm. ultimately, when the communities detected in the dual space are translated back to primal space, we have that neighbor locations with similar values of estimated p. falciparum infections belong to the same communities. for the example of p. falciparum malaria used here, the max function was used, representing maximum numbers of infections on each road segment in 2015. this was chosen to identify connectivity to the highest burden areas. areas with large numbers of infections are often 'sources' , with infected populations moving back and forward from them spreading parasites elsewhere 6, 42 . therefore, mapping which regions are most strongly connected to them is of value. alternative metrics can be used however, depending on the aims of the analyses. the integration of p. falciparum malaria prevalence and population (fig. 5a ) through weighting road links by the maximum values across them produces a different pattern of communities (fig. 5b) to those based solely on network structure (fig. 3) . the mapping of 20 communities is shown here, as it identifies key regions of known malaria connectivity, as outlined below. the mapping shows areas of key interest in malaria elimination efforts connected across national borders, such as much of namibia linked to southern angola 43 , but the zambezi region of namibia more strongly linked to the community encompassing neighbouring zambia, zimbabwe and botswana 44 . in namibia, malaria movement communities identified through the integration of mobile phone-based movement data and case-based risk mapping 26 show correspondence in mapping a northeast community. moreover, swaziland is shown as being central to a community covering, southern mozambique and the malaria endemic regions of south africa, matching closely the origin locations of the majority of internationally imported cases to swaziland and south africa 41, 45, 46 . the movements of people and malaria between the highlands and southern and western regions of uganda, and into rwanda 47 , also aligns with the community patterns shown in fig. 5b . finally, though quantifying different factors, the analyses show a similar east-west split to that found in analyses of malaria drug resistance mutations 6, 48 and malaria movement community mapping 27 . the emergence of new disease epidemics is becoming a regular occurrence, and drug and insecticide resistance are continuing to spread around the world. as global, regional and local efforts to eliminate a range of infectious diseases continue and are initiated, an improved understanding of how regions are connected through human transport can therefore be valuable. previous studies have shown how clusters of connectivity exist within the global air transport network 49, 50 and shipping traffic network 50 , but these represent primarily the sources of occasional long-distance disease or vector introductions 1, 8 , rather than the mode of transport that the majority of the population uses regularly. the approaches presented here focused on road networks provide a tool for supporting the design of disease and resistance surveillance and control strategies through mapping (i) areas of high connectivity where pathogen circulation is likely to be high, forming coherent units of intervention; (ii) areas of low connectivity between communities that form likely natural borders of lower pathogen exchange; (iii) key link routes between communities for targetting surveillance efforts. the outputs of the analyses presented here highlight how highly connected areas consistently span national borders. with infectious disease control, surveillance, funding and strategies principally implemented country by country, this emphasises a mismatch in scales and the need for cross-border collaboration. such collaborations are being increasingly seen, for example with countries focused on malaria elimination (e.g. 51, 52 ), but the outputs here show that the most efficient disease elimination strategies may need to reconsider units of intervention, moving beyond being constrained by national borders. results from the analysis of pathogen movements elsewhere confirm these international connections (e.g. 6, 12, 41, 48 , building up additional evidence on how pathogen circulation can be substantially more prevalent in some regions than others. the approaches developed here provide a complement to other approaches for defining and mapping regional disease connectivity and mobility 9 . previously, census-based migration data has been used to map blocks of countries of high and low connectivity 27 , but these analyses are restricted to national-scales and cover only longer-term human mobility. efforts are being made to extend these to subnational scales 53, 54 , but they remain limited to large administrative unit scales and the same long timescales. mobile phone call detail records (cdrs) have also been used to estimate and map pathogen connectivity 26, 40 , but the nature of the data mean that they do not include cross-border movements, so remain limited to national-level studies. an increasing number of studies are uncovering patterns in human and pathogen movements and connectivity through travel history questionnaires (e.g. 41, 47, 55, 56 ), resulting in valuable information, but typically limited to small areas and short time periods. there exist a number of limitations to the methods and outputs presented here that future work will aim to address. firstly, the hierarchies of road types are not currently taken into account in the network analyses, meaning that a major highway and small local roads contribute equally to community detection and epidemic spreading. the lack of reliable data on road typologies, and inconsistencies in classifications between countries, makes this challenging to incorporate however. moreover, the relative importance of a major road versus secondary, tertiary and tracks is exceptionally difficult to quantify within a country, let alone between countries and across africa. finally, data on seasonal variations in road access does not exist consistently across the continent. our focus has therefore been on connectivity, in terms of how well regions are connected based on existing road networks, irrespective of the ease of travel. a broader point that deserves future research is that while intuition suggests a correspondence in most places, connectivity may not always translate into human or pathogen movement. future directions for the work presented here include quantitative comparison and integration with other connectivity data, the integration of different pathogen weightings, and the extension to other regions of the world. qualitative comparisons outlined above show some good correspondence with analyses of alternative sources of connectivity and disease data. a future step will be to compare these different connections and communities quantitatively to examine the weight of evidence for delineating areas of strong and weak connectivity. this could potentially follow similar studies looking at community structure on weighted networks, such as in the us based on commuting data 57 , or uk and belgium from mobile network data 58, 59 . here, p. falciparum malaria was used to provide an example of the potential for weighting analyses by pathogen occurrence, prevalence, incidence or transmission suitability. moreover, future work will examine the integration of alternative pathogen weightings. the maximum difference method was used here to pick out regions well connected to areas high p. falciparum burden, but the potential exists to use different weighting methods depending on requirements, strategic needs, and the nature of the pathogen being studied. despite the rapid growth of air travel, shipping and rail in many parts of the world, roads continue to be the dominant route on which humans move on sub-national, national and regional scales. they form a powerful force in shaping the development of areas, facilitating trade and economic growth, but also bringing with them the exchange of pathogens. results here show that their connectivity is not equal however, with strong clusters of high connectivity separated by bridge regions of low network density. these structures can have a significant impact on how pathogens spread, and by mapping them, a valuable evidence base to guide disease surveillance as well as control and elimination planning can be built. results were produced through four main phases. phase 1: road network cleaning and weighted adjacency list production: the road cleaning operation aimed to produce a road network from the georeferenced vectorial network of roads infrastructure. this phase was conducted using esri arcmap 10.4 (http://desktop.arcgis.com/en/ arcmap/) through the use of the topological cleaning tool. the tool integrates contiguous roads, removes very short links and removes overlapping road segments. road junctions were created using the polyline to node conversion tool, while road-link association was computed using the spatial join tool. malaria prevalence values were assigned to each road using the spatial join tool. the adjacency matrix output, containing also the coordinates for each road junctions, was extracted in form of text file. phase 2: conversion from the primal to the dual network: the primal network created in phase 1 was then used as input for a continuity negotiation-like algorithm. the goal of this algorithm was to translate the primal network into its dual representation (see fig. 2a,b) . the implementation of the negotiation-like algorithm used the igraph library in c++ (http://igraph.org/c/) on an octa-core imac. the conversion took around 20 hours for a primal network with ~200 k nodes running. the algorithm works by first identifying roads composed of many contiguous edges in the primal space. two primal-edges are assumed to be contiguous if the angle between them is not greater than 30° degrees. because the dual representation generated by the algorithm strongly depends on the starting edge, we started by looking for the edge that produces the longest road. as soon as this edge was found, a dual-node was created to represent that road. next we proceeded to look for the edge that produced the second longest road and create a dual-node for that road. we continued this process until every primal-edge had been assigned to a road. finally, dual-nodes were connected to each other if their primal counterparts (roads) crossed each other in the primal space. phase 3: community detection: we used a traditional modularity optimization-based algorithm to identify communities in the dual representation of the road network. the modularity metrics were computed in r using the igraph library (http://igraph.org/r/). to incorporate the prevalence of malaria, we used the malaria prevalence values as edge weights for community detection. phase 4: mapping communities. detected communities were mapped back to the primal road network with the use of the spatial join tool in arcmap. all maps were produced in arcmap. global transport networks and infectious disease spread severe acute respiratory syndrome h5n1 influenza-continuing evolution and spread geographic dependence, surveillance, and origins of the 2009 influenza a (h1n1) virus the global tuberculosis situation and the inexorable rise of drug-resistant disease the transit phase of migration: circulation of malaria and its 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and community structure in networks the use of census migration data to approximate human movement patterns across temporal scales quantifying the impact of human mobility on malaria travel patterns and demographic characteristics of malaria cases in swaziland human movement data for malaria control and elimination strategic planning malaria risk in young male travellers but local transmission persists: a case-control study in low transmission namibia the path towards elimination reviewing south africa's malaria elimination strategy (2012-2018): progress, challenges and priorities targeting imported malaria through social networks: a potential strategy for malaria elimination in swaziland association between recent internal travel and malaria in ugandan highland and highland fringe areas multiple origins and regional dispersal of resistant dhps in african plasmodium falciparum malaria the worldwide air transportation network: anomalous centrality, community structure, and cities' global roles the complex network of global cargo ship movements asian pacific malaria elimination network mapping internal connectivity through human migration in malaria endemic countries census-derived migration data as a tool for informing malaria elimination policy key traveller groups of relevance to spatial malaria transmission: a survey of movement patterns in four subsaharan african countries infection importation: a key challenge to malaria elimination on bioko island, equatorial guinea an economic geography of the united states: from commutes to megaregions redrawing the map of great britain from a network of human interactions uncovering space-independent communities in spatial networks e.s., m.p.v. and a.j.t. conceived and designed the analyses. e.s. and m.p.v. designed the road network community mapping methods and undertook the analyses. all authors contributed to writing and reviewing the manuscript. competing interests: the authors declare no competing interests.publisher's note: springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.open access this article is licensed under a creative commons attribution 4.0 international license, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the creative commons license, and indicate if changes were made. the images or other third party material in this article are included in the article's creative commons license, unless indicated otherwise in a credit line to the material. if material is not included in the article's creative commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. to view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/. key: cord-252526-4vsfl62z authors: laborde, yvens; manayan, olivia title: community outreach panel explores and addresses higher rates of covid-19–related deaths in the african american population date: 2020 journal: ochsner j doi: 10.31486/toj.20.0063 sha: doc_id: 252526 cord_uid: 4vsfl62z nan in louisiana, african americans are disproportionately affected by poor health outcomes compared to whites with similar health conditions. 1 the novel coronavirus has proven to be no exception, with the african american population accounting for 70.5% of covid-19-related deaths, despite only comprising 32.2% of the state's population. 2 this disparity is thought to be multifactorial, with many of the factors that contribute to health inequity in the african american population also contributing to the morbidity and mortality rates seen in this same population with the novel coronavirus. these factors, which include higher rates of poverty and housing density; lower rates of stable, salaried jobs that permit work-from-home arrangements; and the burden of preexisting, chronic medical conditions, effectively equate to an inability for many members of this community to practice social distancing. to gain further insight into how healthcare professionals can address these factors, drs yvens laborde and olivia manayan, in collaboration with the regular baptist church of new orleans, organized a question and answer panel ( figure) with the aims of (1) providing accurate, up-to-date, evidence-based information about covid-19 to the public in a way that was approachable and accessible, (2) answering questions posed by members of the community, and (3) gaining a better understanding of the root causes of inequities in the healthcare system. the panel was administered through the zoom meeting platform and lasted approximately 60 minutes, with 36 members of the community participating. among the themes discussed were safe social distancing practices, current guidelines for treatment and testing of covid-19, tackling social isolation in the home and intensive care unit setting, and guidelines for quarantining at home. participants expressed interest in participating in clinical trials for novel treatments for the coronavirus and for at-home monitoring of symptoms such as blood pressure and blood oxygen saturation, particularly those who had preexisting comorbidities such as hypertension, diabetes, obesity, and chronic obstructive pulmonary disease. participants sought clarification about articles they had encountered in the media and asked about the use of extracorporeal membrane oxygenation and hyperbaric oxygen chambers as treatments and the use of humidifiers combined with hydrogen peroxide as air sanitation devices. participants expressed the desire for easier and greater access to community testing. one important insight was that not all individuals have access to a vehicle; therefore, the participants expressed a strong desire for the availability of walk-up testing. another challenge is multigenerational households and the need for social support to obtain alternate temporary housing options for covid-19-positive patients being cared for at home. the participants also discussed the heavy financial and mental burdens that the stay-at-home orders were having on them individually and on their communities. volume 20, number 2, summer 2020 gaining first-hand perspectives from individuals at higher risk of mortality from the novel coronavirus is necessary to understand the inequities in healthcare and to form effective strategies to combat these inequities. additional community engagement and outreach activities are needed to further our understanding and to improve the accessibility of healthcare and information for high-risk communities. we hope to engage in more community-based interventions that incorporate the feedback provided during the first session, such as increased at-home monitoring using smart devices that digitally share measurements (eg, oxygen saturation monitors and thermometers). further, all such community-based outreach activities should take into account the importance of meeting context and setting, particularly focusing on the increased effectiveness of integrating outreach into preexisting community groups such as churches or vocational groups. innovative methods of community outreach that are culturally sensitive can provide a powerful platform to engage, empower, and improve health outcomes for african americans and other at-risk communities. as martin luther king famously stated, "of all the forms of inequality, injustice in health is the most shocking and the most inhuman because it often results in physical death." louisiana maternal mortality review report 2011-2016. louisiana department of health covid-19 and african americans ©2020 by the author(s) this article is an open access article distributed under the terms and conditions of the creative commons attribution (cc by) license (creativecommons.org/licenses/by/4.0/legalcode) that permits unrestricted use, distribution, and reproduction in any medium key: cord-332625-3rvis2gy authors: modell, stephen m.; kardia, sharon l. r. title: religion as a health promoter during the 2019/2020 covid outbreak: view from detroit date: 2020-06-16 journal: j relig health doi: 10.1007/s10943-020-01052-1 sha: doc_id: 332625 cord_uid: 3rvis2gy the 2019/2020 covid outbreak has surfaced as a global pandemic. the news has carried stories of the heroic efforts of medical and other health practitioners, with public health officials charting the course of spread. in an urban center like detroit, the generosity of everyday citizens and church organizations has also played an important role. this inspection of the pandemic from the view of detroit will examine the epidemiology of the coronavirus, translation of professional practice into people’s awareness of the chronic disease risk factors which are prevalent in detroit, moral and ethical views on the distribution of resources, and three major ways that religious faith has helped to sustain people’s health and welfare in the midst of the broad social challenges posed by this novel coronavirus. a career day presentation at detroit country day school on a typical day in the life of a public health academician turned into a consoling letter for at-home students on the importance of prevention and the essential value of public health among the other health-related professions. a nephew returning in a rush to chicago from israel caught the coronavirus and then thankfully recovered within 2 weeks, possibly due to his age, having recently graduated from college. the centers for disease control and prevention (cdc) released its 13-page interim guidance for administrators and leaders of community-and faith-based organizations to plan, prepare, and respond to coronavirus disease 2019 which contained diplomatically worded, now understated instructions to "monitor and plan for absenteeism" (cdc 2020, p. 5) . in truth, detroit is known for its myriad overly active churches, mosques, and synagogues, all of which were ironically desolate on days commemorating the rebirth of a religious figurehead, new meaning and prophetic promise, and the freeing of a people from bondage. in this inspection of the covid-19 pandemic, the health status of the city of detroit will be assessed, considering chronic disease contributors and awareness of those contributors. resources are in short supply; the ethics of provider and interventional availability will be considered. community health needs assessments, which in detroit receive input through the efforts of religious community-based organizations, offer one measure of local health and health policies. religious faiths have been sustaining the health and well-being of city residents in connection with the pandemic along three broad fronts that will be tied together in the latter portions of this view from detroit. at our institution 45 min from detroit, as of april 23 the university of michigan medical center reports 175 covid-19 inpatients, 167 of whom have tested positive (michigan medicine 2020) . in the heart of detroit, henry ford hospital reports 185 inpatients testing positive and 3043 outpatients with positive disease status . about half the cases in michigan are nested in wayne county, of which detroit is the largest city. the cdc and world health organization place at higher risk adults over 60 and those with chronic medical conditions (hypertension, obesity, diabetes, lung disease, heart disease, and those with compromised immune systems) (garg et al. 2020, p. 462) . the cdc office of public health genomics has noted the potential for specific biological factors (the ultimate goal of diagnostic and therapeutic targeting)-ace2 genetic variants, interleukin-6, hla antigens, and particular blood groups-to be risk factors in covid-19 severity and outcome (khoury et al. 2020) . risk factors for viral transmission and severity should include elucidation of both viral and human genomes and their interaction. however, it also notes the important role environmental, social and economic factors, and compiled "big data" play in this kind of outbreak. dr. teena chopra, an infectious disease professor at wayne state university who is working with coronavirus patients at detroit medical center, underscores this point: "the high rates of social disadvantage and higher comorbidities make the city of detroit more vulnerable to . so these are the reasons why detroit is, as far as predictions are concerned, showing the steeper curve, and steeper than even new york" (guardian 2020) . about a third of the people in detroit live in poverty. states dr. abdul el-sayed, who resurrected the detroit health department from the city's municipal bankruptcy in 2013, "i think if you're working an $11-an-hour job that has no paid sick leave and no protection guarantee, that being forced to go out and do your job or lose it in the middle of a pandemic is going to increase your probability of either contracting an infectious disease or transmitting it" (bach 2020) . among the covid-19 biological risk factors, el-sayed observes that 4 out of 10 detroit adults are obese, which increases their chances for heart disease and diabetes, and the rate of asthma hospitalizations is more than three times the state average (nather 2016 the detroit health department is quite active in the midst of the pandemic, providing free covid-19 testing; charting the virus' spread in the city by zip code; maintaining a readily viewable covid-19 data dashboard (e.g., showing drive thru testing results and total number of detroit shelters that are screening); and maintaining a covid-19 call center. these are ambitious activities considering that when el-sayed took over, the department was down to 5 people (now it has more than 50). dr. el-sayed's efforts are not singular, though. the m.d., m.p.h. down the hallway from the authors is a busy member of the governor's michigan coronavirus task force on racial disparities. immediately across from the authors is a flu investigational research group that has been pulling in and compiling influenza, respiratory syncytial virus, and covid-19 case data from three hospital systems, including henry ford hospital in detroit, on a daily basis. heroics take place both in the emergency room and the public health setting. shortly after the 2003 severe acute respiratory syndrome (coronavirus sars-cov) pandemic, a toronto physician who had three previous generation family members die in the spanish flu pandemic of 1918 wrote about the ethical clashes a healthcare provider experiences under such circumstances (sawa 2007, pp. 303-306) . two major dilemmas, and decision points, occur. the provider must choose: (1) between the good of an individual person (say, him-or herself or a dear patient) and the well-being of the public and (2) between helping those closest to him or her (family members) and public duty. sawa concluded, "the solution is not simply to move from a conscience-based ethics to a utilitarian-based approach. there will be conflicts in such circumstances between the public health providers and individuals. at times there may be no obvious or 'correct' answers to the dilemmas which emerge. … during such crises, moral development is challenged to grow" (sawa 2007, p. 304) . a pragmatic approach would be to streamline the health system. administrators could anticipate ahead of time the scarcity of resources (vaccines, drugs, ventilators, and hospital beds); assess people's values on their distribution; and train health care workers to make decisions about what would be required of them in the future. consideration of a pandemic from a moral perspective would challenge providers to consider how they would face different kinds of moral reasoning: level 5 is that of justice without mercy (i.e., strict utilitarianism); level 2 "is the level of love based on respect. this level is based not on our love, but on how god loves us." level 1 transcends this level to one of self-sacrificing love. it requires a flexible balancing between the individual, and the society or community. ultimate guidance during a pandemic is neither deterministic nor egoistic. it embraces the needs of all parties the provider could help. the precepts of our current healthcare providers and public health practitioners are guides for future health professionals. for the last 5 years, michigan state university and the university of michigan school of public health have been hosting the new genomic framework for schools and communities curriculum in the underserved cities of detroit and flint, michigan. this national institutes of healthfunded program has brought an understanding, through classroom experiences and community action projects, of diabetes (sixth grade) and addiction (seventh and eighth grades) to middle school students, their families, and the surrounding community (bayer et al. 2018 ). an addiction curriculum panel and mini-workshops composed of adults judging the student projects-representatives from the county health department, health insurance plans, a health research center, and universities-gave students a look at professions that could one day be theirs. the closing event questionnaires and adult interviews also demonstrated an educational type of health preparedness. a teacher attending a diabetes closing event said that he learned about healthy foods and how to prevent diabetes from the students and the professional speaker. parents interviewed shared how the youngsters learned about diabetes in their father and grandmother, and came home talking about what they eat. a number of students explored the different types of chronic disease which happen to be risk factors in the current dilemma. detroit closing event participant #19, a parent, revealed, "she likes to look up different stuff to her question of the day. one example-she looked up stuff about breast cancer, diabetes, and asthma on the internet." a third level of awareness demonstrated by student and attending community member comments involved connection with broader issues, such as associations with conditions like obesity, and the availability of healthy foods in the inner city. the science education partnership award (sepa) program is one way of educating students and their families about chronic disease risk factors, and how they tie in with broader social conditions. detroit and most other american cities are currently experiencing a shortage of resources-testing kits, respirators, and beds-the very items dr. sawa's article anticipated. in a city in which one-third of the residents are poor, it would be expedient to provide care to only those who can afford it. scripture has a perspective on resource bottlenecks. father stanley harakas relates the eastern orthodox view: "neither the ability to pay nor an aristocratic criterion of greater human value or worth is acceptable. … in spite of the enormous difficulties involved, the ethical imperative from the orthodox perspective calls for the widest distribution of health care and life-protecting resources facilities and resources, rather than a concentration of such resources for the select few" (harakas 1980, pp. 26-27) . laurie zoloth, ethicist and jewish studies scholar, refers to isaiah 68:2 that the poor person is to be valued far above the king: "this is the fast i desire: … it is to share your bread with the hungry, and to take the wretched poor into your home. when you see the naked, to clothe him and not to ignore your own kin" (zoloth 1999, p. 245) . the 2019 revision of the public health code of ethics views health justice and equity as core values: "human flourishing requires the resources and social conditions necessary to secure equal opportunities for the realization of health and other capabilities by individuals and communities. … in addition, health justice does not pertain only to the distribution of scarce resources in transactions among individuals; it also involves remediation of structural and institutional forms of domination that arise from inequalities related to voice, power, and wealth" (apha 2019, p. 5). the attempt in 1994 to establish universal health care by the clinton administration considered health insurance to be a social good, everybody's right. this view can be contrasted with that of the current freedom caucus in the usa, which is that government should not be in the business of providing health insurance, and that it is to be considered a market good (mack 2019) . the 2010 patient protection and affordable care act (aca) has acted under the first premise, despite having been moved closer to the middle since its inception. among its accomplishments, the aca has provided health insurance to 20 million americans who would not otherwise own it. as part of this figure, 14.7 million individuals have been enrolled into medicaid and the child health insurance program as a result of medicaid expansion granting eligibility to people with incomes up to 138% of the poverty level. large numbers of people with or at risk of covid-19 are now entering hospitals through emergency room doors. hospitals are required to pay for care for those unable to afford it, while the patient remains in emergency, but not to provide follow-up care, such as for surgery or chronic conditions like cancer and diabetes (mack 2019) , risk factors that underlie coronavirus susceptibility. the societal decision in favor of health care as a social good remains vitally important during the outbreak. the aca has additionally mandated new irs requirements for both public and private hospitals to perform a system-wide check-up called a "community health needs assessment" every 3 years, and to adopt an implementation plan addressing community needs. these chnas have come to the aid of high racial-ethnic composition, low-income populations in cities like the bronx of new york, south chicago, and detroit. the top three stakeholder identified social determinants of health needs in the 2019 detroit henry ford health system chna were: poverty/low income (#1 social issue); housing (#2); and access to healthy food (#3) (henry ford health system 2019, p. 43). the michigan behavioral risk factor survey 2014-2016 shows that 33% of detroit residents are overweight and 37% are obese, health characteristics the chna reports to be on the rise. in addition, the henry ford macomb hospital, located north of detroit, reported diabetes as a priority area. implementation goals in these locations-increased consumption of fruits and vegetables and reduction of body mass index (bmi) in diabetic patients-bear more than a passing resemblance to the dietary and exercise-related lessons in our middle school genomics curriculum, leading us to believe we have given shape to at least a few students' future ambitions. we appreciate that other states will have different priorities. south of the michigan border in franklin county, ohio, which contains that state's metropolitan capitol, columbus, chronic conditions are #5 on the list of prioritized health needs, and infectious diseases (vaccine-preventable infections, sexually-transmitted diseases) are #6 (mount carmel health system 2019, p. v). the health priorities in both states' health systems are relevant to the theme of coronavirus prevention. in the 2019 henry ford health system chna, input was gathered by a variety of mechanisms, including stakeholder surveys, focus groups, and community member feedback. the types of organizations providing input to the chna were health-related, educational, civic, and faith-based, among other categories. in detroit, 5 of the 11 organizations providing input were faith-based (e.g., second baptist church of detroit, lord of lords church, and faith community nursing). our research team has long been aware of the importance of religious community-based organizations for recruiting grass-roots participants for values discussions and dialogs relating to new health interventions. in our nih-funded communities of color and genetics policy project looking at people's attitudes toward new genetic technologies, 5 of the 14 participating community organizations were faith-based (e.g., bethel ame church in ann arbor, mi; faith access to community economic development in flint, mi; and clinica santa maria in grand rapids, mi) (bonham et al. 2009, p. 336) . members of these churches and organizations were entirely african-american and latino, affording a distinct look at the hopes and concerns of people who have experienced marginalization, discrimination, and transience in their own lives. detroit has many active communitybased organizations. the churches and other faith-based organizations are especially aware of the social obstacles and healthcare deficits experienced by their community members. religious involvement in health promotion represents both sides of the coin. on the heads side, religion serves as a source of hope, which is greatly needed emotionally and in a life-sustaining sense during the current crisis. on the other side, religion provides practical services that bolster health and welfare. many people consider themselves more spiritual than religious, but it is the organized nature of religious institutions that is coming to the rescue during the widespread financial and food shortages being experienced. in public health, we consider health promotion to be mediated by health facilitators and deterred by health barriers, which are often physical factors or people advocating for health (kieffer et al. 2005, p. 149 ). in the current dilemma, religion as a health promoter is active in terms of what the churches, temples, and mosques are accomplishing, and their members are carrying out. it is important to recognize that churches have been longstanding partners in health promotion along with public health and medical organizations. lasater and colleagues divide health-related church activity into four levels: (i) the church serving only as a venue for recruiting participants into collaborative health programs; (ii) the intervention delivery occurs on-site at the church, e.g., educational sessions and group classes; (iii) involvement of congregation members in program delivery, as might be carried out by trained lay health workers from within congregational ranks; and (iv) delivery of program elements that include both health messages and religious readings, such as scriptural or ethical guidance, that link religion and health (campbell et al. 2007, p. 217; lasater et al. 1997, pp. s49-s50) . a level ii diabetes prevention program implemented in 15 bronx and harlem churches in new york was aimed at improving nutrition and physical activity levels utilizing a consultant fluent in spanish from the community with a faith orientation, and another who was a nutrition and diabetes educator (gutierrez et al. 2014) . a level iii prevention program aimed at obesity, diabetes, and hypertension in 8 african-american mississippi delta churches contained dietary/physical activity educational sessions led by program staff and a trained church committee member (tussing-humphreys et al. 2013) . a level iv diabetes prevention program in 20 african-american churches in augusta, georgia, was based on 12 core information and risk improvement sessions and utilized input from a community (faith-based) and university advisory board in all aspects of project planning. the board's recommendations resulted in the inclusion of select scriptures and sociocultural preferences in the group lifestyle balance curriculum (sattin et al. 2016) . these programs registered statistically significant outcomes in regards excess eating, blood glucose levels, physical activity level, and personal weight; two involved control arms; and the bronx-harlem program stratified results by race-ethnicity, including identification of group-specific obstacles and motivating factors. churchbased programs are not contoured for late secondary prevention; that is, treating the manifestation of disease like diabetes or cancer. however, they do have a place in primary prevention of disease by mitigating the risk factors involved. the effects of these three programs will not end when the programs themselves end. the church participants are left with new knowledge and tools which can be utilized at any time. in fact, most people during the pandemic have found themselves sequestered to home, where time exists to engage in one's preferred physical activity, and to manage the content of meals, at least as far as these practices relate to the first three chronic disease risk factors for covid-19. pondering the universe's vastness and our capacity to take a fall while traversing it, emerson affirmed, "we judge of a man's wisdom by his hope" (emerson 1951, p. 98) . compared to tangible interventions, hope is a more abstract quality, but one that can lead to health and the will to seek it. paul scherz (2018) delineates three stances toward scripture that pertain to personalized medicine: (1) setting aside anxieties over risk and leaving worldly concerns to god's care; (2) using natural regularities to provide security while realizing that the future is in god's hands; and (3) looking to social factors that structure risk, such as friends or the work environment. these avenues of hope can be generalized to the diversity of religious faiths. while the first stance has been used in decisions over whether to except a newborn from neonatal blood screening, the consequences of leaving population health purely to god and fate during a pandemic are quite stark. even invoking the goal of herd immunity free of intervention would lead to hundreds of thousands of deaths. better an appreciation that god, or one's personal definition of a universal presence, abides with us as we experience calamity and take whatever steps seem wise. indeed, a british study on the knowledge and beliefs of patients newly diagnosed with cancer found that fatalistic beliefs ("cancer is caused by fate and nothing can be done to prevent it") explained only 4.6% of the variance in anxiety scores over the spread of cancer (lord et al. 2012, p. 8) . other attitudes toward the spread of disease supersede a sense of fatalism in people's hopes and fears about what might eventuate. a sense of hope provided by religion can determine whether one engages in healthy practices in the disease context or lets things slide. two interviews from patients with diabetes, the second recovering from a lower leg amputation, depict this stance: my happiness would be within him. … and when i'm at peace, then my body is at peace. i start doing things, i start going to church or wherever i need to go to worship, exercise, time for this and that (choi and hastings 2019, p. 10 ). [spirituality] helps to get by, just like every day. it helps with getting out of bed and getting on with the day, and just do something. it helps to try to walk and "i can do it, yes i can do it, i can do it …" and i can't do it now, but i can do it, i will do it (unantenne et al. 2013 (unantenne et al. , p. 1153 . these statements also apply to conditions in the middle of the covid pandemic. healthy people out of work and without the normal activities of daily living need inspiration to keep moving. for people grieving a loved one or personally recovering from the virus, a sense of hope can help them to simply get through the day. a third patient refers to the hope spirituality can give through people on whom one can rely: it does help me because you realize you've got support … you've got other people of a like mind around you, and it gives you the strength to keep going … a vision that goes alongside your everyday living. you draw strength from it for everyday living … (unantenne et al. 2013 (unantenne et al. , p. 1152 ). in the inner city, other people can be very helpful in times of crisis. detroit has stories of teachers going to homes and asking what residents need, immigrant specialists delivering diapers and food to their clients, and neighbors tilling the soil of nearby community gardens for each other as summer approaches (alvarez and clark 2020) . churches that allowed ten congregants per service early in the outbreak, which provided emotional support to helpers and those being helped alike, have stopped this practice in the wake of state disease prevention rules promulgated by gov. gretchen whitmer. places of worship have been determined and resourceful, though, adapting to circumstances by holding drive-in (in-vehicle) and online services, and transmitting messages of hope on the social media. in detroit, places of worship have been responsive and adaptive to policy. perhaps, the biggest transmitted message of hope was delivered by renowned italian opera singer andrea bocelli on easter sunday 2020 when he conducted a one man performance entitled "music for hope" in the foreground of milan's duomo cathedral with the goal of uniting the world during the pandemic. the mission was a success, breaking live-stream classical music records with an all-time 35 million views. the most evident symbol of religious involvement in sustaining the health of detroit citizens during the pandemic lies in the essential social services the churches are performing. residents are reeling from inability to go to work and the closure of food establishments. the city is already known for being a "food desert" marked by a shortage of nearby grocery stores and healthy food markets. here is an example listing of the services churches are rendering during the outbreak: these services are most frequently performed on behalf of those who for a variety of reasons have been marginalized from what most families take for granted, though with the outbreak, this circle has enlarged. the persons and organizations delivering these services are the unsung heroes of covid-19. we are especially appreciative of the laptop provision to young students (allen 2020), having tested with our middle school students the use of chromebooks and ipads to visualize how genes interact with the environment in sand rat simulations and to model the effects of gene-environment interactions on health using a dynamic model building program, and found that computers seem to be a favored learning method among middle school students! schools are closed during the pandemic, but not all families have computers to upload online lessons. triumph's generous efforts will help both young students and their families. the educational project is a collaboration; the schools themselves provided the digital device and computer laboratory access. neighbors preparing community gardens for each other; deliveries by one community resident to another; social services being performed by the churches; churches securing laptops for young students during school closure-these attributes are known as "community assets" (wallerstein et al. 2005, p. 34) . in the midst of calamity, detroit is both depending on an expert healthcare system and bringing its own community assets to bear. charles dickens opens his classic novel a tale of two cities with the well-known statement: "it was the best of times, it was the worst of times … it was the season of light, it was the season of darkness, it was the spring of hope, it was the winter of despair…." (dickens 1997, p. 13) . though this passage was directed at the contrast between british and french society and the haves and have nots, it very much applies to current circumstances, especially to urban centers swirling in the eye of the pandemic. divisions exist between the different sectors and those who have enough to get by living alongside families barely surviving. the city's functioning displays the socio-ecological model in operation, not just as a chalkboard conception (modell et al. 2013, p. 114; campbell et al. 2007, pp. 215-216) . the overall incidence of infection depends on its incidence among population subgroups, which is contingent on its diagnosis at the site of testing. access to medical care is linked with steps that are being taken in the work environment and home environment. the survival of critical cells helps assure functioning at the organ level (heart, lungs, and immune system), which governs an individuals' health, with influence from their surrounding family, community, and the country's level of preparedness. the two vectors in the model-"the world affects us" and "we affect the world"-represent the necessary collaboration taking place, a bit different from the social clashes of dicken's novel. the newspapers of mid-april provide a slice in history of a city roiling in pandemic yet arched toward recovery if the fates will permit it. one can trace different strands in the city's reaction. the pandemic has affected each individual to the core, exposing deeply human emotions. people working together, and unfortunately the spread of disease between people, show it to be a social phenomenon, with churches as salutary, ever working participants. for scientists and medical and public health practitioners, it is a time of great, amassed energy, trying to contain the spread and keep people alive. in the april 27/may 4, 2020, "finding hope" special issue of time magazine, the dalai lama captured this point in history with the following words: this crisis shows that we must all take responsibility where we can. we must combine the courage doctors and nurses are showing with empirical science to begin to turn this situation around and protect our future from more such threats. … as a buddhist, i believe in the principle of impermanence. eventually, this virus will pass, as i have seen wars and other terrible threats pass in my lifetime, and we will have the opportunity to rebuild our global community as we have done many times before (dalai lama 2020, p. 54). in dickens' great expectations, the protagonist philip pirrip ("pip") is the beneficiary of an unexpected fortune, but at the same time he experiences hardships from the continued aloofness of estelle, the imprisonment and death of his benefactor, magwitch, and the consequent loss of his (pip's) fortune to the crown and by helping his friend financially (dickens 1996, pp. 299, 458, 461) . toward the very end pip has regained his footing through sheer work and self-initiative to become a senior partner in his friend's firm, and in dickens' revision the hint exists that the cruelties of life have made estelle into an enduring companion. before the crisis, the view from the tall buildings of detroit was of a city on the rise. the covid-19 pandemic has gutted the health and well-being of the major american cities, with detroit at the front. on the road to recovery, which is matter of time, patience, and collective effort, detroit's residents and those in the surrounding communities will surely depend on the types of faith the dalai lama has articulated. detroit church adapts to pandemic with drive-in services, loaner laptops for students in battle-tested detroit, neighbors help each other as coronavirus spreads public health code of ethics why covid-19 is a disaster for detroit impact and lessons learned from a school-academic-community partnership in sharing urban youth community research projects on type-2 diabetes as a health promotion strategy community-based dialogue: engaging communities of color in the united states' genetics policy conversation church-based health promotion interventions: evidence and lessons learned interim guidance for administrators and leaders of community-and faith-based organizations to plan, prepare, and respond to coronavirus disease 2019 (covid-19) religion, spirituality, coping, and resilience among african americans with diabetes great expectations a tale of two cities spiritual laws. emerson's essays, 1st and 2nd series hospitalization rates and characteristics of patients hospitalized with laboratory-confirmed coronavirus disease 2019-covid-net, 14 states detroit: america's next covid-19 hotspot battles to prepare for coming surge evaluation of a multicultural faith-based diabetes prevention program for the health of body and soul: an eastern orthodox introduction to bioethics community health needs assessment henry ford health system covid-19 cases the public health impact of covid-19: why host genomics? the application of focus group methodologies to community-based participatory research thoughts, not prayers synthesis of findings and issues from religious-based cardiovascular disease prevention trials the beliefs and knowledge of patients newly diagnosed with cancer in a uk ethnically diverse population what america needs to decide: is health care a market good or social good? michigan's covid-19 cases, deaths hit blacks disproportionately. detroit news vital statistics-selected chronic disease indicators, wayne county health department residents covid-19 update the ecological model in genetics and religion 2019 community health needs assessment in the poorest big city in america, he's bringing the health department back to life community trial of a faith-based lifestyle intervention to prevent diabetes among african-americans bioethics for the twenty-first century. ultimate reality and meaning: interdisciplinary studies in the philosophy of understanding risk in christianity and personalized medicine: three frameworks for understanding risk in scripture total number of cases of coronavirus (covid-19) in the united states as of number of deaths from coronavirus (covid-19) in the united states as of a church-based diet and physical activity intervention for rural, lower mississippi delta african american adults: delta body and soul effectiveness study the strength to cope: spirituality and faith in chronic disease developing and maintaining partnerships with communities health care and the ethics of encounter: a jewish discussion of social justice the authors extend their gratitude to irene bayer for reviewing the sepa projectrelated portions of the manuscript. key: cord-009278-98ebmd33 authors: ferreira-coimbra, joão; sarda, cristina; rello, jordi title: burden of community-acquired pneumonia and unmet clinical needs date: 2020-02-18 journal: adv ther doi: 10.1007/s12325-020-01248-7 sha: doc_id: 9278 cord_uid: 98ebmd33 community-acquired pneumonia (cap) is the leading cause of death among infectious diseases and an important health problem, having considerable implications for healthcare systems worldwide. despite important advances in prevention through vaccines, new rapid diagnostic tests and antibiotics, cap management still has significant drawbacks. mortality remains very high in severely ill patients presenting with respiratory failure or shock but is also high in the elderly. even after a cap episode, higher risk of death remains during a long period, a risk mainly driven by inflammation and patient-related co-morbidities. cap microbiology has been altered by new molecular diagnostic tests that have turned viruses into the most identified pathogens, notwithstanding uncertainties about the specific role of each virus in cap pathogenesis. pneumococcal vaccines also impacted cap etiology and thus had changed streptococcus pneumoniae circulating serotypes. pathogens from specific regions should also be kept in mind when treating cap. new antibiotics for cap treatment were not tested in severely ill patients and focused on multidrug-resistant pathogens that are unrelated to cap, limiting their general use and indications for intensive care unit (icu) patients. similarly, cap management could be personalized through the use of adjunctive therapies that showed outcome improvements in particular patient groups. although pneumococcal vaccination was only convincingly shown to reduce invasive pneumococcal disease, with a less significant effect in pneumococcal cap, it remains the best therapeutic intervention to prevent bacterial cap. further research in cap is needed to reduce its population impact and improve individual outcomes. also high in the elderly. even after a cap episode, higher risk of death remains during a long period, a risk mainly driven by inflammation and patient-related co-morbidities. cap microbiology has been altered by new molecular diagnostic tests that have turned viruses into the most identified pathogens, notwithstanding uncertainties about the specific role of each virus in cap pathogenesis. pneumococcal vaccines also impacted cap etiology and thus had changed streptococcus pneumoniae circulating serotypes. pathogens from specific regions should also be kept in mind when treating cap. new antibiotics for cap treatment were not tested in severely ill patients and focused on multidrug-resistant pathogens that are unrelated to cap, limiting their general use and indications for intensive care unit (icu) patients. similarly, cap management could be personalized through the use of adjunctive therapies that showed outcome improvements in particular patient groups. although pneumococcal vaccination was only convincingly shown to reduce invasive pneumococcal disease, with a less significant effect in pneumococcal cap, it remains the best therapeutic intervention to prevent bacterial cap. further research in cap is needed to reduce its population impact and improve individual outcomes. keywords: cap; community-acquired pneumonia; epidemiology; infectious disease introduction community-acquired pneumonia (cap) is a frequent and deadly infection, having considerable implications for healthcare systems worldwide. cap is responsible globally for 3 million deaths annually [1] . poor outcomes are usually related to cap severity and patient characteristics and co-morbidities. some recent advances emphasise in the importance of continuous research in cap. cap classification has varied over the last 20 years. recently, american guidelines [2] abandoned healthcare-associated pneumonia (hcap) because of the lack of evidence showing differences in microbiology of cap and hcap. this definition change could introduce differences in epidemiological reporting. important advances in cap have also been reported since pneumococcal vaccines and diagnostic tests for viruses. recently, nature medicine published the first use of phages to treat a multidrug-resistant (mdr) microorganism [3] and lancet infectious diseases reported the first use of pneumolysin in severe cap treatment added to standard of care in a phase ii trial [4] . these advances emphasise the importance of continuously updating cap management and research and development. in this review, we aim to provide a perspective of cap burden that is critical to allocating resources to improve patient outcomes and also to support new research focused on unmet clinical needs. this article is based on previously conducted studies and does not contain any studies with human participants or animals performed by any of the authors. in europe, cap incidence varies widely ranging from 20.6/10,000 in iceland [5] to 79.9/ 10,000 person-years in the uk [6] . data from italy [7] in adults (over 15 years of age) between 2005 and 2019 reported cap incidence between 29.3 and 30.6 per 10,000 inhabitants and a hospitalization rate lower than 10% within 60 days from diagnosis. in france, cap incidence is estimated as 47 per 10,000 person-years [8] with 7% of patients being admitted in the 30-day period after cap diagnosis. in the usa, in adults under 65 years old, cap incidence varies between 24.8/10,000 personyears [9] and 106/10,000 person-years [10] . moreover, as expected, elderly people have a higher incidence, representing 63.0/ 10,000 person-years in 65-79-year-olds and reaching 164.3/10,000 person-years after 80 years old. a study in latin america (including argentina, paraguay and uruguay) reported incidence varying between 4.8 and 110/10,000 person-years in people aged 18--64 years and 109-294/10,000 person-years in those over 65 years [11] . another study in latin america (argentina, brazil, chile, colombia, mexico and venezuela) reported cap incidence varying between 32.6 and 80.4/10,000 personyears in a population over 50 years [12] . south korea has an incidence rate of 62.6/ 10,000 person-years [13] with high importance of pneumococcal pneumonia [14] . cap incidence in japan in middle-aged adults (55--64 years) is 65/10,000 person-years, increasing markedly over age to 169 and 434/10,000 person-years in adults aged 65-74 years and 75--84 years, respectively. a recent study of three asian countries [15] reported that cap is responsible for 1424.5, 420.5 and 98.8 episodes per 10,000 discharges in the philippines, indonesia and malaysia, respectively. in china, cap incidence is estimated as 29.8-221.0 per 10,000 admissions including children [16] . in australia, a study between 2011 and 2013 reported an incidence of 24.5/10,000 personyears [17] in patients older than 20 years. an australian study estimated cap incidence in all age groups (including children) as 161.3/ 10,000, rising to 319.3/10,000 and 659.9/ 10,000 person-years in patients between 65 and 74 years and over 75 years, respectively [18] . a retrospective analysis in new zealand estimates cap incidence as 85/10,000 in the general population and 188.2/10,000 in patients older than 65 years [19] . table 1 summarizes global data on cap incidence in adults. to properly analyze this data it is important to keep in mind that the real clinical incidence of cap is difficult to determine because of differences in reporting and case selection from epidemiological studies. cap notification is optional even in developed countries, except when presenting as invasive pneumococcal disease (when cap is accompanied by the identification of pneumococcus in sterile fluids such as blood, cerebrospinal fluid, and pleural, joint or peritoneal fluid) and legionnaires disease in some countries. worldwide differences in access to healthcare services also preclude direct comparison of incidence [20] . furthermore, scarce data are available from primary care or representing patients treated in ambulatory settings. moreover, cap incidence varies considerably according to geographic location, study methods, case definition and study population [21, 22] . cap incidence varies and is also highly influenced by age and co-morbidities (such as chronic obstructive pulmonary disease, diabetes mellitus, renal failure, congestive heart failure, coronary artery disease and liver disease). a seasonal effect that doubles the rate of pneumonia in the winter months impacts, additionally, incidence studies [23] . according to the world health organisation (who) data, lower respiratory tract infections are the primary infective cause of death globally accounting for 6.1% of deaths [24] . the global burden of disease 2016 study showed that deaths from low respiratory tract infections decreased both in the total number of deaths 8.2% (95% ui, -12.4, -3.9) and age-standardized rates 22.4% (95% ui, -25.3, -18.9), from 2006 to 2016 [25] . in the usa, cap causes around 102,000 deaths per year, a mortality of 13%, 23.4% and 30.6% at 1 month, 6 months and 12 months, respectively [26] . cap alone is responsible for at least 23,000 deaths annually in europe [27] . one-year cap mortality in canada is estimated as 28% [28] . in the asia-pacific region cap mortality is estimated between 1.1% and 30% [29] . in low-income countries, mortality tends to be higher, as proved in a study addressing mortality in lowincome countries that showed higher mortality than in high-income countries, reporting a mortality rate of 23% in cambodia, 19% in senegal, 18% in uganda and 16% in the central african republic [30] . mortality occurs largely in hospitalized patients (6-20%) [22, 26, 31] , but it varies widely according to treatment setting and severity disease, while mortality in primary care and ambulatory patients is inferior to 1% in most of the population, rising in patients over 65 years [7, 8] . one-ninth of patients hospitalized with cap will need intensive care unit (icu) admission because of severe respiratory failure, severe sepsis, or septic shock [32, 33] and cap mortality in these patients remains very high, reaching near 50% [32] . a progressively higher incidence of severe cap was reported in icu, but the mortality rate had decreased by 18% over a 15-year period [34] . data reporting on severity could be driven by reimbursement and, therefore, not represent a real increase in severity cap. patients who had been treated in the hospital for cap have a clinically significant long-term poor survival when compared to matched controls. this increased post-discharge mortality is driven by pulmonary complications, new cap episodes and cardiovascular events, probably in the course of a persistent inflammatory response [32, 35] . cap mortality reflects the enrollment of different patient populations in epidemiological studies as well as their methodology. hospital and icu admission criteria vary among different countries and hospitals, which hinders a comparison between them. different admission criteria across countries, as well as the availability of icu dedicated beds, technological and human resources could change reported mortality, as well as data regarding icu admission. other factors such as guideline adherence and quality of care could also reduce mortality [36] . this data is infrequently reported in epidemiological studies. numerous patient risk factors and co-morbidities can hardly affect disease severity as well as the risk of death. patient risk factors age, co-morbidities and immune status, together with microbiological pathogens and the absence of response to treatment also influence mortality [23] . despite most of cap episodes being caused by few microorganisms, several bacteria, viruses and fungi are recognized as causes of cap. however, even when prospective studies were performed, less than half of patients presenting with cap had a microbiologic diagnosis [9, [37] [38] [39] . important variations are found according to patient severity and used diagnostic tools. the emergence of new diagnostic tests improved the recognition of pathogens compared with previous tests [40] , not only for viruses but also for bacterial pathogens, allowing earlier directed therapy and antibiotic deescalation. a higher rate of microorganism isolation was reported when newer diagnostic approaches and molecular techniques were used [39] [40] [41] . some of these approaches are not widely available in clinical practice and their use remains controversial because no studies prove their outcome benefits and tests are costly. moreover, antiviral agents are inactive against some viruses which precludes the utility of viral identification in clinical practice. streptococcus pneumoniae remains the most isolated bacterial pathogen in cap worldwide in all treatment settings (outpatient, general ward and icu) [37, 39, 40, [42] [43] [44] [45] [46] . s. pneumoniae resistance patterns remain different across countries. in recent studies, mycoplasma pneumoniae, chlamydia pneumoniae and legionella pneumophila, which are well-established causes of cap, have been isolated more frequently than before [19, 22, 47, 48] (table 2) . however, except for l. pneumophila, the diagnosis is difficult in clinical practice but could improve with multiplex pcr tests. haemophilus influenzae account for 1.2-19% [49, 50] of all cases of bacterial cap; however, this rose to around 50% in some studies [40] . h. influenzae is a major public health problem because of its increasing antimicrobial resistance. given this resistance, specially to beta-lactams, h. influenzae was listed in the priority list of who antibiotic-resistant bacteria [51] . unlike in other global areas, gram-negative pathogens are also frequent pathogens (mostly klebsiella pneumoniae and burkholderia pseudomallei) in asia. meloidosis is a life-threatening infectious disease (caused by b. pseudomallei) that is endemic in south and southeast asia, northern australia and china, peaking in the wet season. in some places, it is the third most common deadly disease after hiv and tuberculosis. pneumonia is the most frequent presentation, with a mortality rate reaching 21% [52, 53] , related to shock and bacteremia. several cases are also reported in travellers returning from endemic areas [54, 55] . even subject to some variations, generally methicillin-resistant s. aureus and mdr gramnegative bacilli together cause cap in approximately 5% of patients [56, 57] , presenting even lower incidence in non-critically ill patients. while their empirical coverage is almost always unnecessary in cap, in some areas and in patients with specific risk factors it could be considered; thus, inappropriate therapy is related to increasing mortality. the precise role of viruses in cap is not yet well established e.g. pathogens, co-pathogens, triggers or all-in-one. respiratory viruses are isolated in up to one-third of patients with cap [58] [59] [60] . however, it is not straightforward to rw review article, r retrospective study, p prospective study, nr not reported assume that the presence of virus isolates in nasopharyngeal swabs (as performed in most studies) is sufficient to explain cap pathogenesis. almost all studies (table 3) using polymerase chain reaction (pcr) reported influenza, rhinovirus and respiratory syncytial virus (rsv) as the commonest isolated, but whether they are true pathogens remains debatable. metapneumovirus was first described as a pathogen in children; however, it also infects adults, but the incidence is lower than in children [61] . adults can carry the virus asymptomatically. however, it was recognized as a single cap pathogen in 4% of patients in the usa [9] and recently had been implicated in severe cap [61] . similarly to other viruses, metapneumovirus appears to have a seasonal variation with a peak after influenza season. microbiology remains of utmost importance given that it has a significant prognostic impact. cap unmet clinical needs set priorities for research topics in cap therapy and prevention through vaccines, that are, in our opinion, important to be perform in the next few years, table 4 . in the last decade, many efforts were made to develop new drugs, resulting in newly approved antibiotics listed in table 5 . however, new antibiotics were often being developed to improve their activity against several mdr microorganisms, which are, as previously shown, uncommon in cap. most of these trials focused on patients with non-severe cap requiring hospitalization [62] [63] [64] [65] [66] [67] [68] , excluding severely ill patients (or icu patients), so recommendations for these groups of patients are why is evidence of short duration antibiotic therapy in cap not applied in clinical management? which patients should be treated with antiviral therapy in cap? should antiviral therapy be used empirically during influenza seasonal epidemics or all year? could pk/pd interventions change the outcomes in severe cap? in non-severe cap might new oral antibiotics be directed to once-daily dosages? what is the role of tetracyclines in cap treatment? in severe cap what is the best drug on top of beta-lactam therapy: macrolide or quinolone? adjunctive therapies which patients will benefit from steroid therapy in cap? what are the best steroid, steroid dose and duration in cap? in patients with cap presenting with high inflammatory response, can steroid therapy improve hard outcomes? how should viral infection be excluded before steroid treatment? can steroids and macrolides have an addictive anti-inflammatory effect? is pcv13 superior to ppv23 in invasive pneumococcal disease and pneumococcal cap? which is the best scheme/schedule of anti-pneumococcal vaccination? is vaccine efficacy equivalent in immunocompetent and immunosuppressed patients? is adult pneumococcal vaccination cost-effective in settings with high childhood vaccination rates? will vaccines directed to s. pneumoniae virulence factors be more efficient than current ones? new randomized controlled trial (rct) to study performance of new drugs in patients with severe cap (psi [ 120, port class v) which is the epidemiology of lethal cap? what is the real burden of morbidity and mortality after cap? how should microbiologic surveillance be performed in a global way? derived from studies without their representation. it is an important limitation for the widespread use of new antibiotics, in spite of drug usage specificities in critically ill patients. studies are needed in more severely ill patients. rcts showing superiority instead of ''non-inferiority'' are needed to show a clear advantage of new drugs. in the period after introduction of new antibiotics, microbiological resistance surveillance remains essential because of new antibiotic pressure among pathogens, which could lead to resistance. long-term side effects should also be studied. several therapies have been tested to improve cap outcomes using different strategies, to target innate immunity and adaptive immunity, as well as other immunomodulatory or anti-inflammatory drugs. for the purpose of this review we focus on adjunctive therapies to steroids and macrolides that are clinically available and the subject of many studies. difficulties in showing an impact on hard outcomes, and difficulties in properly identifying the patients that will benefit more of them, impair the use of adjunctive therapies. furthermore, as these therapies focus mainly on the inflammatory response, long-term outcome studies should be performed to analyze how they modulate long-term mortality that is related to chronic inflammatory status. the use of steroid therapy in patients with bacterial cap remains uncertain, mainly because of the lack of knowledge about which phenotypes of disease and patient groups will have greater benefits from this therapy. inflammatory response contributes to cap mortality. steroid therapy reduces the inflammatory response and is therefore believed to improve outcomes in patients with cap . however, this assumption remains controversial because of conflicting results regarding mortality [69] [70] [71] [72] [73] . although it is likely to enhance patient performance, the published positive results focused on soft outcomes (reduction of treatment failure, length of stay, progression to acute respiratory distress [69] [70] [71] [72] [73] . steroid treatment depending on high inflammatory response should also be retested addressing hard endpoints [74] because the previous published rct used radiological improvement as a primary outcome. the only study that established mortality as the primary outcome [75] has not yet been published. precise identification of patients that will benefit from steroids is critical, given that these drugs have important side effects. steroids have the potential to reduce survival in viral respiratory infections. the ideal method to convincingly exclude viral infection before steroid therapy initiation should also be addressed. for that, new studies are needed in specific populations (i.e. studying separately severe and non-severe cap) to improve the body of evidence about steroid usage in cap. macrolide therapy is used frequently in respiratory diseases for its antimicrobial activity and anti-inflammatory effects. several in vitro and in vivo studies proved this ability through a reduction in pro-inflammatory interleukins and improved levels of anti-inflammatory ones, as well as the ability to reduce polymorphonuclear neutrophil (pmn) recruitment and decrease reactive oxygen species [76] [77] [78] [79] [80] . the clinical meaning of these findings remains controversial because, for now, there is no randomized clinical trial confirming the superiority of therapies containing macrolides regarding mortality [81, 82] . however, observational studies [83] [84] [85] [86] showed consistently improved outcomes in invasive pneumococcal disease in severely ill patients (i.e. invasively ventilated and under vasopressor treatment). some guidelines [87] [88] [89] [90] recommend use of macrolides in combination therapy with betalactams as first-line therapy in cap, either in icu and non-icu patients. those recommendations were mainly driven by observational studies that are subject to bias. evidence from recent rcts [91] , failed again to show the advantages of this approach in non-critically ill patients that had never been clearly shown. the generalized use of macrolides has the potential to promote antibiotic resistance, so until an rct shows evidence of benefit macrolides should be judiciously used in non-critically ill patients, whereas macrolides are associated with qtc interval prolongation, gastrointestinal events and drug interactions. pneumococcal vaccination [92] , where the vaccination rate is higher, contributes to pneumococcal vaccine-type disease reduction. data regarding herd protection is not consensual, but its disparity could be explained by the different time intervals between generalized vaccination and studies [93, 94] . further, vaccine introduction also leads to serotype shifting; meanwhile, no effects in resistance patterns were noted [95] . several efforts were made to develop a vaccine to prevent pneumococcal infection resulting in two available vaccines: pneumococcal polysaccharide 23-valent (ppv23, contains capsular polysaccharides of 60% of serotypes causing disease in adults) and pneumococcal conjugate 13-valent (pcv13, stimulates antibody production against 28-42% of serotypes causing disease, varying according different geographical areas). for both, vaccine efficacy has been proven for invasive pneumococcal disease [96, 97] . only pcv13 has been clearly associated with the prevention of non-invasive and invasive pneumococcal community-acquired pneumonia (capita trial [97] ) regarding vaccine-targeted serotypes. in different countries, vaccine indications vary, some based on believing that pcv13 could boost immunity created by ppv23 (when previously administered) [98] . it is controversial whether pcv13 is superior to ppv23, because comparative trials are lacking. new outcomes should also be determined for invasive pneumococcal disease and pneumococcal cap, as well as all-cause mortality and pneumococcal cap-related mortality. the definition of immunosuppressed patients also varies according to different studies, which impairs the process of studying real immunosuppressive risk factors for pneumococcal infection. while in immunocompromised patients indications for vaccination are well established (table 6 ), in other groups evidence is less clear, allowing different recommendations in different countries. pneumococcal vaccine calendar, administration of one or both vaccines [99] , should be further elucidated in new studies. after introduction of vaccines, pneumococcal microbiology in cap moved to serotypes that are not included in vaccines [95] . new vaccines immunizing widely for other serotypes will be valuable, as well as other vaccine approaches targeting s. pneumoniae virulence factors. costeffectiveness of vaccination in adults should be evaluated to analyze whether high child pneumococcal immunization could modify its costeffectiveness in adults and the elderly. the large body of evidence discussed has exposed the high incidence and mortality of cap, usually related to older age and co-morbidities. cap microbiology had been changed because new diagnostic tests have turned viruses into the most identified pathogens, while their role in pathogenesis is not fully explained. adjunctive therapies should remain part of cap tailored management. vaccines should remain the backbone of bacterial cap prevention. further studies are needed to improve outcomes in patients with cap. funding. no funding or sponsorship was received for this study or publication of this article. authorship. all named authors meet the international committee of medical journal editors (icmje) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. ferreira-coimbra and cristina sarda have no conflicts of interest. jordi rello was nabriva advisor. jordi rello is a member of the journal's editorial board. compliance with ethics guidelines. this article is based on previously conducted studies and does not contain any studies with human participants or animals performed by any of the authors. open access. this article is licensed under a creative commons attribution-noncommercial 4.0 international license, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the creative commons licence, and indicate if changes were made. the images or other third party material in this article are included in the article's creative commons licence, unless indicated otherwise in a credit line to the material. if material is not included in the article's creative commons licence and 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pneumococcal pneumonia in adults sequential administration of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine in pneumococcal vaccine-naïve adults 60-64 years of age vaccines to prevent pneumococcal community-acquired pneumonia risk factors for community-acquired pneumonia in adults in europe: a literature review incidence and risk factor prevalence of community-acquired pneumonia in adults in primary care in spain (neumo-es-risk project) burden and risk factors of ambulatory or hospitalized cap: a population based cohort study burden of adult community-acquired, health-careassociated, hospital-acquired, and ventilator-associated pneumonia economic cost of community-acquired pneumonia in new zealand adults the burden and etiology of community-onset pneumonia in the aging japanese population: a multicenter prospective study incidence and case fatality rates of community-acquired pneumonia and pneumococcal diseases among korean adults: catchment population-based analysis severe community-acquired pneumonia requiring intensive care: a study of 80 cases from singapore relationship between clinical features and computed tomographic findings in hospitalized adult patients with communityacquired pneumonia etiology and risk factors for mortality in an adult community-acquired pneumonia cohort in malawi prevalence and etiology of community-acquired pneumonia in immunocompromised patients key: cord-355393-ot7hztyk authors: yuan, peiyan; tang, shaojie title: community-based immunization in opportunistic social networks date: 2015-02-15 journal: physica a: statistical mechanics and its applications doi: 10.1016/j.physa.2014.10.087 sha: doc_id: 355393 cord_uid: ot7hztyk abstract immunizing important nodes has been shown to be an effective solution to suppress the epidemic spreading. most studies focus on the globally important nodes in a network, but neglect the locally important nodes in different communities. we claim that given the temporal community feature of opportunistic social networks (osn), this strategy has a biased understanding of the epidemic dynamics, leading us to conjecture that it is not “the more central, the better” for the implementation of control strategy. in this paper, we track the evolution of community structure and study the effect of community-based immunization strategy on epidemic spreading. we first break the osn traces down into different communities, and find that the community structure helps to delay the outbreak of epidemic. we then evaluate the local importance of nodes in communities, and show that immunizing nodes with high local importance can remarkably suppress the epidemic. more interestingly, we find that high local importance but non-central nodes play a big role in epidemic spreading process, removing them improves the immunization efficiency by 25% to 150% at different scenarios. with the rapid pervasive of a new generation of smart devices, it is possible and necessary to disseminate content in networks by exploiting the human mobility and intermittent device-to-device contacts. networks with such intermittent device-to-device contacts are generally called delay-tolerant [1] or opportunistic [2] . until recently, a variety of opportunistic social networks (osn) have been studied, such as pocket switched networks [3] , publish/subscribe systems [4, 5] , and human contact networks [6] . many interesting phenomena have been observed, including the heavy-tailed distribution of contact times and node degree [7, 8] , the small world phenomenon [9] , the dynamics of epidemic spreading [10, 11] , the high clustering of aggregated social contact statistics [12] , etc. the social contact feature makes nodes in osn vulnerable to infection. therefore, when an infectious disease appears in a population (e.g., the severe acute respiratory syndrome (sars) and the h7n9 virus), designing effective immunization strategies has become very important. to achieve this goal, several immunization strategies have been recently developed, ranging from ring immunization [13] to targeted immunization [14] [15] [16] [17] [18] . the targeted strategy has shown to be more effective than the ring strategy to delay the outbreak of epidemic. the basic idea of targeted immunization is that it first ranks importance of nodes and then removes them, from highest importance to lowest, to observe their impact on epidemic spreading speed. the importance of nodes is generally measured by node's degree, closeness or betweenness centrality in the network [19] . to further improve the immunization efficiency, the authors of ref. [20] suggested that node importance should be recalculated after every step of node removal. previous work mainly concentrates on the global measures of nodes in a network, while ignoring the local importance of nodes in different groups. a number of recent studies indicate that opportunistic networks have a high clustered property [10, 21] and show a temporal community structure [22] . networks with properties at the level of community are quite different from their properties at the entire network level [23] . studies thus paying more attention to the whole network topology and neglecting temporal community structure may miss many interesting features. for example, in real world it is found that people have different average number of contacts in different social cliques. the same person in one clique may be sociable, having many contacts with others, while in another clique he/she may be more taciturn. such contact behaviors have also been seen in opportunistic social networks, where people are more frequently to contact their family or friends, while they meet accidentally with strangers [24] . if one tried to characterize such a network by statistics of the mean number of contacts a person has, one would be missing the features of the network, such as the dynamics of epidemic, resulting in a biased understanding of the epidemic spreading process. as shown in fig. 1 , suppose an infectious disease occurs in a community c 1 , and unfortunately, alice is infected. in order to delay the epidemic spreading, bob should be protected first, because of his close contact to alice and other people. in this situation, although carl has a high social status in the whole network, the infectious disease would break out in the community and then spread to the entire network if he was immunized first. to this end, we investigate the evolution of community structure in opportunistic social networks, and analyze the effect of community-based immunization strategy on epidemic spreading. we make the following contributions. we find that the spreading speed of epidemic within one community is faster than that across different communities. this result is encouraging as it indicates that the outbreak of epidemic could be delayed, if one could further break down the osn traces into lots of small communities by removing some special nodes. we observe that the most efficient immunization strategy on epidemic spreading is to remove nodes with high local importance in communities. more interestingly, we find that high local importance but non-central nodes contribute more to epidemic spreading process, leading us to conjecture that it is not ''the more central, the better'' for the implementation of control strategy. we study the role of nodes' local importance in epidemic spreading, experimentally and analytically. we do so not only by excluding nodes with high local importance from osn traces but also by developing an analytic model which formally characterizes the relationship between nodes' local importance and the community cohesion. we find that the community cohesion is heavily dependent on local importance of nodes. removing locally important nodes sharply lowers the community cohesion, and thus helps to suppress the epidemic. we organize the remainder of this paper as follows. section 2 reviews related works. section 3 introduces the osn traces and network model. the next two sections present our solutions to evaluate node's local importance and cluster nodes, respectively. we analyze the effect of community-based immunization on epidemic spreading in section 6. finally, in section 7 we conclude our paper. immunization strategies in general can be classified into two categories: the ring strategy [13] and targeted strategy [14] [15] [16] [17] [18] . the targeted immunization strategy, in which nodes playing an important role in the network are removed first, has shown to be very effective [16] . pastor-satorras et al. [14] first studied the targeted immunization strategy and found that immunizing nodes with strong connectivity is more effective than that of randomly selected nodes. holme et al. considered a more challenging scenario, where only neighborhood information of nodes can be used. they observed that the most efficient strategy is to iteratively immunize the neighbor of nodes with big out-degree [15] . subsequently, zhang et al. [17] developed a more precise model by taking the immunization willingness of individuals into account. in addition, schneider [18] tested the role of node's betweenness centrality in epidemic spreading, and obtained the similar result. recently, the concept of node importance has been introduced to the fields of routing and message diffusion in opportunistic social networks. for example, the authors of refs. [25, 12, 26] exploited the node importance to make routing decisions. they found that forwarding messages to nodes with high centrality could increase the message delivery ratio. similarly, the authors of refs. [21, 22] observed that nodes wandering from one community to another (such nodes thus have a high contact frequency with others in the network) contributed more to message diffusion. all of the above works focus on the central nodes in a network, they evaluated node's importance either by logical centrality metric or by physical contact behavior among nodes. our work supplements the previous results, exploring the role [4, 5] , multicasting [27] and location of rumor source [28] . we use real and synthetic traces in this study, both of them have their own advantages and can be complementary to each other. the former helps to observe the real epidemic spreading behavior; the latter provides an opportunity to study the dynamics of epidemic spreading in a large scale. the details of each kind of trace are discussed below. real trace (ncsu). the ncsu trace [29] is taken by twenty students who live in a campus dormitory. every week, these students carried garmin gps 60csx handheld receivers, which are waas (wide area augmentation system) capable with a position accuracy of better than three meters 95% of the time, for their daily regular activities, and altogether thirty-five trajectories were gathered from 2006-08-26 to 2006-11-16. the gps receivers perform a device discovery every 10 s to record their current positions. to reduce gps errors, the authors of ref. [29] calibrate a position at every 30 s by averaging three samples over the past thirty-second period. according to the position information in each trajectory, we assume that two nodes have a contact if their distance is less than 150 m, a realistic range for wifi transmissions. synthetical trace (slaw). considering the limitation on scalability of real trace, we need a proper mobility model that can characterize the nature of human mobility, to investigate the dynamics of epidemic spreading, both in width and depth. although many random mobility models, such as random walk and random way point, have been widely used in opportunistic social networks for evaluating routing performance or even the epidemic dynamics [30, 31] , they cannot reflect the main features of human mobility, including the truncated power-law flights and pause-times, the heterogeneously bounded mobility areas of different nodes, etc. the recent work [32] proposed a new mobility model called slaw (self-similar least action walk) that can produce synthetical trace incorporating various features of human mobility. we therefore use it to produce synthetical human traces for investigation on epidemic spreading. the simulation area is 2000 m × 2000 m 2 , the number of nodes is varying from 100 to 500 with a step 100. table 1 summarizes all slaw model parameters (for detail meanings of these parameters, please refer to ref. [32] ). traditional methods to model opportunistic social network mainly include time expanded graph and binary graph. the time expanded graph catches each snapshot of the original network, that is, new edges connecting a node and its copy are added at the next snapshot with the edges having been existed in the last snapshot. it hence incurs to the scalability issue [33] . on the other hand, the binary graph can alleviate the storage overhead. it however neglects the duration of each contact and its decayed age. this method only characterizes the time-varying network at a coarse-grained level [12] . considering these facts, we model an osn as a decayed aggregation graph dag = (v , e), where v denotes the set of nodes (|v | = n) and e denotes the set of edges. let w (t) = (w uv (t)) n×n denote its adjacency matrix and n uv (t) = {(on i , off i ), i = 1, 2, . . . , n} denote the contact series between nodes u and v in the interval [0, t], where the tuple (on i , off i ) denotes the start moment and end moment of the ith contact respectively, and n is the number of contacts. we formulate the contact strength between nodes (i.e., the value of w uv (t)) as a decayed sum problem [34] . decayed sum problem includes two components. the first one is weighted function f (i), and the second one is decayed function g(t − off i ), as shown in the following equation. definition 1 (decayed sum). given the contact series n uv (t), the goal is to estimate the decayed sum at any current time t where f (i) = off i − on i denotes the ith contact duration (i.e., the weighted part of decayed sum problem) and g(t − off i ) denotes the decayed part. we set g(t − off i ) = e −(t −off i ) as the inter-contact time between nodes generally obeys an exponential decay in osn [35] . hence, eq. (1) can be reformulated as (2) we next analyze the space complexity of dag. exact tracking of w uv (t ) needs θ(n) storage bits. considering scalability issue (in general, n ≫ n), we should further reduce the storage overhead while keeping the same calculation precision. let from theorem 1, each node only carries a single counter to exactly track the contact strength between itself and any other node, which forms the row vector w u of matrix w . we use this matrix to cluster nodes in the next section. this paper mainly concentrates on the local importance of nodes and its effect on epidemic spreading. as discussed in sections 1 and 2, the local importance of nodes reflects their social status in a community, rather than in the whole network. 1 traditional solutions for evaluating node importance mainly include the node degree, closeness and betweenness. all of them are not applicable, due to the unknown number of neighbors (for degree measure) and vulnerable end-to-end path (for closeness and betweenness measures) in opportunistic social networks. for example, if we use the betweenness to measure node importance, we first need to collect the shortest paths for each node pairs in an offline way, and then count the number of times that each node appears in these shortest paths. furthermore, the three methods have a bias towards a global measure of nodes. to deal with these issues, we use the technology of principal component analysis (pca) [36] to evaluate node's local importance, which provides an online method for evaluating node importance. principal component analysis is a powerful tool to extract relevant information from a data set by filtering noise and redundant data. this relevant information reveals the hidden, simplified structures underlying the data set. we generalize the principle of pca as follows. suppose that a node u has built the matrix w (please refer to section 3.2), and the matrix w has been centralized (i.e., subtract the corresponding mean from each column). let c w = w t w /(n − 1) denote the covariance matrix of w . let us further diagonalize the c w as where λ = diag(1, 2, . . . , n) and p is a normalized orthogonal matrix. let x i be the eigenvectors of c w and λ i the corresponding eigenvalues, and λ 1 ≥ λ 2 ≥ · · · λ n . we can see from fig. 2 that the row vector α u (α u1 , α u2 , . . . , α un ) fig. 2 . the spectral space of w and its vector representation. the main notations used in the paper. notation explanation w u the row vector of matrix w c w the covariance matrix of w p k+1 the noise components of w p k the principal components of w p the eigenvector decomposition of c w w k the dimensionality reduction matrix of w the distribution of node u in the n-dimensional spectral space the noise distribution of α u denotes the distribution of node u in the n-dimensional spectral space, and the column vector x i (α 1i , α 2i , . . . , α ni ) denotes the coordinates of all of the nodes in the ith dimension of the spectral space. in addition, once we get the orthogonal matrix p, we generally select the top k-dimensional spectral space (x 1 , x 2 , . . . , x k ) as the principal component of w , since the corresponding top k eigenvalues dominate the spectral graph features [37] . algorithm 1 describes the above computation process and table 2 lists the main notations used in the paper. mathematically, let λ k denote the diag(1, 2, . . . , k) and the matrix p k = (x 1 , x 2 , . . . , x k ). let α + u represent (|α u1 | , |α u2 | , . . . , |α ui | , . . . , |α uk |), where |α ui | denotes the absolute value of α ui , we have lemma 1. for a given decayed aggregation graph dag with k communities, the matrix p k is the projection matrix, elements of the vector α + u are the projected values of node u in such k communities. proof. let w k denote the dimensionality reduction matrix of w and the matrix c w k be the covariance matrix of w k . based on the theory of pca, c w k should been diagonalized as well, we have on the other hand, from eq. (4), we get replace λ k with eq. (5) and c w with w t w /(n − 1), respectively, we have multiply both sides by (n − 1) and use the substitution of p t hence, we conclude that the matrix p k is the projection matrix. let c i denote the principal direction of the ith eigenvector x i . based on the singular value decomposition (svd) of w k [38] , both c i and x i are satisfying: after some algebra, we obtain x i = w t k c i /λ proof. from lemma 1, we know that the projection length of node u in community i is |α ui |, and from the spectral graph theory [37] , it has been shown that the eigenvalue λ i indicates the strength of community i in a graph. hence, we get obviously, the l i u is mathematically equivalent to |α ui | if we ignore the factor λ i (considering the fact that local importance of each node in community i has the common factor λ i ). we specifically use the above equation to denote node's local importance, this is mainly because the product of the two parts (|α ui | and λ i ) has a special physical significance, it reflects the contribution of community i to node u's global importance g u , that is, with the above two equations, 2 we evaluate the local and global importance of each node, and plot their empirical distributions in fig. 3 , where the subgraphs correspond to the case in which the local importance of nodes is measured with respect to the largest community ( fig. 3(a) ), the second ( fig. 3(b) ), the third (fig. 3(c) ) and the fourth largest community (fig. 3(d) ), respectively. we observe that, for most nodes, the global importance shows a strong correlation with the local importance. furthermore, the correlation decreases with decreasing community size, as small communities play a weak role in a graph. another interesting observation is that the two social metrics of nodes have different increasing rates, which result in some central nodes having a relatively low importance in a community, and vice versa. in section 6, we study their effects on epidemic spreading. cutting a graph into small clusters has been studied widely. we use the k-means, one of the most well-known clustering algorithms [39] , to detect the temporal community structure. the advantage of the k-means algorithm compared to other methods such as cnm [40] and k-clique [41] is that it does not need to know the neighbor relationship between nodes, it only requires the adjacent matrix of a weighted graph such as the dag, while the cnm and k-clique are more appropriate to a binary graph. in addition, based on the technology of pca discussed above, it is confident to determine the number of communities, the initial elements for each community and the termination condition, three issues strongly affecting the performance of k-means. we next discuss how to detect the community structure based on the refined k-means. (1) determining k, the number of communities: pca provides a roadmap to reduce a confusing data set to a lower dimension that retains the main features of the original data set. the rationale behind this is that the eigenvalues of a network, play a big role in many important graph features. it has been shown that the maximum degree, clique number, and even the randomness of a graph are all related to λ 1 . in general, we select the top k eigenvectors to denote the main structures of the graph, where the value of k satisfies in this paper, we set r = 0.85, an experiential value 3 belonging to the default interval [0.7, 0.9] [37] . (2) excluding the noise nodes: in opportunistic social networks, there commonly exist some nodes with few contacts to other nodes. we call them noise nodes in this study. excluding the noise nodes has little effect on epidemic spreading speed. furthermore, it helps to reduce the problem size and algorithm complexity. we now discuss how to use pca to identify the noise nodes. pca divides a network into two different parts: (1) the principal components p k , and (2) the opposite p k+1 , where the p k+1 = (x k+1 , x k+2 , . . . , x n ), as shown in fig. 2 . we call the latter noise components of the network. accordingly, we divide the row vector α u by α 1,k u (α u1 , α u2 , . . . , α uk ) and α k+1,n u (α u,k+1 , α u,k+2 , . . . , α un ), the signal and noise of the node u. from the theory of pca, if node u is dominated by its noise components, that is, α u is dominated by the α k+1,n u , we can exclude this node from the graph. we use signal-to-noise ratio to identify which component dominates a node. . the snr is the ratio of signal energy over that of noise. from theorem 2, we know that the node u's local importance relative to community i is |α ui | λ i , which is also the amplitude of node u's signal in the ith dimensional spectral space. hence, the signal energy e u signal of node u can be presented as e u signal =  i∈ [1,k] (λ i |α ui |) 2 =  i∈ [1,k] (λ i α ui ) 2 , and the noise strength e u noise is equal to  j∈[k+1,n] (λ j α uj ) 2 . based on definition 2, we call node u a noise node if its snr u satisfies snr u < 1. (3) determining the initial elements for each community: after we have ascertained the number of communities and excluded the noise nodes, the next step is to determine the initial centroid m i (i = 1, 2, . . . , k) for each community c i . we select the node u, s.t. max |α ui | (u = 1, 2, . . . , n) for each eigenvector x i , as the initial node of community i, and set m i = α u . algorithm 2 describes this procedure. v ← 1 {tracking who is the maximum} 6: for u = 2 to n do 7: if |α ui | > maxvalue ∧ u is not a noise node then (11) where n i is the number of nodes belonging to c i . k-means is characterized by minimizing the sum of squared errors, it has been shown that the standard iterative method to k-means suffers seriously from the local minima problem, because of the greedy nature of the update strategy. fortunately, theorem 3 guarantees the pca-based k-means is immune to this problem. ref. [42] ). minimizing j is equivalent to maximizing trace(p t c w p) (please refer to eq. (19) of ref. [42] ), and max trace(p t c w p) = λ 1 + λ 2 + · · · + λ k . in other words, the pca-based k-means has reached the optimal performance once we cluster all of the non-noise nodes for the first time. (5) clustering nodes: for any node u, we compute the distance between itself and the centroid m i , dist(α u , m i ), and select i, s.t. min dist(α u , m i ) (i = 1, 2, . . . , k) as the community node u belongs to, where, dist(α u , m i ) = θ (u, i) = arccos α u m i t ∥α u ∥ 2 ∥m i ∥ 2 and θ(u, i) denotes the angle between α u and m i . after node u joins the community i, we update the centroid m i by eq. (11) so as to select the next node. algorithm 3 describes the clustering procedure. updating m i 8: end for 6. results and analysis we define the temporal community structure as a series of snapshots of communities underlying the traces. we take a snapshot every 120 s for the communities. compared to the five hours duration of experiment, the snapshot interval is chosen to be relatively small so as to obtain a detailed view of the community evolution and to make an unbiased understanding of epidemic spreading as much as possible. fig. 4 plots the number of communities hidden behind the traces at different snapshots, where the term ''s(number)'' denotes the slaw trace with different number of nodes. we observe that the topology is volatile over time. at ncsu, the number of communities varies from 4 to 10 with a mean of 7.3. the number of communities at s(100) varies between 8 and 16 with a mean of 11.7. table 4 summarizes the statistics of community structure for all the traces. fig. 5 shows size of the top 4 communities at the slaw trace with 500 nodes. we find that each community is not stable over time as well. the size of the largest community varies between 13% and 35% during the experiment, and 11%-20% of the nodes belong to the second largest community. the third and fourth largest community are much closer, varying from 9% to 17% and from 8% to 15%, respectively. in summary, the top 4 communities cover almost 60% nodes. other smaller communities share the rest nodes. these results suggest that nodes in opportunistic social networks do not belong to a single, stable community. instead, the network is made of many temporal clusters. we analyze their effects on epidemic spreading in the next section. having shown that the temporal communities are built on node's social contacts, it is significant to understand the role of these communities in epidemic spreading. to this end, we record the epidemic spreading time within one community and that across different communities. table 3 summarizes the results. we find that the spreading speed of epidemic within one community is faster than that from one community to another. at ncsu, the mean spreading time within one community is 19 min, and 45 min between communities. the slaw traces show similar phenomena, especially at s(300), where the inter-community spreading time is almost four times of that of intra-community. this is mainly because there exist many small communities at this scenario (as shown in table 4 , the s(300) trace has the most number of communities and the community structure changes dramatically). the small communities are more effective to refrain the epidemic spreading than the big ones. this result is encouraging as it indicates that the outbreak of epidemic could be delayed, if one could break down the osn traces into lots of small communities by removing some special nodes. previous work has suggested that removing central nodes is an effective way to delay the epidemic outbreak. this conclusion is somewhat inconsistent with our aforementioned results, since some central nodes have relatively low importance in communities and removing them does little damage to the community structure. therefore, we conjecture that it may be inefficient to suppress the epidemic spreading by removing central nodes. to validate this, we classify nodes into different categories according to their global and local importance. specifically, we select as high local importance nodes (hot) with the top 10% nodes that have the highest local importance with respect to a community, and the rest as low local importance nodes (lot). in addition, we define a central node as a node that belongs to the top 10% nodes with the highest importance in the whole network, the remaining nodes are called non-central nodes (similar selection/definition has been used in ref. [43] ). our basic idea here is to understand the role of each kind of node in epidemic spreading. we first calculate the epidemic spreading time for each trace including all nodes. we then repeat the same experiment by removing each of the four node categories (we remove the same amount of nodes for each category in order to make a fair comparison). fig. 6 presents the results. the y-axis denotes the immunization efficiency compared to the base case (the case including all nodes), i.e., higher bar means higher efficiency. the first and counter-intuitive phenomenon is that hot nodes, instead of the central, play a big role in epidemic spreading (as shown in fig. 6(a) ). compared to removing the central nodes, the immunization efficiency increases 50% on average when the hot nodes are removed. more interestingly, we observe that non-central hot nodes are responsible for most of the epidemic spreading in opportunistic social networks ( fig. 6(b) and (c) ). removing them improves the immunization efficiency by 25%-150% at all traces. in contrast, removing central lot nodes shows a more limited improvement. this phenomenon experimentally validates that it is not ''the more central, the better'' for the implementation of control strategy. we next explore the reason behind this phenomenon. section 6.2 indicates that the spreading speed of epidemic heavily depends on the temporal communities. as a result, even though hot nodes have on average lower global importance than the central, they do great damage to the community structure when removed, and thus help to suppress the epidemic. the goal of this section is to formally characterize the relationship between the cohesive community and node's importance. we generally use the community density to denote its cohesion. let d(c i ) represent density of community i, we have the following theorem (see appendix for proof). we use this equation to evaluate the impact of removing nodes on community density, and plot the changing of community density in fig. 7 , where the y -axis denotes the ratio of community density after some nodes are removed from a community over the initial density of that community. we find that community density is heavily dependent on node's importance. however, there exists a large difference of impact between the local and global importance of nodes. removing in rank order the most important to the least nodes in a community leads to a faster decline in community cohesion. in contrast, removing first the central nodes will shrink the community but with a slower speed. taken together, hot nodes appear to be crucial for implementing the immunization strategy, because of their large impact on community structure when removed. in this paper, we improve our understanding of immunization strategy on epidemic spreading in opportunistic social networks. we observe that a temporal community structure helps to control the epidemic spreading. this phenomenon is encouraging as it indicates that the outbreak of epidemic could be delayed, if we could further break down the osn traces into lots of small communities by removing some special nodes. motivated by this observation, we separate nodes into different behavioral classes from a community viewpoint. we show that hot nodes can remarkably suppress the epidemic spreading when removed. more interestingly, we find that non-central hot nodes are responsible for most of the epidemic spreading. these results reveal a counter-intuitive conclusion: it is not ''the more central, the better'' for the implementation of control strategy. for any t ∈ t 2 , since t ̸ = off i (note that off i ∈ t 1 and t 1 ∩ t 2 ≡ ∅), we have h(t) = 0. hence, = h(t ) + e −1 w uv (t − 1). we first give the following lemma. proof. from the clustering process mentioned above, we know that the centroid m i (m 1i , m 2i , . . . , m ni ) can approximately represent the line formed by nodes within the ith community (please refer to eq. (11) p. 7). on the other hand, the virtual centroid vector m i should be close to eigenvector x i . this is mainly because m i ≈m i =   u⊂c i α ui  /n i , as α ui is the dominant part of α u . hence,m i locates in the line formed by the eigenvector x i . we get the conclusion as different eigenvectors are linearly independent. we now prove eq. (9). let variable e u denote the event measuring global importance of node u (i.e., g u ) in the whole network. let variable e i u denote the event that measures node u's local importance in a community i. we have p(e u ) = p(measuring g u in the whole network) = p(measuring g u across all communities) p(e i u )/ * from the lemma 2 * /. that is, measuring node u's global importance is equal to first measuring its local importance in different communities, and then put all the components together. proof of theorem 4. consider the division of an unweighted graph u into k non-overlapped communities c 1 , c 2 , . . . , c k . let v i = (v 1i , v 2i , . . . , v ni ) be the index vector of community c i , and v ui is equal to 1 if node u belongs to c i and 0 otherwise. for community c i , its density can be expressed as d(c i ) = number of edges in c i number of nodes in c i = v t dtn: an architectural retrospective opportunities in opportunistic computing pocket switched networks and human mobility in conference environments socially-aware routin for publish-subscribe in delay-tolerant mobile ad hoc networks supporting cooperative caching in disruption tolerant networks data delivery properties of human contact networks impact of human mobility on opportunistic forwarding algorithms exploiting social interactions in mobile systems small-world behavior in time-varying graphs a reaction-diffusion model for epidemic routing in sparsely connected manets networks of strong ties bubble rap: social-based forwarding in delay-tolerant networks ring vaccination immunization of complex networks efficient local strategies for vaccination and network attack finding a better immunization strategy hub nodes inhibit the outbreak of epidemic under voluntary vaccination suppressing epidemics with a limited amount of immunization units centrality in social networks conceptual clarification tearing down the internet overlapping communities in dynamic networks: their detection and mobile applications proceedings of the thirteenth acm international symposium on mobile ad hoc networking and computing finding community structure in networks using the eigenvectors of matrices impact of strangers on opportunistic routing performance social network analysis for routing in disconnected delay-tolerant manets 2010 proceedings ieee infocom multicasting in delay tolerant networks: a social network perspective finding rumor sources on random graphs on the levy-walk nature of human mobility efficient routing in intermittently connected mobile networks: the multiple-copy case performance modeling of epidemic routing slaw: self-similar least-action human walk time-aggregated graphs for modeling spatio-temporal networks maintaining time-decaying stream aggregates power law and exponential decay of intercontact times between mobile devices principal component analysis spectral graph theory community detection in graphs finding community structure in very large networks uncovering the overlapping community structure of complex networks in nature and society he, k -means clustering via principal component analysis inferring social ties across heterogenous networks matrix perturbation theory we acknowledge the support of the national natural science foundation of china under grant nos. u1404602, u1304607, the science and technology foundation of henan educational committee under grant nos. 14a520031, 14a520068. we also wish to thank the crawdad archive project for making the dtns traces available to research community. proof of theorem 1. let us split the interval [0, t ] into two disjoined parts t 1 and t 2 , where key: cord-007749-lt9is0is authors: preston, nicholas d.; daszak, peter; colwell, rita r. title: the human environment interface: applying ecosystem concepts to health date: 2013-05-01 journal: one health: the human-animal-environment interfaces in emerging infectious diseases doi: 10.1007/82_2013_317 sha: doc_id: 7749 cord_uid: lt9is0is one health approaches have tended to focus on closer collaboration among veterinarians and medical professionals, but remain unclear about how ecological approaches could be applied or how they might benefit public health and disease control. in this chapter, we review ecological concepts, and discuss their relevance to health, with an emphasis on emerging infectious diseases (eids). despite the fact that most eids originate in wildlife, few studies account for the population, community, or ecosystem ecology of the host, reservoir, or vector. the dimensions of ecological approaches to public health that we propose in this chapter are, in essence, networks of population dynamics, community structure, and ecosystem matrices incorporating concepts of complexity, resilience, and biogeochemical processes. definitions of one health have varied among different authors and institutions, but a defining central tenet is that a one health approach brings a holistic understanding of health. this broader view includes human medicine, veterinary medicine, and an understanding of the ecological context of health (which we call 'ecohealth'). to date, one health approaches have tended to focus on closer collaboration among veterinarians and medical professionals, but remain unclear about how ecological approaches could be applied or how they might benefit public health and disease control. in this chapter, we review ecological concepts, and discuss their relevance to health, with an emphasis on infectious diseases, notably emerging infectious diseases (eids). nearly two-thirds of eids are zoonotic, and a majority of those (72 %) originate in wildlife (anderson et al. 2004; cleaveland et al. 2001; daszak 2000) . diseases are considered 'emerging' if they are identified as occurring in a new geographic area, expanding their incidence rapidly, displaying novel genetic code, or moving into humans for the first time. the most important are pandemics, those that become established in humans and spread internationally. pandemics tend to be zoonotic, foodborne, or antimicrobial resistant pathogens, and their emergence and spread is overwhelmingly a result of changes in human demography (e.g. travel, population growth), behavior (e.g. drug use), economic activity (e.g. agricultural intensification), or anthropogenic changes to the environment (e.g. land-use change, climate change) (weiss and mcmichael 2004; jones et al. 2008) . the interactions among these underlying drivers and the dynamics of pathogens in wildlife, livestock, and people are a key focus of studies of the ecology of infectious diseases. ecology emerged from natural history and rose to prominence as a scientific discipline in the late nineteenth century as the 'study of the interactions of organisms with their environment' (haeckel 1869) . while originally a descriptive science, the theories of adaptation, evolution, and speciation rapidly became central to the field, and led to increasingly analytical approaches (lawton 1999) . over the past few decades, ecologists have analyzed data from field observations, laboratory studies, and large-scale field experiments to describe the structure and dynamics of populations, their interactions within communities, and the complexity of ecosystems. in this chapter, we build on the work of wilcox and jessop (2010) and last (1998) , adding an ecosystem network perspective to describe how ecological approaches can be focused on infectious diseases. we focus on three components: population, community, and ecosystem ecology. population ecology is the study of the population dynamics of a species with relevant metrics of density, natality, mortality, immigration, and emigration (hall 1988; murray 1999) . population dynamics are generated through competition, predation, parasitism, and the distribution of species. community ecology describes the clustering of populations of species into communities and the processes that dictate composition and diversity. pertinent community metrics are similarity, continuity, species, and genetic diversity. ecosystem ecology is the study of biotic and abiotic components of ecological systems, their biophysical interactions, and the flow of energy and materials (lindeman 1942; odum 1969; cook 1977) . the metrics for ecosystems include state, rates, and productivity. ecosystems provide the framework for organization of species and resource compartments, and modulate rates and dynamics of functions, processes, and services. in modern ecological approaches, a network perspective can be used to describe interactions among ecosystem components, with populations referred to as nodes, links between nodes in a community as edges, and the overall environment and abiotic components as an ecosystem matrix (fig. 1) . this framework complements a shift in ecosystem thinking from structures and hierarchies, to networks and webs. while the concepts in this chapter are presented in the context of wildlife and emerging infectious diseases, they are generalizable to diverse ecosystem interactions. traditional views of ecosystems were focused on the concept of directional succession, whereby ecosystems developed along a predictable pathway to a climax system (e.g. mature deciduous forest) (clements 1916; gleason 1939) . in reality, ecosystems are dynamic and complex aggregations of communities continually adapting to internal and external influences. rarely are they stable or at fig. 1 diagram illustrating the ecosystem components described in the text: a node is a population of organisms; edges are links between nodes in a community; and the overall environment including abiotic components is the ecosystem matrix. nodes are structured vertically into trophic levels and horizontally along an environmental gradient equilibrium, as described by static representations of food chains, trophic guilds, and species dominance. moreover, they demonstrate non-equilibrium dynamics in a mosaic of patches shifting among stable states when disturbed. the complex structure of ecosystems has long frustrated efforts to forecast and predict their behavior, yielding models of resilience, complexity, and chaos. 3 ecosystems: abundance, structure, and flow historically, public health has focused on the dynamics and structure of human populations-only a single node within the context of global ecosystems. holistically, human health can best be considered in the context of other organisms within a network of populations, communities, and ecosystem interactions. infectious diseases within a one health context require an additional dimension, namely the natural environment as the habitat of the disease agents themselves, examples of which include water borne diseases. population ecology focuses on the dynamics of an individual species in a defined area, where the malthusian growth model is a central theory. however, wildlife populations are not static, nor is their growth linear. moreover, they display complex cycles and populations evolve from interactions, including competition, predation, herbivory, and mutualism, while demonstrating stochastic dynamics and lagged responses to disturbance. because knowledge of wildlife populations still is incomplete, there are many species for which historic data are lacking or routine monitoring not yet possible. furthermore, coverage varies across geographic regions, taxonomic groups, size, abundance, and economic or social values. despite the fact that most eids originate in wildlife, few studies account for the population dynamics of the host, reservoir, or vector, in contrast to studies of human populations and demographics. this uncertainty concerning wildlife health presents a threat both to domestic animals and human populations. at a minimum, those infectious disease agents closely linked to human health should be identified and subjected to intense study, e.g., those that incubate and spread disease or provide ecological services such as disease regulation and/or vaccine discovery. identifying these key species helps set priorities for routine surveillance, as well as uncovering as yet unknown species that present a threat or cure. fluctuations in host and vector abundance engender a variable risk distribution for disease transmission. some species are unique in their proximity to human physiology (e.g. primates and wild pigs) or in their expansive ranges (e.g. birds and bats), posing unique threat as integrators, spreaders, and laboratories for recombination and mutation of disease pathogens (daszak 2000) . wildlife population ecology can be employed to improve global health models, but within limitation. populations are difficult to define and species-based definitions are generally inadequate. those that are naturally or artificially isolated often exhibit distinct behaviors and present differential risks (levins 1968). populations are a continuum, where factors such as age, sex, and size can influence risk of disease transmission, especially where distribution of the agent is not uniform. thus, it is simplistic at best to consider population dynamics in isolation from the community structure and ecosystem matrix. community ecology describes an assemblage of nodes and their interactions, or edges. the contributions of individual populations can be characterized by employing network metrics, an example of which would be a high degree of connectivity that identifies critical, keystone nodes influencing the structure of the system. it should be noted that communities can demonstrate both equilibrium and non-equilibrium dynamics. characterizing biodiversity is fundamental to community ecology. it is also one of the more widely reported and popular concepts. biodiversity varies across spatial scales and describes both intraspecific or genetic diversity of a node, as well as diversity of nodes described in terms of richness, abundance, and evenness (bisby 1995; jost 2007; whittaker 1972) . food webs represent a central concept in ecology, being employed to model community structure as complex hierarchies of nodes (lindeman 1942; elton 2001; forbes 1887; hairston et al. 1960 ). inter-node interactions (edges) among consumers and resources form the backbone of food-web networks and the nodes can be structured into trophic levels, or functional groups, such as top predators (borrvall and ebenman 2006; finke and denno 2005) , mesopredators (elmhagen and rushton 2007), herbivores, and primary producers. edges are generally unidirectional, but can flip during the life history of an organism when lower trophic levels prey on juveniles of higher trophic levels. single trophic food webs are the simplest (tilman 1982 ), but few real-world examples exhibit those dynamics, with multi-trophic perspectives more realistic, albeit complex (cohen 1978; deangelis 1992; polis and winemiller 1996) . predator-prey relationships are dominant in representations of the structure of trophic hierarchies, along with the influences of co-evolution, mutualism, autotrophy, herbivory, competition, genetics, and speciation. food webs are structured from top and bottom. top-down control of food webs can occur via predation and resource consumption by consumers, influencing community size structure. at the same time, bottom-up mechanisms operate via abundance, availability, and edibility of primary producers (autotrophs) and secondary producers (herbivores). structural dynamics of a system, i.e., arrangement of nodes and edges, can influence the magnitude and variability of community response to disturbance. endogenous (internal) pressure from one node can reorganize the entire system. food webs are often portrayed with linear connections among trophic levels; however, responses to exogenous (external) disturbance can expose complex nonlinear dynamics and feedback loops. unlike characterizations such as a balance of nature or tree of life, it is apparent from food-web manipulations that ecological networks are complex systems encompassing hierarchies, webs, nested systems, cycles, and flows (carpenter and kitchell 1996; scheffer and carpenter 2003) . when ecology is incorporated into public health endeavors, the scope is frequently limited to distribution and abundance of individual nodes. studying the population dynamics of disease hosts and vectors clearly is important if zoonotic disease emergence is to be understood, but populations need to be studied in the context of edges defining their interactions with other nodes. indeed, a community approach to disease emergence can reveal important nodes and interactions that differ from those identified in population analyses. for example, some nodes, such as keystone species, may be disproportionally important to the system due to strong connectivity or high centrality. superspreaders are highly connected and rapidly disseminate disease through a network. identifying and monitoring the keystone species, superspreaders, and nodes that regulate host and vector abundance is important in disease prevention and control. trophic cascades regulate host abundance when changes at one trophic level cascade through the food web. for example, when a predator population collapses, regulation of the disease is reduced if the disease host or vector is thereby released from control by predation. removing predators directly relieves pressure on prey abundance and may also alter physiological stress, behavior (bakker et al. 2005) , and morphology (werner and peacor 2003) of their prey. clearly, both host and predator require monitoring in such circumstances. inter-species competition affects abundance, evolution, diversity, and pathogenicity of a disease agent. these processes can be tightly coupled to their pathogen hosts and, in turn, the community dynamics of the system. hence, the invasion of an exotic species, triggered by wildlife trade, transportation, or climate change for example, could cause food webs to reorganize thereby altering the probability of disease emergence. on one hand, the introduction of a species like the tiger mosquito (aedes albopictus), which is an aggressive disease vector, can alter the conditional (binary) probability of contracting certain vector-borne diseases. on the other hand, invasions by suboptimal hosts can 'dilute' disease risk. invasions can also introduce boom and bust dynamics, destabilizing systems and tipping native populations into irreversible alternate states. invasive species also diverge genetically from their original populations through isolation and founder effects, contributing to ''waves'' of disease occurrence. spatiotemporal variance in food webs is particularly acute for migratory populations, where resource consumption changes with habitat and the effect on nodes in one system can be transferred to another. in effect, migration provides a unique opportunity for populations and communities to exchange pathogens. in these scenarios, mapping distributed food webs could help identify pathways for disease transmission. food web and community network analyses introduce a high degree of complexity to mathematical and statistical models of systems. furthermore, it is difficult to determine accurately the trophic position of individual nodes in food web models. while advances in stable isotope analysis, fatty acids, and ecological stoichiometry help determine trophic position relative to other nodes in the community, as well as composition of diet; isotopic measurements often have location-specific limitations, whereby values are relative to local autotrophic production in the system as influenced by external subsidies. thus, it is difficult to draw meaningful comparisons among food webs. what is required is a method that generalizes models and captures topological position and functional importance of networks without a food web-specific bias (olff et al. 2009 ). by using food-web manipulations, it has been possible to demonstrate biogeochemical processes play an important role in structuring communities (carpenter and kitchell 1996; scheffer and carpenter 2003) . so, although community ecology considers both nodes and the edges that connect them, these systems must ultimately be studied in the context of their environment or ecosystem matrix. ecosystem ecology encompasses biophysical mechanisms regulating ecosystem metabolism across both biotic and abiotic compartments, this includes ecological function, physiological processes, populations and communities, resource availability, nutrient cycling, and connections among systems. the connections, flows, and cycles affecting the life history of an organism are highlighted, including materials of composition and their life cycle. traversing networks that incorporate abiotic pathways may help map these connections, a useful example of which is the carbon cycle, with biotic and abiotic compartments through which carbon can flow, sequester, or transform. the ecosystem matrix is a spatiotemporal mosaic that provides background structure for ecosystem networks. it is a complex system with unpredictable dynamics, including bidirectional relationships among organisms that extract, modify, and release resources into their surroundings. the physical-chemical conditions that surround an organism regulate metabolism as they consume resources and generate waste (begon et al. 1996) . ultimately, resource flows influence system dynamics of populations and communities. biogeochemistry describes the flow of matter, such as nutrients and toxins, through an ecosystem matrix, including processes such as decomposition and decay. it spans biotic and abiotic compartments through biologically mediated chemical cycling of nutrients. microorganisms play a critical role in the availability of resources by decomposing waste and processing mineral components, essentially driving nutrient cycles in ecosystems. temperature, salinity, ph, and redox generate gradients regulating distribution of organisms and their metabolism, in effect the availability of resources (schlesinger 1991) . availability of resources, notably nutrients, is related to population dynamics, e.g., the life cycle of organisms, and community structure, such as food webs. phosphorus, for example, is a commonly limiting nutrient in freshwater lakes that constrains productivity. while phosphorus can be introduced through external subsidies, the ecological community can influence availability of the resource internally, thereby altering community composition. certain zooplankton, for example, sequester phosphorous for their reproductive needs to the extent that they limit growth and abundance of competing species. these competitive interactions will ultimately affect water quality and physical characteristics, such as transparency and temperature profiles (elser et al. 1998) . physical-chemical conditions of the matrix drive enzymatic processes and affect habitat suitability and niche structure in ecosystems. olff et al. (2009) proposed an additional horizontal ecological-stoichiometry axis to supplement the vertical trophic axis in food webs (fig. 1) . these frameworks build upon research in marine systems (azam et al. 1983 ) and terrestrial systems (bardgett 2005; wardle 2002 ) that emphasize a 'dual foundation' for food webs based on both organotrophs and autotrophs. the landscape provides the physical structure for the ecosystem matrix, including habitat niches for organisms. physical connectivity (e.g., wildlife corridors) can dictate the distribution and dispersal of organisms. as chemicals transition among media such as water, the atmosphere, and land they are modified in ways that alter their availability. landscapes support a mosaic of abiotic conditions that determine the phase space of abiotic resources, including chemical state and suitability for uptake. ecosystem engineering is the process whereby organisms influence the biophysical feedback mechanisms that structure their habitat. this can fundamentally alter ecosystem function from local to global scales (e.g., beaver dams to forest respiration). ecosystem engineers influence the matrix in which they live, rendering it more or less habitable for themselves and their competitors (jones et al. 1994; wright and jones 2006) . in australia, for example, a rabbit fence was built to confine expansion of invasive rabbits, altering patterns of herbivory that, in turn, affected evapotranspiration and regional precipitation. ultimately, this altered the microclimate and suitability of the environment for multiple organisms and processes (lyons et al. 1993) . feedback loops and cycles add complexity and nonlinearity to the system. they can lead to emergence of alternate stable states, with abrupt tipping points, where shifts to alternate regimes modify function and introduce chaos (scheffer and carpenter 2003; carpenter et al. 2008; huisman and weissing 1999; van de koppel et al. 2001 rietkerk 2004 ). ecosystem processes influence human health directly via interaction with toxins and nutrients, and indirectly via regulation of disease cycles and intensity. bioaccumulation of toxins throughout food webs poses a health threat, an example of which is dichlorodiphenyltrichloroethane (ddt), effective in controlling disease vectors but endangering animal and human health by its bioconcentration. ecosystems provide services such as sequestering toxins in wetlands and sediments, but these processes often are fragile and their disruption results in system-wide impacts. nutrient enrichment, or eutrophication, of lakes has been directly correlated with prevalence of aquatic disease agents (johnson and carpenter 2008) . regulation of disease is an indirect ecosystem service. however, perturbations of ecological systems can alter the regulatory process and unleash novel pathogens, demonstrated vividly by lyme disease and the dilution effect (ostfeld and keesing 2000) . in today's world, the biosphere is undergoing unprecedented anthropogenic ecosystem engineering, ranging from land conversion to ecological simplification and extensive biogeochemical change. the impact of these alterations spans ecosystem nodes, edges, and pathways with profound ramifications for ecosystem services and resilience. as the modified ecosystems and regimes emerge, their potential to impact human health must be understood. investigators have developed hotspot maps to characterize risk of disease emergence (jones et al. 2008 ) and threats to biodiversity (mittermeier et al. 1999 ). however, coupled socio-ecological models of risk have yet to be developed. as a network evolves, dynamic risk mandates continuous adaptive iterations to monitor emerging threats. the major drivers are direct anthropogenic land-use change, e.g., deforestation, agricultural expansion, habitat destruction, and complex indirect feedback from anthropogenic impact affecting biogeochemical cycles, e.g., nutrient cycles and climate change. the phase space for ecosystems evolves as communities are restructured. emerging systems are unstable and exhibit complex non-equilibrium dynamics and alternate states. getting ahead of an epidemic curve (fig. 2 ) requires more than simply aggregating concepts of populations, communities, or ecosystems (schoener 1986). the changing network properties of the system must be monitored, along with indicators of resilience and leading indicators of collapse, if how a major disturbance is propagated or dampened through the system is to be understood. failing to comprehend the emerging topology of coupled socio-ecological systems presents a challenge of knightian uncertainty, where risk is immeasurable, and panarchy, where cause and effect are disproportionate. in these instances, disturbances can become amplified through emerging network dynamics. changes like habitat destruction and land-use/land-cover change affect the physical structure of the environmental matrix and have profound impacts on ecosystems. they jeopardize critical services, e.g., disease regulation and other, as yet unknown, ecosystem services. for example, minor disturbances from deforestation in the peruvian amazon exposed frontier effects, whereby cases of infectious disease peaked with human encroachment, but re-stabilized as humans and pathogens adapted (olson 2010) . it is difficult to anticipate consequences of ecosystem encroachment since the dynamics are highly variable and outcomes unpredictable. however, in this case the system exhibited altered contact and transmission rates, as well as improved habitat for malaria vectors. genetic diversity dictates adaptability. we should anticipate widespread physiological, morphological, and behavioral adaptations with land-use change, and inevitable consequences for disease emergence. geography and landscapes have long been known to play a critical role in disease, indeed the earliest disease maps by finke and humboldt date from the early victorian period (tylianakis et al. 2007 ). hence, we can anticipate that landscape changes will fundamentally alter existing ecosystem networks. changes at the landscape level, such as isolation due to habitat fragmentation, counter the trend of more highly connected systems. however, an increase in isolated systems may lead to increased genetic drift and introduce new vulnerabilities from founder effects and genetic bottlenecks. these refugia and biological corridors become hotspots for disease transmission as organisms are crowded out of the human landscape and stressed by reduced resource availability. the green revolution brought widespread alterations to global biogeochemistry. accompanying changes in agricultural practice altered the agrarian landscape-an important habitat in terms of both surface area and productivity. in this context, biogeochemistry is particularly relevant to health, given anthropogenic modification of global processes. following world war ii, the industrial efficiencies of bomb factories were adapted to production of agricultural fertilizers. as a consequence, ecological stoichiometry was radically altered. in geological time, this is a short-term experiment and it is not yet clear what the long-term implications will be for global-scale ecosystem processes. indeed, the fertilizers manufactured are typically nutrients that limit productivity. hence it is inevitable that these will impact abundance and distribution of organisms, including disease hosts and vectors. in 2004, researchers convened by the wildlife conservation society (wcs) coined the term ''one world-one health,'' at a time of increasing global interest in connections between emerging infectious diseases and environmental stewardship. what has become the one health movement calls for interdisciplinary and crosssectoral approaches to disease prevention, surveillance, monitoring, control, and mitigation, as well as environmental conservation. the goal of improving lives, with integrated health approaches, has been embraced by veterinary, medical, public health, agricultural, and environmental health organizations in the one health initiative. this movement has helped integrate ideas from environmental, veterinary, and agricultural science with public health, and has been successful in bringing broader attention to socio-economic influences on human and animal health. ecohealth emerged in the 1990s from an interest in connecting ecosystems and health through the original work of the international development research council (idrc) (lebel 2003) . the ecohealth community has since grown to include researchers from a broad range of disciplines, all of whom share an interest in the intersection of ecology and health. humans must be included in ecohealth models and wildlife in one health models. otherwise, our understanding of disease risk cannot be complete. conceptual and mathematical models from the social sciences and public health can usefully be combined with those developed for agriculture and ecology. thus, the coupled socio-ecological models will allow characterization of emerging systems, with the challenge of capturing non-linear complex behaviors. in conclusion, the dimensions of ecological approaches to public health that we propose in this chapter are, in essence, networks of population dynamics, community structure, and ecosystem matrices incorporating concepts of complexity, resilience, and biogeochemical processes. 6 case studies disease emergence can strongly impact the abundance and diversity of wildlife populations. the dynamics of wolf and moose populations on isle royale is a classic case study. the single predator-prey dynamic is unique in its simplicity and is one of the longest studied. the system has never achieved equilibrium and cannot be explained either by top-down control of moose abundance by wolf predation or bottom-up control of wolf abundance by moose availability (vucetich et al. 2011) . moreover, the system exhibits both influences, with episodic disturbances from disease and climate. the introduction of parvovirus by a domestic dog caused the wolf population to crash in 1980. subsequently, the moose population exploded which impacted balsam fir, their winter food. consequently, in 1996 the moose population crashed during a harsh winter. moose are mega-herbivores (owen-smith 1988) that grow sufficiently large to escape predation from wolves, so wolves are only able to prey on the young and infirm. the moose are vulnerable to ticks, which contributes to poor body condition and makes them more vulnerable to wolf predation. ultimately, the dynamics of an invasive disease agent influenced community structure, as did predation, resource availability, parasitism, abiotic conditions, and genetic diversity. these events challenged the certainty of predictive models of population dynamics and community structure. this case study illustrates the difficulty of modeling eids in relation to ecosystem dynamics. correlation of the incidence and intensity of cholera, primarily a waterborne disease, with environmental parameters, e.g., temperature, salinity, nutrients, conductivity, and other factors, including rainfall, extreme weather events, and with access or lack of access of the populace to safe water and sanitation has been studied by many investigators over the past 20 years. the observation of colwell and huq (1994) that the causative agent of cholera, vibrio cholerae, is a commensal of zooplankton, predominantly copepods, led to examination of the annual incidence of cholera in bangladesh. controlling factors were determined to be water temperature and salinity, but also relationship to the annual cycle of plankton (colwell 1996) . the annual bimodal peaks of cholera in bangladesh (spring and fall) correlated with plankton blooms in the spring and fall, with copepods proving to be a vector for v. cholerae (de magny et al. 2008) . further studies, employing satellite remote sensing to monitor chlorophyll, sea surface temperature, and sea surface height in the bay of bengal, provided useful models of the relationship of cholera and climate (lobitz et al. 2000) . refinement of the models and detailed analyses of the river system of the ganges delta led to further and more detailed characterization of the drivers of the spring and fall cholera outbreaks, namely rainfall, river height and flow, and salinity (jutla et al. 2010) . cholera, and very likely other waterborne diseases, can be tracked to their environmental source (jutla et al. 2010) . thus, ecology of the v. cholerae proved to be key in understanding incidence of the disease (colwell et al. 1977; lipp et al. 2002) . based on ecology and evolution of v. cholerae, predicting cholera incidence in various regions of the world is promising. in fact, preliminary results demonstrate effectiveness of regional hydroclimatology combined with satellite data for cholera prediction models for coastal regions in south asia and sub-saharan africa, providing lead time to strengthen intervention efforts before the seasonal outbreaks of cholera occur in these endemic regions. the role of wildlife and livestock in the transmission of infectious agents to humans has been recognized for decades (karesh et al. 2012 ). zoonoses such as rabies remain endemic in wildlife and continue to spillover to people as they have done for probably centuries. however, the importance of wildlife from which pathogens are transmitted has become critical in the era of eids. the majority of eids are zoonotic and originate in wildlife (jones et al. 2008 ). pathogens such as nipah virus (niv), sars coronavirus, and ebola virus originate in wildlife species from tropical or subtropical regions, where human population density is high, and rapid changes to the environment drive increasing risk of spillover. the role of ecology in understanding patterns of zoonotic disease emergence is significant and ecologists need to be integrated into one health efforts. traditional epidemiological investigations of emerging zoonoses focus on the network of human cases affected by an eid, tracing back to origins and examining risk behavior. unfortunately, studies tend to view the role of wildlife as a risk factor for spillover and rarely involve detailed studies of wildlife population dynamics. for example, fruit bats were identified as the reservoir of nipah virus (niv) in malaysia and are, therefore, a risk factor for its emergence elsewhere. in malaysia, niv first emerged in pig farms close to fruit bat habitats. it was hypothesized that the intensive nature of the farms were the trigger for its emergence (chua et al. 2000 ). an alternative hypothesis was that bats brought the virus into the country from nearby sumatra following forest fires there during a severe el nino event (chua et al. 2002) . a collaborative group including wildlife biologists, veterinarians, virologists, mathematical modelers, physicians, and epidemiologists collected and analyzed data on the hunting of bats, pig population dynamics at the index farm, large-scale movement of fruit bats and the capacity of the virus to survive in urine, saliva, and fruit juices (pulliam et al. 2011) . this work was able to demonstrate that the continued presence of bats in the index farm region, and the particular dynamics of intensive production allowed the virus to invade the pig farm, produce a partially immune population of pigs, then re-invade to create a long-term exposure of pig workers, and the large-scale outbreak observed (pulliam et al. 2011) . early epidemiological studies of the emergence of niv in bangladesh identified drinking of date palm sap as a risk factors, and suggested that this might be due to contamination of the collecting pots by fruit bats (luby et al. 2006) . subsequent investigations involved wildlife biologists who used infrared cameras to confirm contamination in the field (khan et al. 2011) , and conducted longitudinal surveillance of bat populations to examine whether seasonal patterns exist that could be used to estimate risk. these studies demonstrate the value of analyzing wildlife reservoir ecology in tandem with epidemiological and specific disease investigations. such an approach will become increasingly important, given the disproportionate rise in eids originating from wildlife over the last few decades (jones et al. 2008) . emerging infectious diseases of plants: pathogen pollution, climate change and agrotechnology drivers the ecological role of water-column microbes in the sea experimental manipulation of predation risk and food quality: effect on grazing behaviour in a central-place foraging herbivore ecology: individuals, populations and communities. blackwell science, oxford bisby fa (1995) characterization of biodiversity early onset of secondary extinctions in ecological communities following the loss of top predators leading indicators of trophic cascades nipah virus: a recently emergent deadly paramyxovirus anthropogenic deforestation, el nino and the emergence of nipah virus in malaysia diseases of humans and their domestic mammals: pathogen characteristics, host range and the risk of emergence plant succession; an analysis of the development of vegetation. carnegie institution of washington, washington cohen je (1978) food webs and niche space environmental reservoir of vibrio cholerae the causative agent of cholera vibrio cholerae, vibrio parahaemolyticus, and other vibrios: occurrence and distribution in chesapeake bay raymond lindeman and the trophic-dynamic concept in ecology emerging infectious diseases: bridging the gap between humans and wildlife environmental signatures associated with cholera epidemics trophic control of mesopredators in terrestrial ecosystems: topdown or bottom-up? stoichiometric constraints on food-web dynamics: a whole-lake experiment on the canadian shield predator diversity and the functioning of ecosystems: the role of intraguild predation in dampening trophic cascades the lake as a microcosm the individualistic concept of the plant association ueber die fossilen medusen der jura-zeit community structure, population control, and competition an assessment of several of the historically most influential theoretical models used in ecology and of the data provided in their support biodiversity of plankton by species oscillations and chaos influence of eutrophication on disease in aquatic ecosystems: patterns, processes, and predictions organisms as ecosystem engineers global trends in emerging infectious diseases partitioning diversity into independent alpha and beta components tracking cholera in coastal regions using satellite observations the ecology of zoonoses: their natural and unnatural histories use of infrared camera to understand bats' access to date palm sap: implications for preventing nipah virus transmission are there general laws in ecology health: an ecosystem approach. international development research centre, ottawa levins, r (1968) evolution in changing environments effects of global climate on infectious disease: the cholera model climate and infectious disease: use of remote sensing for detection of vibrio cholerae by indirect measurement foodborne transmission of nipah virus land-atmosphere interaction in a semiarid region: the bunny fence experiment hotspots: earth's biologically richest and most endangered terrestrial ecoregions. conservation international, cemex sa de cv, agrupaciã³n sierra madre, mexico city murray bg (1999) can the population regulation controversy be buried and forgotten the strategy of ecosystem development parallel ecological networks in ecosystems deforestation and malaria in mã¢ncio lima county biodiversity and disease risk: the case of lyme disease megaherbivores: the influence of very large body size on ecology agricultural intensification, priming for persistence and the emergence of nipah virus: a lethal bat-borne zoonosis self-organized patchiness and catastrophic shifts in ecosystems catastrophic regime shifts in ecosystems: linking theory to observation mechanistic approaches to community ecology: a new reductionism? habitat modification alters the structure of tropical host-parasitoid food webs do alternate stable states occur in natural ecosystems? evidence from a tidal flat scale dependent feedback and regular spatial patterns in young mussel beds predicting prey population dynamics from kill rate, predation rate and predator-prey ratios in three wolf-ungulate systems communities and ecosystems: linking the aboveground and belowground components a review of trait-mediated indirect interactions in ecological communities evolution and measurement of species diversity in: frumkin h (ed) environmental health: from global to local the concept of organisms as ecosystem engineers ten years on: progress, limitations, and challenges acknowledgments we thank alexa frank (ecohealth alliance) and norma brinkley (university of maryland) for invaluable assistance in the preparation of this chapter.the human environment interface key: cord-351785-d35kqobp authors: dewitt, emily; gillespie, rachel; norman-burgdolf, heather; cardarelli, kathryn m.; slone, stacey; gustafson, alison title: rural snap participants and food insecurity: how can communities leverage resources to meet the growing food insecurity status of rural and low-income residents? date: 2020-08-19 journal: int j environ res public health doi: 10.3390/ijerph17176037 sha: doc_id: 351785 cord_uid: d35kqobp the burden of obesity disproportionately influences poor health outcomes in rural communities in the united states. various social and environmental factors contribute to inadequate food access and availability in rural areas, influencing dietary intakes and food insecurity rates. this study aims to identify patterns related to food insecurity and fruit and vegetable consumption within a snap-eligible and low-income, highly obese rural appalachian community. a prospective cohort was implemented to identify gaps in resources addressing obesity and food insecurity challenges. sas 9.4 software was used to examine differences in dietary intakes and shopping practices among snap participants. among participants (n = 152), most reported an annual household income less than usd 20,000 (n = 90, 60.4%), 29.1% reported food insecurity, and 39.5% reported receiving snap benefits within the last month. the overall mean fv intake was 3.46 daily servings (95% ci: 3.06–3.91) among all participants. snap participation was associated with food insecurity (p = 0.007) and those participating in snap were two times more likely to report being food insecure (or = 2.707, 95% ci: 1.317, 5.563), relative to non-participants. these findings further depict the need for intervention, as the burden of food insecurity persists. tailoring health-promoting initiatives to consider rurality and snap participation is vital for sustainable success among these populations. the burden of obesity and related chronic diseases disproportionately affects rural communities in the united states (u.s.) more so than their urban counterparts [1] . theories of social disorganization suggest that the intersection between community structure, such as poverty, socioeconomic status (ses), and residential instability, can result in a void of health promoting culture, infrastructure, and efficacy [2, 3] . previous insights have shown disparaging differences between urban and rural areas on mortality, chronic disease, and screening rates [3, 4] . residents' limited knowledge of health promoting behaviors may lead to poor health literacy and unhealthy lifestyle behaviors, including poor dietary intakes and sedentary physical activity levels [5] [6] [7] . thus, the degree of rurality among geographic areas throughout the u.s. influences the numerous barriers rural communities face and, consequently, their morbidity and mortality rates. among rural populations, myriad factors affect obesity rates, though fruit and vegetable (fv) intakes are of great influence and few u.s. adults are meeting recommended amounts [8] . this is particularly true in rural communities, where adults exhibit higher obesity prevalence and are less likely to meet daily fv recommendations due to various social and environmental factors [1, 9] relative to their urban counterparts. in addition to individual level factors associated with poor dietary intake, rural residents also face greater rates of food insecurity [10] . a depleted or limited food landscape can predispose residents' dietary consumption and shopping patterns thereby further influencing their health status, as diet is a contributing factor in several chronic illnesses [11] . while agriculture and food production are prominent in many rural landscapes across the u.s., it is not the case for all rural communities. rurality does not equate to farmland or local food production, which many would think support food security within these communities. further, the 2017 census of agriculture revealed a decline in number of farms and farmers and in acres of farmland and farmland production [12] . at the local level, there are numerous factors that dictate food production, including geography, terrain, and inadequate resources such as economic hardship or lack of farmers. those who do operate small farms rely on additional off-farm sources for household income [13] . these factors can also influence the household food environment in rural areas. among low income rural populations, the household food environment, including food security and income concerns, are key factors controlling food choice [14] . rural communities continue to face higher rates of food insecurity, compared with their urban counterparts [10] , and food insecurity has been associated with obesity and greater cardiometabolic risk [15] . the supplemental nutrition assistance program (snap) is the largest federally funded nutrition program in the u.s., serving as a household-supporting infrastructure for individuals facing food insecurity. snap assists eligible, low-income individuals and families in need throughout the u.s. [16] . while eligibility varies by state, those whose income and resources fall below certain thresholds are able to supplement their food budgets using snap benefits [16] . thus, snap is often considered a vital resource for those living in rural communities, as the perpetual ses divide continues between rural and urban settings [17] . at the national level, approximately 16% of those living in rural communities live below the federal poverty line, compared with 12% in urban areas [18] . due to these income gaps, snap participation is higher in rural areas, with 16% of households participating, compared with 13% in urban areas [19] . additionally, most recent federal data from 2017 indicate that of those eligible for snap, participation is higher in rural areas (90%) compared to urban areas (82%), and this participation gap continues to climb [20] . rural areas account for 63% of counties in the u.s., and 87% of counties with the highest rates of food insecurity [21] . furthermore, a report from 2018 indicates that 13.3% of those living in rural areas faced food insecurity, compared with 11.5% in urban areas [10] . resources, such as snap benefits, and other programs for those of low ses, are imperative for those in rural communities, as many in these areas are at risk of being food insecure. thus, initiatives like snap can aid in alleviating food insecurity among vulnerable households and improve dietary intakes, when adequate access to nutritious choices are available [22] . community-based efforts have emphasized the importance of looking at social and physical environments when striving to improve food access [23] [24] [25] . therefore, community-based efforts focused on addressing the local food system are necessary to alleviate the barriers related to the procurement of nutritious foods in rural areas. prioritizing engagement with key stakeholders and community members is vital to consider how to best approach food access initiatives in rural communities. conceptually, community-based efforts can be successful in rural communities, as the multifaceted community setting plays a vital role in influencing the food environment and, ultimately, diet choice in these communities. improving health outcomes pose unique challenges, as resources are sparse and healthcare infrastructure is limited; however, modifying or improving the existing food environment encourages nutritious food choices and shopping behaviors. nonetheless, environmental triggers and product availability affect the dietary choices individuals make, influencing overall health and obesity status [26] . given the unique limitations rural communities face, exploring frequented destinations to assess availability can be beneficial to mitigating the barriers that exist [27] . knowing one's food environment, snap participation, and food insecurity status can influence diet quality, an understanding of the interrelationship among these factors can provide guidance for intervention. this study aims to identify patterns related to fv consumption and food access within a snap-eligible and low-income, highly obese rural appalachian county in kentucky. these findings will serve as a baseline to provide context for addressing food insecurity in a remote rural region of the u.s. baseline findings will guide points of intercept, design future programming to explore the impact rurality has on obesity status, and address the barriers related to accessing nutritious foods within this community and those similar. the present study is part of a multi-year high obesity program (hop) project through the centers for disease control and prevention (cdc) to reduce rural obesity prevalence and decrease the risk of chronic disease and preventable mortality. this paper describes one component of the hop project aimed at providing increased geographic or financial access to nutritious foods. efforts to improve food access will address food insecurity. this work was completed by leveraging existing cooperative extension (ces) infrastructure, with an emphasis placed on community partnership and empowerment, thus enforcing action via established community infrastructure. the cdc funding announcement identified eligible counties across the u.s. based on their obesity prevalence. the setting for this funded project was one eligible appalachian county in kentucky with an adult obesity prevalence greater than 40% per the cdc. the appalachian region of the u.s. has continued to experience significant decline in life expectancy [28] , lack of economic development, and stark out-migration, leaving once fervent and thriving communities destitute, impoverished, and struggling to prosper [29] . this community is reflective of the region, experiencing a persistently high rate of poverty and unemployment, low educational attainment, and food insecurity. the cdc's social vulnerability index, comprised of social and economic indicators, designates the county as "highly vulnerable." [30] the county population is approximately 11,200, and declining, with a median household income of usd $35,000 and an estimated 39% of the population living in poverty [31] . the estimated food insecurity rate is 21%, and approximately 31% of households participate in snap [32, 33] . in order to assure broad community input into all program activities, a health coalition was formed, comprised of key stakeholders including local officials (mayor, magistrates), school representatives (food service director, family resource coordinators), library director, concerned citizens, health department representatives, faith-based organization representatives, and community advocates. the health coalition has been pivotal in establishing partnerships to improve health outcomes within the community. it continues to provide input and direction for all aspects of the current project to identify and implement nutrition-related strategies to address the issue of obesity in the county. the current study aims to identify gaps in community resources to establish new partnerships that address obesity and food insecurity challenges. therefore, a formative food system assessment was conducted at baseline to identify potential areas for intervention to enhance healthier food procurement options. figure 1 outlines the community's primary food access points identified through the food systems assessment. findings from the assessment were shared with the coalition to identify potential programmatic efforts to reduce food insecurity within the community. in alignment with the aim of this study, and to complement community efforts, a prospective cohort was enrolled at baseline for a longitudinal study. the prospective cohort study included a face-to-face survey that occurred in year 1 and will again at years 2 and 3. the university of kentucky institutional review board (irb) approved the research, promotional materials, consent forms, and survey instrument. in summer 2019, messages on the county's ces facebook page recruited community residents interested in participating in the cohort study. the ces office, a local food pantry, several faith-based organizations, and grocery stores in the county distributed recruitment materials. furthermore, recruitment occurred through current community programs offered at the ces office. recruitment messaging continued until enough individuals enrolled to meet the required sample size, which allowed for attrition. participants were excluded if they were under 21 years of age, lived outside the county, were non-english speaking, reported plans to move within the next three years, had lived in the county for less than one year, or if they had been diagnosed with cancer. invited study participants completed the survey via a face-to-face meeting. prior to survey administration, interviewers verbally reviewed key points of the consent form with participants, who then reviewed the full consent form independently, and provided an opportunity to ask questions or to decline participation. once deemed eligible, and agreeable to participation, the participant signed the informed consent form and enrolled in the study. a statistical power analysis was performed for sample size estimation and a proposed sample size of 150 adults were recruited to allow for expected attrition. the prospective cohort study surveys were administered at three locations in the county on various days in fall 2019: the ces office, a local food pantry, and the senior citizens center. the initial date of administration had greater turnout than anticipated by study personnel; several surveys were self-administered as a result (n = 24). moving forward, study personnel modified recruitment processes to schedule appointments for each eligible participant to partake in a verbally administered survey. those interested contacted study personnel or the county's ces office to schedule a day and time to participate. this resulted in fewer ineligible participants and complete survey responses. the in alignment with the aim of this study, and to complement community efforts, a prospective cohort was enrolled at baseline for a longitudinal study. the prospective cohort study included a face-to-face survey that occurred in year 1 and will again at years 2 and 3. the university of kentucky institutional review board (irb) approved the research, promotional materials, consent forms, and survey instrument. in summer 2019, messages on the county's ces facebook page recruited community residents interested in participating in the cohort study. the ces office, a local food pantry, several faith-based organizations, and grocery stores in the county distributed recruitment materials. furthermore, recruitment occurred through current community programs offered at the ces office. recruitment messaging continued until enough individuals enrolled to meet the required sample size, which allowed for attrition. participants were excluded if they were under 21 years of age, lived outside the county, were non-english speaking, reported plans to move within the next three years, had lived in the county for less than one year, or if they had been diagnosed with cancer. invited study participants completed the survey via a face-to-face meeting. prior to survey administration, interviewers verbally reviewed key points of the consent form with participants, who then reviewed the full consent form independently, and provided an opportunity to ask questions or to decline participation. once deemed eligible, and agreeable to participation, the participant signed the informed consent form and enrolled in the study. a statistical power analysis was performed for sample size estimation and a proposed sample size of 150 adults were recruited to allow for expected attrition. the prospective cohort study surveys were administered at three locations in the county on various days in fall 2019: the ces office, a local food pantry, and the senior citizens center. the initial date of administration had greater turnout than anticipated by study personnel; several surveys were self-administered as a result (n = 24). moving forward, study personnel modified recruitment processes to schedule appointments for each eligible participant to partake in a verbally administered survey. those interested contacted study personnel or the county's ces office to schedule a day and time to participate. this resulted in fewer ineligible participants and complete survey responses. the administered survey took approximately 45-60 min to complete. participants received a usd $25 incentive to be used a local grocery store as compensation for completing the survey. the survey instrument utilized for this cohort comprised a variety of items to measure fv intake, household environmental measures, food purchasing practices, and demographic characteristics. demographic items in this analysis included age (in years), gender, preferred language, residential status, highest attained education level, race, and annual household income. snap participation was assessed by asking: "in the past month, did you or any member of your household receive snap benefits or food stamps?" response options included 'yes' or 'no'. questions from the national cancer institute (nci) fruit and vegetable intake screener [34, 35] assessed fv intake. the nci screener asks respondents about usual intake of various fv, ranging from never to ≥5 times per day, and portion sizes for every item (e.g., "over the last month, how many times per month, week, or day did you eat fruit?" and "each time you ate fruit, how much did you usually eat?"). items include 100% fruit juice, fruit, lettuce salad, french fries or fried potatoes, other white potatoes, cooked dried beans, other vegetables, tomato sauce, vegetable soup, and the survey instrument utilized for this cohort comprised a variety of items to measure fv intake, household environmental measures, food purchasing practices, and demographic characteristics. demographic items in this analysis included age (in years), gender, preferred language, residential status, highest attained education level, race, and annual household income. snap participation was assessed by asking: "in the past month, did you or any member of your household receive snap benefits or food stamps?" response options included 'yes' or 'no'. questions from the national cancer institute (nci) fruit and vegetable intake screener [34, 35] assessed fv intake. the nci screener asks respondents about usual intake of various fv, ranging from never to ≥5 times per day, and portion sizes for every item (e.g., "over the last month, how many times per month, week, or day did you eat fruit?" and "each time you ate fruit, how much did you usually eat?"). items include 100% fruit juice, fruit, lettuce salad, french fries or fried potatoes, other white potatoes, cooked dried beans, other vegetables, tomato sauce, vegetable soup, and mixtures that included vegetables. summed items created an overall measure of fv intakes among the sample. this measure served as the primary dependent variable for analysis because increased fv intake is a primary goal of the cdc hop project. the secondary dependent variable, food insecurity, was assessed by asking "which of the following statements best describes the amount of food eaten in your household in the last 30 days?"-enough food to eat, sometimes not enough to eat, or often not enough to eat [36] . "sometimes not enough to eat" and "often not enough to eat" were collapsed into "not enough food to eat" to create a dichotomous assessment of food insecurity. potential covariates of interest included gender, income, education, and years of residency. to minimize skewedness, income, education level, and residential status categories were collapsed: income was dichotomized as <usd $20,000/year or ≥usd $20,000/year; education categorized as less than high school degree or high school degree or more; and years of residency was dichotomized into <20 years or ≥20 years. data were entered into redcap (vanderbilt university, nashville, tn, usa) by trained study personnel and were double-checked to minimize data entry errors. data were then exported, and analyses were conducted using sas 9.4 (sas institute, cary, nc, usa). for all analyses, significance was set at p < 0.05. descriptive statistics, including frequencies and medians, were used to characterize survey responses. the nci food frequency scores were calculated using the published algorithms [34] . to test comparisons across groups, wilcoxon rank sum tests were used for continuous measures (age, fv consumption patterns) and chi-square and fishers exact were utilized, as appropriate, for categorical measures. logistic regression models were fit to assess the predictors of food insecurity. since fv servings per day were skewed, the data were log transformed and fit with a generalized linear model. models were adjusted for age, gender, snap participation, residency, and income. table 1 details the characteristics of the cohort study population and those of the martin county population. of those who registered, there were 152 participants consented and enrolled in the baseline cohort. participants (n = 152) had a mean age of 56 years, with the majority (n = 99, 65.1%) identifying as female. most participants reported an annual household income less than usd $20,000 (n = 90, 59.2%) and 39.5% report receiving snap benefits within the last month. table 2 outlines household shopping practices. respondents shop at grocery stores (80%) or supercenters (20%) and primarily shop there due to price (42%) and location (41%). these practices were not significant when stratified by snap participation. participation in snap was associated with an awareness of the farmers' market (p = 0.04), yet not with regularly shopping at this venue (p = 0.31). findings from the regression analyses are in table 3 . among all participants, the overall mean fv intake was 3.46 daily servings (95% ci: 3.06-3.91). males not participating in snap (4.45 servings; 95% ci: 3.43-5.76) and females participating in snap (3.94 servings; 95% ci: 3.12-4.99) reported highest fv intakes within the sample. there is no significant effect for daily fv intake by residency or education. among all participants, 29.1% reported food insecurity, with a greater percentage of snap participants reporting being food insecure (41.7%) than non-participants (20.9%). logistic regression models indicate that snap participation was associated with food insecurity (p = 0.007) compared to those not participating in snap. those participating in snap were two times more likely to report being food insecure relative to non-participants (or = 2.707, 95% ci: 1.317, 5.563). when examining food insecurity and dietary intake by snap participation stratified by gender (table 4 ), the effect of snap participation on food insecurity was stronger for females (or = 3.136, 95% ci: 1.288-7.636), but not significant for males. it is clear among the literature that numerous factors contribute to high obesity prevalence, including poor nutrition, absence or lack of physical activity practices, and the environment [1, 8, 9] . residents of rural communities experience greater obesity prevalence and limited access to healthy choices related to the environments in which they live [9] . these factors shape rural residents' behaviors, and are well understood as influencing obesity prevalence. additionally, attention to the food environment is imperative in order to increase consumption of healthier foods within rural communities. access to healthy foods, such as fv, must be a grounding consideration of obesity prevention efforts within disadvantaged communities such as those found in rural appalachia. rural communities typically face greater financial burden compared with urban communities, particularly in the south, [18] and low household income augments obesity prevalence [37, 38] . we did not specifically investigate income within this sample because of collinearity between income and snap participation. therefore, we used snap participation as our independent variable to measure ses, given that nearly two-thirds of the current population report an annual income less than usd $20,000 and nearly half receives snap assistance. our findings illuminate a growing trend between rural residency, snap participation and food insecurity. it is interesting to note that snap participants were more likely to report being food insecure, suggesting immediate intervention is necessary within this population living in an impoverished community. previous studies have found snap participation to improve food security [22] ; however, our data suggest that those in snap are currently experiencing high rates of food insecurity. this paradox reveals high rates of reported food insecurity despite snap participation, leading to questions of adequate parameters or potential pitfalls. perhaps snap alone is not sufficient to reduce food insecurity, yet is a necessary factor to help prevent higher rates among those who are eligible for snap participation. some suggest that snap participants have lower fv intakes due to unobserved preferences [39] while others have found snap participants would be more food insecure if benefits were not available [40] . thus, improving diet quality while simultaneously combating food insecurity requires nuance. although snap participation provides an avenue to food security, it is clear that when compounded by additional factors, such as the economic disparities this rural appalachian community experiences, it does not equate to consistent nutritional nourishment for these areas. furthermore, rurality and geographic location are important factors to consider when it comes to food security and snap participation. previous studies have even shown that rural geography contributes to differences in food perceptions and purchasing patterns, due to differences in access and availability [41] [42] [43] . this could explain, at least in part, the barriers in the appalachian region. the appalachian region includes all or parts of 13 states where 42% of the population is rural, compared with only 20% throughout the u.s. [44] . appalachian communities experience a high propensity for food insecurity and poverty. across the appalachian region, the median household income is approximately usd $48,000, compared to usd $58,000 across the u.s. [45] . further, the central appalachian region, which includes all of the appalachian counties in kentucky, maintains an annual household income of usd $36,000 [45] , which may mean these communities are more disadvantaged than other rural and appalachian communities across the u.s. our findings further identify martin county as representative of a geographically isolated and persistently impoverished area in central appalachia with exacerbated food insecurity. snap participation could be a mitigating factor to improve diet quality and food security among food insecure individuals [17, 40, 46] . thus, food access initiatives must also consider affordability and snap participation with obesity prevention efforts focused on improving diet quality. our study also reveals that gender may influence food insecurity and would be valuable to examine in future investigations. gender was the only covariate that had a significant effect within our sample, suggesting it may be more salient in terms of food insecurity among rural residents. the effect being stronger for females could have occurred for various reasons, including differences in other constraints for food insecurity between men and women, though we did not explore this relationship in the present study. examining the relationship between gender and food insecurity will aid in understanding why individuals in rural communities are able or unable to access healthy foods. although increasing access to nutritious foods, including fv, may be challenging in a community with limited income, it is possible [47] [48] [49] . rural communities continue to struggle with food accessibility within the retail food landscape, and in a particularly impoverished community, such as the one of this study, addressing the mechanisms and avenues that support food access is imperative. recently, covid-19 incidence has shed light on the disparities that exist between low-income and higher income households [50] . rates of food insecurity have risen dramatically in the u.s., given a host of factors related to covid-19 virus [51] . thus, current programmatic and intervention efforts are critical to assist communities in dire need. further, as figure 1 depicts, much of the existing food system is heavily reliant on food assistance programs such as food pantries, usda subsidized commodity foods, and small-scale church assistance [52] . therefore, a mode of improving health status and dietary consumption would be to target these outlets and enhance offerings to individuals that utilize this network of need-based food assistance. while environmental modifications are pivotal for sustained change, so too are policy considerations. the implications of these baseline findings align with the opportunities laid out for federal nutrition research within the u.s. [53] . this work allows us to grasp the influence of the food environment and other environmental determinants on health disparities, as well as potential relevant solutions. it is evident that policies that dictate federal nutrition program funding and allocation must consider social determinants of health within vulnerable populations. these findings also illuminate the broader systemic issues that underpin the growing rates of food insecurity within these regions exacerbated by the covid-19 pandemic. currently, snap is the only federal nutrition support offered during covid-19, in the form of emergency allotments, adjusted verification requirements, and expanded benefits to children [54, 55] . while these policy changes are temporary, they highlight larger issues and provide a platform to build upon for future research and policy development. our findings demonstrate that providing snap benefits alone is not sufficient to eliminate food insecurity in rural populations. thus, we need stronger policies that improve how we reach all vulnerable populations with improved food access. collectively, these findings elucidate the need for intervention, as the burden of obesity and food insecurity are major public health concerns that frequently coexist within rural communities. however, tailoring interventions to rural appalachian communities, and other communities with unique needs such as these, is vital to implement sustainable solutions successfully. thus, these factors should be considered together in order to construct an understanding of the intricate interrelationship between them. in rural appalachian communities with fewer resources, using existing assets and infrastructure are critical for community-based efforts related to food system enhancements [56] . while we are not directly influencing individual behavior with future interventions, traditional ces programing encompasses direct education focused on food procurement, preparation, preservation, and nutrition. researchers cannot neglect these concepts when implementing community-level systems or environmental changes. obesity prevention efforts must be multifaceted to address all levels of the socio-ecological model. these data create a critical baseline for a prospective cohort study that will allow us to measure the ongoing work of the cdc hop project in martin county. since the time of survey administration, several strategies have been implemented, or will be considered for implementation, to encourage healthy eating and active living as a well-rounded approach for obesity reduction and prevention. these strategies include nutrition and environmental audits of gas stations and grocery stores [57, 58] , a community garden [59] , an in-store marketing initiative [60, 61] , a community-wide walking challenge [62, 63] , and enhancements to existing walking trails in partnership with the public library [64] . these approaches have led to the formation of additional partnerships within the community emphasizing healthy lifestyle behaviors. collectively, these projects and partnerships further augment healthy eating and active living initiatives aimed at reducing obesity in this highly obese community. the generalization of the study findings is limited due to the study's sample of participants from one rural appalachian county in kentucky, which may not be representative of all rural communities in kentucky, or in other states. while verbally administered by a trained interviewer, self-reported survey responses may include social desirability or recall bias and other errors. we aimed to minimize bias by including validated survey instruments. furthermore, researchers verbally administered the survey to reduce concerns of participants with low literacy and to reduce the likelihood of missing data due to skipping questions or not following question instructions. this format also aided in reducing survey fatigue, as the survey was 13 pages long. a portion of surveys were self-administered; however, sensitivity analyses conducted between self-administered and verbally administered surveys revealed no significant differences in findings. results of the analyses are available upon request. because our survey was cross-sectional, we are unable to determine causality with these results. moreover, these are baseline data used to understand the priority population. thus, we are not powered on interactions and results should be interpreted with caution. however, these data represent the baseline findings of a longitudinal study, which will eventually allow us to estimate causal relationships. the findings of this study support continued collaboration with community networks to identify and implement strategies to address accessibility of nutritious foods. while obesity prevention efforts continue in rural areas, this community's high obesity prevalence, coupled with low fv intakes and high food insecurity, suggests community-based efforts aimed at improving healthy food access would prove beneficial. furthermore, tailored health-promoting initiatives that consider rurality and snap participation may have the greatest impact. therefore, important next steps include leveraging existing relationships with local food providers to encourage healthier choices via food pricing and marketing strategies at their venues. additional collaboration with local partners, such as a community health coalition and the ces, is vital to appropriately design and implement programs that consider these specific identifiers and enhance access to venues offering healthy foods. prevalence of obesity among adults from rural and urban areas of the united states: findings from nhanes the relationship between rural status, individual characteristics, and self-rated health in the behavioral risk factor surveillance system rural/urban differences in self-rated health: examining the roles of county size and metropolitan adjacency spatial patterns of rural 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walkable neighborhoods this article is an open access article distributed under the terms and conditions of the creative commons attribution (cc by) license we gratefully acknowledge the contributions to this study by jennifer hunter and would like to acknowledge the martin county cooperative extension office and the martin county health coalition for their ongoing support of this project. we would like to thank grace anderson (uk undergraduate student), haley copeland, caroline blincoe, and cora teets (uk graduate students) for their assistance with data collection and data entry. this research utilized the center for clinical and translational science redcap tool, supported by the nih national center for advancing translational sciences through grant number ul1tr001998. the content is solely the responsibility of the authors and does not necessarily represent the official views of the nih. the authors declare no conflict of interest. the funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results. key: cord-025246-zah72cd6 authors: lai, daniel w. l.; ruan, yongxin title: revisiting social work with older people in chinese contexts from a community development lens: when east meets west date: 2020-03-13 journal: community practice and social development in social work doi: 10.1007/978-981-13-6969-8_13 sha: doc_id: 25246 cord_uid: zah72cd6 community development is an empowering and comprehensive method for social workers to address individual and societal challenges facing chinese older people. this chapter explores the different meanings of community development in chinese contexts, including communities in mainland china and chinese immigrant communities. when actualizing community development, social workers require theories to guide their actions, and this chapter proposes three interrelated theoretical bases: ecological system theory, empowerment theory, and anti-oppressive theory. based on these theoretical bases, three practice directions are suggested to guide community development at different levels: “aging in place,” “age-friendly community,” and “gray power.” in particular, social workers need to adapt community development approaches to chinese cultural contexts. case examples are discussed to illustrate how to implement community development projects with older people in chinese contexts and the roles of social workers in such projects. improvements in healthcare and standards of living have resulted in an increase in longevity and in the size of the aging population. with at least one or two decades of life span after official retirement age, many older people are faced with more choices and opportunities to further enhance their own aspirations and enrich their purpose in life. thus, working with older people should not only focus on remedial interventions that deal with problems and challenges but also on supporting these new aspirations and opportunities. social work with older people involves different approaches within different sociocultural contexts. from a community development perspective, social work with older adults can take many forms. while some may address problems such as health concerns or social inequity issues, others have focused on empowerment and addressing personal development among aging populations. this chapter will discuss the conceptual bases of community development approaches that are used for working with older people in the community. focusing on the experience of older people in different chinese contexts, including chinese older adults in chinese societies and older chinese migrants residing in non-chinese societies, this chapter will discuss the alignment of community development and its application in social work practice with older people, with attention to the influence of sociocultural context. as they age, people experience various challenges, on both individual and societal levels. while chinese older adults in chinese societies and older chinese migrants residing in non-chinese societies face particular challenges associated with their different contexts, they also face some similar challenges. at the individual level, older people, including chinese older people, face physical, social, and psychological challenges associated with increased age. they may experience declining cognition and mobility along with increased likelihood of illness and disabilities (coyle and dugan 2012; lai et al. 2016) . their social network may decrease due to the loss of spouses and friends (coyle and dugan 2012) , and they may be more likely to experience negative emotions, anxiety, and depression due to physical decline, life transitions, and a decrease in social networks (parker 2013) . additionally, when older people reflect on their life, they may experience a sense of despair associated with perceived failures and regrets (parker 2013) . at the societal level, challenges facing older people, including chinese older people, may be associated with environment, infrastructure, and wider social network dynamics. community-dwelling older people may rely heavily on facilities provided by housing estates (chan et al. 2016) , and social environments that are not sufficiently age-friendly can hinder social interaction . for example, limited access to transportation can decrease participation in social activities among older people . additionally, older people may experience ageism, which refers to stereotypes and discriminations against older people (harris et al. 2018) . societies convey ageism in various ways, such as media representations of older people as expensive burdens or as vulnerable (hastings and rogowski 2014) . for example, in mainland china, though the chinese tradition emphasizes respect for older people and attaches importance to their contributions, this value is changing (bai et al. 2016) . there is an increasing emphasis on productivity (bai et al. 2016) , which means that the social status of older people is decreasing as they are no longer "productive" after retirement. additionally, in the context of mainland china, as a result of the "one-child" policy, the younger generation faces difficulty in providing sufficient filial support for older people, as expected in chinese tradition. hence, older people may be viewed as a burden for the family, and when older people internalize this view of being a burden to society and family, they experience a greater risk of depression (bai et al. 2016) . some older people experience greater challenges and vulnerability associated with aspects of status, such as being an ethnic minority. this experience, known as "multiple jeopardy," also affects groups of older chinese adults who are immigrants in societies where chinese are the ethno-cultural minority population (chow 2010) . older chinese immigrants not only face challenges common to older people in general but also experience particular physical, psychological, and social challenges associated with their status as ethnic minorities and immigrants in their new communities. owing to language differences, cultural conflicts, and racial or ethnic discrimination, older chinese immigrants may be at greater risk of physical illness (chow 2010) and feelings of marginalization and other psychological distress, such as depression (chow 2010; park 2016) . moreover, worries about being accepted by the majority society can reduce involvement in social life (park 2016) . healthcare and social services may not be user-friendly, due to a lack of culturally sensitive providers as well as language barriers in organizations (chow 2010) , meaning that older chinese immigrants may be prevented from using needed services. the challenges facing older chinese adults, both for those in china and for immigrants, at both individual and societal levels illustrate the need for interventions and supports that address the broader systems and structures that cause these issues. community development, focusing on empowerment and addressing personal development among aging populations, can be effective in addressing physical, psychological, and social challenges. to understand the meaning of community development, it is first important to examine the meaning of "community," given that different definitions of "community" lead to different interpretations of community development. two main definitions can be identified. the first is a "place-based" perspective, which views "community" as a geographic place with physical boundaries, comprised of residents, resources on which residents subsist, and processes through which residents distribute and exchange those resources to address their needs (matarrita-cascante and brennan 2012). the second is a "non-place-based" perspective, which focuses on the connections that people share, such as using the same language or having other shared interests (human resource development canada [hrdc] 1999; twelvetrees 2017) , shaped by boundaries of moral proximity (green 2016) . people may experience both place-based and non-place-based forms of community. for example, older people may be connected with both peers and other age groups within the same neighborhood, as a result of sharing a particular place, while also being connected to other older people in other geographical locations due to commonalities such as challenges, characteristics (including cultural background or migration status), or interests. these two perspectives inform different conceptualizations of community development. scholars adopting a place-based perspective focus on the management of resources in that geographic community (green 2016) , as communities need to rely on resources to subsist and progress (matarrita-cascante and brennan 2012). for example, matarrita-cascante and brennan (2012, p. 297) define community development as a process that "provides vision, planning, direction, and coordinated action towards desired goals associated with the promotion of efforts aimed at improving the conditions in which local resources operate," involving efforts to "harness local economic, human and physical resources to secure daily requirement and respond to changing needs and conditions." scholars following a non-placebased perspective focus on joint efforts by community members to improve their life circumstance. for example, meade et al. (2016) define community development as a process through which "ordinary people" make an impact on their living conditions through collective action, while human resource development canada (1999) interprets community development as a process through which community members take action and propose solutions together to address common challenges. regardless of the perspective adopted, different community development actors will use different approaches, which can be broadly synthesized into three forms of community development (matarrita-cascante and brennan 2012). the first is an "imposed" form of community development, which involves the improvement of community through physical and economic development and is usually promoted by private industry and government actors. the second is a "directed" form of community development, which refers to structural improvement to a community promoted by nongovernmental organizations (ngos) or government, in which community members are invited to participate. the third is a "self-help" form of community development, which implies community members' own efforts to carry out programs or activities (matarrita-cascante and brennan 2012). community development is an important component of social work practice. community development in social work concentrates on empowering various sections of society, such as creating employment opportunity and promoting gender equality (dhavaleshwar 2016) . scholars have discussed different roles for social workers in community development, focusing on advocacy and empowerment. for example, das et al. (2018, p. 389) suggest that social work "has the potential to be mutually supportive to address gaps, design interventions and lobby more influentially for the use of empowering community-based approaches." similarly, gilbert (2014) suggests that through community development, social workers can promote problem-solving in human relationships as well as social change, empowerment, and liberation in order to enhance well-being. effective community development has been described as having the following characteristics: (1) it is long-term, (2) it is well-planned, (3) it is inclusive and equitable, (4) it is holistic and integrated into the bigger picture, and (5) it is initiated and supported by community members (hrdc 1999) . therefore, social workers should pay attention to these characteristics when planning and promoting community development. yet, while the conceptualization of community development is mostly situated in "western" cultural contexts, it is also important to address how community development could be realized as part of social work practice in chinese contexts, which represent the range of different sociocultural and political values emerging among chinese people residing in different juridical contexts. in the context of this chapter, this includes both chinese older adults in chinese societies and older chinese migrants residing in non-chinese societies. given that social, cultural, and other dynamics in chinese community contexts are different from those in "western" countries, community development will involve different approaches and focuses in chinese contexts. even within chinese contexts, community development may be understood differently when working with chinese older adults residing in a chinese jurisdiction such as mainland china as compared to chinese immigrants in other countries such as canada. even within these groups, identities, challenges, and experiences may differ widely. for example, social, political, and economic contexts affecting aging differ across chinese jurisdictions, such as in the cases hong kong and mainland china. similarly, the experiences of older adults in chinese immigrant communities are shaped by factors such as region, community, and language of origin; social, political, and economic contexts in countries and communities of residence; immigration and settlement policies; ethno-cultural community presence; and so on. the following paragraphs further explore meanings of community development among these diverse groups. when working with chinese immigrants, practitioners may adopt a non-place-based perspective on community, focusing on immigrants with chinese nationalities (yeung and ng 2011; yuen 2013) , who may live in different geographic locations. practitioners may have to adapt community development strategies to chinese cultures, which value social harmony, social relationship, and collective good (yeung and ng 2011; yuen 2013) . yeung and ng (2011) suggest that concepts such as empowerment, social change, and equality, which are often identified as elements of community development, may not be easily be adopted by chinese immigrant communities, who may not have been frequently exposed to these western values. although it has been argued that actions focusing on collective good and collective responsibility may be more acceptable (yeung and ng 2011) , social workers can play important roles in facilitating mobilization and socialization with immigrants from chinese cultural contexts, in order to achieve the desire for change as well as processes of individual as well as collective empowerment. for example, yuen (2013) describes a community development project in canada in which chinese immigrants volunteer in building a low-income senior and new immigrant residence and community center. participants enjoyed the socialization aspects of this project, which strengthened their social relationships and contributed to solidarity within the community. family-like connections among chinese immigrations in turn provided sources of support that serve to strengthen social relationships (yuen 2013) . therefore, it is believed that empowerment and equity could also be achieved via focusing on collective efforts and collective goods, reflecting a broader conception of "empowerment" (beyond only individual dimensions). when working with chinese residents in china, the contemporary political situation and structures means that "community" is generally interpreted as a geographic place administrated by a residents' committee and street office (bray 2006) . there are three characteristics of this understanding of community: (1) each community has a territorial space, (2) the nature and functions of the community are determined by the government, and (3) the community performs administrative roles (bray 2006) . this specific definition of "community" means that community development has its own meanings in china, shaped by political, economic, and historical dynamics. since the breakdown of the work unit system (a system intended to facilitate social regulation and provide social welfare in the early developmental stage of modern china (he and lv 2007) ), the community has had to take on functions that were originally performed by the work unit system (li 2013) . additionally, with the increasing number of rural migrant workers in urban centers (bray 2006) , a process of "community building" has been proposed, adapted from the concept of community development (li 2013) . therefore, community development in china often refers to community building, in which the community takes care of various issues (e.g., welfare services, environment, education, grassroots democracy) in order to "promote social development, raise living standards, expand grassroots democracy and maintain urban stability" (see bray 2006, p. 536) . in this sense, community building is, in a way, an imposed form of community development because it is the administrative offices that take on responsibilities to improve the environment in communities, focusing not only on the physical and economic environment but also welfare service provision and cultivation of grassroots organizations in community building. some grassroots organizations have also been initiated and governed by community members in china. for example, the owners' committee was set up by residents, through which they deal mainly with issues in their living areas with their own efforts (li 2013) , reflecting to some extent a "self-help" approach to community development. however, the owners' committee is supervised by the residents' committee (state council of the people's republic of china 2016). therefore, community development in china is mainly promoted by administrative offices in each community, focusing on physical and social environment improvement. when approaching community development work with older people, theories provide the frameworks to enable practitioners to understand events and generate strategies for practice (phillips and pittman 2014). the following sections examine three main frameworks that inform understandings of and approaches to community development with older people as part of social work practice: ecological system theory, empowerment theory, and anti-oppressive practice. ecological system theory provides a framework for understanding the interaction between different levels of systems that comprise both the environment and people (menec et al. 2011 ). the first level is the microsystem, which refers to a person's immediate surroundings, such as family. the next is the mesosystem, which involves the connections between two or more microsystems, such as the interaction between peers and family. this is followed by the exosystem, referring to the social settings that have indirect effects on individuals, such as workplaces, and then by the macrosystem, which consists of larger contexts such as social values and cultural beliefs. the broadest level is the chronosystem, which refers to a person's life transitions or historical events in society. systems in all levels interact with each other (paat 2013) . as community development deals with aspects of the environment, ecological system theory provides a way to comprehensively examine the influence of environments (at different scales) on older people and serves as a guideline to improve these environments. for example, ecological system theory has been used to understand how environmental factors influence the participation of older people in community activities (greenfield and mauldin 2017) . empowerment refers to a process of "letting client, group or community have as much control as possible over the change processes they are involved in" (see vongchavalitkul 2015, p. 14) . empowerment theory emphasizes the participation of community members in the change process, to ensure that they have the power to control this process. as a result of structural challenges, older people, especially those experiencing "multiple jeopardy," may be marginalized from gaining resources and opportunities, which can lead to a sense of powerlessness. therefore, empowerment theory can provide a framework for social workers to facilitate the involvement of older people in community change projects, through which these older people can enhance their resources and address their own needs (irving 2015) . anti-oppressive practice is an approach to work with people who are oppressed by structural inequalities such as poverty and racism, and creating changes to correct the oppressive status is important (dominelli 1998) . this is closely related to empowerment theory, as both pay attention to addressing inequalities resulting from power differences in relationships. therefore, anti-oppressive practice is often used alongside empowerment-focused approaches. societal stereotypes regarding older people mean that they often face oppression. for example, people with dementia might be deprived the right to make their own decisions by carers because they are viewed as people with poor cognitive functions (martin and younger 2000) . therefore, it is important for practitioners to support the establishment of anti-oppressive environments for older people. these three interrelated theories highlight principles of community development such as empowerment, social justice, participation, and so on. together, they can serve to guide the design and operation of community development projects for older people. for example, ecological system theory could be used to raise awareness among older people to examine the influences of their environments (e.g., barriers that lead to inequality, comprising a key element of anti-oppressive practice) or used as a guideline to improve aspects of these environments. as part of community development processes, empowerment can serve as a framework to facilitate the participation of older people and enhance their abilities to cope with and address community issues. it should be noted that when applying these three theories, the different meanings of community development in chinese contexts should be considered, based on the specific experiences and challenges of older adults in chinese jurisdictions as well as older chinese immigrants in other places. for example, the concept of empowerment and anti-oppression could be adapted to emphasize the principle of collective good in community development with chinese older people. in these ways, social workers can "normalize" community issues and raise awareness among older people about how they, as a group, are disadvantaged by the environments in which they live and potential strategies for change. the following paragraphs introduce three broad practice directions for operationalizing community development in working with older peopleaging in place, age-friendly communities, and "gray power"with a focus on their implementation within the general chinese cultural context. aging in place (aip) refers to "the ability of older adults to live in their homes or communities as long as possible" (see lehning et al. 2017, p. 235) . aip aims to enable older people to maintain their social relationships and daily lifestyle in an environment with which they are familiar, which also facilitates independence and a sense of control over their lives (iecovich 2014) . several theories support the concept of aip and guide its operationalization. the "theory of insideness" focuses on people's attachment to place along three dimensions: physical (sense of environmental control), social (social relationships), and autobiographical (attachment to place, developed from memories that shape self-identity) (iecovich 2014) . older people develop strong ties to a place along these three dimensions (iecovich 2014) and have a high willingness to age in their communities. empowerment theory focuses on helping older people age in place by promoting participation and autonomy (mcdonough and davitt 2011) . person-in-environment theory supports the realization of aip by focusing on mutual interactions between individual and environment: individuals are influenced by their environment but can influence the environment at the same time (weiss-gal 2008) . practitioners can assist older people to adapt to their environment (aging in place) by realizing their potentials and mobilizing the community to support adaptation. scholars have described a "village" model to realize the concept of aip, referring to grassroots organizations that are formed, governed, and served by residents in the community (such as community-dwelling older people) (mcdonough and davitt 2011; scharlach et al. 2012) . those nonprofit organizations provide services for older people in the community through volunteers, generally focused on nonprofessional services such as housekeeping, transportation, etc. (mcdonough and davitt 2011) . social workers can play several roles in promoting aip (scharlach et al. 2012) . as community organizers, social workers can help to foster a sense of commitment to the community and mobilize and support residents to provide assistance for older people in the community. as assessors, social workers not only help community members to understand their challenges and make plans but also help them to evaluate the strengths and resources they have and to use their abilities to support older people. as brokers, social workers connect community members with resources to assist them (scharlach et al. 2012 ). the village model reveals a key concept of aip: mobilizing community members to help community-dwelling older people adapting to place. the process of building, mobilizing, and utilizing capacity of community members to assist older people in the community aligns with chinese cultural and political situations, illustrating its applicability in chinese contexts. first, it reflects an emphasis on the collective good. second, as the community shoulders the responsibility for development, this requires joint efforts from residents (yan 2011) . in china, for example, administrative offices encourage self-help from residents to reduce the burden of solving problems in communities, including by cultivating grassroots organizations, which relies on mobilizing, building, and utilizing the capacity of community members. one way to do this is by promoting volunteering, as volunteers acquire knowledge and skills as well as utilizing their abilities in this process (akingbola et al. 2013) . social workers can improve the commitment of community members to be volunteers, by mobilizing them, assessing their existing strengths, and enriching their knowledge and skills through training (guo 2018) . scholars and practitioners in china have emphasized the importance of recruiting volunteers to assist communitydwelling older people, such as a project in which the "young-old" assist the "old-old," which involves cultivating "young-old" volunteer teams who are trained to apply their knowledge and skills to assist "old-old" people with daily living (e.g., meal delivery) and mental health (e.g., reducing loneliness through home visits) (hong 2012 ). age-friendly communities (afcs) focus more on the influence of the environment, referring to "policies, services, settings and structures support and enable people to age actively" (world health organization [who] 2007) . this involves a focus on both the physical and social environment in the community (including issues such as safety, accessibility, and stereotypes) across eight interacting domains: transportation, housing, outdoor spaces and buildings, social participation and interactions, respect and social inclusion, civic participation and employment, communication and information, and community support and health services (who 2007) . two theories can be used to interpret and support afc. first, the personenvironment fit perspective assumes that people are likely to be maladapted if there is a low level of fit between their needs and environment (park et al. 2017) , indicating that environment plays a crucial role in individual's adaptation. therefore, "even those who have limited resources and capability can age optimally if environmental characteristics support them in a way that compensates for their limitations or lack of resources" (see park et al. 2017 park et al. , p. 1328 . in this sense, an age-friendly environment is helpful for vulnerable older people to age well because, for example, it compensates for personal limitations such as disability by building lifts to increase mobility. second, ecological system theory reveals interactions between people and various systems in the environment (menec et al. 2011) , which is highlighted in afc efforts. for example, social participation influences social inclusion, but social participation depends on the accessibility of outdoor spaces (who 2007) . the achievement of afcs relies on addressing issues such as commitment, capacity, collaboration, and consumer involvement (scharlach and lehning 2016) , in which social workers can play a role. first, it is important to improve commitment of relevant stakeholders to facilitate change in a community, and social workers can help to reduce ageism and enhance awareness of the importance of building afcs. second, social workers can serve as educators to enhance community capacity for developing and implementing afc change processes. third, since change processes require joint efforts from various stakeholders, social workers can be mediators to facilitate stakeholder collaboration. creating afcs relies on interdisciplinary collaboration between various stakeholders. however, this is not easy to create and sustain, and social workers require skills and knowledge (and thus training) to lead collaboration (garcia et al. 2010) . finally, social workers can facilitate the involvement of older people in developing afcs, which is important because it can support greater responsiveness to community needs, capacity building, and empowerment, as well as enhanced use of existing and new programs and services (scharlach and lehning 2016) . as rémillard-boilard et al. (2017) note, the inclusion and participation of older people in developing an age-friendly community is important to achieve age-friendliness. for example, in an age-friendly project in guangzhou, china (lai et al. 2017) , older people in different communities were invited to take part in sharing views and generating ideas about how to make their community more age-friendly. however, chinese older people may have different perspectives on community participation. for example, older people in china do not have strong sense of citizenship and may have limited understanding of the importance of community participation and thus may have low willingness to participate in community initiatives (zhao and huo 2018) . older chinese immigrants, who value social relationships where trust is developed, may not be willing to participate in activities that do not include people they trust (yeung and ng 2011) . therefore, social workers should explore and address potential barriers to the participation of chinese older people as part of afc initiatives. "gray power" "gray power" (gp) is a term mentioned frequently in policy and refers to the political power that older people have (davidson 2012) . as the number of older people is increasing and the new generation of older people has higher awareness of improving public services through political actions, their influence on policy is increasing (davidson 2012) . in response to structural barriers such as ageism, older people can use their "gray power" to improve their community and society. two theories support the idea of gp and provide insights into its operationalization. anti-oppressive practice considers how people are deprived of power due to structural inequalities (dominelli 1998) , and this perspective can assist older people to aware of the oppressions they are facing and understand how their powers are restricted. empowerment theory includes three levels, micro, mezzo, and macro, and macro-level empowerment focuses on influencing resource distribution through collective action (kruger 2000) , revealing a process through which older people can use their power to fight for more resources. social workers can play important roles in assisting older people to exert their power. first, social workers can be educators to raise awareness of how structure barriers lead to particular challenges and problems (mchugh 2012) and can support and strengthen older people's abilities to access information and take action (inaba 2016) . second, social workers can serve as facilitators to bring older people together and support them to generate solutions and seek policy changes (inaba 2016) . for some older chinese adults in mainland china, some moderate strategies to address community issues may be preferred, due to their sociocultural and political upbringing. for instance, one approach used by community workers and researchers is photovoice and may be considered. this is a qualitative research method that enables people to record (through photographs) and reflect on strengths and concerns in their communities, promotes critical thinking about the influence of environment on individuals through discussion of photographs, and reaches who can make changes such as policy makers through the exhibition of photographs (sitter 2017) . when discussing their photographs, participants reflect on how they relate to their lives; the reasons for which a problem, concern, or strength exists; and what can be done about it (sitter 2017) . individuals are empowered by voicing their concerns and raising awareness of concerns in the community and among policy makers (sitter 2017) , which can lead to policy changes. chui et al. (2019) describe a photovoice project to raise civic awareness among older people in hong kong. older people received training on skills such as theme identification and presentation, and a public photo exhibition was launched to raise public awareness. this enhanced participants' ability and willingness to participate in community and civic affairs. in this way, social workers can support and facilitate the empowerment of older people and maintain an equal position with participants throughout the process (sitter 2017) . these three practice directions are interrelated and show a progressive relationship. aip focuses more on individuals' adaptation to the environment, at the micro level, while afc emphasizes improving physical and social environment in the community for older people, at the mezzo level. lastly, gp focuses on policy and political changes, at the macro level. through engagement with these three practice directions, social workers can support community development processes with older people in a comprehensive way. chinese older people encounter various challenges, from individual to societal levels, illustrating the need for comprehensive responses beyond the individual level. social workers can apply the practice of community development in working with chinese older people, representing an approach to intervention and support that addresses broader systems and structures and focus on empowerment and personal development among aging populations. this chapter has explored definitions of community development and its meanings, with a focus on diverse chinese contexts, including those of chinese older adults in mainland china and chinese immigrants in non-chinese societies. three interrelated practice directions, including aging in place, age-friendly communities, and "gray power," provide insight into how social workers can engage in community development processes with older people, including in chinese contexts. the following describes two cases of community development projects with older chinese immigrants, which integrate the concepts of empowerment theory and antioppressive practice. the two cases reveal how social workers can apply these two concepts in community development with chinese older people and the roles they can take on in such projects. one particular challenge that older chinese immigrants may experience concerns elder abuse when living with adult children and their families. they may tend to hide abuse due to a fear that their children would desert them and the cultural belief of not disclosing family matters to outsiders. as a result, there may be little awareness of this issue among community members. in a community development project in canada (lai and luk 2012) , raising awareness of elder abuse among chinese older people and their children was the goal. some chinese older people were invited to talk about incidences of elder abuse and then were involved in group discussions to generate solutions for educating community members about this issue. they decided to design a comic book to present the problem of elder abuse, as they thought that pictures would be easier to comprehend than words and would be readable for older people with low literacy capacities. social workers invited some experts to design the comic book with the older participants, and the comic books were distributed to various elderly centers. this case integrates the concept of empowerment. social workers empowered chinese older people by raising their awareness of an important community issue and supporting those older people to take action to tackle this issue. throughout the project, chinese older people were responsible for discussing the issue, generating solutions, and implementing those solutions. social workers acted as facilitators and brokers (linking participants to resources). the most challenging part was raising awareness of elder abuse among older chinese immigrantsan important step in the empowerment processbecause it contrasted with chinese cultural concerns. therefore, social workers needed to normalize the issue and ensure that chinese older people were aware that this issue influenced their wellbeing. the second case involves a project to involve chinese older people in calgary, canada, into combatting discrimination. in 2003, there was a sars (severe acute respiratory syndrome) outbreak in calgary, and some members of the public thought that chinese people had brought the virus to their city. older chinese immigrants not only experienced public discrimination, but also worried about their vulnerability to sars. in this case, workers at a chinese senior center brought the chinese older people together to discuss the issue and later launched a public meeting with representatives of government health officials and local politicians to discuss how to reduce public stereotypes toward sars and the chinese community. in this case, social workers applied the concept of empowerment and antioppressive practice. chinese older people were supported to take collective action and expressed their perspectives in order to reduce public stereotypes. through this process, their capacity to express and present opinions and discussion skills were improved, and their social networks were strengthened or extended. social workers serve as mediators in discussions between chinese older people, health authority officers, and legislative counselors. social workers also took on roles as facilitators and brokers to support chinese older people to take collective action and provide necessary resources. these two cases illustrate that when social workers carry out community development projects with chinese older people, they can serve as facilitators to raise awareness of community issues and as brokers to link older people with resources such as networks with other professionals, in order to support chinese older people to deliver collective action. however, given the 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participatory action research method the state council of the people's republic of china (2016) the regulation of property in the people's republic of china community development, social action and social planning using empowerment theory in health promotion guided development the home for the elderly in nakhon ratchasima, thailand the person-in-environment approach: professional ideology and practice of social workers in israel global age-friendly cities: a guide how to take part in community management in beijing engaging service users and carers in health and social care education: challenges and opportunities in the chinese community building juniper: chinese canadian motivations for volunteering and experiences of community development the situation and improvement of the community participation of the elderly in the middle and small cities key: cord-327494-7a3szj8x authors: ibrahim, mohamed izham mohamed title: chapter 18 assessment of medication dispensing and extended community pharmacy services date: 2018-12-31 journal: social and administrative aspects of pharmacy in lowand middle-income countries doi: 10.1016/b978-0-12-811228-1.00018-2 sha: doc_id: 327494 cord_uid: 7a3szj8x abstract individuals who visit community pharmacies are regarded as customers rather than patients. the public tends to view community pharmacists as businesspeople. several factors influence individuals' willingness to patronize and to continue visiting such pharmacies. on the supply side, community pharmacists' responsibilities and duties center on the health and well-being of society. in this chapter, an assessment of community pharmacy practices in developing countries is particularly interesting in terms of medication dispensing and extended pharmacy services that promote public wellness. community pharmacists in developing countries, who are supposedly strategically positioned in the community to provide public health, are not taking advantage on this opportunity. although several studies have noted the services provided by community pharmacists, in general, the practice is far from meeting expectations due to several barriers. pharmacists need to realize their opportunities and potential for success as both professionals and businesspeople. pharmacists serve individual, community, and societal needs. brodie (1981) proposed that pharmacists' basic role has to expand based on advancements in technology and knowledge. in the past, pharmacists' main purpose was to prepare medicines and to ensure their availability. however, pharmacists can now react to external forces (e.g., economic, epidemiological, demographic, and technological) that are reshaping the profession by positioning themselves within the medication use system and being in control of the process. helper (1988) suggested that pharmacists be more knowledgeable and focus on their fundamental pharmacist-society relationship to improve public health. in 1946, who defined health in its constitution: health is a state of complete physical, mental and social well-being, not merely the absence of disease or infirmity. this is the most quoted definition of health, which clearly stresses "well-being." four decades later, who (1984) revised its definition as follows: health is the extent to which an individual or group is able, on the one hand, to realize aspirations and satisfy needs; and, on the other hand, to change or cope with the environment. health is, therefore, seen as a resource for everyday life, not an object of living; it is a positive concept emphasizing social and personal resources, as well as physical capacities. in developing countries, healthcare needs are more pressing than those in developed nations. unfortunately, for various reasons, the provision of care is inadequate, particularly in the public sector; it is even worse in the private sector. who (2005) has highlighted the importance of improving, monitoring, and evaluating people's wellness and quality of life, which, as a public health concern, should be the goals in a country's national development. in 1920, winslow defined public health as follows: [public health is] the science and art of preventing disease, prolonging life and promoting health through the organized efforts and informed choices of society, organizations, public and private, communities and individuals. (winslow, 1920) public health is an organized effort to maintain the health of the people and to prevent illness, injury, and premature death by focusing on prevention and health protection services (the association of faculties of medicines of canada, n.d.) . another relevant community-related concept is primary healthcare. primary healthcare was the core concept of who's goal in health for all, which was based on the alma ata declaration in 1978 (who, 1978) . due to high healthcare expenditures, moving some of the healthcare focus from the tertiary level to the primary level is perhaps justifiable. primary care also aims to decrease the public's reliance on hospitals to fill drug prescriptions. according to who, to achieve health for all, people must be put at the center of healthcare (who, 2007) . people-centered care is focused and organized around the health needs and expectations of people and communities rather than on disease itself (who, 2015) . if people and society are the core of the "health for all" mission, then where do community pharmacists belong as healthcare providers? do the pharmacy and community pharmacists fit within the system? in this chapter, an assessment of community pharmacy practices in developing countries is particularly interesting in terms of medication dispensing and extended pharmacy services. the chapter also seeks to examine the significant societal contributions of community pharmacists, including the challenges and gaps in practice. this chapter will also focus and discuss the expected role, function, and responsibilities of community pharmacists in developing countries. this is based on the aforementioned concepts of "health," "public health," and "primary healthcare." a community pharmacy is a healthcare facility that provides pharmaceutical and cognitive services to a specific community. from independently owned pharmacies to corporately owned chain pharmacies, a variety of pharmacies are in operation. in some developing countries in africa and asia, the terms "drug outlets," "retail drug outlets," "retail drug shops," and "private pharmacies" are commonly used. community pharmacists must strategically position themselves in the community to serve the public health. community pharmacies can be found on main streets, in malls and supermarkets, at the heart of the most rural villages, and in the center of the most deprived communities. in some countries, many community pharmacies are opened early and closed late when other healthcare professionals are unavailable (cpni, no date). according to who (1994) , among healthcare providers, community pharmacists are the most accessible to the public. in practice, a pharmacy provides medications and other healthcare products and services and helps people and society make the best use of them (wiedenmayer et al., 2006) . community pharmacists supply, dispense, and sell medications according to the law. a proper dispensing practice will interpret and evaluate a prescription; select and manipulate or compound a pharmaceutical product; and label and supply the product in an appropriate container according to legal and regulatory requirements (who, 1994) . in addition, pharmacy activities include a pharmacist's provision of information and instructions to patients, and, under a pharmacist's supervision, practices will ensure the patient's safe and effective use of the medicines. in some countries, pharmaceutical services go beyond these basic services. these services or functions (e.g., counseling, drug information, blood pressure monitoring, immunizations, and diabetic selfmanagement) will require professional knowledge and skills beyond those required to dispense prescription medications (wiedenmayer et al., 2006) . these services include all those delivered by pharmacy personnel to support the delivery of pharmaceutical care. beyond the supply of pharmaceutical products, pharmaceutical services include information, education, and communication to promote public health; the provision of drug information and counseling; regulatory services; and staff education and training (wiedenmayer et al., 2006) . hepler and strand (1990) coined the term "pharmaceutical care," which they defined as "the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve (or maintain) a patient's quality of life." this collaborative process aims to prevent or identify and solve pharmaceutical and health-related problems-a continuous quality improvement process regarding the use of medicines (wiedenmayer et al., 2006) . the philosophy of pharmaceutical care promoted in the early 1990s is no longer new. many studies, initiatives, and interventions, especially in developed countries, have been conducted to improve patient care and health outcomes. in an attempt to provide health and pharmaceutical care to patients and society, the healthcare and pharmaceutical sectors in developing countries, particularly low-and middle-income countries (lmics), are facing challenges. these challenges include the shortage of human resources in the pharmacy workforce; inefficient health systems; the rising costs of medicines and healthcare; limited financial resources; the huge burden of disease; and changing social, epidemiological, technological, economic, and political situations (mohamed ibrahim, palaian, al-sulaiti, & el-shami, 2016) . in general, pharmacists play an important role in the healthcare system through the provision of medicines and information (accp, no date). pharmacists are drug experts who focus on patients' health and wellness. the competency standards for pharmacists in australia (shpa, 2003) mentioned several important functional areas that community pharmacists could assume: dispensing medication; preparing pharmaceutical products; promoting and contributing to the quality use of medication; providing primary healthcare; and supplying information and instructions related to health and medication. what kind of value and benefits does the public really gain from community pharmacy practice? despite the widely acknowledged potential of community pharmacies in developing countries to respond to public healthcare needs, related developments have been limited (smith, 2004) . in addition, the quality of community pharmacy practices has also been questioned. in many countries, especially in lmics, community pharmacists have only performed the basic or traditional role (i.e., as a drug dispenser), and they have sometimes indulged in unethical practices. studies have reported mixed findings: community pharmacies make a contribution to society, but they are also problematic (i.e., they do not meet expectations and provide low-quality services). in estonia, since the restoration of independence in 1991, community pharmacies have become more patient-oriented, even though the government has not pressured pharmacies to offer extended services. in addition to dispensing, pharmacies still compound extemporaneous products and sell herbal medicines. community pharmacists continue to perform their traditional roles (volmer, vendla, vetka, bell, & hamilton, 2008) . prior to 2007, clinical pharmacy was never practiced in community pharmacy settings in peru. however, the pharmaceutical care initiative has been reported to be growing and well supported by the law. peruvian pharmacists are encouraged to take this opportunity to expand their services (alvarez-risco & van mil, 2007) . in china, pharmaceutical care services are underdeveloped but, with the improvement of the chinese pharmacist law, they will become an important part of the pharmacist's professional role (fang, yang, zhou, jiang, & liu, 2013) . pharmacists in vietnam are encouraged to expand their role-from drug sellers to client counselors, drug treatment managers, adherence counselors, and advisors on illness prevention. pharmacies are often the first place that people visit to seek medical help, and they serve as a source of health information and services. the intervention that has empowered pharmacists to serve as client advocates and client counselors has identified a few improvements, such as knowledge, behavior, increased client satisfaction, and pharmacist-healthcare provider relationships. pharmacists can move beyond the traditional role of selling drugs to be more effective healthcare professionals, and they need continuing professional development (cpd) (minh, huong, byrkit, & murray, 2013) . from another perspective, evidence has shown that community pharmacists perform far below public expectations. patients have encountered several problems and challenges related to community pharmacy practice, which can be discussed according to pharmacy, pharmacist, prescription, service, and system factors. studies have reported that community pharmacists in developing countries, especially lmics, do not provide quality services. a quick look at 19 developing countries shows that the community pharmacy practice setting is regarded as popular. unfortunately, this practice setting also presents some concerns. for example, some countries allow nonpharmacists to operate pharmacies and to handle medicines. in some countries, the practice of community pharmacy is not well regulated, with little to no minimum standard of practice (hussain, mohamed ibrahim, & zaheer, 2012d) . many pharmacy personnel who dispense medicines are unqualified, with no college/university diploma or professional degree in pharmacy (lenjisa, mosisa, woldu, & negassa, 2015) . a study in turkish republic of northern cyprus (gokcekus, toklu, demirdamar, & gumusel, 2012) reported that the pharmacy employees have no pharmacybased training and that pharmacists believed that their employees are capable to handle the prescriptions. studies in qatar, pakistan, malaysian, and sudan have indicated that dispensing and labeling practices and provider-patient interactions are poor (alamin hassan, mohamed ibrahim, & hassali, 2014; hussain & mohamed ibrahim, 2011; hussain et al., 2012d; mohamed ibrahim et al., 2014; osman, ahmed hassan, & mohamed ibrahim, 2012) . in addition, a few dispensing errors have been identified (lenjisa et al., 2015) . according to basak, arunkumar, and masilamani (2009) , community pharmacy services in india are quite problematic, and the pharmacy's role in healthcare remains unrecognized. these authors have called for reform to meet societal needs. a study in nigeria found that some community pharmacists often administer injections for customers-in some cases, without a prescription. the number of prescriptions that community pharmacists receive is low. they suffer from the limited availability of some resources, which has a serious impact on their practice (adje & oli, 2013) . a review of community pharmacy practices showed that, in some countries, pharmacy outlets were run by nonpharmacists; dispensing practices were unsatisfactory; drug sellers' level of knowledge regarding diseases and medicines was poor; medicines were used irrationally; pharmacies were not meeting the government's licensing requirements; medication storage conditions were improper; and customers could hardly meet with pharmacists (hussain, mohamed ibrahim, & babar, 2012a , 2012b , 2012d hussain & mohamed ibrahim, 2012) . a study on over-the-counter (otc) counseling in brazil (halila, junior, otuki, & correr, 2015) concluded that even though the most important factors taken into account when counseling an otc medicine were drug's efficacy and adverse effects, but only few pharmacists knew the meaning of terms related to evidence-based health. poudel, subish, mishra, mohamed ibrahim, and jayasekera (2010) reported that unregistered fixed-dose combinations of pharmaceutical products (e.g., antimicrobial combinations, nonsteroidal antiinflammatory drug combinations, and antimotility combinations) have been found in nepali healthcare facilities, including drug outlets. regarding prescription behavior, even in rural areas of india, the proportion of brand name prescriptions was high (aravamuthan, arputhavanan, subramaniam, & chander, 2017) . other common prescription problems include the lack of information, illegible handwriting, and various errors (e.g., prescription errors, dispensing errors, and improper labeling related to particular standards or requirements) (hussain & mohamed ibrahim, 2011; syhakhang, stenson, wahlström, & tomson, 2001) . pharmacy hours vary: typically, some pharmacies are open for approximately 10 h (e.g., in malaysia), while others offer 24-h services (e.g., in qatar). in some countries (e.g., nepal and sudan), pharmacy hours and operations can be affected by the availability of reliable electrical power supply. some countries do not have conveniently located pharmacy outlets, and customers might have to walk for hours to reach one. some pharmacies lack proper facilities (e.g., a private room for patient counseling), space, reference resources (e.g., drug information), and/or quality medication (e.g., substandard and counterfeit and irrational fixed-dose combinations); have a poor layout, impractically arranged products, and/or disorganization issues; and/or keep and sell expired or almost expired items. developing countries also suffer from an insufficient number of pharmacists. in addition, for economic reasons, pharmacists prefer to work or set up their pharmacies in urban areas rather than in rural areas (smith, 2001 (smith, , 2004 . in addition, some pharmacists are hard to find in pharmacies ("the invisible pharmacist"), and patients/customers have to rely on pharmacy assistants/technicians (amin & chewning, 2016) . most of the time, these staff have no proper professional qualifications and lack important skills and knowledge. even worse, some community pharmacists lack particular competencies and communication skills, have no or few business skills, and do not have up-to-date knowledge. in some cases, pharmacists do not comply with regulations (e.g., selling antibiotics or psychotropic drugs without a prescription), and they often fail to assume responsibility for pharmaceutical care. in the eyes of the consumers, community pharmacists are always regarded as businesspeople rather than as healthcare professionals. community pharmacists must strike a balance between professional and business responsibilities. having both qualities, i.e., having a high level of professionalism and an excellent business sense, should not be so difficult. how these two aspects influence the health and well-being of individuals and society is what matters. the services provided by community pharmacists have been reported to focus more on their distributive function (e.g., basic medication dispensing and sales), not the expected proper medication dispensing practice mentioned above (wiedenmayer et al., 2006) . most of the time, pharmacists provide no advice/counseling; rarely interact with patients and physicians; make no referrals; lack or have few medicines due to poor planning and estimation/quantification; have no records of patients/clients or the medicines dispensed; use little to no technology; mix and prepare medications in the pharmacy rather than according to standards, for example, us or british pharmacopeia (compounding or extemporaneous dispensing); and do not provide drug information that could help reduce medication misadventures. in 2003, the malaysian pharmaceutical society introduced its benchmarking guidelines for community pharmacies. the society sought to raise the standards of practice. unfortunately, a study reported that the level of awareness of these guidelines was low and that only around 60% of the pharmacies complied with them (siang, kee, gee, richard, & see hui, 2008) . the quality of the pharmacy education system has been affected. some countries lack colleges with pharmacy degrees. even if adequate, these colleges often lack quality curricula; the syllabi are out of date and do not cater to the present needs of the healthcare system. in addition, colleges lack staff; even if they have enough staff, they lack quality staff/faculty with appropriate qualifications or expertise. the pharmacy workforce is not carefully planned according to the country's needs. some countries do not have pharmacy associations, which could provide professional leadership, and some even are unable to provide continuing education for pharmacy staff. another critical problem is that there are very few policy makers and regulators who understand the system, who are committed and motivated, and who have sufficient technical know-how to solve the problems. in addition, many countries have a corrupt system and authorities; a weak and unstable government and economy; problems with bureaucracy, middlemen, profits, etc. that affect the final retail price, potentially making it too high for consumers; no or few effective price containment strategies/polices, which have resulted in unaffordable prices (khatib et al., 2016) , especially for the poor and others in need. due to the lack of an attractive salary and benefits, pharmacists have migrated to other countries for better life and career opportunities. as such, nonpharmacists are allowed to own and operate pharmacies in developing countries. the image of the pharmacist and the profession very much depends on customer satisfaction. a study conducted in nigeria showed that customers experienced moderate service satisfaction. customers were mostly dissatisfied with healthcare services that related to pharmaceutical care activities (oparah & kikanme, 2006) . in a patient satisfaction survey conducted in the united arab emirates (uae), scores were significantly lower than published data, suggesting that patients' expectations of community pharmacy services have not been met there (hasan et al., 2013) . dhote, mahajan, and mishra (2013) mentioned that the rise of pharmaceutical care services must be accelerated based on the rapid changes in consumers' expectations. best practices can be adopted and adapted according to a country's needs and conditions. does "one size" really fit all? is "comparing apples and oranges" difficult? adopting 100% of one country's practices in another country is unwise. many factors need to be considered. no country has a perfect system; however, community pharmacists in developing countries can definitely learn from at least one practice or service. according to brodie (1981) , the traditional role of dispensing medications has been expanded. pharmacists should be both health generalists and health specialists, which will have an impact on public health. even the american public health association (1981) supports the pharmacists' role in public health. should community pharmacists move beyond their traditional role? even when dispensing medicines through paper-based prescription services, pharmacists should comply with some fundamental standards. safety issues must be considered when dispensing medications. the pharmacy board of australia published guidelines for medication dispensing (i.e., guidelines for scanned and faxed prescriptions and steps to take when handling internet or mail-order dispensing); guidelines for dispensing extemporaneous medications; guidelines when handling errors (e.g., dispensing errors); guidelines for appropriate medication labeling; guidelines for patient counseling, privacy, and confidentiality; and pharmacy technicians' functions, responsibilities, and competencies (pharmacy board of australia, n.d.). in addition, for pharmacies that use electronic and computer systems, the royal pharmaceutical society of great britain (n.d.) has provided several guidelines and principles for good dispensing and appropriate dispensing procedures (e.g., professional checking, medication substitution, and labeling). malaysia, a developing country, has also developed guide to good dispensing practice (malaysian pharmaceutical services division, 2016) . these guidelines aim to have both public and private facilities dispensing medications according to the law and guidelines, which may ensure that patients receive the correct medications, adherence is improved, adverse effects are minimized, and errors are avoided. the document's contents relate to processing prescriptions, preparing medications, labeling, recoding, and issuing medications to the patient. in geographical areas where no pharmacists are available, a guide about managing medicines would be a handy document indeed (andersson & snell, 2010) . in some countries, community pharmacists are ready to provide extended services (or cognitive pharmaceutical services). according to cipolle, strand, and morley (1998) , cognitive pharmaceutical services entail the pharmacist's use of specialized knowledge to help patients or health professionals and promote effective and safe drug therapy. these services are simply "clinically oriented activities intended to improve medication prescribing and use" (farris, kumbera, halterman, & fang, 2002) . why are pharmacy practices still outdated in some countries? what are the barriers to quality community pharmacy services? are pharmacists reluctant to move forward? the lack of time, reimbursement, recognition, cooperation with general practitioners, documentation, networking; the location of services within the pharmacy premises; the attitudes of customers and pharmacists; the pharmacy owner's involvement (or lack thereof); the daily organization of services; and customer recruitment for such services are among the barriers to the successful implementation of extended services (cognitive services) (garrett & martin, 2003; gastelurrutia et al., 2009; hopp, sørensen, herborg, & roberts, 2005; rossing, hansen, & krass, 2002) . in some countries, pharmacists have moved away from product-oriented services toward service-oriented and then patient-oriented services, increasingly emphasizing the patient's health outcomes (the economic, clinical, and humanistic outcomes model) (drabinski, 2000; kozma, reeder, & schulz, 1993) . outcomes refer to the consequences (results) of interventions that are made to achieve therapeutic goals. outcomes can have economic, social/behavioral, or physiological characteristics. when community pharmacists are serving the public, in addition to health outcomes, at least four important parameters should be monitored: accessibility, availability, affordability, and acceptability. when patients benefit from the medications that they take, their health improves, which ultimately reduces costs (wiedenmayer et al., 2006) . the scope of pharmacy practice now includes patient-centered care-with all the cognitive functions of counseling, providing drug information, and monitoring drug therapy-and the technical aspects of pharmaceutical services, including medication supply management, as well as people-or public-centered care. community pharmacies can offer comprehensive healthcare services, including advanced and enhanced services. such services include the rational use of medicines; medication adherence; self-management clinics for group of patients with chronic diseases (e.g., diabetes mellitus, hypertension, and asthma); medication therapy management; screening and monitoring; education for enhancing medication adherence; encouraging and educating patients to receive their recommended immunizations and those for infants; home healthcare services; partnership in palliative care teams; drive-through facilities; mail and internet orders of medicines; rural and remote area services; mobile pharmacy; helping patients with special needs; public health and primary healthcare services (e.g., hiv/aids and drug abuse treatment); distributing literature and educating regarding life style change for stress reduction, proper nutrition, and exercising; collaboration with other healthcare professionals during disease outbreaks (e.g., ebola virus disease, severe acute respiratory syndrome, middle-east respiratory syndrome, and zika virus disease); involvement in an unwanted medicines program; health promotion (the process of enabling people to increase their control over-and to improve-their health, e.g., smoking cessation, obesity management, and diabetic self-management); drug therapy problems (defined as "[a]n undesirable event, a patient experience that involves, or is suspected to involve drug therapy, and that actually or potentially, interferes with a desired patient outcome" (cipolle et al., 1998; strand, cipolle, morley, ramsey, & lamsam, 1990) ); and pharmaceutical public health services. pharmaceutical public health has been defined as follows: the application of pharmaceutical knowledge, skills and resources to the science and art of preventing disease, prolonging life, promoting, protecting and improving health for all through the organized efforts of society. pharmacists could also provide public services, such as local guidelines and treatment protocols, medication use review and evaluation, national medicine policies and essential medicine lists, pharmacovigilance, needs assessment, and pharmacoepidemiology (wiedenmayer et al., 2006) . pharmacists should be at the front line to promote safe sex, birth control education, advice on nursing babies, and caring for elderly parents and relatives. in addition, pharmacists could work with local authorities in the direction of a cleaner and safer environment (air, water, and ground) and for safe food handling. pharmacists should only carry in stock and sell products with proven medical value, not selling tobacco products, and not supplements and homeopathic medicines that have no clear scientific evidence of safety and effectiveness. the literature has shown that community pharmacists in some countries have had a positive impact on public health. first, training and education programs have been able to enhance the knowledge and practices of pharmacists. continuing education programs, especially if mandatory, also play a significant role. second, pharmacy colleges have improved by incorporating relevant courses and topics into the syllabi for undergraduate pharmacy programs. third, strong, motivated, and uncorrupted pharmacy authorities/regulatory agencies have been able to improve community pharmacy practices because of their concern, motivation, and effort to make necessary improvements. to progress and gain society's acceptance, community pharmacists must acknowledge the following challenges in healthcare systems: 1� one-third of the world's population is known to lack regular access to essential medicines. for many people, the cost of medication is a major constraint. those hardest hit are patients in developing and transitional economies, where 50% to 90% of medicines are out-of-pocket expenses (who, 1998) . the burden falls most heavily on the poor, who are not adequately protected by current policies or by health insurance. 2� healthcare workers, including community pharmacist, are in short supply, especially in lmics (who, 2016) . 3� some countries are eager to introduce and establish a doctor of pharmacy (pharmd) degree in pharmacy colleges, but due to several reasons, they have failed to produce competent graduates who can apply clinical knowledge in practice or who can distance the practice from its traditional role. 4� the logistical aspects of distribution, often seen as the pharmacist's traditional role (i.e., the "count and pour, lick and stick pharmacy"), represent another challenge. 5� in terms of medication quality, studied medication samples have failed quality control tests (msh, 2012) , and substandard and counterfeit medications are highly likely to be on pharmacy shelves. 6� another major challenge is ensuring that medicines are used as advised or instructed; more than half of all prescriptions are incorrect, and more than half of the people who are prescribed with medications fail to take them correctly. medication adherence can be affected if the medication is unavailable or unaffordable or if the instructions given are not understood or remembered. furthermore, a patient's confidence or trust in the pharmacist or the medications prescribed may also affect adherence. 7� especially in economically deprived communities, self-medication with either modern or traditional medicines is becoming common practice. individuals resort to self-medication when healthcare services become more unaffordable and inaccessible (hughes, mcelnay, & fleming, 2001) . the situation deteriorates when prescription medicines can be easily obtained over the counter. community pharmacists could play a role in mitigating the risks of selfmedication (bennadi, 2013) . given the list of pharmacist-, pharmacy-, and practice-related issues above, are pharmacists still needed in the community and in the healthcare system? if community pharmacists still perform the basic function of medication dispensing or if a country lacks pharmacists, could we simply have medicine vending machines (i.e., a self-service technology) across the country (adams, 2014; poulter, 2010) ? these machines could provide customers access to otc drugs, nondrug items, and information, thereby supporting the self-care concept (steinfirst, cowell, presley, & reifler, 1985) . this technology could be argued to have an adverse effect on customers. for example, the buying and selling process lacks the "human touch," or customers leave the pharmacy without information or take medication incorrectly due to a lack of quality information. however, what is the difference when the same customers visit pharmacies with "invisible pharmacists"? do pharmacists just count pills? if community pharmacists are hesitant or refuse to change, these vending machines will put them out of business. for countries searching for cost-cutting strategies, this technology might be a solution. to be effective healthcare team members, community pharmacists need skills and abilities that will enable them to assume many different functions. who introduced the concept of the "seven/eight-star pharmacist," which the international pharmaceutical federation (fip) adopted in 2000 in its policy statement on good pharmacy education practice to outline the caregiver, decision-maker, communicator, manager, lifelong learner, teacher, and leader roles of the pharmacist. the pharmacist's function as a researcher has since evolved, and all these roles have been addressed in the competence standards (who, 1997, pp. 27-29) . community pharmacists have to make efforts to move from being drug compounders and dispensers to being pharmaceutical care providers and medication experts; their role and function should focus on patient-centered care rather than products and profits. community pharmacists must equip themselves with adequate knowledge and skills and be responsible for ensuring that, irrespective of the medications provided and used, quality products are selected, procured, stored, distributed, dispensed, and administered to enhance patients' health and do them no harm. relevant pharmacy authorities should provide more support, training, and development for community pharmacies to help their pharmacists deliver high-quality services. pharmacy associations could organize programs in collaboration with pharmacy colleges and could involve regional or international experts if affordable. nonprofit international organizations, such as who and management sciences for health (msh), could assist lmics in this matter. in addition, some chain pharmacies could implement monthly programs. community pharmacists must be involved in cpd; individual pharmacists are responsible for the systematic maintenance, development, and broadening of their knowledge, skills, and attitudes to ensure their continued competence as professionals throughout their careers. community pharmacists (with the help of academics from pharmacy colleges, if required) must conduct research to document outcomes and impacts (e.g., accessibility, effectiveness, and positive perceptions of the experience); research must be conducted to assess the minimum standards and quality of community pharmacies and to provide evidence-based practice information. the numbers of published studies from developing countries are very low compared with those from developed countries. managerial and educational interventions are needed to improve the practice. community pharmacists could obtain inputs/ideas and explore the perceptions of community pharmacy staff-in addition to customers and patients-regarding aspects of service quality. these inputs could then perhaps be used to improve the services offered to customers. some pharmacists are able to use information technology to enhance pharmacy and pharmaceutical services; pharmacists in some other countries find doing it so problematic-due to a very basic infrastructure or the lack of basic competencies, among others. finally, who (wiedenmayer et al., 2006) and other sources have provided a guide and systematic approach for delivering pharmacy patient-centered care and good pharmacy and dispensing practice. public health pharmacy interventions, patient-centered care, rational medication use, and effective medication supply management are key components of an accessible, sustainable, affordable, and equitable healthcare system that ensures the efficacy, safety, and quality of medications. the customer's (patient's) expectations are rapidly changing; customers are becoming more aware of their healthcare needs. customers now demand better quality care and more attention to maintain or improve their overall health. evidence has shown that challenges and gaps exist in community pharmacy practice. in developing countries, the functions of community pharmacists must be redefined and reoriented. a paradigm shift in the mind-set and practices of pharmacists is urgently needed. • although the overall level of community pharmacy services provided in developing countries does not meet the public's expectations, gradual progress has been observed. • the number of trained community pharmacists is inadequate; their distribution is unbalanced; and, in some countries, individuals without the professional pharmacy degrees are allowed to work in pharmacies. thus, pharmacy authorities, policy makers, and educators must collaborate to fix these problems and make improvements. • due to the high prevalence of chronic diseases and the need to improve public health and wellbeing, community pharmacists must continue to be competent in their professional and business roles; pharmacists should expand the role in delivering wellness services (e.g., disease-oriented pharmaceutical care) that go beyond filling prescriptions. • many developing nations do not have effective and efficient regulations, guidelines, 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jointly sponsored by the world health organization and the united nations children's fund. geneva: world health organization health reform and drug financing, selected topics, health economics and drugs, dap series no who global strategy on people-centred and integrated health services the role of the pharmacist in the health-care system -preparing the future pharmacist: curricular development people at the centre of health care: harmonizing mind and body, people and systems constitution of the world health organization. geneva: world health organization global strategy on human resources for health: workforce 2030 health promotion: a discussion document on the concept and principles: summary report of the working group on concept and principles of health promotion developing pharmacy practice: a focus on patient care. who (and fip) the untilled field of public health. modern medicine, 2, 183. who. the world health organization quality of life assessment (whoqol): position paper from the world health organization further reading chapter 20: comparative analysis and conclusion key: cord-269387-pgg61svt authors: vandensande, tinne title: starting the transition towards integrated community care 4all date: 2020-06-30 journal: international journal of integrated care doi: 10.5334/ijic.5553 sha: doc_id: 269387 cord_uid: pgg61svt nan integrated community care (icc) is a new concept that has been launched by the international partnership of philanthropic organisations known as transform which came into being in 2018. the transform partners are convinced of the value of investing time, resources and imagination to enhance the capacity of local communities to deal with public health issues and the care needs of community members throughout their whole lifetime. the transform initiative is conceived as a learning journey, since this is the only way to move forward while maintaining a longitudinal perspective and creating space for the necessary learning curve. our hope is that sharing our reasoning and insights will allow interested parties to understand how we can support icc and embed and express it in practice, find the storylines that form the 'icc 4all' narrative and identify principles that could help in building sustainable and context-sensitive icc. icc has an undeniable relevance to all stakeholders and a high face validity. it brings together three generic concepts: "integrated", "community" and "care". in its most rudimentary form, icc is recognized as a much-needed and valuable expansion of more widespread notions of integrated care, explicitly recognising the value, potential and power of communities, citizens and laypeople. going even deeper than this, however, icc deserves its own approach. strengthening communities will require a fundamental shift in the way we value and understand the role of people and communities as an integral part of the system. it involves a shift from an ego-system awareness with the emphasis on one's own well-being, to an eco-system awareness that simultaneously emphasises the well-being of all [5] . integrated community care is now more firmly on the agenda than ever. citizens, neighbourhood networks, community-based organizations and informal carers are all being recognized as key players in tackling the covid-19 crisis as they address the huge needs for psychosocial, practical and food support [1] . bottom-up initiatives are popping up to respond to the needs of the most vulnerable individuals in our communities. the response to the crisis from the voluntary sector has been spectacular. their example inspires us to act differently, cooperate better and innovate faster. cooperation and innovation are necessary if we are to increase the resilience of our health and care systems [2] . icc acknowledges that communities are essential partners that contribute invaluable assets: relationships, expertise, contextual knowledge, entrepreneurship, public space and services, and locally supportive ecosystems. icc seeks to create conditions that will allow people to care for themselves and also for others in their community. it is a whole-of-society approach to health and well-being, centred on the needs and preferences of citizens, families and communities. one key feature of icc is that it moves away from 'delivery' and towards genuine 'co-development'. individuals and communities are no longer framed as recipients. this gives it a greater relevance as it aligns with fundamental shifts taking place in society and in health and care systems. icc is linked to a positive, empowering understanding of health. it encompasses the desire to be a positive force for change amid the multi-faceted transition to a new, sustainable equilibrium for our societies. the main elements of the narrative can be summarised as follows: � icc engages and empowers people in local communities; � icc promotes a sense of accountability towards a territorially defined population; � icc fosters inclusiveness and reaching out to underserved and marginalised groups; � icc activates and reinforces the social ties between people; � icc is goal-oriented in nature, supporting people's priorities and life goals; � icc strengthens communities by tackling social, economic and environmental determinants of health; � icc comes down to a continuous process of wholesystem innovation; � icc requires a social movement to make it a reality. there is no single model for operationalizing icc but a wide range of existing practices express the dna inherent within the concept in different ways. these include, among others, community health centres, vibrant communities and healthy place-making [6] . transform, the international coalition for learning in the area of icc, has identified three storylines to guide us as we seek ways to make icc the new standard of care: • a systems storyline to fully acknowledge the heterogeneity of icc and to map and understand the many drivers and strategies behind the various models and practices that exist in integrated community care. • a participatory storyline to emphasize the importance of a shared vision, a strong narrative and the active involvement of all at the micro, meso and macro levels in communities and in society. • an implementation storyline to focus on the formulation of meaningful and effective guiding principles that can help icc to mature and become more robust in diverse contexts, amidst changing views and evolving challenges. the principles are intended to provide direction to those aiming to make icc a reality. the principles underpinning effectiveness adhere to the guide criteria: they help with guidance (priority setting), they have utility (i.e. they are actionable), they are inspiring (motivating people to 'walk the talk'), they are developmental (i.e. applicable to a range of contexts) and they are evaluable (i.e. you can document and judge the results). the seven effectiveness principles for integrated community care are set out below. these are grouped into three categories: the importance of authentic partnerships, the relevance of facilitating and enabling infrastructure and the dynamics of evaluation [3] : 1. value and foster the capacities of all actors in the community, including citizens, to become change agents and co-produce health and wellbeing. this requires the active involvement of all actors, paying special attention to the most vulnerable ones. 2. foster the creation of local alliances among all actors involved in the production of health and wellbeing in the community. develop a shared vision and common goals. actively work towards balanced power relations and mutual trust within these alliances. 3. strengthen community-oriented primary care that enhance people's capabilities to maintain health and/or to live in the community with complex chronic conditions. use people's life goals as the starting-point to define the desired outcomes of care and support. build resilient communities 4. improve the health of the population and reduce health disparities by addressing the social, economic and environmental determinants of health in the community and investing in prevention and health promotion. 5. support healthy and inclusive communities by providing opportunities to bring people together and by investing in both social care and social infrastructure. 6. develop the legal and financial conditions to enable the co-creation of care and support at the community level. monitor, evaluate and adapt 7. continuously evaluate the quality of care and support and the status of health and wellbeing in the community, using methods and indicators based on which are grounded within the foregoing principles and documented using a ' community diagnosis' involving all stakeholders, with wide participation. provide opportunities for joint learning. adapt policies, services and activities in accordance with the evaluation outcomes. the covid-19 crisis may be a turning-point. it is giving us a unique opportunity to acknowledge icc as a systemic approach that blurs boundaries between informal and formal care, between different skills in the workforce and between primary and specialist care. we call on all stakeholders and policymakers to work together to find inclusive and sustainable solutions that can move us towards 'icc 4all': ¬ by creating and supporting an international (research) community of changemakers, maintaining the impetus towards icc and driving progress. ¬ by avoiding competition between existing models, initiatives or 'brands', instead supporting existing knowledge, local movements and advocates. ¬ by providing structural funding so that countries and regions are supported through a transition phase. ¬ by facilitating place-based governance and accountability to a territorially defined population. ¬ by studying the practical aspects and opportunities involved in establishing local and neighbourhood trusts, so that public and private financing can be pooled at the local level. ¬ by establishing the role of primary care as the preferred point of access, gatekeeper and safety net for the community. ¬ by recognizing that icc is a societal process, not just a professional or managerial toolbox. the ongoing covid-19 pandemic has revealed the fragilities in key infrastructures and systems. a renewed emphasis on resilience creates opportunities for a more richly textured and locally sensitive health and social care system that plays to the strengths of citizens and communities and addresses social and environmental determinants of health [4] . the transform experience has already generated insights into a new paradigm that may bring fundamental benefits for all people, especially for under-served and marginalised groups. nevertheless, we must have patience with the slow pace of fast change. we believe in the power vandensande: starting the transition towards integrated community care 4all art. 18, page 3 of 3 of experimentation, in working continuously to build our evidence base and in ongoing enlargement of our learning coalition. covid-19-a pivotal moment in community care saving lives by european solidarity and cooperation in response to covid-19 integrated community care 4all. strategy paper to move icc forward. edited by philippe vandenbroeck and tom braes (shiftn) as result of an expert workshop on 28-29 goal-oriented care. a shared language and cocreative practice for health and social care. brussels: king baudouin foundation leading from the emerging future: from ego-system to eco-system economies cities reducing poverty: responding to covid-19 transform wishes to thank all participants who attended the brussels expert workshop (november 2019) for sharing their knowledge and expertise with us. special thanks also to transform's international community of practice, who are working tirelessly within the icc movement. their input has been crucial in bringing us this far.for more information, visit the website www.transformintegratedcommunitycare.com. this editorial is written on behalf of the transform partnership, an international forum intended to foster integrated community care in europe and beyond: https://transform-integratedcommunitycare.com. this paper underwent peer review using the cross-publisher covid-19 rapid review initiative. the author has no competing interests to declare. key: cord-013798-y8oy9tew authors: malik, ashish a.; swenson, tami; weihe, claudia; morrison, eric w.; martiny, jennifer b. h.; brodie, eoin l.; northen, trent r.; allison, steven d. title: drought and plant litter chemistry alter microbial gene expression and metabolite production date: 2020-05-22 journal: isme j doi: 10.1038/s41396-020-0683-6 sha: doc_id: 13798 cord_uid: y8oy9tew drought represents a significant stress to microorganisms and is known to reduce microbial activity and organic matter decomposition in mediterranean ecosystems. however, we lack a detailed understanding of the drought stress response of microbial decomposers. here we present metatranscriptomic and metabolomic data on the physiological response of in situ microbial communities on plant litter to long-term drought in californian grass and shrub ecosystems. we hypothesised that drought causes greater microbial allocation to stress tolerance relative to growth pathways. in grass litter, communities from the decade-long ambient and reduced precipitation treatments had distinct taxonomic and functional profiles. the most discernable physiological signatures of drought were production or uptake of compatible solutes to maintain cellular osmotic balance, and synthesis of capsular and extracellular polymeric substances as a mechanism to retain water. the results show a clear functional response to drought in grass litter communities with greater allocation to survival relative to growth that could affect decomposition under drought. in contrast, communities on chemically more diverse and complex shrub litter had smaller physiological differences in response to long-term drought but higher investment in resource acquisition traits across precipitation treatments, suggesting that the functional response to drought is constrained by substrate quality. our findings suggest, for the first time in a field setting, a trade off between microbial drought stress tolerance, resource acquisition and growth traits in plant litter microbial communities. drought is common in terrestrial ecosystems, and climate change is making drought more frequent and severe [1, 2] . mediterranean ecosystems like those in california, usa, that experience summer drought are particularly vulnerable to climate change through reduced winter precipitation and increased evapotranspiration that intensifies drought effects [3] . drought affects biogeochemical processes through mechanisms including limitations to resource diffusion and transport as well as organismal physiological responses to water stress [4] [5] [6] [7] . both mechanisms may cause a decline in growth and activity of microbial decomposers [6, 8] . as a direct effect of water limitation, microorganisms use their cellular machinery to maintain osmotic balance with the surrounding environment which involves intracellular accumulation of solutes or altering of the cell envelope to retain water [5, 6, 9, 10] . water limitation also affects microbial growth and survival indirectly by altering substrate transport and cellular motility [6] . selection based on these physiological adaptations influences microbial community composition through changes in taxa abundance and genetic variation [6, 11, 12] . still, we do not have a thorough understanding of the key physiological adaptations of in situ microbes to long-term drought. this knowledge gap introduces uncertainty in predictions of ecosystem processes under environmental change. long-term drought selects for stress tolerant microorganisms, and it also alters plant communities [13] and therefore plant litter chemistry that in turn can select for different microbial communities in the litter layer and the soil below [7, 12, 14, 15] . selection based on the chemical quality of litter substrates could affect community physiology related to resource acquisition (substrate discovery, breakdown and uptake) and will likely impact drought tolerance and overall fitness of populations in the community [12, 16] . thus, the indirect effects of drought via changes in plant litter chemistry could modify collective community physiology and therefore ecosystem process rates [7, 12] . an assessment of drought impact on microbial physiology and its biogeochemical implications must therefore also consider these indirect effects. the overall aim of this study was to identify the physiological responses to long-term drought in microbial communities on decomposing plant leaf litter-the surface layer of soil. we investigated the stress physiology of distinct litter communities in grassland and shrubland ecosystems undergoing field precipitation manipulation for a decade, with the drought treatment involving ã 40% reduction in annual precipitation that results in reduced decomposition rates [7] . the metabolism of the active microbial community was assessed using metatranscriptomics (community gene expression) and metabolomics (endo and exometabolites) to analyse community functional shifts in response to chronic drought stress. we hypothesised that exposure to 10 years of drought has led to greater microbial allocation to stress tolerance relative to growth pathways. in the absence of chronic stressful conditions like drought, microbial communities should divert fewer resources into stress tolerance and therefore more into growth. specifically, we hypothesised that (1) long-term drought causes increased gene expression and metabolite production associated with osmoprotection, dormancy and moisture retention mechanisms which leads to reduced growth; and (2) chemically diverse and complex shrub litter requires increased investment in resource acquisition pathways, further constraining microbial growth under drought. our results demonstrate multiple physiological signatures of drought stress and resource limitation in decomposing litter microbial communities. the study site is part of the loma ridge global change experiment situated near irvine, california, usa (33°44′n, 117°42′e, 365 m elevation). the climate is mediterranean with mean annual temperature of 17°c and mean annual precipitation of 325 mm. most precipitation falls between november and april, stimulating plant growth, and a summer drought lasts from may to october. the vegetation at the site includes annual grassland adjacent to coastal sage shrubland which correspond to the two litter types used in the experiment [7, 13] . the grassland plots (6.7 × 9.3 m) consisted of exotic annual grasses such as avena, bromus, and lolium and forbs such as erodium, whereas the shrub plots (18.3 × 12.2 m) consisted of crown-sprouting shrub species such as salvia mellifera, artemisia californica and malosma laurina. this shrub litter is known to have higher c:n ratio, higher proportion of lignin and other recalcitrant compounds and lower proportion of cellulose, hemicellulose and cell solubles than the grass litter [17] . for our experiment, we used a subset of plots with field precipitation manipulations that have been established since february 2007. reduced precipitation treatment involved~40% reduction in precipitation compared with ambient which was achieved by covering plots with clear polyethylene during a subset of rain events each winter. the design was replicated to have four plots per treatment (grassland ambient, grassland reduced, shrubland ambient and shrubland reduced) for a total of 16 plots. litter was collected in summer on 30 august 2017 from all four replicated plots within a treatment and homogenized by hand-mixing. note that litter from each treatment was kept separate. litter consisted of freshly fallen dry leaves in shrubland and dry senescing sheath and blade in grassland from leaf fall or grass senescence earlier in the year. intact shrub leaf litter was used, whereas grass sheath and blade were cut to a length of~10 cm. litter bags were made by placing 6 g dry litter mass into 15 cm × 15 cm bags made from 1 mm mesh window screen. bags were deployed on 12 september 2017. they were placed on top of the soil surface under the canopy. it was a particularly dry season and no substantial precipitation fell until december 2017. an in situ pulse wetting was performed on 30 november 2017 to simulate a discrete rainstorm of~13 mm using previously collected rainwater (fig. s1 ). litter bags were collected before wetting (sampling 1) and another batch of bags was collected the following day (sampling 2). there was no precipitation in the following days and therefore the litter dried to pre-wetting moisture levels (fig. s1 ). we collected another batch 12 days after wetting (sampling 3). the in situ wetting treatment was either too small or too short to elicit a wet-up response (figs. s2 and s3) [18] ; hence we chose not to focus on the effect of wet-up and drydown on microbial physiology but instead use all three sampling points to study the impact of vegetation type and long-term precipitation treatment on microbial community composition and physiology [12] . sixteen litter bags were sampled at each time point (two vegetation types × two precipitation treatments × four replicates). retrieved litter bags were immediately transported to the lab at room temperature. a subsample of leaf litter was ground in a mixer (a quick whirl for 5 s) and used for rna and metabolite extraction. we carried out rna extraction on a coarse-ground litter aliquot of 0.2 g for shrub and 0.5 g for grass using rneasy powersoil total rna kit following manufacturer instructions (qiagen, hilden, germany). due to a high amount of organic compounds co-extracted from shrub litter, a lower amount of starting material was used in the extraction protocol to increase the rna yield. after resuspending the rna pellet in solution sr7 in the final step, purity and concentration of total rna was assessed using a bioanalyzer 2100 (agilent, santa clara, ca, usa), qubit fluorometer (lifetechnologies, carlsbad, ca, usa) and nanodrop 2000 spectrophotometer (thermo scientific, usa). bioanalyzerderived abundances of 18s and 16s rrna in total rna extracts were used to calculate fungal:bacterial (f:b) ratios. 200-500 ng of total rna was used for subsequent steps. ribosomal rna was removed using a ribo-zero rrna removal kit (illumina, san diego, ca, usa) according to the manufacturer's instructions with a modification that included combining magnetic beads from the yeast and bacteria kit as follows: 0.5× yeast removal solution, 0.25× gram negative bacteria removal solution, and 0.25× gram positive bacteria removal solution. strand-specific and barcode indexed rna-seq libraries were then generated using the kapa rna-seq hyper kit (kapa biosystems, cape town, south africa) following the instructions of the manufacturer. the fragment size distribution of the libraries was verified via micro-capillary gel electrophoresis on a bioanalyzer 2100. resulting sequences from metatranscriptomic analysis were annotated with the metagenomics rapid annotation using subsystems technology (mg-rast) server version 4.0.3 [19] . functional classification was performed using the seed subsystems database and taxonomic annotations up to genus level were performed using the refseq database with a maximum e value cut-off of 10 −5 , minimum identity cut-off of 60% and minimum length of sequence alignment of 15 nucleotides. abundance tables derived from mg-rast (data s1) were imported into r for downstream analyses. some samples were excluded from further analyses as we either could not extract good quality rna (extraction from shrub litter was difficult) or the quality of sequences obtained was poor (due to poor quality rna or bad sequencing runs). number of replicates (n) for each treatment combination was: grass ambient sampling 1: 4, grass ambient sampling 2: 3, grass ambient sampling 3: 4, grass reduced sampling 1-3: 4, shrub ambient sampling 1: 4, shrub ambient sampling 2: 2, shrub ambient sampling 3: 3, shrub reduced sampling 1: 4, shrub reduced sampling 2: 2, and shrub reduced sampling 3: 3. coarse-ground leaf litter samples (1 g) were placed in 50 ml tubes with the addition of lc-ms grade water (20 ml, honeywell burdick & jackson, morristown, nj, usa). two extraction controls were included at this step by adding 20 ml of water to empty tubes. all samples were extracted for 1 h on an orbital shaker (orbital-genie, scientific industries, bohemia, ny, usa) at 200 rpm at 4°c followed by centrifugation for 15 min at 3220 × g at 4°c. supernatants (8 ml) were filtered through 0.45 um syringe filters (pall acrodisc supor membranes) into 15 ml tubes, frozen then lyophilized. dried extracts were resuspended in 1 ml lc-ms grade methanol (honeywell burdick & jackson, morristown, nj, usa) on ice, vortexed for 10 s, sonicated for 10 min in an ice bath and placed at 4°c overnight. samples were centrifuged for 15 min at 3220 × g at 10°c and further cooled at −20°c for 10 min. supernatants (850 µl) were transferred to 1.5 ml eppendorf tubes and dried down with a savant speedvac spd111v (thermo scientific, waltham, wa, usa) for 1 h with a final resuspension in ice-cold methanol containing internal standards (200 µl) and filtered through 0.22 µm centrifugal membranes (nanosep mf, pall corporation, port washington, ny, usa) by centrifuging at 10,000 × g for 5 min. samples (50 µl) were transferred to lc-ms vials for metabolomics analysis. extracts were analyzed using normal-phase lc-ms using a hilic-z column (150 mm × 2.1 mm, 2.7 μm, 120 å, agilent technologies, santa clara, ca, usa) on an agilent 1290 series uhplc. the two mobile phases for metabolite separation were 5 mm ammonium acetate in 0.2% acetic acid (a) and 95% acetonitrile with 5 mm ammonium acetate in 0.2% acetic acid (b) at a flow rate of 0.45 ml/min with the following gradient: 100% b for 1 min, decreased to 89% by 11 min, down to 70% by 15.75 min and 20% by 16.25 min, held until 18.5 min then back to 100% b by 18.6 min for a total runtime of 22.5 min. the column temperature was maintained at 40°c. ms data were collected on a thermo q exactive (thermo fisher scientific, waltham, ma, usa) and ms-ms data were collected using collision energies of 10-40 ev. metabolomics data were analyzed using metabolite atlas [20] with in-house python scripts to obtain extracted ion chromatograms and peak heights for each metabolite (data s2). metabolite identifications were verified with authentic chemical standards and validated based on three metrics (accurate mass <15 ppm, retention time within 1 min, and ms/ms fragment matching). data from internal standards and quality control samples (included throughout the run) were analyzed to ensure consistent peak heights and retention times. one sample from grass reduced precipitation treatment was lost during the extraction process, otherwise n = 4 for each treatment combination. rarefaction, ordination and diversity analyses of metatranscriptomics-derived functions and taxonomic units as well as metabolites were performed using the vegan package [21] , and nmds plots were generated using the ggplot2 package [22] under the r software environment 3.4.2 [23] . treatment effects were estimated using permutational multivariate analysis of variance (permanova) based on bray-curtis dissimilarity distance between samples with the r-vegan function adonis. shannon diversity index was calculated with rarefied functions and taxonomic units. two-way factorial anova and post hoc tukey honest significant differences tests were performed to ascertain the effect of treatments on functional and taxonomic α diversity. we used samples from three time points to measure the impact of vegetation type and long-term field precipitation manipulation on community physiology. the effect of reduced precipitation on the abundances of metatranscriptomics-derived functions at the upper level of seed subsystems classification was measured as the ratio of sum-normalised transcript abundance in level 1 classes in reduced and ambient precipitation treatments. one-way anova was used to ascertain if this effect was significant. we did not perform p value correction for multiple comparisons and kept the interpretation of shifts at level 1 classes to the minimum. to identify those transcripts that were significantly enriched in either reduced or ambient precipitation treatments in the two litter types, we used pairwise indicator species analysis as implemented within the r library labdsv [24] . the indval score for each transcript is the product of the relative frequency and relative average abundance within each treatment, and significance (p) was calculated through random reassignment of groups (1000 permutations). this indval score ranges from 0 to 1; maximum score of 1 for a transcript denotes that it is observed in all samples of only one treatment group. transcripts above a threshold indval score of 0.65 and with a p value smaller than 0.05 were considered significant (data s3). indval score was chosen to have enough stringency while also aiming to obtain a manageable and meaningful number of functional indicators. to identify vegetation-specific transcript indicators, we performed the indicator analysis on transcripts from ambient grass and ambient shrub treatments. we observed thousands of grass and shrub specific indicators. the threshold indval score for significance was raised to 0.7 for grass-shrub pairwise comparison to reduce the number of vegetation-specific indicators (data s4). the frequency of indicator transcripts in level 1 functional classes was obtained using the r plyr package [25] . metabolite abundances were visualised using the heatmap function in r. metabolites that were significantly higher in either ambient or reduced precipitation treatments across both litter types were identified using pairwise indicator species analysis as described above. here, we did not separate samples from grass and shrub litter in order to reduce choosing litter-specific plant-derived metabolites as indicators. metabolites above a threshold indval score of 0.6 and with a p value smaller than 0.05 were considered significant. a lower indval score was used here because a higher stringency gave very few indicators. correlations between metabolite abundances were performed to quantify the identified trade offs between traits related to growth and stress tolerance. we tested for negative bivariate correlations between significantly enriched metabolites in either reduced or ambient precipitation treatments across both litter types. correlation matrix visualization was done using ggcorrplot package in r [26] , separating samples from grass and shrub litter. pearson correlation coefficient was used as a measure of the linear dependence between metabolites. from this correlation analysis, we chose key relevant metabolites that represent the clusters of significantly enriched metabolites to further visualize the metabolic trade offs across and between treatments. these key metabolites were aspartic acid and adenosine (growth indicators), and ectoine and 5-oxoproline (stress indicators). the psych package in r [27] was used to obtain bivariate scatter plots with linear model fits, correlation coefficients (r) and p values denoting the strength of relationships among the representative metabolites, separately for samples from grass and shrub litter. multivariate ordination analysis of transcripts (at the level of function in subsystems classification) and metabolites suggested that the functional composition of communities did not differ across the three sampling points (fig. 1a, fig. 1 community functional and taxonomic diversity. two dimensional nmds ordination of (a) transcripts (function) and (b) metabolites. α diversity of (c) functions and (d) taxa derived from transcripts across vegetation and long-term precipitation treatments; n = 9-12. community fungal:bacterial (f:b) ratio (e) estimated as the ratio of mrna sequences assigned to fungi and bacteria; n = 9-12. a, b asterisks mark the significance of treatments that cause clustering of similar samples based on bray-curtis dissimilarity index analysed using permutational multivariate analysis of variance (perma-nova), and (c-e) asterisks mark the significance of differences between groups as analysed by tukey's multiple comparison test (***p < 0.001; **p < 0.01; *p < 0.05). sampling time did not significantly influence any parameter. permanova p > 0.05). results across the sampling points indicated that grass and shrub litter communities were functionally dissimilar (fig. 1a, b) . shrub litter communities demonstrated higher transcript functional α diversity than grass communities (fig. 1c) . in shrub litter, communities from reduced and ambient precipitation treatments shared more transcripts and metabolites than in grass communities where reduced precipitation clearly altered microbial physiology (fig. 1a, b) . transcript functional α diversity was similar in shrub communities from ambient and reduced precipitation treatments (fig. 1c) . however, we observed a higher functional diversity of transcripts in grass communities from reduced precipitation treatment in comparison to ambient (fig. 1c) . we used the taxonomic annotations of functional genes obtained from metatranscriptomics to ascertain the taxonomic α diversity and composition of the active litter microbial communities. bacteria and fungi comprised~97% of sequence reads. communities from shrub vegetation had significantly higher taxonomic α diversity of transcripts than grass communities (fig. 1d) . within each vegetation type, communities from ambient and reduced precipitation treatments differed taxonomically (figs. s4 and s5) , demonstrating a clear effect of long-term drought in shaping the taxonomic composition of the microbial community. taxonomic composition of communities did not differ across the sampling points (fig. s4) . fungi made up a large proportion of active communities in both grass and shrub vegetation. fungal:bacterial ratios obtained from transcript annotations as well as from ribosomal rna concentrations (bioanalyzer-derived 18s:16s rrna ratio) were higher in grass communities (figs. 1e and s6 ). relative abundance of fungi in communities was higher in grass litter under ambient precipitation compared with reduced precipitation (fig. 1e) . in shrub communities, there was no discernible shift in fungal:bacterial ratio in response to long-term precipitation treatment (fig. 1e ). we used community-aggregated traits (means of functional traits found in a given community [28] ) as a proxy to assess collective community physiology and its potential implications for ecosystem functioning. to identify traits that were unique to or significantly enriched in communities from either grass or shrub litter, we compared gene expression in communities from the two litter types under ambient precipitation treatment. the overall proportions of functions identified from metatranscriptomics were largely similar in communities from the two litter types (fig. 2a) . in total, 7141 subsystems functions were annotated (fig. 2b) . we observed nearly ten times the number of unique functions in shrub communities compared with grass communities using indicator analyses (fig. 2c, data s4 ). of the 182 functional indicators of grass communities, most belonged to the class protein metabolism (39 functions) and were linked to small and large subunit ribosomal protein synthesis as well as proteasome-mediated degradation of unneeded or damaged proteins [29] . on the contrary, we identified 1588 unique functions in shrub communities (fig. 2c) . the majority of functions unique to or enriched in shrub litter communities belonged to the class of carbohydrates (208 functions) and ranged from central carbohydrate metabolism to metabolism of mono-, di-and oligosaccharides, organic acids and sugar alcohols. in addition, 115 indicators of shrub litter communities were annotated to amino acid metabolism. the presence of a large number of functional indicators for carbohydrate and amino acid metabolism indicates increased investment in substrate degradation, uptake and assimilation in shrub communities. microbial communities in shrub litter may have increased investment in these resource acquisition traits to degrade the more chemically complex and diverse substrates. to uncover the physiological mechanisms that underlie microbial response to long-term drought, we analysed variable patterns in gene expression across the decade-long simulated precipitation treatments within each litter type. in grass communities, reduced precipitation caused systematic shifts in many functional classes (fig. 2d) . functional classes that were significantly higher in relative abundance under reduced precipitation treatment were membrane transport, iron acquisition and metabolism, phosphorus metabolism, stress response, dna metabolism, and cell division and cell cycle. classes with significantly lower relative abundance under reduced precipitation treatment compared with ambient were secondary metabolism, respiration and nitrogen metabolism. these shifts in functional classes imply higher expression of conventional housekeeping genes in grassland ambient than reduced precipitation treatment. however, in shrub communities there were only small, non-significant changes in abundances of these functional classes in response to the 10-year reduced precipitation treatment (fig. 2d) . drawing conclusions from shifts in upper-level classes of functions may be misleading because this level consists of myriad genes whose expression may decrease or increase in response to the environmental perturbation [30] . multiple genes belonging to the same class responding in opposite directions may cancel out resulting in no net effect for that class of functions. therefore, we also assessed shifts in expression of individual genes to identify those that were unique to or significantly enriched in communities from either ambient or reduced precipitation treatments. from the 7141 subsystems functions that were annotated in our dataset, in grassland communities we identified 665 transcript indicators of reduced precipitation treatment but only 87 indicators of ambient treatment (fig. 2e, data s3) . in shrub litter communities, we observed similar numbers of indicator transcripts in contrasting precipitation treatments, with 140 under ambient precipitation and 120 under reduced precipitation (fig. 2f, data s3) . the majority of transcript indicators of reduced precipitation treatment in grass litter communities could be directly or indirectly linked to physiological adaptations to moisture stress. in contrast, most of the indicators of ambient treatment (fig. 2e) belonged to common housekeeping functions (level 1 class carbohydrates: 21 functions). the highest number of transcript indicators of reduced precipitation in grass litter also belonged to the level 1 class of carbohydrates (fig. 2e, 105 functions) but represented functions linked to metabolism of mono-, diand oligosaccharides such as l-rhamnose, trehalose, maltose and maltodextrin, d-galacturonate, etc., and organic acids such as malonate. while some of these can be linked to conventional or alternative housekeeping functions, increased expression of genes linked to metabolism of sugars like trehalose suggests an adaptive mechanism of compatible solute accumulation to maintain cellular osmotic balance [5, 10, 31, 32] . a significant number of indicators of reduced precipitation in grass litter also belonged to the classes of membrane transport (47 functions) or stress response (41 functions) which were almost absent in the indicator profiles of ambient communities (fig. 2e) . membrane transport functions were mostly annotated to multi-subunit cation antiporters (na+ h+ antiporters), ton and tol transport systems, abc transporters and protein secretion systems. increased expression of genes for cation antiporters indicates a drought stress tolerance strategy of accumulating inorganic ions aimed at maintenance of cellular osmolarity [6, 9, 33] . in the level 1 class of stress response, we observed increased expression of genes related to uptake/ biosynthesis of choline, betaine and ectoine. these metabolites are widely-reported osmolytes in plants and microorganisms [6, 9, 10, 31, 34] and provide additional evidence for osmolyte accumulation as a stress tolerance mechanism in drought communities. we also observed enrichment of transcripts belonging to the cell wall and capsule class in communities from reduced precipitation in grass litter (43 functions, fig. 2e ). significant gene indicators here were linked to metabolism of capsular and extracellular polysaccharides (eps), gramnegative cell wall components (lipopolysaccharide assembly), and peptidoglycan biosynthesis demonstrating strategies either to retain water through capsular or eps "sponges", or to lower the permeability of cell walls to avoid water loss [6, 9, 32] . genes of the classes rna and protein metabolism that were significantly higher in reduced precipitation treatments were related to functions like transcription, rna processing, and protein synthesis/modification and were mostly of bacterial origin, whereas similar transcript indicators in ambient communities were mostly eukaryotic. this evidence links these functional indicators to drought-induced shifts in fungal:bacterial ratios of microbial communities (fig. 1e) [7] . a high number of functional indicators belonged to clusteringbased subsystems (84 functions, fig. 3c ) and miscellaneous (47 functions), but the majority of these were unassigned or putative functions that did not provide any clear functional insight. shrub litter communities were functionally more diverse than grass litter communities but precipitation treatment did not change the functional diversity (fig. 1a-c) . correspondingly, we observed a similar fig. 3 metabolite abundance across litter type and precipitation treatments. heatmap showing mean peak heights (n = 3-4) which relates to the abundance of metabolites that were significantly higher (p < 0.05) in either ambient or reduced precipitation treatments across both litter types. rows of metabolites are clustered vertically by level of enrichment in either ambient or reduced precipitation. number of unique functions across the contrasting precipitation treatments within shrub litter (fig. 2f) . unlike grass communities, very few distinctive stress response functions were identified in shrub communities under reduced precipitation treatment; these were linked to trehalose metabolism, oxidative stress and multi-subunit cation (na+ h+) antiporters. thus, the drought stress response physiology of microbial communities is variable and could depend on other traits like resource acquisition linked to litter chemistry. we next identified metabolites that were unique to or observed in higher abundance in either reduced or ambient fig. 4 distribution of metabolite abundance demonstrates metabolic trade offs. linear regression trends of representative growth indicators aspartic acid and adenosine, and stress indicators (osmolytes) ectoine and 5-oxo-proline in (a) grass and (b) shrub litter communities. these metabolites were the most relevant from among those that were significantly enriched in either ambient or reduced precipitation treatments (shown in fig. 3 ). numbers within each scatter plot are correlation coefficients (r) and asterisks denote the significance of the relationship across treatments (***p < 0.001; **p < 0.01; *p < 0.05; n = 23-24). precipitation treatments (figs. 3 and s7) . the results corroborated the patterns revealed using metatranscriptomics. most of the metabolites identified as indicators of precipitation treatment were monomeric compounds such as amino sugars, amino acids, ribonucleosides, and organic acids that are likely derived from living microorganisms. although plants also produce many of these compounds, plant-derived monomers would likely have been metabolized by litter microbes prior to our measurements [35, 36] . ectoine, which functions as a compatible solute to maintain internal water potential, showed greater abundance in the reduced precipitation treatment particularly in grass litter communities. 5-oxo-proline, choline and betaine are also potential osmolytes; these showed greater abundance in shrub litter communities under reduced precipitation treatment. on the contrary, in the grass litter under ambient precipitation treatment, various biogenic amino acids such as aspartic acid, and purine ribonucleosides such as adenosine and guanosine were enriched; these are molecular building-blocks of proteins and rna, respectively and indicate growth and biosynthesis. the abundance of these growth indicators was higher in the wet litter samples (sampling 2) relative to the drier (sampling 1 and 3) indicating increased activity under higher moisture content, while the abundance of stress indicators like ectoine and 5oxo-proline was higher in the dry samples (figs. 3 and s2) . this time-resolved pattern suggests that these metabolites are likely of microbial origin [18] . the differential metabolite profiles in contrasting precipitation treatments in grass communities corroborate the metabolic trade off between growth and water stress adaptations suggested by the transcriptomics data. consistent with metabolic trade offs, we observed 47 and 27 significant negative correlations between metabolite pairs (out of 378 tested) in grass and shrub litter communities, respectively (fig. s8) . in grass litter communities, we observed significant negative correlations between relevant growth indicators like aspartic acid and adenosine and drought stress indicators like ectoine (fig. 4) . in shrub litter communities, although we did detect slightly higher amount of osmolytes ectoine and 5-oxo-proline in the reduced precipitation treatment, there were no negative correlations between these drought stress indicators and the growth indicators (fig. 4 ). we found distinctive physiological signatures of microbial communities growing on plant leaf litter in response to simulated decade-long drought. given that natural rainfall was not observed or manipulated during our 2.5-month experiment, the differing gene expression and metabolite patterns across long-term precipitation treatments likely arose due to indirect legacy effects on microbial communities or litter chemistry driven by changes in plant communities [7, 12] . among these possibilities, the physiological differences more likely result from droughtinduced changes in microbial community composition and function [7, 37] . community shifts also suggest that environmental pressures selected for taxa that can survive the physiological stress imposed by drought [38] [39] [40] [41] . although drought-induced changes in plant litter chemistry may also cause physiological shifts in the microbial community [7, 12] , these differences were small enough (unpublished data) that they did not affect litter decomposition rates as demonstrated in a previous study at the same site [7] . for the first time in a field setting, our data demonstrate consistent expression of stress-response genes and production of related metabolites in microbial communities from plant litter in response to a history of drought. the most discernible physiological adaptation to drought was greater abundance of organic osmolytes that function to equilibrate osmotic potential between cells and their surroundings. we found some evidence that the flow of inorganic ions across the cell membrane is also regulated to maintain osmolarity. gene expression analysis of in situ communities suggests that various compatible solutes like ectoine, betaine, choline and trehalose were employed as osmolytes [6, 10, 31] . corroborating this inference, under reduced precipitation, we observed significantly higher concentrations of ectoine in grass litter communities and higher concentrations of choline and betaine in shrub litter communities. another significant physiological signature of drought was synthesis of capsule and eps that enable cells to form biofilms and retain water for longer periods in drier environments [6, 9, 42] . we also observed a significant increase in expression of genes linked to dormancy and sporulation in the grass reduced precipitation treatment, however only 3 out of 60 genes were identified as indicators of reduced precipitation treatment. these physiological changes likely reflect selection for microbial taxa with traits that confer a fitness advantage under drought. in ambient precipitation treatments, we observed more growth-related indicators which implies that under less stressful conditions, microbial communities divert fewer resources into stress tolerance and therefore grow better [5, 43] . our data demonstrate that physiological response to drought trades off against growth by diverting investment away from central metabolism and associated assimilatory pathways such as amino acid and nucleotide synthesis. physiological adaptation mechanisms like osmolyte accumulation can be energetically very expensive-by some accounts osmotic stress has been estimated to reduce growth yields by nearly 90% [5, 44] . such shifts in resource allocation can have big impacts on ecosystem c and n balance. to this end, increased stress investment in grass litter communities at the expense of growth may explain decreased decomposition under drought previously observed in the same field experiment [7] . although we observed a trade off between drought stress tolerance and growth traits in grass communities, shrub litter chemistry appears to alter these community-level trade offs. compared with grass, shrub leaf litter hosts a taxonomically and functionally more diverse decomposer community. despite this diversity, it is likely that lower chemical quality (higher c:n ratio, higher proportion of lignin and other recalcitrant compounds and lower proportion of cellulose, hemicellulose and cell solubles than the grass litter [17] ) makes shrub litter harder for microorganisms to degrade and imposes constraints on microbial physiology that affect stress tolerance strategies under drought. we also observed a high frequency and diversity of functional indicators of substrate degradation, uptake, and assimilation in shrub litter communities that may reflect the low resource quality. this high level of investment in resource acquisition traits in shrub litter communities may have affected their response to drought stress if there are trade offs between resource acquisition and stress tolerance traits. although such trade offs require further validation, they align with a recently-proposed theoretical framework that links ecosystem functioning with omicsderived traits of in situ microbial communities [16] . we aimed to assess the metabolite production of microbial communities in situ, but we cannot rule out that some persistent metabolites were produced by plants (e.g. phenolic compounds such as caffeic acid or nicotinic acid) or by mesofauna living on litter (e.g. carnitine or creatine). without more work on in situ metabolomics, it is difficult to separate microbial metabolites from other sources. still, the fast turnover of many monomeric metabolites and their correspondence with microbial gene expression gives us confidence that microbes produced some of the metabolites we discussed. going forward, these metabolites could be targeted for more sophisticated analyses of origin and fate. to conclude, 10 years of drought have altered microbial community composition and physiology. our results indicate that the metabolic costs of microbial stress tolerance to drought trade off against growth traits in drought-selected communities. in addition, litter of poor chemical quality constrains gene expression and metabolite production associated with drought stress tolerance. substrate quality and investment in resource acquisition traits can thereby alter the stress tolerance-growth trait relationship in microbial communities. the potential linkages of microbial traits with litter decomposition rates suggest that community-level trait trade offs have consequences for organic matter decomposition, a key ecosystem process. our data clearly identifies some of the physiological mechanisms of community-level adaptations to long-term drought and possible trade offs in stress tolerance, resource acquisition and growth. the authors declare that the data supporting the findings of this study are available within the article and its supplementary information file, and from the corresponding author on request. the transcriptomics data discussed in this publication have been deposited in ncbi's gene expression omnibus [45] and are accessible through geo series accession number gse148618 (https://www.ncbi.nlm.nih. gov/geo/query/acc.cgi?acc=gse148618). increasing drought under global warming in observations and models a drier future? unprecedented 21st century drought risk in the responses of soil microbial communities to water stress: results from a meta-analysis microbial stress-response physiology and its implications for ecosystem function life in dry soils: effects of drought on soil microbial communities and processes microbial abundance 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variability of soil moisture alter microbial community c and n resource use proline transport increases growth efficiency in salt-stressed streptomyces griseus gene expression omnibus: ncbi gene expression and hybridization array data repository author contributions aam, jbhm, elb and sda designed research; aam, cw, em and sda were involved in litter sampling, experimental setup and sample processing; aam performed the rna extractions; ts performed metabolite extraction and analysis; aam performed bioinformatic and statistical analyses; jbhm, elb and tn contributed reagents and analytical tools; aam drafted the paper and all authors were involved in critical revision and approval of the final version. conflict of interest the authors declare that they have no conflict of interest.publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.open access this article is licensed under a creative commons attribution 4.0 international license, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the creative commons license, and indicate if changes were made. the images or other third party material in this article are included in the article's creative commons license, unless indicated otherwise in a credit line to the material. if material is not included in the article's creative commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. to view a copy of this license, visit http://creativecommons. org/licenses/by/4.0/. key: cord-300356-oorac5he authors: nair, girish b.; niederman, michael s. title: community-acquired pneumonia: an unfinished battle date: 2011-10-05 journal: med clin north am doi: 10.1016/j.mcna.2011.08.007 sha: doc_id: 300356 cord_uid: oorac5he community-acquired pneumonia remains a common illness with substantial morbidity and mortality. current management challenges focus on identifying the likely etiologic pathogens based on an assessment of host risk factors, while attempting to make a specific etiologic diagnosis, which is often not possible. therapy is necessarily empiric and focuses on pneumococcus and atypical pathogens for all patients, with consideration of other pathogens based on specific patient risk factors. it is important to understand the expected response to effective therapy, and to identify and manage clinical failure at the earliest possible time point. prevention is focused on smoking cessation and vaccination against pneumococcus and influenza. have shown that patients with cap in a medicare population have a 1-year mortality of more than 40%, suggesting that pneumonia may be a surrogate marker of severe underlying comorbidity, or that it initiates a series of adverse consequences for some patients that leads to their eventual death. 7 despite the availability of different guidelines and treatment options, the economic burden associated with cap remains high at more than $17 billion annually in united states alone. 8 although most patients with cap are outpatients, the greatest portion of the cost for this illness is borne by those admitted to hospital, making the decision about admission an important one for several reasons. a recent study noted that decreasing the length of stay by 1 day in a patient with cap had a potential economic benefit of $2000. 9 with new health care reforms imminent and the emphasis on better health care delivery, cost-effective treatment of pneumonia will assume greater significance. there are several challenges with the management of cap, from the accurate diagnosis of lung infiltrates, decisions about the site of care, and the choice of appropriate antibiotics. the infectious disease society of america (idsa)/american thoracic society (ats) guideline from 2007 provides a summary of the approach to the treatment of cap directed mainly towards primary care physicians, hospitalists, and emergency medicine physicians. 1 multiple validated severity assessment scores have been developed that stratify patients according to the risk of death and can be used as decision support tools to guide site-of-care decisions. 10, 11 the emergence of drugresistant organisms, particularly drug-resistant streptococcus pneumoniae (drsp), is another challenge in disease management. biomarkers are increasingly being used to distinguish bacterial pneumonia from other causes and to help reduce the duration of antibiotic therapy. 12 this article reviews the recent advances in the diagnosis, management, and potential complications associated with cap. in cap, the major route of infection is microaspiration from a previously colonized oropharynx, but inhalation of suspended aerosolized microorganisms is the mechanism of infection for viruses, legionella, and tuberculosis. interactions between the host immune response, the virulence of the infecting organism, and the size of the inoculums determine whether a patient develops pneumonia. 13 defective cough, mucociliary clearance, and impaired local and humoral immunity predispose to severe pneumonia. alcohol consumption and smoking are independent risk factors for the development of pneumonia. medical comorbidities such as chronic obstructive pulmonary disease (copd), congestive heart failure, chronic kidney disease, liver disease, and immune deficiency states have an increased predisposition for the development of cap. recent use of proton pump inhibitor therapy started within 30 days has been identified as a risk factor for cap. 14 elderly patients are at increased risk for development of pneumonia and, when it occurs, they are more likely to die than younger individuals. 2 although many patients develop severe pneumonia because of immune impairment, others develop acute lung injury (acute respiratory distress syndrome [ards]) as a consequence of unilateral pneumonia because of an inability to localize the immune response to the initial site of infection, possibly because of the presence of a genetic variation in their immune responsiveness. 15, 16 the most common organism causing cap, in all patient populations, is s pneumoniae, or pneumococcus. other pathogens include hemophilus influenzae (particularly in cigarette smokers), moraxella catarrhalis, staphylococcus aureus (after influenza and recently in the form of methicillin-resistant s aureus [mrsa]), viruses (including influenza, respiratory syncytial virus, parainfluenza, and epidemic viruses), and atypical pathogens such as mycoplasma pneumoniae, chlamydophila pneumoniae, and legionella pneumophila. in most series, atypical pathogens are common, including in those admitted to the icu, where they can account for up to 20% of the identified pathogens. in addition, many investigators have documented that atypical pathogens may coexist with bacterial pathogens, accounting for their presence in up to 60% of patients with cap, when serologic testing is used. 17 gram-negative bacteria (pseudomonas aeruginosa, klebsiella pneumoniae, escherichia coli, enterobacter spp, serratia spp, proteus spp) are the causal agents in up to 10% of patients with cap, but may be more common in patients who develop pneumonia out of the hospital and have hcap risk factors. gram-negative bacteria have been associated with severe cap, and k pneumoniae was noted to be an independent risk factor for mortality in severe cap. 18 in one study from korea, in a multivariate analysis, the risk factors associated with gram-negative cap were septic shock (with an odds ratio of 4.1), cardiac disease, smoking, hyponatremia, and dyspnea, emphasizing the association of these organisms with severe illness. 19 enterobacter cap behaves more like hospital-acquired pneumonia and is associated with prolonged mechanical ventilation, delay in initiation of antibiotics, and longer icu stay. 20 risk factors for community-acquired p aeruginosa pneumonia include bronchiectasis, immunocompromised state, use of multiple courses of antibiotics, prolonged glucocorticoids in patients with copd, and recent hospitalization. 21 anaerobic organisms should be considered when aspiration is suspected. influenza is a common viral cause of cap, with a seasonal variation in frequency. primary influenza pneumonia tends to cause severe pneumonia, which can be either caused by the virus itself or a result of secondary bacterial infection with pneumococcus, s aureus, or h influenzae. high-risk patients include those with chronic heart or lung disease, diabetes, immunosuppression, hemoglobinopathy, renal disease, and otherwise healthy individuals more than 65 years of age. other viruses that cause cap include parainfluenza virus, respiratory syncytial virus (rsv), human metapneumovirus, severe acute respiratory syndrome virus, varicella, hantavirus, and adenovirus. many of these patients have viral infection as part of a mixed infection, often with bacterial pathogens. 22 emergence of drsp and community-acquired mrsa is a matter of concern that has complicated the empiric therapy choices for patients with cap. drsp is seen most often in patients older than 65 years of age, and in those with a history of alcoholism, antibiotic therapy within 3 months, multiple medical comorbid conditions, exposure to children in day care, or those with immune-compromised states. 23 community-associated mrsa (ca-mrsa) pneumonia occurs in patients with no prior health care exposure, usually after influenza, and may lead to a severe necrotizing pneumonia, although milder forms of illness have also been reported. 24 in patients with severe illness, the organism may produce a variety of exotoxins, including the panton-valentine leukocidin (pvl), which may contribute to lung necrosis. 25 multidrug resistance has been reported with ca-mrsa strains but, in general, these organisms are more drug sensitive than their hospital-acquired counterparts. 26 other less common causes of cap include mycobacterium tuberculosis, coxiella burnetii (q fever), burkholderia pseudomallei (melioidosis), chlamydophila psittaci (psittacosis), endemic fungi (histoplasmosis, coccidioidomycosis, blastomycosis), pasteurella multocida, bacillus anthracis, actinomyces israeli, francisella tularensis (tularemia), and nocardia spp. these organisms should be included in the differential diagnosis when evaluating a patient with cap, depending on the presence of specific risk factors that are noted in the clinical history. patients with cap usually present with an acute illness of 1 to 2 days duration. in those with intact immune response, systemic and respiratory symptoms such as cough, dyspnea, fever, and pleuritic chest pain predominate. fever and chills have a sensitivity of 50% to 85%, and dyspnea a sensitivity of 70% for the diagnosis of cap, whereas purulent sputum has a sensitivity of only 50%. 23 hemoptysis suggests necrotizing infection, such as lung abscess, tuberculosis, or gram-negative pneumonia, but is also a common finding, even in patients with bronchitis. in patients with disease and age-associated impairments in the immune response, the clinical presentation may be subtle, and involve primarily nonrespiratory findings. in the elderly, chest pain and cough may be absent in the early course of the disease, and fever and confusion may be the only symptoms. 23 other complaints such as lethargy, falling, poor oral intake, and decompensation of a chronic illness could also occur in patients with comorbid conditions and among the elderly. a good history and physical examination are essential for determining the possible causal agent and assessing the severity of illness, which in turn helps with management. risk factors for hcap, such as hospitalization or antibiotic therapy in the past 90 days, residence in a long-term care facility, chronic dialysis, outpatient wound care, or home infusion therapy, needs to be identified, because these patients are at risk for drug-resistant gram-negative organisms and s aureus. the history should identify risk factors for drsp and gram-negative organisms, as discussed earlier. it is also important to elicit recent travel history and exposure to birds, bats, farm animals, and rabbits ( table 1) . on physical examination, patients may have tachypnea, tachycardia, crackles, bronchial breath sounds, and findings of pleural effusion. clinicians should pay attention to other clues, such as relative bradycardia in relation to fever, which can be seen in infections caused by agents like legionella, chlamydophila, and mycoplasma. 27 mycoplasma can also cause cervical lymphadenopathy, arthralgia, and bullous myringitis. poor outcomes are noted in patients with a respiratory rate greater than 30 breaths/min, diastolic blood pressure less than 60 mm hg, systolic blood pressure less than 90 mm hg, heart rate greater than 125 beats/min, and temperature less than 35 c or greater than 40 c. 23 these clinical findings can be used to determine the risk of death, by incorporating them into prognostic scoring, using the pneumonia severity index (psi), the curb-65 criteria (a modification of the british thoracic society scoring system), or other tools (discussed later). other than raising clinical suspicion, no combination of symptoms and signs can accurately diagnose pneumonia in the clinical setting, and the definitive diagnosis requires a chest radiograph. 28 the clinical diagnosis has an overall sensitivity ranging from 70% to 90% and specificity between 40% and 70%. therefore, whenever there is suspicion of cap, a chest radiograph should be obtained for corroboration of the physical findings. 29 certain chest radiographic findings can also suggest more severe illness, including the presence of multilobar infiltrates, rapid progression of infiltrates, pleural effusion, and findings of necrotizing pneumonia. in the outpatient setting, extensive diagnostic testing is not routinely performed, because results are nonspecific, and antibiotic treatment should be initiated nair & niederman empirically. 1 even for inpatients, the value of diagnostic testing is limited and, when outcomes were compared using pathogen-directed therapy, compared with empiric therapy, there was limited benefit of testing. 30 in one prospective study of 262 patients from the netherlands, a pathogen was identified in 60% of cases. adequate sputum samples were obtained from only 44 patients, gram stain was diagnostic and confirmed by a positive sputum in 82%, urine pneumococcal antigen was positive in 54% of cases, blood cultures were positive in 16%, and bronchoscopic samples added benefit to diagnostic yield when sputum could not be expectorated. 31 in most studies, a specific causal diagnosis is obtained in less than 50% of patients with cap, even with extensive diagnostic testing, and the major focus of laboratory testing should be to assess severity of illness and allow early identification of the presence of pneumonic complications. white blood cell count may be normal on admission, and leukopenia is seen in patients with overwhelming pneumococcal pneumonia with sepsis and pneumonia caused by gram-negative organisms. 27 thrombocytosis and thrombocytopenia are associated with worse 30-day mortality in patients admitted with cap. 32 hyponatremia (<130 meq/l) is also associated with a poor outcome, if present on admission, in patients with cap. 33 the idsa/ats guidelines recommended testing for patients with pneumonia ( table 2) . radiographic evidence of lung infiltration provides a sensitive, but not specific, confirmation of community-acquired pneumonia. chest radiograph may show areas of consolidation, pleural effusion, lung abscess, necrotizing pneumonia, or multilobar illness. it may help in pattern recognition of the disease process: h influenzae has a peribronchial distribution of bronchopneumonia; s pneumoniae infection can have either lobar consolidation or bronchopneumonia; atypical pathogens may have an alveolar and interstitial pattern; aspiration most commonly involves the superior segment of the right lower lobe or the posterior segment of the right upper lobe; hematogenous dissemination follows the distribution of blood flow and may lead to bilateral nodular infiltrates. 27 cavitation or necrotizing pneumonia suggests infection with anaerobes, gram-negative bacteria, or s aureus, including mrsa. loculated effusion can be ruled out by decubitus film or computed tomography (ct). chest ultrasound is increasingly being used to assess the size, and to identify a safe site for sampling of pleural fluid. the usefulness of chest radiography is suboptimal in patients with very early infection, dehydration, severe granulocytopenia, structural changes such as with bullous emphysema, and in obese patients. it is reasonable to repeat a follow-up radiograph in 24 to 48 hours in patients who have had a negative initial finding, but have clinical signs of pneumonia. 1 there may be interobserver variability in chest radiographic interpretation of pneumonia. in a study that compared the readings of at least 2 radiologists, positive agreement (59%) was less frequent than negative agreement (94%). 34 ct has better sensitivity in diagnosing an infiltrate than chest radiography, but it is not routinely used, because there is a lack of evidence that use of ct scan improves outcomes. 35 sputum should be sent for gram stain and culture before starting therapy, but primarily in patients suspected of infection with drug-resistant or unusual pathogens. a good specimen contains no more than 10 squamous epithelial cells and more than 25 polymorphonuclear cells per low per field. the gram stain pattern on sputum can help with tailoring of antibiotics, particularly if it shows a pathogen that would not be treated routinely (such as clumps of gram-positive cocci, suggesting s aureus). the sensitivity of identifying s pneumonia is only 50% to 60% and specificity is greater than 80%. 27 it is less likely to have s aureus or gram-negative pneumonia in the absence of these organisms on gram stain of a good sputum sample, but this test is more valuable if positive than if negative. routine culture of expectorated sputum is not useful in the absence of an informative gram stain. the usefulness of realtime polymerase chain reaction testing of sputum samples has not been shown. culture can be obtained from intubated patients by collecting an endotracheal aspirate. a positive blood or pleural culture is seen in less than 20% of patients with pneumonia but, if present, helps with establishing the diagnosis. most positive cultures are of s pneumoniae. the idsa/ats guidelines recommend blood culture testing in patients admitted to icu, and in those with multiple other risk factors, including active alcohol abuse, liver disease, cavitatory lung disease, asplenia, leukopenia, and pleural effusion. these recommendations are based, in part, on the data from 13,043 medicare patients who showed that a true-positive blood culture was associated with no previous antibiotics, underlying liver disease, systolic blood pressure less than 90 mm hg, fever less than 35 c or greater than 40 c, pulse greater than 125 beats/ min, blood urea nitrogen greater than 10.71 mmol/l (30 mg/dl), serum sodium less than 130 mmol, and leukocyte count less than 5000 or greater than 20,000 cells/ ml. the diagnostic yield of blood cultures increased in patients with 1 or more risk factor and in those who had not received antibiotics before blood was collected. 36 urinary antigen testing (uat) is commercially available for detection of capsular polysaccharide of s pneumoniae and l pneumophilia serogroup 1. pneumococcal urinary antigen tests have a sensitivity of 50% to 80% and specificity of more than 90%. 37 the degree of positivity is correlated with the psi for s pneumoniae. 38 false-positive tests occur in patients who have had cap from pneumococcus within the previous 3 months. uat for legionella has a sensitivity of 70% to 90% and a specificity of up to 99% for detection of infection with serogroup 1, by far the commonest species to infect humans. 27 however, it does not detect other types of legionella, so a negative finding cannot rule out this infection. in one study, the use of uat for legionella had increased with time, leading to more diagnoses of serogroup 1 infection, but a decreased mortality from legionella, suggesting that urinary antigen testing was finding milder illness than had been recognized previously. 39 although one prospective study of 474 episodes of cap from spain found that s pneumoniae was diagnosed by urinary antigen test in 43.8% and helped physicians optimize antibiotic choice, 40 in general, it remains uncertain whether a positive result of any urinary antigen test changes cap management, or whether it is primarily of epidemiologic interest. serologic tests are of questionable importance in the initial setting, but are useful for the epidemiologic diagnosis of agents that are not readily cultured, although results are generally not available for weeks, and require the collection of both acute and convalescent serum samples. the diagnosis of most pathogens is based on acute and convalescent blood serologies showing a fourfold increase in immunoglobulin (ig) g obtained 2 to 6 weeks apart, which applies to c pneumoniae, c psittaci, q fever, and m pneumoniae. ig m antibodies start to increase in the acute phase and are useful in the early course of the disease. cold agglutinins are sometimes present in patients with m pneumoniae. nucleic acid amplification tests provide rapid test results in cap for atypical agents such as viruses, mycoplasma, chlamydophila, and legionella. polymerase chain reaction (pcr) assays were widely used for detecting influenza virus in the recent h1n1 epidemic. direct immunofluorescence or enzyme immunoassay are available for detection of viral antigens like influenza, rsv, adenovirus and parainfluenza viruses. the usefulness of pcr assays in managing cap has not been proven, and the concern with this method is that it is so sensitive that, if a respiratory sample is positive, it cannot distinguish colonization from infection unless the presence of a specific pathogen is itself diagnostic of infection (such as m tuberculosis). however, the test may be valuable if negative, because the absence of a suspected pathogen by pcr may permit a more focused antibiotic therapy approach. several newer biomarkers have been developed (midregional proadrenomedullin, midregional proatrial natriuretic peptide, proarginin-vasopressin, proendothelin-1, procalcitonin [pct], c-reactive protein [crp]) to identify patients with bacterial infection and to define the prognosis of cap. in one recent study, cardiac biomarkers, such as midregional proadrenomedullin, were better predictors of 28-day and 180-day mortality than inflammatory biomarkers such as pct. in that study, biomarkers correlated with disease severity and mortality, but did not help with causal diagnosis. 41 in another prospective study evaluating the relationship between biomarkers and icu admission, inflammatory biomarkers helped identify patients needing intensive care monitoring, including those requiring delayed icu admission. 42 the inflammatory biomarkers that have been studied most extensively are crp and pct, both of which are acute-phase reactants primarily produced by the liver in the presence of bacterial infection, but not viral illness. crp may identify which patients with acute respiratory symptoms have infectious pneumonia; levels are higher in patients who require hospitalization and in those with pneumococcal and legionella infection. 43 pct is a hormokine, produced in response to microbial toxins and certain host responses associated with bacterial infection, but inhibited by viral-related cytokines. serum levels tend to be high in patients with cap, who benefit from antibiotic therapy, and in those with an increased risk of death from cap. serial measurements of serum levels have also been used to define when antibiotics can be safely stopped in the presence of cap. 12, 44, 45 in one study of 302 patients with radiographic infiltrates and suspected cap, initiation of antibiotics and duration of therapy were determined by randomizing patients to management by an algorithm dictated by serial pct measurements versus management by clinical assessment. the pct-guided group had significantly fewer antibiotic prescriptions on admission and less antibiotic usage, and the duration of therapy was reduced from 12 to 5 days with similar clinical success. 46 one of the most important decisions in the management of pneumonia is to assess the severity of the disease, which can be used to predict mortality risk and may be nair & niederman a surrogate measure to define the site of care (outpatient, hospital ward, or icu). proper site-of-care decisions can have an impact on mortality, with several studies showing that delayed admission to the icu leads to a poor outcome. 47, 48 the most widely used prognostic scoring systems are the psi and the curb-65 score. in clinical practice, the psi is not widely used because it is complex and difficult to calculate a score. 49 in addition to these general scoring tools, some evaluations are designed to identify the need for icu admission, including the idsa/ats criteria for severe cap, and an australian method called the smart-cop, which is designed to predict the need for intensive respiratory or vasopressor support. other prediction rules are available and their clinical application varies widely. the psi was developed to identify patients with a low risk of dying who could be safely discharged home and receive outpatient treatment. the psi stratifies patients into 5 categories based on 30-day mortality, by using a scoring system based on 20 factors. it includes demographic characteristics, coexisting illnesses, physical examination findings, laboratory measurements, and radiographic finding. 50 patients in classes iv (30-day mortality risk of 4%-10%) and v (27% risk of death at 30 days) are usually admitted to the hospital and often to the icu. those in low-risk classes i and ii are often treated as outpatients, whereas it is a clinical judgment whether those in class iii should be hospitalized. the psi score includes age as an important determinant of point scoring and hence can overestimate the severity of illness in the elderly and in those with comorbidity. in one study of patients in psi class v, only approximately 20% needed icu admission, and these tended to be individuals who scored points based on acute illness features, and not on age and comorbid illness factors. 51 in contrast, the psi may underestimate severity of illness in young patients without comorbid illness, especially if their vital sign abnormalities are slightly less than the cutoffs used in the scoring system. 52 this was a particular problem during recent influenza epidemics that have involved primarily younger populations, in which psi scoring was not valuable for defining the need for icu admission. the curb-65 score from the british thoracic society is an easy scoring system to use, with the score (0-5) being defined (1 point each) by the presence of confusion, blood urea nitrogen greater than 7.0 mol/l (19.6 mg/dl), respiratory rate of 30 breaths/min or greater, systolic blood pressure less than 90 mm hg or diastolic blood pressure no greater than 60 mm hg, and age 65 years or older. patients with 2 of these criteria have a high enough risk of death that they should probably be admitted to the hospital, while those with 3 or more points should be considered for icu admission. modifications of this tool, without the laboratory measurement of blood urea nitrogen (crb-65) have also been found to be similarly accurate. 53 the limitation of this approach is its focus on assessment of only clinical parameters, such as vital signs, but without measurement of oxygenation or serial measurement of severity of illness after the initial hospital admission, and that it does not evaluate the presence of comorbid illness and its decompensation from baseline. 54 serum biomarkers can be used to supplement data obtained by prognostic scoring. 55 data from the german competence network for the study of community acquired pneumonia (capnetz) study group, showed that all new biomarkers were good predictors of short-term and long-term all-cause mortality and correlated with crb-65 score. 41 in other studies, low levels of pct were able to define patients at low risk of death regardless of findings using severity scoring. huang and colleagues 55 as well as kruger and colleagues 56 found, that even in patients identified as high risk using curb-65 or psi, a low pct value predicted a low chance of dying. 55, 56 severe cap scoring systems can also be used to help define which patients need icu care, identifying those with severe illness. the idsa/ats guidelines and the piro (predisposition, insult, response, and organ dysfunction) scoring system were developed to help define mortality risk in patients with severe pneumonia. according to the 2007 idsa/ats guidelines, severe cap is present if a patient needs invasive mechanical ventilation or requires vasopressors or has any 3 of 9 from the minor criteria listed later. liapakou and colleagues 57 found that patients meeting the major criteria needed icu admission, but those patients who had only minor criteria present had no increased mortality risk, regardless of how many criteria were met. more recently, brown and colleagues 58 found that both the positive and negative predictive value of minor criteria exceeded 80% if 4 criteria were used to define the need for icu admission rather than just 3 criteria. the piro score is calculated within 24 hours of icu admission, with 1 point given for each variable: comorbidities (copd, immunocompromise), age greater than 70 years, multilobar opacities on chest radiograph, shock, severe hypoxemia, acute renal failure, bacteremia, and acute respiratory distress syndrome. the maximum score that can be achieved is 8. patients are stratified into 4 levels of risk: (a) low, 0 to 2 points; (b) mild, 3 points; (c) high, 4 points; and (d) very high, 5 to 8 points. the piro score performed well as a 28-day mortality prediction tool in patients with cap requiring icu admission, with a better performance than apache ii and idsa/ ats criteria. 59 the smart-cop tool was developed to identify the need for intensive respiratory or vasopressor support (irvs), rather than a specific site-of-care decision. this tool uses a complex scoring system with the following values: low systolic blood pressure (<90 mm hg) (2 points), multilobar pneumonia (1 point), low albumin level (<3.5 g/dl) (1 point), high respiratory rate (25-30 breaths/min) (1 point), tachycardia (>125 beats/min) (1 point), confusion (1 point), poor oxygenation (2 points), and low arterial ph (<7.35) (2 points). when this method was used, the finding of a patient with a score of more than 3 points identified 92% of those needing irvs, with a specificity of 62.3%, whereas the psi and curb-65 did not perform as well for this 60 an algorithm for decision on site of care based on scoring system and treatment strategy is provided later (fig. 1) . early diagnosis and timely administration of antibiotics are associated with improved outcomes in patients with cap. 61, 62 although administration of therapy within 4 to 6 hours of arrival at the hospital can reduce mortality, it is important to only use antibiotics when the diagnosis is certain, because indiscriminate use of antibiotics in the absence of radiographic pneumonia has limited benefit and a real risk of community-acquired pneumonia antibiotic-associated adverse events, including drug-induced infectious diarrhea. according to idsa/ats guidelines, the first dose of antibiotic should be given in the emergency department, preferably within 4 to 6 hours of arrival, but no time period is specified. because no diagnostic testing can rapidly identify the causal pathogens in a patient with cap, initial therapy is empiric, based on an epidemiologic assessment of patient risk factors for specific pathogens. this assessment requires a careful history of patient comorbidity, recent antibiotic therapy history (within the past 3 months), and identification of pathogen-specific risk factors (see table 1 ; box 1). the idsa/ats guidelines recommend outpatient treatment with a macrolide or doxycycline for previously healthy adult patients with no risk factors for drsp. in patients with risk factors for drsp, a respiratory fluoroquinolone or a b-lactam antibiotic plus a macrolide or doxycycline is recommended. in choosing between these options, it is important to take a history about antibiotic usage in the past 3 months and to use an agent that is different from what has recently been used, because recent therapy may predispose to pneumococcal resistance to the agent used, rendering that therapy less effective. for patients admitted to the hospital, but not to the icu, an intravenous respiratory fluoroquinolone or a b-lactam plus a macrolide should be used. as mentioned earlier, the choice should be influenced by a history of which antibiotics have been used in the past 3 months, using agents from a different class, if possible. doxycycline is an in patients allergic to penicillin -respiratory fluoroquinolone plus aztreonam. if community-acquired mrsa is suspected vancomycin (and possibly clindamycin) or linezolid alone added to above regimen. if pseudomonas is suspected a b-lactam with activity against p aeruginosa (piperacillin-tazobactam, cefepime, imipenem, or meropenem) plus either ciprofloxacin or levofloxacin, or a b-lactam with activity against pseudomonas plus an aminoglycoside and azithromycin or a nonpseudomonal respiratory fluoroquinolone (moxifloxacin) alternative to a macrolide. ertapenem is an alternative to b-lactam agents such as cefotaxime, ceftriaxone, or ampicillin-sulbactam, and should be considered for patients with risk factors for infection with gram-negative pathogens other than p aeruginosa. all patients with cap should have routine therapy directed at pneumococcus and atypical pathogens, plus other organisms, as dictated by specific risk factors. the routine coverage for atypical pathogens is based on outcome studies that show that the addition of a macrolide to a b-lactam, or the use of a quinolone alone, leads to better outcome than b-lactam monotherapy. 1 in addition, some studies have shown a high frequency of atypical pathogen coinfection in patients with bacterial cap. current cap guidelines do not recommend monotherapy with any agent, including a quinolone, for patients with severe cap who are admitted to the icu. in patients with bacteremia (pneumococcal and other), atypical pathogen coverage with a macrolide (monotherapy or combination) improves mortality compared with treatment regimens with a quinolone, particularly quinolone monotherapy. 63, 64 combination therapy with a b-lactam and a macrolide has a survival advantage compared with quinolones alone in patients in the icu, and in the 1 prospective study that compared quinolone monotherapy with a b-lactam/quinolone combination therapy the monotherapy arm was not as effective. 65 in addition, in patients with pneumococcal bacteremia, especially in those with severe illness, the use of dual therapy (usually by adding a macrolide to a b-lactam) is associated with better outcome than with monotherapy, implying benefit from atypical pathogen coverage or from the antiinflammatory effect of the macrolide. 64 in a prospective study by rodriguez and colleagues 66 on 279 patients with cap and shock requiring vasopressors, combination therapy with either a b-lactam and a macrolide or a b-lactam and a quinolone had a 28-day survival advantage compared with monotherapy with a b-lactam or a quinolone alone. based on these data, in patients in the icu, an intravenous b-lactam plus either a macrolide or respiratory fluoroquinolone is recommended for patients without pseudomonal risk factors. in patients with risk factors for pseudomonal infection, an antipseudomonal b-lactam should be combined with either levofloxacin or ciprofloxacin, or the antipseudomonal b-lactam can be combined with both an aminoglycoside and either azithromycin or a respiratory quinolone. in patients allergic to penicillin, a respiratory fluoroquinolone should be used with aztreonam as an alternative regimen. when ca-mrsa is suspected, vancomycin or linezolid should be added to the other recommended agents. however, it may be necessary to add an anti-toxin producing agent, because part of the illness caused by ca-mrsa is mediated by bacterial exotoxin production. to stop toxin production, it may be necessary to add clindamycin to vancomycin, or to use linezolid alone. outpatients with mild-to-moderate cap are treated for 7 days or fewer with oral antibiotics, and therapy is stopped if they are afebrile and clinical features of pneumonia are resolving (cough, dyspnea, and sputum production). for inpatients, antibiotics are switched from intravenous to oral once the patient is afebrile for at least 2 occasions 8 hours apart, is able to take food by mouth, and there are clinical signs of improvement (in parameters such as cough, dyspnea, sputum production, oxygenation, and vital sign abnormalities), and this usually happens by the second or third hospital day. the switch to oral antibiotics can also be done for bacteremic patients, although it may take longer for these patients to reach clinical stability compared with nonbacteremic patients. 67 use of pct as a guide to decide on the duration of antibiotic use is supported by clinical trial data. 46 the duration of therapy should be a minimum of 5 days, providing that the patient is afebrile for 48 to 72 hours, there is no sign of community-acquired pneumonia extrapulmonary infection, the correct therapy was used initially, and the organism identified is not s aureus or p aeruginosa. with appropriate antibiotic treatment, most cases of cap resolve without complications. however, the treating physician should be alert to potential complications that, if not detected early, can lead to adverse outcomes. if the patient is responding well to therapy, no immediate follow-up radiograph is needed, and imaging is only done 4 to 6 weeks after discharge to define a new radiographic baseline. in most patients, the chest radiograph usually clears within 4 weeks, especially in patients younger than 50 years without underlying pulmonary disease or bacteremia. however, resolution may be delayed for 12 weeks or longer in older individuals and those with underlying lung disease and bacteremia. in about 15% of patients, there is a lack of response or clinical deterioration despite antibiotic therapy. the idsa/ats guidelines define early failure as progressive pneumonia or clinical deterioration, occurring in the first 72 hours of therapy, usually with respiratory failure or septic shock, and is a consequence of inappropriate antibiotic therapy or an incorrect initial diagnosis. later failure or nonresponse is often caused by a nosocomial infection, a disease-related or therapy complication, or a noninfectious process (eg, pulmonary embolism, inflammatory lung disease). if the patient has persistent fever, worsening dyspnea, unresolving pneumonia symptoms, and continued debility, a repeat radiograph should be done focusing on a broad differential diagnosis, including therapy for an unusual or drug-resistant pathogen (tuberculosis, endemic fungus, or a zoonosis), a pneumonic complication (empyema), an antibiotic complication (drug-induced colitis) or a nonpneumonic diagnosis (inflammatory lung disease, malignancy). diagnostic testing can include a chest ct scan, bronchoscopy, and, in some cases, open lung biopsy. organizing pneumonia is a complication of viral lung infection and other processes, and is characterized by fibroblast proliferation and diagnosed by a combination of radiographic findings, bronchoscopic lung biopsy, and the absence of ongoing infection. it is often managed with a therapeutic trial of steroids. the definitive investigation is an open lung biopsy. parapneumonic effusion and empyema are complications that can lead to apparent treatment failure. the chest radiograph shows an effusion, which should be sampled, and, if a low pleural fluid ph is present (<7.2 if previously healthy, but <7.3 if chronically ill) or if organisms are present, chest tube drainage and prolonged antibiotic therapy is required. a connection between the pleural space and the lung can develop and result in a bronchopleural fistula, which can be caused by erosion of the lung infection to the pleural surface. bronchopleural fistula is initially treated conservatively with antibiotics and a chest tube, but sometimes requires surgical repair. localized bronchiectasis can be a long-term sequela of cap, as a result of injury and dilation of the bronchus, and can be seen on ct scan of the chest. patients present with chronic productive sputum and recurrent infection on the same area. treatment is with postural drainage, antibiotics for exacerbation, and bronchodilators for coexisting airflow obstruction. recurrent pneumonia can occur after clinical and radiographic resolution of pneumonia. if it is present, whether it is in the same or a different area as the original infection should be determined. if it is in the same area, an anatomic problem (obstruction by tumor or foreign body) needs to be considered, whereas, if it is at another site, it may be the consequence of general immune impairment. the risk of this problem is higher in the elderly, those with a history of alcoholism, and in smokers. an underlying systemic immune deficiency should be ruled out by measuring quantitative ig levels. a detailed discussion of prevention is beyond the scope of this article. in the idsa/ats guidelines, the mainstay of prevention is pneumococcal and influenza vaccination for at-risk individuals, and provision of smoking cessation information to those smoking cigarettes at the time of pneumonia onset. 1 influenza vaccine is recommended during the appropriate season, for all persons aged 50 years or older, and for those with specific risk factors, including pregnant women and those with chronic heart, lung, metabolic, hematologic, or immune-compromising illnesses. pneumococcal polysaccharide vaccine should be given to all patients aged 65 years or older, and to younger patients with chronic heart or lung disease, asplenia, diabetes mellitus, and to residents of long-term care facilities. one revaccination after 5 years should be given to those with either a poor immune response or after age 65 years for those first immunized before the age of 65 years. in guidelines, and also in performance measures for hospitalized patients, vaccination should be given before discharge for all patients admitted with cap. infectious diseases society of america/american thoracic society consensus guidelines on the management of community-acquired pneumonia in adults management of community-acquired pneumonia: a review and update deaths: preliminary data for deaths: final data for 2006. national vital statistics reports 57. national center for health statistics2009 prognosis and outcomes of patients with community-acquired pneumonia. a meta-analysis global and local epidemiology of community-acquired pneumonia: the experience of the capnetz network pneumonia: 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outcomes, and value of severity predicting mortality in the elderly with communityacquired pneumonia: should we design a new car or set a new 'speed limit crb-65 predicts death from communityacquired pneumonia effects of delayed oxygenation assessment on time to antibiotic delivery and mortality in patients with severe community-acquired pneumonia risk prediction with procalcitonin and clinical rules in community-acquired pneumonia procalcitonin predicts patients at low risk of death from community acquired pneumonia across all crb-65 classes. eur respir severe community-acquired pneumonia: validation of the infectious diseases society of america/american thoracic society guidelines to predict an intensive care unit admission validation of the infectious disease society of america/american thoracic society 2007 guidelines for severe community-acquired pneumonia piro score for community-acquired pneumonia: a new prediction rule for assessment of severity in intensive care unit patients with community-acquired pneumonia smart-cop: a tool for predicting the need for intensive respiratory or vasopressor support in community-acquired pneumonia timing of antibiotic administration and outcomes for medicare patients hospitalized with community-acquired pneumonia quality of care, process, and outcomes in elderly patients with pneumonia antibiotics for bacteremic pneumonia: improved outcomes with macrolides but not fluoroquinolones combination antibiotic therapy lowers mortality among severely ill patients with pneumococcal bacteremia comparison of levofloxacin and cefotaxime combined with ofloxacin for icu patients with community-acquired pneumonia who do not require vasopressors combination antibiotic therapy improves survival in patients with community-acquired pneumonia and shock early switch from intravenous to oral antibiotics in hospitalized patients with bacteremic community-acquired streptococcus pneumoniae pneumonia key: cord-024571-vlklgd3x authors: kim, yushim; kim, jihong; oh, seong soo; kim, sang-wook; ku, minyoung; cha, jaehyuk title: community analysis of a crisis response network date: 2019-07-28 journal: soc sci comput rev doi: 10.1177/0894439319858679 sha: doc_id: 24571 cord_uid: vlklgd3x this article distinguishes between clique family subgroups and communities in a crisis response network. then, we examine the way organizations interacted to achieve a common goal by employing community analysis of an epidemic response network in korea in 2015. the results indicate that the network split into two groups: core response communities in one group and supportive functional communities in the other. the core response communities include organizations across government jurisdictions, sectors, and geographic locations. other communities are confined geographically, homogenous functionally, or both. we also find that whenever intergovernmental relations were present in communities, the member connectivity was low, even if intersectoral relations appeared together within them. other or are friends, know each other, etc." which generally refers to a social circle (mokken, 1979, p. 161) , while a community is formed through concrete social relationships (e.g., high school friends) or sets of people perceived to be similar, such as the italian community and twitter community (gruzd, wellman, & takhteyev, 2011; hagen, keller, neely, depaula, & robert-cooperman, 2018) . in social network analysis, a clique is operationalized as " . . . a subset of actors in which every actor is adjacent to every other actor in the subset (borgatti, everett, & johnson, 2013, p. 183) , while communities refer to " . . . groups within which the network connections are dense, but between which they are sparser" (newman & girvan, 2004, p. 69) . the clique and its variant definitions (e.g., n-cliques and k-cores) focus on internal edges, while the community is a concept based on the distinction between internal edges and the outside. we argue that community analysis can provide useful insights about the interrelations among diverse organizations in the ern. we have not yet found any studies that have investigated cohesive subgroups in large multilevel, multisectoral erns through a community lens. with limited guidance from the literature on erns, we lack specific expectations or hypotheses about what the community structure in the network may look like. therefore, our study focuses on identifying and analyzing communities in the 2015 middle east respiratory syndrome coronavirus (mers) response in south korea as a case study. we address the following research questions: (1) in what way were distinctive communities divided in the ern? and (2) how did the interorganizational relations relate to the internal characteristics of the communities? by detecting and analyzing the community structure in an ern, we offer insights for future empirical studies on erns. the interrelations in erns have been examined occasionally by analyzing the entire network's structure. for example, the katrina case exhibited a large and sparse network, 1 in which a small number of nodes had a large number of edges and a large number of nodes had a small number of edges (butts, acton, & marcum, 2012) . the katrina response network can be thought of as " . . . a loosely connected set of highly cohesive clusters, surrounded by an extensive 'halo' of pendant trees, small independent components, and isolates" (butts et al., 2012, p. 23) . the network was sparse and showed a tree-like structure but also included cohesive substructures. other studies on the katrina response network have largely concurred with these observations (comfort & haase, 2006; kapucu, arslan, & collins, 2010) . in identifying cohesive subgroups in the katrina response network, these studies rely on the analysis of cliques: "a maximal complete subgraph of three or more nodes" (wasserman & faust, 1994, p. 254) or clique-like (n-cliques or k-cores). the n-cliques can include nodes that are not in the clique but are accessible. similarly, k-cores refer to maximal subgraphs with a minimum degree of at least k. many cliques were identified in the katrina response network, in which federal and state agencies appeared frequently (comfort & haase, 2006; kapucu, 2005) . using k-cores analysis, butts, acton, and marcum (2012) suggest that the katrina response network's inner structure was built around a small set of cohesive subgroups that was divided along institutional lines corresponding to five state clusters (alabama, colorado, florida, georgia, and virginia), a cluster of u.s. federal organizations, and one of nongovernmental organizations. while these studies suggest the presence of cohesive subgroups in erns, we have not found any research that thoroughly discussed subsets of organizations' significance in erns. from the limited literature, we identify two different, albeit related, reasons that cohesive subgroups have interested ern researchers. in their analysis of cohesive subgroups using cliques, comfort and haase (2006) assume that a cohesive subgroup can facilitate achieving shared tasks as a group, but it can be less adept at managing the full flow of information and resources across groups and thus decreasing the entire network's coherence. kapucu and colleagues (2010) indicate that the recurrent patterns of interaction among the sets of selected organizations may be the result of excluding other organizations in decision-making, which may be a deterrent to all organizations' harmonious concerted efforts in disaster responses. comfort and haase (2006) view cliques as an indicator of " . . . the difficulty of enabling collective action across the network" (p. 339), 2 and others have adhered closely to this perspective (celik & corbacioglu, 2016; hossain & kuti, 2010; kapucu, 2005) . cohesive subgroups such as cliques are assumed to be a potential hindrance to the entire network's performance. the problem with this perspective is that one set of eyes can perceive cohesive subgroups in erns as a barrier, while another can regard them as a facilitator of an effective response. while disaster and emergency response plans are inherently limited and not implemented in practice as intended (clarke, 1999) , stakeholder organizations' responses may be performed together with presumed structures, particularly in a setting in which government entities are predominant. for example, the incident command system (ics) 3 was designed to improve response work's efficiency by constructing a standard operating procedure (moynihan, 2009 ). structurally, one person serves as the incident commander who is responsible for directing all other responders (kapucu & garayev, 2016) . ics is a somewhat hierarchical command-and-control system with functional arrangements in five key resources and capabilities-that is, command, operations, planning, logistics, and finance (kapucu & garayev, 2016) . in an environment in which such an emergency response model is implemented, it is realistic to expect clusters and subgroups to reflect the model's structural designs and arrangements, and they may be intentionally designed to facilitate coordination, communication, and collaboration with other parts or subgroups efficiently in a large response network. others are interested in identifying cohesive subgroups because they may indicate a lack of cross-jurisdictional and cross-sectoral collaboration in erns. during these responses, public organizations in different jurisdictions participate, and a sizable number of organizations from nongovernmental sectors also become involved (celik & corbacioglu, 2016; comfort & haase, 2006; kapucu et al., 2010; spiro, acton, & butts, 2013) . organizational participation by multiple government levels and sectors is often necessary because knowledge, expertise, and resources are distributed in society. participating organizations must collaborate and coordinate their efforts. however, studies have suggested that interactions in erns are limited and primarily occur among similar organizations, particularly within the same jurisdiction. that is, public organizations tend to interact more frequently with other public organizations in specific geographic locations (butts et al., 2012; hossain & kuti, 2010; kapucu, 2005; tang, deng, shao, & shen, 2017) . these studies indicate that organizations have been insufficiently integrated across government jurisdictions (tang et al., 2017) or sectors (butts et al., 2012; hossain & kuti, 2010) , and the identification of cliques composed of similar organizations reinforces such a concern. in our view, there is a greater, or perhaps more interesting, question related to the crossjurisdictional and cross-sectoral integration in interorganizational response networks: how are intergovernmental relations mixed with intersectoral relations in erns? here, we use the term interorganizational relations to refer to both intergovernmental and intersectoral relations. intergovernmental relations refer to the interaction among organizations across different government levels (local, provincial, and national) , and intersectoral relations involve the interaction among organizations across different sectors (public, private, nonprofit, and civic sectors). recent studies have suggested that both intergovernmental and intersectoral relations shape erns (kapucu et al., 2010; kapucu & garayev, 2011; tang et al., 2017) , but few have analyzed the way the two interorganizational relations intertwine. if the relation interdependencies in the entire network are of interest to ern researchers, as is the case in this article, focusing on cliques may not necessarily be the best approach to the question because clique analysis may continue to find sets of selected organizations that are tightly linked for various reasons. the analysis of cliques is a very strict way of operationalizing cohesive subgroups from a social network perspective (moody & coleman, 2015) , and there are two issues with using it to identify cohesive subgroups in erns. first, clique analysis assumes complete connections of three or more subgroup members, while real-world networks tend to have many small overlapping cliques that do not represent distinct groups (moody & coleman, 2015) . even if substantively meaningful cliques appear, they may not necessarily imply a lack of information flow across subgroups or other organizations' exclusion, as previous ern studies have assumed (comfort & haase, 2006; kapucu et al., 2010) . second, clique analysis assumes no internal differentiation in members' structural position within the subgroup (wasserman & faust, 1994) . in a task-oriented network such as an ern, organizations within a subgroup may look similar (e.g., all fire organizations). however, this does not imply that they are identical in their structural positions. when these assumptions in clique analysis do not hold, identifying cohesive subgroups as cliques is inappropriate (wasserman & faust, 1994) . similarly, other clique-like approaches (n-cliques and k-cores) demand an answer to the question: "what is the n-or k-?" the clique and clique-like approaches have a limited ability to define and identify cohesive subgroups in a task-oriented network because they do not clearly explain why the subgroups need to be defined and identified in such a manner. we proposed a different way of thinking about and finding subsets of organizations in erns: community. when a network consists of subsets of nodes with many edges that connect nodes of the same subset, but few that lay between subsets, the network is said to have a community structure (wilkinson & huberman, 2004) . network researchers have developed methods with which to detect communities (fortunato, latora, & marchiori, 2004; latora & marchiori, 2001; lim, kim, & lee, 2016; newman & girvan, 2004; yang & leskovec, 2014) . optimization approaches, such as the louvain and leiden methods, which we use in this article, sort nodes into communities by maximizing a clustering objective function (e.g., modularity). beginning with each node in its own group, the algorithm joins groups together in pairs, choosing the pairs that maximize the increase in modularity (moody & coleman, 2015) . this method performs an iterative process of node assignments until modularity is maximized and leads to a hierarchical nesting of nodes (blondel, guillaume, lambiotte, & lefebvre, 2008) . recently, the louvain algorithm was upgraded and improved as the leiden algorithm that addresses some issues in the louvain algorithm (traag, waltman, & van eck, 2018) . modularity (q), which shows the quality of partitions, is measured and assessed quantitatively: in which e ii is the fraction of the intra-edges of community i over all edges, and e ij is the fraction of the inter-edges between community i and community j over all edges. modularity scores are used to compare assignments of nodes into different communities and also the final partitions. it is calculated as a normalized index value: if there is only one group in a network, q takes the value of zero; if all ties are within separate groups, q takes the maximum value of one. thus, a higher q indicates a greater portion of intra-than inter-edges, implying a network with a strong community structure (fortunato et al., 2004) . currently, there are two challenges in community detection studies. first, the modular structure in complex networks usually is not known beforehand (traag et al., 2018) . we know the community structure only after it is identified. second, there is no formal definition of community in a graph (reichardt & bornholdt, 2006; wilkinson & huberman, 2004) , it simply is a concept of relative density (moody & coleman, 2015) . a high modularity score ensures only that " . . . the groups as observed are distinct, not that they are internally cohesive" (moody & coleman, 2015, p. 909 ) and does not guarantee any formal limit on the subgroup's internal structure. thus, internal structure must be examined, especially in such situations as erns. despite these limitations, efforts to reveal underlying community structures have been undertaken with a wide range of systems, including online and off-line social systems, such as an e-mail corpus of a million messages in organizations (tyler, wilkinson, & huberman, 2005) , zika virus conversation communities on twitter (hagen et al., 2018) , and jazz musician networks (gleiser & danon, 2003) . further, one can exploit complex networks by identifying their community structure. for example, salathé and jones (2010) showed that community structures in human contact networks significantly influence infectious disease dynamics. their findings suggest that, in a network with a community structure, targeting individuals who bridge communities for immunization is better than intervening with highly connected individuals. we exploit the community detection and analysis to understand an ern's substructure in the context of an infectious disease outbreak. it is difficult to know the way communities in erns will form beforehand without examining clusters and their compositions and connectivity in the network. we may expect to observe communities that consist of diverse organizations because organizations' shared goal in erns is to respond to a crisis by performing necessary tasks (e.g., providing mortuary and medical services as well as delivering materials) through concerted efforts on the part of those with different capabilities (moynihan, 2009; waugh, 2003) . organizations that have different information, skills, and resources may frequently interact in a disruptive situation because one type alone, such as the government or organizations in an affected area, cannot cope effectively with the event (waugh, 2003) . on the other hand, we also cannot rule out the possibility shown in previous studies (butts et al., 2012; comfort & haase, 2006; kapucu, 2005) . organizations that work closely in normal situations because of their task similarity, geographic locations, or jurisdictions may interact more frequently and easily, even in disruptive situations (hossain & kuti, 2010) , and communities may be identified that correspond to those factors. a case could be made that communities in erns consist of heterogeneous organizations, but a case could also be made that communities are made up of homogeneous organizations with certain characteristics. it is equally difficult to set expectations about communities' internal structure in erns. we can expect that, regardless of their types, sectors, and locations, some organizations work and interact closely-perhaps even more so in such a disruptive situation. emergent needs for coordination, communication, and collaboration also can trigger organizational interactions that extend beyond the usual or planned structure. thus, the relations among organizations become dense and evolve into the community in which every member is connected. on the other hand, a community in the task network may not require all of the organizations within it to interact. for example, if a presumed structure is strongly established, organizations are more likely to interact with others within the planned structure following the chain of command and control. even without such a structure, government organizations may coordinate their responses following the existing chain of command and control in their routine. we may expect to observe communities with a sparse connection among organizations. thus, the way communities emerge in erns is an open empirical question that can be answered by examining the entire network. several countries have experienced novel infectious disease outbreaks over the past decade (silk, 2018; swaan et al., 2018; williams et al., 2015) and efforts to control such events have been more or less successful, depending upon the instances and countries. in low probability, high-consequence infectious diseases such as the 2015 mers outbreak in south korea, a concerted response among individuals and organizations is virtually the only way to respond because countermeasures-such as vaccines-are not readily available. thus, to achieve an effective response, it is imperative to understand the way individuals and organizations mobilize and respond in public health emergencies. however, the response system for a national or global epidemic is highly complex (hodge, 2015; sell et al., 2018; williams et al., 2015) because of several factors: (1) the large number of organizations across multiple government levels and sectors, (2) the diversity of and interactions among organizations for the necessary (e.g., laboratory testing) or emergent (e.g., hospital closure) tasks, and (3) concurrent outbreaks or treatments at multiple locations attributable to the virus's rapid spread. all of these factors create challenges when responding to public health emergencies. we broadly define a response network as the relations among organizations that can act as critical channels for information, resources, and support. when two organizations engage in any mers-specific response interactions, they are considered to be related in the response. examples of interactions include taking joint actions, communicating with each other, or sharing crucial information and resources (i.e., exchanging patient information, workforce, equipment, or financial support) related to performing the mers tasks, as well as having meetings among organizations to establish a collaborative network. we collected response network data from the following two archival sources: (1) news articles from south korea's four major newspapers 4 published between may 20, 2015, and december 31, 2015 (the outbreak period), and (2) a postevent white paper that the ministry of health and welfare published in december 2016. in august 2016, hanyang university's research center in south korea provided an online tagging tool for every news article in the country's news articles database that included the term "mers (http://naver.com)." a group of researchers at the korea institute for health and social affairs wrote the white paper (488 pages, plus appendices) based on their comprehensive research using multiple data sources and collection methods. the authors of this article and graduate research assistants, all of whom are fluent in korean, were involved in the data collection process from august 2016 to september 2017. because of the literature's lack of specific guidance on the data to collect from archival materials to construct interorganizational network data, we collected the data through trial and error. we collected data from news articles through two separate trials (a total of 6,187 articles from the four newspapers). the authors and a graduate assistant then ran a test trial between august 2016 and april 2017. in july 2017, the authors developed a data collection protocol based on the test trial experience collecting the data from the news articles and white paper. then, we recollected the data from the news articles between august 2017 and september 2017 using the protocol. 5 when we collected data by reviewing archival sources, we first tagged all apparent references within the source text to organizations' relational activities. organizations are defined as "any named entity that represents (directly or indirectly) multiple persons or other entities, and that acts as a de facto decision making unit within the context of the response" (butts et al., 2012, p. 6) . if we found an individual's name on behalf of the individual's organization (e.g., the secretary of the ministry of health and welfare), we coded the individual as the organization's representative. these organizational interactions were coded for a direct relation based on "whom" to "whom" and for "what purpose." then, these relational activity tags were rechecked. all explicit mentions of relations among organizations referred to in the tagged text were extracted into a sociomatrix of organizations. we also categorized individual organizations into different "groups" using the following criteria. first, we distinguished the entities in south korea from those outside the country (e.g., world health organization [who], centers for disease control and prevention [cdc] ). second, we sorted governmental entities by jurisdiction (e.g., local, provincial/metropolitan, or national) and then also by the functions that each organization performs (e.g., health care, police, fire). for example, we categorized local fire stations differently from provincial fire headquarters because these organizations' scope and role differ within the governmental structure. we categorized nongovernmental entities in the private, nonprofit, or civil society sectors that provide primary services in different service areas (e.g., hospitals, medical waste treatment companies, professional associations). at the end of the data collection process, 69 organizational groups from 1,395 organizations were identified (see appendix). 6 we employed the leiden algorithm using python (traag et al., 2018) , which we discussed in the previous section. the leiden algorithm is also available for gephi as a plugin (https://gephi.org/). after identifying communities, the network can be reduced to these communities. in generating the reduced graph, each community appears within a circle, the size of which varies according to the number of organizations in the community. the links between communities indicate the connections among community members. the thickness of the lines varies in proportion to the number of pairs of connected organizations. this process improves the ability to understand the network structure drastically and provides an opportunity to analyze the individual communities' internal characteristics such as the organizations' diversity and their connectivity for each community. shannon's diversity index (h) is used as a measure of diversity because uncertainty increases as species' diversity in a community increases (dejong, 1975) . the h index accounts for both species' richness and evenness in a community (organizational groups in a community in our case). s indicates the total number of species. the fraction of the population that constitutes a species, i, is represented by p i below and then multiplied by the natural logarithm of the proportion (lnp i ). the resulting product is then summed across species and multiplied by à1: high h values represent more diverse communities. shannon's e is calculated by e ¼ h=ln s, which indicates various species' equality in a community. when all of the species are equally abundant, maximum evenness (i.e., 1) is obtained. while limited, density and the average clustering coefficient can capture the basic idea of a subgraph's structural cohesion or "cliquishness" (moody & coleman, 2015) . a graph's density (d) is the proportion of possible edges presented in the graph, which is the ratio between the number of edges present and the maximum possible. it ranges from 0 (no edges) to 1 (if all possible lines are present). a graph's clustering coefficient (c) is the probability that two neighbors of a node are neighbors themselves. it essentially measures the way a node's neighbors form a 1-clique. c is 1 in a graph connected fully. the mers response network in the data set consists of 1,395 organizations and 4,801 edges. table 1 shows that most of the organizations were government organizations (approximately 80%) and 20% were nongovernmental organizations from different sectors. local government organizations constituted the largest proportion of organizations (68%). further, one international organization (i.e., who) and foreign government agencies or foreign medical centers (i.e., cdc, erasmus university medical center) appeared in the response network. organizations coordinated with approximately three other organizations (average degree: 3.44). however, six organizations coordinated with more than 100 others. the country's health authorities, such as the ministry of health and welfare (mohw: 595 edges), central mers management headquarters (cmmh: 551 edges), and korea centers for disease control and prevention (kcdc: 253 edges), were found to have a large number of edges. the ministry of environment (304 edges) also coordinated with many other organizations in the response. the national medical center had 160 edges, and the seoul metropolitan city government had 129. the leiden algorithm detected 27 communities in the network, labeled as 0 through 26 in figures 1-3 and tables 2 and 3. the final modularity score (q) was 0.584, showing that the community detection algorithm partitioned and identified the communities in the network reasonably well. in real-world networks, modularity scores " . . . typically fall in the range from about 0.30 to 0.70. high values are rare" (newman & girvan, 2004, p. 7) . the number of communities was also consistent in the leiden and louvain algorithms (26 communities in the louvain algorithm). the modularity score was slightly higher in the leiden algorithm than the q ¼ 0.577 in the louvain. figure 1 presents the mers response network with communities in different colors to show the organizations' clustering using forceatlas2 layout in gephi. in figure 2 , the network's community structure is clear to the human eye. from the figures (and the community analysis in table 2 ), we find that the mers response network was divided into two sets of communities according to which communities were at the center of the network and their nature of activity in the response, core response communities in one group and supportive functional communities in the other. the two core communities (1 and 2) at the center of the response network included a large number of organizations, with a knot of intergroup coordination among the groups surrounding those two. these communities included organizations across government jurisdictions, sectors, and geographic locations ( table 2 , description) and were actively involved in the response during the mers outbreak. while not absolute, we observe that the network of a dominating organization had a "mushroom" shape of interactions with other organizations within the communities (also see figure 3a ). the dominant organizations were the central government authorities such as the mohw, the cmmh, and kcdc. the national health authorities led the mers response. other remaining communities were (1) confined geographically, (2) oriented functionally, or (3) both. first, some communities consisted of diverse organizations in the areas where two mers hospitals are located-seoul metropolitan city and gyeonggi province (communities 3 and 5). organizations in these communities span government levels and sectors within the areas affected. second, two communities consisted of organizations with different functions and performed supportive activities (community 4, also see figure 3b ). other supportive functional communities that focus on health (community 11, see figure 3c ) or foreign affairs (community 15) had a "spiderweb" shape of interactions among organizations within the communities. third, several communities consisted of a relatively small number of organizations connected to one in the center (communities 16, 17, 18, and 19) . these consisted of local fire organizations in separate jurisdictions (see figure 3d ) that were both confined geographically and oriented functionally. table 2 summarizes the characteristics of the 27 communities in the response network. in table 2 , we also note distinct interorganizational relations present within the communities. the two core response communities include both intergovernmental and intersectoral relations. 7 that is, organizations across government jurisdictions or sectors were actively involved in response to the epidemic in the communities. while diverse organizations participated in these core communities, the central government agencies led and directed other organizations, which reduced member connectivity. among the supportive functional communities, those that are confined geographically showed relatively high diversity but low connectivity (communities 3, 5, and 6 through 10). these communities included intergovernmental relations within geographic locations. secondly, communities of organizations with a specialized function showed relatively high diversity or connectivity. these included organizations from governmental and nongovernmental sectors and had no leading or dominating organizations. for example, communities 11 and 12 had intersectoral relations but no intergovernmental relations. thirdly, within each community of fire organizations in different geographic locations, one provincial or metropolitan fire headquarters was linked to multiple local fire stations in a star network. these communities, labeled igf, had low member diversity and member connectivity, while they were organizationally and functionally coherent. table 3 summarizes the results elaborated above. in addition to the division of communities along the lines of the nature of their response activities, we observe that the structural characteristics of communities with only intersectional or international relations showed high diversity and high connectivity. whenever intergovernmental relations were present in communities, however, the member connectivity was low, even if intersectoral relations appeared together within them. we use the community detection method to gain a better understanding of the patterns of associations among diverse response organizations in an epidemic response network. the large data sets available and increased computational power significantly transform the study of social networks and can shed light on topics such as cohesive subgroups in large networks. network studies today involve mining enormous digital data sets such as collective behavior online (hagen et al., 2018) , an e-mail corpus of a million messages (tyler, wilkinson, & buberman, 2005) , or scholars' massive citation data (kim & zhang, 2016) . the scale of erns in large disasters and emergencies is noteworthy (moynihan, 2009; waugh, 2003) , and over 1,000 organizations appeared in butts et al. (2012) study as well as in this research. their connections reflect both existing structural forms by design and by emergent needs. the computational power needed to analyze such large relational data is ever higher and the methods simpler now, which allows us to learn about the entire network. we find two important results. first, the national public health ern in korea split largely into two groups. the core response communities' characteristics were that (1) they were not confined geographically, (2) organizations were heterogeneous across jurisdictional lines as well as sectors, and (3) the community's internal structure was sparse even if intersectoral relations were present. on the other hand, supportive functional communities' characteristics were that (1) they were communities of heterogeneous organizations in the areas affected that were confined geographically; (2) the communities of intersectoral, professional organizations were heterogeneous, densely connected, and not confined geographically; and (3) the communities of traditional emergency response organizations (e.g., fire) were confined geographically, homogeneous, and connected sparsely in a centralized fashion. these findings show distinct features of the response to emerging infectious diseases. the core response communities suggest that diverse organizations across jurisdictions, sectors, and functions actually performed active and crucial mers response activities. however, these organizations' interaction and coordination inside the communities were found to be top down from the key national health authorities to all other organizations. this observation does not speak to the quality of interactions in the centralized top-down structure, but one can also ask how effective such a structure can be in a setting where diverse organizations must share authority, responsibilities, and resources. second, infectious diseases spread rapidly and can break out in multiple locations simultaneously. the subgroup patterns in response networks to infectious diseases can differ from those of location-bound natural disasters such as hurricanes and earthquakes. while some organizations may not be actively or directly involved in the response, communities of these organizations can be formed to prepare for potential outbreaks or provide support to the core response communities during the event. second, we also find that the communities' internal characteristics (diversity and connectivity) differed depending upon the types of interorganizational relations that appeared within the communities. based on these analytical results, two propositions about the community structure in the ern can be developed: (1) if intergovernmental relations operate in a community, the community's member connectivity may be low, regardless of member diversity. (2) if community members are functionally similar, (a) professional organization communities' (e.g., health or foreign affairs) member connectivity may be dense and (b) emergency response organization communities' (e.g., fire) member connectivity may be sparse. the results suggest that the presence of intergovernmental relations within the communities in erns may be associated with low member connectivity. however, this finding does not imply that those communities with intergovernmental relations are not organizationally or functionally cohesive. instead, we may expect a different correlation between members' functional similarity and their member connectivity depending upon the types of professions, as seen in 2(a) and (b). organizations' concerted efforts during a response to an epidemic is a prevalent issue in many countries (go & park, 2018; hodge, gostin, & vernick, 2007; seo, lee, kim, & lee, 2015; swaan et al., 2018) . the 2015 mers outbreak in south korea led to 16,693 suspected cases, 186 infected cases, and 38 deaths in the country (korea centers for disease control and prevention, 2015) . the south korean government's response to it was severely criticized for communication breakdowns, lack of leadership, and information secrecy (korea ministry of health and welfare, 2016). the findings of this study offer a practical implication for public health emergency preparedness and response in the country studied. erns' effective structure has been a fundamental question and a source of continued debate (kapucu et al., 2010; nowell, steelman, velez, & yang, 2018 ). the answer remains unclear, but the recent opinion leans toward a less centralized and hierarchical structure, given the complexity of making decisions in disruptive situations (brooks, bodeau, & fedorowicz, 2013; comfort, 2007; hart, rosenthal, & kouzmin, 1993) . our analysis shows clearly that the community structure and structures within communities in the network were highly centralized (several mushrooms) and led by central government organizations. given that the response to the outbreak was severely criticized for its poor communication and lack of coordination, it might be beneficial to include more flexibility and openness in the response system in future events. we suggest taking advice from the literature above conservatively because of the contextual differences in the event and setting. this study's limitations also deserve mention. several community detection methods have been developed with different assumptions for network partition. some algorithms take deterministic group finding approaches that partition the network based on betweenness centrality edges (girvan & newman, 2002) or information centrality edges (fortunato et al., 2004) . other algorithms take the optimization approaches we use in this article. in our side analyses, we tested three algorithms with the same data set: g-n, louvain, and leiden. the modularity scores were consistent, as reported in this article, but the number of communities in g-n and the other two algorithms differed. the deterministic group finding approach (g-n) found a substantively high number of communities. the modularity score can help make sense of the partition initially, but the approach is limited (reichardt & bornholdt, 2006) . thus, two questions remain: which algorithm do we choose and how do we know whether the community structure is robust (karrer, levina, & newman, 2008) ? in their nature, these questions do not differ from which statistical model to use given the assumptions and types of data in hand. the algorithms also require further examination and tests. while we reviewed the data sources carefully multiple times to capture the response coordination, communication, and collaboration, the process of collecting and cleaning data can never be free from human error. it was a time-consuming, labor-intensive process that required trial and error. further, the original written materials can have their own biases that reflect the source's perspective. government documents may provide richer information about the government's actions but less so about other social endeavors. media data, such as newspapers, also have their limitations as information sources to capture rich social networks. accordingly, our results must be interpreted in the context of these limitations. in conclusion, this article examines the community structure in a large ern, which is a quite new, but potentially fruitful, approach to the field. we tested a rapidly developing analytical approach to the ern to generate theoretical insights and find paths to exploit such insights for better public health emergency preparedness and response in the future. much work remains to build and refine the theoretical propositions on crisis response networks drawn from this rich case study. the katrina response network consisted of 1,577 organizations and 857 connections with a mean degree except for the quote, comfort and haase (2006) do not provide further explanation incident command system was established originally for the response to fire and has been expanded to other disaster areas in the end, we found that the process was not helpful because of the volume and redundancy of content in news articles different newspapers published, which is not an issue in analysis because it can be filtered and handled easily using network analysis tool. because we had not confronted previous disaster response studies that collected network data from text materials, such as news articles and situation reports, and reported their reliability we also classified organizations based on specialty, such as quarantine, economy, police, tourism, and so on regardless of jurisdictions. twenty-seven specialty areas were classified. we note that the result of diversity analysis using the 27 specialty areas did not differ from that using the 69 organizational groups. the correlation of the diversity indices 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respiratory syndrome coronavirus structure and overlaps of communities in networks author biographies yushim kim is an associate professor at the school of public affairs at arizona state university and a coeditor of journal of policy analysis and management. her research examines environmental and urban policy issues and public health emergencies from a systems perspective jihong kim is a graduate student at the department of seong soo oh is an associate professor of public administration at hanyang university, korea. his research interests include public management and public sector human resource management he is an associate editor of information sciences and comsis journal. his research interests include data mining and databases her research focuses on information and knowledge management in the public sector and its impact on society, including organizational learning, the adoption of technology in the public sector, public sector data management, and data-driven decision-making in government jaehyuk cha is a professor at the department of computer and software, hanyang university, korea. his research interests include dbms, flash storage system the authors appreciate research assistance from jihyun byeon and useful comments from chan wang, haneul choi, and young jae won. the early idea of this article using partial data from news articles was presented at the 2019 dg.o research conference and published as conference proceeding (kim, kim, oh, kim, & ku, 2019) . data are available from the author at ykim@asu.edu upon request. we used python to employ the leiden community detection algorithm (see the source code: https://github.com/ vtraag/leidenalg). network measures, such as density and clustering coefficient, as well as the diversity index were calculated using python libraries (networkx, math, pandas, nump). we used gephi 0.9.2 for figures and mendeley for references. the authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. the authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: this work was supported by the national research foundation of korea grant funded by the korean government (ministry of science and ict; no. 2018r1a5a7059549). supplemental material for this article is available online. key: cord-018038-gqdylj6n authors: snyder, william m.; wenger, etienne title: our world as a learning system: a communities-of-practice approach date: 2010 journal: social learning systems and communities of practice doi: 10.1007/978-1-84996-133-2_7 sha: doc_id: 18038 cord_uid: gqdylj6n we live in a small world, where a rural chinese butcher who contracts a new type of deadly flu virus can infect a visiting international traveller, who later infects attendees at a conference in a hong kong hotel, who within weeks spread the disease to vietnam, singapore, canada, and ireland. fortunately, the virulence of the severe acute respiratory syndrome (sars) was matched by the passion and skill of a worldwide community of scientists, health care workers, and institutional leaders who stewarded a highly successful campaign to quarantine and treat those who were infected while identifying the causes of the disease and ways to prevent its spread. in such a world, we depend on expert practitioners to connect and collaborate on a global scale to solve problems like this one – and to prevent future ones. as global citizens. what does it mean to 'think globally and act locally'? does global stewardship primarily imply building international organisations that address social and environmental issues to compensate for the economic focus of global corporations? is such a global perspective sufficient to address issues that are essentially local? how can we connect the power and accessibility of local civic engagement with active stewardship at national and international levels? what are the design criteria for such a system and what might it look like? we believe there are three fundamental design criteria that help specify essential characteristics of a world learning system capable of addressing the scope and scale of the global challenges we face today. problems such as overpopulation, world hunger, poverty, illiteracy, armed conflict, inequity, disease, and environmental degradation are inextricably interconnected. moreover, they are complex, dynamic, and globally distributed. to address such challenges, we must increase our global intelligence along several dimensions: cognitive, behavioural, and moral. we must increase, by orders of magnitude, our societal capacity for inquiry; our ability to continuously create, adapt, and transfer solutions (churchman, 1971) . a world learning system that can match the challenges we face must meet three basic specifications: • action-learning capacity to address problems while continuously reflecting on what approaches are working and why -and then using these insights to guide future actions. • cross-boundary representation that includes participants from all sectors -private, public, and nonprofit -and from a sufficient range of demographic constituencies and professional disciplines to match the complexity of factors and stakeholders driving the problem. • cross-level linkages that connect learning-system activities at local, national, and global levels -wherever civic problems and opportunities arise. civic development is essentially a social process of action learning, in which practitioners from diverse sectors, disciplines, and organisations work together to share ideas and best practices, create new approaches, and build new capabilities. the full potential of this learning process is only realised when it connects all the players at various levels who can contribute to it. there are a number of organisations -including the united nations, the world bank, and an array of nongovernmental organisations such as doctors without borders, the world council of churches, oxfam international, major foundations, and many others -whose mission is to address worldwide problems. but these organisations typically focus on solving the manifestations of problems -eliminating land mines from war-torn regions or reducing the incidence of aids, for instance. given the urgency of these problems, it is understandable that these organisations do not focus on the underlying learning capacity of a city or country. while it is essential to address these and other urgent problems on their own terms, our society's longterm capacity to solve them at both local and global levels will nevertheless require step-change increases in our foundational capacity for intelligent social action. what is the nature of large-scale learning systems that can operate at local and global levels? how can we take steps to create such learning systems? to what extent can they be designed and what does design even mean in such a context? these learning challenges are among our world's most urgent as we find ourselves today in a race between learning and self-destruction. fortunately, we have examples of transformative, inquiry-oriented learning systems in hundreds of private-sector organisations, with a growing number in public and nonprofit organisations as well -at both organisational and interorganisational levels. strong, broad-based secular forces are driving this movement. most organisations today, including domestic firms as well as multinationals, have been forced to confront large-scale learning issues to compete in the knowledge economy. there is much we can learn from the experience of organisations about how to increase our society's collective intelligence. the most salient lesson is that managing strategic capabilities primarily entails supporting self-organising groups of practitioners who have the required knowledge, use it, and need it. we call these groups 'communities of practice' to reflect the principle that practitioners themselves -in active collaboration with stakeholders -are in the best position to steward knowledge assets related to their work. a well-known private-sector example of such practitioner stewardship is the network of 'tech clubs' that chrysler engineers formed in the early 1990s (see wenger et al., 2002, chapter 1) . the company had just reorganised its product-development unit into 'car platforms' focused on vehicle types (small cars, large cars, minivans, etc.). design engineers with specialties related to the various vehicle components -such as brakes, interior, and windshield wipers -organised communities of practice to foster knowledge sharing across car platforms. the cross-boundary sharing of these communities was a critical success factor for the reorganisation. we are now seeing a proliferation of organisations fostering the development of communities of practice across industry sectors, geographic locations, and various elements of the value chain. communities of practice are not new. they have existed since homo sapiens evolved 50,000 years ago, 1 but organisations have now become increasingly explicit about cultivating these communities. distinctive competencies in today's markets depend on knowledge-based structures that are not restricted by formal affiliation and accountability structures. the most distinctive, valuable knowledge in organisations is difficult or impossible to codify and is tightly associated with a professional's personal identity. developing and disseminating such knowledge depends on informal learning much more than formal -on conversation, storytelling, mentorships, and lessons learned through experience. this informal learning, in turn, depends on collegial relationships with those you trust and who are willing to help when you ask. informal learning activities and personal relationships among colleagues are the hallmarks of communities of practice. hence, we see an increasing focus on informal community structures whose aggregate purpose is to steward the learning of an organisation and its invaluable knowledge assets. communities of practice have three basic dimensions: domain, community, and practice. a community's effectiveness as a social learning system depends on its strength in all three structural dimensions. • domain. a community of practice focuses on a specific 'domain,' which defines its identity and what it cares about -whether it is designing brakes, reducing gun violence, or upgrading urban slums. passion for the domain is crucial. members' passion for a domain is not an abstract, disinterested experience. it is often a deep part of their personal identity and a means to express what their life's work is about. • community. the second element is the community itself and the quality of the relationships that bind members. optimally, the membership mirrors the diversity of perspectives and approaches relevant to leading-edge innovation efforts in the domain. leadership by an effective 'community coordinator' and core group is a key success factor. the feeling of community is essential. it provides a strong foundation for learning and collaboration among diverse members. • practice. each community develops its practice by sharing and developing the knowledge of practitioners in its domain. elements of a practice include its repertoire of tools, frameworks, methods, and stories -as well as activities related to learning and innovation. the activities of a community of practice differ along several dimensionsface-to-face to virtual; formal to informal; public to private. further, activities are orchestrated according to various rhythms -for instance, in one community, listserv announcements come weekly, teleconferences monthly or bi-monthly, projects and visits occur when an opportunity presents itself, back-channel e-mails and phone calls are ongoing; and the whole group gathers once or twice a year face-to-face (see fig. 7 .1). these activities form an ecology of interactions that provide value on multiple levels. beyond their instrumental purpose of creating and sharing knowledge, they increase the community's 'presence' in members' lives and reinforce the sense of belonging and identity that are the foundation for collective learning and collaborative activities. communities of practice do not replace more formal organisational structures such as teams and business units. on the one hand, the purpose of formal units, such as functional departments or cross-functional teams, is to deliver a product or service and to be accountable for quality, cost, and customer service. communities, on the other hand, help ensure that learning and innovation activities occur across formal structural boundaries. indeed, a salient benefit of communities is to bridge established organisational boundaries in order to increase the collective knowledge, skills, and professional trust of those who serve in these formal units. for instance, at daimlerchrysler, brake engineers have their primary affiliation with the car platform where they design vehicles. yet they also belong to a community of practice where they share ideas, lessons learned, and tricks of the trade. by belonging to both types of structure, they can bring the learning of their team to the community so that it is shared through the organisation, and, conversely, they can apply the learning of their community to the work of their team. pioneering, knowledge-intensive organisations have recognised that beyond the formal structures designed to run the business lies a learning system whose building blocks are communities of practice that cannot be designed in the same manner as formal, hierarchical structures. communities of practice function well when they are based on the voluntary engagement of members. they flourish when they build on the passions of their members and allow this passion to guide the community's development. in this sense, communities of practice are fundamentally self-governed. our experience suggests, however, that while communities do best with internal leadership and initiative, there is much that organisations can do to cultivate new communities and help current ones thrive. the intentional and systematic cultivation of communities cannot be defined simply in terms of conventional strategy development or organisational design. rather, sponsors and community leaders must be ready to engage in an evolutionary design process whereby the organisation fosters the development of communities among practitioners, creates structures that provide support and sponsorship for these communities, and finds ways to involve them in the conduct of the business. the design of knowledge organisations entails the active integration of these two systems -the formal system that is accountable for delivering products and services at specified levels of quality and cost, and the community-based learning system that focuses on building and diffusing the capabilities necessary for formal systems to meet performance objectives. it is crucial for organisational sponsors as well as community leaders to recognise the distinct roles of these two systems while ensuring that they function in tandem to promote sustained performance. the fundamental learning challenges and nature of responses in business and civic contexts are very similar. the size, scope, and assets of many businesses create management challenges that rival those of large cities, or even small countries. in both cases, one needs to connect practitioners across distance, boundaries, and interests in order to solve large-scale problems. organisations have found that communities of practice are extremely versatile in complementing formal structures. they are known for their ability to divide and subdivide to address hundreds of domains within and across organisations; they lend themselves to applications where scalability, broad scope, and the need for extensive, complex linkages are relevant. hence there is much we can learn from the early, highly developed business examples. the approaches for building largescale learning systems in organisations -by combining both formal and informal structures -provide a blueprint for thinking about how to build such systems in the messy world of civil society. communities of practice already exist in the civic domain, where they complement place-based communities as well as the ecology of formal organisations, including businesses, schools, churches, and nonprofits. in the civic arena as well as in organisations, our challenge is not to create communities of practice so much as to foster them more systematically. our analysis of societal learning systems -whether at local, national, or international levels -focuses on cities (which we define as an entire metropolitan region) as highleverage points of entry for a number of reasons. for one, as of the year 2000, there are more humans on the planet living in cities than outside them. in 2002, there were twenty megalopolises in the world with more than 10 million people, and by 2015 there will be nearly forty. cities have always been the font of new ideas, new applications of technologies, new cultural movements, and social change. they constitute natural nodes in a network for disseminating innovations. in the problems they face and the opportunities they offer, they also provide a microcosm of the world. finally, cities possess an organisational infrastructure and established leadership groups with the potential to see the value and to sponsor the design of a local learning system. in many cities, multisector coalitions or alliances are formed to take on a pressing issue such as improving urban schools, increasing access to low-income housing, cleaning up a business district, or building a stadium, park, or cultural facility (see grogan and proscio, 2000) . these coalitions, however, generally do not take sustained responsibility for stewarding a civic domain or for bringing together the full array of stakeholder constituencies to identify and address short-and long-term priorities. one way to assess the level of civic stewardship in any city or region is to map the prevalence, inclusiveness, and effectiveness of civic communities of practice (also known as coalitions, associations, partnerships, and alliances, among other terms) who take responsibility for clusters of issues related to particular civic domains, such as education, economic development, health, housing, public safety, infrastructure, culture, recreation, and the environment. the reality is that in many cities these domains have no explicit stewardship, or they are left to public agencies the city as a learning system: stewarding the 'whole round' of civic domains or to a menagerie of disparate, often competitive and conflicting organisations that carve out small pieces of the puzzle -regarding housing availability, for examplebut do not coordinate efforts or leverage a common base of expertise and resources. the city, re-imagined as a learning system, consists of a constellation of crosssector groups that provide stewardship for the whole round of civic domains (see fig. 7.2) . cultivating a learning system at the city level means taking stock of the current stewardship capacity in the city and accounting for the array of civic disciplines and the quality of active communities of practice stewarding them. this city-level assessment provides a template for what a nation can do. at the nation level, leaders might evaluate a representative sample of major cities and regions as a baseline assessment of its civic stewardship capacity. by extension, an evaluation of the top 500 strategic cities in the world could provide a benchmark for our civic learning capacity at a global level. at the national and global levels, the analysis also considers the strength and quality of linkages across cities both within and across nations. of course, even at the city level, there are subsectors and neighbourhoods that are fractal elements of the city, each with its own whole round of civic practices, and among which neighbourhood-to-neighbourhood linkages are as instrumental as ones that connect cities and nations. a city-based initiative to promote economic development in chicago provides an example of an effort designed to leverage communities as agents of civic development. 2 in 1999, the city of chicago established a cross-sector coalition, the mayor's council of technology advisors, to create 40,000 new high-tech jobs in the chicagoland region. the coalition leaders began by pulling together a group of forty-five civic leaders to brainstorm ways to achieve this goal. according to a study commissioned before the group met, the greatest challenge they faced was encouraging business development in high-tech industries such as telecommunications and biotech. a related challenge was cultivating local sources of seed capital for start-ups in these industries. the result of the group's first meeting was a slate of long-and short-term initiatives -including the introduction of technology in schools; encouraging young women and minorities to explore technology careers; and building a stronger digital infrastructure in the city, especially in underserved areas. several of the groups focused on initiatives specific to the industry sectors identified in the initial study: telecommunications, software development, biotech, venture capital, and emerging areas such as nanotechnology. the industry groups were particularly successful in this initiative, largely because they were able to coalesce communities specific to development challenges in each industry sector. the civic leaders in chicago understood that coalescing communities of practice -in this case, along industry lines -was the foundation for building relationships, generating ideas, and catalysing business initiatives. as one leader put it, 'our first objective was to create communities, period. the technology industries were fragmented without a sense of commonality. for example, we have more software developers than in silicon valley, but here it's only 9% of the workforce. so we started getting people connected and networked and building a sense of community in our high-tech sectors.' the chicago biotech network (cbn) is one of the more mature high-tech communities in chicago and provides an illustration of the influence and stewardship such a community can have over time. cbn started as a grassroots group that held about five seminars a year for diverse constituents interested in biotech developments. at first, it was more for individuals interested in life sciences. then companies (such as abbott laboratories and baxter, two fortune 500 pharmaceuticals located in the chicago area), started to attend the meetings as well, and they brought different perspectives. over time, the community came to include scientists, university deans, lawyers, venture capitalists, angel investors, city and state business development staff, and others. anywhere from twenty-five to two hundred people showed up at the meetings, which were held at various places and sponsored by members. these gatherings provided an opportunity for members to discuss science and industry trends and build relationships. one of the leaders summarised the community's evolution: 'early on, people mostly came for the personal value of networking and discussing ideas. now the domain of the community is to promote science and business development in the biotech sector in the chicago area. we focus on science ideas, business development know-how, and knowledge transfer processes.' offshoots of community activities include targeted events that link scientists, angel investors, and large pharmaceuticals to fund biotech startups that can commercialise promising innovations coming out of university labs. on a broader level, the community has helped increase biotech lab space in the city, lobbied at state and federal levels for increased research funding, and recruited biotech companies to locate in chicagoland. the leader of the chicago-based biotech community estimated the value of the community's activities for generating start-ups and, by extension, job creation in the region: 'i can't point to anything specific, but our events have brought structure to the interface between r&d scientists and the venture community; and we've gone from very little venture funding to the point where we now have $50 million coming to various biotech companies this year.' the chicago biotech network illustrates how an industry-based community of practice can serve as a powerful force for civic development. in this case, the focus was on economic development, but the key point is that strong stewardship of civic issues, even in the hard-nosed area of industry development, depends on vital communities of practice. the purpose of the communities was not only to provide professional development and networking opportunities but also to cultivate thriving high-tech industries in chicagoland. these communities advocated for their domain as a strategic focus for the city, built relationships among community members from various backgrounds, and shared know-how among practitioners. finally, as one community leader stated, they worked to serve the city they loved, and ultimately their children, who would inherit their civic legacy. communities of practice can also provide powerful stewardship for civic issues at the national level by connecting innovative civic groups across cities. the safecities community, for example, was organised in march 1999 by vice president al gore's reinventing government initiative to reduce gun violence in the united states. the announcement of the safecities community coincided with publication of the fbi's crime-rate statistics, which showed significant variation across cities in injuries and fatalities caused by gun violence. senior executives in the national partnership for reinventing government (npr) office began by convening officials from relevant agencies and developing a shared vision for what the network would be about and how they would work together. they sent out an invitation to cities and regions nationwide and selected ten coalitions to participate in the safecities communitybased on criteria that included multisector collaboration, a track record of innovation, and commitment to improved results. these local coalitions provided stewardship for public safety issues in their cities as did the industry-focused communities in chicago. a striking characteristic of the initiative was that it offered participants no funding -the value of participation was to get connected, to learn, and to enhance the capacity to reduce gun violence. the scale of the initiative was also distinctiveconnecting civic coalitions from across the nation for the purpose of sharing ideas, collaborating on innovation initiatives, and helping to shape policy at local, state, and federal levels. 3 the safecities community can be described in terms of the three structural dimensions of communities of practice. each of the coalition members was focused, broadly speaking, on issues related to the domain of public safety. their specific domain targeted a subdomain within this area -defined as reducing injuries and fatalities due to gun violence. the specificity of this domain was crucial for coalescing a community with overlapping interests, focusing its learning activities, and attracting sponsors. the community was composed of members at local and national levels and from various disciplines and constituencies, such as officials from the fbi, the bureau of alcohol, tobacco, firearms and explosives, and an assortment of divisions within the justice department at the national level; and mayors, police chiefs, faith leaders, hospital and social workers, school principals, neighbourhood activists, and district attorneys at the local level. finally, the practice of safecities members included community policing strategies, after-school programs, crimemapping methods, prosecutorial strategies, the design of local gun-possession laws, and ways to improve the interaction between at-risk youth and law-enforcement professionals. after a couple of preliminary teleconferences, safecities was launched at a faceto-face meeting in washington, d.c., explicitly billed as a community-of-practice launch. the sponsors and community coordinating team (based in the npr office) posed three basic questions for the group to address during the 2-day conference: what is safecities about (domain)? who is part of safecities (community)? what does safecities do (practice)? the conference included opportunities for members to meet informally, including an evening reception and knowledge-sharing 'fair'. a nationally renowned police chief from highpoint, north carolina, gave a talk about his city's success at reducing gun violence through both rehabilitation and enforcement efforts that focused on the city's most violent individuals. (he was so impressed with the gathering that he asked npr officials if his coalition could join, and they agreed to make his group an honorary member.) during the conference, members outlined a design for how they would learn together -including teleconferences, visits, a website, and other activities. the issues they identified became topics for their biweekly teleconferences. the conference was instrumental in coalescing members around a shared agenda and building trust and reciprocity. the safecities teleconferences subsequently became more active and members were more forthcoming about selecting topics and offering to speak to the group about their experiences. fostering 'community' -a sense of mutual trust, shared identity, and belonging -took on more prominence as an important structural element that made safecities successful. one of the outcomes of the initial conference illustrates the value of network participation for members. after hearing the highpoint police chief talk about his success, groups from ft. wayne, indiana and inkster, michigan -including police chiefs, mayors, and faith leaders from both cities -visited highpoint and observed programs in action. both coalitions then adapted the highpoint model for their own locales with coaching from highpoint. safecities operated successfully from march 1999 until june 2002, spanning the transition from a democratic to a republican administration. political appointees from both parties, as well as senior civil servants in the justice and treasury departments (where the sponsorship was primarily based) believed in the crosslevel, cross-sector approach that safecities embodied. sponsors were impressed to see such active participation on the part of senior civic leaders, even though they received no government funding for participating. these local leaders felt strongly about the value safecities provided -in terms of ideas, access to expertise, and opportunities for national visibility and influence based on local success. agency sponsors ultimately decided to close the safecities community in favour of a more conventional federal program. the decision confused many of the participants, given the minimal federal costs associated with the initiative, principally the cost of funding the community's full-time coordinator (a junior staff person, albeit a talented leader) and intermittent attention by agency champions. the coordinator's role was particularly important -arranging speakers for teleconferences, documenting insights on the website, arranging peer-to-peer visits, and coordinating with state and federal officials. the loss of the coordinator and agency attention was a fatal blow to the community. in its place, the us justice department enacted a new program, called safeneighborhoods, which provided funding for local initiatives such as after-school programs. the program managers intended to build on the safecities foundation, but they did not appreciate the distinctive characteristics of the community -opportunities for peer-to-peer learning and collaboration across cities, sectors, and levels of government. while safecities members were glad that the government was providing new funds to support local initiatives, they passionately argued that such funding could never substitute or compensate for the value of the safecities community. the safecities story thus validates the power of cross-city communities of practice while highlighting a key challenge: how to educate senior leaders with the power to sponsor such initiatives -from public, private, or nonprofit sectors (including foundations). these and other questions about starting, sustaining, and scaling such initiatives must be addressed for communities to succeed at local, national, and international levels. at the international level there are a myriad of professional groups and organisations that focus on global civic issues. in recent years a number of these have developed a stronger emphasis on peer-to-peer learning and innovation among members from diverse disciplines. the ayuda urbana initiative was started in conversations about developing municipal capabilities between world bank urban specialists and several mayors of capital cities in the central american and caribbean region. they recognised the value of connecting with peers across borders to address problems and challenges that all cities in the region face. a group of ten cities decided to participate in the initiative: guatemala city, havana, managua, mexico city, panama city, san josé, san juan, san salvador, santo domingo, and tegucigalpa. the people involved in the project include the mayors and their staff in each of the ten cities. additional partners include the world bank, which provides overall coordination, some regional organisations to provide local legitimacy, and the british and dutch governments to provide funding. 