key: cord-028517-85f1yfk5 authors: radu, iulian; tu, ethan; schneider, bertrand title: relationships between body postures and collaborative learning states in an augmented reality study date: 2020-06-10 journal: artificial intelligence in education doi: 10.1007/978-3-030-52240-7_47 sha: doc_id: 28517 cord_uid: 85f1yfk5 in this paper we explore how kinect body posture sensors can be used to detect group collaboration and learning, in the context of dyad pairs using augmented reality system. we leverage data collected during a study (n = 60 dyads) where participant pairs learned about electromagnetism. using unsupervised machine learning methods on kinect body posture sensor data, we contribute a set of dyad states associated with collaboration quality, attitudes toward physics and learning gains. body postures and gestures are nonverbal communication channels, which have been shown to reveal valuable information about learners' internal states, such as their attitudes towards a learning activity [1] , misconceptions [2] , comfort with collaborators [3, 4] . additionally, when students collaborate with other students or teachers, the amount of synchronization between their gestures and postures has been linked to collaborative learning dimensions, such as affect [5] , learning gains [1] and quality of collaboration [6, 7] . in studies involving teachers and students, body synchrony has been linked to increased learning gains [5, 10] . however, for some situations body synchrony is negatively correlated with learning. abney et al. [11] observed dyad movement using computer vision algorithms, and found that synchrony was negatively correlated with learning. another study [12] , which studied kinect dyad movements, found that body synchronization had no overall effect on any collaborative or learning measures, but found that learning gains were correlated with cycles of "cognition and action", where dyads alternated between reflecting in the activity and interacting with the system. these conflicting results indicate that further research is needed to understand the links between posture and collaborative learning. to perform such research, the traditional method is qualitative coding of video data, which requires large time investment from manual coding. over the last decade, researchers have been investigating how automated methods can be used to detect body postures and their links to student attitudes and learning [8] . in this paper we expand this research by contributing new methods for analyzing body posture data from kinect sensors, and new understanding of the relationships between posture synchronization and collaborative learning. the goal of this paper is to determine if static postures of paired participants can be used as indicators of group learning, attitudes and collaboration. we perform this investigation in the context of an augmented reality (ar) experience. decreasing costs and advanced body tracking technology make ar popular for educational use [15] , and it is valuable to understand user behaviors under this context. we use data from a previous study (<anonymized>) where 60 dyads interacted with a homemade speaker system, a common activity in learning physics. dynamic visual representations of the electromagnetic concepts of the speaker are visualized through the ar headset (fig. 1 ). we measured several dependent measures of collaboration, attitudes and learning gains. for this analysis, all variables were measured at the group level. collaboration was measured using a validated rating scheme described by meier, spada and rummel [20] , measuring collaborative processes on subdimensions such as coordination (i.e. whether participants divided tasks and managed time), information processing (i.e. whether participants shared sharing information and reached consensus), etc. attitudes towards the user experience were measured using the survey instrument in [21] measuring perception of aesthetics, endurability, focus, novelty, involvement and usability. learning was calculated as relative learning gains (rlg), which measure the amount of knowledge gained between pre and post tests of electromagnetism knowledge. relative learning gains were calculated on the overall test score, as well as on specific subdimensions such as the ability to answer transfer questions. these dependent measures were correlated with dyad participant postures, calculated based on data collected from a microsoft kinect sensor, and from the microsoft hololens headsets worn by participants. through these sensors we collected joint coordinates and gaze data from both participants, and calculated dyad posture metrics such as closeness between participants (which may signal how comfortable participants feel with each other), similarity between spine angles (which may indicate that participants mirror each other's posture), orientation towards peers (which may indicate focus on discussion), forward lean (possibly indicating engagement with the task). participants were recruited from the study pool of a laboratory at a university in the northeastern united states. participation required subjects to not know each other, have no significant prior physics knowledge, be born on/after 1976, speak english fluently, have at least a bachelor's degree, and wear no bifocal glasses. all participants first individually completed a pre-test, then a 30-min paired activity of answering worksheet questions while interacting with the apparatus, followed by individual post-test. only data from the paired activity was used for analysis. after data cleaning, the resulting dataset contains 50 dyad sessions: 25 sessions with the ar visualizations and 25 sessions without. prior to calculating kinect metrics, the kinect data was preprocessed to remove noise and disambiguate between the seated participants and researcher. we explored k-means posture clustering using the "elbow method", exploring combinations of clustering variables and number of clusters k = 2, 3, 4, 5. the optimal configuration involved k = 4 clusters and variables of spine synchrony, mean distance between participants, and discussion orientation (fig. 2 left) . figure 2 (right lists the significant correlations found between the time in each cluster and the measures, and fig. 3 shows the video frames at the datapoints that most closely represents each cluster. cluster 0, what we labeled as "turn takers", are characterized by low spine similarity and positively correlated with coordination and overall collaboration. figure 3 (top left) shows one participant is leaning forward interacting with the setup while the other is watching. this configuration indicates that low spine synchrony could be indicative of a collaboration style where participants take turns interacting with the setup. this is supported by research in [12] where cycles of leaning forward and backward indicated cycles of reflection and action were found across successful dyads. cluster 1 "open to collaboration", is characterized by low distance between participants and participants facing parallel to each other, and is correlated with overall positive attitudes and learning. figure 3 (top right) shows both participants are sitting close to each other and are engaged in the task in front of them, and left participant in a thinking pose. this configuration appears to show participants highly focused on the task and which would explain a positive correlation with overall attitude and learning. cluster 2 "closed to collaboration", is characterized by high distance between participants and with participants facing each other, and is negatively correlated with overall positive attitudes toward the experience. this clustering configuration seems to be indicative of a more negative experience where participants spend some time facing each other yet remain more distant. the figure above shows a dominant interaction where one participant dominates the activity while the other is sitting back. cluster 3 "synchronized lean", is characterized by high average distance and high spine synchronization, and is negatively correlated with overall coordination. in contrast to cluster 0, this may indicate the dyad does not spend much time taking turns and that both participants were leaning forward and backward at the same time. in this paper we used unsupervised machine learning methods on body posture sensor data. we detected different posture clusters associated with collaboration and learning, finding these metrics were correlated to dyad posture variables such as spine similarity, distance between peers, and synchronized orientation of participants. we found that when participant spines were not synchronized, the dyad pair tended to show higher levels of coordination. this may indicate that dyads who are good at coordinating tend to take turns, as participants move individually before sharing what they gained from their individual explorations. this result aligns with results from [12] , where iterating between active and passive states was significantly correlated with learning gains (interpreted as cycling through moments of reflection and action). alternatively, this may indicate participants are individually active at the same time, leading to high levels of individual movement. additionally, dyads who were physically closer to each other throughout the activity had better overall attitudes toward the collaborative task. also, participants who spent more time focused on the activity rather than each other had more positive attitudes. one interpretation is that when people are engaged in the activity, they will be highly focused on the task and enjoying each others' interactions; conversely, participants who are bored will turn to each other to talk more. dyads also communicated better when leaning forward. people who were leaning forward are likely to be more engaged in the activity, and people who are leaning backward are likely to be more disengaged; this is likely to be reflected in their communication. the methodology and findings presented in this paper have larger implications for the learning sciences community, as they can serve to indicate markers of successful and unsuccessful collaborations, possibly applicable to other contexts where dyad pairs are learning through interaction with physical objects, and useful to designing systems that monitor student learning through body posture observations. we acknowledge the potential statistical errors introduced by performing large numbers of correlations due to the exploratory nature of our research. automatic detection of nonverbal behavior predicts learning in dyadic interactions hooks and shifts: a dialectical study of mediated discovery disequilibrium in the mind, disharmony in the body presentation skills estimation based on video and kinect data analysis group rapport: posture sharing as a nonverbal indicator automatically detected nonverbal behavior predicts creativity in collaborating dyads interpersonal synchrony: a survey of evaluation methods across disciplines synchrony and cooperation nonverbal synchrony in psychotherapy: coordinated body movement reflects relationship quality and outcome moving memories: behavioral synchrony and memory for self and others movement dynamics reflect a functional role for weak coupling and role structure in dyadic problem solving unraveling students' interaction around a tangible interface using multimodal learning analytics joint attention: its origins and role in development leveraging mobile eye-trackers to capture joint visual attention in co-located collaborative learning groups augmented reality in education: a meta-review and cross-media analysis experimenting with electromagnetism using augmented reality: impact on flow student experience and educational effectiveness creating interactive physics education books with augmented reality investigating augmented reality support for novice users in circuit prototyping looking inside the wires: understanding museum visitor learning with an augmented circuit exhibit a rating scheme for assessing the quality of computersupported collaboration processes developing and evaluating a reliable measure of user engagement key: cord-335007-27a3h2lo authors: dreyer, nancy a.; reynolds, matthew; defilippo mack, christina; brinkley, emma; petruski-ivleva, natalia; hawaldar, kalyani; toovey, stephen; morris, jonathan title: self-reported symptoms from exposure to covid-19 provide support to clinical diagnosis, triage and prognosis: an exploratory analysis date: 2020-11-03 journal: travel med infect dis doi: 10.1016/j.tmaid.2020.101909 sha: doc_id: 335007 cord_uid: 27a3h2lo background: symptomatic covid-19 is prevalent in the community. we identify factors indicating covid-19 positivity in non-hospitalized patients and prognosticators of moderate-to-severe disease. methods: appeals conducted in april-june 2020 in social media, collaborating medical societies and patient advocacy groups recruited 20,476 participants ≥18 years who believed they had covid-19 exposure. volunteers consented on-line and reported height, weight, concomitant illnesses, medication and supplement use, residential, occupational or community covid-19 exposure, symptoms and symptom severity on a 4-point scale. of the 12,117 curated analytic population 2,279 reported a covid-19 viral test result: 865 positive (covid+) and 1,414 negative (covid-). results: the triad of anosmia, ageusia and fever best distinguished covid+ from covid-participants (or 6.07, 95% ci: 4.39 to 8.47). covid+ subjects with bmi≥30, concomitant respiratory disorders or an organ transplant had increased risk of moderate-tosevere dyspnoea. race and anti-autoimmunity medication did not affect moderate-to-severe dyspnea risk. conclusions: the triad of anosmia, ageusia and fever differentiates covid-19. elevated risks of severe symptoms outside the hospital were most evident among the obese and those with pulmonary comorbidity. race and use of medication for autoimmune disease did not predict severe disease. these findings should facilitate rapid covid-19 diagnosis and triage in settings without testing. trial registration: clinicaltrials.gov nct04368065, eu pas register eupas36240. limited information is available concerning the symptomatology of human coronavirus disease 2019 (covid-19) outside of the hospital [1, 2] . here we follow a research model developed in collaboration with the european medicines agency that validated person-generated healthdata as a reliable method for pharmacovigilance [3] , and use established best practices for patient registries that have been particularly useful in pandemic threats [4, 5, 6] . we build on these models using community-driven research to characterize symptoms indicative of a positive covid-19 viral test result and identify risk factors for development of serious symptoms of covid-19 infection outside the hospital setting. respondent-driven sampling in the us from april 2 nd to july 14 th 2020 inclusive, yielded 20,476 adults who completed registration, demographics and symptoms forms at www.helpstopcovid19.com. participants were recruited using social media, with additional awareness raising activities undertaken by medical societies and patient advocacy groups. every state in the us is represented, with most participants coming from populous states with high infection rates: california (9%), new york (9%), florida (7%) and texas (6%). participants provided information about testing and test results; noting that only viral testing was available during this sampling timeframe and most participants reported not having been tested (70%). reported were: covid-19-like symptoms using a checklist [7] and ranked the reported symptoms on a 4-point severity scale from very mild to severe; comorbidities; presence of fever, use of prescription and non-prescription medication, vitamins and supplements; occupation as well as age, gender and ethnicity. survey respondents were invited to participate in longitudinal follow-up twice a week for four weeks and every two weeks for the following two months. participants were not required to answer every question. no remuneration was provided. a curated analytic data set (n=12,117) was created for adults who completed baseline screening of symptoms and demographics, and which excluded likely fabricated entries based on a combination of clinical flags (e.g., body mass index (bmi) <15 or >60, height < 4ft) and likely duplicates, determined by nearly identical respondent entries within 10 minutes of each other. no missing data were imputed. participants who tested positive (covid+) were compared to those who tested negative (covid-). odds ratios (or) and 95% confidence interval (ci) were used to estimate the likelihood that a symptom or characteristic (or constellation thereof) would be present given a positive test result. a multivariable logistic regression was used to estimate the or (95%ci) of developing moderate or severe 5dyspnea among covid+ participants. two models were applied -a reduced model that included demographic characteristics and a full model that added comorbidities and medication use. a total of 12,117 participants were included in the curated dataset (71% female; median age 43 years and 24% non-caucasian), out of which n=2,279 (19%) reported a covid-19 test result. baseline data are shown for 2,279 participants, including covid+ (n=863) and covid-(n=1,414). participants reporting a covid-19 test result had a mean age of 41 years, with 13% over 60 years of age, and nearly twice as many females as males; 20% of participants reported education level of "high school or less" (table 1) . fever, cough, fatigue and aches and pains were the most commonly reported symptoms, with more symptoms reported on average by covid+ than covid-participants (5.5 vs 3.4) ( triad. covid+ participants who reported anosmia or ageusia also had a mean of nine symptoms, in contrast to a mean of just two for those without either symptom. moderate or severe 6dyspnea was more frequently reported by covid+ (24%) than covid-(15%) participants. among covid+ participants the risk of moderate or severe 6dyspnea did not differ by age, gender, race, or ethnicity. particularly, risk was elevated among the obese (bmi>30) (or 2.30 95%ci 1.40, 3.78) and those taking medications for respiratory disorders (or 3.68 95%ci 2.04, 6.62). there was no strong evidence of elevated risk for 6dyspnea among participants with cardiovascular disease or those taking medications for diabetes, hypertension and autoimmune conditions (table 3) . this research program is unusual in its evaluation of symptomatology for covid-19 in the community setting [8] and may be particularly helpful in a number of travel medicine related settings, e.g. on board cruise ships and in other maritime settings, including naval vessels; during military deployments and in remote or resource poor settings [9, 10, 11, 12, 13] . anosmia and ageusia were the most likely symptoms indicative of a positive test results, and participants reporting either of these had more symptoms and of greater severity [8] . this is in line with previous findings and experimental evidence supporting involvement of the olfactory apparatus [14, 15] . the triad of anosmia, ageusia and fever provided a particularly powerful symptom constellation differentiating covid+ from covid-in the community. this triad may offer an expeditious way to identify probable covid-19 infections in the community, especially in the absence of reliable, widespread testing [9, 16, 17] the triad could be taken as pathognomonic during the pandemic and trigger anti-covid interventions in the absence of reliable nearpatient diagnostics. this may be particularly helpful in many travel medicine or community based settings including resource-poor, logistically challenged or remote settings, as well as in closed community settings e.g. the military, prisons, care homes, seagoing vessels. further support for a clinical diagnosis of covid-19 might also be a history of vomiting. although nonspecific, vomiting is in general not a feature of respiratory tract infections in the community [18, 19] . severe 7dyspnea is indicative of severe disease that may require hospitalization and may presage possible pulmonary fibrosis or other sequelae [20, 21, 22, 23] . while our findings are congruent with obesity being a known risk factor for severe disease, the association of significant 7dyspnea with obesity in a community setting raises concerns about referral thresholds. it may well be prudent to have a very low threshold for referral and admission of symptomatic obese patients. the same consideration could also apply to patients with underlying respiratory disorders. however, there was no evidence for a marked increase in risk among people who reported underlying cancer or cardiovascular disease, or those taking medications for autoimmune disease, diabetes, or hypertension. the absence of increased risk of severe disease in users of medication for auto-immune disorders is similar to previous findings indicating that use of disease modifying agents does not increase the risk of complications from seasonal influenza [24] . the findings of increased risk of severe disease in the presence of obesity were in line with existing evidence on covid-19 [25] and are somewhat in contrast with previous findings in seasonal influenza, which pointed to decreasing risk of influenza complications with increasing bmi [26] , supporting the distinct pathology and immunopathology of covid-19. our findings would be strengthened by complementary analyses of other clinical and treatment information for obese participants and those on medication for auto-immune disorders, including if and how they are being treated for these underlying conditions; a possible explanation may be that individuals with more severe conditions were underrepresented in our study, but this remains speculative. further validation may be derived from additional data collection and analysis from subsequent waves of infection, a process that has already been initiated. it is important to keep in mind that these data are voluntarily reported, are not a representative sample of the us population, and thus will not support inferences about distribution of symptoms in the us. recognizing that self-reported information has limitations, comparisons between respondents may nevertheless indicate true causal relationships and can serve to stimulate further research as the medical and scientific community seek to learn more j o u r n a l p r e -p r o o f about this infection. this methodology appears to be useful in capturing relevant real world data, particularly symptom severity, without requiring physical presentation for clinical assessment, and offers valuable perspective on the true burden of illness as well as signaling those at particularly high risk of severe symptoms and, in parallel, those unlikely to be at such increased risk. the findings may help guide diagnosis and triage in settings where there is not ready access to rapid and reliable diagnostic testing. approximately 10-12% of participants did not respond to one or more of these questions b n=852 (7%) of all participants, n=80 (9.2%) of covid+ and n=97 (6.9%) of covid-participants did not provide an answer in this section notes: shortness of breath and severity assessed at baseline. participants who reported shortness of breath, but did not report severity of the symptom were excluded from this analysis (n=11). a referent category includes participants who reported not having the condition of interest or not taking the medication of interest pathophysiology, transmission, diagnosis and treatment of coronarvirus disease 2019 (covid-19). a review prevalence of asymptomatic sars-cov-2 infection. a narrative review direct-to-patient research: piloting a new approach to understanding drug safety during pregnancy recognizing true h5n1 infections in humans during confirmed outbreaks registries for evaluating patient outcomes: a user's guide. conducted under contract no agency for healthcare research and quality investigating outbreaks of novel infectious disease: an international case study real-time tracking of self-reported symptoms to predict potential covid-19 covid-19: travel health and the implications for sub -saharan africa more than 30 coronavirus cases on pacific aircraft carrier, new ones discovered on another carrier in japan: officials coronavirus : plusieurs cas suspects à bord du porte-avions français charles-de-gaulle french aircraft carrier heads home early due to possible covid-19 cases dolfijn breekt reis af vanwege corona -nieuwsbericht -defensie.nl". defensie.nl olfactory and gustative disorders for the diagnosis of covid-19 sars-cov-2 infects and damages the mature and immature olfactory sensory neurons of hamsters van den bruel a. antibody tests for identification of current and past infection with sars-cov-2. cochrane database of systematic reviews oseltamivir effectiveness in seasonal influenza patients taking symptomatic therapy: retrospective analysis of rct data clinical features of covid-19 and influenza: a comparative study on nord franche-comte cluster. microbes and infection long term respiratory complications of covid-19 pulmonary fibrosis and covid-19: the potential role for antifibrotic therapy. the lancet covid-19 patients with pulmonary fibrotic tissue: clinical pharmacological rational of antifibrotic therapy pulmonary fibrosis secondary to covid-19: a call to arms? rheumatoid arthritis and the incidence of influenza and influenza-related complications: a retrospective cohort study single cell sequencing unraveling genetic basis of shared immunologic switch between severe covid19 and obesity epub ahead of print body mass index and the incidence of influenza-associated pneumonia in a uk primary care cohort. influenza and other respiratory viruses we would like to acknowledge dr. sally mcnagny for her clinical insights and alison bourke for her contributions to the data curation.funding sources: no funding was received for this work. key: cord-282526-b8tky324 authors: berger gillam, t.; cole, j.; gharbi, k.; hitchcock, m.; edwards, d.; brabbs, t.; lipscombe, j.; davidson, r.; rushworth, s. a.; steel, n. title: norwich covid-19 testing initiative: feasibility project evaluation date: 2020-09-23 journal: nan doi: 10.1101/2020.09.22.20199455 sha: doc_id: 282526 cord_uid: b8tky324 background there is a high prevalence of covid-19 in university-age students, who are returning to university campuses. there is little evidence regarding the feasibility of universal, asymptomatic testing to control outbreaks in this population. this study aimed to pilot mass covid-19 testing on a university research park, to assess the feasibility and acceptability of scaling up to all staff and students. methods this was a cross-sectional feasibility study on a university research park in the east of england. staff and students (5,625) on the research park were eligible to participate. polymerase chain reaction (pcr) testing was offered to all participants. participants were offered 4 swabs, which they self-administered over a two-week period. outcome measures included: uptake; drop-out rate; positivity rates; participant acceptability measures; laboratory processing measures. results 798/1053 (76%) of those who registered provided at least one swab and of these, 687 (86%) provided all four. 681/687 (99%) had all negative results. 6 participants had one inconclusive result. there were no positive results. 458/798 (57%) participants responded to a post-testing questionnaire. 446/458 (97.5%) of those who responded agreed that they would be interested in repeat testing in the future. conclusions repeated self-testing is feasible and acceptable to a university population. universities are considering methods of dealing with the transmission of covid-19 when students return to campus. students are likely to have a higher than average prevalence of infection (1) and in particular, a high rate of asymptomatic infection (2) . this population is also highly mobile and more likely to have a large number of social contacts (3) . it remains unclear how an outbreak might evolve on a university campus, but modelling studies suggest that students are highly interconnected, indicating significant potential for infectious disease transmission (4, 5) . colleges in the usa have already reported outbreaks among the student population, necessitating closure in some cases (6) . the uk government is exploring community-wide testing for asymptomatic covid-19 infection as a potential health protection tool, to enable outbreaks to be identified and controlled early (7) . a sage consensus statement has suggested that such a strategy might be useful in "well-defined higher risk settings", such as universities (8) . this method is largely untested within a university setting, however. this pilot study was based in the norwich research park (nrp), which includes the university of east anglia (uea) and a range of business and research institutions. the study offered four covid-19 pcr swabs to all staff and students on the site over a twoweek period, with the aim of piloting communications, logistics and laboratory processes, and assessing participant acceptability in preparation for larger-scale testing. all participants living or working on the nrp were eligible to participate and were invited to join the study via an email cascade to staff and students. ethics approval (no. 2019/20-140) was obtained from the uea research ethics committee. a secure web application was developed and hosted by the school of computer science at the uea. participants registered on the web application and were invited to verify their email accounts. all those who verified their accounts were considered to have enrolled in the study. 180 people participated in a pre-trial, in which they returned two swabs. for the main study, participants were offered four swab tests over two weeks. they collected swab kits, self-administered the swab and returned the test in pre-booked return slots. for the purposes of this report the pre-trial and main trial are considered as a single trial. swabs were processed in dedicated laboratory facilities at the earlham institute (ei) from monday to friday. copan liquid amies elution swabs (eswabs) were used for all participants. participant samples were tested for the presence of sars-cov-2 using a quantitative polymerase chain reaction (qpcr) assay. briefly, nasopharyngeal swab samples were pre-treated with a lysis buffer (cytiva) that disrupts human cells and viral particles to release nucleic acid into solution. following inactivation, rna was extracted using sera-xtracta virus/pathogen kit (cytiva) on a liquid handling platform (beckman nxp). rna extracts were amplified for detection of the target genes using a set of optimised primers and probes (2019-ncov cdc eua kit, idt), and enzymes (qpcrbio probe 1-step go no-rox, pcrbioystems) in a real-time pcr system (quantstudio5, thermofisher). the assay is qualitative with results assessed based on a threshold cycle (ct value) to determine outcome (positive, negative, insufficient) using a combination of ct value for the viral target (n1) and human internal control gene (rpp30) genes. positive and negative controls were included in every rna extraction and qpcr run for quality control. negative or inconclusive results were posted on participants' online accounts. a protocol for managing positive results was developed, including notifying participants and nhs track and trace by telephone, and advising participants to share their results with their gp. . cc-by-nc-nd 4.0 international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) preprint the copyright holder for this this version posted september 23, 2020. . https://doi.org/10.1101/2020.09.22.20199455 doi: medrxiv preprint 3 after the completion of the feasibility project, participants who had returned at least one swab were emailed a link to complete a short online participant feedback questionnaire, including questions on demographics and their experience of the project. groups were compared with chi-squared tests and free text responses were analysed by extraction of key themes. results are summarised in figures 1 and 2 and tables 1 and 2. table 1 includes all participants from the pretrial (n= 180) and main trial (n=873). figure 2 relates to the post-study participant survey (n=458). 19% of the eligible population enrolled in the study and 24% of these dropped out of the study prior to returning any samples. 86% (687/798) of participants who received at least one result returned all four swabs. 6 participants received 1 inconclusive result. all other results were negative (see figure 1 ). all participants received at least one negative swab. participants had free choice over the method of returning swabs: pedestrian access sites were favoured over vehicle access sites. the post-trial survey found that the overall acceptability rating was 4.5 stars and 97% of participants would take up repeat testing if available. self-swabbing received the lowest score for participant acceptability (71% agree or strongly agree that taking the swabs was easy to do). 81% of responders to the post-trial survey were staff and 16% were students. . cc-by-nc-nd 4.0 international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) preprint the copyright holder for this this version posted september 23, 2020. there was no significant demographic difference between those enrolled but did not participate and those who did participate. . cc-by-nc-nd 4.0 international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) preprint the copyright holder for this this version posted september 23, 2020. . https://doi.org/10.1101/2020.09.22.20199455 doi: medrxiv preprint an analysis of guidance documents provided for participants, including an instruction leaflet, standard emails and website text found an average flesch reading ease score of 60.1. this indicates that material should be comprehensible to a person aged 13-15 years. the instruction leaflet for participants undertaking swabbing had a score of 74, which indicates greater readability. the text for participants opening an online account had a score of 46.8, which indicates that the reader requires a university education to understand the text. participant acceptability was assessed in two rounds; first by encouraging email comments during the testing process and second by a formal questionnaire. key themes emerging from participant emails included eligibility and logistical questions. there were very few emails regarding the process of self-swabbing. 458 participants (57%) responded to the survey. responders were generally positive about their experience of the project, and the overall mean response score was 4.51 stars out of 5. 89% of those who responded to the survey returned all four swabs. 34% of responders were working or studying onsite, with the rest working either partly or exclusively from home. 77.5% of survey responders lived 5 miles or less from the nrp. responders were not significantly more likely than all 798 participants to have returned all 4 swabs (89% and 86% respectively, p=0.46). there were no statistically significant differences between those who provided all 4 swabs (n=409) and those who provided fewer than 4 (n=49) in demographics or any answers, including the mean response score (4.54 and 4.50 stars out of 5 respectively, p=0.83). 43 of the 49 responders who provided fewer than 4 swabs gave a reason: 21 (48%) were away during part of the study, and another 8 (19%) forgot or were unexpectedly busy with other commitments. 266 responders (59%) answered the free text questions ("is there any feedback you would like to share about any aspect of your participation in the project?" and "is there a reason why you were unable to take any selfswab samples?"). responses were generally positive and included requests for ongoing testing, feedback on results of the study and praise for organisation and response to enquiries. responders recommended clearer communication on the variability of time to receive results, as some interpreted a longer wait as being suggestive of a positive result. they also requested clearer instructions regarding packing samples. main findings of this study 827 participants took and delivered their swabs over a two-week period. the relatively low uptake can be explained by the timing of the study during the summer break, the absence of staff from campus due to working-from-home policies and a short run-up to the study. nearly a quarter of participants dropped out of the study prior to returning any samples. the reasons for this were unclear from the evaluation, however there was no significant demographic difference between those who enrolled in the study but did not participate, and those who did participate. the sex distribution of the eligible population was not available, it is therefore not possible to determine whether the sample population (55% women) was reflective of the eligible population. the ethnic distribution of the study population was broadly reflective of the population of norwich: 10.9% of participants were of asian, black, mixed or 'other' ethnicity, compared to 9.1% for norwich (9) . the study did not identify any false positives, despite this being considered a risk of universal testing (10) . an analysis of guidance documents and participant emails indicates a need for clearer information tailored to the eligible population. the participant questionnaire revealed a high level of participant engagement and acceptability. combined with the low drop-out rate (86% of participants who returned at least one swab . cc-by-nc-nd 4.0 international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) preprint the copyright holder for this this version posted september 23, 2020. . https://doi.org/10.1101/2020.09.22.20199455 doi: medrxiv preprint 6 returned all four), this suggests that participants found self-swabbing and the collection and delivery of samples generally acceptable. the laboratory processed 3046 swabs during the study. lab processes were effective, with an average processing time of just over 24 hours during the week. the reagent cost per test of £3.61 was for under 6,000 tests which were ordered quickly from outside the uk, and we would expect lower costs per test in a larger initiative. what is already known on this topic the evidence base for use of asymptomatic testing for covid-19 as an infection control measure remains limited. universal, repeat testing has been advocated however, as a means of avoiding lockdown (11) . universities across the world are now considering universal testing despite the pitfalls of this strategy, which include false positive and negative tests, the difficulty of defining an active infection and significant cost (10) . colleges in the usa have already reported outbreaks of covid-19 (12) . modelling studies have indicated that the potential for covid-19 transmission in universities is significant, particularly shortly after the beginning of term when students return to campus (4, 5) . they demonstrate that universal testing may have a significant impact on control of the virus, depending on the ability of the setting to implement other control methods (13) . there is however, no published study of a universal programme for repeat testing for covid-19 on a university campus. what this study adds this pilot study indicates that universal testing on a university campus is both feasible and acceptable to the population. a strength of this study is that it trialled the feasibility of repeat testing for covid-19 in a relatively large, asymptomatic population within a research park and university campus. participants included both staff and students and the findings can be applied both to a larger study on the same site and to other university contexts. there was a high level of patient engagement with the study. this study has demonstrated that clear, consistent communications are necessary for helping participants to understand the need for testing and the process of undertaking and returning the test. both universal testing and the current national public health strategy of testing symptomatic people via a local testing site have strengths and weaknesses. the current national strategy of symptomatic testing is adequate when there are few cases in the community, and is cheaper in the short term, but risks allowing undetected spread of covid-19 when cases start to rise in a community. the main potential problem with universal testing is that it may generate false positives, and therefore unnecessary contact tracing and isolation. it is also more expensive in the short term. there were no false positives out of 3,046 tests in this study. the main advantage of universal testing is that it can identify infectious asymptomatic cases and isolate them before they can infect others in the community. this is a major benefit on a campus university expecting large numbers of students to come together in a community where isolation and social spacing may be challenging to maintain, and where the financial and reputational costs of responding to a major outbreak would be substantial. limitations of the study include the relatively low uptake and the low prevalence of covid-19 in this population, which meant that processes for managing positive results could not be tested. as this was a selfselecting cohort of university staff and students, motivation to participate may be higher than in the general population. the findings are generalisable to university staff but may be less generalisable to new undergraduates. this study used pcr swabs but acceptability of some alternative testing methods, such as saliva testing, may be even higher. . cc-by-nc-nd 4.0 international license it is made available under a is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the author/funder, who has granted medrxiv a license to display the preprint in perpetuity. (which was not certified by peer review) preprint the copyright holder for this this version posted september 23, 2020. . https://doi.org/10.1101/2020.09.22.20199455 doi: medrxiv preprint age-dependent effects in the transmission and control of covid-19 epidemics covid-19 social study: results release 17 simulating covid-19 in a university environment the small-world network of college classes: implications for epidemic spread on a university campus colleges ask students to leave campus amid covid-19 outbreaks press release: £500 million funding for quick result covid-19 test trials. department of health and social care multidisciplinary task and finish group on mass testing: consensus statement for sage. uk government. 31 st covid-19 mass testing programmes universal weekly testing as the uk covid-19 lockdown exit strategy. the lancet covid-19 outbreak among college students after a spring break modelling testing frequencies required for early detection of a sars-cov-2 outbreak on a university campus. medrxiv : the preprint server for health sciences thanks to the volunteers who assisted with this project. thanks also to jeannette chin and members of the ei covid-19 testing initiative (neil shearer, naomi irish, chris watkins, alex durrant, suzanne henderson, leah catchpole, fiona fraser, tom barker, jose carrasco-lopez, geoff plumb). funded in part by uk research and innovation (ukri) biotechnology and biological sciences research council (bbsrc) core capability grant bbs/e/t/000pr9816. key: cord-322871-cf4mn0pu authors: o'keeffe, dara ann; bradley, dorothy; evans, linda; bustamante, nirma; timmel, matthew; akkineni, roopa; mulloy, deborah; goralnick, eric; pozner, charles title: ebola emergency preparedness: simulation training for frontline health care professionals date: 2016-08-08 journal: mededportal : the journal of teaching and learning resources doi: 10.15766/mep_2374-8265.10433 sha: doc_id: 322871 cord_uid: cf4mn0pu introduction: at brigham and women's hospital, we identified the need for a comprehensive training program designed to prepare frontline staff to safely manage a patient with ebola viral disease (evd). the primary goal of this program was to ensure the safety of staff, patients, and the general public by training staff in the correct use of personal protective equipment (ppe) before, during, and after care of patients with evd. methods: we delivered a 4-hour experiential training program to frontline health care professionals who would be expected to care for a patient with evd. the program occurred in a simulation center with multiple flexible spaces and consisted of demonstration, multiple skills practice sessions, and a patient simulation case. we analyzed completed preand posttraining questionnaires. the questionnaire assessed their subjective level of confidence in three key areas: donning and doffing ppe, performing clinical skills while wearing ppe, and management of a contamination breach. results: this program was effectively deployed in the stratus center for medical simulation over a 4-month period, with 220 health care professionals participating in the training and 195 participants completing the pre-/posttraining questionnaires. our intervention significantly increased the confidence of participants on each primary objective (p = .001 for all three stations). discussion: this interprofessional simulation-based program has been shown to be a well-received method of training clinicians to manage patients collaboratively during an evd outbreak. our intent is that the skills taught in this training program would also be transferable to management of other infectious diseases in the clinical setting. training staff in the correct use of personal protective equipment (ppe). many hospital-wide drills and training sessions were implemented in response to the recent ebola epidemic. here, we describe a simulation laboratory-based program that was used as the foundation training for frontline staff in the correct use of ppe for clinical care activities. epidemics have challenged human existence for millennia. there is evidence of widespread infectious outbreaks as early as 400 bce in ancient greece. in recent history, severe acute respiratory syndrome in the early 2000s and h1n1 influenza in 2009 resulted in significant worldwide morbidity and mortality. the medical community is now confronting two recent epidemics, the current west african evd outbreak that began in 2014 and, since 2012, an outbreak of middle eastern respiratory syndrome in south korea and china for which the world health organization reports 1,595 laboratory-confirmed cases, including at least 571 related deaths. all of these events have stressed the need for greater investment in building resilient systems to prepare for, respond to, and recover from emerging infectious disease epidemics. for nearly 20 years, simulation-based education has proven to be an integral part of medical training. since the early work of small et al., numerous studies have shown simulation-based education's invaluable contribution to the refinement of team structure, communication, and procedural skills. due to its emphasis on patient and staff safety, it has become an invaluable adjunct to traditional methods of teaching and training, especially in residency programs. since the 1970s, simulation has been used in epidemic response training. programs now include disaster exercises, semester-long courses for professional students, web-based simulation exercises, and large-scale high-fidelity curricula that utilize human simulators and actors. preparing for a response to an emerging infectious disease includes not only the conventional factors that characterize other disasters but also the need to become efficient in using clinical and procedural skills while wearing protective gear that has the potential to hinder flexibility, dexterity, and communication. simulation education provides a seamless stage for this type of training. at the neil and elise wallace stratus center for medical simulation and the center for nursing excellence at bwh, we have extensive experience in the simulation of many clinical events and skills across multiple disciplines. we consistently conduct interprofessional team and skills training sessions and have a team that frequently creates curricula for these programs. the overall goal of this program is to teach and enable practice of the appropriate donning and doffing of ppe according to accepted protocols and to teach the management of biosafety level 4 waste. the skills practiced will enable participants to perform or assist in the performance of standard clinical skills while wearing appropriate ppe. due to the austere nature of the clinical environment, this program is intended to be interprofessional. it is intended to enable and encourage collaborative care by providers who will need to participate in activities not typically required of them in less restrictive environments. as the primary goal of this course is to facilitate familiarity with the use and functionality of specific equipment and implementation of specific step-by-step processes, the most suitable instructional format is deliberate practice in a simulated environment. this program requires space to meet the needs of at least 12 participants rotating through multiple stations, some of which run concurrently. the participants will actively don and doff ppe, learn and practice the management of biosafety level 4 hazardous waste, and be provided an opportunity to manage, in interprofessional groups, a variety of routine medical processes and procedures while wearing ppe. participants should be hospital clinicians who have the potential to be exposed to and care for patients with evd in an isolated environment. these would include physicians, nurses, physician assistants, respiratory therapists, phlebotomists, and other relevant health care workers. the curriculum described hereafter is a 4-hour fundamental interprofessional training course designed for potential evd caregivers. the course consists of a concise didactic session and observation of a demonstration of donning/doffing evd-required ppe, active participation in the donning/doffing of ppe, course outline a concise schedule outlining the time and basic requirements for each section of the course is contained in appendix a. introduction of donning and doffing ppe setup: arrange table and chairs conference-style to enhance introductions, observation, debriefing, and evaluation processes. assign seating prior to class by placing nameplates with roles and designated groups around the table to ensure learning groups are interdisciplinary and to enhance conversations from the beginning of class. have a computer with audiovisual capabilities on hand, as well as adequate space for the demonstration of donning and doffing of ppe using an observer and a separate narrator. give each participant a precourse survey prior to the start of the class. participants and faculty introduce themselves, providing their name, institutional role, and personal expectations for the program. center layout and amenities are introduced. full attention of participants is requested, and a request to turn off beepers and telephones is made. the expectation that participants will stay for the complete 4-hour training is stated as is a short description of ground rules for the course: the management of patients with evd is evolutionary in nature. protocols will therefore be iterative. the training session is not the only training that people will be receiving, and a description of subsequent opportunities should thus be presented. up-to-date protocols are being taught as recognized by the institution, and participants are asked to delay specific questions concerning the protocols until they are actively participating in the don/doff exercise or until the end of the program. clarification regarding the purpose of the program is reinforced: except for safe donning and doffing and waste-management skills, no new clinical skills will be taught today; this is an opportunity to practice a variety of already-known skills while wearing ppe. the environment in which the ppe is worn will necessitate enhanced teamwork. as there is little chance of getting extra help expeditiously, a willingness to participate in patient care skills outside the normal realm of practice will be required. however, at no time will caregivers be asked to perform any skill outside their scope of practice. the schedule is explained. psychological safety of the simulation learning environment is ensured by guidelines for active participation, engagement, respect for fellow participants, and confidentiality (as per the simulation center's usual practice). three faculty members are required: a narrator, a clinician, and a safety monitor (third-party trained observer). obtain all necessary ppe. introduce participants to the don/doff checklist and required processes. a narrator briefly shows and explains each piece of equipment (participants are asked to hold questions until they move to the practice station). the narrator reads the checklist sequentially as the safety monitor assists the clinician in the donning/doffing procedure. provide space(s) for three teams to don and doff ppe. all donning and doffing accessories (chlorine-based wipes, armless stationary stool, ppe equipment, and waste containers) should be available. two faculty members are assigned to each group: one to serve as the checklist narrator and one to serve in the role of evd safety monitor responsible for assisting clinicians with the safe donning/doffing of ppe. the narrator reads the checklist slowly and methodically. the safety monitor assists participants in the active exercise of donning/doffing ppe. appendix b contains detailed checklists for donning and doffing ppe. note that these checklists were developed based on the bwh protocol for ebola management. some variations may exist at different institutions. three individual spaces with supplies specific to each are needed. see appendix c for a more detailed description of the equipment required for each station. two faculty members are needed at each station to assist in learning activities. individual requirements of the three stations follow. station a station a covers airway management, dressing care, iv infusion management, and urinary catheter care (± additional basic skills as required). airway management substation: a mannequin should be placed on a table or in bed wearing a nonrebreathing mask and must be able to be ventilated with a bag-mask ventilator and intubated orally, as well as having an iv arm with a crystalloid infusion for drug administration. ideally, the mannequin is attached to a pulse oximeter and cardiac monitor that can be manipulated to represent a desaturating patient; however, this is not necessary. also present should be airway equipment and medications (vials, prefilled syringes, alcohol wipes, and needles/infusion systems) that are typically employed in airway management at the institutions in which the participants practice. there should also be appropriate waste-disposal equipment. dressing care and iv infusion management substation: the mannequin can be medium or low fidelity on a table or a bed and have a dressing taped to an area of the skin. it should have an iv arm with a primary iv set infusing saline through an infusion pump. a 2-mg infusion of magnesium sulphate with appropriate accessories for piggybacking the infusion should be available. a dressing and tape should be available as well. there should also be appropriate waste-disposal equipment. urinary catheter care substation: on a table or bed, there must be a mannequin or task trainer in which a urinary catheter can be placed. urine should be in the bladder. a urinary catheter, a catheterization start kit, and a drainage bag should be available. there should also be appropriate waste-disposal equipment. for each of the stations above, interprofessional groups of three to four learners will perform the routine clinical care tasks set up in the station. each participant should perform tasks appropriate to his/her discipline and training, but all will practice assisting each other, as mastering communication and dexterity while wearing the ppe is a core learning objective of station a. setup: this station should be equipped with mops, solutions, appliances, waste bins, and waste bags that will be employed in the management of biosafety level 4 waste within the institutions in which the participants practice content: see appendix d for detailed content. station c station c features human patient simulation. equipment/environment: a medium-to high-fidelity mannequin is dressed in hospital garb and is laying at 45° in a bed with a blanket covering it. the mannequin is not initially attached to the cardiac monitor or pulse oximeter. the mannequin will have a urinary catheter with a drainage bag that has 700 ml of fluid simulating urine hanging off the side of the bed. the mannequin will be placed on typical hospital linens with an absorbable underpad that has material simulating stool on the pad. equipment to initiate and secure a peripheral iv and an iv infusion pump with which to initiate the iv infusion must be present. the rest of the room should appear as a patient isolation room. personnel: the simulation specialist runs the mannequin. one faculty member is the patient's voice via microphone from a control room. as this is a low-acuity scenario, one faculty member should suffice to both perform as the patient and observe for later debriefing. however, if a second faculty member is available to be the observer/debriefer, that would be of additional benefit. no confederates are required in the room. assessment: the participants are observed for their communication with the patient and with their colleague in the room and for their performance of simple clinical tasks, such as attaching the patient to monitors, cleaning the soiled patient, and disposing of the soiled materials in the correct way. faculty may choose to add additional tasks to the scenario such as insertion of an iv line or managing a fluid spill on the ground. faculty may refer to the protocols for such tasks included in this publication or reference their own protocols or checklists for specific tasks from their institution. however, the principle learning objective is that participants are able to perform already-known tasks within the confines of the ppe and that all procedures for infection control are strictly adhered to. donning and doffing the ppe may also be included as part of the scenario or as a separate station depending on the time available. debriefing: the debriefing consists mostly of a facilitated discussion by participants on what the expected and unexpected consequences of having the ppe in place were on their ability to perform basic patient care tasks. faculty identify errors or lapses in protocol that they observed and ask participants to outline what they feel contributed to those incidents. patterns and difficulties with communication should also be debriefed, with an emphasis on how the team performed given the constraints of the environment and the ppe. we did not use video playback in our debriefing session as time was limited and not all of the interprofessional faculty were familiar with our video playback software. however, it should be considered a valuable addition to the debriefing session if available and if faculty are trained in its use. see appendix e for full details of the simulated patient scenario's setup, content, and debrief. final doffing at the conclusion of the final skills station for each participant, final doffing of ppe takes place. setup requires ample room marked by tape to mimic both a hot zone and a warm zone. appropriate doffing accessories (chlorine-based wipes, armless stationary stool, waste containers, and receptacle for ppe) should be available in the room. see appendix c for a more detailed description of the equipment required. appendix b contains the doffing checklist. this program was effectively deployed in the stratus center for medical simulation over a 4-month period in 2014-2015. participants in our 4-hour program included physicians, nurses, respiratory therapists, laboratory technicians, and ancillary staff. two-hundred and twenty health care professionals participated in the training. all were asked to complete the same three-question survey before and after participation in the training program. the survey assessed their subjective level of confidence in three key areas: management of a contamination breach, performing clinical skills while wearing ppe, and donning and doffing ppe. these questions were answered using a 5-point likert scale with the anchors not at all confident and extremely confident. replies were converted to their numerical value on the likert scale, and a one-way analysis of variance was performed to calculate the p value. we analyzed completed pre-and posttraining questionnaires from 195 participants. prior to participating in the program, 61%, 67%, and 66% of participants rated their confidence level as not at all confident or a little bit confident in management of a contamination breach, performance of clinical skills in ppe, and donning and doffing, respectively. after completing the course, 96%, 97%, and 98% of participants rated their confidence as to some extent, quite a bit, or extremely confident (figure 1 ). our intervention significantly increased the confidence of participants on each primary objective (p = .001 for all three stations). means and p values for confidence scores in each station are presented in table 1 . overall, 90% of participants rated the quality of the simulation on the program as good or outstanding, and 97% rated the faculty as good or outstanding. these results are outlined in figure 2 . this program was successfully deployed and well received by the health care professionals in our institution. as it was a newly designed program for our center, there were many lessons learned along the way. we concede that the design of the program is faculty intensive. however, it was important to have a high faculty-to-participant ratio in order to replicate the high level of supervision that occurs when monitors supervise donning and doffing techniques in the clinical setting. potentially, faculty requirements could be reduced by using core teaching faculty in the monitor role in the one-to-one donning and doffing sessions. participants could also perform this role, provided they were instructed in the monitoring process in advance. we utilized a high-fidelity simulation environment for our simulated patient experience station, but most of the course objectives could be achieved in a lower-resource setting by omitting this station if the facilities are not available. the 4-hour program length was necessary to allow for repeated practice of a very complex donning and doffing process with many specific steps to complete. one difficulty we encountered was the continuously evolving protocols for ppe. protocols were revised as newer equipment was received, limited by a challenged supply chain as demand outweighed supply from numerous vendors from october 2014 until february 2015. for example, based on drills and exercises, we converted from one respirator brand to another that provided clearer communication and improved cooling. these protocols may vary between institutions and may be revised and altered within single institutions over time. it is important that centers implementing this course establish what the local protocols for ppe use are and adhere to them in order for the training to be applicable to the health care professionals in that institution. at the same time, we also encourage institutions to follow nationally and internationally accepted protocols as closely as possible. while we have solicited and analyzed feedback from a large number of participants, one of the questions in our survey referred to a skill not directly covered in the training. when originally designing our program, we hoped to include full training on management of a breach. however, it was felt that this was a higherlevel training objective, more suited to the monitors (trained clinical observers), and therefore, this content was removed from the course. our participants were instructed that if a suspected breach occurred, they would be directed by their trained observer. we decided to leave this question in our feedback survey 16 and found that confidence was increased in this area. we feel this represented a level of confidence in the system of donning and doffing in pairs with an observer guiding. also, we have not evaluated durability of the training by assessing long-term retention of the skills we trained for. ideally, implementation of this program should include shorter sessions of follow-up training at regular intervals. no clear guidance for frequency and modality of training for health care workers in this intensive scheme exists, and our models are based on information garnered from national centers of excellence (emory university, the university of nebraska). nongovernmental organizations' national and international efforts should be directed toward outlining standards to define competency, training modalities (functional and tabletop exercises, simulation, web-based training, didactics, etc.), and frequency of those modalities. medicine can look to other industries, including aviation, as the gold standard for competency measurement and evaluation. our interprofessional simulation-based program has been shown to be a well-received method of training clinicians to manage patients collaboratively during an evd outbreak. our intent is that the skills taught in this training program would also be transferable to management of other infectious diseases in the clinical setting. this training should form part of a linear program with subsequent shorter courses at regular intervals aimed at ensuring retention of skills over time. dna examination of ancient dental pulp incriminates typhoid fever as a probable cause of the plague of athens summary of probable sars cases with onset of illness from 1 geographic dependence, surveillance, and origins of the 2009 influenza a (h1n1) virus demonstration of high-fidelity simulation team training for emergency medicine simulation-based education improves quality of care during cardiac arrest team responses at an academic teaching hospital: a case-control study enhancing patient safety during pediatric sedation: the impact of simulation-based training of nonanesthesiologists for the saem technology in medical education committee and the simulation interest group epidemic simulation for training in public health management investigating an epidemic: a seven-part simulation used in teaching epidemic investigation simulation immersive simulation education: a novel approach to pandemic preparedness and response high-fidelity multifactor emergency preparedness training for patient care providers using a web-based simulation as a problem-based learning experience: perceived and actual performance of undergraduate public health students improving emergency preparedness system readiness through simulation and interprofessional education what a disaster?! assessing utility of simulated disaster exercise and educational process for improving hospital preparedness centers for disease control and prevention web site emergency department processes for the evaluation and management of persons under investigation for ebola virus disease none to report. presented as a poster at the society for academic emergency medicine annual meeting, may 2015. reported as not applicable. key: cord-253138-b08f64lu authors: ponsero, alise; bartelme, ryan; de oliveira almeida, gustavo; bigelow, alex; tuteja, reetu; ellingson, holly; swetnam, tyson; merchant, nirav; oxnam, maliaca; lyons, eric title: ten simple rules for organizing a data science workshop date: 2020-10-22 journal: plos comput biol doi: 10.1371/journal.pcbi.1008226 sha: doc_id: 253138 cord_uid: b08f64lu nan computational literacy is now a critical skill in most areas of research and commerce [1] . there is a demonstrated need for data science training to bridge domain gaps between physical, biological, and computer sciences [2] . these training sessions can cover a large number of topics such as the use of computational tools in data storage interoperations or the reproducible analysis of large and complex data sets. short (less than a week long), hands-on workshops offer critical skills development for scientists, at all career stages, outside their work schedules. however, training workshops can be particularly challenging to develop and plan. often, such events require coordinating a large team of organizers and instructors [3] . facilitating a data science workshop poses unique challenges due to the field's large methodological scope. in particular, these trainings need to accommodate participants' heterogeneous scientific and computational backgrounds, while encompassing the diversity of computational resources and best practices. our baseline framework stems from the philosophy and structure used by the carpentries to teach data and software core skills through hands-on workshops [4] . their pedagogy utilizes short workshops focused on a specific domain within the contextual framework of the topic being taught (e.g., the complete life cycle of data). the carpentries curricula for workshops are iterative, and inclusive to people from any background, with no prior experience in the topic area. their lesson plans are often an excellent place to start finding material when developing a new workshop, though there are many sets of open source materials. here, we discuss the challenges of organizing participatory data science training and provide 10 simple rules to facilitate inclusive workshops. each of these rules can be considered independently, but they are written as a progression of ideas that refer back to previously discussed points. rules 1-6 focus on training material development. rule 7 is on testing the developed workshop material. rules 8 and 9 discuss important considerations when running the workshop. finally, rule 10 focuses on the importance of continuously evaluating and learning from past workshops to inform future pedagogy. while short-format workshops are increasingly popular, it should be noted that 1 study showed little difference in long-term performance of graduate students [5] . however, this study notes that longer formats have shown significant positive outcomes, and the carpentries wrote a thoughtful response [6] . in addition, the authors reference research describing thresholds of learning for graduate students that must be crossed prior to learning specific data analytical skills [7] . while further research into this area is warranted, organizers of data science workshops may consider offering the same material with more spacing between lessons. an entire workshop can be challenging to be organized and taught by a single person. the breadth of knowledge required and cognitive biases of a single person could derail a workshop entirely. therefore, the organization and planning of such workshops necessitate collaboration, as the perspective of different people typically allows to develop a more inclusive training material. choosing the right people with whom to collaborate is critical, and using campus or organizational networks to connect instructors assures common interests are met. this also facilitates the creation and maintenance of a set of common goals and shared vision across all team members. we believe that the team should develop and document 4 critical areas of the workshop: (1) the vision of the workshop; (2) the goals of the workshop; (3) the expectations from the instructors; and (4) who the target participants are. as outlined in table 1 , we refer to the "goal" of a workshop as the broad concepts that participants should expect to learn from the training. in contrast, the "vision" of the workshop should address why these goals are important; the vision details how the skills acquired will help the participants and meet the values of the training program. documenting the 4 critical areas will reduce miscommunication between team members, which is critical for workshops lasting more than a few days, or those that are part of a continuous series. it is critical to acknowledge the time and effort required to prepare, test, and teach the workshop. these events are a great opportunity for students and researchers to develop their teaching and communication skills. importantly, newcomers to instruction should be welcomed and mentored. new instructors may want to review the instructor training material developed by the carpentries [8] to get familiar with inclusive teaching methods. we recommend that experienced instructors focus on setting the overall tone for the workshop, while providing opportunities for less experienced people to assist in teaching materials. the overall purpose of the workshop. for example, the vision of a git workshop might be to increase participants' abilities to perform reproducible research. the broad concepts that participants should learn that support the vision. for example, a git workshop that introduces participants to version control concepts can increase participants' ability to understand and track how their data and code have changed over the lifespan of a project-ultimately resulting in more reproducible research. learning objectives the specific skills or operations that participants learn and practice that, collectively, accomplish a goal. for example, in a git workshop, learning objectives might include creating branches, staging changes, merging branches, handling merge conflicts, and pushing to or pulling from remote repositories. together, these learning objectives accomplish the goal of introducing participants to version control concepts. blameless retrospectives originate from agile-based software development. their goal is to create a group culture of psychological safety and accountability and facilitate continuous learning. in these retrospectives, it is often useful to refer back to the project management plan and determine which strategies facilitated learning objectives, goals, and contributed to the workshop's vision. in order to alleviate the workload associated with developing the workshop's training material, we recommend a modular approach for developing the teaching material. in this framework, each training module is created and taught by independent teams. the team should refer back to the common guideline developed for the overall workshop (rule 1) while defining each module's scope and goals. we believe that smaller teams and modularity of lessons facilitate efficient project management practices. it is important for the instructors to establish a schedule for the development of training modules as well as provide time for testing new materials. organizational management tools like zenhub (https://www.zenhub.com), trello (https://trello.com), or basecamp (https://basecamp.com/) can help the coordinator track progress while the workshop is in development. as workshop development matures, these tools can also provide a place to develop backup plans for alternative locations, equipment, instructors, etc. this is also important when teaching online workshops, which can face their own specific technical hardships. ultimately, good project management tools ensure overall workshop leadership can track all teams' curricula developments, while also creating a unified communication framework and an explicit schedule of the workshop events. we recognize a potential pitfall of developing modular training material (rule 2) could be differences in presentation style, supporting documentation, and learning objectives. connecting learning objectives from different training modules taught by different instructors requires a large effort in coordination and communication. therefore, a person should be designated as the overall coordinator to ensure learning objectives from individual training modules are connected. for smaller workshops, this coordinator may also work in an instructor team. the coordinator's work can be facilitated through project management tools outlined in rule 2, and ideally, the coordinator would act as the project manager. finally, the workshop coordinator should ensure each session and learning objectives build toward the overall vision and goals of the workshop (rule 1). the workshop coordinator ensures the connection of the different modules developed by the team (rule 3). however, these connections should also be evident to the learner-it can be easy for both instructors and participants to lose sight of learning objectives, leading to many other pitfalls. an overview of skills in each session helps ground participants' expectations and can serve as a reminder to instructors of the most important points that they need to cover. the interrelatedness of the modules covered should be referenced as each session closes, which should be connected back to the vision and goals of the workshop (rule1). the learning objectives can be defined as the specific skills that participants will learn during the workshop. in a git workshop, the learning objectives might include creating branches as well as pushing to or pulling from remote repositories. the workshop's main learning objectives could be presented as an overview at the workshop's opening, along with introducing the instructors, the overall schedule, and a discussion on the code of conduct. however, the learning objectives should also be emphasized during and after each module and recapitulated during the workshop's closing remarks. at the beginning of each training module, instructors should clearly describe learning objectives and the skills acquired during this session (table 1) . a record of learning objectives should be provided in a document specifying low-level objectives (e.g., learning the commands "ls" and "cd") as well as high-level workshop goals (e.g., learn to use commands together for automation of computational tasks). sharing these documents ensures all instructors are made aware of other sessions' objectives, avoiding overlap or gaps in knowledge across sessions. data science workshops will have a blend of conceptual overviews (e.g., why a particular set of technologies is used and how they fit together), best practices (e.g., why containerization is useful for reproducible computing), and technical hands-on exercises (e.g., pulling docker containers and creating new dockerfiles). across the developed training modules (rule 2), active learning helps participants understand the rationale behind learning objectives and technical choices of the module (rule 4). felder and brent (2009) define active learning as anything course related that all students in a class session are called upon to do rather than simply watching, listening, or taking notes [9] . in addition, the instruction should provide learners not only with practice implementing technologies but also how to find help autonomously to resolve technical issues after the workshop adjourns. the active learning environment is enhanced by developing group or live coding problemsolving activities in a physical environment that facilitates cooperation (e.g., tables, computer displays and whiteboards, and breakout areas) [10] . in online workshops, these activities can be done by creating small subgroups of participants working together or with individuals working simultaneously on the same problem set. it is essential to recruit helpers/facilitators familiar with the technologies to ensure adequate workshop pacing and assist with unforeseen technical problems [11] . additionally, it is important to allow for helpers and facilitators to easily move between individuals/groups and track their progress, which can be particularly challenging to monitor in an online setting. instructors may underestimate the time required for an active learning module. this is especially challenging when instructing in a heterogeneous computing environment with multiple software code stacks. instructors should be mindful of the pace and watch for participants falling behind the rest of the group. it is important to ensure participants feel comfortable in speaking out with their difficulties, which can be onerous in some online settings. it can be beneficial to encourage participants to keep their cameras on to ensure engagement and allow a better gauge of their status. this may be impossible with larger groups or with slow internet connections. additionally, we recommend providing instructions before the workshop on how to use interactive features of online video conference tools (e.g., attendees raise hands, polling, and breakout rooms). workshop participants are likely to come from diverse scientific backgrounds with varying levels of computational literacy. it is critical to understand their expectations and evaluate their skill sets to ensure that the workshop material and active learning sessions meet the needs of participants [3] . in addition, instructors must have empathy for participants and consider the learner's expectations when conducting their presentations. when organizing virtual workshops, keep in mind that participants may have limited resources that can hinder their learning experience (such as having a small, single monitor, slow computer, or limited bandwidth). in addition, it is important to make sure that the workshop is accessible for all participants [12, 13] . we recommend providing a pre-workshop survey to participants using the workshop goals (rule 1) to shape the questions. if the workshop is part of a series, questions like "are you participating in the next workshop on topic x that builds from this content?" can better link workshop contents over disparate time scales. interested readers can find here an example of survey here: http://bit.ly/ds-qs. collecting participant's feedback allows instructors to better develop active learning modules matching the participants' domains of interest (rule 5) and provide information for refining learning objectives (rule 4). prior to your workshop, it is important to test new teaching materials with naïve users (defined as anyone with no prior experience) in the specific domain, software, or technique being taught. the material should be complete and be easily followed by someone who is new to the field. particular care should be taken during this test to ensure the lesson will fit in the allotted time. there should be no gaps in knowledge and/or lesson steps. review the connections of learning objectives for each module to the needs identified in a pre-workshop survey (rule 6). while pretesting the learning material is critical for the workshop's success, it is also extremely time consuming. we therefore advise all instructors to deliver their material at least 2 weeks prior to the workshop to ensure sufficient time for cognitive walkthroughs. the particularities of each operating system should be taken into account when the participant is expected to provide their own laptop. in particular, installation procedures should be detailed for each platform. if the learner is expected to complete the computational tool installation prior to the workshop, plan at least an hour or 2 on the first day to ensure that all required software and dependencies are configured. if the workshop provides computers, a system support technologist should be available at the beginning of the workshop to help with any system issues [3] . it is important to note that many data science tools and platforms are complicated stacks of software, which can be difficult to install from scratch. it may be important to preinstall these on computers used in the workshop or provide preconfigured virtual machines and/or containers (docker (https://www.docker.com/)/singularity (https://singularity.lbl.gov/)). the chosen toolset informs skill prerequisites for participants prior to a module being taught (e.g., linux command line, logging into remote servers, etc.). these skills will need to either be covered early in the workshop or be expected as workshop prerequisites. be mindful that workshop material should be understandable for all learners (their prior knowledge should be informed by rule 6) . presentation slides should include the most important points, since oral comprehension can be augmented with written notes. it is important for instructors to speak slowly, clearly, and avoid "going off script." we define "going off script" to be the inclusion of technical material outside the scope defined by the workshop (rules 2-5). if instructors include steps not clearly documented in the supporting material, this could lead to confusion, take extra time, and be particularly difficult for nonnative language speakers. such areas can be identified before the workshop during cognitive walkthroughs (rule 7). all instructors must understand that adding any additional information outside the written material and learning objectives of a module may be of little value to participants. participant questions may lead to an instructor "going off script," and while these discussions may be useful, the instructor should reserve the right to address their question during a dedicated time for questions and answers or one-on-one during a break. however, this is not meant to impose any restrictions on personal style of presentation. we strongly encourage presenters to find their own voice and not simply read bullet points on a slide. dynamic and interactive presentation is a skill that the instructors are practicing and honing while teaching these sorts of workshops. in addition to developing their own teaching material, the instructors should strive to reference external resources available to participants. these workshops often provide foundational skills, but adding links to external resources will empower participants to continue their learning according to their needs and interests [3] . this also allows engaged or more advanced participants to access content beyond the scope of the workshop. in addition, these resources can be referenced if questions cause the module to go off script (rule 8). the pre-workshop survey (rule 6) ensures extra content is tailored to extend the participants' learning trajectory beyond the workshop. when all rules of workshop organization are met by the organizers, the participants will leave with a sense of starting a journey toward a new long-term goal for themselves or their research group. workshops are rarely developed perfectly from the onset; learning from past experiences is critical to improving workshop content. as such, it is important to have surveys for each module and the workshop as a whole [14] . we recommend reserving time for these to be completed during the workshop. for example, if holding a multiday workshop, set aside 10 minutes in the morning of each day to let participants review the previous day's modules. these day-by-day evaluations facilitate tracking potential issues and implementing possible course corrections. in addition, it is important to hold a blameless retrospective (table 1 ) [11, 15] . there are several ways to conduct a blameless retrospective, but generally, they should be critical, relaxed, and provide a forum to identify what worked well, what didn't work well, and what should be done differently the next time the workshop is taught. when the retrospective concludes, there should be a list of action items to help with the planning and execution of future workshops. these assessments should aim to inform the practice of the next workshop and provide guidance for the instructors, allowing them to revise their style and approach in the future, and therefore should be documented and made accessible for future instructors. this practice, and revisiting rules 1-9 at this phase, will ensure that organizers, instructors, and helpers continue to refine, rather than reinvent, prior workshops. in particular, workshop organizers should pay attention to differences in learning objectives between iterations of workshops. this practice allows instructors to not be as constrained by prior editions of the workshop, since computational tools and data science are rapidly changing fields. this paper was developed and written before the coronavirus disease 2019 (covid-19) pandemic, which has forced many workshops and training into a virtual environment. we believe that all of the rules presented here are still useful in guiding the organization and implementation of a workshop in a virtual environment but do not cover all the unique challenges remote training face. the presented rules aim to help create a well-organized workshop with clear intentions and an empathetic environment in which participants feel both productive and understood. this focus on accessibility is particularly important to reduce the personal distance inherent in online workshops. additionally, these recommendations should guide organizers to provide complete and accessible materials for reference, a point particularly important for remote teaching, where home life can frequently interrupt participation. although not discussed here, it is also worth noting that instructors of online workshops should design their teaching with an extra effort on interactivity and checking for participants' understanding frequently. there are many resources available to help increase interactivity of online workshops, and we encourage the reader to try and choose the platform and tools that best meet their needs. we cannot wait to read the 10 simple rules papers summarizing what the community will learn about remote teaching during these exceptional times. computational thinking and literacy unmet needs for analyzing biological big data: a survey of 704 nsf principal investigators ten simple rules for developing a short bioinformatics training course data carpentry: workshops to increase data literacy for researchers null effects of boot camps and short-format training for phd students in life sciences when do workshops work? a response to the "null effects" paper from feldon et al. [internet]. software carpentry performance-based assessment of graduate student research skills: timing, trajectory, and potential thresholds. stud high educ active learning: an introduction. asq high educ brief ten simple rules for organizing and running a successful intensive two-week course ten simple rules for running interactive workshops removing the barriers for students with disabilities: accessible online and webenhanced courses make online teaching accessible with inclusive course design. disabil compliance high educ ten simple rules for measuring the impact of workshops a review of small and large post-mortem analysis methods the authors would like to thank ua health sciences for their support of the data science fellows program at the university of arizona, cyverse (nsf dbi-1743442) for participation in and observation of their workshops, and the carpentries (https://carpentries.org/) for leading the charge in developing and delivering various computational workshops to help domain scientists learn the best practices and techniques for managing and analyzing their data. key: cord-281344-iswbgqqe authors: jonker, leonie t.; lahr, maarten m.h.; festen, suzanne; oonk, maaike h.m.; de bock, geertruida h.; van leeuwen, barbara l. title: perioperative telemonitoring of older adults with cancer: can we connect them all? date: 2020-09-04 journal: j geriatr oncol doi: 10.1016/j.jgo.2020.08.008 sha: doc_id: 281344 cord_uid: iswbgqqe objectives: although the increasing cancer incidence in older patients is widely recognised, older patients remain underrepresented in clinical cancer trials and ehealth studies. the aim of this research is to identify technological and patient-related barriers to inclusion of this population in a clinical ehealth study. material and methods: this is a retrospective analysis of a prospective cohort study with older patients (≥ 65 years) undergoing cancer-related surgery, who were identified for a perioperative telemonitoring study. reasons for ineligibility and refusal had been prospectively registered. characteristics and postoperative outcomes were compared between participants and non-participants. results: between may 2018 and march 2020, 151 patients were assessed for eligibility, resulting in 65 participants and 86 non-participants. the main reason for ineligibility was lack of internet access at home (n = 16), while main reasons for refusal were perceived high mental burden (n = 46) and insufficient digital skills (n = 12). compared with participants, non-participants were significantly older (mean age 75 vs. 73, p = 0.01); more often female (64% vs. 35%, p = 0.00), unmarried (42% vs. 8%, p = 0.01) living alone (38% vs. 19%, p = 0.02); had a higher asa classification (43% vs. 19%, p = 0.00); often had polypharmacy (67% vs. 43%, p = 0.00); and were more often discharged to skilled nursing facilities (0% vs. 15%, p = 0.00). conclusion: our results confirm the underrepresentation of older female patients with little support from a partner and higher comorbidity. we should be aware of technological and patient-related barriers to including older adults with cancer, in order to avoid further dividing patients with low and high digital health literacy. older patients (over the age of 65) represent the majority of global cancer cases, with a predicted absolute number of 14 million worldwide by 2035 [1] . surgery is a fundamental part of treatment in more than 80% of cancer cases, as well as for older patients [2] . higher age alone does not necessarily increase the risk of adverse postoperative events, but the prevalence of age-associated comorbidities and frailty (age-related cumulative decline in multiple physiological systems) does increase this risk [3] . frail older patients are three to four times more likely to develop postoperative complications compared with non-frail older patients [4, 5] . moreover, the occurrence of complications has a considerable impact on the quality of life and the survival of older patients [6] . together with the fact that hospital admissions have been shortened due to changes in modern health care [7] , this highlights the necessity of prevention and early detection of postoperative complications in this population. new digital technologies (i.e., ehealth) are emerging rapidly in health care to promote patients' self-management and engagement and improve patient-centred cancer care [8] . the interest in remote care delivery by ehealth has increased even more during the current covid-19 pandemic, as remote consultation decreases the risk of spreading the virus and could decrease the pressure on health care resources [9, 10] . additionally, ehealth is used to remotely monitor patients' postoperative recovery in surgical wards or at home after hospital discharge [11, 12] . this so-called telemonitoring could contribute to timely detection of postoperative complications and therefore potentially decrease the impact of these complications in frail older patients with cancer [13] . although the increasing incidence of cancer in older patients is widely recognised, these patients remain underrepresented in clinical cancer trials [14, 15] . they are excluded from clinical cancer trials because of study restrictions, comorbidity, polypharmacy, or physicians' attitudes [16] . older patients are also underrepresented in most perioperative ehealth intervention studies. this underrepresentation of older, and often frail, patients leads to a bias in research outcomes, non-generalisable results and inequality in healthcare provided [17] . this poses a real risk that ehealth interventions will remain geared towards a younger, more flexible population, and will result in the exclusion of the population likely to show the greatest benefit. also, ehealth literacy is known to be lower among older adults with cancer compared with their younger counterparts [18] . the covid-19 pandemic has further increased the need for new digital solutions in health care and clinical research [9, 10] . it is thus of the utmost importance to identify barriers to participation in clinical ehealth trials among the older population. when these barriers are known, both clinical ehealth trials and ehealth applications may be adjusted so that they may benefit the entire oncological population, including frail older patients. in a prospective cohort study with the aim of assessing feasibility of perioperative telemonitoring of older patients with cancer, we were able to include approximately half of the identified patients. to investigate possible technological and patient-related barriers to participation, we analysed reasons for ineligibility and refusal and differences in characteristics of non-participants and participants. to explore the impact of possible benefits a postoperative telemonitoring intervention could provide for our population, we additionally compared the postoperative outcomes between non-participants and participants. this study is a retrospective analysis of a prospective cohort study with older patients undergoing cancer-related surgery, who were identified for a perioperative telemonitoring study (netherlands trial registration number: nl 8253) [19] . the prospective telemonitoring study was conducted in a tertiary referral hospital in the north of the netherlands and approved by the local medical ethical committee (registration number: 2017/286). in consultation with legal officers at our local medical ethical committee we obtained permission to collect additional routine data on care of all identified patients. the principal reason was to collect reasons why candidates did not participate, to identify potential modifiable factors to improve on this situation for future studies. also, it was evaluated that obtaining additional consent was perceived too burdensome for patients and/or carers. we had identified patients over the age of 65 with an indication for oncological resection of a solid malignant tumour. patients had been approached at the hospital's outpatient clinic or by telephone in the period between may 2018 and march 2020, after they were identified for the study by a surgical nurse or surgeon from the treatment team. patients were eligible if they had internet access at home. exclusion criteria were severe auditory, visual and cognitive impairment that were expected to impair the ability to use digital technologies or hear/understand the explanation by telephone; being wheelchair-or bed-ridden; having contact dermatitis; insufficient understanding of dutch; and emergency surgery. participants had been assessed at three moments in time: before surgery, before hospital discharge and at three months after surgery. participants had used a mobile application connected to various electronic monitoring devices. physical activity had been measured using an accelerometer-based wearable activity monitor (fitbit charge 2, fitbit inc., san francisco, ca, usa) during the entire study period. for two weeks after hospital discharge, postoperative recovery had been monitored using the mobile application and additional devices to measure temperature, blood pressure, heart rate, pain, and the occurrence of other postoperative symptoms. due to the observational character of the study, no intervention followed when a deviation had been detected in monitored data. patients had only been contacted by telephone by the research physician if no data was transferred or if alarming parameters had been observed. following the latter, the treating physician would have been contacted if there was a need for medical consultation. we had implemented several strategies in our study design to minimise refusal, based on solutions presented in previous studies for approaching older patients [20] . first, we recognised the importance of adequate communication, especially with older patients. we preferred face-to-face contact to inform patients, offered clearly written study information and emphasized that the study case manager in charge was easily available by telephone for any questions during the study period. second, we involved patients' family members in the recruitment process, as family members have a major influence on the decision to participate. the study information at the outpatient clinic was preferably provided with a family member present. the supporting role of the family member was emphasized before the start of the study, and if the patient preferred that communication about study participation or technological explanation was given to a family member, this family member was approached by telephone. third, we decided to plan follow-up visits with patients at home or schedule appointments to coincide with planned hospital visits because additional hospital visits discourage patients from participating [20] . these strategies to minimise refusal were also meant to promote study completion. family members were involved in technical actions. technology support was provided by the case manager throughout the whole study period by telephone and if necessary, at home or coinciding with planned hospital visits [19] . reasons for ineligibility and refusal had been prospectively registered in a database by the case manager directly after assessing eligibility or after approaching patients for the prospective telemonitoring study. relevant demographics, preoperative indicators of frailty, surgical data and postoperative complications of participants were prospectively collected in face-to-face assessments and from hospital medical records. routine care data about non-participants was retrospectively collected from hospital medical records to evaluate health outcomes. no additional non-consented patient data was collected outside routine care. collected data on the somatic domain of frailty included preoperative physical status assessed by an anaesthesiologist (american society of anesthesiologists [21] [asa classification]), comorbidity (charlson comorbidity index [22] ) and, polypharmacy (>4 different types of medication [23] ). nutritional status was assessed using body mass index (bmi). marital status and housing data were collected to indicate social status. data on the psychological domain was collected from the routine consultation with a nurse at admission and registered in the medical records; including i) concerns about hospital admission, ii) anxiety that influenced daily life and, iii) the use of any psychiatric medication. functional status had been determined using the reported katz activities of daily living (adl [24] ) score. data on tumour location, recurrence of disease, primary malignancy, neoadjuvant therapy, and anaesthesia time was collected. postoperative outcome measures found in the medical records of the individual treatment centre, were collected from its administration. postoperative outcome measures included postoperative icu (intensive care unit) admission, length of hospital stay, complications related to surgery in-hospital and within 30 days after discharge (clavien-dindo classification ≥2 [25] ), unplanned hospital readmission to the individual treatment centre and outside the treatment centre within 30 days after discharge, referral to a nursing home or skilled nursing facility (snf) post-discharge, and overall survival at three and twelve months. we compared characteristics and outcomes from non-participants and participants using an independent sample t-test for parametric continuous data, mann-whitney u test for non-parametric continuous data, and pearson's chi-squared or fisher's exact test for categorical data. a pvalue <0.05 was considered statistically significant. data on baseline characteristics was only used for analysis if it was available for more than 90% of both groups. we compared postoperative outcomes for all patients and per subgroup, classified by type of primary malignancy (gastro-intestinal, gynaecological, or other oncology). the participants and non-participants who underwent surgery were included in overall survival analyses using the kaplan-meier with log-rank testing. data was analysed with ibm spss statistics version 23 (ibm corporation, armonk, ny). out of 151 patients who were assessed for eligibility, 65 patients consented to participate, and 86 patients did not participate (fig. 1) . of the 86 non-participants, 21 patients were not eligible for participation and 65 patients did not want to participate. technological barriers to participation were lack of internet access at home (n = 16) and the perceived inability to work with electronic devices and mobile applications (digital illiteracy, n = 12). the main patient-related barrier was a perceived high mental burden (n = 46). baseline characteristics of participants and non-participants are presented in table 1 . compared with participants, non-participants were significantly older and more often female (table 1 ). in addition, non-participants had a significantly higher asa classification, more polypharmacy and less social support based on data regarding marital status and housing circumstances. nonparticipants were more often adl-dependent compared with participants, although this difference was not statistically significant. from the 65 patients who consented to participate, seven patients were excluded before surgery and 43 patients completed the study. reasons for study drop-out were cancellation of surgery, logistic issues regarding baseline assessment, or the combination of a high burden of disease and treatment and performing measurements at home. results of our feasibility study demonstrated that the compliance of performing vital sign measurements and completing electronic health questionnaires was lower than synchronising physical activity (fitbit-)data, suggesting that these aspects were challenging for the patients [19] . surgery was cancelled for four participants and six non-participants, resulting in analysis of postoperative outcomes of 61 participants and 80 non-participants ( fig. 1; table 2 ). compared with participants, non-participants had similar complication rates. difference in readmission rates were not statistically significant (23% vs. 15%, p = 0.27). in sub-analysis, these differences in postoperative adverse event rates tended to be larger in the patients who underwent gastro-intestinal oncological surgery, although the difference remained not statistically significant. non-participants were significantly more often discharged to an snf compared with participants. the twelve patients who were discharged to an snf were significantly older (mean age 79.0 versus 73.6 years old [p = 0.01]), had a higher asa classification (asa 3-4 58% versus 29% [p = 0.05]), used more medication (% polypharmacy 92% versus 50% [p = 0.00]) and were more often living alone or in a nursing home before surgery (50% versus 30%, 17% versus 0% [p = 0.00]). the survival analysis in fig. 2 demonstrates no difference in survival between three and twelve months for non-participants compared with participants (p = 0.37). in this prospective cohort study, we investigated technological and patient-related barriers to participation of older patients with cancerrelated surgery in a perioperative telemonitoring study. main inclusion barriers were ineligibility due to lack of internet access at home, refusal due to digital illiteracy (the perceived inability to work with electronic devices and mobile applications), and a perceived high mental burden. non-participants were older, were more often female, had a higher asa classification, used more medication, and were more often living alone compared with participants. about one fifth of participants and non-participants experienced a serious complication after hospital discharge. in addition, we observed significantly more snf referrals for non-participants compared with participants. no statistical differences were observed in other postoperative outcomes between participants and non-participants. in our study, 11% of all patients who were assessed for eligibility could not participate because they had no internet access at home. this corresponds with statistics provided by the dutch central bureau of statistics [26] . although access to the internet in the netherlands has improved considerably in the past decade, in 2019 6% of the dutch population aged 65-75 and 23% of people aged over 75 still had no internet access at home [26] . another 8% of all patients who were assessed for eligibility refused because they thought they possessed insufficient digital skills or felt uncomfortable with acquiring these skills for study purposes. studies have confirmed that the main reason people refuse to learn new technologies is anxiety about using them [27] . in addition, ageing causes a decrease in self-efficacy, memory and speed of learning [27] . however, if the perceived advantages of new digital technologies are large and relevant enough and family or peer support is present, older adults are able to overcome their fears and start learning to use new technology [28, 29] . one of the main reasons for refusal was a perceived high mental burden, which might be related to technological barriers as well. an inclusion rate of 50% (65/130) was achieved through several strategies in our study design such as face-to-face contact, involving family members in the recruitment process and, flexible home study visits [20] . the difference in characteristics of participants and non-participants in our study corresponds with previous studies [15, 17, 18, 30] . previous ehealth studies have also demonstrated that older, unmarried, less educated, and lower-income patients use health applications for self-management less frequently than their younger counterparts [30] . unfortunately, we did not have sufficient data on education level and social-economic status in-hospital complications, a n (%) 19 ( in our population. however, data on social status, housing, and referral to snfs suggests that non-participants had less social support. also, the two patients who were residing in a snf both refused participation. we believe that improving social support would decrease both technological barriers and refusal rates due to a perceived high mental burden. the acceptance and implementation of new digital technologies has been accelerated by the covid-19 pandemic, as remote consultation and monitoring decrease the risk of spreading the virus [9] . these changes will lead to a more prominent and perhaps permanent role for telemedicine in future health care and underline the urgency of improving digital technology skills in specific populations such as older adults [9] . because learning new digital skills takes time and energy [27] , it is best to empower older adults to do so when they are relatively healthy and not when they have just been diagnosed with cancer or scheduled for surgery. furthermore, it is essential that people who have insufficient social support can rely on professional or peer support provided by, for example, older adult advocacy groups or the government [31] . a limitation of this study is that we did not have information on the patients' socio-economic status, educational level, geriatric assessment, or impact of complications on functional recovery and quality of life. this is inherent to the retrospective analysis of a prospective cohort study. approximately one fifth of all patients experienced a serious complication within 30 days after hospital discharge, and hospital readmission rates were 15% for participants and 23% for non-participants. because we retrospectively collected data regarding non-participants from hospital medical records, complications and readmissions outside our hospital might have been missed; on the other hand, for participants, data on complications and readmissions were complemented with self-reported data at three months follow-up. in addition, participation in the telemonitoring study might have led to identification of more complications. nonetheless, these results demonstrate a high incidence of postoperative complications post-discharge for all patients. more referrals to snfs among non-participants also suggest that complications have a larger impact on this group. additional parameters to measure the impact of complications, such as functional recovery, quality of life and long-term survival, are needed in future research. subsequent telemonitoring studies with older adults should consider various logistical problems in usability and acceptability [19] . when considering the technological and mental barriers described in this study, studies could be even more inclusive. for example, wifi hotspots could be provided at home for the patients without internet access at home. a technical 'buddy' could be assigned or technological support materials developed to decrease the fear of new technologies and enrol patients with digital illiteracy. the main barriers to older adults' participation in a perioperative telemonitoring study were lack of internet access at home, digital illiteracy, and a perceived high mental burden. non-participants were older and more often female, had a higher asa classification and more polypharmacy, and more often lived alone without a partner compared with participants. the complication rate was high in both participants and non-participants, with a seemingly greater impact of those complications in non-participants. this demonstrates the need for inclusion of underrepresented patients, who are at a high risk for severe postoperative complications and who experience a large impact of these complications. we should be aware of the barriers to participation of this population in order to avoid further dividing patients with low and high digital health literacy. solutions to improve this situation are needed on a societal level and include improving internet accessibility, teaching digital skills and expanding social support for older people. the prospective telemonitoring study was funded by european union's horizon 2020 research & innovation program (project grant agreement number 689802, connecare). the funding source had no role in study design; in the collection, analysis, and interpretation of data; in the writing of the report; nor in the decision to submit the paper for publication. ltj: no conflicts of interest to declare; mmh: no conflicts of interest to declare; sf: no conflicts of interest to declare; mhmo: no conflicts of interest to declare; ghdb: no conflicts of interest to declare; blvl: no conflicts of interest to declare. global cancer incidence in older adults, 2012 and 2035: a population-based study global cancer surgery: delivering safe, affordable, and timely cancer surgery frailty and post-operative outcomes in older surgical patients: a systematic review assessment for frailty is useful for 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indicator in home-dwelling and institutionalized elderly people studies of illness in the aged the index of adl: a standardized measure of biological and psychosocial function the clavien-dindo classification of surgical complications: five-year experience internet acces at home in the netherlands technology fear stops older adults from logging on: but scientists are breaking the computer block older adults talk technology: technology usage and attitudes social support and "playing around": an examination of how older adults acquire digital literacy with tablet computers acceptance and use of ehealth/mhealth applications for self-management among cancer survivors attitudes towards and limitations to ict use in assisted and independent living communities: findings from a specially-designed technological intervention we wish to express our gratitude to all colleagues in the connecare consortium for providing input during the development and supporting of the it systems and connected devices used in the prospective telemonitoring study. key: cord-332108-6riu44fw authors: alanezi, fahad; aljahdali, anan; alyousef, seham; alrashed, hebah; alshaikh, wyam; mushcab, hayat; alanzi, turki title: implications of public understanding of covid-19 in saudi arabia for fostering effective communication through awareness framework date: 2020-09-18 journal: front public health doi: 10.3389/fpubh.2020.00494 sha: doc_id: 332108 cord_uid: 6riu44fw background: participation of the public is an important and most effective approach for controlling the spread of novel coronavirus. however, considering its novel nature, it is important to create awareness among the public to be able to take timely preventive measures. on the contrary, misinformation and myths from online communities result in severe damages in mitigation of this novel disease. objective: focusing on these aspects, this manuscript reviews public awareness about covid-19, myths surrounding it, its symptoms, treatment, transmission, importance of information sources, types of information to be considered in awareness campaigns, promotional channels, and their implications in saudi arabia. methods: an online questionnaire-based survey was used for collecting data related to five major aspects related to covid-19 and awareness creation process. the survey was accessed by 1,881 people, out of whom 741 people participated in the survey. however, 150 dropouts left the survey in between, as a result of which a final sample of 591 was achieved, indicating the response rate of 39.3% and a completion rate of 79.76%. results: awareness levels of the participants related to covid-19, its means of transmission, preventive measures, symptoms, and treatment were identified to be moderate to high (60–80%). however, reliance on a few myths and violation of certain preventive measures were identified with majority of the participants (more than 60%). the ministry of health was identified to be the most reliable source of information followed by family and friends. moreover, 15 types of information were identified to be highly relevant and important, which need to be effectively disseminated among the public through effective communication channels. conclusions: lack of awareness can result in serious outcomes in relation to covid-19. effective awareness campaigns including relevant information from reliable sources can improve the knowledge of people, and they must be effective in developing positive attitudes among the public toward adopting preventive measures. creating public awareness about infectious diseases which are caused by new pathogens is one of the effective approaches for controlling the spread of diseases such as covid19 . as the information about the disease, its symptoms, precautionary methods, diagnosis, and treatment may vary with other infectious diseases and it may take considerable amount of time, it is important for timely updates about the pandemic and the preventive care to be disseminated among the public in order to contain the transmission of infection. lack of public awareness about covid-19 was observed in different places in the initial days of the pandemic, and people roamed freely without following precautionary methods such as social distancing, and wearing masks (1) (2) (3) . while the nature of the pandemic changes, it is important that the information and advice remain constant. therefore, it is very important that accurate and reliable information must be disseminated to the public through verified sources, and spread of any misinformation must be effectively contained to prevent any loss. therefore, various reliable sources including the world health organization (who) and united nations sister organizations, along with governments of various countries, have been providing regular updates and the necessary information to prevent covid-19 through various channels (4) (5) (6) . another important factor of creating awareness is to prevent the spread of myths and misinformation. it is evident that perceptions and myths such as drinking raw alcohol can cure covid-19 by people in iran (7) , that 5g towers are the cause for covid-19 by people in the uk (8) , and eating garlic or mint can cure covid-19, as well as many others (9) , can lead to serious damage and may increase the chances of contamination. a recent study has identified that there is a positive correlation between the increase in the number of covid-19 cases and the relative search volumes of terms related to covid-19 (10) . in addition, public awareness about covid-19 varied across sub-regions in different countries, and the immediate need for strengthening the publicity regarding covid-19 by the governments was identified. however, the concerns about the transmission and the number of infected persons is growing at alarming rates in the past few months compared to other diseases like sars, mers-cov, and influenza. a recent review (11) of various studies in china and other countries related to covid-19 has indicated that the reproductive rate (it is an indication of the transmissibility of a virus, representing the average number of new infections generated by an infectious person in a totally naive population) of covid-19 is very high compared to other infectious diseases. in addition, children and old-aged people are identified to be at high risk of contamination with the novel coronavirus if necessary precautionary methods were not taken. studies have identified that infection was mainly identified in family clusters and workplaces (12) , reflecting the transmission by direct or close contact in the environment of those with infection. on the other hand, the governments are adopting various approaches (12) such as containment and mitigation activities to delay the major surges in number of patients and level the demand for healthcare resources such as hospital beds, testing kits, medicines, and other medical equipment and also to protect the most vulnerable from infection, including elderly people and those with health complexities or other critical diseases (13, 14) . considering these approaches by the governments, it is important that people are provided with accurate and timely information in relation to these approaches. focusing on the aspect of public awareness, this paper investigates the level of public awareness in saudi arabia and analyzes the types of information to be communicated from the reliable sources and its implications on the public by proposing a conceptual framework. the purpose of this study was to investigate the level of public awareness about covid-19 in saudi arabia and the importance of information sources, information types, and communication/promotional channels for creating awareness among the people in saudi arabia. as an approach for achieving this objective, an online questionnaire-based survey was adopted. the questionnaire was designed with various aspects related to covid-19 and level of awareness. it included various sections, including questions related to general awareness of covid-19 (four items), its symptoms (six items), transmission (three items), preventive care (10 items), treatment options (two items), myths (eight items), types of information (15 items), communication/promotional channels (nine items), and sources of information (five items). multiple-choice answers and fivepoint likert scale ratings (15) were used by the participants to answer the questions. the questionnaire was initially designed in english and was then translated to arabic by two professional arabic translators. the arabic version of the questionnaire was designed using questionpro application. a pilot study was conducted with 12 randomly selected people for evaluating the questionnaire. based on the feedback from the pilot study participants, few changes were made in relation to the questions' formulation and grammatical errors in arabic. in addition, cronbach's alpha for all items in the questionnaire was identified to be >0.88, revealing good consistency and reliability. the general public living in saudi arabia were recruited for the survey using the survey link generated using questionpro application. the survey link was initially forwarded to the general public by posting the link on community groups and other platforms on social media platforms. moreover, the survey was conducted for a period of 4 weeks from 23 march to 19 april 2020. considering the purpose and objective of the study, which was to collect the data from the general population of saudi arabia, the participants were randomly selected. however, the targeted sample population was composed of adults aged 18 years or above. as an approach to reach maximum samples in a short time, snowball sampling technique (16) was adopted, in which a request is made while forwarding the survey link, whereby participants were requested to forward the message to their friends and colleagues. accordingly, the survey link was initially forwarded to 439 people through various modes. as a result of using snowball sampling technique, the link was accessed by 1,881 