listen to our podcast trilotalk! available on apple podcasts, google podcasts, and spotify do you want to make a change as a medical writer? visit us at trilogywriting.com writers@trilogywriting.com www.trilogywriting.com/trilotalk where was it written that medical writing had to be dry, mediocre or uninspiring? sadly, it was everywhere we looked. in regulatory reports duller than butter knives. in poorly summarized summations. subpar medical writing was everywhere and spreading. so we did something about it. we waged war against mediocrity to make a change. think you have what it takes to join a world-leading team of medical writers? we’d love to speak with you. https://www.trilogywriting.com/ listen to our podcast trilotalk! available on apple podcasts, google podcasts, and spotify do you want to make a change as a medical writer? visit us at trilogywriting.com writers@trilogywriting.com www.trilogywriting.com/trilotalk where was it written that medical writing had to be dry, mediocre or uninspiring? sadly, it was everywhere we looked. in regulatory reports duller than butter knives. in poorly summarized summations. subpar medical writing was everywhere and spreading. so we did something about it. we waged war against mediocrity to make a change. think you have what it takes to join a world-leading team of medical writers? we’d love to speak with you. mailto:writers@trilogywriting.com http://www.trilogywriting.com/trilotalk http://www.trilogywriting.com 120 amwa journal / v36 n3 / 2021 / amwa.org • need to write invoices and receipts (i use the time tracker harvest for this) • have multiple people using the same business bank account • have regular employees or subcontractors when i transitioned from nonprofit work to freelancing, the minimum payment of $25/month seemed exorbitant. quicken (i pay $3/month) does the following for me: • automatically enters transactions from my bank accounts • categorizes my income and expenses • handles my business and personal accounts side-by-side • streamlines reporting for taxes • makes it easy to observe trends in my business and analyze development efforts (reports are very user friendly) i started with my tax lady’s worksheet when setting up my categories; each line item she requests becomes a category. this ensures that i can write off as many business expenses as possible. i also track some categories for my family, such as eating out (way down this fiscal year!). a few more things to consider: • make sure the software will sync with your specific bank. • i have not found the budgeting features very intuitive in either quicken or quickbooks. • it takes me about 15 minutes per month to review the transactions uploaded in quicken and make sure everything has been categorized properly. • at tax time, it takes no more than 45 minutes to report everything accurately. my tax lady gives me a discount for turning in my information early. this discount more than pays for the annual price of quicken! — allie boman freelance focus international society of managing and technical editors october 11-14, 2021 virtual https://www.ismte.org/page/conferences regulatory affairs professionals society september 12-15, 2021 virtual https://www.raps.org/regulatory-convergence national association of science writers october 8-11, 2021 boulder, colorado, and virtual https://www.nasw.org/events international conference on communication in healthcare october 17-20, 2021 virtual https://achonline.org/icch2021 american public health association october 24-27, 2021 denver, colorado, and virtual https://www.apha.org/events-and-meetings/annual amwa medical writing & communication conference october 27-29, 2021 virtual www.amwa.org/conference european medical writers association november 4-6, 2021 london, england, and virtual https://www.emwa.org/conferences/future-conferences/ alliance for continuing education in the health professions january 12-15, 2022 aurora, colorado http://www.acehp.org/p/cm/ld/fid=570 american association for the advancement of science february 17-20, 2022 philadelphia, pennsylvania, and virtual https://meetings.aaas.org/ dia europe 2022 march 29-31, 2022 brussels, belgium, and virtual https://www.diaglobal.org/en/flagship/dia-europe-2022 calendar of meetings please confirm with individual meeting hosts www.amwa.org/conference 2021 amwa medical writing & communication conference october 27-29, 2021 coming to a device near you trends and opportunities for medical communicators http://www.amwa.org/conference https://www.ismte.org/page/conferences https://www.raps.org/regulatory-convergence https://www.nasw.org/events https://achonline.org/icch2021 https://www.apha.org/events-and-meetings/annual http://www.amwa.org/conference https://www.emwa.org/conferences/future-conferences/ http://www.acehp.org/p/cm/ld/fid=570 https://meetings.aaas.org/ https://www.diaglobal.org/en/flagship/dia-europe-2022 v37 n2 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 48 conference the global challenges of the past 2 years have resulted in a myriad of changes in our personal and professional lives. as the world begins to recommence, medical communicators will again be called to elevate health and aid in crafting messages that promote well-being both in ourselves and others. #amwa2022 marks a return to in-person conference activities. the 2022 medical writing and communication conference will be held november 2-5, 2022, in denver, colorado. the resiliency and commitment of the amwa community will be on full display in denver as we once again are able to learn and connect face-to-face. public health guidance and local event best practices will be followed during the conference. it is our top priority to create the safest possible environment, and we will do this by proceeding with the current best practices and information available to us. we are continuing to review and evaluate the outlook for in-person events and will provide updates as they become available. as we get closer to the event, we will post more information about what you can expect on-site. member feedback has consistently praised the connection and development opportunities at the medical writing and communication conference, and we are working hard to ensure this warm and welcoming learning environment is present at #amwa2022. educational sessions will feature topics chosen to meet the current professional development needs of attendees presented as interactive workshops, presentations, panel discussions, and small-group roundtables. plenary sessions will highlight trend-setting topics in medical communication and honor the accomplishments of kimberly korwek, phd / chair, annual conference program committee resiliency on display in denver: amwa 2022 medical writing & communication conference left: morrison red rocks park ten miles west of denver. right: denver's big blue bear sculpture by lawrence argent peering into the convention center. amwa members and other influential medical communicators. networking will be plentiful with opportunities for members to reunite and make new connections. the conference location in beautiful denver, colorado will also provide attendees with plenty of options for extramural activities. denver features one of the most walkable downtowns in the nation and 300 days of sunshine per year, which makes it a great location for partaking in the multitude of top restaurants and craft breweries. art galleries and history museums also call downtown denver home, as do many amazing coffee shops. the surrounding area with 200,000 acres of parks in the nearby mountains will tempt you to extend your stay and explore! ➔ registration is now open for the 2022 medical writers and communication conference. join your colleagues in denver to learn, connect, and reinvigorate your professional and personal development! join us in denver! http://www.amwajournal.org https://www.amwa.org/event/2022annualconf v37 n3 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 39 amwa fellowships are awarded to members who have made significant contributions to the goals and activities of amwa. the 2022 fellows are leaders with distinguished records of service at the chapter and national levels. loretta bohn loretta bohn, els, is a senior editor/ writer at rti international, an independent, nonprofit research institute, where her current assignments concentrate in behavioral health and criminal justice. a communication specialist with 30 years of experience in editing, writing, and proofreading, she focuses on developing relationships with authors and on mentoring newer editors. trained as a schoolteacher, she has taught writing and editing workshops for both amwa and rti. in her nonwork hours, loretta runs a household for the comfort and convenience of her 2 cats, volunteers in various capacities at church, and is learning to garden. erica goodoff erica goodoff is a senior scientific editor in the research medical library at the university of texas md anderson cancer center, where she has worked for the past 11 years. she began her career at a publishing house, where she started as a proofreader and then became a managing editor of several life science journals. erica attained the editor in the life sciences certification in 2010 and earned diplomate status in 2020. in her current role, she spends most of her time substantively editing research papers and grant proposals, as well as periodically presenting workshops and training sessions for her clients on how to write these documents. she is also the leader of her group’s editing internship program, in which she recruits, supervises, and mentors future editors. erica has been an active member of amwa for 11 years. she has volunteered for the southwest chapter board of directors since 2013 and has served as treasurer of the southwest chapter since 2016. she has presented various open sessions, roundtables, and webinars on editing and professional development topics at both the chapter and national levels. erica is currently a member of the annual conference committee and teaches the essentials of copyediting workshop. gail v. flores gail v. flores is a freelance medical writer who specializes in the development of educational materials for pharmaceutical and biotechnology sales representatives in oncology. gail’s favorite parts of doing her phd thesis research in a drosophila lab at ucla was learning how to develop publications and presentation materials that effectively and clearly communicated the results or her experiments and reading and hearing about novel research being conducted in other labs around the world. she started working as a science writer in 2000, joined amwa in 2001, and shortly thereafter launched her medical writing business, encore biomedical communications llc. after participating in the leadership of the pacific southwest chapter for 11 years, gail joined amwa’s national leadership in 2016, had the honor of leading amwa as president in 2020–2021, and currently serves as amwa immediate past president. over the years, gail has been a member or chair of several amwa committees and task forces, presented at chapter events and annual conferences, co-authored position statements and press releases for amwa, and contributed to the amwa journal. gail is passionate about the craft of medical writing and values the important role medical communicators play in today’s world; she also treasures the friends, professional connections, and welcoming community that awma has provided. please join amwa in congratulating loretta, erica, and gail. they will be acknowledged at the 2022 medical writing & communication conference, to be held in denver, co from november 2–5, 2022. the member awards committee members were melissa l. bogen, elizabeth brown, sarah dobney (chair), mary knatterud, susan krug (ex officio), abbie roth, and michael schneir. diane noland from amwa hq provided excellent support. sarah dobney / 2021–2022 director-at-large and chair, member awards committee amwa fellowships amwa news http://www.amwajournal.org v37 n2 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 3 medicine, holding ourselves to high ethical standards, being mindful of potential personal biases while relentlessly striving toward objectivity, and ensuring our written contributions are always clear, precise, and complete. this applies whether our audience is a medical researcher or practitioner, student, regulatory body, patient, or the public at large. in recognition of the growing importance of our role as medical communicators in conveying factual scientific information to our varied audiences, the theme for the summer 2022 issue of amwa journal is communicating science. in this issue, we tackle several topics relevant to our role in communicating science to our audiences, including • the value of generating plain language summaries of scientific publications to help patients and other nonspecialists to understand the potential implications of clinical and medical research, • the making of good lay summary practice guidance to help the public understand the results of clinical trials, and • a proposed systematic approach to writing a scientific manuscript to increase the likelihood it will be used to further advance biomedical knowledge. we are hopeful you will find the information in this issue helpful to you in your ongoing role in communicating science. reference 1. bornmann l, haunschild r, mutz r. growth rates of modern science: a latent piecewise growth curve approach to model publication numbers from established and new literature databases. humanit soc sci commun. 2021;8(224):1-15. https://doi.org/10.1057/s41599-021-00903-w communicating science michael g. baker, phd, editor-in-chief and thomas m. schindler, phd, guest editor these are good times to be a medical communicator! science keeps growing and so does the number of scientific publications. in the life sciences, the number of publications increases over 5% every year and the total number of publications doubles every 14 years.1 this reflects the growing number of scientific articles intended for fellow scientists and peers. with the increasing involvement of medical writers in the preparation of manuscripts, this growth provides a multitude of opportunities for professional medical communicators. thus, medical writers are part of a larger voice of researchers, medical practitioners, educators, and journalists who are conveying advancements clearly and objectively. the audience many medical writers may primarily serve is the scientific/medical community. however, there is a growing demand of society at large and of patients in particular that the science they support with their taxes and with their out-of-pocket expenses is explained to them. they want to know what scientists work on and what relevance their work has. they want to understand why a new drug that comes at a higher price is apparently better than established cheaper products. with the growing demand of informing nonspecialists and the public comes an additional responsibility for medical communicators. we need to continue finding and defining best practices in communicating science to nonexpert audiences. although science is growing, there is a concerning percentage of society that mistrusts scientific expertise. bubbles have emerged in which misinformation is spread, and opinions are presented as facts, particularly via social media. in this situation, medical communicators need to lend themselves to the struggle for objective and honest content and presentation. communicating to the public needs to be embedded in a framework of sound ethical principles. at a practical level, as medical communicators, we must continue to do our part by valuing the scientific method as the path toward advancements in our understanding of michael g baker, phd editor-in-chief thomas m. schindler, phd guest editor from the editor & guest editor http://www.amwajournal.org https://doi.org/10.1057/s41599-021-00903-w contents v35 n3 fall 2020 150 138 122 research survey results: impact of the covid-19 pandemic on medical communicators � ann winter-vann and cynthia l. kryder research editing by the book: lessons from technical editing texts � tom lang feature science series sepsis and septic shock: knowns and known unknowns � paul c. dolber sounding board two easy, essential proscriptions in the covid-19 era: locking down clarity and respect � mary e. knatterud practical matters free advice for freelancers: become the medical writer your client needs � jen limarzi freelance focus brian bass, lori de milto, cathryn d. evans, gail v. flores, and phyllis minick what do you feel will be the long-term consequences for freelancers as a result of coronavirus disease 2019 (covid-19)? have you had to implement measures to bolster your income until corporate clients adjust to the effects of covid-19? what are some changes or trends that you have seen in your freelance business opportunities as projects are delayed/ postponed/reworked? around the career block the rise of the messy cv: are life sciences companies finally starting to value professionals with diverse and nontraditional career paths? � rosalie harrison calendar of meetings reprint catching the wave of lifestyle medicine � maria carolina rojido 111 115 122 129 131 133 136 137 138 contents editor james r. cozzarin, els, mwc managing editor jennifer workman section editors around the career block lauren mcmahon, pharmd media and technology tara ann cartwright, phd practical matters qing zhou, phd, els regulatory insights jennifer bridgers, ms, mwc science series paul c. dolber, phd social media jennifer minarcik, ms statistically speaking thomas m. schindler, phd everyday ethics julie ravo, ba, ma members matters govindi (jaya) samaranayake, phd regular contributors freelance focus ruwaida vakil, msc brian bass, mwc melissa l. bogen, els sherri bowen, ma, els lori de milto, mj cathryn d. evans gail v. flores, phd phyllis minick in the service of good writing laurie endicott thomas, ma, els editor at large haifa kassis, md editor emeritus lori l. alexander, mtpw, els, mwc editor in memoriam ronald j. sanchez 2019–2020 president ann winter-vann, phd 2019–2020 board liaison/ at-large director r. michelle sauer gehring, phd, els, cra 2019–2020 staff liaison shari rager, ms, cae executive director susan krug, ms, cae graphic designer amy boches, biographics editorial office: managingeditor@amwa.org. instructions for authors available at: www.amwa.org/journal. advertising: contact marketing@amwa.org or (240) 239-0940. all advertising is subject to acceptance by amwa and should be for products and services relevant to professional medical communicators. amwa is not responsible for the content of advertising and does not endorse any advertiser or its products or services. subscription: the amwa journal is published quarterly. subscription is included with amwa membership. nonmember subscriptions cost is $75 per year. contact: american medical writers association, 30 west gude drive, #525, rockville, md 20850-4347. phone: (240) 238-0940; fax: (301) 294-9006; email: amwa@amwa.org. the amwa journal is in the mla international bibliography and selectively indexed in the cumulative index to nursing and allied health literature (cinahl) print index and the cinahl database. the opinions expressed by authors contributing to the journal do not necessarily reflect the opinions of amwa or the institutions with which the authors are affiliated. the association accepts no responsibility for the opinions expressed by contributors to the journal. ©2020 american medical writers association. all rights reserved, worldwide. issn 1075-6361 amwa journal mission statement in support of the mission of the american medical writers association (amwa) and to advance the broader profession, the amwa journal publishes content that reflects the interests, concerns, and expertise of medical communicators. its purpose is to inform, inspire, and motivate medical communicators. m o r e v35 n3 / 2020 145 creative writings overhead:"code blue at nursing station 2! intubation!" � jodi-ann edwards 146 in the service of good writing choose the right verb, and don’t smother it � laurie endicott thomas 148 conference preview coming to a device near you—amwa’s first ever virtual annual conference � elise eller 149 2020 mcgovern award recipient: lisa sanders, md, facp � ann winter-vann 150 2020 president’s award recipient: joan affleck, mba, els � ann winter-vann 150 amwa names fellows for 2020 � karen potvin klein 152 amwa news from the president � ann winter-vann slate of candidates for 2020–2021 election � gail v. flores amwa education at your fingertips � lori l. alexander 157 instructions for contributors mailto:managingeditor@amwa.org http://www.amwa.org/journal mailto:marketing@amwa.org mailto:amwa@amwa.org amwajournal.org 22session reports sales training and beyond: developing educational content across the pharma/ biotech landscape speakers gail v. flores, phd, medical writer, encore biomedical communications llc, encinitas, ca lauren mays weddle, phd, learning strategist and senior medical director, curtis learning llc, philadelphia, pa julie munden, ba, director of editorial services, curtis learning llc, philadelphia, pa by kavita garg, mpharm gail v. flores, lauren mays weddle, and julie munden, speakers at the 2021 american medical writers association (amwa) medical writing & communication conference, discussed the elements (who, what, and how) of sales training materials, debunked some misconceptions about them, and revealed insights into what it’s like to work in this field. their goal was to bring awareness to an unmet need in the amwa community by providing medical communicators with the skills required to work in sales training for the biotech and pharma industries. busting common myths dr flores described the field of sales training as being a black box that remains unopened. she addressed some misconceptions about what developing sales training materials entails. who (key stakeholders, their roles, and processes involved) dr mays weddle introduced the key players for the sales education and training materials that medical writers (mws) create (from both the client and agency sides). the procedures involved in developing collaborative concepts for a variety of target audiences with different learning needs are discussed below. the key role players are project leads, writers, and editors. key stakeholders audience • medical affairs, sales, clinical nurse educators, patient services, patients, health care providers training for commercial sales representatives • adult learners • educational background varies • years of commercial sales experience varies client team main point of contact • commercial training manager or director • lead initiatives team involved in reviewing materials • marketing • medical • legal • regulatory sales training team (curtis learning llc) main point of contact • learning strategist • medical director • project manager content development team • medical writer • medical editor • content manager • medical illustrator • graphic designer • fact-checkers • technical team http://www.amwajournal.org amwajournal.org 23session reports curriculum design and development bringing therapy to market is a multi-year process around united states food and drug administration (fda) approval, so the training materials in the curriculum supporting the product (client’s drug) launch typically cover a range of topics. 1. prelaunch a. foundational training b. disease state, treatment landscape, and product knowledge 2. launch a. launch training/workshops b. certification 3. postlaunch a. ongoing support for existing indication b. new foundational and launch curriculum for additional indications what (types of deliverables for sales training) dr flores also highlighted becoming familiar with a variety of print and digital deliverables that includes medical illustrations for their sales-trained clientele. 1. prelaunch (print or digital modules, assessments, patient cases, quick reference cards, interactive deep dives, subject matter expert-facilitated sessions) 2. launch a. launch training/workshops b. annotated package inserts c. certification 3. postlaunch a. update of previous materials b. resources to address knowledge or skill gaps dr flores contrasted and explained how sales training in medical writing differs from other types of medical writing. similarities: deliverables most commonly include an outline and 3 drafts, working templates, medical editing, and graphic design, elements of storytelling, and adherence to strict citation guidelines, and referencing of every statement to the publication page. although not ideal, many projects also have some out-of-scope work due to late reviews and changing therapeutic landscapes. differences: for sales training materials, the mw decides how to present content (bulleted lists, tables, medical illustrations, graphics, or infographics), collaborates with medical illustrators and artists, writes customized glossary definitions for terms the learner may not be familiar with, and writes for real-world application. how (key steps in deliverable development) munden summarized the key steps in the deliverable development process. it’s important to understand them to grasp their significance and what happens when these deliverables are used in the field. 1. content outline (mw, client) 2. draft 1 (mw) 3. draft 2 (mw, review, edited, and fact-checked by medical editor, uploaded into client’s content management system by a content manager) 4. medical/legal/regulatory (mlr) reviews all deliverables for approvals and resolves comments 5. additional drafts—resolve mlr comments, layout finalization, re-upload by content manager 6. document approval—incorporate any changes in the layout, comments resolution, deliverables ready for use all documents—outline and all drafts—are fully annotated and internally edited and reviewed before submitting to the client. key takeaways knowing the essential people and processes involved in sales training content development, as well as how to collaborate effectively throughout content development, is necessary when writing for sales training audiences. medical writing for sales training focuses on scientific and clinical education. from early conception through final approval and dissemination, generating sales training materials requires various key steps. kavita garg is director-medical writing at saliegral global pvt ltd. and is based in singapore. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest concerning this article. author contact: kavita.garg@saliegral.com * * * http://www.amwajournal.org amwajournal.org 24session reports teaching the next generation of regulatory medical writers speakers kim jochman, phd, rac, director, medical writing, merck & co., inc, rahway, nj marsha caton-faustin, phd, director, oncology medical writing, merck & co., inc, rahway, nj by kavita garg, mpharm general session overview the speakers at the 2021 american medical writers association (amwa) medical writing and communication conference, kim jochman and marsha caton-faustin, discussed the importance of having standardized regulatory medical writing (mw) training programs, with a focus on the need for structured training programs for entry-level and early-career regulatory mws. the speakers also discussed how their organization adapted and implemented industry-level guidelines to develop training programs for new regulatory writers. sharing this approach can help other organizations train new regulatory mws and provide them with all of the essential skills required for performing this job. why do we need a training program for regulatory writers? caton-faustin explained why organizations need a standardized training program for regulatory writers. people generally envision writers sitting at their desks, pounding away at the keyboard, and completing writing chores, especially in a regulatory or scientific writing career. most people with scientific degrees know how to write and present scientific data, but how many of them have had one-on-one coaching from a mentor or coach to bridge the gap between academic writing and regulatory writing? how many writers were given no guidance at all and learned to write regulatory documents by trial and error or by sink or swim? a regulatory or scientific writer, whether working for a sponsor organization, a contract research organization, or a medical agency, works with cross-functional teams, manages multiple projects, and juggles a lot on daily basis, all while completing their writing tasks. many organizations do not provide formal training to their writers, and experienced writers have a varied baseline experience. looking at the landscape of regulatory writing, it is important to provide mws with thorough training so that they understand what they’re entering into and what they’ll be required to do in this dynamic profession. developing skills in regulatory writing takes a long time. it’s tough to create a training program that fits all writers because of the wide range of regulatory documents and leadership skills. developing a structured training program jochman shared some of the resources that can be used to provide some guidance—the dia’s medical writing competency model and the amwa recommended training outline for regulatory writers (table 1). table 1. brief overview of industry-level guidance available industry-level guidance dia medical writing competency model (2018)1,2 amwa recommended training outline for regulatory writers (2020)3 • focuses on professional medical writing within the life sciences industry. • the working group consisted of experts from multiple companies, medical writing specialties, and industry sectors. • based on dia competency model (especially section 2) and experience of amwa workforce training committee. consists of 2 sections 1) core work functions divided into functions, tasks, and activities: a) core role delivery eg, document preparation, development, and finalization 2) knowledge and skills to successfully perform these functions for all mws, regulatory mws, and mw managers a) knowledge at different levels b) skills and abilities c) behaviors 3) does not distinguish competencies of novice mws from experienced mws consists of 1) list of recommended training topics and priorities for training, from entry-level to more advanced levels a) core knowledge and skills i) drug development process ii) medical writing skills iii) technical aptitude iv) analytical skills b) documents (3 levels) c) soft skills i) management skills ii) personal development 2) list of independent reading for regulatory mws 3) customizable training checklist template http://www.amwajournal.org amwajournal.org 25session reports jochman also talked about how their company used these guidelines to develop rotational training programs for entry-level mws (table 2). caton-faustin discussed their early-career development program, designed for employees from varied backgrounds, including those who have finished the entry-level mw program as well as those who have come in from other organizations or even different departments within their own company (figure). key takeaways in summary, a mw training program provides the foundation for entry-level and early-career writers to succeed in their careers. in a nutshell, the mentoring program may include 1. preparing a coaching framework and a partnership between the coach and manager, 2. rotations across several specialty groups within the mw department, 3. hands-on activities and shadowing experiences, 4. lecture-type training sessions, and 5. on-the-job training with careful coaching. the training program helps novice regulatory writers gain document-specific knowledge, general mw skills, a strong regulatory foundation using industry-standard resources such as amwa and dia guidance, statistical understanding, data interpretation ability, and leadership skills. kavita garg is director-medical writing at saliegral global pvt ltd. and is based in singapore. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: kavita.garg@saliegral.com resources 1. clemow db, wagner b, marshallsay c, et al. medical writing competency model – section 1: functions, tasks, and activities. ther innov regul sci. 2018;52(1):70-77. 2. clemow db, wagner b. marshallsay c, et al. medical writing competency model – section 2: knowledge, skills, abilities, and behaviors. ther innov regul sci. 2018;52(1):78-88. 3. yih l, alexander l. amwa recommended training outline for regulatory writers. american medical writers association; 2020. accessed october 2021, https://info.amwa.org/hubfs/offers/ regulatory-writer-training%20ebook/regulatory-writer-training.pdf. table 2. case study of rotational program for entry-level mws (<1-year experience) month 1 general orientation months 2-4 rotation with assigned document* team hands-on training, writing style, clinical trial data months 5-7 rotation with clinical technical editing team quality control review; clinical study report trainings and shadowing experiences also begin months 8-9 (6 weeks) rotation with clinical content standards team technical aptitude months 9-10 (3 weeks) rotation with the document* team health literacy concepts month 11+ end rotations; begin supporting mw team on regulatory documents hands-on training *the first rotation is with the narrative team—narratives are the brief, participant-level documents that they learn at the beginning of the training program. the next rotation is with the teams writing informed consent documents. shadowing opportunities for more complex documents, such as clinical study reports, are also provided throughout the rotational program. overall, the training program includes core knowledge, soft skills, networking, and corporate culture. figure. overview of training programs for early-career mws (1-2 years’ experience). amwa, american medical writers association; mw, medical writer. http://www.amwajournal.org https://info.amwa.org/hubfs/offers/regulatory-writer-training%20ebook/regulatory-writer-training.pdf https://info.amwa.org/hubfs/offers/regulatory-writer-training%20ebook/regulatory-writer-training.pdf a m w a news katrina r. burton, bs / 2021–2022 amwa president when i was first approached by kathy spiegel to serve on the american medical writers association (amwa) board of directors (bod) and chair the inaugural chapter advisory council, i had no idea that my path would one day lead me to serving as amwa president. i am deeply humbled to accept the gavel that once graced the hands of such an esteemed succession of amwa leaders. through the years, i’ve had an opportunity to witness my predecessors successfully lead amwa through bylaws and governance changes; timely joint statements and responses to critical issues; legislation impacting medical communicators; organizational priorities; social justice awareness; and of course—a pandemic that changed the way we live, work, learn, and connect. one thing i know for sure is that amwa leaders are openminded, resilient, and constantly evolving. it is with this knowledge that i confidently step into this role. with that said, i know that i am not alone. i have the support of the executive committee, bod, committee chairs, work groups, councils, a plethora of volunteers, and an amazing and dedicated amwa staff focused on amwa priorities. as i look back on where it started, i realize i’ve had to keep evolving to appreciate where it’s going. the “it” is my career in medical communication that started at texas a&m university many years ago. it was in college station, texas, where i realized my passion for writing was just as deep as my interest in medicine, science, and health. it came as no surprise to those who knew me when i switched my major from pre-medicine to journalism. fast forward 14 years later, and i strategically aligned my career to have the best of both worlds. once i settled on what i loved to do most—sharing impactful patient stories, writing about research, clinical trials, and patient support programs—i knew i needed to enhance my skill set. i searched online for the top medical communication organization to heighten my medical writing and editing skills. lucky for me, i found amwa! the amwa southwest chapter welcomed me with open arms and wasted no time putting me to work. i’ve heard from other leaders that serving at the chapter level enhanced their experience with amwa. i, like many others, credit amwa for helping me evolve as a medical communicator and for providing me with the necessary tools and resources. merriam-webster dictionary defines “evolve” as “changing or developing slowly often into a better, more complex, or more advanced state.” what does that have to do with medical communication? let me explain. history has shown us that everything changes; and i believe how we’ve evolved as a society through science, technology, and research has also had an impact on how we’ve evolved as medical communicators. today, medical communicators are needed more than ever to communicate the science: clinical trial results, drug discoveries, and medical anomalies that can help everyone have a better quality of life. the upward path of amwa over the past couple of years, we’ve had an opportunity to experience amwa’s revamping of its educational content, development of new targeted resources and tools, and the launch of a variety of online learning programs. as we move into the new year, there is still more to come. the education committee and amwa staff are working hard to enhance and grow the amwa certificate program, deliver relevant online programming, and develop education activities to support amwa members. when we think about the relevance of our role in the medical communication space, we must also keep the value of what we do top of mind as we educate others. that’s why i am so proud of the work that is being done by amwa’s value of medical writing working group. established out of the important and ongoing work of amwa’s medical writing executives advisory council, this work group is working toward defining and quantifying the value of medical writing. i am looking forward to seeing this group bear fruit for the organization. as we buckle up for where we are going, we must also appreciate where we’ve been and celebrate the many successes that have led us here. one of the many benefits i’ve enjoyed as a member is the amwa journal. it’s an excellent peer-reviewed publication that we’ve seen transform over the years. in january from the president / inaugural address the evolving face of medical communication 186 amwa journal / v36 n4 / 2021 / amwa.org a m w a news 2021, we welcomed our new editor-in-chief, michael g. baker, who has been working diligently with the amwa staff and the amwa journal editorial board to transition the journal to a digital publishing platform. with this new technology, we will have the capability to manage the journal ’s editorial workflow and deliver content online. i’m excited to see two new sections added to the journal, one of which is entitled “technology talk.” i also look forward to the implementation of a strategy to put forth themed journal issues that resonate with our members. “digital revolution” is the first of 4 themed journal issues scheduled to publish on our new digital platform in spring 2022. as we evolve and transition to new platforms that will give us a better reach, we must also be inclusive. an organization is strengthened by its diversity, and we must bring to the table different perspectives, ideas, and values to build upon our organizational growth. as you know, medical communicators come from a variety of different backgrounds, work settings, and specialties within the medical field. for example, i am a medical communicator in the public relations field focused on pediatric oncology. no matter what our differences are, as medical communicators we have one common goal—to communicate the science to all. that means being inclusive and seizing on opportunities to diversify our skills, audience, content, and membership. with that in mind, i am pleased to share that a new task force—the amwa diversity & inclusion assessment task force—was formed to identify how amwa can foster a more diverse and inclusive environment within the association. the search for task force members, and more information on how you can support this initiative, is underway. as we continue on this incredible journey as medical communicators, i will continue to keep our priorities at the forefront of everything we do. amwa’s most important asset is our members. we value our members, and the priorities we set are established to ensure continued growth and to give our members the best experience. as we embrace technology, inclusivity, and expand upon new ways to grow the organization, i hope you will engage, connect, volunteer, share, mentor, educate, and invite others to experience and evolve with amwa! reference 1. evolve. merriam-webster. updated 2021. accessed december 10, 2021. https://www.merriam-webster.com/dictionary/evolve unlock the secrets to freelance success with this 3-part on-demand video series. gain relevant and practical advice from industry pros. run your business like a pro. • essential ingredients of a successful freelance business • bad behaviors that can sabotage your business • getting the clients you deserve unlock now in amwa online learning: www.amwa.org/freelance_success amwa journal / v36 n4 / 2021 / amwa.org 187 https://www.merriam-webster.com/dictionary/evolve http://www.amwa.org/freelance_success v37 n2 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 19 abstract communicating the results of research using concise, jargon free language optimize its likelihood of being read and cited by other researchers. more than 3 decades of publishing scientific articles has convinced us that the most efficient approach to writing a scientific paper is one that starts in the middle and works outward. such an approach means that the first items to finalize and polish are the actual tables and figures that will be included in the body of the paper (including supplemental tables and figures). this entails deciding on the order of these elements that, when viewed alone, should be able to tell the story of the paper. this first step is often the most difficult, requiring the most thought. however, once achieved, it is usually a straightforward process to write the results section (that refer to these elements) followed by the methods section. after these sections are proofed and polished, a quick review of the methods, results and associated figures and tables highlight the points that need to be made in the discussion section. the last sections written should be the introduction, to set up the entire methods, results and discussion, and the abstract, to summarize it all. when this approach is combined with frequent proofreading of the article on some medium that is different from the one used to write it, experience has shown that the result will be a clear, uncluttered paper that is completed with a minimal number of drafts and that is most likely to be favorably reviewed and accepted for publication. good biomedical science requires good communication, and scientists who clearly and unambiguously communicate their observations, analyses, and conclusions in writing1 are likely to reach a bigger audience. in our experience over the last 35 years, an approach to writing a paper that is adaptable to any topic, simple, reduces the number of drafts, and consistently results in a clear paper is one that starts in the middle and works outward.2 such an approach begins with the tables and figures of both the main paper and any appendix, continues with the results, methods, and discussion, and ends with the introduction and abstract. each of these steps is described below. a: figures and tables a paper generally includes figures and tables that clearly communicate the main message of the paper. indeed, an approach to reading a scientific paper is to first read its title and abstract and conclusions sections and then flip to the figures and tables before deciding whether to read the full paper. moreover, a paper’s figures are often presented by other scientists when discussing their own work. it is for this reason that the creation of the figures and tables is an ideal place to start when writing a manuscript. this includes those that will be included in the main paper as well as in any supplement and that together will “tell the story” of the entire manuscript. as in any story, the order in which these elements are discussed needs to be carefully considered. thus, before writing the results section, it is best to decide the specific order of these elements (eg, table 1, table 2, figure 1, supplemental table 1, figure 2, supplemental figure 1, and then table 3). even if the author ultimately modifies this order, deciding on the initial order will facilitate writing the first draft of the results section. b: results section the results section typically starts with a general description of the data that are analyzed, followed by the specifics of the analyses and findings with reference to the figures and tables. brevity is a virtue for all parts of a scientific paper, and a succinct, clearly written results section that tells the story that is shown in the tables and figures in a logical and uncluttered way will communicate the findings effectively. a supplement is the ideal spot for any information that does not directly address the study hypotheses. c: methods section a clear set of figures and tables and a straightforward results section facilitates drafting of a clear and concise hertzel c. gerstein, md, msc1-3; diana sherifali, rn, phd, cde1,4; and imran satia, md, phd3,5 / 1population health research institute, mcmaster university, hamilton, on, canada; 2hamilton health sciences, hamilton, on, canada; 3department of medicine, mcmaster university, hamilton, on, canada; 4school of nursing, mcmaster university, hamilton, on, canada; 5firestone institute for respiratory health, st joseph’s healthcare, hamilton, on, canada writing your paper from the middle practical matters http://www.amwajournal.org amwajournal.org 20writing your paper from the middle methods section. although the amount of detail to include requires judgement, the guiding principle should be that it should be sufficient to describe what was done without confusing, irritating, or distracting the reader. any other details can either be omitted or included in a supplement. the methods section, together with the results, figures, and tables, represents the heart of the paper. once it has been drafted, it is worth checking whether all the salient information, but no more, has been presented transparently. as with the any piece of writing,3 we have repeatedly found that a good way to do this is to print a clean (unmarked) copy of the methods, results, tables, and figures as well as the supplement and review these sections as if they were written by someone else. although one can never truly dissociate oneself from one’s own writing, such an effort can help the writer identify confusing or distracting text that interferes with the flow of the written presentation of the information. it is also useful at this time to have a colleague read these sections before continuing, as it is not worth writing any more of the paper until these sections are polished. d: discussion the discussion section of a paper presents an opportunity to contextualize the findings, show how they support or refute the hypothesis being tested, and show how they lead to new hypotheses or research. this is also the place where writers present their conclusions, which need to be consistent with the research design, the data quality, and the analytic approach used. for example, if a research finding is hypothesis generating, it is inappropriate to present it as hypothesis testing. in our experience, striving for clarity and brevity will reduce the likelihood of overstating the implications and relevance of a particular finding that happens to be consistent with a hypothesis and excusing or rationalizing an inconsistent finding. the contents of the discussion should directly flow from the results section and should mainly focus on the findings that were observed. this can include citing other literature pertaining to these findings and suggesting possible explanations for the findings. although every set of observations has limitations, a discussion section that spends inordinate amounts of space on “explaining away” findings that do not support the investigators’ hypotheses is usually unhelpful and distracting. a simple structure for a discussion section includes (a) restating the main findings, (b) a brief discussion of literature pertaining to these findings and how these findings advance an understanding of the hypothesis, (c) a possible explanation for these findings based on biologic mechanisms or methodology, (d) the strengths and limitations, and (e) the next steps and overall conclusion. it is important to note that a detailed literature review regarding the hypothesis best belongs in a review article, as such a review generally cannot be accommodated in the space available for the discussion section. e: introduction perhaps the easiest section to write is the introduction. the introduction should state and briefly justify the hypothesis and its implications and generally foreshadow all the key points that are included in the discussion section. a short 2-paragraph introduction is ideal for many papers. as with the discussion, the introduction generally should include sufficient information to understand why the research was done. it should simply justify the reasons or motivation for doing the study, state the hypothesis in a few sentences, and provide a big picture as to what value this adds to science. f: abstract the abstract of any paper should adhere closely to text written in the rest of the paper. most biomedical journals have word limits for abstracts ranging from 250 to 300 words. generally, the most effective way to write the abstract it is to summarize each of the other sections in 1 to 2 lines. summary writing clearly is difficult and takes practice. this is as true for writing a scientific report as it is for writing a novel, play, technical document, or financial report. regardless of what is being written, having a clear underlying structure that supports the document, and a systematic approach to building that document on that structure, can facilitate the process of writing a paper, ensure that the final product communicates clearly, and increase the likelihood that it will be used to further advance biomedical knowledge. author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. author contact: gerstein@mcmaster.ca references 1. barroga e, matanguihan gj. creating logical flow when writing scientific articles. j korean med sci 2021;36(40):e275. doi:10.3346/ jkms.2021.36.e275 2. lippi g. how do i write a scientific article?—a personal perspective. ann transl med 2017;5(20):416. doi:10.21037/ atm.2017.07.43 3. gerstein hc. writing science that your colleagues can read. j diabetes complications 2014;28(1):4-5. doi:10.1016/j. jdiacomp.2013.06.009 http://www.amwajournal.org become a medical writing ninja visit us at trilogywriting.com writers@trilogywriting.com think you have what it takes to join a world-leading team of medical writers? we’d love to speak with you. mailto:writers@trilogywriting.com https://www.trilogywriting.com/ amwajournal.org 17session reports a clear as could it be. additionally, he suggested adding a plain language abstract to the study synopsis, especially when the sponsor does not plan to provide a separate plain language summary. other handy tools include developing a plain language glossary and templates. prepare for redaction and anonymization for participant information, avoid the following: • using pronouns in patient narratives; consider using “the patient” instead, • using “verbatims” with quotes by the investigator, as these may include unique circumstances that could describe a patient, or • including patient ids in images of tables. if patient ids are required, then either include tables with selectable text (instead of copied as an image) or keep table formatting consistent across all images to ease redaction. for study or sponsor staff information and other identifiers, avoid the following: • adding names of the study staff with their organizational titles; instead, use only their study role, • including contact information such as fax, phone, or email, • incorporating cvs or certificates or adding them to an appendix, • adding personal identifiers to bookmarks (such as patient ids, names, study admin), or • providing treatment allocation and group information throughout the document. other final considerations: • limit duplication that requires duplicate redactions, for example, providing a table with patient narrative information followed by text with some of the same information. • in the sample case study report case report form (crf), use a clearly fake patient id like xxxx or 0000 (not even “1234”). • aim to keep page numbering consistent between the csr and the pdf copy to help remove out-of-scope information. • because foreign language pages are out of scope, you may keep these in an appendix or remove them. these are some best practices for medical writing with a disclosure mindset. it is part of your job as a regulatory medical writer to have a basic knowledge of disclosure regulations and support trial transparency. nisreen shumayrikh is a medical writer and scientific communicator at guanine medical in vancouver, bc, canada author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: nisreen@guaninemedical.com * * * bridging the gap: transitioning into regulatory medical writing speakers amber carr, phd, medical writer, merck, rahway, nj savannah mageau, pharmd, medical writer, merck, rahway, nj shengjie xu, phd, medical writer, merck, rahway, nj by stephany panlilio, ms the role of a medical writer is everchanging and requires a range of technical knowledge and soft skills to create cohesive documents in preparation for submission to regulatory health authorities. medical writers come from a variety of different backgrounds with varying levels of experience. for those looking to enter the field, there are a number of transferable skills from previous experiences, training opportunities, and techniques to bridge knowledge gaps in preparation for transitioning into a regulatory medical writing role. this article summarizes the experiences of dr carr, dr mageau, and dr xu as they each transitioned into regulatory medical writing. skills leveraged from previous experiences in their presentation, dr carr, dr mageau, and dr xu shared their previous roles in experimental research, pharmacy practice, computational research, and teaching and medical communication and the skills they gained from each that were transferable to their role as medical writers. the skills they found most applicable to medical writing are summarized into the following 3 categories: soft skills, technical skills, and core knowledge. soft skills the soft skills of self-management and project management that dr xu gained from her time in experimental research have helped in her medical writing role. managing time, setting priorities, and working independently are critical as a medical writer, and developing these skills can increase productivity. medical writers must be able to manage multiple project timelines and have the flexibility to adjust when something unexpected arises (eg, shifting research http://www.amwajournal.org amwajournal.org 18session reports direction, delays at clinical sites, etc.). in addition to managing timelines, managing resources is important for a successful submission, as is continuously reassessing those resources as the project develops. dr mageau was able to apply the leadership skills she developed from her previous experience in pharmacy practice. in medical writing, leadership is important because writers coordinate with several functional areas to produce documents, which includes coordinating meetings and leading presentations. technical skills dr carr found that her experiences in computational research and teaching and medical communication developed her technical skills for process proficiency and scientific communication, which in turn proved to be applicable to her role in medical writing. as a medical writer, the ability to manage and organize multiple projects concurrently and keep a process-driven approach saves time and can lead to streamlining processes in the future. as medical writing becomes more dependent on technology, it is important to have medical writers who are proficient in different software and who are willing to troubleshoot or test software as needed. scientific communication is another soft skill dr carr was able to bring from her previous experience to medical writing. having a background in scientific communication taught her how to write for her audience by ensuring that the appropriate level of detail is included for the intended audience as well as modelling scientific thinking while keeping the audience engaged. lastly, being able to communicate scientific information includes using evidence to craft a coherent story and to support the conclusions, as is done when writing clinical study reports and other regulatory documents. core knowledge in her pharmacy practice experience, dr mageau was able to gain real-world experience in several therapeutic areas, which helped to develop her core knowledge of different disease states, which is especially helpful when writing clinical regulatory documents. she was also able to utilize her experience collaborating with multidisciplinary teams as well as leading discussion and presentations, as medical writers build documents with several cross-functional teams. training opportunities numerous opportunities to further develop knowledge and understanding of the drug development process, clinical research, and medical writing are available to those looking to enter the field. training courses recommended by dr carr, dr mageau, and dr xu included the introduction to the principles and practice of clinical research offered by the national institutes of health (nih), the regulatory affairs certification preparation program offered by the north carolina regulatory affairs forum, and making medicines: the process of drug development certificate program offered by eli lilly. in addition to training courses, dr xu had the opportunity to serve on an institutional review board (irb) where she gained hands-on experience. when serving on the irb, dr xu learned local and international regulations, including good clinical practice, as well as ethical principles for clinical research. this experience also gave her the opportunity to review clinical study protocols and investigator’s brochures (ibs), which is applicable to her role as a medical writer. dr mageau participated in an internship at glaxosmithkline, where she gained experience in the global medical sciences and clinical pharmacology groups. from this experience, she compiled data and used source documents, such as clinical study reports and ibs, to write manuscripts, abstracts, and presentations. another opportunity to expand knowledge and gain experience in the industry is by networking, as suggested by dr carr. joining local and national chapters of organizations like amwa provides opportunities for communicating and creating relationships with others in the field and learning from their experiences, finding training recommendations, and attending conferences to learn what is new in the industry. bridging knowledge gaps all 3 presenters shared their experiences bridging the gaps in their knowledge in their training course at merck, which follows the amwa recommended training outline and focuses on 3 key areas: core knowledge and skills, documents, and soft skills. core knowledge and skills dr mageau recommended the amwa essential skills certificate program, which provides a background for the core knowledge in medical communication. in addition, taking this course also shows a commitment to developing professionally, further enhancing credibility as a medical writer. development of technical aptitude as a medical writer is important to enhance productivity and efficiency in writing documents. as regulatory documents are now primarily digital, microsoft word is a helpful authoring tool. in http://www.amwajournal.org amwajournal.org 19session reports addition, utilizing a collaborative authoring platform, such as sharepoint, enables multiple writers to work on a document concurrently. as documents are further developed, tools such as table, listing, and figure tools are available to help format and present data clearly to reviewers. lastly, as a large amount of data are presented in regulatory documents, it is essential to have a quality control tool in place to ensure a document is ready for submission. documents in the rotational training program at merck, drs carr, mageau, and xu were able to gain hands-on experience and participate in shadowing opportunities to develop an understanding of the types of documents that medical writers author. during that time, they learned how documents were built during the authoring process, shadowed the quality control group, attended consensus meetings, and eventually transitioned to being lead authors. soft skills lastly, further developing self-management and people skills helps to strengthen a medical writer’s ability to work collaboratively even while remote, build connections, and maintain high productivity. medical writers are responsible for leading meetings and managing a team to build a cohesive document. having strong people skills is critical to achieving this goal. when transitioning into a regulatory medical writing role, there are several transferrable skills that can be utilized from previous experiences, including soft skills, technical skills, and core knowledge. to further prepare new writers, numerous training opportunities are offered through organizations such as nih, local regulatory affairs forums, and more. lastly, amwa provides a recommended training outline focusing on core knowledge and skills, documents, and soft skills that further helps to bridge any knowledge gaps for new writers entering the everchanging field. stephany panlilio is a senior associate in medical writing at gilead sciences, inc. (foster city, ca) author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. author contact: stephany.panlilio@gilead.com * * * growing your career as an editor speakers crystal herron, phd, els, redwood ink, san francisco bay area, ca loretta bohn, els, rti international, research triangle park, nc erica goodoff, els(d), the university of texas md anderson cancer center, houston, tx by angela trenkle, bs being a strong editor is a skill set that can open many doors in the medical writing field. in this panel session, three editors discussed some of their tips and tricks for navigating the world of editors. how editing and writing differ ms goodoff began by explaining that writing is almost like a brain dump; you are just writing everything that is in your mind with regard to the topic. editing requires more of a critical thinking piece: i have content, but how do i shape it? dr herron added that emotional intelligence is also an important skill to have for editing so that you can eloquently explain your proposed changes to authors. ms bohn also emphasized that editing is not personal and that editors are looking at the writing from a different perspective—advocating for readers. all three of these editors mentioned that it was important to explain why you’re recommending the changes and to back up your suggestions with data and resources. key skills for editing grant proposals ms goodoff began by stating that a key skill for editing grant proposals is to find ways to make it as effortless as possible to read the text and to make sure that the logic flows and ties back to the main objective. dr herron emphasized that the storytelling element of the research project is important, which includes how the research project is expected to end. ms bohn pointed out the navigation pane in word, which is a good way to look at pieces of a grant for consistency. all three mentioned the importance of cutting down the length and wording and ensuring that the entire document is consistent in flow. teaching/mentoring editors ms goodoff began by discussing how coaching new colleagues in editing differs from editing when the client is the only one who will see your edits. it can be helpful to teach new editors because it helps you to become a better editor, but you must find that balance between fixing the problems and teaching the new editor to do it themselves. with http://www.amwajournal.org v37 n1 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 50 q1: in the new digital age, what are some of the changes you have been making as a medical writer? one of the keys to freelancing success is adaptability, and nowhere is that more important than in the area of technology. my goals are to optimize my productivity and to stay at least 1 step ahead of my clients. these are a few of my most recent advancements to keep up with or ahead of the curve: • online software: i get about 5 years out of a computer. when it’s time for a new one, i have to upgrade most of my software as well. getting used to new hardware and software at the same time is a nightmare! in 2019 i subscribed to office 365, and last year i upgraded to microsoft 365. i also switched to the online version of my bookkeeping software, quickbooks. online software upgrades continuously so the changes are incremental instead of sweeping. it also ensures i’m always working with the latest versions. • cloud backup: about 3 years ago, i switched from a local backup for my computer files to a cloud backup system. i did my research, consulted with my computer guru, and went with carbonite. it offers 128bit encryption, world-class security, and health insurance portability and accountability act compliance support. it saved my life! during the summer, my computer system had a bit of a hiccup and i lost everything. within 24 hours, i had it all back. • password manager: i’m overwhelmed with passwords. recently i began researching password managers and questioning why i’ve been so hesitant to use one. the answer is fear of the unknown. now that i have a better understanding of their security and potential benefits, i’m getting closer to switching over from my current archaic method. • multiple monitors: i’ve always docked my laptop to an external monitor. about 7 years ago i added a second external monitor and immediately wondered why i waited so long! today i use 3 external monitors and could easily justify more. not only has it made me more efficient, but it has also saved me a ton of money on printer supplies. — brian bass naturally, we all try new programs to keep up—but i try to avoid spending money unless something is truly essential for me (eg, microsoft word). having worked with many new small programs that i found unhelpful and too glitchy (eg, endnote, grammarly), i stopped using them. i use the spellcheck and grammar check in the word program. because i have been a medical writer for more than 25 years now, i trust my english usage without adding yet another electronic helper. of course, newer people with little hands-on writing experience who are trying to enter the field of medical writing likely need the grammar check programs more than those with years of experience. i do feel that new graduates, or those switching from other professions to medical writing, should practice writing on their own so they are more skilled at writing better and faster—this skill comes solely from practice, not from reading about it. but almost everything can be obtained online now. because of the annoying (to me) practice of having to subscribe to programs on a monthly basis rather than purchasing them outright and owning the program, i have stopped using certain programs—eg, quarkxpress, adobe illustrator, adobe indesign, and adobe photoshop. this means that i also have stopped taking on projects that require these programs; i do not regret it, although i was once reasonably proficient with quark and illustrator. to me, the editing function in adobe acrobat is far more cumbersome and less efficient than editing in word, so i also no longer take on projects that require heavy editing in that program. i prefer now to focus on medical writing, editing, freelance focus brian bass melissa l. bogen gail v. flores ruwaida vakil http://www.amwajournal.org amwajournal.org 51freelance focus editorial review and critique, format correction, template creation, and quality assurance for regulatory documents. today, almost everything is now done via the internet and social media, and we all have gradually adjusted to this. no longer is it so easy to call a client or consultant on the telephone; now it is either email or text messaging. nonetheless, i always speak to a new client by phone before accepting a new project; it is simply more efficient. today most pharmaceutical/contact research organization clients use shareware programs such as dropbox or googledocs rather than attaching the files to an email; this change has been required for several years now. because of poor project management on the part of too many clients, this process is frequently more cumbersome than receiving the required materials via email, but one has to ride the horse in the direction he’s going so i accept this. once in a while (not often), i encounter a good project manager, and materials are well organized, clearly labeled, and easy to grab. one can obtain templates and samples of most regulatory reports in the international council for harmonisation of technical requirements for pharmaceuticals for human use format online as necessary—but i have all that already from having written so many throughout my career. likewise, today it is easy to download sample articles from a specific journal (in addition to the instructions for authors) to ensure using the proper formats and editorial styles. on the whole, over the last many years, clients expect medical writers to have a strong facility with technology; often they care more about the tech aspects than the actual writing and the skill of good communication. equally often, they do not seem to recognize the difference between clear communication/decent writing and the kind of rote things that less experienced people produce. so, i think the horse will continue galloping in this direction and all of us must adapt. if there is too much technology involved and too much unclear data provided, one may opt not to accept that particular project. — cathryn d. evans in the last 1-2 years, i’ve made changes enabling me to become increasingly less reliant on paper. to proofread my own work, i now save my word or powerpoint documents as portable document format files (pdf), which differentiates them enough that i spot errors i wouldn’t have noticed in the native files. i review the pdfs on one monitor and enter edits directly into the native files on my other monitor instead of printing the document, proofreading with a red pen, and entering edits into the native files. not only am i saving paper, but i’m also saving time. to reduce my use of notepads and sticky notes, i’ve started using onenote (part of the microsoft office suite). i have various notebooks for meeting notes, invoices, and to-do lists, with tabs for different clients. i particularly like being able to take meeting notes in calendar invites imported from outlook, so i can capture the date/time of the meeting and the attendees. i recently started using the scheduling feature of the online time-tracking platform i’ve been using for years (paymo). i can see my entire week and month at a glance, including the due dates for each deliverable for each project. it had made scheduling so much easier that i no longer need a physical planner. overarching these individual changes is my move to 100% cloud storage. i’m a mac and iphone user, and everything on my computer is backed up to my icloud account. i didn’t realize how useful this was until one day last year when my mac completely died, late in the afternoon, when my first deliverable was due to a new client. i was able to log on to my icloud account from another computer in the house and was up and running in the same word file and could access the same highlighted references, bookmarked websites, and emails within 20 minutes. as medical communicators, i believe we should continue to learn about new programs, platforms, and technologies to increase our value to clients. for those of us who don’t have tech support, so many issues can be solved through a simple google search or youtube video, empowering us to approach our clients with solutions rather than problems. — gail v. flores the primary change is that i now have a cloud backup system in place. in june, i bought a new computer. i thought my external 1-tb backup drive with nightly backups would work seamlessly to transfer all my data to the new computer in case the geek squad had trouble with the computer’s hard drive. the day i gave my computer to the geek squad the external backup drive said it was full. because of the proprietary backup software, the files could not be dragged and dropped off the drive, and i had trouble clearing space. nevertheless, i thought i had managed to do a full backup that day. my computer’s hard drive had been working fine, but the geek squad said the hard drive failed during the data transfer, so they used the external backup drive to transfer data. unfortunately, something must have gone awry with the backup and many of my word files were missing. http://www.amwajournal.org amwajournal.org 52freelance focus another american medical writers association (amwa) colleague suggested using a cloud back-up system. many such systems are available. i chose carbonite safe basic (https://www.carbonite.com/). usually $84/year but now on sale at about $60/year, the service includes automatic unlimited backup and remote access from any device. the files can be accessed individually by drag and drop or restored as a group. now i no longer worry about my backup. another bonus: i can access my complete hard drive remotely, so i don’t have to copy files to dropbox to transfer them to my laptop. — melissa l. bogen * * * q2: what software do you recommend to a new freelancer? microsoft office is of course a must for any new freelancer for creating and working in word, powerpoint, and excel documents; other features such as outlook and onenote are optional, but i prefer using them as they work well with my other office products (for example, my customized spellcheck and autocorrect settings are automatically incorporated across all products in the microsoft suite). adobe acrobat pro dc is critical for highlighting and annotating journal articles and other references. finally, an accounting program is key for submitting and tracking invoices. in addition to software housed on a computer, i recommend that new freelancers subscribe to an online time-tracking platform, a medical dictionary, and a cloud storage system, such as dropbox. i resisted investing in such tools for years because i didn’t want to spend additional funds, but once i got them i couldn’t believe i ever functioned without them, as they have both increased my efficiency and let clients know that i take my work seriously and have more than paid for themselves over the years. — gail v. flores go to https://www.amwa.org/page/partner_discounts to find discounts for amwa members on some of these software programs: • ama manual of style (20% off for amwa members): i bought the hardcover edition with one year of the online subscription so i can look things up quickly while i’m working. the online version has automatic updates. however, the online version is not as clearly set up as the hardcopy, so i often consult my hard copy once i know where to look. https://www.amamanualofstyle.com • stedman’s plus 2022 medical/pharmaceutical spellchecker: this software works seamlessly in microsoft office programs (word, powerpoint, etc) and contains all the latest medical and pharmaceutical terms. usd $99.95. https://shop.lww.com/stedman-s-plus-2022medical-pharmaceutical-spellchecker--single-userdownload-/p/9781975183677 • perfectit (30% off for amwa members): proofreading software for professionals. you can start a free trial for 14 days. https://intelligentediting.com • jack lyon’s editor’s toolkit plus and list fixer, among others. you can strip footnotes to the end of a file, change automatically numbered lists to fixed numbers, and automate many repetitive tasks to free up your brain for the more substantive edits. https://www.editorium.com — melissa l. bogen * * * q3: what are the pros/cons of using grammar or proofreading software such as grammarly or perfectit? i have only used perfectit, which has been essential for my work as a medical editor. perfectit automatically runs some standard consistency checks (eg, compound adjectives before a noun, hyphen or no hyphen, common typos). when an inconsistency is found, it shows the 2 variations and the user chooses the preferred form. the program will stop at each instance to let you decide how and whether to fix the inconsistency. perfectit cannot replace an editor. it handles mechanical aspects of job, leaving the editor to make substantive edits. the table of abbreviations that perfectit creates at the end is worth the price of the program. the table that is created must be double-checked because, for example, abbreviations in square brackets are not found and it “thinks” author initials are abbreviations, but the table easily compiles the vast majority of the abbreviations in a file that can be saved as a separate document. versions • perfectit 5 (standalone) is the latest version • perfectit cloud (is mac compatible) – secure connection does not send data anywhere – files are confidential http://www.amwajournal.org https://www.carbonite.com/ https://www.amwa.org/page/partner_discounts https://www.amamanualofstyle.com https://shop.lww.com/stedman-s-plus-2022-medical-pharmaceutical-spellchecker--single-user-download-/p/9781975183677 https://shop.lww.com/stedman-s-plus-2022-medical-pharmaceutical-spellchecker--single-user-download-/p/9781975183677 https://shop.lww.com/stedman-s-plus-2022-medical-pharmaceutical-spellchecker--single-user-download-/p/9781975183677 https://shop.lww.com/stedman-s-plus-2021-medical-pharmaceutical-spellchecker/p/9781975164324 https://intelligentediting.com/ https://www.editorium.com amwajournal.org 53freelance focus tutorial: https://intelligentediting.com/product/ introduction/ tips for editing in perfectit: https://intelligentediting.com/ support/faqs/categories/tips-for-editing-with-perfectit/ — melissa l. bogen as a writer, i have not invested perfectit primarily because i use a mac, and perfectit only has cloud support on macs. many of perfectit’s functions are limited while using a mac, so i have not found it worth the investment. i would consider it if they offered a mac version that is as good as the pc version. however, i have used grammarly. i found it very helpful for doing grammar and language checks that word will often miss. it is like a second set of eyes for me and is very valuable when working on the same document for too long. on mac, grammarly is also cloud-based and is not integrated with word. but it seems to have all the features that the pc word-integrated version has. therefore, i have found it to be a good investment. — ruwaida vakil unlock the secrets to freelance success with this 3-part on-demand video series. gain relevant and practical advice from industry pros. run your business like a pro. • essential ingredients of a successful freelance business • bad behaviors that can sabotage your business • getting the clients you deserve unlock now in amwa online learning: www.amwa.org/freelance_success http://www.amwajournal.org https://intelligentediting.com/product/introduction/ https://intelligentediting.com/product/introduction/ https://intelligentediting.com/support/faqs/categories/tips-for-editing-with-perfectit/ https://intelligentediting.com/support/faqs/categories/tips-for-editing-with-perfectit/ v37 n3 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 28 abstract for much of its history, the american medical writers association (amwa) has bestowed awards in honor of certain members: harold swanberg, md, the founder of the association; walter alvarez, md, in retirement, a nationally syndicated health columnist; eric martin, phd, a pharmacist instrumental in professionalizing regulatory writing; and john mcgovern, md, a philanthropist who supported initiatives in biomedical communication. however, the details of the lives of these men are unknown to most amwa members. accordingly, this biography describes the life and accomplishments of eric martin, to recognize his achievements and to contribute to the history of the profession and of the association. the eric w. martin award for excellence in medical writing was awarded by amwa from 2007 to 2015. however, we know more about those receiving the award than we do about the man in whose honor the award is given. in part, this lack of information may be attributed to eric himself. he has been described as a quiet but pleasant man who seldom talked about himself; the sort of person who would learn more about you than you would about him in casual conversation. (lilian sablack telephone call, june 27, 2020.) we know little about his personal life and not much more about his professional life, but there is something to tell. personal life eric wentworth martin, phc (pharmaceutical chemist), bsc (bachelor’s degree in pharmaceutical chemistry), ms, phd, was born on december 6, 1912, in kamloops, british columbia, canada, to wentworth banger martin (18881945) and ida magdalen (1886-1984).1 he graduated from high school in 1928, eventually entered an apprenticeship in pharmacy, and became a qualified pharmacy assistant in 1934. at some point, he became a registered pharmacist in both the united states and canada.1 we know even less about his wife, ruth d. martin, dsc, who collaborated with him on several publications. according to lilian sablack, amwa’s executive director from 1973 to 2001, who knew eric for some time, he rarely talked about himself. her recollection of him was that he had no children and that ruth may have been his second wife. professional life much of the information on eric’s professional life comes from the “about-the-author” sections of his many publications. at some point in his career, he was director of communications for lederle laboratories in new pearl, new york, and for several years, he was also associate professor of medical communication at columbia university college of pharmacy.2 between 1949 and 1952, he was an associate director of lawall and harrison research laboratories (now sgs harrison research laboratories), a company that still provides consumer product testing services.3 during this same period, he was assistant professor of biochemistry at philadelphia college of pharmacy. (the college eventually changed its name to the university of the sciences. it offered the only master’s degree program in medical writing in the country4 until it was absorbed by st. john’s university earlier this year.) from 1956 to 1959, he was editor-in-chief of the journal of the american pharmacists association, practical pharmacy edition,5,6 executive director of spectrum at pfizer, may have been professor of physical pharmacy at purdue university, and later became director of professional communications at the food and drug administration. he was a fellow of the american association for the advancement of science and of the international academy of law and science. he was also a fellow of amwa, the first president of the association who was not a medical doctor, and the author of amwa’s first code of ethics, in 1978.2 tom lang / principal, tom lang communications and training international, kirkland, wa eric wentworth martin – pharmacist, researcher, author biography figure 1. eric wentworth martin, phc, bsc, ms, phd (1912-?) http://www.amwajournal.org amwajournal.org 29eric wentworth martin – pharmacist, researcher, author but there’s more... from 1942 until 1953, eric served in the us army medical corps and chemical warfare service, which was part of the office of strategic services (the oss; forerunner of the central intelligence agency). at the end of this period, he became a senior research biochemist at the institute for cooperative research at the university of pennsylvania.7 the institute conducted secret research into chemical and biological warfare until its activities came to light during the vietnam war in 1965.8 the institute was closed in 1968.9 (a note for balance: during world war 2, george w. merck, president of merck & company pharmaceuticals from 1925 to 1950, led the war research service that was in charge of the us biological weapons program. merck was awarded the medal for merit for his contribution to the war effort.10) professional activities almost all references to eric are from books he wrote or edited. they all appear to be major texts that went through several editions. • husa's pharmaceutical dispensing. martin ew, ed. mack; 1959. he edited the first 7 editions of this book. • remington's pharmaceutical science. martin ew, ed. 13th ed. mack; 1965. in 100 chapters (1,616 pages) by separate authors, the book covers the scientific, professional, and economic aspects of pharmacy. • martin, ew. techniques of medication: a manual on the administration of drug products. alexander sf, hassan, we jr, sherman bs, eds. 1st ed. j. b. lippincott; 1969. eric’s wife, ruth d. martin, was an associated editor of this book. • martin, ew. hazards of medication: a manual on drug interactions, incompatibilities, contraindications, interactions, and adverse events. j. b. lippincott; 1978. the book cites 3,000 references and contains a 400page table of drug interactions for more than 600 of the most widely used drugs. (the number of drugs increased to 1,000 in later editions.) another 50-page table details how many drugs interfere with the results of laboratory tests. • martin ew. drug interactions index 1978/79. lippincott; 1978. the drug that changed everything thalidomide was an over-the-counter sedative widely used in europe to treat anxiety, sleeplessness, and morning sickness during pregnancy. in the late 1950s, it was linked to fetal deaths and serious birth defects (the phrase does not capture the horrific effects of the drug) in thousands of newborns. at the time, drugs were tested only on rodents and did not have to be tested for teratogenic effects. the drug was never marketed in the united states because its approval was blocked by a young us food and drug administration (fda) inspector. frances kelsey, md, phd—on her first assignment during her first month at the fda— based her decision on the fact that the data in the application for thalidomide did not establish its safety and effectiveness and that there were no data indicating whether the drug could cross the placenta.11 despite pressure from the manufacturer and from others inside the fda, she prevailed in preventing the drug from being approved.12 dr kelsey also noted that there were no data from clinical trials of the drug in the united states and that there was no way of knowing whether such data would be reliable. clinical trials were not yet required for fda approval, and any trials that were conducted were not subject to oversight. “[t]he ‘clinical trials’ of thalidomide in europe involved distributing more than 2.5 million tablets of the drug to about 20,000 patients, including 3,760 women of childbearing age, of whom at least 200 were pregnant. more than 1,000 physicians participated in these trials, but few tracked their patients after dispensing the drug.”13 (unknown to the fda, thalidomide had already been distributed to 1,200 physicians in the united states, many of whom were treating pregnant women. the agency eventually launched a nationwide campaign to recover as much of the drug as possible.14) the thalidomide tragedy led to the 1962 kefauver-harris drug amendments to the federal food, drug, and cosmetic act that required manufacturers to prove both safety and efficacy and greatly increased surveillance and monitoring of the drug approval process.14 the new regulations also required manufacturers to disclose all side effects encountered in testing and to provide the public with accurate figure 2. the hazards of medication, by eric w. martin, phd. this 900page volume contains a 400-page table of drug interactions and includes information on more than 600 of the most widely used drugs. another 50-page table details the ways in which many drugs can affect the results of laboratory tests. the first edition sold 30,000 copies. http://www.amwajournal.org amwajournal.org 30eric wentworth martin – pharmacist, researcher, author information about the side effects and efficacy of a drug. the fda also launched the drug efficacy study implementation, an initiative that retrospectively evaluated drugs already on the market by 1962. this tightening of regulations was global; the european union adopted directive 65/65/eec1 in 1965 to coordinate the approval process in the european economic community, and the united kingdom passed the 1968 medicines act to control the testing and manufacture of drugs for human and veterinary use.14 for her part in saving the united states from the same disaster europe had experienced, president kennedy awarded dr kelsey the president's award for distinguished federal civilian service, the highest honor given to a civilian in the united states. she was the second woman to receive the award.11 these changes in the drug approval process and the need to meet new and extensive domestic and international licensing requirements created great uncertainty among manufacturers. to address this uncertainty, 30 pharmaceutical professionals, medical writers, and academics founded the drug information association (dia) in 1964.15 the idea behind the association was that “a climate of cooperation expedites the transfer of drug information from the minds of those who have it to the minds of those who need it, with a minimum of duplication of effort,” according to one of the founders and its first president, dr eric w. martin (box).2,15 today, the dia has more than 22,000 members from 80 countries. based in washington, dc, the association has regional offices in pennsylvania, china, japan, switzerland, and india. it publishes the quarterly, peer-reviewed drug information journal, and sponsors more than 125 meetings, trainings, and continuing education courses each year.15 closing the eric w. martin award for excellence in medical writing was bestowed on amwa members who in the previous year published print or electronic monographs or articles on topics either for the public or for a professional medical audience.16 the award may have been established by eric’s wife, ruth, in honor of his life (telephone call with lilian sablack june 27, 2020). much of eric’s life is unknown. he is not mentioned on the dia website, and his name does not appear on internet searches, other than as an author or on the award named for him. so, it is not surprising—and perhaps even fitting—that i still could not determine the date of his death at the time of this writing. author declaration and disclosures: the author reports no competing interests with this article. author contact: tomlangcom@aol.com references 1. kramer je. third decennial supplement to the “first century of the philadelphia college of pharmacy.” 1941-51. philadelphia college of pharmacy and science; 1952. the rebirth of amwa as horrible as thalidomide was, it also saved amwa. from its founding in 1948 and throughout the 1960s, the association was an organization of physician journal editors. as the physician members retired and were not replaced, membership became dangerously low. eric became president in 1970, when the need for more complete and standardized regulatory documents increased the demand for regulatory writers, which of course was eric’s area of expertise. he and four others created much of the association as we know it today: arnold melnick, do, executive vice chancellor and provost of the health professions division, nova southeastern university, who, in retirement with a friend, decided to start an osteopathic school in 1980 and enrolled the first class in 1981. red schifrin, phd, a clinical researcher at hoffmanlaroche who became vice president and head of drug regulatory affairs and was widely regarded as an expert in drug approval. his prestige was instrumental in attracting new members and sponsors. bill nelligan, the executive director of the american college of cardiology, who (surreptitiously) donated space, clerical support, and the salary for an executive director for 2 years. he remained a loyal supporter of amwa throughout his career. lillian sablack, amwa’s first executive director, was hired in 1973. she helped establish the annual meetings and brought order to the administrative functions. (lil was my sister-in-law for many years, and we are still close. she loved to repeat a joke i once told her “what’s the difference between lil and a terrorist? you can negotiate with a terrorist.” it’s funny because it’s true . . .) these 4 people reorganized amwa, began what was called the core curriculum, established a conference built around workshops of the core curriculum, and began to appeal to new constituencies. regulatory writers began to join, as did writers and editors in scientific publications. later, employees of medical communication companies and contract research organizations, both of which serve the pharmaceutical industry, also began to join. the rest, as they say, is history. (telephone conversation with lilian sablack, july 2020.) http://www.amwajournal.org amwajournal.org 31eric wentworth martin – pharmacist, researcher, author 2. melnick a. melnick on writing: an anthology of columns from the american medical writers association journal. authorhouse; 2012. 3. sgs acquires harrison research laboratories. sgs website. published june 19, 2017. accessed july 4, 2020. https://www. sgs.com/en/news/2017/06/sgs-acquires-harrison-researchlaboratories-inc-usa 4. university of the sciences program in biomedical writing. accessed july 1, 2022. https://www.petersons.com/graduateschools/university-of-the-sciences-in-philadelphia-college-ofgraduate-studies-program-in-biomedical-writing-000_10039831. aspx. accessed july 1, 2022. [au: the university of the sciences was absorbed by st. joseph’s university june 1, 2022, 1 month before this article went to press. the university of sciences master's program in medical writing was discontinued after the merger. there are no details. the link here is to a company specializing in preparing students for standardized testing that also has a directory of university programs. 5. fischelis rp. dr. martin becomes editor. j am pharm assoc pract pharm ed. 1956;17:219. 6. martin ew. a new vocabulary: adverse drug experiences and edp. j am pharma assn. 1966;ns6(2):69-72. accessed july 1, 2022. https://www.japha.org/article/s0003-0465(15)31375-6.pdf 7. martin ew. hazards of medication: a manual on drug interactions, incompatibilities, contraindications, interactions, and adverse events. j.b. lippincott; 1971. 8. herman es. university of pennsylvania’s cb warfare controversy. bioscience. 1967;17(8):526–529. 9. langer e. university of pennsylvania: it’s hard to kick the habit. science. 1967;155(3759):177. 10. george merck: american chemist. peoplepill website. accessed july 4, 2020. https://peoplepill.com/people/george-w-merck/ 11. national library of medicine. changing the face of medicine. dr. frances kathleen oldham kelsey, celebrating america’s women physicians. national library of medicine website. accessed july 6, 2020. https://cfmedicine.nlm.nih.gov/ physicians/biography_182.html 12. fintel b, samaras a, carias e. the thalidomide tragedy: lessons for drug safety and regulation. accessed july 1, 2022. https:// vaccinesafety.info/2021/08/26/the-thalidomide-tragedy-lessonsfor-drug-safety-and-regulation-helix-magazine/ 13. stephens t, brynner r. dark remedy: the impact of thalidomide and its revival as a vital medicine. basic books; 2009. 14. us food and drug administration. kefauver-harris amendments revolutionized drug development. accessed july 1, 2022. https://www.gvsu.edu/cms4/asset/f51281f0-00af-e25a5bf632e8d4a243c7/kefauver-harris_amendments.fda. thalidomide.pdf 15. reilly mj. drug information: literature review of needs, resources, and services. u.s. health services and mental health administration; 1972. 16. american medical writers association. membership recognition & award. amwa website. accessed july 1, 2022. https://www. amwa.org/page/past_awards www.amwa.org/mwc three little letters. one big deal. apply now apply by october 17 for december 2022 exam. review our applicant handbook, candidate guide, and study tips to help you prepare. http://www.amwajournal.org https://www.sgs.com/en/news/2017/06/sgs-acquires-harrison-research-laboratories-inc-usa https://www.japha.org/article/s0003-0465(15)31375-6/pdf http://www.amwa.org/mwc https://www.amwa.org/page/past_awards amwa journal / v36 n1 / 2021 / amwa.org 11 lisa sanders, md / associate professor, yale school of medicine, new haven, ct; clinician educator, yale internal medicine primary care residency, new haven, ct; yale new haven hospital, st. raphael’s campus, new haven, ct; contributing writer, new york times magazine, new york, ny learning curves the john p. mcgovern award is named in honor of john p. mcgovern and is presented to a member or nonmember of amwa to recognize a preeminent contribution to any of the various modes of medical communication. the mcgovern award is presented during amwa's medical writing & communication conference. john p. mcgovern award address awards conference coverage2020 amwa medical writing & communication conference dates: tbd location: online trends and opportunities for medical communicators thank you so much for inviting me to this, the new normal, the virtual conference. it’s an incredible honor to be asked to come here, to be given this mcgovern prize, and it’s made even more meaningful by the fact that it comes from my peers, the people who really know how it’s done. but to be honest, what i do in my column doesn’t seem to me so very different from what i do every day in the exam room. i take the complex story of people’s bodies and people’s diseases and give it back to them, explain it to them, in the words and ideas that i think and hope they’ll understand. i think john mcgovern understood this. he was a real giant in medicine and fully embodied that connection between medicine and the humanities. in reviewing the past winners of this award, i see some of my favorite doctors on the planet, doctors who were also writers. it means so much to be included in this extraordinary crowd. i wanted to take a few minutes to talk a little bit about my own learning curve and how i learned to write. real learning is never a pretty process. for this talk, i’ve dolled it up as much as i can, but it remains a swath cut through a field of failure. but as i tell the doctors i train in both medicine and in writing, there’s nothing like failure to help you learn something really, really well. writing is no different. it is success carved out of failure. in putting these remarks together, i marked my route to learning the writing craft with comments that were made to me by friends or colleagues that showed me the way. these were often off-hand remarks that somehow, for some reason, resonated with me. you hear exactly the right thing at exactly the right moment and, “click,” it all makes sense. sometimes it can take a long time to understand exactly why. of course, we all have many of these kinds of aphorisms or little lines that we tell ourselves, but i’ve picked just a few to help me show you what i needed to do, what i needed to hear, in order to learn to tell my stories. like many of you, i was an english major in college. but real communication, especially communicating with people you don’t know, that’s different. and i had to learn it on the job. and for me, that job was at abc’s good morning america. like most of the women at abc, i started as a secretary and slowly worked my way up to researcher and finally to producer. my very first assignment as a producer was to create pieces with the new guy, john stossel. this was before he took that big right turn and left abc news to go to fox. this was back when he was a consumer reporter. he had a job on 20/20. he also had a slot on good morning america. our first story was about airbags. we travelled to washington to go to the department of transportation to do a story about this new device. that’s how long ago this was. the big fear at the time was that these airbags would go off while you were driving. so, we did a demonstration of signposting: my learning curves 1. you know what it looks like. 2. where are my stories? 3. you can see it in his eyes. 4. watercooler stories. 5. once more with feeling! john stossel © g ag e sk id m o re c c b ysa 3 .0 12 amwa journal / v36 n1 / 2021 / amwa.org that. we did interviews. john did his standup. and then, at the end of the shoot, john gave me the tapes and told me to go put it together. i’m like, i don’t know how to do that. i’ve never done that before. he looked at me like i was some kind of moron. he said, “you’ve watched tv all of your life, you know how it looks, you know how it sounds.” and he sent me on my way. it turned out, much to my amazement, he was right. it took me and an editor so many more hours than it should have, but we finally put together a story that looked very much like stories that you see on television. i couldn’t believe it. most of my life, i’d been taught the things i needed to know. suddenly john was telling me i had to figure them out. and it was terrifying, but it was also incredibly liberating. to know that, whatever it is i needed to know, i could just go learn it. amazing. actually, it was also a little frightening to see that this same philosophy existed in medicine. it wasn’t long that i was in medicine that i heard the phrase “see one, do one, teach one.” you teach yourself; you learn by seeing it once. fortunately, we’ve moved away from all that. thank god. if john stossel taught me that i already knew what television looked like and sounded like, it was another correspondent, maria hinojosa, who introduced me to the idea that the media i made also needed to reflect who i was. i knew maria when we were both lowly producers at the cbs morning news in the late 1980s. she was young and smart and far more cosmopolitan than i was. and while i was focused on mastering the art of telling the usual kind of tv news story, maria chafed at those constraints. she wasn’t interested in mastering that kind of story. she wasn’t even interested in telling that kind of story. she had her own story she wanted to tell. she was from california. her family was from mexico, and she knew that there were stories from her world that weren’t being told. and maria thought—and time has certainly proved her right—that these stories needed to be told. “where are your stories?” she asked me then. i admired her tremendously but thought that was a crazy question. the media wasn’t there for us to use to tell our stories, it was for us to use to tell their stories. the stories of the old white guys, although i’m sure i didn’t see it that way then. these were the stories of the news. those stories. and maria was not interested in telling those stories. she left cbs after a year or so to carve her own way forward, but it was those conversations we had in the hallways of cbs news that stayed with me. finally, i wondered, where are my stories? it took me a long time, years, really, before i really found the stories i wanted to tell. it wasn’t until i left tv news and went to medical school. it was there that i found the stories i wanted to tell. i wanted to share how very cool it was to be a physician, to hear patient stories, to help them answer the question that brought them to my office: “doctor, what’s wrong with me?” but, as i found out, i still had to learn how to tell those stories. to learn that, i needed a coach. atul gawande said in an essay a couple of years ago that everyone needs a coach, and i think he’s right. or at least i needed a coach. and this was my coach: my husband, jack hitt. he’s a writer and radio personality, and he’s an extraordinary storyteller. i learned a lot about telling stories just watching him do it. seeing him figure out the beats and watching him adapt a story to fit his audience, their mood and interest. but i learned the most about telling my stories from his eyes. we started off in life together as 2 journalists. me in tv, him in print. and we would come together at the end of the day and talk about what we saw, what we did. when i went to medical school, it seemed natural to me to have the same kind of sharing. plus, what i was seeing was so powerful, so important, so amazing, that i couldn’t wait to tell him all about it, and he’s a great listener. but sometimes as i told this new kind of story, i could see he wasn’t really listening. i’d start a story and somewhere along the line, i’d see that i’d lost him. it was something in his eyes. his eyes would provide immediate feedback about what worked and what didn’t work—real-time, honest feedback. way more honest than he’d ever be verbally. i could see immediately when his attention wandered, and i could see how to tweak that story to get it back. i didn’t tell him about this for years. i didn’t want to ruin it. he still doesn’t believe me, but it’s true. and i still rely on his eyes when i have a story that i’m not sure exactly how to tell. not surprisingly, he’s who i really write for. when i teach writing, i tell my students that they need to keep their audience in mind. that they need to have a picture of who it is they’re amwa journal / v36 n1 / 2021 / amwa.org 13 writing for. i used to say that the person i had in my mind, that my audience, was an 11-year-old boy. someone who was interested, curious, but didn’t know anything. it’s only recently that i realized that the real reader i was writing for is my husband, who is really an 11-year-old boy in disguise. that’s him in the foreground and him age 11 on the left. it turns out who you write for in your head is incredibly important. it helps you find the right voice, the right words, how to pitch the right ideas. and when you write for the wrong guy, when it’s the wrong person in your head, well, all bets are off. i used to write for the wrong guy. alone at my desk, i could feel the disapproval of this old guy, this old doctor in my mind, i could feel him breathing down my back. i couldn’t help it. i wanted to please this guy. i wanted to write for the approval of the doctors who told me these stories, and the doctors i saw in the hallways and in the conference rooms of the hospital. these are the folks, the doctors, the scientists who taught me. these are the people i respect and admire. but they are not my audience. they already know this stuff. it doesn’t make any sense to write for these guys. yet it’s sometimes hard to remember. coming to med school in middle age, i had a terrible case of imposter syndrome. and because of that, i used to worry that doctors would think i didn’t understand medicine if i described it in language that anyone could understand. after 18 years of writing my column, i mostly know that even doctors appreciate clarity and simplicity. and yet, even knowing this, there are times when this old guy still haunts me. there are 2 guys who started my career at the new york times magazine. of course, neither one of them is there anymore. one is paul tough. he’s a remarkable writer. a fantastic writer—writes about education—but 20 years ago, he was a new editor at the new york times magazine and had been given the job of coming up with something new for the front of the book. i had just completed my training and taken the job on the faculty at the program where i trained at yale when paul called me and a bunch of other doctors. he asked one question: “what can doctors write?” oh, i had an immediate answer. it was a story i’d been fascinated by since halfway through med school. doctors like me, internists, we write the story every day. it’s a story about a patient who comes in with a problem and asks for help in figuring out what’s going on and how it can be fixed. it’s a mystery story. a detective story. the challenge of figuring out these mysteries is a big part of why we become doctors in the first place. so that was the story i pitched to paul. he didn’t believe me. and why should he? it was one of the best kept secrets in medicine. i went to med school after covering medicine for years. i thought i understood how medicine works. but i didn’t know this. i didn’t know that any single symptom could have any number of causes. and i didn’t know that the big challenge for doctors was figuring that out. they don’t tell you that. doctors, at least the ones i’d seen on tv, and had interviewed as a journalist, they all seemed so confident, so certain. and the science they talked about seemed so solid. i was amazed when i first saw what an uncertain practice it all was. i didn’t know this. no one knew this back then. of course, the secret is out now. it was the subtext of a show based on my column. well, my column crossed with the work of one of my earliest heroes, sherlock holmes. the show was house m.d. it’s easy to see now that the story that doctors write, called an “h&p” or “history and physical,” is structured a lot like an episode of house or vice versa. the h&p starts with the chief complaint, the lead, really. or, if it were an episode of house, it would be the cold open. something dramatic happens to the patient. then you get a little context. what happened right before the drama? this is called the history of the presenting illness. then you get a little backstory about the patient, him or herself. in medicine, it’s the past medical history and the physical exam. in house, undoubtedly one of the team would probably just break into the patient’s home. and then, there’s the investigation. in medicine, it’s often blood testing or imaging. and finally, there’s an answer. a diagnosis. to me, it was as clear as day. i sent paul medical journals that offer these little mysteries as both education and entertainment. © l ar ry d . m o o re c c b ysa 3 .0 paul tough 14 amwa journal / v36 n1 / 2021 / amwa.org journals like the new england journal of medicine, mayo clinic proceedings, the journal of the american medical association—this is what doctors do for fun, i explained. it took a while for the magazine to believe me. such a long while, that by the time it was all okayed, i had a different editor, dan zalewski, and he gave me the best single best piece of advice i ever got about choosing a story. he said, “write the stories that doctors would tell each other at the water cooler.” snap. got it. done. there’s one more editor who lent me a line i want to share with you. her name is catherine saint louis. she was my first long-term editor at the new york times magazine. of course, like dan, like paul, she’s long gone. she’s gone to a new medium, podcasting. so maybe, in retrospect, i shouldn’t be surprised that she should suggest i read my stories out loud before i turn them in. that was huge. out loud, the long wandering sentences leave you gasping, quite literally, and the clunky metaphors declare themselves as soon as they leave your lips. i have to say, after years of this practice, i don’t really know what i’ve written until i hear it from my own lips. thank you for the opportunity to share these stories and to honor a few of the many people who have helped me along the way. i know that all of us have these stories, and i’m glad to be able to share a few of mine. and i want to thank you for this wonderful honor and for including my name in the roster of all of the wonderful doctor–writers you’ve honored in the past. i wish i could be there. i wish we could all be there. but, we can’t. at least not now. but, enjoy the rest of your conference despite all that. it won’t last forever. thank you. acknowledgment i thank austin ulrich, pharmd, freelance medical writer (ulrichmedicalwriting.com) for his help in bringing the transcript to the page. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. general principles of word usage www.amwa.org/online_learning access today in amwa online learning. http://www.amwa.org/online_learning https://ulrichmedicalwriting.com/ contents v35 n2 summer 2020 107 58 figure 2. critical appraisal of hcp-targeted literature: role of medical writers medical writer mention drug to drug comparison and dose details mention random assignment, blinding details and comparability of groups mention study power, p value, and confidence intervalensure all endpoints (positive and negative) and all subgroup analyses are reported mention intention-totreat results mention absolute risk ratio and numbers needed to treat hcp, health care provider 51 research balancing science and promotion in medical writing � anita bhat and chinmayee joshi research outsourcing services of regulatory submission writing in the pharmaceutical industry � yan zhou feature icmje proposes a new author disclosure form for work submitted to medical journals � andrea blotta feature the ama manual of style: a guide for authors and editors—what’s new in the 11th edition � kelly schrank, stacy l. christiansen, and annette flanagin feature lifting the veil on compensation for employed medical communicators � roshawn watson around the career block strategies to advance your medical writing career part ii: identifying opportunities and developing skills � yanni wang and lindsey summers everyday ethics guiding ethical interactions with health care professionals: follow the codes � julie ravo freelance focus brian bass, lori de milto, cathryn d. evans, and ruwaida vakil why is confidence important in succeeding as a freelancer? how did you build your confidence? why is in-person networking still important in the digital age? 51 58 62 64 70 74 77 80 contents editor james r. cozzarin, els, mwc managing editor jennifer workman section editors around the career block lauren mcmahon, pharmd media and technology tara ann cartwright, phd practical matters qing zhou, phd, els regulatory insights jennifer bridgers, ms, mwc science series paul c. dolber, phd social media jennifer minarcik, ms statistically speaking thomas m. schindler, phd everyday ethics julie ravo, ba, ma members matters melory johnson, vn regular contributors freelance forum brian bass, mwc melissa l. bogen, els sherri bowen, ma, els lori de milto, mj cathryn d. evans gail flores, phd phyllis minick ruwaida vakil, msc, editor in the service of good writing laurie endicott thomas, ma, els editor at large haifa kassis, md editor emeritus lori l. alexander, mtpw, els, mwc editor in memoriam ronald j. sanchez 2019–2020 president ann winter-vann, phd 2019–2020 board liaison/ at-large director r. michelle sauer gehring, phd, els, cra 2019–2020 staff liaison shari rager, ms, cae executive director susan krug, ms, cae graphic designer amy boches, biographics editorial office: managingeditor@amwa.org. instructions for authors available at: www.amwa.org/journal. advertising: contact marketing@amwa.org or (240) 239-0940. all advertising is subject to acceptance by amwa and should be for products and services relevant to professional medical communicators. amwa is not responsible for the content of advertising and does not endorse any advertiser or its products or services. subscription: the amwa journal is published quarterly. subscription is included with amwa membership. nonmember subscriptions cost is $75 per year. contact: american medical writers association, 30 west gude drive, #525, rockville, md 20850-4347. phone: (240) 238-0940; fax: (301) 294-9006; email: amwa@amwa.org. the amwa journal is in the mla international bibliography and selectively indexed in the cumulative index to nursing and allied health literature (cinahl) print index and the cinahl database. the opinions expressed by authors contributing to the journal do not necessarily reflect the opinions of amwa or the institutions with which the authors are affiliated. the association accepts no responsibility for the opinions expressed by contributors to the journal. ©2020 american medical writers association. all rights reserved, worldwide. issn 1075-6361 amwa journal mission statement in support of the mission of the american medical writers association (amwa) and to advance the broader profession, the amwa journal publishes content that reflects the interests, concerns, and expertise of medical communicators. its purpose is to inform, inspire, and motivate medical communicators. m o r e v35 n2 / 2020 82 statistically speaking the evaluation of efficacy, or how do we know whether a treatment works? part 1 � thomas m. schindler and helen bridge 87 media and technology freedom to write: new tools for streamlining document development from start to finish � elizabeth clarke and krithi bindal 92 social media how social media helped prepare me for life in the time of corona � larry lynam 96 reprint predatory publishing – what medical communicators need to know � andrea bucceri, peter hornung, and thomas m. schindler 101 amwa news from the president � ann winter-vann american medical writers association annual financial report, 2018-2019 � julie l. phelan medical writer certified � david b. clemow amwa’s second medical writing executives forum: redefining talent acquisition, development, and engagement—ideas to action � cynthia l. kryder exciting news. #amwa2020 is going virtual! mary elizabeth williams, 2020 alvarez award recipient � elise eller amwajournal.org 29 amwa appreciates the participation and support from all our sponsors and exhibitors during the 2021 medical writing & communication conference. make plans to sponsor or exhibit at #amwa2022, november 2-5, 2022 in denver, co. learn more at https://www.amwa.org/exhibit_and_sponsor. silver level gold level exhibitors http://www.amwajournal.org https://www.amwa.org/exhibit_and_sponsor certara accelerates medicines using proprietary biosimulation software and technology-driven services to transform traditional drug discovery and development. its clients include more than 1,650 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 61 countries. regulatory writing on your terms. be part of a team driving regulatory success for groundbreaking medicines. flexible remote and hybrid roles supported by 250+ regulatory experts worldwide. visit www.certara.com/certara-careers © copyright certara 2022 copyright © 2022 merck & co., inc., kenilworth, nj, usa and its affiliates. all rights reserved. we share one vision and mission: to save and improve lives for more than a century, we have been inventing to solve some of the greatest challenges to people’s health and well-being around the world. today, we continue our commitment to be the premier research-intensive biopharmaceutical company in pursuit of medical breakthroughs that benefit patients and society for today, tomorrow and generations to come. our medical writing department strives to be the premier regulatory documentation organization in the biopharmaceutical industry. our medical writers are integral to helping bring medical breakthroughs to the world by developing high-quality deliverables that support the clinical regulatory writing portfolio. join our talented community in medical writing! click here to see our current openings, or email us at medicalwriting2@merck.com. ℠ we don't use numbers to identify our employees or our clients. we specialize in personal relationships that start with knowing your name. at wi, no one is a number. employee id engage with us at www.whitsellinnovations.com. b a n n i c k p r i m a r y . c o m clinical affairs regulatory affairs quality systems auditing medical writing: your strategic partner in medical device product development focused on us, eu and global regulations cep, cer, sscp & pmcf state-of-the-art summary (sota) scientific literature searches medical writing at icon early development writing quality review and editing regulatory publishing clinical trial transparency icon employs a dynamic, cross-functional team approach to medical writing. medical writers at icon are aligned to a single sponsor and work in a wide variety of clinical indications with more than one operating model supporting: interested? email your cv to ciasullomelissa@prahs.com written by an expert committee of jama network editors, the 11th edition ama manual of style is a must-have resource for everyone involved in medical, health, and scientific publishing. updates include: • updated guidance on language used to report race and ethnicity • citation guidelines for digital publications • medical nomenclature and preferred usage • new list of study types and reporting guidelines • a full-color chapter on data display in tables and figures • expanded chapter on statistics amwa members get 20% off the print edition or print/online bundle to purchase, visit oup.com/academic and enter code amwa20 at the checkout contents v36 n1 spring 2021amwa annual financial report, 2019-2020 julie phelan, md, mba / 2019-2020 amwa treasurer it has been a pleasure servicing as treasurer for the american medical writers association (amwa) over the past year, and i am pleased to provide this financial report for the 2019-2020 fiscal year, which ended june 30, 2020. i begin this report acknowledging that during the last 2 quarters of the fiscal year, the covid-19 pandemic caused severe disruption to everyday life and a recession. the leadership of amwa quickly put a plan in place to minimize the impact of the pandemic. amwa staff successfully converted to a remote work environment, and expenses were curtailed. meetings and travel plans were cancelled, and vacant staff positions were put on hold. the success of the 2019 annual conference in san diego, popularity of live webinars, increase in membership, and careful management of expenses helped to sustain amwa through this uncertain time. the full financial effects of the covid-19 pandemic may not be experienced until next year. financial performance amwa’s net income for the 2019-2020 fiscal year was $448,106, with significant investment gains contributing to the results. revenues overall, revenues exceeded budget expectations by 6%, largely because of the success of the annual conference. membership income, annual conference income, and education and certificate program income continue to be amwa’s major sources of revenue, providing 89% of amwa’s program revenue. net investment income of $115,074 accounted for 5% of amwa’s total revenue (figure 1). figure 1. sources of program revenue for the fiscal year that ended june 30, 2020. membership 35% annual conference 38% education/certificate program 16% all other revenue 11% 52 48 30 3 4 7 11 15 26 30 from the president 2020 conference coverage freelance focus: jam session for seasoned freelancers � brian bass, with commentary from cathryn d. evans, sherri bowen, and melissa l. bogen walter c. alvarez award address: every person is a patient: finding the story in the science � mary elizabeth williams john p. mcgovern award address: learning curves � lisa sanders session reports: • tricks and tips for time management • low-cost and low-effort ways to create infographics and visually appealing slides • a powerful combination: the value of the writer-editor partnership • editing: hard knowledge, soft skills • collaborative writing: ensure success with an effective strategy • strategies for effective risk communication • mentoring programs: one size may not fit all • analysis of mentoring: from marginal to maximal • knowing which button to push: communicating the value proposition of medical writing • what the best medical writers know about nonclinical data exhibitor precis feature cabells scholarly analytics is a force of knowledge against predatory publishing—an interview with simon linacre � mary kemper contents interim editor-in-chief shari rager, ms, cae managing editor jennifer workman section editors around the career block lauren mcmahon, pharmd media and technology tara ann cartwright, phd practical matters qing zhou, phd, els regulatory insights jennifer bridgers, ms, mwc science series paul c. dolber, phd social media jennifer minarcik, ms statistically speaking thomas m. schindler, phd everyday ethics julie ravo, ba, ma members matters govindi (jaya) samaranayake, phd regular contributors freelance focus ruwaida vakil, msc brian bass, mwc melissa l. bogen, els sherri bowen, ma, els lori de milto, mj cathryn d. evans gail v. flores, phd phyllis minick in the service of good writing laurie endicott thomas, ma, els editor at large haifa kassis, md editor emeritus lori l. alexander, mtpw, els, mwc editor in memoriam ronald j. sanchez 2020–2021 president gail v. flores, phd 2020–2021 board liaison r. michelle sauer gehring, phd, els, cra 2020–2021 staff liaison shari rager, ms, cae executive director susan krug, ms, cae graphic designer amy boches, biographics editorial office: managingeditor@amwa.org. instructions for authors available at: www.amwa.org/journal. advertising: contact marketing@amwa.org or (240) 239-0940. all advertising is subject to acceptance by amwa and should be for products and services relevant to professional medical communicators. amwa is not responsible for the content of advertising and does not endorse any advertiser or its products or services. subscription: the amwa journal is published quarterly. subscription is included with amwa membership. nonmember subscriptions cost is $75 per year. contact: american medical writers association, 30 west gude drive, #525, rockville, md 20850-4347. phone: (240) 238-0940; fax: (301) 294-9006; email: amwa@amwa.org. the amwa journal is in the mla international bibliography and selectively indexed in the cumulative index to nursing and allied health literature (cinahl) print index and the cinahl database. the opinions expressed by authors contributing to the journal do not necessarily reflect the opinions of amwa or the institutions with which the authors are affiliated. the association accepts no responsibility for the opinions expressed by contributors to the journal. ©2021 american medical writers association. all rights reserved, worldwide. issn 1075-6361 amwa journal mission statement in support of the mission of the american medical writers association (amwa) and to advance the broader profession, the amwa journal publishes content that reflects the interests, concerns, and expertise of medical communicators. its purpose is to inform, inspire, and motivate medical communicators. m o r e v36 n1 / 2021 34 statistically speaking the evaluation of effectiveness, or how do we know whether a treatment works in real life? part 2 � thomas m. schindler and helen bridge 39 practical matters leadership behind the scenes: a backstage approach to effective medical writing � katie bates, dwyn desilver, and cathi harmon 43 around the career block journey from veterinary medicine to medical writing � joanna pendergrass 45 in the service of good writing metaphorically speaking � laurie endicott thomas 47 calendar of meetings 48 members matters making history: an interview with katrina burton, amwa’s new president-elect � joanna pendergrass 51 amwa news 2020 annual business meeting for amwa members � katrina burton amwa annual financial report, 2019-2020 � julie phelan 80th anniversary donors v37 n3 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 11 abstract some continuing medical education (cme) activities are developed using financial support from entities such as pharmaceutical companies that may have a commercial interest in the therapeutic area being discussed. accordingly, standards intended to shield cme from industry bias have been in place for decades. the latest iteration of these standards from the accreditation council for continuing medical education (accme) has a special significance to medical writers due to their emphasis on clinical content validity. once a separate entity, the content validity requirement is now incorporated into the accme standards. in fact, it is positioned as the number 1 standard, emphasizing its importance. it should be relatively straightforward for writers to support the goals of the guidance—that is, to provide relevant and scientifically accurate content that is free from industry manipulation or influence. however, the standards as published are not prescriptive in how to achieve these goals, leaving writers to ponder exactly what it means to be “fair and balanced.” this article provides background on the accme standards with a special emphasis on their relevance to cme writers, describes helpful downloadable resources for writers, discusses some scenarios that medical writers may encounter, and provides practical advice in interpreting and applying the current standards when developing content for cme activities. medical writers are instrumental in the development of continuing medical education (cme) content. the key opinion leaders and expert faculty members may get premier placement on the marquee, but it is often the medical writer (staff or freelancer) generating the manuscript text, powerpoint slides, clinical multiple-choice questions, interactive patient cases, animation storyboards, video and podcast scripts, and other scientific content that helps drive improvements in clinician knowledge, competence, and performance. these cme writing assignments are often rigid and flexible at the same time. medical writers may be asked to stay within the guardrails of preexisting learning objectives and content outlines, and their work is typically subject to multiple reviews by faculty experts, peer reviewers, and cme providers. even so, writers often find themselves in the position of making high-level decisions regarding content direction, often entirely on their own, or with a minimum of guidance. the nature of cme content decisions that medical writers tackle independently can vary widely. one day, it’s selecting citable peer-reviewed sources for a pdf monograph on best practices in diabetes management. the next day, it’s describing the complexities of therapeutic selection in a powerpoint deck on relapsed/refractory multiple myeloma—a disease state in which (at last count) there were 30 reasonable multidrug regimens to choose from, depending on the number and type of previous treatments given.1 this task of content decision making becomes even more challenging when writers consider the potential for bias in the materials they are developing. many cmerelated writing assignments are to provide content for activities that are supported—that is to say, developed using a financial grant from a company or companies that likely have a commercial interest in the therapeutic area. thus, direct industry support for an activity is a potential source of bias (although not the only source, eg, faculty may have their own conflicts of interest that need to be resolved). although data from the accreditation council for continuing medical education (accme) indicate that the vast majority of accredited educational activities (upwards of 90%) receive no commercial support at all, the total sum of grant funding is nevertheless large. accredited providers have reported more than $700 million per year in commercial support since 2016 with a grand total of nearly $723 million in 2020, the most recent year for which this statistic is available.2 with those kinds of numbers in mind, medical writers have a considerable responsibility to help ensure that supported cme content is scientifically sound and devoid of industry manipulation or influence. toward that end, standards have been promulgated by the accme, the nonprofit andrew d. bowser, els, chcp / iconcme, philadelphia, pa avoiding bias and ensuring content validity in accredited continuing education: what do the latest accme standards mean for medical writers? ce craft corner http://www.amwajournal.org amwajournal.org 12avoiding bias and ensuring content validity that accredits organizations that offer cme and recognizes state medical societies as accreditors of local cme programs. navigating commercial interests the first set of accme standards intended to guide the cmeindustry relationship was released in 1992, and in 2004, more stringent standards were put in place to ensure the independence of cme activities, particularly with regard to conflict of interest. the latest iteration, “standards for integrity and independence in accredited continuing education,”3 was released in december 2020 and has been adopted by 7 additional accrediting bodies across multiple health professions. as of january 1, 2022, all providers in the accme system are expected to comply with the new standards. medical writers should take note of how content validity is central to the new accme standards (table 1). in a viewpoint published in jama, accme president graham mcmahon, md, mmsc, explained that content validity requirements had been part of accme policy for many years, but separately from the standards. now, mcmahon said, content validity is included as the very first standard, which was intentionally done to emphasize its significance: “with the proliferation of medical misinformation and disinformation, as well as questions about the validity of science, issues related to content validity are more important than ever.”4 in a nutshell, the expectations for content validity are as follows: • recommendations for patient care have to be based on current scientific evidence and clinical reasoning while providing a fair and balanced view of options for diagnosis and treatment. • any scientific research used to support or justify a patient care recommendation has to conform to generally accepted standards for study design, data collection methods, analysis, and interpretation. • although discussion and debate are appropriate, the education can’t advocate or promote practices that are not firmly based on current scientific evidence and clinical reasoning. • on a related note, the education cannot advocate for unscientific approaches or medical practices that are known to be ineffective, or have risks that outweigh the benefits. applying the accme standards those requirements may sound straightforward on paper, but they are sometimes challenging to apply in actual dayto-day medical writing practice. the accme does offer some helpful general advice on best practices (table 2) along with a helpful peer review checklist available for download. for example, multiple perspectives can be table 1. new accme standards for integrity and independence in accredited continuing education standard applicability accredited provider responsibility 1. ensure content is valid all accredited ce ensure that education is fair and balanced, and that any clinical content presented supports safe, effective patient care 2. prevent commercial bias and marketing in accredited ce all accredited ce protect learners from commercial bias and marketing in accredited ce 3. identify, mitigate, and disclose relevant financial relationships all accredited ce identify relevant financial relationships between individuals in control of educational content and ineligible companiesa and managing these to ensure they do not introduce commercial bias 4. manage commercial support appropriately accredited ce that receives financial or in-kind support from ineligible companies ensure that the education remains independent of the ineligible company and that the support does not result in commercial bias or commercial influence 5. manage ancillary activities offered in conjunction with accredited ce when there is marketing by ineligible companies or nonaccredited education associated with the accredited ce ensure that education is separate from marketing by ineligible companiesb and from nonaccredited education offered in conjunction with accredited continuing education ce, continuing education. aan ineligible company is a company ineligible to be accredited in the accme system; their primary business is producing, marketing, selling, re-selling, or distributing health care products used by or on patients. bincludes advertising, sales, exhibits, and promotion. adapted from standards for integrity and independence in accredited continuing education. copyright 2020 by the accme. http://www.amwajournal.org amwajournal.org 13avoiding bias and ensuring content validity provided to address a clinical question in which there is considerable debate (eg, “should routine colorectal cancer screening begin at age 45?”).5 however, many questions remain that are not necessarily covered in detail in formal guidance. for example, • if one treatment is discussed in detail, does that mean others need equal coverage in order to be fair and balanced? • what if there is only 1 relevant treatment for a specific disease state covered in the education? • is it strictly forbidden to use brand names for drugs? and if so, what do i do when the use of generic descriptors is overly complicated or confusing? • can i cite a company press release? and if not, how do i properly cite research that apparently hasn’t been published or presented yet? i consulted several medical writers and others with cme experience (see acknowledgement) to review possible solutions to these and other issues. a summary is below. first, however, it’s important to emphasize that it is generally not all on the medical writer’s shoulders to parse out difficult situations regarding fair balance, potential conflicts of interest, or other issues. on the contrary, it is the accredited provider of the educational activity that is ultimately responsible for ensuring that the overall activity is in alignment with the accme standards. the staff of the accredited provider should be skilled and experienced in applying the accme standards and can be an excellent resource for anyone who is involved in cme content creation or execution. accordingly, writers are strongly encouraged to reach out to the accredited provider for the activity when they are unsure how to proceed. ideally, this would occur early on rather than later in the content development process, especially so that carefully crafted content isn’t unexpectedly sidelined by content revision needs at the last minute. although the following tips should not be taken as gospel or unassailable expert advice, they may offer a path forward that may be acceptable for your dilemmas regarding content validity: provide fair balance—but not necessarily equal time. although it’s important to avoid focusing on a specific treatment and to discuss efficacy as well as safety data, there is no need to discuss each treatment option with exactly the same emphasis. let the strength of evidence and us food and drug administration (fda)-approved indications guide the weight of discussion. for example, 2 treatments for a specific dermatologic condition may appear to have similar rates of response and tolerability, although upon closer inspection, the evidence for treatment a is from a randomized, placebo-controlled phase 3 trial, whereas treatment b is supported by a single-arm phase 2 trial. furthermore, treatment a may have a specific fda indication for the dermatologic condition, whereas treatment b is used off-label to treat the condition (off-label use is common and sometimes necessary, but the education should be upfront about that, and ideally refer to the evidence supporting the unapproved usage).6 high-quality review articles and clinical practice guidelines may offer clues in terms of cataloging the evidence to date, although caution is advised in relying on stale information, particularly in fast-moving areas like immuno-oncology in which new data are always a meeting away (or less). in some cases, a therapeutic area may be so underserved that there is only 1 relevant emerging or novel treatment option (eg, in a rare disease in which the previous standard of care was supportive care). in that case, providing fair balance may be a discussion of emerging therapeutic options in earlier stages of clinical investigation. failing that, balance can be provided by ensuring adequate discussion of the potential risks of therapy alongside the potential benefits (as is good practice for cme writing in any case). table 2. new accme standards for integrity and independence in accredited continuing education focus area recommendation level of evidence clearly describe the level of evidence on which the presentation is based and provide enough information about data (study dates, design, etc.) to enable learners to assess research validity sources ensure that, if there is a range of evidence, that the credible sources cited present a balanced view of the evidence recommendations if clinical recommendations will be made, include balanced information on all available therapeutic options risks and adverse effects address any potential risks or adverse effects that could be caused with any clinical recommendations evidence base if the evidence base is low (or absent) for a topic or treatment, consider alternate strategies, eg, a debate or dialogue between multiple faculty representing a range of opinions and perspectives adapted from the toolkit for the standards for integrity and independence in accredited continuing education. copyright 2020 by the accme. http://www.amwajournal.org amwajournal.org 14avoiding bias and ensuring content validity cite credible and acceptable sources. experienced cme writers generally recognize a hierarchy of evidence and sources, although caveats apply at each level: • peer-reviewed and pubmed-indexed medical journal articles are usually considered highly citable, but some judgment is required on the part of the writer, as not all peer-reviewed research is of high quality, and not all journals are as impactful as others (did that promising-looking study end up in the new england journal of medicine or in a little-known journal?). • clinical practice guidelines also rank high, particularly if provided by well-known medical societies or organizations (such as the american heart association), although not all guidelines are rigorously developed. look for methodologies such as the grade (grading of recommendations, assessment, development, and evaluations) system, which can be used to evaluate evidence quality and quantify the strength of health care recommendations.7 • medical meeting presentations are generally considered fair game. however, the information in a meeting abstract may not be peer reviewed. in addition, the conclusions of the research may change substantially from the submission of a meeting abstract to the actual meeting presentation, and sometimes, to the subsequent publication of those results in a peer reviewed journal. • many agree that company press releases are not appropriate to cite, although as a result, it can be tricky to develop a state-of-the-art cme presentation when a potentially practice-changing clinical trial result is available only in the form of a press release. although there are no easy solutions, one approach may be to reference publicly available details of the clinical trial design (eg, from the clinicaltrials.gov database) and state in the activity that published/presented results are awaited. avoid corporate logos and (usually) brand names. when it comes to avoiding industry influence in cme activities, it’s a no-brainer to omit corporate logos, and it’s considered best practice to eschew brand names—although this is not always straightforward or without challenges. medical devices, biosimilars, and proprietary formulations of common drugs are just 3 of the categories of products that are sometimes difficult to discuss without dropping brand names. the covid-19 vaccines present a new wrinkle, as they are widely referred to by the manufacturer’s name, so many learners won’t immediately know whether the pfizer mrna vaccine is bnt162b2, mrna-1273, or ad26.cov2.s (it’s bnt162b2). finally, some audiences may know a specific drug only by its brand name, making education based on generic names an uphill battle. if the brand name can’t be avoided, make sure to apply the standard equally, for example, don’t use a brand name for one drug and a generic name for the others. don’t forget about the other standards. content validity is just 1 puzzle piece (although an important one) in the new accme standards for integrity and independence in accredited continuing education. there are important intersections between this guidance and the medical writer’s work. writers should make sure that disclosure information, including their own, is provided in the activity they are developing (standard 3: identify, mitigate, and disclose relevant financial relationships), and may need to solicit that information if it’s not already available. another example: a faculty member tries to add a powerpoint slide that their local drug rep said would be “just perfect” for the accredited activity; the writer should decline and remind faculty that decisions regarding the education must be made without influence or involvement from pharmaceutical company employees (standard 2: prevent commercial bias and marketing in accredited ce). conclusion medical writers are often on the front lines of developing accredited continuing education. accordingly, writers must help ensure that the fundamental principles of integrity and independence govern the development of specific educational activities. toward that end, writers should have a thorough working knowledge of the latest accme standards for integrity and independence in accredited continuing education. reviewing available accme resources (including the aforementioned guidance and checklist for clinical content validity) will help writers apply the standards to their current projects and navigate some of the nuances described in this article. with that background, medical writers will be better prepared to develop clinical cme content that is fair and balanced, unbiased, and supportive of safe and effective patient care. acknowledgement the author thanks the following individuals for their insights and perspectives on the topic of this article: • esther l. langmack, md, fccp, chcp, langmack medical communications llc • jan schultz, msn, rn, facehp, chcp, jan schultz associates • alexandra howson ma, phd, chcp, thistle editorial, llc http://www.amwajournal.org http://clinicaltrials.gov amwajournal.org 15avoiding bias and ensuring content validity • eve johnson wilson, phd, chcp, facehp, platformq health • donald harting, ma, ms, els, chcp, harting communications llc author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: abowser@iconcme.com references 1. national comprehensive cancer network. multiple myeloma. version 5. national comprehensive cancer network; 2022. accessed april 28, 2022. https://www.nccn.org/professionals/ physician_gls/pdf/myeloma.pdf 2. accreditation council for continuing medical education. accme data report: rising to the challenge in accredited continuing education 2020. accme; 2021. accessed april 28, 2022. https://www.accme.org/sites/default/files/202106/902_20210615_2020%20data%20report.pdf 3. accreditation council for continuing medical education. standards for integrity and independence in accredited continuing education. accme; 2020. accessed april 28, 2022. https:// accme.org/sites/default/files/2021-06/884_20210624_new%20 standards%20standalone%20package.pdf 4. mcmahon gt. changes to the standards for integrity and independence in continuing medical education. jama. published online april 15, 2021. doi:10.1001/jama.2021.0213 5. wender rc. should routine screening for colorectal cancer start at 45 years of age? yes: lowering the starting age is a settled issue. am fam physician. 2022;105(2):120–121. 6. united states food and drug administration. understanding unapproved use of approved drugs “off label.” us food and drug administration website. updated february 5, 2018. accessed may 19, 2022. https://www.fda.gov/patients/learn-aboutexpanded-access-and-other-treatment-options/understandingunapproved-use-approved-drugs-label 7. brozek jl, akl ea, alonso-coello p, et al. grading quality of evidence and strength of recommendations in clinical practice guidelines. part 1 of 3. an overview of the grade approach and grading quality of evidence about interventions. allergy. 2009;64(5):669–677. resources • accme standards for integrity and independence in accredited continuing education (pdf) • toolkit for the standards for integrity and independence (in particular, pages 7-8, “guidance for planners, authors, and faculty: ensuring that clinical content is valid”) unlock the secrets to freelance success with this 3-part on-demand video series. gain relevant and practical advice from industry pros. run your business like a pro. • essential ingredients of a successful freelance business • bad behaviors that can sabotage your business • getting the clients you deserve unlock now in amwa online learning: www.amwa.org/freelance_success http://www.amwajournal.org https://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf https://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf https://www.accme.org/sites/default/files/2021-06/902_20210615_2020%20data%20report.pdf https://www.accme.org/sites/default/files/2021-06/902_20210615_2020%20data%20report.pdf https://accme.org/sites/default/files/2021-06/884_20210624_new%20standards%20standalone%20package.pdf https://accme.org/sites/default/files/2021-06/884_20210624_new%20standards%20standalone%20package.pdf https://accme.org/sites/default/files/2021-06/884_20210624_new%20standards%20standalone%20package.pdf https://jamanetwork.com/journals/jama/article-abstract/2778925 https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label https://accme.org/sites/default/files/2021-06/884_20210624_new%20standards%20standalone%20package.pdf https://accme.org/sites/default/files/2021-06/884_20210624_new%20standards%20standalone%20package.pdf https://accme.org/sites/default/files/2020-12/883_20201210_standards%20for%20integrity%20and%20independence%20toolkit.pdf https://accme.org/sites/default/files/2020-12/883_20201210_standards%20for%20integrity%20and%20independence%20toolkit.pdf amwa journal / v36 n4 / 2021 / amwa.org 163 lafond, adam lach-szyrma, and javier inductivo for inspiring conversations about creativity in medical communication and to haifa kassis for feedback and recommendations to improve this piece. author declaration and disclosures: the views and opinions expressed herein are those of the author and do not necessarily reflect the views of area 23, its affiliates, or its employees. the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: caricilli@gmail.com references 1. lipworth k, cuozzo s, jones b. how medcomms has risen to the covid-19 challenge. the difference collective website. published june 10, 2020. accessed september 8, 2021. https:// thedifferencecollective.com/medcomms-rises-to-the-covid-19challenge/ 2. graham m. how a stay-at-home year accelerated three trends in the advertising industry. cnbc website. published march 13, 2021. accessed september 8, 2021. https://www.cnbc.com/2021/03/13/ how-covid-19-changed-the-advertising-industry-.html 3. veksner s. how to make it as an advertising creative. london: laurence king publishing ltd; 2010. 4. how to create a good advertising brief. digital school of marketing website. published december 10, 2019. accessed september 9, 2021. https://digitalschoolofmarketing.co.za/blog/how-to-develop-agood-advertising-brief/ 5. amwa code of ethics. american medical writers association website. updated june 2008. accessed september 12, 2021. https:// www.amwa.org/general/custom.asp?page=code_of_ethics 6. the office of prescription drug promotion. us food and drug administration website. updated july 1, 2021. accessed september 11, 2021. https://www.fda.gov/about-fda/center-drug-evaluationand-research-cder/office-prescription-drug-promotion-opdp 7. dankiewicz e. time to review your promotional review? best practices in the us. dia website. accessed september 12, 2021. https://globalforum.diaglobal.org/issue/april-2021/time-to-reviewyour-promotional-review/ 8. ross c. creativity in health communications. pmgroup website. published december 10, 2014. accessed september 1, 2021. http://www.pmlive.com/pharma_news/creativity_in_health_ communications_617873 9. angoff nr. making a place for emotions in medicine. yale j health policy law ethics. 2002;2(2):8. https://digitalcommons.law.yale.edu/ yjhple/vol2/iss2/8 alliance for continuing education in the health professions january 12-15, 2022 aurora, colorado https://www.acehp.org/annual-conference european meeting of ismpp january 25-26, 2022 london, uk https://www.ismpp.org/european-meeting american association for the advancement of science february 17-20, 2022 philadelphia, pennsylvania, and virtual https://meetings.aaas.org/ apha annual meeting & exposition march 18-21, 2022 san antonio, tx https://aphameeting.pharmacist.com dia europe 2022 march 29-31, 2022 brussels, belgium, and virtual https://www.diaglobal.org/en/flagship/dia-europe-2022 aces annual national conference march 31 – april 2, 2022 san antonio, tx https://aceseditors.org/conference/ annual meeting of ismpp may 9-11, 2022 washington, dc https://www.ismpp.org/annual-meeting stc technical communication summit may 15-18, 2022 virtual https://summit.stc.org dia 2022 global annual meeting june 19-23, 2022 chicago, il https://www.diaglobal.org/flagship/dia-2022 calendar of meetings please confirm with individual meeting hosts https://www.acehp.org/annual-conference https://digitalcommons.law.yale.edu/yjhple/vol2/iss2/8 mailto:caricilli@gmail.com https://thedifferencecollective.com/medcomms-rises-to-the-covid-19-challenge/ https://thedifferencecollective.com/medcomms-rises-to-the-covid-19-challenge/ https://thedifferencecollective.com/medcomms-rises-to-the-covid-19-challenge/ https://www.cnbc.com/2021/03/13/how-covid-19-changed-the-advertising-industry-.html https://digitalschoolofmarketing.co.za/blog/how-to-develop-a-good-advertising-brief/ https://digitalschoolofmarketing.co.za/blog/how-to-develop-a-good-advertising-brief/ https://digitalschoolofmarketing.co.za/blog/how-to-develop-a-good-advertising-brief/ https://www.amwa.org/general/custom.asp?page=code_of_ethics https://www.amwa.org/general/custom.asp?page=code_of_ethics https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp https://globalforum.diaglobal.org/issue/april-2021/time-to-review-your-promotional-review/ https://globalforum.diaglobal.org/issue/april-2021/time-to-review-your-promotional-review/ https://globalforum.diaglobal.org/issue/april-2021/time-to-review-your-promotional-review/ http://www.pmlive.com/pharma_news/creativity_in_health_communications_617873 https://www.ismpp.org/european-meeting https://meetings.aaas.org/ https://aphameeting.pharmacist.com https://www.diaglobal.org/en/flagship/dia-europe-2022 https://aceseditors.org/conference/ https://www.ismpp.org/annual-meeting https://summit.stc.org https://www.diaglobal.org/flagship/dia-2022 v38 n1 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 45 abstract medical writing is a process that generates a variety of documents in the biomedical domain, including but not limited to clinical reports, regulatory reports, protocol documents, patient narratives, plain language summaries, and so on.1 medical writing is complex and time-consuming because a writer must refer to multiple sources, sift through a large volume of documents, maintain data integrity, perform review of literature, do interpretation of results, summarize, and so on. these challenges can be addressed and minimized substantially by adopting artificial intelligence, specifically cognitive search, natural language processing (nlp), and natural language generation (nlg) models and other techniques. given the recent advances in language models for nlg, the time is ripe for a product in the medical writing domain that integrates and automates search capabilities, provides cognitive processing, and generates content using nlg. this white paper takes scientific manuscript writing as an example to provide insights into the way nlp and nlg can augment, automate, and expedite the process of writing a wide variety of biomedical documents. it looks at the current limitations of technology and ways to address those. finally, it provides recommendations on how these technologies can be used to create a single system or product. such an approach has the potential to expand into multiple areas in the biomedical domain, with medical writing as the first challenge. introduction current medical writing market according to grand view research, the global medical writing market size that was valued at us $3.4 billion in 2019 is expected to expand to us $7.77 billion by 2027 at a compound annual growth rate of 10.9%.2 the cost spent on content generation continues to rise. existing medical writing process medical writing is a complex and manually intensive process. the process of medical writing involves the following steps a) understanding the content brief b) review of literature c) collation of the results, methods, and discussion sections deepak palasamudram1; karun s. karunakaran2; prakhar gaur3; akshatha miyal kamath2; pramit saha4; tina purushotam5/ 1associate vice president, architecture and design group, healthcare, insurance and life sciences, infosys limited, india; 2architect, architecture and design group, healthcare, insurance and life sciences, infosys limited, india; 3consultant, life sciences domain consulting group, infosys limited, india; 4project manager, architecture and design group, healthcare, insurance and life sciences, infosys limited, india; 5digital specialist engineer, architecture and design group, healthcare, insurance and life sciences, infosys limited, india leveraging artificial intelligence, natural language processing, and natural language generation in medical writing article glossary natural language processing (nlp): the branch of artificial intelligence (ai) that enables computers to process human language and understand the meaning, intent, and sentiment of the text, much like a human being can. natural language generation (nlg): the branch of ai that enables computers to produce human language that approximates content generated by a human being. recommendation model: a system that uses machine learning to predict content that is relevant for a user in a given context. the predictions are often combined with a ranking system that enables users to see the most relevant recommendations first. named entity recognition (ner): a process by which text is classified into predefined categories like drug name, disease name, location. also, depending on the context, it can differentiate between “apple” (fruit) and “apple” (corporation). large language model (llm): large language models (llms) are artificial intelligence tools that can read, summarize and translate texts and predict future words in a sentence letting them generate sentences similar to how humans talk and write.11 eg., gpt-3, gpt-j, bart, bert, t5. natural language query understanding (nlqu): this is a capability of the search system to understand a search query written in natural language. this is achieved by llm based search systems. eg. “what is the second largest land animal in the world?” http://www.amwajournal.org amwajournal.org 46leveraging ai, nlp, and nlg in medical writing d) authoring the manuscript and maintenance of data integrity in the process e) reviewing the authored content f) copy editing g) approval and sign off h) electronic publishing medical writers spend 2 to 3 weeks researching across multiple data sources and a large corpus of documents (nearly 1 million new articles are added yearly to just pubmed).3 the review of literature is the most time-consuming step in the medical writing process. this requires a domain expert to first search for and then read through the text of the articles on a particular subject area. the goal of this step is to synthesize the existing knowledge in a particular subject area. in the case of writing a scientific manuscript for a clinical trial, the review of literature must cover several subtopics in the therapy area of concern. all the subtopics require individualized search strategies irrespective of the therapeutic area. medical writers use several literature databases like pubmed, scopus, ovid, and cochrane. this also introduces the risk of missing out on relevant literature, making this task not only time-consuming, but also errorprone. the aforementioned tasks require multiple individuals to complete it in a reasonable amount of time, each one concentrating on a particular subset of the overall document. the final challenge lies with the summarization step, when information gleaned from several published articles is summarized. the risks here are missing the important points as well as accidentally not including a relevant reference. in writing the results section of a manuscript, data may need to be collated from a source document like a clinical study report (csr) and adding it to the manuscript in a particular format. this can involve aggregating and summarizing the data, creating plots, or writing a narrative for a particular set of data. a great example are the tables for adverse events. this step may introduce quality issues if not done carefully. obviously, the power of using a computer to automate data analytics is well known, and natural language generation (nlg) provides tools to create narratives summarizing tabular data accurately. products with authoring workflows that allow collaboration on a single document by multiple people have been in use for more than a decade.4 in addition to these, functionalities like referencing and text formatting according to journal requirements have also been in use. these capabilities can come from various tools and techniques, which would require integration of many products or tools into a single system. role of artificial intelligence in medical writing a system that can automate and assist with these tasks would help mitigate many of the challenges and risks described before. artificial intelligence (ai) has several interesting possibilities for transforming any industry. nowhere are its applications more relevant than for life sciences and pharmaceutical, regulatory, and medical writing for creating documents such as scientific manuscripts, fact sheets, literature reviews, disease awareness, and oral posters. a canonical use case for the application of ai is the process of the review of literature that is done as part of research work. in the review of literature process, the researcher is required to use their language and domain knowledge to summarize the various published articles on a topic. this is done to summarize the state of the art in the field. nlg models are being used to automate this step; at the same time, manual intervention is required before the machine-generated text can be submitted for publication. many functionalities are required to automate the medical writing process that are elaborated on in the following sections. cognitive search for literature survey and recommendation the review of literature requires multiple subtopics in a disease/therapeutic area to be comprehensively covered. this requires individualized search strategies for each subtopic, with the search itself carried out across multiple databases. the next task is to read through the top hits for each subtopic to identify the relevant content in that published article. ai or machine learning (ml) can help in automating the literature search, content extraction, content enrichment (which includes named entity recognition [ner]), and intent detection in the context of life sciences and pharmaceuticals. this enables advanced unified searching across multiple data sources and databases. secondly, once trained, the recommendation models are used to identify the relevant sentences or paragraphs in the articles. automation of this step can enhance efficiency of the most time-consuming component in the literature review process. in addition to automation, the system can perform citation management, an essential part of any medical or technical document. leveraging ai, nlp, and nlg in medical writing http://www.amwajournal.org amwajournal.org 47leveraging ai, nlp, and nlg in medical writing narrative generation the generation of narratives from structured data by applying nlg has been in the life sciences domain for more than a decade. previously, it was done using hardcoded text as part of code, and now, nlg models can generate text up front for the structured data that is being processed. the text or narrative generated by the nlg model can, depending on the models used, involve ml algorithms (deep learning) or preset parameters. the output from either of these or a combination of both is a narrative as would have been written by a medical writer.5 summarization the most recent developments in the nlg space have enabled models to summarize large texts. the initial models were trained and built using news articles because they provide human-generated text and summaries. now, models are being trained on the published medical corpus available as peer-reviewed scientific articles. further refinement of the models specific to diseases and drugs are needed in automating medical writing. there are 2 types of summarization techniques possible using nlg models: extractive and abstractive. extractive summarization involves identifying important subsets of sentences from the original text in toto and forming a summary comprising such sentences. this type of summarization is useful if the author decides to select multiple sources from the recommendations and to rewrite the text on their own after the summary gets generated. abstractive summarization reproduces important material in a new way after examination and interprets the text using nlg capabilities, simulating how humans do a review of literature.6,7 abstractive summarization mimics how an author would write a synthesis of existing literature in their own words along with the references used. examples of such models include gpt-3, t5, berts, and barts.8 abstractive summary is useful when the authors want an abstract of the selected recommendations. this kind of summary, along with reference metadata, addresses issues related to plagiarism because this is not an exact reproduction of text from the sources but a generation of original text. figure 1 depicts one such example of extractive and abstractive summarizations. key challenges in applying ai to medical writing the key challenges to applying ai in medical writing include • ingesting documents from diverse sources and variety of formats. apart from a pharmaceutical company’s internal data sources, there are multiple external sources like pubmed articles, regulatory documents, clinical trial documents, protocols, clinical study reports, and press releases. this necessitates dealing with different document formats and structures like native pdfs, docx, xml, html, and scanned documents. • understanding document semantics and content, extracting key entities unambiguously, capturing synonyms based on scientific ontologies, identifying contexts and intents from medical content in the context of life sciences and pharmaceuticals. this requires compositional semantic analysis that includes word sense disambiguation and relationship extraction that is relevant in biomedical literature. • reranking cognitive search results for better search relevance. this requires adoption of learning to rank figure 1. extractive and abstractive summaries from given input text. '\ extractive summarization: psoriasis vulgaris is a chronic inflammatory condition associated with significant morbidity and mortality. plaque psoriasis is the most common form of psoriasis vulgaris and classically presents as discrete, erythematous plaques with an overlying silvery scale on extensor surfaces. ./ " input: psoriasis vulgaris is a chronic inflammatory condition associated with significant morbidity and mortality. plaque psoriasis is the most common form of psoriasis vulgaris and classically presents as discrete, erythematous plaques with an overlying silvery scale on extensor surfaces. the most common form of psoriasis is chronic plaque psoriasis, which is characterized by stable and localized erythematous scaly plaques that are well demarcated from normal skin. psoriasis is a common inflammatory skin disease that causes significant stress and morbidity. abstractive summarization: psoriasis vulgaris (psv) is a chronic inflammatory skin disease characterized by erythematous scaly plaques with an overlying silvery scale on extensor surfaces. / http://www.amwajournal.org amwajournal.org 48leveraging ai, nlp, and nlg in medical writing also know as machine-learned ranking. this process re-ranks results from search engines in the medical writing context for content such as the mechanism of action for drugs or disease epidemiology, etc.9 • combining multiple modes of intelligence such as natural language processing (nlp), nlg, deep learning, language models, lexicons, and ontologies into a state-of-the-art ai-based platform for medical writing. • removing biases from algorithms. potential biases can creep in at various steps, from the curation of training datasets, to feature engineering, model choice, and implementation. detecting and removing algorithmic biases will entail evaluating it via a thorough understanding of the algorithm’s role and the context in which it is deployed. bringing it all together as discussed earlier, one of the objectives of this article is to define the architecture and components of a system or product that will automate the process of medical writing significantly. such a system should have the end-to-end ability to ingest documents, identify the entities in those documents, provide them as search results based on user queries, and generate summaries based on user-selected documents. these features require adoption of the various ai techniques discussed previously. ai horizons have seen a strategic shift from conventional ml (with a focus on augmenting intelligence) to deep learning (enabling higher accuracy and predictability), and now to the responsible, transparent generative ai. the key emerging trends for language processing and generation include • adoption of deep learning and transfer learning architectures driving accuracy, performance, and speed. • the nlp shifts from extraction of isolated entities to abstractive reasoning and language models. • using models for text critiquing, information retrieval, question answering, summarization, gaming, text generation, and translation. with state-of-the-art pretrained language models (eg, gpt-3, gpt-j, bart, bert) that can be fine-tuned for the biomedical domain, the system can generate human-like summarizations and narratives.10 consequently, the text summarization exercise and the final document generation can be reduced to a few days rather than a few weeks, even after accounting for the final manual review and approval processes. moreover, with all workflows automated, the scope of error is minimized, contrasted with the current manual process (figure 2). to bring about these efficiencies, the ai-led platform for life sciences is envisaged to encompass the following key features: • unified search across multiple internal and external databases • built in deep learning models for article recommendation in the context of pharmaceutical clinical trials, regulatory intelligence, and medical research • state-of-the-art language models fine-tuned for life sciences for text summarization and nlg tasks • real-time data ingestion of structured or unstructured documents from varied data sources (scientific articles from pubmed, regulatory sources like the us food and drug administration (fda), european medicines agency, csrs, and protocol documents, etc) • nlp-based automatic document structure extraction, content enrichment, and sentiment analysis • dynamic document editing features leveraging scientific lexicons and ontologies • workflows for collaborative medical authoring • content citations (ability to refer to original sources from a machine-generated summary) • templatization of the final document based on the need figure 2. automated process of medical writing. ai, artificial intelligence; csr, clinical study report. http://www.amwajournal.org amwajournal.org 49leveraging ai, nlp, and nlg in medical writing medical writing typically involves authoring contents like medical manuscripts, posters, or clinical study reports with predefined templates for each content type. an authoring template is not just a bare-bone skeleton for content authoring but a composite of individual sections, the onboarding of which entails data ingestion, article recommendation, and content summarization steps (figure 3). let us illustrate this through an example of the introduction section of a typical manuscript. this section includes content primarily from pubmed articles contextualized for disease description, epidemiology, burden of disease, and a drug mechanism of action. the following activities are required for the generation of an introduction section of the manuscript. • for data ingestion, pubmed articles are considered, and indexing is configured for relevant article sections like “abstract” and “introduction.” nlp pipelines are used for the classification of sentences as belonging to categories like “description of disease,” “burden of disease,” “disease epidemiology,” and “mechanism of action.” these create labels and do ner for diseases, drugs, molecules, and so on. • for article recommendation, natural language query understanding pipelines for intents like classification contexts are defined. search ranking rules and boosting criteria are refined as required. • for content summarization, based on the section specific summarization or narrative needs, the platform evaluates the available language models. for configuration initial training, samples are curated for platform-suggested language model fine-tuning, and pipelines are defined for subsequent active learning. figure 4 provides a schematic view of the platform architecture. the document sources will not only be external in nature like pubmed, ovid, and clinicaltrials.gov, but also figure 3. section onboarding in medical writing platform. nlp, natural language processing. figure 4. a schematic view of the platform architecture. api, application programming interface; ema, european medicines agency; fda, united states food and drug administration; ml, machine learning; nlp, natural language processing. http://www.amwajournal.org amwajournal.org 50leveraging ai, nlp, and nlg in medical writing regulatory documents like those published by the fda and document sources that are internal to any organization deploying the platform. during the ingestion of the documents, document structure is extracted and tagged with metadata that helps in indexing and classifying the content for future use. such extraction includes classification of sentences and paragraphs and sections as dealing with different drugs, diseases, and other biomedical terms. when a user searches for documents, the questions posed by the user in plain english are translated into machine-readable queries that are then searched against the indexed documents. the results are then ranked according to the rules and boosting criteria used and returned to the user as recommendations. once the user selects the documents identified for summarization, nlg is used to generate extractive or abstractive summaries of the selection. conclusion ai and ml, combined with nlp and nlg, promises to benefit the medical writing process by reducing the manual aspects of the work by automating many steps, in addition to improving quality and reliability. the time and effort thus saved can be substantial to large organizations that often spend a considerable amount of both during the lifecycle of a drug. author declaration and disclosures: the authors acknowledge the team’s learning from building the cognitive search and medical writing platform at infosys. author contact: deepakpn@infosys.com references 1. alexander l, de milto l, kryder c. ultimate guide to becoming a medical writer. amwa. accessed september 2022. https://info. amwa.org/ultimate-guide-to-becoming-a-medical-writer 2. medical writing market size, share & trends analysis report by type (clinical, regulatory), by application (medical journalism, medico marketing), by end use, by region, and segment forecasts, 2022-2030. grand view research. published april 2022. accessed september 2022. https://www.grandviewresearch.com/industryanalysis/medical-writing-market 3. pubmed production statistics. accessed may 2022. https://www. nlm.nih.gov/bsd/medline_pubmed_production_stats.html/ 4. google docs. wikipedia. accessed september 2022. https:// en.wikipedia.org/wiki/google_docs#history 5. cawsey aj, webber bl, jones rb. natural language generation in health care. j am med inform assoc. 1997;4(6):473-482. 6. teo l. report is too long to read? use nlp to create a summary. towards data science. published october 29, 2020. accessed may 2022. https://towardsdatascience.com/report-is-too-long-toread-use-nlp-to-create-a-summary-6f5f7801d355 7. kan my, mckeown kr, klavans jl. applying natural language generation to indicative summarization. arxiv. preprint posted online july 16, 2001. doi:10.48550/arxiv.cs/0107019 8. vaswani a, shazeer n, parmar n, et al. attention is all you need. paper presented at: 31st international conference on neural information processing systems; december 4-9, 2017; long beach, ca. accessed september 2022. doi:10.5555/3295222.3295349 9. wang r, shivanna r, cheng dz, et al. dcn v2: improved deep & cross network and practical lessons for web-scale learning to rank systems. arxiv. preprint posted online october 20, 2020. doi:10.1145/3442381.3450078 10. radford a, narasimhan k, salimans t, sutskever i. improving language understanding by generative pre-training. the university of british columbia. 2018. accessed september 2022. https://www.cs.ubc.ca/~amuham01/ling530/papers/ radford2018improving.pdf 11. parthasarathy discusses implications of large language models. university of michigan. accessed january 2023. https:// fordschool.umich.edu/news/2022/parthasarathy-discussesimplications-large-language-models http://www.amwajournal.org https://info.amwa.org/ultimate-guide-to-becoming-a-medical-writer https://info.amwa.org/ultimate-guide-to-becoming-a-medical-writer https://www.grandviewresearch.com/industry-analysis/medical-writing-market https://www.grandviewresearch.com/industry-analysis/medical-writing-market https://www.nlm.nih.gov/bsd/medline_pubmed_production_stats.html https://www.nlm.nih.gov/bsd/medline_pubmed_production_stats.html https://en.wikipedia.org/wiki/google_docs#history https://towardsdatascience.com/report-is-too-long-to-read-use-nlp-to-create-a-summary-6f5f7801d355 https://towardsdatascience.com/report-is-too-long-to-read-use-nlp-to-create-a-summary-6f5f7801d355 https://doi.org/10.48550/arxiv.cs/0107019 https://dl.acm.org/doi/10.5555/3295222.3295349 https://dl.acm.org/doi/10.5555/3295222.3295349 https://dl.acm.org/doi/10.1145/3442381.3450078 https://www.cs.ubc.ca/~amuham01/ling530/papers/radford2018improving.pdf https://www.cs.ubc.ca/~amuham01/ling530/papers/radford2018improving.pdf https://fordschool.umich.edu/news/2022/parthasarathy-discusses-implications-large-language-models https://fordschool.umich.edu/news/2022/parthasarathy-discusses-implications-large-language-models https://fordschool.umich.edu/news/2022/parthasarathy-discusses-implications-large-language-models v37 n2 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 45 amwa president gail v. flores, phd, called the meeting to order and provided a report about the accomplishments of the organization over the past year. she expressed gratitude to the 2020-2021 board of directors (bod), committee and task force members, and volunteer leaders, who devoted their time and energy to lead amwa during a challenging year. julie phelan, md, mba presented a financial report for the period of july 1, 2020, to june 30, 2021. dr flores announced that in accordance with the amwa bylaws, the nominating committee presented the following slate of officers for 2021-2022 to the amwa bod: • president-elect: elise eller, phd • secretary: michelle sauer-gehring, phd, els • treasurer: julie phelan, md, mba the amwa bod approved the slate, and the membership was notified of this slate 60 days before the annual meeting. the amwa bylaws contain a provision for additional nominations to be made in writing and no additional nominations were received. nominees who are unopposed are elected automatically at the annual business meeting. dr flores declared the slate to be the elected officers for 2021-2022 led by katrina r. burton, who as presidentelect automatically assumes the office of president. dr flores passed the gavel to amwa’s incoming president, katrina r. burton, and ms burton thanked the former for her leadership during continued challenging times. ms burton introduced the 2021-2022 amwa bod and shared highlights from her inaugural address scheduled for publication in the amwa journal. ms burton announced the launch of a new diversity and inclusion task force, the organization’s plans to transition the amwa journal to a digital platform, and the continuance of efforts in place to elevate the value of medical communicators. r. michelle sauer gehring, phd, els / 2020-2021 amwa secretary 2021 annual business meeting for amwa members november 12, 2021, 12:30-1:00 pm est amwa news officers: • immediate past president: gail v. flores, phd • president: katrina r. burton, bs • president-elect: elise eller, phd • secretary: r. michelle sauer gehring, phd, els • treasurer: julie phelan, md, mba • executive director: susan krug, ms, cae at large directors: • joan affleck, mba, els • brian bass, mwc • loretta bohn, ba, els • sarah dobney, mph • elise eller, phd • kim korwek, phd • lynne munno, ma, ms • joanna pendergrass • laura sheppard, mba, ma • shawn watson, pharmd, phd, bcps cac chair: • jennifer minarcik, ms http://www.amwajournal.org 118 amwa journal / v36 n3 / 2021 / amwa.org q what are the pros and cons of using reference management software programs to manage references? what are your preferences in terms of software? a if you don’t relish manually typing references and renumbering citations during manuscript editing, the pros of using reference management software far outweigh the cons. i started using citation management software very early in my medical writing career and i have never looked back. i was a longtime user of the defunct reference manager and then switched to endnote, which is made by the same company. i also learned to use the opensource zotero for one client who eventually switched to endnote. i currently use endnote x8, and i am considering upgrading to the latest version. the few times that i needed tech support, they responded quickly with information to help me resolve the issue. another strong incentive for me to use endnote is that it is the software used by all of my clients who use citation management software. here are some of the pros and cons of using reference management software: pros: • saves times by automating renumbering and reformatting of citations and reference lists • makes it easy to capture citations from major databases, standardize formatting of reference lists, and reformat a manuscript for submission to a different journal • facilitates the management and sharing of citation databases and associated pdfs cons: • cost (except for some free programs like zotero) • learning curve to become proficient with the software • need to sometimes edit literature database entries and journal styles (to resolve issues like capitalization format, number of authors listed) • need to remember to remove codes before to submission to certain journals (an easy automated step) i think that reference management software is an essential, timeand headache-saving tool for medical writers who write scientific articles and other types of manuscripts and reports containing multiple citations. — monica nicosia reference management software platforms include endnote, zotero, reference manager, mendeley, easybib.com, cite this for me, sciwheel, refworks, and cite4me.org. my preference is endnote because i have used it for decades. i update whenever i purchase a new computer (50% discount from company). endnote also has a very knowledgeable tech team to help resolve any issues. because i have multiple clients, i do not use endnote online because it may merge the endnote files from multiple clients. however, if you are at a university, it may not be an issue. i experience the following main advantages to using endnote during the literature search, the main writing process, formatting, and providing deliverables: 1. harvesting potentially relevant references during the supplemental literature search 2. single-click retrieval of most open-access journal articles 3. downloadable citations from pubmed and other databases 4. searchable database with relevant references while writing 5. time saver for formatting in-text citations and an accurate reference list during writing and subsequently after clientrequested revisions 6. relatively rapid conversion to other formats for citations in the text and reference list 7. editable format styles so i can make client-specific styles 8. easily transferable file (eg, endnote) to clients in case client may have further rounds of reviews (eg, guidelines for professional societies) the advantages of reference management software increase with the length of the document and the number of citations. many clients prefer the use of reference management software and also prefer further details on the location of the specific information cited in the reference. depending freelance focus brian bass allie boman katherine molnar-kimber monica nicosia amwa journal / v36 n3 / 2021 / amwa.org 119 freelance focus on the client’s preferred style, i often provide the added information (eg, page, paragraph, table, figure) in a comment bubble. as for contraindications, when a client prefers that the in-text citation uses their in-house specific format style that contains the page and paragraph, the reference management software may consider each entry as a new reference. in summary, i routinely use reference management software while writing documents. if needed, the endnote metatag can be removed before sending deliverable. — katherine molnar-kimber q is there a particular software that you would recommend to keep track of business expenses for tax purposes? a i am quite happy with freshbooks, which i started using 5 years ago when i relaunched my freelance business. freshbooks is easy to use, and the tech support is good. i access my secure, cloud-based freshbooks account from a web browser and from an app on my phone. a user-friendly interface allows me to easily enter my expenses (manually or by importing credit card or bank charges), add pictures of receipts to expenses, and generate income/expense reports for preparing taxes. like other similar programs, freshbooks provides the option of sharing data and reports with an accountant. there are many types of accounting/bookkeeping software platforms and apps that can be used to keep track of business expenses. some are available for free, usually with limited functionality. other examples of accounting/bookkeeping software and apps include accountedge, expensify, freeagent, paydirt, quickbooks, quicken, wave, xero, and zoho. i have not used them or read recent reviews about them so i can’t recommend any particular one. in my unpublished 2018 freelance medical communicator tools of the trade survey, the top 4 accounting/bookkeeping software/apps used by participants were quickbooks online (11%), quickbooks desktop (8%), quicken home & business (5%), and freshbooks (2%). i chose freshbooks because i wanted an affordable app that integrates functions that i consider essential for my business: accounting/bookkeeping (to track payments and expenses for invoicing and tax purposes), time tracking (to easily record the time spent on various projects/tasks), and invoicing. i now also use it to generate project estimates. these integrated functions save me time and thus money. — monica nicosia business software may be the most hotly contested tool in the freelancer’s toolbox. perhaps that’s because it’s one of the few pieces of software we get to choose for ourselves. some freelancers, including myself, love the business software they use and would never switch. some dislike the business software they use but continue using it anyway. perhaps due to fear of the unknown? in my opinion, there are only 2 mistakes a freelancer can make when it comes to business software: 1. using a software program not designed specifically for small businesses 2. not using all the features of your business software i started using software for bookkeeping very early on, when there weren’t any programs designed specifically for small businesses. i used quicken, which at the time i was using for my personal finances. when quickbooks was introduced, my freelance business switched over to it and i never looked back. quickbooks is great for tracking and reporting business expenses. it remembers vendors and how i’ve categorized them for tax reporting purposes. that makes my accountant’s job easier, which saves me money. quickbooks tracks invoices to make sure i pay them on time, which i do simply by clicking “pay” and then “print” to print a record. i pay as many bills as possible electronically, which is easier and faster for me and better for everyone i pay. quickbooks tracks the payments i make to freelancers on my team so i can generate a 1099 report with a single click at the end of the year. quickbooks also tracks my payroll-related 941 tax payments to the electronic federal tax payment system. with a click i generate a subreport of those payments itemized for medicare, social security, and tax withholding. that also makes my accountant’s job easier. it takes less than 5 minutes to prepare the quarterly tax report for my accountant, which i email to him directly through quickbooks. at the end of the year, it takes about 10 minutes to prepare the complete year-end report for my company’s final tax filing. — brian bass my simple answer is that i’ve found quicken to be easy to use, reliable, and relatively affordable. before i elaborate on quicken, i’ll give a brief overview of situations in which quickbooks would be my recommendation. i used quickbooks nonprofit for 15 years as a bookkeeper. we needed this more robust software for sending tax receipts to our donors and for tracking multiple users’ activities. consider quickbooks (rather than a personal finance software like quicken) if you: https://www.nicosiamedicalwriter.com/portfolio 120 amwa journal / v36 n3 / 2021 / amwa.org • need to write invoices and receipts (i use the time tracker harvest for this) • have multiple people using the same business bank account • have regular employees or subcontractors when i transitioned from nonprofit work to freelancing, the minimum payment of $25/month seemed exorbitant. quicken (i pay $3/month) does the following for me: • automatically enters transactions from my bank accounts • categorizes my income and expenses • handles my business and personal accounts side-by-side • streamlines reporting for taxes • makes it easy to observe trends in my business and analyze development efforts (reports are very user friendly) i started with my tax lady’s worksheet when setting up my categories; each line item she requests becomes a category. this ensures that i can write off as many business expenses as possible. i also track some categories for my family, such as eating out (way down this fiscal year!). a few more things to consider: • make sure the software will sync with your specific bank. • i have not found the budgeting features very intuitive in either quicken or quickbooks. • it takes me about 15 minutes per month to review the transactions uploaded in quicken and make sure everything has been categorized properly. • at tax time, it takes no more than 45 minutes to report everything accurately. my tax lady gives me a discount for turning in my information early. this discount more than pays for the annual price of quicken! — allie boman freelance focus international society of managing and technical editors october 11-14, 2021 virtual https://www.ismte.org/page/conferences regulatory affairs professionals society september 12-15, 2021 virtual https://www.raps.org/regulatory-convergence national association of science writers october 8-11, 2021 boulder, colorado, and virtual https://www.nasw.org/events international conference on communication in healthcare october 17-20, 2021 virtual https://achonline.org/icch2021 american public health association october 24-27, 2021 denver, colorado, and virtual https://www.apha.org/events-and-meetings/annual amwa medical writing & communication conference october 27-29, 2021 virtual www.amwa.org/conference european medical writers association november 4-6, 2021 london, england, and virtual https://www.emwa.org/conferences/future-conferences/ alliance for continuing education in the health professions january 12-15, 2022 aurora, colorado http://www.acehp.org/p/cm/ld/fid=570 american association for the advancement of science february 17-20, 2022 philadelphia, pennsylvania, and virtual https://meetings.aaas.org/ dia europe 2022 march 29-31, 2022 brussels, belgium, and virtual https://www.diaglobal.org/en/flagship/dia-europe-2022 calendar of meetings please confirm with individual meeting hosts www.amwa.org/conference 2021 amwa medical writing & communication conference october 27-29, 2021 coming to a device near you trends and opportunities for medical communicators http://www.amwa.org/conference https://www.ismte.org/page/conferences https://www.raps.org/regulatory-convergence https://www.nasw.org/events https://achonline.org/icch2021 https://www.apha.org/events-and-meetings/annual http://www.amwa.org/conference https://www.emwa.org/conferences/future-conferences/ http://www.acehp.org/p/cm/ld/fid=570 https://meetings.aaas.org/ https://www.diaglobal.org/en/flagship/dia-europe-2022 82 amwa journal / v36 n2 / 2021 / amwa.org q what are the pros and cons of different types of medical writing (ie, pharmaceutical/biotech, regulatory, managed-care industry, the publishing industry, public relations, lay press, public health, nonprofits, and hospital/university)? a my 20 years as a full-time writer/editor at a research facility attached to a hospital included the preparation of texts for journal publication, talks for meetings, editing of books, and management of 13 annual reports. this wide range of experiences led to not only subsequent employment at a pharmaceutical company but also access to contacts as a freelancer for clients in 6 countries. obvious advantages of the full-time situation, of course, are steady salary, benefits (insurance, etc.), and retirement plan, all based on that of a university medical school. less obvious is the personal growth in skills and opportunities, for example, company-paid membership in the american medical writers association (amwa)! the only real disadvantage was time constraints, such as limits on vacation time. afterward, when a new director of the institution replaced me and much of the former staff, my subsequent job was as freelance writer for a commercial pharmaceutical company. advantageously, the hourly pay was about 1½ times higher than before. sometimes i could work from home, and because the company freelancers were a team, i could choose amounts of time off. the disadvantage that surprised me was resentment from my full-time colleagues that i could come and go at will. finally, i became a roving freelancer. i am still amazed that post docs from early in my full-time research-institution career had advanced to become department heads, particularly in china and japan, and requested editorial services at my choice of cost/hour. however, that situation included the disadvantage of a lag in time of payment, sometimes weeks or months after completion of a project, because the clients preferred to lump costs together. this saga would not be complete without citing the advantageous gift of amwa membership, which provided professional contacts and teaching opportunities that did and still do underlie my career. — phyllis minick although i have worked for all of the above industries, i will focus here on the area of my most extensive experience: pharmaceutical/biotech companies. all of these companies need medical communication professionals. many people think that the industry is all about regulatory affairs; it is not. regulatory affairs work is its own thing, often quite apart from other areas of the industry. for example, departments aside from regulatory affairs that generate work for writers and editors in a pharma/biotech company may include the following • advertising • animal sciences • biological sciences • clinical research • corporate communication (public relations) • corporate or product development • human resources • marketing communication • medical affairs/medical services • medical communication • pharmacology • professional training and education (for non-md health care professionals) • sales training and communication • website management thus, one could say that medical communication in pharma/biotech includes virtually every aspect of communication, a wide variety of target audiences, and all media. as an employee and later a freelancer, i have worked for all of these departments. for years, i contracted directly with the companies, but today, most companies (the larger ones, at least) prefer to hire outside agencies to handle their writing/editing/ communication needs. for regulatory affairs and clinical research projects and reports, a contract research organization is used; for most other communication projects, agencies for medcom, continuing medical education, advertising, or sales training are hired. as a freelancer, some advantages of contracting directly with a company include more intimate contact with the players; the ability to call an expert in the company any time you need to, generally a higher rate, and a feeling of being freelance focus brian bass lori de milto phyllis minick amwa journal / v36 n2 / 2021 / amwa.org 83 more immediately connected with the entire process, whether it be medical affairs, marketing, or regulatory affairs. when contracting with an outside agency, you are one step removed; you generally are paid a bit less because one must consider the agency’s need for profit/markup, and you sometimes get paid late (some agencies even ask the freelancer to wait until they have been paid before paying the freelancer). moreover, depending on the agency, they may be rather paranoid about allowing you to speak directly with the pharma/biotech client, ie, worried that the company might want to hire you directly. so, usually you must sign a “noncompete” agreement in addition to the nondisclosure agreement, and sometimes negotiations over the reasonableness of such contracts can become complicated. regardless of whether you contract with a pharma/biotech company directly or through one of their agencies, there are many advantages to working in this industry, a few of which include • a chance to work on a wide range of projects and/or therapeutic areas • a plethora of work because of the vast number of such companies and agencies • the opportunity to work with intelligent people and teams • the joy of being able to work on projects that are genuinely interesting and fun (usually when working in medcom, marketing, sales training) • interesting travel opportunities paid by the company • helpful education and training • generally a higher hourly rate than paid by other industries there are, of course, also some disadvantages as well. below are some that are mostly related to regulatory affairs (although some of these can been seen as advantages if you enjoy studying and learning): • you must study and understand well the industry as a whole, including the process of proving new drugs, devices, or biologicals. • you need to be comfortably familiar with food and drug administration regulations and guidelines in general as well as those relating to the production of specific types of reports and clinical summaries. • you should understand thoroughly the structure and contents of an nda submission (ie, the common technical document), even if you are writing only a specific segment or section of such submission. • you may end up with a team (in-house or in-agency) filled with tension and fear because their bonuses and raises depend on achieving milestones and deadlines demanding enough to increase your stress level, to say nothing of the horrendous stress level of the associates with whom you end up working. (in this regard, the agencies do have more burden, because they contract with the companies for extremely high dollars and are liable for errors and omissions for which a freelance writer in pharma/biotech should never accept liability.) • you could be working with an inept project manager and thus find yourself receiving a “data dump” that takes hours to dissect and organize, leading to “scope creep” that requires you to fill the role of project manager, which function should pay more; thus, you may have to renegotiate your fees (i charge ≥30% more for project management and organization than for writing.) • you could find yourself in the uncomfortable position of having to tell the company or agency employees that their “ask” would violate ethics as well as regulations. this could be about a particular “spin” the client wants you to create from clinical study results (eg, in a clinical study report or a journal article), claims a marketing group wishes to make in collateral materials for sales representatives and/or health care professionals, hiding or omitting data that are unflattering to the company, and other questionable practices. overall, the pluses outweigh the minuses; otherwise, i might have dedicated most of my career to working for nonprofits. — cathryn d. evans all types of medical writing have pros and cons. although you should choose the type of medical writing you do, your background, experience, and writing skill are usually more important than your preferences. for example, regulatory writing pays more than other types of medical writing and is in high demand. but with my journalism degrees and my freelance experience in health care content marketing and health journalism, i’m not qualified to do regulatory writing. likewise, many freelancers with clinical or scientific degrees and experience wouldn’t do well at what’s usually considered the more glamorous side of medical writing: public relations, content marketing, most work for patients and the public, and marketing-oriented work for health care professionals. you need very strong writing skills for this type of work. if you work with the right clients like i do, the pay for this type of work is very good but not usually as high as most other types of medical writing. the deadlines are usually much more reasonable than in other types of medical writing, and there are very few meetings or team-based work, which i like. there’s a lot more freelance work in what i call clinical and scientific medical writing (pharmaceutical/biotech, regulatory, etc.) than the type of work i do. that’s good news because most medical writers have clinical or scientific backgrounds. learn more about different types of medical writing before deciding what might be right for you. talk to other freelancers freelance focus 84 amwa journal / v36 n2 / 2021 / amwa.org about what they like and don’t like about their work. look for courses, tutorials, and other opportunities to try types of medical writing that seem interesting to you. — lori de milto q have you offered daily rates to your clients? if so, what are the situations in which daily rates have worked best for you? a i have never offered daily rates to my clients and would never do this. as freelancers, we need to have time for the inevitable revisions that come in when we aren’t expecting them and rush projects for good clients. if we agree to spend a full day doing work for one client, then we either can’t serve our other clients or we have to work too much to be productive. also, under the internal revenue service standard for independent contractors, “the payer has the right to control or direct only the result of the work, not what will be done and how it will be done.” a daily rate could violate this standard. it is also very likely to be a problem in any legislation that might be passed, such as the pro act. in my freelance business, most days, i do work for 2 or 3 clients. although i occasionally spend all or most of one day or a few days on work for one client, i would never commit myself to doing this by offering a daily rate. a project rate is a much better way to bill clients. it gives clients the cost of the job for budgeting purposes and gives us the flexibility to do the job when it works best for us as long as we meet the deadline. — lori de milto i have offered daily rates for projects requiring travel, eg, my hourly rate times 8.0 hours per day, including flying/travel time, regardless of how many hours are actually “worked” that day. if the client wants more than 8-10 hours of work in a single day, i charge my hourly rate for the hours above that. (i do not charge the time for going out to dinner with the group, unless it is a working dinner.) otherwise, for most projects i simply charge hourly, although for some clients i will produce something for a fixed fee. — cathryn d. evans i don’t think it’s good idea to offer clients daily rates because it ties your value to your time, and there’s a finite amount of money any client will pay for an hour of your time. worse yet, the thinking behind a daily rate is that the client’s giving you a full day of work, so your day rate should be discounted from your accumulated hourly rate for a day of work. first of all, the client isn’t doing you any favors because tying you up for a day keeps you from being able to juggle the other clients and assignments you have. second, suggesting you give a client a break for a full day of work implies you don’t otherwise have a full day of work on your plate, because if you did, you’d make more money doing that work instead. whether you really have a full day of work on your plate or not, your client should believe you do and pay you accordingly. that said, i do use a “daily rate” in my estimates for attending in-person advisory board meetings. remember when they used to be a thing? my “daily rate” in those circumstances is actually a bit higher than what the client might pay as a cumulative hourly rate. they’re taking me away from juggling everything else on my plate, and sometimes, those days can be pretty long. the client is paying for my undivided attention, whether i’m actually in the meeting or traveling across the country to get to the meeting and get home. this also helps ensure that clients only take me out of the office when they really need me. — brian bass freelance focus general principles of word usage www.amwa.org/online_learning choose the right word for accuracy and clarity. amwa journal / v36 n2 / 2021 / amwa.org 85 “.death is the easiest note to write,” they told me. it’s the same for every patient. they have no pulse, no spontaneous movement. no breath sounds auscultated. no sign of life. but the phone call, that’s the hardest part. how? when? why? was it painful? am i allowed to say i’m sorry? because i really am sorry. i’m sorry you dropped your dad off, and didn’t know it was goodbye. do we really do no harm? blood sticks and drips, central lines hurt. but maybe dying alone is easier, they don’t see you at the unimaginable end. they don’t see your heart kill your kidney, gram-negative rods infect your blood. but i see you. i watch your labs and check your chart. i dread actually looking at you suffer. i turn my eyes away from your agonal breath, but i sit a little longer and hold your hand. hoping if i stay for a few more minutes, you won’t have to do it alone. .death—will it ever get easier? will i ever not feel my throat tighten and tears come when i talk to your family? but maybe i want the doctor to cry, instead of typing .death without adding a single word. *“.death” is an expandable dot phrase. dot phrases are used in electronic medical records for a frequently used note or phrase. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: morgan.katz@jefferson.edu creative writings morgan katz, do / resident physician, abington–jefferson health .death* mailto:morgan.katz@jefferson.edu v37 n1 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 16 best practices for medical writing with a disclosure mindset speaker thomas wicks, mba, chief strategy officer, trialscope/ informa, jersey city, ny by nisreen shumayrikh, phd clinical trials are conducted almost everywhere worldwide, and trial disclosure requirements continue to expand, with an average of 2 new trial registries going live every year. this global expansion can lead to inconsistent public disclosure of study protocols, trial results, and associated documents. the inconsistency becomes apparent when the information is disclosed through various registries, company trial websites, and publications and then assessed by recruiters, industry and financial analysts, and patient advocacy groups. regulators in various countries have started to include disclosure compliance in their inspection regime, whereas industry critics and transparency advocates continue their detailed assessments of transparency practices. beyond these regulatory inspections and assessments, sponsors face additional risks if the disclosure decisions are not well harmonized. in his presentation at amwa’s 2021 conference, thomas wicks, chief strategy officer at trialscope/informa, suggested best practices to regulatory medical writers for authoring source documents such as protocols and clinical study reports (csrs) with disclosure requirements in mind. efficient disclosure to support disclosure, mr wicks suggested creating a protocol “disclosure template” that includes the main registration data, including the trial identification number, public and scientific titles, brief description, eligibility criteria, and others. a good starting point is adopting the registration data set developed by the world health organization and providing the protocol registration information from clinicaltrials.gov or eudract (if available) to local affiliates, partners, and contract research organizations (cros) to use as their source data for registration to local registries. mr wicks then discussed some disclosure considerations regarding study endpoints. these include • alignment: explain clearly how each endpoint aligns with objectives, • measure: document how each endpoint will be measured, • scales: explain scales and indicate the best and worst scores, • objective: include measurement objective, • classification: classify endpoints and structure them (eg, primary, exploratory, secondary), • templates: ensure that objective has one or more endpoints, • definitions: define study process (eg, study dates, enrollment), and • summaries: summarize all nonserious adverse events in a test. “each study objective has to be backed up with an endpoint,” mr wicks said. incorporating plain language when preparing source documents such as the clinical trial protocol or csr, consider the information needs of patients and potential trial participants. the information relevant to patients and participants should be written in plain language as part of the protocol, including • the study title and a brief description, • the description of the health condition, • the product description, • the key inclusion/exclusion criteria, • description of study procedures/assessments, • primary and, possibly, key secondary outcome measures, • additional context around age range and sex of the participants, and • length of participation. the advantage is that submitting these plain language elements to trial registries improves patient communication and benefits users like recruiters and patient advocates. regarding the source documents, mr wicks emphasized integrating plain language elements in the protocol, csr, and even the informed consent form, which is often not session reports conference http://www.amwajournal.org http://clinicaltrials.gov https://eudract.ema.europa.eu/ amwajournal.org 17session reports a clear as could it be. additionally, he suggested adding a plain language abstract to the study synopsis, especially when the sponsor does not plan to provide a separate plain language summary. other handy tools include developing a plain language glossary and templates. prepare for redaction and anonymization for participant information, avoid the following: • using pronouns in patient narratives; consider using “the patient” instead, • using “verbatims” with quotes by the investigator, as these may include unique circumstances that could describe a patient, or • including patient ids in images of tables. if patient ids are required, then either include tables with selectable text (instead of copied as an image) or keep table formatting consistent across all images to ease redaction. for study or sponsor staff information and other identifiers, avoid the following: • adding names of the study staff with their organizational titles; instead, use only their study role, • including contact information such as fax, phone, or email, • incorporating cvs or certificates or adding them to an appendix, • adding personal identifiers to bookmarks (such as patient ids, names, study admin), or • providing treatment allocation and group information throughout the document. other final considerations: • limit duplication that requires duplicate redactions, for example, providing a table with patient narrative information followed by text with some of the same information. • in the sample case study report case report form (crf), use a clearly fake patient id like xxxx or 0000 (not even “1234”). • aim to keep page numbering consistent between the csr and the pdf copy to help remove out-of-scope information. • because foreign language pages are out of scope, you may keep these in an appendix or remove them. these are some best practices for medical writing with a disclosure mindset. it is part of your job as a regulatory medical writer to have a basic knowledge of disclosure regulations and support trial transparency. nisreen shumayrikh is a medical writer and scientific communicator at guanine medical in vancouver, bc, canada author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: nisreen@guaninemedical.com * * * bridging the gap: transitioning into regulatory medical writing speakers amber carr, phd, medical writer, merck, rahway, nj savannah mageau, pharmd, medical writer, merck, rahway, nj shengjie xu, phd, medical writer, merck, rahway, nj by stephany panlilio, ms the role of a medical writer is everchanging and requires a range of technical knowledge and soft skills to create cohesive documents in preparation for submission to regulatory health authorities. medical writers come from a variety of different backgrounds with varying levels of experience. for those looking to enter the field, there are a number of transferable skills from previous experiences, training opportunities, and techniques to bridge knowledge gaps in preparation for transitioning into a regulatory medical writing role. this article summarizes the experiences of dr carr, dr mageau, and dr xu as they each transitioned into regulatory medical writing. skills leveraged from previous experiences in their presentation, dr carr, dr mageau, and dr xu shared their previous roles in experimental research, pharmacy practice, computational research, and teaching and medical communication and the skills they gained from each that were transferable to their role as medical writers. the skills they found most applicable to medical writing are summarized into the following 3 categories: soft skills, technical skills, and core knowledge. soft skills the soft skills of self-management and project management that dr xu gained from her time in experimental research have helped in her medical writing role. managing time, setting priorities, and working independently are critical as a medical writer, and developing these skills can increase productivity. medical writers must be able to manage multiple project timelines and have the flexibility to adjust when something unexpected arises (eg, shifting research http://www.amwajournal.org 58 amwa journal / v36 n2 / 2021 / amwa.org introduction maintenance of quality in publications during public health emergencies timely release of data in the form of peer-reviewed publications is crucial in medical research and necessary for productive scientific discourse. however, during public health crises such as a pandemic, the need to communicate science rapidly can lead to abbreviated vetting and substantially increase the risk of compromised quality and accuracy in data analysis and reporting. indeed, the pressing requirement for speed in tackling a pandemic and the necessary collaboration between academia, industry, and regulatory agencies on an international level creates a significant dilemma: the need to rapidly release data on pubmed central and other resources, such as the world health organization’s databases, while upholding the quality of the communication and the data. maintenance of integrity and accuracy in scientific publications via a thorough vetting process prior to public release requires time and implementation of quality-control measures. medical communicators have an important role to play in this process. by way of their speed, some publication modalities, such as preprints, may seem particularly attractive when quick release of information and rapid scientific discourse is desired. however, because such preliminary scientific reports are generally not subject to thorough peer review, there is an inevitable increase in the concomitant risk of lower quality and lack of precision. thus, full disclosure of whether a publication has been peer-reviewed and transparency about the quality-control process are absolutely required. in this joint position statement (jps) from amwa, emwa, and ismpp, we provide suggestions and a structured framework, including a number of practical recommendations that can be implemented to help maintain quality and avoid damaging public trust in scientific and medical communication. the practical recommendations in the current jps are intended to support quality-control processes in both the acute phase of intense reactions during the course of a public health emergency as well as the longer-term evergreen need to maintain quality in medical publications. the persistent call for rapid sharing of scientific advances against a firm background of insistence on high quality enables acceleration of medical innovation. safeguards are presented as a clear and concise checklist that can be used by journals, authors, and medical communicators in the preparation and review of manuscripts before submission. – dikran toroser, phd, cmpp / director, publications group lead, rare diseases, neuroscience, takeda publications, cambridge, ma – gail v. flores, phd / principal writer, encore biomedical communications llc, encinitas, ca amwa representatives to the authorship team for the amwa-emwaismpp joint position statement on medical publications, preprints, and peer review. author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. this joint position statement originally appeared in current medical research and opinion, doi: 10.1080/03007995.2021.1900365. amwa-emwa-ismpp joint position statement on medical publications, preprints, and peer review 1. background in medical publications, just as in research and development, quality depends on the expertise and integrity of researchers/ authors as well as qualified peer reviewers and journal editors. however, the laborious and time-consuming process of the traditional peer review1 can be compromised by the pressure to publish quickly—particularly during a health crisis, when timely distribution of credible medical information can make a substantial difference.2 recent examples of negative consequences are two articles on covid-19 that were hastily published in high-profile medical journals and subsequently retracted.3,4 traditional peer review, although not perfect, remains the most frequently used process for vetting scientific publications. however, it has become more common for manuscripts to be released without prior review, which raises new concerns. the potential value of rapid publication should be weighed against the potential harm of inadequate validation of the final output. there is a danger that lowering the threshold of publication oversight sets a precedent that cannot be easily reversed, potentially eroding standards and public trust in medical science.2 we have joined in a multi-party consortium among three eminent professional organizations for medical communication professionals—amwa, emwa, and ismpp—to advocate for the adoption of standards by all stakeholders to better ensure the integrity of published scientific and medical information. thus, the following joint position statement has been 2021-17-02 amwa-emwa-ismpp joint position statement on medical publications, preprints, and peer review 1. background in medical publications, just as in research and development, quality depends on the expertise and integrity of researchers/authors as well as qualified peer reviewers and journal editors. however, the laborious and time-consuming process of the traditional peer review1 can be compromised by the pressure to publish quickly—particularly during a health crisis, when timely distribution of credible medical information can make a substantial difference.2 recent examples of negative consequences are two articles on covid-19 that were hastily published in high-profile medical journals and subsequently retracted.3,4 traditional peer review, although not perfect, remains the most frequently used process for vetting scientific publications. however, it has become more common for manuscripts to be released without prior review, which raises new concerns. the potential value of rapid publication should be weighed against the potential harm of inadequate validation of the final output. there is a danger that lowering the threshold of publication oversight sets a precedent that cannot be easily reversed, potentially eroding standards and public trust in medical science.2 we have joined in a multi-party consortium among three eminent professional organizations for medical communication professionals – amwa, emwa, and ismpp – to advocate for the adoption of standards by all stakeholders to better ensure the integrity of published scientific and medical information. thus, the following joint position statement has been developed to provide practical and implementable suggestions to uphold data integrity and quality, and the transparency of medical publications. note: we use the term “medical writer” to represent the spectrum of professionals who prepare documents either for submission to regulatory authorities or for publication in peer-reviewed journals.5 2. communication of research: issues and suggested solutions 2.1. preprints preprints are preliminary scientific reports that are made publicly available online for anyone to read, comment on, and discuss before they have been peer reviewed. some preprint servers scrutinize submissions for scope and for basic quality standards before making them publicly available.6,7,8 once the preprint is posted, most reputable preprint servers assign a unique digital object identifier (doi) to aid traceability. authors can revise preprints according to readers’ comments and post iterative versions. preprints are often not indexed on mainstream bibliographic services, although europe pmc now indexes preprints,9 and there are standalone tools for searching named preprint servers to improve discoverability.10 f e a t u r e 2021-17-02 amwa-emwa-ismpp joint position statement on medical publications, preprints, and peer review 1. background in medical publications, just as in research and development, quality depends on the expertise and integrity of researchers/authors as well as qualified peer reviewers and journal editors. however, the laborious and time-consuming process of the traditional peer review1 can be compromised by the pressure to publish quickly—particularly during a health crisis, when timely distribution of credible medical information can make a substantial difference.2 recent examples of negative consequences are two articles on covid-19 that were hastily published in high-profile medical journals and subsequently retracted.3,4 traditional peer review, although not perfect, remains the most frequently used process for vetting scientific publications. however, it has become more common for manuscripts to be released without prior review, which raises new concerns. the potential value of rapid publication should be weighed against the potential harm of inadequate validation of the final output. there is a danger that lowering the threshold of publication oversight sets a precedent that cannot be easily reversed, potentially eroding standards and public trust in medical science.2 we have joined in a multi-party consortium among three eminent professional organizations for medical communication professionals – amwa, emwa, and ismpp – to advocate for the adoption of standards by all stakeholders to better ensure the integrity of published scientific and medical information. thus, the following joint position statement has been developed to provide practical and implementable suggestions to uphold data integrity and quality, and the transparency of medical publications. note: we use the term “medical writer” to represent the spectrum of professionals who prepare documents either for submission to regulatory authorities or for publication in peer-reviewed journals.5 2. communication of research: issues and suggested solutions 2.1. preprints preprints are preliminary scientific reports that are made publicly available online for anyone to read, comment on, and discuss before they have been peer reviewed. some preprint servers scrutinize submissions for scope and for basic quality standards before making them publicly available.6,7,8 once the preprint is posted, most reputable preprint servers assign a unique digital object identifier (doi) to aid traceability. authors can revise preprints according to readers’ comments and post iterative versions. preprints are often not indexed on mainstream bibliographic services, although europe pmc now indexes preprints,9 and there are standalone tools for searching named preprint servers to improve discoverability.10 amwa journal / v36 n2 / 2021 / amwa.org 59 developed to provide practical and implementable suggestions to uphold data integrity and quality, and the transparency of medical publications. note: we use the term “medical writer” to represent the spectrum of professionals who prepare documents either for submission to regulatory authorities or for publication in peerreviewed journals.5 2. communication of research: issues and suggested solutions 2.1. preprints preprints are preliminary scientific reports that are made publicly available online for anyone to read, comment on, and discuss before they have been peer reviewed. some preprint servers scrutinize submissions for scope and for basic quality standards before making them publicly available.6-8 once the preprint is posted, most reputable preprint servers assign a unique digital object identifier (doi) to aid traceability. authors can revise preprints according to readers’ comments and post iterative versions. preprints are often not indexed on mainstream bibliographic services, although europe pmc now indexes preprints,9 and there are standalone tools for searching named preprint servers to improve discoverability.10 preprints have been rapidly adopted by physicians and scientists, their obvious benefits being the immediate availability to their peers and the public, avoiding lengthy peer-review processes prior to release, and the option of readers to leave comments. however, there are issues associated with preprints that ideally should be addressed by standards jointly developed by a convened body of all stakeholders. issues with preprints: • while preprints enable rapid release and discussion of data, many are never revised, and only about a third to a half are ever fully published.11,12 • “once the toothpaste is out of the tube, it cannot (easily) be stuffed back in.”13 provocative or poor quality research results could be reported by the media, or posted and discussed on social media, with little regard to the preliminary nature of the findings.14,15 no amount of retrospective “tagging” will have much effect. misinformation or deliberately misleading or sloppy science can be freely circulated, cited, and believed ad infinitum, regardless of whether it is ultimately debunked and retracted. our suggested solutions: • preprints should not be used as references in any medical publication unless these are cited in the manner of a personal communication, that is, as an in-text reference (using the preprint link, doi, or both) rather than as bibliographic references. it should be clearly disclosed that the source is a preprint. • clearly distinguishing preprints from peer-reviewed articles might help to reduce the tendency of readers to view the work as fully vetted.14,15 this should be done by ° watermarking the article, as is done, for example, by medrxiv and biorxiv, with the information that it has not been peer reviewed. ° placing a clearly-worded disclosure in the body of the article highlighting that the findings have not been formally peer reviewed. • pre-publication vetting: ° pre-publication checks by server hosts. medrxiv performs a basic screening process for plagiarism, nonscientific content, and material that might pose a health risk, including material that might compromise existing public health measures.7 however, these checks should be more extensive and consistent across server hosts, and a comprehensive checklist should be used (appendix i). ° encouraging authors to ensure that preprints that have been subsequently fully published be marked as such on the preprint server and linked via doi to the fully published article. 2.2. post-publication peer review in post-publication peer review, an article is published in its original form, then subjected to informal (as with preprints) as well as invited peer review. for instance, with the model used by the f1000 publishing platform,16 articles are posted online after passing pre-publication checks and after an article processing charge (apc) is paid. when posted, articles are assigned a doi and opened to comments from registered users. expert peer reviewers are invited to review in the usual way. all comments, peer review reports, and article revisions are available with the article, and once the article receives two favorable peer review reports, the final, peer-reviewed version is indexed in external bibliographic databases and becomes fully discoverable. the benefits of this model are similar to those of preprints – rapid access for readers and the option for readers to comment. issues with post-publication peer review: • the issues with post-publication peer review are basically identical to those of preprints, but it should be noted that the requirement for an apc would potentially discourage casual or low-quality submissions. articles are clearly marked as “under peer review,” and the progress of that review is accessible to readers. 60 amwa journal / v36 n2 / 2021 / amwa.org • as with preprints, articles undergoing post-publication peer review should not be used as references in any medical publication until the peer review process is completed and the article is approved for publication. if the article is cited, we suggest the citation be made in the same manner suggested for preprints. • issues associated with traditional peer review also apply and are addressed in section 2.3, below. our suggested solutions: • our suggested solutions include those proposed for preprints; however, we suggest that the publication be indexed by mainstream bibliographic databases (if applicable) once it has been fully peer reviewed, as is done on the f1000 platform. 2.3. traditional peer review traditional peer review occurs after a submitted article is accepted for consideration by a journal, then passed to expert peer reviewers. the reviewers’ comments are sent to the authors to use in revising their article, or else the article is rejected after review. for rejected articles, authors can start the process again with another journal. if an article is revised to the peer reviewers’ satisfaction, the article is published and assigned a doi, after which the article is indexed in mainstream bibliographic databases. peer review reports and revisions may or may not be available with the final article, depending on the peer review model the journal uses. the benefit of traditional peer review is that information is released to the readers only after there has been quality control applied by subject matter experts. issues with traditional peer review • lengthy review process, which may impede the timely release of valuable information – particularly in a pandemic or public health crisis • inadequate time for high-quality peer review • inconsistency among reviewers • difficulty in “recruiting” qualified reviewers, given time commitment, particularly in times of health crises when the most appropriate reviewers are likely to have a high clinical workload our suggested solutions: • authors: ° submit rejection comments to second-choice journals, with itemized rebuttals and updates to the manuscript (portable peer review).17,18 ° be more accepting of editor referrals to cascade journals.19 • journal editors: ° accept, request, or require portable peer review as described above, thereby reducing the need for additional review cycles. ° consider commercial back-end services that expedite peer review (eg, researchsquare [https://www. researchsquare.com/], as used by the bmc journals and others). ° form a rapid response team of reviewers, with appropriate expertise, who can provide peer review with a quick turnaround time. • publishers: ° standardize formatting requirements to expedite resubmission.20 ° offer fast-track options for potentially practice-changing work. ° consider incentives for reviewers.21 3. suggested solutions for all formats 3.1. quality control • make use of existing publication guidelines22–24 and available checklists25 to ensure high-quality publication development. • include clinical trial protocols and statistical analysis plans (saps) as supplementary material. • ask all authors to sign an author form confirming that they had full access to the relevant data reported in their article, and accept responsibility for submitting the article for publication. furthermore, the contributor statement should name the authors (at least 2) who have accessed and verified the underlying data, as suggested in the revised lancet publication guidelines.26 • journals should clearly explain the initial quality review that editors perform on newly submitted manuscripts. 3.2. training in peer review • authors, peer reviewers, and editors should be adequately trained in the nature and technical aspects of peer review. • guidelines should be used, such as those created by the committee on publication ethics (cope),25 along with the reviewers’ checklist in appendix i. • medical journalists and the public should be educated on how preprints and pre-publications differ from peerreviewed literature. 4. the role of professional medical writers and scientific communicators in expediting the publication process • evidence suggests that the use of professional medical writers enhances publication quality and speed,27–33 and such assistance has been associated with a reduced risk for retractions due to misconduct.34 if a qualified medical writer is https://www.researchsquare.com/ https://www.researchsquare.com/] amwa journal / v36 n2 / 2021 / amwa.org 61 part of the team, they should be involved in the process as early as possible.5 the medical writer should have access to the clinical study report (if available), source data, and related documents, including statistical outputs and patient narratives, to the extent that data-protection regulations allow. • professional medical writers should have an active role in ensuring the high quality of publications, including their development, editing, and referencing,22,24,35 and the use of appropriate publication checklists.36 medical writers and statisticians should be actively involved in peer review, during which the medical writer will critically assess the quality of the manuscript according to common appraisal criteria, thereby augmenting the traditional subject-matterexpert review (appendix i). • medical writers could also be involved in pre-publication vetting, act as trainers, or both (see section 3.2). as professional medical writers and communicators, we have identified areas that could benefit from increased quality assurance. we have suggested some processes that we believe would better ensure effective oversight of scientific and medical publications, whether in the context of a health emergency or not. to maintain confidence in published science, each involved party (including the reader) must take responsibility for exercising their best judgment and selecting information from sources with good publishing practices that are rigorous and transparent. 5. acknowledgments this joint position statement was reviewed and approved by representatives of amwa, emwa, and ismpp. it was also reviewed and approved by representatives of efspi (european federation of statisticians in the pharmaceutical industry). preparation of this statement was possible thanks to the efforts of the members of the writing committee (slavka baronikova, beatrix doerr, art gertel, andrea rossi, emwa; gail v. flores and dikran toroser, amwa; jackie marchington and rob matheis, ismpp; and todd pesavento, the ohio state university). also, we thank the independent reviewers, alison abritis, andrea bucceri, andrea cortegiani, martin delahunty, lisa chamberlain-james, paolo morelli, roger pickett, gregory a. poland, thomas m. schindler, and amy whereat for their review, insights into further actions, and encouragement. 6. appendices appendix i: reviewers’ checklist 7. references 1. rennie d, flanagin a. three decades of peer review congresses. jama j am med assoc. 2018;319(4):350-353. doi:10.1001/jama.2017.20606 2. palayew a, norgaard o, safreed-harmon k, andersen th, rasmussen ln, lazarus jv. pandemic publishing poses a new covid-19 challenge. nat hum behav. 2020;4(7):666-669. doi:10.1038/s41562-020-0911-0 3. mehra mr, desai ss, ruschitzka f, patel an. retracted: hydroxychloroquine or chloroquine with or without a macrolide for treatment of covid-19: a multinational registry analysis. lancet. 2020;0(0). doi:10.1016/s0140-6736(20)31180-6 4. mehra mr, desai ss, kuy s, henry td, patel an. cardiovascular disease, drug therapy, and mortality in covid-19. n engl j med. 2020;382(25):e102. doi:10.1056/nejmoa2007621 5. amwa-emwa-ismpp joint position statement on the role of professional medical writers. 2017. accessed november 27, 2017. http://journal. emwa.org/writing-better/amwa-emwa-ismpp-joint-position-statementon-the-role-of-professional-medical-writers 6. biorxiv. advancing the sharing of research results for the life sciences. biorxiv. accessed september 21, 2020. https://www.biorxiv.org/aboutbiorxiv 7. medrxiv. submit your article to biorxiv, an online archive and distribution service for preprints in the life sciences. medrxiv. accessed september 21, 2020. https://www.biorxiv.org/submit-a-manuscript 8. preprints.org. preprints.org: how it works. preprints.org. accessed september 21, 2020. https://www.preprints.org/how_it_works#screen 9. levchenko m. preprints in europe pmc: reducing friction for discoverability. europe pmc. accessed september 21, 2020. http://blog. europepmc.org/2018/07/preprints.html 10. iwema cl, ladue j, zack a, chattopadhyay a. search.biopreprint: a discovery tool for cutting edge, preprint biomedical research articles [version 2; referees: 2 approved]. f1000research. 2016;5. doi:10.12688/ f1000research.8798.2 11. abdill rj, blekhman r. tracking the popularity and outcomes of all biorxiv preprints. elife. 2019;8. doi:10.7554/elife.45133 12. fraser n, momeni f, mayr p, peters i. the relationship between biorxiv preprints, citations and altmetrics. quant sci stud. april 2020:1-21. doi:10.1162/qss_a_00043 13. gertel a. the data economy | rush to publication – what do we have to lose? med writ. 2020;29(2). accessed september 21, 2020. https://journal. emwa.org/the-data-economy/rush-to-publication-what-do-we-have to-lose 14. maslove dm. medical preprints – a debate worth having. jama j am med assoc. 2018;319(5):443-444. doi:10.1001/jama.2017.17566 15. penfold nc, polka jk. technical and social issues influencing the adoption of preprints in the life sciences. shafee t, ed. plos genet. 2020;16(4):e1008565. doi:10.1371/journal.pgen.1008565 16. f1000research. about f1000research | how it works | beyond a research journal. f1000research. accessed september 21, 2020. https://f1000research.com/about 17. wiley. catheterization and cardiovascular interventions. author guidelines. wiley. accessed september 21, 2020. https://onlinelibrary. wiley.com/page/journal/1522726x/homepage/forauthors.html 18. bell gp, kvajo m. tackling waste in publishing through portable peer review. bmc biol. 2018;16(1):146. doi:10.1186/s12915-018-0619-z 19. taylor & francis. article transfers author services. taylor & francis. accessed september 21, 2020. https://authorservices.taylorandfrancis. com/peer-review/transfers 20. wiley. free format submission. wiley. accessed september 21, 2020. https://authorservices.wiley.com/author-resources/journal-authors/ prepare/free-format-submission.html 21. tennant jp, ross-hellauer t. the limitations to our understanding of peer review. res integr peer rev. 2020;5(1):6. doi:10.1186/s41073-020-00092-1 22. battisti wp, wager e, baltzer l, et al. good publication practice for communicating company-sponsored medical research: gpp3. ann intern med. 2015;163(6):461-464. doi:10.7326/m15-0288 continued on page 63 http://journal.emwa.org/writing-better/amwa-emwa-ismpp-joint-position-statement-on-the-role-of-professional-medical-writers https://www.biorxiv.org/about-biorxiv https://www.biorxiv.org/submit-a-manuscript https://www.preprints.org/how_it_works#screen http://blog.europepmc.org/2018/07/preprints.html https://journal.emwa.org/the-data-economy/rush-to-publication-what-do-we-have-to-lose https://f1000research.com/about https://onlinelibrary.wiley.com/page/journal/1522726x/homepage/forauthors.html https://authorservices.taylorandfrancis.com/peer-review/transfers https://authorservices.wiley.com/author-resources/journal-authors/prepare/free-format-submission.html 62 amwa journal / v36 n2 / 2021 / amwa.org reviewers’ checklist this checklist is intended to be used by journals. however, it can also guide authors and medical writers in their review of manuscripts before submission. the checks should be performed by a suitably qualified team, preferably consisting of editors, subject matter experts (ie, peer reviewers; not required for preprints), medical writers, statisticians, and trained researchers. the review team should comprise at least two reviewers. not every reviewer is required to complete all fields, but all items need to be checked by at least one accountable reviewer. item medical writer reviewer clinical reviewer biostatistical reviewer peer reviewer a peer reviewer b source documents (if available and required by journal) clinical study protocol redacted clinical study report synopsis statistical analysis plan tables/listings/graphs attestations data sharing statement (icmje template) author contribution forma signed author forms confirming that the authors had full access to the data reported in the article and accept responsibility for submitting the articleb author confirmation that verified data were used to develop the manuscript conflict of interest statement (icmje template recommended) list of sources of funding for the study and any supporting activities suggested checks for preprint editorial review manuscript contains no offensive or nonscientific content no material is plagiarized basics of the statistical methods are sound (eg, adequacy of analysis population, adequate handling of missing data) end points and inclusion/exclusion criteria are in alignment with the study registration on a publicly available registry (eg, clinicaltrials.gov), provided this is required. for primary reports of clinical trials, all end points are mentioned in the results section. content is consistent and clear across each section of the manuscript (eg, information in abstract matches results, hypothesis posed in introduction is addressed in discussion) discussion points and conclusions are supported by the reported data adherence to guidelines (eg, consort, strobe, prisma, spirit, care) specify guideline(s):______________________ no ethical concerns additional checks for peer review further statistical considerations: adequacy of sample size calculation (eg, adequate comparator) adequacy of statistical methods check for random errors sources of bias addressed methodological qualityc confounding influences (eg, concomitant treatments) inadequate disclosure of information misinterpretation study designb adequacy and relevance of endpoints adequacy of inclusion/exclusion criteria blinding adequacy of follow-up period adequacy of reporting complications adequacy of data presentation ashould include a question if medical writing support was used. bmay be merged with author contribution form. cadapted from meddev 2.7/1; alternatively, other criteria can be used to appraise the manuscript (eg, https://libguides.napier.ac.uk/litrev/critapp). additional columns and signature lines can be added as needed. https://libguides.napier.ac.uk/litrev/critapp amwa journal / v36 n2 / 2021 / amwa.org 63 23. icmje. recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals. icmje. 2019. accessed september 21, 2020. http://www.icmje.org/ recommendations 24. matcham j, julious s, pyke s, et al. proposed best practice for statisticians in the reporting and publication of pharmaceutical industry-sponsored clinical trials. pharm stat. 10(1):70-73. doi:10.1002/pst.417 25. ethical guidelines for peer reviewers (english) | cope: committee on publication ethics. doi:10.24318/cope.2019.1.9 26. the editors of the lancet group. learning from a retraction. lancet. 2020;396(10257):1056. doi:10.1016/s0140-6736(20)31958-9 27. jacobs a. adherence to the consort guideline in papers written by professional medical writers. med writ. 2010;19(3):196-200. 28. gattrell wt, hopewell s, young k, et al. professional medical writing support and the quality of randomised controlled trial reporting: a cross-sectional study. bmj open. 2016;6(2):e010329. doi:10.1136/bmjopen-2015-010329 29. bailey m. science editing and its effect on manuscript acceptance time. j am med writ assoc. 2011;26:147-152. 30. hamilton cw, gertel a, jacobs a, marchington j, weaver s, woolley k. mythbusting medical writing: goodbye ghosts, hello help. account res. 2016;23(3):178-194. doi:10.1080/08989621. 2015.1088788 31. woolley kl, ely ja, woolley mj, et al. declaration of medical writing assistance in international, peer-reviewed publications and effect of pharmaceutical sponsorship. fifth int congr peer rev biomed publ chicago. 2006;296(8):932-934. doi:10.1001/ jama.296.8.932-b 32. breugelmans r, barron jp. the role of in-house medical communications centers in medical institutions in nonnative english-speaking countries. chest. 2008;134(4):883-885. doi:10.1378/chest.08-1068 33. manring mmm, panzo ja, mayerson jl. a framework for improving resident research participation and scholarly output. j surg educ. 2014;71(1):8-13. doi:10.1016/j.jsurg.2013.07.011 34. woolley kl, lew ra, stretton s, et al. lack of involvement of medical writers and the pharmaceutical industry in publications retracted for misconduct: a systematic, controlled, retrospective study. curr med res opin. 2011;27(6):1175-1182. doi:10.1185/0300 7995.2011.573546 35. chipperfield l, citrome l, clark j, et al. authors’ submission toolkit: a practical guide to getting your research published. curr med res opin. 2010;26(8):1967-1982. doi:10.1185/03007995. 2010.499344 36. the equator network | enhancing the quality and transparency of health research. accessed september 21, 2020. https://www. equator-network.org dia june 27 to july 1, 2021 virtual https://www.diaglobal.org/flagship/dia-2021 regulatory affairs professionals society september 12-15, 2021 virtual https://www.raps.org/regulatory-convergence national association of science writers october 8-11, 2021 boulder, colorado, and virtual https://www.nasw.org/events/sciencewriters2021 international society of managing and technical editors october 11-14, 2021 virtual https://www.ismte.org/page/conferences international conference on communication in healthcare october 17-20, 2021 virtual https://achonline.org/icch2021 american public health association october 24-27, 2021 denver, colorado, and virtual https://www.apha.org/events-and-meetings/annual amwa medical writing & communication conference october 27-29, 2021 virtual www.amwa.org/conference association of health care journalists october 28-31, 2021 austin, tx https://healthjournalism.org/calendar-details.php?id=2245 european medical writers association november 4-6, 2021 cascais, portugal https://www.emwa.org/conferences/future-conferences/ calendar of meetings please confirm with individual meeting hosts www.amwa.org/conference 2021 amwa medical writing & communication conference october 27-29, 2021 coming to a device near you trends and opportunities for medical communicators continued from page 61 amwajournal.org 19session reports addition, utilizing a collaborative authoring platform, such as sharepoint, enables multiple writers to work on a document concurrently. as documents are further developed, tools such as table, listing, and figure tools are available to help format and present data clearly to reviewers. lastly, as a large amount of data are presented in regulatory documents, it is essential to have a quality control tool in place to ensure a document is ready for submission. documents in the rotational training program at merck, drs carr, mageau, and xu were able to gain hands-on experience and participate in shadowing opportunities to develop an understanding of the types of documents that medical writers author. during that time, they learned how documents were built during the authoring process, shadowed the quality control group, attended consensus meetings, and eventually transitioned to being lead authors. soft skills lastly, further developing self-management and people skills helps to strengthen a medical writer’s ability to work collaboratively even while remote, build connections, and maintain high productivity. medical writers are responsible for leading meetings and managing a team to build a cohesive document. having strong people skills is critical to achieving this goal. when transitioning into a regulatory medical writing role, there are several transferrable skills that can be utilized from previous experiences, including soft skills, technical skills, and core knowledge. to further prepare new writers, numerous training opportunities are offered through organizations such as nih, local regulatory affairs forums, and more. lastly, amwa provides a recommended training outline focusing on core knowledge and skills, documents, and soft skills that further helps to bridge any knowledge gaps for new writers entering the everchanging field. stephany panlilio is a senior associate in medical writing at gilead sciences, inc. (foster city, ca) author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. author contact: stephany.panlilio@gilead.com * * * growing your career as an editor speakers crystal herron, phd, els, redwood ink, san francisco bay area, ca loretta bohn, els, rti international, research triangle park, nc erica goodoff, els(d), the university of texas md anderson cancer center, houston, tx by angela trenkle, bs being a strong editor is a skill set that can open many doors in the medical writing field. in this panel session, three editors discussed some of their tips and tricks for navigating the world of editors. how editing and writing differ ms goodoff began by explaining that writing is almost like a brain dump; you are just writing everything that is in your mind with regard to the topic. editing requires more of a critical thinking piece: i have content, but how do i shape it? dr herron added that emotional intelligence is also an important skill to have for editing so that you can eloquently explain your proposed changes to authors. ms bohn also emphasized that editing is not personal and that editors are looking at the writing from a different perspective—advocating for readers. all three of these editors mentioned that it was important to explain why you’re recommending the changes and to back up your suggestions with data and resources. key skills for editing grant proposals ms goodoff began by stating that a key skill for editing grant proposals is to find ways to make it as effortless as possible to read the text and to make sure that the logic flows and ties back to the main objective. dr herron emphasized that the storytelling element of the research project is important, which includes how the research project is expected to end. ms bohn pointed out the navigation pane in word, which is a good way to look at pieces of a grant for consistency. all three mentioned the importance of cutting down the length and wording and ensuring that the entire document is consistent in flow. teaching/mentoring editors ms goodoff began by discussing how coaching new colleagues in editing differs from editing when the client is the only one who will see your edits. it can be helpful to teach new editors because it helps you to become a better editor, but you must find that balance between fixing the problems and teaching the new editor to do it themselves. with http://www.amwajournal.org amwajournal.org 20session reports colleagues, it can be complicated because you’re editing someone else’s editing, so it’s important to check your ego at the door. dr herron suggested specifically that freelancers try to find another editor that they can trust and learn from because, most of the time, freelancers are working alone. ms bohn also added to this by emphasizing the importance of having a more organized approach when meeting with someone and suggested cross-teaching so you can learn from each other. working remotely ms bohn began by mentioning that the skills are the same, but mentoring someone that you aren’t in the same room with requires a unique approach. ms goodoff chimed in and agreed that the core editing skills are the same, but the presentation of the information is different when working remotely. she had to learn a lot of new technology and noted that you don’t get the same chance to rely on audience reactions, but you can write a tentative script while presenting on zoom. dr herron added the suggestion that you can post a sticky note with a person drawn on it near your camera; that way you have “someone” to talk to and look at near the camera, which will help your audience connect with you. ms bohn closed by suggesting a fake commute at home, something that signifies the beginning and the end of your workday. angela trenkle is a preclinical technical writer at bioqual, inc., and is based in the washington, dc, area author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: angelatrenkle@gmail.com * * * remote but not alone: navigating difficult personalities when you work from home speaker melissa christianson, phd, whitsell innovations, inc., chapel hill, nc by stacie marsh, mpa, cph, gpc collaborative medical writing requires leadership from professional medical writers to guide teams of people toward the common goal of completing documents with clarity, precision, and adherence to third party guidelines, often within challenging timeframes. medical writing teams typically include groups of individuals from widely varying backgrounds, areas of expertise, priorities, pressures, and communication styles. medical writers must foster effective teamwork in order to successfully lead their teams toward achieving their common goal. the pandemic has forced more writing teams to collaborate in a virtual environment, requiring medical writers to recognize and navigate team dynamics and interpersonal intricacies in creative ways. dr christianson’s presentation at the american medical writers association (amwa)’s 2021 medical writing and communication conference identified the most common personality types among difficult members of medical writing teams and provided specific strategies for navigating these traits in a virtual environment. defining and recognizing difficult behaviors the first step in dealing with difficult behaviors is recognizing that they exist. although perceptions of difficult behaviors vary by the individual assessing the behavior, difficult behaviors and attitudes typically refer to those that are misaligned with the expectations of the writer and the team. dr christianson illustrated the most common types of difficult behaviors in a behavior categories axis (figure). group 1 includes those who are narrowly focused with tendencies to approach a project in a way that mismanages the writers time, attention, and processes, and ultimately impedes the writer’s ability to move a project forward in an optimal timeframe. examples of group 1 traits include micromanagers, digressers, know-it-alls, worriers, and wordsmithers. those in group 1 may be concerned about proving their own worth or getting blamed for less-than-optimal outcomes for reasons such as job vulnerability or being new in a position with perhaps lesser credentials that other team members. group 2 includes those who are more broadly focused but aggressively approach projects. these behaviors conjure *this manuscript is based on a session at the 2021 amwa medical writing and communication conference. figure. top left (group 3); top right (group 1); bottom left (group 4); bottom right (group 2) group 2 includes those who are more broadly focused but aggressively approach projects. these behaviors conjure an elephant barreling through a meeting, causing chaos in their wake. examples include those with strong egos, often short tempers, and who are prone to derail a team’s progress in unpredictable ways. individuals displaying these tendencies may not realize the value of writers in handling important team functions. group 3 includes those who are more narrowly focused on a project yet withdrawn or disengaged from specific tasks at hand. these individuals tend to be reticent to voice their opinion or make an important contribution until a problem arises, vacillate, and fail to provide clarity to move forward, stall a meeting’s progress, and generally underdeliver on their intended roles and contributions. reasons for these behaviors can be attributed to cultural complexities, competing priorities, and simple unawareness of what is expected of them as part of the medical writing team, among others. finally, group 4 includes those who approach a project from a broad perspective but whose actions withdraw from the functions or goals of the team. individuals displaying these characteristics tend to be pessimists, complainers, rumormongers, blamers, deceivers, and dismissers. unfortunately, these are often the most common types of difficult behaviors and influence the tone and dynamic of entire teams in a negative manner. these behaviors are often exacerbated by—and sometimes a result of—ineffective communication from project leaders, including medical writers leading cross-functional teams. dealing with difficult behaviors approachwithdraw narrow focus broad focus reticent vacillator under-deliverer staller micromanager worrier know-it-all rumormonger pessimist dismisser complainer blamer deceiver tank exploder egoist digresser wordsmith figure. top left (group 3); top right (group 1); bottom left (group 4); bottom right (group 2). http://www.amwajournal.org contents v37 n1 spring 2022 3 4 11 16 29 35 38 from the editor amwa journal on open journal systems � michael g. baker conference 2021 swanberg award tribute lori l. alexander, mtpw, els, mwc – a tribute � susan krug and cynthia l. kryder 2021 john p. mcgovern award address style and substance � stacy l. christiansen session reports • best practices for medical writing with a disclosure mindset • bridging the gap: transitioning into regulatory medical writing • growing your career as an editor • remote but not alone: navigating difficult personalities when you work from home • sales training and beyond: developing educational content across the pharma/biotech landscape • teaching the next generation of regulatory medical writers • the quick and the dirty: best practices for writing and editing under tight timelines • time to clock in: applying manufacturing best practices to consistently and efficiently produce high-quality documents 2021 conference sponsors and exhibitors feature digital enhancements of scientific content at virtual and hybrid conferences � qing zhou research agile strategies in the rigid regulatory environment � jeanette m. towles and jason s. casavant 45 38 35 editor-in-chief michael g. baker, phd managing editor rachel mosher, ma section editors practical matters qing zhou, phd, els regulatory insights jennifer bridgers, ms, mwc science series paul c. dolber, phd social media jennifer minarcik, ms statistically speaking thomas m. schindler, phd everyday ethics julie ravo, ba, ma freelance focus ruwaida vakil, msc technology talk kate mckiernan, ma, els regular contributors freelance focus brian bass, mwc melissa l. bogen, els sherri bowen, ma, els lori de milto, mj cathryn d. evans gail v. flores, phd phyllis minick in the service of good writing laurie endicott thomas, ma, els editor at large haifa kassis, md editors in memoriam lori l. alexander, mtpw, els, mwc ronald j. sanchez 2021–2022 president katrina r. burton, bs 2021–2022 board liaison r. michelle sauer gehring, phd, els 2021–2022 staff liaison shari rager, ms, cae executive director susan krug, ms, cae graphic designer amy boches, biographics editorial office: managingeditor@amwa.org. instructions for authors available at: www.amwajournal.org. advertising: contact marketing@amwa.org or (240) 239-0940. all advertising is subject to acceptance by amwa and should be for products and services relevant to professional medical communicators. amwa is not responsible for the content of advertising and does not endorse any advertiser or its products or services. subscription: the amwa journal is published quarterly. subscription is included with amwa membership. nonmember subscriptions cost is $75 per year. contact: american medical writers association, 30 west gude drive, #525, rockville, md 20850-4347. phone: (240) 238-0940; fax: (301) 294-9006; email: amwa@amwa.org. the amwa journal is in the mla international bibliography and selectively indexed in the cumulative index to nursing and allied health literature (cinahl) print index and the cinahl database. the opinions expressed by authors contributing to the journal do not necessarily reflect the opinions of amwa or the institutions with which the authors are affiliated. the association accepts no responsibility for the opinions expressed by contributors to the journal. ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwa journal mission statement in support of the mission of the american medical writers association (amwa) and to advance the broader profession, the amwa journal publishes content that reflects the interests, concerns, and expertise of medical communicators. its purpose is to inform, inspire, and motivate medical communicators. m o re v37 n1 / 2022 45 biography john p. mcgovern, md – physician, entrepreneur, philanthropist � tom lang 50 freelance focus brian bass, melissa l. bogen, cathryn d. evans, gail v. flores, and ruwaida vakil q1: in the new digital age, what are some of the changes you have been making as a medical writer? q2: what software do you recommend to a new freelancer? q3: what are the pros/cons of using grammar or proofreading software such as grammarly or perfectit? 54 everyday ethics legal and ethical issues in technical content marketing � scott a. mogull 60 amwa news from the president � katrina r. burton 62 calendar of meetings contents http://www.amwajournal.org positions now open for medical writers in the us and canada. do you want to make a change as a medical writer? visit us at trilogywriting.com writers@trilogywriting.com where was it written that medical writing had to be dry, mediocre or uninspiring? sadly, it was everywhere we looked. in regulatory reports duller than butter knives. in poorly summarized summations. subpar medical writing was everywhere and spreading. so we did something about it. we waged war against mediocrity to make a change. think you have what it takes to join a world-leading team of medical writers? we’d love to speak with you. mailto:writers@trilogywriting.com v37 n1 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 3 from the editor & guest editor we hope you share our excitement that the american medical writers association (amwa) journal has gone digital on the open journal systems (ojs) platform. ojs is cloud hosted, community-led open-source software that allows us to provide the journal in an enhanced format, with features that include • direct access to subscriber-only content via your amwa member login, • easy indexing and discoverability, as recommended by google scholar, • article abstracts in html format, which is ideal for search engine crawlers (keywords), and • doi indexing (forthcoming). a full pdf version each issue of the amwa journal will continue to be available to you via download from the amwa journal site on ojs. archive issues will be debuted on the site as we continue to build up our presence online. our initial online issue is dedicated to exploring trends and opportunities in medical communication, the theme of the 2021 amwa annual conference. our transition to a digital platform is in keeping with trends in our field, with other medical communication trends to be explored in future theme-based that will be announced on the amwa journal site. we encourage you to write for the journal on a topic for an upcoming theme or for any of our regular sections. amwa journal will continue to bring you great content every quarter and we welcome your input on the digital format. amwa journal on open journal systems michael g baker, phd editor-in-chief shari rager, ms, cae 2021-2022 staff liaison http://www.amwajournal.org v37 n2 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 21 a popular session during the annual conference was the jam session for seasoned freelancers. the session gives seasoned pros the chance to share experiences and discuss ideas, concerns, and challenges with peers who have the same or even more experience. a range of important topics were discussed at this year’s session. these include managing stress, email issues, travel and security issues, sculpting your business, friendships with colleagues, referring clients, legal battles, and one of the costs of doing business. in this issue, we will cover the first 4 topics. managing stress saying no is probably the seasoned freelancer’s greatest weakness. the no muscle can be strengthened by paying more attention to red flags that indicate a client may not be ideal to work with, such as being disorganized, and cutting that client loose. giving yourself a day off every now and then, or better yet, a permanent 4-day work week, is another great way to take control of your freelance business and lower your stress level. another way to manage stress is to slow down. delivering an assignment early is a great way to endear yourself to a client, but it can also set the expectation that you don’t need as much time as other freelancers to get great work done. slowing down doesn’t mean you should start taking longer to complete assignments. rather, you might sit on the completed project for an extra day or 2 before you deliver it—still early, but not as early. subcontracting is another option for managing heavy workloads. seasoned freelancers who subcontract warn that subcontracting isn’t easy and can actually lead to more rather than less work for the freelance business owner. tips from seasoned freelancers doing excellent work for our clients and delivering it on time and on budget while running a freelance business is often stressful. but with the right business practices, we can manage stress. we need to say no to working with new clients that are likely to be bad clients and to unreasonable demands from current clients. if we are working with bad clients, we need to fire them. although it’s scary to do this, there are lots of great clients out there who need our help. if you’re working with a client that depletes your energy and increases your stress, then you won’t have the time or energy to find or work with better clients. training our clients also reduces stress. we need to set boundaries about when we work and require reasonable deadlines. if we answer emails or phone calls on evenings or weekends or agree to unreasonable deadlines, clients will always expect us to do this. let your clients know your normal business hours and review each project carefully to ensure that you can make the deadline with your normal work schedule. make it clear to the client that if they do not do their part (eg, sending you source materials or reviewing your work), you cannot meet the deadline. although it’s always great to deliver a project a little early, don’t turn it in too early or the client will always expect this. all of the usual stress management techniques help too. simple things like deep breathing, which you can do anytime, make you feel better right away. meditation, exercise, being in nature, and eating healthily are other ways to manage your stress. i started meditating shortly after the start of the pandemic, using the insight timer app. insight timer has 100,000 free guided meditations on 200 topics, including stress and anxiety. i mostly do short meditations (3 to 10 minutes). —lori de milto brian bass, with commentary from melissa l. bogen, lori de milto, cathryn d. evans, gail v. flores, and phyllis minick jam session for seasoned freelancers—part 1 freelance focus brian bass melissa l. bogen gail v. flores phyllis minicklori de milto http://www.amwajournal.org amwajournal.org 22jam session for seasoned freelancers—part 1 my answer: managing stress daily is a high priority for me. by taking specific actions, i can maintain productivity and enjoyment of my work. if i am not vigilant about managing my stress levels, a sense of overwhelm can threaten to derail me. specific actions to manage stress • exercise: a commitment of pilates classes on zoom twice a week keeps me accountable and somewhat active. i did a 6-week fitness challenge at a local gym, but covid dissuaded me from continuing the challenge. huffing and puffing into a mask at the gym while others didn’t necessarily wear a mask wasn’t to my liking, so i’ve replaced the gym with doing exercise programs on youtube in my living room. some programs i like are yoga with adriene (https://www.youtube.com/user/yogawithadriene), has fit (https:// www.youtube.com/c/hasfit), and fitness with pj (https://www.youtube.com/c/fitnesswithpj). • stay hydrated: drinking water is important. my goal, 2 large glasses before and after lunch, forces me to take frequent trips to the bathroom. these short excursions are an ideal time to stretch and focus my eyes farther away than the monitor. i live on a lake, so there’s always something pretty to see. • eat at regular intervals: i need to keep my body fueled to think and perform well throughout the day. if you’re like me and don’t have time to cook, consider a food delivery service, whether online like hello fresh (https://www.hellofresh.com/), mosaic foods (https://www.mosaicfoods.com/), etc, or simply local takeout. keeping cut-up vegetables around helps me snack on something healthy. • maintain regular hours: once i’m off the clock, i don’t respond to work-related email and i tend to stay away from my computer. i need time when i am not working to relax. • engage in a hobby: humans are not meant to just eat, sleep, and work. we need social engagement and creative outlets. social engagements have been tricky during covid. participation in regular nonwork zooms with friends from around the country and my family help me feel less isolated. but i also need to see people i know in person! i hike with local friends. getting out in nature, even a simple walk around the block, invigorates me. i need creativity in my life—coloring in adult coloring books, dancing to music, or gardening (or looking at garden catalogs in the winter) are all restorative activities. —melissa l. bogen my best response to addressing this issue is a quote: in speaking of the new year, richard branson, although not an acknowledged sage but unquestionably a remarkable success, wrote that "every success is a tale of constant adaptation, revision, and change." so, my interpretation of that response is this: may none of us focus on fear. if something new or stressful is happening in your life, take courage. if you face anxiety, turn to the excitement of possibilities, because it takes only one step to begin breaking any barrier. use the power of your ability for communication to change a system, a status quo, or even the heart of people to make a difference in this world. i am thankful for the spirit of learning and wisdom that amwa fosters to help others, to share friendship, and to anticipate new beginnings. —phyllis minick * * * addressing the email address issue most seasoned freelancers have a hard enough time keeping up with their own email addresses. for them it would be onerous to have to constantly check other email addresses as well. they solve the problem by having their client addresses forwarded to their regular email address. some seasoned freelancers prefer to keep their own email addresses separate from their client email addresses. one way to do this and keep your sanity is to manage each email address on a different browser. tips from seasoned freelancers i hope others will describe how to maintain client-specific emails when they are forwarded to one email account. in the past, i have been given up to 2 client email accounts. i preferred to not have those emails forwarded to my personal email address. for me, it was easier to maintain each email account separately by webmail. each morning i launch my personal email (on mozilla thunderbird). i also launch 2 tabs in my browser for the 2 separate client email accounts. i check email in my personal email account with immediate notifications. i keep my speakers off so the notifications are silent. these notifications appear as a small red number on my email icon in the taskbar (the icons at the bottom of my monitor). i can easily ignore or check my personal email as i see fit. i keep track of each client’s emails by switching through the accounts throughout the day. typically, i check the client email accounts about 4 times per day: first thing in the morning, before and after lunch, and at the end of the day. i give my clients my cell phone so that if they have an urgent http://www.amwajournal.org https://www.youtube.com/user/yogawithadriene https://www.youtube.com/user/yogawithadriene https://www.youtube.com/c/hasfit https://www.youtube.com/c/hasfit https://www.youtube.com/c/fitnesswithpj https://www.hellofresh.com/ https://www.mosaicfoods.com/ amwajournal.org 23jam session for seasoned freelancers—part 1 need, they can always contact me immediately during my regular office hours. however, clients rarely text me. one client likes to use slack (https://slack.com/), software that allows private chat rooms/groups and direct messaging. slack’s immediate notification means i never miss a timely communication. —melissa l. bogen in recent years, about half of my clients have required me to use an email account housed in their organization. i’ve set them all up in my outlook along with my medical writing business email account, so i can scan my emails from all of my current clients at the same time. i’ve found it very helpful for organizing emails by project and client in my outlook, and it allows me to filter out my other clients when i need to focus on correspondence related to active projects. the only email account i don’t access through outlook is my personal email account. i only check my personal email account through an internet browser, so that i don’t get distracted by personal emails during the workday. —gail v. flores in a recent email, purportedly from costco, i was asked to answer 3 questions about customer satisfaction—a feature that amazon and others use frequently (and i respond to those occasionally to express appreciation of good service). this time, i was offered a wristwatch with a “fall accident” feature. the only cost was postage. “ok,” i wrote to accept. my son said, “mom, you’ve been scammed. cancel your credit card.” i called costco visa and was told that the charge was $8.95 but that there was no need to cancel the card; visa would protect me. also, i was given the charge company's phone number. the agent who answered said, “your watch will be delivered tomorrow, and your earpods will soon follow for $35.” i cancelled the earpods, charges, and (supposed) account. incidentally, that call was my second scam email of that 1 day. that said, i’ve done editing jobs by email in 6 countries for years. the only change i’ve added to my system is a separate email address for clients. i never use that email address to buy anything! consequently, i never receive ads or unsolicited responses on that site. i also have a separate bank account to receive online payments for completed jobs. immediately after payment arrives, i transfer the money to another business account. —phyllis minick * * * travel security and sanity tapping into airport or hotel wi-fi can expose you to a host of security issues. when traveling, seasoned freelancers rely on their security software for protection. norton, trend micro, and malware bytes come to mind. some seasoned freelancers go so far as to have their own virtual private network (vpn) for travel security. and for both security and sanity, never check email on your phone when you travel, especially when you’re on vacation. set your out-of-office message and walk away from the inbox. tips from seasoned freelancers for the last 2 years i have not stayed in a hotel and have traveled only by car. in the past, i took up to 15 trips per year: i have never worried about “security” vis à vis email or wi-fi while traveling—and i check my email by iphone and ipad regularly. even when traveling by air, i always sign on to the airport wi-fi and have never had a problem with hackers. some of my clients like to send text messages regularly and of course i review these while traveling—sometimes i prefer text messaging, even if the messages are very long, because it is so much simpler while traveling. —cathryn d. evans * * * business sculpting freelance medical writers often get their start in one area of the business, like scientific publications, and over the years find their interests wander. freelancing gives us the flexibility and the opportunity to explore other areas and sculpt our businesses accordingly. rather than resist the urge to branch out, seasoned freelancers should embrace their passions and pursue other interests that can allow their freelance businesses grow. tips from seasoned freelancers as a freelance business grows, it’s common for seasoned freelancers to get so busy that we don’t take time to think about the type of work we’re doing. then one day we realize that we’d like to add other types of medical writing or transition out of the work we’re currently doing to other types of medical writing. one of the joys of freelancing is that we do get to choose our clients and our projects. if you’re not doing what you want to be doing, set aside a few hours when you can think strategically about your business and develop a plan. consider other types of work you want to do and how you can make the http://www.amwajournal.org https://slack.com/ amwajournal.org 24jam session for seasoned freelancers—part 1 transition to those types of work. can current clients give you new types of work? who in your network does what you want to do and might help you? continue doing the work you’re known for as you add or transition into new types of work. every 6 months or so do another strategic planning session. review your progress and the type of work you most want to do. —lori de milto this is truly an important question for all of us. i started out targeting “pharmaceutical industry” clients because i had worked for several years as a full-time medical writer for a drug company. note, however, that during all those years, my experience included not only scientific publications and regulatory affairs but also marketing communication, sales-training projects, continuing medical education and patient education materials, writing and designing educational and scientific exhibits, writing press releases, and covering medical meetings. so my “focus” on pharma/ biotech clients was by no means limited to clinical regulatory affairs. i point this out here because i feel those who have worked in the industry may have a better advantage than they realize. an underpinning to all of these topic areas is understanding deeply the process of the development of new drugs/biologicals as well as strong familiarity (experience) with food and drug administration regulations. no matter what you do in the pharma/biotech industry, regulations will be a ghost in the background—so learn the regulations as well as the product development process. over the years as a freelancer, i have also worked for hospital systems, creating or modifying website copy, writing practitioner profiles, or creating brochures, and for managed care companies, writing provider manuals, standard operating procedures, responses to patients, and educational material. the background in pharma/biotech enabled me to branch out this way quite easily. incidentally, i became a certified yoga instructor as well as a certified acupressure/shiatsu practitioner while freelancing. thousands of hours devoted to classes for these certifications because i love both practices and did them part-time while freelancing as a medical writer. think about your present expertise and how/where you might branch out. take classes in the new area, if you can. do your homework and then move. but please . . . never, ever tell a client you have experience doing something when you do not! study, learn, practice first—then do it for a client. —cathryn d. evans there’s more to come from the 2021 jam session in next month’s issue of the amwa journal. unlock the secrets to freelance success with this 3-part on-demand video series. gain relevant and practical advice from industry pros. run your business like a pro. • essential ingredients of a successful freelance business • bad behaviors that can sabotage your business • getting the clients you deserve unlock now in amwa online learning: www.amwa.org/freelance_success http://www.amwajournal.org a m w a news gail v. flores, phd / 2020–2021 amwa president from the president spring forward as i write this article, we are 1 month into spring. this season is traditionally known as a time of regrowth and renewal, when the flowers start to bloom and the birds being to chirp—and baby animals enter the world, perhaps with some hesitation, yet also with optimism. this spring in the united states, many of us are feeling a parallel with the season, as to a certain degree, we are emerging from the covid-19 pandemic with both hesitation and optimism. however, we are not returning to the pre-2020 world; rather, we are learning to adapt as we create our new normal. i wish we had a crystal ball to show us what the world will look like in october. because we don’t, amwa leadership recently made the call to hold the 2021 amwa medical writing & communication conference virtually. this decision was driven by data, both from public health experts and from our members. the results of a recent member survey indicated that an overwhelming percentage of members would be unable or unwilling to travel in october, for reasons ranging from employer restrictions to personal issues to uncertainty about how the pandemic will continue to unfold. now that the decision had been made, we can shift our focus from concern about the ability to put on a safe, excellent, in-person conference to implementation of an amazing virtual event. the first month of spring was quite busy for amwa! in mid-march, the us house of representatives passed the protecting the right to organize act, legislation that would negatively affect the livelihood of freelance medical communicators. we quickly issued a press release stating that amwa strongly opposes this act, reaffirming our position from 2020 regarding such legislation. special thanks to lori de milto for reaching out to us directly and providing critical information and sources to help shape our response. less than 2 weeks later, an article criticizing current oncologic clinical trial design was published in jama oncology; among several arguments, a negative, if not insulting, light was cast on the role and intent of medical writers in the manuscript development process. swiftly, amwa engaged with the european medical writers association (emwa) and international society for medical publication professionals (ismpp) to submit a letter to the editor of jama oncology contesting the authors’ remarks about medical writers, refuting the statement that medical writers introduce “spin” (studies have been conducted and no such evidence exists) and noting that medical writer involvement actually improves compliance with reporting guidelines and provides more complete reporting of trial results, a greater rate of publication over time, and a lower risk of publication retraction due to misconduct. i would like to thank my amwa board of directors colleagues r. michelle sauer gehring and brian bass for their support in information gathering, resource provision, and generating many emails and calls regarding this matter. i am also very thankful to my co-authors and collaborators on the letter, thomas m. schindler and jacqueline m. marchington. in addition to reacting to these 2 emergencies, amwa also has much to celebrate this spring! on march 22, we announced that michael g. baker, phd, has been named editor-in-chief of amwa journal. he has hit the ground running, and we are all excited to watch the journal continue to evolve under his leadership. in addition, on april 1, our amwa–emwa–ismpp joint position statement on medical publication, preprints, and peer review as well as a checklist were published in current research and medical opinion. since publication, the statement has received positive press and feedback on social media. a highlight of the amwa year is recognition of those who excel in medical communication. be sure to read the articles about the worthy recipients of the highest amwa awards, the john p. mcgovern, walter c. alvarez, and harold swanberg awards, in this issue. it is such a joy to welcome stacy l. christiansen, harriet a. washington, and lori l. alexander to our circle of award recipients. there is a saying that “life isn’t about waiting for the storm to pass; it’s about learning to dance in the rain.” as we emerge from our period of waiting for the storm to pass, i hope we can learn how to dance in the rain. in this new normal, let’s continue to work hard, advocate for our profession, engage with each other, and lift each other up virtually, and put on the best virtual conference ever. let’s spring forward! yours in amwa, gail 94 amwa journal / v36 n2 / 2021 / amwa.org v37 n1 / 2022 feature ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 35 abstract since the beginning of 2020, scientific conferences around the globe have evolved quickly to adapt to a virtual or hybrid format when in-person meetings were disrupted by the covid-19 pandemic. with the digital platforms now in place to enable virtual participation, interaction with scientific content in a digital format will likely become a new norm of the scientific conference experience. digital enhancements of scientific presentations and posters may help bridge the gap of communication in a virtual format and may extend the reach of scientific content. this article provides a brief overview of common types of digital enhancements and summarizes insights from two conference organizers from their conversations at the “informed” podcast. researchers, conference organizers, and medical communication and publishing professionals will continue to optimize the digital enhancements and explore innovations to maximize the value of scientific content disseminated at virtual and hybrid scientific conferences. at traditional in-person scientific conferences, scientific content is typically delivered through oral presentations to a live audience in meeting rooms or through display of posters in large exhibition halls. in the last decade or so, even before the coronavirus disease 2019 (covid-19) pandemic, a trend toward the use of digital content had already started among many scientific conferences in which e-posters were displayed on large screens instead of on poster boards and recorded oral presentations and e-posters were made available on demand to meeting attendees after the conference. the arrival of the covid-19 pandemic in early 2020 put an abrupt stop to in-person meetings and forced all scientific conferences to quickly adapt to either an entirely virtual format in which all participants joined online, or a hybrid format that combined some on-site participation elements with virtual participation of those who were unable to travel on-site due to travel or quarantine restrictions, or who preferred to attend remotely for other reasons.1-7 with the emergence of multiple variants of (sars-cov-2), much uncertainty remains as to when the world will ever return to a pre-covid-19 state in which fully in-person conferences will resume. virtual and hybrid conference formats also opened unprecedented opportunities of wider outreach to members and audiences around the globe. as meeting organizers have already invested in and developed online platforms, these digital infrastructures will likely stay to enable hybrid conferences even after the covid-19 pandemic is over.5-7 therefore, interaction with scientific content in a digital format will likely become a new norm of the scientific conference experience. digital enhancements of scientific content at virtual and hybrid conferences what are the digital enhancements in the era of virtual and hybrid conferences? how do conference attendees interact and consume these digital enhancements? the answers to these questions are slightly different for the 2 main types of conference content, oral presentations and posters. for oral presentations, a prerecorded video of the oral presentation is usually required ahead of the conference. if a discussant is assigned to moderate a session with several talks, the discussant’s presentation that summarizes different talks may also be prerecorded. in a hybrid meeting, qing zhou, phd, els / regeneron pharmaceuticals inc, tarrytown, ny digital enhancements of scientific content at virtual and hybrid conferences http://www.amwajournal.org amwajournal.org 36digital enhancements of content at virtual conferences even when most presentations are delivered live on-site, prerecorded presentations may still be required as backup in case a presenter is unable to travel on-site. during a virtual or hybrid conference, live broadcasting of oral presentations is either delivered live, prerecorded, or a mix of both is essential to create a “live” experience for meeting attendees to listen and watch these talks for the first time. to add to the live interactions, presenters and moderators typically join live either onstage (for live presentations) or on screen (by applications such as zoom) for discussions and q&a. virtual participants can typically submit text-based questions by a chat function on the meeting platform which are then selected by the moderator for answering and discussion. for scientific posters, digital enhancements refer to additional materials beside the poster file itself on the virtual meeting platform. in the absence of face-to-face interactions between presenters and poster viewers, these digital enhancements may help bridge the gap of communication. common digital enhancements include • qr codes embedded in posters. these qr codes can link to supplementary materials such as methodological details, additional results, and additional resources. • poster slides. these slides, usually brief (eg, 5-10 content slides, as specified by the conference), provide a succinct summary of the poster, thus offering a quicker and easier read, especially on smaller screens of hand-held devices. • audio or video recording of the poster. in these recordings, the presenter can give an overview of the poster and explain certain key points of the research work. in the absence of face-to-face interactions, these recordings offer a personal touch to the virtual posters. in addition, for both oral presentations and posters, the conference platform may enable additional enhancements such as auto-generated captions or transcripts accompanying audio and video recordings. the conference platform may also allow a meeting attendee to reach out to a presenter to ask questions, thus providing an opportunity of developing professional connections that may translate into future collaborations. insights from medical societies and conference organizers several episodes on the informed podcast offered interesting insights on digital enhancements from the perspective of medical societies and conference organizers. informed is a podcast series created by the international society for medical publication professionals (ismpp), in which the host interviews different guests in episodes to talk about key trends and issues facing medical communication and publication professionals in an ever-evolving field. in episode 4 of the 2020 season,8 the podcast host rob matheis, ismpp president and ceo, interviewed travis hicks, the director of web operations at american society of clinical oncology (asco). the 2020 asco conference took place entirely in a virtual format at the end of may 2020. an important insight by hicks is that consumption of scientific content becomes the “primary focal point” of the virtual meeting experience.8 the amount of content consumed over 3 days of the virtual asco conference was impressive: 2.5 million pageviews in 2 days; and at one point 16,000 individuals were watching live, with 30,000 more viewing on-demand content. in the absence of the other social aspects of a traditional conference, attendees naturally focused on content, and many discussed the content online through social media. for digital enhancements, a big difference from previous in-person meetings is the incorporation of the poster video on the platform. it turned out that videos were the most consumed pieces, although other enhancements were also valuable such as slides for download and links to additional resources. asco also developed homegrown applications to allow meeting attendees to ask questions to presenters, which helped with building professional rapport and connections. in 2 more recent episodes in the 2021 season (episodes 3 and 4),9,10 matheis talked to david barrett, the ceo of the american society of gene and cell therapy (asgct), on navigating the changing medical conferences. in part 1 of the conversation, barrett reflected on recent experiences from virtual asgct meetings and pointed out that the aspect valued the most by attendees was the access to live meeting content (eg, live presentations or prerecorded materials) as they are being presented.9 although some technical difficulties caused temporary interruptions of content broadcasting, the meeting organizers were able to fix the problems and restore content streaming. another important aspect valued by meeting attendees was engagement with speakers during the live sessions. attendees could submit questions that were monitored by the session chair and “upvote” certain questions to the front of the line for answering. in addition, barrett reflected that the virtual format made it possible for attendees to switch from one talk to another quickly among different sessions (or “talk surfing”), which might not have been possible during conventional meetings. http://www.amwajournal.org amwajournal.org 37digital enhancements of content at virtual conferences in part 2 of the conversation that focuses on virtual display of scientific posters, barrett also emphasized the importance of poster slides and prerecorded content that can enhance the reach of virtual posters.10 the built-in feature for contacting poster authors also allowed for connections between the attendees and the presenters. initial metrics from the virtual conferences suggested that about 50% of meeting attendees visited the digital poster halls, with varied view counts of individual digital posters (ranging from low dozens to several hundreds of views per poster). although no comparison can be made due to lack of similar metrics for traditional conferences, these numbers may suggest a more active engagement with poster materials by conference attendees. looking ahead, barrett mentioned that the hybrid meeting model would likely stay, as the meeting organizers are trying to “marry” the 2 approaches of live engagement and enduring the sharing of digital contents to maximize the value of scientific conferences.10 summary and outlook scientific conferences around the globe have quickly evolved to embrace virtual and hybrid meetings in the last 2 years. the hybrid meeting approach will likely stay even after the covid pandemic and become a new norm for scientific conferences. digital enhancements of scientific presentations and posters are therefore important to bridge the gap of communication in a virtual format and may extend the reach of scientific content. still, virtual interactions may not fully achieve the effect of in-person interactions, and there are still drawbacks of digital content such as technical difficulties affecting live streaming and the need for additional resources and it capabilities to effectively manage and maintain all digital content by the meeting organizer. researchers, conference organizers, medical communicators and publishing professionals will continue to optimize the digital enhancements and explore innovations to maximize the value of scientific content disseminated at virtual or hybrid scientific conferences. author declaration and disclosures: the author notes no commercial association that may pose a conflict of interest in relation to this article. the views and opinions expressed in this article are those of the author and do not necessarily reflect the views of regeneron or its employees. author contact: qzhou.writer@gmail.com references 1. speirs v. reflections on the upsurge of virtual cancer conferences during the covid-19 pandemic. br j cancer. 