4 the project was to create a constellation of communities of practice that would take advantage of the knowledge available in the participating cities. the domains would focus on a challenge of urban development and management the cities shared, including e-government, urban upgrading, environmental sanitation, municipal finances, urban transportation, renovation of historical city centres and poverty alleviation, and disaster prevention and management. the communities would consist of urban specialists in each domain from the participating cities and from local organisations. together they would build their practice by comparing experiences and sharing resources across cities, with input from world bank experts about what had been learned elsewhere. the communities of practice were officially launched through a series of 2-day workshops, each focused on one of the topics. each workshop brought together specialists from the participating cities as well as a few world bank experts. the purpose of the workshops was to • create an initial forum to develop relationships and trust through face-to-face interactions among participants • provide an opportunity for each participating city to share its experience • engage participants in a discussion of lessons learned based on presentations by world bank experts • establish a prioritised list of the most pressing issues and most frequently asked questions • introduce web-based tools for use in facilitating an ongoing learning process and train participants to use the system • choose a person to coordinate the collection of resources to be shared via e-mail and the web site. the project has created an interactive website, available to the public, which serves as a repository for the various communities of practice. the site includes a library of resources, downloadable manuals, bibliographic references, and proceedings of meetings. in addition, the site hosts an online forum to give participants the opportunity to discuss issues, ask questions, share relevant information, and stay in touch. for example, a community member asked how to price waste management services. another member from san salvador responded with a posting that explained how his city determined the price of such services. the ayuda urbana initiative illustrates the value of collaboration across borders to address urgent issues in urban development, and it raises salient issues common to international communities. creating communities of practice among cities from different countries is not all that different from similar efforts within a country, but there is additional complexity. the regional focus of ayuda urbana meant that participants spoke the same language and shared a cultural context. the situation would have been more complex if the project had expanded beyond the region. another issue is the role of the convener when members do not share the same national government. sponsorship has to come from an organisation like the world bank, which can appreciate the vision of cross-border communities and the subtleties involved in cultivating such communities. indeed, ayuda urbana represents the latest development of a broader initiative at the world bank to focus on knowledge as a key lever in the fight against poverty. the bank started an initiative in 1998 to support the development of communities internally, and since then the number of communities has grown from twenty-five to more than a hundred -and the influence of several has been considerable. an external study of the communities found that they were the 'heart and soul' of the bank's new strategy to serve its clients as a 'knowledge bank.' the ayuda urbana initiative highlights the importance of a skilled convener who is committed to a community-based approach as a way to address societal challenges. in this case, the world bank is applying the same knowledge strategy with client countries that it has been applying internally. indeed, the bank's experience in cultivating communities of practice was critical to the success of the ayuda urbana project. the result is a new model for facilitating knowledge development among countries. experts at the bank consider it their task not just to provide their knowledge to clients but to build communities of practice among them as a way to develop their capabilities. the bank experts still have a role to play, but not in a one-way transfer. instead, their contribution takes place in the context of a community of practice that emphasises peer-to-peer learning. this approach models a shift in the traditional relationship between sources and recipients of knowledge. cultivating civic learning systems involves many of the challenges that organisations face in cultivating internal learning systems, but many of these become amplified in the civic context. the domains are especially complex; the communities tend to be very diverse; and the practices involve different disciplines, varied local conditions, and less well-defined opportunities to work together on projects. but perhaps the greatest challenge is the scale required for civic learning systems to leverage their full potential and match the scale of the problems they address. how do you significantly increase the scale of a community-based learning system without losing core elements of its success -identification with a well-defined domain, close personal relationships, and direct access to practitioners for mutual learning? the principle to apply is that of a fractal structure (see gleich, 1987; wheatley, 1994) . in such a structure, each level of substructure shares the characteristics of the other levels. applying such a design principle, it is possible to preserve a small-community feeling while extending a system from the local to the international level. local coalitions such as the chicago biotech network and each of the safecities partners created a local focus of engagement that made it possible for members to participate in broader networks at national and international levels. the idea is to grow a 'community of communities' in which each level of sub-communities shares basic characteristics: focal issues, values, and a practice repertoire. each dimension of a community of practice provides opportunities for the constitution of a fractal learning system. fractal domain. in many cases, domains may start more broadly and eventually subdivide as members discover nuances and opportunities to focus on different subtopics or to apply a topic to different localities. ayuda urbana, for example, is spawning subdomains related to particular civic practices and engaging members with particular expertise and interest in those areas. the city-based coalitions of safecities focused on the same issues but within the context of their situations. all these subdivisions retain a global coherence that gives the entire system a recognisable identity and allows members to see themselves as belonging to an overall community even as they focus on local issues. fractal community. topical and geographic subgroups help create local intimacy, but they must be connected in ways that strengthen the overall fabric of the network. a key to this process is multimembership. members such as those in the safecities network join at the local level but end up participating in multiple communities in ways that help interweave relationships in the broader community. as a result, they become brokers of relationships between levels in equivalent types of communities. this works because trust relationships have a transitive character: i trust people trusted by those i trust. the police chief in highpoint, for example, had developed strong relationships with fbi officials, which in turn encouraged his peers to work more closely with federal agents. fractal practice. useful knowledge is not of the cookie-cutter variety. local conditions require adaptability and intelligent application. a fractal community is useful in this regard because it allows people to explore the principles that underlie a successful local practice and discuss ideas and methods in ways that make them relevant to circumstances elsewhere. a fractal community can create a shared repertoire and develop global principles while remaining true to local knowledge and idiosyncrasies. moreover, if one locality has a problem or an idea, the broader community provides an extraordinary learning laboratory to test proposals in practice with motivated sites. in the safecities community, local coalition members were ready and willing to share results quickly and convincingly with peers and then translate these into action. a safecities member from michigan reported, for example, that a visit to meet with innovating colleagues in highpoint 'added ideas and motivation to an initiative that we had been planning for a year. once our mayor visited, he wanted to do it.' highpoint members then helped the michigan coalition adapt their model successfully. each locality constitutes a local learning experiment that benefits from and contributes to the overall learning system. the key insight of a fractal structure is that crucial features of communities of practice can be maintained no matter how many participants join -as long as the basic configuration, organising principles, and opportunities for local engagement are the same. at scale, in fact, the learning potential of the overall network and the influence at local levels can increase significantly. the key challenge of a large-scale learning system is not whether people can learn from each other without direct contact but whether they can trust a broader community of communities to serve their local goals as well as a global purpose. this depends on the communities at all levels -local, state, national, and international -to establish a culture of trust, reciprocity, and shared values. developing this social capital across all levels is the critical success factor for going to scale. the evolution of a learning system must therefore be paced at the time-scale of social relationships, not according to an externally imposed objective to achieve short-term results. organisers need be careful not to scale up too fast. they need to establish trust and shared values at different levels of aggregation through various mechanisms, including a network of trusted brokers across localities. in the civic domain, the institutional context can be fragmented and the issues politically charged. this presents particular challenges for finding sponsorship, organising support, and managing potentially conflicting constituencies. sponsorship. all three communities depended on sponsorship from executives such as the mayor of chicago, the vice president of the united states, or representatives of the world bank and funding governments. sponsorship is especially important for large-scale learning systems that will require additional activities to connect localities. it can be difficult, however, to identify the 'client' who benefits when a learning system is so dispersed. when you try to engage a city to sponsor a constellation of cross-sector communities of practice to address an array of civic domains, where do you start? a civic community of practice is such an innovative approach that leaders typically do not have enough context to see its value. sustained sponsorship, furthermore, requires community members to make the value visible enough to demonstrate the payoff of sponsor and stakeholder investments. finally, the legitimacy of sponsorship can be contested in a politically fractious context, where the role of institutions such as the world bank or the federal government in orchestrating local affairs is not universally welcome. support. process support was key to the communities we have described. they needed help with local event planning, finding resources, coordinating projects across levels, finding others to connect with, and designing ways to connect. all three communities needed facilitation at meetings, and safecities and ayuda urbana both required moderation for their online interactions. a challenge for civic learning systems is that there may be no clearly defined institutional context or financing model for process support. the ayuda urbana experience also suggests that one must be ready to provide a lot of support at the start to help develop members' local capabilities and prepare the group to operate more independently. civic communities of practice also need help to build a technology infrastructure for communicating across geographies and time zones, and for building accessible knowledge repositories. this can be particularly difficult when communities span multiple organisational contexts. conflict management and collaborative inquiry. civic communities of practice organised around contentious issues such as housing, education, and health will face considerable obstacles from formal and informal groups with entrenched and opposing views and interests. there are good reasons these basic conflicts have been so intractable: views and values are divergent and trust among players is often low. moreover, businesses, nonprofits, governments, and universities have reasons to resist the development of communities of practice. these formal organisations and their leaders have developed established, privileged positions in society, and changes initiated by community members may not be welcomed. inevitable mistakes early on could further diminish low trust levels and reduce the low-to-medium public readiness to invest time in these unfamiliar social commitments. communities that face such tensions will have to develop expertise in collaborative inquiry and conflict management and learn to build trust over time through activities that enable members to find common ground. there is an emerging, global zeitgeist about community and learning. these issues have become commonplace in multinational organisations -private, public, and nonprofit. still, when one looks at the learning requirements of the world, the complexity of the required learning system may seem so overwhelming as to discourage action. but the advantage of a community-of-practice approach is that it can be evolutionary -starting small and building up progressively, one community at a time. it is not necessary to have broad alignment of the kind required for designing or changing formal structures. we can start wherever there is opportunity, energy, and existing connections. we can build on what already exists. indeed, we have found successful examples of initiatives to cultivate learning systems: within cities, across cities at a national level, and across cities internationally. taken together, these early examples paint a picture of what a mature world learning system may look like, and they give some indication of what it will take to cultivate such a system. we now need to develop frameworks for describing the organisational nature of civil society as a community-based action-learning system -and tools and methods for cultivating such systems. this chapter is thus not only a call to action and a proposal for what is possible. it also calls for a new discipline. a discipline that expands the field of organisation design and applies analogous principles at the world level. a discipline that promotes the development of strategic social learning systems to steward civic practices at local, national, and global levels. a discipline whose scope is the world and whose focus is our ability to design the world as a learning system -a discipline of world design. this chapter is only a beginning. there are many established and emerging disciplines -political science, economic sociology, social network analysis -that can inform the work in this domain. a community-based approach to world design is not a silver bullet for solving the problems of the world. while the emphasis here has been on community, a complete discipline of world design would address how the power of communities can be most fully realised by aligning community activities within a broader ecology of formal and informal structures -institutions, cultural groups, laws, and social networks. to steward such a discipline, we need a community of practice ourselvesor indeed a constellation of communities on the topic of world design, at local, national, and global levels. for instance, a small group of people passionate about civic development may gather to outline an approach to cultivating the city as a learning system. they might connect with various civic leaders and extant initiatives, and organise a gathering for the purpose of assessing the implicit structure of the city today as a practice-based learning system. which practices have active stewardship? what groups are providing it with what sorts of initiatives and results? who is represented? where is the focus of sponsors -such as local government, corporations, universities, the media, and foundations? to what degree is there a shared language and understanding across constituencies of the nature of crosssector civic governance and how to participate effectively? these questions become the concerns of 'meta-communities' at various levels, which can link together -as a community of meta-communities -and build their own practice to support the development, effectiveness, and influence of civic communities at all levels. the complexity and intelligence of such a social learning system must match the complexity of world-design challenges and the knowledge requirements associated with them. the messy problems of civil society require a commensurate capacity for learning, innovation, and collaboration across diverse constituencies and levels. the challenge to intentionally and systematically design and develop the world as a learning system must be a global, diverse, interwoven social movement. this social movement is not simply about advocacy; nor is it a political revolution. rather, it is about the transformation of civic consciousness -a way of thinking about governance as an action-learning process, as a role for civic actors across sectors, as a process that links the local and global in clear and concrete ways. and it depends, fundamentally, on individuals finding a way to participate locally -whether that means a community of place or practice, or both -a way that gives them access to the entire learning system. let us begin. the division of labor in society chaos: making a new science organizing for economic development in chicago: a case study of strategy communities of practice: a new tool for managers,' ibm endowment for the business of government our world as a learning system: a communities-of-practice approach ayuda urbana: a constellation of communities of practice focused on urban issues and challenges in central america, mexico, and the caribbean region. written for the beep project of the european union cultivating communities of practice leadership and the new science key: cord-028660-hi35xvni authors: chen, jie; li, yang; zhao, shu; wang, xiangyang; zhang, yanping title: three-way decisions community detection model based on weighted graph representation date: 2020-06-10 journal: rough sets doi: 10.1007/978-3-030-52705-1_11 sha: doc_id: 28660 cord_uid: hi35xvni community detection is of great significance to the study of complex networks. community detection algorithm based on three-way decisions (twd) forms a multi-layered community structure by hierarchical clustering and then selects a suitable layer as the community detection result. however, this layer usually contains overlapping communities. based on the idea of twd, we define the overlapping part in the communities as boundary region (bnd), and the non-overlapping part as positive region (pos) or negative region (neg). how to correctly divide the nodes in the bnd into the pos or neg is a challenge for three-way decisions community detection. the general methods to deal with boundary region are modularity increment and similarity calculation. but these methods only take advantage of the local features of the network, without considering the information of the divided communities and the similarity of the global structure. therefore, in this paper, we propose a method for three-way decisions community detection based on weighted graph representation (wgr-twd). the weighted graph representation (wgr) can well transform the global structure into vector representation and make the two nodes in the boundary region more similar by using frequency of appearing in the same community as the weight. firstly, the multi-layered community structure is constructed by hierarchical clustering. the target layer is selected according to the extended modularity value of each layer. secondly, all nodes are converted into vectors by wgr. finally, the nodes in the bnd are divided into the pos or neg based on cosine similarity. experiments on real-world networks demonstrate that wgr-twd is effective for community detection in networks compared with the state-of-the-art algorithms. nowadays, there are all kinds of complex systems with specific functions in the real world such as online social systems, medical systems and computer systems. these systems can be abstracted into networks with complex internal structures, called complex networks. the research of complex networks has received more and more attention due to the development of the internet. community structure [6, 23] is a common feature of complex networks, which means that a network consists of several communities, the connections between communities are sparse and the connections within a community are dense [10] . mining the community structure in the network is of great significance to understand the network structure, analyze the network characteristics and predict the network behavior. thus, community detection has become one of the most important issues in the study of complex networks. in recent years, a great deal of research is devoted to community detection in networks. most community detection methods are used to identify nonoverlapping communities (i.e., a node belongs to only one community). the main approaches include graph partitioning and clustering [9, 10, 13] , modularity maximization [1, 20] , information theory [12, 25] and non-negative matrix factorization [16, 27] . the kernighan-lin algorithm [13] is a heuristic graph partitioning method that detects communities by optimizing the edges within and between communities. gn algorithm [10] is a representative hierarchical clustering method, which can find communities by removing the links between communities. blondel et al. proposed the louvain algorithm [1] , which is a well-known optimization method based on modularity. it is used to handle large-scale networks due to low time complexity. liu et al. [16] put forward a community detection method by using non-negative matrix factorization. zhao et al. [33] introduced the idea of granular computing into the community detection of network and proposed a community detection method based on clustering granulation. the existing non-overlapping community detection algorithms have made great achievements, but these algorithms only use the traditional two-way decisions [29, 30] method (the acceptance or rejection decision) to deal with the overlapping nodes between communities. compared with the two-way decisions method, the three-way decisions theory (twd) [28] adds a non-commitment decision. the main idea of twd is to divide an entity set into three disjoint regions, which are denoted as positive region (pos), negative region (neg) and boundary region (bnd) respectively. the pos adopts the acceptance decision, the neg adopts the rejection decision, and the bnd adopts the noncommitment decision (i.e., entities that cannot make a decision based on the current information are placed in the bnd). for entities in the bnd, we can further mine more information to realize their final partition. the introduction of non-commitment decision can effectively solve the decision-making errors caused by insufficient information, which is more flexible and closer to the actual situation. how to deal with the boundary region has become a key issue for threeway decisions community detection. at present, the commonly used methods to process the boundary region include modularity increment [20] and similarity calculation [2, 8] . but these methods only take advantage of the local features of the network, without considering the information of the divided communities and the similarity of the global structure. therefore, how to tackle the boundary region effectively is a challenge. in this paper, we propose a three-way decisions community detection model based on weighted graph representation (wgr-twd). the graph representation can well transform the global structure of the network into vector representation and make the two nodes in the boundary region that appear in the same community more similar by using the weight. firstly, the multi-layered community structure is constructed by hierarchical clustering. the target layer is selected according to the extended modularity value of each layer. secondly, all nodes are converted into vectors by weighted graph representation. finally, nodes in the boundary region are divided into positive or negative region based on cosine similarity. thus, non-overlapping community detection is realized. the key contributions of this paper can be summarized as follows: (1) we use weighted graph representation to obtain the global structure information of the network to guide the processing of the boundary region, which gets a better three-way decisions community detection method. (2) based on the knowledge of the communities in the target layer, we make the two nodes connected by a direct edge in the boundary region more similar by using frequency of appearing in the same community as the weight. then the walk sequences are constructed according to the weight of the edge. finally, the skip-gram model is used to obtain the vector representation of nodes. therefore, the weighted graph representation method is realized. the rest of this paper is organized as follows. we introduce related work in sect. 2. we give the detailed description of our algorithm in sect. 3. experiments on real-world networks are reported in sect. 4. finally, we conclude the paper in sect. 5. hierarchical clustering method has been widely used in community detection due to the hierarchical nature of the network structure. this approach can be divided into two forms: divisive method and agglomerative method. the divisive method removes the link with the lowest similarity index repeatedly, while the agglomerative method merges the pair of clusters with the highest similarity index repeatedly. these two methods eventually form a dendrogram, and communities are detected by cutting the tree. the research of community detection based on hierarchical clustering has received widespread attention from scholars. girvan and newman proposed the gn algorithm [10] , which is a typical divisive method. clauset et al. [5] proposed a community detection algorithm based on data analysis, which is a representative agglomerative method. fortunato et al. [9] presented an algorithm to find community structures based on node information centrality. chen et al. proposed the lcv algorithm [4] which detects communities by finding local central nodes. zhang et al. [32] introduced a hierarchical community detection algorithm based on partial matrix convergence using random walks. combining hierarchical clustering with granular computing, we introduce an agglomerative method based on variable granularity to build a dendrogram. given an undirected and unweighted graph g = (v, e), where v is the set of nodes, e denotes the set of edges. the set of neighbor nodes to a node v i is denoted as the formation process of the initial granules is as follows. first, we calculate the local importance of each node in the network. the local importance of a node v i is defined as follows: where is the degree of node v i , and |·| denotes the number of elements in a set. second, all important nodes are found according to the local importance of nodes. the node v i is an important node if i (v i ) > 0. finally, for any important node, an initial granule is composed of all neighbor nodes of the important node and the important node itself. after all the initial granules are obtained, the hierarchical clustering method based on variable granularity is described. the clustering coefficient between the two granules is defined as where med {} is a median function. the clustering process is as follows. firstly, for ∀c m i , c m j ∈ h m , the clustering coefficient between them is calculated. then the clustering threshold λ m of the current layer is calculated. and the maximum clustering coefficient is found, which is denoted as f c m α , c m β . if f c m α , c m β λ m , the two granules c m α and c m β are merged to form a new granule and the new granule is added to h m+1 . otherwise, all the granules in h m are added to h m+1 and h m is set to empty. for each layer, repeat above clustering process until all nodes in the network are in a granule. therefore, a dendrogram is built. traditional network representation usually uses high-dimensional sparse vectors, which takes more running time and computational space in statistical learning. network representation learning (nrl) is proposed to address the problem. nrl aims to learn the low-dimensional potential representations of nodes in networks. the learned representations can be used as features of the graph for various graph-based tasks, such as classification, clustering, link prediction, community detection, and visualization. deepwalk [24] is the first influential nrl model in recent years, which adopts the approach of natural language processing by using the skip-gram model [18, 19] to learn the representation of nodes in the network. the goal of skip-gram is to maximize the probability of co-occurrence among the words that appear within a window. deepwalk first generates a large number of random walk sequences by sampling from the network. these walk sequences can be analogized to the sentences of the article, and the nodes are analogized to the words in the sentence. then skip-gram can be applied to these walk sequences to acquire network embedding. deepwalk can express the connection of the network well, and has high efficiency when the network is large. to effectively deal with overlapping communities in the target layer, a weighted graph representation approach is proposed. at first, a weighted graph is constructed according to the community structure of the target layer. the weights of edges in an unweighted graph are defined as follows where σ ij is the number of communities in which nodes v i and v j appear in a community at the same time, n c is the total number of communities in the target layer. after that, an improved deepwalk (idw) model is used to acquire the vector representation of all nodes in the graph. unlike deepwalk, the idw model constructs the walk sequences according to the weight of the edge. the greater the weight, the higher the walk probability. assume that the current walk node is v i , if v j ∈ n (v i ), then the walk probability from node v i to node v j is after obtaining all the walk sequences, the skip-gram model is used to learn the vector representation of nodes from the walk sequences. the objective function of idm is as follows where r (v i ) is the vector representation of node v i , ω is the window size which is maximum distance between the current and predicted node within a walk sequence. thus, the vector representation of all nodes in the network is obtained. we will present the proposed wgr-twd algorithm in this section. figure 1 shows the overall framework of the proposed algorithm. our algorithm consists of two parts: the construction of multi-layered community structure and boundary region processing. the first part, we employ the hierarchical clustering method based on variable granularity to construct a multi-layered community structure according to sect. 2.1. some overlapping communities exist in the multi-layered community structure because of clustering mechanism, so we use the extended modularity (eq) [26] to measure the partition quality of each layer. it is defined as follows where m is the number of edges in the network, c i represents a community, o u is the number of communities that node u belongs to, a uv is the element of adjacent matrix, and d u is the degree of node u. a larger eq value means better performance for overlapping community division. thus, we select the layer corresponding to the largest eq value as the target layer. the second part introduces the method of dealing with overlapping communities in the target layer. since there are overlapping communities in the target layer, we need to further divide the target layer to achieve non-overlapping community detection. therefore, the three-way decisions theory (twd) is introduced to handle overlapping communities. based on the idea of twd, we define the overlapping part in the communities as boundary region (bnd), and the non-overlapping part as positive region (pos) or negative region (neg). and our goal is to process nodes in the bnd. first of all, we adopt the weighted graph representation method to learn the vector representation of all nodes in the network. after that, the nodes in the bnd are divided into the pos or neg by using cosine similarity. suppose the vector of node u is u = (x 1 , x 2 , ..., x n ) , node v is v = (y 1 , y 2 , ..., y n ) , then the cosine similarity is defined as for arbitrary node v i in the bnd, find out all communities containing node v i in the target layer, calculate the average value of cosine similarity between node v i and non-overlapping nodes in each community as the similarity between node v i and this community, then join node v i into the community corresponding to the maximum similarity and update the community structure of the target layer. repeat the above operation until all nodes in the bnd are processed. the wgr-twd algorithm is described in algorithm 1. we test the performance of our method on eight real-world datasets in which each dataset is described as follows, and the main information of those datasets are shown in table 1 . zachary's karate club [31] . this is a social network of friendships between 34 members of a karate club at a us university in the 1970s. dolphin social network [17] . it is an undirected social network of frequent associations between 62 dolphins in a community living off doubtful sound, new zealand. books about us politics [22] . a network of books about us politics published around the time of the 2004 presidential election and sold by the online bookseller amazon.com. edges between books represent frequent co-purchasing of books by the same buyers. american college football [10] . a network of american football games between division ia colleges in 2000. email communication network [21] . it is a complex network which indicates the email communications of a university. the network was composed by alexandre arenas. facebook [15] . the network was collected from survey participants using facebook app. geom [11] . the authors collaboration network in computational geometry. collaboration [14] . the network is from the e-print arxiv and covers scientific collaborations between authors papers submitted to high energy physics theory category. in this paper, two representative algorithms are chosen to compare with the proposed wgr-twd, as shown below: -modularity increment (mi) [3] . a hierarchical clustering method based on variable granularity, and the overlapping nodes between communities are divided according to modularity optimization. -deepwalk [24] . it is a network representation learning method. this approach is used to handle the overlapping communities in the target layer. we employ two widely used criteria to evaluate the performance of community detection algorithms. the first index is modularity (q) [5] , which is often used when the real community structure is not known. q is defined as follows where m is the number of edges in the network, a is the adjacent matrix, d i is the degree of node i, c i represents the community to which node i belongs, and δ (c i , c j ) = 1 when c i = c j , else δ (c i , c j ) = 0. the higher the modularity value, the better the result of community detection. another index is normalized mutual information (nmi) [7] , which is defined as follows where c a (c b ) denotes the number of communities in partition a (b), c ij is the number of nodes shared by community i in partition a and by community j in partition b, c i. (c .j ) represents the sum of elements of matrix c in row i (column j), and n is the number of nodes in the network. a higher value of nmi indicates the detected community structure is closer to the real community structure. in the networks with known real partition (the first four small networks), we use two indicators (q and nmi) to evaluate our algorithm. table 2 presents the community detection results of the proposed algorithm and the baseline algorithms on networks with known real partition. we can see that our method to further verify the effectiveness of the proposed algorithm, the mi method is used to deal with each layer in the multi-layered community structure. and we select the layer corresponding to the maximum q value as the target layer. the experimental results are shown in table 3 . compared with table 2, table 3 can obtain higher q value. combined with tables 2 and 3, our method can get better community detection results compared with the baseline methods. we also conducted experiments on four large networks. on these networks, the real partition is unknown. therefore, we only use modularity to evaluate the performance of different methods. table 4 shows the community detection results of the proposed method and baseline methods. on the first three networks, we can see that our method obtains better results compared with the two baseline methods. on the collaboration dataset, the mi method achieves the best performance which is a little bit higher than our method. the main reason is that the collaboration network is very sparse which leads to poor vector representation of the nodes. in conclusion, the proposed method effectively addresses the problem of non-overlapping community detection in networks. in this paper, we propose a method for three-way decisions community detection based on weighted graph representation. the target layer in multi-layered community structure is selected according to the extended modularity value of each layer. for the overlapping communities in the target layer, the weighted graph representation can well transform the global structure into vector representation and make the two nodes in the boundary region more similar by using frequency of appearing in the same community as the weight. finally, the nodes in the boundary region are divided according to cosine similarity. experiments on real-world networks demonstrate that the proposed method is effective for community detection in networks. fast unfolding of communities in large networks three-way dicision community detection algorithm based on local group information vghc: a variable granularity hierarchical clustering for community detection a method for local community detection by finding maximaldegree nodes finding community structure in very large networks detecting community structure via the maximal sub-graphs and belonging degrees in complex networks comparing community structure identification three-way decision based on non-overlapping community division method to find community structures based on information centrality community structure in social and biological networks complex network clustering by multiobjective discrete particle swarm optimization based on decomposition information limits for recovering a hidden community an efficient heuristic procedure for partitioning graphs graph evolution: densification and shrinking diameters learning to discover social circles in ego networks semi-supervised community detection based on non-negative matrix factorization with node popularity the emergent properties of a dolphin social network efficient estimation of word representations in vector space distributed representations of words and phrases and their compositionality fast algorithm for detecting community structure in networks finding community structure in networks using the eigenvectors of matrices modularity and community structure in networks finding and evaluating community structure in networks deepwalk: online learning of social representations an information-theoretic framework for resolving community structure in complex networks detect overlapping and hierarchical community structure in networks nonnegative matrix factorization with mixed hypergraph regularization for community detection three-way decision: an interpretation of rules in rough set theory three-way decisions with probabilistic rough sets two semantic issues in a probabilistic rough set model an information flow model for conflict and fission in small groups hierarchical community detection based on partial matrix convergence using random walks community detection algorithm based on clustering granulation acknowledgments. this work is supported by the national natural science foundation of china (grants numbers 61876001) and the major program of the national social science foundation of china (grant no. 18zda032). key: cord-023989-d6c1is5s authors: williams, richard allen title: conclusion and afterword date: 2020-04-25 journal: blacks in medicine doi: 10.1007/978-3-030-41960-8_10 sha: doc_id: 23989 cord_uid: d6c1is5s the previous chapters contain a great deal of medical, socioeconomic, demographic, epidemiologic, racial, ethnic, educational, and cultural information pertaining particularly to the black population of the united states, but it is admittedly somewhat incomplete. there is so much more that might have been included, but space and time limitations preclude a more comprehensive coverage of everything that touches upon the healthcare scene involving black americans. in this brief postscript, i would like to suggest to the reader to consider a few more important issues affecting black health. the book that you have just read contains a great deal of medical, socioeconomic, demographic, epidemiologic, racial, ethnic, educational, and cultural information pertaining particularly to the black population of the united states, but it is admittedly somewhat incomplete. there is so much more that might have been included, but space and time limitations preclude a more comprehensive coverage of everything that touches upon the healthcare scene involving black americans. in this brief postscript, i would like to suggest to the reader to consider a few more important issues affecting black health. the problem of insufficient recruitment of african american students into careers in medicine is often referred to as the medical school "pipeline" problem, which has been highlighted by several incisive publications such as an american crisis: the growing absence of black men in medicine and science, a book whose lead author was cato t. laurencin, md, phd, rapporteur for the national academies of sciences, engineering, and medicine [1] . in the proceedings of a joint workshop in which several prominent luminaries participated, it was pointed out that blacks, and black men in particular, are underrepresented among medical school applicants ( fig. 10 .1) [2] . as louis sullivan, md, chairman and ceo of the sullivan alliance to transform the health professions, noted in his keynote speech, although african americans constitute 13% of the us population, they constitute only 7% of medical students and less than 3% of practicing doctors. in addition, we seem to be reversing course regarding the admission of black men to medical school; in 1978, 542 black males matriculated in medical schools compared to 515 blacks in 2014 ( fig. 10 .2) [2] . thus, the pipeline has grown narrower, with insufficient numbers of black doctors eventually being produced. this has ramifications for the black community, since it has been shown that black patients elect to receive more preventive care when the providers are black as compared to when they are not [3] . in addition, physicians who are members of underrepresented groups are more likely than whites to serve poor, minority, and medicaid populations [4] . there is also a need for more diversity in leadership positions in academic medicine. as stated by cantor et al., "diversity improves patient care….promoting women and underrepresented minorities to leadership positions may well enable academic medicine to better serve our diverse population" [5] . only 2% of full-time medical school faculty consists of black men, according to the association of american medical colleges (aamc). violence in the black community is a problem that has flown under the radar until recently, when the national medical association (nma) created a task force to address it. the nma's working group on gun violence and police use of force, of which i was a member, was led by national co-chairs roger a. mitchell, jr., md, chief medical examiner for the district of columbia, and [2] ; graphic courtesy of the national academy of medicine https://nam. edu/an-american-crisis-the-lack-of-black-men-in-medicine/) eva louise frazer, md, an internist and prominent community activist from st. louis, missouri [6] . following an initial white paper on the subject, a fullscale article was published and disseminated in 2018 [7] . the report detailed the police use of excessive force, and many approaches to reducing the level of violence were suggested, including greater involvement by the community of black physicians who must play a vital role in eradicating this epidemic. more interaction between the police, physicians, and the public was recommended. the nma has begun discussions with the national organization of black law enforcement executives (noble; https://noblenational.org/) on the issue of violence and the police use of force in the black community. this dialogue has been facilitated by former norfolk, virginia, chief of police and former noble president john i. dixon iii and sheila l. thorne, president and ceo of the multicultural healthcare marketing group, who have collaborated with the nma and other medical groups in communities of color to develop strategies to combat this problem, which is spreading explosively throughout the country. recently, there has been speculation that exposure to violence has had psychopathological fallout in the black community with the development of post-traumatic stress disorder (ptsd), which is defined as a trauma-or stress-related reaction that may develop in individuals following exposure to an ordeal or an event in which death or physical harm has occurred, is witnessed, or is threatened. this is another example of the public health consequences of violence and police brutality in the black community, leading to a population that may be in need of psychotherapy. it is often said that being black in america exposes one of necessity to mental illness on a personal, familial, or community level. mental health issues in the black community have been largely ignored or swept under the carpet. we must bring greater recognition to this problem in order to treat it. according to the us department of health and human services, african americans are 20% more likely than whites to report that they have severe psychological stress [8] . however, many blacks do not present themselves for psychiatric attention because they have a fear of being stigmatized; studies have shown that african americans view mental illness as highly stigmatizing, resulting in low treatment-seeking [9] . in addition, they fear the criminalization of mental illness, according to patrisse cullors of black lives matter [10] . tied to this is the sudden increase in suicide attempts by young black males, which has been chronicled in a special story by cnn [11] , based on a cdc study that was recently released, containing data from 1991 to 2017. this is a prime area for more research and prevention of a serious health problem in the black community. hopefully, organizations like the trevor project, which provides crisis intervention and suicide prevention services primarily to lgbtq/q young people, will become more involved in the special situation facing black youth, who are more impacted by poverty, low income, joblessness, racism, and homelessness. high maternal mortality is a problem that the black community has silently dealt with for decades. it has several definitions. one definition is death of a woman while pregnant or within 42 days of end of pregnancy, irrespective of the cause of death. defined as the number of maternal or pregnancy-related deaths in a given time period per 100,000 live births during the same period, the maternal mortality rate has been rising for american women in general but much more so for black women, who experience more than three times the rate that white women do. in fact, as fig. 10.3 shows, the statistics for black women in the united states are closer to women from brazil, uzbekistan, malaysia, and mexico compared to non-hispanic american white women whose statistical profile resembles that of women in more affluent countries such as japan, new zealand, the united kingdom, and france [12] . there is also a difference in causation of pregnancy-related deaths between blacks and whites, as reported by a study of maternal mortality review committee data by the building us capacity to review and prevent maternal deaths initiative, a partnership of the association of maternal and child health programs (amchp), the centers for disease control and prevention (cdc) division of reproductive health, and cdc foundation (fig. 10.4 ) [13] . the main causes in blacks are cardiomyopathy, preeclampsia, and eclampsia, whereas the principal causes in whites are cardiovascular and coronary conditions, hemorrhage, mental health conditions, and infections. members of the congressional black caucus, and senator kamala harris in particular, have expressed grave concern about these disparities in maternal mortality. senator harris says that racial bias is part of the cause. senator elizabeth warren agrees. one area of focus is on prevention; it is estimated that about twothirds of black maternal deaths are entirely preventable if more attention is paid to socioeconomic determinants of health by eliminating social inequities through the provision of clean drinking water, better housing, improved transportation, and greater access to high-standard healthcare facilities for pre-and postnatal care. however, it should also be recognized that higher mortality in black women transcends social class to some extent in that those who are more affluent and better educated are also exposed to the risk, such as in the case of black tennis star serena williams, who almost died from a complication of pregnancy. obviously, more research is needed in this area. the march of dimes is one agency that is focusing on this problem, and congresswomen alma adams (d-nc) and lauren underwood (d-il) have launched the black maternal health caucus to improve outcomes in this problem area. it seeks to raise awareness of the condition in the us congress so that black maternal health becomes established as a national priority. they are interested in hearing from constituents from throughout the country. they may be reached at their office at 2436 rayburn house office building, washington, dc, 20515-3312 or by calling their office at 202-225-1510. we have much work to do to make an impact on the factors causing disparities in healthcare delivery and to protect the lives of all citizens of the united states, and especially of those who are the most vulnerable, such as the black population and other people of color. it is my hope that one day it will be unnecessary to make efforts like this on behalf of discrete segments of our society, because we will all truly be equal. the poem common dust by black poet georgia douglas johnson expresses that hope: and who shall separate the dust. what later we shall be: whose keen discerning eye will scan. and solve the mystery? the high, the low, the rich, the poor, the black, the white, the red, and all the chromatique between, of whom shall it be said: here trusty, rachel turner, jasira ziglar). "we are our ancestors' wildest dreams," student russell j. ledet wrote in a tweet sharing a photograph of the moment (fig. 10.5) . thus, our saga of blacks in medicine has come full circle, from the shackles of slavery to the halls of sophisticated medical schools, and back, to revisit the place where so much suffering occurred. we can thank those students for providing the connection between the brutal past and the bright future that awaits them. also, as this book was about to go to press, the coronavirus (covid-19) pandemic erupted and is still largely uncontrolled at the time of this writing. although it is not possible to review all aspects of this crisis in this small space, it is important to mention some relevant issues regarding the disproportionate impact that this disease is having on communities of color in the united states. early data indicates that the occurrence rate and the death rate are disproportionately high in large cities even where african americans are not the majority of the population. for instance, according to cnn host and journalist van jones, who spoke on cnn on april 6, 2020 in an opinion piece titled "black america must wake up to this viral threat", in milwaukee county, wisconsin, where 27 percent of the residents are black, almost half of those infected with the virus are black, and 81 percent of those who died of covid-19 are african american. in illinois, where blacks make up only 14.6 percent of the population, 28 percent of those affected are black. in michigan, including detroit, blacks account for 33 percent of the cases and 40 percent of the deaths. and in louisiana, where blacks are not in the majority, governor john bel edwards has indicated that almost 70 percent of the deaths are in black people. why is this happening? one might speculate that the co-morbidities that predominate in black communities such as high rates of heart disease, hypertension, diabetes, asthma, cancer, and other disorders, combined with a high incidence of the socioeconomic determinants of health make the black population particularly vulnerable to covid-19 infection. all of the data have not been gathered because very few cities and states are tracking the incidence and deaths by race and ethnicity, which is necessary to draw a clear picture of what is going on. without that data, resources and funding such as money from the recently passed $2 trillion dollar stimulus bill may not be appropriately distributed to those in poor communities of color where the need for relief seems to be the greatest. and more information and data should be demanded from the centers for disease control and prevention (cdc) which so far has been reluctant to release anything to the public, despite requests made by some congressmen including senator wyden of oregon. we can and must do more to avert unnecessary deaths and suffering from this deadly scourge. blacks, including african american organizations, must come to the rescue of themselves before it is too late. an american crisis: the growing absence of black men in medicine and science an american crisis: the lack of black men in medicine does diversity matter for health? experimental evidence from oakland physician service to the underserved: implications for affirmative action in medical education unplugging the pipeline -a call for term limits in academic medicine national medical association seeks to address violence in the african american community. philadelphia tribune the violence epidemic in the african american community: a call by the national medical association for comprehensive reform issues/black-african-american-communities-and-mental-health. accessed african american men and women's attitude toward mental illness, perceptions of stigma, and preferred coping behaviors black lives matter's patrice cullors on the criminalization of mental illness suicide attempts by black teens are increasing, study says america is failing its black mothers. harvard public health report from nine maternal mortality review committees key: cord-284314-jpxaf02p authors: geekiyanage, devindi; fernando, terrence; keraminiyage, kaushal title: assessing the state of the art in community engagement for participatory decision-making in disaster risk-sensitive urban development date: 2020-09-16 journal: int j disaster risk reduct doi: 10.1016/j.ijdrr.2020.101847 sha: doc_id: 284314 cord_uid: jpxaf02p vulnerable communities are often marginalized in the decision-making process in urban development due to barriers to community entry and challenges for community engagement. the state-of-the-art on these constraints’ limits to a specific region, state, or a context; thus, the knowledge is scattered and not forming a global perspective on how and why communities’ engagement in urban development has been hindered. having a sound understanding of the existing barriers and challenges to community inclusive decision-making process is paramount for finding solutions for transforming current practices towards equitable urban development. accordingly, this comprehensive, structured literature review aims to consolidate literature of the current challenges and barriers to community-driven decision-making in urban development and of the potential solutions to overcome them. a structured literature review covering indexed publications from 2010 to 2020 was carried out to identify and classify barriers/challenges and solutions that exist at present. following a systematic filtering process, a total of 63 out of 1324 research contributions have been considered for an in-depth analysis. the study found 48 barriers and challenges regarding the current context, available infrastructure for community engagement, and current decision-making processes. of all, the lack of communities’ knowledge and awareness, absence of meaningful community engagement, and ill-defined aims and purpose of community engagement were identified as the topmost constraints. by synthesising the current research, the study found that these barriers can potentially be overcome through attitude transformation and capacity building of both community and professionals, investment in community engagement, and changes to present stakeholder engagement processes and policies. the idea of inclusive development involving communities rides high on the international agenda, following the publications of the united nation's sustainable development goals in september 2015, the sendai framework for disaster risk reduction 2015-2030, and the habitat iii new urban agenda in 2016. as mentioned in [1] , community engagement can be considered as a "purposeful process which develops a working relationship between communities, community organisations and public and private bodies to help them to identify and act on community needs and ambitions". even though many vulnerable communities are facing the full force of many catastrophic events, only a few attempts have been made in involving vulnerable communities [2] to utilise their experience in developing risk mitigation plans and risk responsive developments. for instance, local communities are largely involved in adaptation rather than in mitigation with few training sessions on increasing the community's awareness of, and preparedness for, disasters [3] . most of the current decisionmaking processes are top-down and employ a top-down process which alienates local community members [4] . the local communities are considered as beneficiaries and not as participants in risk-sensitive urban development activities. as a result, government policies are being implemented giving little consideration to local knowledge of vulnerable communities [3, 5] . consequently, community knowledge and their concerns of disaster risks in the locality are being ignored in urban planning and development projects [3, 6, 7] , hence failing to capture locally significant factors. this state poses a challenge for achieving equitable and sustainable developments that address the concerns of vulnerable communities since only the governmental strategies which are typically concerned with economic growth are given priority. in this regard, countries should introduce and enforce processes that allow citizens, including vulnerable groups, to participate in development planning and policymaking [8, 9] . even though the research based on group model building [10] [11] [12] [13] and community based system dynamics [14] [15] [16] [17] have shown the potential to engage communities in development agendas, it is evident that the practical inclusion of vulnerable communities in decisionmaking is still insignificant. therefore, involving vulnerable communities and employing a multi-level stakeholder collaborative process to build consensus have become pressing challenges in current drr and urban planning & development projects [18] . despite the recent focus on urban drr and increasing investments for urban development projects and smart cities, only a handful of studies have focused on community inclusive developments. even though many researchers have investigated barriers and practical challenges to participatory decision-making, these studies are predominantly focused on region-specific or context-specific challenges without a global perspective and no prioritisation of these constraints. therefore, a comprehensive understanding of existing barriers to community entry and issues and challenges in productive community engagement in urban planning and development still warrants a proper investigation. this structured literature review, therefore, aims to fill this gap by consolidating the state-of-the-art of barriers and challenges in participatory decision-making, which can be taken as the basis for future research to address these findings through community inclusive urban development projects. the current study aims to identify an index of barriers and challenges and the potential solutions for overcoming them through a structured literature survey. it is hoped that this study will provide a sound foundation for further research and development in the field of community-driven participatory approaches for promoting equitable urban development solutions. initially, the research question of "what are the prevailing barriers and challenges limiting vulnerable communities' involvement in the planning and development process of urban projects?" for this study was developed using the pico (population, intervention, comparison, and outcomes) approach [19] . although it was first applied in clinical trials, the pico approach provides a sound basis for formulating the research question and defining the keywords for the literature survey from the terms included in the research question. following the pico approach, the first step was to construct a logic grid (table 1) and conduct an initial search using the key terms in the grid. alternative terms or synonyms for j o u r n a l p r e -p r o o f the identified concepts were then identified by scanning the titles and abstracts of retrieved articles in this initial search to populate a comprehensive logic grid (table 2) . placing the terms into a logic grid illustrates how the related concepts or synonyms have been combined to construct the final search string [20] . this grid provides a comprehensive search strategy consisting of both keywords/free-text words and index terms [20] . accordingly, the index terms related to the pico terms of the study were searched from the list of keywords offered by the initial literature search. see the keywords with '[it]' in table 2 for the index terms identified. as the final step in developing key terms for the search, search-field descriptors and wildcard characters were applied to the identified keywords and index terms in the logic grid (wildcards are indicated by the '*' sign in table 2 ). once all the search terms were collected and finalized, the final search strategy was developed. initially, the key terms and synonyms in the logic grid were combined using boolean operators: 'or' to combine words/phrases within a column; 'and' to combine words/phrases in different columns. subsequently, the second search was undertaken across all the selected citation databases with the use of the developed search strategy depicted in figure 1 . once the final search was conducted, the search strategy was further refined by selecting relevant filters under search fields, publication year, subject/research area, document type, and language (see table 3 ). the next step of the structured literature review involved the selection of databases. since the use of high-ranking and indexed scholarly journals and conference proceedings are recommended [21] , the search was conducted within two highly recognised citation databases: scopus and web of science. these databases allowed a literature search within a broad range of international scientific journals such as cities, community development, and sustainability, as well as in high-ranking conference proceedings. furthermore, a google search was also conducted to identify non-journal sources such as periodic reports issued by subject-related organisations. finally, all the records generated from the above-mentioned databases were imported to the endnote software for screening and systematic analysis. (barriers or challenges or socioeconomic factors) and ("community involvement" or "human involvement" or "local participation" or "community development" or "urban population" or "citizen science" or "civil society" or "community participation" or "community-based participatory research" or "community-based" or "focus group*" or "participatory research" or "community engagement" or "community-driven" or "community driven" or "community based participatory research " or "community based") and (planning or development or "decision making" or "governance approach" or "adaptive management" or "infrastructure planning" or "planning process" or "polic*" or "procedure*" or "decision-making") and ("urban projects" or "urban area*" or "sustainable development*" or "urban development*" or "land use planning" or cit* or "residential development*" or "smart cit*" or urbanisation) j o u r n a l p r e -p r o o f the complete search found 1,324 records: 1,307 journal articles and conference proceedings from the scopus and web of science citation databases and 17 records from the google search. from these records, 13 duplicate records were removed, and 575 records were selected after a full-text search. preliminary screening of these full-text articles, using the titles, keywords and abstracts found 250 of them to have no relevance to participatory approach and urban development. following the preliminary screening, a final screening was conducted in order to include only the articles that meet the following criteria: (1) deals with challenges, barriers, issues, and best practices for community participation; (2) explicitly focuses on the importance of inclusive developments and community empowerment methods/tools/approaches to overcome existing barriers and challenges to community participation in risk-sensitive urban developments. during this screening process, contributions that discussed participatory approaches in other research areas such as food security and agriculture, health and medical topics, transportation, and waste management were excluded. furthermore, the articles that were related to participatory approaches but did not offer a meaningful discussion on challenges, barriers, issues and/or solutions to overcome them were also excluded. this screening process resulted in 63 research contributions for further in-depth analysis. the depth of the literature search is presented in figure 2 below, according to the preferred reporting of items for systematic reviews and meta-analyses (prisma) method proposed in [22] . as the next step of the structured literature review, the search results were analysed and synthesized to extract the state-of-the-art knowledge on (1) barriers and challenges to community entry and engagement in risk-sensitive urban planning and development, and (2) solutions and best practices to overcome constraints for inclusive urban planning and development. the outcome of this analysis is presented in the following section. the structured literature survey conducted revealed 48 barriers and challenges that constrain community entry and engagement in participatory decision-making in risk-sensitive urban planning or inclusive developments. observing the nature and similarities of the barriers and challenges identified through the structured literature review, these constraints were classified into seven themes under three specific areas: (1) context, (2) infrastructure, and (3) process. the barriers/challenges found were analysed based on the number of citations and ranked according to the percentage of citations derived for each barrier/challenge. table 4 below presents the barriers and challenges identified, together with the results of the analysis. as observed from table 4 , 25 out of the 48 barriers (which is the highest number of barriers per area) were identified as context-specific barriers. these constraints were further classified into three main themes: community capacity (8 barriers), quality of existing relationships (10) , and organisational culture, attitudes, and knowledge (7). among the eight barriers associated with the community capacity, the lack of communities' knowledge and awareness of urban development plans, opportunities, and formal development procedures [5, [23] [24] [25] [26] [27] [28] [29] [30] [31] [32] [33] [34] is prominent (and is the most cited barrier), causing communities to be disengaged from participation. in this regard, protik and nichols-barrer [30] stated that most urban people have no idea about the discernible impacts of community engagement in urban development plans. consultation fatigue, due to a lack of communities' interest in engagement [35] [36] [37] [38] [39] [40] [41] , is the second top barrier with communities and causes the public to not to take part in decisionmaking in sustainable development plans. three further challenges: a lack of capacity within community organisations [23, 33, 34, 42, 43] ; the high levels of poverty that exist for many community members [41, [44] [45] [46] [47] , and low levels of literacy and numeracy and the dominance of oral culture among communities [24, 26, 27, 29, 47] were identified as the next set of barriers hampering community engagement. other barriers to participatory approaches in urban development (due to incapacities and incapability exist within communities) are cultural norms and life circumstances [6, 27, 29, 42] , negative community perceptions of participation in the planning system [24, 28, 43] , and people reluctant to engage due to an inability to attend meetings/training caused by physical impairment and/or a lack of consciousness caused by mental impairment [42] . the lessons learnt and negative experiences from previous and ongoing inclusive development projects such as ch4llenge [36] point out 10 key issues with current relationships among communities, urban planners, and government. the absence or lack of meaningful engagement with communities in the context of urban development (especially with communities that have been marginalised and excluded) [23, 33-35, 38-40, 44, 46, 47, 49, 50] is the most highlighted challenge in this theme as well as the second top barrier from the whole set of barriers and challenges identified for community-driven decision-making for risk-sensitive urban developments. these marginalised community groups include the ageing population, people with disabilities, seldom-heard youth, and minority groups [45] . however, as a contradictory view, [39] opined that it would be a mistake to assume that these marginalised groups would all be willing to engage with planning if the barriers were removed. it can be further commented that there is no reason to suppose that the seldomheard would be more motivated to participate than the apathetic majority [37] . six research contributions have highlighted that there are poor relations of communities with decisionmakers and urban planners [23, 33, 34, 40, 46, 47] . for example, a lack of a participation tradition is evident in eastern european countries in particular, where institutional cultures still place a low priority on participation rather than allowing citizens and stakeholders to actively contribute to the urban planning process and form its outcomes [40] . similarly, the participation of displaced communities in resettlement planning is also extremely limited, with city officials undertaking the whole process and only coming to the communities during displaced community registration [47] . in addition, some communities consider community engagement as a threat due to discrimination, fear of exposure to authorities (concerning drug use, immigration status, or stigmatising illness), and they see engagement as a means of diverting existing funding into other initiatives [33, 34, 41, 51] . apart from these highly cited barriers, there are seven barriers that represent the quality of existing relationships among communities and communities with decision-makers and urban planners. they are communities' lack of trust, respect, and confidence in the planning system [29, 31, 37] ; poor community headship [52, 53] ; unfair community representation [35, 54] ; competing agendas across stakeholders within partnerships [33, 37] ; both the communities' and the organisers' limited understanding of participants' roles and responsibilities [37] ; no recognition of community rights and responsibilities by decision-makers [37] , and some community members being involved in informal political networks to gain their benefits rather than having a collective and long-term approach for urban development [32] . in terms of organisational context, dominant organisational cultures, officials' negative attitudes and bad practices constrain communities' participation in sustainable development projects. from the seven barriers gathered under the organisational culture, attitudes, and knowledge, two of them are ranked in the fourth place when viewing all the 48 barriers identified. firstly, there is the factor current continuous top-down and centralised management of government authorities [6, 25, 33, 41, [54] [55] [56] [57] [58] causes resistance to sharing power and control with community actors [54] . secondly, many researchers [26-29, 33, 36, 37, 59, 60] stated that the existing organisational commitment for community engagement is extremely low. it is evident that for some developers and local authorities, engagement is too often a matter of managing expectations rather than evidence of a real commitment to reach out to communities and to listen and respond to what is said [37] . furthermore, there is not much evidence of a willingness to change policies or amend development proposals to reflect the views of communities [37] . fung [55] also is of the opinion that current procedures only have an extremely limited discussion on the role of third-sector organizations (such as voluntary associations, non-governmental organisations (ngos), community organizations, and non-profit organizations) in supporting community development activities. other barriers classified under this theme include professionals' lack of understanding on community engagement tools and techniques for specific circumstances [40, 45, 50] ; professionals' lack of knowledge and skills on participation techniques and participation competences [40, 62] ; official attitudes towards seldom-heard people [42] , and professionals' inflexibility in terms of finding a common agenda with the community [36] . in addition to the above discussed critical context-specific barriers and challenges to community-driven decision-making in risk-sensitive urban development, the study gathered another 10 barriers relating to the infrastructure for community engagement. these barriers and challenges lean more towards investments in infrastructure and planning to support community engagement. of these constraints, the most cited barrier in this theme is the lack of appropriate training for professionals to conduct community engagement and development programmes, particularly with regard to training on how to incorporate communities in participation mechanisms [24, 26, 28, 29, 31, 33, 37, 60, 63] . therefore, the literature emphasizes that more investments are needed for professional capacity building and development programmes. secondly, current community representation in urban development processes has been hindered due to the less information being available to the citizens [24, 26-28, 30, 45, 52, 64] ; most particularly, information on government meetings and familiarity with government officials, and knowledge about government affairs [30] . it is further argued that these information are not presented well due to ineffective methods of disclosing information and the difficulty of obtaining information at the local level [26] [27] [28] 31] . limited financial resources allocated for community participation [6, 26-28, 31, 40, 62] is highlighted as the second top barrier under investments. fulfilling budgetary requirements is key to the success of any implementation. in addition to financial investments, there is also limited availability of other resources required for community participation. these resources include a lack of knowledgeable and experienced professionals as well as venues and material for workshops [26-29, 36, 54] . poor community engagement is further exacerbated by weak communication channels, particularly, between decision-makers and communities [6, 26-28, 31, 64] ; rural isolation due to weak community infrastructure; poor roads and transportation [6, 38, 45, 52, 65] ; a lack of participation mechanisms to achieve consensus in an efficient manner [26, 28, 66] ; shortage of dedicated staff to engage with communities [33, 34, 67] ; unavailability of appropriate technology for supporting effective community participation [43] , and a lack of appropriate training for communities for engaging with decision-makers in urban development processes [33] . the third area on process consists of 13 barriers to community entry and challenges for community engagement in sustainable development plans. seven out of 10 barriers are gathered under the theme of the stakeholder engagement process while the rest of the barriers (6 barriers) are listed under inclusive and accessible practice. many researchers are of the view that the aim and purpose of community engagement are ill-defined due to lack of clarity (mixed messages) and lack of transparency: consequently, these status quo cause confused expectations [2, 25, 28, 29, 33, 36, 37, 52, 56, 68] . of all the 48 barriers identified, this is the third most cited challenge for community engagement. additionally, current engagement processes provide communities with only a limited time for building trust with decisionmakers and urban planners to establish participatory suggestions and achieve results [25-28, 33, 37, 60, 68] . this may discredit any efforts taken for participative decision-making and thereby wipe out the informed engagement of communities. it is known that current decisionmaking processes in city developments are hugely complex and, therefore, some tensions and conflicts of interests are inevitable [24, 26, 28, 29, 31, 37, 63] . such tensions are ranked as the third challenge within stakeholder engagement processes. although 4 out of the 7 barriers have been cited less, it is noted that existing stakeholder engagement processes are less effective due to: weak administrative structures in local government to support community participation [24, [26] [27] [28] 40] ; uncoordinated national development policies [58, 69] ; an absence of meaningful evaluation of community transformation and project success [43, 53] , and conflictive objectives between governments and communities [37] . improper coordination of event logistics [26, 28, 29, 33, 36, 43, 68] is the most commonly cited challenge for inclusive and accessible practice. in particular, some people cannot physically reach the planned venues for community participation due to geographical boundaries [33, 68] and limitations relating to access (e.g. transport, event timing, safety, and accessibility to the location of meetings) [26, 28, 29] . inclusive and accessible practice is further hindered when the information is not provided in a format that can be clearly understood by the community in order to understand what is being proposed and thus contribute effectively [36, 43] . incomprehensible information provided to participants is often hard to understand due to technical language and the inconsistent use of terminology [24, 26, 29, 31, 36, 37] . the next most argued challenge in this theme is failures in the community participation structure [43] . overlooked participation, the exclusion of seldom-heard people [37, 45] , unrepresentativeness and partisanship among community representatives [33, 34] cause an imbalance of stakeholders in the participatory process. furthermore, such an imbalance can occur between interest groups (who can strongly communicate their opinion) and weaker community members (who have difficulties in communicating their interests in the process) [40]. alongside the above discussed commonly cited barriers and challenges to inclusive and accessible practice in the participatory decision-making of risk-sensitive development projects, the study found another three challenges which are less cited. these challenges are the exclusion of: some communities due to cultural and language issues [33, 34] ; seldom-heard people and not encouraging the apathetic majority for engagement [33, 60] ; and community champions or leaders due to administrative delays [33] . the study found several possible solutions and recommended best practices to overcome some of the barriers discussed in section 4.1. these solutions and best practices are listed in table 5 . community training to involve citizens in formal government procedures [66] early advertising of engagement opportunities through multiple channels to increase awareness [33] educate communities of the importance and benefits of participation and let them feel that the processes are transparent and worthy of their trust [36] conduct community development programmes to overcome poverty [70] offer additional incentives such as welfare facilities to participate [37] quality of existing relationships: intercommunities and between communities and policymakers negative experiences from previous participatory decision-making events make both communities and decisionmakers less interested in community engagement. this factor represents untrustworthy relationships: among different types of stakeholders; between communities, between communities and decision-makers and urban planners. establish working groups to identify barriers to involvement in planning [37, 49, 71] communicate regularly to discuss the scope and potential influence of the participation process [2, 36] implement the knowledge-based urban development (kbud) paradigm to increase trust [72] third-party rights of appeal for communities should be introduced to empower communities [2, 71] community councils should be given a statutory right to be consulted on development plans to address the power imbalance between communities and decision-makers [71] develop a strong social capital (e.g. improved communication and cohesion between different groups residing in one settlement, strengthening existing or establishing new social networks such as self-help groups, youth clubs etc.) [6] organisation al culture, attitudes, and knowledge organisational boundaries and little experience in working across scales make professionals physiologically and practically backward in accepting community representatives within decision-making in government procedures. decentralised decision making, with responsibilities spread over different stakeholder organisations [40] implementing a multi-disciplinary approach that takes into account the dynamic relationship between the bottom-up and top-down dimensions [73] a continuing commitment to early engagement of communities in planning [71, 74] new institutional discussion forums operating on urban scales are required for effective participation [75] offering opportunities for community decision-making and partnerships [50] public bodies must demonstrate a willingness to trust the public and take the results of participation seriously [36] strengthen accountability and inclusiveness by devolving authority to the local level communities and their representatives [75] a review of the skills and participation competences of the administration use of citizen science to identify community challenges and solutions [76] allocate enough time and resources to sustain communication channels between different community groups [66] use mass media (e.g. newspapers printed in main local languages) as an important information channel and agenda-setter [77] use social media and mobile applications as a means of communication [43] establish a fixed budget for community participation [2] personnel, time, and financial resources need to be reviewed and assessed [40] use of horizontal initiatives such as shared funding among departments to encourage collaborative working [52] provide a forum to encourage dialogue, share information, and create strategies and actions that promote rural development [52] investment in improving human capital (e.g. providing education and vocational training and increasing awareness) [6] p r o the existing engagement process appears to be complicated with illdefined aim and objectives, no proper timeline, weak administrative structures, and policy breakdowns. planners and policymakers should not set unrealistic targets for participation [37] related laws and regulations regarding the community participation process in the municipal processes and services should be issued [66] ensure giving sufficient time for obtaining the results from new participatory organisations for sustainable development [2, 35] c e s s use of three key measures for the evaluation of community suggestions regarding urban development: (1) public satisfaction; (2) a better final product; (3) community empowerment [43] communities should be empowered to bring forward local place plans, and these plans should form part of the development plan [71] use of quantitative participatory methods and participatory numbers to identify appropriate stakeholders [7] stakeholder mapping for integrating different forms of knowledge [7, 40, 76, 78] implementation of co-production models [79, 80] focus on making the planning process more accessible, user-friendly and relevant [37] generate community engagement processes that can adapt to a variety of urban, regional and rural settings [38] careful preparation of the consultation process [40] inclusive and accessible practice community participation structures finalised by decision-makers are not always productive since they have the potential to exclude some communities due to event logistics, partisanships, cultural and language discriminations, and administrative delays. consider (a) the timing of events, childcare provision, wheelchair access and transport, and (b) how events are publicised, how the material is distributed, jargon-free language, braille and large print formats, translation into other languages [36] using familiar places and creating an informal atmosphere [33] the community engagement activity needs to go out into the community [43] plain language and provision for non-native language speakers [33] determine: who should be involved; what form of participation is appropriate, and when to involve [36] among the solutions mentioned to overcome the incapability and incapacities that exist with communities, the most significant actions to be taken are (a) to conduct training for communities on formal government procedures, and (b) to practically focus on participation strategies in municipal planning and budgeting processes [66] to improve community knowledge. early advertising of engagement opportunities through multiple channels [33] is suggested to improve community awareness of the purpose of, and the community's role and responsibilities in, inclusive developments, and how they can be of benefit to communities. while there are no simple answers to problems of consultation fatigue, interest will probably increase to the extent when people see the relevance to them of participating and feel that the processes are transparent and worthy of their trust [36] . community involvement in urban development interventions also entails some costs in terms of their time, labour and resources. consequently, this circumstance limits the participation of poor communities in urban development initiatives especially when such involvement requires a cash contribution [52] . the study conducted by [70] strongly indicated that the interventions of community development programmes through the formation of community organisations can significantly decrease the prevalence and depth of poverty. local governments can provide financial or other forms of incentives for community members to encourage their participation [37] . furthermore, a few solutions were found to improve the quality of existing relationships: inter-community, inter-departmental, and between communities and decision-makers and urban planners. working groups can be established to facilitate the representation of various community and institutional stakeholders in development processes to improve the quality of community engagement [37, 49, 71] . in addition, regular communication is required to discuss the scope and potential influence of the participation process [2, 36] . it is suggested that the implementation of the kbud (knowledge-based urban development) paradigm [72] not only increases community trust but it also eliminates negative perspectives on participatory approaches. kbud perspectives can inspire city authorities to put technology at the service of the public to motivate socio-economic interactions and propel the city into its knowledge-based future (e.g. e-governance, equal access, and knowledge of ict usage) [72] . socio-economic networks can either directly or indirectly engage the public in knowledgeintensive activities and, in return, foster public trust [72] . in addition, third party rights of appeal should be introduced [2, 71] and community councils should be given a statutory right to be consulted on development plans [71] in recognition of community rights and responsibilities. the literature indicates a diminishing of links among different community sectors and, therefore, it is necessary to take measures to strengthen the social capital [6] ; for example, improve communication and cohesion between different groups residing in one settlement, and strengthening existing or establishing new social networks such as self-help groups and youth clubs etc. existing top-down governance and organisational boundaries is a highly cited barrier in the organisational context, and many researchers have suggested implementing a decentralised decision-making system, with responsibilities spread over different departments, as a potential solution to address this barrier [40] . a multi-disciplinary approach that takes into account the dynamic relationship between bottom-up and top-down dimensions is needed to understand the contemporary challenges to participatory decision-making [73] . a multidisciplinary approach draws attention to the interaction between top-down factors (as normative pressure from global society) and bottom-up factors (as localised political challenges) and the potential tensions and trade-offs that exist between them [73] . a continuing commitment of professionals with new institutional forums operating on urban scales may be required [74] for effective inclusive decision-making. it is, furthermore, important to develop professionals' attitude regarding offering opportunities for a community to take part in decision-making and partnerships [50] and to trust the public and take the results of participation seriously [36] . as a solution to current issues with accountability, powers of authority can be devolved to local level communities and their representatives to strengthen accountability and inclusiveness [75] . the skills and competences of administrative people are required to review, and to identify, areas to be developed and experts from various disciplines (such as community engagement, community empowerment and participatory approaches) should be recruited to ensure the quality of decisions taken and meaningful engagement with the public [40] . as most nations do not have a national act on community engagement, it is recommended to take measures to implement the main elements of effective community engagement as put forward by international community empowerment acts [37] which would promote six elements: inclusion, support, planning, working together, methods, and communication. a lack of appropriate training for professionals to conduct community engagement and development programmes was found as the most cited barrier within an infrastructure setting for community participation. therefore, it is important to organise frequent professional development programmes for decision-makers. it is recommended that investments should be made in improving human capital (e.g. providing educational and vocational training and increasing awareness) [6] for both professionals and communities. it has been recommended that the information gap between communities and administration can be addressed by applying citizen science approaches since these approaches can help to generate more equitable and cooperative relationships between experts and laypeople [76] . it is further suggested that communication should be reinforced within communities (as well as between communities and decision-makers and urban planners) by allocating enough time and resources to sustain communication channels [66] , and by using mass media [77] , social media and mobile applications [43] . additionally, even though it is a challenging task to determine and retain a sufficient amount of capital to support community involvement in urban development, it is recommended to have a fixed budget for such a project [2] . it is suggested that there should be a review and assessment of personnel, time, and financial resources [40] periodically, while the issue of limited resources can be further managed by implementing horizontal initiatives, such as shared funding among departments [52] . the rural isolation of some communities can be addressed by introducing a forum to encourage dialogue, share information, and create strategies and actions that promote rural development [52] . of all the process-centred barriers and challenges, the most highlighted barrier is the unclear, non-transparent and confused aim of community engagement, which can be solved by introducing clear laws and regulations for the community participation process [66] . it is also important to set more realistic targets for participation [37] and allocate enough time for community participation [2, 35] . in addition, the stakeholder engagement processes should be armed with an effective method of evaluating public satisfaction, the equitability of the final product, and community empowerment [43] so that the value of participatory approaches can be measured and demonstrated. furthermore, communities should be empowered to bring forward local place plans, and their plans should form part of the development plans [71] . in addition, the current participatory processes can be further improved by the pre-determination of correct stakeholders with the use of quantitative participatory methods (such as ranking, counting and scoring, enumeration, mapping, piling, timeline and calendar, pair-wise ranking and matrixes, measuring, and venn diagrams) for the better integration of top-down and bottom-up actions in drr [7] . early participatory mapping [7, 40, 76, 78] and the implementation of core-production models [79, 80] will help to integrate different forms of knowledge for the successful accomplishment of inclusive developments. it is further recommended to make the planning process more accessible, user-friendly and relevant [37] , to generate community engagement processes that can adapt to a variety of urban, regional and rural settings [38] , and to undertake a careful preparation of the consultation process [40] to improve stakeholder engagement processes. in terms of inclusive and accessible practice, there is a big emphasis on running engagement events at convenient times and places, in conjunction with offering childcare and other facilities such as wheelchair access and transport [36] . to reduce the financial burden, planners should seek to bring community engagement activities to community places [43] . it is further recommended to use familiar places and create an informal atmosphere to make communities feel at ease [33] . in addition, plain language and provisions for non-native language speakers will increase community understandability and inclusivity. moreover, it is a crucial need to have an inclusive participation structure and, therefore, it is recommended to determine early on who should be involved, what form of participation is appropriate, and when to involve participants [36] . this research set out to conduct a comprehensive, structured literature review to establish a sound understanding of the current challenges and barriers to community-driven decisionmaking in disaster risk-sensitive urban development, and the potential solutions to overcome them. the study found forty-eight (48) barriers and challenges with regard to inclusive development related to community engagement under the categories of context (community capacity, quality of existing relationships, organisational culture, attitudes and knowledge); infrastructure (investment in infrastructure and planning to support community engagement), and process (stakeholder engagement process, inclusive and accessible practice). among these barriers, the lack of communities' knowledge on how best to engage in participatory decision-making in development processes as well as a lack of awareness of the benefits that they can gain through community engagement was the most highlighted barrier. the second most cited constraint was the absence or lack of meaningful engagement with communities by the decision-makers. ill-defined aims and purpose of community engagement, as well as a lack of clarity, a lack of transparency and confused expectations exist within present stakeholder engagement processes, came as the third top obstacle with regard to the inclusion of vulnerable communities in urban development. the study observed that the solutions for addressing context-specific barriers should be targeted at transforming the attitude and capacity building of both communities and professionals in community-driven participatory urban development. the study highlighted that most of the barriers are context-specific and, therefore, more efforts are needed to improve the community and organisational context. the study uncovered that there is an urgent need for building the organisational capacity of decision-makers to support the effective implementation of participatory decision-making to achieve equitable outcomes in urban development. the organisational context should be transformed by incorporating bottom-up dimensions instead of having dominant top-down governance, and decisionmaking and management powers should be decentralised with responsibilities spread over different stakeholder organisations. the infrastructure-oriented barriers should be addressed by investing in supporting community engagement activities, appointing experienced personnel to handle the engagement process, and establishing better communication channels with communities. furthermore, the process-related barriers need to be addressed by strengthening the participatory element within the current urban development processes and policies as well as including the appropriate stakeholders who can bring multi-disciplinary knowledge to the engagement process to achieve equitable results. this research also showed that there is a lack of legislative enactments or standards for community engagement. therefore, it is vital to make laws for public participation in decision-making while creating new, sensible policies and reviewing existing processes for required changes. however, attempts to realize community participation in current legislations have failed to adequately address the underlying factors such as clearly defined roles and functions of community representatives, effective and accountable channels for participation for communities to engage with government bodies, and training and capacity building needs of community representatives, which are crucial for promoting effective participation and enactment of legislations [81] . legislative enactments which are exclusively designed for community engagement in urban development projects should specify how and in which level the public participation is expected and meaningful, depending on the nature of development (i.e. residential, commercial, industrial or public infrastructure) as well as in which phase the community representatives need to be engaged in the planning process [82, 83] . as shown in figure 4 , the solutions identified have grouped in to three categories such as attitude transformation and capacity building, facilitating participatory decision-making, and process and policy changes. it is clear that these key groups of solutions identified are challenging and costly in implementation. furthermore, implementing community-engaged decision-making approaches for urban development may inopportune for many more years due to adverse influences of prevailing covid-19 outbreak and resulting global economic recession. for example, participatory approaches may be discouraged due to social distancing and public gathering restrictions imposed while finance for infrastructure development and planning support for community engagement would also be limited by the current global economic recession. public interest in collaboration may also be derelict due to loss of social gathering platforms. therefore, there is a need to investigate innovative approaches that exploit social media and other digital applications in facilitating community engagement. however, care need to be taken to ensure that vulnerable communities have access to such digital platforms as well as adequate knowledge in using such digitally driven community engagement solutions to avoid further exacerbation of the current situation. furthermore, the recent movements against racial discrimination has amplified the complexity in handling community engagement without prejudice [84] . therefore, much attention need to be given in managing the community engagement activities with a clear understanding of the sensitivities associated with racial discrimination. 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transdisciplinarity and co-production at stake? environmental science & policy citizens' engagement in policymaking and the design of public services rising to the challenge: public participation in sustainable urban development smart cities governance: the need for a holistic approach to assessing urban participatory policy making overcoming language and cultural barriers: a graphical communication tool to perform a parasitological screening in two vulnerable populations from argentina key: cord-026596-1kr5vmtf authors: baldwin, cathy; vincent, penny; anderson, jamie; rawstorne, patrick title: measuring well-being: trial of the neighbourhood thriving scale for social well-being among pro-social individuals date: 2020-06-10 journal: int doi: 10.1007/s42413-020-00067-6 sha: doc_id: 26596 cord_uid: 1kr5vmtf we report on a trial of the neighbourhood thriving framework (ntf), a conceptual framework from psychology and social science for measuring collective subjective social well-being. it combines the notions of feeling good and functioning effectively in a neighbourhood social environment in an indicator set of 15 conceptual dimensions. an online questionnaire was used to measure neighbourhood thriving (nt) among 212 pro-social volunteers involved in revitalising neighbourhoods in the uk city of stoke-on-trent between may and october 2018. exploratory factor analysis revealed 11 factors that made conceptual sense including three social epidemiological pathways to well-being, networks, participation and pro-social behaviours, and four criteria for flourishing societies, autonomous citizenship, safety, cohesive communities and resilience. the 11 sub-scales of nt showed satisfactory internal consistency reliability and preliminary evidence of construct validity. the sub-scales were used tentatively to examine nt among the volunteer sample, which showed the highest sub-scale score for positive regard and the lowest score for celebration. different levels of nt were observed among the community, with age and income positively associated with higher levels of nt. further validation work is needed before the nt scales can be used with confidence. validated scales offer potential benefits including: measuring nt preand -post project implementation; establishing which dimensions of nt are, and are not, working well in a community and need strengthening through further initiatives, and establishing which specific groups of people are experiencing lower levels of nt and designing projects that meet their needs. electronic supplementary material: the online version of this article (10.1007/s42413-020-00067-6) contains supplementary material, which is available to authorized users. the nff was devised by anderson. it comprised a preliminary indicator set of 14 features centred on the combined notion of social feelings and functionings at the group, not individual level, in relation to geographic or non-spatial communities. these were derived from huppert et al.'s (2006) individual well-being framework, based on current psychological theory, and developed for the european social survey (ess). it distinguishes interpersonal features (e.g. receiving help from others) from personal feelings (e.g. i feel happy). anderson introduced four additional features. the ess framework measured well-being among individuals. it evolved from developments in psychology where individual subjective well-being is conceived of as split between momentary experiences of pleasure or positive emotions (hedonic well-being) and more important, long-term and active processes of 'well-doing' (aristotle's eudaimonia) (see, e.g. keyes 2002; ryan and deci 2001; huppert and so 2013) . hedonia is theorised as a passive process of attaining the state of feeling good. eudaimonia is said to involve 'being holistically engaged, being challenged and exerting effort' (waterman 1993, cited in anderson and baldwin 2017, p. 316) , which meets needs rooted in human nature, such as the realisation of potential (waterman 1993; ryan et al. 2008, cited in anderson and baldwin 2017, p. 316) . huppert and so (2013) combined these two types of wellbeing -feeling good (hedonic well-being) and functioning effectively (eudaimonic well-being) -into an operational definition of individual mental well-being increasingly referred to as flourishing. they captured each form through an objective list of feelings and functionings. when compared with the results of a single survey question about 'life satisfaction', a traditional survey proxy for well-being, they found that the single measure lost much information and confirmed subjective well-being as a multidimensional construct (p. 839). whilst there are other indicator sets that combine hedonia and eudaimonia, they are not designed to measure neighbourhood-based flourishing, as shaped by the particular social experiences that people accrue by living in a geographically defined neighbourhood. the most widely used measures include the personally expressive activities questionnaire standard form (peaq-s) (waterman 1993) , the orientations to happiness scale (oth) (peterson et al. 2005) , the satisfaction with life scale (diener et al. 1985) , the scales of psychological well-being (ryff and keyes 1995) , and the hedonic and eudaimonic motives for activities (huta and ryan 2010) . while these scales provide general measures of hedonia and eudaimonia they do not indicate the sources of well-being and happiness and nor are they linked to neighbourhoods and local communities. with the exception of one item (positive relationships), huppert and so's scale did not address social well-beingwell-being at the group or community level, i.e. how the individual responds to experiences of the social environment which can affect their health (larson 1993; keyes 1998) . as individual local communities around the world face increasingly more frequent challenges that affect all members and put a strain on their daily social environment, (e.g. climate change, pandemics, and socio-economic crises), many people's well-being will be affected. well-being is a core component of group social resilience (zautra et al. 2008 ), a quality that communities can collectively cultivate that allows them to cope with, and respond effectively to these shock experiences. other essential components of social resilience are social capital (participation in networks for collective benefits) and social cohesion (cohesive relationships between social group/network members) (baldwin and king 2018) . whilst the individual members of a population may be feeling good and functioning effectively on an individual (personal) level, the same people might respond weakly at a communitylevel to a big challenge, (e.g. a natural disaster) (anderson and baldwin 2017) . strong communities experiencing high levels of well-being are more likely to develop the 'adaptive capacity' (berkes and ross 2013) to respond resiliently to challenges (baldwin and king 2018) . therefore, being able to measure (and maintain) a type of aggregated individual well-being that is grounded in shared social experiences (i.e. social well-being or flourishing), will be a key aspect of assessing and maintain community resilience. social health and well-being are recognised as a distinct phenomenon (e.g. larson 1993; keyes 1998; keyes et al. 2007 ) from individual psychological and emotional well-being (keyes et al. 2007, p. 100) , and physical and mental well-being (world health organization 1946 /1948 . whilst there is no widely accepted common definition, 'social health' (larson 1993, p. 287) describes the health of society and factors such as the distribution of wealth (mcdowell and newell 1987) , or the influence of social phenomena on individuals. the latter has been defined as: 'that dimension of an individual's well-being that concerns how he gets along with other people, how other people react to him, and how he interacts with social institutions and societal mores' (mcdowell and newell 1987, p. 152) . keyes (1998) proposed a conceptualisation of social well-being that situates an individual within social structures. that person evaluates their situation and personal functioning against social criteria (italicised), whereby they appraise themselves in the context of: 1) integration (relationship with community/society); 2) contribution (their social value and contribution); 3) appraise others: acceptance (trust in others); and appraise society/community: 4) actualisation (evaluation of society/communities' potential); and 5) coherence (perceived quality and organisation of society/community) (keyes et al. 2007, p. 100) . the original nff (anderson's work) built upon keyes' work, and aristotle's eudaimonia to argue that 'a well-lived life includes the quest for positive social lives, involving meaningful interaction with family, community and wider society'. going beyond individual psychological functioning, the presence of both social feelings (e.g. i feel close to my community) and social functioning (e.g. i feel supported by my community) reach beyond perceptions of one's self and represent a key part of positive social health. as public health scholars, we were also aware of the broader social epidemiology approach that situates psychological approaches to well-being within an epidemiological model of causal pathways between factors that affect human health and well-being, and health and well-being outcomes. social epidemiologists (e.g. kiwachi and kennedy 1997; berkman and glass 2000; kiwachi and berkman 2000; wilkinson and marmot 2003) charted causal pathways between the individuals' social experiences of the social environment, encompassing interactions with others within it for different purposes, and personal physical and mental health and well-being status. they explore pathways between individual and group experiences of processes described by sociological concepts such as social integration (as defined by keyes); social networks -the structures of society/community; social cohesion -the quality of individual and grouplevel relationships within networks; social capital -the ways in which networks operate to provide members with benefits; the provision of social support -a particular kind of network benefit; and individual and group-level health and well-being. both psychology and social epidemiology recognise the roles of the individual, others with whom they interact, and the social environment as determinants of social well-being (mcdowell and newell 1987, p. 152; keyes et al. 2007, p. 100; berkman and glass 2000; kiwachi and kennedy 1997) . the ntf uses proxy indicators, otherwise known as construct scales, which aim to measure the specific feelings and functionings that individuals experience at the interface between individual and social experiences. psychology focuses on the internal psychological processes that individuals experience during and through such interactions and processes during daily life. social epidemiology identifies the wider social processes and dynamics operating in broader community, societal and institutional contexts, and evinces concrete links to health and well-being. these approaches are combined in our conceptual framework. the dimensions of social well-being that we tested in this study, then, are the 14 conceptual dimensions in the nff and one additional dimension. they are described in table 1 below. we named this set of conceptual dimensions the neighbourhood thriving framework to differentiate it from other neighbourhood flourishing trials run by author anderson. each dimension was represented in our study by a set of 5-7 proxy indicatorscommonly known as 'items' in psychology questionnaires (see below). each item uses a statement for survey respondents to respond to by testing this framework on pro-social people rather than all residents of a neighbourhood, we had the following questions: 1) did pro-social volunteers' responses lead to any variations in the dimensions of well-being that emerged when exploratory factor analysis was performed? 2) to what extent did the resulting factor structure reflect the three social epidemiological pathways to well-being: networks, participation and pro-social behaviours? the neighbourhood is the geographic location of the local social environment, but within this social environment, there is a sub-network of pro-social volunteers aiming to produce reciprocity a balance between give-and-take or reciprocity in social exchange (i.e. perception of support from locals and providing help and support to them in turn) celebration two sub-features: the extent to which people feel that their local community values and actively celebrates (a) fellow members and (b) creativity engagement positive social relationships, that can be intimate or more informalas in more numerous but more superficial autonomy residents' perceptions of their influence over the local area and in shaping community life or activities, free from others people's control pro-social outcomes from their volunteer activity. each individuals' experience of volunteering occurs in social networks with fellow volunteers. equally then, 1) the volunteer network, 2) the wider social environment created through the interaction of people in neighbourhoods during voluntary activity, and 3) the prosocial activity, may all influence respondents' social well-being outcomes. accordingly, we adopted the social epidemiological emphasis (berkman and kiwachi 2000) on the social health and wellbeing effects of social networks and civic activity, identifying the three aforementioned possible causal pathways (each a sociological concept with sub-components) to an individual's positive social well-being matching the position of the volunteers in our study. social networks as non-spatialised communities are becoming more common (anderson and baldwin 2017, p.314 ) and volunteers were distributed throughout the city, although acting in neighbourhoods, conceptually, we focused away from geographic neighbourhood-based communities to communities-as-social-networks (see also berkman and glass 2000) as a sub-network within the neighbourhood. berkman and glass (2000, p. 141 -2) used a network approach to understand how the structure and function of social relations and networks influences health outcomes. they drew on the analysis of earlier anthropologists (barnes 1954; bott 1957) of the ways that networks 'cut across traditional kinship, residential and class groups' (berkman and glass 2000, p. 140) to explain the benefits that network members acquired such as jobs and political activity, and emphasises analyses of the structural qualities of the relationships among people in the network, its composition, and the type of resources that were available through it. social networks are linked to health outcomes through four sub-casual paths: through their functions in providing social support, the social influence of network members on other members, e.g. the provision of information on maintaining good health, social engagement and attachment, and the access that networks provide to resources and material goods (berkman and glass 2000, p.143) . social participation and engagement social participation and engagement is a related concept to 'network' that builds on its inherent abilities to connect people, and which is influential in social psychology, and the social and political sciences. it is described as 'a process in which individuals take part in decision making in the institutions, programs, and environments that affect them' (heller et al. 1984; florin 2000, cited in keyes et al. 2007, p. 98) . it involves people participating in a community context in social activities in networks, as shaped by local issues, the geographic location, and local 'culture, norms, values and institutions' (keyes et al. 2007, p. 98) . this describes the position of our volunteers. contributing to the community through participating and engaging with other participants has been linked to aspirations for life and well-being (keyes et al. 2007, p. 99-100) . berkman and glass (2000, p. 146-7) elaborated on an unclear pathway between social engagement and participation and positive health status. they saw participation as the face-to-face 'enactment of potential ties' in informal and formal settings where people take on social or occupation roles (e.g. as a community volunteer, as per our study, which can give them feelings of 'value, belonging and attachment'). participating in a social role within the network reinforces personal identity (berkman and glass 2000, pp.146-7) , provides company and sociability, and on the collective level, networks are a key feature of social cohesion, also a determinant of positive health status (kiwachi and kennedy 1997) . the authors found that 'contact with friends and family, and participation in voluntary activities' gives life 'a sense of coherence, meaningfulness and interdependence' (p. 147). they linked social participation and engagement indirectly via coherence and identity to improved levels of well-being, and directly various physical health outcomes. the participation and engagement aspect of volunteering could also contribute to our volunteers' social well-being. pro-social behaviours when people participate in social networks, a third pathway emerges between the actual prosocial behaviours and actions that each individual engages in, and the influence of these on their health and well-being, and that of an aggregation of their fellow community members'. ryan et al. (2008) have described the eudaimonic component of flourishing as a way of life. they reviewed a number of studies that collectively showed that people who live in a eudaimonic way are more likely to exhibit prosocial behaviour, thus benefiting themselves and other people in their wider community. individuals who undertake much social and volunteering activity have shown correlations with positive affect (the emotional component of well-being) and negative correlations with depression (larson 1993, p. 286) . in reverse, well-being itself is said to result in prosocial behaviour (huppert and so 2013, p.838) , so there is a hypothesised bidirectional pathway of influence. ryan et al. (2008) also found that 'conditions both within the family and in society more generally contribute toward strengthening versus diminishing the degree to which people live eudaimonic lives' (ryan et al. 2008, p139) . our study was able to test out this statement by exploring the extent to which stoke's social environment was associated with pro-social activity. the 14 conceptual dimensions from the original nff framework are mainly an extension of huppert et al.'s well-being frameworks for the 2006 and 2012 ess (huppert et al. 2012) . to these, author, anderson, added three further concepts: safety, participation and celebration. safety and participation were included in light of roger's (2003) substantive development of a social cohesion index and their absence from the ess model. celebration overlaps with roger's concept of creativity (community that encourages imagination and boldness) but also includes the notion of appreciation, and affection. we incorporated an additional dimension, 'affection', into the adapted neighbourhood thriving framework trial because loneliness and isolation are detrimental to mental health, and "friendliness" is a valued quality in uk communities. our aim in the present trial was to achieve sub-scales with a minimum of 3 items in each to provide reasonable reliability and validity of each sub-scale. to achieve this, baldwin and rawstorne devised 5-7 proxy indicators per dimension (subscale) in anticipation of the potential loss of proxy indicators during exploratory factor analysis (efa) and reliability analysis. where possible, proxy indicators were adapted from the ess (2006; 2012) , and existing national uk surveys, the citizenship survey (2010-11; uk data archive study no 7111), uk household uk household longitudinal study (institute for social and economic research 2014), ons social capital indicators review (foxton and jones 2011) and surveys from environmental psychology (e.g. williams and vaske 2003) and social epidemiology (e.g. cobb 1976 ). elsewhere, original proxy indicators were devised through discussion/refinement between the authors, with disagreement rare and discussed until agreement was reached. the survey questionnaire is in the appendix, and was reviewed by stoke project leads. face validity (i.e. proxy indicators appearing to measure what they are intended to measure) and content validity (i.e. proxy indicators measuring the full breadth of each construct) were built into the design of the proxy indicators measuring each sub-scale. a summary of the research process ranging from the utilisation of the neighbourhood flourishing framework through to the development of the neighbourhood thriving scale is depicted in fig. 1 . the study received ethical approval from the university research ethics committee at oxford brookes university, uk, and human research ethics committee at the university of new south wales (unsw), australia. we sought volunteers involved in pro-social/community activities at neighbourhood level, via a request circulated to public health authorities/community development organisations in uk cities/regions using our networks and online mailing list community empowerment evidence network ceen@jiscmail.ac.uk interest was received from aylesbury, sheffield, exeter and stoke-on-trent, and south wales. stoke-on-trent (hereafter known as 'stoke') (estimated population of 255,378 in 2017; 88.5% 'white' ethnicity) was selected because it is one of the most deprived cities in england -14th out of 326 local government authorities. over half the population (53%) live in areas that are among the 20% most deprived in the country (all: stoke-on-trent city council 2011). we also chose stoke as people in the city are generally disengaged on civic and organised community levels. residents demonstrate the lowest participation in volunteering (7.37% -just below the county's average) and lowest voting rate (54%) in the county (region) of staffordshire. social cohesion is challenging. just 60.8% of people say they believe people from different backgrounds get onthe national average is 76.4%. and 26.9% of people thought they could influence decisions compared to the national average of 28.9%. and 44.3% of people feel that people do not treat each other with respect, with a national average of 31.2% (staffordshire community foundation 2015). in response, stoke-on-trent city council public health department commissioned two community development projects in 2012 to reduce health inequalities through social action, each run by a separate community interest company (cic -a social business, with stated community benefit). a) my community matters (mcm) engages residents in social action in 10 neighbourhoods. in each, community development workers collaborate with residents, community groups, businesses and organisations to set up neighbourhood partnerships. they empower residents to lead community activities, to identify local assets, improve neighbourhoods and inspire further action. http://mcmstoke. org.uk/ neighbourhood flourishing framework = 14 conceptual dimensions of social well-being (within place-based neighbourhood) + 1 new conceptual dimension (affection) = neighbourhood thriving framework = 15 conceptual dimensions of social well-being each conceptual dimension represented in our questionnaire by 5-7 proxy indicators (items) * to what extent is it reflective of 3 social epidemiology pathways to social wellbeing: networks, social participation and engagement and pro-social behaviours? * = statements that represent the conceptual dimension being tested in our survey to measure social well-being that pro-social volunteers are asked to respond to international journal of community well-being b) 1000 lives network is a city-wide virtual network that was developed in response to demand from active citizens for opportunities to connect for mutual support to sustain their social action and engage others in volunteering. motivated residents, civil society and voluntary groups, and paid workers support volunteers and community groups. the network provides training in skills for community leadership, facilitates resource sharing, supports social action project start-up, and celebrates 'community champions.' by 2017, 1000 lives and mcm were in contact with a minimum of 2000 volunteers, but were unaware of how many participated in both. keen to gain a baseline measure of participants' social well-being (nf), they agreed to inform their networks about our online survey hosting the trial, and assist respondents to access it using mobile phones and computers. development of the neighbourhood thriving framework scale for social wellbeing involved several stages including: item development, piloting and revising item statements, as well as reliability and validity testing (including content validity, face validity, construct validity, and cronbach's alpha coefficient internal consistency reliability). item (proxy indicator) development occurred between december 2017 and january 2018. in the statements, we distinguished between the physical locality of a neighbourhood, and its human residents to make it clear which one we were talking about. we phrased this distinction in the questionnaire using terms taken from the two stoke initiatives: "by neighbourhood, we mean: the buildings and outdoor spaces where you live and/or work where you see local people". "by community, we mean: the people who live, work, study, volunteer, run services and businesses locally with whom you interact, other than your family". this distinction was stated before and mid-way through the 15 dimensions-based sets of statements in the online survey. the premise of our research was that volunteers conducted activities on a face-to-face basis within spatial proximity of each other, not a virtual one, hence the questionnaire did not address online activity. however, in conceptual research terms, there is no guarantee that the human residents of a physical neighbourhood will form any kind of network or social community. it is not uncommon in northern europe to find that people do not know or cooperate with their neighbours in any meaningful way. this norm may be changed significantly after the current covid 19 pandemic which is showing the importance of local cooperation and neighbourly relationships. the original nff in part sets out to measure what level of shared social experiences occur in any given neighbourhood, and how these impact on residents' social well-being. the stoke projects intended to galvanise residents to come together to work collectively on improving their neighbourhoods, and to enhance networks and feelings of social community. with this additional pro-social effort on top of the routine workings of neighbourhoods, how would this impact the final factor structure? the stoke-on-trent well-being survey questionnaire (sotwsq) was constructed for the purpose of collecting data for this trial and hosted by online platform qualtrics: https://www.qualtrics.com/uk/. respondents were guaranteed anonymity and gave their consent via an online form prior to completion. a downloadable sheet listing the contact details of the authors, community development workers from 1000 lives and mcm, and local mental health support services for respondents to ask questions or seek support should they experience any discomfort after completing the questionnaire was clearly marked beside the consent form. it was not expected that completing the questionnaire would result in adverse effects due to the gentle nature of questions, and no respondents contacted the team with questions. after responding to demographic questions, they were asked to answer 15 questions one relating to each dimensionby responding to 5-7 items per dimension by selecting an answer option for each from a 5-point likert scale, from 1) strongly agree, 2) agree, 3) neither agree nor disagree, 4) disagree, and 5) strongly disagree. the subscales are named in appendix a for reader clarity and have been re-labelled, but were not named or numbered as such in the questionnaire. some items were inverted at random to mix up the order of positive and negative statements so as to identify response bias (i.e. respondents ticking all answer options down the left-or right-hand side of the page). a full list of the scale items and their sources are provided in appendix a. we opted for a convenience sample of a minimum of 200 volunteers which was not randomised or stratified. volunteers' addresses were already known and there was no viable way of randomising their selection as relevant demographic information was unavailable. instead, the limitations of a convenience sample were accepted, and the following survey inclusion criteria were set for respondents: they should be aged 18 or over, live or work in stoke, volunteer with mcm, 1000 lives or another local community action group, and be able to complete the survey online. a pilot trial was run with the first 20 volunteers at a community meeting in stoke. they completed it on laptops (some with support worker assistance) following an introduction by authors baldwin and rawstorne, who visited. respondents provided verbal feedback on the pilot version of the survey and small changes were made to the wording of survey items for clarity, and incorporated into its final design. no items were deleted. project workers used their face-to-face contacts, email distribution lists, facebook pages, twitter, and community group webpages to inform volunteers about the survey and invite them to take part. online data collection for the full community trial took place in stoke-on-trent between may and october 2018. data collection for the pilot trial ran from late april to early may, and the community trial ran from early may to october 2018. the pilot data was not used in the final analyses, only the data from the trial. data cleaning was minimal since the instrument was administered via the qualtrics site with skips (routing) built into the programme. exploratory factor analysis (efa) using principal axis factoring with oblique rotation was performed on all 85 items, based on the responses of 212 participants who lived and/or worked in stoke-on-trent. cronbach's coefficient alpha was calculated for each factor to determine the scale internal consistency reliability as well as whether the reliability of each sub-scale could be improved by the deletion of any items. removal of items from scales was also informed by conceptual considerations. construct validity was tested in two ways: first, by correlating each sub-construct with other sub-constructs, after making predictions about the direction and strength of each association, and second by: conducting analyses between sub-constructs and other study variables that were expected to show a relationship or difference. once satisfied that the sub-constructs showed preliminary evidence of reliability and validity, we conducted further analyses of nt in stoke. many of the analyses, including those used to help describe the sample, were examined across two variables of interest: sex of participant and judgement about whether their neighbourhood had got better to live and/or work in over the preceding 2 years. a majority of the 212 participants were women (n = 144; 69%), and 66 (31%) were men (table 2) . over one-third of the sample participated in the mcm, while 50% were involved in projects other than mcm and 1000 lives (table 2 ). in answering whether their neighbourhood had got better to live and/or work in the prior 2 years, 65 people (31.4%) agreed to some extent, 56 (27.1%) were neutral, and 86 (41.5%) disagreed, thinking that their neighbourhood had got worse. the age of participants ranged from 18 to 86 with most between 35 and 64 years. most participants were living in households alone or with another adult (table 2) , mostly without children at home. three variables influenced perceptions of whether neighbourhoods had improved as a place to live/work. most people had lived and/or worked in their neighbourhood for at least 20 years (table 2) . those who had lived and/or worked in their neighbourhoods for longer than 20 years were more likely than others to think their neighbourhood had not improved in the preceding 2 years, ï� 2 (6) = 17,121, p = .002. a majority (53.3%) reported living and working in stoke (table 2) . those working in stoke were more likely than those who lived in stoke to report their neighbourhood had improved, ï� 2 (4) = 14.18, p = .007. most of the sample reported household income of less than â£52,000, while over one quarter opted not to reveal this. those who were in the highest household income group were significantly more likely than those in other income categories to believe their neighbourhood had improved, ï� 2 (6) = 12.647, p = .049 (table 2) . the exploratory factor analysis produced eleven distinct factors that made conceptual sense and accounted for 63.5% of the variance based on 65 of the 85 original items. the conceptual underpinnings of the new factors are described in table 3 below. the 11 new factors suggest three findings. firstly, there are six factors mirroring the social epidemiological pathways to well-being: networks, participation and engagement, and pro-social behaviours (included in the latter: collective positive effort, celebration, and optimism about the communitya pro-social state of mind). secondly, the factor, positive regard, mirrors an additional pathway outlined in the community psychology literature: affective attachments to community, and well-being. thirdly, the remaining four factors are all contemporary social conditions that can be deemed necessary pre-cursors to social well-being: social cohesion (cohesive societies and communities), safety, autonomous citizenship (individual autonomy safeguarded by the state), and resilience (current advents can lower resilience and well-being (e.g. deprivation, financial crises, climate change etc.) (baldwin and king 2018) . without these conditions present, positive well-being may be threatened. it is interesting to note that well-being in this scale is represented by pro-social attributes that individuals can experience in group social settings and activity, but also by the right underlying social conditions. eight more items were removed from four factors based on conceptual considerations and improvements to internal consistency reliability with their removal. the removed items and scales included: two items (par5 & par6) from the participation scale; three items (alt4, con3, con5) from the celebration scale; one item (bel6) from the social networking pathway to wellbeing scale, and; two items (alt2 & aff5) from the autonomous citizenship scale. after removal of these items, the 11 factors contained 57 of the original 85 items. with reference to anderson's original nff, two of the 11 factors resembled 'feelings' (safety; positive regard), while nine factors characterised 'functionings' (celebration, collective positive effort, optimism about the community; participation; social network pathways; social cohesion; autonomous citizenship). as shown in table 4 , internal consistency reliability, based on cronbach alpha coefficient, was sound for each of the 11 scales. the reliability coefficients were also stable for men and women, as they were for each of the three responses to the question about whether people believed their neighbourhood had improved as a place to live and/or work in the past 2 years. condition of the social environment for social well-being face validity and content validity were built into our study design by having content experts design the questions, which were reviewed by local community development practitioners. evidence of construct validity was assessed initially through the conceptually coherent factors that emerged from the efa. convergent and divergent evidence of construct validity was then assessed from the inter-scale correlations (table 5 ) as well as through the associations between each construct scale and participants answers to questions about changes in their community (table 6 ). as shown in table 5 , inter-scale correlations (pearson correlation coefficients) ranged from .19 to .77. while some scales showed similarity, a majority were not highly correlated, showing support for a lack of redundancy. the only scale for which a higher score was indicative of lower community wellbeing, low resilience, correlated negatively with all other scales, as expected. the strong associations between construct scales that we argue measure aspects of cohesiveness (e.g. social cohesion, collective positive effort, celebration, social network pathways, low resilience) provided some convergent evidence of construct validity. to compare the mean scores of each of the 11 factors, within-subjects analyses were conducted using glm. the total mean scores of each factor are reported in the total column in the left-hand side of table 6 . there was an overall difference across the factors at a multivariate level, f (10, 195) = 57.93, p < .001. pairwise comparisons showed the mean score on social cohesion was significantly (p < .05) lower than for all table 5 inter-scale correlations (n = 212) 1 1 2 3 4 5 6 7 8 9 10 11 to further assess preliminary evidence for convergent and divergent evidence of construct validity, participants scores on each construct scale were compared with the way they answered two statements about their perceptions of whether their neighbourhood had got better or worse, respectively, in the previous 2 years. for all scales we expected to see a linear relationship in scale scores across the three agree/ neutral/disagree categories for the two neighbourhood questions. those people who agreed with the statement that their neighbourhood had got better were expected to score higher on the nt scales (except for low resilience for which a higher score equates to lower nt) compared with those who disagreed with the statement. and the reverse was expected for the statement that their neighbourhood had got worse. the results shown in table 6 support the hypotheses: for all nt scales, there was a linear relationship in the expected direction with responses to both statements in each of the analyses using anova with polynomial contrasts. for the statement that their neighbourhood had got better, agreement with the statement was associated with higher nt scale scores while disagreement with the statement was associated with lower scores ( the reverse was true for the statement that the neighbourhood had got worse. agreement with the statement was associated with lower nt scale scores while disagreement with the statement was associated with higher scores (collective positive effort, f(1, 199) = 43.43, p < .001; participation, f(1, 199) = 9.83, p < .001; celebration, f(1, 199) = 28.49, p < .001; social network pathway, f(1, 199) = 24.48, p < .001; optimism about the community, f(1, 199) = 46.28, p < .001; social cohesion, f(1, 199) = 61.59, p < .001; engagement pathway, f(1, 199) = 39.92, p < .001; safety, f(1, 199) = 48.44, p < .001; autonomous citizenship, f(1, 199) = 28.30, p < .001; positive regard, f(1, 199) = 19.17, p < .001; low resilience, f(1, 199) = 26.17, p < .001). these results provide some preliminary evidence of construct validity. overall, the sample of pro-social volunteers did not endorse their neighbourhood as being a better place to live and/or work in compared with 2 years prior. anova with linear (polynomial) contrasts were used to test the relationship between the four age categories and each of the scale scores. as shown in table 7 , three of the scales showed a linear trend with age: participation, social network pathway, and engagement pathway. for each of these scales the significant trend was in the direction of neighbourhood thriving being positively (directly) related with age; older people experiencing neighbourhood thriving to a greater extent than younger people. participants who indicated their preference not to answer the question about their household income (n = 58; 27.6%) were excluded from this analysis so that an anova with linear (polynomial) contrasts could be conducted. these analyses, which included three household income categories, showed a significant trend with 9 of the 11 neighbourhood thriving scales: collective positive effort, celebration, social network pathway, optimism, social cohesion, engagement pathway, safety, autonomous citizenship, and low resilience. each significant trend was in the direction of a positive (direct) relationship between income and nt: the higher the income the greater sense and experience of nt. time lived and/or worked in stoke (analysed as three categories) were analysed against the nt scales using anova for between-subjects effects as such analyses explained the data more accurately than linear trend. scores on five of the 11 scales were associated with time lived in stoke: collective positive effort, celebration, social cohesion, safety, and autonomous citizenship. in each of these associations, except for social cohesion, those who had lived and/or worked in stoke for 10 to 19 years showed higher levels of nt compared with participants who had lived and/or worked there for less than 9 years or greater than or equal to 20 years. for social cohesion, there was greater nt among those who had lived and/or worked in stoke for 10 to 19 years compared with the people who had lived in stoke for 20 years or more. the type of presence people had in stoke (analysed as three categories: living; working; living and working in stoke) were analysed against the nt scales using anova for between-subjects effects. scores on seven of the 11 scales were associated with connection with stoke: collective positive effort, celebration, optimism, social cohesion, safety, autonomous citizenship, and low resilience. in each of these associations, those who worked in stoke only (i.e. did not live in stoke) showed higher levels of nt compared with participants living there, and those who both lived and worked in stoke. age ( missing (n = 38); 5 the last category -those who did not want to answer the question -was removed to enable linear analysis *p < .05; **p < .01; ***p < .001 international journal of community well-being our first trial of the ntf resulted in useable questionnaire data from 212 participants. exploratory factor analysis (efa) produced 11 conceptually coherent factors that were further refined through the omission of items that were not contributing conceptually or to internal consistency reliability. all scales showed satisfactory internal consistency reliability across the entire sample as well as separately for men and women and for all three responses to the question about whether participants thought their neighbourhood had improved over the previous 2 years. while face and content validity were built into the design of the scales, construct validation was limited to preliminary evidence only through inter-scale correlations and the relationships of the scales to two questions which asked participants whether they thought their neighbourhood had got better or worse, respectively, in the previous 2 years. inferring construct validity from these analyses is limited because the variables that were used to validate the scales against, were broad areas and not specific to each scale. as such, these associations are only able to confirm that the scales were associated with other factors in predictable ways. additional research is needed to validate individual scales against other known validated scales that are measuring similar constructs. until that happens and the body of evidence for construct validation builds, there must be caution in making inferences when using the scales. other validation work that is needed is in showing whether the scales can be used to predict (at least correlate with) behaviours consistent with a person's scores on each construct, and also examining whether a total nt score is predictive of behaviours. it will also be important for future studies to apply and validate the scales in populations that are comprised of people other than pro-social volunteers, particularly in random samples of local communities. until that happens, we cannot be sure of the stability of the scale structure for non pro-social populations. as such, caution should be exercised when seeking to draw conclusions from the results of administering the scale to non prosocial populations. notwithstanding the need for further validation studies, what do the new scales tell us about nt in our sample? caution is required in making any claims about levels of nt until further validation and norm scores are established. however, since all scale items were measured on a 5-point likert scale from 1 to 5, we offer some broad observations based on mean scores for the scales. with a mid-point of 3 on the 5-point likert scale, and based on higher scores for each of the scales (except for low resilience) indicating higher levels of nt, we can observe that the mean of each of the scales was equal to or above the mid-point, likely indicative of nt. the social cohesion scale was scored the lowest of all the scales which suggests many in the sample perceived social difference in their neighbourhoods as being somewhat problematic rather than as a richness to celebrate. the celebration scale was also one of the lowest scored scales, albeit above the mid-point, which suggests a relative absence of activities and events that recognise and celebrate community achievements. at the opposite end, the positive regard scale was scored highest of all the scales which indicates that people may have experienced a positive outlook towards others in their neighbourhood, perhaps because they are intimately involved in revitalisation activities. as for who appears to be experiencing the greatest levels of nt, the results indicate it is positively (linearly) associated with age and income: older people and those with higher household incomes. also, those who had lived and/or worked in stoke for 10-19 years showed higher levels of aspects of nt compared with those who had been living or working there for shorter or greater periods of time. the type of involvement was also important, with those who work in stoke showing higher levels of aspects of nt compared with those people who lived, some of whom also worked, in stoke. these results are consistent with findings from the 'ageing in place' literature (e.g. young et al. 2004 ) which often show that older residents are less likely to move from their long-term place of residence and feel attached to it, which may help explain higher levels of well-being. similarly, wealthier people are less likely to experience adverse living circumstances and associated stress, therefore demonstrate higher levels of well-being (wilkinson and marmot 2003) . those not living but just working in stoke could be hypothesised as more likely to live in pleasant surrounding rural areas. likewise, those in the middle 'length of residence' category had lived in stoke long enough to have evolved networks and experienced residential stability, but not so long as to become jaded with the deprived environment. it may surprise some readers that the sample of pro-social volunteers in this study did not confirm their neighbourhood had become a better place to live and/or work in over the previous 2 years. there are some plausible reasons for this finding. one explanation is that people who volunteer to try and improve their social environment are motivated by observing that their neighbourhoods could become more pleasant places to live and work. without that observation and viewpoint, it is unlikely people would be motivated to volunteer for such roles. as such, one may conclude that a sample of pro-social volunteers are likely to be the harshest critics of their social environments as they are the ones who observed that change was necessary and chose to act upon that realisation. this is another reason why it is important to sample from a broader cross-section of the community to gauge wider-held community perceptions of changes in the neighbourhood. since the current study did not set out to evaluate the two community development projects that were commissioned by stoke-on-trent city council public health department in 2012 to reduce health inequalities through social action, and because the current sample comprised pro-social volunteers and not a broad cross-section of the community, we are unable to ascertain the specific benefits of these programmes to their communities. however, the 11-factor nt scale that emerged from our research revealed social conditions key to social well-being in the local social environment. future community development programmes should aim to address these conditions: the first three of which can be cultivated through local action: social cohesion (through structured mixing of people from different backgrounds in collaborative activities), safety (through design efforts to transform urban environments with poor street lighting, poor traffic control, and no eyes on the street, and the targeted reduction both crime and violence, and their risk factors), and resilience (through cultivating social capital, social cohesion, well-being and the eradication of inequalities). autonomous citizenship is both a national and local benefit that individual volunteers may experience feelings of it if, during civic action, they can express themselves freely, their fears for safety are allayed, appreciation is shown for volunteers' input, and a feeling of community spirit is garnered. in this paper we have taken steps towards developing a neighbourhood thriving scale underpinned by various sub-scales. each sub-scale showed satisfactory internal consistency reliability and early signs of construct validity. more validation work is needed on these scales, particularly with non pro-social volunteers, before they can be used with confidence to measure the 11 dimensions identified in the study. when these measures were applied to a sample of pro-social community volunteers in stoke, we observed the highest scale score for positive regard and the lowest scale score for celebration. gauging levels of nt through comparison with other places will be made possible once further validation and norms are established. we also observed a positive relationship between age and income with neighbourhood thriving, suggestive that nt may not be experienced equally and to the same extent by all stoke residents. the scale may develop into a useful tool for evaluating the success of community projects when administered pre and post project implementation. it may also be useful for gauging which members of a community are experiencing low levels of nt and to tailor the design of projects at different groups of community members and their needs. conflict of interest the authors declare that they have no conflict of interest. open access this article is licensed under a creative commons attribution 4.0 international license, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the creative commons licence, and indicate if changes were made. the images or other third party material in this article are included in the article's creative commons licence, unless indicated otherwise in a credit line to the material. if material is not included in the article's creative commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. to view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. building wellbeing: neighbourhood flourishing and approaches for participatory urban design intervention social sustainability, climate resilience and community-based urban development: what about the people class and committees in a norwegian island parish community resilience: toward an integrated approach social integration, social networks, social support and 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validity and generalizability of a psychometric approach constitution of the world health organization the sense of belonging to a neighbourhood: can it be measured and is it related to health and well being in older women? community development and community resilience: an integrative approach publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations key: cord-323466-r0n7448g authors: núñez, ana; madison, maria; schiavo, renata; elk, ronit; prigerson, holly g. title: responding to healthcare disparities and challenges with access to care during covid-19 date: 2020-04-14 journal: health equity doi: 10.1089/heq.2020.29000.rtl sha: doc_id: 323466 cord_uid: r0n7448g nan viruses know no boundaries, but the impact of pandemics highlight faulty health systems and at-risk individuals. the novel coronavirus of 2019-2020 pandemic has hit certain groups of people within the united states more severely than others. those living in underserved areas, often with financial hardship, and black and brown individuals, are more prone to experience sickness and death from the virus. this roundtable discussion brings together several experts from various fields related to health equity to address these disparities and recommend actions needed to attain equity. dr. ana nú ñ ez: i recognize that identifying one top ranking priority is a challenge, as there are many. that said, what is your top-ranking priority during this current covid19 pandemic? what item most needs to be realized or addressed? dr. ronit elk: my number one priority is how culture influences and fundamentally shapes how people make meaning out of illness, suffering, dying, and death are, and how culture strongly influences people's response to getting a diagnosis to an illness, as well as treatment preferences. and the problem is that we have a lack of appreciation in the u.s. for the cultural differences that may and in fact do compromise care for seriously ill minority-i call them patients, but people. and that is my number one priority. dr. maria madison: thank you so much, dr. elk, for your comments, because my number one priority is fairness. when i think of fairness, i am thinking of investing in equitable access to prevention, mitigation, and treatment for covid. that includes looking out for the most vulnerable populations and their needs for basic things, including clean water. when we say prevention is easy, that we should wash our hands for 20 seconds, it is easy to forget that a large proportion of the population in the u.s., if not the world, does not have access to clean water, or the internet access to learn about best practices or threats to our food supply, but even more importantly, in order to assure that we try to protect our frontline workers, personal protective equipment (ppe) supply chain, investing in vaccines, or even investing in evidence-based treatments. so for me, the number one answer has to focus on promoting equity for all the reasons dr. elk just described. right now, we are seeing that a disproportionate number of people who are suffering and dying from covid-19 are black and brown folks. we can dig deeper into why that is when we get to the other questions, but it really draws attention to the inequity in our society that allows us to continue to oppress populations that are already at risk for all aspects of inequity. dr. renata schiavo: my number one priority is to protect marginalized and vulnerable populations from this pandemic and beyond. i feel pandemics have this very strong way of showing us how widespread social and health inequalities are, and how in the day-to-day they prevent people not only from protecting themselves, but also from leading healthy and productive lives. within the realm of vulnerable and marginalized populations, there are three main groups that come to mind as examples. first, there are children who live in poverty who may not be directly affected by the serious health consequences of covid-19, but in many cases depend on being in school for their only meals. the pandemic has shown that in addition to school-based nutrition, we need to think of additional systems to deliver child nutrition to the 20 + million children who live in poverty in the united states, especially in communities of color that have been marginalized and discriminated against for centuries, and experience high rates of poverty. the family first coronavirus act has tried to address these issues, but it is just a drop in the bucket compared to the needs we are facing. 1 the second group is the homeless population. we talk about social distancing and washing hands. these are very difficult behaviors for people who live in shelters or in the street. we have seen communities coming together and trying to install temporary sinks. but again, we need more comprehensive interventions. and third, of course, the communities of color who are more significantly impacted. we are already seeing that the highest mortality is within black and brown communities. this has to do with a history of lack of investment in communities of color, poverty, racismplease let's use that word, and a variety of other issues that have determined a higher burden of health and social inequities. i will stop it here, but again, it was very difficult to talk about one priority, so i decided to make an example of populations within the ones that we need to protect. dr. nú ñ ez: thank you. dr. holly prigerson: i direct the center for research on end-of-life care at weill cornell medicine. although my focus is on disparities, i have concentrated my research mostly on psychosocial influences on the poor or inadequate care at the end of life. my focus has been on mental health issues and how patients and families might feel abandoned, as well as how poor communication and lack of resources to attend to psychosocial needs are often overlooked in life-threatening illness, especially for marginalized patient populations and families. i look more at the intersection of how psychosocial influences might be affected and impact access to care, receipt of care, feelings of injustice that some people might have gotten a ventilator whereas other people may have been denied a ventilator. we are trying to leverage the available resources that we know exist to try to remove barriers to better care for everyone, but by targeting a lot of the psychosocial issues that we think really account for who gets what. augmenting much of what you all said, the area that i see and feel that is the priority from my perspective is something that sounds sort of simple: process. there is not a coordinated, integrated, thoughtful process right now. instead, we have this patchwork of competition where every institution and individual has to figure it out independently. the fact that there is not a coordinated and integrated approach that oversees this pandemic speaks to the fact that we only have a public health finance structure. we do not actually have a functional, robust public health infrastructure. this void increases adverse health risk for vulnerable, marginalized populations and stresses these populations and the system. it's very difficult to ignore this impact now because we are seeing the exposure of vulnerabilityrisking mortality rates is just one marker-which really speaks to the pressing issues of need for integration and coordination of public health and prevention. ultimately, it will affect everybody. the question is, is this our opportunity to take this challenge as an opportunity to do things differently, or do we go from here and not make the needed changes that can put us all in a better position? dr. prigerson: by saying ''process,'' that sounds more macro, conceptual, zoomed-out kind of approach. and i think related to zooming out, i would say communication is important as well. by ''communication,'' i am referring to barriers to effective communication to decision-making, to getting care, to receiving care, to working with families at home to connecting families with work and employment. it is communications about medical decisions but also more mundane responsibilities such as going to shop for food and pick up cleaning supplies and all the sort of ways in which this covid-19 has affected our lives. communication, and in particular, telecommunication appears to have become a normal part in the way of life for many of us. right now, this is how we are all communicating with each other, but it is important to bear in mind that access to telecommunications for certain communities might not be available. maybe health literacy might affect communication and understanding of medical choices before making decisions. i think communication is a key aspect in how this pandemic has adversely affected different communities. dr. madison: yes to ''process'' but it must be fair process. as of the time we are having this discussion, we are seeing states like alabama and washington creating triages that some are calling ruthless utilitarianism, because they are singlehandedly creating hospital practices with a process that may be likely to inhibit treatment and care for certain groups, again, including our most vulnerable populations. that is why we are seeing high rates of morbidity and mortality for black and brown folks. dr. elk: so most of us have defined the problem in terms of what is happening. i would like to discuss, when we get best practices, what happens in the hospital, because this is where the physicians and nurses and ethicists and so on, have to do. i will talk about how to make advance care planning decisions and how to incorporate leaders. my expertise is with african american communities. you must incorporate pastors in your ethics committees. if you do not do that, you could be doing something morally wrong. in the united states, they do not give sufficient respect to the pastors, who are not only leaders in terms of faith and spirituality, but in terms of everything else. dr. schiavo: i want to add something to what dr. prigerson was saying about the importance of communication in this moment. some of the main principles of communication, and especially risk communication, are trust, transparency, and community engagement. a lot of communication has not been meeting these principles because it has been conflicting. it has not included community leaders who actually have the real understanding of the communities for which this communication is intended, who are trusted sources. often these are the individuals who really know best about the needs, preferences, and priorities of specific communities, such as communities of color, children, and other populations. we need really to think of risk communication not as the rem-edy when things go wrong, but something we should be prepared for in advance, during inter-pandemic times. dr. nú ñ ez: currently we are overwhelmed by news and social media activity. an important question for me is, how do vulnerable populations identify trusted sources of communication? dr. prigerson: we are actually trying to develop what we call a ''divine intervention'' that capitalizes on the trust that we have found that healthcare chaplains and hospital chaplains have, particularly among our black patients with advanced-stage cancer. in our studies, what we have found is that for whatever reason -we do not know the mechanisms -but when very sick, dying patients seek a hospital chaplain, they are more likely to sign a do not resuscitate order. they are less likely to die in an icu. they are more likely to enroll earlier in hospice. we have been trying to understand this, but we suspect it has to do with feelings of trust that may lead to an enhanced ability to communicate. leveraging the power and influence that healthcare chaplains have in this crisis might be effective. we think this may be a missed opportunity, because healthcare chaplains have the ability to understand where people in their communities are coming from, as well as talk the talk to physicians. dr. elk: there are two things i think are key and that may be promising aspects. one is in terms of transparency and reaching out to the community. at the university of alabama, birmingham, i have been involved with the school of public health, where we have reached out to the black pastors, housing authority and the dean of the medical school, who himself is black, and have set up a series of webinars. the first webinar was on saturday, april 6, 2020. 2 there were 1,500 people on the webinar. many of the people were from the housing authority, just regular people. many others were black people from the community. the whole point was to discuss all these issues. there were specific goals with this webinar: one was to help people in the community understand how this illness progresses and so on, and our dean did speak about that. a little bit too much jargon, but okay. and then, the other goal of the webinar was to educate participants on how to protect themselves. i am hoping that i can partner with the housing authorities and we can create culture-based messaging, because creating messaging that the white man and the white middle-class has developed for the large audience does not work. we know that. so i wish we would stop doing that. and so we did create culture-based messaging, and we are going to continue to do that. what i am begging hospitals to do is to include leaders who are black, alongside other ethnic groups, on ethics board before making decisions on protocol for care allocation. failing to do that is failing to care about the black population and can lead to lawsuits, which is discussed heavily if bottom dollar is what the institution cares about. i do not care if you have already got a policy. change it. revise it. the other thing is, there is a lot of pressure in the united states for having a written advance care directive. that is not going to work in the black community, particularly in the south. if i sign something saying, ''do not resuscitate my mother, you will do nothing. as it is, you do nothing for our people. why should i sign a piece of paper?'' so do not pressure people. and if i say that culture influences how you make decisions, in the black community in the south, it has been shown that millions of people have held belief in the concept of, ''there could be a miracle. god can make a miracle happen.'' i do not know why people have such difficulty with this, since so many people read the old testament, where the word ''miracle'' is everywhere. but it is very, very difficult for physicians to understand this concept. if a miracle can happen, then you have to do everything that you can for the patient until they decide. another thing is that nobody dies alone in the black community. there will always be a pastor or somebody who will sit with them. in this time of covid-19, we have people sitting alone. there are a couple of practices that i have seen that could be used. one thing that can be done is to have someone sit with the patient, remembering that this is somebody's loved one. yes, it may take hours, and yes, there are other patients to care for. but there is always someone who can sit there and be with the person and pray with them and maybe sing a church song with them. that act can be tremendously meaningful. the other thing is funerals. we know what happens at funerals. it is not only blacks. in israel, they have had the ultra-orthodox, who went to funerals where there were thousands of people. the percentage of the virus in that community is very, very high. what can we do? one way is to have the funeral through facebook, where singing and praying can be facilitated through a virtual platform. i also heard from a pastor who was talking about his grandfather who passed away from covid-19. his grandfather was a very, very senior, very respected black pastor. thousands would have come to his funeral, but could not because of the virus. instead, they had five people go into the church and record music. five people somewhere else recorded the sermons. then they put it all together and people from the church drove up and were able to see the whole video they created this way. 3 dr. madison: i want to prevent the deaths. i want us to think about why 70% of covid-19 deaths in places like chicago are black folks. i want the country to take a public health approach, which starts with prevention. in terms of prevention, the reason why we are seeing these rates of morbidity and mortality is because of rationing. the reason we are seeing rationing is because of the lack of planning on the national level, the lack of taking lessons not just previous pandemics and plagues, but also from other countries that have already determined and discovered. for example, cordon sanitaire does not work, so we need to do physical distancing. we need to promote social connections so we can promote sociobehavioral health and well-being. when we do not put ourselves into a situation where we have to ration, we should see fewer deaths, and we should see much less suffering, particularly in vulnerable populations. i think the fundamental problem is that we have gotten into a situation where we have to ration. so why are black and brown folks dying more? is it because of rationing of ventilators? is it because of rationing and not providing an environment where there is equitable access to treatment, equitable access to screening? we have to look at the entire chain of events that happens. it begins with prevention, and making sure we do not have to get into a situation of rationing. rationing is one of the root causes of why we are seeing this demographic differential in morbidity and mortality. when it comes to states determining who is the most worthy, who should be the first in line to have access to screening, treatment, ventilators, it is not our black and brown folks who are already immunocompromised, who are already in high-risk groups from obesity, diabetes, and hypertension. we need to do whatever we can to reduce this pandemic of rationing. we need to promote case finding in all populations. we need to promote contact tracing. we need to promote screening. we need to learn the lessons, not using cordon sanitaire. it reduces trust. it does not promote communication. we need to increase fact-checking and transparency in reporting on who is most infected versus affected. there is so much we could go into related to the cares act and joblessness and the relationship between joblessness and comorbidities, for example. 4 but i saw this one data point that described how for every 1% increase in unemployment, it leads to a 3.5% increase in opioid addiction. 5 the pandemic's economic effects alone will exacerbate our drug and mental health problems down the road. we are developing a lot of psychosocial interventions that deal with the opioid epidemic and how people are responding to this pandemic psychologically, especially when they are unemployed and at home and life looks hopeless. alcohol sales have skyrocketed. 6 people are going to self-soothe, and that is going to cascade to a whole bunch of problems down the road. but that is not what i wanted to react to. what i was wondering, in terms of process and in terms of equity and thinking down the road, is what happens when people feel that there was an unfair distribution of who got saved, who got the ventilator? what could be done now to have more transparency in the icu to support decision-making? there was recently an editorial by daniella lamas in the new york times about the decisions and the criteria for deciding which patients would benefit from getting a ventilator and which would not. 7 ironically, or paradoxically, in end-of-life care, there are always recommendations like, ''do not put an advanced cancer patient on a ventilator anyway. it is futile. you are wasting valuable resources, and it is burdensome, and they are not going to survive.'' so that is not a good use of a very scarce resource. how can those rules about who should live and who is going to be put on a ventilator be made more equitable so to address the concern down the road, so there are not lawsuits saying, ''you discriminated against equally needy patients who would benefit from scarce resources but denied care for other reasons.'' a real quick answer goes back to what dr. elk had said before. your triage committees need guidance documents, and those should be written by ethics committees that are representative of the community. so you should have black ministers involved. you should have every demographic and profession included in your ethics committees to collaborate in creating these guideposts so that it is not left up to an individual, implicitly biased practitioner. dr. elk: and having just one black person is not enough. that is insufficient. dr. nú ñ ez: at least from what i am hearing from other physicians, they are desperate for these equitable protocols. in the absence of protocols, clinicians are having to make the decision in the moment with so many things happening in terms of the trauma, lack of ppe, and so on and so forth. healthcare providers are desperate for these equitable protocols. and i will just remind you that we know data that say, if you have a committee, and 30% of that committee is not representative of the population, you do not have voice. so it is important when we are looking at these committees that it really is that percentage of the committee to bring that voice into the equation. but i will tell you that equitable protocols are desperately sought by healthcare providers who are in the trenches having to make these decisions, and with no time, on top of being under-resourced and potentially unsafe. dr. elk: there is a hashtag on twitter, #pallicovid, used by the palliative care community, linking to all kinds of resources that can help. the reality is, probably only the palliative care physicians or clinicians are looking at it, but others need to as well, because this is the group that has the expertise. now, unfortunately, even though palliative care is the group that has this expertise, they do not and have not been trained in determining cultural aspects of care. that is why a paper on cultural aspects of care, especially at end of life, is so, so key. health equity just published my article and in it we include a table with information about the differences in approach for how to talk to southern black and white patients. 8 and who determined that? the community members, both black and white. everything that is in there is a cultural guide for clinicians. now, this was done in the rural south. i have no idea if it works up north. dr. prigerson and i are going to be collaborating on another study to see to what extent that works up north. but at least, if you respect what the community has asked, then you will go a very long way in showing respect, which, in turn enhances trust. and those additional suggestions of having somebody there with a black person, when they are ill, using facetime so the family can sing and pray with the patient as they are dying. how difficult is that? it is not difficult. it can easily be done. you want to build trust? do that. and by the way, i do not believe that it is a waste of resources, particularly for people whose culture believes god can create a miracle, and if that is what the family wants and believes, then we should respect the patient and/or family's values and act according to their established goals of care. it does not matter if medically it seems like, ''oh, this person will live and this person will die.'' you have to be equitable, as dr. nunez says. the issue of preparedness is of the utmost importance. we definitely need more preparedness for a variety of different issues. for example, i published with co-authors a systematic review, which perhaps is still the only review on communicating risk in epidemics in low-and middle-income countries, and also includes eligible studies on marginalized and at-risk populations here in the united states. 9 some of the things we have been discussing resonate with the findings of the review, which point to the importance of communities and community engagement. as supported by several studies included in the review, when community members and families were involved, communities or patients were also more likely to adopt and embrace mitigation measures. another lesson that we learned from ebola: we cannot go into communities and tell them to suspend traditions for burials and funerals during a time of crisis. we need to think about culturally sensitive rituals to substitute for existing traditions during the preparedness phase. so again, the preparedness process is really key. i'd like to change the topic. in addition to engaging community leaders in finding solutions for issues related to the rationing of scarce resources (for example, the use of ventilators or protective equipment) so that we prioritize vulnerable and underserved populations, especially communities of color, professional associations representing the black and latino communities should also become involved. these associations should consider issuing guidelines that physicians and nurses desperately need to treat and prioritize patients who most need these resources, especially in disparity settings. finally, i had prepared something on paid leave, because among the most promising changes that i see happening-that, again, is not sufficient to meet the actual need-is the family first coronavirus response act, as related to the provision of paid leave for at least some of the workers. 10 i am not an economist, but unfortunately, this provision is really a drop in the sea, because we know that up to 19 million people will be excluded from this provision. 10 on the other hand, people need to stay home as a way of protecting themselves. but we know that a lot of people are excluded from the paid leave provision, and would need to choose between protecting themselves or paying rent and putting food on the table. and this happens primarily within the food service industry and other industries where the people are really on the front line of the epidemic, and/or where workers are from communities of color, or women, or from other vulnerable populations. although the family first coronavirus response act is a step forward, we need to engage communities to make it more of a reality for all americans, because paid sick leave is something that is important not only during this pandemic, but it actually is a human right to be able to take care of one's health and the health of others during times of crisis and beyond. so, it is a step forward, but it is a fraction of what we need. we talked about isolation, opioid use, and issues related to mental health. i think it also bears mentioning that issues of intimate partner violence go hand in hand with alcohol use and gun sales. it is also worth recognizing that both morbidity and mortality, for women, is also likely to explode during this pandemic. many of the places that are being serviced that support victims of intimate partner violence are not-for-profits that receive federal funding, and these are going to be places with incredible need, especially in a time where there is isolation, alcohol, unemployment, et cetera. it bears mention. the most uncertainty in terms of the future of preserved food supply, ways of moving forward to continue living, are all on the backs of populations that are predominantly the ones that have been most discriminated against, or who suffer and bear the burdens in terms of inequities. these are not necessarily the ones who have free access to be able to get on the internet to find information. and even if they do, to other people's points, it is in such a high level of jargon, or written in english language when the individual maybe doesn't speak english. we need much more profound translations of that content to support health literacy as a way to get messages out for everybody, from pastors to communities, because one of the challenges that i see as a physician is that suddenly everybody is interested in science. science is not perceived as being irrelevant anymore. science is not a ridiculous thing. science is not something that people do not need to know about, and suddenly people are wondering, ''what do you mean by immunity?'' i think this is fabulous, but i am not sure that those messages are effectively reaching the communities of need. we need to be able to make those connections and parlay into building trust. currently, there are too many mixed messages. dr. elk: one of the things that you said about community is key. one of the research methods that is very, very appropriate, however extremely difficult to do in a very tight timeline, is community-based participatory research, where you could partner with the community. to reach the communities, we have to work in partnership with them. we can do a community-based research project where we can develop prevention guidelines in words the community will understand and according to the community's values. even if we can only determine feasibility, the goal will be to help save some lives. but if we can determine that this is a method that we can do when the next crisis comes, we will be ready to have such studies. and to add to what dr. schiavo said, i would like to stress, we have to learn from what happened in the ebola epidemic, when whites were attempting to provide aid, they did so without paying respect to the culture. they did not listen to the people experiencing the health crisis. they did not incorporate the culture of the people into it. if you fail to incorporate the culture of the local people, you are doomed to failure, and more people will die. it is a matter of cultural humility that people have to learn, and especially physicians, who unfortunately do not effectively receive this as part of their training. it is part of the nurses' training, but it is not part of the physician's training. dr.nú ñ ez: i agree with you. i think that with the ''do to'' rather than the ''do with,'' mentality, especially with the scarcity of key equipment right now, there is a propensity to say ''let us do something.'' this results in, ''here is the shortcut that lets us something.'' and i think that the best thing to do, even though it may take a bit more time, is actually reaching out and including community networks to create a better outcome in the end if there is a matter of trust. dr. schiavo: actually there is evidence also from the ebola crisis such as for example some interesting case studies on sierra leone and liberia from unicef showcasing that when communities finally got involved, not only in research and intervention design, but also in the implementation and the evaluation of solutions, and in building trust in the community about the recommendations for protection, finally, the ebola epidemic subsided. 11, 12 and i think this is a very important lesson, especially because in the united states, i feel we do not integrate enough community engagement in intervention design, implementation and evaluation. we have imported to a certain extent the community health worker model, but for the most part this model is being implemented in a very limited way because we primarily train people to disseminate information that experts designed. it is not really the same as the kind of community consultative process we need, especially in moments of crisis when we really need to empower communities, giving them ownership of solutions. there is a long list of steps that countries such as taiwan, singapore, and others took that both flattened the curve faster, and reduced the prevalence of disease and mortality. 13 in that long, wonderful list is the item that they addressed the issue of disease stigma and compassion. i do not know where that exists in our state-by-state plans. we do not really have a national plan. but that was listed as a policy in taiwan and it made considerations for those affected by providing food and frequent health checks. it also included encouragement for those under quarantine. and the rapid response included hundreds of action items in their supplement. but just imagine including disease stigma and compassion as a part of the process. dr. elk: andy slavitt is one person who has shown unbelievable compassion and action. he was the head of president obama's medicare and medicaid cms, and helped develop the affordable care act. he is very knowledgeable and very connected. he has taken it upon himself to develop an organization called the united states of care. 14 andy slavitt has put together so many initiatives. for example, he set up a site where ventilators can be shipped from one place to another, even before there were other initiatives. his group also set up a step-by-step guide for bringing resources to underserved communities. 15 (see appendix s1; ª united states of care campaign and reprinted with permission.) so you can take it into your state, and all you need is the governor of that state, for example, to follow this step-by-step guide. now, let us see how many states use this incredible model. in terms of resources, i do not want to plug too much of what we are doing, but we are developing online resources to aid communication between families, between families and medical professionals, particularly in the life-threatening icu situation. but also we are developing tools to prevent people from dying alone and funerals not being able to happen in accordance with and culturally specific cremation and burial practices. we are developing an app that actually is a virtual memorial. we have developed something called the living memory home to help families in that time-it is not going to be a substitute for actually convening and having face-to-face ceremonies at some point, but the idea is, i think people are really struggling with this forced separation and lack of communication as everyone-everyone is essentially a shut-in right now. we are all shut-ins. and when your loved one is dying in the hospital, and you are shut in, regardless of your race or ethnicity, you are upset, you are frustrated, and you need tools to help you communicate better and more effectively. the other point i wanted to make in listening to everyone's' great suggestions, is that all our suggestions are essentially top down. community-based participatory research is great in that a lot of voices are heard. what should recommendations to actual families do? what should be some of the simple patient prompts or family caregivers' checklists for things that they should do to help them protect themselves and ensure their interests? we are always thinking about how we can help other people through being very instrumental and telling them what to do or treating people differently. what can they do themselves to have their rights and interests and values respected? dr. nú ñ ez: i certainly read that in some places patients actually got an ipad that is covered in plastic so that they are not alone, they can connect with some-body and so on and so forth. and if we are talking about best practices, whether it is a phone or any other kind of device, to support that connection when someone is critically ill or at the end of life, that is as instrumental as having an iv. now, granted, i would submit to you that in terms of dying in a hospital, dying alone is a very frequent thing and very culturally devoid thing outside of that hospital. and so perhaps this is a practice we need to bring in that, just like the iv, there is this digital access to music, to a spiritual advisor, to family, to singing, whatever that is, that as a person surrounded by all the illness in a hospital, they do not necessarily feel alone. as long as you attach it to something, it is not like you are mandating that another person necessarily be there, but if an iv is essential, then perhaps we are saying this as well, because we need to pay attention to the humanity of individuals as they go through this struggle. dr. madison: i think that what communities also need to do, particularly my community and black communities and international communities, is to destigmatize accessing mental health services. by destigmatizing access to mental health services, society also has to provide free services, right? so let's promote access to free telehealth, promote access to paid sick time if you are fortunate to have a job, and promote access to free testing and treatment. we should promote destigmatizing access, whether it is for behavioral health or clinical health care. but right now, some of the barriers to access are both inside and outside of the community, so we should somehow support bridging that. in massachusetts, the department of public health, through the massachusetts public health association, highlighted four action items. and i believe that the fourth one is the one we have not mentioned yet, is so important because it adds to an increase in prevalence and incidence of this pandemic, of covid-19 pandemic, and it is to enact a moratorium on evictions, foreclosures and termination of public benefits. what can the individual do about that? not much. if you lost your job and you call up unemployment assistance, you are not even able to get off the waitlist on that phone. people are waiting two, three weeks to get a response in order to get unemployment insurance. i want to also stress that people finding themselves unable to get through to a representative at the unemployment office should document their every try. and so in the process, you are getting someone telling you have to be evicted from your housing, and foreclosures, and losing your public benefits. so it is ecosocial theory. it is all around the lifespan of what is happening to our most vulnerable populations. some of what we can do within our group, within our community is to destigmatize access and promote lobbying and advocacy. but it really is oppression working through ideological, institutional, interpersonal, and internalized mechanisms. dr. elk: one of the things that dr. prigerson had raised was, what about doing something for the patient? there is a tool that was developed at uab in which the palliative care doctors said, ''we will sit with your patient. 15 tell us.''-they have developed a little questionnaire. the patient's loved ones fill in the answers. ''what does he love talking about? what is important to him? what is the name of.?'' this is meant to help the practitioners get to know their loved one, the patient, intimately, and can help to represent the loved one in a very unique, individual way. there is also a tool for providers on how to communicate at this time, developed specifically for covid. all of that is both on twitter under #pallicovid, and also on facebook, which is much easier, and is covid-19 palliative care providers. it is open for anybody. i saw that 3,000 people are already on the facebook group as of the time of this discussion. it has all these tools. if the physicians and others are looking for tools, the palliative care people have the perfect tools. one of them deals with how to communicate and what to say. they use a lot of acronyms to help clinicians remember them. dr. schiavo: i want to highlight something that has not yet emerged from the last discussion, which is the digital divide. we all talk a lot about digital health, we talk about those apps. but these media approaches are not necessarily going to reach the vulnerable populations we need to protect, where word of mouth, community gatherings, churches, and similar channels and venues are still the preferred ways of communicating. we are already seeing that when school went online, some schools in disadvantaged neighborhoods were left scrambling to figure out how to provide online instruction. in addition to this, we are in the middle of an infodemic, and there is a lot of information and misinformation out there. easy and widespread access to social media, which we did not need to care about during h1n1, really have a prominent role in disseminating this misinformation. and although some of the vulnerable populations may not use social media as their preferred media of choice, they hear from other people who have read things on social media. so we need to be aware of these challenges and prepared to equip the public health infrastructure to react to hoaxes and misinformation. i was reading the other day that there were some hoaxes in africa saying that blacks were not susceptible to covid-19. 16 we need to be prepared to counteract misinformation, and the only way to do this is having, again, governments and public health agencies to work with community leaders, so that those leaders become our rock stars on social media and within other information settings. let's give them social media accounts. train them to use social media. let's do something that actually brings their trusted voices to the communities they reach, because whether these communities are on social media or not, they hear from others who are on social media. this is also another important aspect that may have an impact on training of the public health workforce and on the overall infrastructure. dr. nú ñ ez: i want to agree with you. i mean, i will share with you that in terms of our community participatory research project, philadelphia ujima, we brought in the radio celebrities, because the radio celebrities are important from a cultural perspective with lower-income residents in the city. some of these radio celebrities had profound credibility, and whatever they said was viewed as true. unfortunately it is the case that right now there is no way to certify what is actually credible information. dr. prigerson raised the point that we have talked about a top-down approach, and dr. madison eloquently talked about how there is so much in terms of the infrastructure that does not exist, and topdown is important. but i think that some of the bottom-up is, how do we attend to the legitimate disenfranchisement of our at-risk populations, many of whom are saying, ''you do not really care about me. i am expendable. i can clean. i can pick in the fields for your food, but i am not going to have time off, and if i am a casualty of this pandemic, well, then, you do not really care. somehow i am supposed to continue to be engaged, maybe vote, and to be part of this process. how does it make sense when it seems that you all do not really care about me?'' and so i think that there is a component that we have to reach to address that legitimate disenfranchisement as well as figure out through culturally competent sort of communication about how can they have some agency in this, how do they recruit help for when their loved one is sick, identify who were all the individuals that need to be in the loop on that conversation? negotiating the health access process is difficult for most of us, even in better times. how can we streamline the process, provide navigation help during this global pandemic? i think that disenfranchisement linked with health, health literacy, and misinformation, or ''the infodemic,'' is an important part of the storm, and if we do not address that, no matter what happens top down, the disenfranchisement may very well explode. it is important to mention that disenfranchisement is a useful way to control the populace, because if everybody is looking at everybody else, the problem is always going to be that other person. it is us and them. the community affords strength, innovation, and cohesiveness in coming together to find and promote solutions. that being said, we are hearing in the media lots of amazing examples where people are coming together to form community. this is too often drowned out by the sensational stories of hoarding and price gouging. we do not hear the common acts of checking on the elderly neighbor and sort of going grocery shopping. we do not hear about that, because, again, that does not sell eyeball time for the evening news. it is important that we think about how to best use community-focused, inclusion-promoting messages as one of the antidotes to the infodemic. in response to all this, and the infodemic, we are developing some tools. we call them gist, ''giving information simply and transparently,'' so that when oncologists talk with advanced-stage cancer patients, you are disenfranchising patients if you talk about millimeters of tumor growth, or you talk about drugs for which they do not understand the mechanisms of action. we are developing this intervention to both address the infodemic, to simplify and clarify main talking points, and insist that physicians have patients leave a clinic visit doing what in psychology they call cognitive interviewing, ensuring that patients have enough information to make an informed choice-they do not need to know every single fact, but maybe the physicians or the medical community needs to decide what are the main kernels of medical information that, without which, anyone, regardless of race or ethnicity or language or education level, needs to know to make a choice that will resonate with them, that will be consistent with their values, and consistent with informed values. so we are trying to reduce disparities, but through education and information, both on the parts of having physicians communicate to empower patients to have the information they need, to insist on the care that might be consistent with what they would want. it dr. schiavo: i would like to say that pandemics have a way of showing us how much we are interconnected. taking care of everyone in our communities and being our brothers' and sisters' keeper is not only an important human rights issue but also benefits the health of everyone. i hope that this lesson is not going to be forgotten too quickly, as we have seen so many lessons be forgotten in the past. as dr. madison said, we really need to address all the social and political determinants of health so that we can advance health equity and racial equity in the years to come and protect people during this pandemic. in the meantime, i would like to ask for everyone to take the time to thank the people who are on the frontline. yes, the healthcare workers, but also the food and pharmacy cashiers, the sanitation workers, the hospital housekeepers and cleaners, and everyone who puts their life at stake every day, so that so many of us can stay safe. i think it is important to say thank you, because a lot of them are making huge sacrifices for the common good, and we need to do our share and at the minimum to thank them. dr. elk: in terms of prevention, please, work on partnering with communities to develop prevention messaging that is not as complicated as what's on the cdc or other health care sites, but is instead very simple, and not only that, takes cultural differences into consideration. just a photograph or a picture of a native american person or somebody in some tribal dress is absolutely insufficient. a lot of nurses already have training in cultural competency, but sometimes physicians don't have quite as much competency in this area. it is important for all practitioners to show cultural humility and to not talk down to patients, but to ask what their cultural values and preferences are. and then once you know them, respect them. and if you do not know, there are tools and guidelines to improve cultural competency. look at the article that we have just published in health equity. 8 dr. prigerson: one thing that struck me as a way to synthesize what we have been talking about is the huge importance of communication in making sure that families are connected, that health professionals are connected, that people get adequate information, that people's preferences and needs are heard. it all depends on facilitating and improving communication between patients, families, communities, and the medical team. there is hope, but we also know that a lot of work needs to be done to improve not just access to care, but also to strengthen communication, and improve relationships between communities and healthcare institutions, between the federal government and constituents, and between practitioners and patients. communication needs to be facilitated so that people's needs are heard and respected. dr. madison: i have three nieces in the healthcare field. one is a black female physician, chicago. another black nurse in the la area, managing 80 nurses. and the third, black female social worker. they all agreed on their answer to this question, and what they said was, ''let us work towards disease prevention and health promotion instead of a curative model for health care delivery.'' dr. nú ñ ez: one of my favorite acronyms is pdq, which stands for partner-defined quality. if we can start with the pdq straight away, then hopefully we can take advantage of this opportunity for good. there is an asian proverb that says, ''the best part of my house burning down is i have a good view of the moon.'' in crisis, there is opportunity. we are awash with opportunity. the question, as has been mentioned so eloquently by many of you, is, do we then leverage this opportunity for the better in terms of efforts of equity, relationships, communication, infrastructure, to roll it back resulting in a robust, effective prevention model? we will be able to say, ''yeah, this is not just. we've learned from the spanish flu. covid-19 was the tipping point where we changed things up.'' i really, really appreciate all of your time. this was a fabulous conversation. it was just really a wonderful opportunity, and thanks so much for all your insights. ana núñez, md, is a professor of medicine and professor of obstetrics and gynecology, dean of diversity, equity & inclusion at drexel university college of medicine. her expertise includes sex/gender cbr and health and workforce enhancement for underrepresented populations. ''the first step is recognizing, acknowledging, and respecting the inequity, disrespect, and disregard our african american patients have experienced.'' holly g. prigerson is the irving sherwood wright endowed chair of medicine, co-director, cornell center for research on end-of-life care, and professor of sociology in medicine at weill cornell medicine. her research has been continuously funded for over 30 years by the national institutes of health to examine issues of health care disparities at the end-of-life and psychosocial influences on and outcomes of those disparities. renata schiavo, phd, ma, ccl, is a senior lecturer at columbia university mailman school of public health, department of sociomedical sciences, and the founder and board president of health equity initiative, a nonprofit membership organization. she is a passionate advocate for health equity and a committed voice on the importance of addressing and removing barriers that prevent people from leading healthy and productive lives. she has significant experience with and has written on communicating risk and promoting disease mitigation measures in epidemics and emerging disease outbreak settings. dr. maria madison has built her career, since 1983, around evidence-based research methods. this has included conducting and supervising significant public health projects with multicultural communities, often in resource constrained settings. she began her career as a peace corps volunteer in the democratic republic of the congo, (i.e., zaire), and continued working through the private and public sector. dr. madison is currently the associate dean for equity, inclusion and diversity at the heller school for social policy and management at brandeis university. she teaches on subjects such as intersectionality and bioethics. families first coronavirus response act: employee paid leave rights covid-19's impact on the black community: a conversation with health experts and faith leaders 15fee23516de6db106aa9e00b914aad6eb4ce45800c265afe9e9dd387bc 0f4613705ca2ad68439c6131c3ae3b190a6cf8d1 accessed one hundred sixteenth congress of the united states of america mental health in the age of the coronavirus. the new york times online alcohol sales jump 243% during coronavirus pandemic c. death toll tops 1,500 as cuomo warns on ventilators developing and testing the feasibility of a culturally based tele-palliative care consult based on the cultural values and preferences of southern, rural african american and white community members: a program by and for the community communicating risk and promoting disease mitigation measures in epidemics and emerging disease settings what the coronavirus law means for paid sick leave, family leave community care centers, community dialogue and engagement: key ingredients in sierra leone county: communities took the matter in their own hands response to covid-19 in taiwan: big data analytics, new technology, and proactive testing united states of care center for palliative and supportive care. covid-19 resources coronavirus: what misinformation has spread in africa? 2020 supplementary appendix s1 key: cord-031314-z74hhcy3 authors: liu, yang; li, yanmei; luo, wen; liu, shuang; chen, weimin; chen, chun; jiao, shuo; wei, gehong title: soil potassium is correlated with root secondary metabolites and root-associated core bacteria in licorice of different ages date: 2020-09-03 journal: plant soil doi: 10.1007/s11104-020-04692-0 sha: doc_id: 31314 cord_uid: z74hhcy3 aims: licorice (glycyrrhiza uralensis fisch.) is a crucial medicinal herb as it accumulates glycyrrhizin and liquiritin in roots. licorice root-associated bacterial communities shaped by soil characteristics are supposed to regulate the accumulation of root secondary metabolites. methods: the soil characteristics, root secondary metabolites, and root-associated bacterial communities were analyzed in licorice plants of different ages to explore their temporal dynamics and interaction mechanisms. results: temporal variation in soil characteristics and root secondary metabolites was distinct. the alpha-diversity of root-associated bacterial communities decreased with root proximity, and the community composition was clustered in the rhizosphere. different taxa that were core-enriched from the dominant taxa in the bulk soil, rhizosphere soil, and root endosphere displayed varied time–decay relationships. soil total potassium (tk) as a key factor regulated the temporal variation in some individual taxa in the bulk and rhizosphere soils; these taxa were associated with the adjustment of root secondary metabolites across different tk levels. conclusions: licorice specifically selects root-associated core bacteria over the course of plant development, and tk is correlated with root secondary metabolites and individual core-enriched taxa in the bulk and rhizosphere soils, which may have implications for practical licorice cultivation. electronic supplementary material: the online version of this article (10.1007/s11104-020-04692-0) contains supplementary material, which is available to authorized users. licorice (glycyrrhiza) is a genus of herbaceous perennial plants in the family leguminosae, with approximately 20 species known as popular medicinal plants in arid and semi-arid regions worldwide (lewis et al., 2005; xie et al. 2018) . glycyrrhiza uralensis fisch. is the most common species of licorice and its roots contain two major secondary metabolites, glycyrrhizin and liquiritin, which belong to triterpene saponins and flavonoids, respectively (hayashi and sudo 2009) . licorice roots are widely used in the food, beverage, and cosmetics industries (zhang and ye 2009) . the roots are also used in the pharmaceutical industry for antiviral (human immunodeficiency virus [hiv] and severe acute respiratory syndrome [sars] ) and antiulcer medication, and for regulating blood coagulation and thrombosis (cinatl et al. 2003; hosseinzadeh and nassiri-asl 2016) . wild licorice have been exhausted and are gradually being replaced by cultivated licorice, which decreases the quality of licorice . the growth of plants and production of secondary metabolites are intimately related to microbial communities. therefore, the dynamics of the microbiome associated with medicinal plants have been explored extensively (huang et al. 2018; koberl et al. 2013) . there are several studies that have reported the beneficial effects of arbuscular mycorrhizal symbiosis on plant growth and secondary metabolite accumulations in the roots of licorice xie et al. 2018) . other studies have shown that the growth and efficacy of the medicinal herb danshen (salvia miltiorrhiza) can be promoted by beneficial plant-associated microbes, such as those of the pantoea, pseudomonas, and sphingomonas genera (huang et al. 2018) . however, to our knowledge, there is no information available on licorice root-associated bacterial communities and their links with secondary metabolites. the temporal dynamics of soil microbial communities are usually investigated in chronosequences of land restoration in natural conditions (lauber et al. 2013; liu et al. 2019 ) and different developmental stages of crop plants root microbiota . a vital indicator for the dynamics of microbial succession is the temporal turnover of the time-decay relationships, which have been used to describe decreasing community similarities over time (nekola and white 1999) . so far, the time-decay turnover patterns have not yet been investigated in root-associated bacterial communities. additionally, the structural and functional variability in root-associated microbiomes have been studied in some perennial plants, such as ryegrass (lolium perenne), drummond's rockcress (boechera stricta), alpine rockcress (arabis alpina), and fruit (citrus) (chen et al. 2016; dombrowski et al. 2017; wagner et al. 2016; xu et al. 2018) . however, there is currently a lack of research on the temporal dynamics of root-associated bacterial communities in perennial licorice. soil represents the most diverse ecosystem on earth with an exceptionally high microbial diversity (fierer and jackson 2006) . during the growth process, plants select and enrich microorganisms from bulk soil to rootassociated compartments (such as the rhizosphere and endosphere), each of which harbors a distinct microbiome (edwards et al. 2015) . the rhizosphere soil is profoundly influenced by the secretion of plant root exudates, which accordingly results in a 'hotspot' environment (peiffer et al. 2013; schlaeppi et al. 2014) . in contrast, the root endosphere features a highly specific microbiome that is mainly affected by plant genotype (vandenkoornhuyse et al. 2015) . several studies have reported on the root-associated dominant or core bacteria using arabidopsis thaliana as the model plant (bulgarelli et al. 2012; lundberg et al. 2012) . information on the core microbiota is critical for understanding the assembly and stability of root-associated microbial communities. licorice plants of different ages may be accompanied by consecutively and specifically enriched bacterial communities among distinct soil-root compartments. however, the selective core enrichment process of root-associated bacterial communities in licorice has rarely been investigated. although root-associated microbiota have been investigated for a long time, there is still little agreement on how these communities are shaped and what factors regulate their composition (bulgarelli et al. 2012; fan et al. 2018) . the temporal dynamics of microbial communities in natural environments are influenced by multiple factors simultaneously. therefore, it is difficult to determine the relative contributions made by individual factors to the overall microbial succession process . the assembly and composition of the rootassociated microbiome could be influenced by soil conditions such as the ph, nitrogen and phosphorus contents (edwards et al. 2015; xiao et al. 2017) . therefore, it is desirable to obtain a predictive understanding of how root-associated bacterial communities in licorice plants of different ages respond to soil characteristics. in this context, variation in soil characteristics including primary nutrients, soil texture, and micronutrients, is essential for normal growth and secondary metabolite production in plants (fageria et al. 2002) . therefore, understanding how soil variables regulate the individual taxa of the microbial communities associated with the accumulation of root secondary metabolites in licorice is crucial for the optimization of plant-soil interactions for practical licorice cultivation. many studies have analyzed soil microbial communities using illumina paired-end sequencing of 16s rrna and internal transcribed spacer (its) amplicons xiao et al. 2017) . in this study, singleend sequencing was adopted using the ions5™xl platform. this provided longer sequences to read without splicing (mehrotra et al. 2017) , and thus could help to elucidate the root-associated bacterial communities more comprehensively and accurately. the aims of this study were to (1) elucidate the temporal dynamics of root-associated bacterial communities together with variation in soil characteristics and secondary metabolite concentrations in roots; (2) investigate the core-enriched taxa and their time-decay relationships; and (3) provide a comprehensive understanding of the key factor(s) regulating the temporal dynamics of individual taxa related to root secondary metabolites in licorice. the study area is located in the yuzhong north mountains (104°18′-104°19′ e, 36°8′-36°9' n), in lanzhou, gansu province (~150 km from downtown lanzhou) in northeast china. this area has an altitude of 2400-2500 m in the mountains and it is characterized by a temperate semi-arid continental climate. it is known as the cradle and cultivation base of licorice (glycyrrhiza uralensis fisch.) with wide distributions of licorice plants. its average annual and accumulated temperatures are 6.7°c and 2754-3285°c, respectively. the average annual sunshine duration is 2500-2600 h and average annual precipitation is 400 mm. the soil is classified as loessial (calcaric cambisol according to fao classification). the licorice species in the study area were all identified as g. uralensis fisch. the general fertilization regime was conducted with nitrogen (urea: 85 kg ha −1 ), phosphorus (p 2 o 5 : 40 kg ha −1 ), and potassium (kcl: 35 kg ha −1 ). the cultivated sites were subjected to similar fertilization and management practices, with close distance (< 500 m) from the wild site and each other. one-year-old uniform licorice seedlings were transplanted from a nursery into cultivated sites for one to four years until sampling in july 2018 (the transplanting was staggered so that all samples were collected in the same year). licorice seedlings were properly cultivated after transplantation, but the plants that had been cultivated for three years had been excavated ahead of our sampling. therefore, the samples selected from the cultivated sites were referred to as 1y, 2-y, and 4-y (supplementary table s1 ). according to the descriptions of local residents, the wild licorice had been growing for over 10 years. the sampling comprised five plots as biological replicates following a z-shaped pattern in each site, where licorice grew evenly. for each plot, five random soil cores from 0 to 20 cm depth and with a 10 cm diameter were collected and mixed to form a single sample as bulk soil. a group of three to five licorice plants were excavated by digging around the group to keep the roots as intact as possible in each plot. all samples were placed into sterile plastic bags, kept on dry ice, and taken to the laboratory immediately. bulk soils were homogenized by passing the samples through a 2 mm sieve. the soils were then divided into two subsamples. licorice roots were processed to obtain the rhizosphere soil according to a previously described method (xiao et al. 2017) . the scrubbed roots (the root endosphere) were also divided into two subsamples. subsample of the bulk soils and the licorice roots were used for the analysis of soil characteristics and root secondary metabolites, respectively. the remaining (sub)samples were stored at −80°c in preparation for microbial analysis. in total, 60 samples (four sites × three soilroot compartments × five plots) were obtained for further processing. bulk soil characteristics were divided into three groups including primary nutrients, micronutrients, and texture. soil ph was determined using a routine method with a fresh soil to water ratio of 1:5. the soil water content (swc) was measured gravimetrically by drying 5 g fresh soil until the soil reached a constant weight. for the analysis of soil organic matter (som), total carbon (tc), total nitrogen (tn), total phosphorus (tp), and total potassium (tk), the samples were air-dried and sieved (1 mm mesh), and the contents were determined by combustion . the soil texture was tested using a laser particle sizer (ls13320, beckman coulter, usa) with air-dried soil . for the soil available nitrogen (an), phosphorus (ap), and potassium (ak) analyses, the samples were dispersed or extracted, and the contents were determined using an atomic absorption spectrometer . specifically, the tn was quantified following the kjeldahl method and the an was quantified by extraction with 1 mol l −1 kcl, steam distillation, and titration following the alkaline diffusion method. the tp was extracted using 1 n hcl after ignition at 550°c, the ap were extracted using 0.5 mol l −1 nahco 3 (ph = 8.5), and then they were measured following the mo-sb colorimetric method. the tk was digested in a nickel crucible with sodium hydroxide at 750°c, the ak was extracted using 1 mol l −1 ammonium acetate, and then they were measured by using flame photometry. soil micronutrients including copper (cu), iron (fe), and zinc (zn) were analyzed using atomic absorption spectroscopy (fageria et al. 2002) . moreover, three representative root secondary metabolites in licorice were analyzed, namely glycyrrhizin, liquiritin, and isoliquiritin (liquiritin isomer). chromatography-mass spectrometry was performed according to standard procedure (zhang and ye 2009 ) with slight modifications. the detailed method is available in supplementary s1. the total dna was extracted from bulk and rhizosphere soil samples (0.5 g each) using the fast dna®spin kit (mp biochemicals, solon, usa). the total dna was extracted from the root samples (0.5 g each) using a dna secure plant kit (tiangen biotech, beijing, china) following the manufacturer's procedures. the dna concentration and purity were estimated using a nanodrop 1000 spectrophotometer (thermofisher inc., wilmington, germany) and electrophoresis in 1% (w/v) agarose gel (xiao et al. 2017) . the hypervariable v4-v5 region of the 16s rrna gene was amplified using the primers pair 515f (5′-gtg cca gcm gcc gcg gta a-3′) and 907r (5′-ccg tca att cct ttg agt tt-3′) (edwards et al. 2015) . the polymerase chain reaction (pcr) amplifications were performed in triplicate for each sample, and pcr products were mixed in equidensity ratios. then, the mixed pcr products were purified using a genejet™ gel extraction kit (thermo scientific). sequencing libraries were generated using ion plus fragment library kit (48 rxns; thermo scientific). the library quality was assessed using the qubit@ 2.0 fluorometer (thermo scientific). finally, the library was sequenced on an ions5™xl platform (thermofisher inc., massachusetts, usa) and 400 bp single-end reads were generated by novogene (beijing, china). low-quality sequences were sheared using cutadapt (martin 2011 ) and quality-filtered using the qiime pipeline (v1.7.0) (caporaso et al. 2010) . after the removal of chimeric sequences using the usearch tool in the uchime algorithm (edgar et al. 2011) , the remaining sequences were assigned to operational taxonomic units (otus) at similarities of 97% using the uparse pipeline (edgar et al. 2011) . otus lacking more than two sequences were removed. taxonomic information was annotated for a representative sequence of each otu using the rdp classifier at a confidence level of 80% (wang et al. 2007 ) using the silva database release 128. all statistical analyses were conducted in the r environment (v3.6.1; http://www.r-project.org/). most of the results were visualized using the 'ggplot2' package (gómez rubio 2017), unless otherwise indicated. the soil characteristics and root secondary metabolite concentrations were log-transformed before the significance of factors (plant sites) was tested by analysis of variance (anova), followed by comparisons of means using tukey hsd parametric tests ('multcomp' package) (hothorn et al. 2008) . principal component analysis (pca) was used to investigate the distribution of these variables on a scaled parameter matrix and visualized using the 'factominer' package (lê et al. 2008) . the spearman's correlation of these variables was analyzed and visualized using the 'corrplot' package (wei and simko 2013) . alpha-diversity indices were calculated using qiime (v1.7.0) and significant differences were found using kruskal-wallis non-parametric tests along with anova ('agricolae' package) (de mendiburu 2014). nonmetric multidimensional scaling (nmds) was implemented, with significant differences in bacterial community composition tested by three different but complementary non-parametric multivariate statistical analysis methods ('vegan' package) (oksanen et al. 2007 ): permutational multivariate analysis of variance using distance matrices (adonis), analysis of similarities (anosim), and multiple response permutation procedure (mrpp). heatmaps were illustrated based on z-scorenormalized relative abundance of taxa using the 'pheatmap' package (kolde 2015) . a circos plot was created based on the relative abundance of taxa using the 'circlize' package (gu et al. 2014) . boxplots were used to illustrate the variation in alpha-and beta-diversity values. the most common and ubiquitous bacterial taxa across all sites were identified as dominant taxa using the criteria of a recent study (delgado-baquerizo et al. 2018 ) with slight modifications. analysis of the differential taxa was performed using a negative binomial generalized linear model in the 'edger' package (nikolayeva and robinson 2014) . the otu counts from bulk soil were taken as a control, and corresponding p-values were corrected for multiple tests using a false discovery rate (fdr) set at 0.05 (benjamini and hochberg 1995) . core-enriched taxa were selected from overlapping otus in venn diagrams using the 'venndiagram' package (chen and boutros 2011) . ternary plots were visualized to show the distribution of these taxa using the 'ggtern' package (hamilton 2015) . the functions of these taxa were annotated using faprotax (louca et al. 2016 ). time-decay relationships were estimated by fitting a linear model between the changes in community similarity (based on 1 -[bray-curtis dissimilarity]) and the age of licorice plants; the slopes were used to measure the rate of community turnover (nekola and white 1999) . the correlations among the matrices of the three compartment communities, soil characteristics, and secondary metabolites in the roots were examined using the mantel test ('vegan' package). multiple regression on distance matrices (mrm) analysis and the random forest (rf) regression algorithm were used to investigate the effect level of significantly correlated variables on bacterial communities (assessed by bray-curtis distance and beta-nmds1) using the 'ecodist' (goslee and urban 2007) and 'rfpermute' (jiao et al. 2019 ) packages, respectively. linear regression was used to investigate the correlations between log-transformed tk content and the average relative abundance of core-enriched taxa; significant correlations were calculated for each taxon ('corrplot' package). individual taxa were then selected from these significantly correlated taxa again, using the 'masigpro' package (conesa et al. 2006 ). these taxa were visualized using curve plots to illustrate their temporal variability; their correlations with secondary metabolites were calculated using the 'corrplot' package. the anova results showed that the age of licorice plants had significant effects on most variables (p < 0.05). most soil characteristics such as som, tc, tn, and cu, significantly increased with increasing age of cultivated plants; the c/n ratio significantly decreased correspondingly (table 1) . other soil characteristics such as swc, tp, ap, tk, ak, zn, silt, and clay also increased, whereas an, fe, and sand decreased. in addition, the isoliquiritin concentrations in licorice roots steadily decreased with increasing age of cultivated plants. however, the liquiritin and glycyrrhizin concentrations first decreased and then recovered slightly (table 2) . this trend was similar to the temporal variation in soil an, tp, and tk levels. many soil characteristics (swc, tp, ap, tk, ak, fe, and silt) occurred at their lowest levels in the wild site that lacked fertilization and agricultural management. however, all three secondary metabolites had higher concentrations in wild than cultivated licorice. the pca based on scaled soil characteristics and secondary metabolite concentrations showed that the samples were clearly separated according to the age of licorice plants (fig. 1a) . the contributions of variables to principle components were different and their correlations were determined according to the angles among the variables (fig. 1b) , which were further confirmed by the correlation analysis. the concentrations of the three secondary metabolites were strongly positively correlated with each other, but were significantly negatively correlated with most of the soil primary nutrients (tk, tp, ak, swc, ap, som, tc, and tn). among these, only tk was related to all three secondary metabolites. significant correlations were also illustrated between soil characteristics ( supplementary fig. s1 ). in general, soil characteristics and root secondary metabolites had varying degrees of temporal variation and exhibited intimate connections. based on the sequencing of 16s rrna amplicons, 4,464,796 quality reads were obtained (after filtering) from the 60 samples (20 samples per soil-root the most of abundant phyla were oxyphotobacteria (bs: 0.1%; rs: 3.0%; r: 82.6%), proteobacteria (bs: 21.6%; rs: 60.3%; r: 1.2%), actinobacteria (bs: 21.7%; rs: 18.9%; r: 0.1%), acidobacteria (bs: 19.3%; rs: 3.1%; r: 0.01%), bacteroidetes (bs: 6.9%; rs: 8.5%; r: 0.1%), planctomycetes (bs: 8.7%; rs: 1.7%; r: 0.004%), chloroflexi (bs: 6.2%; rs: 1.8%; r: 0.003%), and gemmatimonadetes (bs: 6.9%; rs: 0.7%; r: 0.002%). different soil-root compartments had distinct relative abundance of taxa, which also varied across the licorice sites ( supplementary fig. s2 ). overall, the bulk soil communities were dominated by actinobacteria, acidobacteria, planctomycetes, in particular, oxyphotobacteria accounted for the majority (82.6%) of the root endosphere communities ( fig. 2a) . the alpha diversity of the root-associated bacterial communities was significantly influenced by soil-root compartment and licorice age (supplementary table s2 ). the shannon index and otu richness represents correlations. ph, soil ph; swc, soil water content; som, soil organic matter; tc, total carbon; tn, total nitrogen; an, available nitrogen; c/n, total carbon/nitrogen ratio; tp, total phosphorus; ap, available phosphorus; tk, total potassium; ak, available potassium; cu, copper; fe, iron; zn, zinc; liq, liquiritin; isoliq, isoliquiritin; and acid, glycyrrhizin decreased with root proximity, while they increased in the rhizosphere soil communities with increasing age of licorice plants. similarly, both indices of the bulk soil communities increased from the 1-y to 4-y cultivated licorice (this was not observed for wild licorice). for the root endosphere communities, the indices were not markedly different, apart from the otu richness in the wild site compared with that of the 1-y and 2-y sites, which significantly differed (fig. 2b) . in the nmds plot, different soil-root compartments were clearly separated. the distinct sampling sites were well clustered in the bulk and rhizosphere soils. specifically, rhizosphere soil communities were completely divided into four clusters corresponding to the three ages of the cultivated licorice and the wild licorice (fig. 2c) . the community similarity was ranked as rhizosphere soil < bulk soil < root endosphere (fig. 2d ). the stress values of nmds analysis ranged from 0.028 to 0.111 in the whole bacterial communities and the three compartments, which reflected the accuracy of the method. the nmds results were also confirmed by three multiple statistical approaches (table 3) . for example, compartment and age both had significant effects on the composition of whole communities (p < 0.05). when the whole communities were split into three compartments, the age of licorice plants had greater effects (p < 0.05) on the rhizosphere soil communities (adonis: r 2 = 0.601, anosim: r = 0.842, mrpp: δ = 0.355) than on the bulk soil communities (r 2 = 0.485, r = 0.660, δ = 0.379). however, age had no significant effects on the composition of the root endosphere communities (p > 0.05) with respect to community similarity. taken together, these results revealed distinct temporal successions of the diversity and composition of the root-associated bacterial communities in the three soil-root compartments with increasing age of licorice plants. first, the dominant taxa that were highly abundant and ubiquitous in the licorice plants of different ages were screened. the taxa in the top 20.0% of relative abundance (highly abundant taxa) and occurring in more than half of all soil samples (ubiquitous taxa) were collected. this yielded 360 otus, accounting for 3.2% of all observed taxa. however, on average, these dominant taxa accounted for 65.3% of the sequences. additionally, the dominant communities had close relationships (r = 0.98; p < 0.001; supplementary fig. s3a ) with the remaining communities and exhibited similar distribution patterns with the whole communities (supplementary fig. s3b and table s3) . second, the number of enriched taxa was analyzed in the rhizosphere soil and root endosphere compared with the bulk soil based on the dominant taxa. in total, 104 (1-y), 110 (2-y), 118 (4-y), and 130 (wild) otus were enriched in rhizosphere soil across the different licorice sites. the growing number of enriched taxa revealed an increasing trend with temporal succession. on the contrary, the number of enriched otus displayed a decreasing trend in the root endosphere, with 15, 14, 7, and 7 otus in the 1-y, 2-y, 4-y, and wild sites, separately. interestingly, the number of root endosphere-enriched otus was reduced by half in the 4-y site and then became stable. despite these differences, 62 otus were found to be overlapped and consecutively enriched in the rhizosphere soil across the four ages of licorice. similarly, there were 5 otus enriched consecutively in the root endosphere (fig. 3a) . third, core-enriched otus were selected in the rhizosphere soil (58 otus) and root endosphere (1 otus) from the overlapping of consecutively enriched otus between these two compartments. it was found that more otus were consecutively enriched in the bulk soil when compared with the root endosphere (216 otus) than when compared with the rhizosphere soil (57 otus) across the four licorice ages. thus, the bulk soil had 57 core-enriched otus (fig. 3b) . a substantial number of these otus in the bulk and rhizosphere soils b e l o n g e d t o t h e p h y l a a c i d o b a c t e r i a a n d proteobacteria, respectively (fig. 4a) . the coreenriched otus also had distinct distributions and relative abundances in the three compartments across the four ages of licorice (fig. 4b ). the results from faprotax showed that these core-enriched otus were related to 17 functional pathways (fig. 4c ). in general, most of the otus had chemoheterotrophic features. some core-enriched otus of the bulk soil were related to nitrification and fermentation. in contrast, some core-enriched otus of the rhizosphere soil were related to denitrification, plant pathogen, and aromatic compound degradation. finally, the time-decay relationships of the whole, dominant, and core-enriched communities were elucidated among the three soil-root compartments (fig. 3c) . the whole and dominant bacterial communities had similar time-decay relationships (p < 0.001) in the bulk and rhizosphere soils. the rhizosphere community displayed a stronger rate of decay (slopes = −0.037) than the bulk soil community (slopes = −0.028). however, the core-enriched community of both the bulk and rhizosphere soils displayed decreased turnover slopes at almost the same rate of decay (slopes = −0.026). in the root endosphere, the whole, dominant, and coreenriched communities had no significant time-decay relationships due to the relatively stable community composition. through visualizing of the mantel test, it was found that soil tk, tc, tn, c/n, cu, and clay as well as root isoliquiritin and glycyrrhizin levels, had significant correlations with the core-enriched bacterial communities of the bulk soil. these variables were deemed latent factors affecting these communities. distinct patterns occurred in the rhizosphere soil and root endosphere (fig. 5a) . among the latent factors, soil tk had higher correlations with the core-enriched bacterial communities of the bulk and rhizosphere soils than the other factors. additionally, soil tk consistently displayed a significantly higher explained variance for coreenriched bacterial communities in the two compartments according to the results of mrm (table 4 ) and rf (supplementary table s4 ) analyses, which confirmed the results of the mantel test. therefore, soil tk could be a key factor regulating the temporal dynamics of core-enriched bacterial communities in the bulk and rhizosphere soils. two divergent clusters of individuals from the coreenriched taxa were then characterized: negatively (tk-rs consecutively enriched (62) r consecutively enriched (5) rs consecutively depleted (57 neg) and positively (tk-pos) related to tk in the bulk and rhizosphere soils (fig. 5b) . their characterization was confirmed by the linear regression model ( supplementary fig. s4 ). based on the 'masigpro' analysis, the taxa that were significantly related to soil tk were further selected along with time series. in particular, 11 individual taxa showed significant temporal variation in the bulk and rhizosphere soils with various annotations (supplementary table s5 ). next, the overall temporal variation in these taxa and their significant correlations with secondary metabolites were illustrated ( fig. 5c; supplementary fig. s5 ). in detail, all tk-neg taxa showed consistent variation in bulk soil and displayed positive correlation with some of the secondary metabolites. these taxa all belonged to the phyla acidobacteria and actinobacteria. however, some taxa (including otu 20, 43, and 10,491) showed the same trends with temporal variation in soil tk in the rhizosphere soil regardless of their negative correlations. these taxa were affiliated to the phyla proteobacteria and actinobacteria, which were further annotated as inquilinus, nocardioides, and promicromonospora at the genus level, respectively. these taxa were all positively correlated with root glycyrrhizin and isoliquiritin, and their highest relative abundances were found in the wild site, which exhibited the lowest soil tk content. therefore, all tk-pos taxa displayed their lowest relative abundances in the wild site. in addition, the temporal variation of some tk-pos taxa in the bulk soil (including otu 189, 325, 5144, and 271) opposed the tk variation. some of these taxa showed negative correlations with the three secondary metabolites; they belonged to the phyla acidobacteria and bacteroidetes (in which they were annotated to the class of ignavibacteria). this result was also found in the rhizosphere soil. otu 16 and 13 were negatively correlated with the secondary metabolites. they were annotated to the xanthomonadaceae family and the variovorax genus, respectively, both of which belong to the phylum proteobacteria. collectively, these individual taxa displayed significant temporal variation and habitat adaptation related to soil tk. additionally, they may play different roles in adjusting the accumulation of root secondary metabolites in licorice, which provides clues for later isolation of these individual taxa. specific root exudates have been shown to exhibit high selectivity for the soil microbiome in rhizosphere soil (edwards et al. 2015; huang et al. 2018 ). in the current study, the rhizosphere soil communities were clearly discriminated from the bulk soil communities. this was due to the greater effects of licorice age and habitat filtering on the rhizosphere soil. the research focus was narrowed down to a few hundred dominant taxa in the root-associated bacterial communities, and the coreenriched taxa in different soil-root compartments were investigated. soil tk was defined as a key factor affecting the core-enriched bacterial communities according to multiple but complementary methods. on this basis, we further explored the effects of the key factor on individual taxa associated with the roots of licorice. this approach differed from other studies that have always focused on the community level when investigating the relationships between soil characteristics and microbial communities (chen et al. 2016; fan et al. 2018 ). this analysis facilitated rapid and accurate forecasting of soil characteristics that mediated the links between root secondary metabolites and the individual root-associated taxa (fig. 6) . consequently, we proposed a focused and novel framework for revealing the regulatory effects of soil characteristics on core-enriched and individual bacterial taxa associated with the synthesis of root secondary metabolites in licorice. fig. 5 (a) correlation analysis among soil characteristics, root secondary metabolites, and root-associated core-enriched bacterial communities (bray-curtis distances) in the three soil-root compartments based on the mantel test. the color of the line represents the significance of the differences (p-values). the size of the line represents correlation coefficients (mantel's r). (b) correlation heatmaps between tk and the core-enriched otus in the bulk and rhizosphere soils. the number of significant correlations is indicated in brackets. (c) temporal variation curves of individual taxa with significant correlations and temporal variability in the bulk and rhizosphere soils. ph, soil ph; swc, soil water content; som, soil organic matter; tc, total carbon; tn, total nitrogen; an, available nitrogen; c/n, total carbon/nitrogen ratio; tp, total phosphorus; ap, available phosphorus; tk, total potassium; ak, available potassium; cu, copper; fe, iron; zn, zinc; liq, liquiritin; isoliq, isoliquiritin; and acid, glycyrrhizin. bs, bulk soil; rs, rhizosphere soil; and r, root endosphere effects of soil characteristics on root secondary metabolites normally, the content of nutrients in the soil decreases during perennial growth due to plant nutrient uptake (chen et al. 2016; shakya et al. 2013 ) and removal in the harvested portion of the crop. in contrast, most of the soil characteristics tested in this study significantly increased as the age of licorice plants increased. for example, the increase in som, tn, and tc may be mainly due to the effects of normal irrigation and fertilization every year, but also on account of the accumulation of litters from plant leaf and stem. the swc displayed an increasing trend in the cultivated sites and was negatively correlated with the concentrations of secondary metabolites across all sites. this may be explained by the fact that licorice is resistant to water deficient environment and widely used for ecological restoration due to its drought-tolerant features (li et al. 2011; xie et al. 2018 ). in addition, there is more accumulation of licorice root secondary metabolites under environmental stress conditions (xie et al. 2018 ). the increasing trend in silt and clay contents in the cultivated sites compared with the wild site not only confirmed licorice's role in soil water conservation and improvement, but identified the impacts of the better field management in the cultivated sites. the three secondary metabolites had higher values in the wild site, which was not well managed or fertilized. therefore, licorice plants may be inherently excellent at maintaining higher secondary metabolite concentrations in roots, despite lower levels of swc and other soil primary nutrients. in the present study, soil tk was negatively related to the glycyrrhizin, liquiritin, and isoliquiritin concentrations in the licorice roots, implying its potential roles in the accumulation of secondary metabolites. potassium is also involved in many enzyme activation systems in plants, which promotes the stem strength and improves the stress resistance of plants (wang and wu 2017) . soil potassium is directly related to the production of phytonutrients in oregano (origanum vulgare l.) (jan et al. 2018) . the distributions of soil characteristics and secondary metabolites were divided into four groups corresponding to the composition of bulk soil bacterial communities. this division confirmed that the age of licorice plants had significant effects on some of the soil characteristics and secondary metabolites (as was found from the results of the anova and significance tests). root secondary metabolites can be massively table 4 results of the multiple regression on distance matrices (mrm) analysis of the core-enriched bacterial communities (bray-curtis distances) in the bulk soil (bs) and rhizosphere soil (rs) for each latent factor accumulated in licorice under drought or nutritional stress conditions xie et al. 2018) . this is consistent with the results that the root secondary metabolites were all significantly negatively correlated with some soil primary nutrients in our study. thus, excessive soil nutrients are not necessarily beneficial to the accumulation of root secondary metabolites in licorice. the three secondary metabolites (glycyrrhizin, liquiritin, and isoliquiritin) tested in this study had mutually reinforcing relationships because of their similar metabolic pathways (xie et al. 2018 ). the phylum-level composition of the bacterial communities associated with the licorice roots was similar to that described in previous studies, regardless of plant species (chen et al. 2016; peiffer et al. 2013 ). interestingly, the phylum oxyphotobacteria accounted for 82.6% of the root endosphere communities in the present study. oxyphotobacteria is the product of the evolution of oxygenic photosynthesis in the ancestors of cyanobacteria and it is the most abundant phylum in oceanic picoplankton (bibby et al. 2001) . this result has expanded the distribution range of this phylum and needs to be further clarified. additionally, the fact that some cyanobacteria have photosynthetic nitrogenfixing function is interesting and inner diazotrophic bacteria have been well documented for rice , maize (roesch et al. 2008) , sugarcane (thaweenut et al. 2011 ) and some gramineous energy plants (kirchhof et al. 1997) , but the function of oxyphotobacteria in licorice root should be further identified. however, the root nodules on the licorice in different age groups were not enough to investigate the rhizobia communities, resulting from the effects of licorice growing environment and artificial management. thus, the root nodules and rhizobia were not included in our study. the symbionts were not recovered in the root endophytic population, which might be as consequence of our data processing and rare root nodules during our sampling. however, we would pay further attention to the symbionts in root endophytic communities according to the recent study in the future. the alpha-diversity of the root-associated bacterial communities significantly decreased with increasing root proximity. this result was consistent with other study that has explained ecological niche selection by plants (edwards et al. 2015) . the shannon index and otu richness both increased in the bulk and rhizosphere soils with the increasing age of licorice plants. this trend may be related to the increased soil primary nutrients. in the root endosphere, the shannon index was stable and the otu richness displayed little change among the four licorice sites. this confirmed the stability of root endosphere communities. the composition of the root-associated bacterial communities was well separated according to the three soil-root compartments. additionally, the rhizosphere soil communities were well divided into four clusters compared with those of the bulk soil due to a greater effect of age. this is because licorice root exudates have greater effects on rhizosphere bacteria than bulk soil bacteria; the higher input of rhizodeposits into the rhizosphere may result in substantial changes in the bacterial community (shakya et al. 2013; wagner et al. 2016) . similarly, the composition of the root endosphere communities was stable and no significant differences were observed in their alpha-diversity between the licorice sites. a plausible reason is that these communities, which inhabited the roots of the same licorice species, were less affected by bulk soil characteristics and mainly determined by plant genotype. similar results have also been obtained in the model plant a. thaliana (bulgarelli et al. 2012; hardoim et al. 2015) . the genotypic variation amongst licorice plants needs to be further studied to confirm our inference. enrichment process and time-decay relationships of core-enriched taxa dominant microbial communities play important roles in nutrient cycling in agricultural soils and in microbial colonization of plants (jiao et al. 2019; lundberg et al. 2012) . accordingly, the dominant bacterial communities associated with the roots of licorice were identified representatively in this study. licorice root compartments selectively enriched bacterial communities from the bulk soil and harbored different numbers of enriched taxa across various ages. this enrichment process could be due to the development stages of licorice plants, which was supported by a previous study . with increasing licorice age, the rhizosphere soil enriched more taxa, whereas the root endosphere enriched fewer taxa. the amount and chemical composition of root exudates have been found to change during distinct rice growth stages . thus, it is inferred that the licorice plants selected specific communities over time, enriched a variety of taxa in the rhizosphere soil to prevent environmental interference or pathogenic infection. on the contrary, the root endosphere communities were relatively stable. it is possible that more taxa were enriched at first to adapt to the new environment, whereas some unstable taxa were eliminated during voluntary selection by the plants to recover stable original conditions similar to those in wild licorice. the core-enriched taxa were then defined. this method has been used to select commonly enriched taxa of the same rice species growing in different farmlands . however, only one taxon without annotations was obtained from the root endosphere and the root endosphere communities were always stable as mentioned above. thus, the conserved core-enriched taxa in the bulk and rhizosphere soils were worthy of attention because of precise selections for them. the functional pathways of these core-enriched taxa also had habitat preferences. for example, rhizosphere soil is a relatively anaerobic microenvironment suitable for the metabolism of denitrifying bacteria. additionally, rhizosphere communities are more affected by plant root exudates that can recruit pathogenic microorganisms (dombrowski et al. 2017; huang et al. 2018 ). these habitat characteristics corresponded to the functions of t he ta x a p r e s e n t . t h e s e f u n ct i o n s i n c l u d e chemoheterotrophy, which was found to be the basic lifestyle of most of the bacterial communities in the bulk and rhizosphere soils of the licorice in this study. time-decay relationships in microbial communities are consistent among similar environments (shade et al. 2013) . herein, it was found that the significant turnover slopes of root-associated bacterial communities were much smaller (−0.028 to −0.037) compared with previous studies, which reported the turnover slopes to be between 0 and − 0.3 in air, soil, and freshwater habitats . a possible reason for this wide difference is that licorice selected relatively conserved root-associated bacterial communities. there were no decay patterns in root endosphere communities, which was consistent with their stability. the whole and dominant bacterial communities had steeper turnover slopes in the rhizosphere soil, which indicates a faster rate of community temporal turnover (nekola and white 1999) . in addition, this result indicated that the rhizosphere soil bacterial communities were more vulnerable and underwent rapid elimination and replacement of species due to interactions with different root exudates and soil characteristics (huang et al. 2018; koberl et al. 2013 ). however, the turnover slopes of the coreenriched communities both decreased, because these communities were relatively conserved during licorice development. the links between secondary metabolites and individual taxa mediated by soil potassium the core-enriched bacterial communities in the three soil-root compartments were affected by different latent factors resulting from niche differentiation. many studies have reported that the dynamics of the rhizomicrobiome are affected by different soil characteristics, such as soil ph, nitrogen, and water conditions, to varying degrees (edwards et al. 2015; xiao et al. 2017; xie et al. 2018) . similar relationships are elucidated in another study, indicating that soil characteristics can influence the metabolite content in herbs through different assembly of bacterial communities (huang et al. 2018) . in this study, soil tk was defined as a key factor driving the temporal dynamics of core-enriched bacterial communities in the bulk and rhizosphere soils. some studies have reported that soil potassium is significantly correlated with rhizosphere bacterial communities in wild oat (nuccio et al. 2016 ) and with the relative abundance of proteobacteria in japanese barberry (coats et al. 2014) . some individual taxa were then selected from the core-enriched taxa based on standards of significant correlation with tk and temporal variation in these taxa for better targeting. these individual taxa were sensitive to temporal variation in soil tk and were significantly correlated with the concentrations of different secondary metabolites. this finding demonstrated that soil tk mediates the links between root secondary metabolites and the individual taxa in this study. many studies have reported that acidobacteria is a phylum of oligotrophic bacteria (chen et al. 2016; xu et al. 2018) . therefore, it was likely that these taxa that were negatively correlated with tk had a higher relative abundance due to the lower tk content in the wild site. the positively correlated taxa displayed lower relative abundances in the wild site, which was similar to the result of the rhizosphere soil. these taxa may regulate the accumulation of root secondary metabolites in licorice at lower tk levels as indicated by the distinct correlations between their relative abundances and secondary metabolites. moreover, the class ignavibacteria, which belongs to the phylum bacteroidetes, showed opposing temporal variation to tk. bacteria in this class were negatively related to secondary metabolites in the bulk soil. this is because soil tk is mainly consisted of inorganic potassium, which cannot be used by ignavibacteria. ignavibacteria prefers organic matter, including secondary metabolites, available in the bulk soil. this is supported by a study reporting that ignavibacteria are chemoorganotrophic bacteria (podosokorskaya et al. 2013) . proteobacteria and actinobacteria species are always copiotrophic in bulk soil (edwards et al. 2015) . however, the genus inquilinus of the phylum proteobacteria preferred lower tk in the rhizosphere soil in this study. inquilinus has been isolated from ginseng fields and is able to promote the growth of ginseng (chun hwi et al. 2012; hae-min et al. 2011 ). this may also be true for licorice as inquilinus was positively correlated with the secondary metabolites in the licorice roots. some studies have found that nocardioides and promicromonospora of the actinobacteria phylum have a growth-promoting effect on ginseng and pine tree roots, respectively (chun hwi et al. 2012; kaewkla and franco 2017) . in addition, the inoculation with the plant growth-promoting rhizobacteria improve the tolerance of licorice to salt stress (egamberdieva et al., 2016) . these taxa may therefore have the potential ability to stimulate the licorice resistance to environmental disturbance and the accumulation of root secondary metabolites in licorice, given their positive correlation with glycyrrhizin and isoliquiritin. i n t h e r h i z o s p h e r e s o i l , t h e f a m i l y xanthomonadaceae and the genus variovorax displayed opposing temporal variation to soil tk and were negatively correlated with secondary metabolites in the licorice roots. it has been reported that xanthomonadaceae is enriched during the consecutive monoculture of rehmannia glutinosa, which is detrimental to plant growth (wu et al. 2018) . additionally, variovorax is one of the bacterial genera that displays increased abundance in response to apple replant disease (lucas et al. 2018 ). these two taxa may also be harmful to licorice growth and inhibit the production of secondary metabolites despite of the variovorax paradoxus is commonly described as plant growth promoting rhizobacteria (kudoyarova et al., 2019) . that may be due to the different environmental conditions and plant species. collectively, these individual taxa exhibited habitat-specific features and were associated with the adjustment of secondary metabolite accumulation in the licorice roots under regulation by tk. the interactions of these taxa are very complex and may not be isolated from each other. further research is needed to investigate the vital role of tk in the regulation of root secondary metabolites in licorice under controlled conditions. this study investigated the temporal succession of root-associated bacterial communities and simultaneous variation in soil characteristics and root secondary metabolites in licorice plants of different ages. the core-enriched communities differed among the root-associated bacterial communities, and their time-decay relationships also varied. soil tk was defined as the key factor regulating individual coreenriched taxa. these individual taxa with distinct 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of the chinese herbal medicine gan-cao (licorice) acknowledgments we thank xiaowu yan and ming li for assistance in soil sampling. we also thank the anonymous reviewers for comments on the manuscript. this work was funded by the national natural science foundation of china (no. 41830755 and 41807030).compliance with ethical standards all authors read and approved the final manuscript. the authors declare that they have no conflict of interest. key: cord-028657-q2ghtpd9 authors: grass-boada, darian horacio; pérez-suárez, airel; arco, leticia; bello, rafael; rosete, alejandro title: overlapping community detection using multi-objective approach and rough clustering date: 2020-06-10 journal: rough sets doi: 10.1007/978-3-030-52705-1_31 sha: doc_id: 28657 cord_uid: q2ghtpd9 the detection of overlapping communities in social networks has been successfully applied in several contexts. taking into account the high computational complexity of this problem as well as the drawbacks of single-objective approaches, community detection has been recently addressed as multi-objective optimization evolutionary algorithms (moeas). one of the challenges is to attain a final solution from the set of non-dominated solutions obtained by the moeas. in this paper, an algorithm to build a covering of the network based on the principles of the rough clustering is proposed. the experiments in a synthetic networks showed that our proposal is promising and effective for overlapping community detection in social networks. the analysis of social networks has received a lot of attention due to its wide range of applications in several contexts [1] . specifically, in social network analysis, the community detection problem (cdp) plays an important role [5] . community detection in social networks aims to organize the nodes of the network in groups or communities such that nodes belonging to the same community are densely interconnected but sparsely connected with the remaining nodes in the network [2] . even though most of the community detection algorithms assume that communities are disjoint, according to palla et al. in [6] , most real-world networks have overlapping community structure, that is, a node can belong to more than one community. on the other hand, since the community detection problem has an np-hard nature, most reported approaches use heuristics to search for a set of nodes that optimises an objective function which captures the intuition of community, these single-objective optimization approaches face two main difficulties: a) the optimization of only one function confines the solution to a particular community structure, and b) returning one single partition may not be suitable when the network has many potential structures. to overcome the aforementioned problems, many community detection algorithms model the problem as a multi-objective optimization problem, and specifically, they use multi-objective optimization evolutionary algorithms (moeas) to solve them. once the set of non-dominated solutions is obtained by the moeas, one of the main challenges is to accomplish a final solution. most of the proposed algorithms [5, [7] [8] [9] use the internal criteria (e.g., modularity index [10] ) or the external criteria (e.g., normalized mutual information (nmi) [3] ) to select the final solution. the drawbacks of these approaches are that the internal criteria does not often correspond to the objective function used by moeas and the external criteria uses the ground truth of the network, which it is not always known. also, the selected final solutions obtained by both approaches do not use the knowledge of the overlapping communities (pareto set) obtained by moeas. rough set theory (rst) may be used to evaluate significance of attributes, to deal with inconsistent data, and to describe dependencies among attributes, to mention just some uses in machine learning and data mining [22] . the main advantage of rough set theory in data analysis is that it does not need any preliminary or additional information about data [17] . rst allows to approximate a rough concept by a pair of exact concepts, called the lower and upper approximations. the lower approximation is the set of objects definitely belonging to a vague concept, whereas the upper approximation is the set of objects possibly belonging to the mentioned vague concept [17] . the upper and lower approximations can be used in a broader context such as clustering, denoted as rough clustering [13] . in our proposal, we focus on describing the relationship between the elements of the network (vertices) only taking into consideration their belonging to the communities of the pareto set. then, we use rough clustering to obtain a final covering of the network, that describes the communities with their lower and upper approximations. the lower approximation is the set of vertices belonging to the community without uncertainty, whereas the upper approximation is the set of vertices possibly belonging to this community, therefore located at the boundary of it. hence, the selected final solution uses the knowledge of the overlapping communities (pareto set) obtained by moeas. in this paper, we propose an overlapping community detection algorithm using multi-objective approach and rough clustering, denoted as moocd-rc. our algorithm allows selecting the final solution based on the subjective information as the number of vertices located in the cores or boundaries of the communities. as a consequence, it helps decision-makers (dm) incorporate their domain knowledge into the community detection process. our main contributions are as follows: 1. we define an indiscernibility relationship between vertices of the network by taking the number of communities in the pareto set where they match. 2. we use the rough clustering foundation to build and describe the final covering of the network through the lower and upper approximations of the communities. this paper is arranged as follows. section 2 briefly introduces the necessary notions of multi-objective community detection problem and rough clustering. in sect. 3, we introduce our proposal. section 4 presents the experimental evaluation of our proposal and compared against other related state-of-the-art algorithms over synthetic networks. finally, sect. 5 gives the conclusions and some ideas about future work. this section introduces the necessary background knowledge for understanding the proposed method. first, the definition of multi-objective community detection problem and multi-objective algorithms of the related work are presented. next, we will give the basics about rough set theory and rough clustering. let g = (v, e) be a given network, where v is the set of vertices and e is the set of edges among the vertices. a multi-objective community detection problem aims to search for a partition p * of g such that: where p is a partition of g, ω is the set of feasible partitions, r is the number of objective functions, f i is the ith objective function and min(·) is the minimum value obtained by a partition p taking into account all the objective functions. with the introduction of the multiple objective functions, there is usually no absolute optimal solution, thus, the goal is to find a set of pareto optimal solutions [2] . a commonly used way to solve a multi-objective community detection problem is by using moeas [9] . the first algorithm using moeas for detecting overlapping communities is named multiobjective evolutionary algorithm to solve cdp (mea cdp) [5] . mea cdp uses an undirected representation of the solution and the classical nondominated sorting genetic algorithm ii (nsga-ii) with the reverse operator to search for the solutions optimising the average community fitness, the average community separation and the overlapping degree among communities. on the other hand, the improved multiobjective evolutionary algorithm to solve cdp (imea cdp) [7] uses the same representation and optimization framework of mea cdp but it proposes to employ the pmx crossover operator and the simple mutation operator as evolutionary operators. imea cdps employs the modularity function [10] and a combination of the average community separation and overlapping degree as its objective functions. the overlapping community detection algorithm based on moea (moea-ocd) [9] uses the classical nsga-ii optimization framework and a representation based on adjacents among edges of the network. on the other hand, moea-ocd uses the negative fitness sum and the unfitness sum as objective functions. unlike previously mentioned algorithms, in moea-ocd algorithm, a local expansion strategy is introduced into the initialization process to improve the quality of initial solutions. another algorithm is the maximal clique based on moea (mcmoea) [8] which first detects the set of maximal cliques of the network and then it builds the maximal-clique graph. starting from this transformation, mcmoea uses a representation based on labels and the multiobjective evolutionary algorithm based on decomposition (moea/d) in order to detect the communities optimising the radio cut (rc) and kernel k-means (kkm) objective functions [11] . in [16] the authors combine granular computing and a multi-objective optimization approach for discovering overlapping communities in social networks. this algorithm, denoted as mogr-ov, starts by building a set of seeds that is afterwards processed for building overlapping communities, using three introduced steps, named expansion, improving and merging. most of the exiting works focus on developing moeas to detect overlapping communities but not addresses the problem of selecting a final solution from the set of the obtained non-dominated solutions. the main components in the rough set theory are an information system and an indiscernibility relation [17] . the classical rst was originally proposed using on a particular type of indiscernibility relations called equivalence relations (i.e., those that are symmetric, reflexive and transitive). yao et al. [19] described various generalizations of rough sets by relaxing the assumptions of an underlying equivalence relation. rst takes a pair of precise concepts to study the vagueness of a concept, named the lower and upper approximations. the lower approximation composes of all objects which surely belong to the concept, whereas the upper approximation contains all objects which perhaps belong to the concept. the boundary region of the vague concept is the difference between the upper and the lower approximations [18] . lingras et al. [15] define another generalization of the approximate sets, seeing them as interval sets. the authors propose the rough k-means algorithm, where the concept of k-means is extended by viewing each cluster as an interval or rough set. the core idea is to separate discernible from indiscernible objects and to assign objects to lower a(x) and upper a(x) approximations of a set x. this proposal allows overlaps between clusters [20] . the upper and lower approximation concepts require to follow some of the basic rough set properties such as [14] : 1. an object v can be part of at most one lower approximation. this implies that any two lower approximations do not overlap. 2. an object v that is member of a lower approximation of a set is also part of its upper approximation. this implies that a lower approximation of a set is a subset of its corresponding upper approximation. 3. if an object v is not part of any lower approximation it belongs to two or more upper approximations. this implies that an object cannot only belong to a single boundary region. the way to incorporate rough sets into k-means clustering requires adapting the calculation of the centroids and deciding whether an object is assigned to a lower or upper approximation of a cluster. in the first moment, the centroids of clusters are calculated including the effects of lower as well as upper approximations. next, an object is assigned to the lower approximation of a cluster when the distance (similarity) between the object and the particular cluster center is smaller than the distances to the remaining other cluster centers [14] . the proposed algorithm obtains a final covering through two steps. it starts building sets of indiscernible (similar) objects that form basic granules of knowledge on the network g = (v, e), where v represents the set of nodes and e represents the set of edges which connect nodes. thus, a partition of the set v is obtained allowing us to define an equivalence relation in v . from our point of view, two vertices should be related if they share many communities at the pareto set. next, through the rough clustering foundations, specifically the rough k-means algorithm ideas [15] , we build the final covering of the network by viewing each community as a rough set, which allows us to obtain overlapping communities. in this step, we build a set of granules which represents a partition of v . first of all, we describe a series of useful concepts that we are applying in our proposal. and only if satisfies the following conditions: is defined as follows: where ps is the number of solutions in p s and match(v i , v j ) = mc(vi,vj ) |gv i |·|gv j | . we build the thresholded similarity graph g β = (v, e β ) based on eq. 2 and the user-defined parameter β (β ∈ [0, 1]). let g r = {g r1 , g r2 , . . . , g rq } be the β-connected component set. by definition, the connected component set in a graph constitutes a partition of the set of vertices. we will say that a vertex v i ∈ v is related with a vertex v j ∈ v , denoted as v i r ps v j , if and only if ∃g ri ∈ g r such that v i , v j ∈ g ri , being r ps a equivalence relation. the set built from all the vertices related to a vertex v i forms the so called equivalence class = (v, e) . hence, g ri is a subgraph on g = (v, e) induced from [v i ] r ps . therefore, g r is viewed as granules of indistinguishable elements which do not share vertices. these granules constitutes our initial granularity criterion [21] , and also we will use them to build the final covering of the network. we take the k biggest granules, g ri ∈ g r , according to the number of vertices, as prototypes of clusters and the remaining of them are assigned to those selected ones. therefore, the foundation is to initially covering the network with those granules of indistinguishable vertices that give greater coverage of the network. the variable k, 1 ≤ k ≤ q receives the median value of the number of clusters that form the solutions at the pareto set. for this purpose, we define a similarity function between any two granules g ri , g rj ∈ g r . this function is defined as follows: as described in sect. 2, the use of k-means clustering in rough clustering requires adapting the calculation of the centroids (cluster prototype) and decides whether an object is assigned to a lower or upper approximation of a cluster. in our case, we selected as prototypes of communities the k biggest granules, according to their number of vertices. next, the remaining granules are assigned to those selected ones. a granule g ri is assigned to the lower approximation of a community when the similarity between g ri and the particular prototype of the community g rj , 1 ≤ j ≤ k, is much greater than the similarity to the remaining other prototypes. in this case, the similarity function defined in the eq. 3 is used for deciding whether the remained granules are assigned to a lower or upper approximation of the selected k granules. worth noting that in this step, the assignation process uses the granules obtained in the previous step, g r = {g r1 , g r2 , . . . , g rq }. the selected k biggest granules represent the initial communities of network and also the lower approximations of them. the remaining granules g ri , k < i ≤ q will be part of the lower or upper approximations of the communities according to the similarity s gr and the γ user-defined parameter (γ ∈ [0, 1]). the pseudocode of moocd-rc is shown in algorithm 1. it is important to notice that the used pareto set is the result of using the mogr-ov algorithm [16] . in moocd-rc, initially the cover cv is formed by the k greatest granules in g r , which ones represent the lower approximations of the communities. these k selected granules represent the prototypes of communities to be built. afterly, the remaining granules are included in the lower or upper approximations of the communities in cv according to s gr . worth noting that the lower approximation of those communities are formed by the vertices that definitely belong to them, whereas the upper approximations are formed by the vertices that are located at the boundary of the communities. these vertices represent the overlapping in themselves. in the first step, the building of the equivalence classes is tightly bound to the thresholded similarity graph g β = (v, e β ), which in turn depends on the β user-defined parameter. the higher the value of β the smaller granules will be obtained and vice versa. on the other hand, in the second step the dimensions of the lower and upper approximations of the communities depend on γ user-defined if |t | > 1 then ∀gr i ∈ t take the community cvi associated; add gr j to cvi; else take take the community cvi associate to gr max ; add gr j to cvi and cvi; return cv parameter. in the way of this parameter changes we will obtain boundaries of communities more or less tight. the parameters β and γ allow decision-makers to obtain a final covering of the network by adjusting the cores or boundaries of the communities. in our experiments, we set β = 0.75 and γ = 0.1. we chose these values according to the related works [13, 14, 20] . in this section, we conduct several experiments for evaluating the effectiveness of our proposal. since the built-in communities in benchmark networks are already known, we use the normalized mutual information external evaluation measure to test the performances of different community detection algorithms. hence, the experiments were focused on evaluating the accuracy attained by our proposal in terms of the nmi value. our algorithm was applied to synthetic networks generated from the lancichinetti-fortunato-radicchi (lfr) benchmark dataset [4] . its performances were compared against the one attained by mea cdp [5] , imea cdp [7] , mcmoea [8] and moea-ocd [9] algorithms, described in sect. 2. the algorithms of the related works do not build a final covering from the communities of the pareto set. thus, we choose the best solution in the pareto set, according to the nmi, and compare this solution with respect to the ones obtained by our algorithm. the nmi takes values in [0, 1] and it evaluates a set of communities based on how much these communities resemble a set of communities manually labeled by experts, where 1 means identical results and 0 completely different results. in lfr benchmark networks, both node degrees and community sizes follow the power-law distribution and they are regulated using the parameters τ 1 and τ 2 . besides, the significance of the community structure is controlled by a mixing parameter μ, which denotes the average fraction of edges each vertex has with others from other communities in the network. the smaller the value of μ, the more significant community structure the lfr benchmark network has. the parameter o n is specially defined for controlling the overlapping rate of communities in the network. o n is the number of overlapping nodes, evaluating overlapping density among communities. similar to μ, the higher the value of o n , the more ambiguous the community structure is. in the first part of the experiment, we set the network size to n = 1000, τ 1 = 2, τ 2 = 1, the node degree is in [0, 50] with an average value of 20, whilst the community sizes vary from 10 to 50 elements. using previous parameter values we vary μ from 0.1 to 0.6 with an increment of 0.05. after, we set μ = 0.1 and μ = 0.5, and we vary the percent of overlapping nodes existing in the network (parameter o n of lfr benchmark) from 0.1n to 0.5n with an increment of 0.1; the other parameters remain the same as the first experiment. the average nmi value attained for each algorithm over the lfr benchmark when μ varies from 0.1 to 0.6 with an increment of 0.05, as show in fig. 1 . as the value of μ increases the performance of each algorithm deteriorates, being both moea-ocd and moocd-rc those that performing the best. as the mixing parameter μ exceeds 0.5, the moea-ocd algorithm begins to decline in its performance and it is outperformed by moocd-rc. figure 1 shows the good performance of our method. for summarizing the above results, we evaluated the statistical significance of the nmi values using the friedman test as non-parametric statistic procedure included in the keel software tool. also, we used the holms and finner as post hoc methods. table 1 shows the average ranks obtained by each method in the friedman test. our method ranks second, however, table 2 shows the overall performance of moea-ocd with respect to the remaining algorithms, where fig. 2 . our proposal and moea-ocd have a performance almost stable, independently of the number of overlapping nodes in the network, being moea-ocd the one that performs the best. on the other hand, when the structure of the communities is uncertain, the performance of the moea-ocd algorithm drops off when the overlapping in the network increases, being our proposal the one that performs better, as shown in fig. 3 . similar to the previous experiment, we evaluated the statistical significance of the nmi values. table 3 shows the average ranks obtained by each algorithm in the friedman test. the friedman statistic value distributed according to chisquare with three degrees of freedom is 25.92. besides, the p-value computed by the friedman test is 0.00001. our algorithm ranks second, however, like the previous experiment, table 4 shows the overall performance of moea-ocd with respect to the remaining algorithms, where there is not statistically significance between our proposal and moea-ocd. from the above experimental results, we can conclude that moea-ocd and our proposal have outstanding performances on lfr benchmark networks in most cases. however, our algorithm employs the information contained in the communities of pareto set to build a final covering of the network. although the solutions of pareto set do not have overlapping communities, our proposal does not depend on this for building the final communities. thus, our algorithm can be used by multi-objective evolutionary algorithms which build disjoint or overlapping community structures. it should be noted that our proposal depends on the obtained non-dominated solutions. in these experiments we used the algorithm mogr-ov [16] to generate the pareto set. on the other hand, the settings of β and γ have a narrow relationship over the obtained final covering. following, we will give a brief description about this. in the above experiments, the parameters β and γ are fixed to 0.75 and 0.1, respectively. we will have as results boundaries of communities more or less tight, depending on the way we change those parameters. hence, both of them allow decision-makers to analyze the network according to the domain problem. using the synthetic network generated above with the parameters values μ = 0.1 and o n = 0.1n , we will show the overlapping communities with different lower and upper approximation scales. for that, we change the γ parameter and keep the same β value used in the experiments. the parameter γ allows to tune the boundaries of communities. thus, the higher the value of γ is, the wider the boundaries are and vice versa, which means that there is going to be more or less overlapping vertices, respectively. furthermore, we build two coverings of the obtained synthetic network by considering γ = 0.1 and γ = 0.25. for a better comprehension of the studied network we used the graph analysis tool gephi. it employs both the network properties (e.g., vertex degree) and also the identified communities in the network in the visualization process. figures 4 and 5 showed next were obtained using the force atlas 2 [23] method belonging to gephi. 1 as shown in figs. 4 and 5, the covering obtained using γ = 0.25 shows boundaries of communities wider than the covering obtained with γ = 0.1. thus, the communities showed in fig. 5 have more overlapping vertices than communities showed in fig. 4 . the overlapped vertices are bigger visualized than others and they are placed in the boundaries of communities. as described before, the parameter γ allows the dm from its own knowledge to tight or wide the boundaries of communities. in this way, the decision maker has a mechanism to weigh the importance of lower and upper approximations in the obtained communities. however, the adjustment of β and γ has a direct control over the final covering. worth noting that our algorithm builds the final covering only using the information about the communities of the pareto set. in this paper, we proposed a new algorithm, named moocd-rc, for discovering overlapped communities through a combination of a multi-objective approach and rough clustering. it is composed of two steps: (a) build the granules of the indiscernible objects, and (b) build the final covering of network. in the fist step, moocd-rc defined an equivalence relation between each pair of vertices of the network through the thresholded similarity graph. the obtained equivalence classes under the indiscernibility relation induce a granule set which constitutes our initial granularity criterion. we will also use them to build the final covering of the network. afterward, in the second steps, the algorithm built the resulting communities through the rough clustering, taking the k greatest granules as prototypes of the communities; they also represent the lower approximations inside their own communities. the moocd-rc algorithm was evaluated over synthetic networks in terms of its accuracy and it was compared against four algorithms of the related work. from the above experimental results, we can draw the conclusion that moea-ocd and our algorithm have outstanding performances on lfr benchmark networks in most cases. moreover, this evaluation showed that moocd-rc is promising and effective for overlapping community detection in complex networks. as future work, we would like to make a more automatic adjustment to the β and γ parameters. a survey of tools for community detection and mining in social networks multi-objective community detection in complex networks detecting the overlapping and hierarchical community structure of complex networks benchmark graphs for testing community detection algorithms separated and overlapping community detection in complex networks using multiobjective evolutionary algorithms uncovering the overlapping community structure of complex networks in nature and society an improved multi-objective evolutionary algorithm for simultaneously detecting separated and overlapping communities a maximal clique based multiobjective evolutionary algorithm for overlapping community detection overlapping community detection in complex networks using multi-objective evolutionary algorithm detect overlapping and hierarchical community structure in networks complex network clustering by multiobjective discrete particle swarm optimisation based on decomposition rough-fuzzy collaborative clustering qualitative and quantitative combinations of crisp and rough clustering schemes using dominance relations applying rough set concepts to clustering interval set clustering of web users with rough k-means multiobjective overlapping community detection algorithms using granular computing rough sets: theoretical aspects of reasoning about data rough sets: some extensions generalization of rough sets using modal logic an evolutionary rough partitive clustering granular computing: basic issues and possible solutions a generalized definition of rough approximations based on similarity forceatlas2, a continuous graph layout algorithm for handy network visualization designed for the gephi software key: cord-312603-ear9cyri authors: bakker, craig; halappanavar, mahantesh; visweswara sathanur, arun title: dynamic graphs, community detection, and riemannian geometry date: 2018-03-29 journal: appl netw sci doi: 10.1007/s41109-018-0059-2 sha: doc_id: 312603 cord_uid: ear9cyri a community is a subset of a wider network where the members of that subset are more strongly connected to each other than they are to the rest of the network. in this paper, we consider the problem of identifying and tracking communities in graphs that change over time – dynamic community detection – and present a framework based on riemannian geometry to aid in this task. our framework currently supports several important operations such as interpolating between and averaging over graph snapshots. we compare these riemannian methods with entry-wise linear interpolation and find that the riemannian methods are generally better suited to dynamic community detection. next steps with the riemannian framework include producing a riemannian least-squares regression method for working with noisy data and developing support methods, such as spectral sparsification, to improve the scalability of our current methods. electronic supplementary material: the online version of this article (10.1007/s41109-018-0059-2) contains supplementary material, which is available to authorized users. community detection is an important activity in graph analytics with applications in numerous scientific and technological domains (girvan and newman 2002) . given a graph g = (v , e) with weight function w : e → + , the goal of community detection (or graph clustering) is to partition the vertex set v into an arbitrary number of disjoint subsets of v called communities (or clusters) such that the vertices within a community are tightly connected with each other but sparsely connected with the rest of the graph. clustering on g can be represented as c(g), which is a unique mapping of each vertex to a community. we restrict our work here to undirected, unweighted graphs and to the disjoint partitioning of vertices into communities. for a detailed treatment of this topic, the reader is referred to the work by fortunato (2010) . the relationships between entities in domains such as sociology, finance, cybersecurity and biology are most naturally modeled with the use of graphs. the inherently dynamic nature of such data (fenn et al. 2012) leads to dynamic graph representations. a dynamic graph changes over time through the addition and deletion of vertices and edges. a snapshot of this graph, g n , consists of the vertices and edges that are active at a given time step n. modifications from time n to n + 1 are represented by g n . clustering can be performed at each time step, c(g n ), and as the graph evolves, so do its communities. temporal communities can undergo several different transitions: growth via addition of new vertices, contraction via deletion of vertices, merging of two or more communities, splitting of a community into two or more communities, birth and death of a community, and resurgence or reappearance of a community after a period of time. efficiently detecting these transitions is a challenging problem. the problem of dynamic community detection has received significant interest in the academic literature (cazabet and amblard 2014) . current approaches for dynamic community detection broadly fall under two headings: incremental community detection and global community detection. the approaches in the first category focus on the systematic propagation of communities through time, whereas the approaches in the second category attempt to simultaneously optimize for multiple metrics on several snapshots of data. stability of computation and accuracy of results are the fundamental limitations of the incremental approaches, while memory (space) and computational requirements are the main limitations of the global approaches (cazabet and amblard 2014) . incremental approaches are fundamentally combinatorial in nature (tantipathananandh and berger-wolf 2011; nguyen et al. 2014 ) and involve methods to track communities through time. the stochastic nature of these algorithms makes these methods unstable leading to inaccurate results. mucha et al. (2010) build on the seminal work of lambiotte et al. (2014) for community detection in dynamic multiplex networks by specializing null models in terms of stability under laplacian dynamics. there is a well-developed suite of methods for community detection in static graphs, but it is not always clear how to extend those methods to dynamic graphs in a way that captures the time-varying nature of those graphs' communities. the challenge is to develop methods that vary continuously in time, like the graphs themselves, between snapshots. moreover, if existing methods are extended through time, it will be beneficial to do so in a way that provides new insight or analytical tools as well. with that in mind, we propose a riemannian geometry approach that views dynamic graphs (and thus dynamic communities) through the lens of laplacian dynamics on a matrix manifold. riemannian geometry provides ways of calculating quantities such as distances between laplacians and trajectory speeds on the matrix manifold. as such, it provides a clear and consistent way of representing graph dynamics. this framework is also modular with respect to existing static community detection methods. in this paper, we provide the background theory needed to describe dynamic graphs in terms of laplacian dynamics on matrix manifolds. the primary contribution of this paper is to bring existing theory to bear on a new application area -dynamic community detection. we use riemannian geometry to interpolate between snapshots of dynamic graphs (using geodesics) and to calculate averages of those snapshots; we explicitly show the formulae for performing these calculations. the interpolated and average graphs are then amenable to existing static community detection methods. this allows us to use a consistent approach to track community behaviour both between snapshots, via interpolation, and across snapshots, via averaging. simply transferring previously derived formulae would not allow us to consider disconnected graphs, however, so our contributions also include a way of transforming disconnected graphs so that they are amenable to the matrix manifold tools. using both synthetic and experimental graph data, we experimentally evaluate two different kinds of geodesics. we identify their strengths, as compared with entry-wise linear interpolation, and also discuss their weaknesses. finally, we derive interpolation and extrapolation error bounds for both geodesics (shown in the appendix) and identify promising avenues of future research in this area. our framework enables more accurate prediction of community transitions by building interpolated graphs between snapshots, global community detection through data aggregation, and prediction of future behaviour through extrapolation from given snapshots. we describe the basics of our framework in the "riemannian geometry and dynamic graphs" section, show how it can be applied to dynamic clustering in "a riemannian framework for dynamic community detection" section, and compare the riemannian methods with an entry-wise linear approach on synthetic and real network data in the "computational experiments" section. the novelty of our approach arises primarily from the application of riemannian geometry to dynamic graphs. when combined with existing spectral methods, this also provides a new interpretation of community splitting and merging as bifurcations in a gradient flow dynamical system (see the "dynamic spectral clustering" section). to the best of our knowledge, the riemannian framework presented in this paper is the first of its kind; it is our intent that the research community build from and extend this work to enable features of dynamic community detection not currently considered here. differential geometry deals with mathematics on manifolds; manifolds are spaces that are locally euclidean (i.e., flat), but generally non-euclidean globally (boothby 1986) . a riemannian manifold is a type of manifold that has a metric associated with each point on the manifold. the traditional methods for calculating angles and distances in flat spaces have to be modified on manifolds to account for manifold curvature, and the metric is an integral part of those modifications on riemannian manifolds. a key part of riemannian geometry, for the purposes of this paper, is the geodesic. geodesics are the equivalent of straight lines in curved spaces. a geodesic is (locally) the shortest path between two points. great circles on a sphere are examples of geodesics on a curved manifold. consider a flight from vancouver, canada to london, england: the two cities are at similar latitudes, so on a mercator projection map, the shortest flight would seem to be a straight west-to-east trajectory. in reality, however, flights between the two cities traverse the pole because that is a shorter route -it is the great circle route. the discrepancy is due to the curvature of the earth, which is distorted on a flat map. from another perspective, a geodesic is the path that a particle on a manifold would take if it were not subject to external forcing; a geodesic with constant speed has zero acceleration. riemannian geometry can be applied to matrix manifolds. the grassman and stiefel manifolds are perhaps the most frequently encountered matrix manifolds in differential geometry because they have closed-form solutions for quantities such as geodesics (absil et al. 2007 ). pennec et al. (2006) developed a metric for the manifold of symmetric positive-definite matrices with corresponding expressions for distances, geodesics, and tangent vector inner products in closed form. these formulae are valuable because even when there is a well-defined metric on a manifold, distances and geodesics between points do not usually have closed-form expressions. such quantities have to be solved for numerically. working on this matrix manifold, when appropriate, can be useful: matrix symmetry provides a reduction in effective dimension, and properties such as symmetry and positive-definiteness are automatically preserved. bonnabel and sepulchre (2009) extended this framework to include symmetric positive-semidefinite matrices. the extension essentially worked by decomposing a positive-semidefinite matrix into a nullspace component (a grassman manifold) and a positive-definite component, which could then use the existing metric. researchers have previously used non-euclidean geometries to investigate graphs (krioukov et al. 2009 . that work has then been applied to large-scale networks such as the internet (boguná et al. 2010) . the approach described in this paper differs in a subtle but meaningful way. in those papers, the mappings used treat graph nodes as points in a hyperbolic space. our present work, however, treats the entire graph as a single point in a non-euclidean space. the work of bonnabel and sepulchre (2009) combined with that of pennec et al. (2006) enables us to consider graph laplacians as points on a manifold of positive-semidefinite matrices. each graph is a point, and thus a time-indexed sequence of graphs forms a trajectory on the manifold. this, in turn, means that we can calculate quantities such as trajectory velocities, distances between graphs (represented by manifold distances between their respective points), and relevant geodesics. given that we are interested in dynamic community detection, the laplacian is a natural object to work with. the laplacian uniquely defines a graph (up to self-loops), and there is already a known connection between the laplacian spectrum and community structure (newman 2010) . previous work in dynamic community detection (e.g., mucha et al. (2010) ) has also worked with the laplacian. graph laplacians have a certain structure that make them amenable to the riemannian geometry techniques presented here as well: laplacians are symmetric (for undirected graphs) and positive-semidefinite. adjacency matrices, for example, are generally indefinite and thus would not be suitable for use with the matrix manifolds described here. we chose to work with the combinatorial laplacian, l = d−a, because it has a constant nullspace for connected graphs (newman 2010) . this constant nullspace makes the geometric calculations much simpler than they would be otherwise. it is possible to use other laplacians, such as the normalized laplacian. if these laplacians do not have constant nullspaces, though, the interpolation involves extra calculations (detailed by bonnabel and sepulchre (2009) ). assuming no self-loops, the combinatorial laplacian also has the virtue of being easy to convert into an adjacency matrix. that being said, as long as a laplacian is symmetric positive-semidefinite and has a constant nullspace dimension (for connected graphs), it is possible to calculate geodesic interpolations for that laplacian. there are two other relevant considerations we wish to address here. firstly, the laplacians of unweighted graphs constitute a discrete (and therefore sparse) subset of the matrix manifold. as such, any continuous trajectory will contain weighted graphs. secondly, directed graphs do not have symmetric laplacians, and thus they cannot be considered within this framework without symmetrizing them somehow (e.g., by ignoring the directionality of edges). for the purpose of community detection, though, edge direction may not be important. there are two primary components to our framework. the first involves modelling and analyzing the dynamic behaviour of the graph prior to any community detection. for this, we show how to calculate an average graph from a collection of snapshots (for use in a time-averaged community detection) and how to interpolate between time-indexed graph snapshots (for seeing how the graph evolves over time). in the appendix, we derive and analyze bounds on the interpolation error in terms of distance on the manifold. the second component consists of applying community detection methods to the dynamic graph. in this paper, we will focus on spectral methods, because they have convenient properties under continuous laplacian dynamics, and the louvain method (blondel et al. 2008) , because of its computational speed and ability to handle disconnected graphs. however, the riemannian geometry methods do not require using any one particular community detection method. we begin with interpolation between two snapshots. it is possible to do this using an entry-wise linear approach, l(t) = (1 − t) l a + tl b , but there are good reasons not to use this approach. firstly, the laplacians for a given dynamic graph all exist on a matrix manifold. for the trajectory l(t) on that manifold, though, the trajectory speed is not constant, the trajectory direction is not constant, and it is not the shortest path from l a to l b . it is precisely analogous to the mercator projection map example given earlier -moving at a constant velocity (i.e., constant speed and direction) on the map would not correspond to moving at a constant velocity on the earth because of the earth's curvature. experimentally, we have observed that the linear interpolation begins and ends its trajectory moving very quickly while the bulk of its trajectory moves relatively slowly. the difference between maximum and minimum velocities can be orders of magnitude, depending on the size of the graph and the distance between the two graphs being interpolated. secondly, in connected graphs, the product of the laplacian's non-zero eigenvalues (i.e., the determinant of the positive-definite component) is concave along the linearly interpolated trajectory. if the two points are far enough apart, this product will go through a maximum between the two points. this maximum can, again, be orders of magnitude greater than the product at either endpoint; like the trajectory velocity, this variation will depend on the size of the graphs in question and their distance apart. the geodesic interpolation, however, provides a linear variation in the product of the eigenvalues. pennec et al. (2006) comment on this in more detail. for a graph, this product relates directly, by kirchoff 's matrix tree theorem, to the number of spanning trees in the graph (harris et al. 2008) . in other words, the linear interpolation increases the overall connectivity of the graph between snapshots. finally, the linear interpolation cannot always be used for extrapolation. all of the interpolated laplacians are positive-semidefinite, but it is easy to provide examples where the extrapolation quickly becomes indefinite. instead, we propose using geodesic interpolation. a geodesic interpolation trajectory has a constant velocity, produces an eigenvalue product that varies linearly between endpoints that are connected graphs, and can be extrapolated indefinitely without leaving the manifold of positive-semidefinite manifolds (with constant nullspace dimension). following bonnabel and sepulchre (2009) , we show how to calculate this geodesic between two snapshots of a given dynamic graph. consider the laplacian l at a point. it can be represented with its eigendecomposition: where the columns of α span the range of l. moreover, the nullspace, ξ , is always parallel to (1, 1, . . . , 1), and thus span(α) is constant even though α may not be, in general. consider the geodesic between l a and l b . we can calculate the svd of α t b α a : the diagonal matrix σ ab has the principal angles between the subspaces spanned by α a and α b as its diagonal entries. since those subspaces are the same, σ ab = i for any two laplacians. we then calculate , and u is constant for all points on the geodesic; α and o are not constant, though. furthermore, we can use the same u matrix for any laplacian of a given dynamic graph without affecting our calculations, because the span of u is constant. we calculate r = u t lu for l a and l b . the geodesic from l a at t = 0 to l b at t = 1 is then if there are multiple time-sequenced snapshots, this method can be used to do a piecewise geodesic interpolation with t being shifted and scaled appropriately. note that the constant laplacian nullspace means that we can work solely with the r components of l and ignore the grassman component. we can also extrapolate with this geodesic simply by continuing the trajectory for t > 1. if we are interested in the average behaviour of a dynamic graph, we can calculate the least-squared-distance mean (the karcher mean) of a set of graph snapshots. to do this, we use the r matrices derived from the graph laplacians as before; each graph i has a matrix r i associated with it, and we want to determine the 'average' matrix s for n snapshots. we then list the sum-of-squared-distance function, the distance function itself, and the gradient of the squared distance (pennec et al. 2006) , respectively: we use iterated gradient descent to calculate the mean: according to pennec et al. (2006) , this usually converges quickly. riemannian geometry centers around the riemannian metric -changing the metric entails changing properties of the manifold (such distances and geodesics). the current metric can be described as affine-invariant (pennec et al. 2006 ), but it is not the only metric that could be used for the space of positive-definite matrices. we could also use a log-euclidean metric as described by arsigny et al. (2007) . the primary reason to consider using the log-euclidean metric instead of the affine-invariant one is computational cost: the formulae for distances and geodesics are simpler and easier to calculate for the log-euclidean metric. those distance and geodesic formulae are, respectively, another computationally beneficial feature of the log-euclidean metric is the closedform expression that it has for calculating the mean of a set of matrices: to utilize these formulae for interpolating between graphs, we would simply replace eq. 6 with eqs. 9, 3 with eq. 10, and the iterated process in eq. 8 with a single evaluation of eq. 11. there are other expressions that are simpler to evaluate for the affine-invariant metric, but those quantities may not be needed, and the different invariance properties of each metric may be valuable in different circumstances. on a practical level, the two metrics generally produce similar interpolations (arsigny et al. 2007) : the spectrum of the affine-invariant interpolations tends to be slightly more isotropic than that produces by the log-euclidean interpolations, but both interpolate determinants linearly between interpolation points (see the "graph interpolation and averaging" section). for the rest of this paper, we will distinguish the geodesics and means calculated with the two methods as being either affine-invariant (ai) geodesics or log-euclidean (le). the methods described in this paper currently assume that the graph in question is connected and remains so at all points of interest. as they stand, they could potentially handle a graph with a constant number of disconnected components (which would correspond to the laplacian nullspace having a constant dimension), but this does not significantly improve the method's generality. in order to be widely applicable, the interpolation methods need to be able to handle changing connectivity. we can accommodate this by using a bias term with, potentially, a thresholding procedure. for a given adjacency matrix a, we add to each off-diagonal entry a bias term /n, where 1 and n is the number of vertices in the graph, to produce a biased adjacency matrixã (which is now connected). we then construct a biased laplacian matrix from a, perform the interpolation on the biased laplacian and subtract /n from each offdiagonal entry of the adjacency matrices produced by the biased interpolation. if need be, we can then apply a threshold to the resulting adjacency matrices or round those matrices to an appropriate number of decimal places. this approach essentially replaces the laplacian's λ = 0 eigenvalues with λ = . empirically, we found that this approach did not significantly change the interpolated trajectories for connected graphs while also producing reasonable results for disconnected graphs. if we consider the properties of the riemannian metrics discussed in this paper, we can see why adding this small bias would not significantly disturb a geodesic trajectory. with these metrics, matrices with zero or infinite eigenvalues essentially exist at infinity. for matrices with finite eigenvalues greater than zero, the distances between matrices are relative and directly tied to the matrices' spectra. for example, the distance from λ = 10 −6 to λ = 10 −5 is comparable to the distance from λ = 1 to λ = 10. this means that a geodesic, which is a minimum-distance path between points, will not significantly alter the part of the spectrum associated with λ = values unless it is absolutely necessary to do so in order to reach the destination. moreover, adding a fully connected graph with edge weights of would not meaningfully change the community structure because of the separation of scales (presuming a very small value of ). in our computational experiments, we found that = 10 −6 provided a good balance between avoiding ill-conditioning and keeping small, but even increasing to 10 −3 did not change the interpolation significantly. as we increased , though, we found that the geodesic interpolations approached the trajectory of the linear interpolation; at, say, = 10 6 , they were almost identical. this, too, makes sense: as the eigenvalues become uniformly larger, the manifold becomes flatter, and the differences between the data points become smaller. the flatter the manifold, the closer the geodesic is to the linear interpolation. however, the geodesic interpolation is still guaranteed to remain positive definite, and the linear interpolation is not. this suggests that if the linear interpolation were more desirable in a particular application but the application also called for the use of extrapolation, then using a geodesic with a large bias term could provide the desired capabilities. it is possible to use spectral clustering with the first non-trivial eigenvector for community detection, but this method can be improved upon by using multiple eigenvectors (boccaletti et al. 2006 ). this approach is convenient for continuous laplacian dynamics because as long as the eigenvalues are distinct, we can expect the eigenvectors and eigenvalues to vary smoothly with smooth changes in l. if the eigenvalues of the eigenvectors in question are not distinct, then the eigenvectors are not uniquely defined, and if eigenvalues whose eigenvectors are being used for spectral clustering cross during the course of a trajectory, the spectral clustering may experience a discontinuous jump. disconnected graphs can provide exactly this kind of behaviour (e.g., with multiple zero eigenvalues). moreover, if the number of disconnected components is not constant, then it will not suffice simply to consider the first m non-zero eigenvalues, for the set of such eigenvalues will not be constant. assume that the graphs are connected, that there is an ordering of the eigenvalues of l such that λ i ≤ λ i+1 , λ 1 = 0, and that eigenvector ξ (i) is associated with λ i . we can then plot each of the graph nodes in n , where node k has coordinates given by n+1) , and use clustering techniques to identify communities. one way of identifying and tracking communities is through defining a kernel for the nodes. summing over all of the nodes then produces a density function. the maxima of that density function correspond to cluster centroids, and the separatrices between maxima define community boundaries in the (reduced) eigenspace. with a symmetric gaussian kernel, this density function would be . other kernels could be used, but this provides an easily differentiable density function, and the magnitude of the kernel is not very important -what matters is the relative changes in density, not the function's absolute value. see an example of this in the spectral plot shown in fig. 1 . the format of fig. 1 is used for all other spectral plots in this paper. changes in the graph's communities can then be seen as changes in the density function. the density of a cluster is proportionate to the magnitude of the density function at the peak (i.e., the cluster centroid). community growth and contraction can be seen by points traversing community boundaries (i.e., separatrices). birth and death correspond to the emergence or disappearance of a peak in the density function. merging and splitting correspond to the merging and splitting, respectively, of the density function peaks. this splitting and merging correspond very closely to pitchfork bifurcations fig. 1 2-d spectral plot of graph nodes. the graph nodes are plotted as points, the contours show the magnitude of the density function, and the horizontal and vertical axes correspond to the ξ (2) and ξ (3) components, respectively. this particular plot shows two distinct communities with one node at approximately (-0.09,-0.11) that does not belong very strongly to either community and a cluster of points around (-0.07,0.05) that seems close to forming its own community in dynamical systems; more precisely, the pitchfork bifurcation happens to the gradient flowẋ = ∇f . birth and death also correspond to pitchfork bifurcations, but this is not as immediately obvious. it is a corollary of the poincaré-hopf theorem: creating a new maximum results in the creation of additional saddle points and/or minima (domokos et al. 2012) . to identify death, merging, or splitting, we can track the hessian of f. if it becomes singular at a point, that is an indication of a potential bifurcation there. birth may be identified in the same way, but searching the space for such a phenomenon may be more difficult than simply tracking known maxima and monitoring the hessian at those points. once the spectrum has been plotted, techniques such as k-means clustering can identify communities. this should produce a sufficient approximation of the separatrices between maxima. however, if two eigenvectors are used, it may even be easier to identify communities visually. to demonstrate our methods, we initially created a series of graph snapshots using a synthetic graph process. the dataset was created by generating two erdős-rényi (er) random graphs with 100 nodes each, as representing distinct communities, with edge probabilities of p e = 0.15 for both. we then began connecting the nodes belonging to the two communities through an inter-community edge probability of p int p e ; we increased p int all the way to p e to simulate the distinct communities merging. once the merger was complete, we gradually decreased p int to simulate the splitting of a large community into smaller ones. to test our methods on real-world data, we used proteomics data produced by mitchell et al. (2013) . networks were produced by identifying subnetworks of upregulated proteins (p < 0.05 and fold change > 1.5 compared to uninfected mocks) from the overall human protein-protein interaction network (keshava prasad et al. 2008) . the network data indicates time-varying linkages between different proteins in human lung epithelial cells that have been infected by the severe acute respiratory syndrome corona virus (sars-cov). the proteomics network formed a relatively sparse, highly disconnected graph of 576 nodes, and we used the data snapshots at t = 24, 30, 36, 48, 54, 60, and 72, where t is the number of post-infection hours. because this graph is disconnected (and severely so), we use the bias approach described in the "disconnected graphs" section. we implemented our methods in python, making particular use of the matrix exponential and logarithm functions in the scipy package. to evaluate the interpolation and averaging results for the synthetic network, we recorded connectivity measurements, spectral snapshots from interpolated and averaged laplacians, and the total number of communities in the interpolated and averaged laplacians. to measure connectivity, we used the logarithm (for scaling purposes) of the product of the non-zero laplacian eigenvalues as mentioned in the "graph interpolation and averaging" section. for the spectral snapshots, we used the eigenvectors corresponding to the first two non-trivial eigenvalue to produce plots as described in the "dynamic spectral clustering" section. these snapshots provided an evaluation that was more qualitative than quantitative. we then used the louvain method to perform community detection. the graph snapshots are provided in additional file 1, and the code implementing the methods is provided in additional file 2. the spectral snapshots and connectivity measurements were not as useful for the proteomics network because the proteomics network was highly disconnected, but the louvain method was still applicable for community detection. to investigate the interpolation and averaging of community structure for this network, we tracked the total number of communities, the total number of communities with at least five members, community similarity, and graph energy. because the network was highly disconnected, the louvain method produced many small or single-member communities. tracking the number of communities above a certain size helped to reduce the amount of noise due to that effect. by community similarity, we mean not just the number of communities but the composition of those communities as well. it can be difficult to measure the degree of similarity between two graphs' community structures when there are many communities and the community labelling is not consistent, but we can look at the pairwise similarity with the rand index (rand 1971) . the rand index works by using a baseline or ground truth case, considering every distinct pair of nodes, and determining whether or not they are in the same community. it then looks at these same pairs in another graph of interest. if, for a given pair of nodes, the nodes are either in the same community as each other in both graphs or not in the same community as each other in both graphs, that pair gets a score of 1; otherwise they get a score of 0, indicating a dissimilarity between the community structures of the two graphs. summing the results over all pairs and dividing by the number of pairs yields a score between 0 and 1, where 1 indicates that the two graph's community structures are identical. the smaller the value, the less similar the structures are. given that we had no ground truth between the data snapshots, we instead looked at the changes in this metric from one snapshot to the next. ideally, there would be a steady change in this value between points -a sawtooth pattern over the course of the whole interpolation -as we measured how the interpolation differed from the most recent data snapshot. finally, to measure network connectivity, we used graph energy instead of a laplacian eigenvalue product. the energy of a graph, e, is defined as the sum of the absolute values of the eigenvalues of the adjacency matrix. given that it is bounded by the number of edges, m, in an unweighted graph (brualdi 2006), we can also use it to bound the number of edges: and thus it gives us information about both graph spectra and graph connectivity. for both sets of data, we used thresholding on the edge weights to get unweighted graph equivalents. this procedure, and especially the threshold value used, was more impactful on the proteomics data than on the synthetic data. the graph spectral snapshots are shown in fig. 2 , and we can clearly see the expected merger and separation of two communities there. we can now interpolate from the third to the fourth data snapshot and then from fourth to the fifth data snapshot to further investigate this community merger and separation. snapshots from the ai geodesic interpolation are shown in fig. 3 ; the results from the linear and le geodesic interpolations fig. 2 synthetic graph spectral plots, frames 1-7. the spectral plots of the synthetic data snapshots are presented in order from left to right, and top to bottom. they show two communities that are stable and separate except for the merger shown in the fourth frame. there are also nodes that do not associate closely with any community at various points in time were almost identical with these. increasing the temporal resolution would become increasingly cumbersome for presentation in a printed format. however, the method does lend itself well to video presentations of the dynamic community behaviour (see additional file 3 for an example). synthetic graph interpolation. the interpolation's frames are presented from left to right, and top to bottom. at the top left, the first frame is the third data snapshot, the sixth frame is the fourth data snapshot, and the eleventh frame is the fifth data snapshot; the interpolated frames are taken at evenly spaced time intervals between the data snapshots. the interpolated frames show a clear progression of community merging and splitting as well as some outliers that do not seem strongly attached to any community in fig. 4 , we can see how the graph connectivity changes over time. the geodesic curves both interpolate the eigenvalue product linearly between points, whereas the linear interpolation is slightly concave. for this dynamic graph, the data points are relatively close to each other, and thus the geodesic and linear interpolations are very similar. if we interpolate between t = 0, t = 3, and t = 6, we can see the distinction more clearly, as in fig. 5 . thresholding gives us a piecewise constant graph. the graph dynamics consist of an edge addition phase followed by an edge subtraction phase, so the thresholding parameter simply determines when that entry flips from 0 to 1 (or vice versa). if we were to use a finer time resolution, we might see a slight difference between the linear and geodesic interpolations with respect to when this transition happens, but the basic behaviour would remain the same. in performing community detection, we found that the geodesic interpolations produced adjacency matrices with negative entries. almost all of these entries were on the order of 0.001 to 0.01, and none were larger than 0.1. negative edges need not be a barrier for community detection (e.g., see traag and bruggeman (2009) ), but they can cause problems for the louvain method, so in doing community detection, we simply set these entries to 0. this was only necessary for community detection on graphs that did not use thresholding. when using a threshold, any value equal to or below the threshold, including a negative value, was set to 0. the spectral plots showed two communities merging and splitting with some outliers along the way. we found that the louvain method split the merged community into four, and the outliers sometimes formed very small communities of their own (fig. 6) . the difference in results between the two methods suggests that in community detection, it may be worthwhile to be able to assign an 'unaffiliated' status to some nodes -nodes that are not really part of any community. this kind of behaviour is what gives us, for example, the brief existence of a small community (of size 3) in the le geodesic interpolation between logarithm of product of non-zero eigenvalues over time with longer interpolation window (no threshold), synthetic graphs. interpolating between graphs that are 'farther apart' leads to a more apparent distinction between the geodesic and linear interpolations. the ai and le geodesic are still indistinguishable with regards to the connectivity measure, however t = 1 and t = 2. when we use a threshold, these behaviours cease, as we now have a graph that is piecewise constant in time for all three interpolations. finally, we consider the average behaviour of this graph using the mean graphs produced by each interpolation method. the spectral plots of these graphs are shown in fig. 7 , and they clearly show two distinct communities. this indicates that the merging of the two communities was only a transient effect and that the same communities reemerged after the temporary merger. the averaging process preseved the structure that we designed the dynamic graph to have. if the second pair of communities were significantly different from the first, then the spectrum of the average graph would not display two distinct communities so clearly. table 1 illustrates the similarities while highlighting the small differences between the results: the geodesic interpolations consistently have slightly higher modularity and slightly lower connectivity than the linear interpolations, but thresholding the resulting graphs reduces those differences. this is not surprising given both the propensity that linear interpolations have for increasing connectivity and the similarity of the geodesic and linear interpolations in this case. in interpolating the proteomics network data, we again obtained negative adjacency matrix entries (around 5% of the total entries). the ai geodesics produced far fewer such entries than the le geodesics (by an order of magnitude), and the ai entries were usually smaller. of the negative entries, the largest was -0.16, but less than 1% of the negative entries had magnitudes greater than 0.01. as with the synthetic graphs, we simply set these negative entries to 0 when using the louvain method. figure 8 shows how the number of graph communities varied over time and how different thresholding levels affected those results. with no thresholding, we found that fig. 6 communities in interpolated synthetic graphs. when no threshold is applied (top), the louvain method produces varying numbers of communities during the merger of the two original communities, and even the data snapshot of the merged communities shows not one but four communities; we also see some differences between the two geodesic interpolations. with a threshold (bottom), though, the piece-wise constant nature of the interpolation shows forth the results were too connected (i.e., not enough communities) for all three interpolation methods: after leaving a supplied data point, the number of interpolated communities would immediately drop, remain relatively constant, and shoot up upon reaching the next data point. thresholding produced better results. generally speaking, the ai geodesic produced too many communities while the linear interpolation produced too few, and neither produced a steady deformation from one data point to the next. the le geodesic showed an intermediate behaviour in this regard, and a threshold of 0.02 produced best performance. the number of communities produced by the interpolation did not vary smoothly, but there was a general progression from data point to data point. changing the threshold value had a small effect on the ai geodesic, but it did nothing to improve the linear interpolation, and using a threshold value of 0.5 actually produced an odd spike in the number of communities halfway between data points. we will return to this phenomenon later. in looking at fig. 8 , though, we see that there are many communities relative to the size of the graph -most of these are communities of one or two nodes that are not connected to the rest of the graph. if we only consider communities of a certain size, we can get a more accurate picture of the true community dynamics. in fig. 9 , we look only at communities that contain at least five nodes and consider how the results are affected by different threshold values. when using a threshold value, the results are somewhat similar to those in fig. 8. in fig. 8 , there were too few communities because the graph was more connected, and we observe the effects of that increased connectivity here, too: there are fewer communities overall, but the communities that are present tend to be larger, and there are more large communities. the geodesic interpolations, on the other hand, were less connected. therefore, they had had many small communities and relatively few larger ones; the best results came from the le geodesic with a small threshold. the case without thresholds was more interesting. there, the linear interpolation still often produced too many communities, but the geodesic results did not uniformly produce too few communities. the le geodesic may have been slightly better than the ai geodesic, but they were both still producing results that looked much more reasonable than they had when we plotted the total number of communities. in fact, those results look even more regular and smooth than the thresholded results. with some analysis, we can see why using a threshold value of 0.5 produced odd spikes in the number of communities for the linear interpolation. let us assume that we are interpolating from adjacency matrix a 0 to adjacency matrix a 1 . let us denote the edges in a 1 that are not in a 0 with the adjacency matrix a add and the edges in a 0 that are not in a 1 with the adjacency matrix a sub . our linear interpolation from a 0 at t = 0 to a 1 at t = 1 would then be if we use a threshold τ such that matrix entries greater than τ are sent to 1 and entries less than or equal to τ are sent to 0, we get two possible interpolation patterns, each with three interpolated values. if τ < 0.5, then if τ ≥ 0.5, then a 0 −a sub will be less connected than either of the interpolation end points, and if τ = 0.5, then a(t) = a 0 − a sub only at t = 0.5. that is why we see that spike in the number of communities. the community similarity results are shown in fig. 10 . with no thresholding, the linear interpolation performs best. both of the geodesics tend to become even less similar to the previous snapshot than the snapshot they are progressing towards, resulting in a u-shape, whereas the linear interpolation has a more consistent decrease. all three interpolations, though, show a sharp decrease in similarity immediately after leaving a snapshot. surprisingly, the le geodesic also produces more extreme results than the ai geodesic. thresholding produces the best result, and it does so with the le geodesic and a threshold of 0.1. the linear interpolation once again shows its piecewise constant behaviour, but fig. 10 community similarity in interpolated proteomics network. when no threshold is applied (bottom right), the le geodesic displays more extreme behaviour than the ai geodesic. a threshold of 0.1 (top right) gives the best performance for the geodesics, a threshold of 0.02 (top left) produces excessive variation in the le geodesic, and a threshold of 0.5 (bottom left) produces almost piecewise constant behaviour in the geodesics. the linear interpolation produces reasonable results when no threshold is applied a threshold of 0.02 is no longer optimal for the le geodesic, and the ai geodesic performs reasonably well at that threshold value. plots of the energy of the interpolated graphs are shown in fig. 11 . when no threshold is applied, the linear interpolation produces an almost linear progression, whereas both geodesic methods go through significant minima between data points. the geodesics are designed to interpolate laplacian eigenvalue products linearly, whereas the linear interpolation produces a linear variation in the eigenvalue sum. linearly changing the sum produces a concave change in the determinant, as we saw in fig. 5 , and we can now see that linearly changing the product produces a convex change in the sum. the interpolations in question are being performed on the laplacian, not the adjacency matrix, but we can see a clear connection. when we look at the thresholded results, we see that the linear interpolation consistently produces graphs with high energy values, the ai geodesic produces graphs with low energy values, and the le geodesic is somewhere in the middle. for the le geodesic, the best threshold value is around 0.02, where the interpolation produces a relatively steady change in graph energy from data point to data point (unlike the linear and ai geodesic interpolations, which basically plateau between points). this is consistent with what we saw in fig. 8 and what we know about sparsity and the different interpolations. finally, we can look at the average graphs calculated using the three different methods. table 2 shows the number of communities for each of the averaged graphs, and table 3 shows the number of communities with at least five nodes in those graphs. the average graph without thresholding showed a much higher level of connectivity than any of fig. 11 graph energy in interpolated proteomics network. applying thresholds of 0.5 (bottom left), 0.1 (top right), and 0.02 (top left) produced the same kind of trends in the interpolations' graph energy as was the case in considering the number of communities: low-energy (i.e., less connected) graphs with the ai geodesic, high energy (i.e., more connected) graphs with the linear interpolation, and graphs of varying energy with the le geodesic. interpolation without a threshold (bottom right) gave similar performance for the geodesics the data snapshots, and this was the case for all of the averaging methods. this would make sense if the community structure changed significantly from snapshot to snapshot. thresholding the average graph produced more reasonable results, though the ai average was highly disconnected, and the linear average showed a very large change in behaviour when the threshold dropped below 0.5. table 3 records results congruent with those in table 2 . with the linear mean graph, we see more communities with at least five members than any of the individual graph snapshots have -again, the linear interpolation produces results with increased connectivity. the riemannian mean graphs without thresholds produce more reasonable numbers of communities, but applying a threshold to the geodesic means severely reduces those numbers. the most reasonable result with a threshold seems to be the le mean with a threshold of 0.02 or the linear mean with a threshold of 0.5. next, we can look at the average difference in community assignment between the mean graphs and the data snapshots in table 4 . the linear mean performs better than the others when no threshold is used, but with a threshold, the best results come from the riemannian means (which are almost identical). these values are quite high -both here and in the interpolation results shown in fig. 10 -and this is likely due to the large number of unconnected nodes. the basic trends in the numbers of communities are reflected in the graph energies recorded in table 5 : the linear averages have very high energy and the geodesic averages have very low energies, with the le averages' energies slightly higher than the ai averages' . what is somewhat surprising, though, is the difference in graph energies between the non-thresholded means -the numbers of communities in each are similar, but the linear average has an energy roughly an order of magnitude higher than the riemannian averages. the energy of the linear mean without thresholding or with a threshold of 0.5 seem to be the most reasonable values. in concluding our observations about these averages, we note that the weights on the linear average graph will all have weights that are multiples of 1/7 (because there are seven data points provided), and thus there will be no difference in results for any two thresholds that lie between n 7 and n+1 7 . this explains why the results for threshold values of 0.02 and 0.1 are the same for the linear average, for example. the geodesic interpolations provide no such structure, and our results here would suggest that low thresholds are generally required to get good results out of the geodesic interpolations. in the appendix, we have provided error bounds for each geodesic interpolation in terms of distance on their respective manifolds. the actual error incurred will depend on the problem in question, though. that kind of error, or even entry-wise error, may not be the most important kind of error to consider for our purposes here, however. rather, we may care most about the community structure. based on our community-related metrics (connectivity and similarity), the le geodesic, with a threshold for the proteomics data, performed the best. the ai geodesic was too sparse and disconnected, while the linear interpolation was too connected (as expected). the optimal choice of threshold value depended on the metric being considered: 0.1 was by far the best when considering community similarity, but 0.02 was better for the other metrics under consideration. in general, the optimal threshold value will likely depend on the problem in question and the quantities of interest, but we found that the le geodesic responded to changes in the threshold value more readily than the ai geodesic did. in this paper, we used the same bias value for all of the proteomics interpolations (10 −6 ), but as mentioned in the "disconnected graphs" section, increasing the bias value caused the geodesic interpolation to approach the linear one. figure 12 shows an example of this where increasing the bias term causes the le geodesic to behave more and more like the linear interpolation (compare with fig. 11 ). future work may involve experimenting with different bias terms to find a happy medium between the linear and pure geodesic interpolations. one concern about the geodesic interpolations is the transient edges that they produceedges that do not exist in either end point but emerge and disappear during the interpolation process. the weights on these edges were small, but they could be positive or negative, and they arose in both the synthetic and proteomics data, so they are not simply an artefact of using the bias addition approach to deal with disconnected graphs. moreover, using a low threshold means that some of these edges may not disappear when that threshold is applied, and therefore they may affect the community structure of the graph. using a larger bias value to more closely approximate a linear interpolation may ameliorate the problem, but it would be valuable to look in more detail at why these transients occur and how to interpret them from a graph theoretic perspective. for example, does it make sense to say that the 'shortest' or 'least energetic' path from one graph snapshot to another might involve some transient edges? from the perspective of the manifold geometry, it clearly does, as the shortest path between two points is a geodesic, but it is not clear if the same holds true purely from a network perspective. in short, the geodesic interpolations are not perfect, and there are still unanswered questions, but it is nonetheless clear that linear interpolation is not well suited to graph interpolation if the ultimate goal is community detection. when using a threshold, linear interpolation will always produce a piecewise constant result consisting of three phases. without thresholding, the linear interpolation inflates overall graph connectivity, and the greater the difference between the two graphs, the greater the inflation. as an extreme example, consider interpolating between a graph with adjacency matrix a to a graph with adjacency matrix 1 − a. the result 'halfway' between them would be a fully connected graph with edge weights of 0.5. these issues are particularly prominent when calculating averages over multiple graphs. perhaps most saliently for our purposes here, the linear interpolation did not produce steady changes in the community structure between data points -the proteomics data showed that the linear interpolation almost always had markedly fewer communities than the data points it connected. the ai geodesic produced transient edges that were smaller in magnitude and fewer in number than the le geodesic, but it was also more expensive and produced graphs that were too sparse (e.g., too few communities); the le geodesic used a similar approach but produced better results when combined with a threshold. similar trends held true, generally speaking, for the mean graphs as well. currently, the computational cost of geodesic interpolation is high because it requires calculating matrix functions like the exponential and logarithm. the le geodesic is noticeably faster than the ai geodesic in calculating interpolated points, though, due to the fractional matrix powers used in the former but not the latter. furthermore, the average graph is significantly easier to calculate for the le geodesic because it has a closed-form expression, whereas the ai geodesic requires an iterated numerical solution. these computational costs are not prohibitive for graphs with hundreds of nodes, but for much larger graphs -say, on the order of 10 6 nodes -the computational cost could render our methods infeasible. one possible approach would be to project the graph laplacians to a lower-dimensional space, perform the interpolation there, and then project back to the original space with some kind of low-rank or sparsity criterion; riemannian optimization on matrix manifolds could be useful for determining an optimal low-rank projection (vandereycken 2013) . another option would be to use graph spectral sparsification (batson et al. 2013 ) to produce sparse graphs that approximate the spectrum of the original graph. we would then perform the interpolation on those sparse graphs. given the close relationship between geodesics and spectral properties, this approach may be better-suited to the geodesic interpolations than to the linear interpolation. either way, it should be possible to come up with an error bound, in terms of the distance between the approximate and true solutions, that relates to the approximation used. as an alternative to thresholding, it may also be possible to identify the laplacians of unweighted graphs that are 'closest' to the geodesic trajectory and use them to define a kind of discrete trajectory of unweighted graphs that most closely approximates the geodesic between two unweighted graphs. this could potentially be more accurate than simply thresholding the adjacency matrix entries. our present interpolation methods match the supplied data points exactly, but the transitions from one interpolation to another are not smooth. it may be valuable to develop more sophisticated interpolation methods that will enforce smoothness, such as polynomial and spline interpolation, using the form of the geodesic interpolations. we may not want to match the supplied graph snapshots exactly, though. instead, we may need to come up with an approximating curve for noisy data. it is possible to define a geodesic that minimizes the sum of squared distances between it and a set of time-indexed data (much like a linear least-squares regression). we could then solve for the regression coefficients in a manner similar to the calculation of the geodesic mean. both higher-order interpolations and least-squares interpolations are possible for the ai and le geodesics, but they may be easier to derive and computationally cheaper for the le versions than the ai versions. regardless of which is used, though, the geometries in which the interpolations are embedded would ensure that the laplacians remain positive-semidefinite and thus representative of real graphs. there is also the option of using other laplacians (e.g., a normalized laplacian). some of these laplacians have spectral properties, such as bounded eigenvalues, that may induce better interpolation behaviour. if these laplacians also have non-constant nullspaces, though, that would add complexity to the interpolation procedure. this would not be a significant hurdle for piecewise geodesic interpolation, but it may be problematic for graph averaging and some of the interpolation expansions described in the paragraph above. we have not yet looked at this problem in detail, however. finally, as mentioned previously, the riemannian framework does not require any one particular community detection method, though it may have some natural connections to spectral clustering. future work with the framework could include comparing different static clustering methods (either analytically or computationally) to see if there are any that would be particularly well-or ill-suited to this kind of interpolation and averaging. we described and implemented riemannian methods for interpolating between and averaging dynamic graph snapshots. following that, we demonstrated the use of these methods on a synthetically generated dynamic graph and an experimentally produced proteomics network and compared them with entry-wise linear interpolation. the linear interpolation increased graph connectivity between interpolation points, and we showed that when a threshold is used to produce unweighted graphs from the interpolation, the entry-wise linear approach will always produce a three-phase piecewise constant result. the geodesic interpolations created using the riemannian methods produced graphs with linearly varying connectivity when applied to connected graph snapshots and produced decreased connectivity between interpolation points when applied to disconnected graph snapshots. we found that using a low threshold on the edge weights improved our results on the disconnected graphs. however, these interpolations produced transient edges (with small positive and negative weights). one area of future work will be to investigate why this behaviour occurs and interpret it in graph theoretic terms. choosing larger bias values when applying these methods to disconnected graphs may improve the quality of the interpolation, from the perspective of graph connectivity, and it may also reduce the presence of transient edges as well. other significant next steps for this work include developing techniques for applying our work to significantly larger graphs and expanding upon our current interpolation methods to produce the riemannian analogues of polynomial interpolation, spline interpolation, and least-squares regression. we cannot say that a linear interpolation will always have the smallest amount of error, but a linear interpolation would haveÿ = 0, so we would expect it to have a smaller error bound than an arbitrary nonlinear interpolation (i.e., one not using higher-order derivative information). we end up with a similar result in considering the distance between a dynamic graph trajectory x(t) through the positive-definite subspace of the laplacian and an ai geodesic interpolation y (t) between x(0) = r 0 and x(1) = r 1 : and commute with each other and with powers of each other (including negative powers) because they have the same eigenvectors. traces of matrix products are also constant under cyclic permutations of those products. we will use these properties to derive an expression for tr ˙ using this matrix commutivity and greene's results on traces of matrix products (greene 2014) : since c (and its powers) commute with exp(ct). therefore,ẏ g y −1 g is constant in time. for the entry-wise linear interpolation, however, there is no closed-form expression foṙ y l or y −1 l ; y l is the positive-definite component of the interpolated laplacian. in general, though,ẏ l y −1 l will not be constant in time. we can then consider the second derivative of the original distance function: d geometric means in a novel vector space structure on symmetric positive-definite matrices spectral sparsification of graphs: theory and algorithms fast unfolding of communities in large networks compex networks, structure and dynamics sustaining the internet with hyperbolic mapping riemannian metric and geometric mean for positive semidefinite matrices of fixed rank energy of a graph encyclopedia of social network analysis and mining the mechanics of rocking stones:equilibria of separated scales dynamical clustering of exchange rates community detection in graphs community structure in social and biological networks traces of matrix products human protein reference database-2009 update curvature and temperature of complex networks hyperbolic geometry of complex networks random walks, markov processes and the multiscale modular organization of complex networks a network integration approach to predict conserved regulators related to pathogenicity of influenza and sars-cov respiratory viruses community structure in time-dependent, multiscale, and multiplex networks dynamic social community detection and its applications a riemannian framework for tensor computing objective criteria for the evaluation of clustering methods finding communities in dynamic social networks community detection in networks with positive and negative links low-rank matrix completion by riemannian optimization the authors would like to thank jason mcdermott for providing the proteomics data used in this study. this work was funded by the microbiomes in transition (mint) initiative at the pacific northwest national laboratory. the authors declare that they have no competing interests. springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. for 1-d linear interpolation, there is a well-defined error bound for the interpolation: a linear interpolation of f (x) from x 0 to x 1 has an error bound ofwe can then consider the euclidean distance between a trajectory x(t) and its approximation y(t), t ∈ [0, 1], from which we can calculate an error z(t):for the geodesic, d dt ẏ g y −1 g = 0, but this will not be the case for the entry-wise linear interpolation. also note the recurrent x − 1 2 x − 1 2 term: x 1 2 x 1 2 is the vector from x to y (pennec et al. 2006) , so x − 1 2 x − 1 2 is essentially a measure of trajectory discrepancy rescaled by x.as with the vector trajectory previously, we cannot say that a given interpolation will always the most accurate one. however, one of the error terms disappears for the ai geodesic interpolation; all other things being equal, it is reasonable to expect that the error on the geodesic interpolation will be, at the very least, less variable than the error on the entry-wise linear interpolation. for extrapolation, the error estimate is no longer relevant for the entry-wise linear method because such an extrapolation is not guaranteed to remain positive-semidefinite. however, the error on the ai geodesic extrapolation is well-defined by the remainder formula in taylor's theorem. for example, extrapolating past r 1 to t > 1 using an ai geodesic built by interpolating from r 0 to r 1 would produce the following error bound:with the derivatives as previously calculated. for the le geodesic,in general, all of these derivative terms will be non-zero. however, for the le geodesic interpolationseveral of the terms in d dt tr ˙ will therefore be zero for the le geodesic. as such, we would expect the error from the le geodesic to be less than the error from the entrywise input interpolation for the same reasons that we would expect the ai geodesic error to be smaller than the entry-wise linear interpolation. we can then plug these results into eq. 40 to get error bounds for the le geodesic. additional file 1: the synthetic data snapshot files begin with 'comm-fixed', and each snapshot file is suffixed with its time index. the proteomics snapshot data files begin with "ppn-numeric" and they are also suffixed with their time indices. the .edges files may be read with a text editor; we recommend textpad. (zip 46 kb) the python implementation of the methods described in the paper. (py 24 kb) additional file 3: a video of the spectral plots created with the ai geodesic interpolation on the synthetic graph data progressing through the data snapshots in order from the initial to the final frame. (mp4 1966 kb) the datasets supporting the conclusions of this article are included in the article's additional files.authors' contributions cb proposed the riemannian framework, performed the mathematical derivations, implemented the methods, generated results, and wrote the main body of the paper. mh obtained the proteomics data, provided the community similarity metric, co-wrote the literature review, offered comments and corrections on the manuscript, and suggested reviewers. as proposed the bias method, wrote code to assist in the community detection, co-wrote the literature review, generated the synthetic data, offered comments and corrections on the manuscript, and suggested reviewers. all authors have read and approved the manuscript. key: cord-255466-g3b283ym authors: bhagra, ojas; patel, shruti r.; chon, tony y. title: an integrated and intergenerational community response to promote holistic wellbeing during the covid-19 pandemic date: 2020-07-02 journal: explore (ny) doi: 10.1016/j.explore.2020.05.018 sha: doc_id: 255466 cord_uid: g3b283ym nan over the past 150 years, groundbreaking improvements in hygiene, pharmacotherapy, advances in medical research, and medical practices have more than doubled the average life expectancy. these advancements not only manifested themselves in preventing death from mild to moderate diseases, but also enabled the ability to combat diseases on global proportions 1 . one clear example we have seen in the past 50 years is the eradication of smallpox, a debilitating disease that infected 300 million people in the 20th century alone 2 . while medicine has made great strides over the centuries, the introduction of unknown diseases causing a pandemic is a threat that has the potential to be even more devastating due to the hyper-connected and globalized nature of our world 3 . the effect of a pandemic is most easily observed on the front-lines; pandemics visibly overwhelm health care systems across the planet by depleting resources and pushing healthcare workers (hcws) to the limit. community and social support for hcws have been shown to improve how hcws perceive their own ability to complete a certain behavior or task, along with decreasing anxiety and stress 4 . in addition to hcws needing community support to relieve the strain of massive patient influxes, pandemics take immense tolls on the mental, emotional, and holistic wellbeing of communities through the lack of connectivity due to isolation, social distancing, and cancellations of major social and life events 5 . therefore, an over-reliance on health care systems and providers alone to tackle pandemic related adverse health conditions is unjustified; a large community involvement component in a pandemic response is not just needed, but critical. every person in a community needs to be involved in a proactive response to promote wellbeing beyond just a physical level as the pandemic negatively impacts all facets of wellbeing. when analyzing the response to a pandemic, beyond the obvious threat of potentially being infected, there are three distinct tolls that an effective integrated and intergenerational community response can help mitigate. these are the tolls on resources, hcws, and the emotional and mental health of a community. we aim to provide a framework for an integrated, intergenerational community response to promote emotional, mental, and holistic wellbeing of hcws and communities. one of the most direct ways a pandemic's impact is felt is through the depletion of necessary resources used to combat or protect against infection. in the case of the covid-19 pandemic, masks have been in severe shortage, leaving many hcws increasingly susceptible to infection. however, beyond standard mask-manufacturers, the people of communities have an enormous potential to help rectify resource shortages via homemade products that follow centers for disease control and prevention (cdc) health guidelines 6 . furthermore, participating in a meaningful part of the pandemic response gives a sense of unity for community members in a time where isolation and lack of control increase the chances to feel helpless or insignificant. currently, the potential for community members to create homemade masks has been utilized extremely effectively in cities around the globe as local organizations and hospitals have opened up their donation lists to masks that meet cdc standards. mobilizing the community to aid mask shortages directly helps another major impact: a massive toll on hcws' emotional and mental health. exhausting recounts of overburdened nurses and doctors being pushed to the brink in order to adequately treat large swathes of patients are diffused through the news, social media, word-of-mouth, etc. a study conducted on medical staff in one of the largest hospitals in the hunan province, the second xiangya hospital, in china, looked at the effect that covid-19 had on the staff's mental health. the study unsurprisingly discovered that the medical staff in the hospital exhibited telltale signs of psychological distress and began to withdraw from their family and social life for fear of bringing the distress or the virus to their loved ones. the hospital attempted to enact several psychological resources and counseling, and although this is an admirable and necessary component of a hospital's response to a pandemic, the results were underwhelming as much of the medical staff refused the formal psychological interventions 7 . the primary role that has been assigned to community members in terms of aiding the burden on healthcare staff is social distancing and flattening the curve. this role, while necessary, focuses merely on one dimension of the pandemic, case numbers. it is important to recognize the impact a community can have on improving the mental health of hcws by addressing their emotional and spiritual needs during a time of crisis. a recent study discovered that there are significant associations between increased social support through the expression of empathy and backing from the community, and decreases in hcws' anxiety, stress, and increases in self-efficacy and sleep quality 4 . in addition, the world health organization (who) recommends for communities to honor hcws and acknowledge the role they play in saving lives 8 . displaying empathy and gratitude is not only helpful for hcws but also to the person giving gratitude. sending cards, making videos, writing positive messages on the sidewalks, whatever it may be, all people of a community should express gratitude and support for hcws as part of a wellrounded pandemic response. promoting community-wide and far-reaching measures to increase wellbeing that leads to an emotionally and mentally healthy, compliant, and resilient community is a necessary approach to overcome a pandemic. communities that have their emotional health addressed are more likely to be compliant and willing to partake in health recommendations like physical confinement and social distancing. as neighborhoods have become the epicenter of interaction in the setting of social isolation, it has become important to focus efforts in these locations. over the past few months, communities have come together in various ways to improve connectivity and wellbeing. across the country, children and adults are finding ways to rejuvenate their neighborhoods with positive messaging, posters in support of hcws, and other virtual community gatherings. community organizations have been offering financial support in the form of small grants to provide direct support to social gatherings (virtual or in-person depending on the state's covid-19 isolation policy) in hopes to relieve the burden of isolation. many of these events following necessary physical isolation guidelines have been focused around integrative and mindfulness practices such as yoga, meditation, mindful movements such as tai chi/ qi gong, as they are credible methods to boost wellbeing and manage stress 9 . it is important to consider that these efforts must be tailored to the architecture of the neighborhood. studies conducted in communities containing people with disabilities have demonstrated more significant levels of isolation when located in urban areas in comparison to rural areas. furthermore, rural respondents felt employment status was more related to social involvement when compared to their urban counterparts, indicating that the effect of normal social interaction occurring at a workplace had a greater effect on rural respondents in terms of perception of social involvement 10 . when aiming to create a neighborhood response in urban and rural communities, these differences are important to consider. an often-overlooked group that has proven pivotal in well-rounded efforts to support wellbeing is the youth members of a community. with the potential to create innovative and powerfully unifying community movements, the youth are unique in their ability to serve many roles from simply helping out a neighbor to coordinating large community movements. around the country, there are remarkable examples of youth in action as they have offered their services to babysit for hcws, shop for seniors, facilitate access to telehealth for seniors, provide tutoring for struggling peers during distance learning, mask-making, and much more to foster emotional, mental, and holistic wellbeing into communities. although pandemics ultimately end up affecting everyone's lives in some shape or form, they disproportionately affect some groups more than others due to the characteristics of the pathogen. in the case of covid-19, the largest vulnerable group is the elderly population in addition to people who are immunocompromised or have underlying health conditions. in a world that was already quite generationally divided, this facet of covid-19 has demonstrated itself to be a catalyst for intergenerational collaboration and support. youth have quickly mobilized to shop for seniors and people of all ages are taking extra precautions primarily to protect elderly people. a keystone of a well-rounded community response should place emphasis on mobilizing all age groups to support vulnerable groups through age-appropriate tasks like helping with everyday life and simply providing connection and interaction. the term social distancing is a misnomer-during this time, removing ourselves from social interactions and connectivity is one of the biggest contributors to the decline of many people's emotional and mental health as it is a basic human need. efforts to retain forms of social interaction are a grassroots, informal, but vital way to instill a sense of normalcy and connectivity to others. an integrated, intergenerational community response is essential to promote emotional, mental, and holistic wellbeing during a pandemic. the toll on resources, hcws, and the emotional and mental health of a community must be supported through grassroots efforts, in conjunction with efforts from a federal and state level. in the end, a community response looks like an everchanging mosaic addressing the active needs of its members. although a crystallized and coherent final form may never be reached, as each new tile of support and involvement is placed, the picture becomes clearer, stronger, and more complete. the result from an integrated and intergenerational community response may not be quantifiable, but it will touch and rectify problems beyond the capabilities of a healthcare dependent response. the expanded programme on immunization: a lasting legacy of smallpox eradication. vaccine the prevention and eradication of smallpox: a commentary on sloane (1755) 'an account of inoculation globalization and pandemics: the case of covid-19 the effects of social support on sleep quality of medical staff treating patients with coronavirus disease 2019 (covid-19) in january and february 2020 in china public mental health crisis during covid-19 pandemic, china. emerg infect dis use of cloth face coverings to help slow the spread of covid-19. ncird, division of viral diseases mental health care for medical staff in china during the covid-19 outbreak. the lancet psychiatry mental health and psychosocial considerations during the covid-19 outbreak mental health strategies to combat the psychological impact of covid-19 beyond paranoia and panic differences in social connectedness and perceived isolation among rural and urban adults with disabilities key: cord-320515-ywwq6lrb authors: wenisch, christoph; bonelli, christine m. title: außerhalb des krankenhauses erworbene pneumonie (community acquired pneumonia cap) date: 2006 journal: wien klin wochenschr educ doi: 10.1007/s11812-006-0013-6 sha: doc_id: 320515 cord_uid: ywwq6lrb nan die pneumonie wird als akute oder chronische entzündung des lungenparenchyms, meist infektiöser, seltener allergischer, chemischer oder physikalischer genese definiert. die entzündung des lungenparenchyms spiegelt sich üblicherweise in einer verschattung (lobulär, segmental, peribronchial) im thoraxröntgen wider. wichtig ist die unterscheidung zwischen einem tiefen luftwegsinfekt (kein radiologisches infiltrat) und der pneumonie wie oben definiert, da nur 5-10% der patienten mit einem klinisch festgestellten tiefen luftwegsinfekt tatsächlich ein radiologisches infiltrat und damit eine pneumonie aufweisen. als cap (community acquired pneumonia) bezeichnet man die außerhalb des krankenhauses erworbene pneumonie. ihr gegenübergestellt wird die gap (gesundheitssystem assoziierte pneumonie), die weiter wie folgt eingeteilt wird: -die nosokomiale pneumonie (spitalspneumonmie, nap) ist eine pneumonie angesichts der nachgewiesenen wirksamkeit und sicherheit der international zugelassenen influenza-impfstoffe wird deren anwendung in all jenen ländern empfohlen, wo eine epidemiologische überwachung eingerichtet ist und wo eine verminderung eine varizellen-immunisierung ist bei jenen menschen angezeigt, bei denen ein erhöhtes risiko besteht, an einer schweren varizellenpneumonie zu erkranken. zu diesen patienten zählen immunkomprimierte patienten, neugeborene, schwangere frauen und jene, die varizellen ausgesetzt waren und keine antikörper aufweisen [17] . zur pneumonie-prävention zählt auch die identifikation und elimination von erregern in der umwelt. treten zwei oder mehr fälle einer legionellenpneumonie, einer psittakose oder eines q-fiebers auf, sollte eine explizite suche nach dem potentiellen erregerreservoir erfolgen, außerdem muss das gesundheitsministerium informiert werden. mit legionellen kontaminierte wassersysteme müssen gereinigt, erhitzt gegebenenfalls chemisch desinfiziert werden. einer legionella-kolonisierung kann durch den gebrauch korrekt angelegter wassersysteme mit versiegelten tanks und durch regelmäßiges erhitzen und chlorierung vorgebeugt werden. husten ist das häufigste symptom der pneumonie (80%), gefolgt von dyspnoe (60-70%), thoraxschmerzen (60%), auswurf (50%) und hämoptysen (15%) [3, 14] . 50% der patienten weisen einen husten mit auswurf auf, wobei dieser zunächst meist nur weißlich schleimig, nicht putrid ist. purulentes sputum entwickeln die meisten erkrankten erst in weiterer folge. eine ausnahme stellen menschen mit einer respiratorischen grunderkrankung wie zum beispiel der copd dar. bei dieser patienten bei stationären patienten kommt es bei etwa 10-20% zu verzögerter besserung der pneumonie [22, 27, 34] , weitere 10% erleben lebensbedrohliche komplikationen bei progressiver pneumonie [32, 41] . bei der behandlung ambulanter patienten nach kontakt mit notfallambulanzen oder niedergelassenen ärzten sind die versagensraten deutlich niedriger: in einer arbeit [30] wurde lediglich eine 2,2%ige hospitalisierungsrate innerhalb von 3 wochen nach einer initialen visite in einer notfallambulanz angegeben. 2 andere berichte mit einer etwas unterschiedlichen definition des therapieversagens zeigen, dass etwa 7% der patienten, die primär ambulant behandelt wurden, später stationär aufgenommen werden mussten [21, 35] . in einer weiteren großen prospektiven studie über außerhalb des krankenhauses erworbenen pneumonien wurde therapieversagen definiert als entweder fehlendes ansprechen oder verschlechterung klinischer oder radiologischer zeichen innerhalb von 48 bis 72 stunden nach primärtherapie mit oralen antibiotika, die eine veränderung der antiinfektiven therapie oder die durchführung einer invasiven abklärung nach sich zogen. hierbei wurde eine 6%ige therapieversagensrate angegeben [40] . wesentlich ist aber auch, eine verzögerte heilung der pneumonie auch mit patientenfaktoren wie fortgeschrittenes lebensalter, alkoholismus und das vorliegen verschiedener grunderkrankungen in beziehung zu setzen [20, 28] . in einer rezenten arbeit (wenisch chemother j 2006, in druck) mit 215 patientinnen mit außerhalb des krankenhauses erworbenen pneumonie wurden 54 (25%) wegen therapieversagens der außerhalb des krankenhauses von der niedergelassenen ärztin eingeleiteten therapie aufgenommen. davon lag bei 33 (15%) patienten ein versagen der von der niedergelassenen kollegin verordneten antibiotikatherapie vor. das therapieversagen trat innerhalb von 8 tagen nach der initialen vorstellung bei der niedergelassenen kollegin auf. die ursachen der aufnahme im spital mit pneumonie unter laufender antibiotikatherapie könnte neben dem versagen der antibiotikatherapie (wobei eine therapiedauer von 1-2 tagen für diese klassifikation kurz ist) auch eine mangelnde ambulante überwachung und unsicherheiten hinsichtlich der compliance sein. im gegensatz zu anderen arbeiten [35, 49] , bei denen die "cap nach ambulanter vortherapie" eher älter waren, waren sie in unserer analyse eher jünger als die primär aufgenommenen patientinnen. das kann daran liegen, dass die patienten in der arbeit von minogue [35] therapie sondern zum versagen einer extrahospitalen antibiotischen therapie kam, zudem war der durchschnittliche pneumonie severity index bei unseren hospitalisierten patienten über 90. auch in unserer arbeit konnte aufgrund der geringen fallzahl resistenter bakterien (n = 3) gegenüber der ambulant begonnenen therapie letztlich kein konklusiver schluss betreffend des stellenwertes der wirkungslosigkeit der antiinfektiven primärtherapie auf das therapieversagen und letztlich das ergebnis geschlossen werden. vielmehr müssen eine vielzahl von patientenfaktoren, die die empfänglichkeit für pneumonie bzw. das ansprechen auf die therapie determinieren, diskutiert werden. so sind erhöhtes lebensalter und eine vielzahl von grunderkrankungen als wichtige risikofaktoren für die pneumonie bekannt. bei älteren patienten kommt es eher zu ineffektivem husten, verlust der lungenelastizität, verminderter mukoziliärer clearance, einer zunahme der funktionalen residualkapazität und abflachen des zwerchfells, verminderte t-zell funktion, verminderte interleukin-und igm-spiegel [44] . rauchen und rezente infektionen (insbesondere influenza im sinne einer superinfektion mit staphylococcus aureus, mykoplasmen, chlamydien) führen zu einer verschlechterung der mukoziliären clearance. weiters werden comorbiditäte faktoren wie herzinsuffizienz, diabetes mellitus, copd, nierenversagen, cerebrovaskuläre erkrankung, alkoholabusus, kortikosteroidverwendung, immunsuppression und neoplasie als unabhängige risikofaktoren nicht nur seit den portstudien als wesentlich für therapieansprechen oder -versagen eingestuft [24, 42, 43] . nachdem unsere patienten bei aufnahme in der "cap nach ambulanter vortherapie"gruppe jünger waren und schließlich eine erhöhte letalität aufwiesen, können natürlich auch genetische faktoren eine rolle spielen [44] . der schwerpunkt der krankenhaushygiene bei der pneumonie liegt in der prävention der nosokomialen pneumonie, die im gesamtspital die zweithäufigste, im intensivbereich die häufigste nosokomiale infektion ist [53, 54] guidelines for the management of adults with community acquired pneumonia: diagnosis, assessment of severity, initial antimicrobial therapy and prevention (eds) respiratory infections. a scientific basis for management humoral and cellular mechanisms phosphatidic acid generation though interleukin 2 (il-2)-induced alpha-diacylglycerol kinase activation is an essential step in il-2-mediated lymphocyte proliferation immune enhanced phagocytic dysfunction in pulmonary macrophages infected with parainfluenca1 (sendai) virus aetiology of cap: a prospective study among adults recquiring admission to hospital a hospital study of cap in the elderly community acquired pneumonia requiring hospitalization: 5 year prospective study new and emerging etiologies for cap with implications for therapy. a prospective multicenter study of 359 cases comparative clinical and laboratory features of legionella with pneumokokkal and mycoplasmen pneumonias prediction of microbial aetiology at admission to hospital for pneumonia from the presenting clinical features. british thoratic society pneumonia research sub committee bundesministerium für gesundheit und frauen (www.bmgf.gr.at), empfehlungen des obersten sanitätsrates decline in invasive pneumococcal disease after the introduction of protein-polysaccharide conjugate vaccine antimicrobial treatment failures in patients with community-acquired pneumonia: causes and prognostic implications repeat consultations after antibiotic prescribing for respiratory infection: a study in one general practice radiographic resolution of community-acquired bacterial pneumonia in the elderly clinical evaluation of the management of community-acquired pneumonia by general practitioners in france utility of fiberoptic bronchoscopy in non-resolving pneumonia international guidelines for the treatment of community-acquired pneumonia in adults: the role of macrolides improving the appropriateness of hospital care in community-acquired 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outpatient treatment for community-acquired pneumonia causes of death for patients with communityacquired pneumonia: results from the pneumonia outcome research team cohort study guidelines for the initial management of adults with community-acquired pneumonia guidelines for the management of adults with community-acquired pneumonia: diagnosis, assessment of severity, antimicrobial therapy, and prevention nonresolving pneumonia and mimics of pneumonia causes and factors associated with early failure in hospitalized patients with commmunity-acquired pneumonia etiology of community-acquired pneumonia: impact of age, comorbidity, and severity nonresponses and treatment failures with conventional empiric regimens in patients with community-acquired pneumonia monotherapy may be suboptimal for severe bacteremic pneumococcal pneumonia genetic susceptibility to pneumonia an international prospective study of pneumococcal bacteremia: correlation with in vitro resistance, antibiotics administered, and clinical outcome comparative radiographic features of community acquired legionnaires' disease, pneumococcal pneumonia, mycoplasma pneumonia, and psittacosis community-acquired pneumonia diagnosis of pneumococcal pneumonia by antigen detection in sputum use of counter and rocket immunoelectrophoresis in acute respiratory infections due to streptococcus pneumoniae predictin death in patients hospitalized for community-acquired pneumonia guidelines for the management of adults with community-acquired pneumonia: diagnosis, assissment of severity, initial antimicrobial therapy and prevention bts guidelines for the management of community-acquired pneumonia in adults richtlinien für krankenhaushygiene und infektionsprävention hygiene ordner des arbeitskreises für krankenhaushygiene d. magistrates der stadt wien, ma 15 ages, inst. f. med. mikrobiologie u. hygiene wien -kompetenzzentrum infektionsepidemiologie key: cord-283744-qkvo6cji authors: marston, cicely; renedo, alicia; miles, sam title: community participation is crucial in a pandemic date: 2020-05-04 journal: lancet doi: 10.1016/s0140-6736(20)31054-0 sha: doc_id: 283744 cord_uid: qkvo6cji nan community participation is essential in the collective response to coronavirus disease 2019 (covid-19), from compliance with lockdown, to the steps that need to be taken as countries ease restrictions, to community support through volunteering. communities clearly want to help: in the uk, about 1 million people volunteered to help the pandemic response 1 and highly localised mutual aid groups have sprung up all over the world with citizens helping one another with simple tasks such as checking on wellbeing during lockdowns. 2 global health guidelines already emphasise the importance of community participation. 3, 4 incorporating insights and ideas from diverse communities is central for the coproduction of health, whereby health professionals work together with communities to plan, research, deliver, and evaluate the best possible health promotion and health-care services. 5 pandemic responses, by contrast, have largely involved governments telling communities what to do, seemingly with minimal community input. yet communities, including vulnerable and marginalised groups, can identify solutions: they know what knowledge and rumours are circulating; they can provide insight into stigma and structural barriers; and they are well placed to work with others from their communities to devise collective responses. such community participation matters because unpopular measures risk low compliance. with communities on side, we are far more likely-together-to come up with innovative, tailored solutions that meet the full range of needs of our diverse populations. in unstable times when societies are undergoing rapid and far-reaching changes, the broadest possible range of knowledge and insights is needed. it is crucial to understand, for instance, the additional needs of particular groups, and the lived experiences of difficulties caused by government restrictions. we know lockdowns increase domestic violence; 6 that rights and access to contraception, abortion, and safe childbirth care risk being undermined; 6 and that some public discourse creates the unpalatable impression that the value of each individual's life is being ranked. identifying and mitigating such harms requires all members of society to work together. past experience should be our guide. grassroots move ments were central in responding to the hiv/aids epidemic by improving uptake of hiv testing and counselling, negotiating access to treatment, helping lower drug prices, and reducing stigma. [7] [8] [9] community engagement was also crucial in the response to ebola virus disease in west africa-eg, in tracking and addressing rumours. 10 coproduction under the pressures of the covid-19 pandemic is challenging and risks being seen as an added extra rather than as fundamental to a successful, sustainable response. good mechanisms for community participation are hard to establish rapidly. high-quality coproduction of health takes time. 11, 12 meaningful relationships between communities and providers should be nurtured to ensure sustainable and inclusive participation. managing participatory spaces takes sensitivity and care to recognise and harness the different types of knowledge and experiences brought by diverse communities and individuals, 13, 14 and to avoid replicating social structures that could create harms such as stigma. so how can we create constructive coproduction in the context of emergency responses to the covid-19 pandemic where time is short? we summarise the key steps in the panel. first, governments should immediately set up and fund specific community engagement taskforces to ensure that community voice is incorporated into the pandemic response. this requires dedicated staff who can help governments engage in dialogue with citizens, work to integrate the response across health and social care, and coordinate links with other sectors such as policing and education. this engagement will require additional resources to complement existing health services and public health policy. dedicated virtual and physical spaces must be established to co-create the covid-19 response, with different spaces tailored to the needs of different participants-eg, different formats for discussion, timings, locations, and levels of formality. second, those of us working to address covid-19 in the health and social care sectors and beyond should look to existing community groups and networks to build coproduction. engagement with such groups is needed to include their voices in local, regional, or national responses to the pandemic. how can we ensure that the most marginalised are represented? how can we ensure front-line providers have a chance to feed into service improvements when they are already working long hours with little respite? third, policy makers working on the covid-19 response should ensure citizens understand that their voices are being heard. showing how policy responses or local actions address specific concerns will help communities believe that their wellbeing is valued and their needs addressed, which in turn will help increase compliance with restrictions and encourage sharing of creative solutions. examples of responses to citizens' concerns have included introducing income guarantees for the self-employed; 15 implementing road closures and widening to allow safer cycling and walking; 16 and policy changes on home use of abortion medication to reduce risk of infection from attending clinics. 17 institutional cultures that support coproduction must be created in political and health systems. 18 we would argue that mechanisms to ensure citizen participation are essential for high-quality, inclusive disaster response and preparedness, and these can be called upon again in future emergencies. all societies have community groups that can co-create better pandemic response and health services and politicians must be supported to incorporate these voices. such public participation will reveal policy gaps and the potential negative consequences of any response-and identify ways to address these together. community participation holds the promise of reducing immediate damage from the covid-19 pandemic and, crucially, of building future resilience. we declare no competing interests. a million volunteer to help nhs and others during covid-19 outbreak. the guardian spaniards find beauty in helping each other amid covid-19 crisis the global strategy for women's, children's and adolescents' health (2016-2030). geneva: world health organization rights in the time of covid-19. lessons from hiv for an effective, community-led response community participation for transformative action on women's, children's and adolescents' health international planned parenthood federation european network. sexual and reproductive health and rights during the covid-19 pandemic: a joint report by epf & ippf en grassroots community organizations' contribution to the scale-up of hiv testing and counselling services in zimbabwe adherence as therapeutic citizenship: impact of the history of access to antiretroviral drugs on adherence to treatment global assemblages: technology, politics, and ethics as anthropological problems social mobilization and community engagement central to the ebola response in west africa: lessons for future public health emergencies slow co-production" for deeper patient involvement in health care ten years of negotiating rights around maternal health in uttar pradesh spaces for citizen involvement in healthcare: an ethnographic study participation, health and the development of community resources in southern brazil guidance: claim a grant through the coronavirus (covid-19) self-employment income support scheme milan announces ambitious scheme to reduce car use after lockdown. the guardian rt hon matt hancock mp. decision: temporary approval of home use for both stages of early medical abortion towards a "fourth generation" of approaches to hiv/aids management: creating contexts for effective community mobilisation key: cord-035182-ax6v3ak5 authors: griebenow, reinhard; mills, peter; stein, jörg; herrmann, henrik; kelm, malte; campbell, craig; schäfer, robert title: outcomes in cme/cpd special collection: how to make the “pyramid” a perpetuum mobile date: 2020-10-27 journal: nan doi: 10.1080/21614083.2020.1832750 sha: doc_id: 35182 cord_uid: ax6v3ak5 continuing medical education (cme) should not be an end in itself, but as expressed in moore’s pyramid, help to improve both individual patient and ultimately community, health. however, there are numerous barriers to translation of physician competence into improvements in community health. to enhance the effect cme may achieve in improving community health the authors suggest a kick-off/keep-on continuum of medical competence, and integration of aspects of public health at all levels from planning to delivery and outcomes measurement in cme. continuing medical education (cme) should not be an end in itself, but as expressed in moore's pyramid [1] , help to improve both individual patient and ultimately community health. however, although the concept of "ascent to the summit" [2] should not be misunderstood as meaning that only a few will be able to reach the peak of mount everest, we need to realise that there is no simple way of improving community health. as illustrated in figure 1 , (1) competence does not inevitably lead to performance: • due to national regulations and/or underfunding of (parts of) health-care systems, availability of treatment may be limited and/or unequally distributed in or between different countries [e.g. [3] [4] [5] [6] [7] [8] . resources to meet challenges such as covid-19 may be insufficient: shortages in staff, beds in intensive care units, respirators or personal protective equipment have uniformly become the responsibility of physicians [9] [10] [11] [12] [13] [14] [15] . in particular in europe, the existence of more than 25 health system jurisdictions in a relatively limited sized area, inevitably leads to a non-uniform picture of medical practice. (2) appropriate performance will not always improve patient health due to: • variation in disease severity or even uncontrollable disease activity • variation in co-morbidities • lack of (informed) consent • patient non-compliance [e.g. [45] [46] [47] • secular changes in risk [48] or • regional/local differences in risk [e.g. [49] [50] [51] • treatment of patient groups excluded from published studies [e.g. 52] (e.g. elderly or patients with comorbidities), for whom the treatment effect has not been validated • health inequities [e.g. 53, 54] considering community health adds a • quantitative dimension: in a theoretical scenario of, for example, a new pharmacological treatment, "level 4/5-cme" would form the competence needed to start ("kick-off-competence", figure 1 ). but targeting community health, requires that cme is informed by results of community health research. this research forms the evidence base, which will keep the process going, and will ultimately lead to improvement of community health ("keep-oncompetence", s. figure 1 ). however, if community (and public) health research should systematically be considered for cme, some important issues have to be addressed: what is a meaningful improvement of community health that cme providers should promote as a benchmark in their cme activities? which role do surrogate endpoints play, in particular when a drug has been approved without evidence that it improves patient prognosis [55, 56] ? so far public health research has often been hampered by restrictions in accessibility of data. this may change for the better with the more widespread use of electronic health records [57] , though (at least in europe) data protection regulations may still interfere with access to patient data [58] . physicians probably always intend that theoretically "all" their (eligible) patients should benefit from, e.g., a new treatment. therefore, is "100%" the benchmark? this has never been resolved in health-care system research, and hagen et al. [62, 71] . further investigation in this complex matter is needed clearly to delineate, to what extent community health effects can be attributed to physicians' primary medical motivation. • quantitative dimension: • worldwide, physicians have claimed professional autonomy in building patient-physician relationships [72] . currently, professional autonomy is most often affected by regulatory actions and commercial interests, in particular the pharmaceutical and medical device industry. considering community health adds further to this list: though health insurance companies or hospital owners do not fall under the accreditation council for cme (accme) definition of a commercial interest [73] , they definitely have a distinct interest in how health-care should be delivered, and part of the health-care system research is based on their data [e.g. 74]. thus, similar to activities to build "kick-offcompetence" we need to define independence of cme also for "keep-on-competence". this includes criteria for institutional conflicts of interest, and bias in content provided by the institutions mentioned above [75] ; the same also applies to regulators in state-driven health-care systems (e.g. nhs in the uk). • the maximum benefit for community health may only be achieved, if we optimise interdisciplinary, and interprofessional cme (and cooperation) [e. g. 76,77]. • community (and public) health research has its own methodological framework, which needs to be addressed in building "keep-on-competence", and • it may have very different sources of information compared to what makes up "kick-offcompetence", which need to be validated in their role to inform "keep-on-competence [e.g. 78]. • selection of faculty in cme targeting community/public health should ideally include all stakeholders, including regulators, politicians, etc. (see also below) • but considering community health also reminds us of our role as expert citizens: back in 1848, the german pathologist rudolf virchow, who had also been a member of the berlin city council and the prussian parliament for many years, had defined the relation between medicine and politics: "medicine is a social science, and politics is nothing more than medicine on a large scale". in the context of cme and community health this highlights that we as physicians have the responsibility to make transparent to the community, as well as their politicians, that treatment of the individual patient will only become effective, if structural changes within the community are also taken. this interdependence of patient care and community care has recently been succinctly demonstrated during the current covid-19 pandemic [e.g. 53, 54, [79] [80] [81] . we may not be in the position of rudolf virchow, who (among others) initiated a sewer system for the city of berlin, and regulation on obligatory assessment of trichinae, binding for all butchers in prussia, but today we still struggle to determine the red line beyond which, we as individual physicians can no longer be able to compensate for deficits, which may only be resolved by political action. thus, cme targeting community health will inevitably be political, and should include all stakeholders in discussing progress and barriers in community health. this also highlights that choosing community health as top of the pyramid is appropriate, since for the large majority of physicians, the community is their professional reference level. however, there will remain issues which can only be resolved by political and subsequent legislative action. what are the implications for the concept of cme, and cme providers? currently, cme is often planned according to the assumption that repetitively updating kick-offcompetence (typically focused on knowledge dissemination), will ultimately have an effect on patient as well as community health. on the one hand there is some evidence for the impact of this strategy on physician performance and patient outcomes [82] , but on the other hand this is not the appropriate strategy to address gaps in community health, and tends to create an attitude of unbalanced activism. it could thus be considered as "division of labour" to continue with "level 1-5" cme activities and stimulate (other) providers to organise more "level 6-7" cme. we should instead promote a different model: change the one-way ticket to a roundtrip, or: make keep-oncompetence the new kick-off-competence (s. figure 1 ). to achieve this goal we need to: • define independence in community/public health research to ensure unbiased content • define which evidence is applicable to the particular community, i.e. introduce research methodology on a case by case basis into each cme activity [75] • make community health part of the needs assessment, content selection, and definition of outcomes • include community health/public health experts within faculty • revise current time schedules, since including community health into cme will in most cases need more time than hitherto, also because • one of the biggest challenges for inclusion of community health into cme on a large scale will be that there is a substantial lack of data at the community level. thus, inclusion of community health matters will probably less often follow a teacher-learner scenario, but will more be a discussion between peers. • revise (if applicable) "knowledge tests" as evaluation of cme, and introduce items with an impact on community health, which can be the more specific as detailed data related to community health are available. • find new ways to integrate community health into cme with primarily international audience (e.g. by presentations of local experts through video conferencing) what are the implications for cme accrediting bodies? community health is the sum of the various forces working for and against community health. in targeting community health cme must therefore take responsibility for discussing all the pros and cons involved in improving community health. current definitions of how to conduct accredited cme theoretically cover aspects of community health [83] . however, most cme currently does not deliberately address community health, since faculty, programme schedules, content, and outcomes, would have to be different in cme aimed at keep-on-competence. this would be accessible to external assessment (as part of the accreditation process), and thus even easier to assess than changes in language, management of data volume, or sources of information in cme [75, 84] . worldwide, accrediting bodies are currently in the process of defining harmonised criteria for accreditation of cme [83] . how to better implement community health-orientated cme might become part of this project. disclosure statements can be found under "supplementary material". achieving desired results and improved outcomes: integrating planning and assessment throughout learning activities ascent to the summit of the cme pyramid can china's 'standard of care' for covid-19 be replicated in europe availability and prices of medicines for non-communicable diseases at health facilities and retail drug outlets in kenya: a cross-sectional survey in eight counties infections associated with resterilized pacemakers and defibrillators beschluss des gemeinsamen bundesausschusses über eine änderung der arzneimittel-richtlinie (am-rl): anlage xii -beschlüsse über die nutzenbewertung von arzneimitteln mit neuen wirkstoffen nach § 35a sgb v -evolocumab geographic access to transcatheter aortic valve replacement centers in the usa. insights from the society of thoracic surgeons/american college of cardiology transcatheter valve therapy registry access to transcatheter aortic valve replacement under new medicare surgical volume requirements covid-19: doctors' visas are automatically extended for one year covid-19: medical students should not work outside their competency, says bma protect our healthcare workers what healthcare professionals owe us: why their duty to treat during a pandemic is contingent on personal protective equipment (ppe) whose life to save? scarce resources allocation in the covid-19 outbreak us ventilator crisis brings patients and doctors face-to-face with life-or-death choices bayesian interpretation of the excel trial and other randomized clinical trials of left main coronary artery revascularization should percutaneous coronary. intervention be considered for left main coronary artery disease? insights from a bayesian reanalysis of the excel trial characteristics of contemporary randomized clinical trials and their association with the trial funding source in invasive cardiovascular interventions evidence for overturning the guidelines in cardiogenic shock levels of evidence supporting american college of cardiology/ american heart association and european society of cardiology guidelines patent foramen ovale closure-closing the door except for trials appropriateness of percutaneous coronary interventions in patients with stable coronary artery disease in us department of veterans affairs hospitals from comparison of patient-reported vs physician-estimated angina in patients undergoing elective and urgent percutaneous coronary intervention pharmacological treatment of depression: a systematic review comparing clinical practice guideline recommendations variation in ventilator allocation guidelines by us state during the coronavirus disease level and prevalence of spin in cardiovascular clinical trial reports with statistically nonsignificant primary outcomes industry sponsorship and research outcomes (review) development and validation of a deep learning algorithm for detection of diabetic retinopathy in retinal fundus photographs psychosocial consequences of false positives in the danish lung cancer ct screening trial: a nested matched cohort study statement on matching language to the type of evidence used in describing observational studies vs. randomized trials grade guidelines: 3. rating the quality of evidence claims of "no difference" or "no effect" in cochrane and other systematic reviews perception of the binding nature of guideline recommendations bindingness of recommendations in guidelines: survey on perception among guideline developers a randomized study of how physicians interpret research funding disclosures information on new drugs at market entry: retrospective analysis of health technology assessment reports versus regulatory reports, journal publications, and registry reports retraction-hydroxychloroquine or chloroquine with or without a macrolide for treatment of covid-19: a multinational registry analysis characteristics associated with out-of-hospital cardiac arrests and resuscitations during the novel coronavirus disease out-of-hospital cardiac arrest during the covid-19 pandemic admissions to veterans affairs hospitals for emergency conditions during the covid-19 pandemic excess deaths from covid-19 and other causes measles status-barriers to vaccination and strategies for overcoming them wald ds adherence to drugs that prevent cardiovascular disease: meta-analysis on 376,162 patients disparities in coronavirus 2019 reported incidence, knowledge, and behavior among us adults introducing the 'drucebo' effect in statin therapy: a systematic review of studies comparing reported rates of statinassociated muscle symptoms, under blinded and openlabel conditions angiotensin-converting-enzyme inhibition in stable coronary artery disease comparison of different cardiovascular risk score calculators for cardiovascular risk prediction and guideline recommended statin uses performance of the framingham risk models and pooled cohort equations for predicting 10-year risk of cardiovascular disease: a systematic review and meta-analysis cardiovascular risk algorithms in primary care: results from the detect study enrollment of older patients, women, and racial/ ethnic minority groups in contemporary acute coronary syndrome clinical trials. a systematic review disparities in the risk and outcomes of covid-19 religious discrimination is hindering the covid-19 response limitations in clinical trials leading to anticancer drug approvals by the us food and drug administration an overview of cancer drugs approved by the us food and drug administration based on the surrogate end point of response rate thrombotic stroke and myocardial infarction with hormonal contraception general data protection regulation prescription rates for antiplatelet therapy in coronary artery disease-which benchmark are we aiming at in continuing medical education? (jecme). zjec 1836866 quality of care after acute coronary syndromes in a prospective cohort with reasons for non-prescription of recommended medications prescription fill patterns for commonly used drugs during the covid-19 pandemic in the usa covid-19-a reminder to reason time course of change in prescription behaviour after targeted continuing medical education in a closed loop system of repeated standardised documentation and feedback use of secondary prevention pharmacotherapy after first myocardial infarction in patients with diabetes mellitus trends in early aspirin use among patients with acute myocardial infarction in china decade-long trends (2001 to 2011) in the use of evidence-based medical therapies at the time of hospital discharge for patients surviving acute myocardial infarction the effect of malpractice reform on emergency department care why aren't physicians prescribing more buprenorphine? comparison of payment changes and choosing wisely recommendations for use of low-value laboratory tests in the usa and canada requests for futile treatments: what mechanisms play a role? results of a qualitative study among dutch physicians mapping the drivers of overdiagnosis to potential solutions wma declaration of seoul on professional autonomy and clinical independence accreditation council for cme definition of a commercial interest busse r: disease management programs for type 2 diabetes in germany-a systematic literature review evaluating effectiveness criteria to assess independence in continuing medical education (cme)-independence through competence and transparency interdisciplinary cme: is the need evident? results of the evaluation of cme articles in the journal of the german medical association association of symptoms of depression with cardiovascular disease and mortality in low-, middle-, and high-income countries assessment of beliefs and attitudes about statins posted on twitter a qualitative study variation in covid-19 hospitalizations and deaths across new york city boroughs associations between built environment, neighborhood socioeconomic status, and sars-cov-2 infection among pregnant women sars-cov-2 positivity rate for latinos in the baltimore-washington, dc region the impact of cme on physician performance and patient health outcomes: an updated synthesis of systematic reviews cologne consensus conference: standards and guidelines in accredited cpd what does cme accreditation stand for? key: cord-017315-3mxkfvvu authors: de leeuw, evelyne title: from urban projects to healthy city policies date: 2016-09-08 journal: healthy cities doi: 10.1007/978-1-4939-6694-3_17 sha: doc_id: 17315 cord_uid: 3mxkfvvu a definition of projectitis (also known as ‘projectism’) is proposed to describe a key barrier to full deployment of a healthy city vision and values. this chapter argues that to put health high on local social and political agendas necessarily means to transcend project-based work, and move into lasting programme and policy development. the conditions for such approaches are favourable in healthy cities, as a number of glocal (global and local) developments invest and sustain longer term perspectives. these conditions include emphases on policy diffusion, social justice, a better understanding of complex systems, and global commitments to the development and implementation of health in all policies. these efforts, in turn, are grounded in renewed and tangible support from universal health coverage and primary health care, asset-based community health development, and better insights into what drives (health) equity and economic development. in describing these elements of policy development for value-based healthy cities the chapter also gives a firm argument for a broad range of stakeholders to engage successfully in longer term policy change. the urban health world is rife with projects-to alleviate poverty, empower communities, provide better roads, increase access to education, secure primary care, etc. many of these initiatives, rightly, have a fixed life. a new school needs to be built; upon completion it requires staff and maintenance: these are entirely different things that can be managed well on a project basis. but a proper policy would take a longer term perspective that includes not just the building and maintenance of the infrastructure. such a policy would set parameters to how infrastructure relates to continued access, how both of these relate to the delivery of a curriculum, and how to undertake regular reviews of accomplishments. goumans and springett (1997) have identified that many healthy cities suffer from projectism. interestingly, although this term (alternated with 'projectitis') has become an integral part of the vernacular of the-critical-government bureaucrat, we have been unable to ascertain an authoritative definition for it. in development studies, pareschi (2002) and little (2005) refer to projectism when they describe the tendency of the international development community (the 'do-gooders' (christensen 2004) in development aid) to impose a project format with defined beginning and end, contained resources (money, people) in time and space, on daily activities undertaken by indigenous communities that by their very nature are organic and ongoing, e.g. the defence of territory, production of food, and political organization. such project 'containment', they assert, can provoke major changes in cultural values, leadership patterns, time conceptions, organizational structure, and political relations in affected indigenous communities. true as this may be, the popularity of projectism/itis suggests that the phenomenon may have detrimental effects in high-income, industrialized nations as well. a definition that reaches beyond indigenous culture into (western) bureaucratic and political values might read 'the reflex, intention and action to contain organisational and community efforts in terms of resource allocation, time, space and conceptualisation purely for the sake of accountability and management purposes, not because the effort at hand necessarily lends itself to such limitation'. goumans and springett (1997) have investigated the potential of healthy cities to move beyond projects and projectism, and found that ample opportunities exist to move into longer term programmes or policies that embed the value base and strategic outlook of the approach. in this chapter we take a look at the conditions that may facilitate such a longer term endeavour. some research suggests that achieving policy innovation, which is required for introducing systemic and sustainable intersectoral perspectives across society, cannot be achieved at the national level, or not at that level alone. policy diffusion researchers (e.g. shipan and volden 2008) argue that local governments drive policy innovation and diffusion of novel policies horizontally to other local governments, and vertically to regional and national governments. for example, policy diffusion facilitated the netherlands' efforts to develop a broad healthy public policy in the 1980s (de leeuw and polman 1995) . global commitments, such as the kyoto protocol for climate change adaptation and mitigation or the framework convention for tobacco control, can be seen as crucial benchmarks for the need to develop new policy types. policy innovation does not happen exclusively bottom-up or top-down, but must be characterized as happening through a process called 'mixed scanning' (etzioni 1967 (etzioni , 1986 in which systems of incremental and reciprocal checks and balances between governance levels create opportunities for change. a key term that has been encountered throughout this book is 'glocal'. 'glocal health' (de leeuw 2001; de leeuw et al. 2006; kickbusch 1999 ) is a term used to recognize and appreciate the intricate and inseparable interface between global developments (e.g. climate change or trade) and local responses (e.g. councils adopting building codes that account for the increased risks of flooding and heat islands, or offering favourable opportunities for local entrepreneurship to engage in international forums). this glocalization dynamic is reciprocal. less likely or desirable global developments may be mitigated-or exacerbated-by local action. for instance, the increasing number of local governments around the world adopting 'zero-carbon emission' policies (e.g. koehn 2008) not only contribute to possible reductions in climate change risks, but also send signals to their colleagues, at local as well as higher government levels, that such actions are feasible and effective. through policy diffusion these local policies impact on global change. in fact, analyses of local government efficacies in the late 1980s and early 1990s led to the introduction of the terms 'glocal' and 'glocalization' into our vocabularies (swyngedouw 1992) . virtually every development and phenomenon in healthy cities has glocal dimensions. so why would we make policy at all? healthy people are an important resource for society. healthy communities are thriving communities, not just in economic terms (because they may more comprehensively contribute to building their common resources) but certainly also in terms of social development and the resilience to cope with shifts and challenges in their social and natural environments. societies and communities with high levels of positive health are resilient. they can face adversity better. a firm expression of the nature of such a health perspective is often found in its definition as engrained in the constitution of the world health organization (1948): health is a state of complete physical, mental, social [and spiritual, larson 1996] wellbeing and not merely the absence of disease or infirmity. in spite of this broad framing of health, in many countries the health service delivery (or 'sick care') sector is not fully embracing these views and their consequences. most healthcare establishments focus on individual treatment and disease prevention, and are challenged to adopt a full social model of health. around the world, the health delivery industry has become a dominant economic sector in its own right and efforts to involve it in actions to promote community health (rather than cure and prevention of disease) face strong beliefs that individual-focused interventions are better, quicker, or more effective. the microbiologist-philosopher dubos (1959) recognized the profound interface between individual and social health and defined health as the expression of the extent to which the individual and the social body maintain in readiness the resources required to meet the exigencies of the future. the key to appreciating this definition is the notion of 'the social body': it refers to community as well as society and its institutions. the institutions can be seen as tangible 'hardware' (hospitals, transport services, bodies of government) but also in a more sociological sense. the formidable ahrendt (1970) saw an institution as 'a body of people and thought that endeavours to make good on common expressions of human purpose'. this idea of an institution (as in 'the institution of marriage' rather than 'the hospital institution') has intimate relations to concepts of government and governance. the ways in which local governments are shaped are functions of both the philosophical and structural views of institutions. in democratic traditions, the assumption is that local government can directly represent constituents and respond to individual, family, community, and neighbourhood needs. but that assumption is firmly based in other assumptions about representation and eligibility of people to partake in the communal and political processes leading to the values that pervade governance, and the resulting shape of government. a key aspiration of modern glocal government is to deliver justice. as spinoza (1670) said, the ultimate end of the state is not dominion, nor restraint by fear, nor the exaction of obedience; on the contrary, its end is to free every man from fear, so that he may live securely. contrast this with ronald reagan's definition of government as like a big baby-an alimentary canal with a big appetite at one end and no sense of responsibility at the other (adler 1981, p. 30) and the clash of political ideologies will be clear. governments can secure and facilitate different forms of justice (e.g. ruger 2005): • procedural justice-decision-making about policy, programme, service design, and delivery-making the composition of decision-making bodies more descriptively representative of the community (in cultural, socioeconomic, gender, etc. senses); and strengthening communities' power to define 'agenda' items independently of the 'dominant culture' • substantive justice-influence-putting items on the agenda, influencing discussion and debate on all agenda items, and influencing the outcomes of decision • distributive justice-ensuring that the population has equitable opportunities to access social resources including high-quality health care, but also preventive services and education, employment, transport, etc. we assert that local government is an expression and instrument of priority setting for shaping the resources for health that dubos describes, and creating the forms of justice that allow people to fully participate. this happens through policy development and the management of social and environmental assets. the growing body of evidence, over recent decades, on the social, political, and commercial determinants of health may well enable local government better than other levels of government and governance to take decisive action. evidence from the other chapters in this book shows that local governments (and especially healthy city ones) are in closer contact with their constituents and would purportedly be able to respond more effectively and quickly to needs expressed. clearly this is an idealtype description: not all local governments are transparent and accountable, and not all people may be, or may feel, represented. this is particularly true for slum dwellers. sometimes urban inequities are literally hidden-in many third world cities the slums and their informal populations are located in gullies and ravines. but in others, the favelas rise up high on the slopes surrounding affluence. it appears that technology can come to a degree of rescue, whether it is enabling social connectedness in nairobi slums (corburn and karanja 2014) or physical connectedness through novel public transportation solutions in medellin, colombia (díez et al. 2015) . local government also has the potential to address the wider determinants of health and health equity. the determinants of health extend far beyond the workings of the health care system, and include the provision and levels of education, the availability of work and employment and standards, the quality of the built and natural environment, the existence of intangible things like a sense of community and solidarity expressed in 'social capital', and the apparent immutability presence of general social gradients between those at the highest and lowest ends of the socioeconomic spectrum. families and communities, and their elected representations in local governments, most directly suffer and enjoy the negative and positive consequences of their decisions on how their lives are shaped in all these domains. complex and connected issues require complex and integral responses. local government does not stand alone in this-it can respond (and has responded, e.g., through the healthy communities and healthy cities networks) more efficaciously to population needs; but at the same time it is bound by regional (provincial, state) and (inter)national contexts. horizontal and vertical collaboration and synergy can and should be sought. analyses of the workings of modern society and its institutional structures (governance, democracy, leadership, etc.) have shown that traditional sectoral and vertical (top-down) responses may yield short-term success but may not address the systemic and complex causes of problems. the consequence of such analyses has been a call for better integration of (and within) problem formulation, policy development, and comprehensive action. such integration would assume equitable access of highly heterogeneous stakeholders to all elements of enormously multifaceted systems (anyone should have access at any time wielding the same influence over the process, no matter who and where they are-a utopian ideal). it is no wonder that solving this issue has eluded politicians, scholars, practitioners, and communities. at an abstract level, the solution has been found in concepts such as 'systems thinking', 'complexity science', and identification of problems as being 'wicked', 'messy', or 'fuzzy'. for policy-making, those terms have translated into perspectives on 'whole of government', 'joined-up government', 'integral government', and 'horizontal government' (carey 2016; carey and crammond 2015; pollitt 2003) . there is a strong argument to be made that these perspectives play out best at the local level because it is there that cooperation between state, market, and civil society actors is considered most likely to produce coordinated planning and action (christensen and laegreid 2007) . the search for whole, joined-up, integral, or horizontal local government approaches achieved momentum, some scholars and politicians claim, since the (perhaps overly zealous) adoption of 'new public management' (npm) principles from the 1980s. in npm citizens are viewed as customers, and public servers/administrators are considered managers of product and service delivery. the assumption of npm was that marketization of public goods would yield greater efficiencies. however, vulnerable, socially excluded, marginal, and under-represented populations in particular often cannot claim a voice of influence and power in this pseudo-economic discourse. governments have tried to repair the resulting gaps in the system with the application of (often cunningly rhetorical) tools that go by monikers such as 'new social partnerships' and 'empowered clients'. in many cases a new balance between complete state control (the 'nanny state' caring for everyone 'from cradle to grave', cf. rivett 1998) and full dissolution of services to commercial sectors is yet to be struck. in the health field, the recognition of 'health' as an issue across social and government sectors has led to the launch of policy perspectives such as 'healthy public policy' and 'health in all policies'. in action terms (that is, for specific intervention development) we have seen the emergence of terms like 'strategic', 'comprehensive', 'multisectoral', or 'intersectoral' action. in the scientific literature we see important efforts to distinguish between all these terms. analysts also suggest ways in which they interrelate. a canadian publication (gagnon and kouri 2008) starts this discussion with a description stemming from australia of 'integrated governance': the structure of formal and informal relations to manage affairs through collaborative (joined-up) approaches which may be between government agencies, or across levels of government (local, state and commonwealth) and/or the nongovernment sector. this describes the overarching principles driving both policy and intervention responses to complex systems issues in health development: managing health, health development, and health equity through collaborative approaches. the current perspective on health in all policies (hiap) finds a basis in the call to develop healthy public policies in the ottawa charter (1986). around the world, governments at all levels have experimented with integrated health policies. some of these actually inspired the pronouncements of the ottawa charter, e.g. the norwegian farm-food-nutrition policy, the chinese 'barefoot doctors' programme, and women's health initiatives in the americas. two initiatives from opposite ends of the world started the developmental process of what now is called hiap. one came from finland during its presidency of the european union in 2006: finland, building on its experience in the long-running north karelia project (labelled a 'horizontal health policy'), urged other members of the union to engage in a horizontal, complementary policy-related strategy contributing to improved population health. the core of hiap is to examine determinants of health that can be altered to improve health but are mainly controlled by the policies of sectors other than health. (ståhl et al. 2006) the other came almost simultaneously from the government of the state of south australia, which identified opportunities for a broad policy programme to invest in the health of its people: health in all policies aims to improve the health of the population through increasing the positive impacts of policy initiatives across all sectors of government and at the same time contributing to the achievement of other sectors' core goals (ståhl et al. 2006 , quoted in baum et al. 2015 rudolph et al. 2013 ). these provided impetus for the organization of the eight global conference on health promotion where a statement and framework were adopted that expressed hiap as follows: health in all policies is an approach to public policies across sectors that systematically takes into account the health implications of decisions, seeks synergies, and avoids harmful health impacts in order to improve population health and health equity. it improves accountability of policymakers for health impacts at all levels of policy-making. it includes an emphasis on the consequences of public policies on health systems, determinants of health and well-being. (world health organization 2014a, b) in different countries and jurisdictions the emphases of the different dimensions of hiap vary. consistently, values (in bold) associated with the concept centre around the importance of collaboration between sectors of public policy-making in good partnership. other aspects where less coherence exists between the different jurisdictions include health equity, the attainment of synergy, hiap leading to or driven by accountability, the character of innovation, ways of integration, and the very nature of policy, e.g.: health in all policies is a collaborative approach that integrates and articulates health considerations into policy making across sectors, and at all levels, to improve the health of all communities and people. health in all policies is a collaborative approach to improving the health of all people by incorporating health considerations into decision-making across sectors and policy areas. (california health in all policies task force) health in all policies is the policy practice of including, integrating or internalizing health in other policies that shape or influence the [social determinants of health (sdoh)] … health in all policies is a policy practice adopted by leaders and policy makers to integrate consideration of health, well-being and equity during the development, implementation and evaluation of policies. (european observatory on health systems and policies) health in all policies is an innovative, systems change approach to the processes through which policies are created and implemented. (national association of county and city health officials) (from rudolph et al. 2013) shifts like these don't just happen. they are the result of, and embedded in, intricately connected webs (kickbusch (2012) identified those for the health promotion endeavour as rhizomes) that grow, dissolve, reconnect, and interact between people, agents, and events. callon (1984) and latour (1987) based their actor-network theory (ant) on such a view of social, policy, and technology development. this is not the place to engage in a fully fledged ant analysis; instead we will list six keystone developments that made the current momentum for hiap possible. one foundation and lasting contribution to our thinking about health in all policies has been the drive towards primary health care (phc). at the who/unicef conference on primary health care in alma ata in 1978, the concept was defined (unicef and who 1978) as essential health care based on practical, scientific and socially acceptable methods and technology. it is made universally accessible to individuals and families in the community through their full participation and at an affordable cost to the community and country. in its further development, phc became more fine grained, and two perspectives emerged. one was a horizontal (comprehensive, systems-driven) approach aligned with a set of strong values around equity, participation, and community-driven bottom-up action for health and well-being, and the other a vertical (disease and health care-driven) approach aligned with the need to address specific (burdens of) disease in many countries, and grounded in existing institutions and patterns in the delivery of clinical interventions. ideology-inspired debates have raged, contrasting the superiority of each approach. reviews show that vertical programmes, particularly those targeting infectious disease morbidity, may yield short-term and specific health gains (e.g. from vaccination campaigns), but that long-term population health development (e.g. aiming at the reduction of the incidence of non-communicable disease [ncd]) does not unequivocally benefit from such selective approaches (e.g. magnussen et al. 2004) . vertical programmes work for particular threats, and horizontal programmes contribute to general well-being. in particular, addressing health equity and ncds does not align well with a selective, vertical approach. evidence has emerged that, depending on the existing health profile and management of (social) determinants of health in different communities and countries, an appropriate balance between the two should be struck. building on a mix between vertical and horizontal primary health care, the aspiration should be to engage in the development of comprehensive health strategies accessible to all (rasanathan et al. 2011 ). in north america, planning emerged as a discipline early in the twentieth century. initially the planning professional focused on urban development, but soon social planning and other areas such as health and environmental planning were added to the repertoire of the planner. considering the 'best' ways of planning, experts before long found that the full participation of people in planning considerations was important. what 'full participation' entailed was (and perhaps continues to be) a matter of debate, and arnstein's 'ladder of participation' as well as davidson's 'wheel of participation' have contributed significantly to insights into the circumstances and degrees of public participation in the planning endeavour. these views have also made a significant contribution to public health and health promotion practice around the world (wallerstein 2006) , in the americas (wallerstein and duran 2006) , and in european healthy cities (boulos et al. 2015; green and tsouros 2008) . a second tradition in this arena was driven by paulo freire's work in the area of community development through new forms of education, famously called 'the pedagogy of the oppressed' (originally published in 1968 in portuguese, translated into english in 1970; his politics of education (1985) gives a good reflective overview). the views espoused by freire and others in this tradition hinge on a philosophy that all in society should be able to engage with personal and social development equitably, through open forms of democracy and decision-making. in order to attain such a capacity, empowerment was, and remains, a key strategy in (local) (health) development. others have taken this important work as a starting point for, for instance, assetbased community development (recognizing that the people in particular social contexts are an important resource for change), deliberative democracy, and a particular form of the latter, participatory budgeting. the 'father of asset-based community development' is john mcknight. he sees community assets as all the potential resources in a community-not only financial, but also the talents and skills of individuals, organizational capacity, political connections, buildings and facilities, and so on (kretzmann and mcknight 1993) . some authors (e.g. page-adams and sherraden 1997) criticize such a broad conceptualization as assets might be taken to mean 'all good things', and in order to make assets more tangible they prefer to frame them in a more economic manner. such a view denies, in our view, the fact that social and health equity both depend on much more than financial and resource capability, and also involve culture, history and heritage, and context (wilkinson and pickett 2010) . the asset model presented by morgan et al. (2010) aims to redress the balance between evidence derived from the identification of problems to that which accentuates the positive capability to identify problems jointly and activate solutions, and so promotes the self-esteem of individuals and communities and leads to less dependency on professional services. this can lead to an increase in the number and distribution of protective/promoting factors that are assets for individual-and community-level health. the asset approach should be seen as the 'shiny' side of the coin. the deficit approach remains valuable in responding to acute crises (at individual, community or societal levels), but in evidence terms at least, the asset model may help to further explain the persistence of health and well-being inequities despite increased efforts to do something about it. harrison et al. (2004) have defined health assets as resources that individuals and communities have at their disposal and that protect against negative health outcomes, or promote health status. these assets can be social, financial, physical, environmental, or human resources (e.g. education, employment skills, supportive social networks, natural resources) (harrison et al. 2004 ). as such, a health asset can be defined as any factor or resource which enhances the ability of individuals, groups, communities, populations, social systems, or institutions to maintain and sustain health and well-being and to help to reduce health inequities. these assets can operate at the level of the individual, group, community, or population as protective (or promoting) factors to buffer against life's stresses. obviously a balance needs to be struck between the intangible assets (skills, knowledge, intents, and aspirations) and the hardware assets of a community (schools, work, infrastructure, etc.). even when both are available there may still be a disconnect between the two: individuals, families, and communities may want to improve their health, but insidious factors such as (health) literacy, culture, sexism, and racism may stand in the way of full and equitable access and use. an asset-based health approach should carefully take into account all elements of a complex individual, social and ecological environment. effectively mobilizing and empowering communities for their health, health equity, wealth, and well-being is an inherently political enterprise and may upset the status quo. not all governments, locally or nationally, may see the full benefits of participation and empowerment. the maturity of government and governance styles as well as patterns of accountability, transparency, and responsiveness to need may not always allow for the full mobilization of community assets. we will return to these challenges later in this chapter. due to a growing recognition that health lifestyle change through traditional behavioural (health education) interventions had limited efficacy, and needed to be embedded in broader social change, the world health organization with health canada and the canadian public health association organized the first international conference on 'the move toward a new public health' in ottawa, in 1986. the conference, followed by a series of global health promotion conferences, culminated in the adoption of the ottawa charter (world health organization et al. 1986 ). the charter defined health promotion as 'the process to enable individuals, groups and communities to increase control over the determinants of health and thereby improve their health'. the conference and its charter saw a responsibility to enable, mediate, and advocate a broad view of health and health action in four areas: • to reorient health services towards a broader, participatory, and health-promoting position in society at any level • to create supportive social, economic, natural, and built environments to create and sustain health promotion and to address the determinants of health equitably • to invest in personal skills and community action to drive and complement these actions • to build healthy public policy, recognizing that health is created across many sectors in society that all have the potential to enhance institutional, community, and personal health reviews of the accomplishments of the ottawa charter have found that substantial progress has been made in our understanding of the drivers of success in each of these fields. our understanding of the complex nature of natural, social, political, and commercial determinants of health has increased, as has our appreciation of the impact of policies on all of these. great advance has been documented in linking ('enabling, mediating, and advocating') individual and community health potential with systemic action on environments for health. the only area where success has been lagging is the reorientation of health services (ziglio et al. 2011) . the global community of health promoters continues to work on the basis of these principles and advances, and implements these especially in the context of 'healthy settings'-a concept that the charter launched: health is created and lived by people within the settings of their everyday life; where they learn, work, play and love. health is created by caring for oneself and others, by being able to take decisions and have control over one's life circumstances, and by ensuring that the society one lives in creates conditions that allow the attainment of health by all its members. health and economic development go hand in hand, although the interface between the two can best be described as 'fuzzy', or in terms of complex systems policy development 'wicked'. the fact that investment in health is a sound economic strategy started to gain traction from the late 1980s and achieved prominence for the first time in the 1993 world bank's world development report investing in health. a strong case was made of the importance to national economies and local communities of addressing health and disease factors that impeded full economic development (jamison 1993) . the report was criticized for espousing new public management and neoliberal principles of outsourcing and privatizing health as a public good (including, e.g., the supply of safe drinking water) and quantifying the impact of disability on economic development through a measure called the 'disability-adjusted life year' (daly) (e.g. navarro 2007 ). however, it succeeded in placing health promotion and public health management on global and local agendas as legitimate strategies for development. the argument for hiap, also at the global level between international bodies, has evolved in the past 20 years with the family of un agencies, including world bank, undp, and who, now mobilized for ncd action. the argument has been developed and refined over the years; for instance, in the jeffrey sachs-led who commission on macro-economics and health. more recently the who commission on social determinants of health (the marmot commission, who commission on social determinants of health (2008)) forcefully indicted unequal economic conditions and pervasive poverty as one of the most critical drivers of health inequity around the world. impressively, the global marmot report has had a number of regional (europe), national (e.g. brazil, england), and local (malmø) reincarnations, highlighting the opportunities and benefits of political action on the social determinants of health. in recent years there has also been a move to take the discourse further, with some starting to address commercial and political determinants of health. recently who and undp issued guidance note on the integration of noncommunicable diseases into the united nations development assistance framework (2015), an expression of the joint-agency work that was an outcome of the high-level meeting at the un in which ncds were given utmost priority. in the guidance note the vicious cycle of poverty and health is described with great insight into the implications of this perspective for local government action. the recognition that health is unequally distributed across populations is not new to the twenty-first century. the terminology used for this phenomenon is possibly as political as its causes and consequences. various terms are pertinent to this discourse, including 'health disparities' and 'health differences' (scholars of the unfair distribution of resources and its consequences in society claim that these are deliberately 'value-free' functional descriptors to obscure the political nature of the issue) and 'the social gradient' (the statistical slope between those at the top of a socioeconomic spectrum and those at the bottom) upon which most health and disease expressions can be mapped. (in)equality, some say, is purely a description of that social health gradient, whereas (in)equity conveys a view of the moral and social injustice of such differences in society. wilkinson and pickett (2010) describe how equitable societies provide and create better opportunities for health for all, including enhanced economic development, sustainability, and educational attainment. striving for equity is not necessarily a requirement or prerogative of national government alone-it depends and thrives on a vibrant civil society and its political representation, extending from local action to global policy and the other way around. equity is a driving concept in various global strategies, including those on climate change, sustainable development, and gender. particularly in the health domain, the work by the marmot commission has been instrumental. its report reviews the causes and consequences of health inequity, and demonstrates that it is possible to close the gap within a generation. policy and action at every level are required to mitigate the possible negative influences of globalization on equity; some authors, however, also allude to the significant potential that global connectedness through new social media may have on an equity agenda. the idea that we live in a globalized world has become a mainstream perspective in the twenty-first century. goods, capital, and knowledge travel, sometimes with the speed of light, around the world. globalization goes beyond the bounded role of the traditional nation-state. indeed, although countries continue to collaborate and expand their vision in the globalized world, the phenomenon to no small extent is driven by commercial interests-but also by a new global civil society. the latter includes ngos like greenpeace, médecins sans frontières, amnesty international, human rights watch, and the peoples' health movement. the actions of this variety of actors on the global scene have made the traditional borders of sovereign states more permeable. no country can thrive without interaction, not just with its neighbours but across the globe, and not just with other countries but with such 'non-state actors'. in discussions about global health governance, experts agree that a new architecture for managing health and health systems in this context is very important. at the same time, new technologies and social media offer new opportunities for knowledge development and community mobilization . local governments around the world see the dissolving integrity of the nationstate as an opportunity to take action. the challenges to the sovereign nature of the nation-state have become prominent during (and in the aftermath of) the sars epidemic; authors such as fidler (2007) argue for a new architecture of global health governance (de leeuw 2013). ncd control, ebola, hiv/aids, the zika and chikungunya viruses, and other health issues have become a global health concern, and new options for policy development at the interface between global and local need to be developed. this has happened through the creation of networks of cities around themes such as climate change and sustainability, age-friendly cities, and knowledge and creativity. assessments of these networks show that such contacts benefit the quality of policy development and actions to improve the quality of life of their citizens. these developments interface with a current discourse about governance. geidne et al. comprehensively review the emergence of the concept of governance as relevant for local health development. they explain that a focus on governance, as complementary to studies of government, derives from a more refined understanding of the scope and nature of the welfare state. this understanding has led to a convergence of ideas that 'government directed by sovereign politicians is not necessarily the most rational arrangement' (geidne et al. 2012, p. 307) . stoker (1998) argues that, despite there being no unequivocal definition of governance, a consensus exists that it refers to the development of governing styles that blur the boundaries between, and within, the public and private sectors. this makes governance a multidimensional and contextually relevant approach to local arrangements for health development, but also a phenomenon that can be construed as a messy research problem (e.g. sinkovics and alfoldi 2012), and 'evidence' for it must be generated in ways beyond the epidemiological paradigm of (quasi-)experimental studies. there is a profound connection between governance and health (e.g. marmot et al. 2008; plochg et al. 2006; vlahov et al. 2007 ). in a foundation report for the who european region health 2020 strategy, kickbusch and gleicher (2012) build on this evidence and argue that there is a difference between health governance and governance for health: (1) the governance of the health system and the strengthening of health systems is called health governance; and (2) the joint action of health and non-health sectors, of the public and private sectors, and of citizens for a common interest is called governance for health. the definition of the latter they propose is the attempts of governments or other actors to steer communities, countries, or groups of countries in the pursuit of health as integral to well-being through both whole-of-government and whole-of-society approaches. in many reports and pronouncements the concepts of health governance, health policy, and health action are used interchangeably, especially when they deal with complex intersectoral endeavours. it is useful to distinguish between these, particularly as there is value in seeing an overlapping. intersectoral governance can be defined as the sum of the many ways individuals and institutions, public and private, manage the connections of their common affairs. it is a continuing process through which conflicting or diverse interests may be accommodated and cooperative action may be taken. it includes formal institutions and regimes empowered to enforce compliance, as well as informal arrangements that people and institutions either have agreed to or perceive to be in their interest. (commission on global governance 1995) in the european region of who, from the early stages of the programme, a commitment to intersectoral governance has been a criterion for designation as a healthy city. from phase ii onwards, cities needed to submit evidence that they had established an intersectoral steering committee (isc) that would oversee policy and intervention development (heritage and green 2013; lipp et al. 2013 ). there are no specific requirements to the design or architecture of such iscs, as they are often driven by unique local contexts and requirements. whether cities lived up to the expectation beyond their formal application commitments was ascertained via annual reporting templates. virtually all members of the network reported that they did establish an isc, although the frequency with which this body met was variable. in some cities it met only once a year, and in others more regularly, up to monthly. in cities where the isc met annually, the role of the body was more at a systems and regulatory level, such as driving and approving policy development and monitoring of intersectoral deliverables; iscs that met more regularly tended to engage more directly in the operational aspects of partnership development, such as allocation of resources and direct supervision of working relationships. both the strategic and the operational aspects of intersectoral governance are important. in their multiple governance framework, hill and hupe (2006) show these different dimensions of governance as complementary requirements for effective and transparent policy development and implementation (fig. 17.1) . intersectoral governance moves between, and encompasses, an architecture in which implicit and explicit rules at a systems level ('institutional design' in fig. 17 .1) explicitly connect to the way in which individuals in collaborative pro-cesses manage their contacts. since healthy cities in europe have been deliberately considered a natural laboratory of health policy innovation at the local level (tsouros 1995) , in hindsight it has been appropriate that the specific terms of reference of iscs have never been spelt out in great detail. this flexibility has allowed the emergence of all types of governance, and an evolution of praxis in which these different levels and types of governance have been tried, tested, and connected. regarding the actual architecture of intersectoral governance arrangements in healthy cities, all designated cities are required to have a coordinating office. similar to the flexibility in terms of reference for the iscs, who has not set specific expectations regarding the organizational positioning of this office. there has been an ongoing debate whether this coordinating body should be directly associated with the local government executive office, that is, as a staff unit appended to the mayor's office (fig. 17.2, model a) , or should be a line unit at a relatively high hierarchical level able to coordinate efforts within government (fig. 17.2, model b) . both models can serve a distinctive purpose, depending on the nature and maturity of the healthy city. the evaluation of phase v revealed another type of governance architecture whereby healthy cities increasingly integrate and devolve the responsibility for intersectoral action for health throughout both the government and civil society. intersectoral action is the engagement of relevant sectors, both within and outside the public policy arena, in the implementation of activities, programmes, and projects that have a multidimensional nature. obesity, for instance, has lifestyle-choice dimensions but must also be addressed through structural interventions in the obesogenic environment (kirk et al. 2010 ), e.g. in public transport, food security, and community development. ideally this requires a policy and managerial context that embraces the values of hiap described below, and it is important that different sectoral stakeholders collaborate effectively. lipp et al. (2013) show that from phase ii through phase iv of the european healthy cities programme, intersectoral action has expanded and strengthened. for example, the 31 cities participating in both phase iii and phase iv increased the extent of partnership working in all sector studies: health services, social services, education, urban planning, voluntary, environmental protection, transport, and economic development. for phase v, farrington et al. (2015) show that healthy cities, in trying to address the prevention of non-communicable disease, also make explicit efforts to work intersectorally in distal determinants of health. european healthy cities, they find, recognize that to make healthier choices easier requires appropriate structuring of the upstream determinants of health. for example, interventions in the built environment to make active living an easier choice include investment in city sports and exercise facilities, investment in cycling infrastructure, and redesignating streets for pedestrians only. successive european healthy cities evaluations therefore show that local governments are not only embracing intersectoral work through the creation and maintenance of appropriate governance architectures, but are also increasingly deploying resources in terms of operational action to deal with complex problems in dynamic partnerships. following the programme logic of realist synthesis, this suggests that the social determinants of health are being addressed more effectively and sustainably. elsewhere i have argued, with clavier and breton, that 'policy' can mean different things to different actors at the same time. a bureaucrat may use the word 'policy' to indicate 'standard operation procedures', a community activist may mean by it 'a dictate coming from above', and a politician may use the term to denote 'an intention to change'. not surprisingly, the same diversity is found in the field of political science. for the purpose of this chapter, and to distinguish meaningfully between governance, action, and policy, we define the latter as the expressed intent of government to allocate resources and capacities to resolve an expressly identified issue within a certain timeframe (de leeuw et al. 2014 ). such an approach clearly distinguishes between the policy issue, its resolution, and the tools or policy instruments that should be dedicated to attaining that resolution. thinking about intersectoral health policy has evolved over the years. healthy cities engage enthusiastically-and beyond mere rhetoric-in the development of health and health equity in all policies. building on a strong foundation in the various political statements on healthy cities over the years and most recently in the athens declaration (tsouros 2015) , local governments work with diverse stakeholders from the public and civil society sectors to develop such policies. the nearly three decades of healthy city development are clearly leaving a legacy, in that healthy cities manage the politics and logistics of interorganizational work effectively. this is clearly dependent on strong yet flexible governance arrangements and demonstrated commitments to the action component of intersectorality (mcqueen et al. 2012a, b) in the evidence on intersectoral policy development and implementation compiled for european healthy cities (de leeuw et al. 2015) , there was an interesting mix between more traditional health approaches, such as a programme on active living in izhevsk, russian federation, and initiatives where the health sector has more peripheral ownership, such as a programme on sustainability in amaroussion, greece. this is precisely the message for effective hiap development-that the health sector has the capacity to share, redistribute, and even disavow ownership of policy initiatives beyond its traditional remit. healthy cities show that such actions do not compromise but strengthen the integrity of health sector policy-making capacity. the above developments have created a strong historical footing for the development of health in all policies. they are, however, often seen as abstract global concepts and aspirations rather than operational local inspirations. in this second decade of the third millennium there are, nevertheless, many reasons why local governments and their communities in particular should be inspired to make a real difference. we compile five themes that drive further action. it is important for society and its communities to spend their resources where they matter. although it can be easily contested what 'where it matters' actually means in different contexts (for instance, a national re-election campaign of a politician based in a megacity would probably not recognize the needs of rural and remote communities to their fullest magnitude), this idea has driven the development of evidence-based (health) policy. substantial impact on this broader aspiration was made by the evidence-based medicine mantra that has its foundation in the work of archibald cochrane. he found that many medical practices were not firmly rooted in evidence of effectiveness (whether something produces the intended result) or efficiency (how well it produces that result). the consequence of this position was that decision-makers, both in policy and in practice, invested in approaches to demonstrate the effectiveness of medical procedures. this effort has had its influence on policies that espouse a broad social model of health and health promotion, both globally and locally. the methods to generate evidence of effectiveness on this arena are, naturally, different from the often controlled circumstances under which clinical procedures can be tried and tested. where in clinical environments an assumption is that an experimental group can be matched with a control group, is it much harder in reality to find the perfect experimental match for, for example, a barrio in medellin, in order to test the effectiveness of social investment. yet very good progress is being made in demonstrating the effectiveness and efficiency of health policy and health promotion. evaluation efforts around healthy cities show that it is easier to achieve public participation and good governance for health at the local level. equity is a concept close to the heart of many local politicians. international research shows that health and health equity impact assessments are not just highly effective tools for measuring the consequences for population health of broad social, environmental, and economic change, but also have a significant impact on the quality and sustainability of policy development and implementation. concepts like healthy urban planning that embrace a wider view of transport and mobility show not just health, but far broader social improvement. the ottawa charter for health promotion also launched the ideas of settings for health ('where people live, love, work and play') as a critical aspect of health development. significant evidence has been accumulated on the efficacy and health impacts of initiatives beyond healthy cities, for instance in health promoting schools (globally the most significant network of settings for health with tens of thousands of participating primary and secondary schools, currently expanding into kindergarten environments), health promoting market places, healthy islands (notably in the pacific through the yanuca declaration, linked to the barbados programme of action), health promoting universities, health promoting prisons, and healthy transport. this evidence continues to be compiled by international organizations like who, undp, iuhpe (the international union for health promotion and education), and other global agencies, but also through networks of civil society like international city networks (e.g. c40 and healthy cities) and academia. there is, in fact, 'metaevidence' that networking for evidence generation enhances the quality, relevance, and responsiveness for glocal action. the enthusiasm and vigour that were originally part of the alma ata declaration on primary health care were rekindled a few years ago when the world health assembly formally re-endorsed the broad social nature of the declaration. it was further sustained by a global campaign to work towards universal health coverage (uhc) at all levels of governance and health system operation. it is defined as ensuring that all people can use the promotive, preventive, curative, rehabilitative and palliative health services they need, of sufficient quality to be effective, while also ensuring that the use of these services does not expose the user to financial hardship (world health organization 2016). in some instances uhc is conceived as an exclusively financial issue that requires fiscal programmes and discipline to redistribute key social resources. the evidence shows that, in fact, the monetary dimension is maybe the least problematic to address. moving from divisive health (delivery) services towards inclusive ones requires much more than the reallocation of resources. uhc has many benefits and creates ample win-win situations, apart from the obvious health gain. they secure a (human) rights-based perspective on population health, have the potential to organize and rally communities for social and economic development, and have the strong potential for higher quality health information collection and management, thus adding to more bespoke evidence-based local health policy. local governments may not always have control over fiscal opportunities and the management of health facilities and professionals. often these are organized and financed at higher levels of governance, and partly for good reason: not every town needs highly specialized neurosurgeons and expensive fmri scanners. but the essential population-based 'first point of contact' with the health system, i.e. primary care, is by its very nature integrated in local communities-even where there may be no doctor. community health workers and local health posts play critical roles in maintaining and integrating universally accessible and appropriate health and social support; they are also the natural champions of (local) community development. even when there are no formal governance arrangements for local government institutions (and in slum areas may even have an informal nature), these professionals and their operational bases are very much part of the social and political landscape of local government. uhc at point of delivery is therefore a concern for local action, whether it has been formalized as a local government remit or not. experiences from the americas, e.g. of people-centred programmes in mexico and brazil, show that uhc is possible and yields significant dividends, not just for population health but more broadly for social development (quick et al. 2014 ). evidence suggests that success of uhc schemes depends on the presence of (1) the strength of organized progressive groups in local communities; (2) the potential of mobilizing adequate economic resources; (3) the absence of significant societal divisions; (4) a weakness of institutions that might oppose it (such as for-profit hospital enterprises); and (5) a skilful identification and opening up of windows of opportunity by (local) policy entrepreneurs (mckee et al. 2013 ). the description of the social gradient in health (that is, the fact that health parameters like mortality, morbidity, and life expectancy follow the patterns of the distribution of wealth, prestige, status, and education in society) has moved from a mere epidemiological curiosity to a political issue. increasing numbers of governments endeavour to place health equity and its causes high on their political agendas. this happens with varying degrees of success. there have been arenas of governance with such a strong belief in their equitable nature that a debate around the sheer existence of health inequity in those societies and communities has been unimaginable. there are also cases where existing inequity is attributed to personal lifestyle choice rather than to broader determinants of health. this so-called lifestyle drift can be inspired either by uninformed behaviourist tendencies (assuming that all human behaviour is entirely within the control of the individual) or by political ideologies like conservative liberalism (assuming that the fate of societies can be entirely attributed to the resourcefulness of its individual members). the evidence, however, demonstrates that individual choice is determined by social, environmental, cultural, economic, natural, and built environments. clearly these interact in extremely intricate ways. they are also the result of political preference, and of commercial interest. both england's report fair society healthy lives and the swedish socially sustainable malmö stress the interrelation between policies that aim to • give every child the best start in life • enable all children, young people, and adults to maximize their capabilities and have control over their lives • create fair employment and good work for all • ensure a healthy standard of living for all • create and develop healthy and sustainable places and communities • strengthen the role and impact of ill-health prevention one of the most prominent challenges in establishing cross-cutting policies and actions is to move outside traditional disciplinary and sectoral boundaries-silos. how did we end up with, and in, those silos? the classic ideal of a good citizen was that of the renaissance man, of whom perhaps the best example is leonardo da vinci (1452-1519), the italian polymath, painter, sculptor, architect, musician, mathematician, engineer, inventor, anatomist, geologist, cartographer, botanist, and writer . typically da vinci would not regard himself as any of these 'professions'-he accomplished all of this without silos. and certainly he was not unique-many advances to modern society have been made by men and women who branched out across scientific disciplines and the arts. this comprehensive integration of the sciences and the arts, not just in one person but in a world view, was challenged in the period of enlightenment, in the sixteenth and seventeenth centuries when the world view evolved towards one of a separation of body and mind, and of distinctly different disciplines arguing that the observed world could be understood mainly through rigorous analysis, that is, deconstructing it into its unique parts. scholars started to focus on particular bodies of knowledge and developed strong theories for each. when in the nineteenth century medicine, as one of these disciplines, became highly professionalized (influenced by the industrial revolution and a growing upwardly mobile middle class) these disciplines started to specialize even further. the process is sometimes called 'hyperspecialization' and today can be witnessed in the proliferation of academic journals focusing on quite particular areas of interest. hyperspecialization is one reason that modern societies operate in management and policy silos. professionalization is another. this is the process of establishing acceptable qualifications, a professional body or association to oversee the conduct of members of the profession, and some degree of demarcation of the qualified from unqualified amateurs. the process creates a hierarchical divide between the knowledge authorities in the professions and a deferential citizenry and creates strong patterns of inclusion and exclusion: building a bridge requires an engineering professional, taking someone to court needs legal professionals, and treating disease must involve qualified medical professionals. specialist and professional segregation are continuously challenged. in the early twentieth century, for instance, debate raged in north america whether public health was within the remit of the medical profession. the matter was resolved with the publication of the flexner report (flexner et al. 1910) , urging a proper 'scientific' approach to clinical medicine teaching, thus excluding public health. in europe-and in countries that followed a european model of health professionalization-medical education continued to include public health matters under the banner of 'social medicine'. specialization and professionalization created formidable commercial and political forces to maintain and protect their status quo. even when the evidence base concerning social determinants of health rationally dictates collaboration and integration of efforts, these forces often prevent successful and effective action and policy development. there is a growing body of rhetorical and evidence-based knowledge that addresses these problems. effective partnering for health starts with the recognition that the capacities of a discipline or specialty in isolation are insufficient to make a difference. the process that enables such a recognition requires the presence of leadership, communication and analytical skills, and something that can be called social entrepreneurship (the capacity to advocate, mediate, and manage opportunities and differences in diverse communities of policy and practice). firm pronouncements by executive offices (e.g. a mayor, ceo, or spiritual leader) in support of reaching out to other sectors are indispensable. reliable and sustainable grounding of such positions in community action helps maintain momentum. such approaches to removing the walls of silos play out at a relatively high level of abstraction; a workforce that is receptive to interdisciplinary work and has been trained to reach out to others is, of course, vital, too. increasingly we see programmes and curricula across primary, secondary, and tertiary education that do in fact embrace such values. the terms intersectoral action (sometimes intersectorial action) and multisectoral action have been part of the rhetorical repertoire of public health and health promotion since the mid-1970s. the terms achieved credence through the alma ata declaration, the ottawa charter, and a series of other pronouncements by global bodies including who. the international discourse has also included arguments and evidence around variations of ideas about working together for health on the spectrum networking-coordinating-cooperating-collaborating (see lipp et al. 2013 for a brief discussion). although there may be conceptual shades of grey around the interpretation of these terms, this focus of public health and health promotion clearly hinges on the noun action. agencies, individuals, groups, and communities may come together to jointly act on health concerns or determinants of health-but this does not necessarily mean that these actions are either driven by policy or result in policy. a series of case studies, however, are starting to build an evidence base that demonstrates that successful intersectoral action may inspire the need for hiap. hiap, however, may not necessarily lead to intersectoral action: for instance, policies to limit lead (pb) content in paints and gasoline are singularly industrial-economic in nature, and apart from commitments required by industry do not necessitate the deep involvement of other government sectors. considering the importance of successful intersectoral action for the development of hiap, it may be worthwhile to reflect on the reasons why it appears such a challenge to break the walls of the silos and move beyond pithy interests. irwin and scali (2010) , at the request of who, assessed the reasons for the failure of intersectoral action and policy to become an 'easy', 'mainstream' effort. they show that intersectoral action for health failed because (1) it was driven by the health sector alone; (2) the intersectoral rhetoric was effectively challenged by the absence of supporting empirical evidence and research programmes to establish such evidence; (3) public health was 'messed up' by new public management ideologies that moved health responsibilities out of government into private and civil society spheres and complicated matters; and (4) international donors and healthcare agencies achieved rapid success with single disease-focused vertical delivery programmes. it appears that, with the resurgence of primary health care, the strengthening of uhc, and an increasing commitment to equity around the world, the seesaw with neoliberalism and free market principles on one side and deeper human values on the other have become balanced again, and that the political climate for successful intersectoral action initiatives is more positive. this is expressed in the commitment to hiap formation and implementation, but the limitations and challenges in the comprehensive embrace of integral action will remain and need to be addressed. this discussion on the critical connection between action and policy raises the question of what the process to attain and sustain health in all policies will entail, and which actors need to be engaged. mcqueen et al. (2012a, b) describe various governance models for hiap. these have been mapped onto the different elements of the policy process ( fig. 17 .3) and hinge on seven best practice models for hiap implementation. different (groups of) government and non-government agencies can play different roles during the hiap process. figure 17 .3 describes some of the governance parameters for positioning hiap development within government structures. in addition to this, we have also identified eight institutionally different structural interaction patterns (fig. 17.4 ) that describe the linkages between the health care system and its public policy agencies (e.g. a ministry of health at the national or provincial level; or a public servant within a local government agency with a public health remit), other public sector agencies and executives (the office eight ways to coordinate between sectors, and implement hiap in integrated or separate action of the president or mayor, for instance), and the shape that intersectoral action for health and health equity may take. it would be an illusion to think that inter-agency integration or collaboration will automatically lead to integrated action. there are many cases where collaboration still leads to a multitude of singular projects without a lot of systemic and synergy consequences. an example might be inter-agency collaboration on road safety: even where there may be agreement on the nature of a road safety issue (e.g. child fatalities) and action is taken, those actions may not be coordinated and sometimes may be counterproductive. road design, improvements, trauma response, safety communications (signage), and behaviour communications (promoting seatbelts and helmets) should be jointly assessed and developed. if they are not, the whole of the roadscape may be messy and confusing and the total effectiveness of interventions significantly decreased. on the other hand, we know examples where the health sector successfully drives systemic and sustainable intersectoral action in cases where the sector is given the opportunity to engage with local communities. an example would be the integration of health checks, childcare, and (health) literacy training in 'casas de cultura' (latin america) or community hubs. key to the success of any approach is the assessment of win-win opportunities, playing to the strengths of each sector and community, 'going with the flow' rather than against it, demonstrating co-benefits to those involved (and that goes beyond government sectors), avoiding turf wars, and a more comprehensive appreciation of different forms of evidence that are generated and applied beyond the health system alone. this includes the exploitation of successful inter/multisectoral action driven by stakeholders outside the health and public sectors. intersectoral action and hiap must not happen for their own sake. collaboration without joint ownership and outcomes, and integrated policy addressing onedimensional issues, is senseless. many lessons have been learned from the integrated partnership agenda in health promotion, particularly in healthy cities (e.g. lipp et al. 2013) . planned action to connect, integrate, and scope the integral policy agenda needs to address the following evidence-based stages: • map and recognize organizational mission and resource capacities and acknowledge the boundaries of the traditional organizational footprint. • describe organizational challenges in addressing issues and populations that permeate and move beyond the organization's legitimate area of concern. • map and include organizations that cover the same, similar, or different issues and populations, or share the same, similar, or different approaches and interventions to deal with these. • recognize the legitimate potential of other stakeholders to be involved in intersectoral action or integral policy development and strive for transparency in sharing these views. • scope the dimensions of probable and possible collaboration and factors that may stand in the way of respectful joint action. • involve real authorities and decision-makers, including organization executives as well as street-level bureaucrats (frontline implementation personnel who deal with inter-sectoral action challenges on an everyday basis), in shaping the joint agenda. • formalize and celebrate each of these stages, as far as possible including individuals, communities, and neighbourhoods that are at the 'pointy end' of the implementation of action and policy outputs. • make all stakeholders in these processes, as far as is culturally and organizationally possible, accountable for their actions, but apply the 'chatham house rule' (full confidentiality of sensitive and strategic considerations) wherever necessary. in this book we have seen that in many local government areas there are already effective structures and processes that would further facilitate the development of inter-sectoral action for health and a strongly associated integral policy development potential. such structures and processes include • an engaged and empowered community • successful experience in deliberative democratic and participatory processes • successful experience in partnerships and collaboration for health and well-being • a broad recognition of the urgency of ncd strategies, supported at executive and council levels • a broad recognition of the 'causes of the causes' of ill health, supported at executive and council levels • an existing agenda to strengthen or move towards universal health coverage • existing role models and examples of inter-sectoral action and hiap in other local governments in the countries, for instance, connected through healthy communities networks • vertical integration of governance models for inter-sectoral action and hiap between different levels of government • existing evidence of social, economic, and sustainability win-win situations, and ongoing connections with local and national agencies and structures that may support the creation and maintenance of such evidence (e.g. local and national universities and ngos) addressing the complexity of modern health and health equity issues requires a lasting, continuous process. the establishment and implementation of one health in all policy in one place cannot be considered the end point. it is a stage in an evolutionary practice: the policy needs to be reviewed, adapted, and renewed to meet the exigencies that it has created. the context, and local stakeholders, in which this happens will constantly change. political shifts may require a renewal of executive commitment; evolving community concerns will dictate ongoing participatory consultative action; and technological advances may inspire new solutions. the local government apparatus will require a firm grounding in flexible understanding of the foundations of inter-sectoral action and hiap, and the processes required to maintain and develop its potential and impact. the above steps, when documented and conscientiously applied, form a local basis for sustained capacity to address new complex health issues through hiap and inter-sectoral action. a form of 'corporate memory' is required to keep such lessons on the radar, and a public repository (virtual or real) can be such a resource. various organizations, often at the interface of policy and practice, offer capacitybuilding programmes that engage with real-life environments and aim to integrate new understanding and improved potential for sustained change in local health development. one example is the learning by doing programme (harris-roxas and harris 2007; pennington et al. 2015 ) that makes local government agents across sectors engage in, and reflect on, health impact assessments. another example is the efforts of the victoria health promotion foundation (australia) to build capacity for local operators to include broad determinants of health thinking (environments for health) in actual processes towards the development of compulsory municipal public health plans through its 'leading the way' programme (vichealth 2002). we started this chapter by asserting that many local initiatives merit a project approach with dedicated temporal and resource dimensions. but to drive those projects in an integrated vision they should transcend themselves, transforming into a perspective that connects an overall vision for the future of a glocal issue or environment. we have described how such vision has been given momentum by developments both local and global, firmly grounded in a set of coherent values including equity, participation, sustainability, and accountability. it is not just preferable to work towards policy for health: it is the only thing to do to respond to the needs of communities, and through integrated connections between sectors, in health in all policies. the reagan wit on violence new norms new policies: did the adelaide thinkers in residence 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health what is the evidence on effectiveness of empowerment to improve health? copenhagen: health evidence network, world health organization regional office for europe using community-based participatory research to address health disparities closing the gap in a generation: health equity through action on the social determinants of health: commission on social determinants of health final report the spirit level: why equality is better for everyone the helsinki statement on health in all policies health in all policies (hiap) framework for country action health in all policies: training manual. geneva: who. world health organization guidance note on the integration of noncommunicable diseases into the united nations development assistance framework ottawa charter for health promotion: an international conference on health promotion-the move towards a new public health health promotion and health systems: some unfinished business key: cord-331867-mqqtzf8k authors: shahsavari, shadi; holur, pavan; wang, tianyi; tangherlini, timothy r.; roychowdhury, vwani title: conspiracy in the time of corona: automatic detection of emerging covid-19 conspiracy theories in social media and the news date: 2020-10-28 journal: j comput soc sci doi: 10.1007/s42001-020-00086-5 sha: doc_id: 331867 cord_uid: mqqtzf8k rumors and conspiracy theories thrive in environments of low confidence and low trust. consequently, it is not surprising that ones related to the covid-19 pandemic are proliferating given the lack of scientific consensus on the virus’s spread and containment, or on the long-term social and economic ramifications of the pandemic. among the stories currently circulating in us-focused social media forums are ones suggesting that the 5g telecommunication network activates the virus, that the pandemic is a hoax perpetrated by a global cabal, that the virus is a bio-weapon released deliberately by the chinese, or that bill gates is using it as cover to launch a broad vaccination program to facilitate a global surveillance regime. while some may be quick to dismiss these stories as having little impact on real-world behavior, recent events including the destruction of cell phone towers, racially fueled attacks against asian americans, demonstrations espousing resistance to public health orders, and wide-scale defiance of scientifically sound public mandates such as those to wear masks and practice social distancing, countermand such conclusions. inspired by narrative theory, we crawl social media sites and news reports and, through the application of automated machine-learning methods, discover the underlying narrative frameworks supporting the generation of rumors and conspiracy theories. we show how the various narrative frameworks fueling these stories rely on the alignment of otherwise disparate domains of knowledge, and consider how they attach to the broader reporting on the pandemic. these alignments and attachments, which can be monitored in near real time, may be useful for identifying areas in the news that are particularly vulnerable to reinterpretation by conspiracy theorists. understanding the dynamics of storytelling on social media and the narrative frameworks that provide the generative basis for these stories may also be helpful for devising methods to disrupt their spread. as the covid-19 pandemic continues its unrelenting global march, stories about its origins, possible cures and vaccines, and appropriate responses are tearing through social media and dominating the news cycle. while many of the stories in the news media are the product of fact-based reporting, many of those circulating on social media are anecdotal and the product of speculation, wishful thinking, or conspiratorial fantasy. given the lack of a strong scientific and governmental consensus on how to combat the virus, people are turning to informal information sources such as social media to share their thoughts and experiences, and to discuss possible responses. at the same time, the news media is reporting on the actions individuals and groups are taking across the globe, including ingesting home remedies or defying stay at home orders, and on the information motivating those actions. 