people, out of which 741 people participated in the survey. however, 150 dropouts were identified who left the survey in between; as a result a final sample of 591 was achieved, indicating a response rate of 39.3% and a completion rate of 79.76%. in addition, the average time taken by the participants to complete the survey was 7 min. the survey was developed using questionpro application and conducted for a period of 4 weeks. the data were analyzed and discussed using four themes, which included sources of information, types of information, communication/promotional channels, and implications of good public awareness. relative frequencies for each item under these themes are used for analyzing the data, which are presented in the following section. the final sample achieved in this study was 591. the demographic information of the participants is presented in table 1 . among the total participants, 65.31% were male and 34.69% were female. considering the age groups, 59.05% were aged between 25 and 34 years followed by 16.07% between 45 and 54 years, 13.36% between 35 and 44 years, 9.47% between 18 and 24 years, and only 12 participants aged more than 54 years. focusing on the education levels of the participants, 57.39% have bachelor's degrees, followed by 14.25% who have master's degrees, 12.89% have diploma, 11.13% have ph.d., and 21 participants have secondary education. focusing on the professions of the participants, a diverse scenario can be observed with 20.81% government employees, 19.79% private sector employees, 26.90% business professionals, 10.65% students, 14.45% unemployed, and 7.27% retired individuals. majority of the participants belonged to three regions: 33.52% from medina, 28.73% from riyadh, 18.33% from mecca, and 19.42% belonged to other regions of saudi arabia. it is important to note that 85.78% of the participants' educational background (degree education) was not related to healthcare and 84.44% of the participants were not working in healthcarerelated organizations. working in healthcare organizations or having a qualification related to healthcare may increase the possibility that the participants were more aware of the infectious diseases/healthcare aspects compared to other participants. focusing on the general awareness of covid-19, majority of the participants, 86.31%, identified incubation period (the time between catching the virus and beginning to have symptoms of the disease) to be ranging from 5 to 14 days, while 12.68% of the participants stated they do not know, and six participants stated 21 days. in addition, 83.6% of participants were aware that covid-19 is a disease caused by novel coronavirus, and 91.5% of participants believed it was identified in wuhan region, china. while 36.25% of other regions 115 is your education background related to healthcare practices/healthcare management? no 507 are you working in any healthcare related organization? no 499 participants believed that the source of the novel coronavirus is "bats, " 14.35% believed the source is "chinese man;" 49.4% stated that the source is not yet identified. in addition, there are various myths being circulated online, and the participants' awareness levels in relation to these myths are presented in table 2 . the findings reflected that 18% of the participants believed various myths circulating online, which are not officially confirmed or declared by the governments or healthcare organizations. public awareness about covid-19 symptoms is presented in table 3 , which has revealed that majority of the participants (84.26%) identified fever, dry cough, and breathing difficulties as the general symptoms of covid-19, and prolonged illness or symptoms in severe cases as identified by 86.63% of the participants may include pneumonia, acute respiratory syndrome, and organ failure. similarly, public awareness about the transmission risks is presented in table 4 . majority of the participants (76.48%) identified different possibilities of transmission by not adopting social distancing measures. in relation to the possibility of cure and treatment, it was acknowledged by 83.65% of the participants that most of the affected persons may recover on their own, and only a small proportion of patients who have severe pre-medical conditions, are old-aged, and are children may need intensive care. it is interesting to note that 74.79% of the participants were aware that people with chronic acute respiratory disease can be severely affected if they are infected with novel coronavirus. in addition, 69.43% of the participants were aware that there is no treatment available for covid-19, but about 30% believed that there is a treatment available, which may be an issue of concern, as they may not seriously adopt preventive measures. focusing on the public awareness of preventive measures, table 5 indicated good awareness levels, as 70-99% of participants acknowledged different preventive measures. however, only 78.85% of the participants stated that they always followed precautionary methods, while 12.96% stated they followed sometimes, and 8.19% stated that they did not follow any precautionary methods. however, 97.6% of the participants believed that quarantine and staying at home is an effective approach toward preventing the spread of novel coronavirus. in addition, only 32.29% of the participants stated that they did not leave home during lockdown/curfew, while 54.2% stated they left home as it was necessary, and 13.51% stated that they left home without any reason. accordingly, 30.64% stated they left home once (1 day) a week, 12.03% 2 days per week, 6.75% 3 days per week, 3.95% 4 days per week, 1.98% 5 days per week, and 2.80% 6 days per week; 32.62% stated they did not leave the house. in relation to the reliable sources of information, participants were asked about various sources which they would prefer, and the results are presented in table 6 , which indicates that majority of the participants relied on the ministry of health, friends, and family. in addition, the participants were asked to rate the importance and effectiveness of various types of information which need to be promoted, and the findings are presented in table 7 . although all types of information were important, few types such as access to care, helpline and support, health insurance, and access to medicine were highly important. similarly, participants were asked to rate the importance and effectiveness of various channels/modes of communication, and the responses are presented in table 8 , which indicated online government portals and mobile [calls/sms (short message service)] were identified to be important. the findings related to public awareness have revealed some important aspects related to the information known by the public and the implications especially in adopting preventive measures. in addition, the information flow, reliable sources, types of information, and modes of promotions can be assessed in the context of saudi arabian lifestyle. firstly, focusing on the general awareness about covid-19, participants exhibited good understanding about the disease, the pathogen causing the disease, its sources, and the incubation period. though the source of covid-19 is yet to be identified, there are a considerable number of participants who believed the source of the virus might be bats or transmitted through chinese people. in relation to the awareness about myths circulating online and the truth in them, most of the participants reflected good understanding of the myths, which were verified by the world health organization (9) and turned out to be false. however, in relation to few myths, there are a considerable number of participants (∼30% of the participants) who believed them to be true, such as using alcohol, hand dryers, and eating garlic can kill the virus. these can have serious outcomes, as it is evident from the recent incidents such as drinking raw alcohol in iran (7) and burning down 5g towers in the uk (8) . therefore, the spread of such myths must be targeted by effectively promoting awareness campaigns through various channels. focusing on the symptoms, participants reflected good understanding, as they stated fever, dry cough, and breathing difficulties as general symptoms which were identified by various reliable organizations (17) (18) (19) . one of the important aspects of covid-19 awareness is related to the various means of transmission from an infected person. in relation to these factors, most of the participants reflected good understanding, as they identified that the main cause of virus spread is through the droplets released by an infected person through sneezing or coughing, which can rest on different places for a considerable amount of time. however, one of the concerns is that about 24% of the participants were not aware of these factors. unlike other infections, the importance of awareness and preventive measures is very important in containing the spread of covid-19, as there is a high risk of contamination from a single person which can easily lead to the infections across the community or region if proper precautionary methods are not implemented (20, 21) . focusing on awareness of preventive measures, participants exhibited good understanding, especially in relation to social distancing, covering mouth and nose while coughing or sneezing, avoiding close contact with symptomatic (flu, cough) persons, and seeking medical help in case the symptoms prolong after incubation period during quarantine. however, other preventive measures such as washing hands regularly and using hand sanitizers were only recognized by ∼75% of the participants. these two approaches are among the important measures which need to be considered on a daily basis to prevent being infected and contain the spread of the virus (22) . in relation to the reliable sources of information about covid-19, majority of the participants relied more on the saudi ministry of health, friends, and relatives than on the recognized bodies such as who and healthcare experts. it is important that the public should rely on reliable sources of information, as unreliable sources increase the chances of contamination and other challenges related to healthcare and social challenges as a result of vast misinformation available on various channels (23, 24) . in relation to the types of information to be considered during covid-19 outbreak, there has been no consensus among the organizations. however, information related to preventive measures, symptoms, and self-care were the most promoted (10, (25) (26) (27) ; there is a need for considering the additional information in order to prevent the spread of mis-information, enable people to manage their activities during lockdown/quarantine, and manage their lifestyles and other aspects such as finance, basic needs, and other necessary aspects. therefore, various types of information were reviewed, and 15 different types of information (presented in table 7 ) were perceived to be highly important by most of the participants. focusing on the channels/modes of promotion, it is essential to consider that information must be disseminated to a large section of the population within a short time, and it is also essential that regular updates can be easily accessed by the public. social media and mobile phones (sms/calls) can be effective in reaching a large section of the population in a short time. therefore, approaches such as passing messages and information about covid-19 before connecting a call on mobiles by the mobile services companies and daily sms and mobile applications launched by the government to create awareness and track diseases and vulnerability of the users having an infection are proving to be effective in different regions (28) (29) (30) (31) (32) . however, majority of the participants preferred online government portals and press releases compared to social media platforms. in addition, mobiles and television were considered by the participants to be effective platforms for creating awareness. it is interesting to note that newspapers were least preferred compared to other channels, as the risk of contamination may be high. by effectively creating public awareness, the spread of covid-19 can be minimized, and the risk of infections, death, and losses can be prevented. it can also result in effective health outcomes, improve quality of life during lockdowns, survival, and proper planning of work, business and finances, etc. based on these findings, a framework (figure 1) for creating public awareness with components including information sources, types of information, communication channels, and the outcomes is formulated especially considering saudi arabian lifestyle. this framework can also be used as conceptual framework for future studies focusing on evaluating public awareness related to pandemics/infectious diseases. there are a few limitations in this study. the first is the methodological approach based on survey questionnaire for collecting and analyzing the public awareness data related to covid-19; a mixed method approach such as observations and interviews could have gathered more qualitative and behavioral data which can be used to analyze the public reactions and lifestyle changes in relation to covid-19 outbreak. in addition, the survey was conducted over a period of 4 weeks, which could have been increased to achieve a large sample population and response rates. a major limitation of this study is the online questionnaire due to the lockdown situation that reduced the reachability to boarder communities with good sample pool. various implications can be drawn from the study. firstly, this study contributes to the literature by providing the relationship between awareness and self-care practices adopted by the public considering the covid-19 outbreak, reflecting the people's attitudes toward the pandemic and preventive measures. the findings from the survey can prove to be a valuable source of information for the government, based on which it can update its awareness creation strategies and also tract peoples' attitudes toward the pandemic. in addition, the proposed framework can also be used as a conceptual framework in other research studies focusing on public awareness about pandemic/infectious diseases. this study analyzed the public awareness about covid-19, its precautionary measures, and its implications on the lifestyles of the people in saudi arabia. an online survey was conducted, considering the prevailing situation of lockdown to reach maximum participants. a total of 591 respondents participated in this survey. overall, the findings revealed that public awareness about covid-19 in saudi arabia varied between moderate to high, and its implications reflected that a few measures were not adopted by the public, such as staying at home, which resulted in increased number of positive cases. though they were aware of the precautionary measures of staying at home during lockdowns, most of the participants frequently went out of their homes, which might increase the risk of contamination. therefore, it is very much essential that strict measures and an effective approach for creating awareness are to be adopted, to ensure the success of the lockdown strategy in order to limit the spread of covid-19. the original contributions presented in the study are included in the article/supplementary material, further inquiries can be directed to the corresponding author/s. how brazilian favela journalists are raising awareness about covid-19. open democracy covid-19 awareness among healthcare students and professionals in mumbai metropolitan region: a 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and that is annoying. india today available online at the studies involving human participants were reviewed and approved by the institutional review board of the imam abdulrahman bin faisal university. the patients/participants provided their written informed consent to participate in this study. all authors listed have made a substantial, direct and intellectual contribution to the work, and approved it for publication. key: cord-289763-jek2pd31 authors: fisher, kimberly a.; bloomstone, sarah j.; walder, jeremy; crawford, sybil; fouayzi, hassan; mazor, kathleen m. title: attitudes toward a potential sars-cov-2 vaccine: a survey of u.s. adults date: 2020-09-04 journal: ann intern med doi: 10.7326/m20-3569 sha: doc_id: 289763 cord_uid: jek2pd31 background: coronavirus disease 2019 (covid-19) has rapidly instigated a global pandemic. vaccine development is proceeding at an unprecedented pace. once available, it will be important to maximize vaccine uptake and coverage. objective: to assess intent to be vaccinated against covid-19 among a representative sample of adults in the united states and identify predictors of and reasons for vaccine hesitancy. design: cross-sectional survey, fielded from 16 through 20 april 2020. setting: representative sample of adults residing in the united states. participants: approximately 1000 adults drawn from the amerispeak probability-based research panel, covering approximately 97% of the u.s. household population. measurements: intent to be vaccinated against covid-19 was measured with the question, “when a vaccine for the coronavirus becomes available, will you get vaccinated?” response options were “yes,” “no,” and “not sure.” participants who responded “no” or “not sure” were asked to provide a reason. results: a total of 991 amerispeak panel members responded. overall, 57.6% of participants (n = 571) intended to be vaccinated, 31.6% (n = 313) were not sure, and 10.8% (n = 107) did not intend to be vaccinated. factors independently associated with vaccine hesitancy (a response of “no” or “not sure”) included younger age, black race, lower educational attainment, and not having received the influenza vaccine in the prior year. reasons for vaccine hesitancy included vaccine-specific concerns, a need for more information, antivaccine attitudes or beliefs, and a lack of trust. limitations: participants' intent to be vaccinated was explored before a vaccine was available and when the pandemic was affecting a narrower swath of the united states. questions about specific information or factors that might increase vaccination acceptance were not included. the survey response rate was 16.1%. conclusion: this national survey, conducted during the coronavirus pandemic, revealed that approximately 3 in 10 adults were not sure they would accept vaccination and 1 in 10 did not intend to be vaccinated against covid-19. targeted and multipronged efforts will be needed to increase acceptance of a covid-19 vaccine when one becomes available. primary funding source: agency for healthcare research and quality. c oronavirus disease 2019 is caused by the ␤-coronavirus severe acute respiratory syndrome coronavirus 2 (sars-cov-2). this virus has rapidly become a major global threat, instigating a pandemic affecting more than 185 countries and 3 500 000 people and leading to nearly 250 000 deaths worldwide (1) . the pandemic has overwhelmed hospital systems, undermined economic activity worldwide, and instilled fear into the general populace (2, 3) . an international poll conducted in april 2020 found that 61% of those surveyed identified covid-19 as the most concerning national issue, overtaking unemployment, health care, and poverty (4) . in a separate survey conducted at the same time in the united states, more than 80% of participants were very or somewhat concerned about being infected with coronavirus (5) . in response to the massive global effects of covid-19, multiple laboratories worldwide are working to create an effective vaccine. the possibility that one will be available in 12 to 18 months is seen by many as the most promising means of controlling the covid-19 pandemic. over the past century, vaccinations have become a routine and effective preventive measure in reducing the rate of and eradicating or nearly eradicating certain viral illnesses (6) . besides providing direct immunity and preventing disease among vaccinated individuals, vaccines have been shown to reduce infections even among individuals who are not vaccinated, through herd immunity, if a sufficient proportion of the population is immune (7) . many pharmaceutical companies and research labs are currently working with messenger rna, dna, subunit, virus-like particles, and viral vectors to discover an effective vaccine for the covid-19 pandemic (8, 9) . on an unprecedented timeline, multiple vaccines have been developed and are currently being tested in large-scale phase 3 trials (10) , suggesting that a vaccine may be available in the foreseeable future. the great potential of a vaccine against covid-19 is tempered by rising vaccine skepticism in the united states and worldwide, which may present challenges to widespread vaccine uptake when a vaccine becomes available (11) (12) (13) (14) . it is unknown whether the unprecedented and severe effects of covid-19 in the united states will overcome vaccine skepticism and foster widespread acceptance of and demand for vaccination. we assessed intent to be vaccinated for the novel coronavirus with the question, "when a vaccine for the coronavirus becomes available, will you get vaccinated?" followed by the response options "yes," "no," and "not sure." participants who responded "no" or "not sure" were asked one of the following open-ended questions, respectively: "what makes you unwilling to get the vaccine?" or "what makes you unsure whether you will get the vaccine?." to assess perceived risks of infection, we asked, "what is your best guess as to whether you will get the coronavirus within the next 6 months?"; response options were "i don't think i will get the coronavirus," "i think i will get a mild case of the coronavirus," "i think i will get seriously ill from the coronavirus," or "i have already had the coronavirus." survey items are shown in appendix table 1 (available at annals.org). we conducted 2 rounds of pilot testing of the main question assessing intent to be vaccinated among a convenience sample of over 100 individuals and did not detect any problems. data on participant characteristics were provided by norc and included age, sex, race/ethnicity, educational attainment, household income, household size, marital status, employment status, geographic location, urban or rural location (addresses within a metropolitan statistical area were categorized as urban), receipt of influenza vaccination in the prior year, and self-rated overall health status. norc collects data on healthrelated variables (such as receipt of influenza vaccination and self-rated overall health status) upon enrollment or soon after for most panel members; if a panel member has not responded to a specific item, that item may be included on subsequent surveys. all data provided to the investigators were fully deidentified. participant characteristics were summarized by using frequencies and percentages. we used crosstabulations and 2 tests to estimate unadjusted associations of participant characteristics and perceived personal risk for coronavirus with the 3-category outcome intent to get vaccinated. to better distinguish characteristics associated with responses of "not sure" versus "yes" and characteristics associated with responses of "no" versus "yes," we also calculated separate 2 tests and associated p values for these 2 sets of comparisons. to estimate corresponding adjusted (multivariate) associations, we used multinomial logistic regression, an extension of binomial logistic regression that compares each of 2 or more nonordered outcome categories to the reference category. in particular, we modeled both natural log [pr (not sure)/pr (yes)] and natural log [pr (no)/pr (yes)] as a function of participant characteristics. this approach allows different associations with covariates for the 2 comparisons while providing overall p values for covariates. whereas coefficients from a binomial logistic regression model are typically exponentiated to obtain odds ratios, exponentiated coefficients from a multinomial logistic regression model are interpreted as relative risk ratios (rrrs). an illustrative calculation is provided in the footnote to table 3 . characteristics that were not statistically significant (p < 0.05) in the multivariate multinomial modeling were omitted in the final model; these characteristics were found to be correlated with predictors retained in the final model (for example, household income was related to education). we considered the possibility that inclusion of prior receipt of influenza vaccine in the model may obscure other predictors of covid-19 vaccine hesitancy owing to overlap in the reasons for reluctance to get an influenza or covid-19 vaccine. we therefore repeated the primary analysis after removing receipt of influenza vaccine from the model. adjusted percentages were calculated for each predictor category by fixing all other predictors at their observed disattitudes toward a potential sars cov-2 vaccine among u.s. adults tributions. to assess model performance, we calculated c-statistics and hosmer-lemeshow statistics separately for binomial logistic regressions for "not sure" versus "yes" and "no" versus "yes." all analyses incorporated survey sampling weights based on gender, age, education, race/ethnicity, and region. analyses were conducted by using sas, version 9.4. we used thematic analysis to inductively generate codes and identify themes in the responses to the open-ended query soliciting reasons for vaccine hesitancy (15) . the coding team included investigators with backgrounds in health communication, health literacy, patient-provider communication, clinical medicine, and clinical social work; all coding team members had prior experience in qualitative analysis. a coding framework was created on the basis of initial review of all responses. codes and associated definitions were revised and refined through iterative application and discussion. two analysts (k.f., s.b.) then independently coded all responses. more than 1 code could be assigned to a response if applicable. coding discrepancies were discussed until agreement was reached; the third member of the coding team was available to adjudicate but was not needed. codes were assigned in excel; final codes were merged into spss, version 25, to facilitate data manipulation and summarization. our study was determined to be exempt by the university of massachusetts medical school institutional review board. dr. fisher is supported by agency for healthcare research and quality grant k08hs024596. the funder had no role in the design, conduct, or analysis of this study. the amerispeak omnibus survey was released to 6247 panel members, and a total of 1003 (16.1%) responded. most participants (91.2%) completed the survey via the web; the remainder (8.8%) completed it via telephone interview. twelve participants did not respond to the question on intent to be vaccinated; all results presented here are based on the 991 participants who responded to this question. a majority of participants (63.3%) were white, approximately one third (30.0%) were 60 years of age or older, and 51.5% were female. participants had varied levels of educational attainment, with more than one third (37.8%) having a high-school diploma or less. most participants perceived their risk for coronavirus to be low, predicting that they will either not get the coronavirus (64.1%) or that they will get a mild case of the coronavirus (27.1%) in the next 6 months. only 58 participants (6.0%) predicted they will get seriously ill from the coronavirus. approximately one half (52.8%) of participants reported having received the influenza vaccine previously. additional participant characteristics are shown in table 1 . overall, 57.6% of participants (n = 571) intended to be vaccinated, 31.6% (n = 313) were not sure whether they would be vaccinated, and 10.8% (n = 107) did not intend to be vaccinated. participant characteristics associated with a higher chance of responding "no" or "not sure" versus "yes" were being younger (<60 years), female, or black or hispanic; having lower educational attainment, lower household income, or larger household size, and being less likely to report having received an influenza vaccine. in addition to these differences, participants who responded "not sure" were more likely to live in the south or west and to believe they were at less personal risk for coronavirus despite providing lower ratings of their overall health. participants who responded "no" were more likely to live in a rural setting ( table 2) . after adjustment for differences in participant characteristics ( table 3) , factors that were independently associated with vaccine hesitancy (response of "no" or "not sure") include younger age (<60 years), black race, educational attainment of less than a college degree, and not receiving an influenza vaccine in the prior year. participants who did not have a high school diploma had a nearly 8-fold higher relative likelihood of responding "no" versus "yes" compared with those who had a college degree or higher (rrr, 7.8 [95% ci, 3.1 to 19.6]). black race was associated with a more than 6-fold higher chance (rrr, 6.4 [ci, 3.2 to 13.0]) of not intending to be vaccinated versus intending to be vaccinated compared with white race. participants who had previously received an influenza vaccine had a 94% lower relative likelihood of responding "no" versus "yes" (rrr, 0.06 [ci, 0.03 to 0.11]) compared with those who had not received an influenza vaccine. other characteristics, such as female sex, some age strata, hispanic ethnicity, and perceived personal risk for coronavirus, were associated with vaccination intent but did not consistently achieve statistical significance for both response categories ("not sure" and "no"). living in a rural area was strongly associated with responding "no" when asked about intent to be vaccinated, but not with responding "not sure." household income, household size, region, and self-reported health were not significantly associated with vaccination intent after adjustment for the characteristics in table 3 . results including these as model predictors were similar (data not shown). removal of prior receipt of influenza vaccine from the multinomial model resulted in an increase in the relative risk ratios comparing "no" versus "yes" for 2 age groups (18 to 29 years and 45 to 59 years), such that the ci no longer included 1 while other results remained similar (appendix table 2 , available at annals .org). because one of the main goals of our study was to predict who may be hesitant to be vaccinated against covid-19 and prior receipt of influenza vaccine offers a pragmatic way to identify these individuals, we report the findings from the model that included prior receipt of influenza vaccine. hosmer-lemeshow statistics for "not sure" versus "yes" and for "no" versus "yes" were not statistically significant (p = 0.37 and 0.50, respectively), and corresponding c-statistics were 0.74 and 0.89, indicating excellent model fit and performance. of the 420 participants who were unsure or did not intend to be vaccinated, 303 (72.1%) provided a reason for their response and constitute the sample for the qualitative analysis. the 118 remaining participants who answered "not sure" or "no" (28.1%) did not provide a reason for their hesitancy (for example, they did not respond, responded simply "don't know," or provided an uninterpretable response). participants' reasons for being unsure or not intending to be vaccinated are broadly categorized as having specific concerns about the vaccine; needing additional information; holding antivaccine attitudes, beliefs, or emotions; and not trusting entities involved in vaccine development, testing, or dissemination ( table 4 ). the most common reasons cited by participants who were not sure whether they will be vaccinated included specific concerns about the vaccine (such as safety or effectiveness) or a need for more information. in contrast, the most common reasons provided by participants who did not intend to be vaccinated included antivaccine attitudes, beliefs, or emotions, and lack of trust. illustrative quotes are provided in appendix table 3 (available at annals .org). in this large, nationally representative sample, nearly one half (42.4%) of participants indicated hesitancy to be vaccinated against covid-19 when a vaccine becomes available. this finding is especially striking considering that the survey was conducted during mid-april 2020, when the number of deaths per day due to covid-19 were at or near peak levels of the initial surge in the united states (16). the percentage of individuals who intend to be vaccinated (57%) is only slightly higher than the percentage of adults who received the influenza vaccination (45%) during the 2018 -2019 influenza season (17); this is surprising, attitudes toward a potential sars cov-2 vaccine among u.s. adults given the increased severity, death rate, societal disruption, and resultant media coverage associated with the covid-19 pandemic. increasing vaccination rates are expected to confer substantial benefits, including reductions in covid-19related hospitalizations, strain on hospital capacity, and deaths. for example, it has been estimated that increasing influenza vaccination coverage by 5 percentage points could have prevented 4000 to 11 000 hospitalizations in the 2017-2018 influenza season (18) . the increased severity of covid-19 compared with influenza suggests that the magnitude of benefit of increased coronavirus vaccination coverage could be even greater. the percentage of individuals who will need to be vaccinated to achieve herd protection is not yet defined for covid-19 because it depends on vaccine effectiveness, patterns of population mixing, vaccination patterns, and the basic reproduction number (r 0 ) (7) of the novel coronavirus. using a pooled estimate of the r 0 of 3.32 (19) and assuming a best-case scenario in which a vaccine has perfect effectiveness yields a projection that at least 70% of the population will need to be vaccinated to achieve herd protection. in fact, a newly developed coronavirus vaccine is unlikely to be perfectly effective, so the coverage required to achieve herd immunity will almost certainly be higher than 70%. considering that intent as assessed in our study does not account for incomplete followthrough and barriers to vaccine access, it is likely that a substantial gap will exist in the number needed to be vac attitudes toward a potential sars cov-2 vaccine among u.s. adults cinated to achieve herd protection and the number who receive vaccination. concerted efforts will be needed to persuade the large percentage of individuals who are unsure about or opposed to being vaccinated against covid-19 if we are to realize the substantial benefits afforded by high immunization coverage rates. we found several independent predictors of being hesitant to be vaccinated against covid-19; the strongest were lower educational attainment, black race, not having had a recent influenza vaccination, and perceived personal risk for coronavirus, consistent with the findings of a national survey conducted by rti (20) . evidence that these characteristics are predictive of vaccine hesitancy could be useful in targeting vaccine messaging and outreach to populations at risk for not being vaccinated. our findings highlight the importance of social determinants of health, such as educational status (a close proxy for health literacy [21] ) and race/ethnicity, and their influence on preventive health behaviors (22) . racial disparities in vaccination rates have been described for other vaccinations. for example, rates of influenza vaccination among african american persons (39.4%) and hispanic persons (37.1%) were substantially lower than among white persons (48.7) during 2018 -2019 (17). these differences are particularly concerning given the disproportionately high toll of covid-19 among african american communities (23-26). the confluence of increased covid-19 disease burden and potential for decreased receipt of vaccination has the potential to substantially magnify health-related disparities experienced by african american persons. our findings highlight the need for vaccine implementation strategies that anticipate racial gaps in covid-19 vaccination. these strategies could draw on the approaches used to successfully close racial disparities in measles vaccination while being mindful of persistently lower rates of influenza vaccination rates among minority adults stemming from lack of trust in health care (27) . prior research has demonstrated the importance of social norms and perceived disease risk in influencing vaccination decisions among african american persons and could be explored as a means of fostering coronavirus vaccine acceptance among this population (28, 29) . the association between intent to be vaccinated and perceived risk for coronavirus suggests this may be a particularly important lever for promoting vaccination. in addition to being targeted for populations least likely to be vaccinated, such as members of racial and attitudes toward a potential sars cov-2 vaccine among u.s. adults annals.org annals of internal medicine ethnic minority groups and individuals of low health literacy, successful vaccination campaigns will need to leverage an understanding of why individuals may be hesitant to be vaccinated in order to tailor messaging to mitigate these concerns. concern about vaccine safety was one of the most commonly cited reasons for being unsure about accepting vaccination in the present study, consistent with studies of other vaccines (30). a reuters poll found that approximately 75% of americans would agree to be vaccinated against covid-19 if they received assurances about the safety of the vaccine (31). collectively, these findings suggest that transparent reporting of vaccine safety in a way that people of all educational levels can understand is likely to be an effective strategy to increase public uptake of vaccination. however, many participants in our study and the reuters poll indicated hesitancy to be among the first to be vaccinated, which will probably delay achievement of high vaccination coverage rates for covid-19. over one half (56.6%) of respondents who provided a reason for not intending to be vaccinated referred to antivaccine attitudes, beliefs, or emotions. of these, many indicated only that they did not like, want, or believe in vaccines, whereas others made explicit reference to scientifically inaccurate information, such as the association between vaccines and autism and that it is not possible to vaccinate against a virus. these beliefs and essentially emotional responses to vaccination are likely to be among the hardest to overcome, because information alone is unlikely to have an effect. it may be that messages designed to engage and influence emotions, such as narratives or stories, will be more effective than expository or informational health messages (32). lack of trust was the second most common reason for responding "no" to intent to be vaccinated. trust has been shown to be a determinant of vaccine uptake (33), suggesting this finding is likely to be of consequence and indicating a need for strategies aimed at increasing trust among individuals with greater degrees of vaccine skepticism. we found that circulating conspiracy theories about the coronavirus vaccination have taken hold among a small percentage of participants, in addition to more common misconceptions about vaccines. further research is needed to develop effective strategies to combat conspiracy theories and misinformation (34). some participants in our study also cited prior experience with the influenza vaccine "not working" as a reason to believe a vaccine against the coronavirus will not be effective, demonstrating the negative effects of perceived ineffective vaccines on overall vaccine acceptance. given the real possibility for variable rates of effectiveness among the covid-19 vaccines currently in development and the possible need for revaccination, public health officials might consider proactively acknowledging this possibility to avoid further loss of trust if or when this happens. surprisingly, very few vaccine-hesitant participants indicated a need or desire for a recommendation from a physician. however, there is evidence that patients whose physicians recommend a vaccine are more likely to be vaccinated than patients who do not (35). it has been argued that physicians are well-positioned to address misinformation, discuss risk, and convey the seriousness of covid-19 in a way that is tailored to the unique needs of the individual patient during an encounter (36). such conversations may be the ideal but may be difficult to implement in time-limited primary care encounters, where there are typically many competing priorities. in addition, the effectiveness of such conversations will almost certainly depend on the patient having trust in the physician and the physician having the requisite time, skills, and comfort to address the emotion-laden topic of vaccine hesitancy. given the time constraints of primary care and the potential need for physicians to receive additional training to enable them to successfully address vaccine-related concerns, health systems might consider an alternative strategy in which trained vaccine counselors use motivational interviewing to engage vaccine-hesitant individuals. this approach has been effective at increasing rates of infant vaccine coverage and adolescent human papillomavirus vaccination (37, 38). we have identified characteristics, such as not previously receiving an influenza vaccine, that are readily available in the electronic health record and could easily be used to identify covid-19 vaccine-hesitant individuals who might especially benefit from the motivational interviewing approach. our findings suggest that a multipronged approach may be needed in which trusted physicians promote vaccine uptake against a backdrop of innovative approaches and channels to combat vaccine misinformation, consistent with the body of literature of strategies to address vaccine hesitancy (39). a strength of our study is that the large, nationally representative sample allows generalization of our findings. in addition, the timing of the survey administration coincided with a peak time of the pandemic in many parts of the united states, making the findings particularly timely and salient. our study also has limitations. first, we queried individuals about their intent to be vaccinated at a time when a vaccination is not yet available. it is possible that as more details regarding a potential vaccine are known, some participants who indicated their response depended on additional information may change their response. in addition, our study was not designed to determine what additional information is needed, or how best to deliver it. future research is needed to better delineate the types of assurances needed and the messengers most likely to be trusted (for example, community leaders and religious leaders). in conclusion, we found that a substantial proportion (42.2%) of participants in a national survey conducted during the coronavirus pandemic would be hesitant to accept vaccination against covid-19. black race was one of the strongest independent predictors of not accepting vaccination; this is especially alarming, given the outsized impact of covid-19 among african-americans. our findings suggest that many of the individuals who responded "not sure" may accept vaccination if given credible information that the vaccine is safe original research attitudes toward a potential sars cov-2 vaccine among u.s. adults and effective. as vaccine development proceeds at an unprecedented pace, parallel efforts to proactively develop messages to foster vaccine acceptance are needed to achieve control of the covid-19 pandemic. 2) "there is no way i trust big pharma companies." vaccine development or testing processes 11 (5.0) 2 (2.4) "i'm thinking a vaccine now might be approved too quickly because of political pressure." "rushing to get a vaccine out will be a danger." continued on following page world health organization. coronavirus disease (covid-19): situation report 106. world health organization; 2020. accessed at www.who.int/docs/default-source/coronaviruse/situation-reports /20200505covid-19-sitrep-106.pdf?sfvrsn=47090f63_2 on 9 the socio-economic implications of the coronavirus pandemic (covid-19): a review asian critical care clinical trials group. intensive care management of coronavirus disease 2019 (covid-19): challenges and recommendations what worries the world topline & methodology. 2020. accessed at www.ipsos.com /sites/default/files/ipsos-coronavirus-us-aggregate-topline-050120 vaccines through centuries: major cornerstones of global health. front public health herd immunity": a rough guide current status of potential therapeutic candidates for the covid-19 crisis microneedle array delivered recombinant coronavirus vaccines: immunogenicity and rapid translational development accessed at www.nytimes.com/interactive/2020 /science/coronavirus-vaccine-tracker national update on measles cases and outbreaks-united states who releases list of 10 threats to global health institute for health metrics and evaluation projected population benefit of increased effectiveness and coverage of influenza vaccination on influenza burden in the united states estimate of the basic reproduction number for covid-19: a systematic review and meta-analysis predicting willingness to vaccinate for covid-19 in the us the prevalence of limited health literacy health literacy and preventive health care use among medicare enrollees in a managed care organization hospitalization rates and characteristics of patients hospitalized with laboratory-confirmed coronavirus disease 2019 -covid-net, 14 states racial and ethnic disparities in sars-cov-2 pandemic: analysis of a covid-19 observational registry for a diverse u.s. metropolitan population. medrxiv. preprint posted online 12 the influence of social norms on flu vaccination among african american and white adults open ended if not sure: what makes you unsure whether you will get the vaccine?open ended what is your best guess as to whether you will get the coronavirus within the next 6 months? i don't think i will get the coronavirus i think i will get a mild case of the coronavirus i think i will get seriously ill from the coronavirus i have already had the coronavirus appendix reference to specific conspiracy theories 6 (2.7) 6 (7.2) "[. . .] i personally do not believe that the virus was fully caused by infected animals in wuhan.[. . .] i believe that the vaccine is a governmental covert method to kill off more people, and then some." "as long as bill gates is involved with any of this, there's no way in hell i or anyone in my family would do this." "because i heard the government was to put a chip in you when you get the vaccination and i do not want a chip inside of me." distrust unspecified 2 (1.0) 13 (15.7) "i don't trust them." key: cord-258223-8dhtwf03 authors: chow, cristelle; shahdadpuri, raveen; kai-qian, kam; hwee, chan yoke title: the next pandemic: supporting covid-19 frontline doctors through film discussion date: 2020-09-05 journal: j med humanit doi: 10.1007/s10912-020-09662-2 sha: doc_id: 258223 cord_uid: 8dhtwf03 this paper describes an innovative just-in-time health humanities programme to educate and provide support to covid-19 frontline doctors-in-training. the programme incorporates small-group screening of the netflix documentary, the next pandemic from the explained series, followed by a one-hour facilitated discussion to explore themes surrounding the current pandemic and its impact on frontline doctors in a tertiary paediatric hospital in singapore. themes derived from the film included preparedness, blame, and the impact on healthcare workers and public, which were further discussed to include concerns regarding current local readiness levels given global connectivity, the need for international cooperation, and the effects of blame such as racism and prejudice. the association with culture; the current impact on healthcare workers, physician-patient relationships, and the public including the role of social media, the government and associated public reactions were also explored. these rich discussions demonstrate the pivotal role health humanities has in times of uncertainty such as an emerging infectious disease outbreak by providing timely pandemic education and supporting reflective learning. the term, "cinemeducation," coined by alexander, hall, and pettice (1994, 430) , refers to the use of movie clips to educate medical students and residents about the psychosocial aspects of medicine. films, because of their audio-visual nature, can both engage and enthral viewers with emotional and dramatic portrayals of individual struggles and challenging interpersonal relationships. when health conditions, whether physical or psychological, drive or are explored in the film's themes, viewers can gain a deeper appreciation of the illness experience (powley and higson 2005) . especially for individuals training in the healthcare professions, movies can engage learners in deeper discussion and promote active learning through cognitive and social constructivism. learners embed new knowledge acquired from the film onto pre-existing cognitive structures and construct knowledge through group discussions with other learners, reflecting upon their personal experiences along the way. a systematic review by darbyshire and baker (2012) provides insights into the various areas in which cinema is used in medical education, ranging from hard science topics like biology and virology to soft skills like professionalism and ethics. while movies can be used for the teaching of many aspects of medicine, the use of movies in providing education and support during acute outbreak situations has yet to be described, as the health humanities is often viewed as a component of "peace time" education. the uncertainty of an emerging infectious disease can have significant psychological impact on frontline doctors (tan 2020; lai et al. 2019) , and provision of the health humanities during this period could potentially help to provide just-in-time education and address perceptions of safety, threat and risk (rambaldini et al. 2005) . hence, as the world experiences the current covid-19 pandemic situation, this study aims to describe the use of a short film and post-film discussion to educate and support frontline doctorsin-training during an acute emerging infectious disease outbreak. this study also aims to broadly describe the discussion themes generated through this just-in-time intervention (table 1) . from 10 february 2020 onwards, the department of paediatrics in a tertiary women's and children's hospital in singapore assigned rotating groups of house medical staff and paediatric consultants into isolation wards designated for suspect and confirmed covid-19 paediatric cases. rotations for house medical staff were in two-week blocks including weekends and public holidays, in a twelve-hour shift system. dyads consisting of related paediatric and adult patients were also admitted to these wards. in mid-february 2020, singapore experienced an increasing number of covid-19 infected cases in the adult healthcare institutions. in our institution, we had admitted a dyad of infected infant and mother in our isolation unit by 10 february 2020 (kam et al. 2020 ). there was still significant uncertainty about the virus' transmissibility, virulence and potential to cause morbidity and mortality. all house medical staff posted to isolation wards, consisting of freshly graduated house officers, medical officers (in non-training positions), paediatric junior residents, senior residents and resident physicians were invited to the film screening during their shift hours. participation was voluntary, and all participants were informed that a post-film discussion with notetaking by the facilitators would be carried out. facilitators consisted of paediatric faculty from general paediatrics, intensive care and infectious diseases, and some facilitators were teleconferenced into the discussion due to the hospital's enforced modular system. the film was selected based on recommendations by baños and bosch (2015) . two faculty members (cc and rs) reviewed several pandemic-related films of varying durations to assess its suitability and relevance for this study. the decision was made to screen the short documentary from the original netflix explained series entitled, the next pandemic. it was selected due to its timely recent release (7th november 2019), directness, factuality, short runtime of just over twenty minutes, relevance to the current hospital climate, and feature of severe acute respiratory syndrome (sars) which significantly impacted singapore in 2003 (tan 2006) . the above-mentioned faculty members independently watched the film multiple times to determine its underlying themes, generate educational objectives and questions to be used in the post-film discussion. the educational objectives of the session were: (1) to know the significant historical pandemics that impact ongoing pandemic preparedness efforts, (2) to discuss the challenges associated with the current pandemic and (3) to reflect on the impact of the current pandemic on personal lives, healthcare workers and the general public. three questions were selected for post-film discussion: (1) how did the film make you feel about the current covid-19 situation? (2) how has frontline covid-19 work impacted your personal lives, your families and your relationships with your patients? (3) how do you feel about the public's response to the covid-19 pandemic? the session started with projection of the documentary to a small group of not more than twelve participants. this was followed by a post-film discussion facilitated by faculty members for approximately one hour. facilitators encouraged active participation using the prepared questions although new and more relevant issues emerged during the session. participants and faculty members interactively exchanged their opinions in a nonjudgemental and constructive way, using the film as the initial basis of discussion, then branching out into new discussion areas. during the session, facilitators took notes of the broad themes discussed, including relevant quotes from participants. notes taken by facilitators were thematically analysed by the study authors independently for recurring themes. this was followed by discussion among the authors, and the final themes that were mutually agreed were organized in relation to the pre-determined themes from the film. a total of six similar sessions were conducted between 10 february and 6 march 2020, involving a total of sixty-three participants and six faculty members. of the sixty-three participants, twenty-eight were paediatric senior residents and resident physicians, four were paediatric junior residents, fourteen were non-trainee medical officers, and fifteen were house officers. of the faculty members, three were paediatric infectious disease physicians, two were general paediatricians, and one was a paediatric intensivist. from the film, four issues in particular were depicted as the main themes for group discussion, which included the following: pandemic preparedness, the allocation of blame, the impact on healthcare workers and the impact on the general public. during the film discussion, these were further branched into other areas of discussion by the participants (table 1) . participants were asked the question of whether the country, hospital and the public were truly prepared for the pandemic. they reflected upon the film's depiction of sars, and how the authorities in affected countries had "let it pass" until there was a significant number of deaths. they questioned whether we had really learnt from the sars outbreak and expressed helplessness, fear, uncertainty and being overwhelmed by the possibility of an uncontrollable pandemic. these perceptions were more prevalent in the discussions that were held in mid-february 2020 when the outbreak had still not peaked. a few residents shared that their fear stemmed from the uncertainty of how lethal the virus was and that preparation, vaccine research, personal protective equipment and border controls may not be sufficient to control the spread of the virus should it be virulent and highly transmissible. in discussions held in late-february and early march, participants expressed less concern about preparedness despite the increasing number of suspect and confirmed cases, as no healthcare workers were infected, and mortality rates were lower than sars. some of them also mentioned their personal preparedness and comfort due to the presence of adequate personal protective equipment and training: "i don't think anyone is really fearful to be in the eid teamthat says a lot about our preparedness." many comparisons were made between sars and covid-19 with one of the largest differences being the current increased global connectivity of humans because of the affordability and availability of air travel. as singapore is an international transport, trade and travel hub, participants raised concerns about border control methods and whether they were timely or effective in controlling the spread of the virus to the local population. participants recognized the need for international cooperation as one resident shared that the film "makes us feel vulnerable… that we should unite as a human race as this virus transcends gender, race, socioeconomic status…." there were genuine concerns raised that the pandemic preparedness was "not high on the agenda of some governments" and that insufficient funding and resources were being designated for this purpose. participants lamented about the "rise of ultra-nationalism" and self-preservation that would only backfire, as international cooperation and putting aside political and social differences would be key to tackling this pandemic. just as the film subtly apportions blame of the sars epidemic to china (and its wet markets selling live and wild animals), some residents felt that since the start of the covid-19 outbreak, this blame was manifesting in some countries as racism and prejudice. several participants reflected upon the experiences of loved ones in western countries who were "looked at in a particular way" or treated differently due to being of chinese descent or asian ethnicity. the discussion with regards to the role of traditional wet markets was particularly lively as participants shared that southeast asian countries still have a thriving live wet market scene, which is still very much the cultural norm. it was acknowledged that while live wet markets where "the meat is fresh" are indispensable to many asian communities, the consumption of undomesticated wild animals was not widespread. in china, this practice has been typically associated with higher social status and deep-seated beliefs about the perceived nutrition value of exotic meats. hence, while the general public may be quick to blame others for being the source of the current pandemic, participants reflected that we should also look to our own practices and not be too quick to judge the culture and beliefs of others. while working on the ground, most participants felt safe wearing personal protective equipment (ppe) provided by the hospital. some even mentioned that they did not flinch when they were coughed upon by patients while wearing ppe, and one participant shared: "we're mask fitted, papr (powered air-purifying respirator) trained, and just this feeling that we are well taken care of." however, given initial reports about asymptomatic covid-19 carriers, some participants were concerned whether they were safe in public areas such as on public transport, as they perceived that they were "more likely to get covid in (trains) rather than from the ward because of the precautions that we take in hospital." participants had differing opinions on disclosure to their families about their hospital work. some participants, especially those who had family members who were also healthcare workers (hcw) , were open about their role in the isolation ward. some of them declared to their loved ones, "i'm dirty… i'm a potential centre for a new cluster" and voluntarily cancelled their social appointments for the period when they worked in the isolation wards. others had decided to "censor information," as they did not want their family members to fear for their well-being. one participant shared that it was "tiring reasoning with every patient then going home and reasoning with family." most family members were supportive of the participants' jobs especially if they were kept informed about the hospital environment and measures taken to minimise transmission to healthcare workers. family members who were also healthcare personnel tended to express more understanding and less paranoia around the fact that the participants were looking after potentially infected or infected patients. however, some participants shared that their family members were still anxious and fearful of contracting the virus from the participants. one frontline staff mentioned that his parents called him "a virus" and kept their distance from him whilst at home, while others provided anecdotes about family members refusing to meet them at social events especially if they were elderly or parents of young children. however, the participants respected the wishes of their loved ones, as one shared, "i can't blame them, they are not wrong, (the elderly person) is more likely to develop a more severe illness." while most participants did not personally experience any overt hcw discrimination, a few shared thoughts about news circulating on social media that made them concerned about this rising trend. it was reported that local nurses in hospital uniforms were chased off public transport and told to leave public eateries due to public fears about contracting the virus from hcw. one participant recounted an episode of a private hire car driver cancelling his ride to the hospital when the participant shared that he was a doctor going to work. in later sessions, participants noted that there were fewer reports of discrimination against hcw and that the public had started to show more support through notes of encouragement, as well as retail, food and beverage promotions and discounts from local businesses. communication with caregivers was deemed the most important task whilst working in the isolation ward. although it was time-consuming, participants felt that caregiver reassurance was key to ensuring adherence to hospital isolation policies and recommended treatment plans. one resident reflected the importance of "having a bit more of a personal touch… reassuring (caregivers) that measures are being taken and the reasons why isolation is as such." anxiety levels of caregivers in the isolation ward were felt to be higher compared to the other general wards, not only due to covid-19 concerns but also due to the heightened movement restrictions associated with isolation ward admissions. with the need for constant ppe use, there was more physical distance between physicians and patients, inability to see the hcw facial expressions and other non-verbal cues, some challenges in obtaining language interpreters, breathlessness with n95 masks and fogging of goggles resulting in physicians' discomfort and hence shorter-than-desired consultations. there were also discernible fears of some young children in seeing healthcare staff wearing "spacesuits" especially when obtaining nasopharyngeal specimens for viral testing, although participants tried to reduce patient anxiety through "waving from outside and walking in slowly." participants mostly felt that stepping up to the frontline during a disease outbreak was their duty and one of the reasons for entering the medical profession. in response to individuals who had reservations about working in isolation wards, one participant reflected, "we entered this profession for a reason… in a time of need, how can others refuse to do their duty?" there was heightened appreciation for non-medical healthcare workers, including nurses, who must "stay in the ward and wear the n95 throughout their shift," porters, lab technicians and ancillary staff such as the porters and cleaners. one participant described watching cleaners wearing n95 masks who were diligently detaching and disinfecting wheelchair components and was "very impressed by the effort." a significant difference between the time of sars and the current covid-19 pandemic is the widespread ubiquity and availability of social media (e.g. whatsapp, facebook, instagram). social media was viewed as a "double-edged sword"; on one hand, it provides the public with government-sanctioned information and updates, but on the other hand, it can spread fake news and fuels unwarranted rumours and panic. through social media, personal stories can surface, and different sides of the story can be publishedfor example, one participant shared the heart-warming posts of chinese citizens caring for each other during the wuhan lockdown, which contrasted with undercover videos of chinese hospitals dealing with throngs of patients. overall, social media was still viewed as a positive tool for information dissemination, as long as it was adequately regulated and the public was directed to appropriate and reliable sources of information. participants were collectively concerned about the "uninformed public," as reflected through panic buying and hoarding of daily necessities when the ministry of health escalated to a higher level of disease outbreak response system condition (also known as dorscon) from yellow to orange on 7th february 2020. controlling public reaction was viewed as a major challenge as participants felt that they could not influence members of the public who refused to abide to government recommendations -"if people do not buy in, (we) cannot force it down." however, participants recognized that as healthcare workers, it was also their responsibility to provide accurate information to the public, whether to concerned family members or doubting caregivers in order to increase public trust in government authorities and reduce irrational and selfish public behaviour. it was also agreed that healthcare workers should be consistent in their messaging and set good examples in following government advisories such as avoiding panic buying and hoarding behaviour and not wearing n95 masks in public places where it is not clinically necessary (as this would lead to over consumption of limited n95 supplies). one resident shared that healthcare workers were key to "educating the public to really filter through information that is coming through… and how to react to things when they happen." most participants felt that the government had built up public trust through decisive responses and transparent decision-making processes. they felt that they could trust the authorities to take the necessary steps, whether in border control measures, healthcare advisories or contact tracing efforts in order to protect the local population and reduce the virus' transmission within the community. however, there was some debate on whether the extent of disclosure of positive cases' personal information to the public domain was appropriate, as there was concern about the stigma experienced by positive cases and their family members. one resident shared a personal experience of a close family friend who had recently returned from wuhan, the first epicentre of the virus, and the discrimination that the family experienced despite being tested negative for covid-19. participants recognized the fine balance between government transparency and personal data protection, and that "there must be bodies in place to scale down and to decide on what is necessary and what is not," as this would also change as the pandemic evolves. although a handful of participants were initially sceptical about the public's demonstration of appreciation for the hcws, gestures including hand-written notes of gratitude, donation of food items and artworks were generally welcome. some participants also shared that caregivers of both positive and suspect patients had verbally expressed their appreciation to the healthcare team during ward rounds, and admitted children had drawn thank-you cards for nurses and doctors. these simple gestures served as positive motivators for the frontline team. our study demonstrates the feasibility of a short documentary film in generating reflective discussions about an ongoing pandemic and its impact on frontline workers. this health humanities intervention primarily uses the principles of reflection and experiential learning in medical education. reflection, the metacognitive process that creates greater understanding of self and situations to inform future action, has been used in various medical educational approaches (sandars 2009 ). in the health humanities, reflection is encapsulated in the studentcentred affective developmental approach, which focuses on the development of self-concept, insight and introspection through the exploration of feelings, attitudes and values (self 1993) . guided reflection through discussions, rather than reflective writing, was used in this intervention in order to provide participants a safe and supportive environment to make sense of their personal experiences, through non-judgmental questioning and acceptance of different opinions within the group (sandars 2009 ). incorporating the principles of the experiential learning cycle, reflection is the second phase after experience, followed by "abstract conceptualisation" (kolb 2014, 50) . in this manner, as participants watch the film, they reflect upon how the themes presented through the film relate to their personal experiences of working in the isolation wards during the covid-19 pandemic. as they share these reflections during the film discussion, they conceptualize new ideas about the ongoing pandemic including its impact on their personal lives, the healthcare system, government authorities and society. being a collaborative group discussion, aspects of social constructivism also contribute to the learning process, as the participants' knowledge is co-constructed through learning from each other's personal experiences and opinions (vygotsky 1978) . it is also hoped that this intervention provides peer support and encouragement to the participants, improving their mental wellness as they work in the high-risk areas during this pandemic. some of the themes that emerged from the discussion were similar to those reported in other studies that explored the impact of emerging infectious diseases on house staff or medical residents. for example, during the sars outbreak in toronto, medical residents expressed concerns about personal safety and the wellbeing of loved ones, their sense of duty to care, as well as feelings about social isolation (rambaldini et al. 2005) . while study participants felt confident about ppe and hospital infection control policies, they were also worried about asymptomatically passing on the virus to their loved ones as asymptomatic transmission of sars-cov-2 was a real possibility, in contrast to the sars virus. the impact of social isolation, whether self-imposed or imposed by others, could have a minimized impact on study participants compared to frontline workers during sars, due to the current widespread use of video chats and social media, which were not available in the early 2000s. during the middle eastern respiratory syndrome (mers) outbreak, medical residents reported concerns about personal and hospital preparedness and fear of disclosure about their frontline work to family members (aldrees et al. 2017) . although study participants did share that the film questioned the world's preparedness for the next pandemic, when it came to hospital infection control policies, personal protection and ppe training, the majority of study participants felt adequately prepared about working in isolation wards, and there was significant trust in the government's and hospital's management of the worsening outbreak. like medical residents in saudi arabia, some study participants chose to withhold information about their frontline work to family members. as a conservative asian society, it is still common practice to withhold information about personal health and safety risks from the affected patient, so as to not cause unnecessary worry and anxiety among family members, especially those who may be elderly or less educated. the responses of the participants evolved over the course of four weeks with initial fears and anxiety being replaced with more certainty about preparedness. this evolution was likely related to better understanding of the novel coronavirus, the local and global response to the virus, and the extent of control. participants also experienced the "normalization" of working in an outbreak settingas hcws gain acceptance of the crisis and with increasing positive cases, they would experience less apprehension as positive cases start to become the "norm." towards the last few sessions, it appeared that participants accepted that caring for suspect and positive cases would become the mainstay of their clinical work. however, without a heightened sense of vigilance, this "normalization" may result in a lapse in infection control measures. hence, it would be prudent to ensure that frontline workers are constantly provided with appropriate infection control and policy updates to ensure that vigilance and selfprotection are still maintained as the pandemic ensues. an additional pandemic-related theme that has not been previously reported is the apportioning of blame and its subsequent effects of racism and prejudice. in the film, the vivid and somewhat unsettling scenes of chinese wet markets selling live animals during the sars epidemic could have triggered unhappiness over the similarities to which the source of the sars and covid-19 outbreaks may have originated from. while there was frustration about how governments did not seem to learn from past mistakes, participants also had the opportunity to reflect upon the challenges that governments face in banning practices that are deeply rooted in the society and culture. the discussion enabled participants to also reflect on our own personal biases and not let them cloud our judgement of others and their actions. the doctor's role in the education of the public was also repeatedly discussed. participants saw themselves as representatives beyond the hospital setting as role models for the public to follow government advisories and to protect patient confidentiality. their ability to accept this additional responsibility likely stemmed from their reflection on current public behaviours and their considerable impact. this provided them with an opportunity to generate insight on how they perceived their role as healthcare professionals and allowed them to explore the rationale behind their behaviours and attitudes during this time of international crisis (ginsburg and lingard 2006) . while participants' responses on the transparency and actions of the government may be quite unique to this study's setting, exploration of this theme in other settings would also be a worthwhile endeavour in hospital pandemic responses, as trust in health and government authorities can have a significant impact on the mental wellbeing of healthcare staff. finally, it was heartening to see that participants were able to reflect upon the importance of appreciating all staff working in healthcare, and while the public may view the true "heroes" as being doctors and nurses, we need to be mindful of the other silent healthcare workers in our midst who are indispensable in combating this pandemic. this study is limited by the number of participants, but despite the small sample size, there was significant heterogeneity in the background and experiences which would have provided significant breadth in discussion. in fact, data saturation was reached by the last session as there were no further new emerging themes. further research is needed to determine if health humanities interventions can further impact participants beyond the sessions, especially in their responses to future pandemics and in their mental wellness as the pandemic continues to rage on locally and throughout the world. as the health humanities is gradually integrated into mainstream medical school and postgraduate medical curricula, just-in-time interventions have a role in providing healthcare professionals with education and support through the current worldwide pandemic. while the focus of this study was on the implementation of a timely film screening and discussion, the themes that emerged from the guided reflections were insightful and can inform future pandemic-preparedness efforts for frontline healthcare staff. medical residents' attitudes and emotions related to middle east respiratory syndrome in saudi arabia cinemeducation: an innovative approach to teaching psychosocial medical care using feature films as a teaching tool in medical schools a systematic review and thematic analysis of cinema in medical education using reflection and rhetoric to understand professional behaviours a well infant with coronavirus disease 2019 with high viral load experiential learning: experience as the source of learning and development factors associated with mental health outcomes among health care workers exposed to coronavirus disease the arts in medical education: a practical guide the impact of severe acute respiratory syndrome on medical house staff: a qualitative study the use of reflection in medical education: amee guide no. 44 the educational philosophies behind the medical humanities programs in the united states: an empirical assessment of three different approaches to humanistic medical education psychological impact of the covid-19 pandemic on health care workers in singapore sars in singapore -key lessons from an epidemic publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. key: cord-025843-5gpasqtr authors: wild, karoline; breitenbücher, uwe; képes, kálmán; leymann, frank; weder, benjamin title: decentralized cross-organizational application deployment automation: an approach for generating deployment choreographies based on declarative deployment models date: 2020-05-09 journal: advanced information systems engineering doi: 10.1007/978-3-030-49435-3_2 sha: doc_id: 25843 cord_uid: 5gpasqtr various technologies have been developed to automate the deployment of applications. although most of them are not limited to a specific infrastructure and able to manage multi-cloud applications, they all require a central orchestrator that processes the deployment model and executes all necessary tasks to deploy and orchestrate the application components on the respective infrastructure. however, there are applications in which several organizations, such as different departments or even different companies, participate. due to security concerns, organizations typically do not expose their internal apis to the outside or leave control over application deployments to others. as a result, centralized deployment technologies are not suitable to deploy cross-organizational applications. in this paper, we present a concept for the decentralized cross-organizational application deployment automation. we introduce a global declarative deployment model that describes a composite cross-organizational application, which is split to local parts for each participant. based on the split declarative deployment models, workflows are generated which form the deployment choreography and coordinate the local deployment and cross-organizational data exchange. to validate the practical feasibility, we prototypical implemented a standard-based end-to-end toolchain for the proposed method using tosca and bpel. in recent years various technologies for the automated deployment, configuration, and management of complex applications have been developed. these deployment automation technologies include technologies such as chef, terraform, or ansible to name some of the most popular [27] . additionally, standards such as the topology and orchestration specification for cloud applications (tosca) [20] have been developed to ensure portability and interoperability between different environments, e.g., different cloud providers or hypervisors. these deployment automation technologies and standards support a declarative deployment modeling approach [9] . the deployment is described as declarative deployment model that specifies the desired state of the application by its components and their relations. based on this structural description a respective deployment engine derives the necessary actions to be performed for the deployment. although most of these technologies and standards are not limited to a specific infrastructure and able to manage multi-cloud applications, they all use a central orchestrator for the deployment execution. this central orchestrator processes the declarative deployment model and either forwards the required actions in order to deploy and orchestrate the components to agents, e.g., in the case of chef to the chef clients running on the managed nodes, or executes them directly, e.g., via ssh on a virtual machine (vm), as done by terraform [25] . however, today's applications often involve multiple participants, which can be different departments in a company or even different companies. especially in industry 4.0 the collaboration in the value chain network is of great importance, e.g., for remote maintenance or supply chain support [7] . all these applications have one thing in common: they are cross-organizational applications that composite distributed components, whereby different participants are responsible for different parts of the application. the deployment and management of such applications cannot be automated by common multi-cloud deployment automation technologies [22] , since their central orchestrators require access to the internal infrastructure apis of the different participants, e.g., the openstack api of the private cloud, or their credentials, e.g., to login to aws. there are several reasons for the involved participants to disclose where and how exactly the application components are hosted internally: new security issues and potential attacks arose, legal and compliance rules must be followed, and the participant wants to keep the control over the deployment process [17] . this means that common centralized application deployment automation technologies are not suitable to meet the requirements of new emerging application scenarios that increasingly rely on cross-organizational collaborations. in this paper, we address the following research question: "how can the deployment of composite applications be executed across organizational boundaries involving multiple participants that do not open their infrastructure apis to the outside in a fully automated decentralized manner?" we present a concept for the decentralized cross-organizational application deployment automation that (i) is capable of globally coordinating the entire composite application deployment in a decentralized way while (ii) enabling the involved participants to control their individual parts locally. therefore, we introduce a global multi-participant deployment model describing the composite crossorganizational application, which is split into local parts for each participant. based on the local deployment models a deployment choreography is generated, which is executed in a decentralized manner. based on the tosca and bpel [19] standards the existing opentosca ecosystem [6] is extended for the proposed method and validated prototypically. for application deployment automation two general approaches can be distinguished: declarative and imperative deployment modeling approaches [9] . for our decentralized cross-organizational application deployment automation concept both approaches are combined. most of the deployment automation technologies use deployment models that can be processed by the respective deployment engine. deployment models that specify the actions and their order to be executed, e.g., as it is done by workflows, are called imperative deployment models, deployment models that specify the desired state of an application are called declarative deployment models [9] . we explain the declarative deployment models in a technology-independent way based on the essential deployment meta model (edmm) that has been derived from 13 investigated deployment technologies in previous work [27] . the meta model for declarative deployment models presented in sect. 3 is based on the edmm and is the basis for the declarative part of the presented concept. in edmm an application is defined by its components and their relations. for the semantic of these components and relations reusable component and relation types are specified. for example, it can be defined that a web application shall be hosted on an application server and shall be connected to a queue to publish data that are processed by other components. for specifying the configuration of the components properties are defined, e.g., to provide the credentials for the public cloud or to set the name of the database. for instantiating, managing, and terminating components and relations executable artifacts such as shell scripts or services are encapsulated as operations that can be executed to reach the desired state defined by the deployment model. the execution order of the operations is derived from the deployment model by the respective deployment engine [5] . in contrast, imperative deployment models explicitly specify the actions and their order to be executed to instantiate and manage an application [9] . actions can be, e.g., to login to a public cloud or to install the war of a web application on an application server. especially for complex applications or custom management behavior imperative deployment models are required, since even if declarative models are intuitive and easy to understand, they do not enable to customize the deployment and management. imperative deployment technologies are, e.g., bpmn4tosca [16] , and general-purpose technologies such as bpel, bpmn [21], or scripting languages. in general, declarative deployment models are more intuitive but the execution is less customizable, while imperative deployment models are more complex to define but enable full control of the deployment steps. therefore, there are hybrid approaches for using declarative models that are transformed into imperative models to get use of the benefits of both approaches [5] . in this paper, we follow this hybrid approach by transforming declarative models to imperative choreography models. this means, the user only has to specify the declarative model and, thus, we explain the declarative modeling approach in sect. 4 using a motivating scenario. first, in the next section the meta model for declarative deployment models is introduced. our approach presented in sect. 5 is based on declarative deployment models that are transformed into imperative choreographies. based on edmm and inspired by the declarative application management modeling and notation (dmmn) [3] , the gentl meta model [1] , and tosca, a definition of declarative deployment models d ∈ d is introduced: model) . a declarative deployment model d ∈ d is a directed, weighted, and possibly disconnected graph and describes the structure of an application with the required deployment operations: the elements of the tuple d are defined as follows: declarative deployment model specifying all details of the desired application. the notation is based on vino4tosca with components as nodes, relations as edges, and the types in brackets [4] . in addition, sample operations are shown as dots. following the design cycle by wieringa [26] , we first examined the current situation in various research projects with industrial partners, namely in the projects ic4f 1 , sepia.pro 2 , and smartorchestra 3 . with regard to horizontal integration through the value chain network in the context of industry 4.0, we focused on the requirements and challenges of collaboration between different companies [7] . based on our previous research focus, the deployment and management of applications, the following research problems have emerged: (a) how can the deployment of composite applications across organizational boundaries be automated in a decentralized manner? (b) what is the minimal set of data to be shared between the involved participants to enable the automated decentralized deployment? in fig. 1 queue and database, respectively. in addition, three operations are exemplary shown: a connectsto to establish a connection to the queue, a connectsto to connect to the database, and an install operation to install the jar artifact on the order vm. the other properties and operations are abstracted. assuming that a single organization is responsible for deploying the entire application and has full control over the openstacks and aws, the common deployment automation technologies examined by wurster et al. [27] fit perfectly. however, in the depicted scenario two participants, p1 and p2, who may be different departments or companies, intend to realize a cross-organizational application so that common deployment automation technologies are no longer applicable. while all participants must agree on the application-specific components, the underlying infrastructure is the responsibility of each participant. for security reasons, participants typically do not provide access to internal apis, share the credentials for aws, or leave the control over deployment to others. to address the research problems, we propose a decentralized concept to enable the cross-organizational application deployment automation ensuring that (i) only as little data as necessary is exchanged between participants and (ii) each participant controls only his or her local deployment while the overall deployment is coordinated. the proposed solution is described in detail in the following section and in sect. 6 the implementation and validation is presented. the motivating scenario in fig. 1 serves as use case for the validation. for the decentralized cross-organizational application deployment automation with multiple participants, it has to be considered that (i) the participants want to exchange as little data as necessary and (ii) each participant controls only his or her local deployment while the global coordination of the deployment of the entire application is ensured. taking these requirements into account, we have developed the deployment concept depicted in fig. 2 . in the first step, the application-specific components are modeled representing the use case to be realized. they typically include the business components such as the order app, storage components such as the database component, and communication components such as the order queue in fig. 1 . in the second step, the global multi-participant deployment model (gdm) is generated, a declarative deployment model containing all publicly visible information that is shared between the participants. this publicly visible information contains also data that must be provided by the respective infrastructure. for example, to execute the operation to establish a connection between order processor and database in fig. 1 , the ip of the database vm is required as input. subgraphs, so called local parts of the gdm, are then assigned to participants responsible for the deployment of the respective components. the gdm is then processed by each participant. first, in step three, for each application-specific component a hosting environment is selected and the adapted model stored as local multi-participant deployment model (ldm). in the motivating scenario in fig. 1 participant p1 selected aws for the order queue and the openstack for the order app. however, this individual placement decision is not shared. for the deployment execution we use an hybrid approach: based on the ldm a local deployment workflow model is generated in step four that orchestrates the local deployment and cross-organizational information exchange activities. all local workflows form implicitly the deployment choreography which enables the global coordination of the deployment across organizational boundaries. each step is described in detail in the following. in the initial step, the application-specific components representing the use case to be realized have to be modeled. they typically include business components, storage components, and communication components. in the motivating scenario in fig. 1 the set of application-specific components contains the order app, the order queue, the order processor, and the database. in addition, the lifecycle operations, e.g., to install, start, stop, or terminate the components and relations, have to be defined for each of these components and their relations, since all input parameters of these operations must be provided as globally visible information in the gdm. application-specific components are defined as follows: c s ⊆ c d in d, where all r s = (c s , c t ) ∈ r d with {c s , c t } ∈ c s are of type d (r s ) = connectst o and for each c i ∈ c s : cap(type d (c i )) = ∅, to ensure that the application-specific components can be deployed across organizational boundaries, the gdm is generated in the second step which contains the minimal set of necessary information that have to be globally visible, i.e., that have to be shared. thus, the gdm is defined as follows: the elements of the tuple g are defined as follows: -d ∈ d: declarative deployment model that is annotated with participants. -p g ⊆ ℘(σ + ) × ℘(σ + ): set of participants with p i = (id , endpoint) ∈ p , whereby σ + is the set of characters in the ascii table. -participant g : the mapping assigning a component c i ∈ c d to a participant p i ∈ p g participant g : c d → p g . the example in fig. 3 depicts a simplified gdm. the application-specific components, depicted in dark gray, specify requirements, e.g., the order queue requires a message queue middleware. these requirements have to be satisfied by the respective hosting environment. furthermore, for these components as well as their connectsto-relations operations with input parameters are defined. to establish a connection to the order queue the url and q-name of the queue are required. either the target application-specific component provides respective matching properties such as the q-name property exposed by the order queue component or the environment has to provide it such as the input parameter url. for this, in this step placeholder host components are generated that contain all capabilities and properties that have to be exposed by the hosting environment. -for each r j ∈ r d : π 2 (r j ) = c j with type d (r j ) = connectsto and for each operation op r ∈ operations s (r j ) all data elements v r ∈ π 1 (op r ) \ properties s (c j ) are added to properties d (c h ). in the example in fig. 3 the host order queue component provides the capability messagequeue and exposes the property url, which is required as input parameter for the connectsto operations. before the deployment model is processed by each participant, subgraphs of the gdm are assigned to the participants. this subgraph is called local part and indicates who is responsible for this part of the application. this is done by annotating the gdm as shown in fig. 3 on the right. since participants typically do not want to share detailed information about their hosting environment, the gdm is given to each participant for further processing. each participant p i has to select a hosting environment for all c s ∈ c s with participant g (c s ) = p i . in fig. 3 fig. 3 is valid because the property url is covered and the sqs exposes the required capability messagequeue. the substitution is automated by our prototype described in sect. 6 components and matching to existing infrastructure and middleware several approaches exist [12, 23, 24] . soldani et al. [24] introduced the toscamart method to reuse deployment models to derive models for new applications, hirmer et al. [12] introduced a component wise completion, and we presented in previous work [23] how to redistribute a deployment model to different cloud offerings. these approaches use a requirement-capability matching mechanism to select appropriate components. we extended this mechanism to match the properties as well. the resulting local multi-participant deployment model (ldm) is a partially substituted gdm with detailed middleware and infrastructure components for the application-specific components managed by the respective participant. up to this point we follow a purely declarative deployment modeling approach. the core step of our approach is the generation of local deployment workflow models that form the deployment choreography. they are derived from the ldms by each participant and (i) orchestrate all local deployment activities and (ii) coordinate the entire deployment and data exchange to establish crossparticipant relations. while centralized deployment workflows can already be generated [5] , the global coordination and data exchange are not covered yet. cross-participant relations are of type connectsto and between components managed by different participants. to establish cross-participant relations, the participants have to exchange the input parameters for the respective connectsto-operations. in the example in fig. 3 the relation con2 establishes a connection from the order processor managed by p2 to the order queue managed by p1. the connectsto-operation requires the url and the q-name as input. both parameters have to be provided by p1. since this information is first available during deployment time, this data exchange has to be managed during deployment: for each cross-participant relation a sending and receiving activity is required to exchange the information after the target component is deployed and before the connection is established. in addition, the deployment of the entire application must be ensured. independent which participant initiates the deployment, all other participants have to deploy their parts as well. this is covered by three cases that have to be distinguished for the local deployment workflow generation as conceptually shown in fig. 4 . in the upper part abstracted ldms and in the lower part generated activities from the different participants perspectives are depicted. on the left (a) activities from a crossparticipant relation target perspective, in the middle (b) from a cross-participant relation source perspective, and on the right (c) activities generated to ensure the initiation of the entire deployment are depicted. first, a definition of local deployment workflow models based on the production process definition [14, 18] is provided: for each participant p i ∈ p a local deployment workflow model w i based on the ldm is defined as: the elements of the tuple w i are defined as follows: set of control connectors between activities, whereby each e y = (a s , a t ) ∈ e wi represents that a s has to be finished before a t can start. set of data elements, whereby σ + is the set of characters in the ascii table and v y = (datatype, value) ∈ v wi . -i wi : the mapping assigns to each activity a y ∈ a wi its input parameters and it is called the input container i wi : a wi → ℘(v wi ). -o wi : the mapping assigns to each activity a y ∈ a wi its output parameters and it is called the output container o wi : a wi → ℘(v wi ). -type wi : the mapping assigns each a y ∈ a wi to an activity type, type wi : based on this definition, local deployment workflow models can be generated based on specific rules. in fig. 4 the resulting activities are depicted: (a) for each component c t ∈ c d that is target of a cross-participant relation r c = (c s , c t ) with participant g (c t ) = p i and participant g (c s ) = p j , an activity a t ∈ a wi : type wi (a t ) = invoke is added that invokes the start operation of c t . after a component is started, a connection to it can be established [5] . thus, a c : type wi (a c ) = send is added to w i that contains all input parameters of the connectsto-operation of r c provided by p i in o wi (a c ). (b) for the component c s ∈ c d , the source of the cross-participant relation r c , an activity a c : type wj (a c ) = receive is add to w j of p j . with the control connector e(a init , a c ) added to w j it is ensured that the activity is activated after the initiate activity of p j . after the input values are received and the start operation of c s is successfully executed, the actual connectstooperation can be executed. (c) each workflow w i starts with the initiate activity a init ∈ a wi : type wi (a init ) = receive. to ensure that after a init is called the entire application deployment is initiated, a notification is sent to all other participants. for each p j ∈ p \ {p i } an activity a n : type wi (a n ) = send with a control connector e(a init , a n ) is added to w i . since each participant notifies all others, for n participants, each participant has to discard n-1 messages. since the payloads are at most a set of key-value pairs this is not critical. each participant generates a local deployment workflow model, which together implicitly form the deployment choreography. as correlation identifier the gdm id and application instance id are sufficient. while the gdm id is known in advance, the application instance id is generated by the initiating participant. the approach enables a decentralized deployment while each participant controls only his or her deployment and shares only necessary information. to demonstrate the practical feasibility of the approach we extended the tosca-based open-source end-to-end toolchain opentosca 4 [6] . it consists of a modeling tool winery, a deployment engine opentosca container, and a self-service portal. in tosca, deployment models are modeled as topology templates, the components as node, and the relations as relationship templates with their types. the types define properties, operations, capabilities, and requirements. plans are the imperative part of tosca, for which standard workflow languages such as bpmn or bpel can be used. all tosca elements and executables, implementing operations and components, are packaged as cloud service archive (csar). in fig. 5 the system architecture for two participants is depicted. winery is extended by the placeholder generation and the placeholder substitution. either p1 or p2 models the application-specific components and generates the gdm using the placeholder generation that generates node types with the respective properties and capabilities. the resulting gdm is then packaged with the csar im-/exporter and sent to each participant. the substitution mapping detects the local part of managed by the respective participant in the gdm and selects topology templates from the repository to substitute the placeholder host components. the substituted topology template is then uploaded to the opentosca container. the plan builder generates a deployment plan based on the declarative model. we use bpel for the implementation. either p1 or p2 can then initiate the deployment. the plan runtime instantiates the plan and invokes the operations. the actual operation, e.g., to create a vm, is executed by the operation runtime. the communication between the opentosca containers is managed by the management bus. the management bus is the participant's endpoint in our setup. however, also arbitrary messaging middleware or any other endpoint that can process the messages can be used. we used the deployment model presented in fig. 1 with two and three participants for the validation. in contrast to general workflow approaches [14, 15] , we do not have to deal with splitting workflows according to the participants, since we can completely rely on the declarative deployment model and only implicitly generates a choreography. however, a prerequisite is that each participant only uses the predefined interfaces so that the choreography can be executed. at present, we also limit ourselves to the deployment aspect and do not consider the subsequent management. while management functionalities such as scaling are often covered by the cloud providers themselves, other functionalities such as testing, backups, or updates are not offered. management increases the complexity of automation, especially when local management affects components managed by other participants. we currently only support tosca as a modeling language and opentosca as a deployment engine. so far, we lack the flexibility to support technologies like kubernetes, terraform, or chef, which are often already in use in practice. however, this is part of the planned future work. the research in the field of multi-cloud, federated cloud, and inter-cloud [10, 22] focuses on providing unified access to different cloud providers, making placement decisions, migration, and management. all these approaches consider multiple cloud providers satisfying the requirements of a single user. the cloud forms differ in whether the user is aware of using several clouds or not. however, the collaboration between different users each using and controlling his or her environment, whether it is a private, public, or multi-cloud, is not considered, but this is highly important, especially in cross-company scenarios which arose with new emerging use cases in the fourth industrial revolution. arcangeli et al. [2] examined the characteristics of deployment technologies for distributed applications and also considered the deployment control, whether it is centralized or decentralized. however, also the decentralized approaches with a peer-to-peer approach does not consider the sovereignty of the involved peers and the communication restrictions. in previous work [13] , we introduced an approach to enable the deployment of parts of an application in environments that restrict incoming communication. however, the control is still held by a central orchestrator. kopp and breitenbücher [17] motivated that choreographies are essential for distributed deployments. approaches for modeling choreographies, e.g., with bpel [8] or to split orchestration workflows into multiple workflows [14, 15] have been published. however, most of the deployment technologies are based on a declarative deployment models [27] , since defining the individual tasks to be performed in the correct order to reach a desired state are error-prone. thus, instead of focusing on workflow choreographies we implicitly generated a choreography based on declarative deployment models. breitenbücher et al. [5] demonstrated how to derive workflows from declarative deployment models. however, their approach only enables to generate orchestration workflows which cannot be used for decentralized cross-organizational deployments. herry et al. [11] introduced a planning based approach to generate a choreography. however, they especially focus on generating an overall choreography that can be executed by several agents. for us the choreography is only an implicit artifact, since we mainly focus on enabling the cross-organizational deployment by minimizing the globally visible information and obtaining the sovereignty of the participants. in this paper, we presented an approach for the decentralized deployment automation of cross-organizational applications involving multiple participants. a cross-organizational deployment without a central trusted third-party is enabled based on a declarative deployment modeling approach. the approach facilitates that (i) each participant controls the local deployment, while the global deployment is coordinated and (ii) only the minimal set of information is shared. a declarative global multi-participant deployment model that contains all globally visible information is generated and split to local deployment models that are processed by each participant. each participant adapts the local model with internal information and generates an imperative deployment workflow. these workflows form the deployment choreography that coordinates the entire application deployment. we implemented the concept by extending the opentosca ecosystem using tosca and bpel. in future work the data exchange will be optimized since each participant sends notification messages to all other participant and thus for n participants n-1 messages have to be discarded. we further plan not only to enable multi-participant deployments but also multi-technology deployments by enabling to orchestrate multiple deployment technologies. a gentl approach for cloud application topologies automatic deployment of distributed software systems: definitions and state of the art eine musterbasierte methode zur automatisierung des anwendungsmanagements. dissertation vino4tosca: a visual notation for application topologies based on tosca combining declarative and imperative cloud application provisioning based on tosca the opentosca ecosystem -concepts & tools collaborative networks as a core enabler of industry 4.0 bpel4chor: extending bpel for modeling choreographies declarative vs. imperative: two modeling patterns for the automated deployment of applications inter-cloud architectures and application brokering: taxonomy and survey choreographing configuration changes automatic topology completion of tosca-based cloud applications deployment of distributed applications across public and private networks supporting business process fragmentation while maintaining operational semantics: a bpel perspective e role-based decomposition of business processes using bpel bpmn4tosca: a domainspecific language to model management plans for composite applications choreographies are key for distributed cloud application provisioning production workflow: concepts and techniques oasis: web services business process execution language version 2.0 (2007) 20. oasis: tosca simple profile in yaml version 1.2 (2019) 21. omg: bpmn version 2.0. object management group (omg multi-cloud: expectations and current approaches topology splitting and matching for multi-cloud deployments toscamart: a method for adapting and reusing cloud applications a taxonomy and survey of cloud resource orchestration techniques design science methodology for information systems and software engineering the essential deployment metamodel: a systematic review of deployment automation technologies acknowledgments. this work is partially funded by the bmwi project ic4f (01ma17008g), the dfg project distopt (252975529), and the dfg's excellence initiative project simtech (exc 2075 -390740016). key: cord-312678-81gnmxbk authors: elayeh, eman; aleidi, shereen m.; ya’acoub, rawan; haddadin, randa n. title: before and after case reporting: a comparison of the knowledge, attitude and practices of the jordanian population towards covid-19 date: 2020-10-15 journal: plos one doi: 10.1371/journal.pone.0240780 sha: doc_id: 312678 cord_uid: 81gnmxbk coronavirus disease2019 (covid-19) is an emerging contagious infectious disease. it is pandemic and has affected more than 21 million people and resulted in more than 750,000 deaths worldwide (https://www.worldometers.info/coronavirus/#countries; 14/08/20). our research group initiated a study to ascertain the knowledge, attitude and practices (kap) of jordanians toward covid-19 prior to any initial case report in jordan. this project was underway when the first jordanian case was reported. we extended our study to identify how case reporting would alter public kap towards covid-19. this cross-sectional study randomly selected and recruited 2104 jordanian adults. a four-section questionnaire was devised to address the sociodemographic characteristics of the subjects and their kap toward covid-19. the mean knowledge score for the study population was 15.9 ± 2.2 (out of the 20 knowledge questions), with 60.9% of the participants having good knowledge about covid-19. participants’ practices to prevent transmission of covid-19 were adequate in more than 60% of participants. most participants had positive attitudes regarding their role in preventing covid-19 and many of the participants’ attitudes and practices changed to more appropriate ones after reporting the first case of covid-19 in jordan. the percentage of participants who trust the government in confronting covid-19 increased significantly (p value < 0.001). however, one alarming and unexpected finding was that the prevention practice score of participants working in the medical field was similar to those from the general population. this may necessitate stricter training and guidelines for this group who will be in the frontline in combating the disease. impact of this study: the data generated from this study shows that when cases of disease were reported, the public’s attitudes and practices improved in many aspects, and that confidence in the government to contain the disease was boosted. we believe that this study is important in allowing other, international governments to develop an understanding of public kap during pandemic disease outbreaks. a1111111111 a1111111111 a1111111111 a1111111111 a1111111111 after reporting 70 cases which were all isolated in dedicated hospitals, the jordanian government applied a nationwide lockdown and activated the defense law, which allows the army and police to ensure the adherence of public to the curfew [16] . under these circumstances, where public health is threatened by the pandemic and since the people's attitudes and practices play a crucial role in limiting or spreading the disease in their community, evaluating the knowledge, attitude, and practice (kap) of the general public towards the covid-19 is crucial. therefore, the initial aim of this study was to evaluate the overall knowledge, attitude and practices (kap) of jordanian citizens to the ongoing international situation regarding the emergence and pandemic nature of covid-19. however, we were lucky that our study was almost complete when the first case of the disease was reported in jordan. hence, we rapidly adapted our study in order to engage more participants and to evaluate how this reported case altered the kap of jordanian citizens. the aim of this report is to aid decision makers in their understanding of the public knowledge and awareness of the disease, the attitudes of the public and their practices to take necessary measures to prevent disease spread. this was a cross-sectional study conducted during the early days of covid-19 pandemic of 2019 and 2020 and over the period from 12 th february to 19 th march 2020. when the study started there were no reported cases in jordan. during the study, the first covid-19 case was reported in jordan, which encouraged the authors to extend the study and include more participants in order to identify how case reporting would alter the public kap towards covid-19. the study targeted adult resident jordanian nationals. it was a questionnaire based and self-selection study. the institutional review board (irb) at the deanship of scientific research, the university of jordan, approved the study protocol and the questionnaire (irb 28/2020). the questionnaire was developed based on extensive literature review [3, [17] [18] [19] [20] . it consisted of four main sections; (a) demographic and general characteristics of the participants, (b) participants knowledge regarding covid-19, its mode of transmission, and its preventative measures (20 questions), (c) participants' attitudes towards covid-19 and its preventative measures (13 questions) , and (d) participants' practices towards prevention of covid-19 transmission (6 questions). the questionnaire content was translated from english into arabic and then critically revised and face-validated by several academic colleagues. since the jordanian general public knows covid-19 as "coronavirus disease", this term was used in the questionnaire. amendments were made according to the notes and comments received after piloting to a sample of 50 adults chosen from the friends, neighbors and coworkers of the authors. the questionnaire was then developed as a google form and disseminated to participants via mobile applications, eg: whatsapp [21, 22] . snow ball sampling technique was used to distribute the google form and enroll participants [22, 23] . the link to the google form was sent to the contact lists of the authors, in addition to neighbors, friends, relatives, coworkers of all levels and departments, friends of friends, different whatsapp groups, who were also asked to complete the form and to disseminate it to all the people they know in jordan. this method of disseminating the questionnaire was selected in view of the need to reduce direct contact with participants under the pandemic situation. participants were asked not to identify themselves in any fashion. also they were informed that completing the questionnaire and returning it were considered as a formal consent to participate in the study since the participant can, at any moment, stop answering questions or choose not to "submit" the final form. a minimum sample of 1050 adults aged 18 and older was estimated based on the following equation [24] : n ¼ where n is the sample size, zα: type one error = 1.96 when α = 5%; zβ: type two error = 1.28 when β = 10%; q = 1-p: expected non-prevalence; p = proportion in the population possessing the characteristic of interest (based on the estimate that 50% of the respondents knew general information about covid-19, its routes of transmission and the main preventative measures), d = one-half of the desired interval of confidence, in this study d = 5%. accordingly, by filling in the equation, n = 0.5x0.5 (1.96+1.28) 2 / 0.05 2 = 1049.76. statistical analysis was performed using spss version 20.0 (spss inc., chicago, il). descriptive statistics were used to describe demographic characteristics of participants. categorical variables were presented as valid percentages to account for missing data with their frequencies, while continuous variables were presented as mean with standard deviation (sd). two scores were calculated for the participants: knowledge about covid-19 and its preventative measures, and participants' practices towards preventing transmission of covid-19. participants' knowledge scores were evaluated using the number of correct questions they answered out of 20 covid-19 knowledge questions. in order to calculate the knowledge score, correct answers were assigned a score of one, while wrong or "i don't know" answers were assigned a score of zero. participants were considered adequately knowledgeable if their knowledge score, for all knowledge questions, was higher than or equal to the sample median of the knowledge score. internal consistency of the knowledge questions was tested using cronbach alpha coefficient as a reliability test. the results showed that the cronbach alpha for knowledge (20 items) was 0.7. cronbach alpha within the range 0.6 to 0.7 is considered adequate and reliable [25] . similarly, participants practice towards preventing transmission of covid-19 score was calculated by assigning a score of one for appropriate practices, while inappropriate practices were assigned a score of zero. the maximum value of practice score is six based on the total number of correct practice items. participants' knowledge, attitudes and practices were compared before and after the reporting of the first confirmed case of coronavirus in jordan which was documented on 2 nd march 2020. by default, 'google forms' identifies the date and time of each participant's response which enabled us to sort the responses submitted into those made before and after case reporting. chi-square test was used for these comparisons. parametric tests including independent sample t-test and one way anova test were used to test the differences among the variables that affect both knowledge and practice scores (bivariate analysis) as specified in the results section (data were first tested for normality using kolmogorov-smirnov (k-s) test and for homogeneity of variances using levene's test). in addition, independent sample t-test was used to test the differences in the scores between the two groups (before and after case reporting). all hypothesis testing was two-sided. a p-value of < 0.05 was considered significant. the total number of participants recruited in the study was 2104. 