2020;123(5):698-699. 2. gupta mp, sridhar j, wykoff cc, yonekawa y. ophthalmology conferences in the coronavirus disease 2019 era. curr opin ophthalmol. 2020;31(5):396-402. 3. rundle cw, husayn ss, dellavalle rp. orchestrating a virtual conference amidst the covid-19 pandemic. dermatol online j. 2020;26(7):13030/qt5h19t1jx. 4. weiniger cf, matot i. craving togetherness: planning and replanning a national society hybrid conference during the covid-19 pandemic. br j anaesth. 2021;126(3):e116-e118. 5. hameed bz, tanidir y, naik n, et al. will “hybrid” meetings replace face-to-face meetings post covid-19 era? perceptions and views from the urological community. urology. 2021;156:52-57. 6. porpiglia f, checcucci e, autorino r, et al. traditional and virtual congress meetings during the covid-19 pandemic and the post-covid-19 era: is it time to change the paradigm? eur urol. 2020;78(3):301-303. 7. hanaei s, takian a, majdzadeh r, et al. emerging standards and the hybrid model for organizing scientific events during and after the covid-19 pandemic. disaster med public health prep. 2020:1-6. https://doi.org/10.1017/dmp.2020.406 8. informed. episode 4: digital enhancements: which are worth the investment? ismpp. published august 11, 2020. accessed january 2, 2022. https://ismpp.memberclicks.net/ismpp-podcasts-2020 9. informed. episode 3: successfully navigating the changing medical conference landscape: pt. 1. ismpp. published august 10, 2021. accessed january 2, 2022. https://ismpp.memberclicks.net/ ismpp-podcasts 10. informed. episode 4: successfully navigating the changing medical conference landscape: pt. 2. ismpp. published august 31, 2021. accessed january 2, 2022. https://ismpp.memberclicks.net/ ismpp-podcasts http://www.amwajournal.org https://doi.org/10.1017/dmp.2020.406 https://ismpp.memberclicks.net/ismpp-podcasts-2020 https://ismpp.memberclicks.net/ismpp-podcasts https://ismpp.memberclicks.net/ismpp-podcasts https://ismpp.memberclicks.net/ismpp-podcasts https://ismpp.memberclicks.net/ismpp-podcasts 164 amwa journal / v36 n4 / 2021 / amwa.org abstract the american medical writers association (amwa) currently bestows 3 awards in honor of 3 of its members: harold swanberg, md, the founder of the association; walter alvarez, md, in retirement, a nationally syndicated health columnist;; and john mcgovern, md, a philanthropist who supported initiatives in biomedical communications. however, the details of the lives of these men are unknown to most amwa members. accordingly, this biography describes the life and accomplishments of walter alvarez to recognize his achievements and to contribute to the history of the profession and of the association. introduction walter alvarez was an accomplished researcher and physician. as a gastroenterologist, he was the first to identify what is now called alvarez syndrome, a medical disorder of unexplained neurotic abdominal bloating, and alvarez-waves, or painless uterine contractions that occur throughout pregnancy.1 he was among the first to call attention to food allergies,2 brought worldwide attention to what would be called psychosomatic medicine,2,3 and was an early supporter of lgbtq+ rights.2 despite these achievements, however, what he did in retirement is what caught amwa’s attention. the alvarez family walter alvarez was a remarkable man with a remarkable lineage. his father, luis f. alvarez, was born in spain, orphaned early, and taken by a relative to cuba at age 13, where he completed high school. he next went to san francisco where he learned english, graduated from medical school, and started a family.4 he eventually became a government physician in rural hawaii and was later appointed to run a new hospital for patients with hansen disease (leprosy),5 where he developed an early diagnostic test for the disease. he also became the personal physician to queen lili’uokalani of hawaii.6 walter’s sister, mable, was a renowned artist whose paintings were exhibited nationwide and are held in private collections around the world.7 his brother, milton, became a businessman in the southern philippines, in a sultanate of the islamic moro people. he was so well liked that when the sultan died, he was offered the position of sultan (he declined).3 his brother, harold, became a professor of dental surgery at the university of california medical center in san francisco and had a successful private practice.3 walter’s son, luis, was one of the most notable nuclear physicists of the 20th century. he made the first precise measurements of neutrons; invented the cyclotron, ground-controlled radar (which allows planes to land in poor visibility), the transponders that identify airplanes in flight, and a stabilizing optical system for cameras; analyzed the zapruder film of the kennedy assassination; received the nobel prize in physics; and—probably most importantly—invented the stroboscopic golf-trainer that helped president eisenhower improve his golf swing.8 walter’s grandson (luis’s son, also a walter) was a geologist and professor in the earth and planetary science department at the university of california, berkeley. he studied the phenomenon of “geomagnetic reversals,” which occur when magnetic poles trade places, and was able to estimate the dates of these reversals—over the past 100 million years.9 in 1980, he and his father proposed the “alvarez hypothesis,” which postulated that an asteroid hitting the earth ended the age of dinosaurs 66 million years ago.10 their hypothesis was confirmed in 2010.11 growing up in hawaii walter clement alvarez was born in san francisco in 1884, thomas a. lang, ma / principal, tom lang communications and training, kirkland, wa walter clement alvarez: physician • researcher • columnist biography amwa journal / v36 n4 / 2021 / amwa.org 165 the son of luis f. alvarez, md, and clementina alvarez. an older brother had died of diphtheria at the age of 4, making walter the oldest of his 4 siblings: milton, florence, mabel, and harold.3 when he was 3, the family moved to hawaii, where his father was a government physician in rural oahu caring for migrant workers in the sugar cane plantations.3,4 walter and his siblings grew up in relative isolation. his mother taught him to read, and he remained a voracious reader throughout life. he often accompanied his father on medical rounds in the countryside. on these trips, he encountered the kahunas, the shamans who could put spells on people that actually resulted in death.3 he would remember this phenomenon when he began to investigate why his patients had symptoms for which he could find no medical cause. one day, his father had to operate on a field worker who had lost his hand. the operating theater was the front lawn of the alvarez house, and the operating table came from the kitchen.3 walter assisted in the surgery—at age 7. he credits those experiences with his decision to become a doctor.2 after 8 years in oahu, the family moved to honolulu, where walter’s father ran a new experimental hospital for treating leprosy.2,12 in honolulu, walter had access to better schools. still, much of his education came from extensive reading on a wide variety of topics in the local library.3 after graduating from high school in hawaii in 1901, walter returned to san francisco, where he enrolled in cooper medical college (later to become the stanford university school of medicine).2,13 he was only 17, but at that time, medical schools required only a high school education to matriculate.3 private practice walter began his internship and his research career in a san francisco hospital in 1906 (he was there for the great earthquake). in his first published article, he confirmed the recent discovery of treponema pallidum as the cause of syphilis.14 some 25 causes of syphilis had been proposed, so his diagnostic confirmation of t. pallidum was important. the article was published in the journal of the american medical association when he was just 22 years old. in the early 1900s, patients were routinely “purged” with laxatives before surgery to clear their bowels, even though the process weakened and dehydrated them. when no one could tell him why purging was done, he spent weeks in the library researching the practice. he concluded that its origins were the cleansing rituals that many preliterate cultures used to prepare someone for an ordeal, such as an initiation rite. he also found no evidence that it was effective. in one of his earliest publications, he made the case that purging was harmful and should be stopped.15 the article is credited with reducing the practice worldwide.2 walter married harriet skidmore smythe in 1907.16 later that year, their first daughter, gladys, was born,17 and walter took over his father’s medical practice, which was now in a remote mining camp in cananea, mexico (figure).18 as in hawaii, he was again living among indigenous people who held different beliefs about health, sickness, and healing. when he noticed that many of his patients expressed strong emotional reactions and exaggerated symptoms that seemed unrelated to organic causes, he made a point to spend time with the local curanderos, or traditional healers, learning how they understood and treated their patients. with this understanding, he could provide better medical care by helping patients suspend prescribed cultural reactions: “i can’t listen to your heartbeat if you continue to wail.” his patients could now stop the expected wailing because “the doctor said so.”3 after 2 years, however, he was ready to return to san francisco and so accepted an offer to open a practice with his former teacher and mentor, a gastroenterologist named dr schmoll.2 their practice soon became the most prestigious in the region (according to walter, perhaps with understatement, because they were so successful in treating millionaires for gout and in diagnosing syphilis with the new wassermann test).2 during this period, he began taking notes on his patients who reported abdominal pain or discomfort but in whom he could find nothing physically wrong. other physicians had given these patients an undefined diagnosis of “autointoxication” and often put them through one or more exploratory surgeries. walter remembered the kahunas and the curanderos. he was also aware that “confession of a sin made to a physician can be just as effective…as a confession made to a priest,” and noticed that abdominal symptoms often disappeared when patients resolved some issues in their lives. in 1912, he gave his first lecture on what later would be called psychosomatic medicine, and he continued to investigate this mind-body relationship throughout his career.2 walter was a gifted diagnostician. without modern testing, physicians actually had to look at and listen to their patients, and the best physicians were masters of careful observation. to show interns how important this skill was, walter interpreted a chest radiograph picked at random. his observations: the biography figure. walter clement alvarez, age 23. used with permission of mayo foundation for medical education and research 166 amwa journal / v36 n4 / 2021 / amwa.org radiograph was of a woman about 50 years old, who was tall, slender, and frail. she was catholic and had had several children. she had had tuberculosis and possibly a mild case of polio as a child and, at some point, pneumonia. she probably had high blood pressure, arteriosclerosis, and arthritis. finally, she quite likely hunted pheasants with her husband or brother and had been thrown from a horse. (his explanations for each observation are in his autobiography.2 sherlock holmes, move over.) during this time, he learned one of his little “diagnostic tricks”: “when you can’t identify the cause of a patient’s discomfort, ask the spouse.” (!) after 3 years, dr schmoll’s mental health began to decline (he was eventually institutionalized), and walter left the practice. in 1912, he accepted a position at harvard university, working with dr cannon, a renowned gastroenterologist, researching the anatomy and physiology of the bowel (ok, he studied flatulence in rabbits. but the research was far more important than the subject implies).12 during this period, walter also introduced the term “irritable bowel syndrome.”19 while in boston, walter decided he needed access to a broader range of the scientific literature. already fluent in english, spanish, and french, he could also understand italian from his study of latin, but he could not read german. so, for the next 4 years, he studied until he could easily read technical articles in german.2 (this period coincided with wwi, but his studies were unrelated to the war. walter does not mention either wwi or wwii in his biographies.) walter explained his enthusiasm for learning by citing the greek origins of the word: en-theos, the “god within.”3 this drive to expand his knowledge was lifelong. when insulin was discovered, he visited the canadian scientists, drs banting and best, who had discovered it. he made a point to meet sir alexander fleming, the discoverer of penicillin, and when he became frustrated at how to care for his gay and trans patients, he sought out dr alfred kinsey, the pioneer in research on sexuality and gender issues.3 when the family returned to san francisco in 1915, in addition to gladys, they had 3 more children: luis (1911), robert (1913), and bernice (1915).20 back in san francisco, walter ran a highly successful medical practice from 1915 to 1925, spending a half day at his office and the other half conducting research at the university of california, berkeley.2,18 although he was primarily a clinician, by 1919, his reputation as a basic researcher led to his election to membership in the american physiological society, the society for experimental biology and medicine, the american society for pharmacology and experimental therapeutics, the american society for clinical investigation, and the american roentgen ray society.13 also, in 1919, he turned his full attention to statistics,21 which he regarded as essential for doing research. later, he was instrumental in establishing the statistics department at mayo clinic.2 walter eventually parted ways with other physicians in the san francisco county medical association over their opposition to “much-needed workman’s compensation laws” and was looking for a new opportunity. as luck would have it, at a conference, he sat next to a member of the board of directors of mayo clinic, who immediately offered him a position at the clinic, which he took in 1926.2 his career at mayo clinic at mayo clinic, walter got his wish: he could continue his research, see patients, and support his family. eventually, his worldwide reputation as both a researcher and a clinician in gastroenterology led to his presidency of the american gastroenterological association in 1928.2 from 1937 until he retired from mayo clinic in 1951, he was also editor-in-chief of the american journal of digestive diseases, which later became gastroenterology.22 walter was an early advocate of health education.21 in 1932, he proposed that the clinic create a museum of medicine to help patients and the public understand the human body and its ailments and treatments. the museum continues today as mayo clinic heritage hall. in his second autobiography, he recalls that “two of my most grateful patients were notorious gangsters, who, strange to say, i came to like.” one, “a well-known citizen of chicago” from whom walter removed a painful gallstone, begged walter to “commit some crime so that through his friends he could ‘get me off.’” the other kept asking if there wasn’t someone walter wanted “bumped off,” which would be done without charge! in his 25 years at mayo clinic, walter published nearly 350 scientific articles.21 several times, he ran afoul of the young editors in the division of publications run by the legendary maud mellish. he tells about how they tried to make his writing more scientific by using more technical terms, such as replacing “hiccup” with “singultus,” and adhering to arcane rules of grammar when he wanted to write less formally. they also wanted to soften some of his more challenging conclusions. “fortunately for me…the editors-in-chief maud mellish and later richard hewitt always came to my rescue; they chased away the young ladies with the blue pencils…”2 (dr hewitt was president of amwa in 1955.) retirement, sort of in 1950, walter turned 65, retired from mayo clinic, and moved to chicago. within 6 months, however, he agreed to be the editor-in-chief of geriatrics and modern medicine and would remain so until he retired again, 25 years later, at age 90. biography amwa journal / v36 n4 / 2021 / amwa.org 167 walter continued to write after he retired. as a journal editor, he had written hundreds of editorials. in chicago, he continued this practice as a newspaper columnist, gaining fame as “america's family doctor” for his practical and understandable columns on personal health.23 his columns were soon syndicated in hundreds of daily and weekly newspapers throughout north america and in several countries.17,24 these columns, the 17 books he published during this period, and his “reassuring clinical wisdom and compassion” made him a beloved and world-famous physician.25 in his editorial office in chicago, walter hired a young woman just out of college to become his editorial assistant. kelley williams would spend the next 14 years editing his writings, producing weekly syndicated television and radio programs, and helping to coordinate his many professional activities and lectures at scientific conferences. she even suggested the wonderful title for his first autobiography, the incurable physician. walter, in turn, mentored her in medical writing and broadened her understanding of medicine and of life. in 1987, kelley became president of amwa, where she helped develop the core curriculum that was the backbone of the association for many years (kelley williams, personal communication, june 28, 2020). walter wrote on a wide range of topics, among them, the use of a psychological evaluation when diagnosing illness, the use and misuse of tranquilizers, the use of hypnosis in treating asthma, the activity of obese girls, the effects of glue-sniffing in children, office treatment of behavior disorders, depression, psychotherapy, sleep disturbances, and suicide. during this period, he became the most widely read and respected physician of the 20th century. at the peak of his activities, he had 12 million readers24 and received more than 100,000 letters a year asking for medical advice.2 his books and editorials in modern medicine and geriatrics were enjoyed by thousands of physicians. throughout his professional life, walter was interested in the genetic determinants of disease, especially psychiatric disorders (box 1). in part, his interest stemmed from his colleagues who did not routinely take thorough family histories of their patients and so missed many diagnoses. also, in the early 1900s, the “nature vs nurture” debate was in full swing, and “nurture” was more popular among some physicians, who were quick to blame parents for the mental health issues of their children. (one section of walter’s essay on heredity is titled “the taboo against even mentioning heredity.”2) walter believed he never adequately understood his patients who had questions or concerns about their sexual lives or gender identity. medical schools seldom addressed the topic, which was considered taboo and was accompanied by much incorrect information. walter did what he always did in such cases: he sought the best information he could find. he became good friends with dr alfred kinsey, who had just completed his landmark surveys, sexual behavior in the human male and sexual behavior in the human female. (kinsey’s research was funded in part by the rockefeller foundation, where the research department was headed by dr alan gregg, for many years a prominent member of amwa.) walter accepted the variety of gender identities as natural differences, not as moral failings to be punished or “cured,” and had great sympathy for his patients and the fear, guilt, anxiety, and discrimination they experienced.26 he sought to educate his colleagues and the public on the natural biological realities and on the unjust social consequences of sex and gender identity (kelley williams, personal communication, june 28, 2020). his legacy in 1975, walter retired for the second time. his wife had died in 1973, and he eventually moved back to san francisco to be with his children and grandchildren. he died there in 1978, but not before hiring yet another editorial assistant and writing until his death (kelley williams, personal communication, june 28, 2020). walter kept a diary for most of his life. before writing the incurable physician (published in 1963),2 he read all 62 volumes of the diary to prepare. he published 2 autobiographies, in 19632 and 1976.3 the biographies include many of his editorials.27 his second autobiography is filled with stories and anecdotes from his practice of medicine, which makes it quite engaging (box 2 on next page). the stories make it clear that although “many physicians treat diseases, alvarez treats people who have diseases.”23 box 1. early in his career, walter became interested in genetics and the effects of heredity on health. he relates a story told to him by an elderly doctor who had attended walter’s lecture on the topic. a census taker had knocked on the door of a shack in the course of his duties, and the door was opened by a girl who appeared to have a developmental disability but was nevertheless able to communicate. when the man asked if her father was in, she replied, “naw, he’s in the penitentiary.” when he asked if her mother was in, she replied, “naw, she’s in the state hospital.” asked if she had a sister, she said, “yeah, she works in the red-light district.” did she have a brother? “yeah, he’s at harvard medical school.” the man, stunned, said, “you mean your brother is a harvard professor? “naw,” she said. “he’s no professor. he has two heads; he’s in a bottle of alcohol.” biography 168 amwa journal / v36 n4 / 2021 / amwa.org biography for his achievements in educating the public about health and disease, amwa created the walter c. alvarez memorial award in 1982 to “honor excellence in communicating health care developments and concepts to the public.”28 walter’s last column, written 4 years before his death at age 94, was titled “the folly of retirement at age 65.”29 he clearly knew of what he spoke. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: tomlangcom@aol.com references 1. walter c. alvarez. wikipedia website. accessed june 2, 2020. https:// en.wikipedia.org/wiki/walter_c._alvarez 2. alvarez w. the incurable physician: an autobiography of dr. walter c. alvarez. prentice hall, inc; 1963. 3. alvarez w. alvarez on alvarez. strawberry hill press; 1977. 4. luis f. alvarez biography, fact, career, net worth and life story. accessed august 22, 2021. https://en.wikipedia.org/wiki/luis_f._alvarez 5. alvarez l. a new method of bacteriological diagnosis of leprosy. cited in lew j, chung m. the bacteriologic diagnosis of early leprosy by the trypsin digestion method. int j leprosy. 1959;27:360-365. pmid 14416455 6. forbes d. encounters with paradise: views of hawaii and its people, 1778-1941. university of hawaii press; 1992. 7. mabel alvarez biography. the annex galleries website. accessed august 22, 2021. https://www.annexgalleries.com/artists/biography/ 39/alvarez/mabel 8. luis walter alvarez. encyclopedia.com website. accessed june 24, 2020. https://www.encyclopedia.com/people/science-and-technology/ physics-biographies/luis-walter-alvarez 9. walter alvarez. wikipedia website. accessed june 22, 2020. https:// en.wikipedia.org/wiki/walter_alvarez 10. pope k, d’hondy s, marshall c. meteorite impact and the mass extinction of species at the cretaceous/tertiary boundary. proc natl acad sci usa. 1998;95(19):11028-11029. 11. harmon k. a theory set in stone: an asteroid killed the dinosaurs, after all. scientific american website. published march 10, 2010. accessed june 15, 2020. https://www.scientificamerican.com/article/asteroidkilled-dinosaurs/ 12. luis f. álvarez. wikipedia website. accessed june 3, 2020. https:// en.wikipedia.org/wiki/luis_f._alvarez 13. fordtran j, goyal r, feldman m, et al. gastroenterology’s editorsin-chief: historical and personal perspectives of their editorships. gastroenterology. 2013;145:16-31. 14. alvarez w. the spirochæta pallida (treponema pallidum) in syphilis. jama. 1906;xlvi(22):1687-1690. 15. alvarez wc. is the purgation of patients before operation justifiable? surg gynecol obstet. 1918;26:651-659. 16. doctor walter alvarez, writer, dies. santa cruz sentinel. june 20, 1978:24. 17. walter clement alvarez (1884-1978). wikitree website. accessed may 12, 2020. https://www.wikitree.com/wiki/alvarez-1582 18. saxon w. dr. walter c. alvarez, 93, dies; had been mayo clinic specialist. new york times. june 20, 1978. 19. camilleri m. irritable bowel syndrome: how useful is the term and the ‘diagnosis’? therap adv gastroenterol. 2012;5(6):381-386. 20. dr walter clement alvarez. familysearch website. accessed june 7, 2020. https://ancestors.familysearch.org/en/lvf4-tt3/dr-walterclement-alvarez-1884-1978 21. nelson cw. early mayo medical illustrating. mayo clin proc. 1995;70(8):724. 22. a brief history of the journal and its editors. gastroenterology. 1968;54(4):suppl:693-696. 23. garwin r. memorial tribute for luis w. alvarez. in memorial tributes, national academy of engineering, volume 5. national academy press; 1992. 24. mehan m. walter c. alvarez: american man of medicine. jama. 1997;237(18):1987-1988. 25. a brief biography – yousuf karsh. yousuf karsh website. accessed june 2, 2020. https://karsh.org/a-brief-biography/ 26. alvarez w, martin s. homosexuality vs. gay liberation and other forms of sexual deviance. pyramid books; 1974. 27. alvarez w. walter c. alvarez: american man of medicine. van nostrand reinhold company; 1976. 28. recognition. american medical writers association website. accessed may 2, 2020. https://www.amwa.org/page/recognition 29. alvarez w. editorial: the folly of retirement at age 65. geriatrics. 1974;29(10):153. box 2. walter tells a story about why physicians shouldn’t jump to conclusions about their patients. one of his patients, a woman, was told by another doctor that her poor health was caused by not having children. “i know your type well. you doll yourself up in the morning, play cards in the afternoon, and live a stupid, indoor existence.” later, she told walter that “i didn’t bother to tell him that my husband smuggles whisky across the canadian border. most nights i sit in the car with him, watching out for hijackers, with a submachine gun across my lap.” mailto:tomlangcom@aol.com https://en.wikipedia.org/wiki/walter_c._alvarez https://en.wikipedia.org/wiki/walter_c._alvarez https://en.wikipedia.org/wiki/luis_f._alvarez https://www.annexgalleries.com/artists/biography/39/alvarez/mabel https://www.encyclopedia.com/people/science-and-technology/physics-biographies/luis-walter-alvarez https://en.wikipedia.org/wiki/walter_alvarez https://en.wikipedia.org/wiki/walter_alvarez https://www.scientificamerican.com/article/asteroid-killed-dinosaurs/ https://www.scientificamerican.com/article/asteroid-killed-dinosaurs/ https://www.scientificamerican.com/article/asteroid-killed-dinosaurs/ https://en.wikipedia.org/wiki/luis_f._alvarez https://en.wikipedia.org/wiki/luis_f._alvarez https://www.wikitree.com/wiki/alvarez-1582 https://ancestors.familysearch.org/en/lvf4-tt3/dr-walter-clement-alvarez-1884-1978 https://ancestors.familysearch.org/en/lvf4-tt3/dr-walter-clement-alvarez-1884-1978 https://ancestors.familysearch.org/en/lvf4-tt3/dr-walter-clement-alvarez-1884-1978 https://karsh.org/a-brief-biography/ https://www.amwa.org/page/recognition v37 n2 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 46 the walter c. alvarez award is named in honor of walter c. alvarez, md, a pioneer in the field of medical communication. the award is presented to either a member or nonmember of amwa to honor excellence in communicating health care developments and concepts to the public. the alvarez award is presented during amwa's medical writing & communication conference. the 2022 walter c. alvarez award is presented to dr leana wen in honor of her many contributions in health communication, including regular columns in the washington post, the patient advocacy book when doctors don’t listen: how to avoid misdiagnoses and unnecessary tests, and the memoir of her career in public health, lifelines: a doctor’s journey in the fight for public health. she has also authored dozens of articles in scientific publications including health affairs, lancet, plos medicine, and the american journal of public health. during the covid-19 pandemic, dr wen served as a cnn medical analyst and anchored a new washington post newsletter “the checkup with dr wen” to provide help on navigating this and other public health challenges. as a consistent voice for using scientific evidence to guide policy decisions, these columns have aided many in understanding the numerous changes to guidelines and requirements. she brought this expertise to congress in june 2020, testifying in front of the in front of the us house of representatives select subcommittee on the coronavirus crisis on racial disparities and covid-19. dr wen’s career has focused on public health as a fundamental force in our individual lives and well-being. previously, she served as baltimore's health commissioner, where she led the nation’s oldest continuously operating health department in the united states to fight the opioid epidemic, treat violence and racism as public health issues, and improve maternal and child health. she directed the public health recovery efforts of baltimore after the 2015 riots, working to ensure access to prescription medication after pharmacy closures and working to develop the city’s mental health and trauma recovery plan with crisis counseling, youth health and wellness, and violence prevention programs. as she states in lifelines, “public health saved your life today—you just don’t know it.” as an expert on patient advocacy and patient-centered care, dr wen has long encouraged transparency in medicine. she began this work during in medical school, serving as the national president of the american medical student association and leading campaigns to decrease health disparities and combat conflicts of interest between physicians and pharmaceutical companies. she has campaigned for voluntary disclosure of such conflicts of interest, and her ted talk on this topic has been viewed over 2 million times. dr wen obtained her medical degree from washington university school of medicine and studied health policy at the university of oxford, where she was a rhodes scholar. she completed her residency training at brigham and women's hospital and massachusetts general hospital, where she was a clinical fellow at harvard medical school. dr wen currently works as an emergency physician, professor of health policy and management at george washington university, and a nonresident senior fellow at the brookings institution. she lives with her husband and their 2 young children in baltimore. kimberly korwek, phd / chair, annual conference program committee 2022 walter c. alvarez award recipient: dr leana wen amwa news http://www.amwajournal.org v37 n2 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 43 as treasurer for the american medical writers association (amwa), i am providing a financial report for the 2020-2021 fiscal year which ended june 30, 2021. amwa continued to experience the impact of the pandemic during this year. staff transitioned back to working in the office on a part-time basis; however, in-person meetings and travel did not resume. amwa held its firstever virtual conference that was very successful and well received. in addition, several staff positions were unfilled during this time. amwa also obtained a second round of funding from the small business administration payroll protection plan (ppp) loan to help retain staff and keep major programs running. amwa successfully applied for and was granted forgiveness of the first and second rounds of ppp funding. financial performance amwa’s net income for the 2020-2021 fiscal year was $837,466 with significant investment gains and grant income from the ppp loan forgiveness contributing to these positive results. revenues overall, program revenues exceeded budget expectations by 16%. this was largely because of the conservative income budget estimates that were used due to the uncertainty surrounding the pandemic. membership, annual conference, and education/certificate program income continue to be amwa’s major sources of revenue, providing 86% of amwa’s program revenue. net investment income, shown in figure 1 in all other revenue, of $115,074 accounted for 5% of amwa’s total revenue. expenses amwa invests in programs, products, and services that bring value to members and the medical writing community. overall, program expenses were under budget by 15% for the fiscal year. total program expenses for the fiscal year were $1,373,546, with 31% of the expenses being used to fund membership benefits, 17% of expenses were used to produce the virtual annual conference, 21% of expenses funded educational programs including the essential skills certificate program and online education, and 8% was used to produce the journal (figure 2). reserves reserves are the accumulation of funds over time that enable an organization to withstand an emergency or to invest in new mission-related initiatives. unrestricted reserves of 6 to 12 months of annual operating expenses represent a standard target for not-for-profit organizations. with budgeted annual operating expenses of $1,678,950 for the fiscal year from july 1, 2021, to june 30, 2022, the target for amwa’s reserves ranges from $800,000 to $1,600,000. amwa’s unrestricted shortand long-term investment reserve level of $2,526,739 on june 30, 2021, exceeds this targeted range. julie phelan, md, mba / 2020-2021 amwa treasurer amwa annual financial report, 2020-2021 amwa news figure 1. sources of program revenue for the fiscal year that ended june 30, 2021. figure 2. sources of major program expenses for the fiscal year that ended june 30, 2021. http://www.amwajournal.org amwajournal.org 44amwa annual financial report, 2020-2021 amwa’s restricted endowment and mcgovern funds totaled $246,612 and $199,665, respectively. financial position an organization’s financial position is reflected in its asset and liability holdings. amwa is well positioned to pay its obligations and plan for the future. total assets were $4,137,522 as of june 30, 2021, and the organization’s liabilities totaled $701,598. financial statement audit results abercrombie and associates, amwa’s independent auditors, expressed an unqualified opinion regarding their audit of the financial statements for the fiscal year that ended june 30, 2021. an unqualified opinion states that the financial statements present fairly in all material respects, an entity's financial position, results of operations, and cash flows in conformity with generally accepted accounting principles. amwa continues to be in a secure financial position as it continues expanding member benefits and resources into the next fiscal year. the full audit report is available to amwa members upon request. acknowlegment i thank calibre cpa group, pllc, for providing the financial data, and the members of the 2020-2021 budget and finance committee for their review of reports and budgets: june baldwin, adriana caballero, alice pappas, leena patel, whitney smalley-freed, and christine wogan (as well as ex officio members gail v. flores [2020-2021 amwa president], katrina r. burton [amwa president-elect], and susan krug [amwa executive director]). author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: julie@biomedisysinc.com get fit with amwa f ast i nteractive t raining amwa’s fit series helps medical communicators stay healthy. in only 15 minutes—jog your memory, tone your writing muscles, build your core skills, and stretch your knowledge. www.amwa.org/fit only $15 each / approved for .5 ce topics in the series include: } misplaced modifiers } mean, median, and mode } dangling participles } measures of variability http://www.amwajournal.org 64 amwa journal / v36 n2 / 2021 / amwa.org abstract the coronavirus disease 2019 (covid-19) pandemic has necessitated that medical writers adapt their work practices quickly to assist with the preparation of documentation related to covid-19 research and clinical trials, as well as to assess the impact of the pandemic on other clinical trials. complexities and challenges medical writers have faced include the growing scientific knowledge of the virus, the burgeoning global footprint of the pandemic, and the evolving regulatory landscape on both covid-19 and non-covid-19 clinical trials. introduction when cases of a novel coronavirus, severe acute respiratory syndrome coronavirus 2 (sars-cov-2), surfaced in the hubei province of china in december 2019, leading to the outbreak of a complex respiratory illness (later coined coronavirus disease 2019 [covid-19]), the world watched to see what would happen next. many were cautiously optimistic that the virus would remain endemic to the region of the outbreak, as middle east respiratory syndrome (mers) had in 2012,1 or, at worst, that it could be contained as the severe acute respiratory syndrome (sars) epidemic had been in 2003.2 the challenge of trying to contain the novel coronavirus was complicated by a lack of clarity on exactly how it was transmitted3; it was not until january 19, 2020, that the world health organization (who) announced that there was evidence of human-tohuman transmission of the virus.4 this article provides a brief overview of the covid-19 pandemic time course, the regulatory actions taken to allow for unprecedented rapid development of diagnostic and therapeutic products in the united states for covid-19, and the impact of the pandemic on medical writers in the biotech and pharmaceutical industry. arrival of covid-19 in the united states and initial impact on biotech and pharmaceutical companies a recent retrospective analysis of sars-cov-2–reactive antibodies in archived blood donation samples, spanning 9 states from the east to west coasts, indicates that covid-19 may have been widely introduced into the united states as early as mid-december 2019.5 despite the first cases of covid-19 being observed in the united states and europe on january 19 and 24, 2020, respectively (figure),4,6 operations for biotech and pharmaceutical companies in the united states continued as normal into february. on february 26 and 27, a large conference was hosted by a biotech company in boston, massachusetts, which was later deemed a “superspreader” event,7 with approximately 100 diagnosed cases after the event ultimately being associated by genomic analysis with up to 330,000 subsequent cases. following this event, biotech and pharmaceutical companies across the united states, particularly those in states experiencing a surge in cases, began enacting business continuity plans per local and state guidelines, including sheltering in place to the extent possible. meanwhile, a shortage of personal protective equipment led many companies to donate their current laboratory supplies to local health care centers in surge states in early spring.8 for those employees who did have to go on site at their companies to perform experiments, a lack of covid-19 testing supplies contributed to uncertainty for how to continue critical research while minimizing the risk for virus spread. with guidelines on safe business operation being issued at the state level, it was not immediately clear how planned research and development (r&d) activities would be impacted or for how long. to address local social distancing requirements, some companies had to prioritize laboratory research for covid-19 and for certain conditions with unmet need.9 it was also not immediately clear to what extent biotech and pharmaceutical companies, and the venture capital firms that finance their r&d activities, would invest in developing treatjeanette towles, ma / synterex, inc., boston, ma a brief history of the covid-19 pandemic and current efforts to combat it r e s e a r c h amwa journal / v36 n2 / 2021 / amwa.org 65 ments for a novel virus that might not persist in the long term, based on evolving information on sars-cov-2 as well as prior sars/mers experience. these factors represented an initial threat to an industry that is largely dependent upon the continuous advancement of research. declaration of a pandemic, the us food and drug administration response, and the shift to realtime drug development pursuant to a rise in the number, severity, and location of cases, a pandemic was formally declared on march 11, 2020, by who.10 the director of who urged countries worldwide to change the course of the pandemic and to “first, prepare and be ready. second, detect, protect and treat. third, reduce transmission. fourth, innovate and learn.” as more became known publicly about the clinical course of the virus, many global biotech and pharmaceutical companies sprang into action to see if existing technology or assets could contribute to a cure or a treatment for covid-19 or its sequelae. these companies included those already developing vaccines, those developing therapeutics who entered vaccine development de novo, those repurposing existing antiviral and other drugs, and those developing new drugs. several companies partnered with other biotech companies or academic institutions to optimize efficiency. the sequence of the virus was first made public in early january 2020,4,11 and by late january, the us food and drug administration (fda) announced that it was “actively leveraging the vast breadth of the fda’s expertise” and had “begun employing the full range of our public health authorities to facilitate the development and availability of investigational medical products to help address this urgent public health situation.”12 on january 31, 2020, the us department of health and human services declared that covid-19 constituted a us public health emergency and that an emergency use authorization (eua) was needed to mitigate the threat of covid-19. this action enabled the fda, in consultation with the national institutes of health and centers for disease control and prevention (cdc), to authorize the emergency use of unapproved medical products (table 1).13,14 with so many companies advancing new covid-19 pipeline assets, many of the biotech and pharmaceutical employees who were initially impacted by the halt of other clinical trials eventually were reassigned to covid-19–related work.9 first case of “viral pneumonia” reported in wuhan, china sars-cov-2 virus genomic sequence published and made public via who; 1st death from covid-19 reported in china 1st vaccine vrbpacs and euas who convenes diagnostics/ laboratories global expert network, announces protocol for rt-pcr for covid-19 diagnostic; 1st and 2nd cases reported outside of china in thailand and japan, respectively 1st covid-19 case reported in us; 1st case reported in eu; guidance on mask-wearing in public released by who 1st diagnostic rt-pcr tests available, 1st diagnostic eua in us; virus coined “covid-19” by who who declares covid-19 pandemic eua for hq/cq issued by us fda, ows launches, ctap announced eua for hq/cq revoked; fda issues guidance on vaccine development eua for remdesivir issued by us fda (severe covid/ hospitalized patients); fda issues guidance on covid trials fda issues guidance on conducting clinical trials during pandemic, announces suspension of domestic and foreign routine and bimo inspections eua issued for convalescent plasma; fda issues guidance on supply chain and inspections; eua for remdesivir broadened euas issued for 3 mabs fda announces plans to resume domestic inspections; eua issued for 1st covid testing of asymptomatic individuals nih announces activ program fda issues eua guidance for vaccines; approval of remdesivir for covid-19 treatment dec 2020 nov 2020 oct 2020 aug 2020 jul 2020 jun 2020 may 2020 apr 2020 mar 2020 feb 2020 jan 2020 31 dec 2019 figure. timeline of key events associated with the covid-19 pandemic. sources: who,3,4,10 genbank,11 fda.15,18-22,24,33,47-49 abbreviations: activ, accelerating covid-19 therapeutic interventions and vaccines; bimo, biomedical research monitoring; covid-19, novel coronavirus 2019; cq, chloroquine; ctap, coronavirus treatment acceleration program; eu, european union; eua, emergency use authorization; fda, food and drug administration; hq, hydroxychloroquine; mab, monoclonal antibody; nih, national institutes of health; ows, operation warp speed; rt, reverse transcription polymerase chain reaction; sars-cov-2, virus that causes coronavirus 2019 disease; us, united states; vrbpac, vaccines and related biological products advisory committee; who, world health organization. 66 amwa journal / v36 n2 / 2021 / amwa.org as the author experienced, and based on personal communication of the author with industry colleagues, medical writers set to work alongside researchers on manuscripts for covid19 research, many times resulting in unprecedented rapid review and release of results in journals ahead of peer review to allow for real-time dissemination. regulatory medical writers collaborated with cross-functional colleagues on investigational new drug (ind) application and eua documentation to enable clinical evaluation of diagnostic, therapeutic, and preventive products; others participated in conversations with contract research organizations (cro) and sites, balancing operational feasibility and cost while implementing evolving regulatory guidance, to determine if certain non-covid-19 trials would be able to continue during the pandemic. although medical writers have connected with colleagues remotely via various electronic media for a long time, many recently have had to cope with a new shift in their workload and priorities. in addition, medical writers have had to change how and how often they communicate during the writing process to meet the demand of real-time drug development, oftentimes working in coauthoring environments or live meetings rather than iteratively. table 1. global and united states covid-19 preventive and therapeutic initiatives initiative owner(s) initiative purpose various governments, scientists, businesses, civil societies, philanthropists, and global health organizations the act accelerator global collaboration to accelerate the development, production, and equitable access to covid-19 tests, treatments, and vaccines.38,39,a who + global experts r&d blueprint a global strategy and preparedness plan to fast-track the availability of effective tests, vaccines, and medicines that can be used to save lives and avert large-scale crises. global research roadmap released in march 2020.40,41 who solidarity ii international clinical trial25,b covid-19 technical guidance: the unity studies: early investigation protocols global collaboration led by who that promotes the implementation of serological surveys of sars-cov-2. promotes standardized epidemiological, molecular, and serological methods to facilitate international comparisons so that both countries and the global community can collectively address knowledge gaps and inform an evidence-based covid-19 response.42 us dhhs ows partnership among components of the dhhs, including the cdc, nih, barda, and dod with private firms and other federal agencies. coordinates existing dhhs-wide efforts, including the nih’s activ partnership, nih’s radx initiative, and work by barda. vaccine candidates from 3 companies are part of this initiative.43 fnih activ public-private partnership to speed covid-19 vaccine and treatment options.44 us dhhs, nih covpn merged 4 existing niaid-funded clinical trials networks: the hiv vaccine trials network, hiv prevention trials network, infectious diseases clinical research consortium, and aids clinical trials group.45 us dhhs, fda ctap special emergency program for possible covid-19 therapies.46 provides fda subject matter expertise for activ initiatives, including for clinical trial design/conduct and regulatory standards. act, access to covid-19 tools; activ, accelerating covid-19 therapeutic interventions and vaccines; aids, acquired immunodeficiency syndrome; barda, biomedical advanced research and development authority; covpn, covid-19 prevention trials network; ctap, coronavirus treatment acceleration program; dhhs, department of health and human services; dod, department of defense; fnih, foundation of the national institutes of health; hiv, human immunodeficiency virus; niaid, national institute of allergy and infectious diseases; nih, national institutes of health; ows, operation warp speed; radx, rapid acceleration of diagnostics. acovax is the vaccines pillar of the act accelerator. more information on the nonvaccine pillars of the act accelerator is available at https://www.who.int/initiatives/ act-accelerator. on december 31, 2020, the first vaccine received emergency use validation from who.39 bthe results of the solidarity i adaptive treatment trial became available october 15, 2020, and concluded that the 4 treatments studied (remdesivir, hydroxychloroquine, lopinavir/ritonavir, and interferon) had little or no effect compared with standard of care on overall mortality, initiation of ventilation, and duration of hospital stay in hospitalized patients. additional agents to be evaluated per who. https://www.who.int/initiatives/act-accelerator amwa journal / v36 n2 / 2021 / amwa.org 67 diagnostics and medical equipment for covid-19 under eua in early february 2020, the first eua for a reverse transcription polymerase chain reaction covid-19 diagnostic was issued for use at cdc laboratories.15 emergency use authorizations were also subsequently issued for equipment needed to protect health care workers and treat patients with covid-19 as well as for additional diagnostics at non-cdc laboratories that would reduce the time to and accuracy of results, including home testing kits most recently.13,16 the issuance of fda guidance on diagnostic testing in may 202016 enabled the subsequent availability of additional testing options (for example, rapid antigen testing). upon availability of such testing options, medical writers began incorporating covid-19 testing strategies into study protocols and amendments, with built-in flexibility in language to allow for regional differences in testing availability or adoption of cdc recommendations—a critical step toward the restart of early-phase trials, which often have an in-residence component at the phase 1 unit. preventive and therapeutic products, including vaccines, for covid-19 under eua the writing of clinical trial protocols for covid-19 studies began in the context of the burgeoning geographic footprint of the pandemic, with health care centers in some regions too overwhelmed by critically ill patients to contribute to research while simultaneously in dire need of experimental treatments, leading to an added layer of volatility in an already dynamic process. accordingly, regulatory advice on the conduct of such studies developed over time. medical writers worked in concert with their cross-functional partners, regulators, and other stakeholders to overcome these challenges and produce protocols for evaluation of a novel virus and to interpret and convey the results of those studies in record time. the first eua for a covid-19 therapeutic was granted in march 2020 for antimalarial agents hydroxychloroquine and chloroquine (table 2).13 the fda issued several guidance documents in may 2020 toward expediting development of covid-19 products,17 including information on the process for initiating discussions with the fda (pre-ind)18 and study design recommendations, including patient selection, endpoints, and analyses.19,20 guidelines on vaccine development were issued the following month and updated in october and most recently in february of 2021 to outline the vaccine eua process.21,22 subsequent euas were granted for 9 additional products, including an antiviral in may, convalescent plasma in august, monoclonal antibody regimens in november, and the first vaccines in december 2020 (table 2).13,23 monitoring of previously issued euas continues and, in some cases, has led to the withdrawal of the eua, such as that which occurred for hydroxychloroquine and chloroquine upon analysis of conflicting data (including results from a randomized, controlled trial) that brought into question the benefit-risk profile of this regimen for treatment of covid-19.13,24,25 the eua issued for antiviral remdesivir in may led to approval of the drug as the first treatment for covid-19 under the coronavirus treatment acceleration program (see table 1) in october 2020. as of january 2021, a search on the us national library of medicine’s clinicaltrials.gov (search terms of covid-19 and sars-cov-2, with a recruitment status of not yet recruiting, recruiting, enrolling by invitation, active, or not recruiting) returns results for over 3,500 covid-19 clinical trials that are ongoing or in start-up.26 clinical trials during the covid-19 pandemic between approximately march and may 2020, thousands of clinical trials (or around 80% of non-covid-19 trials) reported a disruption,27-30 with the majority of these being early-phase trials that had not yet started enrolling patients.27,29 the most affected therapeutic areas included those enrolling participants with advanced or life-threatening conditions such as cardiovascular disease or oncology—indeed, the very patients who are most at risk for covid-1931—who often have few other treatment options; the typical intravenous administration route of oncologic treatments, which require patients to go to the clinical site for infusions, has led to additional logistical hurdles.29,32 disruptions were reported as delay or suspension in enrollment, delay in study start-up activities or initiation of certain sites, delay in dosing, termination of enrollment at specific sites, early trial termination, and delay in trial completion or availability of data.26,29 in many cases, clinical trials that were nearly or already fully enrolled in patient populations with life-threatening conditions continued with modifications to address the uncertainties and challenges of conducting clinical trials in an already burdened health care system.29 in march 2020, the fda issued guidance on the conduct of clinical trials during the covid-19 pandemic, with the goal of ensuring “the safety of trial participants, maintaining compliance with good clinical practice and minimizing risks to trial integrity.”33 the guidance has been updated on a regular basis and covers key topics, such as: • electronic and other remote informed consent options • alternative formats for visits (eg, phone contact, virtual visit, alternative locations, local laboratory or imaging centers, home nursing) • alternative formats for clinical outcome assessments (ie, patient-reported outcomes, clinician-reported outcomes, and observer-reported outcomes), including protection of data privacy 68 amwa journal / v36 n2 / 2021 / amwa.org table 2. covid-19 therapeutics and biological products approved under eua date of first eua issuance (reissuance, if applicable) approved product under eua therapy type authorized use march 29, 2021 janssen covid-19 vaccine recombinant, replicationincompetent human ad26 vectored vaccine encoding a stabilized variant of the sars-cov-2 s protein for the prevention of covid-19 for individuals ≥18 years old december 18, 2020 (reissued february 25, 2021) moderna covid-19 vaccine mrna vaccine for the prevention of covid-19 for individuals ≥18 years old december 11, 2020 (reissued february 25, 2021) pfizer-biontech covid-19 vaccine mrna vaccine for the prevention of covid-19 for individuals ≥16 years old february 09, 2021 (reissued february 25, 2021) bamlanivimab and etesevimab antibodies for the treatment of mild-to-moderate covid-19 in adult and pediatric patients with positive results of direct sars-cov-2 viral testing who are ≥12 years old, weigh at least 40 kg, and are at high risk for progressing to severe covid-19 and/or hospitalization november 21, 2020 (reissued february 25, 2021) casirivimab and imdevimab antibodies for the treatment of mild-to-moderate covid-19 in adults and pediatric patients (≥12 years old weighing ≥40 kg) with positive results of direct sars-cov-2 viral testing and who are at high risk for progressing to severe covid-19 and/or hospitalization november 19, 2020 baricitinib in combination with remdesivir antibody + antiviral for emergency use by health care providers for the treatment of suspected or laboratoryconfirmed covid-19 in hospitalized adults and pediatric patients ≥2 years of age requiring supplemental oxygen, invasive mechanical ventilation, or ecmo august 23, 2020 (reissued march 09, 2021) covid-19 convalescent plasma convalescent plasma for the treatment of hospitalized patients with covid-19 august 13, 2020 sodium chloride and sodium citrate renal replacement and regional solution for anticoagulation of the extracorporeal circuit replacement solution for crrt to be used as a replacement solution only in adult patients treated with crrt, and for whom regional citrate anticoagulation is appropriate, in a critical care setting may 8, 2020 propofol 2% sedative to maintain sedation via continuous infusion in patients >16 years old with suspected or confirmed covid-19 who require mechanical ventilation in an icu setting may 1, 2020 (reissued october 22, 2020)a remdesivir for certain hospitalized patients with covid-19 antiviral for emergency use by licensed health care providers for the treatment of suspected or laboratory-confirmed covid-19 in hospitalized pediatric patients weighing 3.5 kg to <40 kg or hospitalized pediatric patients <12 years old weighing at least 3.5 kg april 30, 2020 potassium-free and 2, 3, and 4 mmol/l potassium solution for hemodialysis/hemofiltration replacement solution for crrt to provide crrt to treat patients in an acute care environment during the covid-19 pandemic source: fda 2021.13 ad26, adenovirus serotype 26; crrt, continuous renal replacement therapy; ecmo, extracorporeal membrane oxygenation; icu, intensive care unit; mrna, messenger rna. athe original eua for remdesivir issued may 1, 2020, was for the treatment of suspected or laboratory-confirmed covid-19 in adult and pediatric patients hospitalized with severe disease. the eua was expanded to include adult and pediatric patients with covid-19 irrespective of severity on august 28, 2020. remdesivir was the first treatment to receive approval under coronavirus treatment acceleration program on october 22, 2020, for use in adults and pediatric patients with covid-19 who are ≥12 years old and weigh ≥40 kg requiring hospitalization; the eua was reissued to allow for continued access to a subset of hospitalized pediatric patients with suspected or laboratory-confirmed covid-19 who weigh 3.5 kg to <40 kg or who are <12 years old and weigh at least 3.5 kg. amwa journal / v36 n2 / 2021 / amwa.org 69 • supply chain considerations, such as direct-to-patient shipping, administration by a home nurse, and disposal of the investigational product • remote site monitoring considerations, including prioritization of monitoring activities in the circumstance of clinical trial site closures, infectious disease control restrictions, or local travel constraints • serious adverse event (sae) reporting, including reporting of cases of covid-19 on non-covid-19 clinical trials and cross-reporting of saes in the case of multiple inds a key takeaway of the guidance is to ensure collection of information on when and how any mitigations were implemented in a clinical trial to facilitate subsequent reporting on the impact of covid-19 on the trial objectives. in addition, the biotech and pharmaceutical industry has contributed to the discussion of clinical trial mitigations necessitated by covid-19. transcelerate biopharma, a collection of member biotech and pharmaceutical companies working to standardize key clinical trial activities, released a number of covid-19–related initiatives, including a data-sharing platform called datacelerate for covid-19 research, tools for riskbased monitoring and protocol deviation management, and a clinical study report template for outlining details on covid19–related clinical trial impact.34,35 with information changing regularly because of the dynamic nature of the pandemic and its regionally varied effects, and with ongoing updates from global health agencies, however, it is clear that any such tool will be a work in progress rather than a static guideline and that medical writers will need to stay informed on any updates over time. it is unclear as of yet what impact these mitigations have had on the overall continuation of non-covid-19 clinical trials during the pandemic. the success of the mitigations will need to be analyzed and reported on at an individual study level, depending on the company’s assessment of what measures were needed at the time the pandemic affected the trial, with any publications based on the trial footnoted accordingly with this context. based on regional variation on how the measures could be implemented, it is also possible that some mitigations will be successful in some regions but not others or that some mitigations were successful overall, whereas other planned mitigations were unsuccessful because of local circumstances. it is clear that properly contextualizing and reporting out the results of any such mitigations will be a time-consuming effort that requires complete source documentation and follow-up on details with cro and site partners. looking forward for medical writers, the pandemic has provided both opportunities, such as the opportunity to work on the surge of covid19–related clinical study protocols and manuscripts, and challenges, such as the interruption of some non-covid-19 studies or research and the need to work with urgency to produce communication for various purposes. as we pass the 1-year mark from when the first cases of covid-19 were reported, with the recent approval of vaccines, some aspects of the medical writing profession and the industry in general may start to return to normal. time will tell how biotech and pharmaceutical companies, which are reliant on raising capital for operational costs, will fare with the delay of important milestone reporting that helps raise those funds. trials of preventive and therapeutic products for covid-19 will continue, including those in nonhospitalized settings36 and in different age groups and populations; sequelae of covid-19 will also require treatment. viral mutations and their implications on available treatments and vaccines will require monitoring,37 and new waves of lockdowns may cause continued clinical trial enrollment and execution challenges as certain regions with increased case counts return to lockdown. it remains to be determined how some of the efficiencies gained during the pandemic will be applied as learning for future processes in a sustainable way. author declaration and disclosures: jeanette towles has received funds from several biotech and pharmaceutical companies for regulatory writing services on covid-19 clinical trials. author contact: jtowles@synterex.com references 1. middle east respiratory syndrome coronavirus (mers-cov). world health organization. published march 11, 2019. accessed december 6, 2020. https://www.who.int/news-room/fact-sheets/detail/middle-eastrespiratory-syndrome-coronavirus-(mers-cov) 2. severe acute respiratory syndrome 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prevent covid-19: guidance for industry. us food and drug administration. published february 22, 2021. accessed april 19, 2021. https://www.fda.gov/ media/142749/download 23. pfizer-biontech covid 19 vaccine. us food and drug administration. published december 11, 2020. accessed january 31, 2021. https://www. fda.gov/emergency-preparedness-and-response/coronavirus-disease2019-covid-19/pfizer-biontech-covid-19-vaccine 24. frequently asked questions on the revocation of the emergency use authorization for hydroxychloroquine sulfate and chloroquine phosphate. us food and drug administration. published june 19, 2020. accessed december 6, 2020. https://www.fda.gov/media/138946/ download 25. “solidarity” clinical trial for covid-19 treatments. world health organization. published 2020. accessed december 6, 2020. https:// www.who.int/emergencies/diseases/novel-coronavirus-2019/globalresearch-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-forcovid-19-treatments 26. clinicaltrials.gov. https://www.clinicaltrials.gov. accessed january 2, 2021. 27. fidler b. a guide to clinical trials disrupted by the coronavirus pandemic. biopharma dive. published may 15, 2020. accessed december 6, 2020. https://www.biopharmadive.com/news/ coronavirus-clinical-trial-disruption-biotech-pharma/574609/ 28. rees v. impact of covid-19 on clinical trials continuing, say researchers. european pharmaceutical review. published september 11, 2020. accessed january 2, 2021. https://www.europeanpharmaceuticalreview. com/news/128134/impact-of-covid-19-on-clinical-trials-continuingsay-researchers/ 29. van dorn a. covid-19 and readjusting clinical trials. lancet. 2020;396 (10250):523-524. 30. asaad m, habibullah nk, butler ce. the impact of covid-19 on clinical trials. ann surg. 2020;272(3):e222-e223. 31. certain medical conditions and risk for severe covid-19 illness. centers for disease control and prevention. published december 29, 2020. accessed january 2, 2021. https://www.cdc.gov/coronavirus/2019-ncov/ need-extra-precautions/people-with-medical-conditions.html 32. common questions about the covid-19 outbreak. american cancer society. published december 21, 2020. accessed january 2, 2021. https://www.cancer.org/latest-news/common-questions-about-thenew-coronavirus-outbreak.html 33. coronavirus (covid-19) update: fda issues guidance for conducting clinical trials. us food and drug administration. published march 18, 2020. accessed december 6, 2020. https://www.fda.gov/news-events/ press-announcements/coronavirus-covid-19-update-fda-issuesguidance-conducting-clinical-trials 34. covid-19. transcelerate biopharma, inc. accessed december 13, 2020. https://www.transceleratebiopharmainc.com/covid-19/ 35. clinical content & reuse solutions. clinical template suite (cts); template, resources, and use guidance: 2020 csr updates. csr considerations for studies disrupted by the covid-19 pandemic. transcelerate biopharma, inc. accessed december 13, 2020. https:// www.transceleratebiopharmainc.com/assets/clinical-content-reusesolutions/ 36. assessing covid-19-related symptoms in outpatient adult and adolescent subjects in clinical trials of drugs and biological products for covid-19 prevention or treatment: guidance for industry. us food and drug administration. published september 2020. accessed december 13, 2020. https://www.fda.gov/regulatory-information/searchfda-guidance-documents/assessing-covid-19-related-symptomsoutpatient-adult-and-adolescent-subjects-clinical-trials-drugs 37. interim: implications of the emerging sars-cov-2 variant voc 202012/01. centers for disease control and prevention. published https://www.the-scientist.com/bio-business/how-the-pharma-industry-pulled-off-the-pivot-to-covid-19-67719 https://www.the-scientist.com/bio-business/how-the-pharma-industry-pulled-off-the-pivot-to-covid-19-67719 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https://www.who.int/news/item/0312-2020-global-access-to-covid-19-vaccines-estimated-to-generateeconomic-benefits-of-at-least-153-billion-in-2020-21 39. who issues its first emergency use validation for a covid-19 vaccine and emphasizes need for equitable global access. world health organization. published december 31, 2020. accessed january 2, 2021. https://www.who.int/news/item/31-12-2020-who-issues-its-firstemergency-use-validation-for-a-covid-19-vaccine-and-emphasizesneed-for-equitable-global-access 40. r&d blueprint and covid-19. world health organization. published 2020. accessed december 13, 2020. https://www.who.int/teams/ blueprint/covid-19 41. a coordinated global research roadmap. world health organization. published march 12, 2020. accessed december 13, 2020. https://www. who.int/publications/m/item/a-coordinated-global-research-roadmap 42. coronavirus disease (covid-19) technical guidance: the unity studies: early investigation protocols. world health organization. published 2020. accessed december 13, 2020. https://www.who.int/ emergencies/diseases/novel-coronavirus-2019/technical-guidance/ early-investigations 43. fact sheet: explaining operation warp speed. us department of health and human services. published november 30, 2020. accessed december 6, 2020. https://health.mo.gov/living/healthcondiseases/ communicable/novel-coronavirus-lpha/pdf/fact-sheet-operationwarp-speed.pdf 44. nih to launch public-private partnership to speed covid-19 vaccine and treatment options. national institutes of health. published april 17, 2020. accessed december 6, 2020. https://www.nih.gov/news-events/ news-releases/nih-launch-public-private-partnership-speed-covid-19vaccine-treatment-options 45. nih launches clinical trials network to test covid-19 vaccines and other prevention tools. national institutes of health. published july 8, 2020. accessed december 6, 2020. https://www.nih.gov/news-events/ news-releases/nih-launches-clinical-trials-network-test-covid-19vaccines-other-prevention-tools 46. coronavirus treatment acceleration program (ctap). us food and drug administration. published november 17, 2020. accessed december 6, 2020. https://www.fda.gov/drugs/coronavirus-covid-19drugs/coronavirus-treatment-acceleration-program-ctap 47. coronavirus disease 2019 (covid-19). us food and drug administration. published december 11, 2020. accessed december 13, 2020. https://www.fda.gov/emergency-preparedness-and-response/ counterterrorism-and-emerging-threats/coronavirus-disease-2019covid-19 48. manufacturing, supply chain, and drug and biological product inspections during covid-19 public health emergency questions and answers: guidance for industry. us food and drug administration. published august 2020. accessed december 13, 2020. https://www.fda. gov/media/141312/download 49. coronavirus (covid-19) update: fda authorizes first diagnostic test for screening of people without known or suspected covid-19 infection. us food and drug administration. published july 24, 2020. accessed december 13, 2020. https://www.fda.gov/news-events/pressannouncements/coronavirus-covid-19-update-fda-authorizes-firstdiagnostic-test-screening-people-without-known-or get fit with amwa f ast i nteractive t raining amwa’s fit series helps medical communicators stay healthy. in only 15 minutes—jog your memory, tone your writing muscles, build your core skills, and stretch your knowledge. www.amwa.org/fit only $15 each / approved for .5 ce topics in the series include: } misplaced modifiers } mean, median, and mode } dangling participles } measures of variability https://stacks.cdc.gov/view/cdc/99303 https://www.who.int/news/item/03-12-2020-global-access-to-covid-19-vaccines-estimated-to-generate-economic-benefits-of-at-least-153-billion-in-2020-21 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https://www.who.int/news/item/31-12-2020-who-issues-its-first-emergency-use-validation-for-a-covid-19-vaccine-and-emphasizes-need-for-equitable-global-access https://www.who.int/teams/blueprint/covid-19 https://www.who.int/publications/m/item/a-coordinated-global-research-roadmap https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/early-investigations https://health.mo.gov/living/healthcondiseases/communicable/novel-coronavirus-lpha/pdf/fact-sheet-operation-warp-speed.pdf https://www.nih.gov/news-events/news-releases/nih-launch-public-private-partnership-speed-covid-19-vaccine-treatment-options https://www.nih.gov/news-events/news-releases/nih-launches-clinical-trials-network-test-covid-19-vaccines-other-prevention-tools https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap 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https://www.ismpp.org/annual-meeting https://www.aiip.org/conference https://www.asindexing.org/conferences/future-annual-conferences/ https://www.asindexing.org/conferences/future-annual-conferences/ https://healthjournalism.org/calendar-details.php?id=2423 https://www.councilscienceeditors.org/events/annual-meeting/cse-2022-annual-meeting/ https://www.councilscienceeditors.org/events/annual-meeting/cse-2022-annual-meeting/ https://www.emwa.org/conferences/future-conferences https://summit.stc.org https://customer.sspnet.org/ssp/events/2022-annual-meeting/ssp/am22/home.aspx https://customer.sspnet.org/ssp/events/2022-annual-meeting/ssp/am22/home.aspx https://www.societyforhealthcommunication.org/national-summit https://www.societyforhealthcommunication.org/national-summit https://www.diaglobal.org/flagship/dia-2022 a m w a news gail v. flores, phd / 2020–2021 amwa president 2021 president’s award recipient: dikran toroser, phd, cmpp the president's award is given by the amwa president to a member of amwa who has made distinctive contributions to the association at the chapter or national level. the nominee must have been an amwa member for 10 years and cannot have served on the executive committee. it is my great privilege to present this year’s president’s award to dikran toroser, phd, cmpp. dikran will receive the award in october in conjunction with the 2021 medical writing & communication conference. dikran is currently a director and publication planning group lead at takeda in cambridge, massachusetts. he has been an amwa member since 2008 and has been a diligent, hard-working volunteer ever since. i was lucky to get to know him when we volunteered together for the former pacific southwest chapter. dikran wrote a regular column in the chapter newsletter and spoke at chapter events. at the national level, he served on the committee to recruit volunteers and support members to form the new pacific southwest chapter and served for 2 terms on the nominating committee to create the slate of national amwa officers. he has also presented posters and led roundtables at annual amwa medical writing & communication conferences. most recently, we served together on the writing committee for the amwa-emwa-ismpp joint position statement on medical publications, preprints, and peer review as representatives of amwa, and he has presented on the statement to our various sister organizations. throughout his years as an amwa volunteer, dikran has been analytical, thoughtful, and fair, not to mention overwhelmingly kind and gracious. dikran has also served as an adjunct faculty member and consulting director for the university of california san diego extension medical writing programs for 6 years and is an active member of the international society for medical publication professionals (ismpp). please join me in congratulating dikran on this welldeserved honor! the golden apple award is presented to a member of amwa to honor consistent, outstanding workshop leadership. this year’s golden apple recipient is aaron bernstein, phd. the member awards committee was impressed with aaron’s long-term commitment to leading workshops for amwa and ability to keep his workshops engaging and his material timely and relevant. aaron has taught 31 workshops since 1998. he has been the sole leader of 2 regulatory-focused workshops, “regulatory aspects of the drug development process” and “current trends in drug regulations,” and leads workshops at annual conferences and conducts onsite training. aaron is a founding member and past president of the european medical writers association. he is a primary contributor to the development of the core reference tool and website, a detailed companion to the international council for harmonisation of technical requirements for pharmaceuticals for human use e3 guideline on clinical study reports. he is a co-author of peer-reviewed publications on the topic of clinical trial transparency and the production of clinical study reports. please join amwa in congratulating aaron. he will be acknowledged at the 2021 medical writing & communication conference, to be held virtually october 27-29. the member awards committee members were elizabeth brown, elise eller (chair), andrea gwosdow, karen klein, mary knatterud, susan krug (ex officio), marianne mallia, and kristina wassonblader. diane noland from amwa headquarters provided excellent support. the golden apple award: aaron bernstein, phd elise eller, phd / 2020-2021 director-at-large and chair and board liaison, member awards committee 128 amwa journal / v36 n3 / 2021 / amwa.org amwa journal / v36 n1 / 2021 / amwa.org 47 members of a lay audience may not understand that an evolutionary strategy is not something that the organisms are planning to do. so, depending on your intended audience, you may have to avoid using a shorthand or at least explain what the shorthand means. metonyms can also be used in medical writing, albeit cautiously. for example, the word practice is often used as a metonym to refer to a type of business in which a medical practitioner or group of practitioners provide care to patients. so, you might use the term “the practice” when you want to refer to such a business as a business or when you don’t want to specify a particular part of the business. for example, you could encourage patients to “contact the practice” without specifying which person or even which office to contact. your goal should be clarity. if the patients can contact any member of the staff, you can urge them to contact the practice. in general, you may wish to avoid unnecessary use of figurative language in a technical report, such as a clinical study protocol—especially if it is going to be translated. however, there is considerably more room for literary inventiveness in an opinion piece. in such pieces, authors may wish to express their own emotions and to evoke emotions in the audience, especially to underscore the importance and urgency of their message. in that situation, the writer may use figurative language for rhetorical effect. learn more metaphors, similes, and metonyms are not the only forms of figurative language. the silva rhetoricae web site (http://rhetoric.byu.edu/), maintained by dr gideon burton of brigham young university, provides an extensive list of figures of speech, all of which are named, defined, and categorized. many of these rhetorical figures have greek or latin names because they have been recognized since classical times to be valuable in persuasion. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: www.nottrivialbook.com; lthomas521@verizon.net international society for medical publication professionals april 12-14, 2021 virtual https://www.ismpp.org/annual-meeting association of independent information professionals april 14-16, 2021 virtual https://virtual21.aiip.org/ american copy editors society april 22-23, 2021 virtual https://aceseditors.org/conference american society for indexing april 30 to may 1, 2021 virtual https://www.asindexing.org/conference/2021-presentationproposals/ council of science editors may 3-5, 2021 virtual https://www.councilscienceeditors.org/events/upcomingevents/2021-cse-annual-meeting/ european medical writers association may 4-8, 2021 virtual https://www.emwa.org/conferences/future-conferences society for scholarly publishing may 24-27, 2021 virtual https://customer.sspnet.org/ssp/am21/home society for technical communication june 5-9, 2021 virtual https://summit.stc.org association of health care journalists june 24-27, 2021 austin, tx https://healthjournalism.org/calendar-details.php?id=2245 dia june 27 to july 1, 2021 virtual https://www.diaglobal.org/flagship/dia-2021 calendar of meetings please confirm with individual meeting hosts 2021 amwa medical writing & communication conference october 27-30, 2021 trends and opportunities for medical communicators www.amwa.org/conference http://www.amwa.org/conference http://rhetoric.byu.edu/ http://www.nottrivialbook.com mailto:lthomas521@verizon.net https://www.ismpp.org/annual-meeting https://virtual21.aiip.org/ https://aceseditors.org/conference https://www.asindexing.org/conference/2021-presentation-proposals/council https://www.asindexing.org/conference/2021-presentation-proposals/ https://www.asindexing.org/conference/2021-presentation-proposals/council https://www.councilscienceeditors.org/events/upcoming-events/2021-cse-annual-meeting/ https://www.councilscienceeditors.org/events/upcoming-events/2021-cse-annual-meeting/ https://www.councilscienceeditors.org/events/upcoming-events/2021-cse-annual-meeting/ https://www.emwa.org/conferences/future-conferences https://customer.sspnet.org/ssp/am21/home https://summit.stc.org https://healthjournalism.org/calendar-details.php?id=2245 https://www.diaglobal.org/flagship/dia-2021 amwa journal / v36 n1 / 2021 / amwa.org 43 joanna pendergrass, dvm / freelance medical writer, sandy springs, ga being a veterinarian and medical writer is a unique, if somewhat unexpected, combination of professional skills. i say unexpected because many people view veterinarians as being only in private practice, treating everything from dogs to pot-bellied pigs. the overwhelming majority of veterinarians are in private practice,1 so it’s not surprising that “veterinarian” and “writer” uncommonly appear in the same sentence. when i was veterinary school, nontraditional career paths for veterinarians beyond academia or the public sector were not widely discussed. i didn’t learn about medical writing until several months after i earned my veterinary degree. fast forward to today, with 8 years of medical writing and 4 years of freelance medical writing under my belt. although my path to and within medical writing has been circuitous, i am fortunate that i have been able to combine my veterinary training and love of writing into a rewarding career. what i’ve learned about myself and the medical writing profession can help other veterinarians who are contemplating making the professional leap into medical writing. my lessons learned 1. think outside of the clinical box my year of clinical rotations made it clear that the private practice world wasn’t for me. i knew that i did not want to deal with the daily grind of constant client-facing and other rigors of clinical veterinary medicine. if you know that private practice isn’t for you, don’t force it. doing so could leave you feeling like a frustrated square peg in a round hole, increasing your risk of career resentment. remember that your veterinary degree opens many more doors beyond those of private practice. if you enjoy practicing but don’t want to do it full-time, consider medical writing as a part-time pursuit. as veterinarians, we know that pet owners are hungry for credible and accurate pet care information. medical writing offers an excellent opportunity to translate our veterinary training into practical and beneficial information for pet owners. 2. be ready for misunderstandings when i explain to people what i do, i occasionally receive a response along the lines of, “so, why aren’t you a real vet?” that question used to sting a little bit. why did people equate my realness as a veterinarian with whether i worked in private practice? eventually, i learned that i didn’t need to defend my veterinary degree or my decision to use it to pursue an alternative career path. as you transition into medical writing, don’t be surprised if you get questioned in the same way. use the opportunity to educate people on the versatility of a veterinary degree beyond private practice. 3. assess your transferrable skills at first glance, it might not seem like your years of veterinary training would prepare you for a medical writing career. take a closer look. many skills can transfer from veterinary medicine to medical writing, including attention to detail, critical thinking, scientific and medical expertise, and strong written communication skills. with some more introspection, you can probably come up with more skills. write them down, and you’ll realize that you’re more prepared than you thought you were to become a medical writer. 4. do your research on medical writing during my clinical rotations, i enjoyed writing the patient discharge summaries and medical notes on patient cases. more than once, a clinician would compliment my writing. around the career block journey from veterinary medicine to medical writing 44 amwa journal / v36 n1 / 2021 / amwa.org after attending a career symposium that featured emma hitt nichols, phd, els, as a panelist, i decided that medical writing was the way to go for me. i joined amwa and browsed through old editions of the amwa journal to learn more about the profession. i also attended local amwa chapter meetings and conducted informational interviews with medical writers. if you decide that you want to become a medical writer, research the profession and determine which area of medical writing appeals most to you. the more research that you do, the more comfortable you’ll feel about making the transition into medical writing. 5. consider human or veterinary medical writing my first medical writing positions were at medical communication agencies that focused on human oncology and hematology. although i understood the science and medical terminology, writing for human academic and pharmaceutical audiences did not suit me well. when i began freelancing, i realized that veterinary writing was the better fit. over time, my freelance medical writing niche became clear: pet owner education. although i do some human health journalism writing, my passion lies in educating pet owners. as veterinarians, we recognize the many overlaps between human and veterinary medicine and can switch between the two with relative ease. thus, human or veterinary medical writing are equally reasonable career options. if you choose human medical writing, be prepared to explain why, as a veterinarian, you’re qualified to write on human medical topics. a potential client or employer might need a little extra convincing that you can translate your veterinary knowledge to human health. 6. talk to other veterinarians who are medical writers being the only veterinarian at medical communication agencies was a “fish out of water” experience for me. once i started connecting with other veterinary medical writers on linkedin and through amwa, i realized that i wasn’t the only veterinarian in the medical writing world. veterinary medical writers understand your professional background and can help you navigate your transition into medical writing. 7. get involved in amwa amwa is the best organization for medical communicators at all experience levels. being active in the organization pays dividends when it comes to learning about employment and freelancing opportunities and moving forward in the profession. get involved in your local chapter by serving on the chapter board or assisting with other volunteer activities. once you’ve found your footing at the local level, consider being active on the national level as well. in addition to being active, search the amwa directory for members who are veterinarians and send an introductory email. we’re more than happy to connect with you and help you along your medical writing journey. 8. recognize the uniqueness that you bring to medical writing veterinarians bring a unique perspective to medical writing. not only do we understand the interconnectedness of human and veterinary medicine, but we also recognize the need for collaboration between human and veterinary medical experts to address public health challenges and combat infectious disease. this perspective adds a richness to medical writing by expanding the breadth and scope of medical communication. veterinary medical writers are aptly positioned to apply their veterinary training and knowledge to their writing, whether it is in human or veterinary health. final thoughts the journey from veterinary medicine to medical writing may not be straightforward, but it can certainly be rewarding. the medical writing profession offers an opportunity for veterinarians to use their veterinary expertise to benefit both human and veterinary medical communication. your veterinary degree opens up many professional possibilities outside of private practice. if medical writing interests you, explore and pursue the medical writing niche that suits you best and continue finding ways to hone your craft and grow as a writer. connect with other veterinary medical writers and recognize the value and uniqueness that you bring to the medical writing table. even if you traded your stethoscope for a pen, you are still a real veterinarian. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: joanna@jpencmc.com reference 1. 2018 avma report on the market for veterinary services. american veterinary medical association website. published 2018. accessed august 24, 2020. https://www.avma.org/sites/default/files/ resources/2018-econ-rpt3-veterinary-services.pdf around the career block mailto:joanna@jpencmc.com https://www.avma.org/sites/default/files/resources/2018-econ-rpt3-veterinary-services.pdf v37 n2 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 47 the john p. mcgovern award is named in honor of john p. mcgovern and is presented to a member or nonmember of amwa to recognize a preeminent contribution to any of the various modes of medical communication. the mcgovern award is presented during amwa's medical writing & communication conference. the american medical writers association (amwa) is pleased to recognize preeminent contributions to the various modes of medical communication through the john p. mcgovern award. the amwa president presents the mcgovern award, named in honor of renowned allergist and philanthropist john p. mcgovern, md, during its annual medical writing & communication conference. it is an honor to name peter j. hotez, md, phd, an internationally recognized physician–scientist, global health advocate, accomplished author, and 2022 nobel peace prize nominee, as this year’s john p. mcgovern award recipient. considered a pioneer in his field, dr hotez is an expert in neglected tropical diseases, global health, and vaccinology. based in houston, texas, he is the founding dean of the national school of tropical medicine and is a professor of pediatrics and molecular virology and microbiology at baylor college of medicine. in addition, he is a university professor at baylor university and is the co-director of texas children's hospital’s center for vaccine development. dr hotez has a passion for developing new interventions for global diseases of poverty, developing vaccine diplomacy–communicating science, and combatting rising antiscience sentiment, and his passion is reflected by many prestigious awards, roles, and honors. he holds the endowed chair in tropical pediatrics at texas children’s hospital, for example, and served as a us science envoy during president barack obama’s administration. he is an elected member of the national academy of medicine and american academy of arts and sciences. i first met dr hotez in 2017 when i served as president of amwa’s southwest chapter. i had the honor of presenting dr hotez with the chapter’s john p. mcgovern award in recognition of his research and vaccine development. since then, his advocacy for health equity among underserved populations, continued work on vaccines and covid-19, and passion for communicating science have continued to resonate with medical communicators. dr hotez’s scientific publications and advocacy have addressed treatment needs for millions of underserved populations afflicted with neglected tropical diseases around the world. he has co-led efforts to develop new “antipoverty” vaccines for neglected tropical diseases, including a new recombinant protein covid-19 vaccine for global health. his contributions to the field of medical communication include more than 650 peer-reviewed journal articles and 5 single-author books, such as his most recent and timely preventing the next pandemic: vaccine diplomacy in a time of anti-science. his other books include blue marble health: an innovative plan to fight diseases of the poor amid wealth and vaccines did not cause rachel’s autism (johns hopkins university press); the latter publication is dr hotez’s personal reflection on his journey as a pediatrician, vaccine scientist, and father of an autistic child. during the covid-19 pandemic, dr hotez has regularly appeared on national platforms to educate the world on vaccines and to address the spread of misinformation. his research on coronaviruses began a decade prior to the pandemic. through this knowledge and diplomacy, he has become a regular contributor and trusted source to media outlets such as cnn, nbc news, cbs news, abc news, npr, and the washington post. i will be honored once again to present a much-deserved award to this leader in medical communication on behalf of the entire amwa membership as we gather on november 2-5 in denver, colorado, for this year’s conference. together, we will extend our sincere congratulations and gratitude as dr hotez joins an esteemed group of mcgovern award recipients at the national level as amwa’s 2022 john p. mcgovern award recipient. katrina r. burton, bs / 2021-2022 amwa president 2022 john p. mcgovern award recipient: peter j. hotez, md, phd amwa news http://www.amwajournal.org 48 amwa journal / v36 n1 / 2021 / amwa.org the year 2020 was one that we will not soon forget. a global pandemic brought the world to its knees, social unrest reached a boiling point, and divisive politics made us weary. and yet, there were countless bright spots amid the chaos. one of those bright spots occurred right here within amwa, with katrina burton, bs, elected to serve as amwa’s next president-elect. she is the first black person to hold this position in the organization. the announcement of her election filled me with excitement. being asked to interview burton for the journal was like icing on the cake. as a black woman, i felt honored to be tasked with interviewing burton to learn more about her life, medical writing career, and goals for amwa. i sat down with burton—via zoom, of course—prepared for an interview that ended up feeling more like a conversation between friends. growing up in texas burton was born in houston, texas, and grew up on the city’s north side. like many of us, her original career aspirations didn’t include medical writing. “i always had an interest in the medical field, especially the skin,” she said. her older sister battled a severe case of eczema, inspiring burton to want to become a dermatologist. without google as an aid, she spent time at the school library and took advantage of her family’s home encyclopedia collection to learn about dermatology. even with dreams of becoming a medical doctor, burton loved writing. she enjoyed reading and writing fiction and family stories. “i was always told that i had a vivid imagination and that i should become a writer,” she said. after graduating from booker t. washington high school, a historically black high school in houston, burton attended texas a&m university in college station, texas. initially entering college as a pre-med major, she switched to journalism, earning a bachelor of science in journalism and a minor in marketing. while at texas a&m, she served as a backup writer for the battalion, the college newspaper. career beginnings “my journey is a very interesting story,” burton explained as she described her first few jobs after college. burton decided to stay in the houston area after graduation. although she loved writing, she discovered that writing for the local newsletter wasn’t exactly lucrative. she took a job opportunity in retail instead while she pondered her next steps. at a local retail clothing store, she began as an assistant manager and was promoted to manager. burton weaved her love of writing in with her managerial responsibilities by creating a store newsletter. this newsletter caught the attention of the retail company’s national office, and burton was asked to expand the newsletter to the store’s local region. knowing that writing was her true passion and retail would not be part of her long-term career plans, she started looking for opportunities that combined both her management and writing skills. in addition to working in retail, burton also explored her interest in graphic design and layout, still managing to weave writing into her work, landing several positions with wellknown companies over the years. becoming a medical writer edging ever closer to medical writing, burton worked as the marketing manager at gulf coast regional blood center for 4 years. in her position, she worked with her team to recruit talent to appear in television commercials and marketing joanna pendergrass, dvm / freelance medical writer, sandy springs, ga members matters c re d it : t h e u n iv er si ty o f t ex as m d a n d er so n c an ce r c en te r making history: an interview with katrina burton, amwa’s new president-elect amwa journal / v36 n1 / 2021 / amwa.org 49 materials in support of various projects, such as incentive programs and marketing initiatives. “this is where i honed my skills with project development,” she said. she spoke with pride about leading the launch of the center’s african american commits for life program (now the diversity program), aiming to increase the number of black blood donors. within the first 6 months of the program, blood donations from black blood donors increased by 25%. as a part of her position, burton wrote extensively for the blood bank and worked with philanthropic organizations on strategic initiatives. working at the center brought her back into the medical field, creating the beginnings of her medical writing career. burton then began working at the university of texas md anderson cancer center in houston, where she has been for 13 years. personal experiences spurred her decision to work at md anderson. her father passed away from prostate cancer, and other family members have had a range of cancers and health issues. at md anderson, she first served as an external communications specialist, then senior communications specialist. for 7 years, she covered cancer prevention, worked with local and national reporters, and wrote about groundbreaking cancer research and clinical trials. currently, she serves as a program manager in the public relations office, managing the communications and media relations for md anderson’s children’s cancer hospital. in this role, she continues to write and work with media to share pediatric patients' experiences, essential research, and important patient programs. burton’s work varies from day to day, and she loves it. “i don’t just write stories and work with media: i also build relationships with researchers, clinicians, and other colleagues,” she said. “i truly enjoy getting to know patients and their families, and i am honored when they share a glimpse of their cancer journey with me. seeing the patients do well and achieve success in life gives me so much joy.” she has continued to pursue her passion for learning about the health care industry and sharing that information with others. “when you’re in a place where you can do good and share important stories, your job doesn’t feel like a job. rather, it feels like a calling,” burton remarked. getting involved in amwa in 2010, early in her medical writing career, burton’s director advised her to seek out science writing organizations to join. a google search listed amwa as the first search result. she joined amwa shortly before the annual conference that year. the conference, in her words, was “love at first sight.” it was an exhausting yet exhilarating experience for burton, connecting her with others who were passionate about medical writing. since then, she has attended every amwa medical writing & communication conference, participating as a roundtable facilitator (2012, 2013) and open session speaker (2013, 2017, 2019). burton’s involvement in amwa could fill an entire page. as a bonafide lover of volunteering, she first held numerous roles in the southwest chapter. to name just a few, she served as the chapter’s publicity coordinator, president and immediate past president, chapter delegate to amwa’s board of directors, and the chapter advisory council (cac) representative. after being instrumental in the most recent restructuring of amwa’s national board, burton was invited to become active on the national level, serving as the first chair of the cac. when she was elected amwa national secretary, she was chair of the constitution and bylaws committee. now, as presidentelect, she is the chair of the nomination committee. in 2020, burton earned the distinction of being named a 2020 amwa fellow, a designation bestowed upon members who have achieved an exceptional level of service to the organization over time. to add to her extensive list of amwa activities, burton also actively volunteers in her local community, serving on several boards and councils. she works with local schools to inspire a love of communication in young children. “this work helps build a diverse group of future communicators and allows me to do my part to ensure that the field of communications continues to thrive with different voices,” she said. tackling misinformation burton believes that health and science misinformation is the biggest challenge in medical communication. this is not a new problem, of course, but medical communicators are uniquely positioned to take on this challenge. to do so, burton encourages all medical communicators to be proactive in writing accurate, fact-based information and when you’re in a place where you can do good and share important stories, your job doesn’t feel like a job. rather, it feels like a calling.   members matter 50 amwa journal / v36 n1 / 2021 / amwa.org being credible sources of medical information. amwa, she believes, can be the driving force in countering misinformation and teaching medical communicators how to be part of that driving force. serving as president-elect since joining amwa, burton has been continually inspired by the organization’s leaders with whom she has worked. she takes her commitment to amwa, and her new role as president-elect, seriously. “it is an honor and privilege to be elected as president-elect of an organization that is doing essential, critical, and amazing work to promote excellence in the medical communication field,” she said. as president-elect, burton aims to grow amwa’s membership, expand amwa online learning, and encourage membership among medical writers who specialize in public relations and marketing. she also aspires to increase the ethnic diversity of amwa’s membership. to burton, though, diversity in medical communication is about more than just ethnicity. it is also about a diversity of writing specialties, employment status, and medical topics (cancer, dental care, etc.). “an organization is strenghened by its diversity,” she said. “diversity allows the opportunity to be educated on different perspectives, ideas, and values that can be crucial to organizational growth.” becoming the first black female president-elect burton considers being amwa’s first black female presidentelect an accomplishment for her personally and for amwa. at first, though, she did not even realize that she was the first. nevertheless, she recognizes the significance of this moment in amwa’s history. she plans to use her platform to encourage more minority medical writers to join amwa, get involved, and pursue leadership positions within the organization. closing thoughts as we closed out our interview, i asked burton to provide some words of wisdom for medical communicators who are starting their careers. “take advantage of amwa’s educational resources and tools, attend the amwa medical writing & communication conferences, volunteer in your local amwa chapter, and be intentional about building your expertise to align with your career trajectory.” she also recommended taking advantage of amwa’s many networking opportunities that can promote collaborations and long-lasting friendships. i am thrilled to see burton serve as amwa’s president-elect. while holding amwa close to her heart, there is no doubt that she will continue to serve the organization well and push the medical communication field forward. author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. author contact: joanna@jpencmc.com members matters learn online macroediting microediting save over 15% when purchasing as a package! mailto:joanna@jpencmc.com http://amwa.mycrowdwisdom.com/diweb/catalog/item/id/1628930/q/f2=1&q=macro&c=185 v37 n2 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 49 asian council of science editors 8th annual meeting of the acse august 21, 2022 virtual https://theacse.com/2022/ international conference on communication in healthcare september 5-9, 2022 glasgow, scotland https://each.international/eachevents/conferences/icch-2022/ regulatory affairs professionals society september 11-13, 2022 phoenix, arizona https://www.raps.org/regulatory-convergence international society of managing and technical editors november 1-3, 2022 virtual https://www.ismte.org/events/eventdetails.aspx?id=1630533&group= amwa medical writing & communication conference november 2-5, 2022 denver, colorado https://www.amwa.org/conference american public health association november 6-9, 2022 boston, massachusetts https://www.apha.org/events-and-meetings/annual calendar of meetings http://www.amwajournal.org https://theacse.com/2022/ https://each.international/eachevents/conferences/icch-2022/ https://www.raps.org/regulatory-convergence https://www.ismte.org/events/eventdetails.aspx?id=1630533&group= https://www.amwa.org/general/custom.asp?page=conference https://www.apha.org/events-and-meetings/annual amwa journal / v36 n3 / 2021 / amwa.org 101 f e a t u r e abstract the ability to use information easily and effectively is essential to medical communication. yet who uses medical information, when they use it, and how they use it has changed with the rise of personal medical technologies and increased reliance on telehealth practices. as a result, a range of nonmedical professionals now regularly engage in different health care activities. this situation represents a challenge medical writers must address to ensure the health and wellness of individuals who use their content. meeting usability expectations involves understanding both the cognitive models writers use to create content and those that readers rely on when using content to achieve a health care objective. such mental models, however, vary from audience to audience on the basis of experiences. as a result, medical writers need to understand what mental models entail in order to create materials that meet an audience’s usability expectations. this article provides medical writers with an overview of what these mental models encompass and how they affect an audience’s usability expectations. the article also presents a 5-step process medical writers can employ to identify and address such usability expectations when creating content for different groups. the related approach begins with researching and identifying the mental models upon which audiences base their usability expectations. the approach then focuses on applying the resulting findings to create draft content for the related audience. the approach then concludes with a process for testing (and revising, if needed) initial content via input from members of the related audience. through this process, medical writers can more effectively identify and meet an audience’s usability expectations when creating medical content. usability—the ability to use items easily and effectively— has long been important to medical communication.1-6 the role of usability in health and medicine, however, has become more acutely important as the rise of wearable devices7-8 and the spread of telehealth practices9,10 increasingly place different health care activities in the hands of patients. in these situations, failure to use content effectively can have adverse effects, including medical complications, injury, and even death.11 addressing these situations involves understanding the mental models guiding how audiences use health care content.12 this article examines what these mental models entail and how they affect an audience’s usability expectations for health care. the article also presents an approach for researching such expectations and applying related findings to develop usable health care content for different groups. the article’s objective is to provide medical writers with an approach for creating usable health care materials for different audiences. mental models and content considerations when we write, we use a cognitive model—a mental picture or representation—to guide the process.13,14 if we wish to explain how to use a blood pressure cuff, for example, we access the mental model we have for that process (eg, what it “looks like”) and produce content/text that describes the activities depicted in this representation.14,15 our goal is to provide individuals with information they can use to mentally re-create the same depiction in order to perform that process. an audience’s ability to perform the related activity thus becomes a matter of how effectively individuals can re-create and follow a mental model as described in the content we provide. this ability to re-create mental representations guides how effectively audiences can use content to perform tasks. these mental models are not innate; we learn them through our experiences over time.15-17 the more we notice an activity occurring a certain way in a particular location, the more we perceive these situations as “standard” representations that become our mental models for activities.17,18 we kirk st.amant / louisiana tech university, ruston, la; university of limerick, limerick, ireland a cognitive model approach to creating usable health care content 102 amwa journal / v36 n3 / 2021 / amwa.org then use these models to conceptualize processes when creating related content. additionally, the more often we encounter a process occurring in a specific setting, the more that location—and everything and everyone in it—becomes central to the metal model we use to conceptualize the activity.19-21 so, the more we observe individuals checking their blood pressure a certain way in their kitchen, the more we associate “dynamics of kitchen setting” with where, when, and how to perform that process. as a result, mental models contain more than depictions of how to perform activities. they also include expectations regarding the individuals involved, the objects used, and the processes for using them in a particular setting.19-21 because experiences can vary, audiences and authors could use different mental models to conceptualize a situation. such variations can have implications for how individuals create or use content.15-17,21 in medical communication, such differences often involve aspects associated with performing health care activities (e.g., using a device to check one’s blood pressure).1,2,12 these differences generally reflect expectations associated with a context of care—or the location where individuals expect to perform a health care process and what that processes entails in that setting.1,12 these variations can affect how audiences perceive and understand content describing health care activities,15-18 and such factors can affect the usability of health care content.1,2,15-18 context and conceptualization in terms of usability in health care contexts, 2 major problems can arise when the mental model of authors/content creators and the readers/content users diverge. misalignment misalignment occurs when author and audience have different mental models for the same situation.12,21 in these cases, the audience might perceive an author’s content as • explaining an experience or process in a way that differs from what audience members expect, • describing a process that conflicts with an audience’s expectations and is therefore considered incorrect, and • missing essential elements as per the audience’s mental model. these factors could lead audiences to doubt the credibility of content or try to supplement seemingly incomplete content with information based on the audience’s own experiences. such situations can affect if and how audiences use health care materials. comprehension occasionally, an audience might have no prior mental model to guide expectations.16-18 in these cases, content based on the author’s mental model might not provide audience members with the information needed to effectively re-create a mental representation for a process. this situation could leave individuals wondering what to do or leave them unable to comprehend and use content. as a result, audiences might • avoid using content they cannot understand, • guess what a writer means to convey, but use inaccurate assumptions to guide actions, and/or • misconceptualize information and perform an activity incorrectly. such situations could prompt audiences to perform a process in a way that results in adverse consequences, ranging from making a condition worse to causing permanent injury. such situations reveal how successful medical communication requires an understanding of the mental models audiences use to conceptualize health care information.15,16 medical writers can benefit from strategies that help identify such models (or the lack thereof) and the associated dynamics of where a process occurs, what it entails, and who it involves.12,21 such approaches should focus on collecting the model-specific information an audience relies on to guide the use of content. mapping mental models understanding an audience’s mental models involves identifying the dynamics associated with a context of care—the location audiences associate with a health care activity.1,2,12,21 these dynamics include determining who the members of an audience are, how their experiences have shaped their health care expectations, and what aspects they associate with health care processes. to better understand such factors, researchers with louisiana tech university’s center for health and medical communication reviewed the literature on cognition, usability, and design in health care contexts. this review led to the development of an approach for researching an audience’s contextof-care expectations. the researchers then conducted pilot studies to assess this approach and used the resulting feedback to revise the process. these activities resulted in a 5-step method for researching, designing, and testing communication materials for different audiences. called “mapping contexts of care,” the objective of this approach is to help medical writers identify and address the mental models that shape audience expectations of health care activities. this mapping approach works as follows. step 1: identify the audience for health care content medical writers must first identify the audience for which they will create content. this process entails gathering information amwa journal / v36 n3 / 2021 / amwa.org 103 on a group’s background (i.e., who individuals are and what they know about a topic) as well as on • geographic information on the health care options (eg, clinics, hospitals, pharmacies, etc.) that are available based on where individuals live and what transportation options they can use and • insurance information affecting the health care options available to patients (ie, treatment patients can afford) and where individuals can access care (eg, a local physician’s office vs a free clinic). such factors are essential to understanding location-based experiences that shape an audience’s mental models for health care activities. step 2: select a method for collecting data after identifying an audience, medical writers need to collect data on the mental models that shape expectations of health care activities. to do so, medical writers can use the following tools: • individual interviews asking individual members of an audience questions about their expectations, assumptions, and associations for where and how certain care is provided; • focus groups assembling 5-10 members of an audience and asking them to answer questions as a group, as such situations might help individuals remember details or provide clarification; and/or • mixed methods that use both interviews and focus groups to collect data and compare individual and group responses to better understand audience expectations for a context of care. these approaches would all use the same questions, and the number of interviews and focus groups conducted would depend on the time and funds allocated for a project. in each case, the resulting information can provide insights on an audience’s mental models for health care. medical writers can use such information to develop content according to an audience’s context-of-care expectations. step 3: craft questions for collecting information audiences could use different mental models for a context depending on when they perform an activity. such timing dynamics, however, can be significant, for who is in a location and what is in a location at a particular time can affect what audiences expect to do in a setting.22 for this reason, researching mental models requires audience members to identify both the location where they perform an activity and the time when they perform the activity in that context. to account for these factors, medical writers need to ask certain questions in a particular sequence. the objective is to prompt audience members to access the correct mental model for a health care activity in terms of time (when) and place (where). doing so involves asking the following questions in the following order. question 1: when do you do x (eg, check your blood pressure)? the dynamics of a location can change at different points in time, and individuals could have different expectations for a location based on when they use items in a setting.22 asking audience members “where” they perform a health care activity might, therefore, prompt individuals to access a mental model for a location at the wrong point in time (i.e., one other than when they engage in health care). as a result, audience members might describe a mental model that does not reflect the persons, items, situations, etc., in a location when they perform a health care activity. medical writers should therefor begin their questioning by asking audience members when they perform an activity to prompt individuals to access the correct mental model they associate with performing an activity in a location.23 question 2: where do you do x (eg, check your blood pressure)? can you describe that location? once time is established, the medical writer can ask audience members where they perform the related process. knowing the place, however, does not inherently clarify what an audience expects to encounter and use in that location. medical writers therefore need to ask individuals to also describe that setting in order to provide more complete information on model-related expectations. to this end, medical writers might ask individuals to sketch that space and identify/label items as they go. alternatively, medical writers could sketch the location as audience members describe it and ask for modifications, additions, etc., to such sketches during this process. question 3: who helps with doing x (eg, process of checking your blood pressure)? various individuals (eg, patients, patients’ family members, caregivers, etc.) could participate in different activities (eg, checking blood pressure) and use certain items (eg, a blood pressure cuff). medical writers need to identify such factors and craft content that addresses associated expectations. such content can better convey what audience members expect to do themselves compared with what audience members expect to rely on others to do for them in a context of care (eg, create instructions telling individuals how to let a caregiver use a sphygmomanometer to take their blood pressure). question 4: can you describe the process to me? who does what? mental models for health care generally encompass all activities occurring during a care-related process. by having 104 amwa journal / v36 n3 / 2021 / amwa.org audience members provide step-by-step descriptions of a process, medical writers can identify the activities audiences associate with a health care activity. these specifics include what tasks are involved, who performs them, and what is used (and by whom). question 5: what do you (or others) use to perform this process? can you describe that item? many health care activities involve different items used to perform certain tasks. what those items are—and what characteristics they must have for audiences to recognize and use them—can vary from audience to audience.24 medical writers need to identify such factors to create content that reflects expectations audiences use to identify the items and individuals associated with a health care process. step 4: apply information to create initial materials after completing all interviews and/or focus groups, medical writers would compare responses to identify common expectations audiences have for health care activities in a location. medical writers could use this information to create • a depiction (eg, an image) of the audience’s mental model for where a process occurs, what items individuals use, who uses them, and how; and/or • a checklist of location-related factors, individuals, items, and tasks to address when creating content for members of that audience. such items would constitute a draft representation of the mental models an audience uses to conceptualize a particular health care process in a context of care. medical writers could use such tools to guide content creation when developing health care materials for a particular audience. step 5: test, revise, and finalize materials the materials created through this process (i.e., depictions and/or checklists) are not final. rather, medical writers should use them to create draft content—text, visuals, online materials, etc.—to assess how effectively such items match an audience’s mental models. for this testing, medical writers would recruit new members of the intended audience (i.e., persons not involved in earlier interviews and focus groups) to avoid biased responses based on prior familiarity with the project.25 medical writers would then ask these individuals to use draft content to perform a health care process in the related context of care. for this testing, medical writers could use the following tools: • talk-aloud protocols: these are processes in which medical writers meet with members of the intended audience and observe these individuals as they use draft materials to perform a health care activity in the related context of care.26 individuals are asked to “talk aloud” during this process and note what they are doing, why, and their impressions as they perform the process. after individuals complete the task, medical writers could ask questions about what aspects of the draft content need revision (and how to revise materials) to enhance usability. medical writers could also ask if anything should be removed from or added to the draft content to make it more usable. and/or • focus groups and/or interviews: medical writers would first request that members of the intended audience use draft content to perform a health care activity in the associated context of care. medical writers would then conduct follow-up focus groups and/or interviews to ask individuals for suggestions on revisions needed to enhance the usability of that content.27 medical writers could also ask if anything should be removed or added to enhance the usability of that content. medical writers would use information resulting from this testing to revise both draft content and associated materials used to create it. they would then test this revised content with new members of the intended audience to determine if additional revisions are needed. this process of testing, collecting comments, revising, and testing revised materials would continue until a final version is confirmed or until time and funds for such activities run out. in either case, the objective is to create usable materials that best reflect the mental models an audience uses to engage in health care activities. challenges and considerations major challenges related to this approach include identifying and recruiting individuals for the data collection and the testing done to map mental models and create related materials. attracting enough members of an audience for the interviews, focus groups, and testing sessions involved can be difficult depending on the availability and willingness of individuals. similarly, effectively identifying and using channels for disseminating calls for participation can create challenges that affect the size and representativeness of groups participating in these activities. additionally, context-related dynamics often change over time. as a result, medical writers need to regularly test and re-assess materials used to guide content creation in order to determine if they still reflect the experiences and expectations amwa journal / v36 n3 / 2021 / amwa.org 105 of an audience. if not, then medical writers need to review and even redefine who the audience for content is. they then need to engage in new data collection, content creation, and testing to address expectations based on new or changed mental models for health care processes. finally, responses to questions 3-5 in the previous section could reveal the need to create content for a different audience—such as caregivers, friends, or family members—who perform essential activities during a health care process. such individuals become a new and necessary audience for health care content associated with a process. as these audiences use mental models to guide their activities, creating such content would mean identifying the mental models this audience has for a process. doing so would mean mapping such models via the same approach to research, drafting, testing, and revising content described previously. conclusion an understanding of mental models can help medical writers create content that meets an audience’s usability expectations. the result can be content audiences can easily and effectively use in the contexts where they engage in a health care activity. the approach described in this article can help medical writers identify the dynamics of such models and create content that meets audience expectations. through a combination of researching expectations and testing materials, medical writers can develop content audiences can use to effectively engage in health care. such approaches can be important to addressing new situations that might arise as societies emerge from covid-19 restrictions. they can also help medical writers respond effectively to different social changes, economic changes, and other changes that might affect health care practices and processes in the future. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: kirk.stamant@gmail.com references 1. melonçon lk. patient experience design: expanding usability methodologies for health care. commun design q rev. 2017;5(2):19-28. 2. melonçon lk. patient experience design: technical communication’s role in patient health information and education. intercom. 2016;63(1): 12-15. 3. johnson an. it’s time for medical writers to get big and dirty: writing opportunities in data, biometrics, and technology. amwa j. 2017;32(1): 23-24. 4. lang t. just who are we and what are we doing, anyway? needed research in medical writing. amwa j. 2009;24(3):106-112. 5. lang t. medical writing up close and professional: establishing our identity. amwa j. 2015;30(1):10-17. 6. jones bc. design for care: innovating health care experience. rosenfeld media; 2013. 7. wisdom g. patient experience design: a game changer for health care. medium website. published february 14, 2017. accessed march 7, 2021. https://medium.com/sutherland-labs/patient-experience-design-agame-changer-for-healthcare-31351623e010 8. st.amant k. user experience design for health care. tcworld. july 2020:18-21. 9. telehealth growth during covid-19. ahip website. published july 7, 2020. accessed march 7, 2021. https://www.ahip.org/telehealth-growthduring-covid-19/ 10. fernandez m. telehealth to experience massive growth with covid-19 pandemic, says frost & sullivan. frost & sullivan website. published may 13, 2020. accessed march 7, 2021. https://ww2.frost.com/news/ press-releases/telehealth-to-experience-massive-growth-withcovid-19-pandemic-says-frost-sullivan/ 11. clark e, israelski e. total recall: the consequences of ignoring medical device usability. user experience magazine website. published march 2012. accessed march 7, 2021. https://uxpamagazine.org/total-recall/ 12. st.amant k. cognition, care, and usability: applying cognitive concepts to user experience design in health and medical contexts. j tech writing commun. 2020;51(3):1-20. doi:10.1177/0047281620981567 13. lindstrom m. buyology: truth and lies about why we buy. broadway books; 2010. 14. st.amant k. of scripts and prototypes: a two-part approach to user experience design for international contexts. tech commun. 2017;64(2): 113-125. 15. eyal n. hooked: how to build habit-forming products . portfolio/ penguin books; 2014. 16. duhigg c. the power of habit: why we do what we do in life and business. random house; 2012. 17. aitchison j. (1994). bad birds and better birds: prototype theory. in: clark vp, eschholz pa, rosa af, eds. language: introductory readings. 4th ed. st. martin’s press; 1994:445-459. 18. ratey jj. a user’s guide to the brain: perception, attention, and the four theaters of the brain. vintage; 2002. 19. tomkins ss. script theory. in: arnoff j, rabin ai, zucker ra, eds. the emergence of personality. springer; 1987:147-216. 20. tomkins ss. script theory: differential magnification of affects. nebr symp motiv. 1978;26:201-236. 21. st.amant k. reflexes, reactions, and usability: examining how prototypes of place can enhance uxd practices. commun design q. 2018;6(1):45-53. doi:10.1145/3230970.3230976 22. kobbe l, weinberger a, dillenbourg p, et al. specifying computersupported collaboration scripts. intl j comput support collab learn. 2007;2(2-3):211-224. doi:10.1007/s11412-007-9014-4 23. anderson j. what is priming psychology and what is it used for? better help website. published december 17, 2020. accessed june 5, 2021. https://www.betterhelp.com/advice/psychologists/what-is-primingpsychology-and-what-is-it-used-for/ 24. st.amant k. culture and the contextualization of care: a prototypebased approach to developing health and medical visuals for international audiences. commun design q. 2015;3(2):38-47. doi:10.1145/2752853.2752858 25. apsee. user research bias: how it hurts your app and what you can do about it. ux planet website. published august 3, 2018. accessed june 10, 2021. https://uxplanet.org/user-research-bias-how-it-hurts-your-appand-what-you-can-do-about-it-4433d295229c 26. frishberg l, lambdin c. presumptive design: design provocations for innovation. morgan kaufmann; 2015. 27. focus groups. usability.gov website. published september 30, 2020. accessed june 10, 2021. https://www.usability.gov/how-to-and-tools/ methods/focus-groups.html mailto:kirk.stamant@gmail.com https://medium.com/sutherland-labs/patient-experience-design-a-game-changer-for-health https://medium.com/sutherland-labs/patient-experience-design-a-game-changer-for-healthcare-31351623e010 https://www.ahip.org/telehealth-growth-during-covid-19/ https://www.ahip.org/telehealth-growth-during-covid-19/ https://www.ahip.org/telehealth-growth-during-covid-19/ https://ww2.frost.com/news/press-releases/telehealth-to-experience-massive-growth-with-covid-19-pandemic-says-frost-sullivan/ https://uxpamagazine.org/total-recall/ https://www.betterhelp.com/advice/psychologists/what-is-priming-psychology-and-what-is-it-used-for/ https://www.betterhelp.com/advice/psychologists/what-is-priming-psychology-and-what-is-it-used-for/ https://www.betterhelp.com/advice/psychologists/what-is-priming-psychology-and-what-is-it-used-for/ https://uxplanet.org/user-research-bias-how-it-hurts-your-app-and-what-you-can-do-about-it-4433d295229c https://uxplanet.org/user-research-bias-how-it-hurts-your-app-and-what-you-can-do-about-it-4433d295229c https://uxplanet.org/user-research-bias-how-it-hurts-your-app-and-what-you-can-do-about-it-4433d295229c https://www.usability.gov/how-to-and-tools/methods/focus-groups.html amwajournal.org 27session reports • second (or even third) computer monitor • printouts of grant request for proposals and request for applications • templates for writers • glossaries from cancer centers or other stakeholders • digitally curating information • time tracking/management tools • optimizing software already in use • checklists and detailed project notetaking a medical writer’s ability to take on new projects depends on the scope and timeline for a given document. clear communication, educating the client, and setting expectations and boundaries upfront are needed to ensure the project is completed according to the timeline, without compromising quality. in their presentation, ms byram, dr singleton, and dr chiavolini provided several strategies for assessing the ability to take on a project with a tight timeline, as well as several tools for creating high-quality documents within that timeline. stephany panlilio is a senior associate in medical writing at gilead sciences, inc. (foster city, ca) author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. author contact: stephany.panlilio@gilead.com * * * time to clock in: applying manufacturing best practices to consistently and efficiently produce high-quality documents speaker jenni pickett, phd, whitsell innovations, inc., chapel hill, nc mary ellis bogden, ba, whitsell innovations, inc., chapel hill, nc by stephany panlilio, ms regulatory writing and manufacturing have many commonalities. as with manufactured products, regulatory documents should be produced at a reasonable cost, completed per an agreed upon timeline, be fit for intended purpose, and should meet a set of corporate, legal, and customer standards. what can regulatory writers learn from advances in manufacturing processes? manufacturing best practice philosophies many modern manufacturing processes and principles came from the car manufacturer, toyota. the toyota way operates under 4 driving principles.1 these principles can also be applied to medical writing, as described below. • long-term philosophy – forward thinking. focusing on the processes used to create products or documents can help improve efficiency over time. • add value to the organization by developing your people and partners. in manufacturing and regulatory writing, ensuring that team members have the right skills is essential. • the right process will produce the right results. a robust process will ensure a high-quality product. • continuously solving root problems drives organizational learning. manufacturers and regulatory writers should develop and maintain a system to identify root causes and quickly address issues. good regulatory writing practice manufacturers of pharmaceutical products must adhere to good manufacturing practice (gmp) to mitigate risk. a robust gmp quality system includes training people; controlling starting materials and equipment; clearly defining manufacturing, packaging, and storage processes; testing for quality; and documenting each step. to produce high-quality documents, the following are necessary: trained people, correct source materials that are up-to-date and easy to use, defined processes for the writing and review cycles, a quality control review process, and documenting each step (figure). so, what would a theoretical good regulatory writing practice include? • developing the team by ensuring team members have the proper education, relevant experience, and knowledge of regulations and company policies can help to reduce the risk of human error. specific risks to your team can be evaluated by a gap analysis of critical skills. cultivating a growth mindset culture in which employees feel comfortable being noisy in their ignorance helps identify critical training needs. • creating a quality document profile, similar to the quality target product profile used in gmp, verifies the correct template, sources, interpretation, and team expectations are used for the document. using a storage management system prevents errors due to use of incorrect templates, outdated data, or irrelevant sources. http://www.amwajournal.org amwajournal.org 28session reports • protecting the data and text by using good data hygiene and limiting review cycles prevents transcription errors, incorrect data interpretation, and inconsistent text or messages within the document. reviewer fatigue and consistency errors can be reduced by waiting until the last review to write certain sections, such as the executive summary, synopsis, list of abbreviations, and summary of changes. • using risk-based quality control techniques can improve efficiency and ensure the most important areas in the document are correct. in gmp, critical quality attributes (cqas) are factors which would impact the overall quality of the product. identifying cqas in your document (ie, new data in an investigator brochure) can help your reviewer prioritize where to start. • recording the document development process in a tracker allows you to confirm you have followed all the key steps above and also see where improvements can be made. • reviewing your document development process periodically will allow you to address new risks as you discover them and improve efficiency and quality over time. gmp uses corrective action preventative action, a system in which root causes are identified, and solutions are proposed, verified, and implemented. identifying risks throughout regulatory document processes and finding ways to proactively mitigate them are imperative steps to creating high-quality documents. as regulations evolve and processes increase in complexity, implementing elements of a good regulatory writing practice provides a framework to focus on long-term investments in efficiency and quality of your documents by continually improving your people and processes. stephany panlilio is a senior associate in medical writing at gilead sciences, inc. (foster city, ca) author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. author contact: stephany.panlilio@gilead.com reference 1. liker, jk. the toyota way: 14 management principles from the world’s greatest manufacturer. mcgraw-hill; 2004. figure. elements of a theoretical good regulatory writing practice. http://www.amwajournal.org amwa journal / v36 n3 / 2021 / amwa.org 121 to be a good medical writer, you need to know something about mathematics. mathematics is the art of number, and numbers originated from words that were coined for the purpose of counting. however, some things can be counted, and some things cannot. count and noncount nouns discrete (as opposed to discreet!) means separate and distinct from other things. objects that are discrete can be counted. for example, you might count the number of apples in a basket, but you can never count the number of gasoline in a tank. for this reason, apple is a count noun, but gasoline is a noncount noun. so you can ask, “how many apples are in the basket?” but it would be ungrammatical to ask, “how many gasolines are left in the tank?” instead, you might ask, “how much gasoline is left in the tank?” many is used with count nouns; much is used with noncount nouns. some quantifiers (eg, all, any, enough, most, plenty of, some, and no) can be used with count or noncount nouns. however, there are some quantifiers that are used only with count nouns (eg, every, many, a few) and others that are used only with noncount nouns (eg, much, less, a little). if we want to talk about more than 1 of something in english, we use the plural form of the noun. the plural form is usually made by adding s or es to the end of the noun. however, there are many exceptions (see table on next page). these include some words of anglo-saxon origin, such as child/children, or woman/women, ox/oxen, goose/geese. note that many of the animal nouns that came from anglo-saxon are the same in singular and plural: fish, sheep, moose. many words of greek or latin origin that are important in medicine have irregular plural forms: bacterium/bacteria, corpus/ corpora, genus/genera, medium/media, species/species, stigma/stigmata. for some nouns with irregular plurals and some noncount nouns, a regular plural form has become commonplace or is used in specific circumstances. for example, water is a noncount noun. however, the word waters is used to refer to a watery geographical area (eg, the navigable waters of the united states) or in some poetic contexts. amniotic fluid, which surrounds the fetus in the womb, is also sometimes called waters. collective nouns a collective noun is a noun that refers to a group (set) of persons or things. for example, a swarm refers to a group of insects, and a choir refers to a group of singers. this raises problems of agreement with pronouns and verbs. should you refer to the collective as “it” or “them”? should you use the singular or plural form of the verb to refer to the collective’s actions? the answer depends on whether the individual members or the group is being emphasized: • the emergency department staff are trained in the latest resuscitation techniques (emphasizing individuals). • the hospital’s emergency department staff is the best in the city (emphasizing the group). note that british people are more likely than americans to use plural pronouns and verbs for collectives, such as businesses: • bloomingdale’s is having a sale on swimsuits (united states). • fenwick are having a sale on swimming costumes (britain). units of measure many things that cannot be counted can nevertheless be measured. to measure them, we need to find some unit of measure. for example, we can say “1 liter of water” or “2 bushels of wheat.” please notice the grammatical structure: the number counting and measuring laurie endicott thomas, ma, els / madison, nj 122 amwa journal / v36 n3 / 2021 / amwa.org singular plural addendum addenda, also addendums aircraft aircraft alumna alumnae alumnus alumni analysis analyses antenna antennae, also antennas antithesis antitheses apex apices, also apexes appendix appendices, also appendixes axis axes bacillus bacilli bacterium bacteria basis bases beau beaux, also beaus bison bison bureau bureaus, also bureau cactus cacti, also cactus or cactuses château châteaux, also châteaus child children codex codices, also codexes concerto concerti, also concertos corpus corpora crisis crises criterion criteria, also criterions curriculum curricula, also curriculums datum data deer deer diagnosis diagnoses die dice, also dies dwarf dwarves, also dwarfs ellipsis ellipses erratum errata faux pas faux pas fez fezzes, also fezes fish fish, also fishesa focus foci, also focuses foot feet, sometimes foot formula formulae, also formulas fungus fungi, also funguses genus genera, also genuses goose geese graffito graffiti grouse grouse, also grouses half halves hoof hooves, also hoofs hypothesis hypotheses index indices, also indexes lacuna lacunae larva larvae leaf leaves libretto libretti, also librettos loaf loaves locus loci louse lice man men matrix matrices, also matrixes medium media, also mediums memorandum memoranda, also memorandums minutia minutiae moose moose mouse mice nebula nebulae, also nebulas nucleus nuclei oasis oases octopus octopuses or octopodes offspring offspring opus opera ovum ova ox oxen, also ox parenthesis parentheses phenomenon phenomena phylum phyla quiz quizzes radius radii referendum referenda, also referendums salmon salmon scarf scarves schema schemata, also schemas self selves series series sheep sheep shrimp shrimp, also shrimpsa species species stigma stigmata stimulus stimuli stratum strata swine swine syllabus syllabi, also syllabuses symposium symposia, also symposiums synopsis synopses tableau tableaux, also tableaus thesis theses thief thieves tooth teeth trout trout, also troutsa tuna tuna, also tunasa vertebra vertebrae, also vertebras vertex vertices, also vertexes vita vitae vortex vortices, also vortexes wharf wharves, also wharfs wife wives wolf wolves woman women singular plural table. irregular english plurals athe former is typically used to refer to more than 1 individual of the same species, and the latter is typically used to refer to more than 1 species. amwa journal / v36 n3 / 2021 / amwa.org 123 is an adjective modifying the unit of measure. the unit of measure is a noun. the material being measured is now the object of a prepositional phrase (“of water”). if you are talking about some noncount noun that is being measured in this way, it will be treated as if it were a singular: 20 kilometers is (not are) a long walk. a unit of measure is arbitrarily defined; thus, the number associated with a measurement is meaningless unless the unit of measure has been defined, so you must carefully specify units of measure. units of measure typically relate to some natural phenomenon. for example, the inch was originally based on the width of a man’s thumb, and the foot was based on the length of a man’s foot. the main basis of the international system of units (si, for système international [d’unités]) is the meter. the si grew out of the metric system that was developed in revolutionary france. the meter was supposedly based on 1/10,000 of the distance from the north pole to the equator. other units of measure in the si were derived from the meter. a centimeter is 1/100th of a meter. a liter is 1,000 cubic centimeters, and a kilogram originally represented the mass of a liter of water. a newton is the amount of force to make a 1-kg object accelerate 1 meter per second per second. thus, measurements of force involve units of time as well as units of mass and distance. the si also includes many units that are important in physics and chemistry. a coulomb (c) is a measure of electrical charge, and an ampere (a) is a measure of electrical current. a candela (cd) is a measure of luminous intensity. a mole (mol) is a measure of the amount of a substance. a mole is defined as 6.02214076 × 1023 particles (eg, atoms or molecules). the number of particles in a mole is called avogadro’s number. our measurements of time were originally derived from the duration of a day. each day is divided into 24 hours, and each hour into 60 minutes, each minute into 60 seconds. the 60-minute hour and 60-second minute are legacies of the ancient mesopotamians, who used the number 60 as the basis of their number system. (the number 60 is the smallest number that can be divided evenly by every whole number from 1 to 6.) the ancients also divided a circle into 360°—partly because 360 can be evenly divided by so many different numbers and partly because 360 is close to the number of days in the year. (the lunar calendar has 355 days, and the solar calendar has 365 days). thus, the sun would advance roughly 1° along the ecliptic (its circular path relative to the background of stars) every day. whole and real numbers when we count objects, the result will be an integer. but when we measure the amount of something, as opposed to counting the number of items, the result would theoretically be a real number, along with a unit of measure. a real number is a number that can be expressed as some point along a number line. to express a measurement, however, we will end up using a rational number, as we will report only a limited number of digits after the decimal point. a rational number is one that can be expressed as a quotient or fraction of 2 integers. its decimal expansion, if it has one, will either terminate or end up repeating itself endlessly. for example, ¾ = 0.75 and ¹/³ = 0.33333…. (sometimes written 0.3, with the overbar representing the repeating decimal expansion). in contrast, irrational numbers have a decimal expansion that continues forever without repeating. examples include p (the ratio of the circumference of a circle to its diameter), e (euler’s number, which is useful for calculating compound interest), and the square root of 2. using different units (eg, miles vs kilometers) will yield a different number, so you have to include the units with the number. which unit of measure should you use? in scientific writing, you should use the si (meters, kilometers, kilograms, etc). but if you are writing for consumers in the united states, you should probably use the units that are familiar to consumers (feet and inches, miles, pounds and ounces, etc). accuracy, precision, and uncertainty accuracy refers to how well a measurement agrees with the truth. in contrast, precision refers to the agreement among repeated measurements (made under the same conditions). thus, a measurement that is accurate may be imprecise, and a measurement that is precise may be inaccurate. when choosing between methods of measurement, you often have to make a tradeoff between precision and accuracy. for example, a digital clock displays a precise, rational number, but that reading does not represent the true time. in contrast, an analog clock expresses time as a real number that cannot be read precisely. both inaccuracy and imprecision contribute to uncertainty. all measurements, and all quantities calculated from measurements, will have some degree of uncertainty. the degree of uncertainty can be expressed in various ways. one is by showing only a limited number of significant digits. for example, a reported value of 3.5 implies that the actual value is probably somewhere between 3.45 and 3.55. in contrast, a reported value of 3.50 implies that the actual value is probably somewhere between 3.495 and 3.505—a much narrower range. you can also express the uncertainty in units of measure or as a percentage of the total value: 25.2 ml ± 0.05 ml can be expressed as 2.52 ml ± 0.2%. 124 amwa journal / v36 n3 / 2021 / amwa.org even when we are dealing with counts, such as the number of people who live in a city, we sometimes have to deal with uncertainty. as a result, we may have to settle for an approximate number, such as when we say that the population of new york city was 8.40 million in 2018. nor should we report too many digits after a decimal point: we shouldn’t report a value as 5.38761 when the precision of the value really only lets us say 5.4. fractions and percentages a fraction is made by division. the top number (numerator) is divided by the bottom number (denominator). a percentage is a fraction whose denominator is 100. whenever you encounter a percentage or any other fraction, try to figure out what the numerator and denominator represent. for example, the forced expiratory volume in 1 second (fev1) is the amount of air that a patient can exhale in 1 second and is measured in liters. this value can then be divided by the full forced vital capacity (fvc), which is the total amount of air that the person can exhale after taking the biggest possible breath, to yield the tiffeneau-pinelli index (fev1/fvc), which is a unitless rational number. the fev1 and fvc can also be expressed as a percentage of the values that are predicted, given the patient’s sex, age, height, and race. when talking about values that are already expressed in percentages, be cautious about using percentages to express changes. for example, if a value increased from 10% to 20%, that’s an increase of 10 percentage points, not 10% (it’s a 100% increase; see percentage increase and decrease). negative numbers and vectors addition is the arithmetic operation that originally represented adding objects to a collection. its opposite is subtraction, which originally represented the removal of objects from a collection. if you have 5 apples in a basket, you cannot remove more than 5 apples from that basket. but if you have $100 in your checking account and write a check for $200, you will end up with a balance of −$100 in your account. you would have to deposit $100 in the account to bring the balance up to 0. accountants sometimes use parentheses instead of a minus sign to indicate negative numbers. addition and subtraction are often represented by rightward or leftward movement, respectively, on a number line. thus, addition and subtraction involve not just quantity but direction. in mathematics, a geometrical object that has a direction as well as a magnitude is called a vector. a line is one-dimensional, so there are only 2 directions. in contrast, a map is two-dimensional, which allows for an infinite number of directions. if i walk 1 block north, then 1 block west, then 1 block south, then 1 block east, i will have walked a distance of 4 blocks, but i will end up back where i started. human beings can easily think in terms of 4 dimensions: the 3 dimensions of euclidean geometry plus time. however, mathematicians often deal with problems that involve more than 4 dimensions. this allows them to develop a mathematical model of relationships among many variables at the same time. exponents and logarithms exponentiation is when you multiply a base number (b) by itself n number of times (b n). for example, 23 = 2 × 2 × 2 = 8. the n is called an exponent, and we often say that b has been raised to the nth power. if n = 2, we say that the base is squared. if n = 3, we say that the base is cubed. medical communicators often deal with powers of 10: 10 = 101, 100 = 102, 1,000= 103, 10,000 = 104, and so on. however, any real number could serve as the base or the exponent. the use of exponents can turn a multiplication problem into an addition problem: if 2 exponential expressions have the same base, you can multiply the 2 by adding their exponents: 102 × 103 = 105. to divide, you subtract the exponents: 105 ÷ 103 = 102. any nonzero number divided by itself is 1; therefore, b 0 = 1. you can also have negative exponents: b -n = 1/b n. you can also raise negative numbers to any power. note, however, that if you raise a negative number to an even power (eg, −1 × −1), the product will be a positive number. if you raise it to an odd power, the result will be a negative number (eg, −1 × −1 × −1 = −1). in medical writing, you will often see powers of 10, especially in scientific notation: 5.23 × 105 = 523,000, but 5.23 × 10−5 = 0.0000523. sometimes e notation is used to express powers of 10. 5.23e5 means 5.23 × 105, and 5.23e−5 means 5.23 × 10−5. a logarithm is the inverse function of exponentiation. if b n = x, then n = logb(x). because 23 = 8, log2(8) = 3. because exponents can be negative, you can have negative logarithms, which represent the inverse of a number. because ½ is the inverse of 2, the log2(½) = −1. likewise, the log10(¹⁄10) = −1 (figure on next page). some units of measure are based on a logarithmic scale. for example, ph is based on the negative of the base-10 logarithm of the activity of the h+ ion (as measured in moles per liter). ph= –log10 (ah +) = log10 a solution of pure water has hydrogen activity of 1 × 10−7 mol/l. the reciprocal of that is 1 ×107, or 107; log10(107) = 7. so the ph of pure water is 7. water with a ph of 6 would have a hydrogen activity of 1 ×10−6 mol/l, which is 10 times as many hydrogen ions as in pure water! 1 ah +( ) amwa journal / v36 n3 / 2021 / amwa.org 125 base-10 logarithms are used so often that they are often just written as log(x). the natural logarithm, abbreviated ln(x), has euler’s number (e) as its base. euler’s number is an irrational number that is useful in many different areas of mathematics. medical writers should be aware that viral load is often expressed in base-10 logarithms. i once edited a news article that described a patient as having a viral load of 5 copies/ml. that value was dubious: a value that low had to be below the limit of detection of any available assay. when i looked at the source material, i found out that the patient’s reported viral load was actually 5 log10 copies/ml, which meant 100,000 copies/ml. big difference! stevens’ taxonomy of measurement medical writers must be aware that numbers do not always represent counts, or some point along a number line, or a vector. to explain this problem, stanley smith stevens explained that there are 4 types of measurement scale.1 • nominal— a nominal scale is used when items or individuals are being assigned to groups that do not overlap. such groups may be labeled with numbers: group 1, group 2, group 3. however, these numbers are simply being used as labels and do not express any sort of quantity. • ordinal— an ordinal scale is used when items or individuals are being ranked according to how they compare with each other in terms of some property. for example, the runners in a race will be ranked first, second, third, and so on, according to how fast they ran. however, these ordinal numbers merely show rank. they do not use units of measure, and they do not show absolute quantities or ratios. for example, the second-place finisher in a race was faster than the fourth-place finisher—but not necessarily twice as fast. the wong-baker faces pain rating scale2 is an ordinal scale. so are the likert scales that are used in opinion research (eg, 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, 5 = strongly agree). a logarithm is the inverse function of exponentiation. if bn = x, then n = logb(x). since 23 = 8, log2(8) = 3. since exponents can be negative, you can have negative logarithms, which represent the inverse of a number. since ½ is the inverse of 2, the log2(½) = −1. likewise, the log10(¹⁄₁₀) = −1 (figure 1). some units of measure are based on a logarithmic scale. for example, ph is based on the negative of the base-10 logarithm of the activity of the h+ ion (as measured in moles per liter). 𝑝𝑝𝑝𝑝 = −𝑙𝑙𝑙𝑙𝑙𝑙!"(𝑎𝑎#!) = 𝑙𝑙𝑙𝑙𝑙𝑙!" , 1 𝑎𝑎#! . a solution of pure water has hydrogen activity of 1 × 10−7. the reciprocal of that is 1 ×107, or 107; log10(107) = 7. so the ph of pure water is 7. water with a ph of 6 would have a hydrogen activity of 1 ×10−6, which is 10 times as many hydrogen ions as in pure water! figure 1. logarithms are the inverse function of exponentiation: if bn = x, then n = logb(x). exponentiation allows you to raise any real number (any point along a number line) to any real power. note that x0 always equals 1, and x1 always equals x. for this reason, logb(0) is always 1 and logb(1) is always b, regardless of the value of b (i.e., regardless of the base of the logarithm). a negative exponent represents the inverse of a number (e.g., 2−1 = ½). thus, a negative logarithm equals the logarithm of the inverse of the value: log2(½) = −1 and −log2(½) = 1. courtesy of richard f. lyon via wikimedia commons. base-10 logarithms are used so often that they are often just written as log (x). the natural logarithm, abbreviated ln (x), has euler’s number (e) as its base. euler’s number is an irrational number that is useful in many different areas of mathematics. medical writers should be aware that viral load is often expressed in base-10 logarithms. i once edited a news article that described a patient as having a viral load of 5 copies/ml. that value was dubious: a value that low had to be below the limit of detection of any available assay. when i looked at the source material, i found out that the patient’s reported viral load was actually 5 log10 copies/ml, which meant 100,000 copies/ml. big difference! figure. you can raise any real number (b) to any real power (y), even negative and fractional powers. the logarithmic function is the inverse function of exponentiation: if by = x, then y = logb(x). the graph shows the value of logb(x) for x>0 and some nonzero values of b. the value of log0(x) is undefined; but for b≠0, logb(1)=0 and logb(b)=1. also, logb(x) = −logb(1/x). thus, the value of logb(0) is undefined but approaches −∞ as x approaches 0. the logarithm of a negative number is not a real number but involves a complex expression. graph courtesy of richard f. lyon via wikimedia commons. percentage increase and decrease the formula for calculating percentage increase and decrease is: percentage increase = [(final value − starting value)/ |starting value|] × 100 if you weigh 50 kg and gain 100 kg, that’s a 200% increase in weight: [(150 – 50)/50] × 100 = 200% but if you then lose that 100 kg, that’s only a 67% decrease in weight: [(50-150)/150] × 100 = −67% fold increase and decrease a fold is a ratio between 2 values. the formula for calculating fold increase is: fold change (for increases) = final value/starting value. if you weigh 50 kg and gain 100 kg, then that’s a 3-fold increase in weight: (150/50) = 3 a fold decrease is calculated as follows: fold change (for decreases) = −(starting value/ final value). if you weigh 150 kg and lose 100 kg, then that’s a −3-fold change (3-fold decrease) in weight: − (150/50) = −3 however, some people use the fold increase formula for calculating fold decreases. as a result, they would describe a change from 150 kg to 50 kg as a 0.33-fold decrease in weight. so if you see someone express a fold decrease, make sure you know what they really meant! 126 amwa journal / v36 n3 / 2021 / amwa.org • interval— an interval scale not only orders items or individuals according to some characteristic but also establishes equal intervals between the units of measurement. this allows you to do some mathematical operations, such as calculating averages. however, the 0 point may be meaningless. for this reason, the measurements cannot be expressed in ratios. for example, in the celsius or centigrade scale, 0° was set to represent the freezing point of water, whereas 100° was set to represent the boiling point of water. however, the fahrenheit scale sets 0° at a different point and uses different intervals. water that is at 40 °c (104 °f) is warmer than water at 20 °c (68 °f), but it is not twice as warm! so don’t express such a change in temperature as a multiple or a percentage. • ratio scale— a ratio scale has a meaningful 0 point as well as equal intervals. this allows you to calculate ratios. for example, you can say that 1 thing weighs twice as much as another, or that something costs twice as much as something else. conclusion so if you are being asked to report on the meaning of the outcome measures used in a study, you must present the numbers accurately and specify the units (if any). you must also think about what those numbers really mean! for example, it is an established convention that the 0 point on a psychological or educational measurement is arbitrary and may be meaningless. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: www.nottrivialbook.com; lthomas521@verizon.net references 1. stevens ss. measurement, statistics, and the schemapiric view. like the faces of janus, science looks two ways—toward schematics and empirics. science. 1968;161(3844):849-856. 2. wong dl, baker cm. pain in children: comparison of assessment scales. pediatr nurs. 1988;14(1):9-17. a career in medical communication: steps to success learn about the skills and attributes needed to be a successful medical communicator and discover opportunities in the field. www.amwa.org/career_steps http://www.nottrivialbook.com mailto:lthomas521@verizon.net http://www.amwa.org/career_steps 86 amwa journal / v36 n2 / 2021 / amwa.org introduction freelance medical writers and editors who have long-term relationships with their ideal clients enjoy many benefits.1 among them are increased productivity and efficiency, financial stability, and peace of mind. when the expertise, services, availability, and interests of the freelancer match the needs and goals of a new client, the relationship often clicks and the project proceeds smoothly. in such cases, the characteristics of the freelancer and the client likely match in 4 categories: type and topic of project, required time frame, business agreements, and personal compatibility (figure 1). ideally, the expertise and interests of the freelancer should match the needs of the client, and the freelancer has sufficient availability to perform the services within the client’s requested time frame. the business agreements and fees are fair to both parties, and the freelancer and the client have good rapport. marketing, including advertising and social media, is a common way to acquire clients that desire and need your services,2,3 but “a” client isn’t necessarily an “ideal” client. the trick is to find the clients that will be ideal for you. the following 3 exercises will help you build your business by identifying clients that may be ideal for you. for clarification, the term “suitable clients” refers to clients that match many of your preferred characteristics, whereas “preferred clients” match most of your preferred characteristics and avoid most of the negative attributes. “ideal clients” match all your preferred characteristics and avoid all the negative attributes. once you have begun working with them, you can nurture them into long-term relationships by using the suggestions outlined in our article “16 tips for nurturing clients into long-term relationships.”1 exercise 1. assess your strengths, preferences, and interests exercise 1 focuses on recognizing your strengths and preferences with respect to the types of deliverables, writing styles, subject areas, and project responsibilities. it will also help identify your desired areas for expanding your current range of services. examples of many deliverables, writing styles, subject areas, and medical writing and project management responsibilities are listed in table 1. consider selecting and/ or expanding the niches to suit your situation in the exercise 1 worksheet to consolidate the strengths of your freelance services and goals. freelancers who know their strengths and preferences have a better chance of getting the work they like and want to do and have a better chance of finding potential clients who need the services they provide. katherine molnar-kimber, phd1; brian bass, mwc2; thomas drake, ma, cmpp3; and nicole cooper4 / 1kmk consulting services, kimnar group llc, worcester, pa; 2bass global, inc, fort myers, fl; 3director, global outcomes group, reston, va; 4cooper johnson communications llc, gladstone, nj practical matters three exercises to identify ideal clients you can nurture into long-term relationships figure 1. the 4 main aspects of freelancer–client relationships usually align in collaborative, productive business deals, which can be nurtured into long-term freelancer–client relationships. amwa journal / v36 n2 / 2021 / amwa.org 87 exercise 2. identify suitable client types and preferable characteristics table 2 lists many types of clients that hire freelancers. exercise 2 focuses on identifying the types of clients with whom you want to work: those who complement your strengths, benefit from your expertise, and match your working style and interests. on the exercise 2a worksheet, identify clients that need your expertise and abilities, whether that is in a particular type of deliverable, writing style, or subject area. in general, go with what you know because it is more time-consuming and challenging to produce your best work when you also have to learn as you go. this exercise will also help you identify the specific preferred client characteristics. to spur thinking about the characteristics of your ideal client, we have listed several in table 3. consider compiling your own list of ideal characteristics, too. using the exercise 2b worksheet, compile a list of 10 potential clients that hire freelancers and would belong to the very strong-match category you identified in exercise 2a. table 1. examples of medical writing deliverables, writing styles, subject areas, and project management responsibilities areas of strength and experience examples deliverables • regulatory documents • manuscripts for peer-reviewed journals • abstracts, posters, podium presentations • grants • slide decks • newsletters • promotional materials (eg, white papers, websites, branded presentations, video scripts) • educational materials for health care professionals (eg, cme, guidelines) • needs assessments for cme • training materials for sales representatives • educational materials for patients or the general public (eg, lay summaries, narratives, health news) writing styles • prescriptive (eg, regulatory documents) • scientific (eg, manuscripts, video abstracts, educational materials) • promotional (eg, websites, branded slide decks) • plain language (eg, patient/caregiver materials) subject areas • therapeutic areas • rare diseases • pharmaceuticals • devices • pharmacoeconomics • managed care • modalities (eg, biologics, gene therapy) project responsibilities • writing clear concise content • annotating references • formatting references and documents • project management • tables and figures • collaboration with scientific graphic designers • incorporating revisions and compiling feedback from multiple stakeholders cme, continuing medical education. exercise 1 worksheet. assess your strengths, preferences, and interests to match to your ideal clients area degree of experience areas of interest high moderate low deliverables writing styles subject areas project responsibilities use the examples in table 1, and your own ideas, to list the areas in which you have experience and interest. practical matters 88 amwa journal / v36 n2 / 2021 / amwa.org consider ways to meet their representatives, such as through professional organizations or linkedin. as one strategy to expand your client base, consider marketing your skills for specific deliverables and therapeutic areas to these identified potential clients with preferred or ideal characteristics. there is nothing better than doing work you love for clients you love. exercise 3. identify the aspects of projects and freelancer–client relationships you prefer to avoid or to negotiate in exercise 1, you identified your preferred types of deliverables, writing styles, subject areas, and project responsibilities. in exercise 2, you identified the types of clients with whom you want to work, your specific preferred client characteristics, and 5 to 10 clients that match these attributes. knowing what you do not like is just as important for helping you find and work with ideal clients: hence, exercise 3. challenges can arise in any freelancer–client relationship, and knowledge about which you prefer to avoid or renegotiate can help relieve stress. table 4 lists some challenging aspects of projects and freelancer–client relationships many freelancers may want to avoid and potential strategies that may help you address or prevent these issues. consider creating your own list of client attributes you would like to avoid by combining your own ideas with the attributes in table 4 on the exercise 3 worksheet. knowing the aspects of projects and freelancer–client relationships you prefer to avoid, clarify, or negotiate will give you the time and energy to find and work with ideal clients on the projects you love. summary nurturing long-term relationships with ideal clients can help freelancers increase productivity, efficiency, financial stability, and peace of mind. every prospective client presents an opportunity to explore working relationships and the fit of the freelancer’s services with the expected deliverables. when freelancers are clear about the types of work they like and can do well, their available bandwidth in the requested time frame, and the characteristics of their ideal clients or working relationships, freelancers can more quickly assess whether to proceed with the potentially ideal client. thus, freelancers can focus their marketing efforts on attracting clients aligned with their expertise and interests. the 3 exercises recommended table 2. examples of types of clients that hire medical writers types of clients • pharmaceutical companies • biotech companies • hospitals • academia • publishers • professional societies • medical communication companies • medical education companies • medical advertising agencies • public relations agencies exercise 2a worksheet. identify suitable client types and preferable characteristics very strong match strong match match use the examples in table 2, and your own ideas, to list the types of clients that match your strengths, preferences, and interests exercise 2b worksheet. assemble a list of names of companies with appropriate department(s) that strongly match your interests, expertise, and preferred working style very strong match contact(s) comments compile lists of actual client names that fit the very-strong-match category and identify ways to meet representatives. table 3. examples of client characteristics preferred by freelancers preferred client characteristics • recognizing and valuing your expertise • compensating you accordingly • paying your invoices on time • offering projects in your preferred writing style(s), formats, and topics • providing manageable timelines • offering contracts that protect both you and the client and allow you to work with your preferred software and hardware on your preferred schedule • being professional and pleasant exercise 3 worksheet. identify the aspects of projects and freelancer–client relationships you want to avoid i want to avoid or negotiate . . . 1. 2. 3. 4. 5. use the examples in table 4, and your own ideas, to list the aspects of projects and freelancer-client relationships you want to avoid or negotiate, so you have more time to find and work with ideal clients. practical matters amwa journal / v36 n2 / 2021 / amwa.org 89 table 4. examples of less desirable client characteristics and potential strategies to handle challenging situations aspects of projects and freelancer–client relationships to consider whether to avoid strategies to handle challenging situations • chronically tight timelines • clarify expectation of scientific depth, goals, audience, and length of deliverable. • offer a realistic timeline. • turn down the project. • chronic project scope creep without compensation • write detailed specifications for the project. • for major scope creep, ask for increased compensation. • for repeat clients with this attribute, consider a quote that includes the relevant percentage of scope creep for that client. • lack of boundaries (eg, emails/phone calls at night or on weekends or holidays) • clarify times when you’ll check emails. • lack of consideration (eg, scheduling teleconferences or videoconferences without first asking for your availability) • if unavailable, then state it. usually, the client will reschedule the call as needed. • if you know about an upcoming meeting to be scheduled, provide available dates and times proactively. • provide dates for other commitments (meetings and vacation) ahead of time. potential contract issues strategies to handle challenging situations • restriction of trade with any and all of company’s clients at all their departments and all locations • request revision of restriction of trade to the departments and locations of agency’s clients for which you actually work or interact with under the agency’s supervision. most companies will agree. • request that knowledge of their clients be sent on a need-to-know basis. • contracts that severely limit your ability to work in broad topics with other clients (ie, restrictive of trade in modality or broad therapeutic area such as oncology) • negotiate a restriction for a narrower field (eg, pd1 inhibitors in non– small-cell lung cancer). • offer to accept restriction in exchange for retainer fee. • contract provides many subjective descriptions before payment, but no definitive milestones (eg, submission to journal) • request 20%-30% deposit before beginning project. • in the transfer of copyright clause in the contract, add the phrase “after payment of all invoices.” most companies will accept the change. • no obligation to protect confidentiality of freelancer’s confidential information (eg, ein, bank account information) • request revision and most companies will agree as they already do it. • project specifications do not yet include the responsible party and the procedure for obtaining published articles behind a paywall (implied freelancer’s responsibility) • ask for clarification, most companies will clarify the responsible party and procedure in their contract or statement of work. ein, employer identification number; pd1, programmed cell death 1. in this article will enable you to assess your strengths, preferences, and interests; identify suitable client types and their preferable characteristics; and identify the aspects of projects and freelancer–client relationships to avoid or negotiate. by doing so, you will be well on your way toward finding the clients that are right for you. author declarations and disclosures: the authors report no commercial associations that may pose a conflict of interest in relation to this article. author contact: molnarkimber@kimnargroupllc.com references 1. molnar-kimber k, drake t, bass b, cooper n. 16 tips for nurturing clients into long-term relationships. amwa j. 2020;35(4):186-189. 2. demilto l. the mighty marketer: your guide to making more money as a freelance medical writer. booklocker.com, inc; 2015. 3. bly rw. bob bly's guide to freelance writing success: how to make $100,000 a year as a freelance writer and have the time of your life doing it. filbert publishing; 2016. practical matters mailto:molnarkimber@kimnargroupllc.com contents v36 n2 summer 2021 95 86 72 57 58 63 64 72 79 82 from the editor first word feature amwa-emwa-ismpp joint position statement on medical publications, preprints, and peer review calendar of meetings research a brief history of the covid-19 pandemic and current efforts to combat it � jeanette towles feature science series intersections of severe acute respiratory syndrome coronavirus 2, coronavirus disease 2019, and the cardiovascular system � jennifer l. busch practical matters little-known tips for using microsoft word for clear writing � monisha arya and sheeva azma freelance focus brian bass, lori de milto, cathryn d. evans, and phyllis minick what are the pros and cons of different types of medical writing (ie, pharmaceutical/biotech, regulatory, managed-care industry, the publishing industry, public relations, lay press, public health, nonprofits, and hospital/university)? have you offered daily rates to your clients? if so, what are the situations in which daily rates have worked best for you? contents editor-in-chief michael g. baker, phd managing editor jennifer workman section editors around the career block lauren mcmahon, pharmd media and technology tara ann cartwright, phd practical matters qing zhou, phd, els regulatory insights jennifer bridgers, ms, mwc science series paul c. dolber, phd social media jennifer minarcik, ms statistically speaking thomas m. schindler, phd everyday ethics julie ravo, ba, ma members matters govindi (jaya) samaranayake, phd freelance focus ruwaida vakil, msc regular contributors freelance focus brian bass, mwc melissa l. bogen, els sherri bowen, ma, els lori de milto, mj cathryn d. evans gail v. flores, phd phyllis minick in the service of good writing laurie endicott thomas, ma, els editor at large haifa kassis, md editor emeritus lori l. alexander, mtpw, els, mwc editor in memoriam ronald j. sanchez 2020–2021 president gail v. flores, phd 2020–2021 board liaison r. michelle sauer gehring, phd, els 2020–2021 staff liaison shari rager, ms, cae executive director susan krug, ms, cae graphic designer amy boches, biographics editorial office: managingeditor@amwa.org. instructions for authors available at: www.amwa.org/journal. advertising: contact marketing@amwa.org or (240) 239-0940. all advertising is subject to acceptance by amwa and should be for products and services relevant to professional medical communicators. amwa is not responsible for the content of advertising and does not endorse any advertiser or its products or services. subscription: the amwa journal is published quarterly. subscription is included with amwa membership. nonmember subscriptions cost is $75 per year. contact: american medical writers association, 30 west gude drive, #525, rockville, md 20850-4347. phone: (240) 238-0940; fax: (301) 294-9006; email: amwa@amwa.org. the amwa journal is in the mla international bibliography and selectively indexed in the cumulative index to nursing and allied health literature (cinahl) print index and the cinahl database. the opinions expressed by authors contributing to the journal do not necessarily reflect the opinions of amwa or the institutions with which the authors are affiliated. the association accepts no responsibility for the opinions expressed by contributors to the journal. ©2021 american medical writers association. all rights reserved, worldwide. issn 1075-6361 amwa journal mission statement in support of the mission of the american medical writers association (amwa) and to advance the broader profession, the amwa journal publishes content that reflects the interests, concerns, and expertise of medical communicators. its purpose is to inform, inspire, and motivate medical communicators. m o r e v36 n2 / 2021 85 creative writings .death* � morgan katz 86 practical matters three exercises to identify ideal clients you can nurture into long-term relationships � katherine molnar-kimber, brian bass, thomas drake, and nicole cooper 90 everyday ethics considerations for developing ethical biomedical grant proposals for the national institutes of health � chris s. gandhi and nancy linford 94 amwa news from the president � gail v. flores harold swanberg distinguished service award � elise eller 2021 john p. mcgovern award recipient: stacy l. christiansen, ma � gail v. flores 2021 walter c. alvarez award recipient: harriet washington � sarah dobney virtually amazing: amwa2021 � sarah dobney f e a t u r e 30 amwa journal / v36 n1 / 2021 / amwa.org because of the significance this topic poses for medical writers and editors, i am pleased to continue our planned series of articles about predatory publishing for the amwa journal. interview with amwa we welcome simon linacre, an expert on predatory publishing and the director of international marketing & development at cabells scholarly analytics (see box). simon had previously spent 15 years at emerald publishing specializing in journal acquisitions, open access, and business development. he holds a diploma in journalism and master’s degrees in philosophy and international business. in 2020, he was coopted to serve his first term as a trustee for the committee on publication ethics. amwa: from 2003 to 2018, you worked at emerald publishing, which held a unique portfolio of journals related to librarianship, as they prepared to move toward providing open access. how did you connect with cabells during that period? linacre: during my career at emerald publishing, i was the contact for citation, journal rankings, and indexing for cabells’ lists of journals related to library titles. like other commercial publishers at that time, emerald also faced the difficulties of trying to move from a subscription-based model to the open access free-to-read model. in 2015, i oversaw this launch in response to what the united kingdom mandated for all commercial publishers. in the transition to an open access route, all sorts of technical issues can arise for publishers. for example, a few discovered that one of their journals had been hijacked by a predatory publisher who had copied and pasted the publisher’s website using a slightly different url. no link worked except the “pay here” button that led directly to the predator’s site. such examples highlight the tactics of predatory publishers. one must be extremely careful and remain on the lookout. amwa: for background, can you describe cabells’ initial concept of creating a list that would help critically assess scholarly journals? linacre: in 1978, management professor david cabell had the idea to establish a verified and verifiable list of journal information that would serve as a time-saving guide for researchers, tenure committees, and doctoral students who were searching to find the right journal to publish their scholarly business research. the first list included important factors for tenure, such as times to review, accept, and publish in a reputable journal in the management field. this original directory of recommended business journals expanded in the early 2000s to include journals from the fields of social sciences and computer sciences. this would later evolve into what was then called the whitelist (renamed now as journalytics), which indexed across all areas except medical, engineering, and some humanities. within the next few months, journalytics will add a new medical list that indexes data and analytics for more than 5,000 more journals. amwa: as open access began to gain momentum in the early 2000s, a group of predatory publishers emerged who would exploit the gold open access model with aims to collect article processing charges (apcs) at the expense of quality. tell us about cabells’ transition in expanding the directory to add predatory journals. cabells scholarly analytics is a force of knowledge against predatory publishing— an interview with simon linacre mary kemper, bs / medical writer, mayfield clinic, cincinnati, oh background on cabells for more than 40 years, cabells scholarly analytics (https://noaa.cabells.com/) has achieved an exemplary reputation for analytics across 18 disciplines in more than 11,000 international journals. in 2015, cabells began their work to vet predatory journals by establishing analytics for this group of open access journals. in 2017, they launched a multidisciplinary journal blacklist of an initial 4,000 predatory journals that met 60 “behavioral indicators” that identified violations related to integrity, peer review, metrics (eg, impact factor), and publication and business practices. today, cabells offers subscriptions to its predatory reports (formerly the blacklist) with 14,000 titles and to its journalytics (formerly the whitelist) with 11,000 titles—soon to expand with the addition of more than 5,000 medical journal titles. https://noaa.cabells.com/ amwa journal / v36 n1 / 2021 / amwa.org 31 linacre: by 2015, cabells began their product development to vet predatory journals and create a new list using a unique set of analytics judged by an internal review team. as part of this effort, they convened a conference panel in boston in 2017 on the subject of predatory publishing; i was part of the panel of experts that also included jeffrey beall (see sidebar). it was sheer coincidence that beall removed his list early in 2017 and cabells launched their whitelist and blacklist several months later, with an initial listing of 4,000 journals. amwa: the specific criteria are clearly defined in predatory report criteria v1.1, with violations rated from minor to moderate or severe. can you explain how these criteria are valuable in helping researchers and medical writers avoid predatory journals and in understanding the depth of cabells’ undertaking? linacre: the initial multidisciplinary journal blacklist (renamed now as predatory reports) included predatory journals that violated more than 60 criteria, called “behavioral indicators,” used to ascertain the legitimacy of a publication. these metrics indicate violations in issues of integrity, website, publication and business practices, and indexing and metrics. today, cabells’ journalytics indexes 11,000 scholarly titles, and its predatory reports lists nearly 14,000 predatory journals from all academic disciplines, with medical biological sciences and medicine forming a large proportion of the total. predatory reports is a searchable database that identifies the specific types of predatory behaviors that cabells specialists identify and analyze among the behavioral indicators. like journalytics, predatory reports provides basic background on the journals, such as publisher, website, and geographic origin, but it uniquely provides a misconduct report about specific violations. cabells also tracks new trends in deception or other predatory practices and welcomes researchers to alert them on any new suspect journal. amwa: from your studies at university to your focus in open access at emerald publishing and your initial connection with cabells, how did your talents and experience coalesce toward 2018 when you joined cabells’ global effort against predatory publishing? linacre: at university, i developed my critical faculties, sometimes being extremely cynical and doubtful. however, today, i use this experience to identify what’s legit and what’s not in helping researchers navigate through this period when publisher launches are almost exclusively open access. given my positive 15-year relationship with cabells, i reached out to them when i left emerald publishing. the timing was right. cabells was a north american-focused organization with most of its customers based in the united states. however, they were looking to internationalize, creating more business in the united kingdom, europe, and elsewhere. we began our product development initiatives and a thought leadership program, such as our educational blog, the source, and educational seminars for researchers. amwa: your blog post, “cabells’ top 7 palpable points about predatory publishing practices,” highlights the gravity of the issue: “over 4,300 journals claim to publish articles in the medical field (this includes multidisciplinary journals) – that’s a third of the journals in predatory reports.” what are some of the strategies in 2021? linacre: cabells started at the other end of the spectrum in business. until recently, the journalytics database did not cover medical journals, although they have always been a significant part of the predatory reports list. medical journals were not initially included because medical areas are huge and dynamic: they have the most journals and a rapid, high churn of journal articles. customers had great demand for us to create a biomedical product that would list medical journals; they had many questions, especially if a particular journal was on a list. finally, cabells was ready to tackle the daunting field of medicine: it would necessitate its own team of experts, creation of its unique database, and its own unique set of criteria and analytics. toward this aim, in 2018, we assembled our team of auditors to annually review all titles in journalytics and to guide our product development in the field of medicine. for journalytics, publishers push their titles to cabells for review and listing. however, we are very judicious before assigning a title to one list or the other. a common reason for a journal not to make it into journalytics is that the journal has not been publishing long enough or is too niche. at least 1 or 2 years of citation data, robust peer review, and a minimal level of activity are needed for our team to ensure the title legitithe term “predatory publisher” was coined by university of denver, colorado, librarian jeffrey beall in 2010 to describe this academic publishing model that exploited the gold open access model. in 2012, he began beall’s list, which provided free lists and reports of potential or probable predatory journals and publishers; it was based on an initial set of 26 criteria that he used to define predatory behaviors (eg, deceptive business practices, lack of ethics and integrity, corruption to the scholarly literature). when beall removed his blog in 2017, he was an expert on the explosive growth of these predatory publishers and tirelessly devoted to protecting the research community while working full-time as a librarian. he was controversial for his criticisms of the social open access movement and for shortcomings of his blacklist approach. nonetheless, his blog’s absence left a huge gap in scientific communication. there is only one legitimate archived beall’s list (https://beallslist.net/ accessed october 12, 2020). https://beallslist.net/ 32 amwa journal / v36 n1 / 2021 / amwa.org mately belongs in journalytics (https://www2.cabells.com/ selection-policy2). with low citation, niche journals may never be listed on the web of science. amwa: what about a greylist? linacre: many of our customers have asked about this possibility. given that most journals do fall into this in-between area, a greylist would be larger than the combination of journalytics and predatory reports. therefore, more than 30,000 journal titles would not meet criteria for being either scholarly or predatory and would fall into this grey zone! amwa: the medical area is more likely to attract predatory publishers. what global innovations are on cabells’ horizon? linacre: for predatory publishers, the fields of medicine and biological sciences are the most fertile areas because they can charge higher apcs and take advantage of the publish-or-perish, high-churn culture. for cabells, these fields are also the most difficult to characterize. therefore, we are working on new products that use complex design technologies to bring radical changes in safeguarding scholarly publishing. for example, rather than a list analogue, a university system might red flag any author interacting with a predatory journal for research or submission. amwa: simon, thank you for sharing your perspective and expertise on cabells’ commitment. any final points that you would like to make? linacre: compared with scholarly biomedical journals, predatory journals often include a country or origin in their title, advertise as a generic multidisciplinary field, and take advantage of the publish-or-perish culture. they especially target post-doctoral students or faculty seeking tenure. i always advise authors to do their own research and weigh each journal against a set of selection criteria, such as those from our lists. cabells is working toward developing other products that may someday cover a portion of the costs related to producing these scholarly analytics so that they can become more widely available. in closing research your research. researchers face the need to publish their research, and increasingly, these publications will be in open access format, as promoted by national and international initiatives such as plan s. researchers must dig deep, and they have all the skills to do it. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: mkemper@mayfieldclinic.com amwa live webinars tools, tips, and tricks for medical communicators. www.amwa.org/events only $20 for members can’t attend a live webinar? you won’t miss out! all registrations for live webinars include access to the recorded video in amwa online learning. https://www2.cabells.com/selection-policy2 https://www2.cabells.com/selection-policy2 mailto:mkemper@mayfieldclinic.com amwa journal / v36 n4 / 2021 / amwa.org 173 successful vendor–sponsor relationships, such as those between a contract research organization (cro) and pharmaceutical company, assure and accelerate regulatory success for new products. often, however, this relationship fails, which delays approval and, in turn, costs the pharmaceutical company money by shortening the market time of the product. demetrius carter, mba, pmp, rac-us, shared insight on this relationship at the amwa carolinas 2021 spring conference by providing methods of assuring and accelerating regulatory success for pharmaceutical companies, reasons that cro–pharmaceutical company relationships fail, successful mitigation strategies, case studies illustrating failed relationships, and, finally, techniques to strengthen and transform the cro–pharmaceutical company relationship into a strategic partnership. mr carter is a clinical development executive with over 20 years of drug development experience in the pharmaceutical and medical device industries. he is the senior vice president for regulatory services at certara synchrogenix, where he is responsible for their regulatory writing, strategy, and operations teams. his presentation was entitled “‘i can help you if you would just let me!’: best practices in overcoming a challenging sponsor.”1 amwa: how can cros assure and accelerate regulatory success for pharmaceutical companies? carter: to assure and accelerate regulatory success for pharmaceutical companies, 5 key components of the cro’s regulatory process must be fully established and supported by the following key cro personnel and advanced technology. regulatory and medical writing writers should be experienced at producing all document types for major regulatory agencies by using the common technical document (ctd) format. technologies used by writers should drive efficiency and accuracy and speed the time to document completion. this should produce highquality documents that are properly managed across the document development life cycle. regulatory consulting and regulatory affairs there should be a robust drug development strategy to guide document development. this should include a clear submission strategy directed by effective leadership, a gap analysis to detect and provide solutions to inadequacies, and expedited pathways to advance urgent documents. this should be an integrated global strategy so that content from the primary submission can be reused for submission to multiple regulatory markets. regulatory operations the cro should be an expert at submitting regulatory documents by using advanced technology that is compliant with global health authorities. this expertise should include a simplified submission review, proactive management of timelines and deliverables, and electronic ctd delivery for every therapeutic area. regulatory technology to save time and resources, the cro should use advanced technology powered by artificial intelligence (ai) to map clinical data to templates and automate development of documents. diana henzel, pharmd / freelance medical writer, ace medical writing, norfolk, va “i can help you if you would just let me!”: the journey from vendor to trusted partner an interview with demetrius carter regulatory insights 174 amwa journal / v36 n4 / 2021 / amwa.org regulatory insights transparency and disclosure cros should meet and exceed compliance requirements by providing services such as data anonymization and redaction powered by ai, clinical trial postings and result disclosure, plain language summaries, and strategies to promote patient engagement. although the outlined approach may be ideal for large cros, smaller organizations may not have the financial resources to establish all 5 components. for example, significant technology investments may be too costly for small cros. in this situation, these organizations may choose to focus on achieving operational excellence and raising their profile through consistent and high-quality delivery of their medical writing and regulatory affairs services. amwa: what are some primary reasons for a failed cro– pharmaceutical company relationship? carter: some of the primary reasons for a failed cro–pharmaceutical company relationship include failing to deliver the document by the agreed upon timeline, delivering a document of poor quality that does not meet expectations or industry standards, missing a return on investment when the cost of services for the deliverable does not match the pharmaceutical company’s perceived value, and a failure to address ongoing performance concerns within the relationship. amwa: how can cros show their value to pharmaceutical companies? carter: by developing a unique value proposition (uvp). this will describe the benefits the cro can provide, and what makes these benefits valuable to the pharmaceutical company. the uvp should be focused and easy to articulate. for this to occur, the cro must understand the pharmaceutical company’s challenges and describe how the cro’s service will address those challenges. the cro must also present key differentiators that distinguish its services from those of other cros and describe the key benefits it brings to the table. finally, the cro must craft a message that demonstrates the value of their solution to the pharmaceutical company. amwa: how can writers improve their uvp? carter: to improve their uvp, writers should regularly review and reflect upon their performance by using a 360-degree review process that includes a self-evaluation. in addition, writers should choose 1 to 2 areas to improve upon annually, such as technical skills, knowledge, abilities, or competencies. a writer should compare the quality of the services provided with the fee the writer charges. this fee should be commensurate with the writer’s experience and the service provided. finally, writers should find opportunities to innovate, such as the use of technology to improve the quality and efficacy of their documents. in the book, good to great, jim collins describes the hedgehog concept.2 this concept is based upon understanding the intersection of 3 circles (figure 1). when using these circles, writers should consider 1. passion. to be the best, writers should only focus on activities they can be passionate about. 2. excellence. being good at something is not enough. writers must understand what they can excel at to truly be great. 3. drive. know what activities drive consistent and reliable capital and profitability. all 3 circles are required to transition from being good to being great. at the intersection of these circles is the target goal. amwa: how can writers create credibility when they are new to a team? carter: to create credibility, • be accountable, • demonstrate technical acumen, • give and earn respect, • talk less and act more, and • demonstrate commitment. amwa: how can writers manage a team without authority? carter: leading peers or more senior team members through document preparation requires writers to • understand the team goals and motivators, • set and document expectations at the project’s start, • be an empathetic listener, • hold team members accountable through consistent follow-up, • create positive visibility for team members, and • master their emotional intelligence. remember that managers control and direct but that leaders influence and inspire. figure 1. a depiction of the hedgehog concept. adapted from the jim collins website.3 passion driveexcellence amwa journal / v36 n4 / 2021 / amwa.org 175 regulatory insights amwa: do you have an example of a pharmaceutical company hiring a cro for its expertise but then not using this expertise? if so, how do you recommend mitigating the issue? carter: yes. in this example, a pharmaceutical company hires a cro for its therapeutic expertise and experience with the food and drug administration (fda) center for drug evaluation and research office of rare disease, pediatrics, urologic, and reproductive medicine. in their desperation to accelerate their new drug application (nda) submission due to competitive pressures and their desire to be first to market, the company asks the cro to write their summary of clinical safety and the integrated summary of safety with only 1 year of data, although fda guidance suggests at least 2 years of pivotal safety data. this places the nda at risk for rejection by the fda. to mitigate this issue, the cro should transparently share its concerns and prior experience and ensure that communication reaches key stakeholders. risks and mitigation strategies should be documented in meeting minutes. finally, the cro should stay motivated and demonstrate its technical expertise by delivering a quality document. amwa: do you have an example of a pharmaceutical company and cro not agreeing on a timeline? if so, how do you recommend mitigating the issue? carter: yes. in this example, the pharmaceutical company and cro agree in a contract that the clinical study report (csr) for a pivotal study will have 2 drafts and a final draft; however, the tables, listings, and figures (tlfs) will not be available until the final draft. this csr is on the critical path for the nda submission. here, the issue becomes the late delivery of the tlfs, which leads to compressed timelines for delivery of the final csr and a limited time for a full quality-control review. in this situation, the delays with the final draft are leading to a protracted review cycle with the introduction of new reviewers and new stakeholders. missing timelines or producing poor-quality deliverables can negatively impact long-term credibility and goodwill. to mitigate this issue, the writer, and project manager, if available, should assert themselves and push back. for example, they can advise the pharmaceutical company of the consequences of this shortened review cycle, and of changing reviewers and stakeholders. they should partner with the pharmaceutical company to negotiate a realistic timeline. to speed document development while the tlfs are not available, the writer should develop a shell csr by using draft or placeholder data and seek approval by using the agreed upon template. in addition, the writer should identify quality risks and mitigation upfront (eg, using draft data). finally, the writer should use online review technology (eg, pleasereview) to facilitate authoring followed by comment-resolution meetings. amwa:do you recommend that medical writers increase their project management (pm) skills? if so, what skills or concepts are important to project management? carter: yes. upskilling your pm skills is critical to increasing your effectiveness as a medical writer. pharmaceutical companies are increasingly expecting medical writers to take a leadership role within the submission team. pm is multifaceted and includes communication, teamwork, analysis, project planning, establishing a budget, establishing goals, understanding risks, problem solving, meeting deadlines, and reaching milestones. medical writers should be aware of 2 project management theories. in the first theory (figure 2),4 a project has 3 limitations: time, cost, and scope. time refers to the project timeline, cost refers to the budget established for the project, and scope refers to the project purpose and requested deliverables. a change in any one of these limitations will require an adjustment to the remaining limitations. for example, if the pharmaceutical company requires an expedited timeline, the cost of the project would increase as more writers are allocated to its completion. additionally, quality is a key factor with this theory because changes to any of the limitations may affect the quality of the deliverable. an updated version of this theory (figure 3)4 shows quality as a fourth limitation. customer satisfaction becomes the key factor in this second theory, as a project’s success is defined time scopecost quality customer satisfaction figure 2. project management theory 1. adapted from the skill point website.4 scope time cost quality figure 3. project management theory 2. adapted from the skill point website.4 176 amwa journal / v36 n4 / 2021 / amwa.org regulatory insights by meeting or exceeding a customer’s (pharmaceutical company’s) expectations. amwa: do you have an example of a pharmaceutical company losing confidence in a cro? if so, what advice do you have for the cro to regain the pharmaceutical company’s confidence? carter: yes. in this example, the pharmaceutical company and cro have been in a long-term consulting relationship; however, the last few projects have not gone well, which has resulted in the projects being pulled back in house. additionally, there have been changes in the internal leadership of the pharmaceutical company, which has led to a decline in outsourced projects to the cro. here, the issues include the negative feedback on recent projects and the relative anonymity of the cro in terms of the new leadership at the pharmaceutical company. confidence can be lost overnight, and regaining confidence takes a significant amount of time. to mitigate this issue, the cro should review the performance feedback and develop a corrective action plan, collaborate on the lessons learned, and take accountability. it can then offer some concessions to the pharmaceutical company, such as a lower rate or credit for future work. a cooling-off period may be necessary. in addition, successfully completing lower-complexity tasks may help reestablish credibility. amwa: do you have any proven techniques for transitioning a business relationship toward a partnership? carter: yes. to strengthen and transform the cro–pharmaceutical company relationship into a strategic partnership, a cro must build trust with the pharmaceutical company. trust is an outward expression of the value proposition a cro brings to the partnership. the letters of this acronym represent the qualities the cro must demonstrate: • technical competency—knowledge and skills to successfully complete the deliverable • reliability—trustworthiness and consistent performance • unity on purpose—understanding and alignment with the pharmaceutical company’s goals • service orientation—priority being given to the pharmaceutical company’s needs and excellent customer service • transparency—discussion of any issues and advice based on experience amwa:what are the key takeaways for transitioning from a relationship to partnership? carter: for a cro to transition from a transactional relationship to a strategic partnership with a pharmaceutical company, there are 3 takeaways: • manage projects effectively, • create and deliver on the uvp, and • establish value through trust. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contacts: diana henzel, dianahenzel@gmail.com; demetrius carter, demetrius.carter@certara.com references 1. carter d. “i can help you if you would just let me!”: best practices in overcoming a challenging sponsor. presented at: amwa carolinas 2021 spring conference; may 7, 2021; virtual. 2. hedgehog concept in the business sectors. jim collins website. published 2021. accessed june 28, 2021. https://www.jimcollins. com/article_topics/articles/hedgehog-concept-business-sectors. html#articletop 3. the hedgehog concept. jim collins website. published 2021. accessed june 28, 2021. https://www.jimcollins.com/concepts/the-hedgehogconcept.html 4. project management: what is the ‘triple constraint’ model? skill point website. published september 18, 2018. accessed june 28, 2021. https:// www.skillpoint.uk.com/triple-constraint-model/ learn online macroediting microediting save over 15% when purchasing as a package! mailto:dianahenzel@gmail.com mailto:demetrius.carter@certara.com https://www.jimcollins.com/article_topics/articles/hedgehog-concept-business-sectors.html#articletop https://www.jimcollins.com/concepts/the-hedgehog-concept.html https://www.jimcollins.com/concepts/the-hedgehog-concept.html https://www.skillpoint.uk.com/triple-constraint-model/ https://www.skillpoint.uk.com/triple-constraint-model/ https://www.amwa.org/page/online_learning v37 n2 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 41 as i write this article, it’s been a few weeks since the amwa board of directors (bod) met for an in-person board meeting in washington, dc. after two years of virtual meetings and numerous phone calls handling the organization’s strategic priorities and pertinent business, it felt good to be at an in-person bod meeting. this was not my first travel experience since the world opened back up for business. i’ve traveled twice before, and on each trip, i had the same mixed emotionstrepidation, excitement and a bit of normalcy. one thing i can say is that my recent in-person experiences has rejuvenated me, and i’m motivated more than ever to get back to traveling. as i attend several in-person celebratory events and make plans to travel with my family this summer, i am reminded of how truly blessed i am to not only survive through a pandemic, but also thrive in this new day. speaking of thriving, amwa also continues to thrive. we’ve seen an increase in membership when other organizations have seen a decline. recruiting and maintaining members continues to be one of our most important strategic priorities. amwa is here because of our members, and our commitment to serving our members’ needs stays foremost in my mind. i am deeply appreciative of the members that join the organization and jump right into learning and sharing their skills and talents with other amwa members. i believe amwa’s warm and welcoming atmosphere even during the virtual environment has attracted medical communicators from a variety of areas and locations around the world. as part of our discussion at the amwa spring board meeting, we reflected on the some of the threats and challenges to our profession, celebrated the wins of the organization, and made plans to initiate opportunities that will further benefit our members and continue to propel the organization forward. much of the amwa bod and staff’s work has centered around supporting and implementing our priorities and strategies to enhance our members experience, sharpen educational member tools and resources, and develop a digital footprint for the future of the organization. we’ve continued to work at an accelerated pace to keep up with the delivery of educational materials and resources most important to our members. we are excited about the continued growth of member resources and the work to come from the education committee, and i look forward to seeing what’s next for the diversity & inclusion (d&i) assessment task force. like many of you, i try to stay focused, keep up with technology, and develop new skills to stay relevant in my field. being open to learning new skills and transitioning your skillset into more opportunities is one of the reasons why amwa has been so important to my growth. being able to transition to new technology and platforms also has been an important part of amwa’s growth, and i am thrilled to see it. as you are aware, the amwa journal transitioned to a digital format in open journal systems (ojs) and launched the first digital issue in march. not only is the amwa journal team working to align publication content with the organization’s content strategy, they have initiated themebased issues and have incorporated guest editors for each issue. i hope you’ve had an opportunity to see the journal in its digital format and read some of the rich content. throughout the first half of my term as president i’ve witnessed some great educational programming delivered at the chapter level. i’m excited to see innovative and interesting content being offered through virtual programming and networking events. many chapters hosted spring virtual conferences across the amwa platform, and i am happy to know that some members of amwa’s executive committee (ec) were able to attend or participate in some of the conferences. from the president a new day amwa news katrina r. burton, bs / 2021–2022 amwa president http://www.amwajournal.org amwajournal.org 42a new day speaking of conferences, i look forward to attending and presenting at amwa’s southeast regional conference in fort myers, florida this summer. the collaborative conference between the southeast, florida, and carolinas chapters’ will be the first in-person amwa conference in more than 2 years, and the conference will offer a variety of educational sessions and workshops. i will join other amwa faculty in presenting content from my skillset applicable to medical communicators in different phases of their careers. as we continue to transition and get back to in-person events at both the chapter and national level, i am most excited about the upcoming 2022 medical writing & communication conference taking place in denver, colorado, nov. 2-5. this year’s annual conference theme— elevating health and well-being through medical communication—perfectly aligns with what we as medical communicators strive to do every day. with the 2022 medical writing & communication conference taking place in person this year, some things may change with logistics and protocols for safety reasons; however, the rest of the annual conference experience will remain the same. in addition to networking with your peers, and enjoying the local fine dining, conference attendees can expect to feel amwa’s warm and welcoming environment; experience a variety of workshops and sessions; and celebrate this year’s john p. mcgovern, walter c. alvarez, and harold swanberg award recipients, and more. i hope we will see you in denver, healthy, thriving and ready to have a great experience because you deserve it! www.amwa.org/mwc three little letters. one big deal. apply now apply by october 17 for december 2022 exam. review our applicant handbook, candidate guide, and study tips to help you prepare. http://www.amwajournal.org http://www.amwa.org/mwc v37 n4 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 29 abstract i am a firm believer that things happen for a reason, but also that good comes from talking about how things came to be the way they are. the first part of this article describes my personal journey navigating the complexities of having a disability concurrently with those of being a medical writer and from that standpoint can be considered subjective compared with the data-driven information we are used to seeing in our daily work. it is not meant to be a history on disability law or a comprehensive treatise on why people with disabilities are underemployed—other authors have covered those topics in great detail in other milieus, to incremental avail—but, rather, to raise awareness of potential challenges within the medical writing context and how navigating stakeholders’ assumptions about health circumstances can be as arduous as managing the health condition itself. the second part of this article provides practical suggestions on things the medical writing community can do to make sure their own can keep being strong contributors no matter what their circumstances are in life. it is the author’s hope that this article will represent the start of a dialogue within our community and that by sharing one story others feel comfortable sharing their own. growing up, both of my parents were disabled. so, from a young age, i always had many responsibilities and frequently found myself teaming up with my brother to get through chores—more chores than my friends ever had. the silver lining is that this circumstance gave me the work ethic and sense of teamwork i have today, but i was also witness to the struggles my parents faced in the health care system, including a lack of access to therapies and stigma. i often think of how i am just about the same age now as my mother had been when she was forced to leave the workplace because of her health condition. about 7 years ago, i started to encounter my own health issues. at the time, i was an undisputed strong scientific contributor, and my managers stated as much in reviews. i had progressed on a steady path from writing to upper management. eventually, however, i could not follow the pattern of a normal workday and simultaneously address my health concerns. many of the challenges i faced involved someone in a decision-making capacity making assumptions about my intentions, my needs, or my work—assumptions that were fundamentally false. here is an example: i was 5 minutes late to a meeting because i had to run to the bathroom to take a medication i need at a certain time of day. a company leader assumed i was not being respectful of her time and confronted me upon my arrival. here is another example: i hurt my back overexerting myself during a regulatory submission (too many consecutive hours at my desk), and i had to go to physical therapy. because i could not make late-day submission meetings, i was told i was failing at my job. it seemed that overnight, despite having declared my disability and asked for accommodations from day 1, i would not be permitted to maintain a seat at the table, so to speak—one that i had worked so hard to earn. so, i had to create a new table. now, i put into my business all the time and energy i used to dedicate to someone else’s vision. i often think back to what it would have been like for my mother had a work-from-home option been more commonplace, and had she not been forced to leave the workforce at such a young age. i was lucky that i found another avenue to be able to continue contributing, although i would be remiss if i implied this was an easy path. as a hiring manager, i also hear all the time other examples of the type of issues i ran into, including women who either were told they would not want to come back to work after they had their babies or were told they outright had no job to come back to once they went out on maternity leave. this is the ladder of assumptions rearing its ugly head; in these cases, the person on the receiving end of data has translated an observation through a series of filters (the reflections on working as a medical writer with a disability and how medical writers can be disability allies jeanette m. towles, ma, rac-drugs / synterex, inc, dedham, ma topical feature http://www.amwajournal.org amwajournal.org 30how medical writers can be disability allies rungs on the ladder) into a conclusion (figure 1). the conclusion might seem right because it is based on what the observer comes to believe is true, but that truth has no correlation with the reality of the intentions or actual circumstances of the person being observed. the stress of coping with a health concern compounded with that of managing the aspersion of others’ inferences amount to a recipe for failure for anyone who cares deeply about what they do for a living. add to that the stress of deadlines, strict regulations, and other quirks inherent in our industry—perhaps not even knowing who to trust to talk to about any conflicts that have come up or accommodations needed, or embarrassment over how these things have been actioned to date—and one could quickly end up with a work environment that contributes further to health decline and precludes continued work. i cannot go back in time and change others’ reactions or my health, or convince my younger self to have courage because it does get better, but i can advocate so that no one else in our community unwittingly finds himself or herself in the same situation without help. toward those goals, here are some tips on how not to fall victim to the ladder of assumptions and to support those with disabilities working in our medical writing community. 1. avoid making assumptions about capabilities. when employers think about hiring those with disabilities, the desire may be there in theory, but the procedures and infrastructure to do so may seem prohibitively daunting. there is often confusion over even the etiquette of how to interact with prospective employees with disabilities and fear over saying too much or too little.2 this hesitation is reflected by the rate of unemployment by those with disabilities historically being nearly twice that of those who do not have disabilities.3 to overcome this barrier, avoid making assumptions that a resource or vendor is not qualified enough or will need too much help to be effective; individuals with disabilities or disability-owned business enterprises bring expertise and very often have a commitment to hiring others who have also experienced or been a victim of the ladder of assumptions. keep in mind: these are individuals who, due to something intrinsic that they had no control over, are used to overcoming as barriers things that are quotidian to everyone else. a recent disability-related article circulating on social media about the return to the office after covid-19-related closures details barriers such as “inaccessible commutes, painful chairs, binding clothing,” and “social cues in break rooms,” but also, in the experience of one worker with cerebral palsy, “even the inherent focus needed to move through a building,” as she navigated the fear of falling while moving between multiple meeting rooms daily.4 according to a leading organization that helps promote corporate inclusion efforts, disability:in, workers with disabilities are “regularly forced to adapt to an inaccessible world, and these experiences have sharpened their problem-solving skills and their capacity for innovation.”5 these skills would make for an ideal medical writer in any circumstance. to address the question about what you can or should say (or cannot and should not say) to an employee who has a disability, there are some guidelines from the equal opportunity and employment commission, which are slightly different prior to hire and after hire (figure 2 on next page).6 prior to a job offer, you cannot ask questions about an applicant's disability or questions that are likely to reveal whether an applicant has a disability, even if the disability is visually apparent. employers can ask an applicant to voluntarily report a disability for affirmative action purposes.6 following hire but before start of work, an employer may ask disability-related questions and conduct medical examinations as long as it does so for all employees in the same job category. after employment begins, an employer may make disability-related inquiries and require medical examinations only if they are “job-related and consistent with business necessity.” figure 1. the ladder of assumptions (also known as the ladder of inference). adapted from: senge 1994.1 data actions beliefs conclusions assumptions meaning data selection http://www.amwajournal.org amwajournal.org 31how medical writers can be disability allies beyond the regulations, however, the key thing is to remember that what an employee who has a disability generally wants in the workplace is not to feel like his or her role or talents are diminished, even if he or she gets to the same goals a little differently (figure 2). avoid terminology like “handicapped” that causes the individual behind the disability to be minimized and words that pity the person with the disability.2 essentially, operate just as you would with anyone else. lastly, to quote my mentor and disability advocate joyce bender (2021), “sign the contract!” to truly have an inclusive workplace is to not only interview those with disabilities—either those who self-identify or by intentionally seeking out any number of available databases of prescreened individuals or vendors with disabilities who are seeking work—but also to follow through to onboarding that disabled employee or vendor. that person cannot maintain their economic freedom7 or contribute just by a company providing them lip service. the people who work on medicines in the life sciences, and thus the people who manage documents to help those medicines get to the clinic and market, should be reflective of the people in the community who will receive those medicines, which includes the over 1 billion people living with disabilities worldwide.3,8 even if no formal employee resource groups have been formed, make sure that any support resources are created and posted in an accessible way. according to a web accessibility company’s assessment, up to 98% of us-based websites are not fully accessible, and other research by the pew research center showed that people with disabilities are approximately 3 times as likely to never go online and are around 20% less likely to subscribe to home broadband and own a computer, smartphone, or tablet. so, change can happen from the level of content creation.10 it is equally important to leverage your influence to promote a culture that does not cause your employees to defend themselves or their needs repeatedly. as an example, i once had to fill out a form justifying equipment accommodations that had to be approved by 3 different figure 2. communication guidelines for interacting with an employee or prospective employee who has a disability.2,6 2. have a support system in place. it is fundamental to point out: not every disability is the same. do your homework. these are potential corporate resources for integrating employees with disabilities into your team: 1) formal training programs for those without disabilities to learn about the tools and accommodations available for better integration across teams; 2) formal tailored onboarding programs, including disability-specific information such as reasonable accommodation procedures and orientation materials that are in accessible formats; 3) mentoring and career development programs; and 4) employee resource groups.3,9 http://www.amwajournal.org amwajournal.org 32how medical writers can be disability allies managers, which seemed like an unnecessary process causing me to have to disclose my needs repeatedly across the company, which may make some people uncomfortable. once an employee states their requested accommodations to human resources, they should not have to repeat them or remind anyone; it is the company’s job (and in the company’s best interest) to know what that person needs to do their job successfully. also, if someone in the disabled community is brave enough to come to you with suggestions on how to make a policy more inclusive or a resource more accessible, any instinct toward defensiveness should be resisted—or, worse, gaslighting and telling the person it does not impact them; they are not pointing out an issue to you because they think whoever put the policy or resource in place is a bad person but, rather, because their unique viewpoint may not have been known when it was put in place. 3. after you listen, be vocal about your support. the americans with disabilities act of 1990 (ada) makes it unlawful to discriminate in employment against a qualified individual with a disability.11 under the ada, employers are required to offer reasonable accommodation, which is defined as “any change or adjustment to a job or work environment that permits a qualified applicant or employee with a disability to participate in the job application process, to perform the essential functions of a job, or to enjoy benefits and privileges of employment equal to those enjoyed by employees without disabilities.” let your colleagues know, both within and outside of medical writing, that including those with disabilities in your resourcing pool, as well as offering economically feasible accommodations per the ada, is not just a requirement to be dealt with—it is a winning strategy. in fact, the majority of requested accommodations cost nothing to implement, with the rest costing only $500 per employee on average.3 common accommodations in the medical writing field may include more obvious ones like equipment requests (adjustable height desks, headsets), software (speech recognition, closed captioning), or flexible schedule, but there may be other less obvious ones such as need for accompanying service animals, a quiet or lighted workspace, a space with certain temperature parameters, or need for a color-coded filing system.12 given that disability inclusion is also gaining ground as an important topic for corporate responsibility and investors, with more ceos every day signing onto pledges like “investors are ‘in’” and “ceos are ‘in’” and using tools like the disability equality index, a benchmarking tool that helps companies build a roadmap of measurable actions that they can take to achieve disability inclusion and equality it is likely that most boards of directors would be supportive of and tout any successes you have had making your medical writing team more inclusive.5,13,14 this index is scored on a scale of 0 to 100 points, with 80 and above achieving a title of “best places to work for disability inclusion,” and measures based on answers and supporting documentation for the current year (or, for some questions, a recall of 1 year) the weighted domains of culture and leadership, enterprise-wide access, employment practices, accommodations, and supplier diversity, as well as the nonweighted domain of non-us operations. in fact, the board of directors will be so supportive because data have shown that those who championed or improved upon their corporate disability inclusion practices were more likely to have shareholder returns outperforming those who did not champion or improve their practices.3 4. celebrate disability. during the covid-19 pandemic, the author heard from many medical writing managers that they were trying to cut their employees slack for extenuating circumstances (including caring for children or sick family members), in particular when it came to performance evaluations, and to ensure the protection of their time off and work-life balance (2021). this was a breath of fresh air and should absolutely continue. as we envision what a return to the office or living with the pandemic looks like, it will be critical to bear in mind that there will be a large segment of the population who will still face the same day-to-day struggles of trying to fit in with a typical pattern of the workplace or workday, and that their intrinsic features create hurdles for them every day in the workplace, in addition to any extrinsic hurdles (like covid-19). now that we have proven that people can innovate (including producing life-saving vaccines for a novel virus) without being in the office face-to-face, and that it is not prohibitive to have a budget for technologies to enable accessible work, will we maintain that position so that those with mobility issues, for example, can innovate with us? i, for one, am hopeful that we can do this within medical writing and serve as a paragon of how to do it right. it should also be pointed out that medical writers with disabilities make for fierce leaders, as they already are used to advocating and negotiating to get what is needed. as disability:in points out, “the very experiences that have resulted in exclusion from all levels of corporate america are what make them such important assets to corporations…they are a large untapped labor force market due to inaccurate assumptions about their abilities; they http://www.amwajournal.org amwajournal.org 33how medical writers can be disability allies represent a significant consumer population; and they bring different perspectives.”13 it has further been acknowledged by disability:in that “companies that are disability-inclusive are thus better positioned to execute responsible governance, effective risk management, and optimal decision-making, as well as enhanced customer alignment, employee engagement, and transparency, as compared with those without.”13 thus, it is important not only to include people with disabilities on your medical writing team but also to give them the support and resources they need to get where they want to go in their careers, including positions of leadership. your department will shine within the organization as a result of these efforts, and good leaders will create other leaders. conclusions as hard as it is to tell a story that may evoke feelings of exclusion or pain, the more we tell our stories in the medical writing community about how it is to work with a disability in the health care field, or about any other times we may have been affected by the ladder of assumptions, the better chance we have of colleagues understanding our needs and how to help us in the workplace. by following the tips in this article, and by engaging with your employees to find out what else they need to feel supported for their specific situation, you can start your journey to making your medical writing team successful in disability inclusion and not accidentally rule out your best employees with preconceived notions. coming together in our community around this topic through more regular and open dialogue hopefully will lead us to a universal position: we are not going to allow our colleagues with disabilities to lose the opportunity to contribute, and we are not going to lose strong leaders from the workplace due to lack of accessibility. not on our watch. acknowledgment editorial and artwork support was provided by carrie patrick, synterex, inc, dedham, ma. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. the opinions expressed in this article are the authors’ own and are not necessarily shared by their employers or amwa. author contact: jtowles@synterex.com references 1. senge pm, kleiner a, roberts c, ross rb, smith bj. the fifth discipline fieldbook: strategies and tools for building a learning organization. currency; 1994. 2. bender consulting. disability 101: understanding the terms of engagement. bender consulting services website. published august 18, 2021. accessed may 23, 2022. https://benderconsult. com/disability-101-understanding-the-terms-of-engagement/ resources general guidance on being a disability ally: ladau e. demystifying disability: what to know, what to say, and how to be an ally. ten speed press; 2021. equal employment opportunity commission guidance: equal employment opportunity commission. enforcement guidance: preemployment disability-related questions and medical examinations. equal employment opportunity commission; 1995. accessed may 23, 2022. https://www.eeoc. gov/laws/guidance/enforcement-guidance-preemploymentdisability-related-questions-and-medical#self-identify recruiting, hiring, retaining, and promoting people with disabilities: iyer a, masling s, equal employment opportunity commission. recruiting, hiring, retaining, and promoting people with disabilities. equal employment opportunity commission; 2015. accessed may 23, 2022. https://www. shrm.org/resourcesandtools/hr-topics/talent-acquisition/ documents/employing_people_with_disabilities_toolkit_ february_3_2015_v4.pdf inclusive language in medical writing: walker gj. 5 tips for equity and inclusion in medical writing and editing. amwa website. published april 26, 2021. accessed may 23, 2022. https://blog.amwa.org/equity-inclusion-tips document accessibility: bender consulting. document accessibility: can you read this. youtube website. published february 21, 2020. accessed may 23, 2022. https://www. youtube.com/watch?v=b5bm-sg7hs8 digital accessibility: bender consulting. website accessibility: the ramps and rails of the digital world. youtube website. published february 12, 2020. accessed may 23, 2022. https://youtu.be/b5bm-sg7hs8 meeting accessibility: disability:in. six tips to keep in mind when creating accessible virtual meetings. disability:in website. accessed may 23, 2022. https://disabilityin.org/ resource/six-tips-to-keep-in-mind-when-creating-accessiblevirtual-meetings/ accommodations: job accommodation network. 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https://blog.amwa.org/equity-inclusion-tips#:~:text=in%20her%20amwa%20webinar%2c%20writing,differences%2c%20and%20promotes%20equal%20opportunities https://youtu.be/ujecsbupz50 https://youtu.be/ujecsbupz50 https://youtube/b5bm-sg7hs8 https://disabilityin.org/resource/six-tips-to-keep-in-mind-when-creating-accessible-virtual-meetings/ https://disabilityin.org/resource/six-tips-to-keep-in-mind-when-creating-accessible-virtual-meetings/ https://disabilityin.org/resource/six-tips-to-keep-in-mind-when-creating-accessible-virtual-meetings/ https://askjan.org/publications/employers/employers-guide.cfm https://askjan.org/publications/employers/employers-guide.cfm https://www.disabilityequalityindex.org/deisurvey/annual_dei_questions.pdf https://www.disabilityequalityindex.org/deisurvey/annual_dei_questions.pdf amwajournal.org 34how medical writers can be disability allies 3. american association of people with disabilities (aapd) and accenture. the disability inclusion advantage. published 2018. accessed may 23, 2022. https://www.accenture.com/_acnmedia/ pdf-89/accenture-disability-inclusion-research-report.pdf 4. dawson k. workplace evolution: 3 disabled workers share how ‘returning to normal’ makes work inaccessible. fast company website. published may 11, 2022 accessed may 23, 2022. https:// www.fastcompany.com/90750720/3-disabled-workers-share-howreturning-to-normal-makes-work-inaccessible?partner=rss&utm_ campaign=rss+fastcompany&utm_content=rss&utm_medium= feed&utm_source=rss 5. disability:in. ceos are in: ceos are ‘in’ for the disability equality index. disability:in website. accessed may 5, 2022. https://disabilityin.org/ceos-are-in/ 6. us equal employment opportunity commission. what can’t i ask when hiring? us equal employment opportunity commission website. accessed may 23, 2022. https://www.eeoc.gov/ employers/small-business/4-what-cant-i-ask-when-hiring 7. women in bio. wib-national at bio digital 2021: disability inclusion – being an ally in the workplace. youtube website. published june 18, 2021. accessed may 5, 2022. https://www. youtube.com/watch?v=vvnqd3on2u0 8. disability:in. business case for disability inclusion. accessed may 5, 2022. https://disabilityin.org/resource/business-case/ 9. iyer a, masling s. recruiting, hiring, retaining, and promoting people with disabilities. equal opportunity employment commission; 2015. accessed may 23, 2022. https://www. shrm.org/resourcesandtools/hr-topics/talent-acquisition/ documents/employing_people_with_disabilities_toolkit_ february_3_2015_v4.pdf 10. al-heeti a. the original voice of siri is now advocating for a more accessible web. cnet website. published october 1, 2021. accessed may 23, 2022. https://www.cnet.com/tech/mobile/theoriginal-voice-of-siri-is-now-advocating-for-a-more-accessibleweb/ 11. equal opportunity employment commission. the ada: your responsibilities as an employer. equal opportunity employment commission website. accessed may 23, 2022. https://www.eeoc. gov/laws/guidance/ada-your-responsibilities-employer 12. district of columbia office of disability rights. types of reasonable accommodation. dc.gov website. accessed may 23, 2022. https://odr.dc.gov/book/manual-accommodatingemployees-disabilities/types-reasonable-accommodation 13. disability:in. investors are in: investors encourage their portfolio companies to capitalize on the opportunities of disability inclusion. disability:in website. accessed may 5, 2022. https:// disabilityin.org/investors-are-in/ 14. disability:in. about the dei. disability:in website. accessed may 5, 2022. https://disabilityin.org/what-we-do/disability-equalityindex/ unlock the secrets to freelance success with this 3-part on-demand video series. gain relevant and practical advice from industry pros. run your business like a pro. • essential ingredients of a successful freelance business • bad behaviors that can sabotage your business • getting the clients you deserve unlock now in amwa online learning: www.amwa.org/freelance_success http://www.amwajournal.org https://www.accenture.com/_acnmedia/pdf-89/accenture-disability-inclusion-research-report.pdf https://www.accenture.com/_acnmedia/pdf-89/accenture-disability-inclusion-research-report.pdf https://www.fastcompany.com/90750720/3-disabled-workers-share-how-returning-to-normal-makes-work-inaccessible?partner=rss&utm_campaign=rss+fastcompany&utm_content=rss&utm_medium=feed&utm_source=rss https://www.fastcompany.com/90750720/3-disabled-workers-share-how-returning-to-normal-makes-work-inaccessible?partner=rss&utm_campaign=rss+fastcompany&utm_content=rss&utm_medium=feed&utm_source=rss https://www.fastcompany.com/90750720/3-disabled-workers-share-how-returning-to-normal-makes-work-inaccessible?partner=rss&utm_campaign=rss+fastcompany&utm_content=rss&utm_medium=feed&utm_source=rss https://www.fastcompany.com/90750720/3-disabled-workers-share-how-returning-to-normal-makes-work-inaccessible?partner=rss&utm_campaign=rss+fastcompany&utm_content=rss&utm_medium=feed&utm_source=rss https://www.fastcompany.com/90750720/3-disabled-workers-share-how-returning-to-normal-makes-work-inaccessible?partner=rss&utm_campaign=rss+fastcompany&utm_content=rss&utm_medium=feed&utm_source=rss https://disabilityin.org/ceos-are-in/ https://www.eeoc.gov/employers/small-business/4-what-cant-i-ask-when-hiring#:~:text=you%20can%20ask%20the%20applicant,medications%20are%20you%20currently%20taking%3f https://www.eeoc.gov/employers/small-business/4-what-cant-i-ask-when-hiring#:~:text=you%20can%20ask%20the%20applicant,medications%20are%20you%20currently%20taking%3f https://www.eeoc.gov/employers/small-business/4-what-cant-i-ask-when-hiring#:~:text=you%20can%20ask%20the%20applicant,medications%20are%20you%20currently%20taking%3f https://www.youtube.com/watch?v=vvnqd3on2u0 https://www.youtube.com/watch?v=vvnqd3on2u0 https://disabilityin.org/resource/business-case/ https://www.shrm.org/resourcesandtools/hr-topics/talent-acquisition/documents/employing_people_with_disabilities_toolkit_february_3_2015_v4.pdf https://www.shrm.org/resourcesandtools/hr-topics/talent-acquisition/documents/employing_people_with_disabilities_toolkit_february_3_2015_v4.pdf https://www.shrm.org/resourcesandtools/hr-topics/talent-acquisition/documents/employing_people_with_disabilities_toolkit_february_3_2015_v4.pdf https://www.shrm.org/resourcesandtools/hr-topics/talent-acquisition/documents/employing_people_with_disabilities_toolkit_february_3_2015_v4.pdf https://www.cnet.com/tech/mobile/the-original-voice-of-siri-is-now-advocating-for-a-more-accessible-web/ https://www.cnet.com/tech/mobile/the-original-voice-of-siri-is-now-advocating-for-a-more-accessible-web/ https://www.cnet.com/tech/mobile/the-original-voice-of-siri-is-now-advocating-for-a-more-accessible-web/ https://www.eeoc.gov/laws/guidance/ada-your-responsibilities-employer https://www.eeoc.gov/laws/guidance/ada-your-responsibilities-employer https://odr.dc.gov/book/manual-accommodating-employees-disabilities/types-reasonable-accommodation https://odr.dc.gov/book/manual-accommodating-employees-disabilities/types-reasonable-accommodation https://odr.dc.gov/book/manual-accommodating-employees-disabilities/types-reasonable-accommodation https://disabilityin.org/investors-are-in/ https://disabilityin.org/investors-are-in/ https://disabilityin.org/what-we-do/disability-equality-index/ https://disabilityin.org/what-we-do/disability-equality-index/ amwajournal.org 17session reports conclusion this session covered what infographics are, why they are used, when they are used, and when they shouldn’t be used. in general, they may help you identify your audience and goals, communicate data and other health information, reinforce your message visually, educate across barriers, create awareness, and encourage action. sunali wadehra is a freelance medical writer at wadehra medical writing, llc, in st. louis, mo. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: sunali@wadehramedicalwriting.com reference 1. cox lk. why are infographics so darn effective? [infographic]. hubspot website. updated july 28, 2017. accessed october 2021. https://blog.hubspot.com/marketing/effectiveness-infographics# sm.0001lqkcekbcccr810862dx9nrvhr * * * the importance of data presentation speaker barry drees, phd, senior partner, trilogy writing & consulting gmbh, frankfurt, germany by sampoorna rappaz, phd the effectiveness of medical communication hinges on both the text and the accompanying data presentation being fit-for-purpose. dr barry drees, in his presentation at amwa’s 2021 medical writing & communication conference, explained how we can fulfill the ultimate purpose of data presentation, which is to tell a story clearly and simply. using examples from the domain of regulatory writing, scientific communication, and medical and world history, he illustrated how good data presentation can help focus the message, correct misperceptions, and even save lives! when done well, each element of data presentation within a document communicates 1 main message, which is determined by the question that the data are answering. identifying this question and the message will help us decide how to best represent the data (figure). distinct data presentation types exist, each suited to a unique purpose. once we have made a choice, we can use logical design principles to highlight and clarify the message. design considerations for tables dr drees has the following advice for creating tables: resource list for inspiration • designspiration.com • good.is/infographics • dailyinfographic.com • abdz.do for design assistance • infogr.am • piktochart.com • easel.ly • visual.ly figure. how to determine the right data presentation type. the purpose and message of the data presentation and the type of data variable will direct our choice. http://www.amwajournal.org https://blog.hubspot.com/marketing/effectiveness-infographics#sm.0001lqkcekbcccr810862dx9nrvhr https://blog.hubspot.com/marketing/effectiveness-infographics#sm.0001lqkcekbcccr810862dx9nrvhr https://blog.hubspot.com/marketing/effectiveness-infographics#sm.0001lqkcekbcccr810862dx9nrvhr http://designspiration.com http://good.is/infographics http://dailyinfographic.com https://abduzeedo.com/ https://infogram.com/ https://piktochart.com/ https://easel.ly/ https://visual.ly/product/infographic-design amwajournal.org 18session reports • choose a design that makes comparisons easy and keep the key comparators next to each other. • ensure column headings accurately describe the data within their respective fields. • ensure that the “total” presented at the bottom of the column is always the sum. • be consistent with text and number alignment. for easier reading, use the top alignment for column headings. • keep the table clutter-free. if adjacent data are identical, use a footnote. use exponents when appropriate. • use an unambiguous footnote-labelling system. if the style guide allows it, use the alphabet, as this provides enough options and allows for logical organization. avoid using a number-based system when data are numerical. • double-check for “footnote ghosts.” all footnote symbols and abbreviations listed below the table must appear within the table field. • avoid empty cells. blank spaces within a table field can confuse the reader (and the layout editor!). design considerations for graphical representations dr drees has the following advice for creating graphical representations: • ensure axis labels are clear, accurate, and legible. • ensure final figure is large enough for the details to be visible. • keep graphs as simple as possible so that differences are easily discernible. “fancy” or “trendy” design principles (eg, too much “nondata ink”) can be misleading. • for line graphs, – restrict use to continuous variables. – ensure individual lines can be easily followed. – use a trend line to improve clarity. • for bar or column graphs, – avoid stacked bar graphs, as they make comparing the nonflush variables (ie, those not aligned along the axis) difficult. instead, use a grouped column graph and, if required, add a column for total. – avoid using different shades of gray or striping to distinguish variables or categories, as these are affected by print quality. – avoid adding numbers to the top of bars. if numbers are essential for clarity, then use a table. • for pie charts, – restrict use to instances in which percentage points add up to 100%. – restrict use to instances in which the main message can be illustrated with 1 or 2 clear segment(s). – make content user-friendly by starting segmentation at the 12 o’clock position, using appropriate colors or shades, and identifying the segments with a clear key or with labels on or next to segments. • avoid including many pie charts, as they are difficult to compare. • avoid three-dimensional graphs. these graphs create an optical illusion and can hide data points. focus on the essential data presentation is a tool that should be used only when required, and each representation must be integral to the document. good data presentation will make the accompanying text obvious and easy to write. we must not use data presentation for “data storage” or as means to show off the amount of data collected. we need to balance the quantity of information against the clarity of the message. our focus should be on the story being told and on the impact of the data presentation. sampoorna rappaz is a freelance medical writer and editor based in switzerland. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: sampoorna.satheesha@gmail.com http://www.amwajournal.org a m w a news elise eller / 2020-2021 director-at-large and chair and board liaison, member awards committee the harold swanberg distinguished service award, named in honor of one of the founders of amwa, is presented to an active amwa member who has made distinguished contributions to medical communication or rendered unusual and distinguished services to the medical profession. this year’s swanberg recipient is lori l. alexander, mtpw, els, mwc. lori has made distinguished contributions to the medical communication profession for more than 30 years, most recently in the area of education of medical communicators. lori is an advocate for professional development and lifelong learning. lori’s work history in medical communication has spanned a variety of settings, providing experience in different types of medical communication. her work has involved editing, writing, project management, and development of educational resources for health care professionals and the lay public. lori’s contributions to the field of medical communication span service both within and outside of amwa. highlights of lori’s service to amwa include serving as editor of the amwa journal, chairing the annual conference programming committee (twice) and the education committee, serving on several working groups and task forces, serving as amwa president and on the amwa board of directors, and, most recently, serving as amwa director of education. in these roles, lori has explored and determined members’ educational needs and preferences, helped amwa create educational activities and resources to fit those needs, developed processes that ensure the consistent high quality of amwa’s educational products, and thought and acted strategically to help amwa achieve its goals. it is because of lori that amwa has a content strategy for developing educational offerings online and at the annual medical writing & communication conference. it is also because of lori that amwa is now offering new workshops and the new knowledge builders in the amwa catalog. lori also helped establish and develop a medical writing and editing certificate program, which focuses on regulatory writing, journal publications, continuing education, and grant writing, for the university of california san diego extension. until her retirement, lori continued to serve as the consulting director and lead faculty to provide strategic direction for the program. lori’s long-standing service demonstrates her passion for promoting excellence in medical communication. amwa is proud to recognize lori as the recipient of the 2021 harold swanberg distinguished service award. sadly for the amwa community and all who knew her, lori passed away on june 4, 2021. we will miss lori's energy and sense of humor, and our thoughts go out to lori's wife, deb whippen, and to her family and friends. harold swanberg distinguished service award amwa journal / v36 n2 / 2021 / amwa.org 95 a m w a news the john p. mcgovern award is named in honor of john p. mcgovern and is presented to a member or nonmember of the american medical writers association (amwa) to recognize a preeminent contribution to any of the various modes of medical communication. the mcgovern award is presented during the annual amwa medical writing & communication conference. i am pleased to announce this year’s john p. mcgovern award recipient: stacy l. christiansen, ma. ms christiansen’s contribution to the field of medical communication is crystal clear to so many members of amwa, as she is the managing editor of the journal of the american medical association (jama) and chair of the american medical association (ama) manual of style committee. in the words of her colleagues who nominated her, “ms christiansen’s numerous, important contributions to multiple modes of medical communication embody all that the john p. mcgovern award represents— leadership, excellence in medical writing and editing, and benevolent mentoring of editors, manuscript editors, authors, and writers.” ms christiansen received a bachelor of arts and master of arts in english language and literature from northern illinois university. she has worked for jama since 1998 and has worked as the managing editor since 2013. many amwa members also know her through her active membership and engagement in the council of science editors (cse); ms christiansen serves as a faculty member for the cse short course for manuscript editors. she has taught in the university of chicago medical writing and editing program. as managing editor of jama, ms christiansen regularly communicates with jama authors and representatives of international professional societies and agencies from around the world to provide advice about communicating research results and medical information and often resolves complicated editorial and policy issues with authors. her colleagues cite her recent challenge of navigating more than 10,000 coronavirus disease 2019 (covid-19)–related submissions to the journal, for which she subsequently led efficient and excellent editing and publication of more than 300 covid-19–related articles to inform clinicians, policy makers, and the public. the ama manual of style was first published in 1962.1 as chair of the ama manual of style committee, ms christiansen was responsible for leading the major revision and publication of the 11th edition, published in 2020. she continues to guide the committee to address ongoing issues in medical writing and editing, as well as changes in usage that parallel the constantly changing ways we communicate. for example, during 2020, she led efforts to modify guidance for the reporting of race and ethnicity in medical publications and developed usage nomenclature for terms related to the severe acute respiratory syndrome coronavirus 2 (sarscov-2) and covid-19. the mcgovern award recipient is not required to be a member of amwa. however, not only is ms christiansen an active member, but she has also presented at many conferences, written articles for amwa journal, and regularly connects with amwa members on twitter—as the resident tweeter for the ama manual of style. on behalf of our entire organization, it is a joy to congratulate ms christiansen on this prestigious award! author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: conference@amwa.org reference 1. american medical association. ama manual of style: a guide for authors and editors. brief history of the ama manual of style. accessed april 25, 2021. https://www.amamanualofstyle.com/page/amahistory gail v. flores, phd / 2020-2021 amwa president 2021 john p. mcgovern award recipient: stacy l. christiansen, ma 96 amwa journal / v36 n2 / 2021 / amwa.org mailto:conference@amwa.org https://www.amamanualofstyle.com/page/amahistory a m w a news the walter c. alvarez award, named in honor of an early medical communicator, is presented to an individual who is the epitome of excellence in communicating health care developments and concepts to the public. this year’s alvarez award winner is ms harriet washington. harriet a. washington is a science writer, editor, and ethicist who is the author of carte blanche: the erosion of informed consent in medical research (2021, columbia global reports) and a terrible thing to waste: environmental racism and its assault on the american mind. she has been writing fellow in bioethics at harvard medical school, the 2015-2016 miriam shearing fellow at the university of nevada’s black mountain institute, a research fellow in medical ethics at harvard medical school, visiting fellow at the harvard th chan school of public health, a visiting scholar at depaul university college of law, and a senior research scholar at the national center for bioethics at tuskegee university. she has also held fellowships at stanford university and teaches bioethics at columbia university, where she delivered the 2020 commencement speech to columbia’s school of public health graduates, and won the 2020 mailman school of public health’s public health leadership award, as well as the 2020-2021 kenneth and mamie clark distinguished lecture award. in 2016, she was elected a fellow of the new york academy of medicine. her work helped provide the basis for the ama apology to the nation’s black physicians in 2008 and led to the banishment of the james marion sims statue from central park in 2018. ms washington has written widely for popular and science publications and has been published in referenced books and journals such as nature, jama, the american journal of public health, the new england journal of medicine, the harvard public health review, isis, and the journal of law, medicine, and ethics. she has been editor of the harvard journal of minority public health, has been a guest editor of the journal of law, medicine and ethics, and is a reviewer for the journal of the american association of bioethics and the humanities. her other books include infectious madness: the surprising science of how we "catch" mental illness, deadly monopolies: the shocking corporate takeover of life itself, and medical apartheid: the dark history of experimentation from colonial times to the present, which won a national book critics circle award, the pen/oakland award, and the american library association black caucus nonfiction award. a film buff and lover of baroque music, ms washington has also worked as manager of a poison-control center and as a classical-music announcer for public radio station wxxi-fm in rochester, new york, and she curates a medical-film series. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: conference@amwa.org sarah dobney, mph / amwa annual conference chair, galion, oh 2021 walter c. alvarez award recipient: harriet washington amwa journal / v36 n2 / 2021 / amwa.org 97 v37 n1 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 45 abstract for much of its history, the american medical writers association (amwa) bestowed 4 awards in honor of 4 of its members: harold swanberg, md, the founder of the association; walter alvarez, md, in retirement, a nationally syndicated health columnist; eric martin, phd, a pharmacist instrumental in professionalizing regulatory writing; and john p. mcgovern, md, a philanthropist who supported initiatives in biomedical communication. however, the details of the lives of these men are unknown to most amwa members. accordingly, this biography describes the life and accomplishments of john p. mcgovern, to recognize his achievements and to contribute to the history of the profession and of the association. john phillip mcgovern, md (1921-2007), was a physician, teacher, researcher, humanitarian, businessman, investor, and philanthropist who contributed to the fields of allergy and immunology, widely promoted sir william osler’s principles of humanistic medicine, added to the size and scope of houston’s texas medical center, and enhanced the quality of life in houston through several major gifts to the city.1 the mcgovern allergy clinic was at one time the largest private allergy clinic in the country.1 its success and mcgovern’s astute investments in stocks and real estate made him enormously wealthy, wealth that he then donated liberally to support dozens of projects that furthered the advancement of medicine and community life. the john p. mcgovern foundation, now headed by his wife, kathy, continues to support several worthwhile projects. in the american medical writers association, the john p. mcgovern award, funded in 1985 by a grant from the mcgovern foundation, “is presented to a member or nonmember of amwa to recognize a preeminent contribution to any of the various modes of medical communication.”2 the range of candidates and the nature of the contributions suitable for this award is consistent with john’s own wide range of interests and causes. (from the author: unless otherwise noted, all information here comes from john p. mcgovern, md,1 a definitive biography written by his friend, bryant boutwell, drph. this biography is the source of many other accounts of his life.) growing up in washington, d.c. john (jack, to his friends and family) was born in washington, dc in 1921, the only child of francis xavier mcgovern, a surgeon in the us public health service, and lotti brown mcgovern, a most competent housekeeper and gracious hostess. he was also very close with his maternal grandmother, “granny brown,” the kind of woman who would (and did) open her kitchen during the republican great depression to feed families in need. in addition, his second cousin, the actress helen hayes, seemed to have been both a confidant and an inspiration to him. the close and supportive nature of the mcgovern, brown, and hayes families provided several role models of nurturing, hard work, enjoyment, and caring for others. even in childhood, john was unusually deliberate, careful, perfectionistic, and above all, driven. as a boy, he liked baseball, football, soccer, stamp collecting (he eventually sold his collection to pay for college expenses), fishing, camping (he was a boy scout), and playing marbles. not the informal play that many children enjoy from time to time, but, as he told his biographer, the “real game of marbles—ringer. a 10-foot circle with 13 marbles in a cross at its center. i’m talking lag lines, pitch lines, and knuckling down to knock the most marbles at center from the ring.” in fact, his approach to marbles is telling. at age 9, john spent long hours shooting marbles until he was very skilled. tom lang / principal, tom lang communications and training international, kirkland, wa john p. mcgovern, md – physician, entrepreneur, philanthropist biography john p. mcgovern, md. http://www.amwajournal.org amwajournal.org 46john p. mcgovern, md–physician, entrepreneur, philanthropist he, like most boys, played with marbles made of cheap glass. however, some marbles are made of quartz—the prized agates—and john was set on collecting agates. he hit on a strategy that involved an attractive challenge. he would bet a bottle of glass marbles against 1 or 2 agates. few boys could resist the possibility of winning so many marbles, even if they were glass. john’s strategy worked—within a year, he owned most of the agates in the neighborhood. the story illustrates the traits he would carry into adulthood: competitiveness and confidence, thoughtful and careful planning, hard work and discipline, and collecting and preserving things of value. medical training after graduating high school in 1939, john matriculated into duke university in durham, north carolina. he began medical school in 1942, after completing 3 years of pre-med courses. duke did not require a bachelor’s degree for admission to medical school, but students could earn a bachelor’s degree in medicine en route to the doctorate in medicine if they conducted research while in medical school, an option john would take. entrance to medical school, of course, involved an interview. in this case, john’s interviewer was wilburt davison, md, the founding dean of the medical school and a rhodes scholar. for john, the interview marked the beginning of medical school and of an important and lifelong friendship. at oxford, dr davison had studied with sir william osler, considered by many to be the founder of modern medicine. the mentorship of dr davison and the legacy of sir william osler would profoundly affect john throughout his life. john loved medical school. the intensity of an accelerated program, the complexity of the topics, and the long days and short nights challenged him intellectually and physically. he was also becoming interested in research, and not just because it would complete his bachelor’s degree. duke was one of many universities that offered the borden prize for medical research, which was awarded to medical students with the best original research project completed in the final year of study. (the award was created by the borden, the one who developed condensed milk just before the civil war and started what became the borden food company. the company ceased operations in 2001.) the $500 prize (about $7,500 today) was actually less important than the prestige of winning the award. john, who was becoming interested in pediatrics, decided to study a particular aspect of pertussis. before bacteriologists pearl kendrick, scd and grace eldering, phd developed a vaccine, pertussis was the deadliest childhood disease at the time. however, in the early 1940s, the vaccine was given only to children older than 6 years. john helped develop a test to determine whether infants 3 to 6 months old would produce antibodies to the bordetella pertussis bacterium and thus be eligible for the vaccination.3 this award made john duke university’s first recipient of the borden award. from then on, he always found time to conduct his own research as part of his practice of medicine. postgraduate training and teaching from duke, john —now john p. mcgovern, md—began an internship in pediatrics at yale-new haven general hospital in 1945. after the first year, however, he was called for active duty in the us army and served in veterans’ hospitals from 1946 through 1948. during this time, he worked in rehabilitation medicine during the day and worked at night helping 2 local pediatricians in private practice, an experience he enjoyed and would come back to later in life. after leaving the army in 1948, john returned to duke to complete a residency in pediatrics. eventually, dean davison offered him a fellowship that included a year of study in europe, first at guy’s hospital in london, then at the hôpital des enfants malades in paris. during this year, he developed a strong interest in the history of medicine, which in 1996 would result in a bequest that established the john p. mcgovern historical collections and research center at the texas medical center library. when john returned from his year abroad, he had received probably the best training in pediatrics at the time. in 1949, he accepted a position at the george washington university school of medicine. a year later, he was an assistant professor and chief of pediatrics at the university’s affiliated hospital, the children’s hospital of the district of columbia. in 1951, he received a rare and coveted john and mary r. markle scholar award. in its 22 year history, the award was given to only 500 physicians. the 5 year, $30,000 award covered research expenses for talented young physicians who wished to stay in academic medicine rather than move into private practice. however, his increasing workload at the hospital and especially administrative tasks meant less time for research and more time completing paperwork. it took the threat of a promotion that would mean even more paperwork to persuade him to take his award and move on. once again, dr davison worked the networks and discovered an allergist at tulane university in new orleans who was looking for someone with john’s training. so, in 1954, john took a position as assistant professor at tulane university and went to work in charity hospital. http://www.amwajournal.org amwajournal.org 47john p. mcgovern, md–physician, entrepreneur, philanthropist charity hospital had been providing indigent care in new orleans since 1736. moved and rebuilt several times, it was chronically underfunded. the situation was made worse in the 1930s when the governor decreed that the hospital would serve all of the state’s indigent patients. in 1936, the hospital logged almost 75,000 admissions, making it the busiest hospital in the country with some of the most challenging patients. some 20 years later, in the mid-1950s, the workload was better but remained heavy. the hospital had 3,300 beds but treated as many as 4,500 patients on a given day. children were put 2 to a bed, and adults were put on gurneys between standard beds, so a 20-bed ward functionally became a 40-bed ward. the outpatient clinic saw 5,000 patients a day. still, john was able to conduct his markle-related research after hours, although it made the days much longer, and he enjoyed his colleagues, who were dedicated physicians carrying the same workload. during this period, he decided to become an allergist and passed the american medical association’s board examination without any advanced training in the field—then and now, a rare accomplishment—making him board-certified in both pediatrics and allergy. he remained at tulane until 1956, when a favorite professor from medical school asked him to come to houston where the potential for patient care, teaching, and research was good and getting better. so, at age 35, john moved to houston. the mcgovern allergy and asthma clinic in the 1950s, flush with oil money, houston was a rapidly growing city that attracted talented people from several fields, especially medicine. the m. d. anderson hospital and tumor center (now the university of texas m. d. anderson cancer center), the baylor college of medicine, the university of texas dental school at houston, baylor st. luke’s medical center, rice university, and texas children’s hospital, among other institutions, were in various stages of development. when john bought the practice of a retiring allergist, the mcgovern allergy clinic was born. the practice flourished. soon, the increased number of patients required hiring additional physicians. their job interviews, all conducted by john himself, often went for 2 hours or more, and some applicants had 2 or even more interviews. during these interviews, they learned about john, dr davison, duke university, and osler’s approach to medicine, among other things. the result of this hiring process was a close-knit staff of pediatric allergists who shared osler’s approach to medicine and john’s work ethic. during this period, he also formed the texas allergy research foundation. one new employee caught john’s attention. hired as an office manager, kathy galbreath proved a most capable worker who could also cope with her employer’s perfectionism and work schedule. the 2 were married in 1961. when asked to name the highlights of his life, john would provide a standard answer: his friendship with dean davison, the influence of osler, the day he quit smoking in 1963, the day he quit drinking in 1984, and his marriage to kathy. but, he always added, “not necessarily in that order.” john initially held faculty appointments at baylor college of medicine and at the university of texas postgraduate school of medicine. he eventually served for 22 years as chief of the pediatrics department’s allergy section at baylor and for 16 years as chief of allergy services at texas children’s hospital. he was also a professor at the university of texas at houston and chair of the university’s department of the history of medicine. after 15 years, thanks to quality care and good business practices, the mcgovern clinic had become the largest private allergy clinic in the country.4 john also shrewdly invested in real estate, at one time owning much of the land that would eventually be occupied by the world’s largest medical complex, the texas medical center. (today, the center occupies nearly 2 square miles, is home to some 60 institutions, and employs more than 100,000 people.)5 in addition, he also successfully invested in stocks, eventually becoming quite wealthy. in 1961, he had created what would become the john p. mcgovern foundation with $10,000. at the time of his death, the foundation had $180 million in assets. professional contributions in addition to practicing medicine, john remained a committed educator and researcher throughout his career. he wrote more than 250 articles and 26 books in the medical sciences and humanities, was president or chief elected john p. (1921-2007) and kathrine g. mcgovern. (used with permission from the john p. mcgovern foundation.) http://www.amwajournal.org amwajournal.org 48john p. mcgovern, md–physician, entrepreneur, philanthropist officer of 15 professional medical societies,6 served on the editorial boards of numerous journals, and received dozens of awards. during 1968 to 1969, john was president of the american college of allergists (now the american college of allergy, asthma, and immunology) and was editor-in-chief of the college’s journals. during his presidency, the college was struggling to achieve a new status as an independent medical specialty, with its own special training requirements and board-certification process. john was instrumental in directing the development of the college’s application to american medical association’s advisory board for medical specialties. the field became a certified specialty in 1974. in the late 1960s, john and a washington, dc physician named alfred henderson independently became concerned that the emphasis on science in medical education would supplant the study of the humanities. when dr davison brought the 2 men together, they founded the american osler society in 1970 to memorialize osler’s life and teachings. the john p. mcgovern academy of oslerian medicine was created in 2001 with a $5 million gift to provide endowments for 5 william osler scholars, an amount later augmented with a second gift of $2.5 million. also, in the tradition of sir william osler, john worked to support medical libraries. in 1970, he was appointed by president richard nixon to the board of the national library of medicine. he was chairman of the board of regents of the library from 1970 to 1974 and chaired the external grants program after leaving the board. he also served on the national advisory council of the national institute of alcohol abuse and alcoholism from 1987 to 1991. several awards have been established in his name, among them, the houston academy of medicine’s john p. mcgovern compleat physician award and from the office of the president of the university of texas medical branch, the annual john p. mcgovern lifetime achievement award in oslerian medicine. philanthropic activities john was as skillful in giving money away as he was in making it. the john p. mcgovern foundation continues to fund scholarships, lectureships, endowed professorships, distinguished faculty awards, and buildings to advance medical science throughout the country. it donated $6.5 million to create a new mcgovern-davison children’s center at duke university and $75 million to the university of texas health science center at houston (uthealth) and its medical school, which was renamed the john p. and kathrine g. mcgovern medical school.7 the foundation funded uthealth’s mcgovern center for humanities and ethics and the mcgovern historical center, which houses collections on the history of medical specialties, texas medicine, north american public health, the development of the institutions and hospitals in the texas medical center in houston, and biographical information on texas physicians. the foundation has also endowed 26 annual award lectureships at universities in texas and elsewhere, including duke, harvard, yale, the c. everett koop institute at dartmouth college, and green college at oxford university. the foundation has also established several public houston landmarks, including mcgovern lake and the john p. mcgovern children’s zoo in hermann park, and • the american medical association’s special award for meritorious service. • the william a. howe award, the highest honor given by the american school health association • a private sector initiative commendation, bestowed by president ronald reagan, for his lifetime of service in medicine and philanthropy • the outstanding scholarship in health care award from the american association of colleges of nurses • the surgeon general’s medal for his lifetime of service, bestowed by dr c. everett koop, at the time, the surgeon general of the united states • the r. brinkly smithers gold medal award for outstanding work and support in the field of alcoholism and drug abuse, from the national council on alcoholism and drug dependence • the maurice hirsch award for philanthropy • the royal medallion of the polar star from sweden • l’ordre national du mérite from france • the kemal atatürk gold medal distinguished service award bestowed by the government of turkey, and the first received by an american citizen • houston’s 2001 distinguished citizen of the year • the distinguished alumnus award from duke university • fellow, american association for the advancement of science • fellow, american college of physicians • honorary fellow, royal college of physicians • distinguished fellow, american association of allergy, asthma, and immunology • fellow, american society of addiction medicine a member of amwa’s southwest chapter since 1961, john became an amwa fellow in 1967 and received the association’s highest honor, the harold swanberg distinguished service award, in 1988. box. prestigious awards received by john during his 43 year career1,6 http://www.amwajournal.org amwajournal.org 49john p. mcgovern, md–physician, entrepreneur, philanthropist was a major donor in the early days of what became the mcgovern museum of health and medical science. in 2017, a $20 million endowment created the kathrine g. mcgovern college of the arts at the university of houston,8 the first college in the university to be named after a former student and also the first to be named after a woman. closing by all accounts, john was a talented physician, teacher, and researcher. he was also personable, foresighted, deliberate, driven, and above all, generous with his time as well as with his fortune.9 he made life better for hundreds of thousands of children, medical students, patients, colleagues, and members of the public. in so doing, he, as always, was taking one of osler’s principles to heart, “we are here to add what we can to life, not to get what we can from life.”10 author declaration and disclosures: the author reports no commercial associations that may pose a conflict of interest in relation to this article. author contact: tomlangcom@aol.com references 1. boutwell b. john p. mcgovern, md: a lifetime of stories. texas a&m university press; 2014. 