1 consequently, news and social media have become closely intertwined, with informal and potentially misleading stories entangled with fact-based reporting: social media posts back up claims with links to news stories, while the news reports on stories trending on social media. to complicate matters, not all sites purporting to be news media are reputable, while reputable sites have reported unsubstantiated or inaccurate information. because of the very high volume of information circulating on and across these platforms, and the speed at which new information enters this information ecosystem, fact-checking organizations have been overwhelmed. the chief operating officer of snopes, for example, has pointed out that, "[there] are rumors and grifts and scams that are causing real catastrophic consequences for people at risk... it's the deadliest information crisis we might ever possibly have," and notes that his group and others like it are "grossly unprepared" [40] . devising computational methods for disentangling misleading stories from the actual news is a pressing need. such methods could be used to support fact checking organizations, and help identify and deter the spread of misleading stories. ultimately, they may help prevent people from making potentially catastrophic decisions, such as resisting efforts at containment that require participation by an entire citizenry or self-medicating with chloroquine phosphate, bleach or alcohol. 2 as decades of research into folklore has shown, stories such as those circulating on social media, however anecdotal, are not created from whole cloth, but rely on existing stories, story structures, and conceptual frameworks that inform the world view of individuals and their broader cultural groups [49, 62, 68, 71] . taken 1 the broad scale use of hydroxychloroquine as a possible treatment for the virus, which first gained a foothold in social media, is only one example of this feedback loop in action [57] . numerous other claims, despite being repeatedly shown to be false, persist in part because of this close connection between social media and the news [7] . 2 an arizona man died from using an aquarium additive that contained chloroquine phosphate as a source of chloroquine, a potential "miracle cure" touted by various sources, including the u.s. president [72] . several poison control centers had to make press releases warning people not to drink or gargle with bleach [12] . the governor of nairobi included small bottles of cognac in the covid-19 care kits distributed to citizens, erroneously indicating that who considers alcohol a "throat sanitizer" [22] . together, these three features (a shared world view, a reservoir of existing stories, and a shared understanding of story structure) allow people to easily generate stories acceptable to their group, for those stories to gain a foothold in the narrative exchanges of people in those groups, and for individuals to try to convince others to see the world as they do by telling and retelling those stories. inspired by the narratological work of algirdas greimas [28] , and the social discourse work of joshua waletzky and william labov [36] , we devise an automated pipeline that determines the frameworks that form the narrative bedrock of diverse knowledge domains, in this case those related to the covid-19 pandemic [67] . we also borrow from george boole's famous definition of a domain of discourse, recognizing that in any such domain, there are informal and constantly negotiated limits on what can be said:"in every discourse, whether of the mind conversing with its own thoughts, or of the individual in his intercourse with others, there is an assumed or expressed limit within which the subjects of its operation are confined" [10] . we conceptualize a narrative framework as a network comprising the actants (people, organizations, places and things) and the interactant relationships that are expressed in any storytelling related to the pandemic, be it a journalistic account or an informal anecdote [67, 69] . in our model of story telling, individuals usually activate only a small subset of the available actants and interactant relationships that exist in a discourse domain, thereby recognizing that individual storytelling events are often incomplete. this story incompleteness presupposes knowledge of the broader narrative framework on the part of the storyteller's interlocutors. building on folkloric work in rumor and legend, we further recognize that a large number of the stories circulating on and across social networks have a fairly straight forward "threat narrative" structure, comprised of an orientation (the who, what, where and when), a complicating action: threat (identifying who or what is threatening or disrupting the in-group identified in the orientation), a complicating action: strategy (a proposed solution for averting the threat), and a result (the outcome of applying that strategy to the threat) [68] . to determine the extent of narrative material available-the actants and their complex, content dependent interactant relationships-we aggregate all the posts or reports from a social media platform or news aggregator site. for social media in particular, we recognize that participants in an online conversation rarely recount a complete story, choosing instead to tell parts of it [38] . yet even partial stories activate some small group of actants and relationships available in the broader discourse. we conceptualize this as a weighting of a subgraph of the larger narrative framework network. by applying the narrative framework discovery pipeline to tens of thousands of english-language social media posts and news stories, primarily focused on events in the united states and all centered on conspiracy theories related to the covid-19 pandemic, we uncover five central phenomena: (i) the attempt by some conspiracy theorists to incorporate the pandemic into well-known conspiracy theories, such as q-anon; (ii) the emergence of new conspiracy theories, such as one aligning the domains of telecommunications, public health, and global trade, and suggesting that the 5g cellular network is the root cause of the pandemic; (iii) the alignment of various conspiracy theories to form larger ones, such as one suggesting that bill gates is using the virus as a cover for his desire to create a global surveillance state through the enforcement of a worldwide vaccination program, thereby aligning the conspiracy theory with anti-vaccination conspiracy theories and other conspiracy theories related to global cabals; (iv) the nucleation of potential conspiracy theories, such as #filmyourhospital, that may grow into a larger theory or be subsumed in one of the existing or emerging theories; and (v) the interaction of these conspiracy theories with the news, where certain factual events, such as the setting up of tents in central park for a field hospital to treat the overflow of patients, are linked to conspiracy theories. in this particular case, the tents of the field hospital are linked to central aspects of the pizzagate conspiracy theory, specifically child sex-trafficking, underground tunnels, and the involvement of highly visible public figures [34, 67] . running the pipeline on a daily basis during the time of this study allows us to capture snapshots of the dynamics of the entanglement of news and social media, revealing ebbs and flows in the overall story graph, while highlighting the parts of the news graph that are susceptible to being linked to rumors and conspiratorial thinking. conspiracy theories (along with rumors and other stories told as true) circulate rapidly when access to trustworthy information is low, when trust in accessible information and its sources is low, when high-quality information is hard to come by, or a combination of these factors [3, 6, 26, 41, 53, 54, 61] . in these situations, people exchange informal stories about what they believe is happening, and negotiate possible actions and reactions, even as events unfold around them. research into the circulation of highly believable stories in the context of natural disasters such as hurricane katrina [43] , man-made crises such as the 9/11 terrorist attacks in 2001 [24] and the boston marathon bombings in 2013 [66] , or crises with longer time horizons such as disease [4, 30, 32] , has confirmed the explanatory role storytelling plays during these events, while underscoring the impact that stories, including incomplete ones, can have on solidifying beliefs and inspiring real-world action [25, 35] . the goal of telling stories in these situations is at least in part to reach groupwide consensus on the causes of the threat or disruption, the possible strategies that are appropriate to counteract that threat, and the likely outcomes of a particular strategy [68] . in an unfolding crisis, stories often provide a likely cause or origin for the threat, and propose possible strategies for counteracting that threat; the implementation of those strategies can move into real-world action, with the strategy and results playing themselves out in the physical world. this pattern has repeated itself many times throughout history, including during recent events such as edgar welch's attempt to "free" children allegedly being held in a washington dc pizza parlor [45] , the genocidal eruptions that crippled rwanda with paroxysms of violence in 1994 [19] , and the global anti-vaccination movement that continues to threaten global health [13, 32] . although the hyperactive transmission of rumors often subsides once credible and authoritative information is brought to the forefront [4, 70] , the underlying narrative frameworks that act as a generative reservoir for these stories do not disappear. even in times of relative calm where people have high trust in their information sources and high confidence in the information being disseminated through those sources, stories based on the underlying narrative frameworks continue to be told, and remain circulating with much lower frequency in and across various social groups. this endemic reservoir of narrative frameworks serves multiple cultural functions. it supports the enculturation of new members, proffering a dynamic environment for the ongoing negotiation of the group's underlying cultural ideology [18] . also, it provides a ready store of explanatory communal knowledge about potential threats and disruptions, their origins and their particular targets, as well as a repertoire of potentially successful strategies for dealing with those threats [17] . when something does happen that needs explanation-and a possible response-but for which high trust or high confidence information sources do not exist, the story generation mechanism can shift into high gear. the endemic reservoir of narrative frameworks that exists in any population is not immutable. indeed, it is the ability of people to change and shape their stories to fit the specific information and explanatory needs of their social groups that makes them particularly fit for rapid and broad circulation in and across groups [68] . while the stability in a story telling tradition suggests that the actants and their relationships are slow to change, their constant activation through the process of storytelling leads to dynamic changes in the weighting of those narrative framework networks; new actants and relationships can be added and, if they become the subject of frequent storytelling, can become increasingly central to the tradition. because of their explanatory power, stories can be linked into cycles to form conspiracy theories, often bringing together normally disparate domains of human interaction into a single, explanatory realm [41, 33] . although a conspiracy theory may not ever be recounted in its entirety, members of the groups in which such a theory circulates internalize, through repeated interactions, the "immanent" narrative that comprises the overall conspiracy theory [14] . in turn, conspiracy theories can be linked to provide a hermetic and totalizing world view redolent of monological thinking [27] , and can thereby provide explanations for otherwise seemingly disjoint events while aligning possible strategies for dealing with the event to the story teller's cultural ideology [68] . summarizing the storytelling of thousands of story tellers and presenting these stories in an organized fashion has been an open problem in folkloristics since the beginning of the field. the representation of narratives as network graphs has been a desiderata in narrative studies at least since the formalist studies of vladimir propp [50] . lehnert, in her work on the representation of complex narratives as graphs, notes that these representations have the ability to "reveal which concepts are central to the story" [39] . in other work specifically focused on informal storytelling, bearman and stovel point out that, "by representing complex event sequences as networks, we are easily able to observe and measure structural features of narratives that may otherwise be difficult to see" [5] . later work on diverse corpora including national security documents has shown the applicability of the approach to a broad range of data resources [46] . the automatic extraction of these graphs, however, has been elusive given the computational challenges inherent in the problem. in the context of conspiracy theories, preliminary work has successfully shown how simple s-v-o (subject-verb-object) extractions can be matched to a broader topic model of a large corpus of conspiracy theories [55] . work in our group has shown how the extraction of more complex structures and their concatenation into complex narrative graphs provides a clear overview of, for example, the narrative framework supporting the decision to seek exemptions from vaccination among "antivax" groups posting on parenting blogs [69] . recent work on rumors and conspiracies focuses specifically on the covid-19 pandemic [1, 23, 74 ]. an analysis of german facebook groups whose discussions center on the pandemic uses a similar named entity analysis to our methods, and shows a strong tendency among the facebook group members to resist the news reported by recognized journalistic sources [9] . a study of the chinese social media site weibo revealed a broad range of concerns from disease origin and progression to reactions to public health initiatives [42] . an examination of 4chan that employs network analysis techniques and entity rankings traces the emergence of sino-phobic attitudes on social media; these attitudes are echoed in our narrative frameworks [58] . in earlier work, we have shown how conspiracy theories align disparate domains of human knowledge or interaction through the interpretation of various types of information not broadly accessible outside the community of conspiracy theorists [67] . we have also shown that conspiracy theories, like rumors and legends on which they are based, are opportunistic, taking advantage of low information environments to align the conspiracy theory to unexplained events in the actual news [4] . such an alignment provides an overarching explanation for otherwise inexplicable events, and fits neatly into the world view of the conspiracy theorists. the explanatory power of this storytelling can also entice new members to the group, ultimately getting them to ascribe to the worldview of that group. data for this study were derived from two main sources, one a concatenation of social media resources composed largely of forum discussions, and the other a concatenation of covid-19-related news reports from largely reputable journalistic sources. we devised a scraper to collect publicly available data from reddit subreddits and from 4chan threads related to the pandemic. the subreddits and threads were evaluated for relevance by three independent evaluators, and selected only if there was consensus. all of the data are available in our open science framework data repository [60] . 3 for 4chan, we collected ∼ 200 links to threads for the term "coronavirus", resulting in a corpus of 14712 posts. the first post in our corpus was published on march 28, 2020 and the final post was published on april 17, 2020. for reddit, we accessed ∼ 100 threads on various subreddits with 4377 posts scraped from the top comments. because these top comments are not necessarily sorted by time but rather by the process of up-voting, we did not include these timestamps in our analysis. specifically, we targeted r/coronavirus and r/covid19, along with threads from r/ conspiracy concentrating on corona virus. we removed images, urls, advertisements, and non-english text strings from both sources to create our research corpus. after running our pipeline, we were able to extract 87079 relationships from these social media posts. for news reports, we relied on the gdelt project, an open source platform that scrapes web news (in addition to print and broadcast) from around the world (https:// www.gdeltproject.org/). 4 our search constraints through this dynamic corpus of news reports included a first-order search for conspiracy theories. the corpus was subsequently filtered to only include articles written in english (gdelt built-in feature) from u.s. news sources. the top 100 news articles (as sorted by the gdelt engine) were aggregated daily from january 1, 2020 to april 14, 2020 (prior to filtering), and the body of each filtered news report was scraped with newspaper3k. these articles were then cleaned and staged for our pipeline to extract sentence-level relationships between key actors. we extracted ∼ 60 relationships from each report, ∼ 50 filtered news reports per day, and 324510 relationships. the methods used here are a refinement of those developed for an earlier study of conspiracies and conspiracy theories [67] . we estimate narrative networks that represent the underlying structure of conspiracy theories in a large social media corpus (4chan, reddit) where they are most likely to originate, and the corresponding reporting about them in the news (gdelt). this approach allows us to analyze the interplay between the two corpora and to track the time-correlation and pervasive flow of information from one corpus to the other. the latent structure of the social media networks also provides features which enable the identification of key actants (people, places and things) in conspiracies and conspiracy theories, and the detection of threat elements in these narratives. the following subsections introduce the graphical narrative model for conspiracy theories in social media as well as the pipeline for processing news reports. the end-to-end automated pipeline is summarized in fig. 1 . we model narratives as generated by an underlying graphical model [67] . the narrative graph is characterized by a set of n nodes representing the actants, a set of r relationships r = {r 1 , r 2 , … , r r } defining the edges, and k contexts c = {c 1 , c 2 , … , c k } providing a hierarchical structure to the network. these parameters are either given a priori or estimated from the data. a context c i is a hidden parameter, or the 'phase', of the underlying system that defines the particular environment in which the actants operate. it expresses itself in the distributions of the relationships among the actants, and is captured by a labeled and weighted network , where each such pair is labeled with a distribution over the relationship set r. each post to a thread describes relationships among a subset of actants. a user picks a context c i and then, from the network, draws a set of actants and inter-actant the forum posts constitute the output of this generative process. from a machine learning perspective, given a text corpus, we need to estimate all the hidden parameters of the model: the actants, the contexts, the set of relationships, and the edges and their labels. in other words, it is necessary to jointly estimate all the parameters of the different layers of the model. 5 first, each sentence in our corpus is processed to extract various syntax relationship tuples. some tuples are described as (arg 1 , rel, arg 2 ) where each arg i is a noun phrase and rel is a verb or other type of relational phrase. others include subject-verb-copula (svcop) relationships that connect a subject to a copula or subject complement. the relationship extraction framework combines dependency parse tree and semantic role labeling (srl) tools used in natural language processing (nlp) [15] . we design relationship patterns that are frequently found in these narratives, and then extract tuples matching these patterns from the parsed corpus. the phrases arg 1 and arg 2 , along with entity mentions obtained using a named entity recognition tool [2] , provide information about the actant nodes and the contexts in which they appear. noun phrases are aggregated across the entire corpus into contextually relevant groups referred to as super-nodes or contextual groups (cgs). several different methods of clustering noun phrases and entity mentions into semantically meaningful groups have been proposed in the literature [51] . we accomplish the aggregation presented here by generating a list of names across the corpus, which then acts as a seed list to start the process of creating cgs from the noun phrases. we group nouns in the ner list using co-occurrence information from the noun phrases. for example, "corona" and "virus" tend to appear together in phrases in our corpus (see table 1 ). we leverage recent work on word embedding that allows for the capture of both word and phrase semantics. in particular, the noun phrases in the same contextual group are clustered using an unsupervised k-means algorithm on their bert embeddings [20] . while the process of merging and deleting the subnodes detailed in prior work [67] offers flexibility over the choice of k we chose k = 40 as a conservative parameter to preserve the resolution of cluster members. in prior work [67] , we have shown that the final network comprising sub-nodes and their relationship edges is not sensitive to the exact size and content of the contextual groups derived at this stage. this cg grouping, which we undertake prior to applying k-means clustering on word embedding, enables us to distill the noun phrases into groups of phrases that have a semantic bias. this distillation mitigates the inherent noise issues with word embeddings when they are directly used to cluster heterogeneous sets of words over a large corpus [56] . the cgs can also be viewed as defining macro-contexts in the underlying generative narrative framework. it is worth noting that the nodes are not disjoint in their contexts: a particular sub-node might have phrases that are also associated with other sub-nodes. these sub-nodes, when viewed as groups, act as different micro-contexts of the supernodes in the overall model. the final automatically derived narrative framework graph is composed of phrase-cluster nodes or, "sub-nodes", which are representations of the underlying actants. we automatically label these sub-nodes based on the tf-idf scores of the words in each cluster resulting from the k-means clustering of the contextual groups. the edges between the sub-nodes are obtained by aggregating the relationships among all pairs of noun phrases. thus, each edge has a set of relationship phrases associated with it, and the number of relationships can serve as the weight on that edge. the relationship set defining an edge can be further partitioned into semantically homogeneous groups by clustering their bert embeddings [20, 67] . because conspiracy theories connect preexisting domains of human activity through creative speculation, often presented as being based on a theorist's access to "hidden knowledge", we expect that the narrative frameworks that we construct will have clusters of nodes and edges corresponding to the different domains. since these clusters are densely connected within themselves, with a sparser set of edges connecting them to other clusters, we can apply community detection algorithms to discover them. for example, the domain of "public health" will have dense connections between sub-nodes such as "doctors" and "hospitals", with relatively few connections to the domain of "telecommunications", which will in turn have dense connections between sub-nodes such as "5g" and "cell towers". traversing these different communities mimics the conspiracy theorist's cross-domain exploration in the attempt to create a conspiracy theory. given the unsettled nature of discussions on social media concerning the covid-19 pandemic, it seems likely that there are multiple, competing conspiracy theories in the corpus. therefore, one would expect to find a large number of communities in the overall network, some isolated from the rest and others with a limited number of shared sub-nodes. one would also expect that this network would have a hierarchical structure. to capture any such hierarchical structure, we compute overlapping network communities, where each community is defined by (i) a core set of nodes that constitute its backbone, and (ii) a set of peripheral nodes of varying significance that are shared with other communities. currently, to determine the communities in our network, we run the louvain greedy community detection algorithm multiple ( ∼ 1000 ) times using the default resolution parameter in networkx [8] . we define two nodes as belonging to the same core if they co-occur in the same community for almost all of the runs; here we use a threshold of 850. as in [67] , the threshold is aligned with the precipitous drop in the size of the giant connected component (gcc). next, a core that defines a community is a set of nodes that is closed under the co-occurrence transitive relationship: if nodes a and b belong to the same core, and nodes b and c also belong to that same core then, by transitivity, we say nodes (a, b, c) are all in the same core. the resulting disjoint sets of core nodes (i.e., equivalence classes under the co-occurrence transitive relationship), along with their edges in their original network, define non-overlapping communities that form the multitude of narrative frameworks in the corpus. 6 overlapping nodes are then brought into the communities by relaxing the co-occurrence threshold [67] . 7 these interactions among core communities, and hence, the respective narrative frameworks, capture the alignments among multiple knowledge domains that often underlie conspiracy theories. taken as a whole, the narrative framework comprising networks of actants and their inter-actant relationships (along with other metadata) reveals aspects of conspiracy theories including the threatening sub-nodes identified by the conspiracy theorists, and the possible strategies that they suggest for dealing with those threats. for instance, the network community consisting of sub-node [tower, 5g, danger] along with its associated svcop relationships "[5g] is deadly", "[tower]s should be burned", imply a threat to human well-being posed by 5g, and a strategy for dealing with that threat: burn the cell towers (strategy) to protect people from the deadly 5g (threat). because threats are often followed by strategies, we prioritize the classification of threats. to classify threats, we look for sub-nodes in the network communities that, given their associated descriptions, might be considered threatening. for example, a descriptive reference to a sub-node "vaccines" that suggests that they "can kill", would allow us to code "vaccines" as a possible threat. we repeat this process for all the sub-nodes in the network communities, and find that strong negative opinions are associated with some subset of sub-nodes, which we identify as candidate threats. by applying a semi-supervised classification method to these candidate subnodes, we can confirm or reject our suspicions about their threatening nature. the threat classifier is trained on the relationships extracted from social media posts. in particular, svcop relationships (described in section 4.1) play a special role in providing information about a particular sub-node: these relationships provide important information about the first argument and are generally descriptive in nature. in such relationships, the second argument is most often a descriptive phrase with an associated to-be verb phrase. for example (5g,is,dangerous/a threat/harmful) are svcop relationships describing the [5g] argument. we consider these relationships as self-loops for their first arguments, which are aggregated into sub-nodes. the most discussed sub-nodes tend to have a high number of such self-loop relationships, and the descriptive phrases often carry powerful characterizations of these entities. sub-node-specific aggregation of these relationships can inform us about the role of a particular actant in its community. for example, we find ∼ 350 svcop relationships describing the node "virus" as "harmful", "deadly", "dangerous", and "not real". we aggregate the entire corpus of svcop relationships ( ∼ 10000 ) and then label them in a hierarchical fashion as follows: first, each such svcop phrase is encoded using a 768 dimensional bert embedding from a model fine-tuned for entailment detection between phrases [20] . next, the vectors are clustered with hdbscan [44] , resulting in a set of ∼ 1000 density-based clusters c, with an average cluster membership size of 7. approximately, 3000 of the phrase encoding vectors are grouped in a cluster labeled as −1 , indicating that they are not close to others and are best left as singletons. for the rest, each cluster represents a semantically similar group, and can be assigned a group semantic label. thus, the task of meaningfully labeling ∼ 10000 phrases as 'threat' or 'non-threat' is reduced by almost a factor of 10. we define a binary label for each cluster. a threat is a phrase that is universally recognized as threatening: [5g] is dangerous, [a tower] is a bioweapon. here, the phrases dangerous and bioweapon are clearly indicative of threats. the remaining phrases are labeled as neutral/vague comments. for every cluster c ∈ c , we assign a label l c to c such that every descriptive phrase d ∈ c is also assigned label l c . clearly, label quality is contingent on the manual labeling of the clusters and the semantic similarity of descriptive phrases as aggregated by the bert and density-based clustering. this is ensured by three independent reviewers labeling each cluster and, in the case of disagreement, choosing the label receiving the majority vote (report krippendorf alpha here). we measure the inter-rater reliability with respect to the majority vote by the three different raters. our results for a sample size of 100, are 0.745, 0.87 and 0.829. the semantic similarity in each cluster is verified by a qualitative analysis of the clusters undertaken by domain experts. for example, most of the clusters have exact phrase matches such as these labeled phrases are used to train a k-nearest neighbor (knn)-based phrase classifier to identify threatening descriptions. once again we use the fine-tuned bert embedding. many competing knn models provide useful classification results for phrases. we found that setting k = 4 results in a model that reasonably classifies most phrases. the knn classifier is binary: 0 represents the class of non-threat and 1 represents the class of "threat". the cross-validation part is carried out at the level of the clusters: that is, when designing the training sets (for knn, the set of phrases used in performing the knn classification of a given phrase) and validation sets, we partition the phrases based on their cluster assignments. all phrases belonging to the same cluster are assigned to the same set and are not split across the training and validation sets. because the labeled phrases have duplicate second arguments and repeated phrases occur in the same cluster, this approach to cross-validation ensures against repeating phrases in both the training and validation set, which is achieved by partitioning data at the cluster level. the primary purpose of designing the phrase classifier is to identify threatening sub-nodes, which appear as core nodes in the narrative framework communities. aggregated second arguments of svcop relationships corresponding to a particular sub-node are classified with the knn phrase classifier. based on a majority vote on these second arguments, we can classify a sub-node as a potential threat. an outline of this algorithm is provided in algorithm 1. a narrative framework for a conspiracy theory, which may initially take shape as a series of loosely connected statements, rumors and innuendo, is composed from a selection of subnodes from one or more of these communities and their intra-and inter-community relationships. each community represents a group of closely connected actant sub-nodes with those connections based on the context-dependent inter-actant relationships. traversing paths based on these inter-actant relationships within and across communities highlights how members posting to the forums understand the overall discussion space, and provide insight into the negotiation process concerning main actants and inter-actant relationships. this search across communities is guided by the extended overlapping communities (which connect the core communities), as described in 4.1, taking into consideration the sub-nodes that are classified as threat nodes. the inter-actant relationship paths connecting the dominant threat nodes, both within and across communities, are then pieced together to create the various conspiracy theories. many conspiracy theories detected in social media are addressed in news reports. by temporally aligning the communities discovered from social media with the evolving communities emerging from news collected daily, we can situate the 4chan commentary alongside mass media discussions in the news. such a parallelism facilitates the analysis of information flow from smaller community threads in social media to the national news and from the news back to social media. to aggregate the published news, we consider (1-day time-shifted) intervals of 5 days. this sliding window builds s = 101 segments from january 1, 2020 to april 14, 2020. we have discovered that a longer interval, such as the one chosen here, provides a richer backdrop of actants and their interactions than shorter intervals. in addition, narratives on consecutive days retain much of the larger context, highlighting the context-dependent emergence of new theories and key actants. we use the major actants and their mentions discovered in the social media data to filter the named entities that occur in the news corpus. a co-occurrence network of key actants in news reports (conditioned on those discovered from social media), provides a day-to-day dynamic view of the emergence of various conspiracy theories over time. in addition, we model the flow of information between social media and news reports by monitoring the frequency of occurrence of social media communities (as captured by a group of representative actants in each community) in the text of news reports (see evaluation). with minimal supervision, a few actant mentions are grouped together including, [trump, donald]: donald trump, [coronavirus, covid19, virus]: coronavirus and [alex, jones]: alex jones. while such groupings are not strictly required and could be done more systematically (see [59] ), this actant-grouping enhances the co-occurrence graph by reducing the sparsity of the adjacency matrix representing subject-object interaction. for each 5-day segment of aggregated news reports, the corpus of extracted relationships r i and the associated set of entities e i are parsed with algorithm 2 to yield a cooccurrence actant network. day-to-day networks reveal the inter-actant dynamics in the news. while many metrics can be used for summarizing the dynamics within these networks, we considered the number of common neighbors (ncn) between them. if the adjacent vertices of a 1 are s a 1 and of a 2 are s a 2 , the ncn score is defined as: we temporally align the conspiracy theories discussed in social media and in news reports by first capturing a group of representative actants in each social media community. let the set of keywords representing a particular community be v i . the timestamps present in 4chan and gdelt data make these corpora suitable for temporal analysis with respect to v i (our reddit corpus does not contain dates). to facilitate a comparison between the two corpora conditioned on v i , let c j denote the raw 4chan data and d j denote the raw gdelt news data in time-segment j. the time segments are 5-day intervals between march 28,2020 and april 14, 2020, which is the intersection of date ranges for which we have temporal 4chan and gdelt data. we define a coverage score (m) that captures the presence of actants from v i in c j and d j . (1) n a 1 ,a 2 = |s a 1 ∩ s a 2 |. to normalize the coverage scores to a baseline, we compute a relative coverage score (r), where v * is a random set of actants (of size 500) as: computed across all time-segments, r c (v i ) and r d (v i ) represent a series of relative coverage scores for 4chan and gdelt, respectively, with one sample for every time segment. this metric now provides a normalized measure for coverage of a community derived from social media in the temporal corpora of 4chan and gdelt data. the cross-correlation function of these relative coverage scores can provide interesting insight into the co-existence of conspiracy theory communities in the two corpora where is the number of offset days between the news and 4chan data (see fig. 5 ). this cross-correlation score peaks for the number of offset days that results in the maximum overlap of relative coverage scores. for example a of 10 days would imply that information about a specific set of representative actants occurred in the news and 4chan data roughly 10 days apart. captures the latency or periodicity lag between communities mentioned in the news and in 4chan data. the error bars are generated over 20 random communities used for normalizing the coverage scores before cross-correlation. we present standard metrics to further compare communities of actants derived from temporal news reports and social media. our metrics are standard measurements used for clustering evaluations based on ground truth class labels [73]. algorithm 3 describes this evaluation process. we use average recall and average accuracy to evaluate the performance of the phrase-based threat classifier. the average is computed across the fivefold groupshuffled cross-validation of phrases. here, recall and accuracy are defined as, there are limitations with our approach, including those related to data collection, the estimation of the narrative frameworks, the labeling of threats, the validation of the extracted narrative graphs, and the use of the pipeline to support real-time analytics. data derived from social media sources tend to be very noisy, with considerable amounts of spam, extraneous and off-topic conversations, as well as numerous links and images interspersed with meaningful textual data. even with cleaning, a large number of text extractions are marred by spelling, grammatical and punctuation errors, and poor syntax. while these problems are largely addressed by our nlp modules, they produce less accurate entity and relationship extractions for the social media corpus than for the news corpus. also, unlike news articles which tend to be well archived, social media posts, particularly on sites such as 4chan, are unstable, with users frequently deleting or hiding posts. consequently, re-crawling a site can lead to the creation of substantively different target data sets. to address this particular challenge, we provide all of our data as an osf repository [60] . the lack of consistent time stamping across and within social media sites makes determining the dynamics of the narrative frameworks undergirding social media posts difficult. in contrast to the news data harvested from the gdelt project, the social media data are marked by a coarse, and potentially inaccurate, time frame due to inconsistent time stamps or no time stamps whatsoever. comparing a crawl from one day to the next to determine change in the social media forums may help attenuate this problem. given the potential for significant changes due to the deletion of earlier posts, or the move of entire conversations to different platforms, the effectiveness of this type of strategy is greatly reduced. because of the limited availability of consistently time-stamped data, our current comparison between the social media conspiracy theory narrative frameworks, and those appearing in the news, is limited to a three-week window. there appears to be a fairly active interaction between the "twittersphere" and other parts of the social media landscape, particularly facebook. many tweets, for instance, point to discussions on social media and, in particular, on facebook. yet, because of restrictions on access to facebook data for research purposes, we are unable to consider this phenomenon. future work will incorporate tweets that link to rumors and other conspiracy theories in our target social media arena. as part of this integration, we also plan to include considerations of the trustworthiness of various twitter nodes, and the amplification role that "bots" can play in the spread of these stories [16, 23] . as with a great deal of work on social media, there is no clear ground truth against which to evaluate or validate. this problem is particularly apparent in the context of folkloric genres such as rumor, legend and conspiracy theories, as there is no canonical version of any particular story. indeed, since folklore is always a dynamically negotiated process, and predicated on the concept of variation, it is not clear what the ground truth of any of these narratives might be. to address this problem, we consider the narrative frameworks emerging from social media and compare them to those arising in the news media. the validation of our results confirms that our social media graphs are accurate when compared to those derived from news media. currently, our pipeline only works with english language materials. the modular nature of the pipeline, however, allows for the inclusion of language-specific nlp tools, for parsing of languages such as italian or korean, both areas hard hit by the pandemic, and likely to harbor their own rumors and conspiracy theories. in addition, we believe that our semi-supervised approach to threat detection would require less human effort if we had more accurate semantic embeddings. finally, we must note that the social media threads, particularly those on 4chan, are replete with derogatory terms and abhorrent language. while we have not deleted these terms from the corpus, we have, wherever possible, masked those terms in our tables and visualizations, with obvious swears replaced by asterisks, and derogatory terms replaced by "dt" for derogatory term, or "rdt" for racially derogatory term and a qualifier identifying the target group. after running the pipeline and community detection, we find a total of two hundred and twenty-nine communities constituting the various knowledge domains in the social media corpus from which actants and interactant relationships are drawn to create narrative frameworks. many of these communities consist of a very small number of nodes. it is worth noting that several of the communities are "meta-narrative" communities, and focus on aspects of communication in social media (e.g., communities 11 and 74), or platform specific discussions (e.g., communities 44 and 46 that focus on facebook and 181 focusing on youtube and twitter). other communities are "background" communities and focus on news coverage of the pandemic (e.g., communities 7 and 62), the background for the discussion itself (e.g., community 30 that connects the pandemic to death, and community 35 that focuses on hospitals, doctors, and medical equipment such as ventilators), or discussions of conspiracy theories in general (e.g., communities 108 and 109). we find that these "meta-narrative" and "background" communities, after thresholding, tend to be quite small, with an average of 3.9 sub-nodes per community. nevertheless, several of them include sub-nodes with very high ner scores, such as community 155, with only four nodes: "use", "microwave", "hybrid protein" and "cov", all with high ner scores. this community is likely to be included as part of more elaborated conspiracy theory narrative frameworks such as those related to 5g radiation. the five largest communities, in contrast, range in size from 66 to 172 nodes. these five communities, along with several other large communities, form the main reservoir of actants and inter-actant relationships for the creation of conspiracy theory narrative frameworks. we find thirty communities with a node count ≥ 14 . (see fig. 2) . table 2 shows the temporary labels for these communities, which are based on an aggregation of the labels of the three nodes with the highest ner scores and node(s) with the highest-degree. the relationship between the discussions occurring in social media and the reporting on conspiracy theories in the media changed over the course of our study period. in mid to late january, when the corona virus outbreak appeared to be limited to the central chinese city of wuhan, and of little threat to the united states, news media reporting on conspiracy theories had very little connection to reporting on the corona virus outbreak. as the outbreak continued through march 2020, the reporting on conspiracy theories gradually moved closer to the reporting on the broader outbreak. by the middle of april, reporting on the conspiracy theories being discussed in social media, such as those in our research corpus, had moved to a central position (see fig. 3 ). the connection between these two central concepts in the news-"coronavirus" and "conspiracy theory"-can also be seen in the rapid increase in the shared neighbors of these sub-nodes (defined in eq. (1)) in the overall news graph during the period of study (see fig. 4 ). since our dataset contains dated 4chan and gdelt data from march 28, 2020 to april 14, 2020, communities from the social media corpus were explored within the subset of news media between the same dates using relative coverage scores defined in eq. (3). the cross-correlation of the ratio of coverage scores for different fixed communities to a random community is provided in fig. 5 . the higher average scores for the "5g" community including words such as {"5g", "waves", "antenna", "radio", "towers", "radiation"}, suggests that this community was matched more frequently than other communities compared to a baseline random community. a peak at zero days offset within the time period from march 28, 2020 to april 14, 2020 implies that the news reports are correlated in time to 4chan thread activity. in addition, these plots suggest that few communities dominate conspiracy theories more than others. the viability of other communities such as {"army", "us", "bioweapon"} and {"lab", "science", "wuhan"} suggests the lack of a single dominant conspiracy theory consensus narrative. instead, it appears that numerous conspiracy theories may be vying for attention. we examine "bill gates", a key actor frequently found in the common neighbors set between "coronavirus" and "conspiracy theory". key relationships extracted by our pipeline on the news reports provide a qualitative overview of the emergence of "bill gates" as a key actor (see table 5 ). finally, the evaluations based on algorithm 3 are shown in fig. 6 . the plots indicate the saturation of completeness and homogeneity scores at ∼ 92% and ∼ 82% respectively across time. similarly, the v-measure saturates at ∼ 86% . these scores per time sample, represent the fidelity of the process of cluster matching. table 2 the largest thirty communities in the social media corpus in descending order of size the labels are derived from the sub-node labels for the semantically meaningful nodes with the highest ner scores in each community (racially derogatory terms and swears have been skipped). the label of the highest degree node(s) not included in the community label is listed in the third column. nodes with a threat score ≥ 0. 5 the phrase classifier described in the methods was cross-validated and the recall and accuracy across the validation sets are provided in table 3 . recall is used as the primary performance measure in the detection of threats, as the sensitivity to threatening phrases is the most important feature of the classifier. the phrase classifiers applied to descriptive phrases of a particular sub-node provide insight into the context of the sub-node. for the phrase classifier, fig. 8 describes a histogram of the number of sub-nodes across the percentage of associated phrases fig. 2 overview graph of the largest thirty communities in the social media corpus. nodes are colored by community, and sized by ner score. narrative frameworks are drawn from these communities, each of which describes a knowledge domain in the conversation. nodes with multiple community assignments are colored according to their highest ranked community. an overarching narrative framework for a conspiracy theory often aligns subnodes from numerous domains fig. 3 progressive attachment of "coronavirus" to "conspiracy theory" in the co-occurrence network of news reports conditioned on entities found in social media: the orange-outlined nodes represent the two concepts, as they gravitate toward one another over time and form new simple paths. from top to bottom, 5-day intervals starting on january 20, 2020, march 15, 2020, and april 10, 2020. nodes are colored as follows: celebrities in yellow, media outlets in red, important actants in pink (manually colored), places in green and corporations/entities in black classified as threats. table 4 provides a sample set of sub-nodes with their respective threat scores based on the majority vote. a sample sub-node "ccp" has 53% of its associated descriptive phrases classified as threats. the end-to-end classification pipeline, along with sample nearest neighbors during the phrase classification task, is shown in fig. 9 . the lack of authoritative information about the covid-19 pandemic has allowed people to provide numerous, varied explanations for its provenance, its pathology, and both medical and social responses to it. these conversations do not occur in isolation. they not only circulate on and across various social media platforms but also interact with news reporting on the pandemic as it unfolds. similarly, journalists are keenly aware of the discussions occurring in social media, thereby creating a feedback loop between the two. the interlocking computational methods described above facilitate the discovery of a series of important features of the (i) narrative frameworks that bolster conspiracy theories and their constituent rumors circulating fig. 4 number of common neighbors between "coronavirus" and "conspiracy theory" over time in the news reports: across all 101 segments of 5-day intervals, the number of simple paths empirically increases rapidly, suggesting the closer ties between the two entities across time on and across social media, and (ii) the interaction between social media and the news. the main communities and their interconnections in the aggregated social media corpus reveal the centrality of several significant conspiracy theory narrative frameworks. in particular, groupings of large communities form expansive frameworks and may well represent the dominant conspiracy theory frameworks in the corpus. in other cases, coherent narrative frameworks can be discovered within a single community. these communities may have some connections or overlap with communities describing the contours of the pandemic, as well as to other small communities that provide support for aspects of the narrative framework. we find four large community groupings which present easy-to-interpret conspiracy theory frameworks. the first of these groupings is comprised of nodes from communities 5, 56, and 82 (see fig. 7 ). the narrative framework suggests that the corona virus is closely linked to the 5g cellular network, and bill gates's associations with both faulty research and wide-scale vaccination programs. eager to expand a global vaccination program to help prevent the explosion of the world's population, gates has contributed to the design of the corona virus, which can be characterized as a bio-weapon. potentially activated by 5g signals (a technology that is also the result of faulty research), the virus is intended to eradicate various populations throughout the world. certain key sub-nodes play key roles in connecting these communities to create the conspiracy theory narrative. for example, the sub-node "facility, faulty, practice, . coverage percentage is the fraction of actants in news report communities that also are found in social media network communities research" interacts with "bill gates" and his supposed obsession with exploding populations and vaccination efforts, the "virus"' origin story, and the emerging "5g" technology, thereby offering one potential route traversed by conspiracy theorists. this traversal aligns three distinct communities as the conspiracy theorists create fig. 7 communities with index 5, 56 and 82 sequentially describe the conspiracy theory surrounding "bill gates" and "5g". the words in bold are the sub-nodes present in the narrative network and the yellow-highlighted phrases are automatically extracted relationships between the sub-nodes. the blue-highlighted sub-node is a key actant that exists in all 3 communities and is one of the connecting components between "bill gates" and the conspiracy theory around "5g". community 5 describes gates's supposed obsession with population control along with his funding of faulty research. the same research is alleged to have created "5g" as a means of spreading the "virus" which is allegedly intended as a "bioweapon". community 56 takes it a step further tying "5g" to its carrier frequency and the associated interactions of this frequency with the human body. community 82 concludes the origin story of the virus (back to the "faulty" research conducted by "gates") and mentions the cell-level interaction between the virus and the body a unifying theory. none of these key nodes are innocuous, but rather have all been classified as threats (see fig. 10) . a second group is comprised of nodes from communities 1, 40, and 65. in this narrative framework, the limited information about the virus released by the chinese communist party is coupled to the virus's origin either in chinese wet markets selling pangolins, presumably for human consumption, or labs studying bats (or potentially both). the narrative framework is informed by bigoted discussions of chinese food practices coupled to an ongoing critique of the truthfulness of chinese fig. 8 the histogram of threat scores across the sub-nodes from the phrase classifier. the bi-modality encourages binary classification thresholds around 0.2. in our networks, we use 0.25 which is at the 57 th percentile of sub-nodes classified as threats table 4 sample threat scores: note the increasing threat score from the sub-nodes "china" to "chinese" to "chinese, government", which reflects the threat carried by more specific "china" contextualized actants researchers. several intriguing elements of the narrative framework are the "fluoroquinolone" sub-node, an antibiotic which is also a favored medication in other narrative frameworks, and the inclusion of a bill gates sub-node. both of these suggest clear points of potential attachment with other conspiracy theory frameworks, such as the 5g one described above, and another one focused on information cover-ups and the virus-as-hoax (see fig. 11) . a third group, comprised of communities 0, 23, 24, 121 and 150, presents an expansive narrative framework. here, the virus is presented as an engineered bioweapon, either deliberately or accidentally released from a lab. confirmation of the engineered nature of the virus can be provided by scientists (pulmonologists) or members of the military (researcher, soldier). the subnodes in the graph set up a clear dichotomy between western governments and the chinese government, and the controlling chinese communist party (ccp), all of which are classified as threats. it is worth noting that the ccp abbreviation is used by some social media contributors as a reference to the "chinese communist plague", a racially derogatory term for the virus analogous to trump's reference to the virus as the "kung flu" [47] . aspects of the framework also support discussions of the economic impact of the pandemic, as well as the role of "globalists" in promoting the danger of the virus through inaccurate reporting and inflated counts of victims across the world, including europe (see fig. 12) . a fourth grouping comprised of communities 18, 21 and 75, constitutes a narrative framework proposing that the pandemic is a hoax on the same level as the fig. 9 the sub-node "ccp" has associated noun phrases shown in the gray box. the noun phrases have descriptive svcop relationships, whose descriptive phrases are sampled in the light red and green blobs. the phrases in the red blob are classified as threats by our majority classifier and the phrases in the green blob are classified as non-threats. the highlighted and bold descriptive phrases are sample phrases for which the nearest neighbors are shown. the knn classifier reasonably clusters phrases that are syntactically different but semantically similar using the bert embedding. darker nearest neighbors occur more frequently global warming "hoax". this framework includes actants such as trump, the american news commentator sean hannity, the right-wing podcaster nick fuentes and republicans writ large who are fighting against globalists, democrats, scientists such as anthony fauci and, in keeping with the long history of anti-semitism in conspiracy theorizing, the "jews", all of whom have conspired to perpetrate this hoax, which is wreaking havoc on the economy. the british conspiracy theorist, david ickes appears with a direct link to a node representing the "jewish globalists". interestingly, albeit perhaps not surprisingly, bill gates appears once again in this framework, now more closely related to the mueller inquiry and democrats such as obama. while the goal of the hoax is not made explicit, the framework bolster the erroneous suggestion that the virus presents with mild symptoms, and is no more dangerous than the flu (see fig. 13 ). the belief that the pandemic is a hoax inspires the "#filmyourhospital" movement as a means for publicizing the "discovery" that the virus poses no meaningful threat other than the economic threat of stay-at-home orders [31] . several related narrative frameworks intersect with the main "hoax" framework in interesting ways. for example, a grouping of communities 6, 15 and 45, reveals a discussion of the disease, its relation to sars and the flu, the testing regimen, the accuracy of the tests and the efficacy of masks. it also includes an apparent critique of media figures who often endorse conspiracy theories (see fig. 14) . while aspects of this narrative framework can be deployed as part of the more elaborated hoax framework-which seems to be the case particularly given the "threat" coding of "masks"-it can also be activated in the service of a counter-hoax narrative, given the inclusion of anti-conspiratorial content. in that regard, this particular grouping of communities captures the ongoing negotiation of the framework and the activation of parts of a framework as individuals come together (or move apart) to construct a totalizing narrative. there are numerous other nucleations of narrative frameworks in the overall space that are worth noting. a particularly interesting community is 51 which has strong connections to the well-known "pizzagate" conspiracy theory, as well as connections to the much broader qanon conspiracy theory [67] . the intrusion of qanon, and the alignment of the pandemic with the broader narrative of a ring of pedophile human traffickers gained strong support in certain conversations associated with the pandemic-as-hoax frameworks. it also aligns well with the belief, noted above, that tents erected in central park were part of an operation to save children trafficked through underground tunnels, a key feature of the "pizzagate" conspiracy theory [67] . these smaller frameworks suggest that there is a lively, ongoing negotiation of community beliefs about the pandemic. as the conversations progress, many of these smaller narratives are likely to become more closely connected with larger groupings, while others are likely to fade away. community 42, for instance, describes the pandemic as a deliberate attack on the nation perpetrated by the democrats; despite the impact on the global economy, the virus is no worse than a bad flu. such a community could be easily subsumed in the broader virus-ashoax narrative framework. two additional examples of much smaller nucleations would be community 171 which consists of three sub-nodes: "cell phone", "ear" and "state surveillance", and community 123 with six semantically meaningful sub-nodes: "cancer", "cell phone", "cell tower", "microwave", "human cell", and "substance". one would expect, as discussions continue, that these communities would move closer to the 5g conspiracy theory narrative framework. this tendency toward monological thinking already appears to be at work in the alignment of the 5g conspiracy theory with the biological weapons conspiracy theory, with both of those frameworks sharing close connections with the narrative framework describing the pandemic as a whole. other alignments seem possible, with the 5g conspiracy and the hoax conspiracy potentially aligning through community 32, which in general focuses on italy and quarantine measures across europe. the inclusion of two peripheral sub-nodes, one labeled "5g, chemtrailz" and another one that labels the quarantines "ridiculous", not only provide an opportunity to challenge the meaningfulness of quarantine measures (thus providing a potential alignment with the hoax narrative), but also provide a connection between 5g and the longstanding "chemtrailz" conspiracy theory [75] . in earlier work on conspiracy theories, we discovered that conspiracy theorists, as part of their theorizing, tend to collaboratively negotiate a single explanatory fig. 10 a conspiracy theory narrative framework that links the virus to 5g, bill gates, and vaccination. nodes have been scaled by ner mentions; those with fewer than 250 mentions have been filtered for the sake of clarity. nodes are colored by community, and outlined with red if they represent a threat narrative framework, often composed of a pastiche of smaller narratives, aligning otherwise unaligned domains of human interaction as they develop a totalizing narrative [27, 55, 67] . in many conspiracy theories, this coalescence of disparate stories into a single explanatory conspiracy theory relies on the conspiracy theorists' selfreported access to hidden, secret, or otherwise inaccessible information. they then use this information to generate "authoritative" links between disparate domains, engaging in what goertzel has labeled "monological thinking" [27] . for the current pandemic, however, a single unifying corpus of special or secret knowledge does not yet exist-there are no "smoking guns" to which the conspiracy theorists can point, such as the wikileaks emails on which pizzagate conspiracy theorists relied [67] . consequently, the social media space is crowded by a series of conspiracy theories. in the various forums we considered, proponents of different narratives fight for attention, while also trying to align the disparate sets of actants and interactant relationships in a manner that allows for a single narrative framework fig. 11 communities comprising the narrative framework suggesting that the virus is a result of chinese wet markets and deliberate information cover-ups. the narrative framework focuses heavily on markets, exotic animals such as pangolins, and the role of chinese communist party in hiding information about the initial outbreak. nodes are colored by community, and outlined with red if they represent a threat. the graph is filtered to show nodes with degree geq 2 communities comprising the covid-19-as-bioweapon narrative framework. the narrative framework focuses heavily on laboratories and the potential role of the virus as a weapon. nodes are colored by community, and outlined with red if they represent a threat. the graph is filtered to show nodes with degree geq 2 fig. 13 the communities comprising the globalist hoax narrative framework: here, a globalist cabal has conspired to foist the hoax of the corona virus on the world, with the virus presenting with mild flu-like symptoms. trump and his allies are fighting against the democrats and their surrogates to stave off the economic impact of the hoax. nodes are colored by community, and outlined with red if they represent a threat. the graph is filtered to show nodes with degree geq 2. two nodes, "filmyourhospital" and "hoax,see global warming" have been highlighted in yellow to dominate and, by extension, to provide the "winning" theorists with the bragging rights of having uncovered "what is really going on." this type of jockeying for position is also reflected in the news. importantly, there is a lively interaction between the news media and the discussions about the pandemic on social media. consequently, while the news media reports on the conspiracy theories that are evolving on social media, the social media groups point back toward reporting on the pandemic in the news media. the interaction is not, however, one of simple endorsement. rather, the conversations on social media frequently contest, poke holes in, and otherwise challenge the narratives presented in the news media. in turn, the news media explores not only the content but also the veracity (or lack thereof) of the social media discussions. unlike normal fact checking, however, the rejection in the news media of a particular social media position may be fuel for the conspiracy theorists, given their frequent suspicion of the news media. this interaction between social media and the news, modeled by the cross-correlation of relative coverage scores in fig. 5 , indicates that the information flow fig. 14 a narrative framework that can be deployed by multiple groups. the framework focuses on the relationship between the virus, sars, the flu and the testing regimen. also included are nodes representing research on the virus and questions of immunity. a small disconnected component on the filtered graph provides a critique of qanon and glenn beck. nodes are colored by community, and outlined with red if they represent a threat. the graph is filtered to show nodes with degree geq 2 between the two corpora is swift: the correlation-maximizing offset of days was 0 or nearly 0 for all considered actant groups. since the data is smoothed over five days, this finding implies that the major actants appearing in narrative frameworks get aligned within days of appearing in either channel. a qualitative example expanding upon this dynamic of knowledge synchronization between the news and social media is observed in table 5 where "bill gates" was earlier highlighted as an important actant. news reports on april 4 actively mentioned gates's prediction of the covid-19 outbreak. at the same time, 4chan threads were embroiled in the discussion of "5g" causing the "coronavirus". perhaps the shock of such an accurate prediction--and bill gates's continued investment in pandemic prevention and vaccine research--helped motivate david icke, an influential conspiracy theorist, to proclaim on april 7 that "bill gates belongs in jail", echoing comments of a florida pastor, adam fannin, who believes gates is involved in a global effort to depopulate the world. in the ensuing days after ickes's comments, 4chan threads began denigrating "gates", alleging him to be a part of a satanic cabal (thereby creating a direct link to "pizzagate"), labeling him the anti-christ, and accusing him of being an opportunist forcing the world into a crisis to further his alleged forced vaccination campaign. news reports, seemingly in response, summarized the conspiracy theories circulating on 4chan communities with headlines such as, "the dangerous coronavirus conspiracy theories targeting 5g technology, bill gates, and a world of fear" [65] . as the global covid-19 pandemic continues to challenge societies across the globe, and as access to accurate information both about the virus itself and what lies in store for our communities continues to be limited, the generation of rumors and conspiracy theories will continue unabated. although news media have paid considerable attention to the well-known q-anon conspiracy theory (perhaps the most capacious of conspiracy theories of the trump presidency), social media conversations have focused on four main conspiracy theories: (i) the virus as related to the 5g network, and bill gates's role in a global vaccination project aimed at limiting population growth; (ii) a cover-up perpetrated by the chinese communist party after the virus leaped to human populations based largely on chinese culinary practices; (iii) the release, either accidental or deliberate of the virus from, alternately, a chinese laboratory or an unspecified military laboratory, and its role as a bio-weapon; and (iv) the perpetration of a hoax by a globalist cabal in which the virus is no more dangerous than a mild flu or the common cold. as the conversations evolve, these conspiracy theories appear to be connecting to one another, and may eventually form a single coherent conspiracy theory that encompasses all of these actants and their relationships. at the same time, smaller nucleations of emerging conspiracy theories can be seen in the overall social media narrative framework graph. because the news cycle appears to chase social media conversations, before feeding back into it, there is a pressing need for systems that can help monitor the emergence of conspiracy theories as well as rumors that might presage real-world action. we have already seen people damage 5g infrastructure, assault people of asian heritage, deliberately violate public health directives, and ingest home remedies, all in reaction to the various rumors and conspiracy theories active in social media and the news. we have shown that a pipeline of interlocking computational methods, based on sound narrative theory, can provide a clear overview of the underlying generative frameworks for these narratives. recognizing the structure of these narratives as they emerge on social media can assist not only in fact checking but also in averting potentially catastrophic actions. deployed properly, these methods may also be able to help counteract various dangerously fictitious narratives from gaining a foothold in social media and the news. at the very least, our methods can help to identify the emergence and connection of these complex, totalizing narratives that have, in the past, led to profoundly destructive actions. covid-19 and the 5g conspiracy theory: social network analysis of twitter data flair: an easy-to-use framework for state-of-the-art nlp the psychology of rumor a resistant strain: revealing the online grassroots rise of the antivaccination movement becoming a nazi: a model for narrative networks science vs conspiracy: collective narratives in the age of misinformation six zombie claims about the coronavirus that just won't go away fast unfolding of communities in large networks pandemic populism: facebook pages of alternative news media and the corona crisis-a computational content analysis an investigation of the laws of thought: on which are founded the mathematical theories of logic and probabilities network 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consequences the conspiracy theory handbook data mining and content analysis of the chinese social media platform weibo during the early covid-19 outbreak: retrospective observational infoveillance study legends of hurricane katrina: the right to be wrong, survivor-to-survivor storytelling, and healing hdbscan: hierarchical density based clustering the infamous# pizzagate conspiracy theory: insight from a twitter-trails investigation graphing the grammar of motives in national security strategies: cultural interpretation, automated text analysis and the drama of global politics trump sparks backlash over racist language -and a rallying cry for supporters conspiracy theories and the paranoid style (s) of mass opinion oral repertoire and world view. an anthropological study of marina takalo's life history the morphology of the folktale clustype: effective entity recognition and typing by relation phrase-based clustering v-measure: a conditional entropy-based external cluster evaluation measure rumor and gossip: the social psychology of hearsay psychology of rumor reconsidered conspiracies online: user discussions in a conspiracy community following dramatic events the government spies using our webcams' the language of conspiracy theories in online discussions how false hope spread about hydroxychloroquine to treat covid-19 -and the consequences that followed go eat a bat an automated pipeline for character and relationship extraction from readers literary book reviews on goodreads covid-19\_conspiracy-theories improvised news: a sociological study of rumor. ardent media interpreting oral narrative. folklore fellows oligrapher naturally, we now have a cottage industry of coronavirus truther assholes. the daily beast the dangerous coronavirus conspiracy theories targeting 5g technology, bill gates, and a world of fear rumors, false flags, and digital vigilantes: misinformation on twitter after the 2013 boston marathon bombing. iconference 2014 proceedings an automated pipeline for the discovery of conspiracy and conspiracy theory narrative frameworks: bridgegate, pizzagate and storytelling on the web toward a generative model of legend: pizzas, bridges, vaccines, and witches mommy blogs" and the vaccination exemption narrative: results from a machine-learning approach for story aggregation on parenting social media sites satanic panic: the creation of a contemporary legend on the spread of tradition fearing coronavirus, arizona man dies after taking a form of chloroquine used to treat aquariums prevalence of low-credibility information on twitter during the covid-19 outbreak conspiracy theories and the paranoid style (s) of mass opinion publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations key: cord-280981-p0l5bpqi authors: keenan, jesse m. title: covid, resilience, and the built environment date: 2020-05-14 journal: environ syst decis doi: 10.1007/s10669-020-09773-0 sha: doc_id: 280981 cord_uid: p0l5bpqi this article provides a perspective on the reciprocal relationships between public and private sector resilience planning activities and the ongoing covid responses in the u.s. through the lens of the built environment, this article provides selected insights into how various disaster, organizational, and engineering resilience activities have likely positively shaped covid responses within the healthcare sector. these positive influences are contextualized within extensive efforts within public health and healthcare management to calibrate community resilience frameworks and practices for utilization in everything from advancing community health to the continuity of facilities operations. thereafter, the article shifts focus to speculate on how ongoing experiences under covid might yield positive impacts for future resilience designs, plans and policies within housing and the built environment. through this perspective, the article hopes to explore those often overlooked aspects of the physical and social parameters of the built environment that may be understood as providing opportunities to inform future disaster, public health, and climate change preparations and responses. climate change and the novel coronavirus ("covid") have much in common. like climate change, the covid pandemic was widely anticipated among public health officials and medical scientists for decades (kleinman and watson 2006; yang et al. 2020 ). among climate change experts, the risks of infectious disease and pandemics have long been on the list of multi-hazards to anticipate (semenza and menne 2009) and to observe (caminade et al. 2019) . indeed, some of the planning associated with the next anticipated coronavirus pandemic has laid the foundation for ongoing treatment and vaccine advancements being made on a near weekly basis. yet, for the most part, the risks from any number of potential-and even likely-pandemics have been broadly ignored by the general public and policy makers for decades-despite the science, despite the warnings. there is nothing new here-it's the same old story from precautionary principles (or lack thereof) to the behavioral and cognitive limitations to risk assessment and prioritization (sunstein 2006) . in this regard, covid and climate change are societal outcasts too ugly to standout and too deadly to ignore. yet, in our responses to both, they share a common linkage that offers an opportunity to reflect on where we have been and we are going within the allied fields of resilience and adaptation. this article provides a perspective on the reciprocal relationships between public and private sector resilience planning activities and the ongoing covid responses in the u.s. through the lens of the built environment, this article provides selected insights into how various disaster, organizational, and engineering resilience activities have likely positively shaped covid responses within the healthcare sector. these positive influences are contextualized within extensive efforts within public health and healthcare management to calibrate community resilience frameworks and practices for utilization in everything from advancing community health to the continuity of facilities operations. thereafter, the article shifts focus to speculate on how ongoing experiences under covid might yield positive impacts for future resilience designs, plans and policies within housing and the built environment. through this perspective, the article hopes to explore those often overlooked aspects of the physical and social parameters of the built environment that may be understood as providing opportunities to inform future disaster, public health, and climate change preparations and responses. there a number of primary categories associated with different variants of resilience that have their own independent conceptual and analytical frameworks-there is no one type of 'resilience' (davidson et al. 2016; moser et al. 2019 ). among the categorical variants of resilience, it is 'disaster' and 'engineering' resilience that are most widely utilized in domestic multi-hazard and climate change planning in the u.s. (keenan 2018) . within these planning activities there is increasing sophistication in separating 'risk' and 'resilience' as independent, but related, domains of management and policy (linkov et al. 2018a, b) . while there is not a uniform consensus across fields of scholarship and practice, as a general matter, risk is relegated to responding and preparing (i.e., mitigation, transfer, etc.,) for known phenomena based on a relatively stationary probabilistic outcomes, and resilience is primarily oriented to capacities that address both known and unknown phenomena representing a broad spectrum of probability and uncertainty in comparatively fluid and dynamic conditions and responses (linkov et al. 2018a, b) . in this sense, resilience is critically important for filling the void left by risk management that is limited to probability-particularly as it relates to low probability or highly uncertain, high impact events such as covid. in its most simplified distillation, 'engineering' resilience (and to a large extent 'disaster' resilience) speaks to the elastic and reversionary capacities of a system to return to pre-stimulus level of operational performance and material quality, which may ultimately lead to adaptive and maladaptive outcomes depending on aging effects and the associated costs of time and money in supporting such performance (hosseini et al. 2016; kurth et al. 2019) . engineering resilience is descriptive and may be readily designed and observed in a variety of engineered systems, including a variety of infrastructure systems and sectors (bostick et al. 2018 ). on the other end of the spectrum of categorical resilience is 'community' resilience, which speaks to the capacity of communities-a collection of individuals and among social organizations-to respond, recover and accommodate external shocks and stresses (matarrita-cascante et al. 2017) . by contrast to engineering resilience, the measurement of community resilience is still at an early-stage (sharifi 2016; cutter 2016 ) and current practices in community resilience at largely normative in favor of subject judgements about how communities ought to prepare for and respond to ongoing challenges (patel et al. 2017) . although there are other important categories, such as 'ecological' and 'organizational' resilience, engineering and community resilience have been the primary drivers in u.s. resilience planning activities in the built environment in the past decade. while advancements in the framing and measurement of community resilience have been popular in the literature as a free-standing largely normative exercise, in practice, much of this work has operated to provide a social and human dimension to the operations of disaster and engineering resilience among emergency management institutions (nist 2015; koliou et al. 2017) . while there are known limitations to emergency management's ability to challenge structural institutions that define long-term vulnerabilities to climate change (gillard 2016) , covid is the type of shock that fits within emergency management's multi-hazard framework (djalante et al. 2020 ). in the past decade, multi-hazard disaster and engineering resilience planning has had significant impacts in shaping the design and management of the built environment in everything from supporting the business continuity of private enterprise (keenan 2015) to the sustainable provision of critical public services (humphries 2019) . over the past decade, public health officials have actively participated in the diffusion of disaster and community resilience planning practices alongside their colleagues in emergency management, urban planning, and civil engineering. mass casualty preparations in recent years in the u.s. have largely centered on gun violence under a different policy regime within homeland security in the age of terrorism and mass shootings (melmer et al. 2019 ). however, disaster resilience planning activities have more broadly engaged both public and private health systems to look inward in terms of internal communications and business continuity; critical facilities and operations assessments; and multi-network contingency planning (zhong et al. 2014; verheul and dückers 2020) . the urgency of this work was well amplified with the high-profile loss and evacuation of nyu langone medical center in new york city during hurricane sandy in 2012-a major center of healthcare for much of manhattan (powell et al. 2012; seltenrich 2018) . in the years that followed, healthcare systems from across the country have been actively preparing for a variety of hazards, including those associated with climate change impacts (uscrt 2016). by the time hurricane harvey hit houston in 2017, the sector had a new champion in the texas medical center, which has served as the quintessential case study for engineering and operational resilience capacities (flynn 2018) . it is worth recognizing that the motivation for such resilience investments is partially driven by the potential for superior health outcomes, but it is also a function of the economic losses that resonate well beyond facilities repair and replacement (desai et al. 2019 ). engineering resilience models and techniques have informed nearly every aspect of facilities design and management from dry flood proofing of critical equipment (chand and loosemore 2016a, b; bignami et al. 2019 ) to real-time intelligence of surface transportation for managing vehicle traffic (tariverdi et al. 2019) . beyond facilities, healthcare firms have also benefited from organizational resilience efforts to prepare for alternative supply chains and procurements models (mandal 2017) . but, disaster resilience 'thinking' also forced hospital and healthcare networks to evaluate the adaptive capacity of their building designs to handle multiple types of programs and alternative configurations (aghapour et al. 2019) . we see the benefits of this today with the expansion of intensive care units ("icu") into other parts of hospital facilities, as well as the coordination between in-hospital care and the utilization of portable mass care facilities. by another measure, the rapid deployment of telemedicine may very well challenge the future utility of some medical facilities, even if that ultimately means something like smaller waiting rooms in family practice offices (aldossary et al. 2017 ). in the broader national effort to cut healthcare costs, every square foot counts. in addition, as healthcare networks have expanded into a hub and spoke model for outpatient care, these outpatient facilities have turned into what used to be the purpose of neighborhood public health facilities-they have become, in some cases, a critical access points for covid testing and triaging (elrod and fortenberry 2017) . in some cases, a cvs pharmacy is doing what a county public health facility used to do (repko 2020) . while a replacement of public health facilities with private healthcare facilities is not a particularly defensible model, this ad hoc utilization amplifies the proposition of several u.s. cities, including miami, for the development of local 'resilience hubs' that can serve as a physical platform for deploying public health, food, information and other resources for communities in good times and in bad (city of miami 2020). unfortunately, such 'hubs' are not currently considered critical facilities under u.s. department of homeland security ("dhs") rules and are therefore ineligible for funding under a number of programs. perhaps moving forward, reinvestment in community public health facilities through dhs programs could serve a variety of public health and disaster and community resilience co-benefits. indeed, public health scholars and practitioners have made considerable advances in operationalizing community resilience. in a post-cutter landscape of indeterminate quantitative socioeconomic resilience indicators (burton 2015) that are limited in their replicability and scalability within existing policy pathways (cutter and derakhshan 2019), public health has stepped-up to advance a mix of quantitative and qualitative community resilience indicators that tell a broader story of community health that is central to our physical and mental capacity to endure climate change and other public health crises (who 2018). indeed, public health has squarely captured the attention of public policy makers by arguing that community resilience is central to offsetting existing inequitable disparities in accessing the u.s. healthcare system (lichtveld 2018) . but, these advancements have come in all sorts of shapes and sizes. at a truly community scale, there is little doubt that community gardens started by public health and civic ecology advocates in the name of community resilience will be providing fresh, healthy food for families struggling with covid this summer (shimpo et al. 2019) . perhaps community gardens and resilience hubs should both be added to the dhs critical facilities list-along with pharmacies, grocery stores and other facilities that are truly critical for social welfare and life-safety. aside from an expanded list of critical facilities, the covid crisis offers insights into a variety of vulnerabilities, coping strategies, and an ad hoc interventions that offer insight into future resilience planning and design activities. it is widely acknowledge that resilience is generally advanced in institutional terms each time that a government or a community has an experience with a disaster-there is always something to be learned (young 2010; henly-shepard et al. 2015) . another recent disaster-the foreclosure crisis (2008-2011) during the great recession-led to a number of legislative reforms that identified financial risks at the household level and across the housing financing system. these reforms sought to mitigate and manage a variety of risks that are yielding benefits today. one could argue that they have advanced the specific resilience of the housing economy. beyond risk transfer mechanisms in the capital markets and the elimination of highly risky loans, banks and mortgage servicers are much more reluctant to foreclosure recognizing that the weight of the empirical evidence suggests that alternative work-outs are far more effective in maintaining the asset value of mortgages and housing collateral. whether it is loan forbearance or debt reduction, these lessons have since helped local housing markets stabilize following countless hurricanes and forest fires in the past decade (gallagher and hartley 2017) . in the coming years, we will likely also have a much better sense of what works and what does not work in light of current congressionally allocated emergency subsidies and their effect in stabilizing local economies and housing markets. in particular, we are currently undergoing the most widespread set of experiments in rental housing stabilization every undertaken and the lessons from this will likely shape future resilience and post-disaster recovery efforts that engage housing stabilization for generations to come. so, the question remains: what are we learning about our use and design of the built environment today in the midst of the covid crisis that might shape future resilience efforts? the intimacy of social isolation has afforded us the luxury of seeing and experiencing our built environment in a very different way. from the lower occupancy rates of grocery stores to the social spaces partitioned within even a single room, there is much to be explored. most immediately, building managers are actively developing infectious disease control protocols for operating and cleaning buildings. they are thinking about weak links in hvac systems, filtration standards, and the prospects for transmission in common areas (nmhc 2020). these emerging practices are also likely to advance greater attentiveness to indoor air quality as people spend significantly more time inside than usual. other adaptations are perhaps less applicable, such as new signage requiring single occupancy elevator rides. yet, other mundane challenges associated with providing access to quarters for coin operated laundry serving tens of millions of american renters may be a key preparation in the future. while resilience techniques for multi-family buildings are comparatively mature, additional operational and performance standards are likely to originate from covid (schoeman 2015) . the design of residential housing is a reflection of our cultural construction of home and its domestic attributes. the domestic realities-good and bad-are compressed in time and spaces over the course of disasters. what happens when long periods of isolation leads to domestic violence? perhaps a resilience standard might require the installation of locks on interior doors. ensuring safe spaces might actually require the design of safe spaces. the intimacy of social relationships also plays out for families who are remotely working in spaces designed almost exclusively for entertainment, leisure and domestic pursuits. this requires new forms of multi-purpose furniture and adaptive swing spaces where eating, working and study spaces overlap. while consumer design preferences are unlikely to overcorrect to the covid experience, there are subtle adaptations that are likely to be positive. people are more sensitive to storage and their overall consumption. they are finding ways to recycle materials and fix things that they might have otherwise simply replaced. this economization of material speaks to social learning that is likely to have a positive impact on the resilience of the built environment when the next disaster strikes. just in terms of disaster preparedness, many families will now not only have stockpiles of food and medicine, they will also have things like home medical diagnostic equipment (e.g., iphone compatible portables ekg devices) and home school education materials. all of these preparations are critically important, especially at a time when covid is significantly weakening our national emergency response capacities for hurricanes, floods, forest fires and other labor intensive disasters. beyond the household, the novel experiences with the built environment are extending into streetscapes, parks and other forms of public space. times of disaster do intensify out biophilic behaviors, but they also highlight the fundamental values associated with investments in public space and the natural environment (tidball 2012) . with many fewer cars on the streets, a new civic realm may be envisioned that supports a more sustainable worldview of the built environment, including what it means to have a reduction in health impacts associated with air pollution (dutheil et al. 2020) . these renewed landscapes are the grounds where people are mobilizing new commitments for physical exercise-once speculated to be a major indicator of community resilience by the u.s. government (fema 2016) . like new year's resolutions, these behaviors are likely to fade in a post-covid recovery. yet, they offer valuable insight into where priorities for resilience should be defined and the role that the built environment plays in supporting those priorities. learning from disasters is critical. in the heat of the moment, we have the opportunity to observe what is working and what is not working-and for whom. as this article has highlights, existing covid responses have likely benefited from recent resilience planning efforts largely advanced in the name of addressing climate change and disaster mitigation. in particular, public health and healthcare management contributions to a broader interdisciplinary field of inquiry associated with community resilience have likely translated into meaningful action that could very well reciprocally advance resilience activities in other sectors. specific to the healthcare sector, considerations relating to the resilience and adaptive capacity of the built environment are central to managing of the existing challenges associated with supply constraints, alternative forms of service delivery, and the broader continuity of operations. in the linkage between prior disaster experience-some of which are attributable to climate change impacts-and covid, we find a measure of maturity in the human health and healthcare sectors that provides hope for the progressive development of core practices and strategies associated with disaster, organizational and engineering resilience. the covid experience has also imposed new perspectives on the role housing and the built environment in shaping resilience interventions and capacities as viewed through the lens of domiciliaries, consumers, and civic actors. from the management of social space to disaster preparedness, the built form is a conduit for shaping positive behaviors that are the heart of any frame for community resilience. while some ad hoc covid responses will soon fade, others will sustain as part of our collective adaptive capacity for addressing future social and environmental shocks and stresses. in these times of crisis, it is worth recognizing that the future of research and practice across various domain of resilience and adaptation will be defined not only by the quantifications of socioeconomic indicators but also by the qualification of the human experience in all its capacities for ingenuity, empathy, and moral responsibility. whether it is the advancement of human health or the design of architecture and the built environment, we are reminded that learned resilience is a uniquely human endeavor. capacity planning and reconfiguration for disaster-resilient health infrastructure a systematic review of the methodologies used to evaluate telemedicine service initiatives in hospital facilities flood proofing in urban areas resilience science, policy and investment for civil 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atmospheric administration defining and operationalizing disaster preparedness in hospitals: a systematic literature review who health evidence network synthesis report: what quantitative and qualitative methods have been developed to measure health-related community resilience at a national and local level. world health organization the deadly coronaviruses: the 2003 sars pandemic and the 2020 novel coronavirus epidemic in china institutional dynamics: resilience, vulnerability and adaptation in environmental and resource regimes validation of a framework for measuring hospital disaster resilience using factor analysis key: cord-025248-6e05mgy8 authors: lewis, judy l. title: the usa’s modern civil rights movement and basic income guarantee date: 2020-05-27 journal: political activism and basic income guarantee doi: 10.1007/978-3-030-43904-0_7 sha: doc_id: 25248 cord_uid: 6e05mgy8 this chapter explores dr. martin luther king jr.’s (mlk) contribution to basic income guarantee (big) and its association with the usa’s modern civil rights movement (mcrm). the exploration begins with a synopsis of the mcrm: its antecedents, a biographical sketch of mlk and a precis of his leadership. a discussion of mlk’s support of big and a brief survey of his long-term influence follow, ending with the conclusion. the goal is to identify and analyze the international thought-leader, nobel peace laureate and civil rights strategist’s approach (justifications and strategies) to realizing big for practical and theoretical lessons that could inform future and current big activism. battle for the radical republican minority, who wanted a comprehensive reconstruction of the southern states that supported the rights and well-being of both races (encyclopedia britannica, n.d.c) . unfortunately, the resolution of the disputed 1876 presidential election eroded the radical republican minority's party-influence as well as their political and military power in the south (encyclopedia britannica, n.d.c) . during this period, the newly emancipated blacks formed coalitions with poor whites in the south and whites in the north on a mandate to undo the effects of slavery. by 1868, they won enough seats to control all southern statehouses and passed constitutions that "denounced and made slavery unconstitutional," "included labor rights," "fought for health care," provided education, extended voting access, "established fairness in the criminal justice system," and raised taxes to fund these programs (barber 2018) . this was met with resistance from the redemption movement starting in 1872. the group used voting manipulations, lowering of taxes and physical violence to undermine the progress made by the interracial coalition (barber 2018 ). the post-1876 passage of jim crow laws effected a de facto southern repeal of the 14th and 15th amendments. 1 in the northern states, inequality was still institutionalized, but less overtly. even so, black americans found ways to succeed, creating institutions, communities and stable families. by the 1900s, black and white americans' abolitionist energy had transformed into a nascent civil rights movement that strengthened over the next half of a century. the national association for the advancement of colored people (naacp) was founded in 1909 by an interracial group after vicious race riots in springfield illinois; w. e. b du bois, whose 1905 niagara movement was an inspiration, was the only black executive member (naacp, n.d.a). headquartered in new york city, the naacp utilized legislation and publicity to effect change. the national urban league was founded in 1910 (national urban league, n.d.). the new negro movement, which was a multi-aspect re-imagination of the black identity influenced by black americans' experience in world war i, included the harlem renaissance and saw the rise of leaders with a range of ideologies. these leaders included marcus garvey of the universal negro improvement association and a philip randolph of the brotherhood of sleeping car porter (cunningham 1996) . the second decade of the twentieth century also saw the first wave of the great migration of southern black americans seeking to escape segregation and its economic limitations by moving north (encyclopedia britannica, n.d.b) . founded in 1942, congress of racial equality was an interracial organization that embraced direct-action projects and mohandas k. gandhi's 2 nonviolence to end segregation and improve race relations (encyclopedia britannica, n.d.a). world war ii sparked black activism both during and afterward. a philip randolph and the naacp's plan for a march on washington dc induced president f. d. roosevelt (1941) to issue an executive order opening defense jobs to people of all races (clayborne, n.d.; naacp, n.d.a.) . president roosevelt also established the fair employment practices committee to ensure adherence to the executive order (naacp, n.d.a) . inspired by the experience of equality aboard and angered by the discrimination within the armed forces, veterans added a new vigor to the civil rights movement; medgar evers, active in the regional council of negro leadership (founded 1951) and the naacp, was a veteran (clayborne, n.d.; naacp, n.d.b; ownby 2018) . the naacp's brown v. board of education (1954) lawsuit led by civil rights lawyer thurgood marshall resulted in the supreme court's ruling that separate education is not equal. this victory overturned the 1896 supreme court plessy v. ferguson decision, whose "separate but equal" had "ratified" jim crow laws (clayborne, n.d.; naacp, n.d.a) . born michael king jr. in atlanta, georgia (1929) , and renamed martin luther king jr. aged five after his father's life-and-name-changing trip to germany (brown 2019) , mlk was as much influenced by his own racial experiences as by his mother's affirmation of his personhood and his father's personal and ministerial resistance to segregation (king 1998 ). the peaceful race relations mlk experienced in the northern state of connecticut the summer before entering morehouse college, georgia, had a great impact on the fifteen year old (king 1998) . at morehouse, mlk was encouraged to seek a positive solution to racism, discovered henry david thoreau and eventually followed his father, grandfather and great grandfather into ministry (king 1998 ). an early mentor was morehouse's president benjamin mays, who prioritized action for gospelinspired social justice (lewis and clayborne 2019) . mlk continued his studies at crozer theological seminary, pennsylvania. here, he sought a means to end social ills by reading major social and ethical philosophers, encountered and deeply explored gandhi's nonviolent approach to social change, was elected president of the predominantly white student body, further honed his oratory skills and graduated valedictorian (king 1998; lewis and clayborne 2019) . formal studies culminated at boston university with a doctorate in systematic theology at age 26. mlk and coretta scott of alabama, who was studying at the new england conservatory of music and already a civil rights activist, met in boston and married; thus, the choice to begin his career in the south and as a pastor was a thoughtful, well-discussed decision made by both, fully aware of the sacrifices and responsibilities they were accepting (king 1998) . he was at dexter avenue baptist church in montgomery alabama fifteen months with a very young family when jo ann robinson and the women's political council championed rosa park's refusal to give up her seat on the bus to a white man (king 1998 ). this decision mushroomed into a clergy supported movement that saw mlk, who was a member of the alabama council on human relations and the local naacp chapter, elected as the inaugural president of the montgomery improvement association (mia) (king 1998 ). mlk's reflections on the public's debate of the bus boycott led him to conceptualize the campaign as a nonviolent choice to not cooperate with an evil structure (king 1998) . he also realized that "christ furnished the spirit and motivation while gandhi furnished the method" (king 1998, 67) . up to that point, mlk had struggled with how love could be a transformative force socially as well as interpersonally (king 1998) . during this campaign, he worked out his principles for nonviolent living 3 as presented in his first book "stride towards freedom : the montgomery story" (1958, 90-95) . this book is a reflection on the year-long bus boycott campaign that claimed victory on november 13, 1956, when the supreme court (browder v. gavie) ruled bus segregation in montgomery and alabama unconstitutional. mlk was elected president of what would come to be known as the southern christian leadership conference (sclc) in january 1957 by close to 100 southern civil rights leaders (king 1967a ). this new organization provided leadership for civil rights organizations across the south, and recognizing the nation would not be whole until black americans were completely free, took as its motto: "to save the soul of america" (king 1967a (king , 1998 . he held this office until his assassination on april 4, 1968. his leadership included direct actions 4 to the point of arrests. mlk's 1963 "letter from a birmingham jail" responded to several interfaith leaders who urged patience in the work to end racial segregation. it documents the core of his 6-point methodology for nonviolent social change 5 (king 1986b, 290) . as the direct actions, speeches, books, articles, media appearances, sermons and leadership work continued mlk's stature grew nationally and internationally. he traveled to ghana and india where he met with national leaders; vice president nixon, presidents eisenhower, kennedy and johnson consulted with him (king institute, n.d.) . mlk was awarded the nobel peace prize in 1964 and selected time magazine man of the year in january 1964. at the 1963 march on washington for jobs and freedom, mlk gave his "i have a dream" speech. he was present when president johnson signed the civil rights act of 1964 that outlawed jim crow laws and put measures in place to prevent discrimination in public and work environment (king 1986c ). the voter's rights act was passed in 1965. however, in the opening chapters of "where do we go from here: chaos or community?" (1986c), mlk recognized the need for a second phase to the civil rights work and grappled with the splintering of the nonviolent movement as continued resistance to legislative civil rights victories gave rise to black power terminology and ideology. mlk also noted that the major legislative victories did not impact most black americans' everyday quality of life. this post-1965 period deepened mlk's understanding of racism's foundations/nature and what needed to be done to realize love's force to transform society-hence, his public denouncement of the vietnam war and his emphasis on the economic aspect of civil rights, that was part of his consciousness even before he entered morehouse college (king 1998) . economic aspects came to the fore with the poor people's campaign (ppc). in an address to the sclc eleventh annual convention, mlk identified the need to work for "a guaranteed annual income" in the context of "restructuring the whole of american society" to address the interrelated "triple evils" of "racism," "economic exploitation" and "war" (1967b). he also contrasted economist john kenneth galbraith's identification of an annual cost of $20 billion for a guaranteed annual income program with the annual $55 billion spent on the vietnam war and the moon landing program. he also maintained that implementing big would eliminate other social ills. in mlk's work, the larger goals were america's actualization of the promise enshrined in the constitution and the incarnation of the beloved community, later the world house, where human laws match divine laws, where all peoples live together in peace and justice and where humanity's innate dignity is recognized (king center, n.d.; king 1964 king , 1967a king , 1986a . thus, humankind's potential to embody love and to live at the highest moral level would be fulfilled. this means mlk justified big in terms of patriotism, national self-actualization, a condition for peace and justice, the dignity of the human person and humankind's selfrealization. therefore, his support of big was not a stand-alone issue and ultimately sought to benefit all peoples everywhere. further, in classic kingian style, it was the fruit of deep thought, a maturation of his nonviolent philosophy, and documented in "where do we go from here: chaos or community?" mlk (king 1986c ) recommended a guaranteed income for those who could not work and a guarantee of meaningful jobs with a guaranteed income for everyone else. he also recommended a dynamic income level tied to the median income. the call for a guaranteed annual income structured as a regular unconditional means-tested payment or as wage for meaningful jobs remained throughout the poor people's campaign (ppc) and was documented in the first two demands of the campaign's social and economic bill of rights (chase 1998; jackson 2007; poverty initiative 2012) . thus, mlk proposed a modified big as it lacked some of the five essential elements identified in basic income earth network's (n.d.b) detailed definition of "a periodic cash payment unconditionally delivered to all on an individual basis, without means-test or work requirement." the december 4, 1967 press conference announcement of the ppc launched political activism (chase 1998 ; poverty initiative 2012). the ppc was conceived to be three-phased (chase 1998 ; poverty initiative 2012). phase one was to be the building of a shanty town (resurrection city) to house up to three thousand poor persons in a very visible location in washington, d.c. and the holding of daily demonstrations. phase two was to consist of large-scale arrests across the capital in the context of demonstrations and marches meant to further awaken the government and the public to the reality of american poverty. phase three was to be a nationwide boycott of shopping areas and the country's most powerful corporations until stakeholders forced congress to enact the social and economic bill of rights. in preparation for phase one, mlk traveled across the country mobilizing local groups to join the national movement, seeking funding, inspiring poor communities and establishing alliances with multiracial poor 6 activist organizations across issues, with labor unions and with other groups; this included a march 1968 gathering of fifty multiethnic organizations 7 (chase 1998; jackson 2007; poverty initiative 2012) . in march 1968, mlk decided to support the memphis sanitation workers' strike against the city, even after there was violence, realizing the importance of building local groups and their direct actions while simultaneously preparing for the national ppc (king 1998) . his assassination during this time meant leadership passed to rev ralph abernathy, vice president of sclc. dr. abernathy redirected the campaign to consist of a modified phase one only that was meant to endure until the bill of rights was enacted (poverty initiative 2012). on april 29, 1968, delegates gathered in washington dc to lobby federal agencies before dispersing to dispatch nine caravans of the diverse poor people coalition that journeyed from the ends of the country to washington dc, growing in size as they got closer; the first arrived on may 12, 1968 (jackson 2007; poverty initiative 2012) . construction of resurrection city began the following day and lobbying resumed (jackson 2007 ; poverty initiative 2012). the solidarity day rally for jobs, peace and freedom on june 19, 1968, was the only mass action and brought fifty thousand supporters (jackson 2007 ; poverty initiative 2012). on june 24, after the initial and renewed permits expired, residents of resurrection city were forced to leave by police dressed in riot gear; resurrection city, which was on the national mall between the lincoln and washington memorials, was subsequently bulldozed (poverty initiative 2012). the press, some labor unions, the political powers-brokers and the fbi were against the campaign, with the fbi acting to sabotage it (chase 1998; jackson 2007; poverty initiative 2012) . jackson (2007) documents alarmed white americans writing to president johnson asking for the campaign to be stopped and that the president wavered between indifference, appeasement and preparations for violence during the resurrection city era lobbying efforts. a june 10, 1968, washington post article reported a national survey which found that while eighty percent of blacks supported the ppc (and only eleven percent opposed it), only twenty-nine percent of whites backed the campaign and sixty-nine percent rejected it (chase 1998) . this analysis will focus on four areas: response within the modern civil rights movement (mcrm), response from the rest of the usa, political activism events and mlk's thought and methodologies. mlk was a theologian, philosopher and an ordained minister, who identified the interrelated triple evils of poverty, racism and militarism empirically when he realized the vietnam war was debilitating president johnson's war on poverty (king 1986c) . thus, he considered his evolution to including economic inequality in the work to end the adverse effects of racism as a turn to human rights. however, harman (2017), a historian, formulated a view of the origination of the triple evils that reveals economic rights are civil rights. harman argues that class society developed when humankind transitioned from roving hunter-gatherer communities to become settled producers who developed large-scale production. in the former arrangement, the hunters provided meat, which was a treat, and the gatherers provided the staples. both groups needed and valued each other. in the newer large-scale arrangement, the managers of the resultant surplus, who were also the planners of production, began to think their contribution was more important even as they recognized their dependence on those who actually produced the surplus. harman holds the managers' response was to develop class society, economic inequality and supporting ideologies. 8 he also documents the emergence of the military at this point. from this perspective, it becomes clear that the 1960s racism and militarism were the contemporary enforcers of an unjust economic order and that poverty itself is the primal civil injustice because structuring society in this way prevents the people whose work directly creates the wealth from receiving an equitable share of the profits generated together. economic inequality then prevents them from participating fully in society's economic sphere. the latter became more significant as financial and economic structures increased in sophistication. when mlk observed that post-1965 racial segregation was enforced by posting the menu with prices outside the restaurant as poor blacks would not bother entering (king 1986c) , he was close to recognizing poverty as the original civil injustice. however, he only saw economic inequality as a way of legally maintaining racism and its segregation, not that racism existed to enforce the unjust socioeconomic order. his recognition that the vietnam war was fought to maintain the economic order and that it could be replicated in other foreign countries (king 1967a) brought him closer to recognizing harman's (2017) view of the origination of the triple evils. the distinction of economic exploitation as the originator of an oppressive class society is very important as it highlights the value of mlk's founding his political activism for big on a call for a revolution of values tied to the restructuring of american society with the beloved community/world house as the end point. closely aligned with this is his preference for a dynamic big tied to the median income level. firstly, mlk was identifying the cause of poverty and seeking to address this cause. secondly, ontologically, big is a community process 9 ; this reality is demonstrated by the fact that the institution that has come closest to enacting big is the family, which is an embodiment of "us." therefore, it is reasonable to expect big would not be sustainable in a society founded on division. thirdly, as a review of the legislative history of divisive issues, from abortion to welfare benefits or voting rights, substantiates, legislation alone does not work to effect lasting change. this is because, as covey (2004) rightly emphasizes, actions flow from one's worldview or perception of reality. thus, sustainable socioeconomic or political change is predicated on the prior inner transformation of a significant segment of society. so in calling for a revolution of values to restructure american society, mlk identified a means of attaining sustainable economic change. fourthly, the revolution of values goes beyond political or religious ideology, which can be hard to bridge, to a deeply personal area that informs an individual's daily life while facilitating a sense of belonging in local and national communities. these characteristics of values are the very things that make mlk's justifications of peace and justice, fulfillment of the nation's promise and humankind's self-actualization potentially desirable to a very large segment of the population and capable of facilitating transformation into the world house's ethic of "a worldwide fellowship that lifts neighborly concern beyond one's tribe, race, class, and nation" to "an all-embracing and unconditional love for all men" that ultimately "preserve[s] the best in our individual societies" (king 1964) . finally, the quantitative particulars of mlk's big would have effected socioeconomic restructuring by providing a secure middle-class income as society's lowest financial threshold via the dignified means of work or an unconditional regular payment. mlk's activism is rooted in his methodology for nonviolent social change. therefore, his political activism is analyzed within this framework. they are also examined in conjunction with the responses to the campaign identified in the previous section and with what actually happened. mlk's methodology for nonviolent social change has six steps: gather comprehensive information on the issue; educate others on your position (especially the one(s) you want to persuade); daily renew your commitment to the principles of nonviolent living; negotiate and dialogue with goodwill; employ direct action when negotiation is not possible; build friendship, reconciliation and consensus with the other party as the beloved community is the ultimate goal (king center, n.d.) . direct action, the fifth step of this methodology, was used successfully in obtaining the 1964 and 1965 legislative victories as well as the supreme court's desegregation of the alabama bus system. direct action is meant to introduce creative tension into the negotiations and move the other party toward the desired outcome (king center, n.d.) . the brutality, immorality and injustice of segregation were revealed to the rest of the usa by the activists' nonviolent responses to the segregationists' behaviors. however, the segregationists were not the ones who made the changes. thus, the decision makers were not the perpetuators and very likely already had values that objected to what they witnessed. however, the ppc was highlighting a different situation. the ppc was challenging the values the decision makers lived. 10 it was challenging the country's economic and political foundations. add to this the idea of black dominance the term black power awoke in many nonblacks (king 1986c) , the threat of violence that was stoked by the fbi (jackson 2007 ) and the macro-system reality of the working and middle classes being economically comfortable during this period (janssen 2015) . the combination of these factors possibly explains the response from the press, the government, the fbi, the sharp difference in racerelated support for the campaign documented in the june 1968 survey and the small turn out for solidarity day: limited identification and possibly race-based fear. further, in setting the ppc, the task of actualizing america's promise, mlk was in the realm of fostering a new national identity and social compact. he was attempting a transition from the existing social conflict theory arrangement with its inequity and class conflicts to a humanistic model with an emphasis on the value of the individual and his/her capacity for freely chosen actualization and value-based living (hutchison 2015) . all of these new conditions particular to the second phase of the mcrm required adjustments to mlk's methodology. an alternate approach that puts modified versions of king's second and sixth steps of nonviolent social change (steps of education and formation of the beloved community) on par with the fifth step as initiators of creative tension could have been more successful. this would have included lots of aspirational and values-based reinforcement (as documented in his "world house" reflections [king 1964 [king , 1986c and as done successfully with his "i have a dream" speech [sinek 2009 ] 11 ) along with the demands of the economic and social bill of rights and exposure to the reality of poverty via the direct action of the ppc. a key aspect of this modified approach would have been his insights into how the triple evils employment of a "i-it" manner of relating rather than "i-thou" was damaging to both members of the interaction (king 1964 (king , 1986c . examples of the desired values at work could have included the wealthiest americans voluntarily paying taxes above ninety percent in the 1950s to help pay off budget deficits (freelander and taibbi 2012) . as noted previously, the sclc was founded to lead the civil rights movement. leadership is an essential aspect of political activism for it undertakes the function of deciding how to deploy resources to achieve the desired result. the specific tasks are considering vision, mission, values along with interior and exterior capacities, forces and developments to chart the optimal course (covey 2004 ). mlk's last book is a testament to his striving to do this. however, he was focused primarily on the current and future work to be done by the mcrm. analysis that includes the sclc and its history recognizes that the fight against racism, segregation, brutality and voter suppression was a vibrant, wide-spread, decades-long grassroots movement that "spontaneously" became multi-state and birthed the sclc. however, with his identification that the second stage of the work needed to attend to the triple evils, mlk was on the cutting edge of civil rights activism. thus, there was a need to build consensus and to deeply educate within the sclc 12 so the previous clarity of purpose and high level of investment born of experience and many years of struggle could be developed around this second phase. further, given mlk's recognition that the limited concrete changes resulting from the legislative victories were straining hope and splintering the dedication to nonviolence, systemic work to facilitate a recommitment to the principles of nonviolence would have been timely. both choices are also in keeping with covey's (2004) recognition that private achievements are the foundation of public ones. if these priorities had been attended to, it is very likely that dr. abernathy would have carried out the three-phased campaign and the sclc leaders would have stayed at resurrection city instead of at hotels as jackson (2007) documents. if the approach of taking time to deeply cultivate sclc's support for the second phase had been employed, a concurrent or subsequent phase would have been for the sclc to foster the previous level of commitment, action and creativity within the local organizations based on a thorough understanding of how the triple evils uniquely affected each organization as this new phase needed the fuel of persistent direct actions that local organizations provide. adaptability and adeptness at identifying and embracing opportunities are necessary aspects of successful leadership because the operating environment is fluid (covey 2004 ). the ppc is a testimony of mlk doing this. he recognized the need to create a coalition of the poor rather than just the mobilization of poor black americans. he learned from the afdc 13 mothers (jackson 2007) . he understood the value of pausing work for the national campaign to support the memphis sanitation workers, even after there was violence at their demonstration (king 1998) . however, even though he repeatedly referenced john kenneth galbraith's work when speaking about big, mlk did not extend the ppc's alliances to include the economist. it is possible that mlk overlooked this opportunity to simultaneously advance big and the beloved community/world house as in his methodology for nonviolent social change the beloved community/world house was the long-term outcome, not an immediate priority. also, his methodology is focused on bringing supporters into his movement, not forming coalitions with those who employed other strategies. long-term influences of dr. martin luther king jr.'s political activism on behalf of big this section is a brief review of significant big and/or economic justice political activism connected to mlk that occurred post-ppc. in may 1968, john kenneth galbraith, james tobin and other economists initiated a statement that was signed by over one thousand economists (bien, n.d.a). the ppc was the very first supporter of big identified in the second paragraph; the first paragraph urged congress to adopt a big that year (galbraith 1968 ). the economists' justification was that "[t]he country will not have met its responsibility until everyone in the nation is assured an income no less than the official recognized definition of poverty" (galbraith 1968 ). the petition resulted in a bill for the family assistance program, which was a form of negative income tax scheme; it was adopted by the house of representatives with a majority in august 1969, but rejected by the us senate in 1972, even after multiple amendments were adopted to diminish opposition (bien, n.d.a). the rev. dr. liz theoharis of union theological seminary's kairos center for religions, rights, and social justice and the rev. dr. william j. barber ii, president and sr. lecturer of repairers of the breach, are the founding co-chairs of the poor people's campaign: a national call for moral revival (ppc:ancmr) (breach, n.d.; kairos center, n.d.b) . dr. theoharis is also the director and a founding member of the kairos center's poverty initiative; over many years, she used this initiative to lay the foundation for the ppc:ancmr, which was announced on december 4, 2017, the fiftieth anniversary of mlk's announcement of the ppc, and is positioned as a continuation of mlk's work (barber and theoharis 2018a; kairos center, n.d.a). revs. dr. theoharis and dr. barber's justification for the ppc:ancmr is a refinement of mlk's as they articulate deepest religious and constitutional values through the lens of morality. however, they also invoke jesus, "a brown skinned palestinian jew," as unifier of the rejected and judger of nations based on their treatment of the poor and the marginalized, even as they beckon to those who do not follow a faith tradition but believe in love and justice and/or in morality as an inherent aspect of the universe (barber and theoharis 2018b). they insert the movement into the national and the biblical traditions of moral dissent and action for the oppressed (barber and theoharis 2018b). christian nationalism and ecological devastation are added to the intertwined evils endangering the soul and heart of america's democracy and limiting the country's ability to fully be (barber and theoharis 2018b). the movement is conceived as a fusion coalition that unites people across all the lines traditionally used to divide, that can sustain a multiyear campaign and that prioritizes giving power to the poor in the work of changing the national narrative and policy focus. moral analysis, moral articulation and moral action are the identified methodologies for simultaneous local and national activism. moral action includes moral discernment, moral dissent and moral disruption of the forces of injustice (barber and theoharis 2018a, b) . though the moral agenda that documents demands based on the campaign's the souls of poor folk audit's 14 findings (both documents were released at the campaign's april 2018 launch) includes a guaranteed annual income (barber and theoharis 2018a; ppc:ancmr 2018) , the campaign has chosen a guaranteed job at a living wage over big in its poor people's moral budget: everybody has the right to live on the grounds that a basic income is not large enough to meet a person's need (ppc:ancmr 2019). the movement also supports the right of workers to unionize and "fully-funded welfare programs that provide cash and inkind assistance directly to the poor" (ppc:ancmr 2019, 32) for those who cannot work. these three items are among those addressed under the section of the budget entitled "investment in domestic tranquility." the section of the budget focused on "investments in an equitable economy" seeks to hold corporations and the wealthy accountable by demanding they be charged increased taxes to help pay for social programs. it is noteworthy that their june 2019 forum attended by 2020 democratic party presidential candidates, part of a three-day poor people's moral action congress in washington dc, provided the opportunity for two candidates who have associated themselves with mlk (andrew yang and senator bernie sanders) to speak on their plans for poverty (segers 2019 ). the forum was attended by the then four leading 2020 democratic party presidential candidates (vice president joseph bidden, senator elizabeth warren, senator kamala harris and senator bernie sanders); president donald j. trump was invited to participate (kaplan 2019) . a big of $1000 monthly for everyone eighteen years and older was one of andrew yang's three main platform items; yang called it a freedom dividend (yang, n.d.a) . though he listed mlk as a supporter of big on his campaign website, yang's justification for big was that due to new technologies replacing human workers, there will not be enough jobs in the near future (yang, n.d.b) . senator sanders' 2016 presidential campaign was founded on economic justice. his 2020 platform was presented as a movement for "economic, racial, social and environmental justice for all" and he spoke of an economic bill of rights (sanders, n.d.a, n.d.c) ; thus, his language and issues resonated with mlk's during preparations for the ppc (king 1968; o'brien 2017) . senator sanders' plan to include poor people in the banking system (sanders, n.d.b ) took mlk's vision of economic justice further. senator sander's economic policy position included safeguarding union rights to rebuild the middle class and guaranteed jobs for all (sanders, n.d.c, n.d.e) , but not big. also, his personal biographical data on the 2020 campaign website did not include his participation in the mcrm as a young man (sanders, n.d.d) , information that was part of his 2016 presidential campaign. the black lives matter global network was founded in the usa during the second decade of the twenty-first century in response to police brutality toward black men. it is a member-led, chapter-based organization (black lives matter, n.d.a). it describes itself as "a collective of liberators who believe in an inclusive and spacious movement" (black lives matter, n.d.b). its mission is to create a world where "every black person has the social, economic, and political power to thrive." they also use the language of "beloved community" and commit to peace, justice and liberation in their intracommunity relations (black lives matter, n.d.b the analysis of the ppc revealed that mlk's justifications for big and his support of a dynamic big tied to the median income level are important developments in the history of big as they hold the potential for sustainable change, wide appeal and a restructuring of the injustice socioeconomic order that sustains poverty. however, his political activism did not directly move big closer to reality. this was due to limitations inherent to his methodological framework and the way it was implemented. therefore, it would be beneficial for mlk's thought and methodology to be developed further. this could include more scholarships on the political, social and economic policies/structures of the beloved community/world house and mlk's methodology for nonviolent social change. the analysis of the ppc's long-term influence indicated the campaign was not a failure. it was cited in john kenneth galbraith and colleagues' influential big petition. further, mlk's work is inspiring a new generation of big activists, even if, like andrew yang, some have different justifications. it is also very encouraging that hawk newsome is supporting big in his official capacity as a young mcrm leader, especially as big is not in alignment with his organization's priorities. this is a welcome development for big activists, given the ppc:ancmr's choice to favor a right to work over big. this choice brings the mcrm into a debate that has been active since the 1980s (harvey 2004 ) and can be considered a fracturing of the mcrm on the level of stokely carmichael's 15 choosing black power over the commitment to nonviolence and eventual reconciliation with white americans. this is such a splintering of the movement because by choosing a guaranteed job and fully funded welfare programs, they are abandoning mlk's mission to restructure the system that causes beggars. for fully funded welfare programs, even if achieved through the poor having a voice in the policy formulation and political processes, result in a mere rearrangement of the current system. they are also walking away from the potential for sustainable socioeconomic change particular to mlk's justifications for big and the quantitative specifics of the big he supported. however, this is not surprising as mlk's support of big is linked to his nonviolent philosophy and the end goal of the beloved community/world house. while the ppc:ancmr utilizes mlk's language and ideas, it has not included the beloved community/world house as the ultimate goal. also, while mlk developed nonviolence as a way of life that cultivates peace regardless of the personal cost, nonviolence is listed as the last of the ppc:ancmr's twelve fundamental principles (king 1964; ppc:ancmr, n.d.) . and the principle of nonviolence is presented in a manner tht could be interpreted primarily as a rejection of violent behavior. this occurrence in the modern civil's rights movement's approach to economic justice makes development of mlk's work even more important. the intensification of the triple evils is another reason for further advancement of mlk's thought, particularly those associated with big and economic injustice. putnam (2013a, b) identifies the three big trends 15 stokely carmichael was the president of the student nonviolent coordinating committee. the organization was cofounded with the sclc. however, it was renamed student national coordination committee after it separated itself from the nonviolent methodology in favor of black power. stokely carmichael was the first within the mcrm to publicly use the phrase "black power". in american society from the 1980s to the present as severe income inequality, social class segregation and a loss of the sense of community that translate to less opportunity for poor children. for putnam, it is a deviation from the core of the american dream/promise that each young person would have an equal start and subsequent success would be based on the individual's efforts. putnam (2016) is equally concerned that the increased segregation and inequality will adversely impact the country's economy and social character since american society is designed to function with a high level of social capital/trust. the trends are not just in the usa. freelander and taibbi (2012) recognize the same movement toward economic inequality across western societies. and in his 2015 encyclical laudato si': on care for our common home, pope francis (2015) identifies society's many ills, global and local, as stemming from the globalization of the dichotomizing, profit-prioritizing "technocratic paradigm" that fails to even acknowledge the inherent value and form of the other. thus, there is continued need for a revolution of values that would restructure society nationally and internationally. if the new way chosen is that of the beloved community/world house, big is an integral part of it. the inverse is equally true: as already discussed, big cannot be sustainably achieved without including political activism founded on dr. king's entire philosophy. the 2020 covid-19 pandemic that laid bear humanity's indisputable interdependence highlights these reciprocal truth. therefore, the pandemic has the potential to be a catalyst for action towards mlk's expanded dream. america, america, what's going on?: a moral critique creating a moral movement for our times a call for moral basic income earth network (bien). n.d.a basic income earth network (bien). n.d.b speaker's profile: hawk newsome black lives matter. n.d.a black lives matter. n.d.b black lives matter greater new york. n.d.a breach repairers (breach). n.d the story of how michael king jr. became martin luther king jr class resurrection: the poor people's campaign of 1968 and resurrection city american civil rights movement the 7 habits of highly effective people lincoln. leadership in war new negro congress of racial equality great migration reconstruction and the new south, 1865-1900 laudato si': on care for our common home. encyclical letter. rome: the vatican plutocracy rising economists' statement on guaranteed annual income a people's history of the world the right to work and basic income guarantees: competing or complementary goals?" accessed dimensions of human behavior. person and environment california: sage from civil rights to human rights: martin luther king jr. and the struggle for economic justice the reluctant welfare state the reverend dr. liz theoharis 2020 democrats address poverty and systemic racism at presidential forum major king events chronology 1929-1968 stride to freedom: the montgomery story nobel lecture beyond vietnam address delivered at the eleventh annual sclc convention martin luther king jr.'s call for a poor people's campaign i have dream (1963) letter from a birmingham jail (1963) where do we go from here: chaos or community? the autobiography of martin luther king jr martin luther king jr history of naacp naacp history: medgar evers mission and history martin luther king and the economic and social bill of rights regional council of negro leadership a new and unsettling force; reigniting rev. dr. martin luther king's poor people's campaign poor people's moral budget fundamental principles robert putnam-the american dream in crisis robert putnam-the opportunity gap explained on our civic life in decline bernie on the issues fair banking for all jobs and an economy for all meet bernie the workplace democracy plan candidates to face questions from low-income americans at forum. accessed how great leaders inspire action the king philosophy policy what is ubi? key: cord-258570-3n7jp0l0 authors: baatiema, leonard; sumah, anthony mwinkaara; tang, prosper naazumah; ganle, john kuumuori title: community health workers in ghana: the need for greater policy attention date: 2016-12-02 journal: bmj glob health doi: 10.1136/bmjgh-2016-000141 sha: doc_id: 258570 cord_uid: 3n7jp0l0 from the 1970s to the 1990s, the who, united nations and other agencies mooted the idea of formally training and recognising community health workers (chws) to complement efforts to improve primary healthcare delivery in low and middle income countries. recently, chws have been recognised as important players in the achievement of the health-related millennium development goals (mdgs). despite this recognition, little understanding exists in ghana about the activities of chws: who they are; how they are recruited; what they do; level of health policy support; contribution to healthcare delivery and the challenges they face. based on a rapid scoping review of the existing literature, and our experience working in ghana, this paper reflects on the role of chws in healthcare delivery in ghana. we argue that chws have played critical roles in improving health service delivery and outcomes, including guinea worm eradication, expanded immunisation coverage, maternal and child health, and hiv/aids treatment and management. however, these achievements notwithstanding, chws face challenges which prevent them from being optimally productive, including capacity problems, neglect by the healthcare system, high attrition rates and inadequate supervision. policymakers in ghana therefore need to give increased attention to chws, provide remuneration for their activities, create career opportunities and other means of motivations to boost their productivity and sustain gains associated with their activities. the concept and role of community health workers (chws) have enjoyed renewed interest in global health since the alma-ata declaration in 1978. [1] [2] [3] [4] [5] [6] chws have evolved over the past decades with its antecedence in the 'feldshers' in 17th-century russia, 7 the barefoot doctors programme in china during the early 1920s, 8 and the who seminal work 'health by the people' in 1975. 9 recent recognition that chws are important players in global efforts to achieve the health-related millennium development goals (mdgs) highlights this attention. 10 in 2013, the one million chws campaign project worth us$2.5 billion was announced to boost the capacity of chws to deliver healthcare in sub-saharan africa. 11 this current drive to recruit more chws is a recognition of their role in sustaining the mdg gains, as well as in ultimately achieving the more recent sustainable development goals (sdgs). a surge in the evidence of their contribution has recently been acknowledged in a cochrane review on maternal and child health. 12 evidence in several low and middle income countries (lmics) suggests that marked reductions in child and maternal mortality through health promotion interventions, immunisation campaigns and other community driven initiatives could be attributed in part to the role played by chws. [11] [12] [13] [14] [15] key questions what is already known about this topic? ▸ the contributions of community health workers (chws) to healthcare delivery have been recognised globally. ▸ there is a lack of global consensus on chws' scope of practice. ▸ there is inadequate health policy support for chws in low and middle income countries. what are the new findings? ▸ this analysis presents systematic and comprehensive evidence of chws' contributions and health policy gaps in ghana. ▸ it has contributed in clarifying the various classification of chws and their scope of practice. ▸ it has also highlighted evidence of inadequate health policy support for chws. ▸ the formulation of a national policy on chws. ▸ the establishment of a professional and regulatory body to regulate the standards and practice of chws. ▸ the development of a long-term strategy that will see the gradual replacement or absorption of chws into the formal health service in ghana. with the current ageing population and wave of epidemiological transition globally (the impact of which is projected to be felt more by populations in lmics), studies suggest that chws are rising to the task of ensuring that the impact is less felt by communities and health systems. [16] [17] [18] the potential contributions of chws to tackling the current global health security threat posed by the zika virus, yellow fever, middle east respiratory syndrome (mers) and influenza, especially in the area of surveillance, cannot be overemphasised. despite the general consensus about the importance of chws among the global health community, health policy interventions to recognise and support optimal delivery of healthcare by chws are lacking, especially in lmics. in ghana, although a number of studies and reports have highlighted chws' activities, 16 19 20 there is inadequate health policy support for them. to the best of our knowledge, no studies currently exist in ghana to have systematically profiled chws and their contribution to healthcare delivery. there is yet no consensus or comprehensive assessment of their roles, scope of activities and constraining factors to their productivity in ghana. this analysis paper therefore addresses this knowledge and policy gap. to analyse the activities of chws and the extent of health policy support in ghana, we conducted a literature review of published and unpublished works, including reports on the activities of chws in ghana (see box 1 for search strategy deployed to search and retrieve relevant literature for this study). this paper also incorporates insights from our experiences of working in ghana as community health services researchers, affiliates of the ghana health service and development workers who have contributed to the design and implementation of numerous community-driven health interventions in collaboration with chws. despite an international consensus about the importance of chws to healthcare delivery, a universal definition of chws remains evasive. ambiguity further abounds in the mainstream literature on the characterisation of chws. 21 however, during the recent united states agency for international development (usaid) chw evidence summit, there was some consensus that a chw is "a health worker who receives standardized training outside the formal nursing or medical curricula to deliver a range of basic health, promotional, educational, and mobilization services and has a defined role within the community system and larger health system". 22 we find this definition to be insightful and thus will significantly support our analysis of chws in this paper. in ghana, two complementary types of chws are notable. the first category are an informal, poorly trained health service-supporting chws. in this category, chws are informally a part of the health system, and the health authorities or collaborating development partner (non-governmental organisation, ngo) takes responsibility for their recruitment, training, incentives and/or remuneration. the second strand of chws exists where chws are representatives of the community and act in the interest of the community. chws under this category have no or limited affiliation with the formal healthcare system, and mainly spearhead community-driven preventive health activities. despite this distinction, we admit that many chws might be combining both roles in practice. from our experiences and in our view, a 'hybrid' form of chws (a mix of the two categories) can be found in ghana. similar to the international trend, chws are diversely named in ghana, including but not limited to names such as community health volunteers (chvs), traditional birth attendants (tbas), village health volunteers, community health champions, peer health educators, community child growth promoters, community nurses, community health committee members, community-based surveillance volunteers (cbsvs), community-based agents and lay health workers. 16 19 20 23-26 these different characterisations generally reflect the diverse and ambiguous identities of chws in the international health literature and in health policy programmatic interventions. 10 21 27-29 for the purpose of clarity, we refer to chws in this paper as any of the above category of health workforce who, though not formal employees of the health system in ghana, are either a health service-supporting chw or community representatives, who have been identified, a rapid literature review of both published and unpublished works was conducted in academic science complete, cinahl, embase, global health medline, google scholar, isi web of knowledge, popline pubmed, psycinfo and web of science. no year limit was included in the search. we also undertook a review of reports on the activities of community health workers (chws) in ghana. the search sought to retrieve relevant documents ( programmatic and scholarly reports) on the activities of chws, especially in ghana, using key words such as community health workers, chw, village health worker, community health volunteer, lay health worker, traditional birth attendants, tbas, health promoters, ghana, remuneration, financing, health policy, impact, activities, training, practice and training. relevant papers and information were retrieved and reference lists screened for more relevant studies. studies which discussed the activities of chws with particular reference to ghana were critically assessed for relevant information. in order to establish the activities of chws in the context of the globe, works related to chws in general were included based on relevance to the study aim. in addition, the scope of the literature included in this paper was confined to works which reported, described, analysed and synthesised the activities of chw in the context of ghana. importantly, the paper incorporates insights on the activities of chws through anecdotes, authors' personal experiences and field reports. trained or untrained, and assigned roles in the community for which they receive no or some form of formal remuneration. historically, chws such as tbas have operated in most ghanaian communities. 30 however, attempts to formally organise and recognise them came after the alma-ata declaration on primary health care (phc). village health workers (vhws) provided the first semblance of chws in ghana. these were local community representatives whose actions and activities were mostly based on altruism. although their roles such as community mobilisation, health awareness creation and immunisation campaigns were critical to the modest gains ghana achieved from implementing the phc strategy, their activities were short-lived such that by the 1980s, vhws were no longer used. lack of coordination and inadequate supervision of their activities were among the reasons why the vhws programme was discontinued. as a result, community health nurses (chns) were introduced to deliver healthcare in mostly deprived parts of ghana. 24 unlike the vhws, chns were recruited, provided professional training in nursing training colleges, deployed into mostly rural parts of ghana and formally remunerated to provide healthcare. however, the relatively long period needed to train them and funding challenges limited adequate training and deployment of chns. consequently, the activities of vhws were reinvigorated in the early 1990s. central to their re-emergence was the navrongo experiment, a pilot project which culminated in the current community-based health planning and services (chps) concept. 24 26 since then, chws have continued to evolve both in name and role. currently, cbsvs form the majority of chws in ghana. however, there is still lack of clarity on their contribution, recruitment, scope of practice and remuneration. chws: contributions to healthcare in ghana evidence of the success of a plethora of community health interventions supported and delivered by chws exists in the international health policy and systems research literature. 12 13 27 31 although chws are involved in many domains of healthcare delivery in ghana, our review identified four important areas where chws' contributions have been immense. these four areas are examined in this paper. the navrongo experiment is one of the areas where chws' contributions to healthcare delivery have been acknowledged globally. the navrongo community health and family planning project, popularly referred to as the navrongo experiment, which culminated in the birth of the current chps programme in ghana, sought to improve access to healthcare in deprived communities using mostly community-driven resources and structures. the intervention was conceptualised under the assumption that by recruiting, training and deploying community health officers to rural communities, inequities in access to healthcare services between urban and rural settings could be bridged. under the navrongo experiment, chws played several critical roles, including outreach services, community mobilisation for health educational talks and referral to health facilities. 32 33 the navrongo experiment resulted in increased access to healthcare services, immunisation coverage, reduced child and maternal mortality while improving the rural population's overall health. for example, within a period of 3 years of its implementation, the results pointed to a 50% reduction in childhood mortality rate and 15% reduction in fertility rate. 24 given this landmark success, results from this experimental intervention led to the conceptualisation and implementation of the chps programme as the country's main policy enactment aimed at improving access to health services in rural ghana. owing to its overall success, ghana's chps programme has been acclaimed as among the most successful community-based health programmes globally. [32] [33] [34] [35] guinea worm eradication without the diverse contributions of cbsvs, ghana's current success in eradicating the guinea worm (dracunculiasis) would have been unlikely. ghana was ranked second globally in 2006 among the guinea worm endemic countries. 36 37 currently, however, ghana is guinea worm free. studies and reports from the ghana health service and non-state actors (ngos) have underscored the critical roles played by chws in eradicating the guinea worm in ghana. [38] [39] [40] [41] their roles included community mobilisation for awareness raising campaigns on the spread of the guinea worm, administration of palliative care, door-to-door distribution of drugs, referral to health centres for treatment, and distribution of water filters in communities. 38 39 42 43 indeed, their role was so critical that both the national guinea worm eradication programme and some development partners (eg, carter center) have acknowledged it as being the most important factor in ghana's guinea worm eradication campaign. 44 promotion of maternal and child health globally, chws have been acclaimed as having played a tremendous role in decreasing childhood illnesses and mortalities. 13 45 46 notably, case management of childhood illness is one area where their contribution has been highly commended by the who and unicef. 47 a study in ghana reported that chws were instrumental in establishing community health post, making home visits to provide healthcare services such as administration of antibiotics, oral rehydration solution and zinc to treat childhood illnesses such as pneumonia, diarrhoea and malaria. 48 similar results have been reported by other studies globally. 20 23 24 49 50 again in ghana, the role of tbas has been reported to double the number of women referred to clinics and hospitals for potentially life-saving care and support. 51 indeed, in several communities in bolgatanga, kassena nankana and bawku west districts of ghana, oxfam has trained and evaluated the work of some 150 tbas. 30 51 the evidence from oxfam's work has shown positive results. in each of the communities where oxfam trained and worked with tbas, the number of women being referred by tbas to clinics and hospitals for potentially life-saving care doubled. 51 maternal mortality has similarly reduced by 7%. 51 further, between 2005 and 2007, one of the authors ( jkg) was involved in a community-based pilot health project in 30 communities in nadowli district, upper west region, ghana. 30 this project was implemented by world vision ghana in partnership with ghana health services. the project trained cbsvs and tbas to perform a number of tasks, including recording births and deaths, and reporting disease outbreaks. 30 several tbas also got trained to detect danger signs during pregnancy and labour and to make quick referral of pregnant women to health facilities to receive skilled care. 30 the tbas were all provided basic consumables such as hand gloves, hand sanitisers, new packs of cutting blades and kerosene lanterns (to be used in the night when there is no electricity). the main aim of the project was to improve tbas' skills and resource them adequately to conduct normal deliveries, particularly in hard-to-reach rural communities. in mid-2007, an initial evaluation was done. the evaluation results showed that antenatal care attendance in some communities had increased twofold (ie, 41% in 2005 to 85% in 2007). 30 qualitative interviews with women and tbas suggested that many tbas who received the training and essential consumables actively encouraged and referred pregnant women to healthcare facilities. 30 also, among women who delivered at home with tbas, infections resulting from the use of bare hands and other unhygienic practices by tbas (such as the same blade being used to sever the umbilical cords of two babies) during labour were reported to have reduced. the women and tbas who participated in the interviews largely attributed the increase in the number of referrals to health facilities for skilled delivery and a reduction in infections during labour to the training tbas received and the supply of hand gloves, hand sanitisers and new blades. 30 in fact, these positive results from ghana are supported by evidence from other low income contexts. [52] [53] [54] [55] [56] notwithstanding these evidences, tbas' activities in maternal healthcare until now are still surrounded with controversies because the who official position only permits tbas to make referrals and not conduct home deliveries. 30 51 however, based on this evidence from the upper east region and the fact that in ghana only 55% of births are attended to by a skilled attendant (defined here as a doctor, nurse or midwife), and 30% by tbas, 30 we consider the who position on tbas as untenable in lmics such as ghana where the capacity to provide skilled and supervised delivery is limited. in other parts of the world especially in sub-saharan africa, the role of chws has been important in the fight against the spread of hiv/aids. 5 57-60 in ghana, the literature suggests that chws were recognised as a conduit to providing voluntary counselling and testing services. a cross-sectional survey conducted in northern ghana reported an overwhelming acceptance (98.7%) of the use of lay health counsellors to provide community-based voluntary counselling and testing services. 19 we noted, however, that only a few studies have covered the activities of chws in hiv/aids prevention and treatment in communities. our experience in working at the community level in ghana shows that chws are a key cadre of health staff working closely with chos and ngos in raising hiv/aids awareness, mobilising communities against stigma and discrimination and providing a culturally acceptable or a community-competent context for people living with hiv/aids. despite this, the district health information management system (dhims), a comprehensive database which reports on all aspects of services delivered by the ghana health service, does not report on chws' contribution to hiv/aids prevention and management. this suggests that even in contexts where their contribution is not in doubt, the healthcare system has not adequately documented or recognised their role. prior to the inception of the one million chw campaign (to which we return later), there was no national framework to guide the recruitment of chws in ghana. as a result, their recruitment was dependent on the community, the health programme, and the donor agency or development partner (ngo) involved. from the international literature 48 50 and our experiences in ghana as well, chws are generally recruited from their own communities based on their level of acceptability in their respective communities, previous involvement in community-driven initiatives, high sense of dedication to duty and literacy (education) level. although these considerations are important, they are no doubt subjective and may affect the objective assessment and recruitment of chws. our experience in some communities shows that the lack of clearly defined recruitment criteria and strategy has often generated tensions among community members. indeed, some earlier studies have indicated how recruiting chws from local communities often served to generate tension and/or perpetuate gender inequalities. 61 an important dimension regarding the recruitment of chws in ghana is the active role of ngos and other non-state actors. many ngos and other non-state actors who operate and/or implement parallel or vertical healthcare programmes in ghana often recruit parallel chws. in most cases, this parallel recruitment is often without regard for existing structures. from our experience, the ngos' style of engagement with chws can be problematic because recruiting chws without recourse to already existing structures can breed conflicts, duplication of efforts, lack of community participation and ownership of a particular health intervention and redundancies following the completion of the programmes of such organisations. comparable to the global situation, the scope of practice for chws lacks clarity and remains undefined in ghana. there has been a long-standing debate as to what exactly their roles should be and to what extent they are supposed to act in providing healthcare. 21 62 according to a report by unicef, in south asia, one chw can provide healthcare services to about 10 to 1000 households. 63 generally, chws tend to provide more preventive and promotive healthcare, rather than curative. 11 27 in other settings, the roles of chws have been observed to vary from community mobilisation for immunisation campaigns, health talks, first aid, creating awareness on disease control and health promotion to activities such as registration of births and deaths. 12 21 27 64 in ghana, owing to the acute shortage of health personnel, chws' scope of practice has broadened beyond prevention and health promotional activities to encompass some curative care such as treatment for malaria and diarrhoea. generally, the scope of practice of chws in ghana varies widely, including serving as aids to community health officers, home visits, disease surveillance, maintaining environmental sanitation, nutrition education, home management of minor ailments like uncomplicated malaria, social mobilisation, and providing a limited range of reproductive and child health services. 38 65 while this varied and flexible scope of practice may be a unique strength, it is therefore to be inferred that the lack of clarity on the operational mandates of chws in ghana has often undermined the effectiveness and efficiency of their roles in healthcare delivery at the community level. as observed by some researchers, a reasonable involvement of chws in limited activities has the tendency to enhance outcomes in community-based health interventions compared with an unlimited scope of practice. 31 remuneration of chws is a controversial subject that has eluded consensus among stakeholders. 38 66 internationally, the discourse is suggestive of the need to compensate their services in the form of a fee or in kind by the beneficiary communities. some other nonmonetary incentives such as providing bicycles, certificates or free healthcare to chws are also common. 31 67 68 as a result, the who has underscored the need to pay chws reasonable wages in order to enhance their productivity, sustain community-driven interventions and reduce their attrition rates. [69] [70] [71] the available literature has copiously cited the positive correlation between incentivising chws and lower rates of attrition. 13 21 57 72 in ghana, chws are not remunerated by governments, 48 and a spirit of volunteerism and altruism is rather emphasised. chws are required to draw satisfaction from community recognition, ability to gain skills and experience and the opportunity it presents to them to build social capital and access other job opportunities. this contradicts the who position and existing literature, which recommend the remuneration of chws. 73 74 for instance, in the work of lehmann and sanders, 21 the non-payment of chws under the premise that they were volunteers and offered services based on altruistic motives failed to motivate the chws to support the sustainability of community-based health interventions. our experience suggests that contrary to the government's view that chws activities should be inspired by altruism, chws usually have high expectations of rewards in the form of regular wages, stipends and some form of career opportunities to eventuate them into the health system. while chws are gaining increasing attention as important players in healthcare delivery in ghana and elsewhere, they are beset with multiple challenges. chws face capacity problems as they receive little or no formal training. one author noted this as a fundamental concern among chws as most of the experience they require for their job are gathered on the job. 4 quite notably, the ghana health service recently attempted to address this challenge by developing training guides for some categories of chws. 65 however, from our experience, there has been limited uptake of these training guides. we have also observed the inadequate supply of basic equipment such as wellington booths, bicycles, hand gloves and the first aid kit that some chws use to facilitate their work. neglect or inadequate recognition of chws is another fundamental challenge. as noted earlier, the absence of a policy directive on chws lends credence to our position. the current policy position of the government, which does not remunerate chws for contributing to deliver community health service, only exacerbates the dwindling enthusiasm of chws and the time they commit to their duties. this, to a large extent, affects negatively their productivity and retention. further, this has the potential to increase their attrition rates as has been reported in other settings to vary between 3.2% and 77%. 13 50 75 also, the attendant long-run effect of this situation is the high costs involved in selecting and training new chws as replacements. the inadequate recognition of chws has further led to the lack of a framework to regulate their practices as evidenced in the varying roles chws assume as espoused in earlier sections of this paper. the situation creates an inherent ambiguity and varying expectations of their roles which affects the optimum engagement of chws. in ghana, there are neither mechanisms nor a framework to regulate their practice or certify chws as having the requisite competencies to practice as in the case of other health professionals such as medical doctors, nurses or chns. to be able to attain standardisation and integration of the services of chws into the health system, a form of oversight is required. this may take the form of a regulatory or professional body which will provide some form of certification or licensing to duly recognise their competencies and standardise their practices. lack of effective supervision of chws is one of the notable problems chws face in ghana. our experiences in northern ghana suggest that laxity in the supervision of chws is mainly due to the already overstretched nature of the health system, which is attributable in part to the human resources for health crises. given that chws are now taking up more curative care activities in addition to the preventive-based care interventions, their activities should be supervised and coordinated closely to potentially optimise their productivity and improve health outcomes as evident in studies from other settings. 64 76 77 also, a further step by the ministry of health (moh) to scale up the number of frontline staff to provide healthcare to the rural communities is the current partnership with the one million chw campaign project to introduce a new cadre of chws in ghana. this represents an important health policy direction in improving access and health outcomes of the rural populace in ghana. the one million chw campaign proposed to introduce a world-class cadre of chws to extend essential health services to household levels functioning as an integral component of the community health system. 78 conceptually and based on the literature on chws, this category of chws will be an informal extension of the formal healthcare system with explicitly defined roles, training and remuneration to augment the delivery of healthcare. notably, this new cadre of chws differs substantially from the chws who are the subject of this paper except in their duties. while the policy issues of existing chws still remain to be addressed, the new programme only proposes to recognise the existing chws provided they will be useful in providing voluntary assistance to the formally remunerated new cadre of chws, and their continuous existence will be dependent on the particular health district. a justifiable policy question may therefore be why introduce a new cadre of chws to take up duties which were essentially carried out by a particular workforce but whose contribution has hitherto not been recognised and whose integration into the new programme has not been explicitly addressed. if such concerns are not addressed, there will most likely be challenges such as conflicting roles, tension between chws of the one million chw campaign and existing chws, lack of community participation and a threat to the sustainability of community-based health interventions. the preceding analysis points to a general policy deficit regarding chws in ghana, given the lack of a national framework to guide activities of chws such as recruitment, credentialling, scope of practice, remuneration, career development, performance management, supervisory mechanisms, integration into the formal health system, capacity development and logistical requirement and deployment. despite the active involvement of chws in the health system, they are invisible nationally and subnationally in terms of policies, strategies and budgeting. 78 we therefore recommend the following immediate and long-term measures to forestall anticipated and existing challenges faced by chws: 1. the establishment or enactment of a national policy on chws which should define and outline the relevant aspects of their recruitment, credentialling, scope of practice, remuneration, career development, performance management, supervisory mechanisms, integration into the formal health system, capacity development and logistical requirement and deployment. 2. the establishment of a professional and/or regulatory body that will exercise oversight over chws by defining, monitoring or enforcing the standards and practice of chws in ghana including licensing or a form of certification. 3. the development of a long-term strategy that will see the gradual replacement or absorption of chws into the mainstream or formal health service in ghana. 4. that the proposed one million chw campaign project should incorporate an integration plan aimed at enlisting existing deserving chws who have a wealth of experience and skill to their credit and to further develop the capacities of those with inadequate skills to enable them to enlist and participate in the programme. 5. finally, policy steps should be taken to critically review the who position on tbas' roles in promoting maternal health. given the shortage of skilled birth attendants (sbas) in ghana and across sub-saharan africa as indicated by the latest who report on the 'state of the world's midwifery', 79 it is clear that the ideal of ensuring skilled attendance at all births is not feasible or achievable in the short term. therefore, reasonably acceptable equity and efficiency arguments can be made for the building of working partnerships with and incorporation of tbas into the maternal healthcare system in contexts such as ghana where skilled maternal healthcare provision is acutely limited. 30 indeed, widespread collaboration through policy support for the healthcare system to identify, train and enhance the skill sets of tbas is recommended. partnerships between tbas and sbas would also be critical for helping healthcare workers to learn from tbas how best to address the cultural needs and concerns of childbearing women. 30 thus, even if the ghanaian health system were to train and deploy sufficient numbers of sbas to all parts of the country in the future, tbas could still play important roles in helping healthcare workers to provide culturally competent care. 30 conclusion this relatively modest contribution by chws to healthcare delivery in ghana suggests the need for state and non-state actors alike to build better working partnerships with chws, provide financial remuneration, create career opportunities and other means of motivations to boost their productivity and sustain gains associated with their activities. in addition, there is the need for policy definition to harmonise the issues relating to chws in general. this is because chws play an indispensable role in delivering health to their communities and assume and actively play the role of health activists and advocates. the reported challenges faced by chws can be addressed through appropriate national policy articulation, and therefore development partners should work in partnership with the government of ghana to put in place these policies. handling editor douglas noble. contributors lb and ams conceived the study. lb, ams, pnt and jkg searched the literature. lb drafted the manuscript. all authors contributed substantially to the review of the manuscript for critical and intellectual content. all authors have read and approved the final version of the manuscript for publication. competing interests none declared. provenance and peer review not commissioned; externally peer reviewed. data sharing statement no additional data are available. open access this is an open access article distributed in accordance with the creative commons attribution non commercial (cc by-nc 4.0) license, which permits others to distribute, remix, adapt, build upon this work noncommercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. see: http:// creativecommons.org/licenses/by-nc/4.0/ producing effective knowledge agents in a pluralistic environment: what future for community health workers? thirty years after 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practices and incomes of health workers: evidence from an evaluation of a delivery fee exemption scheme in ghana are large-scale volunteer community health worker programmes feasible? the case of sri lanka a community health worker intervention to address the social determinants of health through policy change community health workers "101" for primary care providers and other stakeholders in health care systems frontline health workers coalition. a commitment to community health workers: improving data for decision making the state of the world's midwifery 2011: delivering health, saving lives key: cord-271693-7tg21up3 authors: zheng, fan; zhang, she; churas, christopher; pratt, dexter; bahar, ivet; ideker, trey title: identifying persistent structures in multiscale ‘omics data date: 2020-10-03 journal: biorxiv doi: 10.1101/2020.06.16.151555 sha: doc_id: 271693 cord_uid: 7tg21up3 in any ‘omics study, the scale of analysis can dramatically affect the outcome. for instance, when clustering single-cell transcriptomes, is the analysis tuned to discover broad or specific cell types? likewise, protein communities revealed from protein networks can vary widely in sizes depending on the method. here we use the concept of “persistent homology”, drawn from mathematical topology, to identify robust structures in data at all scales simultaneously. application to mouse single-cell transcriptomes significantly expands the catalog of identified cell types, while analysis of sars-cov-2 protein interactions suggests hijacking of wnt. the method, hidef, is available via python and cytoscape. significant patterns in data often become apparent only when looking at the right scale. for example, single-cell rna sequencing data can be clustered coarsely to identify broad categories of cells (e.g. mesoderm, ectoderm), or analyzed more sharply to delineate highly specific subtypes (e.g. pancreas islet β-cells, thymus epithelium) [1] [2] [3] . likewise, protein-protein interaction networks can inform groups of proteins spanning a wide range of spatial dimensions, from protein dimers (e.g. leucine zippers) to larger complexes of dozens or hundreds of subunits (e.g. proteasome, nuclear pore) to entire organelles (e.g. centriole, mitochondria) [4] . many different approaches have been devised or applied to detect structures in biological data, including standard clustering, network community detection, and low-dimensional data projection [5] [6] [7] , some of which can be tuned for sensitivity to objects of a certain size or scale (so-called 'resolution parameters') [8, 9] . even tunable algorithms, however, face the dilemma that the particular scale(s) at which the significant biological structures arise are usually unknown in advance. guidelines for detecting robust patterns across scales come from the field of topological data analysis, which studies the geometric "shape" of data using tools from algebraic topology and pure mathematics [10] . a fundamental concept in this field is "persistent homology" [11] , the idea that the core structures intrinsic to a dataset are those that persist across different scales. recently, this concept has begun to be applied to analysis of 'omics data and particularly biological networks [12, 13] . here, we sought to integrate concepts from persistent homology with existing algorithms for network community detection, resulting in a fast and practical multiscale approach we call the hierarchical community decoding framework (hidef). hidef works in the three phases to analyze the structure of a biological dataset (methods). to begin, the dataset is formulated as a similarity network, depicting a set of biological entities (e.g. genes, proteins, cells, patients, or species) and pairwise connections among these entities (representing similarities in their data profiles). the goal of the first phase is to detect network communities, i.e. groups of densely connected biological entities. communities are identified continually as the spatial resolution is scanned, producing a comprehensive pool of candidates across all scales of analysis (fig. 1a) . in the second phase, candidate communities arising at different resolutions are pairwise aligned to identify those that have been redundantly identified and are thus persistent (fig. 1b) . in the third phase, persistent communities are analyzed to identify cases where a community is fully or partially contained within another (typically larger) community, resulting in a hierarchical assembly of nested and overlapping biological structures ( fig. 1c,d) . hidef is implemented as a python package and can be accessed interactively in the cytoscape network analysis and visualization environment [14] (availability of data and materials). we first explored the idea of measuring community persistence via analysis of synthetic datasets [15] in which communities were simulated and embedded in the similarity network at two different scales (supplementary fig. 1a; methods) . notably, the communities determined to be most persistent by hidef were found to accurately recapitulate the simulated communities at the two scales (supplementary fig. 1b-g) . in contrast, applying community detection algorithms at a fixed resolution had limited capability to capture both scales of simulated structures simultaneously (supplementary fig. 2; methods) . we next evaluated whether persistent community detection improves the characterization of cell types. we applied hidef to detect robust nested communities within cell-cell similarity networks based on the mrna expression profiles of 100,605 single cells gathered across the organs and tissues of mice (obtained from two datasets in the tabula muris project [16] ; methods). these cells had been annotated with a controlled vocabulary of cell types from the cell ontology (co) [17] , via analyses of cell-type-specific expression markers [16] . we used groups of cells sharing the same annotations to define a panel of 136 reference cell types and measured the degree to which each reference cell type could be recapitulated by a hidef community of cells (methods). we compared these results to toomanycells [18] and conos [19] , two recently developed methods that generate nested communities of single cells in divisive and agglomerative manners, respectively (methods). reference cell types tended to better match communities generated by hidef than those of other approaches, with 65% (89/136) having a highly overlapping community (jaccard index > 0.5) in the hidef hierarchy ( fig. 2a,b, supplementary fig. 3a,b) . this favorable performance was observed consistently when adjusting hidef parameters to formulate a simple hierarchy, containing only the strongest structures, or a more complex hierarchy including additional communities that are less persistent but still significant (fig. 2c, supplementary fig. 3c) . the top-level communities in the hidef hierarchy corresponded to broad cell lineages such as "t cell", "b cell", and "epidermal cell". finer-grained communities mapped to more specific known subtypes (fig. 2d) or, more frequently, putative new subtypes within a lineage. for example, "epidermal cell" was split into two distinct epidermal tissue locations, skin and tongue; further splits suggested the presence of still more specific uncharacterized cell types (fig. 2e) . hidef communities also captured known cell types that were not apparent from 2d visual embeddings (supplementary fig. 4a,b) , and also suggested new cell-type combinations. for example, astrocytes were joined with two communities of neuronal cells to create a distinct cell type not observed in the hierarchies of toomanycells [18] , conos [19] , or a two-dimensional data projection with umap [20] (fig. 2f, supplementary fig. 4c ). this community may correspond to the grouping of a presynaptic neuron, postsynaptic neuron, and a surrounding astrocyte within a so-called "tripartite synapse" [21] . next, we applied hidef to analyze protein-protein interaction networks, with the goal of characterizing protein complexes and higher-order protein assemblies spanning spatial scales. we benchmarked this task by the agreement between hidef communities and the gene ontology (go) [22] , a database that manually assigns proteins to cellular components, processes, or functions based on curation of literature (methods). application to protein-protein interaction networks from budding yeast and human found that hidef captured knowledge in go more significantly than previous pipelines proposed for this task, including the nexo approach to hierarchical community detection [23] and standard hierarchical clustering of pairwise protein distances calculated by three recent network embedding approaches [24] [25] [26] (fig. 3a, fig. 7) . we also applied hidef to analyze a collection of 27 human protein interaction networks [27, 28] . we found significant differences in the distributions of community sizes across these networks, loosely correlating with the different measurement approaches used to generate each network. for example, bioplex 2.0, a network characterizing biophysical protein-protein interactions by affinity-purification mass-spectrometry (ap-ms) [29] , was dominated by small communities of 10-50 proteins, whereas a network based on mrna coexpression [30] tended towards larger-scale communities of >50 proteins. in the middle of this spectrum, the string network, which integrated biophysical protein interactions and gene co-expression with a variety of other features [31] , contained both small and large communities (fig. 3c) . in agreement with the observation above, the hierarchy of bioplex had a relatively shallow shape in comparison to that of string (and other integrated networks including giant and pcnet [27, 32] ), in which communities across many scales formed a deep hierarchy (fig. 3d ,e; availability of data and materials). in contrast to clustering frameworks, hidef recognizes when a community is contained by multiple parent communities, which in the context of protein-protein networks suggests that the community participates in diverse pleiotropic biological functions. for example, a community corresponding to the mapk (erk) pathway participated in multiple larger communities, including ras and rsk pathways, sodium channels, and actin capping, consistent with the central roles of mapk signaling in these distinct biological processes [33] (supplementary fig. 8) . the hierarchies of protein communities identified from each of these networks have been made available as a resource in the ndex database [34] (availability of data and materials). to explore multiscale data analysis in the context of an urgent public health issue, we considered a recent application of ap-ms that characterized interactions between the 27 sars-cov-2 viral subunits and 332 human host proteins [35] . we used network propagation to select a subnetwork of the bioplex 3.0 human protein interactome [36] proximal to these 332 proteins (1948 proteins and 22,835 interactions) and applied hidef to identify its community structure (methods). among the 251 persistent communities identified (fig. 3f) , we noted one consisting of human transducin-like enhancer (tle) family proteins, tle1, tle3, and tle5, which interacted with sars-cov2 nsp13, a highly conserved rna synthesis protein in corona and other nidoviruses (fig. 3g) [37] . tle proteins are well-known inhibitors of the wnt signaling pathway [38] . inhibition of wnt, in turn, has been shown to reduce coronavirus replication [39] and recently proposed as a covid-19 treatment [40] . if interactions between nsp13 and tle proteins can be shown to facilitate activation of wnt, tles may be of potential interest as drug targets. community persistence provides a basic metric for distilling biological structure from data, which can be tuned to select only the strongest structures or to include weaker patterns that are less persistent but still significant. this concept applies to diverse biological subfields, as demonstrated here for single cell transcriptomics and protein interaction mapping. while these subfields currently employ very different analysis tools which largely evolve separately, it is perhaps high time to seek out core concepts and broader fundamentals around which to unify some of the ongoing development efforts. to that effect, the methods explored here have wide applicability to analyze the multiscale organization of many other biological systems, including those related to chromosome organization, the microbiome and the brain. consider an undirected network graph , representing a set of biological objects (vertices) and a set of similarity relations between these objects (edges). examples of interest include networks of cells, where edges represent pairwise cell-cell similarity in transcriptional profiles characterized by single-cell rna-seq, or networks of proteins, where edges represent pairwise protein-protein biophysical interactions. we seek to group these objects into communities (subsets of objects) that appear at different scales and identify approximate containment relationships among these communities, so as to obtain a hierarchical representation of the network structure. the workflow is implemented in three phases. phase i identifies communities in at each of a series of spatial resolutions . phase ii identifies which of these communities are persistent by way of a panresolution community graph ! , in which vertices represent communities, including those identified at each resolution, and each edge links pairs of similar communities arising at different resolutions. persistent communities correspond to large components in ! . phase iii constructs a final hierarchical structure that represents containment and partial containment relationships (directed edges) among the persistent communities (vertices). community detection methods generally seek to maximize a quantity known as the network modularity, as a function of community assignment of all objects [41] . a resolution parameter integrated into the modularity function can be used to tune the scale of the communities identified [9, 42, 43] , with larger/smaller scale communities having more/fewer vertices on average (fig. 1a) . of the several types of resolution parameter that have been proposed, we adopted that of the reichardt-bornholdt configuration model [42] , which defines the generalized modularity as: where ⃗ defines a mapping from objects in to community labels; " is the degree of vertex ; is the total number of edges in ; is the resolution parameter; ( , ) indicates that vertices and are assigned to the same community by ⃗ ; and is the adjacency matrix of . to determine two values satisfying the above formula are defined as -proximal. the sampling step, which was practically set to 0.1 to sufficiently capture the interesting structures in the data; it is conceptually similar to the nyquist sampling frequency in signal processing [44] . we used $"% = 0.001, which we found always resulted in the theoretical minimum number of communities, equal to the number of connected components in . we used $&' = 20 for single-cell data ( fig. 2 to identify persistent communities, we define the pairwise similarity between any two communities and as the jaccard similarity of their sets of objects, ( ) and ( ): we initialize a hierarchical structure represented by , a directed acyclic graph (dag) in which each vertex represents a persistent community. a root vertex is added to represent the community of all objects. the containment relationship between two vertices, and , is quantified by the containment index (ci): which measures the fraction of objects in shared with . an edge is added from to in if ( , ) is larger than a threshold ( is -contained by ). since ( , ) < for all , (a property established by the procedure for connecting similar communities in phase ii), setting ≥ 2 /(1 + ) guarantees to be acyclic. in practice we used a relaxed threshold = , which we found generally maintains the acyclic property but includes additional containment relations. in the (in our experience rare) event that cycles are generated in , i.e. ( , ) ≥ and ( , ) ≥ , we add a new community to , the union of and , and remove and from . finally, redundant relations are removed by obtaining a transitive reduction [45] of , which represents the hierarchy returned by hidef describing the organization of communities. the biological objects assigned to each community are expanded to include all objects assigned to its descendants. throughout this study, we used the parameters = 0.75, = 5, = 75. note that since is a threshold of minimum persistence, the results under a larger value of ′ can be produced by simply removing communities with persistence lower than ′ (figs. 2c, 3afig. 9 ). different combinations of parameters and typically do not significantly change the performance of hidef in the benchmark tests on protein-protein interaction networks (supplementary fig. 6 ), except that certain parameters (e.g. = 0.9) are less robust to network perturbation (i.e. randomly deleting edges from networks). we found that combining hidef with node embedding resolved this issue and further improved the performance and robustness (supplementary fig. 7 ; see sections below). simulated network data were generated using the lancichinetti-fortunato-radicchi (lfr) method [15] (supplementary figs. 1,2) . we used an available implementation (lfr benchmark graphs package 5 at http://www.santofortunato.net/resources) to generate benchmark networks with two levels of embedded communities, a coarse-grained (macro) level and a fine-grained (micro) level. within each level, a vertex was exclusively assigned to one community. two parameters, c and f, were used to define the fractions of edges violating the simulated community structures at the two levels. all other edges were restricted to occur between vertices assigned to the same community (supplementary fig. 1a) . we fixed other parameters of the lfr method to values explored by previous studies [9] . some community detection algorithms include iterations of local optimization and vertex aggregation, a process that, like hidef, also defines a hierarchy of communities, albeit as a tree rather than a dag. we demonstrated that without scanning multiple resolutions, this process alone was insufficient to detect the simulated communities at all scales (supplementary fig. 2) . we used louvain and infomap [46, 47] , which have stable implementations and have shown strong performance in previous community detection studies [48] . for louvain, we optimized the and other parameters to default. in general, these settings generated trees with two levels of communities. note that infomap sometimes determined that the input network was nonhierarchical, in which cases the coarse-and fine-grained communities were identical by definition. mouse single-cell rna-seq data ( fig. 2; supplementary fig. 3 identical analyses were applied to the facs and the droplet datasets respectively, yielding a hierarchy of 273 and 279 communities respectively (fig. 2d) . scanpy 1.4.5 [49] was used to create tsne or umap embeddings and associated two-dimensional visualizations [20] as baselines for comparison (fig. 2e,f; supplementary fig. 3a,b) . through previous analysis of the single-cell rna data, all cells in these datasets had been annotated with matching cell-type classes in the cell ontology (co) [17] . before comparing these annotations with the communities detected by hidef, we expanded the set of annotations of each cell according to the co structure, to ensure the set also included all of the ancestor cell types of the type that was annotated. for example, co has the relationship "[keratinocyte] (is_a) [epidermal_cell]", and thus all cells annotated as "keratinocyte" are also annotated as "epidermal cell". the co was obtained from http://www.obofoundry.org/ontology/cl.html and processed by the data driven ontology toolkit (ddot) [50] retaining "is_a" relationships only. we compared hidef to toomanycells [18] and conos [19] as baseline methods. the former is a divisive method which iteratively applies bipartite spectral clustering to the cell population until the modularity of the partition is below a threshold; the latter uses the walktrap algorithm to agglomeratively construct the cell-type hierarchy [51] . we chose to compare with these methods because their ability to identify multiscale communities was either the main advertised feature or had been shown to be a major strength. toomanycells (version 0.2.2.0) was run with the parameter "min-modularity" set to 0.025 as recommended in the original paper [18] , with other settings set to default. this process generated dendrograms (binary trees) with 463 communities. the walktrap algorithm was run from the conos package (version 1.2.1) with the parameter "step" set to 20 as recommended in the original paper [19] , yielding a dendogram. the greedymodularitycut method in the conos package was used to select n fusions in the original dendrogram, resulting in a reduced dendrogram with 2n+1 communities (including n internal and n+1 leaf nodes). here we used n = 125, generating a hierarchy with 251 communities (fig. 2c) . the communities in each hierarchy were ranked to analyze the relationships between celltype recovery and model complexity (fig. 2c, supplementary fig. 3c) . hidef communities were ranked by their persistence; conos and toomanycells communities were ranked according to the modularity scores those methods associate with each branch-point in their dendrograms. conos/walktrap uses a score based on the gain of modularity in merging two communities, whereas toomanycells uses the modularity of each binary partition. we obtained a total of 27 human protein interaction networks gathered previously by survey studies [27, 28] , along with one integrated network from budding yeast (s. cerevisiae) that had been used in a previous community detection pipeline, nexo [23] . this collection contained two versions of the string interaction database, with the second removing edges from text mining (labeled string-t versus string, respectively; fig. 3 ). benchmark experiments for the recovery of the gene ontology (go) were performed with string and the yeast network ( fig. 3a,b, supplementary fig. 4) . the reference go for yeast proteins was obtained from http://nexo.ucsd.edu/. a reference go for human proteins was downloaded from http://geneontology.org/ via an api provided by the ddot package [50] . hidef was directly applied to all of the above benchmark networks. the nexo communities were obtained from http://nexo.ucsd.edu/, with a robustness score assigned to each community. to benchmark communities created by hierarchical clustering, we first calculated three versions of pairwise protein distances (hc.1-3; fig. 3a,b; supplementary fig. 4) using mashup, dsd and deepnf [24] [25] [26] . mashup was used to embed each protein as a vector, with 500 and 800 dimensions for yeast and human, as recommended in the original paper. a pairwise distance was computed for each pair of proteins as the cosine distance between the two vectors. similarly, deepnf was used to embed each protein into a 500-dimensional vector by default. dsd generates pairwise distances by default. given these pairwise distances, upgma clustering was applied to generate binary hierarchical trees. following the procedure given in the nexo and mashup papers [23, 24] communities with <4 proteins were discarded. since all methods had slight differences in the resulting number of communities, communities from each method were sorted in decreasing order of score, enabling comparison of results across the same numbers of top-ranked communities. hidef communities were ranked by persistence. nexo communities were ranked by the robustness value assigned to each community in the original paper [23] . to rank each community c of hierarchical clustering (branch in the dendrogram), a one-way mann-whitney u-test was used to test for significant differences between two sets of protein pairwise distances: (set 1) all pairs consisting of a protein in c and a protein in the sibling community of c; (set 2) all pairs consisting of a protein in each of the two children communities of c. the communities were sorted by the one-sided p-value of significance that distances in set 1 are greater than those in set 2. we adopted a metric average f1-score [52] to evaluate the overall performance of multiscale structure identification, focusing on the recovery of reference communities. given a set of reference communities * and a set of computationally detected communities ⃗ , the score was defined as: where ( ) is the best match of " in ⃗ , defined as follows: and 1( " , 1 sss⃗ ) is the harmonic mean of precision( " , 1 sss⃗ ) and recall( " , 1 sss⃗ ). the calculations were conducted by the xmeasures package (https://github.com/exascaleinfolab/xmeasures) [53] . hidef was directly applied to the original networks in in most of our analyses of protein-protein interaction networks, and compared with the results of hierarchical clustering following the network embedding techniques [24, 26] . we sought to explore if we can combine the strength of network embedding and hidef to further improve the performance and robustness to parameter choices (supplementary fig. 7) . we borrowed the idea of shared-nearest neighbor (snn) graph that we had been using in the analyses of single-cell data. we made a customized script to use the 500-dimensional node embeddings of the string network as the input of the seurat findneighbors function [3] . the parameters of this function remained as the default. the output snn graph has 1.65 ´ 10 6 edges, which is on the same magnitude as the original network (2.23 ´ 10 6 edges). we then applied hidef to this snn graph with different combinations of parameters ( supplementary fig. 7) . 332 human proteins identified to interact with sars-cov-2 viral protein subunits were obtained from a recent study [35] . this list was expanded to include additional human proteins connected to two or more of the 332 virus-interacting human proteins in the new bioplex 3.0 network [36] . these operations resulted in a network of 1948 proteins and 22,835 interactions. hidef was applied to this network with the same parameter settings as for other protein-protein interaction networks (see previous methods sections), and enrichment analysis was performed via g:profiler [54] (fig. 3f,g) . not applicable. not applicable. these models include the hierarchy of murine cell types (fig. 2) , the hierarchies of yeast and human protein communities identified through protein network analysis, and the hierarchy of human protein complexes targeted by sars-cov2 (fig. 3) . t.i. is cofounder of data4cure, is on the scientific advisory board, and has an equity interest. t.i. . a yeast network [23] and the human string network [31] were used as the inputs of a and b, respectively. hc.1-3 represent upgma hierarchical clustering of pairwise distances generated by mashup, dsd, and deepnf [24] [25] [26] , respectively. c, distributions of community sizes (x-axis, number of proteins) for three human protein networks: bioplex 2.0 [29] , coexpr-geo [30] , and string [31] . supplementary figure 1 . exploring simulated networks. a, the lfr generative model [15] was used to simulate networks with 1000 vertices and average degree 10 (methods). the simulation included two layers of communities, "coarse" (10-20 communities, 50-100 vertices per community) and "fine" (25companion plots to panels (b-d). points represent identified communities, delineated by size (y axis) and persistence (x axis). blue/gray point colors indicate a match/non-match to a true community in the simulated network (jaccard similarity > 0.75). note that when noise is low (e), the highest persistence communities correctly recover simulated communities with near-perfect accuracy, e.g. for persistence threshold >20. hidef is compared with the louvain and infomap algorithms [46, 47] , with louvain and infomap fixed at their default single resolutions (methods). the three plots (a-c) compare the performance of the three algorithms in recovering simulated communities at different settings of the coarse/fine mixing parameters (see supplementary fig. 1 clustering following any of three protein pairwise distance functions (mashup, dsd, and deepnf) [24] [25] [26] . using the performance analysis depicted in fig. 3b , the area under curve (auc) was computed for different sets of hidef parameters (p, ). this auc was compared to that of the best baseline tool, hc.3 (i.e. hierarchical clustering of pairwise distances generated by deepnf [26] ) to generate an equal number of communities (methods). note the ratio hidef auc / hc.3 auc is usually higher than 1, indicating the favorable performance of hidef except for very high values of the t parameter. as per fig. 3b , the analysis was undertaken using the string network and the go cellular component branch. b, similar analysis with subsampling of network edges (in which a random 10% of network edges are removed prior to community detection at each resolution). higher persistence (y axis) than a given threshold (x axis). e-f, scatterplots of community size (y axis) versus persistence (x axis). the left column characterizes the single-cell transcriptomics data (fig. 2, supplementary fig. 3) . the right column (panel b, d, f) characterizes the yeast and human protein-protein interaction datasets ( fig. 3a-b) . the human cell atlas data-driven phenotypic dissection of aml reveals progenitor-like cells that correlate with prognosis integrating single-cell 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of a directed graph fast unfolding of communities in large networks maps of random walks on complex networks reveal community structure scanpy: large-scale single-cell gene expression data analysis ddot: a swiss army knife for investigating data-driven biological ontologies computing communities in large networks using random walks overlapping community detection at scale: a nonnegative matrix factorization approach accuracy evaluation of overlapping and multiresolution clustering algorithms on large datasets profiler: a web server for functional enrichment analysis and conversions of gene lists (2019 update) the reactome pathway knowledgebase we are grateful for the helpful discussions with drs. jianzhu ma, karen mei, and daniel carlin. reactome [55] . key: cord-027765-jxxcvbna authors: jones, daniel j title: the potential impacts of pandemic policing on police legitimacy: planning past the covid-19 crisis date: 2020-06-05 journal: nan doi: 10.1093/police/paaa026 sha: doc_id: 27765 cord_uid: jxxcvbna one of the biggest challenges facing modern policing in recent years has been the lack of police legitimacy. the tipping point of this phenomenon is often attributed to the rodney king incident in los angeles in 1991, where los angeles police department (lapd) officers were videoed assaulting a lone black male. they were arrested and charged but eventually all were acquitted, thereby etching deep distrust between communities and police. now the rodney king example is an extreme and criminal act by police but it was the beginning of communities and media focusing on what the police were doing and how they were doing it. this lack of legitimacy coupled with what is referred to as the militarization of policing have lasting consequences and impacts on police–community relations and how interactions between police and community shape society today. in the wake of pandemic policing due to covid-19, there are tales of two eventualities for police legitimacy that will be explored in this article: (1) the police response to the pandemic results in further militarization and draws deeper divides between police and communities or (2) the police response is compassionate and build on procedurally just operations resulting in the rebuilding of police legitimacy post-pandemic. the covid-19 pandemic has put the world into a situation of uncertainty. many organizations are treading on unknown territory and have no blueprint for how to manage the crisis and its consequences. police are having to respond to and assist in a public health crisis enforcing new laws and bylaws that are regularly changing as governments take information from epidemiologists and virologists on how to manage this global pandemic. as the government relies on the justice system to ensure community safety and to protect the community not only from common threats to public or individual safety such as domestic violence, gangs, guns, or drugs but also from covid-19, they afford them with additional powers. how the police carry out those powers and policies during the pandemic becomes of utmost importance as these drastic measures can impact police legitimacy. whether or not the police can successfully respond to this crisis does not only depend on lawmakers university of huddersfield united kingdom and edmonton police service edmonton canada. email: dan.jones@edmontonpolice.ca. this article discusses the potential impacts that pandemic policing could have on police legitimacy. policing, volume 0, number 0, pp. 1-8 doi:10.1093/police/paaa026 v c the author(s) 2020. published by oxford university press. all rights reserved. for permissions please e-mail: journals.permissions@oup.com or the government but also on public trust and confidence, and the public is seeing the police as a legitimate power holder. research consistently shows that whether the public trusts the police and views it as legitimate has important consequences of whether or not people obey the law (bottoms and tankebe, 2012; mazerolle et al., 2013; terrill et al., 2016) . consequently, in these very uncertain times, the police must understand their impacts, the construct of police legitimacy, the tenets of procedural justice, and put a substantial amount of effort into avoiding to create an us versus them mentality amid this pandemic (reicher and stott, 2020) . the concept of police legitimacy implies that the police are seen as a legitimate power holder who uphold the law and operate in the community in a procedurally just way, giving a voice to the people they serve (bottoms and tankebe, 2012; mazerolle et al., 2013; tankebe et al., 2016) . research has shown if the police are perceived as a legitimate power holder, community members are more likely to comply and cooperate with police and less likely to re-offend (paternoster et al., 1997; sunshine and tyler, 2003; bottoms and tankebe, 2012, mazerolle et al., 2013) . there is also greater satisfaction with the police, less resistance to police, and less support for vigilante violence (paternoster et al., 1997; sunshine and tyler, 2003) . conversely, the opposite is true when police are not seen as legitimate. community members are less likely to comply and cooperate, show more resistance (bolger and walters, 2019) , and also more often feel that when they report to the police nothing will be accomplished (brunson and wade, 2019; crehan and goodman-delahunty, 2019) in addition to the perception that nothing would be done, communities in which police lack legitimacy tend to have overwhelming fears of abuse by the police. the police now more than ever need to ensure that their actions are procedurally just and work to build legitimacy with the entire population that they serve. in this, the police must acknowledge that the 'community' is made up of several communities that are not homogenous and may require nuanced policing (rinehart kochel, 2011; bottoms and tankebe, 2012) . the concepts of procedural justice and police legitimacy are not new and agencies across the world have worked towards implementing procedurally just practices in order to enhance police legitimacy (picket et al., 2018; antrobus et al., 2019) . however even with the adoption of procedurally just policing, police legitimacy, or the lack of police legitimacy is a challenge for police agencies (smith, 2017; cheng, 2020; deuchar et al., 2020) . in research with incarcerated populations 'distrust in police' was found to be one of the main reasons that these individuals never reported their victimizations, even prior to their entry into the criminal justice system (jones et al., 2019; d. j. jones, unpublished data) . as police agencies pivot due to the need to provide safety to the public with new legislation and enhanced police power, it is crucial the police continue down the path of procedural justice to enhance police legitimacy and public confidence (picket et al., 2018; antrobus et al., 2019) . when one analyses policing deployments in conventional times, the police are disproportionately deployed to marginalized communities where they interact with the public in some form on a more regular basis than they do in nonmarginalized areas. unfortunately, research has shown that police are often seen as unjust in their procedures or lack compassion in their interactions, thus resulting in a state of reduced legitimacy (rinehart kochel, 2011; jones and mcguire, 1999; unpublished paper) . the over-policing of marginalized neighbourhoods and communities is particularly worrisome during the pandemic, when the police have to enforce new public health laws and ensure public safety while depending on the public's willingness to comply with social distancing or lockdowns in a way that they never had to before. at the same time, police are tasked more than ever to prevent civil unrest. communities that already have strained relationships with the police might have a harder time complying with the new rules and regulations. as police legitimacy is often lower in disadvantaged communities (kane, 2005; gau and brunson, 2010; mazerolle and wickes, 2015) , there is the potential that the population does not see the laws as necessary. as such, it becomes even more important for the police to be (and be perceived as) legitimate and procedurally just to gain compliance from community members (murphy et al., 2009) . how police respond in this current crisis will have long-lasting impacts on legitimacy and police-community relationships far beyond the reach of the pandemic. in this article, we will discuss two likely eventualities for how police may respond to this pandemic, how this will affect police legitimacy, and then conclude with where this may take modern policing in the post-pandemic era. there are, and always will be multiple different potential outcomes at the end of any disaster or war. however, historically people have often responded to these disastrous events by coming together and building community (reicher and stott, 2020) . this is true for society in general; however, for policing, the long-term consequences of the pandemic can go in different directions. while there are various scenarios, we argue that there are two very distinct possibilities for police legitimacy past the pandemic threat of covid-19: (1) the police response to the pandemic results in further militarization and draws deeper divides between police and communities or (2) the police response is compassionate and operates procedurally just resulting in the rebuilding of police legitimacy post-pandemic. the first potential option is that the already over-militarized modern police agencies currently requiring reform (balko, 2013) become ever-more militarized moving farther away from the community and being less approachable and accountable to the public. the concept of militarization of police is not about the equipment that the police have, it is about how the police interact with the public with a 'warrior' mindset negating community relationships (balko, 2013; goldsworthy, 2018) . an additional concern is that police perceptions of using procedural justice diminish with negative demeanour of the citizens in which they interact (nix et al., 2017) , responding to crowds that are protesting public health ordinates could then result in potentially violent conflict. the consequence of this would likely see police operating in a manner that society would not perceive as procedurally just, thereby further widening the gap between police and the community. over the past several years, policing has worked towards better serving the communities in which they police (lum et al., 2016) . the effectiveness of police reform is unclear (bell, 2016) ; however, if the pandemic response by police is militarized and lacks procedural justice, it risks any progress that has been done in recent years when police underwent reform and improved police-community relationships (lum et al., 2016; tyler, 2019) . unfortunately, just a few weeks into the pandemic, there are already some early signs that the relationship between police and the community is changing for the negative. it must be said that police agencies across the world are not homogeneous, and the police in the uk, europe, australia, canada, and the usa have worked to embrace police reform through procedural justice (president's task force on 21st century policing, 2015; hough et al., 2017) . unfortunately, negative media has an impact on police legitimacy and the community as a whole does not differentiate one police agency from another (li et al., 2016; intravia et al., 2018) . an example of negative media during pandemic policing is reports coming from south africa state that just days into their 21-day lockdown as a result of covid-19, police are abusing their powers in multiple ways while enforcing their newly enhanced powers enacted from their disaster management act: assaultive behaviour by police and the death of three people at the hands of law enforcement officers (faull, 2020) . ironically, the same number of people had been reported to have died as a result of the virus at that time (faull, 2020) . the experience in south africa may be an extreme example. however, it exemplifies some of the potential societal consequences of the covid-19 pandemic: anger and civil unrest as well as violent and deadly interactions with the police. governments across the globe are declaring states of emergencies in response to the pandemic, enacting new laws, and enhancing the powers of law enforcement organizations. these legislative practices are being afforded with the intention that the exponential growth of coronavirus is halted or at least slowed down (greenstone and nigam, 2020) . as new laws come into play, the police must understand that it is not just the legislation that creates consternation and fear; it is how the police enforce these laws. if the police enforce the laws in a manner that lacks procedural justice and is excessively militaristic lacking in community engagement, there is a risk of civil unrest (reicher and stott, 2020) . if the community questions the legitimacy of the new laws as well as the police themselves, compliance is unlikely to occur (murphy et al., 2009) . the concern of the potential for abuse of power and militarization of police has already been discussed in multiple international media reports (faull, 2020; leung, 2020) . when the police are required to enforce curfews, social distancing, and social isolation ordinates, and it is done militarily with no regard for the relations with the community, there might be significant ramifications. currently, the media are reporting numerous issues of police abuse of power worldwide. in acadia parish, la, the police sounded the same siren that was sounded in the purge films 1 to indicate that the curfew time had started and that all citizens should clear the streets. while the sounding of the siren alone is not an egregious issue, it is a decision by police that caused fear to members of the community (russian, 2020) . in india, officials sanitized storefronts with firehoses spraying bleaching agents, and police ordered they also spray on a crowd of people at a bus stop (leung, 2020). allegedly, a 13-year-old was shot and killed by police in kenya for breaking a coronavirus enacted curfew, while a police officer in the philippines forced two minors and three adults into a dog cage for 30 min and threatened to shoot them if they did not stay in the cage for a curfew breach (leung, 2020) . these examples of power abuse can have lasting implications for police-community relationships. past research has also shown that such adverse media reports can have lasting impacts on police legitimacy independent of where such incidents occur (graziano and gauthier, 2018; intravia et al., 2018) . considering these adverse reports and examples of power abuse, police agencies across the world are at risk of proving to society that they are using extreme measures to address the new laws that have been enacted by the government forgoing their relationships with community and confirming that the militarization of police is fully embedded in modern policing (balko, 2013; goldsworthy, 2018) . the second option is that the police embrace a guardian mindset during these unprecedented and uncertain times. the ideology of the guardian is to work with communities and embrace their role as one that is not only there to arrest and incarcerate but to engage community in non-enforcement conversations, and assist in solving problems in the community (lum et al., 2016; peyton et al., 2019) . this option would require police to follow, or continue to follow the tenets of procedural justice, even in the face of the novel coronavirus (covid-19) pandemic. police working together 1 the purge films were about a 12-h period of lawlessness that allowed all crimes ranging from theft to murder to be legal. with community members and community leaders in a partnership is a proven way to enhance informal social controls so that people obey the law (schuck, 2019) . one of the tenets of procedural justice implies fairness when dealing with individuals who are suspected of breaking the law. the main component of that is giving people a voice in their own justice experience by allowing the individual to tell their version of the events that brought them into contact with the justice system and listening to them without prejudice to their account. this becomes challenging during a pandemic; however, police need to understand the potential stress that the population is feeling as a result of the covid-19 crisis. disasters or mass traumas regardless of if they are natural (i.e. hurricanes, tsunamis, or earthquakes, etc.) or humaninitiated (terrorist attacks, mass shootings, etc.) result in spikes of post-traumatic stress responses, increased alcohol and drug use, and other mental health crisis (galea et al., 2020) . police can work with communities and community leaders to provide a venue to have these conversations using different technologies for virtual community conversations. police in this time of crisis, must increase communication with citizens through traditional media, social media, fliers, etc. as face to face meetings are restricted due to covid-19. ideally, this account should be used to make fair decisions. in the event, people are breaching orders to socially distance, or something as simple as going to the park when they have been shut down due to the pandemic, rather than significant fines police may want to have a warning and a conversation and explain why the public health orders are necessary. findings from the queensland community engagement trail in 2012 showed that when given an explanation as to why the police were taking action, increased cooperation, and police legitimacy (mazerolle et al., 2012) , this would intimate that police could use education rather than suppression to gain public support and adherence to public health ordinates. policing crowds or protests with procedural justice is a challenge (radburn et al., 2018) . in order to be effective in policing crowds, specifically as it pertains to protests relating to covid-19, police need an enhanced sense of togetherness with the community (radburn et al., 2018) . police communication needs to occur often and be clear, compassionate, and voluntary to help build legitimacy (chanin and courts, 2017) . it may also be prudent during the pandemic to have shared communication platforms between police, health authorities, community leaders, and political leaders so that in this time of crisis, expectations of the citizens are clear. another cornerstone of procedural justice is transparency which is built by having open communications (biggs, 2018; ramirez, 2018) . the police must be fully transparent about their actions with the public so that the public understands why and how the police are acting. procedural justice also implies impartiality on the part of law enforcement so that all communities feel that they are equal and that the police are equitable in the distribution of justice (mazerolle et al., 2013) . it is this last point, in particular, where the police risk failing during this pandemic. in the usa, particularly in the southern usa, people of colour and those who are impoverished are being the hardest hit from the pandemic (laughland, 2020) . marginalized populations are often disproportionately policed, and thereby over-represented in the justice system (rinehart kochel, 2011) while also now being impacted at higher rates by the pandemic. if police are not procedurally just in these uncertain and challenging times, particularly with marginalized populations, one could imagine long-term impacts on police legitimacy past the pandemic response. if the police respond with compassion and care when they are required to enforce public health laws due to the pandemic response of the respective nation, this could build police legitimacy in a time of crisis. if the police are to be seen as legitimate in these times, they must find opportunities for using education to explain the need to enforce laws that are put in place to reduce the spread of the coronavirus. communication with the community becomes of utmost importance as even if the laws themselves are not seen as legitimate if the police are communicating with the public through a lens of procedural justice, they have the ability to increase compliance (murphy et al., 2009) . transparency as to what the police are doing about the pandemic response and why they are doing it will help to build legitimacy with the public and the police (jackson, 2015) . finally, the police need to ensure that the dialogues with the community are re-evaluated by keeping open lines of communication with community members and leaders to determine if they continue to be satisfied with the police response to the pandemic, as this could build and foster police legitimacy. as bottoms and tankebe have laid out, continuous dialogue with the community is critical (bottoms and tankebe, 2013) . if this dialogue builds the legitimacy of the police, then we should see more compliance with the laws and less resistance to the police (sunshine and tyler, 2003; paternoster et al., 1997) . all of these benefits could greatly assist the police in their pandemic response. one way to work towards building legitimacy is via positive media news stories. we know media have an impact on police legitimacy (intravia et al., 2018) and broadcasting positive news stories regarding police interactions with the public and highlighting procedurally just actions in both conventional and social media can be quite effective in building and foster legitimacy. while positive media stories of police in the midst of this pandemic are hard to find, there is some hope. there are some tweets of support for frontline workers and frontline staff are being thanked in the mainstream media. in this author's police service, two members responded to a report of a sudden death during the pandemic. the death was of a southeast asian woman and was not suspicious in any way. with the pandemic, there was no opportunity for a funeral of any kind. the husband told the officers that he was unable to find white flowers so that he could at least honour his wife at home. the two members left the residence, found and purchased white flowers, and delivered them to the husband so that he was able to offer a proper goodbye to his loved one. there is no doubt that these types of events are happening in policing across the globe, but the stories that are in the media are the negative ones with negative and lasting impacts on police legitimacy. it is important for police to highlight the positive interactions with communities to provide balance in the media. this second option is by far the better one for policing during and beyond the pandemic. authoritarian militarized policing may seem like the quickest and most efficient response in these uncertain times; however, they may be the hardest to overcome in the long run. now, possibly more than ever, police leaders need to ensure that procedurally just practices are occurring between police and public. the responsibility of the police is to ensure the safety of the public with the assistance of the newly enhanced powers and legeslation. it becomes of significant importance for police leaders to articulate to their police officers that how they interact with the community in these uncertain times will either build or damage police legitimacy (tyler and jackson, 2014) . winston churchill once stated, 'never waste a good crisis.' this is an opportunity for the police to build on existing legitimacy and to rebuild lost legitimacy with the most marginalized communities. police leaders must communicate to their respective organizations the importance of procedural justice, and remind the membership how to achieve it by ensuring fairness, giving the people participation or a voice, demonstrating transparency, and being impartial (mazerolle et al., 2013) . this might also be an excellent opportunity for researchers to evaluate how police are building, fostering, or losing legitimacy along the way. importantly, both longitudinal quantitative surveys about police legitimacy as well as in-depth interviews (likely via zoom or skype) about community members' experiences with their interactions with police and how the police's actions during the pandemic are perceived would provide important insights into policing and police legitimacy during the pandemic and what implications it might have for post-pandemic times. procedural justice training for police recruits: results of a randomized controlled trial rise of the warrior cop: the militarization of america's police forces police reform and the dismantling of legal estrangement transparency portals and why they are needed in law enforcement organizations the relationship between police procedural justice, police legitimacy, and people's willingness to cooperate with law enforcement: a meta-analysis beyond procedural justice: a dialogic approach to legitimacy in criminal justice oh hell no, we don't talk to police" insights on the lack of cooperation in police investigations of urban gun violence examining the determinants of police department online transparency input without influence: the silence and scripts of police and community relations procedural justice and complaints about police cops in crisis?: ethnographic insights on a new era of politicization, activism, accountability, and change in transatlantic policing state abuses could match the threat of covid-19 itself the mental health consequences of covid-19 and physical distancing: the need for prevention and early intervention procedural justice and order maintenance policing: a study of inner-city young men's perceptions of police legitimacy' why australia should be wary of the rise of the warrior cop, with tools to match media consumption and perceptions of police legitimacy does social distancing matter policing, procedural justice and prevention investigating the effects of media consumption on attitudes toward police legitimacy respect and legitimacy-a two-way street: strengthening trust between police and the public in an era of increasing transparency voices of remanded women in western canada: a qualitative analysis compromised police legitimacy as a predictor of violent crime in structurally disadvantaged communities concerns raised about extreme measures, power abuse during virus lockdowns is bad stronger than good? the impact of police-citizen encounters on public satisfaction with police an evidence-assessment of the recommendations of the president's task force on 21st century policing: implementation and research priorities police legitimacy in community context procedural justice, routine encounters and citizen perceptions of police: main findings from the queensland community engagement trial (qcet) procedural justice and police legitimacy: a systematic review of the research evidence nurturing regulatory compliance: is procedural justice effective when people question the legitimacy of the law? demeanor, race, and police perceptions of procedural justice: evidence from two randomized experiments do fair procedures matter? the effect of procedural justice on spouse assault a field experiment on community policing and police legitimacy testing a social schematic model of police procedural justice final report of the president's task force on 21st century policing when is policing fair? groups, identity and judgements of the procedural justice of coercive crowd policing social media affordances in the context of police transparency: an analysis of the first public archive of police body camera videos policing the coronavirus outbreak: processes and prospects for collective disorder constructing hot spots policing: unexamined consequences for disadvantaged populations and for police legitimacy louisiana police apologize after using terrifying siren from the purge to start nightly curfew community policing, coproduction, and social control: restoring police legitimacy new challenges to police legitimacy the role of procedural justice and legitimacy in shaping public support for policing viewing things differently: the dimensions of public perceptions of police legitimacy a multidimensional model of police legitimacy: a cross-cultural assessment three pillars of police legitimacy: procedural justice, use of force, and occupational culture mirage of police reform: procedural justice and police legitimacy popular legitimacy and the exercise of legal authority: motivating compliance, cooperation, and engagement key: cord-009667-8r8j0h08 authors: cao, bin; huang, yi; she, dan‐yang; cheng, qi‐jian; fan, hong; tian, xin‐lun; xu, jin‐fu; zhang, jing; chen, yu; shen, ning; wang, hui; jiang, mei; zhang, xiang‐yan; shi, yi; he, bei; he, li‐xian; liu, you‐ning; qu, jie‐ming title: diagnosis and treatment of community‐acquired pneumonia in adults: 2016 clinical practice guidelines by the chinese thoracic society, chinese medical association date: 2017-09-26 journal: clin respir j doi: 10.1111/crj.12674 sha: doc_id: 9667 cord_uid: 8r8j0h08 community‐acquired pneumonia (cap) in adults is an infectious disease with high morbidity in china and the rest of the world. with the changing pattern in the etiological profile of cap and advances in medical techniques in diagnosis and treatment over time, chinese thoracic society of chinese medical association updated its cap guideline in 2016 to address the standard management of cap in chinese adults. extensive and comprehensive literature search was made to collect the data and evidence for experts to review and evaluate the level of evidence. corresponding recommendations are provided appropriately based on the level of evidence. this updated guideline covers comprehensive topics on cap, including aetiology, antimicrobial resistance profile, diagnosis, empirical and targeted treatments, adjunctive and supportive therapies, as well as prophylaxis. the recommendations may help clinicians manage cap patients more effectively and efficiently. cap in pediatric patients and immunocompromised adults is beyond the scope of this guideline. this guideline is only applicable for the immunocompetent cap patients aged 18 years and older. the recommendations on selection of antimicrobial agents and the dosing regimens are not mandatory. the clinicians are recommended to prescribe and adjust antimicrobial therapies primarily based on their local etiological profile and results of susceptibility testing, with reference to this guideline. the revision of the guideline was initiated by chinese thoracic society (cts) and chinese medical association (cma). the overall framework and main content of the updated guideline were finalized following 3 face-to-face work meetings and 2 online video conferences. the experts specialized in methodology provided training on standardized literature search and grading of evidence to all the specialists contributing to the guideline. level of evidence and grading of recommendation were based on the infectious diseases society of america/american thoracic society (idsa/ats) guidelines for cap (2007) . 1 the level of evidence represents the assessment on the quality of study evidence, and the grading of recommendation refers to the assessment on the degree to which the benefits of an intervention outweighs the risks. generally speaking, the higher the evidence level, the stronger the grade of recommendation, but they do not fully correspond to each other. the willingness and values of patients, as well as resource consumption should also be considered when making a recommendation (table 1) . this guideline document is composed of 8 sections. the core panel members are responsible for 8 separate groups to prepare the first draft by searching and reviewing the relevant domestic and international literature, evaluating evidence level with the unified standard. the grading of recommendations is decided by vote of all members participating in the preparation of the guidelines. the principal writer was responsible for summarization and modification of the first draft. in the process, 6 face-toface work meetings were held to discuss revision of the draft. three rounds of consultation were conducted to solicit advice and opinions from the specialists of the specialty groups within cts, cma, specialists in relevant disciplines the distribution and antimicrobial resistance profile of cap pathogens are significantly different across different countries and regions, and change over time. currently, the results of several epidemiological surveys of cap conducted in level i (high) evidence from well-designed, randomized, controlled trials (rcts), authoritative guidelines and high quality systematic reviews and meta-analyses level ii (moderate) evidence from rcts with some limitations (eg, trials without allocation concealment, nonblinded, or loss to follow-up not reported), cohort studies, case series and case-control studies level iii (low) evidence from case reports, expert opinions and in vitro antimicrobial susceptibility studies without clinical data grade of recommendation a (strong) most patients, physicians and policy makers will adopt the recommended action. the recommendation will be adopted by the majority, but not by some individuals. decisions should be made with consideration of the specific condition of the patient to reflect his/her values and willingness. c (weak) insufficient evidence; decisions must be made via mutual discussions involving the patients, physicians and policy makers. chinese adults have shown that mycoplasma pneumoniae and streptococcus pneumoniae are important pathogens of cap in adults in china. [13] [14] [15] [16] [17] other common pathogens include haemophilus influenzae, chlamydia pneumoniae, klebsiella pneumoniae and staphylococcus aureus; but pseudomonas aeruginosa and acinetobacter baumannii are infrequently isolated. 13, [16] [17] [18] in china, only a small number of cases of community-acquired methicillin-resistant s. aureus (ca-mrsa) pneumonia are reported in children and teenagers. [19] [20] [21] [22] ca-mrsa was not identified in the antimicrobial resistance surveillance of community-acquired respiratory tract pathogens in adults conducted in 2009-2010. 23 for special populations such as elderly patients or patients with underlying diseases (eg, congestive heart failure, cardiovascular or cerebrovascular diseases, chronic respiratory system diseases, kidney failure and diabetes mellitus), gramnegative bacteria such as k. pneumoniae and escherichia coli are more common. 18, 24, 25 with the development and application of virus detection technology, the role of respiratory tract viruses is gradually gaining attention in the aetiology of cap in chinese adults. the results of several recently published multicenter studies showed that the detection rate of viruses was 15%-34.9% in chinese adult cap patients, of which influenza virus accounted for the largest proportion. other contributing viruses included parainfluenza virus, rhinovirus, adenovirus, human metapneumovirus (hmpv) and respiratory syncytial virus (rsv). among the patients with positive test results for viruses, 5.8%-65.7% could have concomitant infection caused by bacteria or atypical pathogens. 15, 18, 26, 27 considering the resistance profile of major pathogens, the high percentage of s. pneumoniae resistant to macrolides found in chinese adult cap patients is an important characteristic that differs from that in european and american countries. two nation-wide multicenter surveys on adult cap conducted in [2003] [2004] [2005] showed that 63.2%-75.4% of s. pneumoniae isolates were resistant to macrolides. 13, 17 recently, the results of 2 multicenter community-acquired respiratory tract infection pathogen surveillance (car-tips) studies in adults conducted in urban tertiary hospitals in china showed that 88.1%-91.3% of s. pneumoniae isolates were resistant to azithromycin, the minimum inhibitory concentration of which required to inhibit the growth of 90% of organisms (mic 90 ) was 32-256 mg/l and 88.2% of the isolates were resistant to clarithromycin. 23, 28 while in european and american countries, 12.9%-39% and 4.3%-33.3% of s. pneumoniae isolates were resistant to erythromycin and azithromycin, respectively. [19] [20] [21] [22] [23] [24] [25] [26] [27] [28] [29] [30] [31] [32] [33] [34] moreover, 24.5%-36.5% of s. pneumoniae isolates were resistant to oral penicillins, and 39.9%-50.7% resistant to second-generation cephalosporins in china. however, relatively low percentage of s. pneumoniae isolates were resistant to injectable penicillins and third-generation cephalosporins (1.9% and 13.4%, respectively). 23, 28 the high percentage of mycoplasma pneumoniae strains resistant to macrolides is another important characteristic in the aetiology of cap in china, which is different from that in most other countries. study results showed that 58.9%-71.7% of the mycoplasma strains isolated from chinese adult cap patients were resistant to erythromycin, and 54.9%-60.4% resistant to azithromycin. [35] [36] [37] the infections caused by antibiotic-resistant mycoplasma may prolong the duration of fever and anti-infective treatment. 36 in addition to china, 25%-46% of the mycoplasma strains isolated from japanese adult and teenage cap patients were resistant to macrolides. macrolides-resistant m. pneumoniae was also reported in france, canada, the united states, spain and germany. [38] [39] [40] [41] [42] [43] m. pneumoniae is highly resistant to macrolides in china, but it remains susceptible to doxycycline, minocycline and quinolones. 35, 44 a. onset in community. b. relevant clinical manifestations of pneumonia: (1) new onset of cough or expectoration, or aggravation of existing symptoms of respiratory tract diseases, with or without purulent sputum, chest pain, dyspnea, or hemoptysis; (2) fever; (3) signs of pulmonary consolidation and/or moist rales; (4) peripheral white blood cell count (wbc) > 10 3 10 9 /l or < 4 3 10 9 /l, with or without a left shift. c. chest radiograph showing new patchy infiltrates, lobar or segmental consolidation, ground-glass opacities, or interstitial changes, with or without pleural effusion. clinical diagnosis can be established if a patient satisfies criterion a, criterion c and any one condition of criterion b and meanwhile, tuberculosis, pulmonary tumour, noninfectious interstitial lung disease, pulmonary edema, atelectasis, pulmonary embolism, pulmonary eosinophilia and pulmonary vasculitis are all excluded. step 1: determine whether a diagnosis of cap is valid or not. for patients with clinically suspected cap, the possibility of unusual infections such as tuberculosis and noninfectious causes must be considered. step 2: evaluate the severity of cap and select the location for treatment. step 3: predict the potential pathogens of cap and risks of antibiotic resistance ( table 2) : considering patient age, season of onset, underlying diseases and risk factors, symptoms or signs, characteristics of chest imaging (x-ray film or ct), laboratory tests, severity of cap, prior antibacterial therapies and so on. step 4: arrange for reasonable etiological tests, and initiate empirical anti-infective treatment in a timely manner. step 5: evaluate the effectiveness of empirical antiinfective treatment on cap in a dynamic manner; investigate the cause if initial treatment fails, and adjust treatment protocol promptly. step 6: follow up after treatment; and provide education on health maintenance. cap s ev eri ty, c ri ter ia f or hos p i ta l adm i s s io n and di agno s ti c cr it eri a f or s the evaluation of cap severity is crucial for selection of appropriate location of treatment, initial empirical antimicrobial agents, as well as adjunctive and supportive treatments. the scoring systems of cap severity differ from each other ( table 3) . they can be used as an aid for evaluation and provide support for clinical diagnosis and treatment, but physicians should take clinical experience into consideration when making judgments, and monitor disease progression in a dynamic manner 56 (ii a). curb-65, crb-65 (c: disturbance of consciousness, u: urea nitrogen, r: respiratory rate, b: blood pressure, 65: age), and pneumonia severity index (psi) scoring systems underestimate the risk of death and severity of influenza pneumonia, 57-60 while oxygenation index combined with absolute reduction of peripheral blood lymphocyte is superior to curb-65 and psi in predicting the risk of death due to influenza pneumonia 61 (ii b). curb-65 score is recommended as a standard for deciding whether a patient should be hospitalized or not. a score of 0-1 point: theoretically, patients should receive outpatient treatment; a score of 2 points: patients are recommended to receive inpatient treatment or extramural treatment with close follow-up; a score of 3-5 points: patients should be hospitalized (i a) . however, other factors such as patient age, underlying diseases, socioeconomic status, gastrointestinal functions and treatment compliance should also be taken into account for comprehensive evaluation 62 (ii b). criteria for diagnosis of severe cap 63 : patients who meet any of the major criteria or 3 minor criteria could be diagnosed as severe pneumonia and need close monitoring and active treatment; it is also recommended that the patients should be hospitalized in icu if applicable (ii a). acute onset, high fever with potential shivers, purulent sputum, brown bloody sputum, chest pain, significant increase in peripheral wbc, increased c-reactive protein (crp), signs of pulmonary consolidation or moist rales; radiograph shows alveolar infiltrates or lobar or segmental distribution of consolidation. [45] [46] [47] [48] [49] mycoplasma or chlamydia under 60 years of age, with few underlying diseases; continuous cough, no sputum or no bacteria discovered in sputum smear test, few pulmonary signs, peripheral wbc <10 3 10 9 /l; radiograph may show lesions in the upper lung field of both lungs, centrilobular nodules, tree-in-bud sign, ground-glass opacities, or thickening of bronchial wall and may show signs of consolidation with disease progression. 15, 46, [50] [51] [52] virus mostly seasonal, may have history of exposure to an epidemic or clustered outbreak, acute upper respiratory tract symptoms, myalgia, normal or decreased peripheral wbc, procalcitonin (pct) < 0.1 ng/ml, unresponsive to treatment with antibacterial agents; radiograph shows bilateral, interstitial exudates in multiple lobes and/or ground-glass opacities, which may be accompanied by consolidation. 46, [53] [54] [55] iv. patients without improvement after active anti-infective therapies, who require differential diagnosis with non-infectious pulmonary lesions (such as tumour, vasculitis and interstitial lung disease) (iii b). see table 5 for the primary testing methods for cap pathogens and their corresponding diagnostic criteria. 6 | s ecti on 4 . anti -i nf ect i ve ther ap i es f or c ap after clinical diagnosis of cap is established, and etiological test and sampling arranged appropriately, the most potential pathogens should be assessed in terms of patient age, underlying disease, clinical characteristics, results of laboratory and radiography tests, severity of disease, hepatic and renal functions, and history of medication and antimicrobial susceptibility profile, then evaluate the risk for antibiotic resistance, select the appropriate anti-infective agent (s) and dosing regimen ( table 6 ). the initial empirical antibacterial therapy should be administered promptly. it is important to note that the epidemiological distribution and antimicrobial resistance profile of pathogens may be different in different regions of china. the anti-infective drugs listed in table 6 are optional for initial empirical therapy. the treatment recommendations are only theoretical. the selection of therapies for specific patients must be based on the actual situation in local healthcare facilities. additionally, the pharmacokinetic and pharmacodynamic properties of antibacterial agents must be taken into consideration. for time-dependent antibacterial agents (such as penicillins, cephalosporins, monobactams and carbapenems), their bactericidal ability is almost saturated at 4-5 times of mic, 115 and t > mic (time above mic) is an important determinant of efficacy. 116 better clinical efficacy can be achieved by multiple doses per day based on half-lives. meanwhile, the bactericidal ability of concentrationdependent antibacterial agents, such as aminoglycosides and quinolones, increases with drug concentration. the effect improves with higher peak drug concentration. 116 therefore, these drugs are usually administered once daily in order to increase drug activity and decrease the risk of drug resistance and kidney injury caused by aminoglycosides. recommendations of this guideline for empirical antiinfective treatment of cap are provided in the following. 1. the first dose of anti-infective agent should be used as early as possible after diagnosis of cap is established in 1. fluorescent smear microscopy is more sensitive than ziehl-neelsen staining 85, 86 2. the sensitivity of mycobacteria culture is superior to that of smear microscopy; in vitro susceptibility testing can be performed, but it is more timeconsuming and complex, and has a higher biological safety requirement for laboratories 85 order to improve efficacy and decrease mortality and hospital stay. however, it is important to note that a correct diagnosis is a prerequisite. physicians should not ignore necessary differential diagnosis for the purpose of early diagnosis [117] [118] [119] [120] 8. anti-infective therapy can usually be terminated 2-3 days after fever is relieved and the primary respiratory tract symptoms are improved significantly. however, the duration of therapy should differ based on the severity of disease, treatment response, complications and pathogens. it is not necessary to use chest x-ray or ct as an indication of termination of anti-bacterial agents. generally, the duration of therapy should be 5-7 days for patients with mild or moderate cap, which could be reasonably prolonged for patients with severe cap or with extra-pulmonary complications. the duration of therapy can be prolonged to 10-14 days for patients with atypical pathogens and/or slow response to treatment. s. aureus, p. aeruginosa, klebsiella and anaerobic bacteria may cause necrosis of lung tissues, therefore, the duration of therapy may be prolonged to 14-21 days 1,2,122,156-159 (i b). once aetiology of cap is determined, targeted therapies can be delivered according to the results of in vitro susceptibility testing. see table 7 for common pathogens of cap, common anti-infective agents, as well as dosage and administration. cap is the primary cause of death among infectious diseases. in addition to anti-infective treatment targeting the pathogens, it is also necessary for patients with moderate or severe cap to receive adjunctive therapies such as rehydration, maintenance of fluid and electrolyte balance, nutrition support and physical therapy 2 (ii b). for patients with concomitant low blood pressure, early fluid resuscitation is an important measure to decrease the mortality of serious cap 1,168 (ii b). for patients with hypoxemia, oxygen (2) repeated doses of antibacterial drugs or glucocorticoids due to chronic airway disease. combination therapy is recommended for patients with severe cap or proven antimicrobial resistance i generation cephalosporins: cefazolin, cefradine, cephalexin, cefathiamidine and so on. ii generation cephalosporins: cefuroxime, cefamandole, cefotiam, cefaclor, cefprozil, and so on. iii generation cephalosporins: intravenous: ceftriaxone, cefotaxime, ceftizoxime and so on; oral: cefdinir, cefixime, cefpodoxime proxetil, cefditoren pivoxil and so on. respiratory quinolones: levofloxacin, moxifloxacin, gemifloxacin. aminopenicillins: amoxicillin, ampicillin. penicillins-b-lactamase-inhibitor combinations (not including penicillins with antipseudomonal activity, such as piperacillin, ticarcillin): amoxicillin-clavulanic acid, amoxicillin-sulbactam, ampicillinsulbactam and so on. macrolides: azithromycin, clarithromycin, erythromycin. quinolones with antipseudomonal activity: ciprofloxacin, levofloxacin. beta-lactams with antipseudomonal activity: ceftazidime, cefepime, aztreonam, piperacillin, piperacillin-tazobactam, ticarcillin, ticarcillin-clavulanic acid, cefoperazone, cefoperazone-sulbactam, imipenem-cilastatin, meropenem, panipenem-betamipron, biapenem. weeks; followed by tmp-smx for 3-4 months the duration of therapy is 3-4 months for primary pulmonary nocardiosis. ampicillin 2 g iv q8h, for 4-6 weeks, followed by penicillin v potassium 2-4 g/kg per day, oral, for piperacillin; amoxicillin-clavulanic acid; ampicillin-sulbactam; piperacillin-tazobactam; doxycycline; minocycline; ceftriaxone; clindamycin; chloramphenicol; azithromycin; erythromycin; moxifloxacin; imipenem; ertapenem penicillin g is an alternative to ampicillin: 10-20 million u/d, iv, divided into 4-6 separate doses, for 4-6 weeks. gentamicin 5 mg/kg iv once daily doxycycline; minocycline tmp-smx can be used to prevent yersinia pestis pneumonia. chloramphenicol is effective but with high toxicity. cephalosporins and quinolones are effective in animal models. ciprofloxacin 400 mg iv q12h or levofloxacin 500 mg iv once daily or doxycycline 100 mg iv q12h 1 clindamycin 900 mg iv q8h 6 rifampin 300 mg iv q12h; switch to oral therapy and reduce dosage after improvement: ciprofloxacin 500 mg oral, twice daily; clindamycin 450 mg oral, q8h, and rifampin 300 mg oral, twice daily. duration of therapy is 60 d. penicillin g clindamycin can inhibit the production of toxins. rifampin can enter cerebrospinal fluid and into cells. if the isolated pathogen is susceptible to penicillin, penicillin 4 million u iv q4h should be given. if structural or inductive b-lactamase is produced, penicillin or ampicillin should not be used alone. cephalosporins or tmp-smx should not be used. erythromycin and azithromycin have borderline activity. clarithromycin is effective. moxifloxacin is effective, but without clinical data. cidofovir 1 mg/kg iv once daily 3 2 weeks, and oral probenecid 2 g should be given every time before injection. and 1 g oral probenecid should the drug is contraindicated when serum creatinine >1.5 mg/dl, crcl 55 ml/min, or urine protein 100 mg/l. no specific drug so far ribavirin 0.5-1 g/d iv q12h (not recommended for regular use) therapies are mainly symptomatic treatments, including fluid replacement and oxygen therapy. no specific drug so far therapy and assisted ventilation are also important to improve the outcomes of patients. additionally, nebulization, postural drainage and chest physical therapy are also used in cap treatment [169] [170] [171] (ii b) . adjunctive drugs for severe cap also include glucocorticoids, intravenous immune globulin and statins, although currently there is no conclusive evidence for their effectiveness 172 (ii b). 7.1 | oxygen therapy and assisted respiration 1. the blood oxygen level of hospitalized cap patients should be evaluated in a timely manner. oxygen therapy via nasal catheter or face mask is recommended for patients with hypoxemia in order to maintain blood oxygen saturation at above 90%. additionally, for patients with risk of hypercapnia, oxygen saturation should be maintained at 88%-92% before obtaining the results of blood gas analysis 173, 174 (iii a). the results of recent studies showed that heated and humidified high-flow oxygen therapy via nasal catheter (40-60 l/min) could also be used in clinical practice 175, 176 (ii b). 2. compared with high-concentration oxygen therapy, noninvasive ventilation (niv, including bilevel positive airway pressure or continuous positive pressure ventilation) can decrease the endotracheal intubation rate and mortality of cap patients with acute respiratory failure, [177] [178] [179] [180] [181] improve oxygenation index faster and more significantly, 177, 178, 182, 183 and decrease the incidence of multiple organ failure, 179 and septic shock. 177 these benefits are more significant for patients with concomitant chronic obstructive pulmonary disease 180 (ii b). however, for cap patients with acute respiratory distress syndrome (ards), niv has shown high failure rate 184 and it cannot improve prognosis. 177 niv is also not appropriate for cap patients with severe hypoxemia (oxygenation index < 150 mm hg) 184 (ii a) . additionally, the failure of niv must be recognized timely. niv failure is indicated if niv cannot improve respiratory rate or oxygenation state within the initial 1-2 h, 180, 184, 185 or the therapy cannot decrease the blood carbon dioxide level in a patient with initial hypercapnia. 180 the oxygen therapy should be switched to tracheal intubation and ventilator-assisted ventilation immediately (ii a). 3. mechanical ventilation with low tidal volume (6 ml/kg ideal body weight) should be used for cap patients with ards after tracheal intubation 186, 187 (i a) . 4. for patients with severe cap and concomitant ards, extracorporeal membrane oxygenation (ecmo) can be used if regular mechanical ventilation cannot lead to improvement [188] [189] [190] [191] (ii b). indications of ecmo include: (1) reversible respiratory failure associated with severe the selection of antimicrobial agents should ultimately depend on susceptibility testing results and the opinions of local microbiological specialists. the appropriate dosage of antimicrobial agents should be based on local data. crcl, creatinine clearance; mic, minimum inhibitory concentration; mrsa, methicillin-resistant s. aureus; tmp-smx, trimethoprim-sulfamethoxazole. a cefoxitin 1-2 g iv q8h-q6h; cefmetazole 1-2 g q8h-q12h; cefotetan 1-3 g iv q12h (maximum dose 6 g once daily); cefminox 1 g iv q8h. b levofloxacin, moxifloxacin, gemifloxacin (not as first-line therapy for penicillin-susceptible strains); ciprofloxacin is mainly used in treatment of gram-negative bacteria (including h. influenzae). c ticarcillin 3 g iv q4h-q6h; piperacillin 2-4 g iv q4h-q6h; piperacillin-tazobactam 4.5 g iv q6h-q8h; aztreonam 1-2 g iv q8h-q12h; ceftazidime 1-2 g iv q8h-q12h; cefepime 1-2 g iv q8h-q12h; cefoperazone 1-2 g iv q8h; cefoperazone-sulbactam (2:1) 3 g q8h-q12h; imipenem-cilastatin (for p. aeruginosa) 500 mg (based on imipenem) iv q6h-q8h; meropenem 1-2 g iv q8h; panipenem-betamipron 1-2 g iv q8h-q12h; biapenem 0. piperacillin-tazobactam 4.5 g iv q6h-q8h; ticarcillin-clavulanic acid 3.2 g iv q6h-q8h; ampicillin-sulbactam 1.5-3 g iv q6h or amoxicillin-clavulanic acid 1.2 g iv q8h-q12h. f imipenem-cilastatin 500 mg (based on imipenem) iv q6h-q8h; meropenem 1-2 g iv q8h; ertapenem 1-2 g iv q24h; panipenem-betamipron 1-2 g iv q8h-q12h; biapenem 0.3 g iv q12h. glucocorticoids can decrease the mortality of cap patients complicated with septic shock. [193] [194] [195] hydrocortisone succinate 200 mg/day is suggested based on the treatment of septic shock. 196 the drug should be stopped promptly after septic shock is corrected. the duration of therapy is normally no more than 7 days (ii c the initial therapy is assessed as effective or failure based on the patient's response to treatment, and subsequent management is provided accordingly. assessment after initial therapy should include the following 5 aspects: 1. clinical manifestations: including respiratory and systemic symptoms and signs (iii a). 2. vital signs: general condition, consciousness, body temperature, respiratory rate, heart rate, blood pressure and so on. 2 (i a). 3. general laboratory tests: including routine blood test, blood biochemistry, blood gas analysis, c-reactive protein, procalcitonin and so on. it is recommended to repeat c-reactive protein, procalcitonin and routine blood tests after 72 h for hospitalized patients in order to differentiate between treatment failure and slow response to therapy. patients with severe conditions should be monitored closely 2,206-209 (ii b). microbiological tests: it is appropriate to repeat regular microbiological tests. molecular biological and serological assays can be used when necessary. efforts should be made to obtain etiological evidence [210] [211] [212] [213] [214] [215] [216] [217] [218] [219] [220] (ii b). chest radiography: it is not recommended to repeat chest radiography regularly for patients with significant improvement in clinical symptoms. when symptoms and signs persist or exacerbate, chest x-ray or chest ct should be repeated to identify the changes of lung lesions 2 (i a). 1. an effective initial therapy is defined as the situation that the clinical condition of a patient is stabilized after therapy. all the 5 criteria below must be met for clinical stability: (1) 2. subsequent management is recommended after an effective initial therapy: (1) for patients with significant improvement in symptoms after initial therapy, it is appropriate to continue the same anti-infective treatment (i a). (2) for patients who have achieved clinical stability and are able to receive oral therapy, sequential therapy should be administered with pathogen-susceptible oral preparations of the same types of antimicrobial agents or another agent with similar antibacterial spectrum 1,222 (i a). 1. a failed initial therapy is defined as either of the following situations in a patient: the symptoms are not improved after initial therapy, and requiring alternative antibiotics; exacerbation and disease progression after initial improvement during initial therapy (ii a). the epidemic season is from february to may. the virus is commonly seen in adults without underlying disease. 26 the incubation period is 3-8 d. hadv-55, hadv-11 and hadv-7 are relatively common serotypes 259, 260 similar to pneumonia caused by influenza virus; more common in immunocompetent adults [259] [260] [261] [262] patients with severe conditions primarily show pulmonary consolidation, which may be associated with ground-glass opacities or patchy nodule infiltrates in unilateral or bilateral lungs or multiple lobes 259 [273] [274] [275] and use of tumour necrosis factor-a antagonists. 277 the relevant epidemiological history includes contact with contaminated air conditioners, air conditioner cooling tower, or contaminated potable water, hot recreational spa, gardening activities or plumbing repairs and the history of traveling to an area with legionella outbreak. 2, 275, 276, 278 the possibility of legionella pneumonia should be suspected when an adult cap patient develops the following conditions: fever but relative bradycardia, acute onset of headache, non-drug-induced disturbance of consciousness or sleepiness, non-drug-induced diarrhoea, acute renal and/or hepatic impairment, hyponatremia, hypophosphatemia and unresponsiveness to b-lactams. 164, 276, [278] [279] [280] [281] [282] [283] the relatively specific manifestations of legionella pneumonia in chest radiograph is sharply demarcated consolidation intermingled with ground-glass opacities. another characteristic of legionella pneumonia is radiographic progression within a short period of time (1 week) even though improvement in clinical symptoms. or it may take several weeks or even months for pulmonary infiltrates to be completely absorbed. [284] [285] [286] macrolides, respiratory quinolones or doxycycline monotherapy are appropriate for immunocompetent patients with mild or moderate legionella pneumonia. quinolones combined with rifampin or macrolides are recommended for patients with severe conditions, or when monotherapy fails and those immunocompromised patient 1, 2, [287] [288] [289] [290] (i a) . when quinolones are combined with macrolides, physicians should pay close attention to the potential risk of abnormalities in cardiac electrophysiology 2 (i a). currently, ca-mrsa pneumonia is relatively rare in mainland china. only a small number of cases are reported in children and teenagers. [19] [20] [21] [22] similarly, among the skin and soft tissue infections caused by s. aureus, mrsa only accounts for a small proportion (5/164). 291 among the pathogens of hospitalized cap patients, the proportion of mrsa is 4.3% in taiwan, 292 3.3% in japan 293 and 6.2%-8.9% in the united states according to a survey. 294 the estimated incidence of ca-mrsa pneumonia is 0.51-0.64/100 000 268, 269 mainly pulmonary involvement in subpleural and basal segments of lungs; broad appearance of ground-glass opacities, which may be associated with consolidation. pleural effusion, interlobular septal thickening may also appear 269, 270 ribavirin combined with interferon 168, 271 (ii c) people. 295 ca-mrsa pneumonia is a severe disease associated with mortality up to 41.1%. 296 vulnerable populations include patients or individuals with close contact with a mrsa carrier or patient, individuals affected by influenza virus, prisoners, professional athletes, individuals who serve in the army recently, men who have sex with men, intravenous drug users, regular sauna users and those using antibacterial agents before infection. 295 ca-mrsa pneumonia progresses rapidly. the clinical symptoms include influenza-like symptoms, 296,297 fever, cough, chest pain, gastrointestinal symptoms and skin rashes. for patients with serious conditions, severe pneumonia symptoms such as hemoptysis, confusion, ards, multiple organ failure and shock may appear, as well as complications such as acidosis, disseminated intravascular coagulation, deep vein thrombosis, pneumothorax or empyema, pneumatocele, pulmonary abscess and acute necrotic pneumonia. 295 radiographic characteristics of ca-mrsa pneumonia include extensive pulmonary consolidation and multiple cavities in bilateral lungs. 298 ca-mrsa pneumonia should be suspected after influenza or in previously healthy young patients in case of cavitation, necrotic pneumonia associated with rapid increase of pleural effusion, massive hemoptysis, neutropenia and/or erythematous rashes. 299 glycopeptides or linezolid are the primary choice for ca-mrsa pneumonia 1,299 (iii b). currently, the consensus definition of cap in the elderly (elderly cap) is pneumonia occurring in the population aged 65 years. 2, 300, 301 the incidence of elderly cap increases with age. the clinical manifestations of elderly cap can be atypical. 302, 303 the manifestations may only include poor appetite, urinary incontinence, tiredness and altered mental state and so on. 2, 301 typical manifestations of pneumonia such as fever, cough and increased wbc/neutrophil count may not be so evident. 303 therefore, missed diagnosis and misdiagnosis may occur. tachypnea is a sensitive index for diagnosis of elderly cap. 304 when fever or any of the abovementioned atypical symptoms appear, chest radiography should be done as early as possible to confirm the diagnosis. 304 s. pneumoniae is still the main pathogen for elderly cap, but the possibility of enterobacteriaceae infection should be considered for elderly patients with underlying diseases (congestive heart failure, cardiovascular and cerebrovascular diseases, chronic respiratory system diseases, renal failure, diabetes mellitus, etc.). 24,300,305 these patients should be further evaluated for risk factors of esbls-producing enterobacteriaceae. empirical treatment with cephamycins, piperacillin-tazobactam, cefoperazone-sulbactam, ertapenem or other carbapenems is recommended for patients with high risk of infections with esbls-producing enterobacteriaceae [145] [146] [147] 306 (iii b) . relevant risk factors include history of esbls-producing bacterial colonization or infection, prior use of third generation cephalosporins, history of repeated or long-term hospitalization, indwelling medical devices, renal replacement therapies. [142] [143] [144] elderly patients are associated with reduced organ functions, which must be monitored during treatment to avoid side effects. reduced renal excretion may cause prolonged half-lives of drugs, so the dosage should be reasonably adjusted in terms of crcl when treating such patients 304 (ii b). if no contraindication exists, hospitalized elderly cap patients should be evaluated for risk of deep vein thrombosis and prophylaxis with low molecular weight heparin should be administered when necessary 307 (ii b). the treatment failure rate is 6%-15% for elderly cap. 308 common reasons are concomitant severe sepsis, myocardial infarction, or progression of pneumonia. 309 cardiovascular event is common in elderly cap, which is one of the reasons for increased mortality. 308,309 aspiration pneumonia is pulmonary infectious lesions caused by aspiration of food, oropharyngeal secretion, or gastric content into the throat or lower respiratory tract, not including chemical inflammation in the lung due to aspiration of sterile gastric fluid. [310] [311] [312] the majority cases of aspiration pneumonia are caused by silent aspiration, accounting for around 71% of elderly cap. 312 the following points should be noted when making diagnosis of aspiration pneumonia: (1) whether there are risk factors for aspiration (eg, disturbance of consciousness due to cerebrovascular diseases or other reasons, dysphagia, periodontal diseases, or poor oral hygiene) 122,308,313-316 ; (2) whether chest radiograph shows primary lesions in the posterior segment of upper lobe and dorsal or basal segment of the lower lobe, just as in hypostatic pneumonia. 312, [317] [318] [319] aspiration pneumonia is mostly caused by infections with anaerobic bacteria, gram-negative bacteria or s. aureus. the treatment should cover the above pathogens and based on the severity of disease using antimicrobial agents with antianaerobic activity, such as amoxicillin-clavulanic acid, ampicillin-sulbactam, moxifloxacin, carbapenems or in combination with metronidazole or clindamycin 136, [139] [140] [141] 316, 320, 321 (ii a). targeted treatment can be administered after the results of sputum culture and antimicrobial susceptibility testing are available. intensive care is required for the elderly patients with risk factors of aspiration in order to reduce the incidence of aspiration pneumonia, specifically: (1) the head of bed should be elevated to 35-408 for long-term bedridden patients if there is no contraindication, and the patient should be in appropriate position when feeding the patient; (2) oral hygiene should be maintained to reduce bacterial colonization in the oropharyngeal area; (3) for elderly patients with severe dysphagia who have already experienced aspiration, physicians should evaluate the risks and benefits of nasal feeding via indwelling gastric tube; (4) antipsychotic drugs, antihistamines and anticholinergic agents should be avoided or decreased 135, 322, 323 (ii b). smoking cessation, 1 avoid excessive alcohol drinking, adequate nutrition and good oral health 324 are all helpful in preventing pneumonia (iii b). good hand hygiene habits should be maintained. during an episode of respiratory tract symptoms such as coughing or sneezing, wearing a mask or using tissues or elbow clothes to cover the nose and mouth can reduce the dissemination of respiratory tract pathogens 325 (iii a). vaccination against s. pneumoniae can reduce the risk of pneumonia in specific populations. the s. pneumoniae vaccines currently in use include pneumococcal polysaccharide vaccine (ppv) and pneumococcal conjugate vaccine (pcv). in china, 23-valent pneumococcal polysaccharide vaccine (ppv23) has been on the market. it can effectively prevent invasive s. pneumoniae infections. 326 ppv23 is recommended for the following populations (i b): (1) age 65 years; (2) age < 65 years, but with chronic pulmonary disease, chronic cardiovascular disease, diabetes mellitus, chronic renal failure, nephrotic syndrome, chronic hepatic disease (including hepatic cirrhosis), alcoholism, cochlear implant, cerebrospinal fluid leakage, immunodeficiency or functional or organic asplenia; (3) long-term residents in nursing homes or other medical institutions; (4) smokers. 327 for the above patients, one dose of vaccine by intramuscular or subcutaneous injection is recommended. usually, repeat vaccination is not advised for immunocompetent individuals, although it is appropriate for individuals under 65 years of age, but with chronic renal failure, nephrotic syndrome, functional or organic asplenia or immunodeficiency. there should be at least a 5-year interval between two doses of ppv23. repeat vaccination is not necessary for the individuals who are at least 65 years of age at the time of first vaccination (i b). the 13-valent pneumococcal conjugate vaccine (pcv13) can cover 70%-80% of s. pneumoniae serotypes in china, 328,329 associated with excellent immunogenicity, 330 but it has not been available in china market. pcv13 vaccination strategy: adults aged 65 years who have not received s. pneumoniae vaccination should receive 1 dose of pcv13, and 1 dose of ppv23 within 6-12 months afterward; adults aged 65 years who have received one or more doses of ppv23 should receive 1 dose of pcv13 at least one year after the latest dose of ppv23; adults who have received ppv23 before the age of 65 should receive pcv13 after 65 years old (at least one year after the last vaccination), and can repeat ppv23 vaccination at least 6-12 months later, but there should be at least a 5-year interval between the two doses of ppv23 331 (i b). influenza vaccines can prevent influenza or reduce influenza-associated symptoms. 332, 333 they also have some protective effects against influenza pneumonia and bacterial pneumonia secondary to influenza. 334 the target population of influenza vaccines is broader than that of s. pneumoniae vaccines. see the chinese guidelines for diagnosis and treatment of influenza 101 and visit the website for national influenza center 335 for details. one dose of influenza vaccine is recommended per annual influenza season 1 (i a). combination of pneumococcal vaccines with influenza vaccines can decrease mortality in elderly patients 336 (ii b). bin cao, yi huang drafting of section 2: qi-jian cheng drafting of section 3: dan-yang she infectious diseases society of america/american thoracic society consensus guidelines on the management of community-acquired pneumonia in adults bts guidelines for the management of community acquired pneumonia in adults: update community-acquired pneumonia requiring hospitalization among u.s. adults high incidence of community-acquired pneumonia among rapidly aging population in japan: a prospective hospital-based surveillance etiology and outcome of community-acquired pneumonia in relation to age and severity in hospitalized adult patients global and local epidemiology of community-acquired pneumonia: the experience of the cap-netz network a 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pneumonia vaccines for preventing influenza in healthy adults inactivated influenza vaccines for prevention of community-acquired pneumonia: the limits of using nonspecific outcomes in vaccine effectiveness studies guideline of seasonal influenza vaccination in china additive preventive effect of influenza and pneumococcal vaccines in the elderly: results of a large cohort study diagnosis and treatment of community-acquired pneumonia in adults: 2016 clinical practice guidelines by the chinese thoracic society, chinese medical association the following experts provided valuable opinions in the revision of these guidelines. their efforts are highly appreciated: writing group members: yusheng chen, xiangqun fang, zhancheng gao bin cao has been a speaker invited by pfizer, gsk and bayer. jie-ming qu has been a speaker on behalf of msd china, pfizer, bayer, daiichi sankyo and sanofi-aventis. all other authors declare no conflict of interests. li-xian he and you-ning liu contributed to be advisors; all authors contributed to critical revision and final approval of the manuscript. no ethics approval required. jing zhang http://orcid.org/0000-0001-5305-6233 key: cord-102749-tgka0pl0 authors: tovo, anna; menzel, peter; krogh, anders; lagomarsino, marco cosentino; suweis, samir title: taxonomic classification method for metagenomics based on core protein families with core-kaiju date: 2020-05-01 journal: biorxiv doi: 10.1101/2020.01.08.898395 sha: doc_id: 102749 cord_uid: tgka0pl0 characterizing species diversity and composition of bacteria hosted by biota is revolutionizing our understanding of the role of symbiotic interactions in ecosystems. however, determining microbiomes diversity implies the classification of taxa composition within the sampled community, which is often done via the assignment of individual reads to taxa by comparison to reference databases. although computational methods aimed at identifying the microbe(s) taxa are available, it is well known that inferences using different methods can vary widely depending on various biases. in this study, we first apply and compare different bioinformatics methods based on 16s ribosomal rna gene and whole genome shotgun sequencing for taxonomic classification to three small mock communities of bacteria, of which the compositions are known. we show that none of these methods can infer both the true number of taxa and their abundances. we thus propose a novel approach, named core-kaiju, which combines the power of shotgun metagenomics data with a more focused marker gene classification method similar to 16s, but based on emergent statistics of core protein domain families. we thus test the proposed method on the three small mock communities and also on mediumand highly complex mock community datasets taken from the critical assessment of metagenome interpretation challenge. we show that core-kaiju reliably predicts both number of taxa and abundance of the analysed mock bacterial communities. finally we apply our method on human gut samples, showing how core-kaiju may give more accurate ecological characterization and fresh view on real microbiomes. modern high-throughput genome sequencing techniques revolutionized ecological studies of microbial communities at an unprecedented range of taxa and scales (1, 2, 3, 4, 5) . it is now possible to massively sequence genomic dna directly from incredibly diverse environmental samples (3, 6) and gain novel insights about structure and metabolic functions of microbial communities. * correspondence should be addressed to dr. suweis. email: suweis@pd.infn.it one major biological question is the inference of the composition of a microbial community, that is, the relative abundances of the sampled organisms. in particular, the impact of microbial diversity and composition for the maintenance of human health is increasingly recognized (7, 8, 9, 10) . indeed, several studies suggest that the disruption of the normal microbial community structure, known as dysbiosis, is associated with diseases ranging from localized gastroenterologic disorders (11) to neurologic illnesses (12) . however, it is impossible to define dysbiosis without first establishing what normal microbial community structure means within the healthy human microbiome. to this purpose, the human microbiome project has analysed the largest cohort and set of distinct, clinically relevant body habitats (13) , characterizing the ecology of healthy human-associated microbial communities. however there are several critical aspects. the study of the structure, function and diversity of the human microbiome has revealed that even healthy individuals differ remarkably in the contained species and their abundances. much of this diversity remains unexplained, although diet, environment, host genetics and early microbial exposure have all been implicated. characterizing a microbial community implies the classification of species/genera composition within the sampled community, which in turn requires the assignment of sequencing reads to taxa, usually by comparison to a reference database. although computational methods aimed at identifying the microbe(s) taxa have an increasingly long history within bioinformatics (14, 15, 16) , it is well known that inference based on 16s ribosomal rna (rrna) or shotgun sequencing vary widely (17) . moreover, even if data are obtained via the same experimental protocol, the usage of different computational methods or algorithm variants may lead to different results in the taxonomic classification. the two main experimental approaches for analyzing the microbiomes are based on 16s rrna gene amplicon sequencing and whole genome shotgun sequencing (metagenomics). sequencing of amplicons from a region of the 16s rrna gene is a common approach used to characterize microbiomes (18, 19) and many analysis tools are available (see materials c 2020 the author(s) this is an open access article distributed under the terms of the creative commons attribution non-commercial license (http://creativecommons.org/licenses/ by-nc/2.0/uk/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. and methods section). besides the biases in the experimental protocol, a major issue with 16s amplicon-sequencing is the variance of copy numbers of the 16s genes between different taxa. therefore, abundances inferred by read counts of the amplicons should be properly corrected by taking into account the copy number of the different genera detected in the sample (3, 20, 21) . however, the average number of 16s rrna copies is only known for a restricted selection of bacterial taxa. as a consequence, different algorithms have been proposed to infer from data the copy number of those taxa for which this information is not available (18, 22) . in contrast, whole genome shotgun sequencing of all the dna present in a sample can inform about both diversity and abundance as well as metabolic functions of the species in the community (23) . the accuracy of shotgun metagenomics species classification methods varies widely (24) . in particular, these methods can typically result in a large number of false positive predictions, depending on the used sequence comparison algorithm and its parameters. for example in k-mer based methods as kraken (25) and kraken2 (26) the choice of k determines sensitivity and precision of the classification, such that sensitivity increases and precision decreases with increasing values for k, and vice versa. as we will show, false positive predictions often need to be corrected heuristically by removing all taxa with abundance below a given arbitrary threshold (see materials and methods section for an overview on different algorithms of taxonomy classification). we highlight that the protocols for 16s-amplicons and shotgun methods are different and each has their own batch effects. importantly, while shotgun taxonomic analysis gives classification results at species-level, 16s taxonomic profilers most often need to stop at the genus level. however, in the end, both aim at answering to the same question: "what are the relative abundances of taxa in the sample?" therefore it is not methodologically wrong to compare their answers against the same community. to do that, it is possible to aggregate lower level (e.g. species) counts towards higher levels (e.g. genus), as it has been done in many benchmarks studies before (see, e.g., (17, 25, 27, 28) ). in fact, several studies have performed comparisons of taxa inferred from 16s amplicon and shotgun sequencing data, with samples ranging from humans to studies of water and soil. logares and collaborators (29) studied communities of bacteria marine plankton and found that shotgun approaches had an advantage over amplicons, as they rendered more truthful community richness and evenness estimates by avoiding pcr biases, and provided additional functional information. chan et al. (30) analyzed thermophilic bacteria in hot spring water and found that amplicon and shotgun sequencing allowed for comparable phylum detection, but shotgun sequencing failed to detect three phyla. in another study (31) 16s rrna and shotgun methods were compared in classifying community bacteria sampled from freshwater. taxonomic composition of each 16s rrna gene library was generally similar to its corresponding metagenome at the phylum level. at the genus level, however, there was a large amount of variation between the 16s rrna sequences and the metagenomic contigs, which had a ten-fold resolution and sensitivity for genus diversity. more recently jovel et al. (27) compared bacteria communities from different microbiomes (human, mice) and also from mock communities. they found that shotgun metagenomics offered a greater potential for identification of strains, which however still remained unsatisfactory. it also allowed increased taxonomic and functional resolution, as well as the discovery of new genomes and genes. while shotgun metagenomics has certain advantages over amplicon-sequencing, its higher price point is still prohibitive for many applications. therefore amplicon sequencing remains the go-to established cost-effective tool to the taxonomic composition of microbial communities. in fact, the usage of the 16s rrna-gene as a universal marker throughout the entire bacterial kingdom made it easy to collect sequence information from a wide distribution of taxa, which is yet unmatched by whole genome databases. several curated databases exist to date, with silva (32, 33), greengenes (34, 35) and ribosomal database project (rdp) (36) being the most prominent. additionally, ncbi also provides a curated collection of 16s reference sequences in its targeted loci project (https://www.ncbi.nlm.nih.gov/refseq/targetedloci/). when benchmarking protocols for taxonomic classification from real samples of complex microbiomes, the "ground truth" of the contained taxa and their relative abundances is not known (see (27) ). therefore, the use of mock communities or simulated datasets remains as basis for a robust comparative evaluation of a method prediction accuracy. in the first part of this work we apply three widely used taxonomic classifiers for metagenomics, kaiju (28), kraken2 (26) and metaphlan2 (37) , and two common methods for analyzing 16s-amplicon sequencing data, dada2 (38) and qiime2 (39) to three small mock communities of bacteria, of which we know the exact composition (27) . we show that 16s rrna data efficiently allow to detect the number of taxa, but not their abundances, while shotgun metagenomics as kaiju and kraken2 give a reliable estimate of the most abundant genera, but the nature of the algorithms makes them predict a very large number of false-positive taxa. the central contribution of this work is thus to develop a method to overcome the above limitations. in particular, we propose an updated version of kaiju, which combines the power of shotgun metagenomics data with a more focused marker gene classification method, similar to 16s rrna, but based on core protein domain families (40, 41, 42, 43) from the pfam database (44) . our criterion for choosing the set of marker domain families is that we uncover the existence of a set of core families that are typically at most present in one or very few copies per genome, but together cover uniquely all 8116 bacteria species in the pfam database with an overall quite short sequence. using presence of these core pfams (mostly related to ribosomal proteins) as a filter criterion allows for detecting the correct number of taxa in the sample. we tested our approach in a protocol called "core-kaiju" and show that it has a higher accuracy than other classification methods not only on the three small mock communities, but also on intermediate and highly biodiverse mock communities designed for the 1st critical assessment of metagenome interpretation (cami) challenge (45) . in fact we will show how in all these cases core-kaiju overcomes, for the most part, the problem of false-positive genera and accurately predicts the abundances of the different detected taxa. we finally apply our novel pipeline to classify microbial genera in the human gut from the human macrobiome project (hmp) (46) dataset, showing how core-kajiu may allow for a more accurate biodiversity characterization of real microbial communities, thus putting the basis for more solid dysbiosis analysis in microbiomes. taxonomic classification: amplicon versus whole genome sequencing many computational tools are available for the analysis of both amplicon and shotgun sequencing data (25, 26, 28, 37, 38, 39, 47) . one of the differences among the several software for 16s rrna analysis, is on how the next-generation sequencing error rate per nucleotide is taken into account, when associating each sampled 16s sequence read to taxa. indeed, errors along the nucleotide sequence could lead to an inaccurate taxon identification and, consequently, to misleading diversity statistics. the traditional approach to overcome this problem is to cluster amplicon sequences into the so-called operational taxonomic units (otus), which are based on an arbitrary shared similarity threshold usually set up equal to 97% for classification at the genus level. of course, in this way, these approaches lead to a reduction of the phylogenetic resolution, since gene sequences below the fixed threshold cannot be distinguished one from the other. that is why, sometimes, it may be preferable to work with exact amplicon sequence variants (asvs), i.e. sequences recovered from a high-throughput marker gene analysis after the removal of spurious sequences generated during pcr amplification and/or sequencing techniques. the next step in these approaches is to compare the filtered sequences with reference libraries as those cited above. in this work, we chose to conduct the analyses with the following two opensource platforms: dada2 (38) and qiime2 (39) . dada2 is an r-package optimized to process large datasets (from 10s of millions to billions of reads) of amplicon sequencing data with the aim of inferring the asvs from one or more samples. once the spurious 16s rrna gene sequences have been recovered, dada2 allowed for the comparison with both silva, greengenes and rdp libraries. we performed the analyses for all the three possible choices. qiime2 is another widely used bioinformatic platform for the exploration and analysis of microbial data which allows, for the sequence quality control step, to choose between different methods. for our comparisons, we performed this step by using deblur (48) , a novel sub-operational-taxonomic-unit approach which exploits information on error profiles to recover error-free 16s rrna sequences from samples. as shown in (27) , where different amplicon sequencing methods are tested on both simulated and real data and the results are compared to those obtained with metagenomic pipelines, the whole genome approach resulted to outperform the previous ones in terms of both number of identified strains, taxonomic and functional resolution and reliability on estimates of microbial relative abundance distribution in samples. similar comparisons have also been performed with analogous results in (29, 30, 47, 49) (see (17) for a comprehensive summary of studies comparing different sequencing approaches and bioinformatic platforms). standard widespread taxonomic classification algorithms for metagenomics (e.g. kraken (25) and kraken2 (26) ) extract all contained k−mers (all the possible strings of length k that are contained in the whole metagenome) from the sequencing reads and compare them with index of a genome database. however, the choice of the length k highly influences the classification, since, when k is too large, it is easy not to found a correspondence in reference database, whereas if k is too small, reads may be wrongly classified. recently, a novel approach has been proposed for the classification of shotgun data based on sequence comparison to a reference database comprising protein sequences, which are much more conserved with respect to nucleotide sequences (28) . kaiju indexes the reference database using the borrows-wheeler-transform (bwt), and translated sequencing reads are searched in the bwt using maximum exact matches, optionally allowing for a certain number of mismatches via a greedy heuristic approach. it has been shown (28) that kaiju is able to classify more reads in real metagenomes than nucleotide-based k−mers methods. therefore, previous studies on the community composition and structure of microbial communities in the human can be actually very biased by previous metagenomic analysis that were missing up to 90% of the reconstructed species (i.e. most of the species they found were not present in the gene catalog). we therefore chose to work with kaiju (with mem option (28)) for our taxonomic analysis. although it resulted to give better estimates of sample biodiversity composition with respect to amplicon sequencing techniques, we found that it generally overestimates the number of genera actually present in our community (see results section) of two magnitude orders, i.e. there is a long tail of low abundant false-positive taxa. to overcome this, we implemented a new release of the program, core-kaiju, which contains an additional preliminary step where reads sequences are firstly mapped against a newly protein reference library we created containing the amino-acid sequence of proteomes' core pfams (see following section). we also compared standard kaiju and core-kaiju results with those obtained via kraken2 and via another widely used program for shotgun data analysis, metaphlan2 (37, 47) . after downloading the pfam database (version 32.0), we selected only bacterial proteomes and we tabulated the data into a f ×p matrix, where each column represented a different proteome and each row a different protein domain. in particular, our database consisted of p = 8116 bacterial proteomes and f = 11286 protein families. in each matrix entry (f,p), we inserted the number of times the f family recurred in proteins of the p proteome, n f,p . by summing up over the p column, one can get the proteome length, i.e. the total number of families of which it is constituted, which we will denote with l p . similarly, if we sum up over the f row, we get the family abundance, i.e. the number of times the f family appears in the pfam database, which we call a f . figure 1 shows the frequency histogram of the proteome sizes (left panel) and of the family abundances (right panel). our primary goal was to find the so-called core families (50), i.e. the protein domains which are present in the overwhelming majority of the bacterium proteomes but occurring just few times in each of them (41, 51) . in order to analyze the occurrences of pfam in proteomes, we converted the original f ×p matrix into a binary one, giving information on whether each pfam was present or not in each proteome. in the left panel of figure 2 we inserted the histogram of the family occurrences, which displays the typical u-shape, already observed in literature (43, 52, 53, 54) : a huge number of families are present in only few proteomes (first pick in the histogram), whilst another smaller peak occurs at large values, meaning that there are also a percentage of domains occurring in almost all the proteomes. in the right panel, we show the plot of the number of rare pfam (having abundance less or equal to four in each proteome) versus the percentage of proteomes in which they have been found. we thus selected the pfams found in more than 90% of the proteomes and such that max p n f,p = 4 (see zoom 2 panel of figure 2 ). since we wish to have at least one representative core pfam for each proteome in the database, we checked whether with these selected core families we could 'cover' all bacteria. unfortunately, none of them resulted to be present in proteomes 479430 and 1609106, corresponding to actinospica robiniae dsm 44927 and streptomyces sp. nrrl b-1568, respectively. we therefore looked for the most prevalent pfam(s) present in such proteomes. we found that pfam pf08338, occurring in 43% of the proteomes, was present in both actinospica robiniae and streptomyces and we therefore add it to our core-pfam list. eventually, in order to minimize the number of pfams to work with (and related computational cost), we considered in our final core-pfam list only the minimum number of domains through ribosomal protein l20 pf00572 ribosomal protein l13 pf01029 nusb family (involved in the regulation of rrna biosynthesis by transcriptional antitermination) pf01196 ribosomal protein l17 pf01649 ribosomal protein s20 (bacterial ribosomal protein s20 interacts with 16s rrna) pf01795 mraw methylase family (sam dependent methyltransferases) pf03947 ribosomal proteins l2, c-terminal domain pf08338 domain of unknown function (duf1731) pf09285 ef-p (elongation factor p) translation factor required for efficient peptide bond synthesis on 70s ribosomes pf17136 ribosomal proteins 50s l24/mitochondrial 39s l24 which we were able to cover the whole list of proteomes of the databases. in particular, the selected core protein domains for bacteria proteomes are the ten pfams pf00453, pf00572, pf01029, pf01649, pf01795, pf03947, pf08338, pf09285 and pf17136 (see table 1 ). principal coordinate analysis. in order to explore whether the expression of the core pfam protein domains are correlated with taxonomy, we did the following. first, we downloaded from the uniprot database (55) the amino acid sequence of each pfam along the different proteomes (see supporting information for details). their averaged (over proteomes) sequence lengths l resulted to be highly picked around specific values ranging from l = 46 to l = 297 (see supporting information, figure s3 , for the corresponding frequency histograms). second, for each family we computed the damerau−levenshtein (dl) distance between all its corresponding dna sequences. dl measures the edit distance between two strings in terms of the minimum number of allowed operations needed to modify one string to match the other. such operations include insertions, deletions/substitutions of single characters and transposition of two adjacent characters, which are common errors occurring during dna polymerase. this analogy makes the dl distance a suitable metric for the variation between protein sequences. by simplicity and to have a more immediate insight, we conducted the analysis only for sequence points corresponding to the five most abundant phyla, i.e. proteobacteria, firmicutes, actinobacteria, bacteroidetes and cyanobacteria. after computing the dl distance matrices between all the amino-acid sequences of each pfams along proteomes, we performed the multi dimensional scaling (mds) or principal coordinate analysis (pcoa) on the dl distance matrix. this step allow us to reduce the dimensionality of the space describing the distances between all pairs of core pfams of the different taxa and visualize it in a two dimensional space. in the last two columns of table 2 we inserted the percentage of the variance explained by the first two principal coordinates for the ten different core families, where the first one ranges from 3.3 to 12.1% and the second one from 2.4 to 7.7%. we then plotted the sequence points into the new principal coordinate space, colouring them by phyla. in general, we observed a two-case scenario. for some families as pf03883 (see figure 3 , left panel), actinobacteria and proteobacteria sequences are grouped in one or two highly visible clusters each, whereas the other three phyla do not form well distinguished structures, being their sequence points close one another, especially for cyanobacteria and firmicutes. for other families as pf01196 (see figure 3 , left panel), all five phyla result to be clustered, suggesting a higher correlation between taxonomy and amino-acid sequences (see supporting information, figure s4 , for the other core families graphics). these results suggest that some core families (e.g. ribosomal ones) are phyla dependent, while other are not directly correlated with taxa. we started by testing shotgun versus 16s taxonomic pipelines on three small artificial bacterial communities generated by jovel et al. (27) , whose raw data are publicly available (sequence read archive (sra) portal of ncbi, accession number srp059928). these mock populations contain dna from eleven species belonging to seven genera: salmonella enterica, streptococcus pyogenes, escherichia coli, lactobacillus helveticus, lactobacillus delbrueckii, lactobacillus plantarum, clostridium sordelli, bacteroides thetaiotaomicron, bacteroides vulgatus, bifidobacterium breve, and bifidobacterium animalis. for the taxonomic analysis at the genus level through 16s amplicon sequencing, we evaluated the performance of dada2 (38) and qiime2 pipelines (39) . in particular, as shown in (27), qiime2 produced more reliable results in terms of relative abundance of bacteria for all three mock communities when compared to mothur (56), another widely used 16s pipeline, and to the miseq reporter v2.5, a software developed by illumina to analyze miseq instrument output data. as for shotgun libraries, we tested the standard kaiju (28), kraken2 (26), the improved version of kraken (25) , and metaphlan2 (37), the improved version of metaphlan (47) . this latter relies on unique clade-specific marker genes and it had been shown to have higher precision and speed over other programs (27) . eventually, we tested core-kaiju on these mock communities and compared its performance with the above taxonomic classification methods. we inserted, for each core family (pfam id, first column), the percentage of proteomes in which it appears (prevalence, second column), the maximum number of times it occurrs in one proteome (maximal occurrence, third column), the total number of times it is found among proteomes in the pfam database (total occurrence, fourth column) and the percentage of variance explained by the firs two coordinates (pco1 and pco2, last two columns) when mds is performed on sequences belonging to the five most abundant phyla (see figure 3 ). after defining the core pfams, we created two protein databases for kaiju: the first database only contains the protein sequences from the core families, whereas the second database is the standard kaiju database based on the bacterial subset of the ncbi nr database. the protocol then follows these steps: 1. classify the reads with kaiju using the database with the core protein domains 2. classify the reads with kaiju using the nr database to get the preliminary relative abundances for each genus 3. discard from the list of genera detected in (2) those having absolute abundance of less than or equal to twenty reads in the list obtained in point (1). this threshold represents our confidence level on the sequencing pipeline (see below). 4. re-normalize the abundances of the genera obtained in point (3) . we evaluated the performance of both shotgun and 16s pipelines for the taxonomic classification of the three mock communities. in the top panels of figure 4 we show the true relative genus abundance composition of the three small mock communities versus the ones predicted via the different tested taxonomic pipelines. we then applied the core-kaiju pipeline to detect the biodiversity composition of the same three mock communities. in figure 4 , bottom panels, we plot the linear fit performed on predicted relative abundances via core-kaiju versus theoretical ones, known a priori. as we can see, in all three cases the predicted community composition was satisfactorily captured by our method, with an r 2 value higher than 0.7. our goal was to to quantitatively compare the performance of different methods in terms of both biodiversity and relative abundances. as for the first, we chose to measure it via the figure 4 . comparison between theoretical and predicted relative abundances in small mock communities. top panels: predicted relative abundance composition of the three small mock communities via different taxonomic classification methods. bottom panels: red points represent data of relative abundance predicted for the genus level by core-kaiju on the three mock communities versus the true ones, known a priori. the green line is the linear fit performed on obtained points which, in the best scenario, should coincide with the quadrant bisector (dotted red line). in all three cases the predicted community composition was satisfactorily captured by our method, with an r-squared value of 0.97, 0.96 and 0.71, respectively. f 1 score applied at the genera level. more precisely, we define the recall of a given taxonomic classification method as the number of truly-positive detected genera (present in a community and thus correctly detected by the method), t p , over the sum between t p and f n , the number of false-negative genera (present in a community, but missed to be classified). in contrast, we define the precision to be the ratio between t p and the sum of t n and f p , the number of false-positive genera (not present in a community and thus incorrectly detected as present). finally, the f 1 biodiversity score is twice the ratio between the product of recall and precision and their sum, i.e. f 1 = 2 * t 2 p /((t p +f n ) * (t p +f p )). f 1 score values obtained via the different methods for the three analysed mock communities are presented in table 3 . while f 1 describes the overall accuracy in detecting the correct number of genera in the sample, r 2 gives the correlation between the taxa abundance measured by the pipeline and the real composition of the microbial sample. finally, we also indicated the number of genera each method predicts,ĝ. table 3 summarizes the results of the analysis, together with the r-squared values, r 2 , obtained for the linear fit performed between true and predicted relative abundances. as we can see, both core-kaiju and metaphlan2 gave a good estimate of the number of genera in the communities (which is equal to seven), whereas all 16s methods slightly overestimated it. finally, both standard kaiju and kraken2 predicted a number of genera much higher than the true one. moreover, fit with standard kaiju and core-kaiju of the predicted abundances displayed a higher determination coefficient with respect to all other pipelines, with the exception of kraken2, which gave comparable values. however, if we focus on the f 1 score, we can notice that core-kaiju outperformed all the other methods in terms of precision and recall. in particular, since the pipeline led to zero false-positive and only one false negative genus (e.coli in all three communities), the resulting precision and recall were 1 and 0.86 for all the sampled mocks. with core-kaiju, we were therefore able to produce a reliable estimate of both the number of genera within the communities and their relative abundances. as stated in the introduction and observed above, metagenomic classification methods, such as kaiju, often give a high number of false-positive predictions. in principle, one could set an arbitrary threshold on the detected relative abundances, for example 0.1% or 1%, to filter out lowabundance taxa that are likely false-positives. however, different choices of the threshold typically lead to very different results. the top panels of figure 5 shows the empirical taxa abundance distribution of the 674 genera table 3 . f 1 score, r-squared values and number of predicted genera. for all three analysed mock communities, we inserted the f 1 score (twice the ratio between the product of recall and precision and their sum), the r 2 value of the linear fit performed between estimated and true abundances together with the number of predicted genera,ĝ, with various taxonomic methods. the true number of genera is g = 7 for each community. mock 2 (g = 7) mock 3 (g = 7) 34, 9 or 7 if one considers only genera accounting for more than 0.01%, 0.1% and 1% of the total number of sample reads, respectively. moreover, looking at the empirical pattern, one can notice the main gap between genera covering a fraction of less than 5·10 −3 with respect to the total number of reads (black points) and those covering a fraction higher than 2·10 −2 (green points), which corresponds to the genera actually present in the artificial community. one could therefore hope that, whenever such a gap is detected in the taxa abundance distribution, this corresponds to the one between false-positive and truly present taxa. however, as will be clear in the following section, this is not the case and it is not possible to set a relative threshold for the shotgun methods that works for all the mock communities. we tested and compared standard kaiju, kraken 2 and core-kaiju also on medium and high complexity mock bacterial communities obtained from the 1st cami challenge (45) , in terms of biodiversity (recall, precision, f 1 score,ĝ) and abundance composition (linear fit r-squared). in table 4 we show the results for samples 1 and 5 of the high-complexity dataset (see supporting information for the results of the other samples). as we can see, core-kaiju strongly outperformed the other methods in terms of precision. indeed, it only slightly overestimated the true number of genera of around 10 taxa in sample 1, and 20 taxa in sample 5 (see table 4 ), which is two order of magnitude lower with respect to the other methods (that predicted > 1600 of taxa). on the other hand, as also shown from the bottom panels of figure 5 , when using in standard kaiju (or kracken 2) a relative threshold of 1% so to reduce the number of false-positive taxa, as suggested by the previous analysis on the small mock community, the number of predicted taxa is in this case around 30, therefore strongly underestimating the real biodiversity of the samples. as for the recall, the performance of core-kaiju (values around 77%) stands between standard kaiju (values around 96%) and kraken2 (values around 65%). the combination of recall and precision led to an f 1 score around 74%, much higher than the other two pipelines (13%). finally, as shown in figure 6 , core-kaiju gave also a very good estimation of the microbial composition, with an r-squared for the fit between theoretical and predicted relative abundances above 0.88, value comparable to standard kaiju and much higher than the one obtained with kraken2 (0.45). in the supporting information we present all the results for the other highcomplexity samples as well as the analyses performed on the medium-complexity challenge dataset and the sensitivity of the classification on the absolute thresholds. we finally applied core-kaiju taxonomic classification method to an empirical data-set. we analysed a cohort of 26 healthy human fecal samples from the study (57) (metagenomic sequencing data are publicly available at the ncbi sra under accession number srp057027). we applied standard kaiju and found on average (over the 26 samples) 2108 bacterial genera. similar overestimation of the number of taxa of kajiu 1.0 would be obtained also with kracken 2, highlighting the above mentioned problem of setting the correct threshold in order to have a realistic estimation of the sample biodiversity. the right panel of figure 7 shows the empirical taxa abundance distribution of one individual (sample id: srr2145359). as we can see, in this case the only apparent gap occurs between relative abundance of less than 10 −1 and those above 0.5, with only one genus. it therefore results quite unrealistic that all the taxa but one should be considered falsepositive. the same plot shows the vertical lines corresponding to threshold on relative population of 0.01%, 0.1% and 1% above which we have 97, 32 and 10 taxa, respectively. in contrast, with core-kaiju we did not need to tune a relative threshold. instead, by removing false-positive through the (fixed) absolute abundance of 20 reads we ended up with 21 genera (orange diamonds in figure 7) , which is compatible with previous estimates. in fact, the available ampliconsequencing datasets from stool samples of healthy participants of the human microbiome project (1) suggest that there are on average 25 different bacterial genera per sample (based on 174 samples with at least >5k reads per sample using 97% otu the red triangle corresponds to the unique false-negative genus (e.coli) undetected with the newly proposed method. dashed lines represent relative abundance thresholds on standard kaiju output of 0.01%, 0.1% and 1%, respectively, which would have led to a biodiversity estimate of 34, 9 and 7 genera, respectively. imposing an absolute abundance threshold of twenty reads on standard kaiju output directly, would instead lead to an overestimation of 99 genera. bottom panels: the same analyses have been performed on the cami high-complex sample 1. again, green diamonds represent the 146 out of 193 genera present in the community and correctly detected by our pipeline. in this case, in addition to the remaining 47 false-negative genera (red triangles) we have also the presence of 58 false-negative genera, here represented by gray triangles. setting a threshold on the relative abundance of reads produced by standard kaiju gives a number of genera of 237 for the 0.01%, 120 for the 0.1% and 30 for the 1% threshold, respectively. left and right panels represent, respectively, log-log absolute frequency and cumulative patterns of the taxa abundances in the mock communities. clustering). however, in terms of taxa composition, core-kaiju predicted abundances are different from those obtained using 16s classification methods (1). an important source of errors in the performance of any algorithm working on shotgun data is the high level of plasticity of bacterial genomes, due to widespread horizontal transfer (41, 58, 59, 60, 61, 62) . indeed, most highly abundant gene families are shared and exchanged across genera, making them both a confounding factor and a computational burden for algorithms attempting to extract species presence and abundance information. thus, while having access to the sequences from the whole metagenome is very useful for functional characterization, restriction to a smaller set of families may be a very good idea when the goal is to identify the species taxa and their abundance. to summarize, we have presented a novel method for the taxonomic classification of microbial communities which exploits the peculiar advantages of both whole-genome and 16s rrna pipelines. indeed, while the first approaches are recognised to better estimate the relative taxa composition of samples, the second are much more reliable in predicting the true biodiversity of a community, since the comparison between taxa-specific hyper-variable regions of bacterial 16s ribosomal gene and comprehensive reference databases allows in general to avoid the phenomenon of false-positive taxa detection. indeed, the identification of a threshold in shotgun table 4 . performance comparison on cami high-complexity samples 1 and 5. in the first four columns, we inserted the values for the precision, the recall, the f 1 score, the r 2 value of the linear fit performed between estimated and true abundances, and the number of predicted generaĝ with core-kaiju, standard kaiju and kraken2. the true number of genera is g = 193 for each sample. in the last column we also inserted the number of genera one would predict with standard kaiju and kraken2 by setting a relative threshold of 1%, i.e. by considering false-positive all those genera having a relative abundance of less than 0.01 in the sample. we denoted this quantity byĝ 1% . sample 5 (g = 193) figure 6 . linear fit between theoretical and predicted relative abundances with core-kaiju. red points represent data of relative abundance predicted for the genus level by core-kaiju on sample 1 and 5 from the cami highly-complex dataset versus the ground-truth abundances, known a priori. the green line is the linear fit performed on such values which, in the case of perfect matching between data and cor-kaiju output, should coincide with the quadrant bisector (dotted red line). in both cases, the predicted community composition was satisfactorily captured by our method, with a correlation with the real taxa abundances of r 2 = 0.9 and r 2 = 0.88 for sample 1 and 5, respectively. methods to remove most of the false-positive is of course a critical problem, because in general the true taxa composition is not known, and thus setting the wrong threshold may lead to a huge over-(or under-) estimation of the sample biodiversity, as shown in this work. inspired by the role of 16s gene as a taxonomic fingerprint and by the knowledge that proteins are more conserved than dna sequences, we proposed an updated version of kaiju, an open-source program for the taxonomic classification of whole-genome high-throughput sequencing reads where sample metagenomic dna sequences are firstly converted into amino-acid sequences and then compared to microbial protein reference databases. we identified a class of ten domains, here denoted by core pfams, which, analogously to 16s rrna gene, on one hand are present in the overwhelming majority of proteomes, therefore covering the whole domain of known bacteria, and which on the other hand occur just few times in each of them, thus allowing for the creation of a novel reference database where a fast research can be performed between sample reads and pfams amino-acid sequences. tested against mock microbial communities, of different level of complexity, generated in other studies (27, 45) and available online, the proposed updated version of kaiju, core-kaiju, outperformed popular 16s rrna and shotgun methods for taxonomic classification in the estimation of both the total biodiversity and taxa relative abundance distribution. in fact, by fixing an absolute threshold with core-kaiju (by only considering abundances greater to twenty reads), we are able to correctly classify the biodiversity in all samples of different size and complexity, while keeping a very good performance in the prediction of taxa abundances. we highlight that other technologies exist beyond metagenomics or 16s amplicons on a miseq (integrated instrument performing clonal amplification and sequencing), as for example pacbio (63). earl and collaborators (64) used a cami dataset to test the accuracy of this method and it is therefore possible to indirectly compare core-kaiju with pacbio through their results. also in this case we found that our method gives a slightly higher r 2 score for the genera abundances composition, confirming the competitiveness of core-kaiju even with long-read technology such as pacbio. however, a deeper comparison with these methods goes beyond the scope this work because, although might perform better than miseq next-generation sequencing approaches, they are quite rare and available only for much higher price. our promising results pave the way for the application of the newly proposed pipeline in the field of microbiotahost interactions, a rich and open research field which has recently attracted the attention of the scientific world due to the hypothesised connection between human microbiome nevertheless estimates from a reference cohort of stool microbiomes (46) from 174 healthy hmp participants (16s v3-v5 region, >5k reads per sample, 97% otu clustering), report an average number of genera per sample of 25 (max=46, min=9) (1). setting a threshold on the relative abundance of reads produced by standard kaiju gives a number of genera of 97 for the 0.01%, 32 for the 0.1% and 10 for the 1% threshold, respectively. in contrast, considering false-positive all genera with less or equal to twenty reads in standard kaiju output, we end up with 625 genera. orange diamonds in plot correspond to the 21 genera detected with core-kaiju, a number compatible with the reported estimates. left and right panels represent log-log absolute frequency and cumulative patterns, respectively. and healthy/disease (65, 66) . having a trustable tool for the detection of microbial biodiversity, as measured by the number of genera and their abundances, could have a fundamental impact in our knowledge of human microbial communities and could therefore lay the foundations for the identification of the main ecological properties modulating the healthy or ill status of an individual, which, in turn, could be of great help in preventing and treating diseases on the basis of the observed patterns. all data and codes used for this study are available online or upon request to the authors. raw data for the three in-silico mock communities (27) are publicly available at the sequence read archive (sra) portal of ncbi under accession number srp059928. metagenomic sequencing data of the healthy human fecal samples from the study (57) are publicly available at the ncbi sra under accession number srp057027. cami medium and high complexity datasets are available at https://data.cami-challenge.org/participate under request. this work was supported by the stars grant 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dada2: high-resolution sample inference from illumina amplicon data reproducible, interactive, scalable and extensible microbiome data science using qiime 2 joint scaling laws in functional and evolutionary categories in prokaryotic genomes cross-species gene-family fluctuations reveal the dynamics of horizontal transfers familyspecific scaling laws in bacterial genomes statistics of shared components in complex component systems the pfam protein families database in 2019 critical assessment of metagenome interpretationa benchmark of metagenomics software metagenomic microbial community profiling using unique cladespecific marker genes deblur rapidly resolves single-nucleotide community sequence patterns analysis of the intestinal microbiota using solid 16s rrna gene sequencing and solid shotgun sequencing estimating the size of the bacterial pan-genome zipf and heaps laws from dependency structures in component systems universal distribution of component frequencies in biological and technological systems a neutral theory of genome evolution and the frequency distribution of genes gene frequency distributions reject a neutral model of genome evolution uniprot: a hub for protein information introducing mothur: open-source, platform-independent, community-supported software for describing and comparing microbial communities inflammation, antibiotics, and diet as environmental stressors of the gut microbiome in pediatric crohns disease the phylogenetic forest and the quest for the elusive tree of life. cold spring harbor symposia on quantitative biology search for a 'tree of life' in the thicket of the phylogenetic forest the tree and net components of prokaryote evolution genome-wide comparative analysis of phylogenetic trees: the prokaryotic forest of life genomic fluidity: an integrative view of gene diversity within microbial populations pacbio sequencing and its applications genomics species-level bacterial community profiling of the healthy sinonasal microbiome using pacific biosciences sequencing of full-length 16s rrna genes microbiome the gut microbiome in health and in disease rakoff-nahoum s. the evolution of the host microbiome as an ecosystem on a leash none declared. key: cord-276428-oy8e2cpx authors: krishnan, lakshmi; ogunwole, s. michelle; cooper, lisa a. title: historical insights on coronavirus disease 2019 (covid-19), the 1918 influenza pandemic, and racial disparities: illuminating a path forward date: 2020-06-05 journal: ann intern med doi: 10.7326/m20-2223 sha: doc_id: 276428 cord_uid: oy8e2cpx the coronavirus disease 2019 (covid-19) pandemic is exacting a disproportionate toll on ethnic minority communities and magnifying existing disparities in health care access and treatment. to understand this crisis, physicians and public health researchers have searched history for insights, especially from a great outbreak approximately a century ago: the 1918 influenza pandemic. however, of the accounts examining the 1918 influenza pandemic and covid-19, only a notable few discuss race. yet, a rich, broader scholarship on race and epidemic disease as a “sampling device for social analysis” exists. this commentary examines the historical arc of the 1918 influenza pandemic, focusing on black americans and showing the complex and sometimes surprising ways it operated, triggering particular responses both within a minority community and in wider racial, sociopolitical, and public health structures. this analysis reveals that critical structural inequities and health care gaps have historically contributed to and continue to compound disparate health outcomes among communities of color. shifting from this context to the present, this article frames a discussion of racial health disparities through a resilience approach rather than a deficit approach and offers a blueprint for approaching the covid-19 crisis and its afterlives through the lens of health equity. the coronavirus disease 2019 (covid-19) pandemic is exacting a disproportionate toll on ethnic minority communities and magnifying existing disparities in health care access and treatment. to understand this crisis, physicians and public health researchers have searched history for insights, especially from a great outbreak approximately a century ago: the 1918 influenza pandemic. however, of the accounts examining the 1918 influenza pandemic and covid-19, only a notable few discuss race. yet, a rich, broader scholarship on race and epidemic disease as a "sampling device for social analysis" exists. this commentary examines the historical arc of the 1918 influenza pandemic, focusing on black americans and showing the complex and sometimes surprising ways it operated, triggering particular re-sponses both within a minority community and in wider racial, sociopolitical, and public health structures. this analysis reveals that critical structural inequities and health care gaps have historically contributed to and continue to compound disparate health outcomes among communities of color. shifting from this context to the present, this article frames a discussion of racial health disparities through a resilience approach rather than a deficit approach and offers a blueprint for approaching the covid-19 crisis and its afterlives through the lens of health equity. ann intern med. doi:10.7326/m20-2223 annals.org for author, article, and disclosure information, see end of text. this article was published at annals.org on 5 june 2020. * drs. krishnan and ogunwole contributed equally to this work. t he coronavirus disease 2019 (covid-19) pandemic has killed more than 100 000 persons in the united states (1) . nationwide data indicate that ethnic minority communities, particularly black, latinx, and native or indigenous communities, suffer disproportionately (2) (3) (4) (5) (6) (7) . this has significant historical antecedents; as evelynn hammonds recently argued, epidemic diseases "lay bare and make visible inequalities in a society" (8) . yet, at the onset of the crisis, few reported its effect on minorities (9) . even now, we may not know the full scope and details. many states have published limited statistics, and race-stratified data, once fully released, will need to be carefully interpreted to address the causes of inequity rather than to perpetuate stigma and discrimination (10) . unfortunately, this comes as no surprise to health equity researchers and historians of medicine and public health. the united states has a long history of racial and socioeconomic disparities, with the current pandemic further revealing the rifts created by historical injustice, structural racism, and interpersonal bias (11-13). although some have touted covid-19 as a "great equalizer" that strikes across age, sex, race/ethnicity, and geography, we contend that it has magnified the many "unequalizers" in our society (14, 15) . to understand the current crisis, physicians and public health researchers have mined history for insights (16) . most have focused on a century-old outbreak, the 1918 influenza pandemic (misleadingly called the "spanish flu"), because covid-19 most closely approximates it in scope and effect (17) (18) (19) . of the accounts comparing the 1918 influenza pandemic and covid-19, only a notable few discuss race (8, 20, 21 ). yet, a rich, broader scholarship on race and epidemic disease as a "sampling device for social analysis" exists (22) (23) (24) (25) (26) (27) . given the excessive mortality due to covid-19 in minority communities, reexamination of such historical antecedents is fruitful. although this scholarship hesitates to offer predictions, this kind of analysis can provide orienting frameworks, reveal nuance, and modulate our approach to the current crisiswhich has been called "unprecedented," reflecting a lack of historical context. we examine the historical arc of the 1918 influenza pandemic, focusing on black americans and showing the complex, sometimes surprising ways it triggered particular responses both within a minority community and in wider racial, sociopolitical, and public health structures. shifting to the present, we frame a discussion of racial health disparities through a resilience approach versus a deficit approach and offer a blueprint (table) for approaching the covid-19 crisis and its afterlives through the lens of health equity. elected leaders should exercise an abundance of precaution when facing potential public health threats. providing accurate information, overpreparing, and not underreacting are key. leaders (whether community based or elected) are role models. communities of color may look to these persons to guide their own behaviors. persons in positions of power or influence should be held to high standards and model the importance of strict adherence to strategies aimed at controlling and reducing infectious disease spread. transparency and communication are key to timely adoption of mitigation strategies by the general public; when these are absent, erosion of trust ensues. early transparency and communication are key to timely adoption of mitigation strategies by the general public. however, even with these strategies, historical precedence may make it difficult for communities of color to trust information from the government. in this scenario, it is especially important to engage trusted messengers, such as community leaders and faith-based organizations, to help deliver critical information. for communities of color, each conversation and transfer of information is an opportunity to either rebuild trust or further substantiate mistrust. elected leaders should thus be held accountable for misinformation, and the public should be aware of credible sources of information. counting and reporting are critical for measuring disparities in health and planning equitable interventions. technology should be leveraged to support data collection for public health surveillance and social service needs. data collected on disease incidence should be stratified by key demographic factors. blaming specific groups for infectious disease spread is counterproductive and can be dangerous for the groups indicted. disinformation based on racism and stigma is unacceptable; leaders in all sectors should rely on scientific facts to guide conversations on infectious disease spread. they should maintain neutral positions and should not place blame on specific groups. social determinants of health are key drivers of health disparities and also affect the ability to participate in infectious disease mitigation strategies. policy initiatives must address social determinants of health before pandemics arise. support for social services must be better integrated into the health care system. health systems should anticipate increased need for social support during pandemics and have strategies in place to deliver services to the most vulnerable populations. this includes enhanced access to technology to support telecommunication for vulnerable populations. chronic medical conditions are significant contributors to morbidity and mortality during the pandemic. health care policy changes are needed to enable access to primary care and preventative services throughout the life course. there will be long-term sequelae related to covid-19 (both directly because of virus-related morbidity and indirectly as a result of reduced access to care during social distancing periods). the health care system should plan for and anticipate a surge in the need for primary and specialty care services. institutional and structural forces keep communities of color from achieving their full potential. a restorative justice approach that includes the following strategies, among others, should be used: • investments in early education • financial assistance for higher education or trade schools; forgiveness for previously accumulated education debt • investment in public housing; fair and equitable access to home loans • fair and equitable access to business loans; incentives for minority-owned businesses • investment in neighborhood environments: resources for community-led neighborhood violence prevention strategies, increases in green space, walking trails, reduction in food deserts • universal access to health care, including mental health care • integration of faith-based organizations into the health care system • restructuring of the criminal justice system; employment opportunities after incarceration communities of color lead, persevere, and innovate. they play an essential role in building bridges toward trust in the health care system and improving health outcomes within their communities. their contributions help to advance science and medicine and deserve recognition. communities of color should be given opportunities to actively participate in agenda setting, research, and policy initiatives aimed at improving their communities so they can be recognized and acknowledged for their contributions. building and restoring trust is an ongoing process that is necessary to advance medicine, science, and health care. this can be aided through some of the following measures: • support for strategies aimed at improving and maintaining a diverse health care workforce • community-based participatory research throughout all phases of the research process (design, implementation, dissemination, and evaluation) • utilization of trusted community partners and community health workers to aid in community education; improvement in recruitment and participation in research, including clinical trials; gathering of quantitative and qualitative data in the field throughout all phases of pandemic response covid-19 = coronavirus disease 2019. * all phases should be responsive to the possibility of future waves of disease. historical insights on covid19, 1918 influenza, and racial disparities on black americans, who, for example, accounted for an overwhelming number of the 50 000 deaths in the 1862-1867 smallpox epidemic (26) . contagion also augmented biologically deterministic beliefs, including that blacks were innately immune to certain diseases. during the 1792-1793 yellow fever epidemic in philadelphia, white physicians, such as benjamin rush, asked black community leaders absalom jones and william gray to "furnish nurses to attend the afflicted" because of the erroneous assumption that blacks could not contract the disease (32, 33) . however, in the context of these preceding epidemics, the 1918 influenza pandemic forms a unique case study. although all-cause morbidity and mortality in the early 20th century was higher for black americans than white americans, the few studies examining racial differences in the 1918 pandemic found that the black population had lower influenza incidence and morbidity but higher case fatality (23, 34) . black physicians shared this view, as evidenced in the journal of the national medical association and local newspaper articles (35, 36). meanwhile, white public health figures, like chicago commissioner of public health john dill robertson, used these findings to justify biological determinism, concluding that "the colored race was more immune than the white to influenza" (37) . rebuttals to these innate immunity theories circulated in the black print media. respected and widely read periodicals, such as baltimore's afro-american, the chicago defender, and the philadelphia tribune, carefully documented influenza's effect, with personal columns, church registers, and town updates listing the many community members who had the "flu," shaming those not taking it seriously, or mourning others, such as a promising young teacher and morgan college graduate (38 -42). other articles warned black americans to take adequate precautions and discounted theoretical immunity: "while the death rate from the epidemic of influenza is not as high as the white death rate, colored people are far from being immune of the disease" (43) . in december 1918, african american columnist william pickens debunked the claim of a white west virginian who claimed the "influenza germ had shown that god was partial in favor of black people." pickens countered that for whites, "when negroes die faster, it is often escribed [sic] to their inferiority," but if spared, "well, that proves they are not human like the rest of us" (44) . these critiques highlight differences between pandemic coverage and explanatory models in the "mainstream" versus black press-the latter was community-centered, focused on trusted sources and internal solutions, and skeptical about the veracity and benevolence of white responses. how do we account for black americans' lower influenza infection rates and all-cause mortality but higher case-fatality rate during the 1918 influenza pandemic? alfred crosby hypothesizes that higher exposure to the less virulent early wave may have made black americans less susceptible to the fall/winter wave (45, 46) . this assumes many interlinked circumstances, including higher likelihood of blacks living in over-crowded environments and therefore greater exposure during the spring/summer wave; poorer access to sanitation, potable water, and hygiene than white counterparts; and early exposure conferring immunity against the deadlier autumn wave. segregation may also have functioned as an unintentional cordon sanitaire, quarantining blacks from whites. finally, recall that supporting data are limited by likely underreporting (23) . nonetheless, it is worth noting the higher case-fatality rate, which could be attributed to several factors still present today: higher risk for pulmonary disease, malnutrition, poor housing conditions, social and economic disparities, and inadequate access to care. in sum, if a black person caught influenza in 1918, they were more likely to die-an outcome which, despite lower infection and all-cause mortality rates, has significant repercussions. aggregate influenza data before and after the 1918 -1919 season reflect a more familiar pattern: significantly higher morbidity and mortality among nonwhites compared with whites (47) . that the outcomes of black americans did not improve in the interim suggests that the influenza pandemic did little to mobilize national responses for improving their health status, a precedent that we hope is not replicated in the current crisis. the broader context of the 1918 pandemic is critical for understanding the historical, as well as contemporaneous, landscape of health disparities. a confluence of factors, including social policies of racial exclusion and discrimination, unequal provision of health care, housing inequality, malnutrition, chronic respiratory disease, and increased epidemiologic burden of infectious diseases (such as tuberculosis, typhoid fever, whooping cough, and infant diarrheal illnesses), contributed to lower life expectancy for black americans (25) . new academic disciplines, such as anthropology, evolutionary biology, genetics, and eugenics, helped promote theories of biological determinism, which compounded older views attributing poor health outcomes to the inferior qualities of black americans (48) . the jim crow laws boosted white supremacy with these ideologies to enforce racial segregation, and between 1916 and 1919, in the thick of the influenza pandemic, approximately half a million blacks fled the punitive south for midwestern and northern cities in the now-famous great migration. however, those cities often greeted them with prejudice, stigma, segregationist policies, and violence, allegedly aimed at improving public health. a march 1917 chicago daily tribune headline proclaimed, "rush of negroes to city starts health inquiry"; during the pandemic, the headline "half a million darkies from dixie swarm to the north to better themselves" appeared. reporter henry m. hyde named southern black migrants as disease vectors: "compelled to live crowded in dark and insanitary rooms; they are surrounded by constant temptations" (20, 49) . these views provided justification for draconian public health ordinances and restrictive housing covenants that maintained housing color lines and prevented black chicagoans from leaving overcrowded conditions ("the black (50) . residential segregation also played a role in the outbreak in baltimore, the first large american city to pass drastic housing legislation in 1910. consequently, many black baltimoreans lived in "alley districts" or high-occupancy "tenant houses" with poor sanitation and ventilation and higher rates of epidemic disease (25, 51) . influenza overwhelmed medical resources straining under the burden of urban density, unequal living conditions, and a high concentration of military training camps (52, 53) . downplaying by authorities like health commissioner dr. john d. blake, who called it the "same old influenza" physicians have long treated, exacerbated the problem (54). blake eventually reversed course, imposing citywide restrictions and "social distancing," but not in time to stanch the tide. segregation and structural racism extended to medical education and health care delivery, but community mobilization, well under way before the pandemic, was a counterbalance. by the early 20th century, black activists and professionals led many health institutions and flagship organizations: howard university college of medicine (founded in 1868), tuskegee institute hospital and nurse training school (founded in 1892), meharry medical college (founded in 1876), the national medical association (founded in 1895), and the national association of colored graduate nurses (founded in 1908). at the same time, the flexner report (published in 1910) disadvantaged minority health education-only 2 of the initial 7 black medical schools survived its reforms, and they struggled financially during the influenza pandemic (55) . black nurses, excluded from world war i service by the u.s. army medical corps and the red cross and battling for inclusion in the u.s. armed forces nurses corps, nevertheless served on influenza frontlines. in october 1918, afro-american declared that these essential workers were "at a premium," noting that the self-same "red cross leaders are appreciative of the response colored women have made . . ." (56) . yet, black patients were often disbarred from care, leading to local and decentralized efforts to provide care within the community. black professionals took great pride in their role fighting influenza. as dr. john p. turner wrote (57): the negro physician played a most prominent part in treating and relieving victims of every race . . . [yet] will possibly never be cited in the history to be written of the 1918 epidemic. however we want to call to the attention of the medical profession of america the unselfish devotion to duty that impelled three thousand legal practitioners of medicine of african de-scent to work night and day to aid in checking the monster scourge. although most black health professionals did not receive due praise or recognition, disruptions in the wake of world war i and the 1918 pandemic did shift the u.s. medical landscape. it was partly because of the "scarcity of white medical men" as well as ardent community efforts and activism that places like the harlem hospital desegregated (1919 -1935) ; louis t. wright, later a prominent surgeon and civil rights activist, became the first black physician to join its staff in 1919 (58) . historians remark that, unlike other cataclysmic events, the 1918 pandemic left minimal traces in public memory and culture; its neglect has led to its being called the "forgotten pandemic" (46). however, this assertion overlooks its multivariate effect on the african american community. although the influenza pandemic does not reveal ready associations between deleterious social, cultural, and economic conditions and poor outcomes (aside from higher case-fatality rate) for black americans, the gaps in historical documentation may reflect inherent disparities and consequences of limited racial/ethnic data collection. this absent archive may indeed have been a setback for public health and health equity-a missed opportunity to intervene on the basis of the specific contexts and unique vulnerabilities of different groups. in this way, the 1918 influenza pandemic is an illuminating case study for understanding the role of pandemics in the history of health disparities and the broader health equity movement. for black americans, surviving and fighting the 1918 pandemic was a catalyzing step up the social ladder, a cause for communal effort and activism, and a justification for profound engagement with health, which was seen as bound to the greater social condition. it concretized the spirit of community resilience and helped contribute to desegregation and the nascent civil rights movement. however, because of minimal national mobilization to improve the health of communities of color, it also compounded mounting distrust in the u.s. government to intervene and help improve the health and lives of its nonwhite citizens, a wariness that we see replayed in the covid-19 pandemic. reflecting on the 1918 influenza pandemic in the setting of covid-19, we note important parallels while recognizing many differences in context. despite the past century's therapeutic evolution, we find ourselves in a situation similar to 1918, without a vaccine or proven treatments for a deadly disease. furthermore, structural inequities have historically contributed and continue to compound disparate health outcomes in communities of color. evaluating historical trends is critical for health equity work, and through attending to the complexities of the 1918 pandemic, we have the opportunity to ground our current and future strategies in this historical context, deliver a more equitable panhistorical insights on covid-19, 1918 influenza, and racial disparities demic strategy, and reduce disparities in marginalized communities. as physicians who also serve other roles (health equity researchers, historians of medicine, educators, and advocates), we propose several areas for intervention and mobilization throughout the various phases of pandemic response. delaying swift public health measures significantly affected the pandemic curve trajectory in the 1918 influenza pandemic. cities that enacted swift and sustained nonpharmaceutical interventions had lower excess mortality rates than their counterparts (58 -60) . similarly, initial failure to acknowledge severe acute respiratory syndrome coronavirus 2 as a credible threat hampered containment and mitigation efforts (61). several months later, as much of the nation strategizes reopening, we must maintain vigilant mitigation strategies while aligning recommendations with emerging epidemiologic data. failure to do so could result in new waves of disease, as was the case in 1918. within the african american community, specific communication barriers, augmented by a lack of covid-19 -related demographic data, contributed to underestimating the pandemic's effect. misinformation and recycled, erroneous narratives about black immunity circulated through social media (62) . historical distrust of biomedicine amplified these effects (63) . however, as available data emerged outlining covid-19's devastating disparities, black organizations, leaders, and media outlets aggressively campaigned to dispel myths, implored citizens to heed sanitation and containment advice, and advocated for community resources. this kind of community-led strategy has repeatedly been critical in counteracting national failures to protect minorities. furthermore, such interventions bridge divides forged by historical mistrust-they are central to dissemination of information and community activation (64) . however, misinformation, oversight, and delayed mitigation strategies alone do not fully explain differential covid-19 incidence. many have deeply analyzed the effect of social determinants on covid-19 disparities (15, 65, 66) . this historical inheritance, of which the 1918 influenza pandemic forms just 1 episode, shapes how social conditions obstruct minority participation in public health mitigation and containment measures. it also extends to risk factors for chronic disease development, making african americans more susceptible to covid-19 -related morbidity and mortality (67) . as a result of redlining, for instance, minority residential environments bear substantial barriers to health optimization, such as reduced green space access, disproportionate tobacco and alcohol marketing, low perceived neighborhood safety, and food deserts (68) . health equity researchers have proposed reforms, including interventions by local governments to provide food, housing, education, employment, and technological support, but this approach is necessarily reactive rather than reparative and preventive (69, 70) . an advantage of the current era compared with 1918 is our ability to collect robust data that can inform a more proactive strategy. structural, environmental, and economic data on essential goods and services can enhance epidemiologic data. when stratified at the level of key social determinants of health, this information can be used to identify which communities are most vulnerable and ensure prudent and equitable dissemination of resources. in addition to the relief response, we must examine the nature of blame and stigma during pandemics, paying particular attention to dangerous narratives of personal responsibility as a key driver of health outcomes (71) . these accounts place the burden of differential outcomes on minorities rather than acknowledging the lasting legacy of structural racism. they also detach minority health from that of the majority rather than viewing it as part of the nation's collective mission. the trajectory of the covid-19 pandemic remains uncertain; it may abate, or we may face resurgent waves during reopening, as seen during the 1918 influenza pandemic. if the latter, we must acknowledge the history of public health response, correcting prior mistakes and attempting to duplicate applicable practices. if the former, we must still consider our path toward equity in recovery. challenges for communities of color will include long-term covid-19 sequelae, exacerbation of underlying chronic conditions, and mistrust in the health care system, perhaps reinforced by the current crisis. creating antidotes to this mistrust will be critical; components should include collaboration with trusted community and media partners, a diverse health care workforce to offer racially concordant care teams, and community-based participatory research. this will in turn support the actions needed to reduce disparities, including recruiting a representative population into future covid-19 -related clinical trials and epidemiologic studies, ensuring adequate uptake during vaccination campaigns, enhancing engagement with primary care for improved chronic disease prevention and management, and seeking the narrative and lived experience of minorities to guide future public health communication and strategy (16, 72) . however, there is reason to be hopeful. perhaps the most important conclusion drawn from an analysis of the 1918 influenza pandemic is that minority communities are resilient, are resourceful, and find restoration in community. the most successful strategies to advance health equity would be to 1) examine the historical arc contextualizing current disparities in vulnerable communities; 2) recognize the inherent strengths in these communities, empowering them to participate in research and generate solutions alongside those who traditionally hold power; 3) acknowledge the contributions of frontline workers in communities of color; 4) prepare for future public health emergencies by enhancing minority civic participation; and 5) use a restorative justice framework to acknowledge and make amends for the structures contributing to disadvantages in these communities (73, 74) . taken together, these strategies provide the opportunity to use this challenging moment to transform clinical and public health practice by grounding it in social justice. although the covid-19 pandemic will eventually abate, its aftershocks will be perceptible for generations. there is no doubt that it will change public health practice and clinical delivery, which are intimately intertwined. yet, it will also shift the political and social landscapes. as arundhati roy recently wrote in "the pandemic is a portal": "we can choose to walk through it, dragging the carcasses of our prejudice and hatred, our avarice, our data banks and dead ideas . . . or we can walk through lightly, with little luggage, ready to imagine another world. and ready to fight for it" (75) . when the dust settles in the wake of covid-19, let us not allow ourselves to fall into a great amnesia, another forgotten pandemic. let us remember whom this disproportionately affected and why. taking this as impetus for mobilization, let us begin to rewrite the story of health disparities in america. in this new chapter, we will be better prepared to offer all citizens a fair and just opportunity to attain their highest level of health. current author addresses and author contributions are available at annals.org. covid-19 dashboard covid-19 fatalities covid-19 infection rates based on education and race. abc news chicago's coronavirus disparity: black chicagoans are dying at nearly six times the rate of white residents, data show 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harlem hospital: a centennial. the new york academy of medicine nonpharmaceutical interventions implemented by us cities during the 1918-1919 influenza pandemic public health interventions and epidemic intensity during the 1918 influenza pandemic baltimore city plans coronavirus ad campaign to combat myth that african american residents are immune. baltimore sun coronavirus fight shifts to baltimore's poor neighborhoods as city leaders battle mistrust. baltimore sun public communications and its role in reducing and eliminating health disparities. in: institute of medicine (us) committee on the review and assessment of the nih's strategic research plan and budget to reduce and ultimately eliminate health disparities examining the health disparities research plan of the national institutes of health: unfinished business failing another national stress test on health disparities covid-19 and health equity-a new kind of "herd immunity hospitalization and mortality among black patients and white patients with covid-19 social sources of racial disparities in health a game plan to help the most vulnerable data and policy solutions to address racial and ethnic disparities in the covid-19 pandemic what the surgeon general gets wrong about african americans and covid-19. cnn. 15 reducing racial inequities in health: using what we already know to take action restorative justice & other public health approaches for healing: transforming conflict into resiliency. lorenn walker blog accessed at www.ft.com/content/10d8f5e8-74eb-11ea-95fe-fcd274 e920ca on 17 history of medicine historical insights on covid-19, 1918 influenza, and racial disparities current author addresses: dr. krishnan: johns hopkins university school of medicine suite #2-300a critical revision of the article for important intellectual content historical insights on covid-19, 1918 influenza, and racial disparities key: cord-022075-bbae2nam authors: gougelet, robert m. title: disaster mitigation date: 2009-05-15 journal: disaster medicine doi: 10.1016/b978-0-323-03253-7.50028-5 sha: doc_id: 22075 cord_uid: bbae2nam nan c h a p t e r 2 1 the definition of mitigation includes a wide variety of measures taken before an event occurs that will prevent illness, injury, and death and limit the loss of property. mitigation planning commonly includes the following areas: • the ability to maintain function • building design • locating buildings outside of hazard zones (e.g., flood plains) • essential building utilities • protection of building contents • insurance • public education • surveillance • warning • evacuation it is of critical importance that emergency planners incorporate the basic elements of mitigation and have the authority and resources to incorporate these changes into their organization/facility/community. emergency planners should have a basic idea of the concepts of mitigation through their use in natural disasters over the years. the recent federally mandated transition to the all-hazards approach in disaster emergency response has also given a new perspective on mitigation. although it is not necessary to redefine mitigation, it is essential to understand how the scope and complexity of mitigation and risk reduction strategies have evolved as the united states adapts to new threats. for example, what measures can be taken in advance to protect the population and infrastructure from an earthquake, flood, ice storm, or terrorist attack? as with each mass casualty event, the answers to this question are location-specific and heavily dependent on the circumstances surrounding the event. however, a common understanding of the goals and concepts of mitigation along with knowledge of its policy history and current practices will help a community develop mitigation plans that are both locally effective and economically sustainable. this chapter illustrates how mitigation strategies have evolved, outlines key historical elements of u.s. mitigation policy, highlights critical current mitigation practices, and describes common pitfalls that can hamper mitigation efforts. the realm of mitigation planning is far reaching and complex, and, therefore, the emphasis of this chapter is on the continuity of medical care during a mass casualty event within a community. in the simplest of terms, mitigation means to lessen the possibility that a mass casualty event can cause harm to people or property. however, this simple definition covers a broad range of possible activities. for example, an effort to ensure that essential utilities, such as electricity and phone service, continue to be available throughout a natural disaster is very different from efforts to minimize the economic damage of postdisaster recovery from a major flood or attempts to educate the public on how to reduce their risk of exposure during a dirtybomb incident. mitigation strategies can range from focusing exclusively on "hardening" to focusing more on resiliency. hardening of targets is best described as measures that are taken to physically protect a facility, such as bolting down equipment, securing power and communications lines, installing backup generators, placing blast walls, or physically locking down and securing a facility. mitigation through hardening has only limited use in systems or facilities such as hospitals where open access to the surrounding community is the hallmark of their operations. in these circumstances, a resilient system capable of flexing to accommodate damage and the ability to maintain or even expand current operations will make that system ultimately more secure. mitigation through resiliency also has limitations. in many cases, hardening structures is most appropriate, particularly when many citizens may be quickly affected without prior notice or warning. this may include hardening structures in earthquake zones, physically protecting and monitoring the food chain and drinking water systems, and physically securing and protecting nuclear power plants. in these cases, resiliency may come too late to prevent illness and death in large numbers of patients, and planners should target hardening to whatever degree is practically and financially feasible. the threats of nuclear, radiological, chemical, and biological attacks present new challenges for emergency planners. the potentially covert nature of the attack, the wide variety of possible agents (including contagious agents), and soft civilian targets make planning efforts exponentially more difficult than in the past. this complexity has also eroded the distinction between mitigation and response activities. although it is never possible to mitigate or to plan responses for all contingencies, we do know, however, that there is a basic common response framework. this framework includes coordination, communication to enable inter-agency information sharing, 1 and flexibility to rapidly adapt emergency plans to different sitvations. traditionally, mitigation in the united states has focused on natural disasters; however, early mitigation planning against manmade disasters included civilian fallout shelters and the evacuation of target cities if a nuclear attack was eminent. the federal emergency management agency (fema) states 2 : mitigation is the cornerstone of emergency management. it's the ongoing effort to lessen the impact disasters have on people's lives and property through damage prevention and flood insurance. through measures such as; zoning restrictions to prevent building in hazard zones (e.g. flood plains, earthquake fault lines), engineering buildings and infrastructures to withstand earthquakes: and creating and enforcing effective building codes to protect property from floods, hurricanes and other natural hazards, the impact on lives and communities is lessened. mitigation begins with local communities assessing their risks from recurring problems and making a plan for creating solutions to these problems and reducing the vulnerability of their citizens and property to risk. 3 however, since the mid-1990s, mitigation planning has become increasingly more complex. terrorist attacks, industrial accidents, and new or reemerging infectious diseases are just a few of the threats that have started to consume more planning time and resources. the growing scope of threats that must be addressed in mitigation strategies challenges all aspects of planning and response at all levels of government. [4] [5] [6] the importance of sharing intelligence information at the earliest possible stage of a terrorist attack, especially a bioterrorism event, is now recognized in national policy as a critical mitigation asset. theoretically, if there were the slightest indication of a contagious biological attack occurring within the united states, then early recognition triggered by intelligence alerts followed by appropriate local responses could allow for isolation, treatment, and containment of a potentially widespread event. this intelligence sharing must become a large part of mitigation efforts aimed at limiting the effectiveness of manmade disasters. a similar analogy can be made with the early warning given to the medical community when a surveillance system picks up an unusual cluster of illnesses, long before the initial diagnosis may be made at a physician's office or healthcare facility. the new national incident management system (nims) states that intelligence must be shared within the incident management structure and states that a sixth functional area, or incident command system section, covering intelligence functions may be established during the time of an emergency. the elevated status of intelligence within nims establishes the importance of early and effective intelligence sharing. the challenge is to establish these sharing relationships before the disaster by incorporating them into an ongoing hazard monitoring process and by integrating them into drills, exercises, and day-to-day activities to ensure that this critical resource is operational when needed to mitigate the consequences of a disaster. 7 the disaster mitigation act of 2000 (dma-2000) elevated the importance of mitigation planning within communities by authorizing the funding of certain mitigation programs and by involving the office of the president. under dma-2000, the president may authorize funds to communities or states that have identified natural disasters within their borders and have demonstrated public-private natural disaster mitigation partnerships. dma-2000 provides economic incentives through promoting awareness and education to prioritize the following objectives for federal assistance to states, local communities, and indian tribes: • forming effective community-based partnerships for hazard mitigation purposes • implementing effective hazard mitigation measures that reduce the potential damage from natural disasters • ensuring continued functionality of critical services • leveraging additional nonfederal resources in meeting natural disaster resistance goals • making commitments to long-term hazard mitigation efforts to be applied to new and existing structures this important legislation sought to identify and assess the risks to states and local governments (including indian tribes) from natural disasters. the funding would be used to implement adequate measures to reduce losses from natural disasters and to ensure that the critical services and facilities of communities would continue to function after a natural disaster. 8 further evidence of the expanding complexity of mitigation efforts can be found in the terrorism insurance risk act of 2002. this act fills a gap within the insurance industry, which typically does not provide insurance coverage for large-scale terrorist events. the federal government, in the wake of the sept. 11, 2001, attacks, promptly passed this act, addressing concerns about the potential widespread impact on the economy. the act provides a transparent shared public-private program that compensates insured losses as a result of acts of terrorism. the purpose is to "protect consumers by addressing market disruptions and ensure the continued widespread availability and affordability of property and casualty insurance for terrorism risk; and to allow for a transitional period for the private markets to stabilize, resume pricing of such insurance, and build capacity to absorb any future losses, while preserving state insurance regulation and consumer protections." 9,10 effective mitigation planning now is expected to include many different aspects of private industry. private industry is a critical partner; its involvement may range from being a potential risk to the community, such as a chemical plant, to providing assistance in responding to an event. this is especially true in the area of healthcare; most healthcare in the united states is provided by the private sector. it is important to note that the national fire protection association (nfpa) recently released nfpa 1600,standard on disaster/emergency management and business continuity programs, 2004 edition. this standard establishes a common set of criteria for disaster management, emergency management, and business continuity. planners may use these criteria to assess or develop programs or to respond to and recover from a disaster. 11 although mitigation planning has become an essential feature of nearly every industry and institution in the wake of sept. 11, 2001, healthcare settings are disproportionately affected by new challenges and complexities in mitigation. the severe acute respiratory syndrome (sars) outbreak shook the foundation of mitigation and prevention in healthcare when healthcare workers and first responders in china and canada died in 2003 after caring for patients with the sars virus. access to several toronto area hospitals was significantly limited for several months because of illness, quarantined staff, and concerns about contamination. the economic costs to the city of toronto were in the billions of dollars. hospitals and their communities were thrown into a complex mitigation and prevention crisis. the association of state and health officials (astho) has come out with specific guidelines and checklists to help prepare states and communities prepare for a possible outbreak. 12 pan-influenza planning closely parallels sars planning, with considerable effort toward preventive vaccination of the population and emphasis on protecting healthcare workers. 13 effective strategies were learned during the toronto sars outbreak, although it was definitely a "learn-as-you-go-along" situation. the most effective mitigation strategies to prepare for the consequences of an outbreak would be to plan for the home quarantine of patients, establish public information strategies to reduce public concern, to close affected facilities until the knowledge base permitted their safe reopening, plan for a coordinated information and command and control center, and have preestablished protocols and procedures in place to protect the health of healthcare workers and first responders. 14 vaccination is an essential component of hospital and community mitigation planning. during the fall of 2002, the u.s. government requested that all states prepare for a smallpox attack. the preparations called for each state to present a plan within 10 days to vaccinate all persons within the state, starting with healthcare workers. 15 each facility and community needs to look at the risk of a disease, the effect of vaccination on healthcare workers, and the ability to maintain continuity of care. if properly informed, healthcare workers could respond and treat patients without risk to themselves or their families. the availability of a vaccination and the ability to mass vaccinate the majority of the population should be considered in all community response plans. the plans for both sars and paninfluenza now need to address the availability and possible stockpiling of antiviral agents as well as procedures for mass vaccination of the population, if a vaccine were to become available. we have learned much from the many earthquakes, tornadoes, hurricanes, fires, and floods that the united states has experienced, but it is extremely difficult to plan for terrorist and natural events that can quickly overwhelm communities, states, or even the whole nation. these historical events, policy developments, and shifts in public attention have created a very complex planning and operating environment. the next section of this chapter addresses some of the key current practices that mitigation strategists should consider. current mitigation strategies are as varied as the circumstances in which they are formed. this section illustrates the impact of mitigation through a comparison of responses to two earthquakes that were broadly separated in geography and community preparedness. these examples are followed by a discussion of critical elements of mitigation and risk reduction practice in three broad categories: coordination with other organizations and jurisdictions, hospital concerns, and mitigation strategies based in community health promotion and surveillance. the first step for protecting communities and their critical facilities against earthquakes is a comprehensive risk assessment based on current seismic hazard mapping. this determination of location should also include the assessment of underlying soil conditions, the potential for landslide, and other potential hazards. 15 communities located on seismic fault lines must also develop and enforce strict building codes. after the bam, iran, earthquake, a large section of the city, at first glance, looked like a burned forest with only the bare trees left standing. it soon became clear that these were steel vertical beams standing upright in mounds of concrete rubble. in comparison, after the northridge, calif., earthquake many of the buildings were structurally compromised but did not collapse on their occupants. undoubtedly, this was the result of the strict building codes and enforcement throughout the state of california. to the victims of the bam earthquake, the most important lifesaving measures may have been the development and enforcement of strict building codes. 16 building codes are minimum standards that protect people from injury and loss of life from structural collapse. they do not ensure that normal community functioning might continue after a significant event. 17 structural protection of facilities requires the active role of qualified and experienced structural engineers during planning, construction, remodeling, and retrofitting. the immediate response of a structural engineer after a disaster is to assess building damage and to assist in determining the need for evacuation and the measures needed to ensure continuity of function. extensive analysis of seismic data taken during an earthquake that are compared with subsequent building damage has given structural engineers valuable information on structural failures of buildings. this information allows communities to rebuild with better and stronger facilities. 18 the following measures to protect the structural integrity of a facility should be in place before an incident 19 : • a contract with a structural engineering firm to participate in planning, construction, retrofitting, and remodeling • a contractual agreement guaranteeing the response, after an event, of a structural engineer (with appropriate redundancy) to ensure structural stability, to assess the need for evacuation, and to take additional measures to ensure the continuity of essential functions • inventory and classify all buildings • conduct a vulnerability assessment • ensure code compliance • determine public safety risks • determine structural reinforcement needs, and prioritize them • prepare lists of vulnerable structures for use in evacuation and damage assessment extensive resources and technical assistance for structural earthquake protection are available on the internet. fema's web site itemizes these resources into three major categories: earthquake engineering research centers and national earthquake hazards reduction program-funded centers, earthquake engineering and architectural organizations, and codes and standards organizations. 20 fema has released the risk management series publications, which provide very specific guidance to architects and engineers about protecting buildings against terrorist attacks. 21 the institute for business and home safety is also an excellent source of incident-specific information for both businesses and homes. 22 the protection of facilities from earthquake damage also involves protecting the facility's nonstructural elements. these nonstructural elements do not comprise the fundamental structure of the building (box 21-1). primary damage to nonstructural elements may be the result of overturning, swaying, sliding, falling, deforming, and internal vibration of sensitive instruments. relatively simple measures, which do not require a structural engineer, may be taken to prevent damage to or from nonstructural elements. these measures may include fastening loose items and structures, anchoring top-heavy items, tethering large equipment, or using spring mounts. other elements, such as stabilizing a generator from vibration damage by placing it on spring mounts or from sliding damage by having slack in attached fuel and power lines, may require the assistance of an engineer. hospitals and other medical care facilities are especially vulnerable to damage from nonstructural elements. consider the placement of routine medical care items such as intravenous poles, monitors/defibrillators, and pharmaceutical agents and medical supplies on shelves. loss of emergency power to key services, such as computed tomography scanners, laboratory equipment, and dialysis units, may also significantly affect the continuity of medical care (e. aur der heide, personal communication, february 2005). 23 loss of generator power may be due to failure of crossover switches, loss of cooling, or loss of connection of power and fuels lines. a process for the continual review of the power needs of new and critical equipment should be a part of a hospital's emergency planning process. cooperating with the federal government and understanding the resources, structure, and timeframe in which the federal resources are available are critical to appropriate mitigation planning. 24 nims and the national response plan are described elsewhere in this book. each document describes in detail the organizational structure and response authority of the federal government in the time of a disaster. 25, 26 healthcare organizations, communities, and states are mandated to ensure that their strategies for mitigation, response, and recovery are developed in coordination with these national models. presidential decision directive homeland security presidential directive (hspd) #5 mandates that by fiscal year 2005,"the secretary shall develop standards and guidelines for determining whether a state or local entity has adopted the nims, " 27 and all mitigation and risk reductions strategies should be designed accordingly. in addition to efforts to coordinate with federal plans, mitigation strategists must also build functional partnerships within communities and across jurisdictional lines. this point has been emphasized in several recently published planning guides. 17, [28] [29] [30] these guides help hospitals and their communities plan for mass casualty events by incorporating key features of planning, risk assessment, exercises, communications, and command and control issues into functional and operational programs. hospitals also present special challenges. presidential decision directive hspd #8 specifies that hospitals qualify as first responders. 31 as such, they have important mitigation activities to consider. what does mitigation mean for a hospital? in the current threat environment, it means minimizing the impact of an event on the institution and ensuring continuity of care. accessibility to the public 24-hours a day, seven days a week has been a hallmark of hospital emergency care. however, one of the most important mitigation strategies a hospital can adopt is the ability to limit and control access to patients and families during the time of a mass casualty or a hazardous materials event. additionally, facilities must have plans and the ability to decontaminate patients, protect essential staff and their families, handle a surge of patients with complimentary plans for the forward movement of patients to surrounding areas, set up alternative treatment facilities within the community, to train staff in early recognition and treatment of illness or injury related to weapons of mass destruction, and ensure continuity of care and financial stability during and after an event. although hospitals will always form the cornerstone for medical treatment of patients during mass casualty events, best practices for hospitals must now also incorporate healthcare resources within the community. 32 hospitals will have to work with other first responders within the community to conduct drills and exercises that realistically test the whole hospital's ability to respond to a mass casualty event. 33 hospitals also will have to ensure that staff members have the proper training to complete hazard vulnerability assessments 34 and to set up and staff outpatient treatment facilities to ensure continuity of care. 35, 36 even with very careful planning, most communities will be overwhelmed for the first minutes to hours or possibly days after a massive event, until an effective and prolonged response can occur. communities must also look at the continuity of medical care as a communitywide issue and not just emphasize the hospital or emergency medical services aspects of medical care. the loss of community-based clinics, private medical offices, nursing homes, dialysis units, pharmacies, and visiting nurse services can significantly increase the number of patients seeking care at hospitals during a mass casualty event. risk communication and education, specifically aimed at protecting the affected population, can help prevent surges of medical patients. 1 hospitals now have enormous community responsibilities in terms of preparing for and mitigating mass casualty events. hospitals in hurricane, flood, earthquake, and tornado zones have prepared for many years against these threats. however, a pattern of repeated systems failures within hospitals continues and includes communications and power loss, with additional physical damage to the facility. 37 to prevent such failures, hospitals need to recognize that mitigation and risk reduction planning must approach the level of detail and logistical support that parallels military planning. surveillance is another key mitigation strategy for health emergencies. early recognition of sentinel cases in biological events can significantly affect the outcome, particularly in contagious events. states are funded and required to participate in the surveillance programs mandated in cdc and health resources and services administration guidelines. 38, 39 the earlier an event is recognized, especially if it involves a contagious disease, the earlier treatment can begin and preventive measures can be taken to prevent the spread of illness to healthcare workers and responders, as well as the rest of the community. public health departments are critical to establishing relationships between local providers and their communities. local, state, and federal public health agencies must ensure that effective surveillance at the community level occurs. these agencies can also assist in awareness-level and personal protection training for hospital staff, emergency medical service employees, and law enforcement first responders. motivating healthcare facilities to take part in mitigation is one of the largest challenges in disaster medicine. it is always best to take measures beforehand to minimize property damage and prevent injury and death. in the case of hospitals, some preliminary research indicates that four factors affect an institution's motivation to mitigate: influence of legislation and regulation, economic considerations, the role of "champions" within the institution, and the impact of disasters and imminent threats on agenda-setting and policy making. it was discovered during this research that "mitigation measures were found to be most common when proactive mitigation measures were mandated by regulatory agencies and legislation." 40 tax incentives, government assistance grants, and building code and insurance requirements may also serve to motivate administrators and decision makers to put the necessary time and effort into mitigation planning. 17 extensive mitigation activities are a necessary prerequisite for the response and recovery activities that must follow a large-scale mass casualty event. we have never seen the number of casualties in the united states we are preparing for today. we do have the threat of an enemy who will strike within the united states with the purpose of inflicting mass numbers of casualties on the civilian population. we must maintain the perspective that even the smallest chance of such an incredibly devastating event, whether manmade or natural, warrants our full attention. if there is no other motivating factor, the possibly such an event must suffice. principles of hospital disaster planning smallpox response plan and guidelines (version 3.0) severe acute respiratory syndrome (sars) biological and chemical terrorism: strategic plan for preparedness and response. recommendations of the cdc strategic planning workgroup federal emergency management agency. the disaster mitigation act of terrorism risk insurance act of insuring against terror? nfpa standard on disaster/ emergency management and business continuity programs association of state and territorial health officials and national association of county and city health officials. state and local health official epidemic sars checklist association of state and territorial health officials. preparedness planning for state health officials sars transmission and hospital containment. emerg infect dis federal management emergency agency. mitigation ideas: possible mitigation measures by hazard type, a mitigation planning tool for communities personal observations during deployment: dmat nm#-1 northridge earthquake community medical disaster planning and evaluation guide: an interrogatory format. am coll emerg physicians data acquisition for earthquake hazard mitigationabstract. presented at: international workshop on earthquake injury epidemiology for mitigation and response governor's office of emergency services. hospital and earthquake preparedness guidelines federal emergency management agency, national earthquake hazards reduction program. publications and resources federal emergency management agency, mitigation division institute for business and home safety technical guidelines for earthquake protection of nonstructural items in communication facilities. bay area regional earthquake preparedness project (barepp) federal emergency management agency, response and recovery. a guide to the disaster declaration process and federal disaster assistance national incident management system homeland security presidential directive/hspd-5: management of domestic incidents it takes a community: the army's integrated bioterrorism response model. frontline first responder medical disaster conference. coordination draft: conference report improving local and state agency response to terrorist incidents involving biological weapons homeland security presidential directive/ hspd-8: national preparedness joint commission on accreditation of healthcare organizations. health care at the crossroads: strategies for creating and sustaining community-wide emergency preparedness systems revised environment of care standards for the comprehensive accreditation manual of hospitals analyzing your vulnerability to hazards acute care center: a mass casualty care strategy for biological terrorism incidents neighborhood emergency help center pamphlet: a mass casualty care strategy for biological terrorism incidents. available at hospital responses to acute-onset disasters: a review. prehospital disaster med department of health and human services,health resources and services administration. national bioterrorism hospital preparedness program continuation guidance for cooperative agreement on public health preparedness and response for bioterrorism-budget year five disaster mitigation in hospitals: factors influencing decision-making on hazard loss reduction guidelines for vulnerability reduction in the design of new health care facilities principles of disaster mitigation in health facilities protecting new health care facilities from disasters key: cord-308968-m4pzsfkd authors: mercadante, amanda r.; yokota, mai; hwang, angela; hata, micah; law, anandi v. title: choosing evolution over extinction: integrating direct patient care services and value-based payment models into the community-based pharmacy setting date: 2020-07-24 journal: pharmacy (basel) doi: 10.3390/pharmacy8030128 sha: doc_id: 308968 cord_uid: m4pzsfkd the american healthcare payment model introduced pharmacy benefit managers (pbms) into a position of power that currently puts into question the state of the pharmacy profession, especially in the community field. reimbursement plans had been designed to benefit all stakeholders and save patients money but have only been shown to increase costs for these involved parties. there exist unresolved gaps in care as a result of the healthcare structure and underutilized skills of trained pharmacists who do not have the federal means to provide clinical services. four collaborative payment models have been proposed, offering methods to quell the monetary problems that exist and are predicted to continue with the closure of community pharmacies and sustained influence of pbms. these models may additionally allow the expansion of pharmacy career paths and improve healthcare benefits for patients. with a reflective perspective on the healthcare structure and knowledge of positive impacts with the inclusion of pharmacists, solutions to payment challenges could present a progressive approach to an outdated system. the impact of the covid-19 pandemic highlights a dependency on pharmacists and community settings. this outlook on pharmacists may persist and an established expansion of services could prove beneficial to all healthcare stakeholders. according to a study published in the journal of the american medical association (jama), 1 in 8 pharmacies in the u.s. have closed down from 2009 to 2015 [1] . the california society of health-system pharmacists (cshp) presented that in the previous two years, an estimated 1 in 6 pharmacies had closed in the state of california alone. one substantial factor deemed responsible for these closures was the current reimbursement practice enforced by pharmacy benefit managers (pbms). pharmacists have noted that this reimbursement model is now antiquated, centered solely around the transactional dispensing of products. the pharmacy profession has reacted and expanded by transitioning its professionals into more clinical roles, however, the payment for clinical services remains underdeveloped. this paper aims to outline the issues with the current payment structure within the united states (us), its impact throughout the pharmacy profession, and to introduce adapted payment models that offer alternative approaches in the pharmacy profession; these include strategies from value-based payment (vbp) structures and integrated business models. patient prescription information remains unknown to the health plan until the medication is filled and filed as a pharmacy claim or when the physician releases the information to the health plan directly from its office records. there is no documented method that can adequately and inexpensively measure if patients are taking their medication exactly as directed. adherence calculators have been utilized using pharmacy refill data; however, they do not accurately assess if patients are taking their medications correctly. bioassays and digital chips in tablets are alternative examples of intrusive and expensive options. patients and primary care providers often do not know the cost of their medications. with numerous health plans and pbms managing each formulary, prescribers are not aware of each patient's preferred medication on formulary. this information can be provided to the patient, but they must call their health plan or related pbm directly. the patient also is not told the price of their medication until the pharmacy calculates the prescription through their computer system. 4. upon receiving a prescription, a pharmacy is not always informed about the medication indication; exceptions exist in certain states where prescribers are required to write diagnosis codes directly on controlled prescriptions. without a requirement for all states regarding all medications, the use for a medication can be unknown to both patient and pharmacist, especially if used for an off-label indication. there is a clear barrier within the process of informing the pharmacy what the prescriber's office has intended the medication to treat. in addition to prescription verification responsibilities in the community setting, pharmacists are required to offer counseling services to patients. the scope of practice for pharmacists expanded into patient education with the legislation of the omnibus budget reconciliation act of 1990 (obra-90). this act may have expanded pharmacist-provided work unrelated to dispensing, but it did not acknowledge or suggest any payment for pharmacists to provide this patient-centered and time-consuming service. furthermore, the reimbursement for products to pharmacies comprises just a small dispensing fee. pharmacists are now approved for increased responsibility through regulations in certain states. california implemented sb 493, which recognizes pharmacists as healthcare providers. washington enacted sb 5557 which improves access to pharmacist services by requiring the inclusion of pharmacists in health insurance provider networks. through hb 2028, oregon grants pharmacists provider status and allows for the reimbursement of performed clinical services. despite this forward movement in the profession, pharmacists are still separated from other healthcare professionals [such as nurse practitioners (np) and physician assistants (pa)] because they do not have the federal provider status that enables billing for services directly to centers of medicare and medicaid (cms). the current healthcare payment system consists of different stakeholders with varied interests in medicine and business. prior to the rise of pbms, cash flow started with cms (previously "hcfa") or specific employers who provided health benefits for employees/enrollees through contracts with pharmacy 2020, 8, 128 3 of 14 "insurance plans," later known as "health plans" (figure 1 ). insurance plans would then allocate payments to hospitals, medical offices, and pharmacies based on utilization and processed claims. pharmacies paid their contracted wholesalers for providing their medications within the inventory while the insurance plans reimbursed pharmacies for drug costs and dispensing fees. the current healthcare payment system consists of different stakeholders with varied interests in medicine and business. prior to the rise of pbms, cash flow started with cms (previously "hcfa") or specific employers who provided health benefits for employees/enrollees through contracts with "insurance plans," later known as "health plans" (figure 1 ). insurance plans would then allocate payments to hospitals, medical offices, and pharmacies based on utilization and processed claims. pharmacies paid their contracted wholesalers for providing their medications within the inventory while the insurance plans reimbursed pharmacies for drug costs and dispensing fees. as managed care prevalence increased and the amount of prescriptions grew in parallel, health plans found processing the large volume of claims to be unmanageable on their own. they chose to delegate this task to pbms, thus introducing pbms into the health payment system as a major player ( figure 2 ). pbms were established in the late 1960s and were involved only in adjudicating pharmacy claims as the partner data warehouse. by the late 1980s, pbm roles began to evolve in conjunction with their responsibility for handling an increased volume of data [3] . pbms began managing the medication formulary, choosing default medications in pharmacy inventories, and influencing which medications became the preferred choices by insurance plans. this role also established a new collaboration between the pbms and pharmaceutical manufacturers who began leaning on pbms to include their newly launched drugs into formularies. the incentive involved selecting drugs from a particular company as the preferred product when using a determined rebate system. currently, as managed care prevalence increased and the amount of prescriptions grew in parallel, health plans found processing the large volume of claims to be unmanageable on their own. they chose to delegate this task to pbms, thus introducing pbms into the health payment system as a major player ( figure 2 ). pbms were established in the late 1960s and were involved only in adjudicating pharmacy claims as the partner data warehouse. by the late 1980s, pbm roles began to evolve in conjunction with their responsibility for handling an increased volume of data [3] . pbms began managing the medication formulary, choosing default medications in pharmacy inventories, and influencing which medications became the preferred choices by insurance plans. this role also established a new collaboration between the pbms and pharmaceutical manufacturers who began leaning on pbms to include their newly launched drugs into formularies. the incentive involved selecting drugs from a particular company as the preferred product when using a determined rebate system. currently, pbms do not only manage formularies, collect and analyze data, and adjudicate pharmacy claims, but are heavily responsible for the negotiation of drug prices, determining reimbursements, establishing prior authorization criteria, pbms do not only manage formularies, collect and analyze data, and adjudicate pharmacy claims, but are heavily responsible for the negotiation of drug prices, determining reimbursements, establishing prior authorization criteria, and forming pharmacy networks. their income is ingrained in every piece of the model, reaching into health plans, pharmacies, and pharmaceutical companies. to illustrate the impactful presence of pbms in this system, the three largest pbms in the us cover more than 180 million lives (76% of the population) [4] . furthermore, the biggest pbms are included in fortune 500′s top 10 companies every year [5] . pbms have also become involved in vertical integration with health plans, chain pharmacies, specialty pharmacies, mail order pharmacies, and wholesalers. there are a few pathways by which pbms have impacted pharmacy reimbursement and patient care. one method involves routing patients into using mail order pharmacies that are owned or controlled by the pbms. the incentive for patients is a lower copay for a 90-day supply (costing the price of only a 60-day supply) through mail order. community pharmacies may offer their own 90day supply savings along with health plans. mail order not only decreases utilization of community pharmacies, but it also decreases the in-person interactions patients have with pharmacists. many patients are greatly impacted by face-to-face counseling and require this intervention to maintain to illustrate the impactful presence of pbms in this system, the three largest pbms in the us cover more than 180 million lives (76% of the population) [4] . furthermore, the biggest pbms are included in fortune 500 s top 10 companies every year [5] . pbms have also become involved in vertical integration with health plans, chain pharmacies, specialty pharmacies, mail order pharmacies, and wholesalers. there are a few pathways by which pbms have impacted pharmacy reimbursement and patient care. one method involves routing patients into using mail order pharmacies that are owned or controlled by the pbms. the incentive for patients is a lower copay for a 90-day supply (costing the price of only a 60-day supply) through mail order. community pharmacies may offer their own 90-day supply savings along with health plans. mail order not only decreases utilization of community pharmacies, but it also decreases the in-person interactions patients have with pharmacists. many patients are greatly impacted by face-to-face counseling and require this intervention to maintain motivation to take their medications and to improve their long-term health care [6] . if mail order is to be implemented to satisfy both dispensing and educational needs, patient care and adherence need to be deliberately addressed to avoid potential consequences of distancing patients from pharmacists. in addition, depending on the health plan and pbm, the patient may be limited to a specific chain of pharmacies in order for their medication to be covered. this action may also limit the competitive ability for a patient to search for affordable medications and preferable individualized care from different pharmacies. the mandated direct and indirect remuneration (dir) fees have also caused a ripple effect monetarily on community pharmacy settings and their patients. an example is illustrated in figure 3 . these fees were initiated when cms created medicare part d in 2006 and were designed with the intention to pass along savings from the pbms or medicare part d sponsors back to cms [7] . the plan included returning savings back to medicare beneficiaries by setting lower prices for medications. according to cms, dir fees include the following: discounts, chargebacks, rebates, cash discounts, free goods contingent on a purchase agreement, upfront payments, coupons, goods in kind, free or reduced-price services, grants, or other price concessions or similar benefits offered to some or all purchasers from any source, including manufacturers, pharmacies, enrollees, or any other person. dir fees accounted for any savings that would serve to decrease the costs incurred by the part d sponsor for the drug [8] . although the aforementioned issues show a more immediate impact on community-based pharmacies, the effect of community pharmacy closures may reverberate throughout the profession. a few scenarios in affected settings and populations within the us are highlighted below. community pharmacies are seeing a direct impact with decreased reimbursements and increased dir fees. moreover, the closure of these pharmacies leaves fewer job opportunities for graduating and practicing pharmacists and technicians. as a result, the prescription volume per staff in the remaining community pharmacies must increase to accommodate those patients forced out of their previous pharmacies. increased prescription volume and stress for pharmacists could lead to errors of judgment, mistakes, and significant adverse drug events now seen in large-volume pharmacies [13] . with a reduction in the numbers of community pharmacies, patients may experience longer wait times at pharmacies, reduced access to medications, and face-time with pharmacists; subsequently, these may lead to more "medication misadventures." without the convenience of a community pbms have been afforded the scope to enforce fees to commercial insurances in addition to part d coverage. community pharmacies are fined dir fees under numerous different names such as network access fees, administration fees, or service fees. oftentimes, these imposed fees are unknown to the pharmacy because there is no regulation, rule, or explanation on how and why these fees are determined. additionally, these fees are charged retroactively which means that several months after dispensing the medication, the pharmacy is expected to make a payment the pbm demands ( figure 1 ) [9] . legislation has allowed for zero oversight for any fees charged to pharmacies by pbms [10] . this generous circumstance seems less of a coincidence when acknowledging that pbms have paid usd 1.49 billion in lobbying during just the first three months of 2019 [11] . according to a cms analysis, dir fees have increased 1600% in the last five years and have amounted to usd 8.5 billion since 2013 [12] . the financial gain by pbms has not been reflected in savings by medicare part d beneficiaries despite the originally advertised plan to save patients money. the true direction and distribution of these fees are unknown because there is no regulation to ensure that any cost savings the pbm collects ultimately gets passed onto the patients. in fact, medicare patients continue to incur more out of pocket costs for prescription drugs with the existence of these fees [12] . although the aforementioned issues show a more immediate impact on community-based pharmacies, the effect of community pharmacy closures may reverberate throughout the profession. a few scenarios in affected settings and populations within the us are highlighted below. community pharmacies are seeing a direct impact with decreased reimbursements and increased dir fees. moreover, the closure of these pharmacies leaves fewer job opportunities for graduating and practicing pharmacists and technicians. as a result, the prescription volume per staff in the remaining community pharmacies must increase to accommodate those patients forced out of their previous pharmacies. increased prescription volume and stress for pharmacists could lead to errors of judgment, mistakes, and significant adverse drug events now seen in large-volume pharmacies [13] . with a reduction in the numbers of community pharmacies, patients may experience longer wait times at pharmacies, reduced access to medications, and face-time with pharmacists; subsequently, these may lead to more "medication misadventures." without the convenience of a community pharmacy to receive services, there may be increased reliance on hospital emergency departments and possibly more hospital admissions due to misadventures. this influx of patients could consequently increase the workflow for hospital staff and patient wait times in this setting as well. if patients are not being managed in community pharmacies, patient prioritization may need to be delegated to emergency visits, transitions of care, and other clinics. patients, the ultimate recipients of health care, may be impacted the most by these aforementioned community pharmacy closures. a general reduction in the number of stores could result in less access for patients and decreased convenience; as stated previously, the consequences may include a dramatic increase in travel and wait times. patients may also be motivated to call their primary care providers instead of the busy pharmacists, leading to an increased call burden at doctor offices. some patients, especially those at higher risk, may require individualized attention or specialized care. reduced access to this level of care due to fewer options could result in adverse patient outcomes. with fewer community pharmacy options and potential increased burden on primary care providers, the need for ambulatory care clinics may drastically increase. patients will need proper intervention and information to reach goal adherence while understanding their health needs. pharmacists working in telehealth and medication therapy management (mtm) may become the needed members of the patients' individualized healthcare team if the community pharmacies are employed predominantly for dispensing purposes. the direct impact on student pharmacists continues with fewer opportunities to gain experience and pursue a career in the community setting. the ability of rotation sites to provide practice experiences may be limited with the decreasing number of available pharmacies to precept students. students will likely be shifted away from community pharmacy jobs and pushed to consider other career paths such as industry, research, and ambulatory care. the career prospects of pharmacy may change for many who envisioned a career in community pharmacy and the exponentially growing number of graduating students could face a more difficult task in paying off student loans. additionally, the job market for pharmacists may not present paid positions for interns within their company if there are no open positions awaiting them as pharmacists. the pharmacies will not have the resources to train student interns that they cannot hire. a combination of these previously described obstacles may lead to the decreased quantity and possibly quality of applicants for pharmacy schools. recognition of a highly competitive job market with a doctor of pharmacy (pharm.d.) degree may lead to a decreased applicant pool. rotation sites may also be burdened with higher student ratios per preceptor if other sites are no longer available. the education of students may need to adapt to the opportunities that await graduates; classes focusing on skills for community pharmacy may take a backseat to allow for further education regarding industry, residential, and research pharmacy skills. this awareness of the professional climate could influence pharmacy programs to change certain aspects of their curriculum and present new elective options. in response to the decrease in reimbursement for dispensing medications, community pharmacists have evolved to find solutions and provide additional services. a list of newly initiated programs is shown in table 1 . one initiative includes retail pharmacy chains partnering with general practitioners (e.g., physicians or nurse practitioners) to set up clinics within pharmacies and see patients for acute conditions. newer online startup pharmacies have been offering free delivery services similar to mail order pharmacies. certain pharmacy chains have also offered lower cash prices on a list of generic medications (e.g., metformin, lisinopril) to patients who do not carry insurance. one pharmacy has teamed up with a pbm, promising no dir fees, no clawbacks, and no hidden charges; utilization of a code suffices as a coupon price for partnering pharmacies and do not require insurance use. the patient can also elect to have the prescription filled online with free delivery for medications. some pharmacies have adjusted their medication stock, no longer ordering those medications for which they will not be reimbursed or have previously lost money from dir fees; these pharmacies direct patients to other pharmacies that may carry the medication on their formulary. other strategies community pharmacies have implemented include the addition of clinical services to their dispensing model. ab 1114 in california encourages pharmacists to provide certifiable services such as furnishing travel medications and birth control. these services can be paid through medi-cal when provided by the certified pharmacists [14] . another currently billable service performed by pharmacists includes mtm. while mtm can be reimbursed by a third-party insurance company, the monetary amount may not be equivalent to the investment of time pharmacists require to complete a single mtm encounter. infrequently, private insurance companies will pay for clinical services, but the process for compensation can prove cumbersome, requiring individual contracts with every individual pharmacy location providing mtms. ultimately, pharmacists cannot directly bill medicare for services such as chronic care management or transitions of care because they are not federally recognized as healthcare providers. a collaborative practice agreement (cpa) between a pharmacist and physician is currently the most effective way for a pharmacist to provide specific clinical services; their respective billing codes may allow for payment of those services. "incident-to" billing is required for any outpatient services that a pharmacist is approved to provide after satisfying several requirements: incident-to billing can be conducted by pharmacists only in conjunction with a medicare-approved provider and when in restricted settings (in the same office suite, which usually means not within a community pharmacy); this billing has limits the reimbursement. in addition, the patient must first be seen by a physician; the physician must then authorize the use of the patient's medical record, directly supervise the pharmacist, and remain readily available. this provision of care is also paid as fee-for-service, showing no monetary regard for health outcomes. the authors utilized a variety of methods to develop the following payment models. a literature search identified studies using electronic databases pubmed and international pharmaceutical abstracts (ipa). the search was not specifically limited to any time period but did focus on the most recent us data regarding payment models. the following search terms were utilized: health care payment model, pharmacy model, value-based payment, fee for service, community pharmacy role, pharmacist services, community pharmacy services. a supplementary approach utilizing media (google search engine) and pharmacy newsletters and articles (e.g., american pharmacists association (apha), california pharmacists association (cpha), pharmacy times) presented documented examples of business attempts to resolve payment issues and more current descriptions of actions taken by the pharmacy profession that were not found in the electronic databases. eligibility assessment for relevant articles was conducted independently by the authors and any disagreements were discussed during preliminary development of adapted payment models. in addition, the authors prepared and led a presentation on the gaps in healthcare systems and issues with reimbursement for pharmacists in community-based pharmacies to practicing faculty at a college of pharmacy. based on professional input and discussion with an expert panel of professional society advocacy groups, four gaps were identified. finally, the authors conducted expert interviews between february and april 2020 with four independent pharmacy owners and four health plan administrators. these discussions introduced the authors' proposed models to the professionals and allowed for the collection of valuable stakeholder insight regarding various payment models, opinions on proposed payment models, and challenges and opportunities within each model. after assessing the recorded interviews, four proposed models were filtered, refined, then selected for this paper. summaries of the completed models with their respective pros and cons are listed in table 2 . primary care providers have expanded from medical doctors to include nps and pas. these providers have the authority to diagnose and prescribe medications (based on state laws and scope of practice). in this model, a pharmacist would cohabitate the same office as the pcp, allowing for a one-stop appointment where a patient can have designated time with both professionals. while the pharmacist would be available to directly counsel patients and work with the physician, the dispensing of medications would be kept separate. this option would allow patients to utilize mail order or pick up medications at a pharmacy of their choice or at the behest of the health plan. the compensation for this office-based pharmacist would also be dependent on clinical services. while this model is not novel and has been implemented occasionally in the past, the payment structure may provide new elements. this model has also been proposed by the 2019-2020 president of the american association of colleges of pharmacy (aacp); "his bold aim is that by 2025, 50 percent of primary care medical practices will have integrated comprehensive medication management (cmm) services into their care model, and those services will be delivered by pharmacists [15] ." while mtm services can be billed per patient, the entire healthcare group responsible for taking care of the patient would benefit from collaborative practice; the co-pay for the visit would not only go towards the physician, but the pharmacist as well. while utilizing the idea put forward through collaborative practice agreements and incident-to or value-based payments, these services would be utilized more efficiently and more frequently because of the synergized setup. through this team model, the physicians would be able to focus more on the examinations and diagnostic services while the pharmacist would contribute through medication-related and lifestyle counseling as well as educating the patient about their adherence goals. moreover, pharmacist collaboration could help physicians with quality measures such as healthcare effectiveness data and information set (hedis), merit-based incentive payment (mips), and medicare access and chip reauthorization act (macra) for increased compensation. delegated services would provide a more comprehensive experience and allow for direct communication and organization of patients' medical and lifestyle plans. there would no longer be any gaps or missing information between these professionals concerning patients' diagnoses or medical records. one study demonstrated that mips was able to "reduce administrative burdens, protect practices serving vulnerable populations and improve communication between program administrators and primacy care providers (pcps)," but was limited by the potential movement of clinical resources away from patient-centered care and decreased patient and clinician satisfaction [16] . this study explained that the model would need to demonstrate simplicity in design and allow practical adaptability to prove its benefits outweighed its challenges. pcp interviews revealed that burdens of time and participation, risk of penalties, and over-complication of the administration of an adapted program would be great disadvantages to incorporating a value-based model [16] . similar issues may present themselves in this model as well. additionally, incident-to billing may limit this model due to its stringent requirements, hence other value-based payments may be preferable to health care providers and stakeholders. as previously stated, there exists a gap in communication between a health plan and patient medication records. healthcare is the only industry where the 'consumer' is uninformed of the price for the product prior to purchase other than the co-pay or cost share. this transactional irregularity has resulted in 'surprise billing' for patients who receive multiple and excessive bills from doctors and hospitals. a bill has been proposed to protect patents from receiving large bills called the surprise billing legislation, but at the time of this writing, has not yet been passed [17] . in this proposed payment model, patients would have the option to pay directly with cash or through insurance. if patients have access to the drug price, they can control how and where they would pay. previously, pharmacies were concerned about insurance-only billing due to reimbursement by the pbm. in the proposed scenario, pharmacies would be free to offer patients the best cash price. patients would have the option to pay cash price for their prescriptions and save their insurance dollars for more expensive medications (as insurance was intended to do). this would benefit the health plan payout because they would not be charged for all prescriptions. the transparency model could be optimized with a medication price-tracker for patients. a similar model has been established in certain pharmacies where patients are able to price shop prior to switching to that pharmacy. the transparency model shares similarities with the value-based benefit design implemented by some plan sponsors or pbms; these plans negotiate a lower copay for high value prescriptions (e.g., statins) based upon established patient health outcomes or pre-set financial incentives [18] . the challenge in translating this model to pharmacies is the responsibility of tracking patient outcomes that are conducted by plans or pbms. additionally, this design benefits the larger volume stores that have a bigger bargaining power with wholesalers. an aco-based model with the addition of the patient (acopp) is a shared risk value-based system that distributes accountability for inputs and outcomes among vested parties. until now, acos have included hospitals, physician offices, nurses, and other healthcare professionals that have demonstrated success in cost savings and health outcomes for high-risk patients. however, these models have not included proactive roles involving patients. the authors propose an integrated model with physician, pharmacist, and patient in a modified aco. accountability remains the focus: all parties involved would have shared risk that could result in payment benefits such as lowered copays for patients and monetary rewards for medical providers and pharmacists. if conditions are not met or value is not achieved, the risk could include withholding of payment benefits. the health plan takes risk by offering these payment benefits if goals are achieved, which would be offset by the long-term cost savings associated with improved medical outcomes and a reduction in high cost visits such as hospitalizations and emergency care. for example, a health plan could offer lower premiums to patients for incentivized measures such as documented yearly lab work if required by prescriber and yearly overall documented proportion of days covered (pdc) ≥0.80 for chronic medications. to include the risk aspect, health plans could require higher premiums or withhold low-cost benefits if the patient does not maintain an appointment with a general practitioner and have lab work at least every 2 years, or if the patient's documented annual pdc falls below a specified number. payments could be determined on an annual basis to ensure adequate time for goals to be attained. the major challenge in this model is the full participation of health plans and patients. without all parties involved and actively collaborating, the shared risk could be greater than the shared benefit. patients have been acknowledged as passive receivers of healthcare. this model would require an aspect of motivation; patients would need to be invested and take an active role in their healthcare. accordingly, patients taking responsibility and being proactive could help their long-term outcomes and positively affect their perspective and "locus of control" when actively involved as a member of the team. another challenge exists with the downside risk agreements that are necessary in an aco-like model. downside risks are designated amounts of loss that could occur in an industry or company if the market or item values decline. for example, a healthcare system would be responsible for downside risk if the care exceeds the thresholds set for finances and clinical services. this system provides innate accountability for providers and payers when delivering patient care. the 2018 annual aco survey showed that there is still much disagreement with the adoption of contracts with downside risk and how to compel health care organizations to be more invested in the management of public health [19] . proper contracting and further discussions with medicare and commercial groups would be essential to ensure the success of this type of model. healthcare professionals have utilized a network model in order to best serve communities and provide them with a provider that is available and convenient to their location. toll free numbers allow patients to connect with and seek the help they need when there is a network of professionals involved. community pharmacies serve similar purposes of convenience but are limited to dispensing duties with a small amount of time for counseling per patient. a pharmacy network model could be implemented to connect pharmacists with a variety of clinical services (that are not provided in the community pharmacies) directly to the patients in need. this model would necessitate a call center that has a list of verified pharmacists available for temporary or contract positions. independent pharmacies or companies looking for contract pharmacists for ambulatory or clinical care services would be able to connect with a pharmacist for a negotiated period of time. patients would be able to contact the network to get in touch with a pharmacist for medication-related questions and services. the primary advantages of this model would include addressing the multibillion-dollar medication nonadherence and medication misadventure issues while also highlighting the integral role of the pharmacist. this network would also allow pharmacists currently in different practices who want to transition into clinical roles to receive training and find work opportunities. with the increasing number of graduate pharmacists in the us, these opportunities could provide employment pathways for many new professionals [20] . patients would have appropriate health care from a clinical pharmacist just one phone call away. community pharmacy networks (i.e., cpesn) and companies currently exist that provide services for either patients or healthcare systems such as mtm or medication risk mitigation management, but their focus is on specific services or locations. this network model is broad and would include retail, hospital, and ambulatory care pharmacists. starting a pharmacy network would require a large amount of funding or investment to offset the salaries, benefits, and incentives for pharmacists to join the network. marketing would also be needed to increase awareness of the services and to change patient expectations of pharmacists. the scenarios resulting in the healthcare industry as a result of the covid-19 pandemic have shaped a new outlook for pharmacists that may persist after solutions enable us to address the impact of the disease. the ohio department of health, for example, has created a checklist and new standards for pharmacists; these dictate that the pharmacist is the major influence on everyday patients and will be establishing a precedent of "calmness, knowledge of procedures, and safe protocols" within the pharmacy in addition to the normal duties of counseling, dispensing, and maintaining business operations [21] . the current situation has established great attention on pharmacists and their broadened roles in preventative health. physician offices have closed or reduced hours, reserving appointments for emergencies or high-risk patients, while pharmacies have stayed open. in an effort to increase the span of the healthcare providers, states (e.g., ny, pn, ma) have fast-tracked the abilities of new medical doctors and nurses. pharmacists have been allowed increased services such as conducting health and wellness tests, managing chronic diseases, performing medication management, and administering immunizations [22] . certain retail pharmacies utilize pharmacists to test patients for covid-19, a previously unprecedented task in a community pharmacy [23] . if a vaccine becomes available for covid-19, as expected before the end of 2020, it is likely that community pharmacists will be the major group (if not the only medical group) responsible for administering and counseling patients regarding expectations of the vaccine. patient counseling and education could become even more important and time-consuming for pharmacists in this setting if more than one vaccine is approved for administration. during this time, in a temporarily expanded model, pharmacists have been able to represent their specialized skills and abilities beyond their usual duties. these examples display that pharmacists can fill needed gaps in care through providing clinical services. if supported in the future by provider status and billing for services, the adaptation of a new payment model could properly fit the demands of patients and the healthcare system. the current state of outpatient community-based pharmacies presents many challenges for pharmacists and other stakeholders in us healthcare. the involvement of pbms has altered the structure of healthcare and allowed for their own benefit at a direct cost to community pharmacies. the current methods enforced by pbms with limited governmental regulation will continue to push community pharmacies out of business if they remain in their current position. the challenges with this payment structure and abilities of pharmacists could be viewed as an opportunity to further the practice of pharmacy and influence the healthcare field. the authors propose various payment models that could offer solutions where pharmacists could better control their professional status and profit margins. research and implementation are required to demonstrate the impact of these models. while the models are not necessarily mutually exclusive in ideology, there would be value in testing these with a design that allows comparison to the current payment structure and examination of the outcomes. closures affect 1 in 8 pharmacies in the us: urban, independent pharmacies in low-income neighborhoods most at risk. sciencedaily. 