832 participants were recruited before case reporting and 1272 participants were recruited after case reporting. more than 50% of participants were in the age group of 18-35 (62.7%, n = 1321). females accounted for 75.4% (n = 1586) of the study population. more than 75% of participants had a university or postgraduate degree (81.6%, n = 1717), and 43�6%, (n = 917) had education in the medical field. since the cohort participating in the study after case reporting differed from those participating before case reporting, there were variations in the sociodemographic data of the two groups (p< 0.05, chi square) except for gender and working in the medical field which were similar (p>0.05). participants' sociodemographic characteristics are presented in table 1 . the mean knowledge score for the whole study population was 15.9 ± 2.2 (out of the 20 knowledge questions), with 60.9% (n = 1281) of the participants having a score equal to or higher than the median (16.0) and consequently were considered to have adequate knowledge about covid-19. only 2.4% (n = 51) of the participants were able to correctly answer all of the 20 knowledge questions and 8% (n = 168) of participants were able to correctly answer 19 questions. in addition, 17% (n = 357) of participants knew the general information related to the covid-19, its symptoms and the highest risk group. however, more than 50% of the study population incorrectly thought that death is a common complication of covid-19 (44.2%, n = 929) ( table 2) . regarding covid-19 transmission, a major gap of knowledge regarding routes of covid-19 transmission was identified where only 2.3% (n = 49) of the population correctly recognized all the routes of covid-19 transmission. considering covid-19 preventative measures, more than half of the participants were able to identify the main preventative measures. however, only 18.3% (n = 385) of them knew plos one that a facemask should not be used daily as a preventative measure for covid-19 transmission (which was a recommendation by who and moh at the early days of the pandemic). in general, the mean knowledge scores of participants improved after case reporting (when compared with those exhibited before case reporting) in the three areas studied: definition, signs and symptoms, risk groups and complications (mean score 5.5 ±1.2 vs 5.1 ±1.2, p<0.005); mode of transmission (mean score 3.3 ± 0.8 vs 3.2 ± 0.7, p = 0.037) and prevention of transmission and treatment (mean score 7.6 ± 1.1 vs 6.9 ± 1.1, p<0.005). accordingly, the total knowledge score was improved from 15.2 ± 2.2 before case reporting to 16.3 ± 2.1 after case reporting (p value <0.001, independent sample t-test) ( table 2 ). the detailed frequencies for individual questions are presented in table 2 . the most common source of participants' information about covid-19 was social media, such as facebook, twitter or others (64.3%, n = 1353), followed by internet searching such as google (59.4%, n = 1249), and television (49�7%, n = 1046). a much lower proportion of respondents relied on newspapers (37.3%, n = 784), friends (29.3%, n = 616), brochures (20.2%, n = 426) or physicians' offices (6.6%, n = 138) to get information. a significantly higher knowledge score (p-value < 0.001) was associated with using internet search (score = 16.4) as sources of information (p-value < 0.001; independent sample t-test), while other sources were not associated with significantly higher knowledge score. most participants had positive attitudes regarding their role in preventing covid-19. in particular, 67.2% of participants thought that they could protect themselves against covid-19 and 88.7% of them thought that following advised preventative measures would be effective. however, more than 50% of participants didn't trust the jordanian ministry of health's (moh) approach to confronting covid-19 (57.6%, n = 1211) or the information provided by governmental authorities about the exact number of cases (66.1%, n = 2091). similarly, more than half of participants believed that the occurrence of coronavirus was related to international tension and trade wars (57.9%, n = 1219) and 49.7% (n = 1046) of participants believed that the recent coronavirus was created in a laboratory and was not naturally occurring. on the other hand, most participants were either unsure or didn't believe that herbal remedies (71.7%, n = 1508) or antibiotics (85.9%, n = 1808) were effective in treating or preventing covid-19. interestingly, many of the participants' attitudes had changed after reporting the first jordanian case of covid-19 (2 nd march 2020). most importantly, the percentage of participants who believe that covid-19 was a serious and life threating infection dropped significantly from 81.6% to 52.6% (p value < 0.001; table 3 ). on the other hand, the proportion of participants who trusted moh in confronting covid-19 increased significantly from 35.9% to 46.7% (p value<0.001). similarly, the percentage of participants who thought that they could protect themselves against infection with covid-19 (59.3% vs.72.3%, p value <0.005) and those who thought that treatment approaches were effective also increased significantly (from 31.0% to 42.7%, p value = 0.009). the mean practice score of all the participants was 3.95 ± 1.7 (out of the 6 practice questions) with 66.7% (n = 1403) of the participants having a score equal to or higher than 4 and consequently were considered as having adequate practices to prevent spread of covid-19. respondents' practices are presented in table 4 . participants' practices to prevent transmission of covid-19 in terms of avoiding hand shaking, hugging, kissing and crowded areas, and using disinfectants were appropriate in more than 60% of participants. interestingly, all these practices have increased significantly after reporting the first case of covid-19. on the other hand, the proportion of participants wearing facemasks and avoiding the purchase of chinese table 4 ). overall, the observed practice score improved significantly when compared between respondents before case reporting and after case reporting (3.65 ± 1.9 vs. 4.2 ± 1.4 respectively, p value < 0.001, independent sample t-test; table 4 ). factors affecting participants' knowledge and practice towards preventing covid-19 were determined by bivariate analysis. overall participants' knowledge and practice scores were associated with age, educational level and education in health or medical field. in addition, participants' knowledge score was associated with gender and work in the medical field. participants' practice score was also associated with marital status. for each sociodemographic characteristic, the calculated knowledge score (table 5 ) or practice score ( table 6 ) was improved after case reporting when compared to the value before case reporting. detailed results are shown in tables 5 and 6 . since the who declaration of covid-19 as a public health emergency on 30 th january 2020, health authorities around the world, led by who, have initiated huge campaigns to increase the awareness of the people toward the disease and to disseminate the appropriate practices to prevent its transmission [4] . as a member of these authorities, the moh in jordan started similar campaigns relying on different forms of media. the first case in jordan was reported on 2 nd march 2020 for a citizen returning from italy [28] . our study commenced by distributing the questionnaires on 17 th february before the reporting of the first case of covid-19 in jordan, and the questionnaire process ended on 19 th march. by that time, the measures taken by the country included closure of schools and universities, quarantining thousands of incoming air passengers in hotels, and prohibiting any kind of social gathering (including the closure of all mosques and churches). during that period, the number of cases reported increased to 52 without fatality. this gave our team an opportunity to compare the change in knowledge, attitudes and practices of jordanians towards covid-19 before and after the reporting cases of covid-19 illness. the sample population of this study (2104 participants) was largely well educated with females predominating. the observed skew in the sample toward females and well educated participants has also been seen in previous studies in jordan [29] [30] [31] [32] . in addition, the vast majority of participants were below the age of 55 years, which is representative of the generally younger population of jordan, where at the end of 2019 the estimated proportion of population below 55 years was around 92% [33] . the overall knowledge of the respondents was generally adequate (total knowledge score 15.9 out of 20). they exhibited excellent knowledge of the organs targeted by the virus, its nature as a zoonotic disease, and its signs and symptoms. however, the respondents had an exaggerated idea about the expected death rate of the disease where more than 55% considered death to be a very common outcome. this idea could have been drawn in their minds due to the effect of media focus on death rates and novel cases, rather than recovered cases [34, 35] , thus, giving the audience or readers the impression that this disease is highly fatal. the respondents were well aware of the most common routes of the disease transmission, such as close contact, respiratory droplets or touching contaminated surfaces. the vast majority of participants (> 90%) had an excellent knowledge about the required measures to prevent the disease. however, the more scientific questions related to the role of influenza vaccine in protecting from covid-19 or the one related to use of a specific drug to treat the illness were correctly answered by only around two thirds the participants. the participants' knowledge was gained through multiple sources of information. the electronic sources such as social media (64%) and internet (59%) were the top sources followed by television (50%). these results suggest that in this era, where electronic media sources are predominate at the expense of more traditional media sources, health authorities should focus their healthrelated campaigns on electronic media and they should consider adding social media platforms to their public communication tools, in order to reach the vast majority of population [36] [37] [38] [39] . it is noteworthy that people who obtained their information from internet searches had significantly higher knowledge scores than those using other sources. this is probably due to the fact that people who were keen to get more information about the disease actively sought this information from the internet. however, those relying on social media, such as facebook, twitter and whatsapp may have received inaccurate information since social media platforms often lack fact-checking and editorial control [40, 41] . when investigating the knowledge of the participants the major factors were; the educational level, education background, and the field of work (p value within group <0.005 for each) ( table 5 ). this was anticipated and is in line with previous studies that compare the knowledge of the general population about a specific health-related issue with those of higher levels of education or with a health-related backgrounds [42, 43] . the latter would have much better knowledge. comparing the mean knowledge scores of the respondents before and after case reporting (table 2) , showed an improvement in the respondents' knowledge after case reporting (p value between groups <0.05, independent sample t-test). we are aware that differences in the population characteristics before and after case reporting might contribute to observed changes in the knowledge score. however, statistical analysis of the factors affecting participants' knowledge (table 5 ) exhibits that the observed improvement in the knowledge was significant in all the classes of each characteristic (age, gender, marital status, etc, p value between groups <0.05), indicating a palpable effect of case reporting on the participants' knowledge. apparently, people become more interested in learning about a disease when it is seen to be proximal to their vicinity as has been seen in other similar situations [18] . this suggests the importance of pursuing health campaigns and associated recommendations when case reporting of any outbreak or epidemic commences in a country, as the public seems to become more receptive to that additional information. a significant change in the attitudes of participants in many aspects was noticed after reporting cases of covid-19 illnesses in jordan. unexpectedly, the participants seemed to become more optimistic and comfortable after the reporting of cases of covid-19. this optimism appeared in their perception to the severity of disease as a life threatening one, the effectiveness of preventative measures, their ability to protect themselves, the effectiveness of the treatment approaches and the ability of moh to confront the disease. although this is initially puzzling, it can be explained by the unique situation in jordan. shortly after first case reporting in jordan, there was a sense of panic among the population. in order to calm the public and fight the rumors, the first covid-19 patient was interviewed in hospital where he was isolated, by different national and regional tv and radio channels [44] . the patient tried to comfort the people about his situation, since he only suffered from mild respiratory illness. being a traveler returning back from italy, which was hard hit by the pandemic at that time, he compared the looser measures taken by italian authorities to contain the disease with the tougher measures taken in jordan, and he praised the latter. the same thing happened with the second case who only suffered from mild illness. the situation of both patients was of great public interest until they were discharged from hospital. apparently, the message perceived by the public from both patients was that the disease is mild and can be prevented, and that the measures taken by the authorities are effective. our study suggests that the jordanian government's open approach with the public about the disease, its spread, and the necessity for stringent control measures enhanced the optimistic attitudes of the participants towards the disease and its management after case reporting in the country. on the other hand, the attitudes of the participants in other areas remained the same before and after reporting cases in jordan. more than half the respondents indicated their willingness to buy the vaccine (most pharmaceuticals are paid for by the patient in jordan) and the number increased a little more if the vaccine was offered free of charge. these figures are relatively high compared to the general attitudes of jordanians towards vaccinations other than the mandatory ones at childhood [42, 45] . this improved attitude could be related to the worldwide worries about this disease, which have made the jordanians more willing to protect themselves against coronavirus. as for the emergence of this virus, almost half of the participants believed that the virus was created in a laboratory and more than half believed that its emergence was the result of political reason linked to international tension or trade war. this conspiracy theory is not limited to jordanians, and has been reported worldwide. some americans accused china of bioengineering the virus as a bioweapon and conversely, some chinese have accused the american military of introducing it into china. nevertheless, these theories have been refuted in the media and by scientific studies [46] [47] [48] [49] . the practices of the participants in order to prevent the transmission of the virus were found to be adequate for more than two thirds of the respondents. however, there was a remarkable improvement (p < 0.001) in the participants' practices after the reporting of cases of the disease in jordan. the practices evaluated included; avoidance of shaking hands, avoidance of kissing, avoidance of crowded places, and an increase in the use of disinfectants (table 4 ). this improvement in practices' scores was anticipated because the public was observing the disease having increased proximity to their areas, thus they were more willing to engage with the recommendations of the moh regarding covid-19. the improvement in practices' scores seen among the population after case reporting compared to those before case reporting cannot be attributed solely to differences in sample population, because the increase in practice score was obvious in all the population characteristics studied (table 6 ). after reporting cases in jordan, there was a significant decrease in the number of participants using facemasks when going outside. this contradicts the behavior of chinese people during the epidemic in their region, where 98% of a study population indicated wearing facemasks when leaving homes [50] . nevertheless in this respect, the practices of jordanian respondents exhibited better adherence to the instructions of moh at the time. in the early days of the pandemic who and moh instructions to the general public were not to use facemasks, as it was feared this would lead to shortage of masks for essential health and care workers. many other factors affected the overall practices of the respondents. participants with ages of more than 55 years had statistically better practices than those in the lower age groups (18-25yr and 26-35yr; p value within group <0.005). this implies that older respondents are more cautious about their health than younger participants due to who and moh warnings that people above the age of 60 years were at higher risk of developing severe complications than those of younger ages [51] . these findings suggest that the public is willing to implement the recommendations of the health authorities when continuously and firmly directed to do so. surprisingly, the negative factors affecting the overall practices of the participants towards the prevention of transmission are the education level and having a health-related education. these participants scored lower than their counterparts in terms of the best practices (table 6 ). this finding, albeit odd is not uncommon. in a study among health care workers in saudi arabia to evaluate their kap about middle east respiratory syndrome (mers), physicians, pharmacists, nurses and technicians showed low to average scores on practices, but better knowledge and attitude scores [52] . we speculate that having a better education, particularly in a health-related field, provides the participants with confidence that they are aware of the risks and know better how to protect themselves. another disappointing finding is that the overall participants practice score of those working in the health field is the same as those working outside this field (3.9 for each, table 6 ). this finding should be alarming to the health authorities and health care sector, since these workers will be in the front line in combating the epidemic. being lenient in applying the strictest measures and practices in protecting themselves and preventing the spread of infection could lead to a disaster. therefore, the health sector should immediately intensify education and extensive training and setting guidelines for the proper practices among healthcare workers of different specialties. the findings of the study should be interpreted with the following limitations in mind: • sampling of the study was made through social media, what's app in particular, which could pose some bias to the study where underprivileged people or those having problems in using electronic devices may not be able to participate, thus, will be under-represented in the sample. • females and people with education level of more than 12 years were over-represented in the sample studied when compared to the general jordanian population. • like any other self-reported study, responses (mainly of attitudes and practices) could have been reported based on social desirability, not the actual situation of the participants. severe acute respiratory syndrome coronavirus 2 (sars-cov-2) and coronavirus disease-2019 (covid-19): the epidemic and the challenges who [internet]. 2020 centers for disease control and prevention who. events as they happen-rolling updates on coronavirus disease early transmission dynamics in wuhan, china, of novel coronavirus-infected pneumonia novel coronavirus: where we are and what we know coronavirus disease 2019 treatment: a review of early and emerging options draft landscape of covid-19 candidate vaccines modes of transmission of virus causing covid-19: implications for ipc precaution recommendations q&as on covid-19 for older people refugee population by country or territory of asylum-| data health care and pharmacy practice in jordan higher health council & world health organization government suspends educational system in a bouquet of coronavirus preventive measures government announces 10 decisions to fight against coronavirus jordanians now ponder economic cost of coronavirus. in: al-monitor, the pulse of the middle east covid-19) advice for the public bin saeed a. knowledge, attitude and practice of secondary schools and university students toward middle east respiratory syndrome epidemic in saudi arabia: a cross-sectional study covid-19)-how coronavirus spreads covid-19)-how to protect yourself & others. in: centers for disease control and prevention public knowledge, attitudes and practices towards covid-19: a cross-sectional study in attitudes and practices towards covid-19: an epidemiological survey in north-central nigeria sage research methods foundations parental knowledg attitudes and behaviours towards influenza a/h1n1 in italy global patterns in students' views of science and interest in science who says people receiving packages from china not at risk of contracting coronavirus-society & culture-tass los angeles daily news who. coronavirus disease 2019 (covid-19) situation report-43 promotion of appropriate knowledge and attitude towards medicines among schoolchildren in jordan: the role of teachers knowledge and information sources about covid-19 attitudes and behavior regarding antibiotics use and misuse among adults in the community of jordan. a pilot study albsoul-younes am. knowledge, awareness and practices towards seasonal influenza and its vaccine: implications for future vaccination campaigns in jordan. fam pract table 2: estimated population of the kingdom by sex why coronavirus is killing far more men than women-the washington post. the washington post more covid-19 cases, deaths reported in rest of world than in china-who the use of social media among saudi residents for medicines related information internet and social media use for antibiotic-related information seeking: findings from a survey among adult population in italy taking the paper out of news mers-cov infection: mind the public knowledge gap fake news: spread of misinformation about urological conditions on social media the trump effect: with no peer review, how do we know what to really believe on social media? clin colon rectal surg influenza vaccination coverage rates, knowledge, attitudes, and beliefs in jordan: a comprehensive study hepatitis b knowledge, perceptions and practices in the french general population: the room for improvement jordan free from corona cases as infected citizen left quarantine seasonal influenza vaccination among older adults in jordan: prevalence, knowledge, and attitudes. hum vaccines immunother covid-19 coronavirus was not bioengineered. here's the research that debunks that idea covid-19 coronavirus epidemic has a natural origin-sciencedaily coronavirus did not come from a lab: experts debunk myths that china or usa bioengineered covid-19. mail online evolutionary origins of the sars-cov-2 sarbecovirus lineage responsible for the covid-19 pandemic. nat microbiol knowledge, attitudes, and practices towards covid-19 among chinese residents during the rapid rise period of the covid-19 outbreak: a quick online cross-sectional survey who. coronavirus disease 2019 (covid-19) situation report-51 middle east respiratory syndrome (mers): comparing the knowledge, attitude and practices of different health care workers the authors would like to thank professor phillip collier (visiting professor, faculty of pharmacy and medical technology, university of petra) for his critical review of the paper and proof reading. haddadin. the design and timing of this study could not have been more fortuitous, in that it allowed the authors to rapidly adapt and expand a preliminary study into a fully operational before-andafter study of kap towards covid-19. the findings of this study are necessarily complex, but generally show that the population reacts well to open and honest governmental advice about pandemics and can rapidly adopt safe practices in response to appropriate advice. the international relevance of this work is obvious, in that jordan achieved one of the lowest rates (per million population) of covid-19 infection ranking 186 and 177 out of 213 in the number of cases and related fatality respectively, in the world (https://www.worldometers.info/ coronavirus/#countries; 14/08/20). key: cord-011501-o9hmzaxm authors: kühnel, martina b; marchioro, linda; deffner, veronika; bausewein, claudia; seidl, hildegard; siebert, sarah; fegg, martin title: how short is too short? a randomised controlled trial evaluating short-term existential behavioural therapy for informal caregivers of palliative patients date: 2020-04-29 journal: palliat med doi: 10.1177/0269216320911595 sha: doc_id: 11501 cord_uid: o9hmzaxm background: informal caregivers of palliative patients show higher levels of depression and distress compared with the general population. fegg’s (2013) existential behavioural therapy was shortened to two individual 1-h sessions (short-term existential behavioural therapy). aim: testing the effectiveness of sebt on psychological symptoms of informal caregivers in comparison with active control. design: randomised controlled trial. setting/participants: informal caregivers of palliative in-patients. methods: the primary outcome was depression; secondary outcomes were anxiety, subjective distress and minor mental disorders, positive and negative affect, satisfaction with life, quality of life and direct health care costs. general linear mixed models allow several measurements per participant and change over time. reasons for declining the intervention were investigated by rosenstock’s health belief model. results: overall inclusion rate was 41.0%. data of 157 caregivers were available (63.1% females; mean age: 54.6 years, standard deviation (sd): 14.1); 127 participants were included in the main analysis. participation in sebt or active control was not significantly associated with post-treatment depression. outcomes showed prevailingly significant association with time of investigation. self-efficacy, scepticism of benefit of the intervention, belief of better coping alone and support by family and friends were significant factors in declining participation in the randomised controlled trial. conclusion: inclusion rate was tripled compared with a previously evaluated longer ebt group intervention. by shortening the intervention, inclusion rate was traded for effectiveness and the intervention could not impact caregivers’ psychological state. early integration of sebt and combination of individual and group setting and further study of the optimal length for caregiver interventions are suggested. • • informal caregivers of palliative patients are prone to higher levels of depression compared with the general population. informal caregivers are family members and other persons whose support of the patient is not financially rewarded. 1 supporting informal caregivers is an essential part of palliative care, as defined by the world health organization. 2 informal caregivers are prone to higher levels of depression, anxiety, strain and burden than the general population, 3, 4 and the number of interventions to support them is growing. 4, 5 however, a review of caregiver interventions identified a lack of proactive interventions and supposed that caregivers would prefer interventions that improve the ability to care. 6 mindfulness-based interventions for caregivers could potentially close this gap. despite the challenges for caregivers to access interventions due to scheduling difficulties and them having to leave the patient alone, mindfulness showed positive influences on depression, strain and quality of life. 7 fegg et al. 8 developed existential behavioural therapy (ebt), an intervention aimed at informal caregivers of palliative patients. ebt was implemented in a group setting with a total of 22 h focusing on mindfulness practice, strengthening resources, finding meaning, establishing self-care and developing personal values. medium to large effects on anxiety and quality of life and medium effects on depression were demonstrated. a weakness of this study was the low uptake of the intervention with 13.6%. short-term existential behavioural therapy (sebt) aimed to be more compatible with caregivers' daily life. a qualitative study embedded in the fegg study had identified two ebt elements regarded as most helpful by caregivers: social support in the group and self-regulation via strengthening resources and practicing mindfulness. 9 despite the support provided by the group, an individual setting was chosen for sebt to ensure a quicker start of the intervention. to condense ebt for the individual setting, sebt focused on the two elements of self-regulation, shortening it to two 1-h sessions. a feasibility study indicated that sebt was feasible and accepted by caregivers. 10 although sebt is not a treatment applied for a disorder, the term 'therapy' was kept to mark the affiliation with ebt. this study's aim was to evaluate the effectiveness of the sebt intervention in comparison with a usual, nondirective psychological intervention using a randomised controlled trial study design. the primary outcome was informal caregivers' level of depression, as the fegg study had shown long-term effects on depression. secondary outcomes were informal caregivers' levels of anxiety, subjective distress and minor mental disorders, positive and negative affect, satisfaction with life, quality of life and direct health care costs. furthermore, we analysed caregivers' reasons to decline participation in the randomised trial as more research in this field had been suggested. 7 this randomised controlled trial has a parallel-group design with equal 1:1 randomisation and four assessments: pre-treatment, post-treatment and follow-ups after 4 weeks and 6 months. we embedded a follow-up of those informal carers who declined to participate. the study was approved by the ethics committee of ludwig-maximilians-university of munich (no: 545-12) and was registered with clinical.trials.gov (nct02325167). informal caregivers were recruited from the munich university hospital palliative care unit, germany. inclusion criteria were minimum age of 21 years and fluency in german. one caregiver per patient was included, preferably the person closest to the patient. excluded were professional legal representatives and caregivers with severe mental illness (e.g. dementia, acute addiction). the sample size was calculated according to fegg's study: 8 psychotherapy research reports treatment effects between 0.67 and 0.75 standard deviation (sd). 11 to achieve a power of 0.8 at 5% significance level using dupont what this paper adds? • • ebt was shortened to two individual 1-h sessions (sebt) to fit better into caregivers' daily lives. • • this randomised controlled trial tests the effectiveness of sebt on psychological symptoms of informal caregivers in comparison with an active control. implications for practice, theory or policy • • shortening the intervention tripled inclusion rate to 41.0% reaching more caregivers. • • inclusion rate was traded for effectiveness and the intervention could not impact caregivers' psychological state. • • early integration of sebt and combination of individual and group setting are discussed. • • this study's results suggest further study of the optimal length for caregiver interventions. and plummer's 12 sample size calculation and considering a dropout rate of 25%, 55 participants were needed in every arm of the study. caregivers were approached earliest after the day of the patient's admission. they were screened for the inclusion criteria by psychologists with clinical experience. potential participants were contacted in person or by phone and informed orally and in written form about the study. caregivers who did not want to participate were asked to take part in the decliners' follow-up. all participating caregivers and patients provided written informed consent. consent of a legal guardian was sought for patients unable to give consent. immediately after making the first appointment and receiving the first questionnaire, participants were randomised by a randomisation list which was computergenerated with blocks of 10, each containing five control and five sebt assignments in random order. participants were informed about their allocation in the first session. the study was conducted on weekdays between january 2015 and february 2018. recruitment was suspended for 5 months due to staff change (march 2016-august 2016) and three times due to staff vacation ( intervention sebt and control intervention both comprised two sessions in an individual setting lasting 45-60 min; appointments were arranged individually. the interventions took place in a separate room in the palliative care unit and in a psychotherapeutic practice. three psychologists with several years of experience in behavioural psychotherapy were trained using video feedback. sebt and control group sessions were audiotaped and rated for treatment integrity using coding guidelines and checklists (range 0-4: '0' = element missing to '4' = fully consistent with the manual). control group. the active control group was oriented towards carl rogers' 13 client-centred therapy, characterised by acceptance, congruence and empathic understanding, as recommended in supporting informal caregivers in a palliative setting. 14 there was no mention of mindfulness or resources. sebt group. the first sebt session focussing on mindfulness included: introduction, psychoeducation about mindfulness, 2-min body scan, 10-min mindful breathing exercise, addressing questions and motivation to practice mindfulness every day using a cd provided. the second sebt session focussing on resources included: introduction, psychoeducation on psychological meaning of resources, encouragement to express strengthening areas and activities (based on schedule for meaning in life interview 15 ), imaginative exercise of the inner image of the strongest resource addressing all five senses, choice of a symbol as reminder and prime, addressing questions, motivation to practice mindful breathing and imaginative exercise using the cd. caregivers' demographic data and patients' medical data were collected through self-report and clinic chart review. participants of the randomised controlled trial completed standardised questionnaires at the time of study entry (t1), after the second intervention session (t2) and 4 weeks (t3) and 6 months (t4) after the second intervention session. participants of the decliners' follow-up received three questionnaires: at t1 and follow-ups 4 weeks (t3) and 6 months (t4) after t1, with no decliner questionnaire at t2. all measurement instruments were used in a validated german version. primary outcome. level of depression was measured with patient health questionnaire, 9 items; a score >15 is associated with clinical levels of depression, and scores are sums ranging from 0 to 27. 16, 17 secondary outcomes. generalised anxiety disorder was assessed using the generalised anxiety disorder questionnaire, 7 items; a score >10 indicates general anxiety disorder, and scores are sums ranging from 0 to 21. 18, 19 subjective distress was measured using the national comprehensive cancer network's distress thermometer; a score >5 indicates a clinically relevant level of distress, scale range 0-10, from 'no distress' to 'extreme distress'. 20 minor mental disorders were assessed using the general health questionnaire, 12 items, with higher scores indicating higher level of mental disorder; scores are sums of item values ranging from 0 to 36. 21, 22 positive and negative affect were measured using the positive and negative affect schedule, with higher scores indicating higher levels of affect; scores ranging from 1 to 5 are means of positive and negative items, respectively. 23, 24 life satisfaction was measured using the satisfaction with life scale, with higher scores indicating higher degree of satisfaction; scores are sums of item values ranging from 0 to 36. 25, 26 quality of life was assessed using the world health organization quality of life questionnaire, abbreviated version: scores range from 0 to 100, with higher scores denoting higher quality of life; scores were built according to the manual guidelines, including handling of missing data. 27, 28 health-related resource use of the past 6 months (number of physician contacts, physiotherapist contacts, hospital days, and rehabilitation days) was collected using the german questionnaire for health-related resource use in an elderly population (at t1 and t4). 29 individual costs were added up after assigning a cost to each component based on unit prices published by bock et al. 30 three numerical rating scales with one item each measured quality of life, physical impairment and psychological impairment, with scores ranging from 0 to 10, with higher scores indicating higher levels. of all the used scales, only in the manual of the world health organization quality of life questionnaire, 27,28 guidelines on how to treat missing data were provided: outcomes were only computed if at least 80% of the items in a scale were available and the missing items were imputed with the mean of the available items. otherwise the whole observation was discarded. for consistency, we applied this approach to all scales. belief model, designed to predict health-promoting behaviour, was employed in order to understand reasons for declining. 31, 32 the following four factors of the health belief model each comprised several variables and were included in questionnaires for decliners and for the randomised controlled trial. 'modifying factors': age, gender, knowledge about depression (numerical rating scale ranging from 0 to 10) and self-efficacy (german general self-efficacy short scale) scores are means ranging from 1 to 5, with higher scores indicating higher levels. 33 factor 'perceived susceptibility and severity': two numerical rating scales with 0-10 ranges on susceptibility for and severity of suffering from depression. factor 'perceived benefits and barriers': four numerical rating scales on scepticism of benefit of the intervention (adapted from patient questionnaire on therapy expectation and evaluation, 34 1-5 range), belief in benefit (adapted from german questionnaire for measurement of psychotherapy motivation, 35 1-5 range), belief one should cope alone (adapted from german questionnaire for psychotherapy motivation, 36 1-4 range), and belief that the intervention benefit would be greater than the costs (1-4 range). higher scores indicate higher agreement. factor 'cues to action': three numerical rating scales on advice from family/friends to accept psychological support, the extent of support by family/friends and the quality of the relationship with the patient, with higher scores indicating higher levels. changes in the outcomes over time were evaluated via general linear mixed model with random intercept for subjects. these models allowed several measurements per participant and change over time. a separate regression model was built for each outcome measure. outcomes from all three post-treatment questionnaires (t2, t3, t4) were dependent variables. variables 'group' (sebt or control group) and 'time of investigation' were independent variables. the interaction effect between 'group' and 'time of investigation' was only included if significantly different from zero. the pre-treatment (t1) value of each outcome measure was included as a predictor variable, capturing individual status before the treatment. in all models, we controlled for age, gender, relationship with the patient (patient is partner/child vs other); patient's time of death (patient alive, unknown, deceased >3 months before measurement, <3 months before measurement); employment (employed/student vs retired/unemployed); the psychologist delivering the intervention (psychologist 1, 2 or 3); and other support used (e.g. social worker, pastoral care, other psychologist; yes, no or unknown). besides the main model (model 1), we conducted sensitivity analyses considering the following two subgroups of the study population: only participants (sebt or control group) who attended both interventional sessions (model 2) and all control participants and only sebt participants who had practised mindfulness at least once using the cd (model 3). sensitivity analyses controlling for missing data were also conducted. data were analysed according to the principle 'full analysis set' which is as complete and as close as possible to the intention to treat ideal of including all randomised subjects. 37 the regression analyses included only individuals with at least one intervention session and participation in the investigations before (t1) and after the intervention (t2). a binary logistic regression was conducted to investigate which factors led to declining or accepting the intervention. based on rosenstock's 31 health belief model, stepwise inclusion of four factors emulated the process of decision-making for or against the intervention. an overall result was deduced from all four steps. in addition, linear mixed models with repeated measurements were used to model all outcome parameters at t1, t3 and t4 in order to detect differences in outcomes between the participants of the randomised controlled trial and the decliner participants. to analyse differences in direct health care costs, the non-parametric mann-whitney u test was used due to skewed distribution of the data. statistical analyses were performed using ibm spss statistics v.25; a value of p < 0.05 was considered significant; a value of p < 0.1 was considered a trend. results are reported following the consort statement. out of 722 potential participants, 227 were excluded during recruitment (31.4%; see figure 1 ), hence 495 caregivers were contacted (68.6%). of these, 67 participated in the decliners' follow-up and 225 declined any participation. a total of 203 caregivers were randomised into the sebt or the control group; the inclusion rate was 41.0%. during the study, 10 cases were excluded as they had been wrongfully assigned. after the randomisation, 36 participants dropped out before t1 (20 sebt, 16 controls). in total, 157 participants of the randomised controlled trial took part in the pre-intervention examination (t1). at t1, sebt and control participants showed no significantly different characteristics (see table 1 ). the mean age was 54.6 years (sd 14.1) and most participants were female (63.1%). more than one-third of the participants held a university degree (38.2%), more than half were married (59.2%); nearly one-third was retired (29.9%) and twothirds employed (full time 42.7%, part time 22.0%). participants were mostly either patients' partners (including wives or husbands; 39.5%) or their children (36.9%). cancer was the prevailing diagnosis of the patients (79.5%). two-thirds of participants received interventions by psychologist 3 (66.2%). most patients were alive at t1 (84.7%; 7.0% deceased ⩽3 months ago; 8.3% unknown; n = 157). at t2, patients were mostly alive (49.6%) or had deceased during the last 3 months (43.3%; 7.1% unknown; n = 127). at t3, most patients had deceased during the last 3 months (73.7%; 17.2% alive; 4.1% deceased >3 months ago; 4.9% unknown; n = 122), and at t4, most patients had a due to missing data at t2, participants' datasets were excluded from analyses. b despite missing data at t3, participants' datasets were included in analyses. thirty participants of the pre-intervention examination (t1) were not included in the main data analysis because they dropped out during the intervention or had missing data at t2 (see figure 1 ). an independent-sample t-test indicated that these drop-outs had higher levels of negative affect at t1 (mean: 2.58, sd: 0.61) than participants included in the main analysis (mean: 2.22, sd: 0.68; p-value: 0.010), and they tend to higher levels of minor mental disorders (mean: 1.48, sd: 0.46) than participants included in the main analysis (mean: 1.30, sd: 0.45; p-value: 0.058; unequal variances). they did not significantly differ in any other outcome or characteristic. a total of 127 participants were included in the main regression analysis (model 1) according to the principle of 'full analysis set' as they participated in at least the first two investigations at t1 and t2. these participants showed mild and subclinical levels of depression at t1 (mean: 8.79, sd: 5.20). the sample's average score on anxiety was just under the cut-off for clinically relevant levels (mean: 9.69, sd: 4.77). their average level of distress was above the score indicating clinical relevance (mean: 7.50, sd: 2.00). at t3, 122 datasets were available and included in analyses. at t4, 118 datasets were available and included. the percentage of scales with at least one missing item was 7.49%. by including observations which had at least 80% of items completed, we were able to lower the number of scales that had to be discarded to 3.74%. in total, 291 intervention sessions were held (sebt and control, including dropouts), 29 participants received only one session. 274 audiotapes of the intervention sessions were available (94.2%), eight were incomplete and not rated; five participants declined consent for audiotaping. 266 audiotapes were rated to evaluate treatment integrity. the therapists' adherence to the intervention manual was high (sebt mean: 3.80, sd: 0.36; control mean: 3.87, sd: 0.33). the level of depression did not differ significantly between sebt and control group (sebt beta: -.147; control group as reference category); this was true for all three models (see table 2 ). apart from the impact of pre-treatment depression, there was a trend for the time of investigation being associated with the post-treatment depression level (t3 beta: -.796; t4 beta: -1.32; t2 as reference category), as depression was on average lower at t3 and t4 than at t2. the interaction effect between the group and the time of investigation was not included in the main model since it was not significantly different from zero. according to the results of the main models, all posttreatment secondary outcomes did not significantly differ between sebt and control group (for tables see supplemental material appendix b). the interaction effect between the group (sebt/control) and the time of investigation was not included in the main models as it was not significantly different from zero, except for psychological impairment. time of investigation was significantly associated with outcomes anxiety (t3 beta: -1.21; t4 beta: -1.67; t2 as reference category), positive affect (t3 beta: .158; t4 beta: .290) and minor mental disorders (t3 beta: .1.32; t4 beta: 2.96), and was associated by trend with negative affect (t3 beta: .127; t4 beta: .165) and quality of life (numerical rating scale; t3 beta: .444; t4 beta: .574). patients' time of death was significantly associated with outcomes negative affect (alive beta: .066; deceased >3 months ago beta: -.289; time of death unknown beta: .086; deceased ⩽3 months ago as reference category), satisfaction with life (alive beta: -1.38; deceased >3 months ago beta: .984; time of death unknown beta: -1.70), subjective distress (alive beta: .424; deceased >3 months ago beta: -1.13; time of death unknown beta: .360) and psychological impairment (alive beta: .615; deceased >3 months ago beta: .456; time of death unknown beta: 1.83); patients' time of death showed a trend to be associated with anxiety (alive beta: .011; deceased >3 months ago beta: -1.55; time of death unknown beta: .982). relationship with the patient was significantly associated with quality of life (numerical rating scale; partner/child beta: -.680; other relationship as reference category). age showed a trend to be associated with subjective distress (beta: .033) and gender showed a trend to be associated with psychological impairment (male beta: -.613 female gender as reference category). in addition, we conducted sensitivity analyses regarding missing data (for tables see supplemental material appendix c). participants without missing items in any of the relevant outcome scales were regarded as having no missing data (n = 45, 35.4%); they were significantly younger than participants with missing data (n = 82). a variable discriminating between these two groups was added to an additional set of regression analyses. these analyses yielded highly similar results compared the analyses described above, apart from the variable missing data being associated by trend with negative affect (no missing data beta: .155). at t1, a mann-whitney u test showed that, at t1, there was no significant difference between the median of direct health care costs for the past 6 months of sebt participants (median: €450, n = 51, interquartile range: 846.4) and controls (median: €328, n = 62, interquartile range: 558.8). at t4, there was also no significant difference between the median of direct health care costs for the previous 6 months of sebt participants (median: €224, n = 54, interquartile range: 560.2) and controls (median: €301, n = 64, interquartile range: 829.9). data of 50 decliners were available at t1, as 17 dropped out before t1. data of 43 decliners were available for the follow-up at t3 and data of 38 decliners at t4. declining participants were significantly older (mean: 60.9 years, sd: 13.1) than participants of the randomised controlled trial (mean: 54.6, sd: 14.1) but did not significantly differ regarding gender, relationship status or employment. linear mixed models with repeated measurements modelling all outcome parameters at t1, t3 and t4 showed no differences in any outcomes between the participants of the randomised controlled trial and the decliner participants. the binary logistic regression showed that the preference towards the decliner study significantly depends on 'perceived benefit and barriers' and 'cues to action' (see table 3 ). the odds to prefer the decliners' follow-up were 2.45 times higher for caregivers with high self-efficacy (95% confidence interval: 1.06-5.65), 1.71 times higher when being sceptic of the benefit of the intervention (95% confidence interval: 1.12-2.61), 2.21 times higher for caregivers who believed in better coping alone (95% confidence interval: 1.28-3.81) and 1.30 times higher for caregivers supported by family and friends (95% confidence interval 1.01-1.69). the purpose of sebt is to provide a short-term intervention with coping strategies to informal caregivers of palliative patients facing the existential situation of disease and bereavement. this randomised controlled trial studied the impact of sebt on depression, anxiety, subjective distress, minor mental disorders, positive and negative affect, satisfaction with life, quality of life and direct health care costs. receiving sebt sessions or supportive psychological sessions was neither significantly associated with the primary outcome of post-treatment depression nor with the secondary outcomes. the outcomes were prevailingly associated with their respective level before the intervention and with the time of investigation, which leads to the assumption that the time passing was the main reason for changes of outcomes over the course of 6 months. caregivers who declined the intervention did not differ significantly from participants of the randomised controlled trial in outcomes at any assessment. in fegg et al'.s 8 randomised controlled trial on ebt, the control participants did not receive a control treatment and instead could decline any support or could choose from the spectrum of available support at the palliative care unit (e.g. physicians, nurses, chaplains, social workers, psychologists and bereavement group), whereas this study included an active control group. it is possible that sebt and control showed no significant difference as both groups received a treatment of similar effectiveness. palliative caregivers' capacities for learning new skills like mindfulness might be limited: they face high emotional distress and the responsibilities palliative caregivers typically take over for the patient (i.e. financial decisions, organisation of follow-up hospice care) additionally to their own duties. fegg et al'.s 8 study provided a group setting which could have facilitated learning the new skill of mindfulness by benefitting from group cohesion, central for beneficial effects in group therapy 38, 39 or by relieving participants from the personal responsibility to practice. participants in sebt were asked to practice mindfulness by themselves which was possibly too demanding, leading to low compliance to practice and less effectiveness. our aim was to create a short-term ebt intervention that fitted better into informal caregivers' daily lives. we reached our goal of increasing acceptability: 41.0% of all contacted caregivers participated in the randomised controlled trial. shortening ebt and choosing an individual setting tripled the inclusion rate compared with 13.6% in fegg et al'.s 8 study. however, by shortening the intervention, we traded inclusion rate for effectiveness and the intervention was not intensive enough to impact caregivers' psychological state in comparison to the control group. carmody and baer's 40 review about the optimal length of mindfulness based programmes, with participants ranging from healthy to chronically ill participants, did not evidence that shortened versions of mindfulness-based programmes are less effective compared with the standard format of 26 class hours. the authors suggested that adaptations including less class time may be worthwhile for populations for whom a longer time commitment may be a barrier to participate. but how short is too short? the study with the fewest sessions in carmody and baer's 40 review included 6-weekly 1-h classes, 41 which is three times more instruction time than in this study. our results lead to the conclusion that the 2-h sebt version is too short, especially with participants as burdened as palliative caregivers. the optimal length of mindfulness-based interventions for informal caregivers should be investigated further to offer interventions which impact caregivers' psychological status while not overwhelming them. strengths of the study include the randomised controlled design, the high adherence of the therapists to the manual and the embedded decliners' follow-ups which allowed a comparison with trial participants and ensured high external validity. during the study, it became apparent that 10 participants had been assigned to sebt or control group violating the randomisation protocol. recruiting was suspended, all data collected up to this point was carefully checked and affected participants' data were excluded from analysis. in addition, appropriate measures of staff change and staff training were taken. data of 30 caregivers were removed from analysis as they had missing post-intervention data at t2 or dropped out of the intervention. comparing their pre-intervention data to the other participants, they had higher levels of negative affect and of minor mental disorders which possibly caused them to drop out. this leads to the assumption that the intervention might be too demanding for highly burdened caregivers. profiting of the 'small window' 6 for recruiting caregivers before they become too burdened by care could be facilitated with early integration of palliative care. 42, 43 early integration of sebt could help caregivers learn new skills to prepare for stressful times ahead. furthermore, sebt could benefit from mixing the settings. sörensen et al. 44 suggested combining group and individual setting to improve caregiver affect in the individual setting and help build social networks in the group. individual sebt could offer immediate support to caregivers, while a following ebt group could yield higher impact on caregivers' psychological morbidity with more class hours and positive influence of group cohesion 38 on motivation and personal practice. ethical approval precludes the data being provided to researchers who have not signed the appropriate confidentiality agreement. these restrictions are as per the ethics committee of ludwig-maximilians university munich which approved the study . in accordance with ethical approval, all results are in aggregated form to maintain confidentiality and privacy. data are held at the department of palliative medicine, munich university hospital, ludwig-maximilians-university, munich, germany. the author(s) declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article. the author(s) disclosed receipt of the following financial support for the research, authorship and/or publication of this article: stifterverband für die deutsche wissenschaft e.v. (h420 7218 9999 25214). martina b kühnel https://orcid.org/0000-0001-5942-8915 supplemental material for this article is available online. eapc task force on family carers white paper on improving support for family carers in palliative care: part 2 a psychoeducational intervention for family caregivers of patients receiving palliative care: a randomized controlled trial the psychological impact of cancer on patients' partners and other key relatives: a review a meta-analytic review of interventions for caregiver distress: recommendations for future research supporting lay carers in end of life care: current gaps and future priorities evaluating the effects of mindfulness-based interventions for informal palliative caregivers: a systematic literature review existential behavioural therapy for informal caregivers of palliative patients: a randomised controlled trial determinants of the effect of existential behavioral therapy for bereaved partners: a qualitative study the feasibility and acceptability of short-term, individual existential behavioural therapy for informal caregivers of patients recruited in a specialist palliative care unit the efficacy of psychological, educational, and behavioral treatment: confirmation from meta-analysis power and sample size calculations: a review and computer program counseling and psychotherapy; newer concepts in practice psychologie und palliative care: aufgaben, konzepte und interventionen in der begleitung von patienten und angehörigen the schedule for meaning in life evaluation (smile): validation of a new instrument for meaning-in-life research the phq-9: validity of a brief depression severity measure screening psychischer störungen mit dem 'gesundheitsfragebogen für patienten (phq-d) a brief measure for assessing generalized anxiety disorder: the gad-7 psychometric evaluation of the generalized anxiety disorder screener gad-7, based on a large german general population sample die deutsche version des nccn distress-thermometers a user's guide to the general health questionnaire psychometric properties of the general health questionnaire (ghq-12) in a german primary care sample development and validation of the brief measures of positive and negative affect: the panas scales untersuchungen mit einer deutschen version der 'positive and negative affect schedule'(panas) the satisfaction with life scale the german version of the satisfaction with life scale (swls): psychometric properties, validity, and population-based norms development of the world health organization whoqol-bref quality of life assessment whoqol-100 und whoqol-bref -handbuch für die deutschsprachigen versionen der who instrumente zur erfassung von lebensqualität fima -questionnaire for health-related resource use in an elderly population: development and pilot study calculation of standardised unit costs from a societal perspective for health economic evaluation why people use health services evaluating the effectiveness of health belief model interventions in improving adherence: a systematic review kurzskala zur erfassung allgemeiner selbstwirksamkeitserwartungen (asku) messung der therapieerwartung und therapieevaluation von patienten (pathev) fragebogen zur messung der psychotherapiemotivation (fmp) fragebogen zur psychotherapiemotivation (fptm) -testkonstruktion und gütekriterien statistical principles for clinical trials (ich e9): an introductory note on an international guideline clinical practice guidelines for group psychotherapy a systematic review of therapeutic alliance, group cohesion, empathy, and goal consensus/collaboration in psychotherapeutic interventions in cancer: uncommon factors how long does a mindfulnessbased stress reduction program need to be? a review of class contact hours and effect sizes for psychological distress effects of lowdose mindfulness-based stress reduction (mbsr-ld) on working adults early palliative care for patients with advanced cancer: a cluster-randomised controlled trial integration of palliative care into standard oncology care: asco clinical practice guideline update summary how effective are interventions with caregivers? an updated meta-analysis we thank all caregivers, patients and staff members especially verena zierl, marianne schmidt and sigrid haarmann-doetkotte for their contribution to this study. key: cord-253556-p1y0zeo1 authors: rhodes, scott d.; mann-jackson, lilli; alonzo, jorge; garcia, manuel; tanner, amanda e.; smart, benjamin d.; horridge, danielle n.; dam, cornelius n. van; wilkin, aimee m. title: a rapid qualitative assessment of the impact of the covid-19 pandemic on a racially/ethnically diverse sample of gay, bisexual, and other men who have sex with men living with hiv in the us south date: 2020-08-12 journal: res sq doi: 10.21203/rs.3.rs-57507/v1 sha: doc_id: 253556 cord_uid: p1y0zeo1 persons living with hiv (plwh) may be at increased risk for severe covid-19-related illness. our community-based participatory research partnership collected and analyzed semi-structured interview data to understand the early impact of the covid-19 pandemic on a sample of racially/ethnically diverse gay, bisexual, and other men who have sex with men living with hiv. fifteen cisgender men participated; their mean age was 28. six participants were black/african american, five were spanish-speaking latinx, and four were white. seventeen themes emerged that were categorized into six domains: knowledge and perceptions of covid-19; covid-19 information sources and perceptions of trustworthiness; impact of covid-19 on behaviors, health, and social determinants of health; and general covid-19-related concerns. interventions are needed to ensure that plwh have updated information and adhere to medication regimens, and to reduce the impact of covid-19 on social isolation, economic stability, healthcare access, and other social determinants of health within this vulnerable population. the united states (u.s.) south continues to experience disproportionate hiv rates compared to other regions of the country and has been referred to as the "new" and "latest" u.s. hiv epicenter (1, 2) . southern states account for an estimated 51% of new hiv diagnoses in the u.s. each year, despite having only 38% of the county's overall population. eight of the 10 states with the highest rates of new hiv diagnoses, and nine of the 10 metropolitan statistical areas with the highest rates, are in the south (2) . north carolina (nc) consistently ranks among these top 10 states for hiv diagnoses (3) , and guilford county, located in the piedmont triad region of central nc, has consistently higher rates of hiv than nc and the u.s. overall (4, 5) . guilford county ranks third out of the 100 counties in the state for hiv per 100,000, and its hiv incidence rate is 50% higher than the national rate (6) . coronavirus disease 2019 (covid-19) is a new infectious disease caused by the novel severe acute respiratory syndrome coronavirus 2 (sars-cov-2), which had not previously been reported in humans (7) . manifestations range from asymptomatic infection to severe complications including pneumonia, acute respiratory distress syndrome, coagulopathies, immune system dysregulation, and death. covid-19 is highly contagious and has quickly spread globally. (8, 9) the rst case of covid-19 in nc was identi ed on march 3, 2020, and on march 10, nc declared a state of emergency (10) . given the ongoing rise in community-acquired covid-19 cases in nc, on march 30, a statewide stay-at-home order went into effect that limited activities to those that were considered essential (e.g., health-, safety-, nutrition-, and sanitation-related), banned gatherings of more than ten people, and prioritized social distancing (staying at least 6 feet away from other people) (11) . the nc stay-at-home order was eased on may 8, 2020, with a phased re-opening that continued to limit the types of businesses and institutions that could open and the sizes of gatherings. hiv infection, along with several other immunosuppressing conditions, might increase risk of severe covid-19-related illness (12) . although the underlying mechanism is not fully understood, this risk for plwh may be due to a reduction in lymphocytes, immune system dysregulation, or an increased in ammatory response (13) . comorbidities that are becoming increasingly common among plwh, such as diabetes, chronic kidney disease, chronic obstructive pulmonary disease, and obesity, also increase the risk of developing severe illness from covid-19 (14) . the burden of these risks may not be carried equally among all plwh. communities of color face disproportionate rates of hiv, and black/african american gay, bisexual, and other men who have sex with men (gbmsm) and black/african american transgender women have higher rates of hiv than any other group in the us (15, 16) . in addition, black/african american and latinx plwh have lower rates of care linkage and retention and are less likely to be virally suppressed than white plwh (17) . in addition, persons of color are also experiencing disparities related to covid-19. as of june 2020, black/african american and native american or alaska native persons have covid-19-related hospitalization rates ve times that of non-hispanic white persons, and hispanic or latinx persons have covid-19 diagnosis rates four times those of non-hispanic white persons (18) . these higher rates may be related to living conditions, work circumstances, and health disparities including insurance and healthcare access as well as higher rates of comorbidities that increase the risk of severe illness from covid-19, which are shaped by the larger context of systemic racism and inequalities (16, 19) . therefore, racially/ethnically diverse gbmsm living with hiv are a particularly vulnerable population when considering the risk and impact of covid-19. despite the impact of covid-19 and potential for serious morbidity and mortality, little is known about the pandemic from the perspective of plwh themselves. our long-standing community-based participatory research (cbpr) partnership sought to qualitatively explore the impact of the covid-19 pandemic within a racially/ethnically diverse sample of gbmsm living with hiv. this rapid assessment was conducted by our cbpr partnership in nc that includes racially/ethnically diverse gbmsm living with hiv; representatives from public health departments, hiv service organizations, and clinics that serve plwh; and academic investigators. this partnership has an established history exploring and intervening on the health-related needs and priorities of vulnerable communities (5, (20) (21) (22) . we collected qualitative data from participants who had completed 12 months of participation in and had "graduated" from the wecare intervention. wecare is an evidence-informed intervention that improves hiv care engagement among racially/ethnically diverse gbmsm and transgender women living with hiv by reducing missed hiv care appointments and increasing viral suppression (21, 23, 24) . wecare currently is being conducted in partnership with the regional center for infectious diseases (rcid) in guilford county, nc (21) . rcid is funded by the ryan white hiv/aids program, health resources and services administration (hrsa), to serve low-income plwh who are uninsured or underinsured. rcid provides comprehensive integrated services for plwh, including hiv primary medical care, case management, bridge counseling, nancial assistance, behavioral health care, community outreach nursing, and a dental clinic. the details of the wecare intervention are described elsewhere (21, 23, 24) ; brie y, wecare harnesses social media platforms, including facebook messenger, text messaging (including through applications or "apps" such as whatsapp), and messaging through gps-based mobile apps used for social and sexual networking (e.g., a4a/radar, badoo, grindr, jack'd, and scruff) to improve linkage to and retention in hiv care among plwh. the intervention is targeted to racially/ethnically diverse gbmsm and transgender women living with hiv, tailored to the social media platform preferences of participants, and personalized to each participant's needs (23) . eligibility criteria to participate in wecare include: being age 16 or older, identifying as cisgender male or male-to-female transgender, reporting sex with men, and living with hiv. potential participants are referred to the study by clinic and health department staff. we also advertise the intervention study on facebook through paid targeted advertisements and on other social media platforms, in a southeastern lgbtq (lesbian, gay, bisexual, transgender, and queer) newspaper, and through yers posted within bars, clubs, and coffee shops. furthermore, we recruit participants through word-of-mouth; enrolled participants are encouraged to share information about the study with others in their social networks. if eligible and interested, participants complete written informed consent procedures and enroll. participation in the intervention lasts 12 months, after which participants graduate from wecare. of the graduated wecare participants, we randomly selected and contacted 15 of them to complete an interviewer-administered semi-structured individual interview. the abbreviated interview guide is outlined in table i . demographic questions included some close-ended items; however, most questions in the interview guide were open-ended to allow participants to describe their experiences, perceptions, and attitudes. a trained bilingual interviewer conducted the interviews in english and spanish via telephone between april 23 and may 23, 2020. interviews were recorded and professionally transcribed. constant comparison, an approach to grounded theory, was used to analyze data. constant comparison combines qualitative coding with simultaneous comparison; initial observations are continually re ned throughout data collection and analysis (25). because of the formative nature of this study, we aimed to identify the breadth of experiences, not to quantify them. analysts coded transcripts and developed matrices to identify similarities and differences within and across interviews. based on these matrices, each analyst developed preliminary themes. after preliminary themes were developed, the analysts came together via webex (a web-conferencing platform) to discuss and reconcile nal themes. human subject approval and oversight was provided by wake forest school of medicine institutional review board (irb). fifteen racially/ethnically diverse cisgender men participated; no participants refused to participate. participant mean age was 28. six participants were black/african american, ve were latinx, and four were white; all latinx participants completed their interviews in spanish. one participant self-identi ed as bisexual; all others self-identi ed as gay. eleven participants self-reported being virally suppressed while four reported not knowing whether they were virally suppressed. table ii . participants knew a great deal about covid-19 and its transmission. they were aware of recommended precautions to prevent infection, including wearing a face covering, social distancing, and handwashing. many were aware of the nc stay-at-home order that was in effect at the time of the interview and reported adhering to the order. for example, a participant reported, it's contagious. it affects the respiratory system. it can be fatal in some cases, but some people get through. it's important to take precautions and stay at home like the governor says. (participant [p]13, black/african american, 26 years old) another participant noted, "es un virus muy contagioso, que se transmite de una persona enferma si está muy cerca cuando tose. también, si la persona enferma toca algo, y la persona sana toca la misma super cie, se puede contagiar." ["it is a very contagious virus that is transmitted from a sick person if they are very close when they cough. also, if the sick person touches something, and the healthy person touches the same surface, it can be contagious."] (p4, latinx, 35 years old) covid-19 is perceived as serious, and participants perceive themselves to be susceptible participants reported that covid-19 was serious and that those with compromised immune systems were especially at risk. they were worried about their own increased risks as plwh and noted that hearing about others who had similar characteristics to them being seriously affected also increased their concerns. a participant stated, creo que es muy serio porque nunca en mi vida había visto algo así. afecta a las personas que tienen el sistema inmunológico comprometido como personas con diabetes o con problemas respiratorios, así que es muy serio. uno piensa que porque uno es joven no le va a pasar, pero estamos viendo casos de jóvenes que han muerto por este virus y eso lo hace más grave para mí. [i think it is very serious because i have never seen anything like this in my life. it affects people who have compromised immune systems like people with diabetes or respiratory problems, so it's very serious. you think that because you are young it will not happen to you, but we are seeing cases of young people who have died from this virus and that makes it more serious for me.] (p3, latinx, 28 years old) another participant said, "the coronavirus is making me super cautious. i am just afraid to contract it so i think about it a lot, but i try to stay optimistic about the entire situation." (p14, black/african american, 27 years old) participants also reported worrying about the well-being of friends and family members, particularly those who were older, had comorbidities, or had other risk factors for developing serious illness from covid-19. a participant noted, "pues, estoy muy preocupado por toda mi familia y mi círculo porque no solo me puede afectar a mí, sino a toda mi familia también. participants found available and prevailing information regarding the transmission and prevention of covid-19 to be con icting. social media (e.g., facebook), the internet (e.g., cdc website), and television (e.g., english-and spanishlanguage national and local news) were noted as places that participants obtained information about covid-19. participants also reported that they received information from their workplaces, as guidelines and regulations changed and thus required changes to how work was performed. for example, participants who worked in restaurants noted that they learned about transmission, prevention, and the current state of disease burden from restaurant owners and managers. in addition, participants described friends and family as sources of information about covid-19. a participant reported, "i get info on tv, and i did some research on the internet, read some articles, and heard some through word-of-mouth, like during a meeting at work when we go over protocols and changes that are going into effect because of the coronavirus." (p10, white, 28 years old) another participant agreed saying, "i honestly do not trust anything that the president says." (p14, black/african american, 27 years old) a third participant stated, "no confío mucho porque creo que no le tomaron mucha importancia cuando empezó y por eso estamos con estos números tan altos." ["i do not trust much, because i think they did not take it seriously when it started and that is why we have these high numbers."] (p4, latinx, 35 years old) healthcare providers, including hiv providers, were identi ed in particular as providing timely and trustworthy information about covid-19. a participant stated, "i trust my doctor, especially because i believe they have the best interest at heart and they are the people on the frontline. they are telling us what they understand and what they are seeing from their patients." (p7, black/african american, 23 years old) participants are taking action to reduce their risks participants reported staying home, maintaining social distancing, and cleaning with disinfectants and sanitizers to prevent contracting covid-19. a participant commented, "i have not been out. today is actually the rst time i went out to go to the store. no hugging anyone; i try to stay away from people as much possible or at least six feet." (p6, black/african american, 21 years old) this commitment to prevention was noted by other participants. for instance, a participant stated, "i have been extremely social distancing. i, in fact, haven't left my house; some of my friends do the grocery shopping for me and leave my groceries by the door. i bring them inside, sanitize them, and throw the bags out." (p7, black/african american, 23 years old) further, another participant noted, "guardo mi distancia entre las personas cuando salgo a la tienda, uso desinfectante de alcohol en mis manos, mascarilla cuando salgo afuera, y limpio con desinfectante las áreas que más toco como el refrigerador, las llaves, mi tarjeta de débito, y las mancillas de la puerta." ["i keep my distance from people when i go out to the store, use alcohol disinfectant on my hands, a mask when i go outside, and clean the areas i touch the most with disinfectant, such as the refrigerator, keys, my debit card, and the door handles."] (p3, latinx, 28 years old) participants noted that worries and fears related to covid-19 and behavioral changes that they are making to stay safe are affecting them in both negative and positive ways. a participant noted that he is sleeping less because he is worried about his health, the health and well-being of his friends and family, and the long-term impact of the pandemic locally and globally, reporting, "my sleeping schedule has been changing a lot. it is hard to sleep 8 hours as i used to." (p8, black/african american, 21 years old). another participant commented, "i am working out less to avoid public settings." (p9, white, 23 years old) however, some participants reported positive changes they had made in their health behaviors as a result of staying home and other adaptations related to covid-19 prevention. a participant noted, "i stopped drinking alcohol because i gure that i have bad habits when i am at home alone; because in the rst week or so of the stay home order for the coronavirus, i was drinking a lot and that kind of hurt me." (p11, white, 25 years old). further, another participant shared, "i actually started meditating in the mornings so i can have a good set of mind about all this. and i have been spending more time in the backyard and gardening more than i did before." (p15, white, 27 year old) before the initiation of the covid-19 pandemic, participants were already communicating frequently through social media platforms such as facebook, texting, and gps-based mobile apps. after the pandemic began, however, participants reported increased use of these types of social media platforms. a participant noted, "i use facebook much more now because it is the only way we have to communicate with other people." (p12, black/african american, 21 years old) use of other technology for communication, such as video calls, also increased, as another participant added, "i don't see my friends and family much now, and if i do, we try to facetime on the iphone or call each other on facebook to see them on video. we talk on the phone to catch up. that is the only way we do it to be safe and cautious." (p10, white, 23 years old) participants reported that their mental health was profoundly affected by covid-19 and the necessary precautions required to reduce risks of exposure. a participant noted, "the changes make me feel hopeless and sad. i am just realizing that everyone wants things to go back to normal, but i think a lot of things will change, and lots of polices that are in place will change, like in restaurants and bars. it will never be normal." (p7, black/african american, 23 years old) another participant reported, "i do feel alone, and it kind of reminds me of when i learned that i had hiv." (p15, white, 27 years old) accessing medical care is more di cult participants reported that accessing medical care had become more di cult in the context of covid-19. though as of the time of data collection participants had not experienced interruptions in their hiv care, some had not been able to get other needed care. as a participant reported, "it [covid-19] just makes things harder. i was not able to go to the dentist to take out my wisdom teeth because they do not do anything that is not a priority." (p6, black/african american, 21 years old). participants had also had challenges with virtual appointments (e.g., telemedicine). for example, a participant shared, "for the follow-up appointment i had to see the doctor through zoom, but he couldn't really see me and that made things more challenging, especially because the technology wasn't really working. things are more complicated now." (p14, black/african american, 27 years old) overall, participants reported obtaining hiv medications as needed since the initiation of the pandemic. however, they did report that adhering to medication regimens had become more di cult. a participant shared, "it's been easy to get the medications because the pharmacy sends them, but it has been challenging to take them as i should because i had a routine before. i used to take my medication every day at work, but since i am working from home, i can't follow the same routine." (p15, white, 27 years old) participants reported multiple ways in which covid-19 affected them through social determinants of health. first, some participants noted that they had lost educational opportunities. a participant reported, "i was supposed to have an internship this summer and make money. it's been very stressful, and i am not having a good summer." (p6, black/african american, 21 year old). another participant described losing his job, "i have been laid off from work till further notice, so i have not been working. so it is affecting me that way." (p10, white, 28 years old) participants felt the nancial impact of job losses on other social determinants, such as housing stability. a participant shared, "ya empiezo a tener di cultad; no sé cómo voy a hacer este mes para pagar mi renta." ["i am already having di culty; i don't know what i am going to do this month to pay my rent."] (p5, latinx, 25 years old) participants who had jobs and were able to continue working during the stay-at-home order felt fortunate to be able to maintain an income. however, they also worried about exposure to covid-19 when ful lling roles as essential workers. a participant noted, "i think what makes it challenging is that i work in the public and interact with people every day, and i am not sure where they have been and if they have covid-19 or not. i just think that interacting with people who might have it on a daily basis makes it hard." (p14, black/african american, 27 years old) participants reported a reduction in in-person social support. a participant noted, "it is affecting my interactions with other people; i do not see my family and friends anymore." (p9, white, 23 years old). another remarked on his loneliness saying, "there are times when i think, if i had a boyfriend or a roommate, someone that at least can stay in quarantine with me, that will be better. i mean, i have a cat, but it is just hard sometimes." (p10, white, 28 years old) the economy and its impact on self, families, and friends are concerns participants also reported worrying about the long-term implications of the pandemic for local, regional, and global economies. as a participant shared, my biggest concern is [that] the way that it is happening here will have a devastating impact on the economy, just because it's been so bad. i have such a big fear that this will reach areas of underdeveloped counties where the health system is even weaker than ours, and they will not be able to handle that. in addition, i think that when the economy is not doing well in america, the whole world economy falls after that. (p7, black/african american, 23 years old) participants also worried that states may be re-opening businesses and institutions before the covid-19 pandemic was under control, which could lead to more transmission. as a participant noted, "they are leaving it to the states to reopen or not, so i am worried about its [covid-19] being spread." (p9, white, 23 years old) discussion plwh may be at increased risk for severe covid-19-related illness. in this qualitative study of a sample of racially/ethnically diverse gbmsm living with hiv, we identi ed 17 themes that we grouped into six domains. several ndings deserve further attention. first, participants had high levels of knowledge about the transmission and prevention of covid-19. while participants reported some confusion about con icting and emerging information related to covid-19, they utilized multiple and credible sources to obtain information about the pandemic and risk reduction. this nding could re ect, in part, their past participation in the wecare intervention, which improves health literacy by helping participants identify, evaluate, and use online sources of health information, including cdc and hrsa websites (21, 23, 24) . thus, despite our sample knowing quite a bit about covid-19, many plwh may need support in identifying and accessing correct and updated information to manage their health in light of the dissemination of con icting information regarding covid-19. further, hiv healthcare providers were identi ed as highly trusted sources of information about covid-19. providers must make time to assess covid-19-related information needs, correct misinformation, and support risk reduction among their patients living with hiv. participants did not, however, trust information provided by u.s. president. participants distinguished between the veracity of information about covid-19 provided by the u.s. president and information about covid-19 provided by other government leaders such as dr. anthony fauci, the director of the national institute of allergy and infectious diseases (niaid) and a member of the white house coronavirus task force. it is important to note that this study was conducted early in the covid-19 pandemic, and many participants had not yet navigated medical care, such as a routine o ce visit for hiv care, since the implementation of changes in care delivery related to covid-19. however, some participants reported having non-urgent healthcare visits canceled or postponed, and those participants who had obtained care reported not being satis ed with telemedicine appointments. covid-19 has required acceleration of telemedicine, and much is being learned about how best to provide care using this distance platform (26). as telemedicine becomes more widespread, concerns about con dentiality, access to and quality of care, reliable internet access, and health disparities must be considered. in our research with gbmsm living with hiv in the u.s. south, we have found that most own or have access to smartphones; however, most do not have access to desktop computers or laptops at home. thus, they may not have the requisite technology and/or a private place to participate in telemedicine visits that utilize a video component (21, 23, 24, 27, 28) . transition to telemedicine could potentially reduce hiv care engagement and viral suppression and increase disparities among some of the most vulnerable populations living with hiv. current efforts to improve telemedicine technology and the integration of telemedicine into clinic settings should include targeted efforts to meet the needs of vulnerable populations, including plwh. moreover, while covid-19 did not seem to affect access to hiv medications in this study, the impact of the pandemic affected adherence to medical regimens. interventions may be needed to help plwh strategize how and when they can take their hiv medications given interruption to their routines due to covid-19 (e.g., changes in job and school schedules). plwh may be particularly affected by covid-19 because they may already be experiencing stigma and isolation related to living with hiv (9) . participants noted that living through the covid-19 pandemic felt like when they rst learned of their hiv status, with similar feelings of loneliness and having no one to turn to. they reported limiting their interactions with others to reduce their risk of exposure; however, they subsequently reported feeling alone, isolated, and in need of social support. these feelings can lead to hopelessness and depression and negatively affect medication adherence and health outcomes (29). to address these challenges, interventions may be needed to bolster social support among plwh while maintaining social distancing. given that participants reported using social media at increasing levels since the initiation of the pandemic, approaches that leverage these platforms, such as those used in wecare, may hold particular promise in this context. participants also noted that the covid-19 pandemic resulted in missed educational opportunities, job loss, and nancial hardship. moreover, their worries were broad; they expressed concerns about themselves as well as others who they care about and the impact of the pandemic on the global economy. interventions are needed to address the varied and pervasive harms, health-related and otherwise, caused by the covid-19 pandemic on plwh, and also the underlying social determinants of health that can make plwh more vulnerable to these harms. it is important to note that participants in this study do not re ect the entire population of plwh or plwh in the u.s. south. participants represented a unique sample and may have bene ted from their participation in wecare. further studies are needed with participants that have not participated in such an intervention. we also note the small sample size; however, we purposefully recruited a racial/ethnically diverse sample and terminated data collection when we reached saturation. we also note that we wanted to better understand the breadth of experiences of plwh; future studies should focus on quantifying the experiences identi ed and developing targeted interventions for plwh based on these ndings. this study was designed to be a rst, early step. this study tapped into a small group of racially/ethnically diverse gbmsm living with hiv. it lays the foundation for future research exploring both the immediate and long-term impacts of the covid-19 pandemic among gbmsm living with hiv. additionally, there is profound need for novel interventions to address the impact of the covid-19 pandemic on social isolation, economic stability, access to health care, and other social determinants of health for racially/ethnically diverse gbmsm living with hiv. because increased age is a risk factor for severe illness from covid-19, and nearly half the plwh in the u.s. are over 50 (30), further indicating the potential of severe covid-19-related illness among this population, there is also need for targeted research to understand the impact of the pandemic on older plwh and interventions to support older plwh's needs related to covid-19. these data were collected within the rst three months after the rst covid-19 case was reported in nc and provide important insights about the impact of this rapidly emerging public health issue. since then, new developments have occurred, including a statewide mandate requiring the use of face coverings in public places that went in to effect in nc on june 24, 2020. at the same time, while participants reported engaging in prevention behaviors initially, their adherence with social distancing, face coverings, and use of disinfectants and sanitizers may decrease over time as fatigue sets in. it will be important to build on these early ndings within the continually changing context in terms of covid-19 infection rates, economic impacts, and state and federal government responses. the authors declare that they have no con ict of interest. all procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional review board of the wake forest school of medicine and with the 1964 helsinki declaration and its later amendments or comparable ethical standards. this article does not contain any studies with animals performed by any of the authors. informed consent was obtained from all individual participants included in the study. the economy and its impact on self, families, and friends are concerns states may be "opening up" too quickly southern states are now the epicenter of hiv/aids in the us. the washington post centers for disease control and prevention. hiv in the southern united states nc: guilford county department of health & human services social support and other factors associated with hiv testing by hispanic/latino gay, bisexual, and other men who have sex with men in the north carolina hiv/std surveillance report north carolina department of health and human services pathophysiology, transmission, diagnosis, and treatment of coronavirus disease evaluation and treatment coronavirus the burden of covid-19 in people living with hiv: a syndemic perspective north carolina identi es first case of covid-19. raleigh, nc: nc department of health and human services stay-at-home order issued for north carolina. the news & observer evidence used to update the list of underlying medical conditions that increase a person's risk of severe illness from covid-19 clinical outcomes and immunologic characteristics of covid-19 in people with hiv global, regional, and national estimates of the population at increased risk of severe covid-19 due to underlying health conditions in 2020: a modelling study estimating the prevalence of hiv and sexual behaviors among the us transgender population: a systematic review and meta-analysis characterizing the impact of covid-19 on men who have sex with men across the united states in april hiv prevention interventions with adolescents: innovations and challenges in partnerships across the integrated transitions model coronavirus disease 2019 case surveillance -united states assessing differential impacts of covid-19 on black communities cbpr to prevent hiv within ethnic, sexual, and gender minority communities: successes with long-term sustainability preliminary impact of the wecare social media intervention to support health for young men who have sex with men and transgender women with hiv a randomized controlled trial of a culturally congruent intervention to increase condom use and hiv testing among heterosexually active immigrant latino men a social media-based intervention designed to increase hiv care linkage, retention, and health outcomes for racially and ethnically diverse young msm supporting health among young men who have sex with men and transgender women with hiv: lessons learned from key: cord-257464-cjdmqcck authors: lázaro-muñoz, gabriel; torgerson, laura; smith, hadley stevens; pereira, stacey title: perceptions of best practices for return of results in an international survey of psychiatric genetics researchers date: 2020-10-03 journal: eur j hum genet doi: 10.1038/s41431-020-00738-0 sha: doc_id: 257464 cord_uid: cjdmqcck many research sponsors and genetic researchers agree that some medically relevant genetic findings should be offered to participants. the scarcity of research specific to returning genetic results related to psychiatric disorders hinders the ability to develop ethically justified and empirically informed guidelines for responsible return of results for these conditions. we surveyed 407 psychiatric genetics researchers from 39 countries to examine their perceptions of challenges to returning individual results and views about best practices for the process of offering and returning results. most researchers believed that disclosure of results should be delayed if a patient-participant is experiencing significant psychiatric symptoms. respondents felt that there is little research on the impact of returning results to participants with psychiatric disorders and agreed that return of psychiatric genetics results to patient-participants may lead to discrimination by insurance companies or other third parties. almost half of researchers believed results should be returned through a participant’s treating psychiatrist, but many felt that clinicians lack knowledge about how to manage genetic research results. most researchers thought results should be disclosed by genetic counselors or medical geneticists and in person; however, almost half also supported disclosure via telemedicine. this is the first global survey to examine the perspectives of researchers with experience working with this patient population and with these conditions. their perspectives can help inform the development of much-needed guidelines to promote responsible return of results related to psychiatric conditions to patients with psychiatric disorders. guidelines for responsible return of individual genetic research results should be context dependent [1] [2] [3] [4] [5] to ensure that return maximizes net benefit and is responsive to the needs and characteristics of the participant populations. given recent advances in identifying genomic correlates of polygenic conditions, such as psychiatric disorders, and the expanded use of more comprehensive singlenucleotide polymorphism (snp) arrays and genome and exome sequencing, psychiatric genetics researchers are increasingly managing questions about whether and how to return individual results to participants [5] [6] [7] . there is an emerging consensus among genetics researchers, including psychiatric geneticists [6] [7] [8] [9] , and research sponsors that some medically relevant genetic findings should be offered to participants. in addition, most research participants expect that researchers will return medically relevant information to them [10, 11] . given the methodological approaches (e.g., genomewide association studies comparing cases and controls) in psychiatric genetics research, a substantial portion of the participant population will have a diagnosis of at least one psychiatric disorder. an important consideration is that cognitive impairments and pathological emotional responses are symptoms of some of these psychiatric disorders [12] . if present, these symptoms could increase the likelihood of participants misunderstanding the implications of results or having a negative emotional response. there is, however, a dearth of research about the impact of returning results to individuals at risk for psychiatric disorders or who have a psychiatric diagnosis [13] . one of the few relevant studies found that individuals with depressive symptoms who were told that they were at an increased genetic risk for depression were more likely to believe they were currently experiencing major depression or would experience it in the future ("prognostic pessimism") compared to people with depressive symptoms told they were not at an increased genetic risk for depression [14] . more research has been done on the psychological and psychosocial impacts of disclosing genetic information to participants from the general population or individuals with other health conditions, such as cancer or heart disease. most of these studies have measured anxiety, depression, or other symptoms of psychological distress in response to receiving predictive genetic information and have typically not found evidence of significant or sustained negative psychological effects [15] [16] [17] . however, some evidence suggests those who may be more prone to psychological distress in response to receiving genetic results may be less likely to enroll in studies that have examined psychological distress [14, 18, 19] . in addition, there has been debate about whether quantitative measure of psychological distress, on which many of these studies have relied for drawing their conclusions, is the best way to assess the emotional impact of this information [20] . further, several studies have reported other negative impacts of receiving genetic information. for example, in one study, participants from the general population who were told they were at an increased genetic risk for developing depression using a sham genetic test reported more depression symptoms over the previous two weeks than those told they did not have such genetic predisposition [21, 22] . in another study, healthy older adults who knew that they were at increased genetic risk for alzheimer's disease (i.e., carriers of the apoe4 allele) judged their memory as worse on subjective memory scales and performed worse on an objective memory test than individuals who also carry the apoe4 allele, but were unaware [23] . empirically informed and ethically justified guidelines for returning genetic research results to patient-participants in psychiatric genetics research are critically needed because this is a quickly expanding field of genetics and return of results is a growing practice in this area (gl-m, unpublished data) [6, 7] . furthermore, though there is a lack of data on how patients with psychiatric disorders actually respond to genetic research results, the symptoms that characterize many psychiatric disorders suggest these patients are more likely to experience psychosocial harms in response to receiving results compared to control or "healthy" participants. in addition, some research has found transient psychosocial impacts of returning genetic findings even in individuals with no psychiatric disorders [24] . to develop these guidelines, the psychiatric genetics researchers' perspectives about how to return results to these patients are essential; these researchers have both the relevant knowledge of what types of results may be discovered, as well as experience with this population. thus, we conducted a survey using a worldwide sampling frame to examine psychiatric genetics researchers' opinions on these and related issues. we report descriptive statistics on researchers' perceptions of best practices for return of individual results in psychiatric genetics research. members of the international society of psychiatric genetics (ispg), the largest international society of psychiatric geneticists, and attendees of ispg's 2019 world congress of psychiatric genetics were invited via email or in person to participate in a web-based survey starting july 2019 and data collection ended december 2019. the institutional review board at baylor college of medicine approved the study. for those invited via email, reminders were sent up to three times. to increase our response rate, participants were offered a chance to win one of six $200 gift cards. the survey was developed based on the extant literature and the results of a previous study in which we (gl-m, sp) interviewed 39 psychiatric genetics researchers from 17 countries about their perspectives toward returning genetic research results to individual participants [6, 7] . data were collected with five-point likert items with response options from "strongly disagree" to "strongly agree" with a neutral midpoint ("neither agree nor disagree") with the exception of two items examining respondents' preference regarding which professional should return results and how (modality) results should be returned. preferred professional and preferred modality for returning results were queried in two separate questions by asking respondents to choose their preference from a list of seven professionals and seven modalities. survey instructions stated that questions were about adult case-participants as opposed to adult control participants, unless otherwise specified, and that adult caseparticipants would be referred to as patient-participants. a social scientist (sp) conducted two cognitive interviews [25] with psychiatric genetics researchers to assess question relevance, readability, face validity, comprehension, and survey length, which led to minor changes. the survey was then tested by ten colleagues who are not in the psychiatric genetics field and piloted with five psychiatric genetics researchers. no changes were necessary based on the pilot. the survey was administered in english using qualtrics and distributed via email or in person using a personalized link. the survey took~15-20 min to complete. we report response frequencies for each item. likert item data are reported as agree, disagree, and neither agree nor disagree by combining the two responses on each end of the scale (e.g., strongly agree and agree). we also calculated median and interquartile range on full likert scale responses to each survey item. for preferred professional and modality for disclosure of results, we report the percentage of respondents that selected each option. differences in sample sizes reflect missing responses. we invited 2024 psychiatric genetics researchers to participate in the survey; 490 individuals opened the link. nine people indicated they did not want to participate. of the 481 people who agreed to participate, 74 did not provide answers to any questions, leaving 407 respondents (85%) for analysis. our final response rate was 20.1% of those invited. participant demographics are reported in table 1 . we received responses from researchers from 39 different countries. approximately half (54%) of researchers were female, 28% held mds, and 58% held a phd without an md degree. overall, 66% reported they were responsible for "overall study design" and 81% were involved in analysis of genomic samples/data. the majority (86%) reported they used array-based testing (e.g., snp arrays) in their research and many were also using genome (48%) and exome (38%) sequencing and single-gene testing (32%). respondents' roles, type of genetic testing used, disorders examined, and patient populations are shown in table 2 . respondents' perspectives toward challenges to offering to return individual genetic research results related to psychiatric disorders to patient-participants are reported in fig. 1 . additional detail on response distributions is available in supplementary materials 1 and 2. most researchers (77%) felt that a significant challenge to offering return of results is that patient-participants with psychiatric disorders could have a negative emotional reaction in response to receiving results, and that little research exists about the impact of returning results to these patientparticipants (75%). furthermore, nearly half (48%) of respondents agreed return of results should be delayed if a participant is experiencing significant psychiatric symptoms. the vast majority of researchers (89%) also agreed that patient-participants may misinterpret or misunderstand results. on the other hand, most researchers agreed that practices for returning medically relevant findings should be the same for patient-participants and controls (66%), and the same for results related to psychiatric disorders and nonpsychiatric disorders (66%). most agreed that other significant challenges to returning results are that clinicians lack knowledge and understanding about how to manage results (78%), results generally lack individual-level meaning (72%), and results often lack implications for treatment (83%). (11) other european countries 15% (51) asian countries 5% (18) other countries in the americas 4% (12) african countries 2% (7) other oceania countries 0.3% (1) academic degree (n = 351) a researchers also noted practical and societal challenges. most (59%) agreed that a challenge to returning results is that many studies do not address return of results in their consent forms. in fact, only 40% of respondents indicated that their own studies' consent forms addressed the issue of whether results would be returned to participants, with an additional 15% addressing it only in some of their studies' consent forms. most agreed that when obtaining informed consent, it is too difficult for researchers to explain to participants the range of results that could be generated in the study (63%), as well as too difficult for participants to understand that range (67%). a substantial number agreed that it is difficult for researchers to set up the infrastructure necessary to return results (69%), and that it is too expensive to offer return of results (40%). finally, 39% of researchers agreed that a significant challenge to returning results related to psychiatric disorders is that it could exacerbate mental health stigma, and that it could lead to discrimination by insurance companies and/or other third parties, such as schools and banks (71%). researchers were asked about the process of offering individual genetic research results related to psychiatric disorders to patient-participants. most (84%) agreed that patient-participants should be able to opt out of receiving all results related to psychiatric disorders, and 87% agreed that participants should be able to opt out of receiving specific types of results related to psychiatric disorders (e.g., medically actionable vs. nonmedically actionable). respondents (71%) also felt that participants should be able to choose whether research results related to psychiatric disorders are included in their medical records. finally, a third of researchers (34%) felt that when using genome/ exome sequencing, psychiatric genetics researchers have a responsibility to look for medically actionable information (e.g., acmg-59) even when it is not the focus of the study, and 32% agreed that psychiatric genetics researchers have a responsibility to reanalyze genomic data over time and recontact participants if medically relevant findings are discovered. forty percent of respondents agreed that researchers have a responsibility to offer results related to psychiatric disorders discovered incidentally, but many were ambivalent about this, with 33% selecting neither agree nor disagree. most researchers (71%) agreed that results related to psychiatric disorders should be confirmed by a clinically certified laboratory before being returned to participants. many respondents were unsure or ambivalent about to whom the results should be disclosed. when asked whether results related to psychiatric disorders should be returned directly to participants (or their legal guardian, if applicable), a third of respondents agreed, a third disagreed, and a third selected "neither agree nor disagree." on the other hand, 41% agreed that results should be returned indirectly through a participant's treating psychiatrist, and a third of respondents selected "neither agree nor disagree." participants were also asked by whom and via what modality they thought medically relevant genetic research results related to psychiatric disorders should be disclosed to participants. respondents were most supportive of results being returned by those with clinical genetics expertise, including a genetic counselor (89% agreed) and a medical geneticist (77%). they were less supportive of results being returned by the patient's treating psychiatrist (57%), a physician researcher (36%), the patient's primary physician (25%), or a nonclinician researcher (11%). when asked which type of professional would be their preferred person to return findings, the majority (53%) selected genetic counselor and 20% selected medical geneticist (fig. 2) . when asked via which modality they thought medically relevant genetic research results related to psychiatric disorders should be returned, the vast majority of respondents (92%) agreed that such results should be returned in person, while 45% agreed they should be returned via telemedicine (secure video call). researchers were less supportive of other options: 21% agreed that results should be returned online via a secure website, 17% via telephone, 9% via percentage of respondents who agreed/strongly agreed i think a significant challenge to offering to return individual genomic research results related to psychiatric disorders to patient-participants is that... fig. 1 psychiatric genetic researchers' perspectives on challenges to offering to return. results related to psychiatric disorders to patientparticipants. mail, and 7% via email. when asked to choose which modality would be their preferred method for returning results, 85% selected in person and far fewer respondents selected each of the remaining options (fig. 2 ). respondents agreed throughout the survey that there is potential for patient-participants to experience negative psychosocial impacts in response to receiving genetic research results related to psychiatric disorders. most researchers believed patient-participants could have negative emotional reactions to results, may misinterpret results, and that there is little research on the impact of returning findings to these participants. though we are unable to determine whether the researchers' concerns were specific to patient-participants with psychiatric disorders, we found previously that psychiatric genetics researchers expressed related concerns and highlighted that they can be especially problematic when working with patient-participants with psychiatric disorders. for example, researchers expressed that in some cases these patient-participants' "cognitive function may not be as good as other people's, so it [could] be very easy to misread the information […]" and that in psychiatric genetics research "we have highly anxious people, we have depressive people. they consistently take information more negatively that they should [6] ." consistent with these findings, researchers believed that return of results should be delayed if a participant is experiencing significant psychiatric symptoms. importantly, when asked whether return of results practices should be different for patient-participants and control participants, however, researchers disagreed. this suggests that though researchers have concerns about potential negative psychosocial impacts of returning results to patient-participants, either these concerns are not significant enough to merit managing the return of results differently with patients, or they have similar concerns about negative psychosocial impacts to control participants and thus the same level of care should be taken. another potential explanation for why most researchers do not believe patient-participants should be treated differently is that psychiatric genetics researchers are concerned that treating patient-participants differently may perpetuate stigma and undue discrimination that patients with psychiatric disorders often experience [6, 26] . most researchers agreed that returning results could lead to discrimination by insurance providers, schools, banks, and other third parties. this could be a reason why most researchers also thought participants should be able to choose whether medically relevant findings should be included in their medical records. once in the medical record, it becomes easier for insurance providers (e.g., life insurance providers) and other third parties to gain access to this information [27] [28] [29] . thus, there is tension between wanting to return results that are medically relevant, but also wanting to protect these patients and possibly control participants from psychosocial harms and potential discrimination. respondents agreed there are a number of practical and structural challenges to responsibly returning psychiatric genetic research results to patient-participants. first, most agreed that one such challenge is that many studies do not address return of results in their consent forms. indeed, many of our respondents reported that their own consent forms did not address return of results, or they were unaware of whether the issue was addressed. this is consistent with other studies that have found that the majority of genetic research consent forms either stated explicitly that genetic results would not be returned or did not address the issue at all [30, 31] . current guidelines and best practice standards recommend that the issue of return of results be addressed in genetic research consent forms, and many recommend that research participants be given the option whether they want to receive individual research results at the time of enrollment before such results are discovered [3, 8, [32] [33] [34] [35] . in fact, some recommend that results not be returned if the participant has not previously consented to receiving this information. this presents a challenge for studies using biospecimens and data collected without such consent if they identify results they would like to offer to individual participants. in cases where the consent form allows for recontact of participants, researchers may be justified in reaching out to assess interest in receiving results. in other cases, researchers should work with their research ethics committees to assess whether offering results without consent would be justified. ideally, moving forward, researchers should address return of results in their consent forms. respondents also felt that a significant challenge to offering return of results to participants was the difficulty for researchers to explain and for participants to understand the range of results that could be generated. as noted above, guidelines recommend that genetic research participants consent to whether to receive genetic research results at the time of enrollment into these studies. these difficulties in communication and understanding may be barriers to truly informed consent regarding return of results. other research has shown that even when given options for which types of results to receive, research participants may not understand these types of results (e.g., preventable, treatable) in the same way the researchers do and that there is great variability among participants in their conceptualization of these terms [36] . this highlights the need for more research regarding how potential individual genetic research results could be best communicated to participants. a second practical challenge to returning results that our respondents confirmed was the lack of infrastructure and resources necessary to do so responsibly. these challenges have been a common refrain among researchers and other stakeholders in genetics research alongside the growing consensus to return some medically relevant results to participants. most laboratories may not have the resources or experience contacting participants to return results in a way that minimizes potential emotional harm and ensures participants understand the implications of the findings, a concern our respondents noted [6, 9] . accurate interpretation and communication of the results may be particularly important given that most researchers thought a significant challenge when returning results to patient-participants in psychiatric research is that results lack implications for treatment and individual-level meaning. in fact, most laboratories likely do not have clinicians qualified to disclose this information. furthermore, previous research suggests that many psychiatric genetics researchers believe it is important to help ensure that patient-participants whose results reveal or confirm increased risk for a psychiatric disorder have access to care [7] . the lack of clinicians that could communicate the implications of findings on many projects and concern about follow-up care may explain why an unexpectedly high number of respondents agreed that patient-participant results should be returned through the participant's treating psychiatrist. interestingly, even if the results were returned directly to the treating psychiatrists, most researchers believed that a significant challenge is that clinicians lack knowledge and understanding of how to manage results. finally, most respondents agreed that research results should be confirmed by a clinically certified laboratory before returning them to participants, which represents additional logistical and financial burdens. establishing an infrastructure for returning results to participants that meets researchers' ideal for how this should be done would require significant investments from research sponsors. some have expressed concern that this could divert funds away from research [37] . however, if research sponsors provide the resources necessary to develop this infrastructure, returning medically relevant psychiatric and nonpsychiatric genomic results would be a way to demonstrate reciprocity for patients' participation by offering information many participants want, as shown in several studies [11, [38] [39] [40] . furthermore, it could increase the societal benefit of investing in psychiatric genetics research and may incentivize participation as many researchers in this field believe (gl-m, unpublished data) [6] and research has shown [11, [39] [40] [41] . thus, as psychiatric genetics knowledge grows, some patient-participants could benefit directly from these research efforts [38, 42, 43] . the american college of medical genetics and genomics (acmg) recommendation that laboratories should analyze and report "incidental" or secondary findings when conducting genome or exome sequencing in clinical settings generated considerable debate about whether researchers should follow similar practices [8, 44, 45 ]. an influential article by jarvik et al. argued that researchers have a responsibility to offer to return medically actionable findings and may be ethically and scientifically justified in offering some nonmedically actionable findings, but that participants should be able to opt out of receiving any findings [8] . psychiatric genetics researchers seem to support this notion. in previous publications, we have reported that the vast majority of psychiatric genetics researchers agree medically actionable findings should be offered to participants, and here we found that most researchers agree participants should have the opportunity to opt out of the return of results and even opt out of the return of specific categories of results (e.g., medically actionable vs. nonmedically actionable) (gl-m, unpublished data) [6, 7] . jarvik et al. article, however, maintained that researchers do not have a duty to analyze and offer findings that are not within the scope of the research ("duty to hunt") [4, 8] . interestingly, a third of researchers in our sample agreed that they do have a responsibility to look for medically actionable information (e.g., acmg-59) even when it is not the focus of the study. a substantial number of researchers also agreed that they should offer to return results discovered incidentally. furthermore, there has been significant debate about whether researchers and clinicians have a responsibility to reanalyze genomic data and recontact patients or participants if the interpretation of a genomic finding changes in a way that could have medical implications [3, 46, 47] . the general consensus has been that researchers do not have a duty to reanalyze in part due to feasibility constraints once a study's funding has ended [3] ; however, the american society of human genetics and others have recently expressed support for a limited duty to recontact in the research context [48] . about a third of researchers in our sample agreed that researchers should reanalyze genomic data over time and recontact participants if medically relevant findings are discovered. respondents felt that if medically relevant genetic research results were to be returned to participants, they should be disclosed by a clinical genetics professional, with most supporting disclosure by genetic counselors. this is consistent with recommendations and research that urges disclosure of genetic research results by a professional who has expertise in both genetics and communication of such information [29, 49, 50] . though this may be the ideal, high costs and shortages of genetic counselors, particularly in some areas of the world, may make this a nonscalable solution for now. further, our respondents were most supportive of returning results in person, which is often noted as ideal yet unrealistic due to issues of limited workforce, efficiency, and cost [51] . this is also impracticable for those living outside urban settings, where most genetic services are offered [52] , or in other areas of the world where genetics specialists are in short supply. while studies have found telephone delivery of genetic results to be a tenable alternative to in-person disclosure [3, 53] , our respondents were not very supportive of this mode of delivery. in order to meet demand as returning individual results to participants becomes increasingly common, however, other, more scalable options will be necessary. our respondents were more supportive of the use of telemedicine over telephone for returning results, which may reduce burden on both the research and participant side, and therefore maximize the capacity of relevant genetic specialists to return results. it is also important to note that these data were collected before the covid-19 pandemic, during which many integrated teleconferencing into medical and research practices. this may lead to more acceptance of telemedicine. some challenges will remain, though, including issues around access, privacy, and providing services across jurisdictions. we sampled a diverse group of psychiatric researchers across 39 countries, but results may not be representative of the larger population of psychiatric genetics researchers. because respondents self-selected for participation, it is possible that those with stronger opinions or those who were more familiar with the issue of return of research results may have been more likely to respond. there is also potential for social desirability bias with some survey questions due to the aforementioned emerging consensus in the field that some medically relevant research results should be offered to participants. notwithstanding, this is the first study to assess the perspectives of an international sample of psychiatric genetics researchers on the challenges of and ideal practices for returning results to their participant populations. guidelines for safe and responsible return of genetic research results to participants should be context specific. our findings indicate that many researchers feel that the potential for patient-participants in psychiatric genetics studies to have a negative emotional response or misunderstand results are significant challenges to returning results in this field and that return of results should be delayed if a participant is experiencing significant psychiatric symptoms. respondents also agreed that there are a number of practical and societal challenges. though respondents felt that genetic results should ideally be disclosed by a genetic counselor and in person, they were moderately supportive of other options that may be more scalable, such as telemedicine. given recent advances in psychiatric genetics research alongside an emerging international consensus that some medically relevant genetic research findings should be offered to participants, guidance on 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from sequencing research public expectations for return of results from large-cohort genetic research disclosing individual cdkn2a research results to melanoma survivors: interest, impact, and demands on researchers a survey of u.s adults' opinions about conduct of a nationwide precision medicine initiative® cohort study of genes and environment do participants in genome sequencing studies of psychiatric disorders wish to be informed of their results? a survey study stakeholders in psychiatry and their attitudes toward receiving pertinent and incident findings in genomic research acmg recommendations for reporting of incidental findings in clinical exome and genome sequencing point-counterpoint. ethics and genomic