2. american medical writers association. mcgovern award. american medical writers association website. accessed january 11, 2022. https://www.amwa.org/page/recognition 3. mcgovern jp. passive intraperitoneal mouse protection test in a study of immune response to h. pertussis vaccination. pediatrics. 1950;5(1)38-44. 4. about mcgovern: john p. mcgovern academy of oslerian medicine. utmb website. accessed january 11, 2022. https://www.utmb.edu/osler/about/about-mcgovern 5. about us. texas medical center website. accessed january 11, 2022. https://www.tmc.edu/about-tmc 6. medical library association. mcgovern, john p. medical library association website. accessed january 11, 2022. https://www. mlanet.org/blog/mcgovern-john-p 7. mcgovern medical school. john p. mcgovern foundation renames mcgovern medical school. ut health website. accessed january 11, 2022. https://med.uth.edu/mcgovern-info/ 8. university of houston. a college of the arts for a city of the arts. university of houston website. accessed january 11, 2022. https://www.uh.edu/kgmca 9. in memoriam. john p. mcgovern, md, 1921-2007. ann allergy asthma immunol. 2008;100(2):104-105. https://doi.org/10.1016/ s1081-1206(10)60417-6 10. osler w. osler’s “a way of life” and other addresses, with commentary and annotations. hinohara s, niki h, eds. duke university press; 2001:301. #amwa2022 | save the date! www.amwa.org/conference save the date elevating health and well-being through medical communication. 2022 amwa medical writing & communication conference november 2-5, 2022 denver, co trends and opportunities for medical communicators join us november 2-5, 2022 in denver, co. gain new perspectives and reach new heights in medical writing and editing. • advancing medical communication and building value • emerging trends in the regulatory writing environment • health communication strategies for elevating health literacy • medical writing and editing for continuing education in the health professions • preparing the next generation of medical writers and leaders • progress and developments in scientific publications • technology and innovation in medical communication • the medical communicator’s role in diversity, equity, and inclusion #amwa2022 education sessions will include timely and topics such as #amwa2022 www.amwa.org/conference http://www.amwajournal.org https://www.amwa.org/page/recognition https://www.tmc.edu/about-tmc https://www.mlanet.org/blog/mcgovern-john-p https://www.mlanet.org/blog/mcgovern-john-p https://med.uth.edu/mcgovern-info/ https://www.uh.edu/kgmca https://doi.org/10.1016/s1081-1206(10)60417-6 https://doi.org/10.1016/s1081-1206(10)60417-6 110 amwa journal / v36 n3 / 2021 / amwa.org abstract given their potential for engaging audiences, there has been increasing interest recently in the use of digital enhancements, such as video abstracts and infographics, for primary publications in peer-reviewed medical journals. however, their uptake by authors and sponsors of medical publications has been mixed, with few top journals offering the possibility of publishing digital enhancements beyond supporting slides and lay summaries. digital enhancements for primary manuscripts may provide new opportunities for medical writers to expand their skills and services, but it is unclear whether medical writers receive and accept requests to develop digital enhancements regularly and what training they need to generate high-quality deliverables for their clients. understanding the perspectives of medical publication professionals and their clients on digital enhancements for peer-reviewed journals may help address misconceptions and concerns and identify more effective ways to create auxiliary digital content to support the dissemination of research findings. here, a survey was conducted to gauge the overall interest in accompanying digital enhancements among medical publication professionals and their perception of their clients’ needs, determine the perceived value of these features, and identify barriers in development. the survey was created and posted on amwa engage, amwa new england chapter e-news, linkedin, and the medcomms networking webpage. a total of 116 respondents completed the survey. about half had developed digital enhancements for primary publications, mostly for pharmaceutical companies, medical communication agencies, and other nonacademic organizations. infographics and visual abstracts were the most frequently requested type of enhanced content. although the respondents recognized the importance of digital enhancements to facilitate data visualization, approximately half reported not having specific training or experience to enable them to accept such assignments. for their clients, the main reasons given for not developing digital enhancements were cost and time constraints, lack of interest, and author unavailability. the medical literature is essential to the communication of scientific evidence. in the past few decades, traditional print journals have predominantly assumed electronic formats, allowing for wider access and outreach, and social media and digital tools are now important vehicles in content dissemination.1 a digital enhancement in the context of scientific publications is an online feature that is developed to aid in the visualization and interpretation of data. infographics have been used for quite some time, particularly in patient education materials, and are effective channels for the communication of complex concepts. infographics typically combine text with graphics, illustrations, and/or charts in a logical sequence to tell a story.2,3 examples of infographics can be found here in https://www.fda.gov/media/82381/download and https:// www.who.int/reproductivehealth/publications/violence/vaw_ infographic.pdf?ua=1. visual or graphical abstracts are schematic or animated representations of the content of an article, require less time and effort to create than infographics, and can be easily shared on social media.4,5 for examples of visual abstracts, see https://www.nejm.org/doi/full/10.1056/ nejmoa2026845?query=featured_home and https://www.cell. com/cancer-cell/fulltext/s1535-6108(21)00339-1. video formats have become very popular with the widespread availability of mobile and relatively inexpensive filming/recording devices.6 different types of video abstracts can be viewed here: https://www.youtube.com/watch?v=vnig0pah3we, https:// players.brightcove.net/656326989001/default_default/index. html?videoid=5824269862001, and https://player.vimeo. com/video/301841421. in addition, “twitter abstracts” (visual abstracts that are disseminated via twitter) are gaining traction patricia fonseca, phd, cmpp / medical writer/translator, cambridge, ma digital enhancements for primary medical manuscripts: a survey on perceptions, challenges, and needs of medical publication professionals r e s e a r c h https://www.fda.gov/media/82381/download https://www.who.int/reproductivehealth/publications/violence/vaw_ https://www.who.int/reproductivehealth/publications/violence/vaw_infographic.pdf?ua=1 https://www.nejm.org/doi/full/10.1056/nejmoa2026845?query=featured_home https://www.cell.com/cancer-cell/fulltext/s1535-6108(21)00339-1 https://www.youtube.com/watch?v=vnig0pah3we https://players.brightcove.net/656326989001/default_default/index https://players.brightcove.net/656326989001/default_default/index.html?videoid=5824269862001 https://player.vimeo.com/video/301841421 https://player.vimeo.com/video/301841421 amwa journal / v36 n3 / 2021 / amwa.org 111 as a rapid means of disseminating research findings to a wider audience.7 written lay summaries are digestible forms of presenting data to patients, nonspecialist health care providers, or the public. lay summaries require no expertise in terms of graphic design and have been embraced by several publishers as important elements of research articles.8-10 examples of different formats of lay summaries can be found in https:// www.acpjournals.org/doi/10.7326/p21-0006 and https://link. springer.com/article/10.1007/s13300-018-0531-0#sec1. other digital enhancements accepted by biomedical journals include audio abstracts, which are voice recordings summarizing an article, and interviews with the authors, in either video or audio format, in which the authors have a conversation with an interviewer about their research findings. for audio and video interviews, see https://jamanetwork.com/journals/ jamaophthalmology/pages/jama-ophthalmology-authorinterviews and https://www.mayoclinicproceedings.org/ video-archive-2021. given their ease of access and potential for engaging audiences,11-13 there has been increasing interest in recent years in the use of digital tools for data dissemination, and this interest was greatly amplified by the covid-19 pandemic and the increase in virtual congresses. regarding primary publications in peer-reviewed medical journals, the uptake of digital enhancements by authors and/or pharmaceutical companies sponsoring the development of scientific publications has been mixed. digital enhancements for primary manuscripts may provide new opportunities for medical writers to expand their skills and services. understanding the main advantages and limitations of digital features may help address misconceptions or concerns about the development of auxiliary digital content to enhance the communication of research findings. the main objective of this survey was to gauge the overall interest and demand for accompanying digital enhancements among medical writers and other publication professionals. the secondary objective was to determine the perceived value of digital enhancements and identify barriers to their development. methods a survey targeting medical writers and other professionals involved in the development of primary manuscripts for peerreviewed journals was developed using google forms. the 25-question survey, which took no longer than 10 minutes to complete, was shared on amwa engage, the amwa new england chapter e-news, and the linkedin pages of amwa, the amwa new england chapter, medcomms networking, the publication plan, and the medical writers corner. in addition, the survey was disseminated directly in the medcomms networking online newsletter. permissions to advertise the survey were requested as needed. responses were accepted from august 25, 2020, to june 1, 2021. the survey included 24 multiple-choice questions and a comment box (question 25) to collect feedback from respondents. some questions allowed for more than one answer to be selected. all questions allowed respondents to add in their answers, if different from the choices provided; there were no mandatory questions. information captured in the survey included demographic data (ie, region, role, therapeutic areas, and years of experience), the number and type of enhancements developed, the perceived benefits and main obstacles encountered before and during the development of digital enhancements, and metrics deemed relevant to evaluate their impact. awareness, interest, and determining factors in the decision-making process were assessed for academic compared with nonacademic sponsors and/or authors. the complete survey is included as a supplement. results as of june 8, 2021, a total of 116 responses had been received; the majority of the respondents were based in europe (59%) and north america (35%). the top 3 roles (n = 114) were medical writers (66%), publications planners (29%), and editors/ proofreaders (25%) (more than one option could be selected). the vast majority of respondents (97%) were employed or worked as freelancers, and most worked full-time (72%); 62% had more than 10 years of work experience, and only 3% reported having less than 2 years of experience in the field. the most common therapeutic areas (n = 114) in order of prevalence were oncology (52%), neurology (28%), respiratory diseases (26%), and cardiology and endocrinology (approximately 24% each) (more than one option was allowed). the majority of the respondents were employed by medical communication agencies or contract research organizations (37%) or worked as freelancers (35%); a small portion of respondents were affiliated with academic institutions and other medical and educational organizations (10%) (figure 1). 18% 37% 3% 35% 7% pharmaceutical/biotechnology and medical devices company medical communications agency/ contract research organization academia freelancer other* figure 1. survey population per professional setting (n = 116). *includes medical societies, journal publishers, and nonprofit research and/or educational organizations. https://www.acpjournals.org/doi/10.7326/p21-0006 https://www.acpjournals.org/doi/10.7326/p21-0006 https://link.springer.com/article/10.1007/s13300-018-0531-0#sec1 https://jamanetwork.com/journals/jamaophthalmology/pages/jama-ophthalmology-author-interviews https://www.mayoclinicproceedings.org/video-archive-2021 https://link.springer.com/article/10.1007/s13300-018-0531-0#sec1 https://www.mayoclinicproceedings.org/video-archive-2021 112 amwa journal / v36 n3 / 2021 / amwa.org more than half of the respondents (53%) had developed digital enhancements professionally (ie, created the concept, produced content, or reviewed the deliverables). of these (n = 62), the majority provided these services for clients in the life sciences or medical communication industry (92%). among respondents who had not developed enhancements for primary manuscripts (n = 55), only a small proportion (7%) reported not having an interest in doing so. for respondents with digital enhancements in their professional portfolios, 37% typically worked on 1-2 of these types of projects per year, with 28% indicating working on more than 5 enhancements in 1 year. a total of 49% reported receiving more requests for developing enhancements during the covid-19 pandemic, and 49% saw no change in these requests (n = 63). the most frequently developed enhancements (n = 62) were infographics/illustrations (76%) and visual/video abstracts (74%) (more than one option was allowed) (figure 2). the perceived benefit of digital enhancements by medical communication professionals (n = 115) was improved data visualization and comprehension (60%), followed by increased interest in primary publication (21%) and increased access (13%). for the clients, as reported by the respondents (n = 102), the value of digital enhancements was to stimulate interest in the primary publication (36%), to increase data access to a wider audience (29%), and to improve data visualization and comprehension (22%). approximately 5% of the respondents did not see a benefit but noted that their clients inquired about these enhancements because they were a requirement provided by the target journals of the primary publications. although respondents working for nonacademic clients (n = 66) reported that their clients mostly rejected proposals to develop digital enhancements because of cost (73%) and time (49%) constraints, concerns about enhancements being perceived as promotional (34%) were also reported. clients in the academic or nonprofit sector (n = 26) mostly reported to the respondents about concerns related to the unavailability of authors (69%), concerns about the time needed to develop enhancements (50%), and concerns about the associated costs of development and publication (42%). the unavailability of peer review or specific metrics for enhancements were only deemed relevant for clients in the nonacademic setting (table). approximately 63% of the respondents (n = 114) reported proposing the development of digital enhancements to clients; of those who suggested (n = 70) enhancements depending on the type of project or whenever applicable to the manuscript, the majority (79%) suggested these features to nonacademic clients only. the main barriers for medical communication professionals (n = 109) in the development of accompanying digital features were a lack of specific training and/or experience (45%), a lack of time or insufficient pay (21%), and unclear/absent instructions from the journal (20%) (figure 3). not surprisingly, 46% claimed they would accept this type of assignment if they had adequate training, with 26% mentioning better guidance from journals regarding the requirements for submission of enhancements and 16% noting the importance of special pay rates to accept these services (n = 110). respondents (n = 108) thought that adequate dissemination of the enhancement with the manuscript (eg, visible link next to the manuscript) would be the determining factor in the figure 2. most frequently developed digital enhancements (n = 62). more than one option could be selected. *summary slides with audio commentary. **video or animated abstract with/without voice-over and/or images/charts. 45% 20% 21% 14% 23% 47% 74% 76% interview with author(s) audio slides* visual abstracts** infographics/illustrations table. reasons for rejecting digital enhancements industry clients (n = 66) nonindustry clients (n = 26) no perceived value 12% 15% may be perceived as “promotional” 34% 4% journal does not offer peer review 9% 0% copyright issues related to enhancement 21% 4% insufficient dissemination by journal (eg, link not easily visible) 14% 8% hosted externally to journal (eg, commercial video platform) 12% 4% journal does not collect specific metrics 6% 0% cost (eg, production costs, journal fees) 73% 42% time and resources needed for development 49% 50% authors unavailable 27% 69% a maximum of 3 options could be selected. industry clients: pharmaceutical, biotechnology, or medical device companies, contract research organizations, or medical communications agencies. nonindustry: academia, medical societies, or individual authors. amwa journal / v36 n3 / 2021 / amwa.org 113 decision to develop digital enhancements for nonacademic clients (64%), which was followed in importance by the availability of useful metrics specific to the enhancement (50%). however, for those providing services to clients in academia and nonprofit entities (n = 60), journal assistance (60%), adequate dissemination (48%), and no or reduced fees for hosting the enhancement (47%) were referred to as factors that could influence a decision to develop enhancements. the most relevant enhancement-specific metrics for medical publication professionals (n = 113) were the total number of views/downloads (56%) and the time spent viewing the enhancement (30%); 55% of the respondents reported they would use the total number of views/downloads as a measure of the impact of digital enhancements to promote this type of service to clients. in the open-ended responses, the respondents recognized that demand for digital features will continue to grow and specifically mentioned the difficulties in demonstrating the overall benefit compared with the cost to clients as well as issues related to open access and copyright. discussion this survey was conducted to learn about the impact of digital enhancements on the practices of professionals involved in the development of primary publications, and the responses obtained provided a glimpse of the challenges encountered in the field of biomedical publications. despite the current interest in digital formats, which has been intensified by the covid-19 pandemic, and increasing research attempting to measure their value, digital enhancements for peer-reviewed primary publications do not seem to have a significant presence outside the context of medical communication agencies and sponsors of scientific publications in the life sciences industry. although sponsors seem to recognize digital features as effective means of disseminating scientific data, there are oftentimes issues to address that do not relate to content or the choice of the most adequate format for the data in question, namely the journal’s capacity for hosting enhancements and requirements, the timing of submission of the enhancements, the availability of peer review, the visibility of the enhancements, and copyright licensing. for medical publication professionals, accepting requests to develop these features may involve advising hesitant clients or authors, discussing benefits and concerns, and integrating the development process for digital features into the timeline for the core manuscript. some journals may request the submission of an enhanced content piece with a manuscript, but if the manuscript is rejected, the enhancement developed may not be in the correct format for another journal. for these reasons, clients and authors may see enhanced features as a poor use of their time and budgets. in addition, different practices by journals in terms of how digital enhancements are displayed on their websites (eg, as supplementary materials, as links to external websites, or prominently displayed with the article) may hinder access. authors also face barriers to sharing digital content online, as the copyright license for the enhancement may be owned by the journal. moreover, nonacademic sponsors may have restrictive policies on sharing content online, which may partially explain the low level of engagement of academic coauthors in the development of enhanced digital content in these industry-sponsored publications. authors, sponsors, and medical communicators alike would certainly benefit from having detailed guidance, assistance, and quantitative data from journals hosting digital enhancements. finally, there is currently a lack of evidence regarding the best strategies to effectively disseminate data and engage the target audience through digital channels. in the future, digital enhancements may be as standard as traditional written abstracts in journal articles, ultimately benefiting their audiences. limitations this study had some limitations. first, there was selection bias owing to how the survey was advertised to medical publication professionals. most respondents were experienced professionals who may have had a distinct exposure to this type of publications compared with less “seasoned” professionals. in addition, the survey may have captured the responses of those already developing or with an interest in developing digital features. second, biomedical publication professionals from other geographic regions other than europe and north america as well as professionals working in nonprofit, academic, and educational backgrounds were poorly represented, which may be 45% 20% 21% 14% no specific training experience no clear or absent instructions from journal lack of time or insufficient pay other figure 3. main barriers for medical communications professionals (n = 109). a maximum of 3 options could be selected. 114 amwa journal / v36 n3 / 2021 / amwa.org explained by the only relatively recent rise in medical writing services in asia14 and the traditionally low presence of these professionals at research centers and universities. finally, the open-text format of some of the questions added a level of complexity to the analysis of the responses, as some of the answers added were the same as the ones provided, but with different wording, and others did not fit into the context of the questionnaire (eg, interactive posters for congresses). conclusion digital enhancements may add value to primary publications, but many barriers persist and hinder a wider uptake by medical communication professionals and their clients. although nonacademic clients may be particularly concerned about the return on investment, the cost and time invested in the development of these features pose challenges to both academic and nonacademic clients. medical communication professionals are uniquely positioned to provide clients and authors with much needed support in creating visual and digital enhancements for publications, but confidence in their own expertise to guide the development process falls below expectations. professional societies such as amwa could potentially contribute to meet the needs for specific training in the development of digital enhancements in the form of continuing education activities. acknowledgment the author thanks all the respondents for their valuable feedback and comments and thanks pete llewellyn for disseminating the survey in the medcomms networking online newsletter. author declaration and disclosures: patricia fonseca is an employee of excerpta medica. this survey was conducted independently. the opinions expressed in this article are those of the author. the author received no honorarium, fee, or other form of financial support related to the development of this article. preliminary data collected from this survey were presented as a poster at the amwa 2020 medical writing & communication conference held in october 2020 and as part of a webinar titled “extending the reach of medical publications: working on digital enhancements in practice,” which was organized by medcomms networking and held on may 26, 2021. author contact: pfonsecamedical@gmail.com references 1. dash a, docking m, donnelly r, et al. scholarly publishing in the digital era. wiley website. accessed june 30, 2021. https://www.wiley.com/ network/professionals/healthcare-publishing-trends/396901-a4-wppublishing-in-the-digital-era 2. smiciklas m. the power of infographics: using pictures to communicate and connect with your audiences. pearson education; 2012. 3. chicca j, chunta k. engaging students with visual stories: using infographics in nursing education. teach learn nurs. 2020;15(1):32-36. https://doi.org/10.1016/j.teln.2019.09.003 4. ibrahim am, keith l, klingensmith me, et al. visual abstracts to disseminate research on social media: a prospective, case-control crossover study. ann surg. 2017;266(6):e46-e48. https://doi.org/10.1097/ sla.0000000000002277 5. ibrahim am, ed. use of a visual abstract to disseminate scientific research. version 4. squarespace website. published january 2018. accessed june 30, 2021. https://static1.squarespace.com/ static/5854aaa044024321a353bb0d/t/5a527aa89140b76bbfb20 28a/1515354827682/visualabstract_primer_v4_1.pdf 6. co-design of video-abstracts for scientific publications. audiovisualresearch.org website. published september 2017. accessed june 30, 2021. https://www.audiovisualresearch.org/science-film/ validity-of-video-abstracts/ 7. hartley j. what’s new in abstract of science articles. j med libr assoc. 2016;104(3):235-236. https://doi.org/10.3163/1536-5050.104.3.011 8. king sr, pewsey e, shailes s. plain-language summaries of research: an inside guide to elife digests. elife. 2017;6:e25410. https://doi. org/10.7554/elife.25410 9. anstey a. plain language summaries in the british journal of dermatology: connecting with patients. br j dermatol. 2020;170(1):1-3. https://doi.org/10.1111/bjd.12760 10. dormer l, walker j. plain language summary of publication articles: helping disseminate published scientific articles to patients. future oncol. 2020;16(25):1873-1874. 11. bredbenner k, simon sm. video abstracts and plain language summaries are more effective than graphical abstracts and published abstracts. plos one. 2019;14(11):e0224697. https://doi.org/10.1371/ journal.pone.0224697 12. huang s, martin lj, yeh ch, et al. the effect of an infographic promotion on research dissemination and readership: a randomized controlled trial. cjem 2018;20(6):826-833. https://doi.org/10.1017/cem.2018.436 13. chapman sg, grossman rc, fitzpatrick meb, brady rrw. randomized controlled trial of plain english and visual abstracts for disseminating surgical research via social media. br j surg. 2019;106(12):1611-1616. https://doi.org/10.1002/bjs.11307 14. cooper j. medical writing services in asia: recent developments and trends. ochre media website. accessed june 30, 2021. https://www. pharmaceutical-tech.com/articles/medical-writing-services-in-asiarecent-developments-and-trends learn more ismpp university, “visual medical communications,” webinar presented on january 29, 2020: https://www. ismpp.org/complimentary-ismpp-u-webinars boston university, certificate in visual and digital health communications: https://www.bu.edu/academics/met/ programs/graduate-certificate-in-visual-digital-healthcommunication/ graphical abstracts: https://www.cell.com/pb/assets/raw/ shared/figureguidelines/ga_guide.pdf twitter posters: https://www.youtube.com/watch?v=fqdl8r3r_d4 plain language summaries: https://www.envisionthepatient.com/plstoolkit/ tools: canva infographic (https://www.canva.com/), piktochart (https://www.piktochart.com/), motifolio (https://www.motifolio.com/), mind the graph (https://mindthegraph.com/) mailto:pfonsecamedical@gmail.com https://www.wiley.com/network/professionals/healthcare-publishing-trends/396901-a4-wp-publishing-in-the-digital-era https://doi.org/10.1016/j.teln.2019.09.003 https://www.ismpp.org/complimentary-ismpp-u-webinars https://www.bu.edu/academics/met/programs/graduate-certificate-in-visual-digital-health-communication/ https://www.cell.com/pb/assets/raw/shared/figureguidelines/ga_guide.pdf https://www.youtube.com/watch?v=fqdl8r3r_d4 https://www.envisionthepatient.com/plstoolkit/ https://www.canva.com/ https://www.piktochart.com/ https://www.motifolio.com/ https://mindthegraph.com/ https://doi.org/10.1097/sla.0000000000002277 https://static1.squarespace.com/static/5854aaa044024321a353bb0d/t/5a527aa89140b76bbfb2028a/1515354827682/visualabstract_primer_v4_1.pdf https://www.audiovisualresearch.org/science-film/validity-of-video-abstracts/ https://doi.org/10.3163/1536-5050.104.3.011 https://doi.org/10.7554/elife.25410 https://doi.org/10.1111/bjd.12760 https://doi.org/10.1371/journal.pone.0224697 https://doi.org/10.1017/cem.2018.436 https://doi.org/10.1002/bjs.11307 https://www.pharmaceutical-tech.com/articles/medical-writing-services-in-asia-recent-developments-and-trends 182 amwa journal / v36 n4 / 2021 / amwa.org larry lynam of the amwa florida chapter graciously invited me to speak last year at one of the monthly first thursday virtual networking meetings the chapter regularly organizes. our initial focus was on how i researched and wrote my memoir, resilience: one family’s story, which was published in october 2019.1 following my presentation, we had a lively discussion on the tools i used to organize the large amount of information generated from my research to write the memoir. as the processes and tools i used in writing the memoir are equally valuable in my medical writing, i was prompted to write this article to share them with the wider amwa membership. the memoir is the story of my family, beginning with village life circa 1910 to 1920 in rural hungary, their experiences throughout the holocaust, and their journey toward rebuilding their lives in a new country that was not entirely welcoming. unlike a typical biography, my book is a collection of biographies of different family members. sources included 9 surviving family members, 8 of their children, and oral history interviews that were acquired over many years. i learned what a challenge it was to weave those overlapping stories together into a coherent and compelling whole and had to develop a new skill set, which was narrative writing. the details i gleaned felt like an overwhelming amount of material to organize—from the interviews with many of the recounted paths and experiences during the war being quite different, to research on the jewish culture and traditions of eastern european villages, to historical details of the holocaust. additionally, i searched for source documents belonging to each member of the family in order to more fully understand their lives and put events into context, which was very time-consuming and challenging. my initial foray into writing the biography did not go well. i thought i would write a chapter for each family member, telling their stories chronologically. i began with my maternal aunt. when i reached the time in her story when she was liberated from the concentration camps and became engaged to my father’s brother, i realized that there was no way that the chronological format would work, as i hadn’t introduced him earlier! it was back to the drawing board for me, with reading more memoirs and biographies. fragments of isabella by isabella leitner2 resonated with me as the most powerful memoir i had read, and it provided me a fresh approach on how to write my family’s story. i also hired experienced writers to coach me. this was perhaps the smartest decision i made. i normally write medical explainers or perspectives and was inexperienced in writing this sort of vivid, descriptive narrative usually found in novels/books. prompted by my first writing coach, i looked back at the prewar photos we were so fortunate to have and worked to describe every detail graphically. i repeatedly reinterviewed those characters in my book who were still alive to elicit memories and descriptions of their households, scents of cooking and baking, textures and colors, in order to paint a vivid picture of rural village life. my second writing coach also radically changed my perspective. i had been studiously trying to remain an objective observer narrating my family’s experiences. my coach, however, was adamant that “i” was what was missing from the story and that i needed to write about my relationships: those with my aunts and uncles as well as my perspectives and reactions to family secrets i learned during the interviews and writing. through this work, i was able to break through my writer’s block. i proceeded to write my recollections and my family’s experiences as a series of vignettes and not worry about connecting them all until later. in addition, i also used 2 important tools. the first tool was a detailed timeline noting not only what happened (births, marriages, deaths, concentration camps, immigration, etc.) but also how old each individual was at the time. a separate line for each person made identifying relationships easier. this proved invaluable in helping me understand some of the family dynamics, which were essential in fleshing out the characters and story development. i had looked at superimposing our events on historic timelines from the us holocaust memorial museum but decided that was needlessly cumbersome and added little. judy stone, md / cumberland, md members matters resilience: one family's history the skills and tools for organizing large amounts of discordant information into a cohesive story amwa journal / v36 n4 / 2021 / amwa.org 183 the second tool was using software programs to help me organize my family’s story (table). i initially just transcribed audio tapes; however, i quickly changed to using the software transana when transcribing my oral history interviews. transana is a program to help users manage and analyze large collections of media data. i preferred using transana to using a simple tape recording because it allowed me to make a searchable database of video clips based on the individuals and key words. i particularly liked that i could annotate emotions and nonverbal clues seen in the videos in the transcriptions and better visualize clips i might want to highlight in my book. i also inserted time stamps for both reference points because my initial aspiration was to make a short video for holocaust education. i did not find imovie to be as readily searchable for clips of specific topics as transana was. if writing about heated exchanges at medical conferences or debates for instance, transana might be a useful software platform because one can better analyze gestures and nonverbals. zotero was also a useful adjunct to my research. for resilience, i used it to organize genealogic details and track source documents for each person. i had tried evernote but found it harder to organize, as it felt like a large junk pile. i also found zotero easier to use than endnote and liked that it was free and open-source. i also use zotero extensively in my medical writing (figure 1). i find it helpful for annotating references, searching by keywords, and collecting small facts that i can members matters table. useful organizational software tools for medical writers software tool zotero scrivener transana best use • can import articles and bibliography information while browsing. • searchable for facts and random bites of information that an author may want to use repeatedly in articles. • can sort bibliographies into collections and tag with keywords. • for writing and rewriting. • for writing that requires many citations or referring to source documents. • can import articles without bibliography data. • for analysis: can add codes and make a database of video clips for analysis. • can insert timestamps into transcript. cost free 30-day free trial; $49 $150 ease of use easy moderate difficult available aids tutorial tutorial and videos tutorial and demonstrations website https://www.zotero.org/ https://www.literatureandlatte. com/scrivener/overview https://www.transana.com/ products/transana-basic/ figure 1. screenshot of a zotero file. on the left is the master folder, with nested folders and subfolders within it. here, parts of my coronavirus and genealogy folders are shown, with keywords below. in the center are the individual articles and notes in a folder, downloaded via a chrome extension. on the right is bibliographic data for the selected article. this can be exported into one’s writing project. https://www.zotero.org/ https://www.literatureandlatte.com/scrivener/overview https://www.transana.com/products/transana-basic/ 184 amwa journal / v36 n4 / 2021 / amwa.org readily use in a variety of medical articles (eg, details about specific infections that won’t change a great deal over time). scrivener was a third software program that proved invaluable in organizing my information and drafts. first, i made a folder for each of the major family members (“characters”). within each, i had subfolders for the following categories: childhood, prelude to war, the war years, liberation, coming to america, and later years. as i transcribed each interview tape (including timestamps), i dropped passages into the appropriate subfolder (figure 2). scrivener also made it so easy to annotate each bit of information as to its source. this was sometimes handy when people’s memories diverged, but i felt it critical to have my sources verifiable in case i was ever challenged by any holocaust deniers. my book was received with excellent editorial reviews and was adopted as a “first year read” by one college for its incoming students. i’m satisfied that i met my initial goal—my promise to my family that their stories would not be forgotten. i would still like to continue educating individuals about “othering,” teaching tolerance, and about the holocaust—messages that remain necessary now. the task of writing such a complex biography was more difficult than i had anticipated. it was a larger-than-expected undertaking because of the vast amount of details and information that had to be organized and annotated, gleaned from many hours of interviews. in my medical writing, i have to gather and review scientific publications and news reports, dissect out and analyze the details, and then reframe the story for a specific type of audience. two of the tools that i used in writing this biography— zotero and scrivener—have also served me well for years in my medical writing. they are very adaptable for an individual writer’s needs as to the level of detail one wishes to organize, and scrivener includes several formats to accommodate different writing styles. they have both helped me organize my writing and ensure the accuracy of its content. scrivener has also helped me be more efficient in my writing. i hope you will find the same to be true for you. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: drjudystone@gmail.com references 1. stone, j. resilience: one family’s story of hope and triumph over evil . mountainside md press; 2020. 2. leitner, isabella. fragments of isabella: a memoir of auschwitz. ty crowell, co; 1978. members matters figure 2. screenshot of a scrivener note. on the left, the binder is the equivalent of a table of contents with nested folders. this shows some of the files for the historical background portion of the book. there were similar folders for each person and other major topics. in the center is a sample transcript relating to my aunt learning that her brother, miklos, was still alive. the numbers in brackets refer to the transana timestamps. the pop-out box in the center shows the subfolders i created within each family member’s main folder, demonstrating the depth of organization that scrivener provides. on the right the possibility of adding keywords is illustrated, among other options. mailto:drjudystone@gmail.com amwa journal / v36 n4 / 2021 / amwa.org 145 f e a t u r e abstract in 2020, the american medical writers association established a working group to assess the value of the contribution of medical writers across the health sciences industry, including a subgroup tasked to gather data on the regulatory agency’s perspective. we invited reviewers at regulatory agencies to participate in an anonymized survey to evaluate the effect of document quality on the regulatory review process, assess awareness among document reviewers of the contribution of medical writers to the quality of regulatory documents, and identify current strengths and opportunities to optimize document quality. this article shares the survey results and discusses their implications for document quality, their impact on the regulatory review process, and the skills medical writers need to develop to bring value to this process. introduction medical writers bring value across the health sciences, taking the lead and driving efficient approaches for the delivery of high-quality medical communication documents targeted at diverse audiences including regulators, payors, physicians, and patients.1,2 however, the value of medical writing is not consistently recognized, and medical writers often still need to justify why they should have a seat at the table and be part of the team earlier in the process. medical writing departments can also be faced with insufficient budget and resource to do their best work due to a lack of understanding of the role’s value. given the many settings in which medical writers work and the variety of documents produced, it can be challenging to identify specific indicators of value. to address this issue, the american medical writers association (amwa) executives advisory council established a taskforce to define and quantify the value of medical writing. the taskforce has 3 main areas of focus: (1) perceptions of medical writer value among medical writers and their employers, (2) key topics related to medical writer value, and (3) how the regulatory agencies view document quality and the value of medical writing. this article presents the work of the regulatory agency subgroup to evaluate the effect of document quality on the regulatory review process and assess awareness among regulatory agency reviewers of the contribution of medical writers to the quality of regulatory documents. by understanding the regulator’s perspective, we hoped to demonstrate how medical writers bring value to documents submitted to regulatory agencies, to identify and refine the training needs of medical writers, and to identify areas for action for the medical writing profession and for colleagues in the biopharmaceutical industry. survey design and objectives we employed an online survey format (surveymonkey), targeted at participants who were actively responsible for document review at a regulatory agency, were managers of regulatory agency reviewers, or who had worked in a regulatory agency review role in the past 6 months. participants were eligible regardless of the specific types of documents they reviewed. we identified potential participants via contacts in our own networks, via our colleagues (eg, company regulatory department), and via contacts of the amwa executives advisory council. participants were also encouraged to forward the survey to other eligible individuals within their organization. we reached out to the united states food and drug administration, health canada, the european medicines agency, the medicines and healthcare products regulatory agency, the bundesinstitut für arzneimittel und medizinprodukte, the pharmaceuticals and medical devices julia cooper,1 lisa chamberlain james,2 joan affleck,3 brian bass,4 julia forjanic klapproth,5 dylan harris6, on behalf of the amwa value of medical writing working group / 1parexel international, dublin, ireland; 2trilogy writing and consulting, cambridge, uk; 3merck & co, inc, rahway, nj, usa; 4bass global inc, fort myers, fl, usa; 5trilogy writing and consulting, frankfurt, germany; 6takeda pharmaceutical company limited, lexington, ma, usa value of medical writing: the regulator’s perspective 146 amwa journal / v36 n4 / 2021 / amwa.org agency, the national medical products administration, and the australian therapeutic goods administration, although the agencies of those who actually participated are not identified, as the survey was anonymous. amwa provided an official invitation letter and cover email to explain that the survey was being conducted on behalf of amwa, its objective, and how the results will be used and to provide confirmation that the responses remain anonymous. being cognizant of limitations on the regulators’ availability for such a survey, we made significant effort to develop a set of 25 survey questions that we believed would capture key points from the regulators’ experience with document quality and medical writing. most of the questions were multiple choice. the survey also included a checkpoint question to eliminate participants not involved in document review, and participants were invited to take part in a follow-up interview. for the follow-up interviews, we prepared 7 questions to elaborate on the survey results. for example, some questions included “none of the above” as a response option. if many participants selected this option, we requested additional information during the follow-up interviews. after beta testing, the survey opened in april 2021 and was open through early august 2021. interim views of the data were done in may/june to confirm adequate participation. follow-up interviews were conducted during august 2021. participant profile we received 32 responses to the survey. although this was considerably higher than the anticipated response rate, the response rate was not uniform across all questions, and it was agreed that the sample size was appropriate for descriptive analysis only. in the following sections, we have highlighted where we believe the data should be interpreted with caution due to a lower response rate. the data on agency tenure and time spent reviewing documents indicated that the survey was completed by participants meeting the target profile. most had been employed at their current agency for over 5 years (figure 1) and spent at least 10% of their time reviewing documents (figure 2). participants were also asked to indicate their department or division (omitting information that could identify them or their employer). based on these responses, we were reasonably confident that we had engaged with the right people at the regulatory agencies for the purpose of this survey. impact of quality on regulator assessments medical writers will be familiar with how the work of internal and client teams is hindered when the documents they are given are poorly constructed. the survey results confirmed that the work of the regulatory reviewer is similarly impacted if documents submitted to the agency are not well written, and the responses provide important messages about the value of the medical writer. the following section also includes important information for colleagues in regulatory affairs or other functions involved in management of regulatory applications, as well as for corporate management. the majority (87%) of the participants confirmed that poor document quality impedes regulatory assessment (figure 3). of note, none of the participants disagreed that poor quality impedes document review, and the remaining 13% had no opinion. when asked whether they encounter issues related to document quality during the review process, the same percentage—87%—reported such issues either sometimes or often (figure 4). these results show that regulatory assessors receive poor quality documents for their review relatively frequently, and regulatory assessment of the document is thereby impeded. 60% 50% 40% 30% 20% 10% 0% <1 1-5 6-10 11-20 >20 years responses: 32 figure 1. how long have you been employed at your current agency? figure 2. in your current position/role, what percentage of your time do you spend reviewing documents? 35% 30% 25% 20% 10% 5% 0% 0% 1%-10% 10%-25% 76%-100%26%-50% 51%-75% responses: 32 amwa journal / v36 n4 / 2021 / amwa.org 147 to gauge whether there has been any directional change in quality of documents, the regulators were asked how document quality has changed in the past 5 years. improvement in document quality was selected by 43% of participants. this indicates that the quality of submissions is moving in the right direction. however, there is still work to be done, because almost half (48%) responded that there has been no change in quality or they were neutral/had no opinion, and 9% believed that the quality of documents submitted to their agency has declined over the past 5 years. note that at this point in the survey the participants had not yet been provided with examples of quality issues, and so these responses likely reflect the regulators’ own concept of document quality. if documents within an application are of poor quality, the regulatory reviewer may need to send the application back with questions for clarification. over half the participants (53%) said that they send over 10% of applications back or reject the application, with questions arising from poor document quality (figure 5). although 47% of participants send back or reject less than 10% of the applications, this still means that a sizeable number of applications are delayed. for applications that are ultimately approved (figure 6), 77% of the regulatory reviewers agreed or strongly agreed that poor document quality will delay the approval process. these are clear messages on how poor document quality, which is an avoidable issue if proper processes are established and led by trained professionals, impacts the applicant’s goals and, perhaps of more serious consequence, leads to patients waiting longer than necessary for new medicines. to understand whether poor quality might impact other documents in the regulatory assessment process, we asked whether a poorly written document negatively influences the review of other documents from the same applicant. almost a third (27%) of participants agreed that poor document quality figure 3. does poor document quality impede your ability to provide regulatory assessment? figure 4. how often do you encounter issues related to document quality during the review process? 100% 80% 60% 40% 20% 0% yes no neutral/no opinion responses: 23 figure 5. what percentage of applications do you reject/send back to the applicant with questions due to poor document quality? 50% 40% 30% 20% 10% 0% responses: 19 <10% 10%-25% 26%-50% >50% figure 6. for applications that are ultimately approved, a poorly written document delays the approval process. 60% 50% 40% 30% 20% 10% 0% strongly agree agree neither agree nor disagree disagree responses: 22 strongly disagree 60% 50% 40% 30% 20% 10% 0% never rarely sometimes often responses: 23 always 148 amwa journal / v36 n4 / 2021 / amwa.org could negatively influence their review of the applicant’s other documents. it should be noted that we did not define what this means in practice, eg, whether the reviewer would be likely to review the applicant’s other documents in more detail or whether this approach would carry over to documents in later submissions. the same percentage (27%) disagreed with the question, and 45% neither agreed nor disagreed. this indicates that, in some cases, poor document quality can even influence the assessor’s review of the applicant’s other documents. the survey included questions around whether the regulatory agencies collect data themselves on document quality. three participants (13%) confirmed that their agency collects such data, 35% responded that these data are not collected, and 53% did not know. when asked what the agency does with the data, one participant stated the data are reviewed, but the majority skipped the question. most participants (90%) responded that their agency does not keep a record of applicants that regularly submit poorly written documents. quality issues observed by the regulators having established that document quality has a significant effect on the regulatory assessment process, it was important to understand which kinds of document quality issues are observed by the regulators. for the questions designed to identify these quality issues, participants were provided with the following response options (figure 7). when asked to identify all quality issues encountered (figure 8), those most frequently reported by the regulatory reviewers were excessive length/repetition/verbosity, closely followed by lack of clarity. this will not surprise most medical writers, who expend great effort working with teams to produce documents that are clear and concise with well organized messages. however, these results do demonstrate that the effort invested in these aspects is warranted and necessary to meet the needs of the regulatory assessors. of note, issues such as data errors, incomplete content, broken links, and poor tables/graphs were ranked relatively low in this question, which suggests many applicants have implemented processes to catch these avoidable issues prior to document submission. in addition to the range of quality issues typically observed, we asked the regulatory reviewers to identify the one document quality issue they encountered most frequently (figure 9). excessive length/repetition/verbosity was ranked top here, too, closely followed by poor explanation of rationale. once again, avoidable issues (data errors, incomplete content, poor tables/ graphs, poor language) were ranked low or not at all. poor organization poor language usage lack of clarity poorly designed/presented tables and graphs data errors (eg, inconsistencies, transcription errors) incomplete content poor explanation of rationale excessive length, unnecessary repetition, verbose incorrect format/nonadherence to guidance broken/incorrect or insufficient crosslinks other none figure 7. examples of quality issues used in survey questions. excessive length, repetition, verbose lack of clarity poor explanation of rationale nonadherence to guidance poor organization poor language usage broken/incorrect crosslinks incomplete content data errors poorly designed tables /graphs none of the above other 20%0% 40% 60% 80% responses: 22 figure 8. which of the following issues related to document quality do you typically encounter? check all that apply. figure 9. which one of these issues related to document quality do you encounter most frequently? excessive length, repetition, verbose lack of clarity poor explanation of rationale nonadherence to guidance poor organization poor language usage broken/incorrect crosslinks incomplete content data errors poorly designed tables /graphs none of the above other 10%0% 20% 30% 40% responses: 22 amwa journal / v36 n4 / 2021 / amwa.org 149 understanding the range and frequency of quality issues will help the medical writing profession and the industry to improve processes that support document quality and to target training and skills development for authoring teams. it is also important to understand whether specific quality issues have a greater effect on the assessor’s review and application approval, regardless of how frequently they occur. poor explanation of rationale caused the greatest negative effect on review or caused the most irritation to the regulatory reviewer, with excessive length ranked second (figure 10). when asked to identify the one issue that has the greatest negative effect on application approval, the regulatory reviewers also ranked poor explanation of rationale at the top (figure 11), followed by incomplete content. poor explanation of rationale, therefore, is not only one of the most frequently observed quality issues, but also caused the most irritation to reviewers or negatively affected their review and has the greatest negative effect on approval. clear strategic presentation of rationale supported by data should be a top area of focus for the teams responsible for documents submitted to regulatory agencies. it is also interesting that, although incomplete content is not among the most frequent quality issues, the responses suggest it has a large negative effect on application approval when it does occur. it is therefore important for applicants to have rigorous processes to validate documents for completeness before submission. in converse, excessive length was ranked as the most frequent and was among the top document quality issues that cause irritation or have a negative effect on regulatory review, yet it is not among the top issues that negatively affect application approval. regulators’ perception of medical writing beyond their view of the documents themselves, we wanted to understand what the regulatory reviewers thought of medical writers, their role, and their effect on the documents sent to the regulators for review. of those who responded, 67% were familiar with the contribution of medical writers to the documents they review. importantly, 70% either agreed or strongly agreed that medical writers improve the quality of these documents, and a clear majority (87%) agreed or strongly agreed that sponsor companies with established medical writing functions and rigorous document development processes and standards produce higher quality submissions. although this last question was asked before we had given examples of quality (and so the regulatory reviewers have used their own idea of a high-quality document), the responses strongly indicate that medical writers improve quality and established medical writing functions and processes produce higher quality documents. we asked the regulators to indicate any areas where they believed that medical writers add value to regulatory documents. over 78% identified “adherence to standards,” and 71% identified “accuracy.” this was closely followed by 64% for each of the following: • clarity • completeness • explanation of rationale • formatting it is particularly reassuring that the regulatory reviewers believe that medical writers add value in the areas of accuracy, adherence to standards, and also explanation of rationale, which the previous questions had clearly identified as a key area of concern for them. however, it should be noted that this figure 10. which one of these issues related to document quality most negatively affects your review/causes the most irritation? excessive length, repetition, verbose lack of clarity poor explanation of rationale nonadherence to guidance poor organization poor language usage broken/incorrect crosslinks incomplete content data errors poorly designed tables /graphs none of the above other 10%0% 20% 30% responses: 22 figure 11. which one of these issues related to document quality has the greatest negative effect on application approval? excessive length, repetition, verbose lack of clarity poor explanation of rationale nonadherence to guidance poor organization poor language usage broken/incorrect crosslinks incomplete content data errors poorly designed tables /graphs none of the above other 10%0% 20% 30% responses: 22 150 amwa journal / v36 n4 / 2021 / amwa.org question was only answered by 14 respondents, and so the results should be interpreted with caution. follow-up interviews some of the participants indicated that they would be happy to give more detail about their survey answers. we arranged individual interviews to gather this information, which was anonymized and amalgamated and is presented below. quality issues and document type because the survey had identified quality issues in some of the documents that the regulatory reviewers receive, it was important to understand if these were most prevalent in one document type (suggesting an issue with the template or understanding of the requirements) or were seen in all of the document types received. the regulatory reviewers confirmed that quality issues were seen generally across all document types. they explained that templates or guidance cannot address all the nuances of writing these documents and so experienced writers are needed. “explanation of rationale” as the key quality issue explanation of rationale was identified as a key area of importance for the regulatory reviewers, and they explained that this was because it can take them a lot of time to interpret what the author intended to communicate. the reviewers often go back to the sponsor for clarification, but this depends on several factors: • the type of document being reviewed (eg, lack of clarity or other issues affecting safety are usually much more concerning than issues of lesser consequence) • timeline (eg, whether the reviewer has the time to work through the misunderstanding/quality issue themselves) • complexity (eg, whether the reviewer is able to work through the quality issue in the document compared with sending it back to the sponsor) • resources (eg, whether a specialist is available on the regulatory agency side to review the document to help with the quality issue) the impact of a document with a poorly written rationale can be significant. some regulatory agencies could interpret a poorly written rationale as lack of transparency, which could then call the entire application into question (a “domino effect”), and documents with poor rationales would likely be flagged at each review step for extra investigation, which would affect the whole application. it was widely accepted that a poorly written rationale makes the entire review process more difficult and would have a negative effect on approval. other document quality issues although we asked about the most common issues negatively affecting document quality, we wanted to know if the regulatory reviewers encountered other issues that we had not specified. lack of transparency was identified as a key issue, particularly if the regulatory agency had experienced challenges with the sponsor or their applications previously. a lack of transparency and lack of clarity around the sponsor’s objectives can raise regulatory reviewers’ suspicions and give the impression that the sponsor is trying to overwhelm the reviewer with a mountain of data. transparency in terms of minutes from meetings with other regulatory agencies was also required, and a reluctance to provide these documents delays approval because it takes extra time to request them. the reviewers explained that it is important for them to see the concerns and requirements in other regions. medical writers’ influence on document quality and their role we asked what influence the regulatory reviewers felt that medical writers had on document quality and the medical writer’s role. the responses were extremely heartening and reflected the aims of the medical writing profession. the regulatory reviewers felt that medical writers have a “great and positive influence on document quality; they help keep documents clear, as brief as they can be, and consistent.” they felt that there is “definitely a difference when medical writers have been involved” in document production and that they can tell if inexperienced writers have been used, as they see a lack of attention to detail and adherence to standards. the regulatory reviewers felt that “a professional medical writer is always welcome and is always needed” and believe that the importance and value of medical writers “continues to grow,” to the extent that some regulatory agencies have established their own medical writing teams. the regulatory reviewers felt that medical writers have a “great and positive influence on document quality; they help keep documents clear, as brief as they can be, and consistent.” amwa journal / v36 n4 / 2021 / amwa.org 151 one of the reviewers summed up the situation beautifully: “i know that it is a very specific profession needing training. [sometimes] we cannot tell who has written what in the applications or how much medical writers have been involved—it is invisible from the regulatory agency point of view. we don’t need to know, we just want something of good quality!” anything else? finally, we asked a very open question—were there any other comments that the regulatory reviewers would like to make concerning document quality or the role of professional medical writers? they explained that, beyond scientific expertise, medical writers should be involved in document production to make the information understandable and usable for the reviewer. they emphasized that they cannot “transform a bad document”—if the information they are given is not understandable, they cannot reply to it, which they found very frustrating because their role is to encourage and facilitate drug development. often, regulatory reviewers can see that there is excellent science and work behind the document, but because it has been written badly, they are forced to guess what the messages are. they believed that although the role and work of medical writers may not be immediately visible to them, it was a “major” contribution. their final comment was that there was “no negative in having medical writers involved in document development— their influence and contributions are always positive.” looking forward the objectives of the survey were to gain an understanding of how regulatory agencies perceive the value of medical writing and to learn where to focus the training and development of medical writers to maximize the value in, and skill set for, the preparation of regulatory documents. the survey responses showed that many regulatory reviewers understand the role of medical writers, believe that they increase the quality of the documents sent to the agencies for review, and make the job of the regulatory reviewer easier. it is unsurprising that document quality is extremely important for regulatory reviewers. participants reiterated that poor document quality can not only hamper the ability of the reviewer to provide an assessment (delaying the drug approval process), but also has the potential to bias reviewers against subsequent submission documents from the same sponsor. there is a clear opportunity for medical writers to improve document quality, and the survey responses can also be used to inform how medical writers present themselves within their organizations—quality is clearly top of the regulatory reviewers’ list of priorities and has been recognized by them as an area where medical writers add value. most satisfyingly, regulatory reviewers appreciated and recognized the work and importance of trained medical writers; thus, addressing regulatory reviewers’ needs should continue to be a priority for the profession. training must equip medical writers to lead teams that create documents that are concise and clearly present the message supported by the data. perhaps even more focus should be given to team management and soft skills to allow medical writers to lead and guide these teams so that the documents supporting submissions are as concise and strategic as possible to streamline and increase efficiency of the whole clinical development process. the fact that the regulator reviewers, who are often timepoor, chose to take the time to help us to understand the role and value of medical writers is a testament to the importance of our profession and the expertise that trained medical writers bring to the development of regulatory documents and their associated teams. acknowledgment thanks to susan krug, amwa executive director, who provided significant support setting up the survey and with communication to survey participants. author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. the opinions expressed in this article are the authors’ own and are not necessarily shared by their employers or amwa. author contact: julia.cooper@parexel.com references 1. marchington jm, burd gp. author attitudes to professional medical writing support. curr med res opin. 2014;30(10):2103-2108. 2. woolley kl, lew ra, stretton s, et al. lack of involvement of medical writers and the pharmaceutical industry in publications retracted for misconduct: a systematic, controlled, retrospective study. curr med res opin. 2011;27(6):1175-1182. mailto:julia.cooper@parexel.com contents v36 n3 fall 2021 128 a logarithm is the inverse function of exponentiation. if bn = x, then n = logb(x). since 23 = 8, log2(8) = 3. since exponents can be negative, you can have negative logarithms, which represent the inverse of a number. since ½ is the inverse of 2, the log2(½) = −1. likewise, the log10(¹⁄₁₀) = −1 (figure 1). some units of measure are based on a logarithmic scale. for example, ph is based on the negative of the base-10 logarithm of the activity of the h+ ion (as measured in moles per liter). 𝑝𝑝𝑝𝑝 = −𝑙𝑙𝑙𝑙𝑙𝑙!"(𝑎𝑎#!) = 𝑙𝑙𝑙𝑙𝑙𝑙!" , 1 𝑎𝑎#! . a solution of pure water has hydrogen activity of 1 × 10−7. the reciprocal of that is 1 ×107, or 107; log10(107) = 7. so the ph of pure water is 7. water with a ph of 6 would have a hydrogen activity of 1 ×10−6, which is 10 times as many hydrogen ions as in pure water! figure 1. logarithms are the inverse function of exponentiation: if bn = x, then n = logb(x). exponentiation allows you to raise any real number (any point along a number line) to any real power. note that x0 always equals 1, and x1 always equals x. for this reason, logb(0) is always 1 and logb(1) is always b, regardless of the value of b (i.e., regardless of the base of the logarithm). a negative exponent represents the inverse of a number (e.g., 2−1 = ½). thus, a negative logarithm equals the logarithm of the inverse of the value: log2(½) = −1 and −log2(½) = 1. courtesy of richard f. lyon via wikimedia commons. base-10 logarithms are used so often that they are often just written as log (x). the natural logarithm, abbreviated ln (x), has euler’s number (e) as its base. euler’s number is an irrational number that is useful in many different areas of mathematics. medical writers should be aware that viral load is often expressed in base-10 logarithms. i once edited a news article that described a patient as having a viral load of 5 copies/ml. that value was dubious: a value that low had to be below the limit of detection of any available assay. when i looked at the source material, i found out that the patient’s reported viral load was actually 5 log10 copies/ml, which meant 100,000 copies/ml. big difference! 121 18% 37% 3% 35% 7% 110 101 106 110 115 118 120 121 feature a cognitive model approach to creating usable health care content � kirk st.amant feature infographics and visually appealing slides � kelly schrank research digital enhancements for primary medical manuscripts: a survey on perceptions, challenges, and needs of medical publication professionals � patricia fonseca social media social media for the health care organization: sharing for good � diane lang and abbie roth freelance focus brian bass, allie boman, katherine molnar-kimber, and monica nicosia what are the pros and cons of using reference management software programs to manage references? what are your preferences in terms of software? is there a particular software that you would recommend to keep track of business expenses for tax purposes? calendar of meetings in the service of good writing counting and measuring � laurie endicott thomas contents editor-in-chief michael g. baker, phd managing editor jennifer workman section editors practical matters qing zhou, phd, els regulatory insights jennifer bridgers, ms, mwc science series paul c. dolber, phd social media jennifer minarcik, ms statistically speaking thomas m. schindler, phd everyday ethics julie ravo, ba, ma members matters govindi (jaya) samaranayake, phd freelance focus ruwaida vakil, msc regular contributors freelance focus brian bass, mwc melissa l. bogen, els sherri bowen, ma, els lori de milto, mj cathryn d. evans gail v. flores, phd phyllis minick in the service of good writing laurie endicott thomas, ma, els editor at large haifa kassis, md editors in memoriam lori l. alexander, mtpw, els, mwc ronald j. sanchez 2020–2021 president gail v. flores, phd 2020–2021 board liaison r. michelle sauer gehring, phd, els 2020–2021 staff liaison shari rager, ms, cae executive director susan krug, ms, cae graphic designer amy boches, biographics editorial office: managingeditor@amwa.org. instructions for authors available at: www.amwa.org/journal. advertising: contact marketing@amwa.org or (240) 239-0940. all advertising is subject to acceptance by amwa and should be for products and services relevant to professional medical communicators. amwa is not responsible for the content of advertising and does not endorse any advertiser or its products or services. subscription: the amwa journal is published quarterly. subscription is included with amwa membership. nonmember subscriptions cost is $75 per year. contact: american medical writers association, 30 west gude drive, #525, rockville, md 20850-4347. phone: (240) 238-0940; fax: (301) 294-9006; email: amwa@amwa.org. the amwa journal is in the mla international bibliography and selectively indexed in the cumulative index to nursing and allied health literature (cinahl) print index and the cinahl database. the opinions expressed by authors contributing to the journal do not necessarily reflect the opinions of amwa or the institutions with which the authors are affiliated. the association accepts no responsibility for the opinions expressed by contributors to the journal. ©2021 american medical writers association. all rights reserved, worldwide. issn 1075-6361 amwa journal mission statement in support of the mission of the american medical writers association (amwa) and to advance the broader profession, the amwa journal publishes content that reflects the interests, concerns, and expertise of medical communicators. its purpose is to inform, inspire, and motivate medical communicators. m o r e v36 n3 / 2021 127 amwa news from the president � gail v. flores 2021 president's award recipient: dikran toroser, phd, cmpp � gail v. flores the golden apple award: aaron bernstein, phd � elise eller slate of officer candidates for the 2021-2022 election � katrina r. burton amwa fellowships � elise eller find inspiration and gain fresh insights at amwa’s 2021 medical writing & communication conference 106 amwa journal / v36 n3 / 2021 / amwa.org abstract clients and employers are asking for infographics and visually appealing slides because they see infographics everywhere, and slides at conferences and meetings are looking different than in years past. they want graphical elements, short phrases, connections between ideas to be made clear, and to get to the point right away. putting together these new deliverables means incorporating a few key elements and thinking differently about how you present data. the elements needed are visual (color coding, graphics, and icons), content (timeframes and timelines, statistics, and references), and knowledge (facts and deductions). infographics come in different sizes: they can be an image of any size or shape, 1 or 2-page 8.5 by 11 sizes, or rolling infographics that are a standard screen width but any length (meant to be scrolled on a website). when creating visually appealing slides, use templates, icons, colors, and images to bring visual interest; put words into boxes, smartart, circles, shapes, charts, and graphics; and pare down the words and showcase certain words (often numbers or shorter phrases) with color, size, or space. create infographics and visually appealing slides using sites or templates available from these sites and from powerpoint office 365 to make this process easier. getting comfortable with these new visual formats might take some time, research, and exposure, but it can be a worthwhile addition to your skillset. whether your clients or employers call them infographics, ask for data visualization, or just complain that there are too many words or bullets, you have to figure out how to provide your data in a more visually appealing manner to keep up with changing ways of communicating. sometimes client or employer complaints reflect a feeling that something is not right, but they do not know how to fix it. this may come out in many ways: how can we make this look nicer? would this look better in a chart? could we have an image here? even if they are not asking for it yet, it is coming. infographics are everywhere, slides at conferences have a different look than in years past, and journals are now asking for graphical abstracts. people do not have the patience or attention span to read long paragraphs. they want short phrases on slides, connections between ideas to be made clear, and to get to the point right away. the concepts behind infographics and visually appealing slides include elements of data visualization. charts and graphs are used to help people quickly see patterns in data, but sometimes photographs are used to make a slide catch the reader’s eye or to show the point of the content. this article will discuss the elements of infographics and visually appealing slides, how to create them using sites and the tools and templates in powerpoint, and where to look for inspiration when trying to make data and content more visually appealing. this article’s goal is to help those who do not have access to a graphic artist to design images, infographics, and more visually appealing slides. those with access to a graphic artist should count themselves lucky, as many teams do not have these resources. what is an infographic? there are many different types of infographics, but they tend to have some common characteristics. infographics can be broken down into 3 easily digestible ideas as presented in the figure: visual, content, and knowledge.2 the visual come up again and again: color coding, graphics, and reference icons. essential to any infographic is the content, which includes time frames and timelines, statistics, and references. and lastly are the facts and deductions that make up the kelly schrank, ma, els / freelance medical editor, bookworm editing services, canastota, ny infographics and visually appealing slides data visualization is the graphical representation of information and data. by using visual elements like charts, graphs, and maps, data visualization tools provide an accessible way to see and understand trends, outliers, and patterns in data.1 f e a t u r e amwa journal / v36 n3 / 2021 / amwa.org 107 • the first size is the smallest, and it can be any size or shape. infographic images are often used in slides or a document to provide visual interest or to make connections between ideas or data. • the second size is a normal 8.5 by 11 document, either 1 page or 2 page. these 1 or 2-page infographics are used for handouts or in place of a document on a website. • the last size is a rolling infographic, which can also be any size. rolling infographics often appear as long images on a website, where they can be scrolled through to get to the different sections. they can cover a lot of information, but they must be accessed via a website and must be shared with a link to the site. the resources list has links to examples of infographics in each of these sizes. what is a visually appealing slide? a visually appealing slide covers only one idea, and it does so in an interesting way. according to slide:ology,3 “effective slide design hinges on mastery of 3 things: arrangement, visual elements, and movement.” each of these 3 things has many elements within it. under arrangement, duarte lists contrast, flow, hierarchy, unity, proximity, and white space. she feels you must use each of these to tell the audience what has priority; the worst thing you can do is “put everything on one slide and assign them equal value.” under visual elements, she lists background, color, text, and images. she believes that each of these “determines how your slide elements will look” and that you must be consistent in their use. under movement, she lists timing, pace, distance, direction, and eye flow, but much of this discussion centered around animation, and it was discouraged unless you really know what you are doing. the goal is to keep the reader’s interest by having a variety of thematically associated and relevant slides tell a story in a cohesive and interesting way. as a medical communicator, you may not always have the luxury of telling a really exciting story—maybe it is data about a study—but you can at least make the slides change a bit from each other without being so different they seem thrown together. one of the most difficult parts of this is breaking away from our reliance on paragraphs, or paragraphs masquerading as bulleted lists, and learning to break data into more manageable/digestible chunks. if an idea needs a paragraph to be explained, it should be spoken, and it can be put into the notes to act as a script. in some cases, perhaps an important quote, a paragraph is fine, but again, it should not be the default. similarly, slides with the standard bulleted lists should not be the default for a whole deck; use bulleted lists or numbered steps when they fit the purpose of a particular slide and try to expand how you present data on other slides. many times, breaking data into more digestible chunks requires more slides so that the speaker or the slide is only discussing one idea on each slide. if your deck is already too long, maybe you are just trying to do too much in one deck. how do you create infographics and visually appealing slides? sites there are many sites that allow you to create infographics and visually appealing slides, as shown in the table. all you have to do is pick a design and type information into it. for some projects, the site’s design may fit your needs, with good colors, shapes, fonts, and the right spaces for the content you need to add. all of the sites listed have infographic designs. canva, piktochart, and visme also provide a variety of other graphic designs: slide sets, infographics, images, posts, and videos. infogram and venngage are more focused on the rolling infographic and are the most locked down with the free version of their services. neither of these sites allows you to export the infographics you create on their site with the free version, and all you have is the version on their website with their logo or watermark when using the free version. because most of your clients and employers will not want their infographics to be figure. elements of infographics.2 knowledge. in theory, you should be comfortable with the content and knowledge part of this perspective. you are probably just struggling with putting them into a new visual format, and this article will discuss this in more detail. infographics come in different sizes based on their use: 108 amwa journal / v36 n3 / 2021 / amwa.org branded/watermarked or published to the public site of one of these companies, you would have to upgrade to a paid version to be able to use it with clients and employers. prices in the table reflect individual accounts (at time of publication), but upgrading to a corporate account would have the added benefit of sharing what you create with your team to allow collaboration. templates and tools in powerpoint templates for those with the office 365 version of powerpoint and some skills (or those who are willing to learn), you can use powerpoint and some of the infographic templates available to create different types of infographics. current versions of powerpoint for pc and mac have native templates for infographics. some of these available files will be whole slide decks with infographic-like elements, others have an infographic element like a timeline or a chart, others have images (called icons in this article), and many are the type of 1-page or 2-page infographics discussed earlier (some are called posters and others are just named with the topic). some have text that coincides with the topic; others have placeholder text (lorem ipsem). the added benefit of using powerpoint is the ability to share files with coworkers and collaborate in a tool ubiquitous in modern offices. you can also download powerpoint infographic templates from different companies; here’s a list of free infographic templates: https://graphicmama.com/blog/infographicpowerpoint-templates. whether using the infographic templates provided within powerpoint or from an outside provider, you can change colors, fonts, images, sizes, or anything else like any other powerpoint file. tools powerpoint in office 365 has many more options than older versions: the new design ideas function, more options in smart art, many more icons, and many more stock images. if you have an older version of powerpoint, you will still have templates and smartart, but you may not have the same icons, any stock images, or the design ideas function. if the stock images in powerpoint are limited in your version or just do not have what you need, you can also find free stock images from websites such as noun project (https:// thenounproject.com/), pexels (https://www.pexels.com/), pixabay (https://pixabay.com/), and unsplash (https:// unsplash.com/). remember to always use them according to the site’s terms and conditions and to give attribution whenever possible. where do you get inspiration? where can you get design ideas, see what is in fashion (yes, it is constantly evolving), and see what good design looks like? check out sites like canva (https://www.canva.com/), piktochart (https://piktochart.com/), and visme (https:// www.visme.co/), which all offer infographic and slide deck templates. explore the powerpoint options, especially the design ideas function, templates, and other tools available. check out organizations like the presentation guild, which offers a certification for presentation specialists, and the presentation summit, which offers sessions and workshops from industry experts in presentation design. infographics and visually appealing slides are not going away anytime soon, so it is good to get familiar with the elements of infographics and how you use them. when creating or updating slides, incorporating elements of infographics will make you stand out. table. sites for creating infographics and visually appealing slides free option site types of materials able to export? public publication? watermark/ branding? paid option (individual) canva infographics, slides yes no no ~$10/mo infogram infographics no yes yes ~$19/mo piktochart infographics, slides yes yes yes ~$29/mo venngage infographics no yes yes ~$49/mo visme infographics, slides yes yes yes ~$39/mo amwa journal / v36 n3 / 2021 / amwa.org 109 author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: kelly@headbookworm.com references 1. understanding data visualization techniques. great learning website. published 2020. accessed february 28, 2021. https://www. mygreatlearning.com/blog/understanding-data-visualizationtechniques/ 2. roy s. the anatomy of an infographic: 5 steps to create a powerful visual. spyrestudios website. published 2009. accessed february 28, 2021. https://spyrestudios.com/the-anatomy-of-an-infographic-5steps-to-create-a-powerful-visual/ 3. duarte n. slide:ology: the art and science of creating great presentations. o’reilly media; 2008. resources • for information on how to create infographics and visually appealing slides using powerpoint, see the how-to handout . • for an example of a handout infographic that discusses the common elements in infographics and visually appealing slides, see the handout infographic. • for an example of a rolling infographic that provides resources, such as sites and stock images, see the rolling infographic. • for an example of an image infographic that shows the three elements of infographics, see the image infographic. www.amwa.org/mwc three little letters. one big deal. apply now apply by october 18 for december 2021 exam. review our applicant handbook, candidate guide, and study tips to help you prepare. mailto:kelly@headbookworm.com https://www.mygreatlearning.com/blog/understanding-data-visualization-techniques/ https://spyrestudios.com/the-anatomy-of-an-infographic-5-steps-to-create-a-powerful-visual/ https://spyrestudios.com/the-anatomy-of-an-infographic-5-steps-to-create-a-powerful-visual/ http://www.amwa.org/mwc https://www.amwa.org/resource/resmgr/resource_library/visual_comm/handout_infographics_visuall.pdf https://www.amwa.org/resource/resmgr/resource_library/visual_comm/infographic_common_elements.pdf https://www.amwa.org/resource/resmgr/resource_library/visual_comm/rolling_infographic_example.png https://www.amwa.org/resource/resmgr/resource_library/visual_comm/elements_of_infographics.png https://www.amwa.org/page/mwc_apply amwa journal / v36 n4 / 2021 / amwa.org 159 abstract an impactful pharmaceutical promotional piece is an amalgam of a relatable narrative and agreeable visuals, a result of a highly synergistic relationship among medical writers, art directors, and designers. when it comes to innovation and creativity, a collaborative relationship will increase the likelihood of producing a piece that will touch the lives of the audience in a memorable way. although the audience of pharmaceutical promotion can comprise health care providers and patients, this article will focus on the latter. a few aspects of this partnership have been shown to increase the chances of achieving that goal, such as respectful communication, alignment on the brief, mutual encouragement, and use of lay language during discussions and brainstorming sessions. although nurturing storytelling, a strong skill of creative teams, is critical for the success of promotional medical pieces, ensuring scientific accuracy and avoiding misbranding are also key for complying with the ethical paradigms of medical communication and the us food and drug administration regulations. therefore, fine-tuning the partnership between medical and creative teams translates into a collaboration that combines freedom of creation with regulatory and scientific guardrails, as well as a strong sense of respect for each other’s views and expertise. introduction over a year and a half have passed since the beginning of the covid-19 pandemic, and we all have experienced profound changes in the way we live and interact with one another. in the realm of promotional medical education, this reality also applies. with the cancellation of congresses and personal interactions being restricted to the virtual environment, the sector has elevated digital tools and channels, creating an appetite for more involvement of creative teams in medical communication.1,2 with that growth, we have also observed a massive migration of creative teams, such as art directors and designers, from consumer agencies, that is, companies focused on advertising products outside the realm of health care, to medical communication, bringing a fresh perspective into the sea of sameness of the industry. with this shift, the presence of creative teams in medical communication has increasingly become more conspicuous, creating new work dynamics for medical writers, whose scientific background tends to embrace a higher focus on pure science rather than creative elements, such as visuals and engagement tools. these new circumstances have pushed many of us, medical writers, to ask ourselves, “what is the best way to work with creative teams?”; “how can we explore the best of both worlds with such distinct trainings?”; and “how can we stir each other’s motivation to accomplish the most compelling piece for our client while also ensuring scientific accuracy?” creating a partnership a good pharmaceutical promotional piece is an amalgam of a relatable narrative and agreeable visuals, resulting from a highly synergistic relationship among medical writers, art directors, and designers. when it comes to innovation and creativity, a collaborative relationship will increase the likelihood of producing a piece that will touch the lives of health care providers (hcps), the audience, in a memorable way. in the late 1950s, bill bernbach, founder of ddb worldwide communications group, a globally renowned advertising agency, decided to integrate copywriters with art directors as a team. because the approach worked undeniably well, other agencies gradually followed the approach. nowadays, most advertising agency creative departments in the world comprise such cross-functional teams.3 by and large, medical communication agencies have also followed the approach of integrating writers, art directors, andrea caricilli blotta, phd / medical director, area 23, new york, ny effective communication between medical writers and creative teams: the secret condiment for a flavorsome sauce f e a t u r e 160 amwa journal / v36 n4 / 2021 / amwa.org and designers as the core team that will ideate and produce all pieces according to brand strategic imperatives and the client’s direction, which are ensured to be followed by the client service team. in some agencies, the creative team is under the umbrella of shared services, as exemplified by the editorial department, whereas in others, each account has its own creative steward. the latter resembles that closer relationship between art directors and copywriters proposed by bill bernbach, allowing medical writers and art directors to work together throughout the trajectory of a particular brand. regardless of the model adopted, a few condiments have proven to be indispensable for the flavorsome sauce that is a memorable medical communication piece. one of them is building a solid relationship between medical and creative teams. according to simon veksner, the author of the book how to make it as an advertising creative, “the basics are the same as any human interaction. you need to listen to each other, respect each other’s point of view, and not expect the other to be perfect. after all, you’re not.”3 however, some could argue that this fundamental of human interaction does not always come easily, especially because moments of intense creativity can drive people to submerge in their own experiences and emotions. other times, the source of disconnect may come from the very nature of the training of each department, which may bring to the surface mismatched creative repertoires when brainstorming narratives and visuals together. one approach to overcome these challenges is to turn the team’s attention to the client’s interests and the success of the brand. in this sense, although challenging each other may feel uncomfortable at times, emerging from these brainstorming sessions for a few moments to realign on client interests serves as a reminder to keep the conversation respectful and avoid deviations from the strategic imperatives of the brand. another key approach for a successful partnership between these departments is alignment on the creative brief, which is the document used to outline the strategy of a project. the brief contains the purpose of the project, audience, messaging, scope of work, timeline, and other key information that helps all members of the team to understand details about the piece that they will develop (box 1),4 and it is a document that can be altered in case objectives or the scope change. the problem proposed in the brief needs to be clear for both medical and creative teams prior to their initial conversations and brainstorming sessions.3 this is a critical step for medical communication agencies, given that most art directors do not have scientific training, as opposed to traditional teams in consumer agencies, in which both the copywriter and the art director tend to have similar backgrounds. having that in mind, a good approach to level set the team when discussing a brief is to present the problem or the unmet need of the project in layman’s terms. along these lines, it is reasonable for medical, creative, and client services teams to write the creative brief for each project together. joining brand strategy, which is also a reflection of a company strategy, with solid scientific evidence and translating the problem that the brief proposes to solve into approachable language can enhance innovation and lead to a much more productive relationship between medical and creative teams. the importance of avoiding misbranding creative teams from consumer agencies are known for nurturing powerful storytelling in pieces that face fewer guardrails than medical communication agencies do. although cultivating robust storytelling skills is critical for the success of promotional medical pieces, ensuring scientific accuracy and avoiding misbranding are also key for complying with the ethical paradigms of medical communication. principle 2 of the american medical writers association code of ethics states the following: “medical communicators should apply objectivity, scientific accuracy and rigor, and fair balance while conveying pertinent information in all media.”5 in addition, avoiding misbranding is critical for compliance with the us food and drug administration (fda) regulations. the office of prescription drug promotion (opdp) is a section of the fda, and it protects the public health by helping to ensure that prescription drug promotion is truthful, balanced, and accurately communicated. all pharmaceutical advertising and promotional labeling undergoes review by the opdp to ensure that the information in these promotional materials is not false or misleading.6 among the tasks performed by the opdp are providing written comments to pharmaceutical sponsors on proposed promotional materials to ensure clear and unambiguous communication of the laws and regulations relating to prescription drug promotion, reviewing complaints about alleged promotional violations, initiating compliance actions on promotional materials that are false or misleading, comparing the product labeling and promotional materials of various closely related products to ensure that the regulatory requirements are consisbox 1. key information covered by a creative brief 1. company requestor 2. project description 3. objective 4. audience 5. unmet need 6. desired response 7. project overview 8. creative approach 9. project scope 10. constraints and assumptions 11. timeline 12. success criteria 13. budget amwa journal / v36 n4 / 2021 / amwa.org 161 tently and equitably applied, traveling to major medical meetings and pharmaceutical conventions to monitor promotional exhibits and activities, and acting as a liaison between opdp and other divisions within the fda on promotional issues.6 prescription drug promotion should not be false or misleading. specifically, every promotional piece must have a balance between efficacy and risk information and reveal material facts about the product being promoted, including consequences that may result from the use of the drug. in this respect, when medical writers and creative teams work together to develop a promotional medical piece, they must make sure all claims are appropriately supported and all comparisons are derived from head-to-head studies. in addition, when crafting narratives, it is indispensable to account for fair balance throughout the piece. for example, if alluding to the overall response rate after the use of a medication, one needs to account for the depiction of safety data in the same section.6 given the importance of certifying that all promotional pieces comply with the fda guidelines, a promotional review committee comprising representatives from the pharmaceutical company’s medical, legal, and regulatory (mlr) departments is charged with ensuring materials are fair balanced and meet function-specific standards while achieving marketing’s goals. each representative in an mlr committee has specific responsibilities and characteristics (box 2).7 techniques for building optimal partnership once medical, creative, and account services (ie, the department responsible for ensuring that the client’s needs are met box 2. key the mlr promotional review committee medical representative: individual with an md, pharmd, phd or other advanced degree. responsible for critically evaluating material for scientific and medical validity and consistency with the fda-approved labeling. legal representative: attorney with a jd degree. responsible for advising on legal risk by broadly reviewing materials for compliance with federal and state laws and industry codes/guidances. areas of expertise include copyright and trademarks, fraud and abuse, and antikickback issues. regulatory representative: individual who generally has an advanced degree in the sciences or healthcare and acts as the representative during interactions with the fda or opdp. responsible for ensuring that the material complies with all applicable fda laws and regulations on drug promotion. as a rule of thumb, medical and creative teams should follow the classic recommendation for brainstorming sessions in their everyday interactions: never use the word no. accurately and on time) are aligned on the creative brief and all key aspects of the project to be developed, such as unmet needs and the chosen tactic, timeline, and supporting scientific data, have been identified, it is time to let the creativity flow. although creative teams are more familiar with the techniques that boost the production of ideas for narratives and visuals than are medical writers, medical teams have a critical role in shepherding brainstorming sessions to ensure both scientific accuracy and compliance with the fda guidance. this fine balance translates into a partnership that combines the freedom of creation with regulatory and scientific guardrails, and it requires a strong sense of respect for each other’s views and expertise. as a rule of thumb, medical and creative teams should follow the classic recommendation for brainstorming sessions in their everyday interactions: never use the word no. in brainstorming sessions, this recommendation is important to avoid ruling out any of the ideas—because this is an early stage in the development process, all ideas should be received positively. in addition, from a human point of view, the word no tends to cause unwillingness to participate and negative emotions overall. instead of using the word no, one can modulate their tone of voice to make it clear they are unconvinced.3 on this note, it is crucial to avoid long debates. instead of spending extensive minutes or hours trying to kill each other’s suggestions, it is preferable to use the time available to put forward new ideas. in addition, it is essential that medical and creative teams inspire each other on a daily basis. according to paul monnes, medical director at bgb group, a medical communication agency, “the best approach is partnership. medical brings deep knowledge of the data, creative crafts evocative expressions of that data. when medical and creative colleagues can inspire each other, you develop strong work” (instant message, september, 2021). another key recommendation is to never show any disagreement in meetings with the broader team (ie, account, project management, editorial, and strategy). both the medical and creative teams need to establish internal alignment prior to sharing their proposals with other departments to avoid flattening their credibility with the team. when creating an inno162 amwa journal / v36 n4 / 2021 / amwa.org vative piece, medical and creative teams should weave into each other and become a fort with a grounded understanding of the brand. there are several approaches to optimizing a partnership between medical and creative teams during brainstorming sessions (box 3).3 the importance of emotion in medical communication hcps, the audience for hcp-focused branded and unbranded promotional pieces, have been overwhelmed with content and messages from an increasing number of stakeholders through numerous channels, an unparalleled reality that demands unprecedented outputs. according to chris bartley, deputy managing director at the medical communication agency havas life medicom, “cutting through the noise starts with developing a ‘big idea’ and requires clarity, originality, consistency and stand-out design in its execution. the fundamentals of creativity have never been so important. a great creative delivers an instant understanding of the problem and the solution on both an emotional and rational level. it’s difficult to describe, but when you see it, you know—it’s got that wow factor.”8 when touching upon medical content, it seems natural to distance ourselves from emotions, just like most physicians do. physicians, on one hand, are taught to remain detached from participating in any depth of emotions to maintain the objectivity considered crucial to accurate clinical decision-making. on the other hand, emotions are already highly present in the patient–physician relationship. according to the author of the book from detached concern to empathy: humanizing medical practice, jodi halpern, emotions should be recognized and used constructively in the service of empathy. in fact, in halpern’s view, critical clinical decision-making and diagnosis depend not on emotional distance but on emotional engagement that allows the physician to gain a deeper understanding of, and insight into, the patient’s experience of illness.9 along these lines, emotional connection can be used as an approach to innovate in promotional medical education pieces. creating room for emotions that we all yearn to express provides a sense of identity and genuineness. in addition, emotions create a bridge for hcps to connect with their patients on a human level. although creating an emotional connection between a promotional medical piece and its audience can be perceived with skepticism by some, it is a powerful storytelling resource that should be explored whenever applicable and executed according to the fda regulations. tapping into emotions not only creates a memorable learning experience but also provides a chance to relate to the patients treated by the audience of these promotional pieces. numerous approaches can be deployed when aiming for innovation, and it is true that technology can help create a highly engaging piece that will catch the eye of the audience. however, that does not necessarily equate to a memorable experience. for example, a conference booth employing an interactive game to engage visitors can create an enjoyable experience, a pause from long and tedious presentations. however, if it does not also create an emotional connection, the audience will likely turn its back once the activity is over and soon forget the core messages, if not the product altogether. these observations highlight the importance of creating a strong partnership between medical and creative teams—after all, exploring genuine and relatable emotions within every medical piece requires complete alignment and enthusiasm for working together as a team. anything less than a solid alliance will likely not tap into real emotions and therefore will not result in a memorable and innovative piece. conclusion the evolving landscape of medical communication with the incoming creative teams from consumer agencies has created a new opportunity for medical writers to explore new approaches to storytelling and visual engagement. thus, building a synergistic relationship between medical and creative departments is imperative to bring differentiation and excellence to our industry. acknowledgment thank you to ivan blotta, paul monnes, brett bauchner, nicole luciano, diala habib, david white, shirin mesbah oskui, ian box 3. discussion techniques to optimize partnership between medical and creative teams what you want to say how to say it acceptable, but we can do better. good. following strategic imperatives, but not very interesting. yes, that works (neutral tone of voice). i see something interesting, but it does not work. good—let’s develop this idea a bit more. off-brief and not interesting at all. i see (neutral tone of voice). terribly off-brief. can you say that one more time? very boring idea. ok. terribly off-brief, boring, and uninspiring. how about a coffee break? adapted from veksner s. how to make it as an advertising creative. laurence king publishing ltd; 2010. amwa journal / v36 n4 / 2021 / amwa.org 163 lafond, adam lach-szyrma, and javier inductivo for inspiring conversations about creativity in medical communication and to haifa kassis for feedback and recommendations to improve this piece. author declaration and disclosures: the views and opinions expressed herein are those of the author and do not necessarily reflect the views of area 23, its affiliates, or its employees. the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: caricilli@gmail.com references 1. lipworth k, cuozzo s, jones b. how medcomms has risen to the covid-19 challenge. the difference collective website. published june 10, 2020. accessed september 8, 2021. https:// thedifferencecollective.com/medcomms-rises-to-the-covid-19challenge/ 2. graham m. how a stay-at-home year accelerated three trends in the advertising industry. cnbc website. published march 13, 2021. accessed september 8, 2021. https://www.cnbc.com/2021/03/13/ how-covid-19-changed-the-advertising-industry-.html 3. veksner s. how to make it as an advertising creative. london: laurence king publishing ltd; 2010. 4. how to create a good advertising brief. digital school of marketing website. published december 10, 2019. accessed september 9, 2021. https://digitalschoolofmarketing.co.za/blog/how-to-develop-agood-advertising-brief/ 5. amwa code of ethics. american medical writers association website. updated june 2008. accessed september 12, 2021. https:// www.amwa.org/general/custom.asp?page=code_of_ethics 6. the office of prescription drug promotion. us food and drug administration website. updated july 1, 2021. accessed september 11, 2021. https://www.fda.gov/about-fda/center-drug-evaluationand-research-cder/office-prescription-drug-promotion-opdp 7. dankiewicz e. time to review your promotional review? best practices in the us. dia website. accessed september 12, 2021. https://globalforum.diaglobal.org/issue/april-2021/time-to-reviewyour-promotional-review/ 8. ross c. creativity in health communications. pmgroup website. published december 10, 2014. accessed september 1, 2021. http://www.pmlive.com/pharma_news/creativity_in_health_ communications_617873 9. angoff nr. making a place for emotions in medicine. yale j health policy law ethics. 2002;2(2):8. https://digitalcommons.law.yale.edu/ yjhple/vol2/iss2/8 alliance for continuing education in the health professions january 12-15, 2022 aurora, colorado https://www.acehp.org/annual-conference european meeting of ismpp january 25-26, 2022 london, uk https://www.ismpp.org/european-meeting american association for the advancement of science february 17-20, 2022 philadelphia, pennsylvania, and virtual https://meetings.aaas.org/ apha annual meeting & exposition march 18-21, 2022 san antonio, tx https://aphameeting.pharmacist.com dia europe 2022 march 29-31, 2022 brussels, belgium, and virtual https://www.diaglobal.org/en/flagship/dia-europe-2022 aces annual national conference march 31 – april 2, 2022 san antonio, tx https://aceseditors.org/conference/ annual meeting of ismpp may 9-11, 2022 washington, dc https://www.ismpp.org/annual-meeting stc technical communication summit may 15-18, 2022 virtual https://summit.stc.org dia 2022 global annual meeting june 19-23, 2022 chicago, il https://www.diaglobal.org/flagship/dia-2022 calendar of meetings please confirm with individual meeting hosts https://www.acehp.org/annual-conference https://digitalcommons.law.yale.edu/yjhple/vol2/iss2/8 mailto:caricilli@gmail.com https://thedifferencecollective.com/medcomms-rises-to-the-covid-19-challenge/ https://thedifferencecollective.com/medcomms-rises-to-the-covid-19-challenge/ https://thedifferencecollective.com/medcomms-rises-to-the-covid-19-challenge/ https://www.cnbc.com/2021/03/13/how-covid-19-changed-the-advertising-industry-.html https://digitalschoolofmarketing.co.za/blog/how-to-develop-a-good-advertising-brief/ https://digitalschoolofmarketing.co.za/blog/how-to-develop-a-good-advertising-brief/ https://digitalschoolofmarketing.co.za/blog/how-to-develop-a-good-advertising-brief/ https://www.amwa.org/general/custom.asp?page=code_of_ethics https://www.amwa.org/general/custom.asp?page=code_of_ethics https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp https://globalforum.diaglobal.org/issue/april-2021/time-to-review-your-promotional-review/ https://globalforum.diaglobal.org/issue/april-2021/time-to-review-your-promotional-review/ https://globalforum.diaglobal.org/issue/april-2021/time-to-review-your-promotional-review/ http://www.pmlive.com/pharma_news/creativity_in_health_communications_617873 https://www.ismpp.org/european-meeting https://meetings.aaas.org/ https://aphameeting.pharmacist.com https://www.diaglobal.org/en/flagship/dia-europe-2022 https://aceseditors.org/conference/ https://www.ismpp.org/annual-meeting https://summit.stc.org https://www.diaglobal.org/flagship/dia-2022 amwa journal / v36 n4 / 2021 / amwa.org 169 although it may seem like an unsolvable mystery and the constant changes are maddening, linkedin is a great way to find clients or a job and to build a strong network. this article highlights recent changes that medical communicators should know about and the 3 steps to making linkedin a career-building tool: (1) develop a complete, relevant, compelling profile; (2) build a big, relevant network; and (3) be active. with 58 million companies on linkedin and 774 million members (as of september 2021),1 linkedin is a great way to find clients or a job and to build a strong network. every minute of the day, 3 people are hired through linkedin and 4 out of 5 people on linkedin are decision-makers for their businesses.2 that’s why medical communicators need to know how to use linkedin, even if it seems like an unsolvable mystery and the constant changes, like the recent new look, feel, and features, are maddening. to make linkedin a careerbuilding tool, you need to 1. develop a complete, relevant, compelling profile, 2. build a big, relevant network, and 3. be active. these 3 things help you rank higher when linkedin generates search results so more clients or employers will find you. also, you can strengthen your network and gain knowledge, advice, and support from colleagues. this article highlights how to make linkedin a career-building tool and the recent changes—some good and some not so good—that medical communicators need to know about. develop a complete, relevant, compelling profile profile completeness and relevant keywords in your headline are at the top of linkedin’s search algorithm criteria. a complete profile includes • the industry and location, • a profile photo, • the current position (under experience), • 2 past positions, • education, • at least 3 skills, and • at least 50 connections (not technically part of your profile, but this is part of linkedin’s criteria for a complete profile).3,4 write a clear, compelling headline with relevant keywords your headline is the most important part of your profile, followed by the about section. linkedin’s recent changes increased the number of characters you can use for both. • headline: from 120 to 220 characters • about: from 2,200 to 2,600 characters having more space for your headline and about section can be helpful, but you don’t need to use all of it. you only have 3 seconds to capture attention with your linkedin lori de milto, mj / freelancer medical writer, lori de milto writer for rent llc, sicklerville, nj social media how strong is your linkedin profile? • click on your profile. • scroll down to your dashboard (only you can see this). • move your cursor over your profile strength meter to see what you’ve already done. • follow linkedin prompts to complete your profile. how to make a career-building tool 170 amwa journal / v36 n4 / 2021 / amwa.org profile.5 headlines at or close to 220 characters are too crowded to create a good first impression (figure 1). in your headline, clearly say what you do and how you help your clients or employers. include relevant keywords, such as “freelancer,” or your job title. here is a simple headline formula: • for freelancers: freelancer medical writer [or editor, etc.] |helping x do y • for employees: [job title] | helping x do y use a professional, high-resolution head and shoulders shot, and if you create a custom banner, make sure it’s professional and clear. the opentowork photo frame around a headshot is a new feature that i think makes freelancers and job seekers look desperate. if you have a complete, relevant, compelling profile, clients or employers will find you through their searches. also, the use of the opentowork frame can lead to scams and spam.6 make your about section compelling and relevant once clients or employers click on your profile, keep their attention by making your about section compelling and relevant. the first 220 to 270 characters with spaces count most. that’s what shows before people must click “see more.” on mobile devices, about 102 to 167 characters show. make sure the first 220 to 270 characters build on your headline and offer a clear, clientor employer-focused message. attract clients viewing your profile on a smart phone or tablet by putting as much of your key message as possible in the first 102 to 167 characters. in the rest of the about section, include just enough content to show clients and employers that you’re a good choice for them. briefly summarize your relevant experience, including services if you’re a freelancer, and your background. make sure your profile is public. your linkedin profile isn’t a resume • be interesting and conversational. • write short sentences and short paragraphs. • use bulleted lists for anything else that works well in a list. • include a call to action (eg, contact me to [benefit to client or employer]) at the end, and include your contact information again. the new featured section is very useful for medical communicators (figure 2). the featured section lets you display your best work to anyone who looks at your profile. it’s prime linkedin real estate: below the about section and above the activity section. you can include many types of content in the featured section, such as • media files, such as documents, presentations, and videos; • links to external blogs or work samples; and • your website (for freelancers) or your resume (for employees). if you had any media in your about section before, linkedin moved it to the featured section. check your featured section and customize it to highlight your best work. if you didn’t have media before, it’s easy to add a featured section. if you have at least 2 pieces of relevant (to clients or employers) content, you should have a featured section. it’s easy to add, delete, and move content in the featured section. build a big, relevant network even if you have a complete, relevant, compelling profile, you won’t show up in search results unless the searcher is connected to you. linkedin has 3 types of connections: • first-degree connections: your direct connections social media figure 1. a clear, concise headline vs a too-long headline. figure 2. sample featured section: lori de milto. amwa journal / v36 n4 / 2021 / amwa.org 171 • second-degree connections: people who are connected to your first-degree connections • third-degree connections: people who are connected to your second-degree connections the closer the searcher is to you (firstor second-degree vs third-degree connection), the more likely you’ll show up in search results. having at least 500 first-degree connections gives you a powerful network. say that you’re connected to 500 relevant people, other medical communicators and people doing related work. if each of your connections has 500 connections, you now have access to 250,000 people, many of whom are also medical communicators. it looks good on your profile when you have at least 500 first-degree connections because after 500, linkedin just notes “500+ connections.” it’s easy to build a relevant network of 500+. invite • colleagues from professional associations, • people you’re working with now (colleagues, clients, and employers), • people you’ve worked with in the past, and • friends and colleagues from school. you can also build your network through your linkedin activity. when you invite someone to connect with you, always add a personal note. mention what you have in common or why you want to connect. for example, “hi lori. i see that we’re both members of amwa. please join my linkedin network.” accept connection requests from people you don’t know as long as they are also medical communicators or are relevant to you in another way. don’t accept connection requests from people you don’t know who aren’t relevant to your career. be active being active means engaging with other people on their content and posting your own content. along with ranking higher in search results, being active helps you build relationships that can lead to referrals for freelance work or jobs. you can strengthen relationships with people you know and build relationships with people you meet on linkedin. once you learn what to do, being active doesn’t take much time or effort. review your linkedin feed—the content that shows up when you click on your linkedin home page—about twice a day. look for relevant posts by relevant people. linkedin offers 4 ways to respond: like, comment, share, or send. liking is lazy and won’t help you build relationships with people. responding under “like” with an emoji is a new feature. the only time i think this is acceptable is if you’ve already made a meaningful comment, the person who posted the content has responded, and you just need to acknowledge that response. but be careful which emoji you use; the 2 emojis with a heart aren’t professional, and the emoji of a face is questionable. commenting is the gold standard on linkedin. each comment is a way to boost your career because your name and the beginning of your headline are visible along with your comment. also, commenting allows you to actively engage with the person who wrote the post and with other people who comment on the post. write a meaningful comment. for example, if the post highlights an article with 10 tips for being productive, comment on which tip you want to try or what you’ve already learned from the article. make sure the person who wrote the post sees your comment by tagging them. to tag someone • type the @ symbol, • type the beginning of the person’s name, and • choose their name from the list that linkedin provides. if you comment on the post of someone you’re not connected to, that person is likely to accept a connection request from you, as are other people who comment on the same post. your invitation could be something such as, “hi lori. i really liked your post on xyz. please join my linkedin network.” or “hi lori. i see we both commented on lisa’s post on xyz. please join my linkedin network.” sharing means you can share the post with anyone, your connections, or groups. reshares get fewer views than other content and people are less likely to comment on a shared post than on an original post. sending, a new feature, lets you send posts to a specific person or people you choose. once you get comfortable commenting on other people’s posts about once or twice a week, do your own post. you can post about medical communication news and updates; useful free content like blog posts, podcasts, and webinars; and much more. include about 2 to 5 sentences about the content, with a link to the full content (news, blog post, etc). increase the number of views and engagement by using an image. if the full content has an image, linkedin will automatically use this image after you add the link. easily find content to post through amwa and other professional associations and email newsletters (eg, smart briefs). whether you’re engaging with other people on their content or posting your own content, always be professional social media 172 amwa journal / v36 n4 / 2021 / amwa.org on linkedin. ignore anything that is controversial or disrespectful. know linkedin’s limitations when used as described in this article, linkedin is a careerbuilding tool for medical communicators. like all social media, however, it is easy to waste time on linkedin. it is important to be strategic about building your network and your linkedin activity. also, certain features, such as stories, can be risky. linkedin says that the stories feature is like a virtual water cooler in an office. but in an office, you know the people you are talking to, and can say the right things to the right people. on linkedin, your connections and followers can see your stories, and they can share them with anyone. in addition, the stories are only visible for 24 hours. writing a relevant post is a much more efficient way to use linkedin to build your career than posting a story. make linkedin a career-building tool with the tips in this article and a little effort, you can more easily get clients or a job and build a strong network. just follow these 3 steps 1. develop a complete, relevant, compelling profile, 2. build a big, relevant network, and 3. be active. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: loriwriter@comcast.net references 1. linkedin’s economic graph. linkedin website. accessed september 27, 2021. https://economicgraph.linkedin.com 2. newberry c. 8 linkedin statistics marketers should know in 2021. hootsuite website. published january 12, 2021. accessed july 20, 2021. https://blog.hootsuite.com/linkedin-statistics-business 3. tanner n. all-star linkedin users are 40 times more likely to get contacted—here's how to score that rating. the muse website. accessed july 20, 2021. https://www.themuse.com/advice/allstarlinkedin-users-are-40-times-more-likely-to-get-contactedheres-how-toscore-that-rating 4. get noticed on linkedin—definitive guide. get five website. published april 21, 2021. accessed july 20, 2021. https://getfive.com/blog/ linkedin-profile-guide/ 5. dodaro m. how to create a magnetic linkedin profile: linkedin profile tips. youtube website. published may 28, 2020. accessed july 20, 2021. https://www.youtube.com/watch?v=yy1_dq3kgf8 6. guiseppi m. should you display #opentowork on your linkedin profile? executive career brand website. published november 10, 2020. accessed july 20, 2021. https://executivecareerbrand.com/should-you-displayopentowork-on-your-linkedin-profile/ social media dodaro m. massive linkedin changes in 2021: new features, tools and options. top dog social media website. accessed july 12, 2021. https:// topdogsocialmedia.com/linkedin-changes/ taylor t. how to write a professional linkedin headline (with examples). hubspot website. accessed july 12, 2021. https://blog.hubspot.com/sales/how-to-write-aneffective-linkedin-headline patel n. 10 tips for writing a winning linkedin headline. neil patel website. accessed july 12, 2021. https:// neilpatel.com/blog/linkedin-headlines/ morris v. how to use the linkedin featured section on your profile. social media examiner website. published april 15, 2020. accessed july 12, 2021. https://www. socialmediaexaminer.com/how-to-use-linkedinfeatured-section-on-your-profile/ your network and degrees of connection. linkedin website. accessed july 12, 2021. https://www.linkedin. com/help/linkedin/answer/110/your-network-anddegrees-of-connection?lang=en additional resources mailto:loriwriter@comcast.net https://economicgraph.linkedin.com https://blog.hootsuite.com/linkedin-statistics-business https://www.themuse.com/advice/allstar-linkedin-users-are-40-times-more-likely-to-get-contactedheres-how-to-score-that-rating https://www.themuse.com/advice/allstar-linkedin-users-are-40-times-more-likely-to-get-contactedheres-how-to-score-that-rating https://www.themuse.com/advice/allstar-linkedin-users-are-40-times-more-likely-to-get-contactedheres-how-to-score-that-rating https://www.themuse.com/advice/allstar-linkedin-users-are-40-times-more-likely-to-get-contactedheres-how-to-score-that-rating https://www.themuse.com/advice/allstar-linkedin-users-are-40-times-more-likely-to-get-contactedheres-how-to-score-that-rating https://getfive.com/blog/linkedin-profile-guide/ https://www.youtube.com/watch?v=yy1_dq3kgf8 https://executivecareerbrand.com/should-you-display-opentowork-on-your-linkedin-profile/ https://executivecareerbrand.com/should-you-display-opentowork-on-your-linkedin-profile/ https://executivecareerbrand.com/should-you-display-opentowork-on-your-linkedin-profile/ https://topdogsocialmedia.com/linkedin-changes/ https://topdogsocialmedia.com/linkedin-changes/ https://blog.hubspot.com/sales/how-to-write-an-effective-linkedin-headline https://blog.hubspot.com/sales/how-to-write-an-effective-linkedin-headline https://blog.hubspot.com/sales/how-to-write-an-effective-linkedin-headline https://neilpatel.com/blog/linkedin-headlines/ https://neilpatel.com/blog/linkedin-headlines/ https://www.socialmediaexaminer.com/how-to-use-linkedin-featured-section-on-your-profile/ https://www.linkedin.com/help/linkedin/answer/110/your-network-and-degrees-of-connection?lang=en v37 n3 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 3 michael g. baker, phd editor-in-chief from the editor amwa, like numerous organizations sensitive to the needs of its members, has embarked on an initiative to explore internal diversity, equity, and inclusion (dei). in this issue, we describe amwa’s commitment to dei through an initiative including the formation of a diversity & inclusion assessment task force. we also examine the makeup of our members via a summary of our most recent prior member survey in a piece titled “amwa: who we are.” a new survey of amwa members, the 2022 dei survey, has been distributed, and we encourage you to complete it soon if you haven’t already. results from this survey will be analyzed by the diversity & inclusion task force and thus will inform upcoming dei efforts. additionally, in this issue we have dei-related pieces on embracing accessibility and avoiding bias in accredited continuing education. in a future issue, we will return to the topic of dei to evaluate what we have learned and the enhancements to the organization that have come from amwa’s important initiative. yours in medical communication excellence, michael in november 2021, the amwa board of directors approved the creation of a diversity and inclusion (d&i) assessment task force. the charge of the task force is to analyze membership data and receive member input to help determine the current status of the organization’s d&i; identify deficiencies, needs, opportunities, and challenges related to d&i; and recommend initial strategies to enhance d&i efforts within the organization. the response to a call for volunteers in january and february of 2022 was positive, and several amwa members expressed their interest in serving on the task force. task force members were selected with consideration of their diverse perspectives, backgrounds, and experience with d&i initiatives. the task force first met virtually in march, and developed a diversity, equity, and inclusion (dei) survey that launched in august. the goal of the survey is for amwa to gain an understanding of who our members are and what our members need with respect to dei within the organization and in their professional lives. gail v. flores, phd / amwa diversity and inclusion assessment task force chair an update from the amwa diversity and inclusion assessment task force http://www.amwajournal.org amwa journal / v36 n3 / 2021 / amwa.org 133 find inspiration and gain fresh insights at amwa’s 2021 medical writing & communication conference stephanie wenick, mphil consultant, wenick communications, llc highlighted sessions: wfh! wtf? what i’ve learned from 32 years of working from home that might just help you survive brian bass, mwc / president, bass global, inc remote but not alone: navigating difficult personalities when you work from home melissa christianson, phd / whitsell innovations, inc with the boom in remote work, i am looking forward to hearing from seasoned work-from-home freelancers and professionals on how they have navigated the challenges of working from home. wfh! wtf? what i’ve learned from 32 years of working from home that might just help you survive and remote but not alone: navigating difficult personalities when you work from home promise to deliver effective strategies on how to work better when you are on your own and no longer steps away from team members. sarah dobney, mph senior manager, medical writing, sunovion highlighted session: bridging the gap: transitioning into regulatory medical writing savannah mageau, pharmd; shengjie xu, phd; and amber carr, phd / associate medical writers, merck as a regulatory writer for more than 20 years who now teaches at the graduate level, i am so looking forward to the bridging the gap: transitioning into regulatory medical writing session. i hope to gain insight into the nuances that it now takes to transition into the regulatory writing space in order to give my students the insight they request from me during class. i also look forward to being able to give my students information on how to leverage their previous experience and what they are learning to break into a career that i have loved from the beginning and hope they find success in! amwa’s 2021 medical writing & communication conference, which is taking place virtually from october 27 to october 29, will present 28 new education sessions on trends and opportunities for medical communicators. following a year that delivered disruption, ignited innovation, and required resilience in our professional and personal lives, the sessions accepted for #amwa2021 shine a spotlight on the importance of medical communication, and the strength and commitment of the medical writing community, during these difficult yet amazing times. we asked members of the amwa conference program planning committee to highlight sessions planned for the upcoming conference that have sparked their interest and to share a few thoughts about what they hope to learn. more on next page 134 amwa journal / v36 n3 / 2021 / amwa.org michele w. sequeira, ms, mba, mwc senior marketing representative, the university of new mexico comprehensive cancer center highlighted sessions: the quick and the dirty: best practices for writing and editing under tight timelines j. kelly byram, ms, mba, els1; theresa e. singleton, phd2; and damiana chiavolini, ms, phd3 / 1founder and ceo, duke city consulting, llc; 2singleton science, llc; 3southwestern medical center how plain language and readability strengthen writing crystal herron, phd, els / managing director, redwood ink i am looking forward to several educational sessions. the quick and the dirty: best practices for writing and editing under tight timelines describes my daily life. i love learning about new approaches to my work, and this session promises to give me a few pointers for keeping up quality when time is constrained, which is almost always the case. as someone who writes for general audiences and patients, i’m also looking forward to how plain language and readability strengthen writing. although i value plain language for its powerful ability to get a clear message to the target audience, i can’t always articulate why plain language improves the reading experience for even sophisticated audiences. i think that this session, with its data-proven tools, will improve not only my plain-language writing skills but also my ability to explain its importance to others. andrea giovannucci senior manager of education, amwa highlighted sessions: a systematic approach to manuscript editing kelly schrank, ma, els,1 and loretta bohn, els2 / 1freelance medical editor, bookworm editing services llc; 2senior editor/writer, rti international how to master scientific publications: a medical writer’s bag of tricks monica nicosia, phd / nicosia medical writer, llc i am excited to attend my first amwa conference and to experience firsthand the breadth and diversity of our educational offerings. as a former medical journal coordinator, i have seen the valuable impact that medical writers have on scientific publications, and i am looking forward to a systematic approach to manuscript editing and how to master scientific publications: a medical writer’s bag of tricks. ensuring that manuscripts adhere to reporting requirements, follow the proper guidelines, and yet are still accessible, is an incredible feat, and i look forward to the speakers sharing their tips and strategies these are just a few of the many education sessions available to conference attendees. all sessions will be recorded, which allows registrants to attend as many sessions as they want. the virtual conference platform will remain open to all attendees through the end of december. in addition to the plethora of education sessions, #amwa2021 will offer engaging roundtable discussions, inspiring award presentations, and a virtual exhibit hall filled with products and services designed specifically for medical communicators. the earlier you register the more you save and the more value you gain. register by september 30 to avoid the 11th-hour rates. we look forward to seeing you online! www.amwa.org/conference http://www.amwa.org/conference v37 n3 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 21 abstract this article provides a basic overview of the grammar of conditionals, the role of conditionality in predicate logic, and the difference between conditionality and causality. medical writers must achieve mastery of these concepts, which are important not just for clear writing but for rational thinking. english speakers use conditionals for many different purposes, such as describing facts, habits, and rules (zero order conditionals); describing the future consequences of realistic, possible, or likely events (first-order conditionals); expressing the likely consequence of some uncertain or impossible event (second-order conditionals); or talking about how things could have turned out differently if some condition had been met in the past (third-order conditionals). conditionals also allow one to ask questions about the consequences of an event or to express the conditions under which a command should be followed. conditional constructions are also sometimes used in expressions that don’t really express conditions (relevance conditionals). the grammatical differences between these expressions are subtle, involving the tense and mood of the verbs. conditionals allow you to talk about how the truth-values of different propositions are interrelated. thus, once you master the grammar of conditionals, you can begin to learn the rules and pitfalls of deductive and inductive reasoning. in science, such reasoning is often the first step toward proving causality. the existence of a tight correlation between two phenomena does not prove that one causes the other, but the lack of a correlation suggests that a causal relationship is unlikely. a conditional statement is a way to say that the truth of one statement depends on the truth of some other statement. a conditional statement contains 2 clauses: an if-clause (also known as the antecedent or protasis) and a main clause (also known as the consequent or apodosis). in the movie the wizard of oz, the cowardly lion sings, “if i were king of the forest…” he then describes what he and others would do. of course, because he is cowardly, he does not rule the forest, and nobody does any of those things. conditional statements can do something that seems like alchemy: they can combine 2 false statements and turn them into a truth. that’s because the truth of the conditional statement depends not on the truth value (truth or falsity) of either of its clauses but on the relationship between the truth values of the 2 clauses. in each conditional statement that the cowardly lion makes, both the if-clause and the main clause contain a statement that is false. yet, the conditional statement that he makes by putting those false statements together is true because if the antecedent were true, the consequent would also be true: if he did rule the forest, others would respect him. the grammatical rules for making conditional statements in english are simple, yet conditionality is a complicated subject that has been an active area of research in linguistics, philosophy, and cognitive science. as medical writers, we need to pay attention to 3 basic issues related to conditionality: • intelligibility—is the conditional statement grammatical and meaningful? • linguistic modality—does the antecedent contain a statement that is definitely true, possibly true, or utterly impossible? is the consequent a statement of fact, a suggestion of what might be possible, a command, a threat, or something else entirely? • the relationships between the statements—how tight is the relationship of the truth values of statements in the antecedent and consequent? does this relationship reflect some underlying cause-and-effect (causal) relationship? are these 2 statements not telling the whole story? as medical writers, we often need to express what is always true, what is generally or occasionally true, and what is true only under certain conditions. we must also grapple with questions of cause and effect and warn people about possible consequences. in english, we can use conditional laurie endicott thomas, ma, els / madison, nj if i were king of the forest…! — the grammar, meaning, and logic of conditional statements in the service of good writing http://www.amwajournal.org https://www.cdc.gov/media/releases/2018/p0816-disability.html https://www.w3.org/wai/fundamentals/accessibility-intro/ https://www.w3.org/wai/fundamentals/accessibility-intro/ https://webaim.org/articles/contrast/ https://webaim.org/articles/contrast/ https://www.afb.org/consulting/afb-accessibility-resources/afbs-social-media-accessibility-standards https://www.afb.org/consulting/afb-accessibility-resources/afbs-social-media-accessibility-standards https://adp.acb.org/ https://www.boia.org/blog/best-fonts-to-use-for-website-accessibility https://www.boia.org/blog/best-fonts-to-use-for-website-accessibility https://training.npr.org/2016/07/26/how-audio-stories-begin/ https://training.npr.org/2016/07/26/how-audio-stories-begin/ https://castos.com/podcast-script/ https://castos.com/podcast-script/ amwajournal.org 22the grammar, meaning, and logic of conditional statements statements to describe statistical and causal relationships, establish rules, make promises and threats, issue warnings, or even just express our feelings. yet all these different kinds of expressions have similar grammatical forms. unlike some languages, such as spanish, english does not use word endings to mark the conditional mood of verbs. nevertheless, there are grammatical rules that you need to follow when making conditional statements. this article explains the rules, as well as how conditional statements can be used to express all these relationships. structure of conditional statements all conditional statements include at least 2 clauses, one independent and the other dependent. a clause is a word string that contains a subject and a predicate. the consequent of a conditional sentence is an independent clause because it can stand on its own as a sentence. in contrast, the antecedent is a dependent clause (ie, it cannot stand on its own as a sentence) because it is introduced by a subordinating conjunction—usually “if” but sometimes other words, such as “when” or “unless”: if i were king of the forest…! this if-clause (antecedent) acts as an adverb that modifies the rest of the sentence. the antecedent expresses limiting conditions for the main clause of the sentence, whether that main clause is a statement or a command. the word antecedent comes from the latin for “to go before.” however, the antecedent of a conditional statement does not have to be at the beginning of the sentence. if the antecedent is at the beginning of a sentence, set it off with a comma; but don’t use a comma to set off an antecedent that follows the main clause. • if i were you, i would not do that. • i would not do that if i were you. sometimes, the subordinating conjunction “then” is used to mark the consequent of the conditional statement, but it is optional: if the light is green, [then] you can go. note that the clauses within a conditional statement can be compound (ie, they contain more than one independent clause): when it is warm outside and the sun is shining, i ride my bicycle and she goes swimming. types of conditional statements there are 5 basic kinds of conditional statements. each serves a different purpose (or set of purposes) and follows a different set of grammatical rules in english. zero-order conditionals a zero-order conditional is used to describe facts, habits, and rules. the verbs in the antecedent and consequent are often in the simple present tense. because the zero-order conditional expresses something that is always true, as long as the conditions are met, the timing does not matter and may go unspecified. in fact, the consequent may describe an event that happens before the event described in the antecedent, even though the word antecedent means “that which goes before” and consequent means “that which follows.” • if the solution is alkaline, the litmus paper turns blue. • whenever she leaves the house, she takes her cellphone. • if the patient is allergic to penicillin, a macrolide antibiotic is used. zero-order conditionals have been described as indicative conditionals (the indicative mood is used for expressing facts and truth). however, the clauses contained within the antecedent and consequent are not statements of fact. for example, the if-clause is not saying that there is a patient who is allergic to penicillin. also, if nobody has a penicillin allergy, then it’s possible that nobody will get the macrolide. thus, the verbs in the antecedent and consequent of an indicative conditional are not expressing a realis modality. as i explained in an earlier installment of this column,”1 realis modalities, such as the indicative mood in english, are used for expressing facts and truth. irrealis modalities are used for expressing other things, such as questions, commands, the antecedents and consequents of conditional statements, and statements that are contrary to fact. nevertheless, the conditional statement, taken as a whole, can be a statement of fact. a fact is not the same thing as a statement of fact; a fact is something that makes a statement of fact true or false. for example, if i state that there is a piano in my living room, the existence of the piano in my living room is the fact that makes my statement true. a conditional statement can be true if the facts support it. even though zero-order conditionals are called indicative conditionals, the consequent might not express something that is always true every single time the antecedent is true. it might instead express what is typically or often true. to clarify how tight the relationship between antecedent and consequent are, you can use adverbs such as “always,” http://www.amwajournal.org amwajournal.org 23the grammar, meaning, and logic of conditional statements “usually,” “generally,” “sometimes,” or “occasionally” in the consequent. if you call her during business hours, she usually answers. for zero-order conditionals, the words “when” and “whenever” can be substituted for “if.” she takes her cellphone whenever she leaves the house. the clauses in a conditional statement can also take a negative form: if the sun is not shining, the solar oven does not work. if the consequent is always true whenever the antecedent is true, the antecedent is considered a sufficient condition for the consequent: if patients with scurvy get vitamin c, they recover. of course, in medicine, the outcome of any case is going to depend on many factors, some of which go unstated and possibly unnoticed. as shakespeare’s hamlet put it, “there are more things in heaven and earth, horatio, than are dreamt of in your philosophy.”2 thus, it goes without saying that a patient who has had major bleeding from scurvy might need a blood transfusion, in addition to vitamin c. if, on the other hand, the antecedent must be true for the consequent to be true, then the antecedent is a necessary condition for the consequent. a necessary condition can be expressed by the inverse of the conditional, which negates both the antecedent and the consequent of the original conditional statement: if patients with scurvy don’t get vitamin c, they don’t recover. the inverse of a conditional statement can be phrased with “unless they do” instead of “if they do not”: unless they get vitamin c, patients with scurvy don’t recover. you can also use “only if” to express a necessary condition: patients with scurvy recover only if they get vitamin c. although a necessary condition must be present for the consequent to occur, the consequent might not occur even if the necessary condition is present. so, although it is generally true that people recover from scurvy if they get vitamin c, they might not recover if the vitamin c is given too late. if an antecedent is both necessary and sufficient for the consequent to be true, the statement is biconditional. a biconditional statement is true when its antecedent and consequent always have the same truth value (ie, both true or both false). biconditional statements can be phrased with “if and only if”: patients with scurvy recover if and only if they get vitamin c. first-order conditionals first-order conditional statements are used to describe the consequences of realistic, likely, or possible events. even though the if-clause generally refers to something that has not yet happened, its verb is in the present tense, whereas the consequent uses the future tense. first-order conditionals are often used in negotiations. if you finish the work early, i will give you a bonus. first-order conditionals can also be used to issue threats and warnings and to express superstitions. note that in those cases, the event described in the main clause might not happen, even if the condition in the if-clause is met: • if you hit me, i will hit you back. • if you don’t control your blood sugar, you will have serious complications. • if you break a mirror, you will have 7 years of bad luck. second-order conditionals second-order conditionals can be used to express hypothetical conditionals. hypothetical means founded on an idea that has not been verified as true. to emphasize the uncertainty or impossibility of the hypothetical antecedent, its verb is in the subjunctive mood, which follows the same conjugation as the indicative past tense in english. that’s why the verb sounds as if it is in the past tense, even when it is describing something that could happen in the future. a second-order conditional can be used to express a future event that would happen if some unlikely hypothetical event were to occur: • if i won the lottery, i would buy a fancy new car. • if i were to start training today, i would be ready to run a marathon by next summer. http://www.amwajournal.org amwajournal.org 24the grammar, meaning, and logic of conditional statements you can also phrase the second-order conditional without an “if,” but then you would have to switch the order of the subject and verb: were we to give up this fight, it would mean the end of democracy. a second-order conditional can also be used to express what would be happening now if things were different. these statements are counterfactual conditionals because the condition described in the antecedent is contrary to fact: if wishes were horses, then beggars would ride. third-order conditionals a third-order conditional is also counterfactual because it deals with conditions that were not met. it explains what would have happened in the past had the condition been met. the verb in the if-clause is in the past-perfect tense, and the verb in the main clause uses “would have” and the past participle. if i had known that you were coming, i would have baked you a cake. mixed conditionals there are 3 basic kinds of mixed conditionals. they all deal with counterfactual statements in the if-clause and the main clause. one deals with the consequences in the present if something different had happened in the past. the verb in the if-clause is in the past perfect, and the modal auxiliary “would” is used in the main clause: if julie had scored higher on her mcat, she would be in medical school today. another mixed conditional deals with what would happen in the future if something in the past had been different. the past perfect is used in the if-clause, and the auxiliary “would” is used along with some expression of the future. sometimes, “would be” and the present participle are used, or “would” and the bare infinitive, plus some adverb or adverbial phrase to indicate a future timeframe. • if she had booked the flight earlier, she would be going with us on wednesday. • if she hadn’t forgotten to book the flight, she would go with us on wednesday. another mixed conditional deals with a counterfactual if-clause in which the present tense is used to express a general fact or truth, and a main clause that talks about the past: if i were rich, i would have given you the money. other conditionals in a conditional question, the antecedent acts as a modifier to the question asked in the consequent: what do we do if the patient is allergic to penicillin? in a conditional imperative, the antecedent modifies a command that is given in the consequent: if you think that someone is having a stroke, call an ambulance immediately. there are also many statements that are phrased as conditionals, even though the truth value of the consequent has nothing to do with the truth value of the antecedent. these are sometimes called relevance conditionals or “biscuit conditionals”: • there are biscuits in the pantry, if you want some. (the biscuits are there, whether you want them or not.) • if you ask me, she’s out of her mind. the phrase “if only” can also be used idiomatically to express a wish: if only it would stop raining! the logic of conditionals when we study conditionals, we set foot on the bridge that connects grammar to logic. we have to think about how the truth values of the clauses within a conditional sentence relate to the truth value of the conditional sentence as a whole. we can then incorporate that conditional sentence into a logical argument, which may reveal other truths. conditional statement logicians often use capital letters, such as p and q, to stand for propositions. a proposition is a statement that can be true or false. the word proposition comes from the latin for “something put forth.” a proposition can be a supposition: something that you accept as true for the purposes of an argument. grammatically, a proposition has a subject and a predicate whose verb is in the indicative mood. logicians often use t and f to stand for “true” and “false” and a righthttp://www.amwajournal.org amwajournal.org 25the grammar, meaning, and logic of conditional statements ward-pointing arrow to indicate an if-then relationship. so, p→q means “if proposition p is true, then proposition q is true.” (note that the conditional statement p→q is also a proposition because it can be true or false.) the table shows the possible truth values of p and q, and the effect that these truth values would have on the truth of the various conditional statements involving p and q. note that p→q is false only when q is false while p is true. (this relationship holds when p→q is a hard rule that allows for no exceptions.) inverse statement logicians often use a tilde (~) to indicate negation. to form the inverse of a conditional statement, you negate both the antecedent and the consequent. • conditional: if i am king of the forest, i get respect. (p→q) • inverse: if i am not king of the forest, i don’t get respect. (~p→~q) note also that the negation of a negative statement is a positive statement: • negative statement: there are no cookies in the jar. • negation of negative statement: there are cookies in the jar. a conditional statement can be true while its inverse is false, and vice versa (ie, even a person who is not king of the forest can be respected) (table). contrapositive statement to form the contrapositive of a conditional statement, you negate both propositions and switch the positions of the antecedent and consequent. • conditional: if i am king of the forest, i get respect. (p→q) • contrapositive: if i do not get respect, then i am not king of the forest. (~q→~p) a conditional statement and its contrapositive are logically equivalent to each other (ie, they always have the same truth value) (table). thus, you can prove that a conditional statement is true by proving that its contrapositive is true, and vice versa. converse statements the converse of a conditional statement is made by switching the clauses. • conditional: if i am king of the forest, i get respect (p→q) • converse: if i get respect, i am king of the forest (q→p) a conditional and its converse do not always have the same truth value (table). lots of people who get respect are not king of the forest. the converse and the inverse of a conditional statement are logically equivalent to each other (ie, they always have the same truth value) (table). biconditional statements as described above, a biconditional statement is a way of saying that both a conditional (p→q) and its converse (q→p) have the same truth value (table). either they are both true, or they are both false. a biconditional statement can be expressed with a double arrow: p↔q. writers can express biconditionality by saying the conditional statement and adding “and conversely.” writers can also express biconditionality by saying “if and only if.” logicians sometimes abbreviate that to iff. valid and strong arguments logic is the study of how statements can be combined into arguments. for example, you could assert that both “if p, then q” and “p” are true. you can then use those propositions as premises to support the conclusion that q must therefore be true. the premises of an argument are if-statements, and the conclusion is a then-statement. the ∴ symbol is used as a conclusion marker. it can be translated as “therefore.” p→q p ∴q table. truth table antecedent consequent conditional inverse contrapositive converse biconditional p q p→q ~p→~q ~q→~p q→p q↔p t t t t t t t t f f t f t f f t t f t f f f f t t t t t →, if-then; ~, not, ↔, if and only if. http://www.amwajournal.org amwajournal.org 26the grammar, meaning, and logic of conditional statements in logic, an argument is valid if its conclusion must be true whenever all of its premises are true. if an argument is valid and its premises are all true, then it is sound. its conclusion will therefore be true. there are 2 important valid arguments that relate to conditionals: • modus ponens—if p→q is true, and p is true, then q is also true. “modus ponendo ponens” is latin for “the method of placing by placing.” • modus tollens—if p→q is true, but q is false, then p is also false. “modus tollendo tollens” is latin for “the method of removing by removing.” formal fallacies a logical fallacy is an error in reasoning that may lead you to draw a false conclusion, even if your premises are true. formal fallacies are logical fallacies that result from the improper form of the argument. informal fallacies can result from other problems, such as a misunderstanding of the meaning of the words involved. the following formal fallacies arise from a misunderstanding of how conditional statements work: • affirming the consequent—if you know that p→q is true, and q is true, but then conclude that p must therefore also be true, you have made an error called affirming the consequent (q being the consequent). this error is also called the converse error (q→p is the converse of p→q), or the confusion of necessity and sufficiency. you can see that p can be false even when p→q is true and q is true (table). • denying the antecedent—if you know that p→q, but that p is false, and you assume that q must therefore also be false, you are making an error called denying the antecedent (p being the antecedent). it is sometimes called the inverse error (~p→~q is the inverse of p→q). you can see that q can be true even when p→q is true, and p is false (table). inductive reasoning when we are dealing with the realm of pure thought, we often have premises that are unquestionably true. these typically involve mathematical truths and truths made necessary by the definitions of the words we use (eg, a bachelor is an unmarried male). as medical writers, however, we typically deal with premises that describe something in the physical world. thus, we use propositions whose truth values are less certain (eg, they contain adjectives such as “some” or adverbs such as “usually”). the arguments that we can base on those premises are less convincing. when we are using that kind of premise, the best we can do is to formulate arguments whose conclusion is unlikely to be false. the inductive probability of an argument is the likelihood that its conclusion will be true if all of its premises are true. • a deductive argument is one that is intended to provide a guarantee that its conclusion is true, provided that its premises are true. – a deductive argument whose conclusion is always true when all of its premises are true is valid (inductive probability, 100%). – an argument whose inductive probability is 100% and whose premises are all true is sound. – if there is even the slightest possibility that the conclusion can be false when all of the premises are true, the argument is invalid. – the conclusion of an argument can be true even if the argument is invalid and/or contains false premises. • an inductive argument is an argument intended to convince someone that the conclusion is unlikely to be false. thus, its inductive probability is <100%. – because their inductive probability is <100%, all inductive arguments are invalid. (the conclusion can be false even if all the premises are true.) – if the inductive probability is high, the argument is considered strong. – if the premises of a strong argument are all true, the argument is described as cogent. its conclusion is unlikely to be false. many people have seen lists of logical fallacies on the internet but don’t understand how to use that information. a fallacy is an error in reasoning. a deductive argument that contains a logical fallacy is invalid, which means that the conclusion can be false even if all the premises are true. however, the presence of fallacies or false premises in an argument does not mean that the conclusion is false. (if you reject a conclusion because you spotted a fallacy in the argument, you make an error called the fallacy fallacy.) similarly, the presence of a logical fallacy in an inductive argument does not mean that the conclusion is false. it simply means that the argument is invalid (but all inductive arguments are invalid). the real question is whether the fallacy seriously weakens the argument. consider the argument from authority. when you make an argument from authority, you cite expert opinion to support your argument. this argument is invalid because it is possible for the expert’s opinion to be wrong. but if the expert is reliable, then it is unlikely that the expert will be http://www.amwajournal.org amwajournal.org 27the grammar, meaning, and logic of conditional statements wrong. so, the expert’s opinion can add to the strength of an inductive argument. the conclusion of an inductive argument can be false even if the argument is strong and the premises are all true. that’s simply the nature of induction. however, an inductive argument can be so cogent (its argument so strong and its premises so undeniable) that doubt would be unreasonable. how cogent must an inductive argument be to be convincing? the answer to that question depends on the situation. what kind of decision are you going to make on the basis of that conclusion? is the decision reversible? what are the possible consequences of making the wrong choice? are those consequences minor or serious? are they reversible or irreversible? if the consequences are serious and/or irreversible, you might insist on hearing an argument with a high inductive probability. logical and causal relationships writers must think carefully about what a conditional statement implies, and what it does not imply. for example, consider the following statement: if you pick up a guinea pig by the tail, its eyes fall out. this statement is true, but not because of anything to do with the guinea pig’s eyes. the conditional statement is true only because guinea pigs never have tails. thus, the condition described in the if-clause can never be met. because p is always false, then p→q is always true. if a causal relationship exists, then you expect to find a high correlation between the cause and its effect. but even if you find that p and q are perfectly correlated (p is always true when q is true, and vice versa), it does not mean that p causes q. correlation does not equal causality. q might turn out to be the cause of p. or they could both be results of some other unknown cause. perhaps the correlation was simply a coincidence, a fluke—something that would disappear if you took a larger sample. nevertheless, a correlation is a reason to be suspicious. (the word suspect comes from the latin for “to look at secretly.”) so, if you see that something important is correlated to something else, you may want to look for an explanation. a correlation could be evidence that some cause is having an effect. on the other hand, if p and q do not seem to be correlated with each other, then a causal relationship seems less likely. implications for medical writers this article has provided a basic overview of the grammar of conditionals, the role of conditionality in predicate logic, and the difference between conditionality and causality. these are vital concepts for anyone who must think critically about any topic, including medicine. an understanding of the grammar of conditionals can help medical writers achieve better clarity in their writing. an understanding of the logic of conditional statements and the difference between conditionality and causality is essential for anyone who is writing about medical research. for example, you now know why expert opinion should be taken seriously (because experts are often right) but not too seriously (because experts are sometimes wrong). you also know why the materials and methods section of a study report is so important. it describes the conditions under which the study was conducted. if those conditions had been different, the results of the study might have been different. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: lthomas521@verizon.net references 1. thomas le. shoulda, woulda, coulda! amwa j. 2016;13(4): 184-185. 2. shakespeare w. hamlet. act 1, scene .5, lines 167-8. general principles of word usage www.amwa.org/online_learning choose the right word for accuracy and clarity. http://www.amwajournal.org amwa journal / v36 n2 / 2021 / amwa.org 79 introduction with over 1.2 billion users,1 microsoft word is arguably the most commonly used word processing and editing software throughout the world. medical writers use microsoft word daily for a variety of tasks, including manuscript preparation, proofing of patientfacing public health documents, medical presentations, and more. they are proficient with basic functionalities of word, but they may not be aware of more advanced features. here, we provide our best tips for producing better writing using microsoft word. these tips apply both to the current version of word included in microsoft office 365 and the standalone version currently available, called microsoft word 2019, which is part of microsoft office 2019. monisha’s tip: use advanced proofing features of microsoft word clear and impactful medical writing requires education and experience in medicine or health, writing skills and talent, attention to detail, and passion. microsoft word’s littleknown proofing features can be another key to producing great copy. microsoft word’s hidden proofing features take a bit of time to find, but they are well worth the effort. it was many years into my medical writing career that i learned about microsoft word’s advanced proofing features. that is because these features are “hidden” and are not enabled by default. did you know that microsoft word can alert you to jargon, simpler language, and passive voice? this microsoft word proofing review will make suggestions for you to accept or ignore. keep in mind the style guide for your target publication or for your target audience. for example, sometimes passive voice may be acceptable in medical and scientific writing; if the proofing review suggests you have used passive voice, consider whether it is appropriate and accept or reject microsoft word’s suggestion. i run a complete proofing check on all of my writing products. here is how to get started: monisha arya, md1; sheeva azma, ms2/ 1independent medical writer & editor, arya communications, houston, tx; 2independent science writer & editor, fancy comma, llc, oklahoma city, ok little-known tips for using microsoft word for clear writing practical matters monisha’s little-known tips to uncover hidden proofing features in microsoft word open a blank document in microsoft word. 1. go to file and select “options” at the very bottom of the menu. 2. under word options, select “proofing” (figure 1). 3. go the section entitled, “when correcting spelling and grammar in word.” 4. ensure that all boxes are checked. 5. for writing style, select the drop-down option for “grammar & refinements” (this may also be listed as “grammar & more”; in word 2010, it is listed as “grammar and style”). 6. click on “settings…” (here is where a lot of the proofing features live!) (figure 2 on next page). 2 3 4 5 6 figure 1. microsoft word’s proofing options. 80 amwa journal / v36 n2 / 2021 / amwa.org 7. there are over 100 (!) features listed! i select all of them. remember that the style guide of your target publication or audience can help guide which “suggested” changes you should accept after microsoft word performs the review. 8. click “ok” to save changes. 9. click “check document” (figure 3) to allow microsoft word to do a new review (this may also be listed as “recheck document.”). after clicking on “check document,” another dialog box may appear asking you if you wish to reset the microsoft word spelling and grammar checker and apply the new settings. you will need to click “yes” here. there is another way to get to the proofing features in microsoft word. you may also see the editor icon in the review panel of your version of microsoft word (figure 4). you can click on this button, and then click “settings.” then, follow the steps above starting at number 6. of course, the microsoft word proofing feature is not perfect, and will not find all elements that you could (or should) refine to make your writing clearer and impactful. the proofing feature also sometimes recommends changes that you should not make in the context of your document. i have found that the proofing feature still misses some grammar or syntax mistakes. using the feature is a start, and you may need to make additional refinements to add a human element to proofing. sheeva’s tip: use microsoft word’s “read aloud” feature i am always learning new things, even after using microsoft word and other office suite products for over 2 decades. recently, i learned that microsoft office 2019 has a “read aloud” function which will read your word file out loud. this can be useful in editing if you perhaps need to do a quick pass to catch errors in the text as it is being read aloud. with the read aloud function, you can sit back as microsoft reads through the document. our brains use different cognitive processes to read text from a page compared with listening to text being read out loud. a study out of the university of perugia in italy suggests that actively listening to text being read out loud may lead to more “intense and deeper information processing,” according to a report by the british broadcasting corporation.2 sheeva’s tip to reveal the read aloud feature in microsoft word the read aloud function of microsoft word 2019 can be found in the review tab (figure 5). when you click the read aloud button, a sidebar pops up with controls shown in figure 6. figure 2. microsoft word’s “grammar and refinements” menu bar contains all of the little-known proofing features of the popular software. 7 8 figure 3. once you select your desired proofing options, remember to click “check document” to apply them to your file. figure 4. clicking the “editor” button in the review tab of microsoft word’s menu bar is an easy way to access these littleknown proofing options. practical matters amwa journal / v36 n2 / 2021 / amwa.org 81 the settings icon allows you to select from different reading voices and change reading speed. if you are, like me, using the american english version of microsoft word, you can choose from several reading voices, including 2 male voices (microsoft david and microsoft mark) and a female voice (microsoft zira). microsoft word’s read aloud feature can be useful to quickly review a document for errors. when you catch an error, you can pause read aloud, make the changes, move your cursor back to where you want to start reading, and use the controls to restart read aloud. there are a couple of disadvantages to the read aloud function. one downside of the read aloud function is that, if you try to type or make edits to the document while it is being read, you risk accidentally deleting text as the cursor tracks the text being read. you must first exit or pause read aloud mode before making any changes to the document. another downside of using read aloud is that it does not work seamlessly with the track changes feature in word. when there are tracked changes in your document, the read aloud function simply reads the text that is on the page, whether it has been modified (deleted using track changes) or not. so, it is best to use a final copy of your text that does not have tracked changes in order to achieve the best results with read aloud. figure 5. the “review” tab contains the read aloud option in microsoft word. figure 6. microsoft word’s read aloud function button controls. from left to right, they are back, play/pause, forward, settings, and exit. learn more jump-start your career in regulatory writing. www.amwa.org/online_learning we hope that learning about these little-known tools will help you optimize your use of microsoft word and help you write more clearly. author declaration and disclosures: sheeva azma owns microsoft stock. the authors note no additional commercial associations that may pose a conflict of interest in relation to this article. author contact: aryacampaigns@gmail.com references 1. callaham j. there are now 1.2 billion office users and 60 million office 365 commercial customers. windows central website. published 2016. accessed january 1, 2021. https://www.windowscentral.com/thereare-now-12-billion-office-users-60-million-office-365-commercialcustomers 2. hardach s. why you should read this out loud. bbc website. published 2020. accessed january 1, 2021. https://www.bbc.com/future/ article/20200917-the-surprising-power-of-reading-aloud practical matters https://www.windowscentral.com/there-are-now-12-billion-office-users-60-million-office-365-commercial-customers https://www.bbc.com/future/article/20200917-the-surprising-power-of-reading-aloud http://www.amwa.org/online_learning v37 n2 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 36 maud mellish-wilson – librarian, editor, visionary biography tom lang / principal, tom lang communications and training international, kirkland, wa abstract maud mellish-wilson was an early and influential voice in biomedical communication. in the early 1900s, she was hired by mayo clinic to set up its first library, but she accomplished a great deal more. a competent editor, she established the clinic’s division of publications, which helped establish the clinic as a world-renowned health care and research center, and probably the craft of author’s editing as well. the division still supports authors during all stages of scientific publishing and remains a model for research centers around the world. she started the collected papers of mayo clinic, which summarized the articles published by clinic authors each year; wrote an important book on medical writing and editing; and began what would become mayo clinic proceedings. the mayo brothers considered her to be 1 of the founders of mayo clinic, along with their father. here, i describe her life and accomplishments to recognize her achievements and to contribute to the history of the profession of medical writing and editing. maud mellish-wilson was the first editor at mayo clinic (figure 1). she headed the division of publications from its creation in 1914 to 1926 and continued to edit for the clinic until she died in 1933.1 as an early and visible author’s editor, she is credited with greatly increasing the quality and consistency of manuscripts leaving the clinic. in her 26 years there, she set new standards for scientific publishing, wrote a book describing those standards, initiated and edited the first 24 volumes of the collected works of the mayo clinic, launched what would become mayo clinic proceedings, and became a legend both at the clinic and in the scientific community. her early years annie maud headline was born to swedish immigrants on february 14, 1862, the youngest of 7 children.1 the family lived in a log cabin near the small town of faribault on the plains of minnesota, 50 miles from rochester to the southeast and 50 miles from minneapolis to the north.1,2 the civil war had begun the year before, and in a few months, the short but bloody dakota war of 1862, which pitted settlers against the santee sioux indians, would begin not far from town. in her childhood, she was curious, strong-minded, and practical to the point that her parents often followed her advice.1,2 she wanted to be a doctor, but women were not generally allowed in medical school at that time, and money was scarce. instead, she went to nursing school in chicago, auditing lectures at rush medical school at the same time.1 at rush, her persistence and intelligence were noted by 2 prominent physicians, dr moses gunn, head of surgery at rush, and dr charles parkes, surgeon-in-chief at augustana hospital. she developed close and lasting friendships with both men.1,3 shortly after graduating from the illinois training school for nurses in 1887,4 she went to work at the 50-bed maurice porter memorial hospital for children, eventually becoming the superintendent of the hospital.2,4 in 1889, at age 27, maud married dr ernest j. mellish, a promising young surgeon teaching at rush medical school.1,5 ernest had contracted tuberculosis before they married, and his health problems were to last throughout the marriage. they moved to michigan, where ernest built a successful surgical practice with maud as his surgical assistant. during the marriage, she dropped her first name, annie, and went by maud.2 figure 1. maud mellish-wilson. date unknown. born annie maud headline, she dropped the name annie during her marriage to dr ernest mellish, who died in 1905. she kept his name when she remarried to dr louis wilson. (used with permission from mayo foundation for medical education and research.) http://www.amwajournal.org amwajournal.org 37maud mellish-wilson – librarian, editor, visionary in 1893, they moved back to chicago. despite a severely depressed economy, ernest found work at charity hospitals and returned to teaching at rush. during this time, maud began to edit his articles.2 ernest later wrote, “maud is of inestimable aid to me in revising my papers. i am sure they are much more readable for the revision. there are no superfluous words left in them.”1 ernest’s disease went into remission in 1897, and for 4 years, he was able to build his practice again. when the disease recurred in 1901, he and maud moved to el paso, texas, where they hoped the arid environment would be beneficial. he died of tuberculosis in 1905, cared for by maud until the end.1,2 after her husband’s death, maud returned to chicago and found work organizing the library at augustana hospital where she had friends.2,4 there, at age 43, she met dr albert ochsner, the chief surgeon at the hospital and an increasingly famous and prolific writer.2,6 (later, he would help found the american college of surgeons.6) he hired maud to edit his manuscripts, and her skill and intellect led them to become good friends and trusted colleagues.3 (dr albert ochsner mentored dr alton ochsner, a distant relative, who would establish the ochsner clinic in new orleans in 1942. in 1963, dr alton ochsner was made a fellow of amwa.7) mayo clinic was founded in 1889 as part of saint mary’s hospital and in cooperation with the franciscan sisters who ran it.8 the original medical staff consisted of dr william w. mayo and his 2 sons, william and charles (affectionately called “dr will” and “dr charlie” by everyone at the clinic).9 the 3 introduced the integrated, multidisciplinary approach to medical care now common throughout the world. the clinic grew rapidly in size and reputation—in 1904, the 2 brothers operated on more than 4,000 patients8—and was developing its medical specialties, laboratory facilities, educational programs, and other support services. dr will was looking for someone to organize and develop a library to “run the literary end of the business.”4,10 he asked his friend, dr albert ochsner, if he knew someone suitable for the job. dr ochsner immediately recommended maud.1,2 in early 1907, after maud had visited the clinic at the invitation of the brothers, dr will wrote to her, saying “we want you, we want you badly, and the sooner the better... we want you to develop a library and to do editorial work on scientific publications.”1,2,4 having recently lost her husband, not wanting to return to nursing, and feeling that it was too late to go to medical school at age 45, maud joined the clinic 3 months later.1,2,11 her years at mayo clinic when maud arrived at the clinic, the library consisted of “three small book cases, a few journals on a small reading table, and the books owned by various members of the staff.”1,12 she also reportedly found copies of dozens of publications by the mayo brothers and their father stored in a basement coal bin.1,2,11 she pulled the papers from the coal bin, cleaned and organized them, collected books and articles from around the clinic, ordered missing journal volumes, arranged for interlibrary loans, and, in general, created order out of chaos.1 she built the collection carefully to meet the specific needs of the clinic. after wwi, many european libraries were sold, and the clinic was able to add several rare and important books to fill gaps in its collection.1 she also visited medical libraries around the country to collect ideas for the design of a new library that opened in 1914.2 within a few years, she had increased the library holdings to more than 4,000 volumes.13 when she died in 1933, there were 40,000.1 dr louis b. wilson (1866-1943) was brought to the clinic to develop its laboratory services as chief of pathology, a position he held from 1905 to 1937.14 he met maud shortly after she began working at the clinic, when they were given the task of designing the new library for the 1914 expansion of the clinic. maud said of him, “i have met few men his intellectual equal. in addition to his scientific abilities, he has a most pleasing personality.”1 louis’s first wife died in 1920, and he and maud married in 1924.2,4 louis would become the first director of mayo foundation and was a national leader in graduate medical education in the 1920s and 1930s.15 the division of publications when maud became the clinic’s first professional editor,13 she had had close to 20 years of experience helping authors prepare manuscripts for publication which, in her view, “did not stop at checking grammar and punctuation.”13 (an understatement, to be sure.) when dr will noted that the quality of the articles written by clinic staff “was not up to the standard of their clinical work,”2 he asked maud to help authors improve their writing. soon, in addition to managing the library, she became head of the new editorial office and later, the head of the new division of publications in 1914.1,4,12 advances in printing had improved the reproducibility of photographs and medical illustrations and made them less expensive to publish. in time, 4 photographers (maud made a point of hiring women photographers) and 2 medical illustrators were added to the division.1,11,16 she designed a clinhttp://www.amwajournal.org amwajournal.org 38maud mellish-wilson – librarian, editor, visionary ic-wide system for registering, editing, submitting, revising, and tracking manuscripts through the publication process, a centralized service that continues today.12 according to one biographer, maud “set herself the task of seeing to it that the rochester men said what they meant to say, that they were accurate in their facts and, as far as she could ensure it, straight in their thinking.”1 one story goes that dr charlie left a paper for maud to edit while he was away for several weeks. he returned to find an article on his desk, read it, liked it, and wondered who had written it—until he realized it was his paper made better by maud’s editing.2,13 (dr charlie, as editor-in-chief of postgraduate medicine, received amwa’s 1958 honor award for distinguished contributions to the medical literature.7) in fact, between 1909 and her death in 1933, not a single manuscript left the clinic until it met her standards.13,14 she gave recalcitrant authors a choice: bring your paper up to standard or publish it under your own name, without the clinic’s support. or, as her future successor, dr richard hewitt, said, “the paper... either descended by slow degrees into desuetude [a state of disuse] or was elevated to the heavens and has a star named after it.”12 this policy paid off as journal editors noticed that every paper they received from the clinic was technically sound and unusually well prepared.1 there is little doubt that maud’s efforts greatly improved the clinic’s publications, which substantially advanced its reputation, as well as that of its staff at a critical period in the clinic’s history.13 (this reputation has persisted for more than 80 years. ed huth, then editor-in-chief of the annals of internal medicine, told me in the early 1990s that, “when you get a manuscript from mayo clinic, you just know it’s going to be tightly edited, formatted correctly, and a pleasure to read.” if ever there were an argument for insisting on rigorous editing and high standards, this is it.) the collected papers of mayo clinic in the early 1900s, physicians and hospitals generally did not advertise because such promotion was considered improper if not unethical. as a result, the mayo brothers kept a low profile—including turning down an interview with life magazine—to avoid the appearance of impropriety.2 however, they were aware that physicians built their reputations by publishing in scientific journals, which of course was why they hired maud. with maud, however, they got more than just a librarian and an editor: they got a visionary. in 1909, maud selected the most important papers written by clinic authors since 1905 (apparently including some rescued from that coal bin) and published them as the collected papers by the staff of st. mary’s hospital mayo clinic1 “to present adequately the work of the mayo clinic and the mayo foundation.”17 the volume was the first of a series that continued for decades as the collected papers of mayo clinic. the papers increased the clinic’s professional visibility in a way that individual articles could not. for example, volume 1 was 686 pages; volume 15, published in 1924, was 1,420 pages. of “629 papers published [in volume 46] between december 1, 1953, and november 30, 1954, 63 are republished in full, 52 by abridgement, 20 by abstract, and 495 by title.”17 maud edited and published at least 1 volume every year until her death in 1933. the volumes she edited represented more than 6,000 articles. the writing of medical papers in 1922, maud published the writing of medical papers (figure 2).18 although it was not the first book on the topic,1921 it appears to have been among the most popular, going through 3 editions in 1922, 1925, and 1929. the book itself is a grammar and usage guide, a style manual, a textbook on preparing scientific articles, a reference for journal abbreviations, a summary of proofreader’s marks, and an explanation of publication practices. of the 20 chapters, 7 are devoted to grammar and usage in medical publications (describing many conventions still followed today), and the last 13 concern preparing the scientific article and its parts, including the use of abbreviations, scientific style, and the importance of revising. in a summary at the end of each chapter, the topics were “reduced to a minimum, and rules have been made definite, even dogmatic, that they may be easy to refer to and follow” (box on next page).18 the text is strictly utilitarian, but maud’s humor often comes through. many sentences are statements about what authors should do when writing, such as “use standard abbreviations only,” “writers should not be too ready to figure 2. maud’s book, the writing of medical articles.18 the book appears to be one of the earliest and most popular guides for preparing medical articles. much of the content is still relevant. used with permission of mayo foundation for medical education and research. http://www.amwajournal.org amwajournal.org 39maud mellish-wilson – librarian, editor, visionary follow others in the misuse of terms or words,” and “do not submit a manuscript for publication until it has been made as perfect as possible.” chapter 7, titled simply “don’ts,” includes sound advice: • “don’t say case when you mean patient.” • “don’t say due to when you mean attributable to or on account of. due to is inaccurate and slovenly.” • “don’t begin as many as ninety-five percent of your sentences with thus.” • “when writing a medical paper, don’t always go back to the garden of eden and review the literature to date.” (elsewhere, she explains this advice: “the order of development of a subject is rarely the order in which it should be studied... review the more recent articles first.”)22 • “keep down your that’s, for they multiply like lower organisms.” • “do not invent words.” in the 3rd edition, she writes, “it would seem that an impression is abroad among the writers of academic essays that the first person is indecent.”23 her endorsement of using first-person pronouns in medical texts is consistent with the recommendation of george gould, an important early journal editor and one of the founders of what would become the american medical library association, who gives the same advice in suggestions to medical writers, published in 1900.19 her book may also have influenced george simons and morris fishbein, then the editors at the journal of the american medical association, in their book, the art and practice of medical writing.24 chapter 18, titled “the manuscript,” reads like the instructions for authors found today in every journal. she recommended a variation of the harvard (name-date) referencing system in which articles are alphabetized by the first author’s last name in the reference list, numbered sequentially, and then the numbers placed in the text, not the first author’s last name and date of publication as they are in the harvard system. mayo clinic proceedings as the clinic grew, not every staff member could attend all meetings. in 1919, maud and her division began to prepare short, daily summaries of the meetings in an in-house newsletter called the clinic bulletin.9,11 in 1926, the focus of the bulletin was narrowed to the topics covered in what appears to have been weekly grand rounds.9,11,25 the name was changed to the proceedings of the staff meetings of the mayo clinic in 1927 and to mayo clinic proceedings in 1964, when an editor-in-chief and an editorial board were appointed to make the proceedings a separate, monthly, peer-reviewed medical journal.9 her legacy today, the main library of the clinic stands where maud’s library stood. it now includes 400,000 volumes. in fact, the clinic runs 15 other libraries in 4 states and employs more than 30 professional librarians and 40 library associates. in 2021, the 5,300 physicians and researchers throughout the mayo clinic health system published 12,500 articles and case reports and an unknown number books, chapters, letters, comments, and other publications. (personal communication with leann stee, head, scientific publications, mayo clinic, 4 april 2022.) the collected papers went through 60 volumes before publication stopped in 1969. in 2019, the proceedings was sent without charge to 130,000 people around the world. in 2020, it ranked eleventh among 154 general internal medicine journals indexed in journal citation reports.26 quotes from the writing of medical papers by maud mellish-wilson18 “a good writer addresses persons who have to comprehend, to decide, and to act.” [this sentence is the very definition of technical writing.] “it is quite possible for the casual writer to be wholly inappreciative [sic] of the time and care expended by editors in recasting and checking tabulated data.” “don't fail to go over your pages diligently; relentlessly ‘thin out’ words. a good writer takes a hint from a good gardener.” “don't rise to poetic heights except when describing genuinely poetic subject matter.” “many writers pay little serious attention to their introductions... at no time is bewilderment more fatal for the reader than at the start... starting is as much more difficult than continuing for a reader as it is for a locomotive attached to a heavy train.” “don't estimate measurements [of tumors] in terms of cocoanuts, oranges, fists, eggs, beans, and so forth; use the metric system.” (gotta love that one.) “... few realize the amount of earnest effort and painstaking labor which a conscientious editor bestows upon many a paper to make it readable and worthwhile.” (well said!) http://www.amwajournal.org amwajournal.org 40maud mellish-wilson – librarian, editor, visionary when maud died in 1933, dr hewitt became head of the division of publications. in 1957, he became president of amwa.7 in 1964, the clinic created the department of biomedical communications. its first director was a prominent physician named dr charles roland, who became president of amwa in 1969.7 maud remembered maud was described as “a tall, handsome woman, regal in appearance and in manner”1 who had “the ability to do well a great deal in a short time.”12 “she was a severe critic, never minced words in expressing her opinion, and was inclined to be high-handed in correcting and revising.”1 (my favorite quote from her book is, “don’t think that [grammatical] atrocities are pardonable.”23) dr will said of her, “staff members, faculty, and fellowship men alike received much aid in the preparation of their written contributions. they were taught where and how to obtain references from the library, to be accurate and concise, with proper literary form, and, above all, to give credit to other workers, and not by half-truths to over-emphasize unimportant details, which might lead to misconstruction.”12 maud was made an honorary member of mayo clinic faculty in the late 1920s.1,14 actress megan cole portrays maud in a 30-minute documentary on her life.3,13 to prepare for the part, she studied maud’s life and work. curiously, maud, who contributed so much to the field of medical writing, did not like to write and rarely wrote anything down. as a result, most of what ms cole learned about maud came from others.13 (the 2 best sources being those by clapesattle1 and wrightpeterson.2) according to ms cole, it is clear that maud “was a gentle powerhouse, a compassionate taskmaster, and an intimidating scholar who didn’t boast about her accomplishments.”13 vitally important to the growth of the clinic and in building its reputation, she was “a brilliant editor and a woman far ahead of her time, one who raised a fairly traditional position to heights not previously imagined.”13 on the day of maud’s funeral, the clinic was closed in her honor.3 but perhaps the most appropriate honor was given by dr will himself, who considered maud to be the 4th founder of the clinic, after he, his brother, and their father.1,2 he wrote that she “was endowed with exceptional ability, untiring perseverance, sound judgment, and indomitable courage,” and “dedicated her life to the literary development of mayo clinic.”2 indeed, the profession of medical writing owes much to her contributions. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: tomlangcom@aol.com references 1. clapesattle h. the doctors mayo. wm collins sons & co; 1941. 2. wright-peterson v. women of the mayo clinic: the founding generation. minnesota historical society; 2016. 3. cole m. the engines of our ingenuity. no. 2751: mrs. wilson of the mayo clinic. october 31, 2011. accessed may 6, 2020. https:// uh.edu/engines/epi2751.htm 4. hahn a, lewis k. maud mellish wilson: mayo clinic’s first librarian and medical editor. the scribe. 2007;9:9 5. deaths. j am med assoc. 1905;44(17):1383-1384. 6. ventura ho. albert ochsner, md: chicago surgeon and mentor to alton ochsner. ochsner j. 2001;3(4):223-225. 7. swanberg h. history of the american medical writers association and its previous associated organizations. american medical writers association; 1965. 8. mayo clinic in rochester, mn: past, present, & future. minnesota’s rochester website. accessed may 7, 2020. https:// www. experiencerochestermn.com/mayo-clinic/history/ 9. lanier w. celebrating mayo clinic proceedings’ 90th anniversary: a story of longevity and progression of mission. mayo clin proc. 2016;91(1):3-9. 10. habermann tm, ziemer re, beck cs. images and reflections from mayo clinic heritage. mayo clin proc. 2001;76(10):1062. 11. warner ma. you trained at mayo clinic? wow! mayo clin proc. 2014;89(3):284-290. 12. hewitt rm. division of publications of the mayo clinic. bull med libr assoc. 1936;25(1-2):133-138. 13. cole m. maud mellish wilson: a medical editor’s story on stage. sci editor. 2010;33(4):116. 14. smallridge rc, morris jc. a century of hyperthyroidism at mayo clinic. mayo clin proc. 2016;91(1):e7-e12. 15. boes cj, long tr, rose sh, fye wb. the founding of the mayo school of graduate medical education. mayo clin proc. 2015;90(2):252-263. 16. nelson c. early mayo medical illustrating. mayo clin proc. 1995;70(8):724. 17. hickey rc. collected papers of the mayo clinic and the mayo foundation. vol. 46, 1954. ama arch intern med. 1956;97(3): 390-391. 18. mellish mh. the writing of medical papers. 1st ed. w.b. saunders company; 1922. 19. gould gm. suggestions to medical writers. philadelphia medical publishing company; 1900. 20. bett wr. the preparation and writing of medical papers for publication. menley & james; 1923. 21. albutt tc. notes on the composition of scientific papers. springer inc; 1904. 22. mellish mh. suggestions on the use of the reference library in the preparation of medical papers. bull med libr assoc. 1914;4(2): 30-34. 23. mellish m. the writing of medical papers. 3rd ed. philadelphia, pa; 1929:184. 24. simmons gh, fishbein m. the art and practice of medical writing. american medical association; 1925. 25. axen dm. the turning of a page. celebrating a century of learning with mayo clinic libraries. mayo magazine. 2007:26-28. https:// www.mayoclinic.org/documents/mc2386-au07-pdf/ doc-20078983 26. clarivate analytics. 2017 impact factor. mayo clin proc. 2017. accessed april 29, 2020. https://www.mayoclinicproceedings.org/ pb/assets/raw/health%20advance/journals/jmcp/if1.pdf http://www.amwajournal.org https://uh.edu/engines/epi2751.htm https://uh.edu/engines/epi2751.htm https://www.experiencerochestermn.com/mayo-clinic/history/ https://www.experiencerochestermn.com/mayo-clinic/history/ https://www.mayoclinic.org/documents/mc2386-au07-pdf/doc-20078983 https://www.mayoclinic.org/documents/mc2386-au07-pdf/doc-20078983 https://www.mayoclinic.org/documents/mc2386-au07-pdf/doc-20078983 https://www.mayoclinicproceedings.org/pb/assets/raw/health%20advance/journals/jmcp/if1.pdf https://www.mayoclinicproceedings.org/pb/assets/raw/health%20advance/journals/jmcp/if1.pdf a m w a news thomas m. schindler, phd1 and gail v. flores, phd2/ 1head innovation medical writing, boehringer ingelheim pharma gmbh & co kg, biberach, germany; and 22020-2021 president, amwa; encore biomedical communications llc, encinitas, california. amwa, emwa, and ismpp promote ethical, professional medical writing in jama oncology letter to the editor in march 2021, del paggio et al. published an article in jama oncology that included disparaging comments about medical writers. american medical writers association (amwa) leaders, in partnership with representatives from the european medical writers association (emwa) and the international society for medical publication professionals (ismpp), immediately and swiftly drafted and submitted a letter of response to this article, which was published on august 26, 2021, along with 2 other letters and the authors‘ response to all 3 letters. del paggio et al.’s article reported on multiple aspects of randomized clinical trials in oncology, including the use of professional medical writers. specifically, the authors stated, “there is reason to be concerned that medical writers may unduly influence the interpretation of trials, … as it is unlikely that medical writers have a neutral effect on the clinical trial reporting.”1 although we all share an understanding of the value of medical writers, it is imperative that we respond publicly to these attacks to safeguard the reputation of our profession. as highlighted in our letter, the use of our profession’s expertise improves accuracy, timeliness, and adherence to ethical conduct. evidence from independent research on the benefits of working with medical writers was included in the response. the commitment of medical writers to adhere to good publication practice (gpp3) guidelines and to ethical principles in scientific publishing as well as to the professional codes of conduct of their professional organizations was also identified as a significant benefit of working with professional medical writers. although the letter is behind a paywall, jama oncology has granted the authors free access to the full text to share with our members; note that this link should not be shared outside of the amwa membership. author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. author contact: thomas.schindler@boehringer-ingelheim.com; gflores@encorebiomed.com references 1. del paggio jc, berry js, hopman wm, et al. evolution of the randomized clinical trial in the era of precision oncology. jama oncol. 2021;7(5):728-734. doi:10.1001/jamaoncol.2021.0379 amwa journal / v36 n4 / 2021 / amwa.org 185 https://jamanetwork.com/journals/jamaoncology/article-abstract/2783530?guestaccesskey=e38e72e5-1cde-42ac-a66e-f0495987b788 https://jamanetwork.com/journals/jamaoncology/article-abstract/2777587 98 amwa journal / v36 n2 / 2021 / amwa.org amwa2021save the datesave the date spotlight on medical communication: disruption, innovation, and resilience join us october 27-30, 2021 to gain a better understanding of trend-setting topics such as 2021 amwa medical writing & communication conference october 27-30, 2021 trends and opportunities for medical communicators amwa's 2021 medical writing & communication conference will be held virtually on october 27-29, 2021. 2020 delivered disruption, ignited innovation, and required resilience in our professional and personal lives. #amwa2021 will shine a spotlight on the importance of medical communication, and the strength and commitment of the medical writing community, during these difficult yet amazing times. in making the decision to go virtual, amwa relied on public health guidance, federal and state-by-state event restrictions, and member survey feedback and concluded that is not feasible to plan and implement an in-person, large-scale, multiday conference for the amwa community this fall. we are redoubling our efforts to ensure that #amwa2021 delivers the best content and experiences possible. building on our success from last year’s first virtual conference, we will be creating an online experience that meets attendees’ professional development and networking needs. join us for engaging education sessions with live chats; small-group, interactive roundtable discussions; insightful poster presentations, and inspiring plenary sessions. we will also celebrate the accomplishments of our colleagues and peers over the past year. profiles of amwa’s award winners can be found in this issue. #amwa2021 education session preview • a systematic approach to manuscript editing • best practices for medical writing with a disclosure mindset • bridging the gap: transitioning into regulatory medical writing • catapult your career using linkedin • copyright 101: a practical guide to properly reusing and sharing journal publications information • data, design, and technology: effective infographic strategies for health communication • describing mental disorders using the language of neuroscience • how to master scientific publications: a medical writer’s bag of tricks • launching and building a freelance business: a proven 10-step process • leveraging accessibility best practices to elevate your social media and health communication strategies • not a ghost in the machine: building a rich, virtual culture • sales training and beyond: developing educational content across the pharma/biotech landscape • teaching the next generation of regulatory medical writers • the case for business intelligence in medical writing • wfh! wtf? what i’ve learned from 32 years of working from home that might just help you survive and many more! sarah dobney, mph / amwa annual conference chair, galion, oh full program and registration information available at www.amwa.org/conference. we look forwarding to seeing you online for #amwa2021! author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: conference@amwa.org http://www.amwa.org/conference mailto:conference@amwa.org v37 n2 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 4 abstract peer-reviewed scientific publications are written by scientists with peers in mind. however, there is a growing demand of patients and other nonspecialists to understand the potential implications of clinical and medical research. research summaries of scientific articles in easy-to-read language— called plain language summaries (pls)—are currently being developed to broaden the reach of scientific articles beyond expert audiences. while pls can help nonexperts to understand and be informed about scientific articles, there is a risk that pls contribute to publication bias and hence misinformation of patients and the public and thus achieve the opposite of their intention. potential issues are an unbalanced selection of the scientific source articles for which a pls is initiated, lack of alignment of the data presented in the pls and in the source article, unbalanced reporting of efficacy and safety data, absence of reporting the primary endpoint, or overor underreporting of secondary endpoint results. to objectively inform patients and to become a trustworthy source of information, the writing of pls needs to be firmly embedded in a set of ethical principles. to safeguard balanced and fair pls writing, the cocreated “how-to” guide on pls writing developed by the patient focused medicines development initiative comprises a set of 15 ethical considerations. these include the necessity for objective reporting, the need for balanced presentation, the importance of audience focus, the need to apply health literacy principles, and the importance of using inclusive and respectful language. the “how-to” guide was developed in a stepwise process with several rounds of cocreation, public consultation (two rounds), internal review, and a final external review. the iterative development process ensured input from a wide variety of stakeholders (patient representatives, industry members, publishers, researchers, medical communications agencies, and public officials involved in research bodies). the final “how-to” guide is a standalone, practical, ready-to-use tool to support multistakeholder cocreation of pls. peer-reviewed scientific publications are the established channels through which researchers share results and data with their peers. these communications are typically written by scientists with peers and fellow experts in mind and are characterized by extensive use of technical language and complex graphical representations. scientific articles are therefore often impenetrable for nonspecialist audiences. on the other hand, patients, patient organizations, and other nonexperts want to be informed about scientific research results that may impact on them or to whose generation they have contributed, eg, as participants in clinical trials or by anonymously being a included in health resource use study. patients and their caregivers want to know what the research activity may mean for them and the conditions they are living with.1-3 plain language summaries (pls) are summaries of scientific articles written in easy-to-read, nontechnical language. they have the potential to increase the understanding of scientific data by making complex information more accessible to wider audiences. this includes patient organizations, patients, caregivers, healthcare professionals from different fields, and the public.4-6 by improving knowledge and understanding of clinical research, pls may facilitate patient–physician communication that could contribute to shared decision-making. importantly, pls are only of value when facts, numbers, and conclusions are conveyed truthfully and objectively, without promotional intent or spin. pls can only fulfil their objectives if readers can fully trust that all relevant data—including information on the uncertainty of research conclusions—have been made available to them. thus, the writing of pls needs to be based on ethical considerations and requires a documented institutional framework. the number of pls associated with peer-reviewed publications is still relatively low, and there is currently wide variation in content, format, quality, and location (i.e., where people can access them) of pls.7 efforts are generating plain language summaries of scientific publications with ethical foundations: a practical “how-to” guide cocreated with patients thomas m. schindler, phd / boehringer ingelheim pharma gmbh & co kg and lay & regulatory writing, biberach a. d. riss, germany theme article http://www.amwajournal.org amwajournal.org 5generating plain language summaries of scientific publications ongoing to provide guidance, and minimum standards for pls have recently been proposed.8-10 however, previous guidelines do not address the need of ethical considerations for the generation of pls nor do they provide guidance on cocreation with the target audience. in line with key ethical principles formulated in the declaration of helsinki11 that have become the basis for all clinical research in humans, members of the science communication continuum, ie, researchers, authors, sponsors, editors, and publishers, share the obligation to appropriately and ethically share the results of research (principle 36). an ethical key consideration for pls writing that expresses respect for potential and enrolled subjects of clinical research is the aspect of cocreation. pls should be prepared in collaboration with members of the target audience to achieve an optimal outcome in respect to adequacy of content and presentation.12 however, in current practice, patient involvement is often restricted to the late stages of pls development, for example the review process. the need for a practical “how-to” guidance that will ensure both ethical considerations and early involvement of patients was recognized by patient focused medicines development (pfmd).13 pfmd is a collaboration of health stakeholders, including publishers, patient organizations, and pharmaceutical companies, whose aim is to facilitate patient engagement (pe) across the medicine development lifecycle. cocreation of the “how-to” guide for the development of the “how-to” guide on pls, an international working group was established, and members were required to have pe experience and/or expertise in generating pls. the “how-to” guide was developed in a stepwise approach using established cocreation methodology.14-16 this included several rounds of cocreation, public consultation, internal review, and an external review. feedback from each step in the review process was used to refine the draft “how-to” guide, which was then validated through additional consultation. the first round of public consultation focused on the content, while the second public consultation gathered feedback on the usability and the associated user experience; a detailed description of the process is provided by dormer et al.17 ethical considerations for pls writing according to the declaration of helsinki,11 a universally accepted ethical standard for medical research in humans, researchers, editors, and publishers have ethical obligations regarding the publication and dissemination of the results of research (principle 36). these actors in the biomedical communication continuum are accountable for completeness and accuracy of their reports and that negative and inconclusive as well as positive results are published or otherwise made publicly available (principle 36). compliance with ethical principles is particularly relevant for pls because they are intended for patients and nonexperts who are likely lacking the expertise to detect potential methodological flaws in scientific publications. in this regard, patients, caregivers, and other nonexperts constitute a vulnerable group that needs to be protected from harm inflicted by misinformation. while scientists are trained in presenting research in a structured way, the common format is alien to most patients and nonexperts. hence, authors, editors, and publishers have the obligation to minimize the potential for misunderstanding of scientific results that are presented in pls. this is supported by the 15 ethical considerations included in the “how-to” guide. the considerations cover the necessity for objective reporting, the need to apply health literacy principles, the importance of audience focus and the absence of any promotional intent, the need for balanced presentation, and the importance of using inclusive and respectful language. it is also essential for both sponsors and journals to have a consistent policy for the development and publishing of pls. this means there should be transparent, prospective, and objective selection criteria for choosing publications from which to develop pls and for deciding how and when they will be published to prevent publication bias. for example, one criterion from a sponsor could be a commitment to producing pls for all phase 3 trials, regardless of outcomes. pls on single trials need to include a disclaimer on the limitations and generalizability of the results. details on the ethical principles are provided in table 1. table 1. ethical considerations for pls writing any statement in the pls should be objective and aligned with the data provided in the scientific publication. health literacy and numeracy principles should be applied in the writing and design of the pls. the choice of words should be neutral and factual. superlative and emotional words, phrases, and metaphors should be avoided. the pls should be free of any commercial bias and must be strictly nonpromotional. for pls linked to primary scientific publications of clinical trials, there should be a balanced presentation of efficacy and safety data. the overall objective (ie, the primary objective) of the research that is reported needs to be described in the respective pls. all data provided in the pls should also be given in the scientific article. the data presented in a pls should not go beyond the data provided in the scientific article. table continued on next page http://www.amwajournal.org amwajournal.org 6generating plain language summaries of scientific publications cocreation of content expresses respect for the target audience and hence is an important aspect in generating pls of peer-reviewed scientific publications. the methodology proposed in the “how-to” ensures adequate representation of the target population. seven steps for generating a pls: proposed algorithm the generation of pls was broken down into seven steps that serve the overall aims of maximum audience focus and full cocreation with members of the target audience. a summary is provided in table 2 below; a more detailed description is available in dormer et al.17 discussion and conclusion the field of pls writing is evolving as more and more journals provide the opportunity for pls.5-7 some guidelines for the content of pls have been published by collaborative networks such as cochrane8,9 and open pharma.10 although these guidelines are applicable to all pls, they do not explicitly provide ethical considerations, and they provide no methodology for cocreation of pls with members of the target audience. it is very important to realize that pls table 2. seven steps of creating a pls step action content 1 have a rationale and scope for developing the pls the selecting criteria for the source scientific publication for a pls must be clear before the writing is initiated. it is important to have a transparent process, such as a standard operating procedure, across an organization, to avoid publication bias by selectively providing pls. reasons for a pls could be the impact of the data, the uniqueness of the scientific approach, or the needs of a certain audience. 2 identify the target audience the target audience should be defined before the start of the writing process. this choice will impact the resource needs in the cocreation process and will determine the administrative and operational complexity of the pls writing. 3 consider the dissemination channels it is essential to consider the dissemination of the pls based on the identified target audience. free access is important to optimize distribution. the method of dissemination will influence the amount of aggregation and summarization of data from the source article. for example, if a manuscript and its pls appear in the same issue of a journal, certain details may be omitted from the pls and provided solely as reference to the source. some journals may allow the inclusion of supplementary material, eg, for additional infographics. 4 identify key stakeholders for cocreation it is important to identify the key stakeholders for their engagement in cocreation before a pls is written. it is desirable to have a broad range of stakeholders, including patients, caregivers, and others. the pls cocreators should determine whether they have the appropriate reach into the target audience or whether new cocreation relationships need to be established. resourcing (eg, contracting, payment, technical infrastructure) and any applicable legal requirements need to be considered to ensure that relationships can be maintained throughout the process. 5 write pls pls cocreators should establish an appropriate infrastructure and should agree on roles and interaction in the writing process. based on the target audience, the pls cocreators need to decide on the literacy level and the structure of the pls and the use of visuals or infographics. it is highly recommended to have a member of the target audience review the draft pls. the pls must reference the source scientific article or contain a link to it. 6 disseminate pls once the pls is published, it may be shared in print, in online repositories, or on relevant websites; the channels should be chosen based on target audience preference. the use of social media for dissemination depends on the legal restrictions in some countries and the corresponding compliance rules in large organizations. 7 track dissemination and measure success ways to monitor the impact of the pls should be developed to gauge future efforts. various metrics may be available depending on where a pls is located/hosted. the journal site/website/repository that hosts the pls might provide metrics such as the number of views or downloads. another measure is the attention the pls or the source article has received on social media or in other commentaries. posts on social media that link to the pls may be liked or shared, and monitoring this activity can provide an indication of the reach of the pls. it should also be measured whether the pls is shared by patient organizations and healthcare providers in the respective disease area. the results of the primary endpoint need to be described and explained in the pls when reported in the scientific publication. results of key secondary endpoints could be included if they have been prespecified in the study protocol or analysis plan, are statistically powered and analyzed, and are of particular relevance to patients. the pls needs to mention the important limitations of the research or study that is reported in the scientific article. to make pls accessible for patients whose native language is not english, appropriate translations should be done that faithfully reflect the content of the pls. translations need to be mindful of the cultural diversities between audiences and ideally reviewed by members of the target audience for each language. the pls should be inclusive of all genders, nationalities, and ethnicities. the pls should be reviewed by members of the public and/or by patients or patient representatives ideally with the condition that was studied in the scientific article. the pls should be approved by the lead author (the author who is named first in the author list) of the scientific article, as a minimum. all authors of the scientific article on which the pls is based should be given the opportunity to review and comment on the pls. the authors of the pls as well as the funding source of the research work and the funding of the pls should be disclosed in the pls. links to the scientific publication should be included in the pls. table 1. ethical considerations for pls writing (continued) http://www.amwajournal.org amwajournal.org 7generating plain language summaries of scientific publications written without strict consideration of ethical principles bear the risk of contributing to misinformation rather than providing insight and understanding to nonexperts. to make this new format a trustworthy source for patients, caregivers, and others, a firm commitment to ethical conduct in pls writing is mandatory. however, while not being explicit about their ethical considerations, the existing guidelines8,9 stipulate a number of requirements that are in line with the recommendations of the pfmd guidance. for example, the cochrane collaboration mentions consistency between the source and the pls and the need to report the primary outcome as well as balanced reporting of efficacy and safety data as mandatory requirements.8 interestingly, in the latest version of the cochrane guidance published in january 2022, the ethical considerations in regard to content of pls, are substantially less explicit than in the previous version.9 the open pharma collaboration mentions that pls need to be nonpromotional and unbiased and that pls need to include a link to the source publication.10 in a recently published modified delphi approach of stakeholders’ perceptions of issues in generating pls,18 a number of items emerged as “important” that are in line with the ethical considerations put forward in the pfmd guidance. stakeholders considered it “important” that the primary endpoint results are included in the pls as well as mentioning the limitations of the study. other obligations related to ethical conduct, such as having the authors of the source article approve the pls, are only to be “considered” in pls generation, according to this stakeholder group. in summary, the “how-to” guide developed by pfmd is the first one to more explicitly require compliance with a set of ethical considerations. the value of these stipulations was corroborated by the fact that the “how-to” guide had been developed using an iterative and robust co-creation methodology with substantial public consultation.14-16 to ease implementation, selected resources for pls development, complementary tools, and good-practice examples are available directly in the “how-to” guide. the “how-to” guide19 has been uploaded onto the pfmd pe management suite, a central repository that allows open access to all pfmd tools. acknowledgment i take full responsibility for the content and the presentation. however, i thankfully acknowledge the discussions within the pfmd pls working group on the topic. the members of the pls guidance core team were laura dormer, lauri arnstein williams, dawn lobban, sheila khawaja, amanda hunn, daniela luzuriaga ubilla, and anne-marie hamoir. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: lay_and_regulatory_writing@gmx.de references 1. pushparajah ds, manning e, michels e, arnaudeau-bégard c. value of developing plain language summaries of scientific and clinical articles: a survey of patients and physicians. ther innov regul sci. 2018;52(4):474-481. https://doi. org/10.1177/2168479017738723 2. geissler j, ryll b, leto di priolo s, uhlenhopp m. improving patient involvement in medicines research and development: a practical roadmap. ther innov regul sci. 2017;51(5):612-619. https://doi.org/10.1177/2168479017706405 3. dietrich, j, alivojvodic j, seliverstov i, metcalf m, jakee k. improving information exchange with clinical trial participants: a proposal for industry. ther innov regul sci. 2017;51(5):542-550. https://doi.org/10.1177/2168479017725109 4. kerwer m, chasiotis a, stricker j, günther a, rosman t. straight from the scientist’s mouth—plain language summaries promote laypeople’s comprehension and knowledge acquisition when reading about individual research findings in psychology. collabra psychol. 2021;7(1):18898. https://doi.org/10.1525/ collabra.18898 5. nunn e, pinfield s. lay summaries of open access journal articles: engaging with the general public on medical research. learn publ. 2014;27(3):173-184. https://doi.org/10.1087/20140303 6. anstey a. plain language summaries in the british journal of dermatology: connecting with patients (editorial). br j dermatol. 2014;170(1):1-3. https://doi.org/10.1111/bjd.12760 7. fitzgibbon h, king k, piano c, wilk c, gaskarth m. where are biomedical research plain‐language summaries? health sci rep. 2020;3(3):e175. https://doi.org/10.1002/hsr2.175 8. mcilwain c, santesso n, simi s, et al. standards for the reporting of plain language summaries in new cochrane intervention reviews version 1. cochrane: london. 2013. available from: training.cochrane.org/resource/cochrane-standards-preparingplain-languagesummaries 9. pitcher n, mitchell d, hughes c. template and guidance for writing a cochrane plain language summary. version 1 january 2022. accessed april 25, 2022. https://training.cochrane.org/guidance-writing-cochrane-plainlanguage-summary 10. rosenberg a, baróniková s, feighery l, et al. open pharma recommendations for plain language summaries of peerreviewed medical journal publications. curr med res opin. 2021;37(11):2015-2016. https://doi.org/10.1080/03007995.2021.19 71185 11. wma declaration of helsinki – ethical principles for medical research involving human subjects. world medical association. published 2018. accessed march 10, 2022. https://www.wma.net/ policies-post/wma-declaration-of-helsinki-ethical-principles-formedical-research-involving-human-subjects/ 12. emanuel ej, wendler d, grady c. what makes clinical research ethical? jama 2000;283(20):2701-2711. https://doi.org/10.1001/ jama.283.20.2701 http://www.amwajournal.org https://doi.org/10.1177/2168479017738723 https://doi.org/10.1177/2168479017738723 https://doi.org/10.1177/2168479017706405 https://doi.org/10.1177/2168479017725109 https://doi.org/10.1525/collabra.18898 https://doi.org/10.1525/collabra.18898 https://doi.org/10.1087/20140303 https://doi.org/10.1111/bjd.12760 https://doi.org/10.1002/hsr2.175 http://training.cochrane.org/resource/cochrane-standards-preparing-plain-languagesummaries http://training.cochrane.org/resource/cochrane-standards-preparing-plain-languagesummaries https://training.cochrane.org/guidance-writing-cochrane-plain-language-summary https://training.cochrane.org/guidance-writing-cochrane-plain-language-summary https://doi.org/10.1080/03007995.2021.1971185 https://doi.org/10.1080/03007995.2021.1971185 https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ https://doi.org/10.1001/jama.283.20.2701 https://doi.org/10.1001/jama.283.20.2701 amwajournal.org 8generating plain language summaries of scientific publications 13. patient focused medicines development. workshop 3: the role of patients in co-designing plain language summaries. published 2019. accessed march 10, 2022. https://patientengagementopenforum.org/docs/workshop-3-pein-pls-development.pdf 14. deane k, delbecque l, gorbenko o, et al. co-creation of patient engagement quality guidance for medicines development: an international multistakeholder initiative. bmj innov. 2019;5(1):4355. https://doi.org/10.1136/bmjinnov-2018-000317 15. feldman d, kruger p, delbecque l, et al. co-creation of practical “how-to guides” for patient engagement in key phases of medicines development—from theory to implementation. res involv engagem. 2021;7(1):57. https://doi.org/10.1186/s40900021-00294-x 16. patient focused medicines development. practical how-to guides for patient engagement. accessed march 10, 2022. https://pemsuite.org/how-to-guides/ 17. dormer l, schinder t, arnstein-williams l, et al. a practical ‘how-to’ guide to plain language summaries (pls) of peerreviewed scientific publications: results of a multi-stakeholder initiative utilizing co-creation methodology. res involv engagem, 2022;8(1):23. https://doi.org/10.1186/s40900-022-00358-6 18. lobban d, gardner j, matheis r. plain language summaries of publications of company-sponsored medical research: what key questions do we need to address? curr med res opin. 2022;38(2): 189-200. https://doi.org/10.1080/03007995.2021.1997221 19. patient focused medicines development. how-to guides for patient engagement: plain language summaries (pls) of peerreviewed publications and conference presentations: practical ‘how-to’ guide for multi-stakeholder co-creation. accessed march 10, 2022. https://pemsuite.org/how-to-guides/wg5.pdf amwa live webinars tools, tips, and tricks for medical communicators. www.amwa.org/events only $20 for members can’t attend a live webinar? you won’t miss out! all registrations for live webinars include access to the recorded video in amwa online learning. http://www.amwajournal.org https://patientengagementopenforum.org/docs/workshop-3-pe-in-pls-development.pdf https://patientengagementopenforum.org/docs/workshop-3-pe-in-pls-development.pdf https://doi.org/10.1136/bmjinnov-2018-000317 https://doi.org/10.1186/s40900-021-00294-x https://doi.org/10.1186/s40900-021-00294-x https://pemsuite.org/how-to-guides/ https://pemsuite.org/how-to-guides/ https://doi.org/10.1080/03007995.2021.1997221 https://pemsuite.org/how-to-guides/wg5.pdf amwa journal / v36 n1 / 2021 / amwa.org 3 w elcome to the 2021 spring issue of the amwa journal. as i write this, amwa is in the final stages of selecting the journal’s new editor in chief (eic), who will be in place at the time this issue is published. i hope you are as excited as i am to “meet” the new eic in the next issue and see how they will work with the editorial board to help guide and shape the journal in the coming years. in this issue, you will find both articles featuring 2020 amwa award winners and session reports from amwa’s successful 2020 annual medical writing & communication conference. despite this event being held virtually, attendance was high, and attendee reviews have been excellent. once again, the volume of rich content included in the plenary sessions, open sessions, and roundtables was too large to capture in a single issue—so be on the lookout for other content inspired by our conference presenters as upcoming amwa webinars, knowledge builders, and other activities in amwa online learning. speaking of amwa online learning, have you checked out the catalog lately? our education department has been very busy, continuing its momentum from 2020 into the new year by delivering fresh content and developing new webinars, knowledge builders, and other offerings. and the valuable opportunities to learn are not just limited to the online learning catalog! new posts are continually being added to the amwa blog (https://blog.amwa.org), and amwa’s medical communications news, which is delivered to your inbox on a regular basis, has recently gotten a new look. did you know that amwa has a youtube channel (https://www.youtube.com/c/americanmedicalwritersassociation) that houses videos highlighting members discussing trends in medical writing and the features of amwa? be sure to open your emails from amwa and follow amwa on social media so you don’t miss any of this valuable content! when this issue is published, it will mark about a year since our daily lives were changed dramatically due to covid-19–related stay-at-home orders. for those of who have lost loved ones or whose lives and livelihoods have otherwise been forever changed, please accept my condolences. i never expected my term as amwa president to start entirely from my home, without a single in-person interaction or hug. yet i’ve so enjoyed the smiles i get from my amwa colleagues at virtual chapter networking events and governance meetings, as well as chatting on engage, on linkedin, and in the conference platform. thanks once again to our chapter leaders for keeping the online networking and programming going so that amwa members can continue to feel like a part of the amazing community that is amwa. yours, gail from the president gail v. flores, phd / 2020–2021 amwa president https://blog.amwa.org https://www.youtube.com/c/americanmedicalwritersassociation 90 amwa journal / v36 n2 / 2021 / amwa.org introduction highly trained medical writers are typically familiar with case studies of scientific misconduct, defined as data fabrication, data falsification, and plagiarism.1 however, less than 2% of researchers are thought to engage in scientific misconduct.2 in recognition that avoiding scientific misconduct is only a small part of research ethics, the national institutes of health (nih) released the following statement in 2009: “[r]esponsible conduct of research is defined as the practice of scientific investigation with integrity. it involves the awareness and application of established professional norms and ethical principles in the performance of all activities related to scientific research.”3 this guiding principle can be used to shape every aspect of our work when developing grant proposals. the ethical codes from the american grant writers’ association4 and the grant professionals association5 highlight key ethical issues for grant writers, including avoiding conflicts of interest, following confidentiality guidelines, avoiding plagiarism, and accurately representing the prior work and future capabilities of the funding recipient. they also describe the importance of not allowing payment to be contingent on grant success. this article addresses additional areas in which we commonly see room for improvement for the medical writer regarding research ethics, with a focus on nih proposals. the nih supports the work of over 300,000 biomedical scientists through competitive research funding amounting to $41.7 billion in 2020,6 making the nih the largest public funder of research worldwide. the nih received 54,903 research grant proposals in 2019,7 many of which were written or edited by professional medical writers. in the last half decade, the nih has taken concrete action to improve the responsible conduct of research. in late 2015, the nih released a major change to the application instructions and review criteria for research projects, called “implementing rigor and transparency in nih & ahrq research grant applications,”8 which was updated in 2018.9 chris s. gandhi1 and nancy linford2 / 1beckman research institute of city of hope, duarte, ca; 2linford biomedical communications, seattle, wa everyday ethics considerations for developing ethical biomedical grant proposals for the national institutes of health in 2020, the nih also released an updated policy for data management and sharing (dms),10 which builds upon existing requirements for disseminating research results to the public. these policy statements cover a range of ethical issues in biomedical research, which will be discussed in the next sections. the portions of these policy statements that focus on clinical research design and dissemination of human subjects’ research data will not be covered here, as those topics are beyond the scope of this article. given that one of the medical writer’s responsibilities is to ensure that the text is compliant with the funder’s policies, the new nih policy statements represent important areas in which the medical writer can make a positive impact on ethical conduct in the grant development process. research plan: enhancing rigor and reproducibility the reviewers will assess 4 elements of rigor.8,9,11 below are descriptions of those elements and recommendations to consider. 1. rigor of the prior research. when justifying the research aims, typically in the significance section, applicants may be tempted to focus solely on their work and to emphasize only the positive. however, such a narrow focus can give reviewers a biased impression of the state of the field. therefore, applicants are encouraged to write a more balanced narrative describing the strengths and weaknesses of prior work in light of the whole field and acknowledging competing viewpoints. table 1. considerations for describing rigor of the prior research ✓ does the significance section refer to work performed by other research groups? ✓ does the significance section critically appraise the technical and/or intellectual rigor of prior work by the applicant and by others? ✓ does the significance section address whether the prior work led to consensus or controversy? amwa journal / v36 n2 / 2021 / amwa.org 91 2. rigor of the proposed work. when describing the current research plans in the approach section, applicants must justify their experiments in light of the weaknesses in prior work. this justification could be as obvious as clarifying the research milestone that made the present work possible, or it could be more complicated, especially if the proposed work attempts to overcome a controversy. asserting the rigor of the proposed work also means providing enough detail on the experimental plans and statistical analysis for reviewers to have confidence that the research team can navigate experimental subtleties to arrive at meaningful answers. consensus guidelines for reporting research results, such as arrive (animal research: reporting of in vivo experiments), can clarify how much detail to include in the study design.12,13 3. biological variables. to enhance reproducibility, applicants are expected to justify the experimental design and analysis choices in light of the relevant biological variables that may impact the interpretation of results. the nih uses a broad definition of biological variables, including intrinsic factors (eg, sex, weight, age, and genetic background) and extrinsic factors (eg, food source and housing conditions for animal studies).14 in particular, for work with human subjects or vertebrate animals, reviewers will evaluate whether the proposal adequately considers sex as a biological variable, and strong justification is required for experiments using only one sex.15,16 4. authentication. research performed with reagents that are unreliable or mislabeled can lack reproducibility. thus, applicants must briefly describe the plan for validating key biological and chemical resources, such as cell lines, antibodies, specialty chemicals, and transgenic animals.17 the goal is to describe the methods used to validate reagents, including validation performed by commercial sources. data management and sharing plan: storing and disseminating biomedical research data because science advances through building on past findings, sharing data is a best practice that positively benefits applicants, their fields, and funding agencies. additionally, because the nih uses public funds, there is an additional ethical duty to share research findings with the public. the current nih data sharing policy18 went into effect in 2003 and remains in effect until january 2023. under the 2003 policy, all investigator-initiated applications seeking >$500,000 in direct costs per year, or as specified in the individual funding opportunity announcement (foa), are required to include a plan for the sharing of final research data or a justification for why data sharing is not possible (eg, privacy concerns, third-party agreements, and national security issues). this policy was extended in 2014 by the genomic data sharing policy, which establishes expectations for the broad and responsible sharing of genomic research data.19 beginning in 2023, all nih applications must include a dms plan and adhere to the updated nih policy10 and supplemental information,15,20,21 including abiding by fair (findable, accessible, interoperable, and reusable) data principles.22 because the 2023 policy includes all of the elements of the 2003 policy and expands upon several key concepts, we will focus on the ethical considerations for writing a dms plan that complies with the newer guidance. dms plans will be evaluated for compliance in the following areas20: 1. data type, common data standards, and repository selection. applicants are expected to describe what types of data and accompanying metadata will be preserved and shared and what common data standards will be applied to the shared data and metadata, if applicable. decisions on what to preserve and share should be based on justifiable ethical, legal, and technical considerations. applicants are strongly encouraged to use existing data repositories, especially those that follow fair principles. the nih does not always require deposition into an nih-supported repository, so it can be appropriate to consider third-party repositories. everyday ethics table 2. considerations for describing rigor of the proposed work ✓ does the approach section explain how the current research plans fill any knowledge gaps left by prior work? ✓ does the approach section provide sufficient methodological detail to demonstrate that the applicants know the pitfalls in their field and how to avoid them? ✓ does the approach section provide a statistical analysis plan, including a power analysis when appropriate? table 3. considerations for accounting for biological variables ✓ does the approach section consider sex as a biological variable in the design and analysis of work with human subjects or vertebrate animals? ✓ does the approach section consider additional biological variables, especially those recognized as important in prior research in the field? ✓ are any proposed analyses based on relevant biological variables sufficiently powered to generate meaningful results? table 4. considerations for describing authentication of reagents and key resources ✓ is there a separate authentication plan for key biological and/or chemical resources? ✓ does the authentication plan contain information about reagents and resources and not preliminary data or methods? ✓ does the authentication plan sufficiently detail how and at what frequency key resources will be authenticated? 92 amwa journal / v36 n2 / 2021 / amwa.org 2. timelines and plans for data preservation, access, and sharing. data and metadata should be preserved, at a minimum, in accordance with all applicable guidance (eg, data repository policies, specific award requirements, and journal policies). final research data and metadata should be accessible no later than the time of publication or the end of the performance period, whichever is earlier, unless there are justifiable exceptions explained in the dms plan. 3. limitations on access, reuse, and distribution. certain types of data and metadata may be confidential, sensitive, or proprietary. the nih expects data and associated metadata to be shared to the maximum extent allowable. any limitations or controls on their access, reuse, and distribution must be justified on ethical, policy-based, or legal grounds. in addition to the above considerations, the nih will also expect a statement on how the dms plan will be managed and monitored and by whom. conclusions recent world events have underscored the ethical justification to ensure biomedical research is conducted in a rigorous manner and that the fruits of research are shared with the larger scientific community and the public. for example, the coronavirus disease 2019 (covid-19) pandemic has demonstrated what the scientific community can quickly achieve when rigorous methods are applied and when high-quality data are disseminated widely and rapidly. we have focused on a subset of ethical considerations to guide the development of biomedical research grant applications for the nih; however, the underlying ethical ethos of ensuring scientific rigor and the timely sharing of scientific data can guide the development of proposals for all funding agencies. author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. author contact: chrgandhi@coh.org, nancy@linfordbiomedical.com references 1. smith r. research misconduct: the poisoning of the well. j roy soc med. may 2006;99(5):232-237. doi: 10.1258/jrsm.99.5.232 2. fanelli d. how many scientists fabricate and falsify research? a systematic review and meta-analysis of survey data. plos one. 2009;4(5):e5738. doi: 10.1371/journal.pone.0005738 3. not-od-10-019 update on the requirement for instruction in the responsible conduct of research. national institutes of health website. published 2009. accessed march 15, 2021. https://grants.nih.gov/ grants/guide/notice-files/not-od-10-019.html 4. agwa professional standards and code of ethics. american grant writers' association website. published 2016. accessed march 15, 2021. http://www.agwa.us/ethics 5. code of ethics. grant professionals association website. published 2011. accessed march 15, 2021. https://grantprofessionals.org/page/ethics 6. budget. national institutes of health website. published 2020. accessed march 15, 2021. https://www.nih.gov/about-nih/what-we-do/budget 7. extramural investments in research: fy 2019 by the numbers. open mike blog. national institutes of health website. published 2020. accessed march 15, 2021. https://nexus.od.nih.gov/all/2020/05/05/ extramural-investments-in-research-fy-2019-by-the-numbers/ 8. not-od-16-011 implementing rigor and transparency in nih & ahrq research grant applications. national institutes of health website. published 2015. accessed march 15, 2021. https://grants.nih.gov/ grants/guide/notice-files/not-od-16-011.html 9. not-od-18-228 nih & ahrq announce upcoming updates to application instructions and review criteria for research grant applications. national institutes of health website. published 2018. accessed march 15, 2021. https://grants.nih.gov/grants/guide/noticefiles/not-od-18-228.html 10. not-od-21-013 final nih policy for data management and sharing. national institutes of health website. published 2020. accessed march 15, 2021. https://grants.nih.gov/grants/guide/notice-files/not-od-21013.html 11. nih enhancing reproducibility guidelines. national institutes of health website. accessed march 15, 2021. https://grants.nih.gov/ reproducibility/documents/grant-guideline.pdf table 5. considerations for describing data types, common data standards, and repository selection ✓ does the dms plan briefly summarize the types of data and associated metadata to be preserved and shared? ✓ does the dms plan indicate what common data standards will be applied to the data and metadata? if no applicable common data standards exist, is that noted in the plan? ✓ does the dms plan identify appropriate nih-supported or third-party data repository archive(s)? ✓ does the dms plan indicate if the selected archive(s) is limited to certain data types? if required by the foa, does the dms plan affirm the use of a designated nih-supported repository? table 6. considerations for describing data preservation, access, and sharing ✓ does the dms plan conform to fair principles for the identification, access, and reuse of shared data and metadata? does the dms plan indicate how shared data and metadata will be findable and identifiable? ✓ does the dms plan affirm an acceptable timeline for sharing data and metadata? ✓ if specialized tools are needed to access or manipulate shared scientific data and metadata to support reuse or replication, will these tools be available as long as the data are shared? how can these tools be accessed? table 7. considerations for describing limitations on access, reuse, and distribution ✓ if the data and/or metadata are confidential, sensitive, or proprietary, has a reasonable justification for exclusion from sharing been provided in the dms plan? ✓ are there any restrictions on how data can be accessed, reused, or distributed, for example, only with explicit approval? ✓ if there are no limitations, has that been indicated? everyday ethics mailto:chrgandhi@coh.org mailto:nancy@linfordbiomedical.com https://grants.nih.gov/grants/guide/notice-files/not-od-10-019.html http://www.agwa.us/ethics https://grantprofessionals.org/page/ethics https://www.nih.gov/about-nih/what-we-do/budget https://nexus.od.nih.gov/all/2020/05/05/extramural-investments-in-research-fy-2019-by-the-numbers/ https://grants.nih.gov/grants/guide/notice-files/not-od-16-011.html https://grants.nih.gov/grants/guide/notice-files/not-od-18-228.html https://grants.nih.gov/grants/guide/notice-files/not-od-18-228.html https://grants.nih.gov/grants/guide/notice-files/not-od-18-228.html https://grants.nih.gov/grants/guide/notice-files/not-od-21-013.html https://grants.nih.gov/grants/guide/notice-files/not-od-21-013.html https://grants.nih.gov/reproducibility/documents/grant-guideline.pdf amwa journal / v36 n2 / 2021 / amwa.org 93 12. percie du sert n, hurst v, ahluwalia a, et al. the arrive guidelines 2.0: updated guidelines for reporting animal research. plos biology. 2020;18(7):e3000410. doi: 10.1371/journal.pbio.3000410 13. reporting guidelines. equator network website. accessed march 15, 2021. https://www.equator-network.org/reporting-guidelines/ 14. consideration of relevant biological variables in nih grant applications. open mike blog. national institutes of health website. published 2016. accessed march 15, 2021. https://nexus.od.nih.gov/all/2016/01/29/ consideration-of-relevant-biological-variables-in-nih-grantapplications/ 15. arnegard me, whitten la, hunter c, clayton ja. sex as a biological variable: a 5-year progress report and call to action. j womens health. 2020;29(6):858-864. doi: 10.1089/jwh.2019.8247 16. not-od-15-102 consideration of sex as a biological variable in nihfunded research. national institutes of health website. published 2015. accessed march 15, 2021. https://grants.nih.gov/grants/guide/noticefiles/not-od-15-102.html 17. not-od-17-068 reminder: authentication of key biological and/or chemical resources. national institutes of health website. published 2017. accessed march 15, 2021. https://grants.nih.gov/grants/guide/ notice-files/not-od-17-068.html 18. not-od-03-032 final nih statement on sharing research data. national institutes of health website. published 2003. accessed march 15, 2021. https://grants.nih.gov/grants/guide/notice-files/not-od-03032.html 19. not-od-14-124 nih genomic data sharing policy. national institutes of health website. published 2014. accessed march 15, 2021. https:// grants.nih.gov/grants/guide/notice-files/not-od-14-124.html 20. not-od-21-014 supplemental information to the nih policy for data management and sharing: elements of an nih data management and sharing plan. national institutes of health website. published 2020. accessed march 15, 2021. https://grants.nih.gov/grants/guide/noticefiles/not-od-21-014.html 21. not-od-21-016 supplemental information to the nih policy for data management and sharing: selecting a repository for data resulting from nih-supported research. national institutes of health website. published 2020. accessed march 15, 2021. https://grants.nih.gov/ grants/guide/notice-files/not-od-21-016.html 22. wilkinson md, dumontier m, aalbersberg ij, et al. the fair guiding principles for scientific data management and stewardship. sci data. 2016;3:160018. doi: 10.1038/sdata.2016.18 everyday ethics unlock the secrets to freelance success with this 3-part on-demand video series. gain relevant and practical advice from industry pros. run your business like a pro. • essential ingredients of a successful freelance business • bad behaviors that can sabotage your business • getting the clients you deserve unlock now in amwa online learning: www.amwa.org/freelance_success https://www.equator-network.org/reporting-guidelines/ https://nexus.od.nih.gov/all/2016/01/29/consideration-of-relevant-biological-variables-in-nih-grant-applications/ https://grants.nih.gov/grants/guide/notice-files/not-od-15-102.html https://grants.nih.gov/grants/guide/notice-files/not-od-15-102.html https://grants.nih.gov/grants/guide/notice-files/not-od-17-068.html https://grants.nih.gov/grants/guide/notice-files/not-od-03-032.html https://grants.nih.gov/grants/guide/notice-files/not-od-03-032.html https://grants.nih.gov/grants/guide/notice-files/not-od-14-124.html https://grants.nih.gov/grants/guide/notice-files/not-od-14-124.html https://grants.nih.gov/grants/guide/notice-files/not-od-21-014.html https://grants.nih.gov/grants/guide/notice-files/not-od-21-014.html https://grants.nih.gov/grants/guide/notice-files/not-od-21-016.html http://www.amwa.org/freelance_success by putting lives first, we’ve created a legacy that lasts for nearly 130 years, we have tackled some of the world’s biggest health challenges and provided hope in the fight against disease, for both people and animals. today, we continue our commitment to be the premier research-intensive biopharmaceutical company in pursuit of medical breakthroughs that benefit patients and society for today, tomorrow and generations to come. copyright © 2020 merck sharp & dohme corp., a subsidiary of merck & co., inc. all rights reserved. us-non-04146 02/20 join our talented community in medical writing! email us at medicalwriting2@merck.com or go to www.merck.com/careers; search medical writer mailto:medicalwriting2@merck.com http://www.merck.com/careers amwa journal / v36 n1 / 2021 / amwa.org 33 https://www.whitsellinnovations.com/ ℠ all wi employees are 100% remote, and everyone has a different ideal view. happy writers, qc and publishing specialists, and support staff result in happy clients. we are always hiring rock stars tell us about your view at www.whitsellinnovations.com/careers. at wi, our offices come with a view. http://www.whitsellinnovations http://www.whitsellinnovations https://www.whitsellinnovations.com/careers amwa_j_36.1_29_merckad amwa_j_36.1_33_wi.ad positions now open for medical writers in the us and canada. do you want to make a change as a medical writer? visit us at trilogywriting.com writers@trilogywriting.com where was it written that medical writing had to be dry, mediocre or uninspiring? sadly, it was everywhere we looked. in regulatory reports duller than butter knives. in poorly summarized summations. subpar medical writing was everywhere and spreading. so we did something about it. we waged war against mediocrity to make a change. think you have what it takes to join a world-leading team of medical writers? we’d love to speak with you. mailto:writers@trilogywriting.com http://www.trilogywriting.com 34 amwa journal / v36 n1 / 2021 / amwa.org efficacy and effectiveness in our previous article (schindler tm, bridge h. the evaluation of efficacy, or how do we know whether a treatment works? part 1. amwa j. 2020;35(2):82-86), we described how randomized clinical trials (rcts) determine efficacy of a treatment. efficacy is generally understood as the ability of a drug or other intervention to reliably produce a positive effect in patients with a defined disease under controlled conditions. in other words, clinical trials are good tools to evaluate efficacy. clinical trials provide a well-controlled framework that is characterized by the following: • selecting participants according to clearly defined eligibility criteria • randomly allocating participants to treatment groups • concealing study treatments to participants and study doctors (blinding) • clearly defining endpoint measures before study start provided a drug consistently demonstrates efficacy in several clinical studies and appears safe, regulators will approve it and permit its marketing for the treatment of a disease. however, once a drug is on the market, it will be used for the entire spectrum of patients and under circumstances that might not have been tested in the clinical studies. for example, the new drug will be used in patients who have several comorbidities in addition to the approved indication. the evaluation of a drug’s effects under everyday conditions is called effectiveness research. why does a treatment’s effectiveness differ from its efficacy? there are many reasons why the effects of a drug in everyday clinical practice are different from those seen in clinical trials. in short, the entire societal-medical context contributes to the effectiveness of a drug or intervention. before we look at some of the key factors, we need to remind ourselves that both “efficacy” and “effectiveness” are determined in groups of people and not individuals. while efficacy pertains to groups of participants in clinical trials, effectiveness pertains to all people with a disease who could be treated with the drug. issue 1: physical availability and accessibility above all else, to be effective, a drug needs to be available to patients, at best to all patients with the disease it was developed to treat. there are national, regional, and local aspects of availability of a treatment. approval of a drug by regulators permits its marketing and selling in a certain country. for example, a drug that is approved in the united states may not be available in canada or mexico. before the new drug reaches a patient, a number of obstacles in the supply chain need to be overcome. the first one is reimbursement, ie, the negotiation of price for the new drug with government agencies, insurance companies, and pharma wholesalers. discussions on price may have a drastic effect on availability. if a pharmaceutical company considers the proposed price too low to ever regain its investments, it may decide not to provide the drug at all. regional differences in availability may arise when regional pharma wholesale companies decide on stocking of medicines. they may decide not to stock a certain drug in certain locations because they do not believe that it will be widely used there. even if a drug is available via a wholesaler and the physician is willing to prescribe it, a patient’s health insurance plan may not cover the entire cost for the new treatment. likewise, if a patient is in hospital, she might not get the drug because the company that runs the hospital may not see its benefits and may therefore not include it in their treatment plans and offer an alternative treatment. furthermore, health care providers may not believe in the benefits of a certain drug and may prescribe treatments that they consider to have superior therapeutic effects instead. thomas m. schindler1 and helen bridge2 / 1innovation medical writing, boehringer ingelheim pharma, biberach a.d. riss, germany; 2medical communications, astrazeneca, cambridge, united kingdom statistically speaking the evaluation of effectiveness, or how do we know whether a treatment works in real life? part 2 amwa journal / v36 n1 / 2021 / amwa.org 35 issue 2: medical tradition medical doctors, ie, the prescribers of medicines, undergo many years of training, and they apply this knowledge in their clinical practice, thereby maintaining a certain medical tradition. such traditions are tenacious, and it may take a long time before new therapeutic options are widely accepted and offered to all patients. conversely, health care providers and hospitals may continue to offer treatments to their patients that have long been shown to be less effective because this is their established practice, offers financial advantages, or is expected by patients. medical practitioners follow the insights they gain in their medical practice. if they have the impression that a particular medicine works for their patients, they will continue to prescribe it. they will stick to what they believe is helpful and may not use a new drug with which they have little experience. this is particularly likely when a new drug has only been tested against placebo and not against established treatments. a new drug may not be given to a patient because the physician has not heard about it or does not believe it is superior to the drugs that she usually prescribes. issue 3: treatment adherence in clinical trials, participants are closely monitored with regard to how and when and at which dose they take their medication. for example, study participants are reminded to take their dose at the same time every day, with or without food, to achieve the optimal effect. in normal life, things tend to be different, and patients might occasionally forget to take their medication. on days when their disease is particularly discomforting, they may be inclined to increase the dose of their medicine. if their lives are busy, patients may forget to renew their prescription in time and may therefore not take any medication for a while. thus, although the drug is available to the patients, its effects may be smaller than those observed in the clinical studies because of limited adherence to medication plans. furthermore, patients might be taking additional drugs to treat other conditions, and these drugs may influence the effects of the new treatment. real-world data and real-world evidence to determine effectiveness many different factors affect the use of a drug in everyday medical practice. it is therefore very difficult to determine how effective a drug is “out there.” post-marketing (phase 4) studies usually focus on safety rather than effectiveness. however, for many stakeholders in the health care system, it is important to know how well a drug works in the real world: • patients taking the medicine want to know whether it works, • payers like health insurance companies need to understand whether they are paying for an effective treatment, • government agencies want to know how the new medicine affects public health, • pharmaceutical companies want to understand to what extent available medicines meet patients’ needs and whether there is space for additional medicines. recently, there has been much discussion about the usefulness of “real-world data” (rwd) and ”real-world evidence” (rwe) to evaluate effectiveness of treatments and support health care decisions. rwd and rwe are generally understood to refer to data and evidence from sources other than traditional clinical trials, but it has not always been clear exactly what these categories include. over a number of years, regulators were pressed to delineate ways to incorporate nonclassical data in their evaluations. in 2018, the us food and drug administration (fda) released the framework for the agency’s real-world evidence program. there, they give the following definitions: • rwd is “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.” • rwe is “the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of rwd.” real-world data: abundant, promising, but messy sources of rwd include registries, electronic health records, medical claims databases, mobile devices, and so on. the recent excitement about rwd and rwe has focused on the availability of apparently rich sources of data, particularly those resulting from digitization. sources such as electronic health records from entire health systems or wearable devices that generate data on a plethora of variables at frequent intervals promise an abundance of easily collected data. there is a growing tendency to believe that data collected in the course of routine health care, whether via the records kept by health care providers or directly from patients using apps, better reflect how treatments actually perform than data collected in the research settings of clinical trials. large quantities of rwd can easily be collected from thousands, or even millions, of patients, and such “big data” seem to promise greater representativeness than data from the comparatively small, selected populations of patients included in clinical trials. there are also clear practical and economic grounds for exploring rwd: vast quantities of such data can be collected and accessed quickly and cheaply by comparison with the laborious and costly collection of data in traditional clinical trials. rwd therefore holds appeal for companies keen to reduce the expense and time taken to bring treatments to market. statistically speaking 36 amwa journal / v36 n1 / 2021 / amwa.org easy and cost-effective access to large quantities of medical data collected from the full range of users of a treatment in real-world conditions may sound too good to be true. sure enough, there are several major obstacles to using rwd to reach reliable conclusions regarding the effectiveness of treatments. obstacle 1: data quality one of the factors behind the expense of running clinical trials is the quest for good data quality and the consequent rigor with which data are collected. the clinical trial protocol specifies precisely which data are to be collected for each patient, the time points at which they are to be collected, and the methods, often including the precise equipment, that are to be used. a trial is designed to answer specific scientific questions, and the data to be collected are those that are required to answer these questions. data are recorded on a case report form designed specifically for the trial. strict procedures are followed to ensure data are collected in accordance with good clinical practice principles, and clinical trial monitors verify the data for completeness and accuracy. these methods ensure that clinical trial data are highly standardized from patient to patient and from center to center, with the same variables measured and recorded in the same way and at the same time points. these provisions make clinical trial data reliable and trustworthy. data from real-world sources are unlikely to share any of these qualities. table 1 outlines the main problems with quality of rwd. these deficiencies introduce noise and bias that make it difficult to draw reliable conclusions about the effectiveness of a treatment. obstacle 2: lack of randomization medical research generally falls into 1 of 2 broad categories: clinical trials and observational studies (figure 1). the key feature that separates these approaches is the presence or absence of randomization. a recent opinion piece in the new england journal of medicine insightfully contrasts the “magic of randomization” in rcts with the “myth of real-world evidence” from observational studies. randomization ensures that there are no systematic differences between treatment groups with regard to patients’ characteristics that may affect efficacy outcomes. it is likely impossible to achieve such a balance in an observational study because the groups that are compared did not result from randomization. whenever the treatment is a choice, whether by a doctor or the patient, groups of patients taking different treatments are likely to differ systematically, often in ways that are difficult to identify. moreover, the reasons for the choice of a particular treatment are almost never entered into health records or databases. this is likely to result in a biased comparison of the treatments. indeed, there have been well-publicized cases in which observational studies and rcts have come to opposing conclusions about particular treatments. an obstacle to using rwd to evaluate effectiveness is that these data originate in routine health care contexts in which patients are not randomized to treatments. although such data have long been used by regulators to evaluate the safety of treatments, using them to arrive at unbiased evaluations of effectiveness is challenging and requires sophisticated considerations on methodology. in recent years, statisticians have worked on developing new study designs and complex analysis methods, including so-called “causal inference” and machine-learning methods, to help overcome some of the limitations of analyzing observational data. the fda has committed (in its rwe framework document) to evaluating “the potential role of observational studies in contributing to evidence of drug product effectiveness” and has supported a series of workshops that included discussion of methods for assessing and minimizing bias in observational studies. statistically speaking table 1. real-world data: common problems with data quality characteristic of data likely problems with rwd relevance to research questions data are collected for purposes other than research and will not be optimal for answering the question of interest. there is a risk of allowing the available data to determine the research questions that are asked (rather than defining the question first and then looking for the data). reliability inaccuracies in the data may result from human error or faulty devices. data collected cannot be verified by comparison with source data. random errors and systematic bias are difficult to identify and impossible to correct. completeness rwd are characterized by a high quantity of missing values, with no information as to why data are missing. consistency and interoperability variables recorded, measurement methods, and data formats and data standards usually vary greatly across patients, health care providers, devices, companies, etc. the lack of common data standards, ie, the way data are structured, stored, and summarized, makes it challenging to collate and analyze the data. amwa journal / v36 n1 / 2021 / amwa.org 37 obstacle 3: the need for rigorous research methodology no amount of data can, in itself, help us evaluate treatments. data only become evidence once they are used within a methodological framework or research study to answer specific questions, such as “is treatment x effective in patients with heart failure?” or “how much more effective is treatment a than treatment b at extending survival in patients with advanced non-small cell lung cancer?” for rwd to provide evidence of effectiveness, they need to be analyzed using an appropriate research methodology. this includes the definition of data formats for datasets, the availability of a comprehensive study protocol, and detailed analysis plans to ensure reproducibility of results. if data are derived from novel data sources such as wearables, these data need to accurately reflect the clinical outcome that is being investigated. combining clinical trials and real-world data for insight into effectiveness observational studies are not the only way of using rwd to tackle the question of effectiveness. a promising alternative approach advocated in the fda framework document as a way of generating rwe is to make clinical trials more “real life.” this can be done by simplifying the trial design to become a “large, simple trial” or by otherwise incorporating pragmatic elements in the design so that patients’ treatment within the trial closely resembles routine clinical practice (figure 1). alternatively, hybrid designs can be used whereby health data that are routinely collected are used in the trial, together with data specified by the trial protocol (for example, efficacy-to-effectiveness or efficacy-and-effectiveness-too trials). combining clinical trial methodology, notably randomization, with the collection and evaluation of rwd has the benefit of enabling a more unbiased evaluation of treatment effects in settings that are close to real-world clinical practice. particularly in rare diseases, it is often impossible to conduct rcts because of the low number of patients available. recruiting a sufficient number of patients into a study may take too long to yield useful results. in these instances, single-arm open-label studies may be conducted and the results compared with external controls, ie, rwd collected outside of the study. the control data could come from registries, medical records, scientific literature, or expanded access programs. a recent example of such an approach is the approval of avelumab in metastatic merkel cell carcinoma. the drug was approved in 2017 based on a single-arm open-label study that compared the study outcomes with historical controls retrieved from electronic health records. in 2019, approval of palbociclib for hr+, her2advanced breast cancer in men, a label extension, was based on post-marketing reports and electronic health records. responses to the coronavirus disease 2019 (covid-19) pandemic provide a further, highly topical example of how randomized trials that incorporate real-world elements can generate reliable evidence of effectiveness to guide clinical decision-making about treatments. at the time of writing, a number of large, simple trials to evaluate various potential figure 1. idealized theoretical framework for the generation of evidence for efficacy and effectiveness. hybrid trials are studies that combine efficacy and effectiveness assessments. e2e, efficacy-to-effectiveness trial (sequential assessment); ee2, efficacy-and-effectiveness-too trial (simultaneous assessment); ehr, electronic health records. statistically speaking continuity of evidence classic rct pragmatic trials large simple trials hybrid trials, e2e, ee2 data observed for research purpose electronic data, ehr, insurance claims, etc unstructured data efficacy randomized trials observational studies effectiveness ©tmschindler & hbridge 2021 38 amwa journal / v36 n1 / 2021 / amwa.org treatments for covid-19 are ongoing. for example, the global solidarity trial, initiated by the world health organization, had recruited over 12,000 patients by october 2, 2020, with 116 countries having joined or expressed an interest in joining the trial. in the united kingdom, the recovery trial is being conducted at all major hospitals and had enrolled over 20,000 patients by december 2020. these trials have simple protocols and heavily streamlined procedures. the aim is to maximize recruitment and minimize the burden of participation on health care staff. the recovery trial, for example, has minimal eligibility criteria, simple and quick informed consent and randomization processes, and minimal data collection requirements, with follow-up information to be recorded at a single time point. within 3 months of trial initiation, results were released showing the effectiveness of dexamethasone for reducing mortality in patients on mechanical ventilation or supplemental oxygen. the trial has also shown hydroxychloroquine, lopinavir and ritonavir, and azithromycin to be ineffective at reducing mortality from covid-19. these examples show the potential of combining rcts with rwd to produce robust evidence of effectiveness that can inform decision-making about treatments. they also indicate that the use of rwd, while informative as a supplement to rcts in certain contexts, is unlikely to replace traditional rcts. until a treatment is widely used in clinical practice, there are no rwd relating to its use. consequently, data to support firsttime marketing approvals for new drugs have to come from rcts. the context of a clinical trial also allows close monitoring of patients, which is essential for their safety with drugs that have not yet received marketing authorization. as the examples given show, the situation is very different when a new drug is to be compared with a widely used drug or when well-established drugs are to be evaluated as potential treatments for a new disease. author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. author contacts: thomas.schindler@boehringer-ingelheim.com; helen. bridge@astrazeneca.com resources baumfeld andre e, reynolds r, caubel p, azoulay l, dreyer na. trial designs using real-world data: the changing landscape of the regulatory approval process. pharmacoepidemiol drug saf. 2020;29(10):1201-1212. beaulieu-jones bk, finlayson sg, yuan w, et al. examining the use of real-world evidence in the regulatory process. clin pharmacol ther. 2020;107(4):843-852. collins r, bowman l, landray m, peto r. the magic of randomization versus the myth of real-world evidence. n engl j med. 2020;382(7):674-678. epstein d, propublica. when evidence says no, but doctors say yes. the atlantic website. published february 22, 2017. accessed january 8, 2021. https://www.theatlantic.com/health/archive/2017/02/when-evidence-saysno-but-doctors-say-yes/517368/ ford i, norrie j. pragmatic trials. n engl j med. 2016;375(5):454-463. franklin jm, schneeweiss s. when and how can real world data analyses substitute for randomized controlled trials? clin pharmacol ther. 2017;102(6):924-933. najafzadeh m, gagne jj, schneeweiss s. synergies from integrating randomized controlled trials and real-world data analyses. clin pharmacol ther. 2017;102(6):914-916. randomised evaluation of covid-19 therapy (recovery) clinical study protocol, v12.1. recovery trial website. published december 16, 2020. accessed january 8, 2021. https://www.recoverytrial.net/files/recoveryprotocol-v12-1-2020-12-16.pdf reynolds mw, bourke a, dreyer na. considerations when evaluating realworld data quality in the context of fitness for purpose. pharmacoepidemiol drug saf. 2020;29(10):1316-1318. saesen r, huys i. covid-19 clinical trials: see it big and keep it simple. bmj evid based med. published online july 8, 2020. doi:10.1136/bmjebm-2020111447 schindler tm, bridge h. the evaluation of efficacy, or how do we know whether a treatment works? part 1. amwa j. 2020;35(2):82-86. scott ia, attia j. cautionary tales in the interpretation of observational studies of effects of clinical interventions. intern med j. 2017;47(2):144-157. selker hp, eichler h-g, stockbridge nl, et al. efficacy and effectiveness too trials: clinical trial designs to generate evidence on efficacy and on effectiveness in wide practice. clin pharmacol ther. 2019;105(4):857-866. sherman re, anderson sa, dal pan gj, et al. real-world evidence – what is it and what can it tell us? new engl j med. 2016;375(23):2293-2297. world health organization. “solidarity” clinical trial for covid-19 treatments. published 2020. accessed january 8, 2021. https://www.who.int/ emergencies/diseases/novel-coronavirus-2019/global-research-on-novelcoronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments us food and drug administration. framework for fda’s real-world evidence program. published december 2018. accessed january 8, 2021. https://www. fda.gov/media/120060/download wapner j. how prescription drugs get their prices, explained. newsweek website. published april 14, 2017. accessed january 8, 2021. https:// www.newsweek.com/2017/04/14/prescription-drug-pricing-569444. html#:~:text=reimbursement%20is%20the%20amount%20the,as%20a%20 pharmacy%20benefit%20manager statistically speaking mailto:thomas.schindler@boehringer-ingelheim.com mailto:bridge@astrazeneca.com https://www.theatlantic.com/health/archive/2017/02/when-evidence-says-no-but-doctors-say-yes/517368/ https://www.theatlantic.com/health/archive/2017/02/when-evidence-says-no-but-doctors-say-yes/517368/ https://www.theatlantic.com/health/archive/2017/02/when-evidence-says-no-but-doctors-say-yes/517368/ https://www.recoverytrial.net/files/recovery-protocol-v12-1-2020-12-16.pdf https://www.recoverytrial.net/files/recovery-protocol-v12-1-2020-12-16.pdf https://www.recoverytrial.net/files/recovery-protocol-v12-1-2020-12-16.pdf https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments https://www.fda.gov/media/120060/download https://www.newsweek.com/2017/04/14/prescription-drug-pricing-569444 https://www.newsweek.com/2017/04/14/prescription-drug-pricing-569444.html#:~:text=reimbursement%20is%20the%20amount%20the,as%20a%20pharmacy%20benefit%20manager https://ebm.bmj.com/content/early/2020/07/08/bmjebm-2020-111447 amwajournal.org 15session reports look for author instructions on the journal’s home page, which may be in a tab near the top or a link along the side or near the bottom of the page. note that submission instructions are usually different from author instructions. submission instructions include the platform for uploading your manuscript files, any publication fees, and other relevant information. common features of manuscripts schrank toured the common features of modern manuscripts, showing both organization and what information goes where. journals do vary in placement for some information; here are common things to check: • information required on title page • specific subheadings for abstracts • acknowledgements section—thank contributors (eg, statisticians, medical writers) • source(s) of funding • conflicts of interest—sometimes duplicated dummy submissions allow editors to discover what the journal requires if the target journal is known, start a dummy submission in the online portal using the login id and password of the submitting author. gathering all information and materials from your authors ahead of time will avoid delays when it is time to submit the manuscript. once you start the dummy submission, read the instruction prompts carefully for any surprises (eg, a cover letter is required and authors have not written one). common information requested on submission: • email addresses for all authors • biography of each author • suggested peer reviewers and email addresses; some journals require it and want up to 3 names • conflicts of interest/wording of statement for no conflicts • open access fees (do authors know this and want to pay for it?) • summary box/key messages of the research once the manuscript is submitted, it will follow 1 of 3 paths (table), and some authors will also engage the editor in this phase. christine holzmueller is a senior technical writer at the johns hopkins university armstrong institute for patient safety and quality in baltimore, maryland. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: cholzmu@gmail.com reference 1. gawande a. the checklist manifesto: how to get things right. metropolitan books; 2009. * * * where data, design, and technology meet: effective infographic strategies for health communication speaker kathleen walker, content strategist, communicate health, fort worth, tx by sunali wadehra, md what is an infographic, and why are they important? an infographic is a graphic visual representation of information, data, or knowledge that is intended to present complex information quickly and clearly. slick graphics and data visualization are used to engage the audience, and visual storytelling is used to convey a concept. a well-designed infographic helps people find what they need, understand what they find, and remember what they read. note that not just any chart or graph qualifies as an infographic; it must represent this criterion. table. three paths of a manuscript path role of the editor accepted read the article proofs carefully for issues introduced by the journal editors (eg, typos) and for behind-thescenes comments that should have been removed respond to queries/comments addressed to the authors deter authors from requesting new revisions, as this could be costly (if it is allowed) revise and resubmit ensure response letter is polite; thank the reviewers for suggestions (even if slightly off base) help author pick the important battles; yield to suggestions and points when ethically possible ensure that the revision is better, not worse, than the original text explain to the reviewer what was changed and why follow instructions for how the editor wants to see changes to the manuscript (eg, track changes visible, detailed cover letter) rejected submit to another journal rework manuscript then submit elsewhere http://www.amwajournal.org amwajournal.org 16session reports what is the value of an infographic? likely, they can reach and engage audiences in a way that health information becomes easier to understand than another media. an infographic is 30 times1 more likely to be read than a text article because users are more likely to engage with content that is presented visually. in addition, people following directions with text and illustrations do 323%1 better than people following directions without illustrations, so infographics are particularly effective in conveying information that requires users to act. in addition, infographics stand out from the crowd, are easy to share, and may be more cost-effective than other media. an infographic may be used to present statistical data, provide how-to guides, describe processes, illustrate timelines, map trends, make comparisons, and organize facts. note that how-to guides are especially valuable for low literacy populations, as visual elements can help facilitate their understanding. this approach is particularly effective when you test them on audiences to make sure the infographic conveys the right takeaways. did you know that infographics may facilitate health literacy? did you know that about 9 in 10 people have limited health literacy? they too should be able to access health information, and infographics help to facilitate that. the best practices for creating infographics are aligned with several key health literacy principles. what are some examples of these principles? • state the main message up front. • use common, familiar words. • use “1 in x” language. (eg, “1 in 5”) other recommendations specific to using infographics to promote health literacy include aiming for minimal text and using key messages, using images as cues to support understanding, and providing visual representations to help learners understand the meaning of data. more strategies, tips, and tricks writers and designers are key players in creating content and developing infographics. those involved in the content development process—which should happen before the design process—should try to identify opportunities for the designer, whilst being open to their approaches. even content designers sketch their visions out for the infographic. however, everyone else involved in the process should also understand its nuts and bolts to facilitate collaboration and communication. here are 10 strategies for optimizing infographics: 1. start with an audience and a message. this helps to hone in on the “why” and “how.” more specifically, determine your audience, objective, goals, and method of distribution. 2. find data. for example, data can be gleaned from internal, government, academic, and/or research resources. note that it is okay to start with more data than needed and pare down during the development process. 3. write a story—meaningfully. what is the story that needs to be told? how can that story be supported with data? is there a hero statistic that can be featured? a few strong pieces of data to back the story up can be advantageous, with the hero statistic acting as a single takeaway piece of data that is the centerpiece of the story. 4. look for visual opportunities. evaluate the content and consider how the story can be conveyed through visualizations, including data that can be designed or content that can be reinforced with an icon. also, use positive visualization when possible. for example, when designing an infographic about outdoor air quality, consider presenting someone exercising indoors. 5. be creative. consider questions such as, “can i add an accompanying visual here?” “does this deserve an icon?” “how can this data be displayed?” 6. choose meaningful design elements, including colors and fonts. even these elements should be strategic. for example, color palettes that include red can reinforce a message of danger. 7. keep it simple. a major problem noted with many infographics is a design that fits too much content. minimal content is the way to go, and visual elements should be the star. 8. organize and group content in logical ways. content should be split into clear, digestible chunks. note that even 1 page of draft content in microsoft word can at times be too much for an infographic. 9. create a clear visual hierarchy. this may guide the learner through the desired order of what should be read first, next, and last. because many individuals tend to tackle visual information in chunks, they are likely to view this information in a sequence of how important it seems. 10. design for clarity and readability. make use of white and negative space to allow content to breathe, use appropriate and readable (sans serif ) fonts, build with a grid in mind, and avoid styles that make content or imagery difficult to interpret. http://www.amwajournal.org amwajournal.org 17session reports conclusion this session covered what infographics are, why they are used, when they are used, and when they shouldn’t be used. in general, they may help you identify your audience and goals, communicate data and other health information, reinforce your message visually, educate across barriers, create awareness, and encourage action. sunali wadehra is a freelance medical writer at wadehra medical writing, llc, in st. louis, mo. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: sunali@wadehramedicalwriting.com reference 1. cox lk. why are infographics so darn effective? [infographic]. hubspot website. updated july 28, 2017. accessed october 2021. https://blog.hubspot.com/marketing/effectiveness-infographics# sm.0001lqkcekbcccr810862dx9nrvhr * * * the importance of data presentation speaker barry drees, phd, senior partner, trilogy writing & consulting gmbh, frankfurt, germany by sampoorna rappaz, phd the effectiveness of medical communication hinges on both the text and the accompanying data presentation being fit-for-purpose. dr barry drees, in his presentation at amwa’s 2021 medical writing & communication conference, explained how we can fulfill the ultimate purpose of data presentation, which is to tell a story clearly and simply. using examples from the domain of regulatory writing, scientific communication, and medical and world history, he illustrated how good data presentation can help focus the message, correct misperceptions, and even save lives! when done well, each element of data presentation within a document communicates 1 main message, which is determined by the question that the data are answering. identifying this question and the message will help us decide how to best represent the data (figure). distinct data presentation types exist, each suited to a unique purpose. once we have made a choice, we can use logical design principles to highlight and clarify the message. design considerations for tables dr drees has the following advice for creating tables: resource list for inspiration • designspiration.com • good.is/infographics • dailyinfographic.com • abdz.do for design assistance • infogr.am • piktochart.com • easel.ly • visual.ly figure. how to determine the right data presentation type. the purpose and message of the data presentation and the type of data variable will direct our choice. http://www.amwajournal.org https://blog.hubspot.com/marketing/effectiveness-infographics#sm.0001lqkcekbcccr810862dx9nrvhr https://blog.hubspot.com/marketing/effectiveness-infographics#sm.0001lqkcekbcccr810862dx9nrvhr https://blog.hubspot.com/marketing/effectiveness-infographics#sm.0001lqkcekbcccr810862dx9nrvhr http://designspiration.com http://good.is/infographics http://dailyinfographic.com https://abduzeedo.com/ https://infogram.com/ https://piktochart.com/ https://easel.ly/ https://visual.ly/product/infographic-design amwa journal / v36 n1 / 2021 / amwa.org 39 as medical writers, you’ve undoubtedly experienced the need for leadership in your writing projects. have you been conflicted as to how to best establish leadership despite having no clear authority over team members? how can we motivate teams to accomplish medical writing goals and help deliver quality documents? how can we do this in a proactive, efficient, and streamlined way? behind the scenes, we steer discussions, coordinate reviews, manage timelines, facilitate consensus, and harmonize global teams, all while writing the document at hand. leadership is an integral part of our medical writing lives. imagine the following scenario: debbie sits at her desk, a partially finished document on her monitor. fingers on her keyboard, she hesitates, but not for loss for words. she knows how to write the report but faces a quandary that affects all medical writers: she is missing some team comments yet is tasked with meeting the timelines. the last conference call did not resolve as much as hoped and left her with no clear direction. additionally, the data have been updated again. in this familiar scenario, leadership and efficiency are needed, and sometimes the best option is … you. in this article, we offer solutions to several scenarios like debbie’s that are applicable to contract, in-house, and freelance medical writers alike. we share experiences from seasoned medical writers compiled through informal surveys and discussions with our peers and collectively provide real world ideas on how to lead without authority, exercise diplomacy to your advantage, and provide insight on time management and personal efficiency. we provide guidance on how you can implement these strategies and takeaways into your everyday practice, including being able to identify project-, team-, and time-management solutions that will help you grow as a medical writer and exercise positive and effective influence within your medical writing projects. leading without authority leading without authority takes courage to establish yourself as a knowledgeable leader, not only from a writing standpoint but also in understanding all aspects of developing and completing medical writing projects. this approach also takes work in understanding disease states, indications, document-management processes, standard operating procedures, and templates, as well as the guidance and regulations that drive our industry. last, leading without authority requires empathy in order to put yourself in your team members’ shoes and understand what is driving their decisions, all while being committed to the quality and realistic management of the document. scenario 1 debbie just sent out the third version of “draft 1” for team review. she receives an email that the team has changed directions (again). debbie is asked to abandon the third draft, return to the first draft (with some content from the third draft), and provide a new fourth draft in the next 2 to 3 days. what action should she take? although frustrated, debbie knows the document is connected to a corporate goal. she also realizes it’s a good time to take a quick break to relax and do something she enjoys. returning to her desk, she checks her availability and contacts her supervisor about this unanticipated draft. asking for support may be her best option, rather than taking everything on herself. debbie can • put a meeting on the calendar with the authoring team to discuss any questions she may have regarding this new direction. katie bates, phd; dwyn desilver, bs; cathi harmon, bs / whitsell innovations, inc, chapel hill, nc leadership behind the scenes: a backstage approach to effective medical writing practical matters *this article was presented in part as a poster at the amwa 2019 medical writing & communication conference. 40 amwa journal / v36 n1 / 2021 / amwa.org • check to ensure she understands the agreement for the number of drafts and the timelines. • recommend writing that can be done by a team member or another medical writer. • ask for more writing time, when appropriate, or a reduction in team review times. scenario 2 debbie is excited that a project is finally going through approval. she unexpectedly receives an email from team management questioning the document’s accuracy and expressing surprise at the 1 day approval turnaround. what good options does she have? this individual reviewed the document a week before; however, debbie knows the document must be approved by this individual. although taken aback at this turn, debbie understands this person reviews many items per day, manages 6 people, and attends numerous meetings. does she remember last week? debbie realizes that clarifying the issue is the best option. debbie can • take a step back to consider her approach to the situation rather than sending a premature email. • use empathic, fact-based language, such as: –“your statistician was an integral part in reviewing and confirming the data analysis in the document; her input has been invaluable.” – “my apologies; it was my understanding that you had previously reviewed the document and the approval step is typically only a formal step to approve the document in the system.” • include in her response that she is available by phone to discuss further, if needed. • inform the entire team that document approval may be delayed and provide a revised timeline if appropriate. to be successful in leading without authority, as the medical writer, you need to be prepared, be kind but firm, and know your stuff. understand what is potentially driving the behavior (eg, corporate goals, being caught out of the loop) but stay committed to the quality and realistic management of the document. use empathic language to soften the defensive nature of a person, as this approach would allow your audience to remain open to the facts you are presenting. it’s not about being right or wrong. it’s about building a successful relationship and demonstrating your value to the team. team diplomacy team diplomacy involves seeking to gain the perspective of your team members and navigating conflicting opinions in such a way that everyone is pleased with the outcome. being a diplomatic leader requires building trust and gaining respect, being willing to listen, communicating rather than dictating, and using questions to solicit ideas. scenario 3 debbie is waiting on comments from the last team member. time is running out, and she suspects that the response may come later than expected. what good options does she have? although not ideal, if the team member is not a primary reviewer, it may be possible to proceed without those comments. knowing her team member’s role is critical to this option. during the kick-off meeting or initial interactions with the team, debbie should clarify the hierarchy and roles within the team. if this team member’s comments are essential, it may be necessary for debbie to accommodate late comments. it is important that debbie be mindful of work/life balance, however, while ensuring the document moves forward. she could • call the reviewer to better understand when the comments will arrive. this not only ensures the reviewer is aware of the importance of their input but also will help debbie to plan accordingly. • send another email but carbon copy someone that the team member is accountable to or respects. • draft the email and include language regarding the updates that only requires confirmation from the reviewer. this is frequently more straightforward than asking for revised text directly. • reiterate timelines and the urgent need for their response in addition to the consequences of a missed deadline. • be persistent; ask more than once. to be successful in leading without authority, as the medical writer, you need to be prepared, be kind but firm, and know your stuff. practical matters amwa journal / v36 n1 / 2021 / amwa.org 41 practical matters scenario 4 debbie is not getting the answers she needs at comment resolution meetings. there is significant dissent among team members, with no resolution in sight. furthermore, the team frequently reverses their decisions after the meetings. is there hope? to try to resolve this issue, debbie could • ensure that the project stakeholders attend the commentresolution meetings to address unresolved issues. this requires that debbie understands the team dynamic. • break down multiple comments to an overarching comment or question to help focus the team to a more concise discussion. • ask the question, “does the team agree?” as a means to prevent unnecessary discussion. • take the discussion offline with the key team members. occasionally, it may be helpful to request that key team members discuss internally with one individual assigned to inform debbie of any decisions. • be sensitive to cultural differences. some team members may not directly contradict a team member in a meeting but may share information more readily with debbie privately. credibility is built on effective communication with your team. whether you need to “tease out” comments from a reviewer or obtain team consensus, thinking creatively about how to best communicate and build rapport with individual team members while maintaining your boundaries is necessary to ensure your effectiveness. personal efficiency time management and personal efficiency are on everyone’s mind, with buzz words like “productivity hacks” all over the internet. in our world, carving out these efficiencies is essential for our medical writing work, because time translates into money. this can take the form of targeted best practices for document management to understand and capitalize on personal preferences, work habits, and discipline. scenario 5 debbie receives unconsolidated review comments from the team, at different times and in different formats, and some are past the deadline. what is the most efficient approach for debbie to deal with this? debbie can • understand the make-up of the team and their individual level of contribution to the progress of the document. • triage incoming comments by complexity and priority— work on those requiring follow-up first, which allows progress while simpler comments are reconciled and incorporated. • keep a master document. as comments are triaged, incorporate revisions likely to be essential, and make notes of those that need team confirmation. • mark text or comments to be discussed with the team with an easily searchable symbol (eg, $$). • leave global changes until the end, keeping an ongoing list of global changes within the document to make after other comments are reconciled. • send relevant sections of the document (with specific questions and instructions) to targeted reviewers for quick and critical input. • maintain version control—this is essential. devise a naming convention that captures the chronology and source of comments. • communicate! one set of consolidated comments for each draft is typically expected. • proactively assess the effect on timelines and anticipate delays. scenario 6 debbie contemplates how to proceed given missing review comments for her clinical study report and an unexpected data update. other project timelines have now overlapped because of delays. does she have too many balls in the air? debbie must • get organized with a spreadsheet across all projects—this is worth the time investment. • reel in the chaos by prioritizing what she can do and identifying where she might need help. • delegate! it is essential, however, to provide appropriate training to anyone helping out, with thorough instructions and realistic expectations. • parse out blocks of time to work uninterruptedly on one task—darting back and forth is less efficient. specific goals for these blocks of time is helpful. • eliminate distractions—debbie can respond to urgent emails at designated times, then turn off her email and phone. • capitalize on when she works best and stick to it—this is important. • remind contributors of the consequences of continued delays for critical path issues. • ask for a summary of changes for data updates to help focus revisions. • take advantage of collective insight through amwa online resources and the engage forum. she is not alone! 42 amwa journal / v36 n1 / 2021 / amwa.org leadership qualities such as being proactive and confident can make a world of difference in how you approach challenging tasks and situations. this can translate into time savings and efficiency in all aspects of a medical writing project. from knowing how to anticipate when you need help to interacting with difficult team members who are unable to review in a timely manner, confidence can ultimately help you get the job done. conclusion being a medical writer is a wonderfully rewarding career and always keeps you on your toes. every team and project are different, not to mention the constant change that goes with writing drug and device documents. asserting behind-the-scenes leadership is often critical to the successful conclusion of a writing project, which in turn builds your team’s confidence in you as a writer and valued team member. being able to communicate effectively and diplomatically is essential in developing successful relationships with your teams. although this profession can be demanding at times, developing strategies that make you more efficient is key. in the end, sometimes the best option is how you personally approach each challenge. sometimes the best option is you! author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. author contacts: katie.bates@whitsellinnovations.com, dwyn.desilver@ whitsellinnovations.com, cathi.harmon@whitsellinnovations.com join our growing team. we’re looking for freelance and full-time regulatory and medical writers who get it done right. for full-time positions, please visit https://www.certara.com/ company/careers. want to remain freelance? send your cv to careers@certara.com with “freelance writer” in the subject line. as certara’s regulatory science division, synchrogenix assures and accelerates the approval of medical innovations world-wide. certara is an equal opportunity employer. certara does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. all employment is decided on the basis of qualifications, merit, and business need. the right candidates can be lead authors on: • clinical regulatory documents clinical study reports, protocols, integrated summary of safety, integrated summary of efficacy, clinical overviews, investigator brochures • nonclinical documents sections 2.4 and 2.6 of the ctd, toxicology and pharmacology reports • submissions inds, ndas, andas, 510k as well as gap analysis and remediation reports • medical publications manuscripts, abstracts, congresses, slide deck mailto:katie.bates@whitsellinnovations.com mailto:cathi.harmon@whitsellinnovations.com https://www.certara.com/company/careers mailto:careers@certara.com mailto:dwyn.desilver@whitsellinnovations.com https://www.smashwords.com/books/view/1003520 amwa journal / v36 n1 / 2021 / amwa.org 7 awards conference coverage2020 amwa medical writing & communication conference dates: tbd location: online trends and opportunities for medical communicators hi, everybody. when i was first contacted by the american medical writers association way back on february 18th and informed that i was the recipient of this year’s walter c. alvarez award, i was so excited and honored and surprised and immediately eager for the day when we could all be together. i ended my email, in fact, by saying ,“i can’t wait to see you.” it is very bittersweet to be with you today in this format, in my bedroom. again, still, where i have spent so much time over the past several months looking at these 4 walls and that pile of laundry, right over there, that i will get to later. i have changed. and i’m sure that you have changed as well. we’ve changed in ways that are unique to every single one of us and we have changed collectively. some of those changes have revealed themselves very slowly over time and some of them have been quite abrupt. i happen to know about both of those things, and so i thought maybe we could spend a little time today talking about that. talking about those moments that define us and who we are. the ones that we see ourselves in terms of the before and the aftermath of. that first kiss, the loss of a parent, the birth of a child, an act of violence, a report on the news, a phone ringing in the middle of the night, or ringing in the middle of the morning. i’m going to tell you about the phone call that changed my life. this, as we say at the beginning of every comedy movie from the last 25 years or so, is me. just a normal person on a summer day, maybe a little bit of an overachiever, maybe a little bit of a type a, because what good comedy doesn’t start with someone like that? taking my first and what turned out to be my last trapeze lesson. this is me, less than a week later, on another summer day. i don’t think that i look very different, certainly not to a casual observer, although i see the changes. i see my older daughter, age 10, happy to have a day out, but i wonder what she was thinking. and i see my younger one, age 6, with her arms around me, and holding me protectively. and me holding her. i’m wearing a brand-new hat. it’s ridiculous, and i don’t like hats. i see something inscrutable in my face because i look at the camera and i know that this might be my last summer. let me take you back a few days. it was 10:30 in the morning, august 11th. i was on a deadline for a story and it was my dermatologist. i had been in her office a week before to have her look at a weird scab on my head. i had not been worried about it at all. the first thing she said to me was “i’m so sorry.” so, i grabbed a piece of paper and i started writing. malignant melanoma, underlined. meet with and then, nothing, because i think she said the doctor’s name too quickly. lymph node biopsy. i didn’t really know at that point what lymph nodes are. i’m still a little unclear. i do, however, know that i am very ticklish when my lymph nodes are checked. mary elizabeth williams / journalist and author, a series of catastrophes and miracles: a true story of love, science, and cancer every person is a patient: finding the story in the science the walter c. alvarez award is named in honor of walter c. alvarez, md, a pioneer in the field of medical communication. the award is presented to either a member or nonmember of the american medical writers association (amwa) to honor excellence in communicating health care developments and concepts to the public. the alvarez award is presented during amwa’s medical writing & communication conference. walter c. alvarez award address hello, this is your life now. 8 amwa journal / v36 n1 / 2021 / amwa.org oncology, that is a word i do know, so i underlined it. set up surgery. see if it’s in the lymph nodes. to my everlasting shame i wrote it’s without the contraction, and that is very unlike me. lymph i underlined again, will, underlined, do chest x-ray. consultation, physical exam. at the end of that phone call, i was someone else. i was a patient. the following day, i met my brand-new oncologist because i was a person with an oncologist. and a few days after that, i had surgery. i had a couple of centimeters taken off the top of my head and with it the hair. i ever since have had a big old bald spot on the top of my head, and i have learned a lot about combovers. as you can see from this photograph, i also learned that if i thought my other hat was ridiculous, i was entering a whole new world of ridiculous hats. i recovered. i found out that people have a lot of opinions when you get sick. some of them are very helpful, some of them are not. and i began yet another new life, this time, as a “cancer survivor.” this was my life for a while. three months to the day after i was diagnosed with cancer, my best friend was diagnosed with ovarian cancer. my father-in-law died of colon cancer. i went to the rocky mountains with a friend. i went to orlando with my family, and we saw hogwarts and drank butter beer and things were good, for a time. so record scratch, a year after my first diagnosis, i was diagnosed again. there had been some troubling spots in my lungs. i didn’t know that when i went in for my surgery that i already had a presumptive diagnosis of stage iv. i didn’t know that diagnosis carried a presumed 7 more months to live or that my odds of surviving 5 years were well below 10%. it was the beginning of the school year, and the likelihood that i was going to be around for the end of it was very slim. but i hit the jackpot. i became one of the first people in the world in a clinical trial for immunotherapy. i was one of the first 10. i became one of the first people in that trial to present no evidence of disease. and yet, when i look at my informed-consent form, i see how little i understood. i understood maybe the word melanoma in that form. and as you can see, i put a question mark next to everything else. that is unfortunate. it is unfortunate that the phrase informed consent rarely delivers on the first part, and then by consequence, it’s very hard to get the second part. and i wish that that was different. and i believe that it can be, because we need to live in a world where information is clear, and consent is truly authentically possible. i spent 2 years in my clinical trial. i spent a lot of time at the hospital. at one point, i had a nurse tell me she had never taken that much blood out of one person in a single draw. and i was doing all of this while i was still working and parenting and living my life. because that’s how it is. the experience of illness and treatment happens in our lives and our world. it does not occur on some separate plane in some other planet. and we are all seeing that in a very real way right now. we have to have context for our conditions because they are not discreet, and they don’t take place in a bubble. these photographs were taken about 2 weeks apart. [editor’s note: faces of two children in the photo on the right were blurred for privacy reasons] you can probably guess the time of year. i took my daughters to meet santa claus and they asked me to come with them. i was really feeling the effects of my treatment at this point. it was pretty hard. and i was very tired. and my girls whispered something to santa claus, and when i asked my older daughter what they said, she told me, “i can’t tell you or it won’t come true.” and then a little while later, my family and i were with our cancer support group, and my phone rang, and it was my doctor. i had had my first set of scans that morning, and he told i hate sequels. amwa journal / v36 n1 / 2021 / amwa.org 9 me that i presented no evidence of disease. and i asked him, “now what does that mean?” and then he explained it to me, and then i cried. and i went downstairs, and i told my daughters. they were in the midst of a birthday celebration. it was one of the happiest moments in, i think, all of our lives. and i took that photograph. that’s the moment that my daughters learned that their mom was going to be around. and very shortly after that photograph was taken, the moms of the other 2 kids in that photograph died of cancer. i have now been cancer-free for 8 years, but i am always a patient. and sometimes that is a real badge of honor, and sometimes i wish that people could see me as more than just a patient. my doctor and i used to do a guest lecture at a translational medicine class at a prestigious medical school every spring. and every spring, the physician who taught it would introduce my doctor by listing all of his achievements and experience, and then he would turn to me and say, “and a patient.” i don’t think he ever bothered to learn my name. i don’t think he ever saw me as a human being with a story to tell. with an experience that informed the process of research. i think he saw me as cells on a slide. but i’m very fortunate because he was an exception. which brings us almost to the present. i took this picture in madison, wisconsin. i was on a work trip and i stopped in for lunch before my flight home. it was the last time i was in a bar. it was the last time i had a conversation with strangers sitting next to me. there were 2 coworkers who came in from across the street for their lunch break and started talking. i had the grilled cheese with caramelized onions and fig jam. and a beer. and if i had known that i would not be doing this again for a very long time, i would have had dessert. it was the last time i was on an airplane. my life and the world have been very different ever since. and when i look at that photograph of a bunch of taps, i see something that is part of a health care story that is part of the story of 2020 and the pandemic that changed everything. i think i got a little bit spoiled being in a clinical research trial. on the one hand, yeah, i was a medical experiment, and i didn’t know if i was going to live or die and i didn’t know if the treatment itself might kill me, but on the other hand, i got to be part of the process. i got to be a reporter, which is completely in my wheelhouse. i worked with a team of doctors and nurses and researchers who for the most part respected me and listened to me. i was a collaborator. and an active voice in what eventually became the story of a treatment that has gone on to change how we look at cancer and has radically altered countless lives, not just for patients, but for their parents, their children, their spouses, their colleagues, their students. it’s amazing. and it is truly one of the most epic things that ever happened to me. it also taught me that that is how it should be. i want to make it clear that i am not some facebook mom who thinks that googling makes me more educated than my doctors. what i am, though, is someone who has experienced what we all have in life, and particularly over the past few months, someone who knows that the medical world is the world that we live in. that health care is not a place or a single experience or procedure. sickness, wellness, maintenance, chronic illness, mental health—they take place everywhere, all the time. all day long. in the absolute thick of our work and our parenting and going to school and taking care of our aging parents and financial insecurity and loneliness and love and fear and hope. i always bristle when i hear the phrase “clinical trial subject.” because it implies that i was simply an object of study. and i was. but i was not just that. being in that trial took effort. being a patient takes effort. walking around in a body every day takes effort. that is why i prefer the word “participant.” and right now, we are all participants. there is not a person in the world who doesn’t know what it is like to be slingshot into a health care crisis. there isn’t a single person who hasn’t seen the profound inequities that we face, the challenges that are unique to the most vulnerable among us, and who has not seen and depended on in a new way the underappreciated and often invisible work of the people who truly keep this world running. we need to be sensitive to that. we need to listen to that. we need to learn from that. we need to learn from each other. i’m so deeply honored and moved to be here with you, albeit virtually, in my bedroom. to be among people who have dedicated their careers to medical communication. i’m so impressed with you. i am so impressed with everything that you are doing to make sure that the science is translated accurately and clearly, especially right now in an age where there is so much misinformation competing for our attention. and it is a very confusing and disruptive time. 10 amwa journal / v36 n1 / 2021 / amwa.org lately, i have been studying in the field of medical humanities, and i have really been so edified to see that health care and humanities actually don’t have to be in competition with each other. that we can hold the dialectic and that concepts like critical thinking and listening and simple language are essential to the process. i know that humanities aren’t as sexy as data, but they are not decorative. they are essential for our survival. i have a friend who is a researcher, and at the beginning of this, i called him, and i said, “talk me down.” and he said, “we’re going to get through this. it’s going to be a mess. but we’re going to get through this.” i spoke to him again recently and i said, “i need a pep talk,” and he told me about how over the past few months, even when spikes have been happening in different places and even when the news has been particularly grim, what he has seen have been the ways in which people have been adapting. the ways in which doctors and health care workers have been learning and the ways in which we all have been learning. we are all participating in the process of making a healthier and better world, every single one of us. and we’re all learning from each other. we’re learning what works. we’re learning how to improve the system of communication and of care. and that is what gives me hope in all of this. and that is not just about data. it is looking at people in context. looking at the messiness and the imperfection of our lives. the pile of laundry i believe i have mentioned. i hope that context gives a deep well of information and richness to diagnosis and treatment. when we see not just disease, but we see the people affected by it. when we see the circumstances. when we see—what better example than when we see preexisting conditions and we see the impact that they have on health care? health care is not isolated. we are all our circumstances. we are all our stories. we’re all patients. we’re all participants. we’re all people, first and foremost. the only way through this is together. and the only way through this, as ever, is just by listening. so, thank you for listening to me today. thank you for this award. thank you for everything you do. i am so deeply appreciative. acknowledgment i thank elise eller, phd, medical writer and consultant, whitsell innovations, inc, for her help in bringing the transcript to the page. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. learn more amwa member resource library over 200 resources specific to your career as a medical communicator www.amwa.org/resource_library contents v37 n2 summer 2022 3 4 9 14 19 21 25 30 from the editor & guest editor communicating science � michael g. baker and thomas m. schindler theme articles generating plain language summaries of scientific publications with ethical foundations: a practical “how-to” guide cocreated with patients � thomas m. schindler the making of the good lay summary practice guidance: a multi-stakeholder document that was adopted into regulation – an interview with dr ingrid klingmann � thomas m. schindler 2021 conference session reports • a systematic approach to manuscript editing • where data, design, and technology meet: effective infographic strategies for health communication • the importance of data presentation practical matters writing your paper from the middle � hertzel c. gerstein, diana sherifali, and imran satia freelance focus jam session for seasoned freelancers—part 1 � brian bass, with commentary from melissa l. bogen, lori de milto, cathryn d. evans, gail v. flores, and phyllis minick in the service of good writing what's in a name? (diagnosis) � laurie endicott thomas, ma, els editor-at-large a shoe in the door: regulatory writing internships for promoting diversity and building the talent pool � jordan e. sedlacek and jeanette m. towles 48 36 detailoriented organized/ disciplined creates and maintains plans or timelines identifies tools and processes to gain efficiency perceptive intuits where in the team lifecycle he/she is producing a document finds creative solutions to related challenges proactive outlines team vision for document analyzes project plan and identifies risks and mitigations curious keeps up to date with latest regulations and standards builds therapeutic or regulatory knowledge base for team flexible gives flexibility when possible communicative communicates firmly when flexibility not possible collaborative builds relationships with other departments forges alignment advocates te ch ni ca l s ki ll so ft sk ill (e i) 30 editor-in-chief michael g. baker, phd managing editor rachel mosher, ma guest editor thomas m. schindler, phd section editors progress in publications qing zhou, phd, els regulatory insights jennifer bridgers, ms, mwc science series paul c. dolber, phd social media jennifer minarcik, ms statistically speaking thomas m. schindler, phd everyday ethics julie ravo, ba, ma freelance focus ruwaida vakil, msc technology talk kate mckiernan, ma, els regular contributors freelance focus brian bass, mwc melissa l. bogen, els sherri bowen, ma, els lori de milto, mj cathryn d. evans gail v. flores, phd phyllis minick in the service of good writing laurie endicott thomas, ma, els editor at large haifa kassis, md editors in memoriam lori l. alexander, mtpw, els, mwc ronald j. sanchez 2021–2022 president katrina r. burton, bs 2021–2022 board liaison r. michelle sauer gehring, phd, els 2021–2022 staff liaison shari rager, ms, cae executive director susan krug, ms, cae graphic designer amy boches, biographics editorial office: managingeditor@amwa.org. instructions for authors available at: www.amwajournal.org. advertising: contact marketing@amwa.org or (240) 239-0940. all advertising is subject to acceptance by amwa and should be for products and services relevant to professional medical communicators. amwa is not responsible for the content of advertising and does not endorse any advertiser or its products or services. subscription: the amwa journal is published quarterly. subscription is included with amwa membership. nonmember subscriptions cost is $75 per year. contact: american medical writers association, 30 west gude drive, #525, rockville, md 20850-4347. phone: (240) 238-0940; fax: (301) 294-9006; email: amwa@amwa.org. the amwa journal is in the mla international bibliography and selectively indexed in the cumulative index to nursing and allied health literature (cinahl) print index and the cinahl database. the opinions expressed by authors contributing to the journal do not necessarily reflect the opinions of amwa or the institutions with which the authors are affiliated. the association accepts no responsibility for the opinions expressed by contributors to the journal. ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwa journal mission statement in support of the mission of the american medical writers association (amwa) and to advance the broader profession, the amwa journal publishes content that reflects the interests, concerns, and expertise of medical communicators. its purpose is to inform, inspire, and motivate medical communicators. m o re v37 n2 / 2022 36 biography maud mellish-wilson – librarian, editor, visionary � tom lang 41 amwa news from the president � katrina r. burton annual financial report, 2020-2021 � julie phelan 2021 annual business meeting for amwa members � r. michelle sauer gehring 2022 walter c. alvarez award recipient: dr leana wen � kimberly korwek 2022 john p. mcgovern award recipient: peter j. hotez, md, phd � katrina r. burton 48 conference resiliency on display in denver: amwa 2022 medical writing & communication conference � kimberly korwek 49 calendar of meetings contents http://www.amwajournal.org 138 amwa journal / v36 n4 / 2021 / amwa.org f e a t u r e abstract an expanding need for clinical documentation and regulatory health authority interactions during drug development has drawn increased attention to the role of the regulatory medical writer. this role is frequently misunderstood and poorly recognized. the american medical writers association (amwa) formed a working group in 2020 dedicated to defining the value that regulatory medical writers contribute. the purpose of this article is to demonstrate the value that regulatory medical writers bring to the drug development and approval processes and to explore the ways in which efficiencies in regulatory writing can be increased. current models for success provide guidance on training to help medical writers achieve their full potential, but obstacles and barriers to medical writing efficiency and document quality remain. surveys developed by the amwa working group revealed that (1) regulators who review clinical documents believed that regulatory writers improve document quality and (2) writers are frequently recognized for leadership and collaboration. maximizing medical writing value requires thoughtful leadership and investment in training that includes both technical knowledge and soft-skill proficiency. introduction expansion of the biopharmaceutical industry has given rise to many jobs with very specialized skills sets supporting both the conducting and reporting of clinical trials. one of these specialized jobs is that of the medical writer. there are now several types of medical writers: those who focus on clinical data publication writing, those who support medical education and conference materials, and those who primarily prepare regulatory documentation supporting ongoing clinical trials (eg, clinical study protocols, investigator brochures, investigational new drug [ind] applications) and the reporting and submission of trial results to regulatory agencies (eg, clinical study reports and module 2 clinical summary documents for marketing applications). writers in this latter category have been termed “clinical writers,” “regulatory writers,” or “clinical– regulatory writers,” and exploration of the value of their role is the focus of this article. for purposes of the current discussion, these writers will be referred to as regulatory writers. companies engaged in the development of new medicines have a high need for expert communicators and devote substantial budgets to ensuring that documentation supporting clinical trials and regulatory submissions is accurate and of high quality. however, because company structures and team structures vary significantly, expectations of the role of the regulatory writer may also vary. full exploitation and harnessing of the writer’s skills and value requires members of the clinical project team to have a common understanding of the writer’s role. as this proposition regarding the value of the regulatory writer has become a prominent topic in the medical writing community, the american medical writers association (amwa) has formed a working group focused on understanding and communicating the value that regulatory writers bring to project teams. the remit of this working group included developing a series of surveys designed to gather information about the value that regulatory writers represent, as well as a thorough review of the literature to identify articles that address this topic. this article aims to demonstrate the value that regulatory writers bring to the drug development and approval process and to explore both common obstacles to efficiency and ways we can increase efficiencies in regulatory writing, including through improved training of medical writers industry wide. current models for success a medical writing competency model was developed by an industry-wide group of medical writers to provide guidance dylan harris,1 lisa chamberlain james,2 julia forjanic klapproth,3 brian bass,4 and angela russell winnier,5 on behalf of the amwa value of medical writing working group / 1takeda pharmaceutical company limited, lexington, ma, usa; 2trilogy writing and consulting, cambridge, united kingdom; 3trilogy writing and consulting, frankfurt, germany; 4bass global inc, fort myers, fl, usa; 5pfizer, the woodlands, tx, usa optimizing the value of regulatory medical writers amwa journal / v36 n4 / 2021 / amwa.org 139 on how to assure quality and consistency in the medical writing function.1,2 it also serves as a tool to describe the value and contributions of medical writers to drug development and medical communications. the model defines the essential knowledge, skills, abilities, and behaviors (ksabs) necessary for medical writing competency. it is purposefully designed to include the scope and breadth of the medical writing profession, and it is applicable to both medical writers and managers of medical writers.1 the competency model establishes 5 core competency domains through which the ksabs applicable to medical writing can be assessed and a medical writer’s competency can thus be certified.1,3 these 5 core competency domains are gathering, evaluating, organizing, interpreting, and presenting.3 they are the backbone of medical writing certification and the foundation of the medical writer certified (mwc) examination.1,4 in addition to defining and facilitating assessment of the core competencies that contribute to a medical writer’s value, the medical writing competency model and mwc examination inherently provide guidance on training to help medical writers achieve their full potential. obstacles to efficiency notwithstanding the training and competency models currently available, there are still substantial obstacles and barriers to efficient medical writing to be recognized, acknowledged, and overcome. these obstacles have a significant and direct impact on submission timelines, success, and ultimately the speed of delivery of new medicines to patients. lack of adequate writing skills and strategy documents prepared without using lean writing techniques take longer to write, review, approve, and therefore submit. they also slow down the regulatory review and approval by agencies. thus, not only the sponsors but also, ultimately, the end users of new drug treatments are affected by these documents that hinder readability and comprehension.5 oshiro et al surveyed registrants of 12 noncompulsory workshops on scientific publishing, in which respondents were asked what they found most difficult about preparing a manuscript.6 two of the most common barriers to manuscript publishing included uncertainty about how to organize. lean writing techniques and technical skill in writing help give a writer clarity in structuring thought and organizing it into a meaningful order with a good thought flow. when a document is structured to present data in a manner that builds ideas, the reader can more easily follow what the intended messages are and can more readily understand the conclusions. insufficient time a key barrier to efficient medical writing is having sufficient time to craft the documents. writing is an iterative process and writing the scientific documents that medical writers prepare is also a collaborative process involving multiple stakeholders, all of whom bring different perspectives that are relevant to the totality of the storyline. this means that timelines for the writing activities need to allow for sufficient time to pull a large amount of information together from multiple sources and weave it into a cohesive document. timelines need to permit teams the bandwidth to strategically review the ideas and data presented. complex documents with many interrelated topics may require multiple reads, with adequate timelines supporting this activity. in addition, the time available for medical writers to focus on the data presentations and honing of the messaging is often reduced because they are not given the right tools and processes to optimize their writing time. for example, in the absence of good templates, medical writers need to spend time on predefining headings, styles, and formats, which means that less time is available to spend on the scientific content.7 they might be given pdf files as source documents, which means they must spend time reformatting content taken from these files; or the team might insist on not using a lean approach to presenting the data, and the medical writers are asked to produce long, unwieldy documents full of bulk. because timelines are rarely extended to accommodate these extra activities, adequate checks for scientific rigor are foregone, errors may be overlooked, and the relevance of interrelated data points may not be captured.8 as writers face ever-accelerated looming deadlines, they are working longer hours, resulting in increased errors and an overall loss of quality. a study on quality metrics for clinical study reports found that for medical writers whose work rate exceeded the standard work rate by 1.5 times, it was more likely that major sections of the draft clinical study report required reworking than for medical writers whose work rate did not exceed the standard.9 insufficient training good and continued training is crucial to ensuring that these regulatory documents are being written by medical writers who have the lean writing skills to present the data with a structure that improves readability and guarantees they are fit for purpose. training is needed not only on communication of clinical messages but also in interpretation of the data in the first place. sharma highlighted that the key barrier that medical writers from india face in producing quality regulatory documentation is training because of a lack of a standardized training curriculum.10 lack of training can result in flaws in connecting the results to the conclusions, leading to claims that are not adequately supported or are erroneously reported.8 diong et al conducted an analysis on research 140 amwa journal / v36 n4 / 2021 / amwa.org papers and found poor statistical reporting, including implied or gross spin, use of standard errors or the mean to calculate data variability, and lack of p value reporting for primary analyses.11 this demonstrates a clear lack of understanding on how to be reporting this information, which could be avoided if medical writers had adequate training in this area. barriers to document quality given that regulatory documentation is critical for drug approval, these documents need to be of a high quality and accurately reflect the data supporting the proposed indication. review of regulatory documents by subject matter experts during the authoring process ensures that the data have been correctly interpreted and that key messages are supported; however, getting reviewers to provide the necessary input can be challenging. as a result of competing priorities, they often do not have sufficient time for their review, which results in inadequate checks of methods, results, or conclusions and can contribute to the introduction or oversight of errors.8 inconsistencies, both between documents in a submission dossier and between documents and their source data, hinder review by regulatory agencies, resulting in unnecessary questions and responses. li et al provided an example of the review of an ind submission in which a discrepancy in a definition of a key term, which on the face of it may seem relatively minor, confused a regulatory reviewer who questioned the sponsor in the regulatory response.12 this error, which would have been simple to correct during document review or quality control, led to wasted time and effort on the sponsor’s part and was a fully avoidable delay to approval. optimizing efficiency: impacts of leadership and training strategy on medical writing value maximizing medical writing value requires investment in training and thoughtful leadership. how a medical writing department utilizes its writers may impact the value potential of the team. managers who encourage specialization in a specific document type or phase of development (ie, the creation of functional silos) are working toward short-term efficiencies only. functional silos can result in inefficiency and employee dissatisfaction.13 avoiding those silos is critical for establishing an environment of flexible and creative problem-solving, and writer overspecialization can lead to reduced knowledge, collaboration, creativity, and confidence.14 this does not mean that medical writers should never work on the same document twice in a row. indeed, a writer needs to write any one document type several times to become truly confident in the unique features of that document and understand its needs. but by allowing writers to work on multiple document types, in different therapeutic areas, they gain a broader understanding of how the documents relate to each other and how they need modifications for different settings. this broader oversight makes them better able to advise teams and construct documents that are more fit for purpose. building an agile, broadly experienced team also positively impacts employee satisfaction and career development as it gives the writers more options to work in areas that better fit to their personal character (some writers enjoy writing about pharmacokinetics and others prefer safety topics), which keeps them engaged and gives them growth potential. effective leadership thus requires investment in crosstraining and broader development of writing staff; in other words, it requires seeking to create medical writing “generalists” rather than “specialists.” the value of generalists over specialists is known from other industries, and david epstein, author of range: why generalists triumph in a specialized world,15 describes the benefit of more generalized training like this: “the more varied your training is, the better able you’ll be to apply your skills flexibly to situations you haven’t seen.”16 this book describes many examples of the impact of broader education on the ability to solve problems creatively. the generalist trainee is not constrained to understanding the same repetitive pattern of working.15 likewise, a writer who has written for all phases of development and across a variety of regulatory and clinical document types will have a breadth of experience that lends itself to valuable and creative contributions to document strategy. beyond training at the document level, building a strong writing team requires leadership that combines informed hiring decisions with day-to-day demonstration of desired behaviors. when regulatory writers were surveyed, the skills they were most recognized for on their teams were leadership and collaboration skills (see the regulatory writer's perspective on page 152), indicating that these soft skills are a critical dimension of the regulatory writer’s role. the survey also revealed leadership skills, collaboration skills, and project management as the top areas in which writers desire more training. managers need to hire staff with the curiosity and team spirit needed to form a solid working group. the managers themselves then need to lead by example of the desired traits that solidifies a team. this includes showing a willingness to ask the right questions and to collect varying viewpoints on a problem (table 1 on next page). it also includes encouraging horizontal relationship-building with other functional areas so that the medical writing team has a shared vision and understanding of goals with those other functions.17 teammates who learn to collaborate across functional boundaries gain skills faster and increase business efficiencies.18 multiple studies describe a link between employee satisfaction and effective training.19 a study of human resource amwa journal / v36 n4 / 2021 / amwa.org 141 employees showed a statistically significant impact of training and development on employee satisfaction and concluded with a recommendation to provide training oriented not only to work tasks but also to the developmental goals of the employee (eg, more generalized training opportunities).20 not only do generalist skills aid writers’ development, but these skills can also help them to progress in their career. the progression from individual contributors to managers to enterprise-level leaders requires multiple “seismic shifts” in thinking, including a willingness to train as a generalist as opposed to a specialist.21 supporting this idea, a survey conducted in 2013 revealed that 60% of respondents felt their manager was a “good generalist” with broad transferable skills in people management and leadership, which are necessary for more senior positions in an organization.22 broad training strategies, then, need a company’s attention for both improving problem-solving as well as positively impacting employee satisfaction and development into more senior roles, all of which elevate the value of the medical writing organization. table 1. how to ask good questions common pitfalls effective inquiry start with yes-or-no questions. start with open-ended questions that minimize preconceptions. (“how are things going on your end?”; “what does your group see as the key opportunity in this space?”) continue asking overly general questions (“what’s on your mind?”) that may invite long off-point responses. as collaborations develop, ask questions that focus on specific issues but allow people plenty of room to elaborate. (“what do you know about x?”; “can you explain how that works?”) assume that you’ve grasped what speakers intended. check your understanding by summarizing what you’re hearing and asking explicitly for corrections or missing elements. (“does that sound right—am i missing anything?”; “can you help me fill in the gaps?”) assume the collaboration process will take care of itself. periodically take time to inquire into others’ experiences of the process or relationship. (“how do you think the project is going?”; “what could we do to work together more effectively?”) adapted from edmonson et al.18 soft skills that increase efficiency and add value soft skills, in addition to technical knowledge, are essential for medical writing success.1,2 these skills are increasingly recognized as an important contributor to competent job performance in a wide range of fields.1,2,23-36 a recent survey was conducted with human resources and learning development specialists, including c-level executives, senior managers, and managers/supervisors, at companies ranging in size from <1,000 to >50,000 employees in a variety of industries, including technology, manufacturing financial services, health care, retail, hospitality, telecommunications, and education.36 the survey found that across industries, the need for soft skills is nearly as difficult to fill as the need for hard skills.36 the most in-demand soft skills identified by survey participants were critical thinking, communication, and creativity.36 however, as the need for soft skills grows, they are only briefly mentioned within the context of medical writing.1 the medical writing competency model includes a list of soft skills in a supplementary table of general abilities that are applicable to all medical writers, regardless of their area of specialty.37 these soft skills include assertiveness, compromise, decisiveness, kindness, conflict resolution, flexibility, leadership, resilience, negotiation, and openness.37 many of the soft skills listed in the competency model are mentioned in other articles on medical writers and medical writing.1,2,23-35 many of these authors identify additional soft skills they believe are also crucial for medical writer and manager competency (table 2). table 2. important soft skill-based competencies not listed in the medical writing competency model1 soft skill cited in: project management pal 2019,24 limaye 2020,25 saleh 2020,27 guillemard 201428 time management heisel-stoehr and schindler 2012,23 flaherty 2014,26 nice 201630 multitasking heisel-stoehr and schindler 2012,23 pal 2019,24 nice 201630 critical thinking flaherty 2014,26 guillemard 201428 cultural competency heisel-stoehr and schindler 2012,23 flaherty 201426 ability to work independently heisel-stoehr and schindler 2012,23 pal 201924 work ethic heisel-stoehr and schindler 2012,23 flaherty 201426 attention to detail heisel-stoehr and schindler 2012,23 nice 201630 networking heisel-stoehr and schindler 201223 self-motivation pal 201924 142 amwa journal / v36 n4 / 2021 / amwa.org many of these soft skills are relevant to the competency, and ultimately to the value, of all medical writers. an analysis of regulatory medical writing job opportunities posted on the european medical writers association website between 2009 and 2011 ranked the behavioral and social soft skills required of medical writers by the frequency of their appearance in job posting advertisements (table 3). medical writers are recognized by drug development stakeholders, including study sponsors and government agencies, as valuable contributors to drug research and regulatory processes.32 part of that value lies in their technical understanding of how to craft thought and their regulatory understanding of the needs of the various documents. yet their soft-skill competency is an equally important aspect of their value for their ability to pull teams together and keep stakeholders focused on messaging, timelines, and collaborative work ethics. their ability to manage projects brings an essential value to their role. as noted by ohms, a good project manager shepherds their projects and understands the interplay of the different functional areas involved.38 ohms points out that the 4 features of an exceptional project manager are (1) respecting others earnestly, (2) knowing when to speak and let others speak, (3) understanding the details driving the project, and (4) taking the time to self-assess and maintain focus. all of these features typify the skills that a good medical writer needs to have to successfully complete their projects on time and with a well written document. feedback from regulatory agencies on the value of medical writers the amwa working group’s survey designed for regulators who review documentation prepared by medical writers gave some valuable insights into how the agencies perceive the role of medical writers and the value they bring to regulatory documents (see the regulator’s perspective on page 145). regulators recognized and acknowledged the value that medical writers add to the regulatory documents they work on. they believe that medical writers improve document quality, which, unsurprisingly, is extremely important for regulatory reviewers. they confirmed that poor document quality can hamper the ability of the reviewer to provide an assessment, which in turn delays the drug approval process and in some cases can even sensitize reviewers to subsequent submission documents from the same sponsor. these survey results provide meaningful data to support how we present ourselves within our organizations and how we should develop our medical writers—quality is clearly highly valued by regulators, and the regulators’ feedback illustrates the need for a sufficient supply of highly trained writers. ultimately, the regulatory reviewers made it clear that they are looking for lean but fully developed documents that make the scientific rationale clear and show how it is supported by the data. when training medical writers, we must equip them to lead teams to create documents that are concise and clearly present the message. there is also a clear need to focus on team management and soft skills that enable writers to lead and guide the authoring teams. we can conclude that many regulatory reviewers understand the role of medical writers and believe that they make the job of the reviewer easier. medical writers are clearly valued and respected by regulatory agencies, and these take-home messages should empower the medical writing profession and help to shape the ongoing training of medical writers. optimizing the role of the medical writer to optimize the role a medical writer plays on cross-functional teams, we need to understand the skill set that these writers require to play this role well. ultimately, a good medical writer must master 3 main areas: writing skills, understanding the regulatory needs of the documents they are writing, and interpersonal skills to effectively manage projects. writers need to have excellent writing skills to effectively communicate the thoughts and vision of the document from their teams. this involves not only knowing how to structure thought in well-formed sentences but also how to structure the document in such a way that a reader comprehends how the various data points build on each other to form the intended messages. developing a good medical writer, therefore, must begin by having someone who already has a talent and passion for writing and then must progress to guiding them to hone table 3. top-ranked soft skills in emwa job ads for regulatory medical writers: 2009-201123 behavioral skills percentage of ads social skills percentage of ads leadership, team working 62 communication 47 networking 56 interpersonal 22 organized 33 work independently 18 time management 30 detail-oriented 27 multitasking 15 conflict management 10 ads, advertisements; emwa, european medical writers association. amwa journal / v36 n4 / 2021 / amwa.org 143 their craft. like any talent, writing skills get better with training. teaching a writer to write better requires having someone who already has the skills to take the time to review and revise the text of the learning writer to show them how to improve. this is an investment of more than just giving them a wellwritten document and asking them to emulate it. it needs a trainer who will pull apart what the writer wrote, reconstruct it, and then take the time to explain why and how. people learn by making mistakes, and it is only when we are shown those mistakes and understand how to avoid them that the learning process takes place. writers also need to understand the unique purpose of each type of regulatory document. many of these documents contain similar information, but the intention of each document differs. some are meant to communicate to investigators, others are meant to communicate to regulatory reviewers, and all of them need to tell a slightly different part of the story for different purposes. medical writers not only need to learn the theory of the regulatory requirements specified by the international council for harmonisation of technical requirements for pharmaceuticals for human use and other agency guidelines that define what each document is meant to do but also need to be given sufficient guided practical training to see how teams build, discuss, and craft these documents. this includes having the opportunity to see feedback from agency reviewers on different types of documents and be part of teams who revise the documents in response to this feedback. think of the difference between learning to fly a plane by reading the instruction manual and spending 10,000 hours in the air with a coach. only the latter produces a seasoned pilot. this is an instance in which the concept of a generalist compared with a specialist becomes salient. ensuring that a writer has practical experience on a broad spectrum of documents across a clinical development program gives them more depth of knowledge and makes them more versatile overall. it means they can truly advise teams on what fit for purpose looks like for different document types and that they help teams achieve that. finally, to optimize the value of a medical writer, we need to ensure that writers can train on the soft skills identified previously. this requires creating a safe environment that empowers them to challenge their boundaries as they learn how to assert themselves and corral teams. this training should come initially through demonstration, as novice writers witness experienced writers steering their teams and collaboratively working alongside other functional areas to develop documents. as writers develop, they must be granted increasing responsibility for running simpler meetings with an experienced writer there to support them, if needed. the acquisition of soft skills can be the most challenging dimension of writer development. many writers are not extroverts by nature, and gaining the confidence to speak up and challenge subject matter experts often means overcoming their natural tendency to sit back and let others lead. by creating a situation in which writers first learn by example, writers are then allowed to execute within a safe environment and finally function independently once they have the necessary skills. we must give them the encouragement and security to grow without fear of embarrassment or risk of failure. in this way, we nurture strong, confident writers who have the wherewithal to collaborate with even the most demanding teams. through training and development with a focus on both technical and soft skills and identification of growth opportunities for new and developing writers, we can continue to address the challenges discussed here and foster the next generation of regulatory writers. author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. author contact: dylan.harris@takeda.com references 1. clemow db, wagner b, marshallsay c, et al. medical writing competency model—section 1: functions, tasks, and activities. ther innov regul sci. 2018;52(1):70-77. 2. clemow db, wagner b, marshallsay c, et al. medical writing competency model—section 2: knowledge, skills, abilities, and behaviors. ther innov regul sci. 2018;52(1):78-88. 3. clemow db, wagner 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schindler tm. pharmaceutical medical writing competencies: comparing self-perception with employers’ expectations. med writing. 2012;21(3):225-231. https://doi.org/10.1179/20474806 12z.00000000049 24. pal m. 7 essential skills to look for when you hire a medical writer. kolabtree blog website. published august 19, 2019. accessed february 24, 2021. https://www.kolabtree.com/blog/7-essential-skills-to-lookfor-when-you-hire-a-medical-writer 25. limaye n. medical writing: the language and art of scientific communication. dia global forum website. published may 2020. accessed february 24, 2021. https://globalforum.diaglobal.org/ issue/may-2020/medical-writing-the-language-and-art-of-scientificcommunication/ 26. flaherty k. soft skills: the critical accompaniment to technical skills. amwa j. 2014;29(2):70-72. 27. saleh m. a medical writer’s skillset. health writer hub website. published july 13, 2020. accessed february 24, 2021. https://www. healthwriterhub.com/a-medical-writers-skillset 28. guillemard m. medical writing skills: ten must-have attributes. health writer hub website. published january 13, 2014. accessed february 24, 2021. https://www.healthwriterhub.com/medical-writing-skills/ 29. henning a; trilogy writing & consulting. growing medical writing teams: strategies and best practices. int clin trials. february 2020; (special issue):10-14. 30. nice k. what skills do you need to be a good regulatory medical writer? impact pharmaceutical services website. published august 25, 2016. accessed february 24, 2021. https://www.impactpharma.com/blog/ what-skills-do-you-need-to-be-a-good-regulatory-medical-writer/ 31. smith k, winter-vann a; trilogy writing & consulting. the need for, and benefit of, good medical writing. int clin trials. february 2017;(special issue):10-13. 32. archer r, johnson mr, chipps e. evaluating the role of the regulatory writer. clin researcher. 2019;33(9). published november 12, 2019. accessed february 24, 2021. https://acrpnet.org/2019/11/12/ evaluating-the-role-of-the-regulatory-writer/ 33. klapproth jf. strategic benefits. int clin trials. 2011;2011:72-75. 34. klapproth jf. do you measure up? trilogy writing & consulting website. published may 2016. accessed february 24, 2021. https://www. trilogywriting.com/publications/do-you-measure-up/ 35. klapproth jf, james lc. how to build a medical writer: medical writing apprenticeships—new training for a new breed. amwa j. 2019;34(2): 76-78. 36. volzer d, burgess j, magda aj. reimagining the workforce 2021: closing the skills gap through education. wiley beyond website. published february 2021. accessed june 17, 2021. https://edservices.wiley.com/ wp-content/uploads/2021/02/202102-reimaginingtheworkforce2021report-wes.pdf 37. clemow db, wagner b, marshallsay c, et al. medical writing competency model—section 1: functions, tasks, and activities. ther innov regul sci. 2018;52(1):70-77. supplementary material, table s1. accessed february 24, 2021. https://static-content. springer.com/esm/art%3a10.1177%2f2168479017721585/ mediaobjects/43441_2018_5201070_moesm1_esm.pdf 38. ohms c. 4 skills an exceptional project manager can’t survive without. pharmaceutical online website. published july 22, 2020. accessed october 29, 2021. https://www.pharmaceuticalonline.com/doc/skillsan-exceptional-project-manager-can-t-survive-without-0001 general principles of word usage www.amwa.org/online_learning choose the right word for accuracy and clarity. https://www.forbes.com/sites/brentgleeson/2013/10/02/the-silo-mentality-how-to-break-down-the-barriers/ https://www.forbes.com/sites/brentgleeson/2013/10/02/the-silo-mentality-how-to-break-down-the-barriers/ https://www.forbes.com/sites/brentgleeson/2013/10/02/the-silo-mentality-how-to-break-down-the-barriers/ https://www.forbes.com/sites/brentgleeson/2013/10/02/the-silo-mentality-how-to-break-down-the-barriers/ https://knowledge.wharton.upenn.edu/article/generalists-vs-specialists/ https://knowledge.wharton.upenn.edu/article/generalists-vs-specialists/ https://zapier.com/blog/organizational-silos/ https://hbr.org/2019/05/cross-silo-leadership https://doi.org/10.1016/j.procs.2019.09.117 https://hbr.org/2012/06/how-managers-become-leaders https://www.theguardian.com/careers/careers-blog/specialist-generalist-what-do-employers-want https://www.theguardian.com/careers/careers-blog/specialist-generalist-what-do-employers-want https://doi.org/10.1179/2047480612z.00000000049 https://www.kolabtree.com/blog/7-essential-skills-to-look-for-when-you-hire-a-medical-writer https://www.kolabtree.com/blog/7-essential-skills-to-look-for-when-you-hire-a-medical-writer https://globalforum.diaglobal.org/issue/may-2020/medical-writing-the-language-and-art-of-scientific-communication/ https://www.healthwriterhub.com/a-medical-writers-skillset https://www.healthwriterhub.com/medical-writing-skills/ https://www.impactpharma.com/blog/what-skills-do-you-need-to-be-a-good-regulatory-medical-writer/ https://acrpnet.org/2019/11/12/evaluating-the-role-of-the-regulatory-writer/ https://www.trilogywriting.com/publications/do-you-measure-up/ https://edservices.wiley.com/wp-content/uploads/2021/02/202102-reimaginingtheworkforce2021-report-wes.pdf https://static-content.springer.com/esm/art%3a10.1177%2f2168479017721585/mediaobjects/43441_2018_5201070_moesm1_esm.pdf https://www.pharmaceuticalonline.com/doc/skills-an-exceptional-project-manager-can-t-survive-without-0001 https://www.pharmaceuticalonline.com/doc/skills-an-exceptional-project-manager-can-t-survive-without-0001 amwa journal / v36 n1 / 2021 / amwa.org 15 session reports conference coverage2020 amwa medical writing & communication conference dates: tbd location: online trends and opportunities for medical communicators table 2. strategies for meeting each time-management challenge challenge strategy increase efficiency 1. keep track of project details (eg, onenote). 2. use organizational templates. 3. maintain an accurate schedule of your projects. start quickly and effectively for starting your day… 1. before leaving work, plan a specific task for the beginning of the next day. 2. work during your most productive working hours. 3. jumpstart your day with an easy task or get a difficult task out of the way early. 4. maintain big-, medium-, and small-picture plans of goals. for starting a project… 1. plan time for getting organized. 2. gather all needed materials before beginning. 3. begin with easy tasks to familiarize yourself with the project. 4. use a spreadsheet to track parts of the project. fight procrastination 1. work in small time chunks (<3 hours). 2. enforce breaks to foster and enhance creativity. 3. use mindless tasks as a break between projects. 4. commit to working on an undesirable task for 5 minutes; this pledge tricks you into working longer. 5. monitor time realistically to find time sinks. 6. avoid procrastination pitfalls (eg, facebook, perfecting powerpoint slides). manage distractions 1. do one thing at a time. 2. use a “to-do” checklist. 3. only check emails at specific times of day. 4. schedule known interruptions. 5. postpone your response to nonurgent emails. 6. use “do not disturb” digital functions when necessary. control your meetings 1. schedule meetings with enough notice to allow for participants’ preparation. 2. provide a clear agenda. 3. keep and disseminate accurate and detailed notes. 4. schedule 15 minutes before and after a meeting to allow for final preparation and follow-up. 5. follow up immediately after the meeting. 6. communicate clearly. protect your time 1. keep your calendar up to date; block off work time. 2. say “no,” if needed, yet offer a solution or an alternative. 3. be clear about expectations (yours and client’s) around a project. 4. frontload your day or week. tricks and tips for time management speaker melissa christianson, phd, whitsell innovations, inc, chapel hill, nc by jennifer l. busch, phd “imagine this: you are promised $86,400 per day for the rest of your life. you must use the money each day, or you will lose it; none of it carries over to the next day.” dr melissa christianson of whitsell innovations began her presentation with this attention-grabbing scenario. each day contains 86,400 seconds, she informed her audience. she then offered suggestions for stewarding this nonrenewable resource. the presentation was divided into 6 sections. each section included a threat to time management, a challenge with which to confront each threat, and several strategies for each challenge (tables 1 and 2). dr christianson encouraged the attendees to modify and personalize her strategy suggestions as needed. she concluded her talk with an admonition concerning time: “use it, don’t lose it.” table 1. threats to optimal time management and challenges with which to combat each threat threat challenge inefficient use of time increase efficiency prolonged decision-making time start quickly and effectively a self-reported 4-fold increase in procrastination within the past 30 years fight procrastination interruptions (they steal 90 minutes per day, and 23 minutes are needed to return to productive work after each one.) manage distractions unproductive time in meetings (up to half of one’s career is spent in meetings.) control your meetings scarcity mindset (the busier a person, the harder it is for him/her to decline a new request.) protect your time jennifer l. busch is an associate professor of biology at wheaton college, wheaton, il. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: jennifer.busch@wheaton.edu mailto:jennifer.busch@wheaton.edu 16 amwa journal / v36 n1 / 2021 / amwa.org low-cost and low-effort ways to create infographics and visually appealing slides speaker kelly schrank, ma, els, head bookworm, bookworm editing services llc, canastota, ny by raeesa gupte, phd many medical communicators are encountering a rising demand for visual-communication services from their clients and employers. visual communication uses charts, graphs, and images to simplify and convey complex information or patterns in data. infographics and slides use elements of visual communication to present concepts in a new way. at amwa’s 2020 medical writing and communication conference, kelly schrank gave an introduction to and step-bystep tutorials for non–graphic designers on how to create visually appealing infographics and slides without the use of expensive software. “you need to have some patience, willingness to learn powerpoint a little deeper or a new application, and some interest in breaking away from the words and thinking in a new way about how to present data,” schrank emphasized. what is an infographic? an infographic contains visual elements (color coding, graphics, and icons), content (time frames, statistics, and references), and knowledge (facts and deductions). it uses different colors, shapes, sizes, fonts, and icons to • highlight main ideas, • connect ideas or data, and • compare and contrast information. color is used to accentuate important data or to separate sections of an infographic. shapes of different sizes are used to make comparison easier. icons may be used as bullets or for visual representation of ideas conveyed through text. types of infographics infographics may appear in different formats: • images • oneor 2-page handouts • rolling infographics that appear on websites and need to be scrolled through popular types of infographics include • timelines, • processes and how-to guides, • comparisons, • lists, and • maps. how to create infographics an easy way to start building an infographic is to use a template. templates make it easy to choose coordinating colors and fonts, thus ensuring style and consistency. in addition, templates can be customized by changing design elements and including the information you want to present. schrank shared information on applications that have templates available for infographics (table 1). both free and paid versions of these applications are available. however, the free versions may be watermarked or shared on the website’s public domain. to protect client data and privacy, paid versions of the applications are preferred. to avoid the constraints of commercial infographic software, schrank relies on powerpoint. she suggests using native powerpoint templates available with microsoft office 365. alternatively, you can download templates for free from websites like hubspot. schrank provided a tutorial on how to customize infographic templates by changing shapes, colors, font sizes, and reordering or editing content. detailed instructions can be found in the presentation handout (link in resources). how to create visually appealing slides visually appealing slides rely on the same basic elements as infographics; they • make good use of color, • put text into shapes or smartart, • use different text size to show importance, and • use icons to add visual interest and connect ideas. instead of using slides with standard bulleted lists or walls of text, thematically associated slides can be used to tell an table 1. comparison of websites offering infographic templates site free option? able to export? public publication? watermark/ branding? paid option (individual) https://www.canva.com/ yes yes no no ~$10/mo https://piktochart.com/ yes yes yes yes ~$29/mo https://www.visme.co/ yes yes yes yes ~$39/mo https://infogram.com/ yes no yes yes ~$19/mo https://venngage.com/ yes no yes yes ~$49/mo https://www.canva.com/ https://piktochart.com/ https://www.visme.co/ https://infogram.com/ https://venngage.com/ amwa journal / v36 n1 / 2021 / amwa.org 17 a powerful combination: the value of the writer–editor partnership speaker crystal herron, phd, els, managing director, redwood ink, san francisco bay area, ca by christine holzmueller, ms crystal herron’s goal in this presentation was not simply to deliver information to the audience. her goal was to ask us questions to promote self-reflection on our capabilities and careers and to consider the “value a writer–editor partnership could bring to our professional endeavors.” she acknowledged basic similarities between writers and editors but pointed to different qualities and functions of each role. for one, writers are creative with words whereas editors analyze and fix text. writers also tend to research a subject, transfer knowledge, and become deeply knowledgeable about a subject. conversely, editors focus on examining the writing and revising the text to improve it, and they may require less knowledge of the subject matter. medical communicators often both write and edit content. herron questioned this dual role, noting most people are stronger in one area. she listed some pros and cons of being a generalist (both roles) compared with being a specialist, showing career value in the latter role (figure). if you specialize and form a partnership, herron believes “you can harness your strengths and focus on what you really enjoy” and let your partner complement your weak areas. what are some benefits of this partnership? one benefit herron stressed related to the “curse of knowledge.” the concept is that we omit information, unaware that we assume the reader knows what we know. a partner can identify these knowledge gaps in a document, find mistakes we overlook, and strengthen our writing. they can be a mentor. this person can give objective feedback and help divest our emotional attachment to our text. a partner can also save us time by taking on the refinement of documents. importantly, a effective story. to accomplish this, microsoft office 365 provides powerful tools such as • templates, • design ideas, • smartart, • icons, and • stock images. older versions of powerpoint do not have infographic templates or the design ideas function and have fewer options for smartart, icons, and stock images. although websites like canva, piktochart, and visme also provide templates and stock images, they are harder to export and may be watermarked. schrank shared the following tips and tricks for creating visually appealing slides: • convert bulleted lists to smartart. • convert smartart to shapes. • use shapes to make your own smartart. • get inspiration from the design ideas function. • adjust icons. • add stock photos. schrank provided a step-by-step tutorial for each of the actions mentioned above. detailed instructions can be found in the presentation handout (link in resources). closing kelly schrank closed the presentation with ideas for infographics and visually appealing slides by sharing some of her own work. she also suggests performing a search on google images to learn more about the elements of good design, discover new design ideas, and see what is currently in vogue. resources websites for stock images: https://pixabay.com/ https://unsplash.com/ https://thenounproject.com/ https://www.pexels.com/ presentation handout: https://headbookworm.com/wp-content/uploads/2020/10/ amwa-2020-low-cost-and-low-effort-infographics-andvisually-appealing-slides-handout.pdf raeesa gupte is a freelance medical and regulatory writer specializing in clinical evaluation reports for medical devices. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: raeesagupte@gmail.com figure. pros and cons of generalist compared with specialist.figure. pros and cons of generalist compared with specialist. specialist pros in-depth knowledge brings ▼ greater value to team & company & thus ▼ + more power + higher earnings + greater job security specialist cons some career inflexibility generalist cons • sacrifice depth for breadth of knowledge • lower earnings • greater job insecurity generalist pros • broader knowledge • more transferrable skills • career flexibility figure. pros and cons of generalist compared with specialist. specialist pros in-depth knowledge brings ▼ greater value to team & company & thus ▼ + more power + higher earnings + greater job security specialist cons some career inflexibility generalist cons • sacrifice depth for breadth of knowledge • lower earnings • greater job insecurity generalist pros • broader knowledge • more transferrable skills • career flexibility session reports https://pixabay.com/ https://unsplash.com/ https://thenounproject.com/ https://www.pexels.com/ https://headbookworm.com/wp-content/uploads/2020/10/amwa-2020-low-cost-and-low-effort-infographics-and-visually-appealing-slides-handout.pdf mailto:raeesagupte@gmail.com 18 amwa journal / v36 n1 / 2021 / amwa.org editing: hard knowledge, soft skills speaker loretta bohn, els, senior editor/writer, rti international, chapel hill, nc crystal herron, phd, els, managing director, redwood ink, san francisco bay area, ca erica goodoff, els(d), senior scientific editor, md anderson cancer center, houston, tx by kelly schrank, ma, els this panel of diverse editors provided their personal experience and advice in 5 areas: credentials, developing judgement, editing on a team and individually, managing expectations, and professional development. credentials although herron has a doctorate, she doesn’t think you need one to be an editor in our field; instead, she thinks you need to “be a master of the language and have an interest in the science.” neither bohn nor goodoff have degrees in the sciences, but bohn says that you need to be curious, and she enjoys “learning about subject matter and learning about language, as it changes all the time.” goodoff mentioned editor in the life sciences (els) and els diplomate [els(d)] as credentials that she thinks are well known in our field. the els credential helped her, she said, because “those letters after my name did help me get interviewed for my current job.” bohn also mentioned that the amwa essential skills certificates and other medical writing & communication conference (mwcc) workshops and sessions gave her ways to talk about what she is doing and why. developing judgement the panel posed the questions, “how do you know what to do when—how do you develop judgement about when to just change something, when to change and query, and when to just query, and how do you just let something go?” goodoff defaults to “if you aren’t sure, ask.” it’s nice if you have someone to ask, such as a colleague or a message board, or you can query the author for clarification. as she and bohn note, “people writing science manuscripts are happy to talk about their research.” bohn also brought up that if and when you query might depend on how long you have worked with an author or team. herron added, “it helps to know who you are working with. if it’s someone who is new, you want to be a little more careful.” queries may also need to be changed over the course of a reading; bohn, goodoff, and herron noted that they often find their queries answered by the end of the manuscript. they agree you should reread your queries before returning the document to the author. partner can make us look good and help us achieve our career goals and advancement. what are key features of an ideal partnership? herron showed a venn diagram of 1 skill-based and 3 relationship-based features of an ideal partnership: • complementary skills that form a larger skill set that you could not accomplish alone. • confidence that you can trust and rely on each other. • chemistry in how you relate to one another. both must respect and value their partner and work well around decision-making, disagreements, and conflict resolution. • similar values. herron described this as a core feature to figure out ahead of time rather than waiting until “something pops up and values diverge.” some questions you need to answer are: do you have similar work ethics (deadlinedriven vs value-driven) and styles (prefer to work early in the morning vs later in the day)? do you have matching communication styles and similar risk-taking behaviors? do you share the same goals and have a similar vision for your partnership? is there equal commitment to the work or a clear agreement on whether one person will do more work? how can you find and establish a successful partnership? to find the right partner, consider colleagues you personally worked with that meet the key features of a successful partnership. other approaches are networking at conferences and through professional online platforms (eg, linkedin), soliciting interest through professional organizations (eg, amwa website), and simply being open and ready for a chance meeting in any public space. you can establish a partnership at work by searching within your company for a viable candidate. another option is to contract with a consultant for a trial period to see if it works well and then hire them or someone else as an employee. if you are self-employed, you might draw up a contract agreement and establish a formal partnership. herron ended with several questions to deepen our consideration of the value added from a writer–editor partnership: 1. what is your vision? 2. what are your strengths and weaknesses? 3. what are your interests and professional goals? 4. what are your company’s goals? christine holzmueller is a senior technical writer for the johns hopkins university school of medicine. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: cholzmu1@jhmi.edu mailto:cholzmu1@jhmi.edu amwa journal / v36 n1 / 2021 / amwa.org 19 collaborative writing: ensure success with an effective strategy speaker crystal herron, phd, els, managing director, redwood ink, san francisco bay area, ca by sadie van dyne, phd collaborative writing projects often stir up a mix of emotions in the writing professionals tasked with their completion. while these collaborative projects can provide an opportunity to learn new skills, generate new ideas, and gain new perspectives, negative feelings can overwhelm those involved and hinder the writing process. however, before memories of collaborative project-induced dread could set in attendees of amwa’s 2020 medical writing & communication conference, crystal herron, phd, els, highlighted strategies to use in three key phases of the writing process to help rein in those overwhelming negative emotions. the planning phase deriving all the benefits collaborative writing can offer begins in the planning stage. herron recommended attendees use a project-management approach. this approach includes creating a feasible schedule that takes the project scope, work style of team members, and prior obligations into consideration. team members should agree on a file naming convention that works well for everyone. creating an organized storage structure (figure) can also help streamline the writing process. herron also offered this helpful organizational tip: archive older versions of files and store the most up-to-date version of a document in each version folder. editing on a team and individually bohn, goodoff, and herron were all mentored by more experienced editors earlier in their careers; these senior editors provided feedback and helped them get up to speed with their companies’ ways of doing things. more broadly, herron also found it helpful to see how these more senior editors “edited documents and to learn from that.” bohn discussed the advantages of editing and working with a team of editors as having others who “get” what you do, who can assist when you are overbooked, and who can help when you are struggling with questions or internal clients. as someone with her own business, herron has a network of editors she works with, whom she can ask for assistance when she has too much work. managing expectations bohn can ask editors on her team to assist if there is not enough time to meet an internal client’s deadline. goodoff said that in her work, she has to balance time with thoroughness and prioritize certain types of documents over others (for example, grants over manuscripts). she provides authors with a time estimate for editing that bakes in the other work ahead of the new project. bohn said that one way to manage expectations is to stay in contact with internal clients through a monthly email to ask them about upcoming work. herron’s approach is to underpromise and overdeliver, so she has a cushion if things don’t go as planned but leaves clients happy if the work goes well. all mentioned the helpfulness of discussing the levels of edit with authors/clients and which level can be accommodated within their timelines. bohn’s team also provides a calculator to authors so they can estimate their projects before submitting. professional development goodoff started off this discussion with 3 things she tries to work on. she explains, “it’s always a good idea to brush up on skills, especially things that you don’t see every single day but that you see often enough,” like statistics. despite having a writing and editing background, she thinks brushing up on grammar gives her the vocabulary to explain to authors why she is making certain changes to their writing. she also likes to learn word tips and tricks, saying she “finds some new little trick every single time.” herron believes it “improves your work” to put in the time for professional development. she believes that if you get certificates, you can make up for the cost by giving yourself a pay bump. to make sure she spends time on professional development, she adds it to her calendar on her historically slower days. sometimes she just spends an extended lunch time reading up on something or squeezes in just 15 minutes of reading here and there. bohn liked herron’s idea of “making it bite-sized” and focusing on 1 idea and what you can read/learn in 15 minutes. tips: erica goodoff: if you’re early in your career, the els credential is worth it. loretta bohn: always go back and reread your queries when done editing the full document. crystal herron: keep a file of boilerplate comments: just copy and paste into comments. (bonus from chat: use autocorrect to insert boilerplate comments or create macros to insert them into docs.) crystal herron: focus on one thing a month to learn/brush up on skills. (bonus: teach it to others on a blog to learn it better.) kelly schrank is a freelance medical editor and technical writer in canastota, ny, and the head bookworm at bookworm editing services llc. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: kelly@headbookworm.com session reports mailto:kelly@headbookworm.com 20 amwa journal / v36 n1 / 2021 / amwa.org strategies for effective risk communication speaker melissa christianson, phd, medical writer and consultant, whitsell innovations, inc., chapel hill, nc by núria waddington negrão, phd good risk communication is key for empowering patients and the public in general to make informed decisions about their health. however, since risk communication involves an interplay of complex mathematical concepts, personal beliefs, and emotions, effective risk communication can be hard to achieve. for example, if we compare some of the things that people are most afraid of, such as terrorist attacks, gun crime, and bird flu, with the things that cause the most deaths, cardiovascular disease and cancer, we see that there is a disconnect in society between perceived risk and actual risk. identifying a strong leader who can take on responsibility is also a necessity during the planning phase. general duties of the team leader include the following: 1. managing deadlines 2. updating team members 3. scheduling and directing meetings 4. combining drafted sections 5. coordinating with editors 6. proofreading 7. submitting final product 8. following up with client the writing phase herron discussed three different collaborative writing methods: layering, combining, and stitching. the layering method involves the team meeting to discuss the content and overall direction of the project while one person (usually the team leader) writes the first draft. the draft is then sent to the team members, who then weave, or layer, their ideas into the existing text. this method allows for a more continuous writing style. the combining method of writing allows for each team member to contribute written content. the team meets to discuss content and outlines major themes or sections. each section is delegated to a team member and returned to the team leader. the leader then combines each section into a comprehensive document. this method is time-efficient and allows for each writer to use their strengths. finally, the stitching method takes a highly structured and focused approach. the team meets to discuss content and outlines each paragraph, including topic sentences. team members are assigned a specific paragraph and the team leader stitches each paragraph together. the stitched document is then returned to the team to refine. while this method does require more meetings to plan specific content, the time invested up-front can ultimately help save time later. the editing phase establishing an efficient editing process is critical in collaborative writing. herron discussed the pros and cons of two different review styles. first, she described in-parallel editing as a process in which the team leader sends the document to each team member to review simultaneously. the leader is then responsible for incorporating revisions into one document. incorporating and keeping track of each author’s edits can be challenging for the team leader. similarly, team members may make duplicate edits or edit an old draft. this can introduce inefficiencies, as each team member is unable to see other authors’ perspectives and may not be updated about the status of the project. overall, herron discouraged attendees from using this method of editing. in-series editing is a timeand effort-saving alternative. the team leader sends a draft to author 1 to make edits. in turn, author 1 sends the edited draft to author 2 for review. the series continues until each author has edited the document, which is then returned to the leader. this method eliminates the possibility of duplicate edits. furthermore, each author can see the revisions other authors suggest, making for a more efficient process. conclusion overall, herron reminded attendees the best process to follow in collaborative writing projects is the one that works for your team. considering the members of the team, knowing their strengths and weaknesses, and knowing each team member’s professional goals can help identify the most appropriate methods to use throughout all major phases of the collaborative writing process. sadie van dyne is a freelance medical writer based in buffalo, ny. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: skdierschke@gmail.com figure. example file structure. mailto:skdierschke@gmail.com amwa journal / v36 n1 / 2021 / amwa.org 21 in her talk, dr. melissa christianson, a medical writer and consultant at whitsell innovations, inc., defined risk as “the probability of the occurrence of an event or outcome” and emphasized that risk communication is “the open, two-way exchange of information and opinion about risk, leading to a better understanding of the risk in question and promoting better (clinical) decisions about management” with no clear right answer.1 “successful risk communication points out hazards and helps navigate crises and avoid danger.” in medical communication, we typically talk about incidence, the number of new cases, prevalence, the total number of cases, absolute risk, the probability of an outcome in a population, and relative risk, a comparison of the absolute risk between 2 populations. the role of medical writers is to bring clarity in how these concepts are presented to the target audience. dr. christianson identified 4 major obstacles for clear risk communication. the first is that the math involved is hard and many people, even college-educated individuals, do not have the numeracy skills to “do the basic computations that are necessary to understand risk.”2–4 this leads to general overestimation of risks and inconsistent interpretation of equivalent data. the second obstacle to effective risk communication is that we are inconsistent in the way we assess risk.2,5,6 many variables influence our assessment of risk, such as the statistical measure used to present the risk, the framing of the data, mental shortcuts, emotions, and our numeracy and literacy skills.7 the speaker gave various examples of how the way the risk is described affects the audiences’ perception of the risk and consequent decision-making. people understand absolute risk better than relative risk, but presenting the relative risk leads to an overestimation of the effect and, therefore, to treatment acceptance.3,5,8,9 studies have shown that how we frame the data is extremely important. for example, when told that “32% of patients were dead 1 year after treatment,” more patients chose to take the treatment than those told that “68% of patients were alive 1 year after treatment,” even though these 2 statements represent the same risk of death.10 the last 2 obstacles to risk communication are that doctors and scientists speak a different language than the public and that personal beliefs enter the mix as well. dr. christianson emphasized the need to be careful with the word “significant,” which is normally interpreted as meaning “clinically significant” by the general population. finally, dr. christianson presented 6 strategies for better risk communication. strategy number 1 is to start basic, to not assume that your audience already understands the background information, and to clearly define the risk, the time interval, and the population. strategy number 2 is to make the math as easy as possible to increase the chance of the appropriate interpretation of the numbers. best practices are to use natural frequencies (2 out of 100 people), to use a mix of numeric and verbal descriptors (low risk—10%), to present the absolute risk or combine it with the relative risk (risk of a was 10% and risk of b was 20%), to use visual aids, and to build up to multiple levels of precision. strategy number 3 is to be consistent when comparing between different treatments and to use the same statistical measure, population, time interval, denominator, and framing. strategy number 4 is to give context, be careful when presenting risk comparisons, and consider using an incremental risk format. for example, present the background risk of an outcome regardless of intervention. strategy number 5 is to reduce the emotion by eliminating emotive language, using balanced framing, and being open about what is known and what is not known. strategy number 6 is to write to the audience. take into consideration the socioeconomic makeup, concerns, habits, and knowledge of your audience when writing and “proactively intervene if your audience will have trouble assessing or acting on the risk.” in summary, dr. christianson advises us to “use our tools wisely” when communicating risk. núria waddington negrão is a freelance medical editor at cactus communications in maputo, mozambique. author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. author contact: nurianegrao@gmail.com references 1. ahl as, acree ja, gipson ps, mcdowell rm, miller l, mcelvaine md. standardization of nomenclature for animal health risk analysis. rev sci tech. 1993;12(4):1045-1053. 2. carey m, herrmann a, hall a, mansfield e, fakes k. exploring health literacy and preferences for risk communication among medical oncology patients. plos one. 2018;13(9):e0203988. 3. gigerenzer g, gaissmaier w, kurz-milcke e, schwartz lm, woloshin s. helping doctors and patients make sense of health statistics. psychol sci public interest. 2007;8(2):53-96. 4. lipkus im, samsa g, rimmer bk. general performance on a numeracy scale among highly educated samples. med decis making. 2001;21(1): 37-44. 5. fagerlin a, zikmund-fisher bj, ubel pa. helping patients decide: ten steps to better risk communication. j natl cancer inst. 2011;103(19):1436-1443. 6. james lc. legislation and the lay audience: challenges of communicating benefit and risk in the light of new regulations. medical writing. 2015;24(4):195-199. 7. rakow t, heard cl, newell br. meeting three challenges in risk communication: phenomena, numbers, and emotions. pol ins behav brain sci. 2015;2(1):147-156. 8. sheridan sl, pignone mp, lewis cl. a randomized comparison of patients’ understanding of number needed to treat and other common risk reduction formats. j gen intern med. 2003;18(11):884-892. 9. covey j. a meta-analysis of the effects of presenting treatment benefits in different formats. med decis making. 2007;27(5):638-654. 10. mcneil bj, pauker sg, sox hc jr, tversky a. on the elicitation of preferences for alternative therapies. n engl j med. 1982;306(21): 1259-1262. session reports mailto:nurianegrao@gmail.com 22 amwa journal / v36 n1 / 2021 / amwa.org mentoring programs: one size may not fit all speaker mary burder, phd, senior medical writer, parexel international, durham, nc by niada niederhauser, bs as the demand for skilled medical writers increases, medical communication and regulatory medical writing companies are seeing the value of mentorships; however, different mentorships fit different situations. at amwa’s first virtual conference, parexel international’s senior medical writer, mary burder, described 3 different mentoring programs and highlighted how they can benefit both employees and their companies. the 3 mentoring programs included new hire mentoring, project mentoring, and role shadowing. the benefits of mentoring and best practices for implementing mentoring relationships were also discussed. mentoring programs benefit both companies and employees: • mentees can learn new knowledge-based skills, build confidence, and advance their medical writing career. • companies can see improved productivity levels and increased employee retention and satisfaction and facilitate a culture of growth. • mentoring relationships can foster cross-cultural exchange and understanding while improving communication skills. when implementing mentoring programs, best practices should be developed first to ensure the programs are beneficial and to clearly define the mentor/mentee responsibilities. some practices are specific to certain mentorships, but others are applicable to all programs. the most important general best practice, according to burder, is to define the goals of the mentorship based on the needs of the mentees before the first meeting. during the mentorship, mentees should proactively disclose their needs to their mentors to assure the appropriate knowledge and skills are conveyed. scheduling regularly occurring meetings is a must; both mentees and mentors should commit to attending. mentors should encourage mentees to propose job-relevant topics for their meetings. mentors should willingly share experiences, both positive and negative, as well as be approachable and accessible outside of meetings for support and feedback. as the program continues, mentoring style should adapt to the mentees’ advancing skill level and job responsibilities. the first mentoring program discussed in burder’s presentation was the new hire program, which enables new employees to acquire specific skills and knowledge needed to excel in their job. new hire mentoring differs from onboard training, as the latter is the core information conveyed to all new employees. by contrast, new hire mentoring is focused on helping the mentee acquire the knowledge, skills, and understanding of the processes and workflows specifically relevant to the new job. mentors should provide examples of well-written documents, which should be closely reviewed to highlight key features that make the document effective. mentors should also incorporate hands-on training, perhaps allowing mentees to work on small parts of the mentors’ projects while the mentors provide guidance and feedback. effective new hire mentoring programs should enable mentees to become self-sufficient more quickly, boost confidence, and ensure a smooth adjustment to the new job’s responsibilities. project mentoring, the second program presented by burder, focuses on ensuring current employees achieve specific new levels of knowledge and skills to take on more challenging roles so that they are equipped to skillfully complete projects and meet clients’ needs. burder pointed out that line managers or team leads usually assign their employees to the project mentoring program. mentors are responsible for guiding mentees on specific document preparation and providing feedback on performance. effective project mentoring programs enable mentees to acquire new project/role-related skills, promote professional development, and may increase employee retention and satisfaction. role shadowing, the last program discussed by burder, differs from the other mentoring programs in that mentees request the opportunity to acquire knowledge and skills needed to transition to new responsibilities or positions within the company. role shadowing exposes mentees to new roles, projects, and complex processes while conveying how to apply certain job-related skills. it can be either observational, in which mentees observe meetings and interactions, or hands-on, which allows mentees to perform small tasks to be reviewed by mentors. burder closed the presentation with a summary of mentoring programs while emphasizing how their success depends on determining mentoring objectives before implementation. niada niederhauser is a medical writing and editing student at the university of chicago and freelance writer in severn, md. author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. author contact: niadan@gmail.com mailto:niadan@gmail.com amwa journal / v36 n1 / 2021 / amwa.org 23 mentee. there are few things that we don’t talk about. … our mentoring relationship helps me grow and learn as much as my mentee.” so, how do you create a maximal mentoring relationship? what is the “secret sauce?” according to morris, there are 4 important ingredients to establishing and maintaining this valuable connection: 1. relationship: in maximal mentoring, friendship comes first, and the professional relationship comes second. 2. connection: it is important for the mentor and mentee to have a strong connection. they must care about each other’s success, be responsive to communication, and create a safe space for each other. a firm commitment is required, with many maximal mentoring agreements and logistics outlined in a document or contract. 3. acceptance: the mentor and mentee must accept each other for who they are with no judgment. there is no hidden agenda or pretending to be someone else; the “masks are off.” the mentor and mentee can discover their best selves, and both are able to take risks within the privacy and safety of the relationship. 4. preferred traits on the part of the mentor and mentee: a. trust and mutual respect b. interdependence c. authenticity d. vulnerability e. patience if maximal mentoring does not sound feasible, morris suggests starting with reverse mentoring. reverse mentoring is when a younger, inexperienced employee is paired with a senior executive who is willing to learn. the younger employee exposes the executive to issues important to the younger generation and addresses gaps in the executive’s technology skills. this style of mentoring helps the organization retain young talented professionals while increasing representation of the younger demographic throughout the organization. morris summarizes the most important aspects of building a meaningful mentoring relationship as follows: 1. build a relationship based on candor and trust. 2. look for opportunities to explore professional goals and personal dreams. 3. be open to give and receive critical feedback, sharing successes and mistakes. christina barnes is a freelance medical writer, https://www.christinabarnes.com/, columbus, ohio author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: christina.barnes712@gmail.com session reports analysis of mentoring: from marginal to maximal speaker susan morris, med, cpcc, acc, susan morris coaching by christina barnes, msn, rn, cpnp one of the most important business relationships is the mentoring relationship. traditionally, the mentoring relationship has been innately hierarchical, with the mentor as the expert and the mentee as the junior or apprentice. morris classifies this type of mentoring as traditional or minimal mentoring. “learning goes in one direction, from the mentor to the mentee,” morris says. “the mentee is dependent on the mentor.” morris advocates for moving away from this minimal model and instead adopting a mentoring relationship that opens possibilities for both the mentor and the mentee. morris calls this mutually beneficial model of mentoring “maximal mentoring,” and she encourages professionals to cultivate this type of mentoring relationship within their own network. what is maximal mentoring? maximal mentoring is a professional relationship between a mentor and a mentee that is mutually beneficial. the expectations of both parties are exceeded. the mentoring process is not generic, but rather is highly customized to the needs of the mentee. there is an emphasis on the mentee as a whole person; the focus goes beyond career-related needs and goals. the relationship is transformational, as both the mentor and mentee change as a result of this style of mentoring. traditional or minimal mentoring, in contrast, is a generic professional relationship. the mentor has a standardized way of mentoring others that is not tailored to the needs of the specific mentee. this is usually a tr ansactional relationship or exchange; the mentee needs a job, and if the mentor helps the mentee find a job, the mentor hopes for access to the mentee’s network. the focus in this relationship is solely on career development. the mentee is dependent on the mentor, and the 2 are not considered to be equals. maximal mentoring requires mentors and mentees to move away from the mindset of traditional mentoring. in doing this, mentors and mentees can enjoy a relationship founded on equality, respect, and trust. “learning is a twoway street” in maximal mentoring, says morris. the mentor and mentee are equals, and there is the expectation that they will learn from each other. both the mentor and mentee can experience personal and professional growth as a result of this relationship. maximal mentoring can be “positive, uplifting, appealing, attractive, and fun,” morris says. the mentor and mentee can expect to have conversations about both professional and personal matters. morris quotes a maximal mentor who describes these conversations: “i am very close with my https://www.christinabarnes.com/ mailto:christina.barnes712@gmail.com 24 amwa journal / v36 n1 / 2021 / amwa.org knowing which button to push: communicating the value proposition of medical writing speaker robin whitsell, whitsell innovations, inc, chapel hill, nc by lisa english, phd as medical writers, it is essential to understand that everything we do communicates our value. our emails should be free of spelling and grammatical errors and highlight our writing expertise. our presentations should have well-prepared slides based on a solid understanding of the science involved. we need to show others that the document is safe with us and that they can put their confidence in us. scientific knowledge and writing expertise alone aren’t enough to do that. there is more. understanding team dynamics we need to understand our teams. to own the document, we need to influence without authority, which is challenging, especially when team members may be more senior. understanding team dynamics allows us to own any situation and shepherd the team and the document toward success. mastering our reactions it is equally important to understand what our actions might be saying to the team. to do this, we need to be observers of our reactions. try taking private notes during a meeting. when something uncomfortable happens, write it down. include only observations, no judgments. after the meeting, evaluate the information critically. understanding our feelings and how they manifest in us gives us the power to change them to improve our interpersonal effectiveness. seeking the gift of feedback what if others seem concerned about our value? in those situations, it is vital to own the disconnect and ask to reset. when seeking feedback from an individual, compliment the person on something specific and real to create a connection and confirm commitment. if the person does not provide feedback, lead them to it, explaining the behavior that’s creating the disconnect and asking to learn more. but what if the disconnect is with the team? the same basic principles hold, but it’s probably best to address it at the beginning of a meeting: “hi, it seems we’re experiencing a rough patch. i’d appreciate your advice about the best way to move forward.” putting it all together let’s look at a few stereotypical examples of team dynamics and how being aware of our feelings and mastering our reactions can help. captain obvious. what happens when a team member says something obvious? how do we feel? how do we react? understand both and then own the situation. try pulling captain obvious more fully into the conversation. ask him a question related to his expertise and make room for him to answer. the interrupter. what happens when someone consistently interrupts? often, if the interrupter is more senior, we think we must allow the behavior, but we should not. again, identify the feeling and reaction elicited. then own the situation. try practicing neutral phrases to address this situation. one example is “i promise we will get to that, jack; please, let’s complete this discussion point first.” the combative. how does a combative team member make us feel, react? owning this situation requires staying neutral, being succinct, and redirecting the individual. for example, one might say, “catherine, i hear how important this is to you. maybe we can address it in section 11. right now, we need to move to comments from clarice.” skill at leading and motivating a team although disagreeing may make us feel combative, respectful disagreement is often necessary to get the documents right. in this situation, we need to maintain a neutral tone and remain matter-of-fact. try posing the disparity as a question. for example, one might say, “it seems we are missing a source for the data on page 82. how should we resolve this?” the value proposition of a medical writer is multifold. it is about scientific knowledge and writing expertise, understanding team dynamics, and understanding (and being willing to change) ourselves. it’s about getting the document right, not being right; about conveying empathy, respect, and dedication; and about giving others the benefit of the doubt. as medical writers, we need to show up every day as our best selves to do our best work because that invites everyone to do the same. lisa english is owner and principal medical writer at just medtech, san jose, ca. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: lbenglish@sbcglobal.net mailto:lbenglish@sbcglobal.net amwa journal / v36 n1 / 2021 / amwa.org 25 what the best medical writers know about nonclinical data speaker beth krause, ms, mba, senior medical writer, rrd international, llc, rockville, md by stacie marsh, mpa, cph, gpc medical writers specialize in a variety of fields, such as continuing medical education, patient education, scientific publications, regulatory documents, and research-grant applications. writers pursuing medical writing certification (mwc) must at least be familiar with each of these areas, and even those not pursuing certification benefit from cross-disciplinary understanding. ms krause’s presentation at the amwa’s 2020 medical writing & communication conference explained the importance of nonclinical data and studies from a broad context, resonating with medical writers from all areas, including those with and without expertise in regulatory documents. overview of the drug development process the life cycle of drug development occurs through 4 phases, some of which can occur simultaneously. these include • phase i (relatively small studies focused on establishing safety, and clinical pharmacology studies), • phase ii (larger studies focused on evaluating clinical efficacy), • phase iii (pivotal, large, randomized, placebo-controlled studies with clinical trials to prove clinical efficacy prior to marketing authorization), and • phase iv (large studies to establish processes for ongoing safety and efficacy surveillance after a drug is approved and marketed). the most important function of nonclinical data is to establish that a drug is safe to be administered to humans. these data are submitted with an investigational new drug application prior to initiating studies in humans. however, the data from nonclinical studies may impact the clinical development, and thus, clinical documents, throughout a drug’s life cycle. the importance of nonclinical data in the drug development process and placement of nonclinical data in clinical regulatory documents ms krause set the stage for writers unfamiliar with regulatory documents by explaining the lifecycle of drug development within the framework of the “common technical document” (ctd) triangle (figure). endorsed by the international council for harmonisation, the ctd triangle is a standard framework for applications for approval of new medical drugs to regulatory authorities in the united states, europe, and japan. the ctd framework is organized into 5 modules. most medical writers with regulatory document expertise focus on module 5 (clinical study reports). however, the preceding module, module 4 (nonclinical study reports), includes valuable content that impacts the documents in module 5. as ms krause explained, the most important role of nonclinical information in regulatory documents is to provide basic safety support for a new chemical entity (drug) before it is tested in humans, including a detailed assessment of benefits and risks. thereafter, nonclinical information is required throughout development and marketing, including the medication packaging. nonclinical data impact risk language, dose selection, design elements, and development. for example, nonclinical studies inform risk language in clinical documents such as informed consent forms, clinical protocols, general investigational plans, and investigator brochures. nonclinical studies also predict potential side effects when it is too difficult or unethical to test in humans (ie, reproductive side effects). nonclinical data are also valuable in informing first-inhuman dose selection by establishing starting doses and safety margins, as well as dosing regimens, on the basis of findings in toxicology studies. additionally, nonclinical data inform the rest of the drug development process by determining the need for additional clinical studies, identifying potential new indications/targets, and even terminating development if the safety profile is poor. following an overview of the basics of the drug development process and the value of nonclinical data therein, figure. the ctd triangle. the ctd is organized into 5 modules. module 1 is region specific, and modules 2, 3, 4, and 5 are intended to be common for all regions. ctd, common technical document. “nonclinical data enrich the overall understanding of a drug during the development and approval process, starting well before new drugs are first tested in humans.” —beth krause session reports the ctd not part of the ctd module 2 regional administrative information module 1 clinical overview non-clinical summary non-clinical overview quality overall summary clinical summary quality module 3 non-clinical study reports module 4 module 5 clinical study reports 26 amwa journal / v36 n1 / 2021 / amwa.org jama network / ama manual of style stacy l. christiansen stylemanual@jamanetwork.org the jama network publishes more than a dozen medical journals, including jama, jama network open, and an array of specialty journals. the jama network also creates and updates the ama manual of style and publishes the users’ guides to the medical literature. in addition, the international congress on peer review and scientific publication is hosted by the jama network. the ama manual of style is a comprehensive reference for medical writers, editors, and publishers. written by jama network editors and published by oxford university press, the 11th edition has been thoroughly revised and updated. there is guidance on citing sources; data displays; grammar, punctuation, and capitalization; correct and preferred usage; abbreviations; nomenclature; ethical/legal issues and editorial policies; units of measure; and numbers, study design, and statistics. the online version is fully searchable and offers additional content, including news, quizzes for educational or training purposes, updates, an interactive calculator, and links to social-media features. for additional information, visit amamanualofstyle.com. merck & co, inc kim jochman kimberly.jochman@merck.com the merck medical writing department creates high-quality regulatory documents to support merck’s global development pipeline. we are advancing the medical writing profession by continually adapting to the ever-changing regulatory writing landscape with new technology, pilot programs with the u.s. food and drug administration, and recruitment of talent from diverse backgrounds who have the skills we need for the future. our commitment to professional development has led to the creation of a hands-on entry-level training program that leverages industry-level recommendations on the competencies and training needed to be a successful regulatory medical writer. we also ensure individualized growth opportunities, such as rotations and mentoring experiences, for our more seasoned team members. our focus on innovation and professional development allows us to drive efficiency while maintaining the highest quality. to learn more about merck’s drive to invent for a more hopeful future, along with our dedication to diversity and inclusion and our strong sense of corporate responsibility, visit www.merck.com/company-overview/. ms krause provided a detailed explanation of the role of nonclinical data within module 4. the 3 main categories in module 4 include • pharmacology (how a drug works, how a drug may affect organ systems secondary to its main target, and how coadministration of drugs may affect how they work), • pharmacokinetics (how a drug is absorbed, distributed, metabolized, and excreted from the body as well as the potential for drug interactions), and • toxicology (how a drug may cause adverse effects, including single-dose toxicity, repeat-dose toxicity, and the potential for genotoxicity and carcinogenicity). ms krause explained how to link nonclinical data in module 4 to clinical documents with which regulatory medical writers may be more familiar (typically module 5) by using a fictional example of a new chemical entity compared with a drug that is repositioned for a new indication. importance for all medical writers even medical writers who focus on other areas of medical writing, with little or no experience with regulatory documents, benefit from this presentation by its comprehensible overview of drug development and how nonclinical data fit in. although regulatory writing is a popular area of the medical writing profession, it is often limited to those with medical or pharmaceutical backgrounds or early-career experience and can be intimidating to those who specialize in other areas. the content in ms krause’s presentation is particularly salient for writers without a medical or pharmaceutical background, given the myriad aspects of the drug development and approval process that require proper placement of nonclinical data. stacie marsh is a medical writer at words for good, inc, and is based in the charlotte, nc, area. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: stacie@wordsforgood.com exhibitor precis mailto:stylemanual@jamanetwork.org mailto:kimberly.jochman@merck.com http://www.merck.com/company-overview/ mailto:stacie@wordsforgood.com https://www.amamanualofstyle.com/ amwa journal / v36 n1 / 2021 / amwa.org 27 synchrogenix, a certara company demetrius carter demetrius.carter@synchrogenix.com assuring regulatory success synchrogenix, a certara company assures and accelerates the approval of and access to medical innovations through a unique combination of customized regulatory strategy, document authoring, medical communications and publications, and operations solutions. our proven record of success is built on an unrivaled commitment to quality and compliance combined with the use of advanced technologies to enhance speed and efficiency. synchrogenix's regulatory and medical writers offer deep technical and therapeutic expertise across all submission document types to create and deliver successful documents on time, every time. our writers have authored over 200 chemistry manufacturing and controls documents, 350 nonclinical documents, and nearly 5,000 clinical documents for sponsors over the past 5 years. for more information, please visit https://certara.com/ synchrogenix. * * * university of california san diego extension robert houghtaling rhoughtaling@ucsd.edu the medical writing certificate program at the university of california san diego (ucsd) extension is designed to provide graduates with the foundational knowledge and skills needed to work as a medical writer in the commercial sector, government agencies, and/or academia. the certificate equips scientists, communication professionals, and others with a strong biomedical and/or life-sciences background to write specifically for scientific, education, or regulatory audiences and to fully understand the profession. course content is delivered in a fully online format, and students can finish the 23-unit program on an accelerated 12-month or traditional 18-month pathway. courses teach essential knowledge and incorporate real-world documents to build the foundational skills necessary for proficient medical communicators. the program culminates in an applied capstone project, which prepares students to secure professional positions as medical writers in 4 distinct specialty areas: continuing medical education materials, scientific grants, regulatory writing, and journal article and publication development. program faculty are dedicated educators and nationally recognized experts in their medical writing specialties. for more information on the ucsd extension medical writing program and our faculty, visit https://extension.ucsd. edu/courses-and-programs/medical-writing-courses. * * * oxford university press abby gross abby.gross@oup.com or linnie greene linnie.greene@oup.com oxford university press is the proud publisher of the ama manual of style, 11th edition, the must-have resource for anyone involved in medical, health, and scientific publishing. written by an expert committee of jama network editors, this latest edition addresses issues that face authors, editors, and publishers in the digital age. extensive updates include examples of how to cite digital publications, data repositories, and social media. full-color examples grace the chapter on data display, with newer types of graphic presentations and updated guidance on formatting tables and figures. the usage chapter has been revised to bring the manual up to date on word choice, especially in writing about individuals with diseases or conditions and from various socioeconomic, racial/ethnic, and sexual-orientation populations. in sum, the answer to nearly any issue facing a writer or editor in medicine, health care, and related disciplines can be found in this 11th edition. for additional information, please visit https://www.amamanualofstyle.com/. * * * thera-business consulting clare warren cwarren@therabusiness.com thera-business has been providing medical research and writing services for over 20 years. we are experts in regulatory documents, systematic reviews and meta-analyses, postmarket surveillance, and european union medical device regulation implementation. our team is highly qualified, with advanced degrees and extensive medical writing experience. we are committed to understanding your needs and providing solutions that contribute to your success. we've completed 500+ projects for leading medical-device and pharmaceutical companies, as well as government health agencies. thera-business has acquired a world-class team of experts who are capable of meeting all of your regulatory needs. we are driven and know that our work is of utmost importance to patient care! our team is detail-oriented, with the ability to work to tight deadlines. we pride ourselves on hiring the best and the brightest! mailto:demetrius.carter@synchrogenix.com https://certara.com/synchrogenix mailto:rhoughtaling@ucsd.edu https://extension.ucsd.edu/courses-and-programs/medical-writing-courses mailto:abby.gross@oup.com mailto:linnie.greene@oup.com https://www.amamanualofstyle.com/ mailto:cwarren@therabusiness.com 28 amwa journal / v36 n1 / 2021 / amwa.org whitsell innovations, inc, connie morris connie.morris@whitsellinnovations.com whitsell innovations (wi), inc, is a woman-owned, full-service medical and scientific writing company focusing on the needs of the pharmaceutical, biotech, and device industries. we speak science. we are a team of experts who deliver high-quality medical, scientific, and regulatory writing. wi is a boutique group composed of individuals with years of experience, in both industry and medical writing, and most with advanced degrees at the doctoral level. our subject-matter expertise capitalizes on our education and our deep industry experience. we integrate with your team. our broad range of services meet the needs of our expansive client portfolio, ranging from small us-based clients to large international clients. wi offers a uniquely integrated approach for communicating complex corporate and scientific data and ideas. we seamlessly engage with client teams to ensure successful progress and completion of each project. we focus on perfection. our experience and training allow us to pay attention to every detail. our singular focus is perfect medical, scientific, and regulatory writing with clarity, reliability, and integrity. we are whitsell innovations. we speak science and we love what we do! https://www.whitsellinnovations.com * * * perfectit daniel heuman daniel@intelligentediting.com all it takes is one typo for readers to question the accuracy of a submission or publication. you can spend hours searching for each typo manually. or you can use perfectit™ to help find consistency mistakes and other common typos faster so you can focus on the science. perfectit is used by thousands of medical writers and editors around the world, including the medical writing teams at six of the world’s top ten pharmaceutical firms. amwa members voted it one of their most essential tools. get the free trial for ms word today: https://intelligentediting.com * * * trilogy writing & consulting magnolia correa magnolia.correa@trilogywriting.com at trilogy, medical writing is our passion. as specialists in clinical and nonclinical regulatory documentation, we provide a service that is more than just writing. our writers are integral parts of our clients’ teams, proactively planning, coordinating, and writing their clinical documents to meet timelines, with a readability that reduces the time for review and approval. we have been helping our satisfied customers— pharmaceutical companies and clinical research organizations of all sizes, worldwide—to streamline their documentation processes for over 18 years. trilogy currently has more than 65 writers, who are located in europe and north america. we pride ourselves on our “dedicated team” approach when developing documents, which greatly reduces the time needed for production and ensures much greater levels of continuity throughout an entire development program. we are happy to take on any project, from individual documents to supporting an entire clinical-development program. please get in touch with us to find out how we can support your clinical and nonclinical teams with their document needs. https://www.trilogywriting.com/ contact marketing@amwa.org for information about exhibitor and sponsorship opportunities. plan to share your products and services at #amwa2021 mailto:connie.morris@whitsellinnovations.com https://www.whitsellinnovations.com mailto:daniel@intelligentediting.com https://intelligentediting.com mailto:magnolia.correa@trilogywriting.com https://www.trilogywriting.com/ mailto:marketing@amwa.org v37 n2 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 30 abstract demand for qualified medical writers is high and expected to continue to grow. with competition for experienced writers getting fierce, the need for alternative pools of talent has become evident. this article describes a pilot internship program developed at an independent clinical and regulatory consulting company designed to allow an alternate path for entry into the field of medical writing and to foster and retain talent. the internship will provide novice writers with relevant training, connections, and job experience to aid in attaining a position in regulatory writing. we discuss the challenges and opportunities discovered during the inaugural internship year and provide lessons for developing an internship program. demand for qualified medical writers is high and expected to continue to grow, with the global medical writing market expected to reach 7.7 billion us dollars by 2027.1 this market growth is driven in part by increasing investments in research and development by pharmaceutical companies and the rise in contract research organization outsourcing.1 despite the demand for medical writers, there are few degree or professional development programs that prepare students directly for medical writing. existing training programs comprise a combination of degree and certificate programs and include the american medical writers association (amwa)'s essential skills certificate program, the university of california san diego extension's medical writing certificate program, and the university of chicago's medical writing and editing certificate program. although these programs are useful for building technical knowledge, they often do not provide students with training in the soft skills or practical skills necessary for day-to-day work as a medical writer, including project management, professional communication, emotional intelligence, time management, and conflict resolution (figure 1). medical writing and the biotechnology industry generally have been experiencing a significant degree of staff turnover as part of the “great resignation” phenomenon that has followed the economic turmoil of the covid-19 pandemic.2 this competition for top talent, combined with significant growth, has left the biotechnology industry looking for ways to increase interest in the field, create alternate tracks for entry, and retain talented employees. these include mentoring college students interested in science, technology, engineering, and mathematics careers, hiring a shoe in the door: regulatory writing internships for promoting diversity and building the talent pool jordan e. sedlacek, dvm, mph, magr and jeanette m. towles, ma, rac-drugs / synterex, inc., dedham, ma editor-at-large figure 1. key attributes of successful medical writers. figure previously presented at amwa new england brunch roundtable meeting, march 21, 2021. detailoriented organized/ disciplined creates and maintains plans or timelines identifies tools and processes to gain efficiency perceptive intuits where in the team lifecycle he/she is producing a document finds creative solutions to related challenges proactive outlines team vision for document analyzes project plan and identifies risks and mitigations curious keeps up to date with latest regulations and standards builds therapeutic or regulatory knowledge base for team flexible gives flexibility when possible communicative communicates firmly when flexibility not possible collaborative builds relationships with other departments forges alignment advocates te ch ni ca l s ki ll so ft sk ill (e i) http://www.amwajournal.org amwajournal.org 31a shoe in the door: regulatory writing internships foreign-born talent, and developing a robust corporate culture of inclusion.3 many job positions in medical writing require multiple years of industry experience. a search of job postings on april 26, 2022, on indeed.com for entry-level medical writing positions found that 14 of the first 15 listings required either an advanced degree (master's or above) or more than 1 year experience; 7 of 15 required both. one job listing did not specify experience requirements. as is true for other medical writers in the field who are advanced in their careers, the senior leaders in our consultancy benefited from colleagues who were willing to provide mentoring early in their careers, which has engendered a sense of corporate responsibility in contributing to the development of the next generation of medical writers. thus, synterex has developed a medical writing internship program to foster new professionals and help medical writers enter the field of regulatory medical writing. synterex partnered with a local agency promoting engagement in the life sciences for massachusetts residents to create an in-house medical writing internship. this program provides sponsorship for 2 students from local colleges and universities. two additional students may be sponsored if chosen from an associate degree program or from historically black colleges and universities (hbcus). our findings from the first year of the internship program indicated that the internship provided a potential pipeline for talent acquisition and retention. we hope that this outline of our experience may serve as a base model for implementation of an internship program for companies of any size considering starting a program and will lower the barriers for entry into the field for medical writers, in particular those from diverse backgrounds and historically disadvantaged communities. methods in early 2021, our team observed that there was a concurrent increase in requests from associates of staff and consultants for mentoring and tips on how to enter the medical writing field, a higher demand for medical writing resources, and fewer contract medical writing resources available for ad hoc projects. although historically we had not hired many entry-level medical writers due to the fast pace of the work and lack of demand from clients for medical writers with less than 5 years of experience, we began thinking of ways we could expand the medical writing talent pool in the long-term to eventually align client demand with interest from entry-level potential candidates. in may of 2021, our executive leadership team initiated development of an internship program. the team discussed goals and gathered requirements for the internship program, including • the scope of the program: did we want the internship to be focused on just medical writing, or would we open it up to other business functions? • the geography of the program: did we want a national search, or did we want to anchor the program near headquarters? • the logistics of the program: did we want a program that had a database of candidates we could search, or did we want applications to come directly to us to vet? did we want to consider only students studying medical writing, or would we consider students studying in adjacent scientific fields? ultimately, we decided that we wanted at least one of the intern roles to be open to it and business operations in addition to medical writing because we felt providing opportunities on those sides of the business would be equally beneficial for potential internship candidates as well as being areas of the clinical trial talent pool that also need development and that may have potential employment needs in our company in the future. we also decided to anchor the internship program at our headquarters in massachusetts, given the high concentration of our clients and staff in the state and the potential for in-person interaction (pandemic permitting) within our primarily virtual workforce. in addition, given that we wanted to ensure our first internship program would be successful and manageable in scope because we are a company comprised largely of working subject matter experts with lean administrative/ operational staff to vet applications, we opted for a program that had an existing database of interns we could search. although this may present some limitations because the database is finite and not tailored to our core services, we felt this would be more manageable for us in the timeframe given to start up the internship program. lastly, for medical writing interns, we opted to search for students in any scientific studies and try to identify writing-related or clinical trial-related experience or interests on their profiles, rather than limit our search to only medical writing-related applicants, as we did not want to bias our resourcing pool to those students who already had exposure to medical writing as a career choice. in selecting an institution to partner with for internships, we wanted to select one that would be consistent with our hiring goals as a woman-owned and disability-owned http://www.amwajournal.org amwajournal.org 32a shoe in the door: regulatory writing internships business in terms of making sure that our workforce represents the people who will ultimately receive the medicines we work on. massachusetts life science center’s (mlsc) internship challenge program appealed to our mission because this program provides sponsorship of up to $8,160 ($17 per hour for up to 12 weeks) for 2 students from local colleges and universities as well as 2 additional students if chosen from an associate degree program or from hbcus. massachusetts, where our headquarters is, has a particularly robust life science industry that provided us with multiple partner organizations to consider. these partnership opportunities may vary in areas with less biomedical infrastructure. a full-time employee was identified to act as the internship coordinator. this person acted as the main contact for the intern to answer questions and direct programming. in our case, a junior staff member was chosen as someone who was able to relate to recent entry into the field. this team member also had more availability for ad hoc meetings, questions, and hands-on direction. the internship coordinator then applied to the mlsc internship challenge program and searched in their database for intern candidates who would fit our consultancy’s needs (educational background in the life sciences or information technology, career goals in line with our areas of expertise, experience with relevant software systems, etc). any student who meets the mlsc program requirements of massachusetts residency and enrollment in an accredited college or university in massachusetts or at an hbcu can submit a resume and cover letter to the program database for companies to search. six potential applicants were identified for each internship, and the executive team reviewed their application materials. none of the medical writing internship candidates were from associate degree programs. two of the it internship candidates were from associate degree programs. the internship coordinator reached out to one applicant for the medical writing position and 4 applicants for the it position and signed formal agreements with the medical writing intern who confirmed her interest in the program. none of the it applicants contacted chose to pursue the internship opportunity. a single intern was hired for our pilot internship season. the intern was selected for her interest in pursuing regulatory writing professionally and her educational background in a regulatory affairs master's program. she was assigned to work 40 hours per week for the 12-week period with pay sponsored by the mlsc internship program. the executive leadership team worked with the internship coordinator to develop a curriculum that involved meetings and shadowing sessions to pair the intern with team members in various departments. this allowed the intern exposure to various facets of the business (figure 2). we also agreed on critical success factors for the internship, including • exposure to the concept of peer review and feedback, • review and tips on developing their cvs for future opportunities, • practicing summarizing medical content (eg, a regulatory guidance of interest), • practicing public speaking (eg, discuss a science-related webinar they attended), and • general work tips and day-to-day expectations for how to work and communicate in an office environment. the internship coordinator set up an orientation to convey these success factors, our company values and organizational structure, and expectations to the intern. the internship coordinator also set up a microsoft teams channel in which the extended team could create a queue of projects that would be both appropriate for the intern to work on and meaningful in terms of gaining experience. we also sent a company-wide email introducing the intern so that the wider team could get to know and connect with her. the intern was invited to weekly business operations meetings and assigned various internally facing projects such as the development of a company style guide. the intern was also assigned to externally facing projects with the supervision of a staff medical writer including social figure 2. components of the pilot internship. http://www.amwajournal.org amwajournal.org 33a shoe in the door: regulatory writing internships media blog posts on health-related projects. these projects allowed the intern to gain experience with professional writing tools and reference citation management software. although the intern did not work directly on client materials, she was involved as an observer in several active documents with advance permission from the client and an active nondisclosure agreement. this allowed the intern to experience the collaborative authoring process and comment resolution meetings. after the meetings, the intern met with the internship coordinator to discuss professional communication and conflict resolution tools. at the beginning of the internship, an exit interview was put on the calendar with the intern, as well as prospective regular meetings with select other team members to discuss specific business functions outside of the medical writing function. in addition, our own impressions and reflections on the internship were discussed at a regular internal meeting at the end of the internship period. the intern completed training in good clinical practice and our company standard operating procedures. our intern provided feedback at her exit interview on the aspects of the program that worked and things that could have been done better. this feedback is reflected in the lessons learned section below. lessons learned consider work environment our company is a fully remote workplace, with team members spread across the united states. this remote set-up may be an advantage for interns from areas without a developed biotechnology industry or for individuals without reliable transportation to and from work. the remote workplace can present a challenge, however, as the intern will not organically get to meet the team in the course of their work, and at this juncture in their career development they most likely do not have existing in-office experience to draw from to make their own connections. we had to go out of our way to encourage team members to interact with the intern and to include her in ongoing projects. when hiring interns for remote work, recognize that in order to participate fully, interns may need to be provided with laptops and other tools to access company resources. setting expectations it is important that both the intern and the company set realistic expectations at the beginning of the internship both in terms of requirements and availability. although our intern had 40 hours of availability in the week to dedicate to the internship program, it was understood and agreed at the outset that she also had a part-time job and a capstone project that cut into some of our regular business hours. this arrangement may not be feasible for all companies and all individuals, as it puts the onus on the intern to communicate their availability and the hosting company to work around it. have a frank conversation with the intern prior to hiring on the expected hours and commitment that will be required in order to provide real, meaningful work for the company. in retrospect, we decided to make a formal job description for the internship position to state these expectations in writing. recognize that if your internship requires full-time hours but does not provide a living wage or benefits, many individuals will need to maintain outside employment. restricting outside concurrent employment or expecting interns to work for experience rather than pay will limit applicants to only those privileged enough to be supported by family or external means. the more you are able to invest in your intern, the more they will be able to invest in your company. provide depth and breadth in programming we found success with assigning the intern a mix of group work and independent projects. this allowed her to stay busy while allowing for feedback from other team members on rotations through each department. having a long list of possible tasks, longer than you think you will need, ensures that the intern has other work to focus on if the internship coordinator is not immediately available to direct the intern to a new project. try to identify independent, low-pressure tasks that are conducive to skill-building. we assigned our intern to writing blog-style health posts for our social media site. we challenged her to write the piece for different audiences (graduate level peers, high school students, children) and to bring the reading level of her work within range for each group. these assignments also allowed her to also practice using citation management software in a low-risk environment before applying those skills in a client-facing document during collaborative authoring. a limitation of our program was having only one intern in our pilot program. in the future, we hope to host a cohort of interns at the same time. this would allow for more group work and collaborative learning between interns of similar skill levels. provide resources for learning in order to facilitate independent work from your intern, curate resources for self-guided learning. note that many of these resources already exist and do not need to be created in-house. there is a wealth of tutorial videos available on http://www.amwajournal.org amwajournal.org 34a shoe in the door: regulatory writing internships the internet for the different software systems typically used in medical writing. online training modules are available through amwa and the dia (see additional resources) provide regulatory guidance documents for the intern to review. if you can show a redacted example completed document similar to the one under development, this will allow the intern to build context for the current assignment. consider building a library (analogue or digital) for your intern and other staff members to peruse. try sending your intern on an internet search for additional resources on a certain topic; you may be surprised at what useful tools they are able to bring back to the team. allow time for feedback and questions after periods of independent and group work, it is important to allow the intern time to digest and process the learning experience. we established a standing weekly meeting between the intern and the internship coordinator to discuss recent work. we also planned weekly meetings with each department to allow for broader exposure to the company. given how busy team members are, it is strongly recommended to set these meetings up in advance so that programming for the intern can be prioritized. we were limited in the quick development of our internship program, and more advanced planning would have allowed for a more regular meeting schedule. not all assignments have to be directly related to medical writing medical writers often wear many hats in the course of their normal work. foster these adjacent skills in your interns as well. provide time to discuss soft skills such as professional development, time management, and remote working strategies. interns may have little experience with professional workplaces. recognize that you may need to discuss and model professionalism in written and verbal communication as well as business etiquette. this may take the form of role-playing professional communication and conflict resolution scenarios. consider offering training in emotional intelligence courses that will serve the intern in their future career, regardless of what they pursue. consider future benefit to the intern try to provide the intern with experiences that will not only benefit the company but will benefit the intern going forward. this may take the form of resume-building experiences such as authorship or editing credit, industry connections for future professional development opportunities, or, more tangibly, a position within your company if possible. we had a very positive experience with our first intern, and we were able to hire her into a part-time project management position while she completed her graduate degree. she now works for us as a full-time employee. she has been able to smoothly transition into these new roles due to her previous experience during her internship and was able to make an immediate impact on our team. if you are not able to hire your intern, consider remaining in contact so that you can continue to provide mentorship, advice, or job references after the internship is complete. plans for future internship development we found our pilot internship program a resounding success. we are looking to expand the program in 2022 to take on multiple medical writing interns and have developed a pilot information technology internship position as well. we are looking to partner with other local life science outreach programs to reach a more diverse student base of first-generation college students. we also hope to partner directly with local colleges and universities to identify interested students. many students plan their summer and semester experiences months in advance, and it is important to get your internship information to them early if you would like to be considered. in the future, we would like to expand outside of our local area to partner with hbcus, tribal organizations, and international student groups to cast a wider net for our internship candidates and provide opportunities for entry into medical writing to communities that have previously been under-represented. building on the success of our internship program, we are also developing a fellowship program to function like a medical writing apprenticeship. this program would be longer-term, a full year as compared with the 12-week internship. the fellowship is targeted to individuals who have completed an advanced degree in life sciences within the previous 2 years. this program provides a full-time, benefited fellowship position for individuals who are committed to entering the medical writing profession but do not have relevant job experience for entry-level positions. additional resources dia learning solutions: https://www.diaglobal.org/ en/learning-solutions amwa courses: https://info.amwa.org/medicalcommunication-essential-skills-for-success http://www.amwajournal.org https://www.diaglobal.org/en/learning-solutions https://www.diaglobal.org/en/learning-solutions https://info.amwa.org/medical-communication-essential-skills-for-success https://info.amwa.org/medical-communication-essential-skills-for-success amwajournal.org 35a shoe in the door: regulatory writing internships conclusions given demand for experienced medical writers and the dearth of qualified applicants, we have presented a basic model that smallto medium-size companies can customize to develop an in-house training and internship program to attract and retain medical writing talent from a diverse background. author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. author contact: jsedlacek@synterex.com references 1. grand view research. medical writing market worth $7.7 billion by 2027 | cagr: 10.9%. grand view research website. published april 2020. accessed february 9, 2022. https://www. grandviewresearch.com/press-release/global-medical-writingmarket 2. lahucik, k. 2022 forecast: talent war in life sciences, salary inflation in c-suite builds to 'negative feedback loop'. fierce biotech website. published december 22, 2021. accessed february 9, 2022. https://www.fiercebiotech.com/biotech/2022talent-war-life-sciences-salary-inflation-c-suite-builds-tonegative-feedback-loop 3. massbioed. key insights from breakout sessions. 2021 massbioed life sciences workforce conference; august 2021; cambridge, ma. accessed february 9, 2022. https://www.massbioed.org/ wp-content/uploads/2021/08/2021-life-sciences-workforceconference-breakout-group-summary.pdf macro and micro: taking editing all the way from measurement to meaning. save over 15% when purchasing as a package! find it now in amwa online learning www.amwa.org/online_learning ensure a clear message with credibility and clarity. macroediting helps an author speak with credibility and clarity. the process works to ensure a clear message with congruent parts, coherent information, and a unified focus. create high-quality scientific documents with the essential components of macroediting and gain the “bird’s eye view.” macroediting produce the desired effect with accuracy and intention. microediting dives into the details by requiring a close analysis of a text’s smallest building blocks: words, phrases, sentences, and paragraphs. this process makes the paper easier to read, factually and grammatically sound, and more likely to produce the desired effect on its audience. microediting http://www.amwajournal.org https://www.grandviewresearch.com/press-release/global-medical-writing-market https://www.grandviewresearch.com/press-release/global-medical-writing-market https://www.grandviewresearch.com/press-release/global-medical-writing-market https://www.fiercebiotech.com/biotech/2022-talent-war-life-sciences-salary-inflation-c-suite-builds-to-negative-feedback-loop https://www.fiercebiotech.com/biotech/2022-talent-war-life-sciences-salary-inflation-c-suite-builds-to-negative-feedback-loop https://www.fiercebiotech.com/biotech/2022-talent-war-life-sciences-salary-inflation-c-suite-builds-to-negative-feedback-loop https://www.massbioed.org/wp-content/uploads/2021/08/2021-life-sciences-workforce-conference-breakout-group-summary.pdf https://www.massbioed.org/wp-content/uploads/2021/08/2021-life-sciences-workforce-conference-breakout-group-summary.pdf https://www.massbioed.org/wp-content/uploads/2021/08/2021-life-sciences-workforce-conference-breakout-group-summary.pdf v37 n1 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 54 everyday ethics abstract writers working in industry and contracting are often involved in the writing of technical content marketing for products, services, and personal freelance businesses. in this article, writers in technical industries are introduced to the legal and ethical issues of technical content marketing and advertising, which covers intellectual property, truth in advertising, comparative and competitive advertising, and customer reach. the goal of this article is to provide writers with a better understanding of these legal terms and concepts as well as ethical issues that influence technical content marketing strategy and practice. marketing copywriters in technical industries create technical content marketing for the commercialization of technology and for promoting personal freelance businesses. as rebecca geier states, “content is the heart of your inbound marketing program. it’s how new people find your company from searches, it educates prospects and...ultimately it builds trust between your business and your prospects and customers.”1 although the writing of marketing copy, marketing genres, tactics, and communication technologies are familiar to copywriters in technical industries, many of the legal and ethical issues and restrictions that influence the decision process are less familiar and often based on word-of-mouth advice from others in these fields. technical content marketing writers and strategists often encounter internally and externally written marketing copy that may cause liability for the writer or organization and may be considered unethical practice. this article examines 4 categories of legal and ethical issues in technical content marketing—with many issues also of concern to freelance writers managing their own business. the 4 categories of legal and ethical issues in technical content marketing, which encompasses content creation and distribution include • intellectual property, • truth in advertising, • comparative and competitive advertising, and • customer reach. the goal of this article is to examine these 4 categories of legal and ethical issues that influence content marketing practice in the commercialization of technical products and services. intellectual property one of the pivotal cultural differences between business executives and medical/technical (or scientific) experts is the practice and attitudes associated with information sharing about technology. specifically, science and technology have a 350-year-old philosophical and ethical tradition of “open science,” which is the free exchange of information for the improvement of society.2-5 notably, robert merton describes the culture by stating, “the pursuit of science is culturally defined as being primarily a disinterested search for truth and only secondarily, a means of earning a livelihood.”6 however in the context of marketing copywriting, the technology becomes the product rather than medical, scientific, or technical knowledge and this shift transforms the cultural norms associated with the sharing of information and protection of intellectual property.7 often the scientific and technical information is concealed or selectively disclosed by companies in order to maintain a competitive advantage over competing organizations.4,7-10 organizations protect their technology or intellectual property through use of patents and trade secrets. a technology patent allows commercial organizations to be the sole commercial provider of an innovative technology (a monopoly) for a period of time in the jurisdiction covered by the granting office. for example, in the united states and europe, most patents are granted for 20 years, which is considered sufficient time for organizations to recoup the costs of research, development, and commercialization.11,12 for many medical, scientific, and technical fields, 20 years is generally longer than the market lifetime of most new products. the intent of patent protection is to enable companies to disclose detailed information about a scott a. mogull, phd / texas state university, san marcos, tx legal and ethical issues in technical content marketing http://www.amwajournal.org amwajournal.org 55legal and ethical issues in technical content marketing technology for customer use while protecting sales of novel technologies. although technical content marketing writers often avoid revealing detailed information about novel technology, much of this technical information is publicly available in us patents, which are typically published and available 18 months after the filing date. thus, withholding technical information in technical content marketing generally imposes a greater hinderance and annoyance to technical consumers (for example, physicians or patients) than competitors who are familiar with researching patents as well as the scientific literature to understand patented or researched innovations. the second form of protection, trade secret, is information about a technology or manufacturing process that has been developed by an organization and is protected through withholding proprietary information from individuals outside of an organization. in general, trade secrets worth protecting are those that have some commercial value, which may include an innovative process manufacturing process a technical product rather than the technical product itself. many trade secrets are not eligible for patent protection, so, in contrast to patented technologies, trade secrets inadvertently divulged technical content marketing would undermine this competitive advantage. many organizations require employees and contractors to sign a nondisclosure agreement (nda) or a confidentiality agreement that places an individual personally liable for information divulged. aside from trade secrets, marketing copywriters in technical fields may find that sharing technical product information in technical content marketing helps construct the ethos of an organization and create a positive brand image. in particular, this sharing of information is most important to technical consumers in the early market, who have a strong curiosity and interest to understand technical innovations.13 this sharing of technical information is often a concern for marketing copywriters in technical industries who typically provide relevant details, such as detailed understanding of molecular actions and results from clinical trials in patient communication. apart from aristotelian persuasion strategies and consumer needs for information, copywriters of technical content marketing also need to consider the legal obligations of providing information that is necessary for the safe use of a product. truth in advertising in the united states, as well as the european union and many other regions, advertising (as well as all forms of marketing or advertising) is legally required to14-16 • be truthful and nondeceptive (in any part or as a whole) and • have evidence to support objective statements of fact (using appropriate and widely accepted methods of collecting such evidence). any marketing content that is inaccurate, misleading, or unproven is considered false (or deceptive) advertising and is subject to legal action against an organization or freelancer. in technical content marketing, the most relevant considerations are to ensure the truth and accuracy of all content. as mentioned previously, both the expressed and implied claims (or factual, objective statements) in marketing must be accurate and supported by evidence. furthermore, the overall context of the text and document (including visuals) must not be misleading to a “reasonable consumer” as interpreted by regulators.15 at the simplest level, any expressed claim, or one that is explicitly stated, must be accurate and truthful. for example, the united states federal trade commission (ftc), the governmental organization that monitors most forms of advertising in the united states, provides the following example of expressed claim, “abc refrigerators will reduce your energy costs by 25%.”15 in contrast, an implied claim is made indirectly or by inference, such as, “abc mouthwash kills the germs that cause colds.”15 according to the ftc, a “reasonable consumer” could make a logical connection between these 2 statements in an implied claim and conclude that the mouthwash will prevent colds.15 in this example provided by the ftc, the writer’s intent is to mislead readers and imply the use of a particular product (mouthwash) would be a useful product for treating colds. by law, both expressed and implied claims must be verified by scientific evidence using appropriate investigation methods. another realm of concern is personal experience or customer anecdotes (especially for health-related claims), which are not considered appropriate evidence to support these types of claims.15,16 subjective claims made by a company are more difficult for the ftc to evaluate and often receive less scrutiny.14,16,17 thus, overstated subjective claims, or “puffery”, are relatively prominent in consumer advertising.16 in many cases, simply stating that a product is “the best” is typically ignored by the ftc.16,17 yet subjective claims also may be subject to penalty depending on the claim and the impact that such statements have on the overall impression of the communication. for example, a statement would be false advertising if it contains any unsubstantiated, objective element, such as “most consumers prefer xyz.”16 subjective statements are evaluated in context and technical content marketing would http://www.amwajournal.org amwajournal.org 56legal and ethical issues in technical content marketing be considered false advertising if such statements contributed to an overall misleading impression in the mind of the consumer. another form of subjective claims is those from individuals rather than claims from a commercial organization. subjective claims from individuals, called endorsements or testimonials, must be an honest opinion and detail the actual experience of the individual. additionally, endorsements must reflect the typical customer experience rather than unusual cases. the ftc emphasizes that simply stating “results may vary” for an atypical case is not considered sufficient disclosure to avoid legal penalty for misleading advertising.15,16 furthermore, an individual providing an expert endorsement must have appropriate qualifications to be considered an expert in an appropriate field and provide a relevant opinion focusing on the key applications of the product. in many regions (including the united states), testimonials must be clearly qualified with a statement of disclosure if provided from any individual that has a personal or financial relationship with an organization. such disclosure, as well as any disclaimer that qualifies a claim, must be presented in plain language and displayed conspicuously to avoid misleading readers. despite these legal requirements, marketing and advertising have long been pushing the boundaries of truthful statements and are generally perceived cynically, fairly or unfairly, as persuasive and deceptive communication with exaggerated claims that are designed to mislead naïve consumers.18-23 furthermore, marketing content is prohibited, by law, from deceiving or misleading customers through the omission of relevant (or “material”) information that is important for influencing a “reasonable consumer” to purchase or use a product.16 furthermore, ethical technical content marketing includes completeness, so claims are not misrepresented or misinterpreted by the omission of relevant detail.23 such perceptions and unethical practice undermine consumer trust and confidence in all forms of marketing communication and organizations. therefore, to compensate for inherent audience skepticism and distrust, content writers should prioritize direct (explicit), objective, accurate claims and provide complete evidence and description of methods used to collect for the determination of each claim. ultimately, a detailed and honest independent expert analysis may be particularly persuasive for technical consumers. comparative and competitive advertising in addition to providing accurate and honest information about a product, technical content marketing—particularly for pharmaceuticals and medical products—is often responsive to competitors’ generic drugs or treatments.24 comparative advertising is technical content marketing that compares a company’s product to another product— often one from a competitor—either explicitly by stating the brand name of a competing product, or implicitly through reference (such as “brand x”). despite common misconceptions about comparative advertising that have arisen from outdated laws and industry norms, both explicit and implicit competitive advertising are legal in the united states, the united kingdom, and the european union.25-27 in fact, the ftc encourages comparative advertising because it provides “important information to consumers” by helping them distinguish between product features and also encourages product improvement and innovation.25 comparative advertising is legal as long as it adheres to the following conditions:25,26,28 • it provides truthful information that is not misleading in part or in whole. • it compares equivalent products that meet the same customer need or are intended for the same purpose. • it objectively compares one or more relevant product performance features that can be scientifically verified with appropriate evidence. • it excludes any other distortion or misleading information. • if explicit, it properly identifies competitor(s) by using the exact trade name, trademark, or other distinguishing branding marks so the trademarks (not the products) are not denigrated or discredited. under these conditions, comparative advertising is legal and the courts have consistently denied any claims of defamation (or libel) by competitors.26,29 comparative advertising is an effective strategy for introducing new products, distinguishing similar products, and establishing a niche in the market.30-32 yet some advertisers consider comparative advertising to be unethical and risky, as it may increase the likelihood of complaints about a company’s advertising to the ftc (or other regulatory organizations) as a punitive response by competitors.29 customer reach much of marketing strategy is driven by profit rather than the effects that it has on individuals and particular groups. of particular concern, content writers should be conscious of development and delivery of information to specific, overly narrow target consumers at the exclusion of other consumer groups.33-35 particularly in business-to-consumer (b2c) advertising, a historical bias has been writing, http://www.amwajournal.org amwajournal.org 57legal and ethical issues in technical content marketing designing, and delivering marketing communication disproportionally toward affluent target markets in industrialized western countries.34-36 however, a contrasting situation may also be the case as some b2c advertising has been criticized for specifically targeting economically disadvantaged groups and developing nations with advertisements for harmful products such as cigarettes or infant formula instead of breastmilk.37-39 aside from the numerous examples and case studies of biased b2c marketing practices that tend to reduce the market and prevent a product from achieving full market potential, the focus of this discussion is to identify ethical marketing practices so writers can avoid such problems and maximize connection with customers within legal and ethical customer reach. the most effective strategy for identifying target consumer audiences or a specific market is to characterize potential consumers by providing technical marketing communication focusing on the relevant needs or wants that are addressed by the product.40 such an audience analysis should downplay or exclude personal attributes that are unrelated to the product need, which would create a distorted or biased characterization of a target audience that would unnecessarily influence marketing communication strategy. in technical content marketing, different groups of audiences (or buyer personas) are identified and served through a collection of content that is targeted to their specific (often differing) needs or wants.41 buyer personas may not specifically be a direct “buyer” or purchaser of a product or service, but each group contributes to the business model of the organization. a common example are company websites, which are organized into sections around the needs of different groups providing resources to address their specific need for information. with a buyer persona strategy, the first layer for organizing a website is to direct individuals from different groups into the proper section of resources. in particular, consider the american medical writers association (amwa) journal’s homepage (figure), which provides links to buyer personas to • “contribute,” for writers to prepare manuscripts for the journal, • “advertise,” for advertisers to promote a product or service to the readers, or • “find,” for readers to search a database of articles within the journal. in this example, specific content of each section of the website provides relevant information that supports the informational needs of these different groups in order to support the publication of the journal. additionally, technical markets are international—both as global markets as well as domestic markets with many customers originally from other nations. from a writing and accessibility perspective, the most effective technical content marketing is designed for global audiences. from a communication lens apart from country-specific content regulation, technical content marketing writers can improve communication effectiveness with non-native english speakers by adhering to the following guidelines42-44 • use deductive organization with topic sentences and important information at the beginning of each document, section, and paragraph, figure. example of buyer personas (or target audiences) of common visitor categories to the amwa journal’s home page. sections of the journal website are targeted to specific audiences, such as “contribute” for individuals interested in writing an article for the journal, “advertise,” for individuals seeking to advertise within the journal, and “find,” for individuals seeking to find and read an article published by the journal. collectively, these buyer personas represent the major constituents of the publication. this figure has been reprinted with permission from amwa. http://www.amwajournal.org amwajournal.org 58legal and ethical issues in technical content marketing • use plain language, concise phrases, short sentences, and the active voice; limit the use of long, complex sentences and avoid negative constructions, • use international measurements (the metric system), • use a consistent (or controlled) and precise vocabulary based on word denotation and concrete language rather than colloquial words and phrases with embedded connotations (eg, change the colloquial verb phrase “looking into” to the single verb “investigate,” which expresses the intended concept clearly and translates directly), and • use clear and specific statements rather than using culturally specific metaphors or figurative language (eg, change the us–centric baseball reference “home run” to “success”). not only will these strategies increase the effectiveness of communication to global audiences in english, but these techniques will also facilitate accurate translation into other languages. finally, although customer reach is also achieved through the use of technology to deliver technical content marketing, the latest technology may impose communication barriers to some audiences, particularly individuals with disabilities as well as those with older technology or low-bandwidth connections.45-48 for many technologies, using the latest communication platforms to communicate with affluent, able-bodied, mainstream consumers may prevent communication to a target audience and individuals from other groups. particularly in regards to accessibility, or inclusion of alternative communication formats for individuals set apart by the digital divide, such communication may be a legal consideration in the united states, europe, and many other countries.49 yet, technology does not always prevent access but, in many cases, also facilitates communication to these groups (for example, youtube will close caption videos by default for the hearing impaired). the challenge with using the latest communication technology is that the barriers and adaptations are technology specific and constantly shifting. the important point for marketing writers is to provide content in appropriate formats for the widest coverage of potential customers. conclusion in this literature review, the goal has been to introduce medical writers to the legal and ethical issues of marketing in which additional caution is needed. as a review, this article is designed to serve as a foundational resource with reference to sources for further information and clarification of individual issues. the importance of further researching additional issues depends on the nature of each situation. in particular, the ethical practices of technical content marketing writing and the commercialization of technology are developed from legal and academic sources, which advocate for communicating content rather than rhetorically persuasive strategies. much of this discussion touches on legal issues and interpretations, which are constantly in flux. in regard to issues with legal implications, specific laws and regulations vary by geographic region and change as new technologies enable novel marketing practices and lawmakers make changes to prior regulations. thus, specific marketing and advertising copywriting encroaching on legal issues presented within this article require consultation of the latest legal postings and review by attorneys familiar with the jurisdiction in order to evaluate the appropriateness of decisions made by the technical content marketing writer or strategist. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: mogull@txstate.edu references 1. geier r. smart marketing for engineers: an inbound marketing guide to reaching technical audiences. rockbench publishing; 2016. 2. david pa. from keeping “nature’s secrets” to the institutionalization of “open science.” in: ghosh ra, ed. code: collaborative ownership and the digital economy. mit press; 2005: 85-108. 3. mogull sa. scientific 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http://dx.doi.org/10.2307/41165133 http://dx.doi.org/10.2307/41165133 http://dx.doi.org/10.1108/ejm-09-2011-0515 http://dx.doi.org/10.1108/ejm-09-2011-0515 http://dx.doi.org/10.1109/47.968105 https://dx.doi.org/10.1145/588646.588725 http://dx.doi.org/10.1108/07378830210452613 http://dx.doi.org/10.1108/07378830210452613 amwajournal.org 26session reports the quick and the dirty: best practices for writing and editing under tight timelines speakers j. kelly byram, ms, mba, els, immediate past president and director-at-large for new mexico, amwa southwest chapter, freelance editor and writer, owner of duke city consulting, llc, albuquerque, nm theresa e. singleton, phd, 2021 amwa fellow, freelance scientific writer, owner of singleton science, llc, beverly, ma damiana chiavolini, ms, phd, president-elect of amwa southwest chapter, academic writer, editor, and instructor, richardson, tx by stephany panlilio, ms in medical writing, the scope and timeline for documents varies, depending on the type of document and the client for which the document is being prepared. however, these 2 aspects determine a medical writer’s ability to take on a new project. this article summarizes the experiences of ms byram and dr singleton as freelance medical writers and editors, and dr chiavolini as a medical writer and editor in academia, and their best practices for writing and editing under tight timelines. tight timelines versus short notice it is important to first differentiate between a tight timeline and short notice. in some cases, a client can reach out requesting help with a project, but the expectation is the project starts right away. this is short notice. on the other hand, a client may reach out ahead of time, but provide only a short amount of time to prepare a document, hence, a tight timeline. in either instance, the first step would be to identify the scope of the project and define expectations of the medical writer/editor and the client. for freelance medical writers/editors, other considerations may include if this is a new client or an established client and the time needed to educate on the process. taking on a rush project from a new client is riskier because the client may be new to the process in general or may not have worked on a given document type. dr singleton emphasized, “as a freelance medical writer, the best asset i have to offer is my word,” and taking on a project that could potentially compromise quality could impact a writer’s reputation. there is a lot of value added in taking the time to educate a new client on how the process might look, setting expectations, and establishing a schedule. if the timeline does not account for this, the client may not be a good fit. in academia, there is more flexibility in timelines for many documents, with the exception of grant proposals. however, it is still important to set expectations and educate stakeholders on the process and typical turnaround times. advice for new writers and editors the first piece of advice given by ms byram, dr singleton, and dr chiavolini to new writers when working on a document with a tight timeline was to ask questions. asking questions may slow down the process, but it is imperative to get as much information as needed upfront from the client and to fully understand the agreements being made and to clarify deliverables. another critical piece of advice is to set boundaries. freelance writers are typically hired to solve problems that a client may not have the experience or expertise to solve. establishing boundaries (eg, typical turnaround times and exceptions) and expectations from both the writer and the client early in the process is important. boundaries are not meant to create barriers and hinder progress, instead they strengthen collaboration between the writer and client, keeping the project focused and on target. strategies used when a project is not on schedule when working on a tight timeline, every minute matters. if a risk arises that could potentially cause a project timeline to not be met, the best strategy is communication. reaching out to the project team as soon as possible is critical. it also provides the opportunity to ask questions. is the scope of the work negotiable? is it possible to focus on the key messages of the document rather than the language? if the project team is not providing the information needed to author pertinent sections of the document, reach out to the principal investigator for assistance; for example, ask whether there is a possibility for timeline extension. proactively setting expectations and maintaining clear communication throughout a project can help to keep the project on schedule. tools a variety of tools are available to assist with authoring, editing, and composing documents of all types, and ensuring timelines are met. examples of tools utilized by ms byram, dr singleton, and dr chiavolini for different documents are provided below. • consort (consolidated standards of reporting trials) guidelines and extensions for writing manuscripts • plain language guidelines (eg, multi-regional clinical trials center’s clinical research glossary, released in june 2021) • client-specific style guide cheat sheets http://www.amwajournal.org amwajournal.org 27session reports • second (or even third) computer monitor • printouts of grant request for proposals and request for applications • templates for writers • glossaries from cancer centers or other stakeholders • digitally curating information • time tracking/management tools • optimizing software already in use • checklists and detailed project notetaking a medical writer’s ability to take on new projects depends on the scope and timeline for a given document. clear communication, educating the client, and setting expectations and boundaries upfront are needed to ensure the project is completed according to the timeline, without compromising quality. in their presentation, ms byram, dr singleton, and dr chiavolini provided several strategies for assessing the ability to take on a project with a tight timeline, as well as several tools for creating high-quality documents within that timeline. stephany panlilio is a senior associate in medical writing at gilead sciences, inc. (foster city, ca) author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. author contact: stephany.panlilio@gilead.com * * * time to clock in: applying manufacturing best practices to consistently and efficiently produce high-quality documents speaker jenni pickett, phd, whitsell innovations, inc., chapel hill, nc mary ellis bogden, ba, whitsell innovations, inc., chapel hill, nc by stephany panlilio, ms regulatory writing and manufacturing have many commonalities. as with manufactured products, regulatory documents should be produced at a reasonable cost, completed per an agreed upon timeline, be fit for intended purpose, and should meet a set of corporate, legal, and customer standards. what can regulatory writers learn from advances in manufacturing processes? manufacturing best practice philosophies many modern manufacturing processes and principles came from the car manufacturer, toyota. the toyota way operates under 4 driving principles.1 these principles can also be applied to medical writing, as described below. • long-term philosophy – forward thinking. focusing on the processes used to create products or documents can help improve efficiency over time. • add value to the organization by developing your people and partners. in manufacturing and regulatory writing, ensuring that team members have the right skills is essential. • the right process will produce the right results. a robust process will ensure a high-quality product. • continuously solving root problems drives organizational learning. manufacturers and regulatory writers should develop and maintain a system to identify root causes and quickly address issues. good regulatory writing practice manufacturers of pharmaceutical products must adhere to good manufacturing practice (gmp) to mitigate risk. a robust gmp quality system includes training people; controlling starting materials and equipment; clearly defining manufacturing, packaging, and storage processes; testing for quality; and documenting each step. to produce high-quality documents, the following are necessary: trained people, correct source materials that are up-to-date and easy to use, defined processes for the writing and review cycles, a quality control review process, and documenting each step (figure). so, what would a theoretical good regulatory writing practice include? • developing the team by ensuring team members have the proper education, relevant experience, and knowledge of regulations and company policies can help to reduce the risk of human error. specific risks to your team can be evaluated by a gap analysis of critical skills. cultivating a growth mindset culture in which employees feel comfortable being noisy in their ignorance helps identify critical training needs. • creating a quality document profile, similar to the quality target product profile used in gmp, verifies the correct template, sources, interpretation, and team expectations are used for the document. using a storage management system prevents errors due to use of incorrect templates, outdated data, or irrelevant sources. http://www.amwajournal.org a m w a news elise eller, phd / 2020-2021 director-at-large and chair and board liaison, member awards committee amwa fellowships amwa fellowships are awarded to members who have made significant contributions to the goals and activities of amwa. the 2021 fellows are leaders with distinguished records of service at the chapter and national levels. jennifer bridgers, ms, mwc jennifer bridgers brings a broad foundation of industry experience to her work, both in project and managerial roles. she has been writing for medical and technical audiences for over 20 years, including 17 years as a regulatory medical writer across many document types and therapeutic areas. as one of the first cohort of certified medical writers (mwc), jennifer has been actively involved with amwa throughout her career, including through attending 15 of the last 17 annual conferences. she served as president-elect, president, and immediate past president of the carolinas chapter from 2009 to 2012 and as a carolinas chapter delegate to the amwa board of directors. she has taught over 10 workshops, including “summarizing clinical safety data for an nda,” “writing an ich-compliant protocol” and “composing narratives for safety and adverse event reporting.” she has also led multiple roundtables and open sessions at both national and regional amwa conferences. jennifer’s contributions to amwa also include continued committee work, having served on the educational committee, the constitution and bylaws committee, and the regulatory education advisory group. she is the regulatory section editor for the amwa journal (2017 to present) and the chapter advisory committee representative for the carolinas chapter. r. michelle sauer gehring, phd, els r. michelle sauer gehring is a senior research scientist at the university of texas health center for advanced heart failure, an instructor at the university of california san diego, and the owner of rna editing, llc. she wrote her first grant in 2005 as a graduate student and has not stopped. after completing her phd in microbiology/genetics and a postdoctoral fellowship at baylor college of medicine, she began realizing that her talent was “in the writing” and transitioned from the academic faculty career path to medical communication. she joined amwa in 2009 and attained her certification as an editor in the life science in 2011. at the chapter level, michelle has served as treasurer, program chair, and president of the southwest chapter. she has also chaired conference planning committees at the chapter and national level. michelle was nominated to amwa’s national board of directors in 2018 and currently serves as the secretary and board liaison to the amwa journal. michelle is an active member of the medical communication community, has contributed multiple articles to the journal, and leads open sessions and roundtables at amwa conferences. she mentors and advises those new to the field and continues to work in the academic research sector as an instructor and as a grant and publication writer and editor. theresa e. singleton, phd theresa e. singleton is a freelance scientific writer and has worked in the field of medical communication for a decade. she holds a bs in nutritional science from cornell university and a phd in microbiology and immunology from boston university. following her graduate studies, she completed a postdoctoral fellowship at boston children’s hospital. theresa is owner and principal scientific writer at singleton science, llc, where amwa journal / v36 n3 / 2021 / amwa.org 131 a m w a news she specializes in publication writing and plain-language writing and editing. theresa has been an active amwa member since 2010, serving in leadership roles at both the chapter and national levels. she was the new england chapter’s secretary, president-elect, president, and immediate past president. at the national level, theresa served for 3 years on the board of directors. during that time, she chaired the member recognition committee and was board liaison for the amwa journal. theresa credits her business success, in part, to connections made with other amwa members. to pay it forward and help create a supportive environment for those new to freelancing, she has co-led jam sessions for early career freelancers at 3 amwa annual conferences. she continues to serve in volunteer roles as a member of the nominating committee and as chair of the amwa journal editor-in-chief search task force. when she’s not in the office or volunteering, she enjoys rhythm tap dance. please join amwa in congratulating jennifer, michelle, and theresa. they will be acknowledged at the 2021 medical writing & communication conference, to be held virtually october 27-29. the member awards committee members were elizabeth brown, elise eller (chair), andrea gwosdow, karen klein, mary knatterud, susan krug (ex officio), marianne mallia, and kristina wasson-blader. diane noland from amwa headquarters provided excellent support. www.amwa.org/knowledge_builders knowledge builders build your knowledge on a specific medical communication topic through a variety of elements designed to create an engaging educational experience. listen to a narrated slide set engage in exercises access the handout review the reading list note what you learned explore amwa online learning and get ready to l.e.a.r.n. 132 amwa journal / v36 n3 / 2021 / amwa.org http://www.amwa.org/knowledge_builders amwa journal / v36 n4 / 2021 / amwa.org 177 predatory publishing at the time beall stopped his blog scholarly open access in 2017, he had been tracking scholarly publishing, the exponential growth of predatory publishers, and predatory stand-alone journals for nearly 10 years. he became immersed in researching this online aspect of deceptive and questionable scholarly communication while a faculty librarian at the university of colorado denver, where he worked as an expert in metadata for library discovery systems. aiming to maintain the integrity of the academic record, beall created a list of suspect scholarly publishers and shared it with the public on his blog. beall’s list was free; it exposed various types of deceptive practices, corruption of the editorial office and peer review, fraud, and hidden publishing fees. with evidence received from duped researchers themselves and gathered from the predators’ websites, beall uncovered how these publishers lured researchers into such trappings, which was exacerbated by institutional pressures such as the publish-or-perish mindset. the path of academic publication became a razor’s edge: would authors take the narrow and often hurdled path of legitimate scholarly publishing or be lured knowingly or otherwise by predatory journals? beall’s commentaries examined flaws in open access, shortcomings of librarianship, and the effects of widespread library cancellations of subscription journals. he warned of a scholarly publishing industry that failed to regulate itself. as predatory publishers grew exponentially, so did the numbers of complicit authors who took the fast, easy route to publish and pay article processing charges (apcs) to advance their own careers. beall’s critics were not only the predatory publishers and the authors who published with them but those who dismissed the value of his work because he was a critic of open access. during the 5-year period that beall ran scholarly open access, predatory publishers grew from about 20 in 2011 to >1,100 in 2017. the research community was jolted when he closed his list, which is still used today in an archived version (https://beallslist.net). as of september 2021, cabells’ simon linacre reported in the firm’s blog the source the unfortunate accretion of 15,000 predatory journals (a third of which are medical titles) and a gray zone of nearly 30,000 journals (https://blog.cabells.com/2021/09/01/mountainto-climb). i had the privilege to speak with jeffrey beall during a zoom meeting in august of this year and later met up with him in denver in september. jeffrey beall is acclaimed for his work in alerting the global research community to the deep threats posed by predatory publishers in exploiting the gold open access publishing model. his work advocated for the protection of individual authors and the scholarly global community by maintaining the integrity of the academic record. he coined the terms predatory publisher, hijacked journals, predatory conferences, and misleading metrics and founded his blog, scholarly open access, in which he maintained a list of predatory publishers from 2012 to 2017. amwa readers can read his reflection on this period1 and track his investigative work exposing predatory publishers in his nearly 40 publications on the topic since 2008, including interviews, the archived version of scholarlyoa.com (https://beallsist.net), and youtube lectures. mary kemper, bs / medical writer, mayfield clinic, cincinnati, oh practical matters the razor’s edge of predatory publishing an interview with jeffrey beall https://beallsist.net https://beallslist.net https://blog.cabells.com/2021/09/01/mountain-to-climb https://blog.cabells.com/2021/09/01/mountain-to-climb 178 amwa journal / v36 n4 / 2021 / amwa.org interview amwa: we appreciate your taking the time to speak with amwa and want to acknowledge your work against predatory publishing. while you sought to safeguard research integrity, you established a foundation for thinking critically about this topic. many of us wonder how you have been since you stopped the blog. tell us about how you are doing now. beall: i retired in 2018 from my university of colorado faculty position. i moved to southern colorado, specifically walsenburg, colorado, in huerfano county and the nearby sangre de cristo mountains. as for tracking predatory publishing, i keep up by reading google alerts that i receive on the topic. recently, paolo crosetto’s blog piece “is mdpi a predatory publisher?” piqued my interest, as i had spent years tracking some of this publisher's troubling tactics on my blog.2 i occasionally accept invitations to speak, as i did earlier this year virtually for a university in spain. my invited opinion piece, “open access, research communities, and a defense against predatory journals” was published this year in a platinum open access journal for a medical society based in kazakhstan.3 i’m also digesting several articles analyzing my work. it’s both interesting and hard to read a critical analysis of one’s work. amwa: readers may be interested your background. most of your work on predatory publishing was done while you were a university librarian. what early experiences shaped your viewpoint and drew you to library science? beall: i’m from california, earned a bachelor’s degree in spanish, and thereafter served in the peace corps in guatemala. after completing a master’s degree in english, i went to saudi arabia and taught english to employees of the saudi government. within a year, i wanted a change, so i got my master’s degree in library science at the university of north carolina at chapel hill. after working in the library at harvard university for 10 years, i moved back to the west in 2000 to the auraria library at the university of colorado denver. throughout most of my library career, i quietly worked in the library's back room researching issues related to library metadata, full-text searching, and information retrieval. the roles of academic librarians were taking on increasing importance with the advent of scholarly open access publishing. my interest in scholarly publishing began in 2005 as a scholarly initiatives librarian. in 2008, i began tracking spam email invites to publish in what i would later call predatory journals. amwa: in your 2012 interview in the open access interviews column by independent uk journalist richard poynder, you describe your metadata work in librarianship and research in scholarly communication (https://poynder.blogspot. com/2012/07/oa-interviews-jeffrey-beall-university.html). how were your role and interests changing at that time? beall: as a faculty librarian, i studied bibliographic databases, including library catalogs, the effects of typographical errors in library databases, and the weaknesses of full text searching. in 2012, i gained tenure and was promoted to associate professor. academic libraries play an important role in vetting publishers and maintaining online repositories of benefit to authors, but they largely failed to warn about the shortcomings of open access. actually, the open access movement inspired many libraries to create new open access repositories; i've criticized them because they are expensive to operate (licensing fees, staff salaries) but are accessed very little. (print repositories of journals have indeed been weeded from libraries, but the online counterpart versions offer great added value and have been backed up well.) amwa: you came up with the term predatory publisher and became an activist for your faculty and the scholarly global community. what was that early period like? beall: my first article on the topic, a 2009 review of bentham open, highlighted how this publisher was exploiting the gold open access model with its 200 journals, each with few articles, and charging authors high publication fees.3 it was published in the charleston advisor, a journal that typically publishes reviews of electronic databases that librarians license. my review alerted libraries to the transgressions of this particular publisher and to the larger problem of linking to publisher sites like these, which flood the scholarly literature with poor quality work. i understood this was a new concept that needed a name. i landed on the term predatory publisher. i knew it wasn’t perfect but liked the predatory metaphor and felt the alliteration would help make it be easy to remember. i later learned in my travels that the term doesn’t always translate well. although others have advocated for a different term, predatory publisher caught on. i also coined the terms hijacked journal, predatory conference, and misleading metrics. the bentham open article went largely ignored until late 2011 when the nursing research community, specifically the international academy of nursing editors, took notice. they have since conducted extensive research and felt vulnerable, realizing that their many specialty nursing fields would be targeted by the predators. discussion of beall’s list on this tightknit community’s listserve garnered significant attention, and interest spread to other research communities. practical matters https://poynder.blogspot.com/2012/07/oa-interviews-jeffrey-beall-university.html https://poynder.blogspot.com/2012/07/oa-interviews-jeffrey-beall-university.html amwa journal / v36 n4 / 2021 / amwa.org 179 amwa: your 2012 article in nature entitled “predatory publishers are corrupting open access” 5 was published the same year that you launched your blog scholarly open access. you exposed their lack of transparency and their dishonesty, the effects of a lack of integrity on scholarly literature, the mutable nature of their deceit, and the public’s access to bad science. beall: this invited opinion piece for nature, published in september 2012, increased attention on this topic and led to the term predatory publishing going viral. after that, researchers from all over the world began forwarding me spam emails they received from newly appearing predatory journals, offering helpful tips on establishing criteria to evaluate them, and revealing their own misfortunes in dealing with these predators. these examples provided evidence for my blog posts and complemented what i uncovered on the websites of predatory publishers and stand-alone journals. amwa:you issued serious warnings at a time when numbers ranged initially from about 20 to later hundreds of predatory publishers and stand-alone journals. tell us about launching your blog scholarly open access. beall: my first list in 2010 was followed by scholarly open access in 2012. i wrote 2 blog posts each week; i enjoy writing and had lots to write about in explaining why i listed a particular publisher. some of the predatory publishers and journals were so clearly fraudulent or silly, and it was fun for me to write with a sardonic approach. nonetheless, the harm was proliferating. i noticed the medical research community was hit hardest. predatory publishers targeted grant funds, knowing that scholarly authors could use them to cover their apcs. they took advantage of the pressure-to-publish culture of medical research and appealed to busy clinical researchers, offering a fast, easy route to publish. amwa: you were bringing a lot of attention to your university. what was the response? beall: the university was of 2 minds. it favored the positive attention metrics that were garnered through the numerous mentions i and the university received on various websites and publications. however, the dark side of that attention emerged by 2013. predatory publishers on beall’s list began to lose income. they complained, asked to be removed, and began searching the university of colorado’s website to harvest the emails of various administrators. in their mass emails, their claims, such as that i was a criminal, were initially difficult to deal with. however, the university counsel quickly understood the motivation of their baseless accusations. my reviews on scholarly open access were comparable to a book review. that is, i applied the same skills used in organizing reviews of books or electronic databases for various professional library journals. i was clear that the blog's list and reviews were my opinion. amwa: beall’s list included predatory publishers and standalone journals that violated a number of traditional ethical norms in scholarly publishing practices. your work critiqued a particular publisher, constructing a foundation about how they exploited the gold open access model. how did you come up with this strategy, and how did it evolve as the number of predators was increasing? beall: researchers sent evidence, often in a trail of emails, after having unknowingly submitted their papers to predatory publishers. many became suspicious when, the day after submission, their article was accepted for publication and accompanied by an invoice for the apc. obviously there had been no peer review. researchers told me all kinds of stories of egregious practices by these predators and sent me the solid evidence related to transgressions of peer review integrity, editorial standards, business ethics, indexing, and archiving. amwa: you wrote twice-weekly blog posts about select publishers, such as frontiers or omics. you tracked their fake addresses to actual locations, found stolen identities, and detailed deceptive practices (eg, misleading metrics, claims of being included in prestigious scholarly indexes) to lure authors. can you describe your process of investigation and writing these commentaries? beall: for each blog post, i had evidence provided by researchers or evidence that i encountered myself. i also examined the publishers' websites for the number and quality of published articles and identified their predatory practices that violated scholarly norms. from the start, rather than individual journals, i focused on publishers, many of which had a fleet of journals. because these publishers would quickly add titles to their portfolio to generate income or remove others, tracking individual journals would have been impractical and time consuming. shortly after the launch of scholarly open access, various mentors gave feedback urging me to document the criteria used to assess the publishers. as the criteria evolved over time, i eventually used 3 versions during the 5-year period of scholarlyoa.com. amwa: what was noteworthy among the predatory journals that targeted medicine? beall: i first noticed the spam emails from library science journals when i was looking for places to publish. medical specialties, like nursing and ophthalmology, began to monitor activity in their fields. predatory publishers proliferated in medicine, practical matters 180 amwa journal / v36 n4 / 2021 / amwa.org often launching one journal per specialty based on a list of every specialty taken from a hospital’s department listings. big fleets of predatory journals were exploiting researchers, but there were also researchers taking advantage of their fast, easy, and often cheap publishing route. medical society journals contribute significantly to keeping societies afloat through a fair subscription price. these fees make a little overage that can help cover journal costs and pay for other services to benefit residents and students, for example. open access doesn’t work like that: apcs do not generate enough income for administrative services, such as managing peer review or providing high quality editorial support. amwa: besides providing highly detailed information, you framed the rise of predatory publishers in the context of the open access social movement and the culture of scholarly publications. how did your viewpoint about the open access movement evolve? beall: i was always critical of the open access movement. although scholarly open access publishing offers the benefits of being free to read for everyone and of allowing reuse and repurpose under the creative commons license, it had major flaws. from my position as a scholarly communication librarian, i argued that advocates for open access lacked foresight about its unintended consequences, such as open access threat to science or the pollution of research databases. their promotion continued even after the problems of predatory publishing clearly emerged. the open access movement attempted to stigmatize and shut down traditional scholarly publishers using the subscription model to publish high-quality vetted research. these publications appearing on library platforms also added value to research by increasing accessibility to resources and citations. amwa: in 2013, criticisms included your review criteria, transparency of your methods for placing a publisher on your lists, and other alleged biases found in your blog scholarly open access. omics threatened to sue. in 2015, some of your professional library colleagues cited bias. how did you weigh all these criticism and threats? beall: several publishers threatened but never actually sued. in 2019, a federal judge ordered the journal publisher and conference organizer omics international to pay $50.1 million to resolve the federal trade commission (ftc) allegations of deceptive claims and hidden apcs.6 although ordered to cease operations in the united states, the publisher responded by creating many smaller publishing brands, such as sunkrist, to hide the association with omics international. therefore, the action by the ftc, though significant, is not having any significant impact. for example, when a subsidiary of omics international acquired society journals, specifically pulsus in canada and its 2 dozen medical society journals, including cardiology, the journals’ quality declined. i discussed the strains of decreased library budgets, journal subscription cancellation projects, and the shortcomings of my own profession in ignoring the true causes of journal price increases to favor the more politically correct advocacy for open access.1 amwa: in 2014, you began a sabbatical at a time when there were more than 400 predatory publishers and more than 300 stand-alone predatory journals. what did you want to accomplish during that year? beall: during that 6-month period in 2014, i wrote several articles and traveled for speaking engagements, including to northern iraq. i enjoyed these engagements, which began in 2013, and eventually had traveled to dozens of states and 20 countries. amwa: you shut your blog down in 2017 with a listing of 1,155 publishers and 1,294 journals. you must have faced some difficult decisions during that period. beall: it was a very difficult period. within the first 6 months, i wrote “what i learned from predatory publishers,” my account about what i learned about scholarly publishing, the pressure that researchers face, and the aggressive strategies that some predatory publishers used to fight me.1 there was a lot of emotion in this article. one of the main and unique points that i made in this commentary was that researchers who publish in predatory journals often become their defenders. amwa: since 2017, researchers have tried to update your list or create their own unique lists of predatory publishers and/or journals for developing countries (http://kscien.org/predatory. php). in 2017, cabells scholarly analytics launched their subscription products that included their whitelist and blacklist of 4,000 predatory journals from 18 disciplines that violated their behavioral indicators.7 today cabells has subscription products called predatory reports and scholarly analytics and a team of experts to evaluate an estimated 15,000 predatory journals (a third are medical titles) and 11,000 legitimate open access journals, respectively. another 30,000 journals are considered to be in a gray zone. in his 2020 opinion piece “why we should have listened to jeffrey beall from the start,” mike downes says, “misguided criticism of beall himself was counterproductive in the fight against fraudulent publishers.”8 downes advocates for policy and prosecution of these scam open access predators. what’s the future of tracking predators and educating authors at a time when many may not have access to subscribe to those reports? practical matters http://kscien.org/predatory.php http://kscien.org/predatory.php amwa journal / v36 n4 / 2021 / amwa.org 181 beall: i’m glad cabells has taken on this effort. additionally, the business of scholarly publishing hasn’t adequately policed itself and needs to establish a credentialing system (eg, like the field of pharmacy) to separate bona fide journals and publishers acting in good faith from predatory journals and publishers. before open access, libraries played an important role in not subscribing to junk journals and in preserving scholarly integrity. amwa: through scholarly open access, you connected with academics and publishers from all over the world in exposing the high stakes on the razor’s edge of scholarly publishing. you identified numerous scams and harms caused by predatory publishers in ethics, finances, and quality, and pursued getting these open access scammers out of scholarly databases. you warned of the dangers of citation contamination, corruption of public trust in science, and risks to high-quality medical journals and research funding. thank you, jeffrey beall, for creating an outstanding resource for the academic community. your activism is a model for upholding the integrity of scholarly publishing, examining the flaws of open access, and avoiding the dangerous path of predatory publishing. acknowledgment my appreciation to barbara c. good, phd, and qing zhou, phd, for their valuable review. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: mkemper@mayfieldclinic.com and jeffrey.beall@ucdenver.edu references 1. beall j. what i learned from predatory publishers. biochem med (zagreb). 2017;27(2):273-278. https://doi.org/10.11613/bm.2017.029 2. crosetto p. is mdpi a predatory publisher? wordpress website. published april 12, 2021. accessed november 1, 2021. https://paolocrosetto. wordpress.com/2021/04/12/is-mdpi-a-predatory-publisher/ 3. beall j. open access, research communities, and a defense against predatory journals. cent asian j med hypothesis ethics. 2021;2(1):14-17. https://doi.org/10.47316/cajmhe.2021.2.1.02 4. beall j. bentham open. charleston advisor. 2009;11(1):29-32. 5. beall j. predatory publishers are corrupting open access. nature. 2012;489(7415):179. https://doi.org/10.1038/489179a 6. court rules in ftc’s favor against predatory academic publisher omics group; imposes $50.1 million judgment against defendants that made false claims and hid publishing fees. federal trade commission website. published april 3, 2019. accessed november 1, 2021. https://www. ftc.gov/news-events/press-releases/2019/04/court-rules-ftcs-favoragainst-predatory-academic-publisher-omics 7. kemper m. cabells scholarly analytics is a force of knowledge against predatory publishing—an interview with simon linacre. amwa j. 2021;36(1):30-32. 8. downes m. why we should have listened to jeffrey beall from the start. learn publ. 2020;33(4):442-448. practical matters a career in medical communication: steps to success learn about the skills and attributes needed to be a successful medical communicator and discover opportunities in the field. www.amwa.org/career_steps mailto:mkemper@mayfieldclinic.com mailto:jeffrey.beall@ucdenver.edu https://doi.org/10.11613/bm.2017.029 https://paolocrosetto.wordpress.com/2021/04/12/is-mdpi-a-predatory-publisher/ https://doi.org/10.47316/cajmhe.2021.2.1.02 https://doi.org/10.1038/489179a https://www.ftc.gov/news-events/press-releases/2019/04/court-rules-ftcs-favor-against-predatory-academic-publisher-omics http://www.amwa.org/career_steps v37 n3 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 41 the golden apple award is presented to a member of amwa to honor consistent, outstanding workshop leadership. this year’s golden apple recipient is brian bass, mwc. the member awards committee was impressed with brian’s long-term commitment to leading workshops for amwa and ability to keep his workshops engaging and his material timely and relevant. brian has a long history of supporting amwa’s educational mission. he founded the amwa-delaware valley chapter princeton conference in 1997, bringing a combination of educational workshops and sessions to amwa members throughout and beyond the delaware valley region. he continued to chair the princeton conference for 16 years. in 1997, brian also taught his first workshop, the creative process in pharmaceutical advertising & promotion. since then, brian has developed 3 new workshops to help participants develop, launch, and build successful freelance careers. over the years he has presented these 4 workshops a total of 21 times, with an overall evaluation score of 4.63 out of 5. brian has also developed and presented 36 open sessions and panel discussions, 16 roundtable presentations, and 10 webinars. please join amwa in congratulating brian. he will be acknowledged at the 2022 medical writing & communication conference to be held in denver, co from november 2–5, 2022. the member awards committee members were melissa l. bogen, elizabeth brown, sarah dobney (chair), mary knatterud, susan krug (ex officio), abbie roth, and michael schneir. diane noland from amwa hq provided excellent support. sarah dobney / 2021–2022 director-at-large and chair, member awards committee the golden apple award amwa news back row (l to r): susan krug, kim korwek, loretta bohn, brian bass, sarah dobney, gail flores. middle row (l to r): jennifer minarcik, laura sheppard, elise eller, ann winter-vann, shawn watson. front: katrina burton. not pictured (attended virtually): joan affleck, michelle sauer gehring, lynne munno, joanna pendergrass, julie phelan. the amwa board of directors met july 21-22, 2022 at the amwa headquarters office in rockville, md. the hybrid meeting allowed all bod to attend, either in person or online. http://www.amwajournal.org v37 n2 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 14 a systematic approach to manuscript editing speakers loretta bohn, els, senior editor/writer, rti international, research triangle park, nc kelly schrank, ma, els, freelance medical editor, bookworm editing services, llc, elberton, ga by christine holzmueller, ms loretta bohn and kelly schrank share their experiences “in the trenches” when managing manuscripts, including editing and submitting to peer-reviewed journals. as experienced manuscript editors, they believe the overarching goal is to “shine the best light” on the research and the authors. to expand beyond their own experiences, the speakers also surveyed editors to learn what they look for when editing a manuscript and reported their findings (figure). checklists can be used for a single manuscript and can also serve as a dashboard to manage multiple manuscripts simultaneously. bohn notes that checklist use shows your clients or employer that you are a professional and doing what you can to minimize errors on your part. schrank shared her checklist as an online supplement on the conference platform. also available to amwa journal subscribers, the checklist has sections for tracking/metrics, common manuscript features, abbreviations used, author instructions from the journal, notes, and final checks of the edited paper. a valuable tip when scanning the paper for the final check is to use “no markup” in track changes to make issues visible (eg, extra spaces, typos). noted advantages of using a checklist when editing: • consistency—of acronyms, abbreviations, phrases or terms, nomenclature for key concepts, and other information • structure—ensures requirements from the particular journal are met, sections are in correct order, and the right data/information is in the correct section • productivity—keeps you on task, avoids wasted time scrolling pages to check for consistency, reminds you of where you left off • tracking—deadlines, authors' return of information you requested, metrics to estimate time required for future editing projects author instructions are a gold mine of information bohn stresses the importance of abiding by the author instructions in manuscript preparation. instructions can cover everything from the article categories accepted and word count limits to formatting of references and figures. several tips: 1. add the url to the author instructions in the manuscript checklist (or in your bookmarks for that client). 2. thoroughly read the instructions. 3. if another person is formatting the manuscript, copy and paste pertinent instructions in an email to save them from sifting through information. session reports 2021 conference figure. what are editors looking for… aan 8-item survey was developed by kelly schrank and loretta bohn; it was posted on amwa engage and linkedin and emailed to the board of editors in the life sciences’ mailing list and rti international employees. manuscript editing checklists are a valuable tool a good checklist can help editors develop a plan, stay organized, and be more efficient when editing manuscripts and submitting them to journals. a highly recommended book that describes compelling reasons that checklists are valuable is the checklist manifesto by atul gawande, md, mph, a renowned surgeon.1 what are editors looking for… (n = 12a) …in each section? editing standards (eg, grammar, punctuation, syntax, readability, and spelling) are met. content addresses the intended purpose of that section. section contains the components specified in journal guidelines. …when evaluating the manuscript as a whole? terms and definitions are consistent. information flows coherently and logically. research methodology demonstrates good science. journal requirements are met (eg, word limit, reference format, title page components). http://www.amwajournal.org amwajournal.org 15session reports look for author instructions on the journal’s home page, which may be in a tab near the top or a link along the side or near the bottom of the page. note that submission instructions are usually different from author instructions. submission instructions include the platform for uploading your manuscript files, any publication fees, and other relevant information. common features of manuscripts schrank toured the common features of modern manuscripts, showing both organization and what information goes where. journals do vary in placement for some information; here are common things to check: • information required on title page • specific subheadings for abstracts • acknowledgements section—thank contributors (eg, statisticians, medical writers) • source(s) of funding • conflicts of interest—sometimes duplicated dummy submissions allow editors to discover what the journal requires if the target journal is known, start a dummy submission in the online portal using the login id and password of the submitting author. gathering all information and materials from your authors ahead of time will avoid delays when it is time to submit the manuscript. once you start the dummy submission, read the instruction prompts carefully for any surprises (eg, a cover letter is required and authors have not written one). common information requested on submission: • email addresses for all authors • biography of each author • suggested peer reviewers and email addresses; some journals require it and want up to 3 names • conflicts of interest/wording of statement for no conflicts • open access fees (do authors know this and want to pay for it?) • summary box/key messages of the research once the manuscript is submitted, it will follow 1 of 3 paths (table), and some authors will also engage the editor in this phase. christine holzmueller is a senior technical writer at the johns hopkins university armstrong institute for patient safety and quality, baltimore, md. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: cholzmu@gmail.com reference 1. gawande a. the checklist manifesto: how to get things right. metropolitan books; 2009. * * * where data, design, and technology meet: effective infographic strategies for health communication speaker kathleen walker, content strategist, communicate health, fort worth, tx by sunali wadehra, md what is an infographic, and why are they important? an infographic is a graphic visual representation of information, data, or knowledge that is intended to present complex information quickly and clearly. slick graphics and data visualization are used to engage the audience, and visual storytelling is used to convey a concept. a well-designed infographic helps people find what they need, understand what they find, and remember what they read. note that not just any chart or graph qualifies as an infographic; it must represent this criterion. table. three paths of a manuscript path role of the editor accepted read the article proofs carefully for issues introduced by the journal editors (eg, typos) and for behind-thescenes comments that should have been removed respond to queries/comments addressed to the authors deter authors from requesting new revisions, as this could be costly (if it is allowed) revise and resubmit ensure response letter is polite; thank the reviewers for suggestions (even if slightly off base) help author pick the important battles; yield to suggestions and points when ethically possible ensure that the revision is better, not worse, than the original text explain to the reviewer what was changed and why follow instructions for how the editor wants to see changes to the manuscript (eg, track changes visible, detailed cover letter) rejected submit to another journal rework manuscript then submit elsewhere http://www.amwajournal.org a m w a news katrina r. burton, bs / 2021–2022 amwa president the american medical writers association (amwa) board of directors (bod) is an integral part of the organization, and as stated by article iii in the amwa bylaws, manages and controls the affairs, property, and business of amwa. the bod meets consistently throughout the year as an organized body to discuss and take action on items as they pertain to the organization. the bod is responsible for approving the budget, committees, work groups, task forces, and the slate of nominees for elected office. the bod has the right to empower the executive committee consisting of the president, president-elect, immediate past president, secretary, and treasurer to act in between full bod meetings. in alignment with amwa bylaws, the bod shall include elected officers, an executive director, a chair of the chapter advisory council, and at least 5 appointed at-large directors. the number of members on the bod during the board year shall be no less than 12 and no more than 17. the full scope of the bod’s responsibilities can be found in article iii of the bylaws of the american medical writers association. it is with great pleasure that i announce the amwa 2021-2022 at-large directors, approved by the bod at the september 2021 meeting. • joan affleck, mba, els • brian bass, mwc introducing the 2021-2022 board of directors 188 amwa journal / v36 n4 / 2021 / amwa.org • loretta bohn, ba, els • sarah dobney, mph • kimberly korwek, phd • lynne munno, ma, ms • joanna pendergrass, dvm • laura sheppard, mba, ma • shawn watson, pharmd, phd, bcps • ann winter-vann, phd the bod also approved the chair of the chapter advisory council (a voting member of the bod): • jennifer minarcik, ms amwa 2021-2022 officers: • president: katrina r. burton, bs • president-elect: elise eller, phd • secretary: r. michelle sauer gehring, phd, els • treasurer: julie phelan, md, mba • immediate past president: gail v. flores, phd amwa executive director: susan krug, ms, cae serves as an ex officio member of the bod (nonvoting member). the 2021-2022 bod began its service on november 12, 2021, at the conclusion of the 2021 annual business meeting. amwa bod the above images were captured during the virtual board of directors meeting on november 5, 2021. 152 amwa journal / v36 n4 / 2021 / amwa.org abstract the american medical writers association formed a working group in 2020 focused on understanding and communicating the value that regulatory medical writers contribute to project teams, companies, and the wider research community. the working group developed a survey designed to gather information about the value that regulatory writers represent. the survey was targeted to regulatory medical writers, included 25 questions, and was administered by using surveymonkey. a total of 548 responses were received, and 522 of the respondents were active regulatory medical writers. the survey revealed that writers felt most valued when they were consulted or had their opinion sought (n = 154, 30.8%), contributed to patients and the community (n = 89, 17.8%), and were well compensated (n = 80, 16.0%). writers felt that their most valuable contributions to document preparation were clarity (n = 196, 44.1%) and organization (n = 80, 18%). although most writers indicated that their employers provided sufficient opportunities for training and advancement (strongly agree, n = 131, 29%; agree, n = 197, 44.1%), writers also indicated they would benefit from additional training in leadership skills, project management, and collaborative skills/diplomacy. this insight is invaluable for shaping the future of the regulatory writing profession. introduction at its core, medical writing involves gathering, organizing, interpreting, and presenting complex information in a clear, concise, and coherent manner to a variety of audiences. specific responsibilities can vary greatly across the industry, with roles and opportunities for medical writers constantly evolving. in this ever-changing environment, the role of regulatory medical writers is not always clear, and there is evidence to suggest that medical writers’ contributions are not always fully understood or recognized.1 to better appreciate the concrete value regulatory medical writers contribute to projects, teams, companies, and the wider biopharmaceutical industry, the american medical writers association (amwa) executives forum established a taskforce to define and quantify the value of medical writing. the 3 focus areas of the taskforce include writers’ perceptions of their own value, regulatory agency perceptions of a writer’s value, and other key topics related to the value of medical writers. this article describes the work of the subgroup tasked with determination of regulatory medical writers’ perceptions of their own value. the main goals of this subgroup were to discover the views of regulatory medical writers regarding the nature of the value they contribute, identify aspects of the role that make writers feel most valued, and inquire about team feedback and dynamics. we also sought to identify additional skills, training, and opportunities for development that would benefit writers while also increasing the satisfaction of their teams. methods a 25-question survey was designed to evaluate multiple domains regarding the perceived value and contributions of regulatory medical writers. the intended time taken for respondents to complete the survey was 10 minutes, and the average duration of participation was determined to be less than 10 minutes. many of the survey questions were multiple-choice questions, with some requesting a single answer and others allowing multiple answers (check all that apply). additional questions allowed participants to rank their preferences. other questions were presented in a 5-point likert-scale format. one question was an open field that allowed participants to provide general comments on the topic at hand. dylan harris,1 cathy tyrrell,2 amy myers,3 cynthia carr,4 and karen l. fink,5 on behalf of the amwa value of medical writing working group / 1takeda pharmaceutical company limited, lexington, ma, usa; 2seqirus, a csl limited company, summit, nj, usa; 3jazz pharmaceuticals plc, dublin, ireland; 4roche tissue diagnostics, tucson, az, usa; 5harpoon therapeutics, south san francisco, ca, usa value of medical writing: the regulatory writer’s perspective f e a t u r e amwa journal / v36 n4 / 2021 / amwa.org 153 the survey was targeted to regulatory medical writers; the first question in the survey was binary (yes/no) and confirmed this status. the survey was administered by using surveymonkey to members of the amwa medical writing community, the european medical writers association (emwa) medical writing community, and the dia medical writing community. working group members also distributed the survey to colleagues who were known to be regulatory medical writers and to partner companies who had regulatory medical writing groups who agreed to participate. the survey was completely anonymous. however, some analyses utilized the anonymized participant number to track responses to different questions from the same participants in attempting to identify trends in the data. participant profile to better understand the characteristics of survey participants, several survey questions focused on demographics and work history. in response to the question, “are you currently working (or have you worked within the past 5 years) as a regulatory medical writer?” we received a total of 548 responses, and 522 respondents (95.3%) confirmed current employment as regulatory medical writers. the second question in the survey inquired about work status. a total of 548 responses were also received for this question, and 488 (89.1%) were “employed,” whereas 53 (9.7%) were “freelance or self-employed,” 4 (0.7%) were “retired or unemployed,” and 3 (0.5%) chose “other” as a category of employment. when asked about the type of company the respondents were employed by, a total of 518 responses were received, and the top 3 responses were (1) pharmaceutical company, (2) clinical or contract research organization, and (3) biotechnology company (table 1). when writers were asked about the larger group in which the regulatory writing group resided, the top response indicated that medical writing stood alone as a group (table 2). however, as this is contrary to the experience of the members of the amwa working group, it may be suggestive of some ambiguity inherent in the question, although it may be a predictable response in smaller companies or in clinical research organizations (table 1; 22.8% of respondents). some of the responses in the “other” category included “clinical affairs,” “data science and safety reporting,” “document solutions group,” and “regulatory documentation and submissions.” the tenure of the regulatory writers who responded to the survey reflected long-term experience and the longevity of their dedication to the profession. a total of 444 writers responded to our question about years of writing experience, 242 (54.5%) of whom had more than 10 years of experience in the regulatory writing profession. a total of 84 (18.9%) respondents had between 6 and 10 years of writing experience, whereas 91 (20.5%) had between 2 and 5 years of experience and 27 (6.1%) had less than 2 years of experience. more than half of respondents had either a phd degree (n = 206, 46.4%) or another advanced degree (n = 27, 6.1%); 147 (33.1%) respondents had a master’s degree, 56 (12.5%) had a bachelor’s degree and 8 (1.8%) respondents specified a degree of “other.” a total of 440 writers responded to a query regarding gender, with 330 (75%) writers identifying as women, 83 (18.9%) identifying as men, and 27 (6.1%) choosing “prefer not to say.” overall, professionals responding to this survey were highly educated, a high proportion were women, and most had long-term experience as regulatory writers. this is indicative of a profession that generally requires a high level of education and offers table 2. organizational structure housing regulatory writing group parent group/organization responses (n) responses (%) medical writing stand-alone group/function 198 38.2 regulatory affairs 115 22.2 clinical development 68 13.1 clinical operations 52 10.0 other (please specify) 32 6.2 biostatistics or biometrics 18 3.5 not applicable 16 3.1 medical affairs 11 2.1 strategic operations 4 0.8 pharmacovigilance 2 0.4 quality 2 0.4 table 1. analysis of employment for regulatory medical writers type of employer responses (n) responses (%) pharmaceutical company 261 50.4 clinical or contract research organization 118 22.8 biotechnology company 56 10.8 medical device company 29 5.6 medical communication company 23 4.4 full service provider/staffing company 15 2.9 other (please specify) 13 2.5 medical school or university 2 0.4 medical marketing, advertising, or public relations agency 1 0.2 154 amwa journal / v36 n4 / 2021 / amwa.org long-term employment and development. the paucity of respondents with less than 2 years of experience (6.1%) may reflect slow recruitment of writers or a slow growth rate for the pool of regulatory writing professionals. alternatively, it could represent our inability to reach more junior medical writers. however, if this rate is representative of the industry at large, it is concerning, given the high growth rate for medical writing needs in the biopharmaceutical industry. roles and career progression we inquired about specific roles of medical writers to better understand how they are contributing, to learn what employers expect from medical writers, and to explore the relationship between required level of skill and the various roles of the writer. these survey questions categorized medical writing roles to reflect increasing levels of both technical skill and responsibility in order to understand the distribution of skills within the respondent pool (table 3). the majority of respondents report involvement in activities beyond basic document preparation following a template. most provide strategic guidance to teams and participate in some form of project management activity. consistent with the long duration of tenure in the respondent pool, a relatively large proportion of respondents identified themselves with role c, representing a very high level of technical skill, knowledge, and responsibility. to better illustrate the relationship between experience and role, we analyzed the responses for each role by years of experience (figure 1). although there was not an exact linear correspondence in the relationship between increasing years of experience and increasingly challenging roles, there was certainly a trend for professionals with longer tenure to fill the more challenging roles. most individuals in the management/ project management category had at least 10 years of experience in regulatory writing. these data indicate that regulatory writing is a highly technical discipline, and development of the necessary expertise to assume more strategic and management responsibilities appears to require several years to develop. this also suggests that regulatory writing is a career that offers long-term progression and development. value assessed by writers and teams understanding and harnessing the skill set of experienced regulatory writers can keep writers engaged and make them feel satisfied and fulfilled. when writers were asked what made them feel most valued as a medical writer (and were forced to choose one answer), there was a clear leader among the options provided (table 4). medical writers felt most valued when their opinions were sought and when they were included in decision-making. this aspect of feeling valued was chosen by more respondents than any other aspect, including compensation and other forms of recognition. some responses in the “other” category were (1) “medical writers have unique skills that fill a need, unmet by any other discipline involved in healthcare”; (2) “coaching and training of new or junior writers”; and (3) “authorship and being consulted; having my ideas taken seriously and acted upon.” the same question was posed with a requirement to rank these items and there was an identical response pattern, except that “autonomy/flexibility” and “recognition” switched table 3. analysis of roles among regulatory writers role responses (n) responses (%) a. i provide medical writing support/service to teams that is mainly focused on document preparation, using knowledge of templates, and ich and other guidance(s). 138 27.6 b. i provide support described in item a, but also provide strategic guidance to the teams. 126 25.2 c. i provide support in items a and b and manage submissions documents and lead teams through ctd preparation routinely. 171 34.2 d. management and/or project management. 43 8.6 other (please specify). 22 4.4 ctd, common technical document; ich, international council for harmonisation of technical requirements for pharmaceuticals for human use. figure 1. relationship between experience and roles. ctd, common technical document. 100% 80% 60% 40% 20% 0% a management project management submission/ctd preparation/ management plus b (c) strategic guidance plus a (b) document preparation (a) ➔ ➔ ➔ b c d < 2 years 2 to 5 years 6 to 10 years > 10 years (n=138) (n=126) (n=171) (n=43) amwa journal / v36 n4 / 2021 / amwa.org 155 positions in the rate of response/rank. interestingly, “career progression/job title/opportunity for movement” remained at the bottom of the list, with only 4.7% of respondents choosing this as their top ranked item. many writers felt that their tactical and technical skills were fully utilized, as well as their scientific and strategic skills (figure 2; n = 495). additionally, most writers felt that the teams they supported fully recognized their value and skills. a total of 265 (53.5%) respondents agreed with this statement, whereas 107 (21.6%) strongly agreed. interestingly, only 48 (9.7%) respondents disagreed, and 6 (1.2%) strongly disagreed. consistent with these positive responses, most writers also felt that they were empowered by management to provide clear guidance to their team regarding the document development processes and felt they were included in most necessary meetings that enabled them to remain aware of strategic decisions that could impact document development (figure 3; n = 495). table 4. what makes regulatory writers feel valued what makes me feel valued? responses (n) responses (%) consulted/opinion sought/ decision-making 154 30.8 making a contribution to patients/community 89 17.8 compensation 80 16.0 involvement in scientific research/developing your own scientific knowledge 77 15.4 autonomy/flexibility 32 6.4 recognition 31 6.2 career progression/job title/ opportunity for movement 28 5.6 other (please specify) 9 1.8 figure 2. utilization of skill sets. 0% 20% 60%40% strongly agree agree strongly disagree disagree neither agree or disagree technical and tactical skills 0% 20% 60%40% strongly agree agree strongly disagree disagree neither agree or disagree scientific and strategic skills figure 3. key determinants of success. 0% 20% 60%40% strongly agree agree strongly disagree disagree neither agree or disagree empowered by management 0% 20% 60%40% strongly agree agree strongly disagree disagree neither agree or disagree included in key meetings 156 amwa journal / v36 n4 / 2021 / amwa.org although regulatory writers provide value to teams in many ways, we sought to understand the perception of writers themselves in terms of the value they contribute. when writers were asked to select one area in which they provide the most value in document preparation, there was a clear top choice (table 5). writers indicated that they contributed the most value by providing clarity in documents (44.1%), followed by “organization” (18.0%), “completeness” (10.1%), “accuracy” (9.9%), and “adherence to standards” (9.9%). when writers were asked this same question but allowed to check all areas in which they contributed value, clarity was still at the top of the list (95.3% of writers included this in their selections), and organization was still in second place (90.8% of writers included this in their selections). a general comment regarding the value of medical writers was provided by 102 (18.6%) writers. key themes in the responses were the value provided to teams to ensure that the documents will lead to a successful submission. an example is this response: “the quality and delivery time of regulatory documents improved dramatically when my employer established a medical writing department within clinical operations.” the responses indicate that clear, well-written, and accurate messages are an important part of the medical writer’s role and that this is best achieved by integration into project teams. a response that expressed this was, “clinical–regulatory writers are critical members of the team who guide development of documents with an overall perspective for program strategy and a document that is complete, accurate, and well-written.” the responses indicate that this enables the medical writer to lead team collaboration, ensure that documents support project goals, and drive the process to speed delivery and ensure high quality/regulatory compliance. a representative response was, “we take ownership and drive/lead the document through the process, and only by guiding the team do we get through it.” several writers stated that the role of the medical writer is underappreciated. insight is provided by this response: “much of the value can go unnoticed by management as it is difficult to measure what good clinical–regulatory writers provide to documents and the document completion process.” pivoting to inquiry regarding the value that teams perceive as writers’ greatest contributions, the skills that writers felt they were most frequently recognized for were leadership and collaboration skills (table 6), both considered to be behavioral skills or “soft skills” rather than technical skills directly related to writing.2 when asked to rank the frequency of recognition of skills, the 3 top responses remained consistent, with all the other skills/behaviors ranking at least 5% beneath the third most highly ranked skill (table 6; 17.5%, providing strategic guidance on document development and/or submissions). interestingly, when this line of inquiry was reversed and we asked writers to provide information about constructive feedback they received from teams about areas for improvement, responses in the “other” category represented the highest proportion of responses (table 7; n = 110, 24.4%). however, the most common entries in the “other” category open field were “none” and “not applicable,” and there was no consistent trend, suggesting that inclusion of that option/field may have detracted from the precision of the data. the next 2 most table 5. areas in which writers provide value in document preparation area of document preparation responses (n) responses (%) clarity 196 44.1 organization 80 18.0 completeness 45 10.1 accuracy 44 9.9 adherence to standards 44 9.9 explanation of rationale 22 5.0 brevity 9 2.0 formatting 4 0.9 linking 0 0.0 table 6. skills and contributions recognized most frequently by teams skill recognized by teama responses (n) responses (%) leadership, including management of the process and maintenance of timelines 148 32.8 collaboration and flexibility 116 25.7 providing strategic guidance on document development and/or submissions 79 17.5 writing skills with respect to vocabulary and sentence structure, grammar, improved readability, etc. 34 7.5 comment resolution and achievement of consensus 26 5.8 problem-solving 19 4.2 quality control and accuracy 19 4.2 compliance 5 1.1 input to study design and project decisions 5 1.1 asurvey respondents had to choose only one skill. amwa journal / v36 n4 / 2021 / amwa.org 157 frequent responses were (1) leadership, including management of the process and maintenance of timelines, and (2) improve flexibility. therefore, the 2 items writers felt they were most frequently recognized for doing well were also the 2 specific items for which they felt that teams requested improvement or better support. these data suggest that leadership and collaboration should be key areas of focus for writer development. when writers were asked to rank (from 1 to 7) the 7 skills for which teams had requested better support (“other” was not included), leadership and lack of flexibility were still cited as the top areas for improvement (table 7). training opportunities and needs one of the main reasons for conducting this research was to identify potential gaps between medical writer skills and team and/or employer expectations. although this investigation relies on information gathered from regulatory writers and not teams or employers, we can compare our results with research conducted by another group2 as it relates to the pharmaceutical medical writing competency model.3 according to information heisel-stoehr and schindler obtained from 73 job advertisements for regulatory medical writers, “science” and the “comprehension of scientific concepts” were important technical skills cited in 78% and 92% of those job advertisements, respectively.2 our survey suggests that writers are not primarily recognized for such contributions during document development. additionally, writers themselves felt that their most important contributions to document development were clarity and organization, technical writing skills that may or may not require a deep scientific understanding. on the other hand, the 73 job advertisements described by heisel-stoehr and schindler cited “leadership and team working skills” as the most frequently (62%) mentioned behavioral skill/skills for regulatory writers.2 in fact, our survey results find that these are the 2 areas for which writers are most frequently recognized by teams for commendable performance (table 6). although most writers in our survey felt that their employers provided them with sufficient opportunities for training and development to enable success and advancement (agree, n = 197, 44.1%; strongly agree, n = 131, 29.3%), there were others in the survey who felt neutral (neither agree or disagree, n = 78, 17.4%) and some who disagreed (n = 30, 6.7%) or strongly disagreed (n = 11, 2.5%). these results speak well of management efforts to keep writers engaged and developing. when writers were asked to identify areas in which they needed more opportunities to learn, there was a significant focus on (1) leadership skills, (2) project management, and (3) collaborative skills/diplomacy (figure 4). once again, the notion that behavioral skills or “soft skills” play a prominent and crucial role in the successful execution of the duties of the regulatory writer is reinforced throughout the results of our survey. summary results from the survey encompassing 548 respondents with regulatory medical writing experience revealed key information that is useful for understanding the value that medical writers bring to an organization and useful for further defining job responsibilities and skills needed for regulatory medical writers. regulatory medical writers are highly educated professionals whose development to attain the skills necessary for leading regulatory submission preparation and managing projects and teams requires several years. the role requires both technical/tactical skills and scientific/strategic skills. most regulatory medical writers report that their duties extend beyond basic table 7. constructive feedback from teams skill that needs improvement responses (n) responses (%) other (please specify) 110 24.4 leadership, including management of the process and maintenance of timelines 79 17.5 lack of flexibility 62 13.7 compliance with procedures 61 13.5 comment resolution and achievement of consensus 45 10.0 writing skills with respect to vocabulary and sentence structure, grammar, improved readability, etc. 36 8.0 quality control, too many errors 36 8.0 collaboration 22 4.9 figure 4. areas desired for more training/learning. 0% 20% 60%40% project management 80% leadership skills collaboration skills/diplomacy effective communication technical / writing skills quality control other (please specify) 158 amwa journal / v36 n4 / 2021 / amwa.org document preparation following a template to include providing strategic guidance to teams and participating in some form of project management activity. project teams rely on medical writers for leadership and collaborative skills. medical writers recognize these soft skills as both their key contributions and their key training needs. data suggest that regulatory medical writers feel most valued when their opinions are sought and when they are included in decision-making. acknowledgement thanks to susan krug, amwa executive director, who provided significant support setting up the survey and with communication to survey participants. we also wish to thank the membership of amwa, emwa, and the dia medical writing communities for their participation in the survey. author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. the opinions expressed in this article are the authors’ own and not necessarily shared by their employers or amwa. author contact: dylan.harris@takeda.com references 1. marchington jm, burd gp. author attitudes to professional medical writing support. curr med res opin. 2014;30(10):2103-2108. 2. heisel-stoehr s, schindler tm. pharmaceutical medical writing competencies: comparing self-perception with employers’ expectations. med writing. 2012;21(3):225-231. 3. clemow d; dia medical writing special interest area community competency model working group. pharmaceutical medical writing competency model. amwa j. 2011;26(2):62-70. get fit with amwa f ast i nteractive t raining amwa’s fit series helps medical communicators stay healthy. in only 15 minutes—jog your memory, tone your writing muscles, build your core skills, and stretch your knowledge. www.amwa.org/fit only $15 each / approved for .5 ce topics in the series include: } misplaced modifiers } mean, median, and mode } dangling participles } measures of variability amwa journal / v36 n1 / 2021 / amwa.org 45 in a previous installment of this series (vol. 26, no. 4), i urged writers and editors to consider whether each of the subject-verb and subject-verb-object relationships expressed in their sentences is literally true. in medical writing, we deal mainly with facts. thus, most of what we write should be literally true. however, it is sometimes acceptable and even necessary for medical writers to use figurative language, such as metaphors and metonyms, that don’t express literal truth. scientists use metaphor and analogy to make sense of the world and to express their ideas to others. for this reason, scientists often use metaphors in their writing. literal or figurative language the word literal comes from the latin word literalis, which means “of or belonging to letters and writing.” it came to mean “according to the exact meaning of the word” (eg, the word’s dictionary definition). in contrast, the word figurative refers to figures of speech. a figure of speech is any deviation from literal meanings or common usage. this could mean using some deviation from ordinary grammar or word order, or it could mean using a word to mean something other than its customary meaning. shakespeare often used figurative language to express intense emotion: but soft, what light through yonder window breaks? it is the east, and juliet is the sun. arise, fair sun, and kill the envious moon, who is already sick and pale with grief that thou, her maid, art far more fair than she. —william shakespeare, romeo and juliet, act 2, scene 2 to understand such a poetic passage, it is helpful to create a paraphrase, which is a restatement of the meaning of a text or passage in different words. here’s how romeo’s speech would sound if stripped of its figurative language: i see juliet through her window. she is more beautiful than her cousin rosaline, who should be jealous of her. this paraphrase captures the literal meaning of romeo’s speech but fails to express the intensity of his infatuation. romeo had previously been smitten with juliet’s cousin, rosaline: “the all-seeing sun / ne'er saw her match since first the world begun.” but now, he is saying that juliet is the sun. metaphor a metaphor is a figure of speech in which a word or phrase (eg, the sun) is applied to an object or action to which it is not literally applicable (eg, juliet). the word metaphor comes from the greek for to transfer. in a metaphor, some attributes are being transferred from a figure (also called a vehicle) to a ground (also called a tenor). in one of romeo’s metaphors, the sun is the figure and juliet is the ground. in another, he calls upon the sun to kill the moon. that command contains 3 figures (sun, kill, and moon) and 3 grounds (juliet, displace, rosaline). many scientific terms started as metaphors. for example, robert hooke used the word cell, which literally meant a small room, to refer to the microscopic structural units he saw in plant tissue. the so-called cells in plant and animal tissue are not literally rooms, just as juliet is not literally the sun. nevertheless, the word cell came to be the official name for the smallest structural and functional units of all living things. extended metaphor once romeo has established that juliet is, metaphorically speaking, the sun, he can use the moon as a metaphor for some lesser woman. thus, he is using an extended metaphor, which is a metaphor that sets up several subsidiary subjects or comparisons. mixed metaphor a mixed metaphor (sometimes playfully called a mixaphor) is one that leaps from one identification to a second identimetaphorically speaking laurie endicott thomas, ma, els / madison, nj 46 amwa journal / v36 n1 / 2021 / amwa.org fication that is inconsistent with the first. merriam-webster’s dictionary offers this one: if we want to get ahead, we’ll have to iron out the remaining bottlenecks. you use an iron to smooth out wrinkles, not to remove bottlenecks. mixed metaphors can be confusing. sometimes, they are used for comical effect. avoid them unless you are a professional comedian. dead metaphor the expression dead metaphor is itself metaphorical because a metaphor is never literally alive. a dead metaphor is a metaphor that has lost its metaphoric force through common usage. in other words, it is no longer a figure of speech. many technical terms, such as the word cell, started as metaphor only to become standard terminology. once the biologists’ definition of the word cell was added to the dictionary, the use of the word cell to refer to the smallest structural and functional unit of an organism stopped being a figure of speech. a metaphor is merely dead if the term’s new meaning has become widely accepted. a metaphor is really most sincerely dead if its original meaning has been forgotten. for example, a mainstay was originally the rope or wire that held the ship’s mainmast in position. today, few people know the terms for nautical rigging. however, they commonly use the word mainstay to mean something on which someone or something depends (eg, rice is the mainstay of the diet in much of asia). metonym metaphors are often confused with metonyms. a metaphor creates a new link between 2 concepts from separate conceptual domains (eg, juliet belongs to the domain of humanity and the sun belongs to the domain of astronomy). in contrast, a metonym relies on an existing conceptual link. for example, people in the united kingdom, canada, and other commonwealth realms often use the word crown to refer to the monarch (who occasionally wears a crown) or to the national government in general. simile a metaphor is an implied comparison, often made by using a linking verb to connect ground with figure (eg, juliet is the sun) or by simply referring to the figure in a way that suggests the ground, such as by using the phrase “the elephant in the room” to refer to an obvious problem. in contrast, a simile is an explicit comparison of 2 unlike things, typically by using words such as as, like, or than. however, not all comparisons are similes. similes take the grammatical form of a literal comparison but express something that is not a statement of fact: my love is like a red, red rose. —robert burns clichés some metaphors and other figures of speech are so overused that they become clichés. a cliché is an overused phrase or opinion that betrays a lack of original thought. examples include “crystal clear” and “cool as a cucumber.” some clichés are metaphors, and some are not. • she dangled a carrot in front of his nose. (metaphor) • the explanation was as clear as mud. (simile) figurative language in medical writing there are no unbreakable rules for using figurative language in medical writing. on the one hand, medical writers are mainly concerned with conveying facts and truth as opposed to expressing emotion artistically. thus, medical writers should be cautious about using figurative language, especially when their audience includes poor readers or non-native speakers of the writer’s language or if the text is going to be translated. on the other hand, a large proportion of the technical vocabulary used in medical writing consists of dead metaphors, such as the word cell, as well as metaphors that are not quite dead yet. there are several good reasons for using figurative language in medical writing. one is to help your readers understand some complicated system or relationship. to do that, you may draw an analogy to something that they already understand or that you can at least explain. for example, many of the terms used for talking about how cells communicate with each other came originally from radio (eg, signal, amplification, gain, feedback). these terms were originally metaphors but lost their metaphorical force through common usage among cell biologists. another reason for using figurative language is convenience. for example, evolutionary biologists often talk about the evolutionary strategies of bacteria, plants, and lower animals. this use of the term strategy is a dead metaphor. it is a metaphor because the “strategies” in question do not represent anything that an organism is consciously choosing to do. evolutionary strategy is a dead metaphor because the dictionary already tells us that the word strategy can mean an adaptation or set of adaptations that contribute to evolutionary success. among microbiologists, the word strategy is a shorthand for that concept. shorthand is itself a dead metaphor. shorthand originally meant a method of rapid writing that involved abbreviations and symbols. thus, a shorthand came to mean a short and simple way of expressing or referring to something. some amwa journal / v36 n1 / 2021 / amwa.org 47 members of a lay audience may not understand that an evolutionary strategy is not something that the organisms are planning to do. so, depending on your intended audience, you may have to avoid using a shorthand or at least explain what the shorthand means. metonyms can also be used in medical writing, albeit cautiously. for example, the word practice is often used as a metonym to refer to a type of business in which a medical practitioner or group of practitioners provide care to patients. so, you might use the term “the practice” when you want to refer to such a business as a business or when you don’t want to specify a particular part of the business. for example, you could encourage patients to “contact the practice” without specifying which person or even which office to contact. your goal should be clarity. if the patients can contact any member of the staff, you can urge them to contact the practice. in general, you may wish to avoid unnecessary use of figurative language in a technical report, such as a clinical study protocol—especially if it is going to be translated. however, there is considerably more room for literary inventiveness in an opinion piece. in such pieces, authors may wish to express their own emotions and to evoke emotions in the audience, especially to underscore the importance and urgency of their message. in that situation, the writer may use figurative language for rhetorical effect. learn more metaphors, similes, and metonyms are not the only forms of figurative language. the silva rhetoricae web site (http://rhetoric.byu.edu/), maintained by dr gideon burton of brigham young university, provides an extensive list of figures of speech, all of which are named, defined, and categorized. many of these rhetorical figures have greek or latin names because they have been recognized since classical times to be valuable in persuasion. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: www.nottrivialbook.com; lthomas521@verizon.net international society for medical publication professionals april 12-14, 2021 virtual https://www.ismpp.org/annual-meeting association of independent information professionals april 14-16, 2021 virtual https://virtual21.aiip.org/ american copy editors society april 22-23, 2021 virtual https://aceseditors.org/conference american society for indexing april 30 to may 1, 2021 virtual https://www.asindexing.org/conference/2021-presentationproposals/ council of science editors may 3-5, 2021 virtual https://www.councilscienceeditors.org/events/upcomingevents/2021-cse-annual-meeting/ european medical writers association may 4-8, 2021 virtual https://www.emwa.org/conferences/future-conferences society for scholarly publishing may 24-27, 2021 virtual https://customer.sspnet.org/ssp/am21/home society for technical communication june 5-9, 2021 virtual https://summit.stc.org association of health care journalists june 24-27, 2021 austin, tx https://healthjournalism.org/calendar-details.php?id=2245 dia june 27 to july 1, 2021 virtual https://www.diaglobal.org/flagship/dia-2021 calendar of meetings please confirm with individual meeting hosts 2021 amwa medical writing & communication conference october 27-30, 2021 trends and opportunities for medical communicators www.amwa.org/conference http://www.amwa.org/conference http://rhetoric.byu.edu/ http://www.nottrivialbook.com mailto:lthomas521@verizon.net https://www.ismpp.org/annual-meeting https://virtual21.aiip.org/ https://aceseditors.org/conference https://www.asindexing.org/conference/2021-presentation-proposals/council https://www.asindexing.org/conference/2021-presentation-proposals/ https://www.asindexing.org/conference/2021-presentation-proposals/council https://www.councilscienceeditors.org/events/upcoming-events/2021-cse-annual-meeting/ https://www.councilscienceeditors.org/events/upcoming-events/2021-cse-annual-meeting/ https://www.councilscienceeditors.org/events/upcoming-events/2021-cse-annual-meeting/ https://www.emwa.org/conferences/future-conferences https://customer.sspnet.org/ssp/am21/home https://summit.stc.org https://healthjournalism.org/calendar-details.php?id=2245 https://www.diaglobal.org/flagship/dia-2021 v37 n1 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 4 abstract lori l. alexander is the 2021 recipient of american medical writers association’s (amwa) harold swanberg distinguished service award, which is given to an active member who has made distinguished contributions to medical communication or rendered unusual and distinguished services to the medical profession. sadly, lori lost a brief but courageous battle with cancer in june 2021. in the following pages, you’ll hear from lori alexander’s colleagues, friends, and her wife, deb. we hope you’ll gain insight into who lori was as a person, her passions, her professional accomplishments, and the immense mark she made on the field of medical communication. lori l. alexander was one of america’s most influential medical communicators. her work in medical communication, extensive service as a volunteer leader of the american medical writers association (amwa), experience as an educator within the field, and passion for health literacy and creating clear medical information empowered thousands of medical writers and editors, whose work in turn has touched the lives of millions of people. clear communication is essential to scientific research, meaningful patient-physician interactions, and better health outcomes. when the resources produced by medical communicators enable people to better understand their treatment options, it helps them make more informed health care decisions. medical writers engage in developing the required documentation for clinical trials and approvals of new drugs and medical devices, as well as with writing reports on trial results and implications. medical writers and editors also help prepare the millions of science, health, and medicine articles published each year. lori’s work in medical communication spanned a variety of settings and she was a master at editing, writing, and developing educational resources for health care professionals and lay audiences. she began her medical communication career as an assistant editor in the editorial department of lahey clinical medical center and later became a senior copyeditor of the journal of bone and joint surgery. in 1998 lori became assistant director of the publications department of the american society of clinical oncology (asco). in 2004 lori and deb founded editorial rx, inc, specializing in medical writing and editing, and publications development and management. in this capacity lori worked with medical and health-related associations, advocacy groups, research foundations, medical institutions, medical publishers, government agencies, and physician-authors. lori’s contribution to the field includes service both within and outside of amwa. she was also an active member of the editorial freelancers association and the center for plain language. the university of california san diego (ucsd) extension recruited lori to help set up and develop a medical writing and editing certificate program on regulatory writing, journal publications, continuing education, and grant writing. she was also an instructor of medical terminology and business communication at newbury college and she developed and led several amwa workshops, including “medical terminology” and “using principles of classical rhetoric to enhance medical communication.” lori joined the amwa staff after 6 years of service on the amwa board. lori understood the roles of volunteer leader and staff and the important synergy of the relationship in achieving organization goals. she called the opportunity to guide and manage the educational program at the association that had been “my professional home for nearly 20 years” an “opportunity of a lifetime.” working with her in both capacities was an exciting and enriching opportunity of my lifetime. the amwa staff enjoyed working with lori in both capacities, and we are incredibly grateful for her leadership, mentorship, and friendship. —susan krug, ms, cae, amwa executive director compiled by susan krug, ms, cae, and cynthia l. kryder, ms, mwc 2021 swanberg award tribute lori l. alexander, mtpw, els, mwc—a tribute conference http://www.amwajournal.org amwajournal.org 5lori l. alexander, mtpw, els, mwc—a tribute lori wore many hats at amwa: journal editor, chair of the annual conference programming committee and the education committee, workshop leader, head of the strategic planning initiative, president of the board of directors (bod), and most recently, amwa education director. i don’t know which hat was her favorite, but i do know she was thrilled and honored to be able to use her vision to propel amwa education into the future. i got to know lori after she invited me to join the amwa journal editorial board. her passion for amwa was obvious, and she was never shy about reminding us that we needed to create content for medical writers and editors in all work settings. lori was a masterful communicator. she loved words, and she loved to write, and she loved inspiring that same passion in others. among lori’s many gifts was her unique ability to recognize leadership skills in others. and once she got you to say “yes” the first time, she wouldn’t let go. many of you know what i’m talking about. lori was a quiet but forceful leader who encouraged people to use their talents, to move outside of their comfort zones, and to aspire to be more. she inspired us by her example. lori was first my colleague, but she quickly became my friend. i was inspired by her ability to always look forward—to that next webinar, to the next workshop, to the next conference, to the next trip to broadway. lori had a deep passion for giving and doing for others, and she did more than simply write a check. she regularly prepared meals for residents of a local shelter, and each year she bought christmas gifts for needy families. she was a remarkable, generous woman who found joy in sharing her gifts. the medical writing and editing community—and the world— is richer for having had lori in it. —cyndy kryder, ms, mwc, amwa president 2018–2019 lori would laugh at me for starting this with a quote from the dalai lama, but it seems so true to her and her legacy: “just as ripples spread out when a single pebble is dropped into water, the actions of individuals can have far-reaching effects.” — dalai lama xiv this tribute to lori reflects the effect of her life on us. obviously as her wife, friend, and collaborator, lori’s effect on me is profound. lori first turned my head in the late 1990s when she synthesized a complicated abstract into clear, understandable english. she was one of those rare people who can flow from copyediting to structural editing to document design and back. her elegant tables, nonredundant prose, and realistic timelines brought rigor and simplicity to work and life that was often messy and complicated. lori understood firsthand the need to integrate proven research results into patient care. two of her siblings were allied health professionals and her mother did triage admitting work at a local emergency room. like me, her passion at its core was writing. she wrote television screenplays in her 20s, had an agent who brought her promising close calls, and lived with a cat named malibu. but hollywood was not meant to be for lori, which was our gain in the field of medical communication. lori and i are essentially the same age, 2 months apart, and we are boston girls; we experienced the transition from paper to computers in medical literature in parallel time. in the 80s you would have found each of us wandering the stacks of the harvard medical library several days a month, checking references for our respective journals. we ate at the same lebanese-american food truck, went to the harvard coop for supplies, and drove up and down storrow drive to and from our respective homes. flash forward 10 years later and lori and i finally are working together and soon thereafter, become a couple after studiously not dating for a year as professional colleagues. we loved each other that much. by this time, i had joined amwa. i attended my first meeting in 1987 in boston and was hooked. i took to heart that to make medical writing a profession, you have to treat it as a profession. lori joined in the 90s, and, similar to her approach to everything she enjoyed and thought important, she was all in. and she had the skills, the vision, the camaraderie, and the humor to take us all along with her. lori alexander with susan krug, brian bass, and cynthia l. kryder http://www.amwajournal.org amwajournal.org 6lori l. alexander, mtpw, els, mwc—a tribute flash forward to the future—which was lori’s specialty as a leader—she was committed to creating and delivering amwa programs to meet the needs of medical communicators tomorrow as well as today. lori was a builder—of sentences, articles, daily meeting newspapers, departments, your member magazine, her own business, a life of travel, and community including the amwa community. she was a family woman and loved to see the world firsthand. she had actionable bucket lists. she took risks and had managerial courage. she was a powerful example of what you can do when you share your strengths with others. lori would want all of you to be successful, to make a difference, and to have fun doing it. for a small person, lori had huge footsteps and an even bigger heart. we all stand on her shoulders as we face the future without her. —deb whippen, amwa board of directors 2012–2014, editor and publisher, editorial rx, inc. those reading these words know that amwa’s mission is to promote excellence in medical communication and to provide educational resources in support of that goal. i have never known a person who exemplifies that mission more than lori alexander. rather than talk about what lori accomplished, i’d like to reflect on why and how i think she was able to achieve so much. lori had a deep love of language. not just words but all aspects: how words fit together, the structure of a paragraph, the nuance of verb tenses, how punctuation enhances clarity—don’t misuse a colon! seriously. lori’s love of language wasn’t based on a love of rules, being the smartest person in the room (even when she was), or detail obsession. it was grounded in shaping communication so that the intended recipient could receive the best understanding, period. whether writing or editing, every detail of every communication was under scrutiny. lori left no stone unturned to deliver her aim. and that brings me to the second part, the real magic of her work. that’s lori’s love of her fellow person. lori devoted both her career and her personal life to the pursuits that would bring the greatest benefit to others. i think this is why she and deb had such a perfect partnership—kindred spirits in the kindness and wisdom of their hearts. it pleases me to know that truly, it is lori’s work in the field of medical communication—through her legacy of mentees and the improvements she has made in the field— that will help future physicians and patients learn how to adapt to the advancements that are coming in care for brain tumors, other cancers, and other diseases. as a cancer survivor and a professional working in the field of medical education, i will continue to be inspired by my colleague and friend, and i know that is true of countless others. —lisa greaves, division director, educational meetings at american society of clinical oncology i still remember that first conversation i had with lori alexander in the early aughts roughly 20 years ago. she was interviewing as a candidate for editor of the amwa journal and i was leading the search committee. as impressive as lori’s experience and qualifications were on paper, meeting her by telephone that first time we spoke was unforgettable. lori was sharp, creative, innovative, and enthusiastic—not only about the journal, but about the medical communication profession itself. she embodied the collaborative spirit of amwa so completely that it was easy to get lost in all the ideas she proposed and directions she envisioned. however, it was her solitary strength and depth of purpose that kept you grounded and focused. lori went on to lead the journal to unprecedented heights, and she continued her leadership and service to amwa well beyond her 10 year editorial tenure. i always enjoyed hearing her speak, whether giving workshops or attending committee and board meetings. lori had the knack to bring people and ideas together, interwoven with the spark of creativity and a genuineness of mutual care and appreciation. lori left us far too soon. she made an indelible impression on me, both as a friend and a colleague in the organization we all love and support. —tom gegeny, ms, els, mwc, cmpp amwa president 2009–2010 deb whippen and lori alexander http://www.amwajournal.org amwajournal.org 7lori l. alexander, mtpw, els, mwc—a tribute lori gave me the big break i needed when i was beginning my freelance graphic design and medical illustration business. early in my career, my work consisted of mostly small jobs with medical organizations in boston. i met deb and lori while they were both working at the boston area office of asco, a global oncology organization, in the late 1990s. i really wanted to take on larger publication projects and lori offered me the opportunity to be the designer on the quarterly asco news publication. we worked well together, and with her recommendation and support, i went on to do many other asco publications, print collateral, and conference work, which was a huge boost to my career. when lori became editor for the amwa journal in 2003, she once again offered me a fantastic opportunity. that began my wonderful relationship with amwa, which has continued to the present. our close work together on many types of projects continued when she and deb started editorial rx. professionally, i was awed by her skills at planning, organizing, and executing projects. she had a strong vision for the amwa journal and we worked together with the leadership on a redesign. her attention to detail as an editor was top of the line and i learned so much from her. i am so grateful to have had lori in my professional life, but after working so closely together for so many years, we also became great friends, always sharing with each other what was happening in our lives day to day. personally, i admired what a beautiful adventurous person she was—always planning out her next bucket-list trip. she was warm and welcoming and had a wicked sense of humor. she loved to decorate for every holiday, which i loved to kid her about. i will miss her so much, but know she positively impacted not only my life but many others. —amy boches, graphic designer, amwa journal lori alexander was one of a kind and in many ways her contributions to amwa and the field of medical writing were immeasurable. she was never one to brag, or even talk about, her accomplishments. she just went about doing her job and finding ways to contribute her time and her wonderfully creative ideas, wherever needed. i had been an amwa member for more than 10 years before i met lori, and it wasn’t at amwa. i met her when, at the suggestion of a fellow amwa member, she offered me a freelance job working at the asco annual meeting as a reporter for the daily newspaper that they published during the meeting. it didn’t take long for me to see what a consummate professional lori was. working for the asco daily news was one of the most challenging and fulfilling freelance jobs i ever had; and when lori asked me back the next year, and the next, and the next, i knew i had finally made it as a freelance medical writer. i couldn’t have been happier when i learned that lori had accepted the position as editor of the amwa journal. based on my experience working with her at the asco conferences, i knew that amwa was about to benefit in ways we couldn’t imagine. and we did... i am grateful to have had the opportunity to both work for lori—through asco and her business, editorial rx, inc.