21 overypaying for prescription drugs: the copay clawback phenomenon pbm role in the healthcare marketplace: pbm watch top pbms by market share. available online fortune's 5 most influential pharmaceutical distributors and pbms the asheville project: clinical and economic outcomes of a community-based long-term medication therapy management program for hypertension and dyslipidemia dir fees: pbm watch. available online white paper: dir fees simply explained. pharmacy times direct and indirect remuneration (dir) performance and the impact on pharmacies serving medicare part d beneficiaries: a white paper by inmar intelligence the need for transparency with dir fees pharmacy benefit managers spend record $1.49m on lobbying. becker's hospital review how chaos at chain pharmacies is putting patients at risk. the new york times primary care physicians in the merit-based incentive payment system (mips): a qualitative investigation of participants' experiences, self-reported practice changes, and suggestions for program administrators surprise billing: choose patients over profits value-based pricing to address drug costs annual aco survey: examining the risk contracting landscape|health affairs trends in the numbers of us colleges of pharmacy and their graduates, 1900 to 2014 covid-19 checklist for pharmacies: top 10 things you can do to prepare for covid-19. ohio department of health website massachusetts senate passes bill to expand health care workforce. needham times other retailers to offer covid-19 testing this article is an open access article distributed under the terms and conditions of the creative commons attribution (cc by) license we would like to thank the experts and interviewees for responding and sharing their views. the authors declare no conflict of interest. key: cord-283960-vfnt2o20 authors: walsh, sharon l.; el-bassel, nabila; jackson, rebecca d.; samet, jeffrey h.; aggarwal, maneesha; aldridge, arnie p.; baker, trevor; barbosa, carolina; barocas, joshua a.; battaglia, tracy a.; beers, donna; bernson, dana; bowers-sword, rachel; bridden, carly; brown, jennifer l.; bush, heather m.; bush, joshua l.; button, amy; campbell, aimee n.c.; cerda, magdalena; cheng, debbie m.; chhatwal, jag; clarke, thomas; conway, kevin p.; crable, erika l.; czajkowski, andrea; david, james l.; drainoni, mari-lynn; fanucchi, laura c.; feaster, daniel j.; fernandez, soledad; freedman, darcy; freisthler, bridget; gilbert, louisa; glasgow, lashawn m.; goddard-eckrich, dawn; gutnick, damara; harlow, kristin; helme, donald w.; huang, terry; huerta, timothy r.; hunt, timothy; hyder, ayaz; kerner, robin; keyes, katherine; knott, charles e.; knudsen, hannah k.; konstan, michael; larochelle, marc r.; craig lefebvre, r.; levin, frances; lewis, nicky; linas, benjamin p.; lofwall, michelle r.; lounsbury, david; lyons, michael s.; mann, sarah; marks, katherine r.; mcalearney, ann; mccollister, kathryn e.; mccrimmon, tara; miles, jennifer; miller, cortney c.; nash, denis; nunes, edward; oga, emmanuel a.; oser, carrie b.; plouck, tracy; rapkin, bruce; freeman, patricia r.; rodriguez, sandra; root, elisabeth; rosen-metsch, lisa; sabounchi, nasim; saitz, richard; salsberry, pamela; savitsky, caroline; schackman, bruce r.; seiber, eric e.; slater, michael d.; slavova, svetla; speer, drew; martinez, linda sprague; stambaugh, leyla f.; staton, michele; stein, michael d.; stevens-watkins, danelle j.; surratt, hilary l.; talbert, jeffery c.; thompson, katherine l.; toussant, kim; vandergrift, nathan a.; villani, jennifer; walker, daniel m.; walley, alexander y.; walters, scott t.; westgate, philip m.; winhusen, theresa; wu, elwin; young, april m.; young, greg; zarkin, gary a.; chandler, redonna k. title: the healing (helping to end addiction long-term (sm)) communities study: protocol for a cluster randomized trial at the community level to reduce opioid overdose deaths through implementation of an integrated set of evidence-based practices date: 2020-10-17 journal: drug alcohol depend doi: 10.1016/j.drugalcdep.2020.108335 sha: doc_id: 283960 cord_uid: vfnt2o20 background: opioid overdose deaths remain high in the u.s. despite having effective interventions to prevent overdose deaths, there are numerous barriers that impede their adoption. the primary aim of the healing communities study (hcs) is to determine the impact of an intervention consisting of community-engaged, data-driven selection, and implementation of an integrated set of evidence-based practices (ebps) on reducing opioid overdose deaths. methods: the hcs is a four year multi-site, parallel-group, cluster randomized wait-list controlled trial. communities (n = 67) in kentucky, massachusetts, new york and ohio are randomized to active intervention (wave 1), which starts the intervention in year 1 or the wait-list control (wave 2), which starts the intervention in year 3. the hcs will test a conceptually driven framework to assist communities in selecting and adopting ebps with three components: 1) a community engagement strategy with local coalitions to guide and implement the intervention; 2) a compendium of ebps coupled with technical assistance; and 3) a series of communication campaigns to increase awareness and demand for ebps and reduce stigma. an implementation science framework guides the intervention and allows for examination of the multilevel contexts that promote or impede adoption and expansion of ebps. the primary outcome, number of opioid overdose deaths, will be compared between wave 1 and wave 2 communities during year 2 of the intervention for wave 1. numerous secondary outcomes will be examined. discussion: the hcs is the largest community-based implementation study in the field of addiction with an ambitious goal of significantly reducing fatal opioid overdoses. the current u.s. opioid overdose crisis has been ongoing for two decades, but was only officially declared a national emergency in 2017 (gostin et al., 2017) . however, it is important to note that, since the 1960's, a less well publicized and often neglected opioid crisis has been underway in the u.s., driven largely by heroin use in primarily urban areas and disproportionately impacting minority populations. overdose deaths from prescription opioids, heroin, and illicit synthetic opioids contributed to more than 450,000 deaths from 1999 to 2018 and nearly 47,000 deaths in 2018 alone (seth et al., 2018) . in recent years, the availability and use of illicit fentanyl and fentanyl analogs have accounted for an increasing proportion of opioid overdose deaths (nida, 2019) . one driver of the opioid crisis is the recognized gap between the number of individuals who could benefit from evidence-based treatment and prevention interventions to reduce opioid misuse, opioid use disorder (oud) and associated medical consequences, including overdose deaths, versus those engaged in care. the 2018 national survey on drug use and health estimated conservatively that 2.1 million americans have oud; however, this excludes several highly affected populations (e.g., incarcerated individuals, homeless)(samhsa, 2019). fewer than 20% of those with oud receive addiction care in a given year (samhsa, 2019; wu et al., 2016) . in a cohort of opioid overdose survivors, fewer than one-third received any medication for opioid use disorder (moud) within a year of the overdose event (larochelle et al., 2018) . a number of evidence-based practices (ebps) exist, including: opioid overdose education and naloxone distribution programs (e.g., walley et al., 2013) .; prescription drug monitoring programs and improved professional guidelines to reduce inappropriate opioid prescribing (e.g., bonhert et al., 2018) ; food and drug administration-approved moud including methadone, j o u r n a l p r e -p r o o f buprenorphine, and naltrexone; treatment engagement and retention interventions; and recovery support services (e.g., strang et al., 2020) . many of these ebps have largely failed to penetrate communitty settings where opioid misuse and oud could be addressed, including general medical care, the justice system, social support services, and addiction treatment programs. this failure is, in part, due to a lack of evidence-based approaches to assist communities in the development and deployment of data-driven, community-specific strategies to adopt, deliver, and use integrated ebps. in the us, the substance use treatment gap is a result of at least three major challenges: 1) many individuals with oud do not perceive a need for treatment; 2) there is insufficient treatment capacity; and 3) there is suboptimal treatment retention (williams et al., 2018) . national data indicate that, among individuals with substance use disorders who are not in treatment, a lack of recognition of their disorder is a major impediment to seeking help (ali et al., 2015; olsen and sharfstein, 2014) . a recent report indicated that, of those respondents with opioid misuse, nearly 87% did not perceive a need for treatment (choi et al., 2019) . furthermore, many individuals have internalized stigma about oud that prevents them from seeking treatment (corrigan et al., 2017) . in addition to these challenges, there is limited capacity for delivering moud in many communities. most of the nation's 1,782 opioid treatment programs (otps; e.g., federally licensed methadone programs) are located in urban communities, are not integrated into traditional health care settings, and growth in the number has been modest in the past decade (jones et al., 2015) . buprenorphine, in contrast to methadone, is more widely delivered in office-based addiction treatment in the u.s. and requires a unique license designation known as a waiver (kraus et al., 2011) . the number of u.s. buprenorphine-waivered physicians has increased (knudsen et al., 2017) along with buprenorphine dispensing (alderks, j o u r n a l p r e -p r o o f 2017), but both remain insufficient to meet the need for treatment even with the new provision to allow nurse practitioners and physician assistants to prescribe buprenorphine. for example, according to the dea prescriber data base as of september 2020, there were a total of 1,740,770 civilian physicians, nurse practitioners, and physician assistants active licensed to prescribe controlled substances but, of those, only 85,317 or 4.9% also possessed the waiver to prescribe buprenorphine for oud. in addition, for patients receiving moud, overall treatment retention is poor, and the percentage of those receiving treatment has declined from 25% in 2010 to 16% in 2014 due to increasing numbers of affected individuals (morgan et al., 2018) . finally, access to treatment and ongoing care are further limited by policy barriers, such as required prior authorizations and arbitrary time limits for care. in addition to moud-related challenges, both underutilization of overdose prevention strategies and the opioid-prescribing behaviors of medical professionals that can increase the risk of overdose are significant drivers of the national epidemic. naloxone effectively reverses opioid overdose, thus preventing fatalities (walley et al., 2013) . although demonstration projects have shown that community distribution of naloxone can reduce opioid fatality rates, national data show very limited prescribing of naloxone (including distribution through standing orders at pharmacies) (sohn et al., 2019; xu et al., 2018) . opioid overdose deaths also reflect continuing patterns of risky prescribing, such as concurrent benzodiazepine and opioid prescribing and high opioid doses (i.e., >90 morphine milligram equivalents per day). these prescribing behaviors increase the risk of overdose even among individuals without oud and heighten the risk of developing oud. for these reasons, a study that addresses barriers and facilitators of ebps and their implementation is imperative to change the course of the overdose crisis, particularly for ebps j o u r n a l p r e -p r o o f most likely to have an immediate impact on overdose deaths. the primary aim of the healing communities study (hcs) is to evaluate the effectiveness of a community-engaged intervention on reducing opioid overdose fatalities by deploying an integrated set of ebps through a community-driven process in an array of settings, including behavioral health, healthcare and criminal justice to reach populations vulnerable to opioid overdose. the experimental design also offers an opportunity to extend our understanding of the multi-level factors that mediate or moderate implementation success in heterogenous communities, which vary considerably in their current resources and ongoing response to the opioid crisis. by adapting the reach, effectiveness, adoption, implementation, and maintenance model and practical, robust implementation and sustainability model (re-aim/prism; described below) (aarons et al., 2011; damschroder et al., 2009; greenhalgh et al., 2004; kitson et al., 2008; raghavan et al., 2008; tabak et al., 2012) , the hcs can define system-level interrelationships as well as dynamics within the intervention itself that facilitate successful attainment of reducing opioid overdose deaths. the hcs is a four-year multi-site study with the overarching objective of implementing ebps to significantly reduce opioid-related overdose fatalities in 67 urban and rural communities. the hcs will test the communities that heal (cth) intervention, a conceptually driven framework built upon the evidence-based communities that care model, that assists communities in adopting ebps to prevent drug use and other risky behaviors (oesterle et al., 2018) . the cth intervention seeks to promote a common vision, shared goals, and tailored strategies to mobilize hcs communities to adopt and implement ebps. cth uses a stepwise process to engage community members to implement system-and practice-level j o u r n a l p r e -p r o o f changes, while at the same time delivering communication campaigns to increase awareness and demand for ebps and reduce stigma. secondary outcomes will assess the impact of the cth intervention on increasing naloxone distribution, expansion of moud utilization and reduction of high-risk opioid prescribing practices. the hcs will also examine conceptually driven internal and external contexts for implementation of the cth intervention, including policy; resources at the community, state and national level; treatment guidelines; fidelity of the hcs implementation; and overall cost-effectiveness of the intervention. the hcs is a multi-site, parallel group, cluster randomized wait-list controlled trial testing the impact of the cth intervention. the hcs enrolled 67 communities from four states. this cluster randomized controlled trial treats communities as clusters, allocating each to either the cth intervention or the wait-list comparison group. communities randomized to the cth intervention during the first two years are referred to as wave 1 communities. communities randomized to the wait-list comparison group (wave 2 communities) continue usual care during the first 2 years and begin the cth intervention thereafter. due to the time needed to work with communities and organizations to expand delivery of ebps, a lag is expected from when the cth intervention is introduced into a community to when its effect on key outcomes will be observed. therefore, the primary study outcome compares the randomized groups during year 2 of the intervention in wave 1 communities, referred to as the evaluation period. this study is registered on clinical trials.gov (https://clinicaltrials.gov/ct2/show/nct04111939), registered on october 1, 2019 with first enrollment on oct 23, 2019. people. because no one person or group of people possess(es) the authority to give consent on behalf of all community members, investigators sought expert consultation and applied guidelines from the ottawa statement (taljaard et al., 2013) . because the cth intervention poses no more than minimal risk to community members and the research could not be carried out otherwise (see 45.cfr.46.116), a waiver of informed consent was obtained for all community members who may be affected by the cth intervention. additionally, key stakeholders/participants provided letters of support for community participation prior to funding, and community coalitions completed charters outlining roles and responsibilities of coalition members following randomization. 2) administrative data records: to examine study outcomes, numerous administrative data records will be collected. given the time frame of the study and study population, there will likely be millions of individual health records included, but no individuals will be contacted. thus, a waiver of informed consent and health insurance portability and accountability act waiver were obtained. 3) individual data collection: individuals who provide de novo data (e.g., surveys, interviews) provide informed consent via phone, online or in writing depending on the measure j o u r n a l p r e -p r o o f and data collection process. a partial waiver of consent was obtained for baseline individual data collection. communities across four states (kentucky, massachusetts, new york, ohio) were selected to participate based on the following eligibility criteria established by the national institute on drug abuse: 1) expressed willingness to address the implementation of moud and overdose education and naloxone distribution; 2) expressed willingness to develop partnerships across health care, behavioral health, and justice settings for ebps to address opioid misuse, oud, and overdoses; 3) within each state, ≥30% of selected communities were rural; 4) across the hcs communities in each state, ≥150 opioid-related overdose fatalities (at least 15% occurring in rural communities) and a rate of ≥25 opioid-related overdose fatalities per 100,000 people, based on 2016 data. the communities are either counties (ny, ky, oh) or cities/towns (ma; see figure 1 ). additional state-specific criteria were applied to further refine selection. ky selected counties with: 1) a syringe service program (marker of community readiness); 2) a jail; 3) ≥1 buprenorphine-waivered provider; and 4) ≥5 opioid overdose deaths in 2017. ma selected non-adjacent communities to minimize proximity and contamination, favored communities with an anchor office-based addiction treatment (obat) program and a pre-existing substance use coalition. ny included three urban or semi-urban communities (buffalo, rochester, brookhaven) to ensure geographic diversity and the comparability of population sizes in wave 1 and wave 2 communities. oh selected counties stratified by urban/rural that: 1) were not contiguous and 2) did not share an existing alcohol, drug and mental health board. ky excluded three counties that were actively engaged in two national institutes of health-funded j o u r n a l p r e -p r o o f community-level addiction intervention studies. oh excluded 10 counties for lack of available opioid-related data. the cth intervention has three elements: 1) a community engagement strategy designed 2.4.1. community engagement strategy. the cth intervention is guided by principles of community engagement to build capacity and support the adoption of ebps that are described below. community engagement and partnering with local stakeholders provides researchers with nuanced understandings of community needs, resources, priorities and community norms, thus allowing for implementation of ebps best suited for the community (wallerstein and duran, 2010; wallerstein, 2015) . the cth intervention (see figure 3) consists of an iterative, 7 phase change process for communities that is led by a diverse, multi-sector community coalition. this coalition-led, datadriven, and non-linear planning process is adapted from the communities that care model (hawkins et al., 2009) . the preparatory phase of the cth intervention (phase 0) begins with each hcs research team establishing a multisectoral community advisory board (cab), separate from local coalitions, whose role is to serve in an advisory capacity to the research team. cabs are state-specific and include representation from state agencies and hcs communities. research teams identify existing coalitions or establish new coalitions to partner with in the cth intervention. research teams present an overview of the project including the goals, j o u r n a l p r e -p r o o f randomization, and timeline to community coalitions in both wave 1 and 2 of the study. a landscape analysis conducted by the research teams identifies local resources to address the opioid crisis and inform community planning, which is done in phase 3. phase 1 launches intervention activities in wave 1 communities. research teams lay the groundwork for collaboration by co-creation of a partnership agreement/charter to outline key milestones, clarifying roles for coalitions and the research teams, and introducing the opioidoverdose reduction continuum of care approach (orcca; a compendium of ebps and ebp strategies; in press, winhusen et al., 2020) . coalition champions within each coalition are identified, who serve as liaisons for implementation in three key areas: orcca menu, collection and understanding of data, and communication campaigns. phase 2 includes an in-depth review of the orcca. ebps are discussed within the context of community need and readiness by engaging coalition members, people at high risk of overdose and their family/friends and local experts from partner organizations. coalitions develop a shared vision for implementing the ebps, consider decision-making processes for selections, and plan for the launch of the communication campaigns. phase 3 involves an iterative process of co-creating a community profile of local resources and a data dashboard to inform community action planning. research staff and/or data champions lead coalitions through a series of workshops and/or training to review, gather, and/or display available data from a landscape analysis (defined above) and other sources in a way that meaningfully guides decisionmaking. the community profile summarizes baseline community data to help identify resources needed to address the opioid crisis. the data dashboard is a web-based platform designed to visualize data related to community goals and the overarching hcs outcomes. in phase 4, each coalition synthesizes data from its community profile to develop an overall community action plan that matches its selected ebp strategies. action plans require coalitions to incorporate insights from phase 3 to reach consensus and prioritize ebp strategies to address vulnerable populations in healthcare, behavioral health, and justice settings and suggest partnerships with emphasis on impact and feasibility. communities set goals, brainstorm, and weigh the benefits of specific ebps and strategies. all research sites are using consensus discussions throughout phase 4 to guide the selection of ebps. the community engagement training protocol for community engagement facilitators includes a module about meeting facilitation and inclusive consensus building that prepares facilitators for these discussions. the action plan includes monitoring and feedback opportunities, and, in some cases, direction for community implementation teams and orcca champions to engage community partners in partner implementation agreements, defining steps and resources needed for a given strategy. in phase 5, research staff and community coalition members meet with partner agencies to develop and support their implementation plans. these plans allow community partners to articulate goals and the resources needed, including technical assistance and funding, to implement the orcca menu selections successfully. monitoring and feedback of implementation activities includes reporting of technical assistance events and ebp selections for specific target populations and venues, and implementation strategies from the compilation by powell (powell et al., 2012; powell et al., 2015) . throughout phase 5, coalitions support community stakeholders' progress, problem solve and suggest further plans as needed with new and existing partners. coalitions may revisit earlier cth phases based on emerging data. phase 6 focuses on sustainability planning and is ongoing throughout the intervention. sustainability activities include: 1) increasing community capacity through hiring and training of j o u r n a l p r e -p r o o f community members; 2) implementing learning health collaboratives to enable local communities and coalitions to learn from each other, share strategies and problem solve; and 3) developing a culture of data-driven decision-making with the use of data dashboards that can be customized and maintained throughout the project and beyond. coalitions receive support to create sustainability plans as they move through each of the phases to ensure cth activities can be maintained when research funding ends. multiple options are available within each menu. in addition to ebps and strategies, each menu includes priority groups at highest risk of overdose and required community settings for implementation. figure 4 provides an overview of the orcca. communities have flexibility in the ebps they select, and selection is based on multifactorial data (e.g., infrastructure and resources, existing services and delivery organizations, gaps in service provision). at least five strategies must be selected for implementation from the three ebp menus: one for overdose education and naloxone distribution, three in different areas that will enhance the care cascade for moud (i.e., linkage to care, initiation of treatment, retention on moud), and one for safer opioid prescribing/dispensing. across the study, if new ebps/strategies emerge (e.g., newly approved medication), they can be added by consensus to the orcca. as the cth intervention seeks to support communities in developing and implementing a community-wide integrated approach, they are also required to implement at least one ebp strategy within each of three required j o u r n a l p r e -p r o o f community settings: 1) healthcare (e.g., emergency medical services, primary care, emergency departments); 2) behavioral health (e.g., substance use treatment programs, mental health treatment centers); and 3) criminal justice (e.g., jails, parole and probation). the hcs research teams developed a technical assistance guide that provides resources (e.g., toolkits, the communication campaigns occur within the phases of the cth intervention (see figure 2 ). communication specialists from the four sites develop materials for the campaigns, including print materials and manuals to guide coalitions in distributing these materials via social media and other channels. extensive message testing is conducted with priority groups to finalize content and images used in print materials. coalitions are also given the option to add other components to their campaigns (e.g., materials for specific groups or social media platforms, use of paid targeted advertising on social media and other outlets). the campaigns are designed to use only locally accessible media resources to avoid spillover effects into wave 2 communities. the use of re-aim as an outcome framework -reach, effectiveness, adoption, implementation, and maintenance (glasgow et al., 2019; glasgow et al., 1999 )offers a means by which the hcs can identify patterns among outcomes that are more generalizable (knudsen et al., this issue) (see figure 5 ). we define reach in the hcs as the number and proportion of individuals who are engaged in the cth intervention, and that is conceptualized as three discrete components described above (i.e., community engagement, the orcca, and the communications campaign). reach also focuses on equity in access to these three components by race/ethnicity, rural/urban geographic status, gender and age. effectiveness encompasses the impacts of the intervention on the primary and other important secondary outcomes (glasgow et al., 2019; glasgow et al., 1999) . adoption, implementation, and maintenance in re-aim shifts attention to the uptake and use of the cth intervention in a community (glasgow et al., 2019; glasgow et al., 1999) . adoption refers to the number and proportion of settings that are willing to initiate use of the intervention. for hcs, adoption is relevant both for coalitions, in terms of the number of j o u r n a l p r e -p r o o f coalitions that are willing to participate in the cth intervention and for the number of settings in communities that are willing to begin delivering ebps from the orcca menu. implementation in re-aim focuses on fidelity to the elements of an intervention. for the hcs, fidelity to the community-engaged activities contained in the cth phases are measured by adherence, quality of delivery, dosage and output. finally, maintenance in re-aim adds a longitudinal design, as it is concerned with assessing the sustained use of an intervention over time and whether the intervention becomes "institutionalized" in routine practice and policy within a given setting. the hcs includes a sustainability phase focused on building the infrastructure necessary to address the ongoing maintenance of the cth intervention and sustainment of the ebps in partner organizations after the research team withdraws. model"provides insight into how internal and external contexts may come to impact implementation processes and subsequently outcomes (feldstein and glasgow, 2008) . integrating constructs from earlier frameworks on implementation and diffusion of innovations (berwick, 2003; green and kreuter, 1999; green et al., 1996; rogers, 2003) , prism's conceptualization of the internal context includes perspectives about the interventions to be implemented as well as the characteristics of those engaged in the intervention. because the hcs is focused on both a community-engaged process with coalitions as well as implementing ebps within the communities, perspectives of coalition members on both elements are likely to impact the re-aim outcomes. implementation success across the re-aim outcomes may be influenced by a coalition's characteristics, including whether they were developed de novo or existed prior to the start of the study as well as the sectors represented in the coalition. constructs j o u r n a l p r e -p r o o f in the prism model are being measured using a mixed methods approach that includes both longitudinal surveys and interviews with coalition members and key stakeholders. the external context will likely play a significant role in the implementation process. key factors in the external context for the hcs include policy and resources at the community, state and national level that may help or hinder efforts to expand the reach of the cth intervention and, more recently, the covid-19 pandemic. further, stigma in the community and in partnering agencies about persons with oud as well as stigma regarding the orcca ebp strategies may pose potent barriers to scaling up these practices over the course of the study. the communications campaigns within the cth intervention are envisioned to mitigate forms of stigma, and thus, increase community support for the orcca ebps and reduce the stigmarelated barriers to accessing these services. the hcs has numerous outcomes tied to hypothesis testing for the primary aim (i.e., reduction of opioid overdose deaths), implementation outcomes (e.g., surveys and interviews on attitudes and access to ebps within communities, agency surveys to assess capacity and barriers), health economics costing of the intervention, and an evaluation of the effectiveness of the communications campaigns. most of these are described in detail in companion papers (e.g., the hcs will conduct health economics research to determine startup and ongoing costs and the overall cost-effectiveness of the cth intervention (aldridge et al., this issue). using an activity-based costing approach, the costs of the core components of the cth intervention are estimated, including time spent in coalition meetings, planning and implementing the communication campaign, facilitating the intervention in communities, and other costs such as staff training and increases in moud dispensed. these cost estimates combine data on the reduced number of opioid overdose deaths attributable to the cth intervention to estimate the cost-effectiveness of the intervention by calculating the additional cost per averted opioid overdose death. simulation models will be developed to evaluate the short-and long-term health and economic impacts of the cth intervention and inform decision-makers about optimal resource allocation to achieve reductions in opioid overdose deaths. 2.8.1 sample size. a total of 67 communities (16 from ky, ma, and ny, and 19 from oh) were randomized to either wave 1 (n=34) or wave 2 (n=33). the hcs as designed has greater than 99% power to detect a 40% reduction (i.e., relative risk of 0.60) in opioid overdose deaths for wave 1 relative to wave 2 communities. however, power remains high even if the intervention effect is smaller than anticipated (e.g., 88% power for a 20% reduction). simulation studies were used to calculate power, accounting for the study design and planned statistical approach. simulation study parameters (i.e., the marginal parameters for the negative binomial regression model and the model's dispersion term which is analogous to the intra-cluster correlation coefficient (icc) (eldridge et al., 2009) ) were estimated based on data obtained from the 67 communities during 2016 and 2017, including community population size j o u r n a l p r e -p r o o f and number of opioid overdose deaths. these estimates were assumed to be the true parameter values for wave 2 communities at the time of the evaluation period. each simulation study was conducted using 20,000 replications to ensure negligible error in calculated powers. a two-sided test with an alpha of 0.05 was used. 2.8.2. randomization. stratified, covariate-constrained randomization (ivers et al., 2012; moulton, 2004) was used to assign communities to either the cth intervention or waitlist comparison arm and stratified by research site (i.e., the state). within sites, covariate-constrained randomization was used to balance arms on three baseline community characteristics: (1) opioid overdose deaths (i.e., rate), (2) population size, and (3) urban/rural status. the following constraints were applied: (1) urban/rural status will be equal for sites with even numbers, otherwise a difference of 1 will be allowed; (2) community population; and (3) opioid death rate will be constrained to <0.2 standard deviation difference. allocation was carried out by the data coordinating center and concealed from all others, including the research sites and the communities. communities were the unit of randomization. once randomization was complete, the resulting community assignments were communicated electronically to the principal investigators at research sites as well as the study sponsors simultaneously. the research site investigators then informed their communities. the communities (clusters) were enrolled by representatives at their respective research sites. random numbers were generated for each site and incorporated into a sas macro (greene, 2017) used to implement the covariate-constrained randomization. all steps in the randomization process were documented and reviewed by an independent statistician for quality control. due to the nature of the cth intervention, the hcs is an open, unblinded study. j o u r n a l p r e -p r o o f 2.8.3 statistical approach. the primary analysis will be based on the intention-to-treat (itt) principle, including all randomized hcs communities according to their assigned group. the primary outcome, number of opioid overdose deaths, and all other secondary count outcomes, will be analyzed using a marginal negative binomial regression model, utilizing smallsample adjusted empirical standard error estimates and degrees of freedom equal to the number of communities minus the number of regression parameters (ford and westgate, 2017; li et al., 2017; mancl and derouen, 2001; sas institute, 2013; westgate, 2013) . the model will include trial arm as the main independent variable and control for the community-level variables included in the stratified, covariate-constrained randomization (i.e., research site, rural/urban status, and baseline opioid overdose death rate) in order to increase statistical power as each of these factors was included in the constrained randomization scheme. the reported natural log of the population size for each community will be utilized as the offset of the regression model, such that the proposed model is a model for the probability of an opioid overdose death in the population. interpretation from the resulting model can be either with respect to changes in the population probabilities (i.e., risk ratios for opioid overdose death for wave 1 vs. wave 2 communities) or in terms of opioid overdose death rates (i.e., rate ratios). reported p-values will be based on two-sided tests at an α=0.05. a sensitivity analysis will be conducted using a permutation test based on the implementation of covariate-constrained randomization. a secondary per-protocol analysis will also be conducted that excludes any community that withdraws early from the hcs and any community that has the intervention halted early based on recommendations from the data safety and monitoring board. j o u r n a l p r e -p r o o f the hcs, a highly complex study in 67 communities across four states, is the largest community-engaged, implementation science addiction research study ever conducted. achieving the study goal to reduce opioid overdose deaths hinges on the engagement of participating communities. each site has an active cab at the state-level to provide guidance on the study design, while local community coalitions serve as the vehicle for implementation. the cth intervention employs a multi-stage, data-driven, community engagement strategy to facilitate the uptake of and access to ebps proven to reduce opioid overdose deaths. community coalitions develop action plans to address the local opioid overdose crisis that include selection of ebps, strategies for implementation, and partner agencies to facilitate implementation. coalitions use data to drive decision-making on the selection and deployment of ebps and to revise response plans as changes occur within the communities. this coalition planning process allows diverse stakeholders, including individuals personally impacted by oud and their family members, to address complex health problems through collaborative decision-making, which increases likelihood of ebp uptake and sustainability. the public health communication campaigns are intended to reduce stigma surrounding the ebps and increase demand for them within the target audiences in the communities (e.g., individuals with oud, healthcare providers). while the 67 hcs communities are heterogenous in many characteristics, all are located in medicaid expansion states, so it is unknown whether the impacts of the cth would generalize to communities in non-expansion states. the hcs study was launched prior to the onset of the covid-19 pandemic. mitigation efforts have affected many aspects of the study (e.g., stay-at-home orders have impacted the provision of oud treatment, the capacity of communities to respond to covid-19 while j o u r n a l p r e -p r o o f participating in the study, and the ability to have in-person meetings with communities and key stakeholders). research sites and communities are adapting to meet these challenges. most notably, community coalition planning and stakeholder meetings switched to web-based formats. while the early advent of this current opioid crisis impacted primarily white communities, more recent data show dramatic increases in rates of opioid overdose deaths in minority populations, especially in black individuals, with an alarming increase attributable to synthetic opioids (drake et al., 2020) . these epidemiological findings coupled with ongoing lack of equitable access to treatment for oud (e.g., lagisetty et al., 2019) highlight the importance of addressing these inequities to ensure equal access to ebps for treating oud and reducing opioid overdose in the hcs. the hcs design and execution are envisioned to ensure inclusivity and diversity in planning and community engagement and to ensure that diverse and marginalized populations are reached with the intervention. with regard to planning and community engagement, there are intentional efforts to ensure cabs and community coalitions include diverse representatation with attention to race, ethnicity, gender, sexual orientation and ensuring participation of those in recovery. with regard to reach of the intervention, communities are actively targeting marginalized populations for intervention often through careful selection of sites or agency partnerships providing services to those populations (e.g., criminal justice populations, homeless, etc.). hcs data analyses will directly evaluate the impact of various demographics, including race and ethnicity, and other social determinants of health on study outcomes. community facing hcs materials are developed to reflect different racial and ethnic groups, including, for example, the communication campaign advertisements, while study tools, such as overdose education training materials, are developed in multiple languages. the cth intervention with its strong community engagement, diverse stakeholders, and data-driven j o u r n a l p r e -p r o o f decision-making provides a way to document and address racial and ethnic inequities in access to ebps. the hcs will collect a rich data set to understand uptake and sustainability of the cth including cost and cost-effectiveness. this will be accomplished within an established implementation science framework that will identify barriers and opportunities (examining both internal and external context) and engage community agencies to enhance delivery of ebps, expand agency access to resources, facilitate change in policy to enhance availability of ebps as needed, and understand how community characteristics (e.g., rural/urban, community-specific social determinants of health) underlie effective uptake of, fidelity to, and sustainability of the cth intervention. if effective, the cth intervention will provide a generalizable intervention that can be applied in other communities to prevent opioid overdose fatalities and related consequences. this research was supported by the national institutes of health through the nih heal initiative under award numbers um1da049394, um1da049406, um1da049412, um1da049415, um1da049417. the content is solely the responsibility of the authors and does not necessarily represent the official views of the national institutes of health or its nih heal initiative. all authors contributed to the development of the hcs measures, the development of the framework for the manuscript, and the editing of the manuscript. s. slavova, j. villani, and s.l. member of a scientific advisory board for alkermes, novartis and us worldmeds. kk has been compensated for providing consultation and reports for ongoing opioid litigation. slw serves as a scientific advisor to opiant and has served as a scientific consultant to otsuka, brainsway therapeutics, astra zeneca and biosciences summit. all other authors have no conflicts to declare. 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engagement, community organization, and community building opioid overdose rates and implementation of overdose education and nasal naloxone distribution in massachusetts: interrupted time series analysis on small-sample inference in group randomized trials with binary outcomes and cluster-level covariates developing an opioid use disorder treatment cascade: a review of quality measures press. the opioid-overdose reduction continuum of care approach (orcca): evidencebased practices in the healing communities study. drug and alcohol dependence treatment utilization among persons with opioid use disorder in the united states state naloxone access laws are associated with an increase in the number of naloxone prescriptions dispensed in retail pharmacies dr. larochelle reports receiving consulting funds for research paid to his institution by optumlabs, outside the submitted work. the authors have no competing interests to declare. key: cord-259672-qdrcb2ce authors: brown, nancy a.; rovins, jane e.; feldmann-jensen, shirley; orchiston, caroline; johnston, david title: exploring disaster resilience within the hotel sector: a systematic review of literature date: 2017-02-06 journal: int j disaster risk reduct doi: 10.1016/j.ijdrr.2017.02.005 sha: doc_id: 259672 cord_uid: qdrcb2ce within the tourism industry, the hotel sector's vulnerabilities are multi-faceted. this literature discussion scrutinizes how disaster and resilience is framed for the tourism sector, and, more specifically, how the concepts can be applied to the hotel sector. a synthesis of the literature points to the importance of prioritizing disaster resilience building for the hotel sector. the body of literature regarding disasters, tourism, and more specifically hotels, has increased over the last 20 years, still improvements in the hotel sector's disaster preparedness and do not appear to be on the same trajectory. illustrating the predicament of the contemporary hotel industry serves to open a discussion about the value of building resiliency to disaster for hotels. as the numbers of people affected by disasters grows, the importance of providing actionable information to limit the severity of these events on communities also escalates in pace. an important aspect of the world's increasing interconnectedness is the ease and frequency of travel. increased numbers of tourists traveling to places of varying risk has exposed new and uncertain vulnerabilities to the tourism sector [79] . tourism is vulnerable to disaster because it relies upon infrastructure, the ability to move around freely, and people's perceptions of safety [62] . within the tourism industry, the hotel sector's vulnerabilities are multi-faceted. a hotel's physical infrastructure (buildings, water, power, sanitation) may be at risk from a variety of natural and manmade hazards placing staff and guests at risk. beyond guest and staff safety, a hotel's ability to continue operations and profitability is often at risk in disasters. the hotel's surrounding environment (sea, forests, natural beauty) can be affected by hazards making their locale less desirable for future tourist in the short term [5] . hotel vulnerabilities are complex and factors that contribute to risk are often the tourist motivation to visit. disastrous events can influence tourist's choices of destinations [24] . management of destination image, disruption from extreme weather, and event impacts causing slow recovery may all affect tourism destinations negatively [94] . examples of this influence can be seen in: the 2001 foot and mouth disease outbreak, which is estimated to have cost the united kingdom tourist industry between usd$3.3 billion and usd$4.2 billion due to decreased numbers of tourist traveling to the countryside [93] ; the 2003 severe acute respiratory syndrome (sars) epidemic which coincided with japanese outbound tourism dropping as much as 55% in one month [15] ; and hurricane katrina's impacts on new orleans which resulted in 1409 tourism and hospitality businesses shutting down-affecting 33,000 hospitality employees, a decrease of usd$15.2 million per day in business and leisure travel expenditures [72] . these examples highlight how disastrous events can affect tourism. people's perceptions can be negatively influenced by media coverage of an event [19, 24, 54, 72] . in the aftermath of the 2004 boxing day tsunami, the hotel industry in phuket, thailand successfully reopened 80% of their hotels within a week, only to see occupancy rates drop to 10% [29] . decrease in tourism can also be due to facility availability and access. in 2005, following hurricane katrina and the new orleans levees failure, the lodging industry in new orleans, which included an estimated 38,000 rooms, was almost completely shut down [91] . following a second major earthquake in five months (february 2011) christchurch, new zealand lost two-thirds of their hotel inventory [64] . increasing interdependence of the tourist industry, where a negative event in one location can affect the tourist economy of many countries [43] . for example, the 2010 icelandic volcanic ash cloud caused disruption to air travel throughout europe [66] . "tourism destinations in every corner of the globe face the virtual certainty of experiencing a disaster of one form or another at some point in their history" ( [24] , p. 135). illustrating the predicament of the contemporary hotel industry serves to open a discussion about defining disaster resiliency for hotels. a cross-disciplinary lens may provide an opportunity to identify connections between the hotel sector's needs (ensuring safety and security of guests and staff as well as remaining operational and profitable) and disaster resilience building. the purpose of this article is to examine the literature and explore important disaster resilience and hospitality industry concepts that can be applied specifically to the hotel industry. defining key terms including disaster and resiliency within a hotel context begins with an examination of the literature. these definitions form the basis for discussion of both disaster effects on hotels and disaster resilience building within the hotel sector. the review synthesizes current concepts of disaster resilience building in the context of the hotel sector, and extracts concepts to inform further development in building disaster resilience into the hotel sector. search word of disaster and hotel provided 143 peer reviewed articles, after duplicates and articles not on topic were eliminated. additional articles and grey literature were captured through reviews of selected articles reference lists. in total 352 articles and papers were identified and thematically coded for this literature review. in order to discuss disaster resiliency, as it applies to the hotel sector, it is important to first explore the literature aimed at defining these terms. the objective is to synthesize common definitions for disaster and resilience as they will apply to this discussion. the concepts of disaster and crisis, as applied to tourism businesses, have been examined by many scholars [1, 17, 24, 58, 79] . rockett [84] writes that definitions may be transient over time, but can serve our current need and allow for common understanding. the most prevalent definitions adopted by authors of tourism sector research has been faulkner's [24] concept that crises often have a component that could have been controlled by the group being affected (e.g. management failing to react to events in a way that minimizes effects), while disasters occur suddenly and the actual trigger event is out of the control of those affected (e.g. an earthquake hitting a populated area). ritchie [80] recognises that an overlap can occur, when leadership actions during a disaster then develop into a related crisis, thus confusing the concepts. some authors chose not to tackle the distinction of disaster and crisis but instead use the terms alternately or simultaneously [80] . [56] describes disasters as events that are the result of interaction with the physical environment, the social and demographic characteristics of the community within the physical environment, and the built environment the community constructed. disasters are often predictable, and in some cases avoidable [56] . while many disastrous events are not controllable by human societies, affects may be minimized through action. disasters are often described as a cycle with phases leading from one to the next. a common cycle is the 4 r's; reduction, readiness, response, and recovery [55] . in this spectrum one reduces (or eliminates) possible risks, readies for risk that cannot be reduced or eliminated, responds to events with the readied preparation, and works toward recovery after the event, including reducing or eliminating possible threats. faulkner [24] provides six phases of disaster in a tourism disaster management framework. these phases include: 1) pre-event, where action is taken to reduce effects of, or eliminate, potential events; 2) prodromal, the time immediate prior to an imminent disaster where warnings and plans are initiated; 3) emergency, the actual disaster response activities; 4) intermediate, where short term issues are resolved and return to normal is being planned; 5) long-term recovery, a continuation of previous phase; and 6) resolution, the final phase where normal activities resume and review of events takes place. in both of these disaster management cycles the concept remains that the management process begins prior to the onset of an event with planning and risk reduction, continuing through to learning lessons and applying those lessons to future planning. a key concept in the discussion of disaster is that disasters are social disruptions [85] . the disruption to human society causes the event to be termed a disaster-even though a physical event such as an earthquake may begin the cycle. for example, a magnitude 6.5 earthquake that occurs in an undeveloped and unpopulated part of the world is of little consequence. the same earthquake in a developed area has the potential to cause severe disruption and may be termed a disaster. the term disaster can also illustrate a lack of capacity to manage an event. as a description of the resources needed to stabilize the event, a disaster requires recruitment of resources from outside of the affected community [97] & caribbean alliance for sustainable tourism cast [96] . examining an event in terms of resources required to respond illustrates that disruption to human systems is integral to defining a disaster. a small hotel with limited resources could experience a disaster that a larger hotel with greater resources might have been able to handle internally with minimal disturbance. for the purposes of this discussion, the definition proposed by faulkner [24] will form the basis for defining disaster with additional wording taken from [56] , and rodriguez, quarantelli, and dynes [85] . for the remainder of this discussion disaster is defined as: a sudden event where the trigger is outside the current control of the affected area (community and/or business), the event disrupts the function of that area and requires additional resources (other than those available within the area) to respond to and recover from the event. the concept of resilience has been explored over many decades among a range of disciplines, including ecology, engineering, psychology, and social science [22, 27, 3, 36, 40, 47, 48, 58] . it is worth highlighting that the meaning of resilience, at its heart, remains similar across disciplines, but the nuances and values vary based on application. the root resiliere comes from the latin 'to jump back'; however, in the context of disasters affecting societies this definition falls short, as it may not be possible to go "back" to the state prior to the disaster [67] . going back to the previous state may also be undesirable, if it means building back to the same vulnerabilities [23] . resilience is a dynamic condition. many scholars have worked toward finding a shared meaning of resilience. however, in order to study resilience one must first define: resilience by whom; and resilience to what [17, 47, 7] . a universal understanding of resilience is not possible: without frameworks tailored to specific populations, levels of analysis, phase of disaster, and even the unique disaster context, our ability to advance the science of disaster response toward more resilient communities is limited ( [60] , p. 233). for each group, and each circumstance, the meaning of resilience can take on new dimensions. exploring some of the different ways resilience has been applied can be a constructive process toward defining disaster resilience for hotels. resilience definitions vary based on the context. the following discussion explores literature concerned with resilience within the context of systems, organisations, economics, and communities in an effort to understand how resilience may apply to the nexus of disasters and hotels. resilience concepts for systems have undergone numerous interdisciplinary scholarly reviews [14, 17, 2, 39, 58, 61, 70] . further insights are gained from research in physics, mathematics, psychology, and psychiatry, and ecology by aldunce et al. [2] , whose work showed that resilience is not just bouncing back to the previous state, instead resilient systems have the capacity to change and adapt to new stresses, and create a new norm from which to continue forward. resilience in complex adaptive systems (cas) differs from engineerbased systems resilience. engineer-based systems resilience looks at returning to previous state of functionality [87] . cas theory considers a move to a new normal that allows functioning to continue. four characteristics that help a cas to be resilient include: "…capacity for creative innovation, flexibility in relationships between the parts (of the system) and the whole, interactive exchange between the system and its environment, and a crucial role for information in evolving complexity" ( [12] , pp. 159-160). a cas can also vary in size and components, moving, expanding and contracting as needed. in the case of hotels, groups of internal departments working together can function as a cas, and those same groups working with external partners can also be a cas. those same groups unable to be innovative, flexible, and collaborate in the face of disaster can delay response and recovery. the ability of a system to adapt and change is critical in our understanding of resilience as applied to larger groups, including business organisations like hotels. tourist destinations can be conceptualized as "… a human-environment system" ( [5] , p. 956). during an unfolding disaster a hotel's management and staff must understand the possible risks to the business, guests, and surrounding area, and have the capacity to cope with those possibilities exists. organisational resilience considers physical properties as well as organisational structure and capacities [17] . resilient organisations are able to overcome adversity and continue forward, often thriving as they reinvent themselves [18] . building organisational resilience includes "…reducing the consequences of failure and assuring business/service continuity under adverse conditions" ( [87] , p. 79). in studies of resilient organisations, a few common traits have been proposed. resilient organisations question assumptions about their environment constantly and are competitive [40] . da.hles and susilowati [18] write there are three components to a business's resilience: survival, adaptation, and innovation-all working together to make an organisation resilient. for hotels, these actions translate into understanding changing risks in a variety of contexts, and working to limit those risks constantly. resilient organisations employ adaptive strategies in a rapidly changing environment; the adaptations may fundamentally change the organisation in some ways, but allow it to survive into the future [18] . organisational structure and culture influence adaptive capacities [102] . as an example, comfort [12] , in her study of the 1994 northridge earthquake response, found the response's networked organisational structure and flexible leadership allowed for higher functioning and quicker decision making. when organisations are too rigid and systematic, with too many layers of bureaucracy, they are less able to create adaptation strategies during dynamic events [12, 8] . sawalha [88] studied resilience of insurance companies in jordan. findings included that the jordanian business model characterised by centralized power and hierarchy, with low levels of autonomy and delegation worked at cross-purpose with resiliency. organisational structure, adaptability, culture, and flexibility features may all influence hotel disaster resilience. large hotel chains may have organisational hierarchies that make quick decision-making, flexibility, and adaptive strategizing difficult. despite the fact that organisations rarely prioritize resilience building, a. v. lee et al. [40] argue that many traits of a resilient organisation are also traits of successful organisations. obstacles to building resilience in organisations include a lack of tangible ideas and concepts for businesses to adopt or adapt for their organisation [52] . these challenges have slowed progress in building resilient organisations. it may be possible to overcome some of these impediments by focusing on the intersection of resilient organisations and successful organisations. resilient organisations have improved response to more common daily challenges because they have an increased self-awareness, greater ability to manage their vulnerabilities, and are adaptive and innovative [2] . capitalizing on this idea a hotel may be able to build success commercially while building disaster resilience. in making a case for organisational resilience building, a. v. lee et al. [40] proposes adaptive capacity building and pre-planning as components to becoming increasingly resilient to disaster. paton and hill [68] also suggest the ability of an organisation to adapt and change predicts a business's ability to survive post disaster. organisations need to integrate elements of resilience into their daily philosophy to improve response in the face of adversity [88] . integrating resilience management into everyday business practices through "encouraging increased situation awareness, improved adaptive capacity, and better identification and management of keystone vulnerabilities" is also important ( [52] , p. 84). thus, the research points to the importance of organisation's adaptive capacity in building resilience. economic resilience is another element of disaster resilience building within the hotel sector. economic resilience is defined as the "… ability or capacity of a system to absorb or cushion itself against damage or loss" ( [86] , p. 228). hotels are fundamentally businesses that must maintain financial viability to continue operations. there are two distinct areas of business resilience: the customer considerations and the supply considerations [87] . customer-side resilience takes into account disruptions in customer's service, while supply side looks at service disruptions in supply chains. both of these areas are important to disaster resilience for hotels. additionally economic resilience can be broken into two separate measures: static economic resilience concerns the ongoing ability of an organisation to function; and dynamic economic resilience refers to the flexible capacity of organisations to reorganize and stabilize quickly. an important economic resiliency implication is that local tourism businesses are critical to the wider community economy in terms of providing jobs and customers for other businesses [18] . additionally, hotels that can remain operational in the aftermath of a hazard event often maintain strong occupancy through services provided to response and recovery teams [21, 25, 75, 83] . the individual business resilience is at micro level of an economy. the industry's resilience (e.g. tourism) is at the meso-economic level, and the community's resilience is the macro-economic level [87] . accordingly, organisational resilience is linked and connected to community economic resilience. community resilience to disaster is the ability of a group to mitigate and withstand the effects of disaster, however, there is little consensus regarding the components and processes that enable communities to be disaster resilient [9, 69] . write that a community's disaster resilience is built on, "… efficacy, problem-focused coping, and a sense of commu-nity…" community resilience has also been defined as "…a process linking a network of adaptive capacities (resources with dynamic attributes) to adaptation after a disturbance…"( [58] , p. 127). these characteristics are identified as: 1) economic development -equitable distribution of economic resources within a group; 2) social capitalrelationships as resources; 3) information and communication -creating common meaning and understandings and systems to move information in times of stress; and 4) community competence -the ability to make decisions and take actions as a collective. these diverse facets point to the complexity of community resilience. organisations and communities are inextricably linked [52] . resilient businesses assist a community in maintaining social continuity in the aftermath of disaster [57] . resilient organisations improve the ability of communities to respond to disasters [40, 52, 88] . looking at community resilience as a basis for developing a model for building resilience in the tourism sector, bec et al. [3] use a definition of community resilience that included a group's ability to harness resources to adapt to change [7] . reviews definitions of community resilience and finds "…they refer to "community" as a large social group…" while an imminent and potentially disastrous event can pose incredible challenges for a hotel operation, disaster preparedness and resilience building can mitigate the consequences [39] . a hotel is an integral part of its larger community, but may also its own community. building resilience requires participation by all stakeholders, across sectors. disasters happen to all members of a community at the same time, and recovery must happen together as well [58] . building communities that are resource and capacity rich, and helping them understand risk is at the heart of resilience building. furthermore, planning ways to overcome potential hazards allows communities to take advantage of, and enhance, those qualities and capacities already available to their communities. the sheer number of components that combine to form a community makes assessing dimensions and indicators for community resilience more difficult [17] . discuss the "multifaceted nature of resilience", which poses challenges in designing assessment to manage the disaster resilience building process. furthermore, conditions of resilience are dynamic, not static, so evaluation of components and measures is required on a consistent basis [71] . however, resilience in communities can be enhanced through preparedness planning, risk awareness, and communication [17, 37, 70] . hotels, seen through the community resilience lens, are multifaceted groups and need dynamic and collaborative analysis, preparedness, and communication ideas for handling potential disasters. based on a composite of ideas presented in this discussion the definition of hotel resilience to disaster in the context of this discussion will be: a dynamic condition describing the capacity of a hotel, together with its stakeholders, to assess, innovate, adapt, and overcome possible disruptions that may be triggered by disaster. resilience and vulnerability are often linked in research; however, they are not opposite ends of the same spectrum [17, 7] . it is possible to be vulnerable in some ways, and resilient in others. vulnerability to disaster describes the extent to which a person, community, organisation, or system is susceptible to negative effects from a hazard [5] . understanding vulnerabilities to disaster is an integral part of assessing capacities to overcome potential disastrous situations and implementing risk reduction measures. one danger in equating resilience to vulnerability is the resultant circular thinking, "a system is vulnerable because it is not resilient; it is not resilient because it is vulnerable" ( [36] , p. 40). both terms are defined by the specifics (who, when, and what) of the situation [7] . for example, elderly people are often considered a vulnerable population, however in some situations they prove to be resilient due to their array of experiences to draw from and reduced expectations that the government will come to their rescue [74] . circumstances can alter resilience and vulnerability of people and groups and requires careful assessment. vulnerability is a condition that is evaluated in a pre-disaster setting, resilience is evaluated by post-disaster outcomes [86] . understanding vulnerabilities that exist in a community is fundamental to building resilience in a community, and ultimately steps to mitigate those vulnerabilities must be taken to build resilience [34] . enhancing adaptive capacities in tourism destinations can decrease certain vulnerabilities and build resilience [76] . "…the concepts of vulnerability, adaptive capacity and resilience are linked: enterprises that are less vulnerable and have more adaptive capacity are likely to be more 'resilient'." ( [6] , p. 649). reducing vulnerabilities and embracing sustainable practices are critical to developing disaster resilience [17] . hotel's evaluation of their vulnerabilities can improve their adaptive capacities and build disaster resilience. the sendai framework for disaster risk reduction 2015-2030 (sfdrr) highlights that disaster continues to hamper efforts to improve sustainability in many economies (united nations office for disaster risk reduction [98, 99] . the new framework reiterates the essential need of public and private enterprise, and refocuses efforts upon reducing disaster risk and building resilience at all levels. specifically the framework challenges the tourism industry to "promote and integrate disaster risk management approaches…given the …heavy reliance on tourism" in many parts of the world ( [98, 99] , p. 20). sawalha, jraisat, and al-qudah [89] writes that hotels in jordan are less likely to allocate resources to activities that do not show an ability to generate profits short term. short-term thinking can result in response-oriented approach to disaster management. building disaster resilience for the hotel sector is works in tandem to the objectives and goals of the sfdrr. sustainable tourism considers what tourism, as a part of a bigger system, works toward sustaining, rather than how to sustain tourism activities (s [51] .). in a hotel, actions taken in the course of business that are unsustainable may ultimately make the operation of the business unstainable too. for example, a hotel that does not account for the health of the local reef in planning tourist activities may damage and degrade the reef making their facility less desirable to snorkelers and reef enthusiasts. "one way to reduce the susceptibility of communities to loss from hazard consequence is to create a community that is sustainable and resilient" ( [32] , p. 40). a disaster resilient community contributes to that community's sustainability [36] . resilience and sustainability may use different avenues and methodologies but they work toward the same goals [42, 78] . to achieve sustainability a community should "maintain and, if possible, enhance environmental quality" ( [90] , p. 79). sustainability can be natural resource centric, but the objective is continued function with no depreciation of quality of life [49] . a shift that emphasizes sustainable practices may ultimately be good for hotels business in the long term. while there exists much common ground between sustainability and resiliency, redman [78] suggests that some objectives may be in conflict and the study of these two subjects should remain independent. this opposing view considers that the adaptive cycle of resilient systems may adopt a new norm that is not sustainable long term, in order to continue functioning in the short term. when building resilience to disasters short-term, non-sustainable adaptions are often critical for survival and a part of the process. for example, in a hotel context consider adaptions like petrol powered generators to maintain minimum critical functionality, while this is a non-sustainable solution it is also often a short-term solution required to maintain operations. the body of literature regarding disasters, tourism, and more specifically hotels, has increased over the last 20 years, yet improvements in the hotel sector's disaster preparedness have not kept pace. ritchie [81] outlines the need of all tourism organisations to assess their vulnerabilities and risks, placing increasing emphasis on planning and prevention, as opposed to the more common focus on response and recovery strategies. there is a need for businesses to consider how they are creating and/or enhancing risks and act to minimize these effects (united nations economic and social commission for asia and the pacific escap [95] s.awalha et al. [89] studied five star jordanian hotels and found that disaster management was considered a response and recovery activity, as opposed to a proactive management of variables to decrease the possibilities and severities of risks. faulkner [24] brings to light that few tourism organisations recognize the importance of risk reduction, planning and preparedness. a history spanning decades of incidents and accidents in the hospitality industry was published in the cornell hotel and restaurant administrative quarterly [16] . the account included many well-publicized disasters such as the 1980 las vegas fire in the mgm hotel and the 1982 eruption of mount saint helens (tourism effects on the pacific northwest). this 1985 journal editorial explained that the hospitality industry was learning from each of these events, and hotels (as well as restaurants) were reducing their disaster risk with each event. a disagreement is evident in the literature regarding improved disaster management. some literature reflects that hotels are reviewing past incidents and attempting to learn lessons [16] , and other literature contradicts this assertion [20] . procedures and plans for handling disasters were found to be nonexistent in a 1997 survey conducted by drabek, where 827 hotel guest who had experienced disastrous circumstances participated [20] . kwortnik [38] argues that the industry seems to be repeating the same mistakes repeatedly, based on a study of some hotel's reactions to the 2003 blackout in the eastern united states. chien and law's [10] article discussed the hotel industry's widespread concern of the spread of sars, and the lack of guidance for hotels on epidemic topics. during the 2003 sars, hong kong experienced an 80% decrease in tourism as a result of this epidemic [10] . these examples highlight that implementing lessons learned in disaster preparedness for the hotel industry may be low priority. preparedness planning helps to ensure resources needed for response and recovery are available, by deciding in advance who will do what, when, and where in different circumstances (united nations environmental programme unep [97] . complete preparedness planning for disasters can also reduce risk [73, 80] . writes, "…taking a more strategic or holistic approach to disaster planning and preparation may reduce the likelihood of linked events, 'escalation' or the 'ripple effect' occurring due to the chaotic and complex inter-relationships within an open tourism system." furthermore, preparedness planning for disasters by the tourism industry should be integrated and viewed as essential in a world where growing numbers of disasters are impacting tourism [81] . the uncertainty of hazards complicates the ability to develop detailed preparedness plans [80] . even though control over natural forces is rarely possible, the effects of these events on communities can be mitigated and diminished through preparedness efforts. "…surprise is an inevitable event whose magnitude and rippling consequences can be anticipated through knowledge, emerging tools, consensual social collaboration, and preparations to be flexibly innovative" ( [13] , p. 273). in recent years, building disaster resilience in organisations and communities has been studied as one way to combat the unpredictability of disasters. disaster related research for the tourism industry tends to be response and recovery centric, with less attention paid to the preparedness and preventative possibilities [10,24,31,39,4,50,79,102 ]. the academic discourse on crises and disasters in the tourism sector is often reactive in its approach. hall [28] reviewed the literature concerning economic and financial tourism crises between 1977-2010 and found surges in literature following events like oil shortages and the 2001 attack on the world trade center in new york. combating the response centric focus, some authors have worked to develop frameworks that describe pre-disaster emergency response planning and postdisaster activities. frameworks, models, and planning techniques have been explored and developed for the tourism industry, and to a lesser extent hotels ( [24, 31, 45, 5, 50, 65, 77, 79, 92, 102] . the tourism industry is encouraged though the growing literature to take action to improve their ability to survive and even thrive in the aftermath of a disaster. in practice, however, a response focused attitude toward disasters seems to continue to be prevalent in the tourism sector. the recent hotel resilient programme provides guidance to strengthen disaster resilience for the hotel sector through design and promotion of a certification programme [100] . the certification is focused on larger properties, with a more guidance-oriented approach for smaller hotels. the programme, sponsored by the unisdr, gidrm, and pata aims to build resilience to disaster though encouraging disaster risk reduction strategies in three categories, with 18 subcategories [35] . these categories include building location, design and structural elements, systems design to warn and minimize risk, (e.g. fire protection and evacuation systems), and management risk reduction planning components, which include training, drills, communications planning, and continuity planning. the hotel resilient programme is currently piloting in indonesia, the maldives, myanmar, the philippines, and thailand [101] . a scoping study, of interviews with 17 hotel and tourism professionals, explains that a hotel's disaster risk and resilience is not currently a priority for guests; however, guest's general interest in safety is increasing. the existing barriers to the programme were consistent with the literature; interviewees identified cost, time, and capacity as potential obstacles to engaging in a certification programme [101] . this programme offers a great step forward for hotels; however, focus is on disaster risk reduction strategies (e.g. infrastructure, warning, and risk reduction planning). while disaster risk reduction is a component of disaster resilience, this initiative does not seek to address other possible components of organisational resilience. these include organisational structure and flexibility [102, 18] , adaptive capacity [40, 102] , and less tangible resources such as social capital [37] . qualities such as sense of community and self-efficacy improve resiliency [26, 37] , and may be more influenced by organisational culture than disaster risk reduction strategies. unfortunately, the hotel resilient programme does not delve into these subjects. building preparedness and resilience to disasters in the tourism sector lacks significant progress [31, 45] . for example, in 2006, hystad and keller [31] did a follow-up study, three years after a major forest fire affected tourism businesses near kelowna, british columbia, canada. in the original study, 104 tourism businesses were surveyed regarding their preparedness for disaster. the original 2003 study concluded the businesses were not prepared for a forest fire, although an occurrence of an event like this fire was highly probable [30] . the 2006 follow-up study identified 38% (up from the previous study showing 26%) of those businesses in their study had a disaster management plan. further analysis of the data revealed that the majority of those businesses had only informal planning. the study's conclusion was that tourism businesses lack the will to improve and develop their own contingency planning ( [31] , p. 157). hotel staffs, along with the organisations, are unprepared to face disasters that may affect hotels. staff members were found to be lacking information on disaster practices and hotels failed to carefully assess their risks [102] . mahon, becken, and rennie [44] suggest tourism employees may not have confidence that their employer's plans are sufficient to be effective in the face of disaster. the inclusion of stakeholders, including staff, in disaster management activities is important for the success of preparedness planning and emergency response. disaster planning undertaken by accommodations managers in australia was reported to be at 74.9% in a study by ritchie, bentley, koruth, and wang [81] . however, the authors recognize the study, while positive trend in increased disaster planning, relied on selfreporting by accommodations managers and did not detail the extent to which the planning had been done. the reactive, rather than proactive, management of disasters and that plans were not necessarily embedded in their organisation was a point [63] research highlighted. hotels in new orleans, post-hurricane gustav, were closed for up to 7 days, with the median being 3 days [39] . full service, food and housekeeping, was not restored for 6-12 days following the hurricane (only 6% reported loss of power as reason for delay). lack of staff to run the operation was found to be the primary cause. lamanna et al. [39] examined new orleans hotels' response to hurricane gustav in 2008. the study showed that while 80% indicated they had a written plan for hurricane evacuation, only 54% involved their staff in the process and 58% had procedures for training staff. 46% provided an annual exercise for the staff to participate. new orleans hotels have capitalized on lessons learned from previous hurricanes, yet they still have much room for growth and improved resilience. based on these reviews it is clear that tourist organisations, including hotels, are not proactively assessing, and planning, to minimize their risk to disaster. communities must consider carefully the role they play in creating some of the billion dollar losses attributed to disasters [56] . this idea, viewed through a tourism lens, serves to illustrate that hotels may play a role in creating their risk. high-risk locations and attraction of guest unfamiliar with the area combined with inattention to staff training and preparedness planning can be an expansive and lethal combination. the accommodation sector is vulnerable to disaster based on its 24/7 model and sensitivity to external factors [82] . hotels are often located in highrisk locations based on guest preference to vacation in coastal or alpine environments [53, 62, 81] . as an industry, the tourism sector has been found to avoid openly discussing hazards of any sort [11] . the marketing literature of hotels is designed to entice guests, thus chooses to minimize any risk potential while highlighting local activities and positive features. tourist can be particularly vulnerable in a disaster due to their lack of familiarity with the region, customs, hazards, and local language [33, 39, 46, 53, 59] . this lack of familiarity and knowledge can inhibit their ability to take protective actions. it has been argued that lack of community and business preparedness, and official tsunami warnings exacerbated the effects of the 2004 indian ocean tsunami [45] . guests and locals alike simply did not recognize the immediate danger (as the water receded unexpectedly) and the critical need to head to higher ground. beyond commercial enterprise, caring for communities, environments, or assist in social development is an organisations responsibility, often termed corporate social responsibility [29, 41] . in addition to the above responsibilities, henderson expands on this concept, stating that visitors to an area need to be supported and oriented to their new environment. hotels have a corporate social responsibility to have plans to care for, and keep safe, their staff and guests [29] . a study of hotels in thailand, following the 2004 boxing day tsunami, looks further into corporate social responsibility. common traits of socially responsible organisations included, "…investment and involvement in social welfare… compliance with official regulations and a willingness to exceed these…education and engagement of customers and staff about social and environmental issues of concern ([29], p. 232). the hotel sector's responsibility must include placing high value on ensuring the safety of their staff and guests, while also improving their organisation's ability to come through disastrous events and continue to be operational and profitable [29] . hotels have a responsibility to understand their risk and vulnerabilities-and create strategies to prevent or mitigate events stemming from predictable disasters [44] . the expansion of the tourism industry gives rise to the need for disaster preparedness and investigation of ways to return to operative capacity [97, 96] ). disaster resilience building can decrease effects of events, improve life safety, and get hotels back to operational status. the hotel sector's around the clock, 365 day a year model elevates the importance of disaster resiliency. guests will always be present, as will staff. disaster resiliency for hotels may translate into lives saved, as well as business reputation. however, the idea that disaster preparedness plans, disaster risk reduction activities, and disaster resilience building are separate activities from commercial concerns is reflected in the literature. an example of this disconnect may include managing a profitable hotel business; yet, managers do not prioritize planning for continued operations following a disaster. competition for support and funds can be difficult as preparedness planning and resilience building are hard to quantify in regards to return on time and investment [40, 52] . furthermore, tourism operators may not be making headway due to the already voluminous workload, leaving little time to pursue new planning avenues [63] . promoting benefits to building disaster resilience that also work toward improved profitability and functionality may improve the buyin from management. one study of hotel stock prices indicated socially responsible actions can improve a hotel company's short and long term profitability [41] . illuminating the value of building resilience-for both day to day operations and in times of disaster may also promote a greater understanding of what a resilient organisation truly looks like [52] . "…elements of resilience and competitive excellence share many of the same features…", for example, organisations with these characteristics constantly scan for and interpret changes or risks in the environment and develop adaptations as needed [40] ., p. 31). disaster resilience building may be a tandem feature of competitive business practice. the academic literature on resilient organisations suggests that business continuity plans are essential and should provide a range of functions: 1) management and information systems to continue as needed for core business functions; 2) management's ability to transition from routine to crisis mode; and 3) preparedness plans that are designed to ensure operating capacity and capability even under extreme conditions created by a disaster ( [68] , p. 251). business continuity planning is focused on establishing a strategic plan to reestablish key business operations to ensure business survival [57] . business continuity planning may include such things as audits of facilities, identifying key persons, developing prevention strategies, and acquiring insurance to cover potential losses [57] . in addition, preparedness planning for organisations must include how to operate in unusual conditions, such as lack of water or power. resilient enterprises analyse disruptions to find positive actions that will carry the business forward. the ability to plan for and manage disastrous situations ought to be integral to management training for tourism professionals [102] . disaster planning may be integrated into a business's strategic management and planning as the two concepts share the objective of long term survival of an organisation [102] . strategic plans allow for quicker reaction. lack of planning can result in slow decision-making and slow action plan formulation following an incident. delays can exacerbate the impact. at the same time planning can be challenged by the chaotic nature of an unfolding disaster [79] . there is an overlap between business continuity planning, strategic management, and resilience building. however, building resilience also considers flexibility, social capital, and innovation in ways that business continuity planning and strategic management may not. clearly if managers are building disaster resilience in their continuity and/or strategic planning, an opportunity to shift the paradigm toward improved disaster resilience exists. tourism's essential and integral ties to the community require a level of responsibility to maintain operative capacity [29] . the ability for a business within a community to continue to operate during a disaster is foundational to the overarching recovery of the wider community [52] . a synthesis of the literature points to the importance of prioritizing disaster resilience building for the hotel sector. as the numbers of tourists affected by disasters grows, the importance of providing actionable information to limit the severity of these events on communities, including hotels, also escalates in pace. the literature discussion above scrutinizes how disaster and resilience are framed for the tourism sector, and how these concepts apply to the hotel sector. resilience to disasters for the hotel sector is a dynamic condition describing the capacity of the organisation, together with its stakeholders, to assess, innovate, adapt, and overcome possible disruptions triggered by disaster. integrated into building disaster resilience for hotels is disaster risk reduction activities (including structural and nonstructural analysis that looks at operational and service factors from an all hazards perspective), and preparedness. sustainability of hotel policies and actions need scrutiny. improving resilience requires building adaptive capacity, creating flexible organisations and fostering an organisational culture that promotes self-efficacy, innovation and questions the status quo. to promote building resilience, all stakeholders at every level of the process must be involved. an interactive exchange of ideas promotes growth of social capital and builds resilience. clarified framing and simple tools can promote a hotel's ability to understand, measure, and build resilience, moving more hotels toward embracing disaster resilience as an objective of value-worth the time, effort, and resources required. emergency preparedness for disasters and crises in the hotel industry framing disaster resilience: the implications of the diverse conceptualisations of "bouncing back community resilience to long-term tourism decline and rejuvenation: a literature review and conceptual model linking tourism into emergency management structures to enhance disaster risk reduction the tourism disaster vulnerability framework: an application to tourism in small island destinations the resilience of formal and informal tourism enterprises to disasters: reef tourism in phuket assessing social resilence interorganizational coordination: analysis 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the ability of individuals to complete their desired travel despite unplanned disruptions to the transportation system. the potential of new on-demand mobility options, such as ridesourcing services, to fill unpredicted gaps in mobility is an underexplored source of adaptive capacity. applying a natural experiment approach to newly released ridesourcing data, we examine variation in the gap-filling role of on-demand mobility during sudden shocks to a transportation system by analyzing the change in use of ridesourcing during unexpected rail transit service disruptions across the racially and economically diverse city of chicago. using a multilevel mixed model, we control not only for the immediate station attributes where the disruption occurs, but also for the broader context of the community area and city quadrant in a three-level structure. thereby the unobserved variability across neighborhoods can be associated with differences in factors such as transit ridership, or socio-economic status of residents, in addition to controlling for station level effects. our findings reveal that individuals use ridesourcing as a gap-filling mechanism during rail transit disruptions, but there is strong variation across situational and locational contexts. specifically, our results show larger increases in transit disruption responsive ridesourcing during weekdays, nonholidays, and more severe disruptions, as well as in community areas that have higher percentages of white residents and transit commuters, and on the more affluent northside of the city. these findings point to new insights with far-reaching implications on how ridesourcing complements existing transport networks by providing added capacity during disruptions but does not appear to bring equitable gap-filling benefits to low-income communities of color that typically have more limited mobility options. unexpected transit disruptions, service interruptions due to accidents, infrastructure breakdowns, and passenger distress are common occurrences in urban transit systems. the desire of riders is usually to continue their journeys to a timely completion -to be resilient in their travel. the current growth of ridesourcing services offers a novel opportunity for urban mobility resilience by filling unpredicted gaps in transit operations. in this study we examine the role of ridesourcing to enhance adaptive mobility to disruptions by complementing traditional services (reggiani et al., 2015) . specifically, we study the variation in this type of resilience across communities. we analyze the equity in ridesourcing for mobility resilience for the city of chicago. notably, chicago is home to the second largest transit network in the u.s. with the chicago transit authorities (cta) serving 3.5 million riders (cta, 2020a) with nearly 16 million rail rides each month (cta, 2020b) . while unequal access to essential resources is common in many u.s. cities, chicago contends with historically rigid, spatially-defined, social and economic inequality that is frequently linked to race. for example, the income divide between white households and minority households is wider in chicago than it is across the nation as a whole (asante-muhammed, 2017) . urban mobility systems typically grapple with multiple layers of inequitable mobility investments and service-access that determine service quality for different population segments. the city of chicago is subject to urban mobility inequity both at the service level (e.g., poor mobility accessibility coverage), as well as disproportionate impacts (e.g., lack of pedestrian-friendly infrastructure or biased policing) in low-income communities (krapp, 2020) . to understand how well a mobility system serves diverse community members, it is essential to understand the interplay between modes in the transportation system. on the one hand, public transit addresses the transportation needs of those with mobility disadvantages, implying that any disruptions in transit could disproportionately affect under-resourced communities of color. on the other hand, on-demand mobility services can offer expanded flexible mobility, although there is evidence of disparities in the use of ridesourcing related to spatial and sociodemographic diversity (soria et al., 2020) . this has led the local planning agency cmap to highlight the need to study the potential benefits and pitfalls of new mobility technologies, such as ridesourcing, with regard to accessibility, affordable mobility, and local quality of life (cmap, 2018) . our awareness of existing disparities in mobility begs a fundamental question when analyzing the substitution of ridesourcing services during transit disruptions: is this disruption recovery equitable; that is, are under-resourced transit riders benefitting from ridesourcing-based mobility resilience on par with other travelers? in this project, we take a natural experiment approach where we systematically identify major transit disruptions over the course of a year and match them with large scale, spatio-temporal ridesourcing trip data from the city of chicago. we then develop a multilevel model (mlm) to examine the degree to which ridesourcing demand surges during transit disruptions, providing evidence of an adaptive ridership response. the multilevel structure is tailored to account for variation in spontaneous mobility resilience across the city and to explore whether it occurs due to neighborhood differences. to examine this potential adaptation strategy among transit riders, we compare the demand for ridesourcing during unplanned rail transit disruptions to the baseline demand while also controlling for the time of day, day of the week, and location. the main contributions of this study are the insights it provides into: (1) whether ridesourcing is used as a gap-filling transportation mode during transit disruptions in chicago, (2) whether its utilization for this purpose is distributed equitably across the city in terms of racial and economic circumstances, and (3) whether variation in ridesourcing demand during disruptions is attributable to station-level, community-level, or quadrant-level contexts. our findings provide evidence of significant localized station-level effects, such as the timing of the disruption. importantly, we also discover that the community area where the station is located is responsible for the majority of the variation in observed disruption-based ridesourcing substitution. specifically, the racial composition and transit commuting rates show significant interaction with the aforementioned station-level factors. these insights contribute to an improved understanding of how riders cope with disruptions in different communities. in terms of practice, we discuss how our findings can guide more equitable communication strategies for transportation agencies and potential partnerships with private on-demand mobility service operators to treat mobility as a service regardless of transportation mode. transit disruptions may be long-term or unplanned, and their impacts can cause riders to shift to traditional modes (such as cars and buses) or on-demand mobility (such as bikeshare and ridesourcing). the effects of long-term transit disruptions on transportation behavior have been widely studied over the past decade (marsden and docherty, 2013; pnevmatikou et al., 2015; pu et al., 2017; van exel and rietveld, 2001; zhu et al., 2017) . long-term transit line closures may extend for several months, providing riders with time to adjust their behavior, including departure time, route, and mode, temporarily or permanently. often during long-term disruptions, such as transit strikes, the majority of travelers switch to cars (van exel and rietveld, 2001; zhu et al., 2017) . this may be a function of available resources, as those who are less likely to travel by car during transit disruptions include lower income individuals, women, and individuals with more flexible work schedules (pnevmatikou et al., 2015) . mode-shifting behavior during long-term transit disruptions depends not only on sociodemographics but also on the surrounding context, such as the city in which it occurs. longterm rail transit disruptions in washington, d.c. are associated with increased bus ridership (pu et al., 2017) , especially among lower income individuals (zhu et al., 2017) . by contrast, an analysis of smart-card data for chicago rail riders shows that the majority of riders continue to use rail during planned maintenance with a minor share shifting to bus (mojica 2008) . furthermore, the effects of long-term transit disruptions have resulted in a permanent decline in transit ridership across europe and the u.s. (van exel and rietveld, 2001; zhu et al., 2017) . similarly, in chicago, lengthy disruptions from track operations led to an estimated 3.9% of riders abandoning transit (mojica, 2008) . in the few cases of research on long-term transit disruptions that consider on-demand mobility, the focus has been largely on bikeshare. findings show temporary increases in bikesharing demand during transit strikes or maintenance projects, suggesting the ability of on-demand transportation to increase mobility resilience (fuller et al., 2012; kaviti et al., 2018; pu et al., 2017; saberi et al., 2018) . compared to the extensive body of research on planned, long-term transit disruptions, research on unplanned, short-term events has been scant (sun et al., 2016) . very recently, however, research has begun to consider the role of ridesourcing by transit users in response to unplanned service disruptions . one survey-based study, which is among the first to research transit rider behavior during unplanned service disruptions in chicago, examined whether riders would cancel their trip, change destinations, or change modes to shuttle bus, ridesourcing, taxi, personal vehicle, or carpool . the findings reveal that the individuals who would shift to ridesourcing during a transit disruption tend to be millennials, have a higher level of education, have a smartphone, or have prior ridesourcing experience . in the survey-based study, race was not found to be a significant factor in the hypothetical shift to ridesourcing. while earlier work has revealed the role of bikeshare as a gap-filling mechanism during longterm transit disruptions, so far, ridesourcing has only been investigated as a mode-adaptation strategy for hypothetical unplanned transit disruption scenarios. the current study is among the first to use a natural experiment to examine the impacts of unplanned, short-term transit disruptions on the usage of ridesourcing across the city of chicago. we believe that examining unplanned transit disruptions can improve understanding of adaptation strategies that substitute on-demand mobility for fixed transportation services. herein, we develop an mlm model to examine the magnitude of ridesourcing demand-surges due to transit disruptions. more importantly, we analyze the variation, especially related to racial composition, in the gap-filling utilization of ridesourcing and compare the disruption source and broader community-level contexts to explain this observed variation. due to the limited access of on-demand mobility by individuals with disabilities, low income or historically marginalized communities, rural populations, under-banked households, and individuals without smartphones, the ridesourcing business model has been accused of being based on privileged access (daus esq., 2016) . studies show consistently that ridesourcing users are typically young, male, higher income (zhang and zhang, 2018) , highly educated, full-time workers , own fewer vehicles per household, and live closer to transit stations (deka and fei, 2019) . similarly, users of a commute-focused vanpooling service formerly operating in seattle were mainly white, male, highly educated, higher income, and millennials (lewis and mackenzie, 2017) . other works highlight contradictory findings on declared hailingtransit substitution according to income segment and service quality factors (gehrke et al., 2018) . recent work based on large-scale trip data and experiments has revealed more aggregate demand insights. in chicago, greater ridesourcing usage is observed in areas with higher population and employment density, land-use diversity, household incomes, percentages of transit commuters, and percentages of zero vehicle households (ghaffar et al., 2020) . in seattle, areas with higher percentages of racial minorities experience longer wait times for ridesourcing services at night after adjusting for differences in income (hughes and mackenzie, 2016) , and in new york city, ridesourcing pickups are found to be less common in lower income areas (jin et al., 2019) . additionally, evidence of racial and gender discrimination has been identified in ridesourcing practices in boston and seattle (ge et al., 2016) . although a smaller body of research has found evidence of more equitable ridesourcing practices in some cities, such as longer wait times in areas with higher average income in seattle (hughes and mackenzie, 2016) or more frequent ridesourcing in low-income neighborhoods in los angeles by one trip per month while controlling for residential location (brown, 2019b), ridesourcing inequity is still a problem that needs to be addressed in many cities and for many groups. furthermore, findings that racial discrimination against riders may be worse among taxis than ridesourcing (brown, 2019a), still does not constitute evidence that ridesourcing is equitable on the whole. in terms of bikeshare, chicago has an embattled history of socioeconomic segregation leading to starkly different daily use patterns. biehl et al. (2018) shows that divvy uptake is lower in the less affluent southside even after controlling for station tenure and density. an early investigation of newly released chicago ridesourcing data suggests a similar concentration of rides in the more affluent north and central quadrants of the city (soria et al., 2020) . this context of on-demand mobility usage and equity helps to inform our variable selection and interpretation of revealed ridesourcing substitution behavior as it relates to sociodemographics at the station, community area, and city quadrant levels. this perspective offers a valuable contribution to the literature, because equity aspects of transportation resilience have traditionally been understudied (mattsson and jenelius, 2015) . twenty-eight chicago transit authority rail transit disruptions, listed in table 1 , are identified as having occurred during the period of november 2018 through october 2019 using a google news search for the phrase "cta disruption". we filtered cases to only include significant disruptions (i.e., lasting a minimum of one hour). the event-specific variables include the location (in terms of city side, quadrant, community area, and station), number of other stations impacted, disruption cause, disruption duration, deployment of shuttle buses, outside air temperature, weekday status, holiday status, peak hour status, late night status, and the cause being a medical emergency (cta, 2019). the ridesourcing data used in this study were obtained from the city of chicago data portal (chicago data portal, 2019) . the transportation network companies in the dataset include uber, lyft, and via. the entire dataset consists of over 152 million trips spanning the period of november 2018 through october 2019. the variables that we analyze in this study are trip start date and time, trip miles, pickup community area, and pickup census tract. the ridesourcing trip data is matched to the identified transit disruption days and comparable baseline operations. the starting location of each ridesourcing trip is identified by census tract or community area, and if that location is within a 0.25-mile radius of a disrupted transit station, the trip is included in the analysis. this frequently-used walking estimate (younes et al., 2019; zhao et al., 2003) is applied to account for riders who source rides on their way to or from the impacted transit station or who step away from the potential crowd surrounding the impacted station to facilitate pick-up by their ridesourcing driver. to generate a robust four-day ridesourcing demand baseline, trip counts during the disruption time period are averaged across the same day of week and time of day as the disruption for two weeks prior to the event and two weeks following. this assumes mode shifting behavior from transit to ridesourcing would typically not continue beyond two weeks following a single, unplanned transit disruption that lasts on average 2.5 hours. while this may be a conservative estimate, it avoids the risk of confounding changes in station accessibility and seasonality. the city of chicago is divided into 77 community areas, which can be further aggregated into four quadrants or sectors of the city: central, north, west, and south. the community area variables that we include in our analysis are the number of bus stations, number of divvy stations, station ridership, population density, area, airport presence, total population, median household income, percentage of zero vehicle households, percentage of commuters taking transit, and percentage of residents who self-identify as predefined categories of hispanic or latino, white non-hispanic, black non-hispanic, asian non-hispanic, or any other race and ethnicity category, according to five-year estimates from the american community survey (u.s. census bureau, 2017) and as reported by the chicago transit authority (cta, 2019), the chicago metropolitan agency for planning (cmap, 2019), and divvy (divvy, 2020) . sociodemographic data on riders of transit and ridesourcing are not available, so the socioeconomic characteristics of the surrounding geographic areas are used instead. multilevel mixed (mlm) modeling is designed to properly account for the hierarchical nesting of data and effects happening at different levels (goldstein, 2003; julian, 2001; wampold and serlin, 2000) . mlm models provide a mechanism for analyzing datasets where observations (in this case, station disruptions) are nested within higher-order spatial contexts, such as neighborhoods. in the past, mlm or hierarchical models have been used to represent the structure of social relations within personal networks (carrasco and miller, 2009) , temporal changes in bike share trips (el-assi et al., 2017) , and transit demand between origin-destination station pairs (iseki et al., 2018) . we use a multilevel regression analysis to identify the station level, community area level, and city quadrant level factors associated with systematic variations in ridesourcing demand during transit disruptions. we can thereby examine explanatory variables at each level of the data hierarchy, and in doing so, control for community area effects on station ridership variation. the advantage of using the multilevel structure is the ability to estimate the variability in results that can be attributed to neighborhood (e.g., community area) effects rather than only to individual station effects. by carefully controlling variable-inclusion at the appropriate level, the model takes into account correlations between observations within the same group (i.e., a given community area) as distinct from correlations between groups (jones and duncan, 1996) . instead, a standard one-level regression model would ignore group-level distinctions (for example, different commuting patterns in different communities) and group level correlations (for example, similar patterns of use among stations in the same community related to the income-level of riders). a useful way to think of mlm models is as a structure sitting between two modeling extremes when groupings are known: fully pooled and fully unpooled specification (gelman and hill, 2007) . a fully pooled model treats group-level variables as individual variables, thereby ignoring grouplevel distinctions. the opposite extreme, a fully unpooled model, asserts that the groups are so completely different that they cannot be associated in the same model. the mlm model offers a compromise between complete distinction of groups and the complete ignorance of group-level effects by modeling individual-level fixed effects as well as distributional assumptions on the random effects. to address the research question of ridesourcing surges triggered by transit disruptions, we control not only for the immediate station attributes where the disruption occurs (level 1), but also for community area (level 2) and quadrant (level 3) factors in a three-level structure. fig. 2 shows the hierarchical, three-level model framework. the dependent variable is the number of ridesourcing trips compared to the baseline demand two weeks prior and two weeks following the disruption (i.e., individual station observations). covariates related to the disruption cause, context, and timing are included as explanatory variables at this level, in line with mojica (2008) and pu et al. (2017) . we further investigate whether the fact that stations are nested within community areas and major quadrants plays a role in ridesourcing demand shifts. it is likely that a comparable disruption can generate different mode-shifting effects depending on where it is located, owing to the different composition of travelers and availability of alternative modes. specifically, the broader context is controlled for by including sociodemographic and mobility factors measured at the community level that are in turn aggregated to the quadrant level of analysis. it is worth noting that since the disruptions we measure result from a natural experiment, we are unable to control exhaustively for all combinations of factors that are at play within and between community areas. therefore, we include random intercept effects at each of the lower-nested group levels to partition the unexplained variability effects on the dependent variable. conceptually, the model can be articulated as regression equations occurring at different levels where each group-level coefficient has its own regression equation. following gill and womack (2013) , the general three-level structure is defined in eq. 1 as: where i represents the station, j represents the community area, and k represents the quadrant. '#$ is the (random) intercept measuring average ridesourcing use (defined in eq. 2), and )"#$ is a predictor, such as the average daily transit use measured at the station level, while )#$ is the (random) slope depicting the relationship between the station-variables and the change in ridesourcing demand (as defined in eq. 3). the error term "#$ relates to station-level effects. by including level 2 and 3 explanatory variables in the model, we uncover context-level effects. namely, we account for variability in coefficients at the station level owing to community area or city quadrant level factors. level 2 includes variables aggregated to the community area level expected to impact all stations in the area. this can be thought of as being equivalent to the way in which student educational performance is affected by their classroom teacher in a way that is distinct from the effects of their individual factors or from more aggregate school-level effects. the subscript jk denotes the distinct community area impacts. the é£ has numbered subscripts, the first denotes the intercept (0) or slope (1), while the second subscript denotes the independent variable. at level 2, the general regression equations are defined as: where the random intercept '#$ is a function of é£ ''$ , the grand mean of ridesourcing demand surges across stations in the community (defined below in eq. 4). departures from this average intercept represented by -#$ are community-level predictors with é£ ')$ denoting the random slope for community level predictors (eq. 5), and '#$ is the unique effect associated with communities assumed to have a multivariate normal distribution. the random slope )#$ is a function of é£ )'$ representing the average effect of the station-level predictors (i.e. the slope over all stations shown in (eq. 6)). departures from the slope (i.e., random effects) over station predictors are represented by the é£ ))$ coefficient (eq. 7) that would be removed for a random intercept-only model (as in the current case). at level 3, variables vary by quadrant and apply to all individual cases and community areas assigned to this group. therefore, they contain the subscript k as opposed to ijk or jk. at level 3, the separate regression equations for the intercepts and slopes are defined as: é£ )'$ = ) + 4 1$ + )'$ (6) é£ ))$ = 1 + 5 1$ + ))$ where ' is the intercept shared by all individual cases, ) , -, and 1 are the main effects, 0 , 3 , and 4 are two-way interactions, and 5 is a three-way interaction. in our specific modeling, the outcome variable of the three-level hierarchy "#$ is defined as the change in ridership over baseline. after specification testing, the final model takes the forms shown in eq. 8-16. the model includes a random intercept '#$ and two main effects ( _â�� "#$ and _â�� "#$ ) at level 1, shown in eq. 8. level 2 brings in contextual variables used to explain variability in ridesourcing demand via cross-level interactions. that is, now we model the intercept and slopes explicitly, and include level-one and level-two independent variables interacted to describe variation in the intercept. eq. 9-11 shows the random intercept é£ ''$ and the cross-level interaction terms ( _ â�� #$ ã� _â�� "#$ and _ #$ ã� _ "#$ ). level 2 also specifies )#$ and -#$ which represent the parameter slopes with é£ )'$ and é£ -'$ . level 3 includes the random intercept ' and one quadrant level interaction ( â��_ $ ã� â�� "#$ ) that is found to generate variability in ridesourcing (eq. 12), with remaining parameters ) anddenoting the fixed slope coefficients. the disturbance parameters are included at the community '#$ and quadrant levels ''$ (eq. 15-15). it is important to note that the cross-level interactions explain a significant amount of variance of ridesourcing demand changes in addition to that already explained by the station-level equations. level 1 model ''$ ~ (0, s -) the descriptive analysis suggests that a significant surge in the use of ridesourcing does occur following no-notice transit line disruptions, as suggested in fig. 3(a) . this depicts a high-impact northside case in lake view at the belmont station (the source of the disruption) on a monday in december during morning peak hours. the disruption cause was a train striking a person. for reference, the baseline ridesourcing demand for this timespan and location is 807 rides. the disruption is associated with a significant surge in ridesourcing requests, totaling 2,883 and corresponding to an increase of 257% (a t-test of the disruption versus the baseline means has a pvalue of 0.00001). however, ridesourcing adaptation is not uniform across the city. a different case is shown in fig. 3(b) of a similar disruption event, this time occurring in an under-resourced westside neighborhood where there appears to be limited shifting towards on-demand services. this shows a low-impact case in east garfield park at the kedzie station (the source of the disruption). similar to the belmont disruption, it occurred during weekday morning peak hours and was caused by a person on the tracks. the baseline ridesourcing demand for this time and location is a fraction of that at belmont: 89 rides. the number of ridesourcing rides during the disruption event is lower than the baseline at 76 (-15%), which is not a significant change (a t-test of the disruption versus the baseline means has a p-value of 0.3984). given that lake view has a median household income of $86,119 and 79% of its residents are white, while east garfield park has a median household income of $23,116 and 5.6% of its residents are white, this behavioral difference could be tied to racial and economic inequity. to examine the different patterns of ridesourcing demand shifts triggered by transit disruptions systematically, we turn to the model results. table 2 , the mlm model includes both station-level (level 1) fixed effects (nonholiday disruption and peak hours disruption), which are similar to standard regression parameters, and explanatory features that reflect the context surrounding the station: namely, two cross-level random effects (percent white during peak hours and percent transit commuters at the source of disruption), and one quadrant-level effect (shuttle deployment in the north quadrant). all parameters are significant to a 98.9% level of confidence or greater except for the model constants. the model also includes random intercepts for the community area (level 2) and city quadrant (level 3) effects. first, we estimate a null model that partitions the variance at each level without including any explanatory variables. this enables us to calculate the intraclass correlation (icc), also known as the variance partition coefficient, for three levels, following snijders and boskers (1999) . this statistic measures the correlation among data at the lower levels to determine how much of the variation in ridesourcing demand is accounted for by variation among community and quadrant level factors. a smaller variance partition coefficient indicates that the variation in ridesourcing shifts is attributable more to variation among lower-level units (such as stations) than to that among upper-level units (like community areas and quadrants). the empty mlm model (model 1) thereby provides an estimate of baseline variance of ridesourcing demand shifts due to factors beyond the immediate station. the intra-quadrant correlation is small and suggests that 20% of the variance of the dependent variable is due to quadrant-level effects. in contrast, the intra-community correlation reveals that the largest share of total variance (43%) is related to community-level factors, suggesting that the lowest level of analysis (the station level) explains the remaining variance (37%). this indicates the largest share of the variation in ridesourcing demand substitution is related to factors that occur across communities, followed by the station level. the evolution of the variance estimation deserves attention. when adding station-level independent variables in model 2, the quadrant random intercept and thereby icc is shown to be insignificant, while the variance is now partitioned between the station (44%) and community area levels (56%). along the same lines, when adding cross-level effects by including variables measured at the community area level, the variance explained clearly pivots toward the community area variables (model 3). we note that despite the level 3 quadrant random intercept collapsing to zero, removing this variance component from the analysis causes a significant reduction in overall model fit. this analysis of random intercepts points to two important observations. first, the variance partitioning shows the importance of controlling for variables measured at the neighborhood factors that would have been overlooked in a standard regression solely focused on station substitution analysis. moreover, the inclusion of more explanatory factors leads to the absorption of more variability in the ridesourcing demand shift at the neighborhood levels. the main takeaway from the variance controls is the following: the differences between factors occurring across different community areas in the city are the most decisive in shaping the ridesourcing demand shifts following disruptions. we interpret this to mean that there are significant latent neighborhood effects at play in the shift to ridesourcing during transit disruptions. to model systematic variables, we follow the block entry approach consisting of the gradual addition of covariates level by level (cohen et al., 1983) , following the plan previously outlined in fig. 2 . first, each of the hypothesized predictors measured at the station-level are tested independently, then jointly. owing to high variable collinearity, only two fixed-effect explanatory variables related to the timing of the disruption and a constant are included in the resulting model 2. these statistically significant effects result in a significant improvement in model fit as measured by the deviance difference (836.99 -822.10 = 14.89, exceeding the critical ï� 2 of 5.99 with alpha set at .05) and aic reduction. looking at the constant, the model suggests a moderate average increase of 54 ridesourcing trips (or 15.6%) during a transit disruption, compared to baseline. to contextualize this finding, we note that the average baseline ridesourcing ridership is 347 trips across the chicago community areas covered in the disruption analysis. this value can be seen as the ridesourcing demand that would be occurring for the same station and timespan without the disruption. with this baseline in mind, the timing of disruptions is revealed to be highly impactful. on average, when a disruption occurs on a weekday (excluding holidays), ridesourcing rides increase by 541 from baseline (a 156% increase). when a transit disruption occurs during peak hours, ridesourcing demand increases by 408 rides from baseline (a 118% surge). the analysis suggests the existence of some citywide trends related to the timing of no-notice disruptions, likely related to less flexible trips during peak hours and weekdays. this finding is not surprising considering that business and commuting trips are more likely to be shifted to another mode than canceled, which has been shown for pre-planned disruptions (van exel and rietveld, 2009 ) and for unreliable metro services (pnevmatikou and karlaftis, 2011) . the novelty of our findings refers to the degree of shifting towards on-demand ridesourcing, a mode which has not been considered in previous work, which has been dominated by car substitution and transit replacement analysis. for completeness, following the fig. 2 modeling framework, we note that we are able to find no consistently significant impact of temperature, deployment of shuttle buses, number of nearby bus or divvy stations, nor general transit commute ridership. this is somewhat surprising given that the research on consequences of long-term transit disruption shows that the context (e.g., spatial or temporal) results in different rider adaptation strategies. therefore, we had expected specifically that modal alternatives (e.g., buses, bikeshare, etc.) would impact ridesourcing. for example, given previous research findings on the role of bikeshare as an adaptive strategy during long-term transit disruptions in washington, d.c. and london, we had expected to find that the availability of nearby divvy bikeshare stations would significantly decrease the observed shift to ridesourcing during unplanned transit disruptions. however, this was not the case, possibly due in part to trip purpose, travel distance, local bikesharing culture, and/or the inconvenience of requesting a membership in response to a single unplanned disruption. nevertheless, from the icc calculation in the current study, we know that the community area context is the main source of unexplained systematic differences in ridership shifting strategies. these neighborhood effects likely vary as a function of ridership culture (including car, transit, and ridesourcing culture), socioeconomic and political factors, and transportation agency strategies. while it is possible that some of these effects could be measured narrowly around the disruption events (i.e., stations), we note that the mlm enables us to analyze important factors like population density, median household income, and racial composition measured at more aggregated levels. the next section seeks to pinpoint the systematic factors that can explain the observed stochasticity. a fundamental goal of this multilevel analysis is to estimate the variability in ridesourcing use that can be attributed to community area level characteristics rather than to individual station factors and to identify how these components of variation change with the inclusion of predictors that quantify the context. in model 3, we hypothesize that the context surrounding the disruption also plays a role in determining the transfer of ridership from transit to ridesourcing during nonotice events. specifically, we hypothesize that the rate of ridesourcing substitution is associated with sociodemographic privilege, in line with earlier research (deka and fei, 2019) . this guides the inclusion of a number of predictor variables measured at the community area (not station) level in the form of cross-level interactions, including factors such as zero car households and population density. we apply group mean centering for community area variables (enders and tofighi, 2007) to facilitate the interpretation of the cross-level interactions. model 3 reveals a significant impact of two community area level factors; racial composition and percent of transit commuters. the addition of these cross-level factors leads to significant improvements in goodness-of-fit measured by the deviance difference and aic. while the crosslevel effects look comparatively small, they need to be related to the percentage unit of the variable measurements. the positive effect associated with the interaction term for percentage of white residents in the community area with the dummy variable for peak-hour travel (a coefficient of 12.3 additional trips) provides insight into the combined effect of race composition in the local area on the previous peak-hour effect findings. namely, across community areas, the peak-hour impact (353 added trips) is further boosted when disruptions occur in communities with higher shares of white residents. the implied difference is that, other things equal, a disruption occurring in a community area with a 10% higher share of white residents would result in a boost of 120 (or 34.6%) ridesourcing trips compared to the average peak-hour baseline. recalling that communities of color in chicago are more likely to be under-resourced in relation to job accessibility, transit supply, and on-demand mobility, we believe this finding is more likely a reflection of gaps in access to resources in areas with lower shares of white residents than of a lower willingness to use ridesourcing during disruptions. this finding adds to existing evidence that ridesourcing, in this case as a disruption gap-filling resource, gives more benefit to privileged user groups (zhang and zhang, 2018) . additionally, a novel effect is found related to the proportion of transit commuters in the community area and the incident location. on the whole, every percentage unit increase in transit commuting in the community area results in 18 added ridesourcing trips (or a 5.2% increase). however, this effect only occurs at the station where the incident responsible for the disruption is occurring. we speculate that transit commuters more readily shift to hailing services when they experience the disruption and receive information about it directly. in other words, riders at the source of the disruption are likely to have more information regarding the nature of the disruptive event from official sources and other riders, which will likely factor into their adaptation strategy. on the other hand, in areas with less transit commuting, there is presumably less collective experience with disruptions and therefore a higher likelihood of shifting to other private modes. despite there being no unexplained systematic differences related to the quadrant level beyond model 1, we conduct a model search to look for further impactful interactions including quadrant dummies for the four parts of the city. the model suggests a surprising finding. in the north quadrant, when a shuttle is deployed, ridesourcing rides increase by 321 instances (or 92.5%) from baseline. the deployment of replacement bus services during rail disruptions is the most common agency response (pender et al., 2013) . yet, there appears to be an unintended negative effect of this strategy. that is, the deployment of added transit bus capacity to assist riders should not boost ridesourcing requests. we interpret the unexpected increase in ridesourcing to be related to the signaling effect of this action. riders could perceive bus deployment as a strong cue for the severity of the disruption, or they may fear excessive crowding on the buses, both of which justify the decision to use ridesourcing. the north quadrant is home to the biggest share of disruptions in our dataset (16/28 or 57%), as well as heavy transit demand by commuters (fig 1.d) . the fact that replacement bus deployments trigger more ridesourcing substitution in the north quadrant is likely related to the higher income levels among commuters in this corridor. given the situational and locational contexts impacting the use of ridesourcing as an adaptive transportation strategy, it is important to consider the potential mobility resilience inequity across the city. if ridesourcing as a gap-filling mechanism is mainly associated with mandatory travel, disruptions of greater severity (i.e., requiring the deployment of a shuttle bus), and community areas with higher percentages of white residents and transit commuters, its role in mobility resilience is specific, selective, and unlikely to address existing issues of mobility inequity. specifically, our findings show that riders in areas with a higher proportion of non-white residents are less likely to divert to ridesourcing in times of disruption. this result does not in itself suggest supply inequity. however, when taking into account the fact that gaps in mobility services disproportionately impact communities that lack good access to transportation, the finding raises an important issue. under-resourced communities with poorer accessibility options would benefit the most from access to more adaptability options in the face of transit disruptions, and ridesourcing could play a greater role in this adaptation portfolio. taken together, our findings point to an opportunity to increase equitable mobility resilience by addressing the barriers that limit access to on-demand transportation. this highlights the need to consider socioeconomic constraints in disruption response planning and to fill service gaps through collaboration between transit providers and ridesourcing companies. when a major transit disruption occurs, riders may not be well-informed of the reason for the disruption or the expected duration. typically, some information is provided to passengers already on a transit platform, and only a brief description of a service alert may be offered online. however, this information may not be timely or may be generic or incomplete, making it difficult for passengers to develop informed response strategies. in this paper, we show how riders spontaneously respond to disruptions by substituting transit with ridesourcing. in some settings this occurs despite agency efforts to appease their passengers. for example, ridesourcing demand surges more when shuttles are deployed or when the disruption occurs at the traveler's station. through improved communication, transit providers could advise travelers of when and how to seek alternative transportation means and efficiently inform ridesourcing companies of disruptions. given this information, ridesourcing companies and drivers could work in tandem with route-around bus services to meet spikes in demand and avoid exploiting the situation through surge pricing. the flexibility of ridesourcing services offers on-call availability to provide extra capacity, while buses are able to maintain fixed routes for prolonged periods of time. in some cases, it might actually be cheaper for transit carriers to subsidized shared ridesourcing instead of delivering shuttle buses. by communicating the nature of the disruption and anticipated needs, transit agencies could engage ridesourcing drivers in adaptive, gap-filling services to address unplanned disruptions and reduce the adverse impacts experienced by transit riders. while collaborations between transit providers and ridesourcing companies may provide a way to decrease disruption response time and assist a greater number of affected travelers, these partnerships are not without challenges. most notably, transit providers are required to ensure fair service to all individuals in accordance with title vi and the americans with disabilities act, while ridesourcing services are not currently held to the same standards. another crucial challenge is the negotiation of data and information sharing among public transit agencies and private transportation providers. public-private data-sharing partnerships are an important collaborative mechanism through which governmental agencies and ridesourcing companies may develop datasupported policies to fill transportation gaps while protecting user privacy (cohen and shaheen, 2018). our findings suggest that transit riders in areas with a higher proportion of non-white residents and in less affluent quadrants may be left out of the option to shift to on-demand ridesourcing during unplanned transit disruptions. in this section we discuss how the joint goal of providing mobility adaptiveness and achieving transportation equity, can be achieved across three levels of analysis: spatial, economic, and social. first, existing spatial inequities in chicago have resulted in low-income communities and communities of color experiencing long-running transportation challenges. residents in these communities are subject to spatial mismatch, have less accessibility to public transit within walking distance, and experience longer commutes, summarized as having fewer livability opportunities (ferrel et al., 2016) . underlying mobility inequity at the spatial level can be addressed by transportation policymakers through partnerships between public transit agencies and ridesourcing companies and by providing more micro-transit in lower-density areas. second, economic inequity is apparent in the distribution of resources that are needed to use ridesourcing, including direct costs (e.g., proportion of income spent on fares) and indirect costs (e.g., smartphones, credit cards, and internet access). as urban areas become more digitally integrated, offering residents greater mobility resilience to disruptions through on-demand ridesourcing services, those on the underserved side of the digital mobility divide are left further behind. practical measures to combat direct and indirect costs include providing lower income commuters or travelers with subsidies or vouchers for lower cost access to ridesourcing during transit disruptions, access to smartphones, multi-modal hubs with internet access, and unbanked payment options similar to transit smartcards. third, social inequities refer to existing racial, cultural, and language barriers to ridesourcing usage. for example, there is a potential supply equity challenge in light of the evidence that communities of color experience longer ridesourcing wait times than non-white communities in seattle (hughes and mackenzie, 2016) , also suggested for chicago (cnt, 2019) . longer wait times can be especially troublesome for peak period commuters. to address social inequities, such as supply inequity wherein the opportunity to use ridesourcing is not readily available to all communities, there is a need to consider ridesourcing incentives, safety initiatives, and driver training on socially equitable practices to minimize sociodemographic profiling. to combat poorly targeted marketing, transportation agencies could offer information campaigns and outreach programs geared toward historically underserved communities that highlight equitable transportation initiatives to improve adaptability and resilience during travel disruptions. in particular, it is important that under-resourced communities have a say in the decisions that impact them through bottom-up concept generation and participatory policymaking. ultimately, agencies may shift toward the idea of mobility as a service. if transit operators, like the cta, were to adopt a mandate to deliver stop-to-stop service despite unplanned disruptions, they might internalize the responsibility of providing transportation alternatives when a disruption occurs. this lack of separation between agencies and domains may represent the future of transportation operations, and public-private partnerships between transit agencies and ridesourcing companies may provide a first step toward making this future a reality. to meet service quality constraints, the on-demand rapidity of ridesourcing service response could be advantageous. if deployed ridesourcing was moreover provided as a pooled service, it might be more cost efficient for transit agencies than a shuttle service, which requires equipment maintenance by the cta and short-notice driver availability (shared-use mobility center, 2020). furthermore, such partnerships would be beneficial to have in place ahead of long-term transit service disruptions, such as those observed during the covid-19 pandemic. for example, the la metro in the los angeles region was able to leverage a preexisting partnership with the ridesourcing company via during the pandemic by expanding their role from providing first-and last-mile services to private, point-to-point trips to accommodate essential travel (grossman, 2020) . this exemplifies the ability of public-private partnerships to increase mobility resilience to unexpected disruptions. while this study is among the first to examine impacts of unplanned transit disruptions on the usage of on-demand ridesourcing services across the city of chicago, some caveats warrant discussion. first, information on transit disruption and shuttle bus deployment were gathered from local news sources and are subject to source accuracy. for the analysis, assumptions were made that disruptions lasted the same duration at each affected station and that shuttle services (when provided) were deployed to all affected stations. second, determining the spatial band where riders change travel behavior is complicated to determine and depends in part on their location when informed of the disruption, as well as their intended destination. we consider mode-switching behavior within a 0.25-mile radius of each affected station which is likely to underestimate the true degree of shifting. particularly, mode-shifting behaviors may have occurred across a broader time-space domain, including travelers who learned of the disruption prior to departure. third, we use aggregated measurements of community variables as a proxy for individual-level attributes, which masks variation in socioeconomic characteristics of riders. the characteristics of the actual riders aboard the train and the areas in which they reside are unknown. despite these limitations, which are all associated with the use of a natural experiment approach, our research contributes new insights that would be difficult to gage using smaller scale stated data. namely, we capture the actual circumstances of the disruptions leading to adaptive use of ridesourcing. importantly, the findings of this study bring to light which community groups are able to shift to on-demand mobility during a disruption and who is left behind to seek out other alternatives. our findings suggest two main avenues for future research. first, to better gage socioeconomic distributions of mobility resilience, further collaborative research should aim for a more nuanced analysis of the behavioral adaptations practiced by transit riders who do and do not shift to ondemand mobility. for example, access to disaggregated data on ridesourcing pickup locations with rider sociodemographics matched with spatio-temporal bus ridership would reveal more detailed insights into a user-based (in)equitable distribution of multi-modal, context-specific adaptive strategies that are enacted to complete disrupted travel (i.e., our measure of mobility resilience) across disaggregated marginalized populations. second, the latent area effects observed in this multilevel analysis suggest that future work should investigate the impacts of mobility culture, values, and attitudes surrounding the use of ridesourcing as an adaptive mobility strategy. better understanding of latent constraints would enable the tailoring of transportation policies by area to improve equity and adaptability, thereby enhancing mobility resilience. while research on the provision of information to riders and their observable reactions is extensive (leng and corman, 2020; sarker et al., 2019 , ben-elia et al., 2013 , mahmassani & liu 1999 , there is still a need for an empirical understanding of adaptation decision-making to recover from unplanned travel disruptions in the presence of ridesourcing options. in this study we use a natural experiment design to identify the main determinants of ridesourcing substitution as an adaptive response strategy during unplanned transit disruptions. our findings reveal that spikes in ridesourcing demand are strongly tied to peak-hour and weekday travel, suggesting a city-wide effect of mandatory travel. however, the relationship between transit disruptions and ridesourcing substitution behavior is also influenced by the temporal and spatial context in which the disruption occurs. peak-hour disruption shifts to ridesourcing are positively correlated with the percentage of white residents in the surrounding community area, which suggests potential accessibility inequity in terms of options for mobility adaptation (i.e., resilience). that is, riders in areas with higher shares of non-white residents are less likely to turn to ridesourcing for mandatory travel during transit disruptions. this suggests a greater vulnerability of racial minorities to the negative impacts of transportation disruptions. inequitable access to multiple (redundant) and robust mobility options needs to be addressed by transit agencies and transportation policymakers. in this paper we outline and discuss two policy perspectives arising from these findings, namely public-private partnerships and information campaigns, and a three-level framework for agencies to think more broadly about mobility justice initiatives. a comparison of the personal and neighborhood characteristics associated with ridesourcing, transit use, and driving with nhts data centering predictor variables in cross-sectional multilevel models: a new look at an old issue effects of built environment and weather on bike sharing demand: a station level analysis of commercial bike sharing in toronto handbook for building livable transit corridors: methods, metrics and strategies. 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analysis for the washington dc metrorail system uber, public transit, and urban transportation equity: a case study people and places: the multilevel model as a general framework for the quantitative analysis of geographical data. spatial analysis: modelling in a gis environment the consequences of ignoring multilevel data structures in nonhierarchical covariance modeling impact of pricing and transit disruptions on bikeshare ridership and revenue. transportation transportation equity project: prioritization criteria the role of information availability to passengers in public transport disruptions: an agent-based simulation approach uberhop in seattle: who, why, and how? transportation research record dynamics of commuting decision behavior under advanced traveler information systems insights on disruptions as opportunities for transport policy change vulnerability and resilience of transport systems-a discussion of recent research examining changes in transit passenger travel behavior through a smart card activity analysis (doctoral dissertation, mit) metro service disruptions: how do people choose to travel? state of transportation in a day without metro in the washington region analysis of transit users' response behavior in case of unplanned service disruptions transport resilience and vulnerability: the role of connectivity understanding the impacts of a public transit disruption on bicycle sharing mobility patterns: a case of tube strike in london applying affective event theory to explain transit users' reactions to service disruptions dynamics of travelers' modality style in the presence of mobility-on-demand services multilevel analysis: an introduction to basic and advanced multilevel modeling 2020) k-prototype segmentation analysis on large-scale ridesourcing trip data estimating the influence of common disruptions on urban rail transit networks public transport strikes and traveller behaviour the consequence of ignoring a nested factor on measures of effect size in analysis of variance how transit service closures influence bikesharing demand; lessons learned from safetrack examining the relationship between household vehicle ownership and ridesharing behaviors in the united states forecasting transit walk accessibility: regression model alternative to buffer method travel behavior reactions to transit service disruptions: study of metro safetrack projects in this research was supported in part by funding from the national defense science and engineering graduate (ndseg) fellowship provided to borowski. stathopoulos was partially supported by the us national science foundation (nsf) career grant no. 1847537. key: cord-034634-7jo3y89b authors: ridzi, frank; prior, trina title: community leadership through conversations and coordination: the role of local surveys in community foundation run community indicators projects date: 2020-11-04 journal: int doi: 10.1007/s42413-020-00098-z sha: doc_id: 34634 cord_uid: 7jo3y89b community indicators (ci) projects rely on a variety of sources for the data that they make available to measure community well-being. while statistics collected and distributed by national and local governments are perhaps the most prevalent, some communities in both canada and the united states have found great advantages to commissioning or administering their own surveys of local community members in order to enhance the insights that government-curated data can provide. in this paper we examine two organizations engaged with indicator projects that have opted to do so from the perspectives of their primary ci project supporters: the vancouver foundation in canada and the central new york community foundation in the united states. among the advantages explored are increased capacity in key community leadership elements of: engaging residents, working across sectors, commissioning and disseminating local data and research, shaping public policy, and marshaling resources. we conclude by reflecting on the many synergies between the ci and community foundation (cf) movements, paying attention to their shared interests in community well-being through better conversations and coordination among the organizations in the communities they serve. community well-being is a multifaceted and interdisciplinary concept that invites a variety of frameworks as well as industry sectors to participate in its study and improvement (phillips and lee 2019) . while a shared definition may be elusive, two key dimensions have helped to give shape to this growing field of study: 1. indicators used to measure community well-being (sung and phillips 2018) and 2. action being taken by local community members and anchor institutions to improve community well-being (sirgy 2018) . in the following pages we explore how two international movements, the community indicators (ci) movement and the community foundation (cf) movement, have characteristics that naturally position them to contribute to our understanding and improvement of community well-being. we then review how both movements have experienced increasing focus on local community well-being -ci increasingly focusing on localized data and cfs increasingly focusing on their deep knowledge of and ability to effectively take action to improve local communities. to further explore this increasing interest in local data and knowledge about community well-being, we then turn to two case studies where these movements have joined forces in the form of cf led ci projects, one in canada and one in the united states. we first provide context on the origin and development of these cf initiated ci projects before examining how their reliance on federally funded, and publicly available, data about their local communities proved insufficient to address the desire for knowledge about their local communities' well-being. we then profile innovative solutions to this problem and the new opportunities and capabilities local survey initiatives have created. community well-being is a multifaceted concept that revolves around place and geography. it has historically been articulated in a variety of ways but often includes economic, social and physical community dimensions (sirgy 2018) . though hard to define, there is general consensus that community well-being involves many interconnected parts that make it complex and hence well suited to interdisciplinary study in fields such as geography, sociology, political science and environmental and cultural studies (phillips and lee 2019) . this has led to broad conceptualizations such as kee et al.'s (2015) multidimensional model that includes the following six types of capital that a community can possess: human, economic, natural, infrastructure, cultural, and social (lee and kim 2018) . regardless of the dimensions included, community wellbeing is defined by the word "community" which typically refers to a specific local geography such as a city or town (phillips and lee 2019) . in addition to referencing a specific geography, two things that have historically been helpful in defining community well-being are: 1. indicators and 2. action. as we will explore in the future pages, both are points of synergy between the cf and ci movements. in the field of community well-being, indicators have been valued for their usefulness in "conceptualizing and assessing community wellbeing" (sung and phillips 2018) . it is not until we begin to try to measure whether a community's well-being is high or low that we are faced with the many possible approaches we can take. indicators help us translate our theoretical ideas into concrete, operational terms and force a degree of pragmatism on the study of well-being. after all, if well-being cannot be measured it is difficult to study using the standard tools of social science. the result is a robust literature on indicators of community well-being that is guided by such theoretical perspectives as "socio-economic development, personal utility, just society, human development, sustainability, and functioning" (sirgy 2018 :6, ridzi et al. 2020 . rather than an afterthought, indicators and quality of life have evolved as intertwined concepts with some tracing the concept of quality of life and well-being itself to the us "social indicators movement" of the 1960s (lee and kim 2018:34) . the goal of taking action to improve the well-being is another defining characteristic of the field of well-being studies. this is a goal as well for the ci movement (and as we shall see of the cf movement) but it is also part of a symbiotic relationship such that in the words of sirgy (2018) "many community conditions are outcomes of community action (p. 4)." hence action (or inaction as the case may be) is in many ways implied in the notion of indicators. nevertheless, making the connection between indicators and action is itself a defining feature of the field as well-being and quality of life studies scholars have increasingly called for stronger connections between well-being studies and action in such forms as public policy (lee and kim 2018) . this is another way in which well-being and indicators are interwoven. as warner (2014) has pointed out, "a common thread among different indicator projects is the desire to find the right measures to influence policy and action (p. 45)." the increasing focus on connecting the study of well-being with indicators-style measurement and action is most visible at the local level (lee and kim 2018) . some examples include community indicators victoria (australia), jacksonville indicators (united states), sustainable seattle (united states), calgary indices of community well-being (canada), and the world bank's city indicators project (lee and kim 2018) . warner (2014) provides some further context to this local push for indicators and action by chronicling how the common frameworks that dominated quality of life studies (sustainability, healthy community, and government benchmarking) were augmented in the early 2000s with a more subjective approach to well-being in such forms as questions of happiness and public happiness. 1 this focus on measures of subjective well-being opened the door to collecting data beyond typically collected and reported census-style data and government administrative records. as sirgy (2018) has pointed out, ci projects seeking to capture residents' perception (such as happiness) and to assess the condition of community services have been forced to resort to community surveys. while requiring greater investment of local resources, it plays into one of the strengths of cis in its emphasis on the local. as warner has argued (2014), "from inception, the greatest strength of the community indicators movement was perhaps the ability to hyper-localize measures of community well-being (p. 54)." in this increasing emphasis on the advantages of local focus and data granularity we see a parallel with the community foundation movement. what has been referred to as the "community foundation movement" (harrow et al. 2016; sacks 2006 , community foundation atlas 2014 2 ) is a parallel trend to the ci movement that has also occurred internationally (but with a large contingency in the united states and canada). the cf movement focuses on action to improve community well-being. recent years have seen growth in a variety of place-based funders (in the united states and globally) (harrow et al. 2016; mazany and perry 2014:12) but cfs in particular have seen such massive expansion that nearly 75% of those that exist today were created in the last 40 years (leonard 2014:108) . though cfs are known to play a variety of roles including investor, convener, partner, and supporter (philipp and traylor 2014:128) , they can fundamentally be understood as charitable mechanisms designed, "to promote sustained community-based philanthropy and to address changing local needs (walkenhorst 2010:7)." they do this mainly by soliciting donations, managing bequests and generally serving as a community's permanent charitable endowment that exists to invest donations wisely and using a prudent spending rate. earnings are then reinvested back into the community through funding nonprofits to do work ranging from the arts and human services to animal welfare and environmental stewardship. dating back to 1914 3 the cf movement in the united states has prospered from changes in tax laws that have given them advantages over private foundations and allowed for the proliferation of donor-advised funds (harrow et al. 2016; carson 2014:47; leonard 2014: 108) . the popularity of donor-advised funds effectively shifted the audience and accountability structure of cfs such that the majority of their business was living donors by the 1980s (leonard 2014:108) . this not only helped to drastically increase the number and size of cfs, but it also placed them in competition with forprofit financial sector products such as those offered by fidelity investments which allowed financial planners to also offer to help charity-minded citizens make donations back to their communities (ballard 2007 , leonard 2014 . as competition increased, cfs increasingly sought to articulate their market advantage as a profoundly more intimate knowledge of the local communities they serve (harrow et al. 2016; mazany and perry 2014; ballard 2007) . a key part of this is a nuanced sensibility about the local needs and assets that together bring about the community's well-being and quality of life. community foundations have expressed that they have a 'finger on the pulse' of the local community in a variety of ways including the use of ci to monitor changes in community well-being in areas such as unemployment or teen pregnancy rates (ranghelli 2006) . however, one key area in which cfs have increasingly sought to distinguish themselves is in the area of community leadership (cfleads and cfinsights 2017, sacks 2014). within the cf world, community leadership has taken many forms, but has historically been defined along the lines of: contributing actively to community discourse in a way that better informs the community, building strategic connections that help to broker local solutions to pressing problems, cultivating both donor and governmental resources to maximize funding for local solutions, fostering greater efficiency in problem solving by leveraging systems change through such forms as policy advocacy and greater local collaboration, and championing accountability through measuring impact and increased capacity (ballard 2007) . this has often translated into such cf activities as: "convening stakeholders around a common problem or issue; forging partnerships that leverage additional public or private resources; brokering new, fragile or even contentious relationships; providing needed training and technical assistance to nonprofits; speaking out and using the media to raise visibility and spur action on an issue; commissioning research and needs assessments to identify gaps in services; and collaboratively creating new institutions (ranghelli 2006:3) ." community foundation community leadership has also been increasingly seen in the area of supporting collective impact efforts to collaboratively address community problems through coordinated, multi-sector and data driven partnerships (ridzi and doughty 2017; ridzi 2019) . though cfs as a field have experienced increasing market pressures to move into the community leadership space, and have even been the target of public admonishments to lead, engagement has been inconsistent with less than a third engaging in this way (harrow et al. 2016) . this is in part due to wide variation in the proportion of discretionary grant making funds across organizations (which results in discrepancies across cfs in terms of their latitude to direct funds toward contemporary needs) (pavey et al. 2012) . there is also broad interpretation about what is meant by "community leadership" (pavey et al. 2012) . in some cases, it has meant talking a stand to be a force for civility and progress amid political chaos. this is the case with the community foundation for northern ireland, which focused on peace building by gaining the respect of different sectarian constituencies, and with the community foundation for south sinai and the maadi community foundationboth in egyptwhich publicly embraced goals related to revolution (harrow et al. 2016) . in other cases, community leadership has taken the form of efforts to revitalize chronically disadvantaged communities through "embedded philanthropy" and civic engagement (karlström et al. 2009 ). this has been the case with such cfs as the denver foundation and humboldt area foundation in california who have invested heavily in fostering local resident leadership (by funding block parties, neighborhood cleanups and advocacy) and including bipoc representation in economic planning efforts, respectively. in still other cases, such as the london community foundation, community leadership has taken the form of partnering with media (in this case the evening standard news outlet) to launch the dispossessed fund in order to shine a light on issues affecting londoners ranging from food poverty to gang violence to covid-19 (pavey et al. 2012 ; the london community foundation 2020). another approach to community leadership that has won acceptance in the cf world is that of curating and publishing indicators of community well-being, such as the toronto community foundation's vital signs which serves as a platform for advocacy toward improved services and policy change (harrow et al. 2016) . seeking to assert themselves as local community leaders with specialized local knowledge and personalized service (leonard 2014) many cfs have made investments in data infrastructures that reinforce their brand and identity as having a finger on the pulse of community well-being. in taking on this role, is not uncommon for cfs to conduct surveys. for instance, the first cf to come into existence, the cleveland foundation, conducted surveys at its onset related to schools and criminal justice to help set its grantmaking agenda and raise its profile as a leader in the community (sacks 2014) . more recently, in 2012 and 2015, the kalamazoo community foundation surveyed the local community on community issues and philanthropic behavior. 4 in 2016 and 2017, the berkshire taconic community foundation launched a resident survey to assess community needs to give local community members the opportunity to provide perspectives "on key challenges and opportunities for improving lives." 5 similarly, in 2016 the saint paul and minnesota foundation launched the "east metro resident pulse," a vitality survey of three counties that is conducted every two years. 6 lastly, and perhaps most pertinent to this paper, going back to 2006 in canada, the community foundations of canada (cfc) coordinated vital signs reports of existing data (sacks 2014) , to which some foundations elected to add a survey component. the above literature on the ci and cf movements suggest a growing synergy of shared interests in the well-being of the local communities where they serve. their work is mutually advantageous and inherently compatible because they are both "movements" aimed at improving the local communities they serve through participation of local residents. community indicators and cfs furthermore offer the potential to complement each other's work by identifying issues of community concern and matching funding to address them, respectively. furthermore, both movements have been gravitating toward a more intimate knowledge of their communities. in this respect, the synergy between ci and cfs is visible through their mutual interest in local community surveys. to better understand the appeal of this trend, we present two case studies of cfs using ci and local surveys to focus on community engagement. the program context british columbia is canada's westernmost province, and with 5.71 million people, has the country's third highest population (statistics canada). vancouver foundation is canada's largest cf and although named after the city of vancouver, it is a provincial charity. it has been investing in communities since 1943 and through its more than 1800 endowment funds, has distributed more than $1 billion throughout the province to charities in areas such as arts and culture, education, children and youth issues, environment, animal welfare, community health and social development. in addition to being a broad funder, the organization also focuses resources on community-identified initiatives that strengthen residents' connections and engagement in their communities. vancouver foundation works to convene partnerships and conversations around emerging issues, and also through conducting and sharing research. the commitment to learning and sharing knowledge and resources can be seen though its open licensing initiative 7 which allows access to locally relevant and up to date data that can be used by others to identify and address the opportunities, issues and urgent needs related to their work. vancouver foundation began its notable ci work in 2006 with the national launch of vital signs, 8 a program which originated as a project of the toronto community foundation in the late 1990's , and is now coordinated nationally by community foundations of canada (cfc). 9 at the onset, the vital signs initiative was designed to focus on existing research from national, regional, government and non-government sources rather than conducting new research. each report contained ten set issue areas, such as affordability, education and safety, with some cfs adding one or two areas specifically relevant to their community. each issue area was then paired with four to ten indicators (patten and lyons 2009) , with cfc providing cfs with national data sets. on a designated day in the first week of october, participating foundations across canada would collectively launch their local vital signs reports. since its inception, "vital signs has evolved to become more flexible and accessible to a broad range of community foundations" (pole 2015:6) with cfs adapting the format to ensure the best fit for their organization's needs and focus. some have moved away from a comprehensive look at how communities are faring in a range of key quality of life areas in favor of releasing reports focused on a specific issue such as social capital and the creative workforce. other foundations have elected to produce less labor-intensive mini reports or focus strictly on hosting community conversations. most recently, cfc has begun to align national data sets with the un's sustainable development goals (sdgs) which has allowed cfs to measure local canadian data against common indicators as well as in a global context. 10 vital signs reports are designed to provide a comprehensive view of local issues and enhance the ability to make connections between various needs and issues. this allows cfs to work with a wide range of community stakeholders and sectors and is a means by which cfs can fulfill the community leadership aspect of their mission. with vital signs, cfs can play a role of neutral knowledge broker and convener in their community and are uniquely positioned to capitalize on their credibility to shape community discourse and dialogue on local issues (pole 2015) . while cfc provides access to national data sets, many foundations also elect to complement existing data with a perceptions survey component. these surveys are administered locally by the host cf with many focusing on asking residents, or 'citizen graders', to assign a letter grade, or rating, to each issue area as well as identify top priorities that need to be addressed for the issue area. vancouver foundation released its first report in 2006 with a focus on the city of vancouver, an urban area with a population at the time of approximately 578,000 (2006 statistics canada). three additional reports were released in 2007, 2008 and 2010 with an extended reach of metro vancouver, an area with a population of approximately 2.5 million. two special youth issues were released in 2009 and 2013. in 2016, the foundation extended the reach of the report to have a provincial focus. the most recent report, released in october 2019, focused on community participation, 11 and also has a provincial focus. although vancouver foundation's first vital signs report in 2006 relied heavily on secondary data, the foundation identified at the time that there were a number of frustrations with this approach including: not being able to find recent data; finding that necessary data had not been collected for certain areas of interest; discovering that data were not in a useable format; and issues with public accessibility. 12 these frustrations were not isolated to the vancouver foundation. a report published in 2009 on the vital signs program acknowledged the challenge of obtaining sufficient and up-to-date data. as the authors concluded, "ultimately the contents of the reports are circumscribed by what data are available" (patten and lyons 2009:60) . while working with cfc on the foundation's reports, vancouver foundation, in an approach used by other cfs, also collected local data through a research committee. up until the 2010 report, survey data focused on assigning letter grades and identifying key areas for improvement, to provide valuable additional information to the report. in 2016, vancouver foundation expanded its vital signs project to a provincial report to better reflect the foundation's geographic reach and to capture broader trends in communities throughout british columbia. due to the challenges of managing the scope of the project,and finding consistent and timely secondary data for both small and large communities, the decision was made to base the report solely on primary research collected through a survey. working with mustel research group, the survey contained three main areas of focus: 1. community assets, which looked at what people liked best about their community; 2. issue areas, which explored the issues of greatest concern and opportunity for improvement; and 3. sense of belonging and community involvement. in addition, there were 15 demographic questions including income, education, type of home/dwelling, ethnicity, personal family situation and years lived in current community to enable robust cross tabulation for vancouver foundation, and those wishing to use the data. in addition to a research committee of local experts, the process of creating the survey was heavily influenced by input and feedback from other cfs, who were expected to be key users of the data. this process ensured it was relevant to, and representative of, the diversity of the province's communities. co-creation also fostered buy-in, which resulted in the majority of the province's cfs helping to distribute the survey ensuring provincial representation in responses. the survey was completed online by close to 7100 bc residents between june 14th and july 5th, 2016, far surpassing the initial goal of 5000 responses. the final sample was weighted to match statistics canada census data on the basis of gender, age, and region of residence. community foundations across british columbia promoted the survey through websites, social media, email, newspaper advertisements and partnership arrangements. these valuable outreach efforts resulted in regional representation that otherwise would not have been possible. approximately 70% of interviews were collected by mustel group through panels, and 30% by cfs. respondents could complete the survey in english, chinese, or punjabi in an effort to further increase sample representation. to ensure cfs, and other interested parties, were able to view findings for the communities they serve, respondents were asked to identify where they live based on major centers where foundations are located. respondents from smaller surrounding communities were asked to select the center they live closest to. communities were then grouped into 'regional clusters' based predominately on bc health boundaries. 13 syracuse new york is a medium sized city in the united states with a metropolitan statistical area population of around 662,577. it is the largest city in the central new york region. the central new york community foundation is the region's largest charitable resource. established in 1927, it collects contributions from donors, manages them to grow over time and then distributes funding to local charities to help them thrive. with assets of more than $280 million it has invested more than $200 million in community improvement projects since its inception. as a grantmaker, civic leader, convener and sponsor of strategic initiatives, the central new york community foundation strives to strengthen local nonprofits, encourage better understanding of the region, and address the most critical issues of our time. syracuse traces its ci work back to 1997 when a group of citizens began to have community conversations, collect indicators and track progress (ridzi 2017) . this effort evolved in 2011 when the central new york community foundation launched a new version of ci in a website format, cny vitals (ridzi 2017) . today the website consists of two components that highlight key community trends in the areas of poverty, education, health, housing, economy and arts and people (or demographics). the first component is a data visualization engine whose construction and maintenance is contracted out to a firm, which routinely updates the database with publicly available statistics from sources such as the united states census bureau, the department of labor and the state departments of health and education. the second component is a website that takes selected data visualizations from the first web engine and embeds them on a more journalistically focused website that seeks to put a human face on the data available in the visualization engine. while both components are available on the internet and appear as companion websites, the visualization engine has a variety of complex permutations for data display options that are more suited to professional data consumers such as grant writers and program developers. the second, more journalistic website is designed for the general public who is seeking to keep tabs on key community trends and are more receptive to a curated interpretation of what these trends mean for people in their everyday lives and why it should matter to the reader. this ci website is one of many that exist across the united states. it is similar in that the majority of data come from federally created sources that are made publicly available on government websites. while the united states census bureau is a robust and essential national asset, when it comes to local community improvement there were several key shortcomings that led the central new york community foundation to invest in greater local data collection infrastructure. first, was the issue of timeliness. as has been noted in other areas of the literature, the open source, free and easily accessible nature of government data comes with a trade-off of being delayed in its collection and availability. sometimes data that are collected are not available for a year or more afterwards. this makes it very difficult for organizations to use these data for planning to address immediate needs, and also difficult to assess whether any progress is made after local cf funded action is taken. furthermore, the audience for federal data is a national one that is satisfied with local estimates that have large margins of error. while this might be acceptable for communities that want to compare themselves with others across the nation, the error ranges are too large for communities that wish to use these data to measure themselves over time. finally, the questions asked in the data collected by national government entities are uniform across the nation and unresponsive to the nuances of local questions for which community members are seeking answers. it is simply infeasible to expect federal data collection authorities to tweak their surveys and census mechanisms to more precisely probe the issues that are on the minds of today's central new yorkers. overdependence on publicly available data sources was a sense of frustration for residents of the syracuse area. the community was able to identify where they were doing worse than other communities but not able to drill down to the specific sub parts or neighborhoods in the community to see what was going on at a more granular level. as a result, initiatives had major blind spots when it came to trying to deploy such approaches as results based accountability (rba) and data driven decision making (dddm). community leaders realized that, if they did not invest in a more sophisticated community data infrastructure, the majority of their day-to-day work would be conducted within a "black box "because they were unable to observe how things were progressing with data. given the shared desire for more intimate knowledge of the local community among both consumers of ci data and cf leaders, the central new york community foundation took several key steps to invest in a better data infrastructure. the cornerstone of this investment was a local survey that it initiated in 2017. the foundation had been frustrated in the past by making investments using publicly available national data only to be thwarted in its efforts to measure and monitor progress using the same data sets (ridzi 2012) . following investments in new staffing skilled in data analysis and program evaluation, the foundation was able to pilot more rigorous program evaluation of its literacy efforts and furthermore able to document its progress in changing not only the outcomes of program participants, but also neighborhood and community level data improvements (ridzi et al. 2014; singh et al. 2015; ridzi et al. 2016 ). emboldened by this success the foundation sought to build a similar infrastructure that could be used for other future programming and that could both reliably measure the efficacy of foundation grantmaking and empower local grant recipient partners and collective impact peers to achieve a data driven norm for decision-making, collaboration and ongoing refinement of efforts. in collaboration with nonprofit partners participating in a data learning community the cf built a pilot for real time data sharing across organizations that would allow for coordinated, data driven action yet still protect the client confidentiality of all participating organizations (ridzi 2020) . in simple terms, this platform consists of a set of commonly used community need and outcome metrics that were utilized across a series of nonprofit partners. the result was a series of new capabilities that strengthened the capacity of both the ci project and the cf. as with other ci projects internationally, the central new york community foundation and vancouver foundation rely on a variety of sources to produce the data they publish related to community well-being. while statistics collected and distributed by national and local governments are cornerstones of the ci for these foundations, both have also found great advantages to commissioning or administering their own surveys of local community members in order to enhance the insights that government-curated data can provide. among the advantages explored in these two comparative case studies are: increased relevance to local concerns, input from community stakeholders, timeliness, granularity to local geographies and the ability to incorporate local perceptions in telling the story of local communities. each of these advantages are deployed to further the field by better measuring well-being and inspiring action but they do so in a way that is consistent with the broader cf field's aspiration of community leadership (cfleads and cfinsights 2017, sacks 2014 , ballard 2007 , ranghelli 2006 . cfleads (2019) has articulated five key elements of effective community leadership: & "engaging residents to hear their concerns, lift up their ambitions and harness their talents. & working across sectors because the challenges facing communities are multifaceted and inter-connected and cannot be solved by any one entity or sector. & commissioning and disseminating local data and research to help understand the nuances of community challenges and provide information to help solve problems. & shaping public policy, recognizing that government systems have a significant impact on the lives of every resident. & marshalling resources beyond the foundation's own grantsfrom private foundations as well as from local, state and federal governmentto address community needs (p. 1)." as seen in table 1 below, both of the cfs profiled have used local surveys to enhance their community leadership capacity in different areas. in the following sections we explore each initiative's efforts in greater detail so as to demonstrate the multiple ways in which surveys can be deployed to address different leadership goals. both cfs and ci exist in large part to serve the needs of a community's residents. this, however, has not always meant that residents have had a clear voice in the work of these institutions. conducting a community survey can be one strategy for involving those who live within a community and incorporating their perspectives, concerns and ideas. in the case of vancouver foundation, engaging residents can be clearly seen in both the survey and community conversations which take place as a result of (or a precursor to) the report. in 2016, when the report was released, nine british columbia cfs used the survey data and another 11 stated they planned use it the following year either through a report, community conversations or to inform their work. intentionally seeking to harness the talents of local residents, vancouver foundation's open license policy provides opportunities for others to develop ideas, content, products, and services in ways that benefit the community and unlock the full value of resources such as vital signs. the contents of vancouver foundation's 2016 vital signs report were made available under this license, which applies to all of the data and means it can be used for other work, as long as vancouver foundation is credited as the source of the content. to further reinforce that survey data collected by vancouver foundation is intended as a community resource, the 2016 vital signs website was created in a way that allowed data to be easily downloaded and shared in a usable jpeg format. 14 the vital signs survey results have helped vancouver foundation better understand the communities it serves, and in some cases has surfaced new priority areas. a suite of survey questions in 2010 helped to identify belonging as a focus which led to the expansion of a neighborhood grassroots granting program. 15 vancouver foundation's vital signs projects are part of an ongoing commitment to understanding the priorities and experiences of community. it is used to inform and guide work as a funder, partner, and convener, and share it with organizations with the hope that it might create new opportunities from the data and findings. in terms of increased input from community stakeholders, warner (2014) has argued that, "many early community indicator projects were driven by a desire to democratize datato make information more available to the general public (54)." such democratization is two sided in that it can mean both greater access to data and greater input to the focus and design of data collection. for vancouver foundation, the creation of the first provincial survey in 2016 involved extensive input from community stakeholders. there was recognition that based on geography, economic conditions, and urban or rural setting, communities experienced different challenges and opportunities and had different needs in terms of usable data. a draft of the survey was created with input from an advisory committee of community stakeholders and was then shared with all british columbia cfs for their suggestions and revisions. not only did this approach result in a survey more reflective of the province, it served to increase use of the findings. in 2019, when vancouver foundation sought to create a new provincial survey with a target focus on community participation, a decision was made to seek input earlier in the process. a half-day session was held with 50 participants comprised of individuals the foundation had worked with before, as well as those who have never previously engaged with vancouver foundation. from the workshop, four main areas were identified to focus on for the survey questions, along with assistance from the mustel research group, questions were then crafted around the focus areas. they were then tested and revised with feedback and suggestions from staff, british columbia cfs and a research advisory committee. for the central new york community foundation, resident engagement is more of an aspirational goal based on the approach of human centered design (hsd). hsd is an approach to problem solving that keeps the human element of needs and assets at the core of the process and continues to circle back to people to be accountable to solving their problems (harte et al. 2017; bannon 2005) . because the survey collection data platform relies on collecting data directly from the clients of each participating nonprofit, rather than relying on the perspectives of nonprofit staff as had been prevalent in earlier times, the data are based on the real-time experiences of residents. as a result, when it comes time to plan policy or program related responses, participating organizations are equipped with the ability to rapidly identify which of their clients are experiencing specific needs and reach out to these clients to invite them to focus groups or other ways of sharing their personal insights. the result is a framework and infrastructure that facilitates human centered design -an emerging best practice that involves clients in the initial design of programmatic responses to their needs but then continues to engage them as future iterations and refinements to those programming responses are developed. such programming efforts have historically taken shape within specific sectors and are siloed or disconnected from other sectors. for the central new york community foundation, avoiding such disconnects has been an ambition from the launch of the local survey. the idea of working across sectors has been at the heart of the national rise in popularity of collective impact and community coalition work (ridzi and doughty 2017) . inherent in this popularity is the recognition that communities face challenges that are not easy to solve. oftentimes referred to as "wicked" social problems, they are multifaceted and interconnected such that individual sectors (such as schools, healthcare, government etc.) are unable to solve them on their own. this recognition was at the heart of the central new york community foundation's local survey design and launch. in this case, it was a group of community stakeholders who first formulated and piloted the local survey (in collaboration with the central new york community foundation). a member of the adult education roundtable of the literacy coalition of onondaga county shared an intake survey that they used with their clients with the group and this was later refashioned into the survey that was administered across all of the participating members in that roundtable group. this input allowed for a survey that was responsive to the needs of this group and inclusive of their primary concerns such as learning disabilities, educational attainment, and access to educational resources. however, it was also designed to be cross-sector and this has led to its uses as a match making tool across sectors. eventually the survey was adapted across nonprofits from a wide range of sectors ranging from hospitals to early childhood service providers, community centers and antipoverty programs. because organizations were now sharing data in real time, while still protecting confidentiality, a new form of data-facilitated collaboration was possible. the central new york community foundation allowed this network of cross-sector organizations to intentionally seek out opportunities to work across sectors through what came to be referred to as "data dating" (ridzi 2020 ). this was a way for organizations to be much more specific in how they reached out to organizational partners. rather than reaching out based on preconceived notions, organizations could now use data to identify other organizations that either had a shared need so that they could apply for grant funding together or a need that was complementary to an existing asset. for instance, an organization focused on job training could browse the needs of other organizations providing services such as food pantries etc. to find where there were many potential recruits for their programming. this would lead them to reach out to the organizations that were already serving those clients and test the waters for potential collaboration such as opening satellite sites, formalizing client referrals and other ways of rethinking how their different organizations and missions could complement one another. having a local survey has helped the central new york community foundation to tell the stories of its communities not just from their perspectives, but also the perspectives of charities that were increasing their sophistication in the areas of working across sectors. as one shared, "sometimes in syracuse, organizations tend to work in silos and there are not always a lot of opportunities to meet and exchange ideas," one nonprofit survey participant said. "this provides us with an opportunity to all get to the table and examine through data how we can work through problems collectively." because the data collected by each organization were geocoded to census tracts before being anonymized and shared across organizations, the data could then be analyzed according to very granular neighborhood geographies. this allowed for an approach known as "hotspotting" in which key neighborhoods that were experiencing increases in particular needs could be identified and resources could be pulled together across organizations that were serving clients in the same neighborhood that experienced the acute needs. for instance, one neighborhood community center was able to use the data to plan a community day, to bring in agencies that provide services toward the greatest needs reported in their clients' assessments. as they shared, "when we evaluated the data that we and our… partners gathered, it became clear to us that we needed to double down on our food pantries," and "we found that there is a real need for food and personal items within some neighborhoods of the city, and we need to increase our efforts to get funding that will allow us to increase our supplies." as the saying goes, all politics are local. the same can be said about community needs. knowing about current needs is only part of the battle. knowing where they are concentrated is another key point of data. in the words of the nonprofit that planned the community day, "this tool gives us opportunities, especially with live mapping, to identify locations where interventions can be made… such an opportunity to identify unanticipated needs was so powerful and some partners were so surprised by what they found that they ended up using the data for strategic planning". it is not uncommon for people seeking ci data to presume that certain data sets exist and are accessible only to be surprised when they are unable to find such data. publicly available government data only go so far and, as a result, communities trying to address needs that arise from resident concerns find that they are not always able to rely on data to understand the nuances of their community. the provincial survey, managed and funded by vancouver foundation, enabled cfs to use the survey data specific to their region to supplement the work they were already doing and pair it with local secondary data. for some of the smaller foundations, the survey research made it possible for them to take part in the initiative they otherwise would not have been able to. for instance, the sunshine coast community foundation, who had not intended to produce a report in 2016, received such a great response rate from their community, that they decided to publish a four page mini report 16 with key findings from the region. community foundation driven survey findings can serve as a source of free, unbiased research for citizens, local government, businesses and service providers to better understand their community and take action. it is a resource to help mobilize community knowledge and identify community priorities. the survey component of the vancouver foundation work has evolved since the first report in 2006. for the first survey, ipsos reid research firm was commissioned to conduct an omnibus survey with four quality of life questions. in total, a random sample of 240 vancouver residents was polled through a telephone survey. this was combined with an online perceptions survey where close to 200 informed citizens, comprised of civic, nonprofit and business leaders, were asked to assign a letter grade and identify top priorities for the issue areas. although the response rate increased in 2007 and 2008, when the report changed its reach to the larger metro vancouver area, the approach remained the same with a random quality of life phone survey and a targeted online survey for citizen graders. in 2010 the approach was simplified to have one comprehensive survey, conducted online, which included quality of life questions, grading for the issue areas and identification of top ways to improve the issue areas. the survey was distributed through environics research to their panels and received almost 1200 responses. in 2016, the foundation had a desire to expand beyond metro vancouver to a provincial survey. the reason for this was to provide a resource for the other 53 cfs around bc to help with their vital signs projects. although cfc provides access to existing supporting data, primary research is time consuming and expensive to collect, so by acting as a data collection point for the province, the information could be shared widely to provincial cfs to reduce costs and avoid duplication of effort. by taking this approach, vancouver foundation would be able to provide communities around the province with data tables for their area which could then be incorporated into, or used to supplement, vital signs projects. a second rationale was that, as a provincial funder, it was a way to better understand the communities served and to learn about regional differences, similarities, issues, and opportunities. the creation of a provincial survey allowed vancouver foundation to provide regional and local data to all cfs in british columbia. this was an important shift as it enabled cfs at a local level to use primary research in their own vital signs projects to tell the story of their community, which could then be paired with national data provided by cfc, or local sources such as libraries, municipalities or post-secondary institutions. any community with a minimum response rate of 100 received the data tables for their area. in total, 22 communities achieved this number. sixteen regional reports were also created, based geographically off the health regions in the province. the expectation that each community collect a minimum of 100 surveys highlights a principle of "sweat equity" such that participants feel that knowledge and resource sharing are not one-sided. in the case of the central new york community foundation, participating organizations were also required to collect 100 surveys before they were granted access to the data collected by other participating organizations. in both cases this expectation of sweat equity helped to fuel a larger network of data sharing that has the potential to inform communities about localized needs as they fit into a larger community context. this expectation of sweat equity as a form of positive peer pressure to collect data for the common good also highlights the lack of available data for the community and the niche that cfs can play by commissioning, championing and spearheading local data collection. timeliness is a key part of the value added of commissioning data collection. vancouver foundation launches its survey in late spring/early summer for the years it produces a vital signs report. the report is released the first week in october and community conversations often take place within six months of the release of the data. this increases the confidence of those consuming and using that data on current perceptions and actions of residents. a key way that cfs can fulfill their leadership role is through convening and facilitating knowledge sharing. however, with limited time and resources, this can present a challenge for many looking to engage in this work. vancouver foundation was able to support capacity in this area by customizing tool kits of resources and data for use by the cfs in british columbia. a starting place for this work was hosting webinars and creating a document to help the foundations understand how to interpret the survey data, and further how it could be used. to assist further, community conversations toolkits were created. these were intended to allow cfs to use their local knowledge and connections to focus on the issues of most importance to them, while minimizing the time and effort required to host the events. the kits included: posters and social media promotional templates; customized data sheets for the area; conversation worksheets which included local data specific to the topics selected by the community, signage, copies of the report, and an event guide book. foundations were also given a small grant to help with the costs of rental space, catering and audiovisual equipment. squamish community foundation was one of the foundations that utilized the toolkit to host a community conversation. the conversation was held in the spring with the goals for the event including a discussion on areas of concern, evoking positive change, and enriching the quality of life for squamish residents (green 2017) . information from the event was then used to help inform direction for their vital signs report which was set to release in october 2017. the capacity crowd at the event included the mayor and local experts who moderated the table discussions on key concerns such as housing and youth engagement. basing the conversations around the survey findings for the area was highly valuable for the community as it enabled a data-centered discussion rather than speculation on top resident concerns. in the case of the central new york community foundation, data sharing is done more on the network level (i.e. organizations that participate in the survey are able to see each other's data but those outside of this group do not have access). for these groups, timeliness and specificity to their clients' needs are paramount. previous experiences with long delayed data have haunted the central new york community and made it challenging to feel as though community efforts were responding to the here and now, rather than to last year's problems that we were just hearing about now. the difference was quite noticeable once the survey was launched. several nonprofits, as well as the central new york community foundation, noted increasing need in such things as food insecurity in real time and had conversations about these internally before talking about potentially collaborating to take action. by the time such groups connected they were already thinking about what other organizations to reach out to for collaboration. community foundation and ci initiatives are both often quite aware that they cannot solve the social problems they focus on by themselves. in the case of ci projects, there is a realization that the major goal is to identify and bring awareness to community needs, and then to hand off the work of addressing those needs to other community actors. for cfs, the role may include identifying funding needs and raising awareness but then extend into funding pilot projects and collaborations or collective impact coalitions to work on addressing those needs. however, even in these cases there is an awareness that foundation resources are limited and insufficient to address wicked social problems without the involvement of government. governments have access to a variety of data sources that ci projects and cfs do not. however, the form and format of these data are typically mandated by federal and state/ provincial source so governments, even local governments, seldom have time to explore the nuances of local needs through conducting local surveys. in the case of the central new york community foundation, the local survey helped to bolster efforts to shape public policy pertaining to lead poisoning. the central new york community foundation run ci project (cny vitals) revealed that lead exposure among children was three times higher in the county as compared to neighboring counties. however, these publicly available data were several years delayed in being released and they were not nuanced enough to understand the dynamics behind this problem. after reviewing more recent administrative data on lead exposure, the local survey being administered was able to probe deeper by asking about whether people had their homes or children tested for the presence of lead. noting a high proportion of families indicating that they were not being tested and noting this was increasing in real time provided confidence that this was a problem that was far from solved. furthermore, it was of a magnitude that could not be addressed with limited cf funding. as a result, the foundation took a role in actively supporting policy change in the form of a city ordinance to make testing for the presence of lead a requirement for rental apartments. this would solve the problem of people not having their homes tested. with the passing of this ordinance on july 13, 2020 this change in government systems promises to have an impact on the lives of residents that will extend far beyond the limited resources at the disposal of the foundation. in addition to directly advocating for government policy change, ci and cfs can leverage local surveys to address the systems by which governments get their work done. government systems involve both formal government and the many nonprofits they contract with to carry out direct service delivery. in the case of the central new york community foundation's work in syracuse, a close dialogue with the city about lead exposure and what to do once lead was discovered revealed that there was a dearth of local contractors that were trained in safe renovation practices in buildings that contain lead (potentially resulting in them making the problem worse by spreading contaminants in the midst of renovation). pairing the survey with collaborative relations in this way helped to reinforce that there was a real time need and encouraged collaboration and mutually supportive relationships that offered momentum as the city and county successfully applied for over $9 million in federal u.s. department of housing and urban development (hud) funding. the work of foundations in this arena can be less visible and more behind the scenes. this does not mean it is not impactful. this is indeed the case in syracuse since federal officials shared that the foundation's work on bringing attention to this area and committing funding was influential in the federal government's decision to provide funding. the ability to help attract funding brings into focus the critical work of marshaling resources that we discuss in the following section. attracting funding to the community to address community needs is only half the battle. strategizing a plan, orchestrating that plan, and tracking progress involve critical components of follow through and can leverage local surveys. marshalling involves the steps taken to "bring people or things together and organize them so that they can be used in an effective way" including work to "organize information or ideas." 17 in the case of the central new york community foundation, using a local survey has been helpful in marshalling resources around dealing with concentrated poverty by providing insights into community conditions and the success in addressing them. as a community, residents were actively discussing a report that had ranked the community as among the worst in the united states for concentrated poverty. while this alone was sufficient to create robust civic discussion, the community lacked data that allowed for probing the different dimensions of this local concern. poverty is an abstract concept. once addressed in the local survey that was created, however, it was possible to break the experience of poverty down into a variety of categories including housing, transportation, healthcare, clothing etc. being able to focus on this area of local concern also helped the foundation to feel more confident in its grant making and more responsive to the nuances of local need. as sirgy (2018) has asserted, ci projects can take a variety of different value propositions ranging from focusing on sustainability and social cohesion, to social inclusion and empowerment. in this case another of the dimensions he notes, socio-economic security, took first priority. having a local survey also helped the community to take a results based accountability (rba) approach to handling the over $30 million in state funding that it successfully attracted to deal with poverty. while the central new york community foundation, and key partners such as the county government, had been interested in pursuing rba, program evaluation level data that could be combined across programs to monitor population level change was difficult to come by. as a result of this new local survey, administered continuously and online, a new source of data emerged that could be aggregated and could then be used to anticipate changes in other more longterm indicators. in one example, programs that received state anti-poverty funding were expected to have their clients complete the local community survey to both notice trends across clients of different organizations (i.e. declining unmet needs is a positive indicator along the pathway out of poverty) and notice opportunities for cross sector collaboration (as described above). in another instance, organizations that received funding were required to keep track of the people they served and to identify them by geographical location (census tract). this resulted in the ability to conduct program evaluation in new and innovative ways that were consistent with rba. for instance, one organization reported significant numbers of clients who were provided transportation services in a select group of census tracts. it was then possible to examine surveys collected in the targeted census tracts and monitor as the reported need for transportation declined. the experiences of the vancouver foundation and the central new york community foundation offer insights for other cfs that are considering investments in local surveys as part of a ci and community leadership strategy. specifically, such surveys offer a tool for conversations and coordination that can help a cf strengthen their portfolio in any of the five key elements of effective community leadership that cfleads (2019) has identified. when it comes to engaging residents, both examples offer helpful insights in their differing approaches. the vancouver foundation targeted the community at large through publically disseminated surveys and this has helped them emerge with a general sense of the opportunities and concerns of citizens across all walks of life. however, this approach is most likely to miss the dispossessed and hardest to reach citizens who most lack a voice. that is precisely the population with which the central new york community foundation sought to connect. in their case, residents had to be a client of organizations that tended to serve those in greatest need in the community. community foundations seeking to engage residents would do well to be clear at the outset about what parts of the population they are seeking to engage. when it comes to working across sectors, surveys can be effective at identifying what sectors should be involved and at gauging the relative magnitude of sentiments and needs. the central new york community foundation began with a mature survey from the human services sector which allowed it to assess the prevalence of multifaceted needs that the human services sector had already established were present (for instance the survey did not just ask about poverty but about the multiple dimensions of poverty). in addition, in order to enable cross-sector collaboration, organizations had to buy in to conducting surveys in which the majority of questions did not pertain to the services they offered (although they were welcome to augment the survey with such questions). only by asking residents about the needs that their services do not provide for could they learn what other sectors they needed to coordinate with. both foundations offer instructive lessons when it comes to commissioning and disseminating local data and research to elucidate the nuances of problems. neither foundation is yet fully leveraging local surveys to the full capacity of addressing all five community leadership components. this is partly a function of time; these communities may eventually evolve to utilizing local surveys to bolster their portfolios in all five elements. it is also a function of the fact the local surveys incur costs that must be balanced with the realities of finite resources. these include not only the costs of doing the survey work itself, but the time and resources needed to deal with the complexity of coordination with partner stakeholders. in recognition of the high cost of conducting surveys, the vancouver foundation views funding a provincial survey as one of the ways it can support and help build the capacity of other cfs in the province to take on their own data based projects. while the central new york community foundation supports nonprofits in administering their own surveys, this is not without its own cost to staff time. however, because it aligns with strategic plan goals (i.e. capacity building efforts among nonprofits), much of this work is done in a collaborative learning community setting with nonprofits focused on improving performance management skills, which helps to justify the use of staff time. when it comes to the complexity of coordination with partner stakeholders, vancouver foundation has found that those aged 18-24 can be a challenging group to reach for survey participation. in order to achieve a representative sample for vancouver foundation's 2019 provincial survey, social media boosts were purchased for facebook and instagram, extra outreach efforts were conducted with youth serving organizations to distribute the survey and an additional youth panel was accessed through mustel research group. province-wide representation would not have been possible strictly through typical research panels which tend to have representation from the larger centers. outreach by cfs in the province helped to address this issue. taken together, this enterprise, like many community initiatives, moves at the speed of trust. for both communities, the survey efforts started small and began to grow in the fashion of a snowball as they gained momentum over time. in the area of shaping public policy, local surveys can be very helpful as the source material for public policy advocacy, white papers and complex policy discussions. the added specificity and real-time nature can also provide assurances that the foundation is directing its advocacy at the optimal policy levers that will address community needs or build on strengths and talents. finally, surveys can help with marshalling resources because they offer a specificity about community issues that is not often available in publically collected data. just as importantly, they offer moveable numerical targets (such as the percent of respondents that report a specific need such as transportation) that donors and other partners can all unite their resources around. focus on the creation and use of local surveys highlights some of the key synergies between the ci and cf movements. it also helps to add new perspective to the already interdisciplinary study of community well-being. the cf and ci movements intersect and find synergies in their shared love of place and passion for location. but beyond their shared interest in the local communities where they are anchored, they both seek community engagement through conversations and better coordination among local stakeholders. it is in service to this ideal that we see such strategies as resident engagement, commissioning data collection, data dating and co-creation of shared metrics to facilitate collective impact and results-based accountability. coordinated ci projects and cfs serve to raise each other's profiles and mutually reinforce each other's missions. furthermore, they have a symbiotic relationship in that ci's address the cf need for community knowledge to invest in projects focused on well-being while cf's offer a steady source of funding for cis. both ci projects and cfs see mission overlaps when it comes to striving for expertise in the areas of: 1-knowing the community, 2-long-term focus and 3-results driven learning organizations that seek to evaluate impact. as mazany and perry (2014) point out, cfs are increasingly carving out their market niche in relation to their specialized local knowledge and personalized service. when comparing them to other philanthropic mechanisms, the distinguishing factor of cfs is in knowing the community (cfleads 2013). community foundations tend to be results-driven learning organizations that seek to engage in and evaluate the impact of their community leadership work (cf leads 2013:3). in this article we have explored this within the framework that cfleads (2019) has articulated around the five key elements of effective community leadership. we have focused on how the two cfs studied have leveraged a local survey component to their ci work in order to improve their competency for these elements. specifically, we explored how a local survey can foster better engagement with residents around their concerns and the ways their ambitions and talents can point us toward solutions. we have seen how surveys can enable the service delivery community to work across sectors and we have seen how surveys can position foundations to originate and disseminate local data that can provide insights into the nuances of community challenges. all of this work empowers cfs to have a confident voice and to speak up in the service of shaping public policy; and more strategically to help in marshaling local resources. as slutsky and hurwitz (2014) assert, "community foundations raise the patient capital that allows them to stick with issues, even difficult ones, over the long haul. entrenched poverty and environmental degradation will not be solved during our lifetimes. fixing the schools, creating jobs for all who need them, and reforming healthcare will take years of hard work and perseveranceand reliable, patient capital. it's no accident that philanthropy often focuses on "intractable" problems (p. 85)." by focusing on identifying and then deepening understanding of such social problems through local surveys, cfs and ci strategically invest in detailed knowledge that can empower the communities they serve to take data driven action. they further reinforce the nexus of their missions by strengthening the leadership roles they play in monitoring and improving community well-being. data availability not applicable. conflict of interest 'not applicable'. code availability 'not applicable'. community foundations and community leadership a human-centred perspective on interaction design created by the national task force on community leadership prepared by cfleads and aspen institute community strategies group elements of effective community leadership assessing community foundation needs and envisioning the future dimensions of the field: an in-depth analysis of the community foundation movement connecting the dots with conversation: squamish will discuss areas of passion and concern community foundations: agility in the duality of foundation and community. the routledge companion to philanthropy a human-centered design methodology to enhance the usability, human factors, and user experience of connected health systems: a three-phase methodology embedded philanthropy and the pursuit of civic engagement modeling community well-being: a multi-dimensional approach economy doesn't buy community wellbeing: a study of factors shaping community wellbeing in south korea merging money and mission: becoming our community's development office here for good community foundations and the challenges of the 21st century here for good community foundations and the challenges of the 21st century vital signs: connecting community needs to community philanthropy in canada. the philanthropist the role of community foundations in the big society: taken for granted ensuring there is "community" in the community foundation here for good community foundations and the challenges of the 21st century knowledge as leadership, belonging as community: how canadian community foundations are using vital signs for social change vital signs: an exploratory case study of community foundations' local collaboration in a national program context measuring community foundations' impact. nonprofit sector research fund working paper series managing expectations when measuring philanthropic impact: a framework based on experience community indicators and the collective goods criterion for impact collective action, collective impact and community foundations: the emerging role of local institution building in an era of globalization and declining social safety nets goldilocks data-connecting community indicators to program evaluation and everything in between does collective impact work? what literacy coalitions tell us the imagination library program: increasing parental reading through book distribution the imagination library program and kindergarten readiness: evaluating the impact of monthly book distribution community quality-of-life indicators: best cases viii community foundations: symposium on a global movement-current issues for the global community foundation movement informed by knowledge shared and lessons learned. worldwide initiatives for grantmaker support (wings) the growing importance of community foundations. indianapolis: indiana university lilly family school of philanthropy retrieved on exploring the literacy practices of refugee families enrolled in a book distribution program and an intergenerational family literacy program what types of indicators should be used to capture community well-being comprehensively? int here for good community foundations and the challenges of the 21st century indicators and community well-being: exploring a relational framework evening standard dispossessed fund building philanthropic and social capital: the work of community foundations in federal reserve bank of san francisco & the urban institute (authors) publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations he is a past president of the literacy funders network, an affinity group of the council on foundations. frank holds a masters degree in public administration and a ph.d. in sociology from syracuse university's maxwell school. he also carries a certificate of advanced study in women's studies. prior to joining the community foundation vital signs reports, as well as the 2017 connect & engage report. prior to joining vancouver foundation, trina worked for 10 years at bc children's hospital as an educator for the injury prevention program before transitioning into fundraising at the foundation. she is currently the director of partnerships and engagement at minerva bc. she holds a master of philanthropy and nonprofit leadership from carleton university in ottawa, canada, as well as a graduate diploma in social innovation from the university of waterloo and a ba in communication from simon fraser university key: cord-016935-0wyl2h62 authors: appanna, vasu d. title: dysbiosis, probiotics, and prebiotics: in diseases and health date: 2018-02-06 journal: human microbes the power within doi: 10.1007/978-981-10-7684-8_3 sha: doc_id: 16935 cord_uid: 0wyl2h62 the microbiome like any other components of the body undergoes numerous challenges during the life-span of a human being. these complications may involve injuries, aggression by pathogens, pollution, hormonal variations, genetic pre-disposition, unbalanced nutrition and onset of diseases. although the microbial reconfiguration provoked by these stressors are not immediately evident as in the case of an afflicted visible organ where the abnormality is readily observable, the biological perturbations induced manifest themselves in form of various illnesses. the disruption of a working microbiome is referred to as dysbiosis and is a condition whereby the fine balance between the microbial communities and the host is distressed. diseases such as cancer, irritable bowel syndrome, rheumatoid arthritis, acne, gastric ulcers, obesity and hypertension can ensue. the pathogeneses of some pulmonary disorders, digestive complications and neurological abnormalities can be traced to the imbalance in the constituents of the microbiome. however, rebiosis, the re-establishment of the native microbiota is proving to be an excellent remedy against this condition. probiotics, prebiotics, and synbiotics are potent therapeutic tools designed to rectify this situation. probiotics such as lactobacillus spp are more or less like stem cells utilized to replenish and rejuvenate the microbiome while prebiotics like fructose oligosaccharides (fos) are microbiome fertilizers akin to mineral supplements or energy nutrients aimed at promoting the proliferation of select microbes in the invisible organ. synbiotics is a combination of both probiotics and prebiotics in a proper dosage aimed at remedying dysbiosis. the molecular understanding of dysbiosis and rebiosis will offer a very effective non-invasive means in preventing and curing diseases with probiotics and prebiotics. this will have a dramatic impact on our well-being. abnormalities can be traced to the imbalance in the constituents of the microbiome. however, rebiosis, the re-establishment of the native microbiota is proving to be an excellent remedy against this condition. probiotics, prebiotics, and synbiotics are potent therapeutic tools designed to rectify this situation. probiotics such as lactobacillus spp are more or less like stem cells utilized to replenish and rejuvenate the microbiome while prebiotics like fructose oligosaccharides (fos) are microbiome fertilizers akin to mineral supplements or energy nutrients aimed at promoting the proliferation of select microbes in the invisible organ. synbiotics is a combination of both probiotics and prebiotics in a proper dosage aimed at remedying dysbiosis. the molecular understanding of dysbiosis and rebiosis will offer a very effective non-invasive means in preventing and curing diseases with probiotics and prebiotics. this will have a dramatic impact on our well-being. keywords microbial imbalance · antibiotics · cancer · obesity · anti-oxidant · drug activation as our microbiome accomplishes a variety of critical tasks for us, it is clear that we will not be the way we are without the microbes inhabiting in and on our body. without this microscopic support, our anatomical constituents and our diet would have been completely different. the diets of carnivores and herbivores are also dependent on the microbial helpers these animals possess. the cows we see grazing would not be engaging in such an activity if it was not for the microbeladen stomach they have. indeed, humans also have evolved to be reliant on microbes to carry numerous functions they are not able to execute without the assistance of their traditional organs. without the presence of these microbes, human anatomy and physiology would have been entirely different; we would not have been biologically the way we are. thus, it is not surprising that if this harmonious relationship is perturbed, major complications may arise with disastrous consequences to the bodily operation. in fact, the delicate balance among the microbial ecosystems needs to be preserved if the body is to function normally. the metabolically compatible members of this community work in harmony and as they are assigned a specific job that enables the community to function properly. this synergy breeds inter-dependence and a specialization of functions. the community forges a collective work ethic amongst all the stake-holders. constant interspecies communication ensures that their activity is controlled and excessive growth is under check. however, perturbation of this fine microbial-balancing act can result in debilitating impact on the host. the increase in some bacterial species with the concomitant decrease of others triggers abnormal signals that can be the harbingers of diseases. this situation is similar to the operation of our social communities. for instance, if there is an excessive amount of doctors and limited number of nurses and other health professionals, the medical delivery system becomes sick. the disruption in the microbial community is bound to create a shift in the families, genera or species of the resident microbes. this can be fatal or make the business of living unpleasant. numerous diseases are known to be triggered by the disturbance of microbial population within the body. the imbalance of the microbiome is referred to as dysbiosis (fig. 3.1) . diet, physical stress, exercise, psychological distress, radiation, flying, humidity, geographical location, age and medications including antibiotics have been shown to exert demonstrable change in the microbial landscape in the body. for instance, ampicillin utilization leads to a sharp decrease in the gut microbiome, while the antibiotic, cefoxilin perturbs the fine balance by promoting the proliferation of clostridium difficile at the expense of other microbes. the amount of some lactobacillus species is sharply diminished during flight and may lead to anxiety associated with air travel. the increased levels of catecholamine produced during stress trigger the growth of pathogenic microbes like e.coli and impede the proliferation of good microbes like lactobacillus and bifidobacteria. farm workers who are exposed to pesticides suffer a similar diminution in lactobacillus and bifidobacteria. exposure to metal pollution like cadmium limits the amount of micro-organisms belonging to the family of bacteriodes that in turn is reflected in reduction of metabolites like scfa (shortchain fatty acids), contributors to numerous pivotal functions in the body as we have seen before. these changes lead to various abnormalities ( fig. 3 .2). the skin is the primary contact with the external environment and is constantly exposed to a variety of fluctuating conditions that affect the microbial communities residing on it. humidity, temperature, clothing, cosmetics, soaps, age, and personal hygiene are some of disruptors of the skin microbiome leading to the onset of various abnormalities (box. 3.1). acne is a common skin complication that afflicts primarily adolescents. during puberty there is a major change in the landscape of the skin with the increase of hair follicles and the maturation of the pilosebaceous glands. these oil-producing vesicles enrich the nutritional content of the skin and trigger the proliferation of oil-loving microbe like the propionibacterium acnes. these microbes secrete lipases and proteins that enable them to gobble oil. unfortunately, these molecular scissors also bruise the tissues adjoining the oily glands. such an unintended assault compels the body to unleash its own guards to defend itself, with devastating outcome. this counter response to the shift in microbial population results in the formation of those unwelcomed blemishes on the face. hormonal imbalance may also aggravate this problem (fig. 3. 3). the dermal microbiota is prone to disruption by a wide variety of factors as it is permanently exposed to the external environment. geography, pollution, ultraviolet radiation (uv-r), occupation and the host biology are major contributors to the skin microbiome. injury, chronic conditions, infection, cosmetics and the use of hygiene products may result in a shift in the bacterial communities. uv-r promotes the release of anti-microbial peptides that may block the body's immune system and creates an environment for the cancer-causing viruses to flourish. chemicals like triclosan, a common ingredient in household products like soap and toothpaste can perturb the fine microbial balance. this is further compounded by the inherent diverse landscape that the skin offers; the face is oily, hairy and exposed to environment while the axilla is occluded, moist and laden with microbial nutrients. the dysbiosis triggered by the host of environmental and microbial-driven features are at the origin of numerous skin diseases. for instance, the atopic dermatitis that is a chronic pruritic inflammatory disorder is characterized by an overwhelming increase in staphylococcus aureus. a decrease in filaggrin, a microbial sensing protein coupled with a decrease in dermicidin, a peptide defending bacterial invasion results in this lack of microbial diversity and the proliferation of a select few microbes. prebiotics like fucosylated oligosaccharides derived from chicory roots and probiotics like staphylococcus epidermis are being introduced in cream to fight dermal dysbiosis. eczema is another common skin ailment that finds its origin in the imbalance of the dermal microbial community. it is a chronic, recurring skin disorder that is more prevalent in children compared to adults. this disease is characterized by a major shift in the microbial population resulting in diminished biodiversity. such a situation promotes the unchecked growth of the microbe, staphylococcus aureus. increased colonization by this organism provides a fertile landscape for the nasty streptococcus to proliferate. the tight-knit functional community is unraveled. the new uncontrolled colonizers secrete toxins that induce the degranulation of the dermal mast cells and force the body's immune system to respond. this change in landscape is partly responsible for the dry red spots that are characteristic of eczema. these patches are sometimes accompanied by local inflammation. in the case of psoriasis, a disease that is prevalent world-wide, similar conditions conspire to create a dramatic shift in the harmonious microbial population. the ensuing diminished biodiversity propelled by the over-representation of the genera staphylococcus belonging to the firmicutes family automatically leads to a reduction in other family members that had bonded into this dermal community and learnt to live in harmony. in this instance, the territorial presence of members belonging to the acetinobacteria family is restrained. thus, begins the initiation of psoriasis. environmental factors like temperature, humidity or presence of cosmetics on our skin may hasten the onset and the severity of this malady. the establishment of the unbalanced microbial community residing in the psoriatic lesions generate antimicrobial peptides and other modulators that hyper-activate the body's immune system. this reaction modifies the life-cycle of the skin cells that respond by growing rapidly, a situation culminating in itchy, dry, red plaques. these become the hub of other uncontrolled microbial activity and can aggravate into psoriatic arthritis. wound healing in diabetic patients is a problem as cuts on the skin of these individuals take unusually longer time to repair. here again the inability to effectively recover from wounds is again due to the uncontrolled proliferation of certain microbes at the expense of others. the sugary environment provided by the diabetic blood and the presence of other nutrients create an ideal ecosystem for the multiplication of staphylococcus. this nutrient-rich landscape on the skin-cut acts as a magnet for some bacteria and disrupts the harmony among the otherwise orderly community members. this microbial imbalance is a recipe for disaster and opens the body for invasion as some of our trusted partners are either too small in numbers to make any difference or are completely wipe-out of our intimate landscape by the opportunistic intruders. and wound healing becomes a very abnormal exercise for the body to partake in the absence of some of the invisible allies. the mouth is another part of the body that lends itself to constant contact with the invisible world. as it is an extension of our environment, the microbial traffic is high. anytime we open our mouth to eat, drink, laugh, smile, yawn or cry, we are enabling millions of microbes to access our body. however, due to the vigilant watch of resident oral microbes and their anti-microbial components, only a select few can contemplate to occupy a piece of the real estate either in our mouth or lungs. the microbial communities composed of diverse constituents that set foot are scrupulously and carefully interrogated by our molecular sentinels. interactions with prospective residents are permitted only if they work for a common purpose. only when a member can contribute to a specific function that the community depends on, the microbial member is accepted and a shelter is made available. the contribution of each of the member is critical for the functioning of the community. however, this situation can rapidly change specially in the mouth where there is a constant flux of diverse exchanges occurring with respect to microorganisms. furthermore the buccal chemical landscape also undergoes tremendous fluctuation due to the regular intake of foods and drinks. this situation can be complicated if one allows any food component to remain in the mouth for too long. carbohydrate-rich nutrients become easy prey on which some opportunistic microbes can thrive. despite the vulnerability of the mouth to possible invisible intruders, the microbial population is kept in check by the watchful guard of other community members including the host. for instance, in the establishment of dental caries, the streptococcus mutans utilizes these sugary goodies stuck on the tooth to produce lactic acid, an event that increases the acidity of the buccal ecosystem. this presents an opportune situation for other microbes like the veillonella and lactobacillus salivarus/acidophilus to colonize this territory and further aggravate the affliction on the tooth (fig. 3.4) . the fine microbial balance that is perturbed as a result of ensuing chemical change in the mouth is an ongoing concern for people especially children with poor dental hygiene. this disruption and the resulting medical complication can be averted by controlling the chemical landscape in the mouth. halitosis is also caused by microbial disruption that results in the increase in h 2 s, a molecule responsible for smelly breath. this may also be aggravated by the genetic make-up of the host (fig. 3 .5). the perturbation of controlled microbial growth in the oral cavity is known to trigger the gum disease referred to as periodontics. the homeostatic equilibrium in the microbial community for a healthy gum is maintained partly by the body's own immune system. this is upset by the invasion and colonization of porphyromonas gingivalis, a microbe responsible for the destruction of gum tissues. these degraded components create a nutrient-rich environment that becomes a breeding ground for other opportunistic organisms that are usually kept at bay by our oral microbiome and the lack of appropriate nourishments they can thrive on. this feeding frenzy results in the overpopulation of some species compared to others and give rise to a misfit community of microbes. bacteria such as prevotella and desulfobulbus are two culprits that exploit this situation and assist in the task of invading the gum. thus, dysbiosis an uncontrolled microbial proliferation resulting from the temporary nutritional change in the oral ecosystem is at the root cause of numerous complications that ache both the hard and soft components belonging to this part of the body. the lack of microbial biodiversity in the crypts of the soft tissue like the tongue is at the origin of halitosis, an affliction that emanates unpleasant smell that most of us find repulsive (box 3.2). the mouth has the second most diverse microbiota in the body with over 700 species. the chemical landscape of the saliva plays an important role in the establishment of the microbial communities that reside in the buccal (continued) box 3.2 salivary microbiome and its health impact (continued) cavity. nearly 10 8 microorganisms are found in one milliliter of saliva, a fluid rich in proteins, lipids, carbohydrates and enzymes. the presence of lactoferrin, lysozyme and lactoperoxidase act in concert to dissuade the colonization by fortuitous bacteria. hydrogen peroxide, hypothiocyanite and nitric oxide derived from nitrate in foods are potent antimicrobial and are part of the defense armoury deployed to fend against cariogenic intruders. however, poor hygiene, nutritional habits, smoking and diseases like diabetes tend to weaken this defense. the presence of increased glucose level generates acidic metabolites that drop the ph of the mouth from 7.0 to 4.0. this promotes the acid tolerant microbe like staphylococcus mutans and results in an increase in the firmicutes family coupled with a decrease in the bacteriodetes family. the solubilization of calcium and phosphate is preceded by a variety of dental diseases. furthermore, the dysbiosis created by this situation leads to reduction of nitrate reducing bacteria, a situation restricting the output of nitric oxide, no. this has major health impact including cardiovascular complications. the use of chlorhexidine containing mouthwash also has a negative influence on no-producing bacteria. hence, the saliva and its microbial residents are an important contributor to a healthy outcome. the mouth and the nostrils are constantly providing the lungs the air we need to live. without this obligatory and mundane routine we will not be able to produce energy (atp) that keeps our body machine active. this process is hard-wired in our brain that we keep on doing until we are no more alive. thus we are constantly exposed to the microbes and chemicals in the environment where we are studying, sleeping, playing, working or just relaxing. the lungs are permanently bombarded with the myriad of micro-organisms our surroundings have to offer. although the microbial populations in the lungs are well-maintained, these communities can be harassed by medications we ingest and by the chemicals in the air we are surrounded by. farmer workers, employees in factories and other industrial organizations are at high risk in this regard as they are surrounded by chemical constituents that affect the microbial composition of the lungs. the development of asthma is triggered by the decrease in the diversity of the pulmonary microbial ecosystem. the release of nutrient-rich mucus during lung infection aimed at arresting the proliferation of intruders can also inadvertently act as a magnet for some opportunistic microbes that further compound the problem. a shift in the microbial community favouring a group of lactobacillus is observed during the onset of chronic obstructive pulmonary disease (copd). during cystic fibrosis (cf) the viscous sputum allows the rapid growth of pseudomonas aeruginosa, a microbe that is controlled in non-cf lungs. this microbial imbalance generates chemicals like alginate that further aggravates the situation. the nearly unimpeded pathway of the air tract between the mouth, lungs and the environment render these organs an easy target of dysbiosis. these body parts are challenged on an ongoing basis with changing microbial population and environmental factors such as chemicals and gaseous pollutants that make them a fertile ground for microbial disharmony. hence, it is critical that the crevices in the mouth do not have nutrients stuck for long as these are perfect ingredients that can dislodge the well-established functional microbial communities and inflict us with diseases. the mouth and nose gears are a common sight in cities around the world with high level of pollution. in beijing, new-delhi and mexico city, citizens are often seen wearing these protective screens in an effort to limit the intake of the polluted air in order to diminish its influence on the lung microbiome. during outbreaks of microbial diseases such as severe acute respiratory syndrome (sars) or influenza, this phenomenon is observed around the globe in order to ensure that the lungs are not further burdened by air loaded with viruses as these will undoubtedly promote dysbiosis. the mouth and lungs are the first line of defence to combat the growth of opportunistic microbes lurking around in the air. thus, oral hygiene and the quality of air one breathes in will go a long way in helping maintain the proper microbial balance required for a healthy body. however, if these conditions are not met, microbial disruption resulting from the reduction of biodiversity in the pulmonary and oral landscape can be a cause of concern. it is not surprising that the deteriorating quality of the air across the planet has led to sharp rise in asthma and other lung-related illnesses ( fig. 3 .6, box 3.3). rheumatoid arthritis (ra) is a debilitating autoimmune disorder associated with the inflammation of the joints that can lead to bone erosion and deformity. the hyperactive immune response can also damage other parts of the body like the eyes, lungs and skin. this dysregulation of the immune system triggers pro-inflammatory tendencies with an increase in t-lymphocytes and self-reactive antibodies. although genetic factors may contribute to this disorder, a major shift in the constituents of the microbiome is observed in ra patients. there is an overrepresentation in the provetella species including provetella copri, an increase in clostridium spp and a reduction in bacteriodes spp. this dysbiosis evokes the elevated production of homocysteine, hydrogen sulphide and lipopolyssacharide (lps) that all known to promote inflammation, a feature culminating in the attack of one's own body part. probiotics like lactobacillus casei has been shown to mitigate symptoms associated with ra. asthma is another inflammatory disease where the respiratory airways are challenged by the aggressive action of the immune system. there is an overproduction of mucus and an intense remodeling of the airway wall ensues. the presence of dust, pollen and spores tend to aggravate this situation. however, this disease is characterized by a marked change in the lung microbiota. in children there is reduction in such microbes as the faecalcibacteria, veillonella and rothia while in adults an increase in proteobacteria and a decrease in bacteriodetes and firmicutes are common. hence, restoration of the microbiome with probiotics and prebiotics can be an alternative therapy. the digestive tract is the home of most bacteria in the body. although the vast majority is housed in the intestine, some do find refuge in the stomach. despite the inhospitable environment presented by this acidic organ, the microbes belonging to the helicobacter spp have set-up their home here. they have done so by learning how to tame the low ph these environs are immersed in. they cling to the mucus of the cell-wall where the acidity tends to a bit more manageable. by neutralising this unfriendly territory, these microbes are able to develop a friendly habitat where they can reside. even with these territorial adjustments, the stomach is the organ that harbours the least amounts of bacteria. however, the perturbation of this microclimate can quickly change this microbial landscape. the intake of medications like the proton pump inhibitors and antibiotics tend to promote a shift in this microbial population to the upper confines of the gastrointestinal tract. once, this uncontrolled colony is established, it produces ammonia that compels an empty stomach to generate acid. it is critical that this digestive compartment is acidic only when it has food in its midst. any change in the acidity in the absence of food distresses this organ. it is more or less like the stomach is chewing itself. this becomes the genesis of aches and heartburns that result into peptic ulcers. there is a rise in this microbially-induced disease around the world and the disruption of the fine working arrangement struck among the invisible residents may be at play. it is not surprising that the majority of ulcers can be cured by antibiotics and not by drugs aimed at diminishing the acidity of stomach, a finding that has dismayed many pharmaceutical companies as they have invested heavily on the incorrect cause of the disease. the understanding of how the disruption of these gastric microbial communities will pave the way for better remedies ( fig. 3 .7). the majority of the constituents of our microbiome is lodged in the small and large intestines with the latter harbouring the bulk of the invisible partners. once the colonies are established in these locations, the stability of the residents is constantly being questioned due to the passage of foods and other edibles that transit through. this environment is under constant flux due to our daily intake of foods that can come in all shape, size, content, well-done, rare, or raw. the colonizers have to adapt. low carbohydrate, high fat, high protein, dietary fibres, medications, antibiotics, sugary drinks all have major impact on the ecosystem. this constant pounding by these diverse ingredients, roughly around 60 tons during our life span is bound to take its toll on these miniscule residents within. such a situation is akin to us changing our clothes conatantly in response to temperature changes in the environment. how would you feel if you have to face snow, rain, sun and fog on an ongoing basis and keep modifying your outerwear continually ( fig. 3 .8). whether the food is starchy, oily or meaty; the microbes have to adjust. a shift from a high fat/high sugar diet to a regime of low-fat/plant-based polysaccharides can change the gastrointestinal microbial ecosystem in a matter of days. for instance, while bacteriodes spp thrive in people who consume high fat foods, prevotella spp dominates the guts of individuals who eat more carbohydrate-rich products; refined sugar intake on the other hand favours clostridium spp. the lovers of vegetarian diets are host to less pathogenic bacteria while protein-rich nutrients tend to provoke increased activity of enzymes like nitroreductases derived from microbial sources. this situation contributes to the weakening of the inflammatory response and prevents the metabolism of short-chain fatty acids (scfa). remember the oxidation of scfa like butyrate provides the intestines with an important source of energy and perturbation of this process can result in abnormal physiological functions. preserved foods, dehydrated vegetables and alcoholic drinks with their high content in sulphate provide a fertile ecosystem for suphate-reducing bacteria like desulfovibrio spp to thrive and distress the body. these micro-organisms generate metabolites that restrict the growth of probiotics that help us execute numerous tasks. medications like opioids and the popular diabetic drug metformin impair the mobility of the gut. these are also responsible for shifting and deranging the community-like environment that good bacteria nurture. this disruption provides an opportune situation for bad microbe like the clostridium difficile to multiply. even psychological stress that is known to trigger the production of signaling chemicals like catecholamines has an impact on the microbiome. well-established microbes like lactobacilli and bifidobacteria that are known to confer a number of healthy attributes in the body tend to diminish (box 3.4). box 3.4 food additives, dysbiosis and health impact numerous chemicals are introduced into foods to improve taste, to extend shelf-life, to add volume, to enhance appearance and to impart a variety of other properties. some of these are known to interact with the microbial communities in the gut and perturb the fine communal balance. dietary emulsifiers like carboxymethyl cellulose (cmc) is one of the additives that is widely utilized in foods, cosmetics, and hygiene products. ice-cream, cookies, toothpaste and laxatives are some of the products where this polysaccharide provides texture, viscosity and structural integrity. despite being mostly composed of glucose, cmc cannot be digested either by the visible or the invisible organs. however, it creates a major ecological change in the gut by interfering with mucin, a natural barrier lining the gut. mucin is heavily glycosylated and act as a potent fence against any opportunistic pathogens to access the inner walls of the intestine. it inhibits the absorption of dietary flavonoids and also promotes the proliferation of microbial flora desired by the body. these functions are perturbed by cmc as it shares some chemical and physical features with mucin. this disruption results in dysbiosis leading to the multiplication of pathogens and their translocation into the intestinal tissues. there is an increase in proteobacteria spp and inflammation ensues. chronic intestinal complications have been attributed to these additives. hence, it is not surprising that these chemical, environmental and behavioural changes that the gut microbiome has to contend with invariably lead to the disturbance of the delicate balance cementing the microbial communities and the host in an effective functional relationship. this flux in the gut ecosystem creates conditions for the abnormal proliferation of some members at the expense of others. the subsequent activation of enzymes and production of disease-causing factors can contribute to such maladies as irritable bowel syndrome (ibs), colorectal cancer, rheumatoid arthritis (ra), type 2 diabetes, obesity, cardiovascular complications and neurological disorders. some of the metabolic diseases like diabetes, obesity and heart ailments have reached an epidemic proportion globally. a recent report revealed there are more obese people than underweight individuals, a phenomenon that is a first for human history. an average person has become 1.5 kg heavier over each decade. thus, if your grand-father was say 50 kg, your dad is 65 kg and you will be 80 kg at the same age of course. this scenario will be true if nothing else changes. the study on body mass index that was done over 40 years in 186 countries is alarming indeed. policies on food and the quality of food we have access to will help to some extent. it is not surprising to see various north american cities are imposing an obesity tax aimed at sugar-laden soft drinks. examining the role of our microbial ecosystem is also pivotal if this issue is to be remedied. the gut microbiome is an important participant in the manner we digest food, extract the maximal energy and nourish the rest of the organs. a disruption in the microbial landscape can trigger metabolic diseases. for instance, during irritable bowel syndrome (ibs) microbes belonging to the firmicutes family decrease while an increase in members of the bacteroidetes family is observed. this disorder in the intricate microbial balance propels a concomitant rise in facultative bacteria like the enterobacteriae spp. the unregulated establishment of the microbial community tends to impair the integrity of the mucus lining of the intestine. this shift perturbs the ability of the resident intestinal microbes to properly communicate with the mucosal barrier; such a situation results in the inability of the body to tolerate the harmless bacteria and neutralize the invading squatters. following this distress imposed on this natural fence, conditions are perfect for the release of signals and chemical shuttles by the microbes to enable their migration across the intestinal defensive wall. this sequence of events forces the host to activate its guards with no clear mandate on the proper target and the result is an unintended inflammation giving rise to crohn's disease and ulcerative colitis. these are the two most prevalent forms of ibs that can be traced to the perturbation of microbes residing in the gut. in fact, these diseases can be mitigated by increasing the presence of firmicutes in the gastro-intestinal tract. it is clear that the conditions promoting the opportunistic microbes and the colonizing factors they produce are at the root cause of these disorders and re-establishing the original microbial communities goes a long in alleviating the pain of individuals suffering from these complications. obesity is a major problem afflicting the world. the rise in overweight individuals has been staggering and this malady attacks regardless of any economic and geographical boundaries. almost all countries surveyed are experiencing the illeffects of this metabolic disease. a variety of elements such as diet rich in simple carbohydrates, low in vegetables and fibres; life-style and genetic factors may be at play. however, the disturbance of the microbial harmony in the body cannot be discounted as a potential trigger responsible for the soaring rate of obesity around the globe. there is a clear distinction in the microbial landscape associated with obese people compared to underweight individuals. lean individuals tend to have higher amounts of microbes belonging to the bacteriodetes family while obese subjects and those suffering from metabolic syndrome are home to more members from the firmicutes family. although the specific species of these two microbial families responsible for the lean and obese traits have yet be catalogued, it is clear that obesity is characterized with increased levels of toxins like lipopolysaccharide (lps) in the blood. symptoms associated with weight gain and decreased sensitivity to insulin have been attributed to the presence of microbial toxins. hence, modulating the nature of the gut microbiome and restoring the proper microbiota have to be included as part of the strategy dedicated to combating these disorders. the food we eat is a major instigator of the establishment and fluctuation of the microbiome we possess. in fact, the adage we are what we eat applies aptly to the microbiota that constitute our body. one can even add that our physiological processes are the way they are because of the microbes we own. these invisible partners that accompany us throughout our live-journey are part of the elaborate communities responsible for our well-being. however, this is not a permanent relationship as it is susceptible to evolution and disruption by what we eat. this intimate relationship that we have forged with our invisible partners and all of our other bodily organs faces lots of twists and turns as we navigate through our lifelong journey. in the case of our microbial ecosystem these changes are non-stop as it is extremely prone to the vagaries of what we put in the mouth. and this is a daily activity that is most relentless and continual and commences the day we are born and ceased only upon our death. indeed it is important to remember that every component of body is in constant flux, we are never exactly with the same body parts that we are born with. these are evolving every second. for instance, we get a new skeletal system every 40 years and this happens on an ongoing basis day by day. otherwise you will be soft like jelly one day and then wake up the next morning with a brand new skeleton. thus, depending on our eating habits, we may be saddled with a microbial ecosystem that can promote or impede our wellness in the same way we have toned body if we exercise or we are stuck with a flabby belly if we are a potato couch. a fat-rich diet together with a combo of a sugary drink is sure a concoction to upset the fine balance of our invisible organ. such a nutritional habit is responsible for the non-alcoholic fatty acid disease (nafld) and cardiovascular complications. these greasy foods are known to promote the proliferation of some bacteria and arrest the growth of others. the establishment of this unbalanced ecosystem is a perfect brewing ground for the genesis of liver and heart diseases. these oilladen nutrients contain copious amounts of choline, a chemical responsible for the yellow colour in the egg yolk. it plays an important role in the development of the brain in children. however, its excessive consumption via the food we intake specifically in adults can be problematic and the unwelcomed microbial residents aggravate our overindulgence in these choline-containing goodies. in reality our gut microbiota transform this into a product known as trimethylamine (tma). this diversion of choline into tma prevents the body from making some good lipids and subsequently leads to the accumulation of the bad lipid known as triglycerides. remember the number 200 associated with triglycerides in the blood of adults. this magic number if higher is a relatively precise predictor of potential coronary abnormalities. these triglycerides have nowhere to go but to accumulate in the liver where they become the precursor of fatty acid disease. this is not all that can come out of this greasy food, it can become worst. if you harbour microbes that can metabolize tma i.e. process it into the oxygenated variety known as trimethylamine oxide (tmao), this can spell danger for your heart. the benign tma falls prey to microbial manipulation in our gut that renders this relatively innocuous agent into a toxin with devastating impact on our well-being. tmao is an important tell-tale sign of cardiovascular diseases. there are other intestinally derived toxins fuelled by microbial activities that can cause havoc to the normal functioning of our body. sulphate derivatives of aromatic chemicals originating from microbial intervention in the intestine can be a major burden on the kidney and may lead to renal abnormalities. controlling the microbes that are in the business of transforming harmless chemicals into noxious ones is critical strategy that need to be pursued in order not to succumb to the microbial imbalance promoted by fatty foods (fig. 3.9 ). even though we may not be completely aware there is an important communication corridor between the gut and the brain that is nourished by numerous signals emanating from the microbial activities in the intestine. the gut-brain axis relies on the messengers and/or their precursors generated by the microbes we harbour. they produce short-chain fatty acid (scfa) like butyrate and neurotransmitters like γ-aminobutyric acid (gaba), dopamine and serotonin. whenever you have a rewarding feeling due to some activity like eating that you are engaged in, blame it on dopamine. these instruction-laden chemicals that are also produced by other organs in our body are central to numerous tasks executed by the brain and can stir our behaviour in one direction or the other depending on the concentration of a specific neurotransmitter. hence, factors that modulate the flux of the microbial communities and their propensity to dish out these neuro-active commanders have tremendous influence on our health and well-being. for instance the lack of microbial diversity associated with ageing impedes the ability of the body to generate scfa such as acetate, propionate and butyrate that supply the brain cells with energy. the loss and/or the rationing of the nutrients fuelling the brain result in a reduction of cognitive and memory power. this attribute is a common characteristic reminiscent of ageing. hence, the propensity of people in retirement homes not to remember or retain mundane facts (fig. 3.10) . the microbiome definitely has its imprint on the functioning of the brain, a feature that has yet to be fully deciphered. for instance, the amino-acid tryptophan is the precursor of numerous neurotransmitters that dictate a variety of our behavioural responses that are usually tailored to the stimuli we receive. this is an essential nutrient that humans cannot make with their own traditional organs and have to acquire it from the food we eat. however, depending on our microbial communities we can easily have ample supply as numerous gut microbes are capable of synthesizing this nutrient; but with caveat that the amounts of tryptophan we have access to need to be modulated if our response is to be commensurate to its presence or its derivatives. any abnormal variation of this commodity in our body can become a harbinger of neurological complications. a shift in microbial communities induced by a myriad of factors can create havoc with blood tryptophan levels. this can then results in depression, mood swings and neurological ailments like parkinson's or alzheimer's diseases. keeping a careful watch on our fig. 3 .10 dysbiosis, abnormal metabolite production and neurological disorders microbial partners and their ability to generate these brain responsive signals will lead to better health outcomes (box 3.5). the ability of the microbiome to produce a variety of neuroactive chemicals makes the invisible organ a potent modulator of human behavior and an instigator of neurological diseases. for instance, parkinson's disease is an incurable adult neurodegenerative disorder characterized by abnormal movements due to defective motor control. dopamine production is impeded and there is an increased formation of aggregated neurotoxic protein known as α-synuclein. these two biochemical manifestations may be shaped by the nature of the microbial residents by limiting precursors of dopamine and activating the immune system with the release of pro-inflammatory chemicals like lps. the gut microbiome in parkinson's patients is usually characterized by a decrease in prevotella spp and an increase in enterobacteria spp. a diminution of mucin synthesis increases intestinal permeability and leads to an acute dysbiosis that contributes to the abdominal discomfort, bloating and premature satiety reported in these patients. autism spectrum disorders (asd) are another set of neurological perturbations leading to social and behavioural impairments including repetitive behaviours and nonstandard communications. here again, the microbiome may be a contributing factor. a decrease in veillonella spp coupled with a rise in clostridium spp and campylobacter spp have been reported. microbial products like pcresol has been observed in elevated amounts in autistic children and 4-ethyl sulfate (4-eps) has been shown to trigger anxiety like behavior. this microbial link is prompting the search of probiotics (e.g. bifidobacterium fragilis) that may help in curing these diseases. cancer is a multi-factorial disease that is a major global concern. almost everyone knows of someone who has been affected by this disease. numerous governments have recognized this disease as a national priority and have decided to provide all the support necessary to fight cancer. although life-style, genetic disposition and environmental factors are important contributors to the spread of this disease, it is becoming amply clear that our microbial landscape and cancer proliferation are interconnected. it is being increasing recognized that the microbiome plays a key role in preventing and promoting cancer. the gut microbial ecology provides an important cover against invading pathogens that contribute to the onset of tumour formation. however, a shift in microbial communities induced by diet and pollution creates a favourable environment for opportunistic microbes to thrive and neutralise the protection offered by the finely tuned original microbial guards. the invading microbes produce virulence elements responsible for unimpeded cellular growth, a key feature of all cancers. they also put in motion processes that result in the instability of the dna and furthering the progress of cancerous cells. understanding the communal work of the intestinal microbes is pivotal if this problem is to be tackled. indeed it has been shown that africans from rural areas exhibit lower risk of colon and rectal cancers due to the increased abundance of the microbes known as bacteroides spp. these are avid producers of short-chain fatty acid like butyrate, an important energy-producer and a promoter of cellular growth. this is a critical signaling molecule that can goad the body to synthesize sentinels that stop cancer cells on their tract. on the other hand, the group of individuals whose colon is home to higher amounts of prevotella spp tend to have higher levels of bile acid and lower amounts of butyrate. this switch in colonic microbial ecology is suspected to be responsible for the colorectal cancers ( fig. 3.11) . the prevotella-rich individuals are programmed to secrete bile acids in the feces. these compounds are known to promote the proliferation of cancerous cells. the interplay between these two microbial communities and their ability to produce these metabolites afforded wellness to one group and colorectal cancer to the other. hence, the promotion and nurturing of functional microbial communities and limiting the presence of unregulated microbial ecosystem in the gut are pivotal to maintaining our wellbeing. this invisible organ has to be tended in the same manner like any other visible organ; one cannot expect to have working lungs supplying the furthest nooks in the body with oxygen if one indulges in smoking or toiling in occupation with toxic air. this cardinal rule also applies to the microbiome even if its anatomical features do not readily pop out to our eyes. otherwise we run the risk of turning this organ that we almost never see but hear rumblings of once in a while into a cancer-causing entity. the critical attributes of these microbes need to be tapped as cancer preventers and fighters. the microbiome is an essential component of humans if not of all multicellular organisms. this invisible component of the body that quite often makes itself heard with a rumbling sound is involved in a variety of biological tasks that are essential for the proper functioning of any human. although these microbes residing in and on us have their genetic information they are bound by the communal existence they have adopted. the role and behaviour of each member are dictated by the host and other members of the collectivity. this harmony and synchronicity of purpose force everyone to comply with the rules set-up during the establishment of the community. however, these communities evolve in relation to the host and the changing landscape they have to deal with. they accompany us from the very beginning when we are developing till death. it is becoming more apparent that these microbes contribute to our development and eventually mould us the way we are both anatomically and physiologically. they have a say virtually in all aspects of our life and prod us as we go about our daily living. from providing essential nutrients like vitamin k that we are dependent on but incapable to make on our own to protecting us against opportunistic organisms and helping heal our wounds, these microbes partake in a myriad of tasks just as visible organs do. however, their constituents and interactions like all other organs in the body are modulated to large extent by the changes in environment, food, stress, and hormonal fluctuations we are subjected to. the invisibility of this organ and its dispersed anatomy have contributed to the relegation of the microbiome to a low esteem in the hierarchy of our body parts. but this view is being discarded at a rapid pace as intriguing information about its role is being revealed. its intimate link to our existence was only visualized very recently. what you cannot see, you cannot appreciate. this dictum fits perfectly the microbiome. the advent of next generation sequencing (ngs) coupled with bioinformatics tools is laying bare the indispensability of the microbial communities roaming within and on us to our very existence. our life will not be the same without our intricate network of microbial communities. hence, understanding how this invisible communal habitat is constituted, how it evolves and how the various partners communicate amongst themselves is crucial for our being. the host will not exist without the microbiome. it is as crucial as the heart and any other body part. this mission is as critical as our desire to unravel the workings of the brain or to venture in the outer galaxy. its systematic functional identification will be akin to the discovery of a new organ as in occurred in the sixteenth century when human was first beginning to comprehend the workings of various body parts. just imagine the excitement when the italian surgeon, realdo columbo identified how the four valves of the heart permitted the flow of blood in only one direction i.e. from the right ventricle to lungs and back to the left ventricle and on to the aorta. we are on the brink of tantalizing discovery on a part of our body that has long been ignored due to the lack of proper tools to decipher the microbial communities. it is indeed more exciting as this invisible organ has at least 1,000 times more genes than our own visible body. the microbiota we possess must play an important role in our development and we are physically and physiologically the way we are because of them. we would be entirely different if it was not for the microbiome and this holds true to most if not all organisms wandering on this planet and most probably beyond. the proper functioning of this community with multiple partners depends on the finely tuned relationship among all the constituents. every member operates in a mode that is beneficial to this cooperative life-style where interdependence is the modus operandi. however, this harmony can be perturbed by a variety interfering influences and can result in a multitude of ailments. the intrusion of opportunistic organisms fuelled by a change in the ecosystem gives rise to dysfunctional communities that are the precursors of debilitating diseases like cancers, ibs, and vaginosis. the latter is a disease arising from the uncontrolled proliferation of microbes such as gardnernella vaginalis, veillonella spp, and bacteriodes spp. that promotes an increase in ph, fatty acids and polyamines (fig. 3.12) . cadaverine, a polyamine secreted during this dysbiosis is the cause of the malodor characteristic of the disease. once the fine balance involving the constituents and the signals that are responsible for a proper microbial community is uncovered, we will be in a better position to predict what makes us tick and what ails us. this knowledge is just now beginning to emerge and ignoring this important aspect of our body will be to our peril; it would be akin to not wanting to know how the brain functions (fig. 3.12; fig. 3 .13). the microbial communities that constitute our microbiome are dependent on a myriad of factors such as the genes we inherit, our mother's milk, the environment we live in, our hobbies, the seasonal changes we are subjected to, the food we eat, the life-style we lead and the medications we take. despite the ability of our microbiota to respond and adjust to these situations, the invisible organ can be influenced by either taking in select beneficial microbes with known functional attributes or by consuming foods and plant products that promote the proliferation of specific microorganisms. this microbiome-rearing strategy is akin to feeding our brain with the books we read or the educational programs we watch or the games we play. remember some eager mothers keen on giving their children a head-start in life, read to them or play music even when babies are in the womb. to promote a healthy life-style, seniors are being encouraged to partake in neuron-stimulating games on a regular basis. this brain exercise has becoming a common place in residences for the elderly. thus probiotics, prebiotics and synbiotics can be utilized to guide the microbiome to perform optimally and ameliorate our well-being (fig. 3.14) . probiotics are live microbes administered as foods or even in capsules that confer health benefits on the body. microbial cultures have been consumed by humans since the dawn of civilization. mongolian women sprayed fermented milk on horsemen and their horses in belief that this provided strength and health on the recipients, while in some civilizations fermented milk was utilized to treat a variety of ailments. dahi, a fermented milk is widely consumed in the indian sub-continent and is known to impart numerous healthy outcomes. however, the first clinic trials on the health claims of these bacteria-rich fermented foods were not performed until the twentieth century. eli metchnikoff who obtained a nobel laureate in medicine was first to correlate the longevity of some bulgarian citizens to the prolific consumption of fermented milk that was rich in lactobacillus bulgaricus and streptococcus thermophilus. in 1930, the japanese scientist shirota isolated microbes with probiotic properties from healthy human subjects. these were later utilized in the development of milk products that were commercialized as yakult. subsequently, a french pediatrician reported the lack of bifidobacteria in stool of infants suffering from diarrhea. in 1965 the term probiotics was coined by lilly and stillwell to describe products that stimulate the growth of microorganisms beneficial to the body. it was in 1984 the first probiotic species, lactobacillus acidophilus was introduced followed subsequently by bifidobacterium spp. their use in food products is widespread. the significance of probiotics in fortifying the immune system has officially been recognized fig. 3 .14 nurturing of the microbiome, the brain and the muscle. (activities and nutrients involved in fortifying these organs) fig. 3 .15 consumption of probiotic-rich foods around the globe by the world health organization (who). currently a wide variety of microorganisms such as e. coli, propionobacterium, enterococcus, streptococcus, leucomostoc, and bacillus cereus are being consumed in order to regulate and adjust the body's microbiome (fig. 3.15, box 3.6) . box 3.6 probiotics: occurrence and uses worldwide humans have been consuming microbe-laden foods unknowingly since the dawn of civilization. fermented milk, vegetables, meat and fish were and are a regular part of the daily diet for most people around the globe. recently probiotics enriched foods like yogurt, yakult, kefir, dahi and cheese have become a regular repertoire of natural products that nutritionists are eager to extoll the health virtues of. lactobacillus spp, bifidobacterium spp and bacillus spp. are the more prominent probiotics even though other microbes are being added to this list. they are also being used in non-consumable items like oral care gel and anti-ageing serum. their ability to produce acid, enzymes, scfa, immune responsive factors and to help establish functional microbial flora have made these probiotics excellent candidates to cure a variety of diseases that are provoked by dysbiosis. while e.coli nissle provides relief to patients suffering from ulcerative colitis, a disease like vaginitis can be remedied with lactobacillus rhamnosus gg. irritable bowel syndrome victims can find comfort with the intake of bifidobacterium animalis and lactobacillus acidophilus. the role lactic-acid microbes like bifidobacterium breve has been recognized in diminishing high blood pressure due to their ability to produce vitamin d, anti-hypertensive factors and interrupting cholesterol absorption. although influence of probiotics in promoting wellness and as therapeutic agents aimed at numerous illnesses are becoming more prominent, their usage will become universal once the dosage and the intake frequency of these microbial supplements have been properly evaluated. probiotics not only help the body to fine-tune the microbiome, they can also perform some very specific functions. depending on the probiotics, these microbes act as a barrier and prevent colonization by opportunistic bacteria. they do so by re-enforcing the protective function of the gut mucosa and by generating signals that arrest the invasion by infectious organisms. they produce antibiotics, antioxidants and improve the body's immune system. probiotics are also known for their ability to synthesize scfa and vitamins, ingredients essential for numerous metabolic activities. they secrete enzymes that help in digestion and in the elimination of wastes. a good probiotic should be able to impart health benefits to the host and be bestowed with no pathogenic properties. its presence in the microbial community should enhance some biological functions and/or curtail any negative influence on an individual's well-being. these can preferably be taken orally and must survive the harsh environment of the digestive system, especially the stomach where the ph can be unforgiving. the low ph of the stomach can be avoided if the probiotics are mixed with food such as milk, dietary fibres and yogurt. they can be designed to generate specific biomolecules that can be of benefit to the host. for example, lactose-intolerant individuals can consume probiotics with the ability to synthesize lactase or galactosidase that helps in metabolizing the milk sugar, lactose. probiotics have virtues almost like stem cells. stem cells i.e. cells that have not yet made up their mind what they will become or which organ they will develop into can be utilized as a therapy to fortify ailing components of the body. for instance, they can be injected in the cornea or the liver with the proper commands that enable them to mature into corneal or hepatic cells that become part of the rejuvenated organs with optimal biological functions. probiotics act in a similar manner in regard to our microbial communities. they can be consumed with the aim of enhancing a specific function like in the case of a select targeted fortification that is desired in the body. individuals suffering from the inability to digest milk are readily relieved of their aversion to milk or milk products by the consumption of lactobacillus. this microbe secretes lactase, an enzyme that can clip the milk sugar lactose into glucose and galactose which are then utilized by the body. probiotics such as aspergillus oryzae found in fermented foods like soy sauce, and sake secretes amylase and lipases that help in the digestion of starchy and oily meals. in instances where the microbiome has been infiltrated by opportunistic microorganisms that prevent the invisible organ from performing its regular task, an intake of the probiotics can shift the microbial balance toward a more fruitful one for the body. one case in point is the colonization of the dental space by streptococcus, a microbe responsible for carving cavities on the tooth. food enriched with various species of lactobacillus can rectify this situation by creating an unfavourable situation for the invading bacteria to survive. among other various biological weapons they have in their armoury, lactobacillus group of probiotics can generate an acidic environment. this situation is known to impede the growth of the occupying bacteria and arrest their assault on the teeth. unlike the stem cells that are mainly involved in regenerating desired tissue or organ, probiotics can tilt the balance of a non-functional microbiome towards a functional one by quashing undesirable elements in the community. they can also be engaged in a targeted task designed to thwart a discomfort an individual is experiencing as in the case of intolerance to lactose or abnormal movement of the digestive system. world-wide people have been consuming fermented products laden with probiotics. these foods have evolved through centuries and each region has its own speciality of delicacies full of microbes. these probiotics have become part of the culinary culture and it will not be surprising if we learn that our palates have evolved accordingly. yogurt, a diary product supplemented with microbes lactobacillus, bifidobacteria and lactococcus is part of the grocery shelves in almost all countries. in india dahi, a fermented milk product rich in lactococcus lactis and lactobacillus acidophilus is taken with nearly all foods and its curative powers are readily touted. in the caucus region, kefir with its bountiful of lactobacillus, lactococcus, leuconostoc and bifidobacteria is a daily staple. this is derived from goat's milk and contains yellowish grains resembling cauliflower. these grains are in fact polysaccharide capsules full of probiotics. in japan the miso soup prepared from barley, rice, beans and rye is king while in africa uji the probiotics charged maize or sorghum or millet is widely cherished. although not currently available probiotics with the ability to metabolize ethanol or cure obesity will be a welcome help to those individuals who are susceptible to adverse reaction upon intake of alcoholic drinks or have difficulty controlling their body mass index (fig. 3.16 ). the mouth is literally a continuation of our external environment and is being constantly challenged by the microbes we are exposed to in our surroundings. even under this threat, the soft and hard components of the mouth harbour a good number of microbial communities that allow them to fulfill various essential tasks. the change in the chemical milieu in the mouth triggered by the intake of foods provides a fertile landscape for foreign organisms to set foot, proliferate and disturb the working microbial harmony. this happens at the onset of dental cavities when streptococcus rapidly colonizes the tooth. in this instance, a probiotic like lactobacillus rhamnosus can spring in action and create an acidic environment by the secretion of lactic acid. its ability to produce antimicrobial factors administers another debilitating punch thwarting the streptococcus-driven assault. this probiotic also helps train the immune system to fend the noxious microbe. bile, a product that is produced in the liver has been shown to be involved in a variety of tasks that make the body ticks. its acid derivatives are emerging as important signals that allow us to control our weight, regulate the level of cholesterol in the blood and determine how much fat we are going to store. the key enzyme that facilitates this formation of the bile-derived acids is bile salt hydrolase. a number of probiotics like lactobacillus, bifidobacteria, bacteriodes and enterococcus spp is known to secrete this enzyme. these probiotics can be designed to produce this enzyme that will be an excellent tool to control weight gain. this role of probiotics is akin to the use of lactase-producing lactobacillus. intake of food enriched with lactobacillus is a common therapy given in order to easy the misery of people suffering from the aversion to milk. in fact, lactase derived from probiotics is the most popular form of therapy for this ailment. nearly 90-100% adults in east asia cease to produce lactase as they reach adulthood. although it is totally natural not to have lactase after the weaning years, the omnipresence of dairy products significantly raises the importance of this enzyme beyond our childhood. hence, the remedy provided by lactobacillus-supplemented foods or capsules is a boon to the adult population world-wide who wants to partake in their dairy-laden delicacies. the curing of enzyme deficient diseases or conditions with the aid of probiotics will become a common practice as our understanding of the microbiome becomes clearer (fig. 3.17) . in diabetic patients a microorganism referred to as akkermansia muciniphilia that shelters in the mucus in the intestine can be an excellent candidate to promote carbohydrate metabolism. these microbes constitute 3-5% of the gut microflora and are known to stimulate glucagonlike peptide (glp), an important modulator of blood sugar. glucagon and insulin are the sugar police in the blood. glucagon becomes active at night during asleep. this is when the blood sugar is low. the sugar sentinel ensures that we wake up healthy by maintaining the right sugar balance. insulin on other the hand, protects against high blood sugar. for instance, when you indulge in a big bar of chocolate, it preserves the proper blood sugar and directs the extra to be stored. hence, people with a hardy dose of a. muciniphilia are less insulin resistance, a major contributing factor to obesity. the abundance of these microbes decreases with age and the intake of high fat diet. the magic of a.muciniphilia is in the production copious amount of mucin, a slimy lining for intestine that promotes a diverse microbial ecosystem and fends off opportunistic microbes. hence, the population of this blood-sugar balancing microbe can achieved by either taking it as a probiotic or by consuming nutritional fertilizer like fibers aimed at stimulating its proliferation. bifidobacteria is another group of microorganisms that dissuade infectious microbes to colonize the gut by blocking the anchoring sites and stimulating the immune system. it is not surprising that they constitute almost 80% of the cultivable microbes in the stool of infants as opposed to the meagre 20% found in adults. they contribute to the defense power in babies as they are vulnerable at this tender age (fig. 3.18a) . infants especially those who are born premature can also suffer from damaged intestinal tissues that begin to die. this disease known as necrotizing enterocolitis is characterized by bloating and swollen abdomen responds favourably to probiotics. use of the probiotic lactobacillus is quite effective in mitigating this disease. on the other hand, the intervention with a concoction of bifidobacterium, propionobacterium and lactobacillus significantly reduces the risk of allergy in infants delivered by c-section. in fact these c-section babies are devoid of the microbes that mothers impart on them if they are not born naturally. recent studies involving the sprucing the babies with the mums' microbiota are showing positive results. this kind of probiotic treatment where someone else or one's own microbe is used as probiotics to rectify aberrant biological activities is becoming more prevalent. transfer of microbes from fecal matter, ear wax, skin and other body parts is gaining medical traction and are being implemented in health centers world-wide. microbial transplant undoubtedly impart numerous health benefits (fig. 3.18b ; 3.18c). elderly individuals are another segment of the population who can benefit tremendously from the enrichment of their microbiome with probiotics. ageing is characterized with a sharp decline in microbial diversity and density. this phenomenon is the leading cause of the decrease of metabolic activities and in some cases of physiological abnormalities observed in seniors. the lower abundance of bifidobacteria coupled with the increased presence of enterobacteriaceae is a common predictor of the ageing process and such a shift in microbial population is responsible for the diminished production of enzymes and essential vitamins like vitamin b that are critical in maintaining a constant supply of energy in the body. there is also a build-up of toxic products as the proper microbial communities involved in their decomposition are severely hampered. this situation is analogous to someone not going to the toilet on regular basis. the build-up of noxious elements in the colon can be the cause of a variety of ailments including head aches and digestive discomfort. the advanced age of centenarians is attributed to a diversity of microbial populations that are a hallmark of all individuals living beyond the ripe of age 100 years. the mission of these microbes may be compared to the role stem cells play in rejuvenating the organs and extending their functional life span (fig 3.19 ). in this instance the diversity of the microbes observed in centenarians may be allowing these microbiota to supplement some of the functions their visible organs cannot perform or to generate chemical ingredients triggering the proper physiological responses from these ageing organs. hence, harnessing the power of probiotics in reconfiguring the dysfunctional microbiome characterized by the ageing process can be an important gamechanger in the life-style of seniors. this will be critical in seniors who are usually on microbiome-distressing medications. that is why it should not come as a surprise if elderly individuals take more time to heal and are invaded at a rapid rate by opportunistic bacteria. in fact microbial infection is a major concern when elderly patients are admitted to health facilities. they may be in for a hip replacement but unfortunately they run a higher risk of being contaminated by hospital dwelling-microbes. the prevalence of hard to eliminate microbes like clostridium difficile in elderly patients is a problem world-wide. and often infectious outbreaks occur in these places. unbalanced nutrition and erratic eating habits induced by reduced sensation in the olfactory and taste systems add to the dilemma facing seniors. these conditions create a nutritional environment deficient in essential nutrients like calcium and vitamins that further exacerbate the microbial ecosystem. intake of the probiotic bifidobacterium longum stimulates the proliferation of other bifidobacterium spp. administration of lactobacillus acidophilus is known to increase the synthesis of antioxidants like glutathione and oxidant bursting enzymes like catalase. while the regular consumption of bifidobacterium animalis helps reduce the time food transits in the gut, the probiotics lactobacillus rhamnonus and a propionibacterium spp contribute to the improved defecation frequency. hence the implementation of a nutritional regime rich in probiotics will go a long way in easing the discomfort and some of the ailments that are associated with old age. evidence-based research is revealing how probiotics can help reverse ailments caused by the disruption of the microbial communities in our body. irritable bowel syndrome (ibs) is one such disease where a perturbation in microbial population is the main cause of the disease. this shift in the ecosystem of the microbiota is punctuated by a loss in immune tolerance and a rise in inflammatory response. to mitigate this situation and to remedy this ailment, the administration of probiotics like e.coli nissle has been relatively more effective than the use of antibiotics. in this instance, the probiotics appear to deliver a three-pronged attack on the invasive and crafty microbes. they improve the fence lining the intestine, they out-compete the bad bacteria and they secrete molecular soldiers like hydrogen peroxide and lactate that stop invaders right on their tract. the significance of probiotics as therapeutic agents is only now beginning to be appreciated and is slowly challenging the aggressive use of antibiotics in treating these conditions. unfortunately, antibiotic-based remedies tend to seriously interfere with the workings of our microbiome as their action against toxic microbes also eliminates some of our trusted invisible partners. the uncontrolled proliferation of the stomach residing helicobacter pylori is a cause of concern as it is a risk factor for gastroduodenal ulcers and lymphomas. the intake of probiotics such as lactobacillus and streptococcus thermophilus has been demonstrated to correct this imbalance. the ability of these probiotics to secrete scfa like acetate and butyrate is known to be a key factor in impeding the march of the over-reactive h. pylori. wound healing and cancer prevention are other two activities that probiotics are also involved in. lactobacillus acidophilus that is an excellent candidate with the power to heal injuries is known to arrest the colonization driven by the scheming pseudomonas aeruginosa. the acidic environment nurtured by the lactobacillus renders the ability to conquer the tear on the skin almost impossible. the propensity of probiotics to bind to mutagenic compounds and inhibit the production of carcinogens by opportunistic pathogens is central for their anti-tumour activity. the lactic acid producing bacteria such as lactobacillus acidophilus, bifidobacterium bifidum and streptococcus lactis are routinely being recommended for the prevention of cancers. some select tumours like in colorectal cancers are being treated with the aid of these life-microbial concoctions. hence it comes as no surprise that the use of probiotics as a prevention of diseases and a therapy against some specific disorders is on the rise. the commercial value of this industry is into hundreds of billions of dollars, a figure that is further expected to increase as probiotics are safe and well-tolerated in children, premature infants and in the general population as a whole. furthermore, unlike pharmaceutical products, probiotics are very easily administered mostly as components of foods and the lingering effects of these chemicals are quickly becoming a relic of the past. the microbiome can also be nurtured and programmed with the assistance of prebiotics. these are natural products that foster an environment propelling the proliferation of some desirable microbes. in the same manner as we are always eager to give our visible organs a boost when they are not working well or when they are sluggish, we can revitalize our invisible organ. our more traditional visible organs can be invigorated by taking supplements like vitamins or minerals that provide ammunition to various metabolic activities in the muscle, brain, heart or liver. for instance, athletes take creatine, a product responsible for energy stabilization to improve their performance. creatine and creatine kinase duo enables us to engage in physical activities quickly and fast. without the intervention of this dynamic couple, daily chores will happen in a relatively sluggish manner. individuals with excess body mass consume carnitine with the hope of inducing the various body parts in burning fats. well, the constituents of the invisible organ can be strengthened with the intake of prebiotics. these are like fertilizers that create the proper environment for the desired microbial ecosystem to flourish. they tilt the microbial community in a manner favouring some specific tasks to be performed. for instance, a prebiotic promoting the growth of lactase-secreting microbes will help lactose intolerant people while a prebiotic inhibiting the competitors of vitamin k-producing bacteria will be of immense assistance to patients having difficulty with blood coagulation. prebiotics are excellent nutritional supplements involved in modulating and adjusting the microbiome that can undergo disruption due to ageing, infection, climate change and a sleuth of other factors one may be subjected to as one goes through one's daily activities (fig. 3.20) . what are these magical prebiotics? they are usually plant derived fibers and complex carbohydrates contained in milk that help promote the growth of specific microbial ecology in our body especially in our digestive system. they are mostly resistant to digestion by the enzymes produced by the gut. they are metabolized only by our invisible organ and/or promote proper microbial communities that impart health benefits to the host. the production of short-chain fatty acids (scfa-acetate, butyrate) in response to the intake of prebiotics can contribute to the energy budget of the muscle, can regulate cholesterol biosynthesis and can provide fuel to the colon. stimulation of calcium absorption, reduction in infections and repression of allergic symptoms are some of the other activities prebiotic intake is known confer on the host. these physiological processes are of course a major boon to our well-being as these are like lubricants oiling our body machines. the prebiotics prime the microbiome and this invisible organ is reflective of the prebiotics consumed. as a toned muscle system is indicative of the time spent at the gymnasium, specificity and diversity of the invisible organ is a tell-tale sign of our dietary fiber-eating habit (fig. 3.21) . prebiotics or dietary fibers have been part of human nutrition since the dawn of civilization. in 450 bc hippocrates had noted the laxative attribute of coarse wheat compared to the refined variety. in the 1920s kellogg sang the praise of bran as a nutrient that increased stool weight, prevented diseases and acted as a laxative. all health gurus extoll the praise of the nutritional quality of fiber-rich foods. after a relative quiet epoch in the health benefits of the dietary fibers, their involvement in mitigating ailments like obesity, cardiovascular disorders and diabetes were widely revived in the 1970s and has now become a staple of balanced nutrition. the main prebiotics are the galacto-oligosaccharides (gos) obtained from milk, inulin associated-fructo-sugar (fos) found in chicory roots and xylooligosaccharides (xos) present in plant products like palm oil and corn plants. they also occur naturally in milk, asparagus, garlic, onion, leeks, wheat, oats and soya beans. they are soluble, resistant to the acidic environment in the stomach, fermentable and stimulate growth or the activity of intestinal microbes responsible for the well-being of the host. prebiotics tend to be relatively selective to microorganisms like bifidobacteria and bacteroides. they are converted into simpler derivatives before they reach the colon. here they act as an anchor for the establishment of a unique ecosystem that is aimed at aiding the host in accomplishing a variety of tasks. they generate energy that fuels the muscles and the colon. they are also involved in repressing allergic symptoms. the reduction of infection and promoting the proliferation of good microbes like akkermansia are some other positive features prebiotics contribute to. they are also known to decrease glucose absorption, activate cholesterol excretion, and promote laxation. one of the most intriguing influence of prebiotics in dictating our microbial ecosystem and promoting our well-being has been observed in infants just immediately after birth. babies who are fed their mothers' milk have much better health outcomes than those fed formulated milk. they are less susceptible to allergic reactions and kids nourished by natural milk tend to be less prone to asthma. the gos, a natural ingredient in the mother's milk cannot be digested by the babies' developing guts. they are designed to promote the growth of microbes that are crucial for a variety of tasks at this critical juncture in their lives. one can safely conclude that mother-nature is making these goodies not for the babies but for the microbes feeding on them. in fact, the presence of a unique ingredient known as sialic acid in the milk of some malawian mothers result in well-nourished infants as opposed to infants who are fed by mothers without this magical tonic in the milk. this prebiotic is responsible for the growth of a unique set of microbes that generates simple sugars utilized by infants for their development. even from such an early stage of human life, the body is programmed to depend on these invisible partners. it is not surprising to learn that various milk products are being formulated with oligosaccaharides in an effort to generate increased microbial population in growing infants. the elderly can also benefit from the intake of prebiotics as their microbiota tend to undergo a drastic change and there is a significant reduction in the diversity and abundance of the microbial ecosystem as age progresses. the fructooligosaccharide (fos)-based prebiotics have an excellent bifidogenic activity while resistant starch like sprouted legumes improves bowel movement by promoting the growth of lactobaccilli and bifidobacteria. these microbial fertilizers can be given to relieve seniors of constipation, a condition quite acute in this segment of the population. prebiotics not only promote a healthy life, their intake can be tailored to remedy a number of ailments that are due to dysbiosis i.e the perturbation of microbiota in the body. their ability to nurture a select group of bacteria that possess a range of tools to combat the opportunistic invisible invaders can be put to good use. obesity is a disease that is characterized by low grade inflammation and is punctuated by a decrease in the diversity of gut microbiome, a situation resulting in the ineffective harvesting of calories from what we eat. the inadequate energy extraction from food intake automatically triggers the hunger hormone, ghrelin which stimulates the desire to eat more food. this vicious circle causes the body to gain weight. the utilization of fos prebiotics like inulin-laced pasta decreases the bacterial lps, suppresses the hunger signal, promotes satiety and increases microbial diversity events aimed at countering obesity. a prebiotics is an effective means in controlling weight gain. cardiovascular diseases do also respond well to prebiotics therapy. water soluble fibers such as pectin found in fruits and guar gum from guar beans are known to decrease the bad cholesterol (ldl low density lipoprotein) without affecting the good cholesterol (hdl high density lipoprotein). they also help lower the blood pressure. the positive influence of these prebiotics on the functioning of the heart has been widely documented and accepted as a means of averting cardiovascular diseases. mitigating constipation and prompting proper bowel mobility are the gold standard treatment fuelled by the intake of prebiotics. cereal fibers like wheat bran are religiously utilized to counter any abnormality associated with fecal bulking. prebiotics can also be a potent remedy against cancers. enhanced micronutrient absorption and stimulation of microbes with cancer fighting enzymes like glutathione transferase are some of the mechanisms that these nutritional elements confer to the body. the ability of prebiotics to enrich the diversity of the microbiome is central to its curative power (fig. 3.22; fig. 3.23; fig. 3 .24). prebiotics is almost like a dietary manure that transforms the microbial landscape in the gut. a similar strategy is utilized to help the visible body parts if something goes amiss. during anemia when the level of hemoglobin is low, iron sulfate pills enables the blood system to stimulate the production of this oxygen carrier. in the case of keratoconus, an eye condition where the cornea loses its focusing power, the surgical administration of vitamin b2 allows the eye to function normally. in this instance, the infusion of vitamin b2 promotes the crosslinking of collagen, a biological event that fortifies the cornea and enables it to contribute to visual sensation. the same can be said of lipoic acid and calcium supplements. the former helps fortify the workings of the brain while the latter enable the proper functioning of the skeletal system. as these ingredients assist the target organs optimize their biological roles, the intake of prebiotics provides a proper nutritional environment for the right microbial ecosystem to flourish in order to maximize the output of the invisible organ in promoting a healthy body. however, this is a non-invasive exercise and usually corresponds to an accompaniment of the food we consume unlike the surgical intervention needed to feed the cornea with vitamin b2. hence, prebiotics are natural fertilizers for the microbiome and can remedy the microbial perturbations that the body has to often undergo due to age, environmental change or intake of medications. one can also utilize a two-pronged approach comprising probiotics and prebiotics to regulate an unbalanced microbial landscape. this is termed as synbiotic and can be equated to a multi-drug regime to cure a disease. a combination of these two stimulators can have a more vigorous impact on the invisible organ and can provide a very effective therapy against ailments mediated by uncontrolled proliferation of some opportunistic microbes. the blending of live microbes and the microbial fertilizers that enable them to thrive is a very powerful tool to goad the constituents of the invisible organ in executing a dedicated task. for instance, muscle wasting and inflammation that characterize cancer cachexia has been shown to be mitigated with a concoction of a synbiotic consisting of lactobacillus reuteri and inulin-based fructans (fos). the intake of this synbiotic reduces the population of enterobacteriacae, replenishes the lactobacillus colonies and prolongs the life of the patients. the therapeutic value of the fos and lactobacilli taken together in combatting hemorrhage triggered by bacterial infection has also been recognized. in this instance, a sharp decrease in e.coli counts coupled with an increase in the population of lactobacillus spp contribute to bringing relief to these patients. quite often a cocktail of drugs is prescribed to combat a viral infection; this can be equated to synbiotic therapy. the aids virus, can only be eliminated from the blood system of infected individuals by the use of anti-proteases and medications inhibiting the replication of the viral genetic code. hence, this double punch aimed at aiding the microbiome naturally is of immense benefit to the body. the human body is made of cells that are in constant flux due a variety of factors including wear and tear as age progresses. these can be repaired or rejuvenated with the aid of medical intervention. one can seek the help of a cosmetic surgeon to remove ageing spots or modify the shape of the nose. in case of the microbiome, any perturbations (dysbiosis) that the invisible organ experiences can be modulated by the programmed intake of probiotics and prebiotics. hence, the microbiome behaves in manner that is comparable to the organs composed of visible cells. it is clear that the body is made up of visible and invisible cells. most visible cells assemble as various organs we can see; there are few exceptions like the blood system where the cells are mobile and interact directly and indirectly with all the organs. just like dysbiosis that robs the microbiome of its natural functions, the organs can also be subjected to a number of challenges over body's life span. the inherent repair machinery cannot remedy the situations the organs are facing in a timely manner, intervention in form of medication or surgery is needed to bring them back as contributing members of the body. for example if some oily clutters are impeding the flow of blood, the arteries are unclogged by surgical procedure. if organs of the body are insulted by overuse of some products or by accidental intake of toxic compounds, antidotes are utilized to bring back these anatomical structures in tip-top shape. for instance, fomepizole can give reprieve to a liver challenged by alcohol abuse while high levels of cholesterol in the blood that contribute to plaque build-up in the arteries can be rectified by statin family of cholesterol-busters (fig. 3.25 ). in the same manner any disturbance in the microbial communities constituting the microbiome can be adjusted with the intake of probiotics, prebiotics or synbiotics. these 'therapies' are akin to the medications, the surgery, antidotes or stem cells that are deployed to tweak the visible organs in an effort to bring them to a normal working condition (fig. 3.26) . the fact that the microbiome is invisible and its molecular operation is still not fully understood compared its visible counterparts like the liver should not preclude it from being an important component of the cellular collectivity responsible for the body's well-being. the microbial system spans a wide surface area within and on the body just like the blood system as it imparts extremely valuable functions. this microbial ecosystem is to some extent responsible for the human anatomy and makes it work the way it does. understanding how the invisible organ operates, how the harmony amongst its cells are disrupted and how the fine-balance is reconstituted with the aid of probiotics and prebiotics are essential if we are to understand the intimate details hence, dysbiosis and rebiosis propelled by the infusion of live seeds (probiotics) and the fertilizers (prebiotics) will go a long way toward promoting wellness and will bestow upon us a healthy life probiotics, prebiotics and colorectal cancer prevention immune system stimulation by probiotic microorganisms interactions between the microbiota and pathogenic bacteria in the gut individual diet has sex-dependent effects on vertebrate gut microbiota microbiota and healthy ageing: observational and nutritional intervention studies a gastroenterologist's guide to probiotics the impact of the gut microbiota on human health: an integrative view probiotics and gastrointestinal disease: successes, problems and future prospects probiotics and prebiotics in ulcerative colitis microbiome-wide association studies link dynamic microbial consortia to disease prebiotics: why definitions matter the oral microbiome -an update for oral healthcare professionals probiotics in prevention and treatment of obesity: a critical view comparison of the immunomodulatory properties of three probiotic strains of lactobacilli using complex culture systems: prediction for in vivo efficacy the microbiome in asthma the skin microbiome: is it affected by uv-induced immune suppression? front microbiol 7:1235 the role of bile acids in reducing the metabolic complications of obesity after bariatric surgery: a systematic review recent developments in prebiotics to selectively impact beneficial microbes and promote intestinal health regulation of the immune system by biodiversity from the natural environment: an ecosystem service essential to health functions of the skin microbiota in health and disease psychobiotics and the manipulation of bacteria-gutbrain signals cancer-promoting effects of microbial dysbiosis key: cord-025790-k8v832rl authors: gowelo, steven; mccann, robert s.; koenraadt, constantianus j. m.; takken, willem; van den berg, henk; manda-taylor, lucinda title: community factors affecting participation in larval source management for malaria control in chikwawa district, southern malawi date: 2020-06-02 journal: malar j doi: 10.1186/s12936-020-03268-8 sha: doc_id: 25790 cord_uid: k8v832rl background: to further reduce malaria, larval source management (lsm) is proposed as a complementary strategy to the existing strategies. lsm has potential to control insecticide resistant, outdoor biting and outdoor resting vectors. concerns about costs and operational feasibility of implementation of lsm at large scale are among the reasons the strategy is not utilized in many african countries. involving communities in lsm could increase intervention coverage, reduce costs of implementation and improve sustainability of operations. community acceptance and participation in community-led lsm depends on a number of factors. these factors were explored under the majete malaria project in chikwawa district, southern malawi. methods: separate focus group discussions (fgds) were conducted with members from the general community (n = 3); health animators (has) (n = 3); and lsm committee members (n = 3). in-depth interviews (idis) were conducted with community members. framework analysis was employed to determine the factors contributing to community acceptance and participation in the locally-driven intervention. results: nine fgds and 24 idis were held, involving 87 members of the community. widespread knowledge of malaria as a health problem, its mode of transmission, mosquito larval habitats and mosquito control was recorded. high awareness of an association between creation of larval habitats and malaria transmission was reported. perception of lsm as a tool for malaria control was high. the use of a microbial larvicide as a form of lsm was perceived as both safe and effective. however, actual participation in lsm by the different interviewee groups varied. labour-intensiveness and time requirements of the lsm activities, lack of financial incentives, and concern about health risks when wading in water bodies contributed to lower participation. conclusion: community involvement in lsm increased local awareness of malaria as a health problem, its risk factors and control strategies. however, community participation varied among the respondent groups, with labour and time demands of the activities, and lack of incentives, contributing to reduced participation. innovative tools that can reduce the labour and time demands could improve community participation in the activities. further studies are required to investigate the forms and modes of delivery of incentives in operational community-driven lsm interventions. including insecticide-treated bed nets and effective case management [1, 2] . long-lasting insecticide treated bed nets (llins) and indoor residual spraying (irs) as vector control interventions have made major contributions towards the recent gains [3, 4] . despite these gains, malaria still remains a major public health problem in africa as reported by stable or increasing incidence rates over the past few years in many african countries [1] . development of resistance to drugs [5] and insecticides [6, 7] in the malaria parasites and vectors, respectively, and vector behavioural plasticity, such as outdoor feeding and resting [8] , threaten the efficacy of available interventions to reduce the malaria burden. the shortfalls of the current malaria interventions suggest a need for new strategies that can further reduce malaria transmission. larval source management (lsm), which controls malaria vector populations through reduced suitability of mosquito larval habitats, is recognized as an effective supplementary tool for malaria control under specific conditions [9, 10] . as a complementary malaria control strategy, lsm could be ideal for situations where vector breeding sites are few, fixed and findable [11] . other factors cited for adoption of lsm as a complimentary tool include cost-effectiveness when compared with other tools [12, 13] and its ability to control vector populations that avoid contact with insecticide-based tools [14] . further, the microbial larvicides under advocacy for use in lsm have not, to date, been shown to cause any signs of resistance in vector populations or harmful effects on non-targeted organisms [11] . in kenya, the deployment of lsm as a complementary measure to communities already using llins was shown to significantly improve malaria control compared to the situation with llins used as a stand-alone method [9] . a number of other studies have reported similar results showing the contribution of lsm to malaria reduction in africa [12, [15] [16] [17] [18] [19] . in malawi, like in many other african countries, lsm has not yet been introduced or evaluated for malaria control. this is due to a number of factors including a lack of data on local larval mosquito vector ecology [20] , lack of local evidence for lsm in malaria control, and concerns about the cost of implementation on a large scale. one potential method of managing implementation costs and intervention coverage is to closely involve communities in the application of lsm. this approach could enable adequate coverage of targeted areas through education and skills development of communities about lsm, reduce costs of implementation as human capital is locally available, and increase community acceptance and ownership [21, 22] . a review of case studies concludes that community participation is key to success of interventions [23] . for instance, feasibility of community involvement in lsm has been demonstrated in urban settings in dar es salaam, tanzania, where improved standards of larval surveillance were reported [24] . participation of communities in malaria control has not been emphasized in malawi. instead, communitybased management of diseases in hard-to-reach villages has been implemented by government-employed health surveillance assistants (hsas). therefore, there is lack of sufficient evidence in the country on whether community engagement in malaria control can increase coverage, acceptance and uptake of control interventions. a five-year community-led malaria control project, majete malaria project (mmp), was implemented in southern malawi to investigate the additive effect of community participation in malaria control through community workshops on malaria, structural house improvement and lsm on the strategies recommended in the national malaria control policy [25, 26] . the study could contribute to evidence for community engagement in malaria control in malawi. the majete malaria project (mmp) was a community-led malaria control project undertaken in villages along the perimeter of the majete wildlife reserve in chikwawa district in southern malawi [25] . local communities were involved in the development and implementation of the lsm activities as part of mmp [26] . in this study, conducted 2 years after commencement of community involvement in the lsm activities, the factors influencing implementation and acceptability of lsm for malaria control were assessed using a communitydriven approach. an understanding of these factors could inform the best practices for future development and deployment of community-based interventions. larval source management was implemented in 26 villages as part of mmp from may 2016 through april 2018 as part of a cluster randomized trial described in detail elsewhere [25, 26] . all 26 villages assigned the lsm arm of the randomized trial were included in the current study. all villages were located along the majete wildlife reserve perimeter in chikwawa district (16° 1′ s; 34° 47′ e), southern malawi. chikwawa is hot and dry from september to december, hot and rainy from january to april, and mild and dry from june to august. the district is generally dry with typical savannah type of vegetation though agricultural land use is common in the landscape. the majority of people in the study villages keep livestock with cattle, goats and pigs being the predominant animals. most of the households practice subsistence farming with maize, millet and beans as staple food. the study villages were divided into three sub-regions, called focal areas, spaced roughly evenly around the wildlife reserve and covering a total population of about 25,000 people in 65 villages (fig. 1) [27] . the study was undertaken with community members from the 26 villages spread across the three focal areas, assigned ' a' , 'b' and 'c' . three different groups of respondents were identified: (1) health animators (has), (2) lsm committee members, and (3) members from the broader community. the has and lsm committee members were selected to coordinate the local malaria control initiatives. selection of these groups was led by was village heads in consultation with members of the community [26] . the has and lsm committee members received formal joint training from mmp and the hunger project-malawi (thp) staff on malaria topics, such as vector biology, parasite transmission, and vector control. after training, the has were tasked with organizing and conducting village workshops in their respective villages to share knowledge on the malaria topics. they were also responsible for fostering malaria discussions, facilitating community-based implementation of larval habitat draining and filling as part of community-based lsm and coordinating all malaria control activities at village level. the lsm committees were comprised of 10 to 12 individuals from the respective village selected by members of each village at community meetings. these lsm committees were formed to carry out lsm activities in each selected village, and they were tasked with quarterly mapping of potential mosquito larval habitats, lobbying for and coordinating community participation in larval habitat draining and filling, and bti application. community members were then tasked with larval habitat draining and filling. survey instruments comprised of focus group discussions (fgds) and in-depth interviews (idis) that were developed based on points stemming from quantitative surveys conducted by the first author prior to the qualitative study. prior to commencement of data collection, data collectors were trained and the data collection tools were piloted. this was done in order to acquaint the data collectors with the purpose of the study, interview guides and consent forms, and the consenting process, table s1 and additional file 2: table s2 provide summaries of the interview guides. questions for the different interview sessions included perception of malaria as a problem, its symptoms, mode of transmission, risk factors and control, and recommendations for effective community involvement in control initiatives. questions related to the perception of malaria as a problem and knowledge about malaria transmission were restricted to idis and fgds involving the general community. twenty-four idis were conducted with members from the general community in the study villages. selection of the idi participants was based on overall village-level motivation and participation in the lsm activities. this was based on results of the quantitative surveys conducted a priori. to rank the villages, proportions of participants per village who indicated both motivation and participation in the activities were compared with the proportion of those who indicated no or little motivation and participation. then the villages were divided into two groups: (1) above average motivation and participation and (2) below average motivation and participation. twelve idis were conducted with participants from villages with above average motivation and participation, and the other twelve from the villages with below average motivation and participation. nine mixed-village fgds were undertaken with community members, has and lsm committee members drawn from different lsm villages. these did not include participants of the idis. like in the idi sessions, selection of villages from which participants would come was based on how each village ranked on the scale described for the idis. thus, for each mixed-village fgd session the participants came from villages with above average motivation and participation and below average motivation and participation. the fgds were conducted in each of the three focal areas, such that one fgd for each of the three target groups was conducted in each focal area. to stimulate discussion and ensure contribution of all members the number of participants in the fdgs was between six and eight. a consolidated criteria for reporting qualitative studies (coreq) highlighting details of methods such as the research team, study design, and analysis and findings has been provided (additional file 3: table s3 ). the idis and fgds were conducted in the local language chichewa. all data were audio-recorded, transcribed and translated into english. data was analysed thematically. the first author familiarized himself with the whole data set and the last author coded four transcripts. a common coding framework was developed through discussion. a codebook was developed using inductive and deductive coding methods. the inductive approach allowed generation of new themes emerging from the data while the deductive approach was based on a pre-developed codebook, which guided the coding process. the translated excerpts were coded using nvivo 12 (qsl international, victoria, australia). the first and last author identified key themes. the university of malawi's college of medicine research and ethics committee granted ethical approval (com-rec protocol number p.12/17/2222). permission to collect data in the study villages was provided by the chikwawa district heath office (dho). prior to recruitment of participants, communication about the study was sent to the community through local village heads in liaison with has. written informed consent was obtained from all participants during data collection. all the participants were men and women aged above 18 years. literate participants provided a signature on the consent form and illiterate participants provided a thumbprint. interviews were conducted in a private space, and participants were assured that their personal details would be omitted from transcripts and no personal details would be divulged to ensure confidentiality. finally, participants were informed that their involvement in the research was voluntary and that withdrawal was permitted at any time and without personal consequence. a total of 87 respondents participated in the 33 interview sessions: 24 idis and 9 fgds (table 1 ). all the idis were conducted with the community members that were not has or lsm committee members. three fgds were conducted per focal area: one with community members; one with has; and one with lsm committee members. most of the participants were in the age group 18 to 24 (71.3%) and reported primary education as their highest level of formal education (51.7%). more males (57.5%) than females (42.5%) participated in the interviews. the study results were grouped into five main themes drawn through the inductive and deductive methods ( table 2) . theme 1 covered topics that were only asked to the participants from the general community and not to the other groups (has and lsm committee members). results of the present study showed widespread perception of malaria as a health problem among members from the broader community. unlike the has and lsm committee members, the broader community received minimal formal training on the malaria topic. much of their knowledge came from their interactions with the has and lsm committee members who received tailored training from the larger project, mmp. the community members mentioned that their own malaria related illness, and/or illness of those close to them, reduced their performance of income generating activities and increased financial expenses via treatment and treatment-seeking activities. "when one suffers from malaria they need money to access treatment while at the same time all economic activities that would be undertaken to improve their livelihood are halted" (idi, community participant, kandeu 2) "i find malaria to be particularly burdensome because it is very hard to find medicines at the local health centres hence we are forced to buy from pharmacies at higher prices" (idi, community participant, kabwatika) although malaria was identified as a problem that affects everyone, most participants reported that pregnant women and children are most vulnerable to the disease. "much as everyone is at risk of malaria, young children and pregnant women are the most vulnerable" (idi, community participant, kampaundi). there was widespread knowledge among all respondents about the mode of transmission of malaria parasites and the type of environment conducive for breeding and development of mosquitoes. almost all respondents reiterated that bites from infected mosquitoes drive malaria transmission. interestingly, a member from the community was even able to mention the sex and genus of the mosquito responsible for the transmission of malaria. "when a female anopheles mosquito bites a person with malaria and then another person without the disease, the malaria parasite is transmitted to the latter" (idi, community participant, chipula). when asked where mosquito larvae could be found, participants provided varying responses. some participants identified natural and human-made sites and objects as potential larval habitats. particular mention was made on the duration of water storage, the nature of the water (stagnant, dirty or clean), including the container or vessel and the contents in it, as factors that contribute to where mosquito larvae are most likely to be found. the term "dirty water" was in these cases synonymous with foul water. "mosquitoes breed in standing water or in water that has been stored or has not been used for a long time" ( most participants implicated human activities with creation of the potential mosquito larval habitats. the responses provided were categorized based on purpose: (1) domestic: washing and drinking, (2) agriculture: irrigation, fish farming and watering points for livestock, (3) and construction: brick-making and mud. brick-making purposes were the most mentioned reason for creation an lsm committee member who was responsible for carrying out larviciding activities supported this opinion. "much as we know that these are the very places where mosquitoes driving malaria transmission breed, some of these places are very important to us as we use them to irrigate crops, drinking points for our livestock and also to soak bamboos for making traditional mats" (fgd, lsm committee, fa-a). despite the perceived conflict between community developments and malaria control, participants displayed an understanding of the role of these places as refuge for immature stages of mosquitoes. this enabled some of the participants to suggest solutions for malaria control. "mosquitoes breed in standing water bodies which are readily available in our villages. removing these potential breeding sites is the only sure way forward'' (idi, community participant, jana) "if we are not careful, discharging water anyhow into these swamps creates suitable environments for mosquito proliferation, a thing which can increase malaria prevalence in the area" (fgd, lsm committee, fac). most of the participants agreed on the effectiveness of bti for mosquito control. however, it was observed that some community members did not want to work with the larvicide for fear of a health risk for themselves or their livestock, especially at the onset of the project. lack of evidence of the product's activity and safety was the major reason for the skepticism and lack of trust in the product by the community. a community member highlights this perception: "i do not really know how bti works but i think it can cause cancer. because no livestock has died due to the larvicide does not mean i should not be conadditionally, some participants were initially sceptical about the product, because lsm committee members used mouth masks during application of bti. "the use of masks by members of lsm committees during bti application made some people suspicious of the product" (fgd, ha, fa-a) the initial concerns were on the safety of livestock, crops and human life, but as time passed the community members could see that bti did not have harmful effects on their crops, livestock and their personal health. increased engagement with lsm committees and has increased community trust, support and acceptance of the larvicide. "initially we had a lot of fears about bti as we thought it would be harmful to those using treated water sources but we have neither seen nor heard of any harm due to the larvicide. we are beyond convinced that this product only kills mosquito larvae" (idi, community participant, kampaundi). "we did not allow lsm committees to apply bti in water bodies, especially those used for irrigations purposes because we had fears the larvicide would cause damage. now we have realized that our fears were unfounded. we are very willing and ready to have the habitats sprayed with the product" (fgd, community members, fa-c) in some cases, field-based workshops were held with the community where bti was actually applied on habitats infested with mosquito larvae. at these sites the activity of bti on the larvae and other aquatic organisms was co-investigated with the community members. the lsm committees believed that it was only those people who did not attend community workshops who had negative concerns about the product. "the people who complained were those who never attended village workshops so they did not know the benefits of bti. once they come to understand they will never protest again" (fgd, lsm committee, fa-b) under this theme factors that motivated community participants in carrying out lsm activities were explored. enabling factors included involvement of local leaders in the initiative and the knowledge gained through workshops about malaria control and implementing control measures. most lsm committee members felt that the knowledge they attained about mosquito larval control made them aware of their role in the fight against malaria. the community members perceived a visible decline in malaria cases in their communities, which they attributed to their work. they indicated that such achievements encouraged them to work towards more reductions in the malaria burden. they also cited problems faced to access treatment for malaria as a factor driving their actions towards malaria control. "we have had the worst experiences with malaria. we live very far from health facilities hence have problems to access health care services. this initiative is our lifeline hence our great zeal to participate" (idi, community participant, kampaundi) "i am motivated to participate in the activities because our community has been very disadvantaged in terms of access to health care services. we live very far from the nearest health facility, which is also a paying facility. i fully understand the challenges faced to access medical help at the facility. so when we were told about what we are supposed to do to reduce the malaria burden i decided to participate" (idi, community participant, kandeu 2) there was a general feeling among the community members that has and lsm committee members were more motivated to participate in the lsm activities than the rest of the community. however, the community members expressed mixed sentiments as to why has and lsm committees seemed more motivated to participate in the activities. some community members felt that the knowledge the two groups gained during the course of their duties enticed them to participate in the control initiative. another section of the community felt that the money given to the two groups by mmp to meet logistical requirements for trainings outside their focal areas incentivised them. "these people work hard because they understand that the intervention would be beneficial to their communities" (idi, community participant, kandeu 2) "lsm committee members work hard because they are taken to trainings where they are given money. if there were no such incentives none of them would be as active" (idi, community participant, kampaundi idi) when asked what they felt were the limiting factors for community implementation of the lsm activities, the respondents cited a number of issues. one of the major factors cited by lsm committee members was the high amount of labour and time required to carry out bti application activities. weekly applications of bti were necessary for optimum effectiveness of the bti because of its short residual activity. however, lsm committee members reported that much of their time was spent carrying out the lsm activities, which reduced their time to participate in income generating activities for their households. "the work is too laborious. we do bti pre-and postspray surveys every week, and we spray bti after every seven days. this means we spend much of our time working in lsm at the expense of our families' well-being" (fgd, lsm committee, fa-c) they also mentioned the long walking distances to the sites where they applied bti and the continued creation of potential mosquito larval habitats. "the major problem is distance, when we go to spray bti, we travel long distances because some water bodies are very far. sometimes we plan to spray more breeding sites per day but fail to realize the plan because we have to travel long distances hence end up spraying in very few. this makes us work for more days than expected" (fgd, lsm committee, fa-c) "this work is very tiresome as we are required to continuously fill and drain, and spray bti every week in the potential mosquito breeding sites. from the look of things we will continue to create these sites as we do not have alternatives to bricks [the excavation of which creates breeding sites]" (fgd, lsm committee, fa-a) some respondents indicated that provision of no monetary incentives was a major factor influencing lack of participation in the activities. while this feeling was widespread, it was not true for some villages. "some members are discouraged because they want outright benefits. of course, in my area there have never been such cases, but i know this happens in other villages" (fgd, lsm committee, fa-c) lack of gumboots as protection from water-borne infections, for example to protect against schistosomiasis, for each committee member was the most cited challenge. while acknowledging the provision of several pairs of gumboots by the project, they noted that these were not sufficient for all committee members. they also indicated their reluctance to share boots due to risk of contracting foot-borne fungal infections. "we do not have enough gumboots for all members of the committee. we were told to be sharing the few we have but we cannot do that for fear of athlete's foot" (fgd, lsm committee, fa-a) some lsm committee members cited the indifference of some community members towards lsm as a demotivating factor. respondents noted that some community members did not attach value to the work of committee members and demeaned their volunteerism. this indifference left some lsm committee members frustrated, and in some cases led to dropping out from the committees. "we are often discouraged by poor remarks from some members of the community despising our volunteerism" (fgd, lsm committee, fa-b) " we are called stupid and time wasters by some community members for volunteering to work in this project" (fgd, ha, fa-c) there was a widespread perception among the respondents that village heads were not fully involved in the ongoing lsm activities. the respondents suggested that for increased community participation in the activities the village heads needed to receive training and be tasked with specific roles. some participants recommended that for future or for scale-up of existing community-led initiatives, groups comprised of village heads should be created to monitor the activities locally. "a team of village heads should be instituted which should be tasked with monitoring lsm activities at village level. they should receive the same training as lsm committees. these people are highly respected by communities, which could ensure high community participation in the lsm activities. this team should be constantly updated by has and lsm committees" (fgd, ha, fa-c) . some participants also recommended restructuring lsm committees by removing non-active members to improve group performance, adding more members to existing committees to reduce member work-load, or by making the selected committees work for a fixed period after which new committees take over. the participants also recommended need for constant feedback on how the intervention is progressing. they felt this could encourage their participation in the activities. "the community should be given feedback on how the intervention is performing. this could motivate them" (fgd, ha, fa-a) lastly, continued community sensitization was reported to be paramount if buying-in and participation in the lsm activities were to be successful. "there is need for continued sensitization meetings. it is through repeated messages that some people change their attitude" (fgd, ha, fa-a) findings of the present study show that community involvement in lsm increased awareness of malaria as a health problem, its risk factors and control strategies. lack of incentives as observed in other research paradigms in malawi [28] reduced participation of members from the broader community in the activities. support from community leaders was a critical factor for community participation in the activities. labour intensiveness, the time-demanding nature of the activities, and fears about health risks associated with working in water bodies, created barriers to successful implementation of the intervention by the lsm committees. these results suggest that a wide range of factors must be considered for optimum effectiveness of community-driven malaria interventions. participants in the present study perceived malaria as a health problem prevalent in their communities and recognized children and pregnant women as groups most vulnerable to the disease. participants were aware of the role of mosquitoes in transmitting the malaria parasite and had knowledge of potential mosquito larval habitats. this knowledge is attributable to the malaria workshops conducted by the has in each village. previous studies have suggested that community awareness of malaria as a burden has the potential to trigger positive action towards malaria control [29, 30] . at the time of the present study, the results of the intervention trial [25] were not yet available, and hence in the preparatory meetings with communities, as well as during the refresher courses for health animators and local leaders, participants were reminded of the possible outcomes: no impact on malaria, medium impact on malaria or strong impact on malaria. local communities needed to be encouraged to continue with the interventions which in the end might benefit them. in this study, the communities understood the association between mosquito larval habitats and malaria. however, some water bodies served a specific function in the community and were deemed useful by the respondents. this presents potential limitations in the adoption of habitat draining and filling for malaria control. similar observations were made in kenya where perceived importance by the community of some water bodies limited their willingness to remove such sites [31] . where habitat draining and filling are not feasible, application of larvicides is a viable alternative [9] , and this was widely practiced by the communities in this study. the use of other lsm strategies such as predatory fish or shading of the breeding sites with plants such as napier grass or coco-yams to make such sites less suitable for malaria vector mosquitoes has also been suggested [32] . community perception of bti as a mosquito control tool improved with increased engagements with has and lsm committees, and interaction with the product. initially, the communities reported skepticism about the product over potential harmful effects to humans, livestock and crops. the lack of a befitting synonym for the word "pesticide" when referring to bti in the participants' vernacular, chichewa, confounded their fears of the product. in chichewa, the word "pesticide" is loosely interpreted as "poison" which denotes an inherent element of side effects. through community workshops and handling of the product in the field, the community learned about the product's activity and specificity, which resulted in improved acceptance of the product by the community. similar observations were made in rwanda where acceptance of bti was observed to improve with increased interaction with the product by rice farmers tasked with its application [33] . the findings suggest that for meaningful acceptance of control strategies, community training should focus on approaches that build trust by demonstrating the safety of the products to non-target organisms. the has and lsm committees were more motivated to participate in the lsm activities than the members from the community at large. according to the has and lsm committees, attainment of knowledge of malaria and its control, and their sense of 'duty' motivated their participation in the lsm activities. for the both groups, the status received in the community for their role made them feel valued and motivated. however, some members from the broader community felt that the motivation of the has and lsm committees was a result of the "monetary incentives" they received during their trainings. this could be justified by the frequent calls made by the lsm committees for refresher trainings. this could potentially pose a barrier in community participation in the intervention as observed in another study conducted in malawi where receipt of incentives by some groups demotivated other groups [34] . similarly, in a sub-study conducted under mmp in the same area as the current study "monetary incentives'' received by the has during their trainings were feared to have weakened the sustainability of the health animator approach [35] . indeed, the forms and modes of delivery of incentives in volunteerbased initiatives are critical but they remain less studied [36] . in kenya, adaptation of a malaria control intervention (odour-baited mosquito traps) to local context by providing a source of solar energy to householders increased community acceptance and uptake of the intervention [37] . based on these findings, incentives have a role in influencing acceptability, uptake and sustainability of community-led interventions. to increase interest of a community and motivation to participate, the intervention agenda should be developed in light of the local contexts, with enhanced attention for the community's needs. participants considered lsm activities to be labour intensive and time consuming, especially larviciding with bti, which required weekly application. some lsm committee members felt that the demands of the activities prevented them from actively engaging in income generating activities for the betterment of their livelihoods. the findings underscore the need to incorporate technical solutions that increase intervention coverage and quality while reducing labour demands. these technical solutions include powered sprayers, drones, and remote-sensing based risk maps [38, 39] . in the present study, it was evident that local leadership was needed for effective implementation of the community-led lsm activities. a hierarchical structure with village heads, has and lsm committees as leaders was regarded as supportive by most of the respondents. this finding suggests that local authorities should not be engaged for administrative purposes only but also in both planning and implementation of community-led initiatives. the findings also suggest that the village heads should work closely with lsm committees and has, with the latter groups only addressing the operational aspects and not the village politics such as calling for community workshops. importantly, interventions should capitalize on the existing traditional structures present in each community. rural communities have strong social structures resulting from their communal living [31] which, if exploited, could make community engagements attainable. the variable participation of members from the broader community reported in the present study likely resulted in lower coverage of lsm than was targeted. though not measureable in the absence of intervention because the fgds did not include an external control group, the community's high level of knowledge about malaria as a health problem and its transmission is presumably due to the educational intervention of mmp. this suggests that the conception and design of the intervention were effective. community involvement in lsm as an additional tool for malaria control increased local awareness of malaria as a health problem, its risk factors and control strategies. however, community participation varied among the respondent groups, with labour and time demands of the activities, and lack of financial incentives, among the reasons cited for reducing participation. employing innovative tools with potential to reduce labour and time demands could improve community participation in the activities. further studies are required to investigate the forms and modes of delivery of incentives in operational community-driven lsm interventions. the effect of malaria control on plasmodium falciparum in africa between impact of pyrethroid resistance on operational malaria control in malawi a cohort study of the effectiveness of insecticide-treated bed nets to prevent malaria in an area of moderate pyrethroid resistance, malawi how to contain artemisinin-and multidrug-resistant falciparum malaria escalation of pyrethroid resistance in the malaria vector anopheles funestus induces 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biomedical research participation in blantyre district, malawi communitybased environmental management for malaria control: evidence from a small-scale intervention in dar es salaam impact of education on knowledge, agricultural practices, and community actions for mosquito control and mosquito-borne disease prevention in rice ecosystems in sri lanka an exploratory survey of malaria prevalence and people's knowledge, attitudes and practices of mosquito larval source management for malaria control in western kenya malaria vector control: current and future strategies community-based biological control of malaria mosquitoes using bacillus thuringiensis var. israelensis (bti) in rwanda: community awareness, acceptance and participation optimising the benefits of community health workers' unique position between communities and the health sector: a comparative analysis of factors shaping relationships in four countries the role of health animators in malaria control: a qualitative study of the health animator (ha) approach within the majete malaria project (mmp) in chikwawa district sustainability of intervention for home management of malaria: the nigerian experience options for sustaining solarpowered mosquito trapping systems on rusinga island, western kenya: a social dilemma analysis utilization of combined remote sensing techniques to detect environmental variables influencing malaria vector densities in rural west africa disruptive technology for vector control: the innovative vector control consortium and the us military join forces to explore transformative insecticide application technology for mosquito control programmes publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations we thank all the research assistants for their support in data collection. davies kazembe, happy chongwe, asante kadama, richard nkhata and tinashe tizifa are thanked for logistical support. we also thank the study population for their willingness to participate in the study. supplementary information accompanies this paper at https ://doi. org/10.1186/s1293 6-020-03268 -8. additional file 1: table s1 . interview guide (fgd) for community members, has and lsm committees.additional file 2: table s2 . interview guide (idi) for community members.additional file 3: table s3 . a coreq checklist highlighting details of methods.authors' contributions sg, rsm, wt, hb and ltm conceived the study design. sg collected the data. sg, lmt and hb contributed in the data analysis. sg, rsm, cjmk, wt, hb and lmt participated in interpretation of the results. sg drafted the manuscript. all authors read and approved the final manuscript. de vos fund, the netherlands, generously supported the study. we also thank the dioraphte foundation for some financial support. rsm received additional support from an nih-funded postdoctoral fellowship (t32ai007524). the content is solely the responsibility of the authors and does not necessarily represent the official views of the funders. data can be made available upon reasonable request. the study was approved by the university of malawi's college of medicine research and ethics committee (comrec) under certificate number p.12/17/2222. written informed consent was obtained from all participants during data collection. not applicable. the authors declare that they have no competing interests. key: cord-035289-m3uvh8zn authors: fabbricatti, katia; boissenin, lucie; citoni, michele title: heritage community resilience: towards new approaches for urban resilience and sustainability date: 2020-11-11 journal: city territ archit doi: 10.1186/s40410-020-00126-7 sha: doc_id: 35289 cord_uid: m3uvh8zn the value of cultural heritage and its transmission for “making cities and human settlements inclusive, safe, resilient and sustainable” is an integral part of the un agenda 2030 and the new international policy for disaster risk reduction 2015–2030. nonetheless, the role of culture for these important challenges is an issue that current scientific literature on resilience has not yet sufficiently investigated. starting from the concept of heritage community, elaborated in the council of europe's framework convention on the value of cultural heritage for society (framework convention on the value of cultural heritage for society, 2005), along with the hypothesis of its role for community resilience, this study elaborates a conceptual framework in which “heritage community resilience” is defined. it is both a target and a process in which cultural heritage supports the building of a community able to prevent, cope with and recover from disturbances and/ or disasters. through a survey of several case studies on heritage-driven practices in italian inner peripheral areas, the research aims to define the specific characteristics of heritage community resilience as well as identify any critical actors and variables, strategies and governance mechanisms, which influence both heritage community and community resilience. it predicts the challenges and highlights the potential that culture and heritage can develop for community resilience, towards further perspectives of resilient circular city. cities now have to face various types of risks, including frequent or infrequent events, with either sudden or slow-onset natural or man-made hazards, that can occur both globally (climate crisis, scarcity of resources, migrations, etc.) and locally (earthquakes, depopulation, erosion of cultural capital, etc.). urban resilience is an international topic of discussion (pu and qiu 2016) in global policy frameworks (unesco 2013 (unesco , 2015 undrr 2015a; undrr 2015b) . nonetheless, urban resilience still has a low profile in some policy arenas (chmutina et al. 2016) , with cities being far from reaching the goals set by international programmes or standards, as the current covid-19 pandemic seems to confirm at a global scale, even though the available data are still partial and contradictory. in the governance debate, community resilience is developing into an autonomous theme (coaffee 2013; mulligan et al. 2016; chelleri et al. 2016) . it is becoming a target for society development for both scientific literature (berkes and ross 2013; chaskin 2008; cutter et al. 2008; maguire and cartwright 2008; etc.) and national security policies (uk community resilience programme, us community resilience taskforce, australian national strategy for disaster resilience, etc.) . in recent years, communities are demanding and gaining autonomy to address deficiencies in development policies. the community is an integral part of social-urban and socio-ecological systems, with it represents the most dynamic part fabbricatti et al. city territ archit (2020) 7:17 of them. therefore, resilience must be pursued on the community scale (longstaff et al. 2010) . recent global policy documents (unesco 2013 (unesco , 2015 undrr 2015a; undrr 2015b) link community resilience to the strengthening of culture and cultural heritage. for the first time in 2013, cultural heritage was recognised as an important "actor" in addressing global risks, especially for its role in strengthening cr (unesco 2013, action 6) . the session "resilient cultural heritage" of the third united nations world conference on disaster risk reduction (wcdrr) (undrr 2015b) stressed how any disaster risk reduction policies and programmes should consider the cultural context, including cultural heritage as its most symbolic manifestation, if it is to be effective and sustainable. in resilience debates, however, this is an issue that current literature has largely failed to contemplate (beel et al. 2017) . the council of europe's framework convention on the value of cultural heritage for society (council of europe 2005, art. 2b) shifts attention from the cultural heritage in itself towards people and their active participation in the process of recognizing the values held in it and their transmission to future generations (council of europe 2018). it defines "heritage community" as a community that "values specific aspects of cultural heritage which it wishes, within the framework of public action, to sustain and transmit to future generations" (council of europe 2005, art. 2b). a heritage community is characterized by awareness of the resource value of its cultural heritage, a sense of belonging, inclusiveness, collaboration at all levels, a common interest in heritage-led actions, shared civic responsibility towards cultural heritage. based on the role of culture and cultural heritage in relation to community resilience, this study elaborates a conceptual framework in which "heritage community resilience" is considered as being both a target and a process in which cultural heritage supports the building of a community able to prevent, cope with and recover from disturbances. in an evolutionary vision of resilience, in which communities do not return to an initial state but evolve (davoudi et al. 2012; pink and lewis 2014; hillier 2015; etc.) , culture and cultural heritage can be the key to citizen engagement (idea of common good), as well as to social, environmental, economic and governance innovation. through a survey of several case studies on heritagedriven practices, the research aims to: define the specific characteristics of heritage community resilience; identify the effects of the practices for building heritage community and community resilience processes; define critical actors and variables, strategies and governance mechanisms, which influence both hc and cr. european peripheral areas, with particular attention to alta irpinia in southern italy, represent the research context. here, recognition and promotion of culture and creativity are particularly critical challenges. in these contexts, culture and creativity can help maximise economic returns from the production of place-specific and high-value-added products, favouring citizen engagement and community building (european commission 2017) . from the lessons learned in the case studies in alta irpinia, the research predicts the challenges and highlights the potential that culture and heritage can develop for community resilience. the paper is articulated as follows: first, the concept of cr is discussed within the international debate on resilience, with a focus on culture and cultural heritage; then the conceptual framework of the research is presented; in the second section, the survey method of the case studies is defined and then the research context is presented; finally, the cases are described and discussed. community resilience is an increasing target for social and urban development, as scientific literature (berkes and ross 2013; chaskin 2008; cutter et al. 2008; maguire and cartwright 2008; sharma and verma 2019; etc.) , international documents (unesco 2013 (unesco , 2015 undrr 2015a; undrr 2015b) and some agency and state strategies declare (bach 2015; mulligan et al. 2016) . the assumption of a social component, within the original ecological resilience approach, started in the late 1990s, with a progressive enrichment of both social and ecological domains. "the social-ecological understanding of resilience emerged with the assumption that social and ecological systems were inextricably interconnected and that local communities could be made more resilient to unexpected shocks if efforts were made to increase their adaptive capacity" (mulligan et al. 2016, p. 3) . the latter is a property of the social-ecological system, with it distinguishing humans from animals and plants; the former can anticipate change and together with social, political and cultural experiences influence resilience (folke et al. 2010 ). communities do not control all of the conditions that affect them, but they can change some of the conditions that can increase their resilience (berkes and ross 2013) . as some authors have pointed out (mulligan et al. 2016; berkes and ross 2013; etc.) , although the approach to resilience significantly benefited from social-ecological cross-fertilization, the word "community" continued to be used rather uncritically. the causes highlighted by the authors are related to the socio-ecological approach, developed in fields such as biophysical or environmental sciences and resource economics rather than in sociological or cultural studies. a significant contribution to the evolution of the concept of community resilience comes from the field of psychology. in berkes and ross' research on the mental health and developmental psychology (berkes and ross 2013) , resilience is defined as a process of dynamic personal development in the face of adversity and adaptation, rather than as a stable outcome that is achieved and then retained (luthar and cicchetti 2000; almedom et al. 2007) . the extension of this study to the community scale focuses on identifying the strengths of a community, and how they contribute, in a collective process, to facing challenges and developing resilience (kulig et al. 2008; berkes and ross 2013; norris et al. 2008; buikstra et al. 2010; etc.) . several studies agree that the main strengths of a community are: individual psychological components-social networks, social inclusions, sense of belonging, leadership, outlook on life, learning (norris et al. 2008; kulig et al. 2010; buikstra et al. 2010; etc.) , the natural and built environment they are aware of, the lifestyles and livelihoods, where the role of infrastructure and support services are particularly important in disaster recovery (kulig et al. 2008) . in applied uses of psychological resilience thinking, it is important to highlight how human beings can train resilience through their responses to shocks and stresses, and actively develop resilience through capacity building and social learning (goldstein 2009 ). in the evolution of the issue of community resilience, scholars agree that some of the greatest progress has been made in urban planning, bringing together community and resilience in a meaningful way. in the urban context, as a complex adaptive social-ecological system, "a sophisticated understanding of both socio-ecological systems and the more cultural and political conceptions of the community" emerge (mulligan et al. 2016, p. 5) . in the field of urban studies, the evolutionary perspective of resilience (davoudi et al. 2012; pink and lewis 2014; hillier 2015) is "understood not as a fixed asset, but as a continually changing process; not as a being but as a becoming" (davoudi et al. 2012, p. 304) . to the interpretation of resilience as "dynamic interaction of persistence, adaptability and transformability on multiple scales" introduced by folke et al. (2010) a fourth component "preparation", based on learning ability has been added, which reflects "the intentionality of human action and intervention" (davoudi et al. 2012) . this is typical of social systems, enhancing the key role of social capital and institutions in the building up of resilient cities (galderisi 2018) . the ability of people to learn from experience, to increase their abilities to prepare, cope with and recover from disturbances is therefore the basis for community resilience. bulley (2013) noted that communities need to be 'produced' before they can be mobilized. rather than a static and vulnerable entity, communities are therefore as complex assemblages 'making' resilience at, across and between local and global scales (pink and lewis 2014) . community resilience is therefore not a target but a dynamic process based on continuous learning (cutter et al. 2008; wilson 2014) . in recent years, strengthening community resilience has emerged as an essential element of national security policies to address climate change and risks (bach 2015; mulligan et al. 2016) . in 2008, the uk government launched in 2008 a cr programme and published in 2011 the strategic national framework on cr, which "is intended to provide the national statement for how individual and community resilience can work", and "should be relevant to all hazards and threats, and all communities" (uk cabinet office 2011). in the usa, the federal emergency management agency considers community resilience as one of the "core capabilities" needed to achieve the "preparedness" for all types of disasters and emergencies (fema 2015) . the entire strategy is based on a "whole community" approach (fema 2015) , which aims to engage society at all levels: "the core value proposition of this whole community approach is that by strengthening the assets, capacities, relationships and institutions within a community before disasters strike the community will prepare more effectively, better withstand the initial impacts of an emergency, recover more quickly, and adapt to become better off than before the disaster hit" (kaufman et al. 2015, p. 158) . some other examples are worth mentioning, like the australian national strategy for disaster reduction, 2011, that of new zealand after christchurch earthquake, and the netherlands which experimented a "living with the water" approach that involved a publicprivate cooperation to face the growing climate threats (goemans et al. 2015) . as mulligan noted, these national community resilience policies and programmes assume that more resilient local communities will make for a more resilient national community (mulligan et al. 2016) . some of the above mentioned strategies, such as the australian and us, point to cultural heritage as one of the assets that people prepare to protect in a disaster resilient community. however, there is still little reference in these programs to the role of cultural heritage in building community resilience. indeed, only recently, the debate on resilience has been enriched by the emerging issues related to culture and cultural heritage. in particular, the topic is addressed in some global policy documents (unesco 2013 (unesco , 2015 undrr 2015a) and is being discussed in further detail in current scientific literature (jigyasu 2013; holtorf 2018) . in 2013, for the first time in international documents, cultural heritage was recognized as playing a role in addressing global risks, especially for its ability to strengthen community resilience (unesco 2013). in the hangzhou declaration, placing culture at the heart of sustainable development policies, "the appropriate conservation of the historic environment, including cultural landscapes, and the safeguarding of relevant traditional knowledge, values and practices, in synergy with other scientific knowledge, enhances the resilience of communities to disasters and climate change" (unesco 2013, action 6). later, during the third united nations world conference disaster risk reduction (wcdrr), in which the sendai framework for drr 2015-2030 was adopted, it was recognized that "cultural heritage provides important insights and opportunities for enhancing disaster risk reduction, post-disaster rehabilitation and recovery, building back better and for stimulating local economic and social development» (undrr 2015a). the session on "resilient cultural heritage" highlighted how any disaster risk reduction policies and programmes should consider the cultural context, including cultural heritage as its most symbolic manifestation, to be effective and sustainable (undrr 2015b). in the 2030 agenda for sustainable development (unesco 2015) and the new urban agenda (un 2016), culture emerges as a transversal driver, both as a knowledge capital and source of creativity and innovation, as well as a resource to face challenges and find appropriate solutions. "culture is who we are, and what shapes our identity. placing culture at the heart of development policies is the only way to ensure a human-centred, inclusive and equitable development" (hosagrahar et al. 2016 ). in the document of the un conference on housing and sustainable urban development habitat iii (un 2016), it is stated that culture allows to revitalize urban areas, strengthens social participation (point 38) and contributes to developing vibrant, sustainable and inclusive urban economies (points 45 and 60). in scientific debates, the question of the relationship between heritage and resilience is spreading and evolving, although the debate is still sectoral (beel et al. 2017) . in most cases, the issue is addressed starting from the need to safeguard cultural heritage, recognizing its important role for the well-being and quality of life of people (azadeh et al. 2015; etc.) . some studies carried out as a result of the analysis of the processes that occurred before and after the disasters, have highlighted the contribution of the local material culture in prevention and recovery from risks. in the prevention phase, for example, the role of knowledge of traditional construction techniques or traditional prevention strategies resulting from subsequent trial and error in the management of known and expected risks is underlined (jigyasu 2013; d' amico and currà 2014; boccardi 2015; etc.) . a recent paper by holtorf (2018) , unesco chair on heritage futures in sweden, suggests an approach to cultural resilience (crane 2010) in which cultural heritage promotes resilience "precisely through the way, often highly evident, in which it has been able to adapt and develop in the past" (holtorf 2018, p. 647) . in this article, the author suggests that cultural resilience, risk preparedness, post-disaster recovery and mutual understanding between people will be better enhanced by a greater capacity to accept loss and transformation. in the author's view, the visible changes in cultural heritage over time can inspire people to embrace uncertainty and absorb adversity in times of change, thus increasing their cultural resilience (holtorf 2018) . the present research proposes new elements for the debate on the role of cultural heritage for resilience, and in particular for community resilience, with the concept of "heritage community resilience". the paper focuses on the capacity of cultural heritage to make and innovate communities (council of europe 2005), in a proactive process aimed at preventing, coping with and recovering from disturbances and/ or disasters. the framework convention on the value of cultural heritage for society (council of europe 2005) marks a revolution in the meaning of cultural heritage, shifting the attention from objects and places to people: "cultural heritage is a group of resources inherited from the past which people identify, independently of ownership, as a reflection and expression of their constantly evolving values, beliefs, knowledge and traditions. it includes all the aspects of the environment resulting from the interaction between people and places through time" (art. 2a). this new way of looking at heritage lays the foundations for redesigning relations between all the involved stakeholders. it stresses the crucial role of inhabitants and, as suggested by the convention, of a real "heritage community" (art. 2b). the faro convention approach empowers communities to take an operational role in decision-making towards direct democracy as well as contribute to the defining of policies and strategies regarding their local resources. heritage communities are defined as "people who value specific aspects of cultural heritage which they wish, within the framework of public action, to sustain and transmit to future generations" (art. 2b). in the aim of the convention, heritage communities are self-organized and self-managed groups of individuals interested in a progressive social transformation of relations between peoples, places and histories. they have an inclusive approach based on a better definition of heritage. fabbricatti et al. city territ archit (2020) 7:17 the principles upon which the convention is based are listed in the action plan: -"connection to a community and territory determines a sense of belonging; -social cohesion is founded on various levels of cooperation and commitment; -democracy is practised through the engagement of civil society in dialogue and action, through shared responsibilities based on capacities" (council of europe 2018, p. 6). the convention thus marks a definitive passage from the "right of cultural heritage" to the "right to cultural heritage", progressing from a static idea of the "value in itself " of cultural heritage towards a proposition of "relational value", which links in an interactive, dynamic and complex way "people and places through time" (art. 2b). heritage communities are the testimony and vehicle of local identity values to preserve and transmit to future generations. they are also "cultural" laboratories, drivers of inclusive actions, collaboration at all levels, of heritage-led actions, shared civic responsibility towards cultural heritage. for the purposes of this research, the attributes of a hc can be summed up in: awareness of the value of its cultural heritage resources, sense of belonging, inclusiveness, collaboration at all levels, common interest in heritage-driven actions, shared civic responsibility towards cultural heritage (council of europe 2018). the research hypothesises that these attributes can support community resilience at different stages of its life (asprone and manfredi 2015) , and in particular in disaster risk reduction. in this hypothesis, the research develops a conceptual framework in which it defines "heritage community resilience". it represents both an objective and a process in which the community builds, through cultural heritage, its capacity to anticipate and adapt to the challenges and stress factors encountered before, during and after a disaster and/or disruption. in the prevention and protection phase, heritage community resilience is characterized by strength in terms of identity and recognisability, ethics, knowledge; it acts in reducing vulnerabilities through community care and maintenance of cultural heritage; it is also characterized by creative and innovative strategies and policies for disaster risk reduction. in the reaction and recovery/adaptation phases, hcr is characterized by a sense of belonging that is a powerful catalyst for the involvement of the local population; it allows for rapid recovery through income generated in the informal sector and in tourism activities, through creative and innovative cultural adaptation solutions. this new vision of community entrusts a shared responsibility of all the actors towards heritage, implicitly imposing shared policies among institutions, sector experts, national authorities (d' alessandro 2015). this is a fundamental principle of "cultural democracy" (ibidem, p. 82), which transfers responsibility to the same subjects that determine the meaning and value of the patrimonial elements with which they identify. recent global policy frameworks underline that the assumption of cultural heritage in disaster risk reduction requires enlargement and differentiation of the arena of actors, towards innovative partnerships between the heritage sector, on one hand, and the wide range of drr stakeholders, including local governments, humanitarian organizations and the private sector (undrr 2015a). it is underlined also the role of educational and research institutions in supporting the various actors in the different phases (undrr 2015a, art. 36b). on these bases, this paper aims to identify the critical actors and variables, strategies and governance mechanisms that influence heritage community resilience, in a self-sustaining circuit in which heritage community care actions can reduce the vulnerability of cultural heritage and community, and at the same time increase its capacity to prevent, cope with and recover from disturbances and/or disasters. the research method was a case study survey. the objectives of the survey were to elaborate in greater detail the characteristics of heritage community resilience, to define the effects of the practices for building related heritage community and community resilience processes, identify the critical actors and variables, strategies and governance mechanisms influencing hcr. for these purposes, the research analysed heritage-driven as well as both bottom-up or mixed bottom-up and top-down practices. the method was based on direct surveys, carried out through widely distributed questionnaires and interviews with selected stakeholders. these surveys were conducted through a previous definition of the heritage community resilience indicators that guided the collection and interpretation of data. the research methodology was based on the following steps ( fig. 1) : -definition of hcr attributes and indicators, based on sector literature about heritage community and community resilience, and their explanation in the form of questions to answer with "yes", "no", "maybe"; -selection of heritage-driven practices; fabbricatti et al. city territ archit (2020) 7:17 -diffusion of the questionnaire, based on the previous indicators, and its submission to the "community" of the practices through mailing list and paper distribution; -selection of the stakeholders involved in the practices and their direct interview; -elaboration of the results, subsequent dissemination and verification. the first phase defining the heritage community resilience attributes and indicators was carried out analysing, in literature, assessment tools of both the issues heritage community and community resilience. regarding the first issue, the faro convention action plan 2018-2019 (council of europe 2018) defines the attributes of what makes a hc. in particular, the action plan formulates 12 criteria to self-assess, self-monitor and self-evaluate the activities of the faro convention network good practices. these criteria are inspired by values of social inclusion, human rights and community well-being (council of europe 2018). unlike the heritage community, many scientific studies develop the characteristics of community resilience (maguire and hagan 2007; cutter et al. 2008; berkes and ross 2013; chelleri et al. 2016; rapaport et al. 2018; etc.) . some of them develop real evaluation systems (magis 2010; longstaff et al. 2010; wilding 2011; maclean et al. 2014; etc.) that vary in relation to the objectives and risks faced by the community. to provide a framework for the survey, we started from the six attributes of community resilience proposed by maclean et al. (2014) , previously tested in berkes and ross (2013) . these attributes emerge from a collective research in which the authors analysed a series of communities that successfully adapted to rapid and oftentimes crises-driven changes, deducing the key factors for the success. based on these six attributes, 23 indicators of heritage community resilience were formulated for the construction of a survey questionnaire (fig. 2) . in our research, these indicators are able to assess the resilience of a heritage community, so as defined in our conceptual framework, i.e. both an objective and a process in which the community builds, through cultural heritage, its capacity to anticipate and adapt to the challenges and stress factors encountered before, during and after a disaster and/ or disruption. the first attribute concerns "knowledge, skills and learning" defined as "individual and group capacity to respond to local needs and issues" (maclean et al. 2014, p. 149) . these can include practical knowledge but also soft skills like management and communication. in our hypothesis, culture can support and consolidate the process of developing this individual and collective capacity (fig. 2) . the second attribute is about either "community networks" or the existence of collective activities and projects in which community members participate, thus strengthening the links between themselves and creating common interests. in our hypothesis, the diversification of networks and actors is critical in the construction of social capital. at the same time, cultural associations can play a central role inside and outside the heritage community. the third attribute is called "people-place connections". in order to become more resilient, community members must have a "close connection to their biophysical environment" (ibidem, p. 150), which means they can take advantage of their resources, but they also have to stand for their protection and care. in our hypothesis, heritage community resilience combines adaptive capacity with a strong identity and sense of belonging; cultural heritage can sustain this process in creative and innovative ways. the fourth attribute relates to "community infrastructure". inhabitants should have access to a set of services that guarantee their basic needs (water, food, health care, mobility, education, entertainment, etc.). in particular, lifestyles and livelihoods, infrastructure and support services are crucial for the recovery from disturbances and/or disasters (kulig et al. 2008 ). in our hypothesis, when measuring this attribute, cultural services as well as tourism services and green infrastructures must be taken into account. the fifth attribute concerns the ability of the community to build a "diversified and innovative economy". it considers that the survival of the community depends not on a single but rather on multiple resources. at the same time, it recognises the need to keep up with changing market needs, as well as change in general, as an opportunity for new and diverse jobs. finally, the last attribute concerns the existence of an "engaged governance" with a "genuine participation from relevant private, public and community sector stakeholders" (maclean et al. 2014, p. 152) in problem solving and in decision-making. in our hypothesis, it implies that the governance systems include both all the actors who wish to be involved as well as those who are directly impacted by the decisions. moreover, since one of the characteristics of a heritage community is the commitment to principles of human rights in local development processes, it has been included among the indicators (fig. 2) . after a phase of selection of heritage-driven practices, a questionnaire was elaborated, based on the previous indicators, and disseminated to the "community" of each practice. each question was formulated as follows: "do you think the practice contributed to…" and completed by each indicator. three possible answers were offered: "yes", "no" and "maybe". the questionnaire was distributed to about 500 people through a general mailing list and paper distribution in places of aggregation. in addition, during the dissemination of the questionnaire, a series of semi-structured interviews were conducted with the stakeholders. they were representatives of the institutions and the main actors involved in the practices. the 17 interviews lasted between 30 and 90 min, and focused on six main open themes: the origin of the project and the reason of their involvement, the project timeline, the role the interviewee play in the event, the stakeholders with whom the interviewee cooperated, the management of the event, and the results on the territory and on community everyday life. they represented a necessary support for the interpretation of the results obtained through the questionnaire. for the data analysis concerning the questionnaire, the answers were classified according to the five categories of respondents: institutions (also including administration, trade associations, etc.), actors involved in the event management (creators, organizers, designers, artists, volunteers), partners, such as entrepreneurs and traders, residents in the municipality of the event, residents in the region or occasional tourists. the classification was necessary since not all the actors have equal information about the event. the actors involved in the management of the event have a detailed knowledge of its functioning and experience in decision-making systems, while residents and tourists are better able to express themselves on the sustainable improvements generated by the events on the community. for data interpretation, graphs were made that show the contribution of each practice to the six attributes, by category of actor (figs. 7, 8 and 9). a final graph (fig. 10) summarizes and compares the results of the three previous tables through a prior weighting of the sample, according to the number of responses contained in each category of actors. the research context is that of the internal european peripheral areas, with particular attention to an area of southern italy: alta irpinia (in the region of campania, italy). this area is composed of 25 municipalities covering 1.118 sq.km., with a population of approximately 65.000 inhabitants. it was selected as one of the 72 pilot areas of the italian strategy for internal areas (snai), launched in 2012 by the italian minister for territorial cohesion with the main aim of reversing demographic trends. in the classification of the strategy, this area is composed by peripheries and ultra-peripheries, defined as areas "very diversified within themselves, far from large agglomeration and service centres and with unstable development trajectories but nevertheless with resources that are lacking in central areas, with demographic problems but also highly polycentric and with strong potential for attraction" (territorial cohesion agency 2014). this definition tends to overcome the traditional dichotomy between cities and countryside or between mountain and coastal cities, to underline, in accordance with the european definition of peripheral inner areas, "the degree of disconnection of these areas with neighbouring territories and the network, and not (or not only) their geographical position with respect to the centres" (espon 2017) (fig. 3) . the resilience approach for these areas allows to interpret the dynamics of reaction and adaptation to local and global risks (depopulation, reduction of employment and sustainable land use, landscape degradation-caused, in turn, by hydrogeological, seismic, anthropogenic, environmental risk conditions); at the same time, it allows to define factors, endogenous and exogenous, that can influence these dynamics and can enable and facilitate changes. in addition, this approach makes it possible to define the thresholds of the variables that guide these processes, which in contexts for different aspects very vulnerable -built environment with "simple" qualities, collective memory entrusted to an aged population, natural and agricultural landscape unprofitable, etc.-can lead to trade-offs and cause irreversible changes. for the purposes of our research, inner peripheral areas represent an interesting laboratory to investigate the role of heritage communities for community resilience, and more generally to study in greater detail the characteristics of the resilience process, along with the role that the community and institutions can play in it (pike et al. 2010) . european peripheral areas share a set of common characteristics that are both the cause and result of their remote nature (pezzi and urso 2016) ; poor access to services of general interest and to job and education opportunities, limited market access of local actors, emigration of skilled people, ageing population with the need of appropriate infrastructures and services, low accessibility in terms of both transport and communication systems (digital divide), high socio-cultural capital linked to peculiar material and immaterial heritage, high air and water quality. in this context, which has been characterised by high state intervention and exclusion from networks and political power in the decision-making process, the issue of governance is crucial (herrschel 2012; pezzi and urso 2016). therefore, remoteness generated both the conditions that have determined the ability of these areas to adapt, which today represent the potential conditions for increasing their resilience. european peripheral areas preserve almost intact their material culture (robustness) and have a "latent territorial capacity", also linked to their immaterial culture, that offers high potential for innovation (adaptive capacity) (pinto et al. 2018) . in this cultural context, in recent years, either bottomup or mixed bottom-up and top-down experiences have been developed and intensified. many of these, starting from the rediscovery of values of local heritage have experimented the creation of opportunities for work, leisure, networking, research, etc. these experiences are carried out by different actors-residents, returnees, new inhabitants, tourists, volunteers, etc.-who have designed from time to time new community formations; at the same time these are characterized by innovative decision-making and management processes and new interactions with traditional institutions (magnaghi 2018; pinto et al. 2018 ). this research analyses three cases of cultural and creative practices in the single territorial context of alta irpinia (in campania, italy). several issues are weakening this area. first of all, the depopulation process: between 2001 and 2011, the population decreased by 5.8%, exceeding both the regional (1.4%) and the national (2.3%) average for non-core areas (elaboration of istat data, istat 2011). the main cause is the out-migration: people leave the territory to find working opportunities somewhere else. the second weakness, which is connected to the first one, is the ageing of the population. the 'over 65' represents about 30% of the population of the area (istat 2011). the third main weakness is the erosion of the cultural capital and the territorial identity, which are mainly challenged by external pressures on local resources: the landscape is frequently threatened by wind turbines, oil drilling and landfill projects. the change in agricultural land use represents for the resilience theory a so-called trade-off, caused precisely by the loss of value of agricultural land. the first practice analysed is the sponz festival (fig. 4) , which is held every august since 2013, in the municipality of calitri. the artistic direction is provided by the singer and composer vinicio capossela, who works closely with a local association called "sponziamoci" to organize the festival. together with the municipality, they are the main protagonists of the management of the event. their shared objective is to draw attention to this small village while creating community empowerment. they rely on an original reinterpretation of the local intangible cultural heritage, such as rituals, traditions and narratives. in addition, the program is dense and varied with musical concerts, conferences, film screenings, and artistic performances. it is organized in the oldest part of the village, reusing semi-abandoned public spaces. part of the programme takes place in five other municipalities in alta irpinia. the audience is about 1000 people per day, with peaks that in 2020 reached about 40,000 presences at the final concert (growing from 2013). this is an international audience, even if 70% of the participants come from the campania region (data provided by the organizers, who each year elaborate a self-assessment). the economic support is provided by local institutions (municipalities and local action groups), but also in a large part by the campania region through european funds. the second case is the translations workshop (fig. 5) , which takes place in the municipality of aquilonia. it is an experimentation of a larger project called "e.colonia", which aims to create a training and artisanal district, where designers and makers can work together innovating the local artisan knowledge. the organizing group is composed of local architects and academics, who manage the event together with the local action group (lag), offering financial support. they form groups composed of about 50 people, including local craftsmen, designers, artists and students, who produce prototypes of "rural design" objects in two weeks, inspired by local traditions and skills. the project required the workshop to be annual, so as to create a new artisan network, which could better connect designers to regional traditions, while also opening up new markets for local artisans (fabbricatti 2017) . however, the lack of political support prevented this from happening. the format, which was probably highly ambitious, clashed with the visions of the municipal administration and with a moment of political redesign of the local action groups in alta irpinia. as a result, an exhibition of the prototypes and conceptual ideas was organized at the end of the event. in addition, several professionals who had met during the event, held in 2015, have continued to collaborate. the third case is the cairano 7x festival (fig. 6) . this is also an annual event, organized every summer since 2009. it takes place in the municipality of cairano, which is one of the smallest in the territory with only 300 inhabitants. the organizers are both the village association (pro loco) and a group of creatives and artists living elsewhere in the province, who create their own association (called "temporary communities" and then "irpinia 7x"). the objective is to publicize the case of a small village trying to survive by repopulating it for 1 week each year. they also want to reveal the qualities of rural villages, such as air quality, tranquillity and creative inspiration. during this one week, participants can take part in construction workshops, short film and gardening competitions, theatrical performances and activities for children. they can also sleep in the vacant houses of the village. temporary repopulation brings some years around 500 visitors to the village (boissenin 2019, p. 116) . the series of cultural events fulfil meet the project of the municipality to restore and enhance its built heritage. the economic support was first sourced by local associations and the municipality with the help of a private sponsor, then sustained by european funds. the event management system here is more informal, most of the decisions are taken during the general meetings of the association "irpinia 7x", which are moments of conviviality open to both the community and stakeholders. the questionnaire intercepted about 500 people and received 211 responses: 103 for sponz fest, which involves a larger audience; 68 for translations and 40 for cairano 7x. the "mortality rate" of the questionnaire (about 40%) can be justified primarily by the type of tools that were adopted for its dissemination (email and paper distribution at aggregation points). moreover, the questionnaire required a commitment in terms of time and concentration, due to the number of questions and their content. the main positive outcome of the festival regards the "people-place connection" (fig. 7) . the respondents were particularly unanimous about the ability of the event to reuse places and buildings (81% replied yes) and about its contribution to initiate a broader vision of cultural heritage (84% replied yes), including the oral traditions. the opinions about the "community infrastructure" attribute are more divided. we still obtained 45% of "yes" for the improvement of cultural services and 34% for the touristic ones. the interviews made it possible to understand that the indecision was due to the fact that the positive results linked to the event are temporary and the residents are deprived of these services for the rest of the year. a slight majority of "no" votes prevailed for the indicator about transport services. however, the interviews shed a larger perspective: sponz fest was a strong supporter of the local association which has managed to reopen the avellino-rocchetta railway line (suspended a few years before due to the lack of users and maintenance). every year during the festival, a train service was implemented to take participants from other villages to boissenin (2017) the event, and that contributed to highlighting how the railway line has a touristic potential. better results were achieved for the "knowledge, skills and learning" attribute, with a large majority of "yes" (79%) being given by the actors involved in the event organisation. the festival provides significant experience for the volunteers in team management, public reception, communication, both in terms of skills acquired and curricular experience. the sponz fest seems to help build a "diverse and innovative economy" increasing the cultural sector. half of the respondents believe that the event has reinforced the tendency to develop heritage-led projects, although they question the capacity of these projects to generate new and innovative job opportunities. finally, we noticed the strengthening of "community networks" and the building of an "engaged governance". a diversity of stakeholders were involved, with the participation of six municipalities to the event-which is rare in alta irpinia. the organisers, institutions and partners agreed that all the relevant actors were present and played their part in setting up sponz fest, with respectively 50, 71 and 67% of the votes. according to the answers of the questionnaire, the main positive outcome of the translations workshop was the enhancement of "knowledge, skills and learning" of the involved actors: 100% of the institutions, organisers and participants, and residents said "yes" (fig. 8) . the on the contrary, the event seemed particularly powerless in relation to the improving of "community infrastructure" with a majority of "no" for 4 of the 5 indicators. the workshop is part of a larger project to reuse the ancient abandoned area of the village of aquilonia as a design academy. the project for political and financial reasons has yet to be realized. it would have represented an important cultural infrastructure. this result leads to the issue of "engaged governance". the stakeholders seemed unanimous about the collaborative approach of the event (from 50% for tourists to 100% for the institutions and residents) and generally agreed on its capacity to involve all the relevant actors (from 40% for the partners to 87% for the organizers), but the interviews revealed a more mixed view: the involved actors were mainly from the private sector and we could also notice the reluctance of the municipality of aquilonia, which led the project promoters to seek the support of other institutions, such as local action groups. the results of the survey about the cairano 7x festival (fig. 9) were elaborated considering all the interviewees as a single category of actors, due to the small number of answers obtained from the questionnaire (40). like sponz festival, the interviewed actors particularly agreed on the ability of the cairano 7x to reuse the abandoned houses. we have to precise that the cultural practice met with the plan of the municipality to restore its built heritage, a theatre school and new services were created in some abandoned buildings. this nevertheless, the respondents found it difficult to assess the ability of cairano 7x to generate a "diverse and innovative economy" (80% replied "maybe"). the interviews helped to note that the opening of the theatre academy brings new career opportunities for the young people from the area; they have access to an education program that did not exist before. when it comes to the existence of an "engaged governance", 60% of the respondents agreed on the collaborative approach of the event. however, we need to report some conflicts between the external actors (irpinia 7x association) and inhabitants, along with their own cultural committee (pro loco). only after a few editions, the inhabitants realized the particular value of their village, but they did not agree with the way it was valued, with the activities responding more to the expectations of tourists than to their own. so, they decided to separate from the first association and create their own events. this conflict allowed the locals to move from a passive behaviour to an active construction of a cultural offer that corresponded to their interests and expectations. the cultural and creative practices examined have in common the strengthening of "people-place connection" (fig. 10) . moreover, the respondents particularly agreed on the attribute of "knowledge, skills and learning" for the ability of the practices to develop educational actions and to enable dissemination of culture (96% on average over the three events). on the contrary, no real impact was noted on "community infrastructures", with a majority of "no" answers, in particular regarding the mobility infrastructure (68%) and social or health services (54%). only the cultural infrastructures seemed to be improved in two of the three cases, but most were activated occasionally. then, respondents were not able to express themselves on the capacity of the events to generate "diverse and innovative economy": a majority of "maybe" prevails, caused above all by the seasonality of the events. a similar situation arises for the indicators related to "community networks". the responses still converge on the capacity to strengthen existing networks (94%). with the help of the interviews, we know that the three practices did not generate new associations but better articulated the existing ones. finally, the apparent consensus on the existence of an "engaged governance" needs to be revisited. for cairano 7x, a "maybe" majority wins for 2 of the 3 indicators, while all three indicators are green for sponz fest and translations: "development of a collaborative approach to event management" even reaches 72% of "yes" on average over the three practices. the interviews revealed a more mixed picture. while some of the institutions seemed willing to cooperate, others were still very reluctant to engage with the community-a situation shared by the different case studies. the cross-reference of the results highlights some useful topics for discussion. first, the indicators developed proved effective for the survey and provided a complex view of not only community resilience, but also the contribution that the heritage community concept can make in its pursuit. concerning the effects of the practices examined on building heritage community resilience, the results of the survey demonstrate that a hc is actually emerging in irpinia, but that the road to building a more resilient community is still long. the practices initiated the community towards a process of acquisition and/or consolidation of knowledge, competence and awareness of its biophysical environment and the care it requires. moreover, thanks to their involvement in heritage-led practices, the inhabitants discovered that cultural heritage can be a source to build new and creative job opportunities. the examined practices suggested new approaches (innovation of craft knowledge, creation of educational centres, etc.) that diversify the solutions traditionally foreseen for the relaunch of these territories (such as tourism, industrial settlement, etc.), and encourage new economies (sponzfest), start-ups (translation) and cooperative businesses (cairano 7x). in addition, through the involvement of different actors and community networks, the practices gave the opportunity to address actions towards building community infrastructures (the reopening of the avellino-rocchetta railway line for tourism purposes, the rediscovery of old transhumance routes and green infrastructures, enhancement of cultural and tourist services, of digital technologies, etc.). with regard to engaged governance, a good cooperation between different types of actors was noted, as well as the participation of a wide and differentiated range of actors. moreover, some institutions showed a good ability to cooperate in the general interest (sponz fest together with six municipalities). however, the poor propensity of some local administrations to engage in a more democratic approach and in vertical collaboration persisted (translations workshop), as did the existence of conflictual situations between residents and non-residents, due to different interests (cairano 7x) or to the reluctance of some inhabitants to an innovative approach. it is also necessary to underline data from the interviews that the indicators did not reveal. the administration of the municipality of calitri highlighted that following the sponzfest sales of properties for holiday homes of italian and foreign visitors were recorded in the historic centre. in addition, to support the survey, quantitative data were collected for some sample indicators. analyzing the requests for building maintenance and rehabilitation in the municipalities examined, the data show a slight increase since 2015. although in these municipalities of a few inhabitants, the numbers of requests are low, the data show a constant trend, particularly positive in the municipality of calitri, which from 2015 shows an almost exponential growth. this data can be referred both to the indicator "development of actions for the care of cultural heritage" of the "people-place connection" attribute, as well as to the "development of interest in heritage-led actions" related to the "diverse and innovative economy" attribute. the latter was also verified by collecting data on the number of the employed population (between 15 and 64 years of age). they are not easy to interpret because of the multiple economic categories they include. starting from 2011, in fact, calitri records a negative trend (51.13% in 2011; 49.86% in 2019), while a positive trend is recorded in the municipalities of aquilonia (50.16% in 2011; 51.20% in 2019) and cairano (44.54% in 2011; 53 .07% in 2019) (istat 2011; infodata 2019). direct surveys show, however, for calitri as well as aquilonia the creation of some new and innovative jobs, which also reveal synergies between inhabitants of different municipalities. a further survey, through archival data, concerned the number of accommodation facilities, the relative number of stay, and the presence in tourist offices (pro-loco) outside the week or period of the events, which can be referred to the attribute of "community infrastructure". also in this case, since 2013 there is a positive trend for calitri. aquilonia and cairano shows a constant trend during the year, that in august sees the population double for the return of natives living abroad, and peak in the days of the festival. finally, data on the trend of the real estate market since 2013 show an irregular performance with maximum house sales values that remain constant in the municipalities of calitri and aquilonia (https ://www.agenz iaent rate.gov.it). it is useful to underline that this last data excludes, or reduces, the risk of trade-offs, such as the cases of gentrification, that some authors detect by analysing the dynamics of cultural and creative processes (duxbury and campbell 2009; kebir and crevoisier 2008; mitchell and de waal 2009 ) other types of trade-offs are pointed out by some authors such as: the risk that the commodification of certain components within the culture could turn a community into 'a folkloric spectacle' , contributing to the destruction of the very image of rural heritage and to the reproduction of a 'leisure-scape' (mitchell and de waal 2009) ; the possibility that certain temporary events can create a gap in the economic and political situation by interrupting the regularity of a virtuous circuit established between the social, economic and political components during the year. to avoid these risks, it is recommended to monitor data over a longer period of time and, as pointed out by evans (2005) , to evaluate the sustainability and distributive equity of cultural and creative practices "seeking better engagement/consultation with local communities to improve ownership of the (cultural) project and (local) benefits" (dcms 2003, p. 2) . starting from these findings, it is possible to identify some elements that could positively influence heritage community and community resilience, in a self-sustaining circuit. a plurality of actors and competences has proved to be a fertile element for all practices. the involvement of the local community, internal and external organizers, of external people who had never before visited those places, of both local and external heritage experts was observed in each practice. in this process, the encountering of these different actors helped the unveiling, decoding and enhancing of values to be attributed to cultural heritage, triggering a virtuous circuit of awareness and care. building a shared project between the inhabitants and their elected representatives is strategic to achieving cr. cultural heritage plays its role as a "federation" in each of the three case studies. several actors put aside their reticence and personal interests to contribute to a project of collective interest. by learning to work together, many actors begun to rebuild relationships, which are essential for cr. heritage thus has become a dimension that 'unites' and allows for the fertile confrontation among multiple identities. it also allows to highlight the skills and talents of the community, mediating among different points of view and interests, in a perspective of common interest (fusco girard et al. 2017) . building a proactive and responsible role of the inhabitants supports community resilience. from the interviews, we learned that after the event people usually try to continue working on other cultural and creative practices or initiatives. since the early 2000s and the spread of a cultural movement in irpinia (boissenin 2019, p. 113 ), a succession of cultural practices have led to a growing proportion of local people and new inhabitants becoming active. the community raised its voice, gradually forcing the institutions to take its demands into account. the relationship that exists between the community and place becomes, in turn, a prerequisite for its care and conservation, with direct effects on the reduction of the physical and social vulnerability of the territory. recognition of a complementarity between community and institutions is useful for the success of heritage-led practices, and for the objective of heritage community resilience. the positive results achieved in the objectives of heritage community and community resilience were made possible due to one category of actors taking a step towards the other. the events happened because the creative and management skills of the community met the ability of the institutions to have access to sources of funding and networking. in the case of the translations workshop, precisely the lack of support from the administration was one of the main reasons for its short duration. this paper explored the issue of community resilience with the objective of helping to reduce emerging gaps between theory and practice (stumpp 2013) and at the same time enrich the debate on the contribution of cultural heritage to cr. the paper elaborates a conceptual framework from which to define the perspective of heritage community resilience. this original concept, described in the paper through 23 indicators, can act both as a new target and a process in which cultural heritage supports the building of a community able to prevent, cope with and recover from disturbances. in an evolutionary vision of resilience, culture and cultural heritage can be the key to citizen engagement (idea of common good), as well as to social, environmental, economic and governance innovation. through a survey of several heritage-driven case studies, either bottom-up or mixed bottom-up and top-down, based on direct analysis tools, the research tests the heritage community resilience indicators and highlights the characteristics and potential of the concept. the research context is that of italian inner peripheral areas, proved to be an interesting laboratory for the crucial challenges facing these territories. the practices analysed demonstrate that although a heritage community is actually emerging in alta irpinia, and despite the relevance of the issue in these areas, there is a lack of strategies and operational tools aimed at community resilience. from the lessons learned from the case studies, the concept of heritage community resilience imposes shared policies among institutions, residents, sector experts, entrepreneurship, researchers, facilitators, and humanitarian organizations, requiring to equip themselves with participatory management tools and defining a shared framework of governance of cultural policies. in this regard, the further perspectives of this study are to understand the relationship between hcr and community based disaster risk management (cbdrm). it is a process in which at-risk communities are actively engaged in the identification, analysis, treatment, monitoring and evaluation of disaster risks, contributing to the reduction of their vulnerabilities and the improvement of their capacities (adpc 2006; abarquez and zubair 2004) . in this direction, a contribution could emerge from the definition of heritage community (council of europe 2005 art. 2b). it implies collaborative actions of care and 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disaster risk reduction the hangzhou declaration placing culture at the heart of sustainable development policies transforming our world: the 2030 agenda for sustainable development exploring community resilience in times of rapid change community resilience: path dependency, lock-in effects and transitional ruptures publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations diarc, univ. of naples; idex univ. grenoble alpes/labex ae&cc. 1 department of architecture diarc , university of naples "federico ii", via tarsia 31, 80135 naples, italy. 2 labex architecture, environment and building cultures, grenoble school of architecture, univ. grenoble alpes, 60 avenue de constantine, 38036 grenoble, france. 3 act antropologia cultura territorio, via festo avieno 230, 00136 rome, italy.received: 30 june 2020 accepted: 29 october 2020 each author has made substantial contributions to the conception and design of the work; or the acquisition, analysis, or interpretation of data; or the drafting of the work or its revision; and has approved the submitted version; and agrees to be personally accountable for the author's own contributions and for ensuring that questions related to the accuracy or integrity of any part of the work, even ones in which the author was not personally involved, are appropriately investigated, resolved and documented in the literature. kf: literature review, conceptualization, methodology, discussion, conclusions; lb: data curation, findings, writing-original draft preparation; mc: literature review, investigation, writing-reviewing and editing. all authors read and approved the final manuscript. not applicable. the datasets used during the current study are available from the corresponding author on reasonable request. the authors declare that they have no competing interests. key: cord-318336-hslnkv6p authors: ke, kai-yuan; lin, yong-jun; tan, yih-chi; pan, tsung-yi; tai, li-li; lee, ching-an title: enhancing local disaster management network through developing resilient community in new taipei city, taiwan date: 2020-07-24 journal: int j environ res public health doi: 10.3390/ijerph17155357 sha: doc_id: 318336 cord_uid: hslnkv6p large-scaled disaster events had increasingly occurred worldwide due to global and environmental change. evidently, disaster response cannot rely merely on the public force. in the golden hour of crisis, not only the individuals should learn to react, protect themselves, and try to help each other, but also the local school, enterprise, non-government organization (ngo), nonprofit organization (npo), and volunteer groups should collaborate to effectively deal with disaster events. new taipei city (ntpc), taiwan, was aware of the need for non-public force response and therefore developed the process of enhancing local disaster management networks through promoting the resilient community since 2009. the concept of a resilient community is to build community-based capacity for mitigation, preparedness, response, and recovery in an all-hazards manner. this study organized the ntpc experience and presented the standard operation procedure (sop) to promote the resilient community, key obstacles, maintenance mechanism, and the successful formulation of the local disaster management network. the performance of the promotion was evaluated through a questionnaire survey and found that participants affirmed the positive effect of building community capacity through the entire process. in general, the resilient community as the center of the local disaster management work is shown promising to holistically bridge the inner/outer resources and systematically respond to disaster events. global warming and environmental changes have led to more frequent and extreme weather events and resulted in disasters of a greater magnitude worldwide. serious disaster events accompanied by significant casualties repeatedly occurred, such as the 1995 great hanshin earthquake in japan, the 1999 chi-chi earthquake in taiwan, the 2004 indian ocean earthquake and tsunami, 2005 hurricane katrina in the usa, 2008 sichuan earthquake in china, 2009 typhoon morakot in taiwan, as well as 2011 tohoku earthquake and tsunami in japan. exposure of persons and assets in all countries has increased faster than vulnerability has decreased, thus generating new risks and a steady rise in disaster-related losses, especially at the local and community level. the impact could be short, medium, and long term and appears in terms of economic, social, health, cultural, and environmental aspects [1] . in the 1995 great hanshin earthquake, during the early stage, 34.9% of those in danger survived by themselves, 31.9% escaped with assistance by family members, 28.1% by neighbors/friends, and 2.6% by passerby [2] . only less than 1.7% of those in need of help were saved by the public in the 1995 great hanshin earthquake, during the early stage, 34.9% of those in danger survived by themselves, 31.9% escaped with assistance by family members, 28.1% by neighbors/friends, and 2.6% by passerby [2] . only less than 1.7% of those in need of help were saved by the public force. this investigation indicated that, in such a great-scaled disaster, public force usually could not timely reach all the affected areas. therefore, the community must be resilient enough to respond by themselves and help each other in the golden hour of crisis events. community resilience refers to the capacities and capabilities of a human community to "prevent, withstand, or mitigate" any traumatic event [3] . to strengthen community resilience, not only the residents but also neighboring stakeholders, no matter the public sector or private sector, units, or individuals, should join together to form a local disaster management network. it is not easy for the community to organize such a network by itself; hence, the government must invest funding and resources to accomplish this goal. many studies have shown that to deal with disasters, whether pre-disaster [4, 5] , in-disaster [6] , or post-disaster [7] , awareness raising [8] and capacity building [9] are of significant importance, especially at the community level. this study aims to present how new taipei city (ntpc) government, taiwan, integrated the resources at the local government level and enhance the local disaster management by building a significant amount of resilient community, and begins with why the promotion of resilient community is necessary and how the promotion links to the local disaster management network. the performance is assessed through a questionnaire survey. two successful cases of community operation are introduced. from the ntpc government's angle, its experience from nowhere to somewhere is investigated and key obstacles, as well as solutions, are finally identified. new taipei city, taiwan, covers an area of 2053 km 2 with a population of 4 million. there are 29 districts and 1032 villages under ntpc authority. districts can be categorized into 3 types, i.e., 8 in the urban areas, 15 in the rural areas, and 6 in urban-rural areas. geologically, ntpc is extremely vulnerable to earthquakes due to the direct pass-through of active shanchiao fault from the southwest to the north-east. from a topographical perspective, 88% of ntpc is the mountainous area (partly covered by tatun volcano), and the entire coastline is 126 km long, which means ntpc is prone to geohazards such as debris flows, landslides, volcano eruptions, and tsunamis. flooding is another disaster event happening frequently due to annual typhoon and torrential rain. furthermore, two nuclear power plants are situated in ntpc, implying possible nuclear hazards ( figure 1 ). according to the report by the national fire agency, ministry of interior, taiwan [10] , a total of 42,308 (partly) collapsed buildings, 20,843 casualties, and 87,949 citizens in need of shelter are likely to happen if a large earthquake of scale 6.6 occurred in the center of taipei basin. with such kind of catastrophic damage, the public force is unlikely to give support for all affected areas fully and timely. more assistance from private sectors or citizens is necessary, especially those in or nearby the disaster hotspots. ntpc's disaster management system can be divided into three levels, i.e., local government, district office, and community, from the top down. ntpc government was aware of the complex and hazard-prone environment, as well as the abovementioned potential damage which cannot rely on merely the government's capacity. therefore, the government thought of enhancing the local disaster management network through matching cooperation between the local units and individuals. to do so, the promotion of the resilient community was considered as the cornerstone. seven standardized steps were taken to develop a resilient community in ntpc as follows [11] . stakeholders in the resilient community include the public sector, community residents, and at least one expert in the disaster management field. to coordinate the resilient community promotion, the start-up meeting is hosted. in the meeting, it is vital to make sure the key person in the community, usually the village chief or community committee chairman, understands the benefit of the resilient community and has the willingness to cooperate in the future activities to be hosted. to encourage community participation, it is necessary to arouse public interest through the activation workshop in which the invited expert would give the lecture on the resilient community. because not all the community had experienced a serious disaster event, the lecture material usually includes not only the concept of the resilient community but also some case studies about disaster scenarios and associated casualties in taiwan or worldwide. successful cases of resilient community operation were also delivered to construct the vision and inspire the residents' participation in future activities. all lecture materials are prepared for the layperson rather than for an expert in order to ensure the lecturer and participants are on the same page. there has to be a broader and more people-centered preventive approach to disaster risk. disaster risk reduction practices need to be multi-hazard and multi-sectoral, inclusive, and accessible to be efficient and effective [1] . therefore, community residents are invited to jointly investigate the environment. accompanied by experts, residents learn to identify potential/historical disaster hotspots and resources, such as shelter, convenience stores, and public facilities, useful for responding to the disaster event. after the site survey, all participants will furtherly discuss associated strategies through following 4 minor steps ( figure 2 ): sorting photo: during the site survey, photos are taken and printed. participants are asked to sort out the photos into two categories, i.e., disasters hotspot and resource points. mapping photo: those photos sorted in the previous step are pasted on the aero map with stickers near the photo. if the photo is a disaster hotspot, its condition, such as the location and cause/effect of the potential disaster is written down on the stickers; if the photo is a resource point, its function is described. strategy discussion: with possible disaster conditions and resource points at hand, the expert will help participants discuss strategies to deal with issues from the perspective of the individual, the community, and the local government level. for example, trash sometimes jams the gutter and causes flooding; therefore at the individual level, every resident should be made aware of not dropping trashes in the gutter; at the community level, residents should team up to clean the gutter regularly especially before the flooding season; at the local government level, district office can ask the cleaning contractors to dredge the cutter or provide the community with equipment needed to clean it. local enterprises and schools can be invited to discuss their role as outer resources to help the community respond to disasters. 4. experience sharing: the goal of this workshop is to finalize valid strategies mainly by the community; therefore, resident representatives are asked to report the discussed strategies to all the participants and try to reach consensus. aware of not dropping trashes in the gutter; at the community level, residents should team up to clean the gutter regularly especially before the flooding season; at the local government level, district office can ask the cleaning contractors to dredge the cutter or provide the community with equipment needed to clean it. local enterprises and schools can be invited to discuss their role as outer resources to help the community respond to disasters. 4. experience sharing: the goal of this workshop is to finalize valid strategies mainly by the community; therefore, resident representatives are asked to report the discussed strategies to all the participants and try to reach consensus. to efficiently carry out strategies in the previous step, the resilient community response team is organized. the typical structure of the response team is shown in figure 3 . it contains five divisions, namely, patrol, evacuation, rescue, medical, and logistics, with their general function as table 1 . the commander, usually the village chief or community committee chairman, supervises the deputy commander and executive secretary, as well as oversees outsourcing and leads the team. the deputy commander supervises the heads of every division and the executive secretary assists the commander and the deputy commander. to efficiently carry out strategies in the previous step, the resilient community response team is organized. the typical structure of the response team is shown in figure 3 . it contains five divisions, namely, patrol, evacuation, rescue, medical, and logistics, with their general function as table 1 . the commander, usually the village chief or community committee chairman, supervises the deputy commander and executive secretary, as well as oversees outsourcing and leads the team. the deputy commander supervises the heads of every division and the executive secretary assists the commander and the deputy commander. aware of not dropping trashes in the gutter; at the community level, residents should team up to clean the gutter regularly especially before the flooding season; at the local government level, district office can ask the cleaning contractors to dredge the cutter or provide the community with equipment needed to clean it. local enterprises and schools can be invited to discuss their role as outer resources to help the community respond to disasters. 4. experience sharing: the goal of this workshop is to finalize valid strategies mainly by the community; therefore, resident representatives are asked to report the discussed strategies to all the participants and try to reach consensus. to efficiently carry out strategies in the previous step, the resilient community response team is organized. the typical structure of the response team is shown in figure 3 . it contains five divisions, namely, patrol, evacuation, rescue, medical, and logistics, with their general function as table 1 . the commander, usually the village chief or community committee chairman, supervises the deputy commander and executive secretary, as well as oversees outsourcing and leads the team. the deputy commander supervises the heads of every division and the executive secretary assists the commander and the deputy commander. pre-disaster in-disaster and post-disaster patrol 1. understanding and periodically patrolling the disaster potential area and hotspot. eliminating disaster factors in advance, such as cleaning gutters. monitoring weather and patrolling disaster potential area. if a disaster condition is spotted, send messages to the community command center and make records. setting up a cordon around a disaster point and prevent from a passerby in. tabulating and periodically updating the vulnerable residents, such as elderly, incapable people and those living in disaster potential areas. planning evacuation route. making and periodically updating the evacuation map. reminding and assisting the residents, especially the vulnerable residents, to evacuate in an emergency. making sure the evacuation route is safe and not blocked. helping traffic control in vital traffic intersection and direct the evacuating people. maintaining existing equipment and assess the need for additional equipment based on disaster type and potential in the community. being familiar with the equipment operation through periodically training. keeping smooth telecommunication by preparing walkie-talkie. preparing the equipment and applying it in a small-scaled disaster event, such as putting out a small fire with a fire extinguisher or sawing a fallen tree into pieces and removing it to avoid traffic congestion. if residents were trapped due to serious events, trying to identify their location and asking support from the authority concerned. being proficient in first aid and caring skills 2. periodically training residents with those medical skills. preparing items for medical purposes, such as first-aid kit and stretcher. helping injuries in need of first aid. guide outside medical resources to people in need. helping local governments open shelters and prepare living supplies. mentally comforting the refugees scared by disasters. assessing the living material, such as drinking water, food, and medical needs, required during a disaster event. tabulating and periodically updating the community response team members. helping the local government maintain shelters. helping local governments open shelters and prepare living supplies. helping refugees register when they arrive at the shelters and distributing living supplies. supporting the other four response team divisions. based on the characteristics of the potential disaster, the community action plan is suggested to include but not limited to the following items. environmental and disaster risk assessment the environmental assessment should cover the location of the community, its neighboring geography, social condition, and historical disaster hotspots. the disaster risk assessment must include disaster type the community is facing and associated risk map drawing. the community usually has no capacity of drawing such kind of risk map; therefore, it is advised to utilize some government resources. in taiwan, the national science and technology center for disaster reduction (ncdr) developed the risk map platform (https://dmap.ncdr.nat.gov.tw/) for the public to have access to risk maps of earthquake, landslide, debris flow, flooding, tsunami, and nuclear event nationwide. community response team and local disaster management network the community response team is the frontline force to deal with the disaster. according to the experience of all resilient communities promoted by the ntpc government, the general functions of the team were organized as in table 1 . in addition to the community's strength, outer resources, such as district office, fire department, police department, school, enterprise, volunteers, ngo, and npo could be invited to formulate a local disaster management network and cooperate pre-disaster, in-disaster, and post-disaster. community resources mean the equipment such as pump, power generator, fire extinguisher, and power saw owned by the community or facility such as activity center, shelter, and community office managed by the community. however, those existent resources might not fully meet the need in terms of disaster response. the community should periodically update resources inventory and proactively assess the extra demand for resources to deal with the possible disaster. all the resources must have someone be appointed to manage. some of the duties could be assigned to the community response team member as a suggested division task in table 1 . after the resilient community is established, the top issue is that the community sometimes does not keep on its work due to not having a sustainable operation mechanism to follow. the standard sustainable operation mechanism for the resilient community in ntpc includes the following items: (1) regular training: it defines the courses and skill training to behold and its frequency; (2) community disaster management database update: it includes the response team member recruitment/retirement, vulnerable residents list update, and equipment maintenance frequency; (3) disaster processing record: the community should record the action taken pre-disaster, in-disaster, and post-disaster. it helps review the community action as well as identify defects and weak points of the plan. the community action plan was discussed and instituted by the residents and the community response team. stakeholders, such as the school, enterprise, or vulnerable individual/groups in the neighboring area, were welcome to join the discussion. the role of each stakeholder was be identified, e.g., community response team as helpers; residents and vulnerable individuals/groups as help receivers; enterprise as helpers and living material supplier; school as shelter accommodators. education and training aim to develop the knowledge and basic skills for community residents responding to disasters and specifically enhance the response team's capacity to execute their tasks. for the basic knowledge, the courses include disaster response concepts according to the community disaster characteristics. the required skills include basic first aid, such as cpr (cardiopulmonary resuscitation), heimlich maneuver, and aed (automated external defibrillator) and operation of equipment such as fire extinguishers, pumps, power saws, etc. this course is suggested to be hosted at least once per year. the community response team members could practice their tasks and skills through the war game or drill. war game helps test the validity of the action plan established in step 4, and the drill can further test the skills learned from step 5. in ntpc, not only the community response team but also stakeholders in the neighboring area, such as staff from the district office, the local fire department, school staffs, and enterprise partners are role players. table 2 is the typical scenario designed for an earthquake drill in ntpc. a few key principles are suggested as follows: 1. scenarios must correspond to community characteristics in terms of single disaster or complex disaster. 2. self-protection skills of individuals could be exercised, such as "drop", "cover", "hold on" during the earthquake. the disaster scale should be designed properly so that the community must and could react. if the scale is too small, then no significant damage will highlight the necessity for community response; if the scale is too large, most community members might lose their capability due to casualties resulting in malfunction of the team. every division in the community response team should have the chance to familiarize themselves with their tasks and required skills. coordination and communication among the response team, stakeholders, and public/private agencies should be tested. 6. the community should understand the evacuation routes to the shelter as well as arrange and test the transportation for evacuation. 