incidental findings is there a duty to reinterpret genetic data? the ethical dimensions communicating new knowledge on previously reported genetic variants the responsibility to recontact research participants after reinterpretation of genetic and genomic research results disclosure of individual research results in clinico-genomic trials: challenges, classification and criteria for decision-making clinically significant germline mutations in cancer-causing genes identified through research studies should be offered to research participants by genetic counselors my46: a web-based tool for self-guided management of genomic test results in research and clinical settings analysis of advantages, limitations, and barriers of genetic counseling service delivery models randomized noninferiority trial of telephone versus in-person genetic counseling for hereditary breast and ovarian cancer 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. key: cord-307187-5blsjicu authors: missel, malene; bernild, camilla; dagyaran, ilkay; christensen, signe westh; berg, selina kikkenborg title: a stoic and altruistic orientation towards their work: a qualitative study of healthcare professionals’ experiences of awaiting a covid-19 test result date: 2020-11-11 journal: bmc health serv res doi: 10.1186/s12913-020-05904-0 sha: doc_id: 307187 cord_uid: 5blsjicu background: extensive measures to reduce person-to-person transmission of covid-19 are required to control the current outbreak. special attention is directed at healthcare professionals as reducing the risk of infection in healthcare is essential. the purpose of this study was to explore healthcare professionals’ experiences of awaiting a test result for a potential covid-19 infection. methods: qualitative interviews with 15 healthcare professionals were performed, underpinned by a phenomenological hermeneutical analytical framework. results: the participating healthcare professionals’ experiences of awaiting a covid-19 test result were found to be associated with a stoic and altruistic orientation towards their work. these healthcare professionals presented a strong professional identity overriding most concerns about their own health. the result of the coronavirus test was a decisive parameter for whether healthcare professionals could return to work. the healthcare professionals were aware that their family and friends were having a hard time knowing that the covid-19 infection risk was part of their jobs. this concern did not, however, cause the healthcare professionals to falter in their belief that they were doing the right thing by focusing on their core area. the threat to own health ran through the minds of the healthcare professionals occasionally, which makes access to testing particularly important. conclusion: the participating healthcare professionals had a strong professional identity. however, a discrepancy between an altruistic role as a healthcare professional and the expectations that come from the community was illuminated. a mental health coronavirus hotline for healthcare professionals is suggested. the covid-19 pandemic puts healthcare professionals (hcp) under pressure both physical and psychological [1] . the challenges include increased workload created by the outbreak but also fears of contagion for themselves, their families and patients. particularly psychological health outcomes and distress are highlighted in current research regarding the initial stage of the covid-19 outbreak in terms of anxiety, depression and post-traumatic symptoms [1] [2] [3] [4] [5] . across these studies hcps working during the epidemic report frequent concerns regarding their own health. based on our knowledge, little information is however available regarding the impact on hcps awaiting a test result for potential covid-19 infection or interventions for supporting them during this waiting time. therefore, this study aim to shed light on hcps' experiences of awaiting a test result for a potential covid-19 infection through individual interviews. this qualitative investigation will thus highlight what is at stake for hcps while in quarantine and awaiting a response as to whether they are infected with the coronavirus. the study offers an in-depth understanding of the meaning of the waiting for the test result for covid-19 infection from the hcps' perspective and should be of interest to a broad readership and add knowledge to the growing covid-19 evidence base and in developing supportive inetrventions targeted hcps in such a pandemic. while hcps, e.g. nurses, physisians, porters and healthcare workers, are caring for some of the most vulnerable groups of people both in hospital but also in primary care, they are currently also facing an unprecedented disease caused by the outbreak of a previously unknown virus [6] . this new coronavirus that can cause covid-19 disease [7] puts hcps in a position where they must avoid exposing themselves to infection but also avoid transmitting the infection to the vulnerable patients and citizens to whom they have a caring responsibility. because an infected hcp is a potential vehicle for virus dissemination, research suggests that reducing the risk of infection amongst hcps is essential [8] . spread of virus has been reported during the ebola outbreak resulting in a compromised healthcare system [9] as well as during the severe acute respiratory syndrome (sars) [10] and the middle east respiratory syndrome (mers) epidemics [11] . experiences from these previous outbreaks highlight fear among hcps in transmitting the disease and the importance of screening for the virus. on 30th january 2020, the world health organization declared the chinese outbreak of covid-19 to be a public health emergency of international concern. the emergency committee stated that the spread of covid-19 may, among other preventive efforts, be interrupted by early detection and isolation [7, 12] . general hygiene precautions are crucial in order to minimize the risk of contamination [8] . hcps have always played an important role in infection prevention, infection control, isolation, containment and public health, which for nurses initially was advocated for by florence nightingale [13] . there are studies that define the pathophysiological characteristics of covid-19 however, the mechanism of spread is uncertain. current knowledge is derived from similar coronaviruses, which are transmitted from human-to-human through respiratory infection [7] . typically, respiratory viruses are most contagious when a patient is symptomatic. however, increasing evidence suggests that human-to-human transmission may be occurring during the asymptomatic incubation period of covid-19 [14, 15] . the disease is reported to be very contagious, and measures to reduce person-to-person transmission of covid-19 are therefore required to control the outbreak [14] [15] [16] . special attention and efforts to prevent or reduce transmission is applied in susceptible populations including hcps in order to reduce transmission to patients or other vulnerable groups of people in the community [17] [18] [19] . hcps are thus among those groups of people who are being rapidly tested for coronavirus in denmark. considering the severity of infection and illness [20] , the test result might be of great importance for the healthcare system but also for the individual hcp. a sudden decrease in the number of hcps because of quarantining or isolation due to covid-19 infection would potentially overload the healthcare system and the capacity to treat either patients with coronavirus or patients with other serious conditions would be challenged [8] . for the individual hcp, it might furthermore be a threat to their own health. as far as we are aware, no research has so far focused on how hcps might perceive this test situation. therefore, the purpose of this study is to explore hcps' experiences of awaiting a test result for a potential covid-19 infection. such knowledge from the hcps' perspective are expected to increase the awareness of potential needed support while awaiting a crucial test result from a contagious and rare virus. furthermore, the study will help hospital managers to establish strategies to ensure the best possible working conditions for hcps during the pandemic. this study used a phenomenological hermeneutical methodology inspired by ricoeur's narrative philosophy [21] . in this study phenomenology was apllied as an epistemological stance for exploring first-person accounts of what it is like to wait for a test result for potential covid-19 infection. pre-reflexive experiences from the participant's lifeworld is the starting point, while hermeneutics was focused on interpreting the surplus meaning contained in this lifeworld. as human beings we leave traces when we express ourselves, and these traces are formed by the meanings and traditions to which we belong. often, it is impossible to directly understand individual's experiences because the sense in the traces is hidden. therefore, reflection on an individual's lived experiences takes place via the narratives expressed by the individuals [21, 22] . the threefold mimesis is central in ricoeur's narrative philosophy and can be seen as an epistemological approach for understanding the participants' lived experiences [23] , which, in this study, has inspired the research process as a three-fold process [22] : mimesis i (prefiguration): the life lived before it is formulated as spoken or written narrative (data collection); mimesis ii (configuration): the language stage, formulating a narrative (from speech to text); and mimesis iii (refiguration): the comprehension stage, when the text is interpreted (analysis and interpretation) [21] [22] [23] . participants in this study were recruited from a population of hcps who had been tested for coronavirus but who did not necessarily care for covid-19 patients. if they had symptoms of covid-19 infection, hcps in denmark were offered testing for the virus. we used a convenience sampling strategy [24] by encouraging tested hcps to approach the research team by e-mail if they were willing to attend an interview. the interviews were conducted by telephone based on ethical accountability for not contributing to the spread of the virus and they were scheduled in the gap between test and its result. the result of the test was during the study period given to a tested person within 24 h. the society of denmark was on lockdown due to the threat of coronavirus on march 11th 2020. coronavirus was in this period still relatively new in denmark, and 300-500 patients were hospitalized and 77 patients died due to covid-19 during week three of the epidemic. fifteen hcps agreed to participate in the study and were interviewed in march and april 2020. thereafter data saturation was achieved, making further interviewing unnecessary [24] . we included hcps with different professional backgrounds and different responsibilities from both primary care and hospitals. the characteristics of the participants are shown in table 1 . data were collected through individual interviews. human events are characterized by unreflecting preunderstanding, which ricoeur calls prefiguration (mimesis 1) [21, 22] . with the aim of gathering the participants' indepth narrative accounts of their experiences of awaiting a covid-19 test results, open questions were used. each interview began with a broad opening question, such as; "could you please tell me what led you to being tested for a potential covid-19 infection and your experiences while awaiting the test result?" table 2 lists the interview questions. the interviews lastet on average 30 min (range 9-55 min). the interviews were separately conducted by three experienced qualitative researchers who all had a professional background as registret nurses, and interviews were audio-recorded and transcribed into 217 pages. the participants' stories were thus transcribed into a textual configuration of their unarticulated experiences (from prefiguration to configuration) [21, 22] . according to ricoeur, people's narratives contain surplus meaning and hermeneutics is concerned with interpreting this surplus meaning (from configuration to refiguration). the study was undertaken in accordance with the guidelines of the danish ethical research committee and was approved by the danish data protection agency (p-2020-276). the investigation conforms with the principles outlined in the declaration of helsinki [25] . the participants received written information about the purpose of the study and their right to withdraw at any time. written informed consent was obtained from each of the participants before the interview. data were anonymized by means of identification codes. the participants were informed that interview data would be treated confidentially. according to ricoeur, interpretation is the central methodology in phenomenological research. interpretation involves a process consisting of naive interpretation, structural analysis, and comprehensive understanding [26] . naive interpretation is superficial interpretation, whereby the narratives are read and re-read to see what the texts mean to the researchers, giving an overall view of the narratives. structural analysis deals with patterns in the text that can explain what it is saying. explaining what the text expresses means moving from what the text says to what it is talking about. during the structural process, we analyzed and structured the narratives based on units of meaning, extracting meaning or themes that recurred in the narratives. the units of meaning were condensed such that the essential meaning was expressed. these units of meaning were then further condensed and gathered into themes [22, 26] . the comprehensive understanding continues with a discussion of the themes that were identified in the structural analysis, the purpose being to reach a new understanding of the possible dimensions of the participants' experiences while awaiting a covid-19 test result. the deeper interpretation of the narratives is a process of understanding in which theoretical perspectives are drawn on to help clarify and comprehend phenomena in the participants' experiences [22, 26] . see fig. 1 . throughout the study methodological rigor was attained by using the qualitative concepts of relevance, validity, and reflexivity, as described by malterud [27] . this study is one of only a few qualitative studies exploring the lived experiences of hcps during the covid-19 pandemic and to our knowledge this is the first qualitative study exploring hcps' experiences of awaiting a test result for a potential covid-19 infection. the qualitative interview method was selected in order to gain insight into these individuals' perspectives in order to understand the meaning of the investigated phenomena, i.e. the transition from experience to meaning [26] . the relevance of the study and the chosen methodology thus seems appropriate. several strategies were employed to demonstrate internal validity, including collecting indepth data, prolonged involvement with the data and use of the participants' own words to formulate and illustrate themes. the participants are quoted in order to ensure transparency and substantiate the findings of the study. ricoeur's steps in the analytical process are clearly set out and have been stringently followed. the process from prefiguration through configuration to refiguration reflects the shift from lived life to narrative accounts of lived life to the final interpretation, which provides an insight into the individual hcps' concrete experiences and into universal phenomena of life for hcps awaiting a test result. thus other researchers are able to judge and validate the extracted themes. reflexivity was ensured by discussions between the authors, both during the data collection phase and in the analysis. the fact that all interviewers were registered nurses meant that a certain agreement but also equality between participant and interviewer was present. this meant that the conversation was relatively easy and straightforward. in order, however, to prevent blind spots in relation to the research purpose, the interviewers were particularly aware of their role as researchers and qualitative interviewers and tried to bridle preunderstandings from their background as hcps and adapting a curious stance. the comprehensive understanding illuminated the meaning of the participants' experiences of awaiting a covid-19 test result as a stoic and altruistic orientation towards their work. these hcps presented a strong professional identity overriding most concerns about their own health. the result of the coronavirus test was a decisive parameter for whether healthcare professionals could return to work. experiences related to the test situation as well as the strong sense of professional identity will be described in more detail in the following. what led the participants to the test for coronavirus were their experiences of mild to moderate symptoms, which aroused suspicion of possible infection. they described the importance of protecting patients, vulnerable citizens and colleagues from the risk of infection and therefore stayed away from work until they were certain that they were not contributing to the spread of the virus. this distance from work, however, had an impact on participants who described a dilemma in terms of both feeling responsible and hypochondriac at the same time. as hcps they already knew the usual workload and therefore described feelings of failing colleagues by not taking part in the work, "we are busy in healthcare, so if there is one who is sick, then the others just have to run faster" (participant k). thus, the test result was extremely important in terms of whether one could return to work and help one's colleagues. the participants, furthermore, talked of particular responsibilities in being prepared to care for and treat patients with covid-19. they watched what is going on in the rest of the world in other healthcare settings where the epidemic of covid-19 exceeded the healthcare systems' resources. they were very concerned about their colleagues in other countries but at the same time had an altruistic view that they themselves must also be prepared. in this context, coronavirus tests are also particularly important for the participating hcps. they did, however, describe an ambivalence around the test response; if you are tested positive, then hopefully you will form some kind of immunity and thus be able to go to work after a period of quarantine without being infected again. if, on the other hand, you are tested negative, you can return to your job immediately, "i hope i don't have corona, but on the other hand, then you have had it …" (participant c). participants describe concerns and fears that many hcps will be infected at the same time, and that there will be no one to take care of the ill patients or vulnerable citizens. therefore, it was necessary to have the hcps tested so that an overview of the workforce can be maintained as hcps cannot easily be replaced. the way to being tested could, however, be quite obscure for some of the participants. for participating hcps working in the hospital, access to testing is easy and straightforward. they noticed symptoms, they discussed it with their boss, and they got tested. however, working in primary care posed major problems in figuring out access to being tested. those hcps narrated experiences of not being taken seriously, which produced a kind of powerlessness, "all of us who work in healthcare, we are there to make a difference, but you just feel that we sometimes are banging our head against the wall [experiencing lack of understanding] … it gives a sense of powerlessness" (participant e). they furthermore described frustrations of wasting precious time waiting to get to the test; time that could have been spent usefully in continuing their work. the particular commitment to caring for vulnerable and ill people was evident when participating hcps were just waiting to be tested. even though being tested for coronavirus when experiencing symptoms was strongly preferred by the participants in this study, the test situation, however, reminded and confronted them with the seriousness of the pandemic. they described their experiences of coming into the interimistic tents outside the hospital and meeting with test staff in protective equipment. the participants, being hcps, were prepared for this scenario but are anyway confronted with feelings of being part of a surreal experience or a science fiction movie but also that this new virus was real, "it is a peculiar experience to meet another person who is covered from head to toe. you suddenly feel very dangerous" (participant f). they also, however, told of a professional set-up and that being tested provided certainty, tranquility and direction. the participating hcps in this study presented a strong sense of professional identity and were highly oriented towards their work. they talked about how they were preparing for battle against the coronavirus despite the risk of being infected themselves. the frontline hcps with the critical task of caring for covid-19 patients told how for a long time and with no evidence of even having the disease, they had isolated themselves at home, "i already decided 14 days ago that we should stop sleeping in the same room and avoid physical contact completely. i have also written on my wife's and my behalf to family and friends that we will not be able to see anybody for a while" (participant b). they were tremendously aware of their specific role and duty and that nobody could stand-in for them and explained it as just being a part of their job and with a fatalistic attitude. these participants expressed a paramount need to know if they were contagious. common to the participants was that, by virtue of their profession, they had important professional knowledge about drop infections, hygiene, symptoms and pathways of infection, all of which gave them a readiness to act. they narrated how they were extremely aware of not transmitting the infection to others, as well as how to take distance and hygiene measures when they noticed symptoms of potential covid-19. these measures seemed to be integrated as an almost natural act in the participants' lives with them not questioning the necessity of doing so, "i've locked myself inside a room now and told the others in the family to stay away. and if i'm going to the toilet ..., our apartment is quite small ... but then i just shout that now i go to the toilet. and then i have hand sanitizer and cleansers and wipe it all off afterwards" (participant c). the situation thus appears to have been tackled with stoic calm by the participants as they awaited answers as to whether their possible symptoms are related to covid-19. despite their professional knowledge, participants also told of chaotic and conflicting information from the healthcare system expressed as an information flow that had become incomprehensible and overwhelming. this resulted in uncertainty and difficulty in keeping up with guidelines. the participants' social network was marked by the possible threat of covid-19 from the hcps who were just doing their job in healthcare. the participating hcps were highly aware that their family and friends were having a hard time knowing that the covid-19 infection risk was a necessary condition of their job, while they at the same time are forced to keep a distance. this concern did not, however, cause participants to falter in their belief that they were doing the right thing by focusing on their core area, which was caring for ill and vulnerable people. the threat to their own health ran though the minds of the participants once in a while, "that people who take care of their work and do what they can to make others survive can end up getting infected with covid-19 themselves, i think that's a little hard, but that's just how it is" (participant g). the participating hcps express a need to share such thoughts with somebody and ask for some kind of follow-up or a hcp corona hotline, e.g. after being tested for the virus, "when you are nervous and scared, it would be helpful if you could go to one specific place where knowledge and expertise about corona was gathered -a mental health corona hotline" (participant d). being oriented towards their job was described as a natural part of the participating hcps approach to life. they had a strong passion for and pride in their work and in this epidemic context showed solidarity across professional boundaries. they did question if they may be too uncritical but explained it with the fact that they are in a time when it is necessary to do as one is told. the participants, however, described how they have experienced the community tribute e.g. public applause for them as on the edge of hypocrisy. they rejected more applause from society and express how genuine societal recognition would be more resources in hospitals to solve problems and to give the hcps a tolerable everyday life and a decent salary. awaiting a covid-19 test result for the participating hcps was associated with a stoic and altruistic orientation towards their work in which the result of the test was crucial. this study illuminated how hcp prepare and get ready for battle against covid-19 in a devoted and solidarity-based way. this war metaphor as a response to the pandemic might illuminate the hcps' stoic and altruistic work identity. seeing the coronavirus as an enemy that should be defeated and as a part of one's job require hcps who approach their work with a stoic calm and an altruistic attitude. a similar commitment to supporting their health system and communities has been reported during the ebola epidemic [28] . the participants in our study presented a strong professional identity and their attention was directed to caring and protecting patients and vulnerable citizens while also preventing the spread of infection among colleagues. being stoic in their approach to work does not mean that hcp are cold and distant, it is rather an attitude of remaining calm and carrying on and may also involve having a certain degree of self-control and maintaining a sense of conscious self-awareness [29] . the altruistic attitude or behavior of the participants was characterized by the fact that the individual sought to promote the well-being of others without thought for their own interests and needs. according to hume, altruism is a character trait of humans that normally extends to strangers only in a weakened form and it is rare to meet with one in whom the affections of altruism do not over-balance the selfish [30] . altruism was, however, a strong moral part of the participants' professional identity which seems to be based on the inner logic of the hcp discipline. understanding of the roles altruism might play in the social and medical response to an epidemic and the stories about the nature of hcps' moral obligations has been discussed and implies the willingness to take personal risks in the line of duty [31] . a professional identity can be defined as a social identity that relates to people's understanding and presentation of themselves as professionals [32] . it is seen as the identity a person has developed through learning and practicing a given profession and thus can fulfill a particular employment function designed and integrated into a given work and professional culture. according to goffman, identities are not created individually, but rather the individual gains his or her professional identity through the attribution of certain characteristics that have the character of normative expectations [33] . in addition to performing the expected functions associated with a specific field, the individual thus supports and supplements his or her position by simultaneously playing the normatively expected role associated with that group [33] . to follow goffman [33] , the stoic and altruistic orientation towards their work presented by hcp in the present study might also point to these hcp acting in accordance with a specific role within a given social context, such as healthcare. society's normative expectations of hcp may influence their perception of their own professional identity. our study, however, illuminates a discrepancy between an altruistic role as hcps and the normative expectations that come from the community that pays tribute to them, and then an experience of working conditions and salaries that do not indicate recognition. altruism has been reported to be declining in the face of economic and pragmatic motivation [34] which might threaten healthcare practice during an epidemic such as covid-19. another threat to our study participants' stoic and altruistic orientation towards their work was also experiences of receiving chaotic, conflicting and an overwhelming information flow resulting in difficulties in keeping up with best practice guidelines. research from the a/h1n1 influenza pandemic have demonstrated how perceived sufficiency of information was associated with reduced degree of worry and how hcps less frequently felt unprotected [35, 36] . these points highlight that hospital managers should try to provide and direct information for hcps according to what is needed during the different and specific phases of a pandemic based on the affected hcps' perspectives in order to offer favourable working conditions in times of extreme distress. being tested for coronavirus for the hcps in our study was significant in order to maintain their professional identity and continue working. they did, however, also describe experiences of uncertainty and fear for own health and expressed a need to share such thoughts with somebody. a threat to the mental health of hcps during epidemics has been reported [4, 5, 37] , and interventions to promote mental well-being in hcps exposed to covid-19 are suggested to be immediately implemented [37] . a hotline for patients during the current covid-19 outbreak has been established in some places, e.g. in new york where citizens are guided to assess their own symptoms at home and can discuss any psychological impact from the disease [38] . similar initiatives directed at hcps are needed. recomandations from a recent systematic review also suggest to establish a forum for medical personnel to voice their concerns as well as a psychological assistance hotline comprised of volunteers who have received relevant psychological training to be able to provide telephonic guidance to personnel to help effectively tackle mental health problems [39] . telephone interviews in this study were unavoidable due to the risk of virus transmission between participants and interviewers. such interviews do, however, have some disadvantages. they are more impersonal in that it is not possible to have eye contact, and as an interviewer, it is difficult to show that you are interested and included in what is being said. in addition, breaks are generally less acceptable [24] . despite this, we found that participants were willing to participate in the study and appreciated talking about their experiences. the sample included in this study consisted of more female hcps (n = 11) and most were nurses (n = 8) which might be an uneven distribution of participants. women, however dominate the nursing profession, and nurses are the largest professional group in healthcare [40, 41] and the sample thus represents the general healthcare workforce. what is worth noting is that this study was conducted during the first phase of the pandemic. this means that the stoic and altruistic orientation as well as the war metaphor that we have found and described may change over time as the pandemic progresses and hpcs may experience burnout. the perspectives of hcps awaiting a test result for coronavirus provide an important contribution to the growing body of literature about covid-19. these hcps had a strong professional identity with their attention directed towards caring and protecting patients and vulnerable citizens while also preventing the spread of infection among colleagues. a discrepancy between an altruistic role as a hcp and the normative expectations that come from the community was also illuminated. the clinical implications of this study is thus, that as a stoic and altruistic attitude dominated hcps' identity, access to testing for covid-19 for these professionals is crucial. furthermore, a mental health corona hotline for hcps should be established. abbreviations hcp: healthcare professionals mental health care for medical staff and affiliated healthcare workers during the covid-19 pandemic timely mental health care for the 2019 novel coronavirus outbreak is urgently needed prevalence 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covid-19 pandemic factors affecting the psychological well-being of health care workers during an epidemic: a thematic review sundhedsvaesen og sundhedspolitik (healthcare and healthcare politics) closing the gap in indigenous health inequity -is it making a difference? publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations the research team wishes to thank all those people who collaborated and participated in this study by sharing their experiences. without them, this study would not have been possible. we also thank anne alexandrine øhlers, camilla rotvig jensen, christina jensen, mette skriver and miriam bianca besser biyai for their help in relation with the transcription of the interviews. all authors conceived and contributed to the design and conduct of the study. skb, cb and mm conducted the collection of data material and led the analysis together with swc and id. all authors were involved in the analysis and the writing of the manuscript. all authors contributed to the preparation of this manuscript and read and approved the manuscript. this work was supported by the novo nordisk foundation (grant number nnf20sa0062831), and centre for cardiac, vascular, pulmonary and infectious diseases, rigshospitalet, copenhagen university hospital, denmark.availability of data and materials all authors have full control of all primary raw data (interview transcripts) and allow the journal to review our data if requested. all raw data are written in danish. data are stored in a locked file cabinet in a locked room at the copenhagen university hospital as requested by the danish data protection agency. the data material used in this study are available from the corresponding author on reasonale request which will not conflict with the anonymity and confidentiality of the data.ethics approval and consent to participate registration and permission was received from the authorities in the danish data protection agency under the capital region of denmark: (p-2020-276) and the study were undertaken in accordance with the guidelines of the danish ethics research committee. the participants received verbal and written information about the study prior to the study. written consent was obtained from the participants. given the qualitative nature of the study, the local ethics committee in the capital region of denmark ruled that no formal ethical approval was required in this particular case. not applicable. the authors have no conflicts of competing interest to declare.author details 1 clinical nurse specialist at the department of cardiothoracic surgery, centre for cardiac, vascular, pulmonary and infectious diseases, rigshospitalet, key: cord-025556-oyfx3ij5 authors: thunström, linda; ashworth, madison; shogren, jason f.; newbold, stephen; finnoff, david title: testing for covid-19: willful ignorance or selfless behavior? date: 2020-05-08 journal: nan doi: 10.1017/bpp.2020.15 sha: doc_id: 25556 cord_uid: oyfx3ij5 widespread testing is key to controlling the spread of covid-19. but should we worry about self-selection bias in the testing? the recent literature on willful ignorance says we should – people often avoid health information. in the context of covid-19, such willful ignorance can bias testing data. furthermore, willful ignorance often arises when selfish wants conflict with social benefits, which might be particularly likely for potential ‘super-spreaders’ – people with many social interactions – given people who test positive are urged to self-isolate for two weeks. we design a survey in which participants (n = 897) choose whether to take a costless covid-19 test. we find that 70% would take a test. surprisingly, the people most likely to widely spread covid-19 – the extraverts, others who meet more people in their daily lives and younger people – are the most willing to take a test. people's ability to financially or emotionally sustain self-isolation does not matter to their decision. we conclude that people are selfless in their decision to test for covid-19. our results are encouraging – they imply that covod-19 testing may succeed in targeting those who generate the largest social benefits from self-isolation if infected, which strengthens the case for widespread testing. covid-19 rapidly developed into a pandemic, and by 26 march 2020, the usa had the highest reported number of infected people in the world. a general message from public health experts is that effective control of the spread of covid-19 requires widespread medical testing (who, 2020) . the testing will serve to determine whether people are infected or not, and ideally also if they have been infected and have reached immunity status. three reasons motivate widespread testing. first, if a person learns that they are infected, they can take appropriate measures to reduce the probability of infecting others, such as the recommended 14-day self-isolation (harvard medical school, 2020) . second, the data provided by widespread testing will better inform the need for the current social distancing policies (e.g., sheltering at home, avoiding gatherings of 10 or more people, keeping at least 6 feet away from other people and temporarily closing schools, universities, daycare centers, major sports leagues, cultural events and public spaces) (stock, 2020) . third, testing provides data about the asymptomatic rate in the usa (the share of infected people who show no or very mild symptoms) and insight into how close americans are to developing herd immunity to covid-19. this information is useful in order to determine when and where it makes sense to relax these costly social distancing measures. while the usa has increased its capacity to conduct more testing, around 1.8% of the population had been tested by 30 april 2020 (covid tracking project, 2020) . the effectiveness of testing in controlling covid-19 depends largely on how the tests are conducted. the ideal scenario is to test everyone, but that is infeasible. a second-best scenario is random sample testing (stock, 2020) . but for random testing to be effective, all sampled people would either need to voluntarily agree to be tested (which is unlikely, as we explain) or be forced to do so (which is illegal in the usa). the third-best (and first-best feasible) strategy is voluntary random testing. this strategy, however, could lead to a systematic selection biaswe will only test those individuals who prefer to learn their health status regarding covid-19; a significant fraction of people might not want to know. these individuals might find that their private costs outweigh any social benefits from not infecting others. this implies that they might want to avoid testing. if their private costs include above-average opportunity costs of social interactions, then individuals who decline to be tested may also be disproportionately likely to become superspreaders. to understand why this might happen, consider the ongoing literature on willful ignorance of health information (also called strategic ignorance). while standard economic theory suggests people never ignore information that enables them to adjust behavior (stigler, 1961) , many new studies find that people willfully ignore medical diagnoses, even when such knowledge would enable them to adjust behavior to better accommodate their health condition (sharot & sunstein, 2020) . for example, we see willful ignorance in many people at risk for breast cancer (thompson et al., 2002) , alzheimer's disease (cutler & hodgson, 2003) , hiv (hightow et al., 2003) and huntington's disease (oster et al., 2013) . the study by ganguly and tasoff (2017) is particularly relevant: they observe people will avoid a costless test for herpesa disease for which there is currently no cure, but for which information is useful in that it helps adjust behavior. people have also been found to willfully ignore health risk information, such as calories in food (thunström et al., 2016; woolley & risen, 2018; sunstein, 2019; thunström, 2019; nordström et al., 2020) . willful ignorance of health outcomes is likely to arise when people are torn between what they think they should do and what they want to do (thunström, 2016; woolley & risen, 2018) , or when ignorance allows them to form optimal expectations (downplay the probability of a bad health outcome; oster et al., 2013; nordström et al., 2020) . for instance, a person may think she should eat healthy, but want to indulge in ice-cream-she might then choose to avoid learning about the exact amount of calories in the ice-cream in order to avoid either her inner pressure to reduce the ice-cream consumption or the guilt from consuming it despite being aware of the calorie content. in this paper, we explore self-selection in covid-19 testing in the usa. we examine if people willfully avoid getting tested for covid-19, and, if so, what individual or household characteristics and circumstances are associated with testing avoidance. given that random voluntary testing is not yet available in the usa, there are no observational data to rely on for our analysis. we therefore design a hypothetical randomized controlled trial (rct). we recruit a nationally representative sample of 1000 participants. the study entails two treatments, across which we vary information about the potential emotional cost of testing before asking if participants would agree or disagree to a financially costless covid-19 test. in the baseline treatment, we inform participants that if they are found to be infected, they are urged to self-isolate at home for 14 days. in the high-cost treatment, we tell participants that those who test positive are strongly urged to self-isolate, which may be in a self-quarantine site away from home. we assume the test itself is costless and that the only cost incurred from a covid-19 test is the recommended self-isolation for 14 days should the test come back positive. if people are concerned only with their private benefits and costs from taking a covid-19 test, those with large private benefits and low private costs from knowing that they are infected will be the most likely to get tested. private benefits are significant for people at elevated risk for severe health consequences if they contract the virus or with family members at higher risk, while private costs are low for those who generally live a solitary life, professionally and in private. we expect elderly and those who haveor have a family member that haspre-existing conditions to be more willing to test. furthermore, we expect those at the lowest risk of losing out financially (e.g., risk to labor income or health care costs) or emotionally from self-isolating (i.e., if they are introverts who attach a low value to social interactions) to be the most willing to get tested for covid-19. in contrast, if people are concerned only with social benefits and costs, we would expect those most at risk of exposing others to be the most likely to get tested (e.g., potential 'super-spreaders'; i.e., people with jobs that entail mixing with other people, people living in urban areas, young people and people who are extroverts and attach a high value to social interactions). people with the potential to be super-spreaders might be torn about learning whether they are infected by covid-19. both private costs and social benefits from being urged to self-isolate for the next 14 days (harvard medical school, 2020) might be high for this group, and so influence their testing decision in opposite directions. for example, consider the behavior of an extrovert who values social interactions highly. if unsure of being infected, the extrovert behaves just as if she is not infected (e.g., as found for huntington's disease, by oster et al., 2013) . self-isolation means this person needs to give up highly valued social interactionsa factor that might deter them from a voluntary test for covid-19. at the same time, their self-isolation provides particularly meaningful private and social health benefits from reduction in exposure to, and spread of, the disease. these benefits to learning whether they are infected might encourage them to voluntarily test. it is an open question if the benefits outweigh the costs, causing the extrovert to take a costless covid-19 test. similarly, imagine a store clerk who risks losing income if self-isolating for 14 days. the potential private loss of income would deter them from testing, while the social benefits from reducing disease spread would encourage taking the test. again, the decision to test becomes an open question. previous studies show that willful ignorance arises when prosocial behavior is privately costly (dana et al., 2007; conrads & irlenbusch, 2013; onwezen & van der weele, 2016; gigerenzer & garcia-retamero, 2017; grossman & van der weele, 2017) . in this study, we find that around 70% of people want to take a costless covid-19 test. as might be expected, people who worry more about their health are particularly likely to want to take the test. we also find that those most likely to want to take the test are those most likely to spread the virus if unaware of their infection, including young people and extroverts with a preference for socializing. extroverts might also be at the highest risk for being infected, but even when we control for personal risks (amount of social interactions and worry about own health), we find they are more willing to test. the ability to afford to self-isolate for 14 days does not seem to affect the willingness to test. our results suggest that there is a significant amount of selflessness in the decision to test; people appear to be highly concerned about the social benefits from testing for covid-19 and little concerned about private costs. in addition, we do not find the expected treatment effect of our experimental manipulation of the private cost to testing (i.e., the location of self-isolation (at home or in a facility away from home) does not seem to matter to the testing decision). our expectation was that willful ignorance would be higher if selfisolation might take place away from home, since we assume self-isolation away from home is perceived as more costly. one interpretation of the lack of expected treatment effect is that it lends further support to the idea that private costs play a negligible role in the decision to test for covid-19. our results matter because they underscore the value of widespread covid-19 testing, even if such testing cannot be done randomly. our findings suggest that widely available and costless voluntary testing will target rather than scare off those most likely to be 'super-spreaders'. to test people's willingness to take a financially costless covid-19 test, we designed a hypothetical field experiment. the experiment is a rct with a between-subjects design, consisting of two treatments. in the first treatment (treatment baseline), participants were told they would be urged to selfisolate at home, if having tested positive. in the second treatment (treatment high cost), they were told they might be urged to self-isolate at a special site away from home. participants (n = 1000) were recruited by the research firm qualtrics, and the sample was required to be nationally representative along the dimensions of gender, age, education, race, income and residential region (east, west, north or south). while the recruitment costs from qualtrics are higher than when recruiting from amazon mechanical turk or turk prime, qualtrics continuously quality checks participants, which enabled us to avoid many issues that may otherwise contaminate online panels (e.g., see chandler & paolacci, 2017; sharpe wessling et al., 2017) . participants received standard qualtrics compensation to participate in a survey. testing for the sequence of the experimental study was as follows: step 1: all participants were asked screening questions at the front end of the survey about their gender, age, education, race, income and region in order to ensure the sample met us national quotas for those characteristics. step 2: participants were asked whether they had already been tested for the covid-19. if 'yes', they were asked why they got tested, the outcome of the test, how many days prior to survey participation they had taken the test and if the test was costly. if 'no', they were randomized into one of the two treatments and asked about their willingness to take a test. specifically, if in treatment baseline, they received the following information: currently, us authorities are working to test more people for the coronavirus. legislators are urging people who test positive, i.e., are found to be infected by the virus, to self-isolate at home for 14 days. if in treatment high cost, they were instead told: currently, us authorities are working to test more people for the coronavirus. legislators are urging people who test positive, i.e., are found to be infected by the virus, to self-isolate for 14 days. some states have started building self-quarantine sitessites where people who have the virus would be isolated for 14 days. if people stay at those sites, it is easier to ensure they comply with the guidelines to self-isolate. thereafter, participants in both treatments were asked: if you were given the opportunity to take a coronavirus test for free within the next 3 days, would you take the test? default alternatives to get or not get information have been shown to affect observed choices of ignorance (grossman, 2014) . to avoid nudging participants toward any particular answer, there was no default alternative; participants needed to choose either "yes, i would take the test," or "no, i would not take the test." step 3: all participants were asked about their current level of social distancing (how many people outside their household they had been within 6 feet of in the last 3 days; how many gatherings with more than 10 people they had participated in; and self-assessed level of compliance with social distancing). they were also asked whether they supported the public recommendations for social distancing in general. step 4: participants were asked questions about factors that might affect the perceived cost of a positive covid-19 test (implying social isolation for 14 days), as well as the perceived benefits from being able to make behavioral adjustments. they were asked about their job situation, job security and possibility of the main income provider in the household taking sick leave; risk factors for contracting the virus (e.g., living in a urban area, working in a health care facility, working in a grocery store or pharmacy); risk factors (for self or any children) for suffering severe health consequences if contracting the virus (e.g., underlying health conditions that increases the risk, such as cancer, obesity, diabetes, etc.); level of extraversion (francis et al., 1992) ; and social lifestyle. step 5: participants were asked about religious belonging, religiosity, political affiliation and social and fiscal conservatism (everett, 2013) . the full survey can be found in the online supplementary material. of our total sample, 103 participants stated that they had already been tested, while 897 stated that they had not already been tested. we asked those who had been tested for the primary reason they had taken the covid-19 test. table 1 shows their answers. as expected, given the current prevailing strategy in the usa of focusing the limited testing on people who are symptomatic, most people got tested because they themselves showed symptoms (almost 55%) or because someone close to them either showed symptoms or was diagnosed with covid-19 (around 35%). summary statistics for the 103 participants who had been tested before participating in our study are shown in the online supplementary material. our analysis focuses on the 897 participants who stated that they had not been tested for covid-19. due to a coding error in the survey at the beginning of the data collection, seven participants did not respond to the question on whether they were a business owner, employed or unemployed. we dropped these seven participants from our analysis, and we were left with 890 observations. table 2 presents the summary statistics for these participants. unless otherwise stated, all of the remaining analysis focuses on the results for this group of participants. table 2 shows that 53% of participants who had not yet been tested for covid-19 are female. the variable age describes a participant's age in years, and the mean age in our sample is 47 years. the variable high-risk age is a dummy variable that takes the value 1 if a person is aged 65 years or older. table 2 shows that 16% of our participants are aged 65 years or older. the variable rural area takes a value 1 if participants stated that they live in a rural area and 0 if they live in an urban area. table 2 shows that 35% of our participants live in a rural area. the variables emotional tolerance and financial tolerance are dummy variables that take the value 1 if the participant answered that the maximum time (from the time of taking the survey) he/she would be able to emotionally or financially sustain social distancing was 14 days or longer, given the 14-day recommended time to self-isolate if you test positive for covid-19. these variables take the value 0 if their stated maximum time was 13 days or less. table 2 shows that 84% of participants stated that they can afford to continue their testing for covid-19 7 current level of social distancing for 14 days or more, while 87% stated that they can emotionally tolerate another 14 days or more of their current level of social distancing. the variable lifestyle impacthealthy is an index that measures the extent to which social distancing has changed participants' behavior in a healthier direction. participants were assigned a value 1 for each of the following: if they stated that social distancing had (a) increased consumption of vegetables, (b) decreased in-between-meals snacking (excluding fruits and vegetables), (c) increased time spent in green spaces, (d) increased time spent doing strenuous or (e) moderate exercising and (f) reduced stress. this variable could take a value between 0 and 6, where higher values represent healthier changes. the variable lifestyle impactunhealthy is an index that measures the extent to which social distancing has changed behavior in an unhealthy direction. participants were assigned a value 1 for each of the following: if they stated that social distancing had (a) decreased consumption of vegetables, (b) increased in-between-meals snacking (excluding fruits and vegetables), (c) decreased time spent in green spaces, (d) decreased time spent doing strenuous or (e) moderate exercising and (f) increased stress. this variable could also take a value between 0 and 6, where higher values represent a higher number of unhealthy changes. the summary statistics in table 2 suggest that social distancing has led to more unhealthy behavior than it has healthy behavior, as implied by the lower mean value of lifestyle impacthealthy. we note, however, that these variables are crude measures of the lifestyle impact from social distancing, where each change is given equal weight, although some changes might have a more important health effect than others. 1 the variable business impact takes a value 1 if a participant is a business owner whose business has experienced negative impacts due to covid-19, such as their operation losing income, going out of business or being at risk of going out of business. the variable employer impact takes a value 1 if a participant is an employee and his/her employer has experienced a negative impact due to covid-19, such as their employer losing income or being at risk for going out of business, if they had experienced pay cuts, reduced working hours or were on unpaid leave as a result of the virus. 2 table 2 shows that of participants who are business owners, or where until a month ago (n = 89), 64% had experienced a negative impact on their business from covid-19. of participants who are employees, or were until a month ago (n = 477), 57% had experienced a negative impact on their job security, payment or employer revenues. the variable social distant compliant -6 feet measures how many people a participant has been close to in the last 3 days. participants could state 'none', 1 person, 2-3 people, 4-5 people, 6-9 people, 10-15 people, 16-25 people, 26-50 people or 'more than 50 people'. we assigned participants the midpoint of the range they picked. for those in the highest range (50 and more), we assumed the same size interval as the second to highest interval (i.e., we assumed an endpoint of the last interval equal to 75 people). table 2 shows that the average number of people that participants had been close to during the last 3 days, besides their household members, was 5.76. although not reported in the table 2 , the median was 2.5. the variable social distant compliantgroups measures how many times during the last 3 days a participant has been in a room with 10 or more people. participants could state a value anywhere between zero and '5 or more times'. the median of this variable is 0. table 2 shows that participants on average had been in a room with 10 or more people around 0.5 times during the last 3 days. the variable self health risk measures the sum of 10 underlying health conditions that would put the participant at higher risk for developing severe health consequences if becoming infected with covid-19. these health conditions include chronic respiratory conditions, heart disease, neurological conditions, diabetes and obesity (cdc, 2020). the variable child health risk measures the same sum of underlying health conditions for a child in the household. the variable worry about own health is based on the stated extent to which participants worry about their own health due to covid-19, where the value 0 indicates 'not at all' and the value 3 indicates 'a lot'. the dummy variable insurance takes a value 1 if a participant states that he/she has private health insurance or is covered by medicare or medicaid and 0 if the participant stated not having any coverage. table 2 shows that 69% of participants have insurance or medicare or medicaid coverage. the dummy variables republican, democrat and other political party take a value 1 if a participant identifies as republican, democrat or neither, and 0 otherwise. about 34% of participants identify as republican, 43% as democrat and 23% as other. that they had been placed on unpaid leave; and 23% of workers said that they had had their pay reduced. the variable extrovert is based on the extraversion scale developed by francis et al. (1992) and includes participants' answers to questions such as "are you a talkative person?" and "can you easily get some life into a rather dull party?" in addition to the extraversion scale, we also asked participants to indicate their level of agreement with statements about their general social lifestyle, such as "my social life is very important to me," and "in my spare time, my favorite thing to do is to spend time with friends." if the participant answered yes to three or more of these questions, they were assigned a 1 for the extrovert dummy variable. the answers to these statements were, however, highly correlated with the extraversion scale, so they were excluded from our analysis because they provided little or no additional information. when we pool participants from both treatments who had not been tested prior to participating in our study (n = 897), we find that 69% of participants would be willing to take a costless covid-19 test. 3 we find no difference in shares of participants willing to test across treatments (pearson χ 2 (1.619); p = 0.203), suggesting that the location of self-isolation (at home or in a facility away from home), in the event the test comes back positive, is not an important determinant of people's willingness to test for covid-19. not only is the treatment effect small, it is also of the unexpected signthe share of people willing to test if self-isolation would happen at home is smaller (67%) than the share of people willing to test if self-isolation might happen at a facility away from home (71%). if anything, people might be slightly more inclined to test if a positive result could lead to isolation away from home (potentially due to this also signaling the greater severity of the covid-19 situation), but the size of the effect is too small for us to detect with our sample size. we have ruled out 3 participants who stated that they would prefer not to take the test (278/897) were asked for their reasons not to want to take the test. they were given the following alternatives and were asked to mark all that apply: "i would not change my behavior if i learned i had the virus" (11%); "i do not want to self-isolate for 14 days" (4%); "my job prevents me from self-isolating for 14 days" (6%); "i think i have already had the virus" (2%); "it would cause me emotional discomfort if i knew i had the virus" (7%); "it doesn't matter to me if i get tested or not" (30%); other (53%). the numbers in parentheses show the shares of participants who agreed with the statement. as shown, a large share of participants stated that the test would not matter, and that they would not change their behavior anyway. a potential reason for the prominence of these reasons could be that they are already highly complying with social distancing. (table 3 shows that the more people comply with social distancing, the less likely they are to want to take a covid-19 test.) however, a large share also states 'other', suggesting that the alternatives presented to our participants did not cover the full range of reasons as to why people may refrain from testing. we encourage future research to further explore these reasons. that this absence of identifiable average effect masks any potentially 'rational' heterogeneity in the population (i.e., we have explored whether there exists a treatment effect for subgroups of the population, such as those with children, higher-quality homes (as measured by income) or health anxiety (as measured by underlying health conditions)). one interpretation of the absence of treatment effect is that people assign little weight to the personal cost associated with the location of self-isolating when they decide on whether to take a covid-19 test. we pool participants from both treatments and examine the determinants of willingness to test. we estimate a probit model. table 3 shows the resulting average marginal effects. concerns about own health are captured by the variable worry about own health. the results in table 3 imply that the more a person worries about their health due to covid-19, the more likely they are to take a test. the inclusion of this variable in our model also renders the coefficient for the variable that measures underlying health conditions (i.e., self health risk) small and statistically insignificant (if worry about own health is excluded from the regression, self health risk has the expected positive, and statistically significant, effect on willingness to test). we do not find that people with children who have underlying health conditions are more likely to take the test, perhaps due to the expectation that people of young age are less affected. this result remains robust if we recode the variable child health risk into a dummy variable that takes the value 1 if any child in the household has one or more underlying health conditions. variables that affect a person's financial situation do not seem to matter to the willingness to take a covid-19 test. in particular, we do not find an effect from business impact or employer impact. we examine the robustness of these findings to alternative measures of business and employer impact. first, we instead include the multitude of variables underlying business impact and employer impact in the regression model (see footnote 2), but we do not find an effect from any of those variables that is close to statistically significant at even the 10% level. furthermore, we do not find an effect on willingness to test from financial tolerance. second, we recode the variables such that they range from little impact to severe impact (ranging from if a business owner or employee has experienced no adverse effects from covid-19, to one or multiple effects). again, we find no statistically significant effects from these variables on the willingness to test. taken together, these results suggest that people do not consider their own private costs from a positive test when deciding on taking a covid-19 test. similarly, we find no effect on the willingness to test from emotional tolerance, implying that the private emotional cost from social isolation in the event of a positive test might not affect the decision to take a covid-19 test. we find that healthy younger people are more likely to take a test than healthy older people, as implied by the negative parameter estimate for high-risk age. this age effect is consistent with findings in other studies that standard errors in parentheses. *p < 0.1, **p < 0.05, ***p < 0.01. observe older people avoid health-related information more than younger people (thunström et al., 2016; gigerenzer & garcia-retamero, 2017) . while this result could imply that older people are more likely to be willfully ignorant, it is also in line with the idea that those with more social interactions (younger people) are more likely to get tested. studies find that people below 60 years old have more social contacts, and therefore are more likely to transmit infectious diseases (mossong et al., 2008) . furthermore, we find that those who have met more people during the last 3 days are more willing to take the test, as suggested by the negative parameter estimate for social distance compliant -6 feet. furthermore, the potential 'super-spreaders'the extrovertsare more likely (by 8%) to take a test compared to the introverts. taken together, this suggests that social benefits weight heavily in people's decisions to test; those most at risk to spread covid-19 are the most willing to get tested. we find that republicans are 13% less likely than democrats to get tested. we speculate that this might be due to different information sources and because the risks of covid-19 might be portrayed differently in liberal and conservative popular and social media. we examined the robustness of this result by including a conservatism scale (everett, 2013) in the probit regression, and the result remains the same: people who are more conservative are less likely to want to take a covid-19 test. the conservatism scale is, however, not included in the final model, given its high correlation with the political dummy variables. finally, we find that people with health insurance, or coverage from medicare or medicaid, are around 8% more likely to take the test. this result might suggest that people who lack health care coverage use willful ignorance as a means to reduce anxiety about how to deal with a diagnosis. this would be in line with previous studies that suggest willful ignorance of health diagnoses may be motivated by the drive to reduce anxiety about the future (e.g., oster et al., 2013) . our results are robust to the inclusion of other explanatory variables, such as race, education, income and profession with high exposure to infected people (health care worker, store clerk, etc.). but these variables lack explanatory power or are highly correlated with other explanatory variables included in table 3 . the tests conducted prior to participating in our study were neither randomly offered to people (so far, testing for covid-19 in the usa has been primarily of individuals who showed symptoms), nor costless (52% of those who had tested prior to participating in our study stated the tests were financially costly and 60% said testing was time consuming). the value of data on observed testing is limited when it comes to helping us understand whether people might purposefully ignore such tests. while acknowledging that, we still compare our identified determinants of testing in table 3 to the determinants of having taken a test before participating in our study (see online supplementary material). while the levels of statistical significance vary, all coefficients are of the same sign as those in table 3 , except for four variables. having taken a test before participating in our study seems to be positively affected by having spent more time in groups with 10 or more people (i.e., social distance compliantgroups), as well as by a child having underlying health conditions (i.e., child health risk). employer impact has a (weakly) statistically significant positive effect on testing prior to participating in our study, while it is not statistically significant in table 3 . insurance is not a statistically significant determinant of having been tested prior to participating in our study, while it does have an effect in table 3 . widespread testing is one of the most important actions that us governments at any level can undertake to help slow down the spread of covid-19. given budget and testing supply constraints, it is likely that random, but voluntary, testing will be the most effective policy. we design a survey to examine the risks from self-selection into taking a covid-19 test. overall, we observe that around 70% of people would agree to a costless covid-19 test. we find that people who are more worried about their own health due to covid-19 are more likely to test, as are young healthy people, relative to older healthy people. ability to afford self-isolation for 14 days does not seem to affect the decision to test. furthermore, people who worry more about their health, and people with health insurance or health coverage through medicare or medicaid, are more likely to take the test, as are people identifying as democrats compared to republicans. contrary to our expectation, we also find that potential 'super-spreaders' are more likely than other individuals to agree to a costless covid-19. it could be that extroverts are more willing than expected to take a covid-19 test because their private cost of doing so is unusually low due to the broadly implemented social distancing at the time of data collection for this study. if extroverts are already relatively isolated (i.e., due to a stay-athome order and mandated closures by the state governor of public spaces, such as gyms, restaurants and bars), the personal cost of testing might be low. furthermore, extroverts might be more likely to get infected if they socialize more, which could be a 'selfish' motivation to get tested. however, we control for the current level of compliance with social distancing, which should address both of these private motivations for increased probability of testing, and we find that people who comply more are less motivated to take the test. we also control for their worry about own health due to covid-19. even so, the positive effect on willingness to test from being an extrovert persists. we therefore conclude that the positive effect of being an extrovert on willingness to test for covid-19 is likely due to social health benefits weighing more heavily in their decision than their private costs from potential self-isolation for 14 days, should the test come back positive. the importance of the prosocial motive in determining covid-19 testing is consistent with the results of the study by jordan et al. (2020) , who find that prosocial messages are more effective than self-interested messages in promoting behavior that prevent the spread of covid-19 (e.g., hand washing, hand shaking, hugging). our results suggest that the risks of adverse selection (in terms of failing to target the people most likely to spread the virus) in testing for covid-19 might be fairly low. this underscores the value of widespread testing, even if it cannot be truly random, and the importance of making such testing available nationwide in the usa as soon as possible. an important shortcoming of our analysis is that it builds on hypothetical survey data. it is well documented that survey answers may be affected by a 'hypothetical bias', meaning that people answer one way in a survey and behave in a different way when faced with real, incentivized decisions. this risk pertains to our study as well, and the hypothetical bias might be particularly pronounced if the choice to test for covid-19 is regarded as prosocial. several studies suggest that a hypothetical bias is particularly likely when measuring prosocial behaviorpeople often exaggerate the extent to which they engage in such behavior (e.g., murphy et al., 2005; vossler et al., 2012; jacquemet et al., 2013) . furthermore, it is possible that personal costs to the testing decision are less salient in a hypothetical context. once testing is more widespread in the usa, it will be important to examine who actually chooses to get tested, and the extent to which they deviate from the general population. that said, hypothetical and incentivized behavior generally correlate, such that an analysis like ours can provide important insights into the potential pitfalls of voluntary testing, prior to the actual testing. this is useful information to have on hand when designing an efficient and costeffective testing strategy. to view supplementary material for this article, please visit https://doi.org/10.1017/bpp. 2020.15 16 l i n d a t h u n s t r ö m e t a l . what you can do if you are at higher risk of severe illness from covid-19 lie for a dime: when most prescreening responses are honest but most study participants are impostors strategic ignorance in ultimatum bargaining most recent data to test or not to test: interest in genetic testing for alzheimer's disease among middle-aged adults exploiting moral wiggle room: experiments demonstrating an illusory preference for fairness the 12 item social and economic conservatism scale (secs)', plos one the development of an abbreviated form of the revised eysenck personality questionnaire (epqr-a): its use among students in england, canada, the usa and australia fantasy and dread: the demand for information and the consumption utility of the future cassandra's regret: the psychology of not wanting to know strategic ignorance and the robustness of social preferences self-image and willful ignorance in social decisions coronavirus resource center failure to return for hiv posttest counseling in an std clinic population preference elicitation under oath don't get it or don't spread it? comparing self-interested versus prosocially framed covid-19 prevention messaging social contacts and mixing patterns relevant to the spread of infectious diseases a meta-analysis of hypothetical bias in stated preference valuation strategic ignorance of health risk: its causes and policy consequences when indifference is ambivalence: strategic ignorance about meat consumption optimal expectations and limited medical testing: evidence from huntington disease how people decide what they want to know mturk character misrepresentation: assessment and solutions the economics of information random testing is urgently needed ruining popcorn? the welfare effects of information psychosocial predictors of brca counseling and testing decisions among urban african-american women strategic selfignorance welfare effects of nudges: the emotional tax of calorie menu labeling truth in consequentiality: theory and field evidence on discrete choice experiments closing your eyes to follow your heart: avoiding information to protect a strong intuitive preference report of the who-china joint mission on coronavirus disease we thank the stroock fund for financial support. this study was approved by the irb at university of wyoming and was pre-registered in the aea rct registry (rct id: aearctr-0005587). key: cord-256771-kweh1doo authors: williams, simon n; armitage, christopher j; tampe, tova; dienes, kimberly title: public perceptions and experiences of social distancing and social isolation during the covid-19 pandemic: a uk-based focus group study date: 2020-04-15 journal: nan doi: 10.1101/2020.04.10.20061267 sha: doc_id: 256771 cord_uid: kweh1doo objective: explore the perceptions and experiences of the uk public of social distancing and social isolation measures related to the covid-19 pandemic. design: qualitative study comprising five focus groups carried out online during the early stages of the uk's social distancing and isolation measures (5-12 days post lockdown). setting: online video-conferencing participants: 27 participants, all uk residents aged 18 years and older, representing a range of gender, ethnic, age and occupational backgrounds. results: the social distancing and isolation associated with covid-19 policy has had having substantial negative impacts on the mental health and wellbeing of the uk public within a short time of policy implementation. it has disproportionately negatively affected those in low-paid or precarious employment. practical social and economic losses the loss of (in-person) social interaction, loss of income and loss of structure and routine led to psychological and emotional 'losses' the loss of motivation, loss of meaning, and loss of self-worth. participants reported high adherence to distancing and isolation guidelines but reported seeing or hearing of non-adherence in others. a central concern for participants was the uncertainty duration of the measures, and their ability to cope longer-term. some participants felt they would have lingering concerns over social contact while others were eager to return to high levels of social activity. conclusions: a rapid response is necessary in terms of public health programming to mitigate the mental health impacts of covid-19 social distancing and isolation. initial high levels of support for, and adherence to, social distancing and isolation is likely to wane over time, particularly where end dates are uncertain. social distancing and isolation 'exit strategies' must account for the fact that, although some individuals will voluntarily or habitually continue to socially distance, others will seek high levels of social engagement as soon as possible. habitually continue to socially distance, others will seek high levels of social engagement as soon as possible. • adherence to non-pharmaceutical interventions during pandemics is lower where people have low trust in government and where people perceive themselves at relatively low risk from the disease • there is a need for evidence on public perceptions and experiences of the psychological and social public experiences of covid-19 related social distancing and isolation, and its relation to adherence. • people lack trust in government and perceive themselves at low personal risk,but closely adhere to social distancing and isolation measures motivated by social conscience, and are critical of non-adherence in others. • population-wide social distancing and isolation can have significant negative social and psychological impacts within a short time of policy implementation. • key concerns during social distancing and isolation are uncertainty of duration and ability to cope longer-term. • at the end of pandemic 'lockdowns', some individuals will likely voluntarily or habitually continue to socially distance, while others will likely seek high levels of social engagement as soon as possible. . cc-by-nc-nd 4.0 international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . the current coronavirus pandemic presents the greatest threat to public health in living memory and promises to be the deadliest pandemic since 1918-19. [1] [2] pandemics are challenging for clinical and public health agencies and policymakers because of the scientific and medical uncertainty that accompanies novel viruses like covid-19. [3] [4] since covid-19 is a new virus, pharmaceutical interventions like vaccines are not presently available. public health policy is therefore exclusively reliant on non-pharmaceutical interventions (npis). the key npis being used in relation to the covid-19 pandemic in the uk and globally (in addition to personal hygiene advisories (e.g. emphasising regular and thorough handwashing)) are social distancing (e.g. prohibiting public gatherings, closing schools and other non-essential services, and keeping a distance of >2 metres apart from others) and social isolation (e.g. remaining indoors except for one brief outing for per day for physical activity or 'essential supplies'). [5] due to the unprecedented scale and severity of the social distancing and social isolation measures being implemented in response to covid-19, the social and psychological impacts on the public are also likely to be unprecedented in scale and severity. a recent rapid review of the psychological impact of quarantine found that longer quarantine duration, infection fears, frustration and boredom, inadequate supplies, inadequate information, financial loss and stigma were among the major stressors. [6] another systematic review of the literature on npis in relation to pandemic influenza and sars found that people actively evaluate npis in terms of criteria such as perceived necessity, efficacy, acceptability and feasibility. [7] public views on social distancing and social isolation are ambivalent in some contexts because of their perceived adverse social and economic impacts and their ability to attract stigma, particularly amongst those required to self-isolate. [7] existing research on social distancing and isolation highlights a number of . cc-by-nc-nd 4.0 international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/10.1101/2020.04. 10.20061267 doi: medrxiv preprint challenges for public health policymakers, including a lack of trust in government; [8] concerns over strains in family resources; [8] gaps and confusions in some areas of pandemic information communication; [9] and low adherence to voluntary social isolation and relatively low adherence to non-attendance at public gatherings. [10] although there is existing research from past pandemics on its likely effects, [6] and new quantitative research is starting to emerge, [11] there is no published qualitative evidence on public perceptions and experiences of the psychological and social public experiences of covid-19 related social distancing and social isolation, and its relation to adherence -a gap that the present study addresses. this study aimed to explore four main questions: (1) what are the social and psychological impacts of social distancing and isolation experienced by the uk public during the covid-19 pandemic? (2) what are people's views on government communication around social distancing and isolation? (3) what are people's current experiences of adherence in relation to social distancing and isolation? (4) what are people's views on the future in regard to covid-19 social distancing and isolation. this study therefore aims to contribute to knowledge of adherence to social distancing and isolation policy to provide insight into how communication with the public on social distancing and isolation may be shaped and improved in the future. five online focus groups with 27 participants were run between march 28 th and april 4 th , 2020 (5-12 days after lockdown commenced on the 23 rd march 2020). participants were adults aged 18 years or over currently residing in the uk. under normal circumstances, online focus groups can be a useful way of eliciting public views related to matters of health and medicine, particularly from diverse and geographically dispersed participants [12] [13] but were necessary due to social isolation policy. . cc-by-nc-nd 4.0 international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/10.1101/2020.04. 10.20061267 doi: medrxiv preprint purposive sampling was used to provide a diverse range of ages, genders, race/ethnicities and social backgrounds and to explore the study's research questions. [14] [15] potential participants were asked to complete a very brief demographic survey to provide background information and to facilitate recruitment of a diverse population (table 1) . due to social distancing measures, it was necessary for all recruitment to be conducted online. researchers used a combination of social media snowball sampling, online community and volunteer advertising sites and social media advertisements (facebook ads). to ensure that online discussion was manageable, focus groups were kept to between 5-8 participants. each group met virtually via a web video-conferencing platform (zoom) for between 60-90 minutes. participants joined using both video and audio. all focus groups were organised and moderated by sw (a medical social scientist). the topic guide for the focus groups was initially developed using existing literature on public attitudes and experiences in past pandemics and was tested and refined in a pilot focus group. the main topics for the focus groups were: general views on social distancing and isolation; health impacts of social distancing and isolation; views on government covid-19 advice and communication; and views on compliance with, and the future impacts of, social distancing and isolation. . cc-by-nc-nd 4.0 international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/10.1101/2020.04. 10.20061267 doi: medrxiv preprint analysis data collection and analysis followed an iterative process, whereby emergent themes from early focus groups were used to add to or refine questions and prompts during subsequent focus groups. all focus groups were recorded and transcribed for coding. sw and kd analysed the transcripts and developed and applied the thematic coding framework. themes were discussed and developed with cja and tt during virtual research group meetings. to help analysis we looked to validate "sensitive moments" between groups that indicated difficult but important issues. [16] negative case analysis was used to seek for information that did not fit emergent themes, and where this occurred, themes were modified accordingly. [17] . following a grounded theory approach, data were organised into primary and more focused codes that provided insight into identified themes. [14, 18] data collection and analysis continued until saturation occurred (that is, until no new significant themes emerged). [18] data were analysed in nvivo (version 11.4.3, qrs). all participants felt that the social distancing and isolation polices had had significant social and psychological impacts on their lives and the central theme was loss (box 1). this . cc-by-nc-nd 4.0 international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/10.1101/2020.04. 10.20061267 doi: medrxiv preprint experience of loss, which one participant likened to a process of "grieving" (participant 25, male, age 58, london), consisted of three practical social and economic losses: loss of (inperson) social interaction, loss of income, and loss of structure and routine. these in turn led to three psychological and emotional "losses": loss of motivation, loss of meaning, and loss of self-worth. first, participants spoke of a loss of social interaction. the suddenness and extensiveness of the lack of face-to-face contact had, even after only one week of lockdown, already "taken its toll on mental health" (participant 2, male, age 31, manchester), leaving participants feeling "alienated" (participant 6, male, age 20, london). a number talked about feeling depressed or anxious as a result of social distancing or isolation, an experience some likened to "a prison" (participant 8, female, age 40, london). second, a number of participants discussed how a loss of income, either through permanent loss of a job, or through temporary loss (via lost clients or customers or being furloughed), had left them feeling "quite depressed" (participant 8, female, age 40, london). third, participants expressed of a loss of structure and routine. the inability to go to work, or for some the significant re-structuring of work patterns, including balancing home working with home schooling, meant that participants felt "overwhelmed" (participant 9, female, age 34, london). participants discussed how impacts like losing their job or not being able to go to work, and not being able to socialise with friends, meant they experienced a general loss of meaning in life. one participant already felt in need of professional mental health support, less than two weeks into isolation. participants also spoke of a loss of motivation to perform basic everyday tasks, such as personal hygiene and grooming or exercising. for some, this lack of motivation had left them feeling "sluggish" (participant 5, male, age 26, london). finally, participants expressed feeling a loss of self-worth. these emotional and . cc-by-nc-nd 4.0 international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/10.1101/2020.04. 10.20061267 doi: medrxiv preprint psychological losses were particularly acute for those living in more urban, densely populated cities like london or birmingham. they were also especially evident amongst those in lowpaid or precarious occupations, who had either lost their job or income or were now relying on parental, familial or state financial support as a result of the pandemic. "i'm literally planning day-to-day as things go along. … i'm not used to having the kids every . cc-by-nc-nd 4.0 international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/10.1101/2020.04. 10.20061267 doi: medrxiv preprint single day because they are usually at school. it's difficult to work around them, i can't do anything with them, because i can't go out. i feel so scared and don't want to risk it." (participant 9, female, age 34, london) "all this talk about social distancing and things is so depressing, terrible, i mean i have even been contemplating on contacting the samaritans just to be able to try to get through all this." (participant 10, male, age 44, london) "being locked in a room trying to find something meaningful to do during the day, and i think it's had a severe impact … i hope something changes within a few weeks, so i am able to go out and live a fulfilling life" (participant 1, male, age 30, birmingham) "physically it has had a toll on people. all day you are stuck at home. you eat, you sleep, you work, its gonna have an effect on the body, there is no real drive or motivation." (participant 6, male, age 20, london) "we are feeling very down and demotivated, very low very depressed to some extent… it's become more stressful to get by and function on a daily basis." (participant 1, male, age 30, birmingham) "your self-worth goes down a bit, because you can't socialise with people and make yourself feel good about yourself." (participant 2, male, age 31, manchester) "the company i work for has closed down and i have had to apply for welfare assistance … and i've had to go and live with my parents now, and they have had to support me financially. … it's . cc-by-nc-nd 4.0 international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/10.1101/2020.04.10.20061267 doi: medrxiv preprint been difficult, the whole mental health, the ability to function and get by, and being constantly locked in." (participant 1, male, age 30, birmingham) most participants felt that guidance on social distancing and isolation had been generally unclear, although some described how it had "become clearer" over the course of the pandemic (participant 7, male, age 20, glasgow) (box 2). many participants exhibited a lack of trust either in government, who were seen to be "politicising" the pandemic (participant 22, male, age 51, north-west england), or in the media, who they felt were providing confusing information or "mixed messages" (participant 1, male, age 30, birmingham). participants felt that despite being locked at home, the constant media and social media attention on covid-19 made them feel "claustrophobic in both a physical and an emotional sense" (participant 5, male, age 26, london), and that "seeing others in a heightened state of anxiety makes it harder to suppress that in yourself" (participant 21, female, age 46, north west england). another common criticism was over the ambiguity of terms such as 'essential' and 'emergency' supplies and services. this ambiguity, participants argued, meant that advice was either hard to follow or implement, or that "loopholes" could be exploited (participant 19, female, age 21, south wales) (see section below on compliance, non-compliance and the future). mixed or unclear messages . cc-by-nc-nd 4.0 international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/10.1101/2020.04.10.20061267 doi: medrxiv preprint "after reading several news publications and channels, there has been much campaign around social distancing, and with isolation you normally associate it when you have got the virus yourself, but i think over the past week there have been several mixed messages over social distancing." "now everyone has been told that they have to stay in their houses, and people are thinking well 'this can be classed as essential, and this can be classed as essential, whereas although we have been told a list of things we can do, people are finding loopholes and finding ways to get round them" (participant 19, female, age 21, south wales) "i have seen loads of people outside, and i wonder how people will enforce that [penalty fines for not social distancing], i'm wondering how can someone prove they are going for an 'emergency reason'?" (participant 2, male, age 31, manchester) all participants reported being highly adherent to government instructions on social distancing (box 3). participants described how, despite the perceived lack of clarity discussed above, they had been social distancing and isolating as far as possible. participants also displayed a high degree of social consciousness, with many acknowledging that despite . cc-by-nc-nd 4.0 international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/10.1101/2020.04.10.20061267 doi: medrxiv preprint not perceiving themselves as being at high risk, they were doing it to "save lives" and protect those most vulnerable to the disease. despite reporting their own high degree of adherence, many participants suggested that they had seen instances of non-adherence in others. observations of non-adherence were associated with three main factors. first, non-adherence was seen to be due to a lack of social conscience. participants were generally critical of what they perceived to be a minority of "inconsiderate" (participant 27, female, age 46, london) or "arrogant" (participant 17, male, age 22, south wales) individuals who were not observing instructions related, for example, to public gatherings and not keeping a distance of >2 metres apart from others when out for daily walks or runs. second, non-adherence was seen to be due to a lack of understanding. for example, participants argued that people who were not observing social distancing lacked knowledge over how they could help spread the disease even if they themselves were not exhibiting symptoms. third, non-adherence was seen to be due to a lack of enforcement. many participants were critical that police were choosing to enforce social distancing restrictions or were not able to (due for example to the ambiguity of terms such as "essential" as discussed in the previous section). others discussed how, despite their best efforts, supermarkets appeared to struggle to implement social distancing. high levels of support for, and adherence to social distancing and isolation . cc-by-nc-nd 4.0 international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/10.1101/2020.04.10.20061267 doi: medrxiv preprint non-adherence due to lack of social conscience "i'm worried that people are going to take advantage of the nice weather and ruin it for people … its insane because they have shut the park, but you get some inconsiderate people like a group of lads playing football or people taking over the paths." (participant 27, female, age 46, london) "the canal path we walk along is not 2 metres wide, but you can just about get around it if you go on the verge and they go on the verge, and most people do but not everybody does … i don't say anything because … with all the publicity that's out, if you are still choosing to do that, then me telling you not to do it is not going to make a difference, it's frustrating" (participant 26, female, the vast majority of people are taking it seriously and suffering to a certain extent, but there is a minority who don't necessarily understand it applies to them also. i know of people who have gone to parks or gone for a picnic, because they think 'well we don't know anyone who has any symptoms, and we've not got anything, so we can go about it in the same way'." (participant 19, female, age 21, south wales). "they say that you are not allowed to go out for non-emergency reasons, which i don't think a lot of people are observing. people are just going out whenever they want. those guidelines are in place by boris [johnson; uk prime minister] but no-one is really enforcing that. you see police on the street, but they are not really doing anything." (participant 2, male, age 31, manchester) "the supermarket they are not implementing, what's the point in having the two-metre thing outside when you can't do that inside. … i went to the supermarket and people respect it outside, . cc-by-nc-nd 4.0 international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/10.1101/2020.04. 10.20061267 doi: medrxiv preprint but as soon as you go inside there is [sic] people, they don't care, they just come right up to you and try to reach over you." (participant 8, female, age 40, london). according to participants, "the biggest problem we've got is we don't know when it's going to end" and the sense of "powerlessness" this had fostered (participant 25, male, age 58,). despite their high level of current adherence, participants acknowledged there was a limit as to how long they and others could adhere, at least without experiencing more severe social and psychological suffering. some participants felt that they would rather be told a specific time frame, even if it was far in the future. others feared that whilst they and others could "get through" this initial phase of lockdown, going "in and out" of periods of lockdown (a scenario some knew was possible due to the potential for covid-19 to re-emerge in a second wave) meant that "people will really struggle mentally" (participant 19, female, age 21, south wales). some felt as though they could only take things "day-by-day" because anticipating social distancing and isolation over a period of time was "too overwhelming" (participant 22, male, age 51, north-west england). looking to the future, participants were divided as to how they felt they, and others, would act when social distancing and isolation measures were either relaxed or removed. some felt that they and others would "go back to living my life completely as normal" (participant 24, male, manchester) as soon as possible. these participants spoke of "being desperate to go out and go to restaurants or travel a lot" (participant 5, male, age 26, london) and generally not taking a graded approach to social reintegration. they argued that if they were "told its ok" to socially reintegrate, then this was enough for them to "not feel too anxious about going out with friends in the future" (participant 24, male, age 40, north-west england). others felt that it would take them a longer to return to pre-pandemic social . cc-by-nc-nd 4.0 international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/10.1101/2020.04. 10.20061267 doi: medrxiv preprint behaviours, and for example felt that they would continue to have "anxiety around health" (participant 23, female, age 38, north-west england), would be "cautious" about a "transition period where i stay in a bit more" (participant 2, male, age 31, manchester) and that people in general might remain "socially distant" from one another (participant 8, female, age 40, london). others argued that how they would act would likely depend on the circumstances under which social distancing and isolation measures were being relaxed or removed. specifically, this was tied to their perception of whether covid-19 still posed a risk to them or to society in general. they argued that, if a vaccine was available, then they would be happy to return to their pre-pandemic activity. the challenge of future uncertainty "i would rather they [the government] said tonight, 'you're gonna be stuck in your houses until september, than say, we will review in three weeks, and then say, we will review in three week, and keep doing that, i'd rather they set a date way in advance in the future because then you can get your head around it" (participant 17, male, age 22, south wales) "i've heard on the grapevine and online sources that we are in this lockdown for a few weeks or so, and then after 12 weeks or so we kind of get released and because we are not all immune necessarily it all comes back in a wave and then we have this constant thing of being locked down and then coming out and going back in again, … and so i think it will go downhill, that's when people will struggle mentally because they've had that taste of freedom, and you don't know how long it's all going to finish." (participant 19, female, age 21, south wales) . cc-by-nc-nd 4.0 international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/10.1101/2020.04. 10.20061267 doi: medrxiv preprint perceptions of future behaviour "i'm literally thinking day-by-day, because if one was to consider three months of this, and we are only two weeks in, it's just too much, it's too overwhelming" (participant 22, male, age 51, north-west england) "people are not going to stay like this for another 6 months. it's for a good reason i know, but it's like a prison, we know what people are suffering mentally and emotionally, we don't know what people are going through behind their door … when all this comes to an end we don't know how life is going to be. is everybody going to be socially distant? it's scary." (participant 8, female, age 40, london) although the findings discussed above represent the most common views exhibited by participants, negative case analysis did reveal some alternative accounts. for example, some participants argued that social distancing and isolation "hadn't been hard" (participant 17, male, age 22, south wales). however, these participants were all university students, and acknowledged that part of the reason it hadn't been as difficult for them was there had been no loss of income and, less loss of routine for them. a small number of participants argued that they were able to draw positives from the social distancing and isolation due to covid-19. for example, some described how household quarantine had meant they could have "more time with their children" (participant 14, male, age 38, north-west england) or had brought family units together (participant 22, male, age 51, north-west england). however, those participants who explicitly discussed . cc-by-nc-nd 4.0 international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/10.1101/2020.04. 10.20061267 doi: medrxiv preprint the positives to be drawn from social distancing and isolation were all from higher socioeconomic backgrounds, and tended to live in more rural or less densely populated areas of the uk. our findings suggest that a large proportion of the uk public may be suffering from feelings of depression, anxiety, and loss as a result of covid-19 social distancing and isolation. some already feel in need of professional mental health support. the social and psychological impacts identified through this study centred around the various losses that people are experiencing. practical social and economic losses -the loss of (in-person) social interaction, loss of income and loss of structure and routine -led to psychological and emotional losses -the loss of motivation, loss of meaning, and loss of self-worth. findings also suggest that participants generally found information on social distancing to be ambiguous. however, there were differing views as to whether the government was at fault (insufficiently clear communication) or that the terms themselves are ambiguous and a small minority of the uk public were taking advantage of the ambiguity. it was recognized that this ambiguity may have been designed to permit greater social freedom than the more extreme social distancing and isolation measures implemented in other countries. additionally, there was universally high adherence to social distancing and isolation guidelines reported across the study sample, yet most participants had observed or heard of non-adherence in others. participants were highly critical of such instances of nonadherence, citing lack of social conscience, lack of understanding and lack of enforcement as likely causes. perhaps the greatest concern for participants was the uncertainty they faced over the duration of the social distancing and isolation measures, as well as their ability to cope longer-term. there was also uncertainty as to how they and others would act, with some . cc-by-nc-nd 4.0 international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/10.1101/2020.04. 10.20061267 doi: medrxiv preprint fearful of lingering inhibitions and anxiety over social contact and health, and others eager to return to normal levels of social activity. our findings on covid-19 social distancing and isolation support some of the findings from existing systematic reviews on previous pandemics related to influenza and sars. [6] [7] for instance, we found that frustration or anxiety over loss of social interaction or loss of income, inadequate or ambiguous information, and fears over the duration of social distancing and isolation measures were all major themes. [6] [7] [8] . however, contrary to previous research which suggests that adherence with pandemic npis is lower in instances where people have low trust in government and where people perceive themselves at relatively low risk from the disease, [7] our participants were highly adherent to social distancing and isolation measures, despite many lacking trust in government and perceiving themselves at low risk. in fact, stigma was more likely to be attributed to those who were failing to socially distance and isolate. of course, as noted above the scale and severity of the pandemic and subsequent measures are unprecedented. as such, although there is existing research on its likely effects, [6] and although quantitative research is starting to emerge, [11] there is to, our knowledge, no published qualitative evidence on public perceptions and experiences of the psychological and social public experiences of covid-19 related social distancing and isolation, and its relation to adherence -a gap this study addresses. one limitation of this study is that it is not possible to rule out that the high degree of adherence and social conscience that participants expressed was not at least partly affected by social desirability bias, which can often be encountered in focus group studies. [19] however, . cc-by-nc-nd 4.0 international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/10.1101/2020.04. 10.20061267 doi: medrxiv preprint conducting focus groups online has been found to reduce social desirability bias (although it is worth noting that this is more so where asynchronous or text-only communication is used, and not video-conferencing as in our study). [12, 20] another limitation of this study is that it did not recruit participants who are deemed at particularly high risk from covid-19-related complications, for example, individuals aged 70 and over and those living with certain chronic health conditions. [21] because these individuals are likely to have been significantly affected by social distancing and isolation policy (being required to self-isolate for 12 weeks), their views will be important. it is also worth noting that our recruitment material did encourage those at high risk to apply, though we received no applications from those over-70. this may be partly due to the fact that those over-70 are a hard-to-reach group online, because they are significantly less likely to use social media or be heavy internet users, [22] which, due to the lack of online social support and interaction, might mean they are at particularly high risk of some of the negative social and psychological impacts discussed in this paper. future research will explore at-risk groups' experiences in depth. future papers will also explore further the similarities and differences in views and experiences in the perceptions of experiences of participants living in different parts of the uk (e.g. london compared to less densely populated areas), a theme only briefly discussed here due to limitations of scope. this study suggests that the social distancing and isolation associated with covid-19 policy is having substantial negative impacts on the mental health and wellbeing of the uk public within a short time of policy implementation. the prevalence of covid-19-related depression and anxiety, and the extent to which it will last beyond the removal or relaxation of social distancing and isolation policies remains to be seen. our ongoing research will . cc-by-nc-nd 4.0 international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/10.1101/2020.04. 10.20061267 doi: medrxiv preprint explore these social and psychological impacts longitudinally. policymakers and the public health community must discuss measures to respond to the likely wave of mental ill-health which is expected to follow, and which is tentatively suggested by our early qualitative evidence. the theme of loss and addressing public concerns around physical and emotional losses (e.g. meaning and self-worth), may inform current and future therapeutic interventions. loss of meaning and self-worth may be due in part to loss of control, and increasing a sense of control for the public should be considered in future policy, intervention, and programming. [23] additionally, findings suggest that a rapid response is necessary in terms of public health programming to mitigate these mental health impacts. waiting until restrictions and isolation measures are relaxed or removed to provide support services could potentially have devastating impacts. government and the public health authorities should look at ways of extending mental health outreach services, especially remotely. [24] timely attention is needed for those who are predisposed to depression and anxiety, those who may be suicidal, and those experiencing significant social, economic and personal loss. our study also suggests that although the covid-19 pandemic has had significant ramifications for many uk residents from diverse backgrounds, it has disproportionately negatively affected those in low-paid or precarious employment. future research and policy should therefore seek to develop measures that specifically seek to remediate the social, economic and psychological harms related to covid-19 as experienced by those from disadvantaged backgrounds. looking ahead to later stages in the current pandemic, or to the development of pandemic preparedness programmes for the future, a couple of lessons can be distilled, which warrant urgent attention. firstly, initial high levels of support for, and adherence to, social distancing and isolation measures are likely to wane over time, particularly where end dates are and remain uncertain. secondly, in planning the 'exit strategy' for the uk lockdown, and its possible impact on future resurgences of covid-19 . cc-by-nc-nd 4.0 international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/10.1101/2020.04. 10.20061267 doi: medrxiv preprint prime ministers impact of non-pharmaceutical interventions (npis) to reduce covid-19 mortality and healthcare demand plausible uncertainty": the negotiated indeterminacy of pandemic influenza in the uk the uk's policy conveys a false sense of scientific certainty and places too much responsibility in the hands of the public guidance on social distancing author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint the psychological impact of quarantine and how to reduce it: rapid review of the evidence public perceptions of non-pharmaceutical interventions for reducing transmission of respiratory infection: systematic review and synthesis of qualitative studies listen to the people": public deliberation about social distancing measures in a pandemic knowledge and attitudes of university students toward pandemic influenza: a cross-sectional study from turkey non-pharmaceutical interventions during an outbreak of 2009 pandemic influenza a (h1n1) virus infection at a large public university knowledge and perceptions of covid-19 among the general public in the united states and the united kingdom: a cross-sectional online survey online focus groups as a tool to collect data from hard-to-include populations: examples from pediatric oncology a 21 st century citizens' polis: introducing a democratic experiment in electronic citizen participation in science and technology decision-making rigor and qualitative research qualitative research: introducing focus groups author/funder, who has granted medrxiv a license to display the preprint in perpetuity. is the (which was not peer-reviewed) the copyright holder for this preprint developing focus group research: politics, theory and practice qualitative research: theory, method and practice making sense of qualitative data. london: sage understanding communication processes in focus groups researching online populations: the use of online focus groups for social research advice for everyone: coronavirus (covid-19) diversity in older adults' use of the internet: identifying subgroups through latent class analysis facilitating health behaviour change and its maintenance: interventions based on self-determination theory. the eur health psychol a case of misalignment: the perspectives of local and national decision-makers on the implementation of psychological treatment by telephone in the improving access to psychological therapies service infection, policymakers and public health authorities need to account for the fact that, although some individuals will voluntarily or habitually continue to socially distance (graded social reintegration) others will seek immediately to re-integrate fully beyond what they are permitted to.health serv res. 2019;19:997.. cc-by-nc-nd 4.0 international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity.is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/10.1101/2020.04. 10 . cc-by-nc-nd 4.0 international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity.is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/10.1101/2020.04. 10.20061267 doi: medrxiv preprint data sharing statement: ethical restrictions related to participant confidentiality prohibit the authors from making the data set publicly available. during the consent process, participants were explicitly guaranteed that the data would only be seen my members of the study team.for any discussions about the data set please contact the corresponding author, simon williams (s.n.william@swansea.ac.uk). committee.. cc-by-nc-nd 4.0 international license it is made available under a author/funder, who has granted medrxiv a license to display the preprint in perpetuity.is the (which was not peer-reviewed) the copyright holder for this preprint . https://doi.org/10.1101/2020.04. 