—and with lori on the amwa journal and many of the projects she chaired. i could never say “no” to my dear friend lori, and every time we worked together, i learned something new. lori alexander made me a better medical writer, and her many contributions to the field of medical writing and amwa are truly immeasurable. —donna miceli, dlm writing services, retired freelance writer, editor & pr consultant lori was the consummate penguin fan. she loved everything about them. it was a highlight of her life to travel to antarctica to see them in their natural habitat. but i’ll get back to that in a moment. the swanberg award is such a fitting tribute to lori in recognition of her amazing career and innumerable accomplishments. like dr swanberg, lori was also a transformational leader of amwa. there was no role lori held that didn’t result in major change for the better. lori brought skill, expertise, and, importantly, a talent for uniting others to the table. there is a picture of lori in the photo gallery of her facebook page in which she’s sporting a mask that says, “less me and more we.” that singlehandedly describes lori’s leadership. ever self-effacing, she truly looked for ways to build bridges with others and to generate such enthusiasm for an initiative that many already-very-busy lori receiving an award in 2012 for 10 years as editor of the amwa journal. http://www.amwajournal.org amwajournal.org 8lori l. alexander, mtpw, els, mwc—a tribute people willingly jumped in to give of their time and talents. lori allowed people to be at their best—to offer their best ideas and their best work. and, like her beloved penguins, she overlooked difficulties and instead focused on what could be achieved, not on what couldn’t. you see, penguins don’t spend time worrying about not being able to fly, but they are excellent swimmers and effortlessly fly through the water. and one species uses the sun to navigate from land to sea, adjusting for the sun’s changing position in the sky throughout the day. in all these ways, penguins have adapted to the challenges their environment poses. lori did the same, but she also mobilized our profession to move in new and even better directions. lori set an incredible example for others, and she did so with a fair dose of good humor. i can’t think of anyone more deserving of amwa’s highest honor. —melanie fridl ross, msj, els, amwa president 2010-2011 i was fortunate to meet lori early in her amwa career. she told me that she wanted to get more involved in amwa and that she did. once lori set her mind to something, nothing stopped her—thus her lengthy list of amwa accomplishments. she had an affinity for education, and her contributions to amwa’s education program, in my opinion, will never be equaled and will live on through the many medical writers she influenced. i worked with her on multiple education initiatives, including the certification commission, in which she made major contributions as a subject-matter expert, including in item development. lori always said “yes” whenever someone asked her to help. when she became the amwa education director, for the first time, we had someone at headquarters who was an actual medical writer and who readily understood members’ needs. lori charted a new course to expand amwa’s educational offerings. her legacy to that program will continue, and we members will continue to be the beneficiaries. when i think of lori, i hear her infectious laugh and remember her stories. lori always had a story. in her workshop on classical rhetoric, she promoted the use of stories in scientific publications. that workshop caused me to rethink scientific writing, and i teach her philosophy to my students. lori said, “a story engages you. it taps into your imagination. it connects you with others. medical writing lacks stories.” she was correct, of course, and gave us simple guidelines for adding story to manuscripts—if only by just switching to first person or giving patients a voice. when i think of lori, i also hear her say, “if you have a minute, i’d like to run this idea i have by you.” that was the hook, and i was always honored to be part of team lori for whatever new idea she envisioned. lori often said how grateful she was for the opportunities amwa gave her to help do her job better, to network with colleagues, and to grow as a leader. what lori gave back, however, was legion. if every medical writer who benefited from lori’s wisdom planted a seed in her memory, a vast wilderness of flowers would be the result. the nobel laureate anatole france said, “to accomplish great things, we must dream as well as act.” lori did both, and she will be greatly missed… —marianne mallia, els, mwc, amwa president 2002–2003, 2010 amwa swanberg award recipient in an organization with more than its share of brilliant, talented, and generous members, lori quite simply was a rockstar. her commitment and passion for the mission of amwa were unrivaled. her imprint will be lasting. —victoria white, former editor-in-chief, amwa journal i have long felt that lori was a natural choice to receive the swanberg award. anytime amwa is mentioned, it is lori who pops into my mind. you would be hard-pressed to find another member who has devoted more time and energy to helping amwa live up to its mission. i first met lori when i was at a crossroads in my professional life. i had just left industry and entered the freelance life. at the 2011 amwa conference in jacksonville, i met deb whippen and she immediately got me involved in amwa florida and turned me over to lori who realized she had some “fresh volunteer material” to develop. she wasted no time talking me into volunteering on my first of many “lorirun projects.” lori was the mentor i had no idea i had always been searching for, but i am just happy i realized what i gift the universe had presented me when i needed it most. a project or team led by lori was sure to accomplish its goals and it was always rewarding to be a part of them. lori led with kindness and was always inclusive long before it lori and scooter. http://www.amwajournal.org amwajournal.org 9lori l. alexander, mtpw, els, mwc—a tribute was in vogue. she had a knack for taking you out of your comfort zone and getting you involved in areas that didn’t just get the job done for the organization, but left you rewarded with new skills for future use. you wanted to do more because she inspired you with all the confidence you needed to get the job done. lori was a naturally curious soul with a thirst for learning and a drive for teaching and sharing what she knew. she was passionate about storytelling as a vehicle for medical communication and as the master communicator, she was every bit the skilled listener as she was the gifted storyteller. it was always exciting to get one of those calls, “hi larry, this is what we are thinking about doing, and i think you would be a great fit.” i am grateful for each of those experiences. lori did a solid for our founder and award namesake, harold swanberg. we are so lucky for the legacy lori has left for us as a guide for the next leg of the amwa journey. —larry lynam, annual conference committee 2012–2018, 2018 president’s award recipient i can think of no one more deserving to receive the harold swanberg distinguished service award. lori alexander’s contributions to amwa vastly exceed the criteria of distinguished contributions to medical communication. i first met lori while attending an amwa bod meeting as a chapter delegate and later, i had the honor of joining the bod and serving alongside lori. i am just one of many that lori brought into her network, and i am honored. lori and i also worked together with ucsd to create and grow an educational program for new medical writers and editors. it leverages the multifaceted expertise of several amwa members including yeshi mikyas, donna simcoe, dikran toroser, noelle demas, and lynne friedmann. since its launch in 2016, the program has continued to expand and grew stronger. much of its success is attributed to lori, who in 2017 took a leadership role in the program and served as the program’s consulting director. on monthly faculty calls, she pushed each of us to continuously improve our courses, and she was a favorite of the students. lori brought leadership, grace, and a strong understanding of our field to the program. when she took the position of education director at amwa, lori ensured that she could continue to serve as the director of the ucsd program, and for that, we are all eternally grateful. the program itself has certified over 50 students. when she stepped away earlier this year, it took 2 folks to fill her shoes. her presence is and will be missed. no one could say no when lori asked, no one. what i recall is her sense of humor. if ever we were sitting next to each other, i knew i would be stifling laughter. i will always be most grateful for her friendship. her authenticity was rare, and her example will serve as guidance for me and so many others. may we honor her today and always with our work, with our welcoming community, and with authenticity. —r. michelle sauer gehring, phd, els. instructor, ucsd extension, amwa secretary 2020–2022 i was surprised when lori alexander asked me to join the amwa board during her year as president. i was also nervous and quite honored. i soon learned that lori had a gift for including others. many may shy away from inclusion, but lori embraced it. she always made room for others to contribute in their own way, all while providing support and lighting the path. i also learned that lori was highly productive on her own. she literally performed the work of many and made it look easy. i think this combination—including others and high productivity—is what allowed her to accomplish so much. i was able to witness lori’s craft up close, and i was astonished by her drive, compassion, and commitment to medical writing. she truly loved what she did, and this made work feel like play. amwa is blessed to have had lori leading on multiple fronts over the years, from the amwa journal to conference planning and education initiatives, to name a few. lori with her gavel for starting her term as amwa president 2016-1017. http://www.amwajournal.org amwajournal.org 10lori l. alexander, mtpw, els, mwc—a tribute undoubtedly, her departure leaves a void that cannot be easily filled, but her leadership is an inspiration that endures. it’s truly fitting for lori to be honored with amwa’s highest award. lori, thank you for being a wonderful mentor and friend. although you are greatly missed, it lightens my heart to think that you are spending time with penguins. —theresa singleton, phd, amwa board of directors 2016–2019 i first “met” lori when she emailed me in 2016 suggesting i submit an interest form for the amwa executive committee (ec) as she was starting her amwa presidency. the email ended with the postscript: “i noticed on your linkedin profile that you’re looking for an opportunity to join a nonprofit board—i hope amwa fits that!”—which i now know is so lori. i first met her in person in an elevator. i was so nervous, because she was and always will be a giant in our field (those who know us might chuckle, i’m almost a foot taller than lori). but lori was so genuine, warm, and caring that i quickly felt comfortable, and it wasn’t soon after that we became friends. just last week i found a card from a gift she gave my daughter who had a brain tumor in 2018—tears came to my eyes but smiles also came to my face. because she was president when i joined the ec, i’ll always think of her as the model amwa president; never did i imagine that we’d lose her during my presidency. lori will be so missed, but she will always be with us. —gail v. flores, phd, amwa president 2020–2021 i first met lori years ago when i was a delegate to the amwa board, and i must say i was instantly comforted by her warmth and inclusiveness. over the years, i’ve had a chance to work with lori on several initiatives while she was president of amwa and later as education director. each experience was not only an opportunity for me to learn something new and to grow my professional expertise, but also gave me the chance to inform others about the role public relations and marketing plays in the field of medical communication. lori understood that medical communicators work in a variety of settings and across multiple areas. she had the desire to develop educational resources to support members that work in the different niches within medical communication. when i think of an inclusive and servant leader for amwa, i think of lori. we as an organization are now reaping the benefits of lori’s passion and commitment to amwa. i can’t think of anyone more deserving to receive the 2021 swanberg award. i am comforted to know that her legacy will live on through amwa and will inspire many medical communicators along the way. —katrina r. burton, amwa president 2021–2022 lori was so many things to so many people. to me she was a dear friend, a valued colleague, a trusted leader, a generous resource, a joyful spirit, and a kind heart. but i think there’s one way to sum her up—lori was an accelerant. she always set my mind on fire with her energy and enthusiasm. working with lori when she was editor of the amwa journal, she brought so many innovative ideas to the table. nothing was impossible. she would light a match with a simple thought or suggestion that would ignite collaboration as it spread across the room. during her amwa presidency, lori fused the organization together behind a new governance structure that strengthened amwa while bringing it into compliance with evolving guidelines. as director of education, lori’s passion for teaching others fueled an explosion of new educational products and programs that will continue to serve amwa and the medical writing profession for years to come. receiving the 2021 harold swanberg distinguished service award for lori’s contributions to the medical communication profession is a great and well-deserved honor. the honor of knowing lori, working with her, and learning from her, is all ours. —brian bass, mwc, amwa president 2013–2014, 2017 amwa swanberg award recipient lori teaching at the 2018 amwa medical writing & communication conference. http://www.amwajournal.org contents v36 n4 winter 2021 177 164 0% 20% 60%40% project management 80% leadership skills collaboration skills/diplomacy effective communication technical / writing skills quality control other (please specify) 152 137 138 145 152 159 163 164 169 from the editor what’s coming to the journal in 2022 � michael g. baker features optimizing the value of regulatory medical writers � dylan harris, lisa chamberlain james, julia forjanic klapproth, brian bass, and angela russell winnier, on behalf of the amwa value of medical writing working group value of medical writing: the regulator’s perspective � julia cooper, lisa chamberlain james, joan affleck, brian bass, julia forjanic klapproth, and dylan harris, on behalf of the amwa value of medical writing working group value of medical writing: the regulatory writer’s perspective � dylan harris, cathy tyrrell, amy myers, cynthia carr, and karen l. fink, on behalf of the amwa value of medical writing working group effective communication between medical writers and creative teams: the secret condiment for a flavorsome sauce � andrea caricilli blotta calendar of meetings biography walter clement alvarez: physician • researcher • columnist � thomas a. lang social media how to make linkedin a career-building tool � lori de milto contents editor-in-chief michael g. baker, phd managing editor jennifer workman section editors practical matters qing zhou, phd, els regulatory insights jennifer bridgers, ms, mwc science series paul c. dolber, phd social media jennifer minarcik, ms statistically speaking thomas m. schindler, phd everyday ethics julie ravo, ba, ma members matters govindi (jaya) samaranayake, phd freelance focus ruwaida vakil, msc regular contributors freelance focus brian bass, mwc melissa l. bogen, els sherri bowen, ma, els lori de milto, mj cathryn d. evans gail v. flores, phd phyllis minick in the service of good writing laurie endicott thomas, ma, els editor at large haifa kassis, md editors in memoriam lori l. alexander, mtpw, els, mwc ronald j. sanchez 2021–2022 president katrina r. burton, bs 2021–2022 board liaison r. michelle sauer gehring, phd, els 2021–2022 staff liaison shari rager, ms, cae executive director susan krug, ms, cae graphic designer amy boches, biographics editorial office: managingeditor@amwa.org. instructions for authors available at: www.amwa.org/journal. advertising: contact marketing@amwa.org or (240) 239-0940. all advertising is subject to acceptance by amwa and should be for products and services relevant to professional medical communicators. amwa is not responsible for the content of advertising and does not endorse any advertiser or its products or services. subscription: the amwa journal is published quarterly. subscription is included with amwa membership. nonmember subscriptions cost is $75 per year. contact: american medical writers association, 30 west gude drive, #525, rockville, md 20850-4347. phone: (240) 238-0940; fax: (301) 294-9006; email: amwa@amwa.org. the amwa journal is in the mla international bibliography and selectively indexed in the cumulative index to nursing and allied health literature (cinahl) print index and the cinahl database. the opinions expressed by authors contributing to the journal do not necessarily reflect the opinions of amwa or the institutions with which the authors are affiliated. the association accepts no responsibility for the opinions expressed by contributors to the journal. ©2021 american medical writers association. all rights reserved, worldwide. issn 1075-6361 amwa journal mission statement in support of the mission of the american medical writers association (amwa) and to advance the broader profession, the amwa journal publishes content that reflects the interests, concerns, and expertise of medical communicators. its purpose is to inform, inspire, and motivate medical communicators. m o r e v36 n4 / 2021 173 regulatory insights “i can help you if you would just let me!”: the journey from vendor to trusted partner an interview with demetrius carter � diana henzel 177 practical matters the razor’s edge of predatory publishing an interview with jeffrey beall � mary kemper 182 members matters resilience: one family's history the skills and tools for organizing large amounts of discordant information into a cohesive story � judy stone 185 amwa news amwa, emwa, and ismpp promote ethical, professional medical writing in jama oncology letter to the editor � thomas m. schindler and gail v. flores from the president/inaugural address � katrina r. burton introducing the 2021-2022 board of directors � katrina r. burton think you have what it takes to join a world-leading team of medical writers? we’d love to speak with you. become a medical writing ninja visit us at www.trilogywriting.com writers@trilogywriting.com www.trilogywriting.com/trilotalk listen to our podcast available on apple podcasts, google podcasts, and spotify amwa journal / v36 n1 / 2021 / amwa.org 53 a m w a news from $800,000 to $1,600,000. amwa’s unrestricted shortand long-term investment reserve level of $1,800,000 on june 30, 2020, was within this targeted range. amwa’s restricted endowment and mcgovern funds totaled $205,200 and $169,000, respectively. financial position an organization’s financial position is reflected in its asset and liability holdings. amwa is well positioned to pay its obligations and plan for the future. total assets were $3,160,138 as of june 30, 2020, and the organization’s liabilities totaled $561,680. financial statement audit results abercrombie and associates, amwa’s independent auditors, expressed an unqualified opinion regarding their audit of the financial statements for the fiscal year that ended june 30, 2020. an unqualified opinion states that the financial statements present fairly, in all material respects, an entity's financial position, results of operations, and cash flows in conformity with generally accepted accounting principles. amwa continues to be in a secure financial position as it continues expanding member benefits and resources into the next fiscal year. the full audit report is available to amwa members upon request. acknowledgment thanks to calibre cpa group, pllc, for providing the financial data and the members of the 2019-2020 budget and finance committee for their review of reports and budgets: june baldwin, adriana caballero, alice pappas, leena patel, whitney smalley-freed and christine wogan, ann winter-vann (201920 amwa president), gail v. flores (amwa president-elect), and susan krug (amwa executive director). author contact: julie@biomedisysinc.com organizational donors ($800) gail v. flores perfectit individual donors ($80+) lori l. alexander saleh alqahtani jack aslanian brian bass bookworm editing services llc nicole cooper tracy craig elise eller kathryn emily r. michelle sauer gehring heather gorby douglas haneline jessica kiser laurie kozbelt susan krug cynthia kryder sheryl lallemand eleanor mayfield donna miceli jennifer minarcik marcello morgan margaret norris julie phelan john redue jessica reimer stephanie vargas ann winter-vann 80th anniversary donors 80th anniversary donors generously support amwa’s 80 years educating medical communicators. tax-deductible donations help amwa fulfill its mission to promote excellence in medical communication and provide education and resources in support of that goal. � to make a donation, please visit www.amwa.org/donations mailto:julie@biomedisysinc.com http://www.amwa.org/donations a m w a news gail v. flores, phd / 2020–2021 amwa president from the president back to education f all has always been my favorite season. nationwide, it’s “back to school” time. to me, the beginning of the school year represents a chance to make a fresh start, which many of us need this year more than ever. in amwa, each national leadership year begins in the fall, when the gavel is passed to the incoming president, officers are elected, and the board of directors (bod) is announced. we have so much to look forward to as an organization, and i’m excited to let president-elect katrina burton share amwa’s plans for the 2021-2022 year with you in future communications. late in the 2020-2021 amwa year, in june, the amwa community experienced a devastating loss with the death of lori l. alexander. lori was most recently amwa’s education director, as well as a previous amwa president and amwa journal editor, and had recently been nominated to receive the 2021 harold swanberg award. we truly lost a giant of our profession and a dear friend and mentor to so many. i first met lori when she emailed me to suggest i submit an interest form to join the amwa executive committee (ec) as she was starting her amwa presidency. the email ended with the following postscript: “i noticed on your linkedin profile that you’re looking for an opportunity to join a nonprofit board—i hope amwa fits that!”–which i now know is so lori. because she was president when i joined the ec, i will always think of her as the model amwa president; never did i imagine that we’d lose her during my presidency. two of lori’s many passions were amwa education and the amwa medical writing & communication conference. registration for this year’s virtual conference (oct 27-29) is open (https://www.amwa.org/ event/2021annualconf)—i hope to see you there! the conference committee, led by sarah dobney, has put together a fantastic program, building off the success of last year’s virtual conference. amwa is happy to announce that this year’s event will include 2 days of preconference workshops, and we are so grateful to all of the workshop leaders who were able to adapt their workshops to a virtual format. workshops have always been a huge part of amwa education, and lori would be so pleased to see how quickly the spots have been filling up. let’s get back to education! at the conference, i have the honor of presenting the amwa president’s award to dikran toroser, phd, cmpp. be sure to read my article about dikran in this issue of the amwa journal. dikran has been a devoted amwa volunteer for several years. volunteering is critical to the success of amwa, and we are so thankful for all of our volunteers at the local, chapter, and national levels. if you haven’t volunteered for amwa, i hope you will consider it. i’m so glad i replied to lori’s email 5 years ago with an enthusiastic “yes!” volunteering to serve on the national ec and bod has been so fulfilling for me, and even though this year has been particularly challenging, i would do it again and again if i could. yours in amwa, gail amwa journal / v36 n3 / 2021 / amwa.org 127 https://www.amwa.org/event/2021annualconf)%e2%80%94 https://www.amwa.org/event/2021annualconf)%e2%80%94 amwa journal / v36 n2 / 2021 / amwa.org 57 you and i as medical communicators are fortunate to be living in a time that reasonably can be characterized as a medical renaissance period. meaningful, rapid advances in research, preventive, and treatment-oriented medicine are in evidence not just in our professional but also our personal lives. witness the emergence of not one but multiple covid-19 vaccines that have been developed and approved in a strikingly short period of time relative to how long previous vaccines have taken to go from virus identification and characterization to vaccine candidate development to shots in arms. with recently embraced messenger rna technology, as just one example of contemporary research-based medical advancement, have we vanquished the typical 10+ year timeframe to develop a safe and effective vaccine? multiply this concept across tens of thousands of areas of medical advancement and you grasp the magnitude of our progress. simply put, we have the privilege of contributing to and reporting on the fruits of this renaissance. our role as medical communicators is to inform, educate, and contribute to the scientific body of knowledge during this period of rapid and prolific advancements. although the opportunity is exciting and a privilege, the sheer volume of information to which we are exposed, need to absorb, and operationalize is daunting. regulations governing the development of diagnostics, devices, and therapeutics are evolving rapidly in the united states and around the world, thousands of medical journal articles are published each day in english alone, and medical practice standards are changing at an unprecedented rate. thus, the skills required to be a medical communicator are substantial—not only scientific and linguistic, but also interpersonal, with a capacity for prioritizing and juggling multiple projects, adapting to change, and adhering to tight deadlines. it is a rare individual who can thrive as a modern day medical communicator. whether working in regulatory writing, scientific publications, health communication, continuing education, or promotional writing, we face the ongoing challenge of getting our messages to our often information-overwhelmed and time-constrained audiences quickly, clearly, and meaningfully. so, i ask, what does the amwa journal do to help you thrive as a medical communicator? we will continue to provide opportunities to learn from and connect with peers, practical tools to do your job, and insights into ethical concepts, regulatory issues, scientific matters, and other topics. key upcoming goals are to provide improved access to our content via an enhanced digital presence, emphasize the value of our diversity across a range of indicators, and further connect with our medical communication counterparts around the world. theme issues, new regular columns, and forward-looking topics on medical communication also are in the works. in coming issues, you will hear further from me on our progress in these areas. as the proud tradition of the amwa journal continues with a new editor and my sincere appreciation to jim cozzarin and the editors before him, the top-notch editorial team and i welcome your contributions, insights, and, yes, constructive criticism. serving our audience with a spirit of information-sharing, collaboration, and mutual support will continue to be guiding principles of the amwa journal. yours in medical communication excellence, —michael author contact: journaleditor@amwa.org first word from the editor michael g. baker, phd mailto:journaleditor@amwa.org v37 n3 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 3 michael g. baker, phd editor-in-chief from the editor amwa, like numerous organizations sensitive to the needs of its members, has embarked on an initiative to explore internal diversity, equity, and inclusion (dei). in this issue, we describe amwa’s commitment to dei through an initiative including the formation of a diversity & inclusion assessment task force. we also examine the makeup of our members via a summary of our most recent prior member survey in a piece titled “amwa: who we are.” a new survey of amwa members, the 2022 dei survey, has been distributed, and we encourage you to complete it soon if you haven’t already. results from this survey will be analyzed by the diversity & inclusion task force and thus will inform upcoming dei efforts. additionally, in this issue we have dei-related pieces on embracing accessibility and avoiding bias in accredited continuing education. in a future issue, we will return to the topic of dei to evaluate what we have learned and the enhancements to the organization that have come from amwa’s important initiative. yours in medical communication excellence, michael in november 2021, the amwa board of directors approved the creation of a diversity and inclusion (d&i) assessment task force. the charge of the task force is to analyze membership data and receive member input to help determine the current status of the organization’s d&i; identify deficiencies, needs, opportunities, and challenges related to d&i; and recommend initial strategies to enhance d&i efforts within the organization. the response to a call for volunteers in january and february of 2022 was positive, and several amwa members expressed their interest in serving on the task force. task force members were selected with consideration of their diverse perspectives, backgrounds, and experience with d&i initiatives. the task force first met virtually in march, and developed a diversity, equity, and inclusion (dei) survey that launched in august. the goal of the survey is for amwa to gain an understanding of who our members are and what our members need with respect to dei within the organization and in their professional lives. gail v. flores, phd / amwa diversity and inclusion assessment task force chair an update from the amwa diversity and inclusion assessment task force http://www.amwajournal.org v37 n4 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 44 “a word after a word after a word is power.” – margaret atwood words are powerful. they may deceptively look like simple little strings of letters, but they hold the tremendous power of influence. the words we choose—and where we place them—influence thoughts, emotions, and behaviors. clear words support clear thinking. and clear writing and clear thinking go hand in hand. yet, some writers will throw words on the page, hoping that readers will “get the idea.” but when you use words that are ambiguous, inaccurate, or imprecise, you encourage ambiguous, inaccurate, and imprecise thinking. this carelessness can cause death by a thousand cuts—each word misuse can chip away at the clarity and credibility of the work. this chipping away can involve any one of the hundreds of thousands of words in the english language. but as a professional editor, i have noticed 5 words that are most commonly misused in medical writing: utilize, increase, level, while, and comprise. utilize many writers write utilize as a synonym for use. but these words have different meanings. use generally means to put something into action or service, whereas utilize means to make use of. although these definitions may seem similar, the definition of utilize can suggest the discovery of a new, profitable, or practical use for something. as a general example, imagine—or maybe you can simply recall a recent memory—that you need to remove ice from your windshield, but you don’t have an ice scraper. you might utilize a kitchen spatula for the task. the spatula was not designed to remove the ice, but it does the trick. in science and medicine, you might utilize something for a purpose that it was not designed to fulfill, such as a petri dish for storing office supplies or a belt for a medical emergency. to ensure your writing is clear, default to writing the word use, and only write utilize when the term is the more accurate choice. better yet, skip the word utilize altogether, and stick with the more readable word use, which can always replace utilize. examples the researcher used a petri dish to grow bacteria. the researcher utilized a petri dish to store paperclips on their desk. the researcher used a petri dish to store paperclips on their desk. the emergency responder used a band of rubber as a tourniquet. the emergency responder utilized a belt as a tourniquet. the emergency responder used a belt as a tourniquet. increase many writers use the term increase (or, conversely, decrease) to describe differences in data. however, they do not always consider nuances in the meaning of this term. increase means to make or become progressively greater in size, amount, number, or intensity. based on this definition, increase infers a change over time or a cause-effect relationship. but what many writers do is misuse increase to describe differences between groups of data. most often, this misuse looks like increase paired with versus, than, compared to, or compared with. in these cases, the more accurate phrasing would be to use higher or greater. to ensure accuracy in your writing, only use increase when referring to changes over time or a cause-effect relationship. and use higher or greater to refer to differences between groups of data. examples the prevalence of diabetes increased from 0.93% in 1958 to 7.4% in 2015. epinephrine increases heart rate and cardiac output. urine albumin was higher in patients with kidney disease than in healthy patients. the concentration of red blood cells was greater in patients treated with the drug versus those who took a placebo. high sugar consumption for 4 weeks increased body weight by 1 pound each week. crystal r. herron, phd, els / redwood ink, llc, san rafael, ca the 5 most commonly misused words in medical writing (according to an editor) conscious writing http://www.amwajournal.org amwajournal.org 45the 5 most commonly misused words in medical writing the drug increased liver function in patients with hepatitis c. level some writers use level as a synonym for the words amount, concentration, or content. these latter 3 words have fairly simple definitions. amount means the total number or quantity. concentration means the amount of a component in a given area or volume. and content means the amount of a specified material. but the definition of level is not as simple. in fact, level has several meanings, including a concentration of something, a position in a scale, a measurement or index of altitude, or the magnitude of a quantity related to another value. level can also be used to refer to even or unvarying height, or to a device that helps to establish a horizontal line or plane. all these different meanings can create confusion for readers. to ensure that the writing is clear and easy to understand, default to using amount, concentration, and content. only use level when no other word will do. examples the treatment increased the concentration of antibodies in the blood stream. the drug reduced the amount of tumor necrosis factor. the bone was leveled during the osteotomy. while while is another word that can trip up writers. many writers use while, although, and whereas interchangeably. but while is not an accurate synonym for although or whereas. although means in spite of something or even though, and whereas means on the contrary or in view of. these definitions are fairly straightforward. the definition of while is not as straightforward because the word has multiple meanings. while can mean during a certain time, as long as, on the other hand, and at the same time as something. these definitions mean that while can sometimes be used instead of although or whereas, but not always. even still, why risk confusing readers by making them figure out which meaning of while you intend? to ensure clarity, use while only when referring to time. otherwise, use a term with a more precise meaning, such as although or whereas—or even a more readable word such as and or but. examples the pharmacist prepared the prescription while the patient waited in the lobby. although the patient adhered to the treatment plan, their insomnia persisted. drug a reduced blood pressure by 10%, whereas drug b reduced blood pressure by 15%. the resident performed the surgery, and the attending oversaw the procedure. the drug slowed heart rate, but it did not lower blood pressure. comprise many writers misuse the word comprise in their writing. how? they erroneously follow comprise with the word of. in these cases, writers are likely confusing comprise with the term compose. but these terms have opposite meanings. comprise means to include or be made up of (ie, a comprises x, y, and z), whereas compose means to form by putting together or to constitute (ie, x, y, and z compose a). to give compose a similar meaning to comprise, the word must be sandwiched between a weak “to be” verb (eg, is, are, was, were) and the word of (eg, was composed of). alternatively, writers may use comprise as a synonym for consists. unlike with compose, comprise and consists have similar meanings. comprise means to include or be made up of, and consists means to be composed or made up of. but, grammatically, only the word consists should be followed by the word of. to ensure clarity and accuracy, use comprise without of, or use consists instead. and if you are tempted to use the sandwiched form of compose, stick with either comprise or consists to reduce the word count and give your sentence a little readability boost. examples the complex is composed of 3 proteins. the solution consists of 4 chemicals. the team comprises a physician, nurse practitioner, and resident. keeping up with change language constantly evolves, so the meanings of these words and how they are used may change in the future. the key is to stay updated on these changes so that you can use the most explicit, accurate, and precise words in your writing. in this way, you can harness the full power of words to craft clear writing that supports clear thinking and credible work. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: crystal.herron@redwoodink.com http://www.amwajournal.org v37 n3 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 34 abstract the american medical writers association (amwa) third annual medical writing executives forum brought together executives of medical writing departments at some of the world’s top biopharmaceutical companies to discuss topics of urgent relevance to the companies that employ regulatory medical writers, those who manage regulatory medical writing teams, and regulatory medical writers themselves. participants identified and discussed many of the challenges and opportunities facing the industry today. in 2018, the american medical writers association (amwa) launched the amwa medical writing executives advisory council for the purpose of maintaining a connection between pharmaceutical and biotechnology department heads and the amwa board of directors. the council comprises senior-level professionals whose responsibility it is to recruit, train, and manage medical communicators. members of the council represent some of the world’s top health-science, pharmaceutical, and biotechnology companies as well as several companies that provide regulatory medical writing and consulting services. the council acts as a sounding board on issues such as workforce trends, training programs, and technologies that have an impact on the medical writing field. council members also provide guidance on and participate in the annual amwa medical writing executives forum. the third annual invitational medical writing executives forum was held virtually on october 25, 2021. joan affleck, mba, els, associate vice president and head of medical writing at merck & co., chaired the forum. a list of forum attendee companies is provided in the table. the theme of the forum was igniting leadership, innovation, and resilience in medical writing. participants divided into 5 breakout groups, each addressing a specific topic pertaining to the value of medical writing, next-generation leadership, the changing medical writing environment, recruiting and retaining medical writers, or leading in times of change. this article reports the key opportunities, challenges, insights, observations, and recommendations of the forum participants. brian bass, mwc / bass global, inc, fort myers, fl amwa’s third annual meeting of medical writing executives tackles value, leadership, change, recruitment, and retention amwa news • alnylam pharmaceuticals • american medical writers association • astellas pharma global development, inc. • bass global, inc. • bioforum group • boehringer ingelheim pharma gmbh & co. kg • bristol myers squibb • certara synchrogenix • eli lilly and company • encore biomedical communications llc • endo pharmaceuticals • genmab • gilead sciences, inc. • greenwich biosciences, inc. • harpoon therapeutics • icon plc • janssen r&d, johnson & johnson • karen l. fink medical and regulatory writing • merck & co., inc. • moderna, inc. • novartis pharmaceuticals • parexel • pfizer inc. • praxis precision medicines • regeneron pharmaceuticals, inc. • roche diagnostics • rrd international, llc • sarepta therapeutics, inc. • seqirus • syneos health • synterex, inc. • takeda pharmaceutical company limited • trilogy writing & consulting • ultragenyx pharmaceutical inc. • whitsell innovations, inc. table. 2021 medical writing executives forum attendee company list http://www.amwajournal.org amwajournal.org 35amwa’s third annual meeting of medical writing executives reviewing data/insights from the value of medical writing surveys amwa formed a working group in 2021 to work toward defining and quantifying the value of regulatory medical writers. the value of medical writing working group includes 3 subgroups: engagement with regulatory health authorities, survey development, and literature search and assessment of the amwa training outline and the dia competency model. the efforts of the working group are ongoing, and initial findings have been reported.1-3 during the 2021 amwa medical writing executives forum, the participants in this breakout group discussed several topics based on the working group’s efforts to date. using the data a key finding of the working group’s efforts that participants in this breakout group discussed is the need to educate others about the value of medical writers in the regulatory field. their recommendations included • leveraging the working group’s findings to start conversations with company managers and encourage investment in the medical writing team. • emphasizing to all stakeholders involved in the medical writing process that regulators prefer brevity; larger documents are not necessarily better. • educating subject matter experts, who are stakeholders and contributors to the medical communication process (eg, biostatisticians, clinicians, pharmacovigilance physicians), that medical writers are an important part of the regulatory communication process. data that were unexpected/surprising the survey of regulatory medical writers conducted by the working group found that many regulatory medical writers feel undervalued. the working group provided insight into how companies that employ regulatory medical writers can promote professional growth and job satisfaction. participants in this breakout group recommended increasing opportunities for medical writers to gain soft skills training, providing more opportunities for medical writers to grow into leadership roles, and exploring mentorship programs to promote collaboration and leadership. the breakout group participants noted that today’s medical writers seem to be more willing to take the lead, which is an asset to help improve collaboration with other stakeholders in the communication process. participants noted the ability to collaborate is as important as the ability to lead. although not surprising, participants in this breakout group acknowledged that in the united states and some (but not all) other countries, women form the majority in the field of medical writing. the group proposed an effort to explore what may be holding men back from pursuing a career in medical writing and how they might be encouraged to do so. communicating the data initial findings of the working group have been published in the amwa journal 1-3 and presented at the amwa 2021 medical writing & communication conference. efforts are underway to also present findings of the working group at upcoming meetings of the european medical writers association and the dia, as well as at the amwa 2022 medical writing & communication conference acknowledging the growing need for qualified, professional medical writers, participants in this breakout group proposed reaching out to high schools, colleges, and universities to increase awareness about the medical writing profession and encourage students to consider a career in medical writing. currently missing from the value story participants in the breakout group expressed that a granular definition of quality is needed to provide a uniform and consistent target for all stakeholders to expect, measure against, and achieve. the breakout group thought it would be especially helpful for managers to know how quality affects the return on investment in medical writing in terms of the time, money, and resources invested. understanding the dynamics of employing staff compared with contract or freelance medical writers would also be helpful for decision makers. developing the next generation of leaders for medical writing teams the dynamics of leadership and the characteristics of an effective leader are continually evolving. this breakout group considered the skills, tools, and opportunities that will likely be needed by tomorrow’s leaders of medical writing teams. key skills for tomorrow’s aspiring leaders the breakout participants acknowledged that not all medical writers want to become leaders in the traditional sense of managing others, yet they agreed that all medical writers, regardless of their aspirations, will benefit from mastering the soft skills required to lead as an individual expert contributor. these soft skills include • flexibility • problem solving • collaboration http://www.amwajournal.org amwajournal.org 36amwa’s third annual meeting of medical writing executives • diplomacy • curiosity • agility • resilience • project management an ideal way for someone to learn effective leadership skills is by observing an effective leader. seeing firsthand what an effective leader does to inspire and guide their team and how they respond to challenges, provides aspiring leaders with the opportunity to see the key skills they need in action. the next step is to give aspiring leaders the opportunity to practice and internalize these newly learned skills in a safe environment in which they can challenge themselves, make mistakes, and build confidence. tools for tomorrow’s aspiring leaders for medical writers who aspire to someday lead others, participants in this breakout identified several tools they will need to lead their regulatory medical writing teams. at the top of the list, leaders must have the trust of their team members, the ability to communicate with them clearly and directly, and leadership consistency. leaders of medical writing teams must be able to provide positive feedback and reinforcement, ideally in the moment when such feedback is appropriate, and constructive feedback discretely when warranted. making sure everyone on the team has a voice and uses their voice to express their ideas, needs, and opinions is another important tool for team leaders. being flexible with how people work can empower medical writers on the team to optimize their productivity while reducing workand/or life-related stressors. autonomy is another important tool identified by the breakout participants. team members should be given control of their own work when possible. ownership—even of just a small piece of a larger project—fosters engagement. opportunities for tomorrow’s aspiring leaders today’s leaders must make clear where opportunities for leadership training can be found within the organization, and reward those who are curious and aspire to become leaders by facilitating such training. those who are training aspiring leaders should get to know the individuals they are training and their desired career paths so they can be guided appropriately. mentorship is a powerful teaching tool, enabling aspiring leaders to learn by example. leadership desires may vary, and it is important for today’s leaders to keep this in mind. whereas, some medical writers aspire to a management track, others may aspire to leadership in a technical track. likewise, a career path is different from a development path, and it is important for today’s leaders to know the difference when providing guidance to tomorrow’s aspiring leaders. changes in the medical writing environment in this breakout group, participants identified changes that are currently taking place in the medical writing environment and discussed what medical writers can do address them. they grouped the changes taking place into 3 categories: • financial demands • technological innovations • team challenges financial demands breakout group participants noted the current demand for cost savings in their medical writing departments, which affects internal and external resource utilization. there is an added burden of internal resource management and oversight. increasing demands on the costs associated with managing outsourced medical writers includes demanding that outsourced medical writers self-manage their associated costs. on the staff side, there is currently a salary competition taking place in which managers are challenged to keep costs down while paying appropriately for qualified staff resources. technological innovations technology enables medical writing teams to eliminate some of the more mundane tasks and increase efficiency, especially in regulatory writing with the use of standardized templates. technology has changed the way teams interact with medical writers and not all of it is positive or useful. overly customized software can be well intentioned but overly burdensome for medical writers to use. it is incumbent upon managers to determine the level of technology that best meets the needs of the team and the work environment without overcomplicating processes. although it may seem that standardized technologies cannot be applied to the unique requirements of rare disease indications, a similarly unique or specialized use of technology may not be required. the breakout group participants also discussed the differences between logic-based and artificial intelligence-based technologies and agreed that more information is needed to choose the appropriately technology for a particular application or team. http://www.amwajournal.org amwajournal.org 37amwa’s third annual meeting of medical writing executives team challenges challenges experienced by medical writing teams add expense and time to a project. templates can help streamline these processes, provided they are not too individualized. regulatory medical writers must keep in mind that they are writing for a health authority audience, not for subject matter experts. two major challenges faced by regulatory medical writers concern document brevity and timelines. regulatory reviewers have said they want documents to be clearer and more concise, but medical writers typically lack the authority to impress this upon other stakeholders in the document development process. verbose documents also take more time to produce, which contributes somewhat, but not solely, to the second challenge of timelines. medical writers rarely have influence over the timelines that drive their work, and when pushed to meet timelines that may be unrealistic to the task, can experience burnout and possibly even stress-related injuries. what medical writers can do the breakout group participants identified ways in which medical writers can address these changes taking place in the regulatory environment. these include • clarifying the role of medical writers to stakeholders, some of whom who simply want scribes. • elevating the visibility of the medical writer as a vital member of the team. • engaging medical writers in setting timelines and giving them confidence and authority to push back against unrealistic deadlines. • conducting after-action reviews with the team to identify what went right and discuss opportunities for improvement. • highlighting transparency initiatives to help with standardization, use of templates, and leaner authoring. recruiting and retaining medical writers participants in this breakout group discussed turnover rates, the key attributes to look for when recruiting medical writers beyond writing skill, interacting with recruiters, training programs, and methods for recognizing, remunerating, and retaining top talent. turnover some companies have experienced attrition exceeding the rate of onboarding new employees, with turnover rates among medical writers reportedly as high as 30%. burnout is a large contributor to turnover, with some medical writers moving to freelance work to achieve a better worklife balance while others fear moving out of the company environment due to stability. another contributor to turnover is the disparity in position leveling across companies, which may make it enticing for staff medical writers to move from a larger pharmaceutical company to a smaller biotechnology company that may be recruiting at higher positions and offering higher salaries. key attributes to look for when hiring medical writers beyond writing skill, the breakout group participants identified a range of key attributes for hiring managers to look for when recruiting medical writers: • ability to work remotely • well-rounded document experience • contribution to a diverse team • innovative thinking, particularly concerning adoption of automation • emotional intelligence during the hiring process, some companies engage panels to interview candidates, which can be intimidating and time consuming. other companies have considerably more expedited interviewing processes. the interview is especially important because it provides candidates an opportunity to talk the talk and show what they truly know. many companies are focused on ensuring diverse slates of candidates for open positions as well as diverse interview panels. building diversity strengthens the quality of a good medical writing team and can take the team to new levels of innovation including being able to manage challenges from different perspectives. companies that require writing tests vary between in-person and automated platforms. it was noted that writing tests can be perceived as demeaning by more-experienced medical writers who may subsequently decline and be lost as potential candidates. developing an experience grid may make it easier for hiring managers to determine and compare candidates’ true experience rather than reviewing cvs. interacting with recruiters participants agreed that personal recommendations and referrals are best for identifying qualified candidates. companies have had varying degrees of success using internal and external recruiters and have found that recruiters themselves need training on the skillsets required to be a successful medical writer. http://www.amwajournal.org amwajournal.org 38amwa’s third annual meeting of medical writing executives training several breakout group participants reported that their company provides training programs in the form of apprenticeships, writing academies, and summer internships. university training programs are needed, as well as efforts to educate students about careers in medical writing. retaining top talent bonuses, career ladders, and work-life balance are among the tools companies can use to retain top medical writing talent. this may include monetary and gift award programs, retention bonuses, and offering clear development and leadership opportunities. it can be challenging when an employee’s drive for advancement exceeds the company’s established processes and timelines for promotion. work-life balance is an important consideration for staff medical writers and may include opportunities for parttime work and personal time off. in the european union, it was suggested that most regulatory medical writers are part-time. as a result, companies and staff must adapt to maintain workflow and timelines, such as document sharing among team members. having a reliable group of backup writers can also help. leading teams during a time of constant state of flux and ambiguity participants in this breakout group discussed the role of team leaders in managing change within their medical writing departments, and how managers can help affect change within their teams and with outside vendors. managing change change is constant. critical factors in managing change are transparency, community, and trust. managers of medical writing teams can best manage change by being upfront and honest, present and calm, transparent, and realistic (ie, not superficially or unrealistically positive). teams tend to absorb and then radiate the mood of their environment, whether that mood is calm or negative. managers should lead by example at all times and especially when times are tough. team managers should be honest about what they know and do not know to avoid team members thinking that information is being kept from them. it is easier to get a team to embrace, or at least accept, change when they understand why it is needed or happening. it can be helpful to discuss the opportunities that change may bring. however, change should not necessarily be normalized, such as when a key support structure is no longer in place. the covid-19 pandemic provides an example of this, when schools were no longer meeting in person and employees began working from home with their children learning from home. affecting change affecting change within a medical writing team is challenging and time consuming for the team manager. managers must address the concerns, expectations, and needs of the team members and implement the necessary changes while also maintaining the team’s focus on the project tasks, goals, and timelines at hand. providing the information medical writing teams need to understand and be a part of the change will help suppress the speculation and rumor that might otherwise persist. engaging the assistance and support of human resources when relevant can also be helpful. managers must be cognizant of the impact changes can have on team members. for example, working from home during the covid-19 pandemic fostered greater productivity, but it also led to higher rates of burnout as staff found themselves working longer hours. some breakout group participants said they provide opportunities for their team members to recharge, including offering mental health days that can be branded as “days of reflection” or “curiosity days.” change is not forever, and the medical writing team may be reassured to know that a company’s or a department’s response to change can evolve if something does not work as well as planned. change can also be difficult for vendors, whom some perceive as threats rather than members of the team. it is important to match the expectations of the team and the vendor at the start of the relationship and ensure goals are aligned. some participants in the breakout group noted that they invite their contract medical writers to team meetings to foster a collegial atmosphere built on familiarity, trust, and cooperation. connecting vendor members of the team with sponsor members can help build and strengthen these relationships. in dealing with vendors during times of change, once again, communication is the key to success. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: brianbass@bassglobalinc.com references 1. harris d, james lc, klapproth jf, bass b, winnier ar. optimizing the value of regulatory medical writers. amwa j. 2021;36(4): 138-144. 2. cooper j, james lc, affleck j, bass b, klapproth jf, harris d. value of medical writing: the regulator’s perspective. amwa j. 2021;36(4):145-151. 3. harris d, tyrrell c, myers a, carr c, fink kl. value of medical writing: the regulatory writer’s perspective. amwa j. 2021;36(4): 152-158. http://www.amwajournal.org 52 amwa journal / v36 n1 / 2021 / amwa.org a m w a news amwa annual financial report, 2019-2020 julie phelan, md, mba / 2019-2020 amwa treasurer it has been a pleasure serving as treasurer for the american medical writers association (amwa) over the past year, and i am pleased to provide this financial report for the 2019-2020 fiscal year, which ended june 30, 2020. i begin this report acknowledging that during the last 2 quarters of the fiscal year, the covid-19 pandemic caused severe disruption to everyday life and a recession. the leadership of amwa quickly put a plan in place to minimize the impact of the pandemic. amwa staff successfully converted to a remote work environment, and expenses were curtailed. meetings and travel plans were cancelled, and vacant staff positions were put on hold. the success of the 2019 annual conference in san diego, popularity of live webinars, increase in membership, and careful management of expenses helped to sustain amwa through this uncertain time. the full financial effects of the covid-19 pandemic may not be experienced until next year. financial performance amwa’s net income for the 2019-2020 fiscal year was $448,106, with significant investment gains contributing to the results. revenues overall, revenues exceeded budget expectations by 6%, largely because of the success of the annual conference. membership income, annual conference income, and education and certificate program income continue to be amwa’s major sources of revenue, providing 89% of amwa’s program revenue. net investment income of $115,074 accounted for 5% of amwa’s total revenue (figure 1). expenses amwa invests in programs, products, and services that bring value to members and the medical writing community. overall, expenses were under budget by 10% for the fiscal year. total program expenses for the fiscal year were $1,762,592, with 31% of the expenses going to produce the annual conference, 25% of expenses being used to fund member services and benefits, and 17% of expenses funding the education program including the certificate program and online education (figure 2). reserves reserves are the accumulation of funds over time that enable an organization to withstand an emergency or to invest in new mission-related initiates. unrestricted reserves of 6 to 12 months of annual operating expenses represent a standard target for not-for-profit organizations. with budgeted annual operating expenses of $1,615,950 for the fiscal year from july 1, 2020, to june 30, 2021, the target for amwa’s reserves ranges figure 1. sources of program revenue for the fiscal year that ended june 30, 2020. figure 2. sources of major program expenses for the fiscal year that ended june 30, 2020. amwa annual financial report, 2019-2020 julie phelan, md, mba / 2019-2020 amwa treasurer it has been a pleasure servicing as treasurer for the american medical writers association (amwa) over the past year, and i am pleased to provide this financial report for the 2019-2020 fiscal year, which ended june 30, 2020. i begin this report acknowledging that during the last 2 quarters of the fiscal year, the covid-19 pandemic caused severe disruption to everyday life and a recession. the leadership of amwa quickly put a plan in place to minimize the impact of the pandemic. amwa staff successfully converted to a remote work environment, and expenses were curtailed. meetings and travel plans were cancelled, and vacant staff positions were put on hold. the success of the 2019 annual conference in san diego, popularity of live webinars, increase in membership, and careful management of expenses helped to sustain amwa through this uncertain time. the full financial effects of the covid-19 pandemic may not be experienced until next year. financial performance amwa’s net income for the 2019-2020 fiscal year was $448,106, with significant investment gains contributing to the results. revenues overall, revenues exceeded budget expectations by 6%, largely because of the success of the annual conference. membership income, annual conference income, and education and certificate program income continue to be amwa’s major sources of revenue, providing 89% of amwa’s program revenue. net investment income of $115,074 accounted for 5% of amwa’s total revenue (figure 1). figure 1. sources of program revenue for the fiscal year that ended june 30, 2020. membership 35% annual conference 38% education/certificate program 16% all other revenue 11% expenses amwa invests in programs, products, and services that bring value to members and the medical writing community. overall, expenses were under budget by 10% for the fiscal year. total program expenses for the fiscal year were $1,762,592, with 31% of the expenses going to produce the annual conference, 25% of expenses being used to fund member services and benefits, and 17% of expenses funding the education program including the certificate program and online education (figure 2). figure 2. sources of major program expenses for the fiscal year that ended june 30, 2020. reserves reserves are the accumulation of funds over time that enable an organization to withstand an emergency or to invest in new mission-related initiates. unrestricted reserves of 6 to 12 months of annual operating expenses represent a standard target for not-for-profit organizations. with budgeted annual operating expenses of $1,615,950 for the fiscal year from july 1, 2020, to june 30, 2021, the target for amwa’s reserves ranges from $800,000 to $1,600,000. amwa’s unrestricted shortand long-term investment reserve level of $1,800,000 on june 30, 2020, was within this targeted range. amwa’s restricted endowment and mcgovern funds totaled $205,200 and $169,000, respectively. financial position an organization’s financial position is reflected in its asset and liability holdings. amwa is well positioned to pay its obligations and plan for the future. total assets were $3,160,138 as of june 30, 2020, and the organization’s liabilities totaled $561,680. financial statement audit results abercrombie and associates, amwa’s independent auditors, expressed an unqualified membership services25% annual conference 31%education program 17% journal 7% all other programs 20% amwa journal / v36 n1 / 2021 / amwa.org 53 a m w a news from $800,000 to $1,600,000. amwa’s unrestricted shortand long-term investment reserve level of $1,800,000 on june 30, 2020, was within this targeted range. amwa’s restricted endowment and mcgovern funds totaled $205,200 and $169,000, respectively. financial position an organization’s financial position is reflected in its asset and liability holdings. amwa is well positioned to pay its obligations and plan for the future. total assets were $3,160,138 as of june 30, 2020, and the organization’s liabilities totaled $561,680. financial statement audit results abercrombie and associates, amwa’s independent auditors, expressed an unqualified opinion regarding their audit of the financial statements for the fiscal year that ended june 30, 2020. an unqualified opinion states that the financial statements present fairly, in all material respects, an entity's financial position, results of operations, and cash flows in conformity with generally accepted accounting principles. amwa continues to be in a secure financial position as it continues expanding member benefits and resources into the next fiscal year. the full audit report is available to amwa members upon request. acknowledgment thanks to calibre cpa group, pllc, for providing the financial data and the members of the 2019-2020 budget and finance committee for their review of reports and budgets: june baldwin, adriana caballero, alice pappas, leena patel, whitney smalley-freed and christine wogan, ann winter-vann (201920 amwa president), gail v. flores (amwa president-elect), and susan krug (amwa executive director). author contact: julie@biomedisysinc.com organizational donors ($800) gail v. flores perfectit individual donors ($80+) lori l. alexander saleh alqahtani jack aslanian brian bass bookworm editing services llc nicole cooper tracy craig elise eller kathryn emily r. michelle sauer gehring heather gorby douglas haneline jessica kiser laurie kozbelt susan krug cynthia kryder sheryl lallemand eleanor mayfield donna miceli jennifer minarcik marcello morgan margaret norris julie phelan john redue jessica reimer stephanie vargas ann winter-vann 80th anniversary donors 80th anniversary donors generously support amwa’s 80 years educating medical communicators. tax-deductible donations help amwa fulfill its mission to promote excellence in medical communication and provide education and resources in support of that goal. � to make a donation, please visit www.amwa.org/donations mailto:julie@biomedisysinc.com http://www.amwa.org/donations amwa journal / v36 n2 / 2021 / amwa.org 63 23. icmje. recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals. icmje. 2019. accessed september 21, 2020. http://www.icmje.org/ recommendations 24. matcham j, julious s, pyke s, et al. proposed best practice for statisticians in the reporting and publication of pharmaceutical industry-sponsored clinical trials. pharm stat. 10(1):70-73. doi:10.1002/pst.417 25. ethical guidelines for peer reviewers (english) | cope: committee on publication ethics. doi:10.24318/cope.2019.1.9 26. the editors of the lancet group. learning from a retraction. lancet. 2020;396(10257):1056. doi:10.1016/s0140-6736(20)31958-9 27. jacobs a. adherence to the consort guideline in papers written by professional medical writers. med writ. 2010;19(3):196-200. 28. gattrell wt, hopewell s, young k, et al. professional medical writing support and the quality of randomised controlled trial reporting: a cross-sectional study. bmj open. 2016;6(2):e010329. doi:10.1136/bmjopen-2015-010329 29. bailey m. science editing and its effect on manuscript acceptance time. j am med writ assoc. 2011;26:147-152. 30. hamilton cw, gertel a, jacobs a, marchington j, weaver s, woolley k. mythbusting medical writing: goodbye ghosts, hello help. account res. 2016;23(3):178-194. doi:10.1080/08989621. 2015.1088788 31. woolley kl, ely ja, woolley mj, et al. declaration of medical writing assistance in international, peer-reviewed publications and effect of pharmaceutical sponsorship. fifth int congr peer rev biomed publ chicago. 2006;296(8):932-934. doi:10.1001/ jama.296.8.932-b 32. breugelmans r, barron jp. the role of in-house medical communications centers in medical institutions in nonnative english-speaking countries. chest. 2008;134(4):883-885. doi:10.1378/chest.08-1068 33. manring mmm, panzo ja, mayerson jl. a framework for improving resident research participation and scholarly output. j surg educ. 2014;71(1):8-13. doi:10.1016/j.jsurg.2013.07.011 34. woolley kl, lew ra, stretton s, et al. lack of involvement of medical writers and the pharmaceutical industry in publications retracted for misconduct: a systematic, controlled, retrospective study. curr med res opin. 2011;27(6):1175-1182. doi:10.1185/0300 7995.2011.573546 35. chipperfield l, citrome l, clark j, et al. authors’ submission toolkit: a practical guide to getting your research published. curr med res opin. 2010;26(8):1967-1982. doi:10.1185/03007995. 2010.499344 36. the equator network | enhancing the quality and transparency of health research. accessed september 21, 2020. https://www. equator-network.org dia june 27 to july 1, 2021 virtual https://www.diaglobal.org/flagship/dia-2021 regulatory affairs professionals society september 12-15, 2021 virtual https://www.raps.org/regulatory-convergence national association of science writers october 8-11, 2021 boulder, colorado, and virtual https://www.nasw.org/events/sciencewriters2021 international society of managing and technical editors october 11-14, 2021 virtual https://www.ismte.org/page/conferences international conference on communication in healthcare october 17-20, 2021 virtual https://achonline.org/icch2021 american public health association october 24-27, 2021 denver, colorado, and virtual https://www.apha.org/events-and-meetings/annual amwa medical writing & communication conference october 27-29, 2021 virtual www.amwa.org/conference association of health care journalists october 28-31, 2021 austin, tx https://healthjournalism.org/calendar-details.php?id=2245 european medical writers association november 4-6, 2021 cascais, portugal https://www.emwa.org/conferences/future-conferences/ calendar of meetings please confirm with individual meeting hosts www.amwa.org/conference 2021 amwa medical writing & communication conference october 27-29, 2021 coming to a device near you trends and opportunities for medical communicators continued from page 61 contents v35 n1 spring 2020 36 20 amwa position statement amwa position statement on legislation that negatively affects the livelihood of freelance medical communicators 2019 conference coverage freelance forum: seasoned freelancers jam in san diego � brian bass, with commentary from melissa l. bogen, sherri bowen, lori de milto, cathryn d. evans, and ruwaida vakil swanberg award address: expanding horizons as a medical writer � david b. clemow walter c. alvarez award address: aware: the science and practice of presence � daniel j. siegel john p. mcgovern award address: reluctant advocacy � paul offit open session reports: • influence of leaders and servant leadership • effective mentoring of medical writers: principles and practice • how to check consistency and enforce your house style: using perfectit in regulatory submissions and publications • sharepoint to the rescue! using sharepoint as a tool to manage medical writing teams and client partnerships • augmenting medical writing with artificial intelligence and natural language generation • reporting drug metabolism in the age of precision medicine • you can find a diamond in the rough: medical writing opportunities in rare diseases • text recycling in scientific research writing: findings from the text recycling research project • using narratives to improve health literacy and communicator credibility • predatory publishing: update on the current environment 3 4 8 13 20 24 13 welcome to this special issue, highlighting some of the excellent content presented at the annual medical writing & communication conference in san diego . . . and more! contents editor james r. cozzarin, els, mwc managing editor jennifer workman section editors around the career block lauren mcmahon, pharmd media reviews tara ann cartwright, phd practical matters qing zhou, phd, els regulatory insights jennifer bridgers, ms, mwc science series paul c. dolber, phd social media jennifer minarcik, ms statistically speaking thomas m. schindler, phd everyday ethics julie ravo, ba, ma members matters melory johnson, vn regular contributors freelance forum brian bass, mwc melissa l. bogen, els sherri bowen, ma, els lori de milto, mj cathryn d. evans gail flores, phd debra gordon, ms phyllis minick ruwaida vakil, msc, editor in the service of good writing laurie endicott thomas, ma, els editor at large haifa kassis, md editor emeritus lori l. alexander, mtpw, els, mwc editor in memoriam ronald j. sanchez 2019–2020 president ann winter-vann, phd 2019–2020 board liaison/ at-large director michelle sauer gehring, phd 2019–2020 staff liaison shari rager, ms, cae executive director susan krug, ms, cae graphic designer amy boches, biographics editorial office: managingeditor@amwa.org. instructions for authors available at: www.amwa.org/journal. advertising: contact marketing@amwa.org or (240) 239-0940. all advertising is subject to acceptance by amwa and should be for products and services relevant to professional medical communicators. amwa is not responsible for the content of advertising and does not endorse any advertiser or its products or services. subscription: the amwa journal is published quarterly. subscription is included with amwa membership. nonmember subscriptions cost is $75 per year. contact: american medical writers association, 30 west gude drive, #525, rockville, md 20850-4347. phone: (240) 238-0940; fax: (301) 294-9006; email: amwa@amwa.org. the amwa journal is in the mla international bibliography and selectively indexed in the cumulative index to nursing and allied health literature (cinahl) print index and the cinahl database. the opinions expressed by authors contributing to the journal do not necessarily reflect the opinions of amwa or the institutions with which the authors are affiliated. the association accepts no responsibility for the opinions expressed by contributors to the journal. ©2020 american medical writers association. all rights reserved, worldwide. issn 1075-6361 amwa journal mission statement in support of the mission of the american medical writers association (amwa) and to advance the broader profession, the amwa journal publishes content that reflects the interests, concerns, and expertise of medical communicators. its purpose is to inform, inspire, and motivate medical communicators. m o r e v35 n1 / 2020 35 preview note from the amwa writing committee authors of the amwa-emwa-ismpp statement on predatory publishing � barbara c. good, mary kemper, and donna simcoe 36 feature survey says! the business and money of freelance medical communications � erik maclaren 41 calendar of meetings 42 regulatory insights communicating real-world evidence for regulatory purposes: the rigor checklist � mary rofael and aaron csicseri 47 amwa news from the president � ann winter-vann annual business meeting cover photos: epnac.com mailto:managingeditor@amwa.org http://www.amwa.org/journal mailto:marketing@amwa.org mailto:amwa@amwa.org http://www.epnac.com 72 amwa journal / v36 n2 / 2021 / amwa.org f e a t u r e science series abstract coronavirus disease 2019 (covid-19), caused by the severe acute respiratory syndrome coronavirus 2 (sars-cov-2), has far-reaching impacts on human health. first identified as a disease of the respiratory system, covid-19 also causes gastrointestinal, renal, neurological, and/or cardiovascular symptoms. this article elucidates biological relationships between covid19 and the cardiovascular system. it postulates molecular and physiological mechanisms behind covid-19–related cardiovascular ailments and examines intersections among the cardiovascular system, sars-cov-2, covid-19, and certain medications. new scientific information on covid-19 and the cardiovascular system accumulates weekly. in recognition of such rapidity, this paper offers a framework in which the reader will be able to place the growing and evolving field of knowledge. effects of severe acute respiratory syndrome coronavirus 2 infection on the cardiovascular system severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infects cells through an interaction between the virus’s spike (s) protein and angiotensin-converting enzyme (ace) 2 in host cells.1-5 within the cardiovascular system, ace2 is reportedly located on heart muscle cells,6-11 endothelial cells (ecs) that line the interior of blood vessels and regulate blood clotting and blood pressure,12,13 pericytes that surround and aid ecs,6-8 and arterial smooth muscle cells (smcs) that control vascular diameter and thereby blood pressure and flow.7,12,13 sars-cov-2 infection of these cells hinders their health-promoting work. cardiovascular health is also threatened when sars-cov-2 invades noncardiac areas and triggers immune responses. to fight the “intruder,” local white blood cells activate, recruit other white blood cells, and produce pro-inflammatory chemicals, which increases inflammation. interestingly, a source of these chemicals may be direct sars-cov-2 infection of macrophages—a type of white blood cell that expresses ace2.14 as the immune system battles the virus, the affected body organ may (temporarily) malfunction. these malfunctions and the pro-inflammatory chemicals released into the blood may elicit negative effects on blood vessels and the heart.15 cardiovascular conditions induced by these direct and indirect effects of sars-cov-2 infection include myocarditis (inflamed heart tissue), blood pressure irregularities, abnormal blood clot (thrombus) formation, hypoxia, arteriosclerotic heart disease (ashd), myocardial infarctions (mis; heart attacks), arrhythmias, and heart failure (figure 1).16-29 if left unchecked or if severe enough, these ailments could be fatal. myocarditis myocarditis compromises contractility of the heart muscle. as a result, the heart compensates in order to insure proper delivery of blood (and o2) to the body. compensation occurs by one of at least 2 methods: (1) thickening of the heart muscle layer (hypertrophy), and (2) heart rate elevation (tachycardia). both choices could progressively worsen the heart’s already precarious condition. blood pressure irregularities some patients with coronavirus disease 2019 (covid-19) present with hypertension.19 the causal link between this elevated blood pressure and sars-cov-2 may be ace2. besides being the binding target of sars-cov-2’s s protein, ace2 is part of the renin–angiotensin system (ras) pathway (figure 2). the ras pathway controls smc contraction and relaxation and thereby influences blood pressure. smc contraction narrows vessels’ diameter (vasoconstriction) and raises blood pressure. smc relaxation widens vessels’ diameter (vasodilation) and lowers blood pressure. smc contraction and relaxation are controlled by the ras pathway’s angiotensin ii and angiotensin (1-7), respectively. ace1 converts relatively inactive angiotensin i into angiotensin ii, a highly active vasoconstrictor. ace2 converts angiotensin ii into angiotensin (1-7), a vasodilator (figure 2).30 ace2 levels likely decline in sars-cov-2–infected jennifer l. busch, phd / associate professor of biology, wheaton college, wheaton, il intersections of severe acute respiratory syndrome coronavirus 2, coronavirus disease 2019, and the cardiovascular system amwa journal / v36 n2 / 2021 / amwa.org 73 figure 1. confirmed and plausible mechanisms by which severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection causes cardiovascular symptoms. several cell types and organs (indicated by the spiked star symbol) are reported targets for sars-cov-2 infection. some of these host cells are part of the cardiovascular system, macrophages may lie within or outside of the cardiovascular system, and other sites lie outside of the cardiovascular system. (the cardiovascular system is defined by the thin-dashed enclosure.) infections initiate a variety of cardiovascular symptoms (shaded boxes) that, if prolonged and severe enough, cause arrhythmias and heart failure (shaded boxes with thick outline). viral infection of other organs may also affect the cardiovascular system in ways not specified here. related schematics can be found in guzik et al17 and atri et al.16 ashd, arteriosclerotic heart disease. figure 2. the renin–angiotensin system (ras) pathway and sites of angiotensin-converting enzyme (ace) inhibitor (acei) and angiotensin receptor blocker (arb) inhibition. in the ras pathway, renin (produced by the kidneys) converts angiotensinogen (produced by the liver) into angiotensin i. angiotensin i is modified into angiotensin ii, an active vasoconstrictor, by ace1. ace2 (the target for sars-cov-2 infection) produces the vasodilator angiotensin (1-7) from angiotensin ii. the acei and arb high-blood-pressure medications work by preventing vasoconstriction. they inhibit ace1 and binding of angiotensin ii to its receptors, respectively. 74 amwa journal / v36 n2 / 2021 / amwa.org cells.31-33 without ace2, levels of angiotensin (1-7) would decrease, and angiotensin ii levels would likely increase. these events would tip the scales toward vasoconstriction and elevated blood pressure. this mechanistic explanation for hypertension, although plausible, needs to be strengthened with additional research. another explanation for hypertension development in patients with covid-19 lies in direct viral infection of ecs and perhaps pericytes. both of these cell types impact blood vessel diameter (figure 1).34-36 a deficit of vasodilation or a prevalence of vasoconstriction likely causes hypertension. some patients with covid-19 develop low blood pressure (hypotension) rather than high blood pressure.22 hypotension is a symptom of acute respiratory distress syndrome (ards),37 so it is likely the result of sars-cov-2 infection of lung cells. thrombi formation and hypoxia another blood-related condition found in some patients with covid-19 is the presence of thrombi.23-25 these abnormal blood clots form in arteries or veins. interference of arterial blood flow jeopardizes delivery of o2 and nutrients to areas downstream of the blockage, whereas impedance of blood flow through a vein may cause swelling in the body upstream of the clot. besides blood-flow alteration, thrombi pose an additional risk to patients: pieces may break off the clot, travel through the bloodstream, and lodge in another blood vessel. these traveling clots (emboli) endanger other organs. when an embolus in a large systemic artery flows to a narrower artery within an organ, it may get stuck, hinder blood flow, and deprive downstream organs—or areas within an organ—of o2. emboli in veins pose a significant risk to the lungs. such emboli could migrate through the right heart chambers, lodge in the lungs’ narrow arterial branches, and impede blood flow to the pulmonary capillaries. complications of pulmonary emboli include right ventricular hypertrophy, swelling (edema), and low o2 levels in the blood (hypoxia) (figure 1). right ventricular hypertrophy and edema are indirect effects of a pulmonary embolism. to force blood past the pulmonary embolism, the heart’s right ventricle hypertrophies in an attempt to strengthen its pumping power. at best, this adjustment is a temporary fix. persistence of the embolism increases blood pressure in the right side of heart, and by extension, in the body’s veins. this elevated vascular pressure induces edema. gravity causes the swelling to be most prominent in the lower limbs. such edema also occurs in the lungs. this fluid buildup impedes the diffusion of o2 from the lungs’ alveoli to the blood in the pulmonary capillaries. it also reduces alveolar ventilation (o2 entry into the alveoli), as fluid-filled sacs fail to remain open. diminished blood flow to alveoli on account of pulmonary emboli may also prevent the blood from picking up adequate o2. collectively, these emboli-initiated events cause hypoxia. two culprits induce thrombi formation: injured ecs and pro-inflammatory chemicals (figure 1). ecs may be damaged by direct sars-cov-2 infection.38 such damaged cells activate platelets and make them more “sticky”; thus, they adhere to the vessel wall and to each other. clotting factors in the blood set off a chain reaction that culminates in the modification of fibrinogen to fibrin. fibrin threads attach to the mass of platelets to form the clot. if ecs are undamaged, a clot may still form: pro-inflammatory chemicals may activate platelets and clotting factors (figure 1).39 ashd, mis, and arrhythmias thrombi may form in the coronary arteries of some patients with covid-19, a condition known as ashd.26-28 coronary arteries carry o2-rich blood to the heart tissue. such o2 helps fuel the heart’s vital blood-pumping actions. partial or complete blockage of these coronary vessels is life-threatening. whether through blocked delivery or through hypoxia, insufficient o2 causes heart muscle cells to malfunction and die. the likelihood of mis increases (figure 1). mis in a small number of patients with covid-19 have been reported.26-28 arrhythmias have also been reported in some patients with covid-19.16,18,29 in the general population, these altered heart rhythms are caused by ashd, mis, myocarditis, and heart hypertrophy. therefore, these cardiovascular conditions are the current “suspects” for reported arrhythmias in covid-19– related cases.16,18,29 heart failure persistence of these aforementioned cardiovascular problems gradually weakens the heart, compromises its pumping ability and effectiveness, and can lead to heart failure (figure 1). the heart becomes progressively more incapable of delivering o2 and nutrient-rich blood to the body. preexisting heart failure appears to increase the likelihood of death from the disease in patients with covid-19.40 preexisting hypertension, ashd, arrhythmias, mis, and heart failure seem to increase the severity of covid-19 symptoms in patients. amwa journal / v36 n2 / 2021 / amwa.org 75 medications and health (covid-19 and cardiovascular) risks covid-19 impacts the cardiovascular system, but the inverse may also be true. percentages of patients with covid-19 and cardiovascular conditions are not higher than the prevalence of these conditions in the general population.18-20,40-46 therefore, these cardiovascular illnesses do not appear to increase one’s risk of developing covid-19. however, preexisting hypertension,18-20,40,41 ashd,18,19,40,41 arrhythmias,19,20,41 mis,20 and heart failure19,20,41 seem to increase the severity of covid-19 symptoms in patients. this observation led scientists to examine whether certain cardiovascularly related medications alter patients’ risk of sars-cov-2 infection and/or covid-19 severity. (it is worth noting that classifications of “severity” vary among studies. distinctions include normal vs high protein [troponin] concentrations in the blood, nonsevere vs severe disease, nonhospitalized patients vs hospitalized patients, non–intensive care unit [icu] patients vs icu patients, and survivors vs nonsurvivors.17,29) ace inhibitors and angiotensin receptor blockers some antihypertensive medications are the focus of such research. many americans (13% to nearly 50%, depending on definitions and the data source) have hypertension.42,45,46 this percentage increases as one ages.45 to lower high blood pressure, physicians may prescribe ace inhibitors (aceis) and/or angiotensin receptor blockers (arbs). these medications minimize production of angiotensin ii and block angiotensin ii’s interaction with receptors, respectively (figure 2), thereby preventing the vasoconstriction that elevates blood pressure (figure 2). however, certain aceis and arbs likely increase levels and activity of ace2 throughout the body.47-49 because ace2 is the receptor for sars-cov-2 binding, it is important to ascertain whether aceis and arbs alter patients’ risk of contracting sars-cov-2 and/or developing covid-19. mackey et al50 provide regular updates on newly published research articles pertaining to this topic. articles sampled from this compilation show wide variability in the study design.44,50-54 differences include variations in comparison groups, ethnic groups, statistical analyses, sample sizes, dates of studies (before or after widespread covid-19 testing), lengths of time on aceis or arbs, attention levels paid to confounding health issues, and definitions of “severe covid-19.” some articles are retrospective observational studies. such studies are subjective to selection bias; for example, a cohort of hypertensive patients tested for covid-19 leaves out hypertensive patients who did not get tested because they were asymptomatic. identification of patients prescribed aceis or arbs also assumes that the patients take these medications as prescribed, which may not be the case. nevertheless, most studies come to the same conclusion: use of aceis or arbs does not increase one’s risk of sars-cov-2 infection or development of severe covid-19.55,56 currently, the centers for disease control and prevention (cdc) and other cardiovascular health organizations advise patients to continue their acei or arb prescriptions, unless advised otherwise by a physician.57,58 clinical trials concerning aceis, arbs, and covid-19 are ongoing.59 interestingly, the aceiand arb-induced increase in ace2 expression levels may be advantageous to patients.52,54 it may counteract virally induced reduction of ace2 levels and thereby preserve the production of angiotensin (1-7), which lowers elevated blood pressure, promotes structural health of blood vessels and ecs, protects against cardiac hypertrophy, and may enhance blood cell production.60,61 covid-19 treatments and cardiac health risks some medications—lopinavir/ritonavir, hydroxychloroquine (hcq), favipiravir, remdesivir, and tocilizumab—were originally developed for other uses but demonstrate various levels of efficacy in treating patients with covid-19. lopinavir/ritonavir and hcq reportedly disrupt sars-cov-2’s entry into host cells.62 favipiravir and remdesivir likely prevent the replication of the virus’s genome.62 tocilizumab reduces inflammation by limiting the effectiveness of pro-inflammatory chemicals.62 last year, a multinational study of more than 10,000 patients examined the effects of some of these drugs on the mortality of patients with covid-19.63 the tests using hcq (low doses) and lopinavir/ritonavir were halted prematurely, as no improvements were seen.64 currently, the national institutes of health (nih) recommends against their use as a treatment for covid-19.65,66 these drugs have been linked to cardiovascular side effects. lopinavir/ritonavir, hcq, favipiravir and remdesivir may cause arrhythmias.29,67-69 lopinavir/ritonavir may trigger mis.70 furthermore, lopinavir/ritonavir and tocilizumab may compromise the effectiveness of cardiovascular medications.29,71 these cardiovascular risks are inferred primarily from a small number of studies with a small number of subjects without covid-19. a more robust examination of these drugs’ cardiovascular effects in patients with covid-19 has begun in several clinical trials funded by the nih.29 conclusion approximately 1.5 years have passed since sars-cov-2 and covid-19 were identified.1,72,73 in this time, much scientific understanding of sars-cov-2 infection patterns and covid19 comorbidities has been acquired. improved treatment procedures enhance patients’ prognoses, and awareness of drug side effects likely reduces health complications. this article 76 amwa journal / v36 n2 / 2021 / amwa.org illuminates the landscape of sars-cov-2 and covid-19 in relationship with the cardiovascular system and provides a biological foundation to support readers as they engage with the burgeoning quantity of scientific studies on this topic. indeed, the necessity of continued research remains. some current information is conjecture, drawn from studies on the first severe acute respiratory syndrome coronavirus or in patients without covid-19. other knowledge is based on only a few small studies and needs stronger support. longitudinal studies are necessary to determine the long-term effects of sars-cov-2 and covid-19 on human health. regardless, the approval of effective sars-cov-2 vaccines,74,75 enhancements to patient care, and funded clinical trials provide hope for a future in which sars-cov-2 infection rates decline, patient mortality decreases, and life without social-distancing restrictions resumes. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: jennifer.busch@wheaton.edu references 1. zhou p, yang xl, wang xg, et al. a pneumonia outbreak associated with a new coronavirus of probable bat origin. nature. 2020;579(7798):270273. doi:10.1038/s41586-020-2012-7 2. shang j, ye g, shi k, et al. structural basis of receptor recognition by sars-cov-2. nature. 2020;581(7807):221-224. doi:10.1038/s41586-0202179-y 3. yan r, zhang y, li y, xia l, guo y, zhou q. structural basis for the recognition of sars-cov-2 by full-length human ace2. science. 2020;367(6485):1444-1448. doi:10.1126/science.abb2762 4. hoffmann m, kleine-weber h, schroeder s, et al. sars-cov-2 cell entry depends on ace2 and tmprss2 and is blocked by a clinically proven protease inhibitor. cell. 2020;181(2):271-280, e8. doi:10.1016/j. cell.2020.02.052 5. wang q, zhang y, wu l, et al. structural and functional basis of sarscov-2 entry by using human ace2. cell. 2020;181(4):894-904, e9. doi:10.1016/j.cell.2020.03.045 6. chen l, li x, chen m, feng y, xiong c. the ace2 expression in human heart indicates 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https://clinicaltrials.gov/ct2/results?cond= covid19&term=ace%2c+arb&type=&rslt=&recrs=a&recrs=f&recrs=d& age_v=&gndr=&intr=&titles=&outc=&spons=&lead=&id=&cntry=&state= &city=&dist=&locn=&rsub=&strd_s=&strd_e=&prcd_s=&prcd_e=&sfpd_ s=&sfpd_e=&rfpd_s=&rfpd_e=&lupd_s=&lupd_e=&sort= 60. santos ra. angiotensin-(1-7). hypertension. 2014;63(6):1138-1147. doi:10.1161/hypertensionaha.113.01274 61. iusuf d, henning rh, van gilst wh, roks ajm. angiotensin-(1–7): pharmacological properties and pharmacotherapeutic perspectives. eur j pharmacol. 2008;585(2-3):303-312. doi:10.1016/j.ejphar.2008.02.090 62. vijayvargiya p, garrigos ze, almeida nec, gurram pr, stevens rw, razonable rr. treatment considerations for covid-19. mayo clin proc. 2020; 95(7):1454-1466. 63. who solidarity trial consortium. repurposed antiviral drugs for covid-19—interim who solidarity trial results. n engl j med. 2021; 384(6):497-511. doi:10.1056/nejmoa2023184 64. who discontinues hydroxychloroquine and lopinavir/ritonavir 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https://newsroom.heart.org/news/patients-taking-ace-i-and-arbs-who-contract-covid-19-should-continue-treatment-unless-otherwise-advised-by-their-physician https://newsroom.heart.org/news/patients-taking-ace-i-and-arbs-who-contract-covid-19-should-continue-treatment-unless-otherwise-advised-by-their-physician https://clinicaltrials.gov/ct2/results?cond=covid19&term=ace%2c+arb&type=&rslt=&recrs=a&recrs=f&recrs=d&age_v=&gndr=&intr=&titles=&outc=&spons=&lead=&id=&cntry=&state=&city=&dist=&locn=&rsub=&strd_s=&strd_e=&prcd_s=&prcd_e=&sfpd_s=&sfpd_e=&rfpd_s=&rfpd_e=&lupd_s=&lupd_e=&sort= https://www.who.int/news/item/04-07-2020-who-discontinues-hydroxychloroquine-and-lopinavir-ritonavir-treatment-arms-for-covid-19 https://www.who.int/news/item/04-07-2020-who-discontinues-hydroxychloroquine-and-lopinavir-ritonavir-treatment-arms-for-covid-19 https://www.who.int/news/item/04-07-2020-who-discontinues-hydroxychloroquine-and-lopinavir-ritonavir-treatment-arms-for-covid-19 https://www.who.int/news/item/04-07-2020-who-discontinues-hydroxychloroquine-and-lopinavir-ritonavir-treatment-arms-for-covid-19 78 amwa journal / v36 n2 / 2021 / amwa.org 65. chloroquine or hydroxychloroquine with or without azithromycin. covid-19 treatment guidelines. published october 9, 2020. accessed october 31, 2020. https://www.covid19treatmentguidelines.nih.gov/ antiviral-therapy/chloroquine-or-hydroxychloroquine-with-or-withoutazithromycin/ 66. lopinavir/ritonavir and other hiv protease inhibitors. covid19 treatment guidelines. national institutes of health. published february 11, 2021. accessed april 7, 2021. https://www. covid19treatmentguidelines.nih.gov/antiviral-therapy/lopinavirritonavir-and-other-hiv-protease-inhibitors/ 67. naksuk n, lazar s, peeraphatdit tb. cardiac safety of off-label covid-19 drug therapy: a review and proposed monitoring protocol. eur heart j acute cardiovasc care. 2020;9(3):215-221. doi:10.1177/2048872620922784 68. hooks m, bart b, vardeny o, westanmo a, adabag s. effects of hydroxychloroquine treatment on qt interval. heart rhythm. 2020;17(11):1930-1935. doi:10.1016/j.hrthm.2020.06.029 69. costedoat-chalumeau n, hulot js, amoura z, et al. heart conduction disorders related to antimalarials toxicity: an analysis of electrocardiograms in 85 patients treated with hydroxychloroquine for connective tissue diseases. rheumatology. 2007;46(5):808-810. doi:10.1093/rheumatology/kel402 70. bavinger c, bendavid e, niehaus k, et al. risk of cardiovascular disease from antiretroviral therapy for hiv: a systematic review. landay a, ed. plos one. 2013;8(3):e59551. doi:10.1371/journal.pone.0059551 71. kaletra tablets and oral solution. abbvie. accessed january 9, 2021. https://www.rxabbvie.com/pdf/kaletratabpi.pdf 72. zhu n, zhang d, wang w, et al. a novel coronavirus from patients with pneumonia in china, 2019. n engl j med. 2020;382(8):727-733. doi:10.1056/nejmoa2001017 73. naming the coronavirus disease (covid-19) and the virus that 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https://www.covid19treatmentguidelines.nih.gov/antiviral-therapy/chloroquine-or-hydroxychloroquine-with-or-without-azithromycin/ https://www.covid19treatmentguidelines.nih.gov/antiviral-therapy/lopinavir-ritonavir-and-other-hiv-protease-inhibitors/ https://www.rxabbvie.com/pdf/kaletratabpi.pdf https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/naming-the-coronavirus-diseasehttps://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/naming-the-coronavirus-diseasehttps://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/naming-the-coronavirus-disease-(covid-2019)-and-the-virus-that-causes-it https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/moderna-covid-19-vaccine http://www.amwa.org/es_express v37 n1 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 60 what an exciting time for the american medical writers association (amwa) as we make the 2022 spring issue of the amwa journal accessible on the new digital platform! my sincere appreciation goes to the amwa journal editorial team, amwa staff, and the volunteers who put in countless hours to help deliver such an outstanding publication. congratulations on your efforts in helping the organization to continue to evolve. as i think about volunteers and how they impact organizations like amwa, i can’t help but reflect on my own trajectory as a volunteer. looking back on my life experiences, i’ve always had the desire to help others and to do good. over the years i’ve volunteered for causes i was passionate about: children, education, health advocacy, communication, and so much more. as i grew in my field and more career opportunities became available, amwa seemed like the perfect fit to hone my leadership skills. it wasn’t long after i started dedicating time at the chapter level that i recognized this to be true. my passion grew, and i knew that i needed to do my part in “promoting excellence in medical communication,” and contributing to the development of educational resources. i soon began serving in various capacities throughout the organization, recruiting members to amwa, and encouraging others to volunteer within the organization. the more i served, the more my leadership skills grew. one key takeaway that has resonated with me over the years, is that leadership and volunteerism are connected. many people develop leadership skills through volunteering, and good leaders recognize the value of volunteers. from the president building leaders one volunteer at a time amwa news katrina r. burton, bs / 2021–2022 amwa president amwa’s governance structure highlights the strategic alignment of amwa volunteers and staff. president chapter advisory committee chair at-large directors treasurer immediate past president president-elect secretary special committees, councils, commissions, task forces, and work groups deputy director staff chapter officers chapter advisory committee nominating committee constitution and bylaws committee budget and finance committee overview of amwa governance structure chairs line of communication key executive director officers amwa board of directors http://www.amwajournal.org amwajournal.org 61building leaders one volunteer at a time according to a 2016 study surveying the impact that volunteerism has on the success of individuals in the workplace, 80% of hiring managers and those who have influence over hiring managers, indicated that those with volunteer experience move more easily into leadership roles. for the past 2 years, amwa, similarly to other organizations and associations, had to pivot to ensure we continued to deliver on our mission, vision, and priorities. we held virtual conferences in 2020 and 2021, continued to provide excellent educational resources, supported chapters and the important work generated by our committees throughout the pandemic, and grew our membership. this would not have been possible without the positive and hard work of our volunteers. volunteers help deliver vital programs and services while supporting the overall functionality of the organization. amwa volunteers are the heart and soul of this organization, and we are always looking for great leaders to grow with amwa. i know you recognize the value that you bring to the field as a medical communicator. i also hope that you understand what you can bring to the organization as a volunteer. the chapter level is a great place to break ground and help build your leadership skills. it also can be a pathway to leadership at the national level. whatever you do outside of your busy and productive schedules, i hope that you will consider becoming an amwa volunteer. after all, we are meant to leave organizations such as amwa better off than how we found them. ➲ if you are interested in becoming an amwa volunteer, please contact your local chapter or the amwa membership team at membership@amwa.org. www.amwa.org/knowledge_builders knowledge builders build your knowledge on a specific medical communication topic through a variety of elements designed to create an engaging educational experience. listen to a narrated slide set engage in exercises access the handout review the reading list note what you learned explore amwa online learning and get ready to l.e.a.r.n. http://www.amwajournal.org think you have what it takes to join a world-leading team of medical writers? we’d love to speak with you. become a medical writing ninja visit us at www.trilogywriting.com writers@trilogywriting.com www.trilogywriting.com/trilotalk listen to our podcast available on apple podcasts, google podcasts, and spotify amwajournal.org 60think like an editor: improving document quality for regulatory submissions • canada – health canada medical device incidents and health canada recalls and safety alerts databases • united kingdom – medicines and healthcare products regulatory agency (mhra) database • germany – federal institute for drugs and medical devices (bfarm) field corrective actions and bfarm recommendations databases • switzerland – swissmedic field safety and corrective actions (fsca) and swissmedic recalls databases • australia – tga device adverse even notification (daen) and tga system for australian recall actions (sara) databases other resources other helpful resources include sscps, which provide publicly accessible, up-to-date summaries of clinical data and other information about the safety and clinical performance of a medical device. sscp information can be accessed through https://ec.europa.eu/tools/eudamed/#/ screen/home. thi nguyen is a medical writer at icon plc based in fort lauderdale, fl. author contact: h.nguyen15@umiami.edu think like an editor: improving document quality for regulatory submissions speaker callie compton, ma / senior technical editor, certara synchrogenix, nashville, tn by paris karr, pharmd quality control (qc) is an integral part of ensuring accurate and consistent regulatory writing submissions. qc can be essentially defined as a process of checking consistency against a standard. however, in a writing context, qc is more specific than just “review.” considering different types of reviews (data, subject matter expert [sme], and editorial), the omission of each kind can have different implications. data and sme reviews can be critical for regulatory submissions, whereas an editorial review is often necessary for document appearance. in her presentation at amwa’s 2022 southeast regional conference, callie compton, senior technical editor at certara synchrogenix, identified common issues in the qc process and discussed strategies for regulatory medical writers to ensure a successful qc process. common issues compton began by outlining several examples of document inconsistency. such instances can include (but are not limited to) a document not aligning with sources, inconsistent terminology and style conventions, and errors in grammar, punctuation, and/or spelling. furthermore, she also identified issues that may arise downstream in the qc process, such as inadequate time allotted for qc, vague, unclear expectations and/or instructions, and misplaced expectations for role/review type. document consistency compton suggested that identifying specific standards that govern the document is a crucial step for qc. however, before the actual process of qc, regulatory medical writers should consider asking the following questions to ensure document consistency: • does my writing align with its source(s)? • is my writing easy to navigate? • do i write about the same content in the same way? • do the same components in my writing look the same? regulatory writing may often require checking external sources such as a tables, listings, and figures document or a clinical study report. to ensure that the writing is aligned with external content, it is important to clearly identify sources in the document and to keep them organized. compton illustrated that source references should specify document identifiers, such as the study identification, version number, or date, if applicable. consistent terminology and style conventions are also critical for regulatory documents. compton pointed out that a style guide can be an important tool to help maintain uniformity when there can be many acceptable writing conventions. a style guide may specify, for instance, • use of company/drug name • preferred template/toolbar • abbreviations/terminology, and/or • usage (eg, patient vs subject). compton elaborated that “style” may refer to 2 different things: writing composition or formatting. in discussing the latter, a qc checklist can help guide the medical writer to consistently perform specific assessments, line edits, and spelling checks as a process. qc process given its deadline-oriented and collaborative aspects, regulatory writing requires effective time management. compton pointed out that inadequate time allotments for qc during development stages or at the end of a project can lead to considerable quality risk. for that reason, the start of http://www.amwajournal.org https://ec.europa.eu/tools/eudamed/#/screen/home https://ec.europa.eu/tools/eudamed/#/screen/home amwajournal.org 61think like an editor: improving document quality for regulatory submissions the project is a crucial time to accurately estimate or prioritize time for qc. a writer should consider variables such as the types of checks needed (internal vs external), the deliverable’s page count, and document type. for instance, a 200-page original protocol developed with multiple reviews involving an external sme may require considerably more adjudication time than a protocol amendment that only clarifies the study’s exclusion criterion. compton also recommended that writers think about overall timeline, analyze the complexity of content, and quantify available resources. vague expectations and/or unclear instructions can also be a common pitfall in the qc process. from her editing experience, compton suggested that writers be proactive in communicating basic qc info. ideally, the type of review, specific sections (if only parts of the document need qc), file name/location, and deliverable due date/time should be clearly specified. writers help delineate various roles and expectations in the qc process. to illustrate, a sme should provide review as a content expert, not editorial aspects. compton emphasized the benefit of clearly establishing defined tasks between a writer (document author) and other collaborators. think like an editor regulatory medical writers can efficiently produce high-quality documents by applying consistency with tools and employing a clear starting plan with concrete communication. moreover, continuing to ask for qc feedback and learning from best practices will only empower writers to gain crucial perspective on the qc process. paris karr is a medical writer at ethis in winter park, fl. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: paris@ethisinc.com keep your amwa member profile up to date. help us understand more about you! what best describes your role as a medical writer? how would you describe your primary workplace/client? what is your primary professional area of focus? what are your additional professional areas of focus? what is your primary responsibility in your work? where do you live (city, state, country)? what is the highest level of education completed? what credentials or degrees do you have? which gender do you identify with? what is your race/ethnicity? what is your year of birth? log into www.amwa.org and update your profile today. http://www.amwajournal.org v37 n4 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 37 q1: how can i prepare my freelance business for the recession? although recessions are a natural part of the business cycle, it’s still scary to be freelancing during one. this recession may have more impact on freelancers than past recessions because more people began freelancing during the covid19 pandemic, and we’re living with staggering inflation. we’re facing increased competition for freelance work, and most of us can’t afford to make less money if our clients stop or reduce their use of freelancers. fortunately, health care is more stable than most industries in a recession, so freelance medical writers and editors will see less impact than freelancers in other industries. but even freelance medical writers and editors need to develop the right mindset and take the right actions to thrive in the recession. what you think—your mindset—is just as important in what happens to your freelance business during a recession as what you do. thriving takes a growth mindset, grit, and resilience. if you have a growth mindset, you believe that you can change your freelance future by learning new things, being persistent, and taking the right actions. you’ll be willing to work hard to reach your goals. grit is having the perseverance and passion to stick with your long-term goals until you reach them. resilience is the ability to meet adversity head-on, adapt, bounce back, and keep trying. research shows that we can all develop a growth mindset and build grit and resilience. next, you need a linkedin profile and website that focus on the needs of your target clients and how you meet their needs. your linkedin profile headline and about section must clearly say what you do, how you help your clients, and use the keywords your clients use when they search for freelancers. also, your profile needs to be complete. your website needs content that’s compelling, clear, and focused on client needs and a design that’s visually engaging, clear, fast loading, and easy to navigate. because there’s more competition for freelance work, you need to do more active marketing, especially networking through amwa and other professional associations. on linkedin, you need to be active enough to rank high when clients search for freelancers. — lori de milto i’m implementing 3 strategies to protect my business for this recession. all 3 strategies are actually general rules for my business. however, like most freelancers, during busy periods or times when i need to focus more energy on other areas of my life, i sometimes let my rules for successfully running my business slide. a recession is a great time to step back, assess, and reestablish practices to strengthen my business. the strategies are 1. increase cash flow. cash flow can be increased by earning more money and spending less money. earning more may be challenging in the current environment, aside from rate increases dictated by inflation (see my answer to question 2). i plan to spend less money by comparison shopping for business travel and office supplies (and using coupons and sales where possible), and by being smarter about meal expenses to my business. however, i feel it’s critical to maintain my membership in professional organizations, attend conferences, and invest in professional development opportunities to keep my business strong, so i will not be cutting back in those areas. 2. keep my current clients. to keep my favorite clients, i plan to ensure i continue to deliver my best work, return emails promptly, and let them know how much i appreciate them. 3. find new clients. at the same time, every good freelancer knows that relying on just a few clients can be risky. my client list shrank during the past 2 pandemic years; now, i plan to diversify and consider new clients. — gail v. flores * * * freelance focus brian bass gail v. floreslori de milto http://www.amwajournal.org amwajournal.org 38freelance focus q2: did you freeze or increase your pricing/rates at the beginning of the pandemic? if you did, are you making any further changes to those rates now? yes, i froze my rates during the covid-19 pandemic and recession. i’m doing the same now during this recession. this shows my clients that i understand how the recession impacts them, and that i am a team player. — lori de milto i did not change my rates when the pandemic came upon us because i have always offered a kind of “sliding scale,” so to speak, depending on the types of clients and their resources. for instance, i charge a certain hourly rate when i work directly with pharmaceutical/biotech companies, and a slightly decreased rate for contract research organizations and other agencies representing such companies—this, so that the agency will be able to mark up my rate and realize a profit. because i feel profit is essential for agencies like these, it seems fair to modify my hourly rate for them, that is, i will reduce my rate by 20%–25% for medical writing, editorial review/critique, editing, or quality assurance/quality control. however, if a client does not have a competent project manager and requires me to fill that role, i increase my rate by 25%–50% for that function. likewise, for nonprofit companies, i offer a reduced rate for writing grant proposals, patient education materials, website copy, standard operating procedures, and other documents—but if they ask me to develop and write their operational plan, (essentially, to think out and write their entire business plan) then my rate is increased by a minimum of 150%. as of 2022, i have increased my base hourly rate by 10% for all types of clients. so far, no push-back. — cathryn d. evans i charge by the project and don’t ever consciously increase or decrease my rates. i strive to always make the most money i can while delivering a product and a partnership experience for my clients that makes them say, “wow, let’s do this again!” at the start of the covid-19 pandemic, i enjoyed about 2 weeks of quiet because clients were fumbling to figure out how to work from home. it was wonderful. i was able to work without constant interruption and caught up on paperwork and organizing my office. but things didn’t stay peaceful for long. by the end of the first month, it seemed everyone had gotten to work at home. unfortunately, it quickly became clear they didn’t know how to get home from work. my workload exploded like never before, and it hasn’t really calmed down since. i’m not complaining! from a pricing standpoint, i’m still taking the same approach—charging as much as i can and doing everything possible to make sure my clients are happy because they’ve gotten a great value. but i have had to adjust my estimating to include a lot more phone and videoconference time, and that does affect my pricing. these days i find myself roped into everyone’s weekly status calls “just in case” someone mentions content, plus all the project-specific calls. i compensate for that time, of course, but i’d much rather have my fingers on the keyboard being productive. i think clients so miss interacting with their colleagues every day at the office that they’re compensating by inviting everyone to these calls and having as many calls as they can. — brian bass i did not freeze my rates when the pandemic started. during the 2007–2008 financial crisis, i froze my rates because i wanted to be “nice” to my clients. looking back, i wish i hadn’t because by doing so, i decreased my value. i saw something online recently that spelled it out really well: if you don’t increase your rates to at least match inflation, you are actually reducing your rates. therefore, i’ll continue to raise my rates in alignment with inflation and my increased value because of experience. however, i can still help my clients during these volatile financial times by noting inefficiencies and suggesting ways for them to streamline processes and to assign less specialized tasks to junior writers. — gail v. flores * * * q3: how do you handle payments from international clients? is there an optimal payment method that has worked for you? generally, i am very cautious about accepting work from a client outside the united states unless the company has been referred to me by another client or colleague i trust completely. essentially, the referring person must have worked for the international client and can assure me that this client pays every invoice within 30 days of billing. otherwise, i ask for $5,000 up-front, deposited into my account before i will begin working; thereafter, when i have used up the first $5,000, i ask for an additional advance and then work against that. because we have little recourse to collect from an international client, it is prudent to receive an advance before putting in time. if it is a small project, one can adjust the amount of the advance requested. http://www.amwajournal.org amwajournal.org 39freelance focus recently it was brought to my attention that the us government has embargoed certain countries—that is, that us citizens should not work for companies/clients within these countries—and that us banks are not allowed to accept money/deposits from such countries. so far, i have been unable to verify this properly, but amwa’s managing editor, rachel mosher, provided two links to websites that may be useful in researching this topic further (rachel mosher, ma, e-mail communication, 5 august 2022). from rachel: “the following information is provided by the office of foreign assets control within the us department of the treasury. this link details the countries that are currently sanctioned by the united states: https://home.treasury. gov/policy-issues/financial-sanctions/sanctions-programsand-country-information. the complete list of sanctioned individuals and businesses that us nationals should avoid doing business with can be found here: https://home. treasury.gov/policy-issues/financial-sanctions/speciallydesignated-nationals-and-blocked-persons-list-sdnhuman-readable-lists.” additionally, i contacted my banker in person to inquire about this. she said that the tellers may not accept in-person deposits of checks from iraq. she was not certain about direct deposits from that country. i strongly suggest that anyone, before accepting assignments being paid by a company in iraq (or other countries on the sanctions list provided above), telephone or meet with your own banker, who should be able to identify any countries from which the bank declines to accept deposits, whether they be electronic or in person. — cathryn d. evans i’ve had the pleasure of working with a number of clients over the years that are outside the united states, and i’ve found that the financial arrangement varies with each one. some have offices in the united states or us headquarters and issue checks or electronic payments in us dollars from those locations. that’s the easiest way to work. clients with only locations outside the united states have always sent payments electronically as automated clearing house transactions. i love it when my united states-based clients pay electronically, too. nothing says, “you’ve got mail,” quite like an email from the bank that says, “you’ve got money!” in my opinion, the most important financial consideration when working with clients based outside the country happens when i submit my estimate. this is where i stipulate that the estimate is in us dollars and that payment, if issued in another currency, must be equivalent to the invoiced amount in us dollars at the time payment is made. this way, i don’t have to worry about the exchange rate at the time of payment or about being paid less than the agreed and expected amount because of the exchange rate. there is the matter of currency exchange fees if the exchange happens at my bank (the receiving bank) rather than at the client’s bank (the sending bank). i don’t concern myself with this cost for 2 reasons: first, it happens so infrequently; and second, i charge by the project rather than by the hour so i’m charging for value instead of time, and there’s almost always enough money in the job to cover the relatively nominal cost for currency exchange. i’m careful about the companies with whom i work, especially when they’re based outside the united states, and particularly if they have no presence in the united states. it makes good sense to always choose your clients wisely, and even more so when you have to worry about straddling oceans, governments, languages, and currencies. — brian bass http://www.amwajournal.org https://home.treasury.gov/policy-issues/financial-sanctions/sanctions-programs-and-country-information https://home.treasury.gov/policy-issues/financial-sanctions/sanctions-programs-and-country-information https://home.treasury.gov/policy-issues/financial-sanctions/sanctions-programs-and-country-information https://home.treasury.gov/policy-issues/financial-sanctions/specially-designated-nationals-and-blocked-persons-list-sdn-human-readable-lists https://home.treasury.gov/policy-issues/financial-sanctions/specially-designated-nationals-and-blocked-persons-list-sdn-human-readable-lists https://home.treasury.gov/policy-issues/financial-sanctions/specially-designated-nationals-and-blocked-persons-list-sdn-human-readable-lists https://home.treasury.gov/policy-issues/financial-sanctions/specially-designated-nationals-and-blocked-persons-list-sdn-human-readable-lists v38 n1 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 20 laurie larusso, ms, els chestnut medical communications, walpole, ma by jerm day-storms, phd, mwc successful medical writers can clearly communicate a message to the intended audience. many times, the written word alone may not be the most effective method of communication. the client may even ask the medical writer for help in designing a visual aid or presentation. graphic design tools are available, but they may be cost-prohibitive or have steep learning curves for mastery. instead, medical writers can use a familiar tool, microsoft powerpoint, for graphic design. what is graphic design? graphic design is the art of visual communication using text, images, and symbols. medical writers use the 3 aspects of graphic design—layout, color, and typography— to help convey the message of the project. the layout consists of how the information is organized as well as how visual elements are placed on the page or slide. the colors and typography used can enhance the visual appeal of the work. graphics work by medical writers can be diverse. medical writers may be asked to format, lay out, or design slides or posters for presentations. they may create specific visual elements, such as charts, graphs, or diagrams. typically, a client provides a template and color palette, but a medical writer may be required to design a simple color palette and template. medical writers often transfer graphics from one format to another. for example, a single graphic element may be required to be transferred across manuscript, slide, and poster formats. when designing graphics, medical writers must • keep it simple by sticking to the main points, • remove superfluous information, • avoid an overwhelming number of objects and colors, and • use a logical order to make the story easy to understand. choosing the right tool for the job deciding which graphical element best explains the data is important. will the intended audience understand the story better if conveyed as a table, graph, diagram, or chart? sometimes, text is the best option if it is formatted to make it visually appealing, such as by varying color or font. other times, a medical writer may transform one less effective method into a better one for a particular point. for example, a table comparing 2 different treatments may be easier to understand as a graph. because medical writers must use graphics in a variety of projects, it is important to delve deeper into different types of graphics that can be produced using tools from the microsoft office suite. tables tables are the simplest graphical elements created by medical writers. for manuscripts, tables are created in microsoft word using the table function of the insert menu bar. likewise, for posters and slides, tables are created in powerpoint using the table function. tables created within either word or powerpoint are easily transferred by copying and pasting as a table with reformatting, as necessary. tables never need to be recreated when information is moved from one format to another. when using tables as a visual element in a project, it is best practice to keep color formatting consistent. for example, in a presentation or poster, the control group should be presented in tables as one specific color and the experimental group(s) in another throughout the project to increase the visual appeal and flow. another option is to use different background shades (from the same color palette, of course) for the control and experimental groups. tables can also be used to make text easier to read. data from bulleted lists can be transformed into a table with horizontal lines and light background, creating a visual element that is more scannable. similarly, tables can be used to simplify potentially complex topics by using different shades and/or symbols to help classify groups of data (figure 1). session report diy graphics for medical writers conference http://www.amwajournal.org amwajournal.org 21diy graphics for medical writers figures powerpoint offers built-in excel functionality, including the ability to create visually appealing charts and diagrams. for figures that are data-driven, such as graphs and charts, the data are stored within the embedded spreadsheet. the data can be easily updated in the spreadsheet with the changes automatically reflected in the slide’s graph. also, the graph can be reformatted within the slide. figures created within one presentation can easily be copied across different platforms, including manuscripts using word or posters using powerpoint. when copying a figure from a slide into a manuscript, it is best to paste the figure as a picture to lock in the formatting. when copying the figure into a different powerpoint file, do not paste the figure as a picture. from the paste options menu, choose “keep source formatting & embed workbook” for datadriven graphs. for any figures that are not data-driven, choose either “keep source formatting” to keep the graph formatting the same as in the original file or “use destination theme” if the desire is to have the format match the new file. resizing figures can be simplified by using the sizing function for uniform resizing. locking the aspect ratio maintains the same proportions of the original objects. it also allows for resizing multiple figures to precisely the same size. available figure options include traditional bar graphs, scatter plots, line graphs, and pie charts. additionally, more complex biostatics charts, such as forest plots and box and whisker plots, can be created or modified to help explain data. labels can be added to the data even for select data points, if desired. background shades or use of shapes can help highlight important data. creative use of shapes, graphs, and gradients can be used to visually tell a story. for example, a pie chart with a subchart can further sub-divide data into groups (figure 2). this example is created using 2 pie charts connected by a trapezoid filled in with a gradient to indicate a faded zoom. slides powerpoint’s reputation for creating robust slide presentations is well-known and well-documented. generally, the basics of any slide presentation consist of template, color, and graphics. the client will usually provide the medical writer with a slide template containing the approved color palette and appropriate layouts. occasionally, the medical writer may be tasked with developing a template which can be accomplished either by using or modifying one of the many theme templates from microsoft or by creating a template within the slide master menu of powerpoint. color can be used to organize information throughout the presentation to aid in the flow and to make it easier for the audience to understand. colors can be chosen from a list, gradient, or wheel, depending on the chosen menu. it may be difficult to precisely match 2 colors. each color has a unique six-digit hex code. if the hex code is known, it can be entered in to choose a color. however, if the hex code is unknown, the eyedropper tool can easily be used to select and match a desired color. this is helpful, for example, when trying to match legend colors to specific colors within a figure. slide presentations should be visually appealing, so graphical elements should comprise at least 2 out of every 3 slides. keep text at a minimum by converting as much text as possible to graphical elements. keep any bullet points to a single line of text, and do not use more than 2 levels of bullet points on a single slide. boring bullet point slides can be transformed into visually appealing graphical elements. for example, the bullets figure 1. the table as a visual element. tables can be used to create visual elements for classifying data by using shading and/or symbols. figure 2. complex figures to depict data. using graphs and charts with shapes and gradients can help tell the story of complex data. http://www.amwajournal.org amwajournal.org 22diy graphics for medical writers could be changed into vertical boxes with different shades of color to help each point stand out. rather than having a bulleted list of dates or events, a timeline figure can be created from the simple chevron shape in powerpoint. insert the chevron and stretch it out to create a timeline figure. the figure can even be filled in with a gradient of colors to help emphasize the passing of time or events. likewise, lines and icons can be added to the timeline. the color of icons can even be altered to match the timeline color. also, a simple bulleted list can be turned into an eye-grabbing visual aid with the addition of color and stock figures. for example, see how the following list is radically changed (figure 3). slide animations should be used sparingly. do not use animations as devices to transition from one slide to the next, such as the spinning slide, because it can distract from the presentation rather than enhance the story. only use animation to help the audience follow the story. for example, a build can be used to show progression or highlight important trends. if a graph, gel, or image contains large amounts of data, then an animation can be used to help the audience digest the information in smaller pieces. posters poster presentations can be created using powerpoint’s slide size menu function in which the poster is created on a single slide of the appropriate poster dimension. the poster layout, which plays a vital role in the presentation organization, may be either portrait or landscape. for portrait posters, the presentation is divided into horizontal sections whereas it is divided into vertical sections for landscape posters. regardless, the largest section of the poster organization should be reserved for the results. the title and authors are always listed across the top of the poster. additional poster sections include introduction/background, methods, and conclusions/summary. one way to economize space, if possible, is to move any acknowledgments, references, and disclosures to the bottom of the poster in a smaller font. posters should be saved as a pdf. like a slide presentation, color is an important aspect of the graphic design. use one main color with 2 accent colors chosen from the color palette. some graphs or figures that contain more data may require additional colors. the colors should be used consistently throughout the poster to maintain clarity and flow. poster content should primarily be visual elements with text at a minimum. the graphs, tables, and figures should be easy to understand without requiring extraneous textual details. section headings, such as background and results, should be one color with any subheadings in an accent color to help visualize hierarchy. medical writers do not need expensive tools for do-it-yourself graphics visually appealing, easy-to-follow graphical elements add clarity to a presentation or manuscript. medical writers can successfully create their own graphics without using expensive tools because microsoft powerpoint with its built-in excel function can create high-quality, editable visual elements. usually, clients are familiar with microsoft office figure 3. transforming bullets. simple bulleted lists (top) can be transformed into visually appealing graphical elements by using color and images (bottom). when creating graphics, remember to keep it simple so that the intended audience can follow the story and to not distract from the message by overloading with graphical elements or an overabundance of colors. http://www.amwajournal.org amwajournal.org 23diy graphics for medical writers products and are happy that the graphics can be easily transferred from one format to another. when creating graphics, remember to keep it simple so that the intended audience can follow the story and to not distract from the message by overloading with graphical elements or an overabundance of colors. by knowing which microsoft office product can be used to create the project and how to transfer it (figure 4), medical writers can design their own graphical elements or projects at lower cost and lower learning curve than an expensive graphics program when using a platform that most clients use. jerm day-storms is the owner and principal medical writer at day-storms medical writing & research, lakeland, fl. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: jerm@day-storms.com figure 4. do-it-yourself graphics for medical writers. medical writers can use inexpensive tools, such as microsoft powerpoint, to create, transfer, and present graphical elements. http://www.amwajournal.org v38 n3 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 33 credibility is integral to good science. and medical writers support the credibility of science with credible writing. they base their logic on previous findings, clearly describe the methods and results, and distinguish their interpretations from the data. in other words, they show the data and logic to strengthen credibility—and build trust with readers. but sometimes medical writers use vague language to describe their logic and interpretations. this vague language can undermine the content and tarnish the credibility of the work and the writing. although vague language can take many forms in medical writing, 3 phrases stand out as the most common phrases that tarnish credibility: “little is known,” “to our knowledge,” and “first to show.” little is known “little is known” is not a very convincing argument for a few reasons. first, most topics have had many papers published on them, so we likely know a lot about a particular topic. but medical writers are often writing about work that aimed (or aims) to answer an important question, fill a gap, or solve a problem. and that question, gap, or problem is bounded by what is known about the topic. “little is known” does a poor job of defining a specific question, gap, or problem. if you use this phrase, readers may think that you do not know the literature well or that you are overstating your case. second, “little is known” is often preceded or followed by more in-depth descriptions of what is known. these descriptions contradict the case for “little is known.” and these contradictions tarnish credibility. finally, “little is known” is not clear. a reader may wonder, “how little is little?” is there only one paper published on the topic? are there a dozen papers on the topic but none that answer the specific question that this work aimed to answer? is there an extensive body of literature on the topic, and the work aimed to confirm that a new tool will validate those findings? to craft a convincing argument, you need to define the specific question, gap, or problem that the work aimed (or aims) to fill. example avoid: little is known about how the drug reduces cell proliferation in lung cancer. preferred: although we know that the drug reduces proliferation of a549 cells, we do not know the mechanism by which the gene regulates this process. to our knowledge “to our knowledge” is also not a convincing statement. this statement implies that others may know certain information, but you may not be aware of it. by using “to our knowledge,” you may cast doubt in your reader’s mind about whether you really know the literature or field. what’s worse is that “to our knowledge” suggests that you do not want to be held accountable if that information becomes known. this lack of responsibility can damage your reputation and tarnish your credibility and the credibility of the work. to give readers confidence in the writing and the work, omit “to our knowledge” and only share known information. example avoid: to our knowledge, researchers have not uncovered how the drug reduces cell proliferation of lung cancer cells. preferred: although we do not fully understand how the drug reduces cell proliferation in lung cancer, researchers have linked the drug to cell mitosis in other cancer cells. first to show “first to show” may seem like a convincing statement. some writers believe that this phrase highlights the novelty or significance of the work and, therefore, is persuasive. but “first to show” suggests that you know everything in the field—published or unpublished. this conviction is difficult to guarantee. rather than persuade readers, “first to show” may lead readers to perceive that you are overconfident or overstating your case for novelty. crystal r. herron, phd, els / redwood ink, llc, san rafael, ca 3 common phrases that tarnish credibility in medical writing conscious writing http://www.amwajournal.org amwajournal.org 343 common phrases that tarnish credibility in medical writing unless you are indisputably certain that you are the first to show something, avoid using “first to show” in your writing. example avoid: we are the first to show that activation of the gene increases proliferation of a549 cells. preferred: we showed that activation of the gene increases proliferation of a549 cells. triple threat to credibility when used alone, these three phrases—“little is known,” “to our knowledge,” and “first to show”—can tarnish credibility. yet, writers often use all three phrases in the same document. they will try to build the case for the work with “little is known,” protect their reputation with “to our knowledge,” and claim the novelty or significance of the work with “first to show.” but when used together, these phrases can have a cumulative effect that erodes credibility in the writing and in the work. to support credibility, avoid using all three phrases— alone or together—in your writing. example avoid: little is known about how the drug affects plaque formation associated with alzheimer’s disease…. to our knowledge, this study is the first to show that the drug slows plaque formation, reducing the risk of alzheimer’s disease. preferred: although the drug reduces beta-amyloid, we do not know if the drug slows plaque formation associated with alzheimer’s disease…. in this study, we showed that the drug slows plaque formation, reducing the risk of alzheimer’s disease. make the credibility shine credibility is key to building and maintaining trust in science. and the phrases you use can strengthen or tarnish that credibility and trust. but with some mindfulness and intention to the phrases you use (or omit), you can polish your writing to ensure that the credibility shines. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest related this article. author contact: crystal.herron@redwoodink.com unlock the secrets to freelance success with this 3-part on-demand video series. gain relevant and practical advice from industry pros. run your business like a pro. • essential ingredients of a successful freelance business • bad behaviors that can sabotage your business • getting the clients you deserve unlock now in amwa online learning: www.amwa.org/freelance_success http://www.amwajournal.org v37 n2 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 25 shakespeare’s juliet asked, “what’s in a name? that which we call a rose / by any other name would smell as sweet.” (romeo and juliet act ii, scene ii, line 46-47) but juliet was a love-struck teenager. the chinese philosopher confucius gave advice that is more suitable for medical writers: “if names be not correct, language is not in accordance with the truth of things. if language be not in accordance with the truth of things, affairs cannot be conducted successfully.” (analects section 3, part 13) a diagnosis is a kind of name—a name that must be used accurately. real estate professionals tell us that the value of a property is determined by 3 factors: location, location, and location. likewise, the care that a patient receives will hinge on diagnosis, diagnosis, diagnosis. as medical writers, we need to understand what a diagnosis is, and what the process of diagnosis entails. when i am sick, i want my clinician (physician, nurse practitioner, or physician assistant) to give me 4 vital pieces of information: • what is wrong with me? (diagnosis) • why did this happen? (etiology) • what can be done about it? (therapeutics) • what will happen to me because of all this? (prognosis) sometimes, the answer to the first question will practically dictate the answers to the rest of the questions. if i receive a diagnosis of influenza, it means that my clinician thinks that my illness resulted from infection with an influenza virus. this diagnosis will affect how my illness will be treated and the predictions that will be made about what will happen to me next. what is a diagnosis? the word diagnosis came from ancient greek. diacame from a root that meant “through, in different directions, or between,” but could also mean “thoroughly,” and gnosis meant knowledge. so, the word diagnosis implied a form of knowledge that was chosen from among a set of possibilities. likewise, promeant “before,” so a prognosis meant foreknowledge—a prediction. many things can go wrong with the human body. a diagnosis implies that the clinician knows something about what has gone wrong in a particular case. a prognosis is the clinician’s educated guess of what will happen in the future. diagnosis is a noun, but it has been transformed into the verb to diagnose. thus, diagnosis can be viewed as a process, not just as the label that is applied to the patient’s illness at the completion of the process. differential diagnosis can mean the process of choosing from among 2 or more conditions that produce a similar clinical picture. however, a differential diagnosis can also mean the list of possible explanations for a patient’s condition. each item on the list is a diagnostic differential. the ancient greek philosopher plato suggested that knowledge is a justified true belief.1 a diagnosis is a belief that is (one hopes) justifiable. ideally, there would be some consensus within the scientific community and the medical profession about how each diagnosis can or should be justified. some diagnoses can be justified by some sort of pathognomonic sign or symptom (ie, something that is distinctively characteristic of that condition). others are justified by the result of imaging or a laboratory test. the justification could be a formal case definition—a set of criteria that must be met. yet even if a diagnosis seems to meet the appropriate criteria, it could still be wrong. medical students are taught heuristics for diagnosis. a heuristic is an approach to problem-solving. the word heuristic came from the greek verb heuriskein, which means to discover. one approach is to consider the most common conditions first—yet rare diseases do occur, albeit rarely. another approach is to try to find a single diagnosis that explains every aspect of the patient’s condition, because the simplest explanation is most likely to be correct. this is in line with the principle called occam’s razor: “entities should not be multiplied beyond necessity.” yet occam’s razor must be balanced against hickam’s dictum: “a patient can have as many diseases as he damn well pleases.” clinicians can make errors in diagnosis for countless reasons. however, those errors all fall into 2 basic categories: • a misdiagnosis means that the patient was given a diagnosis of a condition that he or she did not really have. a misdiagnosis is easy to make when several different laurie endicott thomas, ma, els / madison, nj what’s in a name? (diagnosis) in the service of good writing http://www.amwajournal.org amwajournal.org 26what’s in a name? (diagnosis) diseases produce similar signs and symptoms. a misdiagnosis can also result from a false-positive result from a diagnostic test. • a missed diagnosis (also known as a failure to diagnose) means that the clinician failed to provide the correct diagnosis. this problem can be due to a false-negative result from a diagnostic test. it can also result from a failure of imagination called premature closure of the differential: a failure to include the correct diagnosis among the differentials being considered.2 these individual errors can add up to a systematic underor overdiagnosis of a disorder. • underdiagnosis means that the condition is being missed in a significant proportion of cases. under-diagnosis is common when the population has poor access to medical care, when there is poor awareness of the condition among the population and/or the clinicians, or when the correct diagnosis is hard to make. • overdiagnosis means that too many patients are being given the diagnosis. the diagnosis is being given to patients who do not have the condition at all and/or it is being given to patients whose cases are too mild to warrant medical attention. overdiagnosis can be a result of disease mongering, which is the practice of inappropriately widening the diagnostic criteria for a medical condition and aggressively promoting public awareness, to expand the market for diagnostics and treatments. for the individual patient, an error in diagnosis can lead to bad treatment decisions and bad outcomes. on a societal level, these individual errors may result in poor public health and large-scale misallocation of resources. diagnoses are labels a diagnosis is a label that is applied to a patient’s illness. this labeling allows clinicians and scientists to sort cases of illness into categories and to sort patients into groups, which makes it possible to do clinical studies. some diagnostic labels imply the kind of knowledge that the clinician believes that he or she has about the patient’s condition. others refer to the process through which the clinician’s belief was justified (see types of diagnosis). types of diagnoses admitting diagnosis—the diagnosis reported by the clinician who decided that the patient needs to be hospitalized. the admitting diagnosis may be tentative because the patient has yet to undergo examinations and testing. the admitting diagnosis is recorded for administrative purposes. biologic diagnosis—a diagnosis based on a test performed on a laboratory animal (eg, inoculation of a cell culture, egg, or laboratory animal with a patient’s specimen to isolate a virus). clinical diagnosis—a diagnosis based on the patient’s symptoms and clinical signs at examination, as well as the patient’s history. symptoms are phenomena (eg, pain) that are subjective (ie, only the patient can observe them). clinical signs are phenomena (eg, swelling, heat, or redness) that are objective (ie, the examining clinician can observe them). the term clinical diagnosis can also mean a diagnosis that was based on all the information (including laboratory and imaging results) available during the patient’s lifetime, as compared with the autopsy findings. cytologic diagnosis—diagnosis based on examination of exfoliated (shed) cells. definitive diagnosis—a final diagnosis based on the results of confirmatory testing. diagnosis of exclusion—a diagnosis made by eliminating all of the other known differentials. diagnosis ex juvantibus—a diagnosis based on the result of treatment, such as antibiotic therapy. direct diagnosis—a diagnosis made by observing structural lesions or pathognomonic signs or symptoms. pathognomonic means distinctly characteristic of a particular disease. discharge diagnosis—the diagnosis recorded when the patient leaves the hospital. etiologic diagnosis—a diagnosis that implies the underlying cause of an illness (eg, a diagnosis of measles means that the clinician believes that the patient has a measles virus infection), or the process of identifying the underlying cause of the illness (eg, isolation of a particular strain of bacteria in the case of an infection). faux diagnosis—a false diagnosis that is made for some administrative purpose. laboratory diagnosis—a diagnosis based on the results of tests or examinations performed in a laboratory on specimens (eg, of tissue or bodily fluids) taken from the patient. niveau diagnosis—localization of the exact level (niveau in french) of a lesion, such as in the spinal cord. pathologic diagnosis—a diagnosis based on the observed presence of structural lesions. the clinicopathologic method meant comparing the records of the patient’s condition during lifetime with the autopsy findings. physical diagnosis—a diagnosis based on looking at (inspection), feeling (palpation), tapping on (percussion), and listening to (auscultation) the patient’s body. presumptive diagnosis—a diagnosis based on the known probability of a known condition, such as the antemortem diagnosis of a disorder that can be confirmed only at autopsy. (compare with definitive diagnosis.) provocative diagnosis—a diagnosis based on a provocative test, such as exposure to an allergen to confirm an allergy. radiologic diagnosis—a diagnosis based on the results of imaging, such as x-ray imaging, computed tomography, or magnetic resonance imaging. serum diagnosis—a diagnosis based on testing of serum (the fluid left after a blood sample coagulates). syndromic diagnosis—the recognition of a group of signs and symptoms that characterize a clinical condition that might not always result from the same cause. the word syndrome came from the greek for “occurring together.” if research shows that a particular syndrome always results from a particular cause, the syndrome becomes a disease. wastebasket diagnosis—a vague and possibly meaningless diagnosis given when a patient’s condition cannot be easily classified. working diagnosis—the differential (or set of differentials) that is considered most likely to be the true diagnosis. http://www.amwajournal.org amwajournal.org 27what’s in a name? (diagnosis) cause or effect? diagnoses are labels that allow us to sort cases. however, diagnostic labels themselves can be sorted into categories, such as etiologic (ie, pertaining to cause) vs syndromic (ie, pertaining to the pattern of observable effects). some diagnoses (eg, the classic exanthems) start off as a syndromic diagnosis, only to become an etiologic diagnosis as its cause is revealed. an exanthem is an acute, sudden illness that involves a widespread rash along with other symptoms (eg, fever and headache). by the early 10th century, the persian physician abū bakr muhammad ibn zakariyyā al-rāzī (known in the west as rhazes) knew that smallpox and measles were separate diseases. yet the causes of those 2 diseases remained unknown for another millennium. in the early 20th century, pediatricians assigned numbers to the most common childhood exanthems (box: the classic exanthems).3 these disorders began as clinical syndromes. but in the 20th century, researchers found that each of these classic exanthems (except for fourth disease, which might not exist as a separate entity) was due to a different infectious agent. thus, 5 out of the 6 classic exanthems became diseases, and the diagnoses changed from syndromic to etiologic diagnoses. names and numbers medical conditions often had 2 names: the popular name and the scientific name (eg, measles and rubeola). a medical condition was often named after the person who first described it in the medical literature (eg, cushing’s syndrome). today, ama style requires us to drop the ’s after the person’s name (cushing syndrome). sometimes, the name of a condition changes. for example, dementia praecox became schizophrenia, and manic-depression became bipolar disorder. sometimes, the name is changed because the cause is discovered (eg, “de vivo syndrome” became “glucose transporter type 1 deficiency syndrome”). in may 2015, the world health organization recommended that new diseases should not be named after persons or refer to geographical locations, animals, foods, cultural or occupational groups, or populations or industries and should not include terms that incite undue fear (eg, fatal).4 if you are uncertain of the current name of a condition, you might look it up under the medical subject headings thesaurus of the national library of medicine (https:// www.ncbi.nlm.nih.gov/mesh). genetic disorders are catalogued in online medical inheritance in man (https://www. omim.org/), a joint effort between the national library of medicine and johns hopkins university. to make it easier to record medical diagnoses and compile statistics on public health, the world health organization introduced the international classification of diseases and related health problems. the 11th edition, which is currently being implemented, provides roughly 55,000 unique alphanumeric codes for diseases, injuries, and causes of death. for example, the code for a distal fracture of right radius with dorsal tilt and joint involvement after falling on the sidewalk would be nc32.50 & xk9k & xj5gs / pa60 & xe53a.5 similarly, the american psychiatric association’s diagnostic and statistical manual, currently in its fifth revision (dsm-5), is used in the united states for coding mental disorders. binaries, scales, and spectrum diagnoses many common diagnoses involve some sort of binary. a binary is some variable that can have one of 2 values: on or off, yes or no, alive or dead, male or female, pregnant or not pregnant. yet in practice, even a yes-or-no question has 3 possible answers: yes, no, and no answer. although a binary involves 2 categories that are separate conceptually, the boundary between the 2 categories may be fuzzy in practice. thus, it can be hard to classify some individuals. for example, a child’s biological sex is a diagnosis that used to be made at birth but is now often made much earlier, during an ultrasound examination. nearly every human being can easily be classified as either male or female on the basis of their phenotype (their anatomy) or their karyotype (presence or absence of a y chromosome). nevertheless, there are a few cases (about 1 in 5,500 live births)6 in which a newborn’s external anatomy does not match the chromosomal sex or cannot be easily classified. these rare cases do not prove that sex is nonbinary. rather, they just illustrate that the boundary between the 2 categories is slightly fuzzy. even if the boundary between categories is a single clear criterion, some cases can be misclassified if the criterion is the classic exanthems in the early 20th century, pediatricians numbered the most common childhood exanthems (diseases that caused a rash and other symptoms, such as fever)3: • first disease was rubeola (measles) • second disease was scarlet fever • third disease was rubella (german measles) • fourth disease was duke’s disease (unknown today) • fifth disease (erythema infectiosum or slapped cheek syndrome) is still called fifth disease • sixth disease was roseola infantam. measles, rubella, fifth disease, and roseola are caused by viral infections. scarlet fever results from a bacterial infection (group a streptococcus). http://www.amwajournal.org https://www.ncbi.nlm.nih.gov/mesh https://www.ncbi.nlm.nih.gov/mesh https://www.omim.org/ https://www.omim.org/ amwajournal.org 28what’s in a name? (diagnosis) hard to document. for example, a woman is either pregnant or not pregnant. by definition, a pregnancy begins when an embryo implants itself on the inner lining of the uterus. yet the pregnancy cannot be detected by blood or urine tests until a few days after implantation. many diagnoses depend on some sort of measurement (body weight, blood pressure measurements, iq scores) that falls somewhere on a scale. this kind of diagnosis raises important questions: is the measurement accurate? is the scale meaningful? where should the lines between categories be drawn? consider the diagnosis of obesity. obesity means that the body contains too much fat. yet body fat content (adiposity) is rarely measured directly. instead, clinicians measure body weight (in kilograms) and divide it by the square of the height (in meters) to calculate the body mass index. body mass index provides a useful rule of thumb. however, bodybuilders can have a body mass index in the obese range despite having very little body fat. also, the body mass index tends to underestimate body fat in short people and overestimate it in tall people.7 yet even if you developed a better metric than body mass index, you would still have to decide where to draw the lines between the categories of underweight, normal weight, overweight, and obese. even if you draw those lines in reasonable places, someone whose weight falls close to the boundary between categories could switch from one to the other and back within the course of a single day. sometimes, differences in magnitude can seem to produce differences in kind. if a patient receives a different diagnosis than another patient received, the difference in labeling seems to imply that the 2 patients have different kinds of problem. yet the 2 patients might have the same underlying kind of problem but at different levels of severity. a spectrum disorder is a set of conditions that look different but are believed to represent the same underlying problem at different levels of severity,8 just as light at different wavelengths looks like different kinds of light. psychiatric diagnoses and the biopsychosocial model psychiatric diagnoses pose a particularly thorny set of problems. in general, a mental illness can be any problem that involves one or more of the following: cognition (perceptions and thoughts), emotion (feelings), or action (behavior). to be considered a mental disorder, a mental illness must cause distress or disability, must not be an expectable or culturally sanctioned response to a particular event, and must not be primarily a result of social deviance or conflict with society. unfortunately, these concepts are broad and lack precise boundaries. some mental disorders may have a purely biological cause. others seem to result from a combination of biological, psychological, and social causes. the biopsychosocial model accepts that all 3 kinds of causes can contribute and may be interrelated. psychiatry is part of medicine because many mental disorders are believed to have at least some basis in biology. yet once a particular condition is shown to have a clear biological basis (eg, psychosis due to anti-nmethyl-d-aspartate receptor encephalitis), that condition tends to get reclassified as a neurologic disease as opposed to a mental disorder. as a result, psychiatry is left with a set of conditions whose etiology is unknown or is so complicated that it might never be untangled. for this reason, psychiatric diagnoses are generally syndromic (ie, based on a pattern of signs and symptoms) as opposed to etiologic (ie, a statement of cause). thus, psychiatrists use diagnostic testing to rule out medical diagnoses, as opposed to confirming psychiatric diagnoses. when trying to figure out the cause of a mental disorder, some psychiatrists prefer to err on the side of biology whereas others prefer to err on the side of psychosocial causes. medical writers should be alert for either kind of bias. in particular, medical writers should be skeptical whenever a diagnostic label suggests that a patient’s physical symptoms are psychological in origin.9 conversely, medical writers should also be skeptical of the use of medical-sounding diagnoses for social or educational problems. in 1851, samuel a. cartwright argued that slaves who tried to escape from slavery were exhibiting a mental illness that he called drapetomania.10 today, children who have trouble with the “3 r’s” (reading, writing, and arithmetic) are routinely given the diagnoses of dyslexia, dysgraphia, and key points when writing about any diagnosis, think carefully about what that diagnostic label means. • is the diagnostician asserting something about the cause of the patient’s condition? or does the diagnosis simply mean that the signs and symptoms follow a familiar pattern? • how is that diagnosis justified? is it supported by physical examination findings, radiologic findings, or the results of laboratory testing? • how meaningful are the criteria for making the diagnosis, and how reliably are they being applied? • how severe must a case of a condition be to qualify for the diagnosis? how were the boundaries between normal and abnormal values determined? • is the diagnostic label saying something true about the patient? or is it sending a misleading message that undermines the patient’s interests? http://www.amwajournal.org amwajournal.org 29what’s in a name? (diagnosis) dyscalculia. this use of these medical terms implies that the cause of the problem is in the child’s brain, when the cause of the child’s poor academic performance could very well be in the child’s schooling (eg, bad methods for teaching reading and math and a refusal to teach penmanship). if we are using a medical label for a problem whose cause is pedagogical, not medical, then (to paraphrase confucius) our language is not in accordance with the truth of things, and our affairs cannot be conducted successfully. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: lthomas521@verizon.net references 1. plato. meno. jowett b, trans. accessed april 21, 2022. http:// classics.mit.edu/plato/meno.html 2. kumar b, kanna b, kumar s. the pitfalls of premature closure: clinical decision-making in a case of aortic dissection. case rep. 2011. https://doi.org/10.1136/bcr.08.2011.4594 3. shapiro l. the numbered diseases: first through sixth. jama. 1965;194(6):680. 4. world health organization. world health organization best practices for the naming of new human infectious diseases. world health organization website. published may 15, 2015. accessed april 21, 2022. https://www.who.int/publications/i/item/whohse-fos-15.1 5. harrison je, weber s, jakob r, chute cg. icd-11: an international classification of diseases for the twenty-first century. bmc med inform decis mak. 2021;21(suppl 6):206. 6. kim ks, kim j. disorders of sex development. korean j urol. 2012;53(1):1-8. 7. nuttall fq. body mass index: obesity, bmi, and health: a critical review. nutr today. 2015;50(3):117-128. 8. hodges h, fealko c, soares n. autism spectrum disorder: definition, epidemiology, causes, and clinical evaluation. transl pediatr. 2020;9(suppl 1):s55-s65. 9. thomas le. are your patient’s medically unexplained symptoms really “all in her head”? med hypotheses. 2012:78(4):542-547. 10. cartwright sa. report on the diseases and physical peculiarities of the negro race. n orleans med surg j. 1851;691-715. www.amwa.org/knowledge_builders knowledge builders build your knowledge on a specific medical communication topic through a variety of elements designed to create an engaging educational experience. listen to a narrated slide set engage in exercises access the handout review the reading list note what you learned explore amwa online learning and get ready to l.e.a.r.n. http://www.amwajournal.org http://classics.mit.edu/plato/meno.html http://classics.mit.edu/plato/meno.html https://doi.org/10.1136/bcr.08.2011.4594 https://www.who.int/publications/i/item/who-hse-fos-15.1 https://www.who.int/publications/i/item/who-hse-fos-15.1 v38 n2 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 51 speaker crystal r. herron, phd, els managing director, redwood ink, san rafael, ca by allie boman stories make your writing stronger and your message more engaging. dr crystal r. herron uses tools and mindsets rooted in scientific observation to make her case for storytelling as the backbone of an effective manuscript. stories tap into the power of curiosity— and love stories stimulate the production of love hormones. we feel good when we read, watch, or hear stories from others—the mechanism of this good feeling is greater levels of oxytocin. leveraging the power of storytelling at every level of our writing helps us to connect with readers, engaging them and helping them remember what we said. data are like lego building blocks, dr herron pointed out. raw data are like a pile of legos—it’s all there, but it’s a mess. we might sort these data by color so they’re a little easier to understand. then we might present the data in a logical way, organizing the stacks of color by height. now imagine those blocks rearranged into a lego house, complete with a colorful front door and bordered with flowers. a house with personality invites questions (who lives there? will a little lego guy walk out the front door soon?). storytelling generates curiosity. using the stacr structure to strengthen manuscripts although variations abound, engaging stories tend to follow a similar structure, abbreviated as stacr (which ties in well with the legos illustration!). dr herron explained this structure and how to use it to keep readers reading. she also gave examples for applying these ideas to a medical manuscript and mapping stacr onto the standard imrad (introduction, methods, results, and discussion) structure. s = setup • who are the characters in this story? (proteins, compounds, disease state, device) • where or in what setting does the story take place? (proteins within a particular cell, disease that affects a certain organ, patients in a hospital or outpatient location) • what problem(s) surround the characters? (prevalence of the disease, previous devices that proved insufficient, no drug available) t = tension • what do the characters need to accomplish? how can they solve the problem you set up? (disease progression needs to be slowed; gene mutation may change protein function) • what question do you answer in this story? (does this drug have fewer side effects than others available? does this device work better?) • how does this tension connect with the problem from your setup section? (making this connection helps to engage readers’ curiosity.) a = action • what happens to address the questions raised in the tension section? (what methods were used)? • how did the characters respond to a change in the setting? (what were the results?) c = climax • did the characters answer the question? (what were the key findings and how did they answer the questions posed?) • how will readers’ curiosity be satisfied? (refer to elements raised in the tension section.) r = resolution • how have the characters and setting changed as a result of the action? (how does this work advance the field?) • what value does this story offer? why does it matter? (what is the significance of the study?) writing a manuscript using stacr helps readers understand the importance of your work and use what they’ve read. session report the backbone of manuscripts: supporting your writing with storytelling conference http://www.amwajournal.org amwajournal.org 52supporting your writing with storytelling in addition to giving a brief history of the standard manuscript structure, dr herron explained that the imrad structure follows the stacr flow fairly naturally (see figure 1). micro-stories strengthen your writing from the inside out additionally, dr herron explained that the story structure can be applied to paragraphs and sentences. using this tool on nano and micro levels, in addition to the macro level, makes your entire document strong and dynamic, like a living organism with a backbone. at the nano (sentences) level, the story arc is compressed into setup, tension/action/climax, and resolution. basic sentences include a subject (introducing a character is the setup), verb (tension/action/climax), and object (resolution—satisfying curiosity by answering what happened to the character). dr herron gave the following example: • setup: “crystal” (what about crystal? we are curious) • tension/action/climax: “loves” (ah, this is a positive sentence) • resolution: “dogs” (satisfies our curiosity about what crystal loves) most of the sentences we write will be more complex than this, making it easier to create the setup, build tension, fill in the action, relieve tension with the climax, and resolve the nano-story. likewise, a great paragraph is made of micro-story arcs, arranged in an order that supports the overall story in the paper. developing this structure on a paragraph level helps you ensure that each paragraph has a coherent purpose within the overarching story of the manuscript. ultimately, a manuscript tells the story of work that may have taken years to accomplish. dr herron challenged audience members to use a story structure to build and strengthen their manuscripts, enabling them to engage readers while informing them—and thereby have greater influence in the field. for more on this topic, see “the intrinsic story structure of original research manuscripts,” by crystal r. herron, in the march 2023 issue of this journal (amwa j. 2023;38[1]). allie boman is lead editor at boman editing in highwood, il. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: allie@bomanediting.com figure 1. three-act story structure in original research manuscripts. a. three-act structure commonly found in stories. b. three-act story structure found in original research manuscripts that follow the standard imrad (introduction, methods, results, and discussion) structure. reprinted from "the intrinsic story structure of original research manuscripts,” by crystal r. herron, in the march 2023 issue of this journal (amwa j. 2023;38[1]). http://www.amwajournal.org https://doi.org/10.55752/amwa.2023.227 https://doi.org/10.55752/amwa.2023.227 cover v38 n2 contents mission statement, masthead from the guest editor theme article an overview of the 2022 update of gpp guidelines theme article gpp 2022 update: an interview with dikran toroser theme article a medical writer’s guide: working on clinical research manuscripts topical feature the business of medical writing: understanding the value topical feature effective onscreen editing: new tools for an old profession science series everyday ethics freelance focus ce craft corner continuing education writing: know your clinician audience ce craft corner practical strategies for creating cme/ce content: insights conference-session report: the backbone of manuscripts: supporting your writing with storytelling conference-session report: journalistic approach to writing better abstracts conference-session report: the new normal in the medical publications sector amwa news from the president 2022 annual business meeting for amwa amwa financial report, 2021-2022 amwa’s fourth medical writing executives forum medical writers apprentice programs survey results 2023 conference preview calendar of meetings v38 n2 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 53 speaker susan aiello, dvm, els words world consulting, townsend, tn by tonya scardina, pharmd dr aiello emphasized the importance of a well-written abstract. after the title, the abstract is the most widely read part of a scientific paper. it is worth putting in the effort to ensure that the abstract grabs the attention of your audience with the key components of the scientific paper. dr aiello reviewed how the methods used in journalism could be adapted in the process for writing abstracts. during her presentation, dr aiello reviewed the purpose of an abstract, compared scientific abstracts to news stories, and provided a stepwise approach on how to apply a journalistic approach to writing a scientific abstract. purpose of an abstract an abstract should summarize essential information of the scientific paper, be concise, nonrepetitive, and should be reader-focused. format of an abstract the abstract should present the sections of a scientific paper in the same order (eg, objective, methods, results and discussion/conclusion). dr aiello elaborated on the contents of each section of a paper, and hence the abstract. the objective of the study, or scientific question, should be in the introduction section. the methods section should state how the study was conducted. the results section should include what was found during the study. the answer to the scientific question should be in the discussion/conclusion section. the abstract should be written in a manner that the reader can understand the key points of the study without referring to the scientific paper. the abstract should focus on the question, main methods, results, and conclusion. this can be achieved by being specific and selective. for example, the abstract may include the primary objective, the study result of the primary objective, and conclusion drawn from the study results. if space allows, any secondary objectives and their respective results can be included. how to adopt a journalistic approach in journalism, the lead, defined as the first sentence of a news story, is very important. the standard news lead is typically one sentence and includes all essential information for the reader. the sentence contains the 5 w’s: who, what, where, when, and why. the lead of a news story and the abstract of a scientific article have the following characteristics in common: • the lead of a news story is the equivalent of the abstract of a scientific paper. • after the title, the lead is the first part of a news story seen by the reader. after the title, the first part of a scientific paper that provides context regarding the study is the abstract. • the lead and the abstract are the most read part of a news story and scientific paper, respectively. • the lead of a news story and an abstract of a scientific paper should be able to make sense on their own. table 1 compares which key parts of an abstract correspond with some of the ws of a lead. difference between a news story and an abstract a key difference between drafting a news story and an abstract is why the intended reader should take an interest in the presented topic. in an abstract, the discussion/conclusion section will explain why the results of the scientific paper should be of interest and contribute to scientific literature. this component is not commonly found in a news story. session report journalistic approach to writing better abstracts conference table 1. comparison of the abstract to a news lead part of the abstract “w” of the lead objective why? methods how? results what? discussion so what? http://www.amwajournal.org amwajournal.org 54journalistic approach to writing better abstracts dr aiello provided key points on the method of using a journalistic approach to draft an abstract: • read the scientific paper carefully. – mark key words and sentences. this will be helpful to highlight key components of the paper. • think about the lead technique. – consider the why, how, what, and so what when drafting the objective, methods, results, and discussion sections, respectively. • create a list of all marked material. • edit to condense and refine content. dr tonya scardina is a freelance writer and owner of scardina medical writing & editing llc in chicago, il. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: scardinacommunications@outlook.com a career in medical communication: steps to success learn about the skills and attributes needed to be a successful medical communicator and discover opportunities in the field. www.amwa.org/career_steps http://www.amwajournal.org amwa journal / v36 n3 / 2021 / amwa.org 115 w hether you like it or not, people are getting a lot of their health and medicine information from the internet. some sources of information, such as health care organizations, provide resources for individuals that can help support productive conversations with providers. internet-obtained health materials can improve the patient-provider relationship if the patient discusses what they have obtained with the provider. this dialog can lead to more engaged health decision-making.1 many times, however, people seeking health information online are getting it from social media.2 research by gwi in 2016 showed that 97% of adults between ages 16 and 64 years say they logged into at least one social channel in the last month.3 the misinformation that runs rampant on social media has made headlines. during the current coronavirus disease 2019 (covid-19) pandemic, facebook has started including warnings and notices to users about the possibility that the information they are consuming could be incorrect. users share information without citing sources, fact checking, or even reading the articles they “like” and share.4 this is exactly why health care organizations and health care professionals should be on social media. by sharing credible, high-quality health and medicine information, health care organizations can bring appropriate answers to the place where patients and families are looking. this article describes the approach nationwide children’s hospital has employed to meet the growing need for high-quality health and medicine information on social media. these strategies and tactics are applicable to any health care organization or professional looking to expand their social media presence. the nationwide children’s hospital social media experience organizational social media accounts are an important tool for combating misinformation,2 but that is not all. hospitalowned channels support revenue-driven marketing campaigns, share stories to show organizational culture in support of recruitment and retention, and act as a platform to support customer service needs and respond to reviews and feedback. in the case of negative comments posted online by a patient or employee, sometimes real-time conversations can prevent further damage to the hospital’s reputation. nationwide children’s hospital patient relations team has stopped situations from escalating because they were alerted by a social media post. a parent who has grown tired of their wait time can be deescalated in the waiting room, for example, before further reputational harm occurs. individual clinicians can also make an impact on social media2; think of them as organizational thought leaders. if an individual clinician’s social media work is supported through through education and training opportunities, they can help share accurate and relevant information. twitter, especially, is a place to connect with peers to share research content, amplify speaking engagements, and connect with referring physicians or consumers. in 2020, social media played a large role in attracting candidates who could not tour facilities in person—a trend nationwide children’s hospital social media team expects to continue past the covid-19 pandemic. most importantly, by disseminating evidence-based information, health care organizations or individuals who use social media are in a position to actively combat statediane lang1 and abbie roth, mwc2 / 1director, social media, and 2managing editor, science communication, nationwide children’s hospital, columbus, oh social media social media for the health care organization: sharing for good 116 amwa journal / v36 n3 / 2021 / amwa.org ments that can, at best, be erroneous and, at worst, be a hazard to public health. meeting your audience where they are when you research the origin of social media,5 it is easy to see that online communities are rooted in discussion forums. although archaic by today’s standards, in the early 1990s, people flocked to these digital spaces to connect with likeminded individuals with similar backgrounds. originally filled with gamers and technologists, forums grew to include bloggers and users with varied interests, whether they were crafters, engineers, or people with medical needs. forums and blogs allowed health care consumers to find information on everything from navigating therapies to choosing a doctor. patients and their families came looking for resources, and along the way, they found reviews that guided decision-making and communities that offered moral support. now, clinicians can be part of the conversation. tools for success the first step to success in social media is to analyze goals. are you looking for referrals? are you managing reputation and reviews? are you looking to drive recruitment? maybe it is a little of all three. setting goals will help determine which platforms best suit needs and help guide decisions regarding time dedication, staff allocation, and whether additional online tools are needed. once goals are set, it is important to educate yourself or your team on best practices in social media. just as someone would not perform surgery without a proper education, they should not tweet without one either. improper social media use is a reputational risk. at nationwide children’s hospital, a complete-workforce curriculum trains staff about social media for personal and professional use based on 4 pillars: advocacy, professionalism, awareness, and compliance. navigating the platforms: facebook, instagram, linkedin, twitter, and tiktok, oh my! messages should be tailored not only to an audience but also a platform. dancing doctors can share vaccine efficacy on tiktok, but there is not an audience for that type of performance on linkedin. research studies have a place on twitter, but they are less likely to get traction with a consumer audience on facebook. (see tables 1 and 2.) at nationwide children’s hospital, messaging and audience are tailored to each platform. the nationwide children’s hospital facebook channel supports broad messaging for the consumer audience. human resources has a channel devoted to sharing job postings and content that shares and highlights organizational culture. the nationwide children’s hospital foundation has a channel to share fundraising events and patient stories. some departments also use facebook for parent-focused messaging. in some cases, they host private facebook groups where parents and providers can interact and find support for complex or chronic conditions. on instagram, the organizational channel shares content to illustrate the hospital’s mission. images of patient care, child-life initiatives, and diverse staff reinforce a commitment to advocacy for children and families and show how the hospital provides services to accommodate their needs. visual storytelling makes a culture of inclusion come to life. on twitter, nationwide children’s hospital takes advantage of multiple audience-specific accounts to maximize audience engagement. the main hospital account focuses on communicating broad hospital messages and sharing parentfocused content. the hospital also supports twitter accounts for human resources and trainees as well as others for specific departments and programs. social media table 1. audience types typically found on different social media platforms audience facebook instagram twitter linkedin pinterest tiktok consumers x x x x x health care professionals x x x x donors x x x x staff x x x x table 2. preferred type of messages for different social media platforms message facebook instagram twitter linkedin pinterest tiktok blog post x x x statistics x x x x x job posting x x x x x donor news x x x amwa journal / v36 n3 / 2021 / amwa.org 117 social media the physician/researcher-focused account shares research summaries, new publications, and research-related videos and engages with the audience through topic-specific twitter chats. the twitter chats enable nationwide children’s hospital faculty to use their personally maintained professional accounts to share expertise, engage with experts and trainees around the world, and be amplified by the organization’s accounts. linkedin serves as a recruitment tool where users find job listings and hospital news. the channel can also be used for retention by sharing awards and acknowledgements of current staff or as a place to house long-form posts from hospital administration on strategic initiatives. do you have a registered dietitian with a delicious recipe to share? or a physical therapist who can illustrate kettle bell exercises? pinterest is where consumers can peruse wellness and prevention content and is ideal for blog posts or web content with a visual element. and finally, tiktok. hospitals may shy away from this new kid on the block, but tiktok can get evidence-based content into the hands of a new audience. this unique platform can be utilized by doctors who share prevention information or want to bust myths around everything from vaccines to food allergies. although content can be cross-promoted among organizational accounts, not all content should be. however, too many organizational accounts can dilute the overall brand and add to governance responsibilities. striking a balance can be hard, and in the case of a hospital, once one service line or lab gets an account, they may all want one. it is important for the social media or communication department to have an account approval and governance process in place before getting started. the content connection: social drives pageviews great content is only useful if people see it. sharing content on targeted and curated social media channels helps to ensure that the target audience is seeing what has been produced. for example, pediatrics nationwide is a researcher and physician-focused online magazine. although getting articles from the site to show up in searches (google, bing, yahoo, etc.) is great, it is difficult to determine who is finding and reading it. is the content reaching the intended audience? by sharing pediatrics nationwide content via the researcher and physician-focused social media channels, the channels serve targeted content to our targeted audience—increasing the likelihood that they will read it. on the flip side, that great statistic that is buried in your report or feature article can reach more people and have a greater impact when shared through appropriate social media channels. collaboration for better communication when subject matter experts work together, the product is always greater than the sum of its parts. at nationwide children’s hospital, having medical writing experts, social media experts, researchers, and health care professionals working together has enabled us to develop a network of social media channels that support and benefit from our content channels: blogs, podcasts, research articles, and more. for health care organizations and professionals interested in expanding their social media presence, developing a similar network of experts would serve them well. in addition, the strategies and tactics outlined in this article (understanding goals, identifying audiences and channels, and educating organizational social media users) provide a place to start your social media journey. while you are considering your organizational goals, don’t forget the important responsibility of health care organizations on social media: dispelling myths and providing high-quality health information. author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. author contact: abbie.roth@nationwidechildrens.org references 1. tan ssl, goonawardene n. internet health information seeking and the patient-physician relationship: a systematic review. j med internet res. 2017;19(1):e9. 2. ventola cl. social media and health care professionals: benefits, risks, and best practices. p t. 2014;39(7):491-499, 520. 3. mander j. chart of the day: 97% visiting social networks. gwi website. published june 6, 2016. accessed march 19, 2021. https://blog. globalwebindex.com/chart-of-the-day/97-visiting-social-networks/ 4. culliford e. on facebook, health-misinformation ‘superspreaders’ rack up billions of views: report. reuters website. published august 19, 2020. accessed march 19, 2021. https://www.reuters.com/ article/us-health-coronavirus-facebook/on-facebook-healthmisinformation-superspreaders-rack-up-billions-of-views-reportiduskcn25f1m4 5. the evolution of social media: how did it begin, and where could it go next? maryville university website. accessed march 19, 2021. https:// online.maryville.edu/blog/evolution-social-media/ mailto:abbie.roth@nationwidechildrens.org https://blog.globalwebindex.com/chart-of-the-day/97-visiting-social-networks https://www.reuters.com/article/us-health-coronavirus-facebook/on-facebook-health-misinformation-superspreaders-rack-up-billions-of-views-report-iduskcn25f1m4 https://online.maryville.edu/blog/evolution-social-media/ https://online.maryville.edu/blog/evolution-social-media/ v38 n3 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 38 amwa fellowships are awarded to members in recognition of their significant contributions to the goals and activities of amwa. the 2023 fellows are leaders within amwa with distinguished service at chapter and national levels. barbara o. lightfoot barbara o. lightfoot has been an amwa member since 2009 and has served in many positions in the indiana chapter, including president-elect, president, secretary, treasurer, education committee co-chair, and program chair. in 2019, she received the indiana chapter leadership award. at the national level, barbara has served as a chapter delegate to the amwa board of directors (bod), a member of the national chapter advisory task group, and a chapter representative on the national chapter advisory council. she has also given presentations at local chapter educational events and indiana/ohio valley amwa conferences. currently, barbara is a manager in science communication and regulatory at eli lilly and company. anita misra-press anita misra-press, phd, attended her first amwa meeting in 2010 and has since been an active and engaged member. anita served in many positions in the northwest chapter before it dissolved, including president, president-elect, treasurer, and chapter delegate. she also served on and led several chapter workgroups. at the national level, anita is an active member of the amwa constitution and bylaws committee. she has led roundtables and educational sessions for the amwa conferences and contributed to the amwa journal as a peer reviewer. despite the loss of her chapter, anita has remained active and has continued to seek out meaningful contributions. anita has worked as a freelancer for 13 years. shawn watson shawn watson, pharmd, phd, bcps, rph, has been an amwa member since 2012. at the chapter level, shawn served as president, immediate past president, and chapter delegate of the new england chapter. he also served on the chapter nominating committee. shawn has served on the board as a director at large since 2019. as a director at large, he has served on the diversity and inclusion task force and as the liaison for the engage committee. he has assisted with virtual conferences and publications on salary surveys. shawn has also served on the national nominating committee and the national educational committee. he has authored or contributed to multiple amwa journal articles and has led roundtables and sessions at the chapter and national conference levels. shawn is currently a senior director of clinical development, program team lead, and interim head of medical writing at recursion pharmaceuticals. please join amwa in congratulating barbara, anita, and shawn as they receive their awards this fall at the medical writing & communication conference in baltimore, md. the member awards recognition committee members were abbie miller, mwc (chair), loretta bohn, els (bod liaison), elizabeth brown, ms, pmp, joanne mcandrews, phd, christina barnes, msn, rn, cpnp-pc, jerm day-storms, phd, mwc, and susan aiello, dvm, els. diane noland served as staff liaison, and susan krug, ms, cae, served as ex officio. abbie miller, mwc / 2022-2023 chair, member awards recognition committee amwa fellowships for 2023 amwa news http://www.amwajournal.org v38 n2 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 74 the amwa 2023 medical writing & communication conference will take place october 25th through the 28th in baltimore, within an hour’s drive of amwa’s home offices in rockville, md. the annual conference planning committee, amwa staff, and many, many contributors have been working hard to deliver a great conference. sessions and workshops and posters — oh, my! the annual conference planning committee read, evaluated, and discussed more than 70 thoughtful and well-written proposals for educational sessions. with a packed schedule this year, we could accept only 40 of them, and we’re thrilled with the ones we selected. we think attendees will be, too! the program will have something for everyone, including sessions for beginners, midcareer, and experienced medical communicators. we’re planning to have  9 sessions featuring core knowledge and skills  9 sessions on regulatory writing  6 sessions focused on health communication  5 sessions about career development  4 sessions on scientific publications  3 sessions on wellness  and more! in addition to the educational sessions, we’ll have more than 22 workshops for deeper dives into specific topics relevant to medical communicators. as in years past, most workshops will be held on wednesday and saturday, the preand post-conference days, to minimize conflicts with the sessions. posters will feature additional topics for learning and allow space for networking, too. medwrite talks, short talks given in the tedx style, will offer thought-provoking topics important to medical communicators. and, of course, the schedule will allow time for networking, light snacks, and break time to keep attendees rested and refreshed. follow the yellow, red, and black road to learning the annual conference offers roundtables to give attendees the opportunity to simultaneously learn and network. this year’s conference in maryland (the state colors are yellow, red, and black) will be no different. we are planning to offer several informational and participatory roundtables and will add something new, too: learning circles. we envision learning circles to include 20 to 30 attendees in a conversation about a specific topic. the presentations will be more informational, but the small group size will still allow for networking with and learning from peers. and because technology and tools change at a breathtaking pace, we also plan to offer vendor showcases to highlight our supporters and educate attendees. these showcases will be a chance to learn more about the products and services our vendors offer, see demonstrations of their tools, and perhaps even take some for a test drive. get ready to fly (or drive) home unlike dorothy, the central character in l. frank baum’s the wonderful wizard of oz, attendees won’t be able to click their heels together to magically appear at the conference. (ai technologies aren’t that advanced yet.) so, it’s best to make travel arrangements and book a room at the beautiful baltimore marriott waterfront hotel early to take advantage of the early bird discount. visit the amwa website to learn more. and in making your arrangements, reserve some time to take in the sights and sounds of charm city. harbor tours, museums, historic sites, great food—baltimore has it all. our conference schedule will allow some time to visit the city, but you’ll probably be aching for more—so, indulge yourself! i look forward to seeing you at the conference. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: michele@sequeiramedicalwriting.com there’s no place like home michele w. sequeira, ms, mba, mwc / chair, annual conference program committee conference preview 2023 http://www.amwajournal.org https://www.amwa.org/page/hotel_and_travel amwa journal / v36 n1 / 2021 / amwa.org 51 a m w a news 2020 annual business meeting for amwa members november 9, 2020, 12:30 pm 1:00 pm, eastern time amwa president ann winter-vann, phd, called the meeting to order and provided a report about the accomplishments of the organization over the past year. she acknowledged that the initiatives required many resources. she expressed gratitude to the 2019-2020 board of directors (bod) and committee and task force member volunteers who devoted their time and energy to lead amwa during a challenging year. dr winter-vann also recognized and thanked jim cozzarin, els, mwc, for his 4-year service as editor-inchief of amwa journal. a search committee is currently in place to help find the next editor-in-chief. julie phelan, md, mba, presented a financial report for the period of july 1, 2019, to june 30, 2020. dr winter-vann announced that in accordance with the amwa bylaws, the nominating committee presented the following slate of officers for 2020-2021 to the amwa bod: • president-elect: katrina burton, bs • secretary: r. michelle sauer gehring, phd • treasurer: julie phelan, md, mba the amwa bod approved the slate, and the membership was notified of this slate 60 days before the annual meeting. the amwa bylaws contain a provision for additional nominations to be made in writing, and no additional nominations were received. nominees who are unopposed are elected automatically at the annual business meeting. dr winter-vann declared the slate to be the elected officers for 2020-2021, led by gail v. flores, who as presidentelect automatically assumes the office of president. dr winter-vann passed the gavel to dr flores, who thanked the former for her leadership and expressed appreciation for having her at the helm navigating the organization through this challenging year. dr flores shared highlights from her inaugural address and introduced the 2020-2021 amwa bod: officers: • immediate past president: ann winter-vann, phd • president: gail v. flores, phd • president-elect: katrina burton, bs • secretary: r. michelle sauer gehring phd • treasurer: julie phelan, md, mba • executive director: susan krug, ms, cae cac chair: • kim korwek, phd at-large directors: • brian bass, mwc • loretta bohn, ba, els • sarah dobney, mph • elise eller, phd • jennifer minarcik, ms • lynne munno, ma, ms • laura sheppard, mba, ma • shawn watson, pharmd, phd, bcps the meeting was adjourned at 12:55 pm, eastern time. katrina burton, bs / 2019-2020 amwa secretary 2020-2021 officers ann winter-vann gail v. flores katrina burton r. michelle sauer gehring julie phelan susan krug v37 n3 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 33 i can hardly believe that the fall season is here. this past year has flown by and much was accomplished. as the year heads to its close, i think it is important to reflect on the milestones achieved and lessons learned. when i took on the presidency in the fall of 2021, amwa had just completed the second successful virtual conference. as we look forward to november, i am so excited that we will gathering in denver this year to elevate health and well-being through medical communication. this year’s annual conference committee, led by kimberly korwek, has built a conference program that will meet the diverse needs of the amwa membership. the committee has planned relevant and timely workshops and open sessions to ensure we all continue to grow in our field. if you haven’t registered for the 2022 medical writing & communication conference, i encourage you to review the program and consider joining us in denver. as part of the conference program, i have the honor of presenting the amwa president’s award to j. kelly byram, a member of the southwest chapter. byram has been a devoted amwa volunteer for several years, and amwa has generously benefited from her time and generosity. be sure to read my article about her achievements in the next issue of the amwa journal. i also look to forward to recognizing this year’s john p. mcgovern award winner, and i am excited to join our members in saluting other winners of prestigious amwa awards at this year’s conference. speaking of members, amwa membership continues to grow. our membership is now over 4,600 and growing, and i believe our growth is due to the incredible congeniality of our membership base. we are excited to see such an amazing number of members with diverse experiences and individual talents; and additionally, we appreciate those members who devote their time and expertise to the organization. an important initiative from the past year was the development and establishment of the diversity and inclusion (d&i) assessment task force. the task force, led by dr gail v. flores, is working on identifying how amwa can foster a more diverse and inclusive environment within the organization. i am proud to share that the d&i assessment task force crafted a survey to help gather member perspective on this important topic. the amwa 2022 diversity, equity, and inclusion (dei) survey was recently shared with the entire membership. we hope you are able to participate in this very important survey, as your feedback is important. in addition to the work of the d&i assessment task force, the amwa board of directors (bod) recently approved the organization’s first comprehensive statement on dei. the crafted statement was shared with the d&i assessment task force, the chapter advisory council, and the bod for feedback before the final statement went to the bod for a vote. be sure to read the new statement that is now posted online and in this issue of the journal. special thanks to the staff and members that worked together to make this statement a reality. as i think about amwa’s mission and priorities, i am immensely proud of the work that is happening on the many committees that supports the core values and priorities of the organization. i am looking forward to the new educational programming in the pipeline and other amazing work underway. further, amwa is dedicated to providing top-tier education and networking opportunities for members. even before she became the director of education for amwa, lori l. alexander was a true leader at amwa and was strongly dedicated to the improvement and advancement of education initiatives. i hope as she looks down, she sees what an impact she made on so many lives, and i look forward to the upcoming announcement regarding a legacy tribute to her work. as i close this article, i am reminded of how our journal continues to feed and enrich our membership. interesting and informative articles are published in the amwa journal, and i am looking forward to the preservation of that information in the new online journal system. the hard work and dedication of our new editor-in-chief, michael g. baker, and the amwa staff liaison, shari rager, has resulted in a smooth platform transition that now allows for more modernization. the journal and our organization continue to improve and grow. it is a season in which amwa continues to win, and i appreciate being a part of the journey. from the president a season of wins amwa news katrina r. burton, bs / 2021–2022 amwa president http://www.amwajournal.org https://www.amwa.org/news/511877/a-message-from-the-amwa-president-and-executive-director.htm https://www.amwa.org/news/511877/a-message-from-the-amwa-president-and-executive-director.htm contents v35 n4 winter 2020 201 183 figure 2. word clouds of all social media posts on twitter, facebook and instgram by the top 10 u.s. hospitals in 2019 (top, left) and january-july 2020 (top, right); as well as by the top 10 u.s. medical schools in 2019 (bottom, left) and january-july 2020 (bottom, right). figure 2 177 feature science series sars-cov-2 and influenza virus: a comparative look at their relationships with the respiratory system � jennifer l. busch feature practical matters medical communicators, meet your new authors—patients! � karen l. woolley and tom gegeny reprint research ethics is a tricycle not a unicycle: the role of researchers, reviewers and editors � sam dragga and dan voss research social media harnessing the power of social media to enhance health communication � wenyou ye and liviu aron creative writings mentorship is a sanctuary � jodi-ann edwards reprint achieving a work-life balance as medical writers � barry drees practical matters 16 tips for nurturing clients into long-term relationships � katherine molnar-kimber, thomas drake, brian bass, and nicole cooper freelance focus � melissa l. bogen, lori de milto, and phyllis minick our contributors were asked to comment on “16 tips for nurturing clients into long-term relationships” 161 168 172 177 182 183 186 190 contents editor james r. cozzarin, els, mwc managing editor jennifer workman section editors around the career block lauren mcmahon, pharmd media and technology tara ann cartwright, phd practical matters qing zhou, phd, els regulatory insights jennifer bridgers, ms, mwc science series paul c. dolber, phd social media jennifer minarcik, ms statistically speaking thomas m. schindler, phd everyday ethics julie ravo, ba, ma members matters govindi (jaya) samaranayake, phd regular contributors freelance focus ruwaida vakil, msc brian bass, mwc melissa l. bogen, els sherri bowen, ma, els lori de milto, mj cathryn d. evans gail v. flores, phd phyllis minick in the service of good writing laurie endicott thomas, ma, els editor at large haifa kassis, md editor emeritus lori l. alexander, mtpw, els, mwc editor in memoriam ronald j. sanchez 2019–2020 president ann winter-vann, phd 2019–2020 board liaison/ at-large director r. michelle sauer gehring, phd, els, cra 2019–2020 staff liaison shari rager, ms, cae executive director susan krug, ms, cae graphic designer amy boches, biographics editorial office: managingeditor@amwa.org. instructions for authors available at: www.amwa.org/journal. advertising: contact marketing@amwa.org or (240) 239-0940. all advertising is subject to acceptance by amwa and should be for products and services relevant to professional medical communicators. amwa is not responsible for the content of advertising and does not endorse any advertiser or its products or services. subscription: the amwa journal is published quarterly. subscription is included with amwa membership. nonmember subscriptions cost is $75 per year. contact: american medical writers association, 30 west gude drive, #525, rockville, md 20850-4347. phone: (240) 238-0940; fax: (301) 294-9006; email: amwa@amwa.org. the amwa journal is in the mla international bibliography and selectively indexed in the cumulative index to nursing and allied health literature (cinahl) print index and the cinahl database. the opinions expressed by authors contributing to the journal do not necessarily reflect the opinions of amwa or the institutions with which the authors are affiliated. the association accepts no responsibility for the opinions expressed by contributors to the journal. ©2020 american medical writers association. all rights reserved, worldwide. issn 1075-6361 amwa journal mission statement in support of the mission of the american medical writers association (amwa) and to advance the broader profession, the amwa journal publishes content that reflects the interests, concerns, and expertise of medical communicators. its purpose is to inform, inspire, and motivate medical communicators. m o r e v35 n4 / 2020 191 calendar of meetings 192 members matters the covid-19 pandemic has led our south florida networking group to an important discovery: the true value of networking � larry lynam, marie n. becker, and shara n. pantry 196 members matters zoomzoom! how to get your chapter programs back on the road � j. kelly byram and mia defino 201 original article a new credential for my cv: zoom concierge � carolyn bernstein 203 amwa news from the president / inaugural address � gail v. flores announcing the 2020-2021 amwa board of directors � gail v. flores a note of appreciation � r. michelle sauer gehring 206 from the editor last word � james r. cozzarin mailto:managingeditor@amwa.org http://www.amwa.org/journal mailto:marketing@amwa.org mailto:amwa@amwa.org contents mission statement, masthead v37 n3 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 9 last month in the amwa journal, you may have read the first installment of the review of the popular annual conference session, the jam session for seasoned freelancers. here we summarize and discuss the experiences, ideas, concerns, and challenges faced by seasoned freelancers that there wasn’t space for in last month’s issue. if you missed last month’s article, we reviewed managing stress; email, travel, and security issues; and sculpting your business. here, we discuss doing business with friends, referring clients, legal battles, and one of the costs of doing business. * * * the friend zone when a seasoned freelancer finds themselves working with a friend and an issue or a concern arises, the best thing to do is leverage the friendship to be honest and transparent— something you might not be able to do if the person were not a friend. explain what isn’t working and why and ask for help to make it work better. be proactive and act quickly so the issue doesn’t fester. problems are much easier to resolve when they’re small. tips from seasoned freelancers it is my view that, when working with one of your personal friends, the reporting structure should be quite clear. [in fact, whether working with a friend or colleague—freelance or as an employee—the reporting structure always should be crystal clear. there is no such thing as a “lateral hierarchy.”] when i hire a friend, i expect them to follow my direction; if they have opinions that differ, i definitely wish to hear them and often have changed something based on input from others who work with/for me. but my vote is the final vote if the person has been hired by me. if a person is truly a close personal friend (outside of any business relationship), then i expect that we would be able to speak together honestly and try to compromise. however, if actual friction occurs and it seems impossible to resolve, then decide whether you want to keep the friend or the project/ client—and eliminate one of them. —cathryn d. evans at an amwa national conference in san diego several years ago, i encountered a young woman who had been in a workshop with me, and we chatted about issues raised by the speakers. of course, the matter of “getting started” as a medical writer arose. numerous workshop attendees had complained about related difficulties and obstacles. engaging with the 50 or so eager faces surrounding me, i felt obliged to say, “in this room, i see and hear individuals who are educated, energetic, and eager. i can’t help but say, have faith in yourself! never stop trying. back away from any failed attempts. focus on your eagerness for new opportunities. seek new options.” subsequently, that young woman took a new job. the pay was terrible, and the working conditions were worse. but she has kept in touch with me and has recalibrated to a different job. she is still a “work in progress, ” but she continues to correspond with me and actually has improved her working life. each of us has gained a new friend! —phyllis minick * * * matchmaking some seasoned freelancers manage their workloads by referring clients when they’re either not the right person for the job or already committed to another assignment. when you’re ready to make an introduction, first contact each person involved to make sure they’re aware and on board. then, send an email to both the client and the person you’re referring to them. introduce them to each other and say something relevant and complimentary about each of them. end the introduction by wishing them both well and brian bass, with commentary from cathryn d. evans, phyllis minick, and sherri bowen jam session for seasoned freelancers—part 2 freelance focus sherri bowen phyllis minick http://www.amwajournal.org amwajournal.org 10freelance focus reminding the client that you look forward to working with them when the next opportunity arises. some seasoned freelancers make so many referrals that they keep a spreadsheet of who they refer and to whom. tips from a seasoned freelancer if i am unable to take on a particular project for a prospective new client because of my schedule, i will give the person the name and contact information (email and telephone number) of a qualified colleague who might be able to fit the project into their schedule. i will recommend the person based on my personal experience working with them. if this exchange is by telephone, i will follow up with an email to the person i recommended with the name and email of the new client. if a long-term good client needs something and it is nearly impossible to fit it into my schedule, i will try to make it possible to fit it in, even if it means working nights, etc. i have referred a number of such new clients to other writers but have not followed up to see if the connection worked out; some writers do email and thank me. —cathryn d. evans * * * lingering legal battles it has been a few years since california enacted ab5 and threatened the livelihoods of freelancers everywhere. since then, the covid-19 pandemic has taken center stage, but seasoned freelancers know they need to remain vigilant and vocal and do everything possible to show that their freelance business is a real business. this includes establishing your freelance business as a recognized business entity, such as an llc or s-corp, and describing your freelance business as a vendor rather than as a contractor. tips from a seasoned freelancer years ago, a member of this freelance contributors group advised all of us to insert in each of our work contracts a “hold harmless” clause. she cited a coworker who had written medication instructions for a pharmaceutical company’s package insert. a patient sued that company, and the writer was also sued. i later included a similar hold harmless clause in my contract as a freelance writer with a major pharm company. the company agreed to my contract without question. anyone accepting this suggestion should have an attorney write that clause for their personal situation. —phyllis minick * * * the cost of doing business seasoned freelancers have noticed an increasing number of clients requiring their vendors to participate in standard operating procedure (sop) training, sensitivity training, and other similar programs. should you charge for your time? you bet! employees of the company are required to go through the same training and their salaries are not docked for the time, so freelancers should not be financially penalized either. when a client asks you to participate in an internal training program, simply ask them how they want you to invoice for it. if they balk about compensating you for your time, consider it a red flag. tips from seasoned freelancers of course the freelance writer/editor should charge for any time required to study a new client’s sops and other training material! it should not even be a question. but if you are not sure, just tell the client, “okay, i will charge this time at my normal hourly rate of $xxx and invoice you once i complete the training.” especially if the project you are about to undertake is based on a fixed-fee bid, you should communicate that all extra activities not associated with the specific project, as outlined in your contract, will be charged hourly—just to be certain that the client does not think your training is part of the project bid. —cathryn d. evans absolutely, you should charge for this kind of training time! in fact, all your time spent on behalf of a client's business— whether it be training or even time with the it staff to fix issues with your client-issued laptop computer—should be billed at your regular hourly rate. i have never had a client balk about compensating me for training time, especially since it's their requirement that i complete such training. i have also never asked ahead of time how they want training time to appear on an invoice. i just include a line item for training (and a separate one for "it issues," when necessary) on my invoices. i do recommend printing or saving a copy of any type of confirmation of your completed trainings. some companies record your training module compliance automatically in their internal system, but it's a good idea to keep a copy for yourself, just in case of any future disputes. —sherri bowen http://www.amwajournal.org v37 n4 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 54 the recipient of the president's award is selected by the amwa president, and each year this award is bestowed upon a member of amwa who has made distinctive contributions to the association at the chapter or national level. i am delighted to recognize kelly byram, ms, mba, els, as the 2022 amwa president’s award recipient. kelly, a writer, editor, and founder of duke city consulting, llc, received the award in november at this year’s medical writing & communication conference in denver, colorado. since kelly joined amwa, she has served at both the chapter and national levels. she is the immediate past president of the southwest chapter that spans texas, louisiana, arkansas, oklahoma, and new mexico. in 2017, she volunteered to serve as an at-large-director for new mexico, hosting networking events in albuquerque and santa fe and has served in that role many years. in this role, she recognized the work taking place at the chapter leadership level, so when she was asked to take on a chapter officer role, she didn’t hesitate. kelly took the chapter to new heights as assistant program chair, introducing the chapter to new and regular programming events with a variety of talented guest presenters. she then served as program chair, presidentelect, and president. at the same time, kelly was sharing her expertise at the national level leading several roundtables and open sessions at the annual conference and writing articles for the amwa journal. kelly also served as co-chair of the southwest chapter’s john p. mcgovern award committee, and as a member of the chapter’s nominating committee. she regularly serves on panels and presents on various topics of interest including writing, editing, technology, and career spaces. ongoing volunteer work for the chapter includes technical assistance projects, such as migrating the chapter website and designing and implementing surveys. she also manages the integration of technologies to support the chapter’s operations and programming efforts. she was a key part of helping the chapter migrate to the virtual environment during the pandemic and has helped chapter leadership continue to deliver important educational content. her most recent role was serving on this year’s annual conference committee helping to pull together an amazing program for the 2022 medical writing & communication conference. it’s been a wonderful experience seeing kelly lead the chapter, share her expertise with amwa members, and venture into the national realm of volunteerism for the organization. when i asked kelly about why she volunteers, here is what she had to say (email communication, 27 july 2022). “volunteering helps members build their networks and refine their skills, and it provides opportunities to build new skills. from another perspective, as we move through our careers it's important to give back to the community by contributing our time, experience, and expertise, and volunteering provides opportunities to do that. on its own, membership in amwa provides ample benefits and, if you take advantage of all amwa has to offer, you will grow in your practice of the profession. volunteering amplifies those benefits.” it is an honor to present kelly with this well-deserved honor. please join me in congratulating kelly on her contributions to amwa and for being this year’s president’s award recipient. katrina r. burton, bs / 2021–2022 amwa president 2022 president’s award recipient: kelly byram, ms, mba, els amwa news http://www.amwajournal.org amwajournal.org 20session reports colleagues, it can be complicated because you’re editing someone else’s editing, so it’s important to check your ego at the door. dr herron suggested specifically that freelancers try to find another editor that they can trust and learn from because, most of the time, freelancers are working alone. ms bohn also added to this by emphasizing the importance of having a more organized approach when meeting with someone and suggested cross-teaching so you can learn from each other. working remotely ms bohn began by mentioning that the skills are the same, but mentoring someone that you aren’t in the same room with requires a unique approach. ms goodoff chimed in and agreed that the core editing skills are the same, but the presentation of the information is different when working remotely. she had to learn a lot of new technology and noted that you don’t get the same chance to rely on audience reactions, but you can write a tentative script while presenting on zoom. dr herron added the suggestion that you can post a sticky note with a person drawn on it near your camera; that way you have “someone” to talk to and look at near the camera, which will help your audience connect with you. ms bohn closed by suggesting a fake commute at home, something that signifies the beginning and the end of your workday. angela trenkle is a preclinical technical writer at bioqual, inc., and is based in the washington, dc, area author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: angelatrenkle@gmail.com * * * remote but not alone: navigating difficult personalities when you work from home speaker melissa christianson, phd, whitsell innovations, inc., chapel hill, nc by stacie marsh, mpa, cph, gpc collaborative medical writing requires leadership from professional medical writers to guide teams of people toward the common goal of completing documents with clarity, precision, and adherence to third party guidelines, often within challenging timeframes. medical writing teams typically include groups of individuals from widely varying backgrounds, areas of expertise, priorities, pressures, and communication styles. medical writers must foster effective teamwork in order to successfully lead their teams toward achieving their common goal. the pandemic has forced more writing teams to collaborate in a virtual environment, requiring medical writers to recognize and navigate team dynamics and interpersonal intricacies in creative ways. dr christianson’s presentation at the american medical writers association (amwa)’s 2021 medical writing and communication conference identified the most common personality types among difficult members of medical writing teams and provided specific strategies for navigating these traits in a virtual environment. defining and recognizing difficult behaviors the first step in dealing with difficult behaviors is recognizing that they exist. although perceptions of difficult behaviors vary by the individual assessing the behavior, difficult behaviors and attitudes typically refer to those that are misaligned with the expectations of the writer and the team. dr christianson illustrated the most common types of difficult behaviors in a behavior categories axis (figure). group 1 includes those who are narrowly focused with tendencies to approach a project in a way that mismanages the writers time, attention, and processes, and ultimately impedes the writer’s ability to move a project forward in an optimal timeframe. examples of group 1 traits include micromanagers, digressers, know-it-alls, worriers, and wordsmithers. those in group 1 may be concerned about proving their own worth or getting blamed for less-than-optimal outcomes for reasons such as job vulnerability or being new in a position with perhaps lesser credentials that other team members. group 2 includes those who are more broadly focused but aggressively approach projects. these behaviors conjure *this manuscript is based on a session at the 2021 amwa medical writing and communication conference. figure. top left (group 3); top right (group 1); bottom left (group 4); bottom right (group 2) group 2 includes those who are more broadly focused but aggressively approach projects. these behaviors conjure an elephant barreling through a meeting, causing chaos in their wake. examples include those with strong egos, often short tempers, and who are prone to derail a team’s progress in unpredictable ways. individuals displaying these tendencies may not realize the value of writers in handling important team functions. group 3 includes those who are more narrowly focused on a project yet withdrawn or disengaged from specific tasks at hand. these individuals tend to be reticent to voice their opinion or make an important contribution until a problem arises, vacillate, and fail to provide clarity to move forward, stall a meeting’s progress, and generally underdeliver on their intended roles and contributions. reasons for these behaviors can be attributed to cultural complexities, competing priorities, and simple unawareness of what is expected of them as part of the medical writing team, among others. finally, group 4 includes those who approach a project from a broad perspective but whose actions withdraw from the functions or goals of the team. individuals displaying these characteristics tend to be pessimists, complainers, rumormongers, blamers, deceivers, and dismissers. unfortunately, these are often the most common types of difficult behaviors and influence the tone and dynamic of entire teams in a negative manner. these behaviors are often exacerbated by—and sometimes a result of—ineffective communication from project leaders, including medical writers leading cross-functional teams. dealing with difficult behaviors approachwithdraw narrow focus broad focus reticent vacillator under-deliverer staller micromanager worrier know-it-all rumormonger pessimist dismisser complainer blamer deceiver tank exploder egoist digresser wordsmith figure. top left (group 3); top right (group 1); bottom left (group 4); bottom right (group 2). http://www.amwajournal.org amwajournal.org 21session reports an elephant barreling through a meeting, causing chaos in their wake. examples include those with strong egos, often short tempers, and who are prone to derail a team’s progress in unpredictable ways. individuals displaying these tendencies may not realize the value of writers in handling important team functions. group 3 includes those who are more narrowly focused on a project yet withdrawn or disengaged from specific tasks at hand. these individuals tend to be reticent to voice their opinion or make an important contribution until a problem arises, vacillate, and fail to provide clarity to move forward, stall a meeting’s progress, and generally underdeliver on their intended roles and contributions. reasons for these behaviors can be attributed to cultural complexities, competing priorities, and simple unawareness of what is expected of them as part of the medical writing team, among others. finally, group 4 includes those who approach a project from a broad perspective but whose actions withdraw from the functions or goals of the team. individuals displaying these characteristics tend to be pessimists, complainers, rumormongers, blamers, deceivers, and dismissers. unfortunately, these are often the most common types of difficult behaviors and influence the tone and dynamic of entire teams in a negative manner. these behaviors are often exacerbated by—and sometimes a result of—ineffective communication from project leaders, including medical writers leading cross-functional teams. dealing with difficult behaviors learning to proactively identify potentially challenging team dynamics and communication styles—and the context in which these behaviors may be based—can help writers anticipate and prevent problems before they arise, or at least limit their impact. dr christianson suggested early actions, ongoing strategies, and meeting solutions for each of the 4 groups. following these practical tips will ensure that crossfunctional teams collectively and efficiently achieve their common goal of producing a clear, compelling, and compliant final product. the presentation included practical strategies to assert writers’ leadership roles and assess team member characteristics in order to identify potentially difficult behaviors and mitigate their impact early in a project. for example, writers should confidently articulate their qualifications and their roles as writers and project managers at the outset of a project, followed by detailing the roles, expected contributions, and associated timeframes for all other team members. writers may want to consider holding a pre-kickoff meeting with a team representative prior to the formal kickoff in order to get a feel for team dynamics and personality traits. during the kickoff, writers should encourage team members to turn their cameras on in order to match voices/ behaviors/tones with names and visibly monitor problematic behavior. the kickoff meeting should establish ground rules and timelines expected of all team members for the project duration. writers may also want to consider assigning a note taker for meetings so they can focus on the task at hand as they tune in to team dynamics. clear and consistent communication is paramount. writers should be very clear about what they need from individual team members and communicate with them directly if needed. timed agendas sent in advance of each meeting, as well as emails using the “bottom-line-up-front” approach are also helpful in keeping difficult behaviors in check. medical writers have immense power to lead writing teams in a way that fosters productive, collegial behavior. if difficult behaviors arise despite adherence to these proactive strategies, writers should remain professional, positive, solutions-oriented, firm, and confident in their leadership to keep teams moving forward toward their common goal. stacie marsh is a medical writer at words for good, inc. based in charlotte, nc. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: stacie@wordsforgood.com * * * medical writers have immense power to lead writing teams in a way that fosters productive, collegial behavior. http://www.amwajournal.org listen to our podcast available on apple podcasts, google podcasts, and spotify become a medical writing master visit us at trilogywriting.com writers@trilogywriting.com www.trilogywriting.com/trilotalk think you have what it takes to join a world-leading team of medical writers? we’d love to speak with you. a m w a news slate of officer candidates for the 2021-2022 election katrina r. burton / 2020–2021 amwa president-elect one of the duties i’ve enjoyed most about serving as presidentelect is the opportunity to chair the nominating committee, a group appointed by me and charged with selecting a slate of amwa officers for the 2021-2022 service year. many thanks to members serving alongside me on this year’s nominating committee, including cyndy kryder, ms, mwc; tenille l. lawson, pharmd, bcps; julie munden, ba; rajalaxmi natarajan, phd; joanna pendergrass, dvm; jill roberts, ms; theresa e. singleton, phd; and susan krug, ms, cae (amwa executive director), an ex officio nonvoting member. each year, interested members are invited to submit a board of interest form for consideration of 1 of 3 elected offices: president-elect, secretary, and treasurer. the nominating committee reviews the forms and qualifications of candidates who meet the criteria and collectively agrees on a candidate for each officer position to submit to the board of directors (bod) for consideration. i’m honored to present the following candidates who were presented and ultimately approved by the bod at the june meeting: • president-elect: elise eller, phd • secretary: r. michelle sauer gehring, phd, els • treasurer: julie phelan, mba, md president-elect elise eller, phd, an amwa member since 2009, is currently a director-at-large on the amwa bod and is the chair and board liaison of the member awards committee. previously, she was chair and board liaison for the 2019-2020 annual conference program committee. she was board liaison for the chapter leader community in 2018-2019; served on the chapter advisory council task force, the constitution and bylaws committee, and the chapter support committee; and chaired the chapter handbook committee in 2014. at the chapter level, she organized the 2011 and 2013 chapter conferences for the rocky mountain chapter and served as president of the rocky mountain chapter from 2013 to 2017. she also served as chapter delegate to the amwa bod from 2012 to 2017. originally a freelance medical writer, elise is now a medical writer and consultant at whitsell innovations, inc. elise lives in colorado, where she likes to hike in the foothills above boulder. secretary r. michelle sauer gehring, phd, els, an amwa member since 2009, is in her third year on the bod (since the 2018-2019 term) and currently serves as secretary and liaison to the amwa journal. previously, she served on the annual conference planning committee from 2013 to 2020, chaired the committee for the 2019 annual conference in san diego, and was a member of the most recent editor-in-chief search task force. at the chapter level, michelle served as the treasurer (2012-2016), program chair/president-elect (2016-2017), and president (2017-2018) of the southwest chapter, as well as chapter conference committee chair from 2015 to 2018. at the national and chapter level, she has led multiple open sessions, webinars, and roundtables on grantsmanship, research development, copyright laws, and professional development in the academic and freelance sectors. in addition, she teaches amwa's ethics for science and medicine workshop and multiple medical writing courses for the university of california san diego extension. she has authored and contributed to multiple amwa journal articles and serves as a peer reviewer as needed. when michelle isn't teaching or volunteering for amwa, she serves as the senior research scientist for the university of texas health science center at houston's center for advanced heart failure, the copyeditor of pursue, and the managing editor of the vad journal. michelle is also the co-owner of rna editing, llc, and resides in texas with her husband and 2 daughters. amwa journal / v36 n3 / 2021 / amwa.org 129 treasurer julie phelan, md, mba, an amwa member since 2009, is in her fifth year as treasurer on the bod and as chair of the budget & finance committee (2016-2021). she has previously been a member of the budget & finance committee (20152016), the communications committee (2014-2015), the 2015 salary survey task force, and the online community and social media committees (2012-2014). at the chapter level, she was president of the greater chicago area chapter (2013-2016), serving previously as president-elect (2012-2013). she also served as membership chair for the chapter (2011-2015) and as a chapter delegate to the board (2013-2016). she has written articles for the amwa journal and currently serves as amwa’s registered agent. she was awarded an amwa fellowship in 2017. julie is president of biomedisys, inc, and enjoys fishing. procedure for additional nominations as required by amwa’s bylaws (article iv.2e-f), these nominations were announced to the amwa community by email more than 60 days before the annual business meeting. a nominee who is unopposed for any office is declared automatically elected at the annual business meeting. as stated in the bylaws, additional nominations for president-elect, secretary, or treasurer may be made by any member provided the member meet the criteria set forth by the bod. the criteria and process is listed below: • member dues must be current, and member must be in good standing • nomination is submitted in writing to the secretary of amwa at least 30 days in advance of the annual business meeting. this year’s annual business meeting is scheduled on november 12, 2021 • nomination must clearly state the qualifications of the candidate and be signed by 50 members in good standing as of the date of the receipt of the nomination • nomination must be accompanied by a letter from the candidate stating that he or she is willing to serve if elected amwa live webinars tools, tips, and tricks for medical communicators. www.amwa.org/events only $20 for members can’t attend a live webinar? you won’t miss out! all registrations for live webinars include access to the recorded video in amwa online learning. 130 amwa journal / v36 n3 / 2021 / amwa.org a m w a news http://www.amwa.org/events v37 n4 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 6 abstract key thought leaders discuss their views of the evolution of medical communication focusing on their grand visions for medical communicators, what we learned from the pandemic, and what will be required in the future. topics touch on the impact of developing technology, communicating with the public, managing social media, standardizing education requirements, and preparing the next generation of medical communicators. introduction in this contribution to “crystal ball” musings, diverse thought leaders chimed in on their visions of medical communication and medical writing in 10, 15, and 20 years. three seasoned professionals from different areas of medical communication provided commentary: • ms joan affleck, associate vice president-medical writing, merck & co., inc • dikran toroser, phd, cmpp, senior director, publications, merck & co., inc • genevieve walker, phd, freelance medical writer, bridge health communications the moderator’s (dr suzanne devandry) prompt is provided for each topic, followed by the responses of panel participants. each perspective offers insights on some of the vital questions of our day. what is the grand vision for medical communicators? how do we become the people who can help humans around the globe understand what they need to do to be healthy and how to meet the challenges when certain life-changing events occur? genevieve walker: my grand vision for medical communicators is that we continue to be facilitators in getting health and science information to the people who need it. regulatory bodies. the fda. members of the public. the “worried well”—people who aren’t sick but who really crave health information. we should facilitate getting it to these audiences clearly, with as few frills as possible, and with as much need to know as possible. joan affleck: some factors need to be brought into consideration. we hear a lot about digitization in the press, and some people view digitization as the prioritization of data over words and messages. that’s actually a piece of misinformation. data support the messages. and we need the messages. if we learned nothing else from the pandemic, it was that too often people don’t understand the messages, and sometimes the messages aren’t clear. it should be a real reminder to us that when we start thinking about prioritizing data, it means the messages are even more important. we need to be able to explain what those data say, how to interpret them. this will become more and more important—the creation and curation of messages. i think it is vital to the work of medical communicators today. dikran toroser: medical communicators are going to be the gatekeepers to make sure that our stuff is stamped with dependable, peer-reviewed credibility. the speed at which communications have been produced … the speed at which things have reached the literature … the involvement of medical writers … the type of work that medical writers have been asked to do … the type of output in which medical writers are involved … all the changes are just staggering. and all of this is happening right now. as medical communicators, we have to keep on top of this, because we hold the gate—the gate where authors speakers joan affleck, mba / associate vice president-medical writing, merck & co., inc, rahway, nj dikran toroser, phd, cmpp / senior director, publications, merck & co., inc, rahway, nj genevieve walker, phd / freelance medical writer, bridge health communications, portland, or the evolution of medical communication theme article suzanne devandry, phd, rn / executive director, medical writing, merck & co., inc, rahway, nj http://www.amwajournal.org amwajournal.org 7the evolution of medical communication are involved with what is done ethically, with who gets the data. we are at the center of most things. so i think these are exciting times. how do you see the evolution of medical communications through the next 10 to 20 years? joan affleck: i’ve been thinking about this a lot actually. it’s one of my preoccupations. when i think of medical writing 15 to 20 years from now, for me, that means anybody who is 55 years [old] or younger in medical communication has a major stake in this conversation and should be participating in it. i feel we’re missing those voices. one of the things i think about is how to bring them into the conversation. i am not planning to be working as a head of medical writing at merck in 20 years. i may be doing something else, but i’m not going to be head of medical writing at merck. i want someone else to do that job, and i want somebody else to be shaping the profession. genevieve walker: patient engagement has really skyrocketed since i entered medicine in 1990. we have much more available for patients to access. we have much greater need and a drive for people to be involved in their own health and health care, be it changes in insurance, clinical care, regulations, or whatever else. people have a lot more responsibility and a lot more options than they once did. so i think that my sector of medical care—health education, patient education—is a growing part of the field. dikran toroser: in the last few years, work in day-to-day jobs as well as the final output has become more electronic. the job has become pretty much paperless. during the pandemic, a lot of companies got caught unaware. forms for clinical trials used to be paper … and suddenly, you couldn’t get from a to b. everything is searchable at a speed we had no awareness of a couple of years ago. i can find things in a database within minutes, look up congresses, find abstract requirements, touch base with medical communicators. so that’s been a major development. we’ll be software dependent. it’s going to be a long time before a clinical study report will be written by a machine. we’ll always need people, but things are going to get much faster because some of the routine aspects of our work will be handled by artificial intelligence. genevieve walker: there was a time 10 or 15 years ago when we were concerned that medical communication would be outsourced to large content mills. but because medical communication is pretty high touch and the language is usually quite high level, it requires very careful handling. the outsourcing didn’t happen the way that we thought it would. my concern now is that we keep that hands-on high touch. let’s respect that very careful and compassionate way of working with the words around medicine and health while we are separated. in a big medical writing department, say at merck or at the university of texas, people may have worked together in an office for many, many years. there is a give and take, a flow, that goes on when humans are together. that may not be very visionary. on the other hand, it might be all that we need. what has the pandemic taught us? what things have happened or what things have we learned from the pandemic that we will want to continue to move forward and develop? genevieve walker: we have a couple of things going on with science medicine and the public that became very clear in the pandemic. we have folks who are able to do their own research, who understand a concept like risk or a concept like relative risk. then we have a vast number of people who have no idea what that means, who have no way to calculate their own risk. we have people talking about disease and health care who are in no way related to disease and health care and really should not speak about it. it causes a lot of frustration. the pandemic highlighted that science can be politicized to serve the ends of almost anyone. so one lesson i see is the repeated lesson. science is hard to understand in patient education. the lesson for us is to present information simply. not dumbing it down. simplifying it: clear. short. usable. do this, not that. and communicating to people that you have rights, and you have some responsibility for yourself—those are important lessons for good or for ill that came out of the pandemic. joan affleck: you know, the veil was pulled back, and we could see that most people in this country, in the united states, do not have a high level of health literacy or numeracy, and i’d be willing to bet that the competency is not that much better around the world. maybe in a few countries it is, but in general that literacy and numeracy are poor. http://www.amwajournal.org amwajournal.org 8the evolution of medical communication so we’re going to have to think about real ways to be able to test information to know whether it’s comprehensible to people and to figure out new ways of delivering that information. we just can’t go on the way we’ve been doing things in the past. what we were doing before is not going to get us to where we want to be in the future. dikran toroser: because of the pandemic, the format of communication really morphed into various types of media—voice, video, and others. there's a lot more output and it's going to be available whether we like it or not, in lots of venues. it's not just going to be in pubmed. it's also going to be leaked out in social media. some of the [other] changes from the pandemic will stick. for example, i don’t think we’re going to be in the office 5 days a week anymore. we’re wiser about how inefficient that is. at the same time, i don’t think we’re going to be remote 100% of the time. we just lose so much by being remote all the time. and we need things like our congresses, where the medical communicator interacts with stakeholders, rubs shoulders with people doing analysis … you know, being there at the inception of the concept. that stuff i think has to happen face to face. what is the role of education and certification in establishing a consistent quality of practice in medical communication? joan affleck: this whole question of the competency of professionals and the quality of our work keeps me up at night. how do we continue to show the value of what we do? how do we convince others that ours is a special skill set? are we going to look at academic education, apprenticeships, certification, continuing education requirements? these are some of the standard professional benchmarks. or we could go to some totally new paradigm. the point is that we have to do something. again, this is where we need the voices of people who are mid-career to help steer the profession into the future. i challenge people under age 55 to step up and get involved. if you don’t know how, call me. we’ll talk about it. dikran toroser: you’ve got to be familiar with your guidelines. i’m a cmpp-certified medical publication professional. i took the exam to be cmpp qualified, and i attend the meetings and have peer review. many of us are actually editors for journals. i interact with a number of clinical journals, and peer review is not just off the top of your head. training will be required to make sure that you look at things in a nonbiased manner, that you view things appropriately. there’s a lot of training to keep up with the field, and it’s expected. my recommendation is for new aspiring medical communicators to get in with the local amwa chapter. i’m in boston, and the northeast chapter is brilliant. you have to make contact with people. that’s the way it works. genevieve walker: i don’t feel there should be one standard for every type of medical communication. i know that amwa has made great strides in developing a medical writer certified designation with a test. however, what if we had a certification process that really reflected the differences among types of medical communications? i think it’s really important, because folks who are generally good at regulatory writing often can’t do writing for patient education and the public. those are different skill sets, different mindsets. they’re different backgrounds, and maybe even different imaginations. i would love to see education and certification going more in a direction that mirrored what we do to certify physicians, where you pass a board exam in your specialty or related specialty. i think it would be preferable to have separate certifications. what do the medical communicators of the future need to be successful? dikran toroser: cultural awareness. many of our companies are global, but suddenly the medical writer is having to interact with someone in china, someone in japan. there are cultural differences. there are certain ways to behave if you actually want to get done what you need to be done. so cultural awareness is number one. number two is that you can’t drop basic things like grammar. grammar is always this whole question of the competency of professionals and the quality of our work keeps me up at night. how do we continue to show the value of what we do? how do we convince others that ours is a special skill set? —joan affleck http://www.amwajournal.org amwajournal.org 9the evolution of medical communication important. finally, you need a simple awareness of what to do if you’re contacted by a predatory journal. you need to recognize it. you need to recognize the url address. if it’s from somewhere that’s suspicious, you need to warn your authors. so, it’s a diversity of skills. joan affleck: unfortunately, today we do a lot of templated work – agencies give us templates to fill in. our future depends on having people who think a lot more freely outside of a template, beyond just plugging in information here and there. we want people who understand that. medical communication is at the intersection of data and messages, all the way from the protocol throughout the life cycle. our work requires multiple points of view, and medical communicators really need to be thinking of the role holistically. medical communicators need to be at the right tables, whatever those right tables are talking about. we need to be educated about the capabilities and limitations of our profession and be forward-thinking in terms of what we’re going to need to help design programs, platforms and systems, their interoperability. a big question is how do we control information, the way reputable newspapers and journals manage it? how do we lock down what the real message is? how do we win that credibility with the public? i don’t know the answer to that, but it’s a problem for us. i think in regulatory medical writing we’ve had a small lens. we’ve been thinking our work is just for this company, not anything bigger. we need to blow that attitude apart. we need to acknowledge that we are a crucial part of a global public health network, and we need to participate in that. genevieve walker: we are here to communicate. we are here to be great conduits and interpreters, not to promote specific findings or points of view. i actively discourage people from believing what they read on twitter, facebook, etc. as we’ve seen, those platforms aren’t channels of communication per se. they have agendas behind them, no matter whose it may be. there are lots of channels, and each one is a business. somebody’s making money, and they’re making money off you. so i think we need to refresh people’s memories. there’s quality. and then there are junk sources of information. we need to be pretty clear about that. that would be a good stand for medical communicators to take. success is easier with an attitude of service, an eagerness to learn, and a spirit of willingness. we have an enterprise centered on the patient—centered on the person who needs information. and we are all in service of something greater, which is access to health. suzanne devandry: thank you to our panelists for sharing your thoughts and vision of the evolving field of medical communication. in response to our questions, we heard several common themes about the benefits and challenges of working in a virtual environment, the need to extend the vision of medical communication to include global health literacy, the urgency of building trust with patients and providers, learning from the pandemic how information may be used and misused, and preparing the next generation of medical communicators. other questions still remain: how do the various specialties of medical communicators best work together to optimize information dissemination? how do we manage and improve the flow of information in the public sphere to ensure accuracy? what can we, as medical communicators, do to elevate global health literacy and positively impact global health? how do we overcome negative societal perceptions and gain the trust of the patients we serve? the answers to these questions and others will shape the evolution of medical communication. the authors would like to acknowledge and thank charles mcnair, who contributed to the initial draft of this article. author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. author contact: suzanne_devandry@merck.com biosummaries joan affleck is an associate vice president at merck & co., inc, where she leads the medical writing department. throughout her 20 years in the pharmaceutical industry, her work has focused on solving information management challenges by learning from a variety of industries and developing novel approaches. following university studies in science and literature, joan moved to paris to edit a peer-reviewed international medical journal. after several years in publications, she shifted to the pharmaceutical industry. she has created and developed medical writing teams in north and south america, europe, and asia. joan holds an mba from columbia university, where she is a lang center innovation fellow and guest lecturer at colombia business school. she has served as an advisor to the http://www.amwajournal.org amwajournal.org 10the evolution of medical communication healthcare businesswomen’s association and transcelerate biopharma inc and is a member of the university of virginia darden school of business leadership communication council. in 2020, she received the president’s award from the american medical writers association. find ms affleck at merck sharp & dohme, llc, at joan.affleck@merck.com. dikran toroser is a senior director of project management in global scientific and medical publications at merck sharp & dohme, llc. he has a phd in biochemistry from newcastle upon tyne (uk). he did his post-doc at the cambridge lab (uk) on genetics and then moved to the us to work as a senior biochemist/researcher for the usda. dikran has been in publications since 2004, working at large pharmaceutical companies as publications lead and most recently at amgen and also takeda as a publications group lead. dikran has an extensive background in publication planning as well as medical writing. dikran is active in professional organizations (amwa, ismpp, acse) and is an author on guidelines for the publications profession (eg, amwa/emwa/ismpp joint position statement and “gpp4” [“gpp 2022”], the latest good publication practice guidelines for industry that was published in september 2022). he is one of the founding faculty for the uc san diego medical writing certificate and is a consulting director for the course. find dr toroser at merck sharp & dohme, llc, at dikran. toroser@merck.com. genevieve walker writes and edits patient education and consumer health materials in plain language. a medical communicator since 2002, she is a past president of the northwest amwa chapter, a new current member of the southwest chapter, and the leader of the amwa credit workshop writing and designing materials for patient education. dr walker is also an instructor in the university of chicago’s graham school medical writing & editing certificate program. dr walker holds a phd in english from the university of oregon. she has studied the principles of health literacy, readability, user-friendly design, and plain language since the mid-2000s. her background includes courses in adult instruction and linguistics. find dr walker at bridge health communications at genevieve@ bridgehealthcomm.com. to see her work, please visit www. bridgehealthcomm.com. amwa live webinars tools, tips, and tricks for medical communicators. www.amwa.org/events only $20 for members can’t attend a live webinar? you won’t miss out! all registrations for live webinars include access to the recorded video in amwa online learning. http://www.amwajournal.org http://www.bridgehealthcomm.com http://www.bridgehealthcomm.com v38 n2 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 5 abstract this year marks the 20-year anniversary of the good publication practice (gpp) guidelines, a set of principles and recommendations pertaining to peer-reviewed or peerorientated publications arising from research funded by or conducted in collaboration with industry sponsors. since the publication in the initial gpp guidelines in 2003, gpp guidelines have undergone several updates, with the latest iteration (gpp 2022 update) published in august 2022. the latest gpp guidelines built upon prior work and continue to strengthen principles and refine practices to reflect a rapidly evolving field of biomedical publishing. this article summarizes what is new in the latest gpp update and provide a quick document tour to help readers navigate the gpp 2022 document. in addition, a section from the perspective from medical writers and editors provides a preview of principles and practical guidance relevant to our day-to-day work. it is expected that further dissemination and discussion of the latest gpp 2022 update will continue to take place among publication professionals, medical writers, authors, journal editors and publishers, and other stakeholders, who share common goals of transparency, accountability, and quality of publications arising from company-sponsored biomedical research. the good publication practice (gpp) guidelines are a set of principles and recommendations pertaining to peer-reviewed or peer-orientated publications arising from research funded by or conducted in collaboration with industry sponsors, typically pharmaceutical, biotechnology, and medical device companies. this year marks the 20-year anniversary of the first gpp guidelines that were published in 2003.1 these initial gpp guidelines were developed to promote transparency and to establish standards for publication practice used by pharmaceutical companies. since then, gpp guidelines have undergone several updates to reflect changes within the publication field and to provide additional practical guidance on publication processes and procedures. these updates include the gpp22 published in 2009 and the gpp33 published in 2013. good practice for conference abstracts and presentations (gpcap)4 was published in 2019 to provide guidance specifically for congress abstract and presentations. the latest update of the gpp guidelines, the gpp 2022 update, was published in august 2022.5 to facilitate better tracking of updates, the current and future gpp updates will carry the date of the update (instead of a version number). table 1 summarizes gpp iterations published to date; all gpp guidelines are free to access by the public. an overview of the 2022 update of good publication practice (gpp) guidelines: a medical writer’s perspective qing zhou, phd, els / regeneron pharmaceuticals, inc, tarrytown, ny theme article table 1. gpp iterations gpp iteration year of publication citation gpp 2022 2022 detora lm, toroser d, sykes a, et al. good publication practice (gpp) guidelines for company-sponsored biomedical research: 2022 update. ann intern med. 2022;175(9):12981304. https://doi.org/10.7326/m221460 gpcap 2019 foster c, wager e, marchington j, et al. good practice for conference abstracts and presentations: gpcap. res integr peer rev. 2019;4:11. https://doi. org/10.1186/s41073-019-0070-x gpp3 2015 battisti wp, wager e, baltzer l, et al. good publication practice for communicating company-sponsored medical research: gpp3. ann intern med. 2015;163(6):461-464. https:// doi.org/10.7326/m15-028 gpp2 2009 graf c, battisti wp, bridges d, et al. good publication practice for communicating company-sponsored medical research: the gpp2 guidelines. bmj. 2009;339:b4330. https://doi. org/10.1136/bmj.b4330 original gpp 2003 wager e, field ea, grossman l. good publication practice for pharmaceutical companies. curr med res opin. 2003;19(3):149-154. https://doi.org/10.1185/ 030079903125001767 gpcap, good practice for conference abstracts and presentations; gpp, good publication practice. http://www.amwajournal.org https://www.acpjournals.org/doi/10.7326/m22-1460 https://www.acpjournals.org/doi/10.7326/m22-1460 https://researchintegrityjournal.biomedcentral.com/articles/10.1186/s41073-019-0070-x https://researchintegrityjournal.biomedcentral.com/articles/10.1186/s41073-019-0070-x https://www.acpjournals.org/doi/10.7326/m15-0288 https://www.acpjournals.org/doi/10.7326/m15-0288 https://www.bmj.com/content/339/bmj.b4330 https://www.bmj.com/content/339/bmj.b4330 https://www.tandfonline.com/doi/abs/10.1185/030079903125001767 https://www.tandfonline.com/doi/abs/10.1185/030079903125001767 amwajournal.org 6overview of the 2022 update of gpp guidelines one may wonder about the process for developing the gpp guidelines. as described in the methods sections of the gpp guidelines (gpp2 and onward),2-3,5 with support from the international society for medical publication professionals (ismpp), a steering committee was invited and formed, then members of the steering committee wrote the guidelines and managed review of the drafts by selected expert reviewers or a wider range of volunteers. the steering committees (typically also serving as the author groups) have consisted of experienced professionals representing various constituencies involved in publishing company-sponsored biomedical research. for example, in the latest gpp 2022 update, the author group represents different geographic regions (asia, europe, and north america) and includes members from pharmaceutical, biotechnology and device companies, medical communication agencies, journal editors and publishers, and academic institutions. it is worth noting that gpp guidelines identify best practices based on a wide range of existing guidelines. these include broader guidance on scholarly publishing by the international council of medical journal editors (icmje),6 various reporting standards such as consort7 and guidelines collected by the equator network,8 as well as ethical principles maintained by professional organizations such as american medical writers association (amwa),9 the european medical writers association (emwa),10 the ismpp,11 the council of science editors,12 and the world association of medical editors,13 to name a few. gpp guidelines are intended to be a living document that reflects current practice and will be subject to revisions as the field changes and expands. the sections below summarize what is new in the latest gpp update and provide a quick document tour to help readers navigate the gpp 2022 document. what is new in the gpp 2022 update many principles of prior gpp guidelines remain. the gpp 2022 update5 reflects the changes in the publication field as well as the expanding role of the publication professionals. the updated guidelines strengthen the core values of gpp such as ethics, transparency, inclusivity, accountability, and responsibility. the gpp 2022 update also includes a significantly expanded and reorganized supplement document, intended to provide more detailed guidance on day-today work in various process steps of publication planning, development, review, and approval. below is an overview of themes of changes and additions in the gpp 2022 update since the previous iteration (gpp3).3 for a detailed list of changes, the readers can refer to the table in the main body of the gpp 2022 update. • principles of gpp were augmented and strengthened.  gpp principles incorporate updated references to key ethical documents, such as icmje recommendations and the declaration of helsinki. the amwa-emwa-ismpp joint statement on the role of professional medical writers was also cited.  updated “ethical principles” include a total of 23 principles (compared with 10 principles in gpp3), divided into 5 areas: – general principles for ethics and good publication practice. – principles for protecting research and data integrity. – principles to promote transparency. – principles to support inclusivity. – principles for authorship, contributorship, and accountability.  “practical planning principles” were added to describe principles guiding practical aspects of work processes. • new topics were included to reflect changes and advances in the publication field.  gpp 2022 specifies a wider scope of research (eg, translational and biomarker studies, nonclinical research, health economics, real-world evidence, and outcomes research) and reflects advances of in biomedical publishing (eg, enhanced content, plain language summaries, preprints, and social media posting about peer-reviewed publications).  guidance is given regarding plain language summaries and enhanced content.  gpp 2022 recommends inclusivity in publication activities (eg, cultural differences and region-specific needs) and in people and teams involved in publications (eg, the composition of steering committees, author groups, and publication teams).  the guidelines also address the potential role of patients in publication activities. • the supplement was significantly expanded and reorganized.  in gpp 2022, the supplement was significantly expanded and reorganized to provide more detailed guidance on various publication process steps in a logical order (see the next section for more details). how to navigate the gpp 2022 update – a quick tour of the document the overall format of the gpp 2022 update5 is similar to that of gpp3;3 main principles are presented in the main body, and more detailed guidance and recommendations are http://www.amwajournal.org amwajournal.org 7overview of the 2022 update of gpp guidelines summarized in the supplement. the updated document, especially the supplement, contains a large amount of information. it may be hard to read the entire document in one sitting or to remember all the details. the summary below provides a quick tour of the document that may help readers to get familiar with the structure of gpp 2022 so they may locate relevant information more easily. • main body  “ethical principles” and “practical planning principles” are presented.  the main body also includes methods used for developing gpp 2022, the scope and format of gpp, how to use gpp, as well as conclusions and future directions.  a detailed table summarizes key changes and additions since the previous iteration.  specific sections in the supplement are called out in gpp principles in the main body to aid in quick cross referencing. • supplement  the expanded and reorganized supplement provides detailed guidance on various process steps, organized in sections a-i (summarized in table 2).  each section of the supplement may be used as a standalone document to help explain the process and best practices to publication stakeholders. the overall supplement can be used as a tool for publication team education and for guiding the development of publication policies and procedures at certain organizations. a perspective from medical writers and editors many medical writers and editors, whether employed by company sponsors, by medical communication agencies or contract research organizations, or are self-employed, are involved in the development of publications of company-sponsored biomedical research. medical writers, with professional expertise in scientific communication and in ethical publication principles, assist authors and sponsors to disclose and communicate research findings in an ethical, accurate, and timely manner. following on from gpp3,3 gpp 20225 continues to emphasize the professional roles of medical writers. a notable update is that under “general principles for ethics and good publication practice” in the main body text, it was made clear that medical writers should be treated ethically and enabled to follow ethical practice. table 2. summary of supplement sections a-i in the gpp 2022 update5 section topic content (section headings, titles of supplement tables and figures) a publication types primary and secondary publications reviews and meta-analyses scientific conferenced presentations other publication types enhanced content and plain lanuage summaries b publication professional roles and professional development professional roles professional development sharing best practices developing publications policies and procedures supplement table 1. team education: essential events and timing for clinical research publications c ethical principles: additional detail commitment to peer-reviewed publications publications as scientific exchange special considerations for communicating with the public additional significant considerations d publication steering committees responsibilities formation and ending membership charter meetings and communication supplement figure 1. suggested life cycle of a publicaiton steering committee e publication plans principles review and approval of publication plans supplement table 2. principles for publication plans supplement table 3. special considerations for the publication plan f publication working groups responsibilities initiation membership meetings and communication ending g authorship and contributorship determination principles author agreements additional considerations process supplement table 4. suggested author agreement contents h publication process journal and conference selection data sharing working with professional medical writers publication kick off publication draft review and approval acknowledgment, disclosures, and author statements journal submission, peer review, and page proofs post publication activities supplement table 6. relevant criteria for journal and conference selection supplement figure 2. overview of the publication process i documentation guidelines guidelines http://www.amwajournal.org amwajournal.org 8overview of the 2022 update of gpp guidelines in the gpp 2022 supplement, medical writers can also find relevant practical guidance on day-to-day work in several sections, including section b “publication professional roles and professional development,” section d “publication steering committees,” section f “publication working groups,” section g “authorship and contributorship determination,” and section h “publication process.”5 below are just a few examples of practical guidance relevant to medical writers: • roles of medical writers, along with roles of authors, other contributors, and reviewers, should be defined prospectively (supplement section d), and the employment of professional writing support should be agreed by authors (supplement section g). • medical writers, as with all publication contributors, qualify as authors if they meet authorship criteria (supplement section g). • medical writers should work under author direction. • medical writers should attend relevant meetings such as kick off or data dissemination meetings so they can capture authors’ views and directions (supplement sections f, h). • if they are not a byline author, a medical writer should not be asked to perform final data integrity check (supplement sections f, h) to help ensure adherence to icmje authorship criteria. • medical writing support needs to be disclosed. typically, the writer’s name, professional qualifications, affiliation, and funding source are disclosed at a minimum, along with any other information required by the journal or conference (supplement section h). • medical writers should engage in professional development and in sharing best practices (supplement section b). medical writers are highly encouraged to keep gpp guidelines on hand as a key reference and to consult them when questions or uncertainties arise at work. even if one may not find the exact answers for every work situation, the principles and processes described in the gpp guidelines may provide an approach for developing solutions. medical editors often work closely with medical writers to ensure that the publications are clear and concise, with a format and style suitable for the target audience, and meeting requirements by the journals, publishers, and scientific conferences. editors are often knowledgeable on topics related to journals and publishers (eg, journal styles, copyright requirements, and predatory publishing). their insights into language use can help make enhanced content and plain language summaries more effective for different audiences. for medical editors and those who work with medical editors, the detailed publication process described in the latest gpp guidelines can help identify where an editor’s insights and input are needed. for medical writers and editors, besides reading the published gpp document, there are other resources to learn about the latest gpp guidelines. for example, the ismpp held an ismpp u webinar “introducing gpp 2022” on september 21, 2022,14 and the emwa held a webinar “good publication practice 2022: focus on medical writing” on march 8, 2023.15 there are likely more discussions at various professional organizations on the latest gpp guidelines. conclusion since the publication in the initial gpp guidelines 20 years ago, gpp guidelines have undergone several updates, with the latest iteration (gpp 2022 update) published in august 2022.5 over the years, gpp guidelines have become a cornerstone of principles and standards for publications of company-sponsored biomedical research. the latest gpp guidelines built upon prior work and continue to strengthen principles and refine practices to reflect a rapidly evolving field of biomedical publishing. disseminating the newest gpp guidelines and incorporating them into day-to-day work requires continuous effort. it is expected that further dissemination and discussion of the latest gpp 2022 update will continue to take place among publication professionals, medical writers, authors, journal editors and publishers, and other stakeholders, who share common goals of transparency, accountability, and quality of publications arising from company-sponsored biomedical research. acknowledgments the author thanks lisa m. detora, phd, ms, dikran toroser, phd, and zoë preston, mphil, for providing critical review of this manuscript. author declaration and disclosures: the author notes no commercial conflict of interest in relation to this article. the views and opinions expressed in this article are those of the author and do not necessarily reflect the views of the author’s employer. author contact: qzhou.writer@gmail.com references 1. wager e, field ea, grossman l. good publication practice for pharmaceutical companies. curr med res opin. 2003;19(3):149-154. 2. graf c, battisti wp, bridges d, et al. research methods & reporting. good publication practice for communicating company sponsored medical research: the gpp2 guidelines. bmj. 2009;339:b4330. http://www.amwajournal.org amwajournal.org 9overview of the 2022 update of gpp guidelines 3. battisti wp, wager e, baltzer l, et al. good publication practice for communicating company-sponsored medical research: gpp3. ann intern med. 2015;163(6):461-464. 4. foster c, wager e, marchington j, et al. good practice for conference abstracts and presentations: gpcap. res integr peer rev. 2019;4:11. 5. detora lm, toroser d, sykes a, et al. good publication practice (gpp) guidelines for company-sponsored biomedical research: 2022 update. ann intern med. 2022;175(9):1298-1304. 6. international committee of medical journal editors. recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals. icmje. updated may 2022. accessed february 26, 2023. www.icmje.org/ recommendations. 7. schulz kf, altman dg, moher d; consort group. consort 2010 statement: updated guidelines for reporting parallel group randomized trials. ann intern med. 2010;152(11):726-732. 