7. collaboration between the district office and the community team to open the shelter should be exercised. scenario 1 self-protection, such as "drop", "cover", "hold on" exercise at the time of an earthquake. community response team mobilization and preparedness. preparedness for opening shelter by logistic division. the assistance of refugee evacuation to the shelter by evacuation division. patrol division surveys the area and calls for help from the rescue division upon locating damage. assistance by logistics division in shelter opening, such as registration, food sharing, and related operations. living supply may come from the enterprise. first-aiding the physically wounded people or caring for the traumatized people by medical division. rescue division puts out small-scaled fire induced by the earthquake scenario 9 recovering the environment by the entire response team and community residents. upon completion of resilient community development, posters and videos are made showing the annual activities and joint efforts achieved by the community, government, school, and enterprise. the community response team member share experiences with those from other communities/villages who have never joined the resilient community workshop. the purpose is to not only encourage the ongoing involvement in this developed resilient community but also inspire other villages' participation shortly. to evaluate the effect and performance of promoting a resilient community, an anonymous physical questionnaire survey was conducted after we finished each resilient community for that year. the participants were informed that participation was voluntary and the participants' willingness to return the completed questionnaire indicated their consent to participate in this study. eight key questions were asked as follows: q1: do you understand the disaster risk of your community after the workshop? q2: do you feel developing a resilient community and building capacity is necessary? q3: has your community built a feasible action plan after the workshop? q4: do you understand the tasks of the response team? q5: are you willing to become a member of the response team? q6: have you learned basic medical skills and been capable of performing it when necessary? q7: have you learned the fire-fighting skills and been capable of performing it when necessary? q8: is retraining necessary for the community? q1 and q2 checked if the participants were aware of the disaster risk and management; q3 checked if the community action plan was built and valid; q4 and q5 checked if the participants understood the tasks they should perform while they became response team members; q6 and q7 checked if basic skills were well taught; q8 checked the necessity of hosting retraining courses, and is linked to the maintenance mechanism in section 4.2. despite the eight key questions, only age and gender information were collected; therefore, no personal information of any specific individual could be exposed. table 3 shows the age distribution of respondents who joined the workshops hosted by the ntpc government in 2019. we kindly asked every participant to do the questionnaire for us right after the workshop; therefore, the response rate was 100%. from a total of 1180 participants, including 520 males and 660 females from 33 communities, more than 80% of them were over 50 years old, and more than 50% were over 60 years old. the aging population phenomenon is very common in rural areas of ntpc which are usually prone to high disaster risks. it implies that their mobility to react to disaster events is relatively low before the promotion of a resilient community. the questionnaire was designed to confirm the contribution of promotion, and results are shown in figure 4 . the survey has shown that, after 7-steps of promotion as described in section 2.2, 93% of the participants realize the risks they are facing and 91% agree with the necessity to develop a resilient community; 91% believe that the action plan we helped them build is feasible; 89% understand the tasks of the response team and 87% are willing to serve the community as a team member; 98% and 94% think that they had well learned and were ready to perform basic medical skills and fire-fighting, respectively; 95% also thinks retraining is important for the community. overall, about 90% of the participants' awareness was raised and the capacity to deal with community-based disaster events the survey has shown that, after 7-steps of promotion as described in section 2.2, 93% of the participants realize the risks they are facing and 91% agree with the necessity to develop a resilient community; 91% believe that the action plan we helped them build is feasible; 89% understand the tasks of the response team and 87% are willing to serve the community as a team member; 98% and 94% think that they had well learned and were ready to perform basic medical skills and fire-fighting, respectively; 95% also thinks retraining is important for the community. overall, about 90% of the participants' awareness was raised and the capacity to deal with community-based disaster events was established. it indicates the triumph of resilient community promotion and implies its contribution to the successful community operation introduced in the next section. two case studies are introduced to demonstrate how the established resilient community reacts pre-disaster, in-disaster, and post-disaster. those cases may not have been catastrophic events but showed how the community spontaneously mobilized after the training received through building community resilience. jiaqing village, an urban village located in zhonghe district, is the resilient community that started in 2019. this village was prone to flooding, earthquake, and fire. after the village was trained and the community response team was organized, it progressively operates whenever there is a typhoon coming ( figure 5 ). the village chief, as the response team commander will host a preparedness meeting and assign tasks for the team. the biggest concern is to prevent the low-lying area from flooding; therefore, team members were sent to the gutter and drainage outlet where garbage is easily accumulated. once waste was found stuck in the drainage system, the team notified the district cleaning contractor and cleaned the site together. occasionally, if the cleaning of the drainage system could not prevent the flooding from happening, the team recorded the situation for the village chief to discuss improvement measures thereafter. respectively; 95% also thinks retraining is important for the community. overall, about 90% of the participants' awareness was raised and the capacity to deal with community-based disaster events was established. it indicates the triumph of resilient community promotion and implies its contribution to the successful community operation introduced in the next section. two case studies are introduced to demonstrate how the established resilient community reacts pre-disaster, in-disaster, and post-disaster. those cases may not have been catastrophic events but showed how the community spontaneously mobilized after the training received through building community resilience. jiaqing village, an urban village located in zhonghe district, is the resilient community that started in 2019. this village was prone to flooding, earthquake, and fire. after the village was trained and the community response team was organized, it progressively operates whenever there is a typhoon coming ( figure 5 ). the village chief, as the response team commander will host a preparedness meeting and assign tasks for the team. the biggest concern is to prevent the low-lying area from flooding; therefore, team members were sent to the gutter and drainage outlet where garbage is easily accumulated. once waste was found stuck in the drainage system, the team notified the district cleaning contractor and cleaned the site together. occasionally, if the cleaning of the drainage system could not prevent the flooding from happening, the team recorded the situation for the village chief to discuss improvement measures thereafter. baiyun village, a mountainous village located in xizhi district, is a resilient community stated in 2016. after six months of solid training and immediately after the community drill was performed on 8 october 2016, a landslide event occurred due to typhoon aere in the early morning of 9 october. the village chief, jun-di chen, immediately assembled the community response team as well as reported the situation to the xizhi district office and ntpc fire department as soon as he was notified by the residents who spotted the event. eight team members were called in and approached baiyun village, a mountainous village located in xizhi district, is a resilient community stated in 2016. after six months of solid training and immediately after the community drill was performed on 8 october 2016, a landslide event occurred due to typhoon aere in the early morning of 9 october. the village chief, jun-di chen, immediately assembled the community response team as well as reported the situation to the xizhi district office and ntpc fire department as soon as he was notified by the residents who spotted the event. eight team members were called in and approached the disaster site to evacuate people by knocking on doors one after another. once the government forces arrived and took over the frontline, the community response team helped set up the cordon to prevent residents from entering the disaster site. the team also helped the public force establish the command post in the nearby area to monitor disaster development and timely response. finally, when the situation was under control, the response team moved to the shelters and took care of the residents who had evacuated earlier. in total, 34 people took shelter in the baiyun activity center with no casualties reported. the resilient community developed in ntpc has by far been running for three phases as follows. most problems were identified in phase 1 and solutions were given accordingly in phases 2 and 3. ntpc has launched the resilient community since 2009. until 2015, only 13 resilient communities were developed by a few ntpc departments. the speed of promotion is quite slow because the nptc government was unfamiliar with the concept of the resilient community and need help from certain universities who have associated expertise and enough manpower to host the workshops and activities described in section 2.2. during the first phase, key factors impeding the promotion were identified as follows: in general, residents usually lack the willingness to participate in the resilient community workshop from the beginning due to three reasons. first of all, they think that if no serious disaster happened before then why would there be one in the future. next, there is already some structural protection in the community such as the dike or pumping stations/machines to prevent flooding and the retaining wall to prevent from hillslope disaster. they feel quite safe with those protection measures. finally, even if a disaster indeed happened, the government would come and help because the government must save the citizens. there are varying conditions in different communities. the community is usually prone to hillside disaster and debris flow in the rural area especially in the mountainous area; prone to earthquake and fire in the urban area especially with densely distributed old buildings; and prone to flooding in the low-lying area. therefore, there is no "one size fits all" approach for community resilience building [12] . although the goal of the resilient community is building capacity for it, the ntpc government specifically asks the public sector such as district office and local fire department corps and branch to progressively join associated activities. therefore, a great amount of time and involvement from the community and public sectors is required. it usually takes a minimum of 3-6 months to develop a base-type resilient community and up to 2 years to finish the complete-type resilient community. the minimum requirement for a base-type resilient community is to raise the residents' awareness and train their basic skills. for the complete-type resilient community, the 7 steps in section 2.2 should be strictly followed and their performance tracked to ensure a fully built capacity. it would cost 10,000 to 13,000 usd to hire the expert/team to finish one complete-type resilient community. there are 1032 villages in ntpc, and the total expense would exceed 10 million usd for all. the different authorities concerned are entitled to deal with different disaster types. for example, in ntpc, the water resources department and the agriculture department promote resilient communities prone to flooding and debris flow, respectively. it is not be a problem if the community has only a single disaster type. however, it is very common that the community has more than one disaster potential. more than one department can invest in the same community if they wanted to, resulting in the duplicate investment and waste of government resources, furthermore, harming the government's general interest. one other issue is that every department in the local government is a subordinate agency of certain authority in the central government which institute the policy to promote the resilient community. for example, the soil and water conservation bureau (swcb) under the council of agriculture supervises the agriculture department in ntpc. they focus only on debris flow and train the residents accordingly. on the other hand, the water resources agency supervises the water resources department in ntpc to build flood-proof capacity for the community. as a result, not all communities receive the same training and build the all-hazards response code. the abovementioned four obstacles account for the "integrated resilient community program" launched by the ntpc government in phase 2 and the necessity of establishing a maintenance mechanism, as shown in the following section. the different authorities concerned are entitled to deal with different disaster types. for example, in ntpc, the water resources department and the agriculture department promote resilient communities prone to flooding and debris flow, respectively. it is not be a problem if the community has only a single disaster type. however, it is very common that the community has more than one disaster potential. more than one department can invest in the same community if they wanted to, resulting in the duplicate investment and waste of government resources, furthermore, harming the government's general interest. one other issue is that every department in the local government is a subordinate agency of certain authority in the central government which institute the policy to promote the resilient community. for example, the soil and water conservation bureau (swcb) under the council of agriculture supervises the agriculture department in ntpc. they focus only on debris flow and train the residents accordingly. on the other hand, the water resources agency supervises the water resources department in ntpc to build flood-proof capacity for the community. as a result, not all communities receive the same training and build the all-hazards response code. the abovementioned four obstacles account for the "integrated resilient community program" launched by the ntpc government in phase 2 and the necessity of establishing a maintenance mechanism, as shown in the following section. (figure 6 ). it ensures not only the optimal utilization of the local government's resources but also the consistent procedures for all departments to follow and promote resilient communities. in phase 2, the school played quite an important role in the local disaster management network. the ministry of education had initiated the campus safety program in 2003, and the focus was on building school internal capacity until 2010. after 2011, schools were asked to gradually cooperate with nearby villages and communities in the context of disaster management. school and district activity centers are two major facilities in taiwan to shelter the refugees in a disaster event. the community and school must work together while opening the shelter. besides, both of them could in phase 2, the school played quite an important role in the local disaster management network. the ministry of education had initiated the campus safety program in 2003, and the focus was on building school internal capacity until 2010. after 2011, schools were asked to gradually cooperate with nearby villages and communities in the context of disaster management. school and district activity centers are two major facilities in taiwan to shelter the refugees in a disaster event. the community and school must work together while opening the shelter. besides, both of them could collaborate in medical service, mental caring, patrolling disaster hotspots, and dealing with small-scaled disaster events if needed. such cooperation is practically valid because most students, even teachers, are from a neighboring community and therefore a tight bonding already exists. the only movement needed to enhance the link and push forward is asking both parties to attend the resilient community workshop and discuss the terms of cooperation in the context of the local disaster management network. schools, especially at the university level, can also help build resilience capacity for the community [13] . in phases 1 and 2, all of the resilient communities were promoted by the local government's departments with help from certain universities. however, building community capacity to deal with disasters is the legal duty of the district office in taiwan. to help the district office learn and promote the resilient community by itself, the community consultant team was organized by the ntpc government in 2018. it hires experts specialized in community disaster management to train the district offices to promote the resilient community through the seven-step process. besides, the resources from enterprises were specifically introduced to the community in phase 3. as is well known, the key to successful enterprise disaster management is the development of business continuity planning (bcp). however, bcp functions more internally than externally. it means, with bcp, the enterprise knows how to deal with disaster by itself whether in terms of mitigation, preparedness, response, or recovery. what the ntpc government tries to achieve is to develop a cohesive local disaster management network that involves the collaboration of community, public sector, schools, and enterprises. the enterprise is the last piece to complete such a network. not all enterprises are suitable to join the network. the enterprise must meet three ntpc criteria such as positive image, enough scale, and high willingness. the ntpc government or district office will sign the mou with the enterprise after it is chosen. to build tighter bonding among stakeholders, the enterprise is invited to join the resilient community activity and discuss cooperation or action plan as mentioned in section 2.2.4. other than direct financial support to the community or public sector, there are various ways in which the enterprise can play a role in the local disaster management network. for example, the mitsui outlet park in linkou joined the drill hosted by the linkou district office and provided hot meals and medicines for nearby communities; yulon group, well known for its yulon motor co., ltd. offered xindian district office vehicles to evacuate community refugees. through helping the local government and community, the enterprise can not only fulfill corporate social responsibility (csr) but also enhance its image from the public sector's media propaganda. the maintenance of the resilient community is usually harder than its development; therefore, it is suggested to employed four measures as the ntpc government did and keep the heat on. retraining is vital as shown by the questionnaire survey (q8). various courses could be chosen from the following depending on the community's needs. tasks review of the community response team: new members will join the community response team now and then. it is of great importance to make sure each member, whether senior or newcomer, knows his/her task well. collection and reporting of disaster information: with the popularization of smartphones, more apps are available for collecting disaster information and uploading it to the cloud platform. the community should learn which technical tool is more suitable to the community and how it functions. all disaster information collected could be reserved in a community database for future review. advanced disaster response skills: basic skills such as cpr, heimlich maneuver, and fire extinguisher operation were taught while developing a resilient community. advanced skills, such as patient moving, escape from the fire scene, and responding with the tool at hand (e.g., making slippers with old newspapers; making simple toilets with paper box and plastic bag) are suggested in the retraining courses. considering the covid-19 pandemic in 2020, epidemic prevention is also suggested to be included in the retraining. thereby, every trainee could be a community watcher and help spread epidemic prevention knowledge and support the government's action if necessary. the selection of skills is not limited to specific disaster types that the community is most likely to confront. the advanced skill training aims to make the community function in an all-hazards response manner. 4. war game: every disaster management action plan should be periodically reviewed and tested. at the community level, war game is a less costing and less time-consuming way to validate the plan compared to drill. however, the design of a proper war game is still not easy for the community. they should deeply consider the potential risk and transform it into disaster scenarios for strategy discussion. they will also have to manage inner resources and seek additional outer resources. usually, inviting experts or public sector personnel to join the war game would help the community deliver more insightful outcomes. skills training and raising awareness are compulsory for community residents to increase their chance of survival in the catastrophic disaster event. with the right tools and equipment, the core function of self-help and mutual help could be even more effective. the ntpc government supports certain funding for the community to purchase equipment upon the completion of a resilient community establishment. the community could buy the equipment according to a predefined list which includes evacuation bag, disaster prevention hood, helmet, first-aid kit, stretcher, walkie talkie, pumps, fire extinguisher, trolley, power saw, power generator, emergency ration, etc. the purchased equipment should be listed in the community action plan and be maintained regularly. the response team member must be trained to operate it. issuing the resilient community certificate to those progressively engaged in associated activities and who made solid achievements would raise the community's sense of honor and make it more likely to keep on the operation. ntpc government initiated the certificate application program in 2018. the community receives the ntpc certificate (figure 7) , and it proves the following criteria have been met: environmental risk assessment: the identification of disaster potential and associated strategies must be delivered. community disaster management database: including the identification of vulnerable people in the community, inventory of equipment, list of community residents with special skills and who can help respond to disaster, and contact list of outer resources such as police department, fire department, volunteer, school and enterprise. 3. community response team: including the head and crew of the five-response team divisions. it is batter if the enterprise and school can join as a support division. skill training: including basic skills introduced in section 2.2.5. drill: including the script with properly designed disaster scenarios and the actual role-playing of 5 team divisions. ideally, after the resilient community is established, it should consistently and spontaneously operate by itself; nevertheless, this is usually not the case in reality. without the government's supervision or expert's assistance, some communities fail to keep on with the work. to avoid it, the ntpc government designed a simple performance tracking table (table 4 ) and asks the community to fill it in whenever a disaster happens or is expected to come. the table is separated into 5 operation types, valid not only for operation during the disaster event but also for mitigation measures on normal days. the following are some suggested actions that the community can take. 1. mitigation: including routine education, skill training, drill/war game, environment patrol, disaster information; 2. preparedness: including hosting preparedness meeting, equipment inventory, real-time weather monitoring and early warning, checking vulnerable people's condition and need, patrolling areas prone to disasters, and shelter opening preparedness; 3. report in: once the disaster is spotted, reporting to the community and the authority concerned for timely response, as well as to associated private sectors such as water company or power company for assistance; 4. response: including dealing with disasters such as removing fallen trees, fire-fighting, identifying risk area and setting up cordon; evacuating people in the high-risk area; helping public sectors such as opening shelter, traffic control, and setting up command post; taking care of wounded by first-aid, caring for, and moving patients; 5. recovery: including environment cleaning, recovery, and rebuilding. ideally, after the resilient community is established, it should consistently and spontaneously operate by itself; nevertheless, this is usually not the case in reality. without the government's supervision or expert's assistance, some communities fail to keep on with the work. to avoid it, the ntpc government designed a simple performance tracking table (table 4 ) and asks the community to fill it in whenever a disaster happens or is expected to come. the table is separated into 5 operation types, valid not only for operation during the disaster event but also for mitigation measures on normal days. the following are some suggested actions that the community can take. checking the drainage fence the water level is normal in the drainage system near jiaqing bridge as shown in table 3 , the population is aging in ntpc rural areas. young people leave their hometown to seek more work opportunities, which leave the elders more vulnerable to disasters. the aging population is not a unique problem to taiwan. many developed countries, such as japan, italy, finland, portugal, and greece, have this kind of social problem. responding to disaster requires mobile manpower to execute the tasks as designated in table 1 . to have more young people engage as shown in table 3 , the population is aging in ntpc rural areas. young people leave their hometown to seek more work opportunities, which leave the elders more vulnerable to disasters. the aging population is not a unique problem to taiwan. many developed countries, such as japan, italy, finland, portugal, and greece, have this kind of social problem. responding to disaster requires mobile manpower to execute the tasks as designated in table 1 . to have more young people engage in community-based disaster management, the government should help improve the employment market in rural areas to attract young residents' return or stay. it also implies the inseparability of disaster-related and social-economic issues in the era of public engagement in disaster management. it takes a disaster to learn a lesson. however, most people never really suffer from a medium to large scale disaster, not to mention a catastrophic one. what is taught in the resilient community workshop is the concept of self-help and mutual-help, as well as basic response skills. we never know if the residents could apply the concepts and skills perfectly during a disaster event. therefore, the retraining courses should be hosted persistently. moreover, most of the public lacks the experience of dealing with post-disaster recovery. it is time for the community to participate in pre-disaster recovery planning with the government to envision the potential damage and associated recovery work. after the entire training of a resilient community, most residents recognize its necessity and are willing to continue running it. the only problem is where the funding support comes from for consistent operation. although the ntpc government offers the community certain equipment, it is usually not enough regarding the regular operation, emergency response, and administrative works. more funding contributions from public and private sectors shall be needed. the government should put more effort into matchmaking between the needs of the communities and the resources from enterprises. extracting from ntpc experience, this research has proposed the sop to promote the resilient community, identified the key obstacles, suggested the maintenance mechanism, and shown the successful formulation of the local disaster management network. the policy to deal with disaster in ntpc is the "top-down" guidance with "bottom-up" implementation. in this manner, responsibilities and initiatives could be well balanced between residents and the government [14] . the network involves the community, local government, district office, school, and enterprise. those network members are invited to join the workshops and associated training for collaborative learning and developing a viable joint action plan. therefore, it is expected that, during a major incident or disaster (mid), the resilient community, school and enterprise could all play a role when the local government requires flexible surge capacity (fsc). surge capacity (sc) means the ability to increase staff, stuff, structure, and system (4s) rapidly and effectively in the affected areas. fsc indicates the capability to scale up and down resources in a fast, smooth, and productive way [15] . the community could provide manpower to help local government in many ways such as, but not limited to, evacuating vulnerable people, opening shelters, managing living supplies/materials, and identifying disaster hotspots. with that assistance, the government could focus more on addressing hardest-hit areas and situations. since this study shows a promising non-structural method to enhance the local disaster management network, any country or government willing to intensify the capacity of disaster management at the community level could follow ntpc's steps and avoid the obstacles. mitigation: including routine education, skill training, drill/war game, environment patrol, disaster information; 2. preparedness: including hosting preparedness meeting, equipment inventory, real-time weather monitoring and early warning, checking vulnerable people's condition and need once the disaster is spotted, reporting to the community and the authority concerned for timely response, as well as to associated private sectors such as water company or power company for assistance response: including dealing with disasters such as removing fallen trees, fire-fighting, identifying risk area and setting up cordon; evacuating people in the high-risk area; helping public sectors such as opening shelter, traffic control, and setting up command post; taking care of wounded by first-aid, caring for recovery: including environment cleaning, recovery, and rebuilding. operation process note central weather bureau issued the land waring of typhoon mitag at 20:30 garbage accumulated at the drainage fence in lane 518, liancheng rd. was reported to the district office, and removed by the cleaning contractor no garbage spotted in the gutter along lane 456 the water level is normal in the drainage system near jiaqing bridge united nations office for disaster risk reduction (undrr, formally unisdr) japan association for fire science and engineering. fire investigation of southern earthquake in hyogo prefecture in 1995, japan community capitals as community resilience to climate change: conceptual connections community advantage and individual self-efficacy promote disaster preparedness: a multilevel model among persons with disabilities applying community resilience theory to engagement with residents facing cumulative environmental exposure risks: lessons from louisiana's industrial corridor analysis of the actions and motivations of a community during the 2017 torrential rains in northern kyushu building resilience during recovery: lessons from colorado's watershed resilience pilot program. environ. manag. 2020, 66, 15 are cities aware enough? a framework for developing city awareness to climate change a typology of community flood resilience ministry of the interior. assessment of the problem and preparedness of metropolitan taipei during a large scale earthquake new taipei city fire department. resilient community operation manual understanding the operational concept of a flood-resilient urban community in jakarta, indonesia, from the perspectives of disaster risk reduction, climate change adaptation, and development agencies a case study of university involvement in community-based reconstruction: in the coventry university model. community-based reconstruction of society bottom-up citizen initiatives as emergent actors in flood risk management: mapping roles, relations and limitations flexible surge capacity-public health, public education, and disaster management this article is an open access article distributed under the terms and conditions of the creative commons attribution (cc by) license acknowledgments: this research was supported by the ministry of science and technology (most), taiwan, through project most 108-2119-m002-015. the authors declare no conflicts of interest.int. j. environ. res. public health 2020, 17, 5357 garbage accumulated at the drainage fence in lane 518, liancheng rd. was reported to the district office, and removed by the cleaning contractor. no garbage spotted in the gutter along lane 456, liancheng rd. the water level is normal in the drainage system near jiaqing bridge. no flooding in the mrt construction site. the water level is normal in the drainage system near jiaqing bridge as shown in table 3 , the population is aging in ntpc rural areas. young people leave their hometown to seek more work opportunities, which leave the elders more vulnerable to disasters. the aging population is not a unique problem to taiwan. many developed countries, such as japan, italy, finland, portugal, and greece, have this kind of social problem. responding to disaster requires mobile manpower to execute the tasks as designated in table 1 as shown in table 3 , the population is aging in ntpc rural areas. young people leave their hometown to seek more work opportunities, which leave the elders more vulnerable to disasters. the aging population is not a unique problem to taiwan. many developed countries, such as japan, italy, finland, portugal, and greece, have this kind of social problem. responding to disaster requires mobile manpower to execute the tasks as designated in table 1 as shown in table 3 , the population is aging in ntpc rural areas. young people leave their hometown to seek more work opportunities, which leave the elders more vulnerable to disasters. the aging population is not a unique problem to taiwan. many developed countries, such as japan, italy, finland, portugal, and greece, have this kind of social problem. responding to disaster requires mobile manpower to execute the tasks as designated in table 1 key: cord-186031-b1f9wtfn authors: caldarelli, guido; nicola, rocco de; petrocchi, marinella; pratelli, manuel; saracco, fabio title: analysis of online misinformation during the peak of the covid-19 pandemics in italy date: 2020-10-05 journal: nan doi: nan sha: doc_id: 186031 cord_uid: b1f9wtfn during the covid-19 pandemics, we also experience another dangerous pandemics based on misinformation. narratives disconnected from fact-checking on the origin and cure of the disease intertwined with pre-existing political fights. we collect a database on twitter posts and analyse the topology of the networks of retweeters (users broadcasting again the same elementary piece of information, or tweet) and validate its structure with methods of statistical physics of networks. furthermore, by using commonly available fact checking software, we assess the reputation of the pieces of news exchanged. by using a combination of theoretical and practical weapons, we are able to track down the flow of misinformation in a snapshot of the twitter ecosystem. thanks to the presence of verified users, we can also assign a polarization to the network nodes (users) and see the impact of low-quality information producers and spreaders in the twitter ecosystem. propaganda and disinformation have a history as long as mankind, and the phenomenon becomes particularly strong in difficult times, such as wars and natural disasters. the advent of the internet and social media has amplified and made faster the spread of biased and false news, and made targeting specific segments of the population possible [7] . for this reason the vice-president of the european commission with responsibility for policies on values and transparency, vȇra yourová, announced, beginning of june 2020, a european democracy action plan, expected by the end of 2020, in which web platforms admins will be called for greater accountability and transparency, since 'everything cannot be allowed online' [16] . manufacturers and spreaders of online disinformation have been particularly active also during the covid-19 pandemic period (e.g., writing about bill gates role in the pandemics or about masks killing children [2, 3] ). this, alongside the real pandemics [17] , has led to the emergence of a new virtual disease: covid-19 infodemics. in this paper, we shall consider the situation in italy, one of the most affected countries in europe, where the virus struck in a devastating way between the end of february and the end of april [1] . in such a sad and uncertain time, propaganda [1] in italy, since the beginning of the pandemics and at time of writing, almost 310k persons have contracted the covid-19 virus: of these, more than 35k have died. source: http://www.protezionecivile.gov.it/. accessed september 28, 2020. has worked hard: one of the most followed fake news was published by sputnik italia receiving 112,800 likes, shares and comments on the most popular social media. 'the article falsely claimed that poland had not allowed a russian plane with humanitarian aid and a team of doctors headed to italy to fly over its airspace', the ec vice-president yourová said. actually, the studies regarding dis/mis/information diffusion on social media seldom analyse its effective impact. in the exchange of messages on online platforms, a great amount of interactions do not carry any relevant information for the understanding of the phenomenon: as an example, randomly retweeting viral posts does not contribute to insights on the sharing activity of the account. for determining dis/misinformation propagation two main weapons can be used, the analysis of the content (semantic approach) and the analysis of the communities sharing the same piece of information (topological approach). while the content of a message can be analysed on its own, the presence of some troublesome structure in the pattern of news producer and spreaders (i.e., in the topology of contacts) can be detected only trough dedicated instruments. indeed, for real in-depth analyses, the properties of the real system should be compared with a proper null model. recently, entropy-based null models have been successfully employed to filter out random noise from complex networks and focus the attention on non trivial contributions [10, 26] . essentially, the method consists in defining a 'network benchmark' that has some of the (topological) properties of the real system, but is completely random for all the rest. then, every observation that does not agree with the model, i.e., cannot be explained by the topological properties of the benchmark, carries non trivial information. notably, being based on the shannon entropy, the benchmark is unbiased by definition. in the present paper, using entropy-based null-models, we analyse a tweet corpus related to the italian debate on covid-19 during the two months of maximum crisis in italy. after cleaning the system from the random noise, by using the entropy-based null-model as a filter, we have been able to highlight different communities. interestingly enough, these groups, beside including several official accounts of ministries, health institutions, and -online and offline -newspapers and newscasts, encompass four main political groups. while at first sight this may sound surprising -the pandemic debate was more on a scientific than on a political ground, at least in the very first phase of its abrupt diffusion -, it might be due to pre-existing echo chambers [18] . the four political groups are found to perform completely different activities on the platform, to interact differently from each other, and to post and share reputable and non reputable sources of information with great differences in the number of their occurrences. in particular, the accounts from the right wing community interact, mainly in terms of retweets, with the same accounts who interact with the mainstream media. this is probably due to the strong visibility given by the mainstream media to the leaders of that community. moreover, the right wing community is more numerous and more active, even relatively to the number of accounts involved, than the other communities. interestingly enough, newly formed political parties, as the one of the former italian prime minister matteo renzi, quickly imposed their presence on twitter and on the online political debate, with a strong activity. furthermore, the different political parties use different sources for getting information on the spreading on the pandemics. to detect the impact of dis/misinformation in the debate, we consider the news sources shared among the accounts of the various groups. with a hybrid annotation approach, based on independent fact checking organisations and human annotation, we categorised such sources as reputable and non reputable (in terms of credibility of the published news and the transparency of the sources). notably, we experienced that a group of accounts spread information from non reputable sources with a frequency almost 10 times higher than that of the other political groups. and we are afraid that, due to the extent of the online activity of the members of this community, the spreading of such a volume of non reputable news could deceit public opinion. we collected circa 4.5m tweets in italian language, from february 21 st to april 20 th 2020 [2] . details about the political situation in italy during the period of data collection can be found in the supplementary material, section 1.1: 'evolution of the covid-19 pandemics in italy'. the data collection was keyword-based, with keywords related the covid-19 pandemics. twitter's streaming api returns any tweet containing the keyword(s) in the text of the tweet, as well as in its metadata. it is worth noting that it is not always necessary to have each permutation of a specific keyword in the tracking list. for example, the keyword 'covid' will return tweets that contain both 'covid19' and 'covid-19'. table 1 lists a subset of the considered keywords and hashtags. there are some hashtags that overlap due to the fact that an included keyword is a sub-string of another one, but we included both for completeness. the left panel of fig. 1 shows the network obtained by following the projection procedure described in section 5.1. the network resulting from the projection procedure will be called, in the rest of the paper, validated network. the term validated should not be confused with the term verified, which instead denotes a twitter user who has passed the formal authentication procedure by the social platform. in order to get the community of verified twitter users, we applied the louvain algorithm [5] to the data in the validated network. such an algorithm, despite being one of the most popular, is also known to be order dependent [19] . to get rid of this bias, we apply it iteratively n times (n being the number of the nodes) after reshuffling the order of the nodes. finally, we select the partition with the highest modularity. the network presents a strong community structure, composed by four main subgraphs. when analysing the emerging 4 communities, we find that they correspond to 1 right wing parties and media (in steel blue) 2 center left wing (dark red) 3 5 stars movement (m5s ), in dark orange 4 institutional accounts (in sky blue) details about the political situation in italy during the period of data collection can be found in the supplementary material, section 1.2: 'italian political situation during the covid-19 pandemics'. this partition in four subgroups, once examined in more details, presents a richer substructure, described in the right panel of fig. 1 . starting from the center-left wing, we can find a darker red community, including various ngos and various left oriented journalists, vips and pundits. a slightly lighter red sub-community turns out to be composed by the main politicians of the italian democratic party (pd), as well as by representatives from the european parliament (italian and others) and some eu commissioners. the violet red group is mostly composed by the representatives of italia viva, a new party founded by the former italian prime minister matteo renzi (december 2014 -february 2016). in golden red we can find the subcommunity of catholic and vatican groups. finally the dark violet red and light tomato subcommunities consist mainly of journalists. in turn, also the orange (m5s) community shows a clear partition in substructures. in particular, the dark orange subcommunity contains the accounts of politicians, parliament representatives and ministers of the m5s and journalists. in aquamarine, we can find the official accounts of some private and public, national and international, health institutes. finally, in the light slate blue subcommunity we can find various italian ministers as well as the italian police and army forces. similar considerations apply to the steel blue community. in steel blue, the subcommunity of center right and right wing parties (as forza italia, lega and fratelli d'italia). in the following, this subcommunity is going to be called as fi-l-fdi, recalling the initials of the political parties contributing to this group. the sky blue subcommunity includes the national federations of various sports, the official accounts of athletes and sport players (mostly soccer) and their teams. the teal subcommunity contains the main italian news agencies. in this subcommunity there are also the accounts of many universities. the firebrick subcommunity contains accounts related to the as roma football club; analogously in dark red official accounts of ac milan and its players. the slate blue subcommunity is mainly composed by the official accounts of radio and tv programs of mediaset, the main private italian broadcasting company. finally, the sky blue community is mainly composed by italian embassies around the world. for the sake of completeness, a more detailed description of the composition of the subcommunities in the right panel of figure 1 is reported in the supplementary material, section 1.3: 'composition of the subcommunities in the validated network of verified twitter users'. here, we report a series of analyses related to the domain names, hereafter simply called domains, that mostly appear in all the tweets of the validated network of verified users. the domains have been tagged according to their degree of credibility and transparency, as indicated by the independent software toolkit newsguard https://www.newsguardtech.com/. the details of this procedure are reported below. as a first step, we considered the network of verified accounts, whose communities and sub-communities are shown in fig. 1 . on this topology, we labelled all domains that had been shared at least 20 times (between tweets and retweets). table 2 shows the tags associated to the domains. in the rest of the paper, we shall be interested in quantifying reliability of news sources publishing during the period of interest. thus, for our analysis, we will not consider those sources corresponding to social networks, marketplaces, search engines, institutional sites, etc. tags r, ∼ r and nr in table 2 are used only for news sites, be them newspapers, magazines, tv or radio social channels, and they stand for reputable, quasi reputable, not reputable, respectively. label unc is assigned to those domains with less than 20 occurrences in ours tweets and rewteets dataset. in fact, the labeling procedure is a hybrid one. as mentioned above, we relied on newsguard, a plugin resulting from the joint effort of journalists and software table 2 tags used for labeling the domains developers aiming at evaluating news sites according to nine criteria concerning credibility and transparency. for evaluating the credibility level, the metrics consider whether the news source regularly publishes false news, does not distinguish between facts and opinions, does not correct a wrongly reported news. for transparency, instead, the tool takes into account whether owners, founders or authors of the news source are publicly known; and whether advertisements are easily recognizable [3] . after combining the individual scores obtained out of the nine criteria, the plugin associates to a news source a score from 1 to 100, where 60 is the minimum score for the source to be considered reliable. when reporting the results, the plugin provides details about the criteria which passed the test and those that did not. in order to have a sort of no-man's land and not to be too abrupt in the transition between reputability and non-reputability, when the score was between 55 and 65, we considered the source to be quasi reputable, ∼r. it is worth noting that not all the domains in the dataset under investigation were evaluated by newsguard at the time of our analysis. for those not evaluated automatically, the annotation was made by three tech-savvy researchers, who assessed the domains by using the same criteria as newsguard. table 3 gives statistics about number and kind of tweets (tw = pure tweet; rt = retweet), the number of url and distinct url (dist url), the number of domains and users in the validated network of verified users. we clarify what we mean by these terms with an example: a domain for us corresponds to the so-called 'second-level domain' name [4] , i.e., the name directly to the left of .com, .net, and any other top-level domains. for instance, repubblica.it, corriere.it, nytimes.com are considered domains by us. instead, the url maintains here its standard definition [5] and an example is http://www.example.com/index.html. table 4 shows the outcome of the domains annotation, according to the scores of newsguard or to those assigned by the three annotators, when scores were no available from newsguard. at a first glance, the majority of the news domains belong to the reputable category. the second highest percentage is the one of the untagged domains -unc. in fact, in our dataset there are many domains that occur only few times once. for example, there are 300 domains that appear in the datasets only once. fig. 2 shows the trend of the number of tweets and retweets, containing urls, posted by the verified users of the validated projection during the period of data [3] newsguard rating process: https://www.newsguardtech.com/ratings/rating-process-criteria/ [4] https://en.wikipedia.org/wiki/domain_name [5] table 4 annotation results over all the domains in the whole dataset -validated network of verified users. in [9] . going on with the analysis, table 5 shows the percentage of the different types of domains for the 4 communities identified in the left plot of fig. 1 . it is worth observing that the steel blue community (both politicians and media) is the most active one, even if it is not the most represented: the number of users is lower than the one of the center left community (the biggest one, in terms of numbers), but the number of their posts containing a valid url is almost the double of that of the second more active community. interestingly, the activity of the verified users of the steel blue community is more focused on content production of (see the only tweets sub-table) than in sharing (see the only retweets sub-table). in fact, retweets represent almost 14.6% of all posts from the media and the right wing community, while in the case of the center-left community it is 34.5%. this effect is observable even in the average only tweets post per verified user: a right-wing user and a media user have an average of 88.75 original posts, against 34.27 for center-left-wing users. these numbers are probably due to the presence in the former community of the italian most accessed media. they tend to spread their (original) pieces of news on the twitter platform. interestingly, the presence of urls from a non reputable source in the steel blue community is more than 10 times higher than the second score in the same field in the case of original tweets (only tweets). it is worth noting that, for the case of the dark orange and sky blue communities, which are smaller both in terms of users and number of posts, the presence of non classified sources is quite strong (it represents nearly 46% of retweeted posts for both the communities), as it is the frequency of posts linking to social network contents. interestingly enough, the verified users of both groups seem to focus slightly more on the same domains: there are, on average, 1.59 and 1.80 posts for each url domain respectively for the dark orange and sky blue communities, and, on average, 1.26 and 1.34 posts for the steel blue and the dark red communities. the right plot in fig. 1 report a fine grained division of communities: the four largest communities have been further divided into sub-communities, as mentioned in subsection 3.1. here, we focus on the urls shared in the purely political sub-communities in table 7 . broadly speaking, we examine the contribution of the different political parties, as represented on twitter, to the spread of mis/disinformation and propaganda. table 7 clearly shows how the vast majority of the news coming from sources considered scarce or non reputable are tweeted and retweeted by the steel blue political sub-community (fi-l-fdi). notably, the percentage of non reputable sources shared by the fi-l-fdi accounts is more than 4 times the percentage of their community (the steel blue one) and it is more than 30 times the second community in the nr ratio ranking. for all the political sub-communities the incidence of social network links is much higher than in their original communities. looking at table 8 , even if the number of users in each political sub-community is much smaller, some peculiar behaviours can be still be observed. again, the center-right and right wing parties, while representing the least represented ones in terms of users, are much more active than the other groups: each (verified) user is responsible, on average of almost 81.14 messages, while the average is 23.96, 22.12 and 15.29 for m5s, iv and pd, respectively. it is worth noticing that italia viva, while being a recently founded party, is very active; moreover, for them the frequency of quasi reputable sources is quite high, especially in the case of only tweets posts. the impact of uncategorized sources is almost constant for all communities in the retweeting activity, while it is particularly strong for the m5s. finally, the posts by the center left communities (i.e., italia viva and the democratic party) tend to have more than one url. specifically, every post containing at least a url, has, on average, 2.05 and 2.73 urls respectively, against the 1.31 of movimento 5 stelle and 1.20 for the center-right and right wing parties. to conclude the analysis on the validated network of verified users, we report statistics about the most diffused hashtags in the 4 political sub-communities. fig. 3 focuses on wordclouds, while fig. 4 reports the data under an histograms form. actually, from the various hashtags we can derive important information regarding the communications of the various political discursive communities and their position towards the management of the pandemics. first, it has to be noticed that the m5s is the greatest user of hashtags: their two most used hashtags have been used almost twice the most used hashtags used by the pd, for instance. this heavy usage is probably due to the presence in this community of journalists and of the official account of il fatto quotidiano, a newspaper explicitly supporting the m5s: indeed, the first two hashtags are "#ilfattoquotidiano" and "#edicola" (kiosk, in italian). it is interesting to see the relative importance of hashtags intended to encourage the population during the lockdown: it is the case of "#celafaremo" (we will make it), "#iorestoacasa" (i am staying home), "#fermiamoloinsieme" (let's stop it together ): "#iorestoacasa" is present in every community, but it ranks 13th in the m5s verified user community, 29th in the fi-l-fdi community, 2nd in the italia viva community and 10th in the pd one. remarkably, "#celafaremo" is present only in the m5s group, as "#fermiamoloinsieme" can be found in the top 30 hashtags only in the center-right and right wing cluster. the pd, being present in various european institutions, mentions more european related hashtags ("#europeicontrocovid19", europeans against covid-19 ), in order to ask for a common reaction of the eu. the center-right and right wing community has other hashtags as "#forzalombardia" (go, lombardy! ), ranking the 2nd, and "#fermiamoloinsieme", ranking 10th. what is, nevertheless, astonishing, is the presence among the most used hashtags of all communities of the name of politicians from the same group ('interestingly '#salvini" is the first used hashtag in the center right and right wing community, even if he did not perform any duty in the government), tv programs ("#mattino5", "#lavitaindiretta", "#ctcf", "#dimartedì"), as if the main usage of hashtags is to promote the appearance of politicians in tv programs. finally, the hashtags used by fi-l-fdi are mainly used to criticise the actions of the government, e.g., "#contedimettiti" (conte, resign! ). fig. 5 shows the structure of the directed validated projection of the retweet activity network, as outcome of the procedure recalled in section 3 of the supplementary material. as mentioned in section 4 of the supplementary material, the affiliation of unverified users has been determined using the tags obtained by the validated projected network of the verified users, as immutable label for the label propagation of [23] . after label propagation, the representation of the political communities in the validated retweet network changes dramatically with respect to the case of the network of verified users: the center-right and right wing community is the most represented community in the whole network, with 11063 users (representing 21.1% of all the users in the validated network), followed by italia viva users with 8035 accounts (15.4% of all the accounts in the validated network). the impact of m5s and pd is much more limited, with, respectively, 3286 and 564 accounts. it is worth noting that this result is unexpected, due to the recent formation of italia viva. as in our previous study targeting the online propaganda [8] , we observe that the most effective users in term of hub score [21] are almost exclusively from the center-right and right wing party: considering the first 100 hubs, only 4 are not from this group. interestingly, 3 out of these 4 are verified users: roberto burioni, one of the most famous italian virologists, ranking 32nd, agenzia ansa, a popular italian news agency, ranking 61st, and tgcom24, the popular newscast of a private tv channel, ranking 73rd. the fourth account is an online news website, ranking 88th: this is a not verified account which belongs to a not political community. remarkably, in the top 5 hubs we find 3 of the top 5 hubs already found when considered the online debate on migrations from northern africa to italy [8] : in particular, a journalist of a neo-fascist online newspaper (non verified user), an extreme right activist (non verified user) and the leader of fratelli d'italia giorgia meloni (verified user), who ranks 3rd in the hub score. matteo salvini (verified user), who was the first hub in [8] , ranks 9th, surpassed by his party partner claudio borghi, ranking 6th. the first hub in the present network is an extreme right activist, posting videos against african migrants to italy and accusing them to be responsible of the contagion and of violating lockdown measures. table 9 shows the annotation results of all the domains tweeted and retweeted by users in the directed validated network. the numbers are much higher than those shown in table 2 , but the trend confirms the previous results. the majority of urls traceable to news sources are considered reputable. the number of unclassified domains is higher too. in fact, in this case, the annotation was made considering the domains occurring at least 100 times. table 9 annotation results over all the domains -directed validated network table 10 reports statistics about posts, urls, distinct urls, users and verified users in the directed validated network. noticeably, by comparing these numbers with those of table 3 , reporting statistics about the validated network of verified users, we can see that here the number of retweets is much more higher, and the trend is the opposite: verified users tend to tweet more than retweet (46277 vs 17190), while users in the directed validated network, which comprehends also non verified users, have a number of retweets 3.5 times higher than the number of their tweets. fig. 6 shows the trend of the number of tweets containing urls over the period of data collection. since we are analysing a bigger network than the one considered in section 3.2, we have numbers that are one order of magnitude greater than those shown in fig. 2 ; the highest peak, after the discovery of the first cases in lombardy, corresponds to more than 68,000 posts containing urls, whereas the analogous peak in fig. 2 corresponds to 2,500 posts. apart from the order of magnitudes, the two plots feature similar trends: higher traffic before the beginning of the italian lockdown, and a settling down as the quarantine went on [6] . table 11 shows the core of our analysis, that is, the distribution of reputable and non reputable news sources in the direct validated network, consisting of both verified and non-verified users. again, we focus directly on the 4 political sub-communities identified in the previous subsection. two of the sub-communities are part of the center-left wing community, one is associated to the 5 stars movement, the remaining one represents center-right and right wing communities. in line with previous results on the validated network of verified users, the table clearly shows how the vast majority of the news coming from sources considered scarce or non reputable are tweeted and retweeted by the center-right and right wing communities; 98% of the domains tagged as nr are shared by them. as shown in table 12 , the activity of fi-l-fdi users is again extremely high: on average there are 89.3 retweets per account in this community, against the 66.4 of m5s, the 48.4 of iv and the 21.8 of pd. the right wing contribution to the debate is extremely high, even in absolute numbers, due to the the large number of users in this community. it is worth mentioning that the frequency of non reputable sources in this community is really high (at about 30% of the urls in the only tweets) and comparable with that of the reputable ones (see table 11 , only [6] the low peaks for february 27 and march 10 are due to an interruption in the data collection, caused by a connection breakdown. table 11 domains annotation per political sub-communities -directed validated network tweets). in the other sub-communities, pd users are more focused on un-categorised sources, while users from both italia viva and movimento 5 stelle are mostly tweeting and retweeting reputable news sources. and users, but also in absolute numbers: out of the over 1m tweets, more than 320k tweets refer to a nr url. actually, the political competition still shines through the hashtag usage even for the other communities: it is the case, for instance, of italia viva. in the top 30 hashtags we can find '#salvini', '#lega', but also '#papeete' [7] , '#salvinisciacallo' (salvini jackal ) and '#salvinimmmerda' (salvini asshole). on the other hand, in italia viva hashtags supporting the population during the lockdown are used: '#iorestoacasa', '#restoacasa' (i am staying home), '#restiamoacasa' (let's stay home). criticisms towards the management of lombardy health system during the pandemics can be deduced from the hashtag '#commissariamtelalombardia' (put lombardy under receivership) and '#fontana' (the lega administrator of the lombardy region). movimento 5 stelle has the name of the main leader of the opposition '#salvini', as first hashtag and supports criticisms to the lombardy administration with the hashtags '#fontanadimettiti' (fontana, resign! ) and '#gallera', the health and welfare minister of the lombardy region, considered the main responsible for the bad management of the pandemics. nevertheless, it is possible to highlight even some hashtags encouraging the population during the lock down, as the above mentioned '#iorestoacasa', '#restoacasa' and '#restiamoacasa'. it is worth mentioning that the government measures, and the corresponding m5s campaigns, are accompanied specific hashtags: '#curaitalia' is the name of one of the decree of the prime minister to inject liquidity in the italian economy, '#acquistaitaliano' (buy italian products! ), instead, advertise italian products to support the national economy. as a final task, over the whole set of tweets produced or shared by the users in the directed validated network, we counted the number of times a message containing a url was shared by users belonging to different political communities, although without considering the semantics of the tweets. namely, we ignored whether the urls were shared to support or to oppose the presented arguments. table 14 shows the most tweeted (and retweeted) nr domains shared by the political communities presented in table 7 , the number of occurrences is reported next to each domain. the first nr domains for fi-l-fdi in table 14 are related to the right, extreme right and neo-fascist propaganda, as it is the case of imolaoggi.it, ilprimatonazionale.it and voxnews.info, recognised as disinformation websites by newsguard and by the two main italian debunker websites, bufale.net and butac.it. as shown in the table, some domains, although in different number of occurrences, are present under more than one column, thus shared by users close to different political communities. this could mean, for some subgroups of the community, a retweet with the aim of supporting the opinions expressed in the original tweets. however, since the semantics of the posts in which these domains are present were not investigated, the retweets of the links by more than one political community could be due to contrast, and not to support, the opinions present in the original posts. despite the fact that the results were achieved for a specific country, we believe that the applied methodology is of general interest, being able to show trends and peculiarities whenever information is exchanged on social networks. in particular, when analysing the outcome of our investigation, some features attracted our attention: 1 persistence of clusters wrt different discussion topics: in caldarelli et al. [8] , we focused on tweets concerned with immigration, an issue that has been central in the italian political debate for years. here, we discovered that the clusters and the echo chambers that have been detected when analysing tweets about immigration are almost the same as those singled out when considering discussions concerned with covid-19. this may seem surprising, because a discussion about covid-19 may not be exclusively political, but also medical, social, economic, etc.. from this we can argue that the clusters are political in nature and, even when the topic of discussion changes, users remain in their cluster on twitter. (indeed, journalists and politicians use twitter for information and political propaganda, respectively). the reasons political polarisation and political vision of the world affect so strongly also the analysis of what should be an objective phenomenon is still an intriguing question. 2 persistence of online behavioral characteristics of clusters: we found that the most active, lively and penetrating online communities in the online debate on covid-19 are the same found in [8] , formed in a almost purely political debate such as the one represented by the right of migrants to land on the italian territory. 3 (dis)similarities amongst offline and online behaviours of members and voters of parties: maybe less surprisingly, the political habits is also reflected in the degree of participation to the online discussions. in particular, among the parties in the centre-left-wing side, a small party (italia viva) shows a much more effective social presence than the larger party of the italian centre-left-wing (partito democratico), which has many more active members and more parliamentary representation. more generally, there is a significant difference in social presence among the different political parties, and the amount of activity is not at all proportional to the size of the parties in terms of members and voters. 4 spread of non reputable news sources: in the online debate about covid-19, many links to non reputable (defined such by newsguard, a toolkit ranking news website based on criteria of transparency and credibility, led by veteran journalists and news entrepreneurs) news sources are posted and shared. kind and occurrences of the urls vary with respect to the corresponding political community. furthermore, some of the communities are characterised by a small number of verified users that corresponds to a very large number of acolytes which are (on their turn) very active, three times as much as the acolytes of the opposite communities in the partition. in particular, when considering the amount of retweets from poorly reputable news sites, one of the communities is by far (one order of magnitude) much more active than the others. as noted already in our previous publication [8] , this extra activity could be explained by a more skilled use of the systems of propaganda -in that case a massive use of bot accounts and a targeted activity against migrants (as resulted from the analysis of the hub list). our work could help in steering the online political discussion around covid-19 towards an investigation on reputable information, while providing a clear indication of the political inclination of those participating in the debates. more generally, we hope that our work will contribute to finding appropriate strategies to fight online misinformation. while not completely unexpected, it is striking to see how political polarisation affects also the covid-19 debate, giving rise to on-line communities of users that, for number and structure, almost closely correspond to their political affiliations. this section recaps the methodology through which we have obtained the communities of verified users (see section 3.1). this methodology has been designed in saracco et al. [25] and applied in the field of social networks for the first time in [4, 8] . for the sake of completeness, the supplementary material, section 3, recaps the methodology through which we have obtained the validated retweet activity network shown in section 3.3. in section 4 of the supplementary material, the detection of the affiliation of unverified users is described. in the supplementary material, the interested reader will also find additional details about 1) the definition of the null models (section 5); 2) a comparison among various label propagation for the political affiliation of unverified users (section 6); and 3) a brief state of the art on fact checking organizations and literature on false news detection (section 7). many results in the analysis of online social networks (osn) shows that users are highly clustered in group of opinions [1, 11-15, 22, 28, 29] ; indeed those groups have some peculiar behaviours, as the echo chamber effects [14, 15] . following the example of references [4, 8] , we are making use of this users' clustering in order to detect discursive community, i.e. groups of users interacting among themselves by retweeting on the same (covid-related) subjects. remarkably, our procedure does not follow the analysis of the text shared by the various users, but is simply related on the retweeting activity among users. in the present subsection we will examine how the discursive community of verified twitter users can be extracted. on twitter there are two distinct categories of accounts: verified and unverified users. verified users have a thick close to the screen name: the platform itself, upon request from the user, has a procedure to check the authenticity of the account. verified accounts are owned by politicians, journalists or vips in general, as well as the official accounts of ministers, newspapers, newscasts, companies and so on; for those kind of users, the verification procedure guarantees the identity of their account and reduce the risk of malicious accounts tweeting in their name. non verified accounts are for standard users: in this second case, we cannot trust any information provided by the users. the information carried by verified users has been studied extensively in order to have a sort of anchor for the related discussion [4, 6, 8, 20, 27] to detect the political orientation we consider the bipartite network represented by verified (on one layer) and unverified (on the other layer) accounts: a link is connecting the verified user v with the unverified one u if at least one time v was retweeted by u, or viceversa. to extract the similarity of users, we compare the commonalities with a bipartite entropy-based null-model, the bipartite configuration model (bicm [24] ). the rationale is that two verified users that share many links to same unverified accounts probably have similar visions, as perceived by the audience of unverified accounts. we then apply the method of [25] , graphically depicted in fig. 8 , in order to get a statistically validated projection of the bipartite network of verified and unverified users. in a nutshell, the idea is to compare the amount of common linkage measured on the real network with the expectations of an entropy-based null model fixing (on average) the degree sequence: if the associated p-value is so low that the overlaps cannot be explained by the model, i.e. such that it is not compatible with the degree sequence expectations, they carry non trivial information and we project the related information on the (monopartite) projection of verified users. the interested reader can find the technical details about this validated projection in [25] and in the supplementary information. the data that support the findings of this study are available from twitter, but restrictions apply to the availability of these data, which were used under license 1 italian socio-political situation during the period of data collection in the present subsection we present some crucial facts for the understanding of the social context in which our analysis is set. this subsection is divided into two parts: the contagion evolution and the political situation. these two aspects are closely related. a first covid-19 outbreak was detected in codogno, lodi, lombardy region, on february, 19th [1] . in the very next day, two cases were detected in vò, padua, veneto region. on february, 22th, in order to contain the contagions, the national government decided to put in quarantine 11 municipalities, 10 in the area around lodi and vò, near padua [2] . nevertheless, the number of contagions raised to 79, hitting 5 different regions; one of the infected person in vò died, representing the first registered italian covid-19 victim [3] . on february, 23th there were already 229 confirmed cases in italy. the first lockdown should have lasted until the 6th of march, but due to the still increasing number of contagions in northern italy, the italian prime minister giuseppe conte intended to extend the quarantine zone to almost all the northern italy on sunday, march 8th [4] : travel to and from the quarantine zone were limited to case of extreme urgency. a draft of the decree announcing the expansion of the quarantine area appeared on the website of the italian newspaper corriere della sera on the late evening of saturday, 7th, causing some panic in the interested areas [5] : around 1000 people, living in milan, but coming from southern regions, took trains and planes to reach their place of [1] prima lodi, ""paziente 1", il merito della diagnosi va diviso... per due", 8th june 2020 [2] italian gazzetta ufficiale, "decreto-legge 23 febbraio 2020, n. 6". the date is intended to be the very first day of validity of the decree. [3] il fatto quotidiano, "coronavirus,è morto il 78enne ricoverato nel padovano. 15 contagiati in lombardia, un altro in veneto", 22nd february 2020. [4] bbc news, "coronavirus: northern italy quarantines 16 million people", 8th march 2020" [5] the guardian, "leaked coronavirus plan to quarantine 16m sparks chaos in italy", 8th march 2020 origins [6] [7] . in any case, the new quarantine zone covered the entire lombardy and partially other 4 regions. remarkably, close to bergamo, lombardy region, a new outbreak was discovered and the possibility of defining a new quarantine area on march 3th was considered: this opportunity was later abandoned, due to the new northern italy quarantine zone of the following days. this delay seems to have caused a strong increase in the number of contagions, making the bergamo area the most affected one, in percentage, of the entire country [8] ; at time of writing, there are investigations regarding the responsibility of this choice. on march, 9th, the lockdown was extended to the whole country, resulting in the first country in the world to decide for national quarantine [9] . travels were restricted to emergency reason or to work; all business activities that were not considered as essentials, as pharmacies and supermarkets, had to be closed. until the 21st of march lockdown measures became progressively stricter all over the country. starting from the 14th of april, some retails activities as children clothing shops, reopened. a first fall in the number of deaths was observed on the 20th of april [10] . a limited reopening started with the so-called "fase 2" (phase 2 ) on the 4th of may [11] . from the very first days of march, the limited capacity of the intensive care departments to take care of covid-infected patients, took to the necessity of a re-organization of italian hospitals, leading, e.g., to the opening of new intensive care departments [12] . moreover, new communication forms with the relatives of the patients were proposed, new criteria for the intubating patients were developed, and, in the extreme crisis, in the most infected cases, the emergency management took to give priority to the hospitalisation to patients with a higher probability to recover [13] . outbreaks were mainly present in hospitals [19] . unfortunately, healthcare workers were contaminated by the covid [14] . this contagion resulted in a relative high number of fatalities: by the 22nd of april, 145 covid deaths were registered among doctors. due to the pressure on the intensive care capacity, even the healthcare personnel was subject to extreme stress, especially in the most affected zones [15] . on august 8th, 2019, the leader of lega, the main italian right wing party, announced to negate the support to the government of giuseppe conte, which was formed after a post-election coalition between the renzi formed a new center-left party, italia viva (italy alive, iv), due to some discord with pd; despite the scission, italia viva continued to support the actual government, having some of its representatives among the ministers and undersecretaries, but often marking its distance respect to both pd and m5s. due to the great impact that matteo salvini and giorgia meloni -leader of fratelli d'italia, a right wing party-have on social media, they started a massive campaign against the government the day after its inauguration. the regions of lombardy, veneto, piedmont and emilia-romagna experienced the highest number of contagions during the pandemics; among those, the former 3 are administrated by the right and center-right wing parties, the fourth one by the pd. the disagreement in the management of the pandemics between regions and the central government was the occasion to exacerbate the political debate (in italy, regions have a quite wide autonomy for healthcare). the regions administrated by the right wing parties criticised the centrality of the decisions regarding the lock down, while the national government criticises the health management (in lombardy the healthcare system has a peculiar organisation, in which the private sector is supported by public funding) and its non effective measure to reduce the number of contagions. the debate was ridden even at a national level: the opposition criticized the financial origin of the support to the various economic sectors. moreover, the role of the european union in providing funding to recover italian economics after the pandemics was debated. here, we detail the composition of the communities shown in figure 1 of the main text. we remind the reader that, after applying the leuven algorithm to the validated network of verified twitter users, we could observe 4 main communities, that correspond to 1 right wing parties and media (in steel blue) 2 center left wing (dark red) 3 5 stars movement (m5s ), in dark orange 4 institutional accounts (in sky blue) starting from the center-left wing, we can find a darker red community, including various ngos (the italian chapters of unicef, medecins sans frontieres, action aid, emergency, save the children, etc.), various left oriented journalists, vips and pundits [16] . finally, we can find in this group political movements ('6000sardine') and politicians on the left of pd (as beppe civati, pietro grasso, ignazio marino) or on the left current of the pd (laura boldrini, michele emiliano, stefano bonaccini). a slightly lighter red sub-community turns out to be composed by the main politicians of the italian democratic party (pd), as well as by representatives from the european parliament (italian and others) and some eu commissioners. the violet red group is mostly composed by the representatives of the newly founded italia viva, by the former italian prime minister matteo renzi (december 2014 -february 2016) and former secretary of pd. in golden red we can find the subcommunity of catholic and vatican groups. finally the dark violet red and light tomato subcommunities are composed mainly by journalists. interestingly enough, the dark violet red contains also accounts related to the city of milan (the major, the municipality, the public services account) and to the spoke person of the chinese minister of foreign affair. in turn, also the orange (m5s) community shows a clear partition in substructures. in particular, the dark orange subcommunity contains the accounts of politicians, parliament representatives and ministers of the m5s and journalists and the official account of il fatto quotidiano, a newspaper supporting the movement 5 stars. interestingly, since one of the main leaders of the movement, luigi di maio, is also the italian minister of foreign affairs, we can find in this subcommunity also the accounts of several italian embassies around the world, as well as the account of the italian representatives at nato, ocse and oas. in aquamarine, we can find the official accounts of some private and public, national and international, health institutes (as the italian istituto superiore di sanità, literally the italian national institute of health, the world health organization, the fondazione veronesi) the minister of health roberto speranza, and some foreign embassies in italy. finally, in the light slate blue subcommunity we can find various italian ministers as well as the italian police and army forces. similar considerations apply to the steel blue community. in steel blue, the subcommunity of center right and right wing parties (as forza italia, lega and fratelli d'italia). the presidents of the regions of lombardy, veneto and liguria, administrated by center right and right wing parties, can be found here. (in the following this subcommunity is going to be called as fi-l-fdi, recalling the initials of the political parties contributing to this group.) the sky blue subcommunity includes the national federations of various sports, the official accounts of athletes and sport players (mostly soccer) and their teams, as well as sport journals, newscasts and journalists. the teal subcommunity contains the main italian news agencies, some of the main national and local newspapers, [16] as the cartoonists makkox and vauro, the singers marracash, frankiehinrg, ligabue and emphil volo vocal band, and journalists from repubblica (ezio mauro, carlo verdelli, massimo giannini), from la7 tv channel (ricardo formigli, diego bianchi). newscasts and their journalists. in this subcommunity there are also the accounts of many universities; interestingly enough, it includes also the all the local public service local newscasts. the firebrick subcommunity contains accounts related to the as roma football club; analogously in dark red official accounts of ac milan and its players. the slate blue subcommunity is mainly composed by the official accounts of radio and tv programs of mediaset, the main private italian broadcasting company, together with singers and musicians. other smaller subcommunities includes other sport federations, and sports pundits. finally, the sky blue community is mainly composed by italian embassies around the world. the navy subpartition contains also the official accounts of the president of the republic, the italian minister of defense and the one of the commissioner for economy at eu and former prime minister, paolo gentiloni. in the study of every phenomenon, it is of utmost importance to distinguish the relevant information from the noise. here, we remind a framework to obtain a validated monopartite retweet network of users: the validation accounts the information carried by not only the activity of the users, but also by the virality of their messages. we represented pictorially the method in fig. 1 . we define a directed bipartite network in which one layer is composed by accounts and the other one by the tweets. an arrow connecting a user u to a tweet t represents the u writing the message t. the arrow in the opposite direction means that the user u is retweeting the message t. to filter out the random noise from this network, we make use of the directed version of the bicm, i.e. the bipartite directed configuration model (bidcm [15] ). the projection procedure is then, analogous to the one presented in the previous subsection: it is pictorially displayed in the fig. 1 . briefly, consider the couple of users u 0 and u 1 and consider the number of message written by u 0 and shared u 1 . then, calculate which is the distribution of the same measure according with the bidcm: if the related p-value is statistically significant, i.e. if the number of u 0 's tweets shared by u 1 is much more than expected by the bidcm, we project a (directed) link from u 0 to u 1 . summarising, the comparison of the observation on the real network with the bidcm permits to uncover all contributions that cannot originate from the constraints of the null-model. using the technique described in subsection 5.1 of the main text, we are able to assign to almost all verified users a community, based on the perception of the unverified users. due to the fact that the identity of verified users are checked by twitter, we have the possibility of controlling our groups. indeed, as we will show in the following, the network obtained via the bipartite projection provides a reliable description regarding the closeness of opinions and role in the social debate. how can we use this information in order to infer the orientation of non verified users? in the reference [6] we used the tags obtained for both verified and unverified users in the bipartite network described in subsection 5.1 of the main real network c) e) figure 1 schematic representation of the projection procedure for bipartite directed network. a) an example of a real directed bipartite network. for the actual application, the two layers represent twitter accounts (turquoise) and posts (gray). a link from a turquoise node to a gray one represents that the post has been written by the user; a link in the opposite direction represents a retweet by the considered account. b) the bipartite directed configuration model (bidcm) ensemble is defined. the ensemble includes all the link realisations, once the number of nodes per layer has been fixed. c) we focus our attention on nodes i and j and count the number of directed common neighbours (in magenta both the nodes and the links to their common neighbours), i.e., the number of posts written by i and retweeted by j. subsequently, d) we compare this measure on the real network with the one on the ensemble: if this overlap is statistically significant with respect to the bidcm, e) we have a link from i to j in the projected network. text and propagated those labels accross the network. in a recent analysis, we observed that other approaches are more stable [16] : in the present manuscript we make use of the most stable algorithm. we use the label propagation as proposed in [22] on the directed validated network. indeed, the validated directed network in the present appendix we remind the main steps for the definition of an entropy based null model; the interested reader can refer to the review [8] . we start by revising the bipartite configuration model [23] , that has been used for detecting the network of similarities of verified users. we are then going to examine the extension of this model to bipartite directed networks [15] . finally, we present the general methodology to project the information contained in a -directed or undirected-bipartite network, as developed in [24] . let us consider a bipartite network g * bi , in which the two layers are l and γ. define g bi the ensemble of all possible graphs with the same number of nodes per layer as in g * bi . it is possible to define the entropy related to the ensemble as [20] : where p (g bi ) is the probability associated to the instance g bi . now we want to obtain the maximum entropy configuration, constraining some relevant topological information regarding the system. for the bipartite representation of verified and unverified user, a crucial ingredient is the degree sequence, since it is a proxy of the number of interactions (i.e. tweets and retweets) with the other class of accounts. thus in the present manuscript we focus on the degree sequence. let us then maximise the entropy (1), constraining the average over the ensemble of the degree sequence. it can be shown, [24] , that the probability distribution over the ensemble is where m iα represent the entries of the biadjacency matrix describing the bipartite network under consideration and p iα is the probability of observing a link between the nodes i ∈ l and α ∈ γ. the probability p iα can be expressed in terms of the lagrangian multipliers x and y for nodes on l and γ layers, respectively, as in order to obtain the values of x and y that maximize the likelihood to observe the real network, we need to impose the following conditions [13, 26]        where the * indicates quantities measured on the real network. actually, the real network is sparse: the bipartite network of verified and unverified users has a connectance ρ 3.58 × 10 −3 . in this case the formula (3) can be safely approximated with the chung-lu configuration model, i.e. where m is the total number of links in the bipartite network. in the present subsection we will consider the case of the extension of the bicm to direct bipartite networks and highlight the peculiarities of the network under analysis in this representation. the adjancency matrix describing a direct bipartite network of layers l and γ has a peculiar block structure, once nodes are order by layer membership (here the nodes on l layer first): where the o blocks represent null matrices (indeed they describe links connecting nodes inside the same layer: by construction they are exactly zero) and m and n are non zero blocks, describing links connecting nodes on layer l with those on layer γ and viceversa. in general m = n, otherwise the network is not distinguishable from an undirected one. we can perform the same machinery of the section above, but for the extension of the degree sequence to a directed degree sequence, i.e. considering the in-and out-degrees for nodes on the layer l, (here m iα and n iα represent respectively the entry of matrices m and n) and for nodes on the layer γ, the definition of the bipartite directed configuration model (bidcm, [15] ), i.e. the extension of the bicm above, follows closely the same steps described in the previous subsection. interestingly enough, the probabilities relative to the presence of links from l to γ are independent on the probabilities relative to the presence of links from γ to l. if q iα is the probability of observing a link from node i to node α and q iα the probability of observing a link in the opposite direction, we have where x out i and x in i are the lagrangian multipliers relative to the node i ∈ l, respectively for the out-and the in-degrees, and y out α and y in α are the analogous for α ∈ γ. in the present application we have some simplifications: the bipartite directed network representation describes users (on one layer) writing and retweeting posts (on the other layer). if users are on the layer l and posts on the opposite layer and m iα represents the user i writing the post α, then k in α = 1 ∀α ∈ γ, since each message cannot have more than an author. notice that, since our constraints are conserved on average, we are considering, in the ensemble of all possible realisations even instances in which k in α > 1 or k in α = 0, or, otherwise stated, non physical; nevertheless the average is constrained to the right value, i.e. 1. the fact that k in α is the same for every α allows for a great simplification of the probability per link on m: where n γ is the total number of nodes on the γ layer. the simplification in (9) is extremely helpful in the projected validation of the bipartite directed network [2] . the information contained in a bipartite -directed or undirected-network, can be projected onto one of the two layers. the rationale is to obtain a monopartite network encoding the non trivial interactions among the two layers of the original bipartite network. the method is pretty general, once we have a null model in which probabilities per link are independent, as it is the case of both bicm and bidcm [24] . the first step is represented by the definition of a bipartite motif that may capture the non trivial similarity (in the case of an undirected bipartite network) or flux of information (in the case of a directed bipartite network). this quantity can be captured by the number of v −motifs between users i and j [11, 23] , or by its direct extension (note that v ij = v ji ). we compare the abundance of these motifs with the null models defined above: all motifs that cannot be explained by the null model, i.e. whose p-value are statistically significance, are validated into the projection on one of the layers [24] . in order to assess the statistically significance of the observed motifs, we calculate the distribution associated to the various motifs. for instance, the expected value for the number of v-motifs connecting i and j in an undirected bipartite network is where p iα s are the probability of the bicm. analogously, where in the last step we use the simplification of (9) [2] . in both the direct and the undirect case, the distribution of the v-motifs or of the directed extensions is poisson binomial one, i.e. a binomial distribution in which each event shows a different probability. in the present case, due to the sparsity of the analysed networks, we can safely approximate the poisson-binomial distribution with a poisson one [14] . in order to state the statistical significance of the observed value, we calculate the related p-values according to the relative null-models. once we have a p-value for every detected v-motif, the related statistical significance can be established through the false discovery rate (fdr) procedure [3] . respect to other multiple test hypothesis, fdr controls the number of false positives. in our case, all rejected hypotheses identify the amount of v-motifs that cannot be explained only by the ingredients of the null model and thus carry non trivial information regarding the systems. in this sense, the validated projected network includes a link for every rejected hypothesis, connecting the nodes involved in the related motifs. in the main text, we solved the problem of assigning the orientation to all relevant users in the validated retweet network via a label propagation. the approach is similar, but different to the one proposed in [6] , the differences being in the starting labels, in the label propagation algorithm and in the network used. in this section we will revise the method employed in the present article, as compared it to the one in [6] and evaluate the deviations from other approaches. first step of our methodology is to extract the polarisation of verified users from the bipartite network, as described in section 5.1 of the main text, in order to use it as seed labels in the label propagation. in reference [6] , a measure of the "adherence" of the unverified users towards the various communities of verified users was used in order to infer their orientation, following the approach in [2] , in turn based on the polarisation index defined in [4] . this approach was extremely performing when practically all unverified users interact at least once with verified one, as in [2] . while still having good performances in a different dataset as the one studied in [6] , we observed isolated deviations: it was the case of users with frequent interactions with other unverified accounts of the same (political) orientation, randomly retweeting a different discursive community verified user. in this case, focusing just on the interaction with verified accounts, those nodes were assigned a wrong orientation. the labels for the polarisation of the unverified users defined [6] were subsequently used as seed labels in the label propagation. due to the possibility described above of assigning wrongly labels to unverified accounts, in the present paper, we consider only the tags of verified users, since they pass a strict validation procedure and are more stable. in order to compare the results obtained with the various approaches, we calculated the variation of information (vi, [17] ). v i considers exactly the different in information contents captured by two different partition, as consider by the shannon entropy. results are reported in the matrix in figure 2 for the 23th of february (results are similar for other days). even when using the weighted retweet network as "exact" result, the partition found by the label propagation of our approach has a little loss of information, comparable with the one of using an unweighted approach. indeed, the results found by the various community detection algorithms show little agreement with the label propagation ones. nevertheless, we still prefer the label propagation procedure, since the validated projection on the layer of verified users is theoretically sound and has a non trivial interpretation. the main result of this work quantifies the level of diffusion on twitter of news published by sources considered scarcely reputable. academy, governments, and news agencies are working hard to classify information sources according to criteria of credibility and transparency of published news. this is the case, for example, of newsguard, which we used for the tagging of the most frequent domains in the direct validated network obtained according to the methodology presented in the previous sections. as introduced in subsection 3.2 of the main text, the newsguard browser extension and mobile app [19] offers a reliability result for the most popular newspapers in the world, summarizing with a numerical score the level of credibility and journalistic transparency of the newspaper. with the same philosophy, but oriented towards us politics, the fact-checking site politifact.com reports with a 'truth meter' the degree of truthfulness of original claims made by politicians, candidates, their staffs, and, more, in general, protagonists of us politics. one of the eldest fact-checking websites dates back to 1994: snopes.com, in addition to political figures, is a fact-checker for hoaxes and urban legends. generally speaking, a fact-checking site has behind it a multitude of editors and journalists who, with a great deal of energy, manually check the reliability of a news, or of the publisher of that news, by evaluating criteria such as, e.g., the tendency to correct errors, the nature of the newspaper's finances, and if there is a clear differentiation between opinions and facts. thus, it is worth noting that recent attempts tried to automatically find articles worthy of being fact-checked. for example, work in [1] uses a supervised classifier, based on an ensemble of neural networks and support vector machines, to figure out which politicians' claims need to be debunked, and which have already been debunked. despite the tremendous effort of stakeholders to keep the fact-checking sites up to date and functioning, disinformation resists debunking due to a combination of factors. there are psychological aspects, like the quest for belonging to a community and getting reassuring answers, the adherence to one's viewpoint, a native reluctance to change opinion [28, 29] , the formation of echo chambers [10] , where people polarize their opinions as they are insulated from contrary perspectives: these are key factors for people to contribute to the success of disinformation spreading [7, 9] . moreover, researchers demonstrate how the spreading of false news is strategically supported by the massive and organized use of trolls and bots [25] . despite the need to educate the user to a conscious fruition of online information through means also different from those represented by technological solutions, there are a series of promising works that exploit classifiers based on machine learning or on deep learning to tag a news as credible or not. one interesting approach is based on the analysis of spreading patterns on social platforms. monti et al. recently provide a deep learning framework for detection of fake news cascades [18] . a ground truth is acquired by following the example by vosoughi et al. [27] collecting twitter cascades of verified false and true rumors. employing a novel deep learning paradigm for graph-based structures, cascades [19] https://www.newsguardtech.com/ are classified based on user profile, user activity, network and spreading, and content. the main result of the work is that 'a few hours of propagation are sufficient to distinguish false news from true news with high accuracy'. this result has been confirmed by other studies too. work in [30] , by zhao et al. examine diffusion cascades on weibo and twitter: focusing on topological properties, such as the number of hops from the source and the heterogeneity of the network, the authors demonstrate that networks in which fake news are diffused feature characteristics really different from those diffusing genuine information. diffusion networks investigation appear to be a definitive path to follow for fake news detection. this is also confirmed by pierri et al. 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italy supplementary material guido caldarelli 1,2,3* † , rocco de nicola 3 † , marinella petrocchi 4 † , manuel pratelli 3 † and fabio saracco 3 † there is another difference in the label propagation used here against the one in [6] : in the present paper we used the label propagation of [22] , while the one in [6] was quite home-made. as in reference [22] , the seed labels of [6] are fixed, i.e. are not allowed to change [17] . the main difference is that, in case of a draw, among the labels of the first neighbours, in [22] a tie is removed randomly, while in the algorithm of [6] the label is not assigned and goes into a new run, with the newly assigned labels. moreover, the updated of labels in [22] is asynchronous, while it is synchronous in [6] . we opted for the one in [22] for being actually a standard in the label propagation algorithms, being stable, more studied, and faster [18] . finally, differently from the procedure in [6] , we applied the label propagation not to the entire (undirected version of the) retweet network, but on the (undirected version of the) validated one. (the intent of choosing the undirected version is that in both case in which a generic account is significantly retweeting or being retweeted by another one, they do probably share some vision of the phenomena under analysis, thus we are not interested in the direction of the links, in this situation.) the rationale in using the validated network is to reduce the calculation time (due to the dimensions of the dataset), while obtaining an accurate result. while the previous differences from the procedure of [6] are dictated by conservativeness (the choice of the seed labels) or by the adherence to a standard (the choice of [22] ), this last one may be debatable: why choosing the validated network should return "better" results than the ones calculated on the entire retweet network? we consider the case of a single day (in order to reduce the calculation time) and studied 6 different approaches:1 a louvain community detection [5] on the undirected version of the validated network of retweets; 2 a louvain community detection on the undirected version of the unweighted retweet network; 3 a louvain community detection on the undirected version of the weighted retweet network, in which the weights are the number of retweets from user to user; 4 a label propagation a la raghavan et al. [22] on the directed validated network of retweets; 5 a label propagation a la raghavan et al. on the (unweighted) retweet network; 6 a label propagation a la raghavan et al. on the weighted retweet network, the weights being the number of retweets from user to user. actually, due to the order dependence of louvain [12] , we run several times the louvain algorithm after reshuffling the order of the nodes, taking the partition in communities that maximise the modularity. similarly, the label propagation of [22] has a certain level of randomness: we run it several times and choose the most frequent label assignment for every node. key: cord-022130-jckfzaf0 authors: walsh, patrick f. title: intelligence and stakeholders date: 2018-09-19 journal: intelligence, biosecurity and bioterrorism doi: 10.1057/978-1-137-51700-5_7 sha: doc_id: 22130 cord_uid: jckfzaf0 this chapter underscores the need for more explicit and strategic engagement of stakeholders (scientists, clinicians, first responders, amongst others) by the intelligence community. the chapter argues that the intelligence community will increasingly rely on their expertise to build more valid and reliable assessments of emerging bio-threats and risks. however, the discussion also identifies some of the limitations and challenges stakeholders themselves have to understanding complex threats and risks. agricultural scientists and veterinarians) can all be critical stakeholders for intelligence communities. without them it would be almost impossible to see how the ic alone can fulfil its mission to identify, prevent, disrupt and treat potential and emerging bio-threats and risks. indeed as seen in chapter 4 'the scientific community' brings a lot of expertise to the intelligence community about how to assess bio-threats and risks in a number of different ways and contexts. these include understanding potential risks through gof experiments, the development of biosensors and knowledge about weaponisation, pathogenicity and transmissibility of various bio-agents. chapter 4 also surveyed briefly the role of scientists working in epidemiology and forensics as providing central roles in the prevention, disruption and treatment of bio-threats and risks. additionally, chapter 5, highlighted the critical role the scientific community plays in helping the intelligence community better frame their understanding of potential threats and risks emerging from the fast paced changing biotechnology and synthetic biology sectors. this chapter provides a thematic analysis of how important stakeholders can contribute to reducing current and emerging bio-threats and risks. in contrast to chapter 6, which focused on what internally the intelligence community can do to better equip itself to manage bio-threats and risks, this chapter surveys what important external stakeholders can bring to the table to improve intelligence capability and to reduce bio-threats and risks themselves. paraphrasing research impact scholar mark reed's definition, i define a stakeholder of the intelligence community as any person, organisation or group that is affected by or can affect a decision, action or issue relevant to preventing, disrupting or treating bio-threats and risks (reed 2016: 41) . specifically, i am referring to stakeholders in the scientific, research, clinical, policy, first responder and private sectors that can provide capability, expertise to the intelligence community and/ or contribute to biosecurity through their own actions. in particular, the thematic analysis of the role of stakeholders in this chapter is organised around three sub-headings: prevention, disruption and treatment. traversing the literature and interviews with a select number of stakeholders shows there that there is a large and diverse number of individuals and organisations that could potentially play a role in either preventing, disrupting or treating future bio-threats and in the biological context, surveillance is the ongoing collection, analysis, and interpretation of data to help monitor for pathogens in plants, animals, and humans; food; and the environment. the general aim of surveillance is to help develop policy, guide mission priorities, and provide assurance of the prevention and control of disease. in recent years, as concerns about consequences of a catastrophic biological attack or emerging infectious diseases grew, the term bio surveillance became more common in relation to an array of threats to our national security. bio surveillance is concerned with two things: (1) reducing, as much as possible, the time it takes to recognize and characterize biological events with potentially catastrophic consequences and (2) providing situational awareness-that is, information that signals an event might be occurring, information about what those signals mean, and information about how events will likely unfold in the near future (gao 2011: 9). this definition highlights how the functions and roles of biosurveillance has changed from a more narrow concern of mapping disease in the public health sector to represent a diverse array of knowledge and capabilities that are vital in understanding bio-threats in the national security context. the definition also underscores the ongoing multiple challenges in improving bio-surveillance capabilities and their utility in the national security context. three key challenges in particular remain for improving national bio-surveillance capabilities and they are: methodological, information sharing and integration issues. the information sharing and integration issues have already been discussed in chapter 6 so this section will focus on the bio-surveillance methodology issues. by methodological issues, i am referring to both the technical methods (biosensors) and the broader different disciplinary approaches to biosurveillance that now inform debates amongst stakeholders on how to improve bio-surveillance capabilities. from a technical perspective, there has been a range of bio-sensor research from inside and outside the ic to detect the release of dangerous pathogens into the environment. perhaps the most well-known of these initiatives-biowatch was developed by dhs in 2003 with the aim to detect aerolised bio attacks for high risk bioagents in major us cities. the program however, has had mixed success relating to the reliability of results and the delay in the publication of these once samples were collected from the field (gao 2016 (gao , 2017 . the dhs tried to speed up the detection times from the first generation manual systems to gen 3 acquisitions, which promised speedier autonomous systems though testing difficulties remained. further analysis, however, of alternatives by the dhs as showing any advantages of an autonomous system over the current manual system were insufficient to justify the cost of a fully technology switch (gao 2016: 7) . in the us, research continues to improve the robustness, sensitivity, specificity, timeliness and cost of biosensor equipment. while conventional pcr based methods and immunoassay are still being used other biochemical, microbiological and genetic solutions are being trialled such as the incorporation of antibodies and peptide molecules, which may greatly reduce detection times to minutes instead of several hours (kim et al. 2015) . leaving aside efforts to improve aerolised biosensors, the expected rapid growth of synthetic biology and biotechnology and the potential (however unknown) that bioengineered material may be used maliciously in a way that threatens public safety or national security may shift the focus into other scientific research that can detect signals of bio-engineering including types of changes, location and possibly in the future where changes were made. in july 2017, iarpa commissioned a new program-finding engineering linked indicators (felix) to meet such objectives. iarpa is seeking interest from a range of scientists (synthetic biologists, micro biologist, immunologist, statisticians and computer scientists) to carry out 3-5 research projects addressing the two main focus points of felix (eaves 2017) . if this research can produce reliable results, it will provide another useful collection and analysis point for the ic by allowing the detection of previously undetectable signatures of bio-engineered material in bio-criminal and terrorism cases. in addition to the various technical innovations in biosensors, a range of other bio-surveillance methods have been deployed. in the late 1990s, the us cdc pioneered syndromic surveillance systems, which were initially aimed at improving the early warning of infectious diseases and bio-terrorism and have now evolved to include situational awareness (buehler et al. 2004) . similar syndromic surveillance systems have developed in other 'five eyes' countries such as the uk's real-time syndromic surveillance team (resst), which collects four national syndromic surveillance systems from several sources. additionally and more recently, the robert koch institute is creating an early warning system based on machine learning and natural language processing that will include 'appealing' interactive web applications and be linked to the german electronic reporting and information system demis (robert koch institute 2018). syndromic surveillance systems are a critical adjunct to traditional public health lab surveillance as they strive to provide real time or near real time collection, analysis and dissemination of health data to enable early identification and management of public health threats as they are not based on lab confirmed diagnoses-and assess a wider set of health related data including: clinical signs, absenteeism, pharmacy sales or animal health production collapse (buehler 2004) . a clear benefit of syndromic surveillance is it can be cheaper, faster and potentially more transparent then a state's public health lab surveillance system. however, as with the use of big volumes of data more broadly in the ic, data quantity, quality and structural variation all impact on the utility, accuracy and timeliness of some rapid epidemic intelligence from internet based surveillance methods (yan et al. 2017) . increasingly these syndromic surveillance systems rely on the use of big data, machine learning and analytics. additionally, web based epidemic detection systems like biocaster portal developed by the national institute of informatics in tokyo (collier 2015) and canada's global public health intelligence network (gphin) an event based surveillance system which looks at news feeds globally have also contributed to syndromic surveillance systems (mawudeku et al. 2015) . several event based internet surveillance systems have grown in number in the last decade. using pubmed, scopus and google scholar data bases, o'shea's study found 50 based internet systems all using different technology and data sources to gather data, process and disseminate it to detect infectious disease outbreaks (o'shea 2017). in line with the broader ic development of exploiting social media analytics discussed in chapter 4, in 2013 dhs piloted another approach to bio-surveillance. the pilot involved dhs trialling various social media analytics from self-reported information on facebook and twitter to determine pandemics and acts of terrorism given social media feeds can provide close to real time reporting of symptoms, sickness access to hospital or pharmaceuticals (insinna 2013) . additionally, other private companies have entered the biosurveillance space-providing novel methods for capturing bio-surveillance data. wilson's discussion of how a private company (veratect corporation) assessed signal recognition in global media reports to provide warning on the emergence of the 2009 h1n1 influenza pandemic shows how the ic warning culture methodology can be employed usefully along with what he described as the 'risk adverse forensically oriented response culture favoured by traditional public health practitioners' (wilson 2017: 1) . the veratect case shows that the private sector has a role in developing better bio-surveillance capability as well. as can be seen from the brief discussion above about different methodological approaches to bio-surveillance. there are also different views amongst bio-surveillance scholars and practitioners about the merits of each, particularly in their abilities to predict the 'next pandemic'. can for example, a national bio-surveillance system informed by one or more methods discussed above predict the emergence of the next pandemic or outbreak, particularly novel new viruses? some scientists argue that the prediction of a micro-evolutionary process of some biological agents such as a virus (i.e. a short term emergence or cross species transition) is incredibly difficult given evolutionary and epidemiological timescales are fundamentally different. geoghegan and holmes argue that instead it would be better to build surveillance capability that 'assesses the fault line of disease emergence at the human-animal interface, particularly those shaped by ecological disturbances' (2017: 7). others have argued differently. scientists working on the usaid funded predict and the global virome project examine disease hotspots globally in order to sequence (rather ambitiously) almost all the viruses in birds and mammals that could potentially spill over into humans. in particular, researchers working on the global virome project believe that prediction of which viruses might spill over from animal to human health is possible. geoghegan and holmes in response argue focusing on disease hotspots relies on very small amounts of data that can be unreliable given they are rare events. they give the example of saudi arabia which has not classically been a hotspot, yet mers recently jumped into humans from camels there. sequencing these viruses may provide useful evolutionary information, but geoghegan and holmes argue it won't necessarily provide early warning of what is going to affect us (geoghegan and holmes 2017) . other scientists are trying to change the ecology of disease, which presumably in some cases would make the early warning of some pandemics easier. in recent years, the scientific community has increasingly exploited crispr gene editing techniques to change the genetic makeup of malaria mosquitoes. additionally, advances in gene drives have recently been shown to change the ecological parameters of disease. gene drives are artificial 'selfish' genes that can force itself into 99% of an organism's offspring instead of the usual 50%. currently there is a global research effort funded by the gates foundation to cause female mosquitoes to become sterile within 11 generations or 1 year. the objective would be to release the genetically altered mosquitoes into malarial areas by 2029 (regalado 2016) . there are concerns by the fbi however that gene drives could be misused to create a 'designer plague' (ibid.). in addition to the 'predictability' challenges presented by various bio-surveillance methods, there are also differences in opinion amongst members of the bio-surveillance community about what an effective bio-surveillance system looks like. on what metrics can an 'effective bio-surveillance' system be evaluated given the multiple methodological approaches and systems that have developed for bio-surveillance? clinician and public health security specialist jim wilson has argued that the development of an effective global surveillance and response system is probably at least a decade or more away (wilson 2017: 222) . in the interim, we are left with multiple approaches of varying validity and reliability. so based on the current fragmented bio-surveillance efforts how do we learn the lessons that need to be learnt that will enable the implementation of the long awaited national bio-surveillance capabilities? how do we know if progress is being made to that goal? importantly, beyond national efforts, how do we assess the current capability of state, local agencies to contribute to a national bio-surveillance capabilities? where are the gaps and vulnerabilities in the current sub-national bio-surveillance and detection systems? (gao 2011) . compounding the current challenge of evaluating bio-surveillance capabilities in order to construct a viable national approach is that different bio-surveillance systems have been created for different end users (e.g. animal and human). the blue ribbon project report into animal health detailed information sharing challenges in animal health bio-surveillance and its integration with other bio-surveillance data including in human health (blue ribbon report 2017: 25) . this lack of integration makes it difficult to assess how information collected for animal or agricultural bio-surveillance could improve national approaches to bio-surveillance, particularly in scenarios where the emergence of disease could be an intentional or a malevolent act. different approaches to bio-surveillance have been informed by multi-disciplinary perspectives, which can be both a strength and weakness to developing a national perspective. current efforts across the 'five eyes' to develop fully national and integrated bio-surveillance capabilities remain works in progress and the political will to steward them into being seems insufficient. for example, in the us a program designed to provide a national bio-surveillance and integration system was eliminated in the president's budget request for fy 2018 (blue ribbon report 2017: 41). any evaluation of the effectiveness of various methods and approaches for building a national bio-surveillance capability also needs to consider how national efforts can both enhance and lever off global bio-surveillance capabilities. gaps and impediments in global biosurveillance have become increasingly evident to the world in the wake of the largest ebola epidemic ever-in which these challenges impacted the ability to prevent, detect, and respond. under the looming threat of mers-cov, leishmaniasis, influenza, multidrug-resistant tuberculosis, and plague, the global public health community now realizes the urgent need to address shortcomings in global bio-surveillance and the broader public health security system. properly preparing for the next major outbreak hinges on our willingness to transform global health surveillance systems and those of countries with fragile health infrastructures (shaikh et al. 2015: 183-186) . in some respects, similar challenges in developing national bio-surveillance capabilities exist in those at the global level including: siloed systems, inadequate training and technical expertise, different information and communication technology (ict) standards, concerns over data sharing and confidentiality, poor interoperability, and inadequate analytical approaches and tools. there is likely not one bio-surveillance method, technique or tool that is going to detect in real time disease outbreaks, particularly unusual ones which might imply malicious intent. a fully integrated approach to bio-surveillance may rely on more than one method or capability which together can provide reliable and valid bio-surveillance data and early warning at the national and global level. it may mean investigating ways that older legacy systems can be integrated or at least made interoperable with newer more mobile platforms such as mobile or wireless health technologies particularly in the developing world (shaikh et al. 2015) . it should be clear by now that improving bio-surveillance capabilities is essential to improving the prevention of natural and suspicious outbreaks of disease. it is important for the 'five eyes' intelligence and law enforcement communities to understand broadly the theoretical and practical developments in bio-surveillance so that they are able to more effectively lever relevant knowledge on bio-threats and risks. a second cluster of stakeholders that are useful in the prevention of bio-threats and risks (both natural and malicious) are those working in national, regional and global health. the ebola epidemic (2014) (2015) was a recent reminder of the consequences of weak public health capability and infrastructure in failing to prevent, identify and respond quickly to infectious disease. the ebola epidemic also had a catalytic effect on many public health authorities, practitioners and researcher's views about the capability of the traditional un response to global health crisis mainly coordinated through the who. many public health watchers are now arguing the need for a broader more effective focus-not just on prevention and response to infectious disease, but one that also included reframing the focus as a human security issue. adherents to this view make a compelling point when seen through the ebola case that continues to have significant impact on the economic and social stability of countries impacted (sparrow 2016; marston et al. 2017; who 2015; mmwr 2016) . beyond west africa, similar vulnerabilities in capabilities such as diseases surveillance, detection, contract tracing, clinical care, community engagement and communications exist globally as was also seen with the proliferation of zika in latin american/caribbean and mers in the middle east. in 2016, the commission on a global health risk framework for the future that met after the ebola crisis estimated 4.5 billion per year investment would be needed for better detection and response tools. the same commission report also estimated that the economic cost for global pandemics per year was $60 billion (schnirring 2016; dzau and sands 2016) . effective national bio-surveillance relies on not only what 'five eyes' countries can do to improve the scientific and technical capability of bio-surveillance, but also how they can improve bio-surveillance globally particularly in at risk areas. beyond effective bio-surveillance, effective prevention of pandemics whether natural, accidental or malicious relies on good global (multilateral), regional and national public health responses. there are several multilateral instruments, institutions and initiatives that are relevant, but i will focus here on what have become the key ones rather than attempting to traverse in detail all major international health initiatives struck since 9/11. they include who international health regulations (ihr), un security resolution 1540, the global health security agenda (ghsa), the biological weapons convention (bwc) and the australia group. the who international health regulations (2005) entered into force in june 2007 to prevent, protect against, control and provide a public health response to the international spread of diseases (detect, assess, notify events has a biosafety and biosecurity function) and includes all 192 members of the un. the ihr 2005 has improved accountability of countries about progress towards building national core public health capability targets in several areas including, but not limited to: surveillance systems, creating rapid response teams, border management. however, the ihr annual reporting process has been by self-assessment of core capacities to the world health assembly (wha) by all state parties, which has resulted in incomplete or not credible reporting for some member states. the commission on global health risk framework for the future also expressed concerns over the self-assessment monitoring tool of the ihr, because questions are binary (yes/no) answers and recommended that who devise a regular independent mechanism to evaluate country performance against benchmarks (ghrf commission 2015: 33). for example, a country can 'tick yes' for having a national public health legislation, but other dependent legislation (biosecurity, food safety, environmental health) may not be in place-thereby reducing overall the country's ability to manage health crisis or for the global community to understand and respond to capability and information gaps in that country (ibid.). some countries continue to be slow or uneven in their reporting of ihr (2005) attributes. in 2013, one study showed that the african region was well below global averages across all attributes measures with no african state reporting full implementation (kasolo et al. 2013: 11-13) . the second multilateral instrument relevant to our discussion here is the un security council resolution 1540 (2004 , which calls on all 192 states to prohibit non-state actors from developing, acquiring, manufacturing, possessing, transporting, transferring or using nuclear, chemical or biological weapons and their delivery systems. more importantly and specific to bio-threats only, the bwc has historically played the most significant role in preventing the weaponisation of biology. the bwc was established in 1972 and seeks to prohibit the development, production, acquisition, transfer, stockpiling and use of biological and toxin weapons (gerstein 2013; chevrier and spelling 2016: 331-356) . in 2001, there was an attempt by some member states to introduce a verification process, but this was vetoed by the us following inspection of soviet sites under the tripartite agreement between the soviet union, usa and the uk. the us arguing it could be difficult to certify that a state's biological program was merely defensive rather than offensive. the us also had concerns that inspection to labs could be disruptive or provide opportunity for industrial espionage against legitimately operating biotechnology companies (gerstein 2013: 137) . historically there has been a mixed record by some 'five eyes' intelligence countries in assessing verification and therefore noncompliance of the bwc. koblentz surveyed the role of intelligence (particularly humint) in assessing the former soviet union's offensive bio-weapons program between 1971 and 1990 which resulted in an incomplete picture of moscow's program (koblentz 2009: 157) . additionally, as discussed in chapter 2, in 2002 several 'five eyes' intelligence communities (us, uk and australia) incorrectly assessed that iraq had a mobile offensive bio-weapon capability. intelligence collection on its own can either over or under-estimate such capabilities. between 5 yearly review conferences, several initiatives and activities have been introduced (confidence building measure, meetings of experts, information exchanges) to improve the effectiveness and the implementation of the convention. however, state parties are only encouraged to implement relevant national legislation and other measures to prohibit prevent the development, production, stockpiling or transfer or use of bio weapons. how they precisely undertake measures is at the discretion of individual state parties. the bwc has been criticised for several reasons over the years. some of this is warranted, while other criticisms seem to not take into account that the bwc is different from its chemical and nuclear counter proliferation counterparts. as gerstein argues, 'material is the centre of gravity for nuclear discussions and intent being the center of gravity for biological issues' (gerstein 2013: 176) . developing nuclear weapons leaves a large recognizable footprint, whereas the development of an offensive biological weapon requires virtually no specialised equipment (ibid.). the first major criticism of the bwc is that it has no verification mechanism or any other mandatory provisions for monitoring compliance. a second complaint is that for many years (until 2006) , it lacked an implementation capability to help states fulfil their obligations. since 2006, the convention has had a small three team implementation support unit (isu) based in the united nations office for disarmament affairs in geneva which aims to 'assist, coordinate, and magnify the implementation efforts of the states parties to help states parties help themselves' (lennane 2011: 85) . in reality though, the isu does not have 'capacity for analysis and coordination other than for the collection of the annually submitted confidence building measures, posting them to the website and organising and attending conferences' (gerstein 2013: 173) . historically there has also been a low number of party states submitting their annual confidence building measures. although the bwc isu was able to report that a record number (81) annual confidence building measures were submitted in 2016, this only represented 45.5% of all 179 state parties submitting that year. though the trend line seems to be going up from a low in 2014 of 19 (bwc newsletter 2017: 3). a third criticism of the bwc is that it has moved slowly since inception and further questions remain about its relevance strategically and operationally in preventing bio-threats and risks into the future. such questions are likely fundamental to its long term viability. however despite shortcomings, the bwc has nonetheless created a normative institution for reducing the risk of biological or toxin weapons being used or developed by state and non-state actors (lennane 2011: 85) . more importantly, as developments in biotechnology continue at a pace, the bwc does provide a venue, where the security implications of dual-use technology can be assessed which will be critical in 'mitigating these emerging threats' (gerstein 2013: 175) . the bwc still does have an important role in reducing weaponisation of biology in the future, though its poor funding particularly of the isu means that other multi-lateral measures are needed to amplify the work of the convention. in addition to the above historic/traditional proliferation arrangements of the bwc, other international regimes have been implemented such as the australia group (established in 1985) and the proliferation security initiative (established in 2003). both have a broader counter proliferation objectives beyond biological weapons to chemical and nuclear. the australia group 41 member countries have collaborated on the development of lists of technologies and materials that could be used in the development of chemical and biological weapons. member countries then commit to monitor the export or transfer of these materials. the australia group maintains common control lists for dual use bio-equipment, technology, software, bio agents and plant and animal pathogens as the basis for promoting common standards and regulations (australia group common control list handbook 2015). the australia group works in concert with the bwc. the psi was a bush administration initiative that sought to supplement existing non-proliferation regimes, but seeks to enforce these by interdicting and seizing illegal weapons or missile technology in planes or ships carrying cargo. the psi also includes intelligence sharing and joint operational activity (national institute for public policy 2009). turning the focus slightly away from multi-lateral counter proliferation measures, other multilateral initiatives have focused on improving global health security. in some respects the ghsa provides a bridge between traditional, narrow security approaches to biological weapons and a wider securitisation of global health. the ghsa was established in 2014 by the obama administration and is a multi-sectoral approach to global health security seeking to include governments, international organisations and non-government organisations. ghsa was set up in part to 'advance further the ihr implementation through focused activities to strengthen core capacities and to ensure a world safe and secure from global health threats posed by infectious disease; where we can prevent or mitigate the impact of naturally occurring outbreak and intentional or accidental releases of dangerous pathogens' (heymann et al. 2015 (heymann et al. : 1889 . ghsa is a refreshing approach not only because it seeks to establish a global framework and capacity to assess, measure and sustain advances in global preparedness for epidemic threats, but it also addresses biosecurity as a public health priority-thereby linking public health and health security, development, defense and agricultural sector (cameron 2017) . the underlining logic of ghsa suggests that the same attributes needed to prevent, detect and respond to deliberate use of a bio agent are those required to manage a natural or accidental outbreak of a biological agent. ghsa also includes 12 technical targets aligned to three areas: prevention, detection and response (heymann et al. 2015 (heymann et al. : 1889 . like earlier initiatives, such as the us sponsored global health initiative (ghi), which was discontinued by the obama administration in 2012 due a lack of financial and technical authority to leverage and coordinate multiple us agencies-the ghsa will need to secure ongoing funding beyond 2019 from major donors including the us. at a november 2017 ghsa ministerial meeting in uganda, assembled governments signed onto an extension of the ghsa for another five years. us secretary tillerson had issued public support for continuing it, but at the time of writing no commitment by the us for future financial support (beyond fy 2019) has been made. ghsa holds promise, but in addition to ongoing funding challenges, those member states signed up to it will need to ensure effective governance is in place to align funding to global health priorities articulated by the who, world bank, imf and other donors in order to avoid duplication and promote an effective approach to international health security capabilities (paranjape and franz 2015; . in summary, this discussion of multilateral security and global health initiatives demonstrates that there is a diverse number of stakeholders working in these sectors, which can play a role in preventing biothreats and risks-whether they are natural pandemics or a malicious attack from a biological weapon. it's clear that the 'five eyes' intelligence communities have worked extensively with other member states in counter-proliferation institutions such as the bwc and the australia group for several decades, but what remains still under developed is how global health security stakeholders and intelligence communities can work more collaboratively for the mutual goal of global health security regardless of whether the risks are natural pandemics or result from a bio-terror attack or theft of a dangerous select agent from a lab. more trusting and formalised contact between both global health security stakeholders and those working in the security and intelligence communities can only be mutually beneficial to preventing major bio-threats and risks. the final cluster of stakeholders that can help prevent bio-threats and risks are of course those that specialise in biosafety and its promotion in their research institutes, biotechnology companies, universities and medical facilities. promoting biosafety in environments that work with select agents and other facilities that work with less dangerous material which can still cause harm relies on consistently high risk management practices. in all 'five eyes' countries there has historically been in place biosafety risk management procedures and practices to prevent accidental infection, accidental release, or intentional misuse of biological substances. however, as noted in chapter 2 in the last two decades the expansion in synthetic biology, biotechnology and biological science research has meant there are now more people working in more locations on dangerous pathogens-not just in well-regulated liberal democracies such as those in the 'five eyes' countries, but also in developing countries; where biosafety and biosecurity capabilities and practice may be less established such as parts of africa, the middle east, pakistan and former soviet states (gronvall et al. 2016; shinwari et al. 2014) . just in terms of the scale of this expansion of facilities working with dangerous pathogens-in the us alone, there is thought to be thousands of bsl 3 labs and in china the number of such labs is increasing too (nature editorial 2014: 443). the us and other 'five eyes' countries such as canada have invested in cooperative engagement programs since 9/11 in several former soviet union states. the us defense threat reduction agency (dtra) has lead efforts in georgia to reduce bio-risk by securing/consolidating pathogens, training scientists in biosafety and biosecurity technology, regulation and detection. likewise, the cdc has been involved in building public health capacity there as well as in armenia and azerbaijan (bakanidze et al. 2010: 7) . as important as building biosafety capacity is in developing countries, it is clear that much more still needs to be done to build biosafety capacity in 'five eyes' countries-including finding better ways to understand and manage comprehensively threats and risks in the biosciences environment. biosafety experts such as salerno and gaudioso argue for more comprehensive risk management systems across the global bioscience community 'to avoid an accident that jeopardizes the entire bioscience enterprise' (salerno and gaudioso 2015: xv) . their argument is that such a system would supplement existing national and international biosafety regulations by risk managing fully at an organisational and unit level every single potential incident rather than by generic risk hazard assessments that are currently done by most facilities today (ibid.: 201). others have also called for more systematic tools and approaches for managing biosafety incidents in labs dealing with particular dangerous pathogens such as marburg virus (dickmann et al. 2015) . still others have argued that while 'security awareness is high among employees who work with biological select agents and toxins, it is not pervasive across the entire life research community' (grphyon scientific 2016 : 1014 . such a statement does not seem to be hyperbole if one looks at some of the cases of biosafety and security lapses since 9/11 (gao 2009 (gao , 2013 . there have been several lapses at cdc between 2014 and 2016. in june 2014, dozens of workers in cdc could have been potentially exposed to live anthrax that hadn't been killed before being shipped from cdc's bioterrorism rapid response and advanced technology (brrat) bsl 3 to a bsl 2 lab in its bacterial special pathogens branch. cdc investigations determined that at least 67 cdc staff members may have been exposed to viable anthrax cells or spores though no illness or deaths occurred (cdc 2014). the same report found several breaches of biosafety process and procedure including failures of policy, training, supervision, judgement and even scientific knowledge (ibid.). similarly, biosafety lapses cases involving cdc labs occurred in january 2014 when an unintentional cross contamination strain of low pathogenic avian influenza a (h9n2) with a strain of highly pathogenic avian influenza a (h5n1) was shipped from cdc to the usda (schnirring 2014) . further biosafety breaches were detected in july 2014-this time at the national institute of health campus in bethesda maryland; where 6 viable smallpox vials were discovered improperly stored (dennis and sun 2014a ). an additional five improperly stored vials were also found at the nih-three were select agents (burkholderia pseudmomallei, francisella tularensis and yersinia pestis ) (dennis and sun 2014b). in the nih cases despite their age, they were still viable organisms which could have caused illness. their theft could have also posed a bio-threat and risk to the community. then after a hiatus where biological material was suspended being sent between bsl 3 and bsl 2 labs live transfers commenced again. after a further internal cdc review (cdc 2015a, b) some additional safety measures were put into place, however there was a subsequent lapse when a specimen of chikungunya virus was shipped from a high secure lab in fort collins to a lower level one which had not been killed (young 2015) . similarly, in 2015 the pentagon shipped live anthrax spores from the dugway proving ground in utah to 9 states and one international location that were also meant to have been killed (burns 2015) . it was later found that dugway and the us dod had been shipping nationally and internationally live anthrax for more than 10 years-often without adequate safeguards. other reports suggested that some samples were sent by federal express (sisk 2016) . similarly in november 2016, the us hhs discovered that a private lab had 'inadvertently sent a toxic form of ricin to one of its training centres multiple times since 2011 putting training staff at risk' (gao 2017: 1). similar biosafety lapses have occurred in the uk resulting in 75 investigations since 2010 of government, university and hospital labs (sample 2014) . as noted in chapter 2, one possible bio-threat and risk pathway could be the theft of biological substances or information from a biosciences institution. lapses in biosafety arrangements demonstrate, at least in some cases, biosecurity vulnerabilities that could make the theft or even infiltration of a threat actor into high containment lab easier. thefts from labs have occurred in the past by an insider, and a motivated insider can compromise biosafety for a range of reasons. bunn and sagan's edited book insider threats provides a useful taxonomy for thinking about 'insider threats' (bunn and sagan 2016). they can be: self-motivated insiders, who at some point decide to become a spy or thief. insiders can also be recruited insiders, who are already inside an organisation, but become convinced to become part of a plot. finally, an infiltrated insider might be associated with some adversary of the organisation and join it with the purpose of carrying out a malicious act against it. bunn and sagan also refer to inadvertent or non-malicious actors, who pose a threat by making mistakes without really intending to do so-such as leaving a password lying around. finally, the authors refer to a 'coerced insider', who remains loyal in intent, but knowingly assists in theft or sabotage to prevent hostile acts against themselves or their loved ones (ibid.: 4). the insider threat that was posed by bruce ivins' activities in a high containment lab (that resulted in amerithrax in 2001) demonstrates the potentially high threat and risks associated with an insider. the ivins case provides a useful case study in how an organisation's security procedures and other organisational and cognitive biases can miss for several years risks posed by an insider threat actor (stern and schouten 2016: 74-102) . since the amerithrax incident, significant investment has been made to close the biosafety vulnerabilities revealed by it. increasingly since 9/11 and amerithrax, a number of policies, procedures and normative behaviour have developed in the scientific community to promote biosafety and biosecurity. these have ranged from safety regulation codes such as the us biosafety in microbiological and biomedical laboratories (bmbl ) to more formal legislative and oversight regulations. the latter will be addressed in chapter 8. there are also technical and policy improvements that can be made in securing both physical and remote access to labs including computer systems that house data, which are at risk of theft or being hacked (gryphon scientific 2016 : 1014 berger 2013: 113-127; slayton et al. 2013: 51-70) . leaving aside discussion of some of the formal legislative and regulatory instruments for promoting biosafety, the development and maintenance of effective risk management across the biosciences also relies on an organisational culture that treats biosafety and biosafety as an equal priority to other deliverables. a culture of accountability at all levels must also exist if effective risk management can prevent, identify and treat bio-threats and risks promptly. a rogue insider threat, who may have been assessed as appropriate to work with select agents and seems initially to follow all the relevant biosafety regulations and procedures could still pose a risk if they have not embraced the organisation's normative cultural biosafety values. it is critical then in order to stop opportunities for insider threats, that the organisation promote relevant biosafety cultural values as much as and perhaps more than adherence to formal biosafety regulations. risk management measures must of course be measured against the ability of scientists to carry out its functions. effective engagement with local law enforcement and relevant domestic security intelligence organisations in each 'five eyes' country to help scientists build viable biosafety cultures will likely remain important in addition to internal organisation biosafety initiatives. stern and schouten provide a number of useful suggestions for improving policies and procedures that may help improve biosafety cultures across the biosciences enterprise (2016: 101-102). two that i think would be helpful are, one: developing standard operating procedures for proactively identifying vulnerabilities including using 'red team' exercises to explore how systems could become exploited. in other words, what motivators (financial, psychological, religious, and political) might drive an insider threat and are there ways to assess the signs of such an evolving threat? the other is to 'ensure personnel reliability programs incorporate ongoing assessments of counterintelligence vulnerabilities, including vulnerabilities to self-ascribed whistle-blowers or attention seekers' (ibid.: 101). effective biosafety and biosecurity training is also crucial as the number of labs working with select agents or other dual use bio-agents proliferate globally, particularly in locations with fragile states. more consistent approaches to training will also be important so nations can be confident that as many scientists as possible regardless of the country or the context in which they work understand what bio-risks and threats may emerge and how to prevent or mitigate against them (sture et al. 2012 ). as discussed above there are multiple stakeholders in the scientific community, global health security and biosafety fields that can play a critical role themselves in preventing bio-threats and risks as well as supporting the operational efforts of the intelligence community to prevent these. while prevention of bio-threats and risks is one critical dimension that stakeholders can play central roles another is disruption. although the intelligence community can use a range of knowledge, technologies and methodologies from stakeholders in the scientific community, to prevent bio-threats and risks, we have to accept that it will not be possible to detect every criminal or terrorist act. nonetheless, some of the techniques, practices, technologies and knowledge available from stakeholders in the scientific community will still be useful to disrupting bio-threats and risks. in other words prevention may not always be possible yet measures can be put into placewhich can detect threats early enough to reduce their impact. similar to preventing bio-threats and risks, disrupting them will also rely on seeking advice from stakeholders involved in bio-surveillance, public health and biosafety research, amongst others on disrupting them as well. for example, as discussed earlier iarpa's commissioning of research into detecting signals of bioengineering changes (felix) may result in better capability for the intelligence community in not only preventing bioengineering changes that make it easier for terrorists to carry out attacks on populations, critical infrastructure or biotechnology companies, it could also help detect and disrupt the planning stages for such attacks. additionally as noted earlier, if a high containment lab has a strong biosafety culture it is more likely that disruption of a biothreat may be possible just by colleagues speaking up about suspicious activities in their working environment rather than any elaborate disruption knowledge and techniques, procedures the intelligence community might have in place to disrupt such threats. but knowledge, technologies, techniques and practice for disruption of bio-threats and risks cannot just come from scientific stakeholders in the biosciences, it should also come from other fields and practitioners working in other areas where successful disruption operations has taken place. these areas include criminology, policing, engineering, legislation, cyber, counter-intelligence amongst others. in this section, we examine briefly what other stakeholders and discipline perspectives might the intelligence community learn from that can provide better capabilities for the disruption of bio-threats and risks. are there lessons to be learnt from other stakeholders, disciplines or even other threat contexts that might be relevant to disrupting biothreats that might not have been initially detected? since 9/11, there are three stakeholder and discipline groups, which are investigating and applying disruption strategies to threats and risks and their knowledge might be relevant in disrupting threats and risks in the bio context. these are criminology, counter-terrorism and cyber. we will explore each briefly to see how stakeholders (researchers and practitioners) have developed disruption strategies in each and how they might be employed against bio-threats and risks. insights from criminology and the practical application of disruption for crime prevention has provided a supplementary approach to traditional law enforcement approaches of prosecution against certain crimes through the courts. disruption is not a new concept in criminology and law enforcement practice, though it can be difficult to define in all law enforcement contexts (ratcliffe 2008: 204) . its meaning at least in the criminology/policing/law enforcement contexts can partly be traced back to broader desires-initially by uk law enforcement followed later by other 'five eyes' countries in the late 1990s and early 2000s to move law enforcement away from its traditional reactive mode to offending to one driven by intelligence. this concept of law enforcement or policing being intelligence driven or led gained significant traction in the criminology and policing literature (walsh 2011; ratcliffe 2016; innes and sheptycki 2004) . it was driven initially in the uk by the desire for governments to maximise efficiencies and reducing costs by increasing the use of intelligence to drive strategic and operational decision-making. the implementation of intelligence led policing models into operational policing across 'five eyes' countries has had mixed results partly due to cultural, financial and leadership issues in agencies that have attempted to put intelligence at the centre of strategic and operational decision making in policing (walsh 2011; ratcliffe 2016) . nonetheless, despite historical challenges in adopting intelligence led approaches, increasing fiscal constraints and the ever increasing demands on law enforcement in managing both high volume crimes and complex operating environments in counter-terrorism, cyber and organised crime meant, at least in many national law enforcement agencies; a greater demand for an intelligence driven approach (walsh 2011) . this intelligence driven approach, which promulgated proactive disruption of crime strategies was in part an admission that not all crime could be prevented or the offenders prosecuted. additionally, in many law enforcement agencies such as the australian federal police (afp), the growing volumes of information collected have given intelligence a more central role in triaging the significance of information, value adding to it and guiding investigators to targets and operations that are high priority; or have the greater likelihood of successful prosecution outcomes. in complex organised crime cases such as transnational drug trafficking, people smuggling and even terrorism and cyber threats, which we discuss shortly-intelligence driven disruption strategies have become increasingly popular for many 'five eyes' law enforcement agencies. this has particularly been the case where it can be difficult to dismantle completely the organised crime group-or to even know the full extent of the group's network. disruption operations that attempt to take down threat actors with key roles (e.g. facilitator, financier, and logistics) may nonetheless reduce the threat posed by the organised crime network even if the network continues to exist. additionally, with some organised crime networks, it may be difficult to secure sufficient evidence for prosecution against a more serious offence such as drug importation, but there may be sufficient intelligence that can be used to make the criminal environment more hostile for the group's illicit enterprise by arresting key group members for lesser offenses such as unexplained wealth or migration irregularities. while disruption of crime does seem like a useful tool in preventing or reducing the impact of offenders, the criminology literature demonstrates it has been difficult to evaluate the effectiveness of intelligence driven disruption strategies. ratcliffe cited an rcmp disruption attributes tool, which attempts to examine where the disruption activity is aimed at (core business, financial, personnel) and whether the kind of disruption for one or more of these attributes is high, medium or low in impact (ratcliffe 2008: 207) . however, such tools are largely subjective and qualitative-making it difficult to accurately measure the impact of intelligence driven disruption measures. the other concern about disruption strategies is that they may just cause displacement, where other criminal enterprises take the place of those removed by law enforcement or as innes suggest, 'disrupting a network may just provide a vacuum for more dangerous offenders to step in' (innes and sheptycki 2004: 14) . finally, the literature suggest that employing effective disruption strategies rely on proactive collection and valid analysis that can led to both timely strategic and operational outcomes that in turn result in threat mitigation and harm minimisation. so are there benefits for the intelligence community working on bio-threats and risks to investigating research and practice for disrupting threats in the organised crime context? the answer is a qualified 'yes'. much of course depends on the nature of the threat and risk posed. clearly as with any crime, it is hard to disrupt a bio-threat, when it's still in the head of the offender. however, we do know that criminal and terrorist acts don't just happen spontaneously. there usually involve predicate steps taken by the offender. some of these might happen in very compressed periods while in other offences planning may take years. either way, and regardless of whether these can be detected by the intelligence community, there is likely to be some signs in the predicate planning stages of an impending threat/risk that can provide the intelligence community opportunities for disruption. it is difficult to say in which bio-threat cases disruption strategies will be most successful. much will depend on how quickly the intelligence community can collect and analyse information that may be indicative of an evolving bio-threat and risk. as discussed previously, good collection and analysis is contingent on having robust core intelligence processes in place and more importantly effective intelligence governance. both are needed to ensure intelligence efforts are coordinated across multiple internal intelligence community stakeholders, with relevant knowledge-as well as ensuring information and expertise from external stakeholders (the scientific community) is available to provide earlier warning signs of an emerging bio-threat. while it is important not to over-play the potential for success of the kind of disruption strategies used against traditional organised crime groups, there are likely bio-threat scenarios where disruption strategies may make a difference. arguably, disruption of bio-threats could be on a continuum with the individual threat actor on one end and a sophisticated organised group on the other. at the individual level one could have the scenario of a lone terrorist actor or a mad/bad scientist. while it may seem difficult to get early warning of the malicious act of mad/bad scientist, we saw in the earlier discussion on 'insider threats' that it may be possible to disrupt their activity before you reach an amerithrax style attack. twenty/twenty is hindsight with the bruce ivins amerithrax case, but the lessons learnt from this incident do provide guidance on the sources of collection and analysis required from within the intelligence and scientific communities to aid the disruption of this kind of bio-threat. it does not mean that all similar cases of 'insider threats' will be detected, prevented or disrupted, but a more careful collection and analysis of 'odd' behaviour or unusual security lapses by a scientist working in a high containment lab could reveal areas of vulnerabilities. detection both of abnormal changes to an individual's psychological profile and/or in their working environment can provide opportunities for those vulnerabilities to be disrupted. at the other end of the bio-threat scale, a more organised bio-criminal or terrorist planned event may resemble in some respects other illicit criminal markets and networks (drugs, identity fraud, money laundering) and thereby present opportunities for disruption. again this is not to suggest that disruption of organised bio-threat scenarios will be always be possible. as discussed in earlier chapters, since 9/11, even with state based wmd programs the intelligence community has had a mixed record in detecting them and uncovering the intention and capability of non-state actors to exploit dual use technology for malicious end remains difficult. however, disruption could be useful in some bio-crimes where there is a bigger network of actors involved in the illicit business. for example, in crime scenarios where food suppliers are not registered legally to import food into a 'five eyes' country because it poses a biosecurity risk, there may be opportunities for parts of the intelligence community (particularly national law enforcement agencies) to work with agriculture, animal health, food regulatory agencies and relevant scientific stakeholders to disrupt illicit food suppliers from a country of concern. equally there may be opportunities for disruption of activity from non-compliant biotechnology providers in a 'five eyes' country, who provide dual use equipment to a company overseas with a questionable profile that resides in a country vulnerable for terrorist infiltration. in addition to useful knowledge that can be gained from criminology and law enforcement practice there are also perspectives on disruption from contemporary counter terrorism studies that may have utility in the bio-threat and risk context. as noted above, since 9/11 law enforcement agencies across the 'five eyes' countries have been increasingly deploying disruption strategies in countering terrorism given the preservation of life demands an earlier interception of attacks preferably at the planning stage. as innes suggest in the case of counter terrorism operations, one aim is to overtly disrupt planned attacks, which has many effects including sending a message to other terrorist groups that they may be next, reassuring the community and if possible deploying countering violent extremism (cve) strategies in communities where future attacks may arise (innes et al. 2017: 253) . in the uk in particular, a key plank in its counter terrorism strategy has been disruption both at the strategic and tactical level. at the strategic level, disruption has involved a number of initiatives from arresting persons of interest, legislative action and enhanced surveillance (innes et al. 2017: 265) . in addition to global influence of groups such as al qaeda and islamic state, the growth in lone actor attacks-some 198 across the us and european countries from 1970s to late 2000s (danzell and montanez 2016: 136) has also been a significant catalyst for enacting further stringent legislative measures such as detention without trial and control orders (walsh 2016 ). all 'five eyes' countries have also adopted further legislative changes that allow disruption of terrorist attacks by reducing thresholds law enforcement and intelligence agencies need for reasonable suspicion in order to access both electronic and human intelligence (humint). governments desire to do something to reduce the threat and risks posed by terrorists by creating increasingly proactive, flexible and permissive legislative environments has also raised concerns about the role of intelligence, secrecy and privacy. these issues will be discussed as they relate to the bio-threat and risk context in chapter 8. but legislation is only one plank in effective counter terrorism and the scale and pace of actual and potential terrorist attacks suggest other disruption strategies are required at the tactical level. innes et al. suggest such strategies might include: 'prosecution against an individual or a network for offences other than those they were principally being investigated for and/or interfering with the operations of the criminal enterprise in cases where there is insufficient evidence to secure prosecution ' (2017: 265) . they add that, at the tactical level, disruption strategies can 'interfere with the ability of suspected adversaries to operate effectively and efficiently' (ibid.). innes et al. suggests that tactical disruption functions at 'near event interdiction', which can mitigate or minimise harms associated with the actual or planned terrorism attack (ibid.). other counter-terrorism disruption strategies in 'five eyes' countries have included the creation of cve policies and interventions as well as the disruption or take down of social media venues advocating politically motivated violence or recruitment to jihadist groups. regardless of the complexity of post 9/11 terrorist attacks-such as the multi-site attacks in paris 2015 orchestrated by a group; or the knife attack against two police officers in australia in 2014 by one individual-disruption strategies employed by law enforcement and national security intelligence agencies are also likely to be usefully employed in the bio-threat and risk context. just how useful strategic and tactical disruption strategies used in conventional counter-terrorism will be in the bio-threat context depends on the nature of the intent and capability of individual threat actor(s) and the risks posed by their actions. the effectiveness of disruption strategies in the bio-threat context like conventional terrorist attacks are contingent on a range of variables that are unique to that event. in the bio-threat context, leaving aside large levels of uncertainty about the future threat trajectory for bio-terrorism, effective disruption will rely on law enforcement and intelligence agencies understanding how the intention, capability and opportunities of threat actors operating in a particular environment-make an attack possible. intention, capability and opportunities will differ along the threat continuum from individual to group and from state to non-state actor. for example, in the research facility, hospital or high containment laboratory environment, intention, capabilities and opportunities may be shaped by actors that are internal, external or an indirectly involved in the facility (perman et al. 2013: 95) . threats can also be as perman suggest overt or clandestine (ibid.). in some cases, if a scientist is motivated politically (for religious, environmental or political reasons) to commit an act of violence by using a biological agent it may be easier to disrupt their activities if they are public about their agenda. however, in the case of a clandestine plan it could be very difficult to disrupt an attack launched externally or internally in a contained lab. nonetheless, as we saw with historical cases of lone actor threats such as the bruce ivins amerithrax incident there are likely predicate steps in the process to carrying out an attack which are revealable. similarly, in the lesser known case of dr. larry ford, who was suspected of murdering his business partner in a biotech company-the police subsequently found a cache of weapons, white supremacist writings and allegations that he attempted to infect six mistresses with biological agents (perman et al. 2013: 94) . again even in cases of lone actors such as this whose attack planning is more clandestine; there may well be an abundance of 'warning intelligence' that if collected and assessed in time might be useful in disrupting a lone actor planned attack. while it can be difficult to disrupt a lone actor plot, more elaborate ones by a group of conspirators could in some circumstances provide greater opportunities for interception and disruption by law enforcement and intelligence agencies. this is because in plots involving multiple actors there are more stages before the attack can be carried out. some stages such as communications, procuring supplies and transport also provide points of vulnerability, where threat actors can be exposed to authorities and disrupted. so an external threat such as a terrorist attack against a high containment laboratory might involve communications amongst group members, financing of the plan, purchasing of explosives and surveillance of the facility's perimeters. each stage presents opportunities for disruption providing intelligence and information is available to law enforcement and intelligence agencies. similarly a theft of intellectual property or biological material from a private sector biotechnology company might result from either an external criminal group; or state actor pressuring or paying an employee to steal information on their behalf. again, intelligence may exist already about the criminal group or the compromised employee that provides opportunities for disruption. in an ideal world of course, it would be desirable if all potential biothreat and risk scenarios could be prevented early in the intent stage, where they are mainly an idea in a perpetrator's head. pre-employment screening, including criminal checks and select agent risk assessments will show up some individuals, who are not suitable to access and work with dangerous biological agents. this will have an early disruptive effect but it is not fool proof. people can lie about their circumstances in security suitability checks allowing them the ability to access and plan malevolent acts in a secure biological facility rather than just thinking about them. once operating inside a facility-depending on the nature of the planned attack it can be very difficult for law enforcement and the intelligence community to respond quickly enough to disrupt the attack before its fully implemented. in all threat scenarios (simple to complex) in addition to the mandatory background checks for workers, each scientific institution needs to develop a full suite of threat assessments that can be updated regularly on different threat actors, including but not limited to: visitors, criminals, lone actor attacks (internal and external), terrorist and issued motived groups, international terrorists groups and foreign powers (perman et al. 2013: 94) . these threat assessments should be developed by an institution's internal security department in collaboration with local law enforcement. the relatively low number of threat scenarios that have taken place involving bio-agents since 9/11 will likely mean that there will be many intelligence gaps in assessing the intent, ability and opportunity of different threat types. however, providing baseline threat assessments will begin to build pictures of threats scenarios that should help promote better biosafety measures as well as opportunities to disrupt threats earlier should they begin to emerge. in summary, law enforcement and intelligence agencies working on bio-threats and risks of the future can learn a lot from their counter terrorism colleagues. since 9/11, countering terrorism continues to produce lessons for the law enforcement and intelligence communities on how more effectively to disrupt emerging terror plots before they are implemented. the knowledge gained from investigating conventional terrorism attacks that don't involve biology can help those working on future bio-threats and risks by seeing how to optimise the legislative, intelligence, investigative and community response to terrorism while also learning lessons from contemporary counter terrorism efforts. in particular, the increase in lone actor terrorist attacks in the westoften with short notice underscores that either an insufficient amount of intelligence or types of intelligence that cannot be revealed in court often exists. in these cases, other tactical disruption strategies are gaining traction amongst 'five eyes' countries to mitigate the threat and harm posed by terrorists. similarly, given the complexity of threat scenarios that could arise from the exploitation of dual use biotechnology, it may be difficult in some cases to collect sufficient solid 'evidence' or use bio-forensics to attribute confidently for a conviction on bioterrorism or bio-criminal activity. nonetheless, the various counter terrorism strategies discussed above point to ways threat actors may be disrupted on lesser offences while also providing a greater intelligence dividend on other individuals involved. the final knowledge area and stakeholder group that intelligence agencies and investigators working with bio-threat and risks may learn more from is cyber security. as koblentz and mazanec (2013) suggest there are a lot of common characteristics between biological and cyber weapons including but not limited to: difficulty of attribution and how multiple technologies can be used for offensive, defensive and civilian applications (421-425). both authors argue because of these similarities there is likely a lot cyber can learn from how bio-threats have been managed historically. this is undoubtedly true, though in this section the focus will be the opposite-i.e. what can intelligence and investigative agencies working on bio-threats learn from the cyber threat and capability landscape? even a cursory review of the literature suggest that there are a number of areas where current cyber research and practice could inform the 'five eyes' intelligence communities understanding of current and emerging bio-threats and risks. space does not allow an exhaustive discussion on all of them, but there are three cyber areas in particular; where i believe those working with bio-threats and risks could benefit greatly from knowing more about in order to learn the lessons from the cyber context as well as identifying good intelligence and investigative practice. these areas are: the dark web, cyber terrorism and cyber espionage. i will discuss each briefly in turn. turning to the dark web environment first here we are referring to the content on the internet that is 'not indexed by standard search engines' (weimann 2016: 196) . much of the dark web is hidden or blocked and can only be accessed by specialised browsers. given the relative anonymity it provides, the dark web has seen the proliferation of child pornography, credit card fraud, identify theft, drugs and arms trafficking amongst other illicit offences. the dark web only emerged in recent years though law enforcement and intelligence agencies have made some in roads into its penetration and disruption. the fbi's shut down of the dark web site silk road, which operated between february 2011 and october 2013 was to that point the largest and most sophisticated anonymous online market place for illicit drugs (zajã¡cz 2017) . new technological solutions are also being developed to better identify, collect and analyse illicit activity on the dark web, including darpa's memex software, which helps catalogue dark web sites (weimann 2016: 203) . nonetheless, all 'five eyes' intelligence communities will need to continue to develop their collection, analytical and investigative capabilities in the dark web content to profile more accurately various illicit market places in order to orchestrate impactful disruption activity across multiple markets. although it is unknown, at least in an unclassified sense the extent to which illicit markets exist that could benefit bio-threat actors (criminals or terrorists), undoubtedly law enforcement and intelligence agencies, who are given a watching brief on emerging bio-threats and risk should be exploiting the dark web more for opportunities for disruption. a first step might be first to map the bio-terrorism literature and identify researchers, who have access to bioterrorism agents/disease research, domain, institutions, countries and emerging topics and trends in bioterrorism agents/disease research. chen shows how by using informatics research it might be possible to use knowledge mapping techniques, to analyse productivity status, collaboration status and emerging topics in the bio-terrorism domain (chen 2011: 335-367) . additionally, other intelligence and investigative teams that are working on non-bio threats such as conventional terrorist attacks, terrorism financing, drug trafficking or even child sexual exploitation may come across offenders, who have links to others interested in exploiting dual use biological agents for malevolent objectives. so the work currently going on by intelligence agencies working on broader cyber security issues such as cybercrime or cyber terrorism is directly relevant to improving collection and analysis against emerging bio-threats and risks. developments in the second area cyber-terrorism provides another opportunity for bio-threat intelligence and investigative teams to learn off their colleagues working on cyber threats. in the past we often think about the classical 'bio-terrorism' attack involving the aerolising and dispersal of a dangerous pathogen like anthrax into a crowded place. this mode of attack may still be chosen in the future by a terrorist group (leaving aside for a minute the technical difficulties of such an attack). though committed acts through cyber opens up other choices for a bio-attack. cyber security specialist's knowledge of cyber terrorism is still developing. we have seen for example groups like the taliban and is increasingly use computers for recruitment, propaganda and communications, but it remains difficult to know empirically how many of the current virtual attacks such as ransomware can be attributed to terrorist or led to deaths or impacted critical infrastructure in significant ways. such attacks could just as easily be attributed to cyber hackers (criminals) or state sponsored espionage both issues we will return to shortly (riglietti 2017; bernard 2017; heicker㶠2014) . nonetheless, it is clear that terrorism groups are increasing their use of computers including the dark web given they know that intelligence communities are monitoring the surface internet and social media. in august 2014, al-aan tv reported a laptop belonging to a tunisian member of is captured in syria contained thousands of documents from the dark web including 19 pages about making biological weapons in a way to impact the biggest number of people (weimann 2016: 200) . there have also been cases where is has carried out a series of cyber-attacks, 'exclusively computer based, which in one instance even led to the disclosure of private information regarding us government officials, from private conversations to work and email addresses' (riglietti 2017: 19) . the final area of cyber security that is useful for bio-threat intelligence and investigative teams to reflect on relates to cyber hacks and espionage. putting hacks and espionage together is not meant to suggest that both are always linked-though we have seen in the russian interference in the 2016 us presidential election they can be. china too is playing an increasingly sophisticated and aggressive cyber espionage strategy aimed at political interference and stealing intellectual property (inkster 2015) . there seems little doubt that the extent of hacking (unauthorised access to a computer or network) being perpetrated by state and non-state actors is on the rise and network vulnerabilities across the civil and military space remain. in a recent article, fbi assistant special agent in charge (chicago), todd carroll said the average time between an unauthorised user getting inside a network and the user being detected is 150 days-'a lifetime in cyber means'. todd went on to say that 57% of business owners don't have a dedicated employee or vendor monitoring for cyber-attacks (stone 2017) . we have also seen in recent years the growth in malware and ransomware attacks across the globe. for example, in 2017 the wannacry ransomware attack caused 230,000 infections across 124 countries (locking down banking, energy and manufacturing systems) (schilling 2017) . the dark web also provides terrorist and criminal groups opportunities to operate botnet campaigns in anonymity that can remotely operate networks of computers to commit attacks on other systems including critical infrastructure. again there is insufficient space to provide a full survey of all the cyber hacking and espionage threats, and indeed what to do about them is beyond the scope of this chapter (clarke and knake 2010: 257-280) . nonetheless the hacking attacks-whether they are state sponsored (espionage) or non-state actors (terrorists or criminals) provide another rich source of knowledge to be collected and assessed that can be used by those working on emerging bio-threats and risks. for example, it would seem unwise for bio-threat intelligence and investigative teams to not learn from the fast changing angles of cyber-attack from hackers given how the physical security of biological institutions, their intellectual property and the kinds of biological products produced in such facilities is reliant on secure cyber systems. we have seen in recent years the take down of government websites involving ransomware attacks on both government and private sector networks. increasingly more information is being shared and stored via the cloud. what would be the impact of a major ransomware attack that locks down the entire bio-surveillance capability of a public health authority such as cdc do to maintaining national health security? could a cybercriminal group infiltrate the network of a major biodefense company steal ip and sell it to a terrorist group on the dark web? could research stored via the cloud on non-secure networks relating to the genetic sequences of pathogens be stolen by a terrorist group or state actor to engineer bio-weapons? (blue ribbon project 2015: 44-46) . in all the three areas discussed above, a fuller development of links between those working in the cyber intelligence collection and analysis streams, and those who might examine emerging bio-threats and risks is a necessary first step in bringing relevant knowledge and practice from cyber security to bio-threat stakeholders. in this final section the attention is turned to what kind of stakeholders play a role in treating bio-threats and risk? second, in performing these roles, how can they help the 'five eyes' intelligence communities build better capability (knowledge, practice and technology) about treating actual or emerging bio-threats and risks? as we have seen so far the management of bio-threats and risks is potentially a crowded enterprise with many stakeholders (beyond the intelligence communities) playing critical roles. in this section, i have grouped them into three 'types of stakeholder': first responders, science and technology stakeholders and security stakeholders. these are not three distinct clusters of unique stakeholders that do not interact with each other. depending on the nature of the bio-incident that has occurred, one would expect to see a close interaction amongst the various knowledge brokers and practitioners from each group. for example, a release of a synthetically manufactured select agent in an airport should result in the combined strategic and tactical contributions from first responders, engineers and security personnel rather each being delivered in isolation. an uncoordinated delivery of knowledge, practice and expertise to treat an unfolding bio-threat/risk from multiple stakeholders will not result in the best outcome for mitigating the risk or disrupting future potential of similar threats occurring. again as with previous sections, the focus here is not a deep exploration of the specific knowledge, practice or technology of all stakeholders involved potentially in the treatment of bio-risks. this would be an impossible task. instead this section will explain briefly what each of the three broad stakeholder categories (first responders, science and technology and security) can do broadly to treat bio-risks (current or potential), what intelligence communities can learn from this in ways that extend their capabilities to manage bio-threats and risks. the label 'first responders' is a descriptor for a much broader range of stakeholders including: fire/hazmat, paramedics, emergency responders, health and hospital service providers. each would play a different role in both responding to and treating a bio-incident depending on the type of biological hazard, their jurisdictional and legislative responsibilities and fiscal capacity. in all 'five eyes' countries with perhaps the exception of new zealand (with a smaller population and only one national government) the complexity of response will be particularly governed by the overlapping roles that various local, state and federal first responders might play. obviously in the us with multiple federal, state and local agencies, the coordination of first responder efforts to a bio-incident presents more challenges than other 'five eyes' countries such as australia and the uk with less agencies and jurisdictions. there is not an abundance of academic literature on the role of first responders in treating bio-threats and risks. this lack of evidence makes it difficult to assess accurately what first responders can do to treat bio-threats and risks, what the challenges are and what the intelligence community can learn from these important stakeholders. there is however, some research available that can increase the intelligence communities' understanding of first responder capabilities to treat bio-threats and risks as well as illuminate some of the challenges in doing so. this research should provide at least a start to what the intelligence community can learn from first responders as they deploy their knowledge and practice to disrupt and treat bio-threats and risks. 9/11 and the amerithrax incident provided a catalyst for law enforcement and public health agencies to work closer together to respond to an unfolding threat. since amerithrax, across the 'five eyes' countries further work has been done to better coordinate the work of law enforcement and public health agencies on treating bio-threats and risks. but such efforts have not involved routinely the broader spectrum of national security intelligence agencies, who have tended to play a more strategic and adhoc role compared to their law enforcement counterparts. overall, policy, coordination and legislative efforts to bring first responders and members of the intelligence and law enforcement community together have had only mixed success for a number of reasons. in 2007, a study of how law enforcement and public health agencies in the us, canada, uk and ireland work together on bio-threat incidents identified several common barriers to improving multi-agency responses (strom and eyerman 2007) . these included cultural, legal, structural, communication and leadership barriers (ibid.: 135). ten years on from strom and eyerman's research, other researchers have made similar observations about the ability of first responders to manage effectively a bio-threat incident and to work with law enforcement and intelligence community on such tasks. but it's not just the capability issues raised above, other research points to other technical challenges to treating the impact of bio-threats and risks in the physical environment. for example, research by chemists and environmental engineers show that given the varying nature and strains of the bacteria-the science for assessing risk of exposure may not be able to provide a fully accurate risk assessment of a building's vulnerability or resilience to a bio-attack nor-in some cases whether first responders have effectively 'cleaned the environment up after exposure' (canter 2007; taylor et al. 2013) . a lack of effectiveness in responding to a biothreat incident in a local area obviously can have broader public sector implications in both treatment and preparedness of bio-risks. for example, gerstein (2017: 86) citing a study by advocacy group trust for america's health reported that 26 states and dc scored 6/10 or lower on a scale for preparedness. additionally, since 9/11 major disease outbreaks such as sars and ebola have also demonstrated fragility in parts of the world, including some 'five eyes' country's public health response capability, which remains a concern if there was a major bio-terrorist event. the blue ribbon study project report raised similar concerns about the capability of certain responders including those local, state and federal agencies that might be involved in decontaminating sites following a bio-incident. in the us, the report raised similar coordination issues between federal, state and local agencies in which first responder agency would take the lead in decontaminating and remediating environments and how other agencies would get involved to ensure the attack site was deemed safe for people to return (blue ribbon study project 2015: 26). one underlying theme arising from the studies mentioned on first responder's roles in treating bio-threats and risks is that the intelligence community must share more information with emergency services on the nature of the threat they are meant to respond to. this is not to suggest that in all the 'five eyes' countries that no sharing is going on. my selected interviews with law enforcement and intelligence officials in each country did not give the impression that no sharing was going on with first responders. however it is clear if the local fire officers or emergency staff in a hospital are meant to better respond to a bio-incident they will need regular, consistent, reliable, real-time information and intelligence. this is vital to them safely securing the scene, or rapidly diagnosing and treating infected patients while also keeping themselves safe. importantly too, the more intelligence they receive will likely be helpful in first responders preserving any relevant evidence from the scene that might be needed by the either the law enforcement and intelligence communities. gerstein makes a valuable point when referring to improving bio-preparedness and response activities, when he suggests that first responders need to be seen as part of a complex system rather than each representing a series of programs (gerstein 2017: 88) . in addition to the range of knowledge and practice the intelligence community can learn from first responders, arguably the biggest lesson they can learn is to seek to better understand the 'linkages among disparate disciplines (biodefense, public health, emergency management), government, industry, the scientific community and themselves to better support first responders' (ibid.). if the 'five eyes' intelligence communities were able to create the necessary national health security coordination arrangements suggested in chapter 6 such as the health security coordination council and the national health security strategy, then through these institutions further intelligence sharing mechanisms could be established to improve information flow between the intelligence communities and first responders at federal, state and local levels. however, first further research is required to investigate how law enforcement and intelligence communities work currently with first responders to identify and as much as possible ameliorate the cultural, legal, communication and leadership barriers that persist. a second cluster of knowledge and stakeholders for treating bio-threats and risks could be loosely described as 'science and technology' stakeholders. in earlier sections, under the relevant headings (prevention and disruption), significant space was devoted to how our intelligence communities can learn from a range of stakeholders working across a diverse array of disciplines (including bio-surveillance, public health, biosafety, criminology, counter terrorism and cyber). in each of these disciplines, discussion included exploration of relevant science, technology and knowledge useful for the intelligence community in preventing and disrupting bio-threats and risks. some of that discussion, for example bio-surveillance, biosafety and strengthening global health is also relevant to our focus here in treating bio-incidents. however, in this section the focus is not what the intelligence community can learn from stakeholders working in the above disciplines, but rather what they can learn from disciplines more removed from the biological sciences or relevant social sciences (e.g. engineering or security studies). what can the intelligence community learn from physical, mechanical or environmental engineering? there are multiple roles engineering specialties could play and are playing in preventing, disrupting and treating bio-threats and risks. for one and historically, the us dod has relied on engineers, microbiologists to provide advice on weaponisation of biological agents under a range of scenarios and conditions (state actor and terrorists threats). for example, even pre 9/11, between 1999 and 2000 dtra funded project bacchus to see if a team of scientists and engineers, who allegedly did not have extensive experience in bio-weapons could make bio-weapon facility using just commercially available items. the objective was to see if the team could make anthrax successfully without the detection of the intelligence community, though it was later revealed that this team did have substantive technical knowledge and support throughout this project (vogel 2013: 41-43) . engineers have also long been engaged in studying aerolisation dynamics, which has become increasingly a multi-disciplinary collaboration of environmental engineers, biomedical engineers, microbiologists, chemists and epidemiologists (xu et al. 2011) . related to aerolisation studies has been the work of hardware and software engineers-many of whom came from the aerospace and automotive industries that have brought their skills into modelling bio-terrorism attacks to help first responders predict how airborne particles might move through sections of a city under certain weather and windflow conditions (thilmany 2005) . other engineering studies, sometimes referred to bio-protection studies have been important in the design of the heating ventilation and air conditioning (hvac) systems used to resist biological contaminants. much of this research became activated after the amerithrax incident, and is designed at reducing the health consequences from airborne contaminants by augmenting heating and air conditioning systems (ginsberg and bui 2015) . another focus of engineering led research relates to improving the portability, speed and reliability of bio aerosol monitors for pathogens. one recent study has been working on a device that would be fully portable and automated-capable of detection of selected air-borne microorganisms on the spot-within 30 to 8 minutes depending on the genome and particular strain of the organism (agranovski et al. 2017 ). in this last sub-section in our exploration of what other stakeholders may be useful in treating bio-threats and risks we turn our attention to the role of security officers. i am conscious in the discussion above regarding prevention and biosafety much was said about the role of security officers and managers in promoting biosecurity and biosafety across all sectors of the bio-sciences enterprise (e.g. research centres, hospitals, biotechnology companies, public and private labs). in this section, we focus instead on the role of security officers and managers across the broader economy-beyond biosciences. as argued in previous chapters, in addition to taking a one health perspective to bio-threats and risk, 'five eyes' intelligence communities and their law enforcement colleagues need to also understand the potential development of biothreats and risks beyond the technical world of biotechnology and labs to include also in their wider social, economic and community contexts. hence in this section, we are referring to the role of security officers and companies that work across the international, national, state and local economies in each 'five eyes' country. given the trajectory of most (if not all) future bio-threats is unknown, our intelligence communities need to be forging more formalised (less adhoc) relationships with security officers in a range of non-biotechnology industries (banking, mining, food supply, agriculture, critical infrastructure). as nalla and wakefield (2014) argue several factors have increased the role of private security since the second world war. increased economic wealth, enhanced security technology (alarms, access control and cctv), in addition to an increase in the control by a number of private sector companies of publicly accessible places have, amongst other factors all contributed to the growth in private sector security (ibid.: 727). while it is difficult to generalise 'as the functions of security officers/agencies are as varied as the organisations that employ them' (ibid.: 731), their functions and roles cut across many facets of each 'five eyes' nation to include office buildings, warehouses, shopping malls, education establishments, residential complexes and critical infrastructure. one often thinks of the classic scenario of a security guard standing in front of a physical gate, which is one role of many others which might also, depending on their functions include traffic control, surveillance, responding to emergencies, security vetting. in the security role of complex large companies, airports and electricity plants, it is likely that the security officers will have a deep understanding of their physical and virtual security environments and this kind of expert knowledge would be integral for them and the intelligence community gaining threat awareness, prevention, surveillance, disruption, treatment and recovery to bio threats and risks which may manifest in their operating environment. historically however, the relationship between intelligence communities (including law enforcement) and private sector security has not been optimal partially because a lack of trust between both (ibid.: 739). however, several studies on private and public sector security do show several areas of improvement across each 'five eyes' country. some of these improvements have been initiated by governments such as in the uk making significant cuts to policing in the late 1990s and mid-2000s and seeking the private sector security sector to pick up more cheaply what were considered less core policing such as offender management and transfers of prisoners. in other cases, governments were interested in engaging with the private sector to extend their own security and intelligence collection capabilities with terrorism. connors et al. (2000) , wakefield (2003) , and rigakos (2002) provide more detailed analysis of a range of factors that have been involved in building partnerships with private sector security companies in the us, uk and canada respectively. 9/11 and of course subsequent terrorist attacks in many western countries has seen a more focused attempt by 'five eyes' countries to reach out to the private sector-including private sector security given many attacks occur in public places owned or managed by the private sector. threats as well to public and privately owned critical infrastructure (aviation, power, water, and telecommunication) have also influenced 'five eyes' government's closer liaison with the private sector. for example in the us, dhs has established a private sector office to provide government advice on relevant security issues to the private sector as well as promoting public-private partnerships. in australia, since 9/11 parts of the australian intelligence community, particularly asio has developed closer links with the private sector. in 2004 australia's attorney general's department created the business-government advisory group on national security to provide a vehicle for the government to discuss a range of national security issues and initiative with ceos and senior business leaders (dpm &c 2015: 6). the group later (2014) evolved into the australian governments industry consultation on national security (ibid.). more recently (2017) the australian government released its strategy for protecting crowded places from terrorism. this significant policy document was developed in close partnerships with federal, state and local governments, the intelligence community and the private sector. the key objective being to assist owners and operators to increase the safety, protection and resilience of crowded places across australia (anzctc 2017). an interesting aspect of this strategy is that it places the primary responsibility for protecting sites and people on private sector businesses. similar policy articulations have been declared in the uk's counter-terrorism strategy (hmg 2011) and canada's approach to counter-terrorism (canadian government 2011). in summary, it's clear that various agencies of the 'five eyes' intelligence communities and their broader law enforcement counterparts have increased their liaison and implemented various initiatives with private sector industry. what is less clear is the nature and extent of these as they relate to the prevention, disruption and treatment of potential bio-threats and risks. much is unknown, for example, about whether intelligence and law enforcement communities are actively working in partnership with the private sector beyond the classical threat typologies of basic terrorist's tactics, improvised explosive devices or vehicle born attacks. given the low probability high impact nature of the evolving bio-threat environment, it is likely that many private sector companies (banking, shopping malls, mining, hotels) see little need to include bio-threats in their security risk management plans or indeed consult with intelligence and law enforcement communities on them. while it is important not to be alarmist on low probability threats that are more likely on balance to effect the biosciences community rather than the broader private sector economy, it seems unwise for the latter not to consider the impact of such bio-threats on their operations and to at least have formalised dialogues on these with the intelligence community. but such a dialogue will in the future rely on several factors identified already by researchers coming together to develop more effective public-private crime prevention strategies. prenzler and sarre list several factors including: a common interest in reducing a specific crime, leadership, mutual respect, information sharing based on high levels of trust in confidentiality and formalised mechanisms for consultation and communications (prenzler and sarre 2014: 783) . this chapter surveyed the role of external stakeholders external (to the 'five eyes' intelligence communities) in preventing, disrupting and treating bio-threats and risks. depending on the particular bio-threat a diverse array of stakeholders could provide knowledge, skills and capabilities to the intelligence community. the large number of disciplines and stakeholders with relevant technical knowledge suggest that they will continue to play a critical role in the prevention, disruption and treatment of bio-threats and risks. in many cases, such as in biosurveillance, forensics and even engineering the scientific and technical stakeholders discussed here may play a greater role than the traditional intelligence and investigative response to managing bio-threats and risks. the chapter also highlighted that although each 'five eye's intelligence community has a wealth of knowledge to tap into from stakeholders, however in most cases all stakeholder groups are faced with their own theoretical and practical limitations. analysts and investigators working on bio-threats and risks need to understand these limitations while also seeking to build deeper and more formalised partnerships with scientific, technical and cross disciplinary stakeholders. in the final chapter 8, we shift the focus away from the practice and processes involved in interpreting bio-threats and risks to oversight and accountability issues. given the legislative, ethical and normative challenges modern intelligence practice faces, particularly in understanding the potential threat trajectory of synthetic biology, what role can oversight and accountability play in achieving the objectives of the intelligence communities in liberal democracies? miniature pcr based portable bioaerosol monitor development australia's strategy for protecting crowded places from terrorism. anzctc, australian government biological weapons-related common control lists biosafety and biosecurity as 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dark: terrorism on the dark web ebola virus disease in west africa-the first nine months of the epidemic and forward projections signal recognition during the emergence of pandemic influenza type a/h1n1: a commercial disease intelligence unit's perspective. intelligence and national security utility and potential of rapid epidemic intelligence from internet-based sources labs cited for 'serious' security failures in research with bioterror germs silk road: the market beyond the reach of the state key: cord-034684-ehaiqye5 authors: peterson, ryan r. title: over the caribbean top: community well-being and over-tourism in small island tourism economies date: 2020-11-05 journal: int doi: 10.1007/s42413-020-00094-3 sha: doc_id: 34684 cord_uid: ehaiqye5 the caribbean is one of the most tourism-intense regions of the world with rising levels of over-tourism, especially in dependent small island tourism economies (site). more critically, mounting socio-ecological pressures are compounded by increasing climate change and enduring social vulnerabilities, thereby challenging traditional policies and paradigms of growth and sustainability. drawing on previous studies of inclusive development and community well-being, this research paper frames and extends the phenomenon of over-tourism from a political economic perspective. based on a historical account of small island tourism development, an in-depth case study of aruba is presented. recognized internationally as the ‘one happy island’ and one of the most tourism-dependent small island economies, the findings yield a contextualized understanding of the complex and dynamic nature of over-tourism, and identify the main antecedents and effects of over-tourism. the study discusses the evolving economic disconnectedness, environmental decay, social inequality, and institutional failures. the findings describe the role of institutional capture and policy drift which stem primarily from political as well as market forces, and have resulted in a gradual marginalization of community well-being and agency. the paper proposes an extended conceptualization of over-tourism in small island tourism economies by explicitly recognizing that the crux of the over-tourism conundrum in site is political in nature and institutional by nurture. recommendations are provided for transitioning towards community-driven development by building capabilities and pathways for innovation, internalization, and institutionalization in order to strengthen the resilience of small island tourism development. what started as a casual affair almost a century ago has today turned into one of the most vibrant and fastest growing industries. up until the covid-19 pandemic, the caribbean was one of the most tourism-intense regions of the world with international tourism contributing, on average, to 20% of exports, 15% of gdp (gross domestic product), and 14% of labor (wttc 2019). likewise, accounting for at least 13% of capital investments, international tourism is one of the most resource-intense industries, including financial, human, and natural resources in the caribbean (mcelroy and pearce 2006) . over the past 50 years, caribbean tourism arrivals have grown tenfold, from less than 5 million visitors during the early 1970's to well over 50 million tourists today and is expected to continue to grow in the next decade (wttc 2019). yet paradoxically, despite this significant and continued tourism growth, there are increasing signs that economic growth has largely stagnated across the caribbean, especially in the smaller and more tourism-dependent island economies (acevedo et al. 2017; ruprah et al. 2014; peterson 2019; leigh et al. 2017) . initial evidence suggests that the surge in international tourism has not contributed significantly to the lackluster economic growth since the early 2000's (chamon et al. 2017) . this precarious reality is consistent with previous studies reporting stagnant growth and diminishing productivity in caribbean tourism economies (ruprah 2014; peterson 2016) , which could be indicative of a maturing of tourism destinations along the tourism life cycle (butler 1980) , or more poignantly, a self-destructive tourism fetish with growth and expansion beyond the destination's socio-ecological capacities (higgins-desbiolles 2018). the confluence of enduring tourism growth with diminishing economic development in small island tourism economies (sites) raises serious questions about the role and contribution of tourism for inclusive development and community well-being in the caribbean (unsdg 2018), especially considering the complex of economic, health, and environmental shocks in addition to the longstanding social vulnerabilities and institutional weaknesses (imf 2017; ruprah et al. 2014; peterson 2019) . whereas tourism specialization is traditionally associated with economic production and growth (cannonier and galloway 2019; de vita & kyaw 2016; marsiglio 2018) , the adverse externalities thereof are, however, also well established (daye et al. 2008; duval 2004; gossling 2002; hall and williams 2008; mcelroy 2003; peterson 2009; wilkinson 1989) . furthermore, the relationship between tourism specialization and economic growth is moderated by absorptive capacities (acemoglu & robinson 2012; baldacchino 2006; brautigam and woolcock 2001; peterson et al. 2017 ), which describe the optimum level of tourism specialization that can be assimilated and absorbed by an economy before reaching an inflection point after which tourism specialization experiences diminishing returns and negative externalities (de vita & kyaw 2016; marsiglio 2018) . in terms of the tourism surge in the caribbean, mcelroy and pearce (2006) contends that part of the problem in the caribbean is that much of the tourism growth since the early 1990's too fast, unregulated, and fragmented. according to farrell and runyan (1991) , this rapid and unbalanced growth of tourism produces an inherent propensity for environmental overrun and sociocultural disruption, which in due course affect economic sustainability and societal well-being. as the intensity and concentration of tourism growth increases, the capacity of delicate socio-ecological island systems to absorb these changes can be drastically exceeded and may produce undesirable resource degradation (farrell and runyan 1991) , ironically destroying the very seeds of their previous success. when reviewing the history of tourism in the caribbean, it is blatantly apparent that growth rather than development remains the overriding focus. a perusal of caribbean tourism destination websites and the caribbean tourism organization (cto 2020) reveals that the dominant modus operandi is geared at increasing arrivals and industry revenues, attracting investments, creating jobs, and expanding cruise-lines and accommodations infrastructures; all in the name of economic growth and wealth hoarding. exemplary of this continued tourism rhetoric is the recent caribbean push towards inclusive tourism development by focusing on the market acceptance of new tourism services and how community tourism can support product differentiation with the ultimate benefit being the creation of a distinctive tourism brand that stimulate economic growth, productivity, and competitiveness (cto 2019). still couched within a narrow neoliberal tourism agenda, quality of life, shared value, environmental conservation, and community well-being are at best subjugated in national tourism policies that pay little more than lip service to the various principles of inclusiveness, integrity, equity, and sustainability (daye et al. 2008; duval 2004; joppe 2019; peterson 2009; scheyvens and biddulph 2017) . even if considered as an afterthought or part of the tourism destination's strategy, no formal system for measuring and monitoring non-economic impacts is implemented. contrary to the espoused national agendas for a sustainable tourism destination, in situ political agendas are largely cloaked for sustaining a tourism industry and have largely eclipsed social rights and responsibilities, de facto subduing the role of government and civic organizations to govern for the generaland futurewell-being of society (higgins-desbiolles 2018). more importantly, many small island communities across the caribbean continue to scream in silence for responsible and inclusive tourism (cole 2007; duval 2004; peterson et al. 2020) . reminiscent of polanyi (1944) and despite some of the nascent benefits of tourism, caribbean societies seem to have become largely subservient to international tourism markets, rather than tourism markets fostering societal well-being on caribbean terms (duval 2004; pattulo 1996; sheller 2003) . in fact, community and small business tourism in the caribbean oftentimes operate within a context where their viability is largely determined by global and national actors (daye et al. 2008) . the enduring fixation on constant increases in tourism volumes and economic value, and the persistent use and promotion of conventional tourism (economic) growth metrics, are testimony to an enduring obsession with physical expansion that has plagued much of the caribbean; one that is intimately connected to destination politics, power, and political cycles (acemoglu and robinson 2012; bishop 2010; cole 2007; daye et al. 2008; duval 2004; mcelroy and de albuquerque 2002; peterson et al. 2017) . in fact, the political economy of caribbean island tourism is oftentimes riddled by exclusion and extractionrather than inclusion and regenerationas witnessed by several tourism-instigated social disturbances and environmental destruction across the caribbean since the late 1970's (bishop 2010) . over the past two decades, several studies have cautioned against the tourism sprawl of social exclusion and ecological decay, and the dire implications thereof in the long run (daye et al. 2008; duval 2004; joppe 2019; mcelroy and de albuquerque 2002; richter 1994) . moreover, economic considerations and benefits of tourism growth and specialization tend to induce 'tourism myopia'a short-term growth orientation on tourism arrivals, receipts, and (tax) revenuesand trigger a gradual tourism overshoot of socioecological ceilings with significant costs in the medium to long term (dodds and butler 2019; joppe 2019; marsiglio 2017; raworth 2017) . according the richter (1994) , it is ironic that the pace of tourism can do more damage to the societies in which it flourishes through myopic expansion than by community-inclusive development. likewise, crandall (1994) concludes that while tourism is accepted as a significant boon to local economies, there is little realization on the part of tourism elitesthose that benefit most from tourism without carrying the coststhat tourism leads to economic spillovers, social changes, and ecological challenges, especially when unplanned or uncontrolled. although certainly not a new experience, this mounting tourism spillover effect has recently been coined over-tourism (dodds and butler 2019; wttc 2019) . although over-tourism is usually defined in terms of the adverse impact of excessive tourism on (parts of) a destination that influences perceived quality of life of citizens and/or quality of visitor experiences in an undesired way (unwto 2018) , this narrow conceptualization disregards or downplays the political economic role of tourism, especially in the caribbean that is generally characterized by dense and tightly-knit social networks (benedict 1967; daye et al. 2008) . from a political economic perspective, daye et al. (2008) contend that the key to investigating and understanding caribbean tourism development, and especially the 'tourism over-run', is the historical context, local realities, and the 'invisible' interactions that influence tourism policies and decisions. likewise, duval (2004) argues that understanding caribbean tourism requires a historical and contextual understanding of the less-observable social mechanisms and formative political, economic, social, and institutional processes that shape tourism policies and institutional behaviors in small islands. beyond the physical notions or symptoms of overcrowding or carrying capacity (unwto 2018; wttc 2019) , this study contends that, at its core, over-tourism is a manifestation of certain institutional powers and processes, and represents the social overpowerment or disempowerment of a destination community's agency (daye et al. 2008; duval 2004; hall and williams 2008; joppe 2019; mccool and lime 2001; moscardo 2015; richter 1994; williams and ponsford 2008) . within contemporary studies and conventional policies on (over-) tourism, the focus is mainly on rational policy formulation and narrowly defined socio-economic processes, rather than on the political context and institutional frame in which power is wielded and governed to preserve and control existing political economic structures and tourism institutions (acemoglu & robinson 2012; dodds and butler 2019; hall and williams 2008; joppe 2019) . in reflecting on previous studies in the caribbean, duval (2004) argues that too often research interprets results through the lens of apolitical and ahistorical perspectives. thus, the fundamental role of institutional framing and failures remains relatively under-scrutinized in studies on over-tourism (duval 2004; hall and williams 2008; joppe 2019) . furthermore, whereas previous studies on over-tourism relate mostly to metropolitan and city districts, over-tourism in small island communities remains largely void of empirical investigation. moreover, research on international tourism in the caribbean focuses almost exclusively on the independent (sovereign) small island tourism states, while dependent (non-sovereign) island tourism economies are generally less scrutinized and often excluded, largely due to their non-sovereign political status. ironically, these subnational island jurisdictions (snijs) are oftentimes relatively more tourism-intense and prone to over-tourism (baldacchino 2006; mcelroy and pearce 2006; peterson 2019; wttc 2019) . considering the aforementioned challenges in contemporary caribbean tourism and the lack of extensive empirical studies on over-tourism in sites, this paper studies the political economy of over-tourism in a non-sovereign site and presents a historical case study on the evolution and socio-ecological impacts of tourism growth in aruba. the aim of the in-depth case study is to explore the main antecedents, processes, and effects of over-tourism, and contribute to a more comprehensive and contextualized understanding of the complexity and dynamics of over-tourism within the context of a contemporary small island community in the caribbean. hence, this study seeks to address and explain how and why contemporary over-tourism emerges and endures in a caribbean site and therein question existing paradigms and maxims of tourism institutionalization. in stretching the conventional conceptualization of over-tourism and exploring the institutional roots of excessive and unregulated tourism growth in the caribbean, this study aims to explain the political-economic development of overtourism from within a caribbean island perspective. internationally acclaimed as the 'one happy island' and one of the most tourismdependent small island economies (mcelroy and pearce 2006; wttc 2019) , the case of aruba is examined to understand how over-tourism and the impacts thereof have evolved over the past 30 years. aruba is a sub-national island jurisdiction within the kingdom of the netherlands and part of the dutch caribbean. aruba is geographically located in the southern caribbean sea on the peripheral of the caribbean hurricane belt. with a registered population of an estimated 112,000, aruba has a total surface area of 180 km 2 , and a coastline of 69 km. considering aruba's politically dependent status and the extensive tourism history dating back to the early 1960's, the case study draws on a mixed method of qualitative and quantitative methods to examine the political economic and socio-ecological dynamics of over-tourism from a holistic small island perspective. based on an extensive historical economic survey of various social, economic, and environmental policies and indicators, the focal drivers and community impacts of over-tourism are identified. the remainder of this paper is structured as follows. in "theoretical background" section, the theoretical background of this study is discussed by reviewing the conceptual origins of and previous studies on over-tourism, inclusive tourism, communitybased tourism, and community well-being. the research design and methodology are described in "research design" section, followed by a presentation of the main findings in "results" section. the conclusions and recommendations are presented in "conclusion" section. conventionally, over-tourism describes the adverse impacts of uncontrolled tourism growthan overshoot of tourismthat influences the (perceived) well-being of citizens and the degradation of natural habitats and ecologies, which result in diminishing visitor experiences and expenditures, and consequently, stagnating economic returns (unwto 2018). over-tourism portrays relentless, frequently unregulated, tourism growth that has moved beyond the level of acceptable change and absorptive capacity in a destination due to significant levels of tourism intensity (total visitors-to-population), tourism density (visitors per km 2 ), and tourism dependency (tourism exports-to-gdp). the compounding effects result in significant pressures on infrastructure (i.e., congestion, transportation, and energy), resource consumption and pollution (i.e., leakage and waste), spatial and cultural alienation (i.e., real-estate and social identity), and visitors' experiences and residents' quality of life (crest 2018; wttc 2019) . however, contrary to the mainstream beliefs and accepted definitions that overtourism is concerned with the volume of visitors and challenges of, e.g., crowding and congestion, the overshoot by tourism is also reflected in the values and behavioral norms of a destination's institutions, community, and visitors (crest 2018; cole 2007; joppe 2019) . par example, disrupting fragile coastal zones with motorized vehicles, disturbing sensitive turtle-nesting areas, or trashing bio-diverse marine parks are mere examples where the number of visitors may not overwhelm per se. likewise, a single immoral act by a visitor can outrage a community, especially when acts are prohibited or unlawful, yet are tolerated by authorities out of concern for a possible tourism backlash. in the long run, tourism behaviors may become institutionalized until changes are no longer accepted or acceptable by the local community (dodds and butler 2019; joppe 2019; williams and ponsford 2008) . more importantly, the institutional behaviors and ethics of destination governments and authorities are fundamental to understanding the complexity and dynamics of overtourism, especially within the context of small island societies with strong political ties (benedict 1967; bishop 2012) . the crux of the over-tourism conundrum and its resolution are well beyond the boundaries of tourism as an industry; they are political by nature and institutional by nurture (baldacchino 2005; joppe 2019; peterson et al. 2017) . thus, in terms of concept stretching (pearce and butler 1999) and beyond conventional definitions of over-tourism that emphasize tourism intensity and visitor density, destination values and community norms as well as political-institutional ideologies and behaviors are a defining, albeit oftentimes tacit, element of contemporary over-tourism (duval 2004; joppe 2019) . by deconstructing over-tourism from an emic island perspective through a politicaleconomic institutional lens (bishop 2012; duval 2004) , this study addresses the limitations of traditional normative and reductionistic tourism-centric approaches (daye et al. 2008 peterson et al. 2017) , and conceptualizes over-tourism from a contextualized perspective in which both norms and networks of purpose, power, people, and place take center stage in social construction of tourism development and institutional behaviors (cloutier et al. 2019; hall and williams 2008; joppe 2019; richter 1994) . although the adverse effects of excessive tourism are recognized as symptomatic of over-tourism (unwto 2018), fundamentally, over-tourism reflects the exclusion of a destination's community and agency to co-determine its tourism development (daye et al. 2008; giampiccoli and saayman 2018) ; it is essentially about the social overpowerment or disempowerment of a community's voice and choice with regard to the desire, direction, and development of tourism within a specific destination (hall and williams 2008; joppe 2019; mccool and lime 2001; moscardo 2008; richter 1994; scheyvens and biddulph 2017; williams and ponsford 2008) . this underscores both the absence and, consequently, the importance of inclusive tourism governance and community-driven tourism development for safeguarding community well-being (moscardo 2008; scheyvens and biddulph 2017) . the genesis of over-tourism dates back to at least the 1970's and 1980's when initial concerns were raised about the potential adverse social and environmental impacts of uncontrolled tourism growth, and consequently, the long-run economic repercussions thereof (bosselman 1978; budowski 1976; butler 1980; cohen 1978; doxey 1975; dunkel 1984; farrell and runyan 1991; getz 1983; holder 1988; innskeep 1994; mathieson & wall 1982; pearce 1985; richter 1994; wilkinson 1989) . by the early 2000's, several empirical studies reported on the negative externalities of tourism in sites (bishop 2010; duval 2004; mcelroy 2003 mcelroy 2006 sheller 2003) . over the past decade, further evidence has been forthcoming on the role and rise of over-tourism, albeit mainly focused on metropolitan areas and cities (capocchi et al. 2019; crest 2018; dodds and butler 2019; wttc 2019) and world heritage sites (milano et al. 2019; musikanski et al. 2019 ). however, echoing some of the critique on over-tourism (joppe 2019) , much of the conceptual and intellectual work on caribbean island tourism has not progressed much beyond an embryonic stage of objectivistic reductionism (daye et al. 2008; duval 2004; pearce and butler 1999; peterson et al. 2017) . over-tourism extends previous theoretical frameworks and models of tourism lifecycles and complex adaptive tourism systems. the origins can be traced back to notions of the tourism destination lifecycle (butler 1980 ) and tourism carrying capacity (mathieson and wall 1982) , which have been widely discussed in the caribbean. furthermore, the concept of over-tourism underscores the nonlinear, interdependent, and dynamic nature of tourism systems (farrell and twinning-ward 2004) , which encompass several interacting social, political, economic, ecological, and digital subsystems, especially within the small(er) scale of island communities (peterson et al. 2017 ). these complex adaptive tourism systems are 'nested' or embedded within social and political ecologies and often evolve in distinct ways with extensive cascades of uncertain, path dependent, and long-term effects (dodds and butler 2019; farrell and twinning-ward 2004) . as a concept, over-tourism is rooted in development economics and discussions on overdevelopment, overdependency, and overconsumption (kohr 1977; meier and stiglitz 2001) . from a post-development theoretical perspective (cowen and shenton 1996) , over-tourism refers to the social inequality and the environmental destruction due to excessive tourism consumption and tourism-related infrastructure expansion. over-tourism is conceptually embedded in the study of how economies grow and societies change over the course of history (meier and stiglitz 2001) , and is frequently viewed in negative terms as the mutually constitutive reverse of inclusive development and inclusive tourism (gupta and vegeling 2016; unsdg 2018; world bank 2018) . inclusive development focuses on productive employment as a means of increasing income as well as raising standards of living and community well-being (gupta and vegeling 2016; cloutier et al. 2019 ). the quality of opportunity and participation in growth, with a special focus on the working poor and the un(der)employed, are integral to inclusive development (ianchovichina and lundstrom 2009; ranieri and ramos 2013; rauniyar and kanbur 2010) . in development economics, it is not only the rate of real gdp per capita growth that matters, but more importantly, the pattern of labor force participation and income distribution in growth (meier 2001) . essentially, fostering societal and community well-being for cultivating resilient societies takes center stage in inclusive development. gupta and vegeling (2016) emphasize both the social and ecological aspects of inclusive development. whereas social elements address community well-being and participation in labor and consumption markets, ecological elements concentrate on the conservation of local ecosystems, the management of ecosystem services, and the regulation of environmental resources. inclusive development resonates strongly with the community well-being principles of purpose, place, and relation as discussed by cloutier et al. (2019) . these principles describe the nurturing of a shared sense of identity, inclusion, and (intergenerational) equity in societies. community well-being constitutes a combination of multiple factors and conditions that shape community's quality of life, including, social, environmental, economic, political, and cultural factors, which collectively and holistically, describe a community's happiness and well-being (cloutier et al. 2019; musikanski et al. 2019 ). according to scheyvens and biddulph (2017) , the ultimate goal of community-based tourism development is to empower the destination's (host) community in four dimensions, i.e., economic, psychological, social, and political. vanderweele (2019) underscores multiple objective and subjective dimensions of community well-being, and discusses the importance empowerment, trust, and governance for fostering community well-being. moscardo (2015) argues that community trust in tourism institutions is essential to strengthen community capacity and enable community-based tourism development. thereto, community awareness and education, active community involvement as well as community advocacy and the integration of a community's values and aspirations for tourism development are considered pivotal to safeguarding a destination's community well-being (giampiccoli and saayman 2018; moscardo 2019; scheyvens and biddulph 2017) . in the absence of community trust and institutional credibility, a country may soon find itself drifting along the waves and whims of elitist powers to the detriment of society and environment (acemoglu and robinson 2012) . the need for inclusive development stems from the realization that relentless economic growth often gives rise to negative externalities, extractive resource depletions, and exploitative labor practices (raworth 2017) , which are clear and present features of over-tourism and readily acknowledged in caribbean sites (daye et al. 2008; duval 2004; island resource foundation 1996; mcelroy and pearce 2006; pattulo 1996; sheller 2003) . in terms of raworth (2017) , over-tourism is sparked when the ecological ceilings and the social foundations of an economy are depleted. according to scheyvens and biddulph (2017) , one of the most enduring critiques of tourism is its non-inclusive development. they contend that tourism oftentimes provides opportunities for the privileged, creating profits for international (non-local) resorts, and building exclusive enclaves for the rich, thereby excluding the indigenous community, marginalizing local cultures and lifestyles, and depleting scarce natural resources (scheyvens and biddulph 2017) . thus, in terms of safeguarding community wellbeing, inclusive tourism governance is not only concerned with the active involvement and purposeful engagement of the community and civic society but also in the participation and distribution of tourism's benefits, i.e., the realization of shared value from tourism development (giampiccoli and saayman 2018; moscardo 2008; peterson et al. 2020; scheyvens and biddulph 2017) . historically, however, previous studies indicate that caribbean tourism developed in a context of a relatively weak state and marginalized community (pattulo 1996; sheller 2003; daye et al. 2008; duval 2004; peterson et al. 2020) . scant policy attention and political commitment has been paid to improving the involvement of the community in tourism development and the subsequent sharing of value. despite the many calls by international organizations for including the local community in tourism, many contemporary efforts are largely symbolic. even if and when, local stakeholders and civic organizations are invited to participate in tourism decision-making and policy development, their voices and choices are soon forgotten or neglected when plans are implemented. merely creating jobs for the community is not sufficient, especially when these jobs are being created for migrant workers. it is therefore essential that communities are empowered and engaged in tourism planning and at the fore of tourism development (duval 2004; giampiccoli and saayman 2018; moscardo 2008; peterson et al. 2020; scheyvens and biddulph 2017) . the general effects of over-tourism are frequently transmitted through direct as well as indirect channels. direct channels of over-tourism transmission describe diminishing or negative tourism contribution to gdp, declining average visitor expenditures, increasing import leakages, growing resource consumption, high tourism export concentration, tourism price inflation, and expansive government expenditures. overtourism also transmits through indirect channels, which effect local communities and natural habitats. indirect channels of over-tourism transmission include stagnant labor participation rates, limited or declining income equality, uneven income distribution, increasing social costs, foreign-ownership concentration of tourism industry, spatial concentration of tourism industry, real-estate price inflation, environmental degradation, loss of natural habitats, and diminishing contribution of tourism ecological services (capocchi et al. 2019; daye et al. 2008; duval 2004; hampton and jeyacheya 2013; koens et al. 2018; wttc 2019) . however, unlike direct transmission channels of over-tourism, indirect effects often transpire and materialize over extended periods of time and may span several business and political cycles. in reviewing the progressive development and potential challenges of tourism growth across sites, mcelroy and pearce (2006) discusses different interrelated causes of a tourism overrun, defined as high-density tourism with damaging levels of visitation due to tourism's sociocultural pressures and environmental footprint. the critical factors that spur over-tourism in the caribbean include (a) the substantial inflow of foreign private tourism investments; (b) the significant stock and rapid expansion of large-scale accommodation facilities; (c) the growth in air traffic and cruise calls; (d) the increase in labor immigration; and (e) the subsequent rise in unplanned coastal urbanization and real-estate infrastructures (mcelroy and pearce 2006) . previous studies indeed confirm that this system of an interlocked tourism supply chain, including the growth in tourism investments and airlift, and the subsequent expansion of accommodations and required labor, contributes to surging levels of tourism intensity and density in the caribbean, which gradually engenders a state of over-tourism in sites. likewise, cole (2007) indicates that an overshoot in caribbean tourism arises from several interdependent factors, including e.g., (a) surpassing physical limits of beachfront or coastal areas for resort construction, (b) increasing labor migration due to limited local workforce, (c) growing visitors' sense of overcrowding, and (d) an escalation in residents feeling overwhelmed or displaced by visitors and/or immigrant workers. the latter describes intensifying sentiments of visitor annoyance and apathy by local communities (doxey 1975) . the unfolding of these events triggers a spiral of demise where surging small island coastal tourism causes increasing crowding, congestion, and contamination (mcelroy and de albuquerque 2002). frequently, this leads to irreversible ecological destruction, social decay, and aesthetic repulsion, and a further uncontrolled spiraling effect (dehoorne et al. 2010) . the case in point is especially relevant for sites that rely on their natural and social ecologies for safeguarding economic development and well-being. whereas sustainable tourism requires the conservation of ecological integrity and environmental resources, its production is, paradoxically, largely dependent upon the consumption of naturebased tourism experiences (williams & ponsford 2008) . likewise, while much of caribbean tourism is staged by its cultural authenticity and natural hospitality, which are essentially rooted in a community sense and values of well-being, its production is labor-intensive with exhaustive demands on emotional labor (shani et al. 2014; sönmeza et al. 2017 ). this paradoxical ambiguity has epitomized much of the progress, pitfalls, and perils of caribbean tourism over the past century (duval 2004), and underscores the significance of reframing and extending contemporary over-tourism from an emic political-economic perspective. the confluence of policy and market failures intensify the negative externalities due to several institutional conditions, including: (a) a regulatory deficiency in environmental conservation and enforcement, (b) limited economic diversification and innovation, (c) lopsided (private) benefits and (public) costs of tourism growth, (d) marginal social inclusion and non-civic participation in tourism policy and development, and (e) a strong and persistent bias towards short-term tourism promotion, expansion, and growth (bishop 2010; daye et al. 2008 furthermore, the systemic exclusion and disempowerment of the community in tourism decision-making and development is central to the problematique of overtourism and one of the primary institutional root causes for the uncontrolled and excessive growth and expansion in tourism. previous studies indicate that inclusive tourism and community involvement are predominantly inhibited by institutional legacies of centralized governance, market-based tourism institutions, coercive or symbolic community consultations, information asymmetries, and structural deficits in labor and environmental regulation, tourism governance, and community education (cole 2007; joppe 2019; giampiccoli and saayman 2018; moscardo 2008; peterson et al. 2020; scheyvens and biddulph 2017) . beyond the normative value systems of neoliberal tourism policies, williams & ponsford (2008) argue that public institutions and agents tend to circumvent regulations and regulatory enforcement largely due to the economic lock-in of the tourism industry. hall and williams (2008) describe this tourism lock-in as path dependency, which is conducive to institutional failures (e.g., close personal and political ties, and resource dependency), network failures (e.g., information asymmetry, dissonance, and ignorance of new developments), and capability failures (e.g., lack of shared awareness and institutional learning capabilities). in addition to rent-seeking institutional behaviors, tourism institutions are an outcome of political negotiations and choices, which are shaped by the political agency and exercise of preferences and power (hall and williams 2008) , thereby increasing the risks of institutional capture, which isbeyond tourism density and intensityintegral to deconstructing over-tourism in contemporary island perspective. institutional capture occurs when an institution or a (minority) collective of agents acts to secure the commercial or political interests of a specific industry or constituency over and above the general interest of, e.g., the public or the community (acemoglu & robinson 2012) . this wide-spread phenomenon in the caribbean (bishop 2010; duval 2004; daye et al. 2008; mcelroy and de albuquerque 2002; pattulo 1996; sheller 2003 ) frequently leads to a net loss for society and prompts heightened income inequality and social exclusion over the long run (peterson et al. 2020; stiglitz 2013) . moscardo (2015) indicates that the social exclusion and the erosion of social capital stem largely from the lack of community involvement, capacity, and advocacy in tourism development, and is one of the main reasons for the growing critique of contemporary tourism, including its adverse impacts. moreover, free-market tourism policies that seek to grow the industry and increase economic returns in the short run, rarely consider the economic leakages or the adverse downstream implications for society in the long term (dodds and butler 2019) . in stretching the concept of over-tourism and underscoring the importance of institutional failures, dodds and butler (2019) conclude that a key political economic enabler of over-tourism is the mutually reinforcing attitude, or mindset, of both private and public sector stakeholders that favor short-term growth above all else, which subsequently nurtures institutional bonding and 'blindness' (hall and williams 2008) . although over-tourism is complex, the fundamental lack of tourism governance and policy prudence by public and private stakeholders, in addition to excluding civic society and local communities from tourism decisions and development, have fostered the unrestricted expansion and negative externalities of tourism growth. understanding the role of tourism institutions and institutional regimes in maintaining a certain political economic equilibrium (acemoglu & robinson 2012 ) is essential in not only understanding the evolution of over-tourism, but more importantly, fundamental to safeguarding of community well-being for strengthening the resilience of sites. consequently, this study addresses the institutional problematique of caribbean over-tourism from a historical and contemporary small island perspective. more specifically, the investigation answers the following questions within the delimited context of a caribbean site: what are the main political economic forces and institutional regimes that influence the propensity for over-tourism? how can the socio-ecological risks of over-tourism be mitigated, and community well-being be fostered for strengthening the resilience of small island tourism development? the aim of the in-depth case study is to explore the main antecedents, processes, and effects of over-tourism, and contribute to a more comprehensive and contextualized understanding of the complexity and dynamics of over-tourism within the context of a contemporary small island community in the caribbean. considering aruba's politically dependent status and the extensive tourism history in addition to its significant tourism density, intensity, and dependency, the case of aruba is examined to understand how tourism and the impacts thereof have evolved from a historical political economic perspective. aruba is a mature small island tourism economy with over 70 years of experience with tourism. from a tourism destination perspective, it is the 'one happy island' in the caribbean (aruba tourism authority 2018). today, aruba is ranked amongst the top caribbean tourism destinations (wttc 2019) and is considered one of the most trade and tourism-dependent small island economies in the caribbean, which makes it highly vulnerable to external shocks (peterson 2019) . descriptive analysis of stylized indicators shows that aruba is the most tourism-dependent economy in the caribbean (87% of gdp) and ranks second and third (after st. maarten and bermuda) on, respectively, resort density (+800 hotel rooms per km 2 ) and tourism density (+10,500 visitors per km 2 ) (unwto 2018; world bank 2018; imf 2019). the case study draws on a mixed method of qualitative and quantitative methods to examine the political economic and socio-ecological dynamics of over-tourism from a holistic small island perspective. based on an extensive historical economic survey of various social, economic, and environmental policies and indicators, the focal drivers and impacts of over-tourism are identified. case study research involves a detailed empirical inquiry that investigates a contemporary phenomenon within its real-life context. the main purpose of a case study is to provide a contextual analysis of the historical conditions and contemporary processes involved in the phenomenon under study. the embedded case studyconsisting of both quantitative and qualitative datais an appropriate research methodology in order to explore new multi-faceted concepts with limited empirical evidence (yin 2009 ). although conceptually rooted in previous studies, the political economic and socio-ecological dynamics of over-tourism remains under-theorized and under-scrutinized in empirical research, especially in nonsovereign caribbean sites. the case study combines qualitative and quantitative data analysis in a phased approached, in which the collection and analysis of quantitative economic data is followed by the collection and analysis of qualitative data in order to provide contextual richness (creswell and creswell 2018) . the validity of research findings is thus strengthened by means of triangulation of theoretical conceptualizations, qualitative data, and quantitative data. however, case study findings are regularly more geared at theory building rather than theory testing (eisenhardt 1989) . therefore, the results of this study should not be generalized beyond contemporary caribbean sites and should be interpreted from a theory development perspective. in the first qualitative phase of the study, the research focused on collecting and analyzing relevant tourism and non-tourism policy documents that were published between 1970 and 2018. both historical and national archives were consulted to retrieve a list of national policy documents and tourism plans pertaining to different areas of national development, including, the economy, society, labor markets, education, the environment, and tourism (see references for a complete list of documents sourced and analyzed). subsequently, in the spirit of grounded theoretical logic (glaser 1992 ) and using semi-structured qualitative coding and memoing, the policy documents were analyzed for types of tourism policies, aims, institutional responsibilities, recommendations, and execution. for each document, key elements were coded with reference to, e.g., specific national context, tourism environment, policy decisions, challenges, and development options. cluster-and pattern-matching techniques were applied to identify and inductively design a hierarchy of themes and sub-themes from the qualitative data and compare these with the (theoretical) antecedents and effects of over-tourism (yin 2009 ). thus, by applying qualitative data analysis, a contextualized tourism framework was inductively constructed based on major themes and historical events across time and space (see table 1 ). the quantitative survey consisted of a historical economic survey. data was collected by examining available and accessible statistical databases from national tourism and non-tourism authorities involving the central bureau of statistics, the department of labor, the department of nature and environment, the aruba tourism authority, the department of economic affairs, and the central bank of aruba. national databases and archives were surveyed to collect data on economic, tourism, labor, social, environmental, and other historical indicators tourism (see references for a complete list of documents sourced and analyzed). to identify the main antecedents and effects of over-tourism, the data was standardized across several indicators in order to normalize the data and facilitate comparative and inferential analyses. the data was standardized by using a min-max scaling method: y = (x-minx) / (maxx-minx), where x is the original value and y is the normalized value between [0, 1]. subsequently, to explore the latent (theoretical) structure of the over-tourism construct, in addition to reducing the number of individual variables and the potential multicollinearity, a principal component panel regression (pcpr) analysisa special form of partial least square regressionwas applied, in which the over-tourism construct was regressed on the newly identified components. in examining the main antecedents of over-tourism, a production-like function was applied consisting of the identified regressors, i.e., the over-tourism antecedent factors. the production function form was estimated as a log-linear relationship using: ln(y) = a0 + σailn(oti) + ε, with y = over-tourism, ot = antecedent factors, and a = coefficients. to analyze the dynamic (non-linear) effect of over-tourism, quadratic regression analysis was conducted to assess the effect of over-tourism on several socioeconomic and socio-ecological indicators. based on the parameter estimates of the quadratic regression function, the over-tourism vertexthe threshold or tipping pointwas calculated and subsequently compared to the state of over-tourism. the birth of the aruban tourism industry dates to 1930's when the first commercial airline landed on aruba and a guest house was opened in oranjestad, the capital of aruba. the official opening of the aruba caribbean hotel as the first luxury resort of aruba ushered in a new epoch in the development of tourism in the early 1960's. with the early dawning of the tourism industry, the government of aruba was keen on developing and institutionalizing a new economic pillar (besides the oil refining industry), and a national vision emerged to become 'the little miami of the caribbean', reminiscent of the vibrant economic scene in cuba during the 1950's. in 1947, the aruba tourism commission (atc) was established and, subsequently, transformed into the aruba tourism bureau (atb) in close collaboration with the local tourism industry and international partners. at the time, aruba accommodated an estimated 900 visitors and three (3) hotels of approximately 100 rooms. in february 1955, the first cruise ship with 300 visitors entered aruba's harbor. in 1965, the aruba hotel association (aha) was founded and later changed to aruba hotel and tourism association (ahata), thereby incorporating several tourism and hospitality sectors, and solidifying the foundation of the 'one happy island'. since the early days of tourism innovation, the government of aruba pursued a free-market, export oriented economic policy (undp 1996) . ever since, the island's tourism policy has been geared at attracting large and mid-scale resorts, and incentivizing international investments (e.g., tax holidays, government guarantees, special concessions, dedicated facilities) for constructing luxury, timeshare, and condominium resorts, expanding air and cruise port infrastructures, and fueling several tourism-related facilities and amenities, such as casino's and golf parks (cole 2007) . this tourism growth policy orientation still holds today with a keen focus on fostering a high-end (quality) tourism destination by attracting affluent tourism, promoting airlift and cruise calls, increasing tourism receipts, upgrading product quality, and safeguarding the aruban visitor experience (ata 2018). during the 1970's, aruba witnessed a strong expansion of international tourism, which received an extra push with the closing of the oil refinery during the late 1980s. to reinvigorate the economy, the government agency atb was tasked with opening new markets, increasing airlift, strengthening promotion, and was renamed the aruban tourism authority (ata). during this period of bolstering tourism growth, a new tourism master plan was developed with the aim of building a 'tourism corridor' (in the north-west region and capital of aruba) and improve the quality of tourism in order to increase tourism income and revenues. given the rich environmental and social endowments of the island, tourism was an almost instinctive and natural course of action, which accelerated with continued investments, growth, and expansions during the 1990's and well into the 2010's. by the early 1990's, aruba was well on its way on becoming 'little miami' and there were clear signs of an overheating economy with significant economic growth and inflationary pressures. in the 1997 article iv mission, the imf reported: "earlier growth rates, based primarily on rapid expansions of the tourism sector, had given rise to a significant population increase, surging housing demand, and incipient inflationary pressures, and a government decision to limit new construction, given nearly full employment and the island's limited physical resources". economic growth in aruba will depend on increased capacity utilization, moves to further upgrade the quality of tourism, and the diversification of the economy." (imf 1997, p. 2) consequently, there were increasing calls to halt hotel constructions and further expansions, and diversify the economy with quality tourism and other high-tech services. in its 1996 country cooperation program, the undp concluded: "…its medium term development objective is to sustain economic growth by restoring the domestic balance of savings and investment and the external balance of trade, to maintain price stability, and to diversify the economy by creating an environment that fosters private sector investment in sectors other than tourism. in collaboration with the world tourism organization, undp will conduct studies on how to improve the quality of tourism in aruba. this will include a study on the demands of high-income tourists and of aruba's comparative advantage as a destination point in the international financial and convention markets, which includes the definition of requirements for high-technology and other services." (undp 1996, p. 3) . in terms of social development and environmental resource management, the undp (1996) also indicated that more policy efforts were required for strengthening income equality, labor force participation, human resource development in order to have "the population participate more equitably in the benefits of the economic expansion of the past nine years" (undp 1996) . with reference to the environment, the undp indicated: "the predominant role of tourism and of the oil industry in the economy of aruba make imperative the careful management of natural resources based on proper environmental planning. undp will assist the government in preparing an environmental master plan, based on an assessment carried out by the united nations environment programme in february 1995. undp will assist the government in building up national capacity in physical planning and environmental management." (undp 1996, p. 4) although these plans never crystalized, several years later in 2003, the national tourism council (ntc) was institutionalized by the government of aruba and tasked with the development of a new tourism master plan for the future of aruba. accordingly, the ntc (2003): "…embodied the commitment to the industry to involve both the public and the private sectors in working together to implement strategic changes in aruba's development, and to build and maintain the island's future as a prime caribbean destination". (ntc 2003, p. 4) the ntc involved different destination stakeholders and (public and private) institutions, and identified four key tourism challenges, including (a) the sustainable development for culture, heritage, and environment, (b) quality assurance, standards, and training needs, (c) safety and security for residents and tourists, and (d) the development of a collaborative public-private sector partnership. in recognition of the rapid tourism growth after 1986 and consistent with the previous conclusions by the undp (1996) , the ntc (2003) indicated: "…the concerns expressed […] are of relatively longstanding in aruba. others have arisen in the aftermath of the threefold expansion of tourism in the late 1980s. the latter was accompanied by high levels of new immigration to the island and the accelerated growth of population, leading to urban sprawl, and increasing erosion of the island's natural landscapeprimarily adjacent to the island's tourism corridor and oranjestad. aruba already has one of the highest densities of tourism and population in the caribbean. although questions of sustainability are often relegated to 'over the horizon', the fact that the island is so small, and the pace of growth so fast, requires that long term constraintsthose that are likely to greatly impact present residents and their childrenare identified and incorporated into the framework". (ntc 2003, p. 7) void of implementation and realization, many of these ntc concerns and thoughts resonated strongly in the subsequent national plan for sustainable development 'nos aruba 2025' (in english: our aruba 2025) that was developed during the late 2000's by means of a national community-based participatory planning process. several thousands of residents of different backgrounds and affiliations were actively involved by means of an appreciative inquiry process through which aspirations and pathways for sustainable development were collaboratively designed. the national plan, however, was never adopted and largely abandoned by 2010 after the government and parliamentary elections in 2009. in 2011, the ata was privatized as an independent entity ('sui generis') and tax reforms were introduced, including the re-allocation of room tax revenues (previously government tax revenues) to finance the ata's institutional and promotional activities in developing full-fledged and self-sufficient tourism destination marketing and management organization. furthermore, the aruba tourism product fund was established to expand tourism infrastructures. in 2011, the government of aruba presented a strategic plan for the development of tourism echoing many of the sentiments presented in previous master plans: "the objective of this new plan is to maintain and improve aruba's competitive position in the caribbean in the short, medium to long term. additionally, this strategic plan will assist aruba in generating sustainable growth in the tourism sector in a socially acceptable, environmentally sound and economically viable manner. the outcome of the plan will allow the government and the private sector to make clear policy choices and commit to a development strategy for tourism, while securing and enhancing the quality of life of its citizens. the plan is needed for several reasons. while it is known that tourism will continue to play a critical role in the economy of aruba, the question lies if the current model of tourism specialization that has been used in the past will work in the future. additionally, changing demographics of tourists have strong implications in understanding the visitor experience to aruba." (government of aruba 2012, p. 11) today, the aruban economy is almost exclusively dependent on tourism as its main economic activity and income, with more than 80% of gdp generated directly and indirectly from tourism. annually, the mature and highly tourism-dependent economy generates an estimated us$ 2 billion from more than two (2) million stay-over and cruise visitors, with one of the highest tourism intensity and density ratios in the caribbean. the tourism industry employs well over one third of the workforce and is a significant source of tax revenues, surging after institutional privatization (in 2010) by an estimated 95% to well over an estimated us$ 45 million per year (cba 2019). in reflecting on the fundamental changes in travel and tourism that have transpired over the past decade, and in consultation with community stakeholders, the ata in their aruba destination development plan (2019) concludes: "these transformations, coupled with the fact that aruba's tourism product has reached a state of maturity, means it was time to reflect on what it has achieved over the past decades and look ahead to where it wants to go in the future. a small island destination greatly dependent on tourism requires a forwardthinking destination development plan. this will: • fortify its foundation to continue to thrive as a tourism destination for the years and generations to come. • help balance external factors and conserve its scarce and fragile natural resources. • safeguard the aruba way of life and happiness of its people. "the aruba hotel & tourism association advocates for controlled growth and for the government to work urgently with the private sector on a plan for the increased need for staff (which should include a well thought-through migration plan), education, the effects on all infrastructure, and healthcare, etc. committees are being formed to address these issues in time. we also need to make sure we manage where growth takes place and the location of activities and attractions, to avoid saturation of high-traffic areas. it is and should be our highest priority to ensure that the visitor experience remains enjoyable and return-worthy" (dobson 2020, p. 2). whereas 'the one happy island' brand may conjure up images of socioeconomic wellbeing, initial investigations indicate that tourism may have reached or surpassed its optimum growth. in the past, several policy notes and studies have questioned how far and fast tourism can and should expand in aruba (cole and razak 2009; government of aruba 2012; imf 1997; ntc 2003; peterson 2006; undp 1996) . more recently, studies suggest that aruba is experiencing a 'tourism exhaustion' effect (imf 2019), in which tourism growth is no longer delivering value-added with diminishing economic returns. research shows that social and ecological disparities have increased in aruba and the community is experiencing significant negative tourism impacts, including growing concerns over environmental pollution and destruction, the loss of quality of life and income equality, in addition to over-construction and crowding, which cumulatively have resulted in a growing animosity toward tourism and further tourism growth (peterson et al. 2020) . in similar vein, the government of aruba in their economic policy 'a strong and resilient economy 2019-2022' concludes: "we are at the crossroad of important decisions related to the carrying capacity of the island, to balance the need to protect the environment and to create new economic development. the expected increase in the room inventory will lead to more demand for low skilled labor and low salaries. the question remains if the internal labor market is able to absorb this extra demand for low skilled labor without the import of foreign labor. this influx of foreign labor will put extra pressure not only on the labor market, but also on the housing sector, educational system and health care. given the expected room expansion and its consequences on the livability on the island, the experience of the visitors could be negatively affected and putting at risk not only the whole tourist industry but also the economic development of aruba." (government of aruba 2019, p. 21). over the past two decades, aruba's economic growth was mainly driven by tourism and ancillary industries, including restaurant services, real estate, and construction. tourism dominates both export and import services (+80%), and foreign-direct investments are mainly driven by tourism and real-estate investments originating from north america (+65%). total visitors have doubled in less than 20 years, with tourism labor immigration and population density growing significantly by the turn of the century. the total amount of visitors per capita (tourism intensity) is currently estimated at 17 (up by 5.6 since 1995) with a tourism density of well over 10,000 visitors per km 2 . whereas the growth in stay-over visitors dominated between 1980 and 2000, total cruise visitors and the cruise intensity (cruise-to-stayover visitor ratio) have surged over the past two decades (see fig. 1 ). from an international tourism demand perspective, the segmentation of tourism (origin) markets also witnessed a marked shift over time. whereas the north american visitor market has always dominated international tourism demand (+60%), analysis indicates that since 1995, aruba experienced at least two distinct phases of relative expansion and contraction in the segmentation of international tourism markets 1 (see fig. 2 ). the results suggest that the segmentation of international tourism demand is cyclical in nature and follows global economic shifts and shocks (i.e., economic cycles, economic recessions, and economic crisis). between 1995 and 2004, international tourism market index (tmi) rose from .36 to .55higher degree of concentration -, followed by a contraction from .55 to .34lower degree of concentrationbetween 2005 and 2015. over the past five (5) years, the itmi rebounded from .37 to .57, its highest level (of international tourism demand concentration) over the past two decades. the international tourism demand cycle is largely explained by two complimentary economic forces and cycles across the north american and the latin american tourism markets (see fig. 2 ). whereas the first tourism market concentration phase was largely driven by the simultaneous expansion in the north american tourism market (+4.9%) and the contraction in the latin american tourism market (−4.3%), the second tourism market diversification phase was caused by a significant expansion in the latin american market (+17%). during this second phase, growth in the north american tourism demand contracted (−1.7%) and the european markets grew (2.7%). the recent rebound in the international tourism demand cycle was primarily driven by the collapse of the latin american market (−27.6%; venezuela in particular), and the strengthening of economic conditions in north america (+6.1%; especially in the usa). analysis indicates that while tourism market concentration is positively international journal of community well-being associated with higher tourism intensity (β = 13.24; p < .01), alternatively, the diversification of tourism markets engenders relatively less tourism intensity (β = −16.48; p < .01). the findings suggest that not only does surging international tourism demand fuel over-tourism, but more importantly, that the (geographic) segmentation and (stayover vs. cruise) nature of international tourism demand are significant forces that generate over-tourism in select caribbean sites. an unrestrictive principal component analysis with kaiser normalization and varimax rotation was conducted to identify the main constructs of over-tourism (see table 2 ). the analysis yielded five (5) components with satisfactory loadings (>.60), acceptable adequacy (kmo > .68; sphericity <0.001), and reliability (cronbach α > .70) for an exploratory case study. consistent with previous studies, the findings indicate that the status of over-tourism component incorporates tourism intensity, tourism density, and tourism dependency, reflecting the volume, concentration, and contribution of tourism, respectively. three independent constructsantecedents of over-tourismwere identified, i.e., tourism supply chain, tourism architectural style, and tourism export specialization. whereas the tourism supply chain component describes the supply chain effect of the growth in airlift, accommodations, and labor, the tourism architectural style component describes the spatial concentration and design of cruise and accommodation infrastructures in a specific geographic area or coastal zone. the tourism export specialization component describes the outward (export-led) economic orientation and tourism specialization focused on, e.g., tourism investments and expansion, export earnings and revenues, and promotion. the tourism ecological stress component consists of coastal resort stress, coastal visitor stress, and coastal pollution, and is an indirect effect of over-tourism. it describes the stressors and pressures from land-and marine-based tourism activities in (concentrated) coastal areas, which are conducive to ecological decay and coastal erosion. regression analysis was conducted on the state of over-tourism and the previously identified components (see table 3 ). a one-year over-tourism time-lag was included as a control variable. in addition, the degree of international tourism segmentation was used as a proxy indicator for the effect of international tourism demand. the results indicate that all four (4) components are significantly related to the state and development of over-tourism in aruba (adjusted r 2 = 0.90; p < .05). a positive relationship is found for tourism supply chain (β = .61; p < .01), tourism architectural style (β = .59; p < .05), and tourism export specialization (β = .15; p < .05). conversely, international tourism market segmentation is negatively associated with the state of over-tourism (β = −.51; p < .05), i.e., higher tourism market diversification is associated with less intense over-tourism. in general, the results are in line with previous studies and suggest that multiple supply and demand forces shape the propensity for over-tourism in aruba. more importantly, the results show there is an aggregate effect of interdependent domestic institutional factors that fuel the overrun of tourism. in terms of the economic contribution of tourism, the findings indicate that whereas nominal tourism service exports experienced significant growth over the past 20 years (+5.7% per year), average real tourism receipts growth diminished between 2000 and 2018 (−1.5% per year). since 2006, the price index for the domestic tourism industry surged by an estimated 45% (cbs 2019). analysis indicates that increasing levels of over-tourism between 1990 and 2018 are negatively associated with real tourism receipts per visitor (β = −1.03; adjusted r 2 = .89; p < .01). the findings show that over-tourism has a negative impact on real tourism receipts per visitor, with a tourism overshootbeyond the over-tourism vertexof +3.1 visitors (see table 4 ). although negative, the findings indicate that over-tourism has no significant bearing on real tourism receipts per capita (β = −0.10; adjusted r 2 = .07; p > .10), which decreased by 8% between 2000 and 2018. from an economic perspective, the findings suggest diminishing marginal returns from tourism specialization and growth after 2000. similarly, after experiencing a significant tourism boost during the 1990s, aruba's economy stagnated with a structural weakening of real growth (from 6.4% to 1.3%) over the past decade. the long run real economic growth is currently projected at 1.1% (cba 2019). the overdependency on tourism exports is also demonstrated by the increasing output volatility from 2.8% to 4.3% between 1990 and 2018. the results suggest that over-tourism is a significant source of rising output volatility (β = .24; adjusted r 2 = .58; p < .05). conversely, available visitor satisfaction survey data (cbs 2016a, 2016b, 2016c) reveals that over-tourism is negatively correlated with visitor satisfaction and perceived quality of tourism services. the findings suggest that visitors are increasingly dissatisfied with the destination's cleanliness (−40.8%), hospitality and friendliness (−26.5%), and local transportation (−12.6%), which may explain the decline in real tourism receipts growth and be indicative of the negative effects and tourism spillovers of environmental pollution, traffic congestion, and workforce exhaustion; on average, there are 35 visitors for every workforce employee. since the 1960s, aruba's population expanded largely due to several industrial waves of labor immigration related to, respectively, the oil refining industry and the tourism industry. it is estimated that at least 45% of the population is foreign-born, with tourism immigration remittances close to 3% of gdp (cba 2019). over the past five decades, the working age population surged with employment more than doubling and largely concentrated (+70%) in five (5) sectors: tourism services, wholesale and retail, real estate and renting, construction, and public services. however, despite labor force expansions, labor productivity and labor participation rates have deteriorated significantly over the past decade, dropping by an estimated 12 percentage points from 70% to 58% (cbs 2019). consistent with the decline in real tourism receipts per capita and real gdp per capita, labor productivity also regressed between 2000 and 2018. regression analysis indicates that over-tourism has a negative impact on labor force participation and a tourism overshoot of +2.5 beyond the over-tourism vertex (see table 3 ). analysis shows that tourism labor wages lag average median wages by at least 10% for almost a decade. income inequality as measured by the gini coefficient rose from .38 to .46 between 1995 and 2018, indicating a relative deterioration of income equality. the findings show that over-tourism has a significant impact on income inequality (β = 1.31; adjusted r 2 = .81; p < .05). real wages have remained stagnant across income distribution for over a decade, which corroborates the earlier finding on stagnant real gdp per capita growth. the level of vulnerable employment, measured by the relative poverty threshold of 60% of the median income, deteriorated between 2000 and 2018, especially in the hotel, restaurant, and construction industries (cbs 2018). moreover, an estimated 40% of households are financially overleveraged and indebted (cba 2019). regression analysis indicates that over-tourism has a negative impact on income equality and a tourism overshoot of +3.8 (see table 4 ). in confronting the increasing levels and challenges of social disparities and inequality, the government of aruba launched a special 'social crisis' program in 2019 (government of aruba 2019), yet faced challenges in financing the program due to limited fiscal space; the debt-to-gdp ratio rose from 39% to an estimated 75% between 2000 and 2018 (cba 2019). from a tourism perspective, the tourism exports-to-debt ratio is projected at 96%, which signals significant fiscal vulnerability. thus, despite significant tourism investments and growth over the past decade, fiscal space and social wellbeing have steadily deteriorated. furthermore, analysis shows that tourism growth and intensity are positively associated with government expenditures between 1995 and 2018 in aruba. the results suggest that over 50% of the surge in government expenditures over the past two decades is (indirectly) related to over-tourism (β = 1.53; adjusted r 2 = 0.58, p < .05). these cost effects ensue, however, with a time lag of at least five (5) years. thus, while the (tax revenue) benefits of tourism growth are recorded within fiscal years, the (government) expenditures of over-tourism emerge over an expanded period of time, oftentimes accumulating over generations and spanning several government cycles. in the case of aruba, negative fiscal externalities of over-tourism emerged after the turn of the century and continue to 'slow burn' an already restrained fiscal space and limiting fiscal buffers against external economic shocks and internal social vulnerabilities. furthermore, the re-allocation of room tax revenuesfrom government tax income to tourism tax incomealso weakened the fiscal budget after 2011. recent evidence suggest that over-tourism may also have an indirect long-term impact on the cost of doing business and cost of living due to relatively high levels of employers' social contribution and (core) inflation, which gradually arise from the need to recover 'hidden' fiscal costs and minimize (structural) fiscal deficits (cba 2019). with reference to aruba's tourism infrastructure, the tourism industry is largely clustered along the northwest coastline with an estimated 860 rooms per km 2 ; a significant expansion (+103%) in less than two decades (see fig. 3 ). although a small island, other geographic districts in aruba remained relatively void of (large scale) tourism-related activities and infrastructures between 1995 and 2019. the tourism industry zone was established during the late 1980's and represents an estimated 16% of the island's total geography. today, there are an estimated 14,000 accommodation units, including hotel and time share resorts in addition to condominiums, villas, and guest houses as well as (more geographically dispersed) rental apartments. whereas the expansion in hotel and time share rooms drove the surge in accommodations up until the early 2000's, over the past decade, accommodation growth was largely spurred by the construction of condominiums, guesthouses, and rental apartments (+51%), which increased the (pre-existing) infrastructural pressures and coastal resort density levels. regression analysis was conducted to assess the relationship between the state of over-tourism and tourism ecological stress. the findings show a significant curve-linear relationship between the state of over-tourism and tourism ecological stress (β = 4.74, adjusted r 2 = 0.74, p < .01). this concave relationship indicates that as the intensity and density of tourism increases, the ecological pressures grow and, more importantly, accelerate after exceeding a critical threshold. over-tourism is associated with significant ecological pressures and a tourism overshoot of +3.6 beyond the over-tourism vertex (see table 3 ). these findings suggest that over-tourism is partially responsible for the structural decay and loss of ecological services, which is currently valued at an estimated 10% of gdp. although regional zoning and marine conservation plans were adopted in 2019, aruba's natural habitats and marine environment have remained unprotected for well over 100 years since the exploitation of the phosphate, gold, and oil refining industry during the 1920's, and the subsequent construction and expansion of large scale tourism infrastructures and urbanization since the late 1970's (cbs 2016a (cbs , 2016b (cbs , 2016c . these enduring ecological pressures are also intertwined with changes in climate and nature. in terms of temperature, available evidence indicates that the sea water temperature has slowly risen over the past 60 years. it is estimated that sea water temperatures have increased with at least +1.3 c since the 1950's (cbs 2016a (cbs , 2016b (cbs , 2016c . available energy consumption records between 1981 and 2016 indicate that the effect of rising average temperatures is also reflected in the increase of average energy consumption per household (adjusted r 2 = 0.37; p < .10) and the rise in relative household energy consumption expenses from 4.8% (in 1981) to 10.8% (in 2016). despite the increasing renewable energy production (+17%), household energy consumption has also risen, which suggests that persistent household energy consumption behaviors are at play in aruba. further analysis found no significant relationship between increasing temperatures and real gdp per capita (p > .10). available data suggests that the slow burn effect of temperature rising is reflected in increasing incidences of coral bleaching along aruba's coastal reefs over the past decade. in combination with the structural deforestation and dredging of marine and coastal ecologies (i.e., coral reefs, mangroves, palm trees, etc.) since the late 1940's, the slow and consistent rise in seawater temperature is likely also responsible for the loss of marine life and marine biodiversity (cbs 2016a (cbs , 2016b (cbs , 2016c . moreover, although no significant historical data is available, the growing stress on the local marine ecosystem is also due to the incessant acidification of marine watersresulting from past oil spills and leakages, polluted water runoff, and the non-treated coastal disposal of wasteas well as the growing population density and surging coastal urbanization (cbs 2016a (cbs , 2016b (cbs , 2016c . the emission of carbon dioxide is an additional component in the rise of temperatures, energy consumption, and environmental decay. historical archives show that between 1970 and 2012, the carbon intensity rose sharply to well over 2500 million mt co 2 in aruba. this significant level and surge stemmed largely from four factors, i.e., (a) an energy supply based on fossil fuels (hfo: heavy fuel oil), (b) the operation of the oil refinery, (c) the expansion in tourism infrastructures and services, and (d) the subsequent growth of the labor force, the population, and the residential urbanization. with the closure of the oil refinery in 2012 and the push for renewable energy adoption, co 2 emissions dropped significantly (−65%) by 2016. in addition to carbon emissions, energy intensity is also a significant source of co 2 . energy intensity emanates largely from private and public service infrastructures, including residential and commercial buildings, and business and civil services. thus, beyond energy supply, energy consumption behaviors are also integral to carbon emissions. based on an analysis of two proxy indicators for energy-based co 2 emissions, i.e., real private consumption and energy consumption, the results show that similar to the rise in carbon intensity, the energy intensity increased significantly (+ 86%) in aruba. the surge in energy consumption stems largely from the growth in tourism during the 1990s and the subsequent population expansion and urbanization. this overrun of tourism growth explains at least three quarters of the surge in carbon emissions and energy intensity (β = 0.26; adjusted r 2 = 0.81; p < .05) over the past two decades. however, unlike the reduction in carbon intensity in recent years (2012) (2013) (2014) (2015) (2016) , energy intensity remained relatively stable. with reference to extreme weather events, analysis indicates that prior to the 1950s hurricanes and major tropical storms would graze the island every 75 to 80 years. over the past five decades, the time interval between extreme weather events has shortened considerably to an estimated 6 to 8 years. extreme weather events over the past 20 years coincide with major hurricanes and tropical storms in the caribbean, including e.g., joan (1988 ), bret (1993 ), lenny (1999 ), ivan (2004 ), felix (2007 ), omar (2008 ), and matthew (2016 . whereas aruba was not in the direct path of these hurricanes, the subsequent precipitation and storm surges caused significant flooding with average rainfalls of 795 mm; almost treble the annual average of 274 mm in aruba. conversely, the findings indicate the occurrence of several periods of drought after the turn of the century. in general, the results suggest an increase in climate volatility with relatively more extreme weather patternsinvolving both extreme precipitation and extreme droughtemerging over the past two decades. national census records (cbs 2016a (cbs , 2016b (cbs , 2016c indicate that over the past two decades, incidents of residential and commercial flooding have indeed increased substantially (+82%). findings from spatial data analysis show that an estimated 46% of all households are located in coastal residential areas with density levels well over 1200 residents per km 2 as well as at least 10,000 tourists per km 2 (cbs 2016a (cbs , 2016b (cbs , 2016c . these coastal areas are also prone to beach erosion due to their predominantly low elevation (<5 m) and limestone geological configuration, which is susceptible to ocean acidification, pollution, and carbon emissions. to summarize, based on the overall results of this study, the following conceptual model is proposed that captures the dynamics and flow over-tourism in terms of antecedents and effects, and their interdependencies (see fig. 4) . as an initial step towards a more comprehensive theoretical framing of over-tourism (in caribbean sites), the conceptual model consists of nine different constructs depicting (a) three (3) independent institutional drivers of over-tourism, (b) the mediating over-tourism construct, and (c) three (3) dependent impact constructs. furthermore, two (2) exogenous constructs capture the external shifts, shocks, and market demand that moderate the state of over-tourism. the extended theoretical framing of over-tourism proposes that there are several institutional forces that exert significant positive political-economic pressures on the propensity for over-tourism in a non-sovereign caribbean site, i.e., a neo-liberal outward-oriented tourism policy focused on export specialization, supply growth, and large-scale infrastructure expansion, which are largely based on private and political interests to the exclusion of societal values and community interests. the results corroborate previous studies and demonstrate the political and historical workings of several institutional failures and legacies involving, e.g., rent-seeking behaviors, market-driven interests, coercive community participation, and increasing structural deficits in regulation, regulatory enforcement, sound governance, participatory decision-making, and community empowerment. for over two decades, the systemic exclusion of the local community and the structural disregard for the destination's socio-ecological capabilities have led to significant policy drift, growing community this study addressed the political economy of over-tourism in a non-sovereign site and discussed a historical case study on the evolution and socio-ecological impacts of tourism growth in aruba. the aim of the in-depth case study was to explore the main antecedents, processes, and effects of over-tourism, and contribute to a more comprehensive and contextualized understanding of the complexity and dynamics of overtourism within the context of a contemporary small island community in the caribbean. while limited to a single case study, the findings provide an extended conceptualization and framing of over-tourism from a small island caribbean perspective, which emphasizes the political, institutional, and historical forces that shape tourism policies and development. in reviewing the overall findings of this study, the general results corroborate previous research on the adverse relationship between over-tourism, community wellbeing, and economic development. more specifically, the research demonstrates that an aggregate of political economic forces that shape and generate over-tourism over time and space. the results indicate that there are three main institutional factors that engender a state of over-tourism, which are primarily shaped by public and private sector growth-lead strategies. these institutional factors are tourism export specialization, tourism supply chain, and tourism architectural style. furthermore, the findings indicate that tourism market demand and diversification restrain the propensity for over-tourism. thus, both tourism supply and tourism demand actively influence and shape the evolution of over-tourism. more importantly, in stretching the concept of over-tourism to reflect the political economic role of tourism in a caribbean site and the subsequent institutional overpowerment of the destination communityde facto community exclusion and disempowerment in tourism decision-making and development -, the findings yield strong evidence that there is more to over-tourism than simply an over-shoot of tourism growth. essentially, over-tourism is a manifestation of coercive institutional powers and processes, and represents the social overpowerment or disempowerment of a destination community's agency. from a political-economic perspective, the results show how the institutional capture of tourism-centric values and voices, and a confluence of institutional, market, and policy failures have systematically and structurally shaped the growth and growing adversities confronting the local community in a nonsovereign caribbean site. in the specific case of aruba, the findings indicate that this 'one happy island' has faced substantial tourism policy drift since the development of the initial tourism master plan in the 1960's. despite numerous tourism policies and master plans, and the relatively consistent policy intentspanning well over five decadeson, e.g., sustainable development, quality assurance and training, safety and security, quality visitor experiences, environmental quality, social equality, and economic viability, the realization of these master plans has, nevertheless, resulted in a system of tourism specialization, supply, and style that is disconnected from society and the local community. the resulting policy ambiguity, economic disconnectedness, social inequality, and ecological degradation have engendered significant socio-ecological vulnerabilities, which have resulted in increasing community disengagement and discontent with tourism. these findings support previous studies that indicate that social inequality, ecological degradation, and economic instability are likely to coalesce. social inequality erodes community well-being and institutional trust, and engenders ecological degradation due to both environmental resource competition in addition to weakening the social foundations that underpin the requisite civic and community actions to enact and enforce environmental regulation. the resulting extractive institutions and the erosion of the socio-ecology nurtures the concentration of resources and power, thereby generating economic instability, volatility, and more fragile community development to the detriment of community well-being. although restricted to a single in-depth case with limited generalizability, the extended conceptualization and caribbean framing of over-tourism provide several avenues for future research. an investigation of multiple case studies across the caribbean, especially in sovereign and non-sovereign sites, would provide further evidence and validation for the institutional forces that shape over-tourism, and the potential adverse impacts on community well-being. likewise, it would be relevant to scrutinize these propositions from a continental, metropolitan or city perspective, particularly as the rise of over-tourism is a global phenomenon and certainly not confined to the caribbean. moreover, contingent upon sufficient reliable data, the application of econometric analysis would provide further empirical scrutiny of the proposes conceptual model and hypotheses, especially in terms of reverse causality. future research could also consider examining a possible self-reinforcing effecta positive feedback loopof over-tourism on institutional forces that generate an overtourism path dependency, i.e., rising levels of tourism intensity beget increased tourism specialization and tourism supply expansion, akin to a tourism 'lock-in' effect or 'entrapment' due to past tourism performance and success. this institutional capture stimulates tourism myopia and a short-term tourism growth orientation, which causes a gradual tourism overshoot of socio-ecological ceilings with significant costs in the medium to long term. because these costs and negative spillover effects remain relatively concealed for an extended period of timebeyond political economic cycles -, they are often not considered or disregarded in tourism governance and policies, thus setting the scene for community disenfranchisement and future disasters. acknowledging the delimitations of this study, the findings hold several policy implications for strengthening the resilience of caribbean sites in the wake of overtourism and community overpowerment. first and foremost, the findings testify to the contextual, historical, and institutional nature of over-tourism, and more importantly, to the need to address social, political, and ecological developments explicitly, extensively, and urgently in national policies and institutional arrangements, especially in nonsovereign and tourism-dependent small island economies in the caribbean. rather than simply devise buffers for absorbing shocks and bounce back to previous dependent paths of economic and social decay, fostering the resilience of caribbean sites requires building institutional capabilities to anticipate shocks, to adapt and learn, and bounce forward towards new pathways of development. there is, however, no silver bullet solution to the challenges of over-tourism. one of the biggest risks to caribbean sites is underestimating the adverse effects of over-tourism and downplaying the risks of climate change, i.e., tourism myopia compounded by willful ignorance. resolving the challenge of over-tourism requiresfirst and foremostan acknowledgement of the societal costs and moral risks associated with the uncontrolled and unregulated expansion of tourism; especially when considering the many policy studies and recommendations that have been produced and published over the past 50 years, in addition to the increasing impact of climate change. while some caribbean sites may have been able to afford some degree of policy drift and institutional inertia in the past, today climate change and related anthropogenic challenges are demanding nothing less than a fundamental rethink and redirection. echoing the sentiments of the united nations more than a decade ago, if caribbean sites countries fail to adapt, they are likely to take direct and substantial hits with detrimental repercussions for lives and livelihoods. more specifically, there is an increasingly urgent need to transition away from traditional, uncontrolled, and exploitive tourism growth fetishes towards transformative, resilient, and inclusive development. this structural transformation reflects the redesign of constricted, short-term, market-based, and elitist policies, which is based on the resourcefulness and values of a destination's community and citizens. the structural transformation describes the transition towards a community-driven development by building capabilities for innovation, internalization, and institutionalization for strengthening the resilience of small island tourism development in the caribbean (see table 5 ). pathways for innovation are primarily intended to mitigate the community and climate risks of tourism specialization, single-market supply dependencies, and expansive infrastructure and hotel construction footprints; in effect, the main drivers of overtourism (see independent constructs in fig. 4) . policy recommendations include the diversification of the economy and tourism markets, in addition to developing new community-driven and culturally-authentic niche products, experiential services, and micro-businesses. with its rich history and culture in cuisine representing well over 90 nationalities as well as an embryonic caribbean artistic scene, culture and creativity would provide a new opportunity for local entrepreneurs and the community in the specific case of aruba. likewise, wellness and health as an extension for organic foods and pristine ecology, would provide a viable avenue to explore by the community and social entrepreneurs. this would also stimulate the strengthening of domestic agri-food chains as well as the adoption of circular business models to improve resource efficiencies (for, e.g., energy, water, waste, land). likewise, reskilling of the workforce and the creation of new professional education programs would engender a knowledgebased, community-driven generation of tourism entrepreneurs, professionals, and policymakers. whereas innovation pathways are necessary, they are, however, insufficient for mitigating the socio-ecological risks of over-tourism. hereto, the costs and adverse impacts of over-tourism would need to be incorporated and 'internalized' into tourism governance and development. to complement the conventional 'outward-oriented' tourism policies and (growth) metrics, public officials and tourism authorities need to focus on 'internal-oriented' community development and commensurate (socioecological) metrics (see dependent constructs in fig. 4) . the pathways for internalization describe the explicit recognition, interrelationships, and resourcefulness of a destination's community. rather than focus solely on traditional metrics of tourism growth, internalized tourism policies integrate metrics and indicators for social equality establish and develop a national data system for the structural measurement and monitoring of environmental quality (including marine biodiversity) and social equality (including income inequality, community well-being) to inform tourism decision-making and development (see also national tourism council and national council for climate change). set up community-based and citizen-driven tourism observatories to monitor visitor behaviors and community sentiments (especially in 'tourism hotspots'). promote and establish a 'whole of government' platform to fully and transparently engage civic society, community stakeholders, public and private sector. (re-) allocate and earmark tourism tax revenues to national and community education programs. develop and implement community advocacy programs to build and strengthen awareness of tourism opportunities and vulnerabilities as well engage and empower civic society in national and regional tourism development. stimulate regional and rural community tourism cooperatives with local representatives and stakeholders to involve and engage citizens in community-driven tourism development. strengthen institutional capabilities in public-sector and tourism authorities for an inclusive and sustainable development of tourism at the regional and local level. implement environmental regulation and regulatory enforcement of coastal zone conservation and fragile habitats regeneration (spatial zoning for residential and commercial development). establish national council and policies for climate change resilience and adopt new legislation for infrastructure and building codes. incorporate climate change readiness and resilience measures in fiscal, economic, and social policies, and community programs. integrate environmental and energy measures into incentives and investment programs to reduce and recycle waste and increase resource efficiency (e.g. energy, water, land, infrastructures). labor regulation and regulatory enforcement of (minimum) wages, income equality, and labor force participation (non-informal labor). labor market flexibilization should be pursued to foster broader workforce participation and mobility, especially for young(er) professionals. regulate accommodation supply, especially of large-scale tourism infrastructures in coastal-sensitive and climate change regional zones. destination stewardship and establishment of a national tourism council with statutory mandates and inclusion of civic society, community representatives, and non-governmental organizations and environmental integrity, including the well-being of society and happiness of communities (musikanski et al. 2019; vanderweele 2019) . pathways for internalization entail the establishment and usage of a national (data) system for measuring and monitoring community well-being and environmental quality in a formal, transparent, and structured manner to enable comprehensive and evidencebased tourism policies and development. furthermore, regional, community-based, and citizen-driven tourism observatories should be developed and established to monitor visitor behaviors and community sentiments (especially in 'tourism hotspots'). this would foster community engagement and ownership as well as promote a 'whole of government' platform to fully and transparently engage civic society, community stakeholders, public and private sector. thereto, tourism tax revenues should be (re-) allocated and earmarked for national and community education programs. community advocacy programs and regional tourism cooperatives should also be considered to strengthen capacity and awareness of tourism opportunities and vulnerabilities. innovation and internalization are prone to fade and fumble if not institutionalized. mitigating the risks of over-tourism and safeguarding community wellbeing, thus, depend on the structural transformation of the localized networks of power and control; de jure and de facto. notwithstanding the most comprehensive and forward-looking tourism vision, policies, and leadership, in the absence of strong institutions and governance, sustainable development of tourism will remain ephemeral and beyond the reach of caribbean sites. whereas de jure structural reforms are necessary to strengthen the resilience of caribbean sites, they are insufficient and are likely to falter when de facto political and institutional reforms are absent. this calls for an almost paradigmatic shift in values, institutions, and governance; a transition that is unlikely to happen in the absence of any significant crisis or 'creative destruction'. while the former describes continued institutional capture and path dependency, and consequently, the strengthening of existing institutional frames, relationships, and predictable outcomes (e.g., continued construction and expansion of hotel room capacity despite a global pandemic and economic recession), the latter depicts a process of creating new pathways, restructuring institutional frameworks, fostering new and diverse relations, internalizing socioecological values, and stimulating institutional learning (e.g., establishing and enforcing climate-resilient tourism infrastructure regulations, or starting an agri-tourism cooperative in collaboration with rural farmers and providing a digital platform for tracking and tracing supply and quality). pathways for institutionalization describe structural reforms and regulatory innovations that engender ethical, transparent, and inclusive governance within the rule of law and the voice of the community. the entails the rethinking and redesigning of institutional foundations and capabilities with strong codes of ethics, competence, integrity, and ingenuity. thereto, the regulation and regulatory enforcementwith sanctionsof environmental conservation, coastal zonification, and regeneration of biodiverse habitats (e.g., coral reefs, mangrove ecologies, wetlands of endemic species) are a prime directive. spatial zonification and governance are quintessential for regulatory execution and enforcement. likewise, establishing environmental oversight and a national council for climate resilience are highly recommended to firmly and legally position matters of nature and ecology on the highest national agenda. environmental and energy measures should also be integrated into incentives and investment programs to reduce and recycle waste and increase resource efficiencies (for, e.g., energy, water, land, infrastructure, and construction). from a labor and tourism workforce perspective, flexibilization, participation, equality, and mobility should be placed on the national agenda for development. the regulatory enforcement and oversight of minimum wage payments, income equality, workforce registration, and formal labor force participation are key directives for policy execution. labor market flexibilization should be pursued to foster broader workforce participation and mobility, especially for young(er) professionals and other vulnerable groups in society. lastly, the statutory establishment of destination stewardship and a national tourism council should be pursued to safeguard community well-being to strengthen the resilience of small island tourism development. hereto, commensurate institutional capabilities need to be developed with the structural involvement and inclusion of civic society, community representatives, and non-governmental organizations. to conclude, this study underscores the contextual and dynamic nature of overtourism, and more importantly, the need to address social and ecological developments explicitly, extensively, and urgently in the policies, norms, and institutional arrangements, especially in tourism-dependent small island economies in the caribbean. rather than continue on the old path of extractive and exploitive growth, caribbean sites need to forge new pathways towards inclusive tourism development and lead from an emerging future of climate change and other geopolitical challenges. although certainly not an easy feat as witnessed by the enduring and persistent policy and market failures over the past decades, if these principles and fundamentals of sound political and public governance are not cultivated and advanced, no amount of master planning will suffice. without concerted, committed, and creative institutional actions and agency to nurture the well-being of small island societies, the existential challenges of over-tourism and climate change will endure and gradually intensify in caribbean sites. quintessential is the institutionalized involvement of the community and 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methods publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations conflict of interest the author declares no conflict of interest.ethics approval and consent to participate the research in this paper did not involve human subjects and thus no consent was required. key: cord-018332-893cckyz authors: price, jason d. title: desire and the law: creative resistance in the reluctant passenger and the heart of redness date: 2017-07-16 journal: animals and desire in south african fiction doi: 10.1007/978-3-319-56726-6_5 sha: doc_id: 18332 cord_uid: 893cckyz this chapter offers a critique of animal rights approaches for their weakness in relying on the passage of laws, and in depending upon their proper administration by legal authorities to attempt the protection of animals. where some thinkers espouse an animal rights perspective, this chapter argues that postcolonial desire is vital to protecting communities in ways that rights discourse and the law cannot in the context of the biopolitical workings of the state and globalized capitalism. drawing from deleuze and guattari’s work on desire and the law in kafka (1986), the chapter considers the potential of desire to offer creative alternatives, outside of legal discourse, toward the protection of animals and the larger community. additionally, it recognizes how indigenous environmental knowledge and notions of desire offer ways of relating to animals that can challenge capitalist instrumentalization. by zakes mda portray communities that struggle to protect themselves, their lands, and the animals with which they dwell from being used and abused to turn a profit for businesses. both novels portray competing claims for land as business proposals attempt to develop potential tourist locales by disenfranchising their current inhabitants through the rhetoric of western notions of "development." as in chap. 4, the role of desire as "eating" appears here as government officials are bribed by business owners to approve their land-development proposals, and at the cost of sacrificing the homes, protection, and interests of the local inhabitants of these lands. these stories perform what graham huggan and helen tiffin identify as " [o] ne of the central tasks of postcolonial ecocriticism" as they "contest-also provide viable alternatives to-western ideologies of development" (27) . the capitalist proposals for wealthy tourist destinations continue in a colonialist view of these lands as blank spaces awaiting appropriation and transformation into capital. this chapter explores how characters in both novels successfully work within and beyond the law to prevent the destruction of particular environments which they have come to know intimately. the protagonist of the reluctant passenger, an environmental lawyer, critiques the political scene that the novel sets up involving unethical environmental rulings and other legislation influenced by big business and bribery. heyns' novel highlights many environmental concerns, particularly the legal status, or lack thereof, of animals (specifically baboons) in south africa. as the protagonist struggles to help maintain the nature preserve for the troop of baboons at the request of his client luc tomlinson, the novel portrays luc's experiences dwelling with the baboons, demonstrating his great respect for their lives and culture. similarly, camagu, the protagonist of the heart of redness, argues against the development of the small village he has grown to love into a gambling city. offering a more ecocritical alternative to the tourist town, camagu expresses his view, informed by qukezwa's political analysis and knowledge of local culture and nature, that the town developed by outside businesses will offer little work or profit for the townspeople and be detrimental to their environment. in contrast, he proposes a smaller measure of a resort built with local materials by the villagers appealing to a different type of tourist who "like[s] to visit unspoiled places for the sole purpose of admiring the beauty of nature and watching birds without killing them" (239). these novels consider the available avenues for opposing the late capitalist thrust to transform all the world and its inhabitants into objects that are available for consumption and for turning a profit. the communities in these works offer ways of thinking about promoting sustainable futures against the overconsumption of the environment associated with most capitalist development projects. as animals are valued highly by the characters in both texts, heyns' and mda's novels argue persuasively for sustainable futures for the humans and animals (and in heart of redness also the flora) that are part of their communities. characters in both understand community in a broader sense, including humans and non-humans, and recognize that they are all potentially disposable in the logic of profit-seeking capitalists. where some approaches to the stories espouse an animal rights perspective, i argue that an ethics of sustainability and a biopolitics informed by deterritorialized or postcolonial desire, here specifically the desire for animals, is essential to protecting communities in ways that rights discourse and the law cannot guarantee. in the reluctant passenger, the protagonist, an environmental lawyer named nick morris, somewhat contradictorily dislikes the ungovernable or disorderly aspects of the environment and animals. for example, he has a discussion with his friend and fellow lawyer, gerhard, about masturbation that turns into an analysis of romantic poets where morris discloses that he masturbates to the lake district of england. in response, gerhard encourages him to consider blake's poetry and to "try the tiger next time" (173). nick explains his disregard for unruly nature: i am not a tiger type of person, and such fantasies as i have tend towards the tame. for this reason my involvement in the ever-deepening intrigue surrounding luc tomlinson's baboons was as unusual as it was unwelcome. as far as i'm concerned, the environment should behave itself if it wants us to look after its interests. as a matter of fact, the lake district is just about my notion of an ideal environment: well-mannered, contained, placidly packaged, officially protected and signposted. (173) as the novel progresses and nick becomes increasingly involved with luc tomlinson and the case for the baboons, the lawyer discover the law's limited ability to protect the animals. " [t] he rights of animals are a much debated area in law" (259) is the best that nick can offer in response to luc's query about protecting the baboons in a legal manner. where the law fails them, i'm interested here in how and why the characters work to protect the baboons extralegally. in light of nick's discomfort with "wild" or untamable nature (or zoe) and his sexual fantasies about ordered and "contained" environments, his reassessment of the unmasterable aspects of the world including his own desires and "self" leads him to break several laws in the course of rescuing the baboons with luc later in the story. where nick once lived a life of abstinence to avoid the messiness and feelings associated with a sexual relationship, he ends up having sex with luc in his house while the rescued baboons they have secured in the second floor of his house dirty, rearrange, and otherwise mess up his home, which had once been so clean and ordered as to appear uninhabited. this scene indicates the importance of a positive appraisal of desire to protect animals in relation to the limits of legal or animal rights approaches, positions which i analyze below. in the animal gaze: animal subjectivities in southern african fiction, wendy woodward reflects on the interiority and sense of "self" of the animals in southern african fiction, including the reluctant passenger and the heart of redness. for her, these literary representations of animals do important work toward changing the way we think about animals and their rights. woodward argues that animals have subjectivities, so they should be recognized in the south african constitution and be accorded rights. in support of her animal rights approach, she draws from martha nussbaum's philosophy of "moral agency," a philosophy which, as i'll discuss later, braidotti criticizes heavily early on in transpositions. for example, woodward recounts how martha c. nussbaum critiques utilitarian approaches to rights which position animals as having "moral standing." she summarizes the utilitarian position through a quotation of nussbaum: because they are subjects of social justice "if a creature has either the capacity for pleasure and pain or the capacity for movement from place to place or the capacity for emotion and affiliation or the capacity for reasoning and so forth (we might add play, tool use, and others), then the creature has moral standing" (362). nussbaum quite rightly argues for the importance of the agency of the nonhuman animal; in moral agency, then, the animal is active in this sphere, whereas "moral standing" is conferred on the nonhuman animal for the characteristics he or she embodies. (woodward 68) this preference for active instead of passive qualities in "moral agency" over standing or capacity is certainly a more interesting approach regarding the question of animal morality because agency suggests a recognition of the moral life and behaviors of animals, yet "moral agency" still suggests that animals should be granted rights because they have similar agency to that of humans. élizabeth de fontenay also critiques this position in without offending humans: a critique of animal rights: without useless brutality toward metaphysical and legal humanisms, a pathocentrist perspective does in effect allow us to establish the fact that the moral community is constituted not only by "moral agents" capable of reciprocity, apt to enter into contracts with full knowledge of what this means, but also by "moral patients," which includes certain categories of human beings and animals. (67) fontenay's argument here is that this approach to rights from the perspective of "agency" leaves out some humans and animals from being protected because they do not possess this agency. she further critiques this in her response's to peter singer's philosophy, arguing that such rights approaches are "offensive" to humans as they run the risk of sanctioning the poor treatment of non-normative humans, such as those with different mental abilities who may not necessarily be included in the category of "moral agents." posthumanist accounts of subjectivity, such as rosi braidotti's nomadic subjectivity, that involve a radical immanence, offer a fluid notion of the subject where subjects are interdependent, existing in assemblages with other humans and the non-human, instead of a fixed view of subjectivity in the liberal individual tradition. the law constructs dominant, discursive subjects which fail to do justice to or fully account for the fluidity and complexity of our subjectivities. braidotti argues: the becoming-animal axis of transformation entails the displacement of anthropocentrism and the recognition of trans-species solidarity on the basis of our being environmentally based, that is to say: embodied, embedded and in symbiosis … "life," far from being codified as the exclusive property or the unalienable right of one species-the human-over all others or of being sacralized as a pre-established given, however, is posited as process, interactive and open-ended. (99) while woodward does discuss deleuze and guattari's becoming-animal briefly at times, she looks for more human qualities or attributes of human subjectivity in the animals in the literature she analyzes, which approaches a kind of becoming-human of the animal. rights discourse, while oriented toward protecting animals from violence, ends up humanizing animals, leaving this political approach perhaps less effective than other creative options. braidotti also critiques martha nussbaum's universalism (after kant), which assumes a stable humanist subject. nussbaum's formulation seems to view animals as fixed, individual subjects who possess agency, whereas the vital materialist deleuze views both subjectivity and agency as dispersed, interdependent, and the subject as a process in assemblage. braidotti also critiques nussbaum's position for the way she tries to intimidate new or experimental approaches and philosophies by asserting that they are relativist. another problem with universalism is the failure to appreciate local knowledges and hence a tendency toward a monocultural, dominant view of the world. woodward, however, nicely avoids this by recognizing and analyzing the importance of shamanist traditions and the indigenous knowledges of south african peoples. in essence, woodward's somewhat humanist approach and the posthumanist approach i espouse are after the same goals-the protection of animals-although her project seems limited to that particular kind of life that possesses "moral agency," whereas mine seeks to protect the community in a broader sense. that is, i am concerned with the protection and improvement of the conditions and treatment of animals, the environment, and the others of man that have been excluded from man's central position in humanism and therefore viewed more easily as disposable because of the negative valuation of difference that results in racism, anthropocentrism, and phallogocentrism. while the reluctant passenger and the heart of redness offer a view of animals as deserving of rights, and the reluctant passenger engages in this discourse of rights more directly, both novels also offer more creative ways of thinking about sustainable futures. thus they call for working inside the law and also other creative ways of protecting the animals, human and non-human, of their communities. for braidotti, sustainability consists of multiplying subjectivities "not for profit" and increasing the possibilities of positive attachments. a significant part of her project entails establishing a positive view of zoe, in contrast to negative views of it espoused by agamben and others. for braidotti, the others of man-women, native others, animals, earth others, and so on-are closer to zoe, whereas man is closer to bios or discursive life (104). she explains that [w] hereas "life" or bios has been conceptualized as a discursive and political notion ever since aristotle, zoe is the non-or pre-human "outside" of the polity. it has been rendered in figurations of pejorative alterity as the "other of the living human", which means the inhuman or divine and the dead … . against this forensic turn in contemporary philosophy [agamben's association of zoe with death, for example], … [is] the need to cultivate positive political passions and ethics of affirmation. (transpositions 265) she also explains how zoe disrupts a "unitary" vision of the subject-a non-humanness at the heart of the human that flows through bodies. this sustainability perspective replaces one of rights, as she argues: "the notion of co-dependence replaces that of recognition, much as the ethics of sustainability replaces the moral philosophy of rights" (123). in contrast to a rights perspective that argues that animals be included in the community and be granted protection because of their similarity to humans under our notion of humanism and the law, this approach of co-dependence recognizes that the "human" has never been human, never existed independently, but always depends on a relation with the non-human. part of nussbaum's approach to animals also includes the argument "that animals be recognized as subjects" (13). thus woodward bases her "rights" approach to animals on their subjectivity, and therefore their being subjects in the law. cary wolfe argues that this approach to protecting animals is not sensible: i think we would all agree that an admirable desire of humanism would be to respect the standing of at least some nonhuman animals and to protect them from exploitation, cruelty, and so on. but the attempt to articulate that desire, which is an admirable one, in terms of the rights framework ends up foreclosing and undercutting that desire by reinstating a normative picture of the subject of rights that ends up being humanist and anthropocentric through and through, that ends up with a being that looks a lot like us, so that, in the end, nonhuman animals matter because they are just a diminished version of us. it seems to me self-evident that trying to think about the value of dolphins in terms of their being diminished versions of homo sapiens makes no sense. ("after animality" 186, emphasis added) for wolfe, rights approaches then inevitably begin to look for human characteristics in animals as a means of securing their protection. while his reading of the law and animal rights perspectives often focuses on the work of derrida, specifically derrida's essay "before the law" from which he derives the title of his book on biopolitics, wolfe's emphasis on the "undercutting" of desire is something worth taking up from deleuze and guattari's perspective. both derrida, and deleuze and guattari, write about kafka's the trial, which includes the story entitled "before the law," as a starting point for, or in the course of, their thinking about the law and what it means to be "before the law." wolfe spends much of his work on biopolitics describing derrida's position, noting, for example, the lack of response in law as, constructed in the technicity of language, its automatic nature leads merely to reaction. yet in this interview he emphasizes "desire" in relation to the law. as this project has explored the role of desire throughout, deleuze and guattari's writing about desire and the law, specifically their kafka: towards a minor literature, adds another fold to biopolitical thought. while he doesn't consider deleuze and guattari's writing about kafka, and therefore their specific writing about the relationship of their vitalist project to the law, wolfe does address how deleuze's work, which might seem at first to promote the equality of all life in an affirmative biopolitics, is useful in terms of biopolitical thought. he explains how a pragmatic application of deleuze's philosophy bypasses the potential problems of an affirmative biopolitics: "by a pragmatist account, philosophy for deleuze, as paul patton puts it, 'is the invention or creation of concepts, the purpose of which is not accurate representation' but rather to provide 'a form of description which is immediately practical,' one 'oriented toward the possibility of change'" (before the law 93). in other words, while their ethics of affirming zoe might appear to promote the flourishing of all life, this is not an accurate portrayal of life but instead a practical politics for resisting dominant thought, capitalist logic, and the consumption of everything that lives. desire poses a more direct and revolutionary threat-one that works outside of the rationality of the law, an authority which currently excludes most animals from the community. that is, rather than appeal to the authority or work within the confines of the law which has rendered animals in their current position, which has, through its exclusionary violence, failed to protect them, staying with that desire and its productive nature offers opportunities for working toward this protection in new ways, outside of the law. in kafka: toward a minor literature, deleuze and guattari argue more specifically against the law as a means to justice. they offer a corrective to the view that the law secures justice: "where one believed there was law, there is in fact desire and desire alone. justice is desire and not law" (kafka 49). this perspective on law agrees with wolfe's discussion of the "undercutting" of desire that pertains to rights approaches. the law, when viewed as the only outlet to protect animals, "undercuts" desire, then, by reterritorializing desire into the existing legal framework, appealing to its authority or authorities, thereby undermining its revolutionary potential. or more specifically, for deleuze and guattari, the law does not undercut desire but instead is one of two kinds of desire: the transcendental law or the schizo-law. they argue: we should emphasize the fact of these two coexistent states because we cannot say in advance, "this is a bad desire, that is a good desire." desire is a mixture, a blend, to such a degree that bureaucratic or fascist pieces are still or already caught up in revolutionary agitation. it is only in motion that we can distinguish the "diabolism" of desire and its "immanence," since one lies deep in the other. nothing preexists anything else. it is by the power of his noncritique that kafka is so dangerous. (60) in other words, for them, the law itself doesn't necessarily undercut desire, but the law perhaps is one arena where desire is either reterritorialized or takes off on a line of flight. the non-critique here gestures to the potential of desires to transform to positive ends or conversely to become violent. continuing their reading of the trial, they argue: from this point on, it is even more important to renounce the idea of a transcendence of the law. if the ultimate instances are inaccessible and cannot be represented, this occurs not as a function of an infinite hierarchy belonging to a negative theology but as a function of a contiguity of desire that causes whatever happens to happen always in the office next door … if everything, everyone is part of justice, if everyone is an auxiliary of justice … this is not because of the transcendence of the law but because of the immanence of desire. (kafka 51) this position radically calls into question nussbaum's moral universalism, or "universal rights," as it is revealed that law is just an arena of sorts for desire that springs forth from the immanence of the body. desires that are not reterritorialized, that remain schizo-law, are therefore specific to the singularities of the material assemblages "next door" and, as they privilege deterritorialized desire and schizophrenia throughout their work, schizolaw provides the possibility for political action against dominant thought and dominant constructions of desire which have resulted in the failure to protect particular members of the community. 1 what's at stake in this understanding of law as nothing but desire is the realization that a rights approach needs to be backed up by the desire to enforce it for it to work toward the protection of animals or the environment. the import of deleuze and guattari's insight into the law, however, is that the law itself is empty, is nothing but desire. in other words, and i'll discuss this further in my treatment of the novels below, if the desire to protect animals, the environment, humans, and so forth does not exist in the exercising or administration of the law, the law itself (and the passing of more laws ad infinitum, even) will surely fail to protect them and ensure their futures. if those positioned as authorities of the law are colonized by oedipus and their desires are therefore reterritorialized by capitalism, the laws themselves will not stand a chance against the disposing of these others for the accumulation of pleasure and profit by the arbiters of the law. if the law is really desire and its officials are colonized by capitalism's definition of desire as lack that must be filled through consumption and accumulation, their authority in the law enables the potential of capitalist desire to render all that lives "disposable" to their personal interests and make everything available for consumption and profit in a logic of exchange. thus it becomes all the more important to theorize desire differently and to think outside of capitalist logic which defines desire as lack, viewing desire instead as an opportunity to make ethical attachments toward sustainable futures. since what appears to be law is really desire, if we take that observation seriously, decolonizing desire or resisting its colonization toward a postcolonial desire then becomes a significant intervention into the political field as part of a project to protect the others and the environments of our communities. since capitalism bombards us with its definition of desire constantly, portrayals of what i'd like to call "postcolonial desire" in these novels offers a line of flight away from capitalist logic: a field of desire which can reorient one's sense of self and relationships to others, animals, and the environment woodward argues that animals can be focused on in literature and writing because human rights have been secured in south africa. she writes: now that human rights appear to be in place in a democratic south africa-even while much of our racialised history remains intact-writers can represent animals more expansively without engendering criticism of foregrounding animals at the expense of humans. white writers in particular may have felt constrained not to portray animals as ethical subjects when the majority of south africans were without rights. (14) to be sure, the putting in place of human rights is a significant achievement, and yet, as she seems to acknowledge here in recognizing that the "racialised history" has not changed much with the advent of rights, the securing of these rights doesn't radically alter the state of affairs or ensure the protection and improved treatment of those now granted rights. additionally, the secondary consideration of rights for animals continues to privilege the human over the animal, ensuring the continual deferment of protections for animals. similarly, calls for the addition of more kinds of right, like elke zuern's argument for the case of "socioeconomic rights' (66) as part of human rights, while certainly important in their attempt to redress economic inequality and its violence, which much current rights discourse overlooks, require their enforcement by the authorities of the law. zuern summarizes her research: south africans argue "that freedom can only be realized when civil, political, and socioeconomic rights are protected and enforced" (xii). the phrasing of this observation gets to the heart of the matter in that the passage of the rights in law, if we agree with deleuze and guattari, guarantees nothing without an accompanying schizo-desire that would desire to protect the community. to further extend these rights to animals, then, without thinking desire differently toward a postcolonial desire does little to protect them or the locations where they dwell. where the recognition of rights is important in a legal sense, poor conditions obviously still persist for many of those who are now extended rights in south africa. for example, the poor conditions for miners which led to the strikes at many mines, including the marikana platinum mine in august 2012 where several strikers were shot by the police, are evidence that the putting in place of human rights has not guaranteed the protection of south africans formerly left outside the law's protection during apartheid. deterritorializing and decolonizing desire is a necessary part of any approach to protecting the inhabitants, human and non-human, of south africa. the law "manifestly lacks balls" (260), as gerhard puts it in the reluctant passenger in his summary of luc's description of the law as a "eunuch." michelè pickover reveals evidence of this powerlessness of the law throughout animal rights in noting the complicity of the law with corporate interests. she explains how in many animal protection issues such as vivisection, factory farming, the trade in wild animals, and conservation, the government officials who oversee and make laws protecting animals are often also involved with the corporations; or indeed in many cases, such as factory farming, corporations are often left to follow the laws on their own, without any oversight. for example, she writes: "the south african government either lacks the political will or the resources to police and regulate the industry" of trophy hunting, and she notes that "[t]he truth is that trophy hunting promotes a culture of violence and guns. this is in direct opposition to the needs of south african society, which is desperately trying to free itself from its violent past" (48). she also describes how this instrumentalization of animals continues in an apartheid legacy: "wild animals were exploited to fund the apartheid war, the secret agencies, the special forces and the individuals connected to them. it is no secret that the nationalist government and its military machinery were involved in the illegal trade in ivory" (51). these obvious conflicts of interest in the form of a desire to extract a maximum profit from animal bodies and being charged with the task to protect them speaks to the many ways in which the law is compromised through its colonization by capitalist desire. as pickover's reporting on the exploitation of bodies during apartheid reveals, authorities often acknowledge or disavow the rights of others and choose to administer the law as it suits their agendas and financial interests. this problem-that the access to rights and to the protections of the law are made to depend on those administering it (perhaps best described in kafka's "before the law" with the countryman seeking access to the law from the doorkeeper)-was most obvious during the apartheid regime with the passing of laws denying the rights of black south africans. in the context of this discussion of the law being colonized by capitalist desire, perhaps the most pertinent of these laws limiting the rights of black south africans were those acts which prevented or hindered these communities from acquiring decent paying jobs, ensuring that the white community would benefit financially. in the reluctant passenger, the villainous judge conroy describes these financial benefits of apartheid to morris upon telling him of his former plan to hand over the fortune he collected from corrupt dealings as a lawyer: "you no doubt imagine yourself too morally fastidious to benefit by money derived from an evil regime. i need hardly point out that for decades every white south african to a greater or lesser degree benefited by the policies and practices of that regime" (404). heyns' and mda's novels shed light on many of these problems as they portray the corruption that informs environmental rulings: the heart of redness describes the conflict of interests of the government official deciding on the development project for qolorha by the sea; heyns' novel in particular describes the government's collusion in the abuse of baboons in vivisection. to return briefly to mda's the mother of all eating, discussed in chap. 4, it is the messenger's desire which takes off on a line of flight and threatens the power and privilege exercised by the man and his fellow government's officials, who are colonized by the reterritorialized desire of capitalism. the man's attempt to stop the messenger's revolutionary behavior, which i've referred to in chap. 2, acknowledges the way in which capitalism colonizes desire: the people don't have any leadership that will create a critical awareness in them, that will open their eyes. whenever new leadership emerges, even if it begins as honest leadership, it is swallowed by the culture of eating, and becomes one with it […] the people are doomed to … [an obvious kick, and a scream] okay, okay, i admit … it will take a very small thing to spark action in them, and to arouse them to an anger that has not been seen before. (35) the man tries to quell the messenger's revolutionary desire by attempting to convince him that his behavior and the position of the people is one of impotence, as is the case for humans in relation to the gods in oedipus. his descriptions of the people as "blind" recall the "blindspots" of plumwood's discussion of what happens as a result of the colonizing force of reason, and his observation that "honest" leadership may be colonized by the culture of eating confirms her argument about the colonization of political systems as well. after experiencing the violent kick from the messenger, however, the man acknowledges that the desire of the people is what he lives in fear of as it resists his easy management and control. indeed, it is what is threatening his life at this point in the play as the messenger refuses his bribes, and he fears that this desire has the potential to change the state of affairs, threatening to unseat and remove all the corrupt officials who "eat" the community. south african author michiel heyns, whose lost ground won him the sunday times fiction prize in 2012, has also received accolades for his translations of south african literary criticism and literature from afrikaans into english, such as marlene van niekerk's agaat. he also currently maintains a blog entitled books and dogs, where he writes often about his dog simon and dogs in literature ("michiel heyns"). heyns has written previously about the potential of affect to challenge and threaten the cool reason often exercised in the violent treatment of animals and others in his earlier novel, the children's day (2002) . his second novel, the reluctant passenger (2003), features a white south african middle-class environmental lawyer, nick morris, who takes on a case for luc tomlinson and a troop of baboons. the subjects of law, rights, and desire discussed earlier come into focus in the story as the protagonist becomes more involved in the case for the baboons. at the beginning of the novel, morris detests the unmasterable and disorderly aspects of himself and the environment. heyns' offers a critique of reason and mastery as morris is frustrated by any disorganization or things that don't adhere to the norms of human rationality or reason. for example, morris wishes he was an accountant as he originally planned, where the world is neatly divided and ordered into columns of debits and credits. he also resents his neighbor's dog, who shits on his lawn, and he chooses to live a celibate life with his girlfriend so he won't have to deal with the messiness of sex or love. in an early scene, the dog actually knocks him into a pile of shit as morris attempts to clean it up to restore cleanliness to his yard. in response, morris violently wipes the shit all over the dog's body, viewing animals in a pejorative sense as mere producers of dirt and filth. morris prefers order and is a perfect employee under capitalism, an ideal manageable subject of capitalist biopolitics, as he is never late, is apolitical, and maintains neatness and order above all else. he makes all attempts to master and control his animality through regimes of culture, and he seeks to avoid encounters with his own nonhuman life or zoe (including his desires), as well as encounters with nonhumans and the nonhuman world. in addition, his concerns for the neatness of his lawn and property cause him, rather comically, to forget to vote in the 1994 democratic elections. almost all of his life is ordered and he attempts to master or control it completely. as braidotti says of the dominant understanding of consciousness, he lives in fear of zoe: relentlessly vital, zoe is endowed with endurance and resilience … zoe carries on regardless: it is radically immanent. consciousness attempts to contain it, but actually lives in fear of it. such a life force is experienced as threatening by a mind that fears the loss of control. (nomadic subjects 110) he also lives a rather sedentary lifestyle alone in a large house in a gated community, and he seems to have little life or connection to the world outside of working, with the exception of meeting his one friend, gerhard, an openly homosexual fellow lawyer who embraces zoe by, for example, discussing his sexual encounters and desires openly, engaging in sexual acts in public, and often being late for meetings and work for love-related and other reasons. the novel centers on a case morris takes up when a kind of hippie wild-man character, who turns out to be the wealthy luc tomlinson, comes into his office asking him to take his case to protect the baboons and the private reserve where he lives with them. in animal rights in south africa, michelè pickover begins with a striking story about a baboon who worked for the railroad, and as a service animal for a disabled railway man, to counter the negative view of baboons and their limited protections in the law: in most provinces in south africa baboons are classified as vermin or 'problem animals'. taking advantage of this status, in 1999 several businessmen devised a plan to build a slaughterhouse in limpopo province to kill wild-caught baboons by electric shock and then process them into salami, polony, and tinned meat for consumption in central africa and eastern europe. baboon body parts, such as hands, teeth, and tails, would be exported to asia as aphrodisiacs. (2) the baboons in heyns' novel are classified in a similar violent, disposable status and therefore luc and nick's initial attempts to protect them through legal means are fruitless. luc's father threatens to build a resort at the reserve partly because it is a business venture and he is a capitalist, and partly because of a long family feud. where nick morris initially wants nothing to do with the case, his friend gerhard encourages him to be less reserved and to experience more of the uncertain, unpredictable, and non-normative aspects of life, like the dirty, unkempt luc and the baboons. as the novel unfolds, the protagonist learns about himself as he learns more about baboons, appraising them as a worthy case, suggesting the interconnectivity of a positive appraisal of the non-humanness of subjectivity and of the non-human world. as he embraces zoe as a positive passion, instead of a negative one which disrupts his orderly world of progress as he had before, he comes to value the complexities of the world in its open-ended becoming. he moves from being someone who fails to ever examine his own sexual feelings for the sake of order and not wanting to be inconvenienced by them, and who detests the disorder and dirt that animals bring into his life, like his neighbors' dog, to a person who finds himself having sex with his client, luc, in his home while the troop of baboons they've saved from a vivisection lab tear apart his furniture and cause havoc to the upstairs of his house. the novel's title and image on the cover, explained in the first pages, offers a suggestive description of zoe. morris describes: i once saw a man transporting his rottweiler in a shopping trolley through a no dogs allowed area: the beast was clearly well trained, and stayed put, but you could see that all it really wanted to do was chew the wheels off all the trolleys in the universe. (11) this image emphasizes the zoe of the animal and how it is maintained in consumerist culture or oedipalized for the benefits of human shoppersthe dog is thus a reluctant passenger. as braidotti writes, challenging the idea that dogs are only dirty, "[d]ogs are not only messy, but also openly sexual. they unleash a reservoir of images for sexual explicitness and even aggression, as well as unbridled freedom: they are a vehicle for zoe" (104). like the dog in morris' story, he himself is also reluctant as he somewhat hesitantly moves in the other direction from a bios-centred life to embrace zoe: at first, he is discomforted and bothered by the presence of luc and the thought of taking on the case for the baboons. as morris ends up exploring his sexual desires with luc tomlinson, he recognizes that the messiness of life which is part of his own subjectivity, or the zoe which flows through him, is connected to this non-human force of life in animals. he adopts a view of life and of the subject that correlates with ecofeminism "which asserts the fundamental interconnectedness of all life … [and which] offers an … ecological ethical theory for women and men who do not operate on the basis of a self-other disjunction" (2-3). he begins to care for the baboons, luc, and his neighbors' dog, which he formerly detested, when they plan to euthanize the dog because they are leaving for australia and no longer have a use for it, like the guard dogs in disgrace, to protect their property. the reluctant passenger reveals throughout the legal case for the baboons and through the behavior of various judges, lawyers, and government officials that the workings of the law are really the workings of desire. for example, we learn that luc desires protection of the baboons, and the protagonist, morris, begins to care for the case at first because he desires luc as the narrative later confirms. and it is gerhard's embracing of zoe and his encouraging of the protagonist to take pleasure in the world in its becoming that leads him to take on the legal case for the baboons. in other words, morris doesn't take on the case at first because he legally has to-the law doesn't require that he accept the case or that the baboons be protected, and indeed he appraises it as not much of a case at first. yet his desire, which is before thought, compels him to venture out to the preserve to meet luc and the baboons. further evidence of the law actually being desire is the revelation toward the novel's end that the authoritative figure judge conroy has been controlling most of the plot through underhanded deals, bribes, and so on-many of the same tactics that he and other judges used during the apartheid regime. having lost the woman he loved, joyce tomlinson, to the wealthy brick tomlinson, luc's father, while living a modest life to complete his law degree, conroy spends the rest of his life seeking revenge for the lack of consummation of his desire for joyce. we learn that he manipulates brick to propose the business development of the baboon's land, persuades luc to seek out legal recourse to protect the reserve, and controls many of the other events of the plot. as he tells the protagonist of his manipulations, nick queries: "so even in the capacity of puppet i was not indispensible?" (403). as conroy's actions reveal, he disposes of others consistently through his authority as judge for his own profit and to exact his private revenge. as these behaviors bear out, what appear to be the workings of the law are actually the workings of desire. another example of this occurs in the resignation of the director of nature conservation and development as he does so because he's blackmailed with the threat that his affair with his secretary will be revealed to his wife if he doesn't resign. thus the regulation of desire that pertains to the family is exploited here as capitalist desire attempts to reterritorialize the director's desire to protect the animals and environment. deleuze and guattari explain that [t] hese two coexistent states of desire are the two states of the law. on the one hand, there is the paranoiac transcendental law that never stops agitating a finite segment and making it into a completed object, crystallizing all over the place. on the other hand, there is the immanent schizo-law that functions like justice, an antilaw, a 'procedure' that will dismantle all the assemblages of the paranoiac law … to dismantle a machinic assemblage is to create and effectively take a line of escape that the becoming-animal could neither take nor create. thus the attempt to control or limit desires, to force people into dominant subjectivities and fit the world nicely into concepts or categories, becomes a paranoiac attempt to limit schizo-law. this desire to master the world is also something jane bennet challenges via adorno's critique in his "negative dialectics," where he theorizes that violent behavior results from the frustration that humans experience when the world does not fit their concepts (14). conroy's behavior and description of his motivations confirm his paranoid and narcissistic attempts to reterritorialize desire via his position as authority and arbiter of the law. especially interesting here also is that like her son luc, joyce tomlinson is closer to zoe in her embracing of desires as she often promotes luc's free-spiritedness. in contrast, conroy is colonized by oedipus, which defines his desire as lack in that his life is devoted to filling the lack created by joyce's marriage to brick, and to a lesser extent his desire to acquire wealth for the manipulation of others. conroy acquires wealth mostly for the purpose of attempting to separate joyce and brick. joyce, however, largely disregard's capitalism's lure as it seems she loves brick for himself, not for his finances. of course, brick's extreme adoption of capitalist logic leads him to view the baboons and their land as an opportunity for profit, and, anticipating this behavior, conroy manipulates him into the business venture. the novel thus points to the precarious biopolitical situation for those seeking protection from the law when its arbiters are colonized by capitalist desire. in other words, conroy's lack of joyce in his life and his use of his position to accumulate wealth jeopardizes the protection and futures of south african communities, making "disposable" those his position was created to protect. the desires of luc, morris, and the other characters who assemble to save the baboons, however, work to challenge these capitalist and narcissistic desires outside of the limitations of the law. as the novel reveals towards the end, conroy occupies a god-like position in his manipulation of the plot. his desire for mastery suggests an extreme form of the kind of control and disgust for vagueness and untidiness that the protagonist exhibited earlier in the novel. as the protagonist and conroy approach a relationship of mentor and mentee, heyns positions the development of the protagonist's character as dependent on his relationship to desire or zoe. at one end of the spectrum, the side of transcendental law, sits conroy, whereas nick's best friend and fellow lawyer, gerhard, embodies "immanent schizo-law" or desire and zoe as positive. conroy describes his frustration with the failure of his plan, that even after rendering brick to a state of poverty he still has not separated joyce from brick, blaming this on the incalculable nature of humans: "[a]gain i failed to take into account the inconsistency of human beings. joyce … was moved by his destitution to side with him" (404). joyce's exceeding the mastery of conroy's control suggests the ungovernability of foucault's homo oeconomicus from the birth of biopolitics, as cary wolfe describes: in opposition to what foucault calls homo juridicus (or homo legalis)the subject of law, rights, and sovereignty-we find in this new subject, homo oeconomicus, "an essentially and unconditionally irreducible element against any possible government," a "zone that is definitively inaccessible to any government action," "an atom of freedom in the face of all the conditions, undertakings, legislation, and prohibitions of a possible government." "the subject of interest," foucault writes, thus "constantly overflows the subject of right. he is therefore irreducible to the subject of right. he is not absorbed by him." (before the law 23) conroy thought he could control her, assuming that she loved her husband for his money, that she was colonized by capitalist desire, but she desires her husband for himself. even from his position of authority in the law, conroy cannot master joyce's desire or tame it to direct it toward himself. the protagonist, morris, also presents challenges to power and government that pertain to foucault's homo oeconomicus as he has broken numerous laws and no longer attempts to master his own desires. in addition, conroy offers in this scene his desire for an oedipal relation to the protagonist based on their similar orderliness and strict discipline: as you know, i had been taken with your dissertation some years ago … and now, i thought … you could take the place of the son i never had … you reminded me of myself at your age: ascetic, high-principled, civilised … for the first time my sterile obsession with avenging myself on the world for what i had missed yielded to a vision of what i might yet have. (404) here, conroy's knowledge of the protagonist's homosexual act with luc upsets his oedipal ambitions of fatherhood. more specifically, morris' acting on his sexual desires with luc caused him to miss his appointment with conroy-the first time the protagonist ever missed or was late for an appointment-frustrating conroy's ambitions of mastery. frida beckman's discussion of homosexuality in deleuze's thought acknowledges how in addition to non-human sexuality, "[a]nother way of exploding the anthropomorphic, heterosexual, familial, and oedipal organisations of sexuality is found in homosexuality" (16). she continues explaining that "[h]omosexuality, as verena andermatt conley notes, is seen here not as an identity, but as a becoming" (16). morris' now positive appraisal of desire, which also motivates his protection of the baboons (who express sexual desire themselves), therefore enables the freedom from conroy's complete mastery of most of the characters in the novel from his position as an authority of the law. morris embraces his homosexual desires, instead of repressing or avoiding desire as he does at the beginning of the novel, in a way that enables a becoming away from the fixed identity of the subject of rights or the subject of capitalism that conroy might have otherwise mastered. conroy's description of his ideal new society built on "wisdom of authority" also includes biopower in the form of "death squads" (404), biopower being that which foucault argues derives from a desire to govern and control homo oeconomicus. indeed, conroy describes his position of mastery here in a way that confirms his paranoid attempts to maintain and control desire. after suggesting that he wasn't trying to get joyce back, he comments: what i resolved to do was to achieve mastery over myself and others, partly through self-control, partly through control of them. and whereas control of the self is a matter of discipline, control of others is a matter of money. of this, as i have remarked, i soon had large sums, thanks to my contacts in countries officially hostile to south africa. (401) here, conroy confirms the manipulation of his position of authority to exact his revenge, and along the way treating others, the land, and indeed the country of south africa as disposable in service to exercising his personal grievances. in short, he adopts a relation to others of "eating," as discussed in chap. 4. while early on in the novel the protagonist, like conroy, attempts to live an exceedingly controlled and ordered lifestyle (and this is in large part why conroy views him as an ideal candidate for his mentorship), his embracing of zoe, perhaps especially his embracing of his homosexual desire, frustrates the mastery and control of conroy's plan. the protagonist's decision to embrace zoe as positive then becomes revolutionary as it creates a line of escape from the mastery and instrumentalization of the humans, animals, and environment of south africa exhibited in the apartheid regime's practices. baboons before the law at one point in heyns' novel, after the baboons have been stolen from their home, luc tomlinson appears at morris' office to discuss the legal case for saving the baboons and their land from his father's business plans to set up a luxury resort there at cape point. the conversation that the characters engage in about the legal status of the baboons reveals the problems that the law has in deciding on the status of animals, an issue fontenay discusses in her chapter entitled "between possessions and persons." luc expresses his desire to get a "court order" (259) for the baboon,s to which morris responds: "before i can get a court order i need to establish that somebody's rights are being infringed" (259). luc argues that it is obvious that the "chacs'" (chacma baboons') rights aren't being respected, noting how they've been taken away for medical testing and vivisection, an issue i'll return to later. the protagonist replies: "the rights of animals are a much debated area in law" (259). at this, luc replies angrily at morris: "i'm not interested in any fucking debate. anybody who isn't unbelievably stupid or dishonest knows what we're doing to the animals … it just suits us to come up with debates. the law is … ." morris attempts to finish luc's sentence, offering "an ass?", to which luc replies: "i was thinking of something more useless, like a … a eunuch" (259). their conversation about the law continues, describing how the law protects only certain people through their metaphor of eunuchs as morris remarks, "they guard the sultan's harem," and luc replies: "yeah. great if you're the sultan, not so great if you're not" (259). the discussion of the law in terms of eunuchs and harems continues to develop the theme of sexuality in the novel, and also points to the exclusionary nature of the law, as it only protects those who are considered as belonging to the community. the discussion of the harem and the sultan also perhaps highlights the discriminatory nature of the law's privileging some and excluding others. the protagonist attempts to end the conversation about the law and what can be done for the stolen baboons in a way that suggests he's exhausted all available avenues to help them. he remarks: "well … for better or for worse, the law, for all its shortcomings, is all we have to help us here" (259). such a position, that we can only work within legal discourse to improve the state of affairs for animals, greatly limits the political potential for addressing the problems facing them. as wendy brown and janet halley suggest, "rights cannot be fully saturated with the aims that animate their deployment … they retain a certain formality and emptiness which allow them to be deployed and redeployed by different political contestants" (9). in this sense, the affect and enthusiasm for protecting gets cut short when rights are viewed as the only avenue of intervention. brown and halley further explain the potential of critical theory for considering opportunities for politics and justice outside of legalistic frameworks, which the characters in reluctant passenger eventually take up in seeking extralegal, creative approaches: "[c]ritique [in contrast to legalism] hazards the opening of new modalities of thought and political possibility" (28). where the protagonist, who lives most of his life according to society's normative rules, who lives extremely discursively or "by the book" as it were, seems to be giving up on the case for the baboons when they reach a dead end legally, his friend gerhard intervenes, responding to morris' claim that the law is all we have: "not necessarily" (259). gerhard continues critiquing the lack of power that pertains to the law: "but where, as mr. tomlinson has pointed out, the law so manifestly lacks balls, we may have to rely on our own … devices for a remedy" (260). the characters' desires for one another-gerhard is sexually attracted to luc, flirting with him, and, as the consummation of luc and morris' relationship bears out later, they desire each other as well-and for the baboons, especially luc's, result in their hatching a plan to save the baboons, outside the parameters of the law. as a lawyer for luc and the baboons, morris employs some blackmailing of his own to win the case for the baboons and the preserved land, with the help of a fellow lawyer and her husband, and the rest of the group which have rallied round the cause, including gerhard, morris' former girlfriend, and others. as a result they are able also to reinstate mr. haartshorn, the original director of nature conservation and development, who testified in the case that he was blackmailed with evidence of his extramarital affair and bribed into resigning after writing a report denying brick tomlinson's business proposal for the land under question. morris and his team also use some compromising pictures of minister stanford from what are revealed to be sex parties for ministers during the apartheid regime, which involved their raping of young men in military uniforms at a building in rocklands, the preserve of the baboons (163). the photos were given to morris by joyce tomlinson, and later we learn, at the recommendation of judge conroy, to influence the minister's testimony so that he confesses that haartshorn gave him the report denying development prior to resigning. the trial results in haartshorn unseating the man who, in the old regime's pocket, replaced him and approved the proposal. for conroy, this is a victory because it caused a large financial loss for brick tomlinson by preventing the development of the land. however, the baboons are still rendered unprotected after the ruling as they are stolen and taken to the vivisection laboratory, and bulldozers appear at the nature preserve. thus even the legal ruling that uncovers the corruption and decides in favor of the baboons cannot protect them from the extralegal means of the capitalist desire to dispose of and turn a profit from them and their land. heyns portrays in morris a character who transforms his negative feelings about sexuality and animality into positive passions to work for the protection of the baboons, even outside the realm of the law. how do we think outside of dominant thought and beyond its closures? when faced with the limits of law, the characters' desires compel them to think differently. braidotti explains that deleuze and irigaray bank on the affective as a force capable of freeing us from hegemonic habits of thinking. affectivity in this scheme stands for the preconscious and the prediscursive: desire is not only unconscious but remains nonthought at the very heart of our thought because it is what sustains the very activity of thinking. our desires are that which evades us, in the very act of propelling us forth. (nomadic subjects 40) thus desire and affectivity enable gerhard, luc, and nick to think differently, outside the parameters of the law, to devise a plan to protect the baboons. woodward argues about luc's appeals for the rights of baboons throughout the narrative that "luc coaxes the reader to accept the concept of baboons as 'creature[s] … of moral standing' within modernity, to refer back to nussbaum's argument" (78). she further concludes her chapter on baboons by noting that "the moral agency of baboons … has not been acknowledged by the south african constitution, which does not incorporate the subjectivity or even sentience of nonhuman animals" (90). while heyns' novel certainly points to the lack of legal status for baboons, the reluctant passenger in my view more strongly argues that it is necessary to think beyond the law, and acknowledges the role that desire can play in this thinking differently. that is, by acting on their desires for the baboons' protection, and for nick morris by embracing zoe as positive instead of attempting to master it in a negative relation, these characters ensure the protection of the baboons that the law cannot always guarantee. as talal asad argues in "what do human rights do? an anthropological inquiry," rights do not always guarantee the protections they describe. he argues: human rights discourse may not … always be the best way (and it is certainly not the only way) to help remove oppression and relieve suffering among human animals, as well as non-human animals, or to preserve the world's natural and cultural inheritance. working in hospices, providing comfort for the traumatized, the sick, the destitute, helping to rejuvenate depressed neighborhoods, are among the activities that help to relieve human suffering. such commitments remain outside the imperative of the law. (51) in light of heyns' novel, we might add rescuing baboons from vivisection and hiding them in one's house to asad's list of the ways we can protect and prevent the suffering of non-human animals. although the reluctant passenger focuses on the life of an environmental lawyer, it emphasizes that we have creative options for responding to animals outside of legal means, options that exist "outside the imperative of the law" (asad) . as i've discussed in previous chapters, desire works across species boundaries, and again in the reluctant passenger an animal's desire and a human's desire for animals leads to the protection of the animals and their habitat. after nick and the adonis-like luc tomlinson walk naked with no deodorant on to meet the baboons (so as not to scare them off), petrus, the alpha male chacma baboon, takes a sexual interest in the protagonist: "'bloody amazing,' said luc, almost admiringly. 'you must have really potent pheromones.' he added with an unconvincing affectation of concern, 'i'm afraid he wants to fuck you.'" (84). as his attentions turn to another baboon, petrus does not consummate the sexual exchange in what would surely be his domination of morris, who fears petrus' great strength and doesn't want to engage in sex with a non-human animal, but the sexual arousal that the protagonist and his pheromones caused in petrus turns out to be the reason that luc, the self-proclaimed friend of the baboons, initially finds the protagonist attractive sexually as well. the passage in heyns' novel suggests the transversal nature of desire as it works across species and indicates the role that pheromones might play in sexual attraction. like the desires that involve lahnee o, minke, and corsicana in tanuki ichiban, and the whale caller and sharisha in the whale caller, here again animals' desire and humans' desire for animals ensures the protection of the animals. the desire that arises out of assemblages (and not transcendental law) enables justice: "transcendent and reified, seized by symbolical or allegorical exegeses, it [the abstract machine] opposes the real assemblages that are worth nothing except in themselves and that operate in an unlimited field of immanence-a field of justice as against the construction of the law" (deleuze and guattari 87) . thus the law is not the house of justice; instead, justice dwells in the potential of desire that results from the immanence of our bodies and relations to others in assemblage. of importance here is that this assemblage includes "black" south africans as well in the figure of nick's colleague and her husband mhlobo, who works at the mail & guardian and who supports the case for the baboons as he helps to discover the underhanded deals of the government officials. this environmentalism of the novel is therefore not a "white" or colonial conservationism but a postcolonial ecocriticism that benefits the larger community of south africa. heyns' novel portrays how the desires of an assemblage of human and non-human actors works against the mastery and control of dominant logics-a postcolonial desire that presents lines of flight out of the paranoid and narcissistic managements of the law and against the "eating" or instrumentalization of the community. gerhard's plan to retrieve the baboons from the vivisection ward demonstrates the creative potential of desire to work for the protection of others beyond the realm of the law. the group learns that the evil former apartheid government scientist now turned scientist for a corporate interest, colonel and doctor johanna van der merwe, performs vivisection on the baboons and also has a project of "rehabilitating" homosexuals to heterosexuality. pickover also highlights the horrifying fact that this testing on animals was done often to develop drugs and chemical weapons to dispose of and control those humans who opposed the apartheid government, and woodward notes this from pickover's work as well. pickover explains that this information came out in the trc hearings as she quotes dumisa ntsebesa who chaired them: when animals are being used by scientists for experiments to manufacture chemical and biological weapons, then society should condemn such experimentation in the strongest terms … even more alarming is the fact that the people who were using their research skills and knowledge to manufacture murder weapons, were people in white coats with stethoscopes hanging out of their pockets. these people are normally associated with preservation of life. that is the most repulsive feature of the evidence that has come before us. (133) ntsebeza's response to learning of the vivisection and the creation of weapons to destroy humans speaks to the biopolitics involved in this case as he notes that those who are supposed to aid in maintaining life end up being the administrators of death. in response to van der merwe's two projects, which render animals and non-dominant sexual desires (which upset her normative visions of the human and white nationalism) disposable to the control and mastery of science for the profit or benefit of the corporation and a particular vision of the nation-state, gerhard devises a plan to distract her by offering himself up as a victim for her experiments so that the other members of the assemblage might sneak into steal the baboons away. in offering his body, gerhard renders himself vulnerable and lets himself be "eaten" by the state, sacrificing his body in exchange for the protection of the baboons. gerhard explains that van der merwe "was a medical officer in the south african defence force" and during that time she "was in charge of some highly controversial experiments" (268). after mhlobo informs nick about van der merwe's horrifying science experiments, and creation of drugs and weapons to harm the black community, nick meets van der merwe, dubbed "the black widow," in a gay bar to set up the appointment where gerhard will be "rehabilitated." van der merwe expresses her views on sexuality here in a way that confirms her attempts to limit desire and to exercise biopolitical control over the south african population: "[i]n terms of all three of these paradigms [science, her womanhood, and christianity] the function of the human species is to procreate itself responsibly" (288). she continues offering here a speciesist perspective: "i believe, of course, that as the bible tells us, we have been instructed and empowered to rule over creation. the human being is the crown of creation, and as such is entitled to use the rest of creation for his benefit-within certain limits, of course" (289). such a view of animals confirms religion's role in attempting to separate humans and animals, something i've also discussed as it is portrayed in the whale caller. van der merwe continues to explain her convoluted arguments, at times insisting on the "naturality" of her positions while at other points explaining the need for science to correct nature after the fall of man. immediately prior to nick's meeting with the black widow, mhlobo informed him that one of the scientist's projects was to sneak birth control into foods that black south africans commonly eat as a way to control their populations. here van der merwe explains her position after nick queries: "isn't breeding natural?" (290). she replies: it's natural only in the sense that the procreation of rabbits and chickens is natural. nature in that sense is an accident, without plan or purpose. that is the creation over which the lord gave us dominion. the higher nature is guided by divine wisdom as manifested through science and technology, and informed by a sense of individual and national identity. here van der merwe clearly dehumanizes black south africans given that her eugenic project to control the population's sexual reproduction is discussed in terms of rabbits and chickens in this case, and she thereby establishes a hierarchy where whites are superior to black south africans. as the conversation turns to her project of making gay men straight, she explains that she takes it as her calling "to tell them what they should be, and to help them assume their rightful identities" (291). such a perspective demonstrates an attempt to control desire and subjectivity, limiting sexuality to only normative and procreative practices that might benefit the state in a fantasy of white nationalism. thus human and animal sexualities-these desires-threaten her biopolitical ambitions and ideal vision of the nation. as it turns out, van der merwe, in a sense, rapes gerhard "in the interests of science and the nation" by using a probe on him that was used to give baboons erections to extract their semen for use in experiments to develop birth control for the black population. gerhard's risking of his life, body, and perhaps sexual orientation for the baboons demonstrates a personal sacrifice that results from his desire for their protection. we learn later that the "reorientation" is unsuccessful as he admits having sex with his lover, clive, directly after the experiment, and perhaps gerhard is not as distressed from the experience with the black widow as one might assume as he seems to view it as a challenge. as the assemblage of people risk their lives and wellbeing for the baboons, it's clear that they've gone well beyond the law to ensure the animals' protection. in addition, nick's development of character emphasizes the novel's perspective that embracing zoe and desire as positive is a necessary intervention toward the protection of communities. no longer the solitary, sedentary, order-loving, manageable subject of complicit consumerism and model capitalist laborer, morris becomes political. he deals with the complexities and ungovernable aspects of life, including his sexuality, and multiplies his attachments around a common goal of a sustainable future, not just for the environment and baboons, but also toward social reforms of the legal system through removing those "eaters" of the country from their positions of authority in the government-sustainable futures for the social conditions of south africa. like morris and the assemblage of characters who work against the business proposal to "develop" the land and remove the baboons from their home in the reluctant passenger, camagu, the outsider to the village of qolorha-by-sea and protagonist of zakes mda's the heart of redness (2000), works to protect the community and environment of the village. mda also won the sunday times fiction prize for this novel, which describes how camagu and many of the other villagers, especially qukezwa, argue against the gambling city that is proposed to develop the small village he has recently made his home and come to love. offering a more sustainable alternative to the tourist town, camagu expresses his opinion, which he learns from qukezwa, that the town developed by outside businesses will offer little work or profit for the townspeople and be detrimental to their environment. as in the reluctant passenger, the association of big business with the law is revealed as the developers' attempt to intimidate the villagers' opposition with claims of their connections to the government: "how will you stop us? the government has already approved this project. i belong to the ruling party. many important people in the ruling party are directors of this company" (201). here we see another instance of the political systems that might check the instrumentalization of a community failing as a result of their compromised positions and colonization by a capitalist logic of desire. the audacity with which the developers assert their power demonstrates their impunity as they abuse their positions of authority and elite status in administrating the law: they do not seek to protect the people and animals of the village as the law might happen to prescribe. instead, the developers use their position of power to secure their personal wealth at the expense of the well-being of the community, continuing a practice of "eating" of the community in viewing it as disposable for their personal gains. somewhat similar to the reluctant passenger, where the character development of the protagonist is situated on a scale of zoe-between his embracing its uncertainties in the example of gerhard and controlling or mastering it in the example of conroy-camagu's character in the heart of redness also develops in relation to desire. in this case, how he apprehends it as oedipal, capitalist and as a lack or as positive, productive, and ethical is manifested through his thinking about his relationships with women and the environment: whether he sees the casino development's potential violence to the environment as totally beneficial to the community and views women as existing for his sexual pleasure, or by contrast, taking a more critical position, considers other more positive ways of relating to women and the environment. his interest in relationships with two women of the village indicate his growth as a character as he is at first interested in bhonco's daughter, xoliswa ximiya: a teacher who no longer lives in the village, fetishizes the us, deplores local traditions, such as the practice of dyeing the face with ochre ("the redness" of the novel's title), and sees the advancement of the community toward a greater likeness of western civilization as worth the sacrifice of the environment and animals of the village. as the novel progresses, camagu finds that he more strongly desires qukezwa, daughter of zim, who demonstrates an exceptional knowledge of and intimacy with the environment, the flora and fauna of the village, and local history and traditions. particularly important here as well is the believers' expanded notion of community beyond the "human" that is evidenced in particular characters' devotions to their horses, camagu's refusal to kill the snake of his totem that appears in his bedroom, and especially zim's love of and communication with weaverbirds. in contrast to the developers' plan, and based on the insight into "development" he learns from qukezwa, camagu proposes a smaller measure of a resort built with local materials by the villagers appealing to a different type of tourist who appreciates nature, but not for trophyhunting purposes. camagu's alternative proposal, importantly, does not disregard the fact that the villagers' lives would benefit from some increase in funds. that is, as i discussed in chap. 3 by quoting huggan and tiffin (20), he is not against "development" in and of itself. instead, he is against those forms of development that position the developers in a parasitic relation to the environments and communities they develop, where they can better control and manipulate the community through their inclusion into the global capital system. his proposal is certainly one of development as well. the important difference is that the proposal is developed so as to benefit the community as it values local flora and fauna, knowledge, and labor, rather than devastating it as the capitalist casino and theme park certainly would. the villagers of qolorha are largely divided into two groups: believers and unbelievers. the believers are descendants of the followers of the prophetess nongqawuse back in the times of the cattle-killing movement in the 1850s. 2 as the novel jumps back and forth from the colonial past to the present, at times seamlessly, colonial and neocolonial themes are developed in relation to the environment and sustainability. the believers are more traditional in their return to and appraisal of customs of the past and, as espoused by zim, a prominent believer, they are against the development of the tourist casino. however to be sure, mda does not portray these two groups as totally at odds or pure in their difference: the groups are more complex because some of the unbelievers value the traditions of others and have a mode of believing in unbelief, for example. these divisions along lines of belief, which were exploited by the british colonizers in a divideand-conquer strategy, offer a critique of the present political divisiveness that becomes a distraction and more about self-interest and pride than working toward a sustainable future and protections for the community. the heart of redness emphasizes the variety of temporalities and historical influences experienced in the present of south africa. as mbembe explains, "everything happening today is [not] simply a rerun of a scenario …. [t]oday's shift … is … toward the underground channels" (73). indeed, we've seen this underground market of animal trafficking in tanuki ichiban in chap. 4. in this sense, while i've gestured throughout the project to how the "new" south africa continues to be similar to the past violent organizations of society, mbembe makes clear that the new negative modes of relation and extraction are somewhat different in adopting this underground fashion. mbembe continues to explain how, [i] n this intermeshing of temporalities, several processes co-exist; there are processes tending to make peoples view the world in increasingly like ways, and at the same time, processes producing differences and diversities. in short, contradictory dynamics are at work …; it is too easy to reduce these dynamics to simple antagonism between internal and external forces. (73) this suggestion to avoid oversimplifying the more complex and nuanced interactions of the present organization of society is particularly useful for assessing the dynamics and influences at work in mda's novel: his observation that different, diverse perspectives are occurring, as well suggesting ways out of the culture of sameness and the status quo. as i've been describing how characters seek extralegal means to protect their communities, the heart of redness aligns with mbembe's conclusion about the dynamics of the current moment where the state is no longer viewed as "the best instrument "for ensuring the protection and safety of individuals, for creating the legal conditions for the extension of political rights" (73). the leading unbeliever, bhonco, and his daughter view all signs of "development" and "progress" imposed by corporations as beneficial for the future of the village. as evidence of this, bhonco discontinues some of the adornments of his traditional clothing and begins wearing business-style suits. as braidotti describes, late capitalism endangers not only biodiversity but also human and cultural diversity: [disregard for biodiversity] also threatens cultural diversity by depleting the capital of human knowledge through the devalorization of local knowledge systems and world-views. on top of legitimating theft, these practices also devalue indigenous forms of knowledge, cultural and legal systems. eurocentric models of scientific rationality and technological development damage human diversity. the plans to make the village of qolorha by the sea into a casino would not only render the environment unsustainable but also dominate the culture and non-dominant, indigenous knowledge, such as the ways of fishing and other environmental lessons that the american-educated camagu is continually learning from the villagers throughout the novel. alongside this are the high esteem that bhonco's daughter holds for the us, the country where camagu got a degree, only to return for the elections of 1994. camagu attempts to correct this view of the us as a land of progress by describing the prevalent racism and imperialist practices that he experienced in everyday american life and foreign policy. in his essay on the heart of redness, byron caminero-santangelo argues that the novel positions "cosmopolitan bioregionalism" as a mode of resistance to western development: if capitalism in its various phases has made space out of place, stripping away prior signification (deterritorializing) and reshaping in order to facilitate control and exploitation, then the process of imagining or reimagining a "place" entailed by bioregionalism can be one means of countering threats of exploitation, environmental degradation, and disempowerment. such a concept perhaps resonates with the idea of "smooth space" discussed earlier as a resistance to striated or mapped-out and managed space of the state. yet bioregionalism seems to offer a more specific, intimate knowledge of place and may therefore be a concept better suited to resisting the neocolonial power enacted against particular people, flora, and fauna. its cosmopolitanism challenges the isolationism or "ecoparochialism," to use nixon's term, of some bioregionalisms that adopt a view of place as separate from a broader world, or that ignore the historical and other conditions that are involved in the composition of place as a "process" (296). this cosmopolitanism is especially important in a south african context as it takes note of larger world processes, upsetting particular nationalist imaginaries and their rhetorics of purity that might attempt to deny or elide past violences, histories, occupations of land, and so forth, such as afrikaner white nationalism in south africa. as caminero-santangelo argues, "[n]otions of purity are debunked in the heart of redness not only in respect to identity and culture, but also in terms of the category of nature" (297). a cosmopolitan bioregionalist perspective makes clear how particular rhetorics of purity deployed to claim a place as home or to determine the limits of community are undermined by a broader view of international movements, material processes, relations, and so on. marisol de la cadena's concept of "indigenous cosmopolitics" presents perhaps an even more apt concept for considering the notions of politics at play in the heart of redness, given the emphasis on indigenous knowledge throughout the novel. much of her writing in her essay about differing worlds and worldviews concerning the prospect of a mining development and its potential devastation of a mountain called ausangate in the andes parallels the varied logics and arguments about development in qolorha in mda's novel. for example, bhonco shows disdain for many traditional practices and knowledges privileging western development, while qukezwa and her father zim have intimate relationships with non-human animals, and great respect for the environment and the indigenous knowledge of the xhosa. like caminero-santangelo's reading, which emphasizes the open-endedness of the novel, its privileging of continued dialogue and its refusal to uphold any one character's or group's-believers and unbelieversperspective as the truth or right view, de la cadena emphasizes plural perspectives on nature and politics rather than the one universalizing understanding that often elides other ways of knowing. she argues that despite indigenous knowledge that conceives of the "earth-being" (or mountain in non-indigenous parlance) called ausangate as significantly agentive, there are no guarantees that this knowledge will determine the decision people arrive at regarding the question of development: pluriversal politics add a dimension of conflict and they do not have guarantees-ideological or ethnic (cf. hall 1996) . people-indigenous or not, and perhaps ethnically unlabeled-could side with the mine, choosing jobs and money over ausangate, either because they doubt or even publicly deny its being a willful mountain, or because they are willing to risk its ire for a different living. ausangate's willfulness could be defeated in the political process-some would embrace it, others would not-but its being other than a mountain would not be silently denied anymore for a pluriversal politics would be able to recognize the conflict as emerging among partially connected worlds. and although i would not be able to translate myself into nazario's ontology, nor know with him that ausangate's ire is dangerous, i would side with him because i want what he wants, to be considered on a par with the rest, to denounce the abandonment the state has relegated people like him … to denounce the mining ventures that do not care about local life. (362) de la cadena, while situated outside of the world of indigenous knowledge, nonetheless promotes respect for it as she recognizes its potential-in the threat of agency from ausangate's ire-to challenge the instrumentalist views of nature offered by western biopolitics and development rhetoric. the heart of redness offers a similar perspective on "earth-being's" agency through indigenous knowledge that bhonco and other developers often elide or dismiss as backwards. for example, the qukezwa who married twin in the past explains that "we never kill the snake of the spring. if we did, the spring would dry out" (22). later, in the present of the novel, her namesake tells camagu about the agency of a specific snake, gqoloma, who lives in the prophet nongqawuse's pool: "when it pays a visit … moving from the pool at the gxarha river to another pool at the qolorha river … it causes havoc in its wake, like a tornado. it destroys houses. it uproots trees" (152). camagu also respects his people's customs when he prevents hotel workers from killing the snake that appears in his room because it is his totem. in contrast, xoliswa, who adopts western knowledge as universal, dismisses indigenous knowledge as nonsense: "what can we say about a man who believes in a snake?" (161). earlier her father bhonco and others too dismiss the believer's respect for indigenous trees and animals as "foolish" and "madness," and takes a homogenous view of nature in suggesting that native trees could easily be replaced with "civilized trees" (146-7) . the heart of redness's indigenous cosmopolitics positions indigenous knowledge as frustrating bhonco's attempt to deploy as a universal a western definition of politics as reserved exclusively for humans and his attempts to uphold a human/ nature binary. the "animist materialism," harry garuba's phrase, expressed in characters' spiritual views of these flora and fauna suggests a mode of resisting their instrumentalization. where bhonco reads them as lacking in use value-"these plants are of no use at all to the people. they are good neither as wood nor as food" (93)-qukezwa and other characters' animism values the animals and plants on their own accord. as garuba argues of animism, "objects thus acquire a social and spiritual meaning within the culture far in excess of their natural properties and their use value" (267). the reading of desire in the novel offered here aligns with cosmopolitan bioregionalism, animism, and indigenous cosmopolitics. where cosmopolitan bioregionalism offers a notion of place as process rather than defined space, this project focuses on challenging the defining or limiting views of subjectivity, desire, and other concepts that are also more processual. indigenous cosmopolitics emphasizes "non-representational affect" as key to its expanded notion of politics; theorizing desire, as one mode of affect, as a political potential to resist such exploitation coincides with these other concepts' emphasis on place and indigenous knowledge as modes of resistance. the ethics of sustainability that informs camagu's development of a cooperative calls into question the capitalist notions of western development. he discusses his cooperative with dalton, the trade store owner: i am talking of self-reliance where people do things for themselves. you are thinking like the businessman you are … you want a piece of the action. i do not want a piece of any action. this project will be fully owned by the villagers themselves and will be run by a committee elected by them in the true manner of cooperative societies. (248) his description confirms that his motive is "not for profit" but for creating more positive passions, more joyful lives for the villagers than the current work some of the villagers perform as workers in the mines, service workers at hotels, and the potential jobs that would come from the casino. the narrator describes these workers as receiving racist treatment at the hands of white tourists and also receiving poor wages. camagu makes his opinion of the casino proposal as an unsustainable option clear at one of the meetings the villagers have with the developers. "it is of national importance only to your company and shareholders, not to these people!" he yells. "jobs? bah! they will lose more than they will gain from jobs. i tell you, people of qolorha, these visitors are interested only in profits for their company. this sea will no longer belong to you. you will have to pay to use it" (200). part of the loss from these new jobs will include the devaluing of local customs, knowledge, and labor, and the inclusion of the work done by villagers into the economy of exchange in capitalism that translates into profit for the western developers. camagu's desire is clearly for the people, and this desire for the community stems from his initial desire for qukezwa and his knowledge of its importance to her. his anti-oedipal desire therefore counters the capitalist desire of the developers. as mentioned earlier, camagu arrives at his position on the proposal for the casino resort after his discussions with qukezwa. indeed, the arguments he voices at the village meeting with the developers are those she expressed to him earlier. having a ph.d. in "communication and economic development" (29) from the us, camagu at first finds the casino proposal unproblematic. in fact, early in the novel he adopts more of a capitalist logic of desire as lack and it is qukezwa's teachings that change his views about desire and his relation to others. at the novel's outset, camagu is about to leave south africa to return to the us for a job in economic development, and yet it is his desire that derails his trip, it is desire that brings him to qolorha. as in the whale caller, mda here distinguishes the protagonist's desire from narcissistic desire. after hearing the song of a funeral singer, a "makoti" (28), he cannot get her out of his mind: he becomes breathless when he thinks of her. he is ashamed that the pangs of his famous lust are attacking him on such a solemn occasion. but he quickly decides it is not lust. otherwise parts of his body would be running amok. no, he does not think of her in those terms. she is more like a spirit that can comfort him and heal his pain. a mothering spirit. and this alarms him, for he has never thought of any woman like that before. (28) while all of his relations to women previously are of a selfish nature and about accumulating sexual pleasure for himself, and he is ethically deficient in this regard as he pays his servant to have sex with him in a way that the narrator compares to the rape of a slave by her master (28), his desire for this woman is not of a self-serving kind; it is this desire for her that motivates him to seek her out again in qolorha. thus, while he is self-interested and narcissistic in his use of others for sexual pleasure at the novel's beginning, he comes to approach desire differently after this experience with the makoti and after learning from qukezwa. in contrast to the earlier one-sided affairs of camagu's lust and use of women, both he and qukezwa have sexual dreams about each other: "mutual dreams. messy dreams" (171). this transformation of his relation with women from a position of dominance to a mutual relationship brought about by qukezwa suggests that she is a feminist character. indeed, harry sewlall dubs her "the quintessential ecofeminist" (113), for her thorough knowledge of the plants and animals of her habitat, her challenges to the patriarchal traditions of the villagers, her dressing in traditional garb, and her educating others in the village about the environment and living in a sustainable way. yet, as caminero-santangelo convincingly argues, the novel's characterization of qukezwa is not an idealization of the indigenous as some critics hold, since she is more complex, transformed by history and cultural contact: "such characterizations [of qukezwa as the idealized ecofeminist] suggest that mda reinforces the notion of an unchanged indigenous ecosystem that existed before the impact of colonialism and advocates for a return to an indigenous, properly ecological relationship between human and nonhuman nature." in other words, qukezwa sees the similar logics of oppression at work that seek to disenfranchise animals, women, and others from a position of full standing and as deserving of the protections of the community. her ecofeminism becomes clear, especially in the scene where she seeks to defend her environmentalist practices of killing some foreign water-depleting trees before the council of elders, challenging the lower legal status afforded to women in traditional xhosa laws by gesturing to the laws of the "new" south africa that prevent gender discrimination. qukezwa's role as a mother to heitsi and her teaching him to swim in the sea at the novel's end demonstrate a particularly south african feminism that embraces motherhood as a political act, a mode of feminism in the country that as zoë wicomb explains differs greatly from the largely negative view of family roles in western feminisms. her teaching her child to swim in the sea, in relation to which she has played perhaps the most significant role in protecting it from being stolen from the community by the developers, confirms her feminism as a robust ecofeminism. qukezwa also plays a role in deterritorializing camagu's once capitalist desire as he no longer narcissistically spends his time seeking his own pleasures and profits at the expense of others. animals seem to play a role in this transformation of sexual desire as he, rather like the whale caller, achieves orgasm seemingly incidentally in the presence of an animal and in response to song, in this case while he and qukezwa both ride on the horse gxagxa: "[h]is pants are wet … . it is not from sweat" (152). at this point in the novel, camagu becomes enthralled with qukezwa, especially her singing rather than with her looks. in fact, the more "civilized" and western potential love interest xoliswa is known for her beauty which rivals that of models. after their ride on gxagxa, "[h]e remembers … when she sang him to an orgasm" (174). like nick morris in the reluctant passenger, at first he fears this different kind of non-human desire and seeks to maintain control over this zoë: "he must get away from these surroundings that are haunted by qukezwa's aura. he must fight the demons … he must try to be in control" (149). as he is "spellbound" and not in a dominant position of control as in his previous sexual experiences where he used women, the scene indicates a more positive experience of desire. this horseback ride, apparently, results in qukezwa's pregnancy-a strange, non-normative chance pregnancy that occurs incidentally during a fully clothed ride. conceived at this moment of non-human desire and intensity, without sexual intercourse, while atop a horse, their child heitsi figures as a future for the community where desire will continue to offer new ways of thought and creativity to resist neocolonial threats. while dominant culture might view such an act as dirty, weird, or something to be prevented, or even as a sort of violence to the horse, mda's novel indicates that the relationship between qukezwa and gxagxa is positive and ethical: "they love each other, gxagxa and qukezwa … . her father lives in this horse. she wouldn't dare do anything shameful in its presence … . she gives it the same kind of respect" (275). her sensual encounter with camagu while riding gxagxa in this regard is not "shameful" or pejorative but perhaps a moment of shared intensity and love between humans and animals. earlier, qukezwa draws attention to the colonization of camagu's thought that results from his american phd in economic development and highlights how this colonization informs his initial reaction to the proposal for the casino resort: vathiswa says they made you a doctor in the land of the white man after you finished all the knowledge in the world. but you are so dumb. white man's education has made you stupid. this whole sea will belong to tourists and their boats and their water sports. those women will no longer harvest the sea for their own food and to sell at the blue flamingo. water sports will take over our sea! (103) like nongqawuse, qukezwa desires to protect her community, a community which includes animals, plants, and the people of qolorha. after camagu argues that the village will be paid for this, and that the development will create jobs, she further challenges his thinking: what do villagers know about working in casinos? … . i heard one foolish unbeliever say men will get jobs working in the garden. how many men? and what do they know about keeping those kinds of gardens? what do women know about using machines that clean? well, maybe three or four women from the village will be taught to use them. three or four women will get jobs. as for the rest of the workers, the owners of the gambling city will come with their own people who are experienced in that kind of work. (103) thus it is qukezwa who is responsible for protecting the community, alongside the changed camagu, who decides to stay in qolorha instead of leaving for the us for his own financial gains, a decision to stay in south africa that nick morris makes as well in the reluctant passenger. therefore anthony vital's claim that "the united states is represented also as providing the central character with the economic understanding that protects the local from outside exploitation" (306) seems to fail to recognize qukezwa's knowledge and influence on camagu's thought and desire. qukezwa's assessment of the proposal is accurate, and the way in which the proposal is framed to benefit the community works just like traditional colonial logic of the civilizing mission, where the colonizer's behavior is presented as a benefit for the people, when really its goal is to further disenfranchise them so that the politicians and developers can "eat." mda points to this colonial history as well in portraying george gray's taking of the xhosa's land in return for "civilizing" them. this ethics of sustainability in the heart of redness is not one of moral universalism but instead one that acknowledges the importance of local or indigenous knowledge. harry sewlall describes the novel's representation of this knowledge by pointing to the importance of the local court's treatment of qukezwa for cutting down foreign trees: what emerges at the village trial of qukezwa is that the indigenous people of this land have always had their own laws to protect the environment. while qukezwa's actions are considered criminal because there are no laws proscribing wattle trees, there are traditional laws in place which allow the destruction of noxious weeds and plants, such as the mimosa. (114) the novel highlights multiplicities of perspectives, times, and values concurrently, as mentioned in the contrasting positions of the believers and unbelievers, but also in dalton and camagu's different plans for the village as either a cultural tourism site or a nature tourist site. the administration of the local laws of the amaxhosa reveals that the elders of the village who make rulings do not view the law as static or transcendental. for example, although the "old law" (213) regards any woman not married as a minor, they listen to the unwed twenty-year-old qukezwa's arguments against this law: "[i]n the new south africa where there is no discrimination, it does not work" (213). at this, the chief replies: "now she wants to teach us about the law" (213). while bhonco's daughter xoliswa ximiya is officially a teacher, it is qukezwa who becomes a more active teacher in the community. as mentioned earlier, bhonco and his daughter xoliswa eurocentrically denigrate most traditional customs and practices as "backward" and "uncivilized," embracing instead many western and american ideas about lifestyle, the natural world, and development. this extends to local flora and fauna, as bhonco asserts: "we want to get rid of this bush which is a sign of our uncivilized state" (92). zim and his daughter qukezwa, by contrast, follow traditional xhosa customs, practice indigenous environmental knowledge, and greatly value local biota, rejecting many of the western ideas introduced into their community. qukezwa and zim's embracing of tradition challenges bhonco and xoliswa's eurocentricism, yet it too is not without problems. in her chapter that focuses in part on heart of redness from her "wilderness into civilized shapes:" reading the postcolonial environment, laura wright reads some characters' engagement with traditions in mda's novel in terms of bhabha's notion of "colonial mimicry," arguing that they "rely on imagined identification with a now inaccessible and uninhabitable past, while simultaneously subverting and parodying that past in an attempt to monetarily benefit from its value as a marketable commodity" (21-2). she explains the problems of this exploitation of tradition in john dalton's obviously business-oriented and self-interested plans for a cultural village as she notes camagu's view of such a packaging of tradition as "inauthentic" and as "deny[ing] the value of contemporary xhosa culture" (50). wright also astutely observes how dalton's planned last-minute heroics by withholding the letter he secured declaring the village a protected heritage site is an example of a "colonial mentality that indigenous peoples were not capable of caring of themselves" (53). however, she also has problems with qukezwa's drawing from xhosa traditions. wright views qukezwa's focus on tradition and removal of invasive plants as taking part in a postcolonial tendency of "ineffective … attempts at establishing various prelapsarian-and imaginary-african edens, impossible landscapes that are somehow uncompromised by their postcolonial status" (23). while she argues that both the believers and unbelievers attempt to borrow and invent traditions in ways that are appropriative, qukezwa's attempts to "recreate" (51) tradition seem to occur without such appropriation. like bhonco, zim seems somewhat extreme, but in the other direction, in his embracing of past traditions, selectively deploying them at times in the imaginary fashion that wright identifies in order to emphasize his difference and purity from bhonco as when, for example, he shaves off his eyebrows. however, qukeswa's drawing from tradition and indigenous knowledge, and perhaps from nongqawuse's future-oriented biopolitics, is free from this edenic imaginary and approaches instead an attempt to serve the best interests of the community by exercising an ethics of sustainability. in this sense, qukezwa's breaking the traditional laws to cut down certain invasive and water-extracting trees might be seen as more in line with the extralegal efforts of the characters in heyns' reluctant passenger to protect their community and the baboons. perhaps the difference in readings comes here from wright's attempts to read the plants in mda's novel as metaphor: "plants function as metaphors for colonizers and colonized peoples, and the invasive species that characters seek to eradicate generate no hybrid entities" (14). the fact that there are no hybrid plants is surprising and supports wright's view nicely. however, there are issues with such a metaphorical reading. after acknowledging that the killing of invasive plants can be read in a literal sense as well, wright goes on to emphasize the plants as metaphor as she attempts to read qukezwa's killing of plants as a "shortsighted solution to white intrusion": "removing all invasive plant species not only would be impossible, but also such an action can only operate on a metaphoric level" (51). reading the invasive plants in a literal sense instead of as a metaphor for colonizers, we might appreciate qukezwa's environmental conservation efforts to preserve her community's water further. reading these scenes of the killing of flora and of community exclusions in terms of biopolitics enables more careful attention to the different kinds of life under consideration and the ethics of hospitality that pertain to them. wright's reading of qukezwa's biopolitical management of flora as metaphor also seems to ignore differences between kinds of life and the idea that qukezwa does not seek to remove all whites from the community in a xenophobic fashion. in fact, it is bhonco who seeks to remove dalton and other non-xhosa people by deploying a purist and prelapsarian rhetoric, as i discuss below, when he attempts to expel those from the community who disagree with his position on the casino development or who otherwise frustrate his ambitions. if bhonco is extreme in his disdain for local flora and fauna, and in his willingness to sacrifice indigenous plants, animals, and knowledges for english ones, zim is somewhat extreme in his love of all that is traditional and disdain for the foreign. yet quekezwa does not kill some of the foreign trees to restore an eden or out of a xenophobic impulse but out of concern for the community's water supply. bhonco's concerns seem more self-centered and short sighted. he becomes a kind of nationalist manager when he threatens camagu's membership of the community in response to camagu's anti-development arguments: "who are you to talk for the people of qolorha? … you talk of our rivers and our ocean. since when do you belong here? or do you think that just because you run after daughters of believers, that gives you the right to think you belong here?" while seeking to win the argument for the development, bhonco attempts to do so by excluding camagu from the community and from being a subject of rights in the community, enacting a biopolitics that threatens to remove those who are not pure enough, not xhosa enough. qukezwa doesn't seek to banish all the plants from the region, just those that greatly diminish the water supply and threaten the ability of other plants to survive. while she initially emphasizes that the trees she cut down are "foreign trees!" she explains that she did so because they are like the inkberry, which "destroys everything before it!" (215). bhonco attempts to discern and charge qukezwa with xenophobia by picking up on the "foreign" in her explanation: "are you going to cut down trees just because they are foreign trees?" asks bhonco indignantly (216). in her reply, qukezwa explains that she is not against trees just because they are foreign; instead, she kills the trees that harm the community. making biopolitical decisions about what must be sacrificed for the future of the community, qukezwa explains to the elders why she cuts certain trees and doesn't cut others: the [foreign] trees in nogqoloza don't harm anybody, as long as they stay there … . they are bluegum trees. the trees that i destroyed are harmful as the inkberry. they are the lantana and wattle trees. they come from other countries … from central america, from australia … to suffocate our trees. they are dangerous trees that need to be destroyed. (216) in reply, bhonco asserts that the traditional law doesn't allow for the killing of these foreign trees without permission, and qukezwa argues for the law to be changed because the wattle tree "uses all the water" (216). the law doesn't allow for the killing of the inkberry without permission either, yet everyone knows its harmful qualities and allows its cutting anyway, without the law's approval. qukezwa argues that this is the extralegal precedent for her actions, explaining: "[the wattle] is an enemy since we do not have enough water in this country" (216). in this scene, qukezwa decides to remove those plants that threaten the community's future, just as the earlier believers killed the cattle, effectively stopping the viral spread of the european lung sickness that was decimating their cattle and horses. the opening of the novel also confirms that the environmentalist efforts of the xhosa have been successful in securing a sustainable present: "indeed, qolorha-by-sea is a place rich in wonders. the rivers do not cease flowing, even when the rest of the country knells a drought. the cattle are round and fat" (7). described here as wonders, perhaps alluding to the magical realism of the novel and its prophets, the report on the state of the animals and environment suggests that environmentalist practices have created a sustainable relationship with the land where other parts of the country suffer water shortages. the comment about the healthy cattle follows the positive assessment of waters in qolorha, suggesting that the cattle-killing movement and the sustained interest in conserving water has in some measure helped to sustain the environment and the future of the community. bhonco, conversely, upholds the law at all costs in this case, further proving that it is desire which is actually in the place of law. although the ruling of the elders is interrupted by a fire that burns a few of the villagers' homes, the elders mostly disagree with bhonco as it's clear that he is just interested in punishing qukezwa because she is a believer, and zim's daughter at that. rather like judge conroy in the reluctant passenger, who seeks to use the law to abuse his rival brick tomlinson, bhonco appeals to the law in hopes of seeing zim punished for his daughter's crimes: "why doesn't he stand up like a man and take the rap?" (214). bhonco's desire is reterritorialized, seeing as he has no problem with the development of the casino city, which would break these laws, a project which the developers reveal involves the killing of many of the village's trees: "how can we call it a grove when we're going to cut down all these trees to make way for the rides?" in response, the other developer remarks: "[w]e'll plant other trees imported from england. we'll uproot a lot of these native shrubs and wild bushes and plant a beautiful english garden" . in contrast to the developers and bhonco, whose desire is self-interested, and who arbitrarily upholds the law when it suits him (and it is perhaps significant in this regard that bhonco's frustrations with his inability to secure his old-age pension from the government is a frequent sore spot for him throughout the novel), qukezwa's actions are motivated by a desire to protect her community; in this instance, specifically the local plants and water supply of qolorha. as the history of the amaxhosa wars with the british colonists and qukezwa's killing of colonizing plants make clear, the response to new things and deciding on their belonging to the community or not often involves a consideration of how these new people and things harm or "eat" the community, or if they further protect it. bhonco at times wants to expel dalton, descendent of a british colonial officer, and camagu, who at times he calls a foreigner. he decides that these "outsiders" do not belong to the village community in relation to how their presence or absence would personally benefit him, not the larger community. he has repeated arguments and later a violent encounter with dalton, for example. the racial inflections of dalton's status in the community highlight the various modes of biopolitical management at work in qolorha and demonstrate characters' anxieties about belonging and their relationship to the land as "home." these concerns about who belongs and who doesn't, how many, who belongs most, and the desire for a space that makes it feel homely according to a particular imaginary or fantasy recall the discussion of "nationalist managers" and homely space in disgrace in chap. 2. camagu has the most obviously ambiguous relationship with the community of qolorah as home and, indeed, with south africa. he doesn't feel at home in johannesburg, in part because he can't dance the toyi-toyi (the freedom dance of the struggle) because he was exiled for 30 years and never learned it (28), which results in his being excluded from a number of employment opportunities. in qolorha, he embraces his totem animal, a snake, in a way that impresses the villagers by showing them that he is like them and belongs. roman bartosch, through a citation of harry garuba's definition of "animist materialism," argues that camagu's respecting his totem animal is a "deliberate re-traditionalisation as described by garuba" and suggests that "he is calculating ('i have gained more respect […] since they saw i respect my customs')" (bartosch 170) . while this is an interesting reading, it neglects to consider that camagu respects the snake first, and only later understands the influence it has on others' perceptions of him. a calculating gesture would suggest more deliberate and perhaps insincere performing of respect. camagu, by contrast, seems genuinely joyful to have encountered his totem animal: "camagu is beside himself with excitement. he had never been visited by majola, the brown mole snake that is the totem of his clan … . he is the chosen one today" (98). where not knowing how to dance the toyi-toyi prevents camagu from belonging and imagining himself at home in the city, his ability to respect the customs of his people and his affective response enables a kind of assertion of belonging and imagining of a homeland in qolorha. the descendent of a colonial official, dalton too attempts a certain imagined relation to the community in denying this legacy. he replies "'it is not true! it is not true!' " to bhonco's point that "he is a descendant of headhunters" (168). while he is a "white man of english stock," he has an "umxhosa heart" (8), and zim argues that "dalton is not really white … it is just an aberration of his skin. he is more of an umxhosa than most of us" (147). dalton's particular imagined relationship and belonging to the community, through knowledge of the language and participation in its rituals such as circumcision, performs a rhetoric of belonging that attempts to ignore or elide the colonial past. yet he still benefits from his position of white privilege in south africa in belonging to the "white" community, and even continues some racist practices against the villagers, as when he makes bhonco ride in the back of his truck, a common mode of segregated, racist travel practiced by white men during apartheid: "the old man [bhonco] struggles to climb into the back of the bakkie. even though dalton is alone in the front seat, customs do not die easily. dalton can see a hint of anger on the elder's face" (141). in this sense, dalton imagines a relationship to both communities: the white nationalist community and the xhosa village. he also seeks to establish a connection to the land through his marriage to an afrikaner-the afrikaner "belongs to the soil. he is of africa"-and asserts to his friends who are leaving south africa: "this is my land. i belong here" (139). these imagined relationships to land and community through certain kinds of belonging and nationalism often demonstrate the kind of willful cognitive dissonance that characters take on in order to feel at "home" as they navigate their relationships to the past, to the land, and to the community. the imagined relationships also reveal the violence that results from certain rhetorics of "home" as characters often seek to exclude or treat poorly those they deem not "pure enough" or foreign. foucault observes this violence in the racism of biopolitics: [r]acism makes it possible to establish a relationship between my life and the death of the other that is … a biological-type relationship: 'the more inferior species die out, the more abnormal individuals are eliminated, … the more ias species rather than individual-can live, the stronger i will be, the more vigorous i will be. i will be able to proliferate. the fact that the other dies does not mean simply that i live in the sense that his death guarantees my safety; the death of the other, the death of the bad race, of the inferior race (or the degenerate, or the abnormal) is something that will make life in general healthier: healthier and purer. (255) foucault explains in this discussion that the death he's discussing is not just literal but also "indirect murder: the fact of exposing someone to death, increasing the risk of death for some people, or, quite simply, political death, expulsion, rejection, and so on" (256). bhonco's seeking to expel certain "impure" characters from the community that thwart his ambitions of wealth and social climbing to an elite status through westernizing himself, the environment, and the community exhibit this kind of racist bipolitics. his attempt to get zim and qukezwa punished legally, weakening their political standing, and indeed his risking of the community's water and the lives of the animals through attempting to stop the environmentalists, evidences a violent biopolitics that continues in a racist, colonial legacy. camagu's presence in the village is obviously not a problem initially when bhonco welcomes him energetically as a westernized south african and because he thinks camagu might marry his daughter. as it becomes clear that camagu's desire is for qukezwa instead, bhonco argues that he and dalton should be expelled from the community for their not being "pure" amaxhosa or their not being born in qolorha. however, this logic of exclusion based on categories only suits his desire for "development" and what he thinks will be his personal benefit and profit. indeed, he often disavows the importance of local knowledge, allowing western notions of "development" and civilization to inform his thinking about biopolitical decisions. in building his case against qukezwa for destroying the water-depleting trees, he argues that it is unjust to absolve her when "white tourists" were recently arrested for "smuggling cycads" and boys were also punished "for killing the redwinged starling, the isomi bird" (216). the elders reply to bhonco's argument by noting the difference of life under consideration here: "shall we now be required to teach revered elders like bhonco about our taboos? it is a sin to kill isomi. yes, boys love its delicious meat that tastes like chicken. but from the time we were young we were taught never to kill isomi … . we only desired them from a distance" (217, emphasis added). the traditional laws and words of the elders here express a desire for animals that respects their lives and membership in the community and results in the community protecting them from being eaten. the passage highlights the differing models of desire at work in qolorha as the indigenous notion of desire frustrates the view that capitalist desire is a universal or the only way to desire animals. this other way of desiring challenges the tourists and those who seek only a relation to the animals of eating, thereby showing capitalist desire to be but one way among other, different possibilities. the passage reveals that not only have the xhosa in the heart of redness long had their own environmental laws, as sewlall suggests, but also they've long had their own ways of desiring animals. in contrast to bhonco, qukezwa, evaluates newcomers to the community in relation to the harm they may cause or, alternatively, their ability to further protect and sustain the community. indeed, qukezwa works for the white dalton and begins a romantic relationship with the non-xhosa, camagu, that results in a hybrid child and future. bhonco's attempts to expel camagu and dalton from the community, as well as his approval of the sacrifice of the non-human life of qolorha for the casino city, suggests that his approach to the law relates to what derrida calls an autoimmunitary problem. wolfe writes about the need to deconstruct species and race as a way to prevent this problem: "[r]ace and species must, in turn, give way to their own deconstruction in favor of a more highly differentiated thinking of life in relation to biopower, if the immunitary is not to turn more or less automatically into the autoimmunitary" (56). in other words, bhonco's use of these categories at times as a way to challenge the membership of these others in the community risks the sustainability of the community in the expelling of its diversity, especially considering that it is dalton and camagu who, with the assemblage of other community members, ultimately successfully resist and prevent the development of the casino city. wolfe discusses the desire for sameness that pertains to the law, and how derrida's notion of "hospitality" can challenge this problem in its ethical response to the other: [t] he reason that this [the ideal of unconditional hospitality] is crucial to biopolitical thought is that it keeps that zone of immunological protection from automatically turning to, as derrida puts it, an autoimmune disorder. the idea is that once you start drawing lines between humans and animals, aryans and jews, muslims and christians, that is always going to lead to the runaway train process of an autoimmune disorder. so eventually, you know, how aryan is aryan enough? how christian is christian enough? how human is human enough? how "proper," to go back to heidegger, is proper enough? the horizon of unconditional hospitality as something to strive for is precisely calculated to remind you that whatever those lines are that you are drawing have to be always taken under erasure, even as, pragmatically those lines have to be drawn and are drawn all the time. ("after animality" 184) bhonco's desire to expel particular members out of the community then evidences this kind of autoimmune disorder as he accuses people of not being xhosa enough at times when it suits him and, at others, of not being civilized enough. in essence, bhonco seeks to improve himself, and to that end approves of the casino city, not recognizing its neocolonial nature, and thus advocating the sacrifice of the local land, animals, and other members of his community for the building of the casino. in contrast, the other characters consider sacrifice in terms of the protection of their community, including its human and non-human members. qukezwa responds differently to the biopolitical problems of protecting her community-with hospitality. wolfe quotes derrida's description of hospitality: "'pure and unconditional hospitality, hospitality itself, opens or is in advance open to someone who is neither expected nor invited, to whomever arrives as an absolutely foreign visitor, as a new arrival, nonidentifiable and unforeseeable, in short, wholly other'" (before the law 92). rather than write off or automatically exclude foreigners from the community, qukezwa responds ethically to camagu and the other new arrivals to qolorha, including flora and fauna. to be sure, she does not welcome everything in an unconditional hospitality because to do so, as wolfe observes, would be to become apolitical and unethical: "[d]iscrimination, selection, self-reference, and exclusion cannot be avoided, and it is also why the refusal to take seriously the differences between different forms of life-bonobos versus sunflowers, let's say-as subjects of immunitary protection is, as they used to say in the 1970s, a 'cop out'" (103-4). qukezwa clearly exercises discrimination in deciding which plants, animals, and people are welcome to be part of her community and which aren't, often on the basis of their colonizing or harming the life and futures of the other members of the community. toward the novel's end, the community stops the casino development when dalton gets a court order declaring qolorha a "national heritage site" (269), something camagu had suggested earlier in response to the developers' "how will you stop us?" the location's history of nongqawuse's prophecies that led to the cattle-killing movement renders it worthy as a potential site deserving protection. as dalton protects the community in a roundabout legal way, mda's novel provides another example of how desire exists where we think there is law to protect communities. camagu and dalton, in their desire to protect the community, think that this alternative way to ensure the casino development will not go through. thus, in addition to qukezwa's ethical response to protecting her community, nongqawuse's prophecies, her desire to protect the community in thinking toward the future that led to the cattle-killing movement in the 1850s in response to colonization that brought with it lung disease for the cattle, disease for the amaxhosa's crops, and the starvation of many of the amaxhosa, while tragic, continues to protect her people via the national heritage site enabling further sustainable futures. laura wright observes this as well: if there is any hope to be had, the polyphonic and temporally simultaneous structure of the text seems to suggest, it is in the cyclical and nonlinear nature of history wherein nongqawuse can be read at once as the cause of a people's destruction in the past and, through her cultural cachet as such a figure, their salvation in the present and as the girl whose failed prophecy in 1856 is fulfilled late in the twentieth century. (54) 3 although following the prophecy of nongqawuse was devastating for the amaxhosa, mda offers it as an ethical attempt to bolster the immunity of the community. j.b. peires explains the biological conditions that resulted from the colonial contact and led to the cattle killing: an important cause of the cattle-killing was the lungsickness epidemic which reached xhosaland in 1855. cattle mortality was as high as one half to two thirds in some places, and many xhosa lost all their cattle. the great believer chief phatho, for example, lost 96 percent of his 2500 cattle … the xhosa began to believe that their cattle were rotten and impure, and that they might as well kill them since they were probably going to die anyway. (312) in this light, part of the logic that informs the movement is the attempt to limit the spread of the disease, to prevent it from attacking all the cattle. another aspect of the logic of sacrificing the cattle involved the hope that it would remove the british colonists: cattle-killing was born partly out of xhosa frustration at colonial domination and partly out of the hope awakened by the news that the russians had beaten the english … . among the many predictions that circulated at the time was one to the effect that the english, like all other evil things, would be swept away in the great storm which would precede the resurrection of the dead. (peires 316) peires also explains that, alternatively, many also believed the sacrifice would amend the conflicts and bring peace between the british and the amaxhosa nation. perhaps the greatest reason for the british "success" in colonizing the amaxhosa, then, is this cattle disease that "was brought to south africa in september 1853 by a dutch ship carrying friesland bulls" (peires 70) as it functioned essentially as a kind of biological weapon in the war between the british and the amaxhosa. the slaughtering of the cattle in an attempt to prevent the spread of this disease is an exercise in biopolitics. as wolfe notes in critiquing affirmative biopolitics that fail to consider the difference of life-those approaches that view all life as equal-such an approach isn't practical (or perhaps desirable) given the destructive nature of some life forms: "[d]o we extend 'unconditional hospitality' to anthrax and ebola virus, to sars?" (before the law 93). in the heart of redness, environmentalist characters often perform a biopolitics and hospitality that is not always affirmative but discriminates and seeks to eliminate the lung sickness, water-depleting plants, and neocolonial developments that would decimate the community. in the face of such an attack on the immune system of the community, king sarhili's decision to follow the words of the prophetess exercises an ethical attempt to protect and sustain the community. of course, as history bears out, the situation and decision were devastating: one of the figures offered for the drop in the human population of the xhosa people from the cattle killing is an estimated loss of 40,000 over a twoyear period. also, 400,000 cattle were slaughtered and the xhosa lost 600,000 acres of land to the british (peires 319). these tragic figures highlight the vulnerability of bodies that humans and animals share. they also point to the great dependence of the community on these non-human others for survival. emphasizing our limited knowledge, and that to act at all we can only respond with a conditional hospitality, wolfe writes of biopolitics: we must choose, and by definition we cannot choose everyone and everything at once. but this is precisely what ensures that, in the future, we will have been wrong. our 'determinate' act of justice now will have been shown to be too determinate, revealed to have left someone or something out. (104) while the cattle killing may appear to have been "wrong" from the perspective of today as it can be seen as being responsible in part for the devastation of the amaxhosa community-peires notes that some view it as a mass suicide, although he clearly disagrees with this view-in light of the biopolitical decisions exercised by qukezwa in the present of the heart of redness, mda situates the movement as an attempt to act politically and ethically to protect the community. mda's novel emphasizes, as peires also argues, that the tragic deaths of the amaxhosa community were caused by the colonizing disease of lung sickness as well as the colonizing british, both of which established a relationship of "eating" these communities. just like the development project of the casino city, which attempts to colonize and devastate the community, the british colonization during the cattle-killing movement was geared towards ruining the amaxhosa nation: the cattle-killing cannot be divorced from the colonial situation which was imposed on the xhosa in 1847 by sir harry smith … it should be remembered that the essential objectives of grey [sir george grey] were identical to those of smith and of colonial rule generally: to destroy the political and economic independence of the xhosa, to bring them under british law and administration, to make their land and their labor available to white settlers, and to reshape their religious and cultural institutions on european and christian models. (peires 313) peires' passage describes an organization of labor and the community that would be replicated in a slightly new form by the international development company's proposal. yet by deterritorializing desire away from the narcissism of colonization and global capitalism toward a postcolonial desire, one for the benefit of the members of the community, qukezwa and the others of the assemblage, including camagu and dalton, work to fend off the disposal of the community by an international development corporation, exercising an ethical biopolitics that continues in the tradition of the prophetess, and, for the time being, she temporarily secures her community's protection and its potential for a future. in addition to the government officials who support the casino in the heart of redness, chief xikixa, who is charged with protecting the land where it "is illegal to build within a kilometer of the coast," also puts his own profits and pleasure ahead of the community. he gives the land away to wealthy white people and "some well-to-do blacks," some of whom build "right on the seashore," for bribes such as a "bottle of brandy" and later on "cellphones and satellite dishes" (68). these products of globalized capitalism bring the village of qolorha into the global economy, threatening the life and future of the community as it is rendered exchangeable for a cheap price, and for the pleasure and profit of a few. in both heyns and mda's novels, the commodification of the lands of local communities and the disposing or harming of the interests of their residents, human and non-human, are thwarted through what i'm describing as the postcolonial desire of an assemblage of characters, a desire for the community in a broad sense that disrupts and resists the colonizing ambitions of capitalism and its adherents. as braidotti argues, in the context of biotechnology, zoe exceeds capitalist control: "nature is more than the sum of its marketable appropriations: it is also an agent that remains beyond the reach of domestication and commodification" (transpositions 47). if capitalism seeks to commodify all of life and proliferate its logic of desire of lack through colonizing the unconscious, postcolonial desire describes a potential of desiring machines that escapes, resists, or undoes this colonization in a line of flight away from capitalism's reterritorialization of desire, reassembling communities around an ethics of sustainability instead of an accumulation of personal profit. where some global capitalists see an opportunity in the "under-developed" lands or villages to secure a profit at the expense of destroying and devastating its inhabitants, the resistances offered by these human and non-human assemblages disrupt the capitalist machine and, for the time being, protect the futures of their homes. in both the reluctant passenger and the heart of redness, the laws passed to protect these communities repeatedly fail to do so, often as a result of the compromised position of those tasked with upholding the law. while these authorities, judges, and politicians seek their own profit at the expense of the community, they reveal their colonization by capitalist logic. through weaving the history of the cattle-killing movement into the narrative about the present-day proposed casino city, zakes mda emphasizes the colonial legacy in which global capitalism operates and continues in the practices of capitalists and government officials from developed countries and their counterparts in "developing nations." heyns' novel focuses more specifically on protecting a troop of baboons instead of protecting a larger community of human and non-humans, as in mda's novel. nonetheless, the critique of the capitalist development of the baboon's home in the nature preserve also undermines the workings of the apartheid regime more broadly, in this case the animal testing and other exercises in biopower of the apartheid state on south african bodies. for both novelists, then, the explicit violence exerted on communities, on bodies, and on the land in the pasts of colonialism and apartheid reappears in a subtler and more nuanced fashion in the present of late capitalism through the weakened and compromised administration of the law which fails to fully protect communities from the threats of disposal and violence. mda and heyns represent desire as a resistance to this neocolonial threat that might better protect these communities and their futures from being consumed by the capitalist machine. notes 1. see jacques derrida, "before the law," in acts of literature, ed. derek attridge (new york, ny: routledge, 1992), 181-220. derrida also emphasizes this emptiness in noting the lack of an origin for the law in "before the law:" "what is deferred forever till death is entry into the law itself, which is nothing other than that which dictates the delay … what must not and cannot be approached is the origin of difference: it must not be presented or represented and above all not penetrated. that is the law of the law, the process of a law whose subject we can never say, 'there it is,' it is here or there" (205 peires. in the dead will arise, peires details how although extremely tragic for the amaxhosa, nongqawuse's prophecies and the decision to slaughter cattle resulted from extreme circumstances of british colonization and disease. the slaughter of most of the amaxhosa cattle, then, offers an example of a biopolitical issue. for example, peires writes "that the cattle-killing was a logical and rational response, perhaps even an inevitable response, by a nation driven to desperation by pressures that people today can barely imagine. i further believe, and i trust that the book will demonstrate this too, that the cattle-killing would not have been so fatal an error had it not been for the measures of governor grey, which first encouraged and then capitalized on the movement" (x). the unfortunate coincidence of increased pressure from british colonization and the lung the amaxhosa's decision to slaughter their cattle as a way to preserve their remaining community. as peires and mda's novel bears out, the decision to slaughter the cattle after the telling of nongqawuse's prophecies therefore figured as an attempt to secure the futurity of the amaxhosa people, even while it ultimately caused so many of them to die their alternative proposals prevent the immediate "development" of the casino, which would surely spell the ruin of the community, rendering it unsustainable. mda seems to acknowledge that this approach of ecotourism is not exactly the most radical approach either, as his later novel, the whale caller what do human rights do? an anthropological enquiry environmentality: ecocriticism and the event of postcolonial fiction what is sex? an introduction to the sexual philosophy of gilles deleuze nomadic subjects: embodiment and sexual difference in contemporary feminist theory after animality, before the law: interview with cary wolfe left legalism/left critique in place: tourism, cosmopolitan bioregionalism, and zakes mda's heart of redness indigenous cosmopolitics in the andes: conceptual reflections beyond 'politics kafka: toward a minor literature. translated by dana polan before the law without offending humans: a critique of animal rights 17 march 1976 lecture explorations in animist materialism: notes on reading/writing african literature, culture, and society the problem of ideology: marxism without guarantees the reluctant passenger. jeppestown: jonathan ball postcolonial ecocriticism: literature, animals, environment mda, zakes. fools, bells and the habit of eating: three satires mda, zakes. the whale caller in african literature: an anthology of criticism and theory the dead will arise: nongqawuse and the great xhosa cattle-killing movement of 1856-7 animal rights in south africa. cape town: double storey books ecofeminism in zakes mda's the heart of redness situating ecology in recent south african fiction: j.m. coetzee's 'the lives of animals' and zakes mda's 'the heart of redness to hear the variety of discourses before the law: humans and other animals in a biopolitical frame the animal gaze: animal subjectivities in southern african narratives wilderness into civilized shapes: reading the postcolonial environment the politics of necessity: community organizing and democracy in south africa key: cord-292094-vmsdhccp authors: mandell, lionel a.; wunderink, richard g.; anzueto, antonio; bartlett, john g.; campbell, g. douglas; dean, nathan c.; dowell, scott f.; file, thomas m.; musher, daniel m.; niederman, michael s.; torres, antonio; whitney, cynthia g. title: infectious diseases society of america/american thoracic society consensus guidelines on the management of community-acquired pneumonia in adults date: 2007-03-01 journal: clin infect dis doi: 10.1086/511159 sha: doc_id: 292094 cord_uid: vmsdhccp nan improving the care of adult patients with communityacquired pneumonia (cap) has been the focus of many different organizations, and several have developed guidelines for management of cap. two of the most widely referenced are those of the infectious diseases society of america (idsa) and the american thoracic society (ats). in response to confusion regarding differences between their respective guidelines, the idsa and the ats convened a joint committee to develop a unified cap guideline document. the guidelines are intended primarily for use by emergency medicine physicians, hospitalists, and primary care practitioners; however, the extensive literature evaluation suggests that they are also an appro-reprints or correspondence: dr. lionel a. mandell priate starting point for consultation by specialists. substantial overlap exists among the patients whom these guidelines address and those discussed in the recently published guidelines for health care-associated pneumonia (hcap). pneumonia in nonambulatory residents of nursing homes and other long-term care facilities epidemiologically mirrors hospital-acquired pneumonia and should be treated according to the hcap guidelines. however, certain other patients whose conditions are included in the designation of hcap are better served by management in accordance with cap guidelines with concern for specific pathogens. 