10.20061267 doi: medrxiv preprint key: cord-266239-l0ulr2ep authors: freeman, shannon; marston, hannah r.; olynick, janna; musselwhite, charles; kulczycki, cory; genoe, rebecca; xiong, beibei title: intergenerational effects on the impacts of technology use in later life: insights from an international, multi-site study date: 2020-08-07 journal: int j environ res public health doi: 10.3390/ijerph17165711 sha: doc_id: 266239 cord_uid: l0ulr2ep as the use of technology becomes further integrated into the daily lives of all persons, including older adults, it is important to investigate how the perceptions and use of technology intersect with intergenerational relationships. based on the international multi-centered study technology in later life (till), this paper emphasizes the perceptions of older adults and the interconnection between technology and intergenerational relationships are integral to social connectedness with others. participants from rural and urban sites in canada and the uk (n = 37) completed an online survey and attended a focus group. descriptive and thematic analyses suggest that older adults are not technologically adverse and leverage intergenerational relationships with family and friends to adjust to new technologies and to remain connected to adult children and grandchildren, especially when there is high geographic separation between them. participants referenced younger family members as having introduced them to, and having taught them how to use, technologies such as digital devices, computers, and social networking sites. the intergenerational support in the adoption of new technologies has important implications for helping older persons to remain independent and to age in place, in both age-friendly cities and in rural communities. the findings contribute to the growing literature in the fields of gerontology and gerontechnology on intergenerational influences and the impacts of technology use in later life and suggest the flexibility and willingness of older persons to adopt to new technologies as well as the value of intergenerational relationships for overcoming barriers to technology adoption. from monitoring personal health and wearable devices to playing online games and using social media to connect with friends and family, technology has become a valued component of daily life for many individuals. interest in technology has steadily increased over the past decade, associated with unprecedented growth and innovation in information and communication technologies (icts) [1, 2] . there has been an increase in the proportion of older adults (persons aged over 65 years) in countries across the world utilizing technology [3] . as the use of technology and associated icts increases, there is a greater need to expand the understanding of the intersection of technology, ageing, and intergenerational relationships. a particular gap in knowledge exists regarding the role of intergenerational elements in motivating older adults to learn how to use technology and associated icts. across the globe, societies are aging rapidly due to increased life expectancy as a result of better health and social care, and lower birth rates [4] . recent united kingdom (uk) population estimations suggest the proportion of those aged 65+ years in rural and urban environments will increase by 50% between 2016 and 2039, whilst those aged <65 years are projected to increase by eight percent in urban areas and to stagnate in rural locations [5] . in 2014, 15.6% of the canadian population, equating to over 6 million persons, were aged 65, and it is predicted that by 2030, older adults will exceed 9.5 million persons, accounting for 23% of the canadian population [6] . in canada, the majority of older adults (56.4%) lived with a spouse or a common-law partner in 2011 while about one-quarter (24.6%) lived alone [6, 7] . the increase in the migration of younger cohorts from rural to urban areas and of older adults from urban to rural areas leaves an increased proportion of older adults in rural areas who prefer to "age in place" [8, 9] . research focused on aging in urban areas has emphasized the challenges older adults face in accessibility, especially in access to public transportation, shopping, and green space [10] . as geographic separation between family members increases, the role of icts in helping to strengthen and maintain family bonds becomes more important [11] . however, the extent to which older adults use technologies for this purpose remains unclear. although, in the future, aged cohorts may be more "tech savvy" [12] , having used technologies regularly across their life course, new technologies may still arrive that could be disproportionately challenging for older people to adopt. technology (e.g., digital devices, the internet, digital gaming, and mobile apps) use in later life is a growing field of research, with much new exploration and study [13] [14] [15] [16] . technology and associated icts are often aimed towards improving the health, wellbeing and quality of life of older adults, whether through applications for home healthcare and connected health services [17] , medication reminders [18, 19] , mirrors that display health data [20] , or wearable technology [21] . technology use to enhance communication is routine practice for many older adults, with home computers being used to create a common interest among older and younger family members and improve family ties [22] . technology use among older adults is growing [3] . for example, in canada, between 2007 and 2016, internet use increased from 32% to 68% among those aged 65 and older [23] . in 2016, 85% of people aged 65-69 used the internet compared to 62% of those aged 70-79 and 40% of those aged 80 years and older [23] . challenges with technology have been linked to age, evidenced by differences in use [24, 25] and variation in the learning of technology (computers and internet) between older and younger adults [12, [26] [27] [28] [29] [30] [31] . older adults in canada were less likely than younger adults to perceive technology as useful for communicating with others, making informed decisions, and saving time [23] . several studies reported that internet use is lower among older-aged cohorts than younger cohorts [32] [33] [34] ; however, there is evidence of a cohort effect as there has been an increase in technology use within older-aged cohorts over time [2] . older adults who do use the internet report lower confidence in their ability to do so than younger adults [35] , which may be tied to challenges older adults experience with technology use (e.g., visual difficulties and cognitive declines) [36, 37] . older adults are likely to make more errors and require assistance when learning computer systems and software [36, 37] . previous research suggests that older adults may be "technophobic" [38, 39] and struggle to use technology [2] , as they embrace technology differently and at a slower pace than younger adults [2] , [32, 40] . as the canadian and uk populations age, differences in technology adoption and use across age cohorts may increase, amplifying the "generational gap" [41] . while learning to use technology serves as a rite of passage for today's youth, playing an important role in the self-definition of young adults [42] , this may not be the case for older generations. individuals not born into the current rapidly evolving digital age, sometimes referred to as "digital immigrants", must find ways to adapt to a changing society [43] . rama noted that each "technology generation" may have been affected by common experiences during their formative years that influence behaviours towards and the use of technology [44] . however, these notions are challenged by bennett and maton, who note the diverse range of experience and engagement with technology among youth, as well as by loos, who describes technology use as a spectrum affected not only by life stage but also by socialization and degree of age-related functionality [16, 45] . technology use is complex and can no longer simply be split into user vs. non-user groups. instead, the heterogeneity in the use of technology includes not only use of the technology for an intended purpose but also the meaning and value that the use of technologies has in mediating social relationships and connection to the external world [46] . existing research highlights differences in technology use between the generations; however, research on the connection between intergenerational factors, social variables, and technology use among older adults is less prevalent, with notable exceptions including [26] [27] [28] . however, other research suggests that age is not a consistent driving factor associated with aversion to technology such as computer anxiety [24] . as such, it remains less clear how factors such as intergenerational intelligence, solidarity, and adaptiveness apply to the learning and use of technology, especially by older adults [47] [48] [49] [50] [51] . younger generations are the dominant early users and adopters of social networking sites [12, 52] , with few older adults (between 10% and 27%) using this form of technology [2, 3] . social networking and other technologies present opportunities for older generations to connect with younger generations and individuals in diverse geographic locations [22, [53] [54] [55] . technology has been shown to enhance an older adult's quality of aging [56] , independence [57] , social status [56] , interpersonal relationships, control, self-esteem, and integration into society [57, 58] . to understand how to meet the needs of an aging population in a technology-suffused society, it is useful to understand why older adults choose (or not) to use technology and whether (or not) they perceive the reasons driving their choice as constraints requiring negotiation or benefits to everyday life. the challenges to acquiring new technology skills and strategies for connecting with younger generations to overcome them suggest the importance of intergenerational influences on older adults' understanding and use of technology, which must be further explored. the above findings are concerning in light of research reports that older adults are more likely to experience loneliness and isolation [34] . there is, to date, a growing body of scholarly work exploring the relationships between intergenerational relationships and technology [27, 28] , offering insight into how technology and associated icts lay within and across intergenerational networks. taipale and colleagues [27] discuss ict use through various lenses including both older and younger adults-a generational perspective, the family, and the home. to further extend research in this area, we describe further the relationship between technology use and interpersonal relationships-more specifically, the how older adults' understanding and use of technology is affected by their intergenerational relationships. the technology in later life (till) study examined the experiences of older adults aged 70+ years with technology, exploring how they adopted, accepted, and used various types of technology. subsequently, the team sought to identify the implications of using icts for current and future aging populations in rural and urban locations. the technology in later life (till) study was an exploratory study conducted in canada and the uk across four study sites. canada and the uk were selected for this study as they both have aging populations and exposure to technology and contain different rural and urban populations. in each country, two sites were selected: one rural and one urban. the rural site in canada was the town of mcbride (bc), and the urban site selected was the city of regina (sk). the rural sites in the uk included the village of cwmtwrch and the village of ystalyfera in wales, and the urban site was the town of milton keynes (buckinghamshire) in england. participants were recruited through the use of posters and mailing list scripts tailored to each site distributed to local organizations including the older people's forum, seniors' centers, public libraries, seniors' community newsletters, and local public radio. participants were also recruited through word of mouth in the community. participants each voluntarily contacted the lead investigator for the research site closest to them to request to participate in the study. upon contact, the participants were sent an email containing a link to the online survey, information on the study and a request for written consent to participate, and an invitation to set a date to join a focus group interview. all participants completed the online survey prior to participation in a focus group. the survey was an iteration of an earlier survey [14, 59] , which covered eight domains: (1) technology use, (2) internet ownership and use, (3) social networking, (4) digital device ownership, (5) purchasing patterns, (6) quantified self-and life-logging, (7) information sharing and privacy issues, and (8) demographics. bivariate analyses of the survey data were conducted using spss version 24. an inductive approach was taken to generate new knowledge from the qualitative data. a descriptive approach is beneficial for an initial study, as such an approach allows the researchers to richly describe the phenomenon being studied. focus group discussions, led by the lead researcher from each site, lasting between 40 and 60 minutes, were digitally audio-recorded and then transcribed verbatim in microsoft word by a uk-based transcription company. all the lead researchers were experienced in conducting qualitative research analyses and in leading focus groups. a semi-structured interview guide containing questions and probes was used to facilitate discussion (supplementary materials). the questions examined several areas including the ownership of technology, the purpose for using technology, internet social media use, life-logging, privacy issues and the sharing of information (e.g., what type of information and rationale for sharing), and willingness to embrace new technology (supplementary materials). content and inductive analyses [60] were conducted across all the transcripts. given the exploratory nature of this analysis, the transcriptions were read closely for familiarization with the data, coded, and analyzed thematically. the data were classified into categories as a way of describing key themes [61] . in addition, areas of concordance and discordance were examined through the analysis. specifically, open coding, with the creation of categories and abstraction, was undertaken. coding was first conducted independently by a research assistant, trained in qualitative research methodologies and experienced in conducting analysis, and by a co-investigator, both of whom then came together to come to a consensus on the coding. discrepancies were addressed by recoding areas of discordance, and then, the transcripts were reanalyzed by the research assistant and reviewed by a co-investigator of the study to promote accuracy and trustworthiness [62] . ethics approval was granted by all four institutions. thirty-seven participants both completed an online questionnaire and attended a focus group discussion. this included 20 rural participants (mcbride, canada, n = 10, cwmtwrch and ystalyfera, uk, n = 10) and 17 urban participants (regina, canada, n = 6 and milton keynes, uk, n = 11) from 2015 to 2016. most participants were female (67.6%), retired/not employed (86.5%), and in their late 70s (mean age, 77.4 years). five themes were identified relating to intergenerational relationships. three themes focused on the benefits of intergenerational relationships to support use of technology including 1) motivation for older adults to use technology, 2) use of technology as a facilitator of intergenerational connection and 3) technology use for safety reasons. additionally, two themes focused on the impediments of intergenerational relationships to use of technology including 1) using technology to appease younger family members; and 2) learning how to use technology in later life. all participants used technology, the majority of whom did so on a regular basis (table 1) . nearly all participants used a computer (97.3%) and owned a computer (89.2%). most participants had used a computer for at least 10 years (75.7%) and used a computer more than once per day (62.2%). all participants used a digital device, typically a mobile/cell phone (70.3%), and to share information (82.7%). nearly all participants identified having internet at home (94.3%) and most had used the internet for more than 10 years (75.8%). participants used technology for a variety of tasks including e-mail, word processing, playing games, making telephone calls, online shopping, online banking, sharing information, social networking, searching/checking information, instant messaging, reading, uploading content, and lifelogging. over half reported using social media (54.1%, n = 20) with more canadian participants' self-reporting use of social media when compared to participants from the uk (62.5% vs. 47.6%) ( table 2 ). a primary motivation for participants to use technology was as a "digital gathering place" to communicate with family, especially adult children and grandchildren, and friends. participants communicated through technology in a variety of ways including skype, facetime, e-mail, social networking sites (e.g., facebook), and texting through cellular networks or whatsapp. interestingly, it was common that participants who used technology were taught how to do so by younger family members. the value of digital communication was enhanced when participants' children and/or grandchildren lived far away. "skype is brilliant. i've got a daughter in spain, i've got a granddaughter in spain, i've got a son in the west indies and a daughter in london, and skype is one of the most brilliant things that's happened because you can see, you can talk." [mk6, male]. "i've used skype because my daughter lives in south africa, but it's an atrocious service because south african broadband is atrocious. we now use apple facetime and that is far superior." . it is also useful to note that participants adjusted the platforms they used not only due to personal preferences but also in response to the variance in the infrastructure and broadband support across the locations. older adults reported using technology to connect with friends and family members, and to share information, also likely with family members. participants often used computers for email (85.3%) and social networking (38.2%), most often in their own home (97.1%) and occasionally at an adult child's home (17.1%). social networking sites were used to stay connected with children and/or grandchildren and friends, to share photos and information with friends and/or family, and to keep up to date with news. the internet was used for sending/receiving e-mails, social media, making phone calls through skype/viber, and instant messaging. older adults both created and sent content (e.g., photos and emails), as well as receiving content. it was both older adults and their family members/friends who took turns initiating contact. most participants identified that they used technology to write or speak with other family members; there were a few instances where participants reported using technology to partake in and share the hobbies of younger family members. older adults were keen to try new things with their grandchildren such as interactive videogames and immersed themselves in the flow of the games. one participant noted, "[ . . . ] jumping up and down to the things that they've got on the screen when you play tennis or jump up and down and dance, or whatever you're chasing, something. yes. video games, i suppose. childish ones." [mcb2, female]. another participant used her daughter and granddaughter's ipad to take pictures of the community garden. participants suggested that technology is not only used to connect and communicate with younger family members but also to learn about and actively participate in activities with younger generations. of the participants using technology to stay in contact with family, some also acknowledged having started using a digital device for safety reasons at the suggestion of another family member, commonly an adult child. most participants reported owning a mobile device or cell phone, many of whom owned these devices for "safety" [regina2, female] and "emergencies only" [mk5, female]. one participant living in rural british columbia described how they started using a digital device specifically for driving purposes as well as feeling the need to maintain a sense of peace with their adult children. "i got the cell phone because my kids kept thinking something was going to happen to me. i said, "well you know if i have a breakdown on the highway, we managed for 70 years for god's sake by just stopping someone and they'd help you. but now, "oh my god they could murder you." so, this was supposed to be a safety element to keep peace in the family." [mcb1, female]. this participant further described displeasure with the cell phone because it cost them money each month and they never used the device. several participants identified that they got digital devices at the suggestion of an adult child after having suffered a health scare. for example, when asked why they got a cell phone, one participant replied, "oh, well it was the bright idea of my son. i had a mini stroke . . . ever since, but they're [kids] always frightened . . . of a recurrence. so, my son gave me a cell phone, his old one, which i used right away, or more or less. i think, they decided that i should have one, because i did get a few dizzy spells. so, now i just use it" [mcb2, female]. even though it was often a younger family member, such as an adult child, who suggested the participant carry a digital device for safety-related reasons, most participants had positive perceptions of using technology for such reasons. for example, one participant spoke positively of how they wore a certain piece of technology that they can press in an emergency situation to notify a family member or emergency service that help is needed. while it seems that most participants use technology to keep in touch with younger family members, the reasons for this contact vary, from safety and emergency situations to routine check-ins with children and grandchildren. in some instances, participants seemed to use technology to make a younger relative happy even if they did not seem to need the technology. for example, "i don't even have an iphone or ipad so i'm really out of date . . . i will get more modernized so that my children will be happy" [regina2, female]. another participant stated, "i've got a tablet that i was to take away with me because my grandchildren said it would be useful to have and i wouldn't be using theirs whenever i'm away on holiday with them. i don't get on terribly well with a tablet . . . " [mk2, female]. common responses for why participants owned technology included similar motivations, stemming from the children: " . . . the kids decided we should have one [computer]" [mcb4, male] and that their grandchildren were putting pressure on them to keep up with the latest technology. furthermore, one participant explained that they were learning technology because the " . . . grandchildren push me and they go, 'oh nana, you're so far behind, you should be up to date and you should be doing this and doing that.' so, they want me to be up to date with all the latest technology and i'm not." [regina3, female]. in certain cases, younger family members purchased technology for older family members as gifts. one participant reflected on a life logging device they owned, explaining, "my daughter bought it for my birthday . . . " [wales1, female] after her husband began experiencing a health decline. these examples illustrate, across the different study sites, how the respective participants felt about technology and how digital devices had been implemented into their lives without consideration of their respective feelings, needs, and choice. many participants used computers as integral components of their jobs decades ago and were among the early adopters of computing technologies. one participant who was familiar with computers explained that they used to do it at milton keynes college. similarly, a participant from mcbride learned the fundamentals of using a computer for their accounting position, explaining that they learned about spreadsheets. however, with the rapid pace of technology development, the technological skills participants had employed prior to retirement became quickly outdated. participants described that the challenges in keeping up with the rapid pace of changes in the technology itself were compounded by their frustrations in keeping up to date on the expanded language used to describe the technologies. participants described the complexity in language and terminology used in technology tutorial classes and instruction manuals as too complicated and inhibiting their ability to adopt new technologies. one participant identified that instructors at computer classes "go way too fast for me. i can't keep up; there is too much new information . . . the language like computer and technological language is totally different from what we were raised with" [mcb2, male]. another participant identified similar grievances about learning to use technology, such as the fact that they "can't understand technology words" [mcb1, female] in instruction manuals and that when speaking with information technology (it) specialists, the it specialist would explain too quickly. although participants noted how they were confused about how to use technology, they still managed to do so, most commonly with assistance from younger family members. participants were frequently introduced to digital devices and to social networking sites by a relative or adult child. participants alluded to younger family members playing a key role in the learning process, saying things such as "my son set it [skype] up . . . " [mk2, female] and "oh, my daughter is the one that does all the computerizing. she helps . . . " [mcb2, female]. they emphasized that they were not technophobic or averse to use of the technology itself but felt outpaced by the speed of change of technology. for many, they were unable to overcome the language barriers created to adapt and adjust to changes in technology on their own or with those of a similar age. instead, they would connect with younger generations for help. where confusion over technology existed, younger family members took on a teaching role, especially for newer technologies such as digital devices and social networking programs. "i ask my grandchildren. 'okay, how do i do this?' they say, 'don't you know?' but they will help me eventually" [regina3, female]. younger generations were able to bridge the technology gap and communicate complex language in lay language that was non-threatening. "anything i want to know, i have to phone up my sons or my grandchildren because they're a lot more knowledgeable than i am . . . " [mk1, female]. even after being introduced to technology and learning how to use it, participants continued to contact their adult children and other relatives for assistance when faced with difficulties. for instance, one participant stated that "my son is an it expert. if i have any problems, 'can i speak to the it man please.' he knows it's me. he sorts my problems" [mk3, female]. some participants seemed to solely rely on younger family members for information when necessary. for instance, one participant concluded, "if i need to know something, i will get my daughter to look it up on her, whatever thing she packs in her pocket" [mcb4, male]. for many older adults, intergenerational relationships are leveraged to support the understanding and use of technology. the challenges in the adoption of and adaptation to the rapid developments in digital technologies facilitate opportunities and meaningful purposes for participants to connect and communicate with younger generations. the leveraging of technologies, including social media and virtual communication platforms, supported older adults in maintaining and enhancing social connections, especially with adult children and grandchildren who lived in different cities and countries. these findings support the idea that the use of digital technologies can enhance social connectedness across generations; as taipale noted, "[ . . . ] distributed families can today nevertheless remain connected and feel a sense of togetherness, even when their members are not physically close to one another" [28] . the benefits of intergenerational relationships for technology, including motivation for older adults' use of technology and the use of technology as a facilitator of intergenerational connections, underlie each domain of the who checklist of essential features of age-friendly cities [63] . furthermore, this reinforces the need for a revised smart age-friendly ecosystem framework as coined and posited by marston et al. [10] , who proposed an extension, noting that these features also apply to the rural, and non-urban, context. the desire to mitigate the digital divide fuels older adults' motivation to invest time in building and fostering intergenerational digital connections. previous research similarly suggests that computers are commonly used by older adults as a method of communication with younger generations, serving as a gateway to the world of younger family members and a means to strengthen relationships [64] . studies show that individuals will often play games, not because of enjoyment of the game itself, but because of the social interaction with others with whom they are playing [65] . therefore, when creating an age-friendly environment or helping older persons to age in place, it is worthwhile to challenge those designing built environments to consciously address how they may seize opportunities to effectively and efficiently leverage icts to facilitate intergenerational engagement. older adults leveraged technology to connect, communicate, and actively participate in the interests and hobbies of their adult children and grandchildren in online formats, including digital gaming and photography. participants encouraged and enjoyed interacting with younger family members to learn about different technologies (e.g., digital games) as a way of immersing themselves in the culture of younger generations. as previous research illustrates, participants in this study were using digital games as a "computational meeting place" that supported meaningful social interactions and shared motivation for group gaming [66] . further evidence shows that gaming technologies foster intergenerational group interactions of up to four generations, including adult children and extended families [67] . our study revealed findings similar to those noted above but for multiple digital technologies, which suggests a more universal and generalizable use of technologies among older adults to increase intergenerational family social interactions as a "digital gathering place". health limitations, the costs of transportation, and social isolation can create barriers for travel, all of which might explain why communication technologies such as skype were often used to connect with family members. these technologies can come close to replicating the face-to-face experience of conversing with another person and are an effective communication method to use when travel is not an option. the extended value of the support of intergenerational connection may be further amplified given the context of covid-19 and in the post-covid-19 context. language and terminology often impede the ability of older adults to learn how to use technology. this disconnect and incomplete understanding of technological language could explain why few respondents identified using social media/networking sites but went on to further indicate they do in fact use this form of technology. this discrepancy in responses may stem from a lack of clarity in the question about what social networking entails for the respective participants, or this may reflect a lack of recognition by older adults that they did in fact use social media/networking platforms. despite these complications, participants were able to use technology and associated icts by learning to do so with their adult children and grandchildren, who were able to translate the jargon and technical terms used in information technology courses into a language that older adults could understand within the context of intergenerational relations. this is consistent with the findings from previous studies showing that adult children often initiate the technology use process for older adults and that extended family members (such as grandchildren) are important educators for older adults as they learn to use technology [64] [65] [66] [67] [68] [69] . intergenerational informal education between those with existing relationships may be more effective for knowledge/information exchange. when considering why adult children and grandchildren were common educators, there are a few ways to explain this finding. first, older adults might feel more comfortable learning from family members due to feelings of trust. second, as it was often adult children and other relatives who introduced participants to technology, it makes sense that they would be the ones providing the lessons and education. third, participants may have been learning from younger generations because they may have a greater knowledge of technology, having grown up in the information age. fourth, older adults might choose to learn from younger family members as they use less confusing terminology (compared to user manuals or classes) and they are comfortable enough to ask questions. many older adults in the present study used technology comfortably and were among the early adopters of computers and technology. the role younger generations play in guiding and motivating older adults to use technology may contribute to family cohesion and strengthen relationships. this supports the notion of the "change in family roles" put forward by taipale [28] , who highlighted the variance of perception between italian and slovenian contexts. nearly all participants reported using a computer at their own home, but other locations such as an adult child's home were also identified. studies have shown that, among older adults who use computers, a majority do so in the comfort of their own home, although computers are also used in public locations such as at work, in a library, or at a friend's/family member's home [14, 37, 53, 70] . computers might be used at an adult child's home because this is where the learning and introduction to technology take place. however, this pattern of usage could also be indicative of locational convenience, access to computers, privacy issues, what the computer is being used for, or another combination of variables. these preliminary findings point to the importance of investigating further how these intergenerational factors influence the location of technology use. even though participants highlighted the many benefits and uses of technology, some participants remarked on the drawbacks and risks of living in the digital age. the finding that older adults often chose to use computers for leisure to share information and communicate, whereas cell phones were often used to appease worried children, suggests both positive and negative associations of technology. for instance, surveillance and privacy issues, along with digital crime, are risks of using certain technologies [71] . despite the existence of privacy legislation, there exist privacy threats with the use of technology, such as the tracking of personal information, profiling, and privacy-violating interactions [72] . despite voiced concern over privacy issues, participants continued to use technologies because of the benefits, such as bridging geographical distances to communicate with younger family members. as such, it seems the rewards outweigh the risk for older adults to use technology. nonetheless, the acknowledgment of such risks by participants draws attention to the importance of providing clear education communicated in lay language on how to safely use technology. this research specifically addressed intergenerational elements of technology use among individuals in both rural and urban areas in two countries. research often overlooks social elements of technology use, viewing technology engagement as a solo activity. a strength of this study is the combination of an in-depth online survey and focus groups, which allowed for a deeper understanding of the topics being studied. upon further validation, the survey could be used in future studies as a standard measure of technology use, social media habits and behaviour, information sharing, and privacy issues. given the exploratory nature of the study, a small sample was acceptable as the aim was for each site to recruit 10 participants. although our sample sizes enabled us to reach saturation of information, a larger sample is needed to confirm our findings. differences in the recruitment methods across sites may have contributed to the difficulties of achieving the targeted number of participants. future studies should recruit participants who use and who do not use technology to compare and contrast their behaviours and identify further barriers to and enablers of technology use in later life. further investigations may extend this work to examine the intersection of technology and intergenerational relationships among older adults who are aging without family to expand the understanding of the roles that peers, friends, or even siblings play in comparison to that of adult children [73, 74] . at a time when technology development and population aging research are prevalent, it is vital to capitalize on opportunities to learn about how technology can be used and deployed to increase social connectedness, improve the quality of life of older adults, and support aging in place. with rapid technological developments occurring, there are great opportunities to expand the understanding of gerontechnology and human-computer interaction from a multi-disciplinary standpoint. technology has the potential to play an integral role in ensuring all attributes complement each other and keep knowledge up to date. many participants used technology to maintain social connectedness with younger family members who were geographically dispersed. the findings from this study provide insight into the strengths and opportunities that technologies provide to older adults. understanding how intergenerational relationships impact technology use in later life can inform further research and technological and social practices. tech adoption climbs among older adults. pew research center media use in the european union older adults and technology use world 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processes of learning to use computers internet use among midlife and older adults: an aarp bulletin poll digital crime and digital terrorism privacy in the internet of things: threats and challenges the lived experience of older involuntary childless men ageing without children, gender and social justice we would like to thank all participants who agreed to take part in this study across the different study sites. the authors declare no conflict of interest. key: cord-158160-dka81tqx authors: vincalek, jakub; walton, sean; evans, ben title: it's the journey not the destination: building genetic algorithms practitioners can trust date: 2020-10-13 journal: nan doi: nan sha: doc_id: 158160 cord_uid: dka81tqx genetic algorithms have been developed for decades by researchers in academia and perform well in engineering applications, yet their uptake in industry remains limited. in order to understand why this is the case, the opinions of users of engineering design tools were gathered. the results from a survey showing the attitudes of engineers and students with design experience with respect to optimisation algorithms are presented. a survey was designed to answer two research questions: to what extent is there a pre-existing sentiment (negative or positive) among students, engineers, and managers towards genetic algorithm-based design? and what are the requirements of practitioners with regards to design optimisation and the design optimisation process? a total of 23 participants (n = 23) took part in the 3-part mixed methods survey. thematic analysis was conducted on the open-ended questions. a common thread throughout participants responses is that there is a question of trust towards genetic algorithms within industry. perhaps surprising is that the key to gaining this trust is not producing good results, but creating algorithms which explain the process they take in reaching a result. participants have expressed a desire to continue to remain in the design loop. this is at odds with the motivation of a portion of the genetic algorithms community of removing humans from the loop. it is clear we need to take a different approach to increase industrial uptake. based on this, the following recommendations have been made to increase their use in industry: an increase of transparency and explainability of genetic algorithms, an increased focus on user experience, better communication between developers and engineers, and visualising algorithm behaviour. t his paper aims to provide insights for developers and researchers of genetic algorithms and engineering design tools. these insights include the attitudes that engineers and students have towards genetic algorithms. the current barriers they face in the design process were explored. a total of 23 participants were recruited for a mixed methods survey. their opinions were analysed thematically as a means of establishing their preferences with respect to engineering design tools and genetic algorithms. this paper provides a number of recommendations for developers and researchers. the contribution of this paper to the domain of evolutionary computing is establishing best practices with respect to the development of genetic algorithms in the context of design engineering. genetic algorithms (gas) are nature-inspired algorithms. they use the process of natural selection through selection, crossover and mutation to search for an optimal solution to a problem. the solutions are driven to optima by a fitness function which dictates which traits are selected for the next generation. some common examples of gas are particle swarm optimisation [1] , artificial bee colony [2] , ant colony optimisation [3] , firefly algorithm [4] and cuckoo search algorithm [5] . examples of natural phenomenon gas are colliding bodies optimisation [6] and gravitational search algorithm [7] . 1) applications: gas have proved to be a powerful tool for optimisation [8] [10] . their application ranges from very simple mathematical formulae to complex systems with many interdependencies. the design of a simple cantilever beam [11] and elaborate aerodynamic design [12] showcase the range of applications. to measure the effectiveness of an algorithm, they are often tested against standard benchmark functions such as the ackley function [13] and constrained engineering problems like a welded beam or a pressurised vessel [14] . multi-objective optimisation (mo) problems are particularly well suited to gas. many engineering problems can be classified as mo; these designs involve many different trade-offs. it is often challenging for human designers to determine an optimal solution without the aid of a computerbased system. one example of an mo problem where a ga was used successfully is presented by tawhid & savsani [15] who evaluated their artificial algae algorithm on 20 different benchmark problems to show its suitability for engineering design optimisation problems. an industrial application of mo engineering can be found in aerospace, specifically the design of geostationary satellites. customer demands for higher bandwidth capabilities and longer lifespans [16] are at odds with the many constraints in place. these constraints include • higher power requirements; • thermal considerations, including hot and cold zones; • the ability to fit in a rocket fairing; and • the ability to withstand vibrations during launch. each of these variables need to be considered throughout the design lifecycle of the satellite. to illustrate the usefulness of gas in this context, berrezzoug et al. [17] proposed a method which applies a gravitational search algorithm to the design of a satellite by considering the many design variables. the approach proved useful for determining optimal trade-offs between the variables. optimisation problems do not need to be strictly product design based either. the layout of a construction site is another kind of mo problem. offices, equipment and warehouses are among the factors which influence the layout. the objective for any layout is to maximise the time spent on value adding activities while decreasing wasteful activities like transportation or waiting. in addition to this, the safety of the construction workers and engineers cannot be compromised. one attempt at this was done by kaveh et al. [18] who demonstrate the application of a colliding bodies optimisation algorithm to a construction site layout. their solution demonstrates that a problem with n! combinations can be effectively solved with a ga. the optimisation problems presented in this section are bounded by the constraints put on them by external factors, such as launch conditions for a satellite. in the following section, the constraints that designers face, such as resources and time, will be explored. these factors present barriers for the designers when attempting to optimise their designs. 2) the relationship between humans and algorithms: rather than acting as autonomous agents, gas can be integrated in the design process to enhance the capabilities of human designers. in recent years, a growing trend of combining the expertise of designers with algorithms has been taking place. for example, ant colony optimisation was applied to the design process of the layout of train tracks [19] . the layout can be optimised to reduce the energy consumption of the trains as they travel the tracks. furthermore, flurl et al. [19] propose a method to allow design engineers to see the effects of their changes on energy consumption in realtime. this method takes advantage of the algorithm's ability to find an optimal solution while allowing the designer to stay in control of the track layout. the push for user-centric design is evident in engineering as well as other disciplines such as architecture. in a 2017 survey of 165 architects, 91% of respondents would like to see an inclusion of a "human-in-the-loop" approach with regard to the software and technologies they use [20] . furthermore, 93% of respondents wanted to be able to understand the underlying principles of the algorithm while just over half (54%) would like full control over the process. in an attempt to bring this to fruition, berseth et al. [21] propose an interactive computer-aided design (cad) optimisation program. it engages with architects by analysing their designs and optimising for a number of variables such as "open space in passages, aesthetic relationships, or building codes." this is akin to the mo problems encountered in aerospace engineering applications such as satellites, but also in the development of rockets. in fact, a user-centric approach was adopted by engineers at nasa [22] and allowed engineers to evaluate the interdependencies that different systems had to each other with respect to the mission objective. other approaches attempt to rely too heavily on algorithms alone and exclude human intervention. this approach leads to systems either whose complexity is increased or explainability is decreased. explainability is the ability for a developer or user to understand a model's behaviour [23] . two examples of approaches which rely too heavily on algorithms have been shown when trying to solve mo problems. the first is a symbiotic organisms search algorithm which was developed by ustun et al. [24] . it is a very recent algorithm that may perform better than other standard ga for certain mo problems, but falls victim to the no free lunch theory [25] . the no free lunch theory states that for all problems in which a supposed algorithm x outperforms algorithm y, there are an equal amount of problems in which algorithm y outperforms algorithm x. in short, there does not exist an algorithm that will be the best choice in all scenarios. the development and tuning of gas is itself an optimisation problem and gas are developed on a case-by-case basis with their applicability to different situations being very limited. the second example of an over-reliance on algorithms has to do with eliminating the consideration for external factors on the optimisation process. fleck et al. [26] discuss a method to reduce an mo problem down to a single value. this is a problem for any real-world engineering application. take for example the previously mentioned satellite problem. there are many design variables to consider and their dependencies must be investigated in depth. the lack of explainability would be difficult to justify in satellite development. a need for explainability was also noted by burnell et al. [22] when incorporating their approach at nasa. by combining human expertise with algorithms, designs that are both optimal and adhere to all design constraints can be produced. this is demonstrated by guo et al. [27] for bolt supporting networks. users could select from a range of solutions which were fed back to the algorithm to develop a solution that was strong, cost-effective and manufacturable. oulasvirta [28] considered user-centric design when applied to user interface (ui). one of the key points raised with the approach was that the "designer can steer and redefine the tasks intermittently as results stream in." thus, an optimum between designer and computer also exists; a region in which the algorithm is able to perform the necessary calculations while the human designer can focus on producing a result in line with their vision. the real-time approach is adopted by umetani & bickel [29] and is applied to automobile aerodynamics. the changes made by users and the effects those have on the drag characteristics of the vehicle can immediately be fed back to the designer. incorporating humans in the optimisation process indirectly involves designers from outside of the design process. this is because engineers do not work in isolation, but rather as a team. adjoul et al. [30] observed that optimisations in the production phase required experts from both production and design to work together to create an optimal product. the entire life cycle of a product must be considered when dealing with optimisations. an instance of this is probed by kang et al. [31] while considering the trade-offs faced by customers when purchasing a new car. their techniques "could readily lead to crowdsourced, real-time, manufacturer-feasible design optimization [sic]," which includes customers, designers and engineers. the integration of designers in the design loop has been shown to be possible. the results, however, have been focused on the quantitative aspect of the application. an in-depth thematic analysis of the opinions of practitioners has not been evaluated in all the previously mentioned papers, which this paper contributes to the field. academic literature has shown that the use of gas can add value in industry. however, the best way to do so remains unclear. gaining a familiarity with the way designers work can be used to develop a better understanding of why the uptake remains low. the following research questions were posed: 1) to what extent is there a pre-existing sentiment (negative or positive) among practitioners towards genetic algorithm-based design? 2) what are the requirements of students, engineers and managers with regards to design optimisation and the design optimisation process? the survey consisted of 3 parts. part 1 was used to gather non-identifying traits about the respondent such as their experience in the field and their roles. part 2 gauged the respondents prior knowledge of the domain as well as their preferred characteristics for design tools. part 3 of the survey had 6 optional, open-ended questions aimed at determining the current state of a design process and the respondents attitudes towards algorithmic design aids. there was no time limit for responses, however, 20 minutes was suggested as an estimate of time for completion. the analysis of the results have been broken down into three parts to reflect the structure of the survey. thematic analysis has been used for part 3, while parts 1 and 2 can be analysed quantitatively. a total of 23 participants (n = 23) answered the survey over the course of 9 days. all participants answered all questions in parts 1 and 2. some respondents chose not to answer some or all questions in part 3. the total number of responses per question in that part are given along with the result. the survey was created electronically using google forms. a link to a survey was posted on various social media sites (twitter, linkedin, facebook, reddit) to gather responses; emails were also sent directly to those with known prior domain experience. ethics approval for this study was granted by the swansea university college of science ethics committee (su-ethics-student-110620/2921). participants were asked to categorise themselves based on their current roles. the sum of the responses exceeds 23 as some participants may feel that more than one category applies to them. more than half (n = 13; 57%) of the respondents considered themselves as engineers, with roughly a third (n = 8; 34%) specifically selecting "design engineer." some participants (n = 5; 22%) selected more than one descriptor. participants were asked to state their highest level of education. all participants but one (n = 22; 96%) hold either an undergraduate or postgraduate degree. slightly under half (n = 10; 43%) of participants hold a postgraduate degree. the specific degree was not probed. in addition to their education, respondents were asked to state their length of experience in the field of engineering design as well as their self-declared proficiency. the proficiency was declared on a 6-point likert scale (from "not proficient whatsoever" to "extremely proficient"). of all participants, just under a third (n = 7; 30%) indicated they had more than 10 years of experience in this field. moreover, most (n = 19; 83%) participants indicated they are at least "proficient" in engineering design. over half (n = 10; 43%) of those 19 would say that they are very proficient while one (n = 1; 4%) participant indicated extreme proficiency in engineering design. respondents were asked how they had heard about the survey. this questions served as a means to determine which platform attracted the most participants. the data is useful for future surveys, however, bears no effect on the analysis of the results of this survey. five (n = 5; 22%) of the participants recruited via email have an existing professional relationship with one the authors. an additional question to determine how familiar respondents were with the field prior to answering was posed. to do this, some common and other, more niche terms were selected by the authors to gauge that prior knowledge. the question listed terminology associated with evolutionary algorithms. the most frequent terms that participants had previously encountered were "genetic algorithm" and "evolutionary programming." both had been selected 15 times. the least frequent terms were "selective search" and "adjoint state method." these terms were selected 4 times and 3 times, respectively. one (n = 1; 4%) participant did not select any terms and none of the participants selected all the terms. the technique used to evaluate the results of the open-ended questions in this survey is thematic analysis. the process behind the evaluation is based on the work of braun & clarke [32] . the steps outlined have become standard practice to conduct similar research in areas such as psychology, sports science, and engineering [33] [35] . a brief overview of each step is given. 1) initially, a general familiarisation of the data is conducted to get a general overview of the contents. a rough idea of codes is written down and used as a starting point for the next step. 2) once the data has been familiarised, the process of coding begins, which is the labelling the data that appears interesting. this can be one or two words within the data or a short segment that conveys a narrow idea. 3) once the data has been coded, the codes themselves are grouped together in general themes. the relationship between themes is also explored at this stage. 4) themes are reviewed at this point. some themes may need to be split, combined or otherwise adjusted. importantly, a pattern must be evident within the theme among the codes. a complete review of the data is also done at this point to bridge any gaps that may have been missed initially. 5) themes are concretely defined at this step. again, themes may be restructured to ensure that each theme has one central idea. 6) lastly, the analysis of the data is written up. the analysis is broken into individual themes using codes and data to support the arguments. three metrics to ensure the highest quality of analysis are outlined by nowell et al. [36] and consist of credibility, transferability and dependability. through the realisation of the three metrics, then a fourth metric is fulfilled according to guba & lincoln [37] : conformability. to ensure that these metrics are being met, nowell et al. [36] suggest an audit trail is set up so that any researcher could follow the logic. also suggested is that researchers remain critical of their own findings. electronic records of the analysis were shared among the authors. acknowledging internal bias is key to maintaining credibility. in an update on their 2006 paper, braun & clarke [38] describe researcher bias as an inherent component to thematic analysis and point out that it is the researchers who generate the themes rather than the data itself. knowledge of one's own bias is 1 of 9 recommendations provided by castleberry & nolen [39] . as per the recommendation, bias is discussed later. this part contained five questions which assessed the respondents' preferences with regards to engineering design tools. the criteria are user interface, versatility, robustness, frequency of use in industry, and supporting documentation. the questions were evaluated on a 3-point likert scale; the participants had the option to choose from "no importance," "some importance" and "high importance." an additional option of "no opinion" was provided for respondents. as seen in figure 1 , the two most important criteria according to participants was user interface (ui) and robustness (ro). both of these criteria had a majority (ui: n = 15; 65%, ro: n = 14; 61%) of respondents mark them as highly important. with respect to ui, the participants declared that it is at least somewhat important when considering design tools. from the answers given by participants, the criteria can be ranked: user interface, robustness, supporting documentation, versatility, and frequency of use in industry. this ranking however does not negate the need for any of the criteria as all had been ranked as somewhat important by the majority of participants. from the thematic analysis, 3 themes were generated and were given broad names to serve as an overarching link: human, product, and technology. the associated codes are visualised in figure 2 . coding could be done on 12 of the answers. the remaining 4 answers contained insufficient detail to accurately assess the meaning and intention of the respondent, or did not answer the question in a coherent manner. the incoherency of answers in this question and following questions had to do with a lack of any sentence structure. the first open-ended question was geared towards answering the second research question. when discussing the current state of their design processes, participants approached the question from different angles. using the generated themes as a starting point, 4 included a human element, 7 from a product perspective and 3 made reference to technology. 2 answers had two themes present. many of the answers that fell under the product theme were heavily focused on the design itself. this included talking about the requirements of the design, refinement and optimisation. participants were also asked to included proportions of their time spent at each stage of the design process. 3 participants gave a breakdown while 1 participant only noted the longest stage of the process. for these 4 participants, iteration/optimisation/redesign takes a significant portion of their time. some participants also included other considerations into the design process such as designer experience, designer preferences and customer/supplier relationships. with regards to customer requirements, participants said that those requirements are used as a starting point for high-level, initial designs. combined with answers that gave design process time breakdowns, this stage takes up about 25% to 40% of the process. one participant, a manager, also noted that finding an optimal solution is "highly unlikely" although admitted that solutions could be found that are quite close to the optimum. this is in line with another participant, an engineer, who mentioned multidisciplinary optimisation (mdo) which invariably results in compromises. these in turn lead to lessthan-optimal designs. of course, this is acceptable as long as the design requirements are met. 2) question 2: what barriers do you have to overcome during the design process?: this questions was answered by 16 participants. again, this question was related to the second research question. most (n = 11; 69%) of the participants' answers in the second question fell under the product theme. 5 participants explicitly stated that cost was a barrier to their design process. other resources, such as time and processing power were also mentioned. previously, it was noted that some participants use the customer requirements as a starting point for their initial design. for one participant, this was incidentally their biggest obstacle. this lends itself to another problem, where the customer does not have clear requirements. both optimisation algorithms and engineers rely on a clearly defined objective around which to construct their solutions. one engineer relayed that selecting weights for a fitness function was a barrier to their design process. this is indicative of an over-reliance on the expertise of the engineer and a lack of technology meeting its potential. spending extra time determining weights takes time away from engineers adding value in their area of expertise. both a student and an engineer mentioned competing design requirements as a barrier. incorporating conflicting requirements can be challenging, especially when, as mentioned earlier, requirements can be unclear or ill-defined. another two participants, a student and a design engineer, mentioned their own knowledge as a limitation to the design process. for the student, being confident enough to be able to get their design from a mental model to a cad model was a hurdle. for the engineer, the "learning curve of toolsets" was one of the obstacles. these two answers offer insight into which aspects of the design process can be improved with (better) technology and which are subject purely to engineers. two instances of trust were brought up: one from an engineer and another from a manager. the first had to do with trust in the technology itself, specifically design simulations. the results from simulations must be accurate so that engineers can make informed decisions about the design and ultimately the final product. the second instance of trust was related to the participant's peers. getting buy-in from new colleagues was mentioned as a barrier. for this participant, trust was instilled as a result of the outcome of the project. this is one manner in which gas can gain an engineer's trust, although it would still require a high level of trust from key early adopters. 3) question 3: what comes to mind when you think of evolutionary algorithms?: this question was answered by 16 participants. the intention of this question was to gauge whether respondents have any prejudices or preferences towards algorithms as a part of the design process. this question was in line with the first research question. the answers in this question came under two themes: technology and human. the count for each was 10 and 2 respectively. 4 answers were not coded: of these, 3 pertained to biology and did not fall in among the themes while 1 answer was too short to accurately determine the respondents intention. the answers which related to biology were not put into a theme because the creation of an additional theme did not seem appropriate for 3 out of 101 total answers. two managers expressed a negative sentiment towards the term used in the question: evolutionary algorithm. the first participant stated that it is "over-rated in practice" and preferred more rudimentary optimisation methods; pattern search was given as an example. the second participant questioned the ability for evolutionary algorithms to add value. both participants point to a hurdle that new technology faces: convincing stakeholders that learning a new technology or system is worth the time investment. this sentiment was echoed by an engineer when responding to the last open-ended question. by noting the shortcomings of the current state of gas, a clear pathway to wider adoption can be determined by addressing their concerns. other participants related the evolutionary algorithm to an automated processes or global optimisation. three different participants mentioned artificial intelligence (ai) and machine learning (ml). seven participants used a variation of selective process, biology and survival of the fittest in their answers. these answers indicate that developers of these algorithms should include a succinct explanation to let engineers have a better understanding of their mechanisms. 4) question 4: do you trust the designs produced by automated optimisation algorithms? explain your answer.: this question was answered by 18 participants. as with the previous question, it was aimed at answering the first research question. participants could very easily be categorised in this question. 13 participants expressed varying sentiment of doubt regarding the result produced by an algorithm. as an example, participants noted that they prefer to check the results of an algorithm by hand. one design engineer extended this by stating that the results would have to be validated by a real world test. this is an example of maintaining the human element in the design process. keeping the human element in the process is threaded in nearly every answer. another design engineer noted that "there are some processes in optimisation that require experience and intuition," which is a direct call to designer expertise. likewise, one student incorporated the entire lifecycle of the product in their answer; cost, manufacturing and feasibility for human use. a similar sentiment was shared by another student in that some results may be outside of the constraints of the design space. three participants stated an outright trust in results generated by algorithms. one of these respondents, an engineer, states that the results are "usually overchecked." this is contrary to another engineer's answer, who stated "a 'blind' trust [in automated optimisation algorithms] is a bad approach." both sides point to the need for a proper explanation of the potential applications of these algorithms as well as the limitations. this question also revealed some feelings that designers have towards optimisation algorithms. designers will not trust the final design unless they can understand the process the algorithm took to yield that result. 5) question 5: do you think a computer-based algorithm could help your design process? explain your answer.: this question was answered by 18 participants, although one answer can be discarded as the respondent simply stated that the question was not applicable. this question was related to both research questions. two thirds (n = 12; 67%) of participants expressed a positive sentiment towards working with algorithms in their design process. much like the previous question, the degree to which participants wanted to incorporate this technology varied. one manager stated that they have already incorporated optimisations into their process. a student declared that they would use it only for the initial design stage. the development of this technology should be able to cater to those who want to use it for one or all parts of during their design processes. one design engineer gave requirements in anticipation of such technology being incorporated in their process. the most important requirements for this participant was a properly designed ui and a link to other engineering tools. a seamless experience allows engineers to focus on designing rather than debugging. it also avoids user frustration. 6) question 6: do you have any reservations about implementing more computer-based assistance in the design process? explain your answer.: this question asked participants if they have any reservations with regards to implementing more optimisation algorithms in their design processes. it was related to the first research question and was answered by 17 participants. each answer could be attributed to the human theme, though through various degrees. one student drew comparisons between other software such as cad and computational fluid dynamics, noting that the design process is already heavily computer based. an engineer and a student are concerned about the reliance that future engineers and designers will have on systems like gas. the engineer mentioned that these algorithms have "disengaged the brains of engineers" which threatens a long-term consequence of engineers that have poor design experience. two participants, a student and an engineer, cited job security as a reason why they would not want this technology implemented. this is a very real concern that needs to be addressed by properly explaining the intent of developing these tools. another engineer was very supportive of the idea, mentioning that they have been advocating for this kind of technology for the last 20 years. it is an accurate reflection of the challenge of getting new technology to be adopted by individuals and by organisations alike. 7) open-ended question summuray: the amount of mentions per theme are summarised in figure 3 and figure 4 . discrepencies in theme mentions can be explained by a varying number of participants in each category. the number of mentions also exceeds the total number of answers as some answers contained more than one theme. a common thread throughout participants responses is that there is a question of trust towards gas within industry. perhaps surprising is that the key to gaining this trust is not producing good results, but creating algorithms which explain the process they take in reaching a result. participants have expressed a desire to continue to remain in the design loop. this is at odds with the motivation of a portion of the ga community of removing humans from the loop [40] . it is clear we need to take a different approach to increase industrial uptake. the participants in this study have demonstrated through their answers that there is a general distrust towards gabased design in industry. 72% of answers expressed doubt when discussing whether designs produced by an optimisation algorithm could be trusted. their reservations have to do with the unproven state of these algorithms in their own personal experiences. however, respondents also recognise the potential of this technology, with 76% of respondents saying they could see the value of integrating gas somewhere in their process. of the respondents that expressed doubt, 69% of them noted that these algorithms could also help their design process. separately, participants noted that the inclusion of human expertise is vital for adoption. much to the surprise of the authors, the answers between the different groups (students, engineers, managers) and experience levels did not vary significantly. this can be seen in figure 3 and figure 4 . the different groups shared the same thoughts across a variety of questions, especially when considering the two research questions. the most notable example of this is that both a student and an engineer were concerned about their jobs being replaced or made redundant by automation. optimisation and iterative design are significant portions of the design process. when discussing their design process and the time spent at each stage, one participant said that in their experience "the detailed subsystem design is usually the longest stage" and that "an iterative evolutionary algorithm would speed up this process." this is in conjunction with the previous statement that this stage takes up 25% to 40% of the total design process time. recognising that trust is important in the development of new algorithms and the integration of such algorithms in industry is key to their adoption. participants noted that trust plays a big role in the adoption of new technologies. one participant had a clear mistrust of new algorithms. others mention multiple times that the need to be able to review the results and the decisions that an algorithm takes is a priority. when asked whether they had any reservations towards optimisation algorithms, three participants explicitly said yes. one of these participants went on to ask a series of questions about the ethics of the decisions made by an algorithm. questions included "who would be liable for a death or damage caused by a design made by this algorithm?" and "are we going to write a decisions rules book?" which clearly demonstrates that designers are not only aware of the decisions they make with respect to their design, but also to the wider consequences. the sophistication of the design process was also different across the range of participants. two participants had a more traditional approach when refining their design, opting for "trial and error" and "one factor at a time." these approaches are useful for exploring the entire design space and are a mix between designer experience and technology. however, they can be very time-consuming processes, especially on complex designs. while a design of experiments (doe) is generally suitable for proof that a global optimum has been achieved, a trial and error method is not. v. recommendations the participants in this study have shown with their answers that there is one key element which will determine the scale of adoption -trust. this principle is used as a foundation for the following recommendations. by trusting designers to know what's best for them, developers of new gas should engage with experts in creating solutions aimed at solving their optimisation problems. while the development of new algorithms is important in addressing different optimisation challenges, the application must go beyond benchmark tests and into industry for that algorithm to realise its potential. moreover, the reservations that participants had towards these algorithms point to a general need for algorithms to have suitable explainability and transparency. these criteria correspond closely to the requirements set out by those researching the ethics and law of ai [41] . the domain of evolutionary algorithms could coopt the proposed regulatory framework of ai as a starting point as these technologies become more prevalent in industry. throughout the survey, the need for human involvement in the development process of gas is brought up; it demonstrates a need for a user-centric approach. human-computer interaction (hci) is the field of study which concerns itself with researching the relationship between users and digital technology. this can first be observed in part 2 of the survey, where respondents identified a good ui as the most important factor when considering a design tool. the expectations from designers is that any additional tools that are made must integrate into their existing design process. this is articulated by a participant who needs an "intuitive set-up and an interface to existing tools." this can be seen as a direct answer to the second research question which enquires about the design requirements of domain experts. these tools need to also cater to novice users such as students. a user-friendly interface can lower the barrier of entry to gas. an engagement between hci researchers and ga researchers can further these algorithms towards a higher adoption rate in industry. the need for solutions to be developed in conjunction with the designers who will eventually be using these tools is evident in the answers of participants. integrating constraints in the design optimisation process was a recurrent subject among participants' answers. simplifying the problem down to something that could be modelled and optimised while maintaining a feasible enough design is a challenge one of the participants cited. the human aspect of design was also brought up by the participants by referencing the necessity for designer expertise in more complex designs. one of the participants also talked about aesthetic constraints. this is a constraint that cannot be modelled and relies solely on the experience and preferences of the designer. moreover, it should also serve as a reminder that any engineering design tool developed is not meant to cover every single aspect of the design process. the expectations of engineers needs to be set by researchers who develop these tools to determine what constitutes "state-of-the-art" with respect to this technology and what the limitations are of these techniques. analogously, gas are not the swiss army knife of design tools. engaging with designers and building their trust in gas can be done with the help of visualisations. a key aspect of building trust is to develop a level of understanding of the algorithms. a simple manner in demonstrating the performance of an algorithm is to visualise the resulting solution after each generation. this is especially useful when comparing two or more algorithms. if the algorithms themselves are considered as tools, then this would give designers an easy manner to comprehend which algorithm is better for their application. for some designers, it would also be beneficial to see the different solutions that a ga can produce. this can be especially useful for designers who also need to consider aesthetic constraints. it also leads to another consideration in the development of gas. the visualisation of algorithms is mentioned in the introduction section with work involving construction site layouts [18] . as recommended by castleberry & nolen [39] , personal bias is addressed. every effort has been made to mitigate the effects of bias when analysing, presenting, and discussing the data. with regards to pre-survey bias, the design of the study along with the questions were reviewed by the authors and amended to keep the study as objective as possible. as this survey was done entirely online, interview bias was not present. during the entire duration of the survey being available to respondents, the answers were not gleaned to prevent any bias during the analysis stage. of the 23 respondents that took part in this study, 7 could definitively be attributed as a professional connection to one of the authors (through answers provided to the question "how did you hear about this survey?") which introduces some level of bias. this was minimised by not asking respondents for any identifiable and traceable details. moreover, not a single answer contained any identifiable words or phrases. under a restriction-free scenario, participants for this study would have been interviewed in-person; due to covid-19, this could not be done. this did mean that the participants could not be prompted further when discussing their answers. as an example, some of the answers could not be coded due to their brevity so further detail from respondents would have been beneficial. in the future, video conferencing could be used instead of face-to-face interviews. a total of 23 participants were recruited through digital means to answer a survey. thematic analysis was performed on 6 open-ended questions, which yielded 3 major themes: human, technology, product. with regards to their current design processes, respondents noted that optimisation takes a significant portion of their time. respondents were generally aware of the source of inspiration from which evolutionary algorithms take their names, but lacked an in-depth knowledge of the subject. a majority of participants stated that they would implement these algorithms in their design process, although some still held reservations about their implementation. with respect to the two research questions posed, participants have demonstrated through their answers that there is a general distrust towards ga-based design, yet there is also an acknowledgement among participants that these algorithms could benefit the engineering design process. trust in these algorithms was one of the barriers to adoption. cost, manufacturability, and knowledge limitations were also mentioned as hurdles in the design engineering process. practitioners of ga tools want to understand how the algorithm made its decision. making tools for designers that are intuitive and whose functionality can be accessed easily by engineers is paramount; future ga interfaces should maximise engagement with designers. a clear communication channel between researchers and their end users can increase the adoption rate. trust is an important factor for designers. by allowing engineers to be in control of the process, engineers will be able to build a level of trust with the design tools. likewise, a human-centred approach will demonstrate to designers that these tools are not there to replace them. acknowledgment j.v. would like to thank members of the epic cdt for their continuous support. the particle swarm optimization algorithm: 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authors: lang, ariel j.; casmar, pollyanna; hurst, samantha; harrison, timothy; golshan, shahrokh; good, raquel; essex, michael; negi, lobsang title: compassion meditation for veterans with posttraumatic stress disorder (ptsd): a nonrandomized study date: 2017-12-22 journal: mindfulness (n y) doi: 10.1007/s12671-017-0866-z sha: doc_id: 11241 cord_uid: 2f73r2nv compassion meditation (cm) is a contemplative practice that is intended to cultivate the ability to extend and sustain compassion toward self and others. although research documents the benefits of cm in healthy populations, its use in the context of psychopathology is largely unexamined. the purpose of this study was to refine and initially evaluate a cm protocol, cognitively based compassion training (cbct®), for use with veterans with ptsd. to this end, our research team developed and refined a manualized protocol, cbct-vet, over 4 sets of groups involving 36 veterans. this protocol was delivered in 8–10 sessions, each lasting 90–120 min and led by a cbct®-trained clinical psychologist. quantitative and qualitative data were used to identify areas to be improved and to assess change that occurred during the treatment period. based on pooled data from this series of groups, cm appears to be acceptable to veterans with ptsd. group participation was associated with reduced symptoms of ptsd (partial eta squared = .27) and depression (partial eta squared = .19), but causality should not be inferred given the nonrandomized design. no change was observed in additional outcomes, including positive emotion and social connectedness. the results of this open trial support additional exploration of cm as part of the recovery process for veterans with ptsd. although empirically supported treatments are available for posttraumatic stress disorder (ptsd), most military personnel and veterans choose not to engage in these treatments or have residual symptoms after treatment completion (steenkamp et al. 2015) . a growing literature suggests that meditation may be useful in recovery from ptsd (see lang et al. 2012 for a review). data from clinical and non-clinical samples suggest that compassion meditation (cm) has a positive impact on positive emotion and social functioning, which are areas of difficulty for many individuals with ptsd. nonetheless, cm has yet to be evaluated for treatment of ptsd. cognitively based compassion training (cbct®) is a cm training program. it consists of a sequence of contemplative practices that are believed to cultivate the ability to extend and sustain compassion toward self and others (negi 2013) . cbct® combines present-moment practices (i.e., focused attention and open monitoring) with analytical contemplative methods, which encourage cognitive reappraisal and alteration of usual mental patterns to expand compassion. cm and similar approaches (e.g., loving kindness meditation [lkm] ) lead to increases in positive emotion in both clinical and nonclinical samples (for a recent meta-analysis see zeng et al. 2015) . the first published clinical application showed that lkm increased positive emotion and decreased negative emotion among individuals with negative symptoms of schizophrenia (n = 18; johnson et al. 2011) . more recently, an open trial with veterans with ptsd (n = 42) found that lkm was associated with decreased symptoms of ptsd and depression (kearney et al. 2013) , increased unactivated positive emotions, and decreased both activated and unactivated negative emotions (kearney et al. 2014 ). finally, evidence from functional mri shows activation in areas typically associated with positive affect (left medial prefrontal cortex and anterior cingulate gyrus) in an expert meditator engaged in cm (engstrom and soderfeldt 2010) . compassion-based meditative practices have also been suggested to alter social functioning in nonclinical samples. brief lkm practice was associated with a greater sense of social connectedness and positivity toward others based on explicit and implicit reactions in a laboratory setting (hutcherson et al. 2008 ). cm has also been linked to increased empathic accuracy and activation of associated brain circuitry (mascaro et al. 2013) , as well as increased altruistic behavior (galante et al. 2016; weng et al. 2013 ) and activation of brain regions associated with social cognition and emotion regulation, suggesting greater capacity to understanding the suffering of others (weng et al. 2013) . it is unknown, however, what effect cm may have on social connectedness in the context of psychopathology. both positive emotion and social functioning are potentially important targets in recovery from ptsd. ptsd is a maladaptive response to exposure to a traumatic event, characterized by unwanted re-experiencing of the event, avoidance, negative cognitive appraisals, and hyperarousal (american psychiatric association 2013). in addition to strong negative affect, ptsd is characterized by deficits in positive affect (litz and gray 2002) and avoidance of positive affective stimuli (clausen et al. 2016) . the importance of cultivating positive emotion is suggested by fredrickson's (2001) broaden and build theory, which posits that positive emotions enhance the ability to think flexibly and thereby build psychological resources that enable successful coping. in this way, positive emotions are believed to counteract the deleterious effects of negative emotions (fredrickson 2001) . high positive emotionality and intentionally inducing positive emotion have been associated with resilience, i.e., the ability to recover from negative experiences and to change based on situational demands (tugade and fredrickson 2004) and the ability to cope with highly stressful events (fredrickson et al. 2003) . thus, positive emotion induced by cm may independently reduce dysphoria, which appears to be the best predictor of problems in psychosocial functioning among those with ptsd (pietrzak et al. 2010 ). in addition, positive emotion has been shown to reduce fear-based reactivity (fredrickson et al. 2000) so may ameliorate ptsd-related anxious responding and hyperarousal. finally, positive emotions cultivated in cm may enhance one's ability to take another's perspective and foster closeness, thus providing social reinforcement and support. sharing of positive events, rather than providing support during negative events, is predictive of relationship health (gable et al. 2006) . problems with social functioning also are common among those with ptsd. individuals with ptsd have diminished ability to empathically connect with others (nietlisbach et al. 2010 ) and demonstrate poorer marital and family functioning and more impairment in interpersonal relationships and social activities (schnurr et al. 2009 ). social impairment is a predictor of chronicity of the disorder (marshall et al. 2006) , has been linked to increased risk of suicide for ptsd patients (panagioti et al. 2011) , and predicts return for additional care after initial treatment (fontana and rosenheck 2010) . social support, on the other hand, has been shown to buffer against development of ptsd and to predict improvement (e.g., ozer et al. 2008) . a greater sense of social connection is associated with better psychological and social functioning (hagerty et al. 1996) , including reduced anxiety and greater selfesteem (lee and robbins 1998) , and may have a protective effect against stress, depression, and ptsd (see, for example, cacioppo et al. 2006; cacioppo and patrick 2008) . thus, a greater sense of connection to and caring for others as encouraged by this practice may also translate into symptom reduction. for example, higher levels of altruism have been associated with lower levels of symptomatology in veterans with ptsd (kishonbarash et al. 1999) . the goal of the study presented herein was to adapt and collect preliminary data on the clinical impact of a modified version of cbct® for veterans with ptsd. an iterative refinement process using quantitative and qualitative feedback was used to refine the original cbct® protocol to reflect military/veteran culture and to enhance digestibility of the material and relevance to ptsd. pooled data from this set of groups are presented as an initial index of the feasibility and potential clinical utility of the intervention. participants participants (n = 36) were veterans with ptsd who were able to consent and willing to participate. co-occurring disorders such as depression, anxiety, or treated substance abuse or dependence problems were permitted provided that ptsd was the primary presenting complaint as determined by clinical interview. exclusion was on the basis of the following: (1) high risk for suicide or homicide that required urgent or emergent evaluation or treatment within the three months prior to study entry, (2) untreated substance abuse or dependence problems, (3) serious axis i mental disorders, such as psychotic disorders or bipolar type i, or serious dissociative symptoms (4) cognitive impairment that would interfere with treatment, (5) current circumstances that involve recurrent traumatization (e.g., currently engaged in a violent relationship), and (6) concurrent enrollment in any other treatment specifically targeting ptsd symptoms or social functioning (e.g., couples therapy). participants were allowed to continue current pharmacological treatment provided that no additional treatment response was expected and no changes were anticipated during the study period. the enrolled sample included 36 veterans, 31 of whom went on to begin the intervention (refer to fig. 1 for detailed study flow). the enrolled group was mostly male (n = 29, 80%) with an average age of 43.9 years (sd = 12.6). the group was also predominantly caucasian (n = 22, 61%), with 7 (19%) individuals identifying with more than one race, 2 native american/alaskan native, 3 african-american and 1 native hawaiian/pacific islander; twelve (33%) individuals identified as hispanic. on average, the group reported 13.9 years (sd = 1.8) of education, and eleven (30%) were currently employed. twelve (33%) veterans were married or had a permanent partner. the average number of lifetime traumatic events endorsed was 6.5 (sd = 3.0, range 2-13); the most commonly endorsed events were transportation accidents (n = 26), combat (n = 25), and physical assault (n = 20). the majority (n = 24, 67%) had served in the recent conflicts in iraq and afghanistan, but several major deployments since vietnam were represented. twenty-one (58%) individuals reported some type of combat injury, and most (n = 22, 61%) were receiving compensation from the va. this study was approved by the institutional review board of the va san diego heathcare system. potential participants were referred to the study by mental health providers or expressed interest directly in response to advertisement. interested individuals came to the clinic to complete informed consent, hipaa authorization, and the initial evaluation for eligibility. consenting, eligible individuals went on to complete the assessment battery. beginning with the first group meeting, weekly measures of ptsd, depression and alcohol use were gathered. the assessment battery was repeated at post-intervention. credibility was measured after the first session and satisfaction after the last session. finally, weekly diaries were used to quantify meditation practice. participants completed 8-10 classes, each lasting 90-120 min (refer to table 1 for the final schedule). all groups, which ranged in size from 6 to 8 at the start, were led by a licensed clinical psychologist (pc), who completed the cbct® teacher certification program, which includes a week-long retreat/workshop, a supervised practicum experience, and a post-practicum weekend workshop. as part of the practicum, audiotapes of sessions were reviewed by experts in cbct® (th, ln), and weekly supervision was provided to assure adherence to the intervention. intervention cbct® was designed to engender well-being through a set of meditative practices that aim to increase compassion, i.e., the sense of caring for the well-being of others and wanting them to be free from their difficulties and distress. developed at emory university in 2004 by professor negi, cbct® is based on techniques from the indo-tibetan buddhist tradition. as a secularized protocol, however, cbct® is independent from and supportive of any faith or belief system. the course is typically taught in weekly meetings supplemented by daily guided meditation recordings. group meetings for this study were structured approximately as follows: welcome agenda setting (5 min), homework review (15 min), participants' summary of past week's material (10 min), didactics (20 min), mindfulness exercise incorporating new concepts (15 min), meditation incorporating new concepts (15 min), homework assignment, and question/answer session (10 min). participants were provided with a written manual to facilitate their understanding of the material. homework involved daily meditation practice, which gradually increased from 6 min per day at the beginning to 15 min per day at the end. cbct® includes tools with the explicit aim of expanding compassion to be more inclusive, broadening the sense of in-group, and dampening out-group bias. broadly speaking, the structured sequence of exercises begins with stabilizing attention and developing presentmoment awareness then provides analytical practices to increase well-being and unbiased compassion toward self and others. participants begin by recalling a time or place in which they were safe and taken care of by another to prime a sense of safety and security to sustain this positive affect and increase the awareness of the value of compassion in their own lives. next, participants take part in an attention-training practicefollowing the sensations of the breath as they unfold-to promote attentional stability and mental clarity; a key objective of this is to learn to notice and release (bcatch and release^) distractions as they arise. this increased mental stability then supports present-moment awareness, sometimes called open monitoring. here, the attentional focus shifts to how mental experiences unfold from moment to moment, as the practitioners attempt to neither push away such experiences nor become overly involved in them. this practice improves calmness of mind and provides insight into habitual mental patterns. the stability and insights from these exercises then support the analytical reflections that follow. the next topic is to examine the nature of distress and dissatisfaction in one's life and cultivate more realistic and constructive attitudes in the face of difficult circumstances. with an emphasis on approaching one's situation with increased self-kindness, the practitioner strengthens the determination to replace unhelpful perspectives and attitudes with more constructive ones, thus increasing a sense of self-efficacy and promoting a realistically based optimism. with a greater caring for self and the insight that constructive attitudes and perspectives are essential to enhancing wellbeing, cbct® then focuses on attitudes and perspectives that are directed toward other people. humans are fundamentally social creatures; relating constructively and positively with others is central to anyone's well-being. thus, the participant goes on to examine how all people, despite many differences, share a fundamental desire for being well, flourishing and avoiding distress and dissatisfaction. this practice leads to a greater capacity to see others as like oneself at a basic level, setting the stage for greater empathic response and more inclusive compassion. next, participants spend time reflecting on how their own well-being is dependent on the efforts of others, thus cultivating an appreciation for the received kindness of others, intended or unintended. these teachings are meant to generate authentic gratitude, moderate unrealistic attitudes of independence and isolation, and generate a deepening affection, even for those outside one's social group. the practice concludes with a focus on the arising and sustaining of compassion toward others. here, the participant embraces others as deserving of understanding and care because everyone-including loved ones, but also strangers and even difficult people-has inherent value and the equal right to pursue freedom from suffering. by focusing on the difficulties and distress experienced by so many, a deeper empathic response is evoked, and when supported by the inner strength introduction of positive cognitive reflection into stabilized meditation. superheroes are used as an example of accepting flaws. expecting perfection or self-blaming is a barrier to self-awareness and compassion. introduction to the idea that that all beings want to avoid suffering and find satisfaction in life. clarity in understanding that it is behavior and not humanity that can be inappropriate assists participants in building a more open acceptance of others. session 7: appreciation and gratitude ordinary objects, talents and skills are shown to have been obtained through the contributions of both known and unknown others. this creates an awareness of interdependence and builds appreciation and gratitude for the human family. in the context of interdependence (i.e., others who do not necessarily like them or even know them are continually helping them to live their everyday life), it becomes easier to see that all people have bad habits. understanding that change is difficult for all people and that we are not completely aware of the underlying issues others have helps participants to wish to relieve suffering for others. session 9: putting it all together (1) review and relapse prevention. helps participants to understand the links between the sessions and allows participants to create meditation cards to keep to support coping when they might not have access to guided meditations. personalized meanings of the sessions are shared among members. session 10: putting it all together (2) coping cards for applying meditation in everyday actions are created in class. homework exercise reviewed to provide a springboard for brainstorming and understanding. lessons on how to avoid compassion fatigue and continue to build positive emotions are taught. developed earlier in the practice, this empathy is transformed to become an engaged and motivated sense of caring for others and lead to more spontaneous and consistent prosocial thoughts and behaviors. protocol refinement the cbct® program was manualized before the initial group based on clinical experience with veterans with ptsd (ajl, pc, me) in collaboration with cbct developers (ln, th) to create the veteran version, cbct-vet. initial modification was aimed at increasing military/veteran relevance and facilitating use by individuals with psychopathology. the guided meditations encourage emotional experiences and thus could be difficult for individuals with ptsd to tolerate. the therapist spent time in session talking about this possibility and how to handle it and made herself available between sessions as needed. veterans were provided with strategies for managing flashbacks or strong emotions that are consistent with the practice, e.g., taking a deep breath and reseating oneself, then returning attention to the breath. similarly, difficulty focusing could be handled by placing hands on one's belly (to get a physical reminder of breathing) and breathing until the experience passed. in addition, we assumed little to no exposure to meditation to make the program accessible to any veteran with interest, so we developed additional materials to facilitate understanding of meditation. education in the science of compassion, including brief videos to illustrate difficult concepts, supplemented straightforward didactic materials that were provided in the participants' manuals. in addition, we believed that it was important that veterans apply meditation practices to ptsd-relevant experiences, so homework was designed to encourage and help trouble-shoot that process. the language from the original cbct® guided meditations was retained to the extent possible to maintain consistency of the intervention, although adaptations to reflect an 8th grade reading level and veteran-relevant terminology were important to foster accessibility of the material. in addition, group discussion was used to enhance understanding and application of the material. finally, we were concerned that the group nature of the intervention, which is the standard for instruction in meditation, could create a barrier to individuals who typically prefer one-on-one therapy. on one hand, compassion is often enhanced by exposure to experiences of others shared in the class and veterans can help each other through the struggles and joys of learning meditation. on the other hand, individuals who have experienced trauma are frequently uncomfortable with discussing symptoms or traumatic experiences in a group setting. to manage this concern, potential participants were helped to understand that the focus of the class was learning meditation rather than discussing traumatic events. it is our aspiration, however, that the skills developed in the group will facilitate one's ability to discuss and cope with distressing experiences, such as during trauma-focused psychotherapy. to the extent that traumatic events were brought up by group members, the group leader gently redirected the discussion from trauma specifics to expressing the ways in which they were cognitively or emotionally impacted while meditating. participants were encouraged to remain after class to discuss specific concerns that might not be central to the group's current work, and referrals to additional services were provided as needed. the treatment development team (al, pc, me, th, ln) made subsequent refinements to the manual after the completion of each group based on therapist input, qualitative interviews, and quantitative data. the changes, which were evaluated based on subsequent participant feedback, were as follows. the groups were reduced from 120 to 90 min to reflect participant comments about the group seeming too long. veterans requested more time for group discussion and cohesion-building, so classes were reviewed to balance presenting material and exercises with group process. meditation exercises also were reconfigured to involve paired work or group interaction to foster a feeling of group cohesion while maintaining the integrity of the intervention's goals. to address perceived deficits in conceptual understanding of the intervention that we identified in the qualitative interviews, veterans were asked to bteach^previously presented concepts to other group members with others being encouraged to chime in if there were other items that might facilitate learning. the class was extended from 8 sessions to 10 to make up for the change in session length and to allow time for discussion and review/ skill consolidation. one concern that may be unique to this population was that tinnitus was experienced as louder when there were silences in the recorded guided meditations. these participants were reminded that this experience was common for them throughout their lives, that this was their bnew silence,^and that if distracted by the ringing, they could bring their attention back to the breath. finally, some veterans had difficulty accessing the guided meditations because of unfamiliarity with technology. to manage this, study staff took a more active role in providing support. table 1 presents the final intervention outline. demographic information was collected via self-report, and the montreal cognitive assessment (moca; nasreddine et al. 2005 ) was used to screen for cognitive impairment. a score lower than the age/education-adjusted cutoff for psychiatric populations (gierus et al. 2015) triggered additional neuropsychological evaluation and clinician clearance to participate. the mini international neuropsychiatric interview (mini 6.0; sheehan et al. 1998 ) was used to establish psychiatric diagnoses, including primary diagnosis, and to screen for suicide/homicide risk. the dissociative experiences scale (des; bernstein and putnam 1986) was used to identify problematic dissociative symptoms, and the life events checklist (weathers et al. 2013a ) was used to inventory lifetime trauma exposure. finally, each participant was queried about use of mental health services. issues of clinical concern were further evaluated by clinician review of the electronic medical record. the feasibility of the approach was evaluated based on participant attrition, time spent in practice, credibility as measured by a 3-item measure adapted from (borkovec and nau 1972) , satisfaction as measured by the client satisfaction questionnaire (csq-8; attkisson and greenfield 1994) , and qualitative interview. qualitative interviews were conducted by an experienced qualitative interviewer (sh) with the aim of learning about the understandability, applicability, and efficacy of cm for this group. interviews were conducted by phone within 2 weeks of the conclusion of the last session attended to give participants an opportunity to reflect on their experience and learning. each interview lasted approximately 30 min. the interviews were recorded and notes were taken by the interviewer to capture participant responses. the semistructured interview guide posed nine reflective questions that focused around the (a) experience of practicing cm, (b) potential changes noted from skills they had learned at each intervention session, and (c) personal changes that participants perceived in managing both pleasant and unpleasant situations in their life because of their cm training. clinical outcomes were measured on a weekly basis using the dsm-5 version of the ptsd checklist (pcl-5; weathers et al. 2013b) , the patient health questionnaire depression items (phq-9; kroenke et al. 2001) , and the consumption items from the alcohol use disorders identification test (audit-c; bush et al. 1998) . weekly measures were also used by therapists to monitor participant safety, as is typical practice in ptsd treatment. emotional experience was assessed weekly using the modified differential emotions scale (mdes; fredrickson et al. 2003) , which consists of daily ratings of the strongest experience of 20 specific emotions in the preceding 24 h. the mdes is scored to quantify positive and negative emotions separately. in addition to the weekly measures, the 20-item social connectedness scale-revised (scs-r; lee et al. 2001 ) and the short form of the self compassion scale (scs-sf; raes et al. 2011) , which is comprised of six two-item subscales: self-kindness, common humanity, mindfulness, self-judgment, isolation, and overidentification, were administered before and after treatment. the sample description and analysis of clinical change is based on data that were pooled across the four groups of six to eight participants. although there are differences in terms of content and therapy time within the groups, we believe that the aggregated data are informative in terms of our goals of evaluating the feasibility and clinical impact of cbct-vet as the fundamental intervention (cbct®) remained the same. a flowchart was generated to capture the flow of subjects throughout the study (refer to fig. 1) . descriptive statistics were used to characterize the participants before treatment. the collection of qualitative data was useful to explore details about participant perceptions of the intervention. specifically, the qualitative data provided a contextual understanding of differences in participants' reactions and how that influenced their adaptability to the dynamics of the intervention, as well as ways in which they negotiated the practice of cm for stressful life situations. descriptive statistics were used to characterize the sample. mixed effects models were applied to measures that were captured weekly, and repeated measures analysis of variance (anova) was used for pre-post change. effect sizes (partial eta squared) were calculated based on the first and last completion of each clinical measure. at the first intervention session attended, participants had a mean pcl-5 score of 45.2 (sd = 16.5; n = 30 because one participant elected not to complete this measure) and a mean phq-9 score of 15.6 (sd = 6.1). all had a ptsd diagnosis with the exception of one individual; this person had a primary complaint of subsyndromal ptsd (pcl-5 = 40) with clinically meaningful distress and impairment, so an exception to eligibility criteria was made. the rates of co-occurring diagnoses were as follows: major depressive disorder (n = 13, 42%), panic disorder (n = 5, 16%), social phobia (n = 8, 26%), and obsessive compulsive disorder (n = 4, 13%). before treatment, eight people screened positive for potentially problematic drinking behavior based on the audit-c. seven participants had completed one or more empirically supported psychotherapy for ptsd in the past, and 15 veterans were taking one or more psychotropic medication. figure 1 presents attrition throughout the study. eighty-eight percent of those who were assessed for eligibility enrolled in the study; this high rate likely reflects the use of clinician referral and relatively broad eligibility requirements. a significant number (5/36) withdrew before beginning treatment. those who completed six or more sessions (n = 19, 61% of those who began treatment) were exposed to the essentials of the intervention, and those who completed four to five sessions (n = 5; 16%) were presented with some concepts but not the full intervention. those who completed 1-3 sessions (n = 7; 22%) did not receive a meaningful introduction to the practice and, although they were asked to provide data at the end of their involvement, none of them did so. completers did not differ from drop-outs on any clinical or mechanistic measures (all p > .05). participants generally cited logistical reasons for not completing the group (i.e., surgery, moving, untenable commute, family emergency), although two stated that the group did not meet their expectations. credibility questions were rated on an 8-point scale, with higher numbers indicating greater credibility. average ratings were as follows: 6.3 (sd = 1.5) for how logical the intervention seems for ptsd, 5.9 (sd = 1.4) for confidence that the intervention will help with functioning, 5.9 (sd = 1.4) for confidence that the approach will help with ptsd, and 6.0 (sd = 1.7) for confidence in referring a friend to the program. the range of scores for those who completed 1-3 sessions was 6.14-6.29 whereas the range for those who completed 4 or more sessions was 5.90-6.48. the average csq-8 score was 25.5 (sd = 4.0, range 12-29, instrument range 8-32). the average number of minutes participants reported practicing each week (and percent of attendees turning in homework records) were as follows: 38 min (75%) during week 1 (target 36 min), 72 min (80%) during week 2 (target 72 min sessions 2-4), 68 min (74%) during week 3, 81 min (89%) during week 4, 85 min (80%) during week 5 (target 90 min sessions 5-10), 77 min (53%) during week 6, 60 min (67%) during week 7, 90 min during week 8 (2/2 participants reporting), and 90 min during week 9 (2/2 participants reporting). based on the qualitative interviews, participants felt that 120 min was too long for the sessions; once group length was reduced to 90 min, participants no longer suggested shortening groups. sessions were reconfigured to allow for additional discussion time because several participants were dissatisfied with the way that time was divided among presentation of new material, discussion, and practiced meditation. many mentioned that it was at least 3-4 weeks before people felt comfortable in the group, and they worried that because of the time needed to adjust, they had lost time in adequately learning the initial materials, which were built upon in subsequent later sessions. on the other hand, some felt that it was challenging to give everyone a chance to talk during informal discussions, particularly after the group became comfortable. finally, most participants stated that different learning levels in the class might have been better supported by providing more practice time with new material during the sessions to make some of the homework easier to absorb. this was addressed by having participants summarize past sessions and by using the final two sessions to consolidate learning. figure 2 depicts the change over time in ptsd and depression. the effect sizes, calculated based on change from the first to last session attended, were partial eta squared of .27 for ptsd and.19 for depression. these would typically be interpreted as large effect sizes (cohen 1988) . the change in ptsd symptoms (pcl-5 total score), f(1,23.8) = 8.0, p < .05, and depression (phq-9 total score), f(1,20.0) = 4.4, p = .05, reached statistical significance, but audit-c did not, f(1,20.9) = 2.3, ns. no change was observed in positive emotion (mdes positive), f(1,20.6) = 2.7, ns, or negative emotion (mdes negative), f(1,21.5) = 0.0, ns, a presented in fig. 3 . data from the scs-r and scs-sf, which are similarly unchanged, are presented in table 2 . several participants described an increased sense of peace and resilience during the qualitative interviews: for example: bi react a little different to certain things…i'm a lot calmer and i try to think about it first. i try to think about how i'm feeling and why.b my tendency before is that i'd get worked up too easily and act out in anger instead of rationally.b the meditation training had a very high calming ef-fect…i used the breathing to keep me from getting agitated or if i was feeling anxious or stressed in class.â lso consistent with the intention of the intervention, participants expressed differences in the way that they think about others and themselves. exemplars of this are as follows: bi feel a little bit more compassion for other people's feelings and mine also. i try not to be so judgmental and give them the benefit of the doubt.b i was the kind of person that i wouldn't look or smile at people but now i try to be more tolerant and be friendlier. i'm trying to open up a little more to people i don't know.b we learned in class that everyone is just trying to be happy and that really clicked for me.ô thers, however, suggested to us that the group began changes that were not complete. for instance: bi spent a lot of time with unpleasant thoughts. i am able to bcatch and release^a little easier and filter through what i want to be thinking. i still feel i have a long ways to go but i think i can do it.b i'd like to say that i appreciate people more but i don't.b i'm not letting go of things and giving people the benefit of the doubt. i haven't improved in those things but at least i'm aware of it.b i don't think i communicate with people any different yet, but i am learning to refocus in my environment to not react.m this project adapted a standard cm program to meet the needs of veterans with ptsd. the resulting manualized protocol, cbct-vet, appears to have potential in supporting recovery among veterans with ptsd. the now ten-session protocol was implemented in a series of four groups within a general va mental health clinic, involving participants who are generally representative of those who seek care at the facility. this open trial suggests that compassion meditation may help alleviate symptoms of ptsd and depression, although causality cannot be concluded based on this study design and the mechanism by which change occurs is unclear. the intervention was received well by participants based on ratings of credibility and satisfaction as well as qualitative interviews. the program was feasible to implement, although 69% completion is on the low end of what is typically observed in veterans with ptsd (e.g., polusny et al. (2015) , who had 78% completion of mindfulness-based stress reduction in their recent randomized trial). our conjecture that cm increases positive emotion, which was based largely on data from non-clinical samples, was not consistent with what we observed in our sessions 9 and 10 are not depicted because the very small sample size in those sessions (n = 2) creates a misleading visual weekly emotion measure. qualitative data, however, suggest that participants experienced a greater sense of calm because of the intervention. thus, it is possible that the set of positive emotions measured by the mdes (i.e., joy, gratitude, contentment, interest, hope, pride, amusement, inspiration, awe, love) were relatively less impacted than a sense of peace and calm. in the future, considering emotional arousal and valence dimensionally, as suggested by in the circumplex model of emotions (russell 1980) , may be helpful in better understanding the emotional impact of cm. kearney et al. (2014) , for example, found some differences in terms of activated and unactivated emotions using the circumplex measure of emotion in their open trial of lkm for ptsd. it is also possible that change in positive emotion did not occur within the timeframe measured within this study but may become evident with continued practice. longerterm follow-up may be important in terms of understanding the nature of emotional change associated with compassion meditation practice. similarly, our measures of social connectedness and self-compassion were apparently unchanged by group participation. although the power is lower for these tests than for measures collected weekly, mean values, fig. 3 change in positive and negative emotions over the period of the group. note: mdes: modified differential emotions scale. sessions 9 and 10 are not depicted because the very small sample size in those sessions (n = 2) creates a misleading visual which changed very little, do not suggest that we simply lacked power to detect change. our qualitative data suggest that participants were beginning to change in terms of the way that they think about themselves and others but that such changes would take time. further, social connectedness reflects one's social network; once attitudes about others change, it likely takes time additional time to change one's relationships. it is possible that different measures (e.g., of empathy or social bias) may better reflect this early change than did the measures we used. another possibility would be to offer continuing practice to allow changes to consolidate, which was a request of several of the participants who completed the entire program. the question remains as to what led to the large effect size decreases in ptsd and depression that we observed over the course of the groups. it is always possible that non-specific factors, such as group cohesion (ellis et al. 2014) or hope (gilman et al. 2012 ), led to improvements. although the data should be interpreted with caution due to the small sample size, it appears that much of the change occurred in the first 3 weeks when meditation was being taught but the contemplative work about compassion had yet to be presented. this raises the possibility that the general meditation skills, such as mindfulness, could be leading to the observed improvement. this would be consistent with work by owens et al. (2012) , who linked improvements in acting with awareness to decreased ptsd symptoms. we did not observe a change in the abbreviated mindfulness measure that was used in this project, however, so more thorough assessment may be useful in the future. finally, qualitative data suggest that the group may have improved emotion regulation, as people described being less likely to be triggered and more able to let things go. this possibility, too, is worth investigating as we try to understand the psychological mechanisms at work. in summary, this trial provides strong proof of concept evidence for the use of cm to support recovery among veterans with ptsd. a diverse sample of veterans enrolled in the program and provided productive feedback about the groups. we found large effect size changes in symptomatology, but a randomized trial is needed before drawing conclusions. the nonrandomized design of this study leaves open the possibility that observed changes are due to other factors, such as the passage of time, social support or nonspecific aspects of the intervention. the small sample size and self-selection into the trial are also significant limitations. the observed symptom change is based on self-report measures; in future studies these should be complemented by clinician administered tools, as is the gold standard in ptsd trials. weekly symptom assessment is standard for ptsd treatment; nonetheless, the frequency of use of these tools may influence participant responding. future studies should include alternative measures before and after treatment. finally, the treatment manual was modified over the course of this study, so the results reflect application of the general approach by our therapist rather than application of a manualized approach; this issue should be addressed in future studies. author contributions ajl: designed and executed the study, assisted with the treatment development, and wrote the paper. pc: conducted meditation groups and assisted with treatment development. sh: collected and analyzed qualitative data and assisted with treatment development. th: assessed fidelity to cbct and assisted with treatment development. sg: analyzed quantitative data and contributed to the writing of the paper. rg: acted as the research assistant and assisted with treatment development. me: assisted with treatment development. ln: developed cbct and assisted with treatment development. funding this study was funded by national institute for complementary and integrative health r34 at007936-01a1 (pi, lang). ethical approval irb approval for this study was provided by the irb of the va san diego healthcare system. all procedures performed in this study involving human participants were in accordance with the ethical standards of the institutional review board and with the 1964 helsinki declaration and its later amendments or comparable ethical standards. informed consent informed consent was obtained from all individual participants included in the study. diagnostic and statistical manual of mental disorders the use of psychological testing for treatment planning and outcome assessment development, reliability, and validity of a dissociation scale credibility of analogue therapy rationales the audit alcohol consumption questions (audit-c): an effective brief screening test for problem drinking loneliness: human nature and the need for social connection loneliness as a specific risk factor for depressive symptoms: cross-sectional and longitudinal analyses combat ptsd and implicit behavioral tendencies for positive affective stimuli: a brief report statistical power analysis for the behavioral sciences the importance of group cohesion in inpatient treatment of combat-related ptsd brain activation during compassion meditation: a case study war zone veterans returning to treatment: effects of social functioning and psychopathology the role of positive emotions in positive psychology. the broaden-and-build theory of positive emotions the undoing effect of positive emotions what good are positive emotions in crises? 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changes in mindfulness skills and treatment response among veterans in residential ptsd treatment predictors of posttraumatic stress disorder and symptoms in adults: a meta-analysis pathways to suicidal behavior in posttraumatic stress disorder structure of posttraumatic stress disorder symptoms and psychosocial functioning in veterans of operations enduring freedom and iraqi freedom mindfulness-based stress reduction for posttraumatic stress disorder among veterans: a randomized clinical trial construction and factorial validation of a short form of the self-compassion scale a circumplex model of affect posttraumatic stress disorder and quality of life: extension of findings to veterans of the wars in iraq and afghanistan the mini-international neuropsychiatric interview (mini): the development and validation of a structured diagnostic psychiatric interview for dsm-iv and icd-10 psychotherapy for military-related ptsd: a review of randomized clinical trials resilient individuals use positive emotions to bounce back from negative emotional experiences the life events checklist for dsm-5 (lec-5) the ptsd checklist for dsm-5 (pcl-5) compassion training alters altruism and neural responses to suffering the effect of loving-kindness meditation on positive emotions: a metaanalytic review key: cord-313218-4rbxdimf authors: narushima, miya; kawabata, makie title: “fiercely independent”: experiences of aging in the right place of older women living alone with physical limitations date: 2020-09-09 journal: j aging stud doi: 10.1016/j.jaging.2020.100875 sha: doc_id: 313218 cord_uid: 4rbxdimf this study explores the experience of aging among older canadian women with physical limitations who live by themselves. while aging in place has been a policy priority in rapidly greying canada, a lack of complementary public supports poses challenges for many older adults and their family members. employing a qualitative methodology, and drawing from the notion of aging in the right place, we collected personal narratives of 12 women (aged 65 to 92) in two geographic areas in ontario, including residents of regular houses, apartments, condominiums, assisted living and community housing for seniors. through thematic analysis, we identified four overarching themes: 1) striving to continue on “at home”, 2) living as a “strong independent woman”, 3) the help needed to support their “independence”, and 4) social activities to maintain self. our findings illustrate how, despite their mobility limitations, older women can change their residential environment and their behavior by deploying the coping strategies and resources they have developed over time. however, we also found that older women are largely silent about their needs, and that experiences varied depending on life histories, health conditions, and the availability of supports in their wider environment (home care, alternative housing options, accessible transportation, opportunities for social and physical activities). we hope these findings will incite further studies and discussion to help make aging in the right place a real choice for anyone who wishes to do so. population aging in canada will keep accelerating over the next decade. the ratio of "senior citizens" (aged 65 years and older) is expected to grow from 17.5% in 2019 to 22.7% by 2031 (statistics canada, 2019) . "old-old" canadians in their late 90s and above are among the fastest growing age group (hudon & milan, 2016) . like many countries, canada's policy response to this demographic change is the promotion of aging in place, generally understood as being able to remain in familiar homes or communities for as long as possible. the premise is to promote independent living in later life, while shifting care for the older adults from institutions to home and community (dalmer, 2019; lehning, nicklett, davitt, & wiseman, 2017) ; a shift long criticized by social gerontologists for being part of the devolution of aging and long-term care policies. policy makers have largely supported this strategy as a cost-effective long-term care alternative. more than anyone, however, it is older adults themselves who are in favor of the idea. aging in place has become common in canada. comparing the 2011 and 2016 censuses, the ratio of people aged 65 and older living in "collective dwellings" (e.g., assisted living, supportive housing, retirement residences, seniors' apartments, continuum care facilities, and nursing homes) has dropped from 7.9% to 6.9% (garner, tanuseputro, manuel, & sanmartin, 2018; statistics canada, 2012) . given the increasing numbers of older canadians, one would expect this number to grow, not decline. the 2016 census found only 5.0% of seniors had moved in the past year, a much lower rate than the general population (13.0%). this should not, however, be assumed to reflect older adults' satisfaction with their housing. in fact, almost a quarter of seniors reported their housing as "below standard" in terms of either affordability, adequacy, or suitability (federal/provincial/territorial ministers responsible for seniors, 2019). although health status among older adults is heterogeneous, chronic diseases and physical limitations increase with advancing age. more than three-quarters of canadians aged 65 and older reported having at least one chronic condition, and one quarter reported three or more. one out of four of those aged 85 and over reported a need for support in instrumental activities of daily living (iadl), while one in ten needed support in activities of daily living (adl). like the rest of the world, older women are disproportionately represented in these groups (canadian institute for health information, 2011) . older women in general are more likely to face challenges since women live longer and are more likely spend their later years with mobility problems and pain (bushnik, tjepkema, & martel, 2018) and nearly twice as likely to live alone than their male counterparts. the 2016 census found 26.0% of seniors lived alone, 68.0% of who were women (tang, galbraith, & truong, 2019) . in addition, women living alone comprised 57.0% of seniors with "core housing needs" (federal/ provincial/territorial ministers responsible for seniors, 2019). given these demographic, health, and socio-economic trends, more research on the experience of aging in place among older women, especially those living alone with physical limitations, is needed (gonyea & melekis, 2018) . from "aging in place" to "aging in the right place" the conceptual development of aging in place began when american environmental gerontologists (lawton & nahemow, 1973) introduced the "ecological model of aging" to examine the relationship between people and their environments. in this model, an older person's functioning is determined by the "fit" between "personal competences" (e.g., physical, psychological, and social functions) and "environmental characteristics" (e.g., the immediate and wider environments). as changes happen in either or both, older adults can try to adapt their physical and social environments to find a comfort zone by deploying their resources (greenfield, 2011; lawton & nahemow, 1973; peace, holland, & kellaher, 2011; stafford, 2016) . this theoretical framework helps us to understand aging in place as a dynamic process of personenvironment interactions. wahl, iwarsson, and oswald, and their collogues in germany and sweden have extended this framework to, "maintaining the highest autonomy, well-being, and preservation of one's self and identity as possible, even in the face of severe competence loss" (wahl, iwarsson, & oswald, 2012, p.310 ). this process is influenced by two concepts: "belonging" and "agency". belonging involves an older person's sense of connection with others and the environment and preserved identities over time. agency refers to sufficient control of their environment to maintain autonomy. belonging grows in importance as people get older, especially when they develop functional impairments (oswald, wahl, schilling, & iwarsson, 2007; wahl et al., 2012) . this model reminds us of the benefits of taking a life-course perspective to understand the experience of aging in place. in the same vein, golant (2011 golant ( , 2015 , an american environmental gerontologist, has put forward the notion of aging in the right place. pointing to the unequal capabilities and resources among older adults, golant (2008 golant ( , 2015 criticizes how aging in place has been promoted as a cultural imperative in america, emphasizing an individual's self-reliance in sustaining a healthy active lifestyle. even when older adults have chronic health problems, disabilities, or cognitive deficits, he argues, if they are offered "enabling residential and care opportunities that strengthen their coping skills to achieve their evolving needs and goals", they can still "age successfully" (golant, 2015, p.353 ). golant thus advocates shifting public discourse, and older adults' thinking, from aging in place to aging in the right place, which includes expanding the various alternative housing options being consideredsuch as group housing, active adult communities, senior apartments, assisted living residences, continuum care, and the like. in this model, regardless of residential type, older adults can achieve "residential normalcy" where they feel comfortable, competent, and in control. older adults may use various coping strategies when their residential normalcy becomes incongruent. moving to alternative housing such as assisted living, active adult communities, and nursing homes can be seen as adaptive responses to aging. golant (2015) also noted that enriched coping strategies are products of the resilience of both older persons and their environments. despite this theoretical development, the public discourse surrounding aging in place in canada seems to have stagnated. for example, in a public guide issued by the federal government, "aging in place" is defined as "having access to services and the health and social supports and services you need to live safely and independently in your home or your community for as long as you wish and are able" (federal/provincial/territorial ministers responsible for seniors, 2015, p.1). the guide also notes that an individual can achieve this goal through early planning in such areas as home, community, transportation, care and support services, social connection, healthy lifestyle, finance, and information. as dalmer (2019) has noted, such neoliberal rhetoric frames aging in place as "a matter of choice" that can be responsibly managed by individuals. given the lack of affordable housing alternatives and the unmet need for long-term home care services for many older canadians, however, this so-called choice is often illusory. as mentioned, according to the 2016 census, only 6.8% of canadians aged 65 years and older lived in "collective dwellings," including nursing homes (the most common) and other alternative senior residences such as assisted living and retirement homes. this suggests that moving to alternative housing, as advocated by aging in the right place, is still uncommon in canada. this is partly due to a lack of affordable senior residences. in ontario, the average monthly rent for a standard space for a resident without high-level care needs was $3758 canadian in 2018 (canada mortgage and housing corporation, 2019). given seniors' average annual income -$48,800 for men and $34,900 for women (statistics canada, 2020) -alternative housing is unaffordable for most older canadians, especially women. as more and more older adults age in place, their homes and communities increasingly become locations for health and social care services (hereafter "home care"). since long-term home care is not universally insured under the canada health act, older adults who don't qualify need to resort to community agencies that often require a co-payment or privately hire help (armstrong, zhu, hirdes, & stolee, 2015; gilmour, 2018; government of ontario, 2019; johnson et al., 2018; lee, barken, & gonzales, 2018) . according to the 2015/2016 canadian community health survey, over one-third (35.4%) of people with home care needs did not have their needs met, especially among those with home support services for maintenance of daily living (gilmour, 2018) . the current policy of aging in place needs more complementary public supports to reduce the challenges facing many older adults and their families. it is within this context that we explore the experiences of aging in place among older canadian women with physical limitations who live alone. our research questions include: 1) what is it like to live at "home" alone for older women with physical limitations? 