8. equator network. accessed february 26, 2023. www.equatornetwork.org. 9. american medical writers association website. accessed february 26, 2023. www.amwa.org. 10. european medical writers association. accessed february 26, 2023. www.emwa.org. 11. the international society for medical publication professionals. accessed february 26, 2023. www.ismpp.org. 12. council of science editors. accessed february 26, 2023. www. councilscienceeditors.org. 13. world association of medical editors. accessed february 26, 2023. www.wame.org. 14. detora lm, dormer l, diblasi f, plunkett f. ismpp u introducing gpp 2022. international society for medical publication professionals webinar. september 21, 2022. accessed february 26, 2023. https://www.pathlms.com/ismpp/ courses/37863/webinars/31490 15. detora lm, plunkett f, preston z. good publication practice 2022: focus on medical writing. emwa webinar. march 8, 2023. https:// www.emwa.org/education/emwa-webinars-programme-2023/ www.amwa.org/mwc three little letters. one big deal. apply now apply by october 17 for december 2023 exam. review our applicant handbook, candidate guide, and study tips to help you prepare. http://www.amwajournal.org http://www.icmje.org/recommendations http://www.icmje.org/recommendations http://www.equator-network.org http://www.equator-network.org http://www.amwa.org http://www.emwa.org http://www.ismpp.org http://www.councilscienceeditors.org http://www.councilscienceeditors.org http://www.wame.org https://www.pathlms.com/ismpp/courses/37863/webinars/31490 https://www.pathlms.com/ismpp/courses/37863/webinars/31490 https://www.emwa.org/education/emwa-webinars-programme-2023/ https://www.emwa.org/education/emwa-webinars-programme-2023/ v38 n2 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 13 monica nicosia, phd / nicosia medical writer llc, bryn mawr, pa a medical writer’s guide: working on clinical research manuscripts for submission to peer-reviewed medical journals theme article abstract prompt publication of clinical trial results in peer-reviewed journals is essential to advance clinical practice and improve patient outcomes. the involvement of professional medical writers (pmws) in the preparation of these clinical research manuscripts can enhance their quality and shorten publication timelines. research manuscript projects can be daunting, especially for early-career pmws who could benefit from insights provided by experienced pmws. in this guide, first i share my perspective on how pmws contribute to such projects and the essential skills and competencies we should provide. then, i describe my tactical approaches to initiating these projects, developing the first draft of a detailed outline or manuscript, and avoiding some common pitfalls that can undermine the quality of a manuscript. finally, i share some tips for working with challenging personalities. there are many types of biomedical research manuscripts (figure 1).1 research manuscripts that report the results of clinical investigational studies are among the most impactful articles published in peer-reviewed biomedical journals. prompt publication of clinical trial results is essential to facilitate discussion of their implications for clinical practice and any potential improvements in patient outcomes. however, because clinical investigators need to balance clinical, research, and other responsibilities, they usually have limited time to prepare manuscripts for journal submission. their junior medical colleagues often have even less time and less training in writing scientific manuscripts. the involvement of professional medical writers (pmws) in the preparation of research manuscripts can improve their quality and shorten publication timelines.2-4 in this context, pmws lay the groundwork for building a submission-ready manuscript like specialist nurses or physician assistants do for physicians treating patients. for early-career pmws, working on research manuscript projects can be a daunting challenge. in this guide, i share my perspective on the role of pmws in such projects, our key functions and responsibilities, and tactics and tips that have helped me excel at these projects. how medical writers contribute to research manuscript projects in collaboration with the lead clinical investigators/authors and under their guidance, pmws can contribute to various aspects of manuscript preparation (figure 2, next page). as a freelance pmw, i have sometimes been asked to prepare only a partial or complete first draft. other times, i have supported research manuscript projects from conception and through various revisions, until readiness for journal submission. occasionally, i have been tasked with revising the work of others for submission to a different journal. the work of pmws on research manuscript projects must reflect guidance provided by professional ethics,5-8 standards for best practice,9-13 applicable health research reporting guidelines,14 and journal-specific instructions for authors (figure 3, next page). in light of this guidance, my main goal as a pmw is to produce a succinct, clear, well-organized, and accurate draft document that reports the results of a study and the authors’ interpretation while adhering to the guidelines for the target journal. by producing a high-quality, data-supported work, i maximize the chances that the figure 1. types of biomedical research manuscripts. research manuscripts preclinical studies clinical trials case-control studies cohort studies systematic literature reviews and meta-analysescase seriescase reports epidemiological studies surveys costeffectiveness analyses genetic and genomic studies healthcare outcomes research http://www.amwajournal.org amwajournal.org 14working on clinical research manuscripts for peer-reviewed medical journals manuscript will be accepted for publication and minimize the work required of others (eg, authors, editors, other collaborators, colleagues). as a pmw of a research manuscript, i am usually not considered an author because my contributions do not meet all 4 of the international committee of medical journal editors (icmje) criteria for authorship (figure 4).9 per icmje standards, journal guidelines, and other best practices, manuscripts must acknowledge the contributions of pmws and medical editors along with the source of funding for their work. clinical trial results protocol interim or final analysis of data compiled in: •tabulated data (eg, tlf, spreadsheets) •csr or other study report •partial analysis •oral or poster presentation manuscript conception meetings and communications with authors, biostatistician, pmw, other team members to discuss: •main objectives of publication •key data, figures, tables •target journal •authorship •timeline first draft (detailed outline or manuscript) literature research edit, write, reference, annotate data-check and fact-check format per journal requirements query regarding missing data and other issues revise and finalize draft track versions compile comments incorporate author edits and comments query regarding unclear comments edit and format prepare for submission to target journal journal submission and review editorial review peer review decision journal decision accept with no caveats reject revise in response to reviewers' comments with conditional acceptance or option to resubmit professional medical writer (pmw) authors figure 2. how a pmw might contribute to the preparation of a clinical trial research report for submission to a peer-reviewed journal. ethics amwa emwa ismpp standards for best practice icmje gpp cse health research reporting guidelines equator network • consort (randomized trials) • strobe (observational studies) • prisma (systematic reviews) • squire (quality improvement studies) • many more journalspecific instructions for authors editorial policies guidance for specific types of articles manuscript preparation and submission requirements figure 3. key sources of guidance for pmws working on research manuscripts. amwa, american medical writers association; cse, council of science editors; emwa, european medical writers association; gpp, good publication practice; icmje, international committee of medical journal editors; ismpp, international society for medical publication professionals; pmw, professional medical writer. figure 4. how icmje authorship criteria usually apply to pmws working on research manuscripts. substantial contribution to work conception or design data acquisition, analysis or interpretation content of work draft work or critically revise it for important intellectual content approval of work approval of final version for publication accountability for work agree to be accountable for all aspects of work to ensure appropriate investigation and resolution of any accuracy or integrity questions author pmw http://www.amwajournal.org amwajournal.org 15working on clinical research manuscripts for peer-reviewed medical journals essential skills and competencies for working on research manuscripts pmws must have a variety of skills and high-level competencies (figure 5). it is not a hobby that can be casually picked up—it’s a profession. for example, being considered a good writer as an undergraduate, earning a doctorate in a life science field, doing postdoctoral research, and being an author of several nonclinical research manuscripts did not automatically make me a good medical writer. i was fortunate to be hired as an entry-level medical writer at a medical communication company. while there, i developed my medical writing and editing skills through amwa workshops and seminars, diligent practice, reading good medical writing, and receiving constructive criticism and feedback from medical editors and other experienced colleagues. when i started my own freelance business, i continued to expand these skills by always striving to improve. interpersonal skills • communications and tact • team player • attention to detail • time management • organization • logical and analytical thinking • problem-solving and creativity writing and editing skills • grammar and usage • sentence structure • spelling • punctuation • planning and outlining medical writing knowledge and skills • manuscript construction • medical terminology and concepts • data and statistics • literature research • ama manual of style • journal requirements • annotation • art of query software skills • word processing • create and manipulate tables and graphs • online research • reference management professional ethics and best practices • familiarity and applicability • understand responsibilities • make good decisions table 1. selected recommendations for good medical writing of research manuscripts reporting clinical trial results topic applicable statements from ama manual of style 11th edition my recommendations active voice versus passive voice “in general, authors should use the active voice, except in instances in which the actor is unknown or the interest focuses on what is acted on …”1,a “if the actor is mentioned in the sentence, the active voice is preferred over the passive voice.”1,a use a judicious mixture of active voice and passive voice. active voice makes the writing clearer and more concise. it also emphasizes the authors’ ownership of their work. too much passive voice makes the writing boring and verbose, causing the reader to lose interest. patient or participant instead of subject or case “some consider subject (as in study subject) to be impersonal, even derogatory, as if the person in the study were in a subservient role. similarly, the use of case is dehumanizing when referring to a specific person.”1,b use the term patient if the study participant is being treated for a medical condition. use the term participant or volunteer if the study participant is healthy and/or is not being treated. keep in mind that the study participants or their loved ones might read the publication. we must show respect for their personhood and contributions. sex and gender use sex-neutral terms when applicable. for example:1,c • chair or chairperson instead of chairman or chairwoman • layperson instead of layman • humankind instead of mankind “when reporting the sex of participants in a table, include both sexes, as identified in the study, regardless of the ratio. do not use “white” and “male” as the default.”1,d report data on sex and gender in an equitable, inclusive, and consistent manner. don’t report only the data for the majority group. when sex/gender is irrelevant, reword the sentence to use they as singular or plural. this is an evolving area; read on the topic,15,16 attend an amwa talk about it, and research the latest trends. race and ethnicity “… be sensitive to the designations that individuals or groups prefer. be aware also that preferences may change and that individuals within a group may disagree about the most appropriate designation.”1,e report data on race and ethnicity in an equitable, inclusive, and consistent manner. don’t report only the data for the majority group. be as specific as possible when reporting data by race and ethnicity (eg, include definition of “other” category). terms for people with conditions, disorders, or diseases “avoid labeling (and thus equating) people with their disabilities, or diseases (eg, the blind, schizophrenics, epileptics). instead, put the person first.”1,f “avoid describing persons as victims or with other emotional terms that suggest helplessness.”1,f some of my preferred phrasing: • patient with cancer instead of cancer patient or cancer victim • people with obesity instead of the obese • persons (or people) with covid-19 instead of covid-19 patients (or cases) • older patients (or patients ≥ 65 years of age) instead of the elderly apage 431, bpage 513, cpages 543-544, dpage 544, epage 546, fpage 547. mastering the craft of medical writing is key to successfully completing a research manuscript project. the ama manual of style1 is an important resource for pmws who work on manuscripts for submission to american medical journals. most of these journals base their style and format on the ama manual. when i work on a manuscript for submission to a peer-reviewed journal, i apply the ama manual guidance (for examples, see table 1) along with guidance provided by the journal’s figure 5. essential knowledge and skills for medical writers working on research manuscript projects. http://www.amwajournal.org amwajournal.org 16working on clinical research manuscripts for peer-reviewed medical journals manuscript preparation instructions. doing so improves the consistency and clarity of my work and helps me educate other collaborators (eg, authors, clients, colleagues) on best practices in medical writing. how to get started on a clinical research manuscript project as i work on these manuscripts, i am especially cognizant of the second principle from the amwa code of ethics, which states that “medical communicators should apply objectivity, scientific accuracy and rigor, and fair balance while conveying pertinent information in all media.”5 as pmws, we must keep this principle at the forefront when we synthesize information and data from various sources (figure 6) to produce cogent and accurate drafts for authors to develop. once i receive a research manuscript assignment, i take several steps to ensure that i start the project efficiently (table 2). first, i review and organize the provided assignment document(s), background information, and other materials. as a freelancer who is usually not bound to a company’s internal processes, i have developed my own system of 5 main electronic folders (named background, communications, paperwork, references, text), each labeled with a client and project code. i make sure that i understand the project specifications, the team’s roles and figure 6. examples of information and data sources for the major sections of a clinical research manuscript. notes from authors can come from meetings, emails, and phone calls. csr, clinical study report; tlf, tables, listings, and figures. • text and notes from authors • outline (simple or detailed) • protocol • csr or other study report • provided references and research • text and notes from authors • protocol • statistical analysis plan • csr or other study report • text and notes from authors • csr or other study report • tlf or other tables and figures • slides and poster presentations • excel files of data, figures, tables introduction and discussion methods results examples of sources major sections table 2. key steps and tips for starting a manuscript project for submission to a medical journal step tips 1. study and organize materials, and keep them organized. • organize project materials into standardized electronic folders. • keep emails and notes of kick-off and follow-up phone conversations and live/online meetings (start and maintain a paper trail to document everything). 2. determine what else is needed, keep notes on the project, and proactively communicate issues. • take notes regarding project-related questions and issues that arise.  if issues can’t be resolved by digging deeper in material, send queries via emails to a key contact.  keep track of queries and responses (eg, save emails in project subfolder). 3. review author manuscript preparation instructions for target journal. • find examples of recent articles from journal. • take notes on requirements and stylistic preferences:  word counts for abstract and main text.  limits for numbers of tables, figures, and references.  types of headings.  data format (eg, p values, significant digits). 4. set up word manuscript file. • follow the author manuscript guidelines for the target journal. • modify the heading styles to outline and organize your draft. • include a statement acknowledging contributions as a medical writer/editor and the source of funding for this work. • use the quick access toolbar, keyboard shortcuts, navigation pane, and split screen option (view panel) to work efficiently. 5. set up reference management library (eg, endnote). • import citations from pubmed, other databases, and journal websites. • if needed, correct endnote style to match current format used by journal. 6. use easy and consistent naming formats for reference pdfs. • my preference: first author’s last name, journal abbreviation, year of publication (eg, smith et al j clin oncol 2023) • don’t name files by their title (it’s too long, and that’s not how papers are cited) but do consider including a short phrase summarizing the title (eg, smith et al j clin oncol 2023 [phase 3 drugx melanoma]). 7. use a file naming system that promotes version control • name files in a consistent manner (eg, “smith phase2 ms d1.0”). • have reviewers add initials when they send in their comments or rename the file yourself when you receive it (eg, “smith phase2 ms d1.0_mn”). pdf, portable document format. http://www.amwajournal.org amwajournal.org 17working on clinical research manuscripts for peer-reviewed medical journals responsibilities, the format for required deliverable (eg, outline, manuscript), and the timeline. when i work with a new group, i also need to confirm the lines of communication (eg, who will answer queries, who will provide portable document format (pdf) files for reference articles). second, i identify what else i need to start the project and decide on my next steps (eg, what questions to ask; what to research). typically, the initial questions i need answered are: • what sources of materials (eg, protocol, study report, key references) do i have to write and/or revise the draft? • what is the target journal? • what is the deadline for my first deliverable? • does the client want me to highlight sources and annotate the first draft? if yes, do they require a specific format? • which, if any, reference management software may i use? third, i study the journal’s manuscript preparation instructions. to help structure and format the manuscript, i find 2 or 3 studies published in the target journal that are similar to the one that i am working on. i also try to find a few recent publications by the lead author(s) to get a general idea of their writing style. fourth, i set up the word document. unless a client requires me to use their template, i structure my word manuscript to comply with the manuscript preparation instructions. i like to modify the style headings to help me outline and navigate the draft. fifth, i set up a reference management library for the project. i use endnote. other options include mendeley and zotero. a reference management software program is an essential time-saving tool for pmws to manage references, create citations, and generate reference lists that conform to the target journal style. sixth, i use a consistent naming format for my reference pdfs so that i can easily access the correct reference as i develop a draft outline or manuscript. i used to print reference articles and other key sources, but i no longer do that. i work from the pdfs, keeping them side by side with my draft and highlighting and annotating as i go. seventh, i use a simple file naming system that promotes version control to minimize confusion during reviews. of course, sometimes the lead author or client renames files using their own system. i stick with what they decide and keep detailed notes to keep track of versions and author responses. how to develop the first draft of a clinical research manuscript similar to the approach recommended by other pmws,17 i start by drafting the methods and/or results, which are the most straightforward sections of a typical clinical research manuscript (figure 7). this approach helps me familiarize myself with the study and avoid writer’s block. sometimes, perhaps because a section is tedious, i alternate working on different sections. clinical trials tend to have similarly organized methods section, unlike in vivo and in vitro experimental studies which have varied methodologies even within the same research area. figure 7. sequential approach to building a research manuscript reporting clinical trial results. after i have drafted the methods and results sections, i work on the introduction and sketch out a discussion for the authors to modify and expand. the abstract is usually the last section i work on because i tend to build it by cutting and pasting key sentences from the main sections and then editing the text to fit the required word count. once, a lead author asked that i start with the abstract to help him organize his thoughts at the onset of the manuscript. luckily, i only had to update and edit an abstract that the authors had presented at a conference. as i research and write the first draft of a detailed outline or manuscript, i highlight references and annotate corresponding pdfs (figure 8). in comment boxes or within brackets in the text, i include notes and queries regarding any potential issues (eg, missing or unclear methods, inconsistent use of terms) (figure 9). i also compile small batches of queries that require prompt attention because they impact how i proceed in my work and email them. it’s important to resolve issues sooner rather than later. i absolutely do not want to submit a draft peppered with queries that should have already been resolved. methods •study design •trial oversight •patient recruitment and eligibility criteria •objectives/endpoints •assessments •statistical analysis figures and tables •patient disposition flow diagram (consort) •baseline characteristics table •efficacy table(s) and/or figure(s) •safety table(s) results •patient disposition •patient baseline characteristics •summarize efficacy •summarize safety and tolerability introduction •highlights of disease problem •intervention background •rationale for trial •purpose of trial discussion •study design and key results •results in context of literature and clinical practice •limitations •future directions •conclusions abstract •background •methods •results •conclusions track the word count http://www.amwajournal.org amwajournal.org 18working on clinical research manuscripts for peer-reviewed medical journals throughout this work, i keep track of the word count (which for some journals can be quite stingy). before i send any draft for review, i make sure to update the word counts for both the main text and the abstract. one of the tasks we have as pmws is to help the authors comply with the word count requirements. this can be challenging during the draft revision process. when authors exceed the word count limit, i suggest edits in track changes to retain the meaning while reducing verbiage. sometimes, i suggest that they move certain sections to an online supplement. how to avoid common pitfalls common pitfalls of writing research manuscripts include accidentally plagiarizing published information and/or repurposing unpublished content; perpetuating inaccurate content; inserting erroneous data; creating a disorganized, inconsistent manuscript structure; and introducing typos, spelling mistakes, and poor grammar (figure 10). most of these errors are unintentional and are caused by taking shortcuts. i employ several tactics to avoid these pitfalls. if medical editors are on the project team, they will also check for these issues, but they might not be involved until later, and we should give them and the authors a well-written and organized draft to work on. cite and paraphrase content because plagiarism is unethical and infringes on intellectual property rights, pmws should know how to paraphrase figure 8. examples of reference annotation formats. figure 9. tips and examples of in-text and email queries. format minimal first author, journal, year, page(s), column, section first author, journal, year, page(s), column, paragraph or line number example first author, journal, year, page(s) detail level moderate high tips query in text example • concise and polite • clearly marked to distinguish them from notes or annotations • if specific to a person, include name in query • provide specific suggestions whenever possible format email • succinct, organized, and polite • use bulleted lists • identify the relevant section of manuscript • make it easy to read and reply http://www.amwajournal.org amwajournal.org 19working on clinical research manuscripts for peer-reviewed medical journals content and properly cite its sources. we should not succumb to the temptation of copying text from study protocols, clinical study reports (csrs), and other unpublished documents. the writing style of such documents is often unsuitable for a journal article because it may be passive, formulaic, and verbose. it’s better to paraphrase the material, pay attention to active and passive voice, and avoid using archaic terms like subject and caucasian. i am also cautious about copying whole or parts of tables across files because disruptive formatting codes might transfer to the manuscript. i would not use any content generated by an artificial intelligence program like chatgpt. several leading journals have published editorials discussing this controversial, still evolving technology and limiting or prohibiting its use in manuscripts submitted for publication.18-21 verify data and facts another common pitfall in writing clinical research manuscripts is incorporating data and information cited in other documents (eg, protocols, csrs, published articles) without factchecking the accuracy of each citation. i check the cited reference (often using the pdf search field to quickly find specific numbers or terms) to determine if it does indeed provide the information. also, when the cited information is older than 1 to 2 years (depending on the field’s pace of research), i do literature searches to identify more recently published sources. this is especially important for rapidly advancing fields like oncology in which, for example, the american cancer society publishes new statistics every year. even when not required by project specifications, i highlight references and annotate the detailed outline or first draft of a manuscript to keep a record of the sources of any included information and data. this documentation step does not take long, and it saves time and headache during the review/revision process in addressing questions regarding data accuracy, conflicting information, and other issues that might be raised by authors and other project participants. i have noticed, when factchecking others’ work, that some writers cite a published research manuscript as the source of information referred to in the introduction or discussion sections of the cited publication. this is a misleading use of a citation. for example, the introduction section of a hypothetical phase 2 study by smith et al on a new adjuvant drug for people with resectable pancreatic cancer mentions a range of reported median progression-free survival (pfs), citing 3 sources. instead of taking the shortcut of inaccurately citing the smith et al study in my manuscript, i would cite the primary sources for the pfs data or a reputable review. i would cite the smith et al paper if i were discussing the results or conclusions of their study. avoid inserting numerical errors the compilation of data in tables and figures is one of most tedious tasks of a research manuscript project. it’s challenging to keep track of and accurately copy numbers from large tables that were prepared for csrs, tables, listings and figures (tlfs), and other study reports. these are the steps i take to avoid losing track as i copy numbers: • place documents next to each other on a large screen. figure 10. common pitfalls and how to avoid them. manuscript quality plagiarize and/or repurpose content perpetuate inaccurate data and facts insert erroneous data create a disorganized inconsistent structure introduce typos and other mistakes prevention: • fact-check • research prevention: • paraphrase • cite prevention: • proofread prevention: • check for consistency • keep parallel structure prevention: • carefully copy data • perform quality control checks http://www.amwajournal.org amwajournal.org 20working on clinical research manuscripts for peer-reviewed medical journals • enlarge source and recipient documents. • copy (cut/paste or retype) and round (if necessary) small batches of numbers at one time. • after copying the numbers, highlight the data in the source document (to mark my place). • every 2 to 3 rows of copied numbers, backtrack and double-check the values to correct any typos. the data in tables from csrs, ltfs, and other statistical/ mathematical outputs can be difficult to read because of the multiple digits to the right of the decimal (eg, 45.567% vs 45.6% or 46%). often these digits are not scientifically significant, especially when they were generated to calculate percentages or mean/medians. as noted in the 11th edition of the ama manual of style1(p1010), “when numbers are expressed in scientific and biomedical articles, they should reflect the degree of accuracy of the original measurement. numbers obtained from mathematical calculations should be rounded to reflect the original degree of precision.” the ama manual has a helpful section summarizing rounding rules.1(p1011) in addition to being scientifically accurate, rounded numbers are easier to read. however, before doing any rounding, it’s important to verify with the authors how many significant digits they would like to use throughout their manuscript. create an organized consistent manuscript to create a well-organized and easy to read manuscript, pmws must ensure the consistent use of terms, abbreviations, and data across the different sections of the manuscript (ie, abstract, main text, tables, figures, online materials). for example, the definition of an outcome measure described in the methods and results sections should match the definition used in a table. for numerical data, inconsistencies might especially occur whereby numbers are rounded in one section of the manuscript (eg, the results text) but not in another (eg, a table, figure, or abstract). i use the word split screen option (window submenu in the view bar) to help me verify that numerical data are reported in the same way across sections. we should also use parallel structure in subheadings, paragraphs, and sentences that are discussing similar information. for example, the presentation of information in the methods section should match the sequence and content of data discussed in the results section. although some of these tactics may appear subtle, together they improve manuscript clarity and maintain reader’s interest. proofread your drafts as i work on a draft in word, i turn on the spelling and grammar checker under the proofing submenu of the review tab. despite this and careful writing, errors slip through. thus, even if other people will review my work, i proofread it before sending any draft to the next step in the process. the point of proofreading is to catch and correct any mechanical errors, not to second-guess myself and rewrite. it’s challenging to proofread your own work because when you are immersed in writing a draft, your eyes tend to skim over words they have seen repeatedly, allowing errors to become invisible. to reset and refresh my eyes and brain after i finish a draft, i wait for several hours or, preferably, until the next morning before proofreading it. i proofread on screen, zooming in to enlarge text 15% to 25% of my normal writing mode. early in my writing career, i proofread printed drafts. i switched to working onscreen years ago because it works well for me and reduces paper waste. other tips for proofreading onscreen include changing the background color, reading text aloud, and pointing at words as you read them. an interesting tactic hope lafferty, els, spoke about during her excellent amwa 2022 annual conference education session entitled “editing your own work (after you’ve read it 1,000 times)” is to read text backwards, word by word or sentence by sentence. tips for working with challenging personalities some authors and clients are easy to work with in a collaborative manner. others might pose challenges. for example, they could be unresponsive, set in their ways, condescending, overly demanding, and inexperienced. regardless, as pmws we have to remember that the authors have the final say and responsibility for the content of their manuscript. we can offer suggestions and provide education, but all final decisions are theirs. patience and tact are essential for working with challenging individuals. for example, when i must respond to an irritating email, i draft a response and then step away from it for at least several hours before editing (usually to tone it down) and clicking send. sometimes it might help to discuss the matter with a trusted colleague before further communicating with the difficult person. during a project, i routinely keep all my emails in an organized fashion so that i can verify prior responses (keeping that paper trail documentation mentioned earlier). this is especially helpful when someone tells me to do one thing one week and something completely different a week later, doesn’t respond to several polite emails asking for clarification or further instructions, or demands their draft earlier than agreed. other tactics for working with different personalities include: http://www.amwajournal.org amwajournal.org 21working on clinical research manuscripts for peer-reviewed medical journals • be clear, concise, and tactful in all forms of communication (ie, email, queries in the drafts, voicemail). • suggest concrete solutions for issues regarding their writing—for example, instead of saying that text is unclear, i reword it into what i think it means and ask the authors if my edited version is correct. • use information from the ama manual of style, journal author guidelines, and examples from articles published in the same journal or in more prestigious journals to educate about formatting and style decisions you implemented in a manuscript—for example, sometimes authors spend their valuable manuscript-review time to change “ie or eg” to “i.e. or e.g.” they don’t understand that i purposely used the unpunctuated abbreviations to follow the journal style (even though i noted on the first page that the manuscript is formatted per a specific journal). in these cases, i don’t accept the author changes and explain my rationale, citing the appropriate style manual or manuscript preparation instructions. • try alternative ways of communication—some people who don’t respond to emails might be reachable through a phone call or by first speaking with their administrative assistant or another member of the project team. online meetings to share the screen and do edits live might work well for authors who never find the time to review drafts and send their comments via track changes. final words being a pmw is rewarding and humbling. we should take pride in the ways we contribute to the clear and timely publication of research findings. it is gratifying to hear from authors how much they appreciate our work. however, we also have to accept feedback and corrections from editors, authors, and other stakeholders involved in the project. when we make mistakes, we should take responsibility, apologize, and learn. these actions help us grow as professionals and maintain good working relationships with authors, clients, supervisors, and colleagues. regardless of whether a pmw works on research manuscripts or other types of projects, practice and ongoing learning are critical for success. to keep up with progress in our profession and in the therapeutic areas we work on, pmws must continue to broaden our knowledge base and skill sets throughout our careers. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: monica@nicosiamedicalwriter.com references 1. christiansen sl, iverson c, flanagin a, et al. ama manual of style: a guide for authors and editors. 11th ed. oxford university press; 2020. 2. evuarherhe o, gattrell w, white r, winchester cc. professional medical writing support and the quality, ethics and timeliness of clinical trial reporting: a systematic review. res integr peer rev. 2019;4:14. 3. gattrell wt, hopewell s, young k, et al. professional medical writing support and the quality of randomised controlled trial reporting: a cross-sectional study. bmj open. 2016;6(2):e010329. 4. hamilton cw, gertel a, jacobs a, marchington j, weaver s, woolley k. mythbusting medical writing: goodbye, ghosts! hello, help! account res. 2016;23(3):178-194. 5. amwa code of ethics. amwa. published 2008. accessed february 6, 2023. https://www.amwa.org/general/custom.asp?page=code_of_ ethics 6. jacobs a, wager e. european medical writers association (emwa) guidelines on the role of medical writers in developing peer-reviewed publications. curr med res opin. 2005;21(2):317-322. 7. amwa–emwa–ismpp joint position statement on the role of professional medical writers. amwa, emwa, ismpp; 2017. accessed february 8, 2023. https://cdn.ymaws.com/www.amwa.org/resource/ resmgr/about_amwa/jointpositionstatement.profe.pdf 8. ismpp. code of ethics for medical research publication principles for publication professionals. ismpp. updated january 29, 2019. accessed february 6, 2023. https://www.ismpp.org/ethics 9. icmje. defining the role of authors and contributors.icmje. published 2023. accessed february 6, 2023. https://www.icmje.org/ recommendations/browse/roles-and-responsibilities/defining-therole-of-authors-and-contributors.html 10. battisti wp, wager e, baltzer l, et al. good publication practice for communicating company-sponsored medical research: gpp3. ann intern med. 2015;163(6):461-464. 11. detora lm, toroser d, sykes a, et al. good publication practice (gpp) guidelines for company-sponsored biomedical research: 2022 update. ann intern med. 2022;175(9):1298-1304. 12. council of science editors. recommendations for promoting integrity in scientific journal publications. cse. published 2022. accessed february 8, 2023. https://www.councilscienceeditors.org/ recommendations-for-promoting-integrity-in-scientific-journalpublications13. editorial policy committee, council of science editors. cse's white paper on promoting integrity in scientific journal publications. cse; 2021. accessed february 8, 2023. https://cse.memberclicks.net/ assets/docs/2023/cse-white-paper_feb2022_webpdf.pdf 14. enhancing the quality and transparency of health research. equator network. published 2023. accessed february 8, 2023. https://www.equator-network.org/ 15. heidari s, babor tf, de castro p, tort s, curno m. sex and gender equity in research: rationale for the sager guidelines and recommended use. res integr peer rev. 2016;1:2. 16. nahmias j, zakrison tl, haut er, et al. call to action on the categorization of sex, gender, race, and ethnicity in surgical research. j am coll surg. 2021;233(2):316-319. 17. gerstein hc, sherifali d, satia i. writing your paper from the middle. amwa j. 2022;37(2):19-20. 18. tools such as chatgpt threaten transparent science; here are our ground rules for their use. nature. 2023;613(7945):612. 19. stokel-walker c. chatgpt listed as author on research papers: many scientists disapprove. nature. 2023;613(7945):620-621. 20. thorp hh. chatgpt is fun, but not an author. science. 2023;379(6630):313. 21. flanagin a, bibbins-domingo k, berkwits m, christiansen sl. nonhuman “authors” and implications for the integrity of scientific publication and medical knowledge. jama. 2023;329(8):637-639. http://www.amwajournal.org https://www.amwa.org/general/custom.asp?page=code_of_ethics https://www.amwa.org/general/custom.asp?page=code_of_ethics https://cdn.ymaws.com/www.amwa.org/resource/resmgr/about_amwa/jointpositionstatement.profe.pdf https://cdn.ymaws.com/www.amwa.org/resource/resmgr/about_amwa/jointpositionstatement.profe.pdf https://www.ismpp.org/ethics https://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html https://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html https://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html https://www.councilscienceeditors.org/recommendations-for-promoting-integrity-in-scientific-journal-publicationshttps://www.councilscienceeditors.org/recommendations-for-promoting-integrity-in-scientific-journal-publicationshttps://www.councilscienceeditors.org/recommendations-for-promoting-integrity-in-scientific-journal-publicationshttps://cse.memberclicks.net/assets/docs/2023/cse-white-paper_feb2022_webpdf.pdf https://cse.memberclicks.net/assets/docs/2023/cse-white-paper_feb2022_webpdf.pdf https://www.equator-network.org/ amwajournal.org 57jam session for earlyto mid-career freelancers author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: kfeemster@greenfirecompany.com jam session for earlyto mid-career freelancers session moderator jennifer minarcik, ms / principal, jennifer minarcik biomedical communications, llc, moorestown, nj by suzanne morris, dvm, mwc about 15 freelancers and freelancers-to-be gathered at the amwa 2022 southeast regional conference in june to share their early freelance career experiences. some of the participants had just decided to take the freelance plunge and were eager for tips on setting up a new business whereas others with more experience were wanting to share lessons learned. session facilitator jennifer minarcik, ms, started the discussion by divulging some of the assumptions she had when she first started her freelancing career. she spoke to the misperception that freelance medical writers are all in competition with each other by pointing out the diversity of medical writing genres represented by the session’s participants. acknowledging that the varied nature of freelance medical writing lends to camaraderie rather than competitiveness among freelance medical writers led to a discussion of networking. although making connections with other freelancers may not translate to immediate work, networking can develop leads, elevate a freelancer’s marketplace presence, and unearth other benefits. one of the more valuable of these benefits may be finding a good mentor. the more experienced session participants extolled the benefits of mentorship in guiding their early freelancing careers. but how does a new freelancer go about finding a mentor? those who had who have benefitted from mentorship described a relationship which naturally developed from a networking connection. another early career misstep minarcik discussed was the compulsion to take on every project, and the consequent erosion of the work-personal life border. minarcik and the other more seasoned freelancers agreed that project selectivity fosters a reasonable work schedule and, potentially, better clients. because part of cultivating a work-life balance entails supporting work hour productivity, the discussion then turned to productivity strategies. for example, creating a schedule with built-in time to respond to distractions like emails supports productivity during work hours. protecting work time also may require establishing boundaries with clients by responding to clients only during set work hours or at set times during the week. the conversation turned to some of the other nuts-andbolts of running a freelance business. as with most freelance medical writing discussions, the topic of contracts arose, albeit briefly. the take-home message for new freelancers was to carefully review contracts, particularly with respect to payment parameters. some of the freelancer participants who were just forming their businesses asked for advice on insurance and accounting. the responses from the more seasoned participants were mixed—few had insurance, and several used accounting services and software. but the consensus was that some form of accounting assistance was very helpful. inevitably, the discussion turned to what may be the most daunting aspect of freelance medical writing or freelancing in general: marketing. the importance of presence online, particularly on platforms like linkedin, was discussed at length by several seasoned freelancers. for introverts averse to overt self-promotion, a less intimidating approach may be simply posting about topics of interest, which creates an online presence and can garner attention. another strategy was to investigate companies associated with relevant forms of medical writing on linkedin and make connections with their employees. whether to solicit potential clients through email was a point of debate, with the more experienced freelancers advising that if done, it should be targeted and could backfire by annoying the targeted client. the discussion of marketing repeatedly circled back to value of networking, which can be done online and in person through, for example, amwa events. and in keeping with its overriding theme, this amwa session ended with participants exchanging their business cards. suzanne morris is the owner of concrete medical writing, llc, in st. petersburg, fl. author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. author contact: suzanne@concretemedicalwriting.com public relations in medical communication speaker katrina r. burton, bs / public relations program director by lisa kuhns, phd according to the public relations society of america, organizations and their publics use public relations as a communication strategy to build relationships that are mutually beneficial. medical communicators help educate the public by sharing relevant health information through their own writing, and those with a marketing and public relations http://www.amwajournal.org v37 n1 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 38 abstract this article will discuss the real-world application of agile project strategies to expedite the development of high-quality deliverables that satisfy the structure and rigor of the regulatory environment. the coronavirus disease 2019 (covid-19) pandemic challenged regulatory writers not just to rethink the structure of their workdays and the nature of their interactions with their colleagues but to leverage technology and adopt strategic project thinking to help their teams meet aggressive timelines while working in the virtual workspace. scenarios will include the application of agile project strategies to working on covid-19 programs or programs heavily impacted by covid-19, from expedited submission processes to rapid responses to regulatory authority requests for information. this assessment will include what strategies worked well, what strategies did not, and what an agile project should look like within the regulatory writing space. across industries, different methodologies for project management are used. the most popular include the waterfall, kanban, adaptive project framework, lean, and critical path methodologies.1 the reason for the variety in project management styles is simple—optimal delivery of a product in any industry requires processing of multiple intrinsic and extrinsic variables. in our experience in the biotech and pharmaceutical space, most regulatory writing deliverables have been planned by using the waterfall methodology; but the current space has become more dynamic, influenced almost daily by decisions made by regulators, research committees, health care professionals, venture capitalists, and— most importantly—the scientific method itself. delivering quality regulatory documents in the current space requires methodology adaptation to an evolving landscape. as the discipline of project management in other industries has evolved to account for ever-increasing change, with project lifecycles now ranging from the very plan-driven to the iterative to the highly adaptive,1 the authors considered whether non-waterfall methodologies could be adapted to regulatory writing. this article briefly describes the waterfall approach historically used in medical writing and discusses the application of alternative project management methodologies to achieve quick, adaptive, and controlled regulatory document development. the waterfall approach and its pitfalls regulatory writing project management typically has followed the waterfall method, which aligns with document development in an environment requiring sponsors to implement and maintain quality systems. the standard operating procedures (sops) that underpin these systems are often prescriptive, delineating steps that can be documented, thereby demonstrating compliance. project timelines tend to mirror these sops in their fixed, stepwise progression toward controlled content creation. project management software uses predecessor/successor inputs to capture this progression and can leverage this information to generate understandable outputs for coauthors and non–medical writing stakeholders. the benefits of the methodology include ample time for both the regulatory writer and coauthors to think, research, and then write and align reviewer comments and changes across the document before the next iteration. this project management methodology is ideal for projects with a predictable path.1 the format and content of nonpivotal clinical study reports (csrs), annual investigator brochure updates, or developmental safety update reports (dsurs) are well described in the regulations, generally limiting stakeholder impact on document structure, and the timelines may be defined by regulation (eg, dsurs) or may be driven by fewer extrinsic factors (eg, a competitive landscape). whereas the waterfall methodology relies on predictability, the regulatory writing environment has changed dramatically since the pandemic began. regulations regarding coronavirus disease 2019 (covid-19) and non–covid19 studies, contract research organization (cro) and site procedures, and sponsor priorities shifted to enable acceljeanette m. towles and jason s. casavant / synterex inc, boston, ma agile strategies in the rigid regulatory environment research http://www.amwajournal.org amwajournal.org 39agile strategies in the rigid regulatory environment erated clinical evaluation of diagnostic, therapeutic, and preventive products to address the pandemic. regulatory writing projects have been initiated without an assessment of requirements (eg, initiation of a full protocol without identified study endpoints due to an evolving understanding of the clinical course of the disease), well-vetted concepts, or access to real-time investigator clinical observations.2 consequently, regulatory writers have been asked to coauthor in real time in a manner significantly divergent from the stepwise collaboration afforded by the traditional waterfall methodology. alternative project management strategies during the first half of 2021, our operational and executive teams reviewed opportunities for continuous improvement. we focused on several covid-19–related regulatory writing projects because of a recent uptick in requests for supporting projects with accelerated timelines and imperfectly defined parameters similar to what we had observed with covid-19–related projects, leading us to wonder if a linear way of working might become a relic and if we might need to adapt all or part of our business model. the scenarios we selected for review included the following elements: • required multiple resources within the company (eg, regulatory writer and operations support). • required >50% resource utilization for the regulatory writer for a discrete period. • timelines did not follow a sequential pattern (ie, one or more authoring steps were concurrent), so the writer was unavailable for other projects. • coauthoring with the client was done by using collaborative technology. the selected projects had a timeline that was prospectively created and/or maintained by the regulatory writer and that was available for resourcing manager review. scenario 1 at the time of project initiation, just shortly before the pandemic was declared, one could count on both hands the number of covid-19–related studies in clinicaltrials.gov. the regulatory writer used relevant software and searches of clinicaltrials.gov for recruiting covid19 treatment studies to collect clinical intelligence and develop a protocol synopsis, which was then used to facilitate regulatory agency, cro, and site interactions (table 1). after receipt of food and drug administration (fda) feedback on the pre–investigational new drug application (ind) package and about 2 weeks before ind submission, the fda issued guidance on covid-19–related study conduct.3-5 given that the protocol was nearly finalized, the team had to quickly interpret the guidance, implement any changes addressing conflicts with prior clinical intelligence and an evolving standard of care, and confirm those changes with internal and external stakeholders (eg, confirm that the fda’s oxygenation cutoff for disease severity matched the site’s cutoff). traditional stepwise project management methodologies were recognized as being too rigid for this dynamic environment, so the team incorporated strategies used in more adaptive methodologies. change was rapidly communicated through a phone tree and scheduled check-ins every other day, with ad hoc meetings called for specific topics or live edits. the core authoring team was limited to the regulatory writer, clinician, and clinical trial manager, table 1. scenario 1: medium-sized pharmaceutical company filing an ind in a covid-19–related indication type of product treatment (covid-19) requirements file ind systems teams, pleasereview (sponsor owned) regulatory writing resources external consultants (no established mw department) timelines pre-ind meeting request package 3 weeks ind (2 weeks from pre-ind feedback) stakeholders us regulators; later in the process, global regulators irb/iec internal team internal management study sites external philanthropy groups (funding) cro regulatory landscape guidance still being drafted, no guidance available on endpoints and objectives yet; heavy cross-referencing to an existing ind in another indication risks proceeded with protocol and informed consent form writing at risk ahead of preind feedback to meet timelines; defer many of the details on testing and analysis to ancillary documents (eg, pharmacy manual) because details not available yet (eua for diagnostics had occurred only a few weeks previously2) project management strategies communication phone tree stand-up meetings every other day between work sprints resource layering for ancillary writing tasks small core team cloud-based authoring and review covid-19, coronavirus disease 2019; cro, contract research organization; eua, emergency use authorization; iec, independent ethics committee; ind, investigational new drug application; irb, institutional review board; mw, medical writing. http://www.amwajournal.org http://clinicaltrials.gov http://clinicaltrials.gov amwajournal.org 40agile strategies in the rigid regulatory environment with supplemental members reviewing specific language in the protocol, which enabled efficient and focused authoring during short work sprints. all authoring was done in teams, with access managed by a dedicated information technology (it) professional who was part of the phone tree. a regulatory writing operations associate supported the writer by formatting, locating references, and managing citations. the document underwent a single round of management review in pleasereview, during which most of the reviewers used the software’s commenting feature to provide substantive feedback. the team vetted management comments together, and the core authors discussed any outstanding issues with their line management outside of the review and reported back the results of the conversation. roundtables attended by all core and supplemental authors as well as the management reviewers were used to efficiently align on resolution of any pending comments. structured communication and cloud-based tools were leveraged by the small core team, enabling them to efficiently respond to shifts in the regulatory landscape while also permitting team members to author, consult with management and subject matter experts, and achieve consensus. the team successfully provided a quality deliverable during an uncertain time in drug development and advanced an important potential treatment for covid-19. scenario 2 this project proceeded in the context of hyper-compressed timelines and the need to look at not only new interim data but also cumulative data (table 2). while the cro was pulling the marketing application documents together and facilitating the various reviews, full-time employees (ftes) and consultants provided oversight and management of timelines and risks and facilitated interactions with multiple internal and external stakeholders. because of the time constraints on the project, live data reviews were employed, during which the cro regulatory writer engaged directly with stakeholders early in the drafting process, allowing for real-time drafting, consensus building, and a reduction in draft cycles. the success of this approach was contingent upon the availability of the correct attendees and their endorsement of this adaptation over more traditional iterative authoring and review processes. although scenario 1 used a small core team with targeted reviewers to achieve consensus, this scenario used a larger review team, which included team members and management, to increase functional alignment at approval, which worked in large part because of the team trust at all levels. in this scenario, the use of pleasereview followed highly prescriptive sops that did not enable the internal regulatory writers and the consultants (who only had reviewer licenses) to review live copies of fundamentally relevant documents (eg, parallel review of in-development csrs or summary modules and in-development clinical overview). the system was used for a stepwise review, comment reconciliation, and closeout workflow. although pleasereview allows for the attachment of reference documents to the review, those documents were changing concurrently, rendering this option ineffective. ultimately, a system was needed to facilitate document finalization with the key subject matter experts after team review. an initial attempt to use sharepoint for this activity failed because of a lack of prospective access management as well as restrictions on the use of guest accounts (for external consultants and regulatory writers) for internal sharepoint sites; the writer and subject matter expert resolved outstanding issues via email. table 2. scenario 2: medium-sized pharmaceutical company filing a marketing application in a covid-19–related indication type of product preventive (covid-19) requirements file a marketing application systems teams, pleasereview (cro owned), veeva regulatory writing resources cro writers internal fte external consultants functioning as em bedded fsp (established mw department) timelines 12 weeks (changed to 8 weeks)—critical/ asap stakeholders global regulators, including multiple us bodies irb/iec internal team internal management study sites cro regulatory landscape rapidly evolving; constant feedback from multiple agencies and the need to resolve divergent feedback; prior eua and global conditional approvals risks competitive landscape is a significant concern multiple overlapping documents to meet timeline sponsor exponential growth in a short timeframe project management strategies communication phone tree stand-up meetings every other day between work sprints resource layering for ancillary writing tasks small core team cloud-based authoring and review asap, as soon as possible; covid-19, coronavirus disease 2019; cro, contract research organization; eua, emergency use authorization; fsp, full-service provider; fte, full-time employee; iec, independent ethics committee; irb, institutional review board; mw, medical writing; sme, subject matter expert. http://www.amwajournal.org amwajournal.org 41agile strategies in the rigid regulatory environment as a lesson learned from other submissions on the same program and aligned with sprint-style project management methodologies, the regulatory writing team attended specific key meetings, communicating about the submission and permitting the team more time to complete action items. the sponsor’s head of medical writing attended general meetings and cro meetings, and the external consultants divided up cro meetings and other internal meetings; all external consultants and cro writers attended most document roundtables and stand-up meetings. those who did not attend could access meeting information via a teams chat, email, or a onenote summary. overall, although there were observations for future process improvement, the regulatory and quality requirements of this dynamic submission were met, and a submission was filed on time for approval of a groundbreaking regulatory document. scenario 3 the work for this early-phase protocol began as sites across the united states began restricting access because of infectious disease procedures.2 the protocol for this critical disease had been finalized around the same time the first covid-19 cases were reported in the united states, and the study was in start-up (table 3). as covid-19 cases began to rise globally, the sponsor’s concerns mounted regarding the likely impact on study enrollment as well as the ability to ensure proper safety follow-up if patients were enrolled. a protocol amendment was planned to allow for alternate assessments and to reduce the overall travel burden and the chance for covid-19 exposure for the patient, with the amendment including home collection of samples, select phone visits, alternative media for patient-reported outcomes and informed consent, and home nursing for safety assessments and drug accountability and dispensation (as a last resort due to high cost). guidance from the fda on the conduct of studies during covid-19 was issued several weeks into protocol development and informed several key mitigations that were planned6; however, at the time the guidance was issued, the pandemic was evolving, and the agency determined that prior public participation for the guidance was not feasible or appropriate, so early guidance was open to some interpretation.7 the core authoring team was limited to the regulatory writer, regulatory writing operations associate, clinician, clinical trial manager, regulatory strategist, program manager, and drug supply/ chemistry, manufacturing, and controls manager. involvement of each function in this group assured that the protocol was updated efficiently and accurately as conversations progressed with the cro and other vendors in daily, 1-hour, focused working meetings. authoring was done in teams, with access managed by an fte on the core authoring team. the document underwent a single round of management review using the sponsor-owned pleasereview platform, with the regulatory writer initiating and managing the review. similar to reviewers in scenario 1, reviewers in this scenario mostly utilized the commenting feature. the team vetted management comments together, and the core authors gained alignment with their line management outside of the review. all authors as well as the management reviewers attended the roundtables. by limiting the team to line-function representatives, employing regular meetings, and using authoring and review tools that promote transparency, the team effectively table 3. scenario 3: medium-sized pharmaceutical company amending a protocol in a non–covid-19 indication during the covid-19 pandemic type of product treatment (non–covid-19) requirements team was tasked with finding a way to add necessary flexibility to the study due to the evolving covid-19 closures in h1 2020 systems teams, pleasereview (sponsor owned) regulatory writing resources external consultants (no established mw department) timelines 2 weeks stakeholders global regulators, including multiple us bodies irb/iec internal team internal management study sites cro regulatory landscape guidance on the conduct of studies during covid-19 newly issued; ind had been open for some time, with one other completed early-phase study risks q&a on fda guidance on the conduct of studies during covid-19 issued and updated during amendment authoring; implementation required active discussion with cro partners and subcontracted vendors to ensure proper description and execution; mitigations might not be successful and came with a high price tag; small company with limited resources project management strategies resource layering for ancillary writing tasks core authoring team representing each function cloud-based authoring and review covid-19, coronavirus disease 2019; cro, contract research organization; fda, food and drug administration; h, half (of the year); iec, independent ethics committee; ind, investigational new drug application; irb, institutional review board; mw, medical writing; q&a, questions & answers. http://www.amwajournal.org amwajournal.org 42agile strategies in the rigid regulatory environment used multiple minor draft sprints to implement information and gain consensus as it became available in between meetings with stakeholders and partners. the project aligned with emerging regulatory guidance while mitigating the impact of covid-19 on enrollment, study feasibility, and participant safety. discussion each regulatory writing project has a unique budget and unique collaborators, timelines, risks, and gaps. the regulatory writer and regulatory project manager must discuss the linkages of a project with department and company goals and determine the project management principles to apply; gathering the project requirements should be a deliberate process even in the face of urgent issues or tight timelines. in consideration of the scenarios described in this article, we determined that the strategies that best balanced a controlled process with adaptability were derived from the agile project management method (figure 1), particularly the scrum framework. this method, often used in software development, is employed when the “requirements,” or specifications the software needs to meet, change over time as a result of competitive intelligence or other factors; this method uses continuous planning to rapidly identify and implement change.8 in all 3 of our scenarios, microdrafts were produced in short bursts, or “sprints,” in between other milestones (eg, internal meetings, stakeholder meetings), continuously delivering a work product informed by feedback at all stages (figure 2). early and frequent delivery of microdrafts maintains project momentum and reduces the overall amount of work being done later in the process as well as the potential that late-breaking information could jeopardize quality or figure 1. principles of agile project management. source: rigby et al.8 figure 2. waterfall compared with agile methodology for document production. adapted with permission from kissflow.10 . http://www.amwajournal.org amwajournal.org 43agile strategies in the rigid regulatory environment on-time delivery. regulatory writers often leverage relationships to deliver quality documents on time, but the commitment in these scenarios to produce high-quality microdrafts required the authoring team to be in regular contact to self-regulate and agree on the tasks to be completed, check on progress, and course correct as needed. the focus on optimal technical quality and design in this method is inherently aligned with the rigor required for regulatory documentation as well as the need to position regulatory documentation for the intended audience, and the method’s approach to simplicity is also aligned with the latest “lean authoring” trends in regulatory writing.9 any methodology must be paired with the best tools, systems, and practices. setting expectations for how the team will work together and outlining roles and responsibilities, as well as scheduling regular checkpoints, were critical success factors in each scenario. in addition, proactively managing systems access and education as well as the availability of a dedicated it business partner to triage technical issues led to a more efficient authoring experience in some of the scenarios, even in a remote environment. it is also worth noting that no system is perfect; informing reviewers of any system limitations may help avoid pitfalls (eg, sponsor’s sharepoint is only set up to retain a certain number of versions, or contractors may not have compatible versions of microsoft office for coauthoring). lastly, archiving comments and decisions produced within any system requires regulatory writer discipline and should follow best practices and sponsor procedures to ensure that the rigor of regulatory documentation is met. project management software was critical to the success of each of these projects, but we also concluded that certain software features not often used by regulatory writers have become critical in assessing the available resource pool. for example, we had underutilized the project utilization feature to show the exact number of hours that a writer would be dedicated to a project within the start and stop dates for a task.11,12 as the pandemic progressed and project complexity increased, we implemented the software’s enterprise resourcing function, thereby enabling automatic initial notifications of project plan updates in between regular checkpoints. as a result of our analysis, we also invested in power bi business intelligence software to visualize data from multiple enterprise applications, including project management and customer relationship management software. implementation of this analytical tool empowered our leadership team to efficiently track resource allocation and other details, including funds remaining on work orders at both the client and contractor level.13 communication was paramount in the completion of each document in the scenarios. although the teams came to different conclusions about meetings, they each decided proactively how often and how to interact. setting such expectations up front in a project both increases the odds of the project’s technical success and manages the potential for over-accessibility and burnout. if the team cannot pull away from these digital tools because of an inundation of competing requests, they cannot get the work done. in one of these scenarios, the sponsor acknowledged that they historically had this exact issue and successfully addressed the feedback by dividing and conquering meeting attendance. thus, several of the principles within the agile method, including the preference for face-to-face interaction, maintaining a sustainable pace, and permitting the team to produce the deliverable, need to be balanced. the limitations of this review are that the assessments were retrospective (as necessitated by the level of engagement required during the pandemic to complete the above projects) and that the number of projects sampled was small. the types of projects sampled met specific criteria, and any projects that meet some but not all criteria (eg, covid-19 impact assessment for a csr) may require a combination of strategies depending on the context. in addition, in scenario 2, we were engaged as a resource late in the project planning phase and may have been able to influence the project management approach had we been involved earlier. as we further consider implementation of agile methodology in whole or in part, we acknowledge that the agile method of project management assumes that the workers’ time is retained, mostly available, and free of other distractions to be able to pivot. within regulatory writing departments, resources often cover multiple deliverables over multiple programs, so a shift to properly resource agile projects may lead to a higher overall departmental budget. the ability to potentially get to market sooner, however, may outweigh this burden. this concept also may not be representative of the way that all regulatory writers want to work and in fact will work best when the team wants to rapidly innovate in a unique way8; commoditization of this way of working could increase the risk for burnout and cause workers to lose faith in the principles of prioritization, trust, teamwork, and problem-solving that are core to this project management method. furthermore, this method may require writers with a requisite level of experience to be able to pivot as needed. considering that experienced writers represent a finite portion of the workforce and given that the demand for this style of working may increase, this could http://www.amwajournal.org amwajournal.org 44agile strategies in the rigid regulatory environment leave a large gap in the available resource pool that needs to be urgently addressed by leadership in the regulatory writing field. acknowledgement synterex would like to thank fulcrum therapeutics, goldfinch bio, and moderna, inc. for their support in writing this article. editorial credit jordan sedlacek, synterex inc. author declaration and disclosures: jeanette m. towles and jason s. casavant receive funds from several biotech and pharmaceutical companies for regulatory writing services. author contact: jtowles@synterex.com references 1. project management institute. a guide to the project management body of knowledge: pmbok guide. 6th ed. project management institute; 2017. 2. towles j. a brief history of the covid-19 pandemic and current efforts to combat it. amwa j. 2021;36(2):64-71. 3. center for drug evaluation and research; center for biologics evaluation and research. covid-19 public health emergency: general considerations for pre-ind meeting requests for covid19 related drugs and biological products—guidance for industry and investigators. us food and drug administration website. published may 2020. accessed september 3, 2021. https://www. fda.gov/media/137927/download 4. center for biologics evaluation and research; center for drug evaluation and research. covid-19: developing drugs and biological products for treatment or prevention: guidance for industry. us food and drug administration website. updated february 22, 2021. accessed september 3, 2021. https://www.fda. gov/media/137926/download 5. center for drug evaluation and research; center for biologics evaluation and research; center for devices and radiological health; center for veterinary medicine. statistical considerations for clinical trials during the covid-19 public health emergency: guidance for industry. us food and drug administration website. published june 2020. accessed september 3, 2021. https://www. fda.gov/media/139145/download 6. coronavirus (covid-19) update: fda issues guidance for conducting clinical trials. us food and drug administration website. published march 18, 2020. accessed september 3, 2021. https://www.fda.gov/news-events/press-announcements/ coronavirus-covid-19-update-fda-issues-guidance-conductingclinical-trials 7. us department of health and human services; food and drug administration; center for drug evaluation and research; center for biologics evaluation and research; center for devices and radiological health; oncology center of excellence; office of good clinical practice. conduct of clinical trials of medical products during the covid-19 public health emergency guidance for industry, investigators, and institutional review boards. us food and drug administration website. updated august 30, 2021. accessed september 3, 2021. https://www.fda.gov/ media/136238/download 8. rigby dk, sutherland j, takeuchi h. embracing agile: how to master the process that’s transforming management. harvard business review website. published may 2016. accessed september 3, 2021. https://hbr.org/2016/05/embracing-agile 9. bhardwaj p, sinha s, yadav rk. medical and scientific writing: time to go lean and mean. perspect clin res. 2017;8(3):113-117. 10. traditional vs agile project management—which one fits you? kissflow website. published september 6, 2021. accessed july 31, 2021. https://kissflow.com/project/agile/traditional-vs-agileproject-management/ 11. view resource workloads and availability in project desktop. microsoft website. accessed september 2021. https://support. microsoft.com/en-us/office/view-resource-workloads-andavailability-in-project-desktop-3ee16869-68ad-4e63-bcb3278ae34f7459 12. how work and duration are calculated with assignment changes. microsoft website. published april 7, 2021. accessed september 2021. https://docs.microsoft.com/en-us/office/troubleshoot/ project/calculate-work-duration-assignment 13. connect to project web pp with power bi. microsoft website. published july 25, 2019. accessed september 2021. https://docs. microsoft.com/en-us/power-bi/connect-data/service-connectto-project-online http://www.amwajournal.org https://www.fda.gov/media/137927/download https://www.fda.gov/media/137927/download https://www.fda.gov/media/137926/download https://www.fda.gov/media/137926/download https://www.fda.gov/media/139145/download https://www.fda.gov/media/139145/download https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-guidance-conducting-clinical-trials https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-guidance-conducting-clinical-trials https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-guidance-conducting-clinical-trials https://www.fda.gov/media/136238/download https://www.fda.gov/media/136238/download https://hbr.org/2016/05/embracing-agile https://kissflow.com/project/agile/traditional-vs-agile-project-management/ https://kissflow.com/project/agile/traditional-vs-agile-project-management/ https://support.microsoft.com/en-us/office/view-resource-workloads-and-availability-in-project-desktop-3ee16869-68ad-4e63-bcb3-278ae34f7459 https://support.microsoft.com/en-us/office/view-resource-workloads-and-availability-in-project-desktop-3ee16869-68ad-4e63-bcb3-278ae34f7459 https://support.microsoft.com/en-us/office/view-resource-workloads-and-availability-in-project-desktop-3ee16869-68ad-4e63-bcb3-278ae34f7459 https://support.microsoft.com/en-us/office/view-resource-workloads-and-availability-in-project-desktop-3ee16869-68ad-4e63-bcb3-278ae34f7459 https://docs.microsoft.com/en-us/office/troubleshoot/project/calculate-work-duration-assignment https://docs.microsoft.com/en-us/office/troubleshoot/project/calculate-work-duration-assignment https://docs.microsoft.com/en-us/power-bi/connect-data/service-connect-to-project-online https://docs.microsoft.com/en-us/power-bi/connect-data/service-connect-to-project-online https://docs.microsoft.com/en-us/power-bi/connect-data/service-connect-to-project-online v38 n3 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 44 before you know it, the amwa 2023 medical writing & communication conference will be here. this year’s conference is scheduled for october 25 through 28 in baltimore, maryland, just an hour’s drive from amwa’s home offices. register now for the conference at the annual conference website (https://www.amwa.org/page/conference). the annual conference committee has worked hard to pack the schedule with a variety of different topics in scientific communication, regulatory writing, health communication, and more. from educational sessions, workshops, posters, speed networking sessions, and roundtables to new learning modes such as vendor showcases and learning circles, the conference will offer something for beginner, intermediate, and experienced medical communicators. we’ll also have breaks and snacks to keep attendees refreshed. be sure to stick around until the end to listen to all our excellent speakers. this year's mcgovern award winners are the team of dr jessica steier and dr andrea love, and the alvarez award winner is dr katelyn jetelina. all are making important contributions to bring medical science to lay audiences and will share their great insights on the importance and role of medical communicators. one of the best features of these conferences is the ability to meet and socialize in person with other medical communicators from around the country. networking sessions, breaks, sunrise walks, and dinners offer attendees ample opportunities to meet each other. attendees come from a variety of backgrounds, and we bring vastly different experiences to our medical communication. (i myself have had a long, nonlinear career path.) learning from each other can take place in any moment, with anyone, at the conference. i’ve received some of the best insights and advice about medical communication during relaxed conversations over breaks and dinners. thankfully, baltimore has plenty of attractions—or distractions—to help attendees enjoy some downtime, too. the conference schedule will allow for visits to the city to take in the historic sites, museums, and oceanfront scenery. i encourage you to take advantage of your time in baltimore, and i hope to connect with you at the 2023 annual conference. continuous learning and connection at the 2023 medical writing & communication conference michele w. sequeira, ms, mba, mwc / 2023 annual conference committee chair 2023 conference preview the national aquarium crabs uss constellation baltim o re http://www.amwajournal.org https://www.amwa.org/page/conference amwajournal.org 57jam session for earlyto mid-career freelancers author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: kfeemster@greenfirecompany.com jam session for earlyto mid-career freelancers session moderator jennifer minarcik, ms / principal, jennifer minarcik biomedical communications, llc, moorestown, nj by suzanne morris, dvm, mwc about 15 freelancers and freelancers-to-be gathered at the amwa 2022 southeast regional conference in june to share their early freelance career experiences. some of the participants had just decided to take the freelance plunge and were eager for tips on setting up a new business whereas others with more experience were wanting to share lessons learned. session facilitator jennifer minarcik, ms, started the discussion by divulging some of the assumptions she had when she first started her freelancing career. she spoke to the misperception that freelance medical writers are all in competition with each other by pointing out the diversity of medical writing genres represented by the session’s participants. acknowledging that the varied nature of freelance medical writing lends to camaraderie rather than competitiveness among freelance medical writers led to a discussion of networking. although making connections with other freelancers may not translate to immediate work, networking can develop leads, elevate a freelancer’s marketplace presence, and unearth other benefits. one of the more valuable of these benefits may be finding a good mentor. the more experienced session participants extolled the benefits of mentorship in guiding their early freelancing careers. but how does a new freelancer go about finding a mentor? those who had who have benefitted from mentorship described a relationship which naturally developed from a networking connection. another early career misstep minarcik discussed was the compulsion to take on every project, and the consequent erosion of the work-personal life border. minarcik and the other more seasoned freelancers agreed that project selectivity fosters a reasonable work schedule and, potentially, better clients. because part of cultivating a work-life balance entails supporting work hour productivity, the discussion then turned to productivity strategies. for example, creating a schedule with built-in time to respond to distractions like emails supports productivity during work hours. protecting work time also may require establishing boundaries with clients by responding to clients only during set work hours or at set times during the week. the conversation turned to some of the other nuts-andbolts of running a freelance business. as with most freelance medical writing discussions, the topic of contracts arose, albeit briefly. the take-home message for new freelancers was to carefully review contracts, particularly with respect to payment parameters. some of the freelancer participants who were just forming their businesses asked for advice on insurance and accounting. the responses from the more seasoned participants were mixed—few had insurance, and several used accounting services and software. but the consensus was that some form of accounting assistance was very helpful. inevitably, the discussion turned to what may be the most daunting aspect of freelance medical writing or freelancing in general: marketing. the importance of presence online, particularly on platforms like linkedin, was discussed at length by several seasoned freelancers. for introverts averse to overt self-promotion, a less intimidating approach may be simply posting about topics of interest, which creates an online presence and can garner attention. another strategy was to investigate companies associated with relevant forms of medical writing on linkedin and make connections with their employees. whether to solicit potential clients through email was a point of debate, with the more experienced freelancers advising that if done, it should be targeted and could backfire by annoying the targeted client. the discussion of marketing repeatedly circled back to value of networking, which can be done online and in person through, for example, amwa events. and in keeping with its overriding theme, this amwa session ended with participants exchanging their business cards. suzanne morris is the owner of concrete medical writing, llc, in st. petersburg, fl. author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. author contact: suzanne@concretemedicalwriting.com public relations in medical communication speaker katrina r. burton, bs / public relations program director by lisa kuhns, phd according to the public relations society of america, organizations and their publics use public relations as a communication strategy to build relationships that are mutually beneficial. medical communicators help educate the public by sharing relevant health information through their own writing, and those with a marketing and public relations http://www.amwajournal.org amwajournal.org 58public relations in medical communication (pr) background offer a unique skill set to health care institutions. those trained in health care pr can expand their reach through a variety of platforms, including earned media, owned media, and bought media, using public relations as a tool to educate the public on medical and public health information. pr plays a critical role in health care because it allows institutions and organizations to raise awareness about health, share groundbreaking research, and help people take control of their own health. a new treatment is less impactful if the public is not aware of its launch. pr also helps to highlight important health initiatives, reach underserved populations, and amplify the effectiveness of community and hospital-based programs and treatments. a story of patients sharing their health care journey because of the latest treatment may offer hope to others on the same journey. accurate and factual information on health initiatives, research developments, and patient programming helps build trust in the medical community. thus, health care pr helps spread information that can help people live healthier and more fulfilling lives. in her presentation at the 2022 amwa southeast regional conference, katrina r. burton, program director of pr at the university of texas md anderson cancer center, explained why it is important for medical communicators to understand the dynamics of how pr can leverage relationships between medical institutions and the public. her presentation described best practices for developing a strategic pr plan, discussed how to identify and engage with stakeholders, and provided tips on how to build media relationships. best practices for developing a public relations plan pr experts within a department typically develop a pr or media plan. burton discussed the components of developing a winning plan. in her words, the plan begins by determining the “it” or the “what” that is being promoted. the “it” can be a/an • clinical or patient program • award or recognition • research study • sponsorship or partnership • important milestone • patient and clinical services • facility opening or launch • patient testimony once the “it” has been determined, the stakeholders are engaged, and the supporters or collaborators are identified. the pr plan also should include the costs and budget. costs can depend on what is being promoted and may be known or discoverable. stakeholders and collaborators may be involved, and the budget may involve different departments, divisions, and institutions. the funds may come from grants or donors. to complete the pr plan, the target audience must be identified, key messages developed, a timeline and deliverables determined, and the desired communication channels established. the communication channels selected may depend on the target audience, content, and timelines. building relationships to execute the public relations strategy every good plan involves more than the pr expert. in fact, it involves a multitude of people who are experts in social media, the web, video, photography, and more. burton emphasized relationships are the fundamental component of any pr role and important for a successful plan. building relationships with the internal team, media, and influencers helps to facilitate the plan’s implementation. relationships also help to build rapport and trust, open communication channels, and strengthen an organization’s personal brand. “operating in the public relations space as a medical communicator is an opportunity to enhance outreach opportunities, engage with stakeholders, and build collaborative relationships,” said burton. “it also provides an opportunity to share impactful stories of hope and important health information to help people live healthier lives.” building relationships also defines roles and helps manage expectations. importantly, establishing good relationships creates loyalty. “for me, building relationships with media is understanding their beat or area of focus, learning their reporting style, being familiar with the type of stories they cover, knowing their audience, and understanding how they engage on social media and with others,” said burton. “the stories i pitch to media are important to me, and i want them to be just as important to media, who in turn cares about their audience.” lisa kuhns is a freelance medical writer at lgk medical writing, llc, based in woodbine, ga. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: lisa@lgkmedicalwriting.com http://www.amwajournal.org contents v37 n3 fall 2022 3 4 9 11 16 21 28 from the editor � michael g. baker an update from the amwa diversity and inclusion assessment task force � gail v. flores feature amwa: who we are � elizabeth kukielka freelance focus jam session for seasoned freelancers—part 2 � brian bass, with commentary from cathryn d. evans, phyllis minick, and sherri bowen ce craft corner avoiding bias and ensuring content validity in accredited continuing education: what do the latest accme standards mean for medical writers? � andrew d. bowser social media diversity, equity, and inclusion embraces accessibility � dean colston, rebecca fein, killian kleffner, and vanessa saunders in the service of good writing if i were king of the forest…! – the grammar, meaning, and logic of conditional statements � laurie endicott thomas biography eric wentworth martin – pharmacist, researcher, author � tom lang 44 28 4 editor-in-chief michael g. baker, phd managing editor rachel mosher, ma section editors progress in publications qing zhou, phd, els regulatory insights jennifer bridgers, ms, mwc science series naomi bishop, md social media jennifer minarcik, ms statistically speaking thomas m. schindler, phd everyday ethics julie ravo, ba, ma freelance focus ruwaida vakil, msc technology talk kate mckiernan, ma, els ce craft corner haifa kassis, md practical matters elizabeth kukielka, pharmd, ma, ms, mwc regular contributors freelance focus brian bass, mwc melissa l. bogen, els sherri bowen, ma, els lori de milto, mj cathryn d. evans gail v. flores, phd phyllis minick in the service of good writing laurie endicott thomas, ma, els editors in memoriam lori l. alexander, mtpw, els, mwc ronald j. sanchez 2021–2022 president katrina r. burton, bs 2021–2022 board liaison r. michelle sauer gehring, phd, els 2021–2022 staff liaison shari rager, ms, cae executive director susan krug, ms, cae graphic designer amy boches, biographics editorial office: managingeditor@amwa.org. instructions for authors available at: www.amwajournal.org. advertising: contact marketing@amwa.org or (240) 239-0940. all advertising is subject to acceptance by amwa and should be for products and services relevant to professional medical communicators. amwa is not responsible for the content of advertising and does not endorse any advertiser or its products or services. subscription: the amwa journal is published quarterly. subscription is included with amwa membership. nonmember subscriptions cost is $75 per year. contact: american medical writers association, 30 west gude drive, #525, rockville, md 20850-4347. phone: (240) 238-0940; fax: (301) 294-9006; email: amwa@amwa.org. the amwa journal is in the mla international bibliography and selectively indexed in the cumulative index to nursing and allied health literature (cinahl) print index and the cinahl database. the opinions expressed by authors contributing to the journal do not necessarily reflect the opinions of amwa or the institutions with which the authors are affiliated. the association accepts no responsibility for the opinions expressed by contributors to the journal. ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwa journal mission statement in support of the mission of the american medical writers association (amwa) and to advance the broader profession, the amwa journal publishes content that reflects the interests, concerns, and expertise of medical communicators. its purpose is to inform, inspire, and motivate medical communicators. m o re v37 n3 / 2022 32 amwa news the american medical writers association (amwa) announces new diversity, equity, and inclusion statement � susan krug from the president � katrina r. burton amwa’s third annual meeting of medical writing executives tackles value, leadership, change, recruitment, and retention � brian bass amwa fellowships � sarah dobney harold swanberg distinguished service award � sarah dobney the golden apple award � sarah dobney slate of officer candidates for the 2022–2023 election � elise eller 44 conference 2021 walter c. alvarez award address � harriet a. washington reach new heights at the 2022 medical writing & communication conference � kimberly korwek 51 calendar of meetings contents http://www.amwajournal.org v38 n1 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 56 bad writers write badly for 2 simple reasons: they choose the wrong words and put them in the wrong order. as a result, they write bad sentences. then, they usually put those bad sentences in an order that makes no sense. a good writer writes good sentences and puts them in a meaningful order, so that the writer’s ideas flow smoothly from the page into the reader’s mind (see key points). good writers also break up their text into manageable chunks, called paragraphs. writing guides often tell you to use the paragraph as the unit of composition. each paragraph can focus on a particular topic or idea. the break between paragraphs gives readers a chance to rest, to think about what they have just read. the break also alerts the reader that there may be some shift of focus. what is a paragraph? the word paragraph came from the roots para(meaning beside) and graphein (literally, “to write”). in ancient greek punctuation, a paragraphos was a punctuation mark, derived from the letter gamma (γ), that was used to mark a division in text (such as between speakers in a dialogue). the paragraphos was the only punctuation mark that the greek philosopher aristotle mentioned, and he took a dim view of it. in his rhetoric, aristotle argued, “a sentence should break off with the long syllable: the fact that it is over should be indicated not by the scribe, or by his period-mark in the margin, but by the rhythm itself.”1 this advice may have made sense in ancient greek, but it is utterly useless in english. by the middle ages, scribes were using a paragraphus (the latinized version of paragraphos) to mark the beginning of a new section in a discourse. they often used a capital c, which stood for capitus (head). for clarity, they started putting a single vertical line through the c, then 2. eventually, the sign developed into our modern pilcrow symbol (¶), which word processing programs still use to indicate the end of a paragraph.2 (the word pilcrow is a corrupted version of the word paragraphus.) meanwhile, the word paragraph started to mean the block of text that was set off in some way, such as by adding a line of space between paragraphs by indenting the first line of the new paragraph, or by adding a large initial capital letter to the beginning of the new paragraph. in typeset text, you can use a dingbat (eg, ) to signal a paragraph break that occurs when you cannot use a line return. paragraph structures you probably learned in school that every paragraph should have a topic sentence, and that the rest of the sentences in the paragraph should support or build on that topic sentence. plenty of paragraphs do have that structure, but many well-written paragraphs do not. i don’t worry about whether each of my paragraphs has a topic sentence. instead, i try to put my sentences in a logical order and then make sure that i put in paragraph breaks wherever there is a big enough change of topic or focus. nevertheless, i find that many of my paragraphs do have a topic sentence. instead of worrying about how to generate a topic sentence for each paragraph, think about the purpose of the paragraph. if a paragraph is well written, its structure will generally reflect its purpose. to tell part of a story a narrative is a story, an account of a series of related events. events are facts that have some restriction related to time: events have a before, a during, and an after. each paragraph can tell a portion of the story. a narrative might not have a topic sentence in each paragraph. instead, a paragraph may contain a series of sentences of equal importance, each describing a particular event: this happened, this happened, this happened, and so on. each of these sentences may be equally important. however, you might find some places in which there is a natural break in the action (eg, “on the following day, …”). those are good places to insert a paragraph break. in a narrative, you may need to add some sentences that provide commentary to explain the context or meaning of a particular event. the sentence that recounts the event and the sentences that provide commentary about that event can be set apart as a separate paragraph. in a simple narrative, you can recount a series of events that happened one right after another. but to tell some laurie endicott thomas, ma, els / freelance writer, madison, nj paragraph structures in the service of good writing http://www.amwajournal.org amwajournal.org 57paragraph structures stories, you need to use a nonlinear timeline. for example, you may have to recount the events in the order that you learned about them instead of the order in which they happened. you may have to describe events that overlap each other, or events that happened simultaneously in 2 different places (“meanwhile, back at the ranch…”). you may have to describe the same event as seen from several points of view (as in the famous movie rashōmon). thus, you may have to depart from a simple chronological account. instead, you may have to write subnarratives that you must then weave into the larger narrative. when writing a simple or complicated narrative, you can use a paragraph break whenever you need to signal a discontinuity in the action or a shift in topic, setting, or perspective. if you need to make a larger break in the narrative, you can use a text break (signaled by white space and perhaps a printer’s ornament) or start a new chapter. to give instructions instructions are a series of commands, sometimes interspersed with explanations. you can usually put the commands in the order in which they are to be followed. however, in an ordinary recipe, you may need to refer to a separate recipe for how to prepare one of the ingredients. for example, a recipe for sourdough bread would call for sourdough starter. thus, there is generally a separate recipe for how to make and maintain the starter. for this reason, the timeline in a recipe might not be strictly linear. in a recipe or any other set of instructions, you can use paragraph breaks to separate major steps in the process. for example, when writing about how to perform a surgical procedure, you might devote the first paragraph to the options for anesthesia, the second to patient positioning, the third to the initial incision, etc. you might also need to write a separate set of instructions for the anesthesiologist. to describe or explain something a paragraph that describes or explains something may have a topic sentence that defines what the thing is and several other sentences that give more information about that thing. when you need to shift topic or emphasis, add a paragraph break. note that in the passage below, there is a clear topic sentence in the first and third paragraphs, but not in the second paragraph: insulin is the hormone that allows the body to react to a meal [topic sentence]. insulin is a peptide hormone that is secreted by the beta cells in the islets of langerhans in the pancreas. during fasting, these cells release only a small trickle of insulin (basal or constitutive insulin secretion). various stimuli that are associated with a meal cause a burst of insulin secretion. these stimuli include hormones released by the gastrointestinal tract in response to feeding, as well as the rise in blood glucose that occurs after a meal. insulin then acts on cells throughout the body, to stimulate them to react to the meal. insulin’s most familiar actions are on blood glucose levels. insulin stimulates liver and muscle cells to convert glucose to glycogen for storage. insulin also stimulates heart and muscle cells to express glut4 transporters, thus allowing those cells to take in more glucose to use as an energy substrate. these two effects cause a reduction in blood glucose. however, insulin also stimulates adipose cells to store the fat that is being absorbed from the meal. it also stimulates cells throughout the body to use amino acids to synthesize proteins. thus, insulin is an anabolic (growth promoting) hormone. insulin also crosses the blood– brain barrier to enter the brain, where it has effects on cognition and behavior. crucially, insulin also acts on the alpha cells of the pancreas, to suppress the release of glucagon. glucagon is the hormone that opposes the actions of insulin, promoting mobilization of stored nutrients as opposed to the storage of circulating nutrients [topic sentence]. thus, it allows the body to survive a fast. like insulin, glucagon is a peptide hormone…. the second paragraph does not have a topic sentence. instead, it provides more commentary on the topic sentence from the first paragraph. the paragraph break is useful because the first paragraph focuses on insulin secretion, whereas the second paragraph focuses on insulin’s effects. the third paragraph does more than shift focus. it changes the topic to a different hormone: glucagon. depending on the overall structure of the piece, you might insert a new heading before the third paragraph. to explain how parts make up a whole you can use a paragraph to give an overview of a structure. the topic sentence will say that the whole consists of several parts. other sentences may address each individual part. if you have a series of parallel sentences, you might want to present them as a bulleted list. note that the bulleted list makes a long paragraph easier for your reader to digest: the pancreas has exocrine and endocrine functions [topic sentence]. an exocrine gland is one that secretes products through a duct [definition]. the pancreas secretes digestive enzymes (e.g., amylase, lipase, and proteases) through a duct that empties into the duodenum, which is the first few inches of small intestine. in contrast, endocrine glands release their http://www.amwajournal.org amwajournal.org 58paragraph structures products directly to the bloodstream [definition]. the endocrine functions of the pancreas are performed by the islets of langerhans, which are small clusters of hormone-producing cells that are scattered throughout the pancreas. although these islets make up only about 1% to 2% of the mass of the pancreas, they receive 10% to 15% of its blood flow. several different kinds of cells are found in the islets, each producing a different hormone or hormones: • alpha cells produce glucagon • beta cells produce insulin and amylin • delta cells produce somatostatin • epsilon cells produce ghrelin • gamma cells, also called f or pp cells, produce pancreatic polypeptide. to say that something is true according to the greek philosopher plato, knowledge is justified true belief.3 suppose that you want your paragraph to persuade someone to accept a claim as truth. you can state the claim in a topic sentence, which often ends up at the beginning or the end of the sentence. you can then add a sentence or 2 to define your terms or clarify what you mean by the claim. then, you write one or more sentences that provide evidence to support the claim. you might also add a sentence or 2 to explain why the evidence justifies your claim. in the following paragraph, the claim is the final sentence: pre-eclampsia is defined as hypertension that starts after week 20 of gestation [definition]. all of the features of pre-eclampsia represent either the effects of poor circulation (e.g., poor placental development, intrauterine growth restriction, and the hellp syndrome [hemolysis, elevated liver enzyme levels, and low platelet levels]) or the body’s attempt to compensate for or correct low blood volume (e.g., robust activation of the renin-angiotensin-aldosterone system, leading to hypertension and edema) [evidence]. aldosterone promotes retention of salt and water; but if the woman does not have enough plasma protein to hold the extra fluid within the vascular space, it will migrate to the intracellular space. thus, the extra fluid will produce edema instead of expanding intravascular volume. pre-eclampsia is most common among women who are prone to hypoproteinemia and thus to hypovolemia (e.g., undernourished women and women with gestational diabetes) and among women who are carrying more than one fetus (and thus need a greater expansion of blood volume) [evidence]. preeclampsia can be managed with careful use of intravenous colloids (albumin or hetastarch) to expand blood volume [evidence]. all of this evidence supports the same conclusion: pre-eclampsia results when the woman does not have enough plasma protein to expand her blood volume enough to meet the demands of pregnancy [claim]. this is a long and dense paragraph. you might be tempted to split it into 2 paragraphs, just to give the reader a break. but if you do that, then the reader might not be sure what you mean by “all of this evidence.” to solve this problem, you might put the claim after the definition and then offer the evidence. if so, you will have to reword the claim, “pre-eclampsia occurs when a pregnant woman does not have enough plasma protein to expand blood volume sufficiently to meet the demands of pregnancy.” to offer advice whether you are expounding truth or offering advice, your argument may follow a similar structure. the difference is the mood of the verb in the topic sentence: to state what is true, you use the indicative mood, which is a realis modality. but to give advice or commands, you use an irrealis modality. the advice may be in the form of a command (imperative mood) or a deontological statement (what should or must be done or what you think is needed). the advice could be implied by a conditional statement, which is a statement about what would or can happen, if a condition is met. (for more information on linguistic modality, see shoulda, woulda, coulda!4). the topic sentence that offers the advice could come at the beginning or the end of the paragraph, or even somewhere in the middle. some of the other sentences could clarify the advice or explain why the advice is sound: to prevent pre-eclampsia, we must provide nutritional support for undernourished women and nutritional counseling for overnourished women [topic sentence: advice]. pregnant women with protein-energy malnutrition are at risk for pre-eclampsia because they convert too much of their blood proteins to glucose, for use as an energy substrate [explanation]. these women simply need more food [advice]. in contrast, overnourished women are at risk for pre-eclampsia because a high-calorie, high-fat diet promotes insulin resistance, which leads to oversecretion of glucagon, which promotes the excessive conversion of plasma protein to yield excess blood glucose [explanation]. when added to the physiologic insulin resistance of pregnancy, the insulin resistance resulting from overnutrition can lead to gestational diabetes, which is a temporary form of type 2 diabetes during pregnancy [explanation]. fortunately, the insulin resistance from http://www.amwajournal.org https://cdn.ymaws.com/www.amwa.org/resource/resmgr/journal/issues/2016/2016v31n4_online.pdf amwajournal.org 59article title overnutrition can be rapidly corrected by a change to a low-fat, high-fiber, high-carbohydrate diet [advice]. notice that the paragraph has the same basic structure as the topic sentence: we must do a and b. the other sentences in the paragraph provide clarification and justification for a and then b. this is the order that the reader expects from having read the topic sentence. relevance and order to use the paragraph as your unit of composition, you need to do more than add hard returns every so often. you must analyze how the sentences in the paragraph fit together. thus, you might ask yourself the following questions: • does the paragraph contain all of the information that i need to make this particular point? if not, what must i add (eg, a definition of an uncommon word)? • does the paragraph contain any sentences that are not relevant to the point that i want the paragraph to make? if so, do i move those sentences to another paragraph or delete them? • are the sentences within my paragraph in the right order? would the writing make more sense if i put the sentences in a different order? • are my paragraphs in the right order? how does each paragraph fit into the overall structure of the piece? coherence when you study grammar, you focus on individual sentences. when you study writing composition, you learn to pay attention to the relationships between sentences. the goal is to learn how to achieve coherence in your writing: a logical, orderly, and aesthetically consistent relationship of parts. even if you put your sentences in the right order, you need to pay attention to words that provide connections between sentences and that clarify the relationships between ideas. these include repeated words, demonstratives, pronouns and possessive adjectives, and conjunctive adverbs. • the infection produces inflammation. this inflammation then…. (repeated word and a demonstrative [this]) • elizabeth blackwell was the first woman to receive a medical degree in the united states. her acceptance letter to geneva college was intended as a practical joke; but she earned the respect of professors and classmates, graduating first in her class. (she is a pronoun, and her is a possessive adjective.) • all men are mortal. socrates is a man. therefore, socrates is mortal. (therefore is a conjunctive adverb. for more information on conjunctive adverbs, see meanwhile, back at the ranch5). ignore bad advice if you read about how to write good paragraphs, you will find some pieces of advice that i never follow. primer language many writing guides tell you to avoid “primer language” (ie, short, simple sentences). ignore that advice. instead, we must struggle to keep our sentences as short as possible. as medical writers, we must explain complex ideas. to do that, we must often write complex sentences, which are long and hard to read. meanwhile, everyone wants us to produce readable text. writers for federal government agencies must follow the federal plain language guidelines.6 likewise, corporations also want us to produce text in plain language. readable text appeals to consumers and ranks higher in search engine results.7 sentence variety some writing guides say that it is bad to have a string of sentences that all have the same grammatical structure. for this reason, they urge you to alter the structure of some of your sentences, for the sake of variety. yet that method leads to madness. the structure of a sentence should be based on key points • write good sentences. • put your sentences in an order that makes sense. • use paragraph breaks to signal a shift in topic, emphasis, or point of view. • you don’t have to have a topic sentence in each paragraph. • paragraphs that serve a particular purpose will tend to have a corresponding structure (eg, a topic sentence that expresses a claim and other sentences that provide supporting evidence). • if you cannot see the whole paragraph at once on your computer screen, it is probably way too long. look for reasonable places to break it up. • to indicate a paragraph break, you can use a space between lines or an indentation of the first line of the new paragraph. • in a typeset piece, if you cannot use a line return to signal the end of a paragraph, use a dingbat (eg, ). • to indicate a larger break in a narrative, such as in a work of fiction, you can use white space and perhaps a printer’s ornament. • you can also break your text into sections, each of which contains a series of paragraphs. • section headings will help your readers navigate within the piece and may even help your readers find your piece online. http://www.amwajournal.org https://cdn.ymaws.com/www.amwa.org/resource/resmgr/journal/issues/2014/2014v29n3_online.pdf amwajournal.org 60paragraph structures the structure of the underlying idea. if your ideas vary naturally in structure, your sentences will also vary naturally in structure. by fixing the grammatical problems (eg, problems with modifier placement) that occur in so many sentences, you will automatically create variety in sentence structure. conversely, if you have a series of ideas that are parallel in structure, the sentences that express them will naturally be grammatically parallel. when that happens, you can set those parallel sentences out in a bulleted list. the items in a list are supposed to be grammatically parallel! author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: lthomas521@verizon.net references 1. aristotle. rhetoric. 3. 8. 6 (238-239). 2. stamp j. the origin of the pilcrow, aka the strange paragraph symbol. smithsonian magazine. published july 10, 2013. accessed january 7, 2023. https://www.smithsonianmag.com/artsculture/the-origin-of-the-pilcrow-aka-the-strange-paragraphsymbol-8610683 3. plato. meno. 4. thomas le. shoulda, woulda, coulda! amwa j. 2016;31(4): 184-185. 5. thomas le. meanwhile, back at the ranch. amwa j. 2014; 29(3):140-141. 6. federal plain language guidelines. plain language action and information network. accessed january 7, 2023. https://www. plainlanguage.gov/guidelines/ 7. readability and seo: how are they related? screpy. published june 29, 2021. accessed january 7, 2023. https://screpy.com/ readability-and-seo/ get fit with amwa f ast i nteractive t raining amwa’s fit series helps medical communicators stay healthy. in only 15 minutes—jog your memory, tone your writing muscles, build your core skills, and stretch your knowledge. www.amwa.org/fit only $15 each / approved for .5 ce topics in the series include: } misplaced modifiers } mean, median, and mode } dangling participles } measures of variability http://www.amwajournal.org https://www.smithsonianmag.com/arts-culture/the-origin-of-the-pilcrow-aka-the-strange-paragraph-symbol-8610683 https://www.smithsonianmag.com/arts-culture/the-origin-of-the-pilcrow-aka-the-strange-paragraph-symbol-8610683 https://www.smithsonianmag.com/arts-culture/the-origin-of-the-pilcrow-aka-the-strange-paragraph-symbol-8610683 https://www.plainlanguage.gov/guidelines/ https://www.plainlanguage.gov/guidelines/ https://screpy.com/readability-and-seo/ https://screpy.com/readability-and-seo/ v38 n3 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 41 named in honor of one of the founders of amwa, the harold swanberg distinguished service award is given to an active member who has made distinguished contributions to medical communication or rendered unusual and distinguished services to the medical profession. this year’s award goes to joan affleck, mba. her contributions to the field of medical writing have impacted not only amwa but also organizations and individuals around the globe. joan is an associate vice president at merck & co, inc, where she leads the medical writing department. she earned her mba from columbia university in new york, where she is a lang center innovation fellow and a regular guest lecturer. over the past 25 years, joan has built several medical writing departments from the ground up in the united states, europe, asia, south africa, and south america. these experiences in pharma, biotech, and contract research organizations give her a broad and international perspective of medical writing. beyond the influence of her skills on organizations at large, her leadership and interpersonal skills have supported, encouraged, and molded many individual medical writers in their professional journeys. joan has used her adaptive global leadership experience to help support amwa’s strategic planning, development of innovative solutions, and prioritization of key needs. as chair of the executive council from 2018 to 2021, joan led medical writing leaders to develop executive forum events and projects. in 2019, upon joan’s recommendation, amwa formed a workforce training committee to identify the educational content needed to prepare and develop the careers of medical communicators in pharmaceutical and biotechnology settings and to provide guidance on the development of new educational content. in 2020, joan received the amwa president’s award, and she has been a member of the board of directors since 2021. joan was also instrumental in conceiving and implementing the value of medical writing work group. this group has worked diligently to define and quantify the value of medical writing, producing numerous peer-reviewed publications in support of the medical writers’ role in the industry. joan has had an active role in shaping the evolution of medical writing over the last 2 decades, and her leadership has extended beyond amwa and her employers to help the field at large. she has served as an advisor to the healthcare businesswomen’s association and is a member of the university of virginia darden school of business leadership communication council. join amwa in congratulating joan when she receives her award this fall at the medical writing & communication conference in baltimore, md. the member awards recognition committee members were abbie miller, mwc (chair); loretta bohn, els (board of directors liaison); elizabeth brown, ms, pmp; joanne mcandrews, phd; christina barnes, msn, rn, cpnp-pc; jerm-day storms, phd, mwc; and susan aiello, dvm, els. diane noland served as staff liaison, and susan krug, ms, cae, served as ex officio. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: abbie.roth@nationwidechildrens.org abbie miller, mwc / 2022-2023 chair, member awards recognition committee 2023 harold swanberg distinguished service award recipient joan affleck, mba amwa news http://www.amwajournal.org v38 n1 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 51 q1: in the age of linkedin, how important is a website for a freelancer? what are the key elements that should be included in developing a website? initially, i thought my answer to this question would be quite brief: i don’t think websites are important for freelancers, since i’ve never had one yet have had a successful freelancing career. upon reflection and discussing this with other freelancers at a local amwa chapter event, i realize this answer is very specific to the type of writing i do and at this particular time in my career. i almost exclusively write educational materials for pharma/biotech sales representatives and medical science liaisons, none of which ever enter the public domain. although a website can include writing samples and links to published works that can be very helpful for many freelancers, i don’t have any samples or links that can be publicly shared. after 20+ years as a freelance medical writer, i feel like linkedin is currently a better way for me to market than a website. however, i can’t rule out that i missed out on great potential clients earlier in my career because i didn’t have a website. —gail v. flores although linkedin has become increasingly important for freelance medical writers and editors, you still need a website too. clients use linkedin to search for freelancers and also to check us out to decide whether to contact us. but you have to follow linkedin’s format for the content and design of your profile. a professional, client-focused website helps you stand out from other freelancers and persuade clients that you’re the right freelancer for them. your website highlights your key marketing messages in a compelling and visually engaging way and shows clients that you’re running a professional freelance business. the two key elements of a freelancer’s website are (1) content that’s compelling, clear, and focused on client needs and (2) design that’s visually engaging, clear, and easy to navigate. in your content, quickly tell clients • what you do (your services), • who you do it for (your target clients), and • how what you do benefits clients. if you already have a client-focused linkedin profile, then you should have much of the information you need for your web content. write client-focused marketing messages and conversational, concise, and scannable content. include the essential web pages for freelancers. use heads and subheads to highlight the benefits clients get when they work with you. heads and subheads also make your content concise and scannable. write your content like you’re having a conversation with a client. the essential web pages for a freelance website are • home (the most important part of your website), • about, • services, • samples, portfolio, or work, • testimonials, clients, or testimonials and clients, and • contact. you can combine and organize services; portfolio, samples, or work; and testimonials, clients, or testimonials and clients in different ways. if you’re a new freelancer, you can add testimonials and information about clients later. hiring a professional designer is one of the best investments in your freelance business you can make. if your design isn’t visually engaging, clear, and easy to navigate, then clients will move on to the other freelancers on their list. also, a good designer will guide you through the process of developing your website. —lori de milto * * * q2: what are your favorite web conferencing platforms and why? my favorite web conferencing platforms are gotomeeting and zoom. i like gotomeeting because it’s extremely userfriendly. i can easily split the window so that the meeting freelance focus melissa l. bogen gail v. floreslori de milto cathryn d. evans http://www.amwajournal.org amwajournal.org 52freelance focus slides are on one of my monitors and the meeting participants are on a second monitor. i can also quickly use the camera icon to take a screenshot of the slides being presented instead of having to manually take screenshots. however, to my knowledge at this time, the accessibility f eatures for gotomeeting are behind those for zoom; some of my colleagues have informed me that many screen readers are not compatible with gotomeeting, and the closed captioning feature is not as robust as the one used in zoom. for these reasons, i prefer zoom. i’m not a fan of either microsoft teams or google hangouts. although i use microsoft and google apps and platforms all day every day in my work, i find their web conferencing platforms to not be as easy to use as those discussed above. —gail v. flores other than skype and facetime, the only two web conferencing platforms i have used (or attempted to use) are zoom and ms teams. the latter was not compatible with my imac 27” desktop computer; the client’s it person tried three times to enable me to log on to ms teams, over the phone and within my computer—this person was not successful. the person said it is “supposed to be” compatible with mac but obviously wasn’t able to make it so. thus, i opted out of joining meetings via ms teams (which, being a microsoft product, is of course more compatible with ms windows than with mac). zoom, on the other hand, is simple and works easily on the desktop, ipad, and iphone. since the pandemic shutdown, i have participated in somewhere between 5 and 8 zoom meetings every week, except when out of town—with no complications. —cathryn d. evans * * * q3: what are the etiquette rules for web conferencing platforms that you follow? camera on or off and when? i’ll start by saying that i believe that nobody should ever feel like they have to be on camera. in addition to not being comfortable with being on screen, many valid reasons exist for not being on camera. personally, mine have included very early meetings, feeling unwell due to illness, and being upset after receiving bad news. it’s ok for people to have offscreen days—after all, in each meeting, there always seems to be at least one other person who is offscreen because they are traveling, driving, or their webcam has stopped working. furthermore, my projects went well for 20 years before the pandemic just through teleconference calls, so video isn’t a must for project success. however, there are also valid reasons for being on camera. i think it helps build a rapport with my clients, particularly during initial or project kickoff meetings. i also enjoy the social aspect; i often feel isolated working from home, and i enjoy interacting with others besides my family members, even if it’s just onscreen. with respect to etiquette, i believe that cameras should be off when people are eating or are using exercise equipment, such as a treadmill or stationary bike. wardrobe is up to each person. for me, i might wear something nicer for a new client and something more casual for someone i’ve known for a while or for an internal team meeting. finally, if you need to respond to an email from a client or a text from a family member, i recommend turning the camera off, since it’s difficult to hide that you’re not paying attention to the speaker. —gail v. flores for the most part, on-camera participation is something i do for only the first meeting with a particular group so that we all get to know one another and have a visual impression of one another; after that, i use an icon/photo when attending a zoom meeting. exceptions occur, but my general rule is to be off camera. obviously, the most important “etiquette” rule is to listen to others and pay attention just as dutifully as when you meet in person. second (especially when meeting on camera) it is simple courtesy and common sense not to eat, read other materials, leave the room unless absolutely essential, answer the phone and carry on a sideline conversation, or do anything that might be considered rude or untoward. drinking water, coffee, or tea seems to be acceptable. third, “mute” yourself when you are not actually speaking. finally, do not allow boisterous or barking dogs— or other potentially distracting background activities—to take place. —cathryn d. evans virtual meetings have become especially popular during the covid-19 pandemic. because web conferencing takes the place of in-person meetings, i dress and behave as if i’m in the room with my work colleagues. here are my best practices for virtual meetings: • wear business-casual attire, including shoes, in case you stand up and your legs or feet become visible. • ensure you have drinking water nearby so you don’t have to leave the meeting to get it. • blur the background to draw attention to your face and away from your surroundings. • absolutely no other people (eg, household members) should be visible in your background if they are not a http://www.amwajournal.org amwajournal.org 53freelance focus conference participant. if you cannot conduct the web conference in a dedicated space to ensure privacy and confidentiality, blurring the background is especially important. • keep the camera on and look at the speaker so it’s clear you’re paying attention. if it’s a small meeting and your clients have their camera off, you can turn your camera off to match them. i like to show my face at least initially so they know what i look like and that i am prepared to have our meeting. • if you need to move away from the camera—either quickly to close a door or window shade or longer for a bathroom break—turn the camera off temporarily so that walking away and coming back doesn’t distract the other participants. • in zoom (and perhaps other platforms), add a business-casual photo of yourself to your profile so it appears when the camera is turned off. using a photo is not essential, but this is a nice practice to keep some humanity in the virtual meeting. • as a label for your face or photo, use your complete business name and perhaps add your pronouns in parentheses. • keep muted except to talk. —melissa l. bogen unlock the secrets to freelance success with this 3-part on-demand video series. gain relevant and practical advice from industry pros. run your business like a pro. • essential ingredients of a successful freelance business • bad behaviors that can sabotage your business • getting the clients you deserve unlock now in amwa online learning: www.amwa.org/freelance_success http://www.amwajournal.org v38 n1 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 34 vee white vee white editorial, philadelphia, pa andrea klingler curtis learning llc, philadelphia, pa by eloise dehaan if i were to write this piece without crediting medical editor vee white and medical and science editor andrea klingler for their research and presentation, it would be plagiarism. the two shared their expertise about plagiarism at amwa’s medical writing & communication conference, november 3, 2022, in denver. plagiarism is “[when] an author documents or reports ideas, words, data, or graphics, whether published or unpublished, of another as [their] own without giving appropriate credit or attribution” (ama manual of style, 11th edition, section 5.4).1 between 2019 and 2020, white and klingler surveyed 260 writers, editors, and publishing professionals about plagiarism. the largest proportion of responses came from the united states, canada, and the united kingdom but included widespread places such as japan, cyprus, and uruguay. the survey found that writers fear plagiarism’s consequences most (figure). among 38 medical or science writer respondents, the largest proportion, 84%, thought the biggest consequence of plagiarism was that they would lose their job. gaps were obvious between how confident publishers were in writers’ and editors’ ability to produce plagiarism-free product and the confidence of editors and writers themselves to do so, with publishers being more skeptical. session report what is plagiarism? putting out fires around this hot topic conference figure. the plagiarist. cartoon reprinted with permission under a cc-by nc license from iva cheung.2 http://www.amwajournal.org amwajournal.org 35what is plagiarism? furthermore, among the subset of 79 medical/science communicators who were “extremely or very confident in their understanding of and their ability to avoid/identify [plagiarism], 26 (33%) had no or intentional-only training.”2 the presenters explained that intentional plagiarism is knowingly taking credit for someone else’s work. it is presenting someone else’s words, sentence, structure, or idea as your own. unintentional plagiarism is done without intention and can be the result of poor paraphrasing, careless work like forgetting to insert a citation, or cultural differences. publishers’ top tactic for avoiding plagiarism in new content was to put clauses about the issue into their contracts with writers (71% of publisher respondents chose this option). for catching plagiarism in existing content, publishers depended on an editor’s keen eye (82% of respondents) and plagiarism-detecting software (74%). although the survey respondents tended to be highly experienced in their occupation, most reported receiving training on this subject in an academic setting, some as far back as in grammar school. minimal anti-plagiarism training seems to be offered to writers and editors. with even less training in unintentional plagiarism, editors lack knowledge of this issue. editors do, however, implement specific strategies to identify plagiarism. white and klingler offer tips to help writers avoid plagiarism2: • keep copied verbatim text separate. • remember to cite public domain and unpublished material too. • summarize, analyze, and synthesize. • remember that plagiarism includes more than words. • be careful when reusing your own previously published material. they also counsel editors on how to help writers when plagiarism is an issue2: • prepare with concrete examples. • start the conversation with a different word. • ask questions. • avoid assumptions. • open discussion before deciding next steps. see the plagiarism survey project’s website at www.veewhite.com/plagiarism-survey. eloise dehaan is medical copyeditor and stakeholder engagement coordinator, horizon scanning, at ecri, plymouth meeting, pa. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: edehaan@ecri.org references 1. flanagin a. 5.4 scientific misconduct. in: ama manual of style: a guide for authors and editors. 11th ed. ama manual of style; 2020. doi:10.1093/jama/9780190246556.003.0005 2. the plagiarist. iva cheung. published 2022. https://ivacheung. com/2022/03/the-plagiarist/. accessed 19 january 2023. 3. white v, klingler a. what is plagiarism? putting out fires around this hot topic. presented at: medical writing & communication conference; november 2-5, 2022; denver, co. general principles of word usage www.amwa.org/online_learning choose the right word for accuracy and clarity. http://www.amwajournal.org http://www.veewhite.com/plagiarism-survey https://ivacheung.com/2022/03/the-plagiarist/ https://ivacheung.com/2022/03/the-plagiarist/ american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. v38 n2 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 36 the patient-physician relationship in the context of physician-targeted violence from the perspective of a medical student kevin a. wu / duke university school of medicine, durham, nc everyday ethics abstract the tragedy that transpired at a hospital in tulsa, ok, in june of 2022 highlights the issue of physician-targeted violence in the united states.1,2 the shooting in tulsa had occurred after a patient, dissatisfied with their back pain despite it only being 2 weeks after spinal surgery, attacked one of the few black orthopedic surgeons in america, dr preston phillips.1 dr phillips’ murder is not an isolated incident. in 2015, dr michael davidson, a cardiothoracic surgeon at brigham and women’s hospital in boston, ma, was shot and murdered by the son of a patient that the surgeon had operated on the previous year.3 dr davidson had spent a significant portion of time answering questions from the disgruntled son who would eventually murder him. the 2 tragedies, separated by over 7 years, center around physician-targeted violence. both surgeons had operated on a patient and were murdered as a result. both cases beg the question: what went wrong, and how could they have been avoided? these 2 cases represent examples of a greater trend of increasing violence toward physicians exacerbated by the covid-19 pandemic.4,5 figures from the us bureau of labor statistics estimate that the rate injuries from attacks against medical professionals grew by 67% from 2011 to 2018.6 us hospitals reported an increase in assaults and threats mirroring the global trend during the covid-19 pandemic.7 violence against physicians is symptomatic of a large issue: the deteriorating patient-physician relationship and the illusion of what the physician is. at the core of health care is the patient-physician relationship.8 four models of the physician relationship have been described.8,9 the paternalistic relationship has the physician creating decisions on behalf of the patient. the interpretive relationship requires a physician to figure out a patient’s goals and values and subsequently offer options to achieve them. an informative relationship has the physician providing information and allowing patients to decide for themselves. finally, in a deliberative relationship, the physician and patient collaborate as equals and work together to achieve a goal. historically, the paternalistic model predominated, in which the physician’s main duty was seen to protect patients even at the expense of their autonomy.10 this has contributed to the expectations that physicians are miracle workers and if they fall short, they should be blamed. in line with a paternalistic model, physicians often avoid talking about poor prognoses to be protective or kind; however, research shows that patients end up feeling isolated with their concerns, and the inability to discuss poor outcomes adds to the illusion of perfectionism.11,12 the paternalistic model has contributed to the deterioration of the patient-physician relationship by disrupting communication for the sake of the patient. part of the problem has been the portrayal of physicians by the media.13 physicians are seen as wanting to maximize profits, seemingly pushing medications unnecessarily.14 historical events have contributed to that perception. in the past, the medical field acted against the best interest of already marginalized patients through experiments like the tuskegee syphilis study conducted from 1932 to 1972, which withheld vital treatment from black men diagnosed with syphilis.15 actions to correct the matter only took place after it had come to light, resulting in regulations requiring researchers to obtain voluntary informed consent and the institutional review board’s approval.16 historical events have created a gap between specific marginalized populations and physicians. although institutional change is necessary to bridge the mistrust that exists within marginalized communities, individual physicians and medical students can take steps to help address the issue. physicians can start at the bedside by showing that they want the best for patients, and breaking down mistrust begins at the medical education level.17 understanding the historical origins and source of the mistrust would provide context to physicians in navigating interactions with patients. physicians use a historical lens to understand the decisions of patients and allow that http://www.amwajournal.org amwajournal.org 37patient-physician relationship in the context of physician-targeted violence knowledge to guide their responses. decreasing the amount of discrimination experienced by patients would minimize the mistrust felt by patients and work to support the idea of physicians as true patient advocates. physicians can begin to decrease the amount of discrimination through removing stigmatizing language in patients’ medical records that end up influencing future interactions.18 similar to how one negative experience can paint a patient’s view of future interactions, a positive one can create a favorable view of the medical field. over time, the accumulation of positive interactions would go a long way to mend the general patient-physician relationship. trust remains low in the general population, partially a result of the affordability of health care and the lack of transparency in decisions made.19 this perception of the physician has contributed to an “us versus them” mentality between the patient and physician. no longer are physicians seen as always doing the best for the patient.13,14 decisions are analyzed through the lens of potential ulterior motives. likewise, patients who end up distrusting their physicians are labeled as “noncompliant” even if they have legitimate reasons not to trust them. the relationship has been strained in both directions.20 the way the health care system is built up does not help the issue. physicians have limited time with each patient.21 the lack of time has fed into the discontent felt by many patients. and so, when the health care system fails to meet the needs of the patient, it is the physician who is blamed. fixing the issue remains a complex and convoluted process that requires moving away from a paternalistic model toward a more deliberative relationship that encourages partnership between physician and patients. first, change needs to occur at the level of medical education. students should not be discouraged to broach conversations surrounding failure.22 a degree of perfectionism is required to make it to medical school, but it is important to allow medical students to fail. fostering an environment where students can learn from their mistakes would go a long way toward removing the veil of perfectionism. students and medical professionals should be encouraged to approach tough conversations about prognoses earlier rather than later. physicians often feel inadequate in their training conducting these conversations, and starting from medical school would work to alleviate that.23 research shows these conversations do not harm patients and potentially strengthen the relationship between physicians and patients.12,24 through discussions, patients will eventually realize that physicians, although trying their best, are not miracle workers. when failure arises, there should be steps to prevent it from occurring again; however, normalizing failure would allow patients to understand that it is a possibility. relationships go two ways. patients need to realize the limitations that exist in medicine. the success of a procedure or diagnosis depends on numerous factors. fostering a deliberative relationship model and allowing discussions of failure would work to allow patients to recognize that. ultimately, physicians have limitations. medicine is a science, not a miracle, even though it may seem like it at times. the issue can only be resolved as patients realize that physicians are on their side, and that requires a mindset shift with the public. as america once again deals with another tragedy, the medical field needs to work to address the discontentment. creating an environment that strengthens the patient-physician relationship is essential to ensure that these tragic events do not happen again. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: kevin.a.wu@duke.edu references 1. bunn c. black doctors mourn tulsa hospital shooting victim dr. preston phillips. nbc. june 4, 2022. accessed june 9, 2022. https://www.nbcnews.com/news/nbcblk/black-doctors-mourntulsa-hospital-shooting-victim-dr-preston-phillips-rcna31846 2. ha jf, longnecker n. doctor-patient communication: a review. ochsner j. 2010;10(1):38-43. 3. sweeney c. the murder in exam room 15. boston magazine. june 30, 2015. accessed june 8, 2022. https://www.bostonmagazine. com/news/2015/06/30/brigham-and-womens-hospital-shooting/ 4. caruso r, toffanin t, folesani f, et al. violence against physicians in the workplace: trends, causes, consequences, and strategies for intervention. curr psychiatry rep. 2022;24(12):911-924. doi:10.1007/s11920-022-01398-1 5. devi s. covid-19 exacerbates violence against health workers. lancet. 2020;396(10252):658. doi:10.1016/s0140-6736(20)31858-4 6. injuries, illnesses, and fatalities. us bureau of labor statistics. published 2022. accessed january 12, 2023. https://www.bls.gov/ iif/home.htm 7. dyer o. us hospitals tighten security as violence against staff surges during pandemic. bmj. 2021;375:n2442. doi:10.1136/bmj.n2442 8. olejarczyk jp, young m. patient rights and ethics. in: statpearls. statpearls publishing; 2022. 9. emanuel ej, emanuel ll. four models of the physician-patient relationship. jama. 1992;267(16):2221-2226. doi:10.1001/ jama.1992.03480160079038 10. kilbride mk, joffe s. the new age of patient autonomy: implications for the patient-physician relationship. jama. 2018;320(19):1973-1974. doi:10.1001/jama.2018.14382 11. mack jw, smith tj. reasons why physicians do not have discussions about poor prognosis, why it matters, and what can be improved. j clin oncol. 2012;30(22):2715-2717. doi:10.1200/ jco.2012.42.4564 12. geerse op, lamas dj, sanders jj, et al. a qualitative study of serious illness conversations in patients with advanced cancer. j palliat med. 2019;22(7):773-781. doi:10.1089/jpm.2018.0487 13. rimmer a. why are more patients complaining about their doctors? bmj. 2014;349:g4839. doi:10.1136/bmj.g4839 14. armstrong k, rose a, peters n, long ja, mcmurphy s, shea ja. distrust of the health care system and self-reported health in the http://www.amwajournal.org https://www.nbcnews.com/news/nbcblk/black-doctors-mourn-tulsa-hospital-shooting-victim-dr-preston-phillips-rcna31846 https://www.nbcnews.com/news/nbcblk/black-doctors-mourn-tulsa-hospital-shooting-victim-dr-preston-phillips-rcna31846 https://www.bostonmagazine.com/news/2015/06/30/brigham-and-womens-hospital-shooting/ https://www.bostonmagazine.com/news/2015/06/30/brigham-and-womens-hospital-shooting/ https://www.bls.gov/iif/home.htm https://www.bls.gov/iif/home.htm amwajournal.org 38patient-physician relationship in the context of physician-targeted violence united states. j gen intern med. 2006;21(4):292-297. doi:10.1111/ j.1525-1497.2006.00396.x 15. freimuth vs, quinn sc, thomas sb, cole g, zook e, duncan t. african americans’ views on research and the tuskegee syphilis study. soc sci med. 2001;52(5):797-808. doi:10.1016/s02779536(00)00178-7 16. the u.s. public health service syphilis study at tuskegee. centers for disease control and prevention. reviewed january, 24, 2023. accessed january, 24, 2023. https://www.cdc.gov/tuskegee/index. html 17. ufomata e, merriam s, puri a, et al. a policy statement of the society of general internal medicine on tackling racism in medical education: reflections on the past and a call to action for the future. j gen intern med. 2021;36(4):1077-1081. doi:10.1007/ s11606-020-06445-2 18. park j, saha s, chee b, taylor j, beach mc. physician use of stigmatizing language in patient medical records. jama netw open. 2021;4(7):e2117052. doi:10.1001/jamanetworkopen.2021. 17052 19. baker dw. trust in health care in the time of covid-19. jama. 2020;324(23):2373-2375. doi:10.1001/jama.2020.23343 20. chang s, lee th. beyond evidence-based medicine. new engl j med. 2018;379(21):1983-1985. doi:10.1056/nejmp1806984 21. tai-seale m, mcguire tg, zhang w. time allocation in primary care office visits. health serv res. 2007;42(5):1871-1894. doi:10.1111/j.1475-6773.2006.00689.x 22. gorini a, miglioretti m, pravettoni g. a new perspective on blame culture: an experimental study. j eval clin pract. 2012;18(3):671675. doi:10.1111/j.1365-2753.2012.01831.x 23. daugherty ck, hlubocky fj. what are terminally ill cancer patients told about their expected deaths? a study of cancer physicians’ self-reports of prognosis disclosure. j clin oncol. 2008;26(36):5988-5993. doi:10.1200/jco.2008.17.2221 24. fenton jj, duberstein pr, kravitz rl, et al. impact of prognostic discussions on the patient-physician relationship: prospective cohort study. j clin oncol. 2018;36(3):225-230. doi:10.1200/ jco.2017.75.6288 www.amwa.org/knowledge_builders knowledge builders build your knowledge on a specific medical communication topic through a variety of elements designed to create an engaging educational experience. listen to a narrated slide set engage in exercises access the handout review the reading list note what you learned explore amwa online learning and get ready to l.e.a.r.n. http://www.amwajournal.org https://www.cdc.gov/tuskegee/index.html https://www.cdc.gov/tuskegee/index.html v38 n4 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 27 abstract medical device development requires regulatory documentation, but what constitutes good writing in those documents has no well-established pedagogy. senior regulatory experts often use the language of storytelling when asked what makes for good regulatory writing. twelve such senior experts interviewed for this article responded with some version of, “it all depends on how you tell your device’s story.” but what does this claim really mean? regulatory documents are long and technical; they are not usually considered in literary terms. this article explains how storytelling can help hone your regulatory writing. it uses the literary components of setting, plot, and character to show how selecting contextual details, tightening causal connections, and keeping the focus improve document quality. furthermore, it employs real life examples taken from the fda and notified body submissions to illustrate exactly where and how those details, connections, and focuses contribute to good storytelling. key transitional phrases, syntactical constructions, and relevant contextual data make all the difference. successful medical device development involves truckloads of documentation, from design control records to clinical literature to post-market surveillance. yet none of these documents are accompanied by as much handwringing as the device’s regulatory submissions. years and years of work hang suspended by the thread of a single submission packet. will the fda approve it? will it be ce marked? curiously, little training is associated with the specific writing skills that such vital regulatory documentation demands. the early twentieth-century boom in engineering birthed an entire profession of technical writers. medical writers can attend specialized graduate programs at a number of universities. yet outside a smattering of individualized courses or certificate programs, the regulatory field has no commensurate area of professionalized writing expertise, even though degrees in medical device regulation abound. is document quality inconsequential to regulatory agencies? in 2014, medical writing devoted 2 different issues to argue the contrary.1,2 more recently, survey results published by the amwa journal in 2021 demonstrate the value of good regulatory writing: 87% of the regulatory reviewers surveyed claimed that poor writing impedes their assessment.3 this lack of a distinct professionally adjacent writing field may be due to the strict stipulations regulatory agencies provide. major medical device manufacturers have company templates for what to write. technical understanding of the product and its relationship to the clinical field and current state of the art is likely more important than the quality of a submission’s prose. yet the amwa’s 2021 survey demurs. moreover, when you talk to longtime regulatory insiders who have worked for the fda or notified bodies, they tend to stress the writing. in my experience, when you ask these experts what makes for successful regulatory submissions, they answer with some version of, “it all depends on how you tell your device’s story.” regulatory experts frequently stress the importance of storytelling, which i soon realized as i collaborated with them. (a benefit of working at a clinical research organization is the exposure you get—not only to multiple devices but high levels of expertise.) the first time i heard it was from a senior colleague who had worked at the fda for decades. i was helping to draft part of a pre-submission letter to the fda. “remember,” i was counseled, “it’s all about the story we’re telling.” a few days later, it popped up from another ex-fda employee in a similar circumstance. then, in the middle of a large meeting, i heard a consultant who used to work with a notified body insist, “we must help our clients to tell their device’s story well—that is crucial!” medical device regulation is a highly technical field— it demands familiarity with the precise terminologies used in medicine, engineering, and law. why were these technically proficient industry insiders talking about stories? it struck me as strange. story is, after all, a catchall type of term. it’s amorphous, applying as much to a novel as a painting, as much to an advertisement as a lie. storytelling belongs in the dusty corners of coffee shops, not brightly lit biomedical engineering labs. yet it was near ubiquitous advice: tell your device’s story, they said, over and over again. scott dill, phd / namsa, minneapolis, mn the key to better regulatory writing: tell your device’s story topical feature http://www.amwajournal.org amwajournal.org 28the key to better regulatory writing: tell your device’s story many universities offer courses in “medical humanities,” a field that harnesses the power of narrative to explore how humans experience medicine. story is essential for how that field understands medical practice and can overlap with the concerns of technical communicators.4 yet these regulatory experts didn’t mean anything close to the medical humanities. they meant story as an organizing principle, not an encounter with the humanities. i began interviewing 12 senior regulatory experts to understand what they meant by storytelling, asking them pointed questions to draw it out as exactly as possible. what follows in this article uses their terminology’s literary sensibility, only amplified with particulars extrapolated from their generalities. setting, plot, and character encompass the practices necessary for good medical device storytelling. establish the context: setting you’ll often hear novelists say they long to provide a distinct sense of place. near the beginning of her essay “place in fiction,” eudora welty claims that a novel’s sense of place determines its quality.5 beyond a lofty goal, however, she notes that fiction is structurally “all bound up in the local.” place, or the setting of a story, is crucial to how it works. the setting gives a story its feel, its sense of completion. setting makes a story believable. good storytelling means providing the appropriate amount of context. this was usually the first thing a person said when i asked them how to tell a device’s story: “provide enough context—but not too much!” too many details overwhelm; strive for the right ones. although the reviewers who read regulatory submissions often have impressive technical backgrounds, they will likely know little about your device. they won’t know how your device was developed or how it fits into a specific medical field. prejudices from previous experiences might incline them to make unhelpful assumptions about your device. it’s your job to preempt such misunderstandings. your ability to put the device in the appropriate setting makes your submission believable. a couple of practices can help make this happen. first, do not make the mistake of assuming executive summaries and conclusions are unimportant textual padding. make use of these sections. if you’re using boilerplate language instead of crafting these key passages to convey the appropriate context, you’ve thrown away a vital chance to communicate with your reviewer. second, pay attention to phrasing. adding helpful contextual details to frame your claims and data will create the right setting. below is a paragraph taken from a pre-submission letter to the fda (altered, with data and references removed). it is meant to provide an example of how attention to phrasing establishes helpful context. the underlined phrases below provide background to situate the data in the device manufacturer’s deliberately selected setting. in brief, the goal was to clarify how an off-label procedure (in the us) was safe and had clinical data, although from elsewhere. other us surgeons are employing off-label procedures to address the need for a more unified approach to heavily calcified disease extending into the aorta. in a special issue for endovascular now, the new york-based vascular surgeon john smith explains his preference for “advanced treatment of lengthy aortic disease with a covered endovascular reconstruction of the aortic bifurcation (cerab) technique for complex aortic disease.” dr smith’s preference is rooted in data now familiar to vascular surgeons. published studies comparing standard endovascular treatment, cerab, and open surgery found higher 30-day mortality rates, but better medium-term patency with open surgery compared to the endovascular techniques [hard data here.] due to its recent development, long-term data is not yet available for cerab techniques. note how the writer contextualizes the opening sentence with what came before—we can infer that the previous paragraph discussed the views of us surgeons. beginning with “other us surgeons” establishes the critical context for the paragraph: we’re still talking about the us and its surgeons. that’s what’s often called a “signal term.” the surgeon quoted in the second sentence is placed in a us city. does the city in which this doctor practices matter? not really. but us practices and the us population matter for the fda, and we want to remind the readers that this comes from us-based surgeons’ opinions. this provides a meaningful context to interpret the safety and performance data that closes the paragraph. finally, note the last underlined phrase. “due to its recent development” puts the finishing touch on the setting. setting is about place; yes, certainly. it’s also about time. we want to know when something took place. the timing matters, too. the data are put into a chronological history of medical developments. taken together, these small additions create an interpretive framework for the reviewer. keep the thread: plot the british novelist e. m. forster once said, “‘the king died and then the queen died’ is a story. ‘the king died and then the queen died of grief’ is a plot.”6 plot, in forster’s famous formulation, provides the causal relationship between events in a story. the king’s death and the queen’s death are simple events. we can tell the story of when, where, and how they happened. but for that story to have a plot http://www.amwajournal.org amwajournal.org 29the key to better regulatory writing: tell your device’s story we must answer why. the king’s death causes the queen’s death—she died “of grief.” see how the event now takes on a causal relationship? something made her death happen: the queen died of grief. that’s what we want in a plot—we want clear causal connections. regulatory documentation keeps its plot thread by drawing out causal connections. almost everyone i interviewed emphasized keeping a sense of connection at various levels: between claims and data, between arguments, and between sections. this even applies to long documents, such as the clinical evaluation reports required as part of marketing submission to the european union. if explicit connections are missing and the reviewer struggles to follow your case, you’ve opened the door to doubt. an auditor or reviewer could give up in frustration and write you off as unprepared. or they might begin to wonder—how does this relate to such and such? soon they will start to wonder what you’re not saying. are you overlooking something or—worse—hiding something? a lack of clear causal connections can erode your authority and invite counterarguments that might never have arisen with tight transitions between points. one straightforward way to think of this is, don’t skip the rationales! robust rationales are critical to communicating the logic behind design changes to the concerned regulatory agency. the basic principle of providing robust rationales—explaining why something changed instead of simply glossing over how it changed—can be broadly applied to all the claims you make in your documentation. other strategies can help you keep your causal connections clear. first, signal the beginning, middle, and end with signal terms such as first, second; after, before; etc. this provides a sense of order. second, use transition words that make the causal relationship between sentences clear. keep the plot going with words like another, yet, while, furthermore, etc. third, remind the reader of the overall arc of the document and how this particular point relates to the overall point. for example, the state of the art section in a clinical evaluation report, which often feels forced and out of place, should be linked back to the rest of the document. that section places your device in the context of relevant treatments. do so! fourth, we were all taught to use topic sentences, but how consciously do we do so when using a template for regulatory documents? yet those topic sentences provide the logical connections between your main points. they provide roadmaps to what is coming and how that point connects to what came before. topic sentences keep the reader engaged—on the writer’s terms. additionally, the logical connections in your prose should go even deeper than topic sentences and transition terms. the way each sentence links up with the following sentence is a simple way to keep your logical connections tight. think in terms of the grammatical logic of subjects and predicates. usually, the predicate presents the information that needs to be communicated about the sentence’s subject. if you consider your sentences as proceeding from a familiar subject to a new predicate, your prose will keep its logical connections rooted in its grammar. the example below is from a clinical literature review on a device used during high-risk percutaneous interventions. this short paragraph explains how the indication of high risk has a unique history that matters for understanding how the device in question works. although this paragraph does not reference the device, it connects each sentence to the following through the logic of its grammar. the paragraph opens with a historical claim and ends with a justification for the increased vulnerability of the relevant population. as you read through it, note how the subject in bold font links back to the underlined predicate preceding it. percutaneous coronary interventions (pcis) now carry less risk than they did nearly half a century ago, when the procedure was first introduced. all pci patients who were considered “high risk” (hr) patients early in the procedure’s development. back then, procedural success was <60% and a cardiothoracic surgeon was required to be in the operating room. procedural success is now nearly 100% and the definition of hr-pci has now focused on a specific subset population. specifically, patients who are hr-pci typically present with unprotected left main coronary artery, multivessel, and bifurcation lesions, as well as those with chronic total occlusions. such conditions are indeed “high risk.” english usually begins sentences with the subject of the sentence and then introduces some new information about that subject in the predicate, the second part of the sentence, which is often a verb or verb phrase. regulatory documents should be written in what is called plain english (or sometimes, global english), whether they’re for a notified body or the fda. plain english is simplified and strives to be nonidiomatic. thinking about the basic subject-predicate structure of your sentences can help produce the clarity associated with this style. more to the point, it will help you keep the plot by tightening your writing’s causal connections. maintain focus: character another way to tell your story well is to develop key characters. who’s at the center of your story? how will you keep the reader’s focus on that main character? in the data dump of technical specifications and clinical findings, it can be easy http://www.amwajournal.org amwajournal.org 30the key to better regulatory writing: tell your device’s story to lose focus. the true protagonist in every regulatory document is the patient. remember, each piece of data you pull into your writing represents an actual human being. real people hide behind your statistics. the point behind developing new medical devices is, after all, to help people! the reviewers at regulatory agencies are there because they want to help people—both by keeping them safe and enabling new developments. don’t become careless in your tone or terminology such that your writing loses that human focus. other types of character inhabit regulatory documents. the device in question may be your focus, but related alternative treatments are key to how readers perceive its value. take the following review of the current state of the art for stenting. example #3 below is taken from the state of the art section of a clinical evaluation report on a guidewire device. stenting, not any specific stent, is the character being developed here. as you read through it, note that we are told why stents are employed over other procedures and why new stents have developed over time. a meaningful pattern has been presented here: a pattern that creates the story of stenting. note how the information is being interpreted for us so that we keep the focus on the stenting. finally, notice how the underlined text explains the value of the nearby claim (in bold text). sometimes the claim in bold text comes first, as in the first sentence, and sometimes it follows the explanation. but the sentences are built to focus on stenting while developing and enlarging what that entails. stenting: today, two main types of bare-metal stents are available: self-expanding stents and balloon-expandable stents. because of the technical limitations of self-expanding stents, and their tendency to provoke greater neointimal hyperplasia, balloon-expandable stents are now used for nearly all coronary stent procedures. covered stents are most frequently used to treat emergent coronary perforations. as restenosis is a significant problem with bare-metal stents, drug-eluting stents were designed with immunosuppressant or cytotoxic drugs to inhibit neointimal hyperplasia. the risk of very late events associated with the implantation of permanent metallic stents (eg, stent thrombosis and restenosis, fracture) led to the development of fully bioresorbable stents, more commonly known as bioresorbable scaffolds. this is only an example, one way of thinking about how to keep your focus. nevertheless, it demonstrates the value of explaining your claims and how this simple rhetorical practice helps clarify the paragraph’s focus. paying attention to sentence construction, as this writer has done, gives the reader a clear sense of how stenting has developed. conclusion the goal of this article has been to distill insights gleaned from a group of experienced regulatory experts on why they value good storytelling so highly. although they often used literary terminology, it was unclear what that meant for them in practice. however, if you establish the context or setting for the device, keep the causal connections clear, and maintain focus on key characters, you’ll be off to a good start. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: scottddill@gmail.com references 1. morley g. regulatory writing basics. med writ. 2014;23(2):81-82. doi:10.1179/2047480614z.000000000191 2. chamberlain-james l. post-approval regulatory writing. med writ. 2014;23(4):257. doi:10.1179/2047480614z.000000000256 3. cooper j, chamberlain james l, affleck j, bass b, forjanic klapproth j, harris d. value of medical writing: the regulator’s perspective. amwa. 2021;36(4):145-151. doi:10.55752/ amwa.2021.83 4. angeli el, johnson-sheehan r. introduction to the special issue: medical humanities and/or the rhetoric of health and medicine. tech commun q. 2018;27(1):1-6. doi:10.1080/10572252.2018. 1399746 5. welty e. place in fiction. in: stories, essays, and memoir. library of america, 1998. 6. forster em. aspects of the novel. harcourt brace & co., 1927. http://www.amwajournal.org american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. v38 n3 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 43 the pandemic, he was instrumental in helping the chapter transition to zoom meetings for networking events, and he and the other attendees learned how to use the breakout room feature together. at the delaware valley’s in-person chapter conference this year, don organized a panel discussion on training the next generation of medical writers. don has also served on several committees at the national level, including the certification task force. when i reached out to don to congratulate him on receiving this award, he said, “i would just like to remind readers (including myself!) of what we already know: amwa is a wonderful, well-built organization, and its future will be what we make it. our profession depends on people helping people, and not always in ways that yield direct financial benefits. if we give generously, amwa will gain strength, and we will all benefit. if we withhold our gifts, amwa will weaken, and we will all suffer. so, let’s all encourage each other to keep volunteering and giving back to our profession through amwa. we’ll be glad we did!” i couldn’t agree more. thank you, don, for your passion for cme, your expertise, and your support of amwa. it is my pleasure to present don with this well-deserved honor for his contributions to amwa and to the medical writing and editing profession at large. please join me in congratulating don as this year’s president’s award recipient. amwa news 2023 president’s award recipient don harting, ma, ms, els, chcp elise eller, phd / 2022-2023 amwa president the recipient of the president’s award is selected by the amwa president, and each year this award is bestowed upon a member of amwa who has made distinctive contributions to the association at the chapter or national level. i am honored to recognize don harting, ma, ms, els, chcp, as the recipient of the 2023 amwa president’s award. don is a professional medical writer with master’s degrees in journalism and biology, 20 years of experience in print journalism, and 15 years of experience in continuing medical education (cme) writing. he is also a board-certified editor in the life sciences (els) and a certified health care cpd professional (chcp). don is the president of harting communications llc and specializes in developing needs assessments for education grant proposals and instructional content for accredited continuing education in the health professions. since 2008, he has worked with many accredited cme providers as well as nonaccredited medical education companies to win more than $4.8 million in education grants, mostly in oncology. a dedicated cme professional, don has published original, collaborative research on best practices for writing needs assessments and shared his results in the amwa journal and as posters, workshops, and a mini-tutorial for amwa members. currently, don and several collaborators are developing the first-ever competency model for the next generation of medical writers who wish to excel in developing content for continuing education in the health professions. the new cme writers’ competency model will be presented at this year’s medical writing & communication conference in baltimore. a member of amwa since 2007, don has been involved in the delaware valley chapter in a variety of roles and currently serves as programs chair. he notes that during http://www.amwajournal.org v38 n3 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 4 theme article abstract in today's globalized world, translating scientific and medical content is vital to bridging language barriers and facilitating communication among diverse audiences. this article dives deep into the importance of medical translation and provides key best practices to ensure accurate and high-quality translations. effective medical translators must possess strong writing skills in both the source and target languages to accurately convey the intended message while maintaining the tone and style of the original document. developing and finalizing content in one language before translation streamlines the process and enhances the quality of the translation. translators should seek clarification and ask questions during the translation process to deliver an error-free final version. understanding medical terminology in both source and target languages is crucial, and staying updated with the latest terminology is essential for accurate translations. utilizing a bilingual glossary or creating one in collaboration with the client helps ensure translation accuracy. although machine translations have limitations, computer-assisted translation tools like trados, memoq, wordfast, and omegat improve efficiency and consistency. these tools, equipped with translation memory and terminology management features, support human translators in their work. medical translation plays a significant role in global medical communication, alongside regulatory writing, scientific publications, health communication, professional education, promotional writing, and grant writing. it is essential for effective communication and accurate information exchange in the scientific community. in conclusion, accurate medical translation is crucial for effective communication and collaboration in the global scientific community. adhering to best practices ensures precise and high-quality translations, facilitating the sharing of scientific knowledge across languages. in today's globalized world, the need for accessible scientific and medical content is more important than ever before. in order to ensure that this information is available to a wider audience, including those who do not speak the same language as the original content, it is crucial to translate it. this can help bridge language barriers and facilitate communication among scientists, medical professionals, policymakers, educators, and the general public. translating scientific content would be needed by individuals or organizations who want to communicate scientific and/or medical information to a diverse audience that speaks different languages. some specific examples include 1. researchers or scientists who want to publish their research findings in international journals or conferences and want to make their research accessible to a wider audience. 2. science communicators who want to disseminate scientific information to the general public through various media channels such as websites, blogs, podcasts, or social media, and want to reach a broader audience. 3. science-based industries or organizations such as pharmaceuticals, biotechnology, or environmental consulting firms who need to communicate scientific information to clients, stakeholders, or regulatory bodies in different regions of the world and want to provide multilingual content to facilitate understanding and compliance. hence, medical translation is an essential component of global health care communication.1 however, dr mao, who is a bilingual chinese medical communicator leading acurit medical communications, believes that it is not as straightforward as it may seem. acurit is focused on medical translations between english and chinese, therefore dr mao led her team to translate the “amwa-emwa-ismpp joint position statement on medical publications, preprints, and peer review” from english to chinese. dr mao, who also serves on the executive board of the australia china business council, believes that medical translators must adhere to amanda xiaoqing mao, phd, cmpp1 and ishani thakkar, phd / 1acurit medical communications, melbourne, australia; 2boston, ma lost in translation: the vital role of medical translation in global medical communication http://www.amwajournal.org amwajournal.org 5the vital role of medical translation in global medical communication several best practices to produce accurate, high-quality translations. medical translation may involve the translation of various medical documents, including clinical trial protocols, patient information leaflets, regulatory documents, medical device manuals, and research papers, among others. although the types of documents to be translated are as diverse as those in medical writing, this article focuses mainly on medical translations targeting professional audiences. a good translator is also a good writer if a project requires translation, a translator must be good not only at writing in the target language but also comprehending the source language. if they are required to translate in both directions, then they should be good writers in both languages. they must be able to convey the intended message accurately while maintaining the tone and style of the original document. the aim is for the translated document to flow naturally, and for a third person to not be able to tell if it is a translation or original writing. this is only possible if the translator can produce good writing independently. translators should actively work on their nonnative languages, and writing helps strengthen their language skills. finalizing content in one language first in order to ensure high-quality medical translations, it is best to develop and finalize content in one language before translating it into another language. this streamlines the process and ensures quality. avoid developing content in both languages simultaneously. the choice of language for developing original content should depend on available medical writing resources and reviewer language preferences. a highly competent translator can ensure effective translation of complex messages such that the translated content appears to be produced in the target language. timing your queries appropriately indeed, the translation process is very distinct from manuscript writing or any other kind of medical writing. translators are expected to deliver one and only one translation, so they must prioritize delivering a final version that is ready for immediate use instead of taking the multiple-draft approach. in order to deliver an error-free translation that meets the client’s expectations, the translator should seek clarification and ask questions during the translation process, and not bombard the client with questions when the final translation is expected. questions regarding individual word choices are expected during translation, unlike in other kinds of medical communication in which the entire document may need to be reviewed for context before further clarification. the mark of a good translation is minimal corrections at the end from the client’s side. getting medical terminology right medical documents are often complex and contain technical jargon, making them difficult for nonmedical professionals to understand. therefore, a medical or life sciences background will greatly help a medical translator to accurately translate technical documents. more importantly, a thorough understanding of medical terminology in both the source and target languages is crucial in the translation process. medical translators must also make efforts to stay updated with the latest medical terminology. poor translation quality often results from incorrect translation of terminology. asking the client to attach a bilingual glossary before the process or inquiring for clarification on terminology during the process can help produce high-quality medical translations that meet client expectations. if the client does not have a bilingual glossary, an experienced medical translator may help produce one during the first project and expand it when future projects come in from the same client. to that end, authoritative sources in languages including but not limited to english include health and medical textbooks and scientific journal articles. regulatory bodies in countries such as china, where the official language is chinese, provide excellent resources in official medical terminology. websites for organizations such as the world health organization also have official languages in addition to english. such content can be very useful for looking up standard medical terminology. machine translations versus computerassisted translation although machine translations may be an effective way to do some preliminary work, a human is always needed to edit and finalize a translation, especially in terms of medical terminology, tone, flow, and context.2 however, using machines to translate medical and/or regulatory documents pose a bigger challenge than a lack of accuracy or flow.3 using online translation tools is not recommended for sensitive medical documents as it may put privacy and confidentiality at risk: an undesirable outcome in the life sciences industry. that being said, machine translation must not be confused with computer-assisted translation (cat) tools designed to help translators with repetitive tasks and improve efficiency. using translation tools like trados, memoq, wordfast, and omegat is encouraged. these software tools assist human translators in translating written content between languages. they include features like translation memory and terminology management to improve speed and accuracy while ensuring consistent http://www.amwajournal.org amwajournal.org 6the vital role of medical translation in global medical communication terminology use. cat enhances the work of human translators, allowing them to focus on complex and creative aspects while delegating routine tasks to the computer. medical translation is a form of medical communication based on the above information, the complexity and significance of the medical translation process in global medical communication are indisputable. according to the american medical writers association, there are 6 major categories of medical communication deliverables:4 1. regulatory writing 2. scientific publications 3. health communication 4. education for professionals (continuing medical education or cme) 5. promotional writing 6. grant writing but it is important to recognize that medical translation is an additional crucial component of medical communication: in conclusion, translating medical content is essential for effective communication and collaboration in today's globalized scientific community. whether it is a part of the final deliverable or simply a behind-the-scenes aspect of the project, medical translation is a necessary step to ensure effective communication and accurate information exchange between international scientific entities. acknowledgment we thank elizabeth kukielka, pharmd, mwc, cmpp, for enabling this collaboration. author declaration and disclosures: acurit medical communications does medical translation between english and chinese. it is a revenue-generating activity for the company. ishani thakkar notes no commercial associations that may pose a conflict of interest in relation to this article. amanda mao served as the subject expert for this article and ishani thakkar served as the writer. author contact: amanda.mao@acuritmedcomms.com, thakkar.ishani@yahoo.com references 1. mantry a. the importance of language translation in healthcare. translate by humans. published june 28, 2018. accessed april 28, 2023. https://translatebyhumans.com/blog/translation-inhealthcare/ 2. fairman g. applications of translation technology in healthcare. bureau works. published 2023. accessed april 28, 2023. https:// www.bureauworks.com/blog/applications-of-translationtechnology-in-healthcare-fc 3. wetsman n. google translate still isn’t good enough for medical instructions. the verge. published march 9, 2021. accessed april 28, 2023. https://www.theverge.com/2021/3/9/22319225/googletranslate-medical-instructions-unreliable 4. what types of medical writing are there? american medical writers association. published february 3, 2020. accessed april 28, 2023. https://blog.amwa.org/what-types-of-medical-writingare-there a career in medical communication: steps to success learn about the skills and attributes needed to be a successful medical communicator and discover opportunities in the field. www.amwa.org/career_steps http://www.amwajournal.org https://translatebyhumans.com/blog/translation-in-healthcare/ https://translatebyhumans.com/blog/translation-in-healthcare/ https://www.bureauworks.com/blog/applications-of-translation-technology-in-healthcare-fc https://www.bureauworks.com/blog/applications-of-translation-technology-in-healthcare-fc https://www.bureauworks.com/blog/applications-of-translation-technology-in-healthcare-fc https://www.theverge.com/2021/3/9/22319225/google-translate-medical-instructions-unreliable https://www.theverge.com/2021/3/9/22319225/google-translate-medical-instructions-unreliable https://blog.amwa.org/what-types-of-medical-writing-are-there https://blog.amwa.org/what-types-of-medical-writing-are-there amwajournal.org 56communicating science to the public communicating science to the public speaker susan e. aiello, phd, dvm, els / wordsworld consulting, townsend, tn by katherine feemster, mph as medical writers, we have a responsibility to our audiences to provide scientifically sound and readily understandable information. that role is often a difficult one to navigate—not only is it fraught with potential pitfalls, but it is also one of enormous responsibility. dr susan aiello gave a presentation focused on this responsibility at the amwa regional conference in fort meyers, florida, this past june. “communicating science to the public” shed light on those intricacies and the importance of the role medical communicators play. to begin with, medical writers should ask themselves a series of questions: • on a philosophical level: why can this be so hard? well, we all have diverse backgrounds, with varying educations, interests, and needs. this goes not just for us as writers, but also (and perhaps specifically) for our audiences. what may be obvious to one is not necessarily obvious to another. • on a societal level: why is this type of communication important? medical communicators help protect the public’s health. when done well, our work contributes to societal advancement and scientific education. • on a personal level: why is it important for you? what are your goals? do you work to educate others, to influence policy, and/or to advocate for change? the underlying theme for all these levels is trust—trust in our own abilities to provide accurate and valid information in a clear, understandable way, trust in us by our audiences and clients, and trust in the science by the general public. as the often-faceless go-betweens of the scientific and medical communities and the general public, our ability to parse and describe is the foundation of the trust between these groups. to facilitate that trust, just like with the questions we must ask ourselves as we develop our projects, our audiences ask themselves their own questions. • the general public asks, “how does this affect me?” • policy makers and/or scientists ask, “does this affect my work?” or “should we fund this?” • the media asks, “is this newsworthy?” as we address these concerns, we should always remember that building trust between different groups and communities is essential. the first piece of advice is to know your audience. how are they, in general, most likely to approach the topic? is there skepticism or open-mindedness? are they perhaps predisposed to be hostile or accepting of the information? the tone, the language, and the anticipated audience engagement are all 3 highly relevant aspects we can use to help guide our writing. we need to tailor our messages as much as possible toward the specific audiences. second, a helpful hint (particularly when addressing the general public) is to “think in threes.” consider the general parts of good storytelling, or even of something as simple and familiar as a knock-knock joke: an event or incident intrigues people, a conflict arises from that event, and then a resolution is achieved. using a familiar and generally accepted pattern goes just that little bit further in helping audiences remember the information that is presented. to expand our audience reach, interacting with the media is sometimes a necessity, and one that involves its own skill set. you should make the assumption that if there is a way for the media to misinterpret the information you are providing, it is likely to happen. reasons for that are that the media world moves very quickly, journalists have a variety of sources at their disposal, and news organizations in general are not good at covering long-term issues. to overcome these hurdles, be sure to provide accurate, clear, and concise information. in short, get to the point as soon as you can. try not to provide extraneous information that could either muddle the topic or be misconstrued in edited sound or video clips. the “thinking in threes” rule of thumb for general audiences is also helpful when speaking with members of the media. your points can be preplanned and even rehearsed (depending on your level of experience or comfort with public speaking). in any case, make sure to point out the big picture of the topic or research. and remember, if you don’t want to hear it, see it, or read it, don’t say it. there really is no such thing as off-the-record. remember that science changes over time; it evolves. scientists accept this environment, but the general public often tends to view science and health news more often with nervousness and mistrust. explain results clearly and conscisely, and then present the possibilities of what comes next in order to build that necessary trust. that in turn makes medical writers more effective liaisons between the scientific world and the general public. katherine feemster is the owner and chief writer at the green fire company, llc. educational sessions http://www.amwajournal.org amwajournal.org 57jam session for earlyto mid-career freelancers author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: kfeemster@greenfirecompany.com jam session for earlyto mid-career freelancers session moderator jennifer minarcik, ms / principal, jennifer minarcik biomedical communications, llc, moorestown, nj by suzanne morris, dvm, mwc about 15 freelancers and freelancers-to-be gathered at the amwa 2022 southeast regional conference in june to share their early freelance career experiences. some of the participants had just decided to take the freelance plunge and were eager for tips on setting up a new business whereas others with more experience were wanting to share lessons learned. session facilitator jennifer minarcik, ms, started the discussion by divulging some of the assumptions she had when she first started her freelancing career. she spoke to the misperception that freelance medical writers are all in competition with each other by pointing out the diversity of medical writing genres represented by the session’s participants. acknowledging that the varied nature of freelance medical writing lends to camaraderie rather than competitiveness among freelance medical writers led to a discussion of networking. although making connections with other freelancers may not translate to immediate work, networking can develop leads, elevate a freelancer’s marketplace presence, and unearth other benefits. one of the more valuable of these benefits may be finding a good mentor. the more experienced session participants extolled the benefits of mentorship in guiding their early freelancing careers. but how does a new freelancer go about finding a mentor? those who had who have benefitted from mentorship described a relationship which naturally developed from a networking connection. another early career misstep minarcik discussed was the compulsion to take on every project, and the consequent erosion of the work-personal life border. minarcik and the other more seasoned freelancers agreed that project selectivity fosters a reasonable work schedule and, potentially, better clients. because part of cultivating a work-life balance entails supporting work hour productivity, the discussion then turned to productivity strategies. for example, creating a schedule with built-in time to respond to distractions like emails supports productivity during work hours. protecting work time also may require establishing boundaries with clients by responding to clients only during set work hours or at set times during the week. the conversation turned to some of the other nuts-andbolts of running a freelance business. as with most freelance medical writing discussions, the topic of contracts arose, albeit briefly. the take-home message for new freelancers was to carefully review contracts, particularly with respect to payment parameters. some of the freelancer participants who were just forming their businesses asked for advice on insurance and accounting. the responses from the more seasoned participants were mixed—few had insurance, and several used accounting services and software. but the consensus was that some form of accounting assistance was very helpful. inevitably, the discussion turned to what may be the most daunting aspect of freelance medical writing or freelancing in general: marketing. the importance of presence online, particularly on platforms like linkedin, was discussed at length by several seasoned freelancers. for introverts averse to overt self-promotion, a less intimidating approach may be simply posting about topics of interest, which creates an online presence and can garner attention. another strategy was to investigate companies associated with relevant forms of medical writing on linkedin and make connections with their employees. whether to solicit potential clients through email was a point of debate, with the more experienced freelancers advising that if done, it should be targeted and could backfire by annoying the targeted client. the discussion of marketing repeatedly circled back to value of networking, which can be done online and in person through, for example, amwa events. and in keeping with its overriding theme, this amwa session ended with participants exchanging their business cards. suzanne morris is the owner of concrete medical writing, llc, in st. petersburg, fl. author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. author contact: suzanne@concretemedicalwriting.com public relations in medical communication speaker katrina r. burton, bs / public relations program director by lisa kuhns, phd according to the public relations society of america, organizations and their publics use public relations as a communication strategy to build relationships that are mutually beneficial. medical communicators help educate the public by sharing relevant health information through their own writing, and those with a marketing and public relations http://www.amwajournal.org v38 n2 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 55 speakers tim day (moderator) principal/owner, innovative strategic communications, llc, milford, pa michael platt, ms, cmpp evp, managing director, virgo health glenn s. tillotson, phd, fidsa, fccp, fisc consultant microbiologist, gst micro llc, north, va by kathleen scogna as we enter the fourth year of the covid-19 pandemic, many of us have begun to look back and reflect on how much our personal and professional lives have changed since “before covid.” like all professions, the scientific publishing world has had to adapt to a new set of expectations and priorities imposed by the global pandemic. in this talk, 3 publishing professionals give their perspectives about how this “new normal” has affected all aspects of scientific publishing, whether these changes are here to stay, and the likely impact they may have on the medical writer. “the great resignation” michael platt, ms, cmpp, executive vice president and managing director of virgo health, a medical education company located in new york city, focused on what has been called “the great resignation,” when millions of workers— many of them in the healthcare and science fields—took stock of their work lives, disliked what they saw, and left their jobs for other industries. some dropped out of the workforce altogether. the aftermath of the great resignation may be positive for the medical writer who’s prepared to jump through a few hoops. the demand for talent is high: 71% of life science companies plan to increase their workforce in 2022. but employers now are taking steps to check whether a candidate is committed to staying and that they can handle curveballs. mr platt lists 5 interview questions that candidates should be prepared to answer when applying to an agency: 1. “what is your ideal work environment?” 2. “why did you leave your last job?” 3. “why do you want to work for this company?” 4. “describe a stressful situation and how you handled it.” 5. “what are your immediate career goals?” candidates should also expect to be asked to take tests, give presentations, or write sample articles during the interview process to demonstrate their writing abilities. the savvy candidate should not only ensure that their skills are up to snuff but also develop 4 key competencies mr platt believes are crucial to succeeding in the current environment: 1. “being human” 2. transparency 3. accountability 4. urgency although the good news is that medical writers are beginning to sense their worth and are asking for (and often getting) higher salaries and freelance rates, it’s not enough to be a good writer. to flourish in this landscape, mr platt contends that the best candidates are lifelong learners committed to communicating data and knowledge to make a difference in the world and in patients’ lives. the rise of the preprint in the publishing space, ethics took a huge hit during the pandemic, with inevitable consequences. glenn s. tillotson, phd, a healthcare scientist in global infectious disease drug development and now editor-inchief of expert review of anti-infective therapy, described the state of scientific publication in 2020 as a “tsunami” (figure 1). as clinical trials into covid therapeutics took off, publishers scrambled to keep up with the rising tide of publications. one solution to quickly disseminate this information was by using preprints, or posting papers on a journal’s server or website “as is,” without editing, peer review, or the usual checks performed by the publisher before publication. although preprints aren’t new, the number of preprinted articles increased dramatically during the pandemic. and, not surprisingly, the number of retractions increased as well. dr tillotson also described a rise in plagiarized content in the manuscripts his journal receives, although it has been difficult to know whether these are deliberate instances of copying or the result of overly enthusiastic cutting and pasting. whatever the cause, it’s not difficult to conclude that the pressure to publish cutting-edge covid research, lack of staff to oversee the publishing process, session report the new normal in the medical publications sector conference http://www.amwajournal.org amwajournal.org 56the new normal in the medical publications sector and lowering of publication standards have created an ethical dilemma that the scientific publishing world must address in the coming years. mental health in the workplace tim day, owner of innovative strategic communications with an extensive background in pharma, spoke about the pandemic’s unforeseen impact on workers’ mental health. recent surveys1,2 found that over three-quarters of us workers experienced at least one symptom of a mental health condition in 2021, more than 80% identified their place of work as a contributor to at least one mental health challenge, and most workers are looking for workplaces that support mental health in the future. given these findings, moving forward in the postpandemic era requires businesses to normalize discussions about mental health and commit to fostering the well-being of their workforce. a report published by the us surgeon general report cited 5 essentials for achieving these goals (figure 2). as we approach yet another transition in the pandemic—the return of at-home workers to brick-and-mortar offices—employees and freelancers need to take stock of lessons learned over the past 3 years and apply them to the new normal in scientific publishing. mr day encourages staff writers to consider whether their positions are suitable for at-home work and to discuss this possibility with employers. and all employees, whether staff or freelance, should strive to develop strategies to balance work, family, and mental health. if the pandemic has taught us anything, it’s that mental health in the workplace is no longer optional but essential for both the well-being of individual employees and the industry as a whole. kathleen scogna is the senior director of education at the society for maternal-fetal medicine in washington, dc. author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. author contact: kscogna@gmail.com references 1. 2021 mental health at work report. mind share partners. accessed december 11, 2022. https://www.mindsharepartners.org/ mentalhealthatworkreport-2021 2. workers appreciate and seek mental health support in the workplace. american psychological association. accessed december 11, 2022. https://www.apa.org/pubs/reports/workwell-being/2022-mental-health-support 3. the us surgeon general’s framework for workplace mental health and well-being. us department of health and human services. published 2022. accessed december 11, 2022. https://www.hhs. gov/surgeongeneral/priorities/workplace-well-being/index.html figure 1. number of scientific publications in 2020, 2021, and 2022. figure 2. five essentials for workplace mental health and well-being. from the us department of health and human services.3 0 20,000 40,000 60,000 80,000 100,000 120,000 140,000 2020 2021 sep-22 93,649 139,207 101,609 publications since publications since five essentials for workplace mental health & well-being componentscentered on the worker voice and equity, these five essentials support workplaces as engines of well-being. each essential is grounded in two human needs, shared across industries and roles. creating a plan with all workers to enact these components can help reimagine workplaces as engines of well-being. *diversity, equity, inclusion & accessibility protection from harm • prioritize workplace physical and psychological safety • enable adequate rest • normalize and support mental health • operationalize deia* norms, policies, and programs work-life harmony • provide more autonomy over how work is done • make schedules as flexible and predictable as possible • increase access to paid leave • respect boundaries between work and non-work time mattering at work • provide a living wage • engage workers in workplace decisions • build a culture of gratitude and recognition • connect individual work with organizational mission connection & community • create cultures of inclusion and belonging • cultivate trusted relationships • foster collaboration and teamwork opportunity for growth • offer quality training, education, and mentoring • foster clear, equitable pathways for career advancement • ensure relevant, reciprocal feedback worker voice and equity centered on work-life harmony autonomy flexibility connection & community social support belonging protection from harm safety security mattering at work dignity meaning opportunity for growth learning accomplishment http://www.amwajournal.org https://www.mindsharepartners.org/mentalhealthatworkreport-2021 https://www.mindsharepartners.org/mentalhealthatworkreport-2021 https://www.apa.org/pubs/reports/work-well-being/2022-mental-health-support https://www.apa.org/pubs/reports/work-well-being/2022-mental-health-support https://www.hhs.gov/surgeongeneral/priorities/workplace-well-being/index.html https://www.hhs.gov/surgeongeneral/priorities/workplace-well-being/index.html v38 n3 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 28 q1: what are the potential benefits and limitations of using chatgpt in medical writing, and how can these be mitigated? many writers in the continuing medical education (cme) field who have been exploring chatgpt as a tool to generate ideas see at least 3 possible use cases. first, if you are unfamiliar with a disease state or therapeutic area at the beginning of a project, chatgpt can be a valuable research assistant that rapidly finds information to help organize your thinking, generate feedback on your work, and summarize research literature. you can ask chatgpt to provide a targeted overview and an “at-a-glance” perspective on the basics. but that’s what you’ll get. you’ll still need to do a much deeper dive into the peer-reviewed and evidence-based clinical practice literature. second, some writers are using chatgpt for efficiency gains. they create detailed prompts for chatgpt to generate outlines for needs assessments and ideas for practice gaps. writers i’ve spoken to who are experimenting in this way then validate and build out practice gaps using the literature. third, chatgpt is being explored to support adaptive learning by generating patient cases, providing responses to learner questions about those cases, and prescribing relevant resources for additional feedback and remediation. in all these potential use cases, the key to any degree of success is prompt engineering that shares sufficient detail and clear parameters with chatgpt at the outset. the downside is that there is absolutely no guarantee that the information chatgpt returns will be in any way accurate, and it certainly won’t be supported by evidence. several journalists and scientists have now drawn attention to inaccuracies and false citations that chatgpt generates because no one is fact-checking. if we cannot attribute claims to published sources, then we cannot use the content. so, if you are exploring chatgpt, you’ll need to find and corroborate the sources and rigorously fact-check the integrity of information it returns. in my mind, the time to check facts will swallow any efficiency savings. using chatgpt and other artificial intelligence (ai) tools to generate ideas and content could also nudge writers into sloppy habits. it’ll be easier to lose track of your source material if that material is not anchored to specific references. another limitation is that chatgpt does not have the capacity to notice and process context and cannot provide nuance or perspective. these are human characteristics. as a result, medical writers will and must remain the primary drivers of content integrity in cme and continuing education for health professionals. —alex howson chatgpt is a program focused on language-related tasks that “understands” natural language and can answer questions and requests. gpt stands for “generative pretrained transformer.” chatgpt was developed by openai and released to the public in november 2022. the public interface was trained on information taken from the internet up through september 2021; thus, the information is slightly out of date, unless you input more recent information during a conversation. the public interface is free and requires no setup. once you provide your email address and a password, you can type in a question or a request. the best answers come from questions that are as specific as possible. benefits of chatgpt chatgpt has several potential benefits for medical writing. in a webinar i attended, attendees from a medical communication (med comm) company noted that chatgpt can be used as an initial research tool, for example, to ask for background or an overview of a therapeutic area. here are some examples: • “provide peer-reviewed references for us colonoscopy guidelines within the last 10 years” • “explain current treatments for acute myeloid leukemia to an oncologist in fewer than 500 words” chatgpt can help overcome writer’s block by providing a starting point, summarizing a group of paragraphs you upload, or suggesting ideas for slide titles. here are some examples: freelance focus melissa l. bogen alex howsonbrian bass cathryn d. evans ruwaida vakil http://www.amwajournal.org https://chat.openai.com/auth/login https://networkpharma.tv/2023/05/03/ai-today-and-tomorrow-real-world-applications-for-medcomms/ amwajournal.org 29freelance focus • “summarize the introduction and conclusions of the following publication as bullet points <insert content>” • “rephrase the following sentence to be more concise <insert content>” chatgpt can help repurpose material for different audiences. it can rewrite scientific material in lay language; adapt training modules for physicians to ultrasound technicians; or write a key opinion leader’s bio for a medical meeting from a resume that you upload. • “write a 200-word biography of this professor of radiology to be shared with peers <insert complete resume>” • “rewrite this text to be language-appropriate for children ages 9-12 <insert abstract>” • “turn this journal abstract into a slide presentation <insert abstract>” chatgpt helps spark the creative process by providing an initial summary of information but not final draft material. humans are needed to apply thought and judgment to the proposed answers. it’s not doing all the work for you, but it can make some tasks easier. limitations of chatgpt you need to check all facts and the quality and accuracy of all references. by openai’s own admission, chatgpt may produce inaccurate information about people, places, or facts. in other words, it can say things that are not true. in a recent email exchange on amwa engage, participants noted that chatgpt created fake references. because of nondisclosure agreements in place, medical writers should upload only public data to this third-party application. chatgpt uses personal information you provide to provide, administer, maintain, improve, and/or analyze its services. although chatgpt provides information in its privacy policy on how you can opt out of their use of your content to train the models, uploading patient data and other private information would be a mistake. —melissa l. bogen in my opinion, the benefits of chatgpt are in the eyes of the beholder. i don’t personally see any benefits from the medical writer’s perspective because the role of chatgpt is to do the job of the medical writer. if we’re not doing the research, reading and synthesizing what we find, and distilling what we learn into clear, concise, and accurate language that is accessible to our target audiences, then what are we doing? in that vein, chatgpt has the potential to turn medical writers into reviewers, which may not be many medical writers’ cup of tea. chatgpt has vastly deeper, broader, and faster access to information than medical writers will ever have. but currently, chatgpt does not have the ability to filter information from misinformation, and it cannot take responsibility for its content as medical writers and authors must. if a reviewer wishes to question a sentence or a paragraph written by chatgpt, who is there to ask? chatgpt currently doesn’t have the capacity to explain or justify itself. it simply is. it is the medical writing equivalent of “because i said so.” so, who do i think can currently benefit from chatgpt in the medical writing space? to a large degree, content mills, because they already don’t care about accuracy or accountability. predatory publishers are another unscrupulous group that i think can immediately benefit from the speed and power of chatgpt. but i do think there’s a legitimate side to chatgpt’s potential as a medical writing tool by limiting the information it can source and what it can do with that information. for example, limiting chatgpt to only the information contained within a specific set of resources and giving it a prescribed template in which to apply that information is a task for which i think chatgpt is potentially well suited. but the content chatgpt produces must still be reviewed, scrutinized, and when necessary, questioned. this may, in turn, create more opportunities for medical writers and medical editors who love to fact-check. —brian bass benefits of chatgpt include helping to amalgamate information related to some of various research questions. an it friend put >10 questions to chatgpt on my behalf (because i have not yet started using it on my own computer). the questions related to medical/science issues, political topics, philosophical/religious topics, and simple pragmatic queries. many factual errors as well as errors of “narrowness” resulted! as well, it was clear that the ai may provide biased answers. serious questions, in my opinion, should not be put to chatgpt (at least not at this time). other alarming impediments include not providing published, bona fide (respectable) reference citations for chatgpt’s opinions; one must specifically ask for references to be included; moreover, when we asked chatgpt to include reference citations, some of them were incorrect ! another danger is the risk/ temptation for a person to plagiarize chatgpt (which has already plagiarized someone else, of course, with no attribution). i suspect much of this is already taking place without attribution. i did, however, receive helpful information in response to a certain question: i had googled and done other searches about growing a potted rosemary plant indoors. after several unsuccessful results, we finally got a very http://www.amwajournal.org https://openai.com/policies/privacy-policy https://openai.com/policies/privacy-policy https://help.openai.com/en/articles/5722486-how-your-data-is-used-to-improve-model-performance amwajournal.org 30freelance focus helpful reply from chatgpt, which not only amalgamated replies i had received elsewhere but elaborated more specifically on my geographic location, the dry climate, and high altitude. (in the end, after killing 6 rosemary plants, i learned that, in fact, the conditions inside my home are not amenable to growing rosemary. chatgpt was the preferred source. so, i stopped wasting money on these plants.) at this time, i do not think we should be using this ai program for serious professional medical writing. nor do i think we can do much to mitigate the problems other than to commit ourselves to doing our homework, maintaining our integrity and ethics, and not succumbing to the temptation of laziness, ie, allowing chatgpt to do work for us that our human critical thinking/intuitive minds should be doing. —cathryn d. evans ai technologies such as chatgpt have unleashed a pandora’s box. recently, congress had the opportunity to hear from sam altman, the founder of openai, the organization behind chatgpt. altman expressed concern about the potential for ai to spread misinformation, highlighting the genuine threat it poses. in his address to congress, altman emphasized the urgent need for regulation to mitigate these risks. although regulations are currently lacking, hopefully they will be implemented soon. as medical writers, we must grasp both the advantages and limitations of ai technologies. despite the absence of regulation, ai is here to stay. we can harness the power of chatgpt as an advanced search engine, but importantly, exercise caution and fact-check all the generated content. chatgpt exhibits inaccuracies in developing references for its text; thereby, a critical evaluation of its generated references is necessary. some have drawn comparisons between chatgpt and wikipedia, with arguments against chatgpt reminiscent of those once made against the reliability of wikipedia. nonetheless, wikipedia has persevered and flourished despite the initial skepticism. similarly, chatgpt will continue to propagate and evolve, irrespective of whether we choose to employ it. to illustrate the power of chatgpt, i generated my response without the help of chatgpt, and then i put my response in chatgpt and asked it to expand on my answer. chatgpt was able to summarize and expand on what i wrote while maintaining my ideas, focus, and flow. i did edit what chatgpt generated, and what you read in the previous paragraphs is the result. although ai may not yet replace medical writers, medical writers who utilize ai effectively could outperform their peers. ai should be viewed as a tool that complements and enhances our capabilities rather than directly threatening our profession. adapting to this technology will enable medical writers to capitalize on the opportunities that ai provides while ensuring our continued relevance and success in an increasingly ai-driven world. —ruwaida vakil * * * q2: what ethical considerations need to be taken into account when using chatgpt for medical writing, particularly in relation to patient privacy and data protection? bias, copyright, and informed consent around data use are serious ethical concerns with chatgpt. ai like chatgpt is trained on speech, text, and images it scrapes from realworld content that is already in the public domain. much of this content is structured by an existing inbuilt text and image bias that obscures heterogeneity in terms of gender, race/ethnicity, and other characteristics. researchers like timnit gebru, founder and executive director of the distributed artificial intelligence research institute, note that the data that large language models like chatgpt encode are more likely to represent the perspectives of people who already occupy considerable internet real estate compared with women and people of color, who spend less time and have less access to determining online content. so, the idea starters and writing prompts that initially seem appealing as efficiency levers might already be culturally and racially biased, or at least lack cultural sensitivity and specificity. unless medical writers are intentionally using chatgpt and other ai tools through an equity and inequality framework, we will unwittingly reproduce bias. copyright implications for both image and text are also pressing. on the one hand, who owns ai-generated material? the us copyright office is actively exploring this question via a new initiative, but at the moment, if writers are using generative ai tools to create content, they do not own that content. also, although many medical writers create content as employees or are bound by work-for-hire contracts, if you use ai-generated content to write blogs or books in your own name, anyone can reproduce it without your permission. on the other hand, although copyright is meant to protect material that is the product of human creativity, various ongoing lawsuits point to the ways in which copyrighted materials are already being used to train ai tools like chatgpt without attribution, compensation, or credit to their creators. another problem concerns the information we, as users, feed into chatgpt. for instance, some clinicians have posted on social media how they are “testing” chatgpt’s diagnostic capacities by feeding it anonymized history of present illness (hpi) data. even if hpi data are anonymized, the data enter the public domain and are available to others http://www.amwajournal.org amwajournal.org 31freelance focus without patients giving consent for their own data to be shared publicly. we cannot be luddites and push against the tide of technology. ai is going to change communication processes and practices whether we like it or not. but the direction that ai takes is not inevitable. we can and must influence how tools like chatgpt are applied in practice. —alex howson i think there are several important ethical considerations to be taken into account with the use of chatgpt for medical writing. first and foremost, chatgpt lacks a moral compass. information that’s accessible is information that’s usable, whether it is accurate or inaccurate, biased or unbiased, public or confidential. this is of particular concern with respect to protecting patient privacy and proprietary data in medical writing. i’m not a programmer, but it seems to me this challenge is potentially surmountable because the types of information that can reveal a patient’s identity are themselves identifiable and should therefore be able to be targeted as “off limits” to chatgpt. it then becomes the job of reviewers to ensure that sensitive information is edited out of documents before they’re published. another big ethical consideration with the use of chatgpt in medical writing is accuracy. chatgpt has every electronically accessible resource at its disposal from which to develop content, and as we all well know, not all that information is accurate. furthermore, there’s growing evidence that chatgpt can, and does, lie. this places an additional burden on reviewers to check and double-check chatgpt’s work. but this brings me to my third big ethical concern regarding chatgpt: accountability. no one—not even its inventors and keepers—knows how chatgpt does what it does. without the ability to question chatgpt’s writing or hold it accountable for what it’s written, medical publishing ethicists like the committee on publication ethics (cope), organizations including the world association of medical editors (wame), and publishers such as the jama network have all said that ai tools such as chatgpt cannot be listed as the author of scholarly papers. developers have put chatgpt out there with all its faults and shortcomings, anticipating that real-world experience will teach and improve it. i’m sure it will. however, in a field as reliant upon sound ethical practices as medical communication, i think we currently have too much to lose by putting too much faith in chatgpt. —brian bass the 3,000 springer-nature journals, elsevier’s 2,800 journals, taylor & francis, jama network, wame (and british medical journal), and the international committee of medical journal editors (icmje) ban the listing of chatgpt as an author. the lancet digital health (owned by elsevier) published a commentary entitled, “generating scholarly content with chatgpt: ethical challenges for medical publishing,” complete with a response from chatgpt in its supplementary material on the effect of ai on publishing ethics in medical publishing. these updated journal guidelines require that authors report the use of chatgpt during manuscript preparation in the acknowledgement section. the burgeoning popularity of chatgpt will undoubtedly lead to the development of more policies around its use and increase the importance of using human fact checkers. —melissa l. bogen * * * q3: how can chatgpt be used to assist medical writers in creating patient education materials, and what challenges need to be addressed in this context? despite the caveats i put forth earlier in question 1, i do feel there may be some interesting uses of chatgpt in this context. (assuming, of course, that one maintains personal and professional integrity and does one’s own work prior to querying and relying on chatgpt.) first, let me point out that i include in the category of “patient education” the following types of medical writing tasks with which i have personal experience—all of these require the simple clear language one should use for patients/consumers: • pharma/biotech regulatory affairs: informed consent forms; lay summaries (plain language summaries); standard operating procedures; and other “instructional documents” for in-house or outside use • pharma/biotech med comm, marketing communication, sales, and public relations (corporate communication): patient education materials of all sorts; slide presentations or other company website information targeted to the general public (and perhaps to investors as well); sales training materials; collateral advertising materials directed toward patients • health maintenance organizations or managed care organizations: letters to members and provider offices explaining services clearly; policies & procedures (p&ps) • hospitals, medical centers, doctors’ offices: patient education materials; website copy intended for the layperson http://www.amwajournal.org https://publicationethics.org/cope-position-statements/ai-author https://wame.org/page3.php?id=106 https://wame.org/page3.php?id=106 https://jamanetwork.com/journals/jama/fullarticle/2801170 https://pubmed.ncbi.nlm.nih.gov/36694020/ https://www.elsevier.com/about/policies/publishing-ethics/the-use-of-ai-and-ai-assisted-writing-technologies-in-scientific-writing https://authorservices.taylorandfrancis.com/editorial-policies/defining-authorship-research-paper/ https://jamanetwork.com/journals/jama/fullarticle/2801170 https://wame.org/page3.php?id=106 https://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html https://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html https://www.thelancet.com/journals/landig/article/piis2589-7500(23)00019-5/fulltext https://www.thelancet.com/journals/landig/article/piis2589-7500(23)00019-5/fulltext https://www.thelancet.com/journals/landig/article/piis2589-7500(23)00019-5/fulltext amwajournal.org 32freelance focus • nonprofit health care organizations: parts of grant applications and their interim reports; patient education fliers for their clients; p&ps; other medical information documents they may create for their clients • medical journalism: articles for publication in lay magazines and trade journals reporting new information about diseases and medicines; website copy targeted to the layperson certainly, there are other areas, but all the mentioned examples require a voice similar to that required for “patient education” materials. one might use chatgpt to assist in formatting and organizing a plain language summary—first by asking for samples of various companies’ formats for such summaries (some of which are offered on the food and drug administration website and elsewhere, but chatgpt would offer several samples). this could help an inexperienced medical writer to understand how such summaries are best designed. one might also submit to chatgpt the summary one has already written and request improvement. one might submit a less simple example of any of the mentioned documents one has already written and ask chatgpt to revise it—just to see if the ai program does indeed offer improvement in structure or language (always, of course, being careful not to allow plagiarism to creep in). the main challenge, it seems to me, relates to discrimination in fact-checking and ensuring that plagiarism has not occurred. likely there are other caveats, but i have not used the ai program(s) extensively enough to identify other difficulties or challenges. —cathryn d. evans additional information: a developer interface in addition to chatgpt, openai also has a developer interface available for us $20/month. in a webinar i attended, attendees from a med comm company noted this private interface could be used by pharmaceutical or medical communication companies on behalf of clients. its advantages are that data could be kept confidential, larger data sets can be uploaded, and the user has more control over the responses. here are some uses and examples. the developer interface could generate internal reports from multiple data sources and summarize advisory boards (eg, executive summaries). however, it will be a while before it can be trained to ignore the nonsensical chatter in an ad board transcript. the developer interface could be trained to act as a medical information chatbot (not for public release). the user could input prescribing information, a clinical study report, and published studies. these data could be used to draft medical letters or answers/replies. the interface could rewrite existing content from, say, a pharmacist geared toward another audience. the private interface could also provide consistency to omnichannel materials. it could ensure that the information is relevant to different audiences and could repurpose material into new formats (eg, from video to slide deck) much faster than a person could. but again, with the noted limitations, humans are needed for their thought, judgment, and discernment for accuracy and relevance. —melissa l. bogen general principles of word usage www.amwa.org/online_learning choose the right word for accuracy and clarity. http://www.amwajournal.org https://networkpharma.tv/2023/05/03/ai-today-and-tomorrow-real-world-applications-for-medcomms/ american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. v37 n1 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 11 the john p. mcgovern award is named in honor of john p. mcgovern and is presented to a member or nonmember of amwa to recognize a preeminent contribution to any of the various modes of medical communication. the mcgovern award is presented during amwa’s medical writing & communication conference. hello, amwa attendees. i’m stacy christiansen, and i am incredibly humbled to be talking to you as the 2021 john p. mcgovern award winner. looking through the list of previous winners leaves me a little starstruck; i am in incredibly good company. i have been very fortunate to spend my medical communication career at one organization, the american medical association (ama). i was hired in the last century (but very, very late in the last century) as a copy editor for the specialty journals published by the ama. their names at the time were archives of dermatology, archives of internal medicine, and a handful of others. they have been successfully rebranded as jama dermatology, jama internal medicine, etc. after a few incredibly instructive years as a copy editor, i had the opportunity to move over to the flagship journal, jama. one of the main differences with jama was applying all of the skills and knowledge i had gained, but faster. i was up for the challenge and the rest is history. i moved from copy editing manager to managing editor of jama. i’ve also been a member of the committee that produces the ama manual of style since 2002. i worked on the 10th edition, and then became the co-chair for the eleventh, just published last year. before i dive in, i just want to take a brief minute to give thanks where it’s due—to acknowledge the people who have mentored me, educated me, and supported me along the way. the person who fills all of these roles is jama network executive managing editor annette flanagin, who, by the way, won this award in 2009. annette is a manager, educator, problem-solver, and cheerleader all in one, and she has set the bar high at jama, but is always willing to give me a boost to reach it. another mcgovern award winner has also been a huge influence on me, and that’s cheryl iverson, the previous chair of the ama manual of style committee. she won the award back in 2004. cheryl is one of the most upbeat, can-do people i have ever met, and her support and encouragement helped me believe i could wrangle this stylebook, no problem. there are a host of others who have been instrumental, including all sorts of folks at jama, from editors in chief to all of the amazing manuscript editors, systems administrators, editorial assistants, and production staff. also, amwa and council of science editors (cse) colleagues, a number of people at oxford university press, and even authors, readers, and tweeters who share their experience and feedback. i owe a debt of gratitude to a host of individuals for helping me along this path. so, in thinking about this talk, i settled on style and substance as the title, because that’s one phrase i feel sums up a lot of our work in medical communication. and then, i struggled with a subtitle. my first idea was “but what do you do?” i’m sure i’m not alone in this scenario. you’re at a gathering with people you’re meeting for the first time, and they inevitably ask what you do for a living. and you reply, “medical writer,” or worse, “medical editor.” medical writer at least is sort of clear: you write about medical stuff. but medical editor? one well-meaning older man asked if that meant i was a secretary—his word. other times i’ve been met with a blank stare and the question, “yeah, but what do you do?” so, i thought about that. what do we do? my personal philosophy can be summed up as acc. that’s an acronym i coined for accuracy, clarity, and consistency. as an editor, those are the paramount goals of anything i work on, from stacy l. christiansen, ma / managing editor, jama, and chair, ama manual of style committee, chicago, il 2021 john p. mcgovern award address style and substance conference http://www.amwajournal.org amwajournal.org 12style and substance a brief news item to a large groundbreaking clinical trial. a good editor should be behind the scenes helping an author ensure that the science is communicated accurately, clearly, and consistently. there are varying perspectives about what editors actually do, from people who aren’t sure, to those who are as invested in the product as editors are—namely writers— and, of course, the “track changes” reality. there have been some attempts to place value on editorial work, such as a comparison of unedited papers with final publication. in this study from 2015,1 readers were asked to read 4 articles in their unedited and edited versions. while these articles were principally news stories and not trial reports, i think the findings are relatable. readers preferred the edited versions, and felt the quality was worth the cost. two papers published in 2007 in learned publishing also investigated the changes between author manuscripts and final published versions.2,3 in the first study, a review of 189 articles published in science, technology, engineering, and mathematics journals or humanities publications compared the author’s version with the final article. a substantial amount of edits worked to correct citation errors, a third of the edits fixed grammatical or stylistic problems, and nearly 14% of the edits queried missing data. the authors concluded that editing contributes substantially to the accuracy of the paper and is therefore an important function for the integrity of the article of record.2 the second paper in learned publishing was by goodman and colleagues, and it compared self-archived manuscripts with the published versions. this study looked at 24 papers in biochemistry or social sciences, and the results were similar to the first study. in general, the editing helped improve the readability of the paper, although no errors were serious enough to invalidate significant data, conclusions, or the overall validity of the findings, and none of them would warrant a correction or a retraction.3 a slightly older study was presented at the peer review congress in 2001.4 this was a systematic review of the literature on technical editing, which has been posited to improve accuracy and clarity—2 of my acc words. the authors found 11 studies of technical editing that concluded that editing improves readability, may improve quality, and increases the accuracy of references and quotations. it also elevates the accuracy of abstracts.4 there have been some other efforts to validate the contributions of communication professionals, but i have yet to see any study that says, “nah, don’t bother.” as i mentioned earlier, i was hired at the turn of the century, and we still did a lot of things on paper. we were just learning how to edit in microsoft word, and some of us learned to write custom scripts. my first script removed the 0 before the decimal point in p values. i am still super proud of that very basic script that no one uses. among editorial staff, there was some general fear as technology evolved that editors might be replaced. spellcheck and grammar checking in word were the first software-based features that took on some of an editor’s responsibilities, followed by more sophisticated programs such as software that autocorrects errors, or that fixes terminology based on preselected rules (for example, changing british spelling to us spelling). technology can be incredibly helpful to improve quality by spotting errors, but we’ve all had a good laugh over autocorrect or spell czech. i get really tired of spellcheck’s shirt; that process can go to he’ll. i realize that correct spelling is impotent, but sometimes the corrected words aren’t write. and sometimes it’s not individual words but sentence construction that editors need to fix. for example: the patient has chest pain when lying on her right side for over a year. the patient lives at home with his mother, father, and pet turtle, who is presently enrolled in daycare. editors work to preserve the credibility of a paper and of a journal or other publication as a whole. while i know we’ve all had a good chuckle about menu gaffes and not worried too much about how the food would be, the same is not true of more serious communication. as the patient, if you were provided a document intended to address your concerns about a new medication or a diagnosis, what would your confidence be if it were riddled with errors? we might assume anyone or any company that did not take the time to do something as straightforward as proofreading might not have done the necessary quality checks on the product or information itself. the ninth international congress on peer review and scientific publication is set to meet in september 2022. get your research done! abstracts can be submitted now. http://www.amwajournal.org amwajournal.org 13style and substance and although technology might be able to assist with some functions of a writer or editor’s job, it simply will never replace the judgment a human brings to the work. there is nothing misspelled or grammatically wrong with the sentence, “this medication is for diabetics.” but a well-trained writer or editor will tell you that it’s best to use patient-first language to avoid labeling people with a disease or a condition. microsoft word would pass over that sentence with nary a red squiggly line, but the editor would recast it as “this medication is for patients with diabetes.” the same is true for language addressing people’s sex or gender, age, socioeconomic status, race and ethnicity, or disabilities. writers and editors are in tune with inclusive language in a way that even the most sophisticated software cannot replicate, so clearly human editors are important. and as advanced as technology becomes, medical writers and editors will always be needed if the desired result is clear, accurate, and valid content. editors’ work with references is particularly important— ensuring that references are cited, are associated with the right content in the text, and are complete enough that they can link to the original source, allowing readers to access the primary information. knowing when citations are needed, which citations are appropriate vis-à-vis the reference list, and ensuring citation accuracy really rely on welltrained medical writers and editors. i realize some of you are saying, “stacy, you’re preaching to the choir.” and i know that, but it doesn’t hurt to hear evidence to validate our work. consider this your affirmation. your work matters tremendously in helping communicate science clearly and accurately, with the ultimate goal of advancing science and helping patients. you may remember that i mentioned earlier that i was toying with several subtitles for this talk. my second idea was along the lines of “who cares about style?” or “why is it important to use a stylebook?” although we all carry knowledge in our heads, it’s much more efficient and consistent to share it. with the pace of information sharing continually accelerating, it’s inefficient to have to ask around if something is hyphenated. and of course, depending on who you ask or where you look, you might get different answers. having one place to look up guidance will help establish consistent decision-making. i would never ask anyone to read the ama manual of style cover to cover—or any stylebook for that matter— unless you can’t fall asleep. a stylebook is a reference tool, like the dictionary. now, there are definitely sections of a style manual that lend themselves to narrative, and perhaps certain chapters should be must-reads, like those that provide the history of certain policies to give you some context. but essentially, a stylebook is a resource for consultation and guidance. so why should you use a stylebook? because they provide guidance on how to handle small details, substantive issues, and even major problems. for example, you may not remember the rule for using en dashes with compound terms. where does the hyphen go? when do you really need to use the en dash? give me some examples! a style manual is happy to oblige. same thing with comma use. most style guides will share a preference for using the serial comma or not, and it’s important to use (or not use) it consistently. following one main guide or adopting a house style on this point will ensure that all content is in agreement. another guidance point a manual will assist with is what is capitalized in a title, especially if you don’t encounter terms such as in situ or mendelian very often. stylebooks also provide guidance on substantive issues such as data display, for example, the basic formatting of what should be included in a survival curve. the example here provides the general expectations for formatting, like using a nonbreaking scale starting at 0, or, alternatively, at 100. the guide also explains what elements need to be included to interpret the figure, such as the number of patients in follow-up and plotting the progression of time on the x-axis. other substantive guidance a manual will offer might involve language use, in this case guidance on inclusive language. stylebook authors will have done their a collection of commonly used manuals. http://www.amwajournal.org amwajournal.org 14style and substance homework on wording to be used in certain disciplines or in certain situations. in the examples here, there are specific recommendations for how to report on race and ethnicity, as well as disabilities and diseases. note the theme here, which is asking authors and editors to use person first language. finally, a style guide should also provide guidance on major issues, for example in medical articles what to do when an identifiable image of a patient is included with a document for publication. you can see here the manual provides a list of options for how to legally and ethically handle this situation. another major issue that might arise in a writer or editor’s work is dealing with authorship issues. a style manual will likely offer guidance on how to navigate authorship, or at least suggest resources for assistance. this can be very helpful for writers or editors because it provides an authoritative guidance to cite. i can’t tell you how many times i’ve copied and pasted from the ama manual online to help explain what our policy is, or why it is. stylebooks usually also offer guidance on how to organize information, which helps readers digest the information. for example, readers expect an abstract in a clinical trial report, and some even expect that they can skip reading the whole thing, just reading the last paragraph (the conclusions). when the document is organized, ideas flow logically, tables and figures present data efficiently and in a logical order, and readers can skim the paper but still find what they’re looking for, and come away with at least a basic understanding of the study. you don’t have to use the ama manual—although it would be great if you did! the important thing is to have a resource available that will provide guidance in your work, whether it’s a question on comma use, or help with serious issues like conflicts of interest or handling retractions. these are the tools medical writers and editors need to practice their craft: reference tools; software programs for word processing, data display, and reference management; and most importantly, your brains, skills, and experience. the end result is a well-equipped communicator whose work helps the science shine. remember, acc (accuracy, clarity, and consistency) never go out of style. thank you, everyone, for your time and attention, and thank you, colleagues, for the mcgovern award. acknowledgment i thank jodie rothschild, principal medical writer at rothschild medical communications, for her help in bringing the transcript to the page. author declaration and disclosures: the author notes that she is employed by the american medical association, which publishes the ama manual of style. no other disclosures were reported. http://www.amwajournal.org amwajournal.org 15style and substance author contact: stacy.christiansen@jamanetwork.org references 1. vultee f. audience perceptions of editing quality. digit journal. 2015;3(6):832-849. https://doi.org/10.1080/21670811.2014.995938 2. wates e, campbell r. author’s version vs. publisher’s version: an analysis of the copy-editing function. learn publ. 2007; 20(2):121-129. https://doi.org/10.1087/174148507x185090 3. goodman d, dowson s, yaremchuk j. open access and accuracy: author-archived manuscripts vs. published articles. learn publ. 2007;20(3):203-215. https://doi.org/10.1087/ 095315107x204012 4. wager e, middleton p. effects of technical editing in biomedical journals: a systematic review. jama. 2002;287(21): 2821-2824. https://doi.org/10.1001/jama.287.21.2821 screens from the virtual conference #amwa2021 the 2021 alvarez award address by recipient harriet a. washington will be published in a future issue of amwa journal. http://www.amwajournal.org https://doi.org/10.1080/21670811.2014.995938 https://doi.org/10.1087/174148507x185090 https://doi.org/10.1087/095315107x204012 https://doi.org/10.1087/095315107x204012 https://doi.org/10.1001/jama.287.21.2821 american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. v37 n3 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 50 the 2022 medical writing & communication conference is almost here! this year’s submissions continued the tradition of excellence, and the conference committee had a challenging job choosing sessions that would support the growth and development of amwa members both professionally and personally across all aspects of medical writing and communication. the conference theme of elevating health and wellbeing through medical communication will be on display throughout the educational sessions, roundtables, and poster presentations. programming will cover the spectrum of medical writing and communication, from regulatory writing to continuing education to scientific publications, as well as core skills and development training for every career stage. the breadth of offerings is too vast to cover here (see the registration brochure for more details), but here are a few highlights of what is to come. inclusive language, cultural competency, and effective communication to the public will be on display through a variety of sessions. leila emery and joyce hicks from rti health solutions will present on best practices in inclusive language for writers and editors. strategies to develop low literacy patient tools will be discussed by kristie hold and kate perry from atlantis health. the importance of storytelling in health communication will be highlighted in several sessions, including using storytelling to capture exceptional care and build audience trust by ben riggs from kettering health. regulatory writers will have a plethora of sessions to attend, with topics ranging from document writing and time tracking to team leadership and managing complex projects. new and familiar tools will be highlighted with tips and tricks for increasing productivity and managing timelines, from perfectit to power bi. learn about a journalistic approach to writing better abstracts from susan aiello of wordsworld consulting or find answers to all your copyright questions in a session with jill shuman of science communication network. hear how covid-19 has altered the publication landscape in the new normal in the medical publications sector or get advice on how to create the most effective posters from michelle e. sofa of nemours/alfred i. dupont hospital for children. freelancers can “jam” with each other in the popular sessions led by medical communication consultant cyndy kryder to share tips, best practices, and stories of clients gone wrong (or right!). sessions on career development at every stage will be available, including discussions of how to transition into medical writing, building confidence to launch a freelance career, and training leaders within a team. along with all the great educational content will be sessions highlighting the importance of personal development and self-care. learn how being a volunteer chapter leader can help build skills and relationships, hear how emotional intelligence can be an effective tool in self-advocacy, and get techniques to take care of stress and tension. don’t forget to catch the medwrite talks sessions that feature some of the most innovative and novel ideas in the field of medical communication from compelling speakers. attendees will have the opportunity to experience these sessions and more with workshops, roundtable discussions, award presentations, posters, and an exhibit hall. the return to an in-person conference for the first time in 2 years will bring back the networking and comradery that is the amwa specialty. register for #amwa2022 today for the best rates. see you in denver! author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. any views expressed in this publication represent those of the author(s) and do not necessarily represent the official views of any affiliated entity. author contact: kimberly.korwek@hcahealthcare.com kimberly korwek, phd / 2022 amwa conference committee chair reach new heights at the 2022 medical writing & communication conference conference session highlight from amwa conference committee member the description of fighting burnout at home: the hidden value of health habits begins with the phrase “you can’t work well if you are burned out”. this session has caught my attention because the boundaries between my work and home life often blur together. i know i need a reminder on how to take care of my needs and maintain a healthy balance with work. i am also looking forward to hearing about diy graphics for medical writers. i am incorporating graphics more often into data presentations these days. access to a graphic artist is a luxury that is not always available. learning how to easily create some eye-catching elements is just the thing i need to produce a high-quality deliverable. —stephanie s. wenick, mphil, wenick communications, llc http://www.amwajournal.org https://slate.com/technology/2012/01/the-nuremberg-code-set-up-to-protect-the-human-subjects-of-research-is-being-routinely-ignored.html https://slate.com/technology/2012/01/the-nuremberg-code-set-up-to-protect-the-human-subjects-of-research-is-being-routinely-ignored.html https://slate.com/technology/2012/01/the-nuremberg-code-set-up-to-protect-the-human-subjects-of-research-is-being-routinely-ignored.html https://www.cnn.com/2014/08/06/opinion/washington-ebola-zmapp-drug-africa/index.html https://www.cnn.com/2014/08/06/opinion/washington-ebola-zmapp-drug-africa/index.html https://www.amwa.org/events/eventdetails.aspx?id=1632249 https://www.amwa.org/page/conference_program v38 n1 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 61 as i write this, it’s january. there’s snow on the ground, and now that i’ve gotten through the end-of-the-year deadlines and the holidays, i’ve had a chance to look back at our conference in denver. i am so pleased that we were able to have our annual conference in person. i enjoyed talking with people face to face and attending the wonderful sessions that the 2022 annual conference program committee put together. (note that for the first time this year we recorded select sessions, which are available for purchase through the end of march.) i got to meet up with fellow members of the rocky mountain chapter for our chapter dinner, including several people i had seen only on zoom. best of all, i saw a lot of people, from newbies to old hands, enjoying their time at the conference. in addition, our medical writing executives advisory council had a successful executives forum at the annual conference. the executives forum offers programming to senior level pharma/biotech professionals whose responsibilities include recruiting, training, and managing medical communicators. a summary of what happened at this year’s forum will be in the june issue of the amwa journal. a new year has started, and we have a lot to look forward to. our diversity & inclusion assessment task force is analyzing data collected from the survey that was sent out last summer to amwa members. the task force will report back to the amwa board of directors to advise on next steps. i am eager to discover how we can improve serving our members and make sure members with a variety of backgrounds and areas of expertise are heard. one of our other great initiatives, the value of medical writing working group, continues to make great strides in defining and quantifying the value of medical writing. last year, the working group published a series of 3 articles in the amwa journal, and, at the annual conference in denver, they presented 2 posters, one on empowering medical writers and the other on measuring the success of medical writing. the working group plans to continue to create and publish tools, resources, and articles to help medical communicators develop leadership and other important interpersonal skills to empower medical communicators. look for working group updates in the amwa journal and at future amwa conferences. for those of you who like to stay connected throughout the year by attending amwa’s webinars, we are developing a great webinar schedule for this year. webinars will be announced in the biweekly amwa updates, so be on the lookout for those. finally, we’re already gearing up for our 2023 medical writing & communication conference in baltimore. we have a great location on the waterfront, and i have crab cakes and a chesapeake bay cruise on my personal to-do list. our 2023 annual conference program chair, michele sequeira, writes more about this year’s conference in this issue of the amwa journal. i hope you will be able to join me in baltimore for what i am sure will be an excellent mix of educational content and networking. from the president looking forward amwa news elise eller, phd / 2022–2023 amwa president http://www.amwajournal.org v37 n4 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 55 in partnership with the southeast, florida, and carolinas chapters, amwa’s 2022 southeast regional conference took place june 13 and 14 at the luminary hotel in fort myers, florida. the conference featured the highly rated, small group, interactive workshops that are a staple of amwa annual conferences. the popular moderated amwa freelancer jam session was also a part of the program, providing a supportive space for freelancers to share their experiences and concerns with other freelancers. attendees gathered to hear 4 medwrite talks (short presentations reminiscent of the popular tedx talk) and had the opportunity to network with other members during breakfast, lunch, and an evening reception. amwa workshops • strategies for persuasive writing workshop, susan aiello, phd, dvm, els • regulations: what does a medical writer need to know?, karen bannick mcquoid, ma, rac, fraps • advanced writing, susan aiello, phd, dvm, els educational sessions • communicating science to the public, susan aiello, phd, dvm, els • jam session for early to midcareer freelancers, jennifer minarcik, ms • public relations in medical communications, katrina r. burton, bs • resources for researching medical devices using publicly available databases, sara vanwyk, mph, ccrp, rac, mwc* • think like an editor: improving document quality for regulatory submissions, callie compton, ma • regulations: developing a clinical evaluation strategy with an eye to regulatory and quality requirements, karen bannick mcquoid, ma, fraps, rac susan krug, ms, cae / executive director, amwa 2022 amwa southeast regional conference conference medwrite talks • best practices for client interaction, sara vanwyk, mph, ccrp, rac, mwc • small business survival skills: your way to success, queen buyalos, pharmd • it’s all in how you pivot, brian bass, mwc • reminders of life lessons from the barnyard, susan aiello, phd, dvm, els http://www.amwajournal.org v37 n3 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 40 the harold swanberg distinguished service award, named in honor of one of the founders of amwa, is presented to an active amwa member who has made distinguished contributions to medical communication or rendered unusual and distinguished services to the medical profession. this year’s swanberg recipient is julia forjanic klapproth, phd. julia has made distinguished contributions to the medical communication profession. after receiving her phd in developmental neurobiology, julia forjanic klapproth started her career as a medical writer in the pharmaceutical industry at hoechst marion roussel (later sanofi) in 1997. in 2002, julia co-founded trilogy writing & consulting, a company specializing in providing medical writing of regulatory documentation. in addition to company management activities, she continues to contribute to client projects, writing a wide array of clinical documents. she has also been president of the european medical writers association (emwa) twice (2001–2002, 2007–2009) and is an experienced speaker and trainer of medical writers, regularly running workshops for emwa, giving training for amwa, and pharmaceutical companies around the world. this training covers medical writing topics, interpersonal relationships, and effective communication skills. julia has also been an amwa journal contributor, member of the medical writing executives advisory council and value of medical writing working group committees, conference presenter, volunteer since 2018, and current professional member (since 2017; carolinas chapter). as part of the senior management team at trilogy, julia supports both emwa and amwa not only by giving her time to teach, but by encouraging and supporting trilogy writers to attend the conferences and become active within the organizations themselves. julia is a staunch supporter of medical writers and has worked tirelessly to promote their standing by regularly presenting and writing about the value that strategic medical writing brings to clinical development and campaigning for better and more focused training and development specifically aimed at medical writers. for 25 years, she has contributed her expertise in writing and coordinating all manner of regulatory documents. she has authored articles on a broad range of medical writing topics. in her efforts to promote the value of medical writing and train both medical writers and clinical authoring teams on good writing concepts, she has presented at international conferences and training events on a wide array of topics. julia’s long-standing service demonstrates her passion for promoting excellence in medical communication. amwa is proud to recognize julia as the recipient of the 2021 harold swanberg distinguished service award. sarah dobney / 2021–2022 director-at-large and chair, member awards committee harold swanberg distinguished service award amwa news http://www.amwajournal.org v38 n2 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 27 it’s highly unfortunate, but for a large majority of people, their writing and editing software is basically a typewriter: most shortcuts, symbols, or things like automatic find and replace, for example, don’t exist. this is where effective onscreen editing stands out: it will make you aware of the software editing tools you have available at your disposal. it will teach you how to use them to the best of your abilities to make your work more accurate and efficient. there is a lot of content, so even if you know some about the workings of the software, you are bound to learn some very good tips. mr hart has decades of experience as an editor and was willing to share them in his book. the text is not organized around microsoft word but around editing functions within a word processing program. therefore, the book should be useful to those using other programs as well. however, word is still the most often used program for editing, so you will see the most about it. take a look at what is covered: a detailed table of contents is available at http://geoff-hart.com/books/eoe/detailed-toc. html. perhaps you will need a boost from your search engine to verify how to properly set a function up in an alternative software, but the practices introduced within the book are extremely effective regardless because they introduce the general principles and how to use them. the book also takes into account mac users and points out differences in protocols if necessary. the book covers word 2016, so anyone who orders it will also receive for free a copy of hart’s more recent book write faster with your word processor, which contains updated information on changes in word 2019. it also has a website to add updates to the content. the portions of this book i found most valuable were those that deal with tailoring your word processing program to suit your preferences when displaying documents, strategies for maneuvering quickly through a document, how to select text quickly and accurately, track changes, how to use styles and templates, using autocorrect to fill in text, leveraging find and replace tools, discussion of macros, and style sheets. additionally, hart gives good advice on adding explanatory comments to a document to communicate with the author. although learning how to use these tools properly can take a long time, it can lead to greater accuracy and efficiency in the long term, which is critical in medical writing and editing. the book also provides other advice not directly related to word processing software. the author discusses important issues such as document access, contracts, and pay rates. he also provides advice on working in teams and equipment that promotes healthy ergonomics. details on editing graphics, video, and multimedia files—mediums that are becoming increasingly common—are also discussed. the book is a very useful colossus, including its appendix of shortcuts. as a bonus, mr hart cares about keeping the book updated as word processing functions change, and he provides links to the book’s webpage. the book has a website that includes images and further information and can be regularly updated. you have access to these new explanations if you own the book. previous editions of effective onscreen editing are available to users of earlier versions of the microsoft word program. further, the book is reasonably priced and is substantially discounted for groups, students, and members of professional organizations (http://geoff-hart.com/books/eoe/ onscreen-book.htm#buy). the book is available in print, epub, and pdf formats. a digital version would be recommended so that the links in the text, as well as the clickable index and table of contents, can be easily used. a compressed version of the webpages for the book, with links to all the images and procedures, can also be downloaded so that you can work offline if you’re travelling. the book has made an impact and is now on its fourth edition. the european medical writers association gave the prior edition a very good review, with the review author saying, “this might just be the most useful book i have ever reviewed. anyone who does any kind of editing work or who wishes to use word more efficiently should strongly consider buying it.” it’s true that it takes a lot of time and effort to read the book and apply its precepts, but there are many good ideas worth incorporating into your work. it’s easy to open the book to learn how to deal with a particular issue and save time with a solution. the savings in time and the increase in accuracy should be considerable, so i highly recommend the book as well. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: alba_cid@verizon.net alba i. cid, msc / quincy, ma effective onscreen editing: new tools for an old profession (4th ed.) topical feature http://www.amwajournal.org http://geoff-hart.com/books/eoe/detailed-toc.html http://geoff-hart.com/books/eoe/detailed-toc.html http://geoff-hart.com/books/eoe/onscreen-book.htm#buy http://geoff-hart.com/books/eoe/onscreen-book.htm#buy contents v38 n3 fall 2023 3 4 7 14 20 28 33 from the guest editor overcoming obstacles and building bridges in global medical communication › elizabeth kukielka theme articles lost in translation: the vital role of medical translation in global medical communication › amanda xiaoqing mao and ishani thakkar open pharma: driving positive change in the communication of pharma-sponsored research › jo gordon science without borders – can translation tools bridge the language gap? › claire beeby, eleanor j. raynsford, and charles pollitt science series the gut microbiome–human body symbiosis: relevance of the ubiquitous microbial community on health and development, part 1 › smitha s. dutt freelance focus › brian bass, melissa l. bogen, cathryn d. evans, alex howson, and ruwaida vakil q1: what are the potential benefits and limitations of using chatgpt in medical writing, and how can these be mitigated? q2: what ethical considerations need to be taken into account when using chatgpt for medical writing, particularly in relation to patient privacy and data protection? q3: how can chatgpt be used to assist medical writers in creating patient education materials, and what challenges need to be addressed in this context? conscious writing 3 common phrases that tarnish credibility in medical writing › crystal r. herron 41 5 ipsen-sponsored publicationsa,11–15 with abstracts and plss of similar length covering a range of therapy areas and study types 4 languages translatedb a french german slovenian mandarin 4 bilingual reviewersb word selection grammar phraseology claritye non-translated additions deletions using google translate with medical writing experience evaluated 4 survey categories assessedd 20 translations per document typec 5× plss 5× abstracts misspellings phrases tone grammar/syntax punctuation symbols/units/numbers/dates accuracy likelihood of misinterpretation 诶 14 amwajournal.org 9article title figure 4. infographic: open pharma recommendations for plain language summaries of peer-reviewed medical journal publications. adapted/ reprinted from rosenberg a et al.6,7 pls, plain language summaries. more exposure for your work practitioners can apply your findings researchers in developing countries can see your work taxpayers get value for money higher citation rates your research can influence policy compliant with grant rules the public can access your findings 7 editor-in-chief michael g. baker, phd guest editor elizabeth kukielka, pharmd, mwc, cmpp managing editor rachel mosher, ma section editors progress in publications qing zhou, phd, els regulatory insights jennifer bridgers, ms, mwc science series naomi bishop, md statistically speaking thomas m. schindler, phd everyday ethics julie ravo, ba, ma freelance focus ruwaida vakil, msc ce craft corner haifa kassis, md practical matters elizabeth kukielka, pharmd, mwc, cmpp around the career block cecilia petrus, msc regular contributors freelance focus brian bass, mwc melissa l. bogen, els sherri bowen, ma, els lori de milto, mj cathryn d. evans gail v. flores, phd phyllis minick in the service of good writing laurie endicott thomas, ma, els conscious writing crystal r. herron, phd, els editors in memoriam lori l. alexander, mtpw, els, mwc ronald j. sanchez 2022–2023 president elise eller, phd 2022–2023 board liaison joanna pendergrass, dvm 2022–2023 staff liaison shari rager, ms, cae executive director susan krug, ms, cae graphic designer amy boches, biographics editorial office: managingeditor@amwa.org. instructions for authors available at: www.amwajournal.org. advertising: contact marketing@amwa.org or (240) 239-0940. all advertising is subject to acceptance by amwa and should be for products and services relevant to professional medical communicators. amwa is not responsible for the content of advertising and does not endorse any advertiser or its products or services. subscription: the amwa journal is published quarterly. subscription is included with amwa membership. nonmember subscriptions cost is $75 per year. contact: american medical writers association, 30 west gude drive, #525, rockville, md 20850-4347. phone: (240) 238-0940; fax: (301) 294-9006; email: amwa@amwa.org. the amwa journal is in the mla international bibliography and selectively indexed in the cumulative index to nursing and allied health literature (cinahl) print index and the cinahl database. the opinions expressed by authors contributing to the journal do not necessarily reflect the opinions of amwa or the institutions with which the authors are affiliated. the association accepts no responsibility for the opinions expressed by contributors to the journal. ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwa journal mission statement in support of the mission of the american medical writers association (amwa) and to advance the broader profession, the amwa journal publishes content that reflects the interests, concerns, and expertise of medical communicators. its purpose is to inform, inspire, and motivate medical communicators. m o re v38 n3 / 2023 amwa news 35 from the president › elise eller 36 officer candidate slate for the 2023-2024 election › r. michelle sauer gehring 38 amwa fellowships for 2023 › abbie miller 39 2023 john p. mcgovern award recipients jessica b. steier, drph, pmp, and andrea c. love, phd › elise eller 40 2023 walter c. alvarez award recipient katelyn jetelina, phd, mph › michele w. sequeira 41 2023 harold swanberg distinguished service award recipient joan affleck, mba › abbie miller 42 2023 golden apple award recipient hope lafferty, am, els › abbie miller 43 2023 president's award recipient don harting, ma, ms, els, chcp › elise eller 2023 conference preview 44 continuous learning and connection at the 2023 medical writing & communication conference › michele w. sequeira 45 calendar of meetings contents http://www.amwajournal.org v38 n4 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 38 abstract over the past 75 years, medical publications have included a growing number of authors. as a result, research teams face challenges in deciding who qualifies for authorship and in what order the authors should be listed. these challenges can lead to tension among research teams that is related to a large number of authors, a lack of knowledge about authorship guidelines, limited experience in research, power dynamics and work culture, and even unethical practices. to overcome these challenges, research teams may look to medical writers and editors for guidance. as a result, medical writers and editors need to be prepared to share best practices for deciding which authors qualify for authorship and which authors should be listed in the acknowledgments. medical writers and editors also need to be aware of and advise against unethical authorship practices, including honorary authorship and ghost authorship. medical writers and editors can also guide research teams in best practices for ordering authors, including understanding the meaning of author positions, determining author contributions, planning authorship from the start, establishing authorship responsibilities, agreeing on how to resolve disputes, keeping track of contributions, and documenting discussions about authorship. with this guidance, research teams can adopt best practices for ethically granting authorship and fairly ordering authors based on their contribution to the work. until the 1950s, publications were largely written by 1 author.1 since then, publications have included a growing number of authors, especially publications in medicine.1,2 between 1945 and 1988, medical publications gained 1.26 authors every 15 years (versus 0.41 authors in other branches of science).2 and across the sciences, the greater number of authors on publications has paralleled the rise in international and interdisciplinary research collaborations.3 this rise in the number of authors has created 2 important challenges. first, research teams must decide who qualifies for authorship. and second, they must figure out the order in which to list the authors who contributed to the work. these challenges can occur in any research team, but they can be exacerbated among junior researchers who are not well versed in best practices for authorship or among teams that have unethical authorship practices.4,5 to overcome these challenges, research teams may look to medical writers and editors—internal or external to the team—for guidance. to help medical writers and editors guide research teams, they need to fully understand the guidelines for authorship. they also need to be prepared to share best practices to help research teams determine who qualifies for authorship and strategies to help them determine in what order authors should be listed. who qualifies for authorship? to determine who qualifies for authorship, many journals provide guidance on their website. most often, these journals recommend that research teams use the guidelines created by the international committee of medical journal editors (icmje).6 according to the icmje, each author should fulfill all 4 of the following criteria. 1. the author made substantial contributions to conceiving or designing the work, or to acquiring, analyzing, or interpreting the data for the work; and 2. the author drafted the work or reviewing it critically for important intellectual content; and 3. the author reviewed and approved the final version of the manuscript to be published; and 4. the author agreed to be accountable for all aspects of the work, including being willing to answer questions about the accuracy or integrity of any part of the work. to ensure that listed authors meet all these criteria, many journals ask research teams to include a description of what each author contributed to the work in the manuscript, which the journal often publishes with the manuscript. but what if a contributor does not meet all 4 authorship criteria? these contributors should be acknowledged crystal r. herron, phd, els / redwood ink, llc, san rafael, ca best practices to guide decisions of authorship and author order in a research manuscript conscious writing http://www.amwajournal.org amwajournal.org 39best practices to guide decisions of authorship and author order instead.6-8 for example, contributors who supplied funding, research materials, lab management, administrative support, or writing and editing assistance may not meet all 4 criteria. these contributors should be thanked for their specific contribution (eg, provided funding, critically reviewed the manuscript, collected data) in the acknowledgments section. some research teams disregard this guidance and grant honorary authorship.5,9 in other words, they give “gift authorship” out of respect or gratitude for someone (eg, supervisor, department head) or “guest authorship” to a well-known researcher to try to amplify the quality or prestige of the paper. in some cases, honorary authorship may also be related to “pressured authorship,” in which a person of authority pressures more junior staff to include them as an author when they do not qualify.9 because these practices are unethical and can be considered research misconduct, medical writers and authors need to be prepared to advise against these practices. another type of authorship is ghost authorship. with this form of authorship, a contributor is not listed as an author, even if they made contributions worthy of authorship.5,9 this practice occurs for a number of reasons, such as an author electing to exclude themselves or a research team hiring a professional writer. the ethical nature of ghost authorship is complex and should be discussed carefully among the research team and other contributors. for example, if a professional writer qualifies for authorship based on the icmje criteria, they should be included in the author list.10 in what order should authors be listed? once a research team determines who qualifies for authorship, they must figure out in what order to list the authors. this process can be challenging, partly because ordering conventions vary between fields, guidelines, and journals. and the icmje guidelines do not provide any guidance on how to determine author order.6 some journals offer guidance that can help research teams determine author order. but with professional guidance from medical writers and editors, and some easy strategies, research teams can agree on a fair order to list the authors. the emphasis on first and last authors the 2 most coveted (ie, most valuable) positions in a publication are the first and last author positions. the first author is most often the person who has contributed the most to the work.7,8,11 this contribution can involve designing the study, performing experiments, collecting data, analyzing data, writing the manuscript, or other tasks related to the project. the last author is usually—but not always—the supervisor or principal investigator who oversaw the project.12 in some fields, the person who oversaw the project may be listed as the first author. the person who oversaw the project often receives much of the credit when the project is successful, or the criticism when something goes wrong. the importance of corresponding author the corresponding author is the person who takes primary responsibility for communicating with the journal. they ensure that all required information is submitted to the journal, and they receive all updates related to the submission, such as the status, reviewers’ comments, and final decision.6 the corresponding author is often the person who oversaw the project, so most research teams will designate the last or first author as the corresponding author.13 the relative contribution of in-between authors between the first and last author positions, authors are usually listed according to their relative contribution to the work, from the most to the least.7,8 to determine this order, many research teams use a mathematical approach. they will choose which items will appear in the manuscript, determine how much each author contributed to those items, and then rank the items based on their importance to the manuscript. then, they will calculate each author’s total contribution to the manuscript and order the authors from the most to least contribution. the challenges of equal contribution in some cases, research teams believe (or calculate) that more than 1 author contributed an equal amount to the work. and this equal contribution can apply to any position in the author order, including the first and last positions. some journals will let research teams indicate whether authors contributed equally to the work. but even then, the team has the (sometimes daunting) task of choosing the order of the authors who contributed equally. this task can be even more challenging when the equal contribution applies to the coveted positions of first or last author.14 for example, the first “first” author will get more visibility than the other “first” author because the first “first” author is the first—and sometimes only—name a reader will see. this same challenge can occur with the last author position, because the last “last” author often gets the most credit for the work. what can you do to settle a debate about equal contribution? a simple approach is to just list them alphabetically, although the use of this approach has declined over time.15 some research teams will order authors who contributed equally by their seniority in the group, the degree of difficulty needed to carry out a specific part of a project, or a combination of these approaches. and other teams get creative. for example, a researcher at stanford university http://www.amwajournal.org amwajournal.org 40best practices to guide decisions of authorship and author order had 2 researchers in his laboratory play 3 games, and the winner was given the first slot.16 this approach is certainly not conventional, but it added a fun spin to an otherwise daunting task. how can teams prevent authorship conflict? discussions of authorship and author order can lead to conflict among research teams. and this conflict is influenced by a variety of factors, including power dynamics, experience in research, and the culture in the institution, department, or laboratory.4,5 to navigate these conflicts, medical writers can guide research teams to use the following best practices. plan authorship from the start the best way to mitigate any issues in granting authorship and ordering authors is to plan authorship from the beginning of the project, before the writing or even the research project starts.7,8 during an initial meeting with the research team (or an established committee for larger studies),17 discuss the icmje guidelines and define what is considered a contribution that qualifies for authorship in the context of the project. this approach ensures that all potential authors know the expectations—and potential consequences of not meeting them—from the start. establish authorship responsibilities in planning authorship, discuss and clearly define the roles and responsibilities of each author (ie, who will do what), with the caveat that these contributions may change as the project evolves. these discussions could be facilitated by creating a modifiable authorship grid that clearly outlines the responsibilities and contributions of each potential author.18 this grid could be informed by standard taxonomies of author contributions.19,20 agree on how to resolve disputes before a potential dispute occurs, discuss how the team will resolve disputes that may arise. this discussion will ensure that the team has an objective approach to manage a dispute. for example, the team could agree to resolve disputes with a neutral third-party, such as an administrator or researcher far removed from the work.12 or the team could get creative, as the stanford researcher did, by having 2 authors play a game to determine the author order.16 keep track of contributions as the project and writing progress, keep track of everyone who contributed to the work and how they contributed. then, at regular intervals or major milestones, discuss authorship and whether your team might need to make adjustments to ensure all contributors qualify for authorship based on the icmje guidelines. if the team is using an authorship grid18 or other tracking method, be sure to update the tracker with each discussion. document discussions about authorship to ensure a smooth authorship process, summarize all discussions in an email or document so they can be tracked. ask all potential authors to review this document and agree, in writing, with the described details. this approach will ensure all authors stay aware of their contribution to the project. then, when submitting the manuscript, declare the authorship contributions (and even clarify the order of authors)12 in the manuscript where appropriate. conclusions authorship can be a source of tension among research teams. this tension may be related to the rise in the number of authors, knowledge of authorship guidelines, experience in research, power dynamics and work culture, and even unethical practices among teams. with guidance from medical writers and editors who are well versed in authorship best practices, research teams can adopt procedures for ethically granting authorship and fairly ordering authors based on their contribution to the work. author declaration and disclosures: the author does not have any commercial associations that may pose a conflict of interest related to this article. author contact: crystal.herron@redwoodink.com references 1. rennie d, yank v, emanuel l. when authorship fails. a proposal to make contributors accountable. jama. 1997;278(7):579-585. doi:10.1001/jama.1997.03550070071041 2. onwude jl, staines a, lilford rj. multiple author trend worst in medicine. bmj. 1993;306(6888):1345. doi:10.1136/ bmj.306.6888.1345 3. fanelli d, larivière v. researchers’ individual publication rate has not increased in a century. plos one. 2016;11(3):e0149504. doi:10.1371/journal.pone.0149504 4. cutas d, shaw d. writers blocked: on the wrongs of research co-authorship and some possible strategies for improvement. sci eng ethics. 2015;21(5):1315-1329. doi:10.1007/s11948-014-9606-0 5. bozeman b, youtie j. trouble in paradise: problems in academic research co-authoring. sci eng ethics. 2016;22(6):1717-1743. doi:10.1007/s11948-015-9722-5 6. international committee of medical journal editors. defining the role of authors and contributors. international committee of medical journal editors. accessed june 2023. https://www. icmje.org/recommendations/browse/roles-and-responsibilities/ defining-the-role-of-authors-and-contributors.html#two 7. christiansen s, iverson c, flanagin a, et al. ama manual of style: a guide for authors and editors. 11th ed. oxford university press; 2020. http://www.amwajournal.org https://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html#two https://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html#two https://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html#two amwajournal.org 41best practices to guide decisions of authorship and author order 8. american psychological association. publication manual of the american psychological association. 7th ed. american psychological association; 2020. 9. bennett dm, taylor dm. unethical practices in authorship of scientific papers. emerg med australas. 2003;15(3):263-270. doi:10.1046/j.1442-2026.2003.00432.x 10. amwa‒emwa‒ismpp joint position statement on the role of professional medical writers. published online january 2017. accessed april 12, 2023. https://cdn.ymaws.com/www.amwa.org/ resource/resmgr/about_amwa/jointpositionstatement.profe.pdf 11. tscharntke t, hochberg me, rand ta, resh vh, krauss j. author sequence and credit for contributions in multiauthored publications. plos biol. 2007;5(1):e18. doi:10.1371/journal. pbio.0050018 12. smith e, master z. best practice to order authors in multi/ interdisciplinary health sciences research publications. account res. 2017;24(4):243-267. doi:10.1080/08989621.2017.1287567 13. baerlocher mo, newton m, gautam t, tomlinson g, detsky as. the meaning of author order in medical research. j investig med. 2007;55(4):174-180. doi:10.2310/6650.2007.06044 14. strange k. authorship: why not just toss a coin? am j physiol cell physiol. 2008;295(3):c567-c575. doi:10.1152/ajpcell.00208.2008 15. waltman l. an empirical analysis of the use of alphabetical authorship in scientific publishing. j informetr. 2012;6(4):700-711. doi:10.1016/j.joi.2012.07.008 16. conger k. who’s on first? duking out scientific paper authorship order. scope blog. published december 13, 2021. accessed february 15, 2023. https://scopeblog.stanford.edu/2021/12/13/ whos-on-first-duking-out-scientific-paper-authorship-order/ 17. marušić a, hren d, mansi b, et al. five-step authorship framework to improve transparency in disclosing contributors to industrysponsored clinical trial publications. bmc med. 2014;12:197. doi:10.1186/s12916-014-0197-z 18. phillippi jc, likis fe, tilden el. authorship grids: practical tools to facilitate collaboration and ethical publication. res nurs health. 2018;41(2):195-208. doi:10.1002/nur.21856 19. allen l, scott j, brand a, hlava m, altman m. publishing: credit where credit is due. nature. 