1. locally adapted guidelines should be implemented to improve process of care variables and relevant clinical outcomes. (strong recommendation; level i evidence.) it is important to realize that guidelines cannot always account for individual variation among patients. they are not intended to supplant physician judgment with respect to particular patients or special clinical situations. the idsa considers adherence to these guidelines to be voluntary, with the ultimate determination regarding their application to be made by the physician in the light of each patient's individual circumstances. enthusiasm for developing these guidelines derives, in large part, from evidence that previous cap guidelines have led to improvement in clinically relevant outcomes. consistently beneficial effects in clinically relevant parameters (listed in table 3) followed the introduction of a comprehensive protocol (including a combination of components from table 2) that increased compliance with published guidelines. the first recommendation, therefore, is that cap management guidelines be locally adapted and implemented. documented benefits. 2 . cap guidelines should address a comprehensive set of elements in the process of care rather than a single element in isolation. (strong recommendation; level iii evidence.) 3. development of local cap guidelines should be directed toward improvement in specific and clinically relevant outcomes. (moderate recommendation; level iii evidence.) almost all of the major decisions regarding management of cap, including diagnostic and treatment issues, revolve around the initial assessment of severity. site-of-care decisions (e.g., hospital vs. outpatient, intensive care unit [icu] vs. general ward) are important areas for improvement in cap management. hospital admission decision. 4 . severity-of-illness scores, such as the curb-65 criteria (confusion, uremia, respiratory rate, low blood pressure, age 65 years or greater), or prognostic models, such as the pneumonia severity index (psi), can be used to identify patients with cap who may be candidates for outpatient treatment. (strong recommendation; level i evidence.) 5. objective criteria or scores should always be supplemented with physician determination of subjective factors, including the ability to safely and reliably take oral medication and the availability of outpatient support resources. (strong recommendation; level ii evidence.) 6. for patients with curb-65 scores у2, more-intensive treatment-that is, hospitalization or, where appropriate and available, intensive in-home health care services-is usually warranted. (moderate recommendation; level iii evidence.) physicians often admit patients to the hospital who could be well managed as outpatients and who would generally prefer to be treated as outpatients. objective scores, such as the curb-65 score or the psi, can assist in identifying patients who may be appropriate for outpatient care, but the use of such scores must be tempered by the physician's determination of additional critical factors, including the ability to safely and reliably take oral medication and the availability of outpatient support resources. icu admission decision. 7 . direct admission to an icu is required for patients with septic shock requiring vasopressors or with acute respiratory failure requiring intubation and mechanical ventilation. (strong recommendation; level ii evidence.) 8. direct admission to an icu or high-level monitoring unit is recommended for patients with 3 of the minor criteria for severe cap listed in table 4. (moderate recommendation; level ii evidence.) in some studies, a significant percentage of patients with cap are transferred to the icu in the first 24-48 h after hospitalization. mortality and morbidity among these patients appears to be greater than those among patients admitted directly to the icu. conversely, icu resources are often overstretched in many institutions, and the admission of patients with cap who would not directly benefit from icu care is also problematic. unfortunately, none of the published criteria for severe cap adequately distinguishes these patients from those for whom icu admission is necessary. in the present set of guidelines, a new set of criteria has been developed on the basis of data on individual risks, although the previous ats criteria format is retained. in addition to the 2 major criteria (need for mechanical ventilation and septic shock), an expanded set of minor criteria (respiratory rate, 130 breaths/min; arterial oxygen pressure/fraction of inspired oxygen (pao 2 /fio 2 ) ratio, !250; multilobar infiltrates; confusion; blood urea nitrogen level, 120 mg/dl; leukopenia resulting from infection; thrombocytopenia; hypothermia; or hypotension requiring aggressive fluid resuscitation) is proposed (table 4). the presence of at least 3 of these criteria suggests the need for icu care but will require prospective validation. 9. in addition to a constellation of suggestive clinical features, a demonstrable infiltrate by chest radiograph or other imaging technique, with or without supporting microbiological data, is required for the diagnosis of pneumonia. (moderate recommendation; level iii evidence.) recommended diagnostic tests for etiology. 10 . patients with cap should be investigated for specific pathogens that would significantly alter standard (empirical) management decisions, when the presence of such pathogens is suspected on the basis of clinical and epidemiologic clues. (strong recommendation; level ii evidence.) recommendations for diagnostic testing remain controversial. the overall low yield and infrequent positive impact on clinical care argue against the routine use of common tests, such as blood and sputum cultures. conversely, these cultures may have a major impact on the care of an individual patient and are important for epidemiologic reasons, including the antibiotic susceptibility patterns used to develop treatment guidelines. a list of clinical indications for more extensive diagnostic testing (table 5) was, therefore, developed, primarily on the basis of 2 criteria: (1) when the result is likely to change individual antibiotic management and (2) when the test is likely to have the highest yield. 11 . routine diagnostic tests to identify an etiologic diagnosis are optional for outpatients with cap. (moderate recommendation; level iii evidence.) 12. pretreatment blood samples for culture and an expectorated sputum sample for stain and culture (in patients with a productive cough) should be obtained from hospitalized patients with the clinical indications listed in table 5 but are optional for patients without these conditions. (moderate recommendation; level i evidence.) 13. pretreatment gram stain and culture of expectorated sputum should be performed only if a good-quality specimen can be obtained and quality performance measures for collection, transport, and processing of samples can be met. (moderate recommendation; level ii evidence.) 14. patients with severe cap, as defined above, should at least have blood samples drawn for culture, urinary antigen tests for legionella pneumophila and streptococcus pneumoniae performed, and expectorated sputum samples collected for culture. for intubated patients, an endotracheal aspirate sample should be obtained. (moderate recommendation; level ii evidence.) the most clear-cut indication for extensive diagnostic testing is in the critically ill cap patient. such patients should at least have blood drawn for culture and an endotracheal aspirate obtained if they are intubated; consideration should be given to more extensive testing, including urinary antigen tests for l. pneumophila and s. pneumoniae and gram stain and culture of expectorated sputum in nonintubated patients. for inpatients without the clinical indications listed in table 5, diagnostic testing is optional (but should not be considered wrong). empirical antimicrobial therapy. empirical antibiotic recommendations (table 7) have not changed significantly from those in previous guidelines. increasing evidence has strengthened the recommendation for combination empirical therapy for severe cap. only 1 recently released antibiotic has been added to the recommendations: ertapenem, as an acceptable b-lactam alternative for hospitalized patients with risk factors for infection with gram-negative pathogens other than pseudomonas aeruginosa. at present, the committee is awaiting further evaluation of the safety of telithromycin by the us food and drug administration before making its final recommendation regarding this drug. recommendations are generally for a class of antibiotics rather than for a specific drug, unless outcome data clearly favor one drug. because overall efficacy remains good for many classes of agents, the more potent drugs are given preference because of their benefit in decreasing the risk of selection for antibiotic resistance. 19 . a b-lactam plus a macrolide (strong recommendation; level i evidence) (preferred b-lactam agents include cefotaxime, ceftriaxone, and ampicillin; ertapenem for selected patients; with doxycycline [level iii evidence] as an alternative to the macrolide. a respiratory fluoroquinolone should be used for penicillin-allergic patients.) increasing resistance rates have suggested that empirical therapy with a macrolide alone can be used only for the treat-ment of carefully selected hospitalized patients with nonsevere disease and without risk factors for infection with drug-resistant pathogens. however, such monotherapy cannot be routinely recommended. inpatient, icu treatment 20. a b-lactam (cefotaxime, ceftriaxone, or ampicillin-sulbactam) plus either azithromycin (level ii evidence) or a fluoroquinolone (level i evidence) (strong recommendation) (for penicillin-allergic patients, a respiratory fluoroquinolone and aztreonam are recommended.) 21 . for pseudomonas infection, use an antipneumococcal, antipseudomonal b-lactam (piperacillin-tazobactam, cefepime, imipenem, or meropenem) plus either ciprofloxacin or levofloxacin (750-mg dose) or the above b-lactam plus an aminoglycoside and azithromycin or the above b-lactam plus an aminoglycoside and an antipneumococcal fluoroquinolone (for penicillin-allergic patients, substitute aztreonam for the above b-lactam). (moderate recommendation; level iii evidence.) 22 . for community-acquired methicillin-resistant staphylococcus aureus infection, add vancomycin or linezolid. (moderate recommendation; level iii evidence.) infections with the overwhelming majority of cap pathogens will be adequately treated by use of the recommended empirical regimens. the emergence of methicillin-resistant s. aureus as a cap pathogen and the small but significant incidence of cap due to p. aeruginosa are the exceptions. these pathogens occur in specific epidemiologic patterns and/or with certain clinical presentations, for which empirical antibiotic coverage may be warranted. however, diagnostic tests are likely to be of high yield for these pathogens, allowing early discontinuation of empirical treatment if results are negative. the risk factors are included in the table 5 recommendations for indications for increased diagnostic testing. risk factors for other uncommon etiologies of cap are listed in table 8, and recommendations for treatment are included in table 9 . pathogen-directed therapy. 23 definitions and classification. 38 . the use of a systematic classification of possible causes of failure to respond, based on time of onset and type of failure (table 11) , is recommended. (moderate recommendation; level ii evidence.) as many as 15% of patients with cap may not respond appropriately to initial antibiotic therapy. a systematic approach to these patients (table 11) will help to determine the cause. because determination of the cause of failure is more accurate if the original microbiological etiology is known, risk factors for nonresponse or deterioration (table 12) figure prominently in the list of situations in which more aggressive and/ or extensive initial diagnostic testing is warranted ( [2] . despite advances in antimicrobial therapy, rates of mortality due to pneumonia have not decreased significantly since penicillin became routinely available [3] . groups interested in approaches to the management of cap include professional societies, such as the american thoracic society (ats) and the infectious diseases society of america (idsa); government agencies or their contract agents, such as the center for medicare and medicaid services and the department of veterans affairs; and voluntary accrediting agencies, such as the joint commission on accreditation of healthcare organizations. in addition, external review groups and consumer groups have chosen cap outcomes as major quality indicators. such interest has resulted in numerous guidelines for the management of cap [4] . some of these guidelines represent truly different perspectives, including differences in health care systems, in the availability of diagnostic tools or therapeutic agents, or in either the etiology or the antibiotic susceptibility of common causative microorganisms. the most widely referenced guidelines in the united states have been those published by the ats [5, 6] and the idsa [7] [8] [9] . differences, both real and imagined, between the ats and idsa guidelines have led to confusion for individual physicians, as well as for other groups who use these published guidelines rather than promulgating their own. in response to this concern, the idsa and the ats convened a joint committee to develop a unified cap guideline document. this document represents a consensus of members of both societies, and both governing councils have approved the statement. purpose and scope. the purpose of this document is to update clinicians with regard to important advances and controversies in the management of patients with cap. the committee chose not to address cap occurring in immunocompromised patients, including solid organ, bone marrow, or stem cell transplant recipients; patients receiving cancer chemotherapy or long-term (130 days) high-dose corticosteroid treatment; and patients with congenital or acquired immunodeficiency or those infected with hiv who have cd4 cell counts !350 cells/mm 3 , although many of these patients may be infected with the same microorganisms. pneumonia in children (р18 years of age) is also not addressed. substantial overlap exists among the patients these guidelines address and those discussed in the recently published guidelines for health care-associated pneumonia (hcap) [10] . two issues are pertinent: (1) an increased risk of infection with drugresistant isolates of usual cap pathogens, such as streptococcus pneumoniae, and (2) an increased risk of infection with less common, usually hospital-associated pathogens, such as pseudomonas and acinetobacter species and methicillin-resistant staphylococcus aureus (mrsa). pneumonia in nonambulatory residents of nursing homes and other long-term care facilities epidemiologically mirrors hospital-acquired pneumonia and should be treated according to the hcap guidelines. however, certain other patients whose conditions are included under the designation of hcap are better served by management in ac-cordance with cap guidelines with concern for specific pathogens. for example, long-term dialysis alone is a risk for mrsa infection but does not necessarily predispose patients to infection with other hcap pathogens, such as pseudomonas aeruginosa or acinetobacter species. on the other hand, certain patients with chronic obstructive pulmonary disease (copd) are at greater risk for infection with pseudomonas species but not mrsa. these issues will be discussed in specific sections below. the committee started with the premise that mortality due to cap can be decreased. we, therefore, have placed the greatest emphasis on aspects of the guidelines that have been associated with decreases in mortality. for this reason, the document focuses mainly on management and minimizes discussions of such factors as pathophysiology, pathogenesis, mechanisms of antibiotic resistance, and virulence factors. the committee recognizes that the majority of patients with cap are cared for by primary care, hospitalist, and emergency medicine physicians [11] , and these guidelines are, therefore, directed primarily at them. the committee consisted of infectious diseases, pulmonary, and critical care physicians with interest and expertise in pulmonary infections. the expertise of the committee and the extensive literature evaluation suggest that these guidelines are also an appropriate starting point for consultation by these types of physicians. although much of the literature cited originates in europe, these guidelines are oriented toward the united states and canada. although the guidelines are generally applicable to other parts of the world, local antibiotic resistance patterns, drug availability, and variations in health care systems suggest that modification of these guidelines is prudent for local use. methodology. the process of guideline development started with the selection of committee cochairs by the presidents of the idsa [12] and ats [13] , in consultation with other leaders in the respective societies. the committee cochairs were charged with selection of the rest of the committee. the idsa members were those involved in the development of previous idsa cap guidelines [9] , whereas ats members were chosen in consultation with the leadership of the mycobacteria tuberculosis and pulmonary infection assembly, with input from the chairs of the clinical pulmonary and critical care assemblies. committee members were chosen to represent differing expertise and viewpoints on the various topics. one acknowledged weakness of this document is the lack of representation by primary care, hospitalist, and emergency medicine physicians. the cochairs generated a general outline of the topics to be covered that was then circulated to committee members for input. a conference phone call was used to review topics and to discuss evidence grading and the general aims and expectations of the document. the topics were divided, and committee members were assigned by the cochairs and charged with presentation of their topic at an initial face-to-face meeting, as well as with development of a preliminary document dealing with their topic. controversial topics were assigned to 2 committee members, 1 from each society. an initial face-to-face meeting of a majority of committee members involved presentations of the most controversial topics, including admission decisions, diagnostic strategies, and antibiotic therapy. prolonged discussions followed each presentation, with consensus regarding the major issues achieved before moving to the next topic. with input from the rest of the committee, each presenter and committee member assigned to the less controversial topics prepared an initial draft of their section, including grading of the evidence. iterative drafts of the statement were developed and distributed by e-mail for critique, followed by multiple revisions by the primary authors. a second face-to-face meeting was also held for discussion of the less controversial areas and further critique of the initial drafts. once general agreement on the separate topics was obtained, the cochairs incorporated the separate documents into a single statement, with substantial editing for style and consistency. the document was then redistributed to committee members to review and update with new information from the literature up to june 2006. recommended changes were reviewed by all committee members by e-mail and/or conference phone call and were incorporated into the final document by the cochairs. this document was then submitted to the societies for approval. each society independently selected reviewers, and changes recommended by the reviewers were discussed by the committee and incorporated into the final document. the guideline was then submitted to the idsa governing council and the ats board of directors for final approval. grading of guideline recommendations. initially, the committee decided to grade only the strength of the evidence, using a 3-tier scale (table 1) used in a recent guideline from both societies [10] . in response to reviewers' comments and the maturation of the field of guideline development [14] , a separate grading of the strength of the recommendations was added to the final draft. more extensive and validated criteria, such as grade [14] , were impractical for use at this stage. the 3-tier scale similar to that used in other idsa guideline documents [12] and familiar to many of the committee members was therefore chosen. the strength of each recommendation was graded as "strong," "moderate," or "weak." each committee member independently graded each recommendation on the basis of not only the evidence but also expert interpretation and clinical applicability. the final grading of each recommendation was a composite of the individual committee members' grades. for the final document, a strong recommendation required у6 (of 12) of the members to consider it to be strong and the majority of the others to grade it as moderate. the implication of a strong recommendation is that most patients should receive that intervention. significant variability in the management of patients with cap is well documented. some who use guidelines suggest that this variability itself is undesirable. industrial models suggesting that variability per se is undesirable may not always be relevant to medicine [15] . such models do not account for substantial variability among patients, nor do they account for variable end points, such as limitation of care in patients with end-stage underlying diseases who present with cap. for this reason, the committee members feel strongly that 100% compliance with guidelines is not the desired goal. however, the rationale for variation from a strongly recommended guideline should be apparent from the medical record. conversely, moderate or weak recommendations suggest that, even if a majority would follow the recommended management, many practitioners may not. deviation from guidelines may occur for a variety of reasons [16, 17] . one document cannot cover all of the variable settings, unique hosts, or epidemiologic patterns that may dictate alternative management strategies, and physician judgment should always supersede guidelines. this is borne out by the finding that deviation from guidelines is greatest in the treatment of patients with cap admitted to the icu [18] . in addition, few of the recommendations have level i evidence to support them, and most are, therefore, legitimate topics for future research. subsequent publication of studies documenting that care that deviates from guidelines results in better outcomes will stimulate revision of the guidelines. the committee anticipates that this will occur, and, for this reason, both the ats and idsa leaderships have committed to the revision of these guidelines on a regular basis. we recognize that these guidelines may be used as a measure of quality of care for hospitals and individual practitioners. although these guidelines are evidence based, the committee strongly urges that deviations from them not necessarily be considered substandard care, unless they are accompanied by evidence for worse outcomes in a studied population. 1. locally adapted guidelines should be implemented to improve process of care variables and relevant clinical outcomes. (strong recommendation; level i evidence.) enthusiasm for developing this set of cap guidelines derives, in large part, from evidence that previous cap guidelines have led to improvement in clinically relevant outcomes [17, [19] [20] [21] . protocol design varies among studies, and the preferable randomized, parallel group design has been used in only a small minority. confirmatory studies that use randomized, parallel groups with precisely defined treatments are still needed, but a consistent pattern of benefit is found in the other types of level i studies. documented benefits. published protocols have varied in primary focus and comprehensiveness, and the corresponding benefits vary from one study to another. however, the most impressive aspect of this literature is the consistently beneficial effect seen in some clinically relevant parameter after the introduction of a protocol that increases compliance with published guidelines. a decrease in mortality with the introduction of guidelinebased protocols was found in several studies [19, 21] . a 5-year study of 28,700 patients with pneumonia who were admitted during implementation of a pneumonia guideline demonstrated that the crude 30-day mortality rate was 3.2% lower with the guideline (adjusted or, 0.69; 95% ci, 0.49-0.97) [19] , compared with that among patients treated concurrently by nonaffiliated physicians. after implemention of a practice guideline at one spanish hospital [21] , the survival rate at 30 days was higher (or, 2.14; 95% ci, 1.23-3.72) than at baseline and in comparison with 4 other hospitals without overt protocols. lower mortality was seen in other studies, although the differences were not statistically significant [22, 23] . studies that documented lower mortality emphasized increasing the number of patients receiving guideline-recommended antibiotics, confirming results of the multivariate analysis of a retrospective review [24] . when the focus of a guideline was hospitalization, the number of less ill patients admitted to the hospital was consistently found to be lower. using admission decision support, a prospective study of 11700 emergency department (ed) visits in 19 hospitals randomized between pathway and "conventional" management found that admission rates among low-risk patients at pathway hospitals decreased (from 49% to 31% of patients in pneumonia severity index [psi] classes i-iii; p ! ) without differences in patient satisfaction scores or rate of .01 readmission [20] . calculating the psi score and assigning the risk class, providing oral clarithromycin, and home nursing follow-up significantly ( ) decreased the number of low-p p .01 mortality-risk admissions [25] . however, patient satisfaction among outpatients was lower after implementation of this guideline, despite survey data that suggested most patients would prefer outpatient treatment [26] . of patients discharged from the ed, 9% required hospitalization within 30 days, although another study showed lower readmission rates with the use of a protocol [23] . admission decision support derived from the 1993 ats guideline [5] recommendations, combined with outpatient antibiotic recommendations, reduced the cap hospitalization rate from 13.6% to 6.4% [23] , and admission rates for other diagnoses were unchanged. not surprisingly, the resultant overall cost of care decreased by half ( ). p p .01 protocols using guidelines to decrease the duration of hospitalization have also been successful. guideline implementation in 31 connecticut hospitals decreased the mean length of hospital stay (los) from 7 to 5 days ( ) [27] . an ed-p ! .001 based protocol decreased the mean los from 9.7 to 6.4 days ( ), with the benefits of guideline implementation p ! .0001 maintained 3 years after the initial study [22] . a 7-site trial, randomized by physician group, of guideline alone versus the same guideline with a multifaceted implementation strategy found that addition of an implementation strategy was associated with decreased duration of intravenous antibiotic therapy and los, although neither decrease was statistically significant [28] . several other studies used guidelines to significantly shorten the los, by an average of 11.5 days [20, 21] . markers of process of care can also change with the use of a protocol. the time to first antibiotic dose has been effectively decreased with cap protocols [22, 27, 29] . a randomized, parallel group study introduced a pneumonia guideline in 20 of 36 small oklahoma hospitals [29] , with the identical protocol implemented in the remaining hospitals in a second phase. serial measurement of key process measures showed significant improvement in time to first antibiotic dose and other variables, first in the initial 20 hospitals and later in the remaining 16 hospitals. implementing a guideline in the ed halved the time to initial antibiotic dose [22] . 2. cap guidelines should address a comprehensive set of elements in the process of care rather than a single element in isolation. (strong recommendation; level iii evidence.) common to all of the studies documented above, a comprehensive protocol was developed and implemented, rather than one addressing a single aspect of cap care. no study has documented that simply changing 1 metric, such as time to first antibiotic dose, is associated with a decrease in mortality. elements important in cap guidelines are listed in table 2. of these, rapid and appropriate empirical antibiotic therapy is consistently associated with improved outcome. we have also included elements of good care for general medical inpatients, such as early mobilization [30] and prophylaxis against thromboembolic disease [31] . although local guidelines need not include all elements, a logical constellation of elements should be addressed. in instituting cap protocol guidelines, the outcomes most relevant to the individual center or medical system should be addressed first. unless a desire to change clinically relevant outcomes exists, adherence to guidelines will be low, and institutional resources committed to implement the guideline are likely to be insufficient. guidelines for the treatment of pneumonia must use approaches that differ from current practice and must be successfully implemented before process of care and outcomes can change. for example, rhew et al. [32] designed a guideline to decrease los that was unlikely to change care, because the recommended median los was longer than the existing los for cap at the study hospitals. the difficulty in implementing guidelines and changing physician behavior has also been documented [28, 33] . clinically relevant outcome parameters should be evaluated to measure the effect of the local guideline. outcome parameters that can be used to measure the effect of implementation of a cap guideline within an organization are listed in table 3. just as it is important not to focus on one aspect of care, studying more than one outcome is also important. improvements in one area may be offset by worsening in a related area; for example, decreasing admission of low-acuity patients might increase the number of return visits to the ed or hospital readmissions [25] . almost all of the major decisions regarding management of cap, including diagnostic and treatment issues, revolve around the initial assessment of severity. we have, therefore, organized the guidelines to address this issue first. hospital admission decision. the initial management decision after diagnosis is to determine the site of care-outpatient, hospitalization in a medical ward, or admission to an icu. the decision to admit the patient is the most costly issue in the management of cap, because the cost of inpatient care for pneumonia is up to 25 times greater than that of outpatient care [34] and consumes the majority of the estimated $8.4-$10 billion spent yearly on treatment. other reasons for avoiding unnecessary admissions are that patients at low risk for death who are treated in the outpatient setting are able to resume normal activity sooner than those who are hospitalized, and 80% are reported to prefer outpatient therapy [26, 35] . hospitalization also increases the risk of thromboembolic events and superinfection by more-virulent or resistant hospital bacteria [36] . 4. severity-of-illness scores, such as the curb-65 criteria (confusion, uremia, respiratory rate, low blood pressure, age 65 years or greater), or prognostic models, such as the psi, can be used to identify patients with cap who may be candidates for outpatient treatment. (strong recommendation; level i evidence.) significant variation in admission rates among hospitals and among individual physicians is well documented. physicians often overestimate severity and hospitalize a significant number of patients at low risk for death [20, 37, 38] . because of these issues, interest in objective site-of-care criteria has led to attempts by a number of groups to develop such criteria [39] [40] [41] [42] [43] [44] [45] [46] [47] [48] . the relative merits and limitations of various proposed criteria have been carefully evaluated [49] . the 2 most interesting are the psi [42] and the british thoracic society (bts) criteria [39, 45] . the psi is based on derivation and validation cohorts of 14,199 and 38,039 hospitalized patients with cap, respectively, plus an additional 2287 combined inpatients and outpatients [42] . the psi stratifies patients into 5 mortality risk classes, and its ability to predict mortality has been confirmed in multiple subsequent studies. on the basis of associated mortality rates, it has been suggested that risk class i and ii patients should be treated as outpatients, risk class iii patients should be treated in an observation unit or with a short hospitalization, and risk class iv and v patients should be treated as inpatients [42] . yealy et al. [50] conducted a cluster-randomized trial of low-, moderate-, and high-intensity processes of guideline implementation in 32 eds in the united states. their guideline used the psi for admission decision support and included recommendations for antibiotic therapy, timing of first antibiotic dose, measurement of oxygen saturation, and blood cultures for admitted patients. eds with moderate-to high-intensity guideline implementation demonstrated more outpatient treatment of low-risk patients and higher compliance with antibiotic recommendations. no differences were found in mortality rate, rate of hospitalization, median time to return to work or usual activities, or patient satisfaction. this study differs from those reporting a mortality rate difference [19, 21] in that many hospitalized patients with pneumonia were not included. in addition, eds with low-intensity guideline implementation formed the comparison group, rather than eds practicing nonguideline, usual pneumonia care. the bts original criteria of 1987 have subsequently been modified [39, 51] . in the initial study, risk of death was increased 21-fold if a patient, at the time of admission, had at least 2 of the following 3 conditions: tachypnea, diastolic hypotension, and an elevated blood urea nitrogen (bun) level. these criteria appear to function well except among patients with underlying renal insufficiency and among elderly patients [52, 53] . the most recent modification of the bts criteria includes 5 easily measurable factors [45] . multivariate analysis of 1068 patients identified the following factors as indicators of increased mortality: confusion (based on a specific mental test or disorientation to person, place, or time), bun level 17 mmol/l (20 mg/dl), respiratory rate у30 breaths/min, low blood pressure (systolic, !90 mm hg; or diastolic, р60 mm hg), and age у65 years; this gave rise to the acronym curb-65. in the derivation and validation cohorts, the 30-day mortality among patients with 0, 1, or 2 factors was 0.7%, 2.1%, and 9.2%, respectively. mortality was higher when 3, 4, or 5 factors were present and was reported as 14.5%, 40%, and 57%, respectively. the authors suggested that patients with a curb-65 score of 0-1 be treated as outpatients, that those with a score of 2 be admitted to the wards, and that patients with a score of у3 often required icu care. a simplified version (crb-65), which does not require testing for bun level, may be appropriate for decision making in a primary care practitioner's office [54] . the use of objective admission criteria clearly can decrease the number of patients hospitalized with cap [20, 23, 25, 55] . whether the psi or the curb-65 score is superior is unclear, because no randomized trials of alternative admission criteria exist. when compared in the same population, the psi classified a slightly larger percentage of patients with cap in the lowrisk categories, compared with the curb or curb-65 criteria, while remaining associated with a similar low mortality rate among patients categorized as low risk [56] . several factors are important in this comparison. the psi includes 20 different variables and, therefore, relies on the availability of scoring sheets, limiting its practicality in a busy ed [55] . in contrast, the curb-65 criteria are easily remembered. however, curb-65 has not been as extensively studied as the psi, especially with prospective validation in other patient populations (e.g., the indigent inner-city population), and has not been specifically studied as a means of reducing hospital admission rates. in eds with sufficient decision support resources (either human or computerized), the benefit of greater experience with the psi score may favor its use for screening patients who may be candidates for outpatient management [50, [57] [58] [59] . 5 . objective criteria or scores should always be supplemented with physician determination of subjective factors, including the ability to safely and reliably take oral medication and the availability of outpatient support resources. (strong recommendation; level ii evidence.) studies show that certain patients with low psi or curb-65 scores [20, 60, 61] require hospital admission, even to the icu [49, 62, 63] . both scores depend on certain assumptions. one is that the main rationale for admission of a patient with cap is risk of death. this assumption is clearly not valid in all cases. another is that the laboratory and vital signs used for scoring are stable over time rather than indicative of transient abnormalities. this is also not true in all cases. therefore, dynamic assessment over several hours of observation may be more accurate than a score derived at a single point in time. although advantageous to making decisions regarding hospital admission, sole reliance on a score for the hospital admission decision is unsafe. reasons for the admission of low-mortality-risk patients fall into 4 categories: (1) complications of the pneumonia itself, (2) exacerbation of underlying diseases(s), (3) inability to reliably take oral medications or receive outpatient care, and/or (4) multiple risk factors falling just above or below thresholds for the score [62] . use of the psi score in clinical trials has demonstrated some of its limitations, which may be equally applicable to other scoring techniques. a modification of the original psi score was needed when it was applied to the admission decision. an arterial saturation of !90% or an arterial oxygen pressure (pao 2 ) of !60 mm hg as a complication of the pneumonia, was added as a sole indicator for admission for patients in risk classes i-iii as an added "margin of safety" in one trial [42] . in addition to patients who required hospital admission because of hypoxemia, a subsequent study identified patients in low psi risk classes (i-iii) who needed hospital admission because of shock, decompensated coexisting illnesses, pleural effusion, inability to maintain oral intake, social problems (the patient was dependent or no caregiver was available), and lack of response to previous adequate empirical antibiotic therapy [64] . of 178 patients in low psi risk classes who were treated as inpatients, 106 (60%) presented with at least 1 of these factors. other medical or psychosocial needs requiring hospital care include intractable vomiting, injection drug abuse, severe psychiatric illness, homelessness, poor overall functional status [65] , and cognitive dysfunction [61, 66] . the psi score is based on a history of diseases that increase risk of death, whereas the curb-65 score does not directly address underlying disease. however, pneumonia may exacerbate an underlying disease, such as obstructive lung disease, congestive heart failure, or diabetes mellitus, which, by themselves, may require hospital admission [60, 67] . atlas et al. [25] were able to reduce hospital admissions among patients in psi risk classes i-iii from 58% in a retrospective control group to 43% in a psi-based intervention group. ten of 94 patients in the latter group (compared with 0 patients in the control population) were subsequently admitted, several for reasons unrelated to their pneumonia. also, the presence of rare illnesses, such as neuromuscular or sickle cell disease, may require hospitalization but not affect the psi score. the necessary reliance on dichotomous predictor variables (abnormal vs. normal) in most criteria and the heavy reliance on age as a surrogate in the psi score may oversimplify their use for admission decisions. for example, a previously healthy 25-year-old patient with severe hypotension and tachycardia and no additional pertinent prognostic factors would be placed in risk class ii, whereas a 70-year-old man with a history of localized prostate cancer diagnosed 10 months earlier and no other problems would be placed in risk class iv [42] . finally, patient satisfaction was lower among patients treated outside the hospital in one study with a psi-based intervention group [25] , suggesting that the savings resulting from use of the psi may be overestimated and that physicians should consider additional factors not measured by the psi. 6. for patients with curb-65 scores у2, more-intensive treatment-that is, hospitalization or, where appropriate and available, intensive in-home health care services-is usually warranted. (moderate recommendation; level iii evidence.) although the psi and curb-65 criteria are valuable aids in avoiding inappropriate admissions of low-mortality-risk patients, another important role of these criteria may be to help identify patients at high risk who would benefit from hospitalization. the committee preferred the curb-65 criteria because of ease of use and because they were designed to measure illness severity more than the likelihood of mortality. patients with a curb-65 score у2 are not only at increased risk of death but also are likely to have clinically important physiologic derangements requiring active intervention. these patients should usually be considered for hospitalization or for aggressive in-home care, where available. in a cohort of ∼3000 patients, the mortality with a curb-65 score of 0 was only 1.2%, whereas 3-4 points were associated with 31% mortality [45] . because the psi score is not based as directly on severity of illness as are the curb-65 criteria, a threshold for patients who would require hospital admission or intensive outpatient treatment is harder to define. the higher the score, the greater the need for hospitalization. however, even a patient who meets criteria for risk class v on the basis of very old age and multiple stable chronic illnesses may be successfully managed as an outpatient [23] . 7. direct admission to an icu is required for patients with septic shock requiring vasopressors or with acute respiratory failure requiring intubation and mechanical ventilation. (strong recommendation; level ii evidence.) the second-level admission decision is whether to place the patient in the icu or a high-level monitoring unit rather than on a general medical floor. approximately 10% of hospitalized patients with cap require icu admission [68] [69] [70] , but the indications vary strikingly among patients, physicians, hospitals, and different health care systems. some of the variability among institutions results from the availability of high-level monitoring or intermediate care units appropriate for patients at increased risk of complications. because respiratory failure is the major reason for delayed transfer to the icu, simple cardiac monitoring units would not meet the criteria for a highlevel monitoring unit for patients with severe cap. one of the most important determinants of the need for icu care is the presence of chronic comorbid conditions [68] [69] [70] [71] [72] . however, approximately one-third of patients with severe cap were previously healthy [73] . the rationale for specifically defining severe cap is 4-fold: • appropriate placement of patients optimizes use of limited icu resources. • transfer to the icu for delayed respiratory failure or delayed onset of septic shock is associated with increased mortality [74] . although low-acuity icu admissions do occur, the major concern is initial admission to the general medical unit, with subsequent transfer to the icu. as many as 45% of patients with cap who ultimately require icu admission were initially admitted to a non-icu setting [75] . many delayed transfers to the icu represent rapidly progressive pneumonia that is not obvious on admission. however, some have subtle findings, including those included in the minor criteria in table 4, which might warrant direct admission to the icu. • the distribution of microbial etiologies differs from that of cap in general [76] [77] [78] [79] , with significant implications for diagnostic testing and empirical antibiotic choices. avoidance of inappropriate antibiotic therapy has also been associated with lower mortality [80, 81] . • patients with cap appropriate for immunomodulatory treatment must be identified. the systemic inflammatory response/severe sepsis criteria typically used for generic sepsis trials may not be adequate when applied specifically to severe cap [82] . for example, patients with unilateral lobar pneumonia may have hypoxemia severe enough to meet criteria for acute lung injury but not have a systemic response. several criteria have been proposed to define severe cap. most case series have defined it simply as cap that necessitates icu admission. objective criteria to identify patients for icu admission include the initial ats definition of severe cap [5] and its subsequent modification [6, 82] , the curb criteria [39, 45] , and psi severity class v (or iv and v) [42] . however, none of these criteria has been prospectively validated for the icu admission decision. recently, these criteria were retrospectively evaluated in a cohort of patients with cap admitted to the icu [63] . all were found to be both overly sensitive and nonspecific in comparison with the original clinical decision to admit to the icu. revisions of the criteria or alternative criteria were, therefore, recommended. for the revised criteria, the structure of the modified ats criteria for severe cap was retained [6] . the 2 major criteriamechanical ventilation with endotracheal intubation and septic shock requiring vasopressors-are absolute indications for admission to an icu. in contrast, the need for icu admission is less straightforward for patients who do not meet the major criteria. on the basis of the published operating characteristics of the criteria, no single set of minor criteria is adequate to define severe cap. both the ats minor criteria [75] and the curb criteria [45] have validity when predicting which patients will be at increased risk of death. therefore, the ats minor criteria and the curb variables were included in the new proposed minor criteria (table 4) . age, by itself, was not felt to be an appropriate factor for the icu admission decision, but the remainder of the curb-65 criteria [45] were retained as minor criteria (with the exception of hypotension requiring vasopressors as a major criterion). rather than the complex criteria for confusion in the original curb studies, the definition of confusion should be new-onset disorientation to person, place, or time. three additional minor criteria were added. leukopenia (white blood cell count, !4000 cells/mm 3 ) resulting from cap has consistently been associated with excess mortality, as well as with an increased risk of complications such as acute respiratory distress syndrome (ards) [77, 79, [83] [84] [85] [86] [87] . in addition, leukopenia is seen not only in bacteremic pneumococcal disease but also in gram-negative cap [88, 89] . when leukopenia occurs in patients with a history of alcohol abuse, the adverse manifestations of septic shock and ards may be delayed or masked. therefore, these patients were thought to benefit from icu monitoring. the coagulation system is often activated in cap, and development of thrombocytopenia (platelet count, !100,000 cells/mm 3 ) is also associated with a worse prognosis [86, [90] [91] [92] . nonexposure hypothermia (core temperature, !36њc) also carries an ominous prognosis in cap [83, 93] . the committee felt that there was sufficient justification for including these additional factors as minor criteria. other factors associated with increased mortality due to cap were also considered, including acute alcohol ingestion and delirium tremens [79, 85, 94] , hypoglycemia and hyperglycemia, occult metabolic acidosis or elevated lactate levels [91] , and hyponatremia [95] . however, many of these criteria overlap with those selected. future studies validating the proposed criteria should record these factors as well, to determine whether addition or substitution improves the predictive value of our proposed criteria. with the addition of more minor criteria, the threshold for icu admission was felt to be the presence of at least 3 minor criteria, based on the mortality association with the curb criteria. selecting 2 criteria appears to be too nonspecific, as is demonstrated by the initial ats criteria [5] . whether each of the criteria is of equal weight is also not clear. therefore, prospective validation of this set of criteria is clearly needed. 9. in addition to a constellation of suggestive clinical features, a demonstrable infiltrate by chest radiograph or other imaging technique, with or without supporting microbiological data, is required for the diagnosis of pneumonia. (moderate recommendation; level iii evidence.) the diagnosis of cap is based on the presence of select clinical features (e.g., cough, fever, sputum production, and pleuritic chest pain) and is supported by imaging of the lung, usually by chest radiography. physical examination to detect rales or bronchial breath sounds is an important component of the evaluation but is less sensitive and specific than chest radiographs [96] . both clinical features and physical exam findings may be lacking or altered in elderly patients. all patients should be screened by pulse oximetry, which may suggest both the presence of pneumonia in patients without obvious signs of pneumonia and unsuspected hypoxemia in patients with diagnosed pneumonia [42, 97, 98] . a chest radiograph is required for the routine evaluation of patients who are likely to have pneumonia, to establish the diagnosis and to aid in differentiating cap from other common causes of cough and fever, such as acute bronchitis. chest radiographs are sometimes useful for suggesting the etiologic agent, prognosis, alternative diagnoses, and associated conditions. rarely, the admission chest radiograph is clear, but the patient's toxic appearance suggests more than bronchitis. ct scans may be more sensitive, but the clinical significance of these findings when findings of radiography are negative is unclear [99] . for patients who are hospitalized for suspected pneumonia but who have negative chest radiography findings, it may be reasonable to treat their condition presumptively with antibiotics and repeat the imaging in 24-48 h. microbiological studies may support the diagnosis of pneumonia due to an infectious agent, but routine tests are frequently falsely negative and are often nonspecific. a history of recent travel or endemic exposure, if routinely sought, may identify specific potential etiologies that would otherwise be unexpected as a cause of cap (see table 8 ) [100] . 10. patients with cap should be investigated for specific pathogens that would significantly alter standard (empirical) management decisions, when the presence of such pathogens is suspected on the basis of clinical and epidemiologic clues. (strong recommendation; level ii evidence.) the need for diagnostic testing to determine the etiology of cap can be justified from several perspectives. the primary reason for such testing is if results will change the antibiotic management for an individual patient. the spectrum of antibiotic therapy can be broadened, narrowed, or completely altered on the basis of diagnostic testing. the alteration in therapy that is potentially most beneficial to the individual is an escalation or switch of the usual empirical regimen because of unusual pathogens (e.g., endemic fungi or mycobacterium tuberculosis) or antibiotic resistance issues. broad empirical coverage, such as that recommended in these guidelines, would not provide the optimal treatment for certain infections, such as psittacosis or tularemia. increased mortality [80] and increased risk of clinical failure [81, 101] are more common with inappropriate antibiotic therapy. management of initial antibiotic failure is greatly facilitated by an etiologic diagnosis at admission. de-escalation or narrowing of antibiotic therapy on the basis of diagnostic testing is less likely to decrease an individual's risk of death but may decrease cost, drug adverse effects, and antibiotic resistance pressure. some etiologic diagnoses have important epidemiologic implications, such as documentation of severe acute respiratory syndrome (sars), influenza, legionnaires disease, or agents of bioterrorism. diagnostic testing for these infections may affect not only the individual but also many other people. although pneumonia etiologies that should be reported to public health officials vary by state, in general, most states' health regulations require reporting of legionnaires disease, sars, psittacosis, avian influenza (h5n1), and possible agents of bioterrorism (plague, tularemia, and anthrax). in addition, specific diagnostic testing and reporting are important for pneumonia cases of any etiology thought to be part of a cluster or caused by pathogens not endemic to the area. there are also societal reasons for encouraging diagnostic testing. the antibiotic recommendations in the present guidelines are based on culture results and sensitivity patterns from patients with positive etiologic diagnoses [102] . without the accumulated information available from these culture results, trends in antibiotic resistance are more difficult to track, and empirical antibiotic recommendations are less likely to be accurate. the main downside of extensive diagnostic testing of all patients with cap is cost, which is driven by the poor quality of most sputum microbiological samples and the low yield of positive culture results in many groups of patients with cap. a clear need for improved diagnostic testing in cap, most likely using molecular methodology rather than culture, has been recognized by the national institutes of health [103] . the cost-benefit ratio is even worse when antibiotic therapy is not streamlined when possible [104, 105] or when inappropriate escalation occurs [95] . in clinical practice, narrowing of antibiotic therapy is, unfortunately, unusual, but the committee strongly recommends this as best medical practice. the possibility of polymicrobial cap and the potential benefit of combination therapy for bacteremic pneumococcal pneumonia have complicated the decision to narrow antibiotic therapy. delays in starting antibiotic therapy that result from the need to obtain specimens, complications of invasive diagnostic procedures, and unneeded antibiotic changes and additional testing for false-positive tests are also important considerations. the general recommendation of the committee is to strongly encourage diagnostic testing whenever the result is likely to change individual antibiotic management. for other patients with cap, the recommendations for diagnostic testing focus on patients in whom the diagnostic yield is thought to be greatest. these 2 priorities often overlap. recommendations for patients in whom routine diagnostic testing is indicated for the above reasons are listed in retrospective studies of outpatient cap management usually show that diagnostic tests to define an etiologic pathogen are infrequently performed, yet most patients do well with empir-ical antibiotic treatment [42, 106] . exceptions to this general rule may apply to some pathogens important for epidemiologic reasons or management decisions. the availability of rapid point-of-care diagnostic tests, specific treatment and chemoprevention, and epidemiologic importance make influenza testing the most logical. influenza is often suspected on the basis of typical symptoms during the proper season in the presence of an epidemic. however, respiratory syncytial virus (rsv) can cause a similar syndrome and often occurs in the same clinical scenario [107] . rapid diagnostic tests may be indicated when the diagnosis is uncertain and when distinguishing influenza a from influenza b is important for therapeutic decisions. other infections that are important to verify with diagnostic studies because of epidemiologic implications or because they require unique therapeutic intervention are sars and avian (h5n1) influenza, disease caused by agents of bioterrorism, legionella infection, community-acquired mrsa (ca-mrsa) infection, m. tuberculosis infection, or endemic fungal infection. attempts to establish an etiologic diagnosis are also appropriate in selected cases associated with outbreaks, specific risk factors, or atypical presentations. 12. pretreatment blood samples for culture and an expectorated sputum sample for stain and culture (in patients with a productive cough) should be obtained from hospitalized patients with the clinical indications listed in the only randomized controlled trial of diagnostic strategy in cap has demonstrated no statistically significant differences in mortality rate or los between patients receiving pathogendirected therapy and patients receiving empirical therapy [108] . however, pathogen-directed therapy was associated with lower mortality among the small number of patients admitted to the icu. the study was performed in a country with a low incidence of antibiotic resistance, which may limit its applicability to areas with higher levels of resistance. adverse effects were significantly more common in the empirical therapy group but may have been unique to the specific antibiotic choice (erythromycin). the lack of benefit overall in this trial should not be interpreted as a lack of benefit for an individual patient. therefore, performing diagnostic tests is never incorrect or a breach of the standard of care. however, information from cohort and observational studies may be used to define patient groups in which the diagnostic yield is increased. patient groups in which routine diagnostic testing is indicated and the recommended tests are listed in table 5. blood cultures. pretreatment blood cultures yielded positive results for a probable pathogen in 5%-14% in large series of nonselected patients hospitalized with cap [104, 105, [109] [110] [111] . the yield of blood cultures is, therefore, relatively low (although it is similar to yields in other serious infections), and, when management decisions are analyzed, the impact of positive blood cultures is minor [104, 105] . the most common blood culture isolate in all cap studies is s. pneumoniae. because this bacterial organism is always considered to be the most likely pathogen, positive blood culture results have not clearly led to better outcomes or improvements in antibiotic selection [105, 112] . false-positive blood culture results are associated with prolonged hospital stay, possibly related to changes in management based on preliminary results showing gram-positive cocci, which eventually prove to be coagulasenegative staphylococci [95, 109] . in addition, false-positive blood culture results have led to significantly more vancomycin use [95] . for these reasons, blood cultures are optional for all hospitalized patients with cap but should be performed selectively (table 5). the yield for positive blood culture results is halved by prior antibiotic therapy [95] . therefore, when performed, samples for blood culture should be obtained before antibiotic administration. however, when multiple risk factors for bacteremia are present, blood culture results after initiation of antibiotic therapy are still positive in up to 15% of cases [95] and are, therefore, still warranted in these cases, despite the lower yield. the strongest indication for blood cultures is severe cap. patients with severe cap are more likely to be infected with pathogens other than s. pneumoniae, including s. aureus, p. aeruginosa, and other gram-negative bacilli [77-80, 95, 113, 114] . many of the factors predictive of positive blood culture results [95] overlap with risk factors for severe cap (table 4) . therefore, blood cultures are recommended for all patients with severe cap because of the higher yield, the greater possibility of the presence of pathogens not covered by the usual empirical antibiotic therapy, and the increased potential to affect antibiotic management. blood cultures are also indicated when patients have a host defect in the ability to clear bacteremia-for example, as a result of asplenia or complement deficiencies. patients with chronic liver disease also are more likely to have bacteremia with cap [95] . leukopenia is also associated with a high incidence of bacteremia [79, 95] . respiratory tract specimen gram stain and culture. the yield of sputum bacterial cultures is variable and strongly influenced by the quality of the entire process, including specimen collection, transport, rapid processing, satisfactory use of cytologic criteria, absence of prior antibiotic therapy, and skill in interpretation. the yield of s. pneumoniae, for example, is only 40%-50% from sputum cultures from patients with bacteremic pneumococcal pneumonia in studies performed a few decades ago [115, 116] . a more recent study of 100 cases of bacteremic pneumococcal pneumonia found that sputum specimens were not submitted in 31% of cases and were judged as inadequate in another 16% of cases [117] . when patients receiving antibiotics for 124 h were excluded, gram stain showed pneumococci in 63% of sputum specimens, and culture results were positive in 86%. for patients who had received no antibiotics, the gram stain was read as being consistent with pneumococci in 80% of cases, and sputum culture results were positive in 93%. although there are favorable reports of the utility of gram stain [118] , a meta-analysis showed a low yield, considering the number of patients with adequate specimens and definitive results [119] . recent data show that an adequate specimen with a predominant morphotype on gram stain was found in only 14% of 1669 hospitalized patients with cap [120] . higher psi scores did not predict higher yield. however, a positive gram stain was highly predictive of a subsequent positive culture result. the benefit of a sputum gram stain is, therefore, 2-fold. first, it broadens initial empirical coverage for less common etiologies, such as infection with s. aureus or gram-negative organisms. this indication is probably the most important, because it will lead to less inappropriate antibiotic therapy. second, it can validate the subsequent sputum culture results. forty percent or more of patients are unable to produce any sputum or to produce sputum in a timely manner [108, 120] . the yield of cultures is substantially higher with endotracheal aspirates, bronchoscopic sampling, or transthoracic needle aspirates [120] [121] [122] [123] [124] [125] [126] , although specimens obtained after initiation of antibiotic therapy are unreliable and must be interpreted carefully [120, 127, 128] . interpretation is improved with quantitative cultures of respiratory secretions from any source (sputum, tracheal aspirations, and bronchoscopic aspirations) or by interpretation based on semiquantitative culture results [122, 123, 129] . because of the significant influence on diagnostic yield and cost effectiveness, careful attention to the details of specimen handling and processing are critical if sputum cultures are obtained. because the best specimens are collected and processed before antibiotics are given, the time to consider obtaining expectorated sputum specimens from patients with factors listed in table 5 is before initiation of antibiotic therapy. once again, the best indication for more extensive respiratory tract cultures is severe cap. gram stain and culture of endotracheal aspirates from intubated patients with cap produce different results than expectorated sputum from non-icu patients [76, 120] . many of the pathogens in the broader microbiological spectrum of severe cap are unaffected by a single dose of antibiotics, unlike s. pneumoniae. in addition, an endotracheal aspirate does not require patient cooperation, is clearly a lower respiratory tract sample, and is less likely to be contaminated by oropharyngeal colonizers. nosocomial tracheal colonization is not an issue if the sample is obtained soon after intubation. therefore, culture and gram stain of endotracheal aspirates are recommended for patients intubated for severe cap. in addition to routine cultures, a specific request for culture of respiratory secretions on buffered charcoal yeast extract agar to isolate legionella species may be useful in this subset of patients with severe cap in areas where legionella is endemic, as well as in patients with a recent travel history [130] . the fact that a respiratory tract culture result is negative does not mean that it has no value. failure to detect s. aureus or gram-negative bacilli in good-quality specimens is strong evidence against the presence of these pathogens. growth inhibition by antibiotics is lower with these pathogens than with s. pneumoniae, but specimens obtained after initiation of antibiotic therapy are harder to interpret, with the possibility of colonization. necrotizing or cavitary pneumonia is a risk for ca-mrsa infection, and sputum samples should be obtained in all cases. negative gram stain and culture results should be adequate to withhold or stop treatment for mrsa infection. severe copd and alcoholism are major risk factors for infection with p. aeruginosa and other gram-negative pathogens [131] . once again, gram stain and culture of an adequate sputum specimen are usually adequate to exclude the need for empirical coverage of these pathogens. a sputum culture in patients with suspected legionnaires disease is important, because the identification of legionella species implies the possibility of an environmental source to which other susceptible individuals may be exposed. localized community outbreaks of legionnaires disease might be recognized by clinicians or local health departments because у2 patients might be admitted to the same hospital. however, outbreaks of legionnaires disease associated with hotels or cruise ships [132] [133] [134] are rarely detected by individual clinicians, because travelers typically disperse from the source of infection before developing symptoms. therefore, a travel history should be actively sought from patients with cap, and legionella testing should be performed for those who have traveled in the 2 weeks before the onset of symptoms. urinary antigen tests may be adequate to diagnose and treat an individual, but efforts to obtain a sputum specimen for culture are still indicated to facilitate epidemiologic tracking. the availability of a culture isolate of legionella dramatically improves the likelihood that an environmental source of legionella can be identified and remediated [135] [136] [137] . the yield of sputum culture is increased to 43%-57% when associated with a positive urinary antigen test result [138, 139] . attempts to obtain a sample for sputum culture from a patient with a positive pneumococcal urinary antigen test result may be indicated for similar reasons. patients with a productive cough and positive urinary antigen test results have positive sputum culture results in as many as 40%-80% of cases [140] [141] [142] [143] . in these cases, not only can sensitivity testing confirm the appropriate choice for the individual patient, but important data regarding local community antibiotic resistance rates can also be acquired. other cultures. patients with pleural effusions 15 cm in height on a lateral upright chest radiograph [111] should undergo thoracentesis to yield material for gram stain and culture for aerobic and anaerobic bacteria. the yield with pleural fluid cultures is low, but the impact on management decisions is substantial, in terms of both antibiotic choice and the need for drainage. nonbronchoscopic bronchoalveolar lavage (bal) in the ed has been studied in a small, randomized trial of intubated patients with cap [144] . a high percentage (87%) of nonbronchoscopic bal culture results were positive, even in some patients who had already received their first dose of antibiotics. unfortunately, tracheal aspirates were obtained from only a third of patients in the control group, but they all were culture positive. therefore, it is unclear that endotracheal aspirates are inferior to nonbronchoscopic bal. the use of bronchoscopic bal, protected specimen brushing, or transthoracic lung aspiration has not been prospectively studied for initial management of patients with cap [123] . the best indications are for immunocompromised patients with cap or for patients with cap in whom therapy failed [101, 145] . antigen tests. urinary antigen tests are commercially available and have been cleared by the us food and drug administration (fda) for detection of s. pneumoniae and l. pneumophila serogroup 1 [138, 140, [146] [147] [148] [149] . urinary antigen testing appears to have a higher diagnostic yield in patients with more severe illness [139, 140] . for pneumococcal pneumonia, the principal advantages of antigen tests are rapidity (∼15 min), simplicity, reasonable specificity in adults, and the ability to detect pneumococcal pneumonia after antibiotic therapy has been started. studies in adults show a sensitivity of 50%-80% and a specificity of 190% [146, 149, 150] . this is an attractive test for detecting pneumococcal pneumonia when samples for culture cannot be obtained in a timely fashion or when antibiotic therapy has already been initiated. serial specimens from patients with known bacteremia were still positive for pneumococcal urinary antigen in 83% of cases after 3 days of therapy [147] . comparisons with gram stain show that these 2 rapidly available tests often do not overlap, with only 28% concordance (25 of 88) among patients when results of either test were positive [140] . only ∼50% of binax pneumococcal urinary antigen-positive patients can be diagnosed by conventional methods [140, 150] . disadvantages include cost (approximately $30 per specimen), although this is offset by increased diagnosis-related group-based reimbursement for coding for pneumococcal pneumonia, and the lack of an organism for in vitro susceptibility tests. falsepositive results have been seen in children with chronic respiratory diseases who are colonized with s. pneumoniae [151] and in patients with an episode of cap within the previous 3 months [152] , but they do not appear to be a significant problem in colonized patients with copd [140, 152] . for legionella, several urinary antigen assays are available, but all detect only l. pneumophila serogroup 1. although this particular serogroup accounts for 80%-95% of communityacquired cases of legionnaires disease [138, 153] in many areas of north america, other species and serogroups predominate in specific locales [154, 155] . prior studies of culture-proven legionnaires disease indicate a sensitivity of 70%-90% and a specificity of nearly 99% for detection of l. pneumophila serogroup 1. the urine is positive for antigen on day 1 of illness and continues to be positive for weeks [138, 150] . the major issue with urinary bacterial antigen detection is whether the tests allow narrowing of empirical antibiotic therapy to a single specific agent. the recommended empirical antibiotic regimens will cover both of these microorganisms. results of a small observational study suggest that therapy with a macrolide alone is adequate for hospitalized patients with cap who test positive for l. pneumophila urinary antigen [156] . further research is needed in this area. in contrast, rapid antigen detection tests for influenza, which can also provide an etiologic diagnosis within 15-30 min, can lead to consideration of antiviral therapy. test performance varies according to the test used, sample type, duration of illness, and patient age. most show a sensitivity of 50%-70% in adults and a specificity approaching 100% [157] [158] [159] . advantages include the high specificity, the ability of some assays to distinguish between influenza a and b, the rapidity with which the results can be obtained, the possibly reduced use of antibacterial agents, and the utility of establishing this diagnosis for epidemiologic purposes, especially in hospitalized patients who may require infection control precautions. disadvantages include cost (approximately $30 per specimen), high rates of false-negative test results, false-positive assays with adenovirus infections, and the fact that the sensitivity is not superior to physician judgment among patients with typical symptoms during an influenza epidemic [157, 158, 160] . direct fluorescent antibody tests are available for influenza and rsv and require ∼2 h. for influenza virus, the sensitivity is better than with the point-of-care tests (85%-95%). they will detect animal subtypes such as h5n1 and, thus, may be preferred for hospitalized patients [161, 162] . for rsv, direct fluorescent antibody tests are so insensitive (sensitivity, 20%-30%) in adults that they are rarely of value [163] . acute-phase serologic testing. the standard for diagnosis of infection with most atypical pathogens, including chlamydophila pneumoniae, mycoplasma pneumoniae, and legionella species other than l. pneumophila, relies on acute-and convalescent-phase serologic testing. most studies use a microimmunofluorescence serologic test, but this test shows poor reproducibility [164] . management of patients on the basis of a single acute-phase titer is unreliable [165] , and initial antibiotic therapy will be completed before the earliest time point to check a convalescent-phase specimen. a new pcr test (bd probetec et legionella pneumophila; becton dickinson) that will detect all serotypes of l. pneumophila in sputum is now cleared by the fda, but extensive published clinical experience is lacking. most pcr reagents for other respiratory pathogens (except mycobacterium species) are "home grown," with requirements for use based on compliance with nccls criteria for analytical validity [166] . despite the increasing use of these tests for atypical pathogens [167, 168] , a 2001 review by the centers for disease control and prevention (cdc) of diagnostic assays for detection of c. pneumoniae indicated that, of the 18 pcr reagents, only 4 satisfied the criteria for a validated test [166] . the diagnostic criteria defined in this review are particularly important for use in prospective studies of cap, because most prior reports used liberal criteria, which resulted in exaggerated rates. for sars, several pcr assays have been developed, but these tests are inadequate because of high rates of false-negative assays in early stages of infection [169, 170] . a major goal of therapy is eradication of the infecting organism, with resultant resolution of clinical disease. as such, antimicrobials are a mainstay of treatment. appropriate drug selection is dependent on the causative pathogen and its antibiotic susceptibility. acute pneumonia may be caused by a wide variety of pathogens (table 6) . however, until more accurate and rapid diagnostic methods are available, the initial treatment for most patients will remain empirical. recommendations for therapy (table 7) apply to most cases; however, physicians should consider specific risk factors for each patient (table 8) . a syndromic approach to therapy (under the assumption that an etiology correlates with the presenting clinical manifestations) is not specific enough to reliably predict the etiology of cap [172] [173] [174] . even if a microbial etiology is identified, debate continues with regard to pathogen-specific treatment, because recent studies suggest coinfection by atypical pathogens (such as c. pneumoniae, legionella species, and viruses) and more traditional bacteria [120, 175] . however, the importance of treating multiple infecting organisms has not been firmly established. the majority of antibiotics released in the past several decades have an fda indication for cap, making the choice of antibiotics potentially overwhelming. selection of antimicrobial regimens for empirical therapy is based on prediction of the most likely pathogen(s) and knowledge of local susceptibility patterns. recommendations are generally for a class of antibiotics rather than a specific drug, unless outcome data clearly favor one drug. because overall efficacy remains good for many classes of agents, the more potent drugs are given preference because of their benefit in decreasing the risk of selection for antibiotic resistance. other factors for consideration of specific antimicrobials include pharmacokinetics/pharmacodynamics, compliance, safety, and cost. although cap may be caused by a myriad of pathogens, a limited number of agents are responsible for most cases. the emergence of newly recognized pathogens, such as the novel sars-associated coronavirus [170] , continually increases the challenge for appropriate management. table 6 lists the most common causes of cap, in decreasing order of frequency of occurrence and stratified for severity of illness as judged by site of care (ambulatory vs. hospitalized). s. pneumoniae is the most frequently isolated pathogen. other bacterial causes include nontypeable haemophilus influenzae and moraxella catarrhalis, generally in patients who have underlying bronchopulmonary disease, and s. aureus, especially during an influenza outbreak. risks for infection with enterobacteriaceae species and p. aeruginosa as etiologies for cap are chronic oral steroid administration or severe underlying bronchopulmonary disease, alcoholism, and frequent antibiotic therapy [79, 131] , whereas recent hospitalization would define cases as hcap. less common causes of pneumonia include, but are by no means limited to, streptococcus pyogenes, neisseria meningitidis, pasteurella multocida, and h. influenzae type b. the "atypical" organisms, so called because they are not detectable on gram stain or cultivatable on standard bacteriologic media, include m. pneumoniae, c. pneumoniae, legionella species, and respiratory viruses. with the exception of legionella species, these microorganisms are common causes of pneumonia, especially among outpatients. however, these pathogens are not often identified in clinical practice because, with a few exceptions, such as l. pneumophila and influenza virus, no specific, rapid, or standardized tests for their detection exist. although influenza remains the predominant viral cause of cap in adults, other commonly recognized viruses include rsv [107] , adenovirus, and parainfluenza virus, as well as less common viruses, including human metapneumovirus, herpes simplex virus, varicella-zoster virus, sars-associated coronavirus, and measles virus. in a recent study of immunocompetent adult patients admitted to the hospital with cap, 18% had evidence of a viral etiology, and, in 9%, a respiratory virus was the only pathogen identified [176] . studies that include outpatients find viral pneumonia rates as high as 36% [167] . the frequency of other etiologic agents-for example, m. tuberculosis, chlamydophila psittaci (psittacosis), coxiella burnetii (q fever), francisella tularensis (tularemia), bordetella pertussis (whooping cough), and endemic fungi (histoplasma capsulatum, coccidioides immitis, cryptococcus neoformans, and blastomyces hominis)-is largely determined by the epidemiologic setting (table 8) but rarely exceeds 2%-3% total [113, 177] . the exception may be endemic fungi in the appropriate geographic distribution [100] . the need for specific anaerobic coverage for cap is generally overestimated. anaerobic bacteria cannot be detected by diagnostic techniques in current use. anaerobic coverage is clearly indicated only in the classic aspiration pleuropulmonary syndrome in patients with a history of loss of consciousness as a result of alcohol/drug overdose or after seizures in patients with concomitant gingival disease or esophogeal motility disorders. antibiotic trials have not demonstrated a need to specifically treat these organisms in the majority of cap cases. smallvolume aspiration at the time of intubation should be adequately handled by standard empirical severe cap treatment [178] and by the high oxygen tension provided by mechanical ventilation. resistance to commonly used antibiotics for cap presents another major consideration in choosing empirical therapy. resistance patterns clearly vary by geography. local antibiotic prescribing patterns are a likely explanation [179] [180] [181] . however, clonal spread of resistant strains is well documented. therefore, antibiotic recommendations must be modified on the basis of local susceptibility patterns. the most reliable source is state/provincial or municipal health department regional data, if available. local hospital antibiograms are generally the most accessible source of data but may suffer from small numbers of isolates. drug-resistant s. pneumoniae (drsp). the emergence of drug-resistant pneumococcal isolates is well documented. the incidence of resistance appears to have stabilized somewhat in the past few years. resistance to penicillin and cephalosporins may even be decreasing, whereas macrolide resistance continues to increase [179, 182] . however, the clinical relevance of drsp for pneumonia is uncertain, and few well-controlled studies have examined the impact of in vitro resistance on clinical outcomes of cap. published studies are limited by small sample sizes, biases inherent in observational design, and the relative infrequency of isolates exhibiting high-level resistance [183] [184] [185] . current levels of b-lactam resistance do not generally result in cap treatment failures when appropriate agents (i.e., amoxicillin, ceftriaxone, or cefotaxime) and doses are used, even in the presence of bacteremia [112, 186] . the available data suggest that the clinically relevant level of penicillin resistance is a mic of at least 4 mg/l [3] . one report suggested that, if cefuroxime is used to treat pneumococcal bacteremia when the organism is resistant in vitro, the outcome is worse than with other therapies [112] . other discordant therapies, including penicillin, did not have an impact on mortality. data exist suggesting that resistance to macrolides [187] [188] [189] and older fluoroquinolones (ciprofloxacin and levofloxacin) [180, 190, 191] results in clinical failure. to date, no failures have been reported for the newer fluoroquinolones (moxifloxacin and gemifloxacin). risk factors for infection with b-lactam-resistant s. pneumoniae include age !2 years or 165 years, b-lactam therapy within the previous 3 months, alcoholism, medical comorbidities, immunosuppressive illness or therapy, and exposure to a child in a day care center [112, [192] [193] [194] . although the relative predictive value of these risk factors is unclear, recent treatment with antimicrobials is likely the most significant. recent therapy or repeated courses of therapy with b-lactams, macrolides, or fluoroquinolones are risk factors for pneumococcal resistance to the same class of antibiotic [181, 193, 195, 196] . one study found that use of either a b-lactam or macrolide within the previous 6 months predicted an increased likelihood that, if pneumococcal bacteremia is present, the organism would be penicillin resistant [196] . other studies have shown that repeated use of fluoroquinolones predicts an increased risk of infection with fluoroquinolone-resistant pneumococci [195, 197] . whether this risk applies equally to all fluoroquinolones or is more of a concern for less active antipneumococcal agents (levofloxacin and ciprofloxacin) than for more active agents (moxifloxacin and gemifloxacin) is uncertain [190, 197, 198] . recommendations for the use of highly active agents in patients at risk for infection with drsp is, therefore, based only in part on efficacy considerations; it is also based on a desire to prevent more resistance from emerging by employing the most potent regimen possible. although increasing the doses of certain agents (penicillins, cephalosporins, levofloxacin) may lead to adequate outcomes in the majority of cases, switching to more potent agents may lead to stabilization or even an overall decrease in resistance rates [179, 180] . ca-mrsa. recently, an increasing incidence of pneumonia due to ca-mrsa has been observed [199, 200] . ca-mrsa appears in 2 patterns: the typical hospital-acquired strain [80] and, recently, strains that are epidemiologically, genotypically, and phenotypically distinct from hospital-acquired strains [201, 202] . many of the former may represent hcap, because these earlier studies did not differentiate this group from typical cap. the latter are resistant to fewer antimicrobials than are hospitalacquired mrsa strains and often contain a novel type iv sccmec gene. in addition, most contain the gene for panton-valentine leukocidin [200, 202] , a toxin associated with clinical features of necrotizing pneumonia, shock, and respiratory failure, as well as formation of abscesses and empyemas. the large majority of cases published to date have been skin infections in children. in a large study of ca-mrsa in 3 communities, 2% of ca-mrsa infections were pneumonia [203] . however, pneumonia in both adults [204] and children has been reported, often associated with preceding influenza. this strain should also be suspected in patients who present with cavitary infiltrates without risk factors for anaerobic aspiration pneu-monia (gingivitis and a risk for loss of consciousness, such as seizures or alcohol abuse, or esophogeal motility disorders). diagnosis is usually straightforward, with high yields from sputum and blood cultures in this characteristic clinical scenario. ca-mrsa cap remains rare in most communities but is expected to be an emerging problem in cap treatment. outpatient treatment. the following regimens are recommended for outpatient treatment on the basis of the listed clinical risks. the most common pathogens identified from recent studies of mild (ambulatory) cap were s. pneumoniae, m. pneumoniae, c. pneumoniae, and h. influenzae [177, 205] . mycoplasma infection was most common among patients !50 years of age without significant comorbid conditions or abnormal vital signs, whereas s. pneumoniae was the most common pathogen among older patients and among those with significant underlying disease. hemophilus infection was found in 5%mostly in patients with comorbidities. the importance of ther-apy for mycoplasma infection and chlamydophila infection in mild cap has been the subject of debate, because many infections are self-limiting [206, 207] . nevertheless, studies from the 1960s of children indicate that treatment of mild m. pneumoniae cap reduces the morbidity of pneumonia and shortens the duration of symptoms [208] . the evidence to support specific treatment of these microorganisms in adults is lacking. macrolides have long been commonly prescribed for treatment of outpatients with cap in the united states, because of their activity against s. pneumoniae and the atypical pathogens. this class includes the erythromycin-type agents (including dirithromycin), clarithromycin, and the azalide azithromycin. although the least expensive, erythromycin is not often used now, because of gastrointestinal intolerance and lack of activity against h. influenzae. because of h. influenzae, azithromycin is preferred for outpatients with comorbidities such as copd. numerous randomized clinical trials have documented the efficacy of clarithromycin and azithromycin as monotherapy for outpatient cap, although several studies have demonstrated that clinical failure can occur with a resistant isolate. when such patients were hospitalized and treated with a b-lactam and a macrolide, however, all survived and generally recovered without significant complications [188, 189] . most of these patients had risk factors for which therapy with a macrolide alone is not recommended in the present guidelines. thus, for patients with a significant risk of drsp infection, monotherapy with a macrolide is not recommended. doxycycline is included as a cost-effective alternative on the basis of in vitro data indicating effectiveness equivalent to that of erythromycin for pneumococcal isolates. the use of fluoroquinolones to treat ambulatory patients with cap without comorbid conditions, risk factors for drsp, or recent antimicrobial use is discouraged because of concern that widespread use may lead to the development of fluoroquinolone resistance [185] . however, the fraction of total fluoroquinolone use specifically for cap is extremely small and unlikely to lead to increased resistance by itself. more concerning is a recent study suggesting that many outpatients given a fluoroquinolone may not have even required an antibiotic, that the dose and duration of treatment were often incorrect, and that another agent often should have been used as firstline therapy. this usage pattern may promote the rapid development of resistance to fluoroquinolones [209] . comorbidities or recent antimicrobial therapy increase the likelihood of infection with drsp and enteric gram-negative bacteria. for such patients, recommended empirical therapeutic options include (1) a respiratory fluoroquinolone (moxifloxacin, gemifloxacin, or levofloxacin [750 mg daily]) or (2) combination therapy with a b-lactam effective against s. pneumoniae plus a macrolide (doxycycline as an alternative). on the basis of present pharmacodynamic principles, high-dose amox-icillin (amoxicillin [1 g 3 times daily] or amoxicillin-clavulanate [2 g 2 times daily]) should target 193% of s. pneumoniae and is the preferred b-lactam. ceftriaxone is an alternative to highdose amoxicillin when parenteral therapy is feasible. selected oral cephalosporins (cefpodoxime and cefuroxime) can be used as alternatives [210] , but these are less active in vitro than highdose amoxicillin or ceftriaxone. agents in the same class as the patient had been receiving previously should not be used to treat patients with recent antibiotic exposure. telithromycin is the first of the ketolide antibiotics, derived from the macrolide family, and is active against s. pneumoniae that is resistant to other antimicrobials commonly used for cap (including penicillin, macrolides, and fluoroquinolones). several cap trials suggest that telithromycin is equivalent to comparators (including amoxicillin, clarithromycin, and trovafloxacin) [211] [212] [213] [214] . there have also been recent postmarketing reports of life-threatening hepatotoxicity [215] . at present, the committee is awaiting further evaluation of the safety of this drug by the fda before making its final recommendation. inpatient, non-icu treatment. the following regimens are recommended for hospital ward treatment. level i evidence) 19. a b-lactam plus a macrolide (strong recommendation; level i evidence) (preferred b-lactam agents include cefotaxime, ceftriaxone, and ampicillin; ertapenem for selected patients; with doxycycline [level iii evidence] as an alternative to the macrolide. a respiratory fluoroquinolone should be used for penicillin-allergic patients.) the recommendations of combination treatment with a blactam plus a macrolide or monotherapy with a fluoroquinolone were based on retrospective studies demonstrating a significant reduction in mortality compared with that associated with administration of a cephalosporin alone [216] [217] [218] [219] . multiple prospective randomized trials have demonstrated that either regimen results in high cure rates. the major discriminating factor between the 2 regimens is the patient's prior antibiotic exposure (within the past 3 months). preferred b-lactams are those effective against s. pneumoniae and other common, nonatypical pathogens without being overly broad spectrum. in january 2002, the clinical laboratory standards institute (formerly the nccls) increased the mic breakpoints for cefotaxime and ceftriaxone for nonmeningeal s. pneumoniae infections. these new breakpoints acknowledge that nonmeningeal infections caused by strains formerly considered to be intermediately susceptible, or even resistant, can be treated successfully with usual doses of these b-lactams [112, 186, 220] . two randomized, double-blind studies showed ertapenem to be equivalent to ceftriaxone [221, 222] . it also has excellent activity against anaerobic organisms, drsp, and most enterobacteriaceae species (including extended-spectrum b-lactamase producers, but not p. aeruginosa). ertapenem may be useful in treating patients with risks for infection with these pathogens and for patients who have recently received antibiotic therapy. however, clinical experience with this agent is limited. other "antipneumococcal, antipseudomonal" b-lactam agents are appropriate when resistant pathogens, such as pseudomonas, are likely to be present. doxycycline can be used as an alternative to a macrolide on the basis of scant data for treatment of legionella infections [171, 223, 224] . two randomized, double-blind studies of adults hospitalized for cap have demonstrated that parenteral azithromycin alone was as effective, with improved tolerability, as intravenous cefuroxime, with or without intravenous erythromycin [225, 226] . in another study, mortality and readmission rates were similar, but the mean los was shorter among patients receiving azithromycin alone than among those receiving other guideline-recommended therapy [227] . none of the 10 patients with erythromycin-resistant s. pneumoniae infections died or was transferred to the icu, including 6 who received azithromycin alone. another study showed that those receiving a macrolide alone had the lowest 30-day mortality but were the least ill [219] . such patients were younger and were more likely to be in lower-risk groups. these studies suggest that therapy with azithromycin alone can be considered for carefully selected patients with cap with nonsevere disease (patients admitted primarily for reasons other than cap) and no risk factors for infection with drsp or gramnegative pathogens. however, the emergence of high rates of macrolide resistance in many areas of the country suggests that this therapy cannot be routinely recommended. initial therapy should be given intravenously for most admitted patients, but some without risk factors for severe pneumonia could receive oral therapy, especially with highly bioavailable agents such as fluoroquinolones. when an intravenous b-lactam is combined with coverage for atypical pathogens, oral therapy with a macrolide or doxycycline is appropriate for selected patients without severe pneumonia risk factors [228] . inpatient, icu treatment. the following regimen is the minimal recommended treatment for patients admitted to the icu. 20 . a b-lactam (cefotaxime, ceftriaxone, or ampicillin-sulbactam) plus either azithromycin (level ii evidence) or a fluoroquinolone (level i evidence) (strong recommendation) (for penicillin-allergic patients, a respiratory fluoroquinolone and aztreonam are recommended.) a single randomized controlled trial of treatment for severe cap is available. patients with shock were excluded; however, among the patients with mechanical ventilation, treatment with a fluoroquinolone alone resulted in a trend toward inferior outcome [229] . because septic shock and mechanical ventilation are the clearest reasons for icu admission, the majority of icu patients would still require combination therapy. icu patients are routinely excluded from other trials; therefore, recommendations are extrapolated from nonsevere cases, in conjunction with case series and retrospective analyses of cohorts with severe cap. for all patients admitted to the icu, coverage for s. pneumoniae and legionella species should be ensured [78, 230] by using a potent antipneumococcal b-lactam and either a macrolide or a fluoroquinolone. therapy with a respiratory fluoroquinolone alone is not established for severe cap [229] , and, if the patient has concomitant pneumococcal meningitis, the efficacy of fluoroquinolone monotherapy is uncertain. in addition, 2 prospective observational studies [231, 232] and 3 retrospective analyses [233] [234] [235] have found that combination therapy for bacteremic pneumococcal pneumonia is associated with lower mortality than monotherapy. the mechanism of this benefit is unclear but was principally found in the patients with the most severe illness and has not been demonstrated in nonbacteremic pneumococcal cap studies. therefore, combination empirical therapy is recommended for at least 48 h or until results of diagnostic tests are known. in critically ill patients with cap, a large number of microorganisms other than s. pneumoniae and legionella species must be considered. a review of 9 studies that included 890 patients with cap who were admitted to the icu demonstrates that the most common pathogens in the icu population were (in descending order of frequency) s. pneumoniae, legionella species, h. influenzae, enterobacteriaceae species, s. aureus, and pseudomonas species [171] . the atypical pathogens responsible for severe cap may vary over time but can account collectively for у20% of severe pneumonia episodes. the dominant atypical pathogen in severe cap is legionella [230] , but some diagnostic bias probably accounts for this finding [78] . the recommended standard empirical regimen should routinely cover the 3 most common pathogens that cause severe cap, all of the atypical pathogens, and most of the relevant enterobacteriaceae species. treatment of mrsa or p. aeruginosa infection is the main reason to modify the standard empirical regimen. the following are additions or modifications to the basic empirical regimen recommended above if these pathogens are suspected. pseudomonal cap requires combination treatment to prevent inappropriate initial therapy, just as pseudomonas nosocomial pneumonia does [131] . once susceptibilities are known, treatment can be adjusted accordingly. alternative regimens are provided for patients who may have recently received an oral fluoroquinolone, in whom the aminoglycoside-containing regimen would be preferred. a consistent gram stain of tracheal aspirate, sputum, or blood is the best indication for pseudomonas coverage. other, easier-to-treat gram-negative microorganisms may ultimately be proven to be the causative pathogen, but empirical coverage of pseudomonas species until culture results are known is least likely to be associated with inappropriate therapy. other clinical risk factors for infection with pseudomonas species include structural lung diseases, such as bronchiectasis, or repeated exacerbations of severe copd leading to frequent steroid and/or antibiotic use, as well as prior antibiotic therapy [131] . these patients do not necessarily require icu admission for cap [236] , so pseudomonas infection remains a concern for them even if they are only hospitalized on a general ward. the major risk factor for infection with other serious gram-negative pathogens, such as klebsiella pneumoniae or acinetobacter species, is chronic alcoholism. (moderate recommendation; level iii evidence.) the best indicator of s. aureus infection is the presence of gram-positive cocci in clusters in a tracheal aspirate or in an adequate sputum sample. the same findings on preliminary results of blood cultures are not as reliable, because of the significant risk of contamination [95] . clinical risk factors for s. aureus cap include end-stage renal disease, injection drug abuse, prior influenza, and prior antibiotic therapy (especially with fluoroquinolones [237] ). for methicillin-sensitive s. aureus, the empirical combination therapy recommended above, which includes a b-lactam and sometimes a respiratory fluoroquinolone, should be adequate until susceptibility results are available and specific therapy with a penicillinase-resistant semisynthetic penicillin or first-generation cephalosporin can be initiated. both also offer additional coverage for drsp. neither linezolid [241] nor vancomycin [238] is an optimal drug for methicillin-sensitive s. aureus. although methicillin-resistant strains of s. aureus are still the minority, the excess mortality associated with inappropriate an-tibiotic therapy [80] would suggest that empirical coverage should be considered when ca-mrsa is a concern. the most effective therapy has yet to be defined. the majority of ca-mrsa strains are more susceptible in vitro to non-b-lactam antimicrobials, including trimethoprim-sulfamethoxazole (tmp-smx) and fluoroquinolones, than are hospital-acquired strains. previous experience with tmp-smx in other types of severe infections (endocarditis and septic thrombophlebitis) suggests that tmp-smx is inferior to vancomycin [239] . further experience and study of the adequacy of tmp-smx for ca-mrsa cap is clearly needed. vancomycin has never been specifically studied for cap, and linezolid has been found to be better than ceftriaxone for bacteremic s. pneumoniae in a nonblinded study [240] and superior to vancomycin in retrospective analysis of studies involving nosocomial mrsa pneumonia [241] . newer agents for mrsa have recently become available, and others are anticipated. of the presently available agents, daptomycin should not be used for cap, and no data on pneumonia are available for tigecycline. a concern with ca-mrsa is necrotizing pneumonia associated with production of panton-valentine leukocidin and other toxins. vancomycin clearly does not decrease toxin production, and the effect of tmp-smx and fluoroquinolones on toxin production is unclear. addition of clindamycin or use of linezolid, both of which have been shown to affect toxin production in a laboratory setting [242] , may warrant their consideration for treatment of these necrotizing pneumonias [204] . unfortunately, the emergence of resistance during therapy with clindamycin has been reported (especially in erythromycinresistant strains), and vancomycin would still be needed for bacterial killing. clinicians should be aware of epidemiologic conditions and/ or risk factors that may suggest that alternative or specific additional antibiotics should be considered. these conditions and specific pathogens, with preferred treatment, are listed in tables 8 and 9. pathogen-directed therapy 23 . once the etiology of cap has been identified on the basis of reliable microbiological methods, antimicrobial therapy should be directed at that pathogen. (moderate recommendation; level iii evidence.) treatment options may be simplified (table 9) if the etiologic agent is established or strongly suspected. diagnostic procedures that identify a specific etiology within 24-72 h can still be useful for guiding continued therapy. this information is often available at the time of consideration for a switch from parenteral to oral therapy and may be used to direct specific oral antimicrobial choices. if, for example, an appropriate culture reveals penicillin-susceptible s. pneumoniae, a narrowspectrum agent (such as penicillin or amoxicillin) may be used. this will, hopefully, reduce the selective pressure for resistance. the major issue with pathogen-specific therapy is management of bacteremic s. pneumoniae cap. the implications of the observational finding that dual therapy was associated with reduced mortality in bacteremic pneumococcal pneumonia [231] [232] [233] [234] [235] are uncertain. one explanation for the reduced mortality may be the presence of undiagnosed coinfection with an atypical pathogen; although reported to occur in 18%-38% of cap cases in some studies [73, 175] , much lower rates of undiagnosed coinfection are found in general [171] and specifically in severe cases [78] . an alternative explanation is the immunomodulatory effects of macrolides [244, 245] . it is important to note that these studies evaluated the effects of initial empirical therapy before the results of blood cultures were known and did not examine effects of pathogen-specific therapy after the results of blood cultures were available. the benefit of combination therapy was also most pronounced in the more severely ill patients [233, 234] . therefore, discontinuation of combination therapy after results of cultures are known is most likely safe in non-icu patients. oseltamivir or zanamivir is recommended for influenza a. (strong recommendation; level i evidence.) 25. use of oseltamivir and zanamivir is not recommended for patients with uncomplicated influenza with symptoms for 148 h (level i evidence), but these drugs may be used to reduce viral shedding in hospitalized patients or for influenza pneumonia. (moderate recommendation; level iii evidence.) studies that demonstrate that treatment of influenza is effective only if instituted within 48 h of the onset of symptoms have been performed only in uncomplicated cases [246] [247] [248] [249] . the impact of such treatment on patients who are hospitalized with influenza pneumonia or a bacterial pneumonia complicating influenza is unclear. in hospitalized adults with influenza, a minority of whom had radiographically documented pneumonia, no obvious benefit was found in one retrospective study of amantadine treatment [250] . treatment of antigen-or culture-positive patients with influenza with antivirals in addition to antibiotics is warranted, even if the radiographic infiltrate is caused by a subsequent bacterial superinfection. because of the longer period of persistent positivity after infection, the appropriate treatment for patients diagnosed with only 1 of the rapid diagnostic tests is unclear. because such patients often have recoverable virus (median duration of 4 days) after hos-pitalization, antiviral treatment seems reasonable from an infection-control standpoint alone. because of its broad influenza spectrum, low risk of resistance emergence, and lack of bronchospasm risk, oseltamivir is an appropriate choice for hospitalized patients. the neuraminidase inhibitors are effective against both influenza a and b viruses, whereas the m2 inhibitors, amantadine, and rimantadine are active only against influenza a [251] . in addition, viruses recently circulating in the united states and canada are often resistant to the m2 inhibitors on the basis of antiviral testing [252, 253] . therefore, neither amantadine nor rimantadine should be used for treatment or chemoprophylaxis of influenza a in the united states until susceptibility to these antiviral medications has been reestablished among circulating influenza a viruses [249] . early treatment of influenza in ambulatory adults with inhaled zanamivir or oral oseltamivir appears to reduce the likelihood of lower respiratory tract complications [254] [255] [256] . the use of influenza antiviral medications appears to reduce the likelihood of respiratory tract complications, as reflected by reduced usage rates of antibacterial agents in ambulatory patients with influenza. although clearly important in outpatient pneumonia, this experience may also apply to patients hospitalized primarily for influenza. parenteral acyclovir is indicated for treatment of varicellazoster virus infection [257] recent human infections caused by avian influenza a (h5n1) in vietnam, thailand, cambodia, china, indonesia, egypt, and turkey raise the possibility of a pandemic in the near future. the severity of h5n1 infection in humans distinguishes it from that caused by routine seasonal influenza. respiratory failure requiring hospitalization and intensive care has been seen in the majority of the 1140 recognized cases, and mortality is ∼50% [258, 259] . if a pandemic occurs, deaths will result from primary influenza pneumonia with or without secondary bacterial pneumonia. this section highlights issues for consideration, recognizing that treatment recommendations will likely change as the pandemic progresses. more specific guidance can be found on the idsa, ats, cdc, and who web sites as the key features of the pandemic become clearer. additional guidance is available at http://www.pandemicflu.gov. the who has delineated 6 phases of an influenza pandemic, defined by increasing levels of risk and public health response [260] . during the current pandemic alert phase (phase 3: cases of novel influenza infection without sustained person-to-person transmission), testing should be focused on confirming all suspected cases in areas where h5n1 infection has been documented in poultry and on detecting the arrival of the pandemic strain in unaffected countries. early clinical features of h5n1 infection include persistent fever, cough, and respiratory difficulty progressing over 3-5 days, as well as lymphopenia on admission to the hospital [258, 259, 261] . exposure to sick and dying poultry in an area with known or suspected h5n1 activity has been reported by most patients, although the recognition of poultry outbreaks has sometimes followed the recognition of human cases [261] . rapid bedside tests to detect influenza a have been used as screening tools for avian influenza in some settings. throat swabs tested by rt-pcr have been the most sensitive for confirming h5n1 infection to date, but nasopharyngeal swabs, washes, and aspirates; bal fluid; lung and other tissues; and stool have yielded positive results by rt-pcr and viral culture with varying sensitivity. convalescent-phase serum can be tested by microneutralization for antibodies to h5 antigen in a small number of international reference laboratories. specimens from suspected cases of h5n1 infection should be sent to public health laboratories with appropriate biocontainment facilities; the case should be discussed with health department officials to arrange the transfer of specimens and to initiate an epidemiologic evaluation. during later phases of an ongoing pandemic, testing may be necessary for many more patients, so that appropriate treatment and infection control decisions can be made, and to assist in defining the extent of the pandemic. recommendations for such testing will evolve on the basis of the features of the pandemic, and guidance should be sought from the cdc and who web sites (http://www.cdc.gov and http://www.who.int). patients with confirmed or suspected h5n1 influenza should be treated with oseltamivir. most h5n1 isolates since 2004 have been susceptible to the neuraminidase inhibitors oseltamivir and zanamivir and resistant to the adamantanes (amantidine and rimantidine) [262, 263] . the current recommendation is for a 5-day course of treatment at the standard dosage of 75 mg 2 times daily. in addition, droplet precautions should be used for patients with suspected h5n1 influenza, and they should be placed in respiratory isolation until that etiology is ruled out. health care personnel should wear n-95 (or higher) respirators during medical procedures that have a high likelihood of generating infectious respiratory aerosols. bacterial superinfections, particularly pneumonia, are important complications of influenza pneumonia. the bacterial etiologies of cap after influenza infection have included s. pneumoniae, s. aureus, h. influenzae, and group a streptococci. legionella, chlamydophila, and mycoplasma species are not important causes of secondary bacterial pneumonia after influenza. appropriate agents would therefore include cefotaxime, ceftriaxone, and respiratory fluoroquinolones. treatment with vancomycin, linezolid, or other agents directed against ca-mrsa should be limited to patients with confirmed infection or a compatible clinical presentation (shock and necrotizing pneumonia). because shortages of antibacterials and antivirals are anticipated during a pandemic, the appropriate use of diagnostic tests will be even more important to help target antibacterial therapy whenever possible, especially for patients admitted to the hospital. time to first antibiotic dose for cap has recently received significant attention from a quality-of-care perspective. this emphasis is based on 2 retrospective studies of medicare beneficiaries that demonstrated statistically significantly lower mortality among patients who received early antibiotic therapy [109, 264] . the initial study suggested a breakpoint of 8 h [264] , whereas the subsequent analysis found that 4 h was associated with lower mortality [109] . studies that document the time to first antibiotic dose do not consistently demonstrate this difference, although none had as large a patient population. most importantly, prospective trials of care by protocol have not demonstrated a survival benefit to increasing the percentage of patients with cap who receive antibiotics within the first 4-8 h [22, 65] . early antibiotic administration does not appear to shorten the time to clinical stability, either [265] , although time of first dose does appear to correlate with los [266, 267] . a problem of internal consistency is also present, because, in both studies [109, 264] , patients who received antibiotics in the first 2 h after presentation actually did worse than those who retemperature р37.8؇c heart rate р100 beats/min respiratory rate р24 breaths/min systolic blood pressure у90 mm hg arterial oxygen saturation у90% or po 2 у60 mm hg on room air ability to maintain oral intake a normal mental status a note. criteria are from [268, 274, 294] . po 2 , oxygen partial pressure. a important for discharge or oral switch decision but not necessarily for determination of nonresponse. ceived antibiotics 2-4 h after presentation. for these and other reasons, the committee did not feel that a specific time window for delivery of the first antibiotic dose should be recommended. however, the committee does feel that therapy should be administered as soon as possible after the diagnosis is considered likely. conversely, a delay in antibiotic therapy has adverse consequences in many infections. for critically ill, hemodynamically unstable patients, early antibiotic therapy should be encouraged, although no prospective data support this recommendation. delay in beginning antibiotic treatment during the transition from the ed is not uncommon. especially with the frequent use of once-daily antibiotics for cap, timing and communication issues may result in patients not receiving antibiotics for 18 h after hospital admission. the committee felt that the best and most practical resolution to this issue was that the initial dose be given in the ed [22] . data from the medicare database indicated that antibiotic treatment before hospital admission was also associated with lower mortality [109] . given that there are even more concerns regarding timing of the first dose of antibiotic when the patient is directly admitted to a busy inpatient unit, provision of the first dose in the physician's office may be best if the recommended oral or intramuscular antibiotics are available in the office. with the use of a potent, highly bioavailable antibiotic, the ability to eat and drink is the major consideration for switching from intravenous to oral antibiotic therapy for non-icu patients. initially, ramirez et al. [268] defined a set of criteria for an early switch from intravenous to oral therapy (table 10). in general, as many as two-thirds of all patients have clinical improvement and meet criteria for a therapy switch in the first 3 days, and most non-icu patients meet these criteria by day 7. subsequent studies have suggested that even more liberal criteria are adequate for the switch to oral therapy. an alternative approach is to change from intravenous to oral therapy at a predetermined time, regardless of the clinical response [269] . one study population with nonsevere illness was randomized to receive either oral therapy alone or intravenous therapy, with the switch occurring after 72 h without fever. the study population with severe illness was randomized to receive either intravenous therapy with a switch to oral therapy after 2 days or a full 10-day course of intravenous antibiotics. time to resolution of symptoms for the patients with nonsevere illness was similar with either regimen. among patients with more severe illness, the rapid switch to oral therapy had the same rate of treatment failure and the same time to resolution of symptoms as prolonged intravenous therapy. the rapid-switch group required fewer inpatient days (6 vs. 11) , although this was likely partially a result of the protocol, but the patients also had fewer adverse events. the need to keep patients in the hospital once clinical stability is achieved has been questioned, even though physicians commonly choose to observe patients receiving oral therapy for у1 day. even in the presence of pneumococcal bacteremia, a switch to oral therapy can be safely done once clinical stability is achieved and prolonged intravenous therapy is not needed [270] . such patients generally take longer (approximately half a day) to become clinically stable than do nonbacteremic patients. the benefits of in-hospital observation after a switch to oral therapy are limited and add to the cost of care [32] . discharge should be considered when the patient is a candidate for oral therapy and when there is no need to treat any comorbid illness, no need for further diagnostic testing, and no unmet social needs [32, 271, 272] . although it is clear that clinically stable patients can be safely switched to oral therapy and discharged, the need to wait for all of the features of clinical stability to be present before a patient is discharged is uncertain. for example, not all investigators have found it necessary to have the white blood cell count improve. using the definition for clinical stability in table 10, halm et al. [273] found that 19.1% of 680 patients were discharged from the hospital with у1 instability. death or readmission occurred in 10.5% of patients with no instability on discharge, in 13.7% of patients with 1 instability, and in 46.2% with у2 instabilities. in general, patients in higher psi classes take longer to reach clinical stability than do patients in lower risk classes [274] . this finding may reflect the fact that elderly patients with multiple comorbidities often recover more slowly. arrangements for appropriate follow-up care, including rehabilitation, should therefore be initiated early for these patients. in general, when switching to oral antibiotics, either the same agent as the intravenous antibiotic or the same drug class should be used. switching to a different class of agents simply because of its high bioavailability (such as a fluoroquinolone) is probably not necessary for a responding patient. for patients who received intravenous b-lactam-macrolide combination therapy, a switch to a macrolide alone appears to be safe for those who do not have drsp or gram-negative enteric pathogens isolated [275] . most patients with cap have been treated for 7-10 days or longer, but few well-controlled studies have evaluated the optimal duration of therapy for patients with cap, managed in or out of the hospital. available data on short-course treatment do not suggest any difference in outcome with appropriate therapy in either inpatients or outpatients [276] . duration is also difficult to define in a uniform fashion, because some antibiotics (such as azithromycin) are administered for a short time yet have a long half-life at respiratory sites of infection. in trials of antibiotic therapy for cap, azithromycin has been used for 3-5 days as oral therapy for outpatients, with some reports of single-dose therapy for patients with atypical pathogen infections [276] [277] [278] . results with azithromycin should not be extrapolated to other drugs with significantly shorter half-lives. the ketolide telithromycin has been used for 5-7 days to treat outpatients, including some with pneumococcal bacteremia or psi classes уiii [211] . in a recent study, highdose (750 mg) levofloxacin therapy for 5 days was equally successful and resulted in more afebrile patients by day 3 than did the 500-mg dose for 7-10 days (49.1% vs. 38.5%; p p ) [276] . on the basis of these studies, 5 days appears to be .03 the minimal overall duration of therapy documented to be effective in usual forms of cap. as is discussed above, most patients become clinically stable within 3-7 days, so longer durations of therapy are rarely necessary. patients with persistent clinical instability are often readmitted to the hospital and may not be candidates for shortduration therapy. short-duration therapy may be suboptimal for patients with bacteremic s. aureus pneumonia (because of the risk of associated endocarditis and deep-seated infection), for those with meningitis or endocarditis complicating pneumonia, and for those infected with other, less common pathogens (e.g., burkholderia pseudomallei or endemic fungi). an 8-day course of therapy for nosocomial p. aeruginosa pneumonia led to relapse more commonly than did a 15-day course of therapy [279] . whether the same results would be applicable to cap cases is unclear, but the presence of cavities or other signs of tissue necrosis may warrant prolonged treatment. studies of duration of therapy have focused on patients receiving empirical treatment, and reliable data defining treatment duration after an initially ineffective regimen are lacking. drotrecogin alfa activated is the first immunomodulatory therapy approved for severe sepsis. in the united states, the fda recommended the use of drotrecogin alfa activated for patients at high risk of death. the high-risk criterion suggested by the fda was an acute physiologic and chronic health assessment (apache) ii score у25, based on a subgroup analysis of the overall study. however, the survival advantage (absolute risk reduction, 9.8%) of drotrecogin alfa activated treatment of patients in the cap subgroup was equivalent to that in the subgroup with apache ii scores у25 [92, 280, 281] . the greatest reduction in the mortality rate was for s. pneumoniae infection (relative risk, 0.56; 95% ci, 0.35-0.88) [282] . subsequent data have suggested that the benefit appears to be greatest when the treatment is given as early in the hospital admission as possible. in the subgroup with severe cap caused by a pathogen other than s. pneumoniae and treated with appropriate antibiotics, there was no evidence that drotrecogin alfa activated affected mortality. although the benefit of drotrecogin alfa activated is clearly greatest for patients with cap who have high apache ii scores, this criterion alone may not be adequate to select appropriate patients. an apache ii score у25 was selected by a subgroup analysis of the entire study cohort and may not be similarly calibrated in a cap-only cohort. two-organ failure, the criterion suggested for drotrecogin alfa activated use by the european regulatory agency, did not influence the mortality benefit for patients with cap [92] . therefore, in addition to patients with septic shock, other patients with severe cap could be considered for treatment with drotrecogin alfa activated. those with sepsis-induced leukopenia are at extremely high risk of death and ards and are, therefore, potential candidates. conversely, the benefit of drotrecogin alfa activated is not as clear when respiratory failure is caused more by exacerbation of underlying lung disease rather than by the pneumonia itself. other minor criteria for severe cap proposed above are similar to organ failure criteria used in many sepsis trials. consideration of treatment with drotrecogin alfa activated is appropriate, but the strength of the recommendation is only level ii. 35 . hypotensive, fluid-resuscitated patients with severe cap should be screened for occult adrenal insufficiency. (moderate recommendation; level ii evidence.) a large, multicenter trial has suggested that stress-dose (200-300 mg of hydrocortisone per day or equivalent) steroid treatment improves outcomes of vasopressor-dependent patients with septic shock who do not have an appropriate cortisol response to stimulation [283] . once again, patients with cap made up a significant fraction of patients entered into the trial. in addition, 3 small pilot studies have suggested that there is a benefit to corticosteroid therapy even for patients with severe cap who are not in shock [284] [285] [286] . the small sample size and baseline differences between groups compromise the conclusions. although the criteria for steroid replacement therapy remain controversial, the frequency of intermittent steroid treatment in patients at risk for severe cap, such as those with severe copd, suggests that screening of patients with severe cap is appropriate with replacement if inadequate cortisol levels are documented. if corticosteroids are used, close attention to tight glucose control is required [287] . 36 patients who do not require immediate intubation but who have either hypoxemia or respiratory distress should receive a trial of niv [114, 288, 289] . patients with underlying copd are most likely to benefit. patients with cap who were ran-domized to receive niv had a 125% absolute risk reduction for the need for intubation [114] . the use of niv may also improve intermediate-term mortality. inability to expectorate may limit the use of niv [290] , but intermittent application of niv may allow for its use in patients with productive cough unless sputum production is excessive. prompt recognition of a failed niv trial is critically important, because most studies demonstrate worse outcomes for patients who require intubation after a prolonged niv trial [288, 290] . within the first 1-2 h of niv, failure to improve respiratory rate and oxygenation [114, 289, 290] or failure to decrease carbon dioxide partial pressure (pco 2 ) in patients with initial hypercarbia [114] predicts niv failure and warrants prompt intubation. niv provides no benefit for patients with ards [289] , which may be nearly indistinguishable from cap among patients with bilateral alveolar infiltrates. patients with cap who have severe hypoxemia (pao 2 /fio 2 ratio, !150) are also poor candidates for niv [290] . 37. low-tidal-volume ventilation (6 cm 3 /kg of ideal body weight) should be used for patients undergoing ventilation who have diffuse bilateral pneumonia or ards. (strong recommendation; level i evidence.) distinguishing between diffuse bilateral pneumonia and ards is difficult, but it may not be an important distinction. results of the ardsnet trial suggest that the use of low-tidalvolume ventilation provides a survival advantage [291] . pneumonia, principally cap, was the most common cause of ards in that trial, and the benefit of the low-tidal-volume ventilatory strategy appeared to be equivalent in the population with pneumonia compared with the entire cohort. the absolute risk reduction for mortality in the pneumonia cohort was 11%, indicating that, in order to avoid 1 death, 9 patients must be treated [292] . other aspects of the management of severe sepsis and septic shock in patients with cap do not appear to be significantly different from those for patients with other sources of infection. recommendations for these aspects of care are reviewed elsewhere [293] . because of the limitations of diagnostic testing, the majority of cap is still treated empirically. critical to empirical therapy is an understanding of the management of patients who do not follow the normal response pattern. although difficult to define, nonresponse is not uncommon. overall, 6%-15% of hospitalized patients with cap do not respond to the initial antibiotic treatment [81, 84, 101, 294] . the incidence of treatment failure among patients with cap who are not hospitalized is not well known, because population-based studies are required. almirall et al. [295] described an overall hospitalization rate of 60% in a population-based study, but the rate of failure among the 30% of patients who initially presented to their primary care physician was not provided. the frequency of prior antibiotic therapy among medicare patients admitted to the hospital with cap is 24%-40% [95, 109] , but the percentage who received prior antibiotic therapy for the acute episode of pneumonia itself versus other indications is unclear. for patients initially admitted to the icu, the risk of failure to respond is already high; as many as 40% will experience deterioration even after initial stabilization in the icu [101] . mortality among nonresponding patients is increased several-fold in comparison with that among responding patients [296] . overall mortality rates as high as 49% have been reported for an entire population of nonresponding hospitalized patients with cap [76, 84, 101] , and the mortality rate reported in one study of early failure was 27% [81] . apache ii score was not the only factor independently associated with mortality in the nonresponding group, suggesting that the excess mortality may be due to factors other than severity of illness at presentation [101] . 38. the use of a systematic classification of possible causes of failure to respond, based on time of onset and type of failure (table 11) , is recommended. (moderate recommendation; level ii evidence.) the term "nonresponding pneumonia" is used to define a situation in which an inadequate clinical response is present despite antibiotic treatment. lack of a clear-cut and validated definition in the literature makes nonresponse difficult to study. lack of response also varies according to the site of treatment. lack of response in outpatients is very different from that in patients admitted to the icu. the time of evaluation is also important. persistent fever after the first day of treatment differs significantly from fever persisting (or recurring) at day 7 of treatment. table 11 provides a construct for evaluating nonresponse to antibiotic treatment of cap, based on several studies addressing this issue [76, 81, 84, 101] . two patterns of unacceptable response are seen in hospitalized patients [101] . the first is progressive pneumonia or actual clinical deterioration, with acute respiratory failure requiring ventilatory support and/or septic shock, usually occurring within the first 72 h of hospital admission. as is noted above, as many as 45% of patients with cap who ultimately require icu admission are initially admitted to a non-icu setting and are transferred because of deterioration [75] . deterioration and development of respira-tory failure or hypotension 172 h after initial treatment is often related to intercurrent complications, deterioration in underlying disease, or development of nosocomial superinfection. the second pattern is that of persistent or nonresponding pneumonia. nonresponse can be defined as absence of or delay in achieving clinical stability, using the criteria in table 10 [274, 294] . when these criteria were used, the median time to achieve clinical stability was 3 days for all patients, but a quarter of patients took у6 days to meet all of these criteria for stability [274] . stricter definitions for each of the criteria and higher psi scores were associated with longer times to achieve clinical stability. conversely, subsequent transfer to the icu after achieving this degree of clinical stability occurred in !1% of [297] . given these results, concern regarding nonresponse should be tempered before 72 h of therapy. antibiotic changes during this period should be considered only for patients with deterioration or in whom new culture data or epidemiologic clues suggest alternative etiologies. finally, nonresolving or slow-resolving pneumonia has been used to refer to the conditions of patients who present with persistence of pulmonary infiltrates 130 days after initial pneumonia-like syndrome [298] . as many as 20% of these patients will be found to have diseases other than cap when carefully evaluated [295] . two studies have evaluated the risk factors for a lack of response in multivariate analyses [81, 84] , including those amenable to medical intervention. use of fluoroquinolones was independently associated with a better response in one study [84] , whereas discordant antimicrobial therapy was associated with early failure [81] . in table 12, the different risk and protective factors and their respective odds ratios are summarized. specific causes that may be responsible for a lack of response in cap have been classified by arancibia et al. [101] (table 11) . this classification may be useful for clinicians as a systematic approach to diagnose the potential causes of nonresponse in cap. although in the original study only 8 (16%) of 49 cases could not be classified [101] , a subsequent prospective multicenter trial found that the cause of failure could not be determined in 44% [84] . management of nonresponding cap. nonresponse to antibiotics in cap will generally result in у1 of 3 clinical responses: (1) transfer of the patient to a higher level of care, (2) further diagnostic testing, and (3) escalation or change in treatment. issues regarding hospital admission and icu transfer are discussed above. an inadequate host response, rather than inappropriate antibiotic therapy or unexpected microorganisms, is the most common cause of apparent antibiotic failure when guidelinerecommended therapy is used. decisions regarding further diagnostic testing and antibiotic change/escalation are intimately intertwined and need to be discussed in tandem. information regarding the utility of extensive microbiological testing in cases of nonresponding cap is mainly retrospective and therefore affected by selection bias. a systematic diagnostic approach, which included invasive, noninvasive, and imaging procedures, in a series of nonresponding patients with cap obtained a specific diagnosis in 73% [101] . in a different study, mortality among patients with microbiologically guided versus empirical antibiotic changes was not improved (mortality rate, 67% vs. 64%, respectively) [76] . however, no antibiotic changes were based solely on sputum smears, suggesting that invasive cultures or nonculture methods may be needed. mismatch between the susceptibility of a common causative organism, infection with a pathogen not covered by the usual empirical regimen, and nosocomial superinfection pneumonia are major causes of apparent antibiotic failure. therefore, the first response to nonresponse or deterioration is to reevaluate the initial microbiological results. culture or sensitivity data not available at admission may now make the cause of clinical failure obvious. in addition, a further history of any risk factors for infection with unusual microorganisms (table 8) should be taken if not done previously. viruses are relatively neglected as a cause of infection in adults but may account for 10%-20% of cases [299] . other family members or coworkers may have developed viral symptoms in the interval since the patient was admitted, increasing suspicion of this cause. the evaluation of nonresponse is severely hampered if a microbiological diagnosis was not made on initial presentation. if cultures were not obtained, clinical decisions are much more difficult than if the adequate cultures were obtained but negative. risk factors for nonresponse or deterioration (table 12) , therefore, figure prominently in the list of situations in which more aggressive initial diagnostic testing is warranted (table 5) . blood cultures should be repeated for deterioration or progressive pneumonia. deteriorating patients have many of the risk factors for bacteremia, and blood cultures are still high yield even in the face of prior antibiotic therapy [95] . positive blood culture results in the face of what should be adequate antibiotic therapy should increase the suspicion of either antibiotic-resistant isolates or metastatic sites, such as endocarditis or arthritis. despite the high frequency of infectious pulmonary causes of nonresponse, the diagnostic utility of respiratory tract cultures is less clear. caution in the interpretation of sputum or tracheal aspirate cultures, especially of gram-negative bacilli, is warranted because early colonization, rather than superinfection with resistant bacteria, is not uncommon in specimens obtained after initiation of antibiotic treatment. once again, the absence of multidrug-resistant pathogens, such as mrsa or pseudomonas, is strong evidence that they are not the cause of nonresponse. an etiology was determined by bronchoscopy in 44% of patients with cap, mainly in those not responding to therapy [300] . despite the potential benefit suggested by these results, and in contrast to ventilator-associated pneumonia [301, 302] , no randomized study has compared the utility of invasive versus noninvasive strategies in the cap population with nonresponse. rapid urinary antigen tests for s. pneumoniae and l. pneumophila remain positive for days after initiation of antibiotic therapy [147, 152] and, therefore, may be high-yield tests in this group. a urinary antigen test result that is positive for l. pneumophila has several clinical implications, including that coverage for legionella should be added if not started empirically [81] . this finding may be a partial explanation for the finding that fluoroquinolones are associated with a lower incidence of nonresponse [84] . if a patient has persistent fever, the faster response to fluoroquinolones in legionella cap warrants consideration of switching coverage from a macrolide [303] . stopping the b-lactam component of combination therapy to exclude drug fever is probably also safe [156] . because one of the major explanations for nonresponse is poor host immunity rather than incorrect antibiotics, a positive pneumococcal antigen test result would at least clarify the probable original pathogen and turn attention to other causes of failure. in addition, a positive pneumococcal antigen test result would also help with interpretation of subsequent sputum/tracheal aspirate cultures, which may indicate early superinfection. nonresponse may also be mimicked by concomitant or subsequent extrapulmonary infection, such as intravascular catheter, urinary, abdominal, and skin infections, particularly in icu patients. appropriate cultures of these sites should be considered for patients with nonresponse to cap therapy. in addition to microbiological diagnostic procedures, several other tests appear to be valuable for selected patients with nonresponse: • chest ct. in addition to ruling out pulmonary emboli, a ct scan can disclose other reasons for antibiotic failure, including pleural effusions, lung abscess, or central airway obstruction. the pattern of opacities may also suggest alternative noninfectious disease, such as bronchiolitis obliterans organizing pneumonia. • thoracentesis. empyema and parapneumonic effusions are important causes of nonresponse [81, 101] , and thoracentesis should be performed whenever significant pleural fluid is present. • bronchoscopy with bal and transbronchial biopsies. if the differential of nonresponse includes noninfectious pneumonia mimics, bronchoscopy will provide more diagnostic information than routine microbiological cultures. bal may reveal noninfectious entities, such as pulmonary hemorrhage or acute eosinophilic pneumonia, or hints of infectious diseases, such as lymphocytic rather than neutrophilic alveolitis pointing toward virus or chlamydophila infection. transbronchial biopsies can also yield a specific diagnosis. antibiotic management of nonresponse in cap has not been studied. the overwhelming majority of cases of apparent nonresponse are due to the severity of illness at presentation or a delay in treatment response related to host factors. other than the use of combination therapy for severe bacteremic pneumococcal pneumonia [112, 231, 233, 234] , there is no documentation that additional antibiotics for early deterioration lead to a better outcome. the presence of risk factors for potentially untreated microorganisms may warrant temporary empirical broadening of the antibiotic regimen until results of diagnostic tests are available. vaccines targeting pneumococcal disease and influenza remain the mainstay for preventing cap. pneumococcal polysaccharide vaccine and inactivated influenza vaccine are recommended for all older adults and for younger persons with medical conditions that place them at high risk for pneumonia morbidity and mortality (table 13) [304, 305] . the new live attenuated influenza vaccine is recommended for healthy persons 5-49 years of age, including health care workers [304] . postlicensure epidemiologic studies have documented the effectiveness of pneumococcal polysaccharide vaccines for prevention of invasive infection (bacteremia and meningitis) among elderly individuals and younger adults with certain chronic medical conditions [306] [307] [308] [309] . the overall effectiveness against invasive pneumococcal disease among persons у65 years of age is 44%-75% [306, 308, 310] , although efficacy may decrease with advancing age [308] . the effectiveness of the vaccine against pneumococcal disease in immunocompromised persons is less clear, and results of studies evaluating its effectiveness against pneumonia without bacteremia have been mixed. the vaccine has been shown to be cost effective for general populations of adults 50-64 years of age and у65 years of age [311, 312] . a second dose of pneumococcal polysaccharide vaccine after a у5-year interval has been shown to be safe, with only slightly more local reactions than are seen after the first dose [313] . because the safety of a third dose has not been demonstrated, current guidelines do not suggest repeated revaccination. the pneumococcal conjugate vaccine is under investigation for use in adults but is currently only licensed for use in young children [314, 315] . however, its use in children !5 years of age has dramatically reduced invasive pneumococcal bacteremia among adults as well [314, 316] . the effectiveness of influenza vaccines depends on host factors and on how closely the antigens in the vaccine are matched with the circulating strain of influenza. a systematic review demonstrates that influenza vaccine effectively prevents pneumonia, hospitalization, and death [317, 318] . a recent large observational study of adults у65 years of age found that vaccination against influenza was associated with a reduction in the risk of hospitalization for cardiac disease (19% reduction), cerebrovascular disease (16%-23% reduction), and pneumonia or influenza (29%-32% reduction) and a reduction in the risk of death from all causes (48%-50% reduction) [319] . in longterm-care facilities, vaccination of health care workers with influenza vaccine is an important preventive health measure [318, 320, 321] . because the main virulence factors of influenza virus, a neuraminidase and hemagglutinin, adapt quickly to selective pressures, new vaccine formulations are created each year on the basis of the strains expected to be circulating, and annual revaccination is needed for optimal protection. 43 many people who should receive either influenza or pneumococcal polysaccharide vaccine have not received them. according to a 2003 survey, only 69% of adults у65 years of age had received influenza vaccine in the past year, and only 64% had ever received pneumococcal polysaccharide vaccine [322] . coverage levels are lower for younger persons with vaccine indications. among adults 18-64 years of age with diabetes, 49% had received influenza vaccine, and 37% had ever received pneumococcal vaccine [323] . studies of vaccine delivery methods indicate that the use of standing orders is the best way to improve vaccination coverage in office, hospital, or long-term care settings [324] . hospitalization of at-risk patients represents an underutilized opportunity to assess vaccination status and to either provide or recommend immunization. ideally, patients should be vaccinated before developing pneumonia; therefore, admissions for illnesses other than respiratory tract infections would be an appropriate focus. however, admission for pneumonia is an important trigger for assessing the need for immunization. the actual immunization may be better provided at the time of outpatient follow-up, especially with the emphasis on early discharge of patients with cap. patients with an acute fever should not be vaccinated until their fever has resolved. confusion of a febrile reaction to immunization with recurrent/superinfection pneumonia is a risk. however, immunization at discharge for pneumonia is warranted for patients for whom outpatient follow-up is unreliable, and such vaccinations have been safely given to many patients. the best time for influenza vaccination in north america is october and november, although vaccination in december and later is recommended for those who were not vaccinated earlier. influenza and pneumococcal vaccines can be given at the same time in different arms. chemoprophylaxis can be used as an adjunct to vaccination for prevention and control of influenza. oseltamivir and zanamivir are both approved for prophylaxis; amantadine and rimantadine have fda indications for chemoprophylaxis against influenza a infection, but these agents are currently not recommended because of the frequency of resistance among strains circulating in the united states and canada [252, 253] . developing an adequate immune response to the inactivated influenza vaccine takes ∼2 weeks in adults; chemoprophylaxis may be useful during this period for those with household exposure to influenza, those who live or work in institutions with an influenza outbreak, or those who are at high risk for influenza complications in the setting of a community outbreak [325, 326] . chemoprophylaxis also may be useful for persons with contraindications to influenza vaccine or as an adjunct to vaccination for those who may not respond well to influenza vaccine (e.g., persons with hiv infection) [325, 326] . the use of influenza antiviral medications for treatment or chemoprophylaxis should not affect the response to the inactivated vaccine. because it is unknown whether administering influenza antiviral medications affects the performance of the new live attenuated intranasal vaccine, this vaccine should not be used in conjunction with antiviral agents. other types of vaccination can be considered. pertussis is a rare cause of pneumonia itself. however, pneumonia is one of the major complications of pertussis. concern over waning immunity has led the acip to emphasize adult immunization for pertussis [327] . one-time vaccination with the new tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine-adsorbed (tdap) product, adacel (sanofi pasteur)is recommended for adults 19-64 years of age. for most adults, the vaccine should be given in place of their next routine tetanus-diphtheria booster; adults with close contact with infants !12 months of age and health care workers should receive the vaccine as soon as possible, with an interval as short as 2 years after their most recent tetanus/diphtheria booster. 46 smoking is associated with a substantial risk of pneumococcal bacteremia; one report showed that smoking was the strongest of multiple risks for invasive pneumococcal disease in immunocompetent nonelderly adults [328] . smoking has also been identified as a risk for legionella infection [329] . smoking cessation should be attempted when smokers are hospitalized; this is particularly important and relevant when these patients are hospitalized for pneumonia. materials for clinicians and patients to assist with smoking cessation are available online from the us surgeon general (http://www.surgeongeneral.gov/tobacco), the centers for disease control and prevention (http://www.cdc.gov/ tobacco), and the american cancer society (http://www .cancer.org). the most successful approaches to quitting include some combination of nicotine replacement and/or bupropion, a method to change habits, and emotional support. given the increased risk of pneumonia, the committee felt that persons unwilling to stop smoking should be given the pneumococcal polysaccharide vaccine, although this is not currently an aciprecommended indication. 48 . cases of pneumonia that are of public health concern should be reported immediately to the state or local health department. (strong recommendation; level iii evidence.) public health interventions are important for preventing some forms of pneumonia. notifying the state or local health department about a condition of interest is the first step to getting public health professionals involved. rules and regulations regarding which diseases are reportable differ between states. for pneumonia, most states require reporting for legionnaires disease, sars, and psittacosis, so that an investigation can determine whether others may be at risk and whether control measures are necessary. for legionnaires disease, reporting of cases has helped to identify common-source outbreaks caused by environmental contamination [130] . for sars, close observation and, in some cases, quarantine of close contacts have been critical for controlling transmission [330] . in addition, any time avian influenza (h5n1) or a possible terrorism agent (e.g., plague, tularemia, or anthrax) is being considered as the etiology of pneumonia, the case should be reported immediately, even before a definitive diagnosis is obtained. in addition, pneumonia cases that are caused by pathogens not thought to be endemic to the area should be reported, even if those conditions are not typically on the list of reportable conditions, because control strategies might be possible. for other respiratory diseases, episodes that are suspected of being part of an outbreak or cluster should be reported. for pneumococcal disease and influenza, outbreaks can occur in crowded settings of susceptible hosts, such as homeless shelters, nursing homes, and jails. in these settings, prophylaxis, vaccination, and infection control methods are used to control further transmission [331] . for mycoplasma, antibiotic prophylaxis has been used in schools and institutions to control outbreaks [332] . 49 . respiratory hygiene measures, including the use of hand hygiene and masks or tissues for patients with cough, should be used in outpatient settings and eds as a means to reduce the spread of respiratory infections. (strong recommendation; level iii evidence.) in part because of the emergence of sars, improved respiratory hygiene measures ("respiratory hygiene" or "cough etiquette") have been promoted as a means for reducing transmission of respiratory infections in outpatient clinics and eds [333] . key components of respiratory hygiene include encouraging patients to alert providers when they present for a visit and have symptoms of a respiratory infection; the use of hand hygiene measures, such as alcohol-based hand gels; and the use of masks or tissues to cover the mouth for patients with respiratory illnesses. in a survey of the us population, the use of masks in outpatient settings was viewed as an acceptable means for reducing the spread of respiratory infections [334] . for hospitalized patients, infection control recommendations typically are pathogen specific. for more details on the use of personal protective equipment and other measures to prevent transmission within health care settings, refer to the healthcare infection control practices advisory committee [335] . performance indicators are tools to help guideline users measure both the extent and the effects of implementation of guidelines. such tools or measures can be indicators of the process itself, outcomes, or both. deviations from the recommendations are expected in a proportion of cases, and compliance in 80%-95% of cases is generally appropriate, depending on the indicator. four specific performance indicators have been selected for the cap guidelines, 3 of which focus on treatment issues and 1 of which deals with prevention: • initial empirical treatment of cap should be consistent with guideline recommendations. data exist that support the role of cap guidelines and that have demonstrated reductions in cost, los, and mortality when the guidelines are followed. reasons for deviation from the guidelines should be clearly documented in the medical record. • the first treatment dose for patients who are to be admitted to the hospital should be given in the ed. unlike in prior guidelines, a specific time frame is not being recommended. initiation of treatment would be expected within 6-8 h of presentation whenever the admission diagnosis is likely cap. a rush to treatment without a diagnosis of cap can, however, result in the inappropriate use of antibiotics with a concomitant increase in costs, adverse drug events, increased antibiotic selection pressure, and, possibly, increased antibiotic resistance. consideration should be given to monitoring the number of patients who receive empirical antibiotics in the ed but are admitted to the hospital without an infectious diagnosis. • mortality data for all patients with cap admitted to wards, icus, or high-level monitoring units should be collected. although tools to predict mortality and severity of illness exist-such as the psi and curb-65 criteria, respectivelynone is foolproof. overall mortality rates for all patients with cap admitted to the hospital, including general medical wards, should be monitored and compared with severity-adjusted norms. in addition, careful attention should be paid to the percentage of patients with severe cap, as defined in this document, who are admitted initially to a non-icu or a high-level monitoring unit and to their mortality rate. • it is important to determine what percentage of at-risk patients in one's practice actually receive immunization for influenza or pneumococcal infection. prevention of infection is clearly more desirable than having to treat established infection, but it is clear that target groups are undervaccin-ated. trying to increase the number of protected individuals is a desirable end point and, therefore, a goal worth pursuing. this is particularly true for influenza, because the vaccine data are more compelling, but it is important to try to protect against pneumococcal infection as well. coverage of 90% of adults у65 years of age should be the target. 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prospective, randomized comparison of oseltamivir treatment with or without postexposure prophylaxis efficacy of an acellular pertussis vaccine among adolescents and adults cigarette smoking and invasive pneumococcal disease. active bacterial core surveillance team surveillance for legionnaires' disease: risk factors for morbidity and mortality sars in healthcare facilities an outbreak of multidrugresistant pneumococcal pneumonia and bacteremia among unvaccinated nursing home residents azithromycin prophylaxis during a hospital outbreak of mycoplasma pneumoniae pneumonia respiratory hygiene/cough etiquette in health-care settings experiences with influenza-like illness and attitudes regarding influenza prevention-united states, 2003-04 influenza season guideline for isolation precautions in hospitals. the hospital infection control practices advisory committee the committee wishes to express its gratitude to robert balk, christian brun-buisson, ali el-sohl, alan fein, donald e. low, constantine manthous, thomas j. marrie, joseph f. plouffe, and david a. talan, for their thoughtful review of an earlier version of the guidelines. supplement sponsorship. this article was published as part of a supplement entitled "infectious diseases society of america/american thoracic society consensus guidelines on the management of community-acquired pneumonia in adults," sponsored by the infectious diseases society of america. key: cord-303165-ikepr2p2 authors: tulchinsky, theodore h.; varavikova, elena a. title: expanding the concept of public health date: 2014-10-10 journal: the new public health doi: 10.1016/b978-0-12-415766-8.00002-1 sha: doc_id: 303165 cord_uid: ikepr2p2 ancient societies recognized the needs of sanitation, food safety, workers’ health, and medical care to protect against disease and to promote well-being and civic prosperity. new energies and knowledge since the eighteenth century produced landmark discoveries such as prevention of scurvy and vaccination against smallpox. the biological germ theory and competing miasma theory each proved effective in sanitation, and immunization in control of infectious diseases. non-communicable diseases as the leading causes of mortality have responded to innovative preventive care of health risk factors, smoking, hypertension, obesity, physical inactivity, unhealthful diets, and diabetes mellitus. health promotion proved effective to modern public health in tackling disease origins, individual behavior, and social and economic conditions. the global burden of infectious and non-communicable diseases, aging and chronic illness faces rising costs and still inadequate prevention. the evolution of concepts of public health will have to address these new challenges of population health. the development of public health from its ancient and recent roots, especially in the past several centuries, is a continuing process, with evolutionary and sometimes dramatic leaps forward, and important continuing and new challenges for personal and population health and well-being. everything in the new public health is about preventing avoidable disease, injuries, disabilities, and death while promoting and maximizing a healthy environment and optimal conditions for current and future generations. thus, the new public health addresses overall health policy, resource allocation, as well as the organization, management, and provision of medical care and of health systems in general within a framework of overall social policy and in a community, state, national, transnational, and global context. the study of history (see chapter 1) helps us to understand the process of change, to define where we came from and where we are going. it is vital to recognize and understand change in order to deal with radical transformations in direction that occur as a result of changing demography and epidemiology, new science, evolving best practices in public health and clinical medicine, and above all inequalities in health resulting from societal system failures and social and economic factors. health needs will continue to develop in the context of environmental, demographic and societal adjustments, with knowledge gained from social and physical sciences, practice, and economics. for the coming generations, this is about not only the quality of life, but the survival of society itself. over the past century there have been many definitions of public health and health for all. mostly they represent visions and ideals of societal and global aspirations. this chapter examines the very base of the new public health, which encompasses the classic issues of public health with recognition of the advances made in health promotion and the management of health care systems as integral components of societal efforts to improve the health of populations and of individuals. what follows in succeeding chapters will address the major concepts leading to modern and comprehensive elements of public health. inevitably, concepts of public health continue to evolve and to develop both as a philosophy and as a structured discipline. as a professional field, public health requires specialists trained with knowledge and appreciation of its evolution, scientific advances, concepts, and best practices, old and modern. it demands sophisticated professional and managerial skills, the ability to address a problem, reasoning to define the issues, and to advocate, initiate, develop, and implement new and revised programs. it calls for profoundly humanistic values and a sense of responsibility towards protecting and improving the health of communities and every individual. in the twenty-first century, this set of values was well expressed in the human development index agreed to by 160 nations (box 2.1). public health is a multidimensional field and therefore multidisciplinary in its workforce and organizational needs. it is based on scientific advances and application of best practices as they evolve, and includes many concepts, including holistic health, first established in ancient times. the discussion will return to the diversity of public health throughout this chapter and book many times. in previous centuries, public health was seen primarily as a discipline which studies and implements measures for control of communicable diseases, primarily by sanitation and vaccination. the sanitary revolution, which preceded the development of modern bacteriology, made an enormous contribution to improved health, but many other societal factors including improved nutrition, education, and housing were no less important for population health. maternal and child health, occupational health, and many other aspects of a growing public health network of activities played important roles, as have the physical and social environment and personal habits of living in determining health status. in recent decades recognition of the importance of women's health and health inequalities associated with many high-risk groups in the population have seen both successes and failures in addressing their challenges. male health issues have received less attention, apart from issues associated with specific diseases, or those of healthy military personnel. the scope of public health has changed along with growth of the medical, social, and public health sciences, public expectations, and practical experience. taken together, these have all contributed to changes in the concepts and causes of disease. health systems that fail to adjust to changes in fundamental concepts of public health suffer from immense inequity and burdens of preventable disease, disability, and death. this chapter examines expanding concepts of public health, leading to the development of a new public health. public health has evolved as a multidisciplinary field that includes the use of basic and applied science, education, social sciences, economics, management, and communication skills to promote the welfare of the individual and the community. it is greater than the sum of its component elements and includes the art and politics of the funding and coordination of the wide diversity of community and individual health services. the concept of the interdependence of health in body and in mind has ancient origins. they continue to be fundamental to individuals and societies, and part of the fundamental rights of all humans to have knowledge of healthful lifestyles and to have access to those measures of good health that society alone is able to provide, such as immunization programs, food and drug safety and quality standards, environmental and occupational health, and universal access to high-quality primary and specialty medical and other vital health services. this holistic view of balance and equilibrium may be a renaissance of classical greek and biblical traditions, applied with the broad new knowledge and experience of public health and medical care of the nineteenth, twentieth, and the early years of the twenty-first centuries as change continues to challenge our capacity to adapt. the competing nineteenth-century germ and miasma theories of biological and environmental causation of illness each contributed to the development of sanitation, hygiene, immunization, and understanding of the biological and social determinants of disease and health. they come together in the twenty-first century encompassed in a holistic new public health addressing individual and population health needs. medicine and public health professionals both engage in organization and in direct care services. these all necessitate an understanding of the issues that are included in the new public health, how they evolved, interact, are put together in organizations, and are financed and operated in various parts of the world in order to understand changes going on before our eyes. great success has been achieved in reducing the burden of disease with tools and concepts currently at our disposal. the idea that this is an entitlement for everyone was articulated in the health for all concept of alma-ata in 1978. the health promotion movement emerged in the 1970s and showed dramatically effective results in managing the new human immunodeficiency virus (hiv) pandemic and in tackling smoking and other risk factors for non-communicable diseases (ncds). a health in all policy concept emerged in 2006 promoting the concept that health should be a basic component of all public and private policies to achieve the full potential of public health and eliminate inequalities associated with social and economic conditions. profound changes are taking place in the world population, and public health is crucial to respond accordingly: mass migration to the cities, fewer children, extended life expectancy, and the increase in the population of older people who are subject to more chronic diseases and disabilities in a changing physical, social, and economic climate. health systems are challenged with continuing development of new medical technologies and related reforms in clinical practice, while experiencing strong influences of pharmaceuticals and the medicalization of health, with prevention and health promotion less central in priorities and resource allocation. globalization of health has many meanings: international trade, improving global communications, and economic changes with increasing flows of goods, services, and people. ecological and climate change bring droughts, hurricanes, arctic meltdown, and rising sea levels. globalization also has political effects, with water and food shortages, terrorism, and economic distress affecting billions of people. in terms of health, disease can spread from one part of the world to others, as in pandemics or in a quiet spread such as that of west nile fever moving from its original middle eastern natural habitat to the americas and europe, or severe acute respiratory syndrome (sars), which spread with lightning speed from chinese villages to metropolitan cities such as toronto, canada. it can also mean that the ncds characteristic of the industrialized countries are now recognized as the leading causes of death in low-and middle-income countries, associated with diet, activity levels, and smoking, which are themselves pandemic risk factors. the potential for global action in health can also be dramatic. the eradication of smallpox was a stunning victory for public health. the campaign to eradicate poliomyelitis is succeeding even though the end-stage is fraught with setbacks, and measles elimination has turned out to be more of a challenge than was anticipated a decade ago, with resurgence in countries thought to have it under control. global health policies have also made the achievements of public-private partnerships of great importance, particularly in vaccination and acquired immunodeficiency syndrome (aids) control programs. there have been failures as well, with very limited progress in human resources development of the public health workforce in low-income countries. the new public health is necessarily comprehensive in scope and it will continue to evolve as new technologies and scientific discoveries -biological, genetic, and sociological -reveal more methods of disease control and health promotion. it relates to or encompasses all community and individual activities directed towards improving the environment for health, reducing factors that contribute to the burden of disease, and fostering those factors that relate directly to improved health. its programs range broadly from immunization, health promotion, and child care, to food labeling and fortification, as well as to the assurance of well-managed, accessible health care services. a strong public health system should have adequate preparedness for natural and human-made disasters, as seen in the recent tsunamis, hurricanes, biological or other attacks by terrorists, wars, conflicts, and genocidal terrorism (box 2.2) . the concepts of health promotion and disease prevention are essential and fundamental elements of the new public health. parallel scientific advances in molecular biology, genetics and pharmacogenomics, imaging, information technology, computerization, biotechnology, and nanotechnology hold great promise for improving the productivity of the health care system. advances in technology with more effective and less expensive drug and vaccine development, with improved safety and effectiveness, and fewer adverse reactions, will over time greatly increase efficiency in prevention and treatment modalities. the new public health is important as a conceptual base for training and practice of public health. it links classical topics of public health with adaptation in the organization and financing of personal health services. it involves a changed paradigm of public health to incorporate new advances in political, economic, and social sciences. failure at the political level to appreciate the role of public health in disease control holds back many societies in economic and social development. at the same time, organized public health systems need to work to reduce inequities between and inside countries to ensure equal access to care. it also demands special attention through health promotion activities of all kinds at national and local societal levels to provide access for groups with special risks and needs to medical and community health care with the currently available and newly developing knowledge and technologies. the great gap between available capabilities to prevent and treat disease and actually reaching all in need is still the the mission of the nph is to maximize human health and well-being for individuals and communities, nationally and globally. the methods with which the nph works to achieve this are in keeping with recognized international best practices and scientific advances: 1. societal commitment and sustained efforts to maximize quality of life and health, economic growth with equity for all (health for all and health in all). collaboration between international, national, state, and local health authorities working with public and private sectors to promote health awareness and activities essential for population health. 3. health promotion of knowledge, attitudes, and practices, including legislation and regulation to protect, maintain, and advance individual and community health. 4. universal access to services for prevention and treatment of illness and disability, and promotion of maximum rehabilitation. 5. environmental, biological, occupational, social, and economic factors that endanger health and human life, addressing: (a) physical and mental illness, diseases and infirmity, trauma and injuries (b) local and global sanitation and environmental ecology (c) healthful nutrition and food security including availability, quality, safety, access, and affordability of food products (d) disasters, natural and human-made, including war, terrorism, and genocide (e) population groups at special risk and with specific health needs. 6. promoting links between health protection and personal health services through health policies and health systems management, recognizing economic and quality standards of medical, hospital, and other professional care in health of individuals and populations. 7. training of professional public health workforces and education of all health workers in the principles of ethical best practices of public health and health systems. 8. research and promotion of current best practices: wide application of current international best practices and standards. 9. mobilizing the best available evidence from local and international scientific and epidemiological studies and best practices recognized as contributing to the overall goal. 10. maintaining and promoting equity for individual and community rights to health with high professional and ethical standards. source of great international and internal national inequities. these inequities exist not only between developed and developing countries, but also within transition countries, mid-level developing countries, and those newly emerging with rapid economic development. the historical experience of public health will help to develop the applications of existing and new knowledge and societal commitment to social solidarity in implementation of the new discoveries for every member of the society, despite socioeconomic, ethnic, or other differences. political will and leadership in health, adequate financing, and organization systems in the health setting are crucial to furthering health as an objective with defined targets, supported by well-trained staff for planning, management, and monitoring the population health and functioning of health systems. political leadership and professional support are both indispensable in a world of limited resources, with high public expectations and the growing possibilities of effectiveness of public health programs. well-developed information and knowledge management systems are required to provide the feedback and information needed for good management. it includes responsibilities and coordination at all levels of government. non-governmental organizations (ngos) and participation of a well-informed media and strong professional and consumer organizations also have significant roles in furthering population health. no less important are clear designations of responsibilities of the individual for his or her own health, and of the provider of care for humane, high-quality professional care. the complexities and interacting factors are suggested in figure 2 .1, with the classic host-agent-environment triad. many changes have signaled a need for transformation towards the new public health. religion, although still a major political and policy-making force in many countries, is no longer the central organizing power in most societies. organized societies have evolved from large extended families and tribes to rural societies, cities, regions, and national governments. with the growth of industrialized urban communities, rapid transport, and extensive trade and commerce in multinational economic systems, the health of individuals and communities has become more than just a personal, family, and/or local problem. an individual is not only a citizen of the village, city, or country in which he or she lives, but a citizen of a "global village". the agricultural revolutions and international explorations of the fifteenth to seventeenth centuries that increased food supply and diversity were followed only much later by knowledge of nutrition as a public health issue. the scientific revolution of the seventeenth to nineteenth centuries provided the basics to describe and analyze the spread of disease and the poisonous effects of the industrial revolution, including crowded living conditions and pollution of the environment with serious ecological damage. in the latter part of the twentieth century, a new agricultural "green revolution" had a great impact in reducing human deprivation internationally, yet the full benefits of healthier societies are yet to be realized in the large populations living in abject poverty in sub-saharan africa, south-east asia, and other parts of the world. global water shortages can be addressed with new methods of irrigation, water conservation and the application of genetic sciences to food production, and issues of economics and food security are of great importance to a still growing world population with limited supplies. further, food production capacity can and must be enlarged to meet current food insecurity, rising expectations of developing nations, and population growth. the sciences of agriculture-related fields, including genetic sciences and practical technology, will be vital to human progress in the coming decades. these and other societal changes discussed in chapter 1 have enabled public health to expand its potential and horizons, while developing its pragmatic and scientific base. organized public health in the twentieth century proved effective in reducing the burden of infectious diseases and has contributed to improved quality of life and longevity by many years. in the last half-century, chronic diseases have become the primary causes of morbidity and mortality in the developed countries and increasingly in developing countries. growing scientific and epidemiological knowledge increases the capacity to deal with these diseases. many aspects of public health can only be influenced by the behavior of and risks to the health of individuals. these require interventions that are more complex and relate to societal, environmental, and community standards and expectations as much as to personal lifestyle. the dividing line between communicable and non-communicable diseases changes over time. scientific advances have shown the causation of chronic conditions by infectious agents and their prevention by curing the infection, as in helicobacter pylori and peptic ulcers, and in prevention of cancer of the liver and cervix by immunization for hepatitis b and human papillomavirus (hpv), respectively. chronic diseases have come to the center stage in the "epidemiological transition", as infectious diseases came under increasing control. this, in part, has created a need for reform in the funding and management of health systems due to rapidly rising costs, aging of the population, the rise of obesity and diabetes and other chronic conditions, mushrooming therapeutic technology, and expanding capacity to deal with public health emergencies. reform is also needed in international assistance to help less developed nations build the essential infrastructure to sustain public health in the struggle to combat aids, malaria, tuberculosis (tb), and the major causes of preventable infant, childhood, and motherhood-related deaths. the nearly universal recognition of the rights of people to have access to health care of acceptable quality by international standards is a challenge of political will and leadership backed up by adequate staffing with public health-trained staff and organizations. the challenges of the current global economic crisis are impacting social and health systems around the world. the interconnectedness of managing health systems is part of the new public health. setting the priorities and allocating resources to address these challenges requires public health training and orientation of the professionals and institutions participating in the policy, management, and economics of health systems. conversely, those who manage such institutions are recognizing the need for a wide background in public health training in order to fulfill their responsibilities effectively. concepts such as objectives, targets, priorities, cost-effectiveness, and evaluation have become part of the new public health agenda. an understanding of how these concepts evolved will help the future health provider or manager to cope with the complexities of mixing science, humanity, and effective management of resources to achieve higher standards of health, and to cope with new issues as they develop in the broad scope of the new public health for the twenty-first century, in what breslow called the "third public health era" of long and healthy quality of life (box 2.3). health can be defined from many perspectives, ranging from statistics on mortality, life expectancy, and morbidity rates to idealized versions of human and societal perfection, as in the world health organization's (who's) founding charter. the first public health era -the control of communicable diseases. second public health era -the rise and fall of chronic diseases. third public health era -the development of long and high-quality life. preamble to the constitution of the who, as adopted by the international health conference in new york in 1946 and signed by the representatives of 61 states, entered into force on 7 april 1948, with the widely cited definition: "health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity". this definition is still important conceptually as an ideal accepted as fundamental to public policy over the years. a more operational definition of health is a state of equilibrium of the person with the biological, physical, and social environment, with the object of maximum functional capability. health is thus seen as a state characterized by anatomical, physiological, and psychological integrity, and an optimal functional capability in the family, work, and societal roles (including coping with associated stresses), a feeling of well-being, and freedom from risk of disease and premature death. deviances in health are referred to as unhealthy and constitute a disease nomenclature. there are many interrelated factors in disease and in their management through what is now called risk reduction. in 1878, claude bernard described the phenomenon of adaptation and adjustment of the internal milieu of the living organism to physiological processes. this concept is fundamental to medicine. it is also central to public health because understanding the spectrum of events and factors between health and disease is basic to the identification of contributory factors affecting the balance towards health, and to seeking the points of potential intervention to reverse the imbalance. as described in chapter 1, from the time of hippocrates and galen, diseases were thought to be due to humors and miasma or emanations from the environment. this was termed the miasma theory, and while without a direct scientific explanation, it was acted upon in the early to mid-nineteenth century and promoted by leading public health theorists including florence nightingale, with practical and successful measures to improve sanitation, housing, and social conditions, and having important results in improving health conditions. the competing germ theory developed by pioneering nineteenthcentury epidemiologists (panum, snow, and budd), scientists (pasteur, cohn, and koch), and practitioners (lister and semmelweiss) led to the science of bacteriology and a revolution in practical public health measures. the combined application of the germ (agent-host-environment) and miasma theories (social and sanitary environment) has been the basis of classic public health, with enormous benefits in the control of infectious and other diseases or harmful conditions. the revolutionary changes occurring since the 1960s have brought about a decline in cardiovascular and cancer mortality, and conceptual changes such as health for all and health in all to bring health issues to all policies at both governmental and individual levels. the concepts of public health advanced with the 1974 marc lalonde health field concept (new perspectives on the health of canadians, 1974) , stating that health was the result of the physical and social environment, lifestyle and personal habits, genetics, as well as organization and provision of medical care. the lalonde report was a key concept leading to ideas advanced at the alma-ata conference on primary care held in 1978 and more explicitly in the development of the basis for health promotion as articulated in the ottawa charter of 1986 on health promotion. this marked the beginning of a whole new aspect of public health, which proved itself in addressing with considerable success the epidemic of hiv and cardiovascular diseases. in the usa, the surgeon general's reports of 1964 on smoking and health, and of 1979 defining health targets as national policy promoted the incorporation of "management by objectives" from the business world applied to the health sector (see chapter 12). this led to healthy people usa 2000 and later versions, and the united nations (un) millennium development goals (mdgs), aimed primarily at the middle-and low-income countries (box 2.4). the identification of infectious causes of cancers of the liver and cervix established a new paradigm in epidemiology, and genetic epidemiology has important potential for public health and clinical medicine. in the basic host-agent-environment paradigm, a harmful agent comes through a sympathetic environment into contact with a susceptible host, causing a specific disease. this idea dominated public health thinking until the midtwentieth century. the host is the person who has or is at risk for a specific disease. the agent is the organism or direct cause of the disease. the environment includes the external factors which influence the host, his or her susceptibility to the agent, and the vector which transmits or carries the agent to the host from the environment. this explains the causation and transmission of many diseases. this paradigm (figure 2. 2), in effect, joins together the contagion and miasma theories of disease causation. a specific agent, a method of transmission, and a susceptible host are involved in an interaction, which are central to the infectivity or severity of the disease. the environment can provide the carrier or vector of an infective (or toxic) agent, and it also contributes factors to host susceptibility; for example, unemployment, poverty, or low education level. the expanded host-agent-environment paradigm widens the definition of each of the three components ( figure 2 .3), in relation to both acute infectious and chronic noninfectious disease epidemiology. in the latter half of the twentieth century, this expanded host-agent-environment paradigm took on added importance in dealing with the complex of factors related to chronic diseases, now the leading causes of disease and premature mortality in the developed world, and increasingly in developing countries. interventions to change host, environmental, or agent factors are the essence of public health. in infectious disease control, the biological agent may be removed by pasteurization of food products or filtration and disinfection (chlorination) of water supplies to prevent transmission of waterborne disease. the host may be altered by immunization to provide immunity to a specific infective organism. the environment may be changed to prevent transmission by destroying the vector or its reservoir of the disease. a combination of these interventions can be used against a specific risk factor, toxic or nutritional deficiency, infectious organism, or disease process. vaccine-preventable diseases may require both routine and special activities to boost herd immunity to protect the individual and the community. for other infectious diseases for which there is no vaccine (e.g., malaria), control involves a broad range of activities including case finding and treatment to improve the individual's health and to reduce the reservoir of the disease in the population, and other measures such as bed nets to reduce exposure of the host to vector mosquitoes, as well as vector control to reduce the mosquito population. tb control requires not only case finding and treatment, but understanding the contributory factors of social conditions, diseases with tb as a secondary condition (substance abuse and aids), agent resistance to treatment, and the inability of patients or carriers to complete treatment without supervision. sexually transmitted infections (stis) which are not controllable by vaccines require a combination of personal behavior change, health education, medical care, and skilled epidemiology. with non-infectious diseases, intervention is even more complex, involving human behavior factors and a wide range of legal, administrative, and educational issues. there may be multiple risk factors, which have a compounding effect in disease causation, and they may be harder to alter than infectious diseases factors. for example, smoking in and of itself is a risk factor for lung cancer, but exposure to asbestos fibers has a compounding effect. preventing exposure to the compounding variables may be easier than smoking cessation. reducing trauma morbidity and mortality is equally problematic. the identification of a single specific cause of a disease is of great scientific and practical value in modern public health, enabling such direct interventions as the use of vaccines or antibiotics to protect or treat individuals from infection by a causative organism, toxin, deficiency condition, or social factor. the cumulative effects of several contributing or risk factors in disease causation are also of great significance in many disease processes, in relation to infectious diseases such as nutritional status as for chronic diseases such as the cardiovascular group. the health of an individual is affected by risk factors intrinsic to that person as well as by external factors. intrinsic factors include the biological ones that the individual inherits and those life habits he or she acquires, such as smoking, overeating, or engaging in other high-risk behaviors. external factors affecting individual health include the environment, the socioeconomic and psychological state of the person, the family, and the society in which he or she lives. education, culture, and religion are also contributory factors to individual and community health. there are factors that relate to health of the individual in which the society or the community can play a direct role. one of these is provision of medical care. another is to ensure that the environment and community services include safety factors that reduce the chance of injury and disease, or include protective measures; for example, fluoridation of a community water supply to improve dental health, and seat-belt or helmet laws to reduce motor vehicle injury and death. these modifying factors may affect the response of the individual or the spread of an epidemic (see chapter 3). an epidemic may also include chronic disease, because common risk factors may cause an excess of cases in a susceptible population group, in comparison to the situation before the risk factor appeared, or in comparison to a group not exposed to the risk factor. these include rapid changes or "epidemics" in such conditions as type 2 diabetes, asthma, cardiovascular diseases, trauma, and other non-infectious disorders. disease is a dynamic process, not only of causation, but also of incubation or gradual development, severity, and the effects of interventions intended to modify outcome. knowledge of the natural history of disease is fundamental to understanding where and with what means intervention can have the greatest chance for successful interruption or change in the disease process for the patient, family, or community. the natural history of a disease is the course of that disease from beginning to end. this includes the factors that relate to its initiation; its clinical course leading up to resolution, cure, continuation, or long-term sequelae (further stages or complications of a disease); and environmental or intrinsic (genetic or lifestyle) factors and their effects at all stages of the disease. the effects of intervention at any stage of the disease are part of the disease process (figure 2 .4). as discussed above, disease occurs in an individual when agent, host, and environment interact to create adverse conditions of health. the agent may be an infectious organism, a chemical exposure, a genetic defect, or a deficiency condition. a form of individual or social behavior, such as reckless driving or risky sexual behavior, may lead to injury or disease. the host may be immune or susceptible as a result of many contributing social and environmental factors. the environment includes the vector, which may be a malaria-bearing mosquito, a contaminated needle shared by drug users, lead-contaminated paint, or an abusive family situation. assuming a natural state of "wellness" -i.e., optimal health or a sense of well-being, function, and absence of disease -a disease process may begin with the onset of a disease, infectious or non-infectious, following a somewhat characteristic pattern of "incubation" described by clinicians and epidemiologists. preclinical or predisposing events may be detected by a clinical history, with determination of risk including possible exposure or presence of other risk factors. interventions, before and during the process, are intended to affect the later course of the disease. the clinical course of a disease, or its laboratory or radiological findings, may be altered by medical or public health intervention, leading to the resolution or continuation of the disease with fewer or less severe secondary sequelae. thus, the intervention becomes part of the natural history of the disease. the natural history of an infectious disease in a population will be affected by the extent of prior vaccination or previous exposure in the community. diseases particular to children are often so because the adult population is immune from previous exposure or vaccinations. measles and diphtheria, primarily childhood diseases, now affect adults to a large extent because they are less protected by naturally acquired immunity or are vulnerable when their immunity wanes naturally or as a result of inadequate vaccination in childhood. in chronic disease management, high costs to the patient and the health system accrue where preventive services or management are inadequate, not yet available, or inaccessible or where there is a failure to apply the necessary interventions. the progress of diabetes to severe complications such as cardiovascular, renal, and ocular disease is delayed or reduced by good management of the condition, with a combination of smoking cessation, diet, exercise, and medications with good medical supervision. the patient with advanced chronic obstructive pulmonary disease or congestive heart failure may be managed well and remain stable with smoking avoidance, careful management of medications, immunizations against influenza and pneumonia, and other prevention-oriented care needs. where these are not applied or if they fail, the patient may require long and expensive medical and hospital care. failure to provide adequate supportive care will show up in ways that are more costly to the health system and will prove more life-threatening to the patient. the goal is to avoid where possible the necessity for tertiary care, substituting tertiary prevention, i.e., supportive rehabilitation to maximum personal function and maintaining a stable functional status. as in an individual, the phenomenon of a disease in a population may follow a course in which many factors interplay, and where interventions affect the natural course of the disease. the epidemiological patterns of an infectious disease can be assessed in their occurrence in the population or their mortality rates, just as they can for individual cases. the classic mid-nineteenth-century description of measles in the faroe islands by panum showed the transmission and the epidemic nature of the disease as well as the protective effect of acquired immunity (see chapter 1). similar, more recent breakthroughs in medical, epidemiological, biological, and social sciences have produced enormous benefit for humankind as discussed throughout this text, with some examples. these include the eradication of smallpox and in the coming years, poliomyelitis, measles, leprosy, and other dreaded diseases known for millennia; the near-elimination of rheumatic heart disease and peptic ulcers in the industrialized countries; vast reduction in mortality from stroke and coronary heart disease (chd); and vaccines (against hepatitis b and hpv) for the prevention of cancers. these and other great achievements of the twentieth and early part of the twenty-first centuries hold great promise for humankind in the coming decades, but great challenges lie ahead as well. the biggest challenge is to bring the benefits of known public health capacity to the poorest population of each country and the poorest populations globally. in developed countries a major challenge is to renew efforts of public health capacity to bear on prevention of chronic conditions such as diabetes and obesity, considered to be at pandemic proportions; and the individual and societal effects of mental diseases. in public health today, fears of a pandemic of avian influenza are based on transmission of avian or other animal-borne (zoonotic) prions or viruses to humans and then their adaptation permitting human-to-human spread. with large numbers of people living in close contact with many animals (wild and domestic fowl), such as in china and south-east asia, and rapid transportation around the world, the potential for global spread of disease is almost without historical precedent. indeed, many human infectious diseases are zoonotic in origin and transferred from natural wildlife reservoirs to humans either directly or via domestic or other wild animals, such as from birds to chickens to humans in avian influenza. monitoring or immunization of domestic animals requires a combination of multidisciplinary zoonotic disease management strategies, public education and awareness, and veterinary public health monitoring and control. rift valley fever, equine encephalitis, and more recently sars and avian influenza associated with bird-borne viral disease which can affect humans, each show the terrible dangers of pandemic diseases. ebola virus is probably sustained between outbreaks among fruit bats, or as recently suggested wild or domestic pigs, and may become a major threat to public health as human case fatality rates decline, meaning that patients and carriers, or genetic drift of the virus with possible airborne transmission, may spread this deadly disease more widely than in the past (see chapter 4). the health of populations, like the health of individuals, depends on societal factors no less than on genetics, personal risk factors, and medical services. social inequalities in health have been understood and documented in public health over the centuries. the chadwick and shattuck reports of 1840-1850 documented the relationship of poverty and bad sanitation, housing, and working conditions with high mortality, and ushered in the idea of social epidemiology. political and social ideologies thought that the welfare state, including universal health care systems of one type or another, would eliminate social and geographic differences in health status and this is in large part true. from the introduction of compulsory health insurance in germany in the 1880s to the failed attempt in the usa at national health insurance in 1995 (see chapters 1, 10 and 13) and the more recent achievements of us president obama in 2010-2011, social reforms to deal with inequalities in health have focused on improving access to medical and hospital care. almost all industrialized countries have developed such systems, and the contribution of these programs to improve health status has been an important part of social progress, especially since world war ii. but even in societies with universal access to health care, people of lower socioeconomic status (ses) suffer higher rates of morbidity and mortality from a wide variety of diseases. the black report (douglas black) in the uk in the early 1980s pointed out that the class v population (unskilled laborers) had twice the total and specific mortality rates of the class i population (professional and business) for virtually all disease categories, ranging from infant mortality to death from cancer. the report was shocking because all britons have had access to the comprehensive national health service (nhs) since its inception in 1948, with access to a complete range of services at no cost at time of service, close relations to their general practitioners, and good access to specialty services. these findings initiated reappraisals of the social factors that had previously been regarded as the academic interests of medical sociologists and anthropologists and marginal to medical care. more recent studies and reviews of regional, ethnic, and socioeconomic differentials in patterns of health care access, morbidity, and mortality indicate that health inequities are present in all societies including the uk, the usa, and others, even with universal health insurance or services. the ottawa charter on health promotion in 1986 placed a new paradigm before the world health community that recognized social and political factors as no less important ion health that traditional medical and sanitary public health measures. these concepts helped the world health community to cope with new problems such as hiv/aidsfor which there was neither a medical cure nor a vaccine to prevent the disease. its control came to depend in the initial decades almost entirely on education and change in lifestyles, until the advent of the antiretroviral drugs in the 1990s. there is still no viable vaccine. although the epidemiology of cardiovascular disease shows the direct relationship of the now classic risk factors of stress, smoking, poor diet, and physical inactivity, differences in mortality from cardiovascular disease between different classes among british civil servants are not entirely explainable by these factors. the differences are also affected by social and economic issues that may relate to the psychological needs of the individual, such as the degree of control people have over their own lives. blue-collar workers have less control over their lives, their working life in particular, than their white-collar counterparts, and have higher rates of chd mortality than higher social classes. other work shows the effects of migration, unemployment, drastic social and political change, and binge drinking, along with protective effects of healthy lifestyle, religiosity, and family support systems in cardiovascular diseases. social conditions affect disease distribution in all societies. in the usa and western europe, tb has re-emerged as a significant public health problem in urban areas partly because of high-risk population groups, owing to poverty and alienation from society, as in the cases of homelessness, drug abuse, and hiv infection. in countries of eastern europe and the former soviet union, the recent rise in tb incidence has resulted from various social and economic factors in the early 1990s, including the large-scale release of prisoners. in both cases, diagnosis and prescription of medication are inadequate, and the community at large becomes at risk because of the development of antibioticresistant strains of tubercle bacillus readily spread by inadequately treated carriers, acting as human vectors. studies of ses and health are applicable and valuable in many settings. in alameda county, california, differences in mortality between black and white population groups in terms of survival from cancer became insignificant when controlled for social class. a 30-year follow-up study of the county population reported that low-income families in california are more likely than those on a higher income to have physical and mental problems that interfere with daily life, contributing to further impoverishment. studies of the association between indicators of ses and recent screening in the usa, australia, finland, and elsewhere showed that lower ses women use less preventive care such as papanicolaou (pap) smears for cervical cancer than women of higher ses, despite having greater risk for cervical cancer. many factors in ses inequalities are involved, including transportation and access to primary care, differences in health insurance coverage, educational levels, poverty, high-risk behaviors, social and emotional distress, feeling a lack of control over one's own life, employment, occupation, and inadequate family or community social support systems. many barriers exist owing to difficulties in access and the lack of availability of free or low-cost medical care, and the absence or limitations of health insurance is a further factor in the socioeconomic gradient. the recognition that health and disease are influenced by many factors, including social inequalities, plays a fundamental role in the new public health paradigm. health care systems need to take into account economic, social, physical, and psychological factors that otherwise will limit the effectiveness of even the best medical care. the health system includes access to competent and responsible primary care as well as by the wider health system, including health promotion, specific prevention and population-based health protection. the paradigm of the host-agent-environment triad (figures 2.2 and 2. 3) is profoundly affected by the wider context. the sociopolitical environment and organized efforts at intervention affect the epidemiological and clinical course of disease of the individual. medical care is essential, as is public health, but the persistent health inequities seen in most regions and countries require societal attention. success or failure in improving the conditions of life for the poor, and other vulnerable "risk groups", affect national or regional health status and health system performance. the health system is meant to reduce the occurrence or bad outcome of disease, either directly by primary prevention or treatment as secondary prevention or by maximum rehabilitation as tertiary prevention, or equally important indirectly by reducing community or individual risk factors. the the effects of social conditions on health can be partly offset by interventions intended to promote healthful conditions; for example, improved sanitation, or through good-quality primary and secondary health services, used efficiently and effectively made available to all. the approaches to preventing disease or its complications may require physical changes in the environment, such as removal of the broad street pump handle to stop the cholera epidemic in london, or altering diets as in goldberger's work on pellagra. some of the great successes of public health have been and continue to be low technology. examples, among many others, include insecticide-impregnated bednets and other vector control measures, oral rehydration solutions, treatment and cure of peptic ulcers, exercise and diet to reduce obesity, hand washing in hospitals (and other health facilities), community health workers, and condoms and circumcision for the prevention of stis, including hiv and cancer of the cervix. the societal context in terms of employment, social security, female education, recreation, family income, cost of living, housing, and homelessness is relevant to the health status of a population. income distribution in a wealthy country may leave a wide gap between the upper and lower socioeconomic groups, which affects health status. the media have great power to sway public perception of health issues by choosing what to publish and the context in which to present information to society. modern media may influence an individual's tendency to overestimate the risk of some health issues while underestimating the risk of others, ultimately influencing health choices, such as occurred with public concern regarding false claims of an association between the measles-mumps-rubella (mmr) vaccine and autism in the uk (see the wakefield effect, chapter 4). the new public health has an intrinsic responsibility for advocacy of improved societal conditions in its mission to promote optimal community health. an ultimate goal of public health is to improve health and to prevent widespread disease occurrence in the population and in an individual. the methods of achieving this are wide and varied. when an objective has been defined in "social justice is a matter of life and death. it affects the way people live, their consequent chance of illness, and their risk of premature death. we watch in wonder as life expectancy and good health continue to increase in parts of the world and in alarm as they fail to improve in others. a girl born today can expect to live for more than 80 years if she is born in some countries -but less than 45 years if she is born in others. within countries there are dramatic differences in health that are closely linked with degrees of social disadvantage. differences of this magnitude, within and between countries, simply should never happen. these inequities in health, avoidable health inequalities arise because of the circumstances in which people grow, live, work, and age, and the systems put in place to deal with illness. the conditions in which people live and die are, in turn, shaped by political, social, and economic forces. social and economic policies have a determining impact on whether a child can grow and develop to its full potential and live a flourishing life, or whether its life will be blighted. increasingly the nature of the health problems rich and poor countries have to solve are converging. the development of a society, rich or poor, can be judged by the quality of its population's health, how fairly health is distributed across the social spectrum, and the degree of protection provided from disadvantage as a result of ill-health." preventing disease, the next step is to identify suitable and feasible methods of achieving it, or a strategy with tactical objectives. this determines the method of operation, course of action, and resources needed to carry it out. the methods of public health are categorized as health promotion, and primary, secondary, and tertiary prevention (box 2.6). health promotion is the process of enabling people and communities to increase control over factors that influence their health, and thereby to improve their health (adapted from the ottawa charter of health promotion, 1986; box 2.7). health promotion is a guiding concept involving activities intended to enhance individual and community health and well-being (box 2.8). it seeks to increase involvement and control by the individual and the community in their own health. it acts to improve health and social welfare, and to reduce specific determinants of diseases and risk factors that adversely affect the health, well-being, and productive capacities of an individual or society, setting targets based on the size of the problem but also the feasibility of successful intervention, in a cost-effective way. this can be through direct contact with the patient or risk group, or act indirectly through changes in the environment, legislation, or public policy. control of aids relies on an array of interventions that promote change in sexual behavior and other contributory risks such as sharing of needles among drug users, screening of blood supply, safe hygienic practices in health care settings, and education of groups at risk such as teenagers, sex workers, migrant workers, and many others. control of aids is also a clinical problem in that patients need antiretroviral therapy (art), but this becomes a management and policy issue for making these drugs available and at an affordable price for the poor countries most affected. this is an example of the challenge and effectiveness of health promotion and the new public health. health promotion is a key element of the new public health and is applicable in the community, the clinic or hospital, and in all other service settings. some health promotion activities are government legislative and box 2.6 modes of prevention l health promotion -fostering national, community, and individual knowledge, attitudes, practices, policies, and standards conducive to good health; promoting legislative, social, or environmental conditions; promoting knowledge and practices for self-care that reduce individual and community risk; and creating a healthful environment. it is directed toward action on the determinants of health. l health protection -activities of official health departments or other agencies empowered to supervise and regulate food hygiene, community and recreational water safety, environmental sanitation, occupational health, drug safety, road safety, emergency preparedness, and many other activities to eliminate or reduce as much as possible risks of adverse consequences to health. l primary prevention -preventing a disease from occurring, e.g., vaccination to prevent infectious diseases, advice to stop smoking to prevent lung cancer. l secondary prevention -making an early diagnosis and giving prompt and effective treatment to stop progress or shorten the duration and prevent complications from an already existing disease process, e.g., screening for hypertension or cancer of cervix and colorectal cancer for early case finding, early care and better outcomes. l tertiary prevention -stopping progress of an already occurring disease, and preventing complications, e.g., in managing diabetes and hypertension to prevent complications; restoring and maintaining optimal function once the disease process has stabilized, e.g., promoting functional rehabilitation after stroke and myocardial infarction with long-term follow-up care. health promotion (hp) is the process of enabling people to increase control over, and to improve their health. hp represents a comprehensive social and political process, and not only embraces actions directed at strengthening the skills and capabilities of individuals. hp also undertakes action directed towards changing social, environmental, and economic conditions so as to alleviate their impact on public and individual health. health promotion is the process of enabling people to increase control over the determinants of health and thereby improve their health. participation is essential to sustain health promotion action. the ottawa charter identifies three basic strategies for health promotion. these are advocacy for health to create the essential conditions for health indicated above; enabling all people to achieve their full health potential; and mediating between the different interests in society in the pursuit of health. these strategies are supported by five priority action areas as outlined in the ottawa charter for health promotion: regulatory interventions such as mandating the use of seat belts in cars, requiring that children be immunized to attend school, declaring that certain basic foods must have essential minerals and vitamins added to prevent nutritional deficiency disorders in vulnerable population groups, and mandating that all newborns should be given prophylactic vitamin k to prevent hemorrhagic disease of the newborn. setting food and drug standards and raising taxes on cigarettes and alcohol to reduce their consumption are also part of health promotion. promoting a healthy lifestyle is a major known obesity-preventive activity. health promotion is provided by organizations and people with varied professional backgrounds working towards common goals of improvement in the health and quality of individual and community life. initiatives may come from government with dedicated allocation of funds to address specific health issues, from donors, or from advocacy or community groups or individuals to promote a specific or general cause in health. raising awareness to inform and motivate people about their own health and lifestyle factors that might put them at risk requires teaching young people about the dangers of sexually transmitted diseases, smoking, and alcohol abuse to reduce risks associated with their social behavior. it might include disseminating information on healthy nutrition; for example, the need for folic acid supplements for women of childbearing age and multiple vitamins for elderly, as well as the elements of a healthy diet, compliance with immunization recommendations, compliance with screening programs, and many others. community and peer group attitudes and standards affect individual behavior. health promotion endeavors to create a climate of knowledge, attitudes, beliefs, and practices that are associated with better health outcomes. international conferences following on from the ottawa charter were held in adelaide in 1988 , sundsvall in 1991 , jakarta in 1999 , mexico in 2000 , bangkok in 2005 , and nairobi in 2009 . the principles of health promotion have been reiterated and have influenced public policy regarding public health as well as the private sector. health promotion has a track record of proven success in numerous public health issues where a biomedical solution was not available. the hiv/aids pandemic from the 1980s until the late 1990s had no medical treatment and control measures relied on screening, education, lifestyle changes, and supportive care. health promotion brought forward multiple interventions, from condom use and distribution, to needle exchanges for intravenous drug users, to male circumcision in high-prevalence african countries. medical treatment was severely limited until art was developed. the success of art also depends on a strong element of health promotion in widening the access to treatment and the success of medications to reduce transmission, most remarkably in reducing maternal-fetal transmission (see chapter 4). similarly, in the battle against cardiovascular diseases, health promotion was an instrumental factor in raising public awareness of the importance of management of hypertension and smoking reduction, dietary restraint, and physical exercise. the success of massive reductions in stroke and chd mortality is as much the result of health promotion as of improved medical care (see chapter 5). the character of public health carries with it a "good cop, bad cop" dichotomy. the "good cop" is persuasive and educational trying to convince people to do the right thing in looking after their own health: diet, exercise, smoking cessation, and others. on the other side, the "bad cop" role is regulatory and punitive. public health has a serious responsibility and role in the enforcement of laws and regulation to protect the public health. some of these are restrictive box 2.8 elements of health promotion 1. address the population as a whole in health-related issues, in everyday life as well as people at risk for specific diseases. 2. direct action to risk factors or causes of illness or death. 3. undertake activist approach to seek out and remedy risk factors in the community that adversely affect health. 4. promote factors that contribute to a better condition of health of the population. 5. initiate actions against health hazards, including communication, education, legislation, fiscal measures, organizational change, community development, and spontaneous local activities. 6. involve public participation in defining problems and deciding on action. 7. advocate relevant environmental, health, and social policy. 8. encourage health professional participation in health education and health advocacy. 9. advocate for health based on human rights and solidarity. 10. invest in sustainable policies, actions, and infrastructure to address the determinants of health. 11. build capacity for policy development, leadership, health promotion practice, knowledge transfer and research, and health literacy. 12. regulate and legislate to ensure a high level of protection from harm and enable equal opportunity for health and well-being for all people. 13. partner and build alliances with public, private, nongovernmental, and international organizations and civil society to create sustainable actions. 14. make the promotion of health central to the global development agenda. of individual rights that may damage other people or are requirements based on strong evidence of benefits to population health. readily accepted are food and drug standards, such as pasteurization of milk, and iodization of salt; requirements to drive on the right-hand side of the road (except in some countries such as the uk), to wear seat belts and for motorcyclists to wear safety helmets; and not smoking in public places. enforcement of these and similar statutory or regulatory requirements is vital in a civil society to protect the public from health hazards and to protect people from harm and exploitation by unscrupulous manufacturers and marketing. cigarette advertising and sponsorship of sports events by tobacco companies are banned in most upper income countries. the use of transfats in food manufacturing and baking is now banned and salt reduction is being promoted and even mandated in many us local authorities to reduce cardiovascular disease. advertising of unhealthy snack foods on children's television programs and during child-watching hours is commonly restricted. banning high-sugar soda drink distribution in schools is a successful intervention to reduce the current child obesity epidemic. melamine use in milk powders and baby formulas, which caused widespread illness and death of infants in china, is now banned and a punishable offence for manufacture or distribution in china and worldwide. examples of this aspect of public health are mentioned throughout this text, especially in chapters 8 and 9 on nutrition, and environmental and occupational health, respectively. the regulatory enforcement function of public health is sometimes controversial and portrayed as interference with individual liberty. fluoridation of community water supplies is an example where aggressive lobby groups opposing this safe and effective public health measure are still common. this is discussed in chapter 7. equally important is the public health policy issue of resource allocation and taxation for health purposes. taxation is an unpopular measure that governments must employ and enforce in order to do the public's business. the debate over the patient protection and affordable care act 2010 (ppaca or "obamacare"), discussed elsewhere in this and other chapters, shows how bitter the arguments can become, yet the goal of equality of access to health care cannot be denied as a public good, demonstrably contributing to the health of the nation. primary prevention refers to those activities that are undertaken to prevent disease or injury from occurring at all. primary prevention works with both the individual and the community. it may be directed at the host to increase resistance to the agent (such as in immunization or cessation of smoking), or at environmental activities to reduce conditions favorable to the vector for a biological agent, such as mosquito vectors of malaria or dengue fever. landmark examples include the treatment and prevention of scurvy among sailors based on james lind's findings in a classic clinical epidemiological study in 1747, and john snow's removal of the handle from the broad street pump to stop a cholera epidemic in london in 1854 (see chapter 1). primary prevention includes elements of health protection such as ensuring water, food and drug, and workplace safety; chlorination of drinking water to prevent transmission of waterborne enteric diseases; pasteurization of milk to prevent gastrointestinal diseases; mandating wearing seat belts in motor vehicles to prevent serious injury and death in road crashes; and reducing the availability of firearms to reduce injury and death from intentional, accidental, or random violence. it also includes direct measures to prevent diseases, such as immunization to prevent polio, tetanus, pertussis, and diphtheria. health promotion and health protection blend together as a group of activities that reduce risk factors and diseases through many forms of intervention such as changing smoking legislation or preventing birth defects by fortification of flour with folic acid. prevention of hiv transmission by needle exchange for intravenous drug users, promoting condom usage, and promoting male circumcision in africa, and the distribution of condoms and clean needles for hivpositive drug users are recent examples of primary prevention associated with health promotion programs. primary prevention also includes activities within the health system that can lead to better health. this may mean, for example, setting standards and to reduce hospital infections, and ensuring that doctors not only are informed of appropriate immunization practices and modern prenatal care or screening programs for cancer of the cervix, colon, and breast, but also are aware of their vital role in preventing cardiovascular and other non-communicable diseases. in this role, the health care provider serves as a teacher and guide, as well as a diagnostician and therapist. like health promotion, primary prevention does not depend on health care providers alone; health promotion works to increase individual and community consciousness of self-care, mainly by raising awareness and information levels and empowering the individual and the community to improve self-care, to reduce risk factors, and to live healthier lifestyles. secondary prevention is early diagnosis and management to prevent complications from a disease. public health interventions to prevent the spread of disease include the identification of sources of the disease and the implementation of steps to stop it, as shown in snow's closure of the broad street pump. secondary prevention includes steps to isolate cases and treat or immunize contacts so as to prevent further cases of meningitis or measles, for example, in outbreaks. for current epidemics such as hiv/aids, primary prevention is largely based on education, abstinence from any and certainly risky sexual behavior, circumcision, and treatment of patients in order to improve their health and to reduce the risk of spread of hiv. for high-risk groups such as intravenous drug users, needleexchange programs reduce the risk of spread of hiv, and hepatitis b and c. distribution of condoms to teenagers, military personnel, truck drivers, and commercial sex workers helps to prevent the spread of stis and aids in schools and colleges, as well as among the military. the promotion of circumcision is shown to be effective in reducing the transmission of hiv and of hpv (the causative organism for cancer of the cervix). all health care providers have a role in secondary prevention; for example, in preventing strokes by early identification and adequate care of hypertension. the child who has an untreated streptococcal infection of the throat may develop complications which are serious and potentially life-threatening, including rheumatic fever, rheumatic valvular heart disease, and glomerulonephritis. a patient found to have elevated blood pressure should be advised about continuing management by appropriate diet and weight loss if obese, regular physical exercise, and long-term medication with regular follow-up by a health provider in order to reduce the risk of stroke and other complications. in the case of injury, competent emergency care, safe transportation, and good trauma care may reduce the chance of death and/or permanent handicap. screening and high-quality care in the community prevent complications of diabetes, including heart, kidney, eye, and peripheral vascular disease. they can also prevent hospitalizations, amputations, and strokes, thus lengthening and improving the quality of life. health care systems need to be actively engaged in secondary prevention, not only as individual doctors' services, but also as organized systems of care. public health also has a strong interest in promoting highquality care in secondary and tertiary care hospital centers in such areas of treatment as acute myocardial infarction, stroke, and injury in order to prevent irreversible damage. measures include quality of care reviews to promote adequate longterm postmyocardial infarction care with aspirin and betablockers or other medication to prevent or delay recurrence and second or third myocardial infarctions. the role of highquality transportation and care in emergency facilities of hospitals in public health is vital to prevent long-term damage and disability; thus, cardiac care systems including publicly available defibrillators, catheterization, the use of stents, and bypass procedures are important elements of health care policy and resource allocation, which should be accessible not only in capital cities but also to regional populations. tertiary prevention involves activities directed at the host or patient, but also at the social and physical environment in order to promote rehabilitation, restoration, and maintenance of maximum function after the disease and its complications have stabilized. the person who has undergone a cerebrovascular accident or trauma will reach a stage where active rehabilitation can help to restore lost functions and prevent recurrence or further complications. the public health system has a direct role in the promotion of disability-friendly legislation and standards of building, housing, and support services for chronically ill, handicapped, and elderly people. this role also involves working with many governmental social and educational departments, but also with advocacy groups, ngos, and families. it may also include the promotion of disability-friendly workplaces and social service centers. treatment for conditions such as myocardial infarction or a fractured hip now includes early rehabilitation in order to promote early and maximum recovery with restoration to optimal function. the provision of a wheelchair, walkers, modifications to the home such as special toilet facilities, doors, and ramps, along with transportation services for paraplegics are often the most vital factors in rehabilitation. public health agencies work with groups in the community concerned with promoting help for specific categories of risk group, disease, or disability to reduce discrimination. community action is often needed to eliminate financial, physical, or social barriers, promote community awareness, and finance special equipment or other needs of these groups. close follow-up and management of chronic disease, physical and mental, require home care and ensuring an appropriate medical regimen including drugs, diet, exercise, and support services. the follow-up of chronically ill people to supervise the taking of medications, monitor changes, and support them in maximizing their independent capacity in activities of daily living is an essential element of the new public health. public health uses a population approach to achieve many of its objectives. this requires defining the population, including trends of change in the age and gender distribution of the population, fertility and birth rates, spread of disease and disability, mortality, marriage and migration, and socioeconomic factors. the reduction of infectious disease as the major cause of mortality, increased longevity coupled with declining fertility rates, resulted in changes in the age composition, or a demographic transition. demographic changes, such as fertility and mortality patterns, are important factors in changing the age distribution of the population, resulting in a greater proportion of people surviving to older ages. declining infant mortality, increasing educational levels of women, the availability of birth control, and other social and economic factors lead to changes in fertility patterns and the demographic transition -an aging of the population -with important effects on health service needs. the age and gender distribution of a population affects and is affected by patterns of disease. change in epidemiological patterns, or an epidemiological shift, is a change in predominant patterns of morbidity and mortality. the transition of infectious diseases becoming less prominent as causes of morbidity and mortality and being replaced by chronic and non-infectious diseases has occurred in both developed and developing countries. the decline in mortality from chronic diseases, such as cardiovascular disease, represents a new stage of epidemiological transition, creating an aging population with higher standards of health but also long-term community support and care needs. monitoring and responding to these changes are fundamental responsibilities of public health, and a readiness to react to new, local, or generalized changes in epidemiological patterns is vital to the new public health. societies are not totally homogeneous in ethnic composition, levels of affluence, or other social markers. on one hand, a society classified as developing may have substantial numbers of people with incomes that promote overnutrition and obesity, so that disease patterns may include increasing prevalence of diseases of excesses, such as diabetes. on the other hand, affluent societies include population groups with disease patterns of poverty, including poor nutrition and low birth-weight babies. a further stage of epidemiological transition has been occurring in the industrialized countries since the 1960s, with dramatic reductions in mortality from chd, stroke and, to a lesser extent, trauma. the interpretation of this epidemiological transition is still not perfectly clear. how it occurred in the industrialized western countries but not in those of the former soviet union is a question whose answer is vital to the future of health in russia and some countries of eastern europe. developing countries must also prepare to cope with increasing epidemics of non-infectious diseases, and all countries face renewed challenges from infectious diseases with antibiotic resistance or newly appearing infectious agents posing major public health threats. demographic change in a country may reflect social and political decisions and health system priorities from decades before. russia's rapid population decline since the 1990s, china's gender imbalance with a shortage of millions of young women, egypt's rapid population growth outstripping economic capacity, and many other examples indicate the severity and societal importance of capacity to analyze and formulate public health and social policies to address such fundamental sociopolitical issues. aging of the population is now the norm in most developed countries as a result of low birth and declining mortality rates. this change in the age distribution of a population has many associated social and economic issues as to the future of social welfare with a declining age cohort to provide the workforce. the aging population requires pension and health care support which make demands of social security systems that will depend on economic growth with a declining workforce. in times of economic stress, as in europe, this situation is made more difficult by longstanding short working weeks, early pension ages, and high social benefits. however, this results in unemployment among young people in particular and social conflict. the interaction of increasing life expectancy and a declining workforce is a fundamental problem in the high-income countries. this imbalance may be resolved in part through productivity gains and switching of primary production to countries with large still underutilized workforces, while employment in the developed countries will depend on service industries including health and the economic growth generated by higher technology and intellectual property and service industries. the challenge of keeping populations and individuals healthy is reflected in modern health services. each component of a health service may have developed with different historical emphases, operating independently as a separate service under different administrative auspices and funding systems, competing for limited health care resources. in this situation, preventive community care receives less attention and resources than more costly treatment services. figure 2 .5 suggests a set of health services in an interactive relationship to serve a community or defined population, but the emphasis should be on the interdependence of these services with one other and with the comprehensive network in order to achieve effective use of resources and a balanced set of services for the patient, the client or patient population, and the community. clinical medicine and public health each play major roles in primary, secondary, and tertiary prevention. each may function separately in their roles in the community, but optimal success lies in their integrated efforts. allocation of resources should promote management and planning practices to assist this integration. there is a functional interdependence of all elements of health care serving a definable population. the patient should be the central figure in the continuum or complex of services available. effectiveness in use of resources means that providing the service most appropriate for meeting the individual's or group's needs at a point in time are those that should be applied. this is the central concept in currently developing innovations in health care delivery in the usa with organizations using terms such as patient centered medical home, accountable care organizations (acos), and population health management systems, which are being promoted in the obamacare health reforms now in process (see chapter 10) (shortell et al., 2010) . separate organization and financing of services place barriers to appropriate provision of services for both the community and the individual patient. the interdependence of services is a challenge in health care organizations for the future. where there is competition for limited resources, pressures for tertiary services often receive priority over programs to prevent children from dying of preventable diseases. public health must be seen in the context of all health care and must play an influential role in promoting prevention at all levels. clinical services need public health in order to provide prevention and community health services that reduce the burden of disease, disability, and dependence on the institutional setting. health was traditionally thought of as a state of absence of disease, pain, or disability, but has gradually been expanded to include physical, mental, and societal well-being. in 1920, c. e. a. winslow, professor of public health at yale university, defined public health as follows: "public health is the science and art of (1) preventing disease, (2) prolonging life, and (3) winslow's far-reaching definition remains a valid framework but is unfulfilled when clinical medicine and public health have financing and management barriers between them. in many countries, isolation from the financing and provision of medical and nursing care services left public health with the task of meeting the health needs of the indigent and underserved population groups with inadequate resources and recognition. health insurance organizations for medical and hospital care have in recent years been more open to incorporating evidence-based preventive care, but the organization of public health has lacked the same level of attention. in some countries, the limitations have been conceptual in that public health was defined primarily in terms of control of infectious, environmental, and occupational diseases. a more recent and widely used definition is: "public health is the science and art of preventing disease, prolonging life, and promoting health through the organized efforts of society." this definition, coined in 1988 in the public health in england report by sir donald acheson, reflects the broad focus of modern public health. terms such as social hygiene, preventive medicine, community medicine, and social medicine have been used to denote public health practice over the past century. preventive medicine is the application of preventive measures by clinical practitioners combining some elements of public health with clinical practice relating to individual patients. preventive medicine defines medical or clinical personal preventive care, with stress on risk groups in the community and national efforts for health promotion. the focus is on the health of defined populations to promote health and well-being using evidence-based guidelines for cost-effective preventive measures. measures emphasized include screening and follow-up of chronic illnesses, and immunization programs; for example, influenza and pneumococcal pneumonia vaccines are used by people who are vulnerable because of their age, chronic diseases, or risk of exposure, such as medical and nursing personnel and those providing other personal clinical services. clinical medicine also deals in the area of prevention in the management of patients with hypertension or diabetes, and in doing so prevents the serious complications of these diseases. social medicine is also primarily a medical specialty which looks at illness in an individual in the family and social context, but lacks the environmental and regulatory and organized health promotion functions of public health. community health implies a local form of health intervention, whereas public health more clearly implies a global approach, which includes action at the international, national, state, and local levels. some issues in health can be dealt with at the individual, family, or community level; others require global strategies and intervention programs with regional, national, or international collaboration and leadership. the social medicine movement originated to address the harsh conditions of the working population during the industrial revolution in mid-nineteenth-century europe. an eminent pioneer in cellular pathology, rudolph virchow provided leadership in social medicine powered by the revolutionary movements of 1848, and subsequent social democrat political movements. their concern focused on harsh living and health conditions among the urban poor working class and neglectful political norms of the time. social medicine also developed as an academic discipline and advocacy orientation by providing statistical evidence showing, as in various governmental reports in the mid-nineteenth century, that poverty among the working class was associated with short life expectancy and that social conditions were key factors in the health of populations and individuals. this movement provided the basis for departments in medical faculties and public health education throughout the world stressing the close relationship between political priorities and health status. this continued in the twentieth century and in the usa found expression in pioneering work since the 1940s at montefiore hospital in new york and with victor sidel, founding leader of the community health center movement the usa from the 1960s. in the twenty-first century this movement continues to emphasize relationships between politics, society, disease, and medicine, and forms of medical practice derived from it, as enunciated by prominent advocates such as harvardbased paul farmer in haiti, russia and rwanda, and in the uk by martin mckee and others (nolte and mckee, 2008) . similar concepts are current in the usa under headings such as family medicine, preventive medicine, and social medicine. this movement has also influenced sir michael marmot and others in the world health commission of health inequalities of 2008, with a strong influence on the un initiative to promote mdgs, whose first objective is poverty reduction (commission on inequalities report 2010). application of the idea of poverty reduction as a method of reducing health inequalities has been successful recently in a large field trial in brazil showing greater reduction in child mortality where cash bonuses were awarded by municipalities for the poor families than that observed in other similar communities (rasella, 2013). in the usa, this movement is supported by increased health insurance coverage for the working poor, with funding for preventive care and incentives for community health centers in the obamacare plan of 2010 for implementation in the coming years to provide care for uninsured and underserved populations, particularly in urban and rural poverty areas. the political aspect of social medicine is the formulation of and support for national initiatives to widen health care coverage to the 16 percent of the us population who are still uninsured, and to protect those who are arbitrarily excluded owing to previous illnesses, caps on coverage allowed, and other exploitative measures taken by private insurance that frequently deny americans access to the high levels of health care available in the country. the ethical base of public health in europe evolved in the context of its successes in the nineteenth and early twentieth centuries along with ideas of social progress. but the twentieth century was also replete with extremism and wide-scale abuse of human rights, with mass executions, deportations, and starvation as official policy in fascist and stalinist regimes. eugenics, a pseudoscience popularized in the early decades of the twentieth century, promoted social policies meant to improve the hereditary qualities of a race by methods such as sterilization of mentally handicapped people. the "social and racial hygiene" of the eugenics movements led to the medicalization of sterilization in the usa and other countries. this was adopted and extended in nazi germany to a policy of murder, first of the mentally and physically handicapped and then of "racial inferiors". these eugenics theories were widely accepted in the medical community in germany, then used by the nazi regime to justify medically supervised killing of hundreds of thousands of helpless, incapacitated individuals. this practice was linked to wider genocide and the holocaust, with the brutalization and industrialized murder of over 6 million jews and 6 million other people, and corrupt medical experimentation on prisoners. following world war ii, the ethics of medical experimentation (and public health) were codified in the nuremberg code and universal declaration of human rights based on lessons learned from these and other atrocities inflicted on civilian populations (see chapter 15). threats of genocide, ethnic cleansing, and terrorism are still present on the world stage, often justified by current warped versions of racial hygienic theories. genocidal incitement and actual genocide and terrorism have recurred in the last decades of the twentieth century and into the twenty-first century in the former yugoslav republics, africa (rwanda and darfur), south asia, and elsewhere. terrorism against civilians has become a worldwide phenomenon with threats of biological and chemical agents, and potentially with nuclear capacity. asymmetrical warfare of insurgencies which use innocent civilians for cover, as with other forms of warfare, carries with it grave dangers to public health, human rights, and international stability, as seen in the twenty-first century in south sudan, darfur, dr congo, chechnya, iraq, afghanistan, and pakistan. in 1961, kerr white and colleagues defined medical ecology as population-based research providing the foundation for management of health care quality. this concept stresses a population approach, including those not attending and those using health services. this concept was based on previous work on quality of care, randomized clinical trials, medical audit, and structure-process-outcome research. it also addressed health care quality and management. these themes influenced medical research by stressing the population from which clinical cases emerge as well as public health research with clinical outcome measures, themes that recur in the development of health services research and, later, evidence-based medicine. this led to the development of the agency for health care policy and research and development in the us department of health and human services and evidence-based practice centers to synthesize fundamental knowledge for the development of information for decision-making tools such as clinical guidelines, algorithms, or pathways. clinical guidelines and recommended best practices have become part of the new public health to promote quality of patient care and public health programming. these can include recommended standards; for example, follow-up care of the postmyocardial infarction patient, an internationally recommended immunization schedule, recommended dietary intake or food fortification standards, and mandatory vitamin k and eye care for all newborns and many others (see chapter 15). community-oriented primary care (copc) is an approach to primary health care that links community epidemiology and appropriate primary care, using proactive responses to the priority needs identified. copc, originally pioneered in south africa and israel by sidney and emily kark and colleagues in the 1950s and 1960s, stresses medical services in the community which need to be adapted to the needs of the population as defined by epidemiological analysis. copc involves community outreach and education, as well as clinical preventive and treatment services. copc focuses on community epidemiology and an active problem-solving approach. this differs from national or larger scale planning that sometimes loses sight of the local nature of health problems or risk factors. copc combines clinical and epidemiological skills, defines needed interventions, and promotes community involvement and access to health care. it is based on linkages between the different elements of a comprehensive basket of services along with attention to the social and physical environment. a multidisciplinary team and outreach services are important for the program, and community development is part of the process. in the usa, the copc concept has influenced health care planning for poor areas, especially provision of federally funded community health centers in attempts to provide health care for the underserved since the 1960s. in more recent years, copc has gained wider acceptance in the usa, where it is associated with family physician training and community health planning based on the risk approach and "managed care" systems. indeed, the three approaches are mutually complementary (box 2.9). as the emphasis on health care reform in the late 1990s moved towards managed care, the principles of copc were and will continue to be important in promoting health and primary prevention in all its modalities, as well as tertiary prevention with followup and maintenance of the health of the chronically ill. copc stresses that all aspects of health care have moved towards prevention based on measurable health issues in the community. through either formal or informal linkages between health services, the elements of copc are part of the daily work of health care providers and community services systems. the us institute of medicine issued the report on primary care in 1995, defining primary care as "the provision of integrated, accessible health care services by clinicians who are accountable for addressing the majority of personal health care needs, developing a sustained partnership with patients and practicing in the context of the family and the community". this formulation was criticized by the american public health association (apha) as lacking a public health perspective and failing to take into account both the individual and the community health approaches. copc tries to bridge this gap between the perspectives of primary care and public health. the community, whether local, regional, or national, is the site of action for many public health interventions. moreover, understanding the characteristics of the community is vital to a successful community-oriented approach. by the 1980s, new patterns of public health began to emerge, including all measures used to improve the health of the community, and at the same time working to protect and promote the health of the individual. the range of activities to achieve these general goals is very wide, including individual patient care systems and the community-wide activities that affect the health and well-being of the individual. these include the financing and management of health systems, evaluation of the health status of the population, and measures to improve the quality of health care. they place reliance on health promotion activities to change environmental risk factors for disease and death. they promote integrative and multisectoral approaches and the international health teamwork required for global progress in health. the definition of health in the charter of the who as a complete state of physical, mental, and social well-being had a ring of utopianism and irrelevance to states struggling to provide even minimal care in severely adverse political, economic, social, and environmental conditions (box 2.10). in 1977, a more modest goal was set for attainment of a level of health compatible with maximum feasible social and economic productivity. one needs to recognize that health and disease are on a dynamic continuum that affects everyone. the mission for public health is to use a wide range of methods to prevent disease and premature death, and improve quality of life for the benefit of individuals and the community. the world health organization defines health as "a state of complete physical, mental and social well-being, not merely the absence of disease or infirmity" (who constitution, 1948) . in 1978 at the alma-ata conference on primary health care, the who related health to "social and economic productivity in setting as a target the attainment by all the people of the world of a level of health that will permit them to lead a socially and economically productive life". three general programs of work for the periods 1984-1989, 1990-1995, and 1996-2001 were formulated as the basis of national and international activity to promote health. in 1995, the who, recognizing changing world conditions of demography, epidemiology, environment, and political and economic status, addressed the unmet needs of developing countries and health management needs in the industrialized countries, calling for international commitment to "attain targets that will make significant progress towards improving equity and ensuring sustainable health development". the 1999 object of the who is restated as "the attainment by all peoples of the highest possible level of health" as defined in the who constitution, by a wide range of functions in promoting technical cooperation, assisting governments, and providing technical assistance, international cooperation, and standards. in the 1960s, most industrialized countries were concentrating energies and financing in health care on providing access to medical and hospital services through national insurance schemes. developing countries were often spending scarce resources trying to emulate this trend. the who was concentrating on categorical programs, such as eradication of smallpox and malaria, as well as the expanded program of immunization and similar specific efforts. at the same time, there was a growing concern that developing countries were placing too much emphasis and expenditure on curative services and not enough on prevention and primary care. the world health assembly (wha) in 1977 endorsed the primary care approach under the banner of "health for all by the year 2000" (hfa 2000) . this was a landmark decision and has had important practical results. the who and the united nations children's fund (unicef) sponsored a seminal conference held in alma-ata, in the ussr ( kazakhstan), in 1978, which was convened to refocus health policy on primary care. the alma-ata declaration stated that health is a basic human right, and that governments are responsible to assure that right for their citizens and to develop appropriate strategies to fulfill this promise. this proposition has come to be increasingly accepted in the international community. the conference stressed the right and duty of people to participate in the planning and implementation of their health care. it advocated the use of scientifically, socially, and economically sound technology. joint action through intersectoral cooperation was also emphasized. the alma-ata declaration focused on primary health care as the appropriate method of assuming adequate access to health care for all (box 2.11). many countries have gradually come to accept the notion of placing priority on primary care, resisting the temptation to spend high percentages of health care resources on high-tech and costly medicine. spreading these same resources into highly costeffective primary care, such as immunization and nutrition programs, provides greater benefit to individuals and to society as a whole. alma-ata provided a new sense of direction for health policy, applicable to developing countries and in a different way than the approaches of the developed countries. during the 1980s, the health for all concept influenced national health policies in the developing countries with signs of progress in immunization coverage, for example, but the initiative was diluted as an unintended consequence by more categorical programs such as eradication of poliomyelitis. for example, developing countries have accepted immunization and diarrheal disease control as high-priority issues and achieved remarkable success in raising immunization coverage from some 10 percent to over 75 percent in just a decade. developed countries addressed these principles in different ways. in these countries, the concept of primary health care led directly to important conceptual developments in health. national health targets and guidelines are now common in many countries and are integral parts of box 2.11 declaration of alma-ata, 1978: a summary of primary health care (phc) 1. reaffirms that health is a state of complete physical, mental, and social well-being, and not merely the absence of disease or infirmity, and is a fundamental human right. existing gross inequalities in the health status of the people, particularly between developed and developing countries as well as within countries, are of common concern to all countries. 3. governments have a responsibility for the health of their people. the people have the right and duty to participate in planning and implementation of their health care. 4. a main social target is the attainment, by all peoples of the world by the year 2000, of a level of health that will permit them to lead a socially and economically productive life. 5. phc is essential health care based on practical, scientifically sound, and socially acceptable methods and technology. 6. it is the first level of contact of individuals, the family, and the national health system bringing health care as close as possible to where people live and work, as the first element of a continuing health care process. 7. phc evolves from the conditions and characteristics of the country and its communities, based on the application of social, biomedical, and health services research and public health experience. 8. phc addresses the main health problems in the community, providing promotive, preventive, curative, and rehabilitative services accordingly. 9. phc includes the following: (a) education concerning prevailing health problems and methods of preventing and controlling them (b) promotion of food supply and proper nutrition (c) adequate supply of safe water and basic sanitation (d) maternal and child health care, including family planning (e) immunization against the major infectious diseases (f) prevention of locally endemic diseases (g) appropriate treatment of common diseases and injuries (h) the provision of essential drugs (i) relies on all health workers … to work as a health team. 10. all governments should formulate national health policies, strategies and plans, mobilize political will and resources, used rationally, to ensure phc for all people. national health planning. reforms of the nhs -for example, as discussed in chapter 13, remuneration increases for family physicians and encouraging group practice with public health nursing support -have become widespread in the uk. leading health maintenance organizations, such as kaiser permanente in the usa and district health systems in canada, have emphasized integrated approaches to health care for registered or geographically defined populations (see chapters 11-13). this approach is becoming common in the usa in acos, which will be fostered by the 2010 obamacare legislation (ppaca). this systematic approach to individual and community health is an integral part of the new public health. the interactions among community public health, personal health services, and health-related behavior, including their management, are the essence of the new public health. how the health system is organized and managed affects the health of the individual and the population, as does the quality of providers. health information systems with epidemiological, economic, and sociodemographic analysis are vital to monitor health status and allow for changing priorities and management. well-qualified personnel are essential to provide services, manage the system, and carry out relevant research and health policy analysis. diffusion of data, health information, and responsibility helps to provide a responsive and comprehensive approach to meet the health needs of the individual and community. the physical, social, economic, and political environments are all important determinants of the health status of the population and the individual. joint action (intersectoral cooperation) between public and non-governmental or community-based organizations is needed to achieve the well-being of the individual in a healthy society. in the 1980s and 1990s, these ideas contributed to an evolving new public health, spurred on by epidemiological changes, health economics, the development of managed care linking health systems, and prepayment. knowledge and self-care skills, as well as community action to reduce health risks, are no less important in this than the roles of medical practitioners and institutional care. all are parts of a coherent holistic approach to health. the concept of selective primary care, articulated in 1979 by walsh and warren, addresses the needs of developing countries to select those interventions on a broad scale that would have the greatest positive impact on health, taking into account limited resources such as money, facilities, and human resources. the term selective primary care is meant to define national priorities that are based not on the greatest causes of morbidity or mortality, but on common conditions of epidemiological importance for which there are effective and simple preventive measures. throughout health planning, there is an implicit or explicit selection of priorities for allocation of resources. even in primary care, selection of targets is a part of the process of resource allocation. in modern public health, this process is more explicit. a country with limited resources and a high birth rate will emphasize maternal and child health before investing in geriatric care. this concept has become part of the microeconomics of health care and technology assessment, discussed in chapters 11 and 15, respectively, and is used widely in setting priorities and resource allocation. in developing countries, cost-effective primary care interventions have been articulated by many international organizations, including iodization of salt, use of oral rehydration therapy (ort) for diarrheal diseases, vitamin a supplementation for all children, expanded programs of immunization, and others that have the potential for saving hundreds of thousands of lives yearly at low cost. in developed countries, health promotions targeted to reduce accidents and risk factors such as smoking, high-fat diets, and lack of exercise for cardiovascular diseases are low-cost public health interventions that save lives and reduce the use of hospital care. targeting specific diseases is essential for efforts to control tb or eradicate polio, but at the same time, development of a comprehensive primary care infrastructure is equally or even more important than the single-disease approach. some disease entities such as hiv/aids attract donor funding more readily than basic infrastructure services such as immunization, and this can sometimes be detrimental to addressing the overall health needs of the population and other neglected but also important diseases. the risk approach selects population groups on the basis of risk and helps to determine interventional priorities to reduce morbidity and mortality. the measure of health risk is taken as a proxy for need, so that the risk approach provides something for all, but more for those in need, in proportion to that need. in epidemiological terms, these are people with higher relative risk or attributed risk. some groups in the general population are at higher risk than others for specific conditions. the expanded programme on immunization (epi), control of diarrhoeal diseases (cdd), and acute respiratory disease (ard) programs of the who are risk approaches to tackling fundamental public health problems of children in developing countries. public health places considerable emphasis on maternal and child health because these are vulnerable periods in life for specific health problems. pregnancy care is based on a basic level of care for all, with continuous assessment of risk factors that require a higher intensity of follow-up. prenatal care helps to identify factors that increase the risk for the pregnant woman or her fetus/newborn. efforts directed towards these special risk groups have the potential to reduce morbidity and mortality. high-risk case identification, assessment, and management are vital to a successful maternal care program. similarly, routine infant care is designed not only to promote the health of infants, but also to find the earliest possible indications of deviation and the need for further assessment and intervention to prevent a worsening of the condition. low birth-weight babies are at greater risk for many short-and long-term hazards and should be given special treatment. all babies are routinely screened for birth defects or congenital conditions such as hypothyroidism, phenylketonuria, and other metabolic and hematological diseases. screening must be followed by investigating and treating those found to have a clinical deficiency. this is an important element of infant care because infancy itself is a risk factor. as will be discussed in chapters 6 and 7 and others, epidemiology has come to focus on the risk approach with screening based on known genetic, social, nutritional, environmental, occupational, behavioral, or other factors contributing to the risk for disease. the risk approach has the advantage of specificity and is often used to initiate new programs directed at special categories of need. this approach can lead to narrow and somewhat rigid programs that may be difficult to integrate into a more general or comprehensive approach, but until universal programs can be achieved, selective targeted approaches are justifiable. indeed, even with universal health coverage, it is still important to address the health needs or issues of groups at special risk. working to achieve defined targets means making difficult choices. the supply and utilization of some services will limit availability for other services. there is an interaction, sometimes positive, sometimes negative, between competing needs and the health status of a population. public health identifies needs by measuring and comparing the incidence or prevalence of the condition in a defined population with that in other comparable population groups and defines targets to reduce or eliminate the risk of disease. it determines ways of intervening in the natural epidemiology of the disease, and develops a program to reduce or even eliminate the disease. it also assesses the outcomes in terms of reduced morbidity and mortality, as well as the economic justification in cost-effectiveness analysis to establish its value in health priorities. because of the interdependence of health services, as well as the total financial burden of health care, it is essential to look at the costs of providing health care, and how resources should be allocated to achieve the best results possible. health economics has become a fundamental methodology in policy determination. the costs of health care, the supply of services, the needs for health care or other health-promoting interventions, and effective means of using resources to meet goals are fundamental in the new public health. it is possible to err widely in health planning if one set of factors is overemphasized or underemphasized. excessive supply of one service diminishes the availability of resources for other needed investments in health. if diseases are not prevented or their sequelae not well managed, patients must use costly health care services and are unable to perform their normal social functions such as learning at school or performing at work. lack of investment in health promotion and primary prevention creates a larger reliance on institutional care, driving health costs upwards, and restricting flexibility in meeting patients' needs. the interaction of supply and demand for health services is an important determinant of the political economy of health care. health and its place in national priorities are determined by the social-political philosophy and resource allocation of a government. the case for action, or the justification for a public health intervention, is a complex of epidemiological, economic, and public policy factors (table 2 .1). each disease or group of diseases requires its own case for action. the justification for public health intervention requires sufficient evidence of the incidence and prevalence of the disease (see chapter 3). evidence-based public health takes into account the effectiveness and safety of an intervention; risk factors; safe means at hand to intervene; the human, social, and economic cost of the disease; political factors; and a policy decision as to the priority of the problem. this often depends on subjective factors, such as the guiding philosophy of the health system and the way it allocates resources. some interventions are so well established that no new justification is required to make the case, and the only question is how to do it most effectively. for example, infant vaccination is a cost-effective and cost-beneficial program for the protection of the individual child and the population as a whole. whether provided as a public service or as a clinical preventive measure by a private medical practitioner, it is in the interest of public health that all children be immunized. an outbreak of diarrheal disease in a kindergarten presents an obvious case for action, and a public health system must respond on an emergency basis, with selection of the most suitable mode of intervention. the considerations in developing a case for action are outlined above. need is based on clinical and epidemiological evidence, but also on the importance of an intervention in the eyes of the public. the technology available, its effectiveness and safety, and accumulated experience are important in the equation, as are the acceptability and affordability of appropriate interventions. the precedents for use of an intervention are also important. on epidemiological evidence, if the preventive practice has been seen to provide reduction in risk for the individual and for the population, then there is good reason to implement it. the costs, risks and benefits must be examined as part of the justification to help in the selection of health priorities. health systems research examines the efficiency of health care and promotes improved efficiency and effective use of resources. this is a vital function in determining how best to use resources and meet current health needs. past emphasis on hospital care at the expense of less development of primary care and prevention is still a common issue, particularly in former soviet and developing countries, where a high percentage of total health expenditure goes to acute hospital care with long length of stay, with smaller allocation to preventive and community health care. the result of this imbalance is high mortality from preventable diseases. new drugs, vaccines, and medical equipment are continually becoming available, and each new addition needs to be examined among the national health priorities. sometimes, owing to cost, a country cannot afford to add a new vaccine to the routine. however, when there is good evidence for efficacy and safety of new vaccines, drugs, diagnostic methods or other innovations, it could be applied for those at greatest risk. although there are ethical issues involved, it may be necessary to advise parents or family members to purchase the vaccine independently. clearly, recommending individual purchase of a vaccine is counter to the principle of equity and solidarity, benefiting middleclass families, and providing a poor basis of data for evaluation of the vaccine and its target disease. on the other hand, failure to advise parents of potential benefits to their children creates other ethical problems, but may increase public pressure and insurance system acceptance of new methods, e.g., varicella and hpv vaccines. mass screening programs involving complete physical examinations have not been found to be cost-effective or to significantly reduce disease. in the 1950s and 1960s, routine general health examinations were promoted as an effective method of finding disease early. since the late 1970s, a selective and specific approach to screening has become widely accepted. this involves defining risk categories for specific diseases and bearing in mind the potential for remedial action. early case finding of colon cancer by routine fecal blood testing and colonoscopy has been found to be effective, and pap smear testing to discover cancer of the cervix is timed according to risk category. screening for colorectal cancer is essential for modern health programs and has been adopted by most industrialized countries. outreach programs by visits, telephones, emails or other modern methods of communication are important to contact non-attenders to promote utilization, and have been shown to increase compliance with proven effective measures. these programs are important for screening, follow-up, and maintenance of treatment for hypertension, diabetes, and other conditions requiring long-term management. screening technology is changing and often the subject of intense debate as such programs are costly and their cost-effectiveness is an important matter for policy making: screening for lung cancer is becoming a feasible and effective matter for high-risk groups, whereas breast cancer screening frequency is now in dispute; while nanotechnology and bioengineering promises new methods for cancer screening. the factor of contribution to quality of life should be considered. a vaccine for varicella is justified partly for the prevention of deaths or illness from chickenpox. a stronger the right to health public expectation and social norms argument is often based on the fact that this is a disease that causes moderate illness in children for up to 2 weeks and may require parents to stay home with the child, resulting in economic loss to the parent and society. the fact that this vaccination prevents the occurrence of herpes zoster or shingles later in life may also be a justification. widespread adoption of hepatitis b vaccine is justified on the grounds that it prevents cancer of the liver, liver cirrhosis, and hepatic failure in a high percentage of the population affected. how many cases of a disease are enough to justify an intervention? one or several cases of some diseases, such as poliomyelitis, may be considered an epidemic in that each case constitutes or is an indicator of a wider threat. a single case of polio suggests that another 1000 persons are infected but have not developed a recognized clinical condition. such a case constitutes a public health emergency, and forceful organization to meet a crisis is needed. current standards are such that even one case of measles imported into a population free of the disease may cause a large outbreak, as occurred in the uk, france, and israel during 2007 through 2013, by contacts on an aircraft, at family gatherings, or even in medical settings. a measles epidemic indicates a failure of public health policy and practice. screening for some cancers, such as cervix and colon, is cost effective. screening of all newborns for congenital disorders is important because each case discovered early and treated effectively saves a lifetime of care for serious disability. assessing a public health intervention to prevent the disease or reduce its impact requires measurement of the disease in the population and its economic impact. there is no simple formula to justify a particular intervention, but the cost-benefit approach is now commonly required to make such a case for action. sometimes public opinion and political leadership may oppose the views of the professional community, or may impose limitations of policy or funds that prevent its implementation. conversely, professional groups may press for additional resources that compete for limited resources available to provide other needed health activities. both the professionals of the health system and the general public need full access to health-related information to take part in such debates in a constructive way. to maintain progress, a system must examine new technologies and justify their adoption or rejection (see chapter 15). the association between health and political issues was emphasized by european innovators such as rudolf virchow (and in great britain by edwin chadwick; see chapter 1) in the mid-nineteenth century, when the conditions of the working population were such that epidemic diseases were rife and mortality was high, especially in the crowded slums of the industrial revolution. the same observations led bismarck in germany to introduce early forms of social insurance for the health of workers and their families in the 1880s, and to britain's 1911 national health insurance, also for workers and families. the role of government in providing universal access to health care was a struggle in individual countries during the twentieth century and lasting into the second decade of the twenty-first century (e.g. president obama's affordable health care act of 2010). as the concept of public health has evolved, and the cost effectiveness of medical care has improved through scientific and technological advances, societies have identified health as a legitimate area of activity for collective bargaining and government. with this process, the need to manage health care resources has become more clearly defined as a public responsibility. in industrialized countries, each with very different political make-up, national responsibility for universal access to health has become part of the social ethos. with that, the financing and managing of health services have developed into part of a broad concept of public health, and economics, planning, and management have come to be part of the new public health (discussed in chapters 10-13). social, ethical, and political philosophies have profound effects on policy decisions including allocation of public monies and resources. investment in public health is now recognized as an integral part of socioeconomic development. governments are major suppliers of funds and leadership in health infrastructure development, provision of health services, and health payment systems. they also play a central role in the development of health promotion and regulation of the environment, food, and drugs essential for community health. in liberal social democracies, the individual is deemed to have a right to health care. the state accepts responsibility to ensure availability, accessibility, and quality of care. in many developed countries, government has also taken responsibility to arrange funding and services that are equitably accessible and of high quality. health care financing may involve taxation, allocation, or special mandatory requirements on employers to pay for health insurance. services may be provided by a state-financed and -regulated service or through ngos and/or private service mechanisms. these systems allocate between 6 percent and 14 percent of gross national product (gnp) to health services, with some governments funding over 80 percent of health expenditure; for example, canada and the uk. in communist states, the state organizes all aspects of health care with the philosophy that every citizen is entitled to equity in access to health services. the state health system manages research, staff training, and service delivery, even if operational aspects are decentralized to local health authorities. this model applied primarily to the soviet model of health services. these systems, except for cuba, placed financing of health low on the national priority, with funding less than 4 percent of gnp. in the shift to market economies in the 1990s, some former socialist countries, such as russia, are struggling with poor health status and a difficult shift from a strongly centralized health system to a decentralized system with diffusion of powers and responsibilities. promotion of market concepts in former soviet countries has reduced access to care and created a serious dilemma for their governments. former colonial countries, independent since the 1950s and 1960s, largely carried on the governmental health structures established in the colonial times. most developing countries have given health a relatively low place in budgetary allotment, with expenditures under 3 percent of gnp. since the 1980s, there has been a trend in developing countries towards decentralization of health services and greater roles for ngos, and the development of health insurance. some countries, influenced by medical concepts of their former colonial master countries, fostered the development of specialty medicine in the major centers with little emphasis on the rural majority population. soviet influence in many ex-colonial countries promoted state-operated systems. the who promoted primary care, but the allocations favored city-based specialty care. israel, as an ex-colony, adapted british ideas of public health together with central european sick funds and maternal and child health as major streams of development until the mid-1990s. a growing new conservatism in the 1980s and 1990s in the industrialized countries is a restatement of old values in which market economics and individualistic social values are placed above concepts of the "common good" of liberalism and socialism in its various forms. in the more extreme forms of this concept, the individual is responsible for his or her own health, including payment, and has a choice of health care providers that will respond with high-quality personalized care. market forces, meaning competition in financing and provision of health services with rationing of services, based on fees or private insurance and willingness and ability to pay, have become part of the ideology of the new conservatism. it is assumed that the patient (i.e., the consumer) will select the best service for his or her need, while the provider best able to meet consumer expectations will thrive. in its purest form, the state has no role in providing or financing of health services except those directly related to community protection and promotion of a healthful environment without interfering with individual choices. the state ensures that there are sufficient health care providers and allows market forces to determine the prices and distribution of services with minimal regulation. the usa retains this orientation in a highly modified form, with 86 percent of the population covered by some form of private or public insurance systems (see chapters 10 and 13). modified market forces in health care are part of health reforms in many countries as they seek not only to ensure quality health care for all but also to constrain costs. a free market in health care is costly and ultimately inefficient because it encourages inflation of provider incomes or budgets and increasing utilization of highly technical services. further, even in the most free market societies, the economy of health care is highly influenced by many factors outside the control of the consumer and provider. the total national health expenditure in the usa rose rapidly until reaching over 17.7 percent of gross domestic product (gdp) in 2011, the highest of any country, despite serious deficiencies for those without any or with very inadequate health insurance (in total more than 30 percent of the population). this figure compares to some 11.2 percent of gdp in canada, which has universal health insurance under public administration. following the 1994 defeat of president clinton's national health program, the conservative congress and the business community took steps to expand managed care in order to control costs, resulting in a revolution in health care in the usa (see chapters 11 and 13). in the 2011-2019 decade health expenditure in the usa is expected to rise to 19.6 percent of gdp, partly owing to increased population coverage with implementation of the ppaca (obamacare). reforms are being implemented in many "socialized" health systems. these may be through incentives to promote achievement of performance indicators, such as full immunization coverage. others are using control of supply, such as hospital beds or licensed physicians, as methods of reducing overutilization of services that generates increasing costs. market mechanisms in health are aimed not only at the individual but also at the provider. incentive payment systems must work to protect the patient's legitimate needs, and conversely incentives that might reduce quality of care should be avoided. fee-for-service promotes high rates of services such as surgery. increasing private practice and user fees can adversely affect middle-and low-income groups, as well as employers, by raising the costs of health insurance. managed care systems, with restraints on fee-for-service medical practice, have emerged as a positive response to the market approach. incentive systems in payments for services may be altered by government or insurance agencies in order to promote rational use of services, such as reduction of hospital stays. the free market approach is affecting planning of health insurance systems in previously highly centralized health systems in developing countries as well as the redevelopment of health systems in former soviet countries. despite political differences, reform of health systems has become a common factor in virtually all health systems since the 1990s, as each government searches for costeffectiveness, quality of care, and universality of coverage. the new paradigm of health care reform sees the convergence of different systems to common principles. national responsibility for health goals and health promotion leads to national financing of health care with regional and managed care systems. most developed countries have long since adopted national health insurance or service systems. some governments may, as in the usa, insure only the highest risk groups such as the elderly and the poor, leaving the working and middle classes to seek private insurers. the nature and direction of health care reform affecting coverage of the population are of central importance in the new public health because of its effects on allocation of resources and on the health of the population. the effects of the economic crisis in the usa are being felt worldwide. while the downturn has largely occurred in wealthier nations, the poor in low-income countries will be among those affected. past economic downturns have been followed by substantial drops in foreign aid to developing countries. as public health gained from sanitary and other control measures for infectious diseases, along with mother and child care, nutrition, and environmental and occupational health, it also gained strength and applicability from advances in the social and behavioral sciences. social darwinism, a political philosophy that assumed "survival of the fittest" and no intervention of the sate to alleviate this assumption, was popular in the early nineteenth century but became unacceptable in industrialized countries, which adopted social policies to alleviate the worst conditions of poverty, unemployment, poor education, and other societal ills. the political approach to focusing on health and poverty is associated with jeremy bentham in britain in the late eighteenth century, who promoted social and political reform and "the greatest good for the greatest number", or utilitarianism. rudolf virchow, an eminent pathologist and a leader in recognizing ill-health and poverty as cause and effect, called for political action to create better conditions for the poor and working-class population. the struggle for a social contract was promoted by pioneer reformists such as edwin chadwick (general report on the sanitary condition of the labouring population of great britain, 1842), who later became the first head of the board of health in britain, and lemuel shattuck (report of a general plan for the promotion of public and personal health, 1850) . shattuck was the organizer and first president of the american statistical association. the social sciences have become fundamental to public health, with a range of disciplines including vital statistics and demography (seventeenth century), economics and politics (nineteenth century), sociology (twentieth century), history, anthropology, and others, which provide collectively important elements of epidemiology of crucial significance for survey methods and qualitative research (see chapter 3). these advances contributed greatly to the development of methods of studying diseases and risk factors in a population and are still highly relevant to addressing inequalities in health. individuals in good health are better able to study and learn, and be more productive in their work. improvements in the standard of living have long been known to contribute to improved public health; however, the converse has not always been recognized. investment in health care was not considered a high priority in many countries where economic considerations directed investment to the "productive" sectors such as manufacturing and large-scale infrastructure projects, such as hydroelectric dams. whether health is a contributor to economic development or a drain on societies' resources has been a fundamental debate between socially and market-oriented advocates. classic economic theory, both free enterprise and communist, has tended to regard health as a drain on economies, distracting investment needed for economic growth. as a result, in many countries health has been given low priority in budgetary allocation, even when the major source of financing is governmental. this belief among economists and banking institutions prevented loans for health development on the grounds that such funds should focus on creating jobs and better incomes, before investing in health infrastructure. consequently, the development of health care has been hampered. a socially oriented approach sees investment in health as necessary for the protection and development of "human capital", just as investment in education is needed for the long-term benefit of the economy of a country. in 1993, the world bank's world development report: investing in health articulated a new approach to economics in which health, along with education and social development, is seen as an essential precondition for and contributor to economic development. while many in the health field have long recognized the importance of health for social and economic improvement, its adoption by leading international development banking may mark a turning point for investment in developing nations, so that health may be a contender for increased development loans. the concept of an essential package of services discussed in that report establishes priorities in low-and middle-income countries for efficient use of resources based on the burden of disease and cost-effectiveness analysis of services. it includes both preventive and curative services targeted to specific health problems. it also recommends support for comprehensive primary care, such as for children, and infrastructure development including maternity and hospital care, medical and nursing outreach services, and community action to improve sanitation and safe water supplies. reorientation of government spending on health is increasingly being adopted, as in the uk, to improve equity in access for the poor and other neglected sectors or regions of society with added funding for relatively deprived areas to improve primary care services. differential capitation funding as a form of affirmative action to provide for highneeds populations is a useful concept in public health terms to address the inequities still prevalent in many countries. as medical care has gradually become more involved in prevention, and as it has moved into the era of managed care, the gap between public health and clinical medicine has narrowed. as noted above, many countries are engaged in reforms in their health care systems. the motivation is largely derived from the need for cost containment, but also to extend health care coverage to underserved parts of the population. countries without universal health care still have serious inequities in distribution of or access to services, and may seek reform to reduce those inequities, perhaps under political pressures to improve the provision of services. incentives for reform are needed to address regional inequities, and preserving or developing universal access and quality of care, but also on inequities in health between the rich and the poor countries and within even the wealthy countries. in some settings, a health system may fail to keep pace with developments in prevention and in clinical medicine. some countries have overdeveloped medical and hospital care, neglecting important initiatives to reduce the risk of disease. the process of reform requires setting standards to measure health status and the balance of services to optimize health. a health service can set a target of immunizing 95 percent of infants with a national immunization schedule, but requires a system to monitor performance and incentives for changes. a health system may also have failed to adapt to changing needs of the population through lack, or misuse, of health information and monitoring systems. as a result, the system may err seriously in its allocation of resources, with excessive emphasis on hospital care and insufficient attention to primary and preventive care. all health services should have mechanisms for correctly gathering and analyzing needed data for monitoring the incidence of disease and other health indicators, such as hospital utilization, ambulatory care, and preventive care patterns. for example, the uk's nhs periodically undertakes a restructuring process of parts of the system to improve the efficiency of service. this involves organizational changes and decentralization with regional allocation of resources (see chapter 13). health systems are under pressures of changing demographic and epidemiological patterns as well as public expectations, rising costs of new technology, financing, and organizational change. new problems must be continually addressed with selection of priority issues and the most effective methods chosen. reforms may create unanticipated problems, such as professional or public dissatisfaction, which must be evaluated, monitored, and addressed as part of the evolution of public health. literacy, freedom of the press, and increasing public concern for social and health issues have contributed to the development of public health. the british medical community lobbied for restrictions on the sale of gin in the 1780s in order to reduce the damage that it caused to the working class. in the late eighteenth and the nineteenth centuries, reforms in society and sanitation were largely the result of strongly organized advocacy groups influencing public opinion through the press. such pressure stimulated governments to act in regulating the working conditions of mines and factories. abolition of the slave trade and its suppression by the british navy in the early nineteenth century resulted from successful advocacy groups and their effects on public opinion through the press. vaccination against smallpox was promoted by privately organized citizen groups, until later taken up by local and national government authorities. advocacy consists of activities of individuals or groups publicly pleading for, supporting, espousing, or recommending a cause or course of action. the advocacy role of reform movements in the nineteenth century was the basis of the development of modern organized public health. campaigns ranged from the reform of mental hospitals, nutrition for sailors to prevent scurvy and beriberi, and labor laws to improve working conditions for women and children in particular, to the promotion of universal education and improved living conditions for the working population. reforms on these and other issues resulted from the stirring of the public consciousness by advocacy groups and the public media, all of which generated political decisions in parliaments (box 2.12). such reforms were in large part motivated by fear of revolution throughout europe in the mid-nineteenth century and the early part of the twentieth century. trade unions, and before them medieval guilds, fought to improve hours, safety, and conditions of work, as well as social and health benefits for their members. in the usa, collective bargaining through trade unions achieved wage increases and widespread coverage of the working population under voluntary health insurance. unions and some industries pioneered prepaid group practice, the predecessor of health maintenance organizations and managed care or the more recent acos (see chapters 10 and 13). through raising public consciousness on many issues, advocacy groups pressure governments to enact legislation to restrict smoking in public places, prohibit tobacco advertising, and mandate the use of bicycle helmets. advocacy groups play an important role in advancing health based on disease groups, such as cancer, multiple sclerosis, and thalassemia, or advancing health issues, such as the organizations promoting breastfeeding, environmental improvement, or smoking reduction. some organizations finance services or facilities not usually provided within insured health programs. such organizations, which can number in the hundreds in a country, advocate the importance of their special concern and play an important role in innovation and meeting community health needs. advocacy groups, including trade unions, professional groups, women's groups, self-help groups, and many others, focus on specific issues and have made major contributions to advancing the new public health. the history of public health is replete with pioneers whose discoveries led to strong opposition and sometimes violent rejection by conservative elements and vested interests in medical, public, or political circles. opposition to jennerian vaccination, the rejection of semmelweiss by colleagues in vienna, and the contemporary opposition to the work of great pioneers in public health such as pasteur, florence nightingale, and many others may deter or delay implementation of other innovators and new breakthroughs in preventing disease. although opposition to jenner's vaccination lasted well into the late nineteenth century in some areas, its supporters gradually gained ascendancy, ultimately leading to the global eradication of smallpox. these and other pioneers led the way to improved health, often after bitter controversy on topics later accepted and which, in retrospect, seem to be obvious. advocacy has sometimes had the support of the medical profession but elicited a slow response from public authorities. david marine of the cleveland clinic and david cowie, professor of pediatrics at the university of michigan, proposed the prevention of goiter by iodization of salt. marine carried out a series of studies in fish, and then in a controlled clinical trial among schoolgirls in 1917-1919, with startlingly positive results in reducing the prevalence of goiter. cowie campaigned for the iodization of salt, with support from the medical profession. in 1924, he convinced a private manufacturer to produce morton's iodized salt, which rapidly became popular throughout north america. similarly, iodized salt came to be used in many parts of europe, mostly without governmental support or legislation. iodine-deficiency disorders (idds) remain a widespread condition, estimated to have affected 2 billion people worldwide in 2013. the target of international eradication of idds by 2000 was set at the world summit for children in 1990, and the who called for universal iodization of salt in 1994. by 2008, nearly 70 percent of households in developing countries consumed adequately iodized salt. china and nigeria, have had great success in recent years with mandatory salt fortification in increasing iodization rates, in china from 39 percent to 95 percent in 10 years. but the problem is not yet gone and even in europe there is inadequate standardization of iodine levels and population follow-up despite decades of work on the problem. professional organizations have contributed to promoting causes such as children's and women's health, and environmental and occupational health. the american academy of pediatrics has contributed to establishing and promoting high standards of care for infants and children in the usa, and to child health internationally. hospital accreditation has been used for decades in the usa, canada, and more recently in australia and the uk. it has helped to raise standards of health facilities and care by carrying out systematic peer review of hospitals, nursing homes, primary care facilities, and mental hospitals, as well as ambulatory care centers and public health agencies (see chapter 15). public health needs to be aware of negative advocacy, sometimes based on professional conservatism or economic self-interest. professional organizations can also serve as advocates of the status quo in the face of change. opposition by the american medical association (ama) and the health insurance industry to national health insurance in the usa has been strong and successful for many decades. the passage of the ppaca has been achieved despite widespread political and public opposition, yet was sustained in the us supreme court and is gaining widening popular support as the added value to millions of formerly uninsured americans becomes clear. in some cases, the vested interest of one profession may block the legitimate development of others, such as when ophthalmologists lobbied successfully against the development of optometry, now widely accepted as a legitimate profession. political activism for reform in nineteenth-century britain led to banning and suppressing the slave trade, improvements in working conditions for miners and factory workers, and other major political reforms. in keeping with this tradition, samuel plimsoll (1824-1898), british member of parliament elected for derby in 1868, conducted a solo campaign for the safety of seamen. his book, our seamen, described ships sent to sea so heavily laden with coal and iron that their decks were awash. seriously overloaded ships, deliberately sent to sea by unscrupulous owners, frequently capsized, drowning many crew members, with the owners collecting inflated insurance fees. overloading was the major cause of wrecks and thousands of deaths in the british shipping industry. plimsoll pleaded for mandatory load-line certificate markers to be issued to each ship to prevent any ships putting to sea when the marker was not clearly visible. powerful shipping interests fought him every inch of the way, but he succeeded in having a royal commission established, leading to an act of parliament mandating the "plimsoll line", the safe carrying capacity of cargo ships. this regulation was adopted by the us bureau of shipping as the load line act in 1929 and is now standard practice worldwide. jenner's discovery of vaccination with cowpox to prevent smallpox was adopted rapidly and widely. however, intense opposition by organized groups of antivaccinationists, often led by those opposed to government intervention in health issues and supported by doctors with lucrative variolation practices, delayed the implementation of smallpox vaccination for many decades. ultimately, smallpox was eradicated in 1972, owing to a global campaign initiated by the who. opposition to legislated restrictions on private ownership of assault weapons and handguns is intense in the usa, led by well-organized, well-funded, and politically powerful lobby groups, despite the amount of morbidity and mortality due to gun-associated violent acts (see chapter 5). fluoridation of drinking water is the most effective public health measure for preventing dental caries, but it is still widely opposed, and in some places the legislation has been rescinded even after implementation, by wellorganized antifluoridation campaigns. opposition to fluoridation of community water supplies is widespread, and effective lobbying internationally has slowed but has not stopped progress (see chapter 6). despite the life-saving value of immunization, opposition still exists in 2013 and harms public health protection. opposition has slowed progress in poliomyelitis eradication; for example, radical islamists killed polio workers in northern nigeria in 2012, one of the last three countries with endemic poliomyelitis. resistance to immunization in the 1980s has resulted in the recurrence of pertussis and diphtheria and a very large epidemic of measles across western europe, including the uk, with further spread to the western hemisphere in 2010-2013 (see chapter 4). progress may be blocked where all decisions are made in closed discussions, not subject to open scrutiny and debate. public health personnel working in the civil service of organized systems of government may not be at liberty to promote public health causes. however, professional organizations may then serve as forums for the essential professional and public debate needed for progress in the field. professional organizations such as the apha provide effective lobbying for the interests of public health programs and can have an important impact on public policy. in mid-1996, efforts by the secretary of health and human services in the usa brought together leaders of public health with representatives of the ama and academic medical centers to try to find areas of common interest and willingness to promote the health of the population. in europe too, increasing cooperation between public health organizations is stimulating debate on issues of transnational importance across the region, which, for example, has a wide diversity of standards on immunization practices and food policies. public advocacy has played an especially important role in focusing attention on ecological issues (box 2.13). in 1995, greenpeace, an international environmental activist group, fought to prevent the dumping of an oil rig in the north sea and forced a major oil company to find another solution that would be less damaging to the environment. an explosion on an oil rig in the gulf of mexico in 2010 led to enormous ecological and economic damage as well as loss of life. damages levied on the responsible company (british petroleum) amount to some $4.5 billion dollars and several criminal negligence charges are pending. greenpeace also continued its efforts to stop the renewal of testing of atomic bombs by france in the south pacific. international protests led to the cessation of almost all testing of nuclear weapons. international concern over global warming has led to growing efforts to stem the tide of air pollution from fossil fuels, coal-burning electrical production, and other manifestations of carbon dioxide and toxic contamination of the environment. progress is far from certain as newly enriched countries such as china and india follow the rising consumption patterns of western countries. public advocacy and rejection of wanton destruction of the global ecology may be the only way to prod consumers, governments, and corporate entities such as the energy and transportation industries to change direction. the pace of change from fossil fuels is slow but has captured public attention, and private companies are seeking more fuel efficiency in vehicles and electrical power production, mainly though the use of natural gas instead of fuel oil and coal for electricity production or better still by wind and solar energy. the search for "green solutions" to the global warming crisis has become increasingly dynamic, with governments, the private sector, and the general public keenly aware of the importance of the effort and the dangers of failure. in the latter part of the twentieth century and the early twenty-first century, prominent international personalities and entertainers have taken up causes such as the removal of land mines in war-torn countries, illiteracy in disadvantaged advocacy is a function in public health that has been important in promoting advances in the field, and one that sometimes places the advocate in conflict with established patterns and organizations. one of the classic descriptions of this function is in henrik ibsen's play an enemy of the people, in which the hero, a young doctor, thomas stockmann, discovers that the water in his community is contaminated. this knowledge is suppressed by the town's leadership, led by his brother the mayor, because it would adversely affect plans to develop a tourist industry of baths in their small norwegian town in the late nineteenth century. the young doctor is taunted and abused by the townspeople and driven from the town, having been declared an "enemy of the people" and a potential risk. the allegory is a tribute to the man of principle who stands against the hysteria of the crowd. the term also took on a far more sinister and dangerous meaning in george orwell's novel 1984 and in totalitarian regimes of the 1930s to the present time. populations, and funding for antiretroviral drugs for african countries to reduce maternal-fetal transmission of hiv and to provide care for the large numbers of cases of aids devastating many countries of sub-saharan africa. rotary international has played a key role in polio eradication efforts globally. the public-private consortium global alliance for vaccines and immunization (gavi) has been instrumental in promoting immunization in recent years, with participation by the who, unicef, the world bank, the gates foundation, vaccine manufacturers, and others. this has had an important impact on extending immunization to protect and save the lives of millions of children in deprived countries not yet able to provide fundamental prevention programs such as immunization at adequate levels. gavi has brought vaccines to low-income countries around the world, such as rotavirus vaccine, pentavalent vaccine in myanmar, and pneumococcal vaccine for children in 15 countries in sub-saharan africa, including dr congo. the bill & melinda gates foundation pledged us $750 million in 1999 to establish gavi, with us $75 million per year and us $1 billion in 2010 to promote the decade of vaccines. international conferences help to create a worldwide climate of advocacy for health issues. international sanitary conferences in the nineteenth century were convened in response to the cholera epidemics. international conferences continue in the twenty-first century to serve as venues for advocacy on a global scale, bringing forward issues in public health that are beyond the scope of individual nations. the who, unicef, and other international organizations perform this role on a continuing basis (see chapter 16). criticisms of this approach have focused on the lack of similar effort or donors to address ncds, weak public health infrastructure, and that this frees national governments from responsibility to care for their own children. no one can question, however, that this kind of endeavor has saved countless lives and needs the backing of other aid donors and national government participation. consumerism is a movement that promotes the interests of the purchaser of goods or services. in the 1960s, a new form of consumer advocacy emerged from the civil rights and antiwar movement in the usa. concern was focused on the environment, occupational health, and the rights of the consumer. rachel carson stimulated concern by dramatizing the effects of ddt on wildlife and the environment but inadvertently jeopardized anti-malarial efforts in many countries. this period gave rise to environmental advocacy efforts worldwide, and a political movement, the greens, in western europe. ralph nader showed the power of the advocate or "whistle-blower" who publicizes health hazards to stimulate active public debate on a host of issues related to the public well-being. nader, a consumer advocate lawyer, developed a strategy for fighting against business and government activities and products which endangered public health and safety. his 1965 book unsafe at any speed took issue with the us automobile industry for emphasizing profit and style over safety, and led to the enactment of the national traffic and motor safety act of 1966, establishing safety standards for new cars. this was followed by a series of enactments including design and emission standards and seat-belt regulations. nader's work continues to promote consumer interests in a wide variety of fields, including the meat and poultry industries, and coal mining, and promotes greater government regulatory powers regarding pesticide usage, food additives, consumer protection laws, rights to knowledge of contents, and safety standards. consumerism has become an integral part of free market economies, and the educated consumer does influence the quality, content, and price of products. greater awareness of nutrition in health has influenced food manufacturers to improve packaging, content labeling, enrichment with vitamins and minerals, and advertisement to promote those values. low-fat dietary products are available because of an increasingly sophisticated public concerned over dietary factors in cardiovascular diseases. the same process occurred in safe toys and clothing for children, automobile safety features such as mandatory use of car seats for infants, and other innovations that quickly became industry standards in the industrialized world. dangerous practices such as the use of lead paint in toys and melamine contamination of milk products from china capture the public attention quickly and remind public health authorities of the importance of continuous alertness to potential hazards. consumerism can also be exploited by pharmaceutical companies with negative impacts on the health system, especially in the advertising of health products which leads to unnecessary visits to health providers and pressure for approval to obtain the product. the internet has provided people with access to a vast array of information and opinion, and to current literature otherwise unavailable because of the often inadequate library resources of medical and other health professionals. the very freedom of information the internet allows, however, also provides a vehicle for extremist and fringe groups to promote disinformation such as "vaccination causes autism, fluoridation causes cancer", which can cause considerable difficulties for basic public health programs or lead to self-diagnosis of conditions, with often disastrous consequences. advocacy and voluntarism go hand in hand. voluntarism takes many forms, including raising funds for the development of services or operating services needed in the community. it may take the form of fund-raising to build clinics or hospitals in the community, or to provide medical equipment for elderly or handicapped people; or retirees and teenagers working as hospital volunteers to provide services that are not available through paid staff, and to provide a sense of community caring for the sick in the best traditions of religious or municipal concerns. this can also be extended to prevention, as in support for immunization programs, assistance for the handicapped and elderly in transportation, meals-on-wheels, and many other services that may not be included in the "basket of services" provided by the state, health insurance, or public health services. community involvement can take many forms, and so can voluntarism. the pioneering role of women's organizations in promoting literacy, health services, and nutrition in north america during the latter part of the nineteenth and the early twentieth centuries profoundly affected the health of the population. the advocacy function is enhanced when an organization mobilizes voluntary activity and funds to promote changes or needed services, sometimes forcing official health agencies or insurance systems to revise their attitudes and programs to meet these needs. by the early 1970s, canada's system of federally supported provincial health insurance plans covered all of the country. the federal minister of health, marc lalonde, initiated a review of the national health situation, in view of concern over the rapidly increasing costs of health care. this led to articulation of the "health field concept" in 1974, which defined health as a result of four major factors: human biology, environment, behavior, and health care organization (box 2.14). lifestyle and environmental factors were seen as important contributors to the morbidity and mortality in modern societies. this concept gained wide acceptance, promoting new initiatives that emphasized health promotion in response to environmental and lifestyle factors. conversely, reliance primarily on medical care to solve all health problems could be counterproductive. this concept was a fundamental contributor to the idea of health promotion later articulated in the ottawa declaration, discussed below. the health field concept came at a time when many epidemiological studies were identifying risk factors for cardiovascular diseases and cancers that related to personal habits, such as diet, exercise, and smoking. the concept advocated that public policy needed to address individual lifestyle as part of the overall effort to improve health status. as a result, the canadian federal government established health promotion as a new activity. this quickly spread to many other jurisdictions and gained wide acceptance in many industrialized countries. concern was expressed that this concept could become a justification for a "blame the victim" approach, in which those ill with a disease related to personal lifestyles, such as smokers or aids patients, are seen as having chosen to contract the disease. such a patient might then be considered not to be entitled to all benefits of insurance or care that others may receive. the result may be a restrictive approach to care and treatment that would be unethical in the public health tradition and probably illegal in western jurisprudence. this concept was also used to justify withdrawal from federal commitments in cost sharing and escape from facing controversial health reform in the national health insurance program. during the 1960s and 1970s, outspoken critics of health care systems, such as ivan illytch, questioned the value of medical care for the health of the public. this became a widely discussed, somewhat nihilistic, view towards medical care, and was influential in promoting skepticism regarding the value of the biomedical mode of health care, and antagonism towards the medical profession. in 1976, thomas mckeown presented a historicalepidemiological analysis showing that up to the 1950s, medical care had only a limited impact on mortality rates, although improvements in surgery and obstetrics were notable. he showed that crude death rates in england averaged about 30 per 1000 population from 1541 to 1750, declining steeply to 22 per 1000 in 1851, 15 per 1000 in 1901, and 12 per 1000 in 1951, when medical care became truly effective. mckeown concluded that much of the improvement in health status over the past several centuries was due to reduced mortality from infectious diseases. this he related to limitation of family size, increased food supplies, improved nutrition and sanitation, specific preventive and therapeutic measures, and overall gains in quality of life for growing elements of the population. he cautioned against placing excessive reliance for health on medical care, much of which was of unproved effectiveness. this skepticism of the biomedical model of health care was part of wider antiestablishment feelings of the 1960s and 1970s in north america. in 1984, milton roemer pointed out that the advent of vaccines, antibiotics, antihypertensives, and other medications contributed to great improvements in infant and child care, and in the management of infectious diseases, hypertension, diabetes, and other conditions. therapeutic gains continue to arrive from teaching centers around the world. vaccine, pharmaceutical, and diagnostic equipment manufacturers continue to provide important innovations that have major benefits, but also raise the cost of health care. the latter issue is one which has stimulated the search for reforms, and search for lower cost technologies such as in treatment of hepatitis c patients, a huge international public health issue. the value of medical care to public health and vice versa has not always been clear, either to public health personnel or to clinicians. the achievements of modern public health in controlling infectious diseases, and even more so in reducing the mortality and morbidity associated with chronic diseases such as stroke and chd, were in reality a shared achievement between clinical medicine and public health (see chapter 5). preventive medicine has become part of all medical practice, with disease prevention through early diagnosis and health promotion through individual and community-focused activities. risk factor evaluation determines appropriate screening and individual and community-based interventions. medical care is crucial in controlling hypertension and in reducing the complications and mortality from chd. new modalities of treatment are reducing death rates from first time acute myocardial infarctions. better management of diabetes prevents the early onset of complications. at the same time, the contribution of public health to improving outcomes of medical care is equally important. control of the vaccine-preventable diseases, improved nutrition, and preparation for motherhood contribute to improved maternal and infant outcomes. promotions of reduced exposure to risk factors for chronic disease are a task shared by public health and clinical medical services. both clinical medicine and public health contribute to improved health status. they are interdependent and rely on funding systems for recognition as part of the new public health. during the 1950s, many new management concepts emerged in the business community, such as "management by objective", a concept developed by peter drucker at general motors, with variants such as "zero-based budgeting" developed in the us department of defense (see chapter 12). they focused the activities of an organization and its budget on targets, rather than on previous allocation of resources. these concepts were applied in other spheres, but they influenced thinking in health, whose professionals were seeking new ways to approach health planning. the logical application was to define health targets and to promote the efficient use of resources to achieve those targets. this occurred in the usa and soon afterwards in the who european region. in both cases, a wide-scale process of discussion and consensus building was used before reaching definitive targets. this process contributed to the adoption of the targets by many countries in europe as well as by states and many professional and consumer organizations. the usa developed national health objectives in 1979 for the year 1990 and subsequently for the year 2000, with monitoring of progress in their achievement and development of further targets for 2010 and now for 2020. beginning in 1987, state health profiles are prepared by the epidemiology program office of the centers for disease control and prevention based on 18 health indicators recommended by a consensus panel representing public health associations and organizations. the eight mdgs adopted by the un in 2000 include halving extreme poverty, reducing child mortality by twothirds, improving maternal health, halting the spread of hiv/aids, malaria, and other diseases, and providing universal primary education, all by the target date of 2015. the mdgs form a common blueprint agreed to by all countries and the world's leading development institutions. the process has galvanized unprecedented efforts to meet the needs of the world's poorest, yet 2008 reviews of progress indicate that most developing nations will not meet the targets at current rates of progress. the united nations development programme (undp) global partnership for development 2012 report on the mdgs states that if the national development strategies and initiatives are supported by international development partners, the goals can be achieved by 2015. the mdgs were adopted by over 120 nations and provided guidance for national policies and for international aid agencies. the focus was on middle-and low-income countries and their achievements have been considerable but variable (see box 2.15 and chapter 16) . as of july 2012, extreme poverty was falling in every region, the poverty reduction target had been met, the world had met the target of halving the proportion of people without access to improved sources of water, and the world had achieved parity in primary education between girls and boys. further progress will require sustained political commitment to develop the primary care infrastructure: improved reporting and epidemiological monitoring, consultative mechanisms, and consensus by international agencies, national governments, and non-governmental agencies. the achievement of the targets will also require sustained international support and national commitment with all the difficulties of a time of economic recession. nevertheless, defining a target is crucial to the process. there are encouraging signs that national governments are influenced by the general movement to place greater emphasis on resource allocation and planning on primary care to achieve internationally recognized goals and targets. the successful elimination of smallpox, rising immunization coverage in the developing countries, and increasing implementation of salt iodization have shown that such goals are achievable. while the usa has not succeeded in developing universal health care access, it has a strong tradition of public health and health advocacy. federal, state, and local health authorities have worked out cooperative arrangements for financing and supervising public health and other services. with growing recognition in the 1970s that medical services alone would not achieve better health results, health policy leadership in the federal government formulated a new approach, in the form of developing specific health targets for the nation. in 1979, the surgeon general of the usa published the report on health promotion and disease prevention (healthy people). this document set five overall health goals for each of the major age groups for the year 1990, accompanied by 226 specific health objectives. new targets for the year 2000 were developed in three broad areas: to increase healthy lifespans, to reduce health disparities, and to achieve access to preventive health care for all americans. these broad goals are supported by 297 specific targets in 22 health priority areas, each one divided into four major categories: health promotion, health protection, preventive services, and surveillance systems. this set the public health agenda on the basis of measurable indicators that can be assessed year by year. reduce child mortality -progress on child mortality is gaining momentum. the target is to reduce by two-thirds, between 1990 and 2015, the under-5-year-old mortality rate, from 93 children of every 1000 dying to 31 of every 1000. child deaths are falling, but much more needs to be done in order to reach the development goal. revitalizing efforts against pneumonia and diarrhea, while bolstering nutrition, could save millions of children. l mdg5. improve maternal health -maternal mortality has nearly halved since 1990, but levels are far removed from the 2015 target. the targets for improving maternal health include reducing by three-quarters the maternal mortality ratio and achieve universal access to reproductive health. poverty and lack of education perpetuate high adolescent birth rates. inadequate funding for family planning is a major failure in fulfilling commitments to improving women's reproductive health. l mdg6. combat hiv/aids, malaria, tuberculosis, and other diseases -more people than ever are living with hiv owing to fewer aids-related deaths and the continued large number of new infections. in 2011, an estimated 34.2 million were living with hiv, up 17 percent from 2001. this persistent increase reflects the continued large number of new infections along with a significant expansion of access to lifesaving antiretroviral therapy, especially in more recent years. l mdg7. ensure environmental sustainability -the unparalleled success of the montreal protocol shows that action on climate change is within grasp. the 25th anniversary of the montreal protocol on substances that deplete the ozone layer, in 2012, had many achievements to celebrate. most notably, there has been a reduction of over 98 percent in the consumption of ozone-depleting substances. further, because most of these substances are also potent greenhouse gases, the montreal protocol has contributed significantly to the protection of the global climate system. the reductions achieved to date leave hydrochlorofluorocarbons (hcfcs) as the largest group of substances remaining to be phased out. l mdg8. a global partnership for development -core development aid fell in real terms for the first time in more than a decade, as donor countries faced fiscal constraints. in 2011, net aid disbursements amounted to $133.5 billion, representing 0.31 percent of developed countries' combined national income. while constituting an increase in absolute dollars, this was a 2.7 percent drop in real terms over 2010. if debt relief and humanitarian aid are excluded, bilateral aid for development programmes and projects fell by 4.5 percent in real terms. equitable and sustainable funding of health services. 18. developing human resources (educational programs for providers and managers based on the principles of the health for all policy). 19. research and knowledge: health programs based on scientific evidence. 20. mobilizing partners for health (engaging the media/ television/internet). 21. policies and strategies for health for all -national, targeted policies based on health for all. a 2010-2012 review has been commissioned by the european office of the who to assess inequalities in the social determinants of health. while health has improved there are still significant inequalities. factors include variance in local, regional, national, and global economic forces. the european union and the european region of who are both working on health targets for the year 2020. there are competing demands in society for expenditure by the government, and therefore making the best use of resources -money and people -is an important objective. the uk has devolved many of the responsibilities to the constituent countries (england, wales, scotland, and northern ireland) within an overall national framework (box 2.17). of the health consequences of their decisions and to accept responsibility for health. health promotion policy combines diverse but complementary approaches, including legislation, fiscal measures, taxation, and organizational change. it is a coordinated action that leads to health, income, and social policies that foster greater equity. joint action contributes to ensuring safer and healthier goods and services, healthier public services, and cleaner, more enjoyable environments. health promotion policies require the identification of obstacles to the adoption of healthy public policies in non-health sectors, and ways of removing them. built on progress made from the declaration on primary health care at alma-ata, the aim was to make the healthier choice the easier choice for policy makers as well. the logo of the ottawa charter has been maintained by the who as the symbol and logo of health promotion. health promotion represents activities to enhance and embed the concept of building healthy public policy through: l building healthy public policy in all sectors and levels of government and society l enhancing both self help and social support l developing personal skills through information and education for health l enabling, mediating, and advocating healthy public policy in all spheres l creating supportive environments of mutual help and conservation of the natural environment l reorienting health services beyond providing clinical curative services with linkage to broader social, political, economic, and physical environmental components. (adapted from ottawa charter; health and welfare canada and world health organization, 1986) an effective approach to health promotion was developed in australia where, in the state of victoria, revenue from a cigarette tax has been set aside for health promotion purposes. this has the effect of discouraging smoking, and at the same time finances health promotion activities and provides a focus for health advocacy in terms of promoting cessation of cigarette advertising at sports events or on television. it also allows for assistance to community groups and local authorities to develop health promotion activities at the workplace, in schools, and at places of recreation. health activity in the workplace involves reduction of work hazards as well as promotion of a healthy diet and physical fitness, and avoidance of risk factors such as smoking and alcohol abuse. in the australian model, health promotion is not only the persuasion of people to change their life habits; it also involves legislation and enforcement towards environmental changes that promote health. for example, this involves mandatory filtration, chlorination, and fluoridation for community water supplies, vitamin and mineral enrichment of basic foods. primary care alliances of service providers are organized including hospitals, community health services serving a sub-district population for more efficient and comprehensive care. these are at the level of national or state policy, and are vital to a health promotion program and local community action. community-based programs to reduce chronic disease using the concept of community-wide health promotion have developed in a wide variety of settings. such a program to reduce risk factors for cardiovascular disease was pioneered in the north karelia project in finland. this project was initiated as a result of pressures from the affected population of the province, which was aware of the high incidence of mortality from heart disease. finland had the highest rates of chd in the world and in the rural area of north karelia the rate was even higher than the national average. the project was a regional effort involving all levels of society, including official and voluntary organizations, to try to reduce risk factors for chd. after 15 years of follow-up, there was a substantial decline in mortality with a similar decline in a neighboring province taken for comparison, although the decline began earlier in north karelia. in many areas where health promotion has been attempted as a strategy, community-wide activity has developed with participation of ngos or any valid community group as initiators or participants. healthy heart programs have developed widely with health fairs, sponsored by charitable or fraternal societies, schools, or church groups, to provide a focus for leadership in program development. a wider approach to addressing health problems in the community has developed into an international movement of "healthy cities". following deliberations of the health of towns commission chaired by edwin chadwick, the health of towns association was founded in 1844 by southwood smith, a prominent reform leader of the sanitary movement, to advocate change to reduce the terrible living conditions of much of the population of cities in the uk. the association established branches in many cities and promoted sanitary legislation and public awareness of the "sanitary idea" that overcrowding, inadequate sanitation, and absence of safe water and food created the conditions under which epidemic disease could thrive. in the 1980s, iona kickbush, trevor hancock, and others promoted renewal of the idea that local authorities have a responsibility to build health issues into their planning and development processes. this "healthy cities" approach promotes urban community action on a broad front of health promotion issues (table 2. 2). activities include environmental projects (such as recycling of waste products), improved recreational facilities for young people to reduce violence and drug abuse, health fairs to promote health awareness, and screening programs for hypertension, breast cancer, and other diseases. it combines health promotion with consumerism and returns to the tradition of local public health action and advocacy. the municipality, in conjunction with many ngos, develops a consultative process and program development approach to improving the physical and social life of the urban environment and the health of the population. in 1995, the healthy cities movement involved 18 countries with 375 cities in europe, canada, the usa, the uk, south america, israel, and australia, an increase from 18 cities in 1986. the model now extends to small municipalities, often with populations of fewer than 10,000. networks of healthy cities are the backbone of the movement, with more than 1400 member towns and cities across europe. the choice of core themes offers the opportunity to work on priority urban health issues that are relevant to all european cities. topics that are of particular concern to individual cities and/or are challenging and cutting edge for innovative public health action are especially emphasized. healthy cities encourages and supports experimentation with new ideas by developing concepts and implementing them in diverse organizational contexts. a healthy city is a city for all its citizens: inclusive, supportive, sensitive and responsive to their diverse needs and expectations. a healthy city provides conditions and opportunities that encourage, enable and support healthy lifestyles for people of all social groups and ages. a healthy city offers a physical and built environment that encourages, enables and supports health, recreation and well-being, safety, social interaction, accessibility and mobility, a sense of pride and cultural identity and is responsive to the needs of all its citizens. the apha's formulation of the public health role in 1995, entitled the future of public health in america, was presented at the annual meeting in 1996. the apha periodically revises standards and guidelines for organized public health services provided by federal, state, and local governments ( table 2 .4). these reflect the profession of public health as envisioned in the usa where access to medical care is limited for large numbers of the population because of a lack of universal health insurance. public health in the usa has been very innovative in determining risk groups in need of special care and finding direct and indirect methods of meeting those needs. european countries such as finland have called for setting public health into all public policy, which reflects the vital role that local and county governments can play in developing health-oriented policies. these include policies in housing, recreation, regulation of industrial pollution, road safety, promotion of smoke-free environments, bicycle paths, health impact assessment, and many other applications of health principles in public policy. public health involves both direct and indirect approaches. direct measures in public health include immunization of children, modern birth control, and chronic disease case finding -hypertension, diabetes, and cancer. indirect methods used in public health protect the individual by community-wide means, such as raising standards of environmental safety, ensuring a safe water supply, sewage disposal, and improved nutrition (box 2.18). in public health practice, the direct and indirect pproaches are both relevant. to reduce morbidity and mortality from diarrheal diseases requires an adequate supply of safe water and waste disposal, and also education of the individual in hygiene and the mother in use of ort, and rotavirus vaccination of all children. the targets of public health action therefore include the individual, family, community, region, or nation, as well as a functioning and health system adopting current best practices for health care and health protection. the targets for protection in infectious disease control are both the individual and the total group at risk. for vaccine-preventable diseases, immunization protects the individual but also has an indirect effect by reducing the risk even for non-immunized persons. in control of some diseases, individual case finding and management reduce risk of the disease in others and the community. for example, tb requires case finding and adequate care among high-risk groups as a key to community control. in malaria control, case finding and treatment are essential together with environmental action to reduce the vector population, to prevent transmission of the organism by the mosquito to a new host. control of ncds, where there is no vaccine for mass application, depends on the knowledge, attitudes, beliefs, and practices of individuals at risk. in this case, the social context is of importance, as is the quality of care to which the individual has access. control and prevention of noninfectious diseases involve strategies using individual and population-based methods. individual or clinical measures include professional advice on how best to reduce the risk of the disease by early diagnosis and implementation of appropriate therapy. population-based measures involve indirect measures with government action banning cigarette advertising, or direct taxation on cigarettes. mandating food quality standards, such as limiting the fat content of meat, and requiring food labeling laws are part of the control of cardiovascular diseases. the way individuals act is central to the objective of reducing disease, because many non-infectious diseases are dependent on behavioral risk factors of the individual's choosing. changing the behavior of the individual means addressing the way a person sees his or her own needs. this can be influenced by the provision of information, but how someone sees his or her own needs is more complex than that. an individual may define needs differently from the society or the health system. reducing smoking among women may be difficult to achieve if smoking is thought to reduce appetite and food intake, given the social message that "slim is beautiful". reducing smoking among young people is similarly difficult if smoking is seen as fashionable and diseases such as lung cancer seem very remote. recognizing how individuals define needs helps the health system to design programs that influence behavior that is associated with disease. public health has become linked to wider issues as health care systems are reformed to take on both individual and population-based approaches. public health and mainstream medicine have found increasingly common ground in addressing the issues of chronic disease, growing attention to health promotion, and economics-driven health care reform. at the same time, the social ecology approaches have shown success in slowing major causes of disease, including heart disease and aids, and the biomedical sciences have provided major new technology for preventing major health problems, including cancer, heart disease, genetic disorders, and infectious diseases. technological innovations unheard of just a few years ago are now commonplace, in some cases driving up costs of care and in others replacing older and less effective care. at the same time, resistance of important pathogenic microorganisms to antibiotics and pesticides is producing new challenges from diseases once thought to be under control, and newly emerging infectious diseases challenge the entire health community. new generations of antibiotics, antidepressants, antihypertensive medications, and other treatment methods are changing the way many conditions are treated. research and development in the biomedical to improve the quality of public health practice and performance of public health systems sciences are providing means of prevention and treatment that profoundly affect disease patterns where they are effectively applied. the technological and organizational revolutions in health care are accompanied by many ethical, economic, and legal dilemmas. the choices in health care include heart transplantation, an expensive life-saving procedure, which may compete with provision of funds and labor resources for immunizations for poor children or for health promotion to reduce smoking and other risk factors for chronic disease. new means of detecting and treating acute conditions such as myocardial infarction and peptic ulcers are reducing hospital stays, and improving long-term survival and quality of life. imaging technology has been an important development in medicine since the advent of x-rays in the early twentieth century. technology has forged ahead with high-technology instruments and procedures, new medication, genetic engineering, and important low-technology gains such as impregnated bed nets, simplified tests for hiv and tb, and many other "game changers". new technologies that can enable lower cost diagnostic devices, electronic transmission, and distant reading of transmitted imaging all open up possibilities for advanced diagnostic capacities in rural and less developed countries and communities. molecular biology has provided methods of identifying and tracking movement of viruses such as polio and measles from place to place, greatly expanding the potential for appropriate intervention. the choices in resource allocation can be difficult. in part, these add political commitment to improve health, competent professionally trained public health personnel, the public's level of health information, and legal protection, whether through individuals, advocacy, or regulatory approaches for patients' rights. these are factors in a widening methodology of public health. the centers for disease control and prevention (morbidity and mortality weekly report) in 1999 summarized 10 great achievements of public health in the usa, with an extension of the lifespan by over 30 years and improvements in many measures of quality of life. they were updated in a similar summary report in 2011, showing continuous progress, and a global version which was also encouraging in its scope of progress (table 2 .5). these achievements were also seen in all developed countries over the past century and are beginning to be seen in developing countries as well. they reflect a successful application of a broad approach to prevention and health promotion along with improved medical care and growing access to its benefits. in the past several decades alone, major new innovations are leading to greater control of cardiovascular disease, cancer prevention, and many other improvements to health affecting hundreds of millions of people. a similar 2011 report by the cdc shows global progress in the first decade of the twenty-first century, while mdg reports show progress on all eight target topics, although not at uniformly satisfactory rates. these achievements are discussed throughout this text. this successful track record is very much at the center of a new public health involving a wide range of programs and activities, shown to be feasible and benefiting from continuing advances in science and understanding of social and management issues affecting health care systems worldwide. public health issues have received new recognition in recent years because of a number of factors, including a growing understanding among the populace at different levels in different countries that health behavior is a factor in health status and that public health is vital for protection against natural or human-made disasters. the challenges are also increasingly understood: preparation for bioterrorism, avian influenza, rising rates of diabetes and obesity, high mortality rates from cancer, and a wish for prevention to be effective. health systems offer general population benefits that go beyond preventing and treating illness. appropriately designed and managed, they: l provide a vehicle to improve people's lives, protecting them from the vulnerability of sickness, generating a sense of life security, and building common purpose within society l ensure that all population groups are included in the processes and benefits of socioeconomic development l generate the political support needed to sustain them over time. health systems promote health equity when their design and management specifically consider the circumstances and needs of socially disadvantaged and marginalized populations, including women, the poor, and groups who experience stigma and discrimination, enabling social action by these groups and the civil society organizations supporting them. health systems can, when appropriately designed and managed, contribute to achieving the millennium development goals. the mdgs selected by the un in 2000 have eight global targets for the year 2015, including four directly related to public health (discussed above, box 2.15). these are a recognition and a challenge to the international community and public health as a profession and as organized systems. formal education in newly developing schools of public health is increasing in europe, including many countries of eastern europe, and beginning to develop in india and sub-saharan africa. but there is delay in establishing centers of postgraduate education and research in many developing countries which are concentrating their educational resources on training physicians. many physicians from developing nations are moving to the developed countries, which have become dependent on these countries for a significant part of their supply of medical doctors. progress in implementation of the mdgs is mixed in sub-saharan africa, making some progress in immunization, but falling back on other goals. proposals to renew global health targets following the 2015 end-stage of the mdg health goals will need to add a focus on ncds, which account for 60 percent of global deaths, including 8.1 million premature deaths below the age of 60 (undp). economic growth has been hampered by the global recession since 2008, which will affect continued progress with many other factors of changing population dynamics, the economics of prevention versus expensive treatment costs, and the high costs of health care. environmental degradation with high levels of carbon dioxide contamination is a growing concern, with disastrous global warming and consequent effects of drought, flooding, hurricane, and elevated particulate matter-induced asthma and effects on cardiovascular disease. the potential for the development of basic and medical sciences in genetics, nanotechnology, and molecular biology shows enormous promise for health benefits as yet unimagined. at the same time, the effectiveness of health promotion has shown dramatic successes in reducing the toll of aids, reducing smoking, and increasing consciousness of nutrition and physical fitness in the population, and of the tragic effects of poverty and poor education on health status. the ethics of public health issues are complex and changing with awareness that failure to act on strong evidence-based policies is itself ethically problematic. the future of public health is not as a solo professional sector; it is at the heart of health systems, without which societies are open to chronic and infectious diseases that are preventable, affecting the society as a whole in economic and development matters. there is an expanding role of private donors in global health efforts, such as the rotary club and the polio eradication program, gavi with immunization and bed-nets in sub-saharan africa, and bilateral donor countries' help in reducing the toll of aids in sub-saharan africa. the new public health has emerged as a concept to meet a whole new set of conditions, associated with increasing longevity and aging of the population, with the post-world war ii baby-boom generation reaching the over-65 age group facing the growing importance of chronic diseases. inequalities in health exist in and between affluent and developing societies, as well as within countries, even those having advanced health care systems. regional inequalities are seen across the european region in an east-west gradient and globally a north-south divide of extremes of inequality. the global environmental and ecological degradation and pollution of air and water present grave challenges for developed and developing countries worldwide. yet optimism can be derived from proven track records of success in public health measures that have already been implemented. many of the underlying factors are amenable to prevention through social, environmental, or behavioral change and effective use of medical care. the new public health idea has evolved since alma-ata, which articulated the concept of health for all, followed by a trend in the late 1970s to health in all policies and establishing health targets as a basis for health planning. during the late 1980s and early 1990s, the debate on the future of public health in the americas intensified as health professionals looked for new models and approaches to public health research, training, and practice. this debate helped to redefine traditional approaches of social, community, and preventive medicine. the search for the "new" in public health continued with a return to the health for all concept of alma-ata (renewed in 2008) and a growing realization that the health of both the individual and the society involves the management of personal care services and community prevention, with a comprehensive approach taking advantage of advancing technology and experience of best practices globally. the new public health is an extension of the traditional public health. it describes organized efforts of society to develop healthy public policies: to promote health, to prevent disease, and to foster social equity within a framework of sustainable development. a new, revitalized public health must continue to fulfill the traditional functions of sanitation, protection, and related regulatory activities, but in addition to its expanded functions. it is a widened philosophy and practical application of many different methods of addressing health, and preventing disease and avoidable death. it necessarily addresses inequities so that programs need to meet special needs of different groups in the population according to best standards, limited resources, and population needs. it is proactive and advocates interventions within legal and ethical limits to promote health as a value in and of itself and as an economic gain for society as well for its individual members. the new public health is a comprehensive approach to protecting and promoting the health status of the individual and the society, based on a balance of sanitary, environmental, health promotion, personal, and community-oriented preventive services, coordinated with a wide range of curative, rehabilitative, and long-term care services. it evolves with new science, technology, and knowledge of human and systems behavior to maximize health gains for the individual and the population. the new public health requires an organized context of national, regional, and local governmental and non-governmental programs with the object of creating healthful social, nutritional, and physical environmental conditions. the content, quality, organization, and management of component services and programs are all vital to its successful implementation. whether managed in a diffused or centralized structure, the new public health requires a systems approach acting towards achievement of defined objectives and specified targets. the new public health works through many channels to promote better health. these include all levels of government and parallel ministries; groups promoting advocacy, academic, professional, and consumer interests; private and public enterprises; insurance, pharmaceutical, and medical products industries; the farming and food industries; media, entertainment, and sports industries; legislative and law enforcement agencies; and others. the new public health is based on responsibility and accountability for defined populations in which financial systems promote achievement of these targets through effective and efficient management, and cost-effective use of financial, human, and other resources. it requires continuous monitoring of epidemiological, economic, and social aspects of health status as an integral part of the process of management, evaluation, and planning for improved health. the new public health provides a framework for industrialized and developing countries, as well as countries in political-economic transition such as those of the former soviet system. they are at different stages of economic, epidemiological, and sociopolitical development, each attempting to ensure adequate health for its population with limited resources. the challenges are many, and affect all countries with differing balances, but there is a common need to seek better survival and quality of life for their citizens (table 2 .6). the object of public health, like that of clinical medicine, is better health for the individual and for society. public health works to achieve this through indirect methods, such as by improving the environment, or through direct means such as preventive care for mothers and infants or other atrisk groups. clinical care focuses directly on the individual patient, mostly at the time of illness. but the health of the individual depends on the health promotion and social programs of the society, just as the well-being of a society depends on the health of its citizens. the new public health consists of a wide range of programs and activities that link individual and societal health. the "old" public health was concerned largely with the consequences of unhealthy settlements and with safety of food, air, and water. it also targeted the infectious, toxic, and traumatic causes of death, which predominated among young people and were associated with poverty. a summary of the great achievements of public health in the twentieth and in the early twenty-first century in the industrialized world is included in chapter 1 and throughout this text. these achievements are reflective of public health gains throughout the industrialized world and are encourage and leverage national, state, and local partnerships to build a stronger foundation for public health preparedness and investigate health problems and health hazards in the community 3. inform, educate, and empower people about health issues 4. mobilize community partnerships to identify and solve health problems 5. develop policies and plans that support individual and community health efforts 6. enforce laws and regulations that protect health and ensure safety 7 evaluate effectiveness, accessibility, and quality of personal and population-based health services vision, mission and goals guidelines on food fortification with micronutrients. who, geneva. alliance for health policy and systems research 10 essential public health services healthy communities, 2000. model standards for community attainment of the year 2000 national health objectives determinants of adult mortality in russia: estimates from sibling data commission on social determinants and health. closing the gap in a generation: health equity through action on the social determinants of health compression of morbidity in the elderly institute of medicine. who will keep the public healthy? educating public health professionals for the 21st century global alliance for vaccine and immunization (gavi) chronic disease prevention and the new public health the evolution, impact and significance of healthy cities/healthy communities world health organization. ottawa charter for health promotion: an international conference on health promotion behavioral and social sciences and public health at cdc. mmwr health in all policies: seizing opportunities, implementing policies. ministry of social affairs and health new perspectives on the health of canadians: a working document new perspective on the health of canadians: 28 years later the us healthy people initiative: its genesis and its sustainability mortality from cardiovascular and cerebrovascular diseases in europe and other areas of the world: an update strategic review of health inequalities in england post. department of health primary care (extended version): ten key actions could globally ensure a basic human right at almost unnoticeable cost public health in europe: power, politics, and where next health: a vital investment for economic development in eastern europe and central asia. european observatory on health systems and policies. who, european regional office it is not just the broad street pump addressing the epidemiologic transition in the former soviet union: strategies for health systems and public health reform in russia what is the "new public health"? millenium development goals: 2013 progress chart united nations development programme, millennium development goals. eight goals for healthy people 2020 healthy people. the surgeon general's report on health promotion and disease prevention the millennium development goals: a cross-sectoral analysis and principles for goal-setting after selective primary health care: an interim strategy for disease control in developing countries declaration of alma-ata. international conference on primary health care healthy cities networks across the who, european region preamble to the constitution of the world health organization as adopted by the international health conference regional office for europe. health 21 -health for all in the 21st century. who regional office for europe, copenhagen. world health organization, 2012. regional office for europe. who european healthy cities network. available at:. who regional office for europe leading health indicators selected for 2010 incorporate the original 467 objectives in healthy people 2010, which served as a basis for planning public health activities for many state and community health initiatives. for each of the leading health indicators, specific objectives and subobjectives derived from healthy people 2010 are used to monitor progress. the specific objectives set for healthy people 2020 are listed in box 2.16. thirteen new topic areas are listed for 2020, such as older adults, genomics, dementias, and social determinants of health. these provide guidelines for national, state, and local public health agencies as well as insurance providers, primary care services, and health promotion advocates. a key issue will be in reducing regional, ethnic, and socioeconomic health disparities.the process of working towards health targets in the usa has moved down from the federal level of government to the state and local levels. professional organizations, ngos, as well as community and fraternal organizations are also involved. the states are encouraged to prepare their own targets and implementation plans as a condition for federal grants, and many states require county health departments to prepare local profiles and targets.diffusion of this approach encourages state and local initiatives to meet measurable program targets. it also sets a different agenda for local prestige in competitive terms, with less emphasis on the size of the local hospital or other agencies than on having the lowest infant mortality or the least infectious disease among neighboring local authorities. the who european region document "health 21 -health for all in the 21st century" addresses health in the twentyfirst century, with 21 principles and objectives for improving the health of europeans, within and between countries of europe. the health 21 targets include:1. closing the health gap between countries. 2. closing the health gap within countries. 3. a healthy start in life (supportive family policies). 4. health of young people (policies to reduce child abuse, accidents, drug use, and unwanted pregnancies). 5. healthy aging (policies to improve health, self-esteem, and independence before dependence emerges). 6. improving mental health. 7. reducing communicable diseases. 8. reducing non-communicable diseases. 9. reducing injury from violence and accidents. 10. a healthy and safe physical environment. 11. healthier living (fiscal, agricultural, and retail policies that increase the availability of and access to and consumption of vegetables and fruits). 12. reducing harm from alcohol, drugs, and tobacco. 13. a settings approach to health action (homes should be designed and built in a manner conducive to sustainable health and the environment).14. multisectoral responsibility for health.15. an integrated health sector and much stronger emphasis on primary care. 16. managing for quality of care using the european health for all indicators to focus on outcomes and compare the effectiveness of different inputs. the uk national health service (nhs) has semi-autonomous units in england, scotland, wales, and northern ireland. they are funded from the central uk nhs but with autonomy within national guidelines. the nhs has defined national health outcomes for improvements grouped around five domains, each comprised of key indicators aimed at improving health with reducing inequalities. l preventing people from dying prematurely from causes amenable to health care for all ages: l the target diseases include cardiovascular, respiratory, and liver diseases, and cancer (with focus on cancer of breast, lung, and colorectal cancer) l reducing premature death in people with serious mental illnesses l reducing infant mortality, neonatal mortality, still births, and deaths in young children l increasing 5-year survival for children with cancer. health improvement; help people to live healthy lifestyles, healthy choices, reduce health inequalities, protection from major incidents and other threats, while reducing health inequalities. l health care, public health and preventing premature mortality; reduce the numbers of people living with preventable ill-health and people dying prematurely, while reducing the gap between communities.source: uk department of health. available at: https://www.gov.uk/government/organisations/department-of-health/about#our-priorities, https:// www.gov.uk/government/uploads/system/uploads/attachment_data/ file/193619/improving-outcomes-and -supporting-transparency-part-1a.pdf. pdf, and https://www.gov.uk/government/uploads/system/uploads/attach-ment_data/file/127106/121109-nhs-outcomes-framework-2013-14.pdf. pdf [accessed 24 june 2013] . national policy in health ultimately relates to health of the individual. the various concepts outlined in the health field concept, community-oriented primary health care, health targets, and effective management of health systems, can only be effective if the individual and his or her community are knowledgeable participants in seeking solutions. involving the individual in his or her own health status requires raising levels of awareness, knowledge, and action. the methods used to achieve these goals include health counseling, health education, and health promotion (figure 2 .6).health counseling has always been a part of health care between the doctor or nurse and the patient. it raises levels of awareness of health issues of the individual patient. health education has long been part of public health, dealing with promoting consciousness of health issues in selected target population groups. health promotion incorporates the work of health education but takes health issues to the policy level of government and involves all levels of government and ngos in a more comprehensive approach to a healthier environment and personal lifestyles.health counseling, health education, and health promotion are among the most cost-effective interventions for improving the health of the public. while costs of health care are rising rapidly, demands to control cost increases should lead to greater emphasis on prevention, and adoption of health education and promotion as an integral part of modern life. this should be carried out in schools, the workplace, the community, commercial locations (e.g., shopping centers), and recreation centers, and in the political agenda.psychologist abraham maslow described a hierarchy of needs of human beings. every human has basic requirements including physiological needs of safety, water, food, warmth, and shelter. higher levels of needs include recognition, community, and self-fulfillment. these insights supported observations of efficiency studies such as those of elton mayo in the famous hawthorne effect in the 1920s, showing that workers increased productivity when acknowledged by management in the objectives of the organization (see chapter 12). in health terms, these translate into factors that motivate people to positive health activities when all barriers to health care are reduced.modern public health faces the problem of motivating people to change behavior; sometimes this requires legislation, enforcement, and penalties for failure to comply, such as in mandating car seat-belt use. in other circumstances it requires sustained performance by the individual, such as the use of condoms to reduce the risk of sti and/or hiv transmission. over time, this has been developed into a concept known as knowledge, attitudes, beliefs, and practices (kabp), a measurable complex that cumulatively affects health behavior (see chapter 3). there is often a divergence between knowledge and practice; for example, the knowledge of the importance of safe driving, yet not putting this into practice. this concept is sometimes referred to as the "kabp gap". the health belief model has been a basis for health education programs, whereby a person's readiness to take action for health stems from a perceived threat of disease, a recognition of susceptibility to disease and its potential severity, and the value of health. action by an individual may be triggered by concern and by knowledge. barriers to appropriate action may be psychological, financial, or physical, including fear, time loss, and inconvenience. spurring action to avoid risk to health is one of the fundamental goals in modern health care. the health belief model is important in defining any health intervention in that it addresses the emotional, intellectual, and other barriers to taking steps to prevent or treat disease.health awareness at the community and individual levels depends on basic education levels. mothers in developing countries with primary or secondary school education are more successful in infant and child care than less educated women. agricultural and health extension services reaching out to poor and uneducated farm families in north america in the 1920s were able to raise consciousness of safe self-health practices and good nutrition, and when this was supplemented by basic health education in schools, generational differences could be seen in levels of awareness of the importance of balanced nutrition. secondary prevention with diabetics and patients with chd hinges on education and awareness of nutritional and physical activity patterns needed to prevent or delay a subsequent myocardial infarction. the who sponsored the first international conference on health promotion held in ottawa, canada, in 1986 ( figure 2.7) . the resulting ottawa charter defined health promotion and set out five key areas of action: building healthy public policy, creating supportive environments, strengthening community action, developing personal skills, and reorienting health services. the ottawa charter called on all countries to put health on the agenda of policy makers in all sectors and at all levels, directing them to be aware a typical healthy city has a population in the multiple thousands, often multilingual, with an average middleclass income. a healthy cities project builds a coalition of municipal and voluntary groups working together in a continuing effort to improve quality of service, facilities, and living environment. the city is divided into neighborhoods, engaged in a wide range of activities fostered by the project. municipalities have traditionally had a leading role in sanitation, safe water supply, building and zoning laws and regulation, and many other responsibilities in public health (see chapter 10). the healthy cities or communities movement has elevated this to a higher level with policies to promote health in all actions. some examples are listed of municipal, advocacy group, and higher governmental activities for healthier city environments: working with senior levels of government, other departments in the municipalities, religious organizations, private donors, and the ngo sector to innovate and especially to improve conditions in poverty-afflicted areas of cities is a vital role for health-oriented local political leadership. human ecology, a term introduced in the 1920s and revived in the 1970s, attempted to apply theory from plant and animal life to human communities. it evolved as a branch of demography, sociology, and anthropology, addressing the social and cultural contexts of disease, health risks, and human behavior. human ecology addresses the interaction of humans with and adaptation to their social and physical environment.parallel subdisciplines of social, community, and environmental psychology, medical sociology, anthropology, and other social sciences contributed to the development of this academic field with wide applications in health-related issues. this led to the incorporation of qualitative research methods alongside the quantitative research methods traditionally emphasized in public health, providing crucial insights into many public health issues where human behavior is a key risk factor.health education developed as a discipline and function within public health systems in school health, rural nutrition, military medicine, occupational health, and many other aspects of preventive-oriented health care, and is discussed in later chapters of this text. directed at behavior modification through information and raising awareness of consequences of risk behavior, this has become a longstanding and major element of public health practice in recent times, being almost the only effective tool to fight the epidemic of hiv and the rising epidemic of obesity and diabetes.health promotion as an idea evolved, in part, from marc lalonde's health field concepts and from growing realization in the 1970s that access to medical care was necessary but not sufficient to improve the health of a population. the integration of the health behavior model, social ecological approach, environmental enhancement, or social engineering formed the basis of the social ecology approach to defining and addressing health issues (table 2 .3).individual behavior depends on many surrounding factors, while community health also relies on the individual; the two cannot be isolated from one another. the ecological perspective in health promotion works towards changing people's behavior to enhance health. it takes into account factors not related to individual behavior, which are determined by the political, social, and economic environment. it applies broad community, regional, or national approaches that are needed to address severe public health problems, such as controlling hiv infection, tb, malnutrition, stis, cardiovascular disorders, violence and trauma, and cancer. beginning to affect the health situation in countries in transition from the socialist period. countries emerging from developing status are also showing signs of mixed progress in the dual burden of infectious and maternal/child health issues, along with growing exposure to the chronic diseases of developed nations such as cardiovascular diseases, obesity, and diabetes. the new public health synthesizes traditional pub lic health with management of personal services and community action for a holistic approach. evaluation of costeffective public health and medical interventions to reduce the burden of disease also contributes to the need to seek and apply new approaches to health. the new public health will continue to evolve as a framework drawing on new ideas, science, technology, and experiences in public health throughout the world. it must address the growing recognition of social inequality in health, even in developed countries with universal health programs with improved education and social support systems. for a complete bibliography and guidance for student reviews and expected competencies please see companion web site at http://booksite.elsevier.com/9780124157668 bibliography key: cord-304056-2bo0s0hz authors: lezotre, pierre-louis title: part i state of play and review of major cooperation initiatives date: 2014-12-31 journal: international cooperation, convergence and harmonization of pharmaceutical regulations doi: 10.1016/b978-0-12-800053-3.00002-1 sha: doc_id: 304056 cord_uid: 2bo0s0hz abstract the basic principle of international cooperation is to establish bilateral and multilateral efforts to leverage the human, scientific and financial resources and the knowledge and experience of other key regulatory authorities to avoid duplication of efforts, to make activities more efficient and to allow the focussing of limited resources on higher-risk areas of concern. this increased cooperation between worldwide regulators has necessitated proactive deliberate efforts towards convergence/harmonisation of regulation, practices and requirements to eliminate or reduce differences. cooperation and harmonisation of standards in the pharmaceutical domain are already a reality and have become increasingly important during recent decades, with a high level of commitment to these activities by all stakeholders. the worldwide drug regulatory authorities (dras) have been working to end an isolationist attitude that cannot resolve current worldwide issues and challenges caused by an ever increasing globalisation. as a result, many cooperation and harmonisation initiatives have been established at the bilateral, regional and global levels as a response to the changing geo-economic-political situation. the spectrum of collaboration varies from simple informal technical cooperation to full integration of systems and regulations. indeed, all these initiatives can be very different in scope (some are part of a broader harmonisation initiative), level of harmonisation (depending on the political support/commitment), organisation (well-structured versus simple discussion) or advancement (established process vs. pilot projects), but they all work towards convergence of requirements and/or practices. all these multiple worldwide cooperation and harmonisation programmes have evolved rapidly over the past decades. this book section provides the current status of this complex and broad phenomenon of cooperation, convergence and harmonisation in the pharmaceutical sector. it reviews all major global, regional and bilateral cooperation initiatives. many aspects of increased globalization also have profound implications on pharmaceutical regulation worldwide. in general, globalization of the economy (with increased travel of people and exchange of goods, finance, and information), and also globalization of the pharmaceutical market (including development, manufacture, and distribution activities), requires increased cooperation and harmonization of pharmaceutical standards and regulation. pharmaceutical industries have asked for better harmonization of requirements for the development and manufacture of pharmaceutical products to avoid duplication of work that ultimately creates delays in drug availability [23] . in this context, harmonization of pharmaceutical regulations has naturally become an important topic of discussion among worldwide drug regulatory authorities (dras). over the past several decades, they have been working to end an isolationist attitude that cannot resolve current worldwide issues and challenges. as a result, many cooperative initiatives (bilateral, regional, and global) were established, and harmonization efforts have been enhanced. all these initiatives can be very different in scope (some are part of a broader harmonization initiative), level of harmonization (depending on the political support/commitment), organization (well structured versus simple discussion), or advancement (established process versus pilot projects), but they all work towards harmonization of requirements and/or practices. increased exchange of information on a regular basis (e.g., more than 26 countries and international organizations from australia to vietnam now have agreements to share information with the united states food and drug administration [us fda]) [24] also contributes to the natural convergence of requirements and practices. harmonization models can be distinguished by their scope and objectives. indeed, the spectrum of collaborations varies from simple technical cooperation to full integration of systems and regulations: ▸ integration model: in this type of agreement, most of the time driven by political decision, deeper harmonization of regulation is achieved with the creation of supranational central authorities in order to support integration and/or creation of a single market (e.g., eu, the association of southeast asian nations [asean] ). in this case, harmonization of standards and regulations is critical in reducing trade barriers. in this model, countries give up some of their autonomy on certain matters by transferring the power to make decisions to the common supranational authority or by automatically recognizing decisions from the other party (via mutual agreement mechanisms). the african medicines registration harmonization (amrh) initiative has defined five identifiable levels of harmonization ( figure 1 ). to facilitate cooperation, a mutual recognition agreement (or arrangement) (mra) can be signed by one or more parties to mutually recognize or accept some or all aspects of one another's requirements. they can be concluded at the technical level (e.g., the status and future plans," november 2009. confidentiality arrangements between the us fda and european medicines agency [ema] , or the mra between eu and australia) or at the government level (e.g., european treaty). these multilateral initiatives are major projects as they involve multiple organizations and countries and represent the highest degree of harmonization. the objective of this technical and scientific intergovernmental cooperation is to globally discuss scientific issues that support the decisions made by individual governments and international regulatory bodies in order to achieve global scientific consensus. the goal is to facilitate the development of new medicines and to make them available to the maximum number of people worldwide. there is no intent of full integration of systems and regulations. the main difficulty faced by these initiatives is the complexity and management of the structure due to the important number of participants (e.g., the world health organization [who] has 194 member states) and the diversity of needs, challenges, and level of development of its members. the world health organization (who) was established in 1948 as a specialized agency of the united nations (un) [25] . it is accountable to its member states and works closely with other entities of the un system. this agency has a very broad scope of responsibilities as it is the directing and coordinating authority for international health matters and public health within the un system. who is well known for some of its work (e.g., the coordination of influenza surveillance and monitoring activities, emergency assistance to people affected by disasters, mass immunization campaigns or actions against human immunodeficiency virus/acquired immunodeficiency syndrome [hiv/aids], tuberculosis, and malaria). however, who undertakes many more activities because it is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries, and monitoring and assessing health trends. most of these core functions, as further defined in its "11th general programme of work," [26] rely on cooperation and harmonization of standards. this focus on regional and global collaboration, and especially aid from developed countries to developing countries, is aligned with the un millennium development goals (mdgs). a a the united nations millennium development goals (mdgs) are eight international goals that un member states (and international organizations) have agreed to achieve by the year 2015. they are derived from the united nations millennium declaration, signed in september 2000, which endorsed a framework for development and commits world leaders to combat poverty, hunger, disease, illiteracy, environmental degradation, and discrimination against women. these mdgs are interdependent and several relate either directly or indirectly to health. who is therefore very involved in this process and works with countries to achieve the health-related mdgs. indeed, the objective of these mdgs is that countries and development partners work together to improve the global situation and resolve major issues. a number of specific targets and indicators have been identified to monitor progress towards the goals. goal 8 ("develop a global partnership for development") specifically recognizes the role of developed nations and addresses global cooperation and partnerships. who has worked in the area of pharmaceuticals since its creation approximately 60 years ago. during this time, many products and services have been created that are widely recognized as core functions of who. the role of who in pharmaceutical regulations is based on its constitutional mandate and various world health assembly (wha) resolutions. this support is twofold. one aspect relates to the development of internationally recognized norms, standards, and guidelines. the second relates to providing guidance, technical assistance, and training in order to enable countries to implement global guidelines to meet their specific medicines regulatory environment and needs [27] . all countries that are members of the un may become members of who by accepting its constitution. other countries may be admitted as members when their application has been approved by a simple majority vote of the world health assembly (wha). territories that are not responsible for the conduct of their international relations may be admitted as associate members upon application made on their behalf by the member or other authority responsible for their international relations. members of who are grouped according to regional distribution. who's strength lies in its neutral status and nearly universal membership. today, it represents 194 countries and two associate members (puerto rico and tokelau). one country is an observer (vatican) [28, 29] . the organization is headed by the director-general, b but the wha is the supreme decisionmaking body for who. it generally meets in geneva, switzerland in may of each year, and is attended by delegations from all member states. its main function is to determine the policies of the organization. the health assembly also appoints the director-general (on the nomination of the executive board), supervises the financial policies of the organization, and reviews and approves the proposed budget. the work of the assembly is supported by the executive board, which it elects. this executive arm of the assembly is composed of 34 members technically qualified in the health field. members are elected for three-year terms. the main board meeting, at which the agenda for the forthcoming health assembly is agreed upon and resolutions for forwarding to the health assembly are adopted, is held in january. a second shorter meeting in may, immediately after the health assembly, is held to address more administrative matters. the primary functions of the board are to give effect to the decisions and policies of the health assembly, to advise it, and generally to facilitate its work. under the leadership of the director-general, c more than 8,000 people from more than 150 countries work for who. this who staff includes health professionals (including medical doctors, public health specialists, epidemiologists, and scientists) as well as managers, economists, administrators, and other professionals. they are located in country offices, six regional offices, and at the headquarters in geneva, switzerland [30] . one of the unique aspects of who is its decentralized structure. who's work is a great combination of actions at the country, regional, and global levels. these efforts to decentralize its structure are aimed at getting closer to the ground (field) where decisions made can be more responsive to actual needs. indeed, this decentralized and regionalized structure provides who with multiple opportunities for engaging with countries. who's global headquarters is located in geneva, switzerland. the team based at the global headquarters supports and builds on all of the regional and local efforts. it sets global policies and standards, facilitates technical support to regions and countries, monitors and publicizes progress, and helps mobilize political and financial support. at the who headquarters, medicine activities are conducted within the cluster of health systems and services (hss) and are coordinated by the department of essential medicines and health products (emp). this department (which employs about 100 staff members [31] ) is involved in the harmonization of pharmaceutical regulations because it coordinates various activities in the areas of quality assurance (e.g., the international pharmacopoeia, international nonproprietary names [inn] , prequalification of medicines, counterfeit medicines), regulation and legislation (e.g., international conference of drug regulatory authorities [icdras]), and safety and efficacy (e.g., drug alerts). these activities comprise guideline development, workshops, and training courses, coordination and promotion of pharmacovigilance for global medicine safety, regulatory and other information exchange, and review of narcotic and psychotropic substances. who member states are grouped into six regions, each of them having a regional office: ▸ who regional office for africa in brazzaville, republic of congo. ▸ who regional office for europe in copenhagen, denmark. ▸ who regional office for southeast asia in new delhi, india. ▸ who regional office for the americas/pan american health organization (paho) in washington dc, united states. ▸ who regional office for the eastern mediterranean in cairo, egypt. ▸ who regional office for the western pacific in manila, the philippines. each of who's regional offices are the first point of contact for country offices that need extra technical or financial help. these regional offices also give special attention to adapting global policies to fit specific needs in their regions. indeed, the regional level is important in the who organization as it links the global strategy and plan with the country's reality and needs. they play a key role in the implementation of who norms and standards by ensuring that: ▸ country and regional needs are taken into consideration when who norms and standards are developed ▸ global guidelines and internationally recognized norms and standards are appropriately implemented in their regions (in the context of their own specific regulatory environment and challenges) by providing guidance, technical assistance, and training in addition to global activities coordinated from who headquarters, who regional and country offices can also carry out a variety of medicine-related activities specific to their regions. in addition to the regional and headquarters offices, who has 145 country offices that cover 159 member states. d there are also two field offices (the who humanitarian assistance office in pristina, kosovo and the west bank and gaza office) and offices covering two different areas, the us-mexican border field office in el paso, texas (us), and the office of caribbean program coordination in barbados. who has also established "who liaison offices" in key locations (e.g., at the european union in brussels, belgium, at the african union and the economic commission for africa in addis ababa, ethiopia, in washington dc, us, and at the un in new york city) and more than 10 "technical offices" (e.g., the european observatory on health systems and policies in berlin, germany) [32] . d some countries that do not have a physical who country office are served by the who representative of another country (for instance, the who representative to malaysia covers not just malaysia, but also brunei, darussalam, and singapore) . approximately 40% of who country offices are either owned or supported by the government and ministries of health. some of these who country offices are located in independent premises either rented or owned by who, while others are located within ministries of health or un common premises. these country offices are led by the head of who office (hwo), who are designated by the director-general and by the respective regional directors. the hwo manages who core functions at the country level and provides leadership in the following key functional areas: ▸ advocacy, partnership, and representation ▸ support for policy development and technical cooperation ▸ administration and management it is important to note that who is focused on needs of countries and emphasizes in particular the decentralization process that is aimed at increasing who's impact on health and development at the country level. this country focus tailors who's technical collaboration to the needs and capacities of each member state, with a special emphasis on the poorest countries and most fragile contexts. the key principles guiding who cooperation in countries are [33] : ▸ ownership of the development process and projects by the country ▸ alignment with national priorities and strengthening national systems ▸ harmonization with the work of sister un agencies and other partners in the country towards better aid effectiveness ▸ collaboration as a two-way process that fosters member states' contributions to the global health agenda who's country presence is the platform for effective cooperation with countries for advancing the global agenda, contributing to national health strategies and planning, and bringing country realities and perspectives into global policies and priorities. according to the above principles and its structure, who is indeed able to focus on countries' needs and better define its priorities to actively support the development, implementation, monitoring, and assessment of national health policies, strategies, and plans. but it also allows for better monitoring implementation of global agreements such as the millennium development goals (mdgs) and the international health regulations (ihr [2005] ). these activities in countries are governed by the country cooperation strategy (ccs), which is who's key instrument to guide its work in countries. it is a medium-term vision (generally covering four to six years) for its technical cooperation with a given member state, in support of the country's national health policy, strategy, or plan. it is an organization-wide reference that guides partnership, planning, budgeting, and resource allocation. who also established the department of country focus (cco) to support and advocate for who country offices, develop the capacity of who country teams for effective engagement in partnership platforms, and facilitate and monitor who's engagement in the aid effectiveness agenda at the country level. for example, cco provides support for the development, dissemination, and use of the country cooperation strategy. ▸ expert committees: expert committees have an important role in who activities. they are defined in the who constitution. e in addition to the constitution, regulations for expert advisory panels and committees are also included in the who document entitled "regulations for expert advisory panels and committees." f an expert committee is the highest official advisory body to the director-general of who as well as to all the organization's member states. it is established by the wha or by an executive board decision. there are various types of who expert committees. for example, the who expert committee on specifications for pharmaceutical preparations (ecspp) has been providing, for more than 60 years, recommendations and tools to assure the quality of medicines from their development phase to their final distribution to patients. there is also the expert committee on biological standardization (ecbs), which is as old as the ecspp. in addition to its structured organization, the who has been supported since its creation by its "collaborating centers." these are institutions such as research institutes and parts of universities or academies that are designated by the director-general to carry out activities in support of who programs. currently there are over 800 who collaborating centers in over 80 member states working with who in several areas (one of them being "pharmaceuticals"). several collaborating centers may exist for the same topic (e.g., international classifications or traditional medicines) and form a specific network to help who regarding this specific topic. of causes of death. who also started to publish its bulletin, which is today an international peer-reviewed monthly journal of public health with a special focus on developing countries. j in its early years, who's priority was the prevention and control of specific diseases (e.g., malaria, tuberculosis, smallpox, yaws, onchocerciasis, and venereal disease), some of which are still a problem today. they also focused on women's and children's health and nutrition, and environmental sanitation. who's work has since grown to cover other (sometimes new) health problems (including polio, hiv/aids, and severe acute respiratory syndrome [sars] ), but it also works to control tobacco and alcohol use and to promote diet and physical activity to prevent the four main noncommunicable diseases (cardiovascular disease, cancer, chronic lung diseases, and diabetes) [36] . who has also been increasingly involved in the global regulation and control of medicines. in 1977, the first essential medicines list was released two years after the wha introduced the concepts of "essential drugs" and "national drug policy." one hundred and fifty-six countries today have a national list of essential medicines. who has also funded many projects over the years to facilitate global cooperation and harmonization of standards. the purpose of all these activities in the pharmaceutical domain is aimed at increasing global and equitable access to safe, effective medicines of assured quality. this specific goal is derived from the overall objective of who to improve and maintain global public health. this objective has been regularly reiterated in several wha resolutions and during other events such as the icdras. in 1978, the international conference on primary health care (alma-ata, kazakhstan) set the historic goal of "health for all," to which who continues to aspire. more recently, the un mdgs have further clarified the objectives and priorities of global cooperation derived from the un millennium declaration signed in september 2000. one of who's mandates is "to develop, establish and promote international standards with respect to food, biological, pharmaceutical and similar products" [37] . who member states (especially developing countries) rely on who for expertise and guidance in regulation, safety, and quality assurance of medicines through development and promotion of international norms, standards, guidelines, and nomenclature. to achieve this goal, who relies on cooperation and uses its decentralized organization to facilitate implementation of projects and agreed-upon standards. the harmonization activities are initiated according to the who's medicines strategy. trigger actions to initiate a new project or development of a standard are given at different levels and bodies (i.e., the wha, executive board resolutions, icdras, or who programs and j since it was first published in 1948, the bulletin has become one of the world's leading public health journals. as the flagship periodical of who, the bulletin draws on both who experts (as editorial advisors, reviewers, and authors) and external collaborators. clusters). these projects and standards are then developed through a vast global consultation process involving who member states, national and regional authorities, international agencies, and with specialists from industry, national institutions, nongovernmental organizations, etc. project updates and approved standards become publically available through the extensive list of who publications to support national, regional, and global health strategies. k because the global dissemination and exchange of information is important, who secures the broad international distribution of its publications and encourages their translation. l this ensures the widest possible availability of authoritative information and guidance on health matters. the department of emp, based at the who global headquarters in geneva, works closely with expert committees, other regulators, and relevant who collaborating centers to develop and implement these harmonization activities. this department coordinates these activities globally with the support of who's regional advisors and country project staff in each of the regional offices and many country offices. each of the regional offices has two to five professionals coordinating the medicines strategy, and 40 who country offices have full-time pharmaceutical policy experts [38] . it is worth mentioning that in addition to its normative activities and harmonization projects, who also assists countries in capacity building by assessing regulatory systems. it does this by facilitating cooperation and information exchange between countries and by providing technical support. it is very important to involve all countries (whatever their development level), and to facilitate the implementation of norms and standards. finally, who has developed relationships with a lot of nongovernmental and civil society organizations on a global basis via the civil society initiative (csi) , and also at regional and national levels. the objectives of who's relations with nongovernmental organizations (ngos) are to promote the policies, strategies, and activities of who to facilitate their implementation. who has a large repertoire of global normative work relevant for all levels of development. in the area of medicines, a lot of standards, norms, and classifications have been developed, and forums/networks have been created to enhance global cooperation. important initiatives are presented below. k who publishes practical manuals, handbooks, and training material; internationally applicable guidelines and standards; reviews and analyses of health policies, programs, and research; and state-of-the-art consensus reports that offer technical advice and recommendations for decision makers. also, the who technical report series makes available the findings of various international groups of experts that provide who with the latest scientific and technical advice on a broad range of medical and public health subjects. l in 1978, the world health assembly turned multilingualism into a who policy by establishing six official languages (arabic, chinese, english, french, russian, and spanish) . since the adoption of a 1998 resolution, all governing bodies' documents and corporate materials have been made available online in all official languages. the international conference of drug regulatory authorities (icdras) provides drug regulatory authorities of who member states with a forum to meet and discuss ways to strengthen collaboration and harmonization of pharmaceutical regulations. this is a key accomplishment of who that has been instrumental in guiding dras, who, and interested stakeholders to develop national, regional, and international medicines regulation, and it continues to be a cornerstone of international harmonization of medicines regulation. these conferences have been held since 1980, and they have involved both developed and developing countries. the 14th icdras, held in singapore from november 30 to december 3, 2010, involved 345 participants from over 90 agencies. the 15th icdras, which took place in tallinn, estonia from october 23 to 26, 2012, was attended by over 300 participants from 100 countries. the aim of these conferences is to promote the exchange of information and collaborative approaches to issues of common concern. topics discussed include quality issues, herbal medicines, homeopathy, regulatory reform, medicine safety, counterfeiting, regulation of clinical trials, harmonization, new technologies, and e-commerce. recommendations are proposed for actions to take among agencies, who, and related institutions. it is worth mentioning that the idea to create ich began to formulate after background discussions between the us, the european union (eu), and japan during the 5th icdras conference in paris, france in 1989 [39] . as a platform was established to develop international consensus, the icdras continues to be an important tool for who and dras in their efforts to harmonize regulation and improve the safety, efficacy, and quality of medicines on a worldwide basis. the who constitution mandates the production of international classifications on health. these internationally endorsed classifications, developed through the who network m are very important as they facilitate the storage, retrieval, analysis, interpretation, and comparison of data. they support global cooperation and harmonization by providing a consensual framework that governments, healthcare providers, and consumers can use as a common language. they also permit the comparison of data not only within populations over time, but also between populations. who reference classifications are the international classification of diseases (icd), the international classification of functioning, disability and health (icf), and the international classification of health interventions (ichi). in addition, related and derived classifications (based on the reference classifications) have also been developed (e.g., the anatomical therapeutic chemical classification with defined daily doses (atc/ddd) that classifies m who has designated a number of collaborating centers to work with it in the development, dissemination, maintenance, and use of the who international classifications. therapeutic drugs according to the organ/system on which they act, and their chemical, pharmacological, and therapeutic properties). the who international clinical trials registry platform (ictrp) is a global initiative that aims to make information about all worldwide clinical trials involving humans publicly available. this activity was launched during the 58th wha in 2005 n following discussions and recommendations from a ministerial summit on health research in mexico city, mexico in november 2004. the ictrp is not itself a clinical trials registry, but a central repository that can be searched using the who search portal (http://apps.who.int/trialsearch/). all items in the trials registration data set are copied from individual registries onto the who central repository, and data is updated regularly. indeed, details on clinical trials come directly from one of the primary registries o in the who registry network (e.g., the european clinical trials register that became a member of the network in september 2011 p ). by consolidating clinical trials information from several worldwide sources using standardized data set format/criteria, and by implementing unambiguous identification (i.e., a universal trial number [utn] ), the ictrp not only facilitates the exchange of information, but also promotes harmonization of this information. harmonization is also further achieved because who proactively supports countries/regions in establishing who-compliant clinical trials registries or policies on trial registration. quality assurance is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. this is a major public health challenge, particularly in light of growing cross-border health issues and the growing international dimensions of trade. the quality of pharmaceuticals has been a concern of who since its inception. the development of norms, standards, and guidelines to promote quality assurance is an integral part of who's constitution, and has been endorsed and supported through numerous wha resolutions. more recently, the who medium-term strategic plan for 2008-2013 requested that the organization develop international standards, recommendations, and instruments to assure the quality of medicines, whether produced and traded nationally or internationally. n resolution wha 58.34 called on the global scientific community, international partners, the private sector, civil society, and other relevant stakeholders to "establish a voluntary platform to link clinical trials registers in order to ensure a single point of access and the unambiguous identification of trials with a view to enhancing access to information by patients, families, patient groups and others." o a primary registry in the who registry network is a clinical trial registry with at least a national remit that meets who registry criteria for content, quality and validity, accessibility, unique identification, technical capacity, and governance and administration. p the european clinical trials register provides public access to information extracted from the eu clinical trial database ("eudract"). the who medicines quality assurance program, which is part of the emp department, produces norms, standards, and guidelines on the quality assurance of pharmaceuticals. these regulatory tools are prepared through a vast global consultative process, and are ultimately approved by the who ecspp, q which meets annually. the report of each meeting (technical report series) includes newly adopted guidelines in its annexes. when adopted, the norms, standards, and guidelines become international harmonized standards intended for use by national dras, manufacturers, and other interested parties. many important international standards and projects have been developed in this area: ▸ good manufacturing practice (gmp) ▸ guidelines for regulatory approval (e.g., the guidelines on stability testing or on registration requirements to establish the interchangeability of multisource generic pharmaceutical products and the proposal to waive in vivo bioequivalence requirements) ▸ prequalification of medicines, laboratories, and supply agencies ▸ model certificates for quality assurance-related activities ▸ quality control testing ▸ new specifications for inclusion in the basic tests series and the international pharmacopoeia ▸ international chemical reference substances (icrs) r ▸ the inn program some of these international guidelines and projects are further developed below. ▸ good manufacturing practice: good manufacturing practice (gmp) is the part of quality assurance that ensures products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. gmp is aimed primarily at diminishing the risks involved in any pharmaceutical production that cannot be eliminated through testing of the final product. s gmp covers all aspects of production: from the starting materials, premises, and equipment, to the training and personal hygiene of staff. detailed, written procedures are essential for each process that could affect the quality of the finished product. panel on the international pharmacopoeia and pharmaceutical preparations. r icrs are used by laboratories to test pharmaceuticals for the purpose of quality control. these substances are mainly used for validating the results from specific tests, and as primary standards for calibrating secondary standards. who's collection of icrs is now maintained by the council of europe's european directorate for quality of medicines and healthcare (edqm) , which also distributes the substances worldwide. edqm is responsible for obtaining candidate material, testing it to ensure its purity and suitability, and reporting results with recommendations to who. s the main risks are the following: unexpected contamination of products causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; and insufficient or too much active ingredient resulting in ineffective treatment or adverse effects. recognizing the importance of gmp in international commerce of pharmaceutical products, who developed requirements early on. the first who draft text on gmp was prepared in 1967 by a group of consultants at the request of the 20th wha [40] . it was subsequently submitted to the 21st wha under the title "draft requirements for good manufacturing practice in the manufacture and quality control of medicines and pharmaceutical specialties" and was accepted. in 1968, the revised text was discussed by the who ecspp and published as an annex to its 22nd report. the text was then reproduced, with some revisions, in 1971 in the supplement to the 2nd edition of the international pharmacopoeia (ph. int.). since then, who has further defined its general principles and requirements regarding gmp [41] , and it has also established several detailed guidelines covering specific needs for gmp of active pharmaceutical ingredients [42] , pharmaceutical excipients [43] , sterile pharmaceutical products [44] , biological products [45] , blood establishments [46] , pharmaceutical products containing hazardous substances [47] , investigational pharmaceutical products for clinical trials in humans [48] , herbal medicinal products [49] , radiopharmaceutical products [50] , and water for pharmaceutical use [51] . finally, it also developed guidelines of a more general scope such as validation [52] , risk analysis [53] , technology transfer [54] , and inspection [55] , and has created appropriate training materials for countries. many countries have formulated their own requirements for gmp based on the who gmp. the international pharmacopoeia (ph. int.) comprises a collection of quality specifications for pharmaceutical substances (i.e., active ingredients and excipients) and dosage forms together with supporting general methods of analysis. it is intended to serve as source material for reference or adaptation by any who member state. clearly defined steps are followed in the development of new monographs. the ph. int. is published by who with the goal of achieving a wide global harmonization of quality specifications for selected pharmaceutical products, excipients, and dosage forms. the ph. int., or any part of it, has legal status whenever a national or regional authority expressly introduces it into appropriate legislation. the history of the ph. int. dates back to 1874 when the need to standardize terminology and to specify dosages and composition of drugs led to attempts to produce an international pharmacopoeia compendium. the first conference, called by the belgian government and held in brussels in 1902, resulted in an agreement for the unification of the formulae of potent drugs, which was ratified in 1906 by 19 countries. the outcome considerably influenced the subsequent publication of national pharmacopoeias. in 1947, the interim commission of the who took over the work on pharmacopoeias previously undertaken by the health organization of the league of nations. the 3rd wha, held in may 1950, formally approved the publication of the "pharmacopoea internationalis" and recommended, in accordance with article 23 of the who constitution, "the eventual inclusion of its provisions by the authorities responsible for the pharmacopoeias." it was thus recommended that the "pharmacopoea internationalis" not be used as a legal pharmacopoeia in any country unless adopted by the pharmacopoeial authority of that country. this first edition, published with the aim of creating a worldwide, unified pharmacopoeia, relied on collaboration with national pharmacopoeia commissions for its preparation. in 1975, the purpose of the ph. int. was reconsidered. it was decided that the publication should focus more on the needs of developing countries (because developed countries had established their own pharmacopoeias), and recommended only simple, classical chemical techniques that had been shown to be sound. since 1979, the drugs appearing in the ph. int. have therefore been selected from the list of essential drugs based on the first report of the who expert committee on the selection of essential drugs. also, whenever possible, classical procedures are used in the analytical methods so that the use of expensive equipment is minimized in the application of the ph. int. to facilitate its implementation by developing countries. the work on the ph. int. is carried out by the who ecspp in collaboration with members of the who expert advisory panel on the international pharmacopoeia and pharmaceutical preparations and other specialists [56] . the process involves consultation with, and input from, who member states and dras, who collaborating centers and national drug quality control laboratories in all six who regions, standard-setting organizations and parties including regional and national pharmacopoeias, and manufacturers around the world. in 1950, the wha adopted a resolution [57] to create the international nonproprietary names (inn) program in order to identify pharmaceutical substances unambiguously on a worldwide basis, and to provide a universal, unique, nonproprietary name to be used in pharmacopoeia monographs. it began operating in 1953 when the first list of inns for pharmaceutical substances was published. today, this program is coordinated by the who emp department. the selection of a new inn relies on a strict procedure [58, 59] . this process is supported by the expert advisory panel on the international pharmacopoeia and pharmaceutical preparations, which provides advice on proposed names following an application made by the manufacturer or inventor. the procedure also involves the who secretariat, which examines the suggested names for conformity with the general rules, similarities with published inns, and potential conflicts with existing names. after a time period for objections has lapsed, the name will obtain the status of a recommended inn and will be published as such in "who drug information" if no objection has been raised. to make inns universally available, they are formally placed by who in the public domain, hence their designation as "nonproprietary" names (also known as "generic names"). the existence of this international nomenclature for pharmaceutical substances is important for the clear identification, safe prescription, and dispensing of medicines to patients, but also for communication and exchange of information among health professionals and scientists and regulators worldwide. it provides them with a unique and universally available designated name to identify each pharmaceutical substance. today, inn names are widely used and globally recognized. at present, more than 8,000 inns have been published, and this number is growing every year. the majority of pharmaceutical substances used in medical practice are designated by an inn, and their use is already common in research and clinical documentation. nonproprietary names are intended for use in pharmacopoeias, labeling, product information, advertising and other promotional material, drug regulation and scientific literature, and as a basis for product names (e.g., for generics). also inn collaborates closely with numerous national drug nomenclature bodies. the use of inn names is normally required by national authorities and also by the european community. as a result of ongoing collaboration, national names such as british approved names (ban), dénominations communes françaises (dcf), japanese adopted names (jan), and united states adopted names (usan) are nowadays, with rare exceptions, identical to the inn. in addition to the quality standards, who also developed norms and standards for pharmacovigilance, and promotes information exchange on medicine safety. the aim is to assure the safety of medicines by ensuring reliable and timely exchange of information on drug safety issues, promoting pharmacovigilance activities on an international basis, and encouraging participation in the who program for international drug monitoring [60]. in 1968, who established its program for international drug monitoring in response to the thalidomide disaster in 1961. at the end of 2010, 134 countries were part of the who pharmacovigilance program. an international system for monitoring adverse drug reactions (adrs) using information derived from member states was established in 1971. this allows who to issue a rapid drug alert whenever a serious problem in the safety of any medicinal product arises. who headquarters in geneva is responsible for policy issues, while the operational responsibility for the program rests with the who collaborating centre for international drug monitoring, uppsala monitoring centre in sweden. a common reporting form was developed, agreedupon guidelines for entering information were formulated, common terminologies and classifications were prepared, and compatible systems for transmitting, storing and retrieving, and disseminating data were created. the adrs database in uppsala currently contains over three million reports of suspected adrs. in 2003, a who advisory committee on safety of medicinal products (acsomp) was established to guide who on general and specific issues related to pharmacovigilance. additionally, a network of "information officers" was established in 1980 to allow a direct relationship between who and all national dras in member states. each national information officer is charged with providing information to who on the safety and efficacy of pharmaceutical preparations, and with securing prompt transmission to national health authorities regarding new information on serious adverse effects. this certification scheme was initially adopted by the 22nd wha in 1969 [61], but since then it has been amended. it is an administrative instrument that requires each participating member state, upon application by a commercially interested party, to attest to the competent authority of another participating member state whereby: ▸ a specific product is authorized for placement on the market within its jurisdiction, or if it is not authorized, the reason why that authorization has not been accorded. ▸ the manufacturing plant in which it is produced is subject to inspections at suitable intervals to establish that the manufacturer conforms to gmp as recommended by who. ▸ all submitted product information, including labeling, is currently authorized in the certifying country. the primary document delivered under this scheme is the certificate of pharmaceutical product (cpp), but two other documents can be requested within the scope of the scheme. the first is a statement of licensing status of pharmaceutical product(s), and the second is a batch certificate of a pharmaceutical product (this document is rarely applied other than to vaccines, sera, and biologicals). these documents are used by dras of importing countries in their decision to approve, renew, extend, or vary a license. who created models for these confidential documents and listed the information that such certificates need to include. obligations that certifying authorities need to fulfill in order to be able to deliver a certificate have also been defined [62]: ▸ possess an effective national licensing system, not only for pharmaceutical products, but also for responsible manufacturers and distributors. ▸ have gmp requirements, in agreement with those recommended by who, to which all manufacturers of finished pharmaceutical products are required to conform. ▸ effective controls must be in place to monitor the quality of pharmaceutical products registered or manufactured within its country, including access to an independent quality control laboratory. ▸ have a national pharmaceuticals inspectorate, operating as an arm of the national dra, and having the technical competence, experience, and resources to assess whether gmp and other controls are being effectively implemented, and the legal power to conduct appropriate investigations to ensure that manufacturers conform to these requirements by, for example, examining premises and records and taking samples. ▸ support administrative capacity to issue the required certificates, to institute inquiries in the case of complaint, and to notify expeditiously both who and the competent authority in any member state known to have imported a specific product that is subsequently associated with a potentially serious quality defect or other hazard. gmp standards provide the basis for the who certification scheme that relies on the capacity, experience, and expertise of the certifying authority of the exporting country. this scheme is a great example of cooperation between countries and is an important tool to support a regulatory system in developing countries that do not have enough capacity, resources, or expertise. biological medicinal products, such as vaccines, blood and blood products, diagnostics, gene therapy, biotechnology products, cytokines and growth factors, and cell and tissue products, rely heavily on international standardization to ensure their quality and their equivalence across manufacturers. this is especially true due to the increasing globalization in the production and distribution of these biological medicines. over the past 50 years, who has worked to standardize these biological materials by establishing international biological reference materials t as well as developing international guidelines and recommendations on the production and control of biological products and technologies. guidelines provide more general information on a range of topics of interest to national dras and manufacturers (e.g., "guidelines on evaluation of similar biotherapeutic products, sbps"), whereas recommendations establish the technical specifications for manufacturing and quality control of specific products (e.g., "recommendations to assure the quality, safety and efficacy of bcg vaccines"). who has also released many other documents on general topics (such as "regulation and licensing of biological products in countries with newly developing regulatory authorities" [63] and "good manufacturing practices for biological products" [64]) or on a specific type of product (e.g., blood products and related biologicals, cells and tissues, cytokines, or vaccines) to facilitate control of these biological products on a worldwide basis. these norms and standards have been developed to assist who member states in ensuring the quality and safety of biological medicines and related in vitro biological diagnostic tests worldwide. by adopting these guidance documents in their pharmacopoeias or equivalent legislation, each country ensures that the products produced and used in their country conform to current international standards. by advising national dras and manufacturers on the control of biological products, regulatory guidance documents also establish a harmonized regulatory framework for products in international markets. who accomplishes its biological program through the who collaborating centers and the who ecbs. members of the ecbs are scientists from national control agencies, academia, research institutes, public health bodies, and the pharmaceutical industry acting as individual experts and not as representatives of their respective organizations or employers. its work is based on scientific consensus achieved through this international consultation and collaboration. this committee, which directly reports to the executive board, has met on an annual additionally, who has been particularly active in the specific field of blood products and related biologicals. it has provided technical guidance and quality assurance tools to dras, national control laboratories, and manufacturers to support implementation of quality and safety systems for the production and control of blood products and related in vitro diagnostic devices worldwide. indeed, many countries have significant difficulties in fulfilling their responsibilities in this field because processing blood (with inherent variability due to the nature of the source materials) is a highly specialized process that requires a high degree of expertise. this development of who international reference materials and guidelines supports the technical capacity of national dras and assures the compliance of manufacturers to quality and safety measures globally in order to prevent transmission of diseases via blood products. it also contributes to technology transfer, global cooperation, and harmonization of regulations via the blood regulators network (brn). finally, the who has been very involved in the development of standards and guidelines regarding vaccines due to the importance of these products in public health. v moreover, who established the "prequalification of vaccines" (regarding the acceptability, in principle, of vaccines from different sources for supply) to help the united nations children's fund (unicef) and other un agencies that purchase vaccines. finally, through its regulatory pathways initiative it also helps to address the challenges faced by developing countries that are targets for clinical trials or introduction of new vaccines not registered in the country of manufacture. the objective is to support the establishment of regulatory mechanisms for the licensing of products in those countries that have not yet fully developed the expertise for the review of technical applications. this is achieved via workshops and technical assistance in collaboration with the european medicines agency (ema) through its article 58 scientific opinion procedure, w the us fda, and other national dras in developed countries. a developing countries' vaccine regulators network (dcvrn) was created in september 2004, and regional initiatives were also established. in many countries (developed and undeveloped), there is recognition of the significant need for research and development of medicines specifically for pediatric use (or data from pediatric studies using medicines that have been developed for adults). this lack of pediatric data became an important problem despite many initiatives from different regions or countries. the lack of suitable pediatric medicines, paired with inconsistent regulatory frameworks, poses significant risks to a particularly vulnerable patient population. the overall aim of the pmrn x is to promote availability of quality medicines (including biological medicines and vaccines) for children by facilitating communication, collaboration, and regulatory harmonization across manufacturing, licensing, and research [66] . more specifically, among several objectives, this network tries to: ▸ provide a forum for discussion between worldwide dras to build awareness of pediatric medicines regulatory considerations ▸ facilitate the collaboration, discussion, and work towards consensus on regulatory standards for pediatric medicines (i.e., the development of international recommendations and common standards for clinical trials and registration of medicines for children based on the existing ich, ema, and us fda guidelines) ▸ strengthen licensing (approval) systems for pediatric medicines by increasing regulatory cooperation, information sharing, and training traditional medicines y have been used in many countries throughout the world over many centuries. today, these medicines still represent an important part of healthcare in some countries. z for example, more than 100 countries have regulations for herbal medicines, but practices of traditional medicine vary greatly from country to country and from region to region, as they are influenced by factors such as culture, history, personal attitudes, and philosophy. however, while it is often necessary to tailor legislation and delivery to reflect the needs and traditions of the individual countries, a number of themes and issues are common, such as the importance of practitioner training, the issues related to safety, the need to enhance research into both products and practices, and the importance of labeling. also, the use of traditional medicines has expanded globally and has gained popularity in the last few decades. specifically, these practices have not only continued to be used for primary healthcare of the poor in developing countries, but have also been used in other countries where conventional medicines are predominant in the national healthcare system. aa with this tremendous expansion in the use of traditional medicines worldwide, safety and efficacy as well as quality control of herbal medicines and traditional procedure-based therapies have become important concerns for many of these countries. for this reason, who has been increasingly involved in developing international standards and technical guidelines for these types of medicines, and also in increasing communication and cooperation between countries [67] . the challenge now is to ensure that traditional medicines are used properly, and to determine how research and the evaluation of traditional medicines should be carried out. supported by several wha and executive board resolutions, who has developed and issued a series of technical guidelines (e.g., guidelines for the assessment of herbal medicines, research guidelines for evaluating the safety and efficacy of herbal medicines, and guidelines for clinical acupuncture research). in 1997, who developed draft guidelines for "methodology on research and evaluation of traditional medicine" that was finally approved in april 2000 [68] . the purpose of this document is to promote the proper development, registration, and use of traditional medicines and to harmonize the use of certain terms in traditional medicine. moreover, in 2006, who established a global network (called the international regulatory cooperation for herbal medicines [irch]) to allow communication and exchange between worldwide regulatory authorities responsible for the regulation of herbal medicines. the mission of this program is "to make quality priority medicines available for the benefit of those in need." this is achieved through evaluation and inspection activities, and in cooperation with national dras and partner organizations. the list of prequalified medicinal products (updated regularly) is used principally by un agencies (including unicef and the joint united nations programme on hiv/aids [unaids]) to guide their procurement decisions. but, the list has also become a vital tool for any agency or organization involved in bulk purchasing of medicines, as demonstrated by the global fund to fight aids, tuberculosis and malaria. the strategy is to apply unified standards of acceptable quality, safety, and efficacy and to build the capacity of staff from national dras, quality control laboratories, and from manufacturers or other private companies, to ensure quality medicines. technical assistance, training, and capacity building are an important part of the program [70] . when a product is included on the who list, the relevant product dossier has been evaluated and the manufacturing sites inspected by who-appointed assessors and inspectors and found to comply with who standards. who also recognizes the evaluation of products by some major dras that apply stringent standards for quality, including, but not limited to, the us fda, ema, and health canada. bb however, it is important to note that the inclusion of a product (or a laboratory) on this list does not imply any approval by who because it is the sole prerogative of national authorities. who inspections are done by a team of inspectors, including: ▸ an inspector/expert from one of the pharmaceutical inspection co-operation scheme (pic/s) countries ▸ a who representative (inspector/expert) ▸ an inspector (or inspectors) as an observer from the national dra of the country in which the laboratory is located at the end of 2011, the who list of prequalified medicines included 269 products (manufactured in 25 countries); a total of 23 quality control laboratories had been prequalified (covering all who 6 regions). the program had also prequalified its first active pharmaceutical ingredients (apis) [71]. the above projects are specifically related to the harmonization of pharmaceutical regulations and regulatory standards related to medicinal products. however, it is important to note that several other who projects not directly related to the harmonization of pharmaceutical bb when a product is listed with a reference to us fda or ema, the alternative listing procedure was used, and the products have been added to the list relying on the assessment and inspections conducted by the us fda or ema. regulations cc have been or are also very important because they facilitate implementation of common systems, agreements on terminology, and the establishment of a forum for exchange of not only information, but also expertise and experience. these other who projects ultimately facilitate overall dialogue, cooperation, convergence, and harmonization between countries and regions. moreover, other more general projects can also promote regional and subregional collaboration and harmonization of the regulation. for example, one of the principles of the general ec-acp-who partnership established in 2004 dd was to "strengthen existing collaborative arrangements (e.g. pooled procurement in the caribbean) and catalyse the creation of new ones, which can work together to achieve pooled procurement, common policies and harmonization of legislation." in addition, who publishes many documents regarding pharmaceuticals and regulations (i.e., newsletters, periodicals, reports status, or special publications such as the who blue book [72] ) that allow the diffusion and exchange of information and data everywhere in the world. for example, "who drug information" is a quarterly journal, launched in 1987, which provides an overview of topics relating to medicine development and regulation that is targeted to a wide audience of health professionals and policymakers. it communicates the latest international news and trends. finally, some other specific who projects are also very important in facilitating the implementation of the international standards. these following projects need to be reviewed even though they are not directly related to the harmonization of pharmaceutical regulations because they demonstrate the key role of who in the global regulatory system, and therefore show how this organization has the legitimacy to further coordinate global harmonization. ▸ who review of drug regulatory systems: to ensure that public health is appropriately supported, national regulatory capacity needs to be regularly assessed, areas of weakness need to be identified, and necessary measures need to be taken. the objectives of this review are to strengthen national regulatory and control capacity through the identification of specific needs and the provision of appropriate technical support and training. this is done via the evaluation of existing legal framework, regulations, and control activities in order to assess the national regulatory capacity against a set of predefined parameters. who can then provide technical input if gaps are identified. this activity is very important, especially in developing countries, to ensure that international standards can be appropriately implemented at the national level. it is also an important tool to have a clear status of national regulatory systems to evaluate appropriate needs from developing countries and therefore necessary support from regional and international organizations. the who multicountry study (involving only 10 countries) also showed that such assessments represent significant opportunities to learn more about the strengths and weaknesses of dras and the different strategies used to improve drug regulation performance [75] . the international health regulations (ihr), first adopted by the health assembly in 1969 and then significantly revised in 2005 in consideration of the growth in international travel and trade and the emergence or reemergence of international disease threats and other public health risks [76] , were finally adopted by the 58th wha on may 23, 2005 and entered into force on june 15, 2007. the ihr is an international legal instrument that is binding on all the who member states. these global rules were developed and implemented to enhance national, regional, and global public health security. its aim is to help the international community prevent and respond to acute public health risks that have the potential to cross borders and threaten people worldwide. the stated purpose and scope of the ihr are "to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade." the ihr has been used for the h1n1 pandemic crisis [77] . the revised ihr requires countries to strengthen their core surveillance and response capacities so that they can report certain disease outbreaks and public health events to who. building on the unique experience of who in global disease surveillance, alert, and response, the ihr defines the rights and obligations of countries to report public health events, and establishes a number of procedures that who must follow in its work to uphold global public health security. as mentioned above, this document was not specifically developed for pharmaceutical products, but is an important global tool that enhances cooperation between all countries in the world. indeed, even if this agreement does not specifically relate to the harmonization of pharmaceutical regulations, it is very interesting for many reasons. first, this project helps strengthen worldwide capacities for public health and global cooperation in general, which is important for the implementation of harmonized global standards. more importantly, this is one of the first agreements that manages public health as a truly global issue and proposes further action using an integrated international approach and network. it shows that further integrated global cooperation in the area of health (with who being at the center of this cooperation to coordinate this effort) is possible and beneficial [78]. the mission of who's program on medicines and pharmaceutical policies is to support the achievement of the health-related mdgs by assisting governments and organizations to ensure global and equitable access to safe, effective medicines of assured quality. goal 8 ee and target 8e ff are particularly applicable to who harmonization activities in the pharmaceutical domain. many of who's activities in the pharmaceutical domain support the achievement of these mdgs because they globalize the resolution of major public health issues (that cannot be resolved at the national/local level), they promote collaboration between countries and regions, and they provide tools and standards to allow such international collaboration. since its creation, who has indeed played a significant role in the global harmonization of pharmaceutical regulations. as per its mandate and the responsibilities defined in its constitution, it has developed and maintained numerous international standards, norms, guidelines, classifications, and nomenclatures through a rigorous, international, and independent scientific consultative process. in addition to this normative role, who has also established important networks to facilitate global cooperation. for example, icdras has been an important player in global regulatory harmonization. it launched many projects that have facilitated and promoted harmonization and cooperation between countries [79]. cooperation projects have also been pioneered over the years with a specific interest in essential medicines. gg the who prequalification program has been an important step since it demonstrated that cooperation in the domain of medicine evaluation is possible and beneficial. indeed, this program has been very positive and its scope has continually been extended since its creation in 2001. it has clearly accelerated the access of essential medicines worldwide (especially in low and middle income countries) [80] . this model should be used to further develop regional and global collaboration for medicine evaluation. the example of the 2010/2011 pilot who/east african community (eac) collaborative procedure initiated to facilitate registration of prequalified medicines in the eac [81] was positive. the overall aim was to identify a framework for who/eac, for joint evaluation and approval of dossiers and inspections of medicine manufacturing sites, and to ensure that these assessments are integrated into national regulatory decision making. two assessors each from three eac countries (kenya, tanzania, and uganda) and six who assessors jointly assessed two product dossiers submitted by a single manufacturer. the dossiers were submitted in parallel, and with identical content, to each participating eac country and to who. the products were both prequalified. the principal benefit of this joint assessment was that once the products had been jointly assessed and approved by who/eac, they were granted immediate access to the markets of each of the countries that had participated in the joint assessment. also, such joint assessment contributes to harmonization of regulatory requirements at the regional level. this pilot who/eac project also exemplifies the role of who in providing technical assistance to countries and supporting local capacity building. indeed, by acknowledging the important role of adequate systems to implement sound and effective pharmaceutical regulation, who has supported developing