2) what support do they receive and how? and 3) what are the enabling and disabling factors for their independent living? this study employed a qualitative research methodology (merriam & tisdell, 2016) , more specifically, combining personal narrative analysis (maynes, pierce, & laslett, 2008) with a narrative gerontology approach (de medeiros, 2014) . a qualitative approach lets us explore inductively how older women construct and make sense of their experience of aging in place (merriam & tisdell, 2016) , connecting their individual experience and life trajectories with broader cultural and social forces (maynes et al., 2008) . this reinforces what narrative gerontology advocates: listening to older people's lives as stories to understand their social world -personal, interpersonal, structural and cultural (de medeiros, 2014) . this study is part of a larger study, and ethics clearances were obtained from the research ethics boards of both researchers' universities. we recruited participants in two areas (a large metropolitan area and a medium sized city) in southern ontario. the criteria for inclusion were: women 65 years and older, who lived by themselves at home with chronic physical conditions, and who were using or had used home care services. following the notion of aging in the right place, we included both regular house, condominium, and apartment, as well as alternative housing such as assisted living and community housing for seniors. we created a flyer, noting we were "looking for participants in a research study to learn their experience of and opinions about living with chronic physical conditions." approximately 70 flyers were either posted in their residences or directly delivered to potential participants through personal support workers (psws) in collaboration with five different community organizations. recruitment was harder than we had expected. since only two participants voluntarily called back, we asked our participants, colleagues, and friends to deliver the flyer to whoever might meet the criteria. eventually, we had 15 interviewees. although every interview will be used in our larger study, 12 participants met all the criteria for this study. the 12 participants ranged between 65 and 92 (the average age was 83), and lived in various residential types in varying states of health. all have been given pseudonyms (see participants' profiles in table 1 ). the data collection was conducted in the spring and summer of 2017. the first author and a student research assistant conducted all interviews together. eleven interviews were conducted in participants' homes and one was in a public space. visiting their residences let us observe their daily living and neighborhood environments. each interview lasted from 90 to 120 min. we began by asking participants to tell us their life histories, followed by questions about their daily and weekly routines, current physical condition, strategies and challenges for managing their independent living, the support they receive, and their opinions about aging in place in general. since one chinese immigrant participant (hong, 90) had difficulty speaking english, her daughter (lin, 64) joined the interview as a translator, also providing some of her own insights as a family carer. following each interview, we provided a gift card of $30 with a thank you note. then the two interviewers debriefed each other, recording what they had noticed in the field notes. all interviews were audio recorded, transcribed verbatim, and sent to participants to check accuracy and to modify if requested.the twelve transcripts comprised 281 pages in total. following the steps of thematic analysis (merriam & tisdell, 2016) , we started open coding by reading the first participant's data set (transcript and field notes), then underlined any segments that might be meaningful and attached labels (i.e., code and themes). next, we moved to axial coding by sorting these codes and themes into more comprehensive groups (i.e., categories). then, we created a matrix to display the categories, themes, and supporting quotations for the first participant transcript. we went through the same procedures for the second data set, and compared the two matrices to create a master list of crosscase categories and themes. this master list was used as a basis for analyzing the other participants' data. comparing all 12 participants' matrices, we generated four overarching themes as findings. to increase trustworthiness, our design included data triangulation, member checking of interview transcripts, a reflexive journal, and peer debriefing with research team members (creswell, 2013; merriam & tisdell, 2016) . we found the following four overarching themes: 1) striving to continue on "at home", 2) living as a "strong independent woman", 3) the help needed to support their "independence", and 4) social activities to sustain self. these overarching themes contain several subthemes. the first theme involves our participants' efforts to live in their homes comfortably and safely. as shown in table 1 , many participants had lived in the same residence for decades, while a quarter had moved in the past four years due to changes in their mobility or marital status. in any event, all participants seemed comfortable in their residence, which they called "home". the first thing that we noticed was that these homes preserve their personal histories and identities. their well-kept living rooms were stuffed with vintage furniture, family photos, art, crafts, books, instruments, souvenirs, plants, pets, etc. participants four participants mentioned they might have to move in the future when they could no longer take care of themselves. yet their narratives suggested the difficulty of moving to alternative housing. certainly, i couldn't afford one of these fancy private assisted retirement homes. i've been to one of them to visit a friend of mine. she pays about $3500 a month for one room. i cannot afford that on my pension (dorothy, 83). my mom [hong, 90] is on the waiting list. well, it's been 10 years already since she registered. it's one of the chinese long-term care homes. […] oh, yes, it's common. they say it normally takes over 10 years! (lin, 64). these comments underline the lack of affordable alternative housing many older adults face. during our visit, we were also impressed by their efforts to control their home environment to live safely. all participants had at least one chronic health condition. however, their biggest challenges were mobility issues -especially difficulty in walking, falls, and the fear of falling. despite their use of mobility aids (e.g., cane, walker, wheelchair), many participants talked about their occasional falls. all had made some home adaptations by installing safety features (e.g., staircase railing, grab bar, special chair and non-slip mat for bathrooms). they were also using assistive devices. ten of 12 participants carried an emergency alert pendant or had installed an alert system with pull cord for their bathrooms. this was a lifesaver for some. valerie, 92, who has had multiple falls, related: i've used it twice. one time, they were able to get in through the kitchen window. the other time, i was doing christmas decorations when my daughter phoned, and when i turned, i fell. my daughter phoned a friend's husband to come, but before he arrived, i phoned the emergency alert and asked them if there was a particular way he should pick me up. they immediately sent somebody and got me on the chair. valerie's story suggested how unexpectedly and easily falls can happen at home, and how the assistive device helps in those instances. many participants were also using other technologies to help increase their sense of control and autonomy. half used a tablet or a computer for frequent communication with their families, reading news, and searching information. a participant with vision problems showed us a sight enhancement reading machine. one had a mobile chair lift for the staircase. the most advanced case of impairment was renelsa, who at 84 spent most of her day in bed due to her frailty, but she could still live alone in her one-bedroom apartment in community housing. her building had a security camera to screen visitors, and her apartment door could be opened with a remote control beside her bed. we had no idea about how limited her mobility was until she greeted us in her bedroom. participants in assisted living appreciated similar safety features in their units, and the railings in the hallways and elevators. in addition, mei lien, 68, explained how her residence gave her "peace of mind": "last year, in the middle of night, i had to call somebody, and they [staff] came up. i don't have family in canada, so at least you know somebody is there if you call". margaret, 84, who was recently widowed, reflected on her decision to move from her house to a seniorfriendly condo: the very last thing i wanted to do was move into this building… do i want to live here? no! but should i live here? absolutely! … if you think your health is going to be the same tomorrow as it is today, you are wrong. we all progress to some extent from day to day … i did not know the presence of a garbage disposal in the hallway was so convenient. so in the big picture, it was a very wise thing. in this way, each participant was negotiating their own physical and social conditions, and actively managing to control their home environment as best they could. the second theme involves our participants' distinctive shared character. although their life histories and current conditions varied, we were struck by their positive, spirited, and persevering attitudes. contrary to our expectation, participants rarely brought up their needs. we thus had to ask if there was anything to complain about. dorothy, 83, who had just recovered from a fall on ice, laughed and said: well, i think, oh, god, i ache, i ache, i ache, but i shouldn't complain, especially when i see other people… at least, i can still walk around, i can still look after myself, and do my own thing in my own house. so you know, i would say i'm fortunate. […] well, you have to make the choices yourself, don't you? you either sit there and wither away, or you get involved and do something. luisa, 78, mentioned that she had learned it from her role model: i am a contented person. i am not always looking for what i don't have. i learned that from my mother. she independently lived in her own apartment until 93, climbed stairs to the fourth floor, and always baked and cooked for visitors. you know, she never complained about her situation. she was fiercely independent. as these comments imply, many of our participants held to a similar principle in their lives. in fact, participants commonly described themselves as brave, independent women. their life stories were full of personal and historical events: the great depression, world war ii, immigration, marriage, divorce, separation, accident, the deaths of spouses, children, and friends, and their own health problems. every participant had an occupation at some point, and many repeatedly used the word "independent" to describe themselves. as hannah, 88, who had immigrated from germany with her husband after world war ii, put it: i was always this independent (laughter). i was married, and i was independent. i became a widow at the age of 42, and raised three children. when my husband got sick, i had a job [a lab aid in a hospital] and i took a year of absence to take care of him at home. but i needed the money, so i cleaned houses, took in other people's clothes. i wanted my children to have a better education. i never went on welfare, i worked and all my children went to university. if you came from a different country, you help yourself, you don't rely too much on the country. it's my job to look after the family. a former university professor, margaret, who was mourning her husband's death and managing her own health problems, described her efforts to be a strong role model for others at 84 years old: i am very strong-willed person. i was always a determined youngster. even as a girl, i was an independent child (laughter). even now, i just have to get really strong to be a good role model for women. i always try to be, because who is going to be the one to make me look and feel strong? me! you will only be strong if you work to be that way. […] i just live today, that's exactly how i think. i believe you stay the strongest person you can be each day you are alive. as these comments suggested, our participants' self-identity as strong independent women developed through various life experiences, sustains them in the face of the challenges of later life. nevertheless, we also learned that participants' "independent" lifestyles were supported by many other people in a mix of formal and informal care. due to our recruitment criteria, all participants had had an experience of publicly funded "formal" home care. however, at the time of our interview, only four were eligible for long-term home care, receiving 30 min to 1.5 h a day. for the other eight participants, publicly funded home care ended two to three months after a hospitalization. once this post-acute care was over, they were back on their own. the four participants who could afford it hired a paid housekeeper a few hours a week. two more, thanks to their retirement benefits, continued regular physiotherapist visits at home or attended weekly exercise classes through community agencies. compared to those living in regular houses or apartments, participants in assisted living had an advantage in the availability of and accessibility to long-term home support services right in their own buildings. however, some expressed hesitation to use additional support services due to their worry about the additional cost: "if you need the extra service, you have to pay. it depends if you or your family can afford it. so you just hope and pray you won't need more services" (mei lien, 68). like mei lien, many participants saw cost as a barrier to longer-term formal home care. as mentioned before, however, none explicitly advocated a more affordable publicly supported long-term home care system. in contrast, participants talked much more openly about informal care and support -their reliance on their family members, friends, and neighbors for regular help for transportation and household chores. ten out of 12 participants, regardless of residential type, had at least one close family member nearby. while most participants still managed to clean their homes, do laundry, and cook simple meals, carrying groceries and to taking public transportation were getting harder. family members were the primary source for a wide range of household chores. luisa, 78, described the support from her son's family: it helps me a lot that my son and daughter-in-law live here [in the same city]. i've been calling them to do things. he installed the railing on the basement stairs, because i've had three falls since last december. it just makes me feel more secure. and my daughter-inlaw takes me to a rheumatologist in another city, because i don't drive highways anymore. for participants whose family members lived far away, friends and neighbors were crucial sources of social support: "i have a good friend who takes me grocery shopping and to doctors' appointments" (hannah, 88); "when i had the cancer, i had radiation 28 times in december. every morning i told my friends, i cannot do it one more day, but i did thanks to them" (elizabeth, 92). as these comments suggest, most participants were grateful for the informal support and care provided by family members, friends and neighbors. clearly, these provided crucial instrumental and emotional support to all participants. overall, participants' narratives suggested an imbalance between formal and informal home care and support. even for participants receiving publicly funded long-term home care, that was not enough to live alone at home with disability and frailty, due to the limited time and tasks performed by the personal support workers (psws). for example, although psws help renelsa three times a day for a total of 1.5 h, it is her brother who brings over meals twice a week to store in her freezer. for hong (90), who speaks limited english, communication with the psw is challenging. as her daughter said, "the agency working in this building has no psw who speaks chinese. for showering, communication is very important. that's why i need to translate. otherwise, i could be preparing breakfast during that time" (lin, 64). participants in assisted living also reported regular informal support from their family members. katharine, 88, who no longer cooks for herself, mentioned: "i can have dinner at the dining hall downstairs, but my niece and nephew do weekly shopping for my breakfast and lunch." compared with participants living in houses, however, those in assisted living did not have to rely family and friends for daily personal care. overall, regardless of residential type, our participants' narratives suggest their independent life was unattainable without support from many others. the fourth theme involves the benefits of opportunities for continued social participation. despite noticeable physical discomfort, most participants kept trying to maintain the activities and the relationships that they valued, which were clearly an important part of their social identity. three participants living in houses were still earning a small income. many participants also kept volunteering in their communities. in particular, participants in assisted living had many opportunities within their own buildings. for example, tami, 65, a master of 3d origami, taught it to her fellow residents while volunteering at a nursing home once a week. as she explained: in 2010, when i got this problem [a rare and progressive degenerative disease], i started volunteering. the volunteer work makes me happy. sometimes, it's just sitting and talking to them [the residents in a nursing home]. but if i talk to them, they smile. they are losing their smile all day, so i want to make them smile. smile … like cheeks up. their smiles make me happy. like tami, many participants mentioned their joy at making themselves useful to others, despite, or possibly because of, their own mobility and health challenges. tami also appreciated the wheel-trans system that made her volunteering possible. most participants also stayed active in the groups to which they belong. elizabeth, 92, a former entrepreneur, described her monthly routine: "i go to church on sundays, probus club and torch club once a month…i also go to all sorts of classes". although elizabeth had no family members in canada, her long-term involvement in her local community had helped her develop a circle of good friends who she could rely on. renelsa, 84, a former nurse and devoted christian once nicknamed "the sister in the operating room", could no longer attend church, so three fellow congregants visited her twice a month: "on sunday, we have church right here in my apartment! i really look forward to when they come". many residents in assisted living had an even busier schedule of social, cultural, and physical activities. emily, 85, showed us her monthly calendar on which she had circled her activities. on some weekdays, her schedule is packed from 7:30 am to 3 pm! we also noticed a notable difference in the accessibility for exercise between those living in their own house and apartment and those in assisted living. most participants in assisted living continued to attend using their canes and walkers, while those living in their own houses stopped going to exercise classes in their communities due to a lack of transportation and coverage for long-term physiotherapy. participants' narratives make it clear that these opportunities for civic engagement and social and physical activities give them a routine to leave their "homes" to socialize, and enable them to keep playing a social role in their communities. moreover, older women mutually support each other in various ways by giving rides, bringing soups, etc. they not only receive support from others, they kept providing support to each other. overall, our study's findings illustrate how older women living alone with physical limitations can, with support from others, manage to maintain their independence in places where they feel "at home". all were achieving "residential normalcy" (golant, 2015) in "homes" that were "uniquely their individual domain" (kontos, 1998, p.286) , where they could feel comfort, autonomy, security, self-identity, and continuity of self (golant, 2015; stones & gullifer, 2016; wiles, leibing, guberman, reeve, & allen, 2012a) . their familiar belongings-what coleman and wiles's (2020) termed their "objects of meaning"-symbolically connected their past, present, and perhaps future selves. this also overlaps with the concept of "belonging". as wahl et al. (2012) noted, familiarity, routines, and emotional attachment developed over time help preserve identity and enable aging well in the right place. despite their physical discomfort, all were "fiercely independent", a phrase used by two participants (elizabeth, 92; louisa, 78) . as prescribed by aging in place policy, they strove to alter their home environment to live as independently and safely as possible, deploying the strategies and resources available and affordable in their contexts. they practiced problem-focused "assimilative coping", but many also used emotion-focused "accommodative coping" by accepting and being content with what they have (golant, 2015, p.102) . these conscious behaviors exhibit our participants' "competences" (lawton & nahemow, 1973) and "agency" (wahl et al., 2012) , another enabler in person-environment interactions. one unexpected finding is their emphasis on being strong-willed "independent women". this self-image, developed over their life course, provides a psychological resource to cope with challenges in later life. clearly, they are "resilient" people (golant, 2015, p.118) who are motivated and confident, with the physical capabilities, mental stamina, and flexibility to find appropriate solutions to the environmental obstacles they face. yet, based on their life stories, we suspect that their resilience is not an innate personality trait so much as an ability to "adapt well" learned and developed over time in relation to others and to their environments ( van kessel, 2013; wiles, wild, kerse, & allen, 2012b) . we found this learning process to be resilient operating even among very old and frail participants. this supports peace et al.'s (2011) finding that, while frailty and decline of personal competence are related, they are not synonymous. older adults can confront challenges by bringing their life experiences to their person-environmental interactions. despite their limited mobility, many stayed involved in social and volunteer activities, using their skills and sustaining and developing relationships. importantly, our participants did not passively receive care. they also actively provided it to others. this finding overlaps with the concepts of "vitality and agency in frailty" for preserving selfidentity and continued self-development in later life (bjornsdottir, 2018; latimer, 2012) . it also highlights the crucial role of opportunities for social participation, meaningful and reciprocal contribution, and relationship building to aging in place. a recent increase in innovative community-based participatory approaches to aging in place, such as the naturally occurred retirement community (norc), for example, includes this reciprocal exchange of support and care by creating resourceful community environments (greenfield, scharlach, lehning, & davitt, 2012; sixsmith et al., 2017) . nonetheless, our findings also suggest some disabling factors. the constant "balancing act" (golant, 2015, p.355) person-environment interactions in later life demands was difficult for some, especially for those with severe mobility limitations, multiple comorbidities, few close family members and friends, and low income. also, the quality of our participants' aging in place was influenced by local environments, including the availability of affordable home care services, physical activities, and safe and reliable public transportation (e.g., wheel-trans). most notably, our participants were facing the challenges of pain and balance: falling posed a real threat, as found in previous studies (e.g., bushnik et al., 2018) . nevertheless, for many participants -especially those living in houses and apartments without transportation and private home care insurance -regular exercise classes, physiotherapy, and fall prevention programs were neither affordable nor accessible. given the proven benefits of interventions for falls and fear of falling (e.g., whipple, hamel, & talley, 2018) , it is essential to develop strategies to make those programs more available. policies in aging, health, and social services should support greater collaboration between community-based formal and informal care (ryser & halseth, 2011) . in the current discourse surrounding aging in place, independent living tends to refer to an autonomous lifestyle achieved through the personal efforts of individuals. in reality, however, as our findings show, aging in place for older women with physical limitations inevitably requires a view of "independent living" which promotes reciprocity and interdependence between individuals and their communities, including both formal and informal supports. in other words, as golant (2015, p.356 ) advocated, we need to adopt an "it takes a village" perspective. nevertheless, consistent with previous studies (johnson et al., 2018; kadowaki, wister, & chappell, 2015) , publicly supported long-term home care -especially for maintenance and prevention purposes, such as home support services and physiotherapy -was still unavailable for many of our participants. our study adds further contextual evidence to canada's need for the publicly supported long-term home care system many have advocated over the past decade (canadian home care association, 2016; gilmour, 2018; kadowaki et al., 2015; special senate committee on aging, 2009; turcotte, 2014) . overall, the findings of our study support the notion of aging in the right place proposed by golant (2015) . they suggest that, despite their tireless individual efforts to be independent in a place of their own, older women can reach a point where the changing balance between personal competence and environmental pressure requires a new strategy to maintain self-identity, what peace et al. (2011) term "option recognition" (p.751). participants who could afford it or were eligible for public subsidy often moved into assisted living to regain control. given the lack of a universal long-term home care system in canada, moving to assisted living helps reduce the heavy burden placed on some older adults and their family members (ryser & halseth, 2011) . at the same time, our participants' narratives reaffirm that alternative senior residences -such as active adult communities, assisted living, and continuum care retirement communities -are not a readily available or affordable option for many middle-income older canadians (dalmer, 2019) . finally, the most unexpected finding in our study is the collective silence of older women, the so-called "shadow story" (de medeiros & rubinstein, 2015) , about their unmet need for more formal and structural support reported in previous studies (e.g., canadian home care association, 2016; gilmour, 2018; turcotte, 2014) . this may be partly because the interviewers were "others" (dorothy, 83), making it hard for participants to reveal their true feelings, and partly because respondents wanted to present themselves as role models for their interviewers, who were of their daughter's and granddaughter's generation. complaining and demanding that their needs be met contradicted their core principle of "being independent". finally, adopting the neoliberal rhetoric of being self-reliant and autonomous model citizens, older women may see their growing care need for daily activities as an individual matter that they should take care of themselves, rather than a structural issue connected to the long struggle over public policy. further study is required to clarify these points and investigate how a "sociological imagination," as coined by c. wright mills (1959) , might be used to collectively empower older women and inform public policies alike. this study has several limitations. due to our small number of selfselected participants who are resilient and have positive outlooks, our findings reflect more the experiences of older women who are successfully aging in the right place, despite their physical conditions. the voices of older adults who live with cognitive impairment, depression, and social isolation, or whose lack of resources make them more vulnerable, are missing. furthermore, the data was collected before the covid-19 pandemic, which has likely altered older women's perceptions and experiences. all these areas are important, and deserve further study. despite these limitations, our research provides a valuable window into experiences of aging in the right place of an understudied groupolder women living on their own with physical challenges in canada. no matter how fiercely and successfully independent older women try to be, framing aging in place as a matter of individual efforts alone is misguided. it is crucial that more structural supports and improved community-based care that is informed by recipients themselves become an integrated part of public policy. the shifting of public perceptions from aging in place to aging in the right place has the potential to foster subjectively-defined aging well among older adults with different needs and resources. we hope these findings will encourage further studies and the political will to make aging in the right place a real option for older adults in canada and far beyond. this study was funded by a grant from the japan society for the promotion of science (#15k13083). none. rehabilitation therapies for older clients of the ontario home care system: regional variation and client-level predictors of service provision holding on to life': an ethnographic study of living well at home in old age health reports. health-adjusted life ex seniors' housing report -ontario better home care in canada: a national action plan health care in canada, 2011: a focus on seniors and aging being with objects of meaning: cherished possessions and opportunities to maintain aging in place qualitative inquiry and research design: choosing among five approaches a logic of choice: problematizing the documentary reality of canadian aging in place policies narrative gerontology in research and practice shadow stories" in oral interviews: narrative care through careful listening thinking about your future? plan now to age in place -a checklist report on housing needs of seniors transitions to longterm and residential care among older canadians unmet home care needs in canada commentary: irrational exuberance for the aging in place of vulnerable low-income older homeowners the quest for residential normalcy by older adults: relocation but one pathway women's housing challenges in later life: the importance of a gender lens using ecological frameworks to advance a field of research, practice, and policy on aging-in-place initiatives a conceptual framework for examining the promise of the norc program and village models to promote aging in place senior women. women in canada: a gender-based statistical report. catalogue no.89-503-x. ottawa: statistics canada no place like home: a systematic review of home care for older adults in canada influence of home care on life satisfaction, loneliness, and perceived life stress resisting institutionalization: constructing old age and negotiating home home care and frail older people: relational extension and the art of dwelling ecology and the aging process utilization of formal and informal home care: how do older canadians' experiences vary by care arrangements social work and aging in place: a scoping review of the literature telling stories: the use of personal narratives in the social sciences and history qualitative research: a guide to design and implementation housing-related control beliefs and independence in activities of daily living in very old age option recognition' in later life: variations in ageing in place informal support networks of low-income senior women living alone: evidence from fort st ageing well in the right place: partnership working with older people. working with older people canada's aging population: seizing the opportunity aging and place: clarifying the discourse census in brief no. 4: living arrangements of seniors statistics canada catalogue no. 98-312-x2011003. ottawa, on: statistics canada the daily. canada's population estimates: age and sex income of individuals by age group, sex and income source, canada, provinces and selected census metropolitan areas at home it"s just so much easier to be yourself': older adults' perceptions of ageing in place living alone in canada. insights on canadian society canadians with unmet homecare needs the ability of older people to overcome adversity: a review of the resilience concept aging well and the environment: toward an integrative model and research agenda for the future fear of falling among community-dwelling older adults: a scoping review to identify effective evidence-based interventions the meaning of "aging in place" to older people resilience from the point of view of older people the sociological imagination we would like to send our heartfelt thanks to all participants in this study for generously sharing their life experiences and insights. our appreciation also goes to the organizations and their staff members, our colleagues and friends, who assisted in our recruitment, and ms. jessica wong and ms. ramesha ali for their assistance in data collection. we extend our acknowledgement to dr. beard and two anonymous reviewers for their encouraging and constructive feedback. key: cord-280449-7tfvmwyi authors: hoplock, lisa b.; lobchuk, michelle m.; lemoine, jocelyne title: perceptions of an evidence-based empathy mobile app in post-secondary education date: 2020-08-25 journal: educ inf technol (dordr) doi: 10.1007/s10639-020-10311-3 sha: doc_id: 280449 cord_uid: 7tfvmwyi cognitive empathy (also known as perspective-taking) is an important, teachable, skill. as part of a knowledge translation project, we identified a) interest in an evidence-based cognitive empathy mobile app and b) which faculties believe that cognitive empathy is important for their profession. students (n = 638) and instructors/professors (n = 38) completed a university-wide survey. participants in education, social work, and the health sciences were among those most interested in the app. the majority of participants said that they would prefer for the app to be free or less than $3 for students. most participants preferred a one-time payment option. across 17 faculties, all but one had 60% or more of its sampled members say that cognitive empathy is important for their profession. results illuminate perceptions of cognitive empathy instruction and technology. results also provide insight into issues to consider when developing and implementing an educational communication app. self-reflecting; hoplock and lobchuk 2019; vorauer 2013) , it has been linked to positive outcomes such as increased patient compliance and satisfaction within healthcare (kim et al. 2004) , engaging in prosocial behavior (davis 2015) , team effectiveness, and engaging in high quality communication (parker et al. 2008) . people vary in their ability to engage in cognitive empathy, but fortunately, it is a skill that can be taught (e.g., brunero et al. 2010; richardson et al. 2015; teding van berkhout and malouff 2016) . one way that cognitive empathy can be taught is by using technology (e.g., lobchuk et al. 2018) . the present research examines people's perceptions of a cognitive empathy-training mobile app as well as how perceptions of cognitive empathy's importance vary by profession. cognitive empathy is studied in a variety of fields, such as healthcare (e.g., blanch-hartigan and ruben 2013; lobchuk et al. 2016 lobchuk et al. , 2018 , psychology (e.g., marangoni et al. 1995; vorauer and sasaki 2014) , business (e.g., ku et al. 2015) , and law (e.g., bandes 2009 ). one frequently-used paradigm involves filming an interaction between two people, having the interaction members report what they were thinking and feeling throughout the interaction, having the interaction members guess what the other person was thinking and feeling throughout the interaction, and then providing an accuracy score (ickes 2001) . this accuracy score indicates how accurate a person is at inferring the thoughts and feelings of another. accuracy is associated with relationship satisfaction (sened et al. 2017; thomas and fletcher 2003) , skillfully providing social support (verhofstadt et al. 2016) , and accommodating during conflict (kilpatrick et al. 2003) . thus, accuracy is helpful for facilitating successful communication and relationships across contexts. people's perspective-taking ability improves when they are self-aware of personal values/emotions that can thwart empathy (lobchuk et al. 2012) ; receive instruction (lelorain et al. 2012 ) and feedback (noordman et al. 2012) , and self-evaluate with video-feedback (fukkink et al. 2011 ). the authors have been conducting iterative research on an intervention that takes these findings into consideration, incorporating ickes' (2001) paradigm and including perspective-taking instruction. however, currently, the intervention involves coming into a lab for the filming. to increase accessibility and cost-effectiveness, the intervention could be adapted as a mobile app for use within any setting, not just the classroom. most students world-wide own a smartphone (e.g., farley et al. 2015; nason et al. 2015; o'connor and andrews 2018; williamson and muckle 2018) . while mobile devices such as smartphones and tablets (crompton and burke 2018) are sometimes seen as a distraction in the classroom, they are increasingly being leveraged to facilitate learning (langmia and glass 2014; nguyen et al. 2015) . indeed, with classes being forced online due to covid-19, it is expected that instructors will incorporate technology into their courses more than ever before (bates 2020) . it is important that devices are used in a way that facilitates taking an active role in learning (norris et al. 2011) . when they are used in that way, mobile devices may improve student motivation and productivity (cotter et al. 2015) , confidence (koohestani et al. 2018) , and performance (dunleavy et al. 2019; hsueh et al. 2018) . for example, a recent metaanalysis of healthcare research on using mobile technology within education (mlearning) found that participants who experienced mlearning tended to have superior knowledge and skills than those who received traditional education (dunleavy et al. 2019) . thus, growing evidence supports the use of mlearning. we are interested in people's perceptions of using an app for teaching and practicing cognitive empathy. research findings do not always get translated into practice in fields like education, and it can take a long time for them to be implemented if they do (burkhardt and schoenfeld 2003) . we follow the canadian institutes of health research knowledge to action process (kta; government of canada 2016) framework to expedite the integration of our evidence-based intervention into students' learning activities. according to this framework, knowledge is created (e.g., through research) and then translated into application through an iterative cycle. knowledge creation includes inquiry, synthesis, and product-creation (government of canada 2016). we aim to move our research towards the product-creation phase and ensure that it becomes incorporated more quickly into practice. we currently conduct the intervention with students from a variety of healthcare disciplines (e.g., nursing, occupational therapy, kinesiology; (e.g., lobchuk et al. 2016 lobchuk et al. , 2018 . one version of the intervention has also included videoconferencing (hoplock and lobchuk 2019b ). yet, this intervention could be made more accessible if it were converted to mobile technology. many students and instructors/professors own mobile devices and use apps, making them the ideal population to assess the potential use of mobile learning for educational purposes in an academic setting. it is important to conduct market research with the population of interest (university students and instructors/tenure-track and tenured professors), so that we understand potential app users and the merit of creating the app before we start creating it. we want to ensure that what we create is meaningful to the people who will use it and that it will be used within communication skills curricula. to date, we have conducted intervention research with health professionals. however, it is possible that the potential intervention user-base is larger than just those in the health profession (e.g., law, education, or business). thus, we circulated a university-wide survey to students and instructors/professors to better understand who might be interested in the intervention and cognitive empathy. the purpose of the present research is to identify the target market, demand, and price point as well as to solicit student and instructor/professor perceptions of the empathy-training mobile app. we had the following research questions: this work may appeal to people who study empathy, education technology, marketing, and business. this research may also help people who want to create related apps. cognitive empathy is a valuable skill for successful interpersonal relationships (e.g., batson and ahmad 2009; davis 2009; davis 2015; galinsky et al. 2005 ) and so converting a successful intervention to be able to teach empathy accessibly is a worthy goal. after obtaining ethics approval, we conducted a survey to answer our research questions. in accordance with simmons et al. (2011 simmons et al. ( , 2012 , we report how we determined our sample size, all data exclusions, all experimental manipulations (there were none), and all study measures. our aim was to give all students and instructor/professors the opportunity to describe their opinions or attitudes toward our empathy application. a census sampling frame was determined to be most appropriate. this sampling frame aims to collect information from every eligible member of the population. our decision was not to exclude any student or instructor/professor at the university so as to boost our success in accruing a representative sample of students and faculty by taking a census sampling approach. because this work was exploratory, we did not conduct a formal power analysis. instead, we aimed to recruit at least 300 students (hao et al. 2017 ) and 100 instructors/professors (vrana 2018) or as many participants as we could before our stopping rule: complete data collection by the end of december, 2018 (approximately 1 month after data collection started). we chose this stopping rule due to time constraints. participation was restricted to students and instructors/professors over the age of 18. approximately 30,000 students and 1100 instructors/professors were emailed a survey link; 1081 people accessed the survey. data from 676 participants were retained (638 students; 38 instructors/professors) after exclusions (n = 13 did not provide consent; n = 391 did not fully complete the survey; one person provided nonsensical responses). most participants identified as white (66% students, 86% instructors/professors) and as women (68% students, 75% instructors/professors). the average ages of students and instructors/professors were 24.64 years (sd = 8.02) and 48.82 years (sd = 9.19) respectively. participants volunteered for an online study on "perceptions of an evidence-based empathy mobile app in post-secondary education." at the start of december 2018, they were emailed a study description and link. they were told that they would have until the end of the month to complete the study. a reminder was sent mid-way through the month. participants did not receive compensation. materials can be found on the open science framework: https://osf.io/bh9 su/?view_only=0ff44fe143914e0088c1f5d54ac7f8c6. the majority of questionnaire items were author-created and inspired by the literature (e.g., alwraikat and tokhaim 2014; sevillano-garcia and vazquez-cano 2015; vrana 2018) . we obtained suitability and coverage feedback on our survey from experts in technology development at the university's technology transfer office. the overall structure of the questionnaire was the same for students and instructors/professors, however the content of the questions varied. students completed questions regarding using the app as part of their education. instructors/professors completed questions regarding using the app as a teaching resource as well as for personal use. after providing informed consent, participants were first presented with a description of the app's purpose and how it would work. they saw two wireframes to give them a sense of the app idea and what the app might look like. next, they were asked their perceptions of the app. students rated their agreement on four statements (1 = strongly disagree, 7 = strongly agree), providing their perceptions of the app as being applicable to their profession, their perceptions of the app helping them to meet their needs, their liking using mobile learning as part of their educational curriculum, and their confidence in using mobile technology to achieve their learning goals. instructors/professors were asked to rate their agreement with six similar statements using the same scale. four of the statements related to using the app for teaching or professional work, one related to their perceptions of using mobile technology as an education tool, and one related to their confidence in using mobile technology to achieve their teaching goals. participants then indicated their interest in the app, with faculty indicating both their interest in the app as a teaching tool (1 item) and their personal interest in the app (1 item; 1 = very disinterested, 7 = very interested). using an open-ended question format, participants provided their reaction to the app (adapted to an open-ended question format from a 5-pt likert scale from surveymonkey n.d.). they then indicated how likely they would be to consider buying the app (1 = extremely unlikely, 7 = extremely likely; adapted from a 5-pt scale; surveymonkey n.d.). those who selected 1 or 2 on the scale were asked an open-ended question regarding why they were unlikely to consider buying the app. faculty were also asked how likely they would be to recommend that student buy the app (1 = extremely unlikely, 7 = extremely likely; adapted from a 10-pt scale and to this context; surveymonkey n.d.). those who selected 1 or 2 on the scale were asked an open-ended question regarding why they were unlikely to consider recommending buying the app. to better understand price point and pricing strategies, we asked participants to check all that apply when considering what one-time price they would feel comfortable paying for the app ($0.00; $0.01-$0.99; $1.00-$2.99; $3.00-$5.99; over $5.99), what payment type they would prefer (subscription (i.e., several smaller payments); one-time payment (i.e., one larger payment)), and what payment version they would prefer (consumers may choose between a basic version of the in your shoes mobile app that is free and a version that has extra features and a cost; consumers use a free trial of the in your shoes mobile app with extra features and payment is required later). students responded while imagining that the app was required in a course and then responded imagining that the app was not required in a course. instructors/professors were asked what they would feel comfortable asking students to pay if the app was required in a course, and then if it was not required. instructors/ professors were also asked what they themselves would pay if using the app for personal use. participants next completed demographics questions asking about gender, age, ethnicity, income (statistics canada 2020), smartphone or tablet ownership and use (chen and denoyelles 2013), device brand (adapted from chen and denoyelles 2013 to ask about what brand they primarily use instead of what device they own), hours spent on their phone or tablet for things related to work/school (chen and denoyelles 2013), whether they use an app for coursework (adapted from chen and denoyelles 2013 to ask whether they have used an app instead of how often), their faculty, college, department, and class format (in-person/in-class; online/distance; mix of in-class and online courses). students were asked about their program year, degree, and student status. instructors/ professors were asked their academic rank and teaching experience (the latter was adapted to include more options for those with fewer years of experience; alwraikat and tokhaim 2014). we also wanted to know if participants' respective programs had at least one course that focuses on interpersonal communication (yes, no, unsure) . those who answered "no" or "unsure" were asked if interpersonal communication was incorporated into their curriculum to some degree. finally, participants rated whether cognitive empathy was important for their profession (1 = not at all, 7 = extremely). we employed a descriptive, cross-sectional, online survey with participants. with all students and instructor/professors at the university having been invited to participate, we had the opportunity to 'drill down' and conduct exploratory analyses of linkages between student and instructor/professor characteristics and their opinions or attitudes toward the empathy application. descriptive statistics (medians, means, standard deviations, frequency counts, and percentages) were used to describe the sample of students and instructor/professors, as well as address research questions 1 to 3. we ran the responses to the open-ended questions through a sentiment analyzer and a word cloud generator located on danielsoper.com to get an objective sense of participants' sentiment towards the product. sentiment analyzers use "computational linguistics and text mining to automatically" determine the overall degree of negativity (â��100), neutrality (0), or positivity (100) in the text (soper n.d.) . word cloud generators analyze text to determine whether certain words are used more frequently. a strength of these two approaches is that it analyzes the results impartially and, thus, will help validate results found using our other methods. a limitation of these approaches is that they examine the overall text, without nuance. we also analyzed the responses to the open-ended questions using content analysis (see online supplemental materials for additional details; lincoln and guba 1985; patton 2002) . credibility was established by recruiting participants from the target population (elo et al. 2014) . dependability and confirmability were met with an audit trail documenting coding decisions and template development (e.g., saldana 2009 ). confirmability also occurred through independent coding and analysis and by an iterative feedback process until consensus was reached (graneheim and lundman 2004) . we also used participants' own words for codes and themes when possible to ensure that we stayed close to the data (levitt et al. 2018 ). there are 17 faculties at the university. at least one student from every faculty participated. instructors/professors from 10 faculties participated. therefore, we obtained diversity in the faculties that participated. over 90% of participants owned and used a smartphone or tablet, and most participants (61.3% students; 83.3% instructors/ professors) used apple products. for students, 44% have used a mobile app required or suggested by their instructor for course work. for instructors/professors, 57% have required or suggested to students to use a mobile app for course work. most participants preferred the app to be free (41% of students; 34% of instructors/professors) or less than $3 for students (56% of students; 34.2% of instructors/professors). participants also preferred a one-time payment option (85% of students; 66% of instructors/professors) as well as the ability to choose between a basic version of the app that is free and a version that has extra features and cost (74% of students; 63% of instructors/professors; see online supplemental materials for other participant details). addressing research question 1 (who would want to use this app), 44% of students and 53% of instructors/professors said that their program features at least one course that focuses on interpersonal communication. of those who said that their program did not feature an interpersonal communication course or that they were not sure if it did, 33% of students and 53% of instructors/professors said that interpersonal communication is incorporated into the curriculum to some degree. faculties from where most professors and instructors indicated that they had an interpersonal communication course in their program included business, education, health sciences, law, and social work. instructors/professors from the arts, education, health sciences, and law were among those most interested in using the app as a teaching tool (table 1) . instructor/professors from business; education; environment, earth, and resources; and law were interested in using the app for personal use (table 2 ). students in agriculture; art (e.g., fine art); arts (e.g., sociology); education; environment, earth, and resources; health sciences; music; science; social work; extended education; and university 1 (a faculty for those just starting at the university) were interested in the app (table 2) . thus, these faculties may be a good target for uptake of the app. when analyzing participants' reactions to the app, one theme that emerged, target or use case, involved commenting on the target people or use case (i.e., when or in what contexts someone might use it) for the app. this theme's categories included that the participant thought the app was not relevant to them; the participant commented on who the target audience might be; and the participant commented on potential use cases for the app (table 3) . for example, one participant (woman, instructor/professor, faculty of agricultural and food sciences) wrote, "looks great for areas where you need to communicate with a patient/client on more than one level. not so much in my area." another (man, student, faculty of health sciences) wrote, "the app sounds fun and with right pricing could be helpful to new international students." these responses help narrow the target market. addressing research question 2 (what people from the target population think of the app idea), sentiment analysis and word cloud generator results of the open-ended questions indicated that responses were generally neutral to negative. students' responses to "what is your reaction to the in your shoes mobile app" were neutral (0.3; possible range = â��100 to 100). the word cloud indicated that responses were focused ratings were made on a 7-pt scale with higher numbers indicating greater interest in the app around empathy, apps, and the perception that the idea is interesting (see online supplemental materials for the word clouds). instructor/professor responses were somewhat negative (â��42.4). their word cloud was somewhat similar to that of the students, but was also focused on students, teaching, and learning. diving deeper, when analyzing participants' reactions to the app, two additional themes emerged: participants described practical issues with the app, which might affect uptake and participants commented on the concept idea (table 3 ). the first theme's categories included barriers to empathy and barriers relating to the intervention procedure. for example, one participant (man, student, university 1 faculty) wrote, "seems like a great idea but would be a little weird to find a partner to record conversations and get them to tag their thoughts and feelings." these responses help identify potential concerns and factors to watch out for when creating the app; for example, finding the right dialogue partner and drawing on a relevant context to engage in a meaningful dialogue. the second theme had four categories: 1) positive reactions to the app idea (e.g., favourable evaluation of the app, willingness to try the app, and visualizing positive outcomes as a result of using the app); negative reactions to the app idea (e.g., unfavourable evaluation of the app; doubts in teaching empathy with an app; negative comments about empathy training in general; and comments about the app not practical issues with the app: participant describes barriers to using the app, which might affect uptake barriers to empathy: participant describes barriers that relate to empathy "it seems impractical -a lot of people would probably be very uncomfortable with the exercise described above and would not want to put in the time to tag a recording of their conversation." (woman, student, faculty of arts) procedure: participant describes barriers that relate to the intervention protocol "the instructions are a little complicated, which i believe will prevent some students from using it unless they really want to put in effort. it would be better if scenerios (sic) were supplied in addition to this feature so it didn't require two people to use." (man, student, university 1) these responses indicate varying support for the app idea and help clarify the sentiment analysis and word cloud results. participants who indicated that they would be unlikely to buy the app (i.e., they selected 1 or 2 on the question "how likely are you to consider buying the app") were asked about their response. students were understandably somewhat negative given the nature of the question (â��18.3). their word cloud indicated that responses focused on money, apps, and the word "don't." (e.g., "i don't buy apps"). instructors/professors' responses were unexpectedly positive (99.1). 2 the associated word cloud focused on empathy and technology needing to add value to the course. three themes emerged from qualitative analyses that help us to understand the disinterest in buying the app: 1) responses indicating that participants did not think they fit the target market; 2) responses about money or purchasing apps in general; and 3) responses about the app itself (table 4 ). like the target or use case theme for who would use the app, the first theme's categories included that the app is not relevant or that they lack interest in it. for example, one participant (woman, instructor/professor, faculty of social work) wrote, "i have taught interpersonal communication skills for approximately 25 yearsnot necessary" the second theme's categories included rarely or never spending money on apps; preferring a free app or a free alternative to the app; and that the app would not be a priority purchase (not worth the money). for example, one participant (agender, student, faculty of arts) wrote, "i don't buy apps." another (woman, student, school of business) wrote, "i would only get the app if it had a free trial period to try it out." the third theme's categories related to perceptions of the app's effectiveness and the app's protocol (e.g., the app is impractical, privacy concerns, and confusion about the app's use case or procedure). for example, one participant (man, student, faculty of engineering) wrote, "low chance of repeated use, requires time commitment and analysis." together, these responses provide additional insight into potential concerns, factors to consider when creating the app, and the target market (e.g., offer a free trial, ensure reliable security, promote broad applicability). 2 it is possible that negation within the responses affects scoring as all responses except one included the word "not." thus, responses like "not necessary" may have been interpreted positively. according to the site, "this tool produces an overall sentiment score. although various passages within a sample of text may be particularly positive or negative, the sentiment score produced by this tool considers all of the text in the sampleâ�¦ research shows that in about 20% of all cases human beings will disagree about the sentiment of written text." (https://www.danielsoper.com/sentimentanalysis/default.aspx) faculty who indicated that they would be unlikely to recommend buying the app (i.e., they selected 1 or 2 on the question "how likely are you to consider recommending buying the app") were asked about their response and (as would be expected given the nature of the question) responses were quite negative (â��69.1). the word cloud highlighted a focus on the classroom, skill development, empathy, and being unconvinced. three themes emerged from qualitative analyses: 1) responses indicating that the app is not relevant to the participant or their field (mirroring responses to being unlikely to buy the app); 2) responses indicating skepticism that empathy can be taught with an app (i.e., they are not convinced); and 3) responses about money or purchasing apps (table 5) . for example, one participant (did not report gender, instructor/ not relevant/no need: participant states that the app is not relevant to them or their field or states disbelief regarding the need for an app to teach empathy (e.g., they say that they are already empathetic) "not appropriate to my area of teaching" (man, instructor/professor, faculty of environment, earth, and resources) lack of interest: participant lacks interest "there would never be a time when i would want to use this. the only way i would ever use it is if were part of a leadership training thing." (man, student, faculty of science) about money: participant makes a comment related to money or purchasing apps rarely or never spend money on apps: participant says that they do not like purchasing apps or that they do so rarely "i never pay for apps" (woman, student, faculty of agriculture and food sciences) free app or free alternative: participant indicates that they would download the app if it were free, otherwise they would prefer a free alternative professor, faculty of arts) wrote, "i don't think they would use it and i'm not sure that i feel that an app is the best approach to learning empathy, so i'm not convinced on its utility." while another (did not report gender, instructor/professor, did not report faculty) wrote, "students have better things to spend their money on, however small the amount." together, these responses provide additional insight into the target market and instructor perceptions of using technology to teach empathy. addressing research question 3 (which professions believe that cognitive empathy is important to their profession), 81% of students and 83% of instructors/professors said that cognitive empathy is important for their profession. most participants (60% or higher) from all 17 faculties except one (school of agriculture) thought that cognitive empathy was important for their profession (table 6 ). the present research helps us progress towards the product-creation phase within the kta framework to facilitate uptake of an evidence-based intervention more quickly into the classroom. like other research (farley et al. 2015; nason et al. 2015 ; o'connor and andrews 2018; williamson and muckle 2018) over 90% of participants owned and used a smartphone or tablet. some, but not the majority, of instructors/professors were asking students to use mobile apps for their course work (see also ariel and elishar-malka 2019) . this amount is likely to increase spurred by the covid-19 pandemic. we also found that when considering the empathy-based app for class use, qualitative results echoed those found in previous research: participants mentioned usefulness, money, the ability to use a trial version, and enjoyment (kim et al. 2016 ). these variables are important because they predict intention to purchase an app (kim et al. 2016 ). together, results indicate a potentially large market for apps within higher education and that apps might be successful if perceived as useful, enjoyable, and triable. these findings are timely because there is a worldwide movement in education toward remote learning and using technology to deliver content (e.g., bates 2020). our research adds to the literature by illuminating perceptions of app cost within education. the majority of participants said that they would prefer for the app to be free or less than $3 for students. most participants preferred a one-time payment option. they also preferred the ability to choose between a basic version of the app that is free and a version that has extra features and a cost over a free trial and later payment. qualitative responses indicated that some participants just do not purchase apps. additionally, student participants described being stretched for resources and unable to spend money on apps. apps tend to be free and people often prefer free alternatives to having to pay (hsu and lin 2015) . thus, making the app free may increase uptake. app developers and marketers should consider making apps free for students and passing the cost on to institutions, when possible (see table 7 for all recommendations). doing so would allow a greater number and diversity of people to learn about concepts such as empathy. apps provide opportunities to advance changes in how content is being taught in and outside of the classroom. currently, when instructors and researchers want to use paradigms like ickes' (2001) , they often require students to come into a lab (e.g., lobchuk et al. 2016) . this makes participating unfeasible and costly for many. indeed, the present research indicates that cost is top of mind for students. the ubiquity of (lobchuk et al. 2012) ; receive instruction (lelorain et al. 2012 ) and feedback (noordman et al. 2012) ; and self-evaluate with video-feedback (fukkink et al. 2011 ) so that their perspective-taking ability improves. the present research indicates that people recognize the value that a cognitive empathy app can hold and how it can be used. the present research also highlights concerns that people have about using apps for empathy instruction. we found that some people are wary of using their personal devices for recording conversations and being vulnerable. these people might benefit from coming into the lab and participating in a safe experience before using the app, as well as from receiving tips on finding a dialogue partner and drawing on relevant context to engage in a meaningful dialogue. testing to ensure app security and communicating this security to users will also be important as will be ensuring a seamless experience and reducing procedural barriers via usability testing. additionally, our research finds that some people might need to be convinced of the benefits of using technology to teach empathy skills. developing a compelling marketing strategy that demonstrates how mobile devices can improve confidence (koohestani et al. 2018) and performance (dunleavy et al. 2019) , and cites evidence of the intervention's effectiveness might be beneficial here. the present research indicates that many people recognize the importance of cognitive empathy for interpersonal relationships and for their profession. convincing them that it can be taught with technology would ensure that more people get the instruction that they need. consistent with previous research (keyworth et al. 2013) , students want communication skills training. while previous research has studied cognitive empathy within a variety of fields (e.g., teding van berkhout and malouff 2016), the present research indicates that more fields are interested in it than likely previously thought. participants were interested in the app idea, with those in education, social work, and health sciences among the most interested. even participants in the physical sciences were interested and believed that cognitive empathy is important to their profession despite other research finding that being low in cognitive empathy predicts enrollment in the table 7 key recommendations to develop a mobile empathy app recommendations 1. make the app free or for a minimal cost to students and pass the cost to institutions, when possible 2. make the app a one-time payment for students 3. prioritize targeting people in the fields of business, education, health sciences, and law 4. empathize the benefits of dialoguing, self-reflection, and actively taking another person's perspective in marketing communications 5. provide tips on how to find a dialogue partner and draw on relevant context to engage in meaningful dialogue 6. engage in testing to ensure app security and communicate this security to users 7. conduct usability testing to ensure a seamless user experience and reduce procedural barriers 8. develop a compelling marketing strategy that highlights benefits gained across a variety of disciplines as indicated from previous research. developing concrete examples of when the app could be used and including testimonials would be helpful physical sciences (thomson et al. 2015) . perhaps they are aware of being low and want to improve their perspective-taking skills because they believe it is important for their profession. future research should investigate this further. the confusion and questions about the app protocol as well as the varying sentiment about the app indicates that more research is needed. future research will iterate app descriptions and wireframes to increase clarity and value of the app. scenarios where the app might be used will be guided by research and used in marketing so that the value of the app (e.g., trust-building; blatt et al. 2010 ) is evident to a wider range of people. one reason why increasing perceived value will be important is because it predicts app purchase intentions (hsu and lin 2015) . while the present research was a necessary first step into assessing perceptions of the concept idea, future research will also indicate how perceptions of the app and the idea of using technology to teach cognitive empathy changes as people start interacting with app prototypes. one limitation to this study is participant self-selection bias: the people who opted to participate in a study about empathy may have been more interested in this topic than others. this is evident, for example, in the number of instructors/professors who indicated that they taught courses having to do with interpersonal communication (53%), as well as the greater participation from people who participated in certain fields (i.e., health sciences, education). while we received student participation from every faculty area, this participation was not equal and there was less representation among instructors/professors. it is possible that we would have received a wider variety of responses had participants not known the app's topic (empathy) prior to starting the study. stating that the study focused on an instructional app or an app on communication skills (without mentioning empathy) might have increased the variability. generalizability is also limited because the sample was restricted to one canadian university. future pre-registered research examining perceptions of empathy's importance across disciplines should include a greater number of participants from diverse areas and could examine interest in an empathy app with a non-student population. for example, corporations may have more resources and be more interested in furthering the empathy of their employees than those within educational institutions. additionally, the survey was accessible during a busy month (december), thus people may have been more likely to participate had it occurred in a different month. moreover, the survey contained some adapted and investigator-developed questions that would benefit from additional validation. future research could conduct cognitive interviews to ensure that questions are being interpreted as they were written. despite these limitations, this research has a number of strengths, including the use of multiple methods and analysis techniques (morse 2015) . our methods allowed us to identify potential barriers to uptake, which is a step in the kta framework (graham et al. 2006) . potential user feedback spotlighted critical features to incorporate in an empathy app that is designed to foster targeted, meaningful, and efficient learning which can be differentiated based on discipline or profession. additionally, to our knowledge, this is the first study that has examined perceptions of the importance of cognitive empathy across a broad range of fields/professions. our finding that participants in a variety of fields/professions find cognitive empathy important will be of interest to people studying empathy, marketing, and education. taking the perspective of another and understanding where they are coming from is an essential skill for many professions. thus, being able to teach cognitive empathy effectively and accessibly is an important goal for instructors. as impacted by the covid-19 pandemic, efforts in restructuring how we teach in basic and continuing education are reflective of increasing reliance on technology-based learning. not everyone is enthusiastic about using technology in empathy education. some people are concerned that technology impedes empathy and learning by, for example, acting as a barrier between people. however, we believe that, done correctly, technology can instead act as a bridge. availability of data and material consent was not provided to share non-aggregated data. materials and word clouds are available on the open science framework: https://osf.io/bh9su/?view_only=0ff44fe143914 e0088c1f5d54ac7f8c6 funding information this research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors, nor has the app development received any funding to date. conflicts of interest/competing interests the results of the present research are being used to guide development of an evidence-based empathy app that the first two authors are creating. code availability not applicable. exploring the potential of mobile learning use among faculty members learning in the smartphone era: viewpoints and perceptions on both sides of the lectern. education and information technologies empathetic judging and the rule of law online enrolments after covid-19: some predictions for canada training clinicians to accurately perceive their patients: current state and future directions does perspective-taking 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students' perception of technology use in nursing education publisher's note springer nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations key: cord-332735-vfnbs2jn authors: rebmann, terri; wagner, william title: infection preventionists' experience during the first months of the 2009 novel h1n1 influenza a pandemic date: 2009-12-31 journal: american journal of infection control doi: 10.1016/j.ajic.2009.09.003 sha: doc_id: 332735 cord_uid: vfnbs2jn background a novel strain of influenza a (h1n1) was identified in april 2009 and developed into a pandemic by june 2009. this rapid and unexpected event had enormous implications for infection preventionists (ip) internationally. lessons learned from this event should guide future pandemic planning efforts. methods focus groups were conducted at the association for professionals in infection control and epidemiology, inc, (apic) 2009 conference to evaluate ips' experience with the novel h1n1 influenza pandemic and assess their perceived needs related to novel h1n1 topics and products required for future education and reference materials. results forty ips (37 from the united states and 3 international) participated in the focus groups. needed reference materials identified by attendees included infection prevention guidance for nonacute care settings; occupational health polices; and brief, multilanguage patient/family educational materials. educational topics on which ips need to be trained include isolation precautions/personal protective equipment recommendations for novel h1n1 patients, coordination between hospitals and community response agencies, and surge management. the rapidly changing and conflicting recommendations related to patient management made responding to this event challenging. ips require synthesized infection prevention guidelines developed in a concise, real-time format. conclusion ips must continue to partner with public health and other response agencies to address gaps in pandemic planning. infection preventionists' experience during the first months of the 2009 novel h1n1 influenza a pandemic a novel strain of influenza a (h1n1) was identified in late april 2009. within a single week, the world health organization (who) raised the pandemic phase from 3 to 5. the who pandemic phase 5 indicates that there is sustained human-to-human transmission of a pathogen in at least 2 countries and that a pandemic is likely imminent. 1 the centers for disease control and prevention (cdc) reported the first case of laboratory-confirmed novel h1n1 in the united states on april 15, 2009; a second case was reported 2 days later. 2 on april 22, the cdc activated its emergency operations center in response to the novel h1n1 outbreak; 4 days later, on april 26th, the cdc declared a public health emergency. 2 early cases were identified in texas and california, but the outbreak soon spread widely across the united states. by may 3, 2009 , the cdc deployed 25% of the strategic national stockpile to aid states in responding to this event. on june 11, 2009, the novel h1n1 outbreak was officially declared a pandemic by the who. 3 infection preventionists (ip) were on the frontlines during the early phase of the novel h1n1 outbreak, helping health care agencies develop policies and procedures to respond to this rapidly evolving event. the surge of infected individuals and ''worried well'' taxed hospitals and health care agencies around the world. prior to being declared a pandemic, the novel h1n1 outbreak grew exponentially in the weeks prior to the association for professionals in infection control and epidemiology, inc, (apic) 2009 annual educational conference and international meeting. this unexpected outbreak had enormous implications for ips internationally because infection prevention guidance related to novel h1n1 patient management, such as recommendations on isolation and personal protective equipment (ppe) usage, came out sporadically from various organizations, including the who and cdc and health departments across the united states. the ips who responded to this event in the early months of the outbreak had unique experiences that may provide lessons learned for other ips and should guide future pandemic planning efforts. the purposes of this study were to evaluate ips' experience with the novel h1n1 influenza pandemic and assess their perceived needs related to novel h1n1 topics and products required for future education and reference materials. the aims are to understand better the novel h1n1 pandemic and develop educational and planning/reference materials to aid in this and future infectious disease outbreaks. this project was conducted to support apic's goal of providing timely information relevant to novel h1n1 and to complement the work of apic's emergency preparedness committee. the authors developed the questions for this study. all members of apic who were registered for the apic 2009 annual educational conference and international meeting were invited to participate in the focus groups, regardless of size or functionality of institution or work location (within or outside the united states). the only inclusion criteria was being involved in the direct response to the 2009 novel h1n1 flu pandemic, defined as individuals who work in a hospital, health care, or public health agency that has handled/ managed at least 1 confirmed positive case of novel influenza a h1n1 in 2009. the authors recruited potential participants via e-mail. one focus group met each day in a meeting room located in the conference center site on june 7 and 8, 2009. snacks were provided to the participants during the focus groups. the nominal group method was used to elicit information on the topics of interest. 4 the focus group method (ie, opening-ended questions) was used to elicit details from participants' experience with the novel h1n1 influenza pandemic. 5 participants were informed that information collected would remain anonymous and that all responses were voluntary. focus group sessions were audiotaped, and the digital recordings were transcribed verbatim. content analysis included identifying, coding, and categorizing participants' response to the questions of interest. in addition, major themes that emerged were identified and categorized. subjects' demographic data were obtained for descriptive statistics. in addition, participants were asked to complete an 11-item survey containing items related to the novel h1n1 flu pandemic, such as hospital or agency protocols for worker protection, isolation, and ppe usage during the event. the institutional review board of saint louis university approved this study. apic funded the costs of the food and meeting location for the focus groups; saint louis university covered the costs of data transcription. quotations that characterize the major themes are reported. the words enclosed in brackets of the quotations are used to explain the respondents' quotes and are not the participants' words. all 1173 individuals registered for the 2009 annual educational conference and international meeting were contacted. forty participants took part in the 3 focus groups; the first focus group had 13 participants, the second had 17, and the third had 10. most focus group participants (93%, n 5 37) reported that they resided in the united states, spanning 21 states; 3 participants were from facilities outside the united states (australia, the united kingdom, and canada). most attendees worked in a hospital (73%, n 5 29), public health agency (13%, n 5 5), home health (10%, n 5 4), or ambulatory care setting (10%, n 5 4). the facility bed size ranged from 29 (a small, rural facility) to 17,000 (a large, international multiagency health care system). approximately half of the attendees worked in an urban area (53%, n 5 21); only 15% (n 5 6) were from a rural area. the majority of attendees was female (90%, n 5 36) and aged 50 years or older (70%, n 5 28). approximately half had a master's degree or more education (58%, n 5 23). twentyseven participants (68%) were certified in infection control. a full description of the participants' demographic characteristics is reported in table 1 . the participants identified many types of reference materials and education topics on which the participants believed ips need to be trained for future novel h1n1 or other pandemics. the reference materials/ products that received the most votes during the nominal group method portion of the focus groups are outlined in table 2 . the education topics that received the most votes during the nominal group method portion of the focus groups are outlined in table 3 . in addition, a number of themes emerged from the focus groups related to infection prevention emergency management issues encountered during the novel h1n1 influenza pandemic in spring 2009. one of the most frequently cited topics of importance to focus group participants was the lack of infection prevention guidance for alternate care sites and nonacute care settings such as physician offices, ambulatory care clinics, long-term care, nursing homes, and others. as one participant noted, ''all the information that came out was basically for schools or acute care.'' other participants stated that it was difficult to know how to manage novel h1n1 patients in this setting without guidance: one specific occupational health issue that focus group participants felt needs to be addressed is how to manage or prevent ill health care providers coming to work sick. as one participant stated, ''as much as you tell [health care workers] not to come to work sick, they still come.. we cannot allow employees to work sick, even with seasonal flu.'' money may be one potential reason that employees may work when sick. as one participant explained it, ''sometimes people will say, ôi can't afford not to work.õ '' another focus group participant agreed and added, ''it's hard to keep people off work when they are sick.'' focus group participants indicated that more administrative support and better human resource policies are needed related to furloughing staff and sick leave practices during pandemics. as one participant explained it,''we need [administrator's] support in saying that, when people are exhibiting symptoms, then they can't work in patient care.'' another participant agreed and added, ''of course the hospitals don't want to hear that you're not going to let the staff work.'' one focus group member stated that her human resource department was hesitant to furlough employees due to novel h1n1 because it would cost the hospital money. she was told by human resources, ' compensation] would not cover occupational exposures to [novel h1n1] because it's also out in the community.'' there was also some confusion about and hesitancy to enforce the cdc-recommended 7-day furlough period for staff infected with novel h1n1. as one participant stated,''we had more people who wanted to come back sooner than 7 days.'' occupational health issues were present in the community, as well. companies were hesitant to allow employees to return to work without some reassurance from the medical community that the employee was no longer contagious. as one participant explained, ''we had employers calling up the emergency departments and saying, ôi want this person tested, and they need to have a negative before we're going to allow them to come back to work.õ '' this created a lot of extra and unnecessary work for hospitals and health care agencies. one issue that participants found particularly challenging was the difficulty in maintaining staff compliance and trust in the face of changing and conflicting practice recommendations/standards. the participants were asked which sources they used to obtain clinical information and infection prevention guidance about novel h1n1 during the spring of 2009. all the participants reported that they obtained information about novel h1n1 from the cdc (100%, n 5 40); other frequently cited sources of h1n1 information included state health departments (83%, n 5 33), the who (75%, n 5 30), and apic (70%, n 5 28). focus group participants indicated that novel h1n1 clinical information and practice recommendations changed rapidly in the spring of 2009. as one participant noted, ''the case definition changed like 3 times during the course of the event for us.'' these rapid changes made it difficult for focus group participants to stay abreast of the latest recommendations. as one focus group member stated, ''the rules change so often, it's hard to keep up.'' another agreed and added, ''from 8 o'clock in the morning until 4 o'clock, [the recommendations were] totally different.'' not only were the recommendations changing rapidly, but many of the response agencies and professional organizations distributed conflicting guidelines. many focus group participants had a difficult time trying to interpret the inconsistent guidance from various agencies. as one participant explained: ''our biggest problem was that [these conflicting guidelines are] very difficult to interpret, especially when we go from cdc to state to local health departments. so we're trying to coordinate these efforts, and it's a constantly moving target.'' table 2 . reference materials needed for current and future pandemics topics that require development into quick reference materials ranked by order of importance* infection prevention guidance for nonacute care settings (ambulatory care, home health, physician offices, and others) infection prevention guidance related to occupational health issues evidence-based information for physician education patient and family educational materials that are brief (eg, 1-page fact sheet) and available in multiple languages patient management materials that are brief (eg, patient placement/isolation, ppe use, and others) isolation precautions materials that are brief and simple: electronic format preferred communication procedures when supplies run out infection prevention guidance for pediatric facilities resource management tool for supply allocation during a variety of events screening tools and forms that are simple to use algorithm/check list outlining steps of an outbreak investigation *order of importance determined by the nominal group method. one focus group member stated that she found it works best if you let staff know up front that the information and recommendations will be changing rapidly. as she explained,''i say to everybody, ôthis is fluid, this is going to change every day, so don't expect what i say today [to be] what i say tomorrow; expect this to be changing.õ '' one focus group participant indicated that the rapid changes in recommended practice did not pose a problem at her facility. as she explained, ''our staff was great. they just said, ôwhat is [the recommended practice] today? just tell me what it is.õ '' however, this facility seemed to be the exception. the general consensus from focus group participants was that the rapidly changing and conflicting recommendations caused confusion among health care professionals. as one focus group participant noted, ''we [ips] understand why these [practice recommendations change], but i'm not always sure that our staff do.'' the focus group participants indicated that this confusion caused many health care providers to question the credibility of the ips. as one participant explained: ''it's very disconcerting for ips to have to constantly put out different messages. you are constantly sending out different messages to your staff, and, after awhile, they say, ôoh, they don't know what they're talking about.õ it's very difficult [to maintain] credibility for your department.'' another participant agreed and added: ''i think the difficulty was getting the staff to [trust you]. because, you know, here you started out with [one recommendation], and then you're telling them that now [it's changed], and i think that was really hard for staff. i think they're still having a hard time trusting that we're telling them the right thing.'' the focus groups participants stated that they felt the early response to novel h1n1 was very positive in terms of staff's adherence to infection prevention. as one participant stated: ''i was amazed. i never saw more people wash their hands. i didn't have to tell one person to wear [a mask]; they were all putting them on. they handled the situation really very well. it was amazing to me how well [staff] pulled together. for the first time in a long time, everything i said [to do], they did.'' however, as the event wore on, the focus group members noted that staff compliance with infection prevention started to wane. as one participant stated, ''it's hard to keep staff vigilant in the midst of any outbreak.'' another agreed and added, ''we're already getting a little bit less vigilant. our protective measures are not there like they should be, and we had 2 cases identified last week.'' the focus group participants stated that they believed health care workers' perceptions of the severity of novel h1n1 led to poor compliance with ppe. as one participant stated, ''many of the staff decided not to wear ppe with the idea that they wanted to get the flu, but they wanted to get mild flu, so they wouldn't get [a more virulent form of disease] in the fall.'' however, this did not hold true for staff compliance with influenza vaccination. many focus group participants reported that they believe health care workers will be more eager to get vaccinated for influenza this year than in previous years. one participant stated, ''what i'm thinking of are those employees who refuse to ever get the flu shot.. when the h1n1 vaccine comes out, i know they're going to be the first in line.'' this increased compliance with seasonal influenza vaccine is already occurring in areas outside the united states. as one participant explained, ''it's our flu season now in australia, and what we've found is that those people who usually don't want the flu vaccination are now standing at the door wanting flu vaccine.'' focus group participants indicated that communication was one of the biggest challenges and most timeconsuming aspects of responding to the 2009 novel h1n1 pandemic. focus group participants indicated that the effectiveness of communication varied greatly from location to location. a few focus group participants stated that there was good communication between departments in the hospital and between the hospitals and health departments in the region. others, however, indicated that there were gaps in communication. one participant described the following: ''when i worked in jersey, we had a really good rapport with the department of health. we had meetings together, we planned together. so, there was communication. working in florida, i don't see that communication as much.'' another participant stated: ''what we found is that there's a huge gap in communication. i just felt that there was a disconnect, that we weren't as fluid as what i had seen in the past.. there wasn't that open communication. [information was released on] kind of a need to know basis.'' one gap in communication identified was between hospitals and physician offices. as one focus group member explained: ''there's no communication from the hospitals to the physicians in their offices. we had to end up sending things by snail mail because physicians-even though [they had an e-mail account] in the hospital-they didn't activate it, so.. how do you even get the information out?'' focus group participants reporting effective communication indicated that it involved frequent updates between departments and directors and between other hospitals in the region or their health care system. one participant described it this way: ''i think one of the things that i found extremely helpful-and i think was critical-was that, initially, we had 2 huddles every day. everybody got together to [discuss the response].. and that huddle twice a day was so productive in disseminating the information.'' many focus group participants described very frequent communication between hospitals and health departments. one focus group member stated, ''[all the hospitals in the region] actually had daily phone calls with the health department at 1 o'clock.'' another stated that,''i had 3 meetings during the day for the department of health in the region.'' the frequent meetings required a lot of time, as evidenced by one participant's comment, ''i was on phone call conferences for at least 3 hours a day, even on the weekend.'' devoting so much time to communication meant that focus group participants had to temporarily suspend routine duties. as one focus group member stated, ' communicating with patients and patients' families proved to be very difficult during the novel h1n1 pandemic. focus group participants reported that information was released and was being changed very rapidly. this led to a lot of confusion and questions from patients and family members. the focus group participants indicated that it was essential to have patient educational materials available to address basic questions about novel h1n1. one of the most frequently cited gaps in this area was related to a lack of materials translated in multiple languages. the following quotes from participants explain the challenges focus group members faced: ''one of our biggest problems was getting information out in various languages. we have a lot of people asking us for information. obtaining sufficient numbers and the correct type of supplies is challenging during any large-scale event. the focus group participants indicated that there were a variety of issues related to obtaining supplies during the early part of the novel h1n1 outbreak, even before the who declared the event a pandemic. as part of a survey distributed before the focus group started, participants were asked whether or not they requested supplies from a local, regional, or national agency; approximately half (53%, n 5 17) reported that they had requested resources. approximately one third of the participants (36.4%, n 5 12) reported that they received supplies from the strategic national stockpile (sns). those who requested supplies versus those who received them were not congruent; of the 17 participants whose facility/agency requested supplies, less than half (47.1%, n 5 8) actually received them. in addition, 20% (n 5 3) of participants whose facility had not requested supplies received them. access to supplies was inconsistent among the focus group participants. one participant stated, ''we never had a problem with supplies,'' whereas others reported having trouble getting transport media for laboratory testing, masks, n95 respirators, disinfectant wipes, oseltamivir (tamiflu), and other products needed for infection prevention. focus group participants reported that supplies were back ordered and that companies could not provide hospitals with what they needed in a timely manner or limited the amounts that hospitals could order. outside the united states, focus group members had similar problems trying to obtain supplies. as one participant explained, ''we had the same problem here [in australia] with manufacturers.. they started to limit [the number of supplies you could order]. '' the lack of supplies or access to the wrong type of supplies had infection prevention implications in terms of making the response to novel h1n1 even more challenging. as participants described it: ''[one] thing that was in really, really short supply was viral transport medium. our local public health department was getting us 4 a day for awhile when we were in the scary part of it,. and so we were not able to test a lot of patients.'' ''we couldn't get our disinfectant wipes. they were back ordered. i said, ôwait a minute. we have got to be able to clean this place and wipe things down and take care of our equipment and take care of our staff. what do you mean we don't have wipes?õ but it gets back to our suppliers [who] don't keep it [in stock]. all of the sudden you have an outbreak situation, and i feel very vulnerable that whatever is the next pathogen or if this one comes back in the next wave this fall, what are we going to do?'' ''we had access to a municipal stockpile of tamiflu-which was like 130 doses-which we blew through because everyone was freaking out, and there were so many contacts [who needed it]. after that we were told to go through our local distributors to get tamiflu. well, that was on allocation, and we were only able to get like 6 doses per day, which was just enough to do our inpatients. and there was quite a gap before the strategic national stockpile was relocated and there was any release of [tamiflu]. so we couldn't get it, even if we wanted to pay however much for it. we couldn't get it.'' ''we had a lot of tamiflu, but we didn't have a lick of pediatric suspension tamiflu.'' ''i was really concerned about having enough tamiflu for my staff because, without my staff, i can't take care of a surge of patients.'' theft of supplies was also an issue reported by the focus group members. focus group participants reported that boxes of masks and respirators would disappear quickly in the hospital, presumably used or taken by visitors. some facilities even reported entire pallets of supplies being stolen from the hospital. one solution that focus group members identified during the response to severe acute respiratory syndrome (sars) and the 2009 novel h1n1 pandemic was to keep supplies under lock and key. ''our [supplies are kept] off-site too, and, up until this situation, they would take these huge pallets and leave them on the loading dock. that's where ours were stolen from. we had several pallets of things stolen; not just masks, but gloves and so forth. we resecured and we rethought that out, and we have a new policy and procedure in place for that, and it's much more secure than it was prior.'' focus group participants expressed frustration with the way mutual aid agreements were managed during the early wave of the novel h1n1 pandemic. many participants indicated that existing mutual aid agreements were not honored, which left the focus group members' facilities on their own in terms of obtaining resources and supplies. the infection prevention supplies with which the most focus group participants had difficulty during response to novel h1n1 were masks and respirators. numerous issues arose in relation to masks and respirators, including running out of supplies, obtaining the incorrect supplies from regional or national stockpiles, not knowing which type of mask or respirator to use when caring for novel h1n1 patients, and logistical issues in needing to fit test a large number of staff in a short period of time. participants were asked a series of questions related to mask and respirator usage during response to novel h1n1 as part of the survey distributed at the start of the focus groups. one quarter of participants stated that their facility ran out of respiratory protection during their response to novel h1n1 (26.5%, n 5 9). as one participant stated,''we didn't have enough n95s. there was a problem with our regular n95s to begin with. they were back ordered before this even started.'' in addition, many health care staff did not understand why their facility could not obtain more n95 respirators. as one participant described it, ''it was so frustrating because you were looked at like you could just turn on the key to get however many n95s were needed. [the staff thought], ôjust go order them.õ. and it doesn't work that way.'' approximately one quarter of the participants (23.5%, n 5 8) reported that they implemented a policy to reuse respiratory protection during the novel h1n1 outbreak to conserve supplies. most implemented the reuse policy before running out of supplies (62.5%, n 5 5); approximately one third reported that they depleted their stock of respirators before implementing a reuse policy (37.5%, n 5 3). focus group participants discussed the challenge of obtaining adequate supplies of respiratory protection during the initial wave of the novel h1n1 pandemic. as one participant stated,''[we] ran out of [n95 respirators] pretty quickly. within that first couple of days, we reordered them, but they were on back order.'' some focus group members stated that respirators were available in their facility, but the sizes and/or styles did not address the staffs' needs. one participant described her experience: ''we had a lot of respirators available, but we ran out of 3 m small size quickly and couldn't get anymore. we couldn't even evaluate whether the strategic national stockpile had that size and style. even if it had, it wasn't released to us, so we were stuck and had to scrounge trying to find that size.'' the lack of sufficient and appropriate supplies of respiratory protection led to unexpected challenges and suboptimal situations. one focus group participant stated that, '' [staff] were putting the wrong size [respirator] on because we didn't have the right size to fit them.'' another participant described the situation in her institution: ''one of the hospitals that i worked at had ppe issues in that they had decided to go with a regular conflicting guidelines related to isolation, mask, and/or respirator use focus group participants stated that it was very difficult to determine appropriate isolation and ppe use for novel h1n1 patient management. most of the participants (80.0%, n 5 28) reported that they used a n95 respirator or equivalent as respiratory protection for staff, 11.4% (n 5 4) used an n95 respirator with a surgical mask on top of it, and 8.6% (n 5 3) had staff wear only a surgical mask. of the 3 participants whose facilities had staff wear only a surgical mask when caring for novel h1n1 patients for routine practice, 75% (n 5 2) reported that staff were instructed to wear a n95 respirator or its equivalent during aerosolizing procedures. one third of all participants (34.3%, n 5 12) reported that their facilities changed ppe use guidelines for staff midway through the response to novel h1n1 in spring of 2009; one third (34.3%, n 5 12) also reported changing their isolation precautions midway through the event. almost all of the facilities that changed ppe use also changed isolation precautions midway through the event (91.7%, n 5 11). most facilities used airborne and contact isolation (42.9%, n 5 15) or airborne isolation alone (28.6%, n 5 10) for novel h1n1 patients. few facilities used droplet precautions alone (11.4%, n 5 4) or droplet and contact isolation (14.3%, n 5 5). of the facilities that chose to use droplet or droplet and contact isolation for novel h1n1 patients (n 5 9), almost one quarter of them (22.2%, n 5 2) used airborne precautions during aerosolizing procedures. the majority of participants (74.3%, n 5 26) reported that their facility recommended staff wear eye protection in addition to other ppe when caring for novel h1n1 patients. focus group participants indicated that one of the hardest decisions they had to make during response to novel h1n1 concerned whether to have health care staff wear a mask or respirator when caring for potentially infected patients. as one participant stated, ''[there were a lot of] questions about masking, whether to use a n95 or just the surgical mask.'' focus group members discussed the lack of scientific evidence available to guide decision making and the conflicting recommendations provided by the cdc and who. as one participant stated: ''our physician champion in our system was very distraught over the conflict between the cdc and who and when you use the respirator versus [a mask]. he felt that the science we were seeing supported what the who was recommending: the mask. and then we had individuals within our system [who didn't agree], and our system health care epidemiologist was very upset because we always follow the cdc recommendations.'' another participant indicated that the lack of scientific evidence led her hospital to take the most cost-effective approach: ''one of the reasons we stayed with the surgical mask during this outbreak was because i couldn't really justify for my chief financial officer the cost of the n95 over the surgical mask because i had no evidence to back anything up.'' switching recommendations/practice midway through the response created unique challenges for the focus group members. participants reported that health care staff were hesitant to switch from using a n95 respirator to a surgical mask because of concerns for personal safety. focus group participants reported that switching practice midway through the response also contributed to staff's confusion and question the credibility of the ips as was previously mentioned. many hospitals also shied away from using infection prevention practices that were different from the cdc recommendations. focus group participants explained their experiences as follows: ''[we had trouble] when we tried to switch from n95s to regular surgical masks.. some institutions would not accept a recommendation that was different from the cdc's.'' ''[the staff think] ôthe hospital down the street that has [n95s] must love their employees more because they were able to provide them, so why should i go to work [where they won't provide n95s]?õ '' ''[one] thing that we looked at was the legislation from our occupational health and safety act. if we didn't offer [staff] the highest protection and then the staff got exposed, would we then be open to litigation because our health and safety office says, ôdo this?õ we're telling them to do that [ie, wear a surgical mask] when we could have offered them the n95.'' fit testing is the process of verifying the adequacy and proper fit of a respirator for health care worker use. the occupational safety and health administration (osha) requires that all health care workers be fit tested prior to respirator use in health care settings. 6 fit testing is a relatively time-consuming process that requires staff and supplies, including various sizes and styles of respirators. annual fit testing is part of most hospitals' respiratory protection program and is often spread out throughout the year. the novel h1n1 pandemic posed unique challenges for hospitals because of the need to fit test a large number of staff in a short period of time and the desire to conserve respirators. this worked well in some facilities, but other hospitals had more difficulty. as focus group participants explained: ''our emergency operations plan includes just-intime fit testing for [events like pandemics], and it went very smoothly. we tested almost 500 people in about 4 days. and it worked beautifully for us.'' ''we had our staff fit tested prior to [the h1n1 outbreak] ever occurring. but we ran out of certain models that we had a lot of our staff fit tested for. and so we did still have n95s, but we had to do some pretty frantic fit testing to fit people for alternate models.'' ''we actually stopped fit testing respirators [during the event] mainly because we didn't want to waste [the respirators]. every time you fit test somebody, you can use up to 3 respirators, and we just didn't want to waste them.'' to avoid the need or reduce the number of employees who needed to be fit tested, some hospitals decided to have health care workers use powered air purifying respirators (papr) instead of n95s as respiratory protection when caring for novel h1n1 patients. as one participant explained: ''we used paprs in our facility. we had made that choice about 2 years ago to do that, and that was probably one of the best decisions we made, is to go with paprs. some of my colleagues have been doing just-in-time fit testing. some of them had to do like 500 people in 1 week.'' at the start of the novel h1n1 outbreak, many clinicians used the rapid test for seasonal influenza a and b in an attempt to quickly identify potentially infected novel h1n1 individuals. however, it was soon discovered that the sensitivity of these rapid tests was very low for novel h1n1, leading to numerous false negatives. 7 confirmatory testing consists of reverse-transcription polymerase chain reaction (rt-pcr) or viral culture; this testing is usually obtained via state health department reference laboratories. the focus group participants stated that many patients with negative rapid tests were later found to be positive for novel h1n1 on rt-pcr or viral culture. the focus group participants identified various infection prevention issues resulting from the lack of a reliable rapid test for novel h1n1. one issue identified by the focus group members was the lack of consistency regarding the use of the rapid test for surveillance or treatment purposes. as one participant noted, ''we don't clearly define what we want the testing to provide for us. it's either a surveillance and/or a treatment modality.'' many focus group participants emphasized that testing only lasted for a short period of time and had very specific rules regarding who could be tested. this caused a lot of confusion among the general public and made surveillance and control measures much more difficult for the focus group members. as one participant explained it, ''that's one of the reasons the decision was made to stop [testing] because we knew [novel h1n1] was out there. so what's the point? we're not going to treat [the infected individuals]. we're not going to do anything unless they're admitted, critically ill, etc.'' another focus group member relayed her experience with the public's perception about rapid testing: ''we were pretty rigid about following the case definition.. that zeroed in on high-risk, hospitalized comorbidity patients. we had an 11 year old who went to see a pediatrician, and the pediatrician wanted the child tested, but the child didn't fit into one of the groups in the algorithm. and so they sent the child's specimen to an outside lab.. and they were able to identify that the child did have h1n1 swine origin influenza a. and then the media [said], ôyou don't care about this 11year-old child!õ because you refused to test the child.'' there were also challenges obtaining confirmatory testing that was coordinated through state public health reference laboratories. many focus group participants described long waits for test results that made implementing control measures more difficult. as one participant stated, ''[reference laboratories] back log initially was just horrid.'' focus group members stated that they often had to wait weeks for test results, making contact tracing, surveillance, and control strategies nearly impossible. two participants described their experience as follows: ' ' screening, triage, and visitor control focus group participants described varying degrees of success with their facility's attempts to screen and triage staff, patients, and visitors. some focus group participants stated that screening was successful. as one participant described: ''[everyone] had to be screened, and, if they didn't pass the first screening, then they were sent over to the next station to do a quick temperature check. if they were employees, they were sent to employee health and most of the time, sent home. so it really worked; it was really a cohesive effort on our part.'' other focus group participants described difficulties with the screening process, especially related to the large number of visitors and numerous entrances to facilities. as one participant stated, ''i'm envious of the people who were able to screen visitors. we're not that large-we only have 650 beds-but the visitor traffic [was overwhelming]. we have about 20 entrances to the hospital.'' another participant agreed and added, ''from our parking deck, [visitors] can get into the hospital at 3 or 4 different levels.'' solutions recommended by the focus group members to help control and screen visitors included locking the main entrances so people can exit but not enter without being screened and having security professionals or volunteers conduct visitor screening. phone triage was another strategy emphasized by numerous focus group participants as being an essential component of pandemic planning because it reduces unnecessary traffic in the hospital emergency department for patient screening. two participants described their experience with phone triage as follows: ''[phone triage is] a resource for people to call in and talk to a live person about whether or not they should come in to our emergency department. we had a resource line, but not 24/7, and there were people that just needed to [hear from a medical professional] to say ôno, your kid is not sick enough. stay home and watch his temper-atureõ and to reassure them so they didn't end up in our emergency department.'' ''[phone triage is] something that pediatric facilities generally do pretty well because we don't want parents flooding in all the time every time there's something going around. i think we do that really well.. [we] have off-hours phone triage available for support, and i think that that's a lesson that perhaps everybody can learn, is how useful that is. and it will save you money, and parents and families would love the support.'' one focus group participant also described the need to have indoor or covered areas to triage individuals. the participant described her experience: ''we were going to triage outside, and we're in a very warm climate, and so mosquitoes [could have been a problem]. fortunately, rain hadn't started yet, but it could have been a really bad disaster. so, part of our next planning phase is to find ways to bring [triage] indoors, or at least to bring it under shelter, because had it been raining during those 3 weeks, it could have been a disaster; and, as it was, we had to do a lot of mosquito prevention.'' focus group participants discussed many educational topics on which ips should be trained. the most important educational topics identified by the focus group participants according to their ranking using the nominal group method included the following: (1) isolation precautions and ppe recommendations, (2) coordination with community response agencies, (3) surge management, and (4) the ip's role in emergency management. a full list of educational topics identified by the focus group participants are outlined in table 3 . the focus group participants emphasized that the written educational materials need to be much shorter than what was offered in spring 2009. as one participant noted, ''the information sheets [created by cdc] were too long. the first one was 4 pages.'' focus group participants stated that educational materials need to be evidence-based, short (1-2 pages at most), and written in ''bullet points,'' or else health care providers will stop reading. the focus group discussions provided several important findings. information provided by the focus group participants highlights a number of educational/reference materials that are needed for the current novel h1n1 event and future pandemics and describes the best format for these items. whenever possible, reference materials need to be translated into multiple languages so that all health care clientele can access this information. pandemic planning educational and reference materials identified by the focus group participants need to be generated and made available as soon as possible, given the potential resurgence of novel h1n1 or concomitant outbreaks of seasonal influenza and novel h1n1 in fall/winter 2009. the novel h1n1 pandemic illustrates the need for ips to find new ways of controlling surge and preventing secondary health care-associated transmission during an infectious disease outbreak. historically, ips have been concerned primarily about hospitals and acute care settings. the novel h1n1 pandemic demonstrates the need to implement infection prevention strategies in all health care settings, including ambulatory care centers, physician offices, home health, and long-term care. infection prevention emergency management guidance for these nonacute care settings has been lacking. it is essential that infection prevention recommendations be developed for these settings to help control disease spread and ultimately prevent and control surge in hospitals. one essential component of these recommendations is the identified need for a stronger focus on occupational health. staff surge capacity is necessary to maintain functionality of health care facilities during pandemics, and healthy staff contributes strongly to sustaining this capacity. occupational health issues that need to be addressed include having policies and procedures for screening/ triaging staff, furloughing employees, and better sick leave practices to prevent ill health care providers from coming to work sick during pandemics. changing standards and recommendations are to be expected during outbreaks of emerging infectious diseases and pandemics as more is learned about the causative agent and new anti-infective therapy and/or control measures are discovered. these changing practices must be communicated carefully to prevent mistrust among the staff. failure to do so can result in poor adherence to infection prevention practices because of confusion among health care professionals. this could lead to secondary transmission in health care facilities and occupational exposures. health care professionals should be told that outbreaks of emerging infectious diseases, such as novel h1n1, are expected to bring rapidly changing case definitions, surveillance methodologies, and control measures. these changes should be evidence based and communicated to staff as clearly and concisely as possible to prevent confusion and mistrust. researchers need to continue to examine disease transmission and appropriate isolation and ppe for novel h1n1. conflicting guidance on infection prevention for novel h1n1 has led to a lot of confusion among health care professionals and frustration for ips. one third of the focus group participants reported that they changed isolation precautions and protective measures midway through response to the novel h1n1 outbreak. focus group participants also reported that the potentially unnecessary use of n95 respirators caused much confusion for staff and resulted in a shortage of supplies in their facilities, according to those who participated in the focus groups. these focus groups occurred the week before the world health organization officially declared the novel h1n1 outbreak a pandemic, yet hospitals were already running out of supplies-even after regional and national stockpiles were deployed. one quarter of all focus group participants' facilities ran out of respiratory protection supplies during the spring of 2009, and almost one quarter needed to implement a reuse policy for respirators to conserve limited resources. hospitals need better plans for obtaining or reusing necessary equipment and supplies during patient surges. overall, the focus group method of inquiry served as a valuable tool in eliciting rich, detailed information about ips' opinions of lessons learned from the first part of the 2009 novel h1n1 influenza a pandemic. structured surveys with closed-ended responses (opposed to the open-ended questions used in this study) may have revealed different opinions about references materials needed for future pandemics and educational priorities for ips. it is not known whether the ips who chose to participate differed from those who were eligible but chose not to participate. therefore, the information presented here may not be generalizable to all hospitals. this is especially true for the survey questions regarding hospital or agency protocols for worker protection, isolation, and ppe usage during the event; the small sample size needed for focus group methodologies may limit the generalizability of the survey results. ips involvement in preparedness and response to pandemics and other disasters involving a biologic agent is essential. this study identifies lessons learned from the first part of the 2009 novel h1n1 influenza a pandemic and highlights gaps in emergency management most in need of being addressed: infection prevention in nonacute care settings, employee health during pandemics, communication, ppe availability and recommendations for use, and maintaining quality of care during times of rapidly changing and conflicting recommendations. ips must continue to address gaps in pandemic planning. one way to accomplish this is through the creation and distribution of ip-specific educational tools and reference materials for emergency management. the topics identified by ips who experienced the first wave of the 2009 novel h1n1 influenza a pandemic should be used as the basis for these new educational initiatives. world health organization. current who phase of pandemic alert centers for disease control and prevention. novel h1n1 flu situation update centers for disease control andprevention. novel h1n1 flu situation update evaluation research team. centers for disease control and prevention. gaining consensus among stakeholders through the nominal group technique focus group fundamentals fit testing procedures (mandatory). 