2014;508(7496):312-313. doi:10.1038/508312a 20. credit. national information standards organization. accessed april 12, 2023. https://credit.niso.org/ get fit with amwa f ast i nteractive t raining amwa’s fit series helps medical communicators stay healthy. in only 15 minutes—jog your memory, tone your writing muscles, build your core skills, and stretch your knowledge. www.amwa.org/fit only $15 each / approved for .5 ce topics in the series include: } misplaced modifiers } mean, median, and mode } dangling participles } measures of variability http://www.amwajournal.org https://cdn.ymaws.com/www.amwa.org/resource/resmgr/about_amwa/jointpositionstatement.profe.pdf https://cdn.ymaws.com/www.amwa.org/resource/resmgr/about_amwa/jointpositionstatement.profe.pdf https://scopeblog.stanford.edu/2021/12/13/whos-on-first-duking-out-scientific-paper-authorship-order/ https://scopeblog.stanford.edu/2021/12/13/whos-on-first-duking-out-scientific-paper-authorship-order/ https://credit.niso.org/ v37 n4 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 52 when i learned about the field of medical writing and attended my first amwa conference, i knew i had found my people. however, i had no idea at the time that i’d someday be president of amwa. i am humbled to follow in the footsteps of so many other amwa presidents, people i have worked with and admire. and i am grateful for the people who will work with me and offer their expertise this year: my fellow officers and the rest of the amwa board of directors; committee chairs and members; susan krug, our executive director; and the amazing amwa staff. i first heard about amwa when i talked to a freelancer in my area, julie gelderloos, about medical writing. julie convinced me to join amwa and attend my first conference in 2009 in dallas. i’ve attended the amwa annual conference ever since. when the then-president of the rocky mountain chapter, barb zimmerman, asked me to organize the next chapter conference, i said yes. and that’s how i got sucked in. i later served as chapter president and got involved at the national level, including chairing a chapter handbook committee. after serving at the chapter level, i joined the amwa board of directors and served in various roles. i say this not to establish my credentials but to point out a common theme: each time, someone asked me to do something, and i said yes. with the guidance of our executive director, susan krug, and the hard work of amwa staff and volunteers, we have weathered the pandemic surprisingly well. as we come out of the pandemic, we are revitalizing our volunteer opportunities. amwa’s call for volunteers opened in late september. without our volunteers, our organization would not accomplish as much as we do. you, our members, are amwa. we need our members to help us accomplish our goals and build upon what we’ve already achieved. volunteer opportunities include but are not limited to selecting content for the annual conference, developing and evaluating educational content for our workshops and online learning, working for the amwa journal, participating in committees and task forces, and volunteering at the chapter or local level. opportunities range from microvolunteering to year-long commitments. we also want every member to feel welcome in amwa. recently, we launched a diversity, equity, and inclusion initiative to determine how we can make sure a diversity of voices is heard within our organization. everyone has their own experiences, both personal and professional. everyone has their own story. we value our welcoming and collaborative environment in amwa, but there is always room for improvement. our mission remains promoting excellence in medical communication. to pursue this mission, we need volunteers with a variety of backgrounds and areas of expertise. i am excited about the upcoming year and am looking forward to seeing what we accomplish. we have a conference in baltimore to plan and new and refreshed educational content to put out. we are constantly reviewing our educational offerings to determine what is of value to our members. the amwa journal is now using a new digital publishing platform and is updating its processes to improve efficiency and enhance the reader experience. we have important initiatives in the works, including the value of medical writing initiative and our diversity, equity, and inclusion initiative. in short, there’s lots to do. to all of those people along the way who asked me to volunteer for various roles, thank you. i said yes, and i have never regretted it. and to my readers i say: say yes. you have a place in amwa. from the president inaugural address: say yes amwa news elise eller, phd / 2022–2023 amwa president we need our members to help us accomplish our goals and build upon what we’ve already achieved. http://www.amwajournal.org v37 n3 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 44 the walter c. alvarez award is named in honor of walter c. alvarez, md, a pioneer in the field of medical communication. the award is presented to either a member or nonmember of the american medical writers association (amwa) to honor excellence in communicating health care developments and concepts to the public. the alvarez award is presented during amwa’s medical writing and communication conference. hello. i want to begin by thanking the american medical writers association (amwa) for the walter c. alvarez award. i’m deeply honored and very happy to join this august company of award winners. i’d like to share with you a bit of my odyssey as a medical writer, including some of the very important influences on my work and on my perspective. my odyssey as a journalist and medical writer has been one of expanding my perceptions of what that means. like many people, i became interested in both science and then writing early on. although i wasn’t quite sure how to integrate these 2, i perceived becoming a medical writer as a mission of translating science for everyday people and helping them to make the best decisions for their health and welfare and for that of their family and of society. that certainly is an important part of our mission, but with science comes human values. i also have embarked on a discovery of things beyond pure science—human endeavors, human concerns, human biases and limitations, as well as human ethics and goals and motivations that also affect our role as medical communicators. now it seems rather clear to me that science is not limited to data—a compendium of information and a bloodless analysis—but rather, it appropriates every human endeavor. moreover, it’s not only the values of humanity that affect science but also its limitations. the same limitations that cause people to express bias, prejudice, a narrowing of one’s perceptions, a narrowing of one’s horizons…these things affect science, too. as thomas kuhn, author of the structure of scientific revolutions tells us, aside from the strictly logical theories and hypotheses that enchant us all and that we rigorously adopt, there’s also the effect of politics and of racial concerns and concerns around gender. anything that affects human societies also weighs in and has some effect on the science that emanates from them. winston churchill probably said it most succinctly when he pointed out that “history is written by the victors.” we have a view of scientific endeavor and achievement and even science’s purpose, that is shaped by the values of people who are triumphant, who are dominant, who are telling their story through the history of science and through science as an endeavor. harriet a. washington, ma / writer and medical ethicist, fellow of the new york academy of medicine, new york city, ny 2021 walter c. alvarez award address the journalistic structure of medical revolutions conference image 1. carte blanche, as well as other books written by harriet a. washington, and an article written by washington on the removal of the statue of dr james marion sims in new york city’s central park. http://www.amwajournal.org amwajournal.org 45the journalistic structure of medical revolutions dr felix okoye, a professor of african history, said basically same thing: “don’t let the lion tell the giraffe’s story.” as we look at the history of science, a history whose first draft is written by medical journalists, we come to understand that much more than bloodless numbers affect science. i didn’t know this at the beginning. at the beginning, i was given a very different idea of my mission as a medical writer. who can be a scientist? who can interpret science? my first job as reporter was at my college newspaper, like a lot of people. i was quickly confronted—in a polite but very powerful way—by the editors who gathered together to talk to me. the only thing they had to say was, “how can you be an objective journalist?” this was the 1960s, a time of racial tension on campus, and they pointed out that as an african american, i would almost certainly be promulgating the experiences and the aims of african americans, and i could not be objective. and if i could not be objective, how could i be a good journalist? i was a bit shocked by that and quickly pointed out that one could say that of any ethnic group; i mean, why are you singling me out? i didn’t understand why they were singling me out at the time. later, i came to understand that it had to do with who is perceived as someone who can be a scientist, and for that matter, who can be a journalist. we’ve long had the attitude in society that only certain people can be scientists, that objectivity is out of reach for certain people. notably, for a time, we thought women could not be objective for various reasons, and it was also felt that african americans couldn’t be objective. but one’s definition of “objectivity” actually shrouds the uglier bias: that certain people are simply not equipped to craft an analysis that is devoid of unwanted emotional or social perspective that would “pollute” pure science. donna haraway articulated this point very powerfully when she pointed out that the word objectivity has come to stand for, in many cases, the requisite tone of the white male scientist, who was assumed to be without these kinds of encumbrances, to be objective by nature. that’s actually a flaw in our society—we assume certain people can be objective by nature. of course, objectivity itself, as we know, is a bit of an elusive goal. this idea of who can be a scientist spills into who can be a medical journalist. for a while, i tried to hew to this ideal of someone who was demonstrating that yes, i can be objective. yes, i can discuss things without invoking the messy business of race or of social frictions or, for that matter, of women’s concerns. discussing the science, writing about science, analyzing science, without polluting it with these concerns, became something that i set as a goal for myself. it was a goal shared by many of the people that i wrote for and worked with. i remember, around the same time, in the 1970s, being told that medicine was an unrealistic career goal for me. i originally wanted to be a doctor, but i was told that no, there were no black women doctors, and black women were simply not suited for medicine, without more explanation than that. so having sterling grades and all the experiences that one would normally associate with being a good candidate didn’t seem to matter. i simply was constitutionally not an appropriate candidate. at 16 years old, i didn’t know any better. i’ve never since let someone tell me what i can and can’t do in that manner. up to that point, i was used to being encouraged by my academic guides and leaders and teachers, so i believed them. i don’t believe them anymore. and as i matured and learned more about who can and cannot be a chronicler of science and what is and isn’t an appropriate addition to science, i began to understand that my mission had changed. my mission was no longer to be a translator, simply translating science without any presumptions or bias, but to analyze and also criticize science when it was appropriate. academe as catalyst criticizing science was very difficult because doing so seemed to evoke hubris. and yet i saw racial bias in the hospital that i worked in during the 1980s. i also saw racial bias in reporting about medicine and science. this troubled me. how do you counter that and still adhere to promulgating scientific rigor? i felt it must be possible, but i didn’t see examples of this until i was fortunate enough to land a journalism fellowship at harvard school of public health (hsph) in 1992. they selected 3 medical journalists a year. the years at hsph inspired me to venture beyond translation and focus on divining the medical truth by navigating conflict of interest, financial bias, sexist, and later, racist assumptions. i was exposed to thought leaders, “the key role of writers in the evolution of medical thought and practice has been both exaggerated and, at key junctures, effaced. writers are blamed for failings that they share with an inherit from scientists. medical news has been a catalyst for change when it revealed momentous events such as ‘mississippi appendectomies,’ the abuses at willowbrook, and the usphs study at tuskegee.” – harriet a. washington http://www.amwajournal.org amwajournal.org 46the journalistic structure of medical revolutions public health leaders, ethics leaders, very powerful, brilliant people who were advancing public health and medical ethics. the director, bob meyers at the time, was deeply invested in us and in our holistic education as medical writers. he put me in touch with people like jonathan mann, larry gostin, allan brandt. this opened an entire world for me. i began to see my mission as something that encompassed both my desire to address troubling facets of medical problems in this country and also being true to my desire to be a rigorous chronicler of science. none were so transformative as marcia angell and patricia thomas. we were lucky enough to meet marcia angell while she was editor of the new england journal of medicine. by challenging the conventional wisdom that medical practice and research were purely motivated by scientific rigor, she pointed out the immense corporate influence on any number of conflicts of interest, which had nothing to do with scientific accuracy and everything to do with promulgating power and money in the hands of people who held it. in meeting her and hearing her talk about her work so fearlessly, i felt i’d been given permission to look into things that troubled me, to see whether they were as accurate and rigorous as i’d been told or, perhaps, whether they were also being affected by conflicts of interest. and that was revelatory. patricia thomas, who was then editor of harvard health letter, commissioned me to write some pieces, but i learned more from her than simply as a medical editor. she was also challenging conventional wisdom, in part by looking at the reporting around women’s issues. and one of the very basic tenets was that very often journalists were writing reports that did not include the perspective of women’s health experiences. thomas, who took me to my first amwa meeting in 1993, helped me to see beyond the role of translation and generating accurate useful messages from medical journals, to then seeing the unsupported assumptions, subtle and missing data, unasked questions. an example was the “inappropriateness” of including women in research because of their hormonal fluctuations, pregnancies, and monthly cycles—messy things that would disturb the pristine data, conclusions, and health portrait that could be gleaned only by investigating that 150–pound white male. and just like marcia angell, thomas was fearless and pointed out that this is wrong—you’re excluding more than half the population and emerging with a very inaccurate picture. these fearless women, these fearless scientists, made me see that my mission was something deeper. i wanted to certainly promulgate medical truth, but i also wanted to look at deeper truths. how were women being mischaracterized and affected by medical missteps? how were people of color being affected? that became my mission which i have devoted myself to for 20 years. i could not have done it without the examples set by these other scientists early on. i followed this up with a few years at harvard medical school where i was a medical ethics research fellow and emerged with my first important work, which was medical apartheid, essentially a correction of the history of medicine, which has systematically excluded the experience of people of color. i went on to teach ethics at columbia university. i teach a course on journalism and bioethics in which i talk about parallels between medicine and journalism. very often we find scientists and physicians accusing journalists of sensationalism. quite frankly, i can’t say that we were innocent, but they also share these limitations. i remember, very frequently, having articles disparaged by scientists who’ll say, “ah, that’s not accurate,” and more to the point, “it’s written to sell more papers and attract more attention.” and yet, at the school of public health, i remember during the very first year being mystified by how many professors who, after having the students introduce ourselves, would flock to me. they didn’t flock to the people who were brilliant, had done research, worked in the developing world, done all kinds of fascinating science. they flocked to me because they wanted media attention. a lot of these scientists had biotech companies, and they understood that media attention could help them to attract investors, and they wanted to know if i could help them do that. there’s nothing wrong with seeking attention if it doesn’t interfere with the accuracy and ethics of your work. but to accuse journalists of that when the field itself engaged in it is really not fair. when i worked at usa today, i interviewed a doctor who astonished me by asking, “can you get me on oprah?” he also was seeking attention for his work. i had been told that when i worked at usa today, any scientist i called would call me back immediately. that had not been my experience, but they would call back because it was usa today, which at that time had a large circulation. therefore, accusations of sensationalism or sloppy reporting can frankly go in both directions, as can less than rigorous standards. it’s important to remember that and perhaps not become defensive about it. an apology and a banishment during the 20 years that i have done the work i felt greatly blessed and enabled to do by meeting these fearless scientists, there have been a few things that stand out as http://www.amwajournal.org amwajournal.org 47the journalistic structure of medical revolutions especially significant. one was a 2008 apology from the american medical association (ama) to the nation’s black doctors based on a paper that my coauthors and i wrote and published in the journal of the american medical association (jama) in july 2008.1 i then popularized the report findings in a piece i wrote for the new york times. the apology was a good sign, but what’s really important about apologies is what happens afterward. in this case, what happened afterward was very promising. there were a few projects that ama and the national medical association worked on together, a committee to end health care disparities and such things, that were the lasting significant events emanating from that apology. the other event that i’m especially satisfied with was in 2018, the banishment of the statue of dr james marion sims from central park. this was after i had detailed the unethical nature of his research with enslaved black women who, of course, could not give consent. the statue sat right across from the academy of medicine in new york. women living in the area—mostly black and hispanic women—ceaselessly besieged city hall and the parks department to have the statue removed. they did so with assistance from mostly white medical students who also lived in the area. this happened 10 years after i had given a talk at the academy of medicine in which a medical student jumped up and said we ought to tear his statue down. these are 2 really important things i have had a role in bringing attention to. an erosion of informed consent, a call to action i’m still working on the third thing, and it is something that i hope other medical writers will find worthy of looking into. in fact, we might need a groundswell of attention. it’s my contention that informed consent is waning in us research. two laws have passed that formally allow research to be legally conducted without people’s permission or without, even, their knowledge. and many, many enterprises are burgeoning. erosion of consent2,3 • department of defense obtained a waiver to force 8.9 million ground troops headed to the persian gulf to be inoculated with experimental anthrax vaccines. (1990-2005) • poor black women in north carolina were forced into racialized nonconsensual drug studies. (1994) • new york city law enforcement officials helped researchers to coerce black parents to enroll their boys in a study that south to establish a genetic propensity for violence without their consent. (1994-1995) • modifications to the code of federal regulations (21 cfr 50.24) permits investigators to conduct research with trauma victims without their knowledge or consent. (1996) • northfield laboratories ran a national trial in which ambulance crews randomly administered blood substitute polyheme to unconscious victims of car accidents, shootings, and cardiac arrests. (2003) • resuscitation outcomes consortium is recruiting 21,000 subjects in the united states and canada to test experimental drugs and devices for severe injury and cardiac arrest without consent. image 2. screenshots of articles washington has written on lack of consent in medical research. http://www.amwajournal.org amwajournal.org 48the journalistic structure of medical revolutions my concern is that there is little attention to this—people simply don’t know. unless we take a stance and examine this ethically and determine whether it’s the way we want to conduct medicine and science in this country, i’m afraid people won’t realize it until it’s too late, until we’ve lost informed consent. i don’t know if you’ll agree with me, but i hope that people will at least think about this and whether they think it’s worth their time. here’s a copy of the article that we wrote for jama detailing the treatment of african american doctors by white doctors and the new york times article accompanying that. and here are some pieces i wrote about how informed consent is being slowly and insidiously taken off the table in american medical research. and here’s the book i published just this year, carte blanche, in which i talk about the erosion of informed consent, how the law is allowing informed consent to be dispensed with, and how the pandemic is, not surprisingly, escalating this tendency. i want to share an image with you. dr sims’ statue was carted away from central park and banished to brooklyn, out of sight, and i was there. research in the developing world the final thing i wanted to touch on is something that medical journalists should be writing about more frequently and, perhaps, should take a departure from much of the ethical literature. we are using the developing world more and more frequently to conduct research on which our medications are predicated. and yet, informed consent in the developing world, is—if anything—less frequently observed than it is in the united states. that’s been a concern for a very long time. some researchers, for a very long time, have cast a rather jaundiced eye toward informed consent in the developing world, offering various reasons why it’s not appropriate, or efficient, or convenient. but the question is, is it right? is it ethical to dispense with it? i say no. i think that sometimes we have failed to understand the ethical breaches because they’re cloaked in language that hides them. if you look at the 2014 west african ebola epidemic, the outbreak was deeply concerning, not because of the loss of life, the many illnesses, but because there was a potential remedy, zmapp, that was being promulgated. only a few doses were available and discussions about who would get the medication troubled me greatly. there was a consensus that it should be given to white and western caregivers and not be given to west africans. the excuses covered the gamut. some people said the caregivers have to survive in order to treat people, so they should get it first. i can see prioritizing them, certainly. but withholding it from africans was excused by saying that, well, africans don’t really trust western medicine, it would be a waste, they wouldn’t take it anyway, they wouldn’t take it properly. and some people, including dr kent brantly, who treated west africans and contracted ebola, said they can’t really understand the informed consent as i can. at the end, brantly received it, but sierra leone’s chief virologist, dr sheik umar khan, was never told it was available. he died without ever receiving zmapp. the discussion around that was rather uninformed sometimes. one cnn doctor–journalist said, you can’t give it to africans because the medication has been only tested in monkeys, and now if you give it to africans, people will say that that sounds racist. and i thought, surely, he must know that by law, every medication must be tested in animals first. i don’t know if he did or not. but his opinion seemed to carry the day. i had a discussion with cnn about it.4 interviewer: you know, you bring up a point that i have certainly heard among some friends of mine just asking this question, you know, who is it to decide, at the end of the day, who lives, who dies. who gets this drug if, in fact it, you know, manages to help these americans or not? washington: right. well, that is the obvious question. and certainly, no one intends to withhold the drug from africans. but for economic and historical reasons, that is precisely what tends to happen. it’s not an accident that they, so far, have not had access to it, which i hope will change as more becomes available. there are economic reasons, a network, to which westerners tend to have access but not people from developing countries that influences who gets scarce drugs. interviewer: let me flip the script because we could be having, harriet, a very different discussion if the headline instead were “experimental drug only used in monkeys and now being tested on west africans.” i mean, i think that there would be outrage that people would be saying they’re being used as guinea pigs. image 3. sims statue being removed from central park. http://www.amwajournal.org amwajournal.org 49the journalistic structure of medical revolutions washington: well, those people would be wrong because it happens all the time. we have to remember that the way our system of testing drugs is designed, some people are always the first to get a drug. and increasingly, those people are people in the developing world where now 2 out of every 5 clinical trials are being held… so, it’s frequently the case that these people are the first to get a drug that’s been tested in animals. and that’s perfectly acceptable—we’ve decided those are acceptable risks. what is important and what is not acceptable, sometimes, is the way in which the trials are administered and conducted. interviewer: what about the drug maker itself and the fact that, you know, this had only been tested, according to sanjay gupta, you know, in monkeys and now this is the first time it’s being used in humans. your point just being that this happens—we just don’t talk about it as often? washington: no, my point is that this is actually more akin to the normal course of things than it looks. our clinical trials are set up so that every drug that is tested in humans has to first be tested in animals. but if you think about it, some group of humans is always the first group to get the drug tested in them before any other humans. so, there’s always a case that there are…are people who are initially tested. the questions arise when who these people are seems to be a product of some kind of bias, whether it’s intentional or economic or some other kind of bias. and when the testing violates ethical principles that are very well entrenched like informed consent, what we are frequently hearing about, in the third world, are trials in which there’s not informed consent. as we would expect to have in connecticut, someone explain to us, according to our laws, what the drug is, what the known side effects are, what the possible results of taking a drug are, all the possible options of taking a drug, these are very carefully spelled out in our law in the code of federal regulations. but once researchers begin testing drugs abroad, all too often, these rules fall by the wayside, and there’s not as much oversight, so it’s easy to cut corners abroad. that is actually the problem—not the fact that some people become the first group to get the medication. interviewer: i’ve got it. today we remain in the throes of difficult ethical decisions about the people in the developing world who are testing medications, making them possible for us to use, and then ending up without access to those medications themselves. what we’re going to do will be the result of how well we’re able to analyze what’s happening and what the various people’s rights and needs are. medical journalists will play a key role in that. if we thoroughly look at all the issues and promulgate them, whether or not these are the issues being discussed by doctors and ethicists, then we will have fulfilled our mission to help us make the best decisions. if we fail to do that, then we will not. i want to express, in closing, my deep, deep gratitude at not only having had the chance to pursue things that i think are really important but also to widen my horizons to be able to address what i think is important. whether or not i look objective enough to suit other people, the example of the seminal scholars that i’ve learned from and the seminal writers who have fearlessly explored what they thought was key—without regard to what others thought about their objectivity—has meant everything to me. again, i thank you very much. and thank you for listening to me. acknowledgment i thank nadine odo, ccrc, els, facrp, medical writer and author’s editor, augusta university, for her help in bringing the transcript to the page. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: haw95@aol.com references 1. baker rb, washington ha, olakanmi o, et al. african american physicians and organized medicine, 1846-1968: origins of a racial divide. jama. 2008;300(3):306-313. 2. washington ha. non-consenting adults. slate website. published january 22, 2012. accessed october 2021. https://slate.com/ technology/2012/01/the-nuremberg-code-set-up-to-protect-thehuman-subjects-of-research-is-being-routinely-ignored.html 3. washington ha. carte blanche: the erosion of medical consent. columbia global reports, 2021. 4. washington ha. make more ebola drug and give it to africans. cnn website. published august 6, 2014. accessed october 2021. https://www.cnn.com/2014/08/06/opinion/washington-ebolazmapp-drug-africa/index.html http://www.amwajournal.org a podcast to discuss topics important for the profession of medical writing available on apple podcasts, google podcasts, spotify, and trilogywriting.com/trilotalk https://trilogywriting.com/trilotalk/ american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. v38 n2 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 59 following is amwa’s financial report for the 2021-2022 fiscal year, which ended june 30, 2022. this past year has been successful in many ways (membership growth, successful virtual events, continued engagement of medical writing executives, support for the value of medical writing projects, new d&i initiative, etc.) we continued to enhance marketing and social media efforts and implement new strategies to promote programs. we exceeded income for almost all our revenue-generating programs by creating valuable and timely content, resources, and member benefits. based on the number of attendees and positive evaluation results, we had a very successful 2021 virtual annual conference. the evaluation results for this event were overwhelmingly positive, and we exceeded all income categories. financial performance net income from program operations was $335,422 versus a budgeted net loss from operations of ($18,700). amwa reported a net loss for the 2021-2022 fiscal year of ($38,874) that was due to a significant investment loss of ($486,697). revenues overall, program revenues of $1,806,892 exceeded budget expectations by 9%. this was largely because of conservative income budget estimates. membership, annual conference, and education/certificate program income continue to be amwa’s major sources of revenue, providing 87% of amwa’s program revenue (figure 1). expenses amwa invests in programs, products, and services that bring value to members and the medical writing community. overall, program expenses were under budget by 12% for the fiscal year. total program expenses for the fiscal year were $1,474,826, with 32% of the expenses being used to fund membership benefits, 18% of expenses being used to produce the virtual annual conference, 16% of expenses funding educational programs including the essential skills certificate program and online education, and 7% being used to produce the journal (figure 2). reserves reserves are the accumulation of funds over time that enable an organization to withstand an emergency or to invest in new mission-related initiatives. unrestricted reserves of 6 to 12 months of annual operating expenses represent a standard target for not-for-profit organizations. budgeted annual operating expenses were $2,236,000 for the fiscal year beginning july 1, 2022, to june 30, 2023. amwa’s unrestricted shortand long-term investment reserve level of $2,728,821 on june 30, 2022, provided sufficient reserves to cover 6 to 12 months of operations. amwa’s restricted endowment and mcgovern funds totaled $214,906 and $172,541, respectively. financial position an organization’s financial position is reflected in its asset and liability holdings. amwa is well positioned to pay its obligations and plan for the future. total assets were amwa annual financial report, 2021-2022 julie phelan, md, mba / 2021-2022 amwa treasurer amwa news membership 43% annual conference 24% education/certificate program 20% all other revenue 13% membership 32% annual conference 18% journal 7% all other expenses 27% education/certificate program 16% figure 2. sources of major program expenses for the fiscal year that ended june 30, 2022. figure 1. sources of program revenue for the fiscal year that ended june 30, 2022. http://www.amwajournal.org amwajournal.org 60amwa annual financial report, 2021-2022 $4,172,530 as of june 30, 2022, and the organization’s liabilities totaled $775,481. financial statement audit results abercrombie and associates, amwa’s independent auditors, expressed an unqualified opinion regarding their audit of the financial statements for the fiscal year that ended june 30, 2022. an unqualified opinion states that the financial statements present fairly, in all material respects, an entity's financial position, results of operations, and cash flows in conformity with generally accepted accounting principles. amwa remains in a secure financial position as it continues expanding member benefits and resources into the next fiscal year. the full audit report is available to amwa members upon request. acknowledgment i thank calibre cpa group, pllc, for providing the financial data and the members of the 2021-2022 budget and finance committee for their review of reports and budgets: june baldwin, karen bannick mcquoid, alice pappas, whitney smalley-freed, laura town, and christine wogan; as well as ex-officio members: katrina burton (2021-22 amwa president), elise eller (amwa president-elect), and susan krug (amwa executive director). author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: julie@biomedisysinc.com get fit with amwa f ast i nteractive t raining amwa’s fit series helps medical communicators stay healthy. in only 15 minutes—jog your memory, tone your writing muscles, build your core skills, and stretch your knowledge. www.amwa.org/fit only $15 each / approved for .5 ce topics in the series include: } misplaced modifiers } mean, median, and mode } dangling participles } measures of variability http://www.amwajournal.org v38 n2 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 57 as i write this, the amwa board of directors (bod) is preparing to meet in rockville, maryland, for its spring board meeting. it’s always a pleasure to see my fellow board members and amwa staff in person. i’m also excited because the amwa bod will review and discuss recommendations from the diversity & inclusion assessment task force. the amwa bod reviewed preliminary findings from amwa’s 2022 diversity, equity, and inclusion (dei) survey at its meeting in january. one of the things respondents felt would be most helpful for amwa to cultivate a more inclusive culture is to provide programs and resources on dei topics. providing education and resources is solidly in amwa’s wheelhouse, and i am pleased that amwa has already begun to offer this educational content, and we plan to develop more. our monthly webinar series has included dei topics, and we had educational sessions, roundtables, and posters related to dei at the 2022 medical writing & communication conference. i understand that there are several proposals on dei topics for our upcoming annual conference in baltimore, maryland. i thank everyone who has stepped forward to share their expertise in this area. survey respondents also shared what would be most helpful to them as medical communicators. these include resources on using inclusive language in medical communication, on how to develop inclusive health communication, and on health equity and health disparities. if you have expertise in any of these topics or can recommend someone with expertise, please reach out to amwa staff. we can use you, whether it’s a webinar, online learning, or conference content. the amwa journal is another venue to showcase your expertise. the survey respondents also indicated that amwa should strive to have a more diverse representation in leadership and among subject matter experts (eg, amwa journal article and blog authors, conference and online education presenters). to keep our organization strong, we need to continuously cultivate new leaders and encourage a diversity of voices in our leadership. many amwa leaders got their start at the chapter level— chapters always need volunteers! if you are in a chapter and would like to be more involved, consider volunteering for a task, whether it’s printing out name tags for your chapter’s conference, organizing a networking or educational event, or serving on a chapter committee. members can also develop leadership skills by volunteering at the national level, such as volunteering for the amwa journal or serving on a committee, task force, or working group. as volunteers gain experience, they might want to further develop their leadership skills by chairing a committee, task force, or working group. from there, leaders might want to apply to serve on the amwa bod, where they will need to think strategically on behalf of the organization. in short, activities range from the operational and logistical to management to strategic, and volunteers need to consider what skills they have and want to develop further as well as the space in which they feel the most comfortable. in addition, you can demonstrate leadership by putting yourself forward as a subject matter expert. we have many members who have established themselves as such by authoring articles for the amwa journal, presenting webinars, leading workshops, or presenting at chapter or annual conferences. members can also serve as subject matter experts for the education committee. by sharing your expertise, you are investing in yourself as well as our profession. of course, this wouldn’t be a proper president’s column without me mentioning this year’s medical writing & communication conference in baltimore. i’ve been getting sneak peeks into the content that will be offered at this year’s conference, and this year’s program promises to be amazing. our annual conference is where leaders and experts share their knowledge. this is the heart of amwa. come experience it this year in baltimore and be inspired. from the president expertise and leadership amwa news elise eller, phd / 2022–2023 amwa president http://www.amwajournal.org v38 n4 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 5 theme article abstract ethical publication practices apply universally, but differing cultural contexts can alter the interpretation and application of guidelines. in particular, collaborating with colleagues and authors in the asia-pacific region can sometimes be confusing and frustrating when attempting to align expectations between all parties involved in medical writing projects. engaging with colleagues in other regions to develop flexible, culturally appropriate processes can help strengthen working relationships, expedite project completion, and adhere to publication best practices. research into international differences in adhering to publication ethics guidelines has historically suggested that standards in the asia-pacific region (apac) are lagging behind those in north america and europe.1 however, recent data suggest that awareness and adherence to the principles of publication ethics is increasing in apac.2 in addition, there are a number of challenges regarding the application of international guidelines in apac, including limited engagement with regional representatives and relatively scarce resources to support regional research and guideline development.3 despite this, a number of organic efforts have been initiated within apac to better understand publication practices and to bridge differences in expectations between regions.1,4-9 this is similar to efforts made within apac to adapt international medical treatment guidelines to account for the specific circumstances in apac compared with other regions. the difficulty in aligning expectations across cultures independent guidelines developed to improve ethical publication practices and industry internal standard operating procedures that use these guidelines as a framework are often applied on the basis of regional differences not materially impacting their application. accordingly, many of the conventions surrounding how ethical publication practices and authorship are applied when developing english-language medical publications have been developed in predominantly english-speaking high-income countries.3 for example, every author is generally expected to openly share documents illustrating proposed changes and detailed comments with the authorship group and other stakeholders. debate is expected, and encouraged, to improve the quality of the publication, and the opinions of individuals are considered on an equal basis. in addition, although communication has traditionally been via formal written correspondence (eg, email), the convenience of video calls also means that real-time verbal discussions between authors are now common. some of these practices can be inconsistent with cultural expectations and norms in apac, so there is a risk that important clinical insights that could be offered by authors and other stakeholders may be missed if stakeholders are unable to fully articulate their ideas and/or feel hesitant to comment, especially speakers of english as a second language. likewise, alternative forms of communication that are prevalent in apac, whether they be verbal feedback provided one-on-one during in-person meetings or via messaging apps (eg, wechat), may not strictly align with standardized procedures for commenting or maintaining formal records that are applied in western countries.8 here, we describe the cultural and communication norms in apac and provide some recommendations on how these can be effectively navigated to ensure that important insights from all stakeholders are not overlooked. the current landscape most discussions regarding medical publications are conducted exclusively in english, which poses challenges for communicating complex ideas for those who do not speak english as a first language. furthermore, there is a growing expectation to engage in situations that can be challenging for non-native english speakers from apac, such as video conferences, in which it can be difficult to follow comments from numerous people who are often speaking quickly and with different accents. in particular, east asian cultures (eg, japan, china, korea) tend to favor consensus-seeking and collectivism over individualism. so, for example, although interruptions can be routine and tolerated in video conferences, jonathan lee, phd, cmpp1 and blair hesp, phd, nzdipbus, cmpp2 / 1takeda pharmaceuticals international ag– singapore branch, singapore; 2first in human, kainic medical communications ltd, dunedin, new zealand embracing cultural differences to ensure ethical publication practices http://www.amwajournal.org amwajournal.org 6embracing cultural differences to ensure ethical publication practices many participants from apac will default to agreeing with or approving statements from others to out of fear of embarrassing themselves or their colleagues and to avoid any potential conflict. likewise, there can be a tendency for people from some parts of apac to be careful to defer to more senior colleagues, especially in a public setting. unwritten cultural protocols regarding marks of respect and how to politely interact with colleagues in apac can also make it difficult for native english speakers to correctly interpret comments and remarks. unless you are very familiar with the person’s culture, this can be a source of substantial confusion and frustration when working with colleagues and authors from apac. effectively navigating language and cultural differences when engaging people in apac professionally, we recommend consulting with someone with substantial local knowledge before initiating a project. people with regional expertise are generally eager to help their peers navigate cultural sensitivities and may help you avoid potential pitfalls. the mere act of seeking guidance in advance is likely to be widely appreciated. allowing for extended review times and less formal methods of communication that the local team and authors are familiar and comfortable with, such as wechat in china, may be necessary. likewise, utilizing the support of a person who can speak an author’s native language or meet with them in person can improve the volume and quality of comments. one-on-one engagement, in person or via email, can also facilitate effective communication by offering circumstances for individuals to speak freely without fear of disrespecting colleagues. when communicating in a group setting, requests for feedback should be individualized before being communicated in a consolidated, anonymized fashion. novel challenges in 2023 the increasing prevalence of plain-language summaries and enhanced content offers new opportunities for engaging apac, but their limitations still need to be understood. for example, lancet global health invites authors to submit translations of the abstract of an accepted manuscript. however, most journals do not offer such broad multilingual opportunities, so most plain-language summaries need to comprise wording, imagery, and context that can survive translation across languages and cultures. intended messaging can be misinterpreted or literally lost in translation. artificial intelligence is also rapidly evolving, and as of mid-2023, its utility in medical writing has not yet been fully established. although likely offering two-way benefits for communicating across cultures and languages, the limitations of artificial intelligence in writing and translating need to be remembered. conclusion considering cultural and communication differences is important when working with authors outside of north america and europe. ensuring full access to the valuable insights of authors who are speakers of english as a second language, such as those from the apac region, can improve the quality of medical writing when approached in a culturally appropriate manner, ultimately benefiting the patients we strive to support through our publications. author declaration and disclosures: jonathan lee is an employee of takeda pharmaceuticals international ag– singapore branch, is a sponsor of clinical research performed in apac, holds takeda stock, and is also the current asia-pacific trustee on the international society of medical publication professionals (ismpp) board of trustees. blair hesp is the owner of a company offering medical communication services to pharmaceutical, medical device, and diagnostics industries and authors within apac, including publication planning consultancy and professional medical writing support, and is also a member of the ismpp asia-pacific collaborations outreach committee. the ideas presented are those of the authors and not intended to represent those of their employers or ismpp. author contact: blairh@kainicmedical.com references 1. hesp br, arai k, bose n, et al. applying the good publication practice 2022 guidelines in the asia-pacific region: a practical guide. curr med res opin. 2023;39(6):919-931. 2. lee j, carruthers a, chung h, crawford r, lee j, li x. familiarity and implementation of global publication guidelines in asiapacific (apac): a cross-sectional survey. curr med res opin. 2023;39(suppl 1):s21. doi:10.1080/03007995.2023.2194075 3. khan m, abimbola s, aloudat t, capobianco e, hawkes s, rahman-shepherd a. decolonising global health in 2021: a roadmap to move from rhetoric to reform. bmj glob health. 2021;6(3):e005604. 4. hesp br, arai k, chu mys, et al. a guide to applying the good publication practice 3 guidelines in the asia-pacific region. res integr peer rev. 2019;4(1):21. 5. carruthers a, chung h, crawford r, lee j, li x, lee j. author language and communication preferences for providing feedback on english-language publications in apac: a cross-sectional survey. curr med res opin. 2023;39(suppl 1):s10. doi:10.1080/030 07995.2023.2194075 6. jull a, walker n. trial registration and time to publication in a retrospective cohort of publicly funded randomised controlled trials in new zealand 1999-2017. bmj open. 2022;12(10):e065050. 7. singhal s, kalra bs. publication ethics: role and responsibility of authors. indian j gastroenterol. 2021;40(1):65-71. 8. zhang j, ge y, wang j, et al. challenges and growth opportunities: the landscape of chinese medical publication professionals in the global context: a questionnaire-based survey. curr med res opin. 2021;37(2):261-267. 9. yi n, nemery b, dierickx k. how do chinese universities address research integrity and misconduct? a review of university documents. dev world bioeth. 2019;19(2):64-75. http://www.amwajournal.org v38 n3 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 42 the golden apple award is given to an amwa member in recognition of their consistent and outstanding excellence in leading amwa workshops. this year’s golden apple recipient is hope lafferty, am, els. hope joined amwa in 2003 and has been leading workshops, roundtables, and hands-on intensives since 2009. she has taught 14 workshop sessions spanning 3 workshop curricula for amwa. participants in her workshops consistently give hope high ratings and excellent feedback. hope’s involvement in amwa is truly on a national scale. beyond her national conference workshop leadership, she’s served 2 terms as the annual conference workshop coordinator and participated in the education committee. she also has been a member of at least 5 chapters, and in chapters where she wasn’t a member, she has led workshops and talks at amwa chapter events. her dedication to learning, teaching, and growth is evident in her career path and contributions. hope received her certificate in medical writing and editing from the university of chicago—where she also received her master’s degree specializing in group psychotherapy and cognitive-behavioral therapy. she is a past president of the board of editors in the life sciences and has served on the editorial board of the last 2 iterations of the ama manual of style. hope is a faculty member of the medical writing certificate program at the university of california, san diego. the bulk of her medical communication work centers on the academic and research space—with 100% of the grants on which she worked receiving fundable scores. in 2015, hope made a career pivot by stepping out from behind the desk to teach communication skills, scientific writing, public speaking, and leadership. in 2016, she received her training certificate from the association for talent development. in 2020, hope completed the habit finder coaching program, which is the foundational work behind this year’s amwa medical writing & communication conference intensive, “how to think like a leader.” hope also holds instructor member status at the robert s. hartman institute, a nonprofit that focuses on value theory, which is the math and science behind the habit finder assessment and hope’s work as a coach. hope made another career pivot—from writer and coach to playwright and performer—which led her to enroll in the professional training program at the dell’arte international school of physical theatre at the age of 57. in 2019, hope qualified to join the dramatists guild of america, the lead professional organization for playwrights and lyricists, and is an individual member of the american association of community theatre. she is currently touring 2 solo shows across north america. please join amwa in congratulating hope as she receives her award this fall at the medical writing & communication conference in baltimore, md. the member awards recognition committee members were abbie miller, mwc (chair); loretta bohn, els (board of directors liaison); elizabeth brown, ms, pmp; joanne mcandrews, phd; christina barnes, msn, rn, cpnp-pc; jerm-day storms, phd, mwc; and susan aiello, dvm, els. diane noland served as staff liaison, and susan krug, ms, cae, served as ex officio. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: abbie.roth@nationwidechildrens.org 2023 golden apple award recipient hope lafferty, am, els amwa news abbie miller, mwc / 2022-2023 chair, member awards recognition committee http://www.amwajournal.org v37 n2 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 9 this interview describes how the good lay summary practice guidance (glsp) came into existence. its development had been initiated by a group of enthusiasts who wanted to provide guidance on how to plan, write, translate, and disseminate lay summaries and on how to best involve patients into the process. the glsp is the result of a multi-stakeholder initiative with more than 60 contributing organizations, comprising patients, patient organizations, academic research networks, small and medium enterprises, and members from big pharmaceutical companies. the initiative collaborated over more than 3 years to arrive at a final guideline that was then accepted into regulation. major steps were the development of an organizational structure consisting of a core management team and 5 task forces that worked on the different topics, a large global public consultation of the draft document, and an intense discussion with the regulators in europe. dr ingrid klingmann, a physician, patient advocate, and cancer survivor, was at the helm of the roadmap initiative during the entire time and provides her insights on the challenges and results of this long and successful process. dr ingrid klingmann is a physician, patient advocate, and cancer survivor. she has been at the helm of the multi-stakeholder good lay summary practice (glsp) initiative that developed a guidance for writing lay summaries. lay summaries are short documents understandable for the public that summarize the results of clinical trials. lay summaries are now mandated for all clinical trials in the european union (eu) based on european clinical trial regulation (536/2014). they are also called plain language trial summaries, patient summaries, or trial result summaries. lay summaries are a novelty as they are the first regulatory documents that are meant to inform the public. even more so, the glsp initiative was the first guidance that had been developed by a multi-stakeholder initiative that was then adopted as regulatory guidance. some readers may be at odds with the use of the word ‘lay’ as for them it has a belittling connotation. however, as this is the official legal term in europe, it has also been used in this article. interview schindler: why did you and the european forum for good clinical practice (efgcp) pick up the topic of lay summaries in 2018? at that time, several working groups had already been developing recommendations. klingmann: efgcp had already been involved in the preparation of certain aspects of the european clinical trial regulation. however, at that time there was no discussion on informing the public about the results of clinical trials. when the european regulation was released in 2014, we were surprised to see the obligation to prepare lay summaries for all clinical trials. apparently, this topic had been added very late to the legislation. the mandate to inform the public in a systematic way about the outcomes of clinical trials triggered a lot of interest and excitement, and efgcp and the european federation of pharmaceutical industries and associations (efpia) decided to organize a workshop. we wanted to clarify what it would mean for sponsors to prepare and disseminate lay summaries. during this first workshop in 2015, we became aware of the work of international collaborations such as multi-regional clinical trials (mrct) and transcelerate. it became clear that stakeholders would need more detailed guidance on the content and structure of lay summaries. when the european expert group issued their guidance on structure and content of lay summaries in 2017, we conducted another workshop thomas m. schindler, phd / boehringer-ingelheim pharma and lay & regulatory writing, biberach a.d. riss, germany the making of the good lay summary practice guidance: a multi-stakeholder document that was adopted into regulation – an interview with dr ingrid klingmann theme article http://www.amwajournal.org amwajournal.org 10the making of the good lay summary practice guidance during which we reviewed their guidance. we realized that it was not enough to know about the requirements and best approaches to present the content, but that an overall process for planning, preparation, translation, and dissemination was needed. most importantly, producing lay summaries should involve patients in a systematic way. this aspect had not been included in existing guidances at the time. we had a very strong patient representation at this workshop, and they made it very clear that without patients, the process cannot be successful. as a conclusion from that workshop, efgcp and efpia decided to create the “roadmap initiative to good lay summary practice” (the glsp initiative). schindler: what were the aims of the glsp initiative? klingmann: to bring together all the involved stakeholders—so, commercial and academic sponsors, patients, patient organizations, not-for-profit organizations, medical writers, lay language specialists, and translators. we wanted to involve all viewpoints and existing experience to jointly develop guidance on how to set up an overall lay summary process. we needed a bit of time to get our act together, but then our road map initiative was kicked off in 2019. schindler: what were the biggest challenges in getting the initiative off the ground and keeping it afloat? klingmann: well, there were a lot of challenges. firstly, we needed to give the initiative an organizational structure and we needed to identify the topics to work on. in total, we had over 60 organizations from europe and the united states who participated in the initiative. to more efficiently manage the process an international core management team was formed. initially, after a lot of discussion, we settled on 5 task forces, each one led by a member of the core management team and a patient or patient representative. the initial task forces were 1. principles and processes of lay summary implementation beyond existing guidance. 2. competencies required for development and translation of lay summaries. 3. lay summary dissemination within and beyond the european medicines agency (ema) portal. 4. the issues of lay summary creation, translation, dissemination, and funding, particularly for academia and small and medium enterprises. 5. suitable technology to reach patients, health care professionals, and the public including the development of lay summaries for trials in children. it was difficult to get people to actively contribute to these different task forces. participants were sometimes unaware that simply listening in was not going to help moving forward. the idea was to actively work out the content and to develop recommendations. ultimately, we managed through a process of regular meetings, regular updates, and building up awareness in all the task forces to adhere to the timelines and to come up with proposals. in spring 2020, we had brought together a first draft of the glsp that was then used in a very early discussion with the european commission. they indicated that they were principally interested in collaborating toward a guidance and expressed that working on this aspect of transparency would be a good way to support the overall goals of the new european clinical trial regulation. in line with the core management team, the commission supported the plan for a wide-spread public consultation on the draft in summer 2020. it was agreed to reconvene thereafter. glossary cteg – the commission expert group on clinical trials. they provide the commission with advice and expertise on clinical trials in relation to the preparation and implementation of legislation and policy initiatives. the cteg is part of the directorate sante and consists of delegates from all national authorities and ethics committees in europe. efgcp – the european forum for good clinical practice. they are a not-for-profit organization established by and for those with an interest in the development of medicines and medical technologies. efpia – the european federation of pharmaceutical industries and associations. they represent the biopharmaceutical industry operating in europe. european commission – the executive branch of the european union (eu). it operates as a cabinet government with 27 members (informally known as “commissioners”) headed by a president. european clinical trial regulation – the binding law that specifies the rules for conducting clinical trials throughout the eu. mrct – multi-regional clinical trials. they are a research and policy center that wants to identify and deliver ethical, actionable, and practical solutions for the global clinical trial enterprise. transcelerate biopharma – a not-for-profit entity with a mission to collaborate across the global biopharmaceutical development community to identify, design, and facilitate solutions designed to drive the delivery of new medicines. http://www.amwajournal.org amwajournal.org 11the making of the good lay summary practice guidance the glsp draft was posted on the efgcp website and disseminated by all roadmap members to their networks. we received a high number of comments on the structure and a lot of detailed recommendations from all stakeholders. and of course, like always, after such a public consultation, it takes time to consider and discuss and agree on the comments and write a revised draft. the workload associated with integrating the various comments and the preparation of a second draft was a major challenge for the initiative. in addition, much to our surprise, one of the key messages was that the document that we had produced was far too complex and too long (about 100 pages), especially for academic sponsors and investigators, and that we would need a type of summary. in response to this, the team developed the idea of having a “quick guide,” summarizing the principles and basic information, and a “handbook” that contained the detailed guidance, recommendations, and experiences. and with that we went again to the european commission. keeping all stakeholders invested during the difficult discussions that ensued was a major challenge. schindler: was it your idea to involve the european commission at the draft stages? klingmann: actually, it was an idea that was developed in the core management team during one of our regular meetings. the team thought that the most effective way to support the implementation of good lay summary practice was a guidance that was issued by the regulators, ie, the european commission. we believed that an official release and recognition would make it so much more powerful than when it was coming from a group of enthusiastic individuals who wanted to improve the world. schindler: in this long journey of the initiative, what were the moments of crisis? as a member of the core management team, i remember a few. there were instances when it was difficult to keep the academic group engaged, and there were moments of distress when some colleagues in major pharmaceutical companies wanted to have some very specific points included. most importantly, we had very critical discussions with the european commission and the clinical trial expert group (cteg). klingmann: well, in fact, you listed them already quite correctly. i think the involvement of academia was an ongoing issue that came in different waves. initially, it was difficult to get academia engaged at all because they were largely unaware of the new requirement. it became clear that the biggest issue for academia is that the writing of lay summaries is a very late-stage activity in a clinical trial. at that time, funding is often no longer available because conduct-related activities have subsided and given current funding procedures, writing a lay summary after the end of the project is not possible. unfortunately, this situation is not solved. so, we agreed that we would also need to work with the large funding bodies to make them aware of the situation. when we had submitted the revised draft glsp to the european commission, they forwarded it to the cteg for comments and review. because cteg is a group of 54 representatives from national regulatory authorities and ethics committees of all european member states, we were afraid of receiving many comments and maybe even serious pushback. and, as expected, we received a substantial number of comments and a list of several topics with which they were not in agreement. one problem was that they insisted that the glsp must primarily be a european document because it relates to the european clinical trial regulation. so, the need for lay summaries for patients in international and global studies and the need of patients all over the world to have access to these lay summaries was not a priority for them. it was quite a tough discussion, and it was difficult to find agreement. some representatives of global pharmaceutical companies were disappointed about this focus on the eu. however, building on the good will of all stakeholders, we were able to agree on a compromise. the second topic that the european commission absolutely did not want to go into was indirect dissemination— that is, dissemination of lay summaries via company or third-party websites. they felt that it was not appropriate to provide guidance in the glsp because currently there is no broadly agreed standard for this type of dissemination. also here, some representatives of large pharmaceutical companies were disappointed because they were hoping to get further guidance on how to disseminate lay summaries in a compliant way. in the core management team, we agreed to tackle this topic again and work it out in full detail for another discussion with the regulators. this discussion in spring 2021 was one of the most critical moments when it was really unclear whether we would come to an agreed document. schindler: you really contributed a lot to steer the initiative through these crises and you skillfully managed the interaction with the regulators—your professionalism was truly important for the success of the initiative. klingmann: well, many people contributed to this—not only me—and many members helped to overcome diffihttp://www.amwajournal.org amwajournal.org 12the making of the good lay summary practice guidance cult moments. in addition, the commission and cteg had appreciated that this was a multi-stakeholder initiative with strong patient involvement. they were willing to accept that they could have not created something better. whatever they would have done could only have been top down, and probably not as relevant and practical as the document that we have produced. finding agreement on the various topics of concern was often difficult, but many members of the initiative and the core management team contributed to a good outcome. remember, we had 9 months of intense interaction between all the road map stakeholders and the european commission to come to a final document. schindler: for me, one of the most fascinating things is that the glsp is a bottom-up multi-stakeholder initiative that made it into law. klingmann: yes, it is unique that an initiative that was started by a group of enthusiasts who wanted to provide clinical trial data in an understandable way was recognized by regulators and turned into an official guidance. the final document is posted on the eudralex website, which is the place where all european laws are published. i believe it was of critical importance that the initiative was driven by a neutral body, and i am proud that efgcp could serve in this capacity. another key factor was the ongoing substantial involvement of patients in the initiative. the role of patients was very practically worked out throughout the entire guideline without avoiding the complexities that this may create sometimes. so, it was not big pharma or academia who drove this guideline, but it was the balancing of all the efforts of the different stakeholder groups in an open and fair way. for academic research and for small and medium enterprises, it was important to be offered a stepwise approach of implementing the glsp. schindler: you have been at the helm of the initiative for more than 3 years. what does it take on a personal level to make such an initiative successful? klingmann: first of all and foremost, it takes a lot of time and energy. i was working philanthropically for the initiative, and i still had to do my other work. during the intense phases, i had only very few weekends for myself. it requires a lot of energy to keep people engaged, which is sometimes difficult to muster. from time to time, i needed to give myself another push to advance the topic and to motivate the others and encourage them to deliver on the agreed topics. and of course, i was not alone in this. we were so lucky to have an exceptional group of dedicated individuals in the core management team. without their ongoing support and their critical input over several years, the initiative would have gotten nowhere. also, i am very thankful for the ongoing support of all the members in the task forces and the entire initiative. i believe we have a window of opportunity now to make the provision of lay summaries a part of the normal clinical trials process. with the covid-19 crisis, there is so much interest in transparency and in the results of clinical studies. our initiative will make those results more readily available for patients and the public. schindler: what are the next steps for the glsp initiative? klingmann: most importantly we need to continue spreading the news about the availability of the glsp to all parties that are potentially involved in the preparation of lay summaries. webinars and workshops on a national level are planned. a next step could be to make the glsp available in additional languages. the initiative is currently planning training programs for stakeholders and members of the public to learn about best practices in the preparation of lay summaries. and we will create an independent glsp website that will become the central communication tool and repository for glsp–related activities and content. another key issue we need to tackle is to encourage academic researchers to fulfill the obligation of writing lay summaries, especially because about 40% of all trials in europe are conducted by academia. we need to continue the discussion with the european commission, particularly the directorate-general “research and innovation” that is providing funding for a lot of academic clinical research. in addition, we need to continue to inform national funding organizations about the requirement to write lay summaries and related resource needs. they need to change their requirements and their funding conditions to meet the costs associated with providing lay summaries. we want to re-initiate the discussion with the regulators on the topic of indirect dissemination, ie, the option of sponsors to make lay summaries available on their websites. although lay summaries are a european requirement, all patients in a global trial and the global public have the right to be informed about results regardless of their location. for this, we need to define the processes and develop an appropriate framework. and of course, the initiative should continue to provide a platform for best practices for example the provision of lay summaries for children. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: lay_and_regulatory_writing@gmx.de http://www.amwajournal.org amwajournal.org 13the making of the good lay summary practice guidance bios ingrid klingmann, md, phd, ffpm, fbcpm she is a physician specialized in clinical pharmacology with over 30 years of experience in different senior functions in the pharmaceutical industry focusing on clinical trial design, ethical, and regulatory aspects. she owns and manages a pharmaceutical development and site management support consulting company since january 2003 (pharmaplex bv). the company creates networks of experienced specialists that work on diverse international projects such as drug development consulting, study management for pharmaceutical companies, teaching projects, and academic site support. dr klingmann is chairwoman of the board of the efgcp. based on her broad professional background, she facilitates the alignment between stakeholders in medicine development with the aim to develop patient-relevant treatments more efficiently. dr klingmann is currently also secretary of the european federation of exploratory medicines and president of pharmatrain federation (eufemed), a not-for-profit organization focusing on global standardization and improvement of post-graduate training in medicine development. she teaches on topics like clinical research and regulatory affairs at the universities of bonn, basel, and the université libre de bruxelles. thomas m. schindler, phd he is a biologist and linguist educated in germany and the united kingdom, holds a phd in molecular physiology, and did postdoctoral research in the united kingdom. he was the editor of popular science books in biology, geography, and astronomy. he then turned to medical writing and has over 25 years of experience in both medical affairs and regulatory medical writing, including the preparation of marketing authorization application dossiers in different jurisdictions. he founded, established, and led the medical writing function at boehringer ingelheim for almost 20 years, and he has recently focused on lay summaries, video creation, and ai-driven writing. he participated in the transcelerate return of results work stream, is in the core management team of the glsp initiative and has supported the development of the patient-focussed medicine development (pfmd) plain language summary guidance. for many years, he is the editor of the statistics section, “statistically speaking,” of the amwa journal. a career in medical communication: steps to success learn about the skills and attributes needed to be a successful medical communicator and discover opportunities in the field. www.amwa.org/career_steps further reading directorate-general for health and food safety. good lay summary practice guidance. european commission; 2021. accessed february 21, 2022. https://ec.europa. eu/health/latest-updates/good-lay-summary-practiceguidance-2021-10-04_en european expert group. summaries of clinical trial results for laypersons: recommendations of the expert group. version 2. expert group on clinical trials; 2018. accessed february 21, 2022. https://ec.europa.eu/health/system/ files/2020-02/2017_01_26_summaries_of_ct_results_for_ laypersons_0.pdf aldinger c, bierer be, collyar d, li r, myers l. mrct center return of aggregate results to participants guidance document. version 3.1. multi-regional clinical trials center of brigham and women’s hospital and harvard; 2017. accessed february 21, 2022. https://mrctcenter.org/ wp-content/uploads/2017/12/2017-12-07-mrct-returnof-aggregate-results-guidance-document-3.1.pdf schindler tm. lay summaries of clinical study results. in: hall g, detora l, eds. regulatory writing: an overview, second edition. raps; 2020:265-277. brauburger k, sroka-saidi k, schindler tm. new european clinical trial regulation: the requirement for lay summaries and its impact on medical communicators. amer med writers assoc j. 2015;30(2):60-63. http://www.amwajournal.org https://ec.europa.eu/health/latest-updates/good-lay-summary-practice-guidance-2021-10-04_en https://ec.europa.eu/health/latest-updates/good-lay-summary-practice-guidance-2021-10-04_en https://ec.europa.eu/health/latest-updates/good-lay-summary-practice-guidance-2021-10-04_en https://ec.europa.eu/health/system/files/2020-02/2017_01_26_summaries_of_ct_results_for_laypersons_0.pdf https://ec.europa.eu/health/system/files/2020-02/2017_01_26_summaries_of_ct_results_for_laypersons_0.pdf https://ec.europa.eu/health/system/files/2020-02/2017_01_26_summaries_of_ct_results_for_laypersons_0.pdf https://mrctcenter.org/wp-content/uploads/2017/12/2017-12-07-mrct-return-of-aggregate-results-guidance-document-3.1.pdf https://mrctcenter.org/wp-content/uploads/2017/12/2017-12-07-mrct-return-of-aggregate-results-guidance-document-3.1.pdf https://mrctcenter.org/wp-content/uploads/2017/12/2017-12-07-mrct-return-of-aggregate-results-guidance-document-3.1.pdf v38 n1 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 12 the walter c. alvarez award is named in honor of walter c. alvarez, md, a pioneer in the field of medical communication. the award is presented to either a member or nonmember of the american medical writers association (amwa) to honor excellence in communicating health care developments and concepts to the public. the alvarez award is presented during amwa’s medical writing & communication conference. hello everyone, it’s a pleasure to be with all of you. and as i start, i want to first of all acknowledge the people who’ve made this amwa conference possible and the annual conference chair, dr kimberly korwek. i’d also like to thank the amwa executive director, susan krug, and all of you at the american medical writers association. all of you at amwa have also been on the frontlines in this confusing and frightening time. we are working with incomplete information, interpreting new science, helping people with news that they need to use in their daily lives to navigate huge uncertainty and protect themselves and their families, and to understand changing policy implications that often are changing by the minute. all of you are on the frontlines, not just with covid, but also with all other aspects of health and wellness. your work is so important, and i want to thank you for what you are doing every day. i’m also delighted to join virtually another award winner, my colleague, dr peter hotez, who as you know, is being honored for his exceptional work in medical communication and is a superb clinician and researcher, and who, along with his colleagues, has developed a covid-19 vaccine. so, what great company we are all in. well, in my presentation today, i would like to talk about communicating public health in times of conflict and controversy, and my discussion is going to be in 2 parts. first, i want to talk about what we have learned from covid-19, touching on the role of journalists, medical writers, and communicators, and then i want to discuss what we can do moving forward. and for each of these 2 categories, i want to give 3 lessons and move from less controversial to more controversial. and i look forward to engaging with all of you during this event and going forward as well. so, first category of what we have learned from covid, 3 things. the first—and again going from the more obvious, less controversial to perhaps more controversial—the first is that there are many neglected issues that have been bared for everyone to see. not a surprise to any of us who work in health, but i think these may be some issues that much of the american public may not have had as much awareness of—for example, health disparities. disparities did not start with covid, but covid certainly amplified them. we saw this early on in terms of who has the ability—the privilege of social distancing, and who does not. we also saw this in the way that vaccine distribution first occurred, and when something was in extremely short supply like covid vaccines, it was those who were able to get their smartphones and have all their friends and family start finding vaccine appointments who were able to get them first. now, we also see those disparities don’t go away on their own, and we’re now seeing many of these same disparities playing out in monkeypox. we’re seeing the same disparities playing out in virtually every other health issue that we can think of. but that, i think, is a neglected issue that more people are seeing now more than ever. 2022 walter c. alvarez award address emerging issues following covid-19: public health communication leana wen, md, msc, faaem / george washington university, washington, dc conference http://www.amwajournal.org amwajournal.org 13emerging issues following covid-19: public health communication similarly, with the concept of social determinants of health. now again, all of us working in health and in health care know that you can’t separate someone’s health outcomes from the housing that they have access to, from the food that they have access to, or from working conditions, but i think those issues also really played out during covid in a way that shed awareness for the first time for many individuals. one more issue, too, is that this country is really lacking in public health infrastructure, and one could even argue that we don’t have any kind of functional public health infrastructure. it was mentioned that i ran baltimore’s health department. and i saw for myself every day how it was all about robbing peter to pay paul, that already— those of you who have a public health system for local and state health departments across the country know what i’m talking about here—people are already wearing multiple hats. the same people working on school health are also being pulled to staff shelters for individuals experiencing homelessness in the winter. and then you have something like covid come along, and those same people are being moved from school health to now working on setting up vaccine clinics or setting up testing. and then now there’s monkeypox, or now there’s the reemergence of polio, and now these people are being pulled off these other crucial priorities to emerging issues, too. and i think this has been another issue bared for everyone to see, that there is no face of public health. now, by definition, public health works when we are invisible. but the problem when we’re invisible is that public health becomes the first thing on the chopping block when it comes to budget time, and as a result, we’re seeing the consequences of neglecting public health throughout. well, i just hope that we have learned from all of this that the cost of doing nothing isn’t nothing. just something that my former mentor, the late congressman elijah cummings, used to say, “the cost of doing nothing isn’t nothing.” now, when we neglect public health, there are severe consequences, some of which we have seen during covid. the second lesson that i believe we’ve learned from covid is that public health depends on public trust, and when that’s eroded it’s very difficult to get back. when i look back at the very beginning of the pandemic—i think in retrospect with 20/20 hindsight—things could have been done differently. and actually, probably the top thing that i wish that i and others had done a better job of communicating early on and throughout is that change is to be expected. actually, change is the bedrock of sound public health policy when you’re in the middle of an ever-changing situation like a new virus and a new pandemic. now, when you look at many of the arguments against vaccines or various covid protocols, it’s that public health officials are accused of being flip-flopping, but it’s not flip-flopping when circumstances change. in the beginning, as you all remember, we didn’t know that covid was airborne. we were really worried about surfaces, and we were advising people to wipe down groceries. there were no recommendations for masking early on because we just didn’t know about transmission, and then we recommended masks. but then, it looks like flip flopping even though it was that the science evolved, and also that circumstances changed. similarly, when vaccines first came about, we believed that in addition to preventing severe illness, they also prevented infection. well, that changed with evolving time, with the arrival of the omicron subvariants that the vaccines were less protective against infection during omicron spread. and so, there is less a case for mandates than there were before, and so recommendations have to change with those growing circumstances with those changing circumstances in mind. and that’s actually something that in clinical medicine is really apparent because, in clinical medicine, you would absolutely expect that if you’re treating a patient with cancer, as an example, and there’s a new chemotherapy regimen that comes out, you would absolutely expect that your clinician is going to be offering that new regimen. you want your doctor to stay up to date with the science. and also, changing circumstances matter too. using the same analogy, if someone’s body is responding one way to one treatment and not responding as well as it should maybe to another, you would expect those recommendations to evolve. well, that should really be the case when it comes to public health policy as well. and again, looking back, one thing that i wish we had done a better job of is to communicate that change is the bedrock of good public health policy. and i think by communicating the change, communicating not just what changed but why, over and over again, i think that is going to be crucial to reestablishing trust. the third lesson that i believe that we’ve learned from covid is that public health has become very polarized. now, my great concern prior to covid was that people were not thinking about public health. now, we had to make the case for why public health matters to public safety, or why it matters to education, and why it matters to the economy. but it was a fairly neutral topic—it just wasn’t something that people really thought about. and a major concern, having run a local health department, was that public health was always underfunded. well, i have a different concern now, and i think it’s an even more significant concern. let me take you back to a http://www.amwajournal.org amwajournal.org 14emerging issues following covid-19: public health communication focus group that i had the opportunity to participate in for the bulwark, and we did a podcast based on this. but the focus group was looking at the various mitigation measures, and they were interviewing republicans, democrats, and independents, and what really came through in the focus groups was that masks and vaccines means something other than what they are, which are public health measures that help to reduce virus transmission. for one group, and you can guess which group, but for the group that’s antithese measures, they see masks and vaccines as being about control, about government control over individuals. this was a fight for individual liberty, versus for the other group that very much wanted masks and vaccines—one would argue perhaps even want mask mandates and vaccine mandates still. for the other group, it was almost a reaction to that first group, and masks and vaccines equaled caring for others and equaled not being part of that antimask, antivaccine “republican” group. and so, i bring this up because i really worry about this. i mean, public health has always been hard because it’s about balancing individual liberty versus what’s best for all and protecting the most vulnerable. it’s not clear where that pendulum is going to be, someone is always going to be accusing you no matter what policy you set of having the balance wrong. you’re either weighing more toward individual liberty or more toward doing something that protects all but at the cost of individual liberty, and that’s not an easy balance to strike. i mean, even thinking about something as basic as whether somebody with multidrug-resistant tuberculosis should be required to quarantine or be required to isolate for the duration of their illness. i mean, even something like that that i think for most of us in public health would be pretty easy to say, “yes, that person should be in isolation.” but enforcing that, especially against that person’s will, that’s still a matter of saying what’s best for people—for all people, is going to outweigh individual liberty. so that balance has always been hard to strike. but i would say now that balance is many times harder to strike because we are now seeing a substantial backlash against public health in a way that we have not before. we have more than half of states passing laws and legislatures passing laws that restrict public health authorities in some way. that’s not just going to affect covid, but many other issues down the line. for example, if there is a bill that prevents local health authorities from issuing mask mandates in the future, a patient with multidrug-resistant tuberculosis, or somebody with measles, which is a most contagious illness—things like that will also be affected as well. we know that routine childhood immunizations are falling, and that’s something that’s also very concerning. we’re seeing that immunizations that previously were just accepted as something that children should do, was an optout. now a lot of parents are beginning to question whether certain immunizations should go forward or not. and i have this very significant concern that the backlash against covid restrictions, because of how politicized covid has become, is now bleeding into these other things, and there are really significant consequences here. we’re talking about infectious diseases, but we’re also talking about other aspects of public health. again, if public trust is eroded, it’s very difficult to get back. and i’m very concerned that we’re going to lose trust from the public for the next virus that could be a pandemic, or we could even lose trust from the public for other routine public health matters that previously were not questioned. now, it’s unfortunate that many public health officials and experts during covid have been attacked for our views. dr hotez is certainly one who’s come, unfortunately, under attack. i have had similar experiences, and i would just say that from my standpoint, i think there is a reflex— sometimes blame, if you will—of saying, “well, it’s one side. it’s the antimaskers or the antivaxxers who are attacking us for our views.” but i actually think that these attacks come from all sides. and again, this backlash i really fear is going to hurt what public health is able to do in the future. and so, here’s the controversial statement that i’m going to state and leave us on before we move to the second part of this conversation. and the controversial statement that i have is that the more we keep focusing on covid, the more it’s going to bleed into and have consequences on other aspects of public health. and i actually believe that when restoring trust in public health, we have to recognize that good health is not just the absence of covid, and we have to recognize that, like it or not, covid has been inserted in the middle of culture wars. and that if we are going to have any chance of depoliticizing public health and bringing public health back to this nonpartisan state that it should be in, i believe that we need to put the focus away from covid and more on other health issues that also very much impact health and well-being but are not subject to that same polarization as unfortunately, covid-19 has been. i now want to move to the second part of this discussion, which is “what can we do moving forward as medical communicators, as journalists, and as people who are public-facing?” and here, i have 3 recommendations, and http://www.amwajournal.org amwajournal.org 15emerging issues following covid-19: public health communication they’re going to move again from more obvious and less controversial to perhaps a bit more controversial. so, 3 things on how we can propel the conversation forward. the first is that we need to be transparent and intellectually honest with the public. let me explain to you what i mean here by giving you an example of something that happened at a conference several months ago. i went to a conference that was a lay audience conference, was talking about covid, and at that time just doing an explainer on boosters, vaccines, and immunity. and at the end of the conference, 3 people came up to me and almost whispered a question, and it was said to me as well, basically, “i didn’t want to raise this issue in this forum in front of everyone, but i want to ask you about natural immunity—is that a thing?” of course, it is a thing. i mean, it is true that there is such a thing as “natural immunity,” also referred to as immunity after recovering from covid or from other infections. i think what’s happened, and the reason why these very well-educated individuals who are very much pro-vaccine were afraid to ask the question, was that they feared a backlash. they feared a public response of other people in that audience accusing them of being antivax for asking the question about whether natural immunity exists. but you know what? it does exist, and i think if we are not honest about it with individuals. because look, i understand all the reasons at the beginning of the pandemic—i think especially right after vaccines first came out—i think there was this fear that if you talked about immunity after recovering, that people are not going to want to get vaccinated. but the thing is, you can say 2 things are true are once. it is true that you have some level of immune protection after getting infected. it is also true that you could get even better, more robust, and more lasting protection if, in addition to recovery from infection, you also got vaccinated. and, in fact, we have many studies now showing that this hybrid immunity conveys probably the most durable, the most consistent, and the strongest level of response. but acknowledging natural immunity isn’t being antivax, and actually, not acknowledging it makes people think that you’re hiding something from them and that you’re not being intellectually honest. and so, i think part of this is what we can do, i believe, as medical communicators are really being honest even when that topic is nuanced and difficult. now, we talked a little bit about masks earlier. i think that one of the reasons why the world health organization and the centers for disease control and prevention were not recommending masks early in the pandemic, very early in the pandemic, was that there was a very limited number of masks, especially n95 and new prevalent masks. and i think that we should have been honest and said masks could be helpful. we’re not sure because at that point in the pandemic— we’re talking march of 2020—we didn’t know exactly how helpful they were, but we could have said, “they probably are helpful, but right now we need to save them for health care workers.” i think that that type of intellectual honesty would have also avoided some of the accusations against flip-flopping later. similarly, with monkeypox vaccines, i think we should have been honest to say that they need to be rationed when there’s a limited supply and a lot more people interested in getting the vaccines than the supply initially was for. i know that rationing is a bad word, but it’s also the truth that at that time rationing had to occur. i think sometimes in communication in general, there is a need to try to simplify for our audience—and look, i’m not saying that this is easy at all. but i also think that our audience deserves the truth from us, and the truth is that science isn’t always clear-cut, and that medicine exists in the area of gray. two things—or multiple things—can be true at once. for example, mitigation measures can and do reduce the spread of the virus, but they all come at a cost. telling people, for example, to not gather with one another, having physical distancing, even mask-wearing—yes, they reduce spread, but they also have a cost. and so, i think those people who are trying to again get people to do something that they don’t want to do and follow mitigation measures sometimes feel like, well, we have to emphasize only the benefit. but then, i think we’re not being intellectually honest if we don’t also talk about the cost. and i believe that our duty, as communicators, has to be to give the full truth, not just the truth that we think others can handle. because if we do that, if we try to limit the truth and censor those who are trying to tell a fuller story, then  and i believe that our duty, as communicators, has to be to give the full truth, not just the truth that we think others can handle. because if we do that, if we try to limit the truth and censor those who are trying to tell a fuller story, then i believe we’re actually undercutting public health further and eroding trust further. http://www.amwajournal.org amwajournal.org 16emerging issues following covid-19: public health communication i believe we’re actually undercutting public health further and eroding trust further. the second thing, and again, 3 things here on things that we can do differently. the first is to be transparent and intellectually honest. the second is to acknowledge that following science is not a sufficient motto—that public health is, of course, based on the science, but ultimately, it’s about values. there’s been a lot of discussions now as we are moving through the emergency phase of covid-19 about when mitigation measures end, and that is in some ways based on the acceptable number of infections, acceptable number of hospitalizations, and acceptable number of deaths. some people might say that as long as hospitals are not getting overwhelmed again, then mitigation measures can end. others will say that as long as infection levels are high, as long as there is long covid, then we need to keep up mitigation measures. i mean, these questions are based on the science because modeling, for example, can help us to understand where we’re at and where we’re going. but this is not just a scientific question, this is a question just as much societal value. i think it’s important for us to again be intellectually honest about that. we also, crucially in public health, have to consider where the public is at. there is no point in recommending something if people literally won’t follow it. my sister’s partner is dutch, and we were recently having a conversation about how in the netherlands bike helmets are not required, and very few people are actually wearing bike helmets. and for us, in this country, it seems rather shocking that you have all these people biking but with no helmets. and the point that my sister’s partner was raising is, well, let’s say that you actually are now saying that helmets are going to be required, but if half or more of the population literally are not using helmets, it’s going to be impossible to enforce. and then if people start questioning this law or this regulation, you may have the issue of the boy who cried wolf. if they don’t trust you on this, and this thing cannot be enforced, then why trust you on other issues? and i think that’s been one of my considerations in thinking through when our mitigation measures need to end. it’s a values question, but the value also has to take into consideration where people are already. if most people are already not wearing masks, if most people have already returned to going to indoor restaurants and going to travel, it’s not going to work to say, “oh no, don’t do those things.” rather, we need to work on, in a sense, harm reduction. we need to help people to do the things that they want to do and make it safe for other individuals who are more vulnerable, so doing things like recommending same-day testing for individuals before they go see their elderly relative in a nursing home or making sure that people have access to vaccines and boosters. and that we’re also making treatments readily available and reducing all barriers to treatments and making sure that there are lots of other treatments that are actually hugely underutilized like evusheld, the preventive antibody—for example, it was hugely underutilized. how can we make sure that those things are pretty low-hanging fruit? i mean, these are not things that there is a societal objection against, but they are things that as a policy matter, we can try to make them more available. and i think that that’s one way of considering where the public is at and knowing that you’re not going to force people to do something that they don’t want to do. but you can still work around where people are to get to the point that we all need to get to, which is protecting the most vulnerable. this is another call for understanding and accepting the nuance that circumstances have changed. and i think part of this nuance is accepting that just because most individuals have returned to normal doesn’t mean that some individuals haven’t, and it also doesn’t mean that societal change has to stop. sometimes, especially when you look at social media, it seems like there are people who want to simplify and say, “well, if you are in favor of people returning to normal, that means that you don’t acknowledge that covid is real, or you don’t acknowledge the more than a million deaths from covid, or that you don’t acknowledge the toll of long covid.” i think both of those things can be true at once: i think it can both be true that covid has had this huge, terrible societal impact and continues to have an impact, and we need to address societal policy issues like improved ventilation, and paid sick leave, and aiming for universal access to health care. you can aim for societal change, but at the same time also acknowledge that omicron covid is going to be with us for the foreseeable future, and that we need to emphasize returning to normal in order to get people to see that good health is not just the absence of covid—both of those things can be true at once. and i think we as communicators should really push back against those who seek to simplify and further polarize where we’re at in this discussion. and so, that makes me move to the third thing. after being intellectually honest and talking about values, we need to embrace our role to seek the hard truths and to act with fairness and empathy. all of you as communicators and journalists, you are finding these neglected issues that http://www.amwajournal.org amwajournal.org 17emerging issues following covid-19: public health communication we begin our conversations with. you are the ones who are finding out about health disparities, and you know that if you don’t dig around for those data often, they’re not being produced. and so, i want to commend you for what you’re doing in this sense to really shed light on disparities, on social determinants, and on these other neglected issues. you also have such a crucial role to play as a communicator in accountability. how is the funding that’s being allocated being spent? there was funding going to classrooms for improving ventilation, and all this money going to local health departments. well, where is that money and how is it being spent? you are also the ones helping to make the connections on these various issues related to social determinants of health, and i think that your role here is so important. we started this conversation, too, by talking about conflict and controversy. well, i want to put another plug in for how a lot of that conflict and controversy is manufactured. often, it’s someone taking one sentence out of context, and that they want to make you, or me, or all of us about one or the other. and i think that our role as communicators also has to be honest and fair and to really point out when something is being taken out of context. i believe, too, that we have a role to be decent to one another, and when we fight among each other there is a potential harm that it erodes trust for all of us. and frankly, there are so many more issues that we must address together. we have the reemergence of polio, we have routine childhood immunizations falling off a cliff, and we have the opioid epidemic driven by fentanyl that’s gotten worse now more than ever. we have women’s health at a crossroads that’s being threatened across the country, and we have mental health that’s long been neglected and getting worse at this time. and, of course, we have this issue of robbing peter to pay paul and not having sustainable infrastructure for public health. there are so many issues that we need to address together. and i hope that coming out of covid, we’re able to come together and address these other issues, digging up data where needed, and holding people accountable where needed, but also trying to take away that level of anger from the conflict and controversy. we’re trying to depoliticize public health and getting us all back to the place where we’re able to work together on these difficult issues. now, the work ahead, no doubt, is very challenging. i want to end with a quote and an appreciation for all of us who work in public health and communication. and this quote is by dr harrison spencer, a former leader in public health—as you will see from this quote. and dr spencer says that “public health is filled with heroes, both wellknown and unknown. they are visible on the national or international stage, or they work quietly in communities with families and individuals. when they do their job, they often become invisible.” well, i believe that that is the job that you all do in amwa every day—you help to make the invisible visible, and you help people to navigate their lives at very challenging junctures. and you’re also helping us to push forward to a time where we’re able to really value public health as the crucial aspect of our overall national security and our well-being, and you’re helping to lay bare all these crucial issues that many people unfortunately are neglecting. and i truly believe that when the long arc of history is written, you will be the heroes, and i am so honored to join you at amwa today. thank you. acknowledgment i thank kavita garg, director of medical writing at saliegral global, for her help in bringing the transcript to the page. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: drwenmedia@gmail.com author biography leana s. wen, md, msc, faaem, is an emergency physician, public health professor at george washington university, and nonresident senior fellow at the brookings institution. she is a contributing op-ed columnist for the washington post, anchoring the weekly post newsletter “the checkup with dr. wen.” she is also an on-air medical analyst for cnn. http://www.amwajournal.org v37 n4 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 23 of all the points in the evolution of the medical writing profession, i believe we are at the pinnacle of what promises to be the most exciting and biggest paradigm shift in medical writers’ roles and responsibilities. with an accompanying leap in the introduction and use of technology in ways we have only dreamt of until now, this is a huge opportunity for all of us. however, it will also require medical writers to expand and hone their already extensive skill sets, and for their managers to embrace new technology and empower their teams to really grow and flourish into their new roles. for those forward-thinking companies, the rewards— including increased job satisfaction, faster and more effective submissions and approvals, increased general public engagement, and productivity from their teams—promise to be significant. globalization of medical writing collaboration among professional organizations collaboration and harmonization have to be the key aims and the buzz words for this next phase of medical writing evolution. each region doing slightly different things in slightly different ways is not only inefficient, but ripe for increased human error. there is an increasing demand for more and better medicines and information delivered more quickly to patients and the general public, and, coupled with a lack of highly trained medical writing professionals, the only way to meet this demand is to collaborate and harmonize as much as possible. this plea extends not only for collaboration and harmonization among professional organizations, but among regulatory agencies. let’s take one document—the clinical study report (csr)—as an example: imagine a utopian situation in which all csrs were written and data were presented in the same way. not only would these documents be much easier and quicker to produce and review, but much of the first draft at least could be automated, freeing medical writers to focus on their higher value skills of discussing key messages and key data points with their clinical and regulatory teams, and honing and crafting the final documents to be the concise and accurate representations of data that currently can take months to prepare (see comments on the shared technology question). harmonization of document templates and guidelines could also positively impact the dearth of skilled medical writers. not only could they leverage their knowledge and experience more easily between regions, but it would open up more career opportunities for them geographically, making the profession more attractive and increasing retention of talent. defining the profession along agreed lines with collaboration and harmonization across the industry come the added benefits of common training and educational aims and needs. this would allow certification systems to be put into place with meaningful outcomes and measurements and allow and encourage medical writers to expand their skill sets to meet the growing demands of the profession without relying solely on an individual company’s commitment to and expertise in their training. expansion to other professional associations/ professions with venn diagram overlap of course, the benefits of harmonization extend beyond the medical writing sphere. there are many areas of overlap with organizations such as scope, the international committee of medical journal editors, transcelerate, and the patient information forum. if the medical writing community can engage and collaborate more with these organizations, we can pool resources and knowledge and make a much larger impact on the guidelines and templates and information available to the general public. such organizations could also potentially contribute to aspects of any certification schemes for medical writing, bringing their specialist knowledge of their areas and offering specialist training opportunities. this can only benefit medical writers and the profession as a whole. shared technology there is no doubt that the industry is ripe for an explosion lisa chamberlain james, phd / senior partner, trilogy writing & consulting, cambridge, england the future of medical writing: a panel of one theme article http://www.amwajournal.org amwajournal.org 24the future of medical writing: a panel of one of shared and new technology, including etemplates, virtual and real time clinical trials, etc. transcelerate has already made huge strides in producing and making freely available some excellent templates for medical writers to use, which will hopefully encourage harmonization of documents across the industry. beyond that, software and technological advances are already taking shape, and regulatory agencies are preparing themselves (the united kingdom has proposed a new pro-innovation framework1 for regulating artificial intelligence). some initial offerings have been in place for several years now, and these are being expanded with new technologies to automate initial drafts, bringing the benefits and advantages already mentioned. common lexicons the general public are increasingly demanding more understandable and better information about their medicines and therapies. this is essential not only to engage the public in clinical development, but to help them better use their medicines. if we are truly to ask the general public to be involved in the decision making about their treatment or involvement in trials or in any stage of clinical development, we must clearly explain the benefits and potential harms, along with the context surrounding the need for the treatment, therapy, or intervention. however, it is an extremely difficult and highly skilled task to convert complex clinical and medical information into plain language. the first step is to find suitable vocabulary! excellent and ground-breaking work has already been done by organizations such as the clinical data interchange standards consortium and the multi-regional clinical trials plain language glossary group. a common lexicon is essential to be able to communicate with the general public to reduce the confusion created when different wording is used to explain the same disease or procedure. sharing the lexicons and making them freely available is a huge service not only to the medical writing profession but to the general public as a whole, and the continuation and expansion of these initiatives will allow medical writers to connect with audiences that have been out of reach for them until now. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: lisa@trilogywriting.com reference 1. mulryne j, schildkraut pj. uk proposes new pro-innovation framework for regulating ai. arnold & porter website. published july 26, 2022. accessed october 14, 2022. https:// www.arnoldporter.com/en/perspectives/blogs/enforcementedge/2022/07/uk-proposes-framework-for-regulating-ai biosummary lisa chamberlain james, phd, is a senior partner and ceo of trilogy writing & consulting. aside from management activities, she leads client projects with extensive experience in a variety of documents. lisa has a special interest in writing for the public and in patient information. following a phd and post doctorate in pathology at cambridge, lisa began her medical writing career in 2000. since then, she has been involved in emwa as a member of the educational committee, as a mentor, leader, and assessor of workshops, and teaches and reviews workshops for amwa. lisa holds an emwa professional development certificate, is a member of topra, dia, and pipa, initiated and chaired the emwa pharmacovigilance and communicating with the public special interest groups, and is also chair of the geoff hall scholarship committee, section editor of the “medical communications and writing for the public” section of medical writing, and a fellow of the royal society of medicine. http://www.amwajournal.org https://www.arnoldporter.com/en/perspectives/blogs/enforcement-edge/2022/07/uk-proposes-framework-for-regulating-ai https://www.arnoldporter.com/en/perspectives/blogs/enforcement-edge/2022/07/uk-proposes-framework-for-regulating-ai https://www.arnoldporter.com/en/perspectives/blogs/enforcement-edge/2022/07/uk-proposes-framework-for-regulating-ai v38 n1 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 40 common grantsmanship hurdles of early career clinician-scientists and how a medical writer can help abstract researchers with medical training and clinical experience bring essential perspectives to academic medicine. compared with their nonclinician, phd-trained peers, clinician-scientists typically have less training in grant writing, and their time for this work is even more constrained. medical writers can help clinician-scientists understand and fulfill the expectations of funding organizations and review panels, and ultimately, help them compete more successfully for funding. based on the literature and personal experience in this role, i propose 4 grantsmanship hurdles that often confront clinician-scientists: (1) identifying funding opportunities that fit, (2) mastering the unique language and integrated narrative style of a compelling grant proposal, (3) turning ancillary documents from drudgery into assets, and (4) shedding the “bunker mentality.” this article surveys practical strategies by which medical writers can foster time efficiency, mitigate experience gaps, and help clinician-scientists develop persuasive grant proposals effectively tailored to the relevant audience. medically-trained faculty at academic medical centers play essential roles in the advancement of biomedical research. clinician-scientists bring the perspective to recognize knowledge gaps that impede progress in patient care and translation of discoveries to the clinic. although they are well-positioned to enroll patients and coordinate clinical trials, early career clinician-scientists often receive minimal training in crucial research and grant writing skills and have heavy clinical duties that dominate their time. although junior faculty can seek didactic research training, it is often more effective and efficient for them to consult a medical writer with expertise in writing and grantsmanship. some academic institutions employ such consultants under job titles such as grant writer, scientific editor, or medical writer.1 an individual investigator might engage a freelance writer for similar support. this article discusses several grant writing hurdles facing clinician-scientists and details tools and strategies by which a medical writer can help them clear the hurdles and gain professional skills. clinician-scientists clinician-scientists are biomedical researchers who have formal training and credentials in a clinical discipline. although many clinician-scientists are physicians, the category also includes pharmacists, nurses, advanced practice providers, dentists, dietitians, and other medical professionals. clinician-scientists are sometimes categorized by how much of their professional effort is spent in clinical practice compared with research.2 the diverse backgrounds, job descriptions, and goals of clinician-scientists correspond with diverse funding objectives. those with a primary focus on research usually pursue federal funding along a prototypical path that aims for mentored career development grants (eg, national institutes of health [nih] k awards), then research project grants large enough to support a research laboratory or larger clinical trials (eg, nih r or u awards).3 others see themselves as clinicians first and have a complementary research portfolio that can be integrated with their clinical practice.2,4,5 critical funding for these individuals may come from subcontracts on federal grants, industry sponsorship of multisite clinical studies, or small grants from foundations, professional societies, or intramural funds. regardless of career trajectory, early career clinician-scientists face 2 particularly difficult headwinds. first, clinicians who assume junior faculty positions often start with limited research mentorship and hands-on research experience.5-7 in the sphere of grant writing, they may be unfamiliar with the structures, norms, and vocabulary that more experienced researchers take for granted. a clinician developing a grant might need guidance on how the review process works so that they can write with the true audience in mind. second, clinical duties increasingly dominate their time,4 so clinicians with thriving research programs often rely on a cast of trusted collaborators and team members working around them. a medical writer with expertise in grant writing who fosters effective communication and matthew r. sandbulte, phd / child health research institute at children’s hospital & medical center and the university of nebraska medical center, omaha, ne topical feature http://www.amwajournal.org amwajournal.org 41grantsmanship hurdles of early career clinician-scientists and how a medical writer can help efficiency is an invaluable addition to these teams and can help clinician-scientists capitalize on scarce research time. grantsmanship hurdles for clinicianscientists most grant writing challenges common among early career clinician-scientists are also familiar obstacles for their phd-trained peers, so the advice offered here might help a researcher in either category. however, training gaps and patient care duties for clinician-scientists often accentuate the following hurdles. by helping them clear these hurdles, medical writers can foster both professional achievement and progress in medicine. hurdle 1: identifying funding opportunities that fit funding agencies post funding opportunity announcements (foas) using a variety of channels, and the window of time between the foa and submission deadline can be as short as several weeks. investigators who passively wait for relevant opportunities to present are prone to discovering them too late or not at all. medical writers can assist by designing a robust search strategy, of the sources below and others, and perhaps even take responsibility for maintaining the search and alerting their clinician-scientist colleague(s) to possible matches. federal funding agencies foas for federal grants are relatively easy to track because sponsors disseminate them through well-maintained web resources. the comprehensive database at grants.gov is populated with links to foas from nih, the centers for disease control and prevention, other arms of the department of health and human services (hhs), the department of defense, and other agencies with missions extending widely across medicine and beyond. search filters allow users to focus on chosen agencies, funding categories, dates, and other variables. nihand hhs-sponsored opportunities also appear in the dedicated nih database at nih.gov, which features more agency-specific search and filter functionality; for example, you can filter results by activity code (eg, k08, r01) or by institute. in either of these databases, the save search function allows the user to set up automated email alerts about relevant foas in the future. private funding agencies societies and foundations represent the spectrum of clinical disciplines, medical conditions, and patient advocacy themes, and they issue a vast range of foas. although many of these foas are relevant to clinician-scientists, their configuration and dissemination vary widely. some private grant programs are offered on a regular annual or semiannual cycle, but in many cases the timing is unpredictable or a specific foa happens only once. because these foas are invariably posted on the respective organization’s website, clinician-scientists or a medical writer could proactively monitor the websites of relevant organizations for new foas. a few such organizations simplify this task by offering an electronic mailing list. however, neither method is very efficient if an investigator needs to monitor multiple organizations, or if a medical writer is assisting multiple investigators at once. one-stop solutions clinician-scientists and their grant writing consultants who are interested in diverse funding sources should consider accessing a subscription-based, comprehensive grants database (table 1). these continually capture new opportunities from thousands of private funding organizations, federal and state government agencies, and international entities. search filters and periodic email alerts make it possible to track opportunities in any sector that match an investigator’s research interests and project parameters (eg, submission deadline, budget size, geographic focus). investigators or consultants can begin by checking what access they may already have through institutional subscriptions. individual subscriptions to some of these services are also available. hurdle 2: mastering the unique language and integrated narrative style of a compelling grant proposal clinician-scientists tend to be goal driven and action oriented. in the process of developing a research proposal they are generally most comfortable explaining their plan to attain new knowledge and drive clinical innovation. less intuitive for the grant writing novice are how to craft the multiple application sections in a way that inspires urgency about a stated knowledge gap, curiosity about the scientific hypothesis, and confidence in the applicant’s capacity to achieve the objectives. in most successful grants, these pieces all begin to crystallize in the specific aims page and are emphasized in each subsequent section. a meditable 1. subscription-based grants databases database name web url individual subscriptions funding institutional fundinginstitutional.com grantforward grantforward.com grantscape thegrantscape.com √ grantselect grantselect.com √ pivot-rp pivot.proquest.com spin spin.infoedglobal.com http://www.amwajournal.org https://www.grants.gov/ https://www.fundinginstitutional.com/ https://www.grantforward.com https://www.thegrantscape.com/ https://www.grantselect.com/ https://pivot.proquest.com/ https://spin.infoedglobal.com amwajournal.org 42grantsmanship hurdles of early career clinician-scientists and how a medical writer can help cal writer can help the clinician-scientist ensure that these facets are consistently, concisely, and effectively conveyed throughout the full proposal. medical journals have recently published several excellent articles that speak specifically to clinicians about writing effective grant proposals.8-16 these are easy resources to share with investigators, and medical writers can mine the articles for new ideas and language that might resonate with investigators who are getting used to this genre. in one article that focuses on how to write an effective specific aims page, monte et al10 argue that a grant proposal is equivalent to a business pitch: we define the goal of grant writing as gaining financial sponsorship for planned work; like sales, a proposal requires marketing, tailoring, and a value proposition… the aims page is the point of sale for planned science and is written with the goal of research sponsorship. these authors describe their formula for writing a persuasive specific aims proposition in 4 paragraphs from defining a critical need to demonstrating the potential return on investment. two other articles also dissect the specific aims page, offering similar instruction and borrowing colorful idioms from humanities and mathematics.8,14 certain articles contain rubrics for objective evaluation of a specific aims page that may be valuable tools for a consulting medical writer.8,10 this “make the sale” mindset is beneficial throughout the grant writing process. reviewers are drawn to a grant proposal if it convinces them that (1) the investigator has delineated an urgent problem, (2) they have an innovative and scientifically credible idea to address the problem, (3) the proposed plans are well designed to test the great idea, and (4) the investigative team and research environment display the capacity to execute the plan. each of these parts is fulfilled through multiple sections of the application (figure). a clinician-scientist may feel most engaged and confident in describing the core idea or innovative elements of their plan, whereas certain sections (eg, budget, biographical sketches) may seem like mere boxes to check. however, a medical writer who helps them integrate all 4 major elements improves the probability of an outstanding impact score from the review panel. for an inexperienced applicant who lacks fluency in the jargon and expectations of grants, the instructions and review criteria found in an foa are often opaque. a medical writer can help not only by decoding the requirements but by checking the application against the foa for completeness and fulfillment of the specified review criteria (“responsiveness”). a simple way to help the clinician-scientist stay on track is to create a checklist early in the writing process and keep it updated as a dashboard while completing the application. the amwa member resource library features a template for a detailed grant checklist and schedule of milestones.17 hurdle 3: turning ancillary documents from drudgery into assets for some clinician-scientists, the list of required supporting documents is a daunting barrier. often, an investigator either spends many precious hours producing these from scratch or hurriedly produces subpar documents that likely dampen reviewers’ confidence. a medical writer can help elevate the application by introducing resources that lighten the investigator’s learning curve and boost document quality. sometimes useful tools are readily available, and we may just need to point the investigator in the right direction. for example, the national center for biotechnology information provides a free online app called sciencv, which helps investigators build a complete and compliant nih-style biosketch.18 another way to help address this barrier is by encouraging smart use of institutional boilerplate text. many universities seek to help their investigators with grant applications by maintaining boilerplate that describes facilities, resources, expertise, and administrative structures. although these resources can be a good building block, beware of 2 possible flaws. first, watch for text that has grown stale after a couple of years on the shelf, both to eliminate outdated information and to ensure inclusion of newer resources. if the clinician-scientist is unsure about key details, reach out to the relevant core facility or office to ask for a fresh review of the information. a medical writer employed at an academic institution can benefit all affiliated investigators by maintaining a current boilerplate library. figure. four main elements of a grant proposal that the investigator must illustrate for reviewers. multiple sections of the proposal combine to build confidence in each element. problem scientific literature standard of care knowledge gap capacity personnel / biosketches facilities equipment letters of support great idea aims / hypotheses preliminary data plan approach innovation budget human / animal http://www.amwajournal.org amwajournal.org 43grantsmanship hurdles of early career clinician-scientists and how a medical writer can help second, no matter how complete and current the information is, applicants should not simply copy unmodified generic boilerplate text into an application. coherence among the many pieces of an application signals to reviewers that the investigator has given careful thought to everything that needs to work together to achieve the research aims. therefore, resources that have no relevance should be deleted, and the generic text should be enriched with tailored sentences or phrases that emphasize relevance to the project (table 2). mentality by encouraging them to seek the following kinds of feedback. program officers working in the nih institutes are known for the constructive advice they offer investigators. they are often helpful in identifying programs and study panels in which a research idea would find its best fit, sharing the upcoming release of new foas, explaining the grant review processes, and decoding reviewers’ critiques.21 in most cases, an nih foa lists contact information for the appropriate program officer(s). alternatively, a great resource for identifying program officers (as well as institutes and review panels) relevant to the clinician-scientist’s project idea is the matchmaker search tool at the research portfolio online reporting tools website.22 although program staff in other agencies or organizations may be less visible, it is worth trying to identify them for similar assistance. an investigator should initiate the conversation about their proposal concept by email, share a draft of the specific aims, and propose setting up a call or virtual meeting for feedback. many clinician-scientists seem reticent to reach out for this help; a writing consultant can provide critical assistance in facilitating this process and eliciting valuable feedback. peers and colleagues are an invaluable source of grant feedback for investigators at any career stage. fellow researchers can provide insight from various angles, such as: has the investigator made a persuasive argument for an important knowledge gap that must be filled? does the proposed approach stand up to technical scrutiny? how well does the proposal address review criteria found in the foa? medical writers bring legitimate insight into these questions as well, but peers can take it to an important next level. sometimes part of our role is to encourage seeking that help from a couple of trusted individuals and plan it into the writing timeline. many institutions seek to elevate the presubmission grant review process by organizing internal mock review panels often targeted toward their junior faculty and trainees.23,24 not only does this facilitate feedback from 4 or 5 reviewers at once, but it also introduces the dynamic of a live panel discussion. data collected at one institution demonstrated the effectiveness of internal review for increasing success of submissions to nih.24 the greatest challenge in leveraging this resource is proactive planning. an investigator must request review by a mock panel and supply a draft of at least the specific aims page, several weeks before the funding agency’s deadline. when such an opportunity exists, medical writers should encourage working far enough ahead to secure this assistance. table 2. examples of tailoring verbiage to a specific proposal grant section points of emphasis tailored sentence example facilities/ resources access, relevance dr smith has an agreement with the gait analysis lab to support monitoring participants’ fluidity of motion postsurgery (see letter of support). equipment location, features, purpose the pi’s division houses a pet/ct scanner (make/model) with respiratory and cardiac gating to reconstruct phase-matched images. it will be used to screen study enrollees for lung cancer recurrence. biosketch– personal statement commitment, role as a co-investigator, i will coordinate the key informant interviews in aim 2, to include securing irb approval and ensuring protocol-adherent interviews, transcription, and coding. pi, principal investigator; pet/ct, positron emission tomography/computed tomography an excellent way to demystify the components of a complete application is to provide examples of proposals that were funded in the past. ideally, an investigator has mentors who will share recent grants as models. a staff medical writer can facilitate the sharing process by gathering and managing a small library of model proposals from willing faculty. furthermore, multiple nih institutes provide online access to lightly redacted copies of grant proposals they have funded.19 examples of applications to other funders can be more difficult to find; however, one online resource, open grants,20 maintains an open repository of proposals submit-ted to a variety of public and private sector organizations. hurdle 4: shedding the “bunker mentality” clinician-scientists are often forced to fit their grant writing into odd pockets of time around their more rigid clinical schedule. those who have received minimal research mentorship may not fully appreciate the benefits of robust initial review by a colleague before a proposal goes to an anonymous review panel. consequently, grant writing tends to be a solitary endeavor; this “bunker mentality” can deprive proposals of objective external feedback and editing. medical writers can help investigators resist this bunker http://www.amwajournal.org amwajournal.org 44grantsmanship hurdles of early career clinician-scientists and how a medical writer can help finally, medical writers can play the role of document editor to help maximize a proposal’s clarity, completeness, conformity to instructions, and professionalism. this service may range from early partnership in the conceptual stages to copy editing at the final stage. it is important to remember that many early career clinician-scientists are looking for more than a batch of corrections. we can create a true professional development experience if we partner with our clinician-scientist colleagues and help them think through the communication strategy. a 2020 post to the amwa blogs cogently described the editing technique of providing “informational support,”25 that is, you “focus on an author’s development by explaining why changes are being suggested and offering to answer questions about editing recommendations/comments.” a sense of partnership and a supportive tone help ensure investigators will return for assistance with resubmissions and future proposals. conclusion grant seeking is an integral part of the landscape in academic medicine. clinician-scientists who aim to advance their research programs and find backing for their ideas will continue to need skilled grant writing assistance. medical writers can add value across the full scope of documents needed in any given proposal. we can also help our clinician-scientist colleagues see the finished product from the vantage point of funding organizations and peer reviewers. this will not only increase the likelihood of a funded proposal, but also cultivate a clinician-scientist’s grantsmanship expertise for future applications. acknowledgment i thank heather c. mcneill, ma, els, and jennifer k. peterson, phd, for their constructive reviews of the article. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. the author received partial salary support from nih funding for the nebraska pediatric clinical trials unit (ug1 od024953). contents of the article are solely the responsibility of the author and do not necessarily represent the official views of nih. author contact: matthew.sandbulte@unmc.edu references 1. what is an academic grant writer/editor? amwa blogs. published 2022. accessed june 16, 2022. https://blog.amwa.org/what-is-anacademic-grant-writer-editor 2. mckinney re, jr. the daunting career of the physicianinvestigator. acad med. 2017;92(10):1368-1370. 3. gosain a, chu di, smith jj, neuman hb, goldstein am, zuckerbraun bs. climbing the grants ladder: funding opportunities for surgeons. surgery. 2021;170(3):707-712. 4. bensken wp, nath a, heiss jd, khan oi. future directions of training physician-scientists: reimagining and remeasuring the workforce. acad med. 2019;94(5):659-663. 5. mistry ms, williams ae. read one, write one, get funded: two junior pediatric hospitalists delve into clinical research and grant writing. hosp pediatr. 2021;11(1):e6-e8. 6. hall ak, mills sl, lund pk. clinician-investigator training and the need to pilot new approaches to recruiting and retaining this workforce. acad med. 2017;92(10):1382-1389. 7. simpson rl, cornfield dn, burris je. novel prescriptions from medical schools for physician-scientist training and engagement in the twenty-first century. acad med. 2021;96(4):512-515. 8. santen rj, barrett ej, siragy hm, farhi ls, fishbein l, carey rm. the jewel in the crown: specific aims section of investigatorinitiated grant proposals. j endocr soc. 2017;1(9):1194-1202. 9. sauer rm, gabbi c. grantsmanship: what? who? how? eur j intern med. 2018;57:22-24. 10. monte aa, libby am. introduction to the specific aims page of a grant proposal. acad emerg med. 2018;25(9):1042-1047. 11. gabbi c, sauer rm. grantsmanship writing tips: background, hypothesis and aims. eur j intern med. 2019;61:25-28. 12. sauer rm, gabbi c. grantsmanship writing tips: significance, innovation and impact. eur j intern med. jul 2019;65:26-28. 13. gabbi c, sauer rm. grantsmanship writing tips: the experimental design. eur j intern med. 2019;64:21-23. 14. goldstein am, balaji s, ghaferi aa, et al. an algorithmic approach to an impactful specific aims page. surgery. 2021;169(4):816-820. 15. guyer ra, schwarze ml, gosain a, maggard-gibbons m, keswani sg, goldstein am. top ten strategies to enhance grant-writing success. surgery. 2021;170(6):1727-1731. 16. ingraham a, emamaullee j, johnston f, fahrenholtz m, goldstein am, keswani sg. a practical guide to writing a competitive k award application. surgery. 2021;170(5):1411-1417. 17. rna editing. grant checklist example. amwa. published 2019. accessed june 16, 2022. https://www.amwa.org/page/resource_ library_list#grants 18. sciencv: science experts network curriculum vitae. national library of medicine's national center for biotechnology information. accessed june 22, 2022. https://www.ncbi.nlm.nih. gov/sciencv/ 19. samples: applications, attachments, and other documents. national institutes of health. updated june 14, 2022. accessed june 22, 2022. https://grants.nih.gov/grants/how-to-applyapplication-guide/resources/sample-applications.htm 20. white e. open grants: about. ogrants. accessed june 11, 2022. https://www.ogrants.org/about.html 21. robertson jd, russell sw, morrison dc. how to find the appropriate program and grant mechanism for your idea. in: robertson jd, russell sw, morrison dc. the grant application writer's workbook national institutes of health version. grant central; 2019. 22. research portfolio online reporting tools (report). national institutes of health. accessed september 7, 2022. https://report. nih.gov/ 23. huang x, dovat s, mailman rb, thiboutot dm, berini d, parent lj. building a system to engage and sustain research careers for physicians. acad med. 2021;96(4):490-494. 24. thomas hs, brodsky mb, ewen jb, et al. internal grant review to increase grant funding for junior investigators. ann neurol. 2017;82(4):497-502. 25. bailey mb, benson k, weber-main, am. applying writing tutors’ communication techniques as a medical editor. amwa blog. published september 21, 2020. accessed june 16, 2022. https:// blog.amwa.org/applying-writing-tutors-communicationtechniques-as-a-medical-editor http://www.amwajournal.org https://blog.amwa.org/what-is-an-academic-grant-writer-editor https://blog.amwa.org/what-is-an-academic-grant-writer-editor https://www.amwa.org/page/resource_library_list#grants https://www.amwa.org/page/resource_library_list#grants https://www.ncbi.nlm.nih.gov/sciencv/ https://www.ncbi.nlm.nih.gov/sciencv/ https://grants.nih.gov/grants/how-to-apply-application-guide/resources/sample-applications.htm https://grants.nih.gov/grants/how-to-apply-application-guide/resources/sample-applications.htm https://www.ogrants.org/about.html https://report.nih.gov/ https://report.nih.gov/ https://blog.amwa.org/applying-writing-tutors-communication-techniques-as-a-medical-editor https://blog.amwa.org/applying-writing-tutors-communication-techniques-as-a-medical-editor https://blog.amwa.org/applying-writing-tutors-communication-techniques-as-a-medical-editor v38 n4 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 16 in the hallowed halls of healing’s grace, where life and hope entwine, their embrace, i stand as a black man, a vessel strong, a symphony of compassion, an ode to belong. in medicine’s tapestry, a brush i wield, with empathy’s hues, a masterpiece revealed, each patient’s story, a canvas divine, where healing strokes merge, transcending time. with hands that bear both ancient scars and grace, i touch weary souls, their burden i embrace, the pulse of their pain, the whispers they hold, i listen, i heal, with a love so bold. oh, juneteenth, your resonant chimes, awaken echoes of bygone times, when shackles clung tight, hearts bled in despair, yet hope birthed anew in the realm of care. i close my eyes, visions spring to life, ancestors’ strength beneath sun’s golden strife, in cotton fields’ torment, they found might, their spirits ablaze, stars shining so bright. through anguish, they danced with resilience untamed, a symphony of voices, freedom proclaimed, from depths of their souls, liberation did flow, unyielding, unwavering, like rivers that grow. george ongoro, ms-2 / university of minnesota medical school, duluth, mn resonant melodies of healing: a juneteenth symphony in medicine creative writing today, their spirits reside deep within me, their legacy guides, a beacon to see, with every breath, their dreams i embrace, a torchbearer for justice, in life’s vibrant race. oh juneteenth, i hear your triumphant song, a chorus of history, echoing strong, a day to honor, celebrate, reflect, on journeys endured, lives intersect. in medicine’s embrace, we stand united, with healing hands and hearts ignited, healers, dreamers, beacons of light, navigating shadows, dispelling the night. for in this poem’s tapestry, emotions cascade, let freedom’s essence forever pervade, may the world pause, listen, enraptured, and stirred, by juneteenth’s echoes, hearts forever interred. so let this poem transcend the earthly realm, a lyrical gem, in brilliance overwhelm, a testament to resilience, love’s vibrant hue, where healing and juneteenth intertwine, anew. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: ongor005@d.umn.edu http://www.amwajournal.org v38 n3 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 45 theme article council for programs in technical & scientific communication “2023 cptsc conference” september 22-23, 2023, charleston, sc https://conference.cptsc.org/ american copy editors society/aces: the society for editing “vcon23” september 27-29, 2023, virtual https://aceseditors.org/conference/vcon23-central plain language association international “connecting cultures: creating bridges with clear communication” september 27-29, 2023, buenos aires, argentina https://plainlanguagenetwork.org/conferences/2023-buenos-airesargentina/ international society for medical publication professionals “ismpp academy: prep! practical resources to elevate publications” september 28-29, 2023, philadelphia, pa https://whova.com/web/ sbinx2ue7txb9uyy4bitsgqeuabq69mvumfdult4eda%3d/ society of clinical research associates “2023 annual conference” september 29-october 1, 2023, montreal, quebec, canada https://www.socra.org/annual-conference/2023/2023-annualconference-information/ regulatory affairs professionals society “raps convergence 2023” october 3-5, 2023, montreal, quebec, canada https://www.raps.org/events/raps-convergence-2023 national association of science writers “sciencewriters2023” october 6-10, 2023, boulder, co https://www.nasw.org/events/nasw-science-writers-nationalconference-sciwri23-annual-meeting-2023-boulder-colorado academy of communication in healthcare/international association on communication in healthcare “international conference on communication in healthcare” october 22-25, 2023, rio mar, puerto rico https://www.achonline.org/icch2023 regulatory affairs professionals society “raps european clinical and risk management conference” october 24-26, 2023, brussels, belgium https://www.raps.org/events/raps-european-clinical-and-riskmanagement-conference american medical writers association amwa medical writing & communication conference october 25-28, 2023, baltimore, md https://www.amwa.org/page/conference drug information association “dia japan 2023” november 5-7, 2023, ariake, japan https://www.diaglobal.org/en/flagship/dia-japan-2023 drug information association “dia canada annual meeting” november 7-8, 2023, gatineau, qc, canada https://www.diaglobal.org/en/conference-listing/meetings/2023/11/ canada-annual-meeting european medical writers association “56th emwa conference” november 9-24, 2023, virtual https://www.emwa.org/conferences/future-conferences/ american public health association “apha 2023 creating the healthiest nation: overcoming social and ethical challenges” november 12-15, 2023, atlanta, ga https://www.apha.org/events-and-meetings/annual afdo/raps healthcare products collaborative “artificial intelligence summit” november 14-16, 2023, cincinnati, oh https://www.raps.org/events/artificial-intelligence-summit-11-2023 afdo/raps healthcare products collaborative and the food and drug administration “combination products summit 2023” november 28-december 2, 2023, fort worth, tx https://www.raps.org/events/combination-products-summit-2023 international society for medical publication professionals “2024 european meeting of ismpp” january 23-24, 2024, london, uk https://www.ismpp.org/european-meeting alliance for continuing education in the health professions “the alliance 2024 annual conference” february 5-8, 2024, new orleans, la https://www.acehp.org/your-learning/events american association for the advancement of science “toward science without walls” february 15-17, 2024, denver, co https://meetings.aaas.org/ drug information association “dia europe 2024” march 12-14, 2024, brussels, belgium https://www.diaglobal.org/en/flagship/dia-europe-2024 calendar of meetings http://www.amwajournal.org https://conference.cptsc.org/ https://aceseditors.org/conference/vcon23-central https://plainlanguagenetwork.org/conferences/2023-buenos-aires-argentina/ https://plainlanguagenetwork.org/conferences/2023-buenos-aires-argentina/ https://whova.com/web/sbinx2ue7txb9uyy4bitsgqeuabq69mvumfdult4eda%3d/ https://whova.com/web/sbinx2ue7txb9uyy4bitsgqeuabq69mvumfdult4eda%3d/ https://www.socra.org/annual-conference/2023/2023-annual-conference-information/ https://www.socra.org/annual-conference/2023/2023-annual-conference-information/ https://www.raps.org/events/raps-convergence-2023 https://www.nasw.org/events/nasw-science-writers-national-conference-sciwri23-annual-meeting-2023-boulder-colorado https://www.nasw.org/events/nasw-science-writers-national-conference-sciwri23-annual-meeting-2023-boulder-colorado https://www.achonline.org/icch2023 https://www.raps.org/events/raps-european-clinical-and-risk-management-conference https://www.raps.org/events/raps-european-clinical-and-risk-management-conference https://www.amwa.org/page/conference https://www.diaglobal.org/en/flagship/dia-japan-2023 https://www.diaglobal.org/en/conference-listing/meetings/2023/11/canada-annual-meeting https://www.diaglobal.org/en/conference-listing/meetings/2023/11/canada-annual-meeting https://www.emwa.org/conferences/future-conferences/ https://www.apha.org/events-and-meetings/annual https://www.raps.org/events/artificial-intelligence-summit-11-2023 https://www.raps.org/events/combination-products-summit-2023 https://www.ismpp.org/european-meeting https://www.acehp.org/your-learning/events https://meetings.aaas.org/ https://www.diaglobal.org/en/flagship/dia-europe-2024 v37 n3 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 16 abstract according to the centers for disease control and prevention, about 1 in 4 americans have a disability.1 as the population ages, there is an increased need for technology and accessibility (equal access), including web accessibility. accessibility is often defined in terms of 2 distinct measures: compliance with standards and usability for people with disabilities. the most common accessibility guidelines are the web content accessibility guidelines (wcag) 2.0/2.1 and the section 508 of the rehabilitation act. they are written to support the accessibility of html content. according to the w3c web accessibility initiative, “web accessibility means that websites, tools, and technologies are designed and developed so that people with disabilities can use them.” ² business owners, medical writers, technical editors, social media managers, web designers, and information technology administrators play a critical role in ensuring a better web experience for all of us. in this article, we share practical ideas for you to show your commitment to diversity, equity, and inclusion with changes you can make to your website and content today. accessibility solutions, such as using image alternative text, camel case in hashtags, white space around headings, margins, indentations, and columns, and strategically using fonts and color contrasting, are a few of many effective ways to provide accessible content to a larger audience. we also share other ways to address accessibility with creative strategies, such as podcasting. for medical communicators, strategies in communication, such as descriptive language and the use of storytelling techniques, are vital to ensuring your audience has a clear understanding of the message. according to the centers for disease control and prevention, about 1 in 4 americans have a disability.1 disabilities can be situational, temporary, or permanent. some are hidden, such as chronic fatigue syndrome, diabetes, depression, visual and auditory disabilities, or learning difficulties. as the population ages, there is an increased need for technology and accessibility (equal access), including web accessibility. most information today is shared via the web, and the web is the first impression someone gets of your organization. if your information isn’t accessible to those who have different abilities and disabilities, your information will not have the desired effect, and your organization’s reputation may be in jeopardy. think about it this way—what thoughts do you have about information and organizations when you cannot access their information on the web? maybe they choose not to have a website, or the colors give you a headache, or maybe that autoplay video has a sound you find irritating, so you turn it off. how do you feel about the organization and/or the information they are trying to share at that moment? for people with different abilities and/or disabilities, this is a routine experience for everything in the world around them. accessibility is often defined in terms of 2 distinct measures: compliance with standards and usability for people with disabilities. according to the w3c web accessibility initiative, “web accessibility means that websites, tools, and technologies are designed and developed so that people with disabilities can use them.”2 so, why should you care about accessibility? here are several reasons: • it helps ensure equal access. • you’ll broaden your audience and expand your customer base. • it means search engines will be able to read your site more completely. • it’s done for legal reasons. • it generates a positive media response. • it supports corporate social responsibility. • it’s also the right thing to do. this builds trust and brand loyalty. • it improves usability for users in general. we all benefit from a win-win approach. business owners, medical writers, technical editors, social media managers, web designers, and information dean colston, phd; rebecca fein, dhsc; killian kleffner, phd; and vanessa saunders, phd / a flock of scientists, llc, phoenix, az diversity, equity, and inclusion embraces accessibility social media http://www.amwajournal.org https://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf https://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf https://www.accme.org/sites/default/files/2021-06/902_20210615_2020%20data%20report.pdf https://www.accme.org/sites/default/files/2021-06/902_20210615_2020%20data%20report.pdf https://accme.org/sites/default/files/2021-06/884_20210624_new%20standards%20standalone%20package.pdf https://accme.org/sites/default/files/2021-06/884_20210624_new%20standards%20standalone%20package.pdf https://accme.org/sites/default/files/2021-06/884_20210624_new%20standards%20standalone%20package.pdf https://jamanetwork.com/journals/jama/article-abstract/2778925 https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label https://accme.org/sites/default/files/2021-06/884_20210624_new%20standards%20standalone%20package.pdf https://accme.org/sites/default/files/2021-06/884_20210624_new%20standards%20standalone%20package.pdf https://accme.org/sites/default/files/2020-12/883_20201210_standards%20for%20integrity%20and%20independence%20toolkit.pdf https://accme.org/sites/default/files/2020-12/883_20201210_standards%20for%20integrity%20and%20independence%20toolkit.pdf amwajournal.org 17diversity, equity, and inclusion embraces accessibility technology administrators play a critical role in ensuring a better web experience for all of us. many people like graphs and other data visualizations, but these can create difficulty for users who are visually impaired and/or blind. why? screen readers may not always read and interpret these displays correctly. a screen reader is a software program that allows people who are blind and have low vision to read the content on a computer screen. it's done with a voice synthesizer or braille display. so, it is important to have a text description and/or plain text summary to ensure that the data can be accessed by everyone. guidelines the most common accessibility guidelines are the web content accessibility guidelines (wcag) 2.0/2.1 and the section 508 of the rehabilitation act. they are written to support the accessibility of html content. the wcag 2.0 have long been the gold standard for accessibility on the web. they were published in 2008. wcag 2.1 were released in 2018, and it covers a wide range of recommendations for making web content more accessible. three levels of wcag 2.0/2.1 conformance wcag 2.0 a, aa, and aaa standards all have success criteria that must be met. a—minimal compliance aa—acceptable compliance (aim here) aaa—optimal compliance the principles underlying wcag 2.0 and 2.1 make the acronym “p.o.u.r.”: • perceivable • operable • understandable • robust first, your content must be perceivable. second, the interface elements in the content must be operable. third, the content and controls must be understandable. finally, your content must be robust enough to work with current and future technologies. what are some easy and fast changes you can make to your website and content today to be more inclusive? we have some practical ideas for you to show your commitment to diversity, equity, and inclusion. accessible social media best practices alternative text is the first principle in web accessibility. web accessibility is likely to become a major ranking factor for google in the future. adding relevant alternative text to your images is one easy and effective way of doing it to improve your visibility. an alternative text is a written description of an image or graphic that a screen reader can read out loud. alternative text is often referred to as “alt text,” “alt tags,” or “alt attributes.” it communicates the graphic’s purpose and context. it’s not too long, so aim for a maximum of 100–125 characters. in addition, don’t feel like you need to describe everything. one can think of it as an alternative to viewing the image for users who are blind or have low vision. it is also helpful for people with sensory processing disorders or learning disabilities. a missing alternative text is one of the most common image accessibility complaints, and it’s one of the easiest things to fix. an alt tag can help your photo be more accessible and discoverable. it can also boost your image search engine optimization. remember, google is pushing for the use of alt text because it can’t see the images that you upload to your site. but alt text helps the search engine categorize your photos. image alt text when using image alt text, it should not include “picture of” or “image of.” a screen reader already tells the user this information. on the other hand, it is acceptable to use the words “this screenshot” or “this illustration” in your alt text. in certain situations, it may be helpful to distinguish between paintings, screenshots, or illustrations. but it’s a best practice to avoid the more generic use of terms, such as image, icon, or picture. here’s an example of a good alt text: two chocolate brownies stacked on top of each other with blueberries, raspberries, and mint leaves on top (figure). figure. two chocolate brownies stacked on top of each other with blueberries, raspberries, and mint leaves on top. © [nata vkusidey] / adobe stock. http://www.amwajournal.org amwajournal.org 18diversity, equity, and inclusion embraces accessibility here’s an example of a substandard alt text: brownies as a general rule, there must always be an alternative description tag for every image. however, if you wish for the screen reader to just bypass or jump over the image, a null or "" is put in the text section of the tag: for example, <alt> "" </>. in this case, a decorative image doesn’t need alternative text. a decorative image is used only to evoke a feeling or reinforce accompanying copy rather than to convey meaning on its own. simply putting a null mark in every alt text would technically pass a lot of software-generated validation tools, but the image would not be accessible. again, it's important that whoever is designing or adding content to the page makes a decision regarding the purpose of the image and what it is intended to convey. when in doubt, it is acceptable to add descriptive alternative text. complex images and long descriptions complex images can be challenging for many people to understand. for example, people with low vision, learning disabilities, and limited subject-matter experience often find them confusing. a good practice is to simplify the image or graphic. for charts, graphs, diagrams, illustrations, and other complex images, simple alt text may not be sufficient to convey the information. in this case, the image’s alt text should direct the user to the long description conveyed by the image. here’s a tip: use lists, headings, and other structural elements to organize content in a long description. headings headings are an important part of an accessible website. sections must have headings that identify them. make sure your content is well-formatted with headings and lists. that way, readers can use their screen reader’s quick navigation keys to find their way. this adds clarity and orients users to the overall document structure. navigation your website needs to be navigable. but can it be navigable without a mouse? people who are blind or have low vision use the keyboard to navigate, not a mouse. for a website to be accessible, it must work without the use of a mouse. color and contrast your website needs to be distinguishable for an optimal experience. what are some best practices on using color? text (paragraph text) and interactive portions should have a contrast ratio of 4.5:1. for large text, your text ratio can be 3:1.3 color alone should not convey information on a website. why? some people are blind, have color blindness, or have color-contrast deficiencies. the most common form of color deficiency is deuteranopia, red-green. plus, the most common offender: links. other best practices one should consider include: • avoid using the following color combinations: red/ green, blue/green, and yellow/red. • use plenty of white space. two reputable contrast checkers that should be included in your toolbox: https://userway.org/contrast/000000/ffffff https://webaim.org/resources/contrastchecker use camel case in hashtags to make your hashtags more accessible, capitalize the first letter of each word. this is called "camel case.” when you capitalize the first letter of each word, screen readers now have the indication they need and are much more likely to read the hashtag as intended. note how these 2 examples are written: #stateofmentalhealthinamerica2021 #notcamelcase the first example is using camel case in hashtags; the second is not. in the same theme, capitalize the first letter of each word in a url. according to the american foundation for the blind, this will make it easier to understand for people who are blind or have low vision when they use screen readers.4 here’s the bottom line: it's not only friendlier for people who are blind or visually impaired who use screen readers, but it's also friendlier for people with dyslexia or cognitive disabilities. in essence, #camelcase is easier for everyone to read. emojis and gifs limit the use of nontext objects like emojis and gifs. you can write a description of an emoticon in parenthesis or brackets after sending it. :) <smiling face> in addition, double-check the emoji’s description before using them. plus, place emojis at the end of posts and tweets to avoid clarity issues. http://www.amwajournal.org amwajournal.org 19diversity, equity, and inclusion embraces accessibility gifs and animations avoid sharing gifs that contain rapid flashing content that may trigger epileptic seizures in people with photosensitive epilepsy. plus, ongoing animation can be distracting for people with attention deficit hyperactivity disorder (adhd). multimedia content audio and video content can be difficult for some users. for example, people who are deaf or blind or have low vision or hearing loss may not be able to perceive video or audio content. in addition, people with cognitive impairments may find the pace of multimedia content challenging. one of the best alternatives for multimedia content is a text transcript. written transcripts are recommended for all video and audio content. in that theme, videos should be described and captioned. closed captioning has been around for many years. it can help make a video or movie more accessible. it benefits people with learning disabilities, adhd, autism, and hearing loss. in addition, it helps people in other ways, such as when we are in a noisy environment or if our audio is poor. captions can also support us if the person in the video is a fast talker or has an accent. some captioning apps include mixcaptions, clipomatic, autocap, kapwing, clips, and threads. on the other hand, an audio description is a newer technology that can supplement closed captioning.5 it is a form of narration used to provide information surrounding key visual elements in videos for consumers who are blind or have low vision. in other words, you can think of audio description as providing a verbal version of the visual image. live-streaming tips for accessibility for live-streaming events, consider these 3 tips: 1. use video services that have live-captioning capabilities like zoom or google meet. 2. provide a transcript or fully captioned video soon after your event ends. 3. hire an on-camera interpreter for an additional level of accessibility. images with texts as a general rule, images of text are not allowed. if you cannot avoid images of text, it’s best to have the same text in the alt attribute. remember, google likes text-based content. exceptions can be made for company logos, brand names, and other situations in which the way that the text is presented visually is crucial to its meaning. white space standardize site structure and page creation by liberal use of white space. active white space is intentionally used to create structure and flow on a page. it can serve other purposes, such as helping readers to process the text more efficiently and directing them to important information. be sure to use white space around headings, margins, indentations, and columns. learning how to properly use white space can garner attention, sales, and impact. font style font style is a critical element of accessible website design. in this case, readability is the most important factor. choose a font that has easily recognizable characters, such as sans serif fonts: arial, calibri, helvetica, or verdana. “the us department of health & human services unofficially recommends the following fonts for pdf files: times new roman, verdana, arial, tahoma, helvetica, and calibri.”6 the minimum font size on your website is 16 points or 16 px. it depends on the font because fonts tend to vary. when users zoom in on the page, they have to be able to zoom to 200% without affecting the content. finally, avoid italics, all caps, bold type, or other formatting that could affect readability. acronyms, abbreviations, and jargon spell out acronyms when they’re first introduced in your text to your readers. plus, avoid abbreviations, jargon, and figurative language. web content reading level create content for the appropriate reading level. the general standard for web content is eighth grade. the goal is to keep sentence structure simple and paragraphs short. it’s ok to be conversational, but keep it clear and concise. this helps many users with cognitive and visual disabilities. adding hyperlinks avoid these words or phrases in links: • click here • read more • more info here • link to (some link destination) it is best to tag the actual message as a hyperlink. if it is a link, it automatically means click here. another way to address accessibility is with creative strategies such as podcasting. podcasting can use audio to http://www.amwajournal.org https://userway.org/contrast/000000/ffffff?fg=000000&bg=ffffff https://webaim.org/resources/contrastchecker amwajournal.org 20diversity, equity, and inclusion embraces accessibility assist the visually impaired, but it can also have text captions or a transcript to assist people with hearing loss. develop a new strategy—present like a podcaster as a medical communicator, drafting and scripting presentations can become an important part of your job, in addition to making presentations oneself. a great way to learn how to inform, educate and entertain an audience without relying solely on visual aids can be derived from the art of podcasting. so... what is a podcast? one way to think of a podcast is a television show for the ears. podcasts are a series of recorded audio files that, in a similar manner to a television show, tend to tell a story with a focus on a specific theme, generally within 25 to 45 minutes. much like a presentation they can be used to inform, educate, or entertain an audience. leaning on lessons learned from professional podcasters and storytellers, the following are some key strategies to make presentations audio friendly. scripting the introduction • focus on the subject and clarify it to listeners by telling the audience what to expect from the presentation. (eg, “you will learn or discover x as a result of the findings that will be shared today.”). • insert a question to engage the audience and start the thought process. • establishing the concept with the necessary background (eg, “in order to understand x, let me first explain y.”).7 scripting the narrative to ensure the speaker is not reliant on visual aids to explain key findings. • using clear, descriptive language that emphasizes the main points. – recommended: the research found that feature x is expressed in 30% of the population and feature y in 60% of the population, with other features representing 10%, indicating that feature y is more prevalent in z population (speaker uses a pointer to highlight information on the chart). – not recommended: if you look at the above pie chart, in which the blue represents feature x and the green represents feature y, you will see that feature y is more widely expressed in our population (listener has no concept of how wide the gap in expression is or the expression level of other features). • use delivery notes within the script to introduce pauses, emphasis, pace, and other strategies to prevent the audience from losing focus due to a monotone presentation.8 script the conclusion to emphasize the main point of the presentation. summary with approximately 25% of the us population having a disability, a focus on the use of accessibility features in technology and comprehensive communication is critical for the clear and accurate dissemination of knowledge. for an organization, the benefits of presenting accessible content can range from ensuring that a broad customer base understands the value the organization provides to legally meeting compliance standards. accessibility solutions, such as using image alternative text and strategically using fonts and color contrasting, are a few of many effective ways to provide accessible content to a larger audience. for medical communicators, strategies in communication, such as descriptive language and the use of storytelling techniques, are vital to ensuring your audience has a clear understanding of the message. author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. author contact: aflockofscientists@gmail.com references 1. centers for disease control and prevention. cdc: 1 in 4 us adults live with a disability. centers for disease control and prevention website. published august 16, 2018. accessed april 5, 2022. https://www.cdc.gov/media/releases/2018/p0816-disability.html 2. w3c web accessibility initiative. introduction to web accessibility. w3c website. published february 2005. accessed march 24, 2022. https://www.w3.org/wai/fundamentals/ accessibility-intro/ 3. webaim. contrast and color accessibility: understanding wcag 2 contrast and color requirements. webaim website. updated january 9, 2021. accessed february 23, 2022. https://webaim.org/ articles/contrast/ 4. american foundation for the blind. afb's social media accessibility guidelines. afb website. updated august 27, 2021. accessed february 22, 2022. https://www.afb.org/consulting/afbaccessibility-resources/afbs-social-media-accessibility-standards 5. american council of the blind. the audio description project. audio description project website. accessed january 8, 2022. https://adp.acb.org/ 6. bureau of internet accessibility. best fonts to use for website accessibility. bureau of internet accessibility website. published may 20, 2017. accessed may 2, 2022. https://www.boia.org/blog/ best-fonts-to-use-for-website-accessibility 7. macadam a. how audio stories begin. npr website. published july 26, 2016. accessed april 7, 2022. https://training.npr. org/2016/07/26/how-audio-stories-begin/ 8. hammer d. podcast basics: how to write a podcast script. castos website. published april 29, 2022. accessed may 4, 2022. https:// castos.com/podcast-script http://www.amwajournal.org v38 n1 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 63 dia europe “dia europe 2023” march 22-24, 2023 basel, switzerland https://www.diaglobal.org/flagship/dia-europe-2023 aces: the society for editing “aces evolve: the power of editing” march 23-25, 2023 columbus, oh https://aceseditors.org/conference/aces-2023-columbus american pharmacists association “apha 2023” march 24-27, 2023 phoenix, az https://aphameeting.pharmacist.com/ international society for medical publication professionals “19th annual meeting of ismpp” april 24-26, 2023 washington, dc https://connect.ismpp.org/events/calendar association of independent information professionals “#aiip23: the annual conference for info-entrepreneurs” in-person: april 2730, 2023 wrap-around & virtual events: april 24-may 5, 2023 milwaukee, wi https://www.aiip.org/conference association of clinical research professionals “acrp 2023” april 28-may 1, 2023 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http://www.amwajournal.org https://www.diaglobal.org/flagship/dia-europe-2023 https://aceseditors.org/conference/aces-2023-columbus https://aphameeting.pharmacist.com/ https://connect.ismpp.org/events/calendar https://www.aiip.org/conference https://2023.acrpnet.org/ https://www.councilscienceeditors.org/annual-meeting-2023 https://www.councilscienceeditors.org/events/upcoming-events/2023-cse-annual-meeting/ https://www.emwa.org/conferences/future-conferences https://www.raps.org/events/2023-euro-convergence https://summit.stc.org/ https://customer.sspnet.org/ssp/ssp/am23/home.aspx?hkey=22abbe1c-7a5d-45c5-9a39-183b3535d1b6 https://customer.sspnet.org/ssp/ssp/am23/home.aspx?hkey=22abbe1c-7a5d-45c5-9a39-183b3535d1b6 https://www.diaglobal.org/en/flagship/dia-2023 contents v37 n4 winter 2022 4 6 11 19 23 25 29 35 37 40 from the guest editor the future of medical writing: gazing into the crystal ball � art gertel theme articles the evolution of medical communication � suzanne devandry globalization and the future of medical writing � julia cooper, jeannene butler, kelley hill, garima pallavi, grishma kanchan, jonathan mackinnon, renee primus, matthew renda, linda yih, and nan wang technology to further medical writing: status and future vision � helle gawrylewski and nimita limaye the future of medical writing: a panel of one � lisa chamberlain james what about the audience? � kimbra edwards topical features reflections on working as a medical writer with a disability and how medical writers can be disability allies � jeanette m. towles on to the next level: clinicaltrials.gov goes (more fully) plain! � thomas m. schindler freelance focus � brian bass, lori de milto, cathryn d. evans, and gail v. flores q1: how can i prepare my freelance business for the recession? q2: did you freeze or increase your pricing/rates at the beginning of the pandemic? if you did, are you making any further changes to those rates now? q3: how do you handle payments from international clients? is there an optimal payment method that has worked for you? everyday ethics first, do no harm: ethical considerations surrounding the environmental impact of our digital content � alisa bonsignore 55 40 29 editor-in-chief michael g. baker, phd guest editor art gertel, phd managing editor rachel mosher, ma section editors progress in publications qing zhou, phd, els regulatory insights jennifer bridgers, ms, mwc science series naomi bishop, md social media jennifer minarcik, ms statistically speaking thomas m. schindler, phd everyday ethics julie ravo, ba, ma freelance focus ruwaida vakil, msc technology talk kate mckiernan, ma, els ce craft corner haifa kassis, md practical matters elizabeth kukielka, pharmd, ma, ms, mwc regular contributors freelance focus brian bass, mwc melissa l. bogen, els sherri bowen, ma, els lori de milto, mj cathryn d. evans gail v. flores, phd phyllis minick in the service of good writing laurie endicott thomas, ma, els editors in memoriam lori l. alexander, mtpw, els, mwc ronald j. sanchez 2022–2023 president elise eller, phd 2022–2023 board liaison joanna pendergrass, dvm 2022–2023 staff liaison shari rager, ms, cae executive director susan krug, ms, cae graphic designer amy boches, biographics editorial office: managingeditor@amwa.org. instructions for authors available at: www.amwajournal.org. advertising: contact marketing@amwa.org or (240) 239-0940. all advertising is subject to acceptance by amwa and should be for products and services relevant to professional medical communicators. amwa is not responsible for the content of advertising and does not endorse any advertiser or its products or services. subscription: the amwa journal is published quarterly. subscription is included with amwa membership. nonmember subscriptions cost is $75 per year. contact: american medical writers association, 30 west gude drive, #525, rockville, md 20850-4347. phone: (240) 238-0940; fax: (301) 294-9006; email: amwa@amwa.org. the amwa journal is in the mla international bibliography and selectively indexed in the cumulative index to nursing and allied health literature (cinahl) print index and the cinahl database. the opinions expressed by authors contributing to the journal do not necessarily reflect the opinions of amwa or the institutions with which the authors are affiliated. the association accepts no responsibility for the opinions expressed by contributors to the journal. ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwa journal mission statement in support of the mission of the american medical writers association (amwa) and to advance the broader profession, the amwa journal publishes content that reflects the interests, concerns, and expertise of medical communicators. its purpose is to inform, inspire, and motivate medical communicators. m o re v37 n4 / 2022 44 conscious writing the 5 most commonly misused words in medical writing (according to an editor) � crystal r. herron 46 biography william harold swanberg: radiologist, organizer, and philanthropist � tom lang 52 amwa news from the president � elise eller introducing the 2022–2023 board of directors � elise eller 2022 president’s award recipient: kelly byram, ms, mba, els � katrina r. burton 55 conference 2022 amwa southeast regional conference � susan krug educational sessions • communicating science to the public • jam session for earlyto mid-career freelancers • public relations in medical communication • resources for researching medical devices using publicly available databases • think like an editor: improving document quality for regulatory submissions 62 calendar of meetings contents http://www.amwajournal.org v38 n2 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 47 abstract medical writers are instrumental in developing accredited continuing medical education (cme) for physicians and continuing education (ce) for nurses, pharmacists, and other health professionals. to ensure that cme/ce content meets the learning needs of health professionals, expands knowledge, and builds skills, medical writers should be knowledgeable about adult learning principles and emerging insights from the learning sciences. in this article, i review these principles and describe a suite of practical strategies that medical writers can use to write cme/ce materials that optimize learning. continuing medical education (cme) for physicians and continuing education (ce) for nurses, pharmacists, and other health professionals must meet standards for transparency and integrity as outlined by education accrediting bodies such as the accreditation council for continuing medical education.1 medical writers are instrumental in developing accredited cme/ce materials with integrity for health professionals by ensuring balanced, valid, and unbiased content.2 to ensure that cme/ce content also meets the learning needs of health professionals (otherwise known as learners), expands knowledge, and builds skills, medical writers in the field of cme/ce should be knowledgeable about adult learning principles (alps) and emerging insights from the learning sciences. this knowledge is necessary because incorporating alps into education content is likely to increase the effectiveness of cme/ ce activities and their impact on the behavior of clinicians and patient health outcomes.3 the alliance for continuing education in the health professions, a leading organization that promotes best practices in cme/ce, identifies alps as a core knowledge domain for professionals involved in cme/ce content development. learning frameworks and education formats cme/ce activities help health professionals stay current with the exponentially expanding biomedical and clinical information required to deliver optimal health care.4 however, the relentless accretion of this information can exceed a person’s cognitive capacity—our brains can only absorb a certain amount of information at a time. clinicians compare the experience of staying current with medical sciences and clinical practice updates with “drinking from a firehose.”5 at the same time, health care professionals need more from cme/ce than just information and facts. they also need to learn how to apply that information in clinical settings, exercise analytic and diagnostic skills, and communicate and coordinate with other members of the health care team. to better support knowledge and skills application, the cme/ce field has embraced a lifelong, continuous, competency-based approach to education.6 additionally, interprofessional continuing education (ipce) has emerged as an education framework in which 2 or more professions (eg, nursing, medicine, pharmacy) share a common learning process to learn with, from, and about each other. the goal of ipce is to foster interprofessional communication and teamwork and the effective coordination of patient care.7 ipce differs from multidisciplinary education, which involves health professionals learning separately about patient needs within the context of their own professional roles and responsibilities. modes of education delivery and formats have moved away from didactic lectures toward more interactive and engaging formats that can be delivered online. many health professionals are digital natives and increasingly expect to receive much of their cme/ce via online activities and digital platforms (eg, e-learning modules, webinars, online games, patient simulations). the covid-19 pandemic accelerated this trend toward online learning in accredited cme/ce.8 cme/ce now also measures learning outcomes via distinct frameworks that are sensitive to knowledge uptake, skills acquisition, and changes in clinical practice, performance, and patient outcomes.3,9 moore’s model of outcomes assessment is a commonly used learning and performance outcome framework in cme/ce.9 practical strategies for creating cme/ce content: insights from adult learning scholarship alexandra howson, phd / write medicine, snoqualmie, wa ce craft corner http://www.amwajournal.org amwajournal.org 48practical strategies for creating cme/ce content adult learning principles medical writers involved in developing cme/ce materials for health care professionals need to be able to incorporate alps into content to optimize learning outcomes. alps draw on legacy assumptions from twentieth-century educators and psychologists, including malcolm knowles, john dewey, and others. these educators argued that teaching adults (andragogy) and adult learning differs from teaching children (pedagogy) and childhood learning. as such, adult learning requires a distinct education approach.10 andragogy posits that adult learners learn best when they are self-directed in their approach to learning and intrinsically motivated to learn. intrinsic motivation refers to the interest, pleasure, and satisfaction of learning itself.10 extrinsic motivation refers to outcomes associated with learning (eg, clinical practice demands, improved patient care). in addition, adult learners actively seek learning when they have specific problems to solve and want to immediately apply what they have learned to real-life situations. adult learners also bring a rich reservoir of life experience to the learning process that provides an important context for learning and a foundation for reflection. finally, adult learners learn best when they have control over the timing, nature, and direction of the learning process.10 box 1 summarizes practical applications of alps in cme/ ce writing. insights from adult learning scholarship early twentieth-century adult learning theory focused primarily on differentiating adult learning from learning in childhood. a century later, adult learning scholarship now embraces cognition, memory, and brain structure and function, as well as how sociocultural, professional, and organizational contexts and social/emotional factors (eg, demographics, technology, stress) shape adult learning.10 the learning sciences are multidisciplinary and draw on scholarship from cognitive psychology, sociology, neuroscience, anthropology, behavioral economics, and other academic disciplines.12 what follows is a sampling of insights and strategies from adult learning scholarship that medical writers can use to create cme/ce content that enriches adult learning. cognitive learning theory and science of memory insights what happens in our brains when we are in learning mode? cognitive learning theories focus on the internal dynamics of learning and how people process, structure, and retrieve information. we absorb information via the senses (ie, sensory memory), which is processed in working (ie, short-term) memory and organized into schemas of increasing complexity.13 this processing builds on prior knowledge and is affected by cognitive load, which involves intrinsic load (the volume of information to be processed) and extrinsic load (the work required to process the information). box 2 highlights tactics medical writers can use to manage cognitive load for learners and ease processing. in learning mode, our brains work hard to encode, organize, and consolidate perceptions and experiences so we can retrieve that material in the right context, for the right purpose.13 short-term and long-term memory work together with cues and context so that new information can be integrated with prior knowledge and consolidated or embedded more deeply into our internal archives or memory traces. retrieval practice: before reading the next section, pause for a moment to think about the schemas or ideas you have about adult learning. compare your schemas with the following information. what are the similarities? what are the differences? adult learning principles 1. adult learners are self-directed. 2. learning should be relevant to professional needs or social roles. 3. learning should be problem-oriented and supports the immediate application of knowledge. 4. adult learners appreciate opportunities for feedback and reflection. 5. adult learners prefer control over the timing and direction of learning. practical applications ensure that content is learner-centric, problem-oriented, relevant to practice, based on educational need, and aligned with anticipated outcomes. 1. consult the needs assessment. familiarize yourself with the knowledge/skill needs and the clinical practice/performance gaps presented in the needs assessment. a comprehensive needs assessment will help you understand the clinical gaps and anticipated outcomes that the education is targeting.11 2. identify your audiences. who are the learners? what are their needs? what experience or background do they bring to the educational activity? 3. review the anticipated outcomes. identify the problem that the content needs to address. what do learners need to know or be able to do when they have read the material? 4. apply smarter goals to the content. keep the content specific, measurable, action-oriented, relevant to the learner, learning objectives, and anticipated outcomes, time-specific, evaluable, and realistic. box 1. practical applications of alps in cme/ce writing http://www.amwajournal.org amwajournal.org 49practical strategies for creating cme/ce content forgetting and unlearning are also important in the process of learning new information.13 the multidisciplinary field of learning sciences, as described above, offers many empirically tested strategies that yield deep, durable learning.14 an important principle that brown et al argue in make it stick: the science of successful learning is that interactivity correlates with higher learning impact. the more actively learners engage with educational content, the more likely they are to retrieve and apply information in the appropriate context.13 to this end, instructional designers boost interactivity in e-learning by building effortful and repeated recall, recognition, and retrieval tactics into learning activities.15 similarly, microlearning—delivering short bursts of content that are media-rich and spaced out over time—is thought to boost interactivity and retention by reactivating memory, avoiding cognitive fatigue, and more efficiently moving new information from shortto long-term memory.16 box 2 summarizes tactics medical writers can use to bolster retention and augment interactivity. experiential, emotional, and social learning insights competency-based education and ipce also benefit from insights on the experiential, emotional, and social nature of learning. in experiential learning, experience is considered an important baseline for reflection. put simply, we encounter a problem (a concrete learning event); we take stock of our options for addressing this problem (we reflect); and we actively experiment in designing solutions to the problem (sometimes called “knowing-in-action”).17-18 experiential learning often includes activities that involve self-appraising current practice, identifying a problem in that practice, and problem-based learning as an individual or within in a team. emotional learning is another important consideration in adult learning. working in settings and situations as any kind of clinician is often stressful and, at the very least, can provoke powerful emotions. emotions affect how and what we learn via physiologic responses to situations and subjective experience of that response (ie, mood).14 for instance, when our mood is positive, we are more likely to absorb, retain, and retrieve information (ie, cognitive flexibility). we are more likely to see the bigger picture and apply new information to practice. role play is an example of a cme/ ce activity that might be used to explore how emotional states can impact both clinical practice and learning. emotional learning is grounded in social cognitive theory, which suggests that we learn more effectively when we are observing and interacting with others.19 social learning occurs when we belong to a community of learners or a community of practice. communities of practice are often self-organized and emphasize participation and collaboration as the key drivers of learning. examples of cme/ce that optimize communities of practice include journal clubs and discussions via social media groups. in competency-based education for health professionals, learners also need to be able to develop expertise and progress from novice to mastery levels of competence. the trajectory toward mastery requires deliberate practice, a key ingredient in information processing and skills acquisition that involves effort, repetition, and feedback.20 deliberate practice is a common characteristic of virtual simulations or caseand vignette-based activities. cases and vignettes are designed to mirror real-world challenges in health care and enable learners to practice reasoning, communication, and procedural skills. in online environments, patient cases are often highly interactive and are accompanied by feedback that offers insight into the consequences of learner choices, guides the learner toward an end goal, and allows room for failure and course corrections.20-21 examples of written feedback include expert or virtual patient commentary or notes about clinical outcomes that occurred because of decisions the learner made in the activity. box 3 highlights tactics medical writers can use to incorporate experiential, emotional, and social learning insights into the development of cme/ce activities. conclusion cme/ce continues to grow as a field and as a market for medical writers. market forecasts project a 5.9% growth ($2,715.22 million to $3,830.46 million) between 2022 and 2027.22 health professionals are required to earn cme/ce credits as part of maintaining their professional licenses • stay on track. ensure that written content addresses the learning objectives. • edit ruthlessly. reduce distractions and eliminate extraneous information. • be bold. highlight essential points for the learner. • build iteratively. sequence the presentation of ideas from simple to more complex. • parse it out. chunk complex ideas into bite-sized portions of text. • pair image with text. embed images, graphics, audio, or video clips to text where appropriate. • offer opportunities for retrieval practice. include questions to encourage long-term memory retrieval and help learner connect new information with prior knowledge. • promote active discovery. include exercises or activities such as matching, polling, or multiple-choice questions to help learners identify gaps between what they thought they knew and what they ought to know. box 2. practical applications of cognitive learning theory and science of memory in cme/ce writing http://www.amwajournal.org amwajournal.org 50practical strategies for creating cme/ce content but are extremely busy, and their in-the-moment learning capacity is affected by many factors, including specialty, proficiency level, and workplace setting. our goal as cme/ ce writers is to help health professionals process, synthesize, and apply new information effectively in the relevant context. we can help to move learners from what they know and can already do toward what they need to know and apply in practice by using alp strategies to guide content development. acknowledgments thanks to haifa kassis, md, and crystal r. herron, phd, for the review of and recommendations for the manuscript. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: alex@alexhowson.com references 1. accreditation council for continuing medical education. standards for integrity and independence in accredited continuing education. accreditation council for continuing medical education, 2020. accessed january 6, 2023. https:// accme.org/publications/standards-for-integrity-andindependence-accredited-continuing-education-pdf 2. bowser a. avoiding bias and ensuring content validity in accredited continuing education: what do the latest accme standards mean for medical writers? amwa j. 2022;37(3):11-15. 3. cervero rm, gaines jm. the impact of cme on physician performance and patient health outcomes: an updated synthesis of systematic reviews. j contin educ health prof. 2015;35(2):131-138. 4. lucey cr. medical education: part of the problem and part of the solution. jama intern med. 2013;173(17):1639-1643. 5. dunn c, gately l, gibbs p. drinking from the firehose – a clinician's perspective on the challenges of delivering biomarkerdriven care in routine practice. eur j cancer. 2021;157:301-305. 6. balmer jt. the transformation of continuing medical education (cme) in the united states. adv med educ pract. 2013;4:171-182. 7. reeves s, fletcher s, barr h, et al. a beme systematic review of the effects of interprofessional education: beme guide no. 39. med teach. 2016; 38(7):656-668. 8. accreditation council for continuing medical education. accme data report onward and upward: thriving together in accredited continuing medical education – 2021. accreditation council for continuing medical education, 2022. accessed january 6, 2023. https://accme.org/sites/default/files/2022-10/2021%20 accme%20data%20report_967_20221005.pdf 9. moore de jr, green js, gallis ha. achieving desired results and improved outcomes: integrating planning and assessment throughout learning activities. j contin educ health prof. 2009; 29(1):1-15 10. merriam sb, baumgartner lm. learning in adulthood: a comprehensive guide. 4th ed. jossey-bass; 2020. 11. parry nma. the needs assessment in continuing medical education. med writ. 2014; 23(2):125-128. 12. wlodarczyk s, dhaliwal g. the learning sciences meet the learning health system. jama netw open. 2022;5(7):e2223113. 13. brown pc, roediger hl iii, mcdaniel ma. make it stick: the science of successful learning. belknap press; 2014. 14. gooding hc, mann k, armstrong e. twelve tips for applying the science of learning to health professions education. med teach. 2017; 39(1):26-31. 15. dirksen j. design for how people learn. 2nd ed. new riders; 2016. 16. shail ms. using micro-learning on mobile applications to increase knowledge retention and work performance: a review of the literature. cureus. 2019;11(8):e5307. 17. kolb da. experiential learning: experience as the source of learning and development. 2nd ed. pearson education inc.; 2014. 18. schön da. educating the reflective practitioner: toward a new design for teaching and learning in the professions. 1st ed. josseybass; 1987. 19. bandura a. human agency in social cognitive theory. am psych. 1989;44(9):1175-1184. 20. ericsson ka. acquisition and maintenance of medical expertise: a perspective from the expert-performance approach with deliberate practice. acad med. 2015;90(11):1471-1486. 21. richards ps, inglehart mr. an interdisciplinary approach to casebased teaching: does it create patient-centered and culturally sensitive providers? j dent educ. 2006;70(3):284-291. 22. research and markets. u.s. continuing medical education market industry outlook & forecast 2022-2027. research and markets website. published february 2022. accessed january 6, 2023. https://www.researchandmarkets.com/reports/5544417/u-scontinuing-medical-education-market?gclid=cj0kcqjwrs2xbhdj arisahvymmrpk5kmdzfrcdu9hvg8dvbxin5hy456ee0g0rtzt lyamu_oxvvmxhmaajw6ealw_wcb • build reflection into the text. use open-ended or polling questions to encourage learners/readers to actively think about how to apply the presented information to clinical practice. • flex your metaphor muscles. metaphors can help learners integrate new information into clinical practice. • emphasize context. where possible, describe the clinical, professional, and organizational context in which learners are expected to apply new information or skills. this helps to situate learning in relationships and communities of practice. • use storytelling to engage learners. a story-based approach to content through patient cases or vignettes promotes clinical problem-solving and deliberate practice. storytelling also establishes learner empathy with patient experience. • deliver concrete, constructive feedback. feedback delivered in small, digestible chunks diffuses defensiveness, minimizes negative emotional responses, and reduces cognitive load.21 box 3. practical applications of experiential, emotional, and social learning insights in cme/ce writing http://www.amwajournal.org https://accme.org/publications/standards-for-integrity-and-independence-accredited-continuing-education-pdf https://accme.org/publications/standards-for-integrity-and-independence-accredited-continuing-education-pdf https://accme.org/publications/standards-for-integrity-and-independence-accredited-continuing-education-pdf https://accme.org/sites/default/files/2022-10/2021%20accme%20data%20report_967_20221005.pdf https://accme.org/sites/default/files/2022-10/2021%20accme%20data%20report_967_20221005.pdf https://www.researchandmarkets.com/reports/5544417/u-s-continuing-medical-education-market?gclid=cj0kcqjwrs2xbhdjarisahvymmrpk5kmdzfrcdu9hvg8dvbxin5hy456ee0g0rtztlyamu_oxvvmxhmaajw6ealw_wcb https://www.researchandmarkets.com/reports/5544417/u-s-continuing-medical-education-market?gclid=cj0kcqjwrs2xbhdjarisahvymmrpk5kmdzfrcdu9hvg8dvbxin5hy456ee0g0rtztlyamu_oxvvmxhmaajw6ealw_wcb https://www.researchandmarkets.com/reports/5544417/u-s-continuing-medical-education-market?gclid=cj0kcqjwrs2xbhdjarisahvymmrpk5kmdzfrcdu9hvg8dvbxin5hy456ee0g0rtztlyamu_oxvvmxhmaajw6ealw_wcb https://www.researchandmarkets.com/reports/5544417/u-s-continuing-medical-education-market?gclid=cj0kcqjwrs2xbhdjarisahvymmrpk5kmdzfrcdu9hvg8dvbxin5hy456ee0g0rtztlyamu_oxvvmxhmaajw6ealw_wcb v38 n2 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 28 abstract antibody-drug conjugates (adcs) are currently among the fastest growing drug classes in oncology, combining the specificity and targeting capabilities of monoclonal antibodies (mabs) with the potent cytotoxicity of small molecule drugs. considered the “biological missiles” of cancer therapy, adcs are composed of 3 key elements: (1) a mab framework that selectively binds to an antigen on the tumor cell surface, (2) a cytotoxic drug payload, and (3) a chemical linker attaching the 2 entities. because each of these components can vary widely among adcs, the associated drug design is relatively complex, with subtle differences leading to immense diversity in the overall drug structure and associated pharmacological and clinical properties. as medical communication experts, it is essential to have a basic understanding of the various components of adc design and their potential impact on drug efficacy, safety, and capability in targeting certain degrees of antigen expression and tumor types. this review aims to provide a basic understanding of each component related to adc design and the role they play in defining the pharmacological properties of a particular adc. background first proposed by paul ehrlich in the early 1900s, the foundational concept of a “magic bullet” as a way to selectively transport cytotoxic drugs to a specific target tissue has become an ever-closer reality, passing through key milestones over the last century.1,2 the development of chemotherapy in the 1940s was a first major step in the transition from concept to reality.3 however, the lack of high-level specificity and targeting capabilities with cytotoxic agents led to a high degree of systemic toxicities and has remained an ongoing challenge. the advent of hybridoma technology and the development of monoclonal antibodies (mabs) in the 1970s established a highly effective method for targeting specific antigens expressed on the tumor cell surface.1,4,5 this led to the development of targeted therapeutics that have become an attractive method for improving tumor selectivity and reducing the systemic toxicity associated with traditional chemotherapy.6 combining these 2 technologies enabled the development of the first antibody-drug conjugate (adc). in recent decades, adcs have become a rapidly expanding therapeutic drug class specifically designed to overcome the shortfalls associated with chemotherapeutic agents.6,7 currently, there are 13 adcs that have received us food and drug administration approval for various hematological and solid tumor cancers.1,8-20 adc mechanism of action adcs are a group of tripartite drugs made up of a tumor specific mab conjugated via a stable linker to a potent cytotoxic payload.21,22 the core concept of an adc is to use the specific recognition between an antibody and antigen to selectively deliver cytotoxic drugs to the tumor site, after which the payload is released in the tumor via a specific release mechanism.23 the general mechanism of action for an adc can vary depending on the inherent design (figure 1, next page). adc design the clinical success achieved with a particular adc is contingent upon several key factors: (1) target antigen, (2) antibody framework, (3) method of conjugation, (4) chemical linker, and (5) cytotoxic payload (table 1, next page). target antigen to achieve a favorable therapeutic index and reduce the potential for off-target toxicity, the selected target antigen should be tumor-specific or tumor-associated with a high level of expression in tumor cells and minimal to no expression in healthy tissues.24,28 following adc binding, target antigens should internalize efficiently via endocytosis to enable adc entry into the cell and subsequent cellular transport and payload release.1,21,29 the target antigen should also undergo efficient recycling or replenishment on the cell surface with no associated antigen shedding into jason r. lewis, pharmd, ms, mba, bcacp / lrx precision health consulting and medical communication services, nephi, ut antibody-drug conjugates: understanding associated drug design and pharmacology science series http://www.amwajournal.org amwajournal.org 29antibody-drug conjugates figure 1. general mechanism of action of adcs with and without bystander killing effect.5,21-23 following introduction of the antibody-drug conjugate (adc) into the plasma circulation by intravenous injection, the target antigen is recognized on the tumor cell surface, leading to subsequent binding and formation of an antigen–adc complex (adcc). the complex is then internalized via receptor-mediated endocytosis. for adcs with cleavable linker design, some initial release of drug payload may occur prior to internalization. once inside the cytosol, endosome, or lysosome, the chemical characteristics of these environments (eg, low ph, high glutathione/thiol levels, proteolytic enzymes) allow for further payload release. in the case of adcs with noncleavable linker design, compete degradation of the adc is typically required for payload release. the resulting free cytotoxic drug payload then exerts its cellular destruction via a pathway-specific mechanism (eg, microtubule disruption, dna intercalation). hydrophobic or nonpolar payloads are capable of crossing cell membranes, thereby exerting a so-called bystander effect. the bystander killing effect involves the diffusion of free drug across cell membranes from the target tumor cell and into neighboring tumor cells, thereby expanding antitumor activity to tumor cells with low or no target antigen expression, or those that are less accessible directly from the circulatory system, eg, solid tumor cells. ag, antigen. table 1. components of adc drug design1,7,25,26table 1. components of adc drug design1,7,25,26 target antigen antibody framework method of conjugation chemical linker cytotoxic payload ideal characteristics • highly expressed in tumor cells • homogeneous expression in tumor cells • minimal presence in circulation and healthy cells ideal characteristics • minimal cross reactivity with healthy tissues • low immunogenicity • strong binding affinity for the target antigen • long pk half-life conventional/stochastic • lysine sites • reduced cysteine sites site-specific • engineered reactive cysteine residues • disulfide re-bridging • unnatural amino acids • enzyme assisted ligation • glycan remodeling and glycoconjugation • pclick technology cleavable linkers chemically cleavable • acid sensitive • glutathione sensitive enzymatically cleavable • peptide based (protease sensitive) • β-glucuronide based • phosphate based noncleavable linkers • thioether (smcc) • maleimido propionyl • maleimido caproyl tubulin inhibitors • auristatins (eg, mmae, mmaf) • maytansinoids (eg, dm1, dm4) • tubulysins (eg, tubulysin a) dna damaging agents • calicheamicins (eg, ozogamicin) • duocarmycins (eg, duocarmazine) • pyrrolbenzodiazepines • camptothecin analogues (eg, govitecan, dxd) immunomodulators • tlr agonists • sting agonists abbreviations: ag, antigen; dm1, mertansine; dm4, ravtansine; dxd, deruxtecan; fab, fragment antigen binding; fc, fragment crystallized; mmae, monomethyl auristatin e; mmaf, monomethyl auristatin f; pk, pharmacokinetic; smcc, sulfosuccinimidyl 4-(n-maleimidomethyl)cyclohexane-1-carbocylate; sting, stimulator of interferon genes; tlr, toll-like receptor. http://www.amwajournal.org amwajournal.org 30antibody-drug conjugates circulation to improve tumor cell targeting and reduce the risk of toxicity.30,31 solid tumors present a challenge in terms of both the drug accessibility and intratumoral heterogeneity of the target antigen. therefore, certain characteristics of adc design, such as cleavable linkers or nonpolarized payloads, which permit the release or distribution of drug to neighboring tumor cells with low or no antigen expression (the so-called bystander effect), may be advantageous in adcs targeting these tumor types.31 antibody framework the antibody framework used in the adc structure is essential for facilitating selective binding of target antigens and can significantly influence the overall efficacy, therapeutic index, and pharmacokinetic and pharmacodynamic characteristics of the end drug product.1,21 ideally, the selected mab should possess a strong binding affinity with high target specificity and minimal cross-reactivity with healthy tissues.24 the selected mab should also facilitate efficient internalization, demonstrate low immunogenicity, and have a long half-life. among the 5 major subtypes of human antibodies (eg, immunoglobulin [ig]a, igd, ige, igg, and igm), igg antibodies are most often used for adc development because of their plasma stability and strong binding affinity for the fragment crystallized (fc) receptor.1,21,32 moreover, because of their decreased potential for immunogenicity, humanized or fully human mabs are typically favored in adc design as opposed to murine or chimeric mabs. method of conjugation: conventional the method of conjugation in adc design refers to the approach used to connect the linker and payload to the mab framework.1 historically, conventional conjugation methods have been the most widely used in adc design. conventional conjugation entails either the alkylation or acylation of lysine side chains or the reduction of disulfide bonds to liberate cysteine residues for conjugation sites.21,33 notably, mabs such as igg contain a natural abundance of lysine (80-100) and cysteine (32-40) residues, which offer ideal sites for linker attachment via conventional conjugation involving coupling reactions.1,27,33-36 conventional conjugation using lysine and cysteine residues is stochastic. this can lead to heterogeneous mixtures of adc species with varying sites of conjugation and drug-to-antibody ratios (dars), defined as the number of drug payloads conjugated to each mab.37 dars associated with adcs produced by conventional conjugation methods often vary, ranging from 0 to 8 or more.38 dar-associated variability can potentially impact certain adc characteristics, such as hydrophobicity, charge, polarity, pharmacokinetics, and thermostability of mabs.38-40 in some cases this may result in insufficient stability, causing premature payload release and increased potential for off-target toxicities.1 elevated dars can also lead to aggregation, increased metabolism, or disruptive coupling within the antigen binding region of the mab.21,41,42 because lysine residues are distributed throughout both heavy and light chain regions of the antibody, coupling reactions resulting in payload conjugation near antibody–antigen recognition sites could interfere with adc target binding.1,39 moreover, adcs with cytotoxic payloads conjugated to heavy chain regions of the mab have lower in vivo efficacy compared with light chain conjugates.24,44 consequently, novel site-specific conjugation strategies have been developed that produce more homogeneous adc products with favorable pharmacokinetic and antigen binding properties.1,37,41 method of conjugation: site-specific site-specific conjugation strategies are categorized according to their associated methodology and generally include the following: (1) engineered cysteine residues, (2) disulfide rebridging, (3) engineered unnatural amino acids, (4) enzymatic assisted ligation (5) glycan remodeling/glycoconjugation, and (6) proximity-induced antibody conjugation method (pclick) technology.1,21,45,46 site-specific cysteine residues are commonly engineered using thiomab technology, which allows specific positioning of conjugation sites within both heavy chain and light chain regions of the antibody.47 drug conjugates created using thiomab technology are typically referred to as thiomab-drug conjugates and are shown to have improved safety and therapeutic indexes.46 disulfide rebridging is a process in which 4 interchain disulfide bonds in an igg antibody are reduced and subsequently treated with a cysteine-selective cross-linking reagent.48 this rebridging process enables simultaneous reattachment of polypeptide chain and installation of drug molecules or function groups that may be further modified. genetically encoded unnatural amino acids, such as p-acetylphenylalanine and p-azidophenylalanine, are other site-specific conjugation methods that have demonstrated specific advantages in terms of optimizing physical properties of the adc, and improved associated efficacy, pharmacokinetic, and safety profiles.41,49 compared with conventional cysteine conjugated adcs, those using unnatural amino acids for site-specific conjugation demonstrate superior in vitro selectivity and efficacy, particularly in low antigen expressing tumor cells.50 enzyme-assisted ligation techniques use enzymes such as transglutaminase to conjugate specific amino acid sequences or tags that are genetically engineered and artificially induced to express in the antibody.1,21,51 glycan remodeling or glycoconjugahttp://www.amwajournal.org amwajournal.org 31antibody-drug conjugates tion methods exploit naturally-occurring glycosylation sites at the n297 residue in the ch2 domain of igg antibodies.52 however, relative to other site-specific conjugation approaches, glycan remodeling has limited control over site placement. a site-selective conjugation method using pclick has more recently emerged and uses a proximity activated crosslinker to covalently attach to a specific antibody site, which eliminates the need for additional antibody engineering or post-synthesis treatments.53 chemical linker the primary function of chemical linkers in adc design is to effectively bridge the mab to the cytotoxic drug payload.1 adc specificity, potency, safety, and overall activity are greatly influenced by the associated linker chemistry.24 linkers are generally designed to remain stable in circulation and release the drug payload once the adc has reached the target tumor site.2,24 chemical linkers commonly employed in adc design are classified into 2 main categories: cleavable and noncleavable linkers.1,24 cleavable linkers cleavable linkers are designed to exploit cancer-specific cellular conditions and are generally divided into 3 primary categories: acid or ph sensitive, glutathione or redox sensitive, and enzymatically cleavable (eg, protease sensitive).21,24,28 acid-sensitive linkers, such as hydrazone, are designed to release the drug payload within acidic environments, such as lysosomal or endosomal cellular compartments, while remaining stable within the blood’s neutral ph environment.1,31 glutathione-sensitive or disulfide linkers exploit the high levels of glutathione and other thiols present in the cytosol of cancer cells, thereby enabling selective cleavage of the cytotoxic payload at the tumor site.24,28,54 protease sensitive or peptide-based linkers most often consist of dipeptide linkers (eg, valine-citrulline), which require enzymatic cleavage of peptide bonds for payload release.28,31,55 compared with chemically liable linkers (eg, hydrazone and disulfide), peptide-based linker technologies allow for greater control of drug delivery, with improved systemic stability and rapid enzyme-mediated release of the drug payload within the target cell.31 noncleavable linkers in contrast with cleavable linkers that rely on tumor-specific cellular conditions for payload release, noncleavable linkers require internalization via antigen-mediated endocytosis and lysosome-mediated proteolytic degradation for payload release.24,31,56 generally, noncleavable linkers are associated with greater plasma stability, longer half-lives, and pose a reduced risk for off-target side effects. however, the actions of adcs with noncleavable links are typically restricted to the target tumor cell. moreover, amino acid-drug metabolites resulting from the drug payload release tend to be more hydrophilic and have greater intrinsic polarity, which reduces bystander effect. commonly used noncleavable linkers in adc design include the thioether linker succinimidyl-4-(n-maleimidomethyl) cyclohexane-1-carboxylate or maleimide moieties, such as maleimdopropionyl and maleimdocaproyl.25 cytotoxic drug payload the drug payloads employed in the design of adcs are typically 100 to 1,000 times more potent than the cytotoxic agents used in traditional chemotherapy.24,57 cytotoxic payloads are generally subdivided into 2 main categories: (1) dna-damaging agents, including calicheamicins, duocarmycins, pyrrolobenzodiazepines and camptothecin analogues; and (2) anti-tubulin agents, including auristatins, maytansinoids, and tubulysins.1,24,28 calicheamicins (eg, ozogamicin) were first isolated from the actinomycete micromonospora echinospora in the mid1980s, and act by binding the minor groove of dna, causing site-specific, double-stranded dna breaks.31,58-60 notably, calicheamicins are highly hydrophobic, which limits the dar or number of payload molecules able to be attached per mab. duocarmycins are potent alkylating compounds derived from the bacteria species streptomyces zelensis. duocarmycin and its derivatives, such as duocarmazine, act by binding to and alkylating adenine within the minor groove of dna, leading to subsequent dna strand cleavage and cellular apoptosis.61-64 pyrrolobenzodiazepine (pbd) dimers, such as tesirine, are dna-damaging agents derived from anthramycin, an antitumor antibiotic isolated from streptomyces.65-68 pbd dimers bind the dna minor groove, forming covalent interstrand dna crosslinks within tumor cells that lead to cytotoxicity and cell death.28,69,70 the formation of crosslinks resulting from pbd activity, which occurs rapidly and with minimal dna distortion, is thought to contribute to their persistence and evasion of dna repair mechanisms. campothecin is a pentacyclic alkaloid isolated from the stem wood of camototheca acuminata, a tree indigenous to china.71-73 campothecin and its derivatives (eg, govitecan, deruxtecan) act by inhibiting topoisomerase i enzyme activity, which results in double-stranded dna breaks and subsequent cell death.72-75 auristatins commonly used as adc payloads include monomethyl auristatin e and monomethyl auristatin f, which are both synthetic analogues of dolastatin 10, a naturally-occurring antimitotic drug isolated from the sea hare dolabella auricularia.28,76,77 auristatins inhibit tubulin polymerization by attaching to the same binding site as vinca alkahttp://www.amwajournal.org amwajournal.org 32antibody-drug conjugates loids (eg, vincristine, vinblastine), which are frequently used as traditional chemotherapy agents.78-80 maytansinoids are benzoansamacrolides derived from the bark of an african shrub, maytenus ovatus.81 similar to auristatins, maytansinoids bind at or near the vinca-binding site, thereby inhibiting microtubule assembly and inducing mitotic arrest.31,82 maytansinoids commonly used in adc design include 2 thiomethyl derivatives of maytansine: mertansine and ravtansine.1,31,83 tubulysins comprise a family of more recently discovered cytostatic peptides isolated from the myxobacteria species, archangium gephyra and angiococcus disciformis, that act by inhibiting microtubule polymerization during mitosis, thereby inducing apoptosis.28,84,85 discussion rapid advances in molecular and genomic technologies over the last several decades have ushered in a new era of precision medicine and led to the increased use of these technologies as important clinical tools for the diagnosis, classification, and treatment of disease.86 as the use of precision-based treatment strategies has expanded, biomarker testing has become an increasingly important prognostic and predictive tool to improve disease management and enabled the development of numerous targeted therapies.88,89 the effect of precision-based approaches on the treatment landscape has been especially profound in the oncology space, as reflected the growing number of biomarker-driven clinical trials, which increased from 15% in 2000 to 55% in 2018.89 although targeted therapies have led to major improvements in progression-free and overall survival, acquired drug resistance has led to associated therapeutic limitations and the need for other treatment options.86 adcs in particular represent a unique treatment approach that combines precision-based technology used in targeted therapy approaches with chemotherapy-based strategies using cytotoxic agents with greater potency. since the approval of the first adc in 2000, continued technological advancements have led to an explosion in the number of adcs under clinical development over the last few decades. as of 2022, a total of 12 adcs with 9 associated biomarker targets have been approved for use in the treatment of both solid tumor and hematological malignancies.7,90 in addition, over 80 adcs are currently being evaluated in clinical trials, suggesting that utilization of these novel agents will continue to increase. most recently, the clinical development of novel adcs has had a profound impact on the treatment landscape for solid tumors. the destiny series of clinical trials, investigated the human epidermal growth factor receptor 2 (her2)-directed adc, trastuzumab deruxtecan (t-dxd) in a number of solid tumor types.91 resulting data from these trials, led to approved indications in her2-positive metastatic breast cancer (mbc), her2-low mbc, and gastric or gastroesophageal cancer, as well as accelerated approval in non-small cell lung cancer.16,92-95 notably, destiny trial data surrounding t-dxd in mbc were not only unprecedented, but also transformative, and have played a major in reshaping how her2 expression in tumors is assessed and managed. historically, her2 expression assessed via immunohistochemistry methods has been associated with a binary classification, namely her2-positive or her2negative.96 early targeted therapies directed toward the her2 receptor only demonstrated efficacy in her2-positive mbc, with no effect in those with her2-negative status.96 however, the unique adc design associated with t-dxd and the resulting bystander effect have expanded observed therapeutic responses to patients with lower levels of her2 expression.97 conclusion as the incidence of cancer increases worldwide, growing demand for safer, more personalized cancer therapies with fewer side effects will undoubtedly propel further advances in adc technology. over the last 5 years alone, 39 clinical trials have investigated over 19 adcs.98,99 given the pace at which adc therapeutics are being introduced, the need for clear and accurate communication of information regarding these sophisticated treatments will also continue to grow. we as medical communicators must make it our mission to educate ourselves and our readers so that they can approach the literature critically and make informed decisions about their use. acknowledgments we thank yuqian lu, ma, for her design of the accompanying figure and table. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: lrxprecsionhealth@gmail.com references 1. fu z, li s, han s, shi c, zhang y. antibody drug conjugate: the “biological missile” for targeted cancer therapy. signal transduct target ther. 2022;7(1):93. doi:10.1038/s41392-022-00947-7 2. feld j, barta sk, schinke c, braunschweig i, zhou y, verma ak. linked-in: design and efficacy of antibody drug conjugates in oncology. oncotarget. 2013;4(3):397-412. doi: 10.18632/ oncotarget.924 3. devita vt jr, chu e. a history of cancer chemotherapy. cancer res. 2008;68(21):8643-8653. doi:10.1158/0008-5472.can-07-6611 4. köhler g, milstein c. continuous cultures of fused cells secreting antibody of predefined specificity. nature. 1975;256(5517):495497. 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doi:10.3390/cancers13051015 97. modi s, jacot w, yamashita t, et al. trastuzumab deruxtecan in previously treated her2-low advanced breast cancer. n engl j med. 2022;387(1):9-20. doi:10.1056/nejmoa2203690 98. abuhelwa z, alloghbi a, nagasaka m. a comprehensive review on antibody-drug conjugates (adcs) in the treatment landscape of non-small cell lung cancer (nsclc). cancer treat rev. 2022;106:102393. doi:10.1016/j.ctrv.2022.102393 99. mullin r. new day for antibody-drug conjugates. chemical & engineering news. may 15, 2022. accessed november 23, 2022. https://cen.acs.org/pharmaceuticals/biologics/new-dayantibody-drug-conjugates/100/i17 general principles of word usage www.amwa.org/online_learning choose the right word for accuracy and clarity. http://www.amwajournal.org http://www.personalizedmedicinecoalition.org/userfiles/pmc-corporate/file/the_evolution_of_biomarker_use_in_clinical_trials_for_cancer_treatments.pdf http://www.personalizedmedicinecoalition.org/userfiles/pmc-corporate/file/the_evolution_of_biomarker_use_in_clinical_trials_for_cancer_treatments.pdf http://www.personalizedmedicinecoalition.org/userfiles/pmc-corporate/file/the_evolution_of_biomarker_use_in_clinical_trials_for_cancer_treatments.pdf https://www.biochempeg.com/article/74.html https://www.destinyclinicaltrials.com/en https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-fam-trastuzumab-deruxtecan-nxki-breast-cancer https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-fam-trastuzumab-deruxtecan-nxki-breast-cancer https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-fam-trastuzumab-deruxtecan-nxki-breast-cancer https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-her2-positive-gastric-adenocarcinomas https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-her2-positive-gastric-adenocarcinomas https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-her2-positive-gastric-adenocarcinomas https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-fam-trastuzumab-deruxtecan-nxki-her2-mutant-non-small-cell-lung https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-fam-trastuzumab-deruxtecan-nxki-her2-mutant-non-small-cell-lung https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-fam-trastuzumab-deruxtecan-nxki-her2-mutant-non-small-cell-lung https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-fam-trastuzumab-deruxtecan-nxki-her2-mutant-non-small-cell-lung https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-her2-low-breast-cancer https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-her2-low-breast-cancer https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-her2-low-breast-cancer https://cen.acs.org/pharmaceuticals/biologics/new-day-antibody-drug-conjugates/100/i17 https://cen.acs.org/pharmaceuticals/biologics/new-day-antibody-drug-conjugates/100/i17 v37 n3 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 32 diversity, equity, and inclusion (dei) is a phrase that refers to organizational principles and policies that promote inclusion and representation of diverse people, including individuals of different ages, genders, races and ethnicities, religions, cultures, sexual orientations, and abilities. the amwa leadership is 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the interest, participation, and leadership of underrepresented groups within our organization. • cultivate an inclusive, diverse, and accessible community of medical communicators. a second outcome of amwa’s dei initiative was the creation and engagement of a diversity & inclusion assessment task force that developed the 2022 amwa dei survey. the survey launched in august, and results will help amwa gain a clearer understanding of the existing diversity of our membership, learn about current challenges or shortcomings, and recognize what amwa is doing well so that we can continue to build upon that foundation. by leveraging the welcoming culture of amwa, we hope to create an even more inclusive, diverse, and collaborative environment for all. it is important that we demonstrate our commitment to diversity, equality, and inclusion to our members and staff as well as the medical communication community at large. as medical communicators, our members play a crucial part in ensuring that information about health, medicine, and science is communicated accurately and clearly to help a variety of audiences make important health-related decisions. amwa previously issued a statement in june 2020 (https://www.amwa.org/news/511877/a-message-fromthe-amwa-president-and-executive-director.htm) on the effects of systemic racism and inherent bias that have led to health disparities that adversely and disproportionately affect minority groups. the statement acknowledged that health and well-being for all cannot exist alongside endemic racial health inequities. the message also emphasized that diversity is a strength that enriches the amwa membership. these are just the first steps that amwa will take as it continues to address dei needs. we are proud of our warm and welcoming community and the diversity among our regional and national leaders; however, there is always room for improvement. as we move forward, we plan to ensure that our programs, policies, and practices are fair and equitable for all among our diverse membership. we look forward to implementing enhancements throughout the organization that will align our commitment to dei with our overall mission as we aspire to maintain a welcoming environment that celebrates differences and where people of different backgrounds feel comfortable sharing diverse, mission-advancing perspectives. susan krug, ms, cae / amwa executive director the american medical writers association (amwa) announces new diversity, equity, and inclusion statement amwa news http://www.amwajournal.org https://www.amwa.org/news/511877/a-message-from-the-amwa-president-and-executive-director.htm https://www.amwa.org/news/511877/a-message-from-the-amwa-president-and-executive-director.htm v37 n4 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 53 the amwa board of directors (bod) is our organization’s governing body. as stated in article iii in the amwa bylaws, the bod manages and controls the affairs, property, and business of amwa. the bod meets consistently throughout the year to discuss and take action on items as they pertain to the organization. the bod is responsible for approving the budget, the slate of nominees for elected office, and any proposed amendments to the constitution or bylaws. it also approves committees, work groups, and task forces and fulfills such other duties as are specifically mentioned in the constitution and bylaws and as required by law. the bod has the right to empower the executive committee, consisting of the president, president-elect, secretary, treasurer, immediate past president, and executive director, to act in between full bod meetings. in alignment with amwa bylaws, the bod shall include elected officers, an executive director, a chair of the chapter advisory council, and at least 5 appointed at-large directors. the number of members on the bod during the governance year shall be no less than 12 and no more than 17. the full scope of the bod’s responsibilities can be found in article iii of the bylaws of the american medical writers association. i am pleased to introduce the 2022-2023 bod, which consists of at-large directors, the chair of the chapter advisory council, and officers. awma strives to have a bod that is representative of our organization’s membership, reflecting characteristics of the member population. at its september 2022 meeting, the bod approved the following individuals to serve as at-large directors for the 2022-2023 term: • joan affleck, mba, els • loretta bohn, ba, els • sarah dobney, mph • lynne munno, ma, ms • joanna pendergrass, dvm • genevieve walker, phd • shawn watson, pharmd, phd, bcps the bod also approved the chair of the chapter advisory council (a voting member of the bod): • jennifer minarcik, ms amwa 2022-2023 officers: • president: elise eller, phd • president-elect: r. michelle sauer gehring, phd, els • secretary: kimberly korwek, phd • treasurer: julie phelan, md, mba • immediate past president: katrina r. burton, bs • amwa executive director: susan krug, ms, cae (ex officio, nonvoting) the 2022-2023 bod began its service on november 5, 2022 at the conclusion of the 2022 annual business meeting at the 2022 medical writing & communication conference in denver, colorado. elise eller, phd / 2022–2023 amwa president introducing the 2022–2023 board of directors amwa news http://www.amwajournal.org v38 n1 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 62 save the dates, october 25 through 28, to join us in baltimore, maryland, for the 2023 medical writing & communication conference. we’ll be at the baltimore marriott waterfront hotel, a spectacular location on — as its name says — the waterfront. we’re looking forward to seeing you in person at #amwa2023, your home for continuous learning and connection in the field of medical communication. amwa is committed to furthering the skills and knowledge of professional medical communicators. amwa’s medical writing & communication conference is the go-to event for our profession and focuses on trends and opportunities in medical communication. it’s the premier place to find educational, professional, and networking opportunities. the annual conference committee has been working hard to develop a conference program that will appeal to the needs of our diverse members. program topics cover professional focus areas such as regulatory writing, promotional writing, medical editing, scientific publications, and health communication. we’re also including topics in career development; core knowledge and skills, such as science and medicine; writing and editing mechanics; technology; and work/life balance. we have aimed to include trendsetting topics such as data visualization, patient decision aids, plain language summaries of publications, and structured authoring. and we’ve worked hard to cover topics at a range of levels from beginning to mid-career to experienced medical communicators. as in past years, the medical writing & communication conference will offer a variety of formats for learning and networking with peers. we’ll offer the highly regarded amwa workshops for additional fees for those who wish to learn specific topics in depth. and the conference will feature medwrite talks, jam sessions, speaker sessions, roundtables, and poster and networking time to keep you refreshed and active. the city of baltimore offers a wonderful array of old and new, familiar and exotic. i encourage you to schedule your travel to take advantage of the city’s unique culture. sample local seafood; view the skyline from a harbor cruise or water taxi; or visit the maryland science center, the national aquarium, or the historic ships in the inner harbor. if you’re a history buff, plan a trip to fort mchenry at baltimore’s locust point; it’s the site of the battle of baltimore that inspired francis scott key to write “the starspangled banner.” for me, personally, it’s been more than 3 decades since i last visited, and i am looking forward to absorbing the vibe of charm city again. baltimore is very close to amwa’s executive offices in rockville, maryland, hence the idea of “homecoming” for this year’s conference. in a time of rapid change and development of our profession, it’s a great vantage point from which to look to the future. stay tuned for conference registration information. i look forward to seeing you in baltimore in october! michele w. sequeira, ms, mba, mwc / chair, annual conference program committee conference preview: homecoming in baltimore amwa news #amwa2023 october 25–28 p ho to b y b re n da n b ea le o n u n sp la sh http://www.amwajournal.org v38 n2 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 43 abstract continuing education (ce) writing is a major field of work for medical writers and editors. to effectively write and edit ce materials, medical writers need to understand the target clinician audience, including clinical responsibilities. physicians, nurse practitioners, physician assistants, pharmacists, nurses, clinical psychologists, and dieticians are examples of professions that often require ce to maintain licensure. with a general trend of increased funding for ce programs, medical writers and editors have opportunities to be involved in crafting deliverables such as needs assessments and other portions of grant proposals as well as various types of deliverables for educational content. despite the trust that should be inherent in receiving health care, how do we know those providing it are competent? we hope that the system in place helps these clinicians establish a standard of excellence based on licensing requirements. however, measures of clinician competence in clinical, cognitive, and communication skills were historically measured only at initial licensure.1 in an effort to keep clinicians competent and updated on advancements in their field, licensing requirements for many health professions mandate continuing education (ce) to maintain knowledge of ongoing changes. from a logical and practical perspective, requiring ce—and in some cases recurring certification exams—is a necessary measure because of the rapid rate of ongoing change in medicine. this article reviews key considerations and practical tips for how medical writers can better understand our clinician audience and develop more targeted materials. ce for health care professionals is sometimes (and often interchangeably) referred to as cme (continuing medical education). cme, however, refers specifically to ce for physicians. according to the accreditation council for continuing medical education (accme), which sets the standards for accredited cme, “continuing medical education consists of educational activities which serve to maintain, develop, or increase the knowledge, skills, and professional performance and relationships that a physician uses to provide services for patients, the public, or the profession.”2 this definition can be adapted and applied to other health care professions. for the purposes of this article, we will use ce to refer to the educational activities of all health care professions, inclusive of cme and physician education. in addition to the accme, ce accreditation bodies exist for other professions, aside from physicians: • the american association of nurse practitioners (aanp) • the american academy of physician associates (aapa) • the accreditation council for pharmacy education (acpe) • the american nurses credentialing center (ancc) • the national board for certified counselors (nbcc) • the accreditation council for education in nutrition and dietetics (acend) • the joint accreditation for interprofessional continuing education many medical writers and editors belong to certain groups of health care professionals. however, many medical writers also have nonclinical backgrounds such as basic science, communication, and journalism. regardless of clinical background, medical writers may be asked to write educational content. this article is intended to give clinicians and nonclinicians alike an overview of how to tailor content to different clinical audiences. with multiple health care professions requiring ce, medical writers often have opportunities to craft educational content for accredited activities. some educational content that medical writers are asked to work on may also be nonaccredited. whether accredited or not, we need to know how to adapt the content to address the needs of the target clinician audience. the market for ce writing starting in 2006 and throughout subsequent years, the ce industry went through significant changes, including adjustaustin ulrich, pharmd, bcacp / freelance medical writer, ulrich medical writing, llc, greensboro, nc continuing education writing: know your clinician audience ce craft corner http://www.amwajournal.org amwajournal.org 44ce writing: know your clinician audience ments to methods, funding, and objectives.3 some professionals thought that ce would no longer exist. however, by 2012, the industry had settled into a sustainable trajectory. the industry continues to grow, with an increasing trend for income reported by ce providers from commercial support in the united states each year, apart from a setback in 2020 likely caused by the covid-19 pandemic (figure). this means continued opportunities for medical writers to capture a share of that funding because content creation is at the core of educational programs. additionally, medical writers may compose needs assessments and other portions of grant proposals. notably, commercial support of ce activities in 2021 accounted for 32% of reported yearly income by accredited us educational providers. in 2021, there were an estimated 28 million learner interactions, about 75% of which were physician interactions.4 because many health care professions are required to maintain a set number of educational hours each year (table 1), ce is not going away in the foreseeable future. despite a large share of the market dedicated to physician education, medical writers will still be asked to create content for other clinicians. given differences in their scope of practice, writing content for other health care professionals (eg, pharmacists, nurses) is not always the same as writing content for physicians. additionally, physician audiences may have different specialties. for example, writing content for primary care practitioners about dementia would need a different approach than writing content for neurologists about dementia. interprofessional education writing often needs a unique approach as well. interprofessional education initiatives may be focused more on concepts like communication and collaboration among team members rather than detailed medical or scientific content. how to write educational content for different health professions the foundation for understanding your clinician audience is knowing their scope of practice and role in the health care team (table 2). for example, a nurse practitioner (np) has a very different role than a registered nurse (rn). an educational program for rns should not include a learning objective for prescribing treatments or making a diagnosis. however, topics covering monitoring vital signs and symptoms or medication administration would be reasonable for learning objectives for this audience. the company you are working with to develop ce content will likely determine the target audience based on educational needs and supporter interest. the audience determines how you approach all deliverables you might be working on. this includes needs assessments for grant proposals and the educational content. as an example, if the education company or institution provides education exclusively to pharmacists, you should not identify educational gaps for physicians for the needs assessment. if you are unsure about the specific role of the target audience within the health care system, always ask. sometimes, your client or employer may be relying on you to determine this. in many cases, you can consult with a key opinion leader in the profession if you need more information. the american medical writers association (amwa) community is also a great resource with many clinician writers, so feel free to phone a friend! medical writers and editors who are familiar with creating ce content should only need to implement small tweaks in the approach to content creation. much of the material figure. total yearly income from commercial support reported by accredited us educational providers, years 2015-2021.4 table 1. number of education hours required by select health care professions5-11 profession average minimum required education hours per year physician (md, do, mbbs)a 12-50 nurse practitioner (np)b 20 physician assistant (pa) 50 pharmacist (rph, pharmd)a 12-20 nurse (lpn, rn)a,b,c 0-15 clinical psychologista 6-20 registered dietitian (rd)a 10-15 do, doctor of osteopathic medicine; lpn, licensed practical nurse; mbbs, bachelor of medicine, bachelor of surgery; md, doctor of medicine; pharmd, doctor of pharmacy; rn, registered nurse; rph, registered pharmacist. aexact number of education hours is determined by state of licensure bsome designations may recertify by examination, which may not require ce credits cmany states have practice hours as an additional or alternative requirement to ce credits http://www.amwajournal.org amwajournal.org 45ce writing: know your clinician audience will be similar, but your target audience will dictate where you dive deep into the details for a given ce program. case study – multidisciplinary oncology program for this case study, assume that you are working with a medical education company to develop content for a multidisciplinary oncology program on non-small cell lung cancer (nsclc). within an oncology practice, health care professionals likely include physicians, nps and pas, pharmacists, nurses, and other support staff. imagine that the education company would like you to create several powerpoint slides to educate each group— physicians, midlevel practitioners (nps, pas), pharmacists, nurses, and other support staff. the program has 4 learning objectives: 1. describe the role of molecular testing in diagnosis and disease classification for nsclc. 2. apply best practices for selecting targeted therapies for nsclc based on genetic alterations and immune checkpoint targets. 3. manage adverse events from nsclc treatments. 4. employ a multidisciplinary approach to providing education on the disease state and treatment plan for patients, their families, and caregivers. as a first step to determining the content to create, you might consider which learning objectives are relevant to each group. for oncology physicians, all 4 learning objectives apply. they are involved in testing, diagnosis, and treatment of nsclc as well as overseeing patient education and the entire patient experience. for nps and pas, all 4 learning objectives also apply. nps and pas can diagnose and treat disease under a physician’s supervision (except for nps in certain states, who do not need a supervising physician). for pharmacists, learning objectives 2, 3, and 4 would be relevant. pharmacists help with treatment selection, monitoring, and patient education in many settings. they table 2. general responsibilities of select health care professionals12-19 profession responsibilities physician (md, do, mbbs) • screen for, diagnose, and treat injury or illness • perform physical examinations; take medical histories; order, conduct, and interpret medical tests • counsel patients on preventative health care and healthy lifestyle practices • conduct surgeries and procedure nurse practitioner (np) • similar responsibilities as physicians • in many states, nps can practice independently • in some states, nps must practice under a physician’s supervision physician assistant (pa) • similar responsibilities as physicians • must practice under a physician’s supervision pharmacist (rph, pharmd) • offer expertise in the safe and effective use of medications • fill and dispense prescription orders, verifying instructions from prescribers • educate patients about their medications, disease states, and healthy lifestyle practices • administer vaccines • in some states, pharmacists can prescribe medications under a physician’s supervision nurse (lpn, rn) • provide and coordinate patient care, including conducting health assessments, medical histories, and monitoring vital signs and symptoms • administer medications, vaccines, and medical devices and other treatments ordered by a prescriber • operate medical equipment • conduct patient education regarding their disease state, healthy lifestyles, and physician’s instructions medical assistant (ma) • measure and record vital signs and other patient information • assist nurses and medical practitioners with their responsibilities • administer vaccines • schedule patient appointments clinical social worker • assist with diagnosis, treatment, and management of behavioral, mental, and emotional disorders • provide therapy for individuals and groups • help individuals develop and implement strategies to cope with situations or change behavior clinical psychologist • screen for, diagnose, and treat behavioral, mental, and emotional disorders • interview patients, administer diagnostic tests, provide psychotherapy to individuals and groups • can prescribe medications in some states registered dietitian (rd) • provide expertise in the use of food and nutrition to manage disease and promote health • assess patients’ nutrition needs, develop and monitor meal plans, and collaborate with the care team do, doctor of osteopathic medicine; lpn, licensed practical nurse; mbbs, bachelor of medicine, bachelor of surgery; md, doctor of medicine; pharmd, doctor of pharmacy; rn, registered nurse; rph, registered pharmacist. http://www.amwajournal.org amwajournal.org 46ce writing: know your clinician audience are generally less involved with initial testing and diagnosis. for nurses, objectives 3 and 4 would be relevant. nurses might administer medications in the clinic, call patients to assess their response to treatment, handle any questions or concerns, and provide education. for other support staff, objective 4 would be relevant. other employees in the clinic may not be directly involved in disease management, but they are still part of the multidisciplinary team. they help educate and support patients, their families, and caregivers throughout the treatment experience. conclusion ce writing (or cme writing) consists of conceptualizing, designing, and writing educational content for practicing health care professionals. this includes physicians, nps, pas, pharmacists, and nurses as well as others. medical writers are often needed to draft needs assessments and other portions of grant proposals as well as various types of deliverables for educational content. when writing content, medical writers need to tailor the education to the target clinician audience. it is important to consider whether the program will be multidisciplinary or only focused on a specific profession. a working knowledge of the roles of clinicians on the health care team will help you create the right content for the target audience. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: austin@ulrichmedicalwriting.com references 1. thompson jn. the future of medical licensure in the united states. acad med. 2006;81(12):s36-s39. doi:10.1097/01. acm.0000243351.57047.2e 2. cme content: definition and examples. accreditation council for continuing medical education. accessed november 28, 2022. https://www.accme.org/accreditation-rules/policies/cmecontent-definition-and-examples 3. marx j. cme: dead or alive? a decade’s perspective. amwa j. 2012;27(4):167-168. 4. accme data report: onward and upward: thriving together in accredited continuing education – 2021. accreditation council for continuing medical education; 2022. accessed march 14, 2023. www.accme.org/2021-data-report 5. state cme licensure requirements. cecentral. accessed november 28, 2022. https://www.cecentral.com/licensure/cme/ 6. continuing education aanpcb. american academy of nurse practitioners certification board. accessed november 28, 2022. https://www.aanpcert.org/recert/ce 7. cme faqs aapa. aapa. accessed november 28, 2022. https:// www.aapa.org/cme-central/cme-faqs/ 8. state cpe licensure requirements. cecentral. accessed november 28, 2022. https://www.cecentral.com/licensure/cpe/ 9. ce requirements by state an overview for rns and lpns. rn.com. accessed november 28, 2022. https://www.rn.com/ ce-state-requirements/ 10. psychology continuing education guide (+ ce requirements by state). psychology jobs. accessed november 28, 2022. https:// psychologyjobs.com/psychology-continuing-education/ 11. maintaining your credential at a glance. commission on dietetic registration. published 2022. accessed march 14, 2023. http:// web.archive.org/web/20221004090926/https://www.cdrnet.org/ maintain 12. occupational outlook handbook: physicians and surgeons. us bureau of labor statistics. modified september 8, 2022. accessed november 28, 2022. https://www.bls.gov/ooh/healthcare/ physicians-and-surgeons.htm#tab-2 13. where can nurse practitioners work without physician supervision? simmons university. published october 25, 2016. accessed november 28, 2022. https://online.simmons.edu/blog/ nurse-practitioners-scope-of-practice-map/ 14. occupational outlook handbook: physician assistants. us bureau of labor statistics. modified september 15, 2022. accessed november 28, 2022. https://www.bls.gov/ooh/healthcare/ physician-assistants.htm#tab-2 15. occupational outlook handbook: pharmacists. us bureau of labor statistics. modified september 8, 2022. accessed november 28, 2022. https://www.bls.gov/ooh/healthcare/pharmacists. htm#tab-2 16. occupational outlook handbook: registered nurses. us bureau of labor statistics. modified september 8, 2022. accessed november 28, 2022. https://www.bls.gov/ooh/healthcare/registered-nurses. htm#tab-2 17. occupational outlook handbook: medical assistants. us bureau of labor statistics. modified october 25, 2022. accessed november 28, 2022. https://www.bls.gov/ooh/healthcare/ medical-assistants.htm#tab-2 18. occupational outlook handbook: social workers. us bureau of labor statistics. modified september 8, 2022. accessed november 28, 2022. https://www.bls.gov/ooh/community-and-socialservice/social-workers.htm#tab-2 19. occupational outlook handbook: dietitians and nutritionists. us bureau of labor statistics. modified september 30, 2022. accessed november 28, 2022. https://www.bls.gov/ooh/healthcare/ dietitians-and-nutritionists.htm#tab-2 http://www.amwajournal.org https://www.accme.org/accreditation-rules/policies/cme-content-definition-and-examples https://www.accme.org/accreditation-rules/policies/cme-content-definition-and-examples http://www.accme.org/2021-data-report https://www.cecentral.com/licensure/cme/ https://www.aanpcert.org/recert/ce https://www.aapa.org/cme-central/cme-faqs/ https://www.aapa.org/cme-central/cme-faqs/ https://www.cecentral.com/licensure/cpe/ https://www.rn.com/ce-state-requirements/ https://www.rn.com/ce-state-requirements/ https://psychologyjobs.com/psychology-continuing-education/ https://psychologyjobs.com/psychology-continuing-education/ http://web.archive.org/web/20221004090926/https://www.cdrnet.org/maintain http://web.archive.org/web/20221004090926/https://www.cdrnet.org/maintain http://web.archive.org/web/20221004090926/https://www.cdrnet.org/maintain https://www.bls.gov/ooh/healthcare/physicians-and-surgeons.htm#tab-2 https://www.bls.gov/ooh/healthcare/physicians-and-surgeons.htm#tab-2 https://online.simmons.edu/blog/nurse-practitioners-scope-of-practice-map/ https://online.simmons.edu/blog/nurse-practitioners-scope-of-practice-map/ https://www.bls.gov/ooh/healthcare/physician-assistants.htm#tab-2 https://www.bls.gov/ooh/healthcare/physician-assistants.htm#tab-2 https://www.bls.gov/ooh/healthcare/pharmacists.htm#tab-2 https://www.bls.gov/ooh/healthcare/pharmacists.htm#tab-2 https://www.bls.gov/ooh/healthcare/registered-nurses.htm#tab-2 https://www.bls.gov/ooh/healthcare/registered-nurses.htm#tab-2 https://www.bls.gov/ooh/healthcare/medical-assistants.htm#tab-2 https://www.bls.gov/ooh/healthcare/medical-assistants.htm#tab-2 https://www.bls.gov/ooh/community-and-social-service/social-workers.htm#tab-2 https://www.bls.gov/ooh/community-and-social-service/social-workers.htm#tab-2 https://www.bls.gov/ooh/healthcare/dietitians-and-nutritionists.htm#tab-2 https://www.bls.gov/ooh/healthcare/dietitians-and-nutritionists.htm#tab-2 v37 n4 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 11 abstract medical writers play a key role in global regulatory submissions across the pharmaceutical industry. before the covid pandemic, many companies were working toward development of global regulatory submissions, with their medical writers playing a key role in this process. during the pandemic, the need for greater collaboration in fully remote working conditions, inclusion and transparency, and the unprecedented demand for speed and quality of clinical development has brought global ways of working into even greater focus. a panel of medical writers, including department and regional heads and subject matter experts, were invited to consider how other influences on our industry may drive the evolution of medical writing yet further as a global profession in the coming years. this article summarizes the panel’s responses to 5 questions on the future direction of the profession. medical writing is an increasingly global profession. during the past few years, the effects of the covid pandemic have only served to increase the ways in which it is possible to be a medical writer on global teams regardless of one’s own location. we invited a panel of medical writers to gaze into their crystal balls and consider how medical writing may yet further evolve as a global profession over the next 10, 20, or more years. participants were invited to consider 5 questions on the future direction of the profession and to provide short responses to as many of the questions as they felt able. our panel included department and regional heads and subject matter experts (smes); their biosummaries can be found at the end of this article. how has the impact of the pandemic and increasing demands on the speed, quality, and complexity of clinical development driven globalization? what solutions initiated from medical writing have been successful to accommodate this change? where might this lead us next? jonathan mackinnon: the pandemic and increasing complexity of clinical development is driving a need for more expansive multinational or multiregional clinical trials that cover a greater geography in order to access increasingly specific participant populations. in response, medical writing associations are increasing education/training efforts in how to manage these changes as part of regulatory document preparation. over time, this might lead us to increased specialization within the medical writer community where—once a writer has an established a base skill set via experience across regulatory documents—they start to specialize in certain areas so that they can stay up to date with the current challenges, eg, data analysis and reporting versus study design and setup. linda yih: in terms of impact, more compounds seem to be moving ahead “at risk,” so teams need to take this into account when it comes to planning and contingencies. successful writers have been able to drive effective julia cooper,1 jeannene butler,2 kelley hill,3 garima pallavi,4 grishma kanchan,4 jonathan mackinnon,5 renee primus,6 matthew renda,3 linda yih,7 and nan wang8 / 1parexel international (irl) limited, dublin, ireland; 2otsuka pharmaceutical development & commercialization, princeton, nj; 3alexion, astrazeneca rare disease, boston, ma; 4parexel international india development & commercialization safety services private limited, bangalore, india; 5parexel international s.l., madrid, spain; 6bristol myers squibb, princeton, nj; 7parexel international llc; 8bayer healthcare co. ltd., beijing, china globalization and the future of medical writing theme article http://www.amwajournal.org amwajournal.org 12globalization and the future of medical writing collaboration and communications, mediate differences, and validate actions to meet overall goals. cultural awareness (whether country, company, or team-specific) has become key to encourage open discussion and ensure all parties are heard and understood. future collaborations may require refined skills in managing conflict, negotiation, influence, and persuasion. renee primus: during and postpandemic, we have witnessed the importance of rapid mobilization to meet new and unexpected global requirements ensuring patient safety and access to treatments. the consequences of global disruption have pointed to the need for greater collaboration, inclusion, and transparency and a call to action for a shared objective among all members of the health care system. members of the medical writing profession have been and continue to be well-positioned as problem solvers during disruption by bringing innovative solutions and leading complex deliverables. for example, covidrelated country-level commitments and the development of processes, tracking, reporting templates, and oversight to meet compliance and quality were key leadership contributions from medical writers—and during a time of urgency and under some extreme conditions. in addition, structural, content, and harmonized updates to existing regulatory documentation (eg, periodic aggregate safety report and the clinical study report) provide another example of leadership from medical writing to drive well-communicated, transparent, and consistent reporting for global digestion. the call to action includes greater data-sharing using secured technologies and harmonized ways of working including more integrated and collaborative health authority (ha) shared accountabilities. nan wang: covid has had a negative impact on a global basis in certain industries, but other professions that can be relatively easily adapted into remote forms will experience heightened demand, such as medical writing. the unprecedented demand for the speed and quality of clinical development has driven us to pursue even higher levels of globalization. ever-increasing global standardization and automation should be the key drivers for a successful medical writing organization. jeannene butler: one “silver lining” for the pandemic was that it necessitated organizations to think differently about the conduct of their clinical trials, and we saw innovative solutions designed to keep clinical development programs moving forward, despite the limitations to person-to person contact. in medical writing, there was also no pause in our work, and globalization of our regulatory submission documents continued to be a focus for our team. we often preplan for global submissions by starting our documents much earlier, even before the completion of the final clinical trial, with region-specific background text and assumed successful outcomes. adding in more automation and technology to this early-writing process can help to reduce the time and effort for the medical writers and may also reduce the impact for rework by the medical writers in the later stages of document development. kelley hill & matthew renda: medical writers have always been able to work remotely. during the pandemic, they exemplified efficient and effective communication, high productivity, and high quality, helping the world adjust to remote work. increased demands leading to increased collaboration across time zones have necessitated the use of shared document platforms and highlighted the importance of careful document handoffs to “follow the sun.” however, the expectation that one is always available increased propensity for “burnout,” which many experienced as time went on. multitasking was taken to an extreme in some cases, which may have led to a decreased ability to focus and affected critical thinking. it will be increasingly important to leverage technology and prospective planning wherever possible and have priority established by management to keep focus and quality from all contributors at its peak. julia cooper: medical writing lends itself to remote working, and this has been a common model in north america and parts of europe for many years. during the pandemic, virtual teams were a necessity (and still are) but also brought benefits such as being able to hire diverse talent in geographical locations where office-based working was previously the norm. employee satisfaction has increased through flexible working hours, autonomy, and the ability to work from different locations. zoom, microsoft teams, and similar platforms help maintain employee engagement; however, building team cohesion can still be a challenge. in the future, we need the technology to evolve yet further (think star trek holodeck!) to provide an environment as close as possible to a face-to-face meeting when opportunities for in-person meetings are limited or nonexistent. grishma kanchan: with increased demands on the speed, quality, and complexity of clinical development, http://www.amwajournal.org amwajournal.org 13globalization and the future of medical writing globalization via social integration has been one of the biggest outcomes of the pandemic. medical writing has predominantly been a geographically diverse team; however, the pandemic pushed us to focus on sustainable and inclusive growth, which required changing our work culture to maximize contributions of people globally. medical writing was quick to implement platforms for global collaborative work. with technologies continuing to improve, we must be open to new ways of working, such as collaboration in the metaverse. the metaverse could aid meaningful interactions between colleagues by replicating an office environment. communication in the metaverse may also be more authentic and build trust when compared with face-to-face conversations which may, at times, be affected by social anxiety or lack of confidence. coming together in the metaverse can be empowering by creating a space where people at work can feel present, connected, and productive. the metaverse could also give medical writers the chance to observe, learn from, and work alongside the best in the industry, without physical or geographical barriers. in clinical development, medical writers could immerse themselves in real-life scenarios and gain insights into a patient’s or physician’s journey to devise solutions for existing challenges. the metaverse may also allow medical writers to understand the “larger picture” by helping to visualize the clinical development process from drug discovery and development to approval and postmarketing surveillance. this could provide writers with key knowledge to understand the target audience and write better and effective clinical documents. how might the medical writing profession be defined in the future, eg, common certification or development programs, shared job descriptions, intergalactic medical writers association, sharing ideas across companies, different relationships between clinical research organizations (cros)/contractors and sponsors, other? linda yih: we can make great strides together by sharing ideas and solutions to common challenges across companies. amwa is already spearheading this effort with industry leads on several important topics. on a more granular level, this can be achieved by building mutually trusting relationships between cros/contractors and sponsors. all involved need to be transparent with their needs and concerns and open to others’ perspectives. jeannene butler: regulatory medical writing is quite different from other types of medical writing and would benefit from having its own global standards and development programs. a global regulatory medical writing organization would allow for a more focused view of our specific writing profession but expanded to include perspectives and ideas from across the world. an increased focus on education for newer medical writers at the undergraduate level is needed. this could be in the form of 1 or 2 courses for regulatory medical writing to be added to the curricula for related health science degrees or expanded to develop an overall medical writing major program at colleges and universities, where common elements of scientific writing are taught, and the regulatory medical writing courses could be a concentration for that major. renee primus: the regulatory writing profession requires recognition as a defined role in driving speed to patient. a common pain point by writers is that they are not always used for their skills in strategic writing and leadership but instead misunderstood as formatters and scribes. the writer brings value as an expert on regulatory requirements supporting regulatory review and approval and accordingly shapes documents to strategically address these requirements. sponsorship across pharmaceutical companies and cros to form well-defined, harmonized, and consistent position profiles capturing core capabilities and responsibilities would promote the profession and effectively pave the way to a degree-facing curriculum integrated with regulatory affairs. a curriculum design recognizing the multiple and overlapping responsibilities between regulatory writers and regulatory strategists would meet the needs of future changes to the regulatory landscape promoting speed to patient. nan wang: medical writing has a long history in europe and north america and is well defined and recognized in the pharmaceutical industry. • in the future, the medical writer’s role and responsibility will be better recognized and accepted in other developing regions, eg, asia-pacific. the trend has already been observed in china. • an industry community facilitating knowledge and experience sharing across companies and the understanding between cros, sponsors and investigators will play a more important role. kelley hill & matthew renda: assuming that “medical writing” in this instance refers to regulatory writing, building a framework for developing writers within secondary education/universities would provide a pipeline of future http://www.amwajournal.org amwajournal.org 14globalization and the future of medical writing writers. this would include a broad framework that begins with superb writing skills as well as expanded skill sets required for data interpretation and detailed knowledge of regulatory governance. to further career development, management training would include strategic planning, project management, resource planning, technology skills, contract negotiation, and the ability to coach for career development. the business of medical writing also requires the need to assess what skill sets are needed for specific projects. in addition, the expanding requirements for transparency and plain language writing offer separate but related paths for development. core competencies could be identified and job levels that are aligned across companies would also help define specific job titles, making them more uniform across the industry. this would help control “title inflation,” which is often the reason writers will leave one company to move to another, which erodes institutional knowledge and experience, the bedrock that medical writers contribute to drug/device development. garima pallavi: clinical trials are becoming increasingly complex; adoption of advanced technology is slowly becoming the norm. the pharma industry is moving toward personalized medicine/precision medicine. this shifting landscape requires medical writers to be adequately equipped to develop expertise in these areas, understand and expertly design studies, and communicate results to regulators. complex study designs call for medical writers to develop the right amount of subject matter expertise. the rapidly changing regulatory terrain also requires medical writers to continually learn and develop their core competencies. the covid pandemic has underscored that the magnitude of globalization in the health care industry is going to see a steep rise. companies that already had medical writing operations spread out globally experienced minimal disruption in their business. to keep up with the rapidly evolving demand in the industry, companies must focus on building a globally diverse talent pool. global capability centers (gcc) are swiftly becoming the new normal, and companies are giving up their traditional beliefs about having a concentrated talent pool to adapt to a gcc model. the advantages of a global talent pool are multifold: from ensuring round-the-clock business continuity to leveraging on a world-class talent pool and building resilient and agile capabilities. building and nurturing a global talent pool will require using shared job descriptions, employing standard hiring methodologies, a common approach to training, upskilling of staff, and applying uniform performance and conduct standards. professional medical writing associations offering certification programs such as amwa and emwa provide vast opportunities for writers to learn and expand their network; however, these associations have mostly had a strong regional presence. to meet the fast-paced demands of the industry, it will be imperative to shift the mindset to have a global community of medical writers, which allows the whole fellowship to develop common skills. covid has taught us that we can successfully organize virtual conferences and training programs and make smes more accessible to colleagues globally. the future of medical writing will be about breaking down silos and unlocking a diverse talent pool that transcends geographical boundaries. jonathan mackinnon: as complexity increases, it’s likely that certification or training programs will become more commonplace to demonstrate a base skill set. within regulatory medical writing, my view is that study design and transparency will be significant drivers of lasting change. • study design: complexity and simplicity are at opposing ends of the pendulum but are increasingly being woven together as more specific interventions (more targeted action and more complex endpoints) are being included in studies looking to simplify participation and minimize burden. medical writers will need to be able to navigate the increased design and analysis complexity as well as participate in risk assessments, derisking (eg, applying passive data collection from digital health technologies to replace on-site clinical assessments), and subsequently simplification. • transparency: regulatory documents used to be considered highly prized proprietary information with restricted access, whereas now, publicly available redacted regulatory documents substantially increase medical writer access to precedent content. consequently, how medical writers engage with precedent and standardized content and how that content facilitates downstream process will form part of a medical writer’s training. what kind of regulatory changes might impact the way medical writers work in future? do you anticipate recent or future regulations (what kind?), or changes at the regulators themselves, driving change for medical writers? what could that look like? jonathan mackinnon: maturation of the understanding of risk and risk mitigation (international council for harmonisation of technical requirements for http://www.amwajournal.org amwajournal.org 15globalization and the future of medical writing pharmaceuticals for human use (ich) e6[r2]) as well as a fundamental shift toward quality by design (ich e8[r1] and the likely reflection of this in ich e6[r3]) will have a material impact on medical writer work in the future. more sophisticated risk management strategies, targeted enrollment and forecasting, and quality-focused study design will change the way studies are designed and analyzed. designing study protocols will combine a greater understanding of risk management and mitigation verbiage with new methodology for constructing studies that focus on critical to quality factors; for clinical study reports, reporting on these strategies will become more commonplace. kelley hill & matthew renda: increased transparency requirements (ie, european union clinical trials regulation (eu ctr)) are already changing the way writers work, as personal protected data need to be identified early as part of an overall disclosure strategy and company confidential information adapted as more information becomes public during development. specific examples: instead of “47 year old female from france,” data output is changed so the text reads “a 40 to 50 year old person from western europe.” one huge change would be if regulators move from the current document-centric common technical document (ctd) structure to a real-time study data flow. advanced computation in the coming decades might permit regulators to automatically interpret trial data with marketing applications built on a rolling basis. in such a future, medical writers would leverage technical and data science skills because documentation would be reduced to introductory/contextual statements, leaving interpretation up to the agencies. renee primus: the regulatory writer carries both technical and strategic expertise; current and future changes to the regulatory landscape, speeding access of new health care products to patients, will require this expertise more than ever and are already happening. over the past 5 years, food and drug administration (fda) initiatives have been introduced with impact to the regulatory writer. for example, real-time oncology review and the assessment aid aim to increase the speed of information for regulatory review and require both exquisite planning and focused reporting of complex and approval-supporting data—with quality. in addition, parallel review initiatives such as fda project orbis require new approaches to work concurrently with multiple participating countries—with speed. accumulus synergy, creating innovative solutions to reduce regulatory review times and transform global data exchange, is another good indication of reshaping the industry by removing barriers to speed of information. in all these examples, the agile regulatory writer possesses the range of technical and behavior skills to both inform needed changes as well as execute in a changing global regulatory environment. nan wang: harmonization of regulations across the globe can be expected to enhance the global simultaneous development and make drugs available to patients quickly. • medical writers in different countries/regions will work more closely and share knowledge and understanding, which will contribute to the establishment of the “global” document strategy and the process to support global simultaneous submission. • medical writers working in specific countries/regions with unique regulatory requirements should take the initiative to understand a global approach and promote local requirements with solutions. they should take the bridging role to implement global-level standardizations. jeannene butler: based on recent learnings from eu ctr, we may need to consider revising the process and/or structure of how protocols and amendments are developed. protocols require structure to clearly define parameters for the conduct of a clinical trial; however, because many trials are now being conducted globally, we need to consider how best to accommodate region-specific changes and requests from has in an expedited manner. for example, eu ctr requests for information (rfi) can come in from various member states, and these require responses, and often protocol amendments, within a couple of weeks. instead of creating and maintaining country-specific protocol amendments for each change, perhaps the protocol could exist in an electronic format with version control and the ability to tag country-specific elements and switch the view depending on the region where the investigator is conducting the trial. how might the skills profile and daily work for medical writers of the future be shaped by enhanced standardization, harmonization, automation (artificial intelligence [ai]), or other factors? jeannene butler: although no ai would ever be able to completely replicate the skill and art of a human medical writer’s work, technology can, and should, be enhanced and socialized to make our jobs easier. if there was an increase in standardization and enhanced technology to assist with the daily work of medical writers, we would need to adapt http://www.amwajournal.org amwajournal.org 16globalization and the future of medical writing by becoming more tech-savvy ourselves, for example, learning the ai systems and coding to modify those as needed for our specific documents. what would not change would be the ability of medical writers to analyze scientific data and craft language around those results, and the critical soft skills of leadership, communication, and collaboration with our project teams and smes. renee primus: strategy and data design to support critical messages and drive labeling claims are key writer competencies but not leveraged enough due to some siloed ways of working across teams where preplanned data templates and lack of technology restrict manipulations. technologies that allow direct interface and strategic data design for automated data entry while maintaining integrity would enhance more direct review and interpretation by regulators. writers working collaboratively to bring their insights will enhance team effectiveness in the production of fit-forpurpose, message-driven documentation that aids the regulatory reviewer in their decision-making roles. in general, the more we remove the unnecessary and replace with strategic information design, the greater the value that writers bring to documentation will be realized. jonathan mackinnon: it is likely that future medical writers’ skill sets will include elements of data science and content management as clinical research transitions from a documentto content-driven industry. rather than developing a document in isolation, writers will be expected to work with interlinked content that is developed in parallel—as opposed to sequential document preparation. kelley hill & matthew renda: consideration of diversity and inclusion are missing from many types of document templates and should become part of the training for medical writers. in addition, as industry moves to adopt automation and content-reuse to aid in document development, commensurate technical proficiency will be increasingly important for future medical writers. nan wang: medical writers will need to be able to translate the dynamic regulatory environment and diverse regional regulatory requirements into standardized and harmonized document strategy in order to foster communication efficiency. they will be able to work across boundaries and codevelop automation (ai) tools, which will add value to the medical writer’s daily work. with the powerful automation/ ai tools in place, medical writers will concentrate more on the generation of the content flow and process management to ensure adequate communication among cross-functional expert groups. julia cooper: technology applications for medical writing are evolving at a pace that would not have been anticipated a few years ago. it may be many decades before ai can fully replace a human medical writer; however, repetitive tasks may soon be accomplished by automation and/or ai, allowing the writer to focus on the science. for example, patient narratives can already be programmed to a large extent. new ai-based tools may enable writers to generate tables and listings via an interface directly linked to the study or submission database, without requiring involvement of a programming team, or to identify trends and patterns in data for consideration when writing results sections. it will be important that we collaborate globally to understand the benefits and limitations of these new tools and what this means for the medical writer skill set going forward. if budget and/or technology was no limit, how would you see global medical writing teams working/collaborating in the future? jeannene butler: in an amazing future for medical writers, there would be standard document templates and language across companies and regions, endorsed by has worldwide, which would only need minor customization for each organization. with standardized templates, ai would then be developed to electronically create the data-driven sections of the documents once the trial(s) have completed database lock and data cleaning. ai would also create and manage all the technical elements of the documents, including tables of contents, abbreviation lists, reference lists, and all formatting elements. background product/regulatory text would be created once by medical writers, reviewed by teams, and stored in a common “master” location that would then be automatically pulled into appropriate sections of the documents. if that text was changed in the master location, it would be automatically changed in every related document, and there would be regional variations tagged as well. medical writers would continue to work with the project smes to draft and refine summary and conclusion text for each document as their main focus. renee primus: modernization of ich m4 guidance on the ctd – in particular on structure/content and leveraging cloud-based templates and tools—would be one great opportunity for the field of medical writing to work together and drive innovation. http://www.amwajournal.org amwajournal.org 17globalization and the future of medical writing kelley hill & matthew renda: structured content use is already being adopted across the industry. perhaps it would be possible to develop a shared platform of common text across all pharma/science for certain topics; for example, disease descriptions that are automatically updated with info from new publications. nan wang: medical writers will work with automation tools much more often. the human medical writer will focus on message and content, and the tool will focus on repetitive and routine tasks in the background. medical writers from different countries/regions will work on global master documents, with knowledge and technical support, and contribute to the packages submitted in different regions. medical writers will be involved much earlier in the process and will obtain better overview of the data flow in drug development. julia cooper: in the future, medical writers will be able to focus on the science, for example, through intelligent access to content libraries for authoring protocols and semiautomated generation of clinical study reports and submission documents. the writer will truly be recognized as an expert in their own right, responsible for guiding the team through the limitations and advantages of an automated document generation process. jonathan mackinnon: ideally, deeper organizational collaboration on document standards, content standards, and content management processes. linda yih: medical writing teams would have a budget and time to train junior staff on live project work and allow them to shadow senior writers to learn the nuances of managing a team with confidence. collaborative authoring tools would support training as well as urgent projects. as new technologies are introduced, writers will need to be agile in their learning while managers provide a safe environment for learning. the next generation of writers may also have ideas on how to use or create technology to work in more efficient and meaningful ways. knowledge-sharing and lessons learned sessions may be held to encourage transparency and continuous improvement. grishma kanchan: metaverse! the metaverse has the potential to break down physical and geographical barriers between people. medical writing is a global team, and with the majority of writers working remotely and virtually, using the metaverse to explore a collaborative world and to be able to connect and interact with one another is an exciting possibility. looking forward the future of medical writing will bring many opportunities to evolve as a global profession, learning to adopt new content-driven ways of working, expanding our skill set into data science, and capitalizing on new technologies that replace repetitive tasks. with a track record for agility, medical writing is well-placed to adapt to this rapidly changing environment. considering some recent developments that could not have been anticipated a few years ago, we need to remain vigilant to anticipate emerging global industry trends and what these may mean for expansion of our skill set. as a global profession, we also need to take ownership and drive these opportunities in a direction that increases the future value of medical writing yet further. author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. author contact: julia.cooper@parexel.com biosummaries jeannene butler is senior director, global head of medical writing at otsuka pharmaceutical development & commercialization, and she leads a team of over 30 medical writers to develop clinical and regulatory documents for the worldwide otsuka organization. jeannene began her medical writing career in 2006 and has been a member of amwa since 2007. she has contributed as a medical writing leader for several major pharmaceutical, cro, and biotech companies. julia cooper, phd, is corporate vice president, head of global medical writing services at parexel international. she leads a team of around 270 clinical and regulatory writing staff across the americas, asia, europe, and south africa. julia has been a member of amwa and emwa since 1995. from 2013 to 2016, julia was based in parexel’s shanghai office, where she helped set up the china medical writers community. she is an emwa nick thompson fellow and serves as chair of the amwa executives advisory council. kelley hill is executive director, medical writing and clinical trial transparency at alexion, astrazeneca rare disease. she is a scientist and professional communicator, http://www.amwajournal.org amwajournal.org 18globalization and the future of medical writing with experience spanning over 30 years across the pharmaceutical industry and academia. she has extensive clinical regulatory and scientific writing experience in complex therapeutic areas, with a focus on rare diseases. she has served as a contributor to and in a leadership role for global clinical regulatory submissions supporting review and approval of drugs for diseases with unmet medical needs. she is an innovator with expertise in process improvement and operational excellence, and her global teams’ performance has redefined benchmarks within alexion for collaborative achievement and efficiency. grishma kanchan is a senior medical writer at parexel international and has been with the organization for close to 7 years. she has a master’s in biotechnology from the university of salford, united kingdom, and predominantly works in the rare diseases and disorders sector. jonathan mackinnon, phd, is an associate director medical writing services at parexel international and a subject matter expert on clinical study protocols. he also teaches protocol development and trial design at the london school of hygiene and tropical medicine. garima pallavi is a senior director at parexel international. she leads the medical writing department in india and possesses around 18 years of regulatory writing and leadership experience. renee primus, phd, is head of global scientific and regulatory documentation at bristol myers squibb with 25 years of experience in nonclinical research and clinical regulatory sciences. renee and her team drive documentation strategy and authoring of message-driven, fit-for-purpose regulatory documents in support of drug development, submissions, and approvals. matthew renda, phd, is director of medical writing operations at alexion, astrazeneca rare disease. he has 12 years of academic research experience focused on gene therapy and 15 years of pharmaceutical development experience providing regulatory submission management and medical writing leadership to optimize cross-functional processes, implement innovative technologies, and efficiently develop clinical documents. nan wang, phd, is head of medical writing at bayer healthcare. she has more than 12 years’ experience in medical writing from both pharmaceutical companies and a cro. nan is a founding member and chairperson of the china medical writers’ community. linda yih, bsc, is a senior director in medical writing services at parexel international. as the global lead for the people development initiative, she focuses on onboarding, professional development, recruitment, and retention of writers as well as managers. http://www.amwajournal.org v38 n3 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 35 it’s hard to believe that summer is over, and the 2023 medical writing & communication conference is coming soon. i am looking forward to being in baltimore. the conference offers wonderful content, including general session presentations by our mcgovern award and alvarez award recipients. other articles in this issue of the journal have more information on the 2023 award recipients and what the conference has to offer. i am excited for the opportunity to learn and connect with you there, while also recognizing that the annual business meeting at the conference marks the transition of our governance year. with my year as amwa president nearly over, i have been reflecting on how much the organization has accomplished this year. thanks to the amwa board of directors (bod), our volunteers, and amwa staff, we have made great strides with 2 major initiatives that began during the presidency of my predecessor, katrina burton. first, our diversity and inclusion (d&i) initiative continues to move forward. the bod has engaged a diversity, equity, and inclusion consultant to guide the development of a strategy to implement inclusion, equity, and diversity enhancements throughout the organization. this strategy will include a vision and overarching goals and objectives. based on the recommendations of the d&i assessment task force, we will develop plans to operationalize those goals, measure outcomes, and create systems to monitor progress and improve our processes. this is a multiyear effort, and i am grateful that the bod has approved the resources to support this important work. second, the new health communication curriculum development task force has begun its work to develop an amwa health communication curriculum. this initiative will support our efforts to recognize and honor the legacy of lori l. alexander, who did so much for amwa and the medical writing profession at large. lori had a passion for health literacy and clear medical information and believed that clear communication is essential to scientific research, meaningful patient–health care professional interactions, and better health outcomes. amwa’s expanded health content will include topics such as tactics for creating effective communication about health, science, and medicine; strategies for presenting information on health and medicine to a variety of audiences; how to develop inclusive health communication; the use of inclusive language in medical communication; and health equity and health disparities issues. i thank the task force members for their hard work and for sharing their professional expertise. i have never seen amwa do so much at one time. keep in mind that amwa has other priorities as well, including organizing the annual conferences, creating and updating educational content and our online learning platform, and enhancing the member experience. i am confident that these initiatives will strengthen the organization. in addition, the bod already has a list of future initiatives to consider. the continuous work to improve organizational effectiveness, promote excellence in medical communication, and increase member value never ceases… it’s a journey. from the president it’s a journey amwa news elise eller, phd / 2022-2023 amwa president http://www.amwajournal.org https://www.amwajournal.org/index.php/amwa/article/view/111 v38 n4 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 17 q1: how do continuing medical education/continuing education (cme/ce) medical writers balance the need for accurate scientific representation with the pressure to create content that aligns with pharmaceutical industry interests? you’d think there was no need to even ask this question. but you’d be wrong. i once worked on a cme/ce project in which a supporter complained that faculty didn’t give sufficient attention to the supporter’s therapy in a live preconference education session. subsequently, the education provider asked me to include additional material about the supporters’ product in the downloadable slide deck “to keep the supporter happy.” this behavior flouts a fair and balanced approach to content, threatens content integrity, and damages the regulatory firewall. accredited cme/ce content must be independent of any third-party influence or commercial interest. standards and mechanisms have evolved in the united states to regulate the planning and delivery of cme/ce content and establish a firewall between commercial interests and education content. these standards and mechanisms are different in other parts of the world. in the united states, the accreditation council for continuing medical education’s (accme) 2020 standards for integrity and independence in accredited continuing medical education specify the types of organization that can provide education, the types of content that they can create, and the criteria for creation. at a minimum, accredited cme/ce content must be evidence-based and adopt a fair and balanced approach to describing and evaluating relevant therapeutic interventions within a recognized standard of care for a given condition or disease. to this end, accme requires that education sponsors (often, but not exclusively, pharmaceutical manufacturers) have no role in determining content, editing, or providing materials to support the content. medical writers are instrumental in developing content for the purpose of educating health professionals on how to provide care for and treat patients. as such, we are de facto bricks in the regulatory firewall. it’s our job to ensure that content meets the requirements of accreditation, so we need to be meticulous in the sources we review and use to create that content. we also need to be aware of the mechanisms in place to protect content integrity and prevent commercial influence. these mechanisms include financial and conflict of interest disclosures as well as independent and thorough content review processes. for the most part, these mechanisms are sufficient to maintain the firewall. however, writers need to be aware that when pharmaceutical manufacturers issue requests for proposals to design and deliver education programs or activities, they have internal objectives that they expect such education to meet. the business and sales managers within education provider organizations know this. their role in securing funding via the grant development process involves a delicate dance to ensure that content remains firmly within the 2020 accme standards framework, yet also implicitly appeals to supporter interests. at times, they might zealously communicate these interests to writers. this is a form of tacit pressure. similarly, when needs assessments are narrowly focused on a specific therapy compared with objectively identifying clinical and professional practice gaps, content is already skewed toward sponsor interests. writing extensively about clinical trial data for one particular therapy is a common way that content gets skewed. as writers, we are bricks in the firewall between industry and education, charged with maintaining content independence and integrity. we can do this by raising our awareness of areas in which tacit pressure can creep into the content development process and by pushing back on any potential to breach the firewall. —alex howson it is not unusual for a pharma/biotech client to try to “spin the data” in a continuing medical education (cme) or other educational article so that a favorable light shines on their own drugs or therapeutic agents. the accreditation council for continuing medical education (accme) has published guidelines/rules for cme material to qualify for accreditation and, presumably, most cme providers do try to adhere to these guidelines. you can access these guidelines easily freelance focus alex howsonbrian bass cathryn d. evans http://www.amwajournal.org https://accme.org/publications/standards-for-integrity-and-independence-accredited-continuing-education-pdf https://accme.org/publications/standards-for-integrity-and-independence-accredited-continuing-education-pdf amwajournal.org 18freelance focus via google search. nonetheless, some companies and/or their agencies will try to slither in a little bias toward a company product—this is not very difficult if the writer/author is clever. whether you are involved in accredited cme, continuing education (ce) for pharmacists, nurses, or nonaccredited educational material sponsored by a pharma/biotech company, the ethics remain the same, even if specific “rules” have not been published. members of amwa, as professional medical writers, are ethically obligated to pay attention to guidelines about content, sources, references, authorship, contributions, and acknowledgements. how to balance the needs vis à vis pressure from clients? first, we must speak freely and openly with clients to let them know when the ethical lines are starting to be crossed. second, if we are going to be asked to spin toward the positive—or even hide data, perish the thought—it is essential that we address this in fair balance with other similar and likely competitive therapies by including appropriate information about the other products as well. if you do not have the moral integrity, or the professional confidence, to speak openly with your client about such things, probably you should not be a medical writer in pharma/biotech. these messages can be delivered quite diplomatically, no need for friction or hard feelings. we simply explain the rules, regulations, and guidelines around ethics in medical communication. please note: if your client refuses to adhere to ethical standards and insists on the spin, i suggest you tacitly drop that client. (but, just in case of a future lawsuit,always make sure your recommendations are in writing, either in an email or within a manuscript— without in any way accusing the client, of course.) i have had to do this numerous times; it is not easy, but i do it. so should you. —cathryn d. evans * * * q2: when working on manuscripts involving multiple authors, how can medical writers help manage authorship disputes and ensure fair credit allocation following ethical guidelines? it is not within the purview of a freelance medical writer to determine authorship or mediate their disputes—at least it should not be. if clients are passing this responsibility on to you, they are essentially asking you to be more than a medical writer; they want you to be the project manager, a function that pays more than medical writing, so be sure to raise your rate if a client asks this of you. yes, i have had to take this role at different times. generally, i am crystal clear in my communication with coauthors (and clients) about guidelines and regulations; likewise, i am usually well aware of the politics within companies and academia, so i address the issue directly. the politics are out of our hands—this is up to the client and/or the chief author, investigator, or scientist. we cannot take responsibility for the politics. —cathryn d. evans * * * q3: how can medical communicators navigate cultural and linguistic differences in a global health care context, ensuring their work is accurate and culturally sensitive? medical communicators must always consider their audiences when developing content, but there’s more to it than simply writing in one style for regulators, in another style for health care professionals, and in another style for lay audiences. there are differences in the way people learn and in the way people understand that go beyond reading and education levels. for example, although it may have been thought at one time that visuals are the best way to communicate to people with low reading skills, infographics have become a popular way to communicate the results of clinical trials to health care professionals. the ability to access and utilize information is influenced by so many factors: race, ethnicity, age, culture, religion, sex, gender identity, sexual orientation, socioeconomic status, geography, physical ability, and neurobiology among them. with so many possibilities, is it surprising we’re all different? that may be the biggest thing we have in common! although medical communicators should have always thought about at least some of this, diversity, equity, and inclusion (dei) finally being at the forefront makes it a lot easier. now our companies and clients are thinking about it, too. i think they’re also more receptive to our doing something about it. it was wonderful when the american medical association (ama) manual of style, 11th edition, gave us permission to use “they” as a singular pronoun. the circles we used to have to write around a sentence in order to de-gender it! one of the best ways i can think of for medical communicators to navigate cultural and linguistic differences in the global health care universe is to think about dei constantly and allow it to drive questions up front about how a particular communication piece will be delivered, to whom it is intended, and what considerations can and should be made to optimize its value to this audience. this should be an actual topic of conversation at the beginning of any project— an agenda item! establishing these guardrails from the beginning will help us develop content that is best suited to achieve its communication objective. i also think it is important for us http://www.amwajournal.org amwajournal.org 19freelance focus to consider the characteristics we give to patients when writing hypothetical case studies and patient journeys. —brian bass much medical writing already occurs in a global context, requiring cultural awareness to ensure content resonates across different health care settings. writers must consider linguistic, cultural, and identity differences to create inclusive materials that engage diverse audiences. we need to bring this same awareness to cultural and linguistic differences in a us health care context. if you’re a writer in cme/ ce, you are already likely doing so via the concept of cultural competence. almost 20 years ago, the commonwealth fund defined cultural competence as “the ability of providers and organizations to effectively deliver health care services that meet the social, cultural, and linguistic needs of patients.” to this end, accreditation bodies such as accme, the american nurses credentialing center, and the accreditation council for pharmacy education expect cme/ce providers to integrate cultural competence into education for the intended learner audience, be they physicians, pharmacists, or nurse practitioners. the california medical association, which accredits cme organizations in california, has also developed standards to ensure the inclusion of cultural and linguistic competency statements in accredited cme, as well as content that addresses, implicitly or explicitly, topics like communication skills, health care disparities, biases/stereotyping, cross-cultural pharmacological issues, and sociocultural factors that affect health beliefs and behaviors. accme is also working to ensure that dei is incorporated into all aspects of accredited education. a primary way to integrate cultural competence standards to cme/ce is by broadening representation within education content, such as in patient cases. we can diversify the social, cultural, and linguistic characteristics of patient cases by using diverse names, describing different marital statuses and relationships, and including images that represent people with disabilities, as well as black, indigenous, and additional people of color, and people in lesbian, gay, bisexual, transgender, queer, intersex, asexual, and many other identities (lgbtqia+) communities. we can also educate ourselves on cultural norms related to communication, decision-making, family dynamics, spirituality, and other factors affecting health and health care. many tools and resources are available to help us navigate cultural and linguistic differences in both the united states and the global health care context, and to integrate cultural competence standards into cme/ce. the association of american medical colleges diversity and inclusion toolkit is a terrific place to start, with resources on how to think about power and privilege, cross-cultural communication, and the diversity of identities in health care contexts. the disabled and here collection, photoability, tonl, the gender spectrum collection, and many other archives provide access to inclusive images. resources such as the inclusive language playbook: writing for lgbtq+ communities,the 11th edition of the ama manual of style, and the council of science editors' perspective on inclusive sex/gender language can help writers avoid discriminatory or stigmatizing language. —alex howson reference 1. detora lm, lane t, sykes a, dibiasi f, toroser d, citrome l. good publication practice (gpp) guidelines for companysponsored biomedical research: 2022 update. ann intern med. 2023;176(3):el220490. doi:10.7326/m22-1460 online resources for freelance writers accme standards for integrity and independence in accredited continuing medical education: https:// accme.org/publications/standards-for-integrity-andindependence-accredited-continuing-education-pdf accme accreditation criteria: https://www.accme.org/ accreditation-rules/accreditation-criteria international committee of medical journal editors: defining the roles of authors and contributors: https:// www.icmje.org/recommendations/browse/roles-andresponsibilities/defining-the-role-of-authors-andcontributors.html association of american medical colleges: diversity and inclusion toolkit: https://www.aamc.org/professionaldevelopment/affinity-groups/cfas/diversity-inclusiontoolkit/resources inclusive language playbook: writing for lgbtq+ communities: https://communicatehealth.com/ wp-content/uploads/ch-lgbtq-playbook.pdf council of science editors: inclusive language communication: https://www.councilscienceeditors.org/ inclusive-language-communication inclusive imagery: https://www.awesomefoundation.org/en/projects/114332disabled-and-here https://tonl.co/ http://photoability.net/ https://genderspectrum.vice.com/ http://www.amwajournal.org https://www.commonwealthfund.org/sites/default/files/documents/___media_files_publications_fund_report_2002_oct_cultural_competence_in_health_care__emerging_frameworks_and_practical_approaches_betancourt_culturalcompetence_576_pdf.pdf https://www.aamc.org/professional-development/affinity-groups/cfas/diversity-inclusion-toolkit/resources https://www.aamc.org/professional-development/affinity-groups/cfas/diversity-inclusion-toolkit/resources https://www.awesomefoundation.org/en/projects/114332-disabled-and-here http://photoability.net/ https://tonl.co/ https://genderspectrum.vice.com/ https://communicatehealth.com/wp-content/uploads/ch-lgbtq-playbook.pdf https://communicatehealth.com/wp-content/uploads/ch-lgbtq-playbook.pdf file:https://accme.org/publications/standards-for-integrity-and-independence-accredited-continuing-education-pdf file:https://accme.org/publications/standards-for-integrity-and-independence-accredited-continuing-education-pdf file:https://accme.org/publications/standards-for-integrity-and-independence-accredited-continuing-education-pdf https://www.accme.org/accreditation-rules/accreditation-criteria https://www.accme.org/accreditation-rules/accreditation-criteria https://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html https://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html https://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html https://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html https://www.aamc.org/professional-development/affinity-groups/cfas/diversity-inclusion-toolkit/resources https://www.aamc.org/professional-development/affinity-groups/cfas/diversity-inclusion-toolkit/resources https://www.aamc.org/professional-development/affinity-groups/cfas/diversity-inclusion-toolkit/resources https://communicatehealth.com/wp-content/uploads/ch-lgbtq-playbook.pdf https://communicatehealth.com/wp-content/uploads/ch-lgbtq-playbook.pdf https://www.councilscienceeditors.org/inclusive-language-communication https://www.councilscienceeditors.org/inclusive-language-communication https://www.awesomefoundation.org/en/projects/114332-disabled-and-here https://www.awesomefoundation.org/en/projects/114332-disabled-and-here https://tonl.co/ http://photoability.net/ https://genderspectrum.vice.com/ v38 n1 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 54 the first scientific journal, philosophical transactions, was founded in 1665.1 at that time, and for more than 2 centuries thereafter, scientific manuscripts did not have a standardized form or style. however, in the 1940s, a standard structure began to emerge. decades later, in the 1980s, a standard structure was widely adopted for original research manuscripts in the sciences.2,3 most research manuscripts are now written in a standard structure known as imrad (introduction, methods, results, and discussion).2,3 in this structure, the introduction describes the background of the study, the methods describe how the study was carried out, the results report what the study found, and the discussion explains what the study findings mean. this standard imrad structure makes the process of developing and publishing manuscripts more consistent and easier to manage. this structure helps authors organize their ideas and ensure they include all the important elements of the study. the imrad structure also helps editors and reviewers evaluate manuscripts more easily. and the structure helps readers to quickly locate specific information without going through the entire paper.3 the imrad structure has another valuable feature. this structure helps authors to tell a story with the most common story structure: the three-act structure. three-act story structure the three-act structure contains 3 acts separated by 2 plot points (figure 1a). in act 1, the story starts with the setup, or exposition, which is when readers learn about the setting and characters in the story. at the end of act 1 is plot point 1. here, readers encounter the tension, or an inciting incident. this tension engages readers’ curiosity, excitement, or other emotion so that they want to keep reading the story. act 2 is the action in the story. the action builds momentum, further engaging readers as the story approaches act 3. near the peak of the action, the story hits plot point 2. at this point, readers reach a cliffhanger that heightens their emotions to entice them to keep reading the story. in act 3, the story peaks at the climax and then ties everything together in the resolution, or denouement. in this way, act 3 relieves the tension, or the heightened emotions, created at the end of act 1. three-act story structure in manuscripts the imrad structure of manuscripts maps onto the threeact story structure (figure 1b). crystal r. herron, phd, els / managing director, redwood ink, san rafael, ca the intrinsic story structure of original research manuscripts conscious writing figure 1. three-act story structure in original research manuscripts. a) three-act structure commonly found in stories. b) threeact story structure found in original research manuscripts that follow the standard imrad (introduction, methods, results, and discussion) structure. http://www.amwajournal.org amwajournal.org 55the intrinsic story structure of original research manuscripts act 1 setup in a research manuscript, act 1 is the introduction section. this section is the exposition of the story, when readers learn about the characters and setting of the study. for example, the characters in a manuscript might be proteins, drug compounds, diseases, or patients. and the setting might be a particular cell type, organ, hospital, or population. act 1 also includes any other background details that might be important for readers to know to understand the story in the study. for example, readers may need to know statistics about a particular condition, why existing drugs are ineffective, or how the structure of a mutated protein influences a particular disease state. these background details help to frame the purpose of the study—what problem the study aims to address. this purpose helps readers understand the relevance and significance of the study. and it helps to frame the tension. tension the tension in a manuscript is the research question at the end of the introduction. this question describes what the characters need to accomplish in the story. in other words, how can the characters help to solve the problem you framed in the setup? the tension also needs to state what specific question the study proposes to answer and how that question is connected to the problem framed in the setup. for example, does the new drug need to slow disease progression? or does the gene mutation need to improve organ function? this framing sparks curiosity and excitement in readers to entice them to keep reading into act 2. act 2 action in a research manuscript, the action includes the methods and results sections. the methods section starts the action by describing what happens to address the question in the story. in other words, what approach was used, what experiments were carried out, what data were collected, and what analysis was done in the study? the second part of the action is the results section. this section builds on the momentum created in the methods section by reporting the findings in the study. these findings build on each other as the story approaches act 3. at this point, readers learned the study findings, but they may not yet have a clear understanding of whether the findings answered the study question. this moment creates a cliffhanger that propels readers into act 3. act 3 climax the climax is the first paragraph of the discussion section. this paragraph describes whether the characters answered the question raised with the tension. to maximize the impact of the climax, this paragraph needs to remind readers of the study question, summarize the key findings of the study, and state how those findings answered the question in the tension. this structure reinvigorates and then satisfies readers’ curiosity and excitement about the study. resolution act 3 also contains the rest of the discussion section, including the final conclusions paragraph. the discussion section explains how the characters and their setting changed as a result of the action in the study. in other words, how do the findings fit within the existing body of literature? do they support or contradict findings published in other studies? and, importantly, how do the findings advance the field? at the end of act 3 is the conclusions paragraph. this paragraph is the denouement of the manuscript that ties the entire study together by (1) reminding the reader of the problem in the setup, (2) reiterating the question that creates the tension, (3) highlighting the main study findings in the action, (4) stating how the findings answer the question in the climax, and (5) emphasizing how the study advances the field in the resolution. in this way, the conclusions paragraph leaves readers with a clear concept of the overall relevance and significance of the story in the study. building the story the three-act story structure includes 5 stages—setup, tension, action, climax, and resolution—that can be condensed to form the abbreviation stacr. each of the stacr elements has an important function in a story that helps to engage readers and keep them reading. these stacr elements also map onto the imrad structure of original research manuscripts, creating a built-in story structure that engages and informs readers about a research study. author declaration and disclosures: the author notes no commercial association that may pose a conflict of interest in relation to this article. author contact: crystal.herron@redwoodink.com references 1. history of the royal society. the royal society. accessed october 27, 2022. https://royalsociety.org/about-us/history/ 2. sollaci lb, pereira mg. the introduction, methods, results, and discussion (imrad) structure: a fifty-year survey. j med libr assoc. 