countries in addressing their deficiencies or capacity problems through various types of training, assessment of regulatory capacity, and the recommendation of institutional development plans. these activities have been very beneficial in the past, but work needs to continue and grow in this domain, as problems still exist. indeed, the extent of implementation of standards varies from one region to another. there are a number of factors that explain observed weaknesses of medicine regulation, and these differ from country to country and depend also on the individual health systems. countries may vary regarding their registration system, and not all of them can implement a comprehensive medicine evaluation and registration system. also, who encourages regional and international collaboration among national dras in order to promote the harmonization of requirements and practices, and to strengthen professional competence [82] . however, as recognized in its medicine strategy plan, cooperation with regional harmonization initiatives and organizations should be further enhanced [83] . closer cooperation and coordination should also be sought with other global initiatives such as ich. further assistance to countries and cooperation with other regional and global initiatives are indeed possible and can be facilitated by who's regionalized structure. this specific threelevel organization provides multiple opportunities for engaging with countries. the headquarters focus on initiation, development, and global coordination of harmonization projects, while regional offices focus on technical support and building national capacities to support implementation. who's presence in countries also allows a close relationship with ministries of health and its partners inside and outside of government. this work at the regional and country levels is critical in ensuring that local and regional needs and challenges are taken into consideration when international standards and projects are developed. to conclude, although some improvements may address current challenges, who has been very successful and beneficial for all member states (developing and also developed countries). it has promoted evidence-based debate, analysis, and recommendations for health through its own work and that of the numerous formal and informal networks and collaborating centers around the world. these networks facilitate lively cooperation between scientists across nations and allow governments to jointly tackle global health problems. development and promotion of global norms and standards in medicine is one of who's efforts that is widely perceived as being in an area in which who has a comparative advantage. this advantage is due to the recognition of who as the global leader and coordinating authority on global public health. the achievement of the mdgs and the renewal of primary healthcare are indeed unthinkable without who's norms and standards, policy guidelines, and technical cooperation. this is why the development and promotion of global norms and standards are an area of continued focus for who [84] . it is indeed critical that who continue its work towards better harmonization and cooperation in the pharmaceutical domain. acknowledging the unique neutral and independent role of who, its numerous successes in the past, and its nearly universal membership, it would be appropriate to further extend the leadership of who in this domain. this increased responsibility in the coordination of medicines would also further fulfill its mandate "to act as the directing and co-ordinating authority on international health work." [85] the international conference on harmonization of technical requirements for registration of pharmaceuticals for human use (ich) is a 20-year-old program. this unique initiative was established with the objective to bring together the dras of europe, japan, and the united states and experts from the pharmaceutical industry in these three regions to discuss scientific and technical aspects of pharmaceutical product registration. the drug regulatory systems in all three regions share the same fundamental concerns for the safety, efficacy, and quality of medicines. however, many time-consuming and expensive experiments have been repeated in all three regions to meet specific regional requirements. the goal of ich has been to increase harmonization of technical requirements to ensure that safe, effective, and high-quality medicines are developed and registered in the most efficient and cost-effective manner in order to be delivered to the maximum number of patients in the world without delay. these activities have been undertaken to promote public health, prevent unnecessary duplication of clinical trials in humans, and minimize the use of animal testing without compromising safety and effectiveness. by making recommendations on ways to achieve greater harmonization of technical requirements for product registration, the objective is indeed to reduce or obviate the need to duplicate the testing carried out during the research and development of a new product. since its inception in 1990, ich has evolved, through its global cooperation group (gcg), to respond to the increasingly global face of drug development, so that the benefits of international harmonization for better global health can be realized worldwide. this ich mission is embodied in its current terms of reference: ▸ to maintain a forum for a constructive dialogue between regulatory authorities and the pharmaceutical industry on the real and perceived differences in the technical requirements for product registration in the eu, us, and japan in order to ensure a more timely introduction of new medicinal products, and their availability to patients; ▸ to contribute to the protection of public health from an international perspective (added upon revision in 2000); ▸ to monitor and update harmonized technical requirements leading to a greater mutual acceptance of research and development data; ▸ to avoid divergent future requirements through harmonization of selected topics needed as a result of therapeutic advances and the development of new technologies for the production of medicinal products; ▸ to facilitate the adoption of new or improved technical research and development approaches which update or replace current practices, where these permit a more economical use of human, animal, and material resources, without compromising safety; ▸ to facilitate the dissemination and communication of information on harmonized guidelines and their use such as to encourage the implementation and integration of common standards. ich is comprised of representatives from six parties (the founding members of ich) that represent the regulatory bodies and research-based industry in the eu, japan, and the us: since 1990, when ich was initiated, members have been added: ▸ the international federation of pharmaceutical manufacturers & associations (ifpma), the global nonprofit, nongovernmental organization, founded in 1968 to represent the research-based pharmaceutical, biotech, and vaccine sectors. its members are comprised of over 20 leading international companies and over 40 national and regional industry associations covering both developed and developing countries. ifpma is very involved in all subjects related to the improvement of global health. it has been closely associated with ich since its inception to ensure contact with the research-based industry (especially outside the ich regions). ifpma provides the ich secretariat. this important group of nonvoting members was established as a link between ich and non-ich countries and regions. the ich organization consists of the ich steering committee, ich coordinators, ich secretariat, and ich working groups. the ich global cooperation group (gcg) and the ich medical dictionary for regulatory activities (meddra) management board are subcommittees of the ich steering committee. the steering committee is the body that governs the ich, determines the policies and procedures, selects topics for harmonization, and monitors the progress of harmonization initiatives. this committee, established at the first ich meeting in april 1990, has met at least twice a year since, with the location rotating between three regions (eu, japan, and us). during these committee meetings, new topics are considered for adoption, reports are received on the progress of existing topics, and maintenance and implementation of the guidelines are discussed. each of the six ich parties has two seats on the ich steering committee. each of the observers nominates nonvoting participants to attend the ich steering committee meetings. ifpma also participates as a nonvoting member. meetings of the ich meddra management board, ich gcg, and the regulators forum also occur during the same week as the steering committee meeting. ich working groups are the key players of the ich harmonization process. they are responsible for the development, implementation, or maintenance of ich guidelines. each of the six ich parties is represented in every working group. the official membership of an expert working group/implementation working group (ewg/iwg) is usually limited to two officials per party (one topic leader and one deputy topic leader). one of these topic leaders is nominated rapporteur (and sometimes a second is nominated co-rapporteur) by the steering committee. ich observers and interested parties hh can also nominate one representative. the pharmacopoeial authorities and representatives from the self-medication industry and the generic industry were invited to participate in the various working groups. finally, the three regulatory parties of the steering committee officially designate a regulatory chair when a new ich topic is formally adopted. the regulatory chair, designated among the three regulatory parties, regularly presents reports to the steering committee and ensures, in close collaboration with the rapporteur, timely execution of the ich process and adherence to the concept paper and business plan, including scope and timelines. depending on the type of harmonization activity required, the steering committee will endorse the establishment of one of three types of working groups: ▸ expert working group (ewg): these working groups are appointed by the steering committee when new topics are accepted for harmonization. the objective of each ewg is to review the differences in requirements between the three regions and develop scientific consensus required to reconcile those differences. it is charged with developing a harmonized guideline that meets the objectives defined in the concept paper and business plan. ▸ implementation working group (iwg): an iwg's task is to develop questions and answers (q&a) to facilitate implementation of existing guidelines. ▸ informal ewg/iwg: these working groups are formed prior to any official ich harmonization activity. their objective is to develop a concept paper and business plan. working groups meet in the same week as the steering committee and report on their progress to the committee. these one-week meetings are key for the ich organization as they allow for a regular review of efforts and achievements and adjust them if necessary. ich discussion groups are established to discuss specific scientific considerations or views (e.g., gene therapy discussion group) to facilitate the exchange of information on a specific topic, and ultimately the harmonization of the requirements. the coordinators are fundamental to the smooth running of the ich and are nominated by each of the six parties. an ich coordinator acts as the main contact with the ich secretariat and ensures that ich documents are distributed to the appropriate persons within the area of their responsibility. each party has also established a contact network of experts within their own organization or region in order to ensure that, in the discussions, they reflect the views and policies of the cosponsor they represent. the way this network operates differs according to the administrative structure of the party concerned. due to structural differences within the eu and mhlw, ich technical coordinators are also designated from the ema and pmda, respectively. they support the ich coordinator and facilitate every action of the steering committee members in the region, mainly by applying their scientific knowledge. their roles include acting as a contact point between the experts within the ema and pmda and the ich coordinator at the main regulatory body, and as a contact point with the ich secretariat. the ich secretariat operates from the ifpma offices in geneva (switzerland), and provides support to the ich steering committee. the secretariat is primarily concerned with preparations for, and documentation of, meetings of the steering committee, as well as coordination of preparations for working group (ewg, iwg, and informal wg) and discussion group meetings. the secretariat also provides administrative support for the gcg and the meddra management board, and maintains the ich website. the meddra management board, appointed by the ich steering committee, has overall responsibility for direction of meddra, an ich standardized dictionary of medical terminology. the board oversees the activities of the meddra maintenance and support services organization (msso), which serves as the repository, maintainer, developer, and distributor of med-dra. the management board is composed of the six ich parties, the medicines and healthcare products regulatory agency (mhra) of the uk, health canada, and who (as observer). the ifpma acts as a nonvoting observer on the management board and also chairs the board. as stated in its mission statement adopted by all parties in may 2005, this group "promotes a mutual understanding of regional harmonization initiatives in order to facilitate the harmonization process related to ich guidelines regionally and globally, and to facilitate the capacity of drug regulatory authorities and industry to utilize them." this group ensures that the benefits of ich harmonization extend beyond the three ich regions (japan, eu, and us). the role of the gcg has changed over time as the focus on collaboration with the non-ich regions increased. from its creation to today, three phases can be differentiated: ▸ first phase (1999 to 2003 : information sharing outside ich: during these first three years, the gcg mandate was to share information outside ich (via preparation of brochures, presentations at international meetings, etc.). the objectives were to make available to any country or pharmaceutical company that requested it information on ich, ich activities, and ich guidelines. to this end, the group created a series of brochures intended to guide its activities as it answers requests for information and responds to non-ich regulators and industry: • ▸ second phase (2003 phase ( to 2007 : integration and collaboration with rhis: on november 9, 2003, the ich gcg released their terms of reference in which they extended their action to act as the primary representative of the ich steering committee outside the ich regions, and equally as such as a conduit for non-ich parties to the ich steering committee. to do so, the group developed a privileged relationship with other non-ich harmonization initiatives. this key activity of the gcg had three advantages: • to share ich discussions and actions with the non-ich regions (allowing, when possible, harmonization and implementation of ich activities on a worldwide basis) • to promote and organize the involvement of the non-ich regions experts in ich discussions (via expert meetings, comments on step 2 guidelines, and training on guidelines) • to facilitate interregional collaboration in order to promote transparency, better understanding of challenges and potential solutions to harmonization issues, leverage collective experience and knowledge (allowing easier standardization and development of good harmonization practice) when, in 2003, the gcg decided to include representatives from the non-ich regions, the relationship with the non-ich regions became more collaborative and proactive, and the focus shifted from information sharing to a two-way dialogue to set up training and work on implementation. the results of these collaborations allowed the organization of workshops in the regions (e.g., apec workshops on clinical research inspections in 2008 and 2009 in thailand, the sadc quality guideline workshop in 2008 in zambia, and the apec quality guideline workshop in 2008 in china). as an example, the gcg also endorsed the apec life sciences innovation forum (lsif) sponsored workshop on ich quality guidelines (q8, q9 and q10), held in september 2007 in seoul, south korea. this workshop was a great success for the spread of ich concepts and recommendations in this region as it was attended by more than 400 participants (i.e., regulators, policymakers, academia, and industry) from 17 countries. this type of workshop allows for practical explanation of ich guidelines, but also opens up discussion and exchange on the anticipated challenges and opportunities associated with the implementation of ich guidelines in order to better prepare implementation. the participation of these individual countries is distinct and complementary to the participation of official rhi representatives. in june 2008, the inaugural meeting of the expanded gcg occurred. today, the key focus of the gcg continues to be the implementation of ich guidelines via the organization of training that began in 2007. this training is indeed an important means for the promotion of better understanding of ich and ich guidelines beyond the ich regions. it developed a framework and mechanism for policy [91-2], a procedure for selection and prioritization, a template for training requests, definitions of roles and responsibilities for the organization and coordination of training activities, and a clearinghouse of training events for public access. these training activities (most of the time coordinated with the respective rhis) involve ich experts. during the meeting in october 2007 in yokohama, japan, the ich steering committee also decided to complement the gcg with the regulators forum. the ich regulators forum is the latest idea implemented by ich to increase communications and sow relationships between worldwide dras in order to ensure adoption and implementation of ich guidelines. following a proposal from the us fda in 2007, the first meeting occurred in portland, oregon, us in june 2008. this is a good complement to the gcg activities and includes authorities from the three ich regions, the observers, the rhis, and individual dras such as australia, brazil, china, chinese taipei, india, korea, russia, and singapore. this ich regulators forum allows frank discussion and the sharing of expertise among dras regarding best practices and challenges related to the implementation of ich guidelines and their impact on regulatory systems. this discussion assists in identifying training and capacity needs for action by the gcg. more importantly, it also builds mutual understanding, relationships, and trust. in the 1980s, many varied efforts of harmonization of pharmaceutical regulatory requirements were conducted. first, the european community, who was developing a single market for pharmaceuticals, had shown that harmonization among different countries (with different medical cultures/practices and regulatory systems) was possible. at the same time, bilateral discussions between europe, japan, and the us on the possibility for harmonization were ongoing. the concretization of these ad hoc discussions happened during the world health organization (who) international conference of drug regulatory authorities (icdras) in paris in 1989, where specific plans were agreed to. following this meeting, the three authorities approached ifpma to discuss a joint regulatory-industry initiative on international harmonization. the spirit and concept of ich was then agreed on between the different parties. in april 1990, ich was officially created at its inaugural steering committee meeting, hosted by the efpia in brussels, belgium. representatives of the regulatory agencies and industry associations of europe, japan, and the us met primarily to plan an international conference, but at the meeting the wider implications and terms of reference of ich were also discussed. during this first meeting, the structure (including a steering committee and expert working groups) and the focus of ich activities (harmonization of safety, efficacy, and quality guidelines for human drugs and biological products) were agreed on. eleven topics were selected for discussion at the first conference. finally, it was agreed to expand the membership of the steering committee to include representatives from who, efta, and canada as observers because the harmonized guidelines could be useful to other non-ich regions. additionally, agreement was reached on the full name of ich. this name was chosen because one of the objectives of this group was to organize international conferences on harmonization. today, this name is associated with the overall initiative. the ich members officially confirmed their commitment to ich in a statement following the 2nd steering committee meeting: the parties cosponsoring this conference, represented at the 2nd steering committee meeting in tokyo, 23-24 october 1990 re-affirmed their commitment to increased international harmonization, aimed at ensuring that good quality, safe, and effective medicines are developed and registered in the most efficient and cost-effective manner. these activities are pursued in the interest of the consumer and public health, to prevent unnecessary duplication of clinical trials in humans and to minimise the use of animal testing without compromising the regulatory obligations of safety and effectiveness. this conference will provide a unique opportunity for regulators and industry to reach consensus on the steps needed to achieve this objective through greater harmonization of technical requirements and to set out practical and realistic targets for harmonising requirements where significant obstacles to drug development and the regulatory process have been identified. recognising the substantial progress which has already been made in achieving harmonization within europe and through bilateral contacts between europe, japan, us, and other regions, the conference will seek to make further progress through a trilateral approach, with clearly defined priorities, methods of work and recommendations to both industry and regulatory authorities. whilst the conference will be an important step forward, it is not seen as an end in itself, but as a stage in a developing process, at a high level, between regulators and industry. the conference, its preparations, and follow-up activities will be conducted in an open and transparent manner and the presence of observers from other regulatory authorities and who is welcomed as a means of ensuring that the benefits of progress towards harmonization can be utilized world-wide. the conference will not only look at existing issues but will, based on past experience, seek to minimise future divergence of new registration requirements, as a consequence of technical progress. this initial ich statement is important because it provides the spirit of ich that has been followed and implemented in all subsequent ich activities since. from its creation in 1990 to 2000, the initial focus of ich was to promote technical and scientific exchanges and discussions in order to find consensus on divergent technical requirements for registration of medicinal products in the ich regions. the goal was indeed to remove redundancy and duplication in the development and review process, such that a single data set could be generated to demonstrate the quality, safety, and efficacy of new products. during this first phase of its activities, the ich structure and process were defined, a lot of harmonization activities started, and several guidelines/standards developed. these first harmonization discussions were directed to both technical scientific content (related to quality, safety, or efficacy topics) and to format and communication tools (development of e3 and the start of meddra, electronic standards for transmission of regulatory information (estri) and common technical document (ctd) projects). during these first 10 years, there was a growing interest in ich products beyond ich countries, and ich recognized early that harmonization within the ich regions would not suffice. however, during these first years, discussions and activities focused mainly on harmonization among ich parties (even though ich agreed to include observers as a link to the non-ich regions) because it was important to start the process with a limited number of committed parties. in november 2000, the 5th international conference on harmonization (ich5) in san diego, california, us marked the end of the first 10 years of ich activity. this conference provided an opportunity to evaluate results and to identify future needs in the area of international harmonization. at the conference, results were presented of a survey on utilization of ich guidelines confirming the positive contribution of ich in improving the international drug regulatory approval process, thus speeding the availability of new medicines to the public. in its statement titled "the future of ich" released at ich5, the steering committee emphasized its intentions to focus the second phase of ich on implementing and maintaining existing guidelines, preventing disharmony, encouraging scientific dialogue and harmonization in new areas, and undertaking efforts towards global cooperation with non-ich regions and countries. during its second phase, ich continues to develop and implement tripartite guidance on specific technical requirements, and also increase its effort on the implementation of harmonized regulatory communication tools (i.e. meddra, ctd, estri, etc.) between authorities and industry. indeed, one of the areas of focus of this second phase is to ensure adequate implementation and maintenance of all the guidelines developed since 1990. today, new guidelines continue to be developed, but less frequently. these new guidelines cover important technical subjects related to pharmacovigilance (i.e., guidelines e2d, e2e, and e2f) or improvement of quality systems (i.e., guidelines q8, q9, and q10). new emerging topics (such as gene therapy) have also been discussed. however, the main challenge of ich is now to maintain and update the collection of guidelines already developed (i.e., follow the evolution of science, the experience gained, etc.). the second focus and priority of this ich phase has been, and continues to be, the extension of relationships with non-ich regions. it began with the creation of the gcg as a subcommittee of the ich steering committee in 1999. since this time, ich has developed its relationship with non-ich regions and tried to facilitate the implementation of its standards and guidelines on a broader territory via collaboration and training. even if some relationships existed before, the gcg has been key for this geographical extension, and its role increased over time by moving from information sharing (via preparation of brochures, presentations at international meetings, etc.) to a collaborative and proactive dialogue (via the incorporation of non-ich regions and countries in the group). further evolution of the ich structure and the gcg's terms of reference are expected to continue to promote greater involvement of global regulators [92-1,92-2]. the first activity of ich was to organize the ich1 conference in 1991, one year after its creation, in order to exchange points of view and discuss divergences among different parties involved. since ich1, five additional conferences have been organized (table 1) . these regular, well-attended conferences helped communicate the results of the harmonization activities to the largest possible audience. they were designed as an open forum (in breakout sessions) to gather additional public comments and provide updates on ich's scientific activities. these six conferences were well attended (e.g., 2,400 participants representing industry and authorities of over 40 countries for ich3 and 1,300 participants representing industry and authorities of over 140 countries for ich5). the early ich conferences were very important in increasing visibility on the process of harmonization and for ensuring that the process was carried out in a transparent manner. ich5 focused primarily on the finalization and completion of the ctd guideline. the last ich conference organized, ich6, focused on areas such as new technologies and global cooperation with regulatory harmonization initiatives outside the ich regions. the three satellite sessions (related to "partnerships in harmonization," "gene therapy," and "meddra users' group") also confirmed the priorities of the meeting. during this conference, opportunities and new challenges for regulatory harmonization were discussed. the practical implementation of the ctd was also reviewed. after ich6, no additional international conferences were scheduled. ich7 was planned to have taken place in europe in 2007, but it was then canceled. instead, in may 2007, the ich steering committee decided to replace these large international ich conferences with smaller and more frequent regional public meetings at the time of the ich steering committee meetings in the region (in order to benefit from the presence of steering committee members and ich experts). now that the ich process is well recognized, these smaller regional meetings allow for a better focus on regional issues and challenges. it also provides everyone the opportunity to meet with regulators and industry experts involved in ich activities, to be regularly informed on recent developments, and to exchange information on different hot topics. following this decision, regional meetings have been organized: ▸ in europe, the first eu regional public meeting took place in brussels, belgium in november 2008. ▸ in north america, the first regional public meeting took place in washington, dc, us in october 2008. ▸ in asia, the first regional public meeting took place in tokyo, japan in november 2007. the ich process was first drawn up at the steering committee meeting in washington, dc in march 1992, and amended in tokyo, japan in september 1992. since then, the ich procedures have been revised several times . moreover, the new principles of governance, agreed to at the ich steering committee meeting in june 2012, have revised the role of regulator and suggestions for new harmonization initiatives may arise in a number of forums (ich regional guideline workshops; regional and international conferences, workshops, and symposia dealing with research and development (r&d) and regulatory affairs; recognized associations; testing and registration of medicines, etc.). from the suggestion of a new harmonization action to the development of a new guideline (or modification of an existing guideline), there are three sequential steps: • submission of a concept paper to the ich steering committee by an ich party or an observer • endorsement by the steering committee • establishment of a working group the concept paper is the start of all ich harmonization activities. this document provides a short summary of the proposal (maximum two pages) and provides the information indicated below: • type of harmonization action proposed: for example, a new harmonized tripartite guideline and recommendation, or a revision of an existing guideline (indicating the category of procedure). • statement of the perceived problem: brief description with an indication of the magnitude of the problem currently caused by a lack of harmonization, or anticipated if harmonization action is not taken. • issues to be resolved: a summary of the main technical and scientific issues that require harmonization. • background to the proposal: further relevant information (e.g., the origin of the proposal, references to publications, and discussions in other forums). • type of expert working group: recommendation on whether the ewg should be a six-party group (for topics related to the r&d of a new drug substance and product) or an extended ewg (e.g., gmp). if necessary, further documentation and reports may be added to the concept paper. depending on the category of harmonization activity, a business plan may also be required. the business plan outlines the costs and benefits of harmonizing the topic proposed by the concept paper. only when the ich steering committee endorses a concept paper, and where appropriate a business plan, can the harmonization activity be initiated. a preliminary determination will be made on whether the topic is of sufficient interest to all parties and can be accommodated within the ich work schedule. the steering committee takes the following points into account when discussing a concept paper: • objectives and expected outcome of the harmonization action • categories of the ich process • composition of the ewg or iwg appointed to discuss the technical issues • setting a timetable and action plan for the ewg/iwg the concept paper may need to be revised and updated to reflect the steering committee discussions and conclusions. if the steering committee agrees that a topic may warrant further consideration and a business plan needs to be developed, an informal ewg/iwg will be formed and the group will work through e-mail, teleconference, and rarely, face-to-face meetings. the first tasks of the informal ewg/iwg will be to finalize a concept paper and develop a business plan. the revised concept paper and business plan will be sent prior to, and presented at, the next steering committee meeting. at its meeting in yokohama, japan (in june 2006), the ich steering committee agreed to have the final versions of the concept papers and business plans available on the ich website, for public information. depending on the type of harmonization activity proposed, the ich steering committee will endorse the establishment of either an ewg or an iwg. ich harmonization activities fall into four categories. as presented in table 2 , these four categories cover the creation and development (stepwise progression), implementation, revision, and maintenance of guidelines. no procedure is in place for the withdrawal of existing ich guidelines because it happens very rarely. when guideline q1f (stability data package for registration applications in climatic zones iii and iv) was withdrawn, an explanatory note was released following the endorsement of the withdrawal by the ich steering committee at its meeting in yokohama, japan in june 2006. withdrawal notifications were also released by the ema, mhlw, and us fda. ▸ the formal ich procedure: the formal ich procedure follows a stepwise approach consisting of five steps with "decision points" at step 2 and step 4 that enable the steering committee to monitor the progress of the harmonization topics. this procedure is followed for the harmonization of all new ich topics. a streamlined procedure is also available when necessary. the procedure is initiated with the endorsement, by the steering committee, of a concept paper and business plan. an ewg with membership as specified by the concept paper is subsequently established. the ewg works to develop a draft guideline and bring it through the various steps of the procedure that culminate in step 5 and the implementation in the ich regions of a harmonized tripartite guideline. • step 1: consensus building when the steering committee adopts a concept paper as a new topic, then the process of consensus building begins. the ewg prepares an initial consensus technical document, based on the objectives set out in the concept paper and in consultation with experts designated to the ewg. the initial draft and successive revisions are circulated for comments within the ewg, providing fixed deadlines for receipt of those comments. work is conducted via e-mail, teleconferences, and web conferences. if endorsed by the steering committee, the ewg will also meet face-to-face at the biannual steering committee meetings. interim reports on the progress of the draft are made to the committee on a regular basis. when consensus is reached among all ewg members, the ewg signs the step 1 experts signoff sheet. the experts document with ewg signatures is submitted to the steering committee to request adoption under step 2a of the ich process. step 2a is reached when the steering committee agrees, based on the report of the ewg, that there is sufficient scientific consensus on the technical issues for the technical document or recommendation to proceed to the next stage of regulatory consultation.this technical document is made public on the ich website. on the basis of the technical document, the three ich regulatory parties take the actions they deem necessary to develop the "draft guideline." the consensus text approved by the three regulatory ich parties is signed off by the three regulatory ich parties as the step 2b draft guideline. • step 3: regulatory consultation and discussion regional regulatory consultation: at this stage, the guideline embodying the scientific consensus leaves the ich process and becomes the subject of normal wide-ranging regulatory consultation in the three regions. in the eu it is published as a draft chmp guideline, in japan it is translated and issued by the mhlw for internal and external consultation, and in the us it is published as draft guidance in the federal register. step 2 guidelines released for consultation are also available on the ich website. dras and industry associations in non-ich regions may also comment on the draft consultation documents by providing their comments to the ich secretariat. after obtaining all regulatory consultation results, the ewg that organized the discussion for consensus building will be resumed. the same procedure described in step 1 is used to address the consultation results into the step 2 final document. the draft document to be generated as a result of step 3 is called the step 4 draft guideline. the step 4 document with regulatory ewg signatures is submitted to the steering committee to request adoption as step 4 of the ich process. step 4 is reached when the steering committee agrees, on the basis of the report from the regulatory chair and the regulatory rapporteur of the ewg, that there is sufficient scientific consensus on the draft guideline. this endorsement is based on the signatures from the three regulatory parties to ich affirming that the guideline is recommended for adoption by the regulatory bodies of the three regions. in the event that one or more parties representing industry have strong objections to the adoption of the guideline on the grounds that the revised draft departs substantially from the original consensus, or introduces new issues, the regulatory parties may agree that a revised document should be submitted for further consultation. in this case, the ewg discussion may be resumed. the step 4 final document is signed off on by the steering committee signatories for the regulatory parties of ich as an ich harmonized tripartite guideline at step 4 of the ich process. • step 5: implementation having reached step 4, the harmonized tripartite guideline moves immediately to regulatory implementation, the final step of the process. this step is carried out according to the same national or regional procedures that apply to other regional regulatory guidelines and requirements in the eu, japan, and the us. information on the regulatory action taken and implementation dates are reported back to the steering committee and published by the ich secretariat on the ich website. in the eu, ich guidelines are submitted to the chmp for endorsement and the timeframe for implementation is established (usually six months). ich guidelines are available on the ema website. in japan, ich texts are translated into japanese and subsequent pharmaceutical and medical safety bureau notification for the promulgation of guidelines written in japanese is issued with an implementation date. the notifications on guidelines in japanese and also english attachments (ich texts) are available on the pmda website. in the us, the us fda publishes a notice with the full text of the guidance in the federal register. step 4 guidance is available for use on the date it is published in the federal register. they are available on the us fda website. ▸ the q&a procedure: the q&a procedure is followed when additional guidance is considered necessary to aid in the interpretation of certain ich harmonized tripartite guidelines and ensure a smooth and consistent implementation in the ich regions and beyond. the q&a procedure is initiated with the endorsement of the steering committee of a concept paper. in the case of major implementation activities, the steering committee may also consider the need for a business plan. an iwg with membership as specified by the concept paper is subsequently established. the development and adoption of the q&a follow an established process. questions received from stakeholders are collected, analyzed, reformulated, and ultimately used as model questions for which standard answers are developed and posted on the ich website. the incoming questions are not answered individually, rather they serve to highlight areas that need additional clarification and are then used to develop a model question that will be answered in the q&a document. based on the level of guidance given by the answers, the iwg will assess whether the q&a document should be a step 2b document and published for comments or a step 4 document and published as final. the document should be step 2b if, based on the answers provided, it sets forth substantial new interpretations of the guideline(s). the document should be a step 4 if, based on the answers provided, it sets forth existing practices or minor changes in the interpretation or policy of the guideline(s). the document then follows the normal path of a step 2b/step 4 document as per the formal ich procedure. the revision procedure applies when an existing adopted guideline needs to be revised or modified. it is almost identical to the formal ich procedure (i.e., five ich steps). the only difference is that the final outcome is a revised version of an existing guideline rather than a new guideline. the revision of a guideline is designated by the letter r1 after the usual denomination of the guideline. when a guideline is revised more than once, the document will be named r2, r3, r4, and so on with each new revision. the maintenance procedure is used to add standards to exist ing guidelines and/or recommendations or to provide an update based on new information. this procedure has been used to amend the addendum of guideline s5(r2), "detection of toxicity to reproduction for medicinal products & toxicity to male fertility," and guideline m3(r1), "maintenance of the ich guideline on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals," on november 9, 2000. it is currently applicable for changes to the q3c guideline on residual solvents, the q4b annexes, and m2 recommendations. in each case, the procedure is used when there is new information to be added or when the scientific/technical content is out-of-date or no longer valid. for the q3c guideline, this maintenance procedure is used to revise the permitted daily exposure (pde) as new toxicological data for solvents become available. since its creation, and pursuant to its main goal, ich has released a number of guidances, each harmonizing technical requirements for registration of medicinal products. for each technical topic, the relevant ewg discussed the important question of whether there is scientific justification for the different regional requirements, and whether it would be possible to develop a mutually acceptable guidance. the objective of this scientific discussion is to reach a scientific consensus whatever the time and effort it requires [93] (and not a "compromise" that would be an unacceptable decrease of certain regional requirements without scientific justification/ basis). ich has also worked on broader projects (e.g., meddra and ctd), which have been critical for the international exchange of information. the ultimate goal of ich activities is to remove redundancy and duplication in the development and review process such that a single set of data could be generated to demonstrate the quality, safety, and efficacy of a new medicinal product. the steering committee has given priority to harmonizing the technical content of the sections of the reporting data. the first ich guideline to deal with harmonizing the format of reporting data was e3, "content and format of clinical study reports." this guideline describes a single format for reporting the core clinical studies that make up the clinical section of a registration dossier. the goal of developing a harmonized format has led to the creation of the ich guideline m4, "the common technical document" (ctd), further described below. at the first ich steering committee meeting it was decided that the topics selected for harmonization would be divided into safety, quality, and efficacy in order to reflect the three criteria that are the basis for approving and authorizing new medicinal products. since then, ich has created a fourth category called multidisciplinary, which covers crosscutting topics that do not fit uniquely into one category or another. therefore, today ich topics are divided into four categories (quality, safety, efficacy, and multidisciplinary) and ich topic codes are assigned according to these categories. a summary of harmonized topics is provided below. an updated list of these guidances (including their status) can also be downloaded from the ich website (and also from the us fda, pmda, and ema websites). the guidelines under this category provide harmonization of information related to the development, manufacturing, and testing of medicines. they specifically cover stability testing (q1), validation of analytical procedures (q2), impurities testing (q3), pharmacopoeial text harmonization and interchangeability (q4), quality information on biotechnological products (q5), specifications (test procedures and acceptance criteria) (q6), gmp (q7), pharmaceutical development (q8), quality risk management (q9), and pharmaceutical quality systems (q10). in addition, the ich steering committee endorsed on april 11, 2008 the development of a new q11 guidance related to the development and manufacture of drug substances (chemical entities and biotechnological/biological entities). the guidelines under this category provide harmonization of information related to in vitro and in vivo preclinical studies. they cover all preclinical studies performed during the development of new pharmaceutical products, such as carcinogenicity studies (s1), genotoxicity studies (s2), toxicokinetics and pharmacokinetics studies (s3), toxicity studies (s4), reproductive toxicology studies (s5), pharmacology studies (s7), and immunotoxicology studies (s8). guideline s6 specifically addresses preclinical safety evaluation for the biotechnological products. the ich steering committee also endorsed on may 10, 2007 the development of a new s9 guideline that provides preclinical guidelines on oncology therapeutic development. finally, the photosafety evaluation of pharmaceuticals was endorsed as a new topic (s10) by the ich steering committee in june 2010. the guidelines under this category provide harmonization of information pertaining to the clinical evaluation of pharmaceutical products. most of these guidelines relate to the assessment and management of safety data (e1 and e2 guidelines). these guidelines cover: • all the above efficacy guidelines can be applied to all therapeutic classes of drugs. until now, ich has focused the discussion on general (i.e., nontherapeutic class-specific) guidances. however, there are, in some therapeutic classes, individual drug evaluation guidelines among the three regions. differences between guidelines can result in obstacles to the mutual use and acceptance of clinical data. at the steering committee meeting in september 1998, it was agreed that this should be adopted as a new area of work for ich, with the first such guideline being undertaken as a "pilot study" to assess the feasibility of extending work in this area. it was agreed to develop the first therapeutic class-specific guideline for antihypertensive drugs. no other guideline for clinical evaluation of a specific therapeutic category has been developed since this guideline (e12). this category was created to include guidelines covering topics that do not fit uniquely into one of the above three categories. in addition to the technical guidelines described in previous sections, ich set up ewgs to harmonize medical terminology (m1: meddra), drug dictionaries (m5), and the format and organization of data in regulatory applications (m4: ctd) in order to ease the exchange of information. the creation of electronic standards (m2: estri) was also critical for the quick exchange of common, agreed-upon data. in november 2010, the ich steering committee endorsed the establishment of an ewg for the electronic common technical document (ectd) and assigned the topic code "m8" (even though work in relation to the ectd had previously been undertaken by the m2 ewg). all these harmonization initiatives are critical achievements that required a lot of effort from their respective working groups. they are important activities that greatly contributed to the international harmonization of pharmaceutical regulations because they harmonized and facilitated the exchange of information between regulators and pharmaceutical companies. due to the importance of these initiatives, each of them is detailed in the specific subsections below. guideline m3 covers a specific topic relating to both safety and efficacy issues. for this reason, it has been classified as a "multidisciplinary topic." this joint safety and efficacy guideline provides principles for nonclinical strategies (i.e., scope, timing, and duration of nonclinical safety studies) in relation to the conduct of clinical trials. it helps to reduce the differences between the ich regions and it also provides recommendations to reduce animal use during research and development (e.g., inclusion of any in vivo evaluations as additions to general toxicity studies instead of performing separate studies). this guideline is definitively aligned with the overall ich objectives, as its purpose is to facilitate the timely conduct of clinical trials, reduce the use of animals in accordance with the 3rs (reduce/refine/replace) principles, and reduce the use of other drug development resources. it clearly promotes the safe and ethical development and availability of a new pharmaceutical as quickly as possible. finally, the ich steering committee endorsed (in june 2010) the "assessment and control of dna reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk" as a new topic (m7). meddra was developed by an ich ewg in the early 1990s. it was designed to support the classification, retrieval, presentation, and communication of medical information internationally and throughout the product regulatory cycle. prior to meddra, different medical dictionaries (and also different versions of these dictionaries) were used, such as the world health organization adverse reaction terminology (who-art), the coding symbols for a thesaurus of adverse reaction terms (costart) from the us fda, and the japanese adverse reaction terminology (j-art) from the mhlw. at that time, several worldwide authorities were looking for a more cost-and time-efficient way of processing suspected adverse reaction reports (e.g., the united kingdom medicines control agency [uk mca] were developing a new system of coding called adroit). it became obvious that this activity should fall under the auspices of ich. the goal of ich in developing meddra was to have an internationally recognized standard, and medically rigorous and well-maintained terminology to facilitate communication. it is indeed one of the most important ich projects for ensuring the global exchange of clinical information. this international medical terminology is particularly important in the electronic transmission of adverse event reporting (both in the pre-and post-marketing areas), as well as in the coding of clinical trials data. the meddra dictionary is a multi-axial terminology that provides a set of terms that consistently categorizes medical information. it includes terminology for symptoms, signs, diseases and diagnoses, and therapeutic indications. it is organized by system organ class (soc), divided into high-level group terms (hlgt), high-level terms (hlt), preferred terms (pt), and finally into lower-level terms (llt). the meddra dictionary has been translated into many languages. as the terminology itself does not contain specific guidelines for its use, an ich working group has been charged to develop two guides: ▸ "meddra term selection: points to consider": this document was created to achieve consistency in the way users assign particular terms to particular symptoms, signs, diseases, etc. ▸ "meddra data retrieval and presentation: points to consider": this document provides guidance on retrieval and on sorting and presenting data in the most understandable and reproducible way for the benefit of drug development, pharmacovigilance, and risk management. these two documents provide a best practice approach for the use of meddra. they are revised for each new meddra version release. in addition, the meddra dictionary includes standardized meddra queries (smqs) that were developed (in collaboration with cioms) to facilitate the retrieval of meddra-coded data as a first step in investigating drug safety issues in pharmacovigilance and clinical development. smqs are groupings of terms from one or more meddra system organ classes (socs) that relate to a defined medical condition or area of interest. they are intended to aid in case identification. because the terminology requires constant updating and maintenance, it was agreed that a maintenance and support services organization (msso) would be needed to carry out this task and to distribute the terminology, on license, to users in industry and regulatory agencies. the msso, contracted by ich with technical and financial oversight by the meddra management board, is tasked to maintain, develop, and distribute med-dra. since the release of version 1.0 in 1994, meddra has become the accepted international standard for all worldwide regulatory activities (meddra is not yet mandatory in the us). as a single global, standardized medical terminology, meddra speeds the exchange of clinical information, facilitating research and safety monitoring, and making the regulatory approval process more efficient and responsive. different translations of meddra have been released. in march/april 2008, meddra was also implemented in the who vigibase, providing a global repository of meddra-coded safety data that can be used as a substantial tool for pharmacovigilance. during a meeting on october 27-28, 2007 in yokohama, japan, the meddra management board announced fee reductions for lower revenue subscribers. these reductions are in keeping with the meddra management board's goal of facilitating the use of med-dra for all users. since january 2007, access to meddra has been free for academic organizations, hospitals, healthcare providers, and other users involved in noncommercial activities. the objective of the electronic standards for transmission of regulatory information (estri) project was to facilitate international electronic communication. to this end, an ich multidisciplinary expert working group (called m2 ewg) was established during the ich meeting of 1994 in brussels, belgium. the m2 ewg was to evaluate and recommend estri that meet the requirements of the pharmaceutical companies and dras from the three ich regions. since 1994, the m2 ewg has developed the technological framework and recommended solutions for international information exchange. this was obtained by gathering requirements, assigning specific tasks, evaluating international standards and products, and recommending a functional architecture. this project included the verification of procedures for consistent, accurate information transfer, and the evaluation of encryption technologies and key certification procedures for the transfer of regulatory information. the working group has undertaken test projects to define logical electronic communication standards in order to ensure the integrity of information and data exchange between pharmaceutical companies and authorities. to allow flexible change, some of the activities of the ewg result in recommendations that do not follow the formal ich step process. they are agreed upon in the ewg, signed by all parties of the ewg, and are endorsed by the ich steering committee at its different meetings. these recommendations, which have been modified and improved over time, provide various open international standards that allow for the international transmission of information regardless of the technical infrastructure. to facilitate the use of these recommendations, the m2 ewg has also developed a glossary for the technical terms. today, six m2 recommendations are available. they cover and standardize general aspects, but also the choice of file format and information transfer as described in table 3 . recommendations were also prepared for the choice of physical media (i.e., floppy disks, cd-r, and dvd-ram). because these physical media are not relevant anymore, these recommendations were retired in june 2008. in addition to the recommendations, the m2 ewg also developed several specifications with regard to the electronic exchange of information: ▸ the first specification developed by the m2 ewg was related to the electronic transfer of the individual case safety report (icsr) presented in ich guideline e2b (data elements for transmission of individual case safety reports). following the development of the e2b guideline, it became necessary to work on an electronic specification to guide the pharmaceutical companies on how to provide the information required by the e2b guideline. indeed, successful electronic transmission of icsr relies on the definition of common data elements (provided in the e2b guideline), but also a standard electronic transmission procedure. the first version of this specification was approved by the steering committee under step 2 in 1997. since then this specification has been modified because its implementation and use had to be aligned with the evolution of the ich e2b and m1 (meddra) guidelines. as a result of this activity, adverse event (ae) data can be extracted, populated, and electronically transmitted in the manner specified by the ich icsr message from safety and surveillance databases. even if it has required a lot of work, the implementation of electronic reporting of icsrs based on the ich e2b, m1, and m2 standards progressed very rapidly across the ich regions. thanks to these standards, pharmaceutical companies can now exchange case reports electronically via gateway with some dras (such as the us fda or ema). ▸ the second specification developed by the m2 ewg was the electronic common technical document (ectd) created as the electronic message for the common technical document (ctd) detailed in ich guideline m4. this specification has since been maintained by the ectd iwg. the ectd specification, based on xml (extensible markup language) technology, allows for the electronic submission of the ctd from applicant to regulator, taking into consideration the facilitation of the creation, review, lifecycle management, and archiving of electronic submissions. while the table of contents is consistent with the harmonized ctd, the ectd also provides a harmonized technical solution to implementing the ctd electronically. this ectd specification is applicable to all modules of initial registration applications and for other submissions of information throughout the lifecycle of the product, such as variations and amendments. the backbone has been developed to handle both the regional and common parts of submissions. implementation of ectd has begun across the ich partner and observer regions. for example, since january 1, 2008, all electronic submissions to the us fda are required to be in ectd format. ▸ in 2003, the m2 ewg published the first version of the study tagging file (stf) specification, which is supplemental to the ectd. this specification has since been modified several times. for each study included in modules 4 and 5 of an ectd submission, the stf includes information allowing for the identification of all the files associated with this specific study. this is additional information to the ectd backbone files that already include many items, but do not contain enough information on the subject matter of several documents (e.g., study report documents) to support efficient processing and review of applications. the common technical document (ctd) is one of the major and most well-known achievements of ich, and like all other big harmonization projects of ich, required much effort. it provides a harmonized structure and format for regulatory applications. the objective is to reduce the time and resources needed to compile applications for registration of medicines in the different ich regions. additionally, this new common format allows dras to have more consistent reviews, helping them to perform analysis across applications and to exchange information among them. before the development of the ctd, each region had its own requirements for the organization of technical reports in the submission and for the preparation of the summaries and tables. in japan, applicants had to prepare the gaiyo, which organized and presented a summary of the technical information. in europe, expert reports and tabulated summaries were required, and written summaries were recommended. the us fda had specific guidelines regarding the format and content of the new drug application (nda). in 1996, the ich industry representatives proposed assembling the information generated during the development of a product in the same order. this proposal followed an industry survey in may 1996 that assessed the time and resources needed to convert an eu marketing authorization application (maa) into a us nda (and the reverse). this survey showed that an average of three to four months and 20 to 30 people were required for the conversion from one format to the other. with the acceptance in all three regions, the ctd now avoids the need to generate and compile different regional versions of most of the registration dossier sections. the ctd was adopted as an ich topic at the steering committee meeting that took place just before the ich4 meeting (july 1997). the ctd specifications reached step 2 of the ich process at the steering committee meeting in july 2000. after public consultation, step 4 was achieved at the ich5 conference in san diego, california in november 2000. on september 12, 2002 (at the washington, dc meeting), numbering and section headers were then edited for consistency and use in the ectd. the ctd consists of five modules (module 1 is region specific, and modules 2, 3, 4, and 5 are intended to be common for all regions): ▸ module 1 includes administrative information (i.e., application form) and proposed prescribing information. ▸ module 2 summarizes data included in modules 3, 4, and 5 and is organized in seven subsections: • ctd the ctd is defined by a general ich guideline (m4) and three specific technical guidelines (m4q, m4s, and m4e, which cover the quality, safety, and efficacy parts of the ctd, respectively). a q&a document is associated with each of these four guidelines to facilitate implementation of the ctd. the ich parties agreed to implement this harmonized format in the three regions by july 2003. it is indeed used today in the three ich regions: it is mandatory in the eu and japan, and "highly recommended" in the us (the current legislation does not allow the us fda to make it mandatory). moreover, this format is also used in other countries (e.g., australia, canada, turkey, etc.), and derivatives of the ctd have been developed in other regions (e.g., the actd developed by the asean countries). this harmonized format is indeed one of the great successes of the ich process. while the realization of the ctd took many years, there is now a common format for the regulatory submissions across the three ich regions (europe, japan, and the us) and beyond. this facilitates pharmaceutical companies in making simultaneous filings in the ich regions as it eliminates the extensive work previously required to convert from one format to another. however, the ctd is not a "global dossier." it remains only a harmonization of format instead of a harmonization of content. this initial misunderstanding, certainly created by the desire of many people to accelerate the harmonization of technical requirements, led to a lot of criticism against this new format. however, the ctd cannot be a truly global identical dossier (including the same information/data/level of detail) if all technical requirements are not fully harmonized. moreover, the submission's content may also be different for several reasons, such as different individual regulations, legal status, or requirements, and different manufacturing situations for the three regions. indeed, although the ctd provides a common format for regulatory applications, the actual content must still meet local regulations, laws, and statutes. as a result, despite being presented in the same order, the required content of modules 2 to 5 may vary by region. for example, the integrated summary of efficacy/integrated summary of safety (ise/ iss) that were requested by the us fda before the implementation of the ctd are still needed. because these integrated summaries are unique to the us, the table of contents of the ctd does not specifically include them. a specific us fda guidance was released in june 2007 to help pharmaceutical companies decide where to place these us-specific ise/iss documents within the structure of the ctd. to conclude, even if the ctd is "only" an agreed-upon common format for the modular presentation of summaries, reports, and data, it provides obvious advantages. the ctd allows companies and dras to harmonize the terms and way of communication [94] . having the same "language" will certainly help the harmonization of content, and ultimately the harmonization of technical requirements. indeed, regulatory reviews and communication with the applicant will be facilitated by a standard document of common elements. in addition, exchange of regulatory information between dras will be simplified. this increase of communication between authorities and between authorities and pharmaceutical companies will obviously facilitate expertise and opinion sharing (related to the safety, efficacy, and quality of the development product) in a timely manner that will ultimately provide benefits to patients by providing quality medicines more quickly on the market. like meddra, the objective of this project was indeed to support all aspects of pre-and post-approval pharmacovigilance activities as well as communication of regulatory information. for example, meddra and the harmonization of drug dictionaries are critical in the transmission of the icsr presented in ich guideline e2b (data elements for transmission of individual case safety reports). the transmission of structured data (especially electronically) does imply the use of controlled vocabularies. before the ich initiative, there was no harmonized standard to document information and data on medicinal products. regulators in the different regions had established their own standards, which differed in data format, content, language, and applied standard terminology (e.g., terminology used for substances, routes of administration, pharmaceutical forms, etc.). the who drug dictionary, or a modified version of this product, was sometimes used. this lack of internationally harmonized standards related to core sets of medicinal product information and medicinal product terminology made the scientific evaluation, comparison, and exchange of drug data (especially in the area of pharmacovigilance) very difficult. the activity on the m5 guideline only began in 2003. following the example and success of meddra, the ich steering committee at its meeting in november 2003 agreed to launch this new harmonization initiative and to develop a new tripartite guideline that defines the data elements and standards for drug dictionaries. during the ich meeting in tokyo, japan in february 2003, who presented a white paper regarding the concepts of a global drug-coding dictionary. during this meeting, the steering committee agreed to convene an informal discussion group in brussels, belgium during the ich meeting in july 2003 to allow for a discussion of this proposal. an informal working group was then established to develop a concept paper and prepare a business plan. the m5 guideline was released for consultation at step 2 of the ich process on may 10, 2005, along with controlled vocabulary lists for routes of administration and units of measurement. this guideline was subsequently submitted to the iso for development under this process. step 2 guideline was updated based upon feedback received during consultation in 2005, as well as additional considerations following its submission to iso for development as an international standard. key parts of this updated guideline will be incorporated into the ich "implementation guide for identification of medicinal products message specification," which is currently undergoing development as an iso standard. ▸ achievements so far: for two decades, the ich process has achieved much success and benefited both dras [95-1] and pharmaceutical industries . more importantly, this harmonization has been pursued in the interest of patients and public health to prevent unnecessary duplication of clinical trials in humans and to minimize the use of animal testing without compromising the regulatory obligations of safety and effectiveness. to achieve this objective, the goal of ich has been to promote international harmonization by bringing together representatives from the eu, japan, and us to discuss and establish common guidelines and standards. through the ich process, considerable harmonization has been achieved in the technical requirements for the registration of pharmaceuticals for human use. this is now a mature harmonization initiative. since its creation, over 50 harmonized guidelines have been developed in the areas of quality, safety, and efficacy in order to eliminate duplication in the development and registration process. moreover, common harmonized tools for regulatory communication (meddra, ctd, estri) have also been made available. this represents an extraordinary contribution to the global harmonization of pharmaceutical regulations. these guidelines already form a solid basis for harmonized application of technical requirements during the registration process. while the technical output of the ich process has been very positive, the importance of the unique way in which ich operates should also be noted. indeed, in addition to the practical harmonization of specific technical items, one of the major outcomes of ich has been to create a forum that allows experts from different countries and with different backgrounds to communicate, exchange, discuss, and share their experience and information in a structured manner. this is of course an essential first step to any harmonization. finally, another important achievement of ich is to be well recognized on a worldwide basis. ich guidelines have been adopted and are now followed outside the ich regions (e.g., switzerland, canada, and australia, and also many rhis). although ich's initial focus was the development of guidelines for use in the ich regions, increased globalization drastically modified the international cooperation environment. in response to a growing interest from beyond the ich regions in the use of ich guidelines, the ich steering committee took the first step in march 1999 of establishing the ich gcg. in november 2003, new terms of reference and rules were endorsed for the gcg with the aim of establishing partnerships beyond the ich regions to promote a better understanding of ich guidelines globally. since then, rhis from across the globe, but also representatives from dras and departments of health (doh) that are either a major source of api or clinical trials data have been invited to participate in the gcg meetings and listen to technical topics at the level of the steering committee (at the biannual ich meetings). in addition, as per a decision of the ich steering committee in november 2010, invited rhis and dras/doh may now also nominate technical experts as active members of ich ewgs. the implementation of ich recommendations and standards outside the three ich regions is indeed very important as it allows industry to better develop medicinal products for the global market. as a consequence of this expansion to non-ich regions, training and capacity building have become a key focus of the ich gcg. in 2006, the gcg implemented a strategy for addressing training and capacity needs to help ensure the most effective use of resources, opportunities, and the realization of desired outcomes. over the past few years, the gcg has responded to numerous requests for training, providing ich expertise both for the development of training programs and for the delivery of the training itself. today, the gcg and the ich steering committee continue to implement new tools to promote a better understanding and use of ich guidelines and recommendations 96] . one of the drivers of this success is in the fact that this harmonization process is based on scientific consensus developed between industry and dra experts. before ich, the industry and regulators never sat at the same table in an international forum to discuss the science of drug development in order to develop best practices across different regions. this joint effort allows not only for the involvement of the best experts (from both the authorities and pharmaceutical industries) in specific technical discussions, but also for ensuring that discussions take into account both the regional legislations and the practical impact on the development of pharmaceutical products. this inclusion of both industry and regulators increases commitments to the common goal (i.e., implementation of the ich tripartite, harmonized guidelines, and recommendations) that has obviously been a key factor in the success of ich. the results of a survey on the impact of ich, presented during the ich6 conference in osaka, japan, showed a high degree of satisfaction by both dras and industry with the completed ich guidelines, and continuous support from both sides for ich activities. the second driver of ich's success is linked to its well-defined structure and process. in the beginning years of ich, the steering committee organized its structure around the working groups, which included world-recognized experts. this decision was critical because it allowed ich to have very robust scientific and technical recommendations, most of the time accepted and implemented without fundamental criticism. the steering committee has of course also been key as the governing body that gives direction, selects the topics for harmonization, and ensures completion of projects in a timely manner (not always easy when one's goal is consensus). in addition to the structure, the steering committee has also been able to define a process that supported this incredible harmonization task in a structured and organized way, supported by different players such as the ich secretariat and coordinators. indeed, the stepwise approach that has been put in place for the development of guidelines (the defined five-step process with decision points at step 2 and step 4) has been very important. this approach allowed for the creation of comprehensive drafts by a small number of experts (the best environment for facilitating focused discussion and development of consensus) and public review before implementation (which promotes transparency, and avoids surprises and post-approval issues). the creation of concept papers and business plans that the steering committee put in place at a later stage are also fundamental to (1) define clear goals, and (2) help to monitor progress towards the predefined goals. finally, the review of progress during regular meetings also ensures commitment, follow-up, and therefore the seriousness of this initiative. finally, the extension of ich beyond the ich regions was possible because the steering committee understood early on that its activity could not be restricted to the ich regions with the increasing globalization of drug development and manufacture. indeed, research and manufacture of new products is not confined to the three ich regions any longer. clinical trials are carried out throughout the world and many non-ich countries are involved in the development and manufacture of pharmaceutical products. to increase transparency and promote collaboration outside ich regions, the steering committee accepted observers (e.g., canada), worked with other international organizations (efta and who), and involved other regions/countries in this process via the ich gcg, which evolved over time. all these actions allowed the ich work to be expanded to most of the regions/countries in the world, and its harmonization benefits to be available worldwide. the collaboration with non-ich regions is today one of the priorities of ich in order to increase commitment of these regions and facilitate worldwide implementation of ich recommendations. ▸ limitations and challenges for the future: as mentioned above, ich has been an incredible contributor to the international harmonization of pharmaceutical regulations. ich has been successful in achieving harmonization (initially of technical guidelines and then on the format and content of registration applications), and has positively impacted the global development of new drugs. all parties agree that there is a need to maintain this harmonization in the interest of the patient and public health. now that the process and networks are in place, it seems indeed obvious that ich needs to continue its activities as one of the major players in the international harmonization of pharmaceutical regulations. further harmonization activities should be continued in a focused manner. however, in an evolving international environment, some aspects of this initiative need to be reviewed as new approaches may be needed. indeed, some aspects of this initiative may be optimized in order to better handle new and future challenges. the first challenge of ich, which the steering committee has already acknowledged, is the implementation and maintenance of already developed guidelines. the current magnitude of successful harmonization actions and the need for these to remain current in a rapidly changing environment calls for focusing more effort on the implementation and monitoring of ich commitments. development of iwgs or task forces to manage this challenge will be key to its success. this focus on implementation and maintenance should not, however, impact the work on new harmonization topics that still need to be discussed. these new topics for harmonization need to be rigorously assessed for need (i.e., scientific merit/emerging science) and feasibility (i.e., expected outcome, timeline, and resource requirements). another major challenge for ich is to confirm its worldwide expansion and to continue to develop and strengthen its collaboration and partnership outside the ich regions in order to better integrate these regions into the ich process. at the time of ich establishment, it was agreed that its scope would be confined to registration of new drugs and medicines in western europe, japan, and the us because the vast majority of the new drugs were developed and manufactured in these three regions. however, since then, there has been strong involvement of other parts of the world. canada and australia are key markets for pharmaceuticals, and are often involved in global clinical studies. more recently, the emergence of other countries has been recognized in all areas, including the pharmaceutical industry. as already recognized by the ich steering committee, the success of ich in the ich regions only will not be relevant any longer. the modification of the landscape obliges ich to review and broaden its objectives. the current organization (with the gcg) that initially responded to this increased globalization may not be the most appropriate solution for future stages of development. the ich organization and systems need to be reviewed and revised to better serve these broader objectives. in 2000 (during ich5), the ich steering committee reviewed its structure and concluded that this structure continues to be appropriate. however, in order to increase transparency, they welcomed appropriate participation of other interested parties in a flexible and ad hoc manner on topics that also affected them. a decade later, the new evolving environment requires a bigger revision of its structure and process. the ich steering committee understands this urgent need and has declared that a new ich organizational structure will be adopted. the steering committee will set the framework for new rules on governance, decision making, and membership [92-1]. finally, ich has to become more proactive in new emerging topics to prevent future disharmony. the gene therapy topic is an interesting example that demonstrates the previous lack of commitment of ich to "proactive harmonization." in september 2002, the ich steering committee established a gene therapy discussion group (gtdg) in recognition of the rapidly evolving area of gene therapy medicines. the gtdg developed several ich consideration documents in this area. despite this first positive step/outcome, the development of these consideration papers and the activities towards the development of a new multidisciplinary guideline (guideline m6) was discontinued in september 2011 because "currently the ich regions do not have the resources to support the development of further ich consideration documents" in this domain . recently, the ich steering committee started to define a new proactive approach to identify and creatively pursue advancements in science . if ich succeeds in these challenges, it will certainly become a real international organization/forum (vs. a multiregional initiative) where proactive discussion on all past and new technical requirements for registration of pharmaceuticals for human use will be discussed. however, some of these challenges are not new. ich acknowledged these challenges years ago and has already tried to resolve them without succeeding (e.g., proactivity), confirming the difficulties of this task. to face these challenges, ich needs to revise its structure and engage a new phase in order to address the evolution of regulations and the globalization of drug development and manufacturing, and to promote better proactivity in harmonization. the ongoing ich reform is obviously an important milestone toward resolution of current limitations. europe was the first major regional bloc established after world war ii. following this, there have been many regional harmonization activities throughout the world, especially over the past 30 years. countries in different regions of the globe have organized themselves into closer economic and political entities. these movements have transformed the world, both economically and politically, as they create new opportunities and also new challenges (e.g., the management of regulations and standards disharmony). these regional harmonization initiatives include members with closer interests and needs, compared to global initiatives, allowing further harmonization and cooperation. this level of harmonization is also essential for developing countries that may not have access to all global harmonization discussions due to sparse resources or lack of expertise. regional cooperation can represent their interests and challenges and allow them to be heard at the global level. ii this level of cooperation is also essential for establishing region-wide pooled procurement systems. very diverse initiatives (each with a different scope, objective, structure, and working model) were established due to different cultural, historical, and political contexts. they range from a simple technical and scientific intergovernmental cooperation model to an advanced integration model. ii although all countries are part of who, many countries are not represented at ich where global standards are developed. however, most of the major regional harmonization initiatives are today represented via the ich gcg group. the political and economic development of each region, and sometimes subregions, has indeed shaped the level of harmonization in the pharmaceutical area: ▸ scenario 1 -pharmaceutical harmonization in the context of an economical and political integration: in certain regions, economic integration among countries implies integration of pharmaceutical regulations and the harmonization of technical standards. this degree of integration varies from one region to another (and sometimes from one subregion/country to another), but the harmonization of regulations and policies and standards are very important to create a consistent regional legislative framework and a common certification system for products across regions. europe is the best example in terms of advanced harmonization and integration with the development of a centralized system, institutions, and procedures for the registration of medicines to be marketed in the single market. jj ▸ scenario 2 -pharmaceutical harmonization in the context of a general political agreement: other initiatives follow a general political agreement, mostly signed to avoid conflicts or wars in certain areas in the world or to facilitate economic growth and trade within a region (e.g., asia-pacific economic cooperation [apec]), without an integration goal. the output of this harmonization initiative is variable, but most of the time does not produce a deep harmonization of pharmaceutical regulations because it is not the primary objective of the agreement and therefore the resources and efforts from the countries for this pharmaceutical regulation harmonization are variable. ▸ scenario 3 -pharmaceutical harmonization based on a specific intergovernmental agreement: in other regions, a simple technical and scientific intergovernmental cooperation has been established, focusing solely on the harmonization of pharmaceutical regulations. this is the case of the pandhr initiative in the americas where regional integration has not been the objective because countries continue to present very different systems and degrees of development, and there are no political commitments to create a single market. countries only cooperate to promote harmonization without creating common legislation and procedure. this is a scenario that produces good harmonization of pharmaceutical regulations because this is the focus of the initiative, compared to scenario 2 above, which is a derivative of a broader political agreement. however, the risk and difficulty of this scenario is its implementation. because there is not an ultimate economic and political goal (e.g., developing a single market as in scenario 1), implementation of the agreed-upon recommendations in the national law is somewhat difficult. its success clearly depends on the commitment of each country. it is important to understand that the scenarios discussed above can also be considered as steps. harmonization is a moving process and harmonization initiatives evolve over time. for example: jj this central system is supported by the national dras that also continue to operate their own registration systems for products limited to national markets. • the european model was initiated to stop war between its countries (scenario 2), but has in the time since evolved to an integration model to create further economic and political bonds ( scenario 1). • asean is another evolving initiative that may follow the european model. today, it is between scenario 1 and 2. this evolution to a more integrated model is obviously easier when the members are somewhat limited in number and share common geographical, historical, and cultural roots. it is indeed very difficult to imagine that apec or pandrh will evolve towards integration models such as europe or asean. the european community was created after world war ii in order to develop a more peaceful europe by promoting cooperative projects. since then, it has rapidly evolved to become a unique partnership between 28 european countries. the main goal of the community is the progressive integration of member states' economic and political systems, and the establishment of a single european market based on the free movement of goods, people, money, and services. the european union (eu) is not a federation like the united states of america (us), nor is it simply an organization for cooperation between governments like the united nations. it is, in fact, unique in that the countries that make up the eu (its "member states") remain independent sovereign nations, but pool their sovereignty in order to gain a strength and world influence that none could have on their own. kk with approximately 500 million people (representing 7% of the world's population), the eu is today the world's third largest population after china and india, representing a huge single market. the eu's gross domestic product (gdp) is now bigger than that of the us, and it is the world's biggest exporter and importer [98] . diversity is an important characteristic of the eu as symbolized by its motto, "united in diversity," with many differences existing among its member states. this diversity is a positive attribute of the union. however, considering the 24 official languages and the major historic, social, cultural, and economic differences between member states, its development has not been easy. its diversity has also influenced its organization and the way the harmonization process has been structured. it is therefore very important to understand the history and organization of the eu in order to understand how the european pharmaceutical regulation has been structured over time. effectively alone and where cooperative action at the community level is indispensable. these include major health threats and issues with a cross border or international impact, such as pandemics and bioterrorism, as well as issues relating to free movement of goods, services, and people. acknowledging that all countries share common values (i.e., ensure high standards of public health and equity in access to quality healthcare), it is therefore logical that the eu has developed common standards for medicines. moreover, the implementation of a single market requires harmonization of the pharmaceutical market. the ability to travel freely, or to live and work anywhere in the eu, only makes sense if eu citizens can be sure to obtain the same level of healthcare wherever they go. therefore, a number of european community rules have been adopted to ensure the highest possible degree of protection of public health while promoting the free movement of medicines in an internal market without barriers. the european commission (ec)'s role is not to mirror or duplicate national activities, but to coordinate them. work on healthcare at the community level adds value to member states' actions, particularly in the area of illness prevention, including activity on the safety and efficacy of medicines [99] . today, the european pharmaceutical system is well developed and the vast majority of requirements have been harmonized. this successful european cooperation in pharmaceuticals is also recognized on a worldwide basis due to its major contribution to the global harmonization of pharmaceutical regulations (via its active involvement in international initiatives such as ich and who). today the eu is composed of 28 member states, but the size of the eu has changed over time as it has continually expanded since european integration first began in 1951 with only six countries ( table 4 ). the final three enlargements (in 2004, 2007, and 2013 ) expanded the eu member states from 15 to 28, and were rooted in the collapse of communism. it was a historic advancement that offered an unexpected and unprecedented opportunity to extend the union into central and eastern europe. today, the landmass of the eu covers 4 million km 2ll and can rightly claim to represent a continent (plate 1). stretching from the atlantic ocean to the black sea, it reunites western and eastern europe for the first time since they were separated by the cold war. in the future, the eu will continue to grow as an increasing number of countries express interest in membership. the treaty on european union sets out the conditions for such accession (articles 6 and 49): any european country which respects the principles of liberty, democracy, respect for human rights and fundamental freedoms, and the rule of law may apply to become a member of the union. the applicant country must meet a core of criteria (e.g., having stable institutions and a functioning market economy) in order to ensure that eu principles will be respected and that eu rules and procedures will be effectively implemented. this is a long and rigorous process that starts when the country submits an application to the council. today, iceland, the former yugoslav republic of macedonia, montenegro, turkey, albania, bosnia and herzegovina, kosovo, and serbia are candidates to join the eu, some of these countries being in more advanced stages of negotiation with the eu than others. membership is only granted when the necessary requirements are met and when candidate countries have demonstrated that they will be able to fulfill their part as members. in the eu regulatory network. for example, the ipa program supported the participation of nominated representatives of the concerned countries in selected meetings and training courses as observers. the program also supported the organization of conferences to prepare the countries for integration into the european regulatory network for medicines. these activities helped identify areas where additional action might be needed to ensure the smooth transposition of the eu "acquis communautaire" mm into the national legislation of these future eu member states. ▸ the specific case of iceland, liechtenstein, and norway: in july 2009, iceland submitted its application for eu membership and the accession negotiations have now been opened. norway, despite two failed attempts by referendum to enter the european community in 1972 and the eu in 1994, remains undecided whether or not it will apply once again for eu membership. presently, however, neither norway nor liechtenstein are candidates for eu membership. however, even if these three countries are currently not part of the eu, it is important to note that they have a specific strong relationship with the union through the european economic area (eea) agreement that entered into force on january 1, 1994. this agreement allows these three eea european free trade association (efta) states nn to participate in the eu internal market on the basis of their application of internal market relevant acquis. oo all new relevant community legislation is dynamically incorporated into the agreement and thus applies throughout the eea, ensuring the homogeneity of the eu internal market. also, the eea agreement allows for eea-efta states to participate in the internal market's relevant community programs and agencies, albeit with no right to vote. in the pharmaceutical sector, norway, iceland, and liechtenstein have adopted the complete community acquis on medicines, and are consequently parties to the european procedures. in the case of the centralized procedure, the representatives from these three countries do not vote, but their position is stated separately in the opinion, where relevant, in the minutes of the committee and in the case of divergent opinions appended to the committee's opinion. their position is not counted in reaching the committee's opinion [103] . according to decision no. 74/1999 of the eea joint committee (which entered into force on january 1, 2000), when decisions on approval of medicinal products are accepted by the community, these three countries will accept corresponding decisions on the basis of the relevant acts. the liechtenstein authorities have transposed into their national legislation a provision that makes commission decisions automatically applicable on their territory. however, legally mm "acquis communautaire" is a french term referring to the cumulative body of eu laws, comprising the ec's objectives, substantive rules, policies, and in particular, the primary and secondary legislation and case law -all of which form part of the legal order of the eu. nn the european free trade association (efta) is an intergovernmental organization set up for the promotion of free trade and economic integration to the benefit of its four member states: iceland, liechtenstein, norway, and switzerland. although switzerland has many agreements with the eu, it is today not part of the eea agreement due to the rejection of accession by the swiss people. oo the eea agreement is concerned principally with the four fundamental pillars of the internal market, "the four freedoms" (i.e., freedom of movement of goods, persons, services, and capital). binding acts from the community (e.g., commission decisions) do not directly confer rights and obligations in norway and iceland, but first have to be transposed into legally binding acts in these states [104] . since the end of world war ii, the eu has steadily become more established and organized. the unique european model (not a federation but a more integrated than simple cooperation between governments) requires a complex organization that not only protects the independent sovereignty of the member states, but also allows for the delegation of some of decision-making powers to shared supranational institutions. today, the structure in place was specifically designed to represent the interests of the community, the member states, and the european citizens. within this overall european structure and context, many special domains have been harmonized and organized to support the functioning of the single market. a number of institutions, committees, and technical bodies ( table 5 ) play a significant role in the european pharmaceutical system. the roles and characteristics of these are briefly described in the following sections. ▸ the european parliament is the directly elected eu institution that represents the interests of the eu's citizens. its 766 members are elected once every five years. its origins go back to the 1950s and the founding treaties, but the lisbon treaty significantly increased its role in the decision-making process and budget approval. its legislative powers were reinforced by the extension of the co-decision procedure. today the european parliament is firmly established as a co-legislator, has budgetary powers, and exercises democratic control over all the european institutions. its work is organized through a system of specialized committees that review and prepare legislative proposals and reports to be presented at the plenary assembly. the committee on the environment, public health and food safety is responsible for the legislation covering pharmaceutical products and the ema. the european parliament has three working locations: brussels (belgium), luxembourg, and strasbourg (france). luxembourg is home to the administrative offices of the general secretariat. meetings of the entire parliament, known as "plenary sessions," take place in strasbourg and sometimes in brussels. committee meetings are also held in brussels. ▸ the council of the european union represents the individual member states. it meets in different configurations and is attended by one minister from each of the eu's national governments (depending on the agenda). health-related discussions are handled by the employment, social policy, health and consumer affairs council (epsco). as with the european parliament, the council was set up by the founding treaties in the 1950s. it is a key decision-making body that, among other responsibilities (e.g., coordination of the eu's economic policies and foreign and security policy) shares lawmaking and budgetary powers with the european parliament. its work is facilitated by the committee of permanent representatives (coreper), which is responsible for preparing the work of the council of the european union (all issues must pass through coreper before they can be included in the agenda for an eu council meeting). this committee consists of the member states' ambassadors to the eu. these permanent national representatives and their team are located in brussels, belgium, and protect national interests at the eu level. ▸ the european commission (ec) is independent of national governments as it represents and upholds the interests of the eu as a whole. it acts as the "guardian of the treaties" but remains politically accountable to the parliament. like the parliament and council, the ec was set up in the 1950s under the eu's founding treaties. a new commission, which is formed by a president (designated by the member states and approved by the parliament) and the "commissioners" (each of them responsible for a specific policy area), is appointed every five years. its role is to draft proposals for new european laws (which are presented to the european parliament and the council for adoption). it is also the eu's executive arm because it is responsible for implementing the decisions of the parliament and the council. this means managing the day-to-day business of the eu: implementing its policies, running its programs, allocating its funds, and representing the eu in international negotiations. the day-to-day running of the commission is done by its administrative officials, technical experts (via its various committees and groups), translators, interpreters, and secretarial staff (which represent more than 20,000 people). this staff is organized in departments, known as directorates-general (dg), and "services" (such as the legal service). the overall coordination is provided by the secretariat-general. each dg is responsible for a particular policy area and is headed by a director-general who is answerable to one of the commissioners. the regulation of medicinal products was previously under the dg enterprise and industry, but this policy area has been transferred to the dg health and consumers (sanco) as of march 1, 2010. the commission is based in brussels (belgium), but it also has offices in luxembourg, representation in all eu countries, and delegations in many capital cities around the world. this "institutional triangle" produces the policies and laws (such as european pharmaceutical legislation) that apply throughout the eu. the court of justice upholds the rule of these european laws and makes sure that this eu legislation is interpreted and applied in the same way in all eu countries. the other institutions of the eu (the european council and the court of auditors) are critical for the functioning of the eu, but are not directly involved with the development and harmonization of pharmaceutical legislation. the eu institutions are supported by a number of other bodies (e.g., the european central bank, the european ombudsman, etc.). specialized agencies (e.g., the ema, the european centre for disease prevention and control, and the executive agency for health and consumers) have also been established to handle certain technical, scientific, or management tasks. this agency is headed by an executive director (who is its legal representative responsible for all operational and staffing matters) and has a staff of about 900 full-time members [107] . the management board is the supervisory body responsible for setting the agency's budget, approving the annual work program, and ensuring that the agency works effectively and cooperates successfully with partner organizations across the eu and beyond. in addition to its staff, the ema is composed of seven committees that conduct the main scientific work of the agency. these committees and their characteristics are reviewed below: • human use. the chmp plays a vital role in the eu marketing procedures as it is responsible for: -conducting the initial scientific assessment and issuing opinions on an maa for medicines registered via the centralized procedure (these opinions are used by the ec as a basis for its legally binding decisions) -coordinating post-marketing activities for medicines registered via the centralized procedure -arbitrating disagreements between member states during mutual recognition and decentralized procedures (arbitration procedure) -acting in referral cases, initiated when there are concerns relating to the protection of public health or where other community interests are at stake (community referral procedure) this committee (and its working parties) also provides assistance to companies during development, prepares scientific and regulatory guidelines, and cooperates with international partners on the harmonization of regulatory requirements for medicines. • the committee for orphan medicinal products (comp), established by regulation (ec) no 141/2000, is charged with reviewing applications from companies seeking "orphan medicinal product designation" for products they intend to develop for the diagnosis, prevention, or treatment of rare diseases (so-called "orphan drugs"). this committee is also responsible for advising the european commission on the establishment and development of a policy on orphan medicinal products in the eu, and assists the commission in drawing up detailed guidelines and liaising internationally on matters relating to orphan medicinal products. • submitted by pharmaceutical companies, and to adopt opinions on these plans. this includes assessing applications for full or partial waivers and assessing applications for deferrals of pediatric studies. this committee also assesses data generated in accordance with the agreed-upon pips, provides opinions on the quality, safety, or efficacy of a medicine for use in the pediatric population (at the request of the chmp or a member state), and supports the development of the european network of pediatric research at the european medicines agency (enpr-ema). ss • the committee for advanced therapies (cat) is a multidisciplinary committee established in accordance with regulation (ec) no 1394/2007. it is responsible for providing scientific opinions on advanced-therapy medicinal products (atmps) and any scientific questions related to this field. for example, it prepares a draft opinion on each atmp application before the chmp adopts a final opinion on the granting, variation, suspension, or revocation of a marketing authorization for the medicine concerned. • the committee for medicinal products for veterinary use (cvmp) is responsible for preparing the agency's opinions on all questions concerning veterinary medicinal products. • the pharmacovigilance risk assessment committee (prac) is the last committee established by the ema to implement the new eu pharmacovigilance legislation. it is responsible for assessing and monitoring safety issues for human medicines. this includes the detection, assessment, minimization, and communication relating to the risk of adverse reactions, while taking the therapeutic effect of the medicine into account. it also has responsibility for the design and evaluation of post-authorization safety studies and pharmacovigilance audits. its recommendations are considered by the chmp when it adopts opinions for centrally authorized medicines and referral procedures, and by the cmdh when it provides a recommendation on the use of a medicine in member states. these ema scientific committees are comprised of members of all eu and eea-efta states (iceland, liechtenstein, and norway); some committees include patients' and doctors' representatives. they are supported by a number of working parties and related groups that have expertise in a particular scientific field. the committees consult with them on scientific issues relating to their particular field of expertise and delegate to them certain tasks associated with the scientific evaluation of an maa or drafting and revision of scientific guidance documents. in particular, the chmp is supported by an important number of groups (i.e., the biologics working party, the scientific advice working party, or the numerous scientific advisory groups specialized by therapeutic area); some are standing parties and some temporary groups. all these groups are made up of members selected from the european expert list maintained by the ema. indeed it is worth noting that the ema evaluation system works through a network of european experts made available to the agency by the national dras of all eu member states and of the three eea-efta states (iceland, liechtenstein, and norway). this system brings together the scientific resources and expertise of all these countries in a network of over 4,500 european experts who serve as members of the agency's scientific committees, working parties, or scientific assessment teams. the ema is today considered as the model of fruitful cooperation between national dras, working together within a community body to serve community purposes. also, to ensure that the european system is accessible to everyone, in 2005 the ema launched a dedicated office to provide special assistance to small-and medium-sized enterprises ( -for the collection, preparation, storage, distribution, and appropriate use of blood components in blood transfusions -for the transplantation of organs, tissues, and cells the role of the edqm is essential in europe in facilitating mutual recognition of quality control tests carried out on medicines and ensuring that patients receive the same quality of pharmaceutical products throughout europe. there is a substantial amount of interaction between the ema and the edqm. for example, the edqm representatives participate as observers of the ema's quality working party (qwp) and biologics working party (bwp) meetings, the gmp inspection services group meetings, as well as hmpc meetings at the ema. it is important to note that the european member state plays a significant role in the european pharmaceutical system. the ema works closely with the 28 eu member states as well as the eea-efta countries (norway, iceland, and liechtenstein). member state representatives are members of the agency's management board while the agency's scientific committees and its network of 4,500 scientific experts are nominated by the member states. without their support and expertise, the ema would be unable to deliver on its responsibilities and mandate as laid down in european legislation. it is also important to realize that many medicines available in europe are not authorized by the ec on the recommendation of the ema. many products are still approved and supervised by the national dras via the mutual recognition procedure, the decentralized procedure, or national procedure. to coordinate their efforts, the member states established the heads of medicines agencies (hma) group, which is a network of the heads of the national dras. this hma is comprised of more than 40 national agencies, some also having responsibility for veterinary products, medical devices, and cosmetics, and also pricing and reimbursement of products. the ema is also a member of the hma. the first meeting of the hma took place in amsterdam (the netherlands) at schiphol airport, on february 20, 1996. the hma is focused on eu coordination and harmonization, decision making, and consensus on strategic issues of the european medicines regulatory network. its aim is to foster an effective and efficient european medicines regulatory system. more specifically, it works towards the following key objectives [111]: ▸ addressing key strategic issues for the european medicines regulatory network, such as the exchange of information and sharing of best practices ▸ collectively being responsible for all areas of medicines regulation, including the mutual recognition and decentralized procedures ▸ focusing on the development, coordination, and consistency of the network ▸ supporting the network by providing high-quality professional and scientific resources ▸ providing a focus for making the most effective use of scarce resources across the network, such as developing and overseeing arrangements for work sharing to fulfill these objectives, the hma has been working on both general issues (i.e., strategy for telematics, and regulatory and scientific training) and technical and scientific topics (i.e., harmonization of clinical trials, coordination of products testing, and european risk management strategy) is support of the european medicines regulatory network. the hma's website contains the mri product index database, which includes all medicines approved in the member states according to the mutual recognition procedure. one interesting program that has been developed is the benchmarking of european medicines agencies (bema). the bema program assesses the systems and processes in individual agencies against a set of agreed-upon indicators. this is a good opportunity to exchange best practices and ensure harmonization of practices (i.e., assessment, inspection, etc.) between regulators within the network. coordination among the national competent authorities is not a simple task due to the heterogeneity of these national organizations. indeed, these authorities differ in size, historic origins, roles, resources, expertise, and funding. acknowledging these differences and also the legal, scientific, social, political, and financial challenges facing the network, the hma adopted a strategic paper that provides a plan of action for 2011-2015 [112] . this second plan (the first one covered 2006-2010), highlights a number of key themes and areas of focus (i.e., pharmacovigilance, clinical trials, and communication) and also the need for international cooperation. the hma is supported by the heads of medicines agencies management group, the permanent secretariat, and working groups covering specific areas of responsibility. iceland, and liechtenstein) appointed for a renewal period of three years. observers from the european commission and accession countries also participate in the meetings. it also has many interactions with the ema to facilitate harmonization in several areas (i.e., pediatric regulation, variation regulation, and pharmacovigilance). it holds monthly meetings at the ema (which also provides the secretariat of the cmdh). in practice, approximately half of the time of the cmdh meeting is dedicated to discussions on procedural and regulatory issues, development of guidance documents, and oversight of the activities of the various cmdh subgroups and working groups, while the other half is devoted to trying to reach agreement for applications referred to the cmdh in the case of disagreement between member states. the gradual harmonization of pharmaceutical regulation in the eu has been dictated by the development and expansion of the community. it represents a good example of successful harmonization and also demonstrates the influence of the political and economical decisions on the harmonization process and its outcomes. ▸ the birth of the european union: the historical roots of the eu lie in world war ii. following this bloody, horrific war, several leaders in europe wanted to ensure that war could never happen again. their goal was to develop a peaceful europe and to stop the frequent wars via the promotion of cooperative projects. this initiative has been critical but not easily accomplished due to the post-war geopolitical situation and the beginning of the 40-year-long cold war that split europe into east and west. on september 19, 1946, winston churchill called for a "kind of united states of europe" in a speech given at the zurich university. many attempts at cooperation were made in the following years (e.g., the customs convention between belgium, luxembourg, and the netherlands, and the organization for european economic cooperation). in 1949, west european nations created the council of europe. uu it was a first step towards cooperation between them, but some countries wanted to go ever further. on may 9, 1950, france's foreign minister robert schuman presented a plan for deeper cooperation and for the creation of an organized europe, which would prove indispensable to the maintenance of long-term peaceful relations. this proposal (known as the "schuman declaration") is considered to be the beginning of the creation of what is now the eu. may 9 has since been designated as "europe day" to celebrate this event. the idea of this plan (inspired by jean monnet, top advisor of the french government) was to promote european peace by (1) eliminating the age-old opposition of france and germany, and (2) creating a framework and organization open to the participation of the other countries in europe. it proposed that the franco-german production of coal and steel be placed under a common high authority and that this new productive unit be open to all european countries willing to participate. the double objectives of this proposal were (1) to set up common foundations for economic development as a first step in the federation of europe, and (2) to make war materially impossible [113] . based on the schuman plan, six countries (germany, france, italy, the netherlands, belgium, and luxembourg) signed the treaty of paris on april 18, 1951 to establish the european coal and steel community (ecsc) in order to run their coal and steel industries under a common management. it is important to note that the independence and the powers of the high authority have been critical, and differentiated the eu from other traditional intergovernmental organizations. indeed, the establishment of the ecsc was the first step towards a supranational europe. for the first time the six member states of this organization relinquished part of their sovereignty, albeit in a limited domain, in favor of the european community. building on the success of their first treaty, the six countries decided to expand cooperation to other economic sectors. on march 25, 1957, under belgian minister for foreign affairs, paul-henry spaak, they signed the treaty of rome, establishing the european economic community (eec) (or "common market") allowing persons, goods, services, and capital to move freely across borders. the same day, they also signed a second treaty to create the european atomic energy community (euratom). despite the construction of the berlin wall in august 1961, which increased the division between the east and the west, the cooperation between european countries continued to increase in different areas (e.g., food and agriculture, aerial navigation, the environment, etc.). on july 1, 1968, the six countries created the world's largest trading group by removing customs duties on goods imported from each of the six countries to the others, allowing free cross-border trade for the first time. they also applied the same duties on their imports from outside countries. this eu internal market was reinforced in 1986 with the adoption of the "single european act" (which entered into force on july 1, 1987) to remove the final obstacles. in 1993, the single market and its four freedoms (movement of goods, services, people, and money) had finally been fully established. additional agreements, such as the schengen agreement in 1995, have since been signed to further facilitate movement within europe. today, this single market represents the core of the eu. in 1991, following the collapse of communism across central and eastern europe and the dissolution of the pacte de varsovie, a decade began that would be critical for the future of europe. on december 13, 1997, eu leaders agreed to start the process of membership negotiations with 10 countries of central and eastern europe (bulgaria, the czech republic, estonia, hungary, latvia, lithuania, poland, romania, slovakia, and slovenia). the mediterranean islands of cyprus and malta were also included. in december 2000, treaty changes agreed to in nice (france) and finally signed on february 26, 2001 were entered into force on february 1, 2003 and opened the way for enlargement of the eu by reforming its institutions and voting rules. this enlargement to the eastern european countries became effective on may 1, 2004 and january 1, 2007. six years later, on july 1, 2013, the accession of croatia brought the number of member states to 28 countries. a single currency (euro [€]) was introduced on january 1, 1999 in 11 countries (joined by greece in 2001) for commercial and financial transactions only. notes and coins were introduced in january 2002. this introduction of the single currency followed a long stepwise process that started in the 1970s with the creation of the "exchange rate mechanism" to maintain monetary stability. the next important step of integration (i.e., development of a political union with fully functioning institutions) took time and faced many challenges. the debate on the "constitutionalization" of europe started in 1984 when the european parliament adopted altiero spinelli's report proposing, in a "draft treaty on european union," a fundamental reform of the european community. in the 1990s, two important treaties transformed the community: ▸ the treaty on european union (signed in maastricht [the netherlands] on february 7, 1992, entered into force on november 1, 1993) represented a new stage in european integration as it opened the way to political integration. it was a major eu milestone, introducing the concept of european citizenship and setting clear rules for the future single currency and for foreign and security policy. under the treaty, the name "european union" officially replaced "european community." ▸ the treaty of amsterdam (signed on october 2, 1997, entered into force on may 1, 1999), built on the achievements of the treaty from maastricht, laid down plans to reform eu institutions, gave europe a stronger voice in the world, and concentrated more resources on employment and the rights of eu citizens. building on this transformation of the community, the adoption of a european constitution and major institutional reform became an important topic of discussion for two reasons: ▸ succeeding treaties have spurred progress in the building and reforming of europe and its institutions. this long process marked by ever-closer integration progressively transformed europe from an economic community to a political union. ▸ the combination of the various treaties and protocols signed over 50 years has made the european structure and legislation more and more complex. although the eu will certainly continue to grow, it is difficult to predict the next steps of integration due to the current geopolitical situation and the instability caused by the financial crisis. the evolution of pharmaceutical regulation harmonization and cooperation in europe represents an excellent example and model that needs to be analyzed in detail as it shows the different important steps necessary for harmonization success. a large body of legislation has been developed, with progressive harmonization requirements since the 1960s. the first european directive related to pharmaceutical products (directive 65/65/eec [114]) was signed on january 26, 1965. this text provides the european definitions of a "medicinal product" and a "substance" and set up some fundamental principles for the creation of the european pharmaceutical system such as: ▸ no medicine may be placed on the market of a member state unless a marketing authorization has been issued by the competent authorities following the review of an application submitted by the person responsible for placing that product on the market. ▸ quality, safety, and efficacy are the basis for the evaluation of an application by the competent authorities. ▸ the information included in the application should be updated on a regular basis. following this first directive, many texts followed over the years to further detail the european principles and requirements led by directive 65/65/eec, to organize and structure the european system, and to add new requirements related to specific types of products or emerging problems. major texts and important steps in the development of the european pharmaceutical system are discussed below. however, it is important to note that many other legislative texts, guidelines, and other recommendations (including harmonized quality, and nonclinical and clinical requirements) have been prepared and released over the years to support the major legislatives texts listed in this section. directive 65/65/eec was complemented by two additional directives (directives 75/318/eec and 75/319/eec) in may 1975 to provide further details on the analytical, nonclinical, and clinical standards and protocols to be applied during the development of medicines, and how the results of such studies should be presented in the maa. directive 75/319/eec also established the idea of expert reports (that would later influence the structure of the ctd), the cpmp (that would later be part of the ema), and the first multi-state licensing procedure, which would then evolve progressively to become the current mutual recognition procedure (mrp). further clarification of requirements was provided by directive 83/570/eec (which also modified the multi-state licensing procedure to facilitate its use), and directive 87/21/ eec (which established the notion of combination products and created a route for abridged applications in case of generics and literature-based applications). in 1987, directive 87/22/eec established the concertation procedure, which provided a simple community-wide licensing opinion (via a mandatory referral to the cpmp) for all new biotechnology products and optionally for high technology medicinal products [115] . it was an important new step in building the european pharmaceutical system as this new procedure (the forerunner of the current centralized procedure) required further cooperation between national dras compared to the multi-state licensing procedure previously established. however, both procedures were still based on voluntary cooperation between the relevant national authorities, and each member state remained solely responsible for granting the marketing authorization. in 1989, legislators extended the scope of the previous directives to specific types of products: vaccines, toxins or serums, and allergens (directive 89/342/eec); radiopharmaceuticals (directive 89/343/eec); and products derived from human blood or human plasma (directive 89/381/eec). additionally, on april 23, 1990, directive 90/219/eec laid down the first common measures related to genetically modified organisms (gmos); several additional texts have since then been released on this topic over the years. finally, extension of the scope of the harmonization of homeopathic products was only made in 1992 via the adoption of directive 92/73/eec. in 1991, directive 91/356/eec, which laid down the principles and guidelines of gmp, was adopted. in 1992, four new directives covering the distribution of medicines were adopted to further establish the eu internal market and facilitate the free movement of products. they especially harmonized wholesale distribution (directive 92/25/eec), the classification of products as subject to medical prescription or not (directive 92/26/eec), the labeling of products (directive 92/27/eec), and advertising principles (directive 92/28/eec). despite all these texts adopted since 1965, the resulting progress of completing the single market in pharmaceuticals was not satisfactory. it was therefore decided to fundamentally improve the authorization procedures. a new european pharmaceutical system was then created in 1993 (but only implemented in january 1995). this new system, still in place today, is based on two major texts that established, for the first time, "european decisions" binding to the member states: ▸ following the adoption of these european procedures, it was necessary to harmonize the system to vary the terms of marketing authorization. this was done via the adoption of two regulations in 1995: regulation 541/95 (for the mrp) and regulation 542/95 (for the centralized procedure). additionally, acknowledging the increased complexity of the european pharmaceutical legislation, it was agreed to assemble all previous directives in one single text. this codifying directive, directive 2001/83/ec adopted on november 6, 2001, was necessary because all the directives adopted since 1965 had been frequently and substantially amended. therefore, this directive regroups all legal requirements agreed-upon since 1965 (except requirements and legal provisions provided by regulation 2309/93). this new directive has already been amended several times since its adoption, some of these amendments being the result of a major general review of the legislation and system discussed below. in 2000, as directed by regulation 2309/93 (article 71), the commission conducted a major review of the operation of the new system implemented in 1995. the goal of this audit, contracted out to independent auditors, was to review the extent to which the results achieved over the first five years have met the objectives (namely to enhance the creation of a single market in medicinal products, while ensuring the protection of public health and the development of the pharmaceutical industry). the audit report [116] , known as the "cameron mckenna andersen report," includes the results of the extensive consultation carried out involving individual companies, all dras responsible for the authorization of medicines and the emea, patient and professional associations, trade associations, and relevant ministries. this audit highlighted the overall satisfaction with this new system, as both procedures had been perceived as contributors in both a qualitative and quantitative way to create a harmonized european community pharmaceutical market. ninety-two percent (92%) of companies and 97% of dras in the eu were satisfied or very satisfied with the centralized procedure. there was also general recognition of the very considerable contribution made by the emea and the eu telematics strategy to the successful operation of the system. however, this report also identified several issues and listed several possible improvements to the system. these criticisms were primarily directed towards the mpr for which it was agreed that the lack of real supervisory, management support, and liaison between member states had altered the application of the central principle of mutual recognition. concerned member states were continuing to assess applications. regarding the centralized procedure, it was felt that it should be opened up to a broader range of products and that the "decision-making process" of the commission (post-cpmp opinion) should be reduced and improved. finally, it was also interesting to note that the european procedures had not yet produced any real dividends in terms of cost efficiencies through economy of scale. there was also a need to reduce the administrative burden where there were no public health implications (e.g., in relation to minor variations to existing approvals). this evaluation of the regulatory processes was not only very timely with the emerging technical challenges (e.g., gene therapies, etc.), but also with the political challenges in preparation for eu expansion [117] . indeed, there was little doubt that the upcoming major enlargement of the eu (in 2004, and involving 10 additional countries) would accentuate the weaknesses of the system if both the structural and process issues were not resolved by then. based on this review of the eu pharmaceutical legislation and various public hearings, the ec concluded that on the whole the system had proven appropriate and suitable for its purpose and therefore it was recommended that it keep its main principles and structures. however, the ec also proposed several adaptations of the system and legislation in order to better achieve four major objectives [118]: ▸ assure a high level of public health protection, notably by increased supervision of the market through the strengthening of inspection procedures and of pharmacovigilance. ▸ complete the single market for pharmaceutical products, taking into account the stakes of globalization, and establish a regulatory and legislative framework that favors the competitiveness of european industry. ▸ respond to the challenges of the future enlargement of the eu. ▸ rationalize and simplify the system and improve its overall coherence and visibility and the transparency of its procedures. these proposals, such as opening up the centralized procedure to a broader range of products, establishment of a fast track procedure and conditional authorization, improvement of the transparency of the system, strengthening pharmacovigilance and supervision requirements, abolition of the renewal, control of the effective use of marketing authorization with the "sunset clause," improvement of the decision-making process after cpmp opinion, re-organization and increase of the role of the emea and its committees, major modifications to the mrp and creation of the decentralized procedure, and harmonization of data protection periods [119,120], have been further debated with the parliament and the council over subsequent years. most of them have finally been implemented via the adoption of new or revised legislation and/or guidelines. one of the major legislative impacts has been the adoption of regulation ( finally, in addition to these critical texts that created the european system and general requirements, it is worth mentioning the following additional legislative texts adopted over the past 10 years on important specific subjects (see part i-2. the current european pharmaceutical system has progressively developed over the years via the adoption of agreed-upon policies. since 1985 many texts have been adopted with the aim of achieving a single market for pharmaceutical products. as noted above, several european institutions and technical bodies, together with the eu member states, are involved in the harmonization of european pharmaceutical regulation. the european harmonization process lies in the adoption of eu laws [121] that can be categorized as follows: ▸ the "primary" legislation: the treaties are binding agreements between eu member countries. they state eu objectives, rules for eu institutions, how decisions are made, and the relationship between the eu and its member states. they also form the basis or ground rules for all eu actions. this means that every action taken by the eu is founded on treaties that have been approved voluntarily and democratically by all eu member countries. for example, if a policy area is not cited in a treaty, a law cannot be proposed in that area. ▸ the "secondary" legislation: this is derived from the principles and objectives set out in the treaties. it includes the following texts: • regulations are the most direct form of eu law. as soon as they are passed, they have binding legal force throughout every member state and must be applied in its entirety across the eu. national governments do not have to take action themselves to implement eu regulations (i.e., regulations do not require any transposition by the national authorities). • directives are legislative acts that set out a goal that all eu countries must achieve. national authorities have to adapt their laws to meet these goals, but are free to decide how to do so. vv directives are used to bring different national laws in line with each other, and are particularly common in matters affecting the operation of the single market (e.g., product safety standards). they may concern one or more member states, or all of them. • decisions are individual acts relating to specific cases and are addressed to specific parties. they are binding only on those to whom they are addressed (e.g., an eu country or an individual company), and are directly applicable (no need for implementation into national law). decisions can come from the eu council (sometimes jointly with the european parliament) or the ec. vv each directive specifies the date by which the national laws must be adapted (giving national authorities room to maneuver within the deadlines necessary to take account of differing national situations). • recommendations are not binding, but allow the institutions to make their views known and to suggest a line of action (without imposing any legal obligation on those to whom it is addressed). • opinions are not binding. they are an instrument that allows the institutions to make a statement in a nonbinding fashion; in other words, without imposing any legal obligation on those to whom it is addressed. they can be issued by the main eu institutions (commission, council, parliament), the committee of the regions, and the european economic and social committee. the european parliament and the council of the eu share legislative power, which means they are empowered to adopt european laws (directives and regulations). in principle, it is the commission that proposes new "legislative texts," ww but it is the parliament and council that adopt them. the commission and the member states then implement them, and the commission ensures that the laws are correctly applied. the vast majority of european laws are adopted jointly by the european parliament and the council using a procedure known as "co-decision." xx this means that the directly elected european parliament has to approve eu legislation together with the council (the governments of the 28 eu countries). in addition to this "ordinary legislative procedure," there are also other special legislative procedures (which apply only in specific cases) where the parliament has only a consultative role. the requirements and procedures for the marketing authorization of medicinal products, as well as the rules for variations to the terms of marketing authorizations and for the constant supervision of products after they have been authorized, are primarily laid down in directive 2001/83/ec and regulation (ec) no 726/2004 (and their subsequent amendments). these texts additionally lay down harmonized provisions in related areas such as the manufacturing, wholesaling, or advertising of medicinal products for human use. in addition, various laws have been adopted to address the particularities of certain types of medicinal products and promote research in specific areas. in addition to the legal texts, many additional community or international documents and recommendations have been developed and support the harmonization and cooperation in the eu. the "introduction and general principles" of annex 1 of directive 2001/83/ec, as ww the european commission is the only institution empowered to initiate legislation. before proposing a new text, it assesses the potential economic, social, and environmental consequences that they may have by preparing "impact assessments" (which set out the advantages and disadvantages of possible policy options) and by consulting interested parties. the commission will propose action at the eu level only if it considers that a problem cannot be solved more efficiently by national, regional, or local action. this principle of dealing with things at the lowest possible level is called the "subsidiarity principle," and has been reaffirmed in the lisbon treaty. xx the co-decision procedure was introduced by the maastricht treaty on european union (1992) , and strengthened and made more effective by the amsterdam treaty (1999) . with the lisbon treaty that took effect on december 1, 2009, this procedure has been renamed "ordinary legislative procedure" and has become the main legislative procedure of the eu's decision-making system. amended, acknowledged these scientific and technical recommendations (i.e., "the rules governing medicinal products in the european community," ich guidelines, and monographs of the european pharmacopoeia). all community rules in the area of medicinal products for human (and veterinary) use are compiled in "the rules governing medicinal products in the european union" (eudralex), published by the ec. volume 1 of this publication contains the body of the eu pharmaceutical legislation (i.e., regulations, directives, decisions, etc.). the subsequent volumes include guidelines yy developed to support this basic legislation: zz ▸ volume 2 (also known as "notice to applicants"), first published in 1986, contains all regulatory guidelines related to procedural and regulatory requirements (i.e., the presentation and content of the dossiers), and also the application forms. it was prepared and is regularly updated by the european commission in consultation with competent authorities of the member states and the ema. this notice has no legal power. in case of doubt, therefore, reference should be made to the appropriate community directives and regulations. also, in july 2012, the information contained in chapter 7 of volume 2a (concerning general information on procedures for marketing authorization) was transferred to ema and cmdh websites. ▸ volume 3 consists of all the scientific guidelines for medicinal products for human use prepared by the committee for medicinal products for human use (chmp) in consultation with the competent authorities of the eu member states. the guidelines are intended to provide a basis for practical harmonization in the manner in which the eu member states and the ema interpret and apply the detailed requirements for the demonstration of quality, safety, and efficacy contained in the community directives. an updated list of scientific guidelines is accessible on the ema website. ▸ volume 4 contains guidance for the interpretation of the principles of gmps for medicinal products for human and veterinary use. ▸ volume 9 contained pharmacovigilance guidelines for medicinal products for both human use (volume 9a) and veterinary use (volume 9b). volume 9a was replaced by the ema "guidelines on good pharmacovigilance practice (gvp)" in 2012 [122] . ▸ volume 10 contains guidance documents applying to clinical trials. finally, in addition to the published rules listed above, a lot of other documents that do not have the status of a law or guideline (i.e., questions and answers [q&a], recommendations, public statements, position papers, reflection papers, etc.) are released by the ema to provide additional guidance. moreover, templates (e.g., assessment templates and guidance), internal standard operating procedures (sops), work instructions (wins), and policy covering both general and specific topics (e.g., pharmacovigilance, inspection, etc.) have been developed by the ema to improve consistency in activities and evaluations and to help ease the exchange of information. many technical requirements have been harmonized and published in europe to ensure that medicinal products throughout europe are of equal quality, safe, and efficacious. these are the three basic criteria that are always evaluated and taken into consideration when establishing the risk and benefit ratio. these criteria are evaluated through the quality, nonclinical, and clinical information included in all applications. of course, the level of quality/nonclinical/clinical documentation varies depending upon the type of products and the level of development, but they are always the basis of approval for the registration of a clinical trial or a new product. legal provisions related to these technical requirements are included in annex 1 of directive 2001/83/ec and other relevant regulations or directives. in addition, scientific and technical guidelines are also prepared by the ema's committees (i.e. chmp, comp, pdco, etc.) and its working parties (in consultation with the competent authorities of the eu member states). guidelines developed by other technical bodies (e.g., the european pharmacopoeia) or international bodies are also used in europe. for example, europe is a founder and member of ich, and therefore all ich guidelines are also applicable in europe. ▸ quality: many european requirements are in place regarding the quality of the products (active substance, excipients, and finished products). detailed scientific guidelines have been developed to adequately cover pharmaceutical development, manufacture, packaging, control (i.e., specifications, analytical procedures and validation, and impurities), stability evaluation, and post-approval changes. moreover, guidelines for certain types of products (i.e., biologics, radiopharmaceuticals, medicinal gases, or herbal medicinal products) have been specifically released to take into account their specific challenges. these technical and scientific guidelines, together with the q&a document, provide a common interpretation of the european legislation and ensure harmonization of quality requirements. also, in addition to these guidelines, it is worth mentioning two other publications that have been critical in the harmonization of the quality aspect of medicinal products available on the european market: • good manufacturing practice (gmp) is one of the most important harmonized requirements that have been issued. as per directive 2001/83/ec and directive 2001/20/ec, all products (including investigational medicinal products) have to comply with the principles and guidelines of gmp. these gmp principles are laid down in directive 2003/94/ec. in addition, the ec has published detailed gmp guidelines in line with those principles in eudralex (volume 4). this volume covers both the basic requirements for medicinal products (part i) and for active substances used as starting materials (part ii). particular considerations and conditions for specific products (biological products, radiopharmaceuticals, medicinal gases, products derived from human blood or plasma, herbal medicinal products, excipients, etc.) are also in place or under discussion. under this eu system, manufacturers and importers of medicines located in the eea are subject to a manufacturing authorization and come under the supervision of the competent authorities of the member states (the supervisory authorities), who are responsible for issuing the authorizations for those activities taking place in their territories. • the european pharmacopoeia (ep), established on july 22, 1964 by eight countries, aaa is a collection of standardized specifications, so-called monographs, which define the quality reference standard for medicines. today, the convention has been ratified by more than 35 european countries and the eu. european directive 2001/83/ec refers to the mandatory character of ep monographs in the preparation of dossiers for maa in the eu. the ep is also applicable in all the signatory states of the convention for the elaboration of an ep, and is used as a reference by many other countries (there are more than 20 observers). the ep is published by the edqm and covers active substances, excipients, substances or preparations for pharmaceutical use of chemical, animal, human or herbal origin, homoeopathic preparations and stocks, antibiotics, as well as dosage forms and containers. the texts of the european pharmacopoeia also apply to biologicals, blood and plasma derivatives, vaccines, and radiopharmaceutical preparations. ▸ nonclinical: all aspects of nonclinical testing and programs are covered under general guidelines (e.g., glp) bbb or discussions on nonclinical strategies to identify and mitigate risks for first-in-human clinical trials or guidelines specific to a type of testing (i.e., pharmacology, aaa belgium, france, germany, italy, luxembourg, the netherlands, switzerland, and the united kingdom. bbb the principles of good laboratory practice define a set of rules and criteria for a quality system concerned with the organizational process and the conditions under which nonclinical health and environmental safety studies are planned, performed, monitored, recorded, reported, and archived. pharmacokinetics, single and repeat dose toxicity, genotoxicity, carcinogenicity, reproductive and developmental toxicity, and local tolerance). most of these guidelines have in fact been developed under the auspices of ich. as for the quality requirements, specific nonclinical guidelines have also been developed for certain types of products. numerous clinical guidelines are available, which cover all phases of clinical development, from early on (i.e., clinical pharmacology and pharmacokinetics studies) to the design of phase 3 studies (disease and patient characteristics, advice on selection of endpoint, duration, control groups, and choice of comparator, etc.). due to the specificities of each group of products, guidelines have been organized by therapeutic area, and some focus on certain types of products (herbal medicinal products or radiopharmaceuticals and diagnostic agents). additionally, general guidelines have also been released to provide advice on general considerations and topics during drug development that are not disease-specific (e.g., "guideline on missing data in confirmatory clinical trials," "extrapolation of results from clinical studies conducted outside europe to the eu population," "clinical trials in small populations," "data monitoring committee," "choice of a non-inferiority margin," and "excipients in the label and package leaflet of medicinal products for human use"). in addition to these numerous scientific guidelines, it is worth mentioning the development and implementation of gcp in europe for investigational medicinal products. this harmonization of gcp has been critical for the recognition of data between european countries, and therefore cooperation on clinical aspects of drug development. directive 2001/20/ec is the framework legislation that provides for additional directives, accompanying guidelines, and detailed guidance documents. these guidelines and guidance documents are published in eudralex (volume 10). finally, it is important to note that there has been a lot of effort put forth in past years regarding harmonization of the european pharmacovigilance system. this system is coordinated by the ema, but also involves national competent authorities ccc and the european commission. it includes a broad range of activities such as the review of risk management plans (rmps) and psurs, the development and maintenance of the eu reporting and data warehouse system for case reports (eudravigilance), signal-identification activities in the eu, and the coordination of eu rapid alert and incident management systems for timely and adequate responses to new safety data. the eu legal framework of pharmacovigilance was provided in regulation (ec) 726/2004 and directive 2001/83/ec. additionally, relevant ich guidelines have been implemented, and volume 9 of eudralex has been dedicated to this key public health function. it included a number of detailed guidelines, definitions, standards, and information regarding the precise execution of pharmacovigilance-related procedures. ccc in some member states, regional centers are in place under the coordination of the national competent authority. in december 2008, following a public consultation, the ec decided to further harmonize the system (to ensure it is optimally effective, robust, and transparent) via the adoption of two additional texts [123, 124] . the final new legislation [125] was finally published on december 31, in the official journal of the european union. on june 19, 2012, the commission implementing regulation (eu) 520/2012 was adopted, complementing the 2010 pharmacovigilance legislation that started to apply in july 2012. finally, some pharmacovigilance incidents in the union have shown the need for further improvements of the 2010 legislation. these issues have been addressed by directive 2012/26/eu and regulation no 2012/1027/eu, which started to apply in 2013. due to the number and importance of improvements that need to be implemented [126, 127] , many observers consider this new pharmacovigilance legislation as the biggest change to the eu legal framework since the creation of the ema in 1995. the implementation of this new pharmacovigilance legislation required a lot of effort from the ema [128]. this was a major activity because several processes needed to be established or amended (e.g., the establishment of a new pharmacovigilance risk assessment committee [prac] replacing the chmp pharmacovigilance working party). also, an important change of the new legislation is the increased direct involvement of the ema in the pharmacovigilance of nationally authorized products, in addition to the centrally authorized products. for example, the ema has released the "guidelines on good pharmacovigilance practice (gvp)", which replace volume 9 of eudralex [129] . this new set of guidelines applies to all medicines authorized in the eu, whether centrally or nationally authorized. the ema is also working with other groups to continuously improve the safety monitoring of medicines. this includes its central coordinating role in protect, ddd its support of the european network of centres for pharmacoepidemiology and pharmacovigilance (encepp), eee its work with the us fda on ae signal detection activities, and its notifications to the who of any measures taken in the eu on medicines that may have a bearing on public health protection in third-world countries. finally, the heads of medicines agencies have also put in place a multi-annual program (called the european risk management strategy [erms] ) which aims to strengthen european pharmacovigilance systems by putting in place efficient measures allowing for the early detection, assessment, minimization, and communication of a medicine's risk throughout its lifecycle. these guidelines apply to more than one specific area and have been prepared through the collaboration of several working parties. they provide advice and guidance on specific ddd protect is a project of the innovative medicines initiative (imi), which is aimed at strengthening the monitoring of the benefits and risks of medicines in europe by developing innovative tools and methods that will enhance the early detection and assessment of adverse reactions. eee encepp is a network that supports independent, post-authorization studies on the safety and benefit/risk aspects of specific medicines. important topics (i.e., pediatrics, cell therapy and tissue engineering, vaccines, biosimilars, gene therapy, and pharmacogenomics). the eu harmonization activities related to certain of these topics are further discussed in the following sections. it is also important to note that cooperation in the areas of inspection (e.g., gmp, glp, gcp, or phv) is critical. although the responsibility for carrying out inspections rests with the national competent authorities of member states, the coordination of these inspections by the ema (and the agreement of common standards) has been an important step that allows for: • increased cooperation between member states • reduced duplication of work (due to the recognition of inspections performed by other member states) • ensuring the same level of quality of medicinal products, and the data generated during their development, wherever the location of the manufacturing site or studies a european system for the authorization of medicinal products has been created with the objective of ensuring that safe, effective, and high-quality medicines can quickly be made available to all citizens across the eu. today, the european system offers several routes for the authorization of medicinal products: ▸ the centralized procedure (laid down in regulation (ec) no 726/2004) is compulsory for certain types of products: products derived from biotechnology processes, advanced therapy medicines, orphan medicines, or products intended for the treatment of certain specific diseases. for medicines that do not fall within these categories (the "mandatory scope"), companies can also submit an application if the medicinal product constitutes a significant therapeutic, scientific, or technical innovation, or if it is in any other respect in the interest of public health. applications for the centralized procedure are made directly to the ema and lead to european marketing authorization. this authorization, binding in all member states, is granted by the ec (based on the opinion of the relevant ema committee). it is valid for the entire community market, which means the medicines may be put on the market in all member states. this is the ultimate integration model in this domain because there is a single application, a single evaluation, and a single authorization allowing direct access to the single market of the community. ▸ the mutual recognition procedure (mrp) (laid down in directive 2001/83/ec), applicable to the majority of conventional medicinal products, is based on the principle of recognition of an already existing national marketing authorization by one or more member states. should any member state refuse to recognize the original national authorization on the grounds of potential serious risk to public health, the issue is referred to the cmdh to find a consensus. in that case, the cmdh uses its best efforts to reach an agreement on the action to be taken (within the 60-day time period foreseen in the legislation). when this fails, the matter is then referred to the ema/chmp for arbitration (see below for details). at the end of the mrp and decentralized procedure, national marketing authorizations are granted in the member states involved, whereas the centralized procedure results in a single marketing authorization (called a "community marketing authorization") that is valid across the eu, as well as in the eea-efta states (iceland, liechtenstein, and norway). purely national authorizations are still available, but are limited to medicinal products to be marketed in one member state only. in addition to the above registration procedures, another european procedure called "referral" has been established. this community referral procedure is used to resolve disagreements (e.g. between member states during an mrp or a decentralized procedure), address specific concerns relating to the safety or efficacy of a medicine or a class of medicines, or when there is a need to harmonize national decisions across the eu. in a referral procedure, the ema is requested to conduct, on behalf of the european community, a scientific assessment of a particular medicine or class of medicines. the problem is "referred" to the chmp so that the committee can make a recommendation for a harmonized position across the eu. referral procedures can be started by the ec, any member state, or by the pharmaceutical company. at the end of the referral, the committee makes a recommendation, and the european commission issues a decision to all member states reflecting the measures to take to implement the chmp recommendation. finally, it is important to note that, in addition to the harmonization of procedures for the authorization of medicines, the system also ensures harmonization and coordination of the pre-and post-authorization activities: ▸ pre-authorization activities: companies can request scientific advice (or protocol assistance in the case of medicines for "orphan" or rare diseases) from the ema at any stage of medicine development, whether the medicine is eligible for the centralized procedure or not. this european procedure helps the company to make sure that it performs the appropriate tests and studies so that no major objections regarding the design of the tests are likely to be raised during evaluation of the marketing authorization application. ▸ post-authorization regulatory activities (i.e., variations or extensions and transfers of marketing authorizations, renewals, psurs, and notifications) have also been harmonized and are coordinated via the centralized, mrp, or decentralized procedures. this ensures that the same quality, safety, and efficacy of products are maintained during the entire lifecycle management of the products throughout europe (e.g., availability of new formulations, extension of indications, etc.). after years of extensive discussions involving ethical aspects [130] , the european commission adopted a proposal on september 29, 2004 [131] . this proposal led to new legislation (regulation (ec) no 1901/2006) that entered into force in the eu on january 26, 2007. today, this amended text (and its several associated guidelines and other published information) [132] sets up a system of requirements, rewards, and incentives together with lateral measures to ensure that medicines are researched, developed, and authorized to meet the therapeutic needs of children (representing over 20% of the total european population [133]). in practice, this new regulation established an expert pediatric committee (pdco) within the ema, which is responsible for providing opinions on the development of medicines for pediatric use. the key objectives of the regulation are: • to ensure high-quality research in the development of medicines for children aged 0 to 17 years of age • to ensure, over time, that the majority of medicines used by children are specifically authorized for such use • to ensure the availability of high-quality information about medicines used by children in 2008, a communication from the ec (communication 2008/c 243/01) provided guidelines on the format and content of applications for agreement or modification of a pediatric investigational plan. many additional procedural and scientific guidance documents have also been released by the ema to facilitate the implementation of this new regulation. the eu introduced a new orphan medicinal product legislation in 2000 in order to provide incentives for the development of medicinal products for rare disorders. harmonization of requirements for these types of products is critical to allow for multinational clinical studies and to limit the development challenges due to the small number of patients. prior to this european legislation, a number of member states had adopted specific measures to increase knowledge on rare diseases and improve their detection, diagnosis, prevention, and treatment. however, these initiatives were few and did not lead to any significant progress in research on rare diseases. procedure for the designation of orphan medicines with the technical committee for orphan medicinal products (comp), which is responsible for the scientific examination of applications. designated orphan medicines are assessed centrally on a european level by the chmp, rather than in each member state separately. this regulation also put in place incentives for the research, marketing, and development of such products (e.g., fee waivers, a 10-year market exclusivity period postauthorization, and scientific assistance for marketing authorizations). following its entry into force and its associated rules and guidelines, the number of orphan medicines authorized has increased significantly [134] . this directive's aim is to protect public health while securing the free movement of herbal medicines within the community. while most individual herbal medicines will continue to be licensed nationally by member states, the process for licensing and information on herbal substances and preparations will be increasingly harmonized across the eu. for example, in order to further integrate these special medicines in the european regulatory framework, a committee for herbal medicinal products (hmpc) was established at the ema in september 2004 (replacing the cpmp working party on herbal medicinal products). the major tasks of this scientific committee are to establish community monographs for traditional herbal medicines, and to prepare and maintain a list of herbal substances that have been in medicinal use for a sufficient period of time, and so are not considered to be harmful under normal conditions of use [135] . the procedures for clinical trials in europe used to vary from one country to another. there were different national approaches regarding the approval and notification systems, documentation requirements, and timelines [136] . in october 2004, in order to coordinate the implementation of the new harmonized requirements across the member states, the hma established the clinical trials facilitation group (ctfg). the ctfg (attended by representatives from the national dras, ec, and the ema) acts as a forum for discussion on the agreement of common principles and processes to be applied throughout europe. it also promotes harmonization of clinical trial assessment decisions and administrative processes across the national dras. this group established a voluntary harmonization procedure (vhp) for the assessment of multinational ctas [138] . during this three-phase procedure, dras from all member states involved assess the application, though each member state remains ultimately responsible for the approval of the cta in its own country. however, there is a coordinated validation phase (phase 1) and voluntary cooperation of the member state during the assessment phase (phase 2) before the usual formal national process (phase 3). phases 1 and 2 of the procedure are coordinated by a vhp coordinator. the "acceptability statement" obtained through this vhp procedure is then included in the subsequent national cta applications. from march 2009 to april 2010, 30 applications were evaluated through the pilot vhp procedure; 23 of these applications received a positive opinion [139] . the average procedural time was 52 days (which is significantly less than the average time of standard national procedures). the overall feedback from sponsors was positive, except that: directive 2001/20/ec and its associated texts and guidelines are a very important step in the harmonization of procedure for the registration and conduct of clinical trials in europe. implementation of this clinical trials directive into national legislation of all 27 eu member states was completed in 2006. principles like clinical trial authorization by the national dras within defined maximum timelines led to significant harmonization of the clinical trial approval process. however, it has been agreed that this new system needs further harmonization in order to achieve the ultimate objective [142] . indeed, the actual assessment of a request for authorization of a clinical trial is done independently by the member states concerned. the legislation does not provide for a mechanism whereby the member states are obliged to reach a common conclusion regarding a clinical trial involving different member states. this lack of obligation and detailed direction implied different interpretation from member states and therefore created implementation issues. as a consequence, sponsors have to respond to the various required changes and adapt their protocol in view of diverging assessments by the dras. this situation requires additional time and effort by the pharmaceutical industry (without added value for the patients). in 2010, following a public consultation and a long and thorough impact assessment ( the proposal has been submitted to the european parliament and the council who engage in ordinary legislative procedure. this proposal, once adopted by the eu-legislator, is going to replace the 2001 clinical trials directive. it is expected to come into effect in 2016 and to provide major revisions to the current system (e.g., single assessment outcome, simplified reporting procedures, etc.). finally, it must be noted that other important topics related to the regulation of medicines are also coordinated at the community level (by the ec and the ema) in order to have harmonized regulatory actions and enforcements, and to complete the single pharmaceutical market. these harmonization initiatives are at different stages of development: • to support cooperation and harmonization activities, the eu needed systems and knowledge management support. the implementation of this telematics (the integrated use of telecommunications and informatics) strategy, coordinated by the ema, is critical to increase efficiency and transparency across the european medicines regulatory network. in addition to the standards for electronic submissions (esubmissions) that were developed and published, a central set of pan european systems and databases was created. these systems and databases exchange information with systems of external stakeholders and dras, while staying separate from them. they also help provide high-quality information on medicinal products to the general public and support the monitoring of the post-authorization risk and benefit balance of medicines in the eu. the following critical projects and tools have been developed under this program (some of them are still under development): ▸ eudract: the community's electronic database for clinical trials containing information submitted by sponsors. it informs dras of ongoing clinical trials in all member states and eea countries, enabling an overview of multi-state trials. the system also alerts dras in the case of early interruption or termination. ▸ eudragmp: community database on manufacturing and import authorizations and gmp certificates. the ema launched the first release in april 2007. this system is used by eu gmp inspectors to share information (i.e., gmp authorization, noncompliance with gmp information resulting from inspection activity, planned inspection activity, and "rapid alerts" arising out of faulty manufacture). ▸ eudranet: private electronic network linking the members of the european medicines regulatory network and ema. it ensures that both electronic mail between members of the network and their access to the eu telematics systems is secure. ▸ eudralink: the european medicines regulatory network's secure file transfer system used for exchanging information for regulatory purposes. it operates independently of eudranet, so that it can be used by applicants and marketing authorization holders, as well as the regulatory organizations within the network to transfer files. ▸ eudrapharm: the community's database of authorized medicinal products. some functionalities of this database are still under development. ▸ eudravigilance: system monitoring the post-authorization safety of medicines through safety reports (i.e., suspected adverse reaction reports). it is designed to receive, process, store, and make available information. one of the objectives of this system is the early detection of possible safety signals to facilitate the regulatory decision-making process (based on a broader knowledge of the adverse reaction profile of medicines). the ema to receive, validate, store, and make available information for review marketing authorization applications. the system's key benefit is its ability to take advantage of the lifecycle management functionality built into the ectd by easily allowing the full extent of the current valid documentation as well as its submission history. ▸ eu telematics controlled terms (eutct): central repository and publication system for a controlled term list used in the european medicines regulatory network. the establishment of the eu has not been easy, but it has represented the desire to end conflicts in europe. since its creation, the eu has been successful in delivering peace between member states and has reunited a fractured continent via the promotion of cooperative projects (i.e., economic and social). this cooperative initiative went beyond the initial objectives of its founders. ever deeper integration has been pursued while embracing new members. the membership of the eu has grown from 6 to 28 nations, bringing the eu's population to half a billion people. it has created stable institutions, a single market, and a single currency. despite numerous challenges, ggg the eu has survived, and is today a major economic and commercial power. although improvements are still needed in certain areas, the eu represents a unique model of successful cooperation, harmonization, and integration between countries of different languages, cultures, history, and levels of development. in the pharmaceutical sector, much has been achieved towards the consolidation of the european system of evaluation and supervision of medicines. several challenges have already been overcome, but outstanding issues still need to be resolved to further support and improve public health in europe, free movement and access to medicines in the community, and the competitiveness of the union. taking into consideration its successes and challenges, this section provides a balanced evaluation of the current situation. it demonstrates that harmonization of pharmaceutical regulation in europe can be considered a real and quick success in general (considering the major changes it required), but acknowledges some specific areas where work is still needed. for all these reasons, the development of the eu and its european pharmaceutical "regulation/ system" is a great example that needs to be further evaluated and discussed. although this model of harmonization and integration may not be fully applicable to other cases, this experience can certainly help other regional or global harmonization initiatives. since the adoption of the first pharmaceutical directive in 1965, many topics have been harmonized. the past 50 years have seen a gradual convergence of pharmaceutical legislation in europe. today, a considerable package of harmonized legislation (in the form of the pharmaceutical "acquis communautaire") is in place to support two objectives: the protection of public health and the free movement of products. these provisions/texts applicable to medicinal products are included in eudralex. they include binding legislation (i.e., regulations and directives), but also numerous technical guidelines and recommendations to facilitate the implementation of these common principles. a well-structured european pharmaceutical system has also been established. in addition to the european institutions necessary to harmonize and create the european pharmaceutical legislation, technical european bodies have also been established. today, the evaluation and supervision of medicines in europe is shared between european and national bodies that form a complex but well-organized network of approximately 5,000 technical and regulatory experts. words like "networking," "work sharing," and "harmonization" became common and remain crucial for the future. the establishment of the ema as a key coordinator of this system was an important decision for the integration and harmonization of practices and standards to support and promote the single european pharmaceutical market. the primary aim of this centralized system was to create conditions in which a single scientific evaluation of the highest possible standard would lead to rapid access to an integrated market of innovative and good cost-effective treatments. this objective, in large measure, has been achieved. the ema, which is comprised of experts provided by national dras, has today established itself as a leading world agency for the evaluation of medicines. its contribution to the effectiveness and efficiency of the eu system, and therefore to the protection of public health and to the achievement of an operational internal market, is well recognized by all stakeholders. the effectiveness of the system has been maintained despite its growing complexity. indeed, the increase in the number of centralized applications hhh and other procedures, eu enlargement, and new regulations have led to an increased workload and an enlarged scope of responsibility for the ema over the past 10 years. these changes have led to the creation of new committees (comp, pdco, cat, hmpc, prac) that require the implementation of additional procedures and new tools. these structural changes and increased responsibilities should be monitored closely in the future to avoid risks of inconsistencies, overlapping, bureaucracy, and rigidity. also, it is critical to continue to monitor financial compensation of national dras and to regularly assess the involvement of each member state in the eu pharmaceutical system to ensure availability of appropriate resources and expertise [150, 151] . within this legal framework and european pharmaceutical system, community authorization procedures (centralized, mrp, or decentralized) have been in place since the mid-1990s. the centrally coordinated tasks include assessments led by rapporteurs and co-rapporteurs, inspections, and pharmacovigilance through the medicine's lifecycle. although the national dras have prime responsibility for the efficient operation of mrps and decentralized procedures, national marketing authorizations, and clinical trial authorizations for human medicines, the ema has an important role in supporting these noncentralized functions. for example, the ema maintains the eudravigilance database and the eudract database, and supports a range of scientific committees and the coordination group for mrps and decentralized procedures [152] . the criteria for the approval of medicines and other technical topics have been extensively harmonized within the eu. many technical and regulatory guidelines have been released in all areas (quality, nonclinical, and clinical). there has been a specific focus in recent years to improve the european pharmacovigilance system, to simplify the variation system, to harmonize the requirements for clinical trials, and to implement an advanced therapies regulation. the establishment of the european pharmacopoeia has also been very important to ensure standardization of specifications and quality of medicines in the eu. all these measures and actions described above have led to improved marketing authorization procedures, the harmonization of data protection in the eu, better access to medicines for children, orphan drug development, clinical trials, and a new regulatory framework for advanced therapies. lifecycle management of products has also been improved (i.e., the revised legislation on variations to reduce the administrative burden by streamlining the circumstances obliging industry to file applications). the next review of the european system will be noteworthy because it will evaluate if new measures (developed following the last review in 2000) improved the system and produced real dividends in terms of cost efficiencies through economy of scale (via the reduction of the administrative burden where this did not have public health implications). it is also worth mentioning that this european system is solid enough to stand the challenges of new therapeutics. the current structure, forum, and processes allow "proactive" harmonization. indeed, most of the harmonization initiatives are created to discuss existing disharmonies on specific topics. at the beginning, the european harmonization effort, related to pharmaceutical regulation, was focused on disharmonies between countries. today, even if disharmonies do still exist on some specific subjects, many topics have been successfully harmonized. the processes and structures that have formed over the years now allow the system to cover new subjects for which no national regulations and requirements have been developed yet. developing this new regulation at the eu level automatically creates harmonized requirements (this can be called "proactive harmonization"). . this group, which included ema staff and members of the chmp and its working parties, generated recommendations on how the ema should tackle these new emerging topics not covered by the existing national, regional, or global regulations and standards. ▸ ema innovation task force (itf): in order to provide support for medicine innovation in the eu, the ema established an internal horizontal cross-sectorial group to focus on emerging therapies and technologies. the itf brings together competences from the areas of quality, safety, efficacy, pharmacovigilance, scientific advice, orphan drugs, and good practices compliance, as well as legal and regulatory affairs. one of the objectives of the itf is to address the impact of emerging therapies and technologies on current scientific and regulatory requirements. its scope also encompasses areas for which there are no established scientific, legal, and regulatory experience. one of their tasks is to identify areas for legal, regulatory, and technical guidance preparation and proposals for consideration by the ema committees and working parties, and to contribute to relevant ec initiatives and legislation [154] . the eu today is recognized as a major player in the international harmonization of pharmaceutical regulations. it has developed privileged relationships and initiated cooperation projects with other countries outside the european community (major developed countries and emerging markets). for example, the ema cooperates with many of the world's largest regulatory bodies outside the eu iii in areas such as inspections, safety of medicines, and exchange of information on issues of mutual concern. the establishment of the international and european cooperation sector, formed in february 2012 and responsible for the development, coordination, and implementation of the agency's international strategy and activities (including confidentiality arrangements with countries outside the eu), demonstrates the ema commitment to international cooperation [155] . also, collaboration has been initiated with china, india, and russia on pharmaceuticals, and it is partnering with international organizations (i.e., ich, who, and pic/s). this work should continue and also be extended. it is indeed important to support the development of globally harmonized standards and requirements in order to ensure fair competition with other parts of the world for the development of medicines and to avoid delay in the availability of essential medicines for european patients. ensuring against falsified medicines, resolution of pandemic issues, product development in emerging markets, and reliability of clinical data produced outside europe are good examples where international cooperation is necessary to ensure adequate protection of public health in europe. in spite of all the above-mentioned major progress and regular improvement of legislation by the european commission, there is still room to improve the eu pharmaceutical system. on the regulatory side, issues dealing with the implementation and interpretation of community legislation by member states continue to create obstacles to the free movement of medicines. stakeholders continue to raise concerns regarding market fragmentation linked to disparities in national pricing and reimbursement schemes (despite the adoption of directive 89/105/eec in the early days of the european pharmaceutical system), unnecessary regulatory burdens caused by divergences in the implementation of community legislation (e.g., clinical trials requirements), and a lack of commercial interest in national markets that are economically less attractive. european patients still suffer from inequalities in the availability and affordability of medicines. this situation could worsen and create significant inequalities between patients in accessing medicines if it is not resolved. additionally, europe has been losing ground when it comes to innovation and competitiveness in the pharmaceutical market. in its communication of december 10, 2008 [156] , the ec recognized that further harmonization is necessary to resolve shortcomings in the eu pharmaceutical market in furthering increased globalization of this sector. to improve this issue, the ec confirmed its objective to continue to progress towards a single and sustainable pharmaceuticals market [157] . to further support and improve the public health in europe and free movement of medicines within the community, and to maintain its competitiveness, the eu needs further harmonization in several areas, such as: novel medicines by patients, mainly due to increased pressure to cut healthcare budgets. in certain countries, medicines are not made available due to administrative requirements and poor economic rewards. a lack of transparency and harmonization with regard to pricing, reimbursement, and relative effectiveness remains a challenge [158] . in contrast to the benefit-risk assessment carried out by regulators, national hta bodies compare the "relative effectiveness" of medicines and take their financial cost into account. this post-marketing national hta evaluation can lead to national differences due to different country needs. the addition of different requests (i.e., different type of studies) from regulators and hta bodies can also delay availability of new products. to resolve this major issue, the european network for health technology assessment (eunethta) was established to support effective collaboration between national htas. also, the ec gave the political mandate to the ema to begin interacting with hta bodies when it published the conclusions of the pharmaceutical forum in october 2008. kkk since then, the ema has begun to collaborate with national hta bodies and with eunethta [159] . this interaction focuses on centralized approved products and aims to facilitate communication between ema and hta bodies early in a medicine's development and throughout the medicine's lifecycle. as mentioned above, the harmonization of price and reimbursement evaluation is critical in supporting a european pharmaceutical market. however, it will be a very difficult and long process to implement due to political and budgetary aspects and differences in pharmaceutical markets and healthcare budgets existing between member states. the european clinical trials directive (directive 2001/20/ec) has been an important and necessary step in the harmonization of european pharmaceutical regulation. the principles defined in the declaration of helsinki (in 1964) and the ich gcp e6 guideline (in 1996) allowed some harmonization of clinical practices and protection of clinical patients. but, before this directive came into force, the rules for performing clinical trials (i.e., regulatory procedures and requirements) varied significantly in the european community as they were based on differing regulatory approaches in the member states. this new legislation promoted harmonization of clinical trial practices allowing important improvements related to the protection of patients (i.e., safety and ethical concerns) and reliability of data, and facilitated the exchange of information between dras. however, despite this progress, important negative effects of this new legislation have been reported (e.g., the increase in bureaucracy and administrative costs). the number of clinical trials carried out in the eu has fallen by 15% in recent years, while administrative kkk the pharmaceutical forum was set up in 2005 by the european commission as a three-year process in order to find relevant solutions to public health considerations regarding pharmaceuticals, while ensuring the competitiveness of the industry and the sustainability of national health care systems. more specifically, this forum analyzed three key themes: information to patients on pharmaceuticals, pricing and reimbursement policy, and relative effectiveness. costs and delays have doubled [160] . it is still labor intensive and costly to duplicate largely identical administrative procedures for multinational clinical trials. additionally, sponsors spend a great deal of time retrieving the relevant national information and requirements and preparing customized applications without added value for the patient and the regulators (the core scientific information is the same, but the format and administrative information and forms differ). it is indeed a problem for a large pharmaceutical company, as it usually requires additional dedicated departments with the necessary resources to track differences in national requirements and follow the many parallel procedures. but it is even more problematic for smes or academic sponsors for whom these costs can reach prohibitive levels. this multiplication of parallel procedures also has an important impact on the dras. indeed, available resources are used in multiple assessments of the same core information in different member states, which clearly delays the start of clinical studies. it is important to note that this duplication of assessments does not necessarily increase the quality of the assessment, as the necessary specific expertise might not always be readily available in all the member states concerned. this is a nonefficient use of national resources without added value for the patients or science. this implementation problem is partly due to the legal framework that has been chosen for harmonization in this area. as with all directives, the clinical trials directive had to be transposed in national laws. unfortunately, in this case, the objectives of the directive were transposed into divergent national legislations, somewhat missing the harmonization goal and making multinational trials difficult to perform. in its 2009 consultation paper [161], the ec proposed options to improve the situation. one of the best options is to continue with the harmonization process. this would mean creating a real european system of authorization for clinical trials to avoid duplication of assessment. it would avoid the inconsistent assessment conclusions and requests, encourage appropriate use of resources and expertise (for both the sponsors and dras), and ensure common implementation of the principles laid down in the clinical trials directive. the vhp initiative seems to be a good first step. it allows for a better implementation of the eu clinical trials directive principles and further harmonizes the conduct of clinical trials in europe. however, this procedure cannot be considered as the ultimate solution because it does not resolve all issues [162] . more specifically: • there are still parallel cta assessments by multiple dras. • there are still major differences between countries regarding the time it takes to issue approval. • this is a voluntary cooperation and there are differences in the level of interest and responsiveness between countries. • the current procedure does not remove specific national requirements or differences between national assessments (this is a cooperation effort, not a harmonization of requirements). • this process does not accelerate the first patient enrolled (fpe) in europe. to resolve these outstanding issues, the current vhp procedure should be revised to become a real mrp where the assessment will be conducted by only one reference member state. the content of the dossier should also be fully harmonized between countries. the establishment of a centralized procedure through a new regulation (which will deliver a pan-eu approval) would also be very helpful for certain types of products that require specific expertise not available in all eu countries (e.g., advanced therapies), for orphan drugs, and/or for pediatric medicines. this centralized process for cta would be a good bridge between the ema scientific advice process and the centralized registration procedure. the system for registration of clinical trials would then mimic the system already in place for the registration of medicinal products with a combination of three types of procedures: • centralized procedure for specific products such as biotechnology and advanced therapies • mutual recognition procedure for other multinational clinical trials • national procedure for a clinical trial involving only one member state this reorganization of the system and procedures, supported by the ec [163] and most of the shareholders involved in clinical trials [164] , would utilize the current structures and expertise in europe, would build on the experience acquired with the registration process, and would facilitate patient access to clinical trials and to new technology within the community. it would allow the necessary flexibility and different levels of review for interventional trials (e.g., a small national study with a well-known entity does not need the same type of evaluation, organization, and bureaucracy as a phase 1 study with a new fusion protein or a large multinational phase 3 study). measures should be put in place to ensure that such reorganization would allow this flexibility and avoid any further increase of delay and administrative costs and burdens. for example, "recognition" of other assessments should be the focus, and "nonrecognition" should be limited to major issues (that should be clearly defined). these "nonrecognitions" of assessment by another country should be rare to avoid regular arbitration or appeals that would further delay the start of the clinical studies. selection of reference member states (rms) should also be defined because many parameters are involved in such selection (i.e., expertise, resources, balanced workload between countries, etc.). finally, this new cooperative system should not result in the simple addition of national requirements, but a harmonized scientific assessment that would be implemented equally in all member states. this next step in the harmonization of a clinical trial in europe would certainly be beneficial for patients, sponsors of clinical trials (pharmaceutical companies, but also small entities or academic centers), and dras. some of the above proposals have already been recommended by the european commission [165] . the recent adoption of a "proposal for a regulation of the european parliament and of the council on clinical trials on medicinal products for human use, and repealing directive 2001/20/ec" [166] by the commission represents an important step in the improvement of the current system. however, this process will take time to implement, and national interests will need to be overcome. finally, the assessments of ethics committees also need to be reviewed and improved. the clinical trials directive is based on the concept of one ethics committee opinion per member state concerned. however, several member states maintain a decentralized system where the single ethics committee opinion is based on the opinion of several local committees. as a consequence, in the eu there are approximately 1,900 ethics committees involved in the assessment of clinical trials [167] . also, better harmonization of responsibilities between dras and ethics committees must happen across europe [168] . it is agreed that ethical issues fall within the responsibility of member states. however, current practices need to be reviewed in order to smoothly integrate an improved harmonized system and to protect european clinical trials subjects. these programs are important to make new therapies available to patients as soon as possible. they should be handled on a european basis in order to ensure that every european person, wherever their location, has the equal right to access these new medicines at the same time. today, this difference in access within europe is clearly contrary to the overall european objective to ensure that all patients within the community have the same access to the same quality products throughout europe. of course, the harmonization of these requirements and procedures should be carefully implemented to avoid the creation of delays compared to the current situation. ▸ pharmacovigilance: the eu pharmacovigilance system demonstrates that cooperation and harmonization of regulations and practices in europe is beneficial to patients. indeed, merging the eu national pharmacovigilance systems into one network increases the quantity of data/reports/ information, which facilitates the early detection of possible safety signals, and therefore the monitoring of product safety. unfortunately, the mediator issue in france has shown that the eu pharmacovigilance system needs to be improved to be fully functional. this topic has been one priority of the european network. the ongoing implementation of the new legislation by the ema and the member states will be critical. although the mutual recognition and decentralized procedures have improved over time, challenges still exist, and the principle of these procedures (i.e., recognition of another country's assessment) is not always respected. in both these procedures, member states can only refuse to recognize other countries' assessments if they feel that this recognition could have a "potential serious risk to public health." unfortunately, this reason for disagreement is vague enough to allow flexibility for member states. in 2006, a guideline was released [171] to further clarify how this risk should be defined. however, some national dras continue to have a broad interpretation of "potential serious risk to public health," and trigger ema arbitrations for grounds that do not fall under this specific category [172, 173] . in addition to the specific issues discussed above, more general challenges can also impact the harmonization of european pharmaceutical regulation. although these general considerations are not specific to the pharmaceutical sector, they can influence the establishment and implementation of pharmaceutical regulation. therefore, they need to be understood and integrated when developing implementation plans and timelines: • . this major difference in workload between countries demonstrates a big gap in work sharing and certainly highlights differences in national dras' expertise and resources and pharmaceutical companies' interests for each national market. • one of the complexities and difficulties of the eu system is the division of activities undertaken at the national level (e.g., clinical trial responsibility, scientific advice handling, etc.) and at the eu level (e.g., equal scientific advice handling, assessment of pediatric investigational plans, etc.). this requires many communications and infrastructures between the eu and national players. • external economic or political factors could also influence the harmonization of european pharmaceutical regulation. for example, the modification of european borders via new enlargement of the eu (even if the eu leaders have agreed to mark a pause for now, discussion on the accession of countries such as turkey, iceland, and serbia are still ongoing). additionally, the possible creation of a "mediterranean union" desired by past french president sarkozy could also impact the scope and timelines of the next steps of harmonization and integration. finally, it will be important to see if and how the two new functions created by the treaty of lisbon (president of the eu council and high representative of the union for foreign affairs and security policy) will benefit the eu. the first important dossiers after the creation of these two functions (global financial crisis, global security, and support to greece) have indeed still been handled by the political leaders of major member states (i.e., france and germany). it is clear that the european system is integrally linked to its own history. this model cannot fully fit every harmonization initiative in the world because every situation and need is different. however, it is worth reviewing the lessons learned from this 50 plus years old initiative. this first regional harmonization initiative (rhi) overcame a lot of challenges, and has since developed into a strong regional harmonized pharmaceutical regulation and system. this success demonstrates that an organized cooperation and harmonization can facilitate the development of high standards and practices. more specifically, the european initiative clearly demonstrates that a structured stepwise approach is necessary: ▸ first, it is necessary to set up major principles (directive 65/65/eec). ▸ second, it is critical to provide specific detailed requirements and to further detail the agreed principles (directives 75/318/eec, 75/319/eec, etc.). ▸ third, a structured and organized system is needed to implement the principles and requirements. technical bodies need to be established to control medicines and manage the establishment of common procedures (especially centralized types). in europe, it was key that the national dras provide expertise and resources to european bodies not only to ensure appropriate availability of resources, but also to ensure full adhesion of the countries into the system and adequate communication between all players of the system (national and european). ▸ when all the basic principles and a system are in place, additional more specific requirements can be discussed so that the system can take into account particular needs (i.e., specific requirements for specific products, population, etc.) in order to have a more coherent system. ▸ finally, it very important to monitor the system and regularly review the extent to which this system and measures support the harmonization goals and meet the predefined objectives. evolution of the environmental impact (i.e., globalization, change of membership, change of political commitment, and need for new requirements due to emerging problems, etc.) also has to be taken into consideration, and the regulation and system needs to be carefully adjusted to ensure its longevity. another lesson learned from europe is the importance of cooperation. to be successful and ensure effective functioning of this system, cooperation between the different entities of the system (ema, hma, national dras, ec) has been, and remains, critical. even if the european pharmaceutical system is complex, it is well organized. the provision by the member states of high-quality scientific resources for the evaluation and supervision of medicines is a critical factor for the success of the eu system. indeed, scientific excellence (as a result of eu-wide pooling of expertise and data) has been a key strength. in this respect, it should be stressed once again that such excellent progress has been highly dependent on close collaboration between the ema and the national dras within the context of the eu regulatory network, and in particular on the valuable input of high-quality specialist expertise provided by the member states. this provision of national resources, coordinated by the ema, is one of the features of the eu regulatory network. this success also relies on political support for this european harmonization initiative in order to support the creation of the single market. without this political commitment (and therefore associated funds and resources), it would have certainly been much more difficult and taken more time to create this system. it is recognized that other harmonization initiatives in the world are certainly suffering from the lack of such political commitment, especially when such harmonization is not driven by the willingness to create a single market (i.e., integration model). finally, the eu has also clearly demonstrated that better organization at the regional level is extremely critical to ensuring the success of global harmonization and cooperation. even if all regions are not working towards integration like europe, this example of better coordination and representation should be followed and discussed in other regions of the world. indeed, this example demonstrates that a well-organized and coordinated regional structure is beneficial to all stakeholders [176]: ▸ individual countries via better representation and better access to international activities/agreements/decisions through regional structure (this is especially true for small countries with less expertise and resources). individual countries also benefit from the infrastructure (i.e., databases or training programs) and good practices developed at the regional level. ▸ regions because they allow better representation of interests (europe has more power than a combination of small countries' voices, and has an impressive network of experts). ▸ international cooperation and harmonization initiatives because they facilitate communication by reducing the number of contacts and seats at the international level (but provide a structure for dissemination of information). for example, having all eu countries represented at ich would not be possible. this regional coordination is very important for the future of global initiatives (such as ich or who projects), but it is even more important in the management of a worldwide health crisis (e.g., pandemic influenza). this european coordination system should be implemented in other regions of the world because the coordination of rapid and efficient communication of information and actions during such a crisis helps the overall coordination of the situation. for example, in the recent case of pandemic influenza, it was critical to have central coordination (not only global, but regional). the ema (using its "crisis management plan") allowed europe to respond rapidly and efficiently to the challenges of an outbreak of pandemic influenza by: ▸ the fast-track review of vaccines (using its best experts) ▸ monitoring the safety of centrally authorized pandemic-influenza vaccines and antiviral medicines ▸ liaising and coordinating activities with critical partners, including the ec, eu member states, other european agencies (such as the european centre for disease prevention and control), and international partners (such as who and regulatory bodies of non-eu countries) to ensure timely exchange of information and coordination of activities relating to the pandemic ▸ coordinating the communication of relevant information to the public, healthcare professionals, and the media all of these activities would be less efficient if performed by each individual country. political and economic development in the pan-american region has resulted in interest in regional economic integration. several subregional integration groups have emerged in this area since the 1970s. harmonization of pharmaceutical regulations and technical standards is a component of this economic integration, but the degree of progress in this area varies a lot from one subregion to another (and even from one country to another). in light of these various economic integration initiatives, the need became evident for an entity in which the different countries of the region could share experiences and expertise. the pan-american network for drug regulatory harmonization (pandrh) was created in november 1999. this is a regional initiative established to promote drug regulatory harmonization throughout the pan-american region within the framework of national and subregional health policies. this continental forum is not a supranational entity, and its decisions represent recommendations to be assimilated into the subregional integration initiatives. the mission of this network is "to promote the harmonization of pharmaceutical regulation covering aspects of quality, safety, efficacy and rational use of pharmaceutical products, the strengthening of national regulatory authorities (nra) capacity within the region of the americas based on the right of the population to access quality medicines, recognizing advances in science and technology and within the context of national and sub-regional realities" [177] . the objective of this initiative is to facilitate regional harmonization of medicinal drug requirements and guidelines for specific regulatory issues. this objective is achieved by adopting recommendations for implementation at national and regional levels, and also by supporting the development of training on specific important topics. however, this initiative also has broader objectives such as: ▸ promoting and maintaining a constructive dialogue among dras, the pharmaceutical industry, and other sectors ▸ strengthening the dras of the region ▸ encouraging convergence of drug regulatory systems in the pan-american region ▸ facilitating technical cooperation among countries in collaboration with subregional integration groups. since 2003, pandrh has been a member of the ich global cooperation group (gcg). this membership broadens pandrh's role because this regional harmonization initiative is now also involved in global harmonization. pandrh provides a way to disseminate recommendations on drug regulatory harmonization of global initiatives. it also ensures that regional specificities and challenges will be considered when new global recommendations are discussed. ▸ dras of all pan american health organization (paho) member states ▸ regional pharmaceutical industry associations: latin american association of pharmaceutical industry (alifar) and latin american federation of the pharmaceutical industry (fifarma). ▸ academia ▸ consumer groups and professional associations it also includes representatives from the five subregional trade integration groups within the americas (plate 2) that are themselves multinational cooperation initiatives but are working on a broader integration with emphasis on political and/or financial interest: ▸ the andean community is a community established in 1969 (by the cartagena agreement) that currently regroups four countries (bolivia, colombia, ecuador, and peru). chile and venezuela have also been part of this initiative in the past and some others countries are observers. these countries decided voluntarily to join together for the purpose of achieving more rapid, better-balanced, and more autonomous development through andean, south american, and latin american integration. they also created a free trade area (including the four current members plus venezuela). this integration initiative is broad and regroups several areas, one of them being health. the integration of health is governed by the andean health body, which coordinates the actions aimed at improving the healthcare of member countries. it gives priority to cooperative mechanisms that promote the development of subregional supranational systems and methodologies. these actions are also coordinated with the other subregional, regional, and international organizations. discussions include many topics such as the development of a pharmaceutical policy model, the evaluation of medicinal products, and a surveillance network. ▸ sica (the central american integration system) is the institutional framework of subregional integration in central america. this is the latest step of a long integration process in the region. it was created in december 1991 (by the signing of the tegucigalpa protocol) by the states of belize, costa rica, el salvador, guatemala, honduras, nicaragua, and panama. this initiative also involves the dominican republic as an associated state and some regional and extra-regional observers (mexico, chile, brazil, china, spain, and germany). the headquarters of the general secretariat is located in el salvador. the first objective of this integration process in central america was to transform the area into a region of peace, liberty, democracy, and development, based firmly on the respect, tutelage, and promotion of human rights (following a history of political crisis, conflict, and dictatorial rule in the region). health topics are covered by the executive secretariat of the council of ministers of health in central america (se-comisca). several projects are under discussion in this subregion, such as the basis for quality assurance of drugs and a pharmacovigilance system. ▸ mercosur (the "common market of the south") was created in 1991 (by the signature of the treaty of asuncion) and encompasses five latin american countries (argentina, brazil, paraguay [which is currently suspended], uruguay, and venezuela). the purpose of this agreement was to set up a common market and eliminate trade barriers among the signatory parties. mercosur has been involved in several health projects (such as implementation of gmps with training and joint inspections and development of programs on vaccine regulation and control) to promote cooperation between its members and harmonization of specific pharmaceutical regulations in this subregion. to date, there is no mutual recognition system. ▸ nafta (north american free trade agreement) was implemented in january 1994 to remove most barriers to trade and investment among the us, canada, and mexico. the objective of this agreement was to establish procedures to facilitate trade and investment on the north american continent. this trade liberalization had some positive impact and created one of the largest trade blocs in the world, but some downsides have also been reported by economists (who have shown that nafta has not been able to produce an economic convergence). nafta has had a minor impact on the harmonization of pharmaceutical regulations in the region and has not been able to resolve the problem of parallel import of pharmaceutical products between canada and the us. one of the major components of this initiative is the pan-american conferences on drug regulatory harmonization held every two to three years. these conferences are the highest instance of the pandrh network. they serve to define priority areas for harmonization and to endorse standards, guidelines, and other recommendations, including norms and procedures and steering committee membership. they also provide a forum for discussing issues of common interest in drug regulation. participants include all interested parties such as the dras of all paho member states, representatives of the regional pharmaceutical industry associations, academia, consumer groups, professional associations, and representatives from the five subregional trade integration groups within the americas. the 1st pandrh conference took place in november 1997 (in washington, dc, us). pan-drh was then officially created during the 2nd pandrh conference in november 1999 (also in washington, dc). following these first two conferences, subsequent conferences took place to review ongoing activities of the working groups. pandrh mimics the ich structure. it is organized around three major bodies: ▸ the steering committee (sc), which ensures operational management of this initiative between conferences, is composed of: • seven members from five national dras (one from each of the subregional economic groups) and two industry representatives (fifarma and alifar) • seven alternate members from five different national dras (one from each of the subregional economic groups) and two industry representatives (fifarma and lifar) • regulators from other countries (not represented on the sc), representatives from nongovernmental organizations (ngos) recognized by paho/who, and other stakeholders invited by the sc who may also participate in sc meetings as observers members of the committee serve for a period of four years, with staggered rotation to maintain continuity. the sc meets at least twice every year. its primary role is (1) to establish the agenda for the biennial pan-american conferences, and (2) to follow up on conference recommendations by establishing and monitoring the progress of working groups. the responsibility of this group is to promote progress between conferences through the coordination, promotion, facilitation, and monitoring of the harmonization activities. ▸ the technical working groups are specifically formed to work on topics and areas identified for harmonization. the members are experts in their specific subject matter. a working group may include the following categories of members: • main members that represent the national dra of a country in each of the five subregional blocs, the regional industry associations alifar and fifarma, and those designated by the secretariat • alternate members designated to attend the meetings instead of the principal members • observers from any country generally nominated by a participating national dra (the observers do not retain voting rights) • expert resources (as needed) to support a specific activity of the group (expert resources do not have voting rights) the national dras of countries not represented in the working group can designate focal points to follow the activity of the group. each working group has a coordinator (and an alternate) who chairs and coordinates the meetings, leads the development of documents, and reports periodically to the sc on the progress of the group. in general, the first task of a new working group is to conduct a survey to identify the differences in regulatory requirements among countries in order to prepare a work plan. then, the group reviews international and regional and/or national recommendations and guidelines and prepares a harmonized proposal. when the harmonized standard is developed, the working group is in charge of designing training and helping in implementation of this standard by assisting countries in the dissemination and education concerning this new rule. technical working groups meet in conjunction with sc meetings or separately (determined by a work plan and resources). ▸ a secretariat, provided by paho, supports the initiative technically and administratively. it monitors the pandrh website, serves as a focal point for the coordination and dissemination of information, coordinates activities arising from recommendations of the conferences and sc, and acts as liaison and a representative of the network in global and interregional harmonization organizations (icdras, ich, etc.) as in other regions of the world, there is a need to promote harmonization of pharmaceutical regulations to facilitate the availability of safe, effective, and good-quality products and thereby protect public health. paho initiated communication among the different members of the pharmaceutical sector in the americas in order to facilitate communication among the different subregional blocs (and also the countries not already covered by these blocs) and organize regional harmonization. the first pan-american conference took place in november 1997 (in washington, dc, us). this conference was considered the first step towards the establishment of pandrh. during this first conference, the scope and the term "harmonization" were defined (as the search for common ground within the framework of recognized standards, taking into account the existence of different political, health, and legislative realities among the countries of the region). the structure and financial support of pandrh were also discussed at this first conference. however, pandrh was officially created during the 2nd conference (november 1999 in washington, dc) following a consultation in caracas, venezuela in january 1999, and also several ad hoc discussions and meetings (meeting of americas' regulators in washington, dc in november 1997, regional working group on bioequivalence in caracas in january 1999, and regional working group on gcp in buenos aires in may 1999). during this second conference, the mission statement and objectives of the sc were agreed upon. this initiative was then officially recognized by the 42nd directing council of the paho in september 2000. resolution cd42.r11, which was approved during this council, provided strong support from ministers of health of the member states in the region to pandrh and to the process of drug regulatory harmonization. during pandrh conference v (in buenos aires in november 2008), the regulations governing pandrh (mission, structures, and procedures) that were originally created during the 2nd conference were slightly modified to incorporate lessons learned during its first few years of establishment [178]. harmonization proposals are developed by the technical working groups. these groups primarily use who documents as the basis for developing regional guidelines. other international guidelines including ich and selected regional (e.g., eu, american subregional) or national technical documents are also used as the basis for harmonization proposals and as reference materials. after a working group has agreed on a draft harmonized document, it is posted on the website for external comment. comments are reviewed by the working group to prepare the final version of the document that will be presented for adoption by the conferences through the sc. conclusions and recommendations of the conferences are to be adopted by consensus (if consensus cannot be reached, the different points of view have to be recorded). during its seventh meeting (in june 2006 in washington, dc, us), the sc established a system of phases and stages for its harmonization process. this system, which mimics the ich process, is composed of five phases, with each having substages: final technical documents are intended for use at the national level (through the subregional integration groups), but this implementation is at the discretion of each country. members of the sc are responsible for monitoring implementation in their subregion. pandrh is also discussing strategies to follow up the implementation of its recommendations at the national and subregional levels. in addition to the biennial pan american conferences on drug regulatory harmonization that allow for communication and exchange, pandrh is also committed to training all interested parties (including regulators and industry). such training covers major topics such as gmp inspection, gcp, glp, bioequivalence, etc. the initial priorities that the pandrh defined during the first conference were gmp (to facilitate the implementation of gmp in the region and ultimately to develop mechanisms for mutual recognition of inspection), bioequivalence, and gcp. additional topics were then added, each of these considered critical in the development of the network and in the protection of public health in all concerned countries. currently, there are 13 areas of priority that have been selected by pandrh (for which working groups have been established): several recommendations developed so far are based on who recommendations. for example, who report 32 was the basis for the discussion on gmps, and the who and ich guidelines were used to build consensus on gcps. most of the selected topics are technical and have been chosen in order to ensure the quality, safety, and efficacy of the products approved, and that these products are adequately promoted and maintained. the work on drug classification is also key to ensuring a common language and facilitating subsequent harmonization discussions. combat against drug counterfeiting has also been selected, as this is a major issue in this region directly affecting public health in all countries and requiring a multidisciplinary, multi-sectorial, and crossborder perspective. finally, the activity on drug registration is a broader project, and is very important for ensuring implementation of pandrh recommendations and for reaching full harmonization of pharmaceutical regulations. this is critical in ultimately developing a collaborative regional or subregional registration process and system and sharing of expertise and resources between countries. this group drafted a proposed list of harmonized requirements for drug registration in the americas [179] . the current list of selected topics above will certainly be amended in the future if new emerging topics (creating potential health public issues in several countries of the region) need to be discussed and resolved at a regional level. for example, the working group on biotechnological products has been established following a roundtable session of the 5th pandrh conference. this roundtable session was organized to discuss biotechnological products (and also the specific issue of biosimilars). biosimilars present a clear risk for the patient (if they are not well controlled), but also a major opportunity for increased access to cheaper essential medicines (if they are well regulated). these biotechnological/biologic products have unique technical challenges that require technical and specific expertise. pandrh will have to work on this topic collaboratively with who, which has already released recommendations on this topic. pandrh's scope of harmonization and cooperation includes technical guidelines, regulatory processes, and the strengthening of national dras through harmonization of processes and standards to improve and assure drug quality. by adopting its recommendations and standards, countries in this region can clearly improve the quality of their regulatory system and provide access to quality, safe, and effective drugs. moreover, pandrh plays an important role in the global harmonization of pharmaceutical regulations. it is an important link between global organizations/forums and the regions. through its involvement in the ich gcg, it increases: ▸ the integration of the regional challenges/priorities/vision in the development of international standards ▸ the implementation of such international standards in the region this regional initiative is one of the most difficult to operate because it includes very different regulatory systems and structures (from the most developed system such as the us fda to the most undeveloped countries in the world). this initiative also has to take into account the existence of very different political, health, and legislative realities among the countries that correspond to very different priorities, interests, and resources. this reality creates difficulties in the management of projects and the establishment of consensus [180] . however, this disadvantage also provides opportunities and benefits as the most developed dras can help to mentor the less developed ones. recognizing preexisting asymmetries in the region, pandrh has become a forum to discuss common issues on drug regulation and share knowledge and expertise. not all the countries are involved in actually developing the proposals, but all of them participate in the decision of adopting them via the conferences. by promoting the collaboration of experts from different countries/subregions, and also from both the public sector (authorities and academia) and private sector (industry), pandrh has developed quality recommendations (frequently based on who or other international reports and recommendations). it must be noted that pandrh is clearly dependent on paho/who. without this support and investment, pandrh would certainly not be viable. indeed, this financial, technical, and administrative support from paho/who, which represents an important recognition (both in and outside the region), is critical for the following reasons: ▸ as for all such multinational initiatives, one of the challenges of pandrh is funding. pandrh's budget is primarily supported by paho, but additional funds also come from governments, the pharmaceutical industry, international organizations, and registration fees from training courses. ▸ resources from involved countries are limited. paho, by providing a secretariat, has structured this initiative and allows the practical development of the harmonization projects. ▸ who provides critical technical help for the preparation of pandrh recommendations. most pandrh guidelines and documents are indeed based on who reports. the 6th conference of pandrh, held in july 2011 (which included over 300 participants from 26 countries), focused its discussions on the theme "strengthening national health regulatory authorities." several working groups presented the conclusions of their work and their recommendations and actions. the topics also addressed during this conference included the role of pandrh as coordinator of international cooperation, paho's recognition of national regulatory reference authorities (anmat-argentina, anvisa-brazil, invima-colombia, and cecmed-cuba), implementation of the pandrh guidelines in the subregions, and innovative activities of the national dras in surveillance or in treatment compliance. this conference concluded with the approval of a strategic orientations document. the main recommendations were aimed at developing more effective cooperation among countries to guarantee, inter alia, the adoption and implementation of the different technical documents produced. the major challenges for the future (what pandrh will be assessed on) is the implementation of both its own and ich's recommendations. this will determine if this initiative delivers on its promises and if the countries that form this initiative are committed to this harmonization. because dras of all countries in the region participate in the conferences, it is expected that recommendations and guidelines will be adopted and implemented by the individual countries and incorporated in the discussion at subregional economic groups. however, it may not always be so straightforward/automatic, and the implementation of its recommendations may become one of the major challenges of this regional initiative because its members have no obligation to implement harmonized standards. the decision to develop a 2013-2020 pandrh strategic plan to guide future development of the network, and ensure flexibility, scientific rigor, and representation of all stakeholders in the network [181], will certainly strengthen this initiative. the gulf cooperation council (gcc), also known as the cooperation council for the arab states of the gulf (ccasg) is a political and economic union. established in 1981, this trade bloc comprises six arab states of the arab gulf. it represents one of the wealthiest country groupings in the world due to its extensive oil and gas reserves. its population is approximately 42 million and its gross domestic product (gdp) is estimated at approximately us $917 billion [182] . the gcc has been active in political affairs outside its territory. due to the instability of the middle east region, the gcc has been heavily involved in diplomatic discussions to solve the different conflicts and problems of the region (i.e., iraq/iran war, iraqi invasion of kuwait, iraqi situation after the breakdown of the former regime, israeli/palestinian war, etc.). the objectives are to avoid the expansion of war and eliminate violence and terrorism in the region in order to support regional development and modernization. in order to achieve unity, the gcc promotes the coordination, integration, and interconnection between its member states in various fields. one of the first objectives of the gcc is to formulate similar regulations in different areas, including health. cooperation and coordination in health are under the responsibility of the council of the gcc health ministers (chm). under its oversight, the gulf central committee for drug registration (gcc-dr) was established to provide gulf states with safe and effective medicines at a reasonable cost. this committee works towards this objective by promoting cooperation and harmonization among member states. this initiative covers prescription, nonprescription, generics, and biologics. on the international side, the gcc represents the region at the ich global cooperation group (gcg). the current gcc members are six arab states of the arab gulf (plate 3): bahrain, kuwait, oman, qatar, saudi arabia, and the united arab emirates (uae). iran and iraq are currently excluded although both nations have a coastline on the persian gulf. yemen is currently not part of the union. this country is, however, involved in some gcc initiatives (i.e., activities related to the health sector) in view of a future accession. for example, yemen is a member of the council of the gcc health ministers (chm). the supreme council is the highest authority of the gcc and is formed by the heads of the member states. presidency of the gcc supreme council rotates, and it convenes annually in a regular session, though additional extraordinary sessions may also be scheduled. this supreme council is supported by the ministerial council, composed of the ministers of foreign affairs of member states or other ministers acting on their behalf. the ministerial council proposes policies, lays out recommendations, and coordinates existing activities in all fields. resolutions adopted by other ministerial committees are referred to the ministerial council, which in turn refers relevant matters to the supreme council for approval. the chm is the highest regional level of authority in the area of health. it consists of health ministers from each of the gcc member states (plus yemen, though presently not a member). it meets for two to three days twice a year, and these meetings are open to all regulators from the gcc member states and yemen. who (via its regional office for the eastern mediterranean, emro) also attends as an observer. the chm is supported by an executive board to whom an executive office general director reports. the executive office is located in riyadh, saudi arabia. at the working level, a gcc-dr was established to oversee the different activities in the pharmaceutical sector. the steering committee of the gcc-dr is composed of two members from each of the member states (including yemen), and meets at least four times per year. the membership is limited to government agencies or dras. the executive office also appoints two of its affiliates as advisors (nonvoting members) to the steering committee. this committee is responsible for the registration of the pharmaceutical companies and their products as well as for the preparation of technical regulations and guidelines. to develop a new guideline, the gcc-dr steering committee uses the resources of the member states by assigning the drafting of the specific guideline to either a single member state or several member states. technical working groups can also be set up to help in developing the guideline. within the executive office, a permanent gcc-dr secretariat was also created to support the organization. the role of this secretariat is to facilitate the harmonization activities through administration, coordination, and communication. it is also responsible for receiving and reviewing registration files for completeness and for preparing steering committee meeting agendas. the gcc was created on may 25, 1981, and its unified economic agreement was signed by its member states on november 11, 1981 in riyadh, saudi arabia. the primary objective was to achieve "coordination, integration and interconnection between member states in all fields in order to achieve unity between them" [183] . this integration plan was developed in detail during the first 20 years following the establishment of the gcc. on december 31, 2001, the gcc supreme council adopted, during its 22nd session in muscat, oman, a revised economic agreement that accelerated this integration. this revised agreement enhanced and strengthened economic ties and increased harmonization among member states. in chapter ii, the agreement defined specific areas that needed to be harmonized in order to support the gcc common market, health being one of these areas. article 12 also promotes joint projects and adoption of integrated policies between member states. having finally completed all requirements, the gcc common market was declared in december 2007 and came into force as of january 2008. this launch of the common market removed barriers to cross-country investment and service trade. gcc cooperation in the health sector began in the mid-1970s when the gcc health ministers held informal meetings such as the one held in geneva (may 16, 1975) during the general assembly of who. such cooperation was then formalized with the establishment of the conference of the health ministers of the arab countries in the gulf, which held its first meeting in february 1976. since 1991, it has been called chm. as mentioned previously, under the chm, the gcc-dr was established in 1999 to provide the gulf states with safe and effective medicines. the scope of the gcc-dr's harmonization and cooperation efforts in the pharmaceutical sector covers technical guidelines and regulatory processes. this includes the registration of pharmaceutical companies and products as well as good manufacturing practice (gmp) inspection. under the oversight of the chm, the gcc-dr steering committee is responsible for the selection and prioritization of topics, the assignment of the development of guidelines and policies, and the subsequent review and approval of the resulting recommendations. when a new topic is selected for harmonization, the gcc-dr steering committee assigns the development of the guideline/policy to either a single member state or several member states, and a technical working group is then established. the membership of this working group is at the discretion of the assigned member state(s). it may include regulatory, industry, and academic experts. technical working groups meet regularly (independently of the steering committee meetings). an annual meeting is also held with both the steering committee and relevant invited experts to discuss policy and regulations. ich guidelines are often used as reference material when developing gcc-dr guidelines. other international guidelines (including who recommendations), available national technical documents, and guidelines from other regions (e.g., eu) are also used. once developed by a working group, the draft guideline is posted on the gcc and the saudi food & drug authority (sfda) websites (http://www.sgh.org.sa and http://www.sfda.gov.sa/ en/pages/default.aspx). they are also circulated to all member states for comment. at the end of the consultation period, the working group reviews all comments received, finalizes the document, and proposes its adoption by the gcc-dr steering committee. following its adoption, the general director of the executive office submits the guideline to the chm for final approval. gcc-dr steering committee members are responsible for monitoring the implementation of the adopted guidelines in their countries. each country reports whether it encounters any problems in implementing the guidelines during an annual meeting where the gcc-dr activities are evaluated. standard practices and operating procedures have been developed to govern all steps of the harmonization process (i.e., selection and prioritization of topics, solicitation of comments, approval/ implementation of guidelines and responsibilities of the different bodies, as well as funding). additional procedures also cover the process in place for the registration of products and companies. the gcc-dr is financed by member states (using established quotas of contributions) and by registration fees. the status of its activities is communicated through its website, and also through presentations at national and international meetings, workshops, and conferences. although the executive office organizes gmp training, there is currently no official structured training program within this initiative. each member state is responsible for providing training to their regulators. the gcc-dr has initiated work on several general topics related to the development and registration of all medicinal products (gmp and gmp inspection, bioequivalence studies, stability, good laboratory practice [glp] , and clinical trials). the group also decided to harmonize practices on post-marketing activities via the development of guidelines on post-marketing surveillance (covering the counterfeiting problem) and pharmacovigilance. finally, recommendations on specific types of products (biosimilars, sera and anti-venom, vaccines, and blood products) are also under discussion. the guidelines listed above are at different stages of development (under discussion, drafting in progress, approved, or implemented). they are all based on ich, who, us fda, and/or ema recommendations. in addition to these guidelines, the gcc-dr also established a common central procedure for the registration of both the pharmaceutical companies and the pharmaceutical products. the establishment of a common system of registration and control of medicines was discussed at the first meeting of the chm in 1976. this subject was a recurrent topic of discussion until actual implementation of this procedure in 2001. since its implementation, the registration of both medicines and pharmaceutical companies has slowly transitioned from the national to the gcc registration procedure as shown in the table 6 . under this procedure, dossiers (including fees) are submitted to the gcc-dr secretariat. each country reviews the dossiers and forwards its recommendations to the gcc-dr steering committee. the committee's resolutions are adopted by the majority of the attendant members' votes (four countries is the minimum that must be represented). gmp inspection and analysis of samples by the accredited laboratories are also part of this central procedure. after the central approval, each country must adopt this central approval nationally. as mentioned above, the gcc-dr is responsible for gmp inspections, but also for the approval of quality control laboratories and for the review of technical and post-marketing surveillance reports. all these central activities increase the harmonization and integration of the pharmaceutical sector. since its creation and the signing of its initial unified economic agreement in 1981, the gcc has cooperated in many different fields (i.e., political, military, security, legal, economic, environment, and health) and developed common policies in support of achieving full integration. this integration goal was reemphasized in 2001 when the gcc supreme council adopted a revised economic agreement. in january 2008, the launch of the gcc common market marked an important step in the gcc's integration. in the health sector, cooperation began earlier. before the signature of the unified economic agreement in 1981, the health ministers had decided to cooperate in the area of health. since the initial discussions by the health ministers, many objectives have been fulfilled. the development of common guidelines, cooperation in the domain of gmps, and the establishment of a central registration procedure for companies and products are certainly the major achievements from this group. the unified purchase of drugs (i.e., common tenders concept) is also one of the most important achievements of the chm. it has ensured the purchasing of high-quality registered products from registered companies (national or international) for a more affordable price as it increased the amount of products purchased. but it has also ensured the use of the same products by all member states, which is indeed an important step in the integration process and the creation of the common market. this cooperation allows the member countries to implement common drug policies and adopt an efficient drug quality surveillance reporting system to monitor the efficacy and safety of the registered drugs [184] . recognizing all the above achievements, and despite clear increases in cooperation, the gcc has, however, not yet fully achieved its goal of unity in the pharmaceutical sector. indeed, this group has selected an integration model that will require stronger ties between countries. for example, the central registration procedure still involves national reviews and is longer than the national registration [185] . moreover, approvals delivered via this central procedure still have to be adopted by each member country. this integration process is not as advanced as in europe, where there is a rapporteur that conducts the review of the application on behalf of the group and where the ec approves drugs on behalf of all european countries. harmonization of the regulation (via both regional integration and international cooperation) is critical for this region for the following two reasons: ▸ first, this region is highly dependent on medicines developed and manufactured in other countries and regions. even if pharmaceutical companies (both international and regional) are increasing their investment in the middle east region, this region is still primarily an import-oriented market. all gcc countries share the same characteristic of being high importers of pharmaceutical products. more than 70% and 80% of pharmaceuticals consumed in oman and saudi arabia, respectively, are imported [186] . it is critical for the region to ensure that products from other countries have been developed and manufactured following acceptable standards and requirements. ▸ second, we have seen that most of the gcc-dr recommendations and guidelines are based on other international work (i.e., ich, who, etc.). the gcc is therefore dependent on the resources and expertise of these international organizations to develop its own state-of-the-art requirements and standards. the next step in the integration process of the gcc region will certainly be a better and bigger sharing of resources and expertise. the challenges of this next step will be the development of an organization and infrastructure to support such evolution. today, the regulatory expertise in the different countries is varied, with saudi arabia being the leader in the region. this country represents the biggest pharmaceutical market of the region, with approximately 65% of the pharmaceutical sales of the gcc [187], and its regulatory system is recognized as the most developed of the region. in 2010, the regulatory agency in saudi arabia, the sfda, employed 150 people in its drug sector with approximately 50 reviewers, compared to less than 10 in most of the other gcc countries. the ongoing development of a common and central system needs to ensure that the less developed countries of the regions will benefit from this cooperation without impacting the more developed countries in this sector. another challenge for this group, like for all other harmonization initiatives, is the implementation of the agreed-upon standards. the gcc needs to work on measures, including the development of a structured training program, to facilitate the implementation and follow-up of recommendations. today, the southern african development community (sadc) is comprised of 15 southern africa states, and its headquarters are located in gaborone, botswana. each of the sadc member states is at varied stages of socio-economic development, but are predominantly underdeveloped. its aggregated gross domestic product (gdp) is approximately us $457 billion, with south africa representing a significant portion of this amount. its estimated total population is approximately 250 million [188] , with an average population growth rate of 2.2% and an average fertility rate of 4.9 births per woman of childbearing age. approximately 50% of this population lacks sustainable access to affordable and quality essential medicines. the average life expectancy is 39.7 years (the lowest in the world) [189] . the sadc objectives (listed in article 5 of the sadc treaty) support regional integration and increased economic, social, and political cooperation in order to promote peace and security, economic growth, well being of the population, and protection of the environment and natural resources of the region. to achieve this major and broad objective, the sadc has launched projects and defined specific actions (e.g., harmonization of policies and creation of appropriate institutions and mechanisms). additionally, the sadc has had major milestones, such as the formation of the sadc free trade area (fta) in 2008, and set future goals, including the establishment of the common market by 2015 and the creation of a single currency by 2018. the first achievement related to the formation of the sadc fta took place on august 17, 2008 at sandton, south africa during the 28th summit of sadc heads of state and government. acknowledging that regional cooperation was critical to addressing the health problems of the region, the sadc decided to include health in its program of action. the need for harmonization of registration and control of medicines was further justified in 1999 when the disparities of legal systems and levels of development affected the implementation of a regional bulk purchasing initiative (involving five medicines used to treat tuberculosis) [190] . the sadc health program was developed taking into account global and regional health declarations and targets. to enhance this regional health integration within a legally enforceable framework, a protocol on health matters was developed. sadc also has access to the international network because it is part of the ich global cooperation group (gcg). the the summit, comprising all the heads and/or governments of sadc member states, is the highest regional authority and therefore the supreme policymaking institution of sadc. it is responsible for the overall direction and control of the community. its structure and functions are enumerated in article 10 of the sadc treaty. the summit usually meets in the member state holding the deputy chairpersonship of sadc at the time (additional meetings can also be held if necessary). the main objective of the organ on politics, defense and security, under the oversight of the summit, is to promote peace and security in the region. the structure, operations, and functions of the organ are regulated by the protocol on politics, defense, and security cooperation, which was approved and signed by the summit at its meeting in august 2001 in blantyre, malawi. since 1999, the sadc leadership has been based on the troika system, which includes the chair, incoming chair, and the outgoing chair of sadc (other member states may be co-opted into the troika if necessary). the troika represents the summit between annual meetings and makes quick decisions on behalf of sadc that are ordinarily made during the summit meetings. this system allows the organization to execute tasks and implement decisions expeditiously. it also allows the provision of policy direction to sadc programs and operations between regular sadc meetings. this troika system is applied at the summit level, but is also applicable for the organ on politics, defense and security, the council, the integrated committee of ministers, and the standing committee of officials. to support the sadc activities, a central secretariat was formed. this body is defined as the principal executive institution of sadc responsible for the coordination of the harmonization of policies and strategies to accelerate regional integration. it is responsible for the management of sadc meetings, and financial and general administration. it is also involved in strategic planning, management of sadc programs, and the implementation of decisions of sadc policy organs and institutions. one of the characteristics of the sadc is its emphasis on a decentralized institutional arrangement ( figure 2) . following previous negative experiences and failures in regional discussions, the founder states agreed that member states should be the principal players in the formulation and implementation of policy decisions. therefore in addition to the central sadc institutions, sadc national committees were established by the sadc treaty. these sadc institutions at the national level are present in each member state and include key stakeholders from government, the private sector, and civil society. their functions are (1) to provide national feedback and input in regional strategy and planning, and (2) to ensure the proper implementation of these agreed-upon regional strategies, protocols, and programs at the national level. this southern african union was created in 1980 by nine founding member states (angola, botswana, lesotho, malawi, mozambique, swaziland, united republic of tanzania, zambia, and zimbabwe) with the adoption of the lusaka declaration on april 1, 1980 in lusaka, zambia. at that time, this alliance was called the southern african development coordination conference, and its main objective was to coordinate development projects in order to lessen economic dependence on south africa, then under apartheid. the formation of this alliance was the culmination of a long process of consultations begun in the 1970s when it became clear to the leaders of the founder countries that the improvement of living standards would require regional cooperation. this cooperation was directed initially towards the political liberation of the region. following the decolonization and the political independence of southern african countries, and acknowledging the poverty and economic problems of the region, the leaders of these countries saw the promotion of economic and social development through cooperation/integration as the next logical step. on august 17, 1992 (in windhoek, namibia) , a new declaration and treaty was signed during the summit of heads of state and government. article 2 of the treaty gave a legal basis to the organization and promoted it from a coordinating conference into a development community. the sadc was then established to spearhead economic integration of southern africa. this strengthening of the integration process in southern africa was aligned with the overall african continental efforts to promote closer economic relations (as defined in the treaty signed in 1991 to establish the african economic community). in march 2001, sadc country heads of state and governments met in windhoek, namibia. during this extraordinary summit, many important decisions were made that triggered an amendment to the sadc treaty. first, the summit decided to restructure sadc institutions and to establish sadc national committees in order to facilitate the implementation of a more coherent and better-coordinated strategy. the extraordinary summit also approved the preparation of the risdp by the secretariat. the purpose of this 15-year plan (which was adopted in august 2003 and launched in march 2004) was clearly to deepen regional integration by providing sadc member states with a consistent and comprehensive program of long-term economic and social policies. this plan reemphasizes the major objectives of the organization, reviews the socio-economic indicators and challenges of the region, and analyzes all the important domains for the integration process (including health). it also provides objectives and specific targets for priority intervention areas, and specifies plans and timeframes for implementation and monitoring of its important measures. for example, in the health domain, the plan proposes to coordinate, harmonize, and monitor the implementation of regional policies and to standardize the qualification and accreditation systems. the cooperation in the health domain started in 1997 with the development of the sadc health program. three key policy documents were important in the implementation of this sadc health program: as defined in article 22 of the sadc treaty, protocols were established in each area of cooperation. these protocols spell out the objectives and scope of, and institutional mechanisms for, cooperation and integration. each protocol (which is approved by the summit and is registered with the secretariat of the united nations organization and the commission of the african union) is binding for the member states that are party to the protocol. more than 20 protocols have been developed in all domains of integration. the protocol on health [192] covers all aspects related to health (from the control of major communicable and noncommunicable diseases to the health laboratory service and institutional mechanisms). article 29 states that member states should cooperate in the harmonization of procedures for pharmaceuticals, quality assurance, and registration, and also in the production, procurement, and distribution of affordable essential drugs. the implementation plan of this protocol (which further defines and prioritizes the actions to facilitate implementation of the protocol) fixes the integration of regional regulatory processes and the establishment of a mutual recognition as a 2011-2015 past, present, and future milestone [193] . in line with the sadc health protocol, a pharmaceutical program was developed to address issues related to the access to quality medicines in all member states. this program was approved in june 2004. this sadc pharmaceutical harmonization initiative and cooperative activities include the development of technical guidelines and policies relating to the registration and control of medicines across the sadc member states. the initiative aims to improve the quality, safety, and efficacy of medicines circulating within the region, and to establish and maintain a regional shared network system for dras. the ich and who guidelines, as well as other guidelines, form the basis as reference materials for the development of regional guidelines, with agreement on the adoption of international guidelines whenever possible. potential topics for harmonization are identified at the level of the subcommittee of ministers of health, often with the input of senior ministerial health officials and mra forum experts. the process of harmonization is initiated through the sadc secretariat, which prepares and submits for decision an agenda to the ministers of health. within this context, the sadc pharmaceutical business plan was released in june 2007. this 2007-2013 plan identified priority areas, objectives, and major activities that needed to be implemented both at regional and national levels to improve access to quality and affordable essential medicines (including african traditional medicines). for example, strengthening regulatory capacity (and ensuring that fully functional dras are in place with an adequate enforcement infrastructure) and facilitation of the trade in pharmaceuticals within the regions were key strategies developed in the plan. the monitoring and ongoing evaluation of this plan (its implementation was estimated at us $16 million) was also described (see figure 3 , which explains the relationship between the different players of the plan). under the oversight of the ministers of health, a group of designated senior officials monitored the implementation of the plan via the establishment of technical subcommittees or task teams. this group of senior officials (from the health departments of each member state) was also supported by the secretariat. the sector of the secretariat responsible for supporting the operations of the pharmaceutical harmonization initiative takes place under the directorate of the shd&sp. national health ministries also play a significant role (by coordinating and leading the implementation of programs at the national level), and report on progress through their sadc national committees. finally, other stakeholders (e.g., professional associations, research institutions, dras, etc.) are also involved and requested to provide expertise and feedback on specific actions of the plan. in 2004, the medicines regulatory forum was created as a technical subcommittee to promote the harmonization and enhancement of the pharmaceutical regulations in the region. this standalone committee is made of the heads of the national regulatory bodies. the sadc has released guidelines on several topics. these guidelines regulate the following general areas: ▸ the conduct of clinical trials: these guidelines provide a framework (information to be submitted, review process, etc.) and refer to the entire ich gcp (this is not a replacement or subimplementation of the ich gcp). ▸ registration of medicines: "guidelines for submitting applications for registration of a medicine" were released in 2007. an application form is also available. ▸ good manufacturing practices. ▸ pharmacovigilance (only basic rules are provided). ▸ advertising. ▸ recalls. ▸ registration of nutritional supplements, vaccines, and traditional medicines. ▸ bioavailability and bioequivalence. ▸ stability studies. ▸ import/export (with an emphasize on gmp). most of the above guidelines are based on, or cross-reference, ich and who guidelines and recommendations. these international bodies provide much of the technical assistance to sadc initiatives. when they exist, national rules and requirements are also used (e.g., the gcp requirements from south africa). guidelines have also been developed to cover the following topics that are of specific interest for the region: ▸ pharmaceutical wholesale ▸ hiv vaccine clinical trials ▸ donations of pharmaceutical products it should be noted that the sadc efforts in the pharmaceutical area include african traditional medicines. these products are an important part of the healthcare environment of these countries. one of the cooperation projects is to establish a regional databank of traditional medicines and medicinal plants, and to develop regional policies and legal frameworks for the practice of these traditional medicines. finally, sadc is trying to establish a joint procurement system and to harmonize standard treatment guidelines/lists among countries. these two actions will facilitate the use of the same medicines within the region and therefore allow further harmonization of the pharmaceutical environment. since its inception in april 1980, sadc has demonstrated that regional cooperation and integration is possible and useful for southern africa. one of the foremost achievements of sadc has been to put in place a regional program (the sadc programme of action) with numerous projects covering cooperation in various economic sectors. the formation of the sadc fta on august 17, 2008 was an important first step in this ongoing integration process. the overall and ultimate goal of sadc is integration by 2020; this is a very ambitious plan. presently, the level of cooperation varies for each area. in some areas, this cooperation only aims to coordinate national activities and policies. in others, the cooperation goes towards real integration. for example, on foreign policy, the main objective is coordination and cooperation, but in terms of trade and economic policy, a tighter coordination is in progress with a view to one day establishing a common market with common regulatory institutions. in the health and pharmaceutical domain, many harmonization projects have been established despite challenges. indeed, as recognized in the sadc pharmaceutical business plan, the region has many weaknesses, such as weak regulatory systems (leading to many unregistered products), lack of adequate capacity and trained personnel, outdated medicine and intellectual property laws, and noncompliance to gmp (leading to inadequate availability of medicines and poor and inconsistent quality of these medicines in some member states). even if there is a political will, it is very difficult for the authorities of this region to resolve this situation as they are confronted by two major problems: ▸ the management of major diseases (such as hiv/aids, tuberculosis, malaria, etc.) ▸ the lack of adequate resources and finances to support all health initiatives the combination of the two above problems, common to all developing countries, slows down the development of other health activities. all the efforts and resources in the domain of health are rightfully dedicated to the prevention and treatment of the major public health concerns. activities such as the development of adequate regulatory function and framework or the development and harmonization of pharmaceutical requirements are therefore negatively impacted. even if all sadc member states have national medicine policies, legislation, and regulation in place, some of these policies have been draft documents for many years (up to 15 years). a number of the laws date back from the 1960s (some even to the 1930s). it is clear that such policies and legislation need revisions to include recent developments and meet current standards in public health and medicines. such revisions and updates would help the implementation of the sadc harmonized recommendations and guidelines. however, despite the numerous weaknesses and problems that the region faces, the sadc was able to promote cooperation between member states in order to improve access to quality medicines. there have been several major accomplishments in the development and harmonization of pharmaceutical requirements, such as the development of pharmaceutical guidelines for the registration and control of medicines, the establishment of the pharmaceutical business plan, and the establishment of the "medicines regulatory forum." moreover, the sadc has now analyzed (with its pharmaceutical business plan) the weaknesses, opportunities, and overall priorities in the pharmaceutical domain (i.e., regulation and control of medicines). the road map includes the assessment and strengthening of dras (work performed in collaboration with the who), combat against the spread of counterfeit medicines, the development of regional training programs, and the establishment of accredited quality control (qc) laboratories. to support this road map and other areas of harmonization, the structure of the sadc institution will certainly have to be modified (as done in the past). in order to be successful, sadc will also need to continue to work with external organizations. support and technical assistance from ich and who will continue to be critical. but, communication and cooperation with other groups and regions (e.g., the new partnership for africa's development [nepad]) will also be necessary to coordinate the efforts on the entire continent and share the available resources, financial support, and expertise. this is especially important because some sadc members are also part of other african subregional initiatives. finally, the next important phase for sadc is the implementation of the agreed-upon standards, recommendations, and plans (e.g., how will the proposed actions to "strengthen national dra capacity to implement harmonized sadc guidelines" be managed?). implementation is a challenge for all harmonization initiatives. this is especially true for this region due to all the weaknesses carried by these countries and the lack of resources and finances. however, the lack of appropriate regulations in some countries may paradoxically become an opportunity; the coordination of the development of the regulation (based on the who and ich recommendations) can be viewed as an a priori harmonization. moreover, it is interesting to note that the sadc structure presents a specificity not found in other harmonization initiatives. in addition to the standard centralized bodies (i.e., summit, council of ministers, committee of senior officials, central secretariat, etc.), the sadc has established national committees. these national sadc contact points could become critical for this implementation phase. this unusual model may also be useful for other worldwide initiatives. the association of southeast asian nations (asean), established in 1967, has very broad objectives. the aims and purposes of the association, stated in its declaration, include: ▸ the acceleration of economic growth, social progress, and cultural development in the region through joint endeavors in the spirit of equality and partnership in order to strengthen the foundation for a prosperous and peaceful community of southeast asian nations ▸ to promote regional peace and stability through abiding respect for justice and the rule of law in the relationship among countries in the region ▸ to promote active collaboration and mutual assistance on matters of common interest in the economic, social, cultural, technical, scientific, and administrative fields ▸ to provide assistance to each other in the form of training and research facilities in the educational, professional, technical, and administrative spheres ▸ to maintain close and beneficial cooperation with existing international and regional organizations with similar aims and purposes, and explore all avenues for even closer cooperation among them the asean region has a population of approximately 590 million, a total area of 4.5 million square kilometers, a combined gross domestic product (gdp) of us $1,500 billion, and a total trade of about us $1,500 billion [194] . its estimated annual pharmaceutical imports and exports is us $9.5 billion [195] . among the three pillars of the asean community (political-security, economic, and socio-cultural) agreed upon by the asean leaders in the declaration of asean concord ii (signed on october 7, 2003 in bali, indonesia), the establishment of a single market by 2020 is an important goal. its objective is to allow the creation of a stable and prosperous asean economic region in which there is a free flow of goods, services, and investments in order to reduce poverty and socio-economic disparities. at the 12th asean summit in january 2007, the leaders affirmed their strong commitment to accelerate the establishment of an asean economic community (aec) by 2015 and signed the cebu declaration on the acceleration of the establishment of an asean community by 2015. in 1992, in moving towards this ultimate goal, asean launched the asean free trade area (afta) and defined priorities (e.g., healthcare) where regional integration should be accelerated. one of the basic criteria to support afta, and ultimately a single market, is the harmonization of standards and regulations. therefore, recognizing the importance of the harmonization of standards to facilitate and liberalize trade and investment in the region, asean has established the asean consultative committee on standards and quality (accsq) to harmonize national standards with international standards and implement mutual recognition arrangements on conformity assessment to achieve its end goal of "one standard, one test, accepted everywhere." the accsq monitors the harmonization of standards and regulations in many different areas (i.e., pharmaceutical products, but also cosmetics, medical devices, food, electrical and electronic equipment, automotive products, wood-based products, etc.). harmonization in the pharmaceutical area is coordinated by the pharmaceutical product working group (ppwg). the objective of this group is to harmonize the technical procedures and requirements applicable to the asean pharmaceutical industry in the region, taking into account other regional and international developments on pharmaceuticals. since 2003, asean has been a member of the ich global cooperation group (gcg). this membership helps asean to become an important component in the global harmonization process, as it constitutes a way to disseminate the ich recommendations on drug regulatory harmonization. it also ensures that asean specificities and challenges will be considered when new global recommendations are discussed. the the highest decision-making body of asean is the meeting of the asean heads of state and government (the asean summit) that is convened annually. additional ministerial meetings are also held regularly. committees of senior officials, technical working groups, and task forces have been created to support the asean summit and ministerial meetings and conduct the agreed asean activities. the accsq was established to coordinate the harmonization of national standards with international standards. this committee reports to the asean senior economic official meeting (seom) that is under the supervision of the asean economic ministers (aem). the ppwg, under the supervision of the accsq, was created to coordinate the harmonization activities related to the pharmaceutical area. the scope of activities of the ppwg includes the following: ▸ exchange information on the existing pharmaceutical requirements and regulations implemented by each asean member country. ▸ review and prepare comparative studies of the requirements and regulations. ▸ review the harmonized procedures and regulatory systems currently implemented in others regions in order to develop harmonized standards, regulations, and procedures for the region. for each specific topic selected for harmonization, the ppwg sets up ad hoc committees and assigns one of the member states as the project leader. membership of the ad hoc committee is on a voluntary basis. the core members of the ppwg are the chair and co-chair, representatives from the dras from each asean member state, a representative from the asean secretariat, as well as representatives from pharmaceutical industry associations. delegates from additional member states can also participate in ppwg meetings as observers. in addition, accsq members and invited experts may attend the annual ppwg meeting. the ad hoc committee meets prior to the ppwg meetings. additionally, the ppwg operates through self-sponsorship (i.e., each member state is responsible for its own funding for traveling or hosting meetings). who has also contributed to the process in the past. ppwg activities are supported by the asean secretariat, which was established on feburary 24, 1976 to coordinate the asean branches and to implement asean projects and activities. in 1992, the mandate of the asean secretary-general was enlarged to initiate, advise, coordinate, and implement the agreed-upon asean activities. finally, it should be noted that another working group, the asean working group on pharmaceuticals development (awgpd) (under the supervision of the asean health ministers meetings), also participates in the regional harmonization of pharmaceutical regulations through its activities on traditional medicines, good manufacturing practices (gmps), good clinical practices (gcps), counterfeiting drugs, and pharmacovigilance [196] . asean was officially established with the signature of its declaration (the bangkok declaration) on august 8, 1967 in bangkok, thailand by the five original member countries (i.e., indonesia, malaysia, philippines, singapore, and thailand). brunei darussalam joined on january 7, 1984, vietnam on july 28, 1995, laos and myanmar on july 23, 1997, and cambodia on april 30, 1999. the accsq was formed in 1992 to facilitate and complement the afta. efforts towards specific harmonization of pharmaceutical regulations have been initiated by the accsq since 1992. the pharmaceutical product working group was then established in september 1999 in kuala lumpur, malaysia following a decision by the accsq during its 13th meeting (march 1999 in manila) . during its inaugural meeting during september 6-7, 1999, the ppwg formulated its terms of reference and set up a work plan (i.e., goals, strategy, activities, expected output, and status). subsequent meetings focused on the status review of ongoing harmonization activities, and discussion and adoptions of final recommendations. the asean also decided to develop relationships with other countries. they developed "bilateral agreements" with a number of countries (canada, india, the us, the russian federation, pakistan, etc.), other regions (europe, gcc, sadc, andean group, mercosur), and international organizations (united nations, unesco). but one of the most important developments was the creation of the "asean plus three" cooperation to promote the east asia region. this cooperation began in december 1997 with the convening of an informal summit among asean leaders and their counterparts from east asia, namely china, japan, and the republic of korea. it was then formalized in 1999 with the issuance of a joint statement on east asia cooperation at the 3rd asean plus three summit in manila, philippines. the asean plus three leaders expressed confidence in further strengthening and deepening east asia cooperation at various levels and areas, particularly in economic, social, political, and other fields. public health and harmonization of standards are topics under discussion among others. several bilateral economic arrangements have already been signed, and may be the basis for the possible establishment of an east asia free trade area in the future [197] . in november 2007, two important documents were ratified: ▸ first, the asean charter which spells out the principles to which all 10 member states adhere to was signed. this legal framework, which entered into force on december 15, 2008, serves as a firm foundation in formulating the asean community by providing legal status and an institutional framework for asean. it also codifies asean norms, rules, and values, sets clear targets for asean, and presents accountability and compliance. ▸ second, the asean leaders also signed the declaration on the asean economic community (aec) blueprint that provides the elimination of forms of nontariff measures and market access limitations in order to transform asean into a single market. the draft guidelines developed by the ad hoc committees are reviewed, discussed, and then adopted, by consensus, during the ppwg meeting. these standards are then endorsed by the accsq. the ppwg harmonization process includes the following steps: ▸ exchange and review of information on existing pharmaceutical requirements and regulations of the member states. ▸ compare the requirements and regulations to identify key areas for harmonization. ▸ create an ad hoc committee (and assignment of a lead country) to prepare the draft "harmonized product," which most of the time is based on guidelines or recommendations already available (in one of the asean countries, internationally, or in another regions). ▸ circulate the draft to all member states for comments. ▸ consolidate comments into the revised draft. ▸ discuss and adopt (by consensus agreement) the draft by the ppwg. ▸ endorsement of the document and recommendation by the accsq. ▸ dissemination of the adopted documents (via the asean website or seminars/ meetings). ▸ compulsory implementation of the recommendation by the member states. in order to organize, coordinate, and monitor the implementation of the agreed-upon recommendations and guidelines, the ppwg set up a specific task force and working group to focus on a mutual recognition arrangement (mra) and implementation. they developed a standard operating procedure (sop) and plan of action. they also assessed the status of the implementation of requirements (i.e., adoption into the national systems) in order to develop appropriate training (to government and industry) to increase understanding of the asean guidelines and fill the gaps among the member states. the first project of the asean ppwg was to compare the existing product registration requirements for pharmaceuticals of asean member countries in order to help define key areas for harmonization. this report was finalized in 1999. following this assessment, the group developed the asean common technical requirements (actrs) for pharmaceutical product registration in the asean region. these requirements are sometimes based on the existing national requirements, who guidelines and recommendations from other regions (e.g. the asean guidelines for "the conduct of bioavailability and bioequivalence studies" were created from the ema/cpmp note for guidance). but most of the asean actrs have been developed via the adoption or modification of the ich guidelines. they cover all the quality, nonclinical, and clinical aspects already developed by ich. labeling requirements, administrative data (i.e., certificate of pharmaceutical product (cpp), letter of authorization, application forms, etc.), and the glossary have also been discussed. the final actrs were endorsed by the accsq at its 21st meeting (in march 2003) . guidelines to actr (e.g., process validation and stability) have also been developed. the group also developed an asean common technical dossier (actd) for pharmaceutical product registration. like the ich ctd, this initiative reduces the time and resources needed to compile applications for registration in different countries. regulatory reviews and communication with the applicant is also facilitated by a standard document of common elements. this actd is based on the ich ctd, but is organized into four parts only (the overview and summaries are included at the beginning of the relevant parts i, ii, and iii instead of being grouped under a separate section as in module 2 of the ich ctd): ▸ part i: activities have also been conducted in the area of gmps. on april 10, 2009, the asean economic ministers (at the 14th asean summit and related summits in pattaya, thailand) signed the asean mra for gmp inspection of manufacturers of medicines. this arrangement establishes the mutual recognition of gmp certifications and/or inspection reports (issued by inspection bodies) that will be used as the basis for regulatory actions such as granting of licenses and supporting post-marketing assessment of conformity of these products. the ppwg also worked on a bioavailability/bioequivalence study reporting format and a post-market alert system. the objective of the asean post-marketing alert system is to share information relating to defective or unsafe medicines, and also cosmetics, health supplements, and traditional medicines. this pilot project was launched in april 2005 and then adopted by the ppwg in february 2006. the two major accomplishments of the ppwg are the actd and the atcrs. the actd is the common format for marketing authorization application dossiers, while the atcrs are the set of written materials intended to guide applicants to prepare application dossiers in a manner that is consistent with the expectations of all asean dras. a series of guidelines for the implementation of the atcrs is being finalized. most of the asean recommendations strictly follow the ich guidelines and recommendations. indeed, asean is a good example of the influence of the ich outside the ich regions and of the integration and implementation of ich standards outside ich frontiers. beyond these harmonized technical aspects of the pharmaceutical product registration that need to continue, the ultimate goal of the asean ppwg is clearly to implement a system where countries fully cooperate in enhancing mutual regulatory capacities and resources. with the ongoing challenges posed by the globalized economy, and in particular the huge economic growth of china and india, which may have specific impacts on the region, this association of countries is clearly committed to full integration (with the goal to establish an asean economic community by 2015) and moving towards the european community model. the ultimate steps in the pharmaceutical harmonization process will certainly be the development of asean pharmaceutical directives, the development of a pan-asean registration process (with a centralized procedure), and the establishment of an asean regulatory agency. but the full implementation of this supranational system will take time. it will only be possible when the asean has developed common legislation and structure (i.e., commission, parliament, etc.), as in europe. the harmonization of pharmaceutical regulations can, however, continue before such an organization is in place. the next logical step is the creation of an mra procedure. indeed, this type of procedure is not binding for the countries (and therefore does not require common legislation) and requests only a "facilitator body" and not a supranational evaluation agency. this procedure would be similar to the old "multi-state" procedure that europe established in 1975 as a first step towards the creation of the system that we know today. asean is also committed to increased relations with external partners. the creation of the asean plus three cooperation may indeed promote the harmonization of pharmaceutical regulations in the much broader asia region. outside the region, asean and its ppwg clearly want to increase relationships and cooperation with other regional organizations, and also international bodies (i.e., un, who, ich). this development, which is outside its current framework, could indeed strengthen this initiative by increasing its exposure on an international basis, therefore allowing this organization to play a pivotal role in the international community. the asia-pacific economic cooperation (apec) is a forum, established in 1989, to facilitate economic growth, cooperation, trade, and investment in the asia-pacific region. this region accounts for approximately 40% of the world's population, approximately 54% of world gross domestic product (gdp), and about 44% of world trade [198] . since its creation, this intergovernmental grouping has worked to reduce tariffs and other trade barriers across the asia-pacific region in order to liberalize trade and investment and facilitate business within the region. apec also works to create an environment for the safe and efficient movement of goods, services, and people across borders in the region through policy alignment and economic and technical cooperation. to support its "three pillars" (i.e., trade and investment liberalization, business facilitation, and economic and technical cooperation), apec has been active in a broad range of more than 50 topics (from fisheries, agriculture, and tourism to terrorism, finance, and intellectual property). this broad range of topics, under which hundreds of specific projects have been developed, reflects the complex factors and issues related to economic development, growth, and the pursuit of open trade and investment for a region. several of these topics can influence the health and pharmaceutical sector (such as intellectual property or science and technology), but two specifically focus on this area: ▸ the health topic, managed by the "health working group," focuses mainly on the prevention and management of infectious diseases (naturally occurring or due to bioterrorism) in the region. this working group is not involved in the discussion related to pharmaceutical regulation. ▸ the life sciences topic, managed by the life sciences innovation forum (lsif), addresses key challenges in the health and pharmaceutical sector in order to create the right policy environment for life sciences innovation. the harmonization of standards and the regional and international cooperation are two of the tools used to achieve the objectives. as a member of the ich global cooperation group (gcg) since 2003, apec lsif promotes the implementation of the ich guidelines through its workshops. it also keeps ich informed on the status of the different ongoing initiatives in the region. apec has 21 member economies from the broad asia-pacific region, which spans four continents (plate the 21 members of apec recognize that strong economies and harmonization initiatives are not built by governments alone, but by partnerships between government and its key stakeholders, including industry, academia, research institutions, and interest groups within the community. therefore, apec actively involves these key stakeholders in the work of the forum. at the working level, representatives from the private sector are invited to join many apec working and expert groups. this process provides an important opportunity for industry to provide direct input into apec's ongoing work. apec has official observers, the association of southeast asian nations (asean) secretariat being one of them. these observers participate in apec meetings and have full access to documents and information. apec operates as a cooperative, multilateral economic, and trade forum. apec policy direction is provided by apec leaders from the member economies. the life sciences innovation forum (lsif), under the committee on trade and investment, is a tripartite forum involving representatives from government and academia, and also from industry. it brings together scientific, health, trade, economic, and financial considerations to create the right policy environment for life sciences innovation. all the apec activities are supported by the apec secretariat, which is based in singapore and operates as the core support mechanism for the apec process. it provides coordination, technical, and advisory support, as well as information management, communication, and public outreach services. the idea of apec as a cooperative to enhance economic growth and prosperity, and to strengthen the asia-pacific community, was first publicly mentioned by the former prime minister of australia (bob hawke) during a speech in seoul, south korea in january 1989. later that year, 12 asia-pacific economies met in canberra, australia to establish apec. in november 1994, apec's vision was reiterated by apec economic leaders during their meeting in bogor, indonesia. during this meeting, the economic leaders adopted what are referred to as the "bogor goals." these goals of "free and open trade and investment in asia-pacific no later than 2020" were based on a recognition of the growing interdependence of the economically diverse region, which comprises developed, newly industrializing, and developing economies. due to the heterogeneity of the region, it was agreed that the pace of implementation would take into account differing levels of economic development among apec economies. in 1995, a framework for meeting the bogor goals (referred to as "the osaka action agenda") was adopted. this action plan focused on three key areas: ▸ trade and investment liberalization ▸ business facilitation ▸ economic and technical cooperation following this first action plan, several other plans have been adopted over the years to support the implementation of the bogor goals. specific topics (such as climate change and severe acute respiratory syndrome [sars]) were also discussed. recognizing the global financial crisis as one of the most serious economic challenges ever faced, the leaders highlighted the importance of reducing the gap between developed and developing members. this meeting included discussions related to regional economic challenges (implementing a structural reform and food supply and price), the social dimension of globalization, the enhancement of human security in the region, and the problem of climate change. the lsif and the health working group held their first joint meeting in march 2011 in washington, dc, us to explore possible areas of cooperation. this meeting followed the 2010 recommendations of the apec senior official endorsing a new terms of reference for the steering committee on economic and technical cooperation. it was then agreed that the role and operations of the health working group would be reviewed with a view to merge, disband, or reorient this body. the lsif leads the activities related to the regulatory convergence in the pharmaceutical area within the asia-pacific region. both apec and the lsif have recognized the benefits of convergence related to the pharmaceutical standards within the region. to achieve this goal, these two groups rely on other regional and global harmonization initiatives. indeed, the lsif is working towards the adoption and implementation of existing harmonized international guidance and regulatory best practices. it also provides the ability to access funds to advance projects. unlike asean, the objective is not to proactively develop specific regional harmonized guidance. this practice is in line with the overall apec goals to facilitate cooperation and trade in the region, and to operate on the basis of nonbinding commitments and open dialogue. as already mentioned, apec has no treaty obligations required of its participants, and there is no plan for integration (unlike asean, which follows an integration model like europe). recognizing this specific context, the objective of lsif is "regulatory convergence" with gradual alignment over time between member economies. the distinction with "regulatory harmonization" is that "regulatory convergence" does not typically involve or require active harmonization of regulations that would be unrealistic within the apec environment. the objectives and priorities of the lsif, listed in its strategic plan approved by the apec ministers in 2004, are very broad. this plan includes recommendations on four different sectors: research, development, manufacturing and marketing, and health services. the goal was to develop recommendations that would contribute to a more efficient, effective, and coordinated policy approach to support innovation and health in the region. these recommendations have applications in many different areas (legal, finance, scientific, regulatory, infrastructures, etc.). one of the recommendations from this strategic plan follows: "harmonization of standards for life sciences products and services and mechanisms for collaboration and exchange of information among economies were recognized as critical elements" [199] . the principle was to review policies, standards, and regulatory mechanisms against international best practices in order to move towards regional convergence. the objective was also to achieve close collaboration and to facilitate the use of international standards and global best practices through collaboration with outside bodies such as the ich gcg. the lsif has been very active in sponsoring a series of workshops on anti-counterfeiting, ich quality guidance, clinical trials, and good clinical practice (gcp) inspection. however, it has been recognized that the lsif has not been used to its full potential to promote regulatory convergence and cooperation compared to some other rhis [200] . what was missing was the engagement of regulators and the appropriate industry people in this equation, together with the lack of a more focused strategic framework and multiyear plan for medical products. in 2008/2009, acknowledging the lack of strategic and effective approaches, the lsif decided to react and strengthen its organization: ▸ in june 2009, the lsif took an important step towards harmonization by establishing, in seoul, south korea, the apec harmonization center (ahc). this followed a proposal from south korea in august 2008 (at the apec lsif vi in lima, peru) that was endorsed by the apec leaders in november 2008 in a joint ministerial statement. as an lsif organization, this center has its own structure (including a director, a secretariat, and an advisory board of lsif experts), and also its own website (www.apec-ahc.org). this organization includes representatives from government, industry, and academia. its mandate is to provide a platform to address and solve priority concerns of apec members on regulatory convergence. following the establishment of the ahc, several workshops took place. in general, they focused on the regional regulatory convergence, but also discussed specific problems such as multiregional clinical trials and the biosimilar concept. the purpose of these workshops is to allow government, regulators, academics, and the pharmaceutical companies to discuss and exchange information and views on the harmonization of standards. funding and support from the ahc has allowed for the delivery of more than a dozen workshops since june 2009. ▸ in addition to the ahc, apec also decided to establish a regulatory harmonization steering committee (rhsc) within the lsif structure to strategically coordinate regulatory convergence in the region. the rhsc brought together senior officials from regulatory authorities and representatives from industry coalitions. this committee provides leadership and direction on regulatory priorities. during its inaugural meeting in seoul, south korea in june 2009, the rhsc discussed and finalized its terms of reference and started to identify priority projects. since then, the rhsc has initiated several projects and developed a strategic framework on regulatory convergence of medical products by 2020 to coordinate activities [201] . since the creation of the apec ahc and rhsc, considerable progress has been made with the design, development, and implementation of a more strategic, coordinated, and sustainable approach. this includes the strategic framework and the creation of priority work areas (pwas), each of which is associated with a roadmap that defines an overall strategy to achieve the ultimate goal of greater regulatory convergence by 2020 in the area of medical products. each project or activity undertaken must now support the roadmap and in turn move apec closer to the 2020 goal. this is a better-structured organization that moves away from individual, uncoordinated activities and workshops to a more directed, coordinated approach with parties and individuals that are in a position to effect change and commit resources. the workshops, organized and funded by the ahc and led by the rhsc membership, are now tied to a directed roadmap and strategic framework representing the collective efforts and commitment of many economies. these workshops served as a diagnostic of issues, challenges, and opportunities associated with a particular area of focus, with recommendations coming back to the rhsc for consideration. all workshops are championed by the regulators of various apec economies (for example, the us for medical product quality and supply chain integrity, korea for biotechnological products and pharmacovigilance, singapore for cellular-and tissue-based therapies, chinese taipei for good review practices and combination products, and thailand for gcp inspections). finally, this organization is partnering with other regional and international players in an effort to promote synergy and more effective use of resources. a good example here is the supply chain roadmap. this is a global issue and requires a global, coordinated approach. the rhsc roadmap is being implemented through the direction of an oversight committee that includes the who, ema, edqm, and the dra of nigeria. in doing so, apec takes account of and complements like initiatives, and can serve as a catalyst to global action. up to now, the apec did not proactively develop guidance or harmonized standards and requirements. the objective is to promote convergence via the dissemination of international harmonized information and recommendations (i.e., ich guidelines). to achieve these goals, the group has developed and funded several projects. in 2008, the lsif released an "enablers of investment checklist," a voluntary guidance tool for member economies to assess and improve their innovative life sciences sector investment opportunities. one of the six principles covered by the checklist is "efficient and internationally harmonized regulatory systems." under this principle, the lsif promoted the development and implementation of focused efforts on harmonization towards international standards through recognized international organizations (i.e., ich). moreover, to support this objective, the lsif also proposed development of the following: ▸ a regulatory framework (transparent, predictable, and science-based) that allows for the quick introduction of new innovative products ▸ an efficient clinical trial regulatory system focused on safety, efficacy, and ethical standards ▸ an adequate number and level of training programs for regulatory personnel ▸ the publication of proposed regulations for stakeholder comments (which should be taken into account) ▸ laws providing for stakeholder consultation throughout the regulatory drafting and review process ▸ participation in international joint clinical trials performance metrics have also been defined to assess the implementation of the recommendations. finally, some of the other principles on this checklist also support cooperation and convergence as they assess the resources, exchange programs, intellectual property rights, and interagency coordination of life science policy and regulation. in addition to the "enablers of investment checklist," lsif has also developed projects focusing on specific topics of interest, such as: ▸ clinical trials: the area of clinical trials was selected as one of the lsif priorities in its strategic plan. assessment and improvement of the clinical trial system and regulation in each country has also been recommended in the lsif "enablers of investment checklist." the goal was to put in place an effective regulation infrastructure (by harmonizing regulatory practices and policies according to international best practices and standards). this activity includes work on regulatory process and framework (incorporating interagency review of new policies, guidances, and regulations), implementation and promotion of good clinical practices (gcps)/good manufacturing practices (gmps), protection and enforcement of intellectual property, establishment of clinical trials registries, and implementation of ich recommendations. to implement this goal and strengthen the dras' capacity to harmonize practices, a first workshop on "review of drug development in clinical trials" was held in march 2008. several additional workshops concerning clinical trials and gcp (including clinical research inspection) have since been set up on this subject. the first workshop organized by the ahc in 2009 focused on the opportunities and challenges of multiregional clinical trials. each of the workshops serves to refine recommendations and showcase the china-japan-korea tripartite research initiative that is exploring possible ethnic differences between the three countries. as a result of workshops, two roadmaps have been developed: one for gcp inspection (under the leadership of thailand), and one for multiregional clinical trials (under the leadership of japan) [202] . the focus will address gaps and needs not addressed by any other institution or regulatory authority to date. ▸ counterfeit medicines: another area of interest for lsif has been the increase in counterfeit medicines in the region. a series of seminars and workshops have been organized since january 2008 to examine ways to combat this problem. the lsif has also developed an anti-counterfeit medical product action plan. the objective of this plan is to share best practices in the detection and prevention of counterfeits to both dras and industry professionals, and organize systems to reduce the threat and occurrence of counterfeit medicines. finally, it is important to note that apec also promotes capacity building for its members. this objective is met through the organization of workshops, training courses, and seminars that enable people, businesses, and government departments to improve their skills and knowledge [204] . the primary focus of apec is clearly the economy, and its objectives center on the facilitation of trade and business between member economies (with no integration plan). the asia-pacific region has consistently been one of the most economically dynamic regions in the world. since the establishment of apec in 1989, the total amount of trade has grown significantly [205] . apec's work under its three main pillars of activity has helped drive this economic growth. in 2010, apec conducted an assessment to determine what progress has been made against the bogor goals of free and open trade and investment. the results were positive, showing that member economies have taken concerted action and progressed in a wide array of economic, trade, investment, and social areas. average tariffs in the region have been reduced from about 17% in 1989 to approximately 5.8% in 2010. nontariff barriers have also been reduced thanks to apec's work on trade facilitation. this progress by apec towards the bogor goals contributed to a more than five-fold increase in members' total trade (goods and services) between 1989 and 2010 (from us $3.1 trillion to us $16.8 trillion). finally, these activities contributed to real benefits for people across the entire asia-pacific region. over the span of 10 years, from 1999 to 2009, poverty was reduced by 35% (poverty levels are measured by calculating the population living on less than us $2 a day) [206] . apec represents a large region and approximately 40% of the world's population. this is obviously an advantage in facing the challenge of globalization. however, this size and magnitude can also be a disadvantage in terms of management. indeed, this region is very heterogeneous with countries at the two extremes of the development spectrum (i.e., very developed and very undeveloped countries). due to this disadvantage and the heterogeneity of this large region, it is difficult to adopt a treaty and to impose obligations on these members. for this reason, apec operates on the basis of nonbinding commitments where each country has the choice to implement the decisions. the implementation of economic measures (i.e., reduction of taxes and trade barriers to increase trade between members) is possible since it can quickly benefit all members. however, the lack of a treaty or obligations on members can sometimes be more challenging for more drastic long-term reforms (i.e., the harmonization of standards), as member economies have different priorities. the diversity of the apec region means that member economies will gradually move closer together in requirements and approaches, but not everyone will implement the measures at the same time. capacity and local realities must be taken into account. though technical cooperation is part of apec's objectives (i.e., apec is very involved on specific topics such as climate change), it is the second priority behind economic development. the health topic, managed by the health working group and the life science innovation forum, has clearly been funded because this topic has an impact on the economy. as stated on the apec website, "life sciences innovation is critical to growth and socio-economic development as healthy people produce healthy economies. efficient and effective delivery of patient focused products and services can improve a population's longevity, wellness, productivity and economic potential" [207] . however, even if the above challenges are important, very positive outcomes have to be noted in terms of regulatory convergence in the pharmaceutical area. indeed, this organization supports convergence via the funding of projects and workshops. lsif was able to focus its effort on projects that impact all member economies (developed or developing), such as the coordination of multicountry clinical trials, the implementation of gcps, the quality of medicines, the counterfeit medicines problem, and the emergence of biosimilars. lsif also creates a forum that allows exchange of information between very different countries and between all the players (regulators, industry, and academia). this communication and dissemination of harmonized standards is very important, and is as essential as the development of the standards itself. in 2008/2009, acknowledging a lack of strategic coordination, apec and lsif decided to better organize the activities. first, they established the ahc to facilitate the exchange of information and the creation of a network. second, they created the rhsc to strategically coordinate regional convergence. since this revision of lsif's structure and the creation of these two supporting bodies, significant progress has been made and apec has since declared that further harmonization to "achieve convergence on regulatory approval procedures" is targeted for 2020 [208] . to support this goal, many important projects have been initiated on critical topics, such as product quality and supply chain integrity [209] , good review practices [210], gcp inspection [211], pharmacovigilance [212] , biotechnology products [213], etc. all these changes and projects today represent great promise for this region, and the tools to be developed could also support global cooperation and convergence. the challenge is now to implement the plan and to continue to coordinate the projects in order to achieve the desired objectives. the recent establishment of the rhsc regulatory network (including dras not currently part of the rhsc) will certainly support the implementation of agreed-upon measures. many different types of bilateral cooperation have been established over the years. lll it would be difficult to list and discuss them all as several dozen exist. however, all these types of bilateral cooperation and agreements can be grouped into three categories based on their scope and objectives: ▸ cooperation between two developed countries: the objective of such cooperation is to exchange good practices and harmonize standards to avoid duplication of efforts (e.g., for orphan drugs). for example, the eu and the us developed a privileged relationship and the exchange of officials and staff between us fda and eu authorities allow for a closer collaboration, exchange, and therefore better understanding of each other. ▸ cooperation between one developed country and one developing country: this type of cooperation focuses on training, mentoring, and support from the developed country to the developing country. the objective is indeed to build expertise and capacity in the developing country based on the experience of the developed country. for example, the us fda has established several agreements with developing countries (e.g., brazil, mexico, south africa, taiwan, etc.) ▸ cooperation between two developing countries: by pooling experience and resources, two countries can better tackle issues of common interest. this type of cooperation allows for better allocation of sparse resources, and also increases interest for pharmaceutical companies (two small markets with different requirements would be less attractive to industry). for example, brazil has cooperation projects with cuba, dominican republic, mozambique, and several other countries [214, 215] . one of the most advanced bilateral collaborations is between australia and new zealand. it represents a good example of a bilateral cooperation and harmonization model working towards a full integration of systems. indeed, after several years of convergence and harmonization, australia and new zealand agreed to establish a joint australia new zealand lll bilateral cooperation can involve two countries, but it can also mean the collaboration of a regional entity with another party. for example, the european union has been collaborating with australia, canada, the us, and japan, but also with the gcc group. therapeutic products agency (anztpa). this new agency will ultimately replace australia's therapeutic goods administration (tga) and the new zealand medicines and medical devices safety authority (medsafe). during the first meeting of the anztpa implementation ministerial council (melbourne, january 28, 2012), ministers from both countries agreed on key elements to establish the joint trans-tasman agency, and also how the joint regulatory scheme will be organized over a five-year period [216-1]. since then, the framework of the anztpa is under discussion . this cooperation/harmonization initiative was begun with the objective of sharing expertise and resources in order to provide health benefits for consumers by creating a world-class scheme. it is also expected that this single approval process for both countries will increase efficiency, improve the standards of medicines produced in the two countries, reduce regulatory costs for industry, and facilitate further economic integration [217] . this initiative is a great example of successful bilateral harmonization and cooperation, and emphasizes the importance of a staged approach for this type of project. it also shows that such ultimate integration of systems is challenging. indeed, the agreement for a joint regulatory scheme was first reached in 2003, but this project was not able to proceed because new zealand was unable to pass enabling legislation. negotiations between the countries were also suspended in july 2007 [218] . the increased collaboration between europe and the us in the pharmaceutical domain is another interesting example of bilateral cooperation. though this cooperation does not follow an integration model, it is a well-developed bilateral initiative. it is a stepwise and structured program that is interesting as it provides a clear example of what such bilateral collaboration can achieve in a nonintegration process, and also outlines its limitations. it also provides examples of the measures and organization necessary to support such bilateral work. the european union (eu) and the united states of america (us), in addition to their collaboration within the scope of multilateral frameworks such as the international conference on harmonization of technical requirements for registration of pharmaceuticals for human use (ich), have also established strong regulatory and scientific bilateral cooperation in the pharmaceutical sector. this bilateral cooperation promotes public health, safer trade of products, and harmonization of regulations. over the years, the scope of this transatlantic collaboration has increased, and today represents a good example of what bilateral cooperation can achieve. this collaboration mainly involves the european commission (ec), the european medicines agency (ema) and the united states food and drug administration (us fda). however, it is important to note that the us fda also maintains an active relationship with national dras throughout europe. confidentiality arrangements with the us have been signed at the european level (ec and ema) and also at the national level with austria, belgium, denmark, france, germany, ireland, italy, the netherlands, sweden, and the united kingdom. this is particularly important for collaboration in the area of inspections. it also allows the us fda to exchange information on products not approved via the centralized procedure (this exchange is done through the relevant reference member states [rmss]). the leaders of the eu and the us agreed on a framework for advancing transatlantic economic integration and established the transatlantic economic council (tec) to oversee the efforts outlined in the framework, with the goal of accelerating progress and guiding work between eu-us summits. moreover, confidentiality agreements have been established to create a framework allowing the exchange of confidential information between the eu and the us fda as part of their regulatory and scientific processes. they include information on advanced drafts of legislation and regulatory guidance documents, as well as nonpublic information related to ensuring the quality, safety, and efficacy of medicinal products for human (and veterinary) use. an implementation plan has also been agreed upon between all parties to allow for a successful exchange of information and documents between the eu and the us fda in accordance with the terms of the confidentiality agreements. the objective of this implementation plan was to describe the processes by which each party will undertake information and document exchange as envisioned by the confidentiality agreements. also, to facilitate this transatlantic pharmaceutical cooperation, the us fda and the ema have established "liaison officials." these liaison officials remain employed by their home organizations, but their physical location in the partner agency is designed to facilitate collaboration. their role is to facilitate regulatory and scientific cooperation between the us fda and the ema, and to coordinate information exchange. they also increase awareness of interaction opportunities with the ema and the us fda, and potential new areas of common interest [219,220]. in 2003, the scope of this bilateral cooperation intensified with the establishment of confidentiality arrangements between the parties. these agreements signed on september 12, 2003 were then extended on september 15, 2005. in september 2010, these confidentiality agreements were extended again, and are now in effect for an indefinite period without the need for further renewal. these two 2010 official statements of authority and confidentiality commitment [223, 224] restate the agreement to pursue in-depth collaboration and exchange of confidential nonpublic information between the us fda and the ema. it is interesting to note that these statements reiterate that the shared information includes confidential commercial or trade secret information (the us fda is required by current legislation to ask pharmaceutical companies before sharing trade secret information with counterpart dras). at the eu-us summit on april 30, 2007, further momentum was given to regulatory collaboration with the signature of the framework for advancing transatlantic economic integration between the european union and the united states of america by ec president josé manuel barroso, german chancellor angela merkel, and us president george w. bush. this document called for more effective, systematic, and transparent regulatory cooperation, and the removal of unnecessary differences between regulations. it also specifically requested the promotion of "administrative simplification in the application of regulation of medicinal products." the objective of this bilateral process is more towards cooperation than harmonization per se. exchange of information between the parties allows for a better understanding of each other's systems and requirements, and therefore builds confidence and recognition facilitating convergence. this eu-us cooperation also tries to avoid future disharmony by upstream regulatory cooperation on new medicines legislation [225] . the exchange of information and practices are well structured and occur on a regular basis, but the exchange can also be done on an ad hoc basis if necessary. ▸ regular exchange: the ema and us fda exchange a list of specific information on applications (both pre-authorization of new molecules and post-authorization of marketing products), including decisions made for such applications on a quarterly basis. they also exchange other information such as a list of good clinical practice (gcp) inspections or pharmacovigilance topics (either product-or nonproduct-related issues). ▸ ad hoc exchange: in addition to the exchange of new drafts of final legislation or guidelines (prior to publication), the eu and us fda also exchange information relating to scientific advice, difficulties in relation to the evaluation of applications, and urgent drug safety issues and other issues impacting public health. these types of information are exchanged prior to their release into the public domain. meetings or workshops on regulatory issues of mutual concern are also organized on an ad hoc basis. finally, the ema and the us fda publish an annual report summarizing their interactions under the confidentiality arrangements. these arrangements also provide for annual meetings between the us fda, the ema, and the ec to monitor the operation of activities within the scope of the agreed-upon implementation plans. however, it should be noted that the sharing of product-related information is limited to medicinal products evaluated or authorized in accordance with the eu centralized procedure, as well as medicinal products authorized at the national level by the eu member states, which are subject to arbitration or referral in accordance with european community procedures [226]. initiatives related to general topics are reported below. in addition to these initiatives, cooperation has also been established in certain specific scientific areas or for a specific type of product (i.e., oncology, pharmacogenomics, nanotechnology, advanced therapy medicinal products [atmp], blood products, and vaccines). under the auspices of the transatlantic economic council, on november 28, 2007 the ec hosted the "transatlantic administrative simplification workshop" in brussels, belgium, which was co-chaired by the ec and the us fda and organized in collaboration with the ema and the heads of the eu national medicines agencies (hma). the key objective was to identify opportunities for administrative simplification through transatlantic cooperation in the removal of unnecessary burdens of administrative practices and guidelines. this would allow more human and fiscal resources to be focused on greater innovation and efficiency in the development of quality products. it was agreed that this project should not require change to legislation, and of course, the simplifications should maintain or increase current levels of public health protection. as a follow up to the transatlantic administrative simplification workshop, a "medicines regulation transatlantic administrative simplification action plan" was published in june 2008, outlining administrative simplification projects to be taken forward. this document promoted further cooperation and pilot collaboration programs in major areas such as inspections, biomarkers, counterfeit medicines, risk management (content and format), scientific advices, biosimilars, pediatrics, and advanced therapies. during the annual ec/ema-us fda bilateral meeting in september 2010, it was agreed that the majority of projects in the original plan had been successfully completed and that most of the pilot projects had been extended and became "standard" cooperation [227] . ongoing developments and new initiatives in transatlantic administrative simplification are now included in the annual reports on interactions between the us fda and the ema. several projects have been initiated to increase collaboration on gmp and gcp inspections. ad hoc exchanges on specific products, quality defects, product shortages, and on draft guidelines also took place. ▸ gmp inspections: several pilot projects were first initiated in the context of the transatlantic administrative simplification workshop deliverables. an initial project (established in cooperation with the european directorate for the quality of medicine and the australian therapeutic goods agency) was conducted between december 2008 and december 2010 and related to gmp inspections of active pharmaceutical ingredients (api) manufacturers [228] . the project's objective was to determine whether greater international collaboration and information sharing could help to better distribute inspection capacity, thus allowing more sites to be monitored and reducing unnecessary duplication. the second project, related to finished products, allowed eu-us fda joint inspections and was aimed at developing ways of working together on joint inspections of routinely scheduled sites in the territory of the us or eu, to reduce duplicate inspections and the resulting burden on both the pharmaceutical industry and the dras. this pilot phase, conducted under confidentiality agreements, allowed the development of new tools for work sharing and the exchange of information in order to share inspection reports and to organize joint inspections. increased transparency and visibility of inspections performed by participating authorities allowed a successful collaboration between authorities on manufacturing sites of common interest. it also increased the number of inspections performed that were of value to more than one authority. this pilot phase confirmed that such collaboration in the area of gmp inspections led to a reduction in duplicate inspections, more efficient use of combined inspectional resources, and wider global inspectional coverage. following the successful conclusion of the pilot, it was agreed to maintain the cooperation established [229] . in december 2011, the us fda and the ema decided to further enhance their gmp inspection cooperation by moving from confidence building to reliance upon [230] . this initiative, launched in january 2012, allows the ema and the us fda to share inspections of manufacturing sites in each other's territories. this important step follows the positive experience acquired through the pilot joint inspection programs and other information sharing projects that have occurred over several years. this strategy allows some inspections on each other's territories to be deferred or waived completely based on a number of considerations and on a risk-based approach [231] . this strategy is applicable to gmp inspections related to manufacturing sites located in the us and the european economic area (eea), mainly focusing on routine post-authorization and surveillance inspections as a first step [232] . the result of this arrangement could free up inspection resources that would then become available for inspections to other regions. ongoing ema-us fda joint inspection pilot projects will continue according to the agreedupon procedures [233, 234] as it remains important to maintain mutual confidence and build further mutual understanding of gmp inspection approaches. some successful pilot programs will also be expanded to new partners such as the ongoing collaboration on gmp inspections of active substance manufacturers [235] . due to the increased globalization of pharmaceutical product clinical development, and based on previous positive experiences in the gmp field, the ema and us fda agreed to launch a pilot ema-us fda gcp initiative. the objective of this gcp initiative, conducted between september 2009 and march 2011, was to reinforce and systematize periodic information exchanges on gcp-related activities between the us fda and ema. these included the exchange of gcp inspection plans to improve inspection coverage, the exchange of information on applications to help identify candidates for collaborative inspections, and the exchange of inspection outcomes and reports (both negative and positive) and their potential impact. conduct of collaborative gcp inspections and the sharing of information on interpretation of gcp (such as draft guidelines or policies) were also part of this project. the pilot initiative has been very productive. a considerable amount of information has been exchanged on many products [236] , and this communication (which included 23 teleconferences and four face-to-face meetings) has facilitated improvements in the inspection coverage and decision-making processes of the agencies. the 13 collaborative inspections conducted under the initiative have contributed greatly to each agency's understanding of the other's inspection procedures. they have also led to the identification of potential improvements to these procedures. both agencies have learned several general lessons during the process [237]. in addition, exchanges of views on interpretation of gcp documents have also been organized. during the pilot initiative, the ema and the us fda have shared different pieces of gcp-related guidance documents, position papers, and policies in order to harmonize the agencies' understanding of gcp and to standardize the requirements for industry wherever convergence would be beneficial for the clinical research process. at the end of the program, both parties considered this pilot initiative very successful and agreed to continue this collaboration, incorporating lessons learned with the broader aim of moving from "confidence building" to the mutual acceptance of inspectional findings. the agencies will also expand the scope of the initiative to sites outside the us and eu [238]. although not defined as a cluster, interactions in the area of safety continue to play an important part in the ongoing collaboration between the us fda and the ema. ▸ videoconferences take place on a bimonthly basis and include product-related issues and issues related to risk management. usually five to six products are discussed at these teleconferences. ▸ regular informal teleconferences in order to exchange information on emerging safety and strategic issues. ▸ ema shares the early notification system on a monthly basis and the us fda sends advance notice of publication of its quarterly update reports on potential safety signals. ▸ joint projects have also been established, such as the collaborative project on the progressive multifocal leukoencephalopathy research agenda to stimulate research into this important safety issue that affects some biological agents. the objective of this program is to allow interaction between the ema and the us fda assessors and sponsors during product development. this dialogue between the two agencies' assessors and sponsors on scientific issues [240] aims to optimize product development and avoid both unnecessary testing replication and unnecessary diverse testing methodologies. such a procedure can be valuable for products developed for indications for which development guidelines do not exist, or if guidelines do exist, the ema's and the us fda's recommendations differ significantly. experts from the ema and the us fda exchange views and discuss draft responses to questions from the applicants on their clinical development programs or on new biomarkers. general principles for this voluntary parallel scientific advice were published in 2009 by the ema and the us fda [241] . it is important to understand that this is a parallel procedure, and unfortunately, not joint advice. the goals of the ema and us fda are primarily to share information and perspectives, rather than specific harmonization of study or regulatory requirements (although they recognize that harmonization is a beneficial outcome). after this procedure, the two agencies conduct their individual regulatory decision-making process regarding drug development issues and marketing applications. each agency provides independent advice to the sponsor regarding questions posed according to their own usual procedures and timelines. the advice of each agency may therefore still differ after the joint discussion. however, in many cases, these discussions between regulators achieved a high degree of alignment and helped industry move closer to a global development plan [242] . in 2010, following a rather slow acceptance in previous years (due to hesitation from industries to use this procedure that does not commit the two agencies to issue common advice), the ema and the us fda discussed seven new parallel scientific advice procedures. who experts were involved in two of these procedures, due to the therapeutic area covered by the request. in addition to the formal parallel scientific advice exchanges between the us fda and the ema, ad hoc informal scientific advice teleconferences between the agencies took place for five products in 2010 [243]. "clusters" or specific areas of mutual interest have been identified, and a more structured working relationship has been established. these clusters (i.e., oncology, pediatrics, orphan medicines, pharmacogenomics, blood products, biosimilars, and vaccines) facilitate the exchange of information through teleconferences relating to applications for marketing authorization and extensions of indications, including risk management plans [244] . the latest cluster established, with a focus on biosimilars [245], significantly increased cooperation between the agencies. the recent announcement from the ema stating that the agency will now accept data from reference product batches sourced outside the eu for biosimilar product applications [246] will certainly boost the eu-us cooperation in this domain and the global development of biosimilar products. this decision follows the us fda proposal to also accept comparative data referencing a product that is not approved in the us [247]. the eu-us fda collaboration on orphan drug development has been important. discussions between the ema and the us fda usually include sharing of information on applications submitted in order to approach and discuss criteria for designation. a common application form has been designed and agreed to so that sponsors can apply for orphan designation (of the same medicinal product for the same use) in both jurisdictions using this common form, facilitating the exchange of information. since 2010, discussions have also included analysis of different opinions. on february 26, 2010, the us fda and the ema announced that they had agreed to accept the submission of a single annual report mmm from sponsors of orphan products designated for both the us and the eu [248] . each regulatory body continues to conduct their own review of the annual report to assure the information meets their own requirements. the use of one single report benefits both the sponsor and the two regulatory agencies. the sponsors benefit from the elimination of duplication of efforts to develop two separate reports, and the regulators can better identify and share information throughout the development process of an orphan product. collaboration in pediatrics is governed by the principles agreed to in 2007 [249] . this framework includes information exchange (product-specific and general issues) and invitation of the other party to relevant pediatrics meetings. the two main objectives are (1) to avoid exposing mmm these reports provide information on the status of the development of orphan medical products, including a review and status of ongoing clinical studies, a description of the investigation plan for the coming year, any anticipated or current problems in the process, difficulties in testing, and any potential changes that may impact the product's designation as an orphan product. children to unnecessary trials, and (2) to facilitate the development of global pediatric development plans that are based on scientific grounds and that are compatible for both agencies. in practice, the cluster on pediatrics organizes monthly teleconferences between the ema's pediatric team and the us fda during which pediatric investigational plans (pips) are discussed in detail and information between the two agencies is exchanged. in addition, more general questions have also been addressed, such as extrapolation, choice of endpoints, and patient/parent reported outcomes. from september 2009 until september 2010, 42 products and four general topics were discussed [250] . since the end of 2009, us fda representatives have been able to participate in certain ema pdco discussions and vice versa. the ema has also provided the us fda access to its internal database that includes scientific details on all pips. several guidelines have been developed at the ich level (ich q8, q9, q10) in order to facilitate the implementation of "quality by design." taking into account the global perspective of pharmaceutical manufacturing, the ema and us fda agreed that it would be beneficial if at this early stage of implementation assessors from the us and eu could exchange their views on the implementation of ich concepts and relevant regulatory requirements using actual applications. a three-year pilot program, operating under the us-eu confidentiality arrangements, started in april 2011. this program allowed parallel evaluation of "quality by design" aspects of applications submitted to the ema and the us fda at the same time [251-1]. on august 20, 2013, the ema and us fda published the lessons learned and q&a resulting from the first parallel assessment. both agencies found the pilot program extremely useful to share knowledge, facilitate a consistent implementation of the ich guidelines, and harmonize regulatory decisions to the greatest extent possible [251-2]. the bilateral collaboration between the eu and the us has been extremely productive, and today it is recognized as a very successful initiative. its scope has increased over the years, from the basic exchange of information and harmonization of format to close collaboration and discussion of divergent positions. the liaison placement in each organization has also been an important decision to facilitate such cooperation. this increase in interaction, in a relatively short period of time, has been driven in part by reaction to crises and in part by proactive measures to enhance ema-us fda communication and collaboration [252] . the establishment of the transatlantic administrative simplification project in 2007 has also been beneficial as it initiated several pilot projects that further demonstrated the need for, and benefits of, such collaboration. in general, activities in all the clusters have increased over time, and there has been an overall increase in the number of ad hoc requests for teleconferences on specific products and topics. following a significant increase between 2008 and 2009, the total number of monthly us fda and ema interactions (i.e., teleconferences, document exchanges, etc.) now averages about 55 per month, excluding document exchanges relating to cluster and pilot activities. significant achievements have also been made in several critical areas for public health such as orphan medicinal products (with the agreement on a single annual report), drug development (with the establishment of the parallel scientific advice procedure and collaboration on pediatric development), gcp and gmp inspections (with several successful pilot projects that increased collaboration), and safety of products (with close collaboration and regular exchange of safety information, risk management, and safety alerts). exchange of draft regulation (before release in the public domain) has also facilitated harmonization of practices and exchange of opinions. finally, tools for more effective tracking have also been developed. all these achievements confirm that collaborations between countries have a positive impact on public health. it is particularly evident in certain areas such as orphan drug development (for diseases affecting a small population) or the exchange of information relating to urgent drug safety issues (to better assess and understand risks). it is also important to note that this successful collaboration allows not only for the convergence of practices, but more importantly, this exchange of information and communication builds confidence in each other's systems, practices, and evaluations, allowing for a sharing of activities in certain areas. this is already the case in the area of inspection. in december 2011, ema spokesperson monika benstetter stated that "each agency is now relying on its partner for drug manufacturing facility inspection data." [253] the success of this transatlantic cooperation is partly due to the fact that it has been well structured and organized over the years. the establishment of clusters and then the creation of the liaison officials' positions nnn strengthen regulatory cooperation between the agencies. these decisions have been extremely beneficial from the perspective of education and timely communication. a large number of staff visits and exchanges also took place, and there is now more routine involvement in the scientific work of both agencies. the us fda representatives take part as observers in committee for medicinal products for human use (chmp) discussions, and the ema representatives are provided with access to webcasts of us fda advisory committees. however, other parameters such as those listed below have also been critical for this success, and clearly demonstrate their importance of this type of cooperation and harmonization initiative: ▸ first, it is clear that the political commitment to increased cooperation has been important. indeed, closer collaboration was evident after the signing of the "framework for advancing transatlantic economic integration between the european union and the united states of america" in 2007 by ec president josé manuel barroso, german chancellor angela merkel, and us president george w. bush. ▸ second, the establishment of confidentiality agreements, which since 2010 are effective for an indefinite period, allow both parties to exchange inspection reports or other nonpublic product-related information. this was critical in the establishment of collaboration as this communication on specific practical cases allowed the parties to nnn since 2009, the fda has seconded a permanent representative to the ema's office in london. since early 2010, the ema has seconded a representative to the fda's offices. discuss the similarities and differences of opinion when assessing product applications and documentation. although necessary, sharing only public information (i.e., new regulations and guidelines) does not provide this opportunity. ▸ third, this bilateral collaboration benefited from the fact that both parties had the same level of maturity and development of their systems and regulations, and similar public health needs and challenges (even if they were not always identical). ▸ lastly, the step-by-step approach established has been helpful because it provided clear priorities (with the clusters), allowed progressive exchange of information (from ad hoc requests to regular teleconference and nonpublic product information exchange), and time for each party to evaluate the partner agency's system and practices (with several specific pilot projects and visits/exchange of staff). although it took some time and a lot of effort, these different steps were beneficial as they facilitated transparency and confidence building. this clear understanding of similarities and differences of practices is a prerequisite to foster a culture of convergence of each agency's assessments and evaluations. to conclude, this bilateral collaboration is now very developed and has moved from confidence building and exchange of information, to recognition of each other's information and data for decision making. its success so far supports the continuation of this collaboration and even its extension, as confidence in each other's system continues to increase. although it is recognized that each party will remain ultimately responsible for public health in their territories, closer cooperation and convergence are obviously possible in many domains. finally, it would be beneficial to continue to expand successful projects to additional partners (as has been the case for gmp inspections of active substance manufacturers [254] ) in order to foster greater international collaboration and information sharing. in addition to the bilateral, regional, and global regulatory initiatives described in previous sections, other technical and scientific harmonization projects have also been initiated. although these projects do not enter in the scope of this research (as they do not specifically relate to regulatory harmonization), it is important to mention them, as the standards they develop are often used by the regulatory harmonization initiatives. the following organizations and projects ooo have indeed supported the harmonization of standards in the pharmaceutical domain: ▸ the pharmacopoeial discussion group (pdg) involves (since 1989) the european pharmacopoeia (ep), the japanese pharmacopoeia (jp), and the us pharmacopeia (usp) to harmonize pharmacopoeial standards (i.e., excipient monographs and selected general chapters). it works in collaboration with ich, and who became an observer in may 2001. ooo this list of organizations/projects below is provided as an example and does not represent an exhaustive list. ▸ the international organization for standardization (iso) is the world's largest developer and publisher of international standards (with a network of the national standards institutes of 163 countries and a central secretariat in geneva, switzerland). this is a nongovernmental organization that today has more than 19,000 international standards and other types of normative documents covering many technical areas. ▸ the pharmaceutical inspection co-operation scheme (pic/s) facilitates (since 1995) ppp cooperation and networking in the field of good manufacturing practice (gmp) in order to lead the international development, implementation, and maintenance of harmonized gmp standards and quality systems of inspectorates in the field of medicinal products. the pic/s activities include the development and promotion of harmonized gmp standards and guidance documents, the training of inspectors, and the assessment of inspectorates. this initiative currently includes more than 40 worldwide pharmaceutical inspection authorities. ▸ the council for international organizations of medical sciences (cioms) is an international, nongovernmental, nonprofit organization that was established jointly by who and the united nations educational, scientific and cultural organization (unesco) in 1949. it includes over 55 international, national, and associate member organizations representing many of the biomedical disciplines, national academies of sciences, and medical research councils. one of the objectives of cioms is to facilitate and promote international activities in the field of biomedical sciences, and its activities include programs on drug development and international nomenclature of diseases. ▸ the world medical association (wma) is an international organization founded in 1947 to represent physicians. today, it includes 100 national medical associations, and its goal is to achieve consensus on the highest international standards of medical ethics and professional competence. the declaration of helsinki (developed in 1964) is the wma's best-known policy statement. finally, other groups of experts have also worked and released recommendations on specific topics related to the harmonization of pharmaceutical regulations (e.g., the phrma's [pharmaceutical research and manufacturers of america] simultaneous global development project [255] or the nonprofit transcelerate biopharma project [256] ). all these projects contribute to the global convergence and harmonization of pharmaceutical regulations. many harmonization initiatives have been established over the past several decades because regulators understand that cooperation can help in resolving the new challenges brought on by globalization. understanding the importance and advantages of cooperation and ppp the pharmaceutical inspection convention (pic) had been operating since 1970. harmonization in supporting their mandate to promote and protect public health, many countries and regions have strongly enhanced their collaboration with other countries bilaterally and multilaterally at the regional and global levels. the globalization of the pharmaceutical market has highlighted several problems that have been associated with data generated from foreign countries and with imported products. for example, in 2008, deaths associated with heparin imported from china into the us was due to contamination of its pharmaceutical ingredients at a chinese plant, and in panama, the diethylene glycol found in cold and fever medicine killed many people [257] [258] [259] . these problems have been a wake-up call, and they further increased the recognition of benefits to be derived from leveraging the activities and resources of foreign counterpart dras [260] . for example, the us has strongly increased their international collaboration in the pharmaceutical domain. us legislators decided that such international cooperation and harmonization activities are an integral part of the us fda's mission. indeed, the food and drug administration modernization act of 1997 stated that one of the missions of the fda is to "participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements" [261] . since then, the us fda's international work has grown exponentially, especially over the past decade, to respond and adapt to the new global society [262] . it has increased communication qqq and developed regulatory cooperation with other countries (bilaterally and multilaterally). the us fda's role in harmonization and multilateral relations is to coordinate and collaborate on activities with various international organizations (i.e., who, ich, pandrh, and apec) and individual countries on international standards and harmonization of regulatory requirements. in pursuit of appropriate international collaboration, the us fda utilizes a wide variety of international arrangements, including "confidentiality commitments" rrr and "memoranda of understanding and other cooperative arrangements." sss the ema is one of the us fda's closest regulatory partners. with china, uuu the us fda must increase its capacity for inspecting and analyzing chinese products before they are shipped to the us. in order to accomplish this, the us fda established an office in beijing, china in november 2008 and employed 14 people (with additional employee hiring planned in the following years [263] ). it has allowed for solid relationships with chinese regulators and exporters, and has trained more than 1,600 manufacturers and regulators on us safety standards in two years [264] . finally, there has been increasing recognition within the us fda of the need to strengthen regulatory capacity and provide technical and scientific expertise to developing countries to ensure that products exported to the us meet us fda standards and adequate levels of patient protection. many cooperative initiatives have been established to meet this goal [265] . other countries and regions, including the us, eu, australia, canada, singapore, and china. these bilateral collaborations are based on confidential agreements vvv and include information sharing. proactive exchange of staff has also been agreed upon with some dras ( ). japan's pmda has also developed privileged relationships with china and south korea following the pandemic influenza crisis [271, 272] . since 2007, this tripartite initiative has specifically cooperated on clinical research and promoted regional clinical trials [273, 274] . in february 2009, the advisory council approved the pmda international strategic plan as a framework for its international activities [275] . this plan outlined the strategies for bilateral, regional, and global cooperation, and established an internal office in charge of international affairs. in line with this international strategic plan, further goals (to be attained by 2020) were published in november 2011 . finally, a roadmap for the pmda international vision was released in april 2013. in this roadmap, the pmda defines more specific actions to support its international vision . the primary objective of this increase in international collaboration was to urgently resolve the "drug lag" www that has impacted the japanese pharmaceutical market in the past (2.4 years in 2006). many measures have been taken to improve the clinical testing environment (including the promotion of global clinical trials) and expedite drug approval decisions (via, among other measures, the increase of collaboration with the other worldwide dras). a global, simultaneous drug development approach has also been strongly recommended. many actions, including release of guidelines, have been taken to facilitate such global development [277] . in addition to the us and japan, other major dras of developed countries (such as health canada and the australian tga) also recognized the important added value of global cooperation and therefore increased their involvement in international activities. the eu, based on its prior experience of harmonization and cooperation from the establishment of its own system, has also developed external bilateral and multilateral collaborations and is today an important international partner. although these diverse, coexisting, bilateral, regional, and global initiatives create complexity, it is important to note that they are complementary. global harmonization does not preclude having regional harmonization and regional harmonization does not preclude bilateral agreements. in fact these three levels of harmonization and cooperation bring about different added value: ▸ bilateral agreements allow for a bigger exchange of information, including productspecific data, through confidential agreements and the development of privileged relationships (and trust) between regulators as they allow for assessment of one another's vvv in the case of china, a cooperative agreement has been established. www drug lag is defined as the difference of availability of new medicines between the us and japan. systems and practices. xxx these assessments are indeed critical for confidence building and can ultimately support the signing of agreements, allowing for recognition of inspection or the exchange of nonpublic information (e.g., eu/us collaboration and confidentiality agreements). bilateral collaboration also helps strengthen relationships, which would be more difficult in the context of a multilateral initiative, and facilitates training and mentoring activities between developed and developing countries. ▸ regional harmonization allows for the harmonization of policies between countries that are usually closer in term of systems, cultures, and levels of development. it is indeed easier to harmonize closed systems and policies between countries of similar culture and environment (for example, it is more difficult to harmonize systems and policies between asia and north america because they have very different medical practices and cultures). this level is essential for global harmonization because it provides a structure. achieving global harmonization without a supporting regional organization structure is impossible. this regional level allows for inclusion of regional realities and difficulties in global discussions, and eases the diffusion and implementation of the global recommendations. ▸ global harmonization is the highest level of harmonization. compared to regional harmonization, the global harmonization initiative is not driven by economic objectives; the goal is not to create a free trade area or a single market, but to develop global consensus and standards in order to allow the world's population to have access to medicine and innovative therapies. to conclude, these bilateral, regional, and global cooperative activities have been beneficial as they supported the harmonization of requirements globally and therefore facilitated the availability of safe and efficacious medicines, critical in promoting global public health, on a worldwide basis. many topics and standards have already been partly or fully harmonized at a bilateral, regional, or global level. for example, most of the requirements regarding the conduct of nonclinical studies, and also the gmp and good clinical practice (gcp) principles, have been agreed on, allowing for joint inspection projects. a common format of application has been developed, and many technical aspects have been harmonized through the ich's work. collaboration has also been increasing in resolving major topics requiring global interaction, such as orphan drug evaluation yyy and development of medicines for the pediatric population. zzz confidence and trust have been built between developed countries through pilot projects, but xxx for example, bilateral collaboration allows two countries to assess their respective inspection systems or systems to control critical information (such as trade secrets). such assessments of each other systems could be possible in the case of multilateral collaboration, but would be more complex. yyy because only a small number of the population is affected by these life-threatening diseases or serious conditions, it is critical to have global requirements in order to facilitate global clinical studies. moreover, the pharmaceutical industry has been reluctant to invest in the research and development of medicinal products to treat these conditions. the development of global requirements allows quick access to the global market and therefore allows a better return on investment. zzz it is critical that countries cooperate in this area to avoid exposing children to unnecessary trials. also through the location of official liaisons in other dras to facilitate collaboration. this has been positive, and this new type of interaction is very promising as it increases relationships and allows for the better exchange of experiences and information. aaaa the establishment of liaisons in other countries also allows more proactive measures and risk analysis in the area of quality systems and inspections [278] . exchanges of information between dras have also dramatically increased. this regular communication between regulators facilitates evaluation of risk (e.g., via exchange of safety alerts) and assessment of new medicines. finally, systems have been put in place to help developing countries (e.g., cpp scheme, prequalification of medicines, article 58 of european regulation (ec) no 726/2004, etc.). however, without underestimating all these important positive outcomes, it is clear that differences still exist and that further efforts will be required to support this ongoing harmonization process. there are still differences between countries in terms of standards and strategies to assess compliance against standards. the conduct of global clinical studies continues to present many challenges (i.e., related to registration, conduct of the studies, and also the use of data), and there are still several clinical trial registries and databases in use. the safety of medicines has been one of the main focuses of dras in the past due to major problems and events, but there has not been a real effort toward worldwide harmonization regarding risk-mitigation strategies. additionally, new standards continue to be developed by different bodies (i.e., ich vs. regional organizations) in parallel that not only duplicate efforts, but also create disharmony (e.g., biosimilars requirements had first been developed by individual countries and also by who). there is also a significant difference in the level of implementation of harmonized standards (i.e., the ich recommendations/guidelines) between countries, and the ctd format has still not been implemented in all countries. it has also been reported that differences between developed and developing countries has in fact continued to increase in the past several years due to the increased complexity of technologies associated with the development of new therapies. even between two close partners like the us and eu, which have developed a privileged partnership and strong cooperation, there are still important differences in standards. for example, the us is still requiring two placebo-controlled studies to determine efficacy of a new medicine, while the eu is more interested in comparative studies using an active comparator. this difference is due to different legal requirements and scientific opinions regarding the value of such comparative data [279] . this situation may change in the future with the growing interest in the us for "comparative effectiveness" promoted by the obama administration. finally, this complex worldwide harmonization context (with increased communication and exchange of experience, information, and good practices) requires good communication and coordination between all these ongoing initiatives. even if such communication was initiated by who and ich (with the gcg group), further improvement would still be needed. this enhanced coordination of international cooperation would indeed be beneficial, as it would provide the necessary transparency regarding the focus and responsibility of each initiative (i.e., development of standards, coordination of implementation of recommendations, etc.). aaaa exchange of information and best practices has been one of the most important outcomes of the eu/us bilateral collaboration. it would also facilitate the appropriate use of resources and expertise, and therefore avoid duplication of efforts or conflicting recommendations and actions. overlapping membership between the initiatives bbbb may not be fully efficient, and can create confusion and duplication of work. although the increased coordination of these diverse initiatives would be beneficial, it will certainly be challenging. it will need to be thoroughly structured and implemented, and it will also be critical that the coordinated body is a recognized and experienced entity, with appropriate mandate and power. under this directorate, the us fda's office of international programs serves as the agency's focal point for all international matters and is responsible for maximizing the impact of the us fda's global interactions. additional us fda reorganizations were also announced in 2012 to further respond to drug industry globalization [268]. also, in addition to china, the us fda now has staff stationed permanently in india the total number of shipments of us fda-regulated products from china increased from approximately 1.3 million to 2.1 million. of the 2.1 million entry lines arriving in 2011, 30% were drugs and devices, and 12% were human food products key: cord-002774-tpqsjjet authors: nan title: section ii: poster sessions date: 2017-12-01 journal: j urban health doi: 10.1093/jurban/jti137 sha: doc_id: 2774 cord_uid: tpqsjjet nan food and nutrition programs in large urban areas have not traditionally followed a systems approach towards mitigating food related health issues, and instead have relied upon specific issue interventions char deal with downstream indicators of illness and disease. in june of 2004, the san francisco food alliance, a group of city agencies, community based organizations and residents, initiated a collahorarive indicator project called rhe san francisco food and agriculture assessment. in order to attend to root causes of food related illnesses and diseases, the purpose of the assessment is to provide a holistic, systemic view of san francisco\'s food system with a focus on three main areas that have a profound affect on urban public health: food assistance, urban agriculture, and food retailing. using participatory, consensus methods, the san francisco food alliance jointly developed a sec of indicators to assess the state of the local food system and co set benchmarks for future analysis. members collected data from various city and stare departments as well as community based organizations. through the use of geographic information systems software, a series of maps were created to illustrate the assets and limitations within the food system in different neighborhoods and throughout the city as a whole. this participatory assessment process illustrates how to more effectively attend to structural food systems issues in large urban areas by ( t) focusing on prevention rather than crisis management, (2) emphasizing collaboration to ensure institutional and structural changes, and (3) aptly translating data into meaningful community driven prevention activities. to ~xplore the strategies to overcome barriers to population sample, we examined the data from three rapid surveys conducted at los angeles county (lac). the surveys were community-based partic· 1patory surveys utilizing a modified two-stage cluster survey method. the field modifications of the method resulted in better design effect than conventional cluster sample survey (design effect dose to that if the survey was done as simple random sample survey of the same size). the surveys were con· ducte~ among parents of hispanic and african american children in lac. geographic area was selected and d1.v1ded int.o small c~usters. in the first stage, 30 clusters were selected with probability proportionate to estimated size of children from the census data. these clusters were enumerated to identify and develop a list of households with eligible children from where a random sample was withdrawn. data collectmn for consented respondents involved 10-15 minutes in-home interview and abstraction of infor· ma~ion from vaccine record card. the survey staff had implemented community outreach activities designed to fost~r an~ maintain community trust and cooperation. the successful strategies included: developing re.lat1on .w.1th local community organizations; recruitment of community personnel and pro· vide them with training to conduct the enumeration and interview; teaming the trained community introduction: though much research has been done on the health and social benefits of pet ownership for many groups, there have been no explorations of what pet ownership can mean to adults who are marginalized, living on fixed incomes or on the street in canada. we are a community group of researchers from downtown toronto. made up of front line staff and community members, we believe that community research is important so that our concerns, visions, views and values are presented by us. we also believe that research can and should lead to social change. method: using qualitative and exploratory methods, we have investigated how pet ownership enriched and challenged the lives of homeless and transitionally housed people. our research team photographed and conducted one-on-one interviews with 11 pet owners who have experienced home· lessncss and live on fixed incomes. we had community participation in the research through a partnership with the fred vicror centre camera club. many of the fred victor centre camera club members have experienced homelessness and being marginalized because of poverty. the members of the dub took the photos and assisted in developing the photos. they also participated in the presenta· tion of our project. results: we found that pet ownership brings important health and social benefits to our partici· pants. in one of the most poignant statements, one participant said that pet ownership " ... stops you from being invisible." another commented that "well, he taught me to slow down, cut down the heavy drugs .. " we also found that pet ownership brings challenges that can at times be difficult when one is liv· ing on a fixed income. we found that the most difficult thing for most of the pet owners was finding affordable vet care for their animals. conclusion: as a group, we decided that research should only be done if we try to make some cha.nges about what we have learned. we continue the project through exploring means of affecting social change--for example, ~eti.tions and informing others about the result of our project. we would like to present our ~mdmgs and experience with community-based participatory action resea.rch m an oral. presentarton at yo~r conference in october. our presentation will include com· mumty representation ~f. both front-hne staff and people with lived experience of marginalization and homdessness. if this is not accepted as an oral presentation, we are willing to present the project m poster format. introduction the concept of a healthy city was adopted by the world health organization some time ago and it includes strong support for local involvement in problem solving and implementation of solutions. while aimed at improving social, economic or environmental conditions in a given community, more significantly the process is considered to be a building block for poliq reform and larger scale 'hange, i.e. "acting locally while thinking globally." neighbourhood planning can he the entry point for citizens to hegin engaging with neighbours on issues of the greater common good. methods: this presentation will outline how two community driven projects have unfolded to address air pollution. the first was an uphill push to create bike lanes where car lanes previously existed and the second is an ongoing, multi-sectoral round table focused on pollution and planning. both dt•monstrate the importance of having support with the process and a health focus. borrowing from traditions of "technical aid"• and community development the health promoter /planner has incorporated a range of "determinants of health" into neighbourhood planning discussions. as in most urban conditions the physical environment is linked to a range of health stressors such as social isolation, crowding, noise, lack of open space /recreation, mobility and safety. however typical planning processes do not hring in a health perspective. health as a focus for neighbourhood planning is a powerful starti_ng point when discussing transportation planning or changing land-uses. by raising awareness on determmants of health, citizens can begin to better understand how to engage in a process and affect change. often local level politics are involved and citizens witness policy change in action. the environmental liaison committee and the dundas east hike lanes project resulted from local level initiatives aimed at finding solutions to air pollution -a priority identified hy the community. srchc supported the process with facilitation and technical aid. _the processs had tangible results that ultimately improve living conditions and health. •tn the united kmgdom plannm in the 60's established "technical aid" offices much like our present day legal aid system to provide professional support and advocacy for communities undergoing change. p2-15 (c) integrating community based research: the experience of street health, a community service agency i.aura cowan and jacqueline wood street health began offering services to homeless men and women in east downtown ~oronto in 1986. nursing stations at drop-in centres and shelters were fo~lowed by hiv/aids prevent10~, harm reduction and mental health outreach, hepatitis c support, sleeping bag exchange, and personal tdennfication replacement and storage programs. as street health's progi;ams expanded, so to~ did the agency:s recognition that more nee~ed t~ be done to. address the underl~ing causes of, th~ soct~l and economic exclusion experienced by its clients. knowing t.h~t. a~voca~y ts. helped by . evtd~nce , street he.alt~ embarked on a community-based research (cbr) initiative to 1dent1fy commumty-dnven research priorities within the homeless and underhoused population. methods: five focus groups were conducted with 46 homeless people, asking participants to identify positive and negative forces in their lives, and which topics were important to take action on and learn more about. findings were validated through a validation meeting with participants. results: participants identified several important positive and negative forces in their lives. key positive forces included caring and respectful service delivery, hopefulness and peer networks. key negative forces included lack of access to adequate housing and income security, poor service delivery and negative perceptions of homeless people. five topics for future research emerged from the process, focusing on funding to address homelessness and housing; use of community services for homeless people; the daily survival needs of homeless people and barriers to transitioning out of homelessness; new approaches to service delivery that foster empowerment; and policy makers' understanding of poverty and homelessness. conclusions: although participants expressed numerous issues and provided much valuable insight, definitive research ideas and action areas were not clearly identified by participants. however, engagement in a cbr process led to some important lessons and benefits for street health. we learned that the community involvement of homeless people and front-line staff is critical to ensuring relevance and validity for a research project; that existing strong relationships with community parmers are essential to the successful implementation of a project involving marginalized groups; and that an action approach focusing on positive change can make research relevant to directly affected people and community agency staff. street health benefited from using a cbr approach, as the research process facilitated capacity building among staff and within the organization as a whole. p2-16 (c) a collaborative process to achieve access to primary health care for black women and women of colour: a model of community based participartory research notisha massaquoi, charmaine williams, amoaba gooden, and tulika agerwal in the current healthcare environment, a significant number of black women and women of color face barriers to accessing effective, high quality services. research has identified several issues that contribute to decreased access to primary health care for this population however racism has emerged as an overarching determinant of health and healthcare access. this is further amplified by simultaneous membership in multiple groups that experience discrimination and barriers to healthcare for example those affected by sexism, homelessness, poverty, homophobia and heterosexism, disability and hiv infection. the collaborative process to achieve access to primary health care for black women and women of colour project was developed with the university of toronto faculty of social work and five community partners using a collaborative methodology to address a pressing need within the community ro increase access to primary health care for black women and women of colour. women's health in women's hands community health centre, sistering, parkdale community health centre, rexdale community health centre and planed parenthood of toronto developed this community-based participatory-action research project to collaboratively barriers affecting these women, and to develop a model of care that will increase their access to health services. this framework was developed using a process which ensured that community members from the target population and service providers working in multiculrural clinical settings, were a part of the research process. they were given the opportunity to shape the course of action, from the design of the project to the evaluation and dissemination phase. empowerment is a goal of the participatory action process, therefore, the research process has deliberately prioritized _ro enabling women to increase control over their health and well-being. in this session, the presenters will explore community-based participatory research and how such a model can be useful for understanding and contextualizing the experiences of black women and women of colour. they will address. the development and use of community parmerships, design and implementation of the research prorect, challenges encountered, lessons learnt and action outcomes. they will examine how the results from a collaborative community-based research project can be used as an action strategy to poster sessions v61 address che social determinants of women health. finally the session will provide tools for service providers and researchers to explore ways to increase partnerships and to integrate strategies to meet the needs of che target population who face multiple barriers to accessing services. lynn scruby and rachel rapaport beck the purpose of this project was ro bring traditionally disenfranchised winnipeg and surrounding area women into decision-making roles. the researchers have built upon the relationships and information gachered from a pilot project and enhanced the role of input from participants on their policy prioriries. the project is guided by an advisory committee consisting of program providers and community representatives, as well as the researchers. participants included program users at four family resource cencres, two in winnipeg and two located rurally, where they participated in focus groups. the participants answered a series of questions relating to their contact with government services and then provided inpuc as to their perceptions for needed changes within government policy. following data analysis, the researchers will return to the four centres to share the information and continue che discussion on methods for advocating for change. recommendations for program planning and policy development and implementation will be discussed and have relevance to all participants in the research program. women's health vera lefranc, louise hara, denise darrell, sonya boyce, and colleen reid women's experiences with paid and unpaid work, and with the formal and informal economies, have shifted over the last 20 years. in british columbia, women's employability is affected by government legislation, federal and provincial policy changes, and local practices. two years ago we formed the coalition ior women's economic advancement to explore ways of dealing with women's worsening economic situations. since the formation of the coalition we have discussed the need for research into women's employabilicy and how women were coping and surviving. we also identified how the need to document the nature of women's employability and reliance on the informal economy bore significanc mechodological and ethical challenges. inherent in our approach is a social model of women's health that recognizes health as containing social, economic, and environmental determinants. we aim to examine the social contexc of women's healch by exploring and legitimizing women's own experiences, challenging medical dominance in understandings of health, and explaining women's health in terms of their subordination and marginalizacion. through using a feminist action research (far) methodology we will explore the relationship between women's employability and health in 4 communities that represent bricish columbia's social, economic, cultural/ethnic, and geographic diversities: skidegate, fort st . .john, lumhy, and surrey. over the course of our 2 year project, in each community we will establish and work with advisory committees, hire and train local researchers, conduct far (including a range of qualitative methods), and support action and advocacy. since the selected communities are diverse, the ways that the research unfolds will 1·ary between communities. expected outcomes, such as the provision of a written report and resources, the establishment of a website for networking among the communities, and a video do.:umentary, are aimed at supporting the research participants, coalition members, and advisory conuniuces in their action efforts. p2t 9 (c) health & housing: assessing the impact of transitional housing for people living with hiv i aids currently, there is a dearth of available literature which examines supporrive housing for phas in the canadian context. using qualitative, one-on-one interviews we investigace the impact of transitional housing for phaswho have lived in the up to nine month long hastings program. our post<'r pr<·senta-t1on will highlight research findings, as well as an examination of transitional housing and th<· imp;kt it has on the everyday lives of phas in canada. this research is one of two ground breaking undertakings within the province of ontario in which fife house is involved. p2-20 (c) eating our way to justice: widening grassroots approaches to food security, the stop community food centre as a working model charles l.evkoe food hanks in north america have come co play a central role as the widespread response to growing rates of hunger. originally thought to be a short term-solution, over the last 25 years, they have v62 poster sessions be · · · 1· d wi'thi'n society by filling the gaps in the social safety net while relieving govemcome mst1tut1ona 1ze . . . t f the ir responsibilities. dependent on corporate donations and sngmauzmg to users, food banks men so th' . ·11 i i . are incapable of addressing the structural cause~ of ~u~ger. 1s pres~ntation w1 e~~ ore a ternanve approaches to addressing urban food security while bmldmg more sustamabl.e c~mmumt1es. i:nrough the f t h st p community food centre, a toronto-based grassroots orgamzanon, a model is presented case 0 e 0 h'l k' b 'id · b that both responds to the emergency food needs of communities w 1 e wor mg to. u1 ~ sustama le and just food system. termed, the community food centre model. (cfc), ~he s~op is worki?g to widen its approach to issues of food insecurity by combining respectful ~1rect service wit~ com~~mty ~evelop ment, social justice and environmental sustainability. through this approach, various critical discourses around hunger converge with different strategic and varied implications for a~ion. as a plac~-based organization, the stop is rooted within a geographical space and connected directly to a neighbourhood. through working to increase access to healthy food, it is active in maintaining people's dignity, building a strong and democratic community and educating for social change. connected to coalitions and alliances, the stop is also active in organizing across scales in connection with the global food justice movement. inner city shelter vicky stergiopoulos, carolyn dewa, katherine rouleau, shawn yoder, and lorne tugg introduction: in the city of toronto there are more than 32,000 hostel users each year, many with mental health and addiction issues. although shelters have responded in various ways to the health needs of their clients, evidence on the effectiveness of programs delivering mental health services to the home· less in canada has been scant. the objective of this community based research was to provide a forma· tive evaluation of a multi-agency collaborative care team providing comprehensive care for high needs clients at toronto's largest shelter for homeless men. methods: a logic model provided the framework for analysis. a chart review of 56 clients referred over a nine month period was completed. demographic data were collected, and process and outcome indicators were identified for which data was obtained and analyzed. the two main outcome measures were mental status and housing status 6 months after referral to the program. improvement or lack of improvement in mental status was established by chart review and team consensus. housing outcomes were determined by chart review and the hostel databases. results: of the clients referred 75% were single and 98% were unemployed. forty four percent had a psychiatric hospitalization within the previous two years. the prevalence of severe and persistent men· tal illness, alcohol and substance use disorders were 60%, 26% and 37% respectively. six months after referral to the program 37% of clients had improved mental status and 41 % were housed. logistic regression controlling for the number of general practitioner and psychiatrist visits, presence of person· ality or substance use disorder and treatment non adherence identified two variables significantly associ· ated mental status improvement: the number of psychiatric visits (or, 1.92; 95% ci, 1.29-2.84) and treatment non adherence (or, 0.086; 95% ci, 0.01-0.78). the same two variables were associated with housing outcomes. history of forensic involvement, the presence of a personality or substance use disorder and the number of visits with a family physician were not significantly associated with either outcome. conclusions: despite the limitations in sample sire and study design, this study can yield useful informa· tion to program planners. our results suggest that strategies to improve treatment adherence and access to mental health specialists can improve outcomes for this population. although within primary care teams the appropriate collaborative care model for this population remains to be established, access to psychiatric follow up, in addition to psychiatric assessment services, may be an important component of a successful program. mount sinai hospital (msh) has become one of the pre-eminent hospitals in the world by contributing to the development of innovative approaches to effective health care and disease prevention. recently, the hospital has dedicated resources towards the development of a strategy aimed at enhancing the hospital's integration with its community partners. this approach will better serve the hospital in the current health care environment where local health integration networks have been struck to enhance and support local capacity to plan, coordinate and integrate service delivery. msh has had early success with developing partnerships. these alliances have been linked to programs serving key target populations with _estabhshe~. points of access to msh. recognizing the need to build upon these achievements to remain compe~mve, the hospital has developed a community integration strategy. at the forefront of this strategy is c.a.r.e (community advisory reference engine): the hospital's compendium of poster sessions v63 community partners. as a single point of access to community partner information, c.a.r.e. is more than a database. c.a.r.e. serves as the foundation for community-focused forecasting and a vehicle for inter and intra-organizational knowledge transfer. information gleaned from the catalog of community parmers can be used to prepare strategic, long-term partnership plans aimed at ensuring that a comprehensive array of services can be provided to the hospital community. c.a.r.e. also houses a permanent record of the hospital's alliances. this prevents administrative duplication and facilitates the formation of new alliances that best serve both the patient and the hospital. c.a.r.e. is not a stand-alone tool and is most powerful when combined with other aspects of the hospital's community integration strategy. it iscxpected that data from the hospital's community advisory committees and performance measurement department will also be stored alongside stakeholder details. this information can then be used to drive discussions at senior management and the board, ensuring congruence between stakeholder, patient and hospital objectives. the patient stands to benefit from this strategy. the unique, distinct point of reference to a wide array of community services provides case managers and discharge planners with the information they need to connect patients with appropriate community services. creating these linkages enhances the patient's capacity to convalesce in their homes or places of residence and fosters long-term connections to neighborhood supports. these connections can be used to assist with identifying patients' ongoing health care needs and potentially prevent readmission to hospital. introduction: recruiting high-risk drug users and sex workers for hiv-prevention research has often been hampered by limited access to hard to reach, socially stigmatized individuals. our recruitment effom have deployed ethnographic methodology to identify and target risk pockets. in particular, ethnographers have modeled their research on a street-outreach model, walking around with hiv-prevention materials and engaging in informal and structured conversations with local residents, and service providers, as well as self-identified drug users and sex workers. while such a methodology identifies people who feel comfortable engaging with outreach workers, it risks missing key connections with those who occupy the margins of even this marginal culture. methods: ethnographers formed a women's laundry group at a laundromat that had a central role as community switchboard and had previously functioned as a party location for the target population. the new manager helped the ethnographers invite women at high risk for hiv back into the space, this time as customers. during weekly laundry sessions, women initiated discussions about hiv-prevention, sexual health, and eventually, the vaccine research for which the center would be recruiting women. ra.its: the benefits of the group included reintroducing women to a familiar locale, this time as customers rather than unwelcome intruders; creating a span of time (wash and dry) to discuss issues important to me women and to gather data for future recruitment efforts; creating a location to meet women encountered during more traditional outreach research; establishing the site as a place for potential retention efforts; and supporting a local business. women who participated in the group completed a necessary household task while learning information that they could then bring back to the community, empowering them to be experts on hiv-prevention and vaccine research. some of these women now assist recruitment efforts. the challenges included keeping the group women-only, especially after lunch was provided, keeping the membership of the group focused on women at risk for hiv, and keeping the women in the group while they did their laundry. conclusion: public health educators and researchers can benefit from identifying alternate congregation sites within risk pockets to provide a comfortable space to discuss hiv prevention issues with high-risk community members. in our presentation, we will describe the context necessary for similar research, document the method's pitfalls and successes, and argue that the laundry group constitutes an ethical, respectful, community-based method for recruitment in an hiv-prevention vaccine trial. p3-0t (c) upgrading inner city infrastructure and services for improved environmental hygiene and health: a case of mirzapur in u.p. india madhusree mazumdar in urgency for agricultural and industrial progress to promote economic d.evelopment follo_wing independence, the government of india had neglected health promotion and given less emphasis on infrastructure to promote public health for enhanced human pro uct1v_ity. ong wit r~p1 m astrucrure development, which has become essential if citie~ are to. act ~s harbmger.s of econ~nuc ~owth, especially after the adoption of the economic liberalization policy, importance _is a_lso ~emg g1ve.n to foster environmental hygiene for preventive healthcare. the world health orga~1sat10~ is also trj:'1!1g to help the government to build a lobby at the local level for the purpose by off~rmg to mrroduce_ its heal.thy city concept to improve public health conditions, so as to reduce th_e disease burden. this pape~ 1s a report of the efforts being made towards such a goal: the paper descr~bes ~ c~se study ?f ~ small city of india called mirzapur, located on the banks of the nver ganga, a ma1or lifeline of india, m the eastern part of the state of uttar pradesh, where action for improvement began by building better sanitation and environmental infrastructure as per the ganga action plan, but continued with an effort to promote pre· ventive healthcare for overall social development through community participation in and around the city. asthma physician visits in toronto, canada tara burra, rahim moineddin, mohammad agha, and richard glazier introduction: air pollution and socio-economic status are both known to be associated with asthma in concentrated urban settings but little is known about the relationship between these factors. this study investigates socio-economic variation in ambulatory physician consultations for asthma and assesses possible effect modification of socio-economic status on the association between physician visits and ambient air pollution levels for children aged 1 to 17 and adults aged 18 to 64 in toronto, canada between 1992 and 2001. methods: generalized additive models were used to estimate the adjusted relative risk of asthma physician visits associated with an interquartile range increase in sulphur dioxide, nitrogen dioxide, pm2.5, and ozone, respectively. results: a consistent socio-economic gradient in the number of physician visits was observed among children and adults and both sexes. positive associations between ambient concentrations of sul· phur dioxide, nitrogen dioxide and pm2.5 and physician visits were observed across age and sex strata, whereas the associations with ozone were negative. the relative risk estimates for the low socio-«onomic group were not significantly greater than those for the high socio-economic group. conclusions: these findings suggest that increased ambulatory physician visits represent another component of the public health impact of exposure to urban air pollution. further, these results did not identify an age, sex, or socio-economic subgroup in which the association between physician visits and air pollution was significantly stronger than in any other population subgroup. eco-life-center (ela) in albania supports a holistic approach to justice, recognizing the environ· mental justice, social justice and economic justice depend upon and support each other. low income cit· izens and minorities suffer disproportionately from environmental hazards in the workplace, at home, and in their communities. inadequate laws, lax enforcement of existing environmental regulations, and ~ea.k penalties for infractions undermine environmental protection. in the last decade, the environmental 1ust1ce m~ve~ent in tirana metropolis has provided a framework for identifying and exposing the links ~tween irrational development practices, disproportionate siting of toxic facilities, economic depres· s1on, and a diminished quality of life in low-income communities and communities of color. the envi· ~onmental justice agenda has always been rooted in economic, racial, and social justice. tirana and the issues su.rroun~ing brow~fields redevelopment are crucial points of advocacy and activism for creating ~ubstantia~ social chan~~ m low-income communities and communities of color. we engaging intensively m prevcnnng co'.'1mumnes, especially low income or minority communities, from being coerced by gov· ernmenta~ age_nc1es or companies into siting hazardous materials, or accepting environmentally hazard· ous_ practices m order to create jobs. although environmental regulations do now exist to address the environmental, health, and social impacts of undesirable land uses, these regulations are difficult to poster sessions v65 enforce because many of these sites have been toxic-ridden for many years and investigation and cleanup of these sites can be expensive. removing health risks must be the main priority of all brown fields action plans. environmental health hazards are disproportionately concentrated in low-income communities of color. policy requirements and enforcement mechanisms to safeguard environmental health should be strengthened for all brownfields projects located in these communities. if sites are potentially endangering the health of the community, all efforts should be made for site remediation to be carried out to the highest cleanup standards possible towards the removal of this risk. the assurance of the health of the community should take precedence over any other benefits, economic or otherwise, expected to result from brownfields redevelopment. it's important to require from companies to observe a "good neighbor" policy that includes on-site visitations by a community watchdog committee, and the appointment of a neighborhood environmentalist to their board of directors in accordance with the environmental principles. vancouver 1976-2001 michael buzzelli, jason su, and nhu le this is the second paper of research programme concerned with the geographical patterning of environmental and population health at the urban neighbourhood scale. based on the vancouver metropolitan region, the aim is to better understand the role of neighbourhoods as epidemiological spaces where environmental and social characteristics combine as health processes and outcomes at the community and individual levels. this paper builds a cohort of commensurate neighbourhoods across all six censuses periods from 1976 to 2001, assembles neighbourhood air pollution data (several criterion/health effects pollutants), and providing an analysis to demonstrate how air pollution systematically and consistently maps onto neighbourhood socioeconomic markers, in this case low education and lone-parent families. we conclude with a discussion of how the neighbourhood cohort can be further developed to address emergent priorities in the population and environmental health literatures, namely the need for temporally matched data, a lifecourse approach, and analyses that control for spatial scale effects. solid waste management and environment in mumbai (india) by uttam jakoji sonkamble and bairam paswan abstract: mumbi is the individual financial capital of india. the population of greater mumbai is 3,326,837 and 437 sq. km. area. the density of population 21, 190 per sq. km. the dayto-day administration and rendering of public services within gr. mumbai is provided by the brihan mumbai mahanagar palika (mumbai corporation of gr. mumbai) that is a body of 221 elected councilors on a 5-year team. mumcial corporation provides varies conservancy services such as street sweeping, collection of solid waste, removal and transportation, disposal of solid waste, disposal of dead bodies of animals, construction, maintance and cleaning of urinals and public sanitary conveniences. the solid waste becoming complicated due to increase in unplanned urbanization and industrialization, the environment has deteriorated significantly due to inter, intra and international migration stream to mumbai. the volume of inter state migration to mumbai is considerably high i.e. 20.89 lakh and international migrant 0.77 lakh have migrated to mumbai. present paper gives the view on solid waste management and its implications to environment and health. pollution from a wide varity of emission, such as from automobiles and industrial activities, has reached critical level in mumbai, causing respiratory, ocular, water born diseases and other health problems. sources of generation of waste are -household waste, commercial waste, institutional waste, street sweeping, silt removed from drain/nallah/cleanings. disposal of solid waste in gr. mumbai done under 1 incineration 2. processing to produce organic manure. 3. vermi-composting 4. landfill the study shows that the quantity of waste disposal of through processing and conversion to organic ~anure is about 200-240 m.t. per day. the processing is done by a private agency m/s excel industries ltd. who had set up a plant at the chincholi dumping ground in western mumbai for this purpose. the corporation is also disposal a plant of its waste mainly market waste through the environment friendly, natural pro-ces~ known as vermi-composing about 100 m.t. of market waste is disposed of in this manner at the various sites. there are four land fill sites are available and 95 percent of the waste matter generated m mumbai is disposed of through landfill. continuous flow of migrant and increa~e in slum population is a complex barrier in the solid waste management whenever community pamc1pat1on work strongly than only we can achieved eco-friendly environment in mumbai. persons exposed to residential craffic have elevated races of respiratory morbidity an~ ~ortality. since poverty is an important determinant of ill-health, some h~ve argued that t~es~ assoc1at1ons may relate to che lower socioeconomic status of those living along ma1or roads. our ob1ect1ve was to evaluate the association between traffic intensity at home and hospital admissions for respiratory diagnoses among montreal residents older than 60 years. morning peak traffic estimates from the emmej2 montreal traffic model (motrem98) were used as an indicator of exposure to road traffic outside the homes of those hospitalised. the influence of socioeconomic status on the relationship between traffic intensity and hospital admissions for respiratory diagnoses was explored through assessment of confounding by lodging value, expressed as the dollar average over road segments. this indicator of socioeconomic status, as calculated from the montreal property assessment database, is available at a finer geographic scale than socioeconomic information accessible from the canadian census. there was an inverse relationship between traffic intensity estimates and lodging values for those hospitalised (rho -0.23, p 3160 vehicles during che 3 hour morning peak), even after adjustment for lodging value (crude or 1.35, cl95% 1.22-1.49; adjusted or 1.13, cl95% 1.02-1.25). in montreal, elderly persons living along major roads are at higher risk of being hospitalised for respiratory illnesses, which appears not simply to reflect the fact that those living along major roads are at relative economic disadvantage. the paper argues that human beings ought to be at the centre of the concern for sustainable development. while acknowledging the importance of protecting natural resources and the ecosystem in order to secure long term global sustainability, the paper maintain that the proper starting point in the quest for urban sustainability in africa is the 'brown agenda' to improve che living and working environment of che people, especially che urban poor who face a more immediate environmental threat to their health and well-being. as the un-habitat has rightly observed, it is absolutely essential "to ensure that all people have a sufficient stake in the present to motivate them to take part in the struggle to secure the future for humanity.~ the human development approach calls for rethinking and broadening the narrow technical focus of conventional town planning and urban management in order to incorporate the emerging new ideas and principles of urban health and sustainability. i will examine how cities in sub-saharan africa have developed over the last fifty years; the extent to which government policies and programmes have facilitated or constrained urban growth, and the strategies needed to achieve better functioning, safer and more inclusive cities. in this regard i will explore insights from the united nations conferences of the 1990s, especially local agenda 21 of the rio summit, and the istanbul declaration/habitat agenda, paying particular attention to the principles of enablement, decentralization and partnership canvassed by these movements. also, i will consider the contributions of the various global initiatives especially the cities alliance for cities without slums sponsored by the world bank and other partners; che sustainable cities programme, the global campaigns for good governance and for secure tenure canvassed by unhabit at, the healthy cities programme promoted by who, and so on. the concluding section will reflect on the future of the african city; what form it will take, and how to bring about the changes needed to make the cities healthier, more productive and equitable, and better able to meet people's needs. heather jones-otazo, john clarke, donald cole, and miriam diamond urban areas, as centers of population and resource consumption, have elevated emissions and concentrations of a wide range of chemical contaminants. we have developed a modeling framework in which we first ~stimate the emissions and transport of contaminants in a city and second, use these estimates along with measured contaminant concentrations in food, to estimate the potential health risk posed by these che.micals. the latter is accomplished using risk assessment. we applied our modeling framework to consider two groups of chemical contaminants, polycyclic aromatic hydrocarbons (pah) a.nd the flame re~ardants polybrominated diphenyl ethers (pbde). pah originate from vehicles and stationary combustion sources. ~veral pah are potent carcinogens and some compounds also cause noncancer effects. pbdes are additive flame retardants used in polyurethane foams (e.g., car seats, furniture) 105fer sessions v67 and cl~ equipm~nt (e.g., compute~~· televisio~s). two out of three pbdes formulations are being voluntarily phased by mdustry due to rmng levels m human tissues and their world-wide distribution. pbdes have been .related to adv.erse neurological, developmental and reproductive effects in laboratory ijlimals. we apphed our modelmg framework to the city of toronto where we considered the southcattral area of 21 by 21 km that has a population of 1.3 million. for pah, local vehicle traffic and area sources contribute at least half of total pah in toronto. local contributions to pbdes range from 57-85%, depending on the assumptions made. air concentrations of both compounds are about 10 times higher downtown than 80 km north of toronto. although measured pah concentrations in food date to the 1980s, we estimate that the greatest exposure and contribution to lifetime cancer risk comes from ingestion of infant formula, which is consistent with toxicological evidence. the next greatest exposure and cancer risk are attributable to eating animal products (e.g. milk, eggs, fish). breathing downtown air contributes an additional 10 percent to one's lifetime cancer risk. eating vegetables from a home garden localed downtown contributes negligibly to exposure and risk. for pbdes, the greatest lifetime exposure comes through breast milk (we did not have data for infant formula), followed by ingestion of dust by the toddler and infant. these results suggest strategies to mitigate exposure and health risk. p4-01 (a) immigration and socioeconomic inequalities in cervical cancer screening in toronto, canada aisha lofters, rahim moineddin, maria creatore, mohammad agha, and richard glazier llltroduction: pap smears are recommended for cervical cancer screening from the onset of sexual activity to age 69. socioeconomic and ethnoracial gradients in self-reported cervical cancer screening have been documented in north america but there have been few direct measures of pap smear use among immigrants or other socially disadvantaged groups. our purpose was to investigate whether immigration and socioeconomic factors are related to cervical cancer screening in toronto, canada. methods: pap smears were identified using fee codes and laboratory codes in ontario physician service claims (ohip) for three years starting in 1999 for women age 18-41 and 42-66. all women with any health system contact during the three years were used as the denominator. social and economic factors were derived from the 2001 canadian census for census tracts and divided into quintiles of roughly equal population. recent registrants, over 80% of whom are expected to be recent immigrants to canada, were identified as women who first registered for health coverage in ontario after january 1, 1993. results: among 397,967 women age 18-41 and 328,885 women age 42-66, 55.3% and 55.5%, rtspcctively, had pap smears within three years. low income, low education, recent immigration, visible minority and non-english language were all associated with lower rates (least advantaged quintile:most advantaged quintile rate ratios were 0.84, 0.90, 0.81, 0.85, 0.83, respectively, p < 0.05 for all). similar gradients were found in both age groups. recent registrants comprised 22.5% of women and had mm;h lower pap smear rates than non-recent registrants (37.2 % versus 63. 7% for women age 18-41 and 35.9% versus 58.2% for women age 42-66). conclnsions: pap smear rates in toronto fall well below those dictated by evidence-based practice. at the area level, immigration, visible minority, language and socioeconomic characteristics are associated with pap smear rates. recent registrants, representing a largely immigrant group, have particularly low rates. efforts to improve coverage of cervical cancer screening need to be directed to all ~omen, their providers and the health system but with special emphasis on women who recently arrived m ontario and those with social and economic disadvantage. challeges faced: a) most of the resources are now being ~pent in ~reventing the sprea.d of hiv/ aids and maintaining the lives of those already affected. b) skilled medical ~rs~nal are dymg under· mining the capacity to provide the required health care services. ~) th.e comphcat1o~s of hiv/aids has complicated the treatment of other diseases e.g. tbs d) the ep1dem1c has led. to mcrease number of h n requiring care and support. this has further stretched the resources available for health care. orp a s d db . . i methods used on our research: 1. a simple community survey con ucte y our orgamzat1on vo · unteers in three urban centres members of the community, workers and health care prov~ders were interviewed ... 2. meeting/discussions were organized in hospitals, commun.ity centre a~d with government officials ... 3. written questionnaires to health workers, doctors and pohcy makers m th.e health sectors. lessors learning: • the biggest-health bigger-go towards hiv/aids prevention • aids are spreading faster in those families which are poor and without education. •women are the most affected. •all health facilities are usually overcrowded with hiv/aids patients. actions needed:• community education oh how to prevent the spread of hiv/aids • hiv/aids testing need to be encouraged to detect early infections for proper medical cover. • people to eat healthy • people should avoid drugs. implications of our research: community members and civic society-introduction of home based care programs to take care of the sick who cannot get a space in the overcrowded public hospitals. prl-v a te sector private sector has established programs to support and care for the staff already affected. government provision of support to care-givers, in terms of resources and finances. training more health workers. introduction: australian prisons contain in excess of 23,000 prisoners. as in most other western countries, reliance on 'deprivation of liberty' is increasing. prisoner numbers are increasing at 7% per annum; incarceration of women has doubled in the last ten years. the impacts on the community are great -4% of children have a parent in custody before their 16th birthday. for aboriginal communities, the harm is greater -aboriginal and/or torres strait islanders are incarcerated at a rate ten times higher than other australians. 25% of their children have a parent in custody before their 16th birthday. australian prisons operate under state and territory jurisdictions, there being no federal prison system. eight independent health systems, supporting the eight custodial systems, have evolved. this variability provides an unique opportunity to assess the capacity of these health providers in addressing the very high service needs of prisoners. results: five models of health service provision are identified -four of which operate in one form or another in australia: • provided by the custodial authority (queensland and western australia)• pro· vided by the health ministry through a secondary agent (south australia, the australian capital territory and tasmania) • provided through tendered contract by a private organization (victoria and northern territory) • provided by an independent health authority (new south wales) • (provided by medics as an integral component of the custodial enterprise) since 1991 the model of the independent health authority has developed in new south wales. the health needs of the prisoner population have been quantified, and attempts are being made to quantify specific health risks /benefits of incarceration. specific enquiry has been conducted into prisoner attitudes to their health care, including issues such as client information confidentiality and access to health services. specific reference will be made to: • two inmate health surveys • two inmate access surveys, and • two service demand studies. conclusions: the model of care provision, with legislative, ethical, funding and operational independence would seem provide the best opportunity to define and then respond to the health needs of prisoners. this model is being adopted in the united kingdom. better health outcomes in this high-risk group, could translate into healthier families and their communities. p4-04 (a) lnregrated ethnic-specific health care systems: their development and role in increasing access to and quality of care for marginalized ethnic minorities joshua yang introduction: changing demographics in urban areas globally have resulted in urban health systems that are racially and ethnically homogenous relative to the patient populations they aim to serve. the resultant disparities in access to and quality of health care experienced by ethnic minority groups have been addressed by short-term, instirutional level strategies. noticeably absent, however, have been structural approaches to reducing culturally-rooted disparities in health care. the development of ethnic-specific h~alth car~ systems i~ a structural, long-term approach to reducing barriers to quality health care for eth· me mmonty populations. methods: this work is based on a qualitative study on the health care experiences of san francisco chinatown in the united states, an ethnic community with a model ethnic-specific health care infrastrucrure. using snowball sampling, interviews were conducted with key stakeholders and archival research was conducted to trace and model the developmental process that led to the current ethnic-specific health care system available to the chinese in san francisco. grounded theory was the methodology ijltd to analysis of qualitative data. the result of the study is four-stage developmental model of ethnic-specific health infrastrueture development that emerged from the data. the first stage of development is the creation of the human capital resources needed for an ethnic-specific health infrastructure, with emphasis on a bilingual and bicultural health care workforce. the second stage is the effective organization of health care resources for maximal access by constituents. the third is the strengthening and stability of those institutional forms through increased organizational capacity. integration of the ethnic-specific health care system into the mainstream health care infrastructure is the final stage of development for an ethnic-specific infrastructure. conclusion: integrated ethnic-specific health care systems are an effective, long-term strategy to address the linguistic and cultural barriers that are being faced by the spectrum of ethnic populations in urban areas, acting as culturally appropriate points of access to the mainstream health care system. the model presented is a roadmap to empower ethnic communities to act on the constraints of their health and political environments to improve their health care experiences. at a policy level, ethnic-specific health care organizations are an effective long-term strategy to increase access to care and improve qualiiy of care for marginalized ethnic groups. each stage of the model serves as a target area for policy interventions to address the access and care issues faced by culturally and linguistically diverse populations. users in baltimore md: 1989-2004 noya galai, gregory lucas, peter o'driscoll, david celentano, david vlahov, gregory kirk, and shruti mehta introduction: frequent use of emergency rooms (er) and hospitalizations among injection drug users (idus) has been reported and has often been attributed to lack of access to primary health care. however, there is little longitudinal data which examine health care utilization over individual drug use careers. we examined factors associated with hospitalizations, er and outpatient (op) visits among idus over 14 years of follow-up. methods: idus were recruited through community outreach into the aids link to lntravenous experience (alive) study and followed semi-annually. 2,551 who had at least 2 follow-up visits were included in this analysis. outcomes were self-reported episodes of hospitalizations and er/op visits in the prior six months. poisson regression was used accounting for intra-person correlation with generalized estimation equations. hits: at enrollment, 73% were male, 95% were african-american, 33% were hiv positive, median age was 35 years, and median duration of drug use was 15 years. over a total of 37,512 visits, mean individual rates of utilization were 11 per 100 person years (py) for hospitalizations and 123 per 100 py for er/op visits. adjusting for age and duration of drug use, factors significantly associated with higher rates of hospitalization included hiv infection (relative incidence [ri(, 1.4), female gender (ri, 1.2), homelessness (ri, 1.6), as well as not being employed, injecting at least daily, snorting heroin, havmg a regular source of health care, having health insurance and being in methadone mainte.nance treatment (mmt). similar associations were observed for er/op visits except for mmt which was not associated with er/op visits. additional factors associated with lower er/op visits were use of alcohol, crack, injecting at least daily and trading sex for drugs. 10% of the cohort accounted for 45% of total er/op visits, while 11 % of the cohort never reported an op visit during follow-up. . . . lgbt) populations. we hypothesized that prov1dmg .appomtments .for p~t1~nts w1thm 24 hours would ensure timely care, increase patient satisfaction, and improve practice eff1c1ency. further, we anticipated that the greatest change would occur amongst our homeless patients.. . methods: we tested an experimental introduction of advanced access scheduling (usmg a 24 hour rule) in the primary care medical clinic. we tracked variables inclu~ing waiting ti~e fo~ next available appointment; number of patients seen; and no-show rates, for an eight week penod pnor to and post introduction of the new scheduling system. both patient and provider satisfaction were assessed using a brief survey (2 questions rated on a 5-pt scale). results and conclusion: preliminary analyses demonstrated shorter waiting times for appointments across the clinic, decreased no-show rates, and increased clinic capacity. introduction of the advanced access scheduling also increased both patient and provider satisfaction. the new scheduling was initiated in july 2005. quantitative analyses to measure initial and sustained changes, and to look at differential responses across populations within our clinic, are currently underway. introduction: there are three recognized approaches to linking socio-economic factors and health: use of census data, gis-based measures of accessibility/availability, and resident self-reported opinion on neighborhood conditions. this research project is primarily concerned with residents' views about their neighborhoods, identifying problems, and proposing policy changes to address them. the other two techniques will be used in future research to build a more comprehensive image of neighborhood depri· vation and health. methods: a telephone survey of 658 london, ontario residents is currently being conducted to assess: a) community resource availability, quality, access and use, b) participation in neighborhood activities, c) perceived quality of neighborhood, d) neighborhood problems, and e) neighborhood cohesion. the survey instrument is composed of indices and scales previously validated and adapted to reflect london specifically. thirty city planning districts are used to define neighborhoods. the sample size for each neighborhood reflects the size of the planning district. responses will be compared within and across neighborhoods. data will be linked with census information to study variation across socio-eco· nomic and demographic groups. linear and gis-based methods will be used for analysis. preliminary results: the survey follows a qualitative study providing a first look at how experts involved in community resource planning and administration and city residents perceive the availability, accessibility, and quality of community resources linked to neighborhood health and wellbeing, and what are the most immediate needs that should be addressed. key-informant interviews and focus groups were used. the survey was pre-tested to ensure that the language and content reflects real experiences of city residents. the qualitative research confirmed our hypothesis that planning districts are an acceptable surrogate for neighborhood, and that the language and content of the survey is appropriate for imple· mentation in london. scales and indices showed good to excellent reliability and validity during the pre· test (cronbach's alpha from 0.57-0.96). preliminary results of the survey will be detailed at the conference. conclusions: this study will help assess where community resources are lacking or need improve· ment, thus contributing to a more effective allocation of public funds. it is also hypothesized that engaged neighborhoods with a well-developed sense of community are more likely to respond to health programs and interventions. it is hoped that this study will allow london residents to better understand the needs and problems of their neighborhoods and provide a research foundation to support local understandmg of community improvement with the goal of promoting healthy neighborhoods. p4-08 (a) hiv positive in new york city and no outpatient care: who and why? hannah wolfe and victoria sharp introduction: there are approximately 1 million hiv positive individuals living in the united sta!es. about. 50% of these know their hiy status and are enrolled in outpatient care. of the remaining 50 yo, approx~mately half do not know their status; the other group frequently know their status but are not enrolled m any .sys~em of outpatient care. this group primarily accesses care through emergency departments. when md1cated, they are admitted to hospitals, receive acute care services and then, upon poster sessions v71 di5'harge, disappear from the health care system until a new crisis occurs, when they return to the emergency department. as a large urban hiv center, caring for over 3000 individuals with hiv we have an active inpatient service ".'ith appr~xi~.ately 1800 discharges annually. we decided to survey our inpatients to better charactenze those md1v1duals who were not enrolled in any system of outpatient care. results: 18% of inpatients were not enrolled in regular outpatient care: 2% at roosevelt hospital and 35% at st.luke\'s hospital. substance abuse and homelessness were highly prevalent in the cohort of patients not enrolled in regular outpatient care. 84% of patients not in care (vs. 33% of those in care) were deemed in need of substance use treatment by the inpatient social worker. 74% of those not in care were homeless (vs. 15% of those in care.) patients not in care did not differ significantly from those in me in terms of age, race, or gender. patients not in care were asked "why not:" the two most frequent responses were: "i haven't really been sick before" and "i'd rather not think about my health. conclusions: this study suggests that there is an opportunity to engage these patients during their stay on the inpatient units and attempt to enroll them in outpatient care. simple referral to an hiv clinic is insufficient, particularly given the burden of homelessness and substance use in this population. efforts are currently underway to design an intervention to focus efforts on this group of patients. p4.q9 (a) healthcare availability and accessibility in an urban area: the case of ibadan city, nigeria in oder to cater for the healthcare need of the populace, for many years after nigeria's politicl independence, empphasis was laid on the construction of teaching, general, and specialist hospital all of which were located in the urban centres. the realisation of the inadequacies of this approach in adequately meeting the healthcare needs of the people made the country to change and adopt the primary health care (phc) system in 1986. the primary health care system which is in line with the alma ata declaration of of 1978, wsa aimed at making health care available to as many people as possible on the basis of of equity and social justice. thus, close to two decades, nigeria has operated primary health care system as a strategy for providing health care for rural and urban dwellers. this study focusing on urban area, examimes the availabilty and accessibility of health care in one of nigeria's urban centre, ibadan city to be specific. this is done within the contest of the country's national heath policy of which pimary health care is the main thrust. the study also offers necessary suggestion for policy consideration. in spite of the accessibility to services provided by educated and trained midwifes in many parts of fars province (iran) there are still some deliveries conducted by untrained traditional birth attendants in rural parts of the province. as a result, a considerable proportion of deliveries are conducted under a higher risk due to unauthorised and uneducated attendants. this study has conducted to reveal the pro· portion of deliveries with un-authorized attendants and some spatial and social factors affecting the selection of delivery attendants. method: this study using a case control design compared some potentially effective parameters indud· ing: spatial, social and educational factors of mothers with deliveries attended by traditional midwifes (n=244) with those assisted by educated and trained midwifes (n=258). the mothers interviewed in our study were selected from rural areas using a cluster sampling method considering each village as a cluster. results: more than 11 % of deliveries in the rural area were assisted by traditional midwifes. there are significant direct relationship between asking a traditional birth attendant for delivery and mother age, the number of previous deliveries and distance to a health facility provided for delivery. significant inverse relationships were found between mother's education and ability to use a vehicle to get to the facilities. conclusion: despite the accessibility of mothers to educated birth attendants and health facilities (according to the government health standards), some mothers still tend to ask traditional birth attendants for help. this is partly because of unrealistic definition of accessibility. the other considerable point is the preference of the traditional attendants for older and less educated mothers showing the necessity of changing theirs knowledge and attitude to understand the risks of deliveries attended by traditional and un-educated midwifes. p4-12 (a) identification and optimization of service patterns provided by assertive community treatment teams in a major urban setting: preliminary findings &om toronto, canada jonathan weyman, peter gozdyra, margaret gehrs, daniela sota, and richard glazier objective: assertive community treatment (act) teams are financed by the ontario ministry of health and long-term care (mohltc) and are mandated to provide treatment, rehabilitation and support services in the community to people with severe and persistent mental illness. there are 13 such teams located in various regions across the city of toronto conducting home visits 1-5 times per week to each of their approximately 80 respective clients. each team consists of multidisciplinary health professionals who assist clients to identify their needs, establish goals and work toward them. due to complex referral patterns, the need for service continuity and the locations of supportive housing, clients of any one team are often found scattered across the city which increases home visit travel times and decreases efficiency of service provision. this project examines the locations of clients in relation to the home bases of all 13 act teams and identifies options for overcoming the geographical challenges which arise in a large urban setting. methods: using geographic information systems (gis) we geocoded all client and act agency addresses and depicted them on location maps. at a later stage using spatial methods of network analysis we plan to calculate average travel rimes for each act team, propose optimization of catchment areas and assess potential travel time savings. resnlts: initial results show a substantial scattering of clients from several act teams and substan· rial overlap of visit travel routes for most teams. conclusions: reallocation of catchment areas and optimization of act teams' travel patterns should lead to substantial savings in travel times, increased service efficiency and better utilization of resourc_~· ~e l'<!tenri~i modifications to catchment areas must be conducted with appropriate attention to specific clients servtce needs, service continuity and applicable regulations by the mohl tc. venice lido is a popular island within and outside italy because it hosts the international cinema festival yearly. only few people remember the island for its hospital, which, in the fifties, was one of the most important hospitals in italy and in europe, being a modern center for wind-, sun-and thermal-therapy. since the sixties, its fame became to drop away, since its structure was no longer adequate for the evolving medicine science. at the end of the seventies all the wards were moved into a new big building in the same area. at present the hospital is made up by about forty 'pavilions' (mostly partially used or empty) and a big building, disseminated in a 10 hectares area, on the sea front, on the 500 m long beach. the aim of my research is to suggest a realistic solution, sustainable on the functional use of the area according to basic local needs and economically realizable. i used a philological and multi-disciplinary method, more in detail: -from historical documents, i found what was the very first call of the property and how it adapted to the needs of the demographic development and the sanitary supply over time; -by contacting some operators from different fields, i realized which functions were suitable to the buildings in existence, to the population's needs and to the present sanitary supply. moreover the planning idea considers: -the debate going on between local people who strongly want to preserve the property, and die ones who want to renew it by different new opportunities; and -the regional sanitary politics, aiming at rationalizing the regional hospitals dislocation, and the budget needs. this plan analyzes and proposes some new alternative solutions to satisfy different needs. the different activities will be dealt out and the environmental fall will be limited as much as possible. after having analyzed its basic call, considered its environmental peculiarities and its position, verified the emerging needs of the local population, the plan proposes 5 different activities: the hospital; the social-rehabilitation center; the elderly house; the thermal center; the residential center; and other activities. such a plan wants to share in the solution of a basic problem by giving architectonic and functional dignity to an historical completely degraded area and by starting again a social-economical broken off process, by bringing in venice lido some fresh necessary elements for its so wished new throw. p4-14 (c) dilemma of free health care in spokane, wa david bunting introduction: the paper reports on the activities of project access spokane [pas], a physician sponsored initiative to provide uncompensated health care to low income, uninsured residents of spokane county wa. program providers included all county hospitals, over 600 physicians, other medical professionals, and specialized clinics. each prescription requires only a $4 co-payment. sponsored and administered by the county medical society, pas is funded by local and national foundations, private corporations, municipalities, civic organizations and individuals. method: the paper is based on a first year assessment report funded by pas, using hcfa [health care financing administration] insurance claim data documenting utilization rates, disease categories and donated charge information and patient cares [centralized applications, referrals and enrollment status) data. results: while essentially free for enrollees, the program involved real costs. an administrative organization to refer over 700 patients to any of over 800 providers had to be developed and staffed, using both paid and unpaid personnel. methods to identify potential patients and veri.fy eligibility. had to ~devised. patient appointments and transportation had to be scheduled and monitored. pu~hc relanons, provider solicitations and fundraising activities were continuous. information requirements regarding program operation were also significant. data reporting the volume. ~nd value of dona~ed medical services were necessary to demonstrate accomplishments and attr~ct addmon~l support. providers required assurances their contributions were both significant and eqmtable. funding sources sought evidence that their support had important consequences. however, generating this ~~ta proved difficult. many providers failed to submit appropriate insurance claims forms because .of a~dmonal donated effort and administrative cost, thereby not only reducing their own apparent conmbut1ons but also the overall significance of the program. conclusions: during its initial year, the estimated cost to deliver free health care was ~bout 5500 per enrollee. the lesson is that without an elaborate administrative structure and record keeping s.yst~~· efforts to provide free health care probably will fail. eligible enrollees c~n not be ~parated from in~hgi ble ones, care will not be accessed or delivered in an efficient manner, neither fundmg nor ~upport "". 1 11 be offered without evidence of tangible benefits, and providers will withdraw if they perceive mequ1table tteannent. v74 p4-1s (c) mobility in prostitution and the impact of health therese van der helm and henk sulman poster sessions introduction: many of the estimated 8.000 commer~ial ~ex wor~ers (c~w)in a'.'1~terdam ~~me from developing countries and eastern europe. to gain ins~ght mto their workmg and_ hvmg condinons the intermediary project (ip) at the municipal health serv1~e _contacts these women via ?utreach work on regular basis. since the new brothel law in october 2000 1s 1~troduc~d, ~sw ~rom outside the eu and who have no dutch residence permit are not allowed to work m prost1tut10n. smee then, many of these csw therefore have gone "underground." the consequences of the new law in the netherlands will be discussed with regard to the accessibility of csw and their risk for stl/hiv acquisition and unplanned pregnancies. methods: topics during outreach work are the interventions to increase the knowledge of safe sex and birth control for csw. written information is handed out in relevant languages and with addresses of health and social services. in conversations with the women, it appeared that many are not aware of these services. to provide easier access to health care for women, staff of the ip carries out free sti control csw working places, in windows brothels and sex houses. also, women are offered vaccination against hepatitis b (hbv). results: from january 2004 till july 2005 we approached 900 csw for first contact. one third was dutch; others were from developing countries, other eu countries and eastern europe. 350 sti consul· rations were done among non-iv drug using sex workers, of whom 50 % was dutch. of these, 2 % was diagnosed with syphilis, 1 % with gonorrhea, and 9% with chlamydia. of 234 women tested for hiv, none were infected. due to the high turnover of csw in .brothels, most wnmen were tested only once. among 845 csw tested for hbv -of whom one third is dutch -22 % had antibodies for hbv, 12 were carrier of hbv, most of whom came from hbv endemic areas. conclusions: sti control and hbv vaccination in brothels is an important support in health care. our findings suggest that csw do not play an important role in the transmission of sti. many csw are highly mobile and often not aware of the existing health and social services. continuous outreach is important to remain in contact with this mobile population. regulations in the new brothel law should not hamper contacts with (illegal) csw. heart disease (cho) is projected to become the leading cause of death. studies conducted in europe and the united states have proven a higher rate of cho in south asians who have migrated from south asia, most notably india, pakistan and bangladesh. approximately 50% of all heart attacks among south asian men occur under the age of 55; 25% of them occur under the age of 40-unheard of in any other population. associated risk factors such as diabetes, high blood pressure and cholesterol are also com· mon in this group. the population of south asians residing in nyc has more than doubled over the past decade to over 300,000, the majority being young, working-class and with limited health care access. many south asian men are employed as taxi drivers (4 out of 10 nyc taxi drivers are from south asial, working daily12 hour plus shifts. methods: acknowledging that this vulnerable, at-risk group was unavailable for outreach through conventional venues, three of the hospitals of the new york city health and hospital corporation, (elmhurst, queens and bellevue) conducted a one day outreach effort at nyc's jfk international air· ~rt's taxi holdin~ ar~a, ~here over one thousand taxis regularly assemble. bringing an outreach event directly to the taxi dnvers workplace, a tent was set up where cardiovascular-related health screenings, in~luding bl~ pressure, sugar, cholesterol, body mass index (bmi), were provided. results were shared with and explamed to the drivers and each participant received a south asian health education brochure. a total of 84 taxi drivers who identified as south asian were involved. rau/ts: participants were all male, ranging from 20 to 61 years; mean age, 41.5. screenings revealed 57% hypertensive; 46% had cholesterols over 200; 26% blood glucose over 160; 91 % had a bmi greater than 25. conc~on: a unique outreach activity, adapting to logistical, occupational limitations, is pre· se~ted. on-site f~back and explanation of results, reiterating and reinforcing the concern that south asia~. men are at mcreased danger for early coronary heart disease, and the dissemination of a culturally sensmve and r~levant brochure, may heighten awareness of prevailing cardiac risk factors in this immi· grant community. p4-17 (c) the community-hospital integration program framework: community-hospital panoenhips to improve the population's health john stevenson, richard blickstead, ann-marie marcolin, and sandi kendal v75 introduction: st. josephs health centre is a catholic community teaching hospital located in the heart of southwest toronto. st. joseph\'s was founded from a community-expressed need for hospital services, and since then has stayed committed to fostering a healthy community through collaboration and parmership. st. joseph's has developed an innovative model, the community-hospital integration program (chip), to strengthen st. joseph's partnerships with community stakeholders, and facilitates the building of links between community needs, service provision, and public policy outcomes to improve the health and wellness of the diverse neighbourhoods they together serve. methods: development of the chip framework st. joseph's health centre developed the chip framework through a multidisciplinary approach that included extensive international literature reviews, consultations, and key informant interviews with community service agencies and academics. to ensure active community voice, st. joseph's has hosted a number of community consultations including a community outreach forum attended by over ninety representatives from 68 community partners. results: the chip framework the chip framework aims to improve the health and wellness of the urban communities served by st. josephs health centre through four intersecting pillars: • raising community voices provides an infrastructure and process that supports community stakeholder input into health care service planning, decision-making, and delivery by the hospital and across the continuum of care; • sharing reciprocal capacity promotes healthy communities through the sharing of our intellectual and physical capacity with our community partners; • cultivating integration initiatives facilitates vertical, horizontal, and intersectoral integration initiatives in support of community-identified needs and gaps; and • facilitating healthy exchange develops best practices in community integration through community-based research, and facilitates community voice in informing public policy. the chip framework drives the complex inter-relationships between community-hospital engagement, reciprocal capacity-building, integration initiatives, and community-based research and evaluation, to create an interconnected network of health care services. the fluidity and simplicity of this framework, and its dedication to balancing community needs and hospital mandate, posits the st. josephs health centre's chip model as an integral component in building healthy and thriving communities. p4-18 (c) home based care promotion: improving acess to quality services and livelihood in the face of aids home based care is a service provided to persons affected/living with hiv/aids, a menu of care/support services at home/community. it is a prominent alternative approach. in uganda, hospital bed ocupacny is high, patient health care worker ratio deteriorating. empowering communities offers solutions to the problems; adressing cost, effectiveness of care. hiv/aids demands changes in attitudes, behaviour, approaches which is enhanced in home/community settings. for example art requires high levels of adherecnce, which medical workers have vety little opportunity to enforce. it also demands other support mechanisims in terms of nutrition, personal displine, etc which work best in stigma free environments. hence the relevance of home based care. this paper highlights the gaps that call for increased action in terms of home based care, examples of whre it has worked key challenges and recommendations for the future. p4-19 (c) health care for one ... health care for alli katharina kovacs burns introduction: at the surface, it appears that every person in canada _has. ~ccess to a publicly funded health care system. those living in urban centers should have the best ava1l~b1hty, chmce, and access to a variety of health care services because of the distribution of health care services, fac1lmes, and health professionals in concentrated in urban centers. this is not true for everyone -people with low income or who are homeless experience the challenges of social exclusion and being marginalized: there are many factors at play making it difficult for the latter group of people to access health care. service they need,.when they need them. health care is not as accessible or inclusive as intended. the quesuon to be explore.cl 1~: if health care is available and accessible to one person, what makes it not available to all people? the ~1gmfic~nce of having marginalized people accessing health care and other services includes e~hanced quality of hfe and decreased risks associated with being homeless, and cost savings in ion~ ter~ w1rh acute health care. methodology: community-based participatory research is applied m a case study on health care access and challenges experienced by low income and homeless people in one urban centre, edmonton, edmonton, and their challenges. the data is being gathered and ana_lyzed usmg basic m1x~d methods. results: the results will focus on how services can be more mtegrated and accessible to all people with low income and who are homeless. there will also be discussion about specific perceptions of not only the service providers but also of people with low income an~ who are homeless~ and vario~s decision makers. the results will be compared to the literature regardmg health care services access mother urban centers in canada and elsewhere. conclusions: recommendations will need to address social exclusion and other factors which can make health care and other services more available to all people in the community. the implications for health care will also be discussed. additional information will be gathered in the next phases of the study to develop a community services access model. p4-20 (c) availability and access exemplified: a case study beth hayhoe and ruth ewert introduction: access to health care in canada requires either the correct documentation or money. street youth have neither. in addition, health services in canada are designed by adults for adults. youth in general are often wary of having trust in adults with respect to their health concerns and frequently feel misunderstood. street youth are even more mistrustful of adults and public organizations, making their contact with health care professionals minimal. this combined with their risky behaviours and dangerous environment creates a population at risk for numerous health issues but with no place to have them investi· gated. at our non-government, not for profit health service designed specifically to provide a broad range of health care to street youth, professional services are provided almost entirely by volunteers. methods: using a retrospective analysis of the 11 years of data gathered from this organization and reviewing the initial reasons gathered from youth about their needs, the success of the health centre was examined. results: all the things youth had listed as being important in a health centre have been implemented, and even more things have been added to improve the breadth and quality of services offered. the use of the health centre has increased by more than six times since its opening in 1994. in addition, tens of thousands of visits have been paid to the health centre, costing the government and taxpayers nothing. as far as we know there is nothing else in canada that offers so many diverse and innovative services to youth in need. conclusion: it is clear from this case, that health care targeted at the needs of specific disadvan· taged populations can successfully provide them with appropriate health care. a model of accessible health care for marginalized populations can easily be developed for high impact and low cost from this successful case. toronto is one of the most ethno-racially diverse cities in the world of the estimated 2,529,280 toronto residents, 24% (597,218) live in scarborough population growth in scarborough is faster than toronto. scarborough's population increased by 6% from 1996 to 2001 while toronto increased only by 4%. toronto's population is projected to increase by 10% (252 000) in 2011 while scarbor· ough's will increase by 12%. (census canada 2001) low income, pove;ty, seniors, hidden homeless, new~omers to canada, the uninsured, are just a few of the issues concerning health care in our community. health care needs in scarborough are greatly impacted by diversity of ethnic and racial groups, poverty and settlement issues. this paper will share how the scarborough hospital (tsh) an urb~n communir_y hospital cares f~~ it~ community. tsh recognizes: •the changing community• b_arriers t~ accessing care • lnequalmes m health care the hospital in caring for its community pro· v1~es services that '!'e~e cu~turally, racially, and linguistically sensitive to our community. the paper will share the hospitals unique program on access and equity. the paper will share the needs in scar· borough and tsh's response to these needs: working in partnership with the local health committee, i:ne scarborough homeless co.mminee, the scarborough network of immigrant services organiza· nons a~d others. 1:'1e paper will also share the many initiatives this urban community hospital has taken viz. community and home programs in service areas such as mental health, haemodialysis day care, t~~ home oxyg~n program, the palliative at-home program, and above all support for the volunteer clinic for the uninsured. j"'"1tllu:lion: in canada's universal health care system it is generally assumed that everyone has equal access to health care. however, some immigrant groups in canada have historically been uninswed. these groups include failed refugee claimants, those overstaying their visas, and new immigrants in transition who are waiting to become eligible for health insurance. some estimates have suggested that at the present time there may be as many as one hundred thousand undocumented and thus uninsured immigrants in toronto alone. understandably, information on the characteristics of this marginalized population is very limited, since undocumented immigrants tend to have little contact with formal institutions. knowledge of the demographic characteristics of this population may aid in the development of health and social programs to better identify and meet the needs of undocumented immigrants in toronto. we conducted a review of all undocumented, uninsured patients, 15 years of age or older at access alliance multicultural community health centre (aamchc) between 1994 and 2004. demographic information such as age, gender, preferred language, length of time living in canada, selfreported education level and household income were recorded. rmdts: 72% of all adult patients at access alliance were undocumented and uninsured. 80% were under40years of age (with a median age of 30 years), 72% were women and only 19% spoke english. this group lived in canada for an average period of 2.2 years before they were first seen at aamchc. 74% of undocumented clients reported having completed at least a secondary or post-secondary education. 