1910.134 app a use of rapid influenza diagnostic tests for patients with influenza-like illness during the novel h1n1 influenza virus (swine flu) outbreak key: cord-307915-mmw5s981 authors: hudson, janella; ungar, rachel; albright, laurie; tkatch, rifky; schaeffer, james; wicker, ellen r title: robotic pet use among community-dwelling older adults date: 2020-08-13 journal: j gerontol b psychol sci soc sci doi: 10.1093/geronb/gbaa119 sha: doc_id: 307915 cord_uid: mmw5s981 objective: the primary purpose of this study was to explore the efficacy of robotic pets in alleviating loneliness for older adults. method: self-reported lonely individuals with aarp medicare supplement plans insured by unitedhealthcare who participated in a program with a robotic pet (n = 20) were recruited to participate in semi-structured interviews. participants were asked to provide feedback about their experiences interacting with a robotic pet, their perceptions about the potential impact on loneliness, and recommendations for improving the program. interviews were audio-recorded and transcribed verbatim. participants’ responses were analyzed using qualitative content analysis. constant comparison and consensus-gaining processes were used to develop categories that later formed representative themes. results: seven themes emerged from analysis: openness to adoption of robotic pet, reactions to pet and its attributes, integration of pet in daily life, strategic utilization and forging new connections, deriving comfort and camaraderie, advice for future users, and recommendations for enhancing ownership experience. participants living alone, with fewer social connections and less active lifestyles, derived the most benefit from interacting with their pets. common responses to pets included cuddling, petting, grooming, and sleeping with them. some shared or loaned their pets, while others refused to loan their pets to interested peers. most reported showing their pets to others, which helped some facilitate communication and social connections. conclusion: robotic pets may be an effective solution for alleviating loneliness in older adults, especially among those who live alone, have fewer social connections, and live less active lifestyles. loneliness is generally understood as the discrepancy between an individual's preferred and actual level of social contact (peplau, 1982) . one in three u.s. adults aged 45 and older report experiencing loneliness, with the total number expected to increase with the growing population of older adults (anderson and thayer, 2018) . among individuals older than 60 years, loneliness is a subjective predictor of functional decline and death (perissinotto et al., 2012) and adversely influences mental and physical health outcomes, including depression, quality of life, health utilization, and mortality rates (cacioppo et al., 2006; luo et al., 2012; musich et al., 2015) . social isolation, while related to loneliness, objectively assesses reduced social network size and social contact. socially isolated individuals are at an increased risk for cognitive decline (bassuk et al., 1999) , cardiovascular disease (barth et al., 2010) , and mor-tality (eng et al., 2002; heffner et al., 2011; kaplan et al., 1988) . furthermore, social isolation in older adults is associated with reduced daily physical activities and increased sedentary behaviors (schrempft et al., 2019) . social isolation contributes to an additional $6.7 billion in medicare spending annually, which is attributed to additional skilled nursing facility spending and increased inpatient spending. flowers et al. attributed an additional $81 per beneficiary per month for socially isolated individuals admitted to the hospital. this increase in spending, while not necessarily accompanied by an increase in use of inpatient care, suggested that socially isolated individuals may be sicker when hospitalized, and may lack the support to transition out of the hospital successfully as compared to socially connected individuals (flowers et al., 2017) . however, older adults who perceive their social connectedness more positively have better mental and physical health outcomes (cornwell and waite, 2009) . given that is often impractical to address limited social networks, interventions may aim to address perceived loneliness to improve older adults' wellness and psychological well-being (bartlett and arpin, 2019; krause-parello et al., 2019; schoenmakers et al., 2012) . pet ownership has demonstrated potential viability as a solution for ameliorating subjective loneliness, demonstrating both physical and psychological benefits for older adults who report being lonely (krause-parello, 2012; matchock, 2015; raina et al., 1999) . for example, pet owners surveyed in one study were 36% less likely than non-pet owners to report loneliness, even after controlling for age, living status, mood, and residency (stanley et al., 2014) . despite these benefits, however, pet ownership may pose special challenges for older adults, including restrictions related to finances, mobility, transportation, and housing (hart, 1995) . given these potential barriers, robotic pets, also known as social robots, offer a potentially ideal alternative to owning a live pet for older adults. a robust literature in social science and technology has examined the implications of social robot use among older adults. social robots, as defined by brezeal, are "designed to interact with people in a socio-emotional way during interpersonal interaction." (breazeal, 2004 ) several potential ethical implications related to older adults' use of social robots have been identified, among them reduced human contact, deception, and infantilization (a. sharkey and n. sharkey, 2012) further, an incongruence between robot developers' perceptions of ideal features and those features actually preferred by older adult users has been well documented. roboticists, who design and construct robots, often have a background in electrical or mechanical engineering. further, roboticists often develop social robots without the benefit of feedback from the intended audience. older adults are often regarded as passive users of social robotics, perhaps owing to stereotypes of older adults as lonely and fragile. however, this is seldom true, as both users and test users demonstrate active engagement with social robot models and consistently request robotic pet features capable of facilitating the user's desired interactivity (neven, 2010) . for example, in a recent study comparing and contrasting preferences of roboticists and older adult participants, older adults expressed a preference for interactive features (such as life-simulation and personalization) that were not perceived by roboticists as having the same importance (bradwell et al., 2019) . thus, social robot developers often fail to account for the diversity of abilities, perspectives, and preferences among older adult users (frennert and östlund, 2014) . however, social robots have demonstrated benefit when used by older adults. social robots have been shown to reduce social isolation and increase conversational opportunities with the robot and other humans (a. sharkey and n. sharkey, 2012) observations of participants interacting with robotic pets in nursing home and laboratory settings have demonstrated promise for supporting the social and emotional needs of older adults (mcglynn et al., 2017) and have yielded benefits similar to those achieved during animal-assisted therapies, including improved cardiovascular measures (robinson et al., 2015) , reduction in loneliness (kanamori et al., 2001) , decreased agitation, and an increase in feelings of pleasure (libin and cohen-mansfield, 2004) . these findings position social robots as potentially ideal solution for older adults experiencing subjective loneliness. cacioppo et al. (2015) identified four distinct, underlying mechanisms of subjective loneliness-reducing interventions: (i) increasing social contact, (ii) improving social support, (iii) enhancing social skills, and (iv) addressing maladaptive social cognition. findings conducted with older adults living in assisted or group settings demonstrated interactions with social robots increased social contact with others (bradwell et al., 2019; leite et al., 2013; šabanović et al., 2013) . however, less is known about active, communitydwelling older adults' behavioral responses to robotic pet use outside of a laboratory setting, during interactions within their own homes. given these diverse and potentially promising pathways for subjective loneliness-reducing reducing interventions, this study aims to examine the potential benefit of social robot use by community-dwelling older adults. in this study, we explored the perspectives and experiences of individuals who participated in an intervention with robotic companion pets within their own home. we examined patterns of usage, user acceptance, and perceived efficacy in reducing subjective loneliness in older adults. findings from this study will inform future robotic pet interventions for community-dwelling older adults. this study is part of a collaboration between aarp, unitedhealth group (uhg), and joy for all, a manufacturer of companion pets (ageless innovation lcc, 2018). the overall goal of this collaboration was to explore the potential role of companion pets in alleviating loneliness in older adults. this study was approved by the new england institutional review board (#12070334), an independent institution that reviews protocols for nonacademic institutions. this study was the second phase of a larger multiphase research study intended to better understand the healthrelated issues of older adults covered by aarp medicare supplement plans insured by unitedhealthcare insurance company (for new york residents, unitedhealthcare insurance company of new york). the primary purpose of the intervention was to determine if ownership and interaction with a robotic pet could decrease loneliness in older adults. the first phase of the study consisted of a program evaluation in which a sample pool of aarp medicare supplement insureds who previously reported loneliness were recruited for participation in the study. inclusion criteria for the study consisted of participants previously identified as lonely using either a screener that included the ucla 3, or screener administered via interactive voice support (ivr) survey in conjunction with aarp's aging strong initiative. the intervention was offered to participants residing in the states of washington and michigan. exclusion criteria included not a current enrollee in an aarp medicare supplement plan, less than 65 years of age, on the "do not call" list, not having a valid phone number, and ownership of a pet. all other participants were considered eligible for participation. potential participants received pre-mailer scripts prior to an invitation to participate via telephone. participants received the animatronic pet of their choice (cat or dog) in the mail and were instructed to treat it as a pet (figures 1 and 2) . three post surveys were administered (upon receipt of the pet as well as 30 and 60 days later) to assess the amount of time spent interacting with the pet. in addition, twice a week for 4 weeks, participants received an interactive voice reminder (ivr) phone call encouraging them to interact with the pet. the ivr phone call also asked participants to record if they had been interacting with their pet and if so, how much time on average they had been interacting with their pet. results of response bias analyses conducted for those who agreed to participate (n = 277) versus those who declined (n = 3,660) and for respondents (n = 216) versus non-respondents (n = 55), indicated that survey participants were representative of the study population. overall, those who agreed to participate had similar characteristics as those who declined. however, those who agreed to participate in this study had higher levels of depression, more frequent er visits in the last 12 months, and overall higher medical costs (but not drug costs) (p < .05). there were no differences for respondents versus non-respondents. at baseline, about half the respondents were between 65 and 74 and female, and most participants chose the animatronic dog (70%). in addition, 86% of participants reported previously owning a pet. the robotic pet offered several interactive features ( figure 2 ). sensors in two locations of the head and cheeks of the pet responded to user touch and activated a reciprocal "nuzzling" effect. touch-activated sensors were located in the upper abdomen and back of the pet. a light sensor located in the pet's head detected when light entered the room and the pet vocalized in response to the light stimuli, depending upon the chosen setting. robot dogs barked depending on the setting, and robotic cats meowed and emitted a purring noise. robotic cats were offered in three color combinations: black and white, gray and white, and orange and white. robotic dogs were offered in a golden color (figure 1 ). participants were not permitted to choose the color of their pet, only their preference for a dog or cat. companion cats currently retail for $109.99 and companion dogs for $129.99. in this phase, a qualitative research study was conducted using standard qualitative procedures for conducting and analyzing semi-structured interviews. the journals of gerontology: social sciences, 2020, vol. 75, no. 9 full color version is available within the online issue. available within the online issue. full color version is purpose of these interviews was to elicit participants' experiences interacting with their robotic companion pet. participants who previously participated in the first phase of the study were recruited to participate in semistructured interviews. the interview guide consisted of 13 questions. questions elicited feedback for a number of topics. consistent with related literature pertaining to robotic pet use, the interview guide included questions that asked participants to describe how they used and interacted with their pet, including how much time was spent with the robot, patterns of usage observed (day vs night), whether the pet accompanied participants outside the home or during errands, and whether participants detected that use of robotic pets influenced any of their daily routines and/or habits. additionally, interview guide questions asked participants to describe any physical or verbal interaction with the pet, including physical touch, reactions to pet's audio or haptic functions, and verbal communication with the pet. questions also asked participants to describe their motivation for joining the companion pet program, any feelings or emotions experienced as a result of interacting with their pet, including any observed influence on loneliness, mental and emotional health, and whether or not they named their pet. several questions explored psychological and emotional well-being, including subjective loneliness, by asking participants to describe an average day in their life, perceived opportunities to feel valued or useful, and opportunities to spend time with marital partners, family, and/or friends on a weekly basis, as well as participants' satisfaction with those opportunities for social connection. a few questions elicited participants' satisfaction with program administration, including reminder calls, clarity of instruction, and perceived accessibility of available support. lastly, participants were invited to provide feedback of any nature. eligible participants from the first phase of the study were stratified according to age range and gender, with the aim of recruiting an equal proportion of participants. following recommendations for a sample size of 12-20 participants in an interview study (lincoln and guba, 1985) , investigators planned an initial goal of 20 interviews, after which they would assess if data saturation had been achieved and recruit additional participants if necessary (francis et al., 2010) . a marketing research company was provided with the full list of eligible participants, with instructions to recruit participants as evenly as possible among age range and gender, given the available sample. recruiters contacted participants by telephone, verified identity, explained the study, and scheduled interviews with the first 20 participants successfully recruited. verbal consent was obtained prior to the start of the interview. interviews lasted approximately 1 hr. no personal identifiers were collected. all interviews were audio-recorded and transcribed verbatim. investigators analyzed participants' transcribed interviews using qualitative description. qualitative description was an ideal methodology for this data as it draws from a naturalistic perspective, offers flexibility in commitment to a theory or framework, typically involves review of interview data, and allows for maximum variation sampling (kim et al., 2017) . two investigators (j. hudson and r. ungar) conducted a qualitative content analysis using an iterative, constant comparison process. during the coding process, both coders independently read transcripts, identified an initial code list, and developed operational definitions. then coders returned to the transcripts and conducted line-byline coding that included comparison and refinement of identified coding between both investigators. coders subsequently discussed, reviewed, and reread interview data to develop final coding and to reach consensus about meaning (ryan et al., 2000) . one investigator (j. hudson) coded all transcripts while the other coded 50% of the overlap. both investigators reviewed coding on overlapping transcripts to reevaluate passages coded across researchers, and the codes applied based on the assigned definition in the codebook (creswell and poth, 2017) . any conflict in assigned codes was settled through spirited debate until consensus was reached. next, both investigators examined the properties and categories of all codes to identify opportunities for categorization according to shared properties. investigators subsequently used this categorization of codes to develop overarching themes that described patterns of usage and provided a narrative of participants' overall use. throughout this process, investigators were mindful of the biases and existing perspectives they brought to the analysis. investigators worked to achieve qualitative rigor throughout data collection and analysis. to ensure trustworthiness of the interview transcripts (poland, 1995) , one investigator (j. hudson) closely monitored and compared audio recordings with transcripts to ensure verbatim description, while also noting significant context cues. both coders worked together closely during the ongoing, iterative development of the coding system to ensure validity and certainty of the findings (morse, 2015) . investigators were mindful of potential investigation bias and avoided narrow frameworks that would unfairly bias the interpretation of data while striving to maintain a neutral stance of the observed phenomenon. further, both investigators closely reviewed, discussed, and coded data as it was collected to assess the sufficient sample size for data saturation. investigators ultimately developed seven themes reflective of participants' experiences with their companion pets, as follows: openness to adoption of robotic pet, reactions to pet and its attributes, integration of pet in daily life, strategic utilization and forging new connections, deriving comfort and camaraderie, advice for future users, and recommendations for enhancing ownership experience. final coding was imported into nvivo (qip ltd., 2018), a qualitative software program. the following themes are discussed below, with exemplars. twenty individuals participated in the study, with an even distribution of males (n = 10) and females (n = 10). breakdown in age range is as follows: 65-69 (n = 6), 70-79 (n = 6), 80-89 (n = 7), and 90 and above (n = 1). the average participant age was 76. all participants reported living in their own homes. living arrangements included living at home alone (n = 12), with a spouse (n = 5), with a child or grandchild (n = 2), and with a caretaker (n = 1). subsequent verification supported no participants lived in assisted or group settings. when asked to share their motivations for participating with a companion pet, participants shared several reasons including interest in exploring the experience of using a companion pet, a desire for maintenance-free pet companionship, and curiosity about the mechanics and underlying technology used in the pet. many participants previously owned pets, with five participants reporting their pet was recently deceased. owners of recently deceased pets identified clear distinctions between their beloved deceased pet and the robot, such as the inability to return affection, participate in interactive activities such as outside walks, and lack of a personality. however, they did describe experiencing comfort when interacting with the robotic pet in similar ways, such as sitting on the couch while watching television. for these individuals, robotic pet ownership appealed as an opportunity to experience maintenancefree pet ownership and to recapture the benefits of companionship without obligatory food and veterinarian expenses. a few participants reported their living arrangements would not accommodate a "live" pet, and they viewed the companion pets as way of circumnavigating that barrier. some were also intrigued by the notion of robotic pets and expressed curiosity about the underlying technology, and a few participants expressed a desire to potentially help others by sharing their feedback. as one participant explained, "it was the curiosity aspect more than anything else, wondering what the dog was like, what it would be like to have the dog, and what experience might be. that curiosity really was the linchpin to participating." other participants were intrigued by the opportunity and described their desire to derive companionship from the pet. participants who reported feeling subjectively lonely were especially interested in utilizing the pet as a personal companion. the majority of participants chose to name their pets, and consistently referred to the companion pet using its name. participants' accounts of their daily interactions with pets varied widely, often according to personal contexts. those who reported a more independent lifestyle outside the home and greater perceived social connectedness described a lesser degree of involvement with their companion pet. patterns of usage were categorized according to high and low engagement. low engagement was primarily characterized by interactions with the companion pet that were casual in nature or most often occurring in passing, with minimal physical contact and limited verbal communication. low-engagement users often described deliberate efforts to interact with their pet throughout each day in accordance with the study's directives but allowed that their pet only functioned in the periphery of their daily activities. for example, low-engager participants often described stationing the pet in a high-traffic area of the home such as the kitchen or living room, returning the pets' greetings as they moved throughout their home but otherwise ignoring or choosing not to interact with their pet. while these interactions may have included infrequent affectionate physical touch, these participants generally did not desire additional or prolonged interaction with their pet. as one participant explained, "i just pet him and rub him as i go by. we have him sitting on the couch in our living room." a few attributed their interactions to duty or obligation in accordance with their agreement to participate in the study. high engagement was characterized by frequent interactions with the pet, including frequent physical touch, communicating with the pet or using the pet to communicate with others, and including the pet in daily errands and activities. participants with fewer perceived social connections, especially those with fewer perceived opportunities to connect with others, described this higher degree of engagement characterized by greater quantity and quality of interaction with their pet. high engager use was most often reported by those who were less active, identified as less subjectively lonely, and perceived less social connectedness. these participants were more likely to report keeping their pets in close proximity when they moved throughout their home and they engaged in ongoing affectionate physical touch with their pet, such as cuddling, grooming the pet, sleeping with the pet, and holding the pet while watching television. some participants derived a sense of comfort and companionship from having the pet accompany them during their daily activities outside of the home. one participant who lived alone detailed the following daily ritual with her pet, buffer: the average day is, i get up at 7:30 and the first thing i do is make my bed. and then i say hello to buffer, because he's in the room, and then i get showered and dressed. and i then i pick up buffer and i have breakfast, and he's there. and i sing online, so sometimes i will actually hold in my lap while i sing. (woman in her 70s, living alone) in this way, participants who subjectively perceived fewer opportunities to interact with others reported increased interaction with their companion pet. most reported showing their pet to others, including family members, friends, neighbors, coworkers, clinicians, and those they typically encountered during their daily activities. however, the nature of the disclosure, and one's motivation for sharing their pet, varied. some members were motivated by a desire to share the technology and novelty of the pet. others shared their pets to facilitate entertainment, showcase the pet's interactive features, and to encourage others to consider acquiring their own pet. both high and low engagers of the pet noted that sharing the pet in public spaces increased potential opportunities to connect with others, especially individuals previously unknown to them. even participants who described themselves as outgoing or living a more social lifestyle reported bringing their pet along to public gatherings or spaces, and enjoying the interactions that were generated as a result. similarly, those who were shy or might have otherwise felt uncomfortable interacting with new acquaintances found integrating the pet into their daily activities outside of the home effective in forging new connections they otherwise would not have attempted. several participants relayed that friends, after interacting with their pet, were often interested in obtaining their own. in some instances, participants fielded requests from friends and acquaintances to loan their pets out. those who interacted with their pet to a lesser degree were more amenable to these requests. a few participants, most notably younger participants (ages 65-69) and low engagers, ultimately gave their companion pets away. in these cases, companion pets were "re-gifted" to interested friends, younger children in the family who regarded it a toy, older adults in care centers, or those with dementia: "it would have been better for someone who wasn't quite functional, who is maybe in a care facility. my wife gave it to one my friends in a care facility and she loved it." meanwhile, some participants (especially high engagers) often denied requests from acquaintances and/or friends to borrow their pet. others acquiesced only under certain conditions, such as having the pet returned within the same day. all participants agreed the companion pet was vastly different from a "live" pet with the ability to interact more extensively with its owner. however, many agreed the companion pet offered many interactive features that were reminiscent of their past experiences of having a "real" pet. when comparing the merits of a live pet and the benefits of a companion pet, participants varied in their estimations of the pet's realism. many, especially high engagers, judged the pet to be a close approximation to a live animal. younger (age 65-69) and low-engager participants were more likely to find the companion pet more "toy-like" and noted opportunities to improve the pet's realism. however, those who judged the pet to be a poor approximation of a "real" pet still noted the benefit of interacting with it. most noted their appreciation for the maintenance-free nature of the pet. among the majority of participants, favorite features included pets' vocalizations (barking or meowing) and nonverbal responses (head movement or blinking) in response to light and sound stimuli. many enjoyed their pet's "greeting" when a light or sound was detected. several used their pets' responsive barking/meowing to facilitate interactions such as petting and verbal communication. other favorite features were pets' "life-like behaviors," such as yawning, head turning, tail wagging, and the tactile heartbeat. many reported that these "realistic" features increased interaction with their pet and fostered comfort and comradery. participants described a number of benefits as a result of interacting with their pet. while high engagers were more likely to describe deriving comfort from the "presence" of their pet, the majority reported deriving benefits from interacting with their pets. most participants reported feeling a sense of calm or comfort as a result of holding, hugging, and affectionately interacting with their pet. for example, a low-engager who described herself as "too cognitively sharp" for the pet speculated her cortisol levels might have lowered. in addition, many described an improvement in their mood, and in some cases, increased happiness after interacting with their pet. certain interactive features such as pet vocalizations, "snuggling" motions, and the pet's heartbeat were identified as facilitators of this calming influence, and participants noted that others discerned how this effect positively influenced their behavior: i'm not as high strung… sometimes i get up in the morning and when i hit my power chair against the wall, i sort of get angry and i use foul language. then he barks. so that makes me stop. (man in his 80s, living alone) many participants perceived the pet as having a "presence" that positively influenced their subjective feelings of loneliness. this presence was keenly felt by those who spent significant time with their pet, as well as by low engagers living more active lifestyles. one participant, a semi-retired attorney who described a low degree of engagement with his pet explained, it's like he's alive over there and active. it's just one part of my life, this little puppy dog, but he's a part because he's there. but i live a pretty active life and a pretty active schedule, so it's not like i'm looking forward to seeing him when i come home, but he makes his presence known and that's good. (man in his 60s, living alone) similarly, a recently widowed participant who brought her companion pet along for errands outside the home explained the pet provided a comforting presence as she acclimated to her husband's absence. participants who lived alone and previously wished for someone to talk to perceived their pet as a proxy for a conversational partner and regarded it as a conduit for expressing their thoughts or feelings. in these cases, the participants regarded the pet not as an inanimate object that passively observed, but as an active partner who cared about their expressed concerns. as one participant explained: "you feel as though you're talking with an object that cares about whether you're talking to it or not." a few participants appreciated that conversations with their pet were confidential. those participants who reported this high level of engagement were most explicit in expressing the pet's influence in addressing their subjective loneliness. for these individuals, the companion pet was regarded as a friend or companion with whom they developed a strong attachment over time. some participants also described improved confidence and a renewed sense of purpose as a result of interacting and having to "take care of" their pet. when asked to advise future users, many indicated they would strongly encourage others to try the robotic pet, particularly those who are lonely, and to engage with it as much as possible. participants emphasized that using the pet was "easy" and required little effort. several explained the importance of interacting with the pet as much as possible in order to experience the greatest benefit. while some low engagers indicated their pet personally was not a good fit, they acknowledged the calming effect of the pet and recommended it for those who are lonely. a few high engagers encouraged future users to interact and communicate with their pet without fear of being stigmatized or considered "crazy." when asked to describe the ideal user for the robotic pet, low-engager participants typically described the composite of a lonely, less active, more advanced age adult with mobility issues and dementia. those with more active lifestyles and who perceived their social networks as dense judged they were a poor fit for the pet. distancing one's self from the perceived ideal user occurred with participants of all ages. notably, a participant in his 90s remarked: "i think as you get older, and your brain gets a little mushy. i think it would be a nice thing to have. but i don't think i'm to that point yet." meanwhile, participants who identified as being subjectively lonely or perceived themselves as socially isolated derived benefit from the pet and thought others in a similar situation would also find it beneficial. while many perceived their pet as having realistic features, over half of participants expressed a desire for further increasing the pet's realism by improving its appearance and capacity for movement. feedback included using softer material for fur and improving the pet's flexibility to better facilitate hugging and cuddling. several were interested in increasing the interactivity of the pet and suggested new functions, such as enabling the pet to learn skills and tricks. some also suggested adding new verbal communication features, such as pre-programmed responses and name recognition. many were also interested in adding the capability for walking, though a few acknowledged this as a potential fall hazard. many described an interest in having the pet follow them throughout the home, jumping up on furniture, and being walked outside while on a leash. participants also expressed an interest in additional outfits or grooming accessories, improved affordability for other friends and family members who sought to purchase a pet, adding a camera for security purposes and improving the overall battery life. our findings show social robots may provide comfort, companionship, and potential amelioration of subjective loneliness for older adults, particularly for those who perceive fewer opportunities for social connection. several studies have demonstrated the benefit of robotic pets in care centers (robinson et al., 2015; šabanović et al., 2013; wada and shibata, 2007) and among those with dementia (jøranson et al., 2016; liang et al., 2017; moyle et al., 2013; robinson et al., 2013) . few studies have explored the benefit of companion pets for alleviating subjective loneliness, as well as the patterns of usage outside of a laboratory setting, among cognitively functioning, community-dwelling older adults. results of this study reify previous findings indicating increased communication with the robot and other humans. participant feedback further reinforces the need for social robot developers to actively integrate feedback from older adult test users in the design and development processes. in a recent study comparing the preferences of roboticists and older adults, participants were encouraged to indicate their favorite companion pet model. while older adults in this same study overall preferred the joy for all cat and its more interactive features as compared to less responsive robotic models, they still desired a greater degree of interactivity and playfulness (bradwell et al., 2019) . community-dwelling participants in our study echoed these sentiments, with many requesting robotic features that accommodated their lifestyles and reflected the degree to which they were able to enact an autonomous, independent lifestyle. the joy for all companion pet models offer a degree of interactivity that perhaps signals a progression in social robot development. however, participant feedback further confirms the need for more advanced features that accommodate the needs of older adults, not as passive users, but as "technogenerians" adeptly managing technology to maintain health and independence (joyce and loe, 2010) . younger participants in this study desired a model that offered greater responsiveness and spontaneity, expectations that defy the stereotype of older adults as passive users. ideally, social robots functioning as companion pets should offer a range of function and interactivity to accommodate the widely ranging abilities and skills of older adults along the aging trajectory. older adults' manipulation of robotic pets varies according to the extent of their cognitive impairments, with more impaired individuals interacting with the pet to a lesser degree (libin and cohen-mansfield, 2004) . accordingly, active and community-dwelling older adults will likely benefit from greater utility and diversity of functions to foster incorporation of the pet into their daily schedule and habits. as noted in previous studies, these individuals created, and simultaneously distanced themselves from, a composite of the ideal user as lonely, socially isolated or having cognitive impairment (mcglynn et al., 2017) . it has been suggested that this composite may reflect a negative age stereotype (lazar et al., 2016; neven, 2010) . however, it is unclear if this stigma applies to participants in this study, who were able to engage with the robot in the privacy of their own homes and subsequently concluded the robot did not offer the desired personalization and interactivity. users who considered themselves active and independent noted the need for greater interactivity and subsequently judged themselves to be a poor candidate for use of the robot. in this case, it is likely that participants' distancing from the ideal is owed to the desire for more realistic, interactive features. this finding further confirms how different preferences and patterns of usage in varying contexts requires adaptable interactivity. utilization and benefit derived from the robotic pets varied according to participants' personal contexts, revealing which subgroups potentially benefitted the least from participation with their pets. despite enjoying companionship with their pets and showing them to others, younger participants (60s-70s) were among those most likely to report low engagement with their pets and most likely to gift their pets to others. those with active lifestyles and viable social connections were not ideal candidates for social robots and frequently requested greater interactivity and functionality of the pets. these results suggest that socially connected individuals with the capability of enjoying an active lifestyle outside of their home would benefit the least from robotic pets with limited features. conversely, certain subgroups reported deriving significant benefit from their robotic pet. subjectively lonely older adults with fewer perceived social connections, especially those living alone and homebound, were most often among those who integrated the pet into their daily schedule, regularly communicated with the pet, and described experiencing comfort and companionship pet interactions. further, those who experienced the death of a pet or spouse also derived companionship from their pet. interventions using social robots with limited features may be most appropriate for these subgroups. these findings identify ideal subgroups of older adults who are more likely to benefit from the use of social robots. however, the collection of these data and the resulting findings should be properly contextualized as occurring prior to the advent of the covid-19 pandemic. older adults face a higher risk of severe illness from covid-19, with individuals aged 85 or older at the greatest risk. while practicing physical distancing contributes to efforts to flatten the curve, older adults may experience increased anxiety and depression as a result of limited travel and being restricted to their homes. a recent survey found the prevalence of psychological distress in a sample of adults in united states was higher in 2020 during the covid-19 pandemic (mcginty et al., 2020) . given new constraints related to physical distancing and their potential contribution to social isolation, future studies should examine what appeal and/or effect social robots may have for previously active, socially connected adults under quarantine. similarly, future studies should examine how the use of social robots may potentially mitigate psychological distress for older adults quarantined in care centers and not permitted faceto-face visits from loved ones. these study findings provide insights into the potential benefit of robotic pets for community-dwelling older adults interacting with the pets in their own homes, and demonstrate the need to explore applicability during pandemic conditions. participant feedback yields supporting evidence demonstrating that robotic pet use may positively influence older adults' perceived loneliness and mental and emotional health, particularly for isolated and subjectively lonely community-dwelling older adults. furthermore, participant feedback potentially supports the notion that a robotic pet intervention may successfully meet two of the four points of criterion for assessing the efficacy of loneliness-reducing interventions (cacioppo et al., 2015) in this instance: improving social contact and enhancing social skills. it should be noted that these findings are consistent across gender, as compared to previous studies disproportionately compromised of female participants. given the variability of use and preferences among older adults, subsequent studies should include healthy older adults in the ongoing development of robotic pets (frennert and östlund, 2014) . this study did not directly capture interactions between participants and their robotic pets, instead relying on participants' recall; thus discrepancies in actual versus reported interactions could exist. future research with communitydwelling older adults should consider the use of animatronic pets equipped with sensors that more objectively measure interaction and travel. this cross-sectional study provides valuable insight about potential benefits experienced immediately after participants' initial introduction to the pet. longitudinal analyses are needed to understand how the findings of this study bear out over the long term, and whether mitigation of subjective loneliness among socially isolated participants bears out over time. while lonely and socially isolated older adults may derive benefit from the use of their pet, less is known about community-dwelling older adults' concurrent attempts to continue socializing with others. potential ethical issue may arise for lonely older adults who become dependent on their companion pet for companionship or social connection. participants who agreed to participate had higher levels of depression, suggesting a potential oversampling of this population. given participants may have been motivated by a desire for increased social contact and companionship, participant feedback may not be representative of a randomly chosen sample of older adults. further, favorable impressions of the pet may be overrepresented in this sample. finally, it should be noted that participants in this study were gifted their robotic pet. while the manufacturer's offerings include models at varying price points, the cost of obtaining a pet may be a barrier for some older adults. robotic pets may provide benefit for older adults experiencing subjective loneliness and perceived social isolation by providing comfort, companionship, facilitating new social connections, and serving as a proxy for a conversational partner. however, robotic pets with limited functionality may fail to address the needs of active older adult users. participant feedback suggests that robotic pets may yield the most benefit for subjectively lonely older adults living alone with fewer connections and subjectively lonely adults experiencing the loss of a spouse or pet. these findings can inform future development and production of robotic pets to accommodate the varying needs and preferences of community-dwelling older adults. existing robotic models should explore ways of improving realism and the capacity of interactive play with their owners, and accommodate older adults as active, engaged users of technology. future interventions intended to reduce loneliness may consider implementing use of robotic pets with increased interactivity. finally, future studies should examine the potential efficacy of robotic pets in alleviating psychological distress for quarantined older adults with varying connectedness. this work was funded by the supplemental health insurance program. all authors are employed or contracted by unitedhealth group or asi services, inc. however, their compensation was not dependent upon the results obtained in this research, and the investigators retained full independence in the conduct of this research. joy for all companion pets loneliness and social connections: a national 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loneliness among older adult primary care patients who live alone living with seal robots-its sociopsychological and physiological influences on the elderly at a care house none declared. key: cord-332173-m38sr6oc authors: denburg, avram e.; ungar, wendy j.; chen, shiyi; hurley, jeremiah; abelson, julia title: does moral reasoning influence public values for health care priority setting?: a population-based randomized stated preference survey date: 2020-05-13 journal: health policy doi: 10.1016/j.healthpol.2020.04.007 sha: doc_id: 332173 cord_uid: m38sr6oc objective: preferences of members of the public are recognized as important inputs into health care priority-setting, though knowledge of such preferences is scant. we sought to generate evidence of public preferences related to healthcare resource allocation among adults and children. methods: we conducted an experimental stated preference survey in a national sample of canadian adults. preferences were elicited across a range of scenarios and scored on a visual analogue scale. intervention group participants were randomized to a moral reasoning exercise prior to each choice task. the main outcomes were the differences in mean preference scores by group, scenario, and demographics. results: our results demonstrate a consistent preference by participants to allocate scarce health system resources to children. exposure to the moral reasoning exercise weakened but did not eliminate this preference. younger respondent age and parenthood were associated with greater preference for children. the top principles guiding participants’ allocative decisions were treat equally, relieve suffering, and rescue those at risk of dying. conclusions: our study affirms the relevance of age in public preferences for the allocation of scarce health care resources, demonstrating a significant preference by participants to allocate healthcare resources to children. however, this preference diminishes when challenged by exposure to a range of moral principles, revealing a strong public endorsement of equality of access. definitions of value in healthcare based on clinical benefit and cost-effectiveness may exclude moral considerations that the public values, such as equality and humanitarianism, highlighting opportunities to enrich healthcare priority-setting through public engagement. faced with both scarce resources and pressures to keep pace with innovation, health systems in most developed nations emphasize the comparative value of health interventions in payment policies and coverage decisions [1, 2] . such appraisals of value rely on assessments of clinical efficacy, economic efficiency and, increasingly, societal values. growing recognition that democratic commitments warrant more room for public voice in health and social policy decisions particularly when allocating public resourceshas spurred attempts to incorporate citizens' values and preferences in health technology assessment (hta) in an increasing number of developed countries [3] . while approaches to measuring clinical and economic value are wellspecified, the means of identifying and assimilating relevant societal values in hta are not [4, 5] . to bridge this gap, a growing academic literature has sought to address the measurement and interpretation of societal value judgements for health system priority setting. two contrasting approaches to the elicitation of societal values have prevailed: population-based surveys and exercises in deliberative engagement. both admit of strengths and limitations. while survey methods are able to elicit preferences from a large swath of the public, they often preclude in-depth reflection and discussion about the complex ethical issues involved in setting priorities [5, 6] . by contrast, deliberative engagement with patients or publics offers rich opportunities for nuanced and recursive consideration of the values that motivate allocative decisions, but from the bounded perspective of a small and select group of persons [7] . a few attempts have been made to marry deliberative and survey methods, either by bookending deliberative events with survey questions or by embedding opportunities for deliberation within survey designs [8] [9] [10] . we adapt an approach to the latter to investigate societal preferences for allocating health care resources to children as compared to adults. age represents one of the most prominent issues explored in the literature on social values for health system resource allocation [11] [12] [13] [14] [15] [16] . the focus on age stems in part from the utilitarian assumptions that anchor prevailing methods of health economic evaluation [17, 18] . qualityadjusted life years (qalys) have played a dominant role in assessing the value of health interventions, as a universal metric for comparisons of benefit among different technologies that incorporate quantity and quality of life into a unified indicator. closely allied to the use of qalys as an outcome measure in applied health economic evaluation is the assumption of utilitarian qaly maximization as a normative goaland thus decision-criterionwhen selecting the best alternative among competing interventions [19] . the prominence of qaly maximization as a decision-criterion in applied health economic evaluation, including by hta institutions internationally, has prompted theoretical and empirical inquiry into the strength of societal preference for qaly maximization [20] [21] [22] [23] . moral philosophers and social choice theorists have challenged the moral legitimacy of purely consequentialist approaches to health care rationing, including qaly maximization, citing the relevance of ethical concepts ranging from distributive justice, priority to the worst off, and rightsbased entitlements in health resource allocation [24] [25] [26] [27] [28] [29] . empirical studies of public preferences for health care resource allocation often employ recipient age as a proxy for qaly gains. studies of public preferences have yielded considerable evidence favouring priority to younger populations [13] [14] [15] [16] . such studies have often compared adults of various ages; select studies include a childhood age range among their comparators (15, (30) (31) (32) (33) . however, few studies have explored public preferences for health resource allocation decisions related to children as such. underlying societal preferences for health resource allocation: 1) 'health maximization ageism' (constant relative value of life-years, irrespective of age); 2) 'productivity ageism' (higher value of life-years in young adulthood, related to greater social and economic productivity); and 3) 'fair innings ageism' (emphasis on opportunity for equal aggregate lifetime health (or qalys) through priority to those expected to experience less, such as the young or disadvantaged) (16) . each of these approaches is outcome-oriented and concerned with health gains, though calibrated to prioritize different groups based on alternative ethical arguments. 'health maximization ageism', which corresponds to pure qaly maximization, receives its strongest support in age-based stated preference studies that focus on life-saving interventions, or those that result in more aggregate qalys for younger recipients. even so, evidence for societal disavowal of pure qaly maximization exists, with some studies yielding majority preferences for equal allocation in the face of discrepant potential qaly gains across age groups (17, 33) . importantly, studies that test preferences for age-based allocation in terms of qaly maximization alone cannot discern whether distinct moral principles inducing priority to the young (be it children or younger adults) are at play. when controlling for qalys gained, the evidence in support of priority to younger groups is mixed. stated preferences consistent with both 'fair innings ageism' and 'productivity ageism' are evident in select studies examining age-based trade-offs in the context of fixed benefits. when the duration of benefit across age groups is standardizedthereby in effect neutralizing 'health maximization ageism', or pure qaly maximizationconsistent prioritization by age breaks down, with participants alternately preferring allocation to children, people in middle age, or equal allocation across age groups (15) (16) 30, (34) (35) . it is, however, often difficult to disentangle evidence in support of one of these forms of ageism from the other in the extant literature. in addition to studies of age-based priority setting that focus on health outcomes, a number of studies explore the moral bases for allocative decision-making by examining the relevance of causes. anand and wailoo demonstrate weak societal preference for consequentialist rationing rules, including qaly maximization, through experimental rationing decisions that force tradeoffs between hypothetical adult recipients of different ages (17) . notably, they also empirically examine the relevance of deontological considerations in health care rationing, including personal responsibility for one's health state, socioeconomic status, and procedural considerations in priority setting. their work demonstrates a disavowal by participants of pure qaly maximization, and highlights other salient normative considerations for potential incorporation into rationing exercises, including equality of treatment, individual rights and duties, and procedural fairness (17, 36) . relatedly, a limited body of evidence points to the impact of embedded moral reasoning on attenuated public preference for the young, suggesting that deliberation on a range of ethical principles can influence stated preferences for allocating resources based on age (10) . however, this evidence pertains to age variations amongst adults. j o u r n a l p r e -p r o o f despite this focus on age as a morally relevant variable, the extant literature contains little dedicated inquiry into allocative preferences regarding children per se (37) . this lack of evidence has contributed to a vacuum of both theoretical and context-specific knowledge about societal preferences related to the prioritization of health system resources for children. the need for more and better knowledge of public values attached to health care priority-setting affecting children is underscored by inherent challenges associated with the assessment of child health technologies [38] [39] [40] . health system funding decisions for children are often constrained by limited evidence for the clinical efficacy or economic efficiency of child health technologies [41] . childhood diseases are typically rare, the conduct of research in pediatric populations is complex, and standard metrics of clinical and economic assessment fail to incorporate unique dimensions of childhood, such as family context and life-course impacts [1, 42] to better understand societal values for health resource allocation, we conducted a population-based stated preference survey with a nested randomized controlled moral reasoning intervention. our objective was to generate evidence to inform economic evaluation and policymaking on health care priority-setting and payment reform in developed health systems. uniquely, we sought to explicitly assess societal preferences for allocation to children, and to test j o u r n a l p r e -p r o o f the influence of structured deliberationin the form of an individual-level moral reasoning exerciseon allocative preferences. our principal aims were to: (1) understand the direction and strength of public preferences for health resource allocation between children and adults for varied treatment scenarios, (2) assess the impact of a moral reasoning intervention on the expression of such preferences, and (3) identify sociodemographic factors that impact the expression of public preferences on health resource allocation between children and adults. we also sought to test the divergence of participant preferences for children or adults from an assumption of age-neutrality, to understand the treatment scenarios within which significant preferences for either children or adults emerge. finally, we aimed to characterize the principles that most influenced participants' allocative decisions, to gain a deeper understanding of the moral reasoning behind societal preferences for health resource allocation. in keeping with much of the prior literature on age-based resource allocation, we expected that control group participants would display an aggregate mean preference for allocation to children, particularly in scenarios where theoretical qaly gains were largest (i.e. cancer treatment and eating disorders therapy). in scenarios with fixed and equal life-year gains across children and adults (i.e. chronic disease drug, liver transplant), we hypothesized that participant preferences for children would be less pronounced, but persist on average, due to intuitive conceptions of 'fair innings'. we included a palliative care scenario to test the direction and strength of age-based preferences in a context focused on relief of suffering rather than hypothetical qaly gains, anticipating weak or no preference for allocation to children. in terms of participant sociodemographics, we presumed that younger adults and those with children of their own would j o u r n a l p r e -p r o o f preferentially favour allocation to children, due to temporal and emotional proximity to childhood states. in contrast to prior evidence demonstrating diminished preference for younger adults induced through moral deliberation [10] , we hypothesized that a moral reasoning exercise would increase the strength of public preference for allocation to children, as compared to adults. this hypothesis was predicated on insights from foregoing normative analyses of public policies for children, which have identified distinguishing characteristics of childhoodsuch as vulnerability, dependency, rarity, social distinction, and future potentialas drivers for policy development [43] [44] [45] [46] [47] [48] . we postulated that the moral reasoning exercise, which incorporated a number of valuesbased considerations specific to children, would prompt participants to consider their allocative preferences in light of these unique concerns. given the ethical tools to unpack intuitions about what children might deserve relative to adults, we anticipated that participants randomized to the moral reasoning arm would apprehend justifications for preferential allocation to children that may not be immediately apparent. we further hypothesized that participants in the intervention arm would display stronger aggregate preference for children across all the clinical scenarios tested, regardless of the duration of life years gained, as a result of their access to a varied palette of ethical principles by which to justify preferential allocation to children, including vulnerability, dependency, potential, and social distinction. we conducted a population-based stated preference survey of societal views on the prioritization of health resources among children and adults, administered to a non-probability sample of j o u r n a l p r e -p r o o f canadian adults. participants were recruited through letters of invitation emailed to a random sample from a panel of over one million canadians maintained by a survey research firm. a limitation of non-probability sampling is the absence of general statistical theory to predict sample representativeness from survey design assumptions [49] . to minimize sampling bias and maximize the potential for national population representativeness, we employed interlocking quotas for stratified sampling (age, gender and region), balanced against statistics canada norms, and evaluated the composition of our final sample in comparison to the canadian population on a range of sociodemographic characteristics. the survey was web-based and loyalty program rewards were offered to encourage participation. development of the survey instrument drew on prior literature on the ethics of health resource allocation and social values relevant to child health policy. the principles included in our moral reasoning exercise were derived from a systematic review of the literature on social values relevant to child health and social policy, refined through an in-depth qualitative case study of health technology assessment and policymaking for children in canada [47, 48] . iterative refinements to the survey were informed by a pilot phase with experts (n=3) and laypersons (n=2) and field testing with members of the public (n=32). the final survey questionnaire directed respondents to assign numerical preference scores for the allocation of resources in different health care scenarios based on age-related criteria. it presented each participant with the same five hypothetical treatment scenarios (chronic blood disease, liver transplant, cancer therapy, palliative care, and eating disorder); these scenarios were intended to provide variation in disease characteristics such as acuity, morbidity, mortality, potential for cure, and nature of participants chose between funding for treatment among adult (average age 40) and child (average age 10) patients, from the perspective of a citizen advisor to a health system administrator. preferences were captured as continuous variables on a visual analog scale (vas) from -5 (full preference for children) to +5 (full preference for adults), with zero representing neutrality. we employed a vas design to explore changes in the strength of participant preferences for children or adults in order to capture more subtle variation in preference than would have been possible with categorical choices, while still allowing for preference neutrality. demographic data related to age, sex, income, education, employment, health status, and family structure were collected. randomization of participants to either an intervention or control group was achieved via a leastfill approach, employing computational logic to assign respondents to the group with the lowest current quota count, which enabled random assignment with respect to stratification variables (age, gender, region). we subjected participants in the intervention group to a moral reasoning exercise prior to each choice scenario. the exercise presented subjects in the intervention group with a list of twelve ethical principles relevant to allocative decisions ( figure 2 ). we fashioned principles to capture concepts identified as uniquely germane to health resource allocation involving adults and children, including 'fair innings', vulnerability, dependency, future potential, and distinction, as derived from a foregoing systematic review of social values relevant to health and social policy for children [47] . balance was sought between principles that might inherently favour allocation to either children or adults. participants in the intervention arm were j o u r n a l p r e -p r o o f asked to select the three principles that most influenced their choice in each scenario. subjects in the control arm responded to the choice scenarios without exposure to a moral reasoning exercise. to minimize question order bias, we randomly rotated the order by which health care scenarios were presented to participants; in addition, we randomly rotated the order of principles within the moral reasoning exercise for the intervention cohort. participants were prevented from revising their prior responses as they proceeded through the questionnaire. quantitative survey data were imported into sas (version 9.4) for analysis. descriptive statistics were employed to characterize the respondent population and compare groups using the student's t-test for continuous variables (age) and chi-squared for categorical variables. we compared select sociodemographic variables from the overall sample with general canadian population demographics from the 2016 statistics canada census of population using onesample proportion tests [50] . we employed a linear mixed-effects random intercept model, which allows for modelling of correlated continuous data, to analyze the strength of participant preferences for each of the scenarios presented and examine the impact of experimental group, scenario, and sociodemographic variables on mean preferences scores, while accounting for the correlation between repeated measures within the same subject. the model examined: 1) the difference in mean preference scores by group, scenario, and demographic characteristics and 2) the difference in mean preference scores between the intervention and control for each scenario. we analyzed the interaction of group and scenario on preference scores to understand whether group mean preference scores varied by scenario type, controlling for covariates (including age, geographic j o u r n a l p r e -p r o o f region, gender, language, education, employment, income, health, and family structure) (emethods). to further characterize the strength of participant preferences for children or adults, and explore potential choice uncertainty, we analyzed the proportions of respondents displaying any allocative preference beyond the bounds of a 'neutral' construct (zero midpoint), and modelled differences in neutral versus preferential responses as a binary outcome between groups and across scenarios through generalized estimation equation (gee) modelling. odds ratios with 95% confidence limits were computed to indicate the likelihood of a neutral response for each scenario, using chronic disease as the reference scenario. gee was also used to assess the likelihood of a neutral response by experimental group in each scenario, with moral reasoning as the exposure. lastly, we quantified the proportion of respondents selecting each allocation principle overall and by scenario. we tested equality of proportions across scenarios to detect significant differences in the proportions of respondents selecting a given allocative principle. chi-squared analyses were used to compare the proportions of participants selecting each moral reasoning principle in a given scenario, using one scenario (chronic disease) as a referent. mcmaster university. informed consent was obtained online as part of the survey panel opt-in process prior to individual survey initiation. the authors received no funding related to study design; collection, analysis, and interpretation of data; the writing of the report; or the decision to submit for publication. between april 18 and 24, 2017, a total of 12,803 individuals were screened for inclusion: 10,026 were deemed ineligible or declined to participate and 2,777 individuals were randomized. of these, we excluded 1,048 for incomplete surveys. a total of 1,729 (62.3%) respondents completed the survey; 173 were subsequently excluded for poor quality (e.g., racing). our final sample included 1,556 participants, with 773 in the intervention group and 783 in the control group (efigure 1). respondent characteristics were similar across groups (etable 1). as compared with 2016 canadian population census data, our sample evinced an overrepresentation of individuals with higher educational attainment. we present our results in sequence corresponding to the hypotheses listed above. we begin with an exposition of control group results, to ascertain whether a baseline predilection for allocation to children was apparent in our sample, and how it varied across disease-specific scenarios. we then move to analysis of mean preference scores in the intervention group, and observed differences between the intervention and control group, to isolate the impact of the moral reasoning exercise on participant preferences. our analysis of preference divergence from an age-neutral construct (-0.5 to +0.5) follows, to test the strength of allocative preference in either direction. finally, we analyze participant choices about the moral principles guiding their allocative preferences, focusing on the frequency and patterning of principle selection across scenarios. allocative preferences analysis of mean preference scores demonstrated a consistent aggregate preference by control group participants to allocate scarce health system resources to children across all trial scenarios ( figure 3 ; table 1 ). the strongest control group preference for children was observed in the cancer therapy (-1.77, 95% ci -2.06 to -1.48, p<0.0001) and eating disorders treatment (-2.01, 95% ci -2.30 to -1.71, p<0.0001) scenarios, in which the theoretical qaly gains were largest. mean scores were statistically significantly higher (more positive) in the intervention group overall, suggesting a weaker preference for allocation to children in those subjected to the moral reasoning exercise (figure 3 ; table 1 ). in the intervention group, a significant preference for allocation to children was retained in the cancer therapy (-0.83, 95% ci -1.11 to -0.54, p<0.0001) and eating disorder treatment (-1.11, 95% ci -1.39 to -0.82, p<0.0001) scenarios, but there was no age preference in the chronic disease drug, liver transplant and palliative care scenarios ( table 2) . when analyzing the difference in mean preference scores between experimental groups for each scenario, the intervention had the largest absolute impact for the cancer therapy (0.94, 95% ci where the benefits of an intervention were most obvious and different between adults and childrenas they were in respect of life-years gained from cancer and eating disorders therapy -j o u r n a l p r e -p r o o f a choice to prioritize those benefitting most may have seemed easiest, even in the face of exposure to competing moral principles. this explanation is supported by theories of rational decisionmaking from the field of cognitive psychology that posit dual-process thinking, distinguishing intuition from reasoning [51] [52] [53] . the design of our studyincluding the survey format and pacing, question framing, and lay samplemay have induced intuitive responses from some participants, in the face of complex moral problems characterized by inherent uncertainty. in particular, participants may have allowed more obvious differentiators, such as discrepant benefits in length of life, to intuitively shape their preferences, rather than take the time and cognitive effort to work through conflicting moral choices in a rule-bound manner. this is likely particularly true of those unexposed to the moral reasoning intervention, and might explain why preference score differences between the intervention and control groups were largest in respect of cancer therapy and eating disorders treatment. it may also explain why variance in preference scores narrowed consistently across scenarios in the intervention group as compared to the control group: it is possible that this reduction in variance represents a reduction in choice uncertainty, in the context of enhanced participant reliance on analytical reasoning induced by the study intervention. proportions of neutral response (score between -0.5 and +0.5) were consistently higher in the intervention group across all scenarios (etable 4). univariate gee analysis revealed the impact of the moral reasoning intervention on preference neutrality across children and adults, with neutral responses significantly more likely in the intervention group than the control group we made a conscious attempt to incorporate principles related to an array of individual and societal benefits and costs, to induce reflection on the range of moral reasons one might consider germane to health system resource allocation. we also sought balance between principles that might intrinsically engender preference for children or adults. participants exposed to the moral reasoning exercise demonstrated remarkable consistency in their prioritization of principles for allocative decision-making. the top three principles guiding participants' allocative decisions were: 1) treat equally (54.3% -63.9%), 2) relieve suffering (39.6% -66.1%), and 3) rescue those at risk of dying (37% -40.8%). in all cases except palliative care, 'treat equally' ranked number j o u r n a l p r e -p r o o f one, with a proportion uniformly greater than 50%; subjects deemed 'relieve suffering' most important (66.1%) in the context of palliative care, followed closely by 'treat equally' (63.9%). the least endorsed principles (10%) for assigning allocative preference were: priority to rare diseases, priority to special populations, and priority based on societal productivity. despite consistency in ranking of principles, the proportion of participants selecting a given principle to guide allocative decision-making varied significantly across scenarios ( table 3 ). as compared to the chronic disease treatment scenario, the cancer therapy scenario prompted significantly more participants to cleave to principles that, in theory, justify preferential allocation to children: opportunity to live a full life (24.7% vs 19.2%, p<0.0028), duration of benefit (34.5% vs 19.5%, p<0.0001), and concern for special populations (11.9% vs 7.4%, p<0.0026). they also tended to disavow principles favouring allocation to adults, including family responsibilities (14.2% vs 24.7%, p<0.0001) and economic productivity (7.9% vs 16% p<0.0001). a similar pattern was observed for the eating disorder treatment scenario, with the addition of vulnerability (36.1% vs 21.9%, p<0.0001) to the principles endorsed. by contrast, in the palliative care scenario, participants displayed significantly more concern for equality of treatment (63.9% vs 55.2%, p<0.0005) and relief of pain and suffering (66.1% vs 39.6%, p<0.0001), and less concern for 'fair innings' (the entitlement to a full lifespan) or duration of benefit. a principal finding of our study is the consistent preference for allocation to children across health care scenarios in the overall cohort. this finding is in keeping with much of the extant evidence on societal preferences for allocation to the young, but adds depth and specificity in preference in response to changes in the duration of benefit from a given intervention [16] . in the face of life-long benefits (e.g. life-saving interventions), their study participants gave consistent precedence to younger groups when allocating scarce resources. by contrast, when juxtaposed with life-long benefits, fixed benefits induced a preference pattern that privileged young to middle adulthood. our results may indicate similar moral intuitions behind participant choices, though with the notable difference of an equal allocation option. where pure qaly maximization was possiblenamely, in the cancer therapy and eating disorders treatment scenariosparticipants seemed to adjudge the life-long benefits that would accrue to children too large to overlook. conversely, in the scenarios with fixed benefits, preference for allocation to children was weaker in the control group, and a trend toward preference for equal allocation j o u r n a l p r e -p r o o f emerged in the intervention cohort. an alternative explanation could be that participants perceived scenario-specific differences in duration of benefit more readily than other benefits that, though not explicitly mentioned, also retain moral relevance in the context of these and similar scenarios. such benefits could include reduction in inequality of outcomesfor instance, founded on inherent characteristics of the disease (rarity) or population (vulnerability, dependency)or equitable chances to live a full life ('fair innings') [54] [55] [56] [57] [58] [59] . interestingly, our results at once confirm and challenge prior evidence that suggests decision-making from an impersonal vantage point (e.g. a budgetary decision-maker) makes it easier to discriminate in favour of one group as against another. nord et al. elicited allocative preferences from study participants within two different assumed perspectives: a 'veil of ignorance', in which the participants themselves might need the health intervention in question one day; and a health system administrator role, in which they were tasked with decisions about resource allocation to others from a budgetary standpoint [15] . they found that the tendency to privilege younger people in allocative decisions was more evident amongst those who assumed the latter perspective, and argued that the degree of emotional remove induced by the shift in perspective might account for this difference. evidence from our study for the moderating effect of a moral reasoning exercise on participant preferences for allocation to children, from an administrative perspective, suggests the opportunity for ethical reflection mitigated participant willingness to discriminate between groups on the basis of age. this may reflect choice uncertainty and a resultant instinct for preference neutrality, rather than evidence of real, rich moral deliberation. alternatively, this may represent a 'depersonalizing' effect of moral deliberation on allocative decision-making, one sufficient to impact societal preferences for health resource allocationbut in the opposite direction to that observed by nord et al. counter to our hypothesis, exposure to a moral reasoning intervention diminished participant preferences for allocation to children. evidence of a moderating effect of moral reasoning on allocative preference for children suggests the opportunity for ethical reflection mitigated participant willingness to discriminate between groups on the basis of age. this relationship may have been driven by a more varied set of ethical principles with which to draw conclusions. interestingly, this is the same consideration that motivated our hypothesis of increased preference for children through moral reasoning. we presumed that the ethical nuances attached to funding health interventions for childrenincluding distinguishing features such as vulnerability, dependency, neglect, and future potential, that stood out in prior normative analyses of child health and social policywould come through more clearly to participants when exposed to a range of principles touching on them [43] [44] [45] [46] [47] [54] [55] [56] [57] [58] . notably, the strength of preference for equal allocation increased among those randomized to the moral reasoning exercise. one interpretation of this is that the intervention prompted participants to evaluate the relationship between their moral intuitions and their stated preferences, and induced a reasoned judgment about the importance of equality as a guiding principle for resource allocation. an alternative explanation is that, despite the study intervention, it remained cognitively difficult for participants to reason through the uncertainty inherent in weighing competing moral principles. the greater predilection for neutrality in the experimental group may have represented retreat to equality in the face of difficult choices. our study admits of potential limitations. in relation to the survey instrument, the brief statements used to evoke the meaning of each principle may have failed to capture its ethical nuances. different framing of the principles may have led to different patterns of preference among participants; however, randomly varying the sequence of principles mitigated any ordering effect bias [60, 61] . use of a continuous scale overlapping zero to measure the strength of allocative preferences in the context of a binary choice task (fund either intervention a or b) may have led some participants to misinterpret zero as a choice to allocate equal sums of money to each population, rather than agnosticism about which intervention to fund. we sought to mitigate this potential limitation through simple, explicit scenario instructions; however, it is possible that misapprehension of the 'neutrality of preference' state by some participants impacted our results. the study was not designed to measure the time it took to read the principles in the moral reasoning intervention separately from completing the choice tasks. this could have given a proxy sense of whether participants read and engaged with the ethical ideas and choices involved. the assembly and composition of our study sample may have also limited the external validity of our results. values endorsed by the canadian public may not reflect those of other polities. the use of covariate-adaptive randomization to form balanced treatment groups with respect to relevant covariates has both benefits and inherent shortcomings; use of stratified randomization may have permitted some selection bias and only balanced a limited number of potentially relevant covariates [62] . more specifically, the survey firm generated cohorts from an opt-in panel of eligible canadians recruited and incentivized through brand loyalty points programs. some of the inherent selection bias associated with online opt-in panels was evident, privileging those with higher education who are web literate. however, the lack of statistically significant impacts of education and income on preference scores in the multivariate model attenuates theoretical concerns about sociodemographic bias. our study also has important strengths. it is, to our knowledge, the first to experimentally examine the values behind health and social policy decisions about children, their valence in relation to adult needs and priorities, and their stability in the face of moral deliberation. its randomized design and large, heterogeneous population-based sample allowed for robust conclusions about the effect of the intervention on participant preferences. our findings demonstrate a convincing relationship between exposure to a range of relevant moral principles and the priorities set. this affirms the complexity of such decisions and the impact of ethical deliberation on them. these findings challenge reflexive trust in survey-based preference elicitation, and imply the need to complement such modalities with deliberative modes of public engagement on questions of social importance, such as the allocation of scarce public resources. in policy terms, our work both supports and challenges conceptions of value in health care based primarily on qaly maximization. dominant modes of health economic evaluation privilege interventions that maximize aggregate individual and societal utility, typically in the form of the duration and magnitude of benefits reaped and the size of the population reached. our results demonstrate a stronger preference for children in the hypothetical scenarios (cancer and eating disorders) in which the duration of benefit accrued mainly to children; this may represent an underlying motivation by participants to maximize benefits. however, we also observed a strong inclination for equality and humanitarianism amongst study participants, regardless of experimental group. the three principles deemed most salient to priority-setting were equal treatment, relief of suffering, and rule of rescue. none of these prioritizes age as a relevant variable; each starts from a belief in the intrinsic value of all human life, and resists grading that j o u r n a l p r e -p r o o f value by social context or circumstance. our results, therefore, suggest the need to incorporate other values into health care priority-setting, as some value frameworks for funding decisions have begun to do [63] . the salience of these findings to priority-setting efforts in the context of public health emergenciesincluding access to scarce ventilators or drugs in the context of the covid-19 pandemicis readily apparent. they furnish empirical evidence for the adjudication and refinement of ethical frameworks for triage and resource allocation during the pandemic based on public values in canada [64, 65] . efforts to incorporate a broader range of public values and preferences in health and social policy decisions also involve inherent risks. among them is the need to confront and grapple with public attitudes that conflict with the fundamental normative or legal principles that structure most democratic societies, including basic commitments to the protection of individual rights and nondiscrimination [66] . future research to explore this tension and ways to resolve or address it is warranted. allied to this, our study affirms the importance of process in health care priority-setting exercises. the opportunity to explicitly consider varied normative ideas appears crucial to informed allocative decisions based on public values. the observed changes in public preferences in the face of competing moral principles imply the impact, and potential relevance, of structured opportunities for moral reasoning when making such consequential decisions. this includes the potential value of deliberative public engagement to health policymaking, particularly in domains where distinct ideas about the public good may compete. specific to children, few efforts to incorporate public deliberation in research and policy on child health and social policy priorities have prevailed to date. in the face of resource scarcity, evidence-informed child health and social policies will depend on the careful elicitation and integration of public values. this and allied work bear potential relevance in social policy domains beyond health, including public attitudes to j o u r n a l p r e -p r o o f 'deservingness' attached to welfare state distributional policies in domains as diverse as labour markets and education [67] [68] [69] [70] [71] [72] [73] . crucial future areas of inquiry and application include the inclusion of child voices in research and policymaking, and the exploration of social values for priority setting within public policies and programs for children. our study underscores the relevance of age in public preferences for the allocation of scarce health care resources, extending evidence of this calculus to trade-offs involving children. nevertheless, it demonstrates the mutability of such preferences in the face of structured moral deliberation. this finding has three main repercussions. it furnishes a critical lens for the interpretation of stated preference surveys; introduces a note of caution into dominant modes of health care funding allocation decisions premised on utility maximization; and implies the value of deliberative methods as a complement to both. we observed a strong inclination for equality and humanitarianism amongst study participants, regardless of experimental group. these moral impulses prevailed over consequentialist logic, including priority to the young founded on aggregate benefit. the stability of these principles in the face of changing allocative preferences signals their importance as public valuesbut it also hints at the complexity of values-based decision-making. the public seems, at face value, to believe in equality of access and defend a set of shared human entitlements to care. it also seems to assign intuitive priority to children. the challenge of reconciling these convictions demands processes nimble enough to negotiate this paradox. spaces for moral deliberationwhether in large-scale surveys or focused qualitative engagementare essential to arrive at health care priorities that reflect what we collectively hold dear. j o u r n a l p r e -p r o o f contributions: ad conceived and designed the study. sc and ad performed the statistical analysis. ad prepared the first draft of the manuscript. all authors contributed to study design, critically revised the manuscript, and approved the final version. as corresponding author, ad accepts responsibility for the work, had full access to the data, and controlled the decision to publish. ad attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted. acknowledgements: during the period of this research, ad was supported by grants from the canadian institutes of health research, pierre elliott trudeau foundation, canadian child health clinician scientist program, and pediatric oncology group of ontario. imagine that two different medicines are available to manage an incurable chronic blood disease: one drug treats the child form of the disease, while a different drug treats the adult form of the disease. without treatment, patients die of the disease within 6 months of diagnosis. with drug treatment, both child and adult patients can be expected to live about 20 years from diagnosis, after which they usually die from progressive complications of the disease. each drug costs the same amount of money and would serve the same number of people. the health system can only afford to fund one of the two drugs at present, and cannot split the money between the two drugs. please slide the bar to any point on the scale from -5 to +5 to show your strength of support for funding one of the drugs. a drug is available for patients with childonset blood disease. a drug is available for patients with adultonset blood disease. patients live about 20 years with the treatment, at which point they usually die of complications from the disease. without the drug, the disease causes death within 6 months. without the drug, the disease causes death within 6 months. fund treatment based on evidence that it works  "fund treatments best proven to be safe and effective."  "since it is harder to study treatments in children, evidence is usually stronger for adult treatments."  "the older patients have had their turn."  "give the younger patients a chance for a full life." treat people who will benefit longer  "giving the treatment to the younger group makes sense, since they will enjoy it longer."  "lifelong potential should be factored into decisions about which health interventions to fund."  "at 40, people may be raising families or have others who rely on them."  "resources should be directed to help those that cannot protect or advocate for themselves."  "children are still developing, so can suffer lifelong consequences from untreated disease." treat people who are productive  "helping people who are in the workforce has benefits for all." treat everyone equally  "all patients deserve equal access to medical care."  "both groups should have the same chance." treat those who are dependent on others  "children are dependent on their parents or caregivers, so their illness has direct impacts on the lives of others." r 2 : the full model with predictors explained 9.7% of within-subjects variance and 4.3% of between-subjects variance, as compared with the null model (without predictors). comparing the full model with a parsimonious model (non-significant predictors removed), the two models were almost identical. the parsimonious model explained 0.05% more of the between-subjects variance; there was no difference in within-subjects variance explained. details omitted for double-blind reviewing making the case for value-based payment reform in children's health care details omitted for double-blind reviewing health technology funding decisionmaking processes around the world: the same, yet different details omitted for double-blind reviewing effect of discussion and deliberation on the public's views of priority setting in health care: focus group study details omitted for double-blind reviewing democracy and deliberation considered opinions: deliberative polling in britain can a moral reasoning exercise improve response quality to surveys of healthcare priorities which of two individuals do you treat when only their ages are different and you can't treat both the utility of health at different stages in life: a quantitative approach is the valuation of a qaly gained independent of age? some empirical evidence an empirical study of the fairness of allocation of health care resources the significance of age and duration of effect in social evaluation of health care measuring people's preferences regarding ageism in health: some methodological issues and some fresh evidence utilities versus rights to publicly provided goods: arguments and evidence from health care rationing ethical and distributive considerations measurement of health state utilities for economic appraisal the social value of a qaly: raising the bar or barring the raise? qalys and ethics: a health economist's perspective qaly maximisation and people's preferences: a methodological review of the literature consequentialism and its critics rights, goals, and fairness development as freedom personal utilities and public judgements: or, what's wrong with welfare economics rational normative economics vs 'social welfare' and 'social choice the social value of health programmes: is age a relevant factor? preferences for lives, injuries, and age: a stated preference survey are some lives more valuable? an ethical preferences approach maximizing health benefits versus egalitarianism: an australian survey of health issues preferences for life saving programs: how the public discounts time and age health priorities and public preferences: the relative importance of past health experience and future health prospects the nature of procedural preferences for health-care rationing decisions should health gains by children be given the same value as health gains by adults in an economic evaluation framework? in: economic evaluation in child health details omitted for double-blind reviewing details omitted for double-blind reviewing details omitted for double-blind reviewing details omitted for double-blind reviewing the generation gap: differences between children and adults pertinent to economic evaluations of health interventions are newborns morally different from older children? social policy for children and families: a risk and resilience perspective life course health development: an integrated framework for developing health, policy, and research towards a sociology of child health details omitted for double-blind reviewing details omitted for double-blind reviewing a review of conceptual approaches and empirical evidence on probability and nonprobability sample survey research a perspective on judgment and choice -mapping bounded rationality individual differences in reasoning: implications for the rationality debate? who is rational? studies of individual differences in reasoning intergenerational equity: an exploration of the 'fair innings' argument an equity framework for health technology assessments voices for children: rhetoric and public policy values and assumptions underpinning policy for children and young people in england an evaluation framework for funding drugs for rare diseases age-related preferences and age weighting health benefits eliciting preferences for prioritizing treatment of rare diseases: the role of opportunity costs and framing effects psychology and economics a better alterative to stratified permuted block design for subject randomization in clinical trials details omitted for double-blind reviewing a framework for rationing ventilators and critical care beds during the covid-19 pandemic fair allocation of scarce medical resources in the time of covid-19 details omitted for double-blind reviewing who should get what, and why? on deservingness criteria and the conditionality of solidarity among the public the deservingness heuristic and the politics of health care the political logic of labour market reforms and popular images of target groups public support for sanctioning older unemployed-a survey experiment in 21 european countries the need for and the societal legitimacy of social investments in children and their families: critical reflections on the dutch case the role of welfare state principles and generosity in social policy programmes for public health: an international comparative study contemporary public policy influencing children and families  "when it comes to relieving suffering, other factors shouldn't count."  "we should always relieve pain when we can."we should rescue those at risk of dying  "everyone deserves the same chance of rescue from life-threatening circumstances."  "saving someone's life is important, regardless of age."treat those society considers special  "children are a distinctly valued social group that deserves privileged treatment."give priority to rare diseases  "rare diseases are often neglected, so should receive special priority."  "childhood disease are often rarer than adult ones, so might be unfairly overlooked in health system planning." key: cord-279935-asg71qtr authors: beasley, lana o.; ciciolla, lucia; jespersen, jens e.; chiaf, ashleigh l.; schmidt, mallory; shreffler, karina m.; breslin, florence j.; bakhireva, ludmila n.; sanjuan, pilar m.; stephen, julia m.; coles, claire d.; chambers, christina d.; kable, julie a.; leeman, lawrence; singer, lynn t.; zellner, jennifer; morris, amanda s.; croff, julie m. title: best practices for engaging pregnant and postpartum women at risk of substance use in longitudinal research studies: a qualitative examination of participant preferences date: 2020-10-28 journal: advers resil sci doi: 10.1007/s42844-020-00019-1 sha: doc_id: 279935 cord_uid: asg71qtr there are significant barriers in engaging pregnant and postpartum women that are considered high-risk (e.g., those experiencing substance use and/or substance use disorders (sud)) into longitudinal research studies. to improve recruitment and retention of this population in studies spanning from the prenatal period to middle childhood, it is imperative to determine ways to improve key research engagement factors. the current manuscript uses a qualitative approach to determine important factors related to recruiting, enrolling, and retaining high-risk pregnant and postpartum women. the current sample included 41 high-risk women who participated in focus groups or individual interviews. all interviews were analyzed to identify broad themes related to engaging high-risk pregnant and parenting women in a 10-year longitudinal research project. themes were organized into key engagement factors related to the following: (1) recruitment strategies, (2) enrollment, and (3) retention of high-risk pregnant and parenting women in longitudinal research studies. results indicated recruitment strategies related to ideal recruitment locations, material, and who should share research study information with high-risk participants. related to enrollment, key areas disclosed focused on enrollment decision-making, factors that create interest in joining a research project, and barriers to joining a longitudinal research study. with regard to retention, themes focused on supports needed to stay in research, barriers to staying in research, and best ways to stay in contact with high-risk participants. overall, the current qualitative data provide preliminary data that enhance the understanding of a continuum of factors that impact engagement of high-risk pregnant and postpartum women in longitudinal research with current results indicating the need to prioritize recruitment, enrollment, and retention strategies in order to effectively engage vulnerable populations in research. there are significant barriers to recruiting and retaining individuals with overlapping vulnerabilities (i.e., substance use disorders (sud)) in the pregnancy or postpartum period (davis, yao, & bierer, 2019; mchugh votaw, sugarman, & greenfield (2018) wetherington & roman, 1998) . this may result in challenges for generalizability and therein create a relatively sparse knowledge base about the long-term outcomes for these women and their children including the environmental, mental health, physiological, and neurological factors. filling these knowledge deficits and gaps requires ongoing assessment because research tools including those for recruitment and retention change; in addition, substance exposures in pregnancy change (e.g., prescription opioid exposure, cannabis use), thereby shifting methods to reach target populations of interest and methods to measure outcomes of interest. it is imperative for the field to identify and address engagement in research, to ensure representation of pregnant and postpartum women that use substances. engagement in longitudinal studies will allow a more complete understanding of maternal and child health outcomes as a result of new and emerging trends in prenatal substance exposure. enhanced understanding of participants' perspectives on engagement and study participation will allow researchers to more fully address this pressing research and public health need. prenatal exposure studies began in earnest in the 1970s, after the identification and diagnosis of fetal alcohol syndrome (jones & smith, 1973) . careful participant selection and comparison selection were and are necessary to classify effects of prenatal exposures. protectionist and paternalistic regulations (e.g., the national research act of 1974, and federal regulations designating pregnant women as a vulnerable population) excluded women from health research and limited the field's understanding about how sex and gender shape substance use and sud (davis, et al. 2019; wetherington & roman, 1998; institute of medicine, 1994; institute of medicine, 1999a) . research studies on substance exposures during pregnancy expanded rapidly in the past 30 years, in recognition of the cocaine epidemics of the 90s, and the current increases in prenatal opioid and methamphetamine exposures (gabrhelík, et al. 2020) . indeed, research that focused specifically on prenatal exposures and other women's health issues has been encouraged by journal editors, policymakers, and funding agencies including the nih helping end addiction longterm (heal) initiative. despite bioethical, legal, and social concerns regarding the risks and benefits of research participation for pregnant and postpartum women who use alcohol and drugs (davis, et al. 2019) , the inclusion of vulnerable populations who are marginalized or stigmatized in research on sensitive topics has not demonstrated undue harm or exposure to unacceptable risk, and in fact, has been associated with potential benefits, such as altruism, catharsis, and gained knowledge (alexander, pillay, & smith, 2018) . of course, it is important for researchers to adopt careful experimental design and safeguards that will uphold the principal of non-maleficence and protect vulnerable participants from harm (alexander et al., 2018; sikeweyiya & jewkes, 2013) . exclusion of substance using populations may violate important bioethical principles of human subjects research, particularly the principles of autonomy, beneficence, and justice (alexander et al., 2018) . exclusion from research not only strips individuals from making decisions about their own autonomy and denies them potential benefits of participating, but also exposes them to greater societal marginalization and may ultimately place them at increased risk of harm due to deficits in critical health knowledge and exposure to inappropriate or ineffective treatments (alexander et al., 2018; johnson et al., 2014; institute of medicine, 1999b) . unfortunately, prenatal exposures to alcohol, tobacco, and other drugs are rising (substance abuse and mental health services administration, 2018), with 1 in 4 pregnancies exposed to tobacco (18.9%), alcohol consumption (10.0%), or illicit drug use (4.7%) (ebrahim & gfroerer, 2003; havens, simmons, shannon, & hansen, 2009 ). specifically, opioid exposed pregnancies have increased from 1.5 to 6.5 per 1000 pregnancies (haight, ko, tong, bohm, & callaghan, 2018 ). yet, cannabis exposures are the most prevalent drug exposure, with nearly 7-8% reported exposure in the first trimester (alshaarawy & anthony, 2019) . rising rates of substance exposure correspond to increasing health risks and adverse outcomes at great societal cost and burden to systems of health care and social services, as well as criminal justice. notably, researchers involved in the nida-funded perinatal-20 treatment research demonstration program that focused on sud treatment for pregnant and postpartum women identified seven clinical factors that contributed to significant difficulty and complexity in the recruitment and retention of women in substance use treatment research, including as follows: (1) severity of sud, (2) legal system involvement, (3) housing instability, (4) interpersonal relationship challenges, (5) parenting responsibilities, (6) employment challenges, and (7) need for more intensive services. these difficulties with recruitment and retention contribute to additional complications for research, including biased samples of convenience recruited through referrals from social and health agencies, limited sample diversity, deviations from the research design, and ethical issues associated with risk and benefits of participation and involvement with the criminal justice or child welfare system. in particular, when research designs do not involve the possibility of direct benefit due to participation (i.e., observational versus intervention studies), it is important to understand the unique reasons and motivations that drive decision-making about research participation (hallowell et al., 2010) . due to all of the aforementioned factors that potentially inhibit the inclusion and engagement of high-risk participants (i.e., participants previously or currently using substances), it is imperative to understand the motivations for engagement in research among high-risk participants, focusing specifically on understanding motivation for research participation, factors that influence decision-making about participation, and barriers to participation. the current study reports results from a qualitative research study conducted as part of an 18-month, multi-site pilot study aimed to develop and demonstrate feasibility of an experimental design for a 10-year, prospective, longitudinal investigation of normative childhood brain development, beginning in pregnancy. a major aim of the 10-year study will be to determine factors that alter brain development including prenatal exposure to opioids and other psychoactive substances, as well as other prenatal and childhood environmental exposures. this goal necessitates recruiting pregnant women previously or currently using substances, as well as a large group of pregnant women who are at low risk of prenatal substance use. two of the primary aims of the pilot are (1) developing and testing recruitment and retention strategies and (2) addressing ethical and legal challenges of conducting research with a stigmatized and vulnerable population. the current qualitative study is one arm of the 5-site consortium to improve understanding, from a qualitative perspective, the continuum of engagement of low-and highrisk participants in research. this manuscript focuses on the results of the distinct needs and responses of high-risk participants. specifically, the objectives in this analysis were to address important factors that impact best practices in (1) promoting longitudinal research to high-risk participants, (2) enrolling high-risk participants in research, and (3) retaining high-risk participants in research studies. individual interviews and one focus group were conducted with a total of 41 women (five participated in a focus group). women were at high-risk of prenatal or postnatal substance use and were identified through medical clinics, other research study involvement, or sud treatment programs. recruitment took place across five sites in the usa located in california, georgia, new mexico, ohio, and oklahoma (see table 1 for demographic information). high-risk pregnant and postpartum women were defined in the current study as a parenting or pregnant woman who had used alcohol and tobacco and/or had a current or past history of sud. some participants were currently receiving sud treatment. contact was made through trained research personnel located at each specific site with 41 total participants taking part in the current study (california, n = 3; georgia, n = 4; new mexico, n = 9, ohio, n = 8; oklahoma, n = 17). only one focus group that included five women was combined with the individual interviews. the one focus group was conducted in new mexico prior to group restrictions imposed due to covid-19. qualitative methods for the research team, study design, and analysis followed the guidelines recommended by tong, sainsbury, and craig (2007) . qualitative study recruitment began with sites contacting participants in person or by phone and describing the current study and qualitative interview process. all women who expressed interest in participating were scheduled for either a focus group or individual interview depending on whether the interview took place prior to or following covid-19 restrictions regarding in-person gatherings. interviews conducted during the covid-19 restrictions were conducted individually by phone. all participants gave oral informed consent. during the consent process, a brief overview of the qualitative study and all safety measures taken to ensure confidentiality were discussed. trained qualitative research assistants collected all qualitative data from march 2020 through june 2020. before engaging in focus groups/individual phone interviews, all participants completed an in-person or online survey that included a demographic questionnaire and watched a short video describing the protocols planned for the larger, longitudinal study including neuroimaging (e.g., mri), neurodevelopmental, and biospecimen collection. for the focus group, snacks were provided. participants received a $50-75 incentive for their participation, and this varied based on site. all focus groups and individual interviews were audio-recorded and lasted approximately 45-60 min. transcription work was conducted by qualitative team members or a transcription company, with team members crosschecking all transcripts to verify accuracy. during the transcription process, all identifying information was removed to ensure privacy. all procedures were approved by the sirb for the 5-site consortium. focus group and individual interview guides for the current project were developed by the first author, in conjunction with the evaluation team and other sites within the research consortium reviewing and revising the guide as needed. focus group and individual interviews were coded individually and combined for data analysis. all coding and data analysis was conducted at one site. recordings were transferred securely according to irb-approved methods. it is important to note that focus group and individual data themes were examined a priori and themes were congruent and therefore data were merged. qualitative data was analyzed using the nvivo © 11 software. five qualitative researchers worked together to develop a codebook focused on broad themes influenced by the semistructured interview guide. thematic analysis was used to define specific themes within the broader categories (braun & clarke, 2014) . the codebook was developed using an agreed upon coding scheme with themes not being predetermined but rather emerging from the data. upon completion of the codebook, two teams consisting of two qualitative researchers coded all transcriptions using developed coding templates. cleaning of data took place as needed (broader codes enveloping smaller codes). once coded, inter-coder reliability was established using simple percent agreement, which is a commonly used method for assessing reliability in qualitative studies (lombard, snyder-duch, and bracken, 2006; stemler, 2004) . average inter-coder reliability was over 85%. in the "results" section, themes are described in more detail. the validity of the current research findings are enhanced by several design factors such as the calculation of salient factors using percentage of comments and the team-based approach used for coding. specifically, calculating the percentage of comments from participants related to specific themes allowed the research team to ensure that themes discussed in the current paper were saturated or were discussed frequently in focus group/individual interviews. therefore, relying on percent of comments strengthens demonstration of saturation in the current study. further, the majority of qualitative data were collected from individual interviews (n = 36) rather than a focus group (n = 5), which allows for a more in-depth conversation. specifically, during individual interviews, comments were able to be probed deeply with rich content emerging throughout the qualitative data, rather than simple agreement or disagreement that often emerges from focus group data collection. additionally, the fact that both primary researchers as well as consortium partners were involved in developing the focus group/individual interview guide is a strength, increasing the likelihood that the items on the interview guide validly and comprehensively captured the intent of the research aims. qualitative results for the current study focused on a continuum of engagement of high-risk participants in a multi-year prospective longitudinal, cohort design research study. specifically, themes were organized into key engagement factors related to the following: (1) promoting research to high-risk participants, (2) enrollment of high-risk participants in research, and (3) retention of high-risk participants in a multi-year prospective longitudinal, cohort design research study. key socioeconomic and demographic variables for the study participants are presented in table 1 . the current sample was more racially/ethnically diverse than the general us population, with most participants identifying as white (56%), followed by hispanic/latino (15%), black/african american (10%), multi-racial (10%), american indian (7%), and asian (2%). many participants reported they had never married (51%) with other participants reporting they were currently married (27%), living with a significant other (8%), or divorced (10%). many participants reported completing high school (22%) with an additional 27% reporting obtaining a ged. the average monthly income was $1470.73 per month (sd = $1978.95) and most participants reported receiving some form of government assistance (90%). best ways to promote research studies to high-risk participants participants were asked about the best ways to promote a longitudinal research study to recruit participants and their children into studies with participants explaining the best recruitment locations, ideal individuals to share research study information, and the best type of recruitment material. participants reported that social media is an ideal platform to reach participants (31% of comments). specific social media locations include facebook, instagram, and online mother groups. one participant explained, "a lot of people use social media. so, if it got posted to somebody's account, then you could share it with all of your friends. so, i think that would be great." participants also reported that medical offices (15% of comments) and community/state agencies (10% of comments) were good locations to share information about research studies. an example quote includes: and maybe … when i go to (local agency) for counseling and you know, my mental health needs for me and my kids, therapy anything like that. they always have all kinds of [information] … are you struggling with this, are you interested in this, here's a study to help you earn extra money, are you a single mom, do you have this or that, well then you may qualify for this study that we're doing. other suggested locations included bus stops (8% of comments), billboards (7% of comments), and grocery/ convenience stores (7% of comments). participants also reported that child-friendly locations (i.e., library, parks; 6% of comments) and educational settings (4% of comments) were good locations to share study information. one participant explained, "maybe flyers at childcare centers and stuff like that, where they have the younger school-aged kids from infant to whatever. i know a lot of moms frequent those places." when participants were asked about locations they would trust the most to receive information, it was disclosed that medical offices such as doctor offices/clinics, state agencies (e.g., women and children food programs, other human services), and educational settings were considered most trustworthy. participants also discussed the type of material they would recommend using to promote research studies with participants explaining they would use commercials (28% of comments), brochures (23% of comments), and radio (15% of comments) to share information about research studies. it was also reported that using news/newspapers (6% of comments), online marketing strategies (6% of comments), and sharing information through word of mouth (4% of comments) would be most effective. in terms of the individuals that would be best to share research study information, participants stated that study information would best come from medical personnel (42% of comments), friends (15% of comments), family members (13% of comments), other participants (9% of comments), and professionals (9% of comments). professionals included counselors/therapists, daycare personnel, clergy, and staff at resources centers. participants were also asked who they would find the most trustworthy in sharing information with them and disclosed doctors (57% of comments), family/other mothers (14% of comments), and friends (12% of comments) would be most trusted. an example quote regarding who participants would trust the most was: …when you think of doctors you think you can trust them more, because they're there to help you take care of your kids or take care of yourself … the doctor isn't going to try to scam you out of something so when you get information from them about a study … you tend to want to read about what they are giving you. research enrollment decision-making participants were asked if any information could be provided during recruitment to help them make the decision of whether or not to enroll in a 10-year research project that includes data collection from them and their children. the most frequent request for more information involved study procedures (45% of comments). specifically, participants wanted to know more information about data collection, including procedures related to neuroimaging such as magnetic resonance imaging (mris), biosampling, and frequency of procedures. an example quote of wanting more information on study procedures was: …looking at everything that might be required of participants, it seems kind of … a bit invasive and like kind of a large commitment in regards to [sic] coming for mris and sending blood work, the diapers, giving hair, things like that. participants also explained that they wanted to know additional information about the purpose of the study (22% of comments) with participants explaining that they wanted an explanation of the research study in its entirety and how it related to child development. another area that participants explained they needed more information about was study logistics (17% of comments) with participants explaining they would like to know the location of the study and commitment involved with being in the study. in terms of research commitment, one participant shared needing to know "… times and dates to make sure everything is scheduled right … trying to get a couple of days in at the job and … just timing stuff." participants were also asked if there was anyone they would need to speak with to make a decision about enrolling in research involving themselves and their child(ren). participants indicated they would speak to a variety of key individuals, including their significant other or the biological father of the child (52% of comments), family members (23% of comments), and medical personnel (16% of comments). participants reported that several things would make them interested in joining a research study with the most frequent being understanding the research benefits (48% of comments) to others (66% of comments) and themselves (34% of comments). an example quote regarding research benefits to others was: i think if participating contributes to information that can help other moms in the future, if there's more information that can be gained or developed out of this study that can be provided to other moms, before they get pregnant, as they're pregnant, to help in their baby's development. i feel like that's, in some part a small contribution i can make. participants also reported that for research studies that involved their children, there was a strong interest in being provided study results about their children (28% of comments). this included information on brain development and overall child development. one participant explained, "it seemed like something that would be really interesting is to find out more information about your own child …not? just brain development. that's really something that interests me." participants also reported that compensation would impact their interest in joining a research study (10% of comments) with several participants indicating that a potential increase in compensation over time would be attractive. specifically, one participant explained, "i would say maybe increase the compensation as the years go on because … it's hard to stick with a program." barriers to joining a research study participants also discussed barriers to joining a research study. participants reported that a busy schedule (35% of comments) could make it difficult to join a research study. this includes challenges regarding the time commitment for the study and also balancing their work schedule around research study demands. other barriers included transportation difficulties (32% of comments), travel time and location of the study (11% of comments), and having childcare while participating in research activities (11% of comments). many comments from participants regarding barriers were concerns about taking part in a research study. primary concerns included potential risks to the fetus/child (31% of comments) both during pregnancy and after the child is born. one participant explained, "just making sure no harm to the baby … i mean i understand the blood samples but just making sure it's 100% safe." other concerns included ensuring that participant personal and research information was kept confidential (31% of comments) as well as understanding the invasiveness of biospecimen collection (20% of comments). in terms of confidentiality, an example quote from a participant was: …a reassurance that the information would stay private and … the only thing that made me a little uncomfortable was when you were like "we will have to take your identifying information but then it will be destroyed." i feel like there might be something to substantiate that it's going to be destroyed, and not just a word of mouth thing. supports needed to stay in a research study additional advice was collected from participants regarding what would help them stay in a research study after enrollment. participants reported a variety of research supports that would be helpful to stay in a research project (31% of comments). specific research supports included providing childcare during data collection, compensation for time spent in research, and provision of transportation as needed for families. related to this theme, one participant explained that "… childcare on site is probably a huge one" and another participant reported that "transportation would be very helpful." it was also explained that specific research study logistics are important to consider in supporting participants to stay in a research study (21% of comments). these included receiving regular research updates including the benefits of the study, having well-trained research staff, research staff engaging in regular contact with participants, families being close to the research/data collection site, and families being provided advanced notice of data collection. with regard to receiving research updates, a participant explained: …getting kind of feedback about … here's what you contributed and here's what … we're gonna use … information on what we found, about your baby's development ... for me that would be important. flexibility was another key area of importance for participants (16% of comments). specifically, it was reported that flexibility of the participant schedule, when research appointments are scheduled, and who brings the child to research appointments are important to support ongoing research engagement. an example quote regarding flexibility was: so, i don't know how long an appointment would take. but if appointments could be, quick, able to work around my schedule, flexible, and maybe offer something like what we're doing now (phone interview). if we're not able to meet, like some kind of tele-health option. that would make it so much easier. participants also reported that home visits could potentially increase their ability to stay in a research study (18% of comments) as it would make visits more convenient. it is important to note that some families reported concerns with home visits indicating that not all families feel comfortable with research personnel coming into their home. another theme that emerged included the importance of becoming familiar with research staff (8% of comments) as it creates comfort in staff working with children involved in the research study. participants explained barriers to staying in a research study after enrollment with the most frequent barrier being family-related barriers (61% of comments) including work schedule, family moves, generally busy schedule, lack of childcare, and child(ren) not being interested in the study (when older). with regard to family moves, a participant shared "… it would depend on where i moved and if you guys had the same research study where i moved to." specific research study logistics (30% of comments) were also reported as a potential barrier to staying in a research project with participants explaining barriers related to transportation, time commitment, and frequency of data collection. specific to time commitment/frequency of data collection, one participant explained wanting more information on "how often do you want me to come in? how long are we gonna be there?" best ways to stay in contact with high-risk participants participants were also asked about the best way to stay in contact with participants during a longitudinal research study with participants reporting that collecting contact information from family members is recommended (26% of comments). specific to information important to collect from participants, personal information such as phone number (23% of comments), email (19% of comments), social media information (11% of comments), and home address (11% of comments) were reported as ideal. the current qualitative data describes a continuum of factors that impact engagement of high-risk participants (i.e., those currently or in the past using substances) in a 10-year complex longitudinal research study. this continuum included factors that impact research promotion strategies, enrollment, and retention of high-risk participants in research studies (see fig. 1 ). recruiting a representative sample of pregnant high-risk participants for a longitudinal study is challenging. however, considering promotion strategies, it is evident that there are a number of avenues whereby researchers may have success both finding and creating contact points with high-risk participants. our findings illustrate how the construct of research promotion is multifaceted. responses from interviews included three major factors: (1) the location where research material is shared, (2) the type of material used, and (3) the person sharing the research material all potentially impact marketing success. considering recruitment locations, participants frequently recommended social media, followed by medical offices, and community/state agencies. in regard to social media, studies have increasingly indicated social media as a key location to gain access to individuals who may be harder to reach, including high-risk individuals (betsch, 2014; frandsen, walters, & ferguson, 2014) . additionally, marketing through social media can contribute to reduced recruiting costs, shorter recruiting periods, and better population representation (maloni, przeworski, & damato, 2013; whitaker, stevelink, & fear, 2017) . social media has become increasingly common as a major component of research recruitment strategies in recent years (fusar-poli et al., 2016; whitaker, et al. 2017) . television commercials, brochures, and radio ads were the three most often recommended mediums. these more traditional marketing methods have been used in research for decades; however, barriers in the use of television and radio advertisements have become more relevant in recent years. for example, many of those who watch television have begun resorting to streaming services. these streaming services often allow users to skip ads, or even remove ads all together. additionally, online radio services with ad-free options have become increasingly common (wlömert & papies, 2016) . however, although these trends are occurring in the general population, less is known regarding how changes in television and music consumption have changed specifically for pregnant and parenting women with sud. medical personnel, family members, and friends comprised the limited sources for trusted information on research studies for participants. this suggests close interpersonal relationships are important to consider during recruitment. moreover, doctors and nurses may be successfully engaged in the recruitment process where feasible. this is consistent with research newington and metcalfe (2014) showing that forming collaborations with trusted medical professionals aided in both identifying and gaining access to eligible, hard-to-reach participants. adding to support this, when asked who they would trust the most to receive research recruitment information materials from, the most common answer among participants was doctors. the decision to enroll in a long-term research study with few or no direct benefits for participants is complex and multifaceted (hallowell et al., 2010) . for pregnant and parenting women who use drugs and/or alcohol, the decision can be further complicated by concerns about privacy and safety, logistics related to participation, and details about study procedures and how they relate to child development. the interview and focus group responses from our participants indicated that comprehensive information about specific study procedures and the purpose of the study was most important for informing research participation, with particular interest in understanding the commitment and burden (i.e., time, effort) associated with participation. additionally, almost a third of participants reported concerns about safety and invasiveness of study procedures, particularly the risks to their child, as well as concerns about confidentiality and maintaining the privacy of their personal information. in addition to the concerns about privacy, participants expressed a desire for reassurance that they could trust the research team, and to that end, it was fig. 1 recruitment, enrollment and retention strategies of high-risk participants in research important that study procedures were clearly explained so that they could weigh the risks of participating with potential benefits. this speaks to the importance of autonomy in decisionmaking and informed consent practices, whereby participants' ability to weigh the costs and (potential) benefits of participation and to make the decision for themselves should be valued and respected (alexander et al., 2018) . interestingly, when participants were asked about factors that would influence motivation to participate in nontherapeutic research, a number of participants spoke about understanding the perceived benefits for others as well as for themselves. consistent with previous research showing that altruism was a key motivator for research participation (alexander et al., 2018; hallowell et al., 2010) , current participants indicated that "helping other moms in the future" was an important factor in driving motivation. specifically, participants explained that related to others, they wanted to know more about how research knowledge could support other participants and children as well as how physicians could support young children and families. although altruism has been associated with positive health benefits (post, 2005) , the indirect benefits of charitable helping, such as positive mood and enhanced meaning, can be difficult to articulate and capture, especially when the help provided does not have a clearly defined beneficiary or observable impact (i.e., helping an unknown other, sikeweyiya & jewkes, 2013) . notably, altruistic motivation was more likely to occur among participants who were better informed about research generally and what might be gained through research participation at the level of the community or society more broadly (sikeweyiya & jewkes, 2013) . these findings suggest that altruism is a motivating factor that could be more directly addressed in marketing and informed consent processes, with additional information provided to potential participants about the value of research participation more generally, as well as how participants' specific data will help others, as much as it can be known or anticipated. direct compensation for participating was also identified as an important factor in deciding whether to participate in research. the decision to participate in research is shaped by personal situations and life factors, in particular, money and time. even among participants who reported altruism as a motivating factor, many expected a mutually beneficial interaction that both contributed to the betterment of society and compensated them directly (owen-smith et al., 2016; sikeweyiya & jewkes, 2013) . previous research has shown that participants who are older or have financial hardship were more likely to expect a direct material compensation for participation (sikeweyiya & jewkes, 2013) . if the real costs of study participation are not covered, then study participation can add to an already financially burdened household. in attempting to recruit high-risk or vulnerable populations into research, it is important to consider material compensation as both a motivating factor and a factor that reduces barriers to participation in the context of socioeconomic hardship without introducing undue coercion. a number of participants spoke of concerns about balancing research participation around their work schedules, as well as the costs associated with participation in terms of time, transportation, and childcare. thus, consistent with previous research with vulnerable populations (owen-smith et al., 2016) , compensation that adequately compensates time (especially if any work needs to be missed or childcare must be obtained), effort, and inconvenience is an important factor for motivating enrollment, with special attention given to unique participant needs and preferences regarding type of incentive (george, duran, & norris, 2014; owen-smith et al., 2016) . transportation has also been identified as a barrier in multiple studies involving high-risk families (e.g., mendez, 2010) , and providing transportation is necessary to ensure a diverse sample. one of the most common threats to internal validity to any longitudinal research is attrition and loss to follow-up bias. therefore, the thoughtful implementation of retention strategies can prove critical for conducting research among highrisk populations (dumka, garza, roosa, & stoerzinger, 1997) . in regard to such strategies, three major themes emerged when considering how to enhance study retention: (1) specific supports that can help participants remain in the research study, (2) barriers to be aware of that can potentially make it difficult to continue study participation, and (3) the best channels for staying in contact with participants over the course of the study. participants most often reported needs of support in areas of childcare, transportation, and being compensated for their time. these findings align well with previous research, as childcare and transportation needs tend to be more common among vulnerable populations (dilworth-anderson, 2011; haley et al., 2014a, b) . as such, offering support in terms of transportation assistance and compensation could prove beneficial in terms of retention. additionally, many participants recommended home visits by research staff as a potential solution to transportation and childcare barriers. however, it should be noted that while home visits may aid in reducing potential barriers, a number of participants in the current study voiced that they would not feel comfortable with individuals coming in their home. therefore, prior to the use of home visits, researchers must ensure that families feel comfortable with visits taking place within the home or consider giving participants an option of laboratory-only visits. these options support participant decision-making, a recurring theme among participants. logistical factors mentioned to increase retention included providing participants with regular research updates, advanced notice for study appointments, and a sense of familiarity with research staff. in line with these recommendations, studies that consistently engage with participants via appointment reminders and research updates can foster a sense of anticipation and progress in participants (kim, hickman, gali, orozco, & prochaska, 2014) . moreover, a number of researcher characteristics can contribute to participant engagement and retention including being well experienced with the services provided/research protocols, flexibility, being nonjudgmental, and being culturally competent (beasley et al., 2018; o'brien et al., 2012) . high-risk participants often face a disproportionate number of barriers to remaining engaged in research studies (kim et al., 2014) . indeed, it has been documented that retention rates for vulnerable families are often mitigated by higher instances of unpredictable negative life events (e.g., car problems, unreliable phone access, eviction) while possessing fewer resources to compensate for them (heinrichs, bertram, kuschel, & hahlweg, 2005; nicholson et al., 2011) . additionally, it has been found that low-income, high-risk families tend to move more often than those in elevated ses categories, while also being at a higher risk for experiencing evictions and homelessness (phinney, 2013) . participants in the current study mentioned barriers related to work schedules, inconsistent daily routines, a lack of childcare, and the potential lack of child interest when children are older. despite these barriers, a number of studies have made attempts to work around some of these issues. for example, studies have been successful in addressing schedule barriers by allowing participants to designate appointment times that would be most convenient for their family (dumka et al., 1997) , by meeting participants in-person at a hospital or clinic appointment (kim et al., 2014) or by offering services within the home to reduce transportation and child care needs (fifolt, lanzi, johns, strichik, & preskitt, 2017) . moreover, it has been found in vulnerable populations that providing childcare and an environment that is child-friendly can ease parents' burden as well and boost young children's motivation and interest in participating (chaffin et al., 2009; dumka et al., 1997) . the most common methods for maintaining contact with participants throughout the 10-year study period that were recommended by participants were personal phone number, email, social media, and home address, in that order. while personal phone numbers can provide the most immediate access to an individual, mobile phone numbers have been found to change more often than other modes of contact, such as email or even social media accounts (haley et al., 2014a, b) . therefore, gathering as many contact modalities as possible, as well as contact information from two close friends or family members, can contribute to better participant tracing and retention rates (haley et al., 2014a, b; nicholson et al., 2011) . this study may be limited in generalizability by sample demographics. caution should be used in applying the findings of these high-risk participants to all women at-risk of substance use in pregnancy. this study was also limited because the research method changed during the course of the study due to covid restrictions, resulting in the combination of a focus group with individual interviews. in addition, almost half of the women interviewed were from the oklahoma site. findings should be interpreted in light of these limitations. overall, the current study adds vital information to understanding the complexities of marketing, enrollment, and retention strategies when conducting research with participants that are at high risk for substance exposed pregnancies. several key factors proved to be important across a variety of areas related to enrollment and retention. specifically, transportation was found to influence enrollment decision-making, as a barrier to joining a research project and as a support that was needed to stay in a research project. childcare is another area that was reported to impact enrollment and retention. these results indicate the importance of understanding transportation and childcare availability during data collection and to consider ways to support participants in accessing the study location with child supports in place. other key areas that were discussed within enrollment and retention were benefits of the study and compensation. specifically, participants reported that understanding the benefits to self and others was important. these findings indicate the importance of reporting potential benefits and compensation not only when recruiting participants to enroll in a research project, but also to continue this conversation to retain research participants. lastly, across enrollment and retention, busy schedule of participants is an important consideration. leaning on another theme within the retention strategies, it is important to remain flexible with scheduling data collections so that participants are able to work appointments around a potentially chaotic schedule. a potential research barrier in the current study is the possibility that participants might have difficulties in conceptualizing the continuum of engagement in a longitudinal research study without actually being enrolled and experiencing the study. to mediate this barrier, many of the participants in the current study had been involved in other research in an effort to include participants that had some research experience. additionally, answers to qualitative questions were varied and robust which indicates that participants had a wealth of ideas regarding engagement in research. another potential limitation of the current study was that all participants were considered "high-risk." to remediate this limitation, researchers from the current study are currently analyzing qualitative data to determine potential key differences in engaging low-risk versus high-risk participants in longitudinal research. it is important to note that although it was not specifically examined in this study, it is crucial for researchers and staff to be trained in, and understand, culturally competent methods for recruitment, data collection, and retention. this is particularly the case for building trust among researchers and participants from different cultural and high-risk backgrounds. for example, bicultural research staff and bilingual team members are needed, as well as specific training regarding cultural norms and sensitivity (see mendez, 2010; beasley et al., 2020) . overall, researchers need to be aware of barriers to enrollment and study engagement strategies for recruiting and retaining high-risk participants in research. future research should focus on understanding further behaviors and techniques in supporting high-risk participants, as engaging this population is essential for understanding developmental trajectories of risk and resilience among children starting already at risk for mental and physical health difficulties. funding this work was supported by the national institute on drug abuse (nida) research grant numbers r34da050343 (lob, jmc, and asm) and r34 da050237 (lnb, js, and ll). conflict of interest the authors declare that they have no conflict of interest. disclaimer the views and opinions expressed in this manuscript are those of the authors only and do not necessarily represent the views, official policy, or position of the u.s. department of health and human services or any of its affiliated institutions or agencies. a systematic review of the experiences of vulnerable people participating in research on sensitive topics cannabis use among women of reproductive age in the united states patterns of opioid utilization in pregnancy in a large cohort of commercial insurance beneficiaries in the united 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recognizing the importance of having a broad exploration of how cultural perspectives may shape thinking about ethical considerations, the centers for disease control and prevention (cdc) funded four regional meetings in africa, asia, latin america, and the eastern mediterranean to explore these perspectives relevant to pandemic influenza preparedness and response. the meetings were attended by 168 health professionals, scientists, academics, ethicists, religious leaders, and other community members representing 40 countries in these regions. methods: we reviewed the meeting reports, notes and stories and mapped outcomes to the key ethical challenges for pandemic influenza response described in the world health organization’s (who’s) guidance, ethical considerations in developing a public health response to pandemic influenza: transparency and public engagement, allocation of resources, social distancing, obligations to and of healthcare workers, and international collaboration. results: the important role of transparency and public engagement were widely accepted among participants. however, there was general agreement that no "one size fits all" approach to allocating resources can address the variety of economic, cultural and other contextual factors that must be taken into account. the importance of social distancing as a tool to limit disease transmission was also recognized, but the difficulties associated with this measure were acknowledged. there was agreement that healthcare workers often have competing obligations and that government has a responsibility to assist healthcare workers in doing their job by providing appropriate training and equipment. finally, there was agreement about the importance of international collaboration for combating global health threats. conclusion: although some cultural differences in the values that frame pandemic preparedness and response efforts were observed, participants generally agreed on the key ethical principles discussed in the who’s guidance. most significantly the input gathered from these regional meetings pointed to the important role that procedural ethics can play in bringing people and countries together to respond to the shared health threat posed by a pandemic influenza despite the existence of cultural differences. before the 2014 ebola outbreak in west africa captured the world's attention, one of the most feared yet widely anticipated events in public health was a pandemic of highly pathogenic influenza. in the 20th century, there were three notable influenza pandemics -the "spanish flu" (h1n1 virus) in 1918 and 1919, which resulted in approximately 50 million deaths worldwide 1 ; the "asian flu" (h2n2 virus) in [1957] [1958] , which resulted in 1-2 million deaths worldwide 2, 3 ; and the "hong kong flu" (h3n2 virus) in 1968, which resulted in 1 million deaths worldwide. 4, 5 in the late 1990s and in early 2000s, concern focused on the spread of avian influenza virus h5n1 to humans. the first cases of human infection with h5n1 were reported in 1997 in hong kong (18 cases of which 6 were fatal). [6] [7] [8] [9] fears about h5n1 were heightened in 2003 when the virus was found to be responsible for serious disease and death in humans. nearly 650 human cases of h5n1 have been reported from 15 countries since 2003 through october 2015. 4 other outbreaks led to questions about preparedness. the outbreak of severe acute respiratory syndrome (sars) in 2003 contributed to growing concern about the world's ability to prepare for and respond to a worldwide epidemic. sars, first reported in asia in february 2003, is a viral respiratory illness caused by a coronavirus. the illness spread rapidly to more than two dozen countries in north america, south america, europe, and asia before the sars global outbreak was contained in 2004. 10 the reemergence of the h1n1 virus during the 2009-2010 influenza season, 11 the emergence of the middle east respiratory syndrome coronavirus (mers-cov) in 2012, 12 and the cases of severe illness in humans from a new avian influenza a (h7n9) virus in 2013 13 heightened concerns about the need to be prepared for pandemics. an influenza pandemic results in a sudden surge of people with acute health needs, placing extra burden on health resources already overstretched in many places. the severity and suddenness of these burdens can create ethical tensions along a number of fronts. one such tension to which policymakers already have given considerable attention is the ethical allocation of scarce supplies of antivirals, vaccines, respirators, and personal protective equipment. [14] [15] [16] [17] healthcare workers will encounter challenging ethical dilemmas involving their professional duties to patients and their strong competing obligation to protect and care for themselves and their family. the employers of these workers will have obligations to minimize risks to their employees, while countries will have obligations relating to international collaboration that can compete with domestic priorities. at the request of member states, the world health organization (who) convened an international group in 2006 to identify common ethical concerns in preparing for and responding to a pandemic influenza and to provide preliminary guidance on how to address these issues. this resulted in the 2007 release of ethical considerations in developing a public health response to pandemic influenza. 18 in addition to discussing general ethical considerations (eg, balancing rights, interests and values, transparency and community engagement), the who ethics guidance discussed issues relating to priority setting and equitable access to therapeutic and prophylactic measures; use of isolation, quarantine, border control and social distancing measures; and the role and obligations of and to healthcare workers. an overriding theme for the who guidance was the need for international cooperation and the importance of taking into account the contextual and cultural considerations of particular countries or regions. the who document notes that "ethical considerations will be shaped by the local context and cultural values. " 18 cdc also developed ethical guidance relating to pandemic influenza. 19, 20 this guidance focused on ethical issues relating to allocation of scarce resources and use of public health interventions which may limit individual liberties. in addition to the who and cdc documents, there is considerable literature devoted to ethical considerations in pandemic influenza preparedness and response. [21] [22] [23] [24] [25] [26] [27] [28] [29] [30] [31] however, whereas most of this literature assumes a liberal democratic perspective in considering ethics and values, many countries that would partner in a global pandemic response are more hierarchically structured. in hierarchical societies, citizens tend to implicitly expect and trust decisions from their leaders. notwithstanding that liberal democratic societies emphasize individual autonomy, collective decision-making and the interrelatedness and interdependence of community members are fundamental to every human society. 32 because in hierarchic societies these factors have greater visibility, in such societies the success of public health interventions will depend on engaging recognized tribal, community or religious leaders in decision-making. recognizing the importance of having a broader exploration of how cultural perspectives may shape thinking about ethical considerations, cdc sponsored meetings in africa, asia, latin america, and the eastern mediterranean to explore various cultural perspectives relevant to pandemic influenza preparedness and response. the meeting in africa was held in collaboration with who and the african field epidemiology network (afenet) in kampala, uganda on august 11-15, 2008 ) in sharm el sheikh, egypt on december 5-6, 2011. the key objectives for all four meetings were to: (1) identify culturalspecific ethical challenges in pandemic influenza detection and control, (2) explore approaches for addressing these ethical challenges, including how to best integrate ethical considerations into country/regional pandemic influenza preparedness and response guidelines and implementation strategies, and (3) begin establishing a social network to foster continued discussion about ethical issues in the practice of public health. the meetings were attended by government health officials and policy-makers, public health practitioners, scientists from academic and research institutions, epidemiologists, philosophers, ethicists, religious leaders, and representatives of international aid and health organizations. the african meeting was attended by 71 people, including representatives from 12 african countries (nigeria, south sudan, south africa, zimbabwe, togo, mali, cameroun, burkina faso, tanzania, kenya, egypt, and uganda). the asian meeting was attended by 30 people, including representatives from 9 countries (cambodia, china, india, indonesia, laos, myanmar, philippines, thailand, and vietnam). the latin america meeting was attended by 33 people, including representatives from 11 latin american countries (argentina, brazil, columbia, costa rica, dominican republic, el salvador, guatemala, honduras, mexico, panama, and peru). the eastern mediterranean meeting was attended by 34 people, including representatives from 8 countries (egypt, afghanistan, pakistan, sudan, yemen, iraq, jordan, and morocco). for this paper, we reviewed the reports, notes, and stories resulted from the four regional meetings. we mapped outcomes from the meetings to five key ethical challenges identified in the who guidance: transparency and public engagement, allocation of resources, social distancing, obligations to and of healthcare workers, and international collaboration. we report here the objectives, processes, and ethical issues discussed at these meetings as they relate to the who key ethical challenges. in addition, each of the coauthors of this paper attended at least one of the four meetings. description of processes used in organizing the regional meetings to ensure that everyone had the basic knowledge needed to engage in the discussions, all meetings began with overviews of influenza biology, epidemiology, and history, including lessons learned from past influenza pandemics and the 2003 sars pandemic. the focus of the meetings was on planning for a highly pathogenic h5n1 influenza; however, the h1n1 influenza was running its course during the asian meeting and discussion of that epidemic entered the conversation. information was presented on the 2007 who 18 and 2007 cdc 14 ethics guidance documents as a starting point for discussing how ethical considerations may differ between countries. in addition, there were presentations on the basic principles of public health ethics and how it differs from more traditional clinical and research ethics approaches, and discussion of ethical challenges that are likely to arise in response to planning for and responding to pandemic influenza. the latin america meeting also included a session on human rights. out of respect for local partners, somewhat different processes were used in the four meetings to generate discussion of ethical issues. in the african meeting, participants met in small groups to discuss pre-developed case studies addressing the topics of non-pharmaceutical interventions, obligations of healthcare workers, and equitable access to treatment and prophylaxis. participants were asked to consider the case in light of specific challenges they may face in their countries. in the asian meeting, participants met in small groups and were asked to develop their own short narratives about the ethical issues they thought would be important in a pandemic influenza and how the values and cultural consideration in their counties would impact approaches for addressing these ethical issues. participants wrote short narratives answering the following prompt: prior to this meeting, a close friend explains that he does not understand why ethical issues are important in a pandemic response. what experience, either yours or someone else's would you share to illustrate the significance and importance of public health ethics in a pandemic response? during the latin america meeting, participants, grouped by country, were asked to identify key points for integrating ethics into emergency plans. during the eastern mediterranean meeting, participants were asked to share stories about ethical issues encountered during public health responses and to discuss how these issues were addressed in their response plans. organizers took minutes and notes of meeting proceedings and developed summary reports for all meetings. unpublished reports are available at request. for each of the organizing topics below, we first present some common themes discussed at the four meetings followed by more specific perspectives from each of the meetings in chronological order of when the meetings were held, beginning with african perspectives (august 2008), followed by asian perspectives (march 2010), latin american perspectives (july 2011), and eastern mediterranean (december 2011) perspectives. the who framework was used as a starting point for discussion at all meetings, but due to the characteristics, nature of events, and interests of local partners, discussions were not always focused on the same issues. discussions at the two latter meetings were by-andlarge affirming of the perspectives discussed at the two former meetings. based on the meeting reports, fewer details related to the ethical challenges emerged from the latin america and eastern mediterranean meetings than are for the africa and asian meetings. transparency, in which relevant information is made freely available, and public engagement were seen by participants at all meetings as factors critical to an effective response during a pandemic influenza emergency. many related issues were discussed, including low literacy level, poverty, and trust of and/or deference to health authorities. some cultural variations were expressed; for example, that certain societies more readily accept autocratic directives for disease control. participants at all meetings affirmed that their cultures do not tolerate corruption and indicated that a lack of transparency raises suspicions of corrupt dealings. government authorities and leaders are expected to be open and consult the community in making important decisions, including public health emergency decisions, affecting their people. factors that complicate mass communication that were discussed at all meetings include low levels of literacy, the inaccessibility of media such as television, newspapers, and the internet because of poverty; and the unavailability of the internet and cell phone towers in some rural areas. although the detail and depth of discussions regionally varied and some cultural variation was evident, transparency in decision-making was in general decisively affirmed. at the african meeting, in contrast to the general perception that "big men" and individuals with centralized power make all of the decisions, participants agreed that traditional cultures expect leaders to seek input from those they lead, through elder councils and similar institutions. participants noted that public health leaders include traditional healers who serve as both recipients of and conduits for information. because many africans will seek care from traditional healers during a pandemic, these health providers must also be informed of how to protect themselves from infection, and how to guard against spreading the infection. in addition, a wide variety of local and international non-governmental organizations (ngos), often funded by high-income countries, are active in resource poor countries in africa seeking to meet the populations' most basic needs. thus, it is important that both traditional healers and ngos be engaged in the decisionmaking process. the participants at the asian meeting varied widely in their views and practices relating to informing and engaging the public. for example, when sars broke out in one asian country, the government issued mandatory public health measures and expected public compliance. due to the culture of deference to authority, nearly all communities in this country instantly adopted the measures (eg, quarantine, isolation, and social distancing). however, not all participants reported such deference to authority. this was reflected in a story from another asian country about a boycott of a government polio immunization campaign by a minority community due to suspicions about the government's motives. others reported that when the central government was perceived as misgoverned or weak, responsibilities for informing the public about health threats and providing leadership during emergencies fell to local leaders. participants at the latin american meeting stressed that community participation and cooperation will be crucial during a pandemic influenza response, particularly for migrants or minorities who are already stigmatized. latin american participants also pointed to the importance of the media and health authorities in communicating health information and avoiding panic, as well as to convey factual information about availability and access to therapeutics. some participants were concerned about the wide disparity in resources within and between countries, which make transparency even more important. participants at the eastern mediterranean meeting emphasized the need for inclusion, accountability, and transparency in public health policies, but also noted the reluctance among countries to collaborate because of political differences and disparity in wealth and resources. participants discussed the need to establish a clear understanding of who will make what decisions during an emergency, how guidelines will be established, and the importance of considering multiple perspectives, including perspectives from individuals most at risk. allocation of scarce resources economic, demographic, geographical, and population vulnerability factors were common challenges identified as affecting resource allocation decisions. these challenges were shared in all regions where the meetings occurred. participants agreed that because of the cultural and regional variations, a "one size fits all" approach to any planning and response activity is unlikely to be optimal and should be questioned and challenged. however, although differences were acknowledged, there were also shared understanding and general agreement on the importance of the ethical values discussed at the meetings. participants felt that planning and response should take into account contextual variations and cultural differences. additionally, participants discussed the issue of resource allocation within the framework of transparency, especially when preferential treatment is given to the most powerful community members as opposed to the most vulnerable. the african meeting participants affirmed the importance of providing resources to the young, but noted important differences in perspectives among countries. many african societies give higher status to the elderly than to other age groups. with a life expectancy for some african countries in the 40s and even 30s, the proportion of the population composed of young children is much higher than in other countries. thus, in african countries, a preference of allocating scarce resources to children would leave little resources for other segments of the population. generally, african countries are much more rural than are countries of other continents, making access to villages difficult, whether by road, telephone, or internet. although meeting attendees did not feel that rural or urban habitation should be a criterion for allocation of resources, they anticipated that logistical challenges would make it so. these concerns are dwarfed, however, by the likelihood that resources such as antivirals and vaccine will be far scarcer in african countries than elsewhere because of the continent's dual challenge of weak economies coupled with the number of other endemic health challenges, such as malaria and hiv/ aids. with few resources at hand, the ethical imperative to respond to pandemic influenza may fall below that of addressing hyperendemic fatal diseases. each of the countries represented in the asian meeting had a pandemic flu preparedness plan that addressed allocation issues and maintained a national stockpile of antiviral drugs. in most cases, biological vulnerability determined priority; thus, the very young or very old, pregnant women, and immunecompromised individuals tended to be prioritized to receive antiviral drugs. however, as asian cultures exhibit more hierarchy than those in the west, more honor is accorded to the elderly, senior staff, royalty, and public service personnel in asian cultures. in addition, it is expected that relatives and friends of the powerful will be unofficially prioritized to receive limited resources, without that being considered unethical. indeed, in many asian contexts, such prioritization is viewed as a social obligation (eg, a health worker would consider offering antivirals from the limited supply to a senior official before offering the resources to a person in one of the official priority groups). nevertheless, participants expressed disapproval of officials who abuse their power and demand or extort limited resources for themselves. one participant described a shortage of n95 face masks (masks that can filter at least 95% of particles from the air) during the sars epidemic. although some people were willing to pay twice the regular price for a n95 mask, yielding to this demand would in effect favor protection for the rich over the poor. the participants felt the government had a duty to enforce price controls in order to ensure an adequate supply. as an example of enforcing price controls, one government instituted licensing for antiretroviral distribution to put a ceiling on the costs of the medications. some of the asian perspectives on ethical distribution differed by religion. an appeal to buddhist beliefs stated a priority for those who are most severely ill, and the young making sacrifices for their elders. a priority for women and children was expressed with reference to catholic values. when a choice must be made between a mother and her child, participants at the asian meeting felt that catholic values would typically give preference to the mother. some asian nations include island archipelagoes. it will be difficult for populations living on minor remote islands to access medical services and resources during a pandemic. the participants questioned whether their country plans address the challenges that certain geographical conditions may place on the equitable distribution of resources. many participants of the latin american meeting thought that individual rights were paramount and that during a pandemic a clear communication plan that includes community input into the process for drug allocation would help avoid panic. they emphasized the importance of including all sectors of society, including the private sectors, migrants, and minorities in public health decision-making process. issues such as discrimination and stigmatization of certain sectors of the population must be addressed before an emergency situation arises. meeting participants stressed that emergency plans should take into account the diversity of population, must be transparent, and favor equal distribution of resources. at the eastern mediterranean meeting, participants discussed the need to evaluate "what is good for you versus what is good for others. " this included discussing ethical challenges associated with distribution of scarce resources. questions that were explored included: which group of people should be vaccinated first? who will make decisions about distribution? one theme that was identified from this discussion was the importance of prioritizing healthcare workers for access to limited resources, including medical and psychological care and other social benefits, should they become sick during an emergency. the use of social distancing to limit transmission was widely accepted as an important tool in a pandemic influenza response, but participants warned of the many factors and challenges that complicate this traditional public health measure. these include socio-economic factors (eg, densely populated settings), and cultural factors (eg, family duty, funeral rituals). participants in the african meeting agreed with the social distancing principles described in the 2007 who document, 20 including making the measures voluntary to the greatest extent possible; ensuring "safe, habitable, and humane conditions of confinement including the provision of basic necessities (food, water, clothing, medical care, etc)"; and employment protection for workers who comply with social distancing measures against the wishes of their employers. participants stressed that isolation and quarantine measures will be more difficult to enforce in rural compared to urban areas in africa due to the isolated geography of some rural areas and the lack of healthcare workers and security officials. however, participants noted that these public health measures have been successfully employed in rural areas in prior epidemics in africa. densely populated urban slums were also noted to present a challenge to social distancing. in a typical slum dwelling, people occupy all available sleeping space at night in small and poorly ventilated homes. there is no separate space available for isolation or quarantine. the same applies in some refugee camps. in such densely populated settings, the lack of freedom of movement may lead to near-certainty of transmission. neighboring communities will be tempted to protect themselves by fencing off the slums or forcibly preventing the exit of slum residents. there was also concern among the participants that some african countries would rely heavily on military personnel to impose order, potentially with unnecessary force. participants in the asian meeting also noted challenges associated with the use of social distancing measures. duty to family is a major theme of confucian philosophy. in some asian countries, it is a tradition for friends and relatives to visit and even stay with a hospitalized person. in many instances, exhortations to family and friends about the serious nature of isolation are no match for the force of tradition: some find a way in and out of the isolation wards. due to the lack of resources, isolation wards do not have security guards, and nursing staff are not able to add policing to their already heavy workload. a common concern reported by participants at the asian meeting was the risk of stigmatization of patients and family members who were placed in isolation and quarantine. one of the participants reported that during the sars outbreak, an entire village was stigmatized because it was home to one of the cases. anybody known to have come from the village was avoided by others. workers from the village were not admitted to their place of employment outside the village. similarly, students were kept out of their schools. when the village was eventually quarantined, people feared delivering food and supplies. the stigma remained long after the epidemic subsided and the quarantine was lifted. high rates of poverty also pose a challenge for use of social distancing measures. it is difficult for patients to remain in isolation wards or for potentially exposed individuals to remain quarantined for long period of time unless compensation can be offered for lost wages. participants at the latin american and eastern mediterranean meetings reflected on the long history of human rights abuses in their countries. this made them more likely to view use of social distancing measures as something that should be considered with great caution. some even viewed these measures as human rights violations. obligations to and of healthcare workers healthcare workers have multiple obligations, including obligations to their patients, to their employers, to their governments, to themselves, and to their families. participants at all meetings understood that healthcare workers cannot completely sacrifice their and their family members' health and well-being as they fulfill their public health duties during an emergency response. participants at the african meeting felt that healthcare workers have the right to stop working if they feel they are not wellprotected. factors discussed included the challenges related to the displacement of health workers during post-election conflict, traditional or cultural practices that may increase the risk of disease spread (eg, hugging or handshaking), and conflicts between senior officials and frontline healthcare workers regarding access to resources. they felt that frontline health workers should have first priority. a complicating factor in many african countries is the presence of large numbers of health-care-related ngos from a variety of countries. what obligations would they have in a pandemic? if the workers or the organizations were to leave the country to attend to the needs of their home country or their families, the african country could lose a sizable proportion of its health workforce. and yet host governments have little authority to demand their assistance. socio-economic factors were predominant in stories told by participants at the asian meeting. for example, during sars outbreak, some private hospitals in one country were only admitting patients who could pay, while some suspected patients did not go to hospitals because they could not pay the inpatient care that could exceed $250 per day in a country where per capita annual income is less than $3000. some countries reported lack of personal protective equipment, such as face masks, for healthcare workers; or differences in the degree of protection offered according to position (eg, physicians offered more protection than nurses). participants reported that some healthcare workers refused to treat suspected cases, because either they did not have protective equipment and/ or because they were concerned for their own safety and the safety of their loved ones to whom they would return after work. the participants agreed that healthcare facilities and governments had an ethical obligation to adequately and equitably provide personal protective equipment to their employees. in addition, participants felt that education of the employees about transmission control and, in some instances, additional incentives such as hazard pay, can help overcome the hesitancy of healthcare workers to remain on duty during a pandemic surge in cases. participants at the latin american and eastern mediterranean meetings also discussed the roles of healthcare workers during influenza pandemic. participants at both meetings recognized the important responsibilities healthcare workers have to treat patients regardless of the risk to themselves, but also noted that governments have responsibilities to protect healthcare workers. some participants believed that healthcare workers have the right to refuse treatment to patients if the provider fears exposing their own family and that society has an obligation to compensate their families if they die while treating patients. other participants felt that doctors do not have the right to refuse treatment because of their oaths and duties as physicians. international collaboration international collaboration is complicated by many factors, including disparities in resources, political differences, ethnic tension, and distrust. participants, however, agreed that during a pandemic, collaboration is critical, because diseases respect no boundary. participants pointed out that no country, developed or undeveloped, has eliminated poverty and the underlying causes of ill-health, such as lower literacy among the poor and less knowledge about disease prevention. the prevalence of poverty affects not only individuals, but institutions and systems. because of the interdependence of nations, participants thought that it is in the best interest of resource rich countries to help build the capacity of poorer countries to conduct surveillance and disease control. participants in the african meeting stressed that the ability of a developing country to conduct thorough and accurate surveillance depends in large part on the assistance of developed countries in building and maintaining basic public health infrastructure well before a pandemic occurs. moreover, by its very nature, surveillance is an ongoing process, not one that can be initiated in the face of an emergency response and then terminated when things return to normal. in emergencies, international scientists may temporarily fill some personnel gaps. participants observed, however, that some international scientists providing technical assistance during an emergency seem more interested in research than in helping to control the disease outbreak. in some cases, they even diverted resources, such as healthcare workers, that could have been used for disease control. lack of wellequipped laboratories in many african countries has resulted in the transfer of human biological specimens to distant laboratories, sometimes delaying diagnosis and intervention. some surveillance resources are provided by donor nations for specific purposes such as measles eradication. strict accounting rules may prevent the shift of those resources to other purposes, even in the face of a major global threat. the asian meeting participants also expressed concern about specimen sharing. during outbreaks of sars and h5n1 influenza, for example, china shared its specimens with countries around the world for research and vaccine development. 33 during the outbreak of h1n1 in 2009, who noted that 150 countries shared specimens. 34 the asian participants noted that collaboration and communication about disease transmission requires a transparency that can be at odds with the cultural value of 'protecting honor' and 'avoiding being shamed' that is common in asia and elsewhere. reporting an outbreak to other countries can be perceived as admitting inadequate disease control and asking for help from another country may be viewed as a sign of weakness. this is complicated by often pre-existing disputes between neighboring countries. moreover, while helping others is also an important asian cultural value, offering help when a country has not asked for it may be regarded as meddling with the internal affairs of that country. moreover, two asian countries who conducted a joint outbreak investigation exercise observed that multilateral coordination can be time-consuming in ways that hinder a speedy and effective response. participants at the latin american meeting believed that it is important to clarify and disseminate guidelines for pandemic preparation and response, including those produced by who. dissemination of pertinent information and guidelines between countries was considered as an obligation countries have to one another. some noted that although wide disparity exists among latin american countries, there is a great deal of solidarity, which facilitates cross-border collaboration, such as seen in the collaboration between haiti and the dominican republic during the haiti earthquake and resulting cholera epidemic in 2010. participants at the eastern mediterranean meeting noted that countries are sometimes reluctant to collaborate because of the political and resource differences and other disparities between countries in the region. however, they agreed that plans for responding to an influenza pandemic should be shared among countries so that countries will be familiar with neighboring countries' plans. participants believed that country or even regional plans are too broad and more specific sub-regional plans should be developed and implemented. although the ethical concerns raised by participants from these four distinct regions (africa, asia, latin american, and the eastern mediterranean) describe important issues that can shape responses to an international pandemic, the similarities of the perspectives and the concerns were notable. participants reaffirmed the importance of the five key ethical issues framed by who (ie, transparency and public engagement, allocation of resources, social distancing, obligations to and of healthcare workers, and international collaboration). participant feedback can be summarized as followed: • the procedural values of transparency and inclusiveness are widely accepted and crucial for ethical decisionmaking. • no "one size fits all" approach to allocating resources can address the variety of economic, cultural and other contextual factors that must be taken into account, but engaging with communities can help both to discover these factors and to build support for public health recommendations. • although meeting participants acknowledged the importance of social distancing as a tool to limit disease transmission, they also recognized the difficulties associated with this measure. • healthcare workers often have competing obligations that can compromise their ability to fulfill public health duties during an emergency response. government has a responsibility to assist them in doing their job by providing appropriate training and equipment. • although international collaboration may be difficult, a focus on procedural ethics (ie, procedures that ensure transparency, consistency, inclusiveness, and a fair hearing of concerns in a deliberative format) make collaboration possible in efforts to combat global health threats. the discussions from the meetings offer perspectives on how countries can collaborate in the control of international pandemics while respecting different cultural values. although we initially were concerned that cultural differences could seriously impede international collaborations, we believed that anticipatory awareness of value differences would help prevent them from becoming potential stumbling blocks. given this outlook, the meeting organizers were poised to highlight cultural differences. indeed, the meeting exposed numerous cultural differences; eg, people in asian countries more readily defer decision-making to government officials, elders, or other authority figures. many of the differences that surfaced during the meetings reflected differences in how decisions are reached in the context of a country's political arrangements. moreover, as the discussion of resource allocation illustrated, differences in local contexts and traditions necessarily will play a role in how interventions will be implemented. nevertheless, the similarities in perspectives between countries challenged our initial expectation that cultural differences would seriously impede if not prevent collaboration. attempts to change traditional cultural practices frequently fail or result in unintended consequences. however, addressing procedural ethics according to established international norms can assist with overcoming cultural differences within the context of global disease pandemic, political organization or local context. for example, the complicated ritual washing of bodies became a contentious issue in the 2014-2015 ebola response, because of its role in facilitating the spread of ebola virus. culturally, this practice was considered an essential part of preparing the dead for the after-life. 35 public health and government workers contemplating halting or altering ritual practices require great cultural sensitivity and finesse in presenting alternatives that are perceived as fair and acceptable to a community already suffering from irreplaceable loss of their loved ones. the recent who ethics workgroup on ebola again illustrates the importance of a focus on procedural ethics. 36 the workgroup included, along with ethicists and subject matter experts on ebola, representatives from the three west african countries hit hardest by the ebola virus. in relatively short order, the workgroup came to agreement on prominent ethical issues, such as the use of promising experimental drugs against ebola virus, the need to conduct research on these drugs, and the importance of informed consent even during a public health emergency. their success suggests that, when a fair process is established that includes the voices of those affected by the outbreak, a pandemic involving a deadly disease can bring countries rapidly together around the shared value of health, rather than divide them on the basis of cultural differences. perhaps the consensus regarding the importance of combating a pandemic health threat was to be expected, given that cdc or its partners such as tephinet sponsored and coordinated all four meetings, and, more importantly, the 2007 who ethics guidance framed the discussions of ethics topics. perhaps the participants consciously or subconsciously stated what they thought the sponsors wanted to hear. in addition, as many of the participants were public health officials, they brought with them a shared commitment to addressing health concerns. it is possible that the input of these health professionals, more numerous and vocal than other participants, explains the observed continuity around health-related matters. however, these conjectures do not seem compelling. cdc's sponsorship and the framing of discussion around the who's topics did not of themselves preclude major differences from surfacing within any particular topic. it also seems highly unlikely that the majority of differences were to be found outside of those ethics topics discussed at the meeting. the same who framework that oriented the participants to these topics also oriented them to the theme of cultural differences. moreover, the exercises, discussions, and responses were open ended and varied rather than being highly directive. it also seems improbable that participants were merely telling us what we wanted to hear and held back from expressing profound differences when the purpose of the meetings was precisely to explore cultural differences. a simpler and more compelling explanation lies in a crosscultural continuity regarding the importance of combating the health threats that would result from a pandemic event. this continuity should come as no surprise. human rights advocates, for example, deem health so fundamental to human flourishing that they consider it a basic human right. [37] [38] [39] [40] [41] the "right of everyone to the enjoyment of the highest attainable standard of physical and mental health. " is encapsulated in article 12 of the international covenant on economic, social, and cultural rights (cescr), a covenant which 164 out of 197 countries have thus far ratified. 42, 43 similarly, the capability approach maintains that the freedom to achieve well-being is a primary human capability that creates the opportunity for people to realize other capabilities they value. campbell describes health as a liberation or freedom not only from pain or illness, but also as a freedom that allows a person to "create, inhabit a space, to simply live, and share the world around us. " 44 for campbell, the concept of health lies in this freedom. he further believes that the meaning of health reflects personal values and beliefs that are closely linked to the local community and socio-cultural group. health in this view and as a matter of common human understanding is seen as a gateway, if not precondition, for developing other human functions and capabilities. it is a matter, then, not only of ethical theory but also of practical human life that pandemics, which pose existential threats to health, could be expected to elicit similar responses across cultures. there are a number of limitations associated with this manuscript. the manuscript reflects what we found of most interest in the reports, notes, and stories generated from the four regional meetings. it does not provide a complete reporting of the meeting proceedings; rather, it focuses on the parts of the discussion that were related to the key ethical challenges identified in the who ethical framework document. the meetings were meant to initiate an international dialogue about how ethical considerations can be incorporated into pandemic influenza preparedness among members of the field epidemiology training programs, public health officials, policy-makers, scientists, ethicists, religious leaders, and representatives of international aid and health organizations. the meetings were not part of a research study meant to develop new or generalizable knowledge. participants were not recruited in a systematic fashion. cdc relied on local partners to identify and nominate participants to attend the regional meetings. meeting agendas, sessions, and structures were tailored to the local interests and circumstances. although participants were oriented to the who ethics framework at the beginning of each meeting, discussions were not always focused on the same issues. this may explain the lack of consistency in the amount and depth of the discussions on the key ethical challenges identified in the who document. if the analysis and explanations above are sound, then it indicates that cultural differences need not pose a serious challenge for collaboration between countries in addressing an international pandemic. likewise, substantive ethical differences need not pose a serious impediment to pandemic preparedness efforts especially if more attention is paid to procedural ethics, that is, to procedures that ensure transparency, consistency, inclusiveness, and a fair hearing of concerns in a deliberative format. 45 if any lesson is learned from past pandemics, it is that each one informs our response to the next. likewise, the ethical issues raised by past public health emergencies should serve to better prepare ourselves to effectively respond to the next emergency. 46 the same applies to the discussions generated by the regional meetings described in this document. they affirm the notion that, cultural differences notwithstanding, people and countries will come together to combat the health threat a pandemic influenza poses to all, when fair procedures are established that give those affected a seat at the table and a voice. pandemic flu history. department of health and human services (flu.gov) website h2n2. department of health and human services (flu.gov) website lessons from previous influenza pandemics and from the mexican response to the current influenza pandemic h5n1. department of health and human services (flu.gov) website influenza epidemics and pandemics avian influenza virus h5n1: a review of its history and information regarding its potential to cause the next pandemic influenza viruses and the evolution of avian influenza virus h5n1 avian influenza: the next pandemic? disease-a-month h5n1 avian influenza: timeline of major events -25 january. world health organization website severe acute respiratory syndrome h1n1 virus transmission and outbreaks update: severe respiratory illness associated with middle east respiratory syndrome coronavirus (mers-cov) -worldwide avian influenza a (h7n9) virus. centers for disease control and prevention website stockpiling antiviral drugs for pandemic influenza: the key ethical principles. prepared by the ethics subcommittee of the advisory committee to the director ethical considerations for decision-making regarding allocation of mechanical ventilators during a severe influenza pandemic or other public health emergency. prepared by the ventilator document workgroup, ethics subcommittee of the advisory committee to the director identifying prioritization criteria to supplement critical care triage protocols for the allocation of ventilators during a pandemic influenza public engagement on ethical principles in allocating scarce resources during an influenza pandemic ethical considerations in developing a public health response to pandemic influenza. world health organization website ethical guidelines in pandemic influenza ethical guidelines in pandemic influenza: recommendations of the ethics subcommittee of the advisory committee of the director ethics and pandemic preparedness: the importance of cross-jurisdictional and cross-cultural perspectives ethical reasoning in pandemic preparedness plans: southeast asia and the western pacific influenza pandemic preparedness: legal and ethical dimensions kayman h, ablorh-odjidja a. revisiting public health preparedness: incorporating social justice principles into pandemic preparedness planning for influenza joint massachusetts department of public health-harvard altered standards of care working group on pandemics and the duty to care: whose duty? who cares facing the challenges of influenza in healthcare settings: the ethical rationale for mandatory seasonal influenza vaccination and its implications for future pandemics a matrix for ethical decision-making in a pandemic. the oregon tool for emergency preparedness pandemic influenza preparedness: an ethical framework to guide decisionmaking an ethics framework for public health and avian influenza pandemic preparedness why china's sars legacy may give it an edge against ebola pandemic (h1n1) 2009 -update 77. world health organization website ethical challenges posed by the ebola virus epidemic in west africa ethical issues related to study design for trials on therapeutics for ebola virus disease. who ethics working group meeting report medicine and public health, ethics and human rights towards the development of a human rights impact assessment for the formulation and evaluation of public health policies the right to health in international human rights law what are health and human rights? what is a human-rights based approach to health and does it matter? health hum rights social and cultural rights status of ratification: international covenant on economic, social and cultural rights health as liberation: medicine, theology, and the quest for justice global health as a field of power relations: a response to recent commentaries ebola: the ethics of thinking ahead we acknowledge the invaluable contributions of the following individuals and organizations in organizing the regional meetings, developing meeting reports and summaries, from which this manuscript was based. we especially appreciate the work of mark white (cdc retired) who conceptualized, designed, collected, and analyzed data, and obtained funding and coordinated the regional meetings with external partners. in no particular order, we also would like to acknowledge the contributions of maria consorcia lim-quizon, david mukanga, fred wabwire-mangen, joseph ochieng, patrick nguku, rebecca babirye, dominic thomas, anant bhan, goldie macdonald, andreas reis (who), afenet, emphnet, safetynet, and tephinet. the findings and conclusions in this paper are those of the authors and do not necessarily represent the official position of the centers for disease control and prevention (cdc), the university of north carolina, chapel hill, nc, usa or tephinet at the task force for global health. all coauthors were involved in reviewing reports, stories, summaries, and notes from the meetings described in the manuscript. funding was provided by the united states agency for international development and cdc to support the four regional meetings described in the manuscript. funding was used for travel-related expenses of all participants, including the co-authors of this paper, to participate in one or more of the meetings. not applicable. this manuscript was based on analysis of reports and documentations generated from four cdc-sponsored regional meetings. the meetings were considered routine public health practice and not research per se. key: cord-004339-7nwpic3d authors: rennie, katherine j.; o’hara, james; rousseau, nikki; stocken, deborah; howel, denise; ternent, laura; drinnan, mike; bray, alison; rooshenas, leila; hamilton, david w.; steel, alison; fouweather, tony; hynes, ann-marie; holstein, eva-maria; oluboyede, yemi; abouhajar, alaa; wilson, janet a.; carrie, sean title: nasal airway obstruction study (nairos): a phase iii, open-label, mixed-methods, multicentre randomised controlled trial of septoplasty versus medical management of a septal deviation with nasal obstruction date: 2020-02-13 journal: trials doi: 10.1186/s13063-020-4081-1 sha: doc_id: 4339 cord_uid: 7nwpic3d background: septoplasty (surgery to straighten a deviation in the nasal septum) is a frequently performed operation worldwide, with approximately 250,000 performed annually in the us and 22,000 in the uk. most septoplasties aim to improve diurnal and nocturnal nasal obstruction. the evidence base for septoplasty clinical effectiveness is hitherto very limited. aims: to establish, and inform guidance for, the best management strategy for individuals with nasal obstruction associated with a deviated septum. methods/design: a multicentre, mixed-methods, open label, randomised controlled trial of septoplasty versus medical management for adults with a deviated septum and a reduced nasal airway. eligible patients will have septal deflection visible at nasendoscopy and a nasal symptom score ≥ 30 on the nose questionnaire. surgical treatment comprises septoplasty with or without reduction of the inferior nasal turbinate on the anatomically wider side of the nose. medical management comprises a nasal saline spray followed by a fluorinated steroid spray daily for six months. the recruitment target is 378 patients, recruited from up to 17 sites across scotland, england and wales. randomisation will be on a 1:1 basis, stratified by gender and severity (nose score). participants will be followed up for 12 months post randomisation. the primary outcome measure is the total snot-22 score at 6 months. clinical and economic outcomes will be modelled against baseline severity (nose scale) to inform clinical decision-making. the study includes a recruitment enhancement process, and an economic evaluation. discussion: the nairos trial will evaluate the clinical effectiveness and cost-effectiveness of septoplasty versus medical management for adults with a deviated septum and symptoms of nasal blockage. identifying those individuals most likely to benefit from surgery should enable more efficient and effective clinical decision-making, and avoid unnecessary operations where there is low likelihood of patient benefit. trial registration: eudract: 2017–000893-12, isrctn: 16168569. registered on 24 march 2017. (continued from previous page) discussion: the nairos trial will evaluate the clinical effectiveness and cost-effectiveness of septoplasty versus medical management for adults with a deviated septum and symptoms of nasal blockage. identifying those individuals most likely to benefit from surgery should enable more efficient and effective clinical decision-making, and avoid unnecessary operations where there is low likelihood of patient benefit. keywords: nasal septum, nasal obstruction, septoplasty, turbinates, mometasone furoate, clinical trial, cost-effectiveness, process evaluation background septoplasty is surgery to straighten the nasal partition between the two nostrils (the septum). septoplasty is a commonly conducted operation worldwide, with approximately 250,000 operations performed annually in the us and approximately 22,000 in the united kingdom (uk) [1, 2] . most of these are carried out for nasal blockage and associated symptoms such as a snoring and sleep disturbance. nasal blockage is one of the commonest complaints presenting to otolaryngologists. however, the causes may be multiple, and several may be co-existent. septal deviation or lesions in the nasal passages, such as nasal polyps or enlarged adenoids or turbinates, may cause a 'fixed' sensation of blockage. 'fluctuating' blockage symptoms may be caused by inflammatory conditions of the nasal epithelium such as infective or allergic rhinitis. in addition, the 'nasal cycle', a spontaneous physiological congestion and decongestion of the nasal cavity, compounds the challenge in characterising and assessing nasal patency [3] . the impact of the 'nasal cycle' can be mitigated by measuring nasal airflow following therapeutic nasal decongestion [3] . ideally, the septum runs down the centre of the nose. if it is not straight, perhaps because of injury or a developmental anomaly, it may narrow one or both sides of the nose and obstruct airflow. a perfectly straight nasal septum in adults is rare and some degree of deviation is an accepted norm. however, in instances where there are symptoms of nasal obstruction and a concomitant deviation of the septum, patients may be offered the septoplasty operation. on the sidewalls of the nose are 'turbinates', tissue structures which are rich in blood vessels and glands. often when the septum narrows one side of the nose, it creates a larger space on the other side, into which the turbinate on that side expands. medical management using topical nasal steroid sprays decongests the nasal lining and may lead to improvement in the symptoms of nasal blockage. however, such treatments are required on a daily, ongoing basis and in practice may not be successful. in addition, side effects of nasal dryness, irritation and bleeding may impact on treatment satisfaction and compliance. when surgery to straighten the septum is carried out, some surgeons also reduce the contralateral turbinate tissue. potential complications of septoplasty include septal perforation, septal adhesions and bleeding [4] . post-operative pain is common although this is reduced if sutures rather than nasal packing are used [4] [5] [6] . patients typically are advised to take several days off work or usual activities after the operation. septoplasty has no defined selection criteria, particularly in patients whose principal symptoms are sleep related, and clinical practice varies in different centres. the mode of action of septoplasty in sleep-related breathing disorders is not fully understood [7] [8] [9] . the effectiveness of septoplasty with or without turbinate surgery remains unclear and there is a lack of high-quality evidence of its benefit in the literature [10, 11] . not all patients improve with surgery. estimates of persistent septal deviation following a septoplasty procedure range from less than 6% [12] to 20% [13] . where septoplasty fails and further surgery becomes necessary, revision rates are reported to be high [14] . there is also a lack of robust evidence about the additional benefit of turbinate surgery [11] . one study showed reduced revision rates for septoplasty when the turbinate tissue is reduced [15] ; other studies report no added long-term benefit from turbinate reduction [16] [17] [18] . currently, most septal surgery is based on subjective, unstandardised clinical impressions of the contribution of the nasal septum to patients' symptoms. there is also no good comparative evidence regarding alternatives to septal surgery; nor about who might most benefit, to inform patients' and doctors' shared surgical decisionmaking [11] . whilst it is recognised that that the evidence base for septoplasty is ambiguous [11] , it is important to take into account the variations between men and women in relation to the operation. firstly, septoplasty is more common in men [4, 11] and, secondly, there is a known gender influence on response to nasal-patient reported outcome measures [1] . the aim of nairos is to establish, and inform guidance for, the best management strategy for patients with nasal obstruction associated with a deviated nasal septum, via a randomised controlled trial (rct) of surgery versus medical management across 17 sites in both secondary and tertiary hospitals across england, scotland and wales. to establish, and inform guidance for, the best management strategy for participants with nasal obstruction associated with a deviated septum, via a randomised controlled trial comparing the clinical and costeffectiveness, of nasal septoplasty plus/minus (±) contralateral turbinate reduction versus medical management. the study objectives are split into three different aspects: clinical effectiveness, economic evaluations and mixedmethod process evaluation. clinical effectiveness to measure clinical effectiveness according to: subjective self-report rating of nasal airway obstruction heterogeneity of estimated treatment effect specifically according to severity of obstruction and gender objective measures of nasal patency number of adverse events (aes) and additional interventions required technical failure in the surgical arm how well those agreeing to enter the trial reflect those screened for eligibility the cost-effectiveness of each intervention the cost-utility with outcomes reported as incremental cost per quality adjusted life year (qaly) gained a longer-term economic model to assess costs and health consequences beyond 12-month follow-up period all economic analyses will be conducted from the perspective of the national health service (nhs) and participants mixed-methods process evaluation of the trial and interventions our mixed-method process evaluation will identify, describe, understand and address: barriers to optimal recruitment, and potential solutions to address these, through integration of the quintet recruitment intervention (qri) [19, 20] participants' and healthcare professionals' experiences of trial participation and the interventions under evaluation factors likely to influence wider implementation of trial findings the design, measured outcomes and analysis of the process evaluation and qri are detailed later in this manuscript. a multicentre, randomised controlled, open-label trial, incorporating a qualitative process and economic evaluation. participants will be randomised on a 1:1 basis between septoplasty, with or without turbinate reduction, versus medical management (isotonic saline nasal spray (sterimar) and mometasone nasal spray) of nasal obstruction. participants in the medical management arm will be asked to use the nasal sprays twice daily for 6 weeks, then once daily for the remainder of the 6-month period. recruitment will take place over 20 months, with trial completion complete at 42 months (submission of final report). the trial will take place in 17 nhs hospitals across scotland, england and wales (see the isrctn registry number 16168569). an overview of the nairos schedule of events patient pathway is shown in fig. 1 . adults (aged ≥ 18 years) referred by their general practitioner (gp) to ear, nose and throat (ent) secondary care outpatient clinics who are found to have a deviated septum on nasendoscopy and reduced nasal airway as indicated by a nose score ≥ 30. ent staff will also be recruited for participation in a process evaluation. the nairos eligibility criteria are listed in table 1 . hospital researchers will proactively identify nairoseligible patients through triage of referral letters of rhinology patients to the ent department, and issue an invitation to attend a research clinic. patients attending a research clinic will, where possible, have been sent the patient information sheet (pis) with their appointment details, and have been directed to the patient information video, available at www.nairos.co.uk. all patients will have been given a minimum of 24 h after receiving the pis to decide whether or not they would like to take part. the main pis can be found in additional file 1. consent a delegated member of the research team will undertake informed consent discussions with the opportunity for the patient to ask any questions and discuss the trial in more detail. patients will be invited to give informed, written consent in three stages. firstly, consent to undergo screening (eligibility). secondly, consent to have the discussion about the nairos trial with the investigator audio-recorded and their details passed onto • any prior septal surgery • systemic inflammatory disease or the use of any current oral steroid treatment within the past 2 weeks • granulomatosis with polyangiitis • nasendoscopic evidence of unrelated associated pathology, e.g. adenoid pad, septal perforation, chronic rhinosinusitis indicated by the presence of polyposis or pus • any history of intranasal recreational drug use within the past 6 months • breast-feeding, pregnancy or intended pregnancy for the duration of involvement in the trial • bleeding diathesis • therapeutic anticoagulation (warfarin/novel oral anti-coagulant (noac) therapy) • clinically significant contraindication to general anaesthesia • patients known to be immuno-compromised • those in whom an external bony deformity substantially contributes to the nasal obstruction a member of the qualitative team for a telephone interview. finally, eligible patients are invited to give consent for the main trial, and to also give consent to potential future sharing of their anonymised data with other researchers not related to the nairos study. the patient informed consent form can be found in additional file 2. screening screening data used to assess eligibility will include: clinical examination (including nasal endoscopy) nasal obstruction symptom evaluation scale (nose) scoreconfirmation of total ≥ 30 age baseline recording of four core features at endoscopy of the undecongested nose • the side of the maximum convexity • one main site of deflection on each sideanterior/ posterior/upper/lower/all) • confirmation that there is no excluding inflammatory processpus/polyps/adenoids • magnitude of observer-rated airway block (< 50%; ≥ 50%) if the participant is unable to complete the endoscopic examination without topical preparation, it can be performed after the airway assessment of the decongested nose. the nose scale is a validated five-item, unifactorial self-report of nasal-block severity which has been applied in previous research and audit studies [21, 22] . the three recognised nose-derived categories of baseline severity used will be: 30-50 = moderate, 55-75 = severe, 80-100 = extreme [22] . for nairos, it is anticipated that baseline severity will be the most important determinant of outcome. those with a nose score of less than 30 will be excluded from nairos on the basis of having symptoms that are too mild to warrant inclusion. randomisation at the baseline visit, consenting, eligible patients will be randomised on a 1:1 basis using random permuted blocks of variable length. stratification will be by gender and baseline severity (nose score). randomisation will be administered centrally by the newcastle clinical trials unit (nctu) web-based system. the treatment allocation is open label and the randomisation system will provide a unique trial identifier for each participant via email to a delegated member of site staff. participants will be randomised between: 1. septoplasty with or without unilateral turbinate reduction 2. medical management participants allocated to the septoplasty group will undergo surgical correction of the nasal septal deviation ± unilateral reduction of the inferior turbinate on the concave side. a preliminary secondary care feasibility exercise revealed that there is considerable variation in surgical practice around the uk; rates of contralateral turbinate reduction varied between nairos centres from 30 to 65% of septoplasties. as a pragmatic study, nairos does not ask surgeons to change their usual practice in relation to contralateral turbinate reduction. nairos surgeons may or may not carry out unilateral turbinate surgery on the wider side, according to their assessment of the individual patient airway. intention to reduce one turbinate will be recorded prior to randomisation. details of the actual surgery performed will also be collected. participants will have a closed septoplasty, will be sutured, not packed, and will be a day case (where possible). the recommended post-operative twice-daily regimen will be of saline douche plus naseptin nasal cream (or if the patient is allergic to the peanut content of naseptin, bactroban 2% ointment). participants will be recommended to take a few days off work. nasal-steroid and saline sprays should not be part of routine standard post-operative care for nairos. any additional medication required by participants will be recorded as concomitant medication. surgery must be carried out anytime up to 8 weeks (+ 4 weeks) after randomisation. the additional 4-week window is to allow for extenuating circumstances only, such as unexpected patient or clinical reasons that necessitate a delay in surgery. reasons for delays to surgery will be collected and reported. the surgical intervention will be performed by surgeons who have completed their training. patients randomised to the medical management arm will be asked to use a combination of an isotonic spray with a full twice-daily dose of a fluorinated steroid spray (mometasone furoate) which is a typical maximal medical therapy regime over a 6-month period. preparatory work by the chief investigator indicated that most patients referred from their gp have never used this sustained combination therapy. sterimar isotonic nasal spray dose: one spray (metred dose) into each nostril prior to using the mometasone nasal spray. mometasone nasal spray dose: 100 mcg (two sprays) into each nostril twice daily for 6 weeks, followed by 100 mcg (two sprays) into each nostril once daily or 50 mcg (one spray) into each nostril twice daily for the remainder of the 6-month period. participants who wish to discontinue their allocated treatment, but remain in the trial, may access other treatments via the standard local nhs route. such participants will be followed up as per their allocated treatment intervention arm. participants in the surgical arm who wish to pursue medical treatment will not receive the trial investigational medicinal product (imp) prescription. participants in the medical arm who wish to receive surgery and remain eligible for septoplasty should be added to the elective nhs waiting list. the primary analysis is comparison of the comprehensive, validated sino nasal outcome test-22 (snot-22) [23] patient-reported scores at 6 months from randomisation (− 2 weeks to + 4 weeks), with complete follow-up of participants to 12 months post randomisation. snot-22 is a commonly employed patient reported outcome measure in the assessment of patients with pathologies of the nose and sinuses [23] [24] [25] [26] [27] [28] [29] [30] and was first applied to septoplasty in 2003 [31] . our ppi work found that patient symptoms mapped better to the snot-22 than to the nose and that patients preferred the snot-22 measure. to maximise collection of primary outcome measure, participants who cannot attend the 6-month follow-up visit may complete snot-22 by post. secondary outcome measures can be categorised into patient-reported, safety, economic, exploratory and qualitative. patient reported outcome measures (proms) proms will be used to measure long-term change in nasal patency and quality of life: snot-22 subscales (rhinologic, sleep, ear/facial pain, psychological) at 12 months nose scale at 12 months double ordinal airway subjective scale (doass)administered post nasal decongestant use only at 12 months. doass is a subjective comparator of right and left nasal patency [32] allowing direct comparison with the spirometry measures safety outcomes safety outcomes will be measured by the number and characteristics of any aes, and surgical complication/failure and re-intervention within 12 months. economic outcomes economic outcome measures include: qaly gained using the 36-item short form health survey (sf-36) questionnaire (1-week recall), further converted into qalys using the health economy survey derived from sf-36 (sf-6d) algorithm [33] , at 12 months, and aes avoided use of and timing of additional interventions in primary and secondary care recorded by health care utilisation questionnaire at 6 months and 12 months number of days unable to undertake usual activities recorded by health care utilisation questionnaire at 6 months and at 12 months incremental cost per change in snot-22 at 12 months costs to nhs and participants at 12 months longer-term economic model to assess costs and health consequences beyond the trial exploratory outcome measures two of the most common objective measures of nasal patency, used in some overseas healthcare systems to assess likely benefit from septoplasty, are peak nasal inspiratory flow rate (pnif) and nasal partitioning ratio (npr) [34] . pnif and npr will be used in this trial as exploratory outcome measures. all sites will be provided with two devices to measure two different measurements of nasal patency: pnif, measured with a pnif meter (peak nasal inspiratory flow (pnif) meter; gm instruments, kilwinning, uk) npr, measured using the nv1 rhinospirometer (nv1 rhinospirometer; gm instruments, kilwinning, uk) the two standard measurements will each be made before and after decongesting the nasal turbinate tissue with xylometazoline at baseline and at 6 and 12 months following randomisation. pnif measures the peak flow rate of air through both nostrils during inhalation using a pnif meter with a face mask. the participant holds the mask over the nose and mouth, closes the mouth and inhales maximally (sniffs). pnif has been shown to respond to septoplasty/turbinectomy [35] and can, therefore, be used for an overall assessment of nasal airflow impairment, and as an objective outcome measure from surgery. however, pnif does not differentiate between the two nostrils. bench testing shows the nv1 rhinospirometer to be an accurate and precise objective marker of airflow symmetry [36] . the nv1 rhinospirometer has two separate channels to measure the volume of air passing through each nostril, hence deriving the npr, the difference between right and left volumes divided by the sum. npr ranges from symmetrical (0) to completely unilateral (± 1). the npr appears to predict the septal surgery outcome [34, 37] . comparison of npr during both maximal inhalation and normal tidal breathing will allow the comparative utility of these two measures to be compared and demonstrate any change in nasal function following treatment. qualitative outcomes qualitative outcomes will be identified through observations of training and nairos meetings, interviews with health professionals and participants, and audio-recording of recruitment discussions. the trial schedule of events is presented as a flow diagram (fig. 1 ) and using the standard protocol items: recommendations for interventional trials (spirit) figure [ 38] (fig. 2) . participants recruited to the main trial will be followed up for 12 months from the point of randomisation. data including the number of participants screened, approached and interested in taking part will be collected via a log completed by site staff conducting screening. assessments pre-randomisation eligible patients who consent to participate in the main trial will have the following outcome measures administered prior to randomisation: site nursing staff will record details of any concomitant medication and aes during a phone call at 2 weeks after surgery has taken place, and at all scheduled trial visits. medical management arm data as a pragmatic trial using standard treatment as part of the medical management arm, precise assessment of any mometasone furoate spray and sterimar spray residuum will not take place. participant compliance with the imp does not form part of the trial monitoring plan. participants will be asked at the 6-month follow-up visit (visit 2) to estimate how many bottles of the sterimar and mometasone furoate spray they used. site nursing staff will record details of concomitant medication and any aes during a phone call at 2 weeks post randomisation and at all scheduled trial visits. data will be handled, computerised, stored and archived in accordance with the general data protection regulation (2018), and the latest directive on good clinical practice (gcp) (2005/28/ec). patient-identifiable data will remain at each site and not be collected as part of the trial dataset. patient identification on data collection tools used during screening will be through a unique sequential screening number allocated by site staff. patients recruited to the main trial will additionally be identified by a unique trial identifier number generated by the randomisation system. data will be transcribed and npr files uploaded by site staff to the trial's secure, password-limited, validated macro™ database (elsevier). the participant trial record, including completed paper data collection tools, will be archived at site for 5 years following the end of the trial. audio-recordings will be archived for 10 years. the trial will be conducted in accordance with the medicines for human use (clinical trials) regulations 2004 and subsequent amendments. all parties must abide by these regulations and the international conference on harmonisation-good clinical practice (ich-gcp) guidelines. participants who withdraw their consent from the trial, or are withdrawn by the investigator, will not be replaced. all data collected up until the point of withdrawal will be retained for nairos research purposes, and consent will be sought for this (additional file 2). the snot-22 minimal clinically important difference (mcid) in the national comparative audit of surgery for nasal polyposis and chronic rhinosinusitis was 8.9 [23] . septal surgery is reported variously as showing reductions in total snot-22 scores above (10 points) [29] or below (4 points) this boundary [25] . in the absence of a specific figure for septoplasty mcid, nairos has assumed a clinically relevant reduction being at least 9 points. reported standard deviations (sd) of the snot-22 score were 18 [27] (in external septoplasty) to 24 [28] in septorhinoplasty, nairos assumed the larger, more conservative sd. sample size calculations were based on a t test for superiority assuming equal variance across groups, a conservative estimate given the primary analysis is based on adjustment for stratification covariates, increasing power. the target recruitment of 378 participants allows for 20% drop-outbased upon experience from our unit's two prior septal surgery audits [10, 39] . the remaining 302 participants (151 per arm at completion), are required to show a 9-point [23] difference in overall snot-22 score between arms, with 90% power and 5% type i error, assuming a sd of 24. primary outcome the primary analysis is comparison of snot-22 scores at 6 months by randomised treatment arm (immediate surgery vs medical management). mean overall scores will be presented by treatment group. the associated significance of any observed difference will be calculated in multivariable regression models adjusting any treatment effect by stratification factors, gender and nose severity at baseline. secondary analysis of the primary outcome measure will adjust for the influence of baseline severity snot-22 score as a continuous covariate, planned turbinate reduction as a binary covariate and other important demographic and clinical covariates at randomisation (including, but not exclusively, age, body mass index (bmi), smoking, endoscopic features). non-linear relationships between continuous baseline measures and outcome will be addressed by simple, and possibly more complex, fractional polynomial transformations. the nairos model will generate a linear predictor score of patient outcome weighted according to the statistical importance of each covariate. each patient's linear predictor score will be compared against observed score for internal validation. this model will be used to explore recommendations for treatment options. the importance of baseline severity, as a continuous distribution of nose score at randomisation, may be further explored graphically by subpopulation treatment effect pattern plots (stepp analysis) [40] to display the predicted point estimates of any treatment effect (with 95% ci) over the range of nose values (range 30-100 in nairos participants), further informing any patient selection guidance and recommendations. primary statistical analyses will be carried out on an intention-to-treat basis. the number of ineligible participants and reasons for ineligibility will be reported. a sensitivity analysis may be conducted and reported if the number of ineligible participants or participants not receiving the allocated treatment is excessive. participants may choose to discontinue the treatment to which they have been allocated, and may also ask that they receive an alternative treatment as per local standard nhs care. the implication of such treatment adjustments, which typifies surgical trials, is that the intention-to-treat analysis will produce a conservative estimate of the effect of septoplasty. non-compliance (including receiving the alternative treatment) may be addressed using an 'as treated' approach or complier average causal effect (cace) approach, since the intention-to-treat analysis under noncompliance is biased when the intervention effect is large [41] . statistical methods for withdrawal of participants, based on statistical censoring, may be considered. tests of heterogeneity will assess robustness of the overall treatment effect across stratification subgroups, and by intention to perform unilateral turbinate reduction. there are no formal interim analyses of the primary outcome measure and there are no formal statistical stopping rules. decisions regarding continuation of the trial will be made at dmc meetings held every 6 months. decisions will be made on the basis of information presented in a statistical report that includes analysis of formal data snapshots, including safety data. analysis of secondary outcomes analyses of secondary outcomes will follow a broadly similar strategy. these will include the data at 6-month follow-up from the other outcomes (snot-22 subscales, nose, doass, sf-36) and that for all outcomes at 12-month follow-up. subjective scales, tabulated by arm and overall at randomisation, 6-month and 12-month follow-ups, will be compared by both summary statistics and graphical representation. multiple regression will be used to investigate longitudinal outcome scores between treatment groups at follow-up time points. variation between participants will be included as a random effect with an assumed normal distribution. analysis will include the stratification factors of baseline severity and gender. further adjusted analyses will include terms for baseline values of the scores and key demographic and clinical covariates. adverse events will be tabulated according to world health organisation (who) common terminology criteria for adverse events (ctcae) grade version 4.03. number of severe (ctc grade 3, 4 or 5) will be reported as a proportion of all aes. number of participants experiencing at least one severe ctcae will be reported as a proportion of all participants. surgical complication/failure and re-intervention will be tabulated and will not subject to statistical testing. technical failures from operations where widening of nasal airway was achieved yet the symptoms persist will be reported. analysis of exploratory outcomes three measurements each of pnif and npr during maximal inhalation will be made. either the maximum (pnif) or average (npr) value is used. summary statistics will be presented for pnif and npr by arm and overall, at baseline, 6-month and 12month follow-ups. design the process evaluation incorporates the qri and mixed qualitative methods. data collection and analysis will commence during study set-up and continue throughout the trial. randomising patients between surgical and medical arms can be challenging. the qri, based at bristol university, will assist in the identification and methods of addressing such challenges. the qri uses novel qualitative and mixed-method approaches pioneered during the national institute for health research (nihr) health technology assessment (hta)-funded protect (prostate testing for cancer and treatment) study [42] . these methods have since been applied to several other 'challenging' or controversial rcts in different clinical contexts, all of which have led to insights about recruitment issues and the development of generic and bespoke strategies to optimise recruitment [43] . the qri will coincide with the study set-up and the first year of recruitment, using qualitative and novel methods to investigate and address recruitment barriers (objective a, below) [43] [44] [45] . qualitative interviews will be conducted throughout the trial to investigate patients' and clinicians' experiences of the study procedures, interventions and barriers to implementing findings into practice (objectives b and c, below). sampling strategy the sampling strategy is informed by current and prior experience [42, 46, 47] . in keeping with the principles of rigorous qualitative research, sampling will be responsive to the study context. in some cases fewer interviews or observations will be conducted, and in others, additional data will be required to accommodate our emerging analysis or study events. numbers of interviews will be guided by 'data saturation'continued sampling until findings become repetitious. objective a: optimising recruitment -qri (study set-up and first year of recruitment) working in close collaboration with the trial management group (tmg), the qri team will assimilate investigational and interventional approaches to understand and address recruitment difficulties in the early stages of nairos. the findings and implications of the qri will continue to be implemented by the tmg and study investigators throughout the remainder of the trial recruitment period. the qri will proceed in two iterative phases: a detailed understanding of the recruitment process will be developed in phase i, leading to tailored interventions to improve recruitment in phase ii. phase i: understanding the recruitment process and how it operates in individual centres. a multi-faceted, flexible approach will be adopted, comprising one or more of the following methods: (a) in-depth interviews, conducted with: members of the tmg (n = 5-10); clinicians or researchers involved in trial recruitment (n = 10-12); and eligible patients who have been approached to participate in the trial (n = 5-10). interviews will explore views on trial processes, perceptions of equipoise, and information about how the protocol is operationalised in clinical centres (b) audio-recording and non-participant observation of consultations during which the trial is discussed with patients, enabling identification of clear and subtle obstacles to recruitment (c) mapping of eligibility and recruitment pathwaysnoting the point at which patients receive information about the trial, which members of the clinical team they meet, and the timing and frequency of appointments. the qri researcher will work closely with the clinical trials unit to compose logs of potential rct participants as they proceed through screening and eligibility phases (d) regular observation of tmg and investigator meetings to gain an overview of trial conduct and overarching challenges (logistical issues, etc.) (e) scrutiny of study documentation (e.g. piss) to identify aspects that are unclear or potentially open to misinterpretation phase 2: development and implementation of recruitment strategies. anonymised findings from phase i will be presented to the tmg, summarising the factors that appear to be hindering recruitment. a plan of action will be devised in collaboration with the tmg if there is consensus that aspects of practice are amenable to change. interventions will be tailored to the nature of recruitment challenges identified. generic forms of intervention may include 'tips' documents on how to explain trial design and processes. supportive feedback will be a core component of the plan of action, with the exact nature and timing of feedback dependent on the issues that arise. centre-specific feedback may cover institutional barriers, whilst multicentre group feedback sessions may address widespread challenges. individual confidential feedback will be offered where there is a need to discuss specific challenges or potentially sensitive issues. objectives b and c: understanding experiences of septoplasty and non-surgical management we will investigate patients' (n = [16] [17] [18] [19] [20] and health professionals' (n = 16-20) experiences of the interventions and trial participation through qualitative interviews conducted during patient follow-up. where possible, patients for the follow-up interviews will include those interviewed during the recruitment phase; additional participants will be recruited based on purposive and emergent criteria (e.g. patients who have declined their allocated treatment). we will identify any aspects of the care pathway which are problematic for patients or health professionals; and potential barriers and facilitators to wider acceptance and implementation of trial findings. a focus group of gps will explore preliminary trial findings and discuss implications for primary care management of nasal obstruction. our analysis of the implementation of study findings will be informed by normalisation process theory (npt) [48] . qualitative data management and analysis all interviews will be audio-recorded, transcribed verbatim and edited to ensure anonymity of respondents. contemporaneous field notes from non-participant observation in clinical settings will be edited to ensure anonymity of participants. data will be managed using nvivo software. the analysis will be conducted according to the standard procedures of rigorous qualitative analysis which we have described previously [49] , including open and focussed coding, constant comparison [50] , memoing [50] , deviant case analysis [51] and mapping [52] . we will undertake independent coding and crosschecking and a proportion of data will be analysed collectively in 'data clinics' where the research team share and exchange interpretations of key issues emerging from the data. audio-recorded recruitment consultations will be subjected to content, thematic and novel analytical approaches, including targeted conversation analysis [52] and quanti-qual appointment timing (the 'q-qat method') [53] . there will be a focus on aspects of information provision that is unclear, disrupted, or potentially detrimental to recruitment and informed consent. all participants who complete the nairos trial, or who discontinue the treatment interventions at any point, will be offered standard, local nhs care in discussion with their local investigator. the sponsor will provide indemnity in the event that trial participants suffer negligent harm due to the management of the trial. this indemnity will be provided under the nhs indemnity arrangements for clinical negligence claims in the nhs. the trial steering committee (tsc), data monitoring committee (dmc), trial statistician, data manager and other members of the central trial team as required will have access to the full trial dataset. individual site trial datasets will not be available to individual site investigators prior to publication of the main trial results. all requests for data should be directed to the corresponding author for consideration. access to the anonymised final trial dataset may be available following review; we will retain exclusive use until publication of major outputs. the results of the trial will be presented at topic-specific national or international conferences and published in a general medical journal with the monograph published by hta. authorship of all publications will be on a named individual authorship basis. for each publication, all individuals who fulfil the authorship definition for the publishing journal or site will be included as individually named authors. authorship order will be decided by the chief investigator and tmg. a lay summary of results and the hta report will be available on the nairos website. members of the patient and public involvement (ppi) panel will review results and they will be involved in writing lay summaries of results for dissemination to relevant patient groups. nctu staff will monitor trial conduct and data integrity to ensure that the trial is conducted in accordance to the latest directive on gcp (2005/28/ec). this will be detailed in a data management plan and a monitoring plan approved by the trial sponsor. safety reporting delegated nursing staff will interview participants to collect and record any aes. this will take place at every trial visit (n = 3), and also via safety phone calls; 2 weeks after randomisation for medical management arm participants, and 2 weeks after septoplasty for surgical arm participants. serious adverse events (saes) will be assessed for any relationship to the treatment intervention (causality), and expectedness (by reference to the reference safety information (rsi)) of any serious adverse reactions (sars). only a qualified medical doctor, delegated to do so at site, may assess the causality and expectedness of each sae. trial management group a trial management group, facilitated by nctu, will convene approximately monthly throughout the duration of the trial. members will consist of key nctu staff, the chief investigator, local clinical co-applicants, trial statisticians, a sponsor representative and staff representing health economics, qualitative and quintet recruitment intervention teams. independent data monitoring committee an independent data monitoring committee (dmc) has been appointed to provide an independent review of participant safety and data endpoints. the independent members comprise two statisticians and a clinician. the dmc will meet at least annually, and report directly to the trial steering committee (tsc). trial steering committee a tsc has been appointed to provide overall independent supervision of the trial. members consist of an independent chair, two independent clinicians, an independent statistician, an independent health economist and three patient representatives. the tsc will meet least annually, after a dmc meeting. all substantial changes to the protocol were approved by the local uk hra research ethics committee, and standalone minor changes (version 4.1) were approved by the health research authority (hra), prior to implementation at sites. the current, full protocol is available to view on the trial funder's website: https://fundingawards.nihr.ac.uk/search. a summary of key changes to the protocol during the trial is listed in table 2 . there is a paucity of evidence underlying the indications for septoplasty in the uk. at present, the decision to perform septoplasty is based on the clinician's subjective estimation of the impact on the affected nasal airway caused by a deviated septum. in addition, there is a lack of evidence of the impact of a standardised topical medical treatment regimen on the nasal airway in the presence of a septal deflection. at a time of rising healthcare costs and increasing scrutiny on the requirement to justify clinical interventions there is an urgent need to answer these questions. the aim of nairos is to perform a rct to compare surgical treatment to a standardised dual medical therapy (sterimar spray and mometasone spray) and estimate the effectiveness based on subjective nasal symptoms, objective airway measurements and the impact on quality of life. furthermore, a number of other interactions will be measured at baseline, 6 and 12 months following randomisation. the impact of known covariates including sex, turbinate enlargement and subjective degree of nasal obstruction will be assessed. nairos is a pragmatic 'real-world' trial, researching a common surgical intervention against a contemporary comparator in such a way that the results will be generalisable to nhs patients in whom it is offered. however, limitations are anticipated in both treatment arms. in the surgical arm clinicians may vary in their assessment and documentation of the nasal septum deflection. it is also recognised that there are shortcomings in objective measurements of the nasal airway [54] . in the medical arm we are not monitoring quantities of nasal-steroid used and instead relying on patientreported use. nairos will also compare the cost-effectiveness, to the patient and the nhs, of both the medical and surgical arms of the trial. the challenges and barriers to patient recruitment will be analysed by the quintet recruitment intervention with a view to identifying and minimising these. a qualitative evaluation will explore the views of participants and staff and their experience of the intervention to enable us to shape guidelines and inform clinical decision-making in patients with a deviated nasal septum. the overarching aim will be to shape future guidance on the management of a deviated nasal septum in an nhs setting. the nairos trial is currently working to protocol version 5.0, dated 16 january 2019. recruitment began on 18 january 2018, and is due to end on 31 january 2020. supplementary information accompanies this paper at https://doi.org/10. 1186/s13063-020-4081-1. • specification of the location of the rsi within the mometasone smpc 3.0, 20 nov 2017 • specification of the decongestant spray to be used alongside the nasal patency measurements (xylometazoline) and classification of the decongestant spray as a nimp • clarification of the exclusion criteria regarding the use of orally administered steroids and updating the exclusion criteria to exclude patients who have an external bony deformity that is likely to make a substantial contribution to the nasal obstruction 4.0, 11 jun 2018 • update to the mometasone rsi • update the exclusion criteria from any history of intranasally administered recreational drug use to any history of intranasal recreational drug use within the past 6 months • clarify the clinical examination procedure to state that patients who request local anaesthetic for nasal endoscopy may have the nasal endoscopy assessment carried out after the other trial assessments have been completed • clarification of the timing for the surgical intervention to state that patients randomised to septoplasty must have their septoplasty anytime within 8 weeks of randomisation 4.1, 21 dec 2018 addition of a 4-week window to the timeline for surgery for use in extenuating circumstances (i.e. 8 weeks + 4 weeks) • change the window for the 6-month visit from ± 2 weeks to − 2 weeks/+ 4 weeks to maximise collection of the primary outcome measure • clarification of management of patients between the 6-month and 12-month follow-up visits • clarification of management and options for participants who wish to discontinue with their allocated treatment and explore other surgical or medical treatments as part of standard nhs care • state that discontinuation of allocated treatment does not constitute withdrawal from the trial. update to the rsi for the surgical intervention ambulatory sinus and nasal surgery in the