81% had self-reported household incomes of less than 20,000$/year, while 97% of households reported earning less than $30,000/year. the mean income per person in an average household was 425$/month. conchuions: uninsured individuals at aamchc were predominantly young females with limited knowledge of the english language. despite having attained a high level of education most were living well below the poverty line. recognition of these characteristics may assist in the development of health and social programs that are better adapted to meet the needs of undocumented immigrants. p4-23 (c) sharing expertise: a role for the hospital lactation consultant in the community. badrgrmuul: st. michael's hospital is a tertiary care hospital that serves a large inner city population in downtown toronto. in order to provide care to this population, the hospital has developed a number of unique outreach roles. one such role was developed to work with pregnant and breastfeeding women living in regent park, a social housing complex located near the hospital. the population of regent park includes new immigrants, refugees and the socially disadvantaged. approach: the outreach lactation consultant provides care, as part of the canada prenatal nutrition program, in the community prenatally, in the hospital during their inpatient stay and postnatally when they return to the community. the continuity of care enhances the probability of long term successful breastfeeding. aside from the health benefits of breastmilk, breastfeeding is especially important for women who are financially needy and must depend on food banks for formula. . . lason learned: aher two years of partnership, the relationship between the an-hospital ~stpar tum experience for breastfeeding mothers and the community postpartum support, the breastfeeding rate ~thin this community is high. the professional support and visibility of the 1:8ctation consultant, both m the hospital and in the community, contributes to the support of breastfee~m~.. . in light of ongoing funding constraints, this ha1son between hospital and community could be at risk and discontinued. in light of the benefits to the mother/baby dyad, the lactation consultant as a community partner in the canada prenatal nutrition program should be safeguarded. . lldpodiu:tion: although the importance of adequate health care in pregna~cy is well recognised, ethnic disparities in utilization of prenatal care still exist in many western coun~~es. a fun~amental factor in these disparities may be language proficiency, as it influences women's ab1hty. to ob~m and understand health information, to find the way in the health care system and to communicate with health care v78 poster sessions providers. we investigated the role of language proficiency in use and knowledge of folic acid as aspect of prenatal care in an urban multi-ethnic pregnancy c?hort. . . design: prospective cohort study. setting and parnc1pants: amsterdam ~regnant women attending obstetric care providers for their first antenatal visit (n= 8050). country of birth defined ethnicity: the netherlands, surinam, antilles, turkey, morocco, ghana, other non-~est~m (nw) and other western (w) country. main outcome measures: knowledge about and use of.fohc a~d (fa) supplements in pregnancy, and determinants of these in diffe~~t ethnic ~~ups. deterrrunants mcl~ded age, ed~ tion, parity, pregnancy intention and dutch prof1c1ency. stansncs: ~2 to co~p~re e~c groups, stranfied logistic regression (forward stepwise method) to explore determmants "'.'thm ethmc groups .. use of fa supplements was significantly lower among ghanaian, moroccan, turkish and other nw women (21%to41 %) than among dutch (86%) or other w women (78%). use amongsurinames and antillean women was intermediate (51%and60%). ethnic differences in fa knowledge were similar. knowledge was the strongest determinant of use in all ethnic groups, with odds ratios (ors) ranging from 10.9 to 42.0. language proficiency was the strongest determi~a~t of kno~ledge in ethnic groups with a mother tongue different from dutch (ors good vs. low proficiency ranging from 3.2 ro 16.0). educational level had a modifying role, as shown by an interaction effect between education and language proficiency in the nw group. here, the odds of having fa knowledge given a high education and good dutch proficiency was 20 times the odds given a good proficiency but low education. conclusions: appropriate periconceptional use of folic acid supplements in non-western ethnic groups is low, reflecting an absence of knowledge that is largely determined by the inability to speak and understand the language of the habitual country. tailored interventions using communication channels most likely to address (pregnant) women from ethnic minority groups are necessary. apan from specific interventions, our results are in support of strong incentives on language education despite current political debate. introduction: recent research suggests living in an economically disadvantaged neighborhood is asso· ciated with decreased likelihood of undergoing mammography and increased risk of late-stage breast can· cer diagnosis. long distances and travel times to facilities offering low-or no-cost mammography may be imponant barriers to adherence to mammography screening recommendations for residents of economically disadvantaged neighborhoods. the purpose of this study was to examine whether facilities providing low-and no-cost screening mammography were less spatially accessible in low-income neighborhoods in chicago, and the extent to which the relationship between neighborhood income and the spatial accessibility of facilities varied by the proponion of african-american residents in the neighborhood. methods: the sample consisted of 343 chicago neighborhoods. for each neighborhood, we con· structed three measures of the spatial accessibility of facilities: street network distance to the nearest facility, public transportation travel time to the nearest facility, and shortest automobile travel time to a facility. using 2000 decennial census data, we characterized the neighborhoods according to proportion of residents with incomes below the poverty line, proportion of residents in each of four raciavethnic groups (african-american, latino, white, and other), and population density. we used ordinary least squares (ols) and spatial exogenous lag regression to examine relationships. model 1 estimated the relationship between neighborhood poverty and the spatial accessibility of facilities, adjusting for raciaveth· nic composition and population density. model 2 added a multiplicative interaction term between neighborhood poverty and african-american. restllts: we identified deven facilities that provided low-or no-cost screening mammography to chicago residents in 2004. we found that the distance and travel times via automobile and public trans· portation to facilities generally decreased as neighborhood poveny increased. however, we also found that the ~egative associations between neighborhood poverty and two of the spatial accessibility mea· sures -distance and public transportation travel time -were less strong in neighborhoods with the highest proponions of african-american residents. among neighborhoods in the highest tertile for poveny, th~ mean distance and mean public transportation travel time to facilities were over twice as long in neighborhoods in the highest tertile than in those in the lowest tenile of african-american residents. . ~ persistent socioeconomic and racial/ethnic disparities in breast cancer stage at diagno-s11 ~nd su~1val suggest that ensuring an equitable distribution of affordable mammography is a worth-w~e policy .goal. the ~~dy sugges~ that ~ture investigations should consider both neighborhood soc1oecono1d1c charactensbes and rac1avethmc composition when examining the spatial distribution of health resources. , 2004) . epidemiological data suggest tha~ hiv prevalence among msm is over 1 % in some metropolitan cities, such .as beijing (ibid.). due to widespread homophobia in chinese society, however, this population remains invisible within current health/social services. lack of research on sexuality, specifically homosexuality, has impaired our understanding of health and health practices of chinese msm. focusing on the illness experiences of chinese msm with hiv/aids, this paper explores the socio-cultural impacts of hiv/ aids on this group. the data used for this paper were collected through semi-constructed in-depth face-toiace interviews with 21 adult plwhas (including 11 msm) in beijing, china. with the permission of the participants, the interviews were audio-taped or recorded in notes. the transcribed interviews and interview notes were analyzed by using n-vivo, a software program for qualitative data analysis. this phenomenological study aimed to understand the experiences chinese plwhas (including msm) from their own perspectives. results: it is found that the illness experiences of chinese msm with hiv/aids are profoundly shaped by the socio-cultural meanings of homosexuality, which are further complicated by the dominant discourses on hiv/aids in china. at a macro level, homophobia in the larger society has decreased the capability of this group to respond to this epidemic in a more efficient way. at a meso level, aids-phobia within the chinese msm circuits has prevented this group from openly confronting this disease and offering support to those who are already affected by it. at a micro level, however, these hiv-infected/ affected msm have tried their best to locate spaces to live and to construct hope for their future lives despite various barriers within family, community, and the larger society. this study suggests that facilitating chinese msm's response to the aids crisis urgently requires bridging awareness, commitment, knowledge and resources both within and without this group. it also illustrates the importance of understanding homosexuality in the local context of hiv i aids, which will be helpful for developing culturally sensitive hiv/aids programs for this population on the community, national and international levels. introduction: having a regular family doctor (rfd) is known to be positively correlated with a good medical follow up, including access to preventive and/or chronic care. inversely, a lack of primary care may lead to high rates of avoidable hospitalizations, especially among poor people and/or in underserved neighbourhoods. in such a matter, a recent comparative study showed that paris was better ranged than other cities, such as nyc, tokyo or london. nevertheless, despite a quasi universal health insurance and a high density of general practitioners, a noticeable fraction of the paris population does not have any regular physician and we aimed to understand who they are and for what reasons rhey don't have any rfd. mdbods: cross sectional population survey among a random sample of households in 2 ~nderpriv ileged neighbourhoods in paris inner city, performed in 2003, using a face-to-face quest10nna1re collecr-1ng more than 400 social and health characteristics. ruults: a quarter (26.3 %) of rhe study popularion did not have any rfd. this proporrion was iignificantly higher among male (or= 2.00, 95%ci = [ 1.41-2.781), younger (e.g. or 18 -29/> .s l _= 4._oo, 95"1.ci = (2.13-7.69)), and/or unemployed (or =2.01, 95%ci = ij .21-3.3411_ people. in multtvanate analysis, after a full adjustment on gender, age, health status, health insura~ce, income, occupat10n and tducation level, we observed significant associations between having no rfd and: ~arrtal and_ pare~t hood status (e.g. or single no kids/in couple+kids = 2.12, 95%ci = ( 1.26-3.59()~ quality of relattonsh1ps with neighbours (or bad/good= 3 .82, 95%ci = [ 1.84-7.94)), and length of residence m the neighbourhood (with a dose/effect statistical relationship). . co11clusion: gender, age, employment status, mariral and parenthood stat~s as well as ~e1gh bourhood anchorage seem to be major predictors of having a rfd, even when um.versa! health i~sur ance has reduced most of financial barriers. in urban contexts, where residential migrattons and single lift (or family ruptures) are frequent, specific information may be conducted to encourage people to ket rfd. :tu~y tries to assess the health effects and costs and also analyse the availability and accessibility to health care for poor. . methods: data for this study was collected by a survey on 300 households of the local community living near the factories and 100 households where radiation hazard w~s n?~ present. ~~art from mor· bidity status and health expenditure, data was collected ~n access, a~ail~b1.hty and eff1c1ency of healrh care. a discriminant analysis was done to identify the vanables that d1scnmmate between the study and control group households in terms of health care pattern. a contingent valuation survey was also undertaken among the study group to find out the factors affecting their willingness to pay for health insurance and was analysed using logit model. results: the health costs and indebtedness in families of the study group was high as compared to control group households and this was mainly due to high health expenditure. the discriminant analysis showed that expenditure incurred by private hospital inpatient and outpatient expenditure were significant variables, which discriminated between the two types of households. the logit analysis showed !hat variables like indebtedness of households, better health care and presence of radiation induced illnesses were significant factors influencing willingness to pay for health insurance. the study showed that study group households were dependent on private sector to get better health care and there were problems with access and availability at the public sector. conclusion: the study found out that the quality of life of the local community is poor due to health effects of radiation and the burden of radiation induced illnesses are so high for them. there is an urgent need for government intervention in this matter. there is also a need for the public sector to be efficient to cater to the needs of the poor. a health insurance or other forms of support to these households will improve the quality for health care services, better and fast access to health care facilities and reduces the financial burden of the local fishing community. the prevalence of substance abuse is an increasing problem among low-income urban women in puerto rico. latina access to treatment may play an important role in remission from substance abuse. little is known, however, about latinas' access to drug treatment. further, the role of social capital in substance abuse treatment utilization is unknown. this study examines the relative roles of social capital and other factors in obtaining substance abuse treatment, in a three-wave longitudinal study of women ages 18-35 living in high-risk urban areas of puerto rico, the inner city latina drug using study (icldus). social capital is measured at the individual level and includes variables from social support and networks, familism, physical environment, and religion instruments of the icdus. the study also elucidates the role of treatment received during the study in bringing about changes in social capital. the theoretical framework used in exploring the utilization of substance abuse treatment is the social support approach to social capital. the research addresses three main questions: ( t) does social capital predict parti~ipating in treatment programs? (2) does participation in drug treatment programs increase social capital?, and (3) is there a significant difference among treatment modalities in affecting change in ~ial capital? the findings revealed no significant association between levels of social capital and gettmg treatment. also, women who received drug treatment did not increase their levels of social capital. the findings, however, revealed a number of significant predictors of social capital and receiving drug ~buse treatment. predictors of social capital at wave iii include employment status, total monthly mcoi:rie, and baseline social capital. predictors of receiving drug abuse treatment include perception of physical health and total amount of money spent on drugs. other different variables were associated to treatment receipt prior to the icldus study. no significant difference in changes of social capital was found among users of different treatment modalities. this research represents an initial attempt to elucidate the two-way relationship between social capital and substance abuse treatment. more work is necessary to unden~nd. ~e role of political forces that promote social inequalities in creating drug abuse problems and ava1lab1hty of treatment; the relationship between the benefits provided by current treatment poster sessions v81 sctrings and treatment-seeking behaviors; the paths of recovery; and the efficacy and effectiveness of the trtaanent. and alejandro jadad health professionals in urban centres must meet the challenge of providing equitable care to a population with diverse needs and abilities to access and use available services. within the canadian health care system, providers are time-pressured and ill-equipped to deal with patients who face barriers of poverty, literacy, language, culture and social isolation. directing patients to needed supportive care services is even more difficult than providing them with appropriate technical care. a large proportion of the population do not have equitable access to services and face major problems navigating complex systems. new approaches are needed to bridge across diverse populations and reach out to underserved patients most in need. the objective of this project was to develop an innovative program to help underserved cancer patients access, understand and use needed health and social services. it implemented and evaluated, a pilot intervention employing trained 'personal health coaches' to assist underserved patients from a variety of ethno-linguistic, socio economic and educational backgrounds to meet their supportive cancer care needs. the intervention was tested with a group of 46 underserved cancer patients at the princess margaret hospital, toronto. personal coaches helped patients identify needs, access information, and use supportive care services. triangulation was used to compare and contrast multiple sources of quantitative and qualitative evaluation data provided by patients, personal health coaches, and health care providers to assess needs, barriers and the effectiveness of the coach program. many patients faced multiple barriers and had complex unmet needs. barriers of poverty and language were the easiest to detect. a formal, systematic method to identify and meet supportive care needs was not in place at the hospital. however, when patients were referred to the program, an overwhelming majority of participants were highly satisfied with the intervention. the service also appeared to have important implications for improved technical health care by ensuring attendance at appointments, arranging transportation and translation services, encouraging adherence to therapy and mitigating financial hardship -using existing community services. this intervention identified a new approach that was effective in helping very needy patients navigate health and social services systems. such programs hold potential to improve both emotional and physical health out· comes. since assistance from a coach at the right time can prevent crises, it can create efficiencies in the health system. the successful use of individuals who were not licensed health professionals for this purpose has implications for health manpower planning. needle exchange programs (neps) have been distributing harm reduction materials in toronto since 1990. counterfit harm reduction program is a small project operated out of a community health centre in south-east toronto. the project is operated by a single full-time coordinator, one pan-rime mobile outreach worker and two peers who work a few hours each week. all of counterfit's staff, peers, and volunteers identify themselves as active illicit drug users. yet the program dis~rib utes more needles and safer crack using kits and serves more illicit drug u~rs t~an the comb1~e~ number of all neps in toronto. this presentation will discuss the reasons behind this success, .s~1f1cally the extended hours of operation, delivery models, and the inclusion of an. extremely marg1~ahzed community in all aspects of program design, implementation and eva.luat1?n. ~ounterfit was recently evaluated by drs. peggy milson and carol strike, two leading ep1dem1olog1st and researchers in the hiv and nep fields in toronto and below are some of their findings: "the program has experienced considerable success in delivering a high quality, accessible and well-used program .... the pro· gram has allowed (service users) to become active participants in providing. services to others and has resulted in true community development in the best sense. " ... counterf1t has ~~n verr succe~sful attracting and retaining clients, developing an effective peer-based model an.d assisting chen~s ~1th a vast range of issues .... the program has become a model for harm red~ctmn progr~ms withm the province of ontario and beyond." in june 2004, the association of ?ntano co~mumty heal~~ <:en· ires recognized counterfit's acheivements with the excellence m community health initiatives award. in kenya, health outcomes and the performance of government health service~ have det~riorated since the late 1980s, trends which coincide with a period of severe resource constramts necessitated by macro-economic stabilization measures after the extreme neo-liberalism of the 1980s. when the govern· ment withdrew from direct service provision as reform trends and donor advocacy suggested, how does it perform its new indirect role of managing relations with new direct health services providers in terms of regulating, enabling, and managing relations with these health services providers? in this paper therefore, we seek to investigate how healthcare access and availability in the slums of nairobi has been impacted upon by the government's withdrawal from direct health care provision. the methodology involved col· leering primary data by conducting field visits to 8 health institutions located in the slum areas of kibera and korogocho in nairobi. purposive random sampling was utilized in this study because this sampling technique allowed the researcher(s) to select those health care seekers and providers who had the required information with respect to the objectives of the study. in-depth interviews using a semi-structured ques· tionnaire were administered ro key informants in health care institutions. this sought to explore ways in which the government and the private sector had responded and addressed in practical terms to new demands of health care provision following the structural adjustment programmes of the 1990s. this was complemented by secondary literature review of publications and records of key governmental, bilateral and multilateral development partners in nairobi. the study notes a number of weaknesses especially of kenya's ministry of health to perform its expected roles such as managing user fee revenue and financial sustainability of health insurance systems. this changing face of health services provision in kenya there· fore creates a complex situation, which demands greater understanding of the roles of competition and choice, regulatory structures and models of financing in shaving the evolution of health services. we rec· ommend that the introduction of user fees, decentralization of service provision and contracting-out of non-clinical to private and voluntary agencies require a new management culture, and new and clear insri· tutional relationships. experience with private sector involvement in health projects underlines the need not only for innovative financial structures to deal with a multitude of contractual, political, market and risks, but also building credible structures to ensure that health services projects are environmentally responsive, socially sensitive, economically viable, and politically feasible. purpose: the purpose of this study is to examine the status of mammography screening utilization and its predictors among muslim women living in southern california. methods: we conducted a cross-sectional study that included 202 women aged ::!: 40 years. we col· leered data using a questionnaire in the primary language of the subjects. the questionnaire included questions on demography; practices of breast self-examination (bse) and clinical breast examination (cbe); utilization of mammography; and family history of breast cancer. bivariate and multiple logistic regression analyses were performed to estimate the odds ratios of mammography use as a function of demographic and other predictor variables. . results: among the 202 women, 78% were married, 68% were 40-50 years old, and 20% had family h1story of breast cancer. thirty-two percent of the participating women never practiced bse and 32% had not undergone cbe during the past two years. the data indicated that 46% of the women did not have mammography in the last two years. logistic regression analysis showed that age (0r=5.1, 95% confi· dcnc~ interval (cl)=l.8-14.2), having clinical breast examination (0r=24.9, 95% cl=8.4-73.7), and practtce of self-breast examination (0r=2.6, 95% cl= 1.1-6.2), were strong predictors of mammography use . . conclusions: the data point to the need for intervention targeting muslim women to inform and motivate th.cm a~ut practices for early detection of breast cancer and screening. further studies are needed to investigate the factors associated with low utilization of mammography among muslim women population in california. we conducted a review of the scientific literature and° government documents to describe ditnational health care program "barrio adentro" (inside the neighborhood). we also conducted qualiurivt interviews with members of the local health committees in urban settings to descrihe the comm unity participation component of the program. rtsmlts: until recently, the venezuelan public health system was characterized by a lack or limited access w health care (70% of the population) and long waiting lists that amounted to denial of service. moit than half of the mds worked in the five wealthiest metropolitan areas of the country. jn the spring oi2003, a pilot program hired 50 cuban mds to live in the slums of caracas to provide health care to piople who had previously been marginalized from social programs. the program underwent a massive expansion and in only two years 20,000 cuban and 6,500 venezuelan health care providers were working acmss the country. they provide a daily average of 20-40 medical consultations and home visits, c1lly out neighborhood rounds, and deliver health prevention initiatives, including immunization programs. they also provide generic medicines at no cost to patients, which treat 80% of presenting ill-ij!m, barrio adentro aims to build 8,000 clinics (primary care), 1,200 diagnostic and rehabilitation ctnrres (secondary care), and upgrade the current hospital infrastructure (tertiary care). local health committees survey the community to identify needs and organize a variety of lobby groups to improve dit material conditions of the community. last year, barrio adentro conducted 3.5 times the medical visits conducted by the ministry of health. the philosophy of care follows an integrated approach where btalrh is related to housing, education, employment, sports, environment, and food security. conclusions: barrio adentro is a unique collaboration between low-middle income countries to provide health care to people who have been traditionally excluded from social programs. this program shows that it is possible to develop an effective international collaboration based on participatory democracy. low-income americans are at the greatest risk of being uninsured and often face multiple health concerns. this evaluation of the neighborhood health initiative (nh!), an organization which uses multiple programmatic approaches to meet the multiple health needs of clients, reflected the program's many activities and the clients' many service needs. nh! serves low-income, underserved, and hard-to-reach residents in the des moines enterprise community. multiple approaches (fourth-generation evaluation, grounded theory, strengths-and needs-based) and methods (staff and client interviews, concept mapping, observations, qualitative and quantitative analysis) were used to achieve that reflection. results indicate good targeting of residents in the 50314 zip code and positive findings in the way of health insurance coverage and reported unmet health needs of clients. program activities were found to match client nttds, validating the organization\'s assessment of clients. important components of nhi were the staff composition and that the organization had become part of both the formal and informal networks. nhi 1 1 positioned as a link between the target population and local health and social sc:rvice agencies, working to connect residents with services and information as well as aid local agencies in reaching this underserved population. p4-36 (c) welfare: definition by new york city maribeth gregory for an individual who resides in new york city, to obtain health insurance under the medicaid policy one must fall under certain criteria .. (new york city's welfare programs 2003) if the individual _is on ssi or earns equal to or less than $934 per month, he is entitled to receive no more than $5,600 m resources. a family the size of two would need to earn less than $942 per month to qualify for no greater than ss,650 worth of medicaid benefits. a family of three would qualify for $5,650 is they earned less than $942 per month and so on. introduction: the vancouver gay communiry has a significant number of asian descendan!l. because of their double minority status of being gay and asian, many asian men who have sex with men (msm) are struggling with unique issues. dealing with racism in both mainstream society and the gay communiry, cultural differences, traditional family relations, and language challenges can be some of their everyday srruggles. however, culturally, sexually, and linguistically specific services for asian msm are very limited. a lack of availability and accessibiliry of culturally appropriate sexual health services isolates asian msm from mainstream society, the gay community, and their own cultural communities, deprives them of self-esteem, and endangers their sexual well-being. this research focuses on the qualita· tive narrative voices of asian msm who express their issues related to their sexualiry and the challenges of asking for help. by listening to their voices, practitioners can get ideas of what we are missing and how we need to intervene in order to reach asian msm and ensure their sexual health. methods: since many asian msm are very discreet, it is crucial to build up trust relationships between the researcher and asian msm in order to collect qualitative data. for this reason, a community based participatory research model was adopted by forming a six week discussion group for asian msm. in each group session, the researcher tape recorded the discussion, observed interactions among the participants, and analyzed the data by focusing on participants' personal thoughts, experiences, and emotions for given discussion topics. ra11lts: many asian msm share challenges such as coping with a language barrier, cultural differ· ences for interpreting issues and problems, and westerncentrism when they approach existing sexual health services. moreover, because of their fear of being disclosed in their small ethnic communities, a lot of asian msm feel insecure about seeking sexual health services when their issues are related to their sexual orientation. conclflsion: sexual health services should contain multilingual and multicultural capacities to meet minority clients' needs. for asian msm, outreach may be a more effective way to provide them with accessible sexual health services since many asian msm are closeted and are therefore reluctant to approach the services. building a communiry for asian msm is also a significant step toward including them in healthcare services. a communiry-based panicipatory approach can help to build a community for asian msm since it creates a rrust relationship between a worker and clients. p4-38 (c) identifying key techniques to sustain interpretation services for assisting newcomers isolated by linguistic and cultural barriers from accessing health services s. gopi krishna lntrodaetion: the greater toronto area (gta) is home to many newcomer immigrants and other vulnerable groups who can't access health resources due to linguistic, cultural and systemic barriers. linguistic and cultural issues are of special concern to suburbs like scarborough, which is home to thousands of newcomer immigrants and refugees lacking fluency in english. multilingual community ~nterpreter. service~ (mcis) is a non-profit social service organization mandated to provide high quality mterpretanon services. to help newcomers access health services, mcis partnered with the scarborough network of immigrant serving organizations (sniso) to recruit and train volunteer interpreters to accompany clienrs lacking fluency in english and interpret for them to access health services at various locati?ns, incl~~ing communiry ~c:-lth centres/social service agencies and hospitals. the model envisioned agencies recruin~ and mcis ~.mm.g and creating an online database of pooled interpreter resources. this da.tabase, acces&1bl~ to all pama~~g ?rganization is to be maintained through administrative/member · ship fees to. be ~1d by each parnapanng organization. this paper analyzes the results of the project, defines and identifies suc:cases before providing a detailed analysis for the reasons for the success . . methods:. this ~per~ q~ntitative (i.e. client numben) and qualitative analysis (i.e. results of key •~ormant m~rv1ews with semce ~sers and interpreters) to analyze the project development, training and 1mplementanon phases of the project. it then identifies the successes and failures through the afore· mentioned analysis. poster sessions vss resljts: the results of the analysis can be summarized as: • the program saw modest success both ia l?lllls of numbers of clients served as well as sustainability at various locations, except in the hospital iririog. o the success of the program rests strongly on the commitment of not just the volunteer interprmr, but on service users acknowledgments through providing transponation allowance, small honororia, letter of reference etc. • the hospital sustained the program better at the hospital due to the iolume and nature of the need, as well as innate capacity for managing and acknowledging volunceers. collc/llsion: it is possible to facilitate and sustain vulnerable newcomer immigrants access to health !ul'ices through the training and commitment of an interpreter volunteer core. acknowledging volunteer commitment is key to the sustenance of the project. this finding is important to immigration and health policy given the significant numbers of newcomer immigrants arriving in canada's urban communities. nity program was established in 1993 to provide support to people dying at home, especially those who were waiting for admission to the resi<lential hospice. with the advent of haart and corresponding challenges for people living with hiv/aids in the community, the community program has developed a unique case management approach. this model features an interdisciplinary team providing a clientdrivcn service. the case manager provides continuity of care to clients in a variety of settings both within and outside of the health care system. a case study is used to demonstrate how formal and informal networks of support facilitate efficient and appropriate resource utilization to promote client health. this case study demonstrates the value of consistent coordination with a client who has complex physical, spiritual, substance use and mental health needs. the authors will show how they liaised with the housing authority, police, social services as well as the family physician, clinic staff and a hospital emergtncy room to ensure this client did not fall between the cracks. tarek hussain recognition of the importance of community involvement and sectoral cooperation in health and !ocial services, formalized in alma-ata declaration in 1978, was reinforced at riga meeting held at the mid·point between alma-ata and the year 2000. then at the 20th anniversary of alma-ata declaration, ir was declared that 'primary health care is everybody's business'. health does not exist in isolation. health cannot be defined only as an outcome of 'medical care' but also as one of 'social action'; the responsibility of disease prevention and health promotion rests not only on governments, but also with don·govemmentorgan izations, the community, and individuals. the major accomplishment to date may be that rhere is growing realization in the health sector that community involvement is more than a political right-it is absolute necessary. lessons have learned during the implementation of disease-specific l'cltical programmes, such as cdd, ari, and epi; first, integrated and holistic approaches to childcare art needed, and second, the need for community involvement has become evident. imc! is a broad inte-gra1ed strategy with an overall objective contributing to reducing child morbidity and mortality in developing countries. and one of the imci components, 'community !mci', which is now broadening ~s an entry point for child-focused community development initiatives. community jmcl/c~1ld health is ~n mtcgrated approach to the promotion of key family and community practices that have impact on: child growth and development, disease prevention, home care for sick, malnourished child~en, a.nd care-seekmg behavior and compliance with advice and treatment. the presentation addres~es, m brief, the ~evel opinent of community !mci, operational aspect of community/im cl, key strategies and tools ava1la~le for implementation of c/imci. the paper draws some successful programme examples on working logether for imc! with the community in various countries which had substantial benefns on programme outcomes. p4-4 t (c) healthy child screening: an innovative service initiative ann-marie marcolin and joyce allen . introduction: with mounting attention for creative and integrated models of c~re .that are populallon and community focused, the healthy child screening initiative achiev.es t~ese pnncipl~s and more! . • parkdale high park rotary (sponsorship) the heal~h ~h1ld scree?1?g is a ~opl~-centred model of care. agency and professional sector-specific silos are ehmmated, ~rov1dmg f~~1hes wit~ one-sto~ access to primary prevention services in a local school gym! children at nsk are rece1vmg early mtervent10n and appropriate referrals to the right care provider, at the right time a~d in t~e right place. further, with a complimentary focus on prevention, the program serves to keep at nsk children healthy. healthy child screening results: the service model is developed around four distinct phases: 1) planned outreach; 2) coordinated intake and registration; 3) interdisciplinary screening; and 4) targeted referral. since the fall 2003 and through six collaborative healthy child screenings 158 children ranging in age from 2 to 6 have benefited from this unique service model of care. conclusion: the presentation will provide practical information on the development and implementation of the model. there will also be a focus on lessons learned in building community service provider-hospital relationships. according to statistics canada (2001) 49% of the toronto population was born outside of canada and 21 % were new immigrants. immigrants often arrive in canada in superior health compared to the canadian born population, but they lose this health advantage over time. changes in immigrant health status over time may be attributed to a variety of factors including barriers to accessing and receiving care as well as limitations in the mainstream health service organizations and their approaches to health care delivery (hyman, 2001 ) . for example, immigrant women are less likely to receive pap tests, which places them at a greater risk for developing cervical cancer. similarly, immigrant women receive less mammography screening than their canadian counterparts. the immigrant women's health centre mobile health unit (mhu) was created as an alternative care delivery model to address the need for increased accessibility as well as culturally and linguistically appropriate reproductive health care. toronto western hospital and the immigrant women's health centre have formed a collaborative partnership which incorporates a primary care nurse practitioner and lay ethnocultural counselors providing care on the mhu. currently, a qualitative ethnonursing study is underway to understand the unique experiences of women using the mhu for their reproductive health care as well as the perspectives of the mhu health care providers. based on a literature review and preliminary findings from provider and participant interviews, the proposed presentation will address the themes of health status for immigrant and refugee women, accessibility issues as well strategies to improve their reproductive health care. we will discuss benefits as well as limitations to health care provision using this alternative service delivery model. michael carden, brian edlin, andrew talal, elizabeth getter, and marla shu lntrod.ction: to date most active drug users have not had access to treatment for hepatitis c virus (hcv) infection and substantial barriers continue to exist that interfere with treatment availability for this population. methods: active illicit drug users interested in pursuing hcv care and treatment were recruited in partnership w~th co~munity-based organizations (cbo's) in new york city. baseline data were collected on quahty of hfe, substance use patterns, depression, health care utilization, hcv health beliefs and other relev.ant variables. medical evaluations were conducted, including liver biopsy when indicated, an~ treatment ts ~ffered when no contraindications are present. participants also receive psychiatric evaluahons to determme the appropriateness of interferon treatment. renlts: fifteen individuals have been recruited to date and received an initial medical evaluation. the mean age was 40 years and _the average age of initial heroin or cocaine use was 16.8. eight (53%) ha~ been homeless at least once m the last 6 months and s (33%) were homeless for most or all of this penod. fourteen (93%) had a history of injection drug use with the mean age at first injection being 21 111s1frsewons v87 ,an. elrven persc.!ns (79%) reported inje~~ng .heroin or cocaine within the last 30 days while the .wing four (21 l'o) reported regular non-m1ect1on use of cocaine and street-obtained benzodiazepines. sijiy seven percent of the sample (n= 10) reported ever being referred to hcv treatment while 2 ( t 3 % ) ftponeddiattreann~nt had been offered by~ ~e.dical provider. none had ever received a liver biopsy or araanent. most believed that hcv was a s1gmf1cant threat to their health (80%) and that there was a pm)dchance they would eventually die if their hepatitis c was not treated (67%). though 7 individuals 147%1 believed that there was no cure for hcv, 13 (87%) reported that they would initiate treatment if i was recommended by their doctor. thirteen (87%) had a current psychiatric diagnosis including «pmsion, anxiety disorder, schizophrenia, schizoaffective disorder, and borderline and antisocial persooaliry disorders. among eight individuals who had the beck depression inventory administered, the mean score was 29.75. attendance rates were 83% (83/100) at scheduled medical and psychiatric 1ppointments and 50% (2/4) at liver biopsy. <andtuions: active drug users, despite experiencing multiple psycho-social problems, can be mgaged in hcv care using a multidisciplinary approach, but require intensive follow-up support. hcv aunnent of active drug users should not be dismissed. n-44 (c) antiretroviral therapy in mv infected infants: when to initiate therapy an african experience kingsley okonkwo, ademola adeyemo, israel sokeye, and nwaife umeike /""°""ction: as technology for early diagnosis of human immunodeficiency virus [hiv] improves, m to commence highly active antiretroviral therapy [haarn is yet to be fully evaluated. this prospective study describes our initial experience with early haart in hiv infected nigerian infants and rqions the outcome. we also analyzed the socioeconomic implications of early haart therapy in infants in the african setting. method: hiv infected infants were started on haart before 6 months and followed up at 4 mkly intervals.we monitored baseline and 3 monthly cd4 . conclusion: initial results suggest early haart before 6 months resulted. in improv~d out~ome in african children. treatment appears to be as effective as in developed counmes. in. a~nca as. m most developing countries with limited resources it is possible and effective to use haart m 1~~ants if p~oper llloniroring facilities are available. however the occurrence of long-term drug related tox1c1ty and mk of emergence of resistant viral strains create need for further evaluation of haart in infants. background: most risk factors for cardiovascular disease (cvd) can be mitigated through ~th clinical interventions and lifestyle change. we used data from a telephone survey of new york city (nyc) adults to characterize health care access and healthy behavior among those with three or more cvd risk factors. methods: the study population included respondents to the nyc community health survey 2002 (n= 9,674) self-reporting~ 3 of the following: smoking, diabetes, high cholesterol level, high blood pres· sure, body mass index >25, and age >45 (males) or >55 (females) (n=2,439). results: based on self-report, an estimated 1.447,000 (24%) of nyc adults have~ 3 or more cvd risk factors. this population is 51 % male, 47% white, 25% black, and 53% with s 12 years of education. most report good access to health care, indicated by having health insurance (95%), regular doctor (89%), their blood pressure checked within last 6 months (91 %), and their choles· terol checked within the past year (90% ). only 29% reported getting at least 20 minutes of exercise ~ 4 times per week and only 9% eating ~ 5 servings of fruits and vegetables the previous day. among current smokers, 59% attempted to quit in past 12 months, but only 32% used medication or counseling. implications: these data suggest that most nyc adults known to be at high risk for cvd have access to regular health care, but most do not engage in healthy lifestyle or, if they smoke, attempt effective quit strategies. more clinic-based and population-level interventions are needed to support lifestyle change among those at high risk of cvd. introduction: recently, much interest has been directed at "obesogenic" (obesity-promoting) (swinburn, egger & raza, 1998) built environments, and at geographic information systems (gis) as a tool for their exploration. a major geographical concept is accessibility, or the ease of moving from an origin to a destination point, which has been recently explored in several health promotion-related stud· ies. there are several methods of calculating accessibility to an urban feature, each with its own strengths, drawbacks and level of precision that can be applied to various health promotion research issues. the purpose of this paper is to describe, compare and contrast four common methods of calculating accessibility to urban amenities in terms of their utility to obesity-related health promotion research. practical and conceptual issues surrounding these methods are introduced and discussed with the intent of providing health promotion researchers with information useful for selecting the most appropria1e accessibility method for their research goal~ ~ethod: this paper describes methodological insights from two studies, both of which assessed the neighbourhood-level accessibility of fast-food establishments in edmonton, canada -one which used a relatively simple coverage method and one which used a more complex minimum cos1 method. res.its: both methods of calculating accessibility revealed similar patterns of high and low access to fast-food outlets. however, a major drawback of both methods is that they assume the characteristics of the a~e~ities and of the populations using them are all the same, and are static. the gravity potential method is introduced as an alternative, since it is ·capable of factoring in measures of quality and choice. a n~mber of conceptual and pr~ctical iss~es, illustrated by the example of situational influences on food choice, make the use of the gravity potential model unwieldy for health promotion research into sociallydetermined conditions such as obesity. co.nclusions: i~ ~ommended that geographical approaches be used in partnership with, or as a foun~ation for, ~admonal exploratory methodologies such as group interviews or other forms of commumty consultation that are more inclusive and representative of the populations of interest. qilhl in los angeles county ,,..ia shaheen, richard casey, fernando cardenas, holman arthurs, and richard baker ~the retinomax autorefractor has been used for vision screening of preschool age childien. ir bas been suggested to be used and test school age children but not been validated in this age poup. ob;taiw: to compare the results of retinomax autorefractor with findings from a comprehensive i!' examination using wet retinoscopy for refractive error. mllhods: children 5-12 years old recruited from elementary schools at los angeles county were iaml with snellen's chart and the retinomax autorefractor and bad comprehensive eye examination with dilation. the proportion of children with abnormal eye examination as well as diesensitiviry and specificity of the screening tools using retinomax autorefractor alone and in combinalion wirh snellen's chart. results of the 258 children enrolled in the study (average age= 8.5± 2.1 years; age range, 5-12 years), 6?% had abnormal eye examination using retinoscopy with dilation. for the lerinomax, the sensitivity was 85% (95% confidence interval [ci] 78%-90%), and the specificity was 31% (95% ci, 22%-41 o/o). simultaneous testing using snellen's chart and retinomax resulted in gain in 111sitiviry (94%, 95% cl= 89, 97), and loss in specificity (28%, 95% cl= 19%-38%). the study showed that screening school age children with retinomax autorefractor could identify most cases with abnormal vision but would be associated with many false-positive results. simuhaneous resting using snellen's chart and retinomax maximize the case finding but with very low specificiry. mdhotjs: a language-stratified, random sample of 2366 members of the college of family physicians of canada received a confidential survey. the questionnaire collected data on socio-demographic characteristics, medical training, practice type, setting and hcv-related care practices. the self-adminisratd questionnaire was also made available to participants for completion on the internet. batdti: response proportion was 33%. median age was 41 years (47% female) and the proporlionoffrench questionnaires was 26%. approximately 88% had completed family medicine residency lllining in canada; median year of training completion was 1995. sixty-seven percent, 38% and 29% work in private offices/clinics, community hospitals and emergency departments, respectively. regarding ~practices, 94% had ever requested a hcv test and 87% of physicians had screened for hcv iafrction in rhe past 12 months· median number of tests was 10. while 17% reported having no hcv-uaed patients in their practic~, 44% had 1-5 hcv-infected patients. regarding the level of hcv care provided, 4.3% provide ongoing advanced hcv care including treatment and dose monitoring for ctmduions: in this sample of canadian family physicians, most had pro~ided hcv screening. to •least one patient in the past year. less than half had 1-5 hcv-infected patients and 41 % provide ~:relared care the role of socio-demographic factors, medical training as wel_i as hcv ca~e percep-lldas 10 rhe provision of appropriate hcv screening will be examined and described at the time of the canference. '4-50 (c) healthcare services: the context of nepal meen poudyal chhetri """1tl.ction healthcare service is related with the human rights and fundamental righ~ of the ci~ ciaaiuntry. however, the growing demand foi health care services, quality heal~care service, accessib1b~ id die mass population and paucity of funds are the different but interrelated issues to .be ~ddressed. m nepat.1n view of this context, public health sector in nepal is among other sectors, which is struggling -.i for scarce resources. . . . nepal, the problems in the field of healthcare servic~s do not bnut ~o the. paucity of faads and resources only, but there are other problems like: rural -urban imbalance, regional unbalance, poster sessio~ f the ll ·m1 ·ted resources poor healthcare services, inequity and inaccessibility of the poor management o , . poor people of the rural, remote and hilly areas for the healthcare services and so on.. . . . · . i f ct the best resource allocation is the one that max1m1zes t e sum o m ivi ua s u11 · ea t services. n a , · h d' ·b · · · h . ·t effi.ciency and efficient management are correlated. it might be t e re istn utmn of mes. ence, equi y, . . . . 1 . income or redistribution of services. moreover, maximizanon of available resources, qua tty healthcare services and efficient management of them are the very important and necessary tools and techmques to meet the growing demand and quality healthcare services in nepal. p4-51 (a) an jn-depth analysis of medical detox clients to assist in evidence based decision making xin li, huiying sun, ajay puri, david marsh, and aslam anis introduction: problematic substance use represents an ever-increasing public health challenge. in the vancouver coastal health (vch) region, there are more than 100,000 individuals having some probability of drug or alcohol dependence. to accommodate this potential demand for addiction related services, vch provides various services and treatment, including four levels of withdrawal management services (wms). clients seeking wms are screened and referred to appropriate services through a central telephone intake service (access i). the present study seeks to rigorously evaluate one of the services, vancouver detox, a medically monitored 24-bed residential detox facility, and its clients. doing so will allow decision makers to utilize evidence based decision-making in order to improve the accessibility and efficiency of wms, and therefore, the health of these clients. methods: we extract one-year data (october 1, 2003 -september 30, 2004 from an efficient and comprehensive database. the occupancy rate of the detox centre along with the clients' wait time for service and length of stay (los) are calculated. in addition, the effect of seasonality on these variables and the impact of the once per month welfare check issuance on the occupancy rate are also evaluated. results: among the 2411 clients (median age 40, 65% male) who were referred by access! to vancouver detox over the one-year period, 1448 were admitted. the majority (81 %) of those who are not admitted are either lost to follow up (i.e., clients not having a fixed address or telephone) or declined service at time of callback. the median wait time was 1 day [q3-ql: 3-1], the median los was 5 days iq3-qt: 6-3], and the average bed occupancy rate was 83%. however, during the threeday welfare check issue period the occupancy rate was lower compared to the other days of the year 175% vs. 84%, p conclusion: our analysis indicates that there was a relatively short wait time at vancouver detox, however 40% of the potential clients were not served. in addition, the occupancy rate declined during the welfare check issuance period and during the summer. this suggests that accessibility and efficiency at vancouver detox could be improved by specifically addressing these factors. background: intimate partner violence (ipv) is associated with acute and chronic physical and men· tal health outcomes for women resulting in greater use of health services. yet, a vast literature attests to cultural variations in perceptions of health and help-seeking behaviour. fewer studies have examined differences in perceptions of ipv among women from ethnocultural communities. the recognition, definition, and understanding of ipv, as well as the language used to describe these experiences, may be different in these communities. as such, a woman's response, including whether or not to disclose or seek help, may vary according to her understanding of the problem. methods: this pilot study explores the influence of cultural factors on perceptions of and responses to ipv among canadian born and immigrant young women. in-depth focus group interviews were con· ducted with women, aged 18 to 24 years, living in toronto. open-ended and semi-structured interview questions were designed to elicit information regarding how young women socially construct jpv and where they would go to receive help. interviews were transcribed, then read and independently coded by the research team. codes were compared and disagreements resolved. qualitative software qsr n6 was used to assist with data management. . ruu~ts_: res~nses_abo~t what constitutes ipv were similar across the study groups. when considering specific ab.us1ve ~1tuanons and types of relationships, participants held fairly relativistic views about ipv, especially with regard to help-seeking behaviour. cultural differences in beliefs about normaive m;ile/femal~ relations. familial.roles, and customs governing acceptable behaviours influenced partictpants perceptions about what 1n1ght be helpful to abused women. interview data highlight the social l05ter srnfons v91 11111 suucrural _impact these factors ha:e on you?g women and provide details regarding the dynamics of cibnocultur~ m~uences on help-~eekmg behav10ur: t~e ro~e of such factors such as gender inequality within rtlaoo?sh1ps and t_he ~erce1ved degree of ~oc1al 1solat1on and support nerworks are highlighted. collc~ the~ findmgs unde~score the _1mporta_nc_e of understanding cultural variations in percrprions of ipv ~ relanon to ~elp-seekmg beha~1':'ur. th1s_mformation is critical for health professionals iodiey may connnue developmg culturally sensmve practices, including screening guidelines and protorol s. ln addition, _this study demonstr~tes that focus group interviews are valuable for engaging young romen in discussions about ipv, helpmg them to 'name' their experiences, and consider sources of help when warranted. p4-s3 (a) health problems and health care use of young drug users in amsterdam .wieke krol, evelien van geffen, angela buchholz, esther welp, erik van ameijden, and maria prins /11trod11ction: recent advances in health care and drug treatment have improved the health of populations with special social and health care needs, such as drug users. however, still a substantial number dots not have access to the type of services required to improve their health status. in the netherlands, tspccially young adult drug users (yad) whose primary drug is cocaine might have limited access to drugrreatment services. in this study we examined the history and current use of (drug associated) treatmmt services, the determinants for loss of contact, and the current health care needs in the young drug mm amsterdam study (yodam). methods: yodam started in 2000 and is embedded in the amsterdam cohort study among drug mm. data were derived from y ad aged < 30 years who had used cocaine, heroin, ampheramines and i or methadone at least 3 days a week during the 2 months prior to enrolment. res11lts:of 195 yao, median age was 27 years (range: 18-30 years), 72% was male and 83% had 1dutch nationality at enrolment. nearly all participants (97%) reported a history of contact with drug llt.lnnent services (methadone maintenance, rehabilitation clinics and judicial treatment), mental health car? (ambulant mental care and psychiatric hospital) or general treatment services (day-care, night-care, hdp for living arrangements, work and finance). however, only 61 % reported contact in the past six l!xlllths. this figure was similar in the first and second follow-up visit. among y ad who reported no current contact with the health care system, 87% would like to have contact with general treatment serl' icts. among participants who have never had contact with drug treatment services, 67% used primarily cocaine compared with 22% and 8% among those who reported past or current contact, respectively. saied on the addiction severity index, 70% reported at least one mental health problem in the past 30 days, but only 11 % had current contact with mental health services. concl11sion: results from this study among young adult drug users show that despite a high contact rm with health care providers, the health care system seems to lose contact with yao. since 87% indicatt the need of general treatment services, especially for arranging house and living conditions, health m services that effectively integrate general health care with drug treatment services and mental health care might be more successful to keep contact with young cocaine users. mtthods: respondents included adults aged 18 and over who met dsm-iv diagn?snc criteria for an anxiety or depressive disorder in the past 12 months. we performed two sets of logisnc regressmns. thtdichotomous dependent variables for each of the regressions indicated whether rhe respondenr_vis-ud a psychiatrist, psychologist, family physician or social worker in the _past_ 12 months. no relationship for income. there was no significant interaction between educatmn an mco~:· r: ::or respondents with at least a high school education to seek help ~rom any of the four servic p were almost twice that for respondents who had not completed high school. th . d ec of analyses found che associacion becween educacion and use of md-provided care e secon s · · be d · · ·f· ly 1 ·n che low income group for non-md care, the assoc1anon cween e ucatlon and was s1gm icant on -· . . . . use of social workers was significant in both income groups, but significant only for use of psychologists in che high-income group. . . . conclusion: we found differences in healch service use by education level. ind1v1duals who have nor compleced high school appeared co use less mental he~lt~ servi~es provided ~y psyc~iatrists, psycholo· gists, family physicians and social workers. we found limited e.v1dence _suggesting the influence of educa· tion on service use varies according to income and type of service provider. results suggesc there may be a need to develop and evaluate progr~ms.designe~ to deliver targeted services to consumers who have noc completed high school. further quahtanve studies about the expen· ence of individuals with low education are needed to clarify whether education's relationship with ser· vice use is provider or consumer driven, and to disentangle the interrelated influences of income and education. system for homeless, hiv-infected patients in nyc? nancy sahler, chinazo cunningham, and kathryn anastos introduction: racial/ethnic disparities in access to health care have been consistently documented. one potential reason for disparities is that the cultural distance between minority patients and their providers discourage chese patients from seeking and continuing care. many institucions have incorporated cultural compecency craining and culturally sensicive models of health care delivery, hoping co encourage better relacionships becween patients and providers, more posicive views about the health care system, and, ulcimacely, improved health outcomes for minority patients. the current scudy tests whether cultural distance between physicians and patients, measured by racial discordance, predicts poorer patient attitudes about their providers and the health care system in a severely disadvantaged hiv-infected population in new york city that typically reports inconsistent patterns of health care. methods: we collected data from 396 unscably housed black and latino/a people with hiv who reported having a regular health care provider. we asked them to report on their attitudes about their provider and the health care system using validated instruments. subjects were categorized as being racially "concordant" or "discordant" with their providers, and attitudes of these two groups were compared. results: the sample consisted of 256 (65%) black and 140 (35%) latino/a people, who reported having 80 (20%) black physicians, 49 (12%) latino/a physicians, 167 (42%) white physicians, and 100 (25%) physicians of another/unknown race/ethnicity. overall, 260 (75%) subjects had physicians of a different race/ethnicity than their own. racial discordance did not predict negative attitudes about rela· tionship with providers: the mean rating of a i-item trust in provider scale (lo=high and o=low) was 8.0 for both concordant and discordant groups, and the mean score in 13-icem relationship with provider scale (4=high and !=low) was 3.5 for both groups. however discordance was significantly associated with distrust in che health care syscem: che mean score on a 7-icem scale (5=high discrust and l=low distrust) was 3.4 for discordant group and 3.0 for che concordant group (t= 2.66, p= 0.008). we further explored these patterns separacely in black and lacino/a subgroups, and using different strategies ro conceptualize racial/ethic discordance. conclusions: in this sample of unscably housed black and latino/a people who receive hiv care in new york city, having a physician from the same racial/ethnic background may be less important for developing a positive doctor-patient relationship than for helping the patients to dispel fear and distrust about the health care system as a whole. we discuss the policy implications of these findings. ilene hyman and samuel noh . .abstract objectiw: this study examines patterns of mental healthcare utilization among ethiopian 1mm1grants living in toronto. methods: a probability sample of 342 ethiopian adults ( 18 years and older) completed structured face-to-face interviews. variables ... define, especially who are non-health care providers. plan of analysis. results: approximately 5% of respondents received memal health services from mainstream healthcare providers and 8% consulted non-healthcare professionals. of those who sought mental health services from mainstream healthcare providers, 3.1 % saw family physicians, 2.1 % visited a psychiatrist. and 0.6% consulted other healthcare providers. compared with males, a significantly higher proportion 1gsfer sessions v93 ri ftlnales consulted non-healthcare_ professionals for emotional or mental health problems (p< 0.01 ). tlbile ethiopian's overall use of mamstream healthcare services for emotional problems (5%) did not prlydiffer from the rate (6%) of the general population of ontario, only a small proportion ( 12.5%) rjerhiopians with mental health needs used services from mainstream healthcare providers. of these, !oj% received family physicians' services, 4.3 % visited a psychiatrist, and 2.2% consulted other healthll/c providers. our data also suggested that ethiopian immigrants were more likely to consult tradioooal healers than health professionals for emotional or mental health problems ( 18.8% vs. 12.5% ). our bivariate analyses found the number of somatic symptoms and stressful life events to be associated with an increased use of medical services and the presence of a mental disorder to be associated with a dfcreased use of medical services for emotional problems. however, using multivariate methods, only die number of somatic symptoms remained significantly associated with use of medical services for emooonal problems. diu#ssion: study findings suggest that there is a need for ethnic-specific and culturally-appropriate mrcrvention programs to help ethiopian immigrants and refugees with mental health needs. since there ~a strong association between somatic symptoms and the use family physicians' services, there appears robe a critical role for community-based family physicians to detect potential mental health problems among their ethiopian patients, and to provide appropriate treatment and/or referral. the authors acknowledge the centre of excellence for research in immigration and settlement (ceris) in toronto and canadian heritage who provided funding for the study. we also acknowledge linn clark whose editorial work has improved significantly the quality of this manuscript. we want to thank all the participants of the study, and the ethiopian community leaders without whose honest contributions the present study would have not been possible. this paper addresses the impact of the rationalization of health-care services on the clinical decision-making of emergency physicians in two urban hospital emergency departments in atlantic canada. using the combined strategies of observational analysis and in-depth interviewing, this study provides a qualitative understanding of how physicians and, by extension, patients are impacred by the increasing ancmpts to make health-care both more efficient and cost-effective. such attempts have resulted in significantly compromised access to primary care within the community. as a consequence, patients are, out of necessity, inappropriately relying upon emergency departments for primary care services as well as access to specialty services. within the hospital, rationalization has resulted in bed closures and severely rmricted access to in-patient services. emergency physicians and their patients are in a tenuous position having many needs but few resources. furthermore, in response to demands for greater accountability, physicians have also adopted rationality in the form of evidence-based medicine. ultimately, ho~ever, rationality whether imposed upon, or adopted by, the profession significantly undermines physu.:1ans' ability to make decisions in the best interests of their patients. johnjasek, gretchen van wye, and bonnie kerker introduction: hispanics comprise an increasing proportion of th.e new york city (nyc) populanon !currently about 25%). like males in the general population, h1spamc males (hm) have a lower prrval,nce of healthcare utilization than females. however, they face additional access barriers such as bnguage differences and high rates of uninsurance. they also bear a heavy burden of health problems lllehasobesity and hiv/aids. this paper examines patterns of healthcare access and ut1hzat1on by hm compared to other nyc adults and identifies key areas for intervention. . . . 148 9 01 5 8 9 01 and older are significantly lower than the nhm popu anon . 10 v. . 10, p<.05), though hi\' screening and immunizations are comparable between the two groups. conclusion: findings suggest that hm have less access t? healthcare than hf or nhm. hown1r, hm ble to obtain certain discrete medical services as easily as other groups, perhapsdueto!rtor are a hm. i i . subsidized programs. for other services, utilization among 1s ower. mprovmg acc~tocareinthis group will help ensure routine, quality care, which can lead to a greater use of prevennve services iii! thus bener health outcomes. introduction: cancer registry is considered as one of the most important issues in cancer epidemiology and prevention. bias or under-reporting of cancer cases can affect the accuracy of the results of epidemiological studies and control programs. the aim of this study was to assess the reliability of the regional cancer report in a relatively small province (yasuj) with almost all facilities needed for c3llcll diagnosis and treatment. methods: finding the total number of cancer cases we reviewed records of all patients diagnoicd with cancer (icd 140-239) and registered in any hospital or pathology centre from1999 until 2001 i n yasuj and all (5) surrounding provinces. results: of 504 patients who were originally residents of yasui province, 43.7% wereaccoulll!d for yasuj province. the proportion varies according to the type of cancer, for exarnplecancetsofdiglstive system, skin and breast were more frequently reported by yasuj's health facilities whereas cancmoi blood, brain and bone were mostly reported by neighbouring provinces. the remaining cases (56.3%1 were diagnosed, treated and recorded by neighbouring provinces as their incident cases. this is partly because of the fact that patients seek medical services from other provinces as they believed that the facil. ities are offered by more experienced and higher quality stuffs and their relative's or temporary acooiii' modation addresses were reported as their place of residence. conclusion: measuring the spatial incidence of cancer according to the location of report ortht current address affected the spatial statistics of cancer. to correct this problem recording the permanm! address of diagnosed cases is important. p4-60 (c). providing primary healthcare to a disadvantaged population at a university-run commumty healthcare facility tracey rickards the. c:ommuni~y .h~alth ~linic (chc) is a university sponsored nurse-managed primary bealthwt (p~c:l clime. the clm1c is an innovative model of healthcare delivery in canada that has integrated tht principles of phc ser · · h' . vices wit ma community development framework. it serves to provide access to phc services for members of th · · illi · dru is ii be . . e community, particularly the poor and those who use or gs, we mg a service-learning facil'ty f d · · · · · · d rionll h . . .,m.:. · t · . meet c ient nee s. chmc nursing and social work staff and srudents r·--· ipa em various phc activities and h .l.hont" less i . f . outreac services in the local shelters and on the streels to'"" popu auon o fredericton as well th chc · model iii fosterin an on oi : . • e promotes and supports a harm reduction . · local d!or an~ h ng ~art:ersh1p with aids new brunswick and their needle exchange program, w1tha ing condoms and :xu:t h:~~~e e~aint~nance therapy clients, and with the clie~ts themselves ~_r; benefits of receiving health f ucation, a place to shower, and a small clothing and food oai~· care rom a nurse p · · d d · --""~'i"· are evidenced in th r research that involved needsaans mvo ves clients, staff, and students. to date the chc has unacn-1 · sessment/enviro i . d ; •• '""""1ll eva uanon. the clinic has also e . d nmenta scan, cost-benefit analysis, an on-go...,,1"".'i'~ facility and compassionate lea x~mme the model of care delivery' focusing on nursing roles wi~ cj rmng among students. finally, the clinic strives to share the resu•p v95 . -arch with the community in which it provides service by distributing a bi-monthly newsletter, and plllicipating in in-services and educational sessions in a variety of situations. the plan for the future is coolinued research and the use of evidence-based practice in order to guide the staff in choosing how much n~ primary healthcare services to marginalized populations will be provided. n-61 (c) tuming up the volume: marginalized women's health concerns tckla hendrickson and betty jane richmond bdrotbu:tion: the marginalization of urban women due to socio-economic status and other determinants negatively affects their health and that of their families. this undermines the overall vitaliry of urban communities. for example, regarding access to primary health care, women of lower economic surus and education levels are less likely to be screened for breast and cervical cancer. what is not as widely reported is how marginalized urban women in ontario understand and articulate their lack of access to health care, how they attribute this, and the solutions that they offer. this paper reports on the rnults of the ontario women's health network (owhn) focus group project highlighting urban women's concerns and suggestions regarding access to health care. it also raises larger issues about urban health, dual-purpose focus group design, community-based research and health planning processes. mdhods: focus group methodology was used to facilitate a total of 30 discussions with 55 urban and 54 rural women across ontario from 2003 to 2005. the women were invited to participate by local women's and health agencies and represented a range of ages, incomes, and access issues. discussions focussed on women's current health concerns, access to health care, and information needs. results were analyzed using grounded theory. the focus groups departed from traditional focus group research goals and had two purposes: 1) data collection and dissemination (representation of women's voices), and 2) fostering closer social ties between women, local agencies, and owhn. the paper provides a discussion and rationale for a dual approach. rax/ts: the results confirm current research on women's health access in women's own voices: urban women report difficulty finding responsive doctors, accessing helpful information such as visual aids in doctors' offices, and prohibitive prescription costs, in contrast with rural women's key concern of finding a family doctor. the research suggests that women's health focus groups can address access issues by helping women to network and initiate collective solutions. the study shows that marginalized urban women are articulate about their health conctrns and those of their families, often understanding them in larger socio-economic frameworks; howtver, women need greater access to primary care and women-friendly information in more languages and in places that they go for other purposes. it is crucial that urban health planning processes consult directly with women as key health care managers, and turn up the volume on marginalized women's voices. women: an evaluation of awareness, attitudes and beliefs introduction: nigeria has one of the highest rates of human immunodeficiency virus ihivi seroprrvalence in the world. as in most developing countries vertical transmission from mother to child account for most hiv infection in nigerian children. the purpose of this study was ro. determine the awareness, attitudes and beliefs of pregnant nigerian women towards voluntary counseling and testing ivct! for hiv. mnbod: a pre-tested questionnaire was used to survey a cross section '.>f.240 pregnant women ~t 2 (lrlleral antenatal clinics in awka, nigeria. data was reviewed based on willingness to ~c~ept or re1ect vct and the reasons for disapproval. knowledge of hiv infection, routes of hiv transm1ssmn and ant1rnroviral therapy iart) was evaluated. hsults: 72% of the women had good knowledge of hiv, i 5% had fair knowledge while 1.1% had poor knowledge of hiv infection.48% of the women were not aware of the association of hreast milk feeding and transmission of hiv to their babies. majority of the women 87% approved v~t while 13% disapproved vct, 93% of those who approved said it was because vct could ~educe risk of rransmission of hiv to their babies. all respondents, 100% who accepted vc.i ~ere willing to be tnted if results are kept confidential only 23% accepted to be tested if vc.t results w.111 be s~ared w1.th pinner and relatives 31 % attributed their refusal to the effect it may have on their marriage whale 69 '-gave the social 'and cultural stigmatization associated with hiv infection for their r~fusal.s 9 % wall accept vct if they will be tested at the same time with their partners.81 ~0 of ~omen wall pref~r to breast feed even if they tested positive to hiv. women with a higher education diploma were 3 times v96 more likely to accept vct. knowledge of art for hiv infected pregnant women as a means of pre. vention of maternal to child transmission [pmtct) was generally poor, 37% of respondents wm aware of art in pregnancy. conclusion: the acceptance of vct by pregnant women seems to depend on their understanding that vct has proven benefits for their unborn child. socio-cultur al factors such as stigmatizationof hiv positive individuals appears to be the maj_or impedi~ent towards widespread acceptanee of ycr in nigeria. involvemen t of male partners may 1mpro~e attitudes t~wa~ds vct:the developmentofm novative health education strategies is essential to provide women with mformanon as regards the benefits of vct and other means of pmtct. p4-63 (c) ethnic health care advisors in information centers on health care and welfare in four districts of amsterdam arlette hesselink, karien stronks, and arnoud verhoeff introduction : in amsterdam, migrants report a "worse actual health and a lower use of health care services than the native dutch population. this difference might be partly caused by problems migrants have with the dutch language and health care and welfare system. to support migrants finding their way through this system, in four districts in amsterdam information centers on health care and welfare were developed in which ethnic health care advisors were employed. their main task is to provide infor· mation to individuals or groups in order to bridge the gap between migrants and health care providers. methods: the implementat ion of the centers is evaluated using a process evaluation in order to give inside in the factors hampering and promoting the implementat ion. information is gathered using reports, attending meetings of local steering groups, and by semi-structu red interviews with persons (in)directly involved in the implementat ion of the centers. in addition, all individual and groupcontaets of the health care advisors are registered extensively. results: since 2003 four information centers, employing 12 ethnic health care advisors, are implemented. the ethnicity of the health care advisors corresponds to the main migrant groups in the different districts (e.g. moroccan, turkeys, surinamese and african). depending on the local steering groups, the focus of the activities of the health care advisors in the centers varies. in total, around 2000 individual and 225 group educational sessions have been registered since the start. most participants were positive about the individual and group sessions. the number of clients and type of questions asked depend highly on the location of the centers (e.g. as part of a welfare centre or as part of a housing corporation). in all districts implementa tion was hampered by lack of ongoing commitment of parties involved (e.g. health care providers, migrant organization s) and lack of integration with existing health care and welfare facilities. discussion: the migrant health advisors seem to have an important role in providing information on health and welfare to migrant clients, and therefore contribute in bridging the gap between migrants and professionals in health care and welfare. however, the lack of integration of the centers with the existing health care and welfare facilities in the different districts hampers further implementation . therefore, in most districts the information centres will be closed down as independent facilicities in the near future, and efforts are made to better connect the position of migrant health advisor in existing facilities. the 2005 who report ranks the philippines as ninth among 22 countries with a high tb prevalence. about a fourth of the country's population is infected, with majority of cases coming from the lower socioeconomic segments of the community. metro manila is not only the economic and political capital of the philippines but also the site of major universities and educational institutions. initial interviews with the school's clinicians have established the need to come up with treatment guidelines and protocols for students and personnel when tb is diagnosed. these cases are often identified during annual physical examinations as part of the school's requirements. in many instances, students and personnel diagnosed with tb are referred to private physicians where they are often lost to follow-up and may have failure of treatment due to un monitored self-administered therapy. this practice ignores the school clinic's great potential as a tb treatment partner. through its single practice network (spn) initiative, the philippine tuberculosis initiatives for the private sector (philippine tips), has established a model wherein school clinics serve as satellite treatment partners of larger clinics in the delivery of the directly observed treatment, short course (dots) protocol. this "treatment at the source" allows school-based patients to get their free government-suppl ied tb medicines from the clinic each day. it also cancels out the difficulty in accessing medicines through the old model where the patient has to go to the larger clinic outside his/her school to get treatment. the model also enables the clinic to monitor the treatment progress of the student and assumes more responsibility over their health. this experience illustrates how social justice in health could be achieved from means other than fund generation. the harnessing of existing health service providers in urban communities through standardized models of treatment delivery increases the probability of treatment success, not only for tb but for other conditions as well. p4-66 (c) voices for vulnerable populations: communalities across cbpr using qualitative methods martha ann carey, aja lesh, jo-ellen asbury, and mickey smith introduction: providing an opportunity to include, in all stages of health studies, the perspectives and experiences of vulnerable and marginalized populations is increasingly being recognized as a necessary component in uncovering new solutions to issues in health care. qualitative methods, especially focus groups, have been used to understand the perspectives and needs of community members and clinical staff in the development of program theory, process evaluation and refinement of interventions, and for understanding and interpreting results. however, little guidance is available for the optimal use of such information. methods: this presentation will draw on diverse experiences with children and their families in an asthma program in california, a preschool latino population in southern california, a small city afterschool prevention program for children in ohio, hiv/aids military personnel across all branches of the service in the united states, and methadone clinic clients in the south bronx in new york city. focus groups were used to elicit information from community members who would not usually have input into problem definitions and solutions. using a fairly common approach, thematic analysis as adapted from grounded theory, was used to identify concerns in each study. next we looked across these studies, in a meta-synthesis approach, to examine communalities in what was learned and in how information was used in program development and refinement. results: while the purposes and populations were diverse, and the type of concerns and the reporting of results varied, the conceptual framework that guided the planning and implementation of each study was similar, which led to a similar data analysis approach. we will briefly present the results of each study, and in more depth we will describe the communalities and how they were generated. conclusions: while some useful guidance for planning future studies of community based research was gained by looking across these diverse studies, it would be useful to pursue a broader examination of the range of populations and purposes to more fully develop guidance. background: the majority of studies examining the relationship between residential environments and cardiovascular disease have used census derived measures of neighborhood ses. there is a need to identify specific features of neighborhoods relevant to cardiovascular disease risk. we aim to 1) develop methods· data on neighborhood conditions were collected from a telephone survey of s,988 fesi· dents in balth:.ore, md; forsyth county, nc; and new york, ny. a sample of 120 of the i.ni~~l l'elpondents was re-interviewed 2-3 weeks after the initial interview t~ measure the tes~-~etest rebab1~1ty of ~e neighborhood scales. information was collected across seven ~e1ghborho~ cond1~ons (aesth~~ ~uah~, walking environment, availability of healthy foods, safety, violence, social cohesion, and acnvmes with neighbors). neighborhoods were defined as census tracts or homogen~us census tra~ clusters. ~sycho metric properties.of the neighborhood scales were accessed by ca~cu~~.ng chronba~h s alpha~ (mtemal consistency) and intraclass correlation coefficients (test-r~test reliabilmes) .. pear~n s .corre~anons were calculated to test for associations between indicators of neighborhood ses (tncludmg d1mens1ons of race/ ethnic composition, family structure, housing, area crowding, residential stability, education, employment, occupation, and income/wealth) and our seven neighborhood scales. . chronbach's alphas ranged from .73 (walking environment) to .83 (violence). intraclass correlations ranged from .60 (waling environment) to .88 (safety) and wer~ high~~~ .7~ for ~urout of the seven neighborhood dimensions. our neighborhood scales (excluding achv1hes with neighbors) were consistently correlated with commonly used census derived indicators of neighborhood ses. the results suggest that neighborhood attributes can be reliably measured. further development of such scales will improve our understanding of neighborhood conditions and their importance to health. childhood to young adulthood in a national u.s. sample jen jen chang lntrodfldion: prior studies indicate higher risk of substance use in children of depressed mothers, but no prior studies have followed up the offspring from childhood into adulthood to obtain more precise estimates of risk. this study aimed to examine the association between early exposure to maternal depl'elsive symptoms (mds) and offspring substance use across time in childhood, adolescence, and young adulthood. methods: data were obtained from the national longitudinal survey of youth. the study sample includes 4,898 mother-child/young adult dyads interviewed biennially between 1992 and 2002 with children aged 4 to 16 years old at baseline. data were gathered using a computer-assisted personal interview method. mds were measured in 1992 using the center for epidemiologic studies depression scale. offspring substance use was assessed biennially between 1994 and 2002. logistic and passion regression models with generalized estimation equation approach was used for parameter estimates to account for possible correlations among repeated measures in a longitudinal study. rnlllta: most mothers in the study sample were whites (42%), urban residents (79%), had a mean age of 31 years with at least a high school degree (82%). the mean child age at baseline was 9 years old. offspring cigarette and alcohol use increased monotonically across childhood, adolescence, and young adulthood. differential risk of substance use by gender was observed. early exposure to mds was associated with increased risk of cigarette (adjusted odds ratio (aor) = 1.52, 95% confidence interval (0): 1.12, 2.08) and marijuana use (aor = 1.46, 95% ci: 1.02, 2.08), but not with alcohol use across childhood, adolescence, and young adulthood, controlling for a child's characteristics, socioeconomic status, ~ligiosity, maternal drug use, and father's involvement. among the covariates, higher levels of father's mvolvement condluion: results from this study confirm previous suggestions that maternal depressive symptoms are associated with adverse child development. findings from the present study on early life experi-e~ce have the potential to inform valuable prevention programs for problem substance use before disturbances become severe and therefore, typically, much more difficult to ameliorate effectively. the ~act (~r-city men~ health study predicting filv/aids, club and other drug transi-b~) study 15 a multi-level study aimed at determining the association between features of the urban enyjronment mental health, drug use, and risky sexual behaviors. the study is randomly sampling foster sessions v99 neighborhood residents and assessing the relations between characteristics of 36 ethnographically defined urban neighborhoods and the health outcomes of interest. a limitation of existing systematic methods for evaluating the physical and social environments of urban neighborhoods is that they are expensive and time-consuming, therefore limiting the number of times such assessments can be conducted. this is particularly problematic for multi-year studies, where neighborhoods may change as a result of seasonality, gentrification, municipal projects, immigration and the like. therefore, we developed a simpler neighborhood assessment scale that systematically assessed the physical and social environment of urban neighborhoods. the impact neighborhood evaluation scale was developed based on existing and validated instruments, including the new york city housing and vacancy survey which is performed by the u.s. census bureau, and the nyc mayor's office of operations scorecard cleanliness program, and modified through pilot testing and cognitive testing with neighborhood residents. aspects of the physical environment assessed in the scale included physical decay, vacancy and construction, municipal investment and green space. aspects of the social environment measured include social disorder, social trust, affluence and formal and informal street economy. the scale assesses features of the neighborhood environment that are determined by personal (e.g., presence of dog feces), community (e.g., presence of a community garden), and municipal (e.g., street cleanliness) factors. the scale is administered systematically block-by-block in a neighborhood. trained research staff start at the northeast corner of an intersection and walk around the blocks in a clockwise direction. staff complete the scale for each street of the block, only evaluating the right side of the street. thus for each block, three or more assessments are completed. we are in the process of assessing psychometric properties of the instrument, including inter-rater reliability and internal consistency, and determining the minimum number of blocks or street segments that need to be assessed in order to provide an accurate estimate of the neighborhood environment. these data will be presented at the conference. obj«tive: to describe and analyze the perceptions of longterm injection drug users (idus) about their initiation into injecting. toronto. purposive sampling was used to seek out an ethnoculturally diverse sample of idus of both genders and from all areas of the city, through recruitment from harm reduction services and from referral by other study participants. interviews asked about drug use history including first use and first injecting, as well as questions about health issues, service utilization and needs. thematic analysis was used to examine initiation of drug use and of injection. results: two conditions appeared necessary for initiation of injection. one was a developed conception of drugs and their (desirable) effects, as suggested by the work of becker for marijuana. thus virtually all panicipants had used drugs by other routes prior to injecting, and had developed expectations about effects they considered pleasureable or beneficial. the second condition was a group and social context in which such use arose. no participants perceived their initiation to injecting as involving peer pressure. rather they suggested that they sought out peers with a similar social situation and interest in using drugs. observing injection by others often served as a means to initiate injection. injection served symbolic purposes for some participants, enhancing their status in their group and marking a transition to a different social world. concl111ion: better understanding of social and contextual factors motivating drug users who initiate injection can assist in prevention efforts. 10 ma!onty of them had higher educational level (57%-highschool or higher).about 20.2 yo adffiltted to have history of alcohol & another 12.4% had history of smoking. only 3.2% people were on hrt & 3.1 % were receiving steroid. majority of them (81.2) did not have history of osteoporosis. 13.6% have difficulty in ambulating. only 8.8% had family history of osteoporosis. bmd measurements as me~sured by dual xray absorptiometry (dexa) were used for the analysis. bmd results were compare~ w1~ rbc folate & serum vitamin b12 levels. no statistical significance found between bmd & serum v1taffiln b12 level but high levels of folate level is associated with normal bmd in bivariate and multivariate analysis. conclusion: in the studied elderly population, there was no relationship between bmd and vitamin b12; but there was a significant association between folate levels & bmd. introduction: adolescence is a critical period for identity formation. western studies have investigated the relationship of identity to adolescent well-being. special emphasis has been placed on the influence of ethnic identity on health, especially among forced migrants in different foreign countries. methodology: this study asses by the means of an open ended question identity categorization among youth in three economically disadvantaged urban communities in beirut, the capital of lebanon. these three communities have different histories of displacement and different socio-demographic makeup. however, they share a history of displacement due to war. results and conclusion: the results indicated that nationality was the major category of identification in all three communities followed by origin and religion. however, the percentages that self-identify by particular identity categories were significantly different among youth in the three communities, perhaps reflecting different context in which they have grown up. mechanical heart valve replacement amanda hu, chi-ming chow, diem dao, lee errett, and mary keith introduction: patients with mechanical heart valves must follow lifelong warfarin therapy. war· farin, however, is a difficult drug to take because it has a narrow therapeutic window with potential seri· ous side effects. successful anticoagulation therapy is dependent upon the patient's knowledge of this drug; however, little is known regarding the determinants of such knowledge. the purpose of this study was to determine the influence of socioeconomic status on patients' knowledge of warfarin therapy. methods: a telephone survey was conducted among 100 patients 3 to 6 months following mechan· ical heart valve replacement. a previously validated 20-item questionnaire was used to measure the patient's knowledge of warfarin, its side effects, and vitamin k food sources. demographic information, socioeconomic status data, and medical education information were also collected. results: sixty-one percent of participants had scores indicative of insufficient knowledge of warfarin therapy (score :s; 80%). age was negatively related to warfarin knowledge scores (r= 0.27, p = 0.007). in univariate analysis, patients with family incomes greater than $25,000, who had greater. than a grade 8 education and who were employed or self employed had significantly higher warfarm knowledge scores (p= 0.007, p= 0.002 and p= 0.001 respectively). gender, ethnicity, and warfar~n therapy prior to surgery were not related to warfarin knowledge scores. furthermore, none of t~e. m-hospital tea~hing practices significantly influenced warfarin knowledge scores. however, panic1~ants who _rece1v~d post discharge co~unity counseling had significantly higher knowledge scores tn comp~r1son with those who did not (p= 0.001 ). multivariate regression analysis revealed that und~r~tandmg the ~oncept of 1?ternational normalized ratio (inr), knowing the acronym, age and receiving ~ommum1!' counseling after discharge were the strongest predictors of warfarin kn~wledge. s~1oeconom1c status was not an important predictor of knowledge scores on the multivanate analysis. poster sessions v101 ~the majority of patients at our institution have insufficient knowledge of warfarin therapy.post-discharge counseling, not socioeconomic status, was found to be an important predictor of warfarin knowledge. since improved knowledge has been associated with improved compliance and control, our findings support the need to develop a comprehensive post-discharge education program or, at least, to ensure that patients have access to a community counselor to compliment the in-hospital educatiop program. brenda stade, tony barozzino, lorna bartholomew, and michael sgro lnttotl#ction: due to the paucity of prospective studies conducted and the inconsistency of results, the effects of prenatal cocaine exposure on functional abilities during childhood remain unclear. unlike the diagnosis of fetal alcohol spectrum disorder, a presentation of prenatal cocaine exposure and developmental and cognitive disabilities does not meet the criteria for specialized services. implications for public policy and services are substantial. objective: to describe the characteristics of children exposed to cocaine during gestation who present to an inner city specialty clinic. mnbods: prospective cohort research design. sample and setting: children ages 5 to 15 years old, referred to an inner city prenatal substance exposure clinic since november, 2003. data collection: data on consecutive children seen in the clinic were collected over an 18 month period. instrument: a thirteen (13) page intake and diagnostic form, and a detailed physical examination were used to collect data on prenatal substance history, school history, behavioral problems, neuro-psychological profile, growth and physical health of each of the participants. data analysis: content analysis of the data obtained was conducted. results: twenty children aged 6 to 14 years (mean= 9.8 years) participated in the study. all participants had a significant history of cocaine exposure and none had maternal history or laboratory (urine, meconium or hair) exposure to alcohol or other substances. none met the criteria of fetal alcohol spectrum disorder. all were greater than the tenth percentile on height, weight, and head circumference, and were physically healthy. twelve of the children had iqs at the 19th percentile or less. for all of the children, keeping up with age appropriate peers was an ongoing challenge because of problems in attention, motivation, motor control, sensory integration and expressive language. seventy-four percent of participants had significant behavioral and/or psychological problems including aggressiveness, hyperactivity, lying, poor peer relationships, extreme anxiety, phobias, and poor self-esteem. conclusion: pilot study results demonstrated that children prenatally exposed to cocaine have significant learning, behavioural, and social problems. further research focusing on the characteristics of children prenatally exposed to cocaine has the potential for changing policy and improving services for this population. methods: trained interviewers conducted anonymous quantitative surveys with a random sample (n= 148) of female detainees upon providing informed consent. the survey focused on: sociodemographic background; health status; housing and neighborhood stability and social resource availability upon release. results: participants were 70% african-american, 16% white, 9% mixed race and 5% native american. participants' median age was 37, the reported median income was <s2,000 year, and 53% reported receiving a high school diploma or equivalent. women reported a number of health conditions rypical of underserved populations, including asthma (42%), sexually transmitted infections (39%), high blood pressure (19%), hcv (14%), diabetes (5%) and hiv (4%). nearly half (46%) did not anticipate having a place to stay for at least 30 days upon release. factors significantly associated housing stability upon release were: high family support score (adjusted odds ratio [aor) 6.15; 95% confidence interval (95% cl) 1.76, 21.61), high neighborhood stability score (aor 4.41; 95% cl 1.25, 15.52), wanting a commercial sex worker (csw) support group (aor 0.25; 95% cl 0.10, 0.62); and identifying as bisexual (aor 0.24; 95% cl 0.07, 0.75). women desired employment (95%), housing (84%), education (77%), drug treattnent (74%), help with custody of children (31 %), childcare (28%), and domestic violence suppon (20%) services. conclusions: female detainees represent one of urban centers' most marginalized pcjpwatioos. short periods of detention represent a unique opportunity for _interven?~ns bri~ co~s and public health institutions. service providers should collaborate ~1th local ~ails to .p~de a con1111uwnof care for female detainees upon release that includes transportation , housing, residential drug treallllcnt, employment, education, family reunification, childcare and domestic viol~nce su~rt. ~pecial attenlion is warranted to lesbian and bisexual women and csws, who may be especially margmalized &om family and service-based support networks. introduction: "health care and ethnic minority immigrants" examines how health care policy dil· ferences between canada and the united states impact the health-related hardships, access and use of preventative care, and health outcomes of urban ethnic minority immigrants in both countries. methods: the findings of this paper build on the results of my qualitative comparative study of hotel workers in vancouver, bc and seattle, wa that revealed greater health related hardships for similarly matched employees in seattle compared to vancouver. in this paper, i examine the generalizability of these findings at the cross-national level for similar ethnic minority immigrant groups. i compare the impact of health care policy differences on specific groups that have emigrated to cities in both canada and the united states. these include immigrants from china, viemam, philippines, west indies, africa, sri lanka, pakistan, and latin america. comparative statistical analysis -utilizing rel· evant data from statistics canada and the u.s. census -reveal the extent to which health policy differ· ences help explain how current health policy in the united states disadvantages urban ethnic minority immigrants. results: many ethnic minority immigrants are a part of the working poor, a group which disproportionately lacks health insurance coverage in the united states. their position in the labour market makes them most vulnerable to exclusion from health care services. the data reveals how current u.s. health policy creates barriers for recently arrived ethnic minority immigrants to access health insurance and care. it remains difficult to ascribe health outcome differences directly to policy differences because of the challenge in disentangling the complex interacting interventing variables, including income inequality, that determine health outcomes. yer suggestive evidence suggests that health policy in the united states is harming the health of urban ethnic minority immigrants. the current health policy regime in the united states harms the health access, care, and outcomes of urban ethnic minority immigrants. comparing the fortunes of similar immigrants in cana· dian and u.s. cities reveals these patterns of disadvantage and some of their consequences. these barriers are an understudied factor in the sociological literature on "segmented assimilation" and social exclu· sion. the paper ends with policy recommendatio ns to improve access to health care among ethnic minor· ity immigrants in both countries, with the goal of reducing health related hardships, and improving health outcomes. mass index deyu pan, richard baker, and keith norris badtgrou~ over the past 3 decades, there has been dramatic increase in prevalence of obesity in the us population. however, the relationship between obesity and the prevalence of cardiovascular dis· ease (cv~) risk factors in different race/ethnic groups over time is not well known. . ik~rgn: _we use 2 cross-sectional , nationally representative surveys: national health and nutri· t10nal examination survey (nhanes iii 1988 -1994 (n= 14 029) and nhanes 1999 nhanes -2002 , including white, black, and hispa~ic races who were no~preg~ant, aged 20 to 74 years. res11lt1: the preval~nce of high cholesterol level (~ 240 mg/dl), untreated high blood pressure (2: l40/90 mm hg) an~ diabetes were calculated according to bmi group (lean, <25; overweight, 25-29; and obese, 2: 30) for different race/ethnicity groups. over the approximately 10 years period (from 1988l ~94 ~o [1999] [2000] [2001] [2002] , reducrion in 3 cvd risk factors in non-hispanic white has been observed. for mmonty race/~hnicity groups, black and hispanic, there had been increases in prevalence in high blood fa pressure and diabetes. the lean group experienced larger increase in prevalence of those cvd risk ctors. . fo~~ the prevalence in cvd risk factors over time had reduced in most of the bmi ca1egoes r t e w ~~e population. however, for black and hispanic, prevalence of 2 of 3 cvd risk factors ave generauy uncreased, especially in overweight and obese groups. methods: strategies identified to achieve these goals include: developing meaningful neighbourhood and district boundaries for comparing health information, providing free access to neighbourhood health profiles (including relevant data at the smallest level for which valid rates could be calculated); mapping relationships of inequality at a variety of nested levels; providing a range of formats (maps, tables) to meet the needs of users; providing technical support; seeking user input to advance and improve the site; and conducting workshops to foster access and use of data for decision-making , advocacy and collaboration. an evaluation strategy is being developed to assess the efforts and impact of these strategies. a preliminary assessment of the results of the first six months of activity will be completed in october 2005. results: significant differences in health are shown at all the geographic levels indicating success in developing the boundaries. results tabulated for the first six months use of the site include: site visits; media use; reference/acknow ledgement of the site in other documents; number of contacts through presentations and workshops; feedback from users identifying strengths and limitations; and, response from health decision makers. members of the partnership are identifying additional tools and services to further support actions that reduce health inequalities. the assessment will be used to develop more specific goals, targets and monitoring mechanisms. conclusions: our experience with paper-based health profiles indicates that they have been used extensively for program planning and advocacy. the greater availability of information in a publiclyavailable web-based format is expected to translate into even greater usefulness and wider application. the web site has had considerable usage to date, extensive media coverage. site users and workshop participants have provided positive feedback and suggestions for next steps. the six month review will be available in october 2005. in india, more than 4 and a half people are hiv-positive and half a million have aids. india currently has the largest number of positive people in the world, oumumbering south africa and accounting for nearly one tenth of the global hiv/aids prevalence. the world bank predicts that by 2015, there will be 35 million hiv/aids cases in india. the central challenge facing hiv prevention efforts in south asia today is learning how to respond to the societal determinants of vulnerability to hiv. hiv/aids is an issue largely engulfed by social stigma. stigma and discrimination are often considered the foremost barriers to effective poster sess10ns v104 prevention and care initiatives. stigma can make a person afraid of disclosing their status~ ~yone el se, and may make them feel depressed or alone. stigma can .also le~d to poor adherence to medicanon, ~ likelihood to access health and social services, and less desire to hve. hiv+ men and women may beafraidtotd! their co-workers that they have hiv for fear of their reactions or for fear of losing their jobs. in a study 1 conducted of people living with hiv/aids in delhi, india ov~r. 2003-~, many respo~ts shared their experiences of discrimination in their families, in their communmes, an~ m health ~e settmgs. these findings will be shared in the workshop, and will be compa~ed to m~ ex~nences workmg as an ~ co~l~ at the center for aids prevention studies in san francisco, cahforma and congreso de lannos unidos m philadelphia, pennsylvania. the workshop will include an overview of hiv/aids in urban contexts in tht united states (los angeles, san francisco, new york, philadelphia) and south asia (delhi, hyderabad, chennai). differences in methods for outreach, prevention and treatment efforts between devdoped world and developing world contexts will be discussed. a large portion of the workshop will be centered on discussion. participants will engage in an exercise to categorize their ideas of stigma. the workshop will also include a powerpoint presentation on the quantitative data gathered from the survey. the number of homeless and runaway youth is increasing in toronto, which is currently home to 3 out of 4 youth in the gt a who live alone, and it is the preferred locale for the street-involved and homeless youth. the city's youth population is expected to grow by nearly 20% by 2011, the school dropout rate is rising, and there are is a paucity of empirical data on what works with these at-risk youth. over a two-year period, (2002) (2003) (2004) , youthlink-inner city, conducted an evaluation of the impact of a harm reduction program aimed at reducing street youth's risk of contracting/infecting others with the hep c virus, which has both short-term and long-term deleterious effects. demographic data from 102 street-youth, along with resources/services used, employment methods, type and frequency of drug use, health status, police contacts, and their views of program impact were analyzed using a standardized sur· vey. additionally, focus groups with youth, agency staff and community key informants were conducted, as well as in-depth interviews with three youth, over a sixth-month period. this paper details study results, which both inform both practice and future study about what works, why it works, and how best to work with these vulnerable youth. sho~ed .that the wasteland in this area was contaminated by as cd zn pb cu simultaneously. the con-ta~matton of as ~d was quit significant. the contamination problems and environmental issues in this region are very. serious. the awareness on environmental and health issues was investigated by spot survey and analysis. overall awareness among the residents in the region is very poor. the measures must be taken to assu~e t~e .sustainable economy development by local and central gorvernments. keywords nandan guangx1; mmmg area; environmental awareness. concern like, epileptic fits, vision problems, earache, cough of more than 3 weeks and urinary problems. ninety-five subjects did not take bath regularly and 42 were exposed to sex. the health problems identified are only of a particular point of time and it may be difficult to interpret the depth of "iceberg" of the street children's world also draw the health-illness continuum. periodic interaction and follow-up is very difficult as they generally disappear from the research setting due to their frequent mobility for survival measures. as per the prediction of the iceberg theory, only some problems may have been identified, larger problems in respect to their health may not have been identified. in spite of various limitations, this attempt had proven that, it is possible to enter the street children world, explore the iceberg of illnesses, and establish data of health-illness continuum through an effective nursing agency. it is recommended to deworm these children, provide nutritional education, establish "condom corners" and "street children help line" in the city and urban slum areas and undertake action research on their health. malnutrition is a serious problem in developing countries like bangladesh. malnutrition causes a great deal of child suffering. malnutrition is one of the major causes of morbidity and mortality among the child. the aim of present study was to investigate the nutritional status and its relation to socioeconomic conditions of urban disadvantaged child of under five years age. nutritional status was determined by anthropoemetric measurement(heig ht, weight, mid-arm circumference etc.). determination of total protein and serum albumin were done for biochemical examination. haematological examination was done by blood haemoglobin profile estimation by cynmethhaemoglob in method and determination of haematocrit value or packed cell volume (pcv). stool examination for ova of hook worm, round worm, trichuris species and other species were also done. relevant information on socioeconomic characteristics was recorded by interviewing the house hold head using pretested questionnaire. our study demonstrated that nutritional status of the children are positively correlated with family income, parents level of formal education and negatively related to the family size. the effect of family income on the nutritional status, haematological and biochemical indices of urban disadvantaged child under five will be discussed in detail which will help us to determine proper way of utilization of health care facilities exists in developing countries. introduction: with the increase in morbidity and reduction in mortality and with the introduction of highly active antiretroviral therapy (haart), there is increasing focus on the determinants of healthrelated quality of life (hrqol) in hiv-infection. the focus on the present study is to examine the relationship between social support, depression, and hiv disease severity, and the extent to which these variables impact on hrqol in adult men with hiv-infection. methods: as part of a larger ongoing natural history study focusing on the neurobehavioural complications of hiv and aids, we administered questionnaires to assess depression (beck depression inventory), social support, and hrqol (mos-hiv) to 366 adult men with hiv-infection. a structured interview was used to collect health information and data on hiv disease severity. physical and mental health summary scores (phs and mhs) were derived through principal components analysis. participants were grouped according to level of social support: "well supported" (n= 180), "moderately supported" (n=90), "little or ineffective support" (n=96). analysis of variance was conducted to assess the effects of three levels of perceived social support, depression status (present vs absent), and hiv disease severity (aids vs non-aids) on mental and physical health dimensions of hrqol. potential interaction effects were also evaluated. results: social support was found to have a significant effect on both mhs and phs. presence of depression was found to have a significant effect on mhs but not phs. hiv disease severity (presence of aids diagnosis) was found to have a significant effect on phs but not mhs. manov a analyses revealed no significant interactions effects. conclusions and implications: level of social support, presence of depression and hiv disease severity were shown to have independent effects on hrqol. feeling "well supported" appears to have significant benefits for mental and physical health. biological indicators of hiv disease appear to have a selective impact on physical health while presence of depression is related to significant reductions in mental health. the development and evaluation of behavioural interventions to improve perceived social support network and depression will likely result in significant improvements in health outcomes of adults with hiv and aids. introduction: ongoing medical advances have greatly enhanced the longevity of penons living with aids (plwa). however, for certain subgroups living with hiv/aids, including, members of minority groups, women and the economically underprivilege d, aids outcomes have not changed so favorably. one obvious factor to consider when explaining disparities in aids outcomes is the environ· ment within which an individual resides. few studies of aids outcomes have focused on how commu· nity setting influences the effectiveness of care delivery. the principle research questions were: 1) what is the relationship between the locations of areas with concentrations of pl wa and the distribution of both primary and ancillary service providers? 2) how has the widespread availability of haart (after 1996) impacted aids outcomes at the community level? 3) how do aids mortality and fatality rates vary when related community characteristics, such as household income, ethnic mix, and geographic access to primary and ancillary hiv/aids services are considered? we examine this issue across residential communities in the los angeles area. methods: los angeles county's comprehensive aids service providers database (compiled and maintained by aids project los angeles) was geo-referenced and distances between weighted mean population centers and the nearest hiv/aids service providers were calculated to provide a measure of access which was then merged with aids diagnosis and mortality data along with relevant socioeconomic and population indicators and for analysis using bivariate and multivariate statistics at the zip code level. results: there is a growing disparity in hiv/aids outcomes between low-income minority areas and affluent non-minority areas in the post-haart era (p = 0.002). ancillary aids services such as case management and counseling and testing are located near the places where low income hiv/aids service consumers are likely to live (p =.000). in spite of having more access to ancillary services low income areas continue to be associated with smaller decreases post-haart aids mortality rates (p=0.301). conclusions: given the increasing disparities in aids outcomes between lower and upper income communities in the post -haart era, more specific research into the capacities of aids services providers and the efficiency of their interventions is required. although it is clear that ancillary services are operating in the areas of greatest need, their effectiveness remains limited. understanding the reasons for t~is, be they lack of adequate resources for inner city service providers, failure to reach target popula· tmns or other causes, requires additional research. in 20?3, y.out~ who were able to speak either french or english and had been absent from their parent's/ c~regivers ~es.1dence for at least three consecutive nights took part in the survey which consisted of inter· viewer-adm1ms tered question~aires. p.arti~i~an~s were recruited from drop in centres in 7 cities across <?-nada.y~uth self-report as either using in1ect1on or non-injection drugs. statistical analyses were car· r1ed out using sas version 8. the 'home' is a contested site for many women living in urban areas. women living in poverty and using illicit drugs are largely excluded from participation in dominant 'home-base' gender roles of wife and mother because of economic disadvantage. they thus 'make home' in ways that are specific to their everyday experiences. while research has established links between housing, health and drug use, this literature does not tend to consider the meanings that home may have within the lives of women who lack access to adequate tenured living spaces. this presentation reports the findings of my master's thesis work. using grounded theory methodology within a poststructuralist feminist conceptual framework, i conducted in-depth, open-ended interviews with 11 women living in the toronto area. the women were recruited from within the community through posters at different social service agencies (e.g., drop-in centres, community health centres). they were asked to describe their housing experiences and what home meant to them over the course of their lives. through the data analysis process, a substantive theory of 'making home' for women living in poverty and using illicit drugs emerged. the central concept of making home is a continual process of learning about and interacting with the environment. the process of making home entails different subprocesses: finding home (knowing what is available and accessible, and accessing home), adaptation, and leaving home. the different meanings of home that women developed from their experiences and knowledge emerged as critical components for the process of making home. the women i interviewed were very mobile and experienced constant change with regards to home. home was not considered only in relation to physical living space. home could be made within a relationship or with regards to a possession. while dominant meanings of home relation to tenured living spaces are generally positive, my research indicated that home could also be a negative context. the presentation will describe my research process and findings as well as the theoretical and policy implications of my results. in the western democracies, social citizenship bundles the right to social provision (defined as a share of the social good, not necessarily proportionate to the market value of a citizen's contribution) with participation in the paid labour force. for this reason, social citizenship rights, which usually involve some kind of redistributive measures, are a key mechanism by which states ensure economic equality, or at least, economic equality of opportunity, but are also a mechanism of social exclusion. social rights are inscribed around a single kind of relationship, that which exists between a male family breadwinner and the paid labor market; those who make economic contributions that fall outside this relationship -such as unpaid care-work, or, work that occurs in shadow or underground economiesare to a greater or lesser degree barred from accessing citizen-based social provisions. furthermore, social provision that occurs outside of the breadwinner/market-eco nomy dyad is very often meanstested and is accompanied by regulatory state apparatuses (this includes a range of social services, from welfare payments, to child-care subsidies, to disability pensions). social citizenship is thus stratified; the legal relationship that is at the heart of social citizenship acts as a form of social closure against claims for a share of the social good made by those who are 'lesser' citizens than others. of particular interest in this paper is how citizenship inequalities translate into inequalities in the social provisions that emerge from economic participation: the right to safety on the job, protection from employer harassment, protection from the vagaries of the market as well the right to adequate, comprehensive, and appropriate health services. drawing on mixed methods, longitudinal data from adult sex workers (n= 170) located in two research sites with different social welfare regimes -one in canada and one in the u.s. -we examine the consequences of working in a "shadow" or "underground" economy on various facets of health and access to health services, taking into consideration the mediating role that citizenship constructs and social welfare regimes play in accessing other key social and economic determinants of health. methods: the study population included methadone patients (re)admitted at the mhs in the period from 1/1/1996 to 31/1/2002, born in the netherlands, morocco, surinam, dutch antilles or turkye, and officially registered in the population register of amsterdam. the population register was used to ascer· rain the vital status. causes of death were provided by the central bureau of statistics. mortality was categorised as hiv related, directly drug related (overdose) and other.mortality. results: the methadone patients had the following characteristics: 38 years of age at entry; 81% male; 37% ethnic minority; 37% ever injected. in total, 9558 personyear (py) of observation time and 173 deaths (18% hiv related, 14% overdose; 57% other) were observed. hence, the crude mortality rate was 18/1000 py (95% ci 16-21/1000 py). the percentage of (ever) injectors was higher among the native dutch than among the ethnic minorities, 51 % and 14 % respectively. higher rates were observed among native dutch drug users compared to those belonging to an ethnic minority (age adjusted hazard ratio (hr) 1.9 (95% ci 1.4-2.7). the age adjusted hr of (ever) injecting drug users versus non injecting users was 3.0 (95% cl 2.2-4.1 ). after additional adjustment for route of administration a non significant difference between the dutch and ethnic minorities remained (hr 1.3, 95% cl 0.9-1.9, p-value 0.151. conclusion: the mortality rate among the heroin users in amsterdam is strongly affected by the high prevalence of non-injecting drug use. moreover, this study confirms that differences in mortality between the native dutch and the ethnic minorities is related to differences in route of administration. the ongoing reduction of injecting drug use (due tot selctieve mortality, and switching route ofadministration and popularity of crack cocaine) may lead to a further reduction of mortality rates among heroin users in amsterdam. interventions preventing the initiation of injecting should be encouraged. . introduction: food insecurity is an inequality that is central in the lives of many low-income cana· d1ans. people lack food security when regular access to nutritious food is limited or variable due to high prices'. low income, lack of transportation or inadequate food distribution, or they become disadvan· taged m other w~ys through the acquisition of food. a group comprising academics, health profession· als, and commumty workers who have experience in food insecurity, developed a pilot study in ottawa that sought to und~rstand the lived experience of food insecurity. the study also used the united states department of agriculture (usda) community food security module. methods: a series of group meetings determined the best research approaches; questionnaires and consent forms were developed by a working group. twenty-three self-identified food insecure respon· dents were interviewed. the data were analysed using frequency distributions· the food security module was coded according to the usda coding guide, and open-ended responses w~re coded using a grounded approach. renlts: preliminary results from our pilot study have given the research team cause for considerable concern. out of 14 households without children, 11 experienced food insecurity with hunger; 5 ~ere at the severe l~vel. out of 9 households with children, 7 experienced food insecurity with hunger. ~•rst person reflecnons commonly featured feelings of depression low self-esteem and despair. participants' account tha d . an 1 cu ty gettmg to the store, severely limited putting knowledge and skills mto practice. l'oster sessions v109 conclusion: based on these early findings, our research team is looking to challenge what appear to be assumptions about poverty and food insecurity and for best ways to use this information. some policy approaches and interventions that encourage people to eat better and exercise more, may be missing the mark for low-income individuals, and may serve to maintain food insecurity. future research will build on this pilot. with methods augmentation, and a comprehensive knowledge dissemination plan, we hope co contribute to research and policy frameworks at all levels. ps-25 (a) mental health and the corrections system: population-based analyses in urban, semi-urban, and rural settings julian somers, robert watts, and michelle patterson introduction: according to recent epidemiological research, rates of mental disorders vary considerably across countries and across regions within countries. nevertheless, rates of mental disorders (including substance use disorders) are consistently higher in populations involved in the corrections sys-1em. courts have long recognized the heavy burden of mental illness within their purview, and have developed innovative programs to better manage the needs of such individuals. the majority of these innovations (e.g., specialized courts) exist in urban settings. however, few studies have examined the degree of variability in rates of different mental disorders between courts in urban and other settings (e.g., semi-urban, rural). variability between courts in different settings, if present, holds implications for needs-based resource planning. the present study was conducted as part of a long-term inter-ministerial collaboration in british columbia (bc). analyses were conducted on linked administrative data regarding population health and correctional services. a database was constructed including all individuals sentenced in bc in a single year (n=49,142). corrections records were matched to records of health services utilization (hospital and outpatient services) for mental disorders and substance use disorders in the years preceding sentencing. services for mental health and substance-related problems were aggregated into three groups: severe mental illness (smi); less-severe mental illness (lsmi); alcohol/other drug (ad). courts were grouped, based on their annual volumes, inro three categories: "urban"; "semi-urban" and "rural." rates of service use for mental disorders were compared between groups for 1-year and 5-years preceding sentencing. results: there were significant differences in the rates of mental disorders in courts of different size (urban, semi-urban, rural) . however, differences between the rates of disorders within each of these groups exceeded the discrepancies between groups. comparatively high and low rates of disorders were observed in courts of each size. moreover, the courts with the highest rates of certain disorders (e.g., ad) did not have the highest rates of other types of mental disorders (e.g., smi). conclusions: rates of mental disorders differed significantly among the annual populations sentenced across courts in bc. urban courts (which process comparatively large numbers of people) have implemented services to address the needs of the mentally ill. the present analyses strongly suggest that program development should be closely linked to the demonstration of need. the results caution that a uniform approach to court programs for the mentally ill is likely to be inefficient, over-supplying services in some settings and underestimating need in others. results: public settings used for injection are characterized by highly unhygienic conditions, the presence of unsafely disposed syringes, limited availability of sterile syringes and a lack of sterile water for injecting. a number of unsafe injection practices observed were common among public injectors. the presence of police officers nearby and the potential of assault by street predators fostered rushed injecting among those consuming drugs in public spaces. the ecological features of these environments encourage unhygienic and unsafe injecting practices, heighten risk for overdose and the transmission of blood borne viruses. introduction: approximately 13% of women experience depression in the first weeks or months after giving birth. although it has been argued that postpartum depression (ppd) is a culture-bound p~ nomenon, experienced only in western, industrialized countries, recent international research studies have confirmed that the prevalence of ppd is similar around the world. however, little is known about variables that may influence the experience of ppd in women from diverse cultures and immigrant women. research is needed to identify the role culture may play in the presentation of ppd (i.e., types of symptoms most commonly reported), how women from various racial, ethnic and cultural backgrounds perceive and attribute their symptoms of ppd, and finally, how culture can be appropriately addressed in ppd treatment programs. method: to examine the role of culture in ppd, semi-structured interviews and self-report question· naires were administered to clients of the women's health centre of st. joseph's health centre, tor· onto. participants were identified as either first generation canadians (relative newcomen) (n=8) or second generation canadian (parents were immigrants to canada) (n=6). data were collected qd these two groups of women based on: severity of depression, symptom presentation, perceived role of social supports and culturally-specific traditions, and barriers and responses to treatment. the interview data were analyzed using qualitative methods (thematic content analysis), and the following themes were identified: 1) stress about passing on their culture to their children, 2) lack of social support and feelings of isolation, 3) perceived importance or lack of importance of cultural based tra· ditions, 4) conflicts with family members. about cultural traditions and beliefs, 5) mental health stigma within ethnic communities and beyond, 6) race-and sex-based discrimination, and 7) language barriers. conclrllion: identifying the role culture plays in the presentation of ppd, and how women from diverse backgrounds perceive and attribute their symptoms of ppd, is critical in order to establishcultur· ally appropriate guidelines for treatment options. furthermore, information gathered from this study can be used to develop policies and resources for delivering culturally competent care for newcomer wo~ who are dealing with ppd as well as the issues around acculturation (i.e., language barriers, racism). llus is of particular importance for urban health centers which provide postpartum care to diverse groups of women, and particularly recent immigrants or newcomers. ps-~8 (al. contaminated 'therapeutic landscape': perceptions of the aamjiwnaang fint nation keyln smith and isaac luginaah . in~: this. paper pres;ents the findings of an ongoing study among the aamjiwnaang f!rst nanon. aam11wnaang is located m the heart of samia's 'chemical valley', surrounded by cherrucal ~(ants such as esso, imperial oil, shell, suncor energy, and canada's largest hazardous waste disposal sate. safety kleen. this fint nation community is located within the st. clair river •area of concem'. as destgna~ by health canada for the population of samia and the surrounding region. although this comm_umty, by way of. its proximity to the numerous chemical plants is already exposed to high levels pollu~on, recent che?ucal dumping in ~mjiwnaang, as well as a failed proposal for another ethanol plant m the community, only helped to mtensify community concerns about potential health impacts of exposure. research on the cultural beliefs and traditions of first nation communities has established that th~ ~isting rel~tionship between first nations people and 'mother earth' is not only physical, but also_ spmtual. in this study we explore how the complex relationship between the aamjiwnaang first naaon and 'mother earth' be ha · · · i .. may c ngmg 111 a contammated 'therapeutic' landscape. the study a so ~lores h?w aam11wnaang residents are coping with these changes and with the probable conramina· boa of their community. ra!jts: aamjiwnaang residents acknowledge that they are living in a contaminated environment and are being impacted by emissions from the surrounding 'chemical valley' especially for future generations, and have expressed concerns that members of the community and mother earth are 'sick' as a result of this exposure. while moving from that 'place' has been discussed, residents have strong personal and generational connections to the land and insist however, that aamjiwnaang is their 'home' and will remain that way despite growing community concerns about the impact from industry. the contribution of this study lies in the direct involvement of community leadership in designing and conducting this research and distributing the results to further local policy development regarding community concerns on the reserve. background: truck driver are at very high risk for drug abuse because the factor contributing to drug abuse among driver are multiple. it is important to gain an understanding of the key factors that contributing to drug abuse among truck drivers. methods: seventy-truck driver aged 25-35 years were conveniently selected from the population. all the participants were male. an interview schedule was developed in the light of literature data and data were collected by personal interview with informed consent in selected urban area of eastern part of nepal. results: a considerable percentage of truck driver have less knowledge about drug abuse, its effect on body and their complication. majority of the participants (90%) explained that lack of education, financial crisis were leading factors of drug abuse. the average numbers of respondents were believed that lack of meaning in life, marital disharmony. friendship with drug abuser, stress, tiredness, modernization of life pattern and freedom from the home pressure were the influencing risk factors to drug abuse. conchuion: this study reveals those truck drivers are at risk in urban area for developing drugs abuse, mostly influenced by social and environmental factors. hence, these groups should undergo certain educational programme to prevent not only drug abuse, but also prevent transmission of infectious disease among these groups. introduction: food insecurity is an inequality that is central in the lives of many low-income canadians. our group of university researchers, health professionals, and community developers conducted a study in ottawa with community workers who work with people identified as food insecure. the purpose of the study was to understand the nature of their work, and their perspectives, perceptions and experiences of the causes and consequences of food insecurity. (a parallel study was conducted with food insecure participants). methods: sampling was through local knowledge of organizations involved in the provision of food to community members. written permission for the researchers to contact workers in confidence was obtained from each organization. thirteen in-depth interviews were conducted. the interviews consisted of a number of open-ended questions. the data were collated, and analysed using a grounded approach. results: workers interviewed represented organizations that offered diverse programming and methods of food distribution intended to address the needs of the community. the provision of food was seen as a necessary response to address hunger that arose for the majority from poverty caused by low income, or levels of government income support and safety nets that were insufficient to support food requirements. workers reported that food requirements varied according to different. ethnic backgrounds, ages of recipients and family configurations, and with food preferences, and d'.etary (health) requirements. workers' observations of the effects of insufficient food on adults and children such as depression, low energy and non-participation or social disengagement matched those of food insecure respondents. food insecurity was cited as "another srressor among the mountain of problems." overall, workers presented a picture of a silent, stigmatized, poor population including children, and a lack of advocacy to address the issues. be tha th · ·ty the results suggest that workers and organizations, like the commuruty mem rs t ey msecun • · · · · f ilab'l' f food · t d ·n thei·r ab1'l1'ty to address food insecurity. l1m1tanons m terms o ava 11ty o , serve, are restnc e 1 . . funding, and donations appeared to set the para?1eters of pr~g:am r.espon~ to commuruty food msecurity. workers were concerned with program des1g": and a~m1mstranon that m general addr~d hunger on an emergency short-term basis, although food msecunty was long-ter_m for ~any. sustainable solutions that include knowledge translation strategies, and health and social pohcy responses were suggested and will be explored in future research that hopes to build on this pilot. background: socioeconomic deprivation as well as low levels of soc!al s.uppoi:r have .been associated with poor outcomes following cardiac surgery. pre-operative depression m ~anents with coron~ry artery disease awaiting cabg ranges from 27-47% and is an independent predictor of post-operanve mortality. since st. michael's hospital has a large inner city population, this study was designed to determine the both the prevalence of depressive symptomatology (ds) in patients awaiting cabg as well as its relationship with socioeconomic status (ses) and social support. methods: consecutive patients referred for isolated cabg were invited to complete the centre for epidemiological studies depression scale (ces-d) as well as a social support scale and a life stressors inventory. a ces-d score of 2: 16 represents mild ds and a score of 2:27 represents moderate to severe ds. participants also recorded information on functional status, perceived progression of heart failure, demographic and ses variables. all participants with ces-d scores 2: 16 were considered to have ds. results: of the 75 patients (75%) who returned the survey, 22 (29.3%) of participants had a ces-d score 2: 16 with 8 (10.7%) of those having scores suggestive of severe depression. females and those with ongoing medical concerns tended to have more ds (p= 0.06 and p= 0.07 respectively). age was not related to ds. perceived worsening of symptoms and increased ccs angina class were significantly related to the presence of ds (p= 0.03 and p= 0.03 respectively) but not the number of diseased heart vessels. satisfaction with personal relationships including having someone to confide in (p=0.01), feeling lonely (p= 0.04) and not having a partner (p= 0.007) were significantly related to ds. being very upset by a recent breakup in the immediate family was also significantly related to ds (p= 0.02). having greater than a grade 9 education was the only ses variable related to ds (p=0.06). multivariate logistic regression suggested that not being partnered and having low education were the most significant predictors of ds. conclnsion: pre-operative depression is present in at least one quarter of patients referred for cabg. since ds is related to poor outcomes following cabg, single patients with few social supports and low education should be considered at high risk for ds. these findings support the need for the development of supportive interventions in patients at risk in order to decrease post-operative morbidity. this study examines the relationship between childhood sexual abuse, sexual assault during adolescence, and hiv-risk-related behaviours in a sample of 919 homeless youths. over the past decade, there has been increasing research devoted to the impact of childhood sexual abuse. some studies have suggested that the experience of childhood sexual abuse is associated with substance use and abuse, at· risk sexual behaviour and subsequent higher rates of hiv infection (ompad et al., 2005; cinq-mars et al., 2003; brown et al., 1997) . other studies have found that childhood abuse, especially sexual abuse, is c_o~n among stree~ youth (noell et al. 1999 ). this study compares sexually abused males and females livtng on the street ~th non-sexually abused street youth, with regards to unsafe sexual behaviours and e~ures to potmnal t:dv sources (e.g., tattooing, body piercing and injection drug use). the hypothe-sis oft~ ~nt study is that the prevalence of hn-risk-related behaviours will be higher among street youth vtctuns of sexual abuse than those who have not been sexually abused. the sample includes 919 youths aged 13 to 25 who met specific criteria's for itinerancy (649 male and 270 female, with a mean ~of 19.4 y· and a standard deviation of 2.9). they were recruited through five organisations working ~th~ you~ and were~ of an ongoing cohort study. all youth completed a 45 to 60 minute ques· ~onnaue on their sexual behaviours, use of drugs and alcohol and other hiv risk behaviours. oral spec· unens for hiv testing were. also collected. a total of 357 (38.9%) youth reported at least one incident of ~i •~use/assault (1~1 girls (67.0% of all the girls) and 176 boys (27.2% of all the boys]). preliminary descnpnve analyses pomt to sexually abused/assaulted youth showing the highest prevalence of sexual poster sessions v113 at-risk behaviours. for example, 43.3% of sexual abuse/assault victims have engaged in prostitution in their lives compared with 13.4% in the non-sexually abused/assaulted group. in addition, 42.6% of sexual abuse/assault victims reported having injected drugs, compared with 32.0% in the non-sexually abused/assaulted group. more statistical analyses will bring other significant factors to light, especially when we analyze separately those victim of childhood sexual abuse as compare to those victim of sexual assault after childhood. elucidating the risk factors for getting involved in hiv-risk-related behaviours is important for the development of comprehensive and appropriate prevention and treatment intervention strategies. introduction: new immigrants and refugees to canada frequently emigrate from regions of the world where intestinal parasitic infections with worms are endemic. of note, some of these parasites area capable of surviving for years to decades within a given host and can have life threatening consequences many years after initial infection. thus, early diagnosis and treatment of intestinal parasitic worms is considered important in high risk immigrant populations, however there remains a lack of consensus regarding the best method of accomplishing this. diagnosing worm infections through stool examinations is costly and has limited sensitivity, while presumptive treatment of all immigrants, although advocated by some, is expensive and results in healthy individuals being unnecessarily treated. herein, we examine the utility of a hematologic marker (i.e. peripheral blood eosinophilia) as a screening instrument to identify parasitic worm infections in new immigrants to toronto. we identified 192 adults, 15 years of age or older, who were screened for intestinal parasitic infections by stool examination as part of a recently developed screening protocol at a downtown toronto community health centre. we examined the prevalence of infections with worms and subsequently evaluated the impact of several demographic factors on the presence of worm infections. we also determined the sensitivity and specificity of peripheral blood eosinophilia (defined as greater than 500 eosinophils per ml) as a marker for intestinal parasitic worm infections. results: overall, 21 % of the 192 immigrants tested had evidence of at least one worm infection on a single stool examination, while 4% of such individuals bad infections with multiple worms concurrently. age did not appear to be associated with the presence of worms, however 29% of males had evidence of worm infections compared with 16% of females (p= 0.03). immigrants from asia, sub-saharan africa, and central america had the highest burden of overall infection. the sensitivity and specificity of peripheral blood eosinophilia for worm infections was 24% and 92% respectively. conclusions: one in five recent immigrants presenting to a community health centre in downtown toronto had evidence of at least one intestinal parasitic worm infection. the highest burden of illness was in men and in those emigrating from less developed regions of the world. peripheral blood eosinophilia is a poor screening test for worm infections however its presence is highly suggestive of the existence of worms in new immigrants. more than a decade ago, the journal of american college health recommended that a national study be conducted to measure the health status of african american college students, 'both health disparities and [their] positive healthful behaviors' (fennell, 1994) . it was later decided that when exploring the level of health risk behaviors for african american students, gender is an important variable and should be included in the research (fennell, 1997) . at historically black college and universities (hbcus) college health researchers must tackle gender disparities through highly-effective health promotion and disease prevention programs. the purpose of this review is to examine the literature that addresses the overarching health behaviors (i.e. risky sexual behavior, poor diet, smoking, physical inactivity, etc.) of african american men who attend hbcus. despite the various social, cultural, and academic benefits of african american students who attend hbcus, the number of research studies that adequately address their health and health behaviors is limited. studies indicate that african american men who attend hbcus are actively engaged in poor health behaviors. compared to females at hbcus, african american men are more likely to behave in ways that could result in injuries and the use tobacco, alcohol, and ~ther dru~. the city of toronto has recently proposed to conduct a street count of the homeless. like proposals that have come before, this most recent proposal is controversial among many homeless advocates and service providers because it is perceived as intrusive, likely to undercount the target population, and unnecessary for addressing the problem. advocates of the count view it as necessary to gauge the scope of the problem and advise city leaders about how to most effectively direct resources ro.the various homeless services. this paper first reviews the history of efforts to count homeless populat10ns m toronto, describing the motivations and arguments of people on both sides of the issue. second, the paper reviews the methodological complexities of counting homeless populations, describing approaches that use shelter-counts, administrative data and street observations. those interested in counts for toronto and elsewhere can benefit from this review of approaches that have been proposed and carried out in other municipalities. third, the paper proposes a new community-base d strategy that joins the skills of methodologists, local experts, and service providers to ensure a fair and accurate count. the method of systematic social observation avoids some of the problems of early counts by utilizing a repeated identification approach to minimize undercount bias. the method also has the advantage of involving and compensating homeless individuals for assisting with the street count estimates. the estimation approach can be implemented on a rolling basis throughout the year. drug transitions) is a multi-level study aimed at examining the associations between features of the urban environment and mental health, drug use, and risky sexual behaviors. research participants are being recruited in 36 new york city (nyc) neighborhoods. an essential first step in the implementation of this study was to delineate boundaries for each target neighborhood that could then be used to establish sampling frames and as key units of analytic interest. although many neighborhood studies rely on pre-established definitions (e.g. those used for the census or administrative purposes), such definitions do not always reflect contemporary settlement patterns. we felt that street level observations were a neces· sary component of the definition process. methods: the procedures used to delineate neighborhoods were: (1) development of census block maps of targeted areas; (2) review of land use maps and census tract data to ensure, prior to going into the field, tha.t particular blocks are residential and likely to have sufficient population for recruitment purposes; and (3) field vislts and observation in each of the targeted areas. field observations focused on: housing characteristics, including housing type and condition; characteristics of commercial areas, such as likely customer base (e.g. local or no~, socio-economic status and ethnicity of customers); pedestrian volume (including con· gregauons of people m parks and outside stores or residences); obstructions to pedestrian traffic (e.g. ma1or thoroughfares, multi-block industry or institutions); and maintenance and use of open spaces. results: in making the final decisions regarding neighborhood boundaries and the inclusion or exclusion of particular. blocks, we considered a broad range of factors including evidence of homogeneity an~ heterogeneity (socmeconomic, ethnic, housing type, environmental) across blocks within and blocks ad1acent to a nei.ghborhood, and across the 36 sample neighborhoods; the potential for efficient recruit· ment of appropriate particip.ants (i.e. sufficient local pedestrian traffic); and boundaries used in reporting census data (s? that population data can be used in our analysis). . altho~gh utilization of field observations for neighborhood definitions is relatively time consuming (ap~~ox1mately 2 hours for a 12 block area, with more diverse neighborhoods taking even longer), we annc1p~t~ that it will substantially improve the quality and consistency of our data gath· ~rmg ~nd analyse~. spec1f1c e?'amples from neighborhoods defined through this process will be given dur· m~ this presentatmn. we will also discuss the merits and limitations of characterizing neighborhoods usmg street level observations. has been no consideration for how social networks are associated with sse. the objective of this study was to identify personal and social network characteristics associated with being a recipient of sse. in this cross-sectional study, idus who injected in the past 6 months were recruited from syringe exchange programs in montreal, canada, between april 2004 and january 2005. information on each participant and on the persons with whom contact had occurred in the past month were elicited using a structured, interviewer-administe red questionnaire. participants provided detailed demographic and drug use information on up to 5 idu members with whom drugs or injecting materials were shared. using logistic regression, personal and network characteristics were examined in relation to receipt of sterile syringes. res.its: of 277 idus, 39% reported receiving sterile syringes in the past month from another idu. the sample mean age was 33 years (range 18-55), 73% male, 91 % caucasian, and 85% cocaine injectors. in multivariate analyses adjusted for age and gender, recipients of sterile syringes were more likely than non-recipients to share drugs after preparation (0r=2.39(1.06-5.42 )), to require help or to have helped inject another idu (or= 3.48(1.60-7.60)), to have asked someone to get sterile syringes from a syringe exchange program (or=2.54[1.20-5.40 )), to lend syringes (or=2.44[1.16-5.16) ) and to use drug preparation water that was previously used by another iou (0r=2.46(1.42-4.28) ) during the past 6 months. recipients also had a higher rate of change (p=0.01) of idus in their drug injecting network during the past month. with respect to social networks, 45% ( 171/348) of idu network members were providers of sterile syringes and were more likely than non-providers to inject everyday (or= 2.50( 1.51-4.15)). when stratified by their role as a sexual partner or as someone who provides support (e.g. friend, family member), further risk behaviours were observed in relation to sharing injecting materials with the participant. conclusion: recipients of sterile syringes and their idu network members had several high-risk behaviours for infection with bloodborne diseases. sse may afford an opportunity for the dissemination of other salutary behaviours such as information sharing on safe injecting practices between recipients and distributors. furthermore, drug injecting networks may be an avenue to reach idus who may not otherwise be exposed to preventive measures. there are numerous sources of stigma and labelling of mental and physical illness. first, the sociocultural dimension to stigma and labelling clearly influences patients, families, health care professionals and society's perception and treatment of illness. this creates multiple challenges related to illness identification and recovery, particularly in culturally diverse societies. second, the media is a major source of stigma and stereotyping with regard to a variety of mental and physical illnesses. despite increased public knowledge of many illnesses, studies have shown that stigma has intensified over the years in certain cases. a third element of stigma and labels appears with the use of diagnosis as a solution to human problems with the result that difficult to treat patients are repudiated and social issues are unaddressed. this presentation will serve to outline the development of stigma, various expressions of stigma, and consequences of stigma. it will provide some practical recommendations for the reduction of stigma related to mental and physical illness. purpose: to assess the knowledge, attitude, and practice about immunization for parent of 2-3 years old hispanic and african american children in los angeles county (lac). methods: we conducted two cluster surveys in lac. the sample was selected with probability proportionate to estimated size at the first stage and simple random sample of children at the second stage. data were collected through interview. we absuacted vaccine coverage data from immunization record card (irc) at home or from clinic records. the participation was 81 % in hispanics and 83% in african americans populations. irc was not available at home for 26% of african american and 16% of hispanic children. results: all parents perceived their children got all necessary vaccine~. fa~orable attitudes to.w~rd immunization were reported by 82 % of african american and 90% of h1s?amc parents. '.he m~1ority of the parents (90% african american and 95% hispanic) agreed that vaccines prevent senous d1se~ses among children. regarding vaccine safety, significantly more hispanic parents (91 %) than african american parents (75%) mentioned that vaccines are safe. introduction: cervical cancer has been shown to be preventable by papanicolau tests in heterosexual women; however, the utility of papanicolau test in lesbians is controversial. cervical cancer is caused by the human papillomavirus (hpv) which is transmitted by sexual _intercourse; howev_er, its' transmission by homosexual intercourse is also controversial. the goal of this study was to review the evidence for papanicolau tests in lesbians. methods: a pub med, ovid ( 1996 ovid ( to 2005 , and cochrane library search was performed using the mesh headings "homosexuality , female," "vaginal smears," and "papillomavirus, human." in pub med, the clinical queries feature was used with "diagnosis" and "broad, sensitive" filters. a google advanced search of the internet was conducted with the terms "lesbian," "cervical cancer," and "pap rest." the url was limited to ".ca," ".edu," or ".gov." results: the search yielded 8 original articles and 4 reviews, but no cochrane reviews. none of the publications were canadian. 111 website hits were found and selected websites were reviewed. studies showed that lesbians have fewer papanicolau tests than heterosexual women; however, many reported risk factors for cervical cancer, including multiple past or current sexual partners (male and female), early age of first coitus, history of sexually transmitted diseases, and cigarette smoking. hpv has been detected in 13-30% of lesbians and 6-19% of lesbians who have never had sex with men. case studies of abnormal papanicolau tests in lesbians who have never had sex with men have also been reponed. sexual transmission of hpv among lesbians can be explained by several factors: 1) 53-99% of lesbians have had sex with men and 21-30% of lesbians continue to have sex with men. 2) hpv may be transmitted by sexual behaviours among women, like digital-vaginal sex, digital-anal sex, oral sex, and the use of insertive sex toys. 3) hpv transmission requires only skin-to-skin contact. genital hpv has been identified on human fingers. some professional organizations, like the society of obstetricians and gynecologists of canada and the american cancer society, recognize the need for papanicolau tests in lesbians. other organizations, like the canadian cancer society, do not have official policy statements. the current ontario cervical screening program does not specifically address lesbians. conclusion: although the data was limited, most studies recommended that lesbians should receive papanicolau tests. the frequency of these tests was controversial. policy makers and professional organizations should address the needs of this special population and make specific recommendations . monique chaaya, ahia sibai, hiam chemaitelly, and zana el roueiheb . literature concerning the mental and physical effect of work at an old age is contradictory. in addinon, urban environments are physically and socially harsh with reduced potential for income generation and employment and increased potential for depression. the present paper is an attempt to study how do work, or lack of work, link to the experience of depression among older adults in underprivileged lebanese urban communities. the data comes from a cross-sectional survey, where 740 elderly residing in 3 underprivileged communities in beirut, including a palestinian refugee camp, were successfully inter-v1ewed through face-to-face interviews. logistic regression was performed to assess the effect of work on depression ad_justing for many other covariates. data showed that 17.5% of people aged 60 years and more were still workmg. there was a highly protective effect of work on depression in elderly males (or= 0.342, 95% cl= 0.128-0.909). the current study is the first of its kind in the arab region and more work shou_ld be _don_e in this area. it is important for the lebanese government to consider elderly rights for social mclus10n m terms of employment opportunities. amam nuru-jeter, nancy adler, and burton singer . l~u~on:_ the socioeconomic gradient is perhaps the most persistent and significant finding in social epidem1ological research. the insistent nature of the ses effect is evidenced by its significance after acc?untmg for ~umerous confounds. the significance and magnitude of the effect, however, varies by ::•al group. evidence_ o_f the relative effect of race and ses is inconclusive. further, less attention has f ~ ptid to the specific interactions of race and ses than to examinations of which is a better predictor 0 d ~ th. ~sues are further complicated by the explanatory complexity of the various measures of ses anl . owht ey relate to the health of various social groups. understanding the specific nature of these re a11ons ips 1s necessary for guiding he ith d · i 1· · h a an soc1a po mes and programs aimed at improving t e poster sessions v117 health of our most disadvantaged groups, and therefore population health, overall. this study examines the synergistic effects of ses with both race and gender in predicting group differences in mortality. methods: analyses use data from the national longitudinal mortality survey (n= 559, 715) for the years 1979, 1980, and 1981-85; and were linked to the national death index for deaths occurring through 1985. results were confirmed using data from the national mortality followback survey for people who died in 1986 (n= 13,491) and the 1986 national health interview survey (denominator). we used correlation analysis and the standardized mortality ratio to examine ses (education and income), race, and gender as predictors of group differences in changes in mortality. results: for the total population, analyses support the income gradient showing significant declines in mortality ratios from low to high income along the income strata. education shows a significant drop in mortality with completion of high school and completion of college, exhibiting a threshold rather than a gradient effect. compared to whites, blacks receive diminishing health returns for each subsequent level of income and education; with whites closely mirroring the total population in ses thresholds. similarly, compared to men, women do not experience the same health gains at comparable ses levels. for education, black men and women only show significant mortality declines upon completion of high school. the ses gradient operates differently among race and gender subgroups. threshold effects suggest resource gains in life opportunities at particular milestones along the ses gradient. further, ses matters less for blacks and women compared to whites and men suggesting differing implications for health and social policy aimed at reducing disparities. objective: we assessed the impact of diabetes in a large puerto rican community of chicago by measuring the prevalence of diagnosed diabetes and calculating the diabetes mortality rate. methods: we analyzed data from a comprehensive health survey conducted in randomly selected households in community areas. questions on diagnosed diabetes and selected risk factors were asked. in addition, mortality data were analyzed in order to calculate the age-adjusted diabetes mortality rate. when possible, rates were compared to those found in other studies. results: the diabetes prevalence located in this community (20.8%: 95% cl= 10.1 %-38.0%) is one of the highest ever reported for puerto ricans. for instance, it is more than three times higher than the prevalence for the us (6.1 %) and twice the prevalence for puerto ricans in new york ( 11.3%) and puerto rico (9.3%-9.6%). diagnosed diabetes was found to be significantly associated with obesity (p=0.023). the prevalence was particularly high among older people, females, those horn in the us, and those with a family history. the diabetes mortality rate (67.6 per 100,000 population) was more than twice the rate for all of chicago (31.2) and the us (25.4). conclusions: understanding why the diabetes and mortality rates for puerto ricans in this commu· nity are so much higher than those of other communities is imperative. collaboration between researchers, service providers and community members can help address the issues of diabetes education, early screening and diagnosis and effective treatment needed in this community. introduction: sars is a respiratory illness that is spread from person to person through dose contact. this infectious disease outbreak was unusual due to the high rate of infection among health care workers. the aim of the study is to explore the demographic and attitudinal determinants of psychological distress due to sars among health care workers of a toronto hospital. methods: a total of 997 adult participants completed questionnaires co assess psychological distress (impact of event scale -jes) and attitudes to sars. of these, 845 participants completed the questionnaire during the sars i outbreak, and 152 participants completed the questionnaire during the sars ii outbreak. participants also provided information on demographic variables, including occupation and exposure to sars. principal components analysis was used to derive eight attitudinal scales: fear: system, protection, prevention, job stress, stigma, instrumental coping, and psychological copm~. l111ear regression analyses were applied to evaluate the associations of the demographic and amtudmal variables, as well as time, with psychological distress. . . regression analyses showed that time and higher scores on fear, 1ob stress, stigma'. and instrumental coping were associated with a higher total ies score: (r2 =.30). contrary to expectations, none of the demographic variables was associated with total ies score. conclusion: the presence of psychological distress in health care workers is indicative of intrusive or avoidant responses to thoughts, feelings, and memories associated with the sars outbreak. this study shows that ( 1) fear for one's health and the he~lth of.others, (2) ex~erien~in~ job stress, (3)_tbe per· ception of stigma, (4) usage of instrumental copmg skills, ~n~ (5) t1m_e s1grufi~an~ly c~nmb~te to increased psychological distress in health care workers. potential mterventmns during mfecttous diseaie outbreaks in health care settings should be targeted to minimize the impact of these factors. purpose: the purpose of this study was to expand knowledge regarding feeding practices, know!· edge and nutritional beliefs of mothers currently residing in the dominican republic (dr). the rising incidence of obesity in children is a major national health concern and obesity in first and second-generation immigrant children also continues to rise. we know that parents (particularly mothers) shape children's early diet patterns and that immigrant mothers experience additional challenges related to acculturation and assimilation into a new culture, however there is a paucity of literature concerning the effect of immigrant adaptation to american culture on the nutrition of children. in addition, new immigrant knowledge about the causes of obesity and the resulting health implications for childhood obesity has not been assessed and reported. this qualitative study used focus group methodology to discuss views and practices related to the introduction of food for infants and feeding practices for young children, along with a discussion on knowledge and beliefs related to the causes and health implications of child· hood obesity. ten dominican mothers' of young children (birth to 6 years old) who reside in a small town in the western frontier area of the dr were participants in the focus group. results from this srudy will be compared to results from an identical study that will be conducted in fall 2005 with new immi· grant mothers from the dr to the boston area. we will compare feeding practices, beliefs and knowledge about nutrition for young children between these two groups. methods: using participatory principles, a focus group design was used to interview a group of mothers in the dr. the investigator along with a bilingual translator conducted the focus group. the session was tape recorded and is currently in the process of being transcribed and translated. transcribed data will be systematically analyzed themes will be identified. a qualitative data analysis software will be used to organize and code the data according to the specific aims of the study. supporting quotations will be selected to substrate each theme. lmpli~tions for urban health practice: an ultimate goal of this study is to lay a foundation for understanding the process of acculturation on feeding practices of mothers when they immigrate to the us. understanding beliefs, knowledge and feeding practices that mothers use with young children will help m ~he ~evelopment of culturally and linguistically appropriate educational strategies and materials for use m primary prevention of pediatric obesity. in canada more than seventy-five percent of immigrants choose to stay in three major urban centers of toronto, montreal and vancouver. approximately fifty percent of the immigrants eventually set· tie m ~~e greater tor<_>nto area. there is mounting evidence that the increasing immigrant population has a_ sigmfic~nt health disadvantage over canadian-born residents. this health disadvantage manifests particularly m the ma1"ority of 1"mm1"gr t h h d be · · h . . . . an s w o a en m canada for longer than ten years. this group as ~n associ~te~ with higher risk of chronic disease such as cardiovascular diseases. this disparity twccb n ma1onty of the immigrant population and the canadian-born population is of great importance to ur an health providers d" · i i · b as isproporttonate y arge immigrant population has settled in the ma1or ur an centers. generally the health stat f · · · · · · h h been . us 0 most 1mm1grants 1s dynamic. recent 1mm1grants w o av_e ant •;ffca~ada _for less ~han ~en years are known to have a health advantage known as 'healthy imm1• ~ants r::r · ~:s eff~ 1~ defined by the observed superior health of both male and female recent immiimmigrant participation in canadian society particularly the labour market. a new explanation of the loss of 'healthy immigrant effect' is given with the help of additional factors. lt appears that the effects of social exclusion from the labour market leading to social inequalities first experienced by recent immigrant has been responsible for the loss of healthy immigrant effect. this loss results in the subsequent health disadvantage observed in the older immigrant population. a study on patients perspectives regarding tuberculosis treatment by s.j.chander, community health cell, bangalore, india. introduction: the national tuberculosis control programme was in place over three decades; still tuberculosis control remains a challenge unmet. every day about 1440 people die of tuberculosis in india. tuberculosis affects the poor more and the poor seek help from more than one place due to various reasons. this adversely affects the treatment outcome and the patient's pocket. many tuberculosis patients become non-adherence to treatment due to many reasons. the goal of the study was to understand the patient's perspective regarding tuberculois treatment provided by the bangalore city corporation. (bmc) under the rntcp (revised national tuberculosis control programme) using dots (directly observed treatment, short course) approach. bmc were identified. the information was collected using an in-depth interview technique. they were both male and female aged between 4-70 years suffering from pulmonary and extra pulmonary tuberculosis. all patients were from the poor socio economic background. results: most patients who first sought help from private practitioners were not diagnosed and treated correctly. they sought help form them as they were easily accessible and available but they. most patients sought help later than four weeks as they lacked awareness. a few of patients sought help from traditional healers and magicians, as it did not help they turned to allopathic practitioners. the patients interviewed were inadequately informed about various aspect of the disease due to fear of stigma. the patient's family members were generally supportive during the treatment period there was no report of negative attitude of neighbours who were aware of tuberculosis patients instead sympathetic attitude was reported. there exists many myth and misconception associated with marriage and sexual relationship while one suffers from tuberculosis. patients who visited referral hospitals reported that money was demanded for providing services. most patients had to borrow money for treatment. patients want health centres to be clean and be opened on time. they don't like the staff shouting at them to cover their mouth while coughing. conclusion: community education would lead to seek help early and to take preventive measures. adequate patient education would remove all myth and conception and help the patients adhere to treatment. since tb thrives among the poor, poverty eradiation measures need to be given more emphasis. mere treatment approach would not help control tuberculosis. lntrod#ction: the main causative factor in cervical cancer is the presence of oncogenic human papillomavitus (hpv). several factors have been identified in the acquisition of hpv infection and cervical cancer and include early coitarche, large number of lifetime sexual partners, tobacco smoking, poor diet, and concomitant sexually transmitted diseases. it is known that street youth are at much higher risk for these factors and are therefore at higher risk of acquiring hpv infection and cervical cancer. thus, we endeavoured to determine the prevalence of oncogenic hpv infection, and pap test abnormalities, in street youth. ~tbods: this quantitative study uses data collected from a non governmental, not for profit dropin centre for street youth in canada. over one hundred females between the ages of sixteen and twentyfour were enrolled in the study. of these females, all underwent pap testing about those with a previous history of an abnormal pap test, or an abnormal-appearing cervix on clinical examination, underwent hpv-deoxyribonucleic (dna) testing with the digene hybrid capture ii. results: data analysis is underway. the following results will be presented: 1) number of positive hpv-dna results, 2) pap test results in this group, 3) recommended follow-up. . the results of this study will provide information about the prevalence of oncogemc hpv-dna infection and pap test abnormalities in a population of street youth. the practice implic~ tions related to our research include the potential for improved gynecologic care of street youth. in addition, our recommendations on the usefulness of hpv testing in this population will be addressed. methods: a health promotion and disease prevention tool was developed over a period of several years to meet the health needs of recent immigrants and refugees seen at access alliance multicultural community health centre (aamchc), an inner city community health centre in downtown toronto. this instrument was derived from the anecdotal experience of health care providers, a review of medical literature, and con· sultations with experts in migration health. herein we present the individual components of this instrument, aimed at promoting health and preventing disease in new immigrants and refugees to toronto. results: the health promotion and disease prevention tool for immigrants focuses on three primary health related areas: 1) globally important infectious diseases including tuberculosis (tb), hiv/aids, syphilis, viral hepatitis, intestinal parasites, and vaccine preventable diseases (vpd), 2) cancers caused by infectious diseases or those endemic to developing regions of the world, and 3) mental illnesses includiog those developing among survivors of torture. the health needs of new immigrants and refugees are complex, heterogeneous, and ohen reflect conditions found in the immigrant's country of origin. ideally, the management of all new immigrants should be adapted to their experiences prior to migration, however the scale and complexity of this strategy prohibits its general use by healthcare providers in industrialized countries. an immigrant specific disease prevention instrument could help quickly identify and potentially prevent the spread of dangerous infectious diseases, detect cancers at earlier stages of development, and inform health care providers and decision makers about the most effective and efficient strategies to prevent serious illness in new immigrants and refugees. lntrodmction: as poverty continues to grip pakistan, the number of urban street children grows and has now reached alarming proportions, demanding far greater action than presently offered. urbanization, natural catastrophe, drought, disease, war and internal conflict, economic breakdown causing unemployment, and homelessness have forced families and children in search of a "better life," often putting children at risk of abuse and exploitation. objectives: to reduce drug use on the streets in particular injectable drug use and to prevent the transmission of stds/hiv/aids among vulnerable youth. methodology: baseline study and situation assessment of health problems particularly hiv and stds among street children of quetta, pakistan. the program launched a peer education program, including: awareness o_f self and body protection focusing on child sexual abuse, stds/hiv/aids , life skills, gender and sexual rights awareness, preventive health measures, and care at work. it also opened care and counseling center for these working and street children ar.d handed these centers over to local communities. relationships among aids-related knowledge and bt:liefs and sexual behavior of young adults were determined. rea.sons for unsafe sex included: misconception about disease etiology, conflicting cultural values, risk demal, partner pressur~, trust and partner significance, accusation of promiscuity, lack of community endorsement of protecnve measures, and barriers to condom access. in addition socio-economic pressure, physiological issues, poor community participation and anitudes and low ~ducation level limited the effectiveness of existing aids prevention education. according to 'the baseline study the male children are ex~ to ~owledge of safe sex through peers, hakims, and blue films. working children found sexual mfor~anon through older children and their teachers (ustad). recommendation s: it was found that working children are highly vulnerable to stds/hiv/aids, as they lack protective meas":res in sexual abuse and are unaware of safe sexual practices. conclusion: non-fatal overdose was a common occurrence for idu in vancouver, and was associated with several factors considered including crystal methamphetamine use. these findings indicate a need for structural interventions that seek to modify the social and contextual risks for overdose, increased access to treatment programs, and trials of novel interventions such as take-home naloxone programs. background: injection drug users (idus) are at elevated risk for involvement in the criminal justice system due to possession of illicit drugs and participation in drug sales or markets. the criminalization of drug use may produce significant social, economic and health consequences for urban poor drug users. injection-related risks have also been associated with criminal justice involvement or risk of such involvement. previous research has identified racial differences in drug-related arrests and incarceration in the general population. we assess whether criminal justice system involvement differs by race/ethnicity among a community sample of idus. we analyzed data collected from idus (n = 1,084) who were recruited in san francisco, and interviewed and tested for hiv. criminal justice system involvement was measured by arrest, incarceration, drug felony, and loss/denial of social services associated with the possession of a drug felony. multivariate analyses compared measures of criminal justice involvement and race/ethnicity after adjusting for socio-demographic and drug-use behaviors including drug preference, years of injection drug use, injection frequency, age, housing status, and gender. the six-month prevalence of arrest was highest for whites (32%), compared to african americans (25%) and latinos (27% ), in addition to the mean number of weeks spent in jail in the past 6 months (7.0 vs. 5.8 and 4.2 weeks). these differences did not remain statistically significant in multivariate analyses. latinos reported the highest prevalence of a lifetime drug felony conviction (48%) and mean years of lifetime incarceration in prison (13.3 years), compared to african americans (48%, 10.7 years) and whites (34%, 6.9 years). being african american was independently associated with having a felony conviction and years of incarceration in prison as compared to whites. the history of involvement in the criminal justice system is widespread in this sample. when looking at racial/ethnic differences over a lifetime including total years of incarceration and drug felony conviction, the involvement of african americans in the criminal justice system is higher as compared to whites. more rigorous examination of these data and others on how criminal justice involvement varies by race, as well as the implications for the health and well-being of idus, is warranted. homelessness is a major social concern that has great im~act on th~se living.in urban commu?ities. metro manila, the capital of the philippines is a highly urbanized ar~ w.1t~ the h1gh~st concentration of urban poor population-an estimated 752,229 families or 3,005,857 md1v1duals. this exploratory study v122 is the first definitive study done in manila that explores the needs and concerns of street dwdlent\omc. less. it aims to establish the demographic profile, lifestyle patterns and needs of the streetdwdlersindit six districts city of manila to establish a database for planning health and other related interventions. based on protocol-guid ed field interviews of 462 street dwellers, the data is useful as a template for ref!!. ence in analyzing urban homelessness in asian developing country contexts. results of the study show that generally, the state of homelessness reflects a feeling of discontent, disenfranchisem ent and pow!!· lessness that contribute to their difficulty in getting out of the streets. the perceived problems andlar dangers in living on the streets are generally associated with their exposure to extreme weather condirioll! and their status of being vagrants making them prone to harassment by the police. the health needs of the street dweller respondents established in this study indicate that the existing health related servias for the homeless poor is ineffective. the street dweller respondents have little or no access to social and health services, if any. some respondents claimed that although they were able to get service from heallh centers or government hospitals, the medicines required for treatment are not usually free and are beyond their means. this group of homeless people needs well-planned interventions to hdp them improve their current situations and support their daily living. the expressed social needs of the sucet dweller respondents were significantly concentrated on the economic aspect, which is, having a perma· nent source of income to afford food, shelter, clothing and education. these reflect the street dweller' s need for personal upliftment and safety. in short, most of their expressed need is a combination of socioeconomic resources that would provide long-term options that are better than the choice of living on the streets. the suggested interventions based on the findings will be discussed. . methods: idu~ aged i 8 and older who injected drugs within the prior month were recruited in 2005 usmg rds which relies on referral networks to generate unbiased prevalence estimates. a diverse and mon· vated g~o~p of idu "seeds." were given three uniquely coded coupons and encouraged to refer up to three other ehgibl~ idu~, for which they received $5 usd per recruit. all subjects provided informed consent, an anonymous 1~t erv1ew and a venous blood sample for serologic testing of hiv, hcv and syphilis anti~!· results. a total of 213 idus were recruited in tijuana and 206 in juarez, of whom the maion!)' were .male < 9 .l.4% and 92.2%) and median age was 34. melhotls: using the data from a multi-site survey on health and well being of a random sample of older chinese in seven canadian cities, this paper examined the effects of size of the chinese community and the health status of the aging chinese. the sample (n=2,272) consisted of aging chinese aged 55 years and older. physical and mental status of the participants was measured by a chinese version medical outcome study short form sf-36. one-way analysis of variance and post-hoc scheffe test were used to test the differences in health status between the participants residing in cities representing three different sizes of the chinese community. regression analysis was also used to examine the contribution of size of the chinese community to physical and mental health status. rmdts: in general, aging chinese who resided in cities with a smaller chinese population were healthier than those who resided in cities with a larger chinese population. the size of the chinese community was significant in predicting both physical and mental health status of the participants. the findings also indicated the potential underlying effects of the variations in country of origin, access barriers, and socio-economic status of the aging chinese in communities with different chinese population size. the study concluded that size of an ethnic community affected the health status of the aging population from the same ethnic community. the intra-group diversity within the aging chinese identified in this study helped to demonstrate the different socio-cultural and structural challenges facing the aging population in different urban settings. urban health and demographic surveillance system, which is implemented by the african population & health research center (aphrc) in two slum settlements of nairobi city. this study focuses on common child illnesses including diarrhea, fever, cough, common cold and malaria, as well as on curative health care service utilization. measures of ses were created using information collected at the household level. other variables of interest included are maternal demographic and cultural factors, and child characteristics. statistical methods appropriate for clustered data were used to identify correlates of child morbidity. preliminary ratdts: morbidity was reported for 1,087 (16.1 %) out of 6,756 children accounting for a total of 2,691 illness episodes. cough, diarrhoea, runny nose/common cold, abdominal pains, malaria and fever made up the top six forms of morbidity. the only factors that had a significant associ· ation with morbidity were the child's age, ethnicity and type of toilet facility. however, all measures of socioeconomic status (mother's education, socioeconomic status, and mother's work status) had a significant effect on seeking outside care. age of child, severity of illness, type of illness and survival of father and mother were also significantly associated with seeking health care outside home. the results of this study have highlighted the need to address environmental conditions, basic amenities, and livelihood circumstances to improve child health in poor communities. the fact that socioeconomic indicators did not have a significant effect on prevalence of morbidity but were significant for health seeking behavior, indicate that while economic resources may have limited effect in preventing child illnesses when children are living in poor environmental conditions, being enlightened and having greater economic resources would mitigate the impact of the poor environmental conditions and reduce child mortality through better treatment of sick children. inequality in human life chances is about the most visible character of the third world urban space. f.conomic variability and social efficiency have often been fingered to justify such inequalities. within this separation households exist that share similar characteristics and are found to inhabit a given spatial unit of the 'city. the residential geography of cities in the third world is thus characterized by native areas whose core is made up of deteriorated slum property, poor living conditions and a decayed environment; features which personify deprivation in its unimaginable ma~t~de. there are .eviden~es that these conditions are manifested through disturbingly high levels of morbidity and mortality. ban · h h d-and a host of other factors (corrupt10n, msens1t1ve leaders 1p, poor ur 1ty on t e one an , . · 1 f · 1 · · th t ) that suggest cracks in the levels and adherence to the prmc1p es o socta 1usnce. ese governance, e c . . . . . ps £factors combine to reinforce the impacts of depnvat10n and perpetuate these unpacts. by 1den· grou o . ·1 "id . . bothh tifying health problems that are caused or driven by either matena _or soc1a e~nvanon or , t e paper concludes that deprivation need not be accepted as a way. of hfe a~d a deliberate effon must be made to stem the tide of the on going levels of abject poverty m the third world. to the extent that income related poverty is about the most important of all ramifications of po~erty, efforts n_iu_st include fiscal empowerment of the poor in deprived areas like the inner c~ty. this will ~p~ove ~he willingness of such people to use facilities of care because they are able to effectively demand 1t, smce m real sense there is no such thing as free medical services. ). there were 322 men with hiv-infection included in the present study (mean age and education of 41.8 (sd=8.4) and 13.9 (sd=2.7), respectively). a series of multiple regressions were used to examine the unique contributions of symptom burden (depression, cognitive, pain, fatigue), neuropsychologic al impairment (psychomotor efficiency), demographics (age and education) and hiv disease (cdc-93 staging) on iirs total score and jirs subscores: ( 1) activities of daily living (work, recreation, diet, health, finances); (2) psychosocial functioning (e.g., self-expression, community involvement); and (3) intimacy (sex life and relationship with partner). resnlts: total iirs score (r 2 "0.43) was associated with aids diagnosis (ii= 0.11, p <0.01) and symptoms of pain (ii= -0.14, p < 0.01 ), fatigue (ji = -0.34, p < 0.001) and cognitive difficulties (p =0.30, p < 0.001 ). for the three dimensions of the iirs, multiple regression results revealed: ( 1) activities of daily living (r2=0.42) were associated with aids diagnosis (ii =0.17, p < 0.01) and symptoms of pain <p =-0j6, p < 0.01 ), fatigue (ji = -0.31, p < 0.001) and cognitive difficulties (ji =0.32, p < 0.001 ); (2) psychosocial functioning (r2=0.31) was associated with was associated with symptoms of fatigue (ii= -0.25, p <0.001) and cognitive difficulties <ii =0.19, p <0.001); and (3) intimacy (r2=0.17) was related to was associated with symptoms of fatigue (ij = -0.17, p < 0.01) and cognitive difficulties (ii= 0.19, p < 0.001 ). methods: the sif evaluation methodology involves a comprehensive database located at the sif, a randomly selected p~o.spective coh~rt of sif users, and two pre-existing external control cohorts. . . ~ts: in addmon to reporting process data and descriptions of the sif users, we report on data indicating that the establishment of the sif has been independently associated with reductions in public ~':°g ~ (p <?.001), and syringe sharing (aor =0.3[95%ci: 0.1 _ 0.7); p =0.013) and other unsafe m1ecnon pract1_ces_ (p ~ 0.010), and increased uptake of detox services (log-rank p =0.017). as well, we report on da~ md1cat1ng that the sif has not prompted adverse changes in community drug use patterns. the vancouver sif has been well accepted by the target population, and while adve~ events s~c~ as overdoses have occurred, these events have been successfully managed. externally compiled data indicate that the sif has been associated with substantial declines in public disorder !'oster sessions v125 associated with injection drug use, syringe sharing, and increased uptake of detox services. as well, the establishment of the sif has not exacerbated community drug use patterns. ongoing evaluation activities wiu involve assessing the impact of the sif on a variety of outcomes, including infectious disease transmission, fatal overdose, and utilization of health and social services. city, brazil, 1996 -2002 maria cristina almeida, waleska caiaffa, renato assum;iio, and fernando proietti dengue cases were described according to time, space, intensity, age, gender, onset of symptoms, residence address and census tract. spatial distribution of two groups (children and women over 64 years old and men aged 20-59) were compared, under assumption that they have distinct behaviors regarding their displacement around the city. analysis included local moran index, ripley\\'s k function and recurrence of census areas over time. about 99,559 cases were identified in seven epidemic waves. concentration of cases in small areas, followed by a spread either in space or time suggested endemic patterns. regarding age-gender groups, distinct patterns suggested that residence might not be a good proxy in determining the local of infection for men aged 20-59. dengue is shifting to endemic pattern in this city and transmission may not be sole related to home environment, suggesting that additional spatial information must be couected aiming efficient control measures. murukan kandamuthan and subodh kandamuthan lnl7uduction: illness or disablement of a child may affect the economic functioning of a family as it alters the employment pattern and earnings of parents this paper tries to assess the health status and the quality of life of disabled children, and how generally, severe disablement in a child affected their fami-lies\' finances, and to quantify any such effects the problems faced by children in their home and to provide information relevant to the formation of criteria for new or increased cash support. methods: a case-control study was done in the thiruvananthapuram district, capital city of kerala by selecting a random sample of 300 families with severely disabled children below 15 years and a random sample of 300 normal children matched for age and occupation of the parents. comparative and subjective data were collected. money spent on children\'s medical care, loss of earnings of the parents, and other economic burden to the family due to the disability of the child in the family. a discriminant analysis along with univariate analysis was done to assess the factors that mostly differentiate the disabled and normal children. the mean expenditure of the families with a disabled child was rs. 852/-per month, which is significantly higher than the corresponding expenditure of rs. 389/-per month of families with normal child, (t= 16.86, p <.00001). of the disabled children, 81 % were not getting any social security payments and 90% had no special concessions for medical and other educational purposes. the analysis of income and expenditure pattern indicated that financial impact of disablement in a child on the family is significant. the discriminant model results revealed that medical expenditure was a significant variable that differentiated the disabled and normal child. the study found that the health status and quality of life of the disabled children were far from satisfactory. this in fact affected the economic status of the disabled children. in addition to reduced earnings, there are extra costs for disabled children for travel, domestic help, medical care, and health care expenditures (hospital care, physician services, dentistry, drugs and others) for disabled individuals. a strong case can be made for their long-term care by improving the financial support to such families possibly through the introduction of an allowance specially to compensate for the earnings lost by parents due to the disability of their children. widows in india are considered disadvantage group of population. because they are characterized by pangs of separation from spouse, and consequently they go through mental agony, social ~s?lation, and economic dislocation. in addition to these, poverty, landlessness, homelessness, malnutr1non etc. endure serious deterioration of their health. according to census 2001, there are 44 million women are widowed and one fourth live in urban areas. there is a noticeable increase of urban widows from the previous census (almost half). the paper examines the type of disability and chronic ailment borne among elderly widows (60 years and above). fifty second round of national sample survey aske~ the individuals three sets of questions regarding their health: their status of health, whether they are physically poster sessions v126 immobile, and whether or not they have had any specific chronic illnesses. although health infrastruc-1 1 ·1 ble 1 ·n urban setting in india as compared to rural counterpart, prevalence of tures are arge y ava1 a . . . . . h · ·11 · h h"gher 1 "n urban areas analysis shows 1omt problems m old age qmte common c romc 1 ness is muc 1 • . . and nearly 44 percent elderly widows are suffering from this ail'.11ent in urban areas. one-fifth of widows are suffering from high/low bp. heart disease, diabetes and urinary problems are much ~ore pre~alent in urban areas though disabilities is comparatively lower in urban areas. however, the d~fference is not statistically significant. disability with respect to vision is more pronounced and one third_ of the total respondents have problems regarding eyesight. one fifths ofdderly widows are _ha.rd of hearing. though disability increases with age, similar trend is not observed with respect to chr~mc illness. the percepnon of self-health among elderly becomes poorer as their age increases. the perceived health status need not be always corrected to objective indicators of health. it is noted that around 27 per~en~ of those perceived their health as "excellenr" or "very good" are found to be suffering from chrome disease of1omts and 17 percent have visual disability. to conclude an elderly widow living in urban areas have similar health problems as she jives in rural areas. this can be easily explained, as they were not made aware to seek treatment from health facility. in addition, the study shows that the economic conditions are deterrent factors for their illness. it is essential that intervention should be taken up improving their economic conditions so that wellbeing of this most vulnerable group of the society can be taken care of. heart failure is a disease that affects nearly 15 million people world wide. the united states alone accounts for one third of this population. blacks are stricken with heart failure twice as often as whites. men are more likely to develop chf than women, however since the majority of the chf population are seniors, there are actually more women than men. congestive heart failure (chf) has become a pandemic. as the baby boomer generation ages, the number of chf cases will rise dramatically. (young, j. & mills, r.,2004). after the age of 45, each proceeding decade doubles the incidence level of chf. the average person has a 1 in 5 chance of developing heart failure within their lifespan according to the framingham study (nih.gov). individuals aging 65 or older compose over half of the entire documented heart failure population. in this age group, chf is the leading cause of hospitalization. many patients are continuously readmitted. it is estimated that the chf population will increase by one million within the next 25 years. mortality was at 50% for a two year period and 70% for five years (young, j. & mills, r.,2004 ). data from: aha as technology evolves, the understanding of the nature of heart failure has become clearer. in the beginning of the 20th century heart failure was diagnosed as a condition that presented with edema (swelling) in the extremities caused by water retention. treatment in the beginning of the past cenrury was limited to abdominal drainage and diuretics. the discovery of the heart's insufficient pumping ability in heart failure patients lead to new surgeries and devices such as heart transplants and ventricular assist devices (bridge until transplant is available). ventricular hypertrophy often occurs before the development of heart failure. hypertrophy is the term given for cardiac remodeling. cardiac remodeling also includes chamber dilation (young, j. & mills, r.,2004) . chf financial burden the us healthcare financing administration has ranked chf as the highest cost illness in the diagnose-related area. direct costs related to chf in the us for 2004 were nearly $26 billion. these costs included hospital admissions, physician fees, home health aids and medications. indirect costs were over $2 billion in 2004. loss of jobs or death due to chf was the criteria for this category (young, j. & mills, r., 2004). . introduction: the injection drug user quality of life scale (iduqol) is a relatively new scale ~es1gned to capture the unique and individual circumstances that determine quality of life among injection drug users (idus). the 20 life areas comprising the instrument were based on the research literature an~ ~ocus group discussions with idus. the purpose of the present study was to evaluate the content validity of t.h~ iduqol using judgmental methods based on subject matter experts' (smes) ratings. content vah~1ty refers to the de~ee to which elements of an assessment tool are representative of the construct of interest and appropnate for a given population. methods: data were obtained from six smes, from the field of idu research and practice, who ~ere. asked t.o evaluate various aspects of the iduqol, including the title of the instrument, administraon instruchons, clarity of the names and descriptions of each life area, response format, scoring instruc-no~s and examples, record form and whether each life area should be included in the instrument. sme ratings were made using either 3 or 4 point scales. sm es were also given the opportunity to comment on poster sessions v127 each section and to suggest whether important life areas had been overlooked, were redundant, not relevant, or in need of revision. (cvi) and the ~v.erage ~eviation index (ad) were used to evaluate smes' agreement on ratings of the content vahd1ty vanables. both measures provided support for the content validity of various aspects of the iduqol, although results from the stricter ad index noted some areas of disagreement, including the description of particular life areas (e.g., being useful, drugs, sex), the inclusion of some life areas (e.g., drug treatment, education, independence and free choice), and the ease of the scoring instructions. the findings from this study provide (a) content validity evidence to support the use of the iduqol as well as (b) recommendations to suengthen both the instrument (e.g., improved descriptions for some items) and the accompanying administration and scoring manual (e.g., an easier scoring template). changes made to the instrument and its manual make the iduqol even easier for researchers, practitioners, and program evaluators to use as a way of assessing, and tracking changes over time or as a result of interventions in, quality of life in injection drug users. introduction: strict adherence to prescribed regimens is required to derive maximal benefit from highly active antireuoviral therapy (haart) in persons living with hiv/aids (phas). adherence is a key determinant of the degree and durability of viral suppression. adherence is also essential in reducing the spread of hiv and ensuring that today's treatments remain effective for as long as possible. the objective of this study is to conduct a systematic review of the research literature on the effectiveness of education and patient support strategies for improving adherence to haart. methods: a systematic search of the core databases was performed from january 1996 until may 2005. randomized controlled trials examining the effectiveness of education and patient support interventions to improve the adherence to haart were considered for inclusion. only those studies that measured adherence at a minimum of six weeks were included. study selection, quality assessments, and data abstraction were performed independently by two reviewers. results: study heterogeneity with respect to differing populations, interventions, outcomes, and length of follow-up did not allow for meta-analysis. we included 19 studies involving 2, 159 ph as. sample sizes ranged from 22 to 367. study duration ranged from a single session to a variable number of sessions delivered over one year. many of the interventions involved the provision of an educational component to improve adherence and often addressed strategies to overcome barriers to adherence and the development of problem-solving skills. they ranged from simple interventions (e.g., the provision of reminder devices) to complex interventions (e.g., cognitive-behavioural therapy delivered by licensed psychologists). eleven of the 19 studies demonstrated a statistically significant advantage associated with the described adherence intervention. the advantage associated with adherence outcomes does not seem to translate into the more clinically relevant outcome of viral suppression. only 4 out of 12 studies that reported virological or immunological results found a significant effect associated with the intervention. the studies had several methodological shortcomings. conclusions: there is a need for standardization and methodological rigour in the conduct of adherence trials. some interventions may have a significant impact on improving adherence. further research is required before any specific adherence improving strategy can confidently be incorporated into standard clinical practice. focus groups were used to collect data from a purposive sample of treatmentexperienced participants. focus group data were analyzed using a grou~ded t~eory appr~ach. i:ne themes identified from the interviews were used to identify the effects of ant1rerrov1rals on quality of hfe. the content of the mos-hiv was appraised against the themes identified from our analysis. participants also completed the mos-hiv survey and were asked whether the survey covered all important aspects of quality of life on antiretroviral medications. results: five key informant interviews and five focus groups with 38 participants were used to identify effects on quality of life that are not directly ~aptu~ed by_ the mos-hiv health survey. our~~ showed that our participants described quality of hfe as mvol~mg_ a set of ~rsonal trad~ffs ~stay alive. in most cases, worsened quality of life was traded-off for gams 1~ longevlty from ~~canon use. these eff~'ts or tradeoffs included: ( 1) downstream consequences of side effects and toxlanes; (2) loss of lrufe. pende~t decision-making privileges, (3) having to choose drugs over ~areer; (~)burden of medication-taking responsibilities; and (5) living life under a pretense and havmg to hide-the net effect of the tradeoffs, or "prices" to pay led to what was described as "longevity with hn without hope and future~. conclusion: our study highlights five major themes summarizing the impact of haart on quality on life, and suggests that currently used scales for measuring quality of life do not a~atd~ cap~e these findings and the associated consequences. the conceptual framework for measuring quality of bfe in hiv should be reconsidered in order to better capture the important effects of the medications on quality of life. this may involve widening the boundaries of the definition of health-related quality oflife to include aspects such as finances, employment, and housing. we should further consider the development of a haart adverse effect specific instrument, using a broad definition of adverse effect in order to capture all types of adverse impacts of hiv treatments on quality of life. introduction: measles (rubeola) is the most contagious vaccine preventable disease of humans. while cases of measles are uncommon in canada today, the disease continues to be a leading cause of morbidity and death in the developing world. as a result of human migration, measles cases still occur in canada, primari~ among immigrants, returning travelers, and other susceptible groups. canada's national advisory council on immunizations (naci) recommends that immigrants without records of measles immunization be considered for vac:cination since these individuals may not have been appropriately vaccinated in their native country. on rhe other hand, natural immunity to measles in immigrants is likely to be high given the high incidence of disease in developing parts of rhe world. thus it remains unclear if the most efficient strategy to achieve high levels of measles immunity in immigrants should entail initial serologic screening followed by vaccination of susceptible individuals or preemptive vaccination of all persons lacking immunization records. understanding the epidemiology of measles immunity in immigrant populations could help guide such decisions. . methods: we identified 527 adults, 15 years of age or older, who were screened for serologtc immunity to measles as part of a recently developed screening protocol at a downtown toronto community health centre. we subsequently determined if these individuals had any immunization records from their native country or from within canada. we then examined the relationship between several demographic factors and immunity to measles. results: 93% of immigrants had no prior immunization records. overall, 93% of the 527 immigrants rested for immunity to measles were found to be immune; 88% of those under the age of 20, 93% of those between 20 and 39 years of age, 99% of those between 40 and 59 years of age, and 100% of those 60 years of age or older. gender, education status, household income, and immigration status were nor ~ssoc1ated wirh immunity to measles. immunity to measles was lowest among immigrants from eastern europe (8~%), whil~ immigrants from other regions of the globe had greater than 90% immunity. c~lusrons: immigrants and refugees appear to have reasonably high levels of immunity to mea· sics, possibly related to natural infection wirh the measles virus. immigrants from eastern europe appear to have slightly. lower l~vel~ of immunity to the measles virus. universal screening for immunity to meales or preemptive vac:cmauon may both be inefficient public health strategies, however further research is needed to corroborate these findings. nancy r~ss, stephane tremblay, saeeda khan, daniel crouse, mark tremblay, and jean-marie berrhelor o~ve: the speed of the rise in obesity in places like canada suggests that rather than a shift in the gcncnc_ com~sirion of the population, the root of the obesity pandemic is an environment that suprrs ~besity. this paper examines the influence of neighbourhood and metropolitan characteristics. bour~lts:. while accounting. for individual socio-demographics and behaviours, residents of neighs with a large proportmn of poorly educated individuals had higher bmis than those living in poster sessions v129 neighbourhoods with more highly educated individuals (p <.01 ). residing in a neighbourhood with a high proportion of recent immigrants was associated with lower bmi for men (p<.01), but not women. neighbourhood dwelling density, a proxy for walkability, was not associated with bm! for either sex. metropolitan sprawl was associated with higher male bmi (p=.02) but the effect was negligible for women (p=.09). bmi was significantly lower for women (p<.01) living in a city in the province of quebec, even after accounting for the influence of individual and neighbourhood covariates. conclusions: bm! was strongly patterned by individual-level social position in urban canada. the incremental influence on bmi of neighbourhood related to the neighbourhood's social conditions and not to their physical form. metropolitan sprawl was associated with higher bm! for men, a group with longer car-dependent commutes than women. the findings suggest that both individuals and their environments (both social and physical) influence the distribution of bmi in urban populations. introduction: urban environments have been linked to a range of human health issues. in singapore, prevalence of end stage renal disease (esrd) is predicted to rise (2633 in 1999 to 6000 in 2010 , kidney international, vol.67, 2005 . the clinical and economic burden of esrd has promoted development of strategies aimed at preventing the development and progression of chronic kidney disease. these include population based screening programs such as the national kidney foundation, sin-gapore\'s (nkfs) "partnership for prevention."the program, aims to reduce incidence of esrd through comprehensive intervention and screening for early detection of urinary abnormalities, blood pressure (bp), and random blood glucose (rbg). objective of this study is to examine gender, race and age wise prevalence of elevated bp, rbg and proteinuria. methodology: this current analysis includes 575,438 subjects, age 18 to 86 years, who underwent screening during september 1999 and december 2004. participants were asked to give demographic information and the history of diseases. tests were given to get clinical information such as proteinuria, blood glucose, sbp, and dbp. blood pressure abnormalities were defined according to ]nc vi criteria. proteinuria was defined as the presence of 1 plus or greater protein (equivalent to> 30 mg/di) on dipstick analysis. results: there were 296, 116 (51.5%) males. racial distribution was chinese (78.8% ), malay (8.8% ), indians (8. 7%) and others (3. 7% ).among participants, who were apparently "healthy" (asymptomatic and without history of dm, ht, or kd), gender and race wise % prevalence of elevated (bp> 140/90), rbg (> 140 mg/di) and positive urine dipstick for protein was as follows male: (20.5;6.9; 3.5) female:(13.6;5.0;3. 2) chinese:( 17.1;6.0;3) malay: (19.4;7.3;5.6) indian:( 15.9;7.5;3.0) others: (15.4;4.5;2.9) total:(l 7.1, 6.1,3.2). percentage of participants with more than one abnormality were as follows. those with bp> 140/90mmhg, 14% also had rbg> 140mg/dl and 6.4% had proteinuria> i. those with rbg> 140mgldl, 11 % also had proteinuria> 1 and 35% had bp> 140/90mmhg. those with proteinuria> 1, 18% also had rbg> 140mg/dl, and 38% had bp> 140/90mmhg. conclusion: we conclude that sub clinical abnormalities in urinalysis, bp and rbg readings are prevalent across all genders and racial groups in the adult population. the overlap of abnormalities, point towards the high risk for esrd as well as cardiovascular disease. this indicates the urgent need for population based programs aimed at creating awareness, and initiatives to control and retard progression of disease. introduction: various theories have been proposed that link differential psychological vulnerability to health outcomes, including developmental theories about attachment, separation, and the formation of psychopathology. research in the area of psychosomatic medicine suggests an association between attachment style and physical illness, with stress as a mediator. there are two main hypotheses explored in the present study: ( t) that individuals living with hiv who were upsychologically vulne~able" at study entry would be more likely to experience symptoms of depression, anxiety and phys1ca! illness over. the course of the 9-month study period; and (2) life stressors and social support would mediate the relat10nship between psychological vulnerability and the psychological ~nd physical outcomes. . (rsles), state-trait anxiety inventory (stai), beck depr~ssi~n lnvento~ (bdi), and~ _21-item pbys~i symptoms inventory. we characterized participants as havmg psychological vulnerability and low resilience" as scoring above 35 on the raas (insecure attachment) or above 120 on the das (negative expectations about oneself). . . . . . " . . ,, . results: at baseline, 55% of parnc1pants were classified as havmg low resilience. focusmg on anxiety, the average cumulative stai score of the low-resilience group was significandy hi~e~ than that of the high-resilience group ( 18.45 sd= 10.6 versus 9.57 sd= 8.6; f(l,80)= 16.74, p <.001). similar results were obtained for bdi and physical symptoms (f( 1,80)= 14.65, p<.001 and f( 1,80)= 5.50, p<.05, respec· tively). after controlling for resilience, the effects of variance in life stres".°rs averaged over time wa~ a_sig· nificant predictor of depressive and physical symptoms, but not of anxiety. ho~e_ver, these assooan~s became non-significant when four participants with high values were removed. s1id1larly, after controlling for resilience, the effects of variance in social support averaged over time became insignificant. conclusion: not only did "low resilience" predict poor psychological and physical outcomes, it was also predictive of life events and social support; that is, individuals who were low in resilience were more likely to experience more life events and poorer social support than individuals who were resilient. for individuals with vulnerability to physical, psychological, and social outcomes, there is need to develop and test interventions to improve health outcomes in this group. rajat kapoor, ruby gupta, and jugal kishore introduction: young people in india represent almost one-fourth of the total population. they face significant risks related to sexual and reproductive health. many lack the information and skills neces· sary to make informed sexual and reproductive health choices. objective: to study the level of awareness about contraceptives among youth residing in urban and rural areas of delhi. method: a sample of 211 youths was selected from barwala (rural; n= 112) and balmiki basti (urban slums; n= 99) the field practice areas of the department of community medicine, maulana azad medical college, in delhi. a pre-tested questionnaire was used to collect the information. when/(calen· dar time), by 2, fisher exact and t were appliedxwhom (authors?). statistical tests such as as appropriate. result: nearly 9 out of 10 (89.1 %) youth had heard of at least one type of contraceptive and majority (81.5%) had heard about condoms. however, awareness regarding usage of contraceptives was as low as 9.4% for terminal methods to 39.3% for condom. condom was the best technique before and after marriage and also after childbirth. the difference in rural and urban groups was statistically signif· icant (p=.0001, give confidence interval too, if you provide the exact p value). youth knew that contra· ceptives were easily available (81 %), mainly at dispensary (68.7%) and chemist shops (65.4%). only 6.6% knew about emergency contraception. only advantage of contraceptives cited was population con· trol (42.6%); however, 3.8% believed that they could also control hiv transmission. awareness of side effects was poor among both the groups but the differences were statistically significant for pills (p=0.003). media was the main source of information (65%). majority of youth was willing to discuss a~ut contraceptive with their spouse (83.4%), but not with others. 51.2% youth believed that people in their age group use contraceptives. 35% of youth accepted that they had used contraceptives at least once. 81 % felt 2 children in family is appropriate, but only 59.7% believed in 3 year spacing. . conclusion: awareness about contraceptives is vital for youth to protect their sexual and reproduc· tive health .. knowledge about terminal methods, emergency contraception, and side effects of various contraceptives need to be strengthened in mass media and contraceptive awareness campaigns. mdbot:ls: 740 elderly aged 60+ were interviewed in 3 poor communities in beirut the capital of f:ebanon, ~e of which is a palestinia~. refugee camp. depression was assessed using the i 5-item geriat· nc depressi~n score (~l?s-15). specific q~estions relating to the 3 aspects of religiosity were asked as well as questions perta1rung to demographic, psychosocial and health-related variables. results: depression was prevalent in 24% of the interviewed elderly with the highest proportion being in the palestinian refugee camp (31 %). mosque attendance significantly reduced the odds of being depressed only for the palestinian respondents. depression was further associated, in particular communities, with low satisfaction with income, functional disability, and illness during last year. condiuion: religious practice, which was only related to depression among the refugee population, is discussed as more of an indicator of social cohesion, solidarity than an aspect of religiosity. furthermore, it has been suggested that minority groups rely on religious stratagems to cope with their pain more than other groups. implications of findings are discussed with particular relevance to the populations studied. nearly thirty percent of india's population lives in urban areas. the outcome of urbanization has resulted in rapid growth of urban slums. in a mega-city chennai, the slum populations (25.6 percent) face greater health hazards due to overcrowding, poor sanitation, lack of access to safe drinking water and environmental pollution. amongst the slum population the health of women and children are most neglected, resulting in burden of both communicable and non-communicable diseases. the focus of the paper is to present the epidemiology profile of children (below 14 years) in slums of chennai, their health status, hygiene and nutritional factors, the social response to health, the trends in child health and urbanization over a decade, the health accessibility factors, the role of gender in health care and assessment impact of health education to children. the available data prove that child health in slums is worse than rural areas. though the slum population is decreasing there is a need to explore the program intervention and carry out surveys for collecting data on some specific health implications of the slum children. objective: during the summer of 2003 there was a heat wave in central europe, producing an excess number of deaths in many countries including spain. the city of barcelona was one of the places in spain where temperatures often surpassed the excess heat threshold related with an increase in mortality. the objective of the study was to determine whether the excess of mortality which occurred in barcelona was dependent on age, gender or educational level, important but often neglected dimensions of heat wave-related studies. methods: barcelona, the second largest city in spain (1,582,738 inhabitants in 2003) , is located on the north eastern coast. we included all deaths of residents of barcelona older than 20 years that occurred in the city during the months of june, july and august of 2003 and also during the same months during the 5 preceding years. all the analyses were performed for each sex separately. the daily number of deaths in the year 2003 was compared with the mean daily number of deaths for the period 1998-2002 for each educational level. poisson regression models were fitted to obtain the rr of death in 2003 with respect to the period 1998-2002 for each educational level and age group. results: the excess of mortality during that summer was more important for women than for men and among older ages. although the increase was observed in all educational groups, in some age-groups the increase was larger for people with less than primary education. for example, for women in the group aged 65-74, the rr of dying for 2003 compared to 1998-2002 for women with no education was 1.30 (95%ci: 1.04-1-63) and for women with primary education or higher was 1.19 (95%ci: 0.90-1.56). when we consider the number of excess deaths, for total mortality (>=20 years) the excess numbers were higher for those with no education ( 17 5. 7 for women and 46. 7 for men) and those with less than primary education (112.5 for women and 11-2 for men) than those with more than primary edm:ation (75.0 for women and -10.3 for men). conclusion: age, gender and educational level were important in the 2003 barcelona heat wave. it is necessary to implement response plans to reduce heat morbidity and mortality. policies should he addressed to all population but also focusing particularly to the oldest population of low educational level. introduction: recently there has been much public discourse on homelessness and its imp~ct on health. measures have intensified to get people off the street into permanent housing. for maximum v132 poster sessions success it is important to first determine the needs of those to be housed. their views on housing and support requirements have to be considered, as th~y ar~ the ones affected. as few res.earch studies mclude the perspectives of homeless people themselves, httle is known on ho~ they e~penence the 1mpacrs on their health and what kinds of supports they believe they need to obtain housing and stay housed. the purpose of this study was to add the perspectives of homeless people to the discourse, based in the assumption that they are the experts on their own situations and needs. housing is seen as a major deter· minant of health. the research questions were: what are the effects of homelessness on health? what kind of supports are needed for homeless people to get off the street? both questions sought the views of homeless individuals on these issues. methods: this study is qualitative, descriptive, exploratory. semi-structured interviews were conducted with homeless persons on street corners, in parks and drop-ins. subsequently a thematic analysis was carried out on the data. results: the findings show that individuals' experiences of homelessness deeply affect their health. apart from physical impacts all talked about how their emotional health and self-esteem are affected. the system itself, rather than being useful, was often perceived as disabling and dehumanizing, resulting in hopelessness and resignation to life on the street. neither welfare nor minimum wage jobs are sufficient to live and pay rent. educational upgrading and job training, rather than enforced idleness, are desired by most initially. in general, the longer persons were homeless, the more they fell into patterned cycles of shelter /street life, temporary employment /unemployment, sometimes addictions and often unsuccessful housing episodes. conclusions: participants believe that resources should be put into training and education for acquisition of job skills and confidence to avoid homelessness or minimize its duration. to afford housing low-income people and welfare recipients need subsidies. early interventions, 'housing first', more humane and efficient processes for negotiating the welfare system, respectful treatment by service providers and some extra financial support in crisis initially, were suggested as helpful for avoiding homelessness altogether or helping most homeless people to leave the street. this study is a national homelessness initiative funded analysis examining the experiences and perceptions of street youth vis-a-vis their health/wellness status. through in-depth interviews with 140 street youth in halifax, montreal, toronto, calgary, ottawa and vancouver, this paper explores healthy and not-so healthy practices of young people living on the street. qualitative interviews with 45 health/ social service providers complement the analysis. more specifically, the investigation uncovers how street youth understand health and wellness; how they define good and bad health; and their experiences in accessing diverse health services. findings suggest that living on the street impacts physical, emotional and spiritual well·being, leading to cycles of despair, anger and helplessness. the majority of street youth services act as "brokers" for young people who desire health care services yet refuse to approach formal heal~h care organizational structures. as such, this study also provides case examples of promising youth services across canada who are emerging as critical spaces for street youth to heal from the ravages of ~treet cultur~. as young people increasingly make up a substantial proportion of the homeless population in canada, it becomes urgent to explore the multiple ways in which we can support them to regain a sense of wellbeing and "citizenship." p5-77 (c) health and livelihood implications of marginalization of slum dwellers in provision of water and sanitation services in nairobi city elizabeth kimani, eliya zulu, and chi-chi undie . ~ntrodfldion: un-habitat estimates that 70% of urban residents in kenya live in slums; yet due to their illegal status, they are not provided with basic services such as water sanitation and health care. ~nseque~tly, the services are provided by vendors who typically provide' poor services at exorbitant prices .. this paper investigates how the inequality in provision of basic services affects health and livelihood circumstances of the poor residents of nairobi slums . . methods: this study uses qualitative and quantitative data collected through the ongoing longitudmal .health and demographic study conducted by the african population and health research center m slum communities in n ·rob" w d · · · · ai 1. e use escnpnve analytical and qualitative techmques to assess h~w concerns relating to water supply and environmental sanitation services rank among the c~mmumty's general and health needs/concerns, and how this context affect their health and livelihood circumstances. results: water (32%) and sanitation (20%) were the most commonly reported health needs and also key among general needs (after unemployment) among slum dwellers. water and sanitation services are mainly provided by exploitative vendors who operate without any regulatory mechanism and charge exorbitantly for their poor services. for instance slum residents pay about 8 times more for water than non-slum households. water supply is irregular and residents often go for a week without water; prices are hiked and hygiene is compromised during such shortages. most houses do not have toilets and residents have to use commercial toilets or adopt unorthodox means such as disposing of their excreta in the nearby bushes or plastic bags that they throw in the open. as a direct result of the poor environmental conditions and inaccessible health services, slum residents are not only sicker, they are also less likely to utilise health services and consequently, more likely to die than non-slum residents. for instance, the prevalence of diarrhoea among children in the slums was 31 % compared to 13 % in nairobi as a whole and 17% in rural areas, while under-five mortality rates were 151/1000, 62/1000 and 113/1000 respectively. the results demonstrate the need for change in governments' policies that deprive the rapidly expanding urban poor population of basic services and regulatory mechanisms that would protect them from exploitation. the poor environmental sanitation and lack of basic services compound slum residents' poverty since they pay much more for the relatively poor services than their non-slum counterparts, and also increase their vulnerability to infectious diseases and mortality. since 1991 iepas've been working in harm reduction becoming the pioneer in latin america that brought this methodology for brazil. nowadays the main goal is to expand this strategy in the region and strive to change the drug policy in brazil. in this way harm reduction: health and citizenship program work in two areas to promote the citizenship of !du and for people living with hiv/aids offering law assistance for this population and outreach work for needle exchange to reduce damages and dissemination of hiv/aids/hepatit is. the methodology used in outreach work is peer education, needle exchange, condoms and folders distribution to reduce damages and the dissemination of diseases like hiv/aids/hepatitis besides counseling to search for basic health and rights are activities in this program. law attendance for the target population at iepas headquarters every week in order to provide law assistance that includes only supply people with correct law information or file a lawsuit. presentations in harm reduction and drug policy to expand these subjects for police chiefs and governmental in the last year attended 150 !du and 403 nidu reached and 26.364 needles and syringes exchanged. in law assistance 740 (420 people living with aids, 247 drug users, 43 inject drug users, 30 were not in profile) people attended. 492 lawsuits filed 218 lawsuits in current activity. broadcasting of the harm reduction strategies by the press helps to move the public opinion, gather supporters and diminish controversies regarding such actions. a majority number of police officer doesn't know the existence of this policy. it's still polemic discuss this subject in this part of population. women remain one of the most under seviced segments of the nigerian populationand a focus on their health and other needs is of special importance.the singular focus of the nigerian family welfare program is mostly on demographic targets by seeking to increase contraceptive prevalence.this has meant the neglect of many areas of of women's reproductive health. reproductive health is affected by a variety of socio-cultural and biological factors on on e hand and the quality of the service delivery system and its responsiveness on the other.a woman's based approach is one which responds to the needs of the adult woman and adolescent girls in a culturally sensitive manner.women's unequal access to resources including health care is well known in nigeria in which stark gender disparities are a reality .maternal health activities are unbalanced,focusi ng on immunisation and provision of iron and folic acid,rather than on sustained care of women or on the detection and referral of high risk cases. a cross-sectional study of a municipal government -owned hospitalfrom each of the 6 geo-political regions in igeria was carried out (atotal of 6 ce~ters) .. as _part ~f t~e re.search, the h~spital records were uesd as a background in addition to a 3-week mtens1ve mvesuganon m the obstemc and gynecology departments. . . . : little is known for example of the extent of gynecological morbtdtty among women; the little known suggest that teh majority suffer from one or more reproductive tr~ct infect~ons. although abortion is widespread, it continues to be performed under ilegal and unsafe condmons. with the growing v134 poster sessions hiv pandemic, while high riskgroups such ascomn;iercial sex workers and their clients have been studied, little has been accomplished in the large populat10ns, and particularly among women, regardmgstd an hiv education. . . conclusions: programs of various governmentalor non-governmental agen,c1es to mvolve strategies to broaden the narrow focus of services, and more importan~, to put wo~en s reproducnve health services and information needs in the forefront are urgently required. there is a n~d to reonent commuication and education activities to incorprate a wider interpretation of reproducnve health, to focus on the varying information needs of women, men, and youth and to the media most suitable to convey information to these diverse groups on reproductive health. introduction: it is estimated that there are 250-300 youths living on the streets, on their own with the assistance of social services or in poverty with a parent in ottawa. this population is under-serviced in many areas including health care. many of these adolescents are uncomfortable or unable to access the health care system through conventional methods and have been treated in walk-in clinics and emergency rooms without ongoing follow up. in march 2004, the ontario government provided the ct lamont institute with a grant to open an interdisciplinary and teaching medical/dental clinic for street youth in a drop-in center in downtown ottawa. bringing 5 community organizations together to provide primary medical care and dental hygiene to the streetyouths of ottawa ages 12-20, it is staffed by a family physician, family medicine residents, a nurse practitioner, 2 public health nurses, a dental hygienist, dental hygiene students and a chiropodist who link to social services already provided at the centre including housing, life skills programs and counselling. project objectives: 1. to improve the health of high risk youth by providing accessible, coordinated, comprehensive health and dental care to vulnerable adolescents. 2. to model and teach interdisciplinary adolescent care to undergraduate medical students, family medicine residents and dental hygiene students. methods: non-randomized, mixed method design involving a process and impact evaluation. data collection-qualitative:a) semi-structured interviews b) focus groups with youth quantitative:a) electronic medical records for 12 months b) records (budget, photos, project information). results: in progress-results from first 12 months available in august 2005. early results suggest that locating the clinic in a safe and familiar environment is a key factor in attracting the over 130 youths the clinic has seen to date. other findings include the prevalence of preventative interventions including vaccinations, std testing and prenatal care. the poster presentation will present these and other impacts that the clinic has had on the health of the youth in the first year of the study. conclusions: 1) the clinic has improved the health of ottawa streetyouth and will continue beyond the initial pilot project phase. 2) this project demonstrates that with strong community partnerships, it is possible meet make healthcare more accessible for urban youth. right to health care campaign by s.j.chander, community health cell, bangalore, india. introduction: the people's health movement in india launched a campaign known as 'right to health care' during the silver jubilee year of the alma ata declaration of 'health for all' by 2000 ad in collahoration with the national human rights commission (nhrc). the aim of the campaign was to establish the 'right to health care' as a basic human right and to address structural deficiencies in the pubic health care system and unregulated private sector . . methods: as part of the campaign a public hearing was organized in a slum in bangalore. former chairman of the nhrc chaired the hearing panel, consisting of a senior health official and other eminent people in the city. detailed documentation of individual case studies on 'denial of access to health care' in different parts of the city was carried out using a specific format. the focus was on cases where denial of health services has led to loss of life, physical damage or severe financial losses to the patient. results: _fourte_en people, except one who had accessed a private clinic, presented their testimonies of their experiences m accessing the public health care services in government health centres. all the people, e_xcept_ one person who spontaneously shared her testimony, were identified by the organizations worki_ng with the slum dwellers. corruption and ill treatment were the main issues of concern to the people. five of the fourteen testimonies presented resulted in death due to negligence. the public health cen· n:s not only demand money for the supposedly free services but also ill-treats them with verbal abuse. five of these fourteen case studies were presented before the national human right commission. the poster sessions v135 nhrc has asked the government health officials to look into the cases that were presented and to rectify the anomalies in the system. as a result of the public hearing held in the slum, the nhrc identified urban health as one of key areas for focus during the national public hearing. cond#sion: a campaign is necessary to check the corrupted public health care system and a covetous private health care system. it helps people to understand the structure and functioning of public health care system and to assert their right to assess heath care. the public hearings or people's tribunals held during the campaign are an instrument in making the public health system accountable. ps-82 (a) violence among women who inject drugs nadia fairbairn, jo-anne stoltz, evan wood, kathy li, julio montaner, and thomas kerr background/object ives: violence is a major cause of morbidity and mortality among women living in urban settings. though it is widely recognized that violence is endemic to inner-city illicit drug markets, little is known about violence experienced by women injection drug users (!du). therefore, the present analyses were conducted to evaluate the prevalence of, and characteristics associated with, experiencing violence among a cohort of female idu in vancouver. methods: we evaluated factors associated with violence among female participants enrolled in the vancouver injection drug user study (vidus) using univariate analyses. we also examined self-reported relationships with the perpetrator of the attack and the nature of the violent attack. results: of the 346 active iou followed between december 1, 2003 and may 6, 2005, 73 (21.1 %) had experienced violence during the last six months. variables positively associated with experiencing violence included: homelessness (or= 3.46, 95% ci: 1.66-7.21, p < 0.01), public injecting (or= 3.45, 95% ci: 1.43 -8.35, p < 0.01 ), frequent crack use (or= 2.99, 95% ci: 1. 72 -5.17, p < 0.01 ), recent incarceration (or =2.81, 95% cl: 1.38 -5.72, p < 0.01), receiving help injecting (or =2.77, 95% cl: 1.54-5.00, p < 0.01 ), shooting gallery attendance (or =2.46, 95% ci: 1.22 -4.93, p < 0.01 ), sex trade work (or =2.30, 95% cl: 1.35 -3.93, p < 0.01 ), frequent heroin injection (or= 1.96, 95% cl: 1.13 -3.40, p < 0.02), and residence in the downtown eastside (odds ratio [or] = 1.85, 95% ci: 1.09 -3.13, p < 0.02). variables negatively associated with experiencing violence included: being married or common-law (or =0.47. 95% ci: 0.25 -0.87, p < 0.02) and being in methadone treatment (or =0.53, 95% ci: 0.31 -0.91, p < 0.02). the most common perpetrators of the attack were acquaintances (48.0%), strangers (27.4%), police (9.6%), or dealers (8.2%). attacks were most frequently in the form of beatings (65.8%), robberies (21.9%), and assault with a weapon (13.7%). conclusion: violence was a common experience among women !du in this cohort. being the victim of violence was associated with various factors, including homelessness and public injecting. these findings indicate the need for targeted prevention and support services, such as supportive housing programs and safer injection facilities, for women iou. introduction: although research on determinants of tobacco use among arab youth has been carried out at several ecologic levels, such research has included conceptual models and has compared the two different types of tobacco that are most commonly used among the lebanese youth, namely cigarette and argileh. this study uses the ecological model to investigate differences between the genders as related to the determinants of both cigarette and argileh use among youth. methodology: quantitative data was collected from youth in economically disadvantaged urban communities in beirut, the capital of lebanon. results: the results indicated that there are differences by gender at a variety of ecological levels of influence on smoking behavior. for cigarettes, gender differences were found in knowledge, peer, family, and community influences. for argileh, gender differences were found at the peer, family, and community l.evels. the differential prevalence of cigarette and argileh smoking between boys and girls 1s therefore understandable and partially explained by the variation in the interpersonal and community envi.ronment which surrounds them. interventions therefore need to be tailored to the specific needs of boys and girls. introduction: the objective of this study was to assess the relationship between parents' employment status and children' health among professional immigrant families in vancouver. our target communmes v136 poster sessions included immigrants from five ethnicity groups: south korean, indian, chine~e, ~ussian, and irani~ with professional degrees (i.e., mds, lawyers, engineers, ma?~ger~, and uru~ers1ty professors) w11h no relevant job to their professions and those who had been hvmg m the studied area at least for 36 months. methodology: the participants were recruited by collaboration from three local community agencies and were interviewed individually during the fall of 2004. ra#lts: totally, 109 complete interviews were analyzed: 33 from south-east asia, 59 from south asia, 17 from russia and other eastern europe. overall, 14.5% were employed, 38.5% were underemployed, 46% indicated they were unemployed. overall, 58.5% were not satisfied with their current job. russians and other eastern europeans were most likely satisfied with their current job, while south-east asians were most satisfied from their life in canada. about 53% indicated that their spouses were not satisfied with their life in canada, while 55% believed that their children are very satisfied from their life in canada. in addition, around 30% said they were not satisfied from their family relationship in canada. while most of the responders ranked their own and their spouses' health status as either poor or very poor, jut 3% indicated that their first child's health was very poor. in most cases they ranked their children's health as excellent or very good. the results of this pilot study show that there is a need to create culturally specific child health and behavioral scales when conducting research in immigrant communities. for instance, in many asian cultures, it is customary for a parent either to praise their children profusely, or to condemn them. this cultural practice, called "saving face," can affect research results, as it might have affected the present study. necessary steps, therefore, are needed to revise the current standard health and behavioral scales for further studies by developing a new scale that is more relevant and culturally sensitive to the targeted immigrant families. metboda: database: 2003 national health survey (ministry of health www.msc.es). two thousand interviews were performed among madrid population (0.04% of the whole); 593 corresponded to older adults (0.04% of the 1. 7 million aged 50 years and over). study sample constitutes 95.3% (565 out of 593) of those older adults, who live in urban areas. demographic structure (by age and gender) of this population in relation to health services use (medical consultations, dentist visits, emergence services, hospitalisation) was studied using general linear model univariate procedure. a p0.005), while age was associated with emergence services use (26% of the population: 21 %, 28% and 45% of each age group) and hos~italisation (17% .oft~~ population: 13%, 20% and 31%, of each age ~oup) (p0.005) was fou~d with respect to dennst v1s1ts (18% vs 20%), medical consultations (29% vs 36%), and emergence services use (26% vs 26%), while an association (p= 0.005) was found according to hospitalisation (20% vs 16%). age. an~ g~der interaction effect on health services use was not found (p> 0.005), but a trend towards bosp1tal1sanon (p=0.04) could be considered. concl.uions: demographic structure of urban older adults is associated with two of the four health se~ices use studi~. a relation.ship ber_ween age. and hospital services use (emergence units and hospitalisanon), but not with ~ut-hosp1tal sei:vices (medical and dentist consultations), was found. in addition ro age, gender also contnbutes to explam hospitalisation. . sexua experiences. we exammed the prevalence expenences 10 relation to ethnic origin and other sociodemographic variables as wc1i as y1j7 die relation between unwanted sexual experiences, depression and agreuion. we did so for boys and prts separately. mdhods: data on unwanted sexual expcric:nces, depressive symptoms (ce.s-d), aggrc:uion (bohi-di and sociodemographic facron were collected by self-report quescionnairc:s administettd to 35 31 students in the: 2nd grade (aged 12-16) of secondary schools in amsterdam, the netherlands. data on the nature ol unwanted sexual experiences were collected during penonal interviews by trained schoolnursn. ltaijtj: overall prevalences of unwanted sexual experiences for boys and girls were 6.5% and 5.7% respectively. unwanted sexual experiences were more often ttported by turkish ( 17.1 %), moroc· an (10.4%) and surinamese/anrillian boys (7.4%) than by dutch boys (2.2%). moroccan and turkish girls, however, reported fewer unwanted sexual experiences (respectively 2.3 and 2.7%) than durch girls did (6.9%). depressive symptoms(or=4.6, cl=3.1-7.0) covert agression (0r•4.9, cl•3.2-7.7) and cmrt aggression (or= 2.6, cl• 1.6-4.4) were more common in girls with an unwanted sexual experi· met. boys with an unwanted sexual experience reported more depressive symptoms (or= 2.2; cl• i . .l· 3.9) and oven agression (or= 1.5, cl= 1.0-2.4) . of the reported unwanted sexual experiences rnpec· timy 17.5% and 73.5% were confirmed by male and female adolescents during a personal interview. cond11sion: we ..:an conclude that the prevalence of unwanted sexual experiences among turkish and moroccan boys is disturbing. it is possible that unwanted sexual experiences are more reported hy boys who belong to a religion or culture where the virginity of girls is a maner of family honour and talking about sexuality is taboo. more boys than girls did not confirm their initial disdosurc of an lllwalltc:d sexual experience. the low rates of disclosure among boys suggcsu a necd to educ.:atc hcahh care providen and others who work with migrant boys in the recognition and repomng of 1exu.il ... iction. viramin a aupplc:tmntation i1 at .h'yo, 1till far from tafl'eted 100%. feedinit pracn~:n panku· lerty for new born earn demand lot of educatton ernpha111 a• cxdu11ve hrealt fecdtnit for dnared rcnoj of 6 months was observtd in only 6.s% of childrrn thoulh colckturm w.11 givm 1n rn% of mwly horn ct.ildrm. the proportion of children hclow-2 waz (malnounshrdl .con" a• h!jh •• 42.6% anj "rt'i· acimy tc.. 11 compared to 1998 data. mother's ~alth: from all is 10 womm in ttprod~uvr •ill' poup, 83% were married and among marned w~ .\9% only w\"rt' u1mic wmr cnntr.-:cruve mt1h· odl 44% were married bdorc thc •ar of 18 yean and 27% had thnr ftnc prcicnancy hcftitt dlt' •icr nf 21 yean. the lt'f'vicn are not uutfactory or they arc adequate but nae unh1ed opumally. of thote' l'h mothen who had deliverrd in last one year, 80% had nailed 11ntmaral eum1nat1on 11 ira" oncc, .~o-... bad matt rhan four ttmn and ma1ortty had 1heir tetanus toxotd tnin,"t1or"'" nlht "'"'"· ljn1r11ned rn· win ronductrd 12.4% dchvcnn and 26% had home deh\'t'oc'i. ~md~: the tervtcn unbud or u111led are !tu than dnarame. the wr· l'kft provided are inadequate and on dechm reprcwnttng a looun1t ~p of h11hnto good coytti\#' ol wr· ncn. l!.ckground chanpng pnoriry cannoc be ruled out u °"" of thc coatnbutory bc10f. ps-ii ia) dcpn:wioa aad anuccy ia mip'mu ia awccr._ many de wn, witco tui~bmjer. jack dekker, aart·jan lttkman, wim gonmc:n. and amoud verhoeff ~ a dutch commumry-bucd icudy thawed 12-moarh•·prc:yalm«i al 17 .44'1. kw anx1· ay daorden and 13. 7% foi' dqrasion m anmttdam. nm .. 11p1tficantly hlllhn than dwwhrft .. dw ~thew diffamca m pttyalcnca att probably rdarcd to tlk' largr populanoa of napaan 111 ..\mturdam. <turkish 5%, moroccan 9%, and surinam 10%1. lndttd. ic'wt'll ltudla hatt ~ ~ high prevalena rata among migrant poupi in rbe ncdwrlands. howc'ytt au ttlluchn iuffenod from wry low raporne rara, or med screnung talel thac lack a ~y yabdarcd ~ in order to study the prevalence of depression and anxiety, and the (barriers to) use of mental health care among the different ethnic groups the following study was recently conducted: . the study consisted of a two-step approach. the first step was mcl~ded m the ~ h ith survey of 2004 (ahs), and consisted of three screening scales for depression and aruaety (klo, g::q-12 and mhl-5). in this survey all respondents were asked_ permission for~ second app~ 1:' 18t consisted of a structured interview containing the cidi for aruaety and depression, and questtollllalres on health care seeking, amongst others. all respondents who gave permission for a second approachwere invited by jetter for a suuctured interview with multilingual interviewers at home at a preset date and time in the following week. . in total, 439 dutch, 317 turkish, 322 moroccan and 124 surinam respondents took part in the ahs and gave permission for a second approach. in the second step, fo~ 21~ tur~h, 184m~roc can 87 surinamese and 320 dutch respondents, information from the extensive interview was available (res~nse rates between 60 and 70% ). since the data collection was completed only recently (june 2005), prevalence estimates can be presented at the conference for the first time. we have shown that with this approach it is feasible to achieve an acceptable response rate in a study on mental health among migrants. therefore we expect that this study will provide reli· able estimates of depression and anxiety in the turkish, moroccan and surinam migrants in amstw!3~· for the first time. in addition, insight into mechanisms underlying the differences between and within ethnic groups and into barriers to mental health care will provide pretexts for the improvement of pre· vention and mental health care for migrant groups. this study aimed to determine spatial patterns of mortality and morbidity of five major health problems in an urban environment: homicides, pregnancy among adolescents ((<20 years old), asthma hospitalization among young children(< 5 years old) and two mosquito-borne diseasesdengue and visceral leishmaniasis, during 1999-2003. all events were obtained through the city health database and, subsequently, geoproccsscd using the address of residence and the geographical and administrative division of the municipality, composed by 80 unit of planning (up), which in tum were formed, each one, by census tract units. two research questions were investigated: are there spatial patterns to the events dis· tribution, and moreover, are these patterns overlapping across space? we use thematic maps, index of comparative mortality/morbidity by up and the overlapped rank of the 20th worse up rates for each event. a spatial pattern of high rates of homicides, proportion of young mothers and hospitalization of asthma were overlapping in areas social and economically disadvantaged. for mosquito-borne diseases, high rates with great dispersion were found in unprivileged areas in contrast with very low rares among privileged ones. these results pointed toward a coexistence of heavier burden of diseases for those living in areas of the city where misery, poverty, lack of political public health may be modulating social health problems. a possible environmental intervention in one mosquito•bome disease might be playing a role in the occurrence of other. although with limitations, this study may provide useful information for a joint urban planning under the public perspective, articulated for use in health impact assessment. jalil safaei bdrod#aion: the association of socioeconomic status (ses), usually measured by income, and health status is an established result in bcalth studies. the poor and low income individuals have lower health sta· tus then_ those with higher incomes. in general. such finding has been usually obtained from sample surveys on speafic populations. a problem with many sample survey$ is that their results are not comparable aaoss ~ndaries as they may use different sampling methods, ask different questions, categorize the answers differently, or define groups differently. moreover, the sample data need to be standardized using the demographic: katurea of a ~ population. this study, however, uses the national population health survey (nphs) cycle 3 public use mictodata files which is based on a common survey template ·~~three~ area in canada, namely montreal, toronto, and vancouver. it also utili7.es the built-m stanclatdizaaon of the nphs data which accounts for its complex survey design. . ~:the stu~ usc:s two well-known measures of health inequalitythe relative index of meqaality and die concentranon indexto capture the extent of income related health inequality among poster sessions v139 urban female and male populations in each of the three metropolitan areas. personal income is classified into ten groups by the nphs with "no income" as the first group and "more than $60,000" as the last. health status is measured by three variables -having a chronic condition (chc), self assessed health (sah), and health utility index (hui) -using appropriate indices. alternative formulations are used to calculate the standard deviations of the estimated or calculated measures. the findings of the study suggest that the measured health inequality depends on the health measure used. for chc and hui the measured inequality indices do indicate poorer health for lower income individulas, however, they are not statistically insignificant. health inequalities are more pronounced when health is measured by sah. the results do not support any systematic ranking of the three metropolitan areas in terms of health inequalities. they do not reveal any systematic pattern of inequality between men and women, either. conclusions: despite the use of highly aggregated nphs data, income related health disparities are observed in the three metropolitan areas in canada. this is more the case with self perceived (sah) health. such disparities are preventable and call for broader health policies that address poverty and low income among other social determinants of health. introduction: the analysis of health indicators under the spatial perspective is configured as an important instrument in the detection of intra-urban differentials. this study aimed to examine the spatial distribution of the births occurred in belo horizonte, in 2001, analyzing the presence of spatial clusters of health indicators for newborns (rn) and their mothers, using data from the information system on live birth database (sinasc). method: for each covered area of the basic units of health (ubs), we calculated the proportion of: adolescent mothers, mothers with less than 8 years of schooling, first pregnancy, mothers with four or more pregnancies, dead babies born on previous pregnancies, stillbirths, cesarean section, less than four prenatal care attendance, moderate and severe hypoxemia in the 1st and 5th minutes of life, low or very low birth weight. we used empiric bayesian methods for smoothing the estimates. for spatial analysis, the indicators obtained from the global moran (i) index and local indicators of spatial association (lisa) were used. maps were built to allow the visualization of the spatial clusters. in all analysis, significance statistics was considered p~ 0.05. results: a total of 36, 12 7 births of residents in belo horizonte were registered in 200 i. the estimated bayesian proportions for the entire municipality was close to the one observed for all variables. analysis using lisa showed the presence of relevant spatial clusters for adolescent and low educated mothers, dead babies form previous pregnancies, cesarean section, low attendance to the prenatal care especially in area with low socio-demographic characteristics. three areas presented consistent clusters, with important spatial auto-correlation for almost all studied indicators. conclusion: the used methodology was configured as a great instrument of detection risk areas where clustering occurs. it can easily be incorporated in any surveillance system as a mechanism for controlling events related to births in the municipality. moreover, it can be applied to discriminate target areas for prompt public health interventions, such as improving health services access and the consolidation of better obstetric practices. introduction: gentrification, the displacement of low income and non-majority people out of longtime neighborhoods and residences is a global phenomenon. it has been identified as occurring in both developed and less developed countries and as inequality persists or increases, many communities are vulnerable to disruption and loss. while there may be some benefits to gentrification, these benefits are less likely to impact those who have been forced to move out of a gentrifying community or those who remain but economically stressed. . . . . this paper lays out a theoretical framework for 1dent1fymg and ~ddressm~. the_ health consequences of gentrification on residents living in a community prior .to o.r durmg gent~1~1cat.10n. by drawing on the literature of housing, sociology, health and urban plannmg, 1t places genmf1catt~n and neighborhood change into the context of other forces affecting th~ .hea.lth of vulnerable populations. it then proposes solutions to prevent or mitigate the impacts of genmf1cat1on. results: four main categories of consequences potentiallr re~ult from ~entr~fica~~n: !'°°r housing· related issues, spatial effects, mental health impacts and contr1bunons to racial ~spanttes m heal~. the housing issues include increased susceptibility to asthma, lead exposure, allergiesl~topy an~. acetdents/ injuries. spatial effects include reduced access to health ~are, reduce~ access to 1obslttadinonal food sources, decreased physical activity, and increased obesity. the __ pnmary mental health effects_ :ire increased stress increased risk of depression and disruption of trad1t1onal support networks. in addinon to the above he~lth issues, gentrification has the potential to increase racial disparities in health by reduc· ing access to long term and multi-culturally experienced health care provide~s. conclusions: public health practice provides a framework for addressmg the health consequences of gentrification. in this context primary prevention would involve preventing gentrification in the first place along with a renewed commitment to helping distressed communities a~~ im_proving the quality ~f life for long term residents. the next layer of meeting the challenges of gentrification would be to assjst long rime residents to stay in a community and thus potentially allowing them to participate in the bene~ts of gentrification (such as better public services). only if all these efforts fail -and these other prevennon strategies must be a priority, public policy should then work to help people and instirutions move to other communities through grants and the provision of alternative safe affordable housing and neighborhoods. sarah romans, marsha cohen, and tonia forte lnh'odlletion: there has been sustained interest in urban rural (ur) differences in mental health over the last 50 years of epidemiological research, with most studies reporting higher urban rates of mor· bidity, particularly when psychotic disorders have been studied. most recently, in britain, urban rates of non-psychotic disorder were greater than rural and semi-rural rates, both before and after the more adverse circumstances of urban dwellers were considered (paykel et al 2003) . surprisingly, there were no ur differences in help seeking. in canada, wang (2004) found greater urban rates for major depression only after he controlled for the confounding effects of race, immigration, employment and marital status, a result reminiscent of work from the us (blazer et 1985) . rural participants were less likely to have sought help for their mental health problems. in this study, we sought to examine urban/rural differences in rates of depression and help seeking in canada. method; data came from the 2000 canadian community health survey 1.2, a community survey conducted by statistics canada of people aged 15 and older, with the total sample size of 36,984 respon· dents, 77% response. analyses used weighted data; differences were assessed by chi-squared. ra.its: bivariate cross-tabulations showed a modest increase in 12 month depression rates for urban (5.4%) over rural (4.3%, p= 0.03) dwellers; there were no ur differences when the sample was examined separately by gender and age group ( 15-29, 30-44, 45-69) . in general, more urban (10.6%) than rural people (8. 7%, p= 0.002) had sought mental health treatment in the past year. there was no ur difference in helping seeking amongst those with depression (u 58.9%, r 50.1 % ns). amongst the whole population, helping seeking was gendered with more urban men accessing help (7.4%) than rural men (5.4%, p=0.004); this did not apply for women (13.7% vs 12.1% p=0.1). ~ons: the urban-rural demographic continues to generate intriguing findings, even recently when internal migration is common and people can seek out the environment most conducive to their health, ~th physical and mental. people with depression are a disadvantaged, frequently stigmatized group, with ~r quality of life a_nd often impaired function. unlike many other factors associated wi~h urban or rural hfe per se, depression can be treated. the low help seeking rates is a cause for concern, m both the ur~n and_ rural populations. it behooves researchers, policy makers and service planners to ensutt effective services are available for both humane and economic reasons. methods: using united states 2000 census income data, we assigned the 12 manhattan community districts to two major socioeconomic groups, manhattan i and ii. manhattan i is composed of community districts with average household incomes above the median for new york city; manhattan ii is those below. with public new york city department of health 1999 death records and 2000 us census data, we calculated a "standard" new york city population and estimated mortality rate distributions for manhattan i and ii. we then compared these age-adjusted actual mortality distributions with a standard t-test. results: we explored premature deaths using several cut-off points (before the ages of 65, 70, and 75), and with subcomparisons for males and females. every comparison showed the wealthier area, manhattan i, to have significantly lower premature mortality rates than the lower income manhattan ii. further, we compared age-adjusted mortality rates among the city's five boroughs, and found no significant differences based on local geography alone. conclusions: these findings suggest that in manhattan, characterized by its extremes of wealth and poverty, health status, as measured by premature mortality, does vary significantly with the local income level. in manhattan, the relative average income by community district varies as much as 4: 1. this ratio is greater than that found in the other cities we have studied: for example, the range among tokyo's kus is half that in manhattan, or about 2: 1. paris has shown the longest life expectancy and changing premature mortality rates. from our preliminary work, we expect to find less variation in premature mortality rates in comparable cities. this study will continue to explore the relationship of premature mortality rates and life expectancy to income levels and different health systems among wcp cities with a view to measuring health policy options. introduction: according to the world health organization (who), smoking-related illness is currently the world's second major cause of death, currently responsible for one out of ten adult deaths worldwide. the who's framework convention on tobacco control (fctc) aims to reduce tobaccorelated disease and deaths by changing national public policies. mexico, which, according to the who, had smoking prevalences of 32% among adults in 1998 and 23% among health care providers (hcps) in 1997, ratified the fctc in 2004. objective: to examine knowledge of and attitudes towards cigarette smoking and smoking cessation among hcps, and clinical practices regarding smoking cessation. methods: in june 2005, a convenience sample of hcps from one public clinic in urban oaxaca, mexico, part of mexico's national network of public health care clinics, were interviewed in spanish using a verbally administered questionnaire that was standard among all participants. during primary care outpatient visits, hcps were observed treating patients to assess the relative importance of smoking cessation as a health care priority. results: of the 18 hcps interviewed, including ten physicians, three nurses, and five medical students, 67% reported smoking regularly. all hcps reported assessing patients' history of smoking, knowledge of the health risks associated with smoking, and feeling qualified to discuss these risks with patients. all hcps reported counseling patients who currently smoked to quit. all hcps reported recommending nicotine replacement therapy (eg., patch and/or gum) and/or behavioral therapy (eg., psychologist, support groups) to patients who smoked. all hcps reported that there was no government funding for smoking cessation, and that all costs associated with smoking cessation were patients' out-of-pocket expenses. observation of hcp interaction with patients revealed that hcps always inquired about smoking history with new patients and rarely inquired about smoking history with returning patients. hcps were not observed counseling patients who reported current smoking on smoking cessation methods and its benefits. observation of the clinical environment suggested a focus on preventative child health (eg., immunization, water-borne illnesses), family planning, and chronic diseases (eg., diabetes, hypertension). conclusions: while the mexican government has made smoking cessation a public health priority and hcps report addressing smoking cessation, observation of hcps suggests: 1) smoking status is assessed only in new patients; and 2) smoking cessation methods are not addresse~. observ_atio~ of hcps and the clinical environment in a public clinic in oaxaca suggests that smoking cessation 1s of lower priority than other heath care issues. p6-04 (a) urban agriculture and food and nutrition security in kampala, uganda fiona yeudall, renee sebastian, abdelrahman lubowa, selahadin ibrahim, and donald cole introduction: urban agriculture is an important livelihood strategy contributing to household food security by increasing access and availability to food in urban settings (koc et al., 1999) . the purpose of poster sessions v142 rhis study was to examine relationships between child nutritional securiry outcomes, household food security, and urban agriculture activiries in kampala, uga~da. . . questionnaires assessing socio-demographic, farmmg and household food secunry (hfsi characreristics were administered to 270 households. food diversiry was ~lculate~ from ~e number of foods consumed over 24 hours for one child (2-5 years) per household. heigh~ weight,. nud-upper·ann· circumference (muac) and tricep skinfolds (tsf) were measured for the mdex child. z-sc.ores for height-for·age (haz), weighr-for-age (waz) and body mass index (zbmi) were ~~ulated usmg cen· rres for disease control and prevenrion reference data. z-scores for body composition measures were calculated using nhanes i and ii data for african americans. the lms method was used to c~.t for skewed z·score indices. all dara was checked for normaliry and univariable and backward mulnvanablc linear regression analysis conducted. ruwlts: household food securiry was significantly associated with wealth (b= 0. 71, p< 'a acre were more dependenr on assets for hfs. although sex of head of household was ~ot related to j-:ifs, it modi· fied relationships in rhar female headed households had greater food securtry when fai:mmg less than 1,4 acre compared ro male headed households, and vice versa. hfs was significantly associated with food diversiry (s=0.15, p). urbanization, especially in developing countries, has substantially increased the vulnerability of rhe mass of low-income urban dwellers. the livelihoods and quality of life for many of the poor espe· cially in larin america, asia, and africa, have deteriorated significantly over the years. urban areas are increasingly unable to provide for their populations, resulting in poverry, massive unemploymenr, job cuts, poor housing, lack of or poor public services, and a compromised health status. botswana, a country rhat lies in the sourhern parr of africa, has had its share of urban problems such as rhe mush· rooming of squarters and low-income urban sertlements. despite efforts to address the substandard living conditions in low-income urban areas, these problems have continued to grow. these living con· diuons are porenrially stressful to rhe residenrs and likely affects their health. the primary aim of the 11udy wa1 to examine the complex relationship between communiry-level stressors and interveners and health-related quality of life among residents of low-income neighborhoods in francistown, botswana. u1i"" a croa1-icctional quantitative design (both descriptive and explanatory) and using primarily cloae-mded interview• with a random sample of 388 residents, this study examined the role of chrome life 1trnson and environmental quality on overall health status qualiry of life) and the physical, psy· chological and level of independence domains of health. the major hypothesis of the study was that community-levrl stre1sor1 would influence health-related quality of life and that social capital would moderate these relationships. findings indicate that neighborhood quality is a powerful predictor of healrh 1tatu1 rhan socioeconomic status and individual life stressors. social capital was also found to he a 11111ificant positive predictor of healrh and also moderator of structural factors. social capital moderated the effects of low environmental quality on level of indrpendence and on physical health outcomn, but nor on psychological and global health outcomes. these findings suggest that as the environment get1 betttr. stresson are reduced, hence promoting berter health outcomes. the study ends with implication• for social justice, public health and social work practice, and research, focusing mostly on the ~ole of social capital and the environmental quality in predicting health outcomes. spt· cafically • anenhon should be focused on political and civic society's commitment for social justice and poveny alleviation, ~uction of the threat of insecuriry and violence; cultivating social capital and good governance; and improving the health and social environments, especially housing and environ· mental 1aiutanon to name a few. urban and other uprisings by non-elites that lead to transitions, can disrupt sexual and injection "risk" networks that transmit infectious diseases by changing mixing patterns. they can also weaken urban social networks, their associated protective norms and their informal social control mechanisms which can lead to increased sexual and drug risk behaviors and violence (fullilove 2004; wallace & wallace1998, aral 2002 , friedman & reid 2000 hankins et al 2002) . for example, the 1979 revolution and transition to theocratic rule, and subsequent urban and national conflicts, have been followed by many urban youth in iran engaging in clandestine high-risk sexual and drug behaviors. in palestine, conflicts and restrictions on movement have led to increased fatalities from chronic diseases due to limited access to hospitals and modern medical facilities (union of palestinian medical relief committees); and heroin use and violence-related blood exposure have also increased. social movements "from below" that are rooted both in urban social network dynamics and in underlying patterns of injustice can have both protective and risky effects. for example, the social movements that led to the collapse of the ussr and its dependent governments in other countries-with subsequent increases in sex trade, alcoholism, drug use, tuberculosis, hiv, stis, and mortality in many localities-were based originally on such city-based movements in eastern europe. their impacts on health were mediated by urban social dynamics and structures. some urban social movements have improved health by prevent· ing the spread of hiv, hepatitis and other diseases. examples include movements of (a) gays and lesbians and (b) drug users. these have been rooted in social networks that overlap with risk networks. theories of urban health should include social conflict as a core concept. mechanisms that generate conflicts and the pathways by which conflicts affect health should be a major part of urban health research agendas. p6-07 (c) demographic characteristics of people seen with tuberculosis in lagos state university teaching hospital (lasuth) chest clinic john bako, adewale akeredolu, and wale alabi tuberculosis has become a resurgent public health problem in recent times in the world. because resources are limited, control programmes frequently must target population at greatest risk. the purpose of this study was to study the demographic characteristics of people seen with tuberculosis in lagos state university teaching hospital. a total of 76 patients who have been both radiologically and bacteriologically confirmed tuberculosis patients were used for this study between january and march. 57 (75%) were males, while 19 (25%) were females. notable risk factors among patients with tuberculosis were overcrowding (46.1 % ), homelessness ( 11.8%) cigarette smoking (22.4% ), alcoholism (30.3%), non vaccination (25%), secondary contact (36.8%) and poor knowledge (92. l 'x,). man· agement history patterns among the patients were herbs ( 13.2 'yo), orthodox medicine ( .h . .l'x.). intervention targeting early-identified groups may be an effective way to reduce the incidence of tuber· culosis. such intervention should focus on health education, modification of life style and improvement of standard of living. p6-08 (c) profiles in urban health in 9 cities of the americas in the countries of the americas, there is an increasing migration of national and international populations to urban centers. this presentation will focus on some of the issues created by this influx of populations, the ways that 9 cities in 8 countries are dealing with them, and the efforts to promote local participation and solutions in management and decision-making. the methodology used to collect this information has been to draw upon and analyze information produced by the mayor's and ministry of health and development offices in each of the cities under consideration. an analysis of the impact of urbanization on health and health determinants will be presented. the information covers issues such as health status by geographic areas within the cities, highlighting issues such as marginality, barriers and physical, economic and cultural constructs and inequities in the delivery of and access to essential services (such as health, education, water, and basic sanitation). issues of governance and citizen participation will be highlighted to provide insight in~o the balance of power and mechanisms for decision-making at the local level. part of the analysis will show the relationship between democratic processes and social participation. public ~olicies will be reviewed to indicate those that are most beneficial in promoting health and overcoming barriers to it, as well as ways of capitalizing on local assets and resources. final~y, evidence of effectiveness of various strategies will be indicated. the presentation will conclude wuh suggesuons for future strategic directions to improve the quality of life and the promotion of health in large urban centers of the americas. introduction: much of the illicit drug in mexico is concentrated in northern border areas. the 2000 mile border between the u.s. and mexico is also characterized by migration; the border crossing between tijuana, baja california, mexico and san diego, california, u.s.a. is rep~rt~dl~ the busiest land border crossing in the world. we attempt to describe the migration scene among m1ect1on drug users (idus) m tijuana and investigate service needs. methods: migration trends were investigated in a cross-sectional study conducted from february to june 2005 among idus in tijuana. enrollment criteria included informed consent, being 18 years or older, and having injected drugs within the prior month. subjects were recruited by respondent-dnven sampling and were administered a quantitative survey and serology for hiv, hcv, and syphilis. logistic regression was used to compare idus who had migrated to the u.s. versus those who had not. results: of 222 idus enrolled, 91 % were male and median age and age at first injection were 35 and 20, respectively. drug combinations injected most frequently in the past 6 months were heroin (35%1 and crystal methamphetamine mixed with heroin (53%). of those enrolled, 212 responded to quesnons on migration and drug treatment and were included in this analysis. although 76% had resided in tijuana for at least 5 years, 70% of users were born outside of baja california. working outside of mexico was common, with 38% working abroad in the last 10 years (94% in u.s.), and 17% in the past year. in the last 6 months, 10% of idus had crossed the border to the u.s., with 57% crossing at least once per month. those working outside of mexico in the past year were less likely to have ever received substance abuse treatment, [29% vs. 53%, or 0.38, ] and were marginally less likely to have received drug treatment in the past 6 months [6% vs. 18 %, or 0.28, 95% ci (0.06-1.2)]. drug use patterns, age and gender did not differ between migrants and non-migrants, although migrants were more likely to report being in need of substance abuse treatment (68% vs. 57%, respectively). conclusions: migration is common among idus in tijuana. maintaining drug treatment regimens and determining how to best target education and services to a highly mobile population pose challenges to officials on both sides of the border. these data underscore the need to develop coordinated binational prevention and treatment efforts. introduction: despite the expanding literature on the important role public policy plays in influencing the broader determinants of the public\'s health, profound differences exist among jurisdictions in rhe attention placed upon such activities. we take an international perspective on health by examining rhe d?minant public _health paradigms of canada, usa, uk, and sweden and exploring how these paradigms shape public health practice. _method: we carefully analyze governmental and public health agencies documents to discern ~he dommant para~igms driving public health approaches and practices. we also consider the unique paht1· cal and economic contexts within each nation and consider how these contexts drive public health pahcy and approaches. . . ~u~: the canadian and usa public health communities -with some exceptions --focus upon m~ividuahzed approaches to risk management. in contrast, the uk and swedish public health scenes are oriented toward broader approaches to health determinants. we find that the extent to which govern· ments, public health agencies and public health workers concern themselves with public policy approaches £<_> ~ddress ~ro.ad~r .determinants of health depends upon the particular health parad'.~ adhered. ~o withm each 1urisd1ctton. and whether a paradigm is adopted depends upon the ideologi~a and pol~ncal context of each nation. nations such as sweden that have a long tradition of public policies promonng social jus~ce an~ equity are naturally receptive to evolving population health concepts. '[he usa represen~ a ~bey en~ro~~t where such is~ues are clear!~ subordinate. ., our findings mdicate that there 1s a strong political component that influences pubh ~ealth a~proaches and practi~ within the jurisdictions examined. the implications are that those seek· m~ to raise the broader detennmants of the public's health should work in coalition to raise these issues with non-health organizations and age · ca d d th · badrgrollnd: in developed countries, social inequalities in health have endured or even worsened comparatively throughout different social groups since the 1990s. in france, a country where access to medical and surgical care is theoretically affordable for everyone, health inequalities are among the high· est in western europe. in developing countries, health and access to care have remained critical issues. in madagascar, poverty has even increased in recent years, since the country wenr through political crisis and structural adjustment policies. objectives. we aimed to estimate and compare the impact of socio· economic status but also psychosocial characteristics (social integration, health beliefs, expectations and representation, and psychological characteristics) on the risk of having forgone healthcare in these 2 dif· fercnt contexts. methods: population surveys conducted among random samples of households in some under· served paris neighbourhoods (n= 889) and in the whole antananarivo city (n= 2807) in 2003, using a common individual questionnaire in french and malagasy. reslllts: as expected, the impact of socioeconomic status is stronger in antananarivo than in paris. but, after making adjustments for numerous individual socio-economic and health characteristics, we observed in both cities a higher (and statically significant) occurrence of reponed forgone healthcare among people who have experienced childhood and/or adulthood difficulties (with relative risks up to 2 and 3.s respectively in paris and antananarivo) and who complained about unhealthy living conditions. in paris, it is also correlated with a lack of trust in health services. coneluions: aside from purely financial hurdles, other individual factors play a role in the non-use of healthcare services. health insurance or free healthcare seems to be necessary hut not sufficienr to achieve an equitable access to care. therefore, health policies must not only focus on the reduction of the financial barriers to healthcare, but also must be supplemented by programmes (e.g. outreach care ser· vices, health education, health promotion programmes) and discretionary local policies tailored to the needs of those with poor health concern .. acknowledgments. this project was supported by the mal>io project and the national institute of statistics (instat) in madagascar, and hy the development research institute (ird) and the avenir programme of the national institute of health and medical research (inserm) in france. for the cities of developing countries, poverty is often described in terms of the living standard~ of slum populations, and there is good reason to believe that the health risks facing these populations are even greater, in some instances, than those facing rural villagers. yet much remains to be learned ahour the connections between urban poverty and health. it is not known what percentage of all urban poor live in slums, that is, in communities of concentrated poverty; neither is it known what proportion of slum residents are, in fact, poor. funhermore, no quantitative accounting is yet available that would sep· arare the health risks of slum life into those due to a househoid•s own poverty and those stemminic from poveny in the surrounding neighborhood. if urban health interventions are to be effectively targeted in developing countries, substantial progress must be made in addressing these cenrral issues. this paper examines poverty and children's health and survival using two large surveys, one a demographic and health survey fielded in urban egypt (with an oversampling of slums) and the other a survey of the slums of allahabad, india. using multivariate statistical methods. we find, in both settings: ( 11 substan· rial evidence of living standards heterogeneity within the slums; (21 strong evidence indicating that household-level poverty is an imponant influence on health; and (3) staristically significant (though less strong) evidence that with household living standards held constant, neighborhood levels of poverty adversely affect health. the paper doses with a discussion of the implications of these findings for the targeting of health and poverty program interventions. p6-13 (a) urban environment and the changing epidemiological surfacr. the cardiovascular ~ &om dorin, nigeria the emergence of cardiovascular diseases had been explained through the concomitants o_f the demographic transition wherein the prevalent causes of morbidity and monality ~hangr pr~mmant infectious diseases to diseases of lifestyle or chronic disease (see deck, 1979) . a ma1or frustration m the v146 poster sessions case of cvd is its multifactural nature. it is acknowledged that the environment, however defined is the d · f · t' b tween agents and hosts such that chronic disease pathogenesis also reqmre a me 1an o mterac ion e . spatio-temporal coincidence of these two parties. what is not clear is which among ~ever~( potennal fac· · h b pace exacerbate cvd risk more· and to what extent does the ep1dem1olog1cal trans1· tors m t e ur an s ' . . . . tion h othesis relevant in the explanation of urban disease outlook even the developmg cities like nigeri~: thesis paper explorer these within a traditional city in nigeria. . . . the data for the study were obtained from two tertiary level hospitals m the metropolis for 10 years (1991) (1992) (1993) (1994) (1995) (1996) (1997) (1998) (1999) (2000) . the data contain reported cases of cvd in the two facilities for the period. adopting a series of parametric and non-parametric statistics, we draw inferences between the observed cases of cvds and various demographic and locational variables of the patients. findings: about 28% of rhe cases occurred in 3 years (1997) (1998) (1999) coinciding with the last year of military rule with great instability. 55.3% occurred among male. 78.8% also occurred among people aged 31-70 years. these are groups who are also likely to engage in most stressful life patterns. ~e study also shows that 63% of all cases occurred in the frontier wards with minor city areas also havmg their •fair' share. our result conformed with many empirical observation on the elusive nature of causation of cvd. this multifactoral nature had precluded the production of a map of hypertension that would be consistent with ideas of spatial prediction. cvd -cardiovascular diseases. mumbai is the commercial capital of india. as the hub of a rapidly transiting economy, mumbai provides an interesting case study into the health of urban populations in a developing country. with high-rise multimillion-dollar construction projects and crowded slums next to each other, mumbai presents a con· trast in development. there are a host of hi-tech hospitals which provide high quality care to the many who can afford it (including many westerners eager to jump the queue in their healthcare systems-'medical tour· ism'), at the same time there is a overcrowded and strained public healthcare system for those who cannot afford to pay. voluntary organizations are engaged in service provision as well as advocacy. the paper will outline role of the voluntary sector in the context of the development of the healthcare system in mumbai. mumbai has distinct upper, middle and lower economic classes, and the health needs and problems of all three have similarities and differences. these will be showcased, and the response of the healthcare system to these will be documented. a rising hiv prevalence rate, among the highest in india, is a challenge to the mumbai public healthcare system. the role of the voluntary sector in service provision, advocacy, and empowerment of local populations with regards to urban health has been paramount. the emergence of the voluntary sector as a major player in the puzzle of urban mumbai health, and it being visualized as voices of civil society or communiry representatives has advantages as well as pitfalls. this paper will be a unique attempt at examining urban health in india as a complex web of players. the influence of everyday socio·polirical-cultural and economic reality of the urban mumbai population will be a cross cutting theme in the analysis. the paper will thus help in filling a critical void in this context. the paper will thus map out issues of social justice, gender, equiry, effect of environment, through the lens of the role of the voluntary sector to construct a quilt of the realiry of healthcare in mumbai. the successes and failures of a long tradi· tion of the active advocacy and participation of the voluntary sector in trying to achieve social justice in the urban mumbai community will be analyzed. this will help in a better understanding of global urban health, and m how the voluntary sector/ngos fir into the larger picture. ba~und: o~er. half _of n~irobi's 2.5 million inhabitants live in illegal informal settlements that compose 5 yo of the city s res1dent1al land area. the majority of slum residents lack access to proper san· iranon and a clean and adequate water supply. this research was designed to gain a clearer understand· mg of what kappr · · · h f . . opnate samtanon means or the urban poor, to determine the linkages between gender, hvehhoods, and access to water and sanitation, and to assess the ability of community sanitation blocks to meet water and sanitation needs in urban areas. m~tbojs_: _a household survey, gender specific focus groups and key informant interviews were conducted m maih saba, a peri-urban informal settlement. qualitative and quantitative research tools were u~ to asses~ the impact and effectiveness of community sanitation blocks in two informal settlements. results ropna e samtarmn me u es not only safe and clean latrines, but also provision ° adequate drainage and access to water supply for cleaning of clothes and homes. safety and cleanliness poster sessions v147 were priorities for women in latrines. levels of poverty within the informal settlements were identified and access to water and sanitation services improved with increased income. environmental health problems related to inadequate water and sanitation remain a problem for all residents. community sanitation blocks have improved the overall local environment and usage is far greater than envisioned in the design phase. women and children use the blocks less than men. this is a result of financial, social, and safety constraints. the results highlight the importance a need to expand participatory approaches for the design of water and sanitation interventions for the urban poor. plans need to recognize "appropriate sanitation" goes beyond provision of latrines and gender and socioeconomic differences must be taken into account. lessons and resources from pilot projects must be learned from, shared and leveraged so that solutions can be scaled up. underlying all the challenges facing improving water and sanitation for the urban poor are issues of land tenure. p6-16 (c) integrating tqm (total quality management), good governance and social mobilization principles in health promotion leadership training programmes for new urban settings in 12 countries/ areas: the prolead experience susan mercado, faren abdelaziz, and dorjursen bayarsaikhan introduction: globalization and urbanization have resulted in "new urban settings" characterized by a radical process of change with positive and negative effects, increased inequities, greater environmental impacts, expanding metropolitan areas and fast-growing slums and vulnerable populations. the key role of municipal health governance in mitigating and modulating these processes cannot be overemphasized. new and more effective ways of working with a wide variety of stakeholders is an underpinning theme for good governance in new urban settings. in relation to this, organizing and sustaining infrastructure and financing to promote health in cities through better governance is of paramount importance. there is a wealth of information on how health promotion can be enhanced in cities. despite this, appropriate capacity building programmes to enable municipal players to effectively respond to the challenges and impacts on health of globalization, urbanization and increasing inequity in new urban settings are deficient. the who kobe centre, (funded by the kobe group( and in collaboration with 3 regional offices (emro, searo, wpro) with initial support from the japan voluntary contribution, developed a health promotion leadership training programme called "prolead" that focuses on new and autonomous structures and sustainable financing for health promotion in the context of new urban settings. methodology: country and/or city-level teams from 12 areas, (china, fiji, india, japan, lebanon, malaysia, mongolia, oman, philippines, republic of korea, tonga and viet nam) worked on projects to advance health promotion infrastructure and financing in their areas over a 9 month period. tools were provided to integrate principles of total quality management, good governance and social mobili1.ation. results: six countries/areas have commenced projects on earmarking of tobacco and alcohol taxes for health, moblization of sports and arts organizations, integration of health promotion and social health insurance, organizational reforms, training in advocacy and lobbying, private sector and corporate mobilization and community mobilization. results from the other six areas will be reported in 01..;obcr. conclusions: total quality management, good governance and social mobilization principles and skills are useful and relevant for helping municipal teams focus on strategic interventions to address complex and overwhelming determinants of health at the municipal level. the prolead training programmes hopes to inform other processes for building health promotion leadership capacity for new urban settings. the impact of city living and urbanization on the health of citizens in developing countries has received increasing attention in recent years. urban areas contribute largely to national economies. however, rapid and unplanned urban growth is often associated with poverty, environmental degradation and population demands that outstrip service capacity which conditions place human health at risk. local and national governments as well as multi national organizations are all grappling with the challenges of urbanization. with limited data and information available, urban health characteristics, including the types, quantities, locations and sources in kampala, are largely unknown. moreover, there is n? basis for assessing the impact of the resultant initiatives to improve health ~onditions amo~g ~o":1":1um ties settled in unplanned areas. since urban areas are more than the aggregation ?f ~?pie w~th md_1v1dual risk factors and health care needs, this paper argues that factors beyond the md1v1dual, mcludmg the poster sessions v148 · i d h · i · ment and systems of health and social services are determinants of the health soc1a an p ys1ca environ . of urban populations. however, as part of an ongoing study? ~s pape~ .addresses the basic concerns of urban health in kampala city. while applying the "urban hvmg conditions and the urban heal~ pen· alty" frameworks, this paper use aggregated urban health d~ta t~ explore the role of place an~ 111st1tu· tions in shaping health and well-being of the population m kampala by understanding how characteristics of the urban environment and specific features of the city are causally related to health of invisible and forgotten urban poor population: results i~dica~e that a .range o~ urb~n he~l~h hazards m the city of kampala include substandard housing, crowdmg, mdoor air poll.ut1on, msuff1c1ent a~d con· taminated water, inadequate sanitation and solid waste management services, vector borne .diseases, industrial waste increased motor vehicle traffic among others. the impact of these on the envtronment and community.health are mutually reinforcing. arising out of the withdra"'.al of city pl~nning systems and service delivery systems or just planning failure, thousands of people part1cularl~ low-mc~me groups have been pushed to the most undesirable sections of the city where they are faced with ~ va_r1ety ~f envj· ronmental insults. the number of initiatives to improve urban health is, however, growing mvolvjng the interaction of many sectors (health, environment, housing, energy, transportation and urban planning) and stakeholders (local government, non governmental organizations, aid donors and local community groups). key words: urban health governance, health risks, kampala. introduction: the viability of urban communities is dependent upon reliable and affordable mass transit. in particular, subway systems play an especially important role in the mass transit network, since they provide service to vast numbers of ridersseven of the 95 subway systems worldwide report over one billion passenger rides each year. surprisingly, given the large number of people potentially affected, very little is known about the health and safety hazards that could affect both passengers and transit workers; these include physical (e.g., noise, vibration, accidents, electrified sources, temperature extremes), biological (e.g., transmission of infectious diseases, either through person-to-person spread or vector-borne, for example, through rodents), chemical (e.g., exposure to toxic and irritant chemicals and metals, gas emissions, fumes), electro-magnetic radiation, and psychosocial (e.g., violence, workstress). more recently, we need to consider the threat of terrorism, which could take the form of a mass casualty event (e.g., resulting from conventional incendiary devices), radiological attack (e.g., "dirty bomb"), chemical terrorist attack (e.g., sarin gas), or bioterrorist attack (e.g., weapons grade anthrax). given the large number of riders and workers potentially at risk, the public health implications are considerable. methods: to assess the hazards associated with subways, a structured review of the (english) litera· ture was conducted. ruults: based on our review, non-violent crime, followed by accidents, and violent crimes are most prevalent. compared to all other forms of mass transit, subways present greater health and safety risks. however, the rate of subway associated fatalities is much lower than the fatality rate associated with automobile travel (0.15 vs. 0.87 per 100 million passenger miles), and cities with high subway ridership rates have a 36% lower per capita rate of transportation related fatalities than low ridership cities (7.5 versus 11.7 annual deaths per 100,000 residents). available data also suggest that subway noise levels and levels of air pollutants may exceed recommended levels. . ~: there is a paucity of published research examining the health and safety hazards associated with subways. most of the available data came from government agencies, who rely on passively reported data. research is warranted on this topic for a number of reasons, not only to address important knowled~ gaps, but also because the population at potential risk is large. importantly, from an urban perspecnve, the benefits of mass transit are optimized by high ridership ratesand these could be adversely affu:ted by unsafe conditions and health and safety concerns. veena joshi, jeremy lim. and benjamin chua ~ ~rban health issues have moved beyond infectious diseases and now centre largely on chrome diseases. diabetes is one of the most prevalent non-communicable diseases globally. 9 % of adult ¥151 benefit in providing splash pads in more parks. given the high temperature and humidity of london summers, this is an important aspect and asset of parks. interviewed parents claimed to visit city parks anywhere between 1 to 6 days per week. corrduion: given that the vast majority of canadian children are insufficiently active to gain health benefits, identifying effective qualities of local parks, that may support and foster physical activity is essential. strategies to promote activity within children's environments are an important health initiative. the results from this study have implications for city planners and policy makers; parents' opinions of, and use of city parks provides feedback as to the state current local parks, and modifications that should be made for new ones being developed. this study may also provide important feedback for health promoters trying to advocate for physical activity among children. introdt1clion: a rapidly increasing proportion of urban dwellers in africa live below the poverty line in overcrowded slums characterized by uncollected garbage, unsafe water, and deficient sanitation and overflowing sewers. this growth of urban poverty challenges the commonly held assumption that urban populations enjoy better health than their rural counterparts. the objectives of this study are (i) to compare the vaccination status, and morbidity and mortality outcomes among children in the slums of nairobi with rural kenya, and (ii) to examine the factors associated with poor child health in the slums. we use data from demographic and health survey representative of all slum settlements in nairobi city carried out in 2000 by the african population & health research center. a total of 3,256 women aged 15-49 from 4,564 households were interviewed. our sample consists of 1,210 children aged 0-35 months. the comparison data are from the 1998 kenya demographic and health survey. the outcomes of interest include child vaccination status, morbidity (diarrhea, fever and cough) and mortality, all dichotomized. socioeconomic, environmental, demographic, and behavioral factors, as well as child and mother characteristics, are included in the multivariate analyses. multilevel logistic regression models are used. l'nlimin11ry rest1lts: about 32 % of children in the slums had diarrhea in the two weeks prior to the survey, compared to 16% of rural children. these disparities between the urban poor anj the rural residents are also observed for fever (64% against 42%), cough (46% versus 20%), infant mortality (91/ 1000 against 76/1000), and complete vaccination (48% against 64%). preliminary multivariate results indicate that health service utilization and maternal education have the strongest predictive power on child morbidity and mortality in the slums, and that household wealth has only minor, statistically insignificant effects. conclruion: the superiority of health of urban children, compared with their rural counterparts, masks significant disparities within urban areas. compared to rural residents, children of slum dwellers in nairobi are sicker, are less likely to utilize health services when sick, and stand greater risk to die. our results suggest policies and programs contributing to the attainment of the millennium development goal on child health should pay particular attention to the urban poor. the insignificance of socioeconomic status suggests that poor health outcomes in these communities are compounded by poor environmental sanitation and behavioral factors that could partly be improved through female education and behavior change communication. introduction: historic trade city surat with its industrial and political peace has remained a center of attraction for people from all the comers of india resulting in to pop.ulatio~ explosio~ a~d stressed social and service infrastructure. the topography,dimate and demographic profile of the city 1s threat to the healthy environment. aim of this analysis is to review the impact of managemt'nt reform on health indicators. method: this paper is an analysis of the changing profile of population, sanitary infr~s~rucrure, local self government management and public health service reform, secondary health stat1st1cs data, health indicator and process monitoring of 25 years. . . health of entire city and challenge to the management system. plague outbr~ak (1994) was the turning point in the history of civic service management including p~blic ~e~lth service management. ~ocal self government management system was revitalized by reg~lar_ field v1s1ts o~ al~ cadre~, _decentraltzanon of power and responsibility, equity, regular vigilant momtormg, commumcanon facility, ream_approach and people participation. reform in public health service management was throu_gh stan~~rd1zed intervention protocol, innovative intervention, public private partnership, community part1c1panon, academic and service institute collaboration and research. sanitation service coverage have reached nearer to universal. area covered by safe water supply reached to 98%(2004) from 40% (1991) and underground drainage to 97% (2004) from 17% ( 1991) the overhauling of the system have reflected on health indicators of vector and water born disease. malaria spr declined to 1.23 (2004) from 23.06'yo(!991) and diarrhea case report declined to 1963(2004) from 3431 (2004). except dengue fever in 2002 no major disease outbreaks are reported after 1991. city is recipient of international/national awards/ranking for these achievements. the health department have developed an evidence and experience based intervention and monitoring system and protocol for routine as well as disaster situation. the health service and management structure of surat city have emerged as an urban health model for the country. introduction: the center for healthy communities (chc) in the department of family and com· munity medicine at the medical college of wisconsin developed a pilot project to: 1) assess the know· ledge, attitudes, and behaviors of female milwaukee public housing residents related to breast cancer; 21 develop culturally and literacy appropriate education and screening modules; 3) implement the developed modules; 4) evaluate the modules; and 5) provide follow-up services. using a community-based participatory research model the chc worked collaboratively with on-site nurse case management to meet these objectives. methods: a "breast health kick off event" was held at four separate milwaukee public housing sites for elderly and disabled adults. female residents were invited to complete a 21-item breast health survey, designed to accommodate various literacy levels. responses were anonymous and voluntary. the survey asked women about their previous physical exams for breast health, and then presented a series of state· ments about breast cancer to determine any existing myths. the final part gathered information about personal risk for breast cancer, the highest level of education completed, and whether the respondents h;td ever used hormone replacement therapy and/or consumed alcohol. responses were collected for descriptive analysis. results: a total of 45 surveys (representing 18% of the total female population in the four sites) were completed and analyzed. 89% reported that they had a physical exam in the previous rwo years. 96% of respondents indicated they never had been diagnosed with breast cancer. 85% reported having had a mammogram and 87% having had a clinical breast exam. those that never had a mammogram reported a fear of what the provider would discover or there were not any current breast problems ro warrant an exam. 80% agreed that finding breast cancer early could lower the chance of dying of cancer. over 92% reported that mammograms were helpful in finding cancer. however, 27% believed that hav· ing a mammogram actually prevents breast cancer. 14% indicated that mammograms actually cause cancer and 16% reported that a woman should get a mammogram only if there is breast cancer in her family. conclusion: this survey indicates that current information about the importance of mammograms and clinical breast exams is reaching traditionally underserved women. yet there are still critical oppor· tunities to provide valuable education on breast health. this pilot study can serve as a tool for shaping future studies of health education messages for underserved populations. located in a yourh serv· ~ng agency m downtow~ ottawa, the clinic brings together community partners to provide primary medical care. and dent~i hygiene t? the street youths of ottawa aged 12-20. the primary goal of the project is to provide accessible, coordinated, comprehensive health and dental care to vulnerable adolescents. these efforts respond to the pre-existing body of evidence suggesting that the principle barrier in accessing such care for these youths are feelings of intimidation and vulnerability in the face of a complex healthcare system. the bruyere fhn satellite clinic is located in the basement of a downtown drop-in and brings together a family medicine physician and her residents, a dental hygienist and her 2nd year students, a nurse practitioner, a chiropodist and 2 public health nurses to provide primary care. the clinic has been extremely busy and well received by the youth. this workshop will demonstrate how five community organizations have come together to meet the needs of high risk youths in ottawa. this presentation will showcase the development of the clinic from its inception through its first year including reaction of the youths, partnerships and lessons learned. it will also focus on its sustainability without continued funding. we hope to have developed a model of service delivery that could be reproduced and sustained in other large cities with faculties of medicine. methods: non-randomized, mixed method design involving a process and impact evaluation. data collection-qualitative-a) semi structured interviews with providers & partners b)focus groups with youth quantitative a)electronic medical records for 12 months records (budget, photos, project information). results: 1) successfully built and opened a medicaudental clinic which will celebrate its 1 year anniversary in august. 2) over 140 youths have been seen, and we have had over 300 visits. conclusion: 1) the clinic will continue to operate beyond the 18 month project funding. 2) the health of high risk youth in ottawa will continue to improve due to increased access to medical services. p7-11 (a) health services -for the citizens of bangalore -past, present and future savita sathyagala, girish rao, thandavamurthy shetty, and subhash chandra bangalore city, the capital of karnataka with 6.5 million is the 6th most populous city in india; supporting 30% of the urban population of karnataka, it is considered as one of the fastest growing cities in india. known as the 'silicon valley of india', bangalore is nearly 500 years old. bangalore city corporation (bmp), is a local self government and has the statutory commitment to provide to the citizens of bangalore: good roads, sanitation, street lighting, safe drinking water apart from other social obligations, cultural development and poverty alleviation activities. providing preventive and promotive heahh services is also a specific component. the objective of this study was to review the planning process with respect to health care services in the period since india independence; the specific research questions being what has been the strategies adopted by the city planners to address to the growing needs of the population amidst the background of the different strategies adopted by the country as a whole. three broad rime ranges have been considered for analysis: the 1950s, 1970s and the 1990s. the salient results are: major area of focus has been on the maternal and child care with activities ranging from day-care to in-patient-care; though the number of institutions have grown from 5 to the current day 79, their distribution has been far from satisfactory; obtaining support from the india population projects 3 and 8 major upgradarions have been undertaken in terms of infrastructure; over the years, in addition to the dispensaries of modern system of medicine, local traditional systems have also been initiated; the city has partnered with the healthy cities campaign with mixed success; disease surveillance, addressing the problems related to the emerging non-communicable diseases including mental health and road traffic injuries are still in its infancy. isolated attempts have been made to address the risks groups of elderly care and adolescent care. what stands out remarkably amongst the cities achievements is its ability to elicit participation from ngos, cbos and neighbourhood groups. however, the harnessing of this ability into the health sector cannot be said totally successful. the moot question in all the above observed development are: has the city rationally addressed it planning needs? the progress made so far can be considered as stuttered. the analysis and its presentation would identify the key posirive elements in the growth of banglore city and spell a framework for the new public health. introduction: anaemia associated with pregnancy is a major public health problem all over the world. different studies in different parts of india shown prevalence of anaemia between 60-90%. anaemia remains a serious health problem in pregnancy despite of strong action taken by the government of india through national programmes. in the present study we identified th~ social beha~iors, responsible for low compliance of if a tablets consumption in pregnancy at community level and intervention was given with new modified behaviors on trial bases. . in vadodara urban. 60 anganwadies out of 289 were selected from the list by random sampling for tips (trials of improved practices) study. . . participants: 266 pregnant women (132, intervention group+ 134, control. group) registered m the above 60 anganwadies. study was conducted in to three phases: phase: 1. formative research and baseline survey (frbs). data was collected from all 266 pregnant women to identify behaviors that are responsible for low compliance of ifa tablets. both qualitative and quantitative data were collected. haemoglobin was estimated of all pregnant women by haemo-cue. phase: 2. phase of tips. behaviors were identified both social & clinical for low compliance of ifa tablets consumption in pregnancy from frbs and against those, modified behaviors were proposed to pregnant women in the intervention group on trial bases by health education. trial period of 6 weeks was given for trial of new behaviors to pregnant women in the interven· tion group. phase: 3. in this phase, feedbacks on behaviors tried or not tried were taken from pregnant women in intervention group. haemoglobin estimation was carried out again in all 266 pregnant women. at the end of the study, messages were formulated on the bases of feedbacks from the pregnant women. results: all pregnant women in the intervention group had given positive feedback on new modified behaviors after intervention. mean haemoglobin concentration was higher in intervention group (10.04±0.11 gm%) than control group (9.60±0.14 gm%). ifa tablets compliance was improved in intervention group (95.6%) than control group (78.6%). conclusion: all pregnant women got benefits after trial of new modified behaviors in the intervention group. messages were formulated from the new modified behaviors, which can be used for longterm strategies for anaemia control in the community. introduction: in order to develop a comprehensive mch handbook for pregnant women and to assess its effect among them, a pilot study was carried out at the maternal and child health training institute (mchti), in dhaka, bangladesh. methods: from mchti a sample of 600 pregnant women was selected and all subjects were women who were attending the first visit of their current pregnancy by using a random sampling method. of the 600 subjects, 240 women were given the mch handbook as case and 360 women were not given the handbook as control. data on pre and post intervention of the handbook from the 240 cases and 360 controls were taken from data recording forms between the 1st of november 2002 and 31st of october, 2003 and data was analysed by using a multilevel analysis approach. this was a hospital-based action (case-control) research, and was applied in order to measure the outcome of pre and post intervention following the introduction of the handbook. data was used to assess the effects of utilisation of the handbook on women's knowledge, practice and utilisation of mch services. results: this study showed that the change of knowledge about antenatal care visits was 77.1% among case mothers. knowledge of danger signs improved 49.2 %, breast feeding results 31.5%, vaccination 32.0% and family planning results improved 60.3% among case. results showed some positive changes in women's attitudes among case mothers and study showed the change of practice in antenatal care visits was .u.5% in the case. other notable changes were: change of practice in case mother's tetanus toxoid (ti), 55.2%; and family planning 41.2%. in addition, handbook assessment study indicated that most women brought the handbook on subsequent visits (83.3%), the handbook was highly utilised (i.e. it was read by 84.2%, filled-in by 76.1 %, and was used as a health education tool by 80.4%). most women kept the handbook (99.5%) and found it highly useful (78.0%) with a high client satisfaction rate of 88.0%. conclusion: pregnant women in the case group had higher knowledge, better practices, and higher utilisation of mch services than mothers in the control groups who used alternative health cards. if the handbook is developed with a focus on utilising a problem-oriented approach and involving the recomendations .of end~users, it is anticipated that the mch handbook will contribute significantly to ensuring the quahry of hfe of women and their children in bangladesh. after several meetmgs to identify the needs of the community, a faso clinic was opened at ncfs. health care professionals from smh joined with developmental and social service workers from ncfs to implement the faso diagnostic process and to provide culturally appropriate after-care. the clinic is unique in that its focus is the high risk urban aboriginal population of toronto. it accepts referrals of not only children and youth, but also of adults. lessons learned: response to the faso clinic at native child and family services has been overwhelming. aboriginal children with f asd are receiving timely diagnosis and interventions. aboriginal youth and adults who have been struggling with poveny, substance abuse, and homelessness are more willing to enter the ncfs centre for diagnosis and treatment. aboriginal infants prenatally exposed to alcohol born at st. michael's hospital or referred by other centres have access to the developmental programs located in both of the partnering agencies. the presentation will describe the clinic's development, and will detail the outcomes described, including interventions unique to the aboriginal culture. p7-15 (c) seeds, soil, and stories: an exploration of community gardening in southeast toronto carolin taran, sarah wakefield, jennifer reynolds, and fiona yeudall introduction: community gardens are increasingly seen as a mechanism for improving nutrition and increasing food security in urban neighbourhoods, but the evidence available to support these claims is limited. in order to begin to address this gap in a way that is respectful of community knowledge and needs, the urban gardening research opportunities workgroup (ugrow) project explored the benefits and potential risks of community gardening in southeast toronto. the project used a community-based research (cbr) model to assess community gardens as a means of improving local health. the research process included interviews, focus groups, and participant observation (documented in field notes). we also directly engaged the community in the research process, through co-learning activities and community events which allowed participants to express their views and comment on emerging results. most of the research was conducted by a community-based research associate, herself a community gardener. key results were derived from these various sources through line-by-line coding of interview transcripts and field note review, an interactive and iterative process which involved both academic and community partners. results: these various data sources all suggest that enhanced health and access to fresh produce are important components of the gardening experience. they also highlight the central importance of empowering and community-building aspects of gardening to gardeners. community gardens were thought to play a role in developing friendships and social support, sharing food and other resources, appreciating cultural diversity, learning together, enhancing local place attachment and stewardship, and mobilizing to solve local problems (both inside and outside the garden). potential challenges to community gardens as a mechanism for communiry development include bureaucratic resistance to gardens, insecure land tenure and access, concerns about soil contamination, and a lack of awareness and under· standing by community members and decision-makers of all kinds. conclusion: the results highlight many health and broader social benefits experienced by commu· nity gardeners. they also point to the need for greater support for community gardening programs, par· ticularly ongoing the ongoing provision of resources and education programs to support gardens in their many roles. this research project is supported by the wellesley central health corporation and the centre for urban health initiatives, a cihr funded centre for research development hased at the univer· sity of toronto. p7-16 (c) developing resiliency in children living in disadvantaged neighbourhoods sarah farrell, lorna weigand, and wayne hammond the traditional idea of targeting risk reduction by focusing on the development of eff~ctive coping strategies and educational programs has merit in light of the research reportmg_ that_ ~10lupl.e forms of problem behaviour consistently appear to be predicted by increasing exposure to 1den_uf1able risk factors. as a result, many of the disadvantaged child and youth studies have focused on trymg to better _unde.r· stand the multiple risk factors that increase the likelihood of the development of at nsk behaviour m ch1ldren/youth and the potential implications for prevention. this in turn has led t_o. the conclus1on that community and health programs need to focus on risk reduction by helpm~ md1v1duals develop more effective coping strategies and a better understanding of the limitations of cenam pathologies, problematic v156 poster sessions coping behaviours and risk factors potentially inheren~ in high needs co~unities. ~owever, another ai:ea of research has proposed that preventative interventions should cons1de~ .~rotecnve fa~ors alo~~ with reducing risk factors. as opposed to just emphasizing problems, vulnerab1ht1es, and deficits, a res1liencybased perspective holds the belief that children, youth and their families. have strengths, reso~ce.s and the ability to cope with significant adversity in ways that are not only effective, but tend to result m mcreased ability to constructively respond to future adversity. with this in mind, a participatory research project sponsored by the united way of greater toronto was initiated to evaluate and determine the resiliency profiles of children 8 -12 years (n = 500) of recent immigrant families living in significantly disadvantaged communities in the toronto area. the presentation will provide an overview of the identified protective factors (both intrinsic and extrinsic) and resiliency profiles in an aggregated format as well as a summary of how the children and their parents interpreted and explained these strength-based results. as part of the focus groups, current community programs and services were examined by the participants as to what might be best practices for supporting the development and maintaining of resiliency in children, families and communities. it was proposed that the community model of assessing resiliency and protective factors as well as proposed best strength-based practice could serve as a guide for all in the community sector who provide services and programs to those in disadvantaged neighbourhoods. p7-17 (c) naloxone by prescription in san francisco, ca and new york, ny emalie huriaux the harm reduction coalition's overdose project works to reduce the number of fatal overdoses to zero. located in new york, ny and san francisco, ca, the overdose project provides overdose education for social service providers, single-room occupancy hotel (sro) residents, and syringe exchange participants. the project also conducts an innovative naloxone prescription program, providing naloxone, an opiate antagonist traditionally administered by paramedics to temporarily reverse the effects of opiate overdose, to injection drug users (idus). we will describe how naloxone distribution became a reality in new york and san francisco, how the project works, and our results. the naloxone prescription program utilizes multiple models to reach idus, including sro-and street-based trainings, and office-based trainings at syringe exchange sites. trainings include information on overdose prevention, recognition, and response. a clinician conducts a medical intake with participants and provides them with pre-filled units of naloxone. in new york, funding was initially provided by tides foundation. new york city council provides current funding. new york department of mental health and hygiene provides program oversight. while the new york project was initiated in june 2004, over half the trainings have been since march 2005. in san francisco, california endowment, tides foundation, and san francisco department of public health (sfdph) provide funding. in addition, sfdph purchases naloxone and provides clinicians who conduct medical intakes with participants. trainings have been conducted since november 2003. to date, nearly 1000 individuals have been trained and provided with naloxone. approximately 130 of them have returned for refills and reported that they used naloxone to reverse an opiate-related overdose. limited episodes of adverse effects have been reported, including vomiting, seizure, and "loss of friendship." in new york, 400 individuals have been trained and provided with naloxone. over 30 overdose reversals have been reported. over half of the participants in new york have been trained in the south bronx, the area of new york with the highest rate of overdose fatalities. in san francisco, 570 individuals have been trained and provided with naloxone. over 96 overdose reversals have been reported. the majority of the participants in san francisco have been trained in the tenderloin, 6th street corridor, and mission, areas with the highest rates of overdose fatalities. the experience of the overdose project in both cities indicates that providing idus low-threshold access to naloxone and overdose information is a cost-effective, efficient, and safe intervention to prevent accidental death in this population. p7-18 (c) successful strategies to regulate nuisance liquor stores using community mobilization, law enforcement, city council, merchants and researchers tahra goraya presenta~ion _will discuss ~uccessful environmental and public policy strategies employed in one southen:1 cahf?rmna commumty to remedy problems associated with nuisance liquor stores. participants ~111 be given tools to understand the importance of utilizing various substance abuse prevention str~tegi~ to change local policies and the importance of involving various sectors in the community to a~_1st with and advocate for community-wide policy changes. recent policy successes from the commultles of pa~ad~na and altad~na will highlight the collaborative process by which the community mobilized resulnng m several ordmances, how local law enforcement was given more authority to monitor poster sessions v157 nonconforming liquor stores, how collaborative efforts with liquor store owners helped to remove high alcohol content alcohol products from their establishments and how a community-based organiz,uion worked with local legislators to introduce statewide legislation regarding the regulation of nuisance liquor outlets. p7-19 (c) "dialogue on sex and life": a reliable health promotion tool among street-involved youth beth hayhoe and tracey methven introduction: street involved youth are a marginalized population that participate in extremely risky behaviours and have multiple health issues. unfortunately, because of previous abuses and negative experiences, they also have an extreme distrust of the adults who could help them. in 1999, toronto public health granted funding to a non governmental, nor for profit drop-in centre for street youth aged 16-24, to educate them about how to decrease rhe risk of acquiring hiv. since then the funding has been renewed yearly and the program has evolved as needed in order to target the maximum number of youth and provide them with vital information in a candid and enjoyable atmosphere. methods: using a retrospective analysis of the six years of data gathered from the "dialogue on sex and life" program, the researchers examined the number of youth involved, the kinds of things discussed, and the number of youth trained as peer leaders. also reviewed, was written feedback from the weekly logs, and anecdotal outcomes noted by the facilitators and other staff in the organization. results: over the five year period of this program, many of youth have participated in one hour sessions of candid discussion regarding a wide range of topics including sexual health, drug use, harm reduction, relationship issues, parenting, street culture, safety and life skills. many were new youth who had not participated in the program before and were often new to the street. some of the youth were given specific training regarding facilitation skills, sexual anatomy and physiology, birth control, sexually transmitted infections, hiv, substance use/abuse, harm reduction, relationships and discussion of their next steps/future plans following completion of the training. feedback has been overwhelmingly positive and stories of life changing decisions have been reported. conclusion: clearly, this program is a successful tool to reach street involved youth who may otherwise be wary of adults and their beliefs. based on data from the evaluation, recommendations have been made to public health to expand the funding and the training for peer leaders in order ro target between 100-200 new youth per year, increase the total numbers of youth reached and to increase the level of knowledge among the peer leaders. p7-20 (c) access to identification and services jane kali replacing identification has become increasingly more complex as rhe government identification issuing offices introduce new requirements rhar create significant barriers for homeless people to replace their id. new forms of identification have also been introduced that art' not accessible to homekss peoplt-(e.g. the permanent resident card). ar rhe same time, many service providers continue to require identifi· cation ro access supports such as income, housing, food, health care, employment and employmt·nt training programs. street health, as well as a number of other agencies and community health centres, h,1, been assisting with identification replacement for homeless peoplt· for a number of years. the rnrrt·nr challenges inherent within new replacement requirements, as well as the introduction of new forn1' of identification, have resulted in further barriers homeless people encounter when rrring to access t:ssential services. street health has been highlighting these issues to government identification issuing offices, as well as policy makers, in an effort to ensure rhar people who are homeless and marginalized have ac'ess to needed essential services. bandar is a somali word for •·a safe place." the bandar research project is the product of the regent park community health centre. the research looks ar the increasing number of somali and afri· can men in the homeless and precariously house population in the inner city core of down~own toronto. in the first phase of the pilot project, a needs assessment was conducted to 1dennfy barners and issues faced by rhe somali and other african men who are homeless and have add1cr10ns issues. th_e second phase of rhe research project was to identify long rerm resources and service delivery mechamsms that v158 poster sessions would enhance the abiity of this population to better access detox, treatment, and post treatment ser· vices. the final phase of the project was to facilitate the development of a conceptual model of seamless continual services and supports from the streets to detox to treatment to long term rehabilitation to housing. "between the pestle and mortar" -safe place. p7-22 (c) successful methods for studying transient populations while improving public health beth hayhoe, ruth ewert, eileen mcmahon, and dan jang introduction: street youth are a group that do not regularly access healthcare because of their mis· trust of adults. when they do access health care, it is usually for issues severe enough for hospitalization or for episodic care in community clinics. health promotion and illness prevention is rarely a part of their thinking. thus, standard public health measures implemented in a more stable population do not work in this group. for example, pap tests, which have dearly been shown to decrease prevalence of cer· vical cancer, are rarely done and when they are, rarely followed up. methods to meet the health care needs and increase the health of this population are frequently being sought. methods: a drop-in centre for street youth in canada has participated in several studies investigating sexual health in both men and women. we required the sponsoring agencies to pay the youth for their rime, even though the testing they were undergoing was necessary according to public health stan· dards. we surmised that this would increase both initial participation and return. results: many results requiring intervention have been detected. given the transient nature of this population, return rates have been encouraging so far. conclusion: it seems evident that even a small incentive for this population increases participation in needed health examinations and studies. it is possible that matching the initial and follow-up incentives would increase the return rate even further. the fact that the youth were recruited on site, and not from any external advertising, indicates that studies done where youth trust the staff, are more likely to be successful. the presentation will share the results of the "empowering stroke prevention project" which incor· porated self-help mutual aids strategies as a health promotion methodology. the presentation will include project's theoretical basis, methodology, outcomes and evaluation results. self-help methodology has proven successful in consumer involvement and behaviour modification in "at risk," "marginalized" settings. self-help is a process of learning with and from each other which provides participants oppor· tunities for support in dealing with a problem, issue, condition or need. self-help groups are mechanisms for the participants to investigate existing solutions and discover alternatives, empowering themselves in this process. learning dynamic in self-help groups is similar to that of cooperative learning and peertraining, has proven successful, effective and efficient (haller et al, 2000) . the mutual support provided by participation in these groups is documented as contributory factor in the improved health of those involved. cognizant of the above theoretical basis, in 2004 the self-help resource centre initiated the "empowering stroke prevention project." the project was implemented after the input from 32 health organizations, a scan of more than 300 resources and an in-depth analysis of 52 risk-factor-specific stroke prevention materials indicated the need for such a program. the project objectives were:• to develop a holistic and empowering health promotion model for stroke prevention that incorporates selfhelp and peer support strategies. • to develop educational materials that place modifiable risk factors and lifestyle information in a relevant context that validates project participants' life experiences and perspectives.• to educate members of at-risk communities about the modifiable risk factors associated with stroke, and promote healthy living. to achieve the above, a diverse group of community members were engaged as "co-editors" in the development of stroke prevention education materials which reflected and validated their life experiences. these community members received training to become lay health promoters (trained volunteer peer facilitators). in collaboration with local health organizations, these trained lay health promoters were then supported in organizing their own community-based stroke prevention activities. in addition, an educational booklet written in plain language, entitled healthy ways to prevent stroke: a guide for you, and a companion guide called healthy ways to pre· vent stroke: a facilitator's guide were produced. the presentation will include the results of a tw<>tiered evaluation of the program methodology, educational materials and the use of the materials beyond the life of the project. this poster presentation will focus on the development and structure of an innovative street outreach service that assists individuals who struggle mental illness/addictions and are experiencing homelessness. the mental health/outreach team at public health and community services (phcs) of hamilton, ontario assists individuals in reconnecting with health and social services. each worker brings to the ream his or her own skills-set, rendering it extremely effective at addressing the multidimensional and complex needs of clients. using a capacity building framework, each ream member is employed under a service contract between public health and community services and a local grassroots agency. there are public health nurses (phn), two of whom run a street health centre and one of canada's oldest and most successful needle exchange programs, mental health workers, housing specialists, a harm reduction worker, youth workers, and a united church minister, to name a few. a community advisory board, composed of consumers and professionals, advises the program quarterly. the program is featured on raising the roors 'shared learnings on homelessness' website at www.sharedlearnings.ca. through our poster presentation participants will learn how to create effective partnerships between government and grassroots agencies using a capacity building model that builds on existing programs. this study aims to assess the effects of broadcasting a series of documentary and drama videos, intended to provide information about the bc healthguide program in farsi, on the awareness about and the patterns of the service usage among farsi-speaking communities in the greater vancouver area. the major goals of the present study were twofold; ( 1) to compare two methods of communications (direct vs. indirect messages) on the attitudes and perceptions of the viewers regarding the credibility of messengers and the relevance of the information provided in the videos, and (2) to compare and contrast the impact of providing health information (i.e., the produced videos) via local tvs with the same materials when presented in group sessions (using vcr) on participants' attitudes and perceptions cowards the bc healrhguide services. results: through a telephone survey, 545 farsi-speaking adults were interviewed in november and december 2004. the preliminary findings show that 53% of the participants had seen the aired videos, from which, 51 % watched at least one of the 'drama' clips, 8% watched only 'documentary' clip, and 41% watched both types of video. in addition, 27% of the respondents claimed that they were aware about the program before watching the aired videos, while 73% said they leaned about the services only after watching the videos. from this group, 14% said they called the bchg for their own or their "hildren's health problems in the past month. 86% also indicated that they would use the services in the future whenever it would be needed. 48% considered the videos as "very good" and thought they rnuld deliver relevant messages and 21 % expressed their wish to increase the variety of subjects (produ\:e more videos) and increase the frequency of video dips. conclusion: the results of this study will assist public health specialists in bc who want to choose the best medium for disseminating information and apply communication interventions in multi\:ultural communities. introduction: many theorists and practitioners in community-based research (cbr) and knowledge transfer (kt) strongly advocate for involvement of potential users of research in the development of research projects, yet few examples of such involvement exist for urban workplace health interventions. we describe the process of developing a collaborative research program. methods: four different sets of stakeholders were identified as potential contributors to and users of the research: workplace health policy makers, employers, trade unions, and health and safety associations. representatives of these stakeholders formed an advisory committee which met quarterly. over the 13 month research development period, an additional 21 meetings were held between resc:ar~h~rs and stakeholders. in keeping with participant observation approaches, field notes of group and md1v1~ ual meetings were kept by the two co-authors. emails and telephone calls were also documented. qu~h tative approaches to textual analysis were used, with particular attention paid to collaborattve v160 poster sessions relationships established (as per cbr), indicators of stakeholders' knowledge utilization (as per kt), and transformations of the proposed research (as per cbr). results: despite initial strong differences of opinion both among stakeho~ders .an~ between stakeholders and researchers, goodwill was noted among all involved. acts of rec~proc1ty included mu.rual sharing of assessment tools, guidance on data utilization to stakeho~der orga~1zat10ns, and suggestions on workplace recruitment to researchers. stakeholders demonstrated mcreases m concep~ual. un~erstand ing of workplace health e.g. they more commonly discussed more complex,. psychosocial md1cators of organizational health. stakeholders made instrumental use of shared materials based on research e.g. adapting their consulting model to more sophisticated dat~ analysis. sta~ehol?~rs recogni_zed the strategic use of their alliance with researchers e.g., transformational leadership trainmg as a~ inducement to improve health and safety among small service franchises. stakeholders helped re-define the research questions, dramatically changed the method of recruitment from researcher cold call to stakeholderbased recruitment, and strongly influenced pilot research designs. owing a great deal to the elaborate joint development process, the four collaboratively developed pilot project submissions which were all successfully funded. conclusion: the intensive process of collaborative development of a research program among stakeholders and researchers was not a smooth process and was time consuming. nevertheless, the result of the collaborative process was a set of projects that were more responsive to stakeholder needs, more feasible for implementation, and more broadly applicable to relevant workplace health problems. introduction: environmental groups, municipal public health authorities and, increasingly, the general public are advocating for reductions in pesticide use in urban areas, primarily because of concern around potential adverse health impacts in vulnerable populations. however, limited evidence of the relative merits of different intervention strategies in different contexts exists. in a pilot research project, we sought to explore the options for evaluating pesticide reduction interventions across ontario municipalities. methods: the project team and a multi-stakeholder project advisory committee (pac), generated a list of potential key informants (kl) and an open ended interview guide. thirteen ki from municipal government, industry, health care, and environmental organizations completed face to face or telephone interviews lasting 30-40 minutes. in a parallel process, a workshop involving similar representatives and health researchers was held to discuss the role of pesticide exposure monitoring. minutes from pac meetings, field notes taken during ki interviews, and workshop proceedings were synthesized to generate potential evaluation methods and indicators. results: current evaluation activities were limited but all kls supported greater evaluation effons beginning with fuller indicator monitoring. indicators of education and outreach services were imponant for industry representatives changing applicator practices as well as most public health units and environmental organizations. lndictors based on bylaw enforcement were only applicable in the two cities with bylaws, though changing attitudes toward legal approaches were being assessed in many communities. the public health rapid risk factor surveillance system could use historical baseline data to assess changes in community behaviour through reported pesticide uses and practices, though it had limited penetration in immigrant communities not comfortable in english. pesticide sales (economic) data were only available in regional aggregates not useful for city specific change documentation. testing for watercourse or environmental contamination might be helpful, but it is sporadic and expensive. human exposure monitoring was fraught with ethical issues, floor effects from low levels of exposure, and prohibitive costs. clinical episodes of pesticide exposure reported to the regional poison centre (all ages) or the mother risk program (pregnant or breastfeeding women) are likely substantial underestimates that would be need to be supplemented with sentinel practice surveillance. focus on special clinical populations e.g., multiple chemical sensitivity would require additional data collection efforts . . conc~ons: broad support for evaluation and multiple indicators were proposed, though con-s~raints associate~ with access, coverage, sensitivity and feasibility were all raised, demonstrating the difficulty of evaluating such urban primary prevention initiatives. interventionists. an important aim of the youth monitor is to learn more about the health development of children and adolescents and the factors that can influence this development. special attention is paid to emo· tional and behavioural problems. the youth monitor identifies high-risk groups and factors that are associated with health problems. at various stages, the youth monitor chancrs the course of life of a child. the sources of informa· tion and methods of research are different for each age group. the results arc used to generate various kinds of repons: for children and young persons, parents, schools, neighbourhoods, boroughs and the municipality of rotterdam and its environs. any problems can be spotted early, at borough and neigh· bourhood level, based on the type of school or among the young persons and children themselves. together with schools, parents, youngsters and various organisations in the area, the municipal health service aims to really address these problems. on request, an overview is offered of potentially suitable interventions. the authors will present the philosophy, working method, preliminary effects and future developments of this instrument, which serves as the backbone for the rotterdam local youth policy. social workers to be leaders in response to aging urban populations: the practicum partnership program sarah sisco, alissa yarkony, and patricia volland 1"'"1tliu:tion: across the us, 77.5% of those over 65 live in urban areas. these aging urban popu· lations, including the baby boomers, have already begun encounter a range of heahh and mental hcahh conditions. to compound these effects, health and social service delivery fluciuates in cities, whit:h arc increasingly diverse both in their recipients and their systems. common to other disciplines (medicine, nursing, psychology, etc.) the social work profession faces a shortage of workers who are well-equipped to navigate the many systems, services, and requisite care that this vast population requires. in the next two decades, it is projected that nearly 70,000 social workers will be required to provide suppon to our older urban populations. social workers must be prepared to be aging-savvy leaders in their field, whether they specialize in gerontology or work across the life span. mllhotu: in 2000, a study conducted at the new york academy of medicine d<>1:umcntcd the need for improved synchroniciry in two aspects of social work education, classroom instruction and the field experience. with suppon from the john a. hanford foundation, our team created a pilot proj~"t entitled the practicum pannership program (ppp) in 11 master's level schools of social work, to improvt" aginr exposure in field and classroom content through use of the following: i) community-university partnrr· ships, 2) increased, diverse student field rotations, ll infusion of competcn1."}'·drivm coursework, 41 enhancement of field instructors' roles, and 5) concentrated student recruitment. we conductt"d a prr· and post-test survey into students' knowledge, skills. and satisfaction. icarlja: surveys of over 400 graduates and field inltnk."tors rcflected increased numlk-n of .1rrm:y· univmity panncrships, as well as in students placed in aging agencin for field placements. there wa1 11 marked increase in student commitments to an aging specialization. onr year por.t·gradu:nion rcvealrd that 93% of those surveyed were gainfully employed, with 80% employed in the field of aginic. by com· bining curricular enhancement with real-world experiences the ppp instilled a broad exposurr for llu· dents who worked with aging populations in multiple urban settings. coltdtuion: increased exposure to a range of levels of practicr, including clinical, policy/ajvocaq, and community-based can potentially improve service delivery for older adulh who live in elfin, and potentially improve national policy. the hanford foundation has now elected to 1uppon cxpantion of the ppp to 60 schools nationwide (urban and rural) to complement other domntic initiatives to cnhalk"c" holistic services for older adults across the aging spectrum. bodrgnn.ntl: we arc a team of rcscarcbcn and community panncn working tcj8c(her to develop an in"itepth understanding of the mental health needs of homeless youth ~ages 16 to 24) (using qualiutivc and quantitative methods 8' panicipatory rncarch methods). it is readily apparmt that '-neless youth cxpcricnce a range of mental health problems. for youth living on the street, menul illnew may be either a major risk factor for homelessnal or may frequently emcsge in response to coping with rhe multitudinous stressors associated with homclcslllcsi including exposure to violence, prasutt to pamaplte in v162 poster sessions survival sex and/or drug use. the most frequent psychiatric diagnoses amongst the homeless gencrally include: depression, anxiety and psychosis. . . . the ultimate ob1ective of the pr~am of rei:e~ is to ~evelop a plan for intervention to meet the mental health needs of street youth. prior t_o pl~nnmg mtervenbons, .it is necessary to undertake a comprehensive assessment ~f mental health needs m this ~lnerable populanon. thus, the immediate objective of this research study is to undertake a comprehensive assessment of men· tal health needs. . . melbotlology: a mixed methodology triangulating qualitative, participatory acnon and quantitative methods will capture the data related to mental health needs of homeless youth. a purposive sample of approximately 60-80 subjecrs. ages 16 to 24, is currently being ~ted ~participate from the commu.nity agencies covenant house, evergreen centre fo~ srrc;et youth, turning p?1?t and street ~ serv~. youth living on the street or in short -term residennal programs for a mmimum of 1 month pnor to their participation; ages 16 to 24 and able to give infonned consent will be invited to participate in the study. o..tcomes: the expected outcome of this initial survey will be an increased understanding of mental health needs of street youth that will be used to develop effective interventions. it is anticipated that results from this study will contribute to the development of mental health policy, as well as future programs that are relevant to the mental health needs of street youth. note: it is anticipated that preliminary quantitative data (25 subjects) and qualitative data will be available for the conference. the authors intend to present the identification of the research focus, the formation of our community-based team, relevance for policy, as well as preliminary results. p7-31 (a) the need for developing a firm health policy for urban informal worken: the case of despite their critical role in producing food for urban in kenya, urban farmers have largely been ignored by government planners and policymakers. their activity is at best dismissed as peripheral eveo, inappropriate retention of peasant culture in cities and at worst illegal and often some-times criminal· ized. urban agriculture is also condemned for its presumed negative health impact. a myth that contin· ues despite proof to the contrary is that malarial mosquitoes breed in maize grown in east african towns. however, potential health risks are insignificant compared with the benefits of urban food production. recent studies too rightly do point to the commercial value of food produced in the urban area while underscoring the importance of urban farming as a survival strategy among the urban poor, especially women-headed households. since the millennium declaration, health has emerged as one of the most serious casualties consequent on the poverty, social exclusion, marginalisation and lack of sustain· able development in africa. hiv/aids epidemic poses an unprecedented challenge, while malaria, tuber· culosis, communicable diseases of childhood all add to the untenable burden. malnutrition underpins much ill-health and is linked to more than 50 per cent of all childhood deaths. kenya's urban poor people ~ace ~ h~ge burde~ of preventable and treatable health problems, measured by any social and bi~ medical md1cator, which not only cause unnecessary death and suffering, but also undermine econonuc development and damage the country's social fabric. the burden is in spite of the availability of suitable tools and re:c=hnology for prevention and treatment and is largely rooted in poverty and in weak healah •rstems. this pa~ therefore challenges development planners who perceive a dichotomy instead of con· tmuum between informal and formal urban wage earners in so far as access to health services is con· cemed. it i~ this gap that calls for a need to developing and building sustainable health systems among the urban mformal ~wellers. we recommend a focus on an urban health policy that can build and strengthen the capacity of urban dwellers to access health services that is cost-effective and sustainable. such ~ health poli<=>: must strive for equity for the urban poor, displaced or marginalized; mobilise and effect1~ely use sufficient sustainable resources in order to build secure health systems and services. special anenti_on. should ~ afforded hiv/aids in view of the unprecedented challenge that this epidemic poses to africa s economic and social development and to health services on the continent. methods: a review of the literature led us to construct three simple models and a composite model of exposure to traffic. the data were collected with the help of a daily diary of travel activities using a sample of cyclists who went to or come back from work or study. to calculate the distance, the length of journey, and the number of intersections crossed by a cyclist different geographic information systems (gis) were operated. statistical analysis was used to determine the significance between a measure of exposure on the one hand, and the sociodemographic characteristics of the panicipants or their geographic location on the other hand. restlltj: our results indicate that cyclists were significantly exposed to road accidents, no matter of where they live or what are their sociodemographic characteristics. we also stress the point that the fact of having been involved in a road accident was significantly related to the helmet use, but did not reduce the propensity of the cyclists to expose themselves to the road hazards. condlllion: the efforts of the various authorities as regards road safety should not be directed towards the reduction of the exposure of the vulnerable users, but rather towards the reduction of the dangers to which they could face. keywords: cyclist, daily diary of activities, measures of exposure to traffic, island of montreal. p7-33 (a) intra urban disparities and environmental health: some salient features of nigerian residential neighbourhoods olumuyiwa akinbamijo intra urban disparities and environmental health: some salient features of nigerian residential neighbourhoods abstract urbanization panicularly in nigerian cities, ponends unprecedented crises of grave dimensions. from physical and demographic viewpoints, city growth rates are staggering coupled with gross inabilities to cope with the consequences. environmental and social ills associated with unguarded rapid urbanization characterize nigerian cities and threaten urban existence. this paper repons the findings of a recent study of the relationship between environmental health across inrraurban residential communities of akure, south west nigeria. it discuses the typical urbanization process of nigerian cities and its dynamic spatial-temporal characteristics. physical and socio-demographic attributes as well as the levels and effectiveness of urban infrastructural services are examined across the core residential districts and the elite residential layouts in the town. the incidence rate of cenain environmentally induced tropical diseases across residential neighborhoods and communes is examined. salient environmental variables that are germane to health procurement in the residential districts, incidence of diseases and diseases parasitology, diseases prevention and control were studied. field data were subjected to analysis ranging from the univariate and bivariate analysis. inferential statistics using the chi-square test were done to establish the truthfulness of the guiding hypothesis. given the above, the study affirms that there is strong independence in the studied communities, between the environment and incidence of diseases hence health of residents of the town. this assertion, tested statistically at the district levels revealed that residents of the core districts have very strong independence between the environment and incidences of diseases. the strength of this relationship however thins out towards the city peripheral districts. the study therefore concludes that since most of the city dwellers live in urban deprivation, urban health sensitive policies must be evolved. this is to cater for the urban dwellers who occupy fringe peripheral sites where the extension of facilities often times are illegally done. urban infrastructural facilities and services need be provided as a matter of public good for which there is no exclusive consumption or access even for the poorest of the urban poor. many suffer from low-self esteem, shame and guilt about their drug use. in addition, they often lack suppon or encounter opposition from their panners, family and friends in seeking treatment. these personal barriers are compounded by fragmented addiction, prenatal and social care services, inflexible intake systems and poor communication among sectors. the experience of accessing adequate care between services can be overwhelming and too demanding. the toronto centre for substance use in pregnancy (t-cup) is a unique program developed to minimize barriers by providing kone-stop" comprehensive healthcare. t-cup is a primary care based program located in the department of family medicine at st. joseph\'s health centre, a community teaching hospital in toronto. the interdisciplinary staff provides prenatal and addiction services, case management, as well as care of newborns affected by substance use. regular care plan meetings are held between t-cup, labour and delivery nurses and social workers in the y164 poster sessions maternity and child care program. t-cup also connects "'.omen with. inpatient treatment programs and community agencies such as breaking the cycle, an on-site counselmg group for pregnant substance users. · f · d d h ith method: retrospective chart review, qualitative patient ~ans action stu ~· an ea care provider surveys are used to determine outcomes. primary outcomes mclude changes m maternal su~tance use, psychosocial status and obstetrical complications (e.g. pre-rupture of membrane, pre-eclampsia, placen· ral abruption and hemorrhage). neonatal measures ~~nsisted of .bir~h pa_rame~ers, length of h~spital st.ay and complications (e.g. feral distress, meconium stammg, resuscitation, 1aund1ce, hypoglycemia, seventy of withdrawal and treatment length). chart review consisted of all t-cup patients who met clinical cri· reria for alcohol or drug dependence and received prenatal and intra-partum care at st. joseph's from october 2003 to june 2005. participants in the qualitative study included former and current t-cup patients. provider surveys were distributed on-site and to a local community hospital. raulb: preliminary evaluation has demonstrated positive results. treatment retention and satisfaction rates were high, maternal substance use was markedly reduced and neonatal outcomes have shown to be above those reported in literature. conclusion: this comprehensive, primary care model has shown to be optimal in the management of substance use in pregnancy and for improving neonatal outcomes. future research will focus on how this inexpensive program can be replicated in other health care settings. t-cup may prove to be the optimal model for providing care to pregnant substance users in canada. lntrod11ction: cigarette smoking is one of the most serious health problems in taiwan. the prevalence of smoking in 2002 is 48.1 % in males 5.9% in females aged 18 years and older. although the government of taiwan passed a tobacco hazards control act in 1997, it has not been strongly enforced in many places. therefore, community residents have often reported exposure of second hand smoke. the purpose of the study was to establish a device to build up more smoke-free environments in the city of tainan. methods: unique from traditional intervention studies, the study used a healthy city approach to help build up smoke-free environments. the major concept of the approach is to build up a healthy city platform, including organizing a steering committee, setting up policies and indicators, creating intersectoral collaboration, and increasing community participation. first, more than 80 enthusiastic researchers, experts, governmental officers, city counselors and community leaders in tainan were invited in the healthy city committee. second, smoke-free policies, indicators for smoke-free environments, and mechanisms for inter-departmen· tal inspections were set up. third, community volunteers were recruited and trained for persuading related stakeholders. lastly, both penalties and rewards were used for help build up the environments. raults: aher two-year (2003 aher two-year ( -2005 execution of the project, the results qualitatively showed that smoke-free environments in tainan were widely accepted and established, including smoke-free schools, smoke-free workpla~es, smoke-free households, smoke-free internet shops, and smoke-free restaurants. smoke~s were. effectively educated not to smoke in public places. community residents including adults and children m the smoke-free communities clearly understand the adverse effects of environmental tobacco smoke and actively participated anti-smoking activities. conclruions: healthy city platform is effective to conquer the barrier of limited anti-smoking rc:sources. nor. only can it enlar:ge community actions for anti-smoking campaigns, but also it can provide par_merships for collaboratjon. by establishing related policies and indicators the effects of smoke· free environments can be susta1·ned a d th · · · ' · n e progression can be monitored m a commuruty. these issues are used ~· oi::c it~ goals, weuha identifies issues that put people's health at risk. presently, team com~u:c: ran ee~tion !earns. (iats) that design integrative solutions ~tesj'°~ g om six to fifteen members. methods in order to establish wo-poster sessions v165 projects for weuha, the following approach was undertaken: i. a project-polling template was created and sent to all members of the alliance for their input. each member was asked to identify thdr top two population groups, and to suggest a project on which to focus over a 12-18 month period for each identified population. 2. there was a 47% response to the poll and the top three population groups were identified. data from the toronto community health profile database were utilized to contextualize the information supplied for these populations. a presentation was made to the steering committee and three population-based projects were selected, leaders identified and iats formed. three population-based projects: the population-based projects and health care issues identified are: newcomer prenatal uninsured women; this project will address the challenges faced by providers to a growing number of non-insured prenatal women seeking care. a service model where the barrier of "catchments" is removed to allow enhanced access and improved and co-ordinated service delivery will be pilot-tested. children/obesity/diab etes: using a health promotion model this team will focus on screening, intervention, and promoting healthy lifestyles (physical activity and nutrition) for families as well as for overweight and obese children. seniors health promotion and circle of discharge: this team will develop an early intervention model to assist seniors/family unit/caregivers in accessing information and receiving treatment/care in the community. the circle of discharge initiative will address ways of utilizing community supports to keep seniors in the community and minimize readmissions to acute care facilities. results/expected outcomes: coordinated and enhanced service delivery to identified populations, leading to improved access, improved quality of life, and health care for these targeted populations. introduction: basic human rights are often denied to high-risk populations and people living with hiv/aids. their rights to work and social security, health, privacy, non discrimination, liberty and freedom of movement, marriage and having a family have been compromised due to their sero-positive status and risk of being positive. the spread of hiv/aids has been accelerating due to the lack of general human rights among vulnerable groups. to formulate and implement effective responses needs dialogue and to prevent the epidemic to go underground barriers like stigma need to be overcome. objective: how to reduce the situation of stigma, discrimination and human rights violations experienced by people living with hiv/aids and those who are vulnerable to hiv/aids. methodology and findings: consultation meetings were strm.-rured around presentations, field visits, community meetings and group work to formulate recommendations on how govt and ngos/cbos should move forward based on objective. pakistan being a low prevalence country, the whole sense of compl;u:enc.:y that individuals are not subject to situations of vulnerable to hiv is the major threat to an explosion in th•· epidemic, therefore urgent measures are needed to integrate human rights issues from the very start of the response. the protection and promotion of human rights in an integral component of ;tll responses to the hiv/aids epidemic. it has been recognized that the response to hiv/aios must he multi sectoral and multi faceted, with each group contributing its particular expertise. for this to occur along with other knowlcdg<" more information is required in human rights abuses related to hiv/ aids in a particular scenario. the ~·on sultarion meetings on hiv/aids and human rights were an exemplary effort to achieve the same ohj<..:tivc. recommendations: the need for a comprehensive, integrated and a multi-sectoral appro;u.:h in addressing the issue of hiv/aids was highlighted. the need social, cultural and religious asp•·ct' to he: prominently addressed were identified. it was thought imperative measures even in low prevalence countries. education has a key role to play, there is a need for a code of ethics for media people and h<"alth care providers and violations should be closely monitored and follow up action taken. p7-38 (c) how can community-based funding programs contribute to building community capacity and how can we measure this elusive goal? mary frances maclellan-wright, brenda cantin, mary jane buchanan, and tammy simpson community capacity building is recognized by the public health agency of canada (phac) as an important strategy for improving the overall health of communities by enabling communities to addre~s priority issues such as social and economic determinants of health. in 2004/2005 phac.:, alberta/nwf region's population health fund (phf) supported 12 community-based projects to build community capacity on or across the determinants of health. specifically, this included creating accessible and sup· portive social and physical environments as well as creating tools and processes necessary for healthy policy development and implementation. the objective of this presentation is to highlight how the community capacity building tool, developed by phac ab/nwf region, can demonstrate gains in v166 poster sessions · · the course of a pror· ect and be used as a reflective tool for project planning and community capacity over . . . . i · a art of their reporting requirements, 12 pro1ect sites completed the community caparny eva uanon. s p . . th t i ii i'd d . building tool at the beginning and end of their ~ne-year prorect. e oo ~o ects va 1 an reliable data in the context of community-based health prorects. developed through a vigorous ~nd collabora11ve research process, the tool uses plain languag~ to expl~re nine key f~atures o~ commuruty cap~city with 35 't ch with a section for contextual information, 26 of which also mdude a four-pomt raong 1 ems, ea f fu d · scale. results show an increase in community capacity over the course o the nde prorects. pre and post aggregate data from the one-year projects measure~ statistic.ally si~n~ficant changes for 17 of the 26 scaled items. projects identified key areas of commumty capacity bmldmg that needed strengthemng, such as increasing participation, particularly among people with low incomes; engaging community members in identifying root causes; and linking with community groups. in completing the tool, projects examined root causes of the social and economic determinants of health, thereby exploring social justice issues related to the health of their community. results of the tool also served as a reflec· cion on the process of community capacity building; that is, how the project outcomes were achieved. projects also reported that the tool helped identify gaps and future directions, and was useful as a project planning, needs assessment and evaluation tool. community capacity building is a strategy that can be measured. the community capacity building tool provides a practical means to demonstrate gains in community capacity building. strengthening the elements of community capacity building through community-based funding can serve as building blocks for addressing other community issues. needs of marginalized crack users lorraine barnaby, victoria okazawa, barb panter, alan simpson, and bo yee thom background: the safer crack use coalition of toronto (scuc) was formed in 2000 in response to the growing concern for the health and well-being of marginalized crack users. a central concern was the alarm· ing hepatitis c rate ( 40%) amongst crack smokers and the lack of connection to prevention and health ser· vices. scuc is an innovative grassroots coalition comprised of front-line workers, crack users, researcher! and advocates. despite opposition and without funding, scuc has grown into the largest crack specific harm reduction coalition in canada and developed a nationally recognized sarer crack kit distribution program (involving 16 community-based agencies that provide outreach to users). the success of our coalition derives from our dedication to the issue and from the involvement of those directly affected by crack use. setting: scuc's primary service region is greater toronto, a diverse, large urban centre. much ofour work is done in areas where homeless people, sex trade workers and drug users tend to congregate. recently, scuc has reached out to regional and national stakeholders to provide leadership and education. mandate: our mandate is to advocate for marginalized crack users and support the devdopmentof a com.p.rehensive harm reduction model that addresses the health and social needs facing crack users; and to fac1htare the exchange of information between crack users, service providers, researchers, and policy developers across canada. owrview: the proposed workshop will provide participants with an overview of the devdopment of scuc, our current projects (including research, education, direct intervention and consultation), our challenge~ and s~ccesses and the role of community development and advocacy within the coalition. pre-senter~ will consist of community members who have personal crack use experience and front-line work· ers-, sc.uc conducted a community-based research project (toronto crack users perspectives, 2005) , in w~ich 1 s focus groups with marginalized crack users across toronto were conducted. participants iden· t1f1ed health and social issues affecti h b · · · d " red . . ng t em, arrsers to needed services, personal strategies, an oue recommendations for improved services. presenters will share the methodology, results and recommen· datmns resulting from the research project. conc/usio": research, field observations and consultations with stakeholders have shown that cradck shmoke~s are at an. increased risk for sexually transmitted infections hiv/aids hepatitis c, tb an ot er serious health issues health · ff, · ' ' · · . · issues a ectmg crack users are due to high risk behavmurs, socio· economic factors, such as homeless d. · · · · d · 1 . 1 . ness, 1scrsmmat1on, unemployment, violence incarceraoons, an soc1a 1so at1on, and a lack of comprehe · h i h · ' ns1ve ea t and social services targeting crack users. · · sinct · s, owever arge remains a gross underesurnaoon. poster sessions v167 these are hospital-based reports and many known cases go unreported. however teh case, young age at first intercourse, inconsistent condom use and multiple partnersplace adolescents at high risks for a diverse array of stls, including hiv. about 19% of female nigerian secondary school students report initiating sexual intercourse before age 13 years. 39% of nigerian female secondary school students report not using a condom the last time they had sexual intercourse. more than 60% of urban nigerian teens report inconsistent condom use. methods: 371 adolescents were studied, ages 12 to 19, from benin city in edo state. the models used were mother-daughter(119), mother -son(99), father -son (87), and father-daughter(66). the effect of parent-child sexual communicationat baseline on child\'s report of sexual behavior, 6 to 12 months later were studied. greater amounts of sexual risk communication were asociated with markedly fewer episodes of unprotected sexual intercourse, reduced number of sexual partners and fewer episodes of unprotected sexual intercourse. results: this study proved that parents can exert more influence on the sexual knowledge attitudes and practise of their adolescent children through desired practises or rolemodeling, reiterating their values and appropriate monitoring of the adolescents\' behavior. they also stand to provide information about sexuality and various sexual topics. parental-child sexual communication has been found to be particularly influential and has been associated with later onset of sexual initiation among adolescents, less sexual activity, more responsible sexual attitudes including greater condom use, self efficacy and lower self -reported incidence of stis. conclusions: parents need to be trained to relate more effectively with their children/wards about issues related to sex and sexuality. family -based programs to reduce sexual risk-taking need to be developed. there is also the need to carry out cross-ethnicaland cross-cultural studies to identify how parent-child influences on adolescent sexual risk behavior may vary in different regions or countries, especially inthis era of the hiv pandemic. introduction: public health interventions to identify and eliminate health disparities require evidence-based policy and adequate model specification, which includes individuals within a socioecological context, and requires the integration of biosociomedical information. multiple public and private data sources need to be linked to apportion variation in health disparities ro individual risk factors, the health delivery system, and the geosocial environment. multilevel mapping of health disparities furthers the development of evidence-based interventions through the growth of the public health information network (phin-cdc) by linking clinical and population health data. clinical encounter data, administrative hospital data, population socioenvironmental data, and local health policy were examined in a three-level geocoded multilevel model to establish a tracking system for health disparities. nj has a long established political tradition of "home rule" based in 566 elected municipal governments, which are responsible for the well-being of their populations. municipalities are contained within counties as defined by the us census, and health data are linked mostly at the municipality level. marika schwandt community organizers from the ontario coaliti~n again~t pove~, .along ":ith ~edical practitioners who have endorsed the campaign and have been mvolved m prescnbmg special diet needs for ow and odsp recipients, will discuss the raise the rates campaign. the organizati~n has used a special diet needs supplement as a political tool, meeting the urgent needs o.f .poor ~ople m toront~ while raising the issues of poverty as a primary determinant of health and nutrtnous diet as a preventative health mea· sure. health professionals carry the responsibility to ensure that they use all means available to them to improve the health of the individuals that they serve, and to prevent future disease and health conditions. most health practitioners know that those on social assistance are not able to afford nutritious foods or even sufficient amounts of food, but many are not aware of the extra dietary funds that are available aher consideration by a health practitioner. responsible nurse practitioners and physicians cannot, in good conscience, ignore the special needs diet supplement that is available to all recipients of welfare and disabiliry (ow and odsp). a number of toronto physicians have taken the position that all clients can justifiably benefit from vitamins, organic foods and high fiber diets as a preventative health measure. we know that income is one of the greatest predictors of poor health. the special needs diet is a health promotion intervention which will prevent numerous future health conditions, including chronic conditions such as cardiovascular disease, cancer, diabetes and osteoporosis. many communiry health centres and other providers have chosen to hold clinics to allow many patients to get signed up for the supplement at one time. initiated by the ontario coalition against poverty, these clinics have brought together commu· niry organizers, community health centers, health practitioners, and individuals, who believe that poverty is the primary determinant of poor health. we believe that rates must be increased to address the health problems of all people on social assistance, kids, elders, people with hiv/aids -everyone. even in the context of understaffing, it could be considered a priority activity that has potentially important health promotion benefits. many clients can be processed in a two hour clinic. most providers find it a very interesting, rewarding undertaking. in 2004 the ontario coalition for social justice found that a toronto family with two adults and two kids receives $14,316. this is $21,115 below the poverty line. p7-43 (c) the health of street youth compared to similar aged youth beth hayhoe and ruth ewert . lntrod~on: street youth are at an age normally associated with good health, but due to their risky ~hav1ours and th~ conditions in which they live, they experience health conditions unlike their peer~ an more stable env1r~nments. in addition, the majority of street youth have experienced significant physical, sexual ~nd em.ot1onal abuse as younger children, directly impacting many of the choices they make around their physical and emotional health. we examined how different their health really is. . , methodl: using a retrospective analysis of the 11 years of data gathered from yonge street mis· 510~ 5 • evergreen health centre, the top 10 conditions of youth were examined and compared with national tren~s for similar aged youth. based on knowledge of the risk factors present in the group, rea· sons for the difference were examined. d' ~its: street youth experience more illness than other youth their age and their illnesses can bt . irect t ·~kc~ to the. conditions in which they live. long-term impacts of abus~ contribute to such signif· ~~nt t e t 0 d~slpl air that youth may voluntarily engage in behaviours or lack of self care in the hope at t cir 1ve~ w1 perhaps come to a quicker end. concl11non: although it has ion b k h th' dy clearly shows 3 d'fi . h g ee~ no~n t at poverty negatively affects health, ~siu be used to make ; erence m t .e health of this particular marginalized population. the infonnanon can relates to th . ecommendatio.ns around public policy that affects children and youth, especially as it e1r access to appropriate health care and follow up. p7-44 (cl why do urban children · b gt . tarek hussain 10 an adesh die: how to save our children? the traditional belief that urban child alid. a recent study (dhs d fr 17 r~n are better off than rural children might be no longer v urban migrants are highata th om h c~untn~s i demonstrates that the child survival prospects of rural· er an t ose m their r j · · ·grants. in bangladesh, currently 30 million 0 ~r~ 0~1gm and lower than those of urban non-idi million. health of the urban 1 ~ p~e are hvmg m urban area and by the year 2025, it would be so the popu at1on 1s a key a eals that urban poor have the worse h 1 h . concern. recent study on the urban poor rev ea t situation than the nation as a whole. this study shows that infant poster sessions v169 mortality among the urban poor as 120 per thousand, which are above the rural and national level estimates. the mortality levels of the dhaka poor are well above those of the rest of the city's population but much of the difference in death rates is explained by the experience of children, especially infants. analyzing demographic surveillance data from a large zone of the city containing all sectors of the population, research showed that the one-fifth of the households with the least possessions exhibited u5 child mortality almost three times as high as that recorded by the rest of the population. why children die in bangladesh? because their parents are too poor to provide them with enough food, clean water and other basic needs to help them avoid infection and recover from illness. researchers believed that girls are more at risk than boys, as mothers regularly feed boys first. this reflects the different value placed on girls and boys, as well as resources which may not stretch far enough to provide for everyone. many studies show that housing conditions such as household construction materials and access to safe drinking water and hygienic toilet facilities are the most critical determinants of child survival in urban areas of developing countries. the present situation stressed on the need for renewed emphasis on maternal and child healthcare and child nutrition programs. mapping path for progress to save our children would need be done strategically. we have the policies on hand, we have the means, to change the world so that every child will survive and has the opportunity to develop himself fully as a healthy human being. we need the political will--courage and determination to make that a reality. p7-45 (c) sherbourne health centre: innovation in healthcare for the transgendered community james read introduction: sherbourne health centre (shc), a primary health care centre located in downtown toronto, was established to address health service gaps in the local community. its mission is to reduce barriers to health by working with the people of its diverse urban communities to promote wellness and provide innovative primary health services. in addition to the local communities there are three populations of focus: the lesbian, gay, bisexual, transgendered and transexual communities (lgbtt); people who are homeless or underhoused; and newcomers to canada. shc is dedicated to providing health services in an interdisciplinary manner and its health providers include nurses, a nurse practitioner, mental health counsellors, health promoters, client-resource workers, and physicians. in january 2003 shc began offering medical care. among the challenges faced was how to provide responsive, respectful services to the trans community. providers had considerable expertise in the area of counselling and community work, but little in the area of hormone therapy -a key health service for those who want to transition from one gender to another. method: in preparing to offer community-based health care to the trans community it was clear that shc was being welcomed but also being watched with a critical eye. trans people have traditionally experienced significant barriers in accessing medical care. to respond to this challenge a working group of members of the trans community and health providers was created to develop an overall approach to care and specific protocols for hormone therapy. the group met over a one year period and their work culminated in the development of medical protocols for the provision of hormone therapy to trans individuals. results: shc is currently providing health care to 281 registered clients who identify as trans individuals (march 31 2005) through primary care and mental health programs. in an audit of shc medical charts (january 2003 to september 2004) 55 female-to-male (ftm) and 82 male-to-female (mtf) clients were identified. less than half of the ftm group and just over two-thirds of the mtf group presented specifically for the provision of hormones. based on this chart audit and ongoing experience shc continues to update and refine these protocols to ensure delivery of quality care. conclusion: this program is an example of innovative community-based health delivery to a population who have traditionally faced barriers. shc services also include counselling, health promotion, outreach and education. p7-46 (c) healthy cities for canadian women: a national consultation sandra kerr, kimberly walker, and gail lush on march 4 2005, the national network on environment and women's health held a pan-canadian consultation to identify opportunities for health research, policy change, and action. this consultation also worked to facilitate information sharing and networking between canadian women working as urban planners, policy makers, researchers, and service workers on issues pertaining to the health of women living in canadian cities. methods: for this research project, participants included front-line service workers, policy workers, researchers, and advocates from coast to coast, including francophone women, women with disabilities, racialized women, and other marginalized groups. the following key areas were selected as topics for du.bnes i1 alto kading .:auk of end·sugr ieaal clileue ia singapore, accounting for more than so% of new can singapore (nkfs) to embark on a prevention program (pp) 10 empo~r d1ahc 1j1u1f dieir condition bttter, emphasizing education and disease sdf·managemen1 lkilla a. essennal camponenn of good glycaemic control. we sought 10 explore the effects of a 1pecialijed edu.:a11on pro· pun od glycacmic conuol, as indicated by, serum hba ic values budine serum hba ic values were determined before un<k-rgmng the education progr ;am, which couisted of comprehensive dietary advice, ideal weight goals, and improving lipid profiln. serum hbaic values were obtained ar 3,6,9 months later to determine impact of the program. analy11• wu done uling paired !·tests significant reduction in hba le levels from 0 ro 9 month• was observed in females, chinese race, older age group(> so yean). ohew-ibmi ~ 27.nwm2, wai11 hip ratio> l),up to primary and above secondary level education and those having om urine iclt showed that increasing hbalc levels (9) had increasing urmary protein (38.± 117; .18 ±i ih so± 136) and crearinine (s2.s ± 64 7s ± 71; ioi± 7s) levels fbg rnults showed that the management nf d1abetn m the nkfs preven· tion programme is effec;rive. results also indicated 1har hba le leve11 have a linnr trend wnh unnary protein and creatinine which are imponant determinants of renal diseate tal family-focused cinical palbway1 promoce politivc outcollln for ua inner city canu allicy ipmai jerrnjm1 care llctivirits in preparation for an infanr'' dilchargr honlr, and art m1endnl lo improve effi.:k'fl.:tn of c.are. 11lere i11 paucity of tttran:h, and inconsi1trncy of rnulta on 1ht-•m!*-1 of f1m1ly·fc"-'uw d1nm 1a: to determinr whrthrr implrmentation of family.focuted c:pt 1n 1 ntnn.tt.tl unit w"n mg an inner city 1;ommunity drcl't'aki leftarh of lf•y (i.osi and rromclll'i family uo•fkllon and rt.1j1 nest for dikhargr. md6odt: family-focuk"d cpi 1041 data wm coll«ted for all infant• horn btrwttn 29 and 36 wft"k• 1t"lal111mi atr who wrtt .1dm111ed to the ntonatal unit lmgdl of -.y 111. 9 n. 14.8 day'o p c o.osi ind pma .11 d•mr., ho.nr 137.3 t 1.3 n. 36.4 ± i. i wb, p < o.os) wett n«01fiamly f.lfrt 1n the pre.(]' poup. ~11.fxtmon icofn for famihn wrre high. and families noctd thc:y wnr mott prepued to ah thrar t..lby "'-· thett was .a cosi uving of s 1,814 (cdn) per patient d1teharpd home 1n the pmi-cp poap c.-pated 10 the p"''lfoup· cortclaion· lmplrmrnr.rion of family·foanrd c:p. in a nrona1.1i umt tc"fyidi an 1nnn an com· muniry decre.ned length of'"'" mft with a high dcgrft of family uujamon, and wrre coll~nt at least 35% percent of the kathmandu population lives in slum like conditions with poor access to basic health services. in these disadvantaged areas, a large proportion of children do not receive treatment due to inaccessibility to medical services. in these areas, diarrhea, pneumonia, and measles, are the key determinants of infant mortality. protein energy malnutrition and vitamin a deficiency persists and communicable diseases are compounded by the emergence of diseases like hiv/aids. while the health challenges for disadvantaged populations in kathmandu are substantial, the city has also experienced various forms of innovative and effective community development health programs. for example, there are community primary health centers established by the kathmandu municipality to deliver essential health services to targeted communities. these centers not only provide equal access to health services to the people through an effective management system but also educate them hy organizing health related awareness programs. this program is considered one of the most effective urban health programs. the paper/presentation this paper will review large, innovative, and effective urhan health programs that are operating in kathmandu. most of these programs are currently run by international and national ngos a) early detection of emerging diseases in urban settings through syndromic surveillance: 911 data pilot study kate bassil of community resources, and without adequate follow-up. in november 2003 shelter pr.oviders ~et with hospital social workers and ccac to strike a working group to address some of th~ issues by mcre.asing knowledge among hospital staff of issues surrounding homelessness, and to build a stro?g workmg relationship between both systems in hamilton. to date the hswg has conducted four w~lkmg to~ of downtown shelters for hospital staff and local politicians. recently the hswg launched its ·~ool.k1t for staff working with patients who are homeless', which contains community resources and gu1dehnes to help with effective discharge plans. a scpi proposal has been submitted to incre~se the capacity of the hswg to address education gaps and opportunities with both shelters and hospitals around homelessness and healthcare. the purpose of this poster presentation is to share hamilton's experience and learnings with communities who are experiencing similar issues. it will provide for intera~tion around shared experiences and a chance to network with practitioners across canada re: best practices. introduction and objectives: canadians view health as the biggest priority for the federal government, where health policies are often based on models that rely on abstract definitions of health that provide little assistance in the policy and analytical arena. the main objectives of this paper are to provide a functional definition of health, to create a didactic model for devising policies and determining forms of intervention, to aid health professionals and analysts to strategize and prioritize policy objectives via cost benefit analysis, and to prompt readers to view health in terms of capacity measures as opposed to status measures. this paper provides a different perspective on health, which can be applied to various applications of health such as strategies of aid and poverty reduction, and measuring the health of an individual/ community/country. this paper aims to discuss theoretical, conceptual, methodological, and applied implications associated with different health policies and strategies, which can be extended to urban communities. essentially, our paper touches on the following two main themes of this conference: •health status of disadvantaged populations; and •interventions to improve the health of urban communities.methodology: we initially surveyed other models on this topic, and extrapolated key aspects into our conceptual framework. we then devised a theoretical framework that parallels simple theories of physkal energy, where health is viewed in terms of personal/societal health capacities and effort components.after establishing a theoretical model, we constructed a graphical representation of our model using selfrated health status and life expectancy measures. ultimately, we formulated a new definition of health, and a rudimentary method of conducting cost benefit analysis on policy initiatives. we end the paper with an application example discussing the issues surrounding the introduction of a seniors program.results: this paper provides both a conceptual and theoretical model that outlines how one can go about conducting a cost-benefit analysis when implementing a program. it also devises a new definition and model for health barred on our concept of individual and societal capacities. by devising a definition for health that links with a conceptual and theoretical framework, strategies can be more logically constructed where the repercussions on the general population are minimized. equally important, our model also sets itself up nicely for future microsimulation modeling and analysis.implications: this research enhances one's ability to conduct community-based cost-benefit analysis, and acts as a pedagogical tool when identifying which strategies provide the best outcome. p7-06 (a) good playgrounds are hard to find: parents' perceptions of neighbourhood parks patricia tucker, martin holmes, jennifer irwin, and jason gilliland introduction: neighbourhood opportunities, including public parks and physical activity or sports fields hav~ been. iden.tified as correlates to physical activity among youth. increasingly, physical activity among children 1s bemg acknowledged as a vital component of children's lives as it is a modifiable determinant of childh~d obesity. children's use of parks is mainly under the influence of parents; therefore, the purpose of this study was to assess parents' perspectives of city parks, using london ontario as a case study.m~~: this qualitative study targeted a heterogeneous sample of parents of children using local parks w1thm london. parents with children using the parks were asked for 5 minutes of their time and if willing, a s.hort interview was conducted. the interview guide asked parents for their opinion 'of city parks, particularly the one they were currently using. a sample size of 50 parents is expected by the end of the summer.results: preliminary findings are identifying parents concern with the current jack of shade in local parks. most parents have identified this as a limitation of existing parks, and when asked what would make the parks better, parents agree that shade is vital. additionally, some parents are recognizing the v170 poster sessions focused discussions during the consultation: 1. women in _poverty 2. women with disability 3. immi· grant and racialized women 4. the built and _physica_l environment. . . . . r its· participants voiced the need for integration of the following issues withm the research and policy :::na; t) the intersectional nature of urban women's health i~sues wh~ch reflects the reality of women's complex lives 2) the multisectional aspect of urban wo_m~n s health, 1ss~es, which reflects the diversity within women's lives 3) the interse~roral _dynamics within _womens hves and urban health issues. these concepts span multiple sectors -mdudmg health, educat10n, and economics -when leveraging community, research, and policy support, and engaging all levels of government.policy jmplicatiom: jn order to work towards health equity for women, plans for gender equity must be incorporated nationally and internationally within urban development initiatives: • reintroduce "women" and "gender" as distinct sectors for research, analysis, advocacy, and action. •integrate the multisectional, intersectional, and intersecroral aspects of women's lives within the framework of research and policy development, as well as in the development of action strategies. • develop a strategic framework to house the consultation priorities for future health research and policy development (for example, advocacy, relationship building, evidence-based policy-relevant research, priority initiatives}.note: research conducted by nnewh has been made possible through a financial contribution from health canada. the views expressed herein do not necessarily represent the views of health canada.p7-47 (c) drugs, culture and disadvantaged populations leticia folgar and cecilia rado lntroducci6n: a partir de un proyecto de reducci6n de daiios en una comunidad urbana en situ· aci6n de extrema vulnerahilidad surge la reflexion sobre el lugar prioritario de los elementos sociocuhurales en el acceso a los servicios de salud de diferentes colectivos urbanos. las "formas de hacer, pensar y sentir" orientan las acciones y delimitan las posibilidades que tienen los individuos de definir que algo es o no problema, asf como tambien los mecanismos de pedido de ayuda. el analisis permanenre del campo de "las culturas cotidianas" de los llamados "usuarios de drogas" aporta a la comprension de la complejidad del tema en sus escenarios reales, y colabora en los diseiios contextualizados de politicas y propuestas socio-sanitarias de intervenci6n, tornandolas mas efectivas.mitodos: esta experiencia de investigaci6n-acci6n que utiliza el merodo emografico identifica elementos socio estructurales, patrones de consumo y profundiza en los elementos socio-simb61icos que estructuran los discursos de los usuarios, caracterizandolos y diferenciandolos en tanto constitutivos de identidades socia les que condicionan la implementaci6n del programas de reduccion de daiios.resultados: los resultados que presentaremos dan cuenta de las caracteristicas diferenciadas v relaciones particulares ~ntre los consumidores de drogas en este contexto espedfico. a partir de este e~tudio de caso se mtentara co1?1enzar a responder preguntas que entendemos significativas a la hora de pensar intcrvcnciones a la med1da de poblaciones que comparten ciertas caracteristicas socio-culturales. (cuales serian las .motivaciones para el cambio en estas comunidades?, cque elementos comunitarios nos ayudan a i:nnstnur dema~~a? • cque tenemos para aprender de las "soluciones" que ellos mismos encuenrran a los usos problemat1cos? methods: our study was conducted by a team of two researchers at three different sites. the mapping consisted of filling in a chart of observable neighbourhood features such as graffiti, litter, and boarded housing, and the presence or absence of each feature was noted for each city block. qualitative observations were also recorded throughout the process. researchers analyzed the compiled quantitative and qualitative neighbourhood data and then analyzed the process of data collection itself.results: this study reveals the need for further research into the effects of physical environments on individual health and sense of well-being, and perception of investment in neighbourhoods. the process reveals that perceptions of health and safety are not easily quantified. we make specific recommendations about the mapping methodology including the importance of considering how factors such as researcher social location may impact the experience of neighbourhoods and how similar neighbourhood characteristics are experienced differently in various spaces. further, we discuss some of the practical considerations around the mapping exercise such as recording of findings, time of day, temperature, and researcher safety.conclusion: this study revealed the importance of exploring conceptions of health and well-being beyond basic physical wellness. it suggests the importance of considering one's environment and one's own perception of health, safety, and well-being in determining health. this conclusion suggests that attention needs to be paid to the connection between the workplace and the external environment it is situated in. the individual's workday experience does not start and stop at the front door of their workplace, but rather extends into the neighbourhood and environment around them. our procedural observations and recommendations will allow other researchers interested in the effect of urban environments on health to consider using this innovative methodology. introduction: responding ro protests against poor medical attention for sexually assaulted women and deplorable conviction rates for sex offenders, in the late 1970s, the ontario government established what would become over 30 hospital-based sexual assault care and treatment centres (sactcs) across the province. these centres, staffed around the clock with specially trained heath care providers, have become the centralized locations for the simultaneous health care treatment of and forensic evidence collection from sexually assaulted women for the purpose of facilitating positive social and legal outcomes. since the introduction of these centres, very little evaluative research has been conducted to determine the impact of this intervention. the purpose of our study was to investigate it from the perspectives of sexually assaulted women who have undergone forensic medical examinations at these centres.method: women were referred to our study by sactc coordinators across ontario. we developed an interview schedule composed of both closed and open-ended questions. twenty-two women were interviewed, face-to-face. these interviews were approximately one-to-two hours in length, and were transcribed verbatim. to date, 19 have been analyzed for key themes.results: preliminary findings indicate that most women interviewed were canadian born (79'yo), and ranged in age from 17 to 46 years. a substantial proportion self-identified as a visible minority ( 37'x.). approximately half were single or never married (47%) and living with a spouse or family of origin (53%). most were either students or not employed (68%). two-thirds (68%) had completed high school and onethird (37%) was from a lower socio-economic stratum. almost two-fifths (37%) of women perceived the medical forensic examination as revictimizing citing, for example, the internal examination and having blood drawn. the other two-thirds (63%) indicated that it was an empowering experience, as it gave them a sense of control at a time when they described feeling otherwise powerless. most (68%) women stated that they had presented to a centre due to health care concerns and were very satisfied ( 84 % ) with their experiences and interactions with staff. almost all (89%) women felt supported and understood.conclusions: this research has important implications for clinical practice and for appropriately addressing the needs of sexually assaulted women. what is apparent is that continued high-quality medical attention administered in the milieu of specialized hospital-based services is essential. at the same time, we would suggest that some forensic evidence collection procedures warrant reevaluation. the study will take an experiential, approach by chroruclmg the impa~ of the transition f m the streets to stabilization in a managed alcohol program through the techruque of narrative i~:uiry. in keeping with the shift in thinking in the mental health fie!~ ~his stu~y is based on a paradigm of recovery rather than one of pathology. the "inner views of part1c1pants hves as they portray their worlds, experiences and observations" will be presented (charm~z, 1991, ~· 38~)-"i?e p~ of the study is to: identify barriers to recovery. it will explore the exj?cnence of ~n~t1zanon pnor to entry into the program; and following entry will: explore the meanmg ~nd defirutto~s of r~overy ~~d the impact of the new environment and highlight what supports were instrumental m movmg pan1apants along the recovery paradigm.p7-st (a) treating the "untreatable": the politics of public health in vancouver's inner city introdudion: this paper explores the everyday practices of therapeutic programs in the treadnent of hiv in vancouver's inner city. as anthropologists have shown elsewhere, therapeutic programs do not siinply treat physical ailments but they shape, regulate and manage social lives. in vancouver's inner city, there are few therapeutic options available for the treatment of 1-ilv. public health initiatives in the inner city have instead largely focused on prevention and harm reduction strategies such as needle exchange programs, safe injection sites, and safer-sex education. epidemiological reports suggest that less than a quarter of those living with hiv in the downtown eastside (dtes) are taking antiretroviral therapies raising critical questions regarding the therapeutic economy of antiretrovirals and rights to health care for the urban poor.methods: this paper is drawn from ethnographic fieldwork in vancouver's otes neighborhood focusing on therapeutic programs for hiv treatment among "hard-to-reach" populations. the research includes participant-observation at inner city health clinics specializing in the treatment of hiv; semi· structured interviews with hiv positive participants, health care professionals providing hiv treatment, and administraton working in the field of inner city public health; and, lastly, observation at public meetings and conferences surrounding hiv treatment.r.awlts: hiv prevention and treatment is a central concern in the lives of many residents living in the inner city -although it is just one of many health priorities afflicting the community. concerns about drug resistance, cost of antiretrovirals, and illicit drug use means that hiv therapy for most is characterized by the daily observation of their medicine ingestion at health clinics or pharmacies. daily observed treatment (dot) is increasingly being adopted as a strategy in the therapeutic management of "untreatable" populations. dot programs demand a particular type of subject -one who is "compliant" to the rules and regimes of public health. over emphasis on "risky practices," "chaotic lives," and "~dh~rence" preve~ts the public health system from meaningful engagement with the health of the marginalized who continue to suffer from multiple and serious health conditions and who continue to experience considerable disparities in health.~ the ~ffec~s of hiv in the inner city are compounded by poverty, laclc of safe and affordable houamg, vanous 1llegal underground economies increased rates of violence and outbreaks of ~~~·~ly tr~nsmitted infections, hepatitis, and tuberculosi: but this research suggests 'that public health uunauves aimed at reducing health disparities may be failing the most vulnerable and marginal of citiztl1s. margaret malone 1~ vi~lence that occurs in families and in intimate relationships is a significant urban, ~unity, and pu~hc health problem. it has major consequences and far-reaching effects for women, ~~--renho, you~ sen1on, and families. violence also has significant effects for those who provide and ukllc w receive health care violence · · i · · . all lasses, · is a soc1a act mvolvmg a senous abuse of power. it crosses : ' : ' ~ 11 s;nden, ag~ ~ti~, cultures, sexualities, abilities, and religions. societal responseshali ra y oc:used on identificatton, crisis intervention and services for families and individuajs.promoten are only "-"--:-g to add h · ' · i in intimate relationshi with"-~"'.". ress t e issues of violence against women and vjoence lenga to consider i~ m families. in thi_s p~per, i analyze issues, propose strategies, and note c~· cannot be full -...l'-~ whork towards erad1canng violence, while arguing that social justice and equity y -.1ucvcu w en thett are people wh mnhod: critical social theory, an analysis that addresses culturally and ethnically diverse communities, together with a population health promotion perspective frame this analysis. social determinants of health are used to highlight the extent of the problem of violence and the social and health care costs.the ottawa charter is integrated to focus on strategies for developing personal skills, strengthening community action, creating supportive environments, devdoping healthy public policies, and re-orientating health and social services. attention is directed to approaches for working with individuals, families, groups, communities, populations, and society.ratdts: this analysis demonstrates that a comprehensive interdisciplinary, multisectoral, and multifaceted approach within an overall health promoting perspective helps to focus on the relevant issues, aitical analysis, and strategies required for action. it also illuminates a number of interacting, intersecting, and interconnecting factors related to violence. attention, which is often focused on individuals who are blamed for the problem of violence, is redirected to the expertise of non-health professionals and to community-based solutions. the challenge for health promoters working in the area of violence in families and in intimate relationships is to work to empower ourselves and the communities with whom we work to create health-promoting urban environments. social justice, equiry, and emancipatory possibilities are positioned in relation to recommendations for future community-based participatory research, pedagogical practices for health care practitioners, and policy development in relation to violence and urban health. the mid-main community health center, located in vancouver british columbia (bc), has a diverse patient base reflecting various cultures, languages, abilities, and socio-economic statuses. due to these differences, some mid-main patients experience greater digital divide barriers in accessing computers and reputable, government produced consumer health information (chi) websites, such as the bc healthguide and canadian health network. inequitable access is problematic because patient empowerment is the basis of many government produced chi websites. an internet terminal was introduced at mid-main in the summer of 2005, as part of an action research project to attempt to bridge the digital divide and make government produced chi resources useful to a broad array of patients. multi-level interventions in co-operation with patients, with the clinic and eventually government ministries were envisioned to meet this goal. the idea of implementing multi-level interventions was adopted to counter the tendency in interactive design to implement a universal solution for the 'ideal' end-user [ 1 ), which discounts diversity. to design and execute the interventions, various action-oriented and ethnographic methods were employed before and during the implementation of the internet terminal. upon the introduction of the internet terminal, participant observation and interviews were conducted using a motion capture software program to record a digital video and audio track of patients' internet sessions. this research provided insight into the spectrum of patients' capacities to use technology to fulfil their health information needs and become empowered. at the mid-main clinic it is noteworthy that the most significant intervention to enhance the usefulness of chi websites for patients appeared to be a human rather than a technological presence. as demonstrated in other ethnographic research of community internet access, technical support and capacity building is a significant component of empowerment (2). the mid-main wired waiting room project indicates that medical practitioners, medical administrators, and human intermediaries remain integral to making chi websites useful to patients and their potential empowerment. (1) over the past 5 years the environmental yo~th alliance has been of~ering a.youth as~t. mappin~ program which trains young people in community research and evaluation. wh1~st the positive expenenc~ and relationships that have developed over this time attest to the success of this program, no evaluations has yet been undertaken to find out what works for t.he youth, what ~ould be changed, and what long term outcomes this approach offers for the youth, their local community, and urban governance. these topics will be shared and discussed to help other community disorganizing and uncials governments build better, youth-driven structures in the places they live.p7-55 (a) the world trade center health registry: a unique resource for urban health researchers deborah walker, lorna thorpe, mark farfel, erin gregg, and robert brackbill introduction: the world trade center health registry (wfchr) was developed as a public health response to document and evaluate the long-term physical and mental health effects of the 9/11 disaster on a large, diverse population. over 71,000 people completed a wfchr enrollment baseline survey, creating the largest u.s. health registry. while studies have begun to characterize 9/11 bealth impacts, questions on long-term impacts remain that require additional studies involving carefully selected populations, long-term follow-up and appropriate physical exams and laboratory tests. wtchr provides an exposed population directory valuable for such studies with features that make ita unique resource: (a) a large diverse population of residents, school children/staff, people in lower man· hattan on 9/11 including occupants of damaged/destroyed buildings, and rescue/recovery/cleanup work· ers; (b) consent by 91 % of enrollees to receive information about 9/11-related health studies; (c) represenration of many groups not well-studied by other researchers; (c) email addresses of 62% of enrollees; (d) 30% of enrollees recruited from lists with denominator estimates; and (e) available com· parison data for nyc residents. wfchr strives to maintain up-to-date contact information for all enrollees, an interested pool of potential study participants. follow-up surveys are planned.methods: to promote the wtchr as a public health resource, guidelines for external researcher.; were developed and posted on (www.wtcregistry.org) which include a short application form, a twopage proposal and documentation of irb approval. proposals are limited to medical, public health, or other scientific research. researchers can request de-identified baseline data or have dohmh send information about their studies to selected wfchr enrollees via mail or email. applications are scored by the wtchr review committee, comprised of representatives from dohmh, the agency for toxic subst~nces and disease registry, and wtchr's scientific, community and labor advisory committees. a data file users manual will be available in early fall 2005.~suits: three external applications have been approved in 2005, including one &om a non-u.s. ~esearcher, all requesting information to be sent to selected wtchr enrollees. the one completed mail· mg~~ wtchr enrollee~ (o 3,700 wfc tower evacuees) generated a positive survey response rate. three additional researchers mtend to submit applications in 2005. wfchr encourages collaborations between researchers and labor and community leaders.conclusion: studies involving wtchr enrollees will provide vital information about the long· term health consequences of 9/11. wtchr-related research can inform communities, researcher.;, policy makers, health care providers and public health officials examining and reacting to 9111 and other disasters. t .,. dp'"f'osed: thi is presentation will discuss the findings of attitudes toward the repeat male client iden· 1 ie as su1e1 a and substance us'n p · · · · i · 'd . . -1 g. articipants will learn about some identified effective strategies or service prov1 ers to assist this group of i · f men are oft · d bl men. n emergency care settings, studies show that this group 0 en viewe as pro emaric patient d i r for mental health p bl h h 5 an are more ikely to be discharged without an assessmen 200!) ea 1 1 rofr ems t. an or er, more cooperative patients (forster and wu 2002· hickey er al., · r y resu ts om this study suggest th · · ' ' l · d tel' mining how best to h 1 . d 1 at negative amtudes towards patients, difficu nes e · as well pathways l_e_ p patientsblan ~ck of conrinuity of care influence pathways to mental health care. • uc\:ome pro emat1c when p ti k · che system. m a ems present repeatedly and become "get stuc id methods: semi-structured intervie d . · (n=5), ed nurses (n=5) other ed ;s were con ucted with male ed patients (n=25), ed phys1oans ' sta (n= 7) and family physicians (n= 7). patients also completed a poster sessions v175 diagnostic interview. interviews were tape-recorded, transcribed verbatim and managed using n6. transcripts were coded using an iterative process and memos prepared capture emergent themes. ethics approval was obtained and all participants signed a detailed informed consent form.introduction: urban settings are particularly susceptible to the emergence and rapid spread of nt•w or rare diseases. the emergence of infectious diseases such as sars and increasing concerns over the next influenza pandemic has heightened interest in developing and using a surveillance systt·m which detects emerging public health problems early. syndromic surveillance systems, which use data b,1scd on symptoms rather than disease, offer substantial potential for this by providing near-real-rime data which are linked to an automated warning system. in toronto, we are piloting syndromic data from the 911 · emergency medical services (ems) database to examine how this information can be used on an ongoing basis for the early detection of syndromes including heat-related illness (hri), and influenza-like-illness (ill). this presentation will provide an outline of the planned desi_gn of this system and proposed evaluation. for one year, 911 call codes which reflect heat-related illness or influenza-like-illness will be selected and searched for daily using software with a multifactorial algorithm. calls will he stratified by call code, extracted from the 911-ems database and transferred electronically to toronto public health. the data will be analyzed for clusters and aberrations from the expected with the realtime outbreak and disease surveillance (rods) system, a computer-based public health tool for the early detection of disease outbreaks. this 911-ems surveillance system will be assessed in terms of its specificity and sensitivity through comparisons with the well-established tracking systems already in place for hr! and ill. others sources of data including paramedic ambulance call reports of signs and . this study will introduce complementary data sources t~ the ed ch1e~ complamt an~ o~~rthe-counter pharmacy sales syndromic surveillance data currently bemg evaluated m ~ther ontar~o cltles. . syndromic surveillance is a unique approach to proactive(~ dete~tmg early c.hangesm the health status of urban communities. the proposed study aims to provide evidence of differential effectiveness through investigating the use of 911-ems call data as a source of syndromic surveillance information for hr! and ili in toronto. introduction: there is strong evidence that primary care interventions, including screening, brief advi<:e, treatment referral and pharmacotherapy are effective in reducing morbidity and mortality caused by substance abuse. yet physicians are poor at intervening with substance users, in part because of lack of time, training and support. this study examines the hypothesis that shared care in addictions will result in decreased substance use and improved health status of patients, as well as increased use of primary care interventions by primary care practitioners (pcps). methods: the addiction medicine service (ams) at st. joseph's health centre's family medicine department is in the process of being transformed from its current structure as a traditional consult service into a shared care model called addiction shared care (asc). the program will have three components: education, office systems and clinical shared care. as opposed to a traditional consult service, the patient will be booked with both a primary care liaison worker (pcl) and addictions physician. patients referred from community physicians, the emergency department and inpatient medical and psychiatric wards will be recruited for the study as well as pcps from the surrounding community. the target sample size is 100-150 physicians and a similar number of patients. after initial consult, patient will be recruited into the study with their consent. the shared-case model underlines the interaction and collaboration with the patient's main pcp. asc will provide them with telephone consults, advice, support and re-assessment for their patients, as well as educational sessions and materials such as newsletters and informational kits.results: the impact of this transition on our patient care and on pcp's satisfaction with the asc model is currently being evaluated through a grant provided by the ministry of health & long term care. a retrospective chart review will be conducted using information on the patient's substance use, er/clinic visits, and their health/mood status. pcp satisfaction with the program will be measured through surveys and focus groups. our cost-effectiveness analysis will calculate the overall cost of the program per patient..conclusion: this low-cost service holds promise to serve as an optimal model and strategy to improve outcomes and reduce health care utilization in addict patients. the inner city public health project introduction the inner city public health project (icphp) was desi.gned to explore new an~ innovative ways to reach marginalized inner city populations that par-t1c1pate m high health-nsk beha~1ors. much of this population struggles with poverty, addictions, mental illness and homelessness, creatmg barriers to accessing health services and receiving follow-up. this pro1ect was de~igned to evaluat~ .~e success of offering clinics in the community for testing and followup of communicable diseases uuhzmg an aboriginal outreach worker to build relationships with individuals and agencies. v1n(demographics~ history ~f testi~g ~nd immunization and participation in various health-risk behaviors), records of tesnng and 1mmumzat1ons, and mterviews with partner agency and project staff after one year.. results: t~e chr ~as i~strumental in building relationships with individuals and partner agencies ' .° the c~mmun_1~ re_sultmg m req~ests for on-site outreach clinics from many of the agencies. the increase m parnc1pat10n, the chr mvolvement in the community, and the positive feedback from the agen? staff de~onstrated that.the project was successfully creating partnerships and becoming increasingly integrated m the community. data collected from clients at the initial visit indicated that the project was reaching its target populations and highlighted the unique health needs of clients, the large unmet need for health services and the barriers that exist to accessing those services. ~usion: the outreach clinics were successful at providing services to target populations of high health-nsk groups and had great support from the community agencies. the role of the chr was critical to the success of the project and proved the value of this category of health care worker in an urban aboriginal population. the unmet health needs of this disadvantaged population support the need for more dedicated resources with an emphasis on reducing access barriers. building a caring community old strathcona's whyte avenue, a district in edmonton, brought concern about increases in the population of panhandlers, street people and homeless persons to the attention of all levels of government. the issue was not only the problems of homelessness and related issues, but feelings of insecurity and disempowerment by the neighbourhood residents and businesses. their concerns were acknowledged, and civic support was offered, but it was up to the community itself to solve the problem. within a year of those meetings, an adult outreach worker program was created. the outreach worker, meets people in their own environments, including river valley camps. she provides wrap-around services rooted in harm reduction and health promotion principles. her relationship-based practice establishes the trust for helping clients with appropriate housing, physical and/or mental health issues, who have little or no income and family support to transition from homelessness. the program is an excellent example of collaboration that has been established with the businesses, community residents, community associations, churches, municiple services, and inner-city agencies such as boyle street community services. statistics are tracked using the canadian outcomes research institute homes database, and feedback from participants, including people who are street involved. this includes an annual general meeting for community and people who are homeless. the program's holistic approach to serving the homeless population has been integral, both in creating community awareness and equipping residents and businesses to effectively interact with people who are homeless. through this community development work, the outreach worker engages old strathcona in meeting the financial and material needs of the marginalized community. the success of this program has been surprising -the fact is that homeless people's lives are being changed; one person at a time and the community has been changed in how they view and treat those without homes. over two years, the program has successfully connected with approximately seventy-five individuals who call old strathcona home, but are homeless. thirty-six individuals are now in homes, while numerous others have been assisted in obtaining a healthier and safer lifestyles by becoming connected with other social/health agencies. the program highlights the roots of homelessness, barriers to change and requirements for success. it has been a thriving program and a model that works by showing how a caring community has rallied together to achieve prosperous outcomes. the spn has created models of tb service delivery to be used m part~ers~1p with phannaceunca compa-. · · -. t' ns cooperatives and health maintenance orgamzanons (hmos). for example, the mes, c1v1c orgamza 10 , . · b tb d' · spn has established a system with pharmaceutical companies that help patients to uy me 1cmes at a special discounted rate. this scheme also allows patients to get a free one-_month's worth of~ dru_g supply if they purchase the first 5 months of their regimen. the sy_s~e~s were ~es1gned to be cm~pattble with existing policies for recording and documentation of the ph1hppme national tuberculosis program (ntp). aside from that, stakeholders were also encouraged to be dots-enabled through the use of m~nual~ and on-line training courses. the spn initiative offers an alternative in easing the burden of tb sc:rv1ce delivery from rhe public sector through the harnessing of existing private-sector (dsos). the learnmgs from the spn experience would benefit groups from other locales that _work no~ only on ~ but other health concerns as well. the spn experience showcases how well-coordinated private sector involvements help promote social justice in health delivery in urban communities.p7-63 (c) young people in control; doing it safe. the safe sex comedy juan walter and pepijn v. empelen introduction: high prevalence of chlamydia and gonorrhoea have been reported among migrants youth in amsterdam, originating from the dutch antilles, suriname and sub-sahara africa. in addition, these groups also have high rates of teenage-pregnancy (stuart, 2002) and abortions (rademakers 1995), indicating unsafe sexual behaviour of these young people. young people (aged 12 -30) from the so· called urban scene (young trendsetters in r&b/hip hop music and lifestyle) in amsterdam have been approached by the municipal health service (mhs) to collaborate on a safe sex project. their input was to use comedy as vehicle to get the message a cross. for the mhs this collaboration was a valuable opportunity to reach a hard-to-reach group.mdhods: first we conducted a need assessment by means of a online survey to assess basic knowledge and to similtaneously examine issues of interest concerning sex, sexuality, safer sex and the opposite sex. second, a small literature study was conducted about elements and essential conditions for succesful entertainment & education (e&e) (bouman 1999), with as most important condition to ensure that the message is realistic (buckingham & bragg, 2003) . third a program plan was developed aiming at enhancing the stl/hiv and sexuality knowledge of the young people and addressing communication and educational skills, by means of drama. subsequently a safe sex comedy show was developed, with as main topics: being in love, sexuality, empowerment, stigma, sti, hivand safer sex. the messages where carried by a mix of video presentation, stand up comedy, spoken word, rap and dance.results: there have been two safe sex comedy shows. the attendance was good; the group was divers' with an age range between 14 and 50 year, with the majority being younger than 25 year. more women than men attended the show. the story lines were considered realistic and most of the audients recognised the situations displayed. eighty percent of the audients found the show entertaining and 60% found it edm:arional. from this 60%, one third considers the information as new. almost all respondents pointed our that they would promote this show to their friends.con.clusion: the s.h<_>w reached the hard-to-reach group of young people out of the urban scene and was cons1d_ered entert~mmg, educational and realistic. in addition, the program was able in addressing important issues, and impacted on the percieved personal risk of acquiring an sti when not using condoms, as well as on basic knowledge about stl's. introduction: modernity has contributed mightily to the marginality of adults who live with mental illnesses and the subsequent denial of opportunities to them. limited access to social, vocational, educational, and residential opportunities exacerbates their disenfranchisement, strengthening the stigma that has been associated with mental illness in western society, and resulting in the denial of their basic human rights and their exclusion from active participation in civil society. the clubhouse approach tn recovery has led to the reduction of both marginality and stigma in every locale in which it has been implemented judiciously. its elucidation via the prism of social justice principles will lead to a deeper appreciation of its efficacy and relevance to an array of settings. methods: a review of the literature on social justice and mental health was conducted to determine core principles and relationships between the concepts. in particular, fondacaro and weinberg's (2002) conceptualization of social justice in community psychology suggests the desirability of the clubhouse approach in community mental health practice. a review of clubhouse philosophy and practice has led to the inescapable conclusion that there is a strong connection between clubhouse philosophy-which represents a unique approach co recovery--and social justice principles. placing this highly effective model of community mental health practice within the context of these principles is long overdue. via textual analysis, we will glean the principles of social justice inherent in the rich trove of clubhouse literature, particularly the international standards of clubhouse development.results: fondacarao and weinberg highlight three primary social justice themes within their community psychology framework: prevention and health promotion; empowerment, and a critical pnsp<"<·tive. utilizing the prescriptive principles that inform every detail of clubhouse development and th<" movement toward recovery for individuals at a fully-realized clubhouse, this presentation asserts that both clubhouse philosophy and practice embody these social justice themes, promote human rights, and empower clubhouse members, individuals who live with mental illnesses, to achieve a level of wdl-heing and productivity previously unimagined.conclusion: a social justice framework is critical to and enhances an understanding of the clubhouse model. this model creates inclusive communities that lead to opportunities for full partic1pil!ion 111 civil society of a previously marginalized group. the implication is that clubhouses that an· based on the international standards for clubhouse programs offer an effective intervention strategy to guarantee the human rights of a sizable, worthy, and earnest group of citizens. to a drastic increase in school enrollment from 5.9 million in 2002 to 7.5 million in 200.s. however, while gross enrollment rates increased to 104°/., in the whole country after the introduction of fpe, it remained conspicuously low at 62% in the capital city, nairobi. nairobi city's enrollment rate is lower .than thatof all regions in the country except the nomadic north-eastern province. !h.e.d1sadvantage of children bas_ed in the capital city was also noted in uganda after the introduction of fpe m the late 1990s_-many_ education experts in kenya attribute the city's poor performance to the high propornon of children hvmg m slums, which are grossly underserved as far as social services are concerned. this paper ~xammes the impact of fpe and explores reasons for poor enrollment in informal settlements m na1rob1 city. methods: the study utilizes quantitative and qualitative schooling data from the longitudinal health and demographic study being implemented by the african population and health research center in two informal settlements in nairobi. descriptive statistics are used to depict trends in enrollment rates for children aged 5-19 years in slum settlements for the period 2000-2005. results: the results show that school enrollment has surprisingly steadily declined for children aged 15-19 while it increased marginally for those aged 6-14. the number of new enrollments (among those aged 5 years) did not change much between 2001 and 2004 while it declined consistently among those aged 6-9 since 2002. these results show that the underlying reasons for poor school attendance in poverty-stricken populations go far beyond the lack of school fees. indeed, the results show that lack of finances (for uniform, transportation, and scholastic materials) has continued to be a key barrier to schooling for many children in slums. furthermore, slum children have not benefited from fpe because they mostly attend informal schools since they do not have access to government schools where the policy is being implemented.conclusion: the results show the need for equity considerations in the design and implementation of the fpe program in kenya. without paying particular attention to the schooling needs of the urban poor children, the millennium development goal aimed at achieving universal primary education will remain but a pipe dream for the rapidly increasing number of children living in poor urban neighborhoods.ps-04 (c) programing for hiv/aids in the urban workplace: issues and insights joseph kamoga hiv/aids has had a major effect on the workforce. according to !lo 35million persons who are engaged in some form of production are affectefd by hiv/aids. the working class mises out on programs that take place in communities, yet in a number of jobs, there are high risks to hiv infection. working persons sopend much of their active life time in workplaces and that is where they start getting involved in risky behaviour putting entire families at risk. and when they are infected with hiv, working people face high levels of seclusion, stigmatisation and some miss out on benefits especially in countries where there are no strong workplace programs. adressing hiv/aids in the workplace is key for sucessfull responses. this paper presents a case for workplace programing; the needs, issues and recommendations especially for urban places in developing countries where the private sector workers face major challenges.