2004;92(3):364-367. 3. wu, j. improving the writing of research papers: imrad and beyond. landscape ecol. 2011;26,1345-1349. http://www.amwajournal.org https://royalsociety.org/about-us/history/ v38 n2 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 22 abstract a high-performing medical writing team begins and ends with talented writers, editors, and leaders who understand their mission and their business. a panel of writers comprising the authors convened virtually on october 28, 2021, at the american medical writers association national conference to discuss this topic. the topics of value proposition and business models, communication and leadership, and financial acumen and corporate responsibility will be reprised in this 3-part series, along with thoughts from the authors looking to the future of the business of medical writing, including what we can do in the medical writing community to introduce these topics earlier in the medical writing career path. a high-performing medical writing team begins and ends with talented writers, editors, and leaders who understand their mission and their business: the value proposition, the finances that drive strategy and decision-making, the financial goals, and effective communication. to execute the organization’s goals, leaders must orchestrate resources and often have to balance dynamic variables including budgets and governance that provide bidirectional input into the business strategy.1 a panel of writers comprising the authors convened virtually on october 28, 2021, at the american medical writers association (amwa) national conference to discuss this topic.2 the authors felt the topic was apropos given that they themselves have experienced—and often hear from other writers—that business-related topics in medical writing are learned on the job, midto late-career, when writers are expected to be able to analyze and synthesize knowledge across the business portfolio of assets,1 often in high-stress and rushed circumstances without the benefit of prior observation. the panel members shared their own journeys as business leaders and the methods they used to strengthen the business acumen of their teams. discussion topics included identifying and defining a compelling value proposition; models to teach financial understanding and oversight; business leadership skills, anchored by simple, clear communication, to keep teams motivated and engaged with their mission; collecting data to measure the effectiveness of teams and prioritize and allocate resources in support of business goals; and communication styles to support critical business drivers such as team focus and engagement. the topics of value proposition and business models, communication and leadership, and financial acumen and corporate responsibility will be reprised in this 3-part series, along with thoughts from the authors looking to the future of the business of medical writing, including what we can do in the medical writing community to introduce these topics earlier in the medical writing career path. the authors’ collective experience comprises the following medical writing work environments: • freelance business • small business/vendor • department leadership of smallto mid-size biotech company and large-sized pharmaceutical company the moderator’s (joan affleck ja) prompt is provided for each topic, followed by each perspective on the topic. in some cases, text from the session has been paraphrased for optimal clarity in this medium. defining value value proposition ja: let’s start today with a fundamental question for each of us. we often hear the buzz phrase “value proposition.” that’s the idea that there’s a service or product that is attractive and valuable to a customer or end user.1 in my regulatory medical writing department, our value proposition, in brief, is that we develop documentation to support the research and development objectives of a much larger organization. so, what does your value proposition mean in your organizations, and why is your value proposition important in the big picture? topical feature part 1 in a 3-part series the business of medical writing: understanding the value proposition and successful business models joan affleck, mba1; dominic de bellis, phd1; brian bass, mwc2; and jeanette m. towles, ma, rac-drugs3/ 1merck & co, inc, rahway, nj; 2bass global, inc, fort myers, fl; 3synterex, inc, dedham, ma http://www.amwajournal.org amwajournal.org 23understanding the value proposition and successful business models jeanette, could you start? jeanette towles (jt): i’ll start by saying what our value proposition is: “we apply our years of experience and current regulatory and technical knowledge to help deliver important new therapies to patients in an expedient manner. we are a best-in-class firm and take pride in our operational excellence.” for me, a value proposition means: 1) what we bring uniquely to the table if a customer wants to work with our company; 2) what we stand for; 3) what challenges we solve; and 4) what gains we offer (figure 1). hopefully, by convincing the customer [that] we can use our years of experience, we make the sale—and the company not only chooses us but also keeps coming back to us. we strive to leave the impression with our customers that we should really be their go-to to get things done. this proposition also translates well to the in-house setting. ja: dom, is that something that resonates with you, being in big pharma? dominic de bellis (dd): being the go-to to get things done always resonates with me! it’s important to understand that, regardless of whether [you’re] independent or in-house, your goal is really the same: to provide [an] excellent product to the client. for the freelancer, that will be another organization, and for the in-house medical writer, that’s your clinical team or your document development team. you’re a smaller piece of a bigger organization if you are in-house, but the requirements from the writers’ or teams’ perspective are very similar; it is a question of how you manage the team to affect the success of the document as a whole. ja: and brian, in the freelance context, what’s that like? brian bass (bb): in the freelance world, value is paramount. if we are not bringing value to the table, we are not going to be able to make a living wage and ultimately keep our clients. the value proposition from the freelance standpoint is to remember that first and foremost we are problem-solvers. clients come to freelancers when they do not have someone on staff (or another freelancer they have worked with) who can get the job done. especially when clients reach out to you as a new freelancer, they are coming to you with a problem, and our job is to solve that problem. we happen to do it by medical writing, but what we need to understand is what is driving the client’s need to reach out to us. they need us to be confident, and they need to be confident in us. they need to know that we are going to make their job easier. and that’s how freelancers ultimately put forth their value in making their clients’ lives easier. ja: have any of you run into challenges with defining or clarifying that value proposition with your customers? any situations [in which] they didn’t quite understand what it was you were bringing to the table or perhaps misinterpreted it? jt: this comes up fairly often, to be honest—and earlier in my career this was surprising, but it no longer is. i enter each client relationship and document saying i need to prove myself to this client continually for them to keep coming back to me—for example not only that we can execute a clinical study report but also that we can execute a supplemental new drug application in its entirety. needs, requests, and the regulatory environment change over time, so i have personally faced continual challenges. i also worked with an organization that was in such a funding situation that we kept getting questions about every dollar and figure 1. defining a value proposition. http://www.amwajournal.org amwajournal.org 24understanding the value proposition and successful business models cent. so, i said to myself that i need to have a conversation with this customer to walk them through what goes into this work. that exercise ended up building trust; they came to understand how many hours went toward producing a particular type of document and all the steps that went into it. in the long run, we received fewer questions, and the tone shifted to a more trusting partnership. if you are having challenges, it is worth having a conversation about them. ja: interesting that trust is something we don’t usually think of as being part of a business plan—but you and brian have both pointed out it most definitely is: trust and confidence. bb: i find that clients often don’t realize what i strive to deliver to them makes their job easier because i anticipate where other freelancers go wrong: not staying in touch and on top of projects, calling at the last minute to say they are behind schedule, things like that. all of those mistakes really are so easy to avoid if you focus on them. but many clients don’t expect that, and they are naturally very pleased. as a matter of fact, i just received an email this morning from a client who said, “you are everything that so-and-so said you were.” and to me, that is the proof of why i work hard to deliver that value proposition. ja: dom, when you are embedded in a company, do you still have the same challenge—do you have to keep proving yourself to customers? dd: it’s very much the same, you are only as good as your last document. that maxim holds true in-house in the same way. the problems we solve may differ: we may be more focused on navigating complex internal processes on behalf of the team, we may be more aware of certain regulations that may be more relevant, and we have to keep our finger on the pulse of those changes. but from a document development and writing standpoint, it’s the same thing: quality is expected, and we need to provide that level of service. i think of our teams as our clients, so there’s “client education” to get the team to understand what’s involved in the work you are doing. everyone learns to write, which is wonderful, but not everyone writes the way we need them to write for a particular document or in a way that’s applicable to the audience you’re writing for. there are many nuances to the craft, and it’s necessary for us to explain that to the client or team as we build trust and get them to see the value proposition. business models ja: ok, so you’ve got your value proposition—this is the value we bring. but then you have to have a way to operationalize that—you’ve got to have a business model that hooks up with your value proposition. let’s talk a little bit about the kind of business model you have today. is it a group, one person, [a] freelancer, in-house employees? what are some factors you consider as a business leader when you’re building a business model? brian? bb: i was an independent freelancer for the first 15 years or so of my business. since the early 2000s, i have been bringing in other freelancers who subcontract with me, including both medical writers and medical editors. my business model had to evolve because i was no longer just responsible for paying attention to how i delivered for my clients in terms of the value i bring to the table. i had to make sure that the other people on my team understand that as well and take that to heart as much as i do. therein lies the challenge for any manager; even though i’m not operating a big department within a large corporation, i am still operating my own department. i am ultimately responsible for any project and any person on my team who is working on it. so, i had to adapt my model to consider the amount of time it takes me to manage the projects, to work behind the scenes with the writers and editors to make sure they are delivering the way i need them to deliver. one way that i am perhaps a little unique compared with other freelancers who bring in subcontractors is that the people on my team are as qualified if not even more qualified than i am, so they are all at the top of their craft. i find that by starting with the very best people, it takes away some of the challenges you might run into with people who have less experience and are still learning their way through the processes. that is what has been working for me. ja: i like how you talked about thinking of your group as your own department because i do just the opposite. i say, okay, i have a department within a large corporation, but i think of it as my own business. so, i like that cross-pollination. bb: clearly it must work if we are both approaching it that way; we are doing the same thing, just from a different direction! trust is something we don’t usually think of as being part of a business plan, but it most definitely is: trust and confidence. http://www.amwajournal.org amwajournal.org 25understanding the value proposition and successful business models ja: exactly, and we are borrowing across each other’s worlds! jeanette, i bet that with your value proposition and that quality element, you, too, must spend a fair amount of time in your business model making sure that other people who are delivering on behalf of your company’s name are doing it at the very highest level and in the way you want them to deliver. is that true? jt: that is absolutely right. “operational excellence” is part of our pitch, and we make sure we deliver on it. similar to what brian was saying, if you are going to pitch yourself as a best-in-class firm, you really need people who have the experience behind that. and not just on paper—we administer a test to make sure, pragmatically speaking, that they live up to the basic standards, that they are focusing on the right things if they have a short period of time to do something. something we introduced recently was a pathway for people who don’t have as much experience in industry; and the reason we did that is two-fold: 1) our resource pool is finite by nature, which covid emphasized because there was a lot of competition for really great talent; and 2) a sense of corporate responsibility to help people coming in at a lower level to work up to where they could eventually do tasks on their own. so, we created a medical writing operations group, and we have folks come in through that pathway, learn what it’s like to be in this function, learn what it’s like to manage a project day-to-day, and approach it that way. by learning the basics in a lower-pressure environment, they have the opportunity to really learn and get exposure to items so they could eventually live up to those same standards that we have to offer on the medical writing side. ja: it's really interesting that brian and jeanette both touched on resourcing; the care, feeding, and development of medical writers and medical communicators; and the search for top talent all as part of the business model. dom, is it the same in your space? dd: i may be repeating myself, but yes, it is in the sense that we also need top people here on our team to do the same kind of work. the finite resource pool is a known challenge for all of us; however, we have to provide the right environment—whether it be training, resources, infrastructure, or established process: these are the things we offer as an in-house environment versus someone who may start out freelancing independently or work with someone more established. it’s the same need for personnel, and the one difference we have in-house is we have the resources available to us to develop and put plans in place or put opportunities in front of people for them to have a broad experience and to become marketable across the industry in medical writing, rather than to become pigeonholed in one particular skill set or document type. we need the same high-quality people. we may have an advantage in what we can offer in terms of training people and developing them, but again, we cannot do that at the expense of quality or the work that has to be done, so it’s a delicate balance. looking toward the future as the moderator of this amwa business of medical writing discussion noted, this panel was an initial dialogue meant to “kick off a broader discussion of the many aspects of business leadership as it applies to our work as medical communicators.”2 learning about business is part of regular training in adjacent fields in industry, for example, for regulatory affairs professionals (figure 2).1,3 the business acumen domain of the regulatory affairs professionals society (raps) competency framework, for example, as a cross-functional domain, is characterized as representing “knowledge content that is broadly relevant to those employed as regulatory affairs professionals.”3 the domain descriptor is the “ability to leverage systems and processes to successfully operate a regulatory function to manage product and organizational risk,” and the topics covered include industry-specific, operational, project management, quality management, and continuous improvement knowledge. the similarity of the regulatory framework’s business domain description to what medical writers encounter in their daily job function—for example, leveraging systems and processes to manage risk—is striking. what is figure 2. regulatory professional competency framework, including business acumen domain. source: regulatory affairs professional society (raps). regulatory competency framework model concept. 2021.3 http://www.amwajournal.org amwajournal.org 26understanding the value proposition and successful business models equally remarkable is that the business domain is considered “broadly relevant” to all in the job function—not just for those considering being in a management position. in this framework, leadership and ethics are “the foundational domains, providing the underpinning for professional success” and are considered as additional skills separate from the business acumen domain, whereas the panelists for the business of medical writing discussion considered them within the same overall umbrella of business skills but placed them with the same level of importance in terms of contribution to overall professionalism. although the dia medical writing competency model references the need to deliver to business objectives and interact with business partners to meet customer needs as part of the writer’s regular functions, tasks, and activities,4-6 it is not clear what business literacy skills medical writers should acquire to prepare them for such interactions. in fact, this model not only prescribes key activities like mapping of a “product’s key messages to customer needs, critical success factors, medical/scientific objectives, clinical plans, and data results across phases of development and global regions,” but assumes that the writer is familiar with how to create important business documents like a business continuity plan. so, the question remains—what content from these disparate sources is most relevant in the medical writing context? furthermore, managers of medical writers are expected to understand many tenets of business interconnectivity, management principles, innovative concepts and organizational theories, finance and budget management, resource and performance management, vendor management, strategic planning, change management, metrics, and more.6 the amwa recommended training outline for regulatory writers, although acknowledging that the skills in the outline are but some of the skills and proficiencies needed for professional success and are subject to regular review and update, similarly does not distinguish business knowledge as a separate training topic and broadly covers the topics of analytical skills, self-management, people skills, and personal development across 2 primary categories that make up the competency along with a third category for document-specific training.7 having a comprehensive business curriculum would benefit the writer in these circumstances toward the goal of developing a strategic mindset while learning fundamental business topics. realizing a value proposition that solidly complements the now-accepted medical writing competencies requires a pathway whereby medical writers can readily learn the skills needed to demonstrate leadership while also participating in decision-making activities earlier in their careers. along with such a pathway is the need to develop the infrastructure of their departments that supports the development of business-savvy medical communicators. the panelists of the business of medical writing discussion (the authors) hope to use the momentum of the interest and enthusiasm of the medical writing community on this topic from the national conference to propel our community forward into further discussions about how business literacy can be incorporated into our training curricula and our practices and processes—and ultimately, perhaps our competency frameworks—so that it becomes an intentional element of training for all writers, enabling them to best support the needs of their organizations and businesses. author declaration and disclosures: j. affleck and d. de bellis are employed by merck & co, inc, and are shareholders. b. bass and j. towles note no commercial associations that may pose a conflict of interest in relation to this article. author contact: jtowles@synterex.com references 1. towles j. the business of medical writing: the small business perspective. presented at: american medical writers association indiana chapter conference [virtual]; april 29, 2022. 2. american medical writers association (amwa). national conference brochure. amwa; 2021. accessed july 03, 2022. https://cdn.ymaws.com/www.amwa.org/resource/resmgr/ conference/2021/2021amwa_conf_program_june15.pdf 3. regulatory affairs professional society (raps). regulatory competency framework model concept. raps; 2021. 4. clemow db, the drug information association medical writing special interest area community competency model working group. pharmaceutical medical writing competency model. amwa j. 2011;26(2):71. 5. clemow db, wagner b, marshallsay c, et al. medical writing competency model—section 1: functions, tasks, and activities. ther innov regul sci. 2018;52(1):70-77. doi: 10.1177/2168479017721585 6. clemow db, wagner b, marshallsay c, et al. medical writing competency model—section 2: knowledge, skills, abilities, and behaviors. ther innov regul sci. 2018;52(1):78-88. doi: 10.1177/2168479017723680 7. yih l, alexander ll. recommended training outline for regulatory writers. american medical writers association (amwa); 2020. accessed march 3, 2023. https://info.amwa.org/ hubfs/offers/regulatory-writer-training%20ebook/regulatorywriter-training.pdf http://www.amwajournal.org https://cdn.ymaws.com/www.amwa.org/resource/resmgr/conference/2021/2021amwa_conf_program_june15.pdf https://cdn.ymaws.com/www.amwa.org/resource/resmgr/conference/2021/2021amwa_conf_program_june15.pdf https://www.raps.org/raps/media/careers/raps_regulatory_competency_framework_2021.pdf https://www.raps.org/raps/media/careers/raps_regulatory_competency_framework_2021.pdf https://info.amwa.org/hubfs/offers/regulatory-writer-training%20ebook/regulatory-writer-training.pdf https://info.amwa.org/hubfs/offers/regulatory-writer-training%20ebook/regulatory-writer-training.pdf https://info.amwa.org/hubfs/offers/regulatory-writer-training%20ebook/regulatory-writer-training.pdf v38 n1 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 36 abstract the language used to describe study participants in the medical literature is of paramount importance. the objective is to use the terms that people use to describe themselves while also being sensitive and consistent, supporting diversity, and conveying respect. it is also important to medical editors that a style guide reflects their responsibilities and need for clear guidance. to this end, the ama manual of style committee reassessed our guidance on race and ethnicity soon after its release in february 2020 because we realized that our guidance already needed to be updated. we started with some small steps, like deciding to capitalize all racial and ethnic categories including black and white, and then ended up dismantling the entire section in our quest to develop more robust, comprehensive, and thoughtful guidance. after almost a year of research, updates, external review, and further revision, we published our efforts to garner public feedback, which was successful and led to further revision and review. when we were confident that our guidance met our objectives, we published our revision in august 2021. our updates include definitions of commonly used terms associated with race and ethnicity, concerns and controversies in health care and research, racial and ethnic collective term usage, alphabetization of racial and ethnic categories, and geographic origin and regionalization considerations, and we provide examples to help guide authors and editors. our current guidance is more reflective and complete, and we plan to make further revisions as the language and culture evolve. the 11th edition of the ama manual of style was published in february 2020, but we made a major update to the section on race and ethnicity a year and a half later because we realized that our guidance needed to be updated to reflect ongoing understanding and the need to report sociodemographic information more accurately, sensitively, and consistently. our goal was to provide recommendations and suggestions that encourage fairness, equity, consistency, and clarity in reporting of race and ethnicity in medical and science journals. “terminology, usage, and word choice are critically important, especially when describing people and when discussing race and ethnicity. inclusive language supports diversity and conveys respect. language that imparts bias toward or against persons or groups based on characteristics or demographics must be avoided.”1 process as we have done with all ama manual of style revisions, we looked at the current guidance on reporting race and ethnicity to determine what was missing and what we wanted to add or change. the ama manual of style committee began reassessment in the spring of 2020 and talked about what the plan would be. after an 8-month process of research, updates, external review, and more revision, we published our initial guidance in february 2021 as an editorial in jama1 with an invitation for wider public review and feedback, hoping to capture the expertise of people we did not seek out initially. this was a first for us and successful because we had dozens of individuals in academia, publishing, and government with expertise in reporting race and ethnicity and diversity, equity, and inclusion reach out with suggestions and advice. it was a lot to sift through, and we encountered several topics for which people outright contradicted one another, but the feedback was invaluable and helped us to build a stronger, more comprehensive section. we sought review once more, and then the final version was published in jama on august 17, 2021.2 a week later, the content was live and freely available in the online ama manual of style.3 key principles in the updated guidance our revised guidance followed 5 key principles. first, we acknowledge that race and ethnicity are social constructs. race is a created concept, not a biological category defined by genetic traits or biological differences. racial and ethnic tracy frey / jama network, chicago, il updated guidance on the reporting of race and ethnicity in medical and science journals topical feature http://www.amwajournal.org https://jamanetwork.com/journals/jama/fullarticle/2783090 amwajournal.org 37updated guidance on the reporting of race and ethnicity in medical journals categories are social constructs with limited utility in understanding medical research, practice, and policy. however, the terms may be useful as a lens through which to study and view racism and disparities and inequities in health, health care, and medical practice, education, and research. the indistinct construct of racial and ethnic categories has been increasingly acknowledged, and concerns about use of these terms in medical and health research, education, and practice have been progressively recognized. second, we knew there would be historical sensitivities and controversies related to the language used to describe race and ethnicity and associated nomenclature in medical and health research, education, and practice, including the intersectionality of ancestry and heritage, social determinants of health, and other socioeconomic, structural, institutional, cultural, and demographic factors. third, race and racism do not exist in isolation, and therefore, racial and ethnic descriptors should not be reported alone. other sociodemographic factors and context should be included as much as feasible, if reporting race assists in the study of disparities and inequities in health, health care, and medical practice, education, and research. language and terminology must be accurate, clear, and precise, and must reflect fairness, equity, and consistency in use and reporting of race and ethnicity. fourth, it should be abundantly clear, particularly in research, what the origin of the categories is. who classified individuals, what categories were available, and how these determinations were made should be clearly described (eg, self-report or selection, investigator observed, database, electronic health record, survey instrument). reporting of race and ethnicity should not be considered in isolation and should be accompanied by other sociodemographic factors, social determinants, and the intersectionality of race and ethnicity with these other factors. finally, and most important, the guidance we have put forth in the manual is not final. the dialogue continues, and we will collect feedback and experience with implementing our guidance, which will allow us to make further updates to it. continual review of the terms and language used in the reporting of race and ethnicity is critically important as societal norms continue to evolve. guidance components the revised guidance includes definitions of commonly used terms associated with race and ethnicity and acknowledges that these terms and definitions have changed, that some are out of date or should not be used, and that the nomenclature will continue to evolve. we address concerns, sensitivities, and controversies in health care and research and provide guidance on the reporting of race and ethnicity in research articles, with the understanding that editors are working with the data that researchers collected. we also provide guidance for capitalization; adjectival, punctuation, and abbreviation usage; and what order to present categories, as well as examples of collective or umbrella terms for racial and ethnic groups. examples are included to help guide authors and editors, and we will continue to collect feedback and more examples to help. in addition, a quiz has been developed on race and ethnicity at the ama manual of style website3 to help editors identify potential issues in reporting and explain the rationale for the correct quiz answer, of which in some cases there is more than one. summary of appropriate terms when reporting race and ethnicity the following is a summary of the preferred terms to use when reporting race and ethnicity in medical and science journals. complete guidance is available at the online ama manual of style,3 and a summary table of appropriate terms is available in the instructions for authors for jama and the jama network journals.4 1. all racial and ethnic categories, including black and white, should have initial capitalization, except when capitalization could be perceived as inflammatory or inappropriate (eg, “white supremacy”). race and ethnicity categories should be listed in alphabetical order, not in order of proportion, and “other” and “unknown” should be listed last. the categories included in “other” groups should be defined and reported. authors should be as specific as possible when reporting on racial and ethnic categories (even if these categories contain small numbers). if the numbers in some categories are small enough to potentially identify study participants, the specific numbers and percentages do not need to be reported provided that this is documented. for cases in which the group “other” is used but not defined, the author should be queried for further explanation. 2. race and ethnicity terms should be used as adjectives, not nouns. they can be modifiers (eg, asian patient, black individual, white populations) or predicate adjectives (eg, patients who are asian, black, or white). 3. most combinations of proper adjectives derived from geographic entities are not hyphenated when used as noun or adjective formations, so do not hyphenate these http://www.amwajournal.org amwajournal.org 38updated guidance on the reporting of race and ethnicity in medical journals terms and similar combinations as nouns or compound modifiers (eg, african american patient). 4. generally, abbreviations of categories for race and ethnic-ity should be avoided unless necessary because of space constraints (eg, in tables and figures). if used, any abbre-viations should be clearly explained parenthetically in the text or in the table/figure footnotes or legends. 5. authors use many collective terms when describing racial and ethnic minority groups. many of these terms carry negative connotations, may be inaccurate or stigmatizing, and may be “too inclusive,” to the point that they erase differences among specific groups.5-8 these terms include mixed race; minority and minorities used as nouns; people of color; brown; and black, indigenous, and people of color (bipoc), black, asian, and minority ethnic (bame), and black and minority ethnic (bme). these terms should be avoided unless they were specifically used in data collection, and in those cases, the term should be defined, if possible. a. the terms multiracial and multiethnic are preferred over mixed race in reports of studies if the specific categories these terms comprise are defined or if the terms were predefined in a study or database to which participants self-selected. b. we recommend using the collective terms racial and ethnic minority groups and racial and ethnic minority individuals, in which minority is used as a modifier and not as a stand-alone term. terms such as underserved populations (eg, when referring to health disparities among groups) or underrepresented population (eg, when referring to a disproportionately low number of individuals in a workforce or educational program) may also be used as collective terms provided the categories of individuals included are defined at first mention. the term minoritized may be acceptable as an adjective provided that the noun(s) that it modifies is included (eg, “racial and ethnic minoritized group”). groups that have been historically marginalized may also be suitable at times if the rationale for this description is provided. however, preference is for the specific racial or ethnic categories included or intended to be addressed instead of using a collective term. c. the terms hispanic, latino or latina, latinx, and latine are preferred to the term spanish speaking. avoid reflexively changing latino and latina to latinx or latine or vice versa and follow author preference. authors of research reports, in turn, should use the terms that were prespecified in their study (eg, via participant self-report or selection, investigator observed, database, electronic health record, survey instrument). d. description of people as being of a regional descent (eg, of african, asian, european, or middle eastern or north african descent) is acceptable if those terms were used in data collection. however, it is preferable to identify a specific country or region of origin when known and relevant to the study. it is generally preferable to describe individuals of asian ancestry according to their specific country or regional area of origin (eg, cambodian, chinese, indian, japanese, korean, sri lankan, east asian, southeast asian). similarly, study participants from the middle eastern and north african region should be described using their nation of origin (eg, egyptian, iranian, iraqi, israeli, lebanese) when possible. for individuals of various ancestries living in the united states, do not reflexively add “american.” however, there are times it is appropriate. for example, individuals of middle eastern and north african descent who identify with arab ancestry and reside in the united states may be referred to as arab american. similar construction would be applicable for other groups such as asian american, indian american, etc. e. in reference to persons indigenous to north america, american indian or alaska native is generally preferred over native american. however, the term indigenous is also acceptable. there also are other specific designations for people from other locations, such as native hawaiian and pacific islander, indigenous people, indigenous peoples of canada, and aboriginal people. if appropriate, specify the nation or peoples (eg, inuit, iroquois, mayan, navajo, nez perce, samoan). f. avoid collective reference to racial and ethnic minority groups as “non-white.” if comparing racial and ethnic groups, indicate the specific groups being compared. researchers should avoid study designs and statistical comparisons of white groups with “non-white” groups and should specify racial and ethnic groups included and conduct analyses comparing the specific groups. if such a comparison is http://www.amwajournal.org amwajournal.org 39updated guidance on the reporting of race and ethnicity in medical journals justified, authors should explain the rationale and specify what categories are included in the “nonwhite” group. g. there are similar concerns about dichotomized comparisons of only 2 racial or ethnic groups (eg, black vs white patients). if such a comparison is justified, authors should explain the rationale for this focused comparison limited to only 2 groups. update to jama network journals’ instructions for authors in addition to updating the style manual, we also updated the instructions for authors for jama and the jama network journals4 with regard to the collection and reporting of demographic data on race and ethnicity. we specify that the methods section should include an explanation of who identified participant race and ethnicity, the source of the classifications used, and the reasons why race and ethnicity were collected for a study. we clarify that specific racial and ethnic categories are preferred over collective terms, when possible, and that authors should report the specific categories used in their studies and define categories included in groups labeled as “other.” the results section should report the race and ethnicity categories of the study population and categories should be listed in alphabetical order in the text and tables. future guidance our next step is to update the sections on sex and gender, sexual orientation, age, socioeconomic status, ability, and persons with diseases, disorders, or disabilities. as with race and ethnicity, we recognize that our guidance in these sections may be dated, inadequate, and sometimes confusing, and we are working to change that. our revision for sex and gender and sexual orientation is in process, and we will soon have our draft updated guidance reviewed by internal and external experts on diversity, equity, and inclusion to ensure we recommend using clear, concise, consistent, appropriate, and inclusive language. some of our interim guidance appears in the instructions for authors for jama and the jama network journals4: the term sex should be used when reporting biological factors and gender should be used when reporting gender identity or psychosocial/cultural factors. the methods used to obtain information on sex, gender, or both (eg, self-reported, investigator observed or classified, or laboratory test) should be explained in the methods section. the distribution of study participants or samples should be reported in the results section, including for studies of humans, tissues, cells, or animals. all participants should be represented, not just the category that represents the majority of the sample. studies that address pregnancy should follow these recommendations, and if the gender identity of participants was not assessed, use the terms “pregnant participants,” “pregnant individuals,” “pregnant patients,” etc, as appropriate. conclusions our race and ethnicity guidance is freely available on the jama website,1 at the online ama manual of style,3 and is linked from the jama and jama network journals’ instructions for authors.4 this guidance is not intended to be final but is presented with the understanding that monitoring will continue, and further updates will be provided as needed. continual review of the terms and language used in the reporting of race and ethnicity is critically important as societal norms continue to evolve. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: tracy.frey@jamanetwork.org references 1. flanagin a, frey t, christiansen sl, bauchner h. the reporting of race and ethnicity in medical and science journals: comments invited. jama. 2021;325(11):1049-1052. 2. flanagin a, frey t, christiansen sl; ama manual of style committee. updated guidance on the reporting of race and ethnicity in medical and science journals. jama. 2021;326(7):621-627. 3. ama manual of style. accessed august 26, 2022. https://academic. oup.com/amamanualofstyle 4. jama instructions for authors: reporting demographic information for study participants. jama network. accessed august 26, 2022. https://jamanetwork.com/journals/jama/pages/instructions-forauthors#secreportingrace/ethnicity 5. racial and ethnic identity. apa style. accessed august 26, 2022. https://apastyle.apa.org/style-grammar-guidelines/bias-freelanguage/racial-ethnic-minorities 6. kim te. the perils of “people of color.” the new yorker. published july 29, 2020. accessed august 26, 2022. https://www.newyorker. com/news/annals-of-activism/the-perils-of-people-of-color 7. lamuye a. i am no “person of colour”, i am a black african woman. the independent. published july 31, 2017. accessed august 26, 2022. https://www.independent.co.uk/voices/phrase-peopleperson-colour-bme-black-woman-women-different-experiencesrace-racism-a7868586.html 8. falcon a. latinos and the “of color” problem. al día. published april 3, 2018. accessed august 26, 2022. https://aldianews.com/ articles/opinion/latinos-and-color-problem/52221 http://www.amwajournal.org https://academic.oup.com/amamanualofstyle https://jamanetwork.com/journals/jama/pages/instructions-for-authors#secreportingrace/ethnicity https://jamanetwork.com/journals/jama/pages/instructions-for-authors#secreportingrace/ethnicity https://apastyle.apa.org/style-grammar-guidelines/bias-free-language/racial-ethnic-minorities https://apastyle.apa.org/style-grammar-guidelines/bias-free-language/racial-ethnic-minorities https://www.newyorker.com/news/annals-of-activism/the-perils-of-people-of-color https://www.newyorker.com/news/annals-of-activism/the-perils-of-people-of-color https://www.independent.co.uk/voices/phrase-people-person-colour-bme-black-woman-women-different-experiences-race-racism-a7868586.html https://www.independent.co.uk/voices/phrase-people-person-colour-bme-black-woman-women-different-experiences-race-racism-a7868586.html https://www.independent.co.uk/voices/phrase-people-person-colour-bme-black-woman-women-different-experiences-race-racism-a7868586.html https://aldianews.com/articles/opinion/latinos-and-color-problem/52221 https://aldianews.com/articles/opinion/latinos-and-color-problem/52221 v37 n4 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 40 abstract there is a direct correlation between digital content and greenhouse gas emissions. we have an ethical obligation to mitigate our climate impacts when we can to prevent harm. anthropogenic climate change is expected to have significant impacts on the health and wellbeing of all humans,1 resulting in more intense heatwaves, higher risks of flooding and damaging storms, and a changing pattern of emerging infectious diseases.2 according to the international panel on climate change (ipcc), human-induced warming of the climate system is widespread.3 however, the impacts will be unevenly felt with more dramatic consequences experienced by women, those experiencing poverty, and black, indigenous, and people of color.4-8 although vulnerable or marginalized populations are the first to experience the most severe consequences of climate change, none of us are immune to the long-term impacts. the 2022 ipcc summary for policymakers notes that “near-term actions that limit global warming to close to 1.5°c would substantially reduce projected losses and damages related to climate change in human systems and ecosystems.”9 with that in mind, we all have an ethical obligation to mitigate our climate impacts when we can. what does this have to do with medical writing? there is a direct correlation between the content that we create and the generation of greenhouse gas emissions. “digital is physical,” says gerry mcgovern in his book, world wide waste.10 digital communication—which are the majority of our communication efforts—is/has a huge climate impact. every bit and byte that we create is nothing more than energy. energy is quantifiable. and for the foreseeable future, the use of energy emits greenhouse gases, with direct impacts on the health of vulnerable populations. therefore, we have an ethical responsibility to consider those impacts as we consider our content strategy, content design, and content governance. understanding climate footprint in recent decades, we have been taught to focus on our personal climate footprint; we must make changes to our personal lives to influence the course of climate change. although there are certainly many options for change on a personal level—household solar arrays, electric vehicles, vegan lifestyles, and abandoning air travel, to name a few— no individual lifestyles changes have as much impact as those we make at work. a 2017 report published by cdp, the not-for-profit organization that runs the global disclosure system, states 100 companies are responsible for more than half of all greenhouse gas emissions since the start of the industrial revolution 250 years ago. these organizations are responsible for 71% of all emissions since 1998.11 if most emissions are driven by corporations, then it makes sense that we have the most opportunity for leveraging our impact at work. the carbon cost of data there is a direct correlation between energy and data. according to a report published by the nonprofit research organization the american council for an energy-efficient economy, each gigabyte (gb) of data requires 5.12 kwh of energy.12 this is a very abstract number; plugging this information into the greenhouse gas equivalencies calculator from the us environmental protection agency (epa) shows that every gb of data generates approximately 5 pounds of greenhouse gas emissions.13 note that the epa calculator is regularly updated to reflect the current emissions per kwh in the united states. although the world is moving away from reliance on fossil fuels, progress is slow. according to the latest data from the us energy information administration, in 2021, the united states generated approximately 20% of its energy from renewable sources.14 even if we increase our domestic renewable energy production by 10% annually, we’ll still be relying on fossil fuels for about half of our energy in the united states in 2030. alisa bonsignore / clarifying complex ideas, llc, phoenix, az first, do no harm: ethical considerations surrounding the environmental impact of our digital content everyday ethics http://www.amwajournal.org amwajournal.org 41ethics surrounding the environmental impact of our digital content emissions example 1: websites inbound marketing company hubspot reports that the average home page weight was close to 2 mb in 2020.15 the ninetieth percentile of webpages weigh more than 7 mb per page.16 in the process of research for this paper, i took a random sampling of hospitals, corporations, insurance companies, and health-focused nonprofits—literally the first 8 that came to mind—and ran them through the pingdom calculator that measures page weight, load times, and performance.17 all of the home page weights were significantly greater than the 2.0 mb average reported by hubspot. anyone who uses the internet knows that the standard for modern webpages involves large hero images, videos, or carousels that largely fill the screen. as tom greenwood notes in his book, sustainable web design, roughly half of the weight of a modern webpage is imagery.18 worse, that imagery tends to be stock art that slows download times and adds carbon emissions, without adding value to the user’s experience. this practice goes against the concept of plain language, as advocated by balmford.19,20 he asserts that “plain language” is not wholly accurate. it’s not simply about the choice of words and sentences, but rather the whole document, including language, structure, and design. as communicators, it is our responsibility to consider the best methods for the effective and clear presentation of information. informative images, charts, graphs, and even videos can have a role in effective communication and should be considered on a case-bycase basis. we can achieve our content goals with smaller page weights. at company a, they had an image-intensive home page. at 4.9 mb, it was heavier than the average weight reported by hubspot, within the upper half of the sampled page weights (figure 1). the page was loaded with stock art of health care providers in scrubs and masks; none of these images showed products or services in action, leaving the reader with no visual clues beyond the knowledge that the product was something medically focused. eliminating unnecessary stock images and replacing others with more informative product-oriented photos cut the page weight by half. the result was a page that still met the visual criteria expected from a professional website, but was more informative, downloaded faster, and reduced the carbon emissions by half. the net result was a savings of nearly 17 tons of avoided emissions, or the equivalent of removing more than 3 passenger cars from the road for a year (figure 2). figure 1. sample page weights for health care organizations and health-focused nonprofits. figure 2. reducing page weight also reduces greenhouse gas emissions. http://www.amwajournal.org amwajournal.org 42ethics surrounding the environmental impact of our digital content emissions example 2: comparing the impacts of video and audio just like text, there are times video and audio are indispensable tools for walking customers through setup or use of a product, or for presenting educational information. there are also times in which video is an unnecessary, heavy-weight, flashy video for video’s sake—something that could have been explained just as clearly in text or imagery. the ways in which video can be used are diverse, which makes comparative weighting difficult. instead, let’s compare audio-only podcasting with video podcasting, youtube videos, or recorded presentations. a half-hour video recording, complete with slides and talking head recorded at the youtube quality of 24 frames per second will end up being about 1.73 gb.21 podcast hosting company blubrry estimates that the same information presented as a half-hour long, monochannel, talk-only audio podcast-style recording averages about 23 mb.22 when working with audio and video, it’s important to decide whether a video is worth 75 times the energy and correlated emissions (figure 3). always consider video projects on a case-by-case basis. emissions example 3: our meetings particularly since the start of the pandemic era, we’ve all spent a significant portion of our day on video conferences. but our use of zoom, teams, skype, or related services uses bandwidth and energy, which we now know has a carbon cost. when everyone joins the meeting with video on, the meeting requires roughly 800-900 mb of bandwidth per person.23 for one month, i kept track of all of my daily video meetings. on average, every zoom meeting had 5 participants (some were one-on-one, whereas others were large group calls). when everyone has their video on, that works out to an average of 4 gb of data per call. that same call—the usual screen sharing, the speaker visible in thumbnail, but other participants in video-off mode—works out to be about 190 mb total on a fiveparticipant call. leaving everyone’s video on for the duration is 20 times more energy and emissions intensive as a video-off meeting (figure 4). many employers believe that video-on is crucial for building relationships while working remotely. a good compromise can be to have video on for the 5 minutes of meet-and-greet at the start of the meeting but turning video off during screen sharing. conclusion we all have an ethical responsibility to reduce carbon emissions to mitigate the impacts of climate change, particularly for those who are the most vulnerable. the content that we create generates measurable greenhouse gas emissions. knowing that the majority of emissions come from corporations and not individuals, it makes sense that we leverage our influence on our organizations to have the greatest impact on the health and wellbeing of others. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: hello@clarifyingcomplexideas.com references 1. tennison i, roschnik s, ashby b, et al. health care’s response to climate change: a carbon footprint assessment of the nhs in england. lancet planet health. 2021;5(2):e84-e92. figure 3. the relative data and energy impact of audio versus video. figure 4. video-off meetings use less data, less energy, and generate fewer emissions. 23 mb 1730 mb 0 200 400 600 800 1000 1200 1400 1600 1800 2000 audio video m b of d at a us ed fo r 3 0 m in ut es o f au di o vs . v id eo video is 75x as energy intensive as audio 190 mb 4000 mb 0 500 1,000 1,500 2,000 2,500 3,000 3,500 4,000 4,500 video off video on m b of d at a us ed fo r m ee tin gs w ith a nd w ith ou t v id eo video-on meetings are 21x more data and energy intensive http://www.amwajournal.org amwajournal.org 43ethics surrounding the environmental impact of our digital content 2. watts n, amann m, arnell n, et al. the 2019 report of the lancet countdown on health and climate change: ensuring that the health of a child born today is not defined by a changing climate. lancet. 2019;394(10211):1836-1878. 3. hegerl gc, zwiers fw, braconnot p, et al. understanding and attributing climate change. in: solomon s, qin d, manning m, et al., eds. climate change 2007: the physical science basis. contribution of working group i to the fourth assessment report of the intergovernmental panel on climate change. cambridge university press; 2007:663-745. 4. un womenwatch. women, gender equality and climate change. united nations; 2009. accessed may 27, 2022. https://www. un.org/womenwatch/feature/climate_change/downloads/ women_and_climate_change_factsheet.pdf. 5. van daalen k, jung l, dhatt r, phelan al. climate change and gender-based health disparities. lancet planet health. 2020;4(2):e44-e45. 6. abeygunawardena p, vyas y, knill p, et al. poverty and climate change: reducing the vulnerability of the poor through adaptation. oecd; 2003. accessed may 27, 2022. https://www. oecd.org/env/cc/2502872.pdf 7. yabe t, ukkusuri sv. effects of income inequality on evacuation, reentry and segregation after disasters. transp res part d: transp environ. 2020;82:102260. 8. united states environmental protection agency. epa report shows disproportionate impacts of climate change on socially vulnerable populations in the united states. united states environmental protection agency website. published september 2, 2021. accessed may 27, 2022. https://www.epa. gov/newsreleases/epa-report-shows-disproportionate-impactsclimate-change-socially-vulnerable 9. ipcc. climate change 2022: impacts, adaptation and vulnerability. ipcc website. accessed may 27, 2022. https://www. ipcc.ch/report/ar6/wg2/ 10. mcgovern g. world wide waste: how digital is killing our planet—and what we can do about it. silver beach publishing; 2020. 11. cdp. new report shows just 100 companies are source of over 70% of emissions. cdp website. published 2017. accessed may 27, 2022. https://www.cdp.net/en/articles/media/new-report-showsjust-100-companies-are-source-of-over-70-of-emissions 12. costenaro d, duer a. the megawatts behind your megabytes: going from data-center to desktop. aceee summer study on energy efficiency in buildings; 2012;13:65-76. 13. united states environmental protection agency. greenhouse gas equivalencies calculator. united states environmental protection agency website. accessed may 27, 2022. https://www.epa.gov/ energy/greenhouse-gas-equivalencies-calculator 14. u.s. energy information administration. frequently asked questions (faqs). u.s. energy information administration website. accessed october 17, 2022. https://www.eia.gov/tools/ faqs/faq.php?id=427&t=3 15. stec c. how to reduce page weight on your website [quick guide]. hubspot website. published 2020. accessed june 2, 2022. https:// blog.hubspot.com/marketing/reducing-page-size 16. helvetica h. the 2020 web almanac: page weight. http archive website. published december 9, 2020. accessed june 1, 2022. https://almanac.httparchive.org/en/2020/page-weight 17. pingdom website speed test. pingdom website. accessed june 2, 2022. https://tools.pingdom.com/ 18. greenwood t. sustainable web design. a book apart; 2021. 19. balmford c. getting the structure right: process, paradigm, and persistence (part 1). clarity. 1998;42:42-49. 20. balmford c. getting the structure right: process, paradigm, and persistence (part 2). clarity. 1999;43:14-22. 21. forret p. video filesize calculator. toolstud.io website. published 2022. accessed june 3, 2022. https://toolstud.io/video/filesize.php 22. mp3 (mpeg layer 3) tips for podcasting. blubrry podcasting website. accessed june 3, 2022. https://blubrry.com/manual/ creating-podcast-media/audio/mp3-mpeg-layer-3-tips 23. holslin p. how to reduce zoom data usage. satelliteinternet. com website. published january 11, 2021. accessed june 3, 2022. https://www.satelliteinternet.com/resources/how-to-reducezoom-data-use/ resources pingdom website speed test https://tools.pingdom.com/ video filesize calculator https://toolstud.io/video/filesize.php learn online macroediting microediting save over 15% when purchasing as a package! http://www.amwajournal.org 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american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 42 abstract the legal status of cannabis continues to evolve, raising challenges for medical writers who work in population health and drug safety. to guide messaging, research has investigated how the public perceives cannabis, often relying on surveys or “big data” analyses of social media. however, these methods can be costly. as a supplement, we explored comments posted to a united states food and drug administration docket on cannabis science and risk, which may offer an accessible, purposive, cost-effective source of data. we applied a multipronged methodology that involved content analysis, sentiment analysis, and metadata analysis. the findings suggest that broad messaging on cannabis may have limited effectiveness. instead, medical writers should design messages that emphasize the risks of particular products as well as express empathy for consumers suffering from specific conditions. moreover, among other things, the findings suggest that medical writers should use the terms “cannabis” and “marijuana” intentionally, considering the implications of each. in the future, research should develop methods to further segment drug consumers demographically and psychographically, building on the methodology that we present here. this research may inform not just messaging but regulatory writing practices and state drug policies. the legal status of cannabis has been debated in numerous countries, including the united states (us), where the legal cannabis industry may exceed $43 billion in sales by mid-decade.1 there have also been changes in public attitudes. a recent survey by the pew research center found that over the past decade, the number of us adults who oppose cannabis legalization has fallen 20 percentage points, from 52% to 32%.2 moreover, 9 out of 10 us adults now support the legalization of cannabis for medical or recreational use, raising numerous questions for public health.3 the us food and drug administration (fda) subsequently convened a hearing on may 31, 2019, to “obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.”4 although the in-person proceedings concluded at 6:00 pm that day, the discussion has continued through the comments posted to the hearing’s docket. the docket comments are broadly accessible, excepting proprietary and other sensitive information. comments posted to federal dockets have received little attention from medical writers and researchers in adjacent fields. yet, there are several reasons why these comments are potentially valuable. first, the commenters are invested in the legal status of cannabis, and thus their comments provide a form of purposeful sampling (see palinkas et al.5). in aggregate, their comments, similar to social media posts, may texturize our understanding of how the public perceives cannabis, offering a quick and low-cost alternative to surveys.6 second, regulations.gov, where fda dockets are hosted, informs commenters that what they submit may be displayed there. the site relatedly informs commenters that, in addition to official agency uses, third parties may access or collect comments for their own purposes.7-9 third, the fda has stated that comments “can, and do, influence agency decisions,”10 potentially impacting the work of medical writers in regulatory settings. using a multipronged methodology, this study explored who the commenters are on fda docket 2019-n-1482 and what they are commenting about. our specific research questions were 1. what are common themes and concepts in the comments? 2. what sentiment is expressed in the comments? 3. how did the commenters self-identify, based on the demographic categories that the fda provides? 4. what geolocations are the comments attached to? the answers to these questions provided helpful insights into docket comments, suggesting ways that medical writers can gauge public perceptions of cannabis. michael j. madson, phd1 and andrew madson, ma2 / 1arizona state university, mesa, az; 2western governors university, salt lake city, ut data mining fda docket 2019-n-1482: content, sentiment, and metadata original research http://www.amwajournal.org amwajournal.org 43data mining fda docket 2019-n-1482: content, sentiment, and metadata methods our methods involved 3 general steps: scraping the data, clearing the data, and visualizing the data. we briefly explain each below. scraping the data using a custom script in python, we scraped all of the comments posted to the docket by january 2021 (n = 4,300). we also scraped commenter geolocation and demographic category (eg, individual consumers, industry representatives, health care professionals, members of government, etc.). commenters can choose whether to include these metadata or not. cleaning the data this consisted of several sub-steps that are common in data analytics. we removed leading and trailing whitespace, standardized spellings (drug and chemical names, in particular), and filtered out stopwords. our stopwords were honorifics “thanks,” “thank you,” and “sincerely” because these words convey phatic rather than substantive meaning in the data set. they also included prepositions (eg, “of,” “to,” “at”) and coordinating conjunctions (eg, “so,” “and,” “but”), which tend to carry little semantic meaning. for content analysis, we used the stemming algorithm in leximancer, a data analytics program that is commonly used in health-related research.11-14 for sentiment analysis, we lemmatized the data to optimize output from valence aware dictionary and sentiment reasoner (vader), as symeonidis et al.15 recommend. visualizing the data we visualized the data both demographically and psychographically. to do so, we applied content analysis, sentiment analysis, and what we called “metadata analysis.” for content analysis, we uploaded the data set to leximancer, as mentioned above. leximancer calculates the presence and frequency of key concepts as well as their co-occurrence.16(p8) concepts are clusters of terms that tend to “travel together” in a data set and, when grouped together as themes, maximize the relevancy of all the other words in a data set.16(p11) based on the concepts it detects, leximancer produces a heat map showing the relationships between themes and their underlying concepts as well as frequency. the former is indicated by the location of a theme or concept on the map and the latter by its color: the “hotter” the color (with red being the hottest, purple the coldest), the greater the frequency. for sentiment analysis, we used vader, which takes a “bag of words” approach. that is, it analyzes lexical features that, based on their meanings, are typically perceived as positive, negative, or neutral.17 in our study, we used vader to calculate a compound sentiment score for each docket comment and then average a final score for the whole data set. for both subjectivity and polarity, sentiment scores are normalized between −1.0 (negative sentiment) and 1.0 (positive sentiment).17 for metadata analysis, we focused on how commenters self-identified as well as where the comments were geolocated. specifically, we quantified the frequency of each fda demographic category, each country attached to the comments, and each us state attached to the comments. we charted these findings through microsoft excel and tableau. results what are common themes and concepts in the docket comments? our content analysis with leximancer identified 10 common themes in the data set, which are displayed in figure 1. the most common theme was cbd, referring to cannabidiol (10,954 occurrences). its primary concept, cbd, tended to co-occur with oil (2,093 co-occurrences), use (1,902), take (1,260), helped (1,110), relief (419), milligrams (364), daily (340), doctor (255), and dose (243). the next most common theme was pain (8,138 occurrences). its primary concept, pain, tended to co-occur with chronic (537 co-occurrences), anxiety (519), life (400), sleep (369), work (309), arthritis (280), able (275), tried (251), started (230), better (214), year (182), depression (175), old (121), days (118), down (101), and symptoms (99). the third most common theme was medical (6,883 occurrences). its primary concept, medical, tended to co-occur with effects (305 co-occurrences), prescription (175), need (167), people (154), issues (112), conditions (106), patients (97), cause (74), treatment (73), active (38), and disease (34). the fourth most common theme was products (6,188 occurrences). its primary concept, products, tended to co-occur with hemp (633 co-occurrences), consumer (395), testing (288), benefits (279), supplement (273), extract (266), pharmaceutical (136), food (266), companies (245), potential (190), and form (133). the fifth most common theme was health (5,591 occurrences). its primary concept, health, tended to co-occur with believe (69 co-occurrences), levels (67), access (58), children (57), consider (56), natural (49), available (45), allow (43), provide (42), medicine (42), thc or tetrahydrocannabinol (39), and quality (35). the sixth most common theme was cannabis (5,043 occurrences). its primary concept, cannabis, tended to co-occur with regulations (288 co-occurrences), plant (269), fda (231), support (196), compounds (140), safety (95), http://www.amwajournal.org amwajournal.org 44data mining fda docket 2019-n-1482: content, sentiment, and metadata public (91), industry (85), market (81), cannabinoids (74), information (53), data (51), and based (35). the seventh most common theme was drug (4,197 occurrences). its primary concept, drug, tended to co-occur with legal (97 co-occurrences), control (70), alcohol (49), research (43), studies (40), states (33), and government (33). the eighth most common theme was time (2,824 occurrences). its primary concept, time, tended to co-occur with seizures (53 co-occurrences), family (36), body (29), and cancer (20). the ninth most common theme was marijuana (1,833). its primary concept, marijuana, tended to co-occur with substance (55), law (49), dea or drug enforcement agency (43), respondent (31), and money (20). the tenth most common theme was months (878 occurrences). its primary concept, months, tended to co-occur with night (25). what is the sentiment in the comments? we found that the data set had a mean subjectivity score of 0.418, with a standard deviation of 0.190. the data set had a mean polarity score of 0.121, with a standard deviation of 0.167. how did the commenters self-identify? the fda docket did not require commenters to self-identify by selecting a demographic category. in our sample, only 467 commenters did choose to self-identify: as individual consumers (81 commenters), health professionals (8), international public citizens (1), or representatives of various organizations. most commenters affiliated with an organization chose the most general demographic categories, such as other organizations (157 commenters), association (103), or private industry (32). some were more specific, self-identifying as representatives of the drug industry (23), a consumer group (16), the food industry (8), a health care association (5), or international industry (4). some commenters self-identified as representatives of local (1), state (2), federal (3), or other government (15) as well as academia (5) or the media (2). see figure 2. what geolocations are the comments attached to? the majority of comments were not geolocated, but slightly more than two-fifths (1,821 comments) were. a few comments were reportedly from a geolocation outside of the us: the united kingdom (3), canada (3), australia (2), norway (1), south korea (1), or germany (1). most were from a geolocation in the us, as displayed in figure 3. all 50 states were represented, and so was the district of columbia. the states with the most comments were california (183 comments), texas (152), and florida (128), missouri (82), new york (73), north carolina (66), illinois (62), colorado (57), kansas (57), and wisconsin (54). several other states had at least 50 comments: georgia (52 comments), oklahoma (51), and virginia (50). eight states had fewer than 50 comments but at least 30: washington (46 comments), arizona (43), michigan (41), ohio (40), massachusetts (35), pennsylvania (35), oregon (32), and tennessee (30). nineteen states and the district of columbia had fewer than 30 comments but at least 10: new jersey (29 comments), maryland (27), south carolina (26), indiana (24), figure 1. a heat map generated by leximancer showing the relationships between themes and their underlying concepts as well as frequency. relationships are indicated by the location of a theme or concept, and frequency is indicated by hue. http://www.amwajournal.org amwajournal.org 45data mining fda docket 2019-n-1482: content, sentiment, and metadata kentucky (24), arkansas (23), the district of columbia (23), alabama (22), minnesota (22), nebraska (20), connecticut (19), nevada (19), utah (19), iowa (17), new mexico (15), louisiana (11), montana (11), vermont (11), idaho (10), and new hampshire (10). the states with the fewest comments were mississippi (9 comments), west virginia (9), hawaii (8), rhode island (8), alaska (6), wyoming (6), maine (5), north dakota (3), south dakota (3), and delaware (2). the average number of comments per state was 35.5 with a standard deviation of 36.4. discussion prior “big data” research that explores public perceptions of cannabis has generally focused on social media posts.1828 expanding on this research, our study investigated public comments to fda docket 2019-n-1482, applying content analysis, sentiment analysis, and metadata analysis in ways that may be relevant for medical writers. the content analysis suggests that the commenters were less concerned with cannabis in the abstract and more concerned with specific products and symptoms. of particular concern were cbd and hemp and the treatment of pain, anxiety, and sleep issues. this finding may have relevance for public health messaging: rather than targeting cannabis in general, messages might be more effective if they discuss the risks associated with particular products or if they express empathy for consumers suffering from particular symptoms or conditions. the concepts “use” and “take” appeared frequently in the data. this makes sense, given that a large share of commenters who chose a demographic category self-identified as individual consumers. future messaging should strategically employ different verbs, such as “use” and “take,” so that medical writers can evaluate the effects. on first glance, “take” may have a stronger association with health and medical discourses. “use” may have a stronger association with illicit or recreational activity. such associations may have a significant influence on a message’s overall effectiveness. the content analysis also suggests that cannabis and marijuana have different semantic orientations in the data figure 3. the geolocation of comments in the data set, specific to the us (n = 1,810). darker shades indicate a greater number of comments. figure 2. how the commenters self-identified, based on the demographic categories provided by the fda (n = 467). http://www.amwajournal.org amwajournal.org 46data mining fda docket 2019-n-1482: content, sentiment, and metadata set. “cannabis” was associated with concepts that seem regulatory and scientific, such as safety, public, regulations, compounds, industry, cannabinoids, and data. “marijuana” may have a more legalistic or punitive orientation, considering its co-occurrences with concepts like substance, law, and money. future studies could test how participants respond to messages about “cannabis” compared with messages about “marijuana.” in the meantime, medical writers should use the 2 terms intentionally, considering the possible implications of each. although common in everyday speech, “marijuana” may carry more stigma. the sentiment scores indicated positive polarity and subjectivity. the polarity score suggests that commenters generally had neutral or favorable views of cannabis, which should be confirmed through additional research. the subjectivity score suggests that commenters tended to express personal feelings, opinions, and preferences. it is unknown whether fda officials will consider these subjectivities to be “sound grounds” for decision-making.10 because the number of comments per state was so variable (the average being 35.5 with a standard deviation of 36.4), we did not calculate sentiment scores by state. a richer level of granularity that allows comparisons across states would improve on the methodology that we reported here. that granularity could also support interand intra-state policy evaluations, suggesting how cannabis policies may have “moved the needle.” the metadata analysis was small scale, as only 10.9% of the comments indicated the commenters’ demographic category. more than half of these comments were from other organizations or associations, and slightly less than a fifth were from individual consumers. because these demographic categories are self-reported, they cannot be fully verified. future studies might develop techniques of categorizing demographic information in the comments themselves, beyond the limited categories provided by the fda. it would be interesting, for instance, to examine how sentiment may vary by occupation, education level, income, age, and gender. the findings could support more targeted medical and regulatory communication regarding cannabis as well as policy development. geographically, the metadata analysis indicated that the docket has attracted comments from all 50 us states and the district of columbia as well as 6 countries besides the us. more than half of the comments were not geolocated. of those that were, about a third came from just 5 states: california, texas, florida, missouri, and new york. because most comments were not geolocated, it is not possible to determine the representativeness of the docket comments. indeed, the comments may not be representative of public opinions toward cannabis writ large. yet, the median number of comments per state and standard deviation suggests considerable geographic variation in the docket’s “public participation” and “open exchange of ideas.”29 conclusion at minimum, federal docket comments seem well suited to hypothesis generation based on themes/concepts, sentiment, and metadata. future studies should explore ways to further segment drug consumers demographically and psychographically, building on the multipronged methodology we described here. these studies may inform not just messaging but regulatory communication and state drug policy, 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2019;19(1):1388. doi:10.1186/s12889-019-7494-6 13. singleton ja, lau et, nissen lm. waiter, there is a drug in my soup–using leximancer® to explore antecedents to proenvironmental behaviours in the hospital pharmacy workplace. int j pharma pract. 2018;26(4):341-350. doi:10.1111/ijpp.12395 14. viana jn, edney s, gondalia s, mauch c, sellak h, o’callaghan n, ryan jc. trends and gaps in precision health research: a scoping review. bmj open. 2021;11(10):e056938. doi:10.1136/ bmjopen-2021-056938 15. symeonidis s, effrosynidis d, arampatzis a. a comparative evaluation of pre-processing techniques and their interactions for twitter sentiment analysis. expert syst appl. 2018;110:298-310. doi:10.1016/j.eswa.2018.06.022 16. leximancer user guide: release 4.5. leximancer. published march 10, 2021. accessed october 4, 2022. https://static1.squarespace. com/static/5e26633cfcf7d67bbd350a7f/t/60682893c386f915f4b 05e43/1617438916753/leximancer+user+guide+4.5.pdf 17. hutto cj. vader sentiment analysis. 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am, nowak da, et al. compliance with cannabis act regulations regarding online promotion among canadian commercial cannabis-licensed firms. jama netw open. 2021;4(7):e2116551. doi:10.1001/jamanetworkopen.2021.16551 28. van draanen j, krishna t, tsang c, liu s. keeping up with the times: how national public health and governmental organizations communicate about cannabis on twitter. subst abuse treat prev policy. 2019;14(1):38. doi:10.1186/s13011-019-0224-3 29. executive order 13563—improving regulation and regulatory review. published january 18, 2011. accessed october 4, 2022. https://obamawhitehouse.archives.gov/the-pressoffice/2011/01/18/executive-order-13563-improving-regulationand-regulatory-review unlock the secrets to freelance success with this 3-part on-demand video series. gain relevant and practical advice from industry pros. run your business like a pro. • essential ingredients of a successful freelance business • bad behaviors that can sabotage your business • getting the clients you deserve unlock now in amwa online learning: www.amwa.org/freelance_success http://www.amwajournal.org https://www.fda.gov/drugs/information-consumers-and-patients-drugs/importance-public-comment-fda https://www.fda.gov/drugs/information-consumers-and-patients-drugs/importance-public-comment-fda https://static1.squarespace.com/static/5e26633cfcf7d67bbd350a7f/t/60682893c386f915f4b05e43/1617438916753/leximancer+user+guide+4.5.pdf https://static1.squarespace.com/static/5e26633cfcf7d67bbd350a7f/t/60682893c386f915f4b05e43/1617438916753/leximancer+user+guide+4.5.pdf https://static1.squarespace.com/static/5e26633cfcf7d67bbd350a7f/t/60682893c386f915f4b05e43/1617438916753/leximancer+user+guide+4.5.pdf https://github.com/cjhutto/vadersentiment https://obamawhitehouse.archives.gov/the-press-office/2011/01/18/executive-order-13563-improving-regulation-and-regulatory-review https://obamawhitehouse.archives.gov/the-press-office/2011/01/18/executive-order-13563-improving-regulation-and-regulatory-review https://obamawhitehouse.archives.gov/the-press-office/2011/01/18/executive-order-13563-improving-regulation-and-regulatory-review v38 n1 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 4 the harold swanberg distinguished service award, named in honor of one of the founders of amwa, is presented to an active amwa member who has made distinguished contributions to medical communication or rendered unusual and distinguished services to the medical profession. the swanberg distinguished service award is presented during amwa’s medical writing & communication conference. i am greatly honored to even have been considered for this award, and i want to say thank you to all those involved in selecting me for it. when i received the announcement that i was getting the award, my first reaction was, “oh wow…” followed quickly by, “so, why me?” as i tried to see myself from the outside, i realized that the thing that probably makes me eligible for this award is my ongoing, almost obsessive passion for medical writing and its importance to the pharmaceutical industry and the world. science is nothing without people thinking about what it means. contrary to what people may say, data do not speak for themselves. we, as informed and skeptical creatures, look at the data and think about what they mean. as we begin to assemble each piece of insight, we put together a narrative and meaning. but that narrative only becomes powerful and has a transformative impact if it is communicated, and the knowledge is transferred from the few who are mining those nuggets of information to the rest of the world. thus, science only begets progress if it is communicated effectively, and that’s where we come in. without medical writers who understand how to take the data beyond just numbers on a page and turn it into a convincing narrative, progress will stutter. whether we are regulatory writers crafting a document that succinctly expresses to the assessors why the benefit of a drug outweighs the risk or we are in the med comms space taking the science out to the public so that people can better understand their bodies and their illnesses and the available treatments, we are bringing the message to the world. the better we do our job, the faster the messages of today will drive the science and developments of tomorrow and improve the lives of people throughout the world. we saw so clearly during the pandemic the importance of getting clear messages out to the world to avoid confusion and mistrust in science. so, i honestly do not believe it is an exaggeration when i say that medical writers bring the light to the world. hardwon light gleaned by researchers and doctors and patients who commit to research so we can learn more. but it is we who tell the world what has been learned, which is why it is our responsibility to get it right. to make sure that the texts we write are clear and focused on what matters. to ensure that no word is wasted and that we stand firm when teams start to veer toward text that merely repeats the data without any message, or long-winded, convoluted presentations for the public that confuse rather than inform. we can and must strive to show the teams we work with how much more our documents can be and why. helping them understand the “why” is the key to achieving change. julia forjanic klapproth, phd / owner and senior partner, trilogy writing & consulting gmbh, frankfurt, germany 2022 harold swanberg distinguished service award address aspire to more: raising the bar on medical writing conference http://www.amwajournal.org amwajournal.org 5aspire to more: raising the bar on medical writing and yet, curiously, i hear over and over again from medical writers how medical writers have no authority on our teams. i don’t believe that. in fact, i am of the opinion that if we believe we have no authority, we never will. having authority has to do with belief in self, in how you enter a room, in how you engage with others. first, you have to believe you are legitimate and that what you bring to the conversation is equal in value to what anyone else brings to it. but when i started out in the industry, i was afraid to speak up in meetings, afraid to ask questions. when i did, i would be so nervous that i turned beet red, and that really didn’t help my self-confidence any! but two key things helped me understand that i could and should speak up. first, i recognized something important. i noticed that when i was in meetings, i often had a question or thought about something people were discussing. but i wouldn’t speak up because i thought, well, that is so obvious; if it made any sense, the other more experienced people in the room would already have said it. right? so, i would sit in these meetings and watch conversations go around in circles, sometimes for an hour or more, and finally, somebody else would state what i thought of an hour ago or ask the question that i wanted to ask. and everybody else would go, “oh yes, exactly, that’s right!” what i realized was that maybe some of those “obvious” thoughts i was having weren’t so obvious and not so silly, and if i would only raise them as soon as i thought them, i could actually contribute meaningfully to saving us all time and making progress. but then i had to overcome my insecurity. knowing i should say something was very different than being able to say it, let alone saying it confidently and without turning into a tomato. and that was where the second thing came into play that helped me gain the courage to speak with authority. i was lucky to have a strong role model in the room with me– dr barry drees was one of the senior writers in my department, and we worked on several big projects together. if some of you are lucky enough to know barry, you will know that he can speak about anything to anyone, anywhere, at any time. and that became my goal – to speak as freely and easily as barry does. so began about a 2-year journey. the first step was recognizing that i had something to say when i was in a meeting and was literally having heart palpitations in my effort to speak about it. but i would tell myself over and over, what would barry do right now? he would be speaking. so i would think, “why aren’t you speaking? open your mouth, girl! speak!” and i would sometimes. i would turn beet red, and i was so nervous that what i said was stilted and uneven. but the more i spoke, the more people started to listen. and as i saw the impact of my input and practiced speaking up, there was a transformation, until at some point, i became the person i am now. i speak freely and frequently and have opinions on just about everything. just like barry! the reason i am telling you this is because sometimes people think when i say that medical writers can have authority if they only step up and grab it that it’s easy for me to say, or “i’m not like them.” but that’s not true. i was just lucky enough to have some good teachers and a good role model. which brings me to the relevance of this award. some of you may already know who dr swanberg was. but i suspect many of you are like i was when i found out about this award, and you don’t know much about him and his importance to our career. harold swanberg was not only one of the founders of amwa, he was an outspoken supporter of improving the education at all levels – from schoolchildren to medical writers, believing that offering everyone the opportunity of a good education would help society overall by helping people find fulfilling careers best suited to their abilities and predilections. he cofounded the amwa educational committee in 1951, which focused on creating an appropriate curriculum for undergraduate and graduate programs in medical writing and editing. he also launched a manuscript editing service through amwa to help physicians improve their documents. dr swanberg not only understood that there was a need for people to assist physicians in communicating their findings but that we should be cultivating this function as a career. i personally connect strongly with dr swanberg's vision to create a curriculum for training medical writers. without our teachers and role models, only a very few will find success and fulfillment. while dr swanberg brought  i personally connect strongly with dr swanberg’s vision to create a curriculum for training medical writers. without our teachers and role models, only a very few will find success and fulfillment. http://www.amwajournal.org amwajournal.org 6aspire to more: raising the bar on medical writing the idea to life of teaching people the essentials of medical writing in an editorial function, today the role of a medical writer has matured into much more. we are communicators, cat herders, solution finders, and leaders. our training programs must serve all these areas, including teaching each one of us to believe in ourselves and not shy away from guiding our teams to producing documents that really communicate effectively. medical writing is coming of age, and tailored, effective training is essential to raise the bar on the role and perception of medical writers in our industry. so, to wrap up, i have to say that i am a bit dazed by getting this award. to be honored by your peers is incredibly rewarding, and i am very thankful for that recognition. but i accept this award with humbleness, for i stand on the shoulders of giants. from the inspired and tireless efforts of dr swanberg through the generations of champions of the medical writer’s cause, i simply carry the torch further. i will do what i can to live up to what this award stands for. thank you. acknowledgment i thank stephanie vargas, md, principal and medical director, med ink consulting, for her help in bringing the transcript to the page. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. www.amwa.org/mwc three little letters. one big deal. apply now apply by april 18 for june 2023 exam. review our applicant handbook, candidate guide, and study tips to help you prepare. http://www.amwajournal.org v37 n3 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 4 abstract medical communicators are professionals with a knowledge of both medicine and writing who are able to deliver complex scientific information to a variety of audiences. as the leading professional organization for medical communicators with a membership of nearly 5,000, the american medical writers association (amwa) is well-situated to tap into their member network to better understand the diverse backgrounds and experience of medical communicators. in this article, amwa presents the demographic data (eg, age, gender, education, and work experience) received from the medical communication compensation survey to create a snapshot of the medical writing community. amwa emailed the most recent web-based survey to medical writers and editors during the first quarter of 2019. overall, 7,456 individuals received the survey, and 1,418 respondents completed the survey. about twothirds (66.1%) of the respondents were employed by a company, similar to the 2015 survey (65.1%), whereas the remaining one-third were freelancers. most respondents were female (83.4%), and the average age of all respondents was about 48 years. the average time spent working for pay as a medical communicator for all respondents was 12 years. most respondents held a doctoral-level degree (46%) or a master’s degree (32%) as their highest level of education. nearly half of all respondents had their highest degree in the field of science (47.2%), whereas 9% had their highest degree in english. a key takeaway from the survey is that medical communicators are a highly educated group of professionals, indicating a commitment to continuous learning. amwa members are encouraged to keep their member profiles up to date to provide additional demographic information to support amwa’s mission of promoting excellence in medical communication and providing educational resources in support of that goal. elizabeth kukielka, pharmd, ms, mwc / senior medical writer, citrus health group, philadelphia, pa amwa: who we are feature medical communicators are professionals with a knowledge of both medicine and writing who are able to deliver complex scientific information to a variety of audiences, such as health care providers, patients and their caregivers, industry professionals, and public policy officials. individuals working in the field of medical communication may have such titles as medical editor, medical writer, scientific writer, technical writer, regulatory writer, promotional writer, and health care journalist, among many others. medical communicators are responsible for the development of materials in formats ranging from print publications to digital media, and some examples of their work include abstracts and posters for scientific conferences, grant proposals, health education materials, science textbooks, continuing education materials for health care professionals, sales training materials for pharmaceutical or medical device representatives, and regulatory documents for submission to health agencies. as the leading professional organization for medical communicators in the united states and worldwide with a membership of nearly 5,000, the american medical writers association (amwa) is well-situated to tap into their member network to better understand the diverse backgrounds and experience of medical communicators. one valuable information source is the medical communication compensation survey conducted periodically by amwa. this survey provides dependable salary information upon which employers and employees in the field of medical communication can base their salary negotiations. in addition to details about compensation, the survey also collects a wealth of demographic data from respondents, including age, gender, education, and work experience. in the following pages, amwa presents the demographic data received from the survey to create a snapshot of the medical writing community. methods amwa has been conducting periodic compensation surveys since 1989, and the most recent survey was deployed http://www.amwajournal.org amwajournal.org 5amwa: who we are to medical writers and editors during the first quarter of 2019. the purpose of the survey was to determine prevailing annual income and fee levels and to study different factors affecting pay (eg, years of experience, education, certification, employer type, type of work, and position level), based on the results of previous surveys. a web-based survey was emailed to 7,456 individuals (3,835 amwa members and 3,621 nonmembers). nonmembers included lapsed amwa members as well as individuals who were never amwa members. among those, 271 people requested to be removed from the survey panel and 55 emails were returned, bringing the revised total number of respondents to 7,130. the survey included a question about whether people had worked for pay as a medical communicator during 2018 so that individuals who did not work in the field within the time window of interest could be excluded. results overall, 1,418 individuals completed the survey, yielding a response rate of 20% and showing an increase in participation from the 2 previous surveys deployed in 2011 and 2015 (table 1). more than four-fifths of respondents (81.3%) table 1. demographics at a glance for all respondents, 2007–2019 1133 all respondents all respondents: demographics the majority of medical communicators responding to the 2019 survey were females (83.4%). the average age was approximately 48 years, and the average number of years working for pay as a medical communicator was 12. about one-third of respondents held a phd (37.4%) or a master’s degree (31.6%) as their highest level of education, more than three-fourths (77.4%) did not have an amwa essential skills certificate, and four in 10 (41.1%) had the els (editor in life sciences) certification. approximately half of all the respondents had their highest degree in the field of science (47.2%) while 9.0% had their highest degree in in english, quite similar to the proportions observed in the 2015 survey. as shown below, respondent demographics in the 2019 survey were similar to those reported in the 2015 survey. 2007 2011 2015 2019 all respondents 1704 1193 1292 1418 employee 1183 819 841 938 freelance 521 374 451 480 employee/freelance --104 109 female 83% 84% 85% 83% male 17% 16% 15% 16% prefer not to answer ---1% age (mean) all employee 44 45 45 46 freelance only 48 50 50 52 <2 14% 11% 8% 7% 2-5 20% 20% 25% 26% 6-10 28% 25% 25% 19% >10 38% 43% 42% 49% all employee 9 11 11 11 freelance only 13 15 17 15 bachelor's 36% 28% 21% 21% master's 34% 34% 32% 32% advanced degree 30% 38% 40% 46% science includes biology, medical technology, health sciences, and nutrition 40% 44% 50% 47% english --9% 9% medicine 4% 4% 5% 5% pharmacy 5% 5% 4% 5% journalism 5% 5% 4% 4% communications 4% 4% 4% 3% liberal arts 11% 11% 4% 3% medical writing --4% 2% years of medical writing experience (mean) % highest level of education % field of highest degree all respondents'' demographics: 2007-2019 number of respondents gender % years of medical writing experience http://www.amwajournal.org amwajournal.org 6amwa: who we are reported that they were amwa members. about two-thirds (66.1%) of the respondents were employed by a company, similar to the 2015 survey (65.1%), whereas the remaining one-third were freelancers (table 2). when asked to describe their employer, 19.4% of all employee respondents indicated they had worked for a pharmaceutical company, 14.4% had worked for a medical communication company, and 13.8% had worked for a clinical or contract research organization. most employee respondents indicated that the main area in which they had worked was regulatory writing (40.8%) or scientific publication (24.8%). most respondents were female (83.4%) (table 1). the average age of all respondents was about 48 years. the average age for employees was 46 years, whereas for freelancers it was 52 years. more than half of respondents were 45 years or older, and only 12.6% were younger than 35 years (figure 1). the average time spent working for pay as a medical communicator for all respondents was 12 years. nearly half (48.9%) of all respondents had greater than 10 years of experience as a paid medical communicator (figure 2), with an average of 12.4 years. employees averaged 10.9 years of experience, whereas freelancers averaged 15.4 years. most respondents held a doctoral-level degree (46%), such as a phd, md, or pharmd, or a master’s degree (32%) as their highest level of education (figure 3). these percentages were similar between employees and freelancers. nearly half of all respondents had their highest degree in the field of science (47.2%), which included biology, chemistry, medical technology, health sciences, and nutrition, whereas 9% had their highest degree in in english; these proportions were similar to those observed in the 2015 survey. employees (50.4%) more often had their highest degree in science than freelancers (41 %) (table 3 on next page). overall, about one-fifth of respondents (22.6%) held the amwa essential skills certificate. among all respondents, the certificate was held for an average of 8.6 years. freelance respondents (10.4 years) held the certificate longer on average than employees (7.6 years). when asked about certifications, 41.1% of respondents reported they held the editor in the life sciences (els) certification, 17.2% held the certified medical publication professional certification, 11.7% held the medical writer certified table 2. type of employment, 2015 and 2019 figure 1. age of all respondents, 2019. n= 1,394. source: amwa 2019 compensation survey. figure 2. years of experience as a medical communicator for all respondents, 2019. n= 1,414. source: amwa 2019 compensation survey. figure 3. highest level of education for all respondents, 2019. n= 1,415. source: amwa 2019 compensation survey. 1144 an online survey was used to collect responses from amwa members and nonmembers. overall, 1,418 responses were received of which about four-fifths (81.3%) responded that they were members. about two-thirds (66.1%) of the respondents were employees, similar to their share in the 2015 survey (65.1%). nearly half (48.9%) of all respondents had greater than 10 years of experience as a paid medical communicator, with an average of 12.4 years. employees averaged 10.9 years of experience while freelances averaged 15.4 years. slightly more than eight in 10 respondents were amwa members. more than half (54.6%) reported that they had not completed the amwa salary survey in 2015, while 22.3% reported that they had completed it; 23.1% did not remember. approximately two-thirds of respondents were employees and one-third were freelances. more than half of the response pool was 45 years or older; only 12.6% were younger than 35 years. amwa membership all respondents yes 81.3% no 18.7% source: amwa 2019 compensation survey n=1,404 employment status all respondents employee 66.1% freelance 33.9% source: amwa 2019 compensation survey n=1,418 employees 938 66.1% 841 65.1% freelance 480 33.9% 451 34.9% freelance employees 109 11.6% 104 13.8% percentage of employees and freelances are based on total respondents percentage of freelance employees is based on count of employees 2019 2015 survey participants: 2015 & 2019 1144 an online survey was used to collect responses from amwa members and nonmembers. overall, 1,418 responses were received of which about four-fifths (81.3%) responded that they were members. about two-thirds (66.1%) of the respondents were employees, similar to their share in the 2015 survey (65.1%). nearly half (48.9%) of all respondents had greater than 10 years of experience as a paid medical communicator, with an average of 12.4 years. employees averaged 10.9 years of experience while freelances averaged 15.4 years. slightly more than eight in 10 respondents were amwa members. more than half (54.6%) reported that they had not completed the amwa salary survey in 2015, while 22.3% reported that they had completed it; 23.1% did not remember. approximately two-thirds of respondents were employees and one-third were freelances. more than half of the response pool was 45 years or older; only 12.6% were younger than 35 years. amwa membership all respondents yes 81.3% no 18.7% source: amwa 2019 compensation survey n=1,404 employment status all respondents employee 66.1% freelance 33.9% source: amwa 2019 compensation survey n=1,418 employees 938 66.1% 841 65.1% freelance 480 33.9% 451 34.9% freelance employees 109 11.6% 104 13.8% percentage of employees and freelances are based on total respondents percentage of freelance employees is based on count of employees 2019 2015 survey participants: 2015 & 2019 55 years or older 31.6% younger than 35 years 12.6% 35–44 years 30.2% 45–54 years 25.5% 1144 an online survey was used to collect responses from amwa members and nonmembers. overall, 1,418 responses were received of which about four-fifths (81.3%) responded that they were members. about two-thirds (66.1%) of the respondents were employees, similar to their share in the 2015 survey (65.1%). nearly half (48.9%) of all respondents had greater than 10 years of experience as a paid medical communicator, with an average of 12.4 years. employees averaged 10.9 years of experience while freelances averaged 15.4 years. slightly more than eight in 10 respondents were amwa members. more than half (54.6%) reported that they had not completed the amwa salary survey in 2015, while 22.3% reported that they had completed it; 23.1% did not remember. approximately two-thirds of respondents were employees and one-third were freelances. more than half of the response pool was 45 years or older; only 12.6% were younger than 35 years. amwa membership all respondents yes 81.3% no 18.7% source: amwa 2019 compensation survey n=1,404 employment status all respondents employee 66.1% freelance 33.9% source: amwa 2019 compensation survey n=1,418 employees 938 66.1% 841 65.1% freelance 480 33.9% 451 34.9% freelance employees 109 11.6% 104 13.8% percentage of employees and freelances are based on total respondents percentage of freelance employees is based on count of employees 2019 2015 survey participants: 2015 & 2019 >10 years 48.9% 2–5 years 25.8% 6–10 years 18.7% <2 years 6.5% 1155 the average age for employees was 46 years and about 52 for freelances. freelances also had more years of experience as paid medical communicators than employees—15.4 years and 10.9, respectively. as their highest level of education obtained, one-fifth of the respondents had a bachelor’s degree and 46.0% had an advanced degree (phd+other advanced degree). these percentages were not different between employees and freelances. employee freelance 2019 46.0 51.5 2015 44.9 50.1 2019 10.9 15.4 2015 10.8 16.6 all respondents age and years of experience: 2015 & 2019 age (mean) years of experience (mean) note there was a slight difference in the wording of the question for experience from one survey wave to the next associate's degree or less and other bachelor's degree master's degree advanced degree* count all respondents 1.7% 20.7% 31.6% 46.0% 1,415 employee 1.6% 21.0% 32.0% 45.4% 937 freelance 2.1% 20.1% 30.8% 47.0% 478 all respondents highest level of education: 2019 *advanced degree includeds phd, md, pharmd, and other advanced degree other 1.8% other advanced degree 8.6% phd 37.4% bachelor's degree 20.7% master's degree 31.6% http://www.amwajournal.org amwajournal.org 7amwa: who we are certification, and one-third of respondents held other certifications (figure 4). the els was held most often by those having a bachelor’s degree as their highest degree (51.5%). more than two-fifths of respondents (44.1%) had worked in regulatory writing in the pharmaceutical, biotechnology, or device industry during their career. of those who worked in regulatory writing, 77.7% had written clinical study reports (csrs), 74.4% had written study protocols, 64.7% had written investigator brochures, 63.5% had written regulatory responses or briefing documents, and 60.0% had written summary documents for supplemental drug submissions during their career (figure 5). on average, a medical communicator who had worked in regulatory writing had written 32.8 nonclinical/discovery and chemistry, manufacturing, and controls (cmc) documents, 28.3 csrs, and 28.3 study protocols during their career. on average, freelance respondents had written more csrs, study protocols, investigator brochures, and summary documents for drug submissions in their careers than their employee counterparts, whereas employees had written more nonclinical/discovery and cmc documents and aggregate reports than freelance respondents. conclusions one key takeaway from amwa’s medical communication compensation survey is that medical communicators are a highly educated group of professionals, with nearly half of respondents reporting that they have an advanced degree. the high level of education among amwa members and other medical communicators indicates a commitment to continuous learning. a new content strategy plan was developed following the 2019 survey with goals that included aligning amwa’s educational offerings with the needs of the membership and fulfilling amwa’s mission. in developing the content strategy, amwa relied on data from the compensation survey, other surveys of the membership, and other data sources. one critical data source is the demographic information collected through amwa member profiles, such as gender, race, highest level of education, primary workplace, and areas of professional focus. these online profiles may be accessed by members nearly half the respondents (47.2%) indicated science as the field of their highest degree followed by english (9.0%). employees were more likely to have their highest degree in science than freelance respondents—50.4% compared to 41.0%. overall, only one-fifth (22.6%) held the amwa essential skills certificate. of those respondents, on average, the certificate was held for 8.6 years. freelance respondents who earned the amwa essential skills certificate have held it, on average, for 10.4 years, and employees who earned it have held it, on average, for 7.6 years. all respondents (1,418) employee (938) freelance (480) business 2.2% 2.0% 2.5% communication 3.0% 3.2% 2.5% education 1.2% 1.2% 1.3% english 9.0% 9.6% 7.9% health care administration 0.5% 0.6% 0.2% journalism 3.5% 3.4% 3.8% liberal arts 2.9% 3.0% 2.7% medical writing 2.1% 1.9% 2.5% medicine 5.3% 3.8% 8.1% nursing 1.6% 1.0% 2.7% pharmacy 5.3% 4.4% 7.1% public health 3.5% 3.6% 3.1% science includes biology, chemistry, health science, medical technology, and nutrition 47.2% 50.4% 41.0% technical writing 1.8% 1.5% 2.3% other 11.0% 10.3% 12.3% all respondents fields of highest degree: 2019 amwa essential skills certificate all respondents yes 22.6% no 77.4% source: amwa 2019 compensation survey n=1,405 table 3. field of highest degree, 2019 when asked about certifications, two-fifths (41.1%) of respondents held the els certification and onethird held “other” certifications. the cmpp was earned by 17.2% of all respondents and 11.7% held the mwc. the els was held more often by those having a bachelor’s degree as their highest degree (51.5%). more than eight in 10 respondents were female and 16.0% were male. less than 1% answered that they preferred not to answer this question. more than four in 10 respondents (44.1%) had worked in regulatory writing in the pharmaceutical, biotechnology, or device industry during their career. gender all respondents female 83.4% male 16.0% prefer not to answer 0.6% source: amwa 2019 compensation survey n=1,409 have worked in regulatory writing in pharmaceutical, biotechnology or device industry all respondents yes 44.1% no 55.9% source: amwa 2019 compensation survey n=1,418 certifications all respondents 2.9% 5.5% 11.7% 17.2% 33.3% 41.1% chcp (certified healthcare professional) rac (regulatory affairs certification) mwc (medical writer certified) cmpp (certified medical publication professional) other certificates els (editor in the life sciences) 0.0% 10.0% 20.0% 30.0% 40.0% 50.0% source: amwa 2019 compensation survey n=384figure 4. certifications for all respondents, 2019. n= 384. source: amwa 2019 compensation survey. http://www.amwajournal.org amwajournal.org 8amwa: who we are of those who worked in regulatory writing, about three-fourths had authored clinical study reports (77.7%) and study protocols (74.4%), and around six in 10 had authored investigator brochures (64.7%), regulatory responses or briefing documents (63.5%), and summary documents for new or supplemental drug submissions (60.0%) during their career. on average, a medical communicator who had worked in regulatory writing would have authored 32.8 nonclinical/ discovery and cmc documents and 28.3 study protocols or clinical study reports during their career. on average, freelance respondents have authored more clinical study reports, study protocols, investigator brochures, and summary documents for new or supplemental drug submissions in their careers than their employee counterparts, whereas employees have authored more nonclinical/ discovery and cmc documents and aggregate reports than freelance respondents. when asked to describe their employer in 2018, one-fifth (19.4%) of all employee respondents indicated working for a pharmaceutical company, and one in seven worked for a medical communications company (14.4%) or a clinical or contract research organization (13.8%). four in 10 employee respondents (40.8%) indicated that the main area in which they work was regulatory writing, and about one-fourth (24.8%) worked in scientific publications. likewise, one-fifth of all freelance respondents said that the client providing the highest percentage of their income was a medical communications company (21.7%) or a pharmaceutical company (19.1%). as for the area of work earning the greatest percentage of income, nearly a quarter of all freelances selected regulatory writing (23.4%) followed by scientific publications (21.0%). 20.6% 32.2% 35.3% 60.0% 63.5% 64.7% 74.4% 77.7% aggregate reports (generally postmarketing) nonclinical/discovery and cmc documents other document summary documents for new or supplemental drug submissions regulatory responses or briefing documents investigator brochures study protocols clinical study reports 0.0% 20.0% 40.0% 60.0% 80.0% 100.0% 12.2 n=302 28.3 n=337 16.2 n=283 18.7 n=292 32.8 n=145 17.2 n=86 28.3 n=354 no. of documents (average) source: amwa 2019 compensation survey n=583 *check all applyfigure 5. documents authored during career for all respondents who had worked in regulatory writing, 2019 (check all that apply). n= 583. cmc=chemistry, manufacturing, and controls. source: amwa 2019 compensation survey. at any time by logging into the amwa website. by keeping member profiles up to date, members can support amwa’s mission of promoting excellence in medical communication and providing educational resources in support of that goal. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: ekukielka@citrushealthgroup.com keep your amwa member profile up to date. help us understand more about you! what best describes your role as a medical writer? how would you describe your primary workplace/client? what is your primary professional area of focus? what are your additional professional areas of focus? what is your primary responsibility in your work? where do you live (city, state, country)? what is the highest level of education completed? what credentials or degrees do you have? which gender do you identify with? what is your race/ethnicity? what is your year of birth? log into www.amwa.org and update your profile today. http://www.amwajournal.org v37 n4 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 4 over the past eight decades, the role and perceived value of what we’ve come to know as the medical writer has evolved. as the process of document production became more complicated and time-consuming, a separate group of specialists evolved to serve the role of “medical writer.” although this role may not have been formally defined, and certainly not consistently so, this was the genesis of the professional we consider to be the medical writer. when amwa was founded, members were physicians who wrote. the documents that they generated were primarily manuscripts for publication, content for medical textbooks, and, perhaps, case studies. in 1940, there were only rudimentary documents created for submission to a fledgling food and drug administration. indeed, regulations, as we know them, had not yet been formulated. as regulatory document requirements became more structured and went beyond case study descriptions, expertise had to be expanded from medical and scientific knowledge to an understanding of what would satisfy the requirements of regulators—requirements that were constantly evolving and becoming more stringent. at the same time, there was a move toward globalization and the need to serve at least two masters—fda, the european medicines agency (ema), the japanese pharmaceutical and medical devices agency (pmda), etc. the world of publications has, likewise, undergone significant changes. at the outset, the end product was printed hard-copy articles in medical and scientific journals, the majority of which were only available by subscription to those with advanced degrees in the life sciences or to physicians. for most of the profession’s history, there was no internet and, therefore, no access by the general public to this information. we now live in a technologically enabled environment where information is posted online, often unvetted, and assumes a life of its own—freely distributed, manipulated, misinterpreted, and all too often “weaponized.” through the years, the role of the medical writer was often determined by corporate, or even team, culture. depending upon the experiences, inherent biases, and personalities of your team members, the medical writer was viewed as a secretary, editor, wordsmith, or valued interpreter of data and expert communicator. in preparing for this special topics edition of the amwa journal, i wanted to tap into a broad and varied spectrum of those who practice the trade of professional medical writing as well as some who collaborate with them. in eliciting thoughts, i decided to create a series of virtual panels, thus allowing for a more conversational and interactive experience among participants. what has resulted is a series of collective thoughts on where the profession is going, and which forces will shape the context within which we will ply our trade going forward. in one case, individuals formed their own “panel of one”; however, panels mostly comprised colleagues either from the same company or those who were invited because they were members of a particular professional organization (eg, the drug information association (dia)) or represented a particular viewpoint within the medical writing community. i provided a framework for the panel discussions, based on my 2020 “crystal ball” predictions, on the occasion of amwa’s 80th year. i posited that the environment—scientifically, technologically, socially, and politically—will continue to evolve, although inexorably toward what end, it is impossible to divine. my musings, below, apply to all segments of the medical communications community—regulatory medical writers, information specialists, publication professionals, teaching faculty…and others who represent the broad spectrum under the medical writing umbrella. contributors were asked to choose one or more of the topics presented below and to share their perspectives, either as a consensus or as individual observations. the suggested overarching themes and subtopics follow; however, panelists tended to free-associate, and although some of the suggested topics were addressed, panelists sometimes elected to discuss topics of particular interest to them. art gertel, phd / medscicom, llc, white house station, nj the future of medical writing: gazing into the crystal ball from the guest editor http://www.amwajournal.org amwajournal.org 5the future of medical writing: gazing into the crystal ball technology • there will certainly be an increased use of artificial intelligence, automated templates, and esubmissions to regulatory authorities. • data will become more available in real time as clinical studies leverage personal data interfaces, including “wearables” or even “implantables.” this may result in the medical writer accessing, aggregating, interpreting, and communicating trends and signals throughout the course of a study, rather than only at the point of last patient, last visit. • the current coronavirus pandemic has accelerated the work-from-home model. technology will continue to enhance this practice, removing many of the barriers and inconveniences we now face. it may become an opportunity to be a “work-from-home planet.” what about the audience? • information may be provided to a broader range of consumers. no longer will results of studies be limited to regulators and scientific/medical cognoscenti. with greater access to posted documents in a variety of portals, the public will seek and access information that is important for informed decision-making. the patient will have a stronger voice in determining their treatment, and this will extend to end-of-life decisions. social media will amplify results and will spread misinterpretations and poor quality data. caveat emptor ! role expansion • medical writers will assume a stronger role as “guardians” of best practices. not only do regulations constantly evolve, but so do publication practices. the medical writer will have to maintain a high level of awareness and familiarity with current best practices and will have to serve as a “gatekeeper” to best ensure that these are not violated. this will require that the medical writer assume the role of educator, communicating the essence of these standards and the rationale for adhering to them. globalization • a single global regulator? not likely, but a lot can happen in 80 years. the trend toward mutual recognition among regulators will continue, with common guidance and templates. yes, there will still be regional differences; however, the core dossier will serve all masters. • our professional associations (eg, amwa, emwa, ismpp, etc) have represented a “balkanized” community, despite the significant overlap in membership profiles, educational program content, and common interests and goals. recently, the three organizations mentioned have successfully collaborated to develop joint position statements addressing systemic and institutional deficiencies. i trust that this will continue and hope that at some point, we will realize that we have a stronger voice through alliances not just within the medical writing community but with associated institutions (eg, academia, medical and scientific journals, regulators, etc). i have long been an advocate for the intergalactic medical writers association. perhaps, one day! other thoughts • pressure to release data in “real time” for publication – technology allows us to do so, particularly given the increase in use of patient-reported outcome platforms that gather data in real time and adapt to prior responses. this allows the release of “raw data” that may have been only minimally vetted. • society will determine that resources are insufficient to provide all services to all patients. this rationing of health care may seem draconian; however, in a world of limited resources, algorithms will be applied to human healthcare. this will result in a greater need for medical communicators to develop materials to educate the public, including lawmakers, about the rationale for allocation decisions. the panels represented participants from across the globe, and i thank them for their insightful observations and suggestions as to how the profession might best confront unmet needs, opportunities for growth, and the challenges that have been long-standing, are only recently emerging, or that we may imagine in a cloudy future. the future will reveal itself over time. as one of my heroes, that great sage, yogi berra, likely said, “it's tough to make predictions, especially about the future.” author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. the author has met all of the authorship criteria recommended by the international committee of medical journal editors (icmje). author contact: medscicom@rcn.com http://www.amwajournal.org v37 n4 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 35 it’s a rather tacit revolution that happened on september 26, 2022, in the “what’s new” section of the https://clinicaltrials.gov website. a short announcement states that “a plain language checklist for lay brief summaries (pdf) is added to the support materials under data element definitions, templates, and checklists. the checklist identifies plain language best practices to help investigators write brief summaries that can be easily understood by the general public.” this unemotional announcement is a tremendous move toward more understandable entries in clinicaltrials.gov (ct.gov)—that is, a move returning to ct.gov’s original intentions. the purpose of ct.gov was to make information on clinical trials available to the public, initially to “individuals with serious or life-threatening diseases or conditions, to other members of the public, to health care providers, and to researchers.”1 hosted by the national library of medicine, ct.gov was to be a “consumer-friendly” database that provides easy access to information about clinical trials for patients and their families and members of the public.2 in 2007, by the us food and drug administration amendment act (fdaaa), the mandatory registration of clinical trials was complemented with the requirement to make full trial results available.3 however, over the years, ct.gov moved further and further away from its initial intentions and became a website for pharma companies’ transparency experts, competitive intelligence analysts, investors, and clinical trial aficionados. this development was a consequence of the technical operationalization of the transparency regulations without having the end user in mind. responding to the growing disconnect between intention and status, ct.gov has in 2019 initiated a modernization effort with the objective to “deliver an improved user experience.” to foster the overarching objective of transparency of clinical trial research activities, more and more information is to be provided by sponsors and investigators about their clinical trials. the information itself is—however—not presented in a way that “normal people” can readily understand. the disconnect between intention and current practice is particularly obvious for 2 data fields that are of great importance to patients: the brief title, a short title describing the trial, and the brief summary, a short summary that is meant to provide a general, high-level overview of the trial. as per ct.gov guidance,4,5 the text that sponsors are to enter in these data fields needs to be in lay language; that is, it needs to be understandable for the public. despite ct.gov’s intentions, sponsors have not lived up to this.6,7 to the contrary, brief titles are often full of abbreviations and specialist language that renders them incomprehensible for most members of the public. this also applies to the brief summaries, which should provide a short, high-level summary of the clinical trial detailing its goal and the intended indication. from a patient view, this is particularly unhelpful as the ct.gov website returns a list of study titles as a response to a search request (eg, trials in a disease area). thus, the interested user is provided with a list of study titles that mean little to them because they often lack the specialthomas m. schindler, phd / biontech se and lay & regulatory writing, mainz and biberach a. d. riss, germany on to the next level: clinicaltrials.gov goes (more fully) plain! topical feature http://www.amwajournal.org https://clinicaltrials.gov amwajournal.org 36on to the next level: clinicaltrials.gov goes (more fully) plain! ist knowledge to fully understand them. furthermore, if the user then clicks on a title, they are shown the brief summary, which should ideally provide key information about a trial in understandable language. however, the user is often provided with a paragraph of clinical trial gobbledegook and insider technical slang written for the fellow specialist. prior to the september announcement, ct.gov had supplied very little guidance on the content of brief summaries; therefore, the new guidance amounts to a major improvement. by explicitly providing a plain language checklist, ct.gov reemphasizes the requirement that these key data fields need to be understandable to patients and the public. should all go well and sponsors do implement the new guidance, key entries of ct.gov will become a lot more accessible for the public—a true revolutionary development, as the database gains a lot more usability for everybody. for people familiar with plain language writing, the checklist provided is unspectacular and summarizes the most important points of writing in plain language. although ct.gov addresses the checklist to study managers and investigators, the task of developing useful study titles and understandable study descriptions is better handled by professional writers even better by professional writers with expertise in plain language writing.8 as anybody who wants to have a go will quickly find out, it is a challenge to provide good study titles and even more so to provide a good, useful study description. it is an even greater challenge doing this in a systematic way across different disease areas in the context of a larger company or research institution. few study managers would identify patient-focussed writing as one of their core competencies. hence, the new focus of ct.gov on plain language writing opens a new realm of activity for professional medical writers, particularly those with plain language writing expertise. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: lay_and_regulatory_writing@gmx.de or thomas.schindler@biontech.de references 1. food and drug administration modernization act (fdama) of 1997. pub l no. 105-115 (november 21, 1997). 2. press release: national institutes of health launches “clinicaltrials.gov." national institutes of health. published february 29, 2000. accessed november 9, 2019. https://www.nlm. nih.gov/archive/20040831/news/press_releases/clntrlpr00.html 3. food and drug administration amendments act (fdaaa) of 2007. pub l no. 110-185 (september 27, 2007). 4. clinicaltrials.gov prs. bethesda: u.s. national library of medicine. protocol registration data element definitions for interventional and observational studies [updated march 7, 2019]. https://prsinfo.clinicaltrials.gov/definitions.html 5. clinicaltrials.gov prs. bethesda: u.s. national library of medicine. protocol registration and document upload quality control review criteria [june 27, 2018]. https://prsinfo. clinicaltrials.gov/protocoldetailedreviewitems.pdf 6. viergever rf, karam g, reis a, ghersi d. the quality of registration of clinical trials: still a problem. plos one. 2014;9(1):e84727. 7. schindler tm, grieger f, zak a, et al. patient preferences when searching for clinical trials and adherence of study records to clinicaltrials.gov guidance in key registry data fields. plos one. 2020;15(5):e0233294. 8. leithold lhe, brown cm, schindler tm. lay titles for clinical trials: a balancing act. med writing. 2018;27(2):55-58. general principles of word usage www.amwa.org/online_learning choose the right word for accuracy and clarity. http://www.amwajournal.org https://www.nlm.nih.gov/archive/20040831/news/press_releases/clntrlpr00.html https://www.nlm.nih.gov/archive/20040831/news/press_releases/clntrlpr00.html https://prsinfo.clinicaltrials.gov/definitions.html https:// prsinfo.clinicaltrials.gov/protocoldetailedreviewitems.pdf https:// prsinfo.clinicaltrials.gov/protocoldetailedreviewitems.pdf american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. v38 n3 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 14 theme article abstract although access to scientific information has improved for the general public since the introduction of plain language summaries (plss) and the open-access publishing movement, language barriers still impede the widespread dissemination of information. most scientific articles are published in english language only, despite english speakers comprising just 17% of the world’s population. here we present a pilot analysis that aimed to compare the translation quality of plss and abstracts translated by a selected browser-based translation software. we translated abstracts and plss from 5 medical journal publications into french, german, mandarin, and slovenian using google translate. four bilingual reviewers with a scientific background assessed the translation quality using pre-defined survey questions that covered the appropriateness of word/phrase selection, grammar, and clarity. we assessed the number of errors of each type and used a 5-point likert scale to measure the impact of these errors on the meaning of the text. translations of both plss and abstracts were considered accurate and readable, although plss scored higher across most measures. for overall accuracy, translated plss scored higher on the likert scale than translated abstracts (mean, 4.60 vs 4.30, respectively), with 60% of pls translations considered to be “very accurate” compared with 45% of abstract translations. plss were also considered less likely to be misinterpreted (mean, 4.55 vs 4.25, respectively), with 60% of pls translations compared with 45% of abstract translations reported as “definitely not” likely to be misinterpreted. based on our findings, google translate potentially offers a quick and easy approach to translating scientific/medical information summaries for non-english speakers. however, before these articles can be translated, they must be discoverable by non-english speakers. engagement and collaboration with medical publishers are needed to improve access for non-english speakers, including provision and pubmed indexing of plss that can be translated easily. plain language summary articles that report results from scientific studies are often written in technical language that can be difficult to understand. scientific articles usually begin with a short summary, called an abstract. sometimes, plain language summaries (plss) are also available which are written using straightforward language. the aim of including a pls is to make sure that the scientific information can be understood easily by the general public. however, there is another language barrier that can make it difficult for people to read scientific articles: most are only written in english. specialist services can be used to translate articles into other languages, but this can be expensive and time consuming and so is not done often. in our study, we measured how well a free, online translation tool (google translate) could translate plss and abstracts from 5 english-language articles into french, german, mandarin, and slovenian. four people who spoke english and one of the 4 languages read the translations and answered a survey about the translation quality. overall, translations of both plss and abstracts were accurate and easy to read, but pls translations were slightly better than abstract translations across all the measures. the results of our study show that google translate offers a free, quick, and easy way to accurately translate summaries of scientific information which could help people who do not speak english to understand the information. importantly, before articles can be translated, non-english speakers need to be able to find them. to improve access to scientific articles, we suggest that scientists work with publishers to increase the number of articles that have plss, and to make sure that these can be found easily by people who do not speak english. background accessibility of scientific information is an ongoing topic of discussion. most scientific articles are written in technical language, which is not easily understood by all readers and is a barrier to the widespread accessibility of scientific information. in fact, evidence suggests that scientific literature claire beeby1; eleanor j. raynsford, phd2; and charles pollitt, phd2 / 1oxford pharmagenesis ltd, london, united kingdom; 2ipsen, slough, united kingdom science without borders – can translation tools bridge the language gap? http://www.amwajournal.org amwajournal.org 15science without borders – can translation tools bridge the language gap? is becoming less easy to understand, with long words, long sentences, and jargon preventing easy comprehension.1 this is counterintuitive given the current focus on making science accessible to all. the proportion of freely available scientific literature has continued to grow since open access publishing was proposed 20 years ago,2,3 but if the average reader cannot easily understand the information, these efforts seem hollow. plain language summaries (plss) offer a solution to this problem, and are increasingly popular with the aim of supporting nonspecialists (as well as timepoor readers) to understand the content of research articles easily, thereby further enhancing research accessibility.1 although the volume of freely available scientific literature is increasing, as well as the number of articles that include plss, the proportion of articles published in languages other than english is decreasing. in the early 1900s, around one-third of scientific articles were written in english.4 this had risen to around three-quarters of scientific articles published in english by 2013.4 however, around 83% of the world’s population is non-english speaking, leaving a huge accessibility gap for both lay people and the scientific community.4 to close this gap, there is a need to improve accessibility of medical information for non-english speaking physicians, researchers, policymakers, patients, and caregivers. physicians who do not speak english may be at a disadvantage if they do not have timely access to important scientific information in their own language, for example results of clinical trials. physicians who speak english as a second language may also find it harder to understand5 or remember6 scientific information that they have read in english than information supplied in their native language. even high-profile research funded by non-english speaking governments is likely to be published in english, limiting accessibility within its country of origin if no translation is provided.7 although specialist translation services offer high-quality translations of scientific text, time and cost may be barriers for most individuals and organizations to get articles they want to read translated regularly. browser-based translation tools offer the potential for quick, easy, and free-of-charge translation of scientific articles. free translation tools are largely trained on nontechnical language rather than scientific literature, and so may not translate scientific articles as clearly or accurately as plain language text.8 although abstracts provide a convenient condensed summary of a scientific article’s content, most are written in highly technical language. the rise in popularity of plss may therefore allow for enhanced access to scientific information for non-english speakers, provided that browser-based tools can accurately translate these summaries. in august 2022, we performed a pilot analysis comparing the quality of translation of plss and scientific abstracts when carried out using a selected browser-based translation software. this analysis was presented as a poster at both the european and annual meetings of the international society for medical publication professionals (ismpp) in 2023.9,10 methods we selected 5 ipsen-sponsored articles with accompanying plss for translation (figure 1).11-15 our decision to use articles and plss from a single source was designed to limit any impact of differences in the quality of written english in figure 1. study design. pls, plain language summary. aipsen-sponsored publications were selected because they were readily accessible and known to have both abstracts and plss. blanguages were selected as representative of some widely spoken language families, and because these were the native languages of 4 in-house bilingual employees. cone reviewer per translated language. dusing standardized assessments, reviewers judged the impact of each category on the meaning, understanding, and readability of translated text. e“accuracy” and “likelihood of misinterpretation” were assessed using a 5-point likert scale; 5 = highest accuracy and lowest likelihood of misinterpretation. 5 ipsen-sponsored publicationsa,11–15 with abstracts and plss of similar length covering a range of therapy areas and study types 4 languages translatedb a french german slovenian mandarin 4 bilingual reviewersb word selection grammar phraseology claritye non-translated additions deletions using google translate with medical writing experience evaluated 4 survey categories assessedd 20 translations per document typec 5× plss 5× abstracts misspellings phrases tone grammar/syntax punctuation symbols/units/numbers/dates accuracy likelihood of misinterpretation 诶 http://www.amwajournal.org amwajournal.org 16science without borders – can translation tools bridge the language gap? original documents on the translations. all of the selected publications had utilized medical writing assistance, ensuring that they were written in high-quality english. google translate was used to translate the plss and abstracts into 4 languages that are representative of some widely-spoken language families (french, german, mandarin, and slovenian). although other browser-based translation tools are available, we selected google translate because it is well known, free to use, and is incorporated in google chrome, the most widely-used internet browser (as of july 2023).16 for each language, 1 bilingual reviewer with a scientific background assessed the translation quality using predefined survey questions that covered the appropriateness of word/phrase selection, grammar, and clarity. reviewers assessed the number of errors of each type, and used a 5-point likert scale17 to measure the impact of these errors on the meaning of the text. results word selection when assessed at the level of individual words, translations of plss and abstracts performed similarly (figure 2). inappropriate word insertion (0.2% vs 0.1% words), omission (0.2% vs 0.2%), and misspelling (0.05% vs 0.02%) rates were low in both translated plss and abstracts respectively, and most errors had little or no impact on the meaning of the text. however, translated plss had lower proportions of untranslated and mistranslated words than abstracts (both comparisons 0.6% vs 1.0%). phraseology there were fewer incorrect phrase translations in translated plss than in translated abstracts (0.35 vs 0.41 errors/100 words). grammar translated plss had similar rates of grammatical/syntax errors to abstracts, but a lower proportion of these errors was identified as having the potential to lead to misinterpretation (17.2% vs 40%, respectively). clarity on a 5-point likert scale, translated pls scored favorably compared with abstracts for overall translation accuracy (mean, 4.60 vs 4.30, respectively) and likelihood of misinterpretation (mean, 4.55 vs 4.25, respectively). for overall translation accuracy, the proportions of translations considered to be “very accurate” were 60% for plss and 45% for abstracts (figure 3). regarding how likely it was that translation errors would lead to misinterpretation of the information, 60% of translated plss and 45% of translated abstracts were scored as “definitely not” likely to be misinterpreted (figure 4). there were no notable differences in results between different languages, although the sample size was not large enough to detect inter-language differences. discussion the language barrier is a big hurdle for information accessibility in scientific publishing. one solution could be for english-language journals to provide alternative languages for abstracts. nevertheless, there are many difficulties with this approach, not least the cost, workforce capacity, and expertise needed to review translations. figure 2. translation errors (a. word selection and b. phraseology). pls, plain language summary. missing inserted untranslated misspelled incorrectly translated incorrectly translated 0.22 0.20 1.05 0.64 0.020.05 1.2 1.0 0.8 0.6 0.4 0.2 0.0 w or d t ra ns lat ion er ro rs (% ) 1.2 1.0 0.8 0.6 0.4 0.2 0.0ph ra se tr an sla tio n e rro rs (e rro rs pe r 1 00 w or ds )a b plss abstracts 0.17 0.07 0.55 0.98 0.35 0.41 figure 3. translation accuracy. none of the reviewers found the translated text of plss or abstracts in any language to be “inaccurate” or “very inaccurate.” pls, plain language summary. 60% 40% 45% 40% 15% very accurate accurate acceptable inaccurate very inaccurate overall, how accurate was the translation to the original text? plss abstracts http://www.amwajournal.org amwajournal.org 17science without borders – can translation tools bridge the language gap? if freely available tools can translate scientific information clearly and accurately, non-english speakers could use these tools to read scientific abstracts in their own language. our pilot study showed that, although not perfectly, both plain language and technical language scientific information were considered accurate and readable when translated using google translate. plss scored higher across most measures, possibly owing to the inclusion of complex sentences, abbreviations, and scientific terminology within the abstracts. however, the differences were generally small, and no statistical testing was conducted to establish whether the differences were statistically significant. based on comments provided by the bilingual reviewers in our study, there are potential considerations when writing plss and abstracts that may help to make the text more easily understood when translated via browser-based software. translations of text that used the active voice were more readable and natural than those that used the passive voice. acronyms were not translated consistently; although google translate could often recognize an acronym when it was first defined, acronyms were often lost in translation when used subsequently, or when an “s” was added to create the plural form. practical guidance has previously been given for creating plss that are accessible for laypersons,18,19 and a similar set of recommendations for creating translation-friendly summaries would go some way to helping non-english speakers have easier access to scientific information. learnings from this study inform some initial recommendations, but more work will be needed to refine this list in the future. although this study focused on abstracts and plss, it highlights the importance of using clear and simple language in general. ideally these learnings should also be applied to full-length articles. in 2020, future science group was the first publisher to offer full-length plss of publications (plsps)—standalone summaries of entire articles written in nontechnical language.19 several of these summaries have been made available in several languages,20-23 despite the original scientific article being published in english language only. additional publishers have now also started to offer similar opportunities to publish in plain language. however, fewer than 100 plsps have been published to-date, so they do not yet offer a broad opportunity to make full-length plain-language texts available for translation by non-english speakers.24 these study results are promising, but are small adjustments to the way we write enough to enhance access to medical information for non-english speakers? some journals already offer translated abstracts, and multilingual journals publish abstracts in multiple languages. other journals allow the opportunity to upload a translated abstract in the author’s native language or in additional languages. despite this, even when a translation is available, it is not always easy to find. without knowing in advance which journals offer abstracts in their native language, non-english speakers must search for them, so how can we ensure non-english speakers can find the articles they need? language filters are available on pubmed for articles written in non-english language, but for englishlanguage publications, pubmed displays abstracts in english by default. when a translation is available, this must be accessed via a link.25 there are tools available to help non-english speakers to use pubmed to find articles written in their native language. technical solutions have been proposed to allow non-native english speakers to search for english-language articles on pubmed, for example, a webbased tool that helps users to build pubmed searches in several languages (multilingual query builder).26 however, to the best of our knowledge, these search tools are neither readily available nor in common use. whether they speak english or not, laypersons wishing to access scientific literature may not be experts in searching for scientific information. there may be additional need to ensure that plss are easily found. although some plss are indexed and tagged in pubmed, there may be a need for a lay-friendly database or search engine dedicated to plss that would ideally be searchable in any language. additionally, publishers and the scientific community figure 4. likelihood of misinterpretation of translated text. none of the reviewers found the translated text of plss or abstracts in any language to be “probably” or “definitely” misinterpreted. pls, plain language summary. 60% 40% 45% 40% 15% definitely not plss probably not possibly probably definitely overall, how likely is it that the text will be misinterpreted? abstracts http://www.amwajournal.org amwajournal.org 18science without borders – can translation tools bridge the language gap? should work together with providers of translation software to ensure that, when professional translations of technical language publications have been provided, these are made available for training of machine translation software. it is likely to be some time, if ever, before google translate (and similar software) is sufficient for people to remove the need for specialist translation of scientific articles. this is particularly pertinent to the pharmaceutical industry, in which companies must comply with professional standards, regulations, and laws to ensure clinical trial results are reported accurately. currently, translations from browser-based software could not be used without professional review of the translation. study limitations with only 5 publications, 4 languages, and 1 reviewer per language, the sample size in this study was limited. although efforts were made to include different therapy areas and study types, the publications were developed by a single sponsor and were of uniform quality, and the writing style was similar across the 5 publications. for the most part, there is a lot of internet content written in the languages we used in the pilot study, and google translate is likely to have been trained extensively in french, german, and mandarin. browser-based translation tools may not perform as well with languages that have a smaller internet presence. although multiple alternative tools are available for automatic translation (deepl, microsoft translate, and chatgpt), google translate was the only software used in this study. although all these popular translation tools employ machine learning techniques (a subset of ai),27-29 there is currently a lot of public interest in chatgpt and future advancements in similar large language models. recent studies suggest that the current iteration of chatgpt does not yet consistently outperform google translate or microsoft translator, and performs worse with less widely spoken languages.30 although there is a lot of excitement about the future of chatgpt in many fields, it is still reliant on the availability of training data. the results of this study may not easily be extrapolated to other publication types because we included only short text-based summaries. these were easy to handle using google translate, but this approach may be less practical for longer texts or articles in which a lot of the information is embedded in figures and tables. although google translate does have capabilities for translating whole documents, the complexity of the document formatting can affect how successful this is. finally, a survey-based approach was used to assess translation quality. the quality assessment could be expanded to also include the reverse translation method, in which google-translated abstracts and plss are translated back to english by a translator who has no knowledge of the original text, with the results compared with the original to check for equivalence of the wording. although there has been recent focus on making scientific information more widely available, there remains a gap for non-english speakers. ideally, professional translations would be available for all english-language scientific research, but this is not a practical solution. it is possible that, with technological advances, it will get easier for non-english speakers to search for, find, translate, and understand literature originally published in english. in the meantime, we propose that the publishing community should increase its commitment to plss, including improving their discoverability (eg, ensuring correct indexing on pubmed). wider availability and accessibility of these lay-friendly summaries should not only provide an accessibility benefit to english-speaking readers but should also improve access for non-english speakers by enhancing the accuracy of translations using browser-based tools. acknowledgements we thank nicolas bertheleme, claudia brockmeyer, shufei song, and maša švent who were the language reviewers involved in the study. development of this article was jointly funded by ipsen and oxford pharmagenesis ltd. author declarations and disclosures: all authors made substantial contributions to study conception/design, or acquisition/ analysis/interpretation of data; drafted the publication or revised it critically for important intellectual content; and gave their final approval of the publication. claire beeby is an employee of oxford pharmagenesis ltd; eleanor j. raynsford and charles pollitt are employees of ipsen. oxford pharmagenesis ltd is a healthscience consultancy contracted to support ipsen with medical communication and medical writing activities. author contact: claire.beeby@pharmagenesis.com references 1. edgell c, rosenberg a. putting plain language summaries into perspective. curr med res opin. 2022;38(6):871-874. doi:10.1080/ 03007995.2022.2058812 2. frank j, foster r, pagliari c. open access publishing noble intention, flawed reality. soc sci med. 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https://ai.googleblog.com/2016/09/a-neural-network-for-machine.html https://ai.googleblog.com/2016/09/a-neural-network-for-machine.html https://arxiv.org/abs/2303.13780 http://www.yseop.com v38 n4 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 20 abstract a high-performing medical writing team begins and ends with talented writers, editors, and leaders who understand their mission and their business. a panel of writers comprising the authors convened virtually on october 28, 2021, at the american medical writers association national conference to discuss this topic. the topics of value proposition and business models; communication, leadership, and corporate responsibility; and financial acumen will be reprised in this 3-part series. the series will also include thoughts from the authors looking to the future of the business of medical writing, including what we can do in the medical writing community to introduce these concepts earlier in the medical writing career path. this part 2 manuscript focuses on communication, leadership, and corporate responsibility. a high-performing medical writing team begins and ends with talented writers, editors, and leaders who understand their mission and their business: the value proposition, the finances that drive strategy and decision-making, the financial goals, and effective communication. a panel of writers comprising the authors convened virtually on october 28, 2021, at the american medical writers association (amwa) national conference to discuss this theme.1 the topics of value proposition and business models,2 communication, leadership, and corporate responsibility, and financial acumen will be reprised in this 3-part series, along with thoughts from the authors looking to the future of the business of medical writing, including what we can do in the medical writing community to introduce these topics earlier in the medical writing career path. this part 2 manuscript focuses on communication, leadership, and corporate responsibility. the authors’ collective experience comprises the following medical writing work environments: • freelance business • small business/vendor • department leadership of smallto mid-size biotech company and large-sized pharmaceutical company the moderator’s (joan affleck ja) prompt is provided for each topic, followed by each perspective on the topic. in some cases, text from the session has been paraphrased for optimal clarity in this medium. communication in a business context ja: there’s so much to being a business leader. we’ve talked about value proposition, business models, finances;2 another area i want to touch on is communication. now— communication: this is our stock-in-trade, right? we should get this part. but i’m willing to bet you have all discovered that communication is a little bit different in the business context, and i wonder what kinds of communication situations you’ve run into and how you’ve used communication to help your business succeed. maybe you’ve had to speak differently with potential or actual customers, employees, and collaborators, maybe even a detractor. so, how do you see communication as being an essential element of business leadership or business acumen? dd: it will make or break you, regardless of where you sit. that’s the bedrock of what we do, and people ask you all the time as a medical writer—“so, what is it that you do?” if you can explain that to them clearly and communicate what you’re doing, that’s half the battle because you’ve explained what the baseline is in terms of this conversation you’re having. within teams it’s the same requirement: you need to explain to the team what it is you bring to the table, why you’re doing it, and what they need to know. the important thing for me and for my teams is to answer the questions before my teams ask them of the writer or the writing team—to anticipate things, to have a contingency plan in place, and to be able to communicate that to put the client (and that is the team, in my case) at ease with the sense that the writer and the writing team have been here before and can see what’s coming before i can see it. if we can do that, the business of medical writing: communication, leadership, and corporate responsibility joan affleck, mba1; dominic de bellis, phd1; brian bass, mwc2; and jeanette m. towles, ma, rac-drugs3/ 1merck & co, inc, rahway, nj; 2bass global, inc, fort myers, fl; 3synterex, inc, dedham, ma topical feature part 2 in a 3-part series http://www.amwajournal.org amwajournal.org 21the business of medical writing: communication, leadership, and corporate responsibility it takes away a lot of the tension within the team that really doesn’t need to be there. and it comes with experience, i agree, but you can communicate to the team, “this is the first time doing this kind of project; we need to learn a few things from you, but i’d like to help you with what we bring. we know how to write the document, but we have to work together.” and that’s ok, too, but as long as that’s explained up front, people understand where everybody’s coming from. again, it’s this same transparency of communication that carries the weight of the work forward in a good way. ja: that “taking away the pain” that jeanette talked about earlier.2 dd: right, as much as possible. the writers are the document development experts, and they know many things about the regulations and all the trappings around what has to take place with the document. the team members have to focus on their expertise, or the client has to focus on whatever this product is that you’re contributing to; we have to help them not worry about our piece of it to the degree we can, and that’s important. ja: as some of you have mentioned earlier—everyone learns to write; therefore, they think they are the writer, so we may need to get them to stay in their swim lane! jt: i think communication is so important, too, in just being able to explain to your clients what you think the gains are going to be. the best example of this i had was when i was working in-house in a department and was in a meeting with a senior regulatory person and the president of the company, who was a typical mba—very focused on the return on investment and [having] very bold goals for her company. they were talking about narratives and how those are done, and i made the mistake of saying, “this is the industry-standard way of doing this,” and i found out later that this was a phrase that tended to make her head explode! but it took that other senior leader in regulatory leading me down the path in this meeting to say, “ok, well, i understand that, but which parts of this process can we break down—which parts do we need to stay married to, to maintain the quality, and which parts can we potentially try to be a little more bold about?” i immediately saw where she was going with it, too;…i understood that what i had said was maybe not the right thing to say. having someone who you can observe and who can model that behavior to help you translate what you are trying to say from a medical writing standpoint into something that makes sense to someone who is interested in that return on investment is critical. again, that’s where that mentoring comes back in; and it doesn’t even have to be someone within a medical writing group, it could be a senior leader in regulatory or some other adjacent function who can help navigate and model some behaviors. bb: from a freelancer’s standpoint, i think there are 3 key communication areas that freelancers need to pay most attention to, and if they do, it will really help with their success (and by that, i mean delivering their value to their clients) (figure 1). the first is responsiveness. the only thing worse than when a client reaches out to you with a new project and they don’t hear from you, is when you are in the middle of a project and the client reaches out to you and gets crickets. nothing will instill apprehension faster than that. we’re all busy and know how hard that is, but one of the things i’ve worked very hard at is responding almost immediately to clients, even if it’s just to say, “hey, i got your message; i’m in the middle of something, and i’ll get back to you later”—just so they know i’m here and on top of things. the second thing is confidence when i’m speaking with clients—trying to speak the language of the project and the work that needs to be done so my client knows that i get it, that i understand what we are all talking about. this gives them the confidence to move past “can they do the job?” and get into “let’s get them the information they need to get the job done.” the third thing is frankness. where the other 2 things are probably mostly of benefit to the client, this third thing is really of benefit to the freelancer. people who are on staff don’t think about certain business aspects the way freelancers do, and i find myself having to explain in very lay terms why things work differently for freelancers than they do for staff people. as a quick example, i estimate projects and invoice on a project basis rather than an hourly basis. a lot of clients don’t get this. i find it helps clients to understand me better when i explain to them that if a project is ultimately, let’s say, $1,000 for the sake of argument, does it really matter if it takes me 10 hours or 2 hours to get to the end result, or 20 hours? it shouldn’t, because the bottom line is, can it get done within the budget, and is it done properly? the better we get at what we do, [we] also get faster at it. because there is a limit to what anyone will pay on an hourly basis for someone, it forces us to work more the better we get in order to earn the same money we made when we were less experienced. when i lay it out in those terms to clients, http://www.amwajournal.org amwajournal.org 22the business of medical writing: communication, leadership, and corporate responsibility you can see a little lightbulb go on that they understand the dynamics involved, and i find that helps build the relationship. ja: is that the same for you, jeanette, in your business? jt: slightly different. i think historically—and i totally agree with everything brian just said to a large extent—we do tend to go in the time and materials direction for the main reason that when you have an expanded network, you would really have to have a lot of capital behind you to be able to absorb the type of risk you would need to. say the project gets delayed and you can’t bill for a unit until 3 months from now—well, you still have to pay your people. it really depends on the individual circumstances and what type of business model makes sense. but [as] we’ve also been considering lately, does that make sense for some of our clients but not all of them? i think you have to have the acumen to know when to reexamine your model, and it should be done frequently to make sure that it still makes sense and is optimizing the amount of time you put into what the dollar amount actually ends up being in the business. a kind of dual approach is needed there—and the ability to be self-reflective about it. ja: and look at that: you’ve brought in the finance with communication and business model all in one example, and you added in that really interesting factor of being able to assess risk in business. fascinating! we have described this panel discussion in the brochure for the conference as being for midcareer writers. but afterward, i realized we don’t really know when we should be talking about and teaching writers business skills. what are your thoughts about that: is midcareer the right time, or do you have a different idea? bb: i vote for teaching it from the very beginning. dd: day 1—agreed. bb: when we’re learning how to write, we should be learning economics and finance—and teaching it. jt: i completely agree. from the freelancer perspective, one of the things i’ve intentionally done recently is talking about the sales funnel in our operations group (figure 2). again, for us, that’s people coming in earlier in their career and learning the operational aspects; they may or may not aspire to be medical writers, [but] they need to understand where those touch points are with the clients, and why those things are important to that concept of operational excellence, which is our pitch. because if they don’t, we’re not able to achieve that operational excellence. they also need to understand what keeps the client coming back in the sales funnel, which is the ultimate goal; you don’t want to court a client once and then have them leave you—that wouldn’t be time well invested. so, helping people who are coming into the department understand where they fit into it—not only once but continually—is a return on investment for [my taking] the time to talk about that. figure 1. three key areas for communication for medical writers. figure 2. the sales funnel. adapted from: crail c, bottorff c. sales funnel template and examples for 2023. forbes advisor, july 3, 2023.3 http://www.amwajournal.org amwajournal.org 23the business of medical writing: communication, leadership, and corporate responsibility dd: in particular—more so for the freelancer than for the in-house employee—each of us has to know what our value is in terms of what we bring to the client. and if we don’t know how much we can bill, or how much we are worth, or what it is we think we can demand for what it is we are asked to do, then the whole idea of business dissolves. if you’re providing something and expecting to be paid for it, by definition you’re in business, like it or not; and you have to understand that if you’re offering someone a product and expecting them to give you money, then all of the trappings of that understanding have to go hand-in-hand—you can’t have the work product and the money be separate and not think about or not understand [the relationship of] one to the other. ja: i think that, too, even in a corporate situation in which you might feel a little bit more removed, there’s benefit in owning your project more, owning those cycle times, owning the quality rating of your project—to take pride in that and work toward higher standards. bb: freelancers need to understand where they are in the food chain. it really comes back to this value proposition2; in order for everyone to be able to make money and justify costs, there has to be that “wow factor” at the end that makes everyone say, “that was really a great experience— let’s do that again.” ja: love it! [because] none of us benefited from a formal program to teach us about the business aspects of medical writing, let’s do a little futuristic thinking, a little pie in the sky: if you could help design a program, what would that include? what are some examples of the best ways for writers and editors and leaders in medical writing and medical communication to actually acquire business literacy—what do you think we need to put in place? bb: from a financial standpoint, i would recommend courses in bookkeeping, estimating, budgeting.... whether you are a freelancer or someone who is ultimately going to run a department, you need to know all those things. dd: you have to be an expert project manager. you have to understand time and materials and how much you can accomplish in a unit of time. [that emphasizes] the importance of the right metrics calculated and maintained routinely [to] give you data from which you can better cost your projects. to brian’s point on the project basis, if he didn’t know what he could do in a unit of time, he would never be able to come up with a project estimate that was of any value; you have to understand what you can do. we have to teach the writer to understand themselves at the beginning, [to] know what they can do and say, “ok, i can write 1,000 words in 2 hours,” and that means i can write a manuscript every 3 days [or whatever that happens to be], and therefore i can do 2 manuscripts per week. [only] then you can begin to see how all these pieces add up, and that’s the important part—to make the connection between the academic work we know as writing and the numeric concepts we associate with business. but the 2 things have to go together; they can’t be separate. jt: one component i might add to that—and this might surprise you—[is] emotional intelligence. one of the hinging points of my career was [when] someone handed me [daniel goleman’s] book emotional intelligence,4 and we read it as a group in the department. again, this was in the context of a regulatory department, so there were lots of benefits in terms of being able to use that material if you were presenting to the [us food and drug administration], but you could also use it to leverage conversations with your colleagues in other departments and bring them to a point of alignment on certain issues.... studies have actually shown that [although] for certain skills you can’t teach an old dog new tricks, emotional intelligence is not one of them; it’s one you can continue working on no matter how advanced you are in your career. so, [this applies] not only for those just coming in, but also continually throughout your career, as well as in leadership [positions]. leadership ja: another thing that i think you all have touched on at one point or another is this idea of mentoring and observing and having access to leaders that you can just observe and learn what tricks they have up their sleeves to make the business work. do any of you have an example from your own experience of how your understanding of business has helped you lead a team through a period of significant change? we all know change is the only constant, and i’m just wondering how it has served you. bb: for me, an area that’s a good example is negotiating. part of my goal—and maybe that’s why my particular freelance model seems to work pretty well for me—is for all the freelancers on my team to make as much money as possible and make the client say, “wow, that was fantastic—let’s do that again!” therein lies the value for all of us. but we all come to the table with various skills, and some of them are strong, and some of them are not. one of the areas i find myself working with the freelancers on my team on is when the client pushes back on an estimate. the one thing i think i’ve taught to everyone on my team is to be really open and http://www.amwajournal.org amwajournal.org 24the business of medical writing: communication, leadership, and corporate responsibility honest in our conversations with the client about where they think things went off, so we can go back and look at the way we prepared the estimate to see where we may have gone wrong. as much experience as we all have, we’re not always perfect, and to have the opportunity to have clients feel open enough that they can come back and discuss money with you, which is something no one is comfortable talking about, is really great for me. because 9.5 out of 10 times, we end up coming to an agreement that works for everyone. jt: obviously, one challenge that everyone had is covid. within our business, when it first began, we saw a lot of early-phase stuff fall off the map if it wasn’t in a critical area, so one thing that i think really preserved our business model at that point was the fact that we had diversified the types of things we work on. so, we work on a little bit of latephase stuff, a little early-phase stuff, a little in rare disease, a little in oncology; and so, because we took that approach intentionally and are looking all the time at how healthy our clients are—what are they bringing in in terms of overall income, and do we need to pursue any new business— we were able to quickly balance our portfolio once certain things started falling off at that point. dd: i guess things are a little bit different in-house, but from a negotiation standpoint and an emotional intelligence standpoint, [there is] absolutely the same obligation on the part of the writer to really know how to speak with the team, anticipate things, and really instill trust and confidence. covid changed our work environment, as it did for almost everyone, and we all ended up working remotely, which is different than the in-house team members were accustomed to by and large. as a manager, you have to be resilient and [amplify] that resiliency to your staff and get them to remain motivated in the right ways; and oftentimes that comes down to a lot of interpersonal interactions— even more so from a 1:1 perspective than you may do otherwise in normal business because we were all under these unusual pressures we had never faced before. making an open acknowledgment that we are all in this new world together was important for everyone to understand and say, “look, whatever this is, we’ll get through it one way or another, but we have to keep our eye on the work and give us some focus and a sense of purpose at the same time.” i think that really carried a lot of people forward in the right way…. at the end of the day, we are still people. corporate responsibility ja: i want to pull a little bit on this thread of corporate responsibility.2 how does that fit into your role as business leaders? for example, dom, i know that where you work, the company has a big investment in corporate responsibility, to the point where they give drugs away for free sometimes. do you see that play out in your department? dd: yes, because at least from the leadership standpoint, many of my colleagues are committed to medical writing, and they understand what the field is about. and that’s really a unique component, in that having that breadth of knowledge about what medical writing is and what it takes to do it allows us to focus on the people in our teams and try as we can to develop them to their fullest potential. we have a responsibility to the people on the one hand, but the responsibility to society at large comes through at the end of the day when we bring the products through and market those drugs based on the filings we support. so, looking at all of these integrated pieces really allows us to contribute to that, and being at merck has allowed us to be part of that. ja: others—comments on that piece about corporate responsibility? jt: i always like to say profit and progress are not mutually exclusive. so, in continuing our business, making sure it is profitable, and doing all of the things a responsible business owner can do, i think there are opportunities for the team to get involved in things they care about. as an example, this summer we ran an internship for the first time, [which both] afforded us the potential to expand the available resource pool to medical writing in general [and offered] something that wasn’t really out there for this particular group of individuals. it was really a pilot for us, so we... are going to keep working on that [using our first intern’s feedback]; everyone who was involved with that process was really energized by it, too, and that’s something that is easy to forget sometimes. but it’s something we really play close to the heart here because we have a particular viewpoint as a disability-owned business in terms of some of the challenges we have faced over time in industry, and we want to use that experience to make the pathways positive for anyone who does want to enter the field from any walk of life. ja: music to my ears! we have an internship program and an apprenticeship program in my department. http://www.amwajournal.org amwajournal.org 25the business of medical writing: communication, leadership, and corporate responsibility bb: my company is not large enough to have an internship program, so i do a lot of mentoring. it’s important to me to do that as a way of giving back to the industry i’m in and giving back to the world that i work in and live in, to help bring people up to that level of experience and expertise that make them someone i could bring onto my team. but unlike my colleague’s groups in which you have a certain amount of work to do and need to bring people in to do it, my company doesn’t have to grow to bring in people to do work; i’d rather not take work that we’re not qualified and do not have the best people to do, so i’m in a position to be able to flex that in the opposite direction. ja: i think we do a little bit of both, right dom? dd: at times, yes. we try to provide balance for our people, and we try to move the work around in a way that’s manageable for all involved. it doesn’t always work out the way we’d like it to, but again, nothing is perfect. ja: in terms of taking on new work, though, we are similar in philosophy, brian, in that we don’t just take on work for the sake of taking on work. we take on work for which we feel we are qualified and to which we feel we will really bring added value. bb: that really is the bottom line. the worst circumstance anyone could find themselves in professionally is to realize down the line they should have said no. jt: yeah, absolutely, and i would say the converse is also true. some of the best experiences i’ve had professionally have been when i was afraid to say yes. i was offered a promotion, and i had a 9-month-old. well, that was a tough one, but i said yes, and i was better in the long run for it as hard as it was. but weighing those options is important no matter what you decide. bb: and that is how we stretch ourselves—you’re exactly right, jeanette. if we don’t say yes to things that we’re not positive we can do, then we never learn how to do them. we never prove to ourselves we can do them. i guess it’s being sensitive to where that magical line is. dd: but knowing who to ask if you have questions along the way also helps, right brian? bb: oh yes, indeed, dom—absolutely. yes—someone you can turn to, to get that leg up when you need it. looking toward the future in part 1 of this 3-part series, the authors discussed how this panel was an initial dialogue meant to “kick off a broader discussion of the many aspects of business leadership as it applies to our work as medical communicators.”1 the authors concluded that having a comprehensive business curriculum, namely a pathway whereby medical writers can readily learn the skills needed to demonstrate leadership while also participating in decision-making activities earlier in their careers, would benefit the writer toward the goal of developing a strategic mindset while learning fundamental business topics.2 one of the key functions of leaders is to execute on a business’s strategic plan, which outlines corporate goals that are intended to “trickle down” to departments and individuals.5 well-stated goals might even ensure the goal is in a specific, measurable, achievable, relevant, and time-based (smart) format—but, typically, a strategic plan only tells you what the goal is (eg, file new drug application [nda] for drug xyz in q1 of 2023”) and occasionally the metric it will be measured by (eg, authorization of xyz in the us by start of q2 2023). the plans most often do not cover the how or the why of arriving at that particular outcome. if you are a leader focusing intensely on doing your best to meet the company’s goals, you could still be missing a very important part of the equation. here is an example: as a leader, you looked at the above corporate goal for filing the drug xyz nda, and you did your diligence and determined you need to hire a new vendor to be able to complete the work. you did not realize that procurement has been given a directive to increase diversity and inclusion by trying to onboard small and diverse vendors, so your vendor selection and qualification process became delayed and could now comprise a risk to the submission deadline. this background discussion was not part of the corporate goal but became critical toward understanding how the company wanted the goal met and wanted business to be done to optimize corporate responsibility. after all, learning to communicate about business— and, most importantly, how to listen to what is important to business leaders—is currently not a distinct component of medical writing education.6-8 as previously discussed,2 the amwa recommended training outline for regulatory writers6 acknowledges that the skills in the outline are only some of the skills and proficiencies needed for professional success but does not distinguish business knowledge as a separate training topic, although it does note that “soft skills are crucial for working efficiently, gaining trust, communicating and collaborating effectively with colleagues, and achieving personal and company goals.” the outline also http://www.amwajournal.org amwajournal.org 26the business of medical writing: communication, leadership, and corporate responsibility highlights leading without authority, influencing and persuading, and negotiation, which are some of the skills medical writing leaders need to acquire, but applying these skills in the day-to-day with teams on documents and applying them to a management audience are different endeavors. exactly how these skills can be acquired and understood as early as possible in medical writers’ careers remains our fundamental challenge. at the end of the day, whether we are the ceo of a medical writing group within a corporation, of our own corporation, or of our own freelance business, we all work for a company, and a company must have a way of doing, or an ethos, that guides its daily work. it is the responsibility of leadership to build a bridge and ensure not only that a company’s goals are met but also that its ethos is incorporated into everyday work in an authentic way to make certain that the outcomes will be positive and sustained over the long term. this means that medical writers in leadership (or pondering leading) should strive to understand the importance of corporate responsibility and actively seek to connect their personal ethos with that of the company, as well as to communicate that outward to their medical writing teams and customers. author declaration and disclosures: j. affleck and d. de bellis are employed by merck & co, inc, and are shareholders. b. bass and j. towles note no commercial associations that may pose a conflict of interest in relation to this article. author contact: jtowles@synterex.com references 1. american medical writers association. national conference brochure. amwa; 2021. accessed july 3, 2022. https:// cdn.ymaws.com/www.amwa.org/resource/resmgr/ conference/2021/2021amwa_conf_program_june15.pdf 2. affleck j, de bellis d, bass b, towles j. the business of medical writing: understanding the value proposition and successful business models [part 1 in a 3-part series]. amwa j. 2023;38(2): 21-25. 3. crail c, bottorff c. sales funnel template and examples for 2023. forbes advisor. updated july 19, 2023. accessed july 3, 2023. https://www.forbes.com/advisor/business/sales-funneltemplate/ 4. goleman d. emotional intelligence. bantam books; 2005. 5. towles j. creating a strategic plan for a medical writing department. amwa. april 14, 2021. http://amwa. mycrowdwisdom.com/diweb/catalog/item/id/6497462 6. yih l, alexander ll. recommended training outline for regulatory writers. american medical writers association (amwa); 2020. accessed march 3, 2023. https://info.amwa.org/ hubfs/offers/regulatory-writer-training%20ebook/regulatorywriter-training.pdf 7. clemow db, wagner b, marshallsay c, et al. medical writing competency model section 1: functions, tasks, and activities. ther innov regul sci. 2018;52(1):70-77. doi:10.1177/2168479017721585 8. clemow db, wagner b, marshallsay c, et al. medical writing competency model section 2: knowledge, skills, abilities, and behaviors. ther innov regul sci. 2018;52(1):78-88. doi:10.1177/2168479017723680 amwa live webinars tools, tips, and tricks for medical communicators. www.amwa.org/events only $20 for members can’t attend a live webinar? you won’t miss out! all registrations for live webinars include access to the recorded video in amwa online learning. http://www.amwajournal.org https://cdn.ymaws.com/www.amwa.org/resource/resmgr/ https://cdn.ymaws.com/www.amwa.org/resource/resmgr/ https://www.forbes.com/advisor/business/sales-funnel-template/ https://www.forbes.com/advisor/business/sales-funnel-template/ http://amwa.mycrowdwisdom.com/diweb/catalog/item/id/6497462 http://amwa.mycrowdwisdom.com/diweb/catalog/item/id/6497462 https://info.amwa.org/hubfs/offers/regulatory-writer-training%20ebook/regulatory-writer-training.pdf https://info.amwa.org/hubfs/offers/regulatory-writer-training%20ebook/regulatory-writer-training.pdf https://info.amwa.org/hubfs/offers/regulatory-writer-training%20ebook/regulatory-writer-training.pdf v38 n1 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 7 the john p. mcgovern award is named in honor of john p. mcgovern and is presented to a member or nonmember of amwa to recognize a preeminent contribution to any of the various modes of medical communication. the mcgovern award is presented during amwa’s medical writing & communication conference. thank you very much for the honor from amwa and the opportunity to be able to speak with you. this means a lot to me, not only as a science communicator, but also because i’ve been writing books about the geopolitics of vaccines and global infectious diseases. having this kind of recognition, for me, is particularly special. i’m sorry i can’t be there with you in denver, but please understand how important this honor is for me and my association with amwa. my career as an md/phd vaccine scientist is an interesting one and has kind of a dual aspect to it. for the last almost 40 years now, since i started as an md/phd student in new york in the 1980s, i’ve been working to develop vaccines for poverty-related neglected tropical diseases as well as viral infections. i’ll talk about our work to develop a new covid vaccine now in use in india, indonesia, and elsewhere. the other side is because i have four adult kids, including rachel—who has autism and intellectual disabilities—and wrote a book a few years back called vaccines did not cause rachel’s autism because that was kind of the phony assertion from antivaccine groups. going up against them, by default, i became an expert not only in the vaccine science but the antiscience. i’ve been writing and speaking about that. today, what i want to do is speak to you about both aspects: the positive side and fight for developing vaccines for poverty-related diseases as well as coronaviruses, but, at the same time, increasingly i’m being called out to combat widespread antiscience activism and antiscience aggression. to start out on the positive side, i’m a professor at baylor college of medicine, where i’m also the dean of our school of tropical medicine. together with my science copartner for the last 20 years, we cohead the very interesting center for vaccine development that has been making vaccines for parasitic infections in africa, asia, and latin american countries, such as schistosomiasis, hookworm, chagas disease, and leishmaniasis. then, about 10 years ago, we started developing coronavirus vaccines for sars and mers and, ultimately, covid-19. the center for vaccine development is based at texas children’s hospital (coheaded by myself and my science partner for the last 20+ years, dr maria elena bottazzi), part of our enormous texas medical center, which is the world’s largest medical center. we sometimes call our vaccines for parasitic diseases antipoverty vaccines because they’re vaccines for disease that not only affect health but also trap people in poverty through their effects on child development, work or productivity, and pregnancy outcome. the vaccines also are a potent antipoverty tool, so we call them antipoverty vaccines. i first wrote about them in my first book, which is called forgotten people, forgotten diseases. one of the things that we do at our center for vaccine development—it’s not a typical academic center and is actupeter j. hotez, md, phd1,2,3,4 / 1texas children’s hospital center for vaccine development, national school of tropical medicine, baylor college of medicine, houston, tx; 2department of biology, baylor university, waco, tx; 3james a. baker, iii, institute of public policy, rice university, houston, tx; 4scowcroft institute of international relations and hagler institute for advanced study, texas a&m university, college station, tx 2022 john p. mcgovern award address global vaccines and vaccinations: science vs. antiscience conference http://www.amwajournal.org amwajournal.org 8global vaccines and vaccinations: science vs. antiscience ally developing the vaccines—is we use technologies, whenever possible, that are compatible with those used by vaccine producers in lowand middle-income countries (lmics) that have banded together to call themselves the developing countries vaccine manufacturers network (dcvmn). there are about 40 of these institutions in asia, africa, and latin america. one of the common technologies that is widely used is microbial fermentation in yeast to make recombinant protein vaccines, which is the technology used to make the recombinant hepatitis b vaccine. for instance, countries like bangladesh, china, india, indonesia, etc., all make their own recombinant protein hepatitis b vaccine. if you want to plug and play into the system so that vaccines could be made locally in lmics, this is a pretty good technology to use. another aspect is that it’s a vegan technology—no animal cells, human cells, animal proteins, or human proteins—so it has the capacity, for instance, to be made as a halal vaccine for muslim-majority countries, which is also extremely helpful at times. our parasitic disease vaccines include vaccines for human hookworm infection and schistosomiasis, which is in phase 2 clinical trials. there’s a lot of interesting science behind it that i won’t go into, but we’re trying to develop and distribute vaccines on the african continent, southeast asia, and latin america. the point is if you were the ceo of a biotech, this would probably not be the map you want to have in your business plan because most of the pharma industry and biotechs are focused on the global north, meaning north america, western europe, and japan. so, the science that we’re doing is interesting, but we’re also trying to identify sustainable financial models for them to recognize that the return on investment is going to be very modest compared with vaccines intended for north america or europe or japan. our vaccine for schistosomiasis, which is in phase 2, is also helping a major problem of women’s reproductive health, that is, female genital schistosomiasis, which affects 40 million girls and women on the african continent. our chagas disease program targets a parasitic infection in the latin american region that affects about 6 to 7 million people living with chagas disease, of whom about 20% to 30% can go on to develop heart disease, chagasic cardiomyopathy, which is caused by the parasite depositing, inducing the formation of collagen and fibrotic deposition as well as inflammation. this happens even despite antiparasitic chemotherapy. dr kathryn jones, who heads our chagas disease pathogenesis program, has been working with our vaccine center to develop a new prototype chagas vaccine that will go into phase 1 clinical trials in mexico next year. this gives you an example of the type of parasitic disease targets that we’re interested in. of course, the problem with covid-19 vaccinations was that the mrna vaccines developed by pfizer and moderna were not readily available for lmics. all the doses got swept up pretty rapidly by north american and european countries. this left a huge unvaccinated population gap, so huge numbers of people went unvaccinated on the african continent and in india and southeast asia. a consequence, unfortunately, other than the obvious humanitarian concern, was that delta arose out of an unvaccinated population in india and south asia and omicron out of an unvaccinated or undervaccinated population in southern africa. these were vulnerabilities that were created because of this vaccine equity gap, so our plan was to say, “look, we’ve developed this low-cost technology that we think works as well for sars and mers vaccines; we can now do the same for covid-19.” in fact, we’ve actually done this now—we transferred the technology (without patents) to india and other countries where they’ve scaled up production. in india, the vaccine has been produced at scale by biological e, a vaccine manufacturer based in hyderabad that has produced the vaccine that they call corbevax. so far, it has gone into more than 75 million adolescent arms in india and now is being used as a booster for adults. biological e owns the technology, so it’s a way of decolonizing the vaccine ecosystem by transferring ownership to an lmic vaccine producer. we provide a proof of concept that you do not have to be a multinational pharma company to do big things. we did this through our academic home at texas children’s hospital and baylor college of medicine, our center for vaccine development, in partnership with lmic vaccine producers. we’re hoping to hit the 100 million–dose threshold by the end of 2022 or early 2023. one of our major activities is vaccine diplomacy, working to do the technology transfer of our vaccine technology—without a patent, in this case—to countries such as india, indonesia, and bangladesh and botswana in southern africa. we’ve been doing this largely without a lot of public support in terms of the fact that we were cut out of operation warp speed from the us government and have not really gotten that much support from the g7 countries; we are trying to do this with local governments as well as private philanthropy. corbevax was approved for emergency use authorization last year and first went into adolescent arms starting on march 15th. as i mentioned, now we’ve reached over 75 million doses in adolescents 12 to 14, and the numbers are going up; we’re hoping soon for world health organization approval. biological e, which owns the vaccine, is now pursuing its possible uptake in other lmics. in parallel, we’ve done a similar vaccine antigen in indonesia with their big vaccine producer, biofarma, and it was just announced that this vaccine has been approved for indonesia, where they http://www.amwajournal.org amwajournal.org 9global vaccines and vaccinations: science vs. antiscience call it indovac. because it’s a vegan technology, this will be one of the first halal vaccines for muslim-majority countries, which we’re extremely excited about. now, that’s the good-news aspect of the story. the notso-good news is the fact that, because of 21st century social determinants as well as climate change, we are slowing, halting, or, in some cases, even reversing our global gains, both for control of neglected diseases as well as vaccine-preventable diseases. i’ve written about this in my last book, called preventing the next pandemic: vaccine diplomacy in the time of anti-science. one of the forces i’m particularly concerned about is the rise in antivaccine/antiscience activism, which is really turning out to be aggression. let me give you an example that we’ve seen in this time of covid-19. the official number of deaths for covid is roughly around 5 to 6 million, but some estimates from the institute for health metrics and evaluation, the economist, and others say up to 20 million deaths. the world health organization is now saying 15 million deaths. in the united states, we’ve had 1 million deaths, second only to india. the figure shows the familiar pattern of deaths that many people will recognize that goes through various peaks and valleys as we course through the pandemic. the first peak was 2020 in new york, followed by the summer in texas and the southern states; the big alpha wave was in that terrible winter of 2021, and the delta wave was in the last half of 2021, followed by the omicron wave; then, there’s a big blue arrow in the figure. that big blue arrow points to may 1, 2021, which is the date that the biden administration announced that anyone who wanted to get a covid vaccine could do so, but you can see that the deaths continued afterward. these were individuals who were defiant and refused to get vaccinated because they were victims of antivaccine activists. my estimate is around 200,000 americans needlessly lost their lives because they refused the covid vaccine and became tragic victims to these new, very dark antivaccine activist forces. i want to go there next to explain what’s happening with antivaccine/antiscience activism and aggression because people too often think it’s just some random events that occur on the internet or social media, but it’s far more deliberate than that. let me take you through how i see that the antivaccine/antiscience ecosystem has evolved or devolved. again, i got involved in this being the parent of four adult kids, including rachel, who has autism and intellectual disabilities, and explaining why vaccines did not cause autism, which was version 1.0 of the movement. then, about 7 or 8 years ago, it became more of a political movement rallying around this banner of health freedom/ medical freedom, and now it’s become a full-on globalized empire. i want to finish up by taking you through versions 1.0, 2.0, and 3.0 to help you understand what’s happening with antiscience (box 1). version 1.0, vaccines associated with autism itself, has a lot of complexities. the original assertion, back in a paper published in the lancet in 1998, claimed that the measles/ mumps/rubella (mmr) vaccine had the ability to replicate in the gut of kids, and then that led to autism—or what, at that time, was called pervasive developmental disorder. the scientific community responded in a big way, showing that kids who got the mmr vaccine were no more likely to acquire autism than kids who didn’t. that was very, very important for debunking the assertion, and you would have thought that would be the end of it. but antivaccine groups grew in strength and size and kept on switching up or moving the goalpost in terms of what the actual assertion was; they switched it over to thimerosal preservative in vaccines, spacing vaccines too close together, and alum in vaccines. for a while, they even switched out of autism and said it was the hpv vaccine for cervical cancer or other cancers that was causing infertility or autoimmunity. if that sounds familiar for covid-19 vaccines, that’s where they got it from—they just copy/pasted the false assertion onto covid-19 vaccines. as i said, i got involved in this, having rachel as my youngest daughter, and i detail this in the book, vaccines did not cause rachel’s autism, which was published by johns hopkins university press. it does a deep dive explaining the science of vaccines and the evidence showing there’s no link with autism, but also what autism is and how it begins in early fetal brain development through the action of autism genes. through baylor college of medicine genetics we actually did a whole-exome genomic sequencing on rachel, and my wife and i and were able to identify rachel’s gene associated with autism; it’s involved in neuronal communication, which makes a lot more sense for something like autism. of course, i was heavily targeted by antivaccine activists because of that. they began calling me the og villain—i had to look it up—the original gangster villain. i think it did have some effects on taking some of the wind out of the sails of antivaccine groups, but they found a way to reenergize about 9-10 years ago in a way that i not necessarily would have predicted. it began in southern california, where so many parents had opted their kids out of getting vaccinated that, not surprisingly, it led to a large breakthrough box 1. the antivaccine ecosystem in the united states v.1.0 vaccines and autism v.2.0 vaccines and “health freedom” v.3.0 globalization http://www.amwajournal.org amwajournal.org 10global vaccines and vaccinations: science vs. antiscience measles epidemic in 2014–2015. the california legislature responded appropriately by shutting down vaccine exemptions, and i supported that, but it also led to a backlash under this banner of medical freedom and health freedom, with people saying, “hey, you can’t tell us what to do in terms of vaccinating our kids.” that was fairly disturbing, but it’s what took off, especially in states like texas, where this idea of health freedom or medical freedom got adopted by the republican tea party, and they formed their own political action committee around not getting vaccinated. there was pressure put on the state legislature to make it harder and harder to vaccinate our kids and easier and easier to opt out. as a result, we’re up to almost 100,000 kids not getting all their vaccines in the state of texas, especially around the austin area, and this doesn’t even account for the more than 300,000 homeschooled kids. we have a huge problem now in states like texas, where too many kids are not receiving their vaccines required for school entry. it’s taken this very dark turn in texas and elsewhere. at one point, antivaccine activists paraded with yellow jewish stars at rallies and actually, in my opinion, mocking the holocaust and using words like no vax in letters that look like hebrew letters. i think it’s incredibly offensive and divisive, and yet this is what’s been going on here in texas and elsewhere. and now, in this time of covid-19, it’s accelerated even further among this banner of health freedom/ medical freedom to protest social distancing, contact tracing, and wearing masks. we’ve had some podcasters weigh in, and it’s created quite a dark environment around getting vaccinated, and, of course, this has extended now to covid vaccination. in texas, covid vaccinations have higher rates along the border and some of the cities of the texas triangle, but in the conservative areas of central texas and the panhandle of east texas, there are some of the lowest vaccination rates in the country. it mirrors the political map of texas. the higher-vaccinated areas are in the more liberal/democratic areas, whereas the low vaccination rates are in the more conservative/republican strongholds. it’s really quite striking, and this is what we’re seeing now happening nationally. studies from charles gaba, the health analyst, as well as the new york times, axios, national public radio, and other groups show how in the last half of 2021, the deaths are overwhelmingly in red states, and the redder the county, the lower the vaccination rates and the greater the deaths, so much so that the new york times actually calls it “red covid.” this partisan divide of politicization of people not getting vaccinated is something, for me, that’s been one of the hardest things i’ve ever had to talk about because all our training, as physicians and scientists, says you’re not really supposed to talk about republicans and democrats or liberals or conservatives. but i’ve not found a way to talk about it other than to talk about it in a quest to save lives. everyone’s entitled to their conservative views, but please don’t adopt this one because it’s leading to my estimate that 40,000 texans (and possibly up to 200,000 americans) may have died unnecessarily during this delta wave, and the numbers are continuing among the unvaccinated in the omicron wave. it’s extending now to all childhood vaccinations. there’s a survey looking at how the distrust of covid vaccinations along the partisan divide is extending to all childhood vaccinations, so i’m quite worried about the return of measles and pertussis and other childhood infections. another big concern i have with this is not only the rise of antivaccine activism, but how it parallels antisemitism as well; this has been reported by multiple outlets with people circulating antisemitic flyers blaming jews for covid-19. because i’m jewish, i’m aware of it more than others, and i’m frequently targeted not only for being a scientist but in particular for being a jewish scientist. the emails that i’m getting are pretty frightening, and they often take a very violent tone, such as that i’ll be charged with treason and other crimes against humanity and many expressing their desire to see me executed by various measures. there is also a lot of nazi imagery. i’m sometimes compared to dr. mengele, the infamous nazi doctor who experimented on humans. this has been present not only with me but also my other colleagues—this idea that not only the science is being targeted but the scientists themselves. it’s incredibly offensive stuff, very racist, and white supremacist in nature, with threats the army of patriots will come and hunt me down, very much leaning toward political extremism on the right. this is the new aspect of antivaccine activism—this adoption by far-right extremists—but it’s also coming out of the conservative political action conference (cpac). we http://www.amwajournal.org amwajournal.org 11global vaccines and vaccinations: science vs. antiscience heard it multiple times that first they’re going to vaccinate you, then they’re going to take away your guns and your bibles (https://www.newsweek.com/madison-cawthornsays-door-door-vaccines-could-lead-taking-gunsbibles-1608503). as ridiculous as that sounds to us, there’s a segment of the country who believes it, or members of the house freedom caucus and the us congress comparing people, like myself, whom they call medical brown shirts, using nazi paramilitary analogies. of course, it’s revved up every night on fox news by the nighttime fox news anchors specifically targeting scientists, and these kinds of threats tend to ramp up every time. i’m particularly targeted on fox news. they target dr. fauci a lot, of course, but when they get tired of beating up on tony, i tend to be fauci lite. these are the kinds of threats that i’ll often get after a prominent conservative news site picks this up or if it’s amplified on fox news. so, the question is, what are we facing? what can we do, and what can amwa’s contribution be? well, it’s not easy, because this really does go outside the health sector. it’s become a political problem. but i think it’s important that we at least recognize the problem and its potential for unraveling our biomedical infrastructure. it’s not only vaccines; it gets to covid origins and covid conspiracy theories, and we need to recognize that it’s not an academic discussion—lives are being lost—and this goes way beyond just a theoretical discussion. science and scientists are under attack, and it’s deliberate and organized. these are not random events on the internet. proposing solutions, as i’ve mentioned, is not so straightforward, because so much of this has gone beyond the health sector. the us surgeon general has tried to address this by talking to social media companies, such as meta and twitter, and i think that’s useful, but it doesn’t really get to those generating the content, and that’s the problem. i think we need expertise in political science and other disciplines outside the traditional biomedical sciences to get some help. unfortunately, now it’s going global. we’re seeing this extend up into canada and into western europe. the new york times and bbc report it has been linked to qanon and even neo-nazi groups. this is a globalizing force. my worry now is that with the disruptions from the covid-19 pandemic, we have seen a decline, for the first time, in childhood immunizations. we saw the largest drop in the last 30 years, and we’re even seeing breakthrough polio cases in new york and elsewhere. my worry is that we’re not going to come back to baseline—that something permanent and wrenching has happened. the targeting of scientists, from my view, increasingly looks like what we saw during the ’30s and ’40s in the soviet union under stalin—this kind of targeting of individual scientists seen as enemies of the state. and finally, i think this us-style antivaccine activism—and i’ve written about this in nature reviews immunology—could start reversing global gains and global goals for vaccinating the world’s children. i think this is starting to happen now on the african continent and elsewhere. i think we’re going through a very dark period, with a lot of it coming from authoritarianism on the far right in the united states, but we’re also seeing some of this now among authoritarian regimes in brazil, hungary, and elsewhere. this is a time to recognize the politicization of health, but it’s much more than that. it’s specifically the targeting of scientists and, in the united states, prominent us scientists. i know it’s not the happiest note to end on, but i think it’s an important one. until we can describe it and put our arms around it, it’s hard to combat it. i think, for too long, we’ve seen this as random events on the internet or not really having a huge public health or geopolitical impact, and it’s clear that now it does. thank you, again, for the recognition and the opportunity to speak with you. i look forward to a long association with amwa. thank you so much. acknowledgment i thank kelly byram, writer, editor, and founder of duke city consulting, llc, for her help in bringing the transcript to the page. author declaration and disclosures: the team of scientists at texas children’s hospital center for vaccine development including its co-director, professor peter hotez, is a co-inventor of a covid-19 recombinant protein covid vaccine technology owned by baylor college of medicine (bcm) that was recently licensed by bcm non-exclusively and with no patent restrictions to several companies committed to advance vaccines for lowand middle-income countries. the co-inventors have no involvement in license negotiations conducted by bcm. similar to other research universities, a long-standing bcm policy provides its faculty and staff, who make discoveries that result in a commercial license, a share of any royalty income. to date, bcm has not distributed any royalty income to the co-inventors on the covid-19 recombinant protein vaccine technology. any such distribution will be undertaken in accordance with bcm policy. he is also an inventor on non-revenue-generating patents for neglected tropical disease vaccines. prof. hotez is also the author of several books published by johns hopkins university press and asm-wiley press and receives royalties from those books. author contact: hotez@bcm.edu http://www.amwajournal.org https://www.newsweek.com/madison-cawthorn-says-door-door-vaccines-could-lead-taking-guns-bibles-1608503 https://www.newsweek.com/madison-cawthorn-says-door-door-vaccines-could-lead-taking-guns-bibles-1608503 https://www.newsweek.com/madison-cawthorn-says-door-door-vaccines-could-lead-taking-guns-bibles-1608503 v37 n4 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 46 abstract the american medical writers association (amwa) currently bestows 3 awards in honor of 3 of its members: harold swanberg, md, the founder of the association; walter alvarez, md, in retirement, a nationally syndicated health columnist; and john mcgovern, md, a philanthropist who supported initiatives in biomedical communications. however, the details of the lives of these men are unknown to most amwa members. accordingly, this biography describes the life and accomplishments of amwa’s founder, harold swanberg, to recognize his achievements and to contribute to the history of the profession and of the association. most amwa members have heard of harold swanberg, the association’s founder, but the details of his life are not commonly known. as are those of so many early amwa members, harold’s life is notable for several reasons.1 he contributed to the fields of radiology, scientific publications, medical writing—and chiropractic. he started several organizations in addition to amwa, some of which were charitable foundations supporting college-bound high school students, and founded 3 journals, each of which lasted 50 years. in fact, he was an innovator throughout his life (figure 1). personal life william harold swanberg, bsc, md, facp, was born in philadelphia in 1891.2 details on his early life are scant, but we do know that he was married twice. in 1919, he married zoe johnson (1885? -?), his office assistant at the time,2 with whom he had a son, william h. swanberg, jr (1921-1987). william was likely present when amwa was formed and may have been a member the rest of his life,1 although probably in name only (lillian sablack, former executive director of amwa, telephone conversation, july 24, 2020). his second wife was mildred w. chapman (1901-1987). mildred had 2 daughters, joann spiva kimball (19232021) and mary louise spiva burnham (1926-1999), and she and harold had a daughter, nancy g. bradshaw (19352016). nancy attended francis shimer junior college—at age 15—and, after studying at the sorbonne, received a degree in english from the university of missouri in 1955.3 in the 1960s, she taught medical writing at baylor college of medicine. she became an amwa fellow in 1963.3 early years at age 19, harold was working his way through medical school as an assistant in a histological laboratory when he became interested in “the claims of some of the cults of that period.”4 the laboratory appears to have been that of oakley g. smith, the founder of naprapathy and the chicago naprapathy college.5 (other sources describe harold as being a student of smith,6,7 which may be more self-serving than accurate.) smith himself was a protégé of daniel david palmer, the founder of chiropractic. for whatever chiropractic has become, it originated from palmer’s pseudoscientific beliefs about healing. smith eventually split from palmer in 1907 and founded naprapathy, which focuses on diet and on manipulating connective tissue rather than the spine.7 in 1914, after 4 years of work and at age 23, harold published the intervertebral foramen: an atlas and histological description of an intervertebral foramen and its adjacent parts (chicago scientific publishing; 1914). this book presented the first photomicrographs and scientific descriptions of the intervertebral foramen (in cats).7 a year later, he published the intervertebral foramina in man (chicago scientific publishing; 1915). these books definitively disproved the “stepping-on-the-hose” theory of chiropractic, which was the metaphor for vertebral pressure impinging on nerve cells as the cause of disease.7,8 several legitimate medical journals gave the books good reviews and, despite the books’ conclusions, they were standard works in chiropractic for decades8 and are still sold on alternative medicine websites.9 tom lang / principal, tom lang communications and training international, kirkland, wa william harold swanberg: radiologist, organizer, and philanthropist biography figure 1. william harold swanberg bsc, md, facp (1891-1970), founder of the american medical writers association. http://www.amwajournal.org amwajournal.org 47william harold swanberg: radiologist, organizer, and philanthropist oakley smith had been dissecting spines since 1905, in the interest of chiropractic theory, and harold’s work was related to smith’s investigations.7 a year later, at age 25, harold graduated from the chicago college of medicine and surgery, which is now part of loyola university.2,10 professional years william roentgen discovered x-rays in 1895, 4 years after harold was born.2 thus, this new field of roentgenology was only 20 years old when harold became a physician. he might have been attracted to the field earlier, but in 1917, he enlisted in the army medical corps, received a commission as first lieutenant, and studied at the school of military roentgenology in chicago before being sent to fort riley, kansas. he remained in the army reserves until 1924.2,4 after leaving the military, he moved to quincy, illinois, a small city on the mississippi river. in 1919, he opened the quincy x-ray and radium laboratories.2 soon thereafter, he married his assistant, zoe johnson, and their son william was born.2 as a new radiologist, harold was instrumental in founding the physicians and surgeons radium association of quincy in 1921. the purpose of the association was “to disseminate a knowledge of the use of radium and to maintain hospitals.”2 a short 2 years later, he organized and was elected secretary of the adams county medical society and was the society’s librarian for 30 years. he also suggested that the society publish a monthly bulletin.2 the first issue of the adams county medical society bulletin was published in 1923. eventually, the name was changed to the quincy medical bulletin to “help build quincy into a larger and better medical center.” the bulletin was published until 1970, and at its peak, was sent to hundreds of physicians.2 a year later, in 1924, harold started another journal, the radiologic review, which became the mississippi valley medical journal in 1939. it became clinical medicine in 1960 and was published until 1978.2 harold was also a charter member of the quincy physicians club, a medical study club whose members met twice a month to present and discuss cases.2 the club held an all-day conference every year until the great depression. out of the club would come the mississippi valley medical society.2 over the next several years, harold invented and marketed an applicator for treating gynecological cancers with radiotherapy,11 maintained a private practice, worked as a radiologist at both quincy hospitals and at some of the smaller area hospitals, took a graduate course at harvard, and spent 6 months in graduate studies in vienna (box 1).2 in 1932, he published his third book, radiologic maxims, a collection of sayings and platitudes about radiology box 1. odds and ends of harold swanberg’s life in 1939, as president of the kiwanis club, he suggested quincy high school develop a rifle range and coordinated its development. it was used by both the girls’ and the boys’ rifle teams, the young men’s christian association, the national guard, the catholic youth association, and the quincy kiwanis rifle team.14 (gun clubs were common in high schools at the time, as well as for many years after world war ii.) he created what might have been the first registry of freelance medical writers and editors, eventually expanded so that it could also include “salaried people.”4 he was instrumental in establishing the first vocational guidance program and a guidance counselor position at his local high school in quincy, illinois.1 in the mccarthy era of the 1950s, harold was successful in amending the amwa constitution to exclude anyone in the communist or fascist parties from becoming members. the rationale was “having witnessed the infiltration of other vehicles of communication by subversive forces, it is our duty to safeguard the association against such influences.” the announcement was titled “communists and fascists beware!”4 he served on the board of directors of the unitarian church for many years (a photograph of one of his adopted or to be adopted daughters appears in the same booklet). his last official act appears to have been casting the only vote opposing nonphysicians from becoming president of amwa, an initiative the board felt necessary if the association were to continue. thus, his death also marked the passing of the era that he began 2 decades earlier.25 (the first nonphysician to be elected president was eric martin, phc [pharmaceutical chemist], bsc [bachelor’s degree in pharmaceutical chemistry], ms, phd, who had founded the drug information agency a few years before. hardly a step down from physician presidents.) http://www.amwajournal.org amwajournal.org 48william harold swanberg: radiologist, organizer, and philanthropist (figure 2).13 the book was not well received.13,14 in the 1950s, he also published several articles in the mississippi valley medical journal on medical topics and several editorials on social policy (eg, fluoridation of drinking water, social security) as well as with issues in medical writing.4 in 1935, he helped found the mississippi valley medical society. the 250 charter members elected him secretary treasurer. by 1945, it had 800 members.2 in 1940, he started yet another organization, the mississippi valley medical editors association (mvea), whose purpose was to support the editors of state and local medical society bulletins and the physicians who were writing for these publications.the mvmea was not the first editors’ association, however. to put the mvmea and amwa in context, we have to look at the growth of scientific publishing just after the civil war. the american medical editors association with some notable exceptions (eg, the new england journal of medicine, 1812; the journal of the american medical association [jama], 1883), for most of the 1800s, “medical journalism” consisted of a handful of serious, society sponsored journals (including those from state and local medical societies that would eventually be recruited by the mvmea); many non-society proprietary journals publishing more-or-less legitimate medical articles; and advertising-driven tabloids (today’s “throw-aways”). out of this environment, shortly after the civil war, a group of journal editors formed the american medical editors association (amea) to promote journal editing as a “distinct medical speciality.”15 by the turn of the century, amea had hundreds of members nationwide, many with international reputations,16-19 and was important enough that several leading medical journals published reports on its annual meetings, key papers, and presidential addresses.15 during this period, for the first time, some journal editors became partor fulltime, paid professionals.15 the amea was formed at the 1869 meeting of the american medical association (ama). one of the founders—and its first president—was dr nathan s. davis, the founder of the ama.20 over the years, however, the values of the amea and the ama diverged (box 2). the amea would eventually criticize the business practices of ama presidents george simmons and his hand-picked successor, morris fishbein, who between them directed (read: ruled) the association from 1889 to 1950.21 (both were eventually forced from office for ethics violations, including deceptive business practices.) also, the ama “opposed all health insurance on the grounds that ‘no third party must be permitted to come between the patient and his physician in any medical relation.’”22 in contrast, the amea had long advocated creating a national health department lead by a cabinet-level secretary “to protect the health of the public.”23,24 (the forerunner to the department of health and human services would be established in 1953.) harold was good friends with fishbein, who became an important amwa member. but it is no accident that fishbein disparages the amea as a predecessor to amwa in the very first sentence of his foreword to harold’s history of the american medical writers association.4 that said, fishbein was an ardent supporter of amwa from the beginning and used his influence as “the voice of american physicians” to advance the association. he started the chicago chapter, served as president of the association in 1958, and received the distinguished service award in 1962.25 the amea survived world war i but not the great depression. a similar fate would befall the mvmea, which, to survive, had to evolve into a new organization: amwa. box 2. the american medical editors or writers or authors association in 1928, an organization similar to, or a continuation of (accounts conflict15,20), the amea was formed—the american medical editors and authors association— which appears to have favored the for-profit and throwaway journals who competed with society journals for advertising income. the ama was critical of the new association because its members were publishing “proprietary preparations as have not been approved by the council on pharmacy and chemistry.”20 not said was the fact that the council on pharmacy and chemistry was created and controlled by the ama’s president, george simmons, who awarded its approval to drugs not for their safety and efficacy but for how much the manufacturer advertised in the journal. in 1889, when simmons came to power, the journal’s advertising income was $34,000; by 1909, it was $150,000.21 figure 2. radiologic maxims by william harold swanberg. http://www.amwajournal.org amwajournal.org 49william harold swanberg: radiologist, organizer, and philanthropist the american medical writers association the mvmea did not survive world war ii. the war prevented meetings between 1942 and 1948, at which time interest was waning among the 42 remaining members. harold decided to create a national organization that would be open to everyone in medical publishing, not just to journal editors. to prime the pump, he persuaded his friend, morris fishbein, then editor-in-chief of the journal of the american medical association, to offer a 2-hour course on medical writing at the 1948 meeting. on september 29, 1948, the mississippi valley medical editors association was renamed the american medical writers association, “america’s only association devoted to improvement of the written word of medicine.”4 in founding amwa, harold had several goals, all but one of which were met admirably during his time and some of which continue to drive the association’s activities today. all the successes described below were achieved by volunteers; amwa had no paid staff until lillian sablack became the first executive director of amwa in 1973 (lillian sablack, telephone communication, july 24, 2020). goal 1: publish a bulletin. when the mississippi valley medical editors association was renamed amwa in 1948, it adopted the mississippi valley medical journal as its publication.4 in 1951, amwa also began to publish the quarterly bulletin of the american medical writers association, which was published until 1985, at which time its name was changed to the amwa journal. the mississippi valley medical journal was absorbed by clinical medicine in 1960. the amwa newsletter was published beginning in 1970 and medical communications in 1972.4 in 1978, the newsletter was incorporated into medical communications, and in 1986, medical communications was incorporated into the amwa journal.25 goal 2: start regional chapters. amwa began with 42 members. by 1958, the number was 1,254, and by 1965, more than 1,800.4 by 1965, the association had 9 chapters in the united states and 1 in mexico city. today, more than 4,000 members are included in 16 north american chapters.26 goal 3: bestow awards. early in its existence, amwa established 3 awards. the distinguished service award consisted of a gold medal and a certificate given for “distinguished contributions to the medical literature or rendered unusual and distinguished service to the medical profession.” the first recipient of the distinguished service award was harold himself, in 1952. (the gold medal was discontinued in 1963.)4 the honor award was also a gold medal and a certificate given irregularly for “distinguished contributions to the medical literature.” (that gold medal was discontinued in 1963, too.)4 finally, the honor award for distinguished service in medical journalism was given to medical journals in 6 categories: general medical journals, specialist and research journals, state medical society journals, county or city medical journals, controlled circulation journals, and “other.”4 goal 4: establish fellowships. the association has awarded hundreds of fellowships over the years. notable fellows include morris fishbein and george simmons, editors of the journal of the american medical association; karl menninger, founder of the menninger psychiatric clinic; alton ochsner, founder of the ochsner clinic in new orleans; frances kelsey, the food and drug administration employee who prevented thalidomide from being marketed in the united states; michael e. debakey, the heart surgeon, and his sisters, lois and selma debakey; and joseph garland, editor of the new england journal of medicine.4 goal 5: begin a manuscript editing service. between 1952 until at least 1965, amwa ran a contract editing service for its members to “help maintain and advance high standards of medical literature.” harold proposed the service (of course), which provided line-by-line critiques but did not do library research, compile bibliographies, or provide ghostwriting. the first editor was theodore peterson, a doctoral student at the university of illinois, who, after almost 6 years, had edited 600 manuscripts. the rate was $5 per 1,000 words, and articles were limited to 5,000 words. goal 6: establish college degree programs in “medical journalism.” one of harold’s most important projects was to establish degree programs in “medical journalism.”4 (today, however, “medical journalism” refers to “science writing.”) in 1954, the university of illinois and the university of missouri (in conjunction with their respective medical schools) and later, the university of oklahoma, began offering a bachelor of science degree in medical journalism and writing. the university of illinois program consisted of about an equal number of units in the humanities, social sciences, natural sciences, and journalism. to support these programs, amwa established several “harold swanberg medical journalism scholarships,” funded by http://www.amwajournal.org amwajournal.org 50william harold swanberg: radiologist, organizer, and philanthropist donations (all from harold, of course).4 although harold approached 7 grant-making foundations and sent promotional materials to 250 pharmaceutical, medical publishing, and medical advertising companies, he obtained no outside funding. the programs did not do well. in his history of amwa, harold mentions only 11 students who enrolled in the programs, and only 2 who graduated.4 today, however, several amwa members are or have been closely involved with the medical writing and editing programs at the university of chicago,27 the university of the sciences in philadelphia (although the program ended this year when the university merged with st john’s university), and the university of san diego extension.28 goal 7: offer a traveling lectureship program. from 1955 to 1961, amwa member jacques gray, md, mph, delivered 37 lectures on behalf of amwa at medical centers and pharmaceutical companies on the east coast. gray, a former dean of the medical college of virginia and the medical school at the university of oklahoma, was director at the time of special medical services for park, davis & company, which funded the program. he continued to lecture on amwa’s behalf until his death in 1961.4 goal 8: exhibit at professional meetings. in harold’s history of the american medical writers association is a 1956 photo of him and a colleague recruiting at a booth at the world medical association conference in havana, cuba.4 the exhibit, created by harold (of course) was also shown at several conferences in the united states. in a related project, after one of its own meetings, amwa published a small book titled a group of papers on medical writing.29 the 11 chapters were written by distinguished amwa members. an astounding 20,000 copies were published in 2 editions. the book is still relevant and is available for less than $20. goal 9: nurture sustaining memberships. in 1965, amwa had 26 sustaining members paying an annual fee to support the association. almost all were major pharmaceutical companies, in which amwa members tended to be division heads or vice presidents.4 philanthropic activities in 1942, harold had founded the swanberg medical foundation, a not-for-profit trust fund administered by the adams county medical society, to “sponsor ... things of a charitable, scientific, literary or educational nature... which would bring public and professional honor and respect to the medical profession...”2 eventually, the foundation supported the society for academic achievement (saa), which was “dedicated to motivate youth to achieve academic excellence ... (and) to lead the academically talented to pursue the proper subjects so they can procure a college education and become future intellectual leaders.”2 the foundation and the saa continue to make awards, most recently to seniors at quincy high school. in 1956, harold also developed and launched the quincy major learning program, to help high school students enter and graduate from college.1 his legacy a heart attack ended harold’s medical career in 1959. he died in 1970, at age 79, but not before publishing volume i of a planned 2-volume history of the amwa in 1965.2,4 (volume ii was never written.) in 1962, the association renamed the distinguished service award the harold swanberg distinguished service award. this award is presented “to any active member of amwa who has made distinguished contributions to medical communication or rendered unusual and distinguished services to the medical profession.” in his professional life, harold formed 5 organizations, started 3 journals, and established 3 educational foundations. by founding amwa, he created a structure that would advance the field of medical writing for decades to come. it is fitting that the harold swanberg award is amwa’s highest honor. author declaration and disclosures: the author reports no competing interests in relation to this article. author contact: tomlangcom@aol.com references 1. harvey b. harold swanberg: how i wish i knew you! amwa j. 2019;34(1):18–23. 2. dittmer a. medical writing was a passion for longtime quincy physician. historical society of quincy & adams county website. published february 24, 2019. accessed october 19, 2022. https:// www.hsqac.org/medical-writing-was-a-passion-for-longtimequincy-physician 3. obituary. nancy swanberg bradshaw. legacy website. accessed june 4, 2020. https://www.legacy.com/obituaries/whig/obituary. aspx?n=nancy-swanberg-bradshaw&pid=180120975&fhid=17874 4. swanberg h. history of the american medical writers association and its previous associated organizations. vol 1. society for academic achievement; 1965. 5. a historical review. lucky bodies and happy souls website. accessed july 30, 2020. http://www.luckybodies.com/en/ naprapathy/naprapathy-history 6. ebrall p, murakami, y. constructing a credible case report: assembling your evidence. j contemp chiropr. 2018;1:45-58. http://www.amwajournal.org https://www.hsqac.org/medical-writing-was-a-passion-for-longtime-quincy-physician https://www.hsqac.org/medical-writing-was-a-passion-for-longtime-quincy-physician https://www.hsqac.org/medical-writing-was-a-passion-for-longtime-quincy-physician https://www.legacy.com/obituaries/whig/obituary.aspx?n=nancy-swanberg-bradshaw&pid=180120975&fhid=17874 https://www.legacy.com/obituaries/whig/obituary.aspx?n=nancy-swanberg-bradshaw&pid=180120975&fhid=17874 http://www.luckybodies.com/en/naprapathy/naprapathy-history http://www.luckybodies.com/en/naprapathy/naprapathy-history amwajournal.org 51william harold swanberg: radiologist, organizer, and philanthropist 7. senzon sa. the chiropractic vertebral subluxation part 3: complexity and identity from 1908 to 1915. j chirop humanit. 2019;25:36–51. 8. senzon s. salutogenesis, chiropractic, and medical research. the institute chiropractic website. published may 18, 2019. accessed july 30, 2020. https://www.institutechiro.com/salutogenesischiropractic-and-medical-research/ 9. acupuntureproducts.com. accessed july 27, 2020. https://www. acupunctureproducts.com/ 10. batesel p. american college of medicine and surgery. lost colleges website. accessed july 30, 2020. https://www. lostcolleges.com/american-college-of-medicine-and-surgery 11. swanberg h. a new radium applicator for carcinoma of the cervix. jama. 1928;90(16):1289. 12. quincy high school – shadow yearbook (quincy, il) – class of 1937. e-yearbook website. accessed july 6, 2020. http://www.eyearbook.com/yearbooks/quincy_high_school_shadow_ yearbook/1937/page_58.html 13. radiologic maxims. ind med gaz. 1933;68(7):413–414. 14. radiologic maxims. arch neurpsych. 1933;29(5):1177. 15. connor jj. medical journal editors unite. fugitive leaves blog. published may 24, 2016. accessed june 30, 2020. https://histmed. collegeofphysicians.org/medical-journal-editors-unite/ 16. carney c. biography of henry w. coe. in: history of oregon illustrated; vol 2. the pioneer historical publishing company; 1922. 17. harris s. the nation’s greatest need: a national department of health. am j pub health. 1920;10(8):633–636. 18. saunders eg, maine state library. douglas armour thom correspondence. maine state library special collections; 2015. accessed june 30, 2020. https://digitalmaine.com/ cgi/viewcontent.cgi?article=1597&context=maine_writers_ correspondence 19. estes c. seale harris: remembering alabama’s sugar pioneer. uab magazine website. 2009. accessed october 20, 2022. https://www. uab.edu/uabmagazine/winter2009/cover/sealeharris 20. palmer bb. report of the commission on journalism. j am coll dent. 1935;2(2–3):120–152. 21. ullman d. how the ama got rich & powerful: “the ama’s seal of approval.” huffpost website. published november 10, 2014. accessed june 30, 2020. https://www.huffpost.com/entry/howthe-ama-got-rich-powe_b_6103720 22. millenson ml. medicare, fair pay, and the ama: the forgotten history. healthaffairs website. published september 10, 2015. accessed june 30, 2020. https://www.healthaffairs.org/ do/10.1377/hblog20150910.050461/full/ 23. a medical officer in the president’s cabinet? j abnorm soc psych. 1928;23(3):262–263. 24. wile is. ira solomon wile papers. university of rochester; 1894– 1943. accessed june 12, 2020. https://rbscp.lib.rochester.edu/ finding-aids/aw66 25. schiffrin mj. a history of the amwa journal. amwa j. 2000;15(3): 11–22. accessed october 21, 2022. 26. american medical writers association. amwa website. accessed june 30, 2020. https://www.amwa.org 27. medical writing and editing. university of chicago website. accessed june 30, 2020. https://grahamschool.uchicago.edu/ academic-programs/professional-development/medical-writingand-editing 28. medical writing. uc san diego extended studies website. accessed june 30, 2020. https://extension.ucsd.edu/courses-andprograms/medical-writing-courses 29. gray jp, ed. a group of papers on medical writing. parke, davis & company; 1957. get fit with amwa f ast i nteractive t raining amwa’s fit series helps medical communicators stay healthy. in only 15 minutes—jog your memory, tone your writing muscles, build your core skills, and stretch your knowledge. www.amwa.org/fit only $15 each / approved for .5 ce topics in the series include: } misplaced modifiers } mean, median, and mode } dangling participles } measures of variability http://www.amwajournal.org https://www.institutechiro.com/salutogenesis-chiropractic-and-medical-research/ https://www.institutechiro.com/salutogenesis-chiropractic-and-medical-research/ https://www.acupunctureproducts.com/ https://www.acupunctureproducts.com/ https://www.lostcolleges.com/american-college-of-medicine-and-surgery https://www.lostcolleges.com/american-college-of-medicine-and-surgery http://www.e-yearbook.com/yearbooks/quincy_high_school_shadow_yearbook/1937/page_58.html http://www.e-yearbook.com/yearbooks/quincy_high_school_shadow_yearbook/1937/page_58.html http://www.e-yearbook.com/yearbooks/quincy_high_school_shadow_yearbook/1937/page_58.html https://histmed.collegeofphysicians.org/medical-journal-editors-unite/ https://histmed.collegeofphysicians.org/medical-journal-editors-unite/ https://digitalmaine.com/cgi/viewcontent.cgi?article=1597&context=maine_writers_correspondence https://digitalmaine.com/cgi/viewcontent.cgi?article=1597&context=maine_writers_correspondence https://digitalmaine.com/cgi/viewcontent.cgi?article=1597&context=maine_writers_correspondence https://www.uab.edu/uabmagazine/winter2009/cover/sealeharris https://www.uab.edu/uabmagazine/winter2009/cover/sealeharris https://www.huffpost.com/entry/how-the-ama-got-rich-powe_b_6103720 https://www.huffpost.com/entry/how-the-ama-got-rich-powe_b_6103720 https://www.healthaffairs.org/do/10.1377/hblog20150910.050461/full/ https://www.healthaffairs.org/do/10.1377/hblog20150910.050461/full/ https://rbscp.lib.rochester.edu/finding-aids/aw66 https://rbscp.lib.rochester.edu/finding-aids/aw66 https://www.amwa.org https://grahamschool.uchicago.edu/academic-programs/professional-development/medical-writing-and-editing https://grahamschool.uchicago.edu/academic-programs/professional-development/medical-writing-and-editing https://grahamschool.uchicago.edu/academic-programs/professional-development/medical-writing-and-editing https://extension.ucsd.edu/courses-and-programs/medical-writing-courses https://extension.ucsd.edu/courses-and-programs/medical-writing-courses v37 n4 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 62 international society for medical publication professionals “2023 european meeting of ismpp: fueling creativity” january 24-25, 2023 london, uk https://www.ismpp.org/european-meeting alliance for continuing education in the health professions “the alliance 2023 annual conference” february 6-9, 2023 national harbor, md https://www.acehp.org/your-learning/events american association for the advancement of science “2023 aaas annual meeting” march 2-5, 2023 virtual or washington, dc https://meetings.aaas.org/ dia europe “dia europe 2023” march 22-24, 2023 basel, switzerland https://www.diaglobal.org/flagship/dia-europe-2023 aces: the society for editing “aces evolve: the power of editing” march 23-25, 2023 columbus, oh https://aceseditors.org/conference/aces-2023-columbus american pharmacists association “apha 2023” march 24-27, 2023 phoenix, az https://aphameeting.pharmacist.com/ international society for medical publication professionals “19th annual meeting of ismpp” april 24-26, 2023 washington, dc https://connect.ismpp.org/events/calendar society for technical communication “stc technical communication summit conference & expo” may 14-17, 2023 atlanta, ga https://summit.stc.org/ dia “dia 2023 global annual meeting: illuminate” june 25-29, 2023 boston, ma https://www.diaglobal.org/en/flagship/dia-2023 calendar of meetings http://www.amwajournal.org https://www.ismpp.org/european-meeting https://www.acehp.org/your-learning/events https://meetings.aaas.org/ https://www.diaglobal.org/flagship/dia-europe-2023 https://aceseditors.org/conference/aces-2023-columbus https://aphameeting.pharmacist.com/ https://connect.ismpp.org/events/calendar https://summit.stc.org/ https://www.diaglobal.org/en/flagship/dia-2023 american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. v37 n3 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 42 one of the privileges of serving as president-elect is chairing the nominating committee, which is charged with selecting a slate of officers for the upcoming governance year. it was my pleasure to serve with cyndy kryder, ms, mws; tenille l. lawson, pharmd; erik maclaren, phd; julie munden, ba; jill roberts, ms; theresa e. singleton, phd; and amwa executive director susan krug, ms, cae (ex officio, nonvoting member). i thank my fellow committee members for their insights and critical evaluation of officer candidates for the 2022–2023 governance year. each year interested members are invited to submit a board interest form for consideration of 1 of 3 elected offices: president-elect, secretary, and treasurer. the nominating committee reviews the forms and qualifications of candidates who meet the criteria and collectively agrees on a candidate for each officer position to submit to the amwa board of directors (bod) for consideration. i’m pleased to present the following candidates who were presented to and approved by the amwa bod at the june bod meeting: • president-elect: r. michelle sauer gehring, phd, els • secretary: kimberly korwek, phd • treasurer: julie phelan, mba, md president-elect r. michelle sauer gehring, phd, els, an amwa member since 2009, is in her fourth year on the amwa bod (since the 2018–2019 term) and currently serves as secretary and liaison to the amwa journal. previously, she served on the annual conference planning committee (2013–2020), chaired the committee for the 2019 conference in san diego, and was a member of editor-in-chief search task force. at the chapter level, michelle served as treasurer (2012–2016), program chair/president-elect (2016–2017), and president (2017– 2018) of the southwest chapter as well as chapter conference committee chair from 2015 to 2018. she was awarded an amwa fellowship in 2021. michelle has taught the ethics for science and medicine workshop for amwa. she teaches citations and references for medical writing and ethics for medical writers at the university of california san diego extension. michelle has authored or contributed to multiple journal articles and serves as a peer reviewer. michelle is the senior research scientist for the university of texas health science center at houston's center for advanced heart failure and co-owner of rnaediting, llc. she is the copyeditor of pursue and the managing editor of the vad journal. secretary kimberly korwek, phd, an amwa member since 2010, has been on the amwa bod for 3 years. she is currently the chair of the 2022 annual conference program committee. during the 2019–2020 term, she served as the chapter advisory council chair on the bod, and prior to that she was a member of the chapter advisory council (2017–2019). from 2016 to 2019, she was a section editor, serving on the editorial board for the journal. kim was president of the amwa southeast chapter (2016–2017), serving previously as president-elect (2015–2016). she also served as a chapter delegate to the amwa bod (2016–2017) and the website coordinator for the southeast chapter (2018–2019). kim is the manager of scientific communications within the clinical operations group of hca healthcare. in this role, she is responsible for the management of the portfolio of comparative effectiveness research projects that seek to use data collected within the course of clinical care to improve health care delivery and patient outcomes. kim also manages the development of scientific publications, including manuscripts, abstracts, presentations, and white papers to facilitate the distribution of research findings to internal and external audiences. elise eller, phd / 2021–2022 amwa president-elect slate of officer candidates for the 2022–2023 election amwa news http://www.amwajournal.org amwajournal.org 43slate of officer candidates for the 2022–2023 election treasurer julie phelan, mba, md, an amwa member since 2009, is in her sixth year as treasurer on the amwa bod and chair of the budget & finance committee (2016–2022). she was previously a member of the budget & finance committee (2015– 2016), the communications committee (2014–2015), the 2015 salary survey task force, and the online community and social media committees (2012–2014). at the chapter level, she was president of the greater chicago area chapter (2013–2016), serving previously as president-elect (2012– 2013). she also served as membership chair for the chapter (2011–2015) and as a chapter delegate to the amwa bod (2013–2016). she has authored articles for the amwa journal and currently serves as amwa’s registered agent. she was awarded an amwa fellowship in 2017. julie is the founder and president of biomedisys, inc, a medical communication and strategy consulting boutique in chicago, il. she has more than 20 years of medical communication and business strategy experience including working as a biotechnology equity research associate analyst at robert w. baird & co, medical and strategic advisor for an insurance corporation, and medical communication consultant. procedure for additional nominations as required by amwa’s bylaws (article iv.2e-f), these nominations were announced to the amwa community by email more than 60 days before the annual business meeting. a nominee who is unopposed for any office is declared automatically elected at the annual business meeting. as stated in the bylaws, additional nominations for president-elect, secretary, or treasurer may be made by any member provided the member meet the criteria set forth by the bod. the criteria and process are listed below: • member dues must be current, and the member must be in good standing. • the nomination is submitted in writing to the secretary of amwa at least 30 days in advance of the annual business meeting. this year’s annual business meeting is scheduled on november 5, 2022. • the nomination must clearly state the qualifications of the candidate and be signed by 50 members in good standing as of the date of the receipt of the nomination. • the nomination must be accompanied by a letter from the candidate stating that she or he is willing to serve if elected. www.amwa.org/knowledge_builders knowledge builders build your knowledge on a specific medical communication topic through a variety of elements designed to create an engaging educational experience. listen to a narrated slide set engage in exercises access the handout review the reading list note what you learned explore amwa online learning and get ready to l.e.a.r.n. http://www.amwajournal.org v38 n1 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 18 ann winter-vann, phd director of medical writing services, whitsell innovations, chapel hill, nc kelly kilibarda, phd manager of medical writing, whitsell innovations, chapel hill, nc by allie boman dr kilibarda started out by declaring that, although she and dr winter-vann created it themselves, she was unhappy with the title of her presentation. the word harness, she said, implies that attention is outside of yourself and you need to catch it. rather, like happiness, attention is already within you. thus, a better title would be “how to cultivate attention for productivity and deep work.” dr kilibarda, and later dr winter-vann, presented a curated set of attention theories and practices, rich with lived experience and tangible ideas for implementation. first, dr kilibarda challenged the idea that work and play exist on opposite sides of the spectrum of unenjoyment to enjoyment. she decried this idea as a false binary and encouraged a more holistic view of work as expression and productivity. we can increase the enjoyment and fulfillment of our work by cultivating our attention. in doing so, we create contexts in which we access and produce the best we have to give. without some intentionality, however, we may remain in shallow work—tasks that require little cognitive power but take time—for most of the day or week. shallow work is often visible to others and holds some value, but it can easily be replicated by others. in contrast, deep work provides a context for enjoyable, fruitful productivity. summarizing cal newport and others, dr kilibarda described deep work as a distraction-free state requiring cognitive power, concentration, and endurance. by training ourselves to regularly enter into deep work, we access and produce that which we alone can contribute. we create space for offering our true value. dr kilibarda explained that the sweet spot for deep work is 90 minutes without interruption. it takes training and practice to be able to concentrate for this long, but learning to do so is key to contributing our best work. she stated that the average worker wants about 8–10 hours of uninterrupted deep work per week. however, managers and teams tend to undervalue long periods without interruption because it appears as though little is being accomplished. therefore, maintaining this practice at work requires self-advocacy. dr winter-vann built on the theory of deep work, covering how to cultivate attention practically. how to cultivate deep work • prioritize tasks using eisenhower’s urgent/important matrix • plan time blocks, building space in your schedule for deep work • communicate when you are entering a deep work block, so people won’t expect an instant response from you • enforce boundaries—don’t agree to meetings during your planned deep work times • shut off notifications (use “do not disturb” on your devices, etc.) • create a routine around deep work sessions (signal to your brain that it’s time to do deep work; similar to bedtime rituals for children) • rest between sessions of deep work • audit your time—how does what you did compare with what you planned to do? how to minimize shallow work • automate/delegate low-importance tasks • set reminders to release yourself from needing to remember details (e.g., set an alarm for when it’s time to leave work to pick up your kid from school) • compress the time allotted to answering emails, etc. (e.g., plan a 30-minute session for responding to messages) session report attention!: how to harness it for productivity and deep work conference http://www.amwajournal.org amwajournal.org 19attention!: how to harness it for productivity and deep work • normalize unavailability—counter the expectation that you will respond to messages immediately dr kilibarda emphasized the value of getting into a flow state via deep work. the idea is to be so immersed in your work that time disappears. some tedium is required for reaching this state, partially because we are used to dopamine fixes: when we rely on instant rewards through easy tasks and distractions, we are feeding our brain dysfunction. so part of mastery in deep work is getting used to boredom, which angela duckworth says is very tiring! this is why rest after a session of deep work is crucial, even if it doesn’t look like we’ve accomplished much. finally, dr winter-vann reiterated the difference between shallow and deep work: shallow work doesn’t take much skill. it might require a few weeks to train someone to do it. (in fact, you might consider training someone to take over some of your shallow work!) deep work, however, accesses the skills and knowledge that you have developed over months and years. it is in this context that you bring forth your unique value on the job and in your world. allie boman is lead editor at boman editing in highwood, il. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: allie@bomanediting.com brian bass, mwc is our 2022 golden apple award winner! kelly byram, ms, mba, els (left) receives the 2022 amwa president’s award from katrina r. burton, bs. julia forjanic klapproth, phd (left) receives the 2022 harold swanberg distinguished service award from sarah dobney, mph. http://www.amwajournal.org amwajournal.org 59researching medical devices using publicly available databases resources for researching medical devices using publicly available databases speaker sara vanwyk, mph, ccrp, rac, mwc / clinical evaluation reporting, llc, st. petersburg, fl by thi nguyen, bs the clinical evaluation of medical devices marketed in the european union (eu) is influenced by guidance from the medical device coordination group (mdcg) and still-relevant sections of meddev 2.7/1 rev 4 (medical devices document 2.7/1 revision 4; june 2016). in her presentation at the 2022 amwa southeast regional conference, sara vanwyk provided an overview of relevant guidance on the clinical evaluation report, publicly available databases for literature searches, and content and release information for summaries of safety and clinical performance (sscps). background historically, requirements for medical device regulation in europe were established by the medical devices directive (mdd) and the active implantable medical device directive (aimdd). as of late, the requirements have been transitioning to follow the medical devices regulation (mdr) and in vitro diagnostic regulation (ivdr). to show evidence of having met the eu mdr general safety and performance requirements, manufacturers plan and report on the clinical evaluation of medical devices marketed in the eu; such evaluations align with the meddev and mdcg guidance documents, including meddev 2.7/1 rev 4, mdcg 2020-6, and mdcg 2020-13 (among others). the first relevant guidance is meddev 2.7/1 rev. 4 (june 2016), which offers manufacturers and notified bodies guidance on clinical evaluation under directives 93/42/eec and 90/385/eec. the second guidance is mdcg 2020-6, which explains sufficient clinical evidence for legacy devices. the third guidance is mdcg 2020-13, which offers a template for the clinical evaluation assessment report (cear). each section of guidance contains pearls of wisdom regarding the device characteristics and evidence described in a clinical evaluation report, including the device description, published literature, clinical investigations, and clinical experience. this information may additionally be described in an sscp, depending on the type of device. device description methods for describing the device under evaluation are outlined in mdcg 2020-13 section c. to locate a device description, one can use the manufacturer’s website, the united states (us) food and drug administration (fda) 510(k) premarket notification database (https://www. accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm), the fda premarket approval (pma) database, or the therapeutic goods administration (tga) australian registry of therapeutic goods (artg) database. published literature what literature qualifies for evaluation depends on the associated data, which can be categorized as either pivotal data or other data according to section 9.3.2 of meddev 2.7/1 rev 4. pivotal data must directly demonstrate adequate safety and performance (of sufficient quality and generated with the device under evaluation or the equivalent), whereas other data only play a supportive role. the same guidance also offers examples of data that lack scientific validity in appendix a6. in terms of where to find published literature, many options exist, and ms vanwyk highly recommends pubmed, embase, and the cochrane database for systematic reviews. however, other databases such as europe pmc and google scholar can also be viable options. clinical investigations in addition to searching published literature, writers are also encouraged to search data from clinical investigations. this search can help writers identify data that are not found by other means. to find clinical investigation data, writers can use clinicaltrials.gov, the world health organization international clinical trials registry platform (who ictrp), and cochrane central, although the eu clinical trials register can also be a good resource. clinical experience clinical experience includes data on suspected device-associated deaths, serious injuries, and malfunctions that can feed into medical device reports (used in the us) and medical device vigilance (used in the eu). in the us, the fda can use clinical experience to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments. data can be compiled from mandatory reporters (eg, manufacturers, importers, and user facilities) and voluntary reporters (eg, health care professionals, patients, and consumers). it is important to note that clinical experience can have limited utility because of passive surveillance. many clinical experience databases exist throughout the world, with the us having the most databases. available databases per country are as follows: • us – fda manufacturer and user device experience (maude), fda recalls, and fda total product life cycle (tplc) databases http://www.amwajournal.org https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm amwajournal.org 60think like an editor: improving document quality for regulatory submissions • canada – health canada medical device incidents and health canada recalls and safety alerts databases • united kingdom – medicines and healthcare products regulatory agency (mhra) database • germany – federal institute for drugs and medical devices (bfarm) field corrective actions and bfarm recommendations databases • switzerland – swissmedic field safety and corrective actions (fsca) and swissmedic recalls databases • australia – tga device adverse even notification (daen) and tga system for australian recall actions (sara) databases other resources other helpful resources include sscps, which provide publicly accessible, up-to-date summaries of clinical data and other information about the safety and clinical performance of a medical device. sscp information can be accessed through https://ec.europa.eu/tools/eudamed/#/ screen/home. thi nguyen is a medical writer at icon plc based in fort lauderdale, fl. author contact: h.nguyen15@umiami.edu think like an editor: improving document quality for regulatory submissions speaker callie compton, ma / senior technical editor, certara synchrogenix, nashville, tn by paris karr, pharmd quality control (qc) is an integral part of ensuring accurate and consistent regulatory writing submissions. qc can be essentially defined as a process of checking consistency against a standard. however, in a writing context, qc is more specific than just “review.” considering different types of reviews (data, subject matter expert [sme], and editorial), the omission of each kind can have different implications. data and sme reviews can be critical for regulatory submissions, whereas an editorial review is often necessary for document appearance. in her presentation at amwa’s 2022 southeast regional conference, callie compton, senior technical editor at certara synchrogenix, identified common issues in the qc process and discussed strategies for regulatory medical writers to ensure a successful qc process. common issues compton began by outlining several examples of document inconsistency. such instances can include (but are not limited to) a document not aligning with sources, inconsistent terminology and style conventions, and errors in grammar, punctuation, and/or spelling. furthermore, she also identified issues that may arise downstream in the qc process, such as inadequate time allotted for qc, vague, unclear expectations and/or instructions, and misplaced expectations for role/review type. document consistency compton suggested that identifying specific standards that govern the document is a crucial step for qc. however, before the actual process of qc, regulatory medical writers should consider asking the following questions to ensure document consistency: • does my writing align with its source(s)? • is my writing easy to navigate? • do i write about the same content in the same way? • do the same components in my writing look the same? regulatory writing may often require checking external sources such as a tables, listings, and figures document or a clinical study report. to ensure that the writing is aligned with external content, it is important to clearly identify sources in the document and to keep them organized. compton illustrated that source references should specify document identifiers, such as the study identification, version number, or date, if applicable. consistent terminology and style conventions are also critical for regulatory documents. compton pointed out that a style guide can be an important tool to help maintain uniformity when there can be many acceptable writing conventions. a style guide may specify, for instance, • use of company/drug name • preferred template/toolbar • abbreviations/terminology, and/or • usage (eg, patient vs subject). compton elaborated that “style” may refer to 2 different things: writing composition or formatting. in discussing the latter, a qc checklist can help guide the medical writer to consistently perform specific assessments, line edits, and spelling checks as a process. qc process given its deadline-oriented and collaborative aspects, regulatory writing requires effective time management. compton pointed out that inadequate time allotments for qc during development stages or at the end of a project can lead to considerable quality risk. for that reason, the start of http://www.amwajournal.org https://ec.europa.eu/tools/eudamed/#/screen/home https://ec.europa.eu/tools/eudamed/#/screen/home v38 n3 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 40 the walter c. alvarez award is bestowed on a member or nonmember of amwa to recognize excellence in communicating health care developments and concepts to the public. as chair of the 2023 annual conference committee, i have the honor of bestowing this year's walter c. alvarez award upon katelyn jetelina, phd, mph. like many of us, dr jetelina discovered her love for writing and for sharing scientific concepts with the public almost by accident. in 2020, during the covid-19 pandemic, she worked as a senior scientific consultant at meadows mental health policy institute, a nonpartisan health policy think tank, and she also consulted with several organizations, including the us centers for disease control and prevention. but at night, after her children went to sleep, dr jetelina started writing about public health science. her passionate work to bridge the communication gaps between the public, patients, doctors, and researchers led to a newsletter to help ordinary people be "well equipped to make evidence-based decisions." and what started as a side hustle driven by passion and compassion grew over the next 3 years. dr jetelina's substack publication, "your local epidemiologist," now reaches more than 190,000 subscribers in 126 countries. now renowned for translating public health science into everyday language, dr jetelina is taking a break from her scientific work. she is focusing full-time on processing and translating scientific knowledge for the public. dr jetelina's newsletter topics range from infectious diseases and vaccines to reproductive health and violence to mental health and public health emergencies. the thread that runs through them all is her clear explanation of statistical analysis that transforms the profound scientific ideas into understandable chunks of information and actionable suggestions. please join me in congratulating dr jetelina, our walter c. alvarez award winner, and listening to her talk on saturday, october 28, at the 2023 medical writing & communication conference in baltimore. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: michele@sequeiramedicalwriting.com michele w. sequeira, ms, mba, mwc / 2023 annual conference committee chair 2023 walter c. alvarez award recipient katelyn jetelina, phd, mph amwa news dr jetelina's newsletter topics range from infectious diseases and vaccines to reproductive health and violence to mental health and public health emergencies. http://www.amwajournal.org https://yourlocalepidemiologist.substack.com/archive v37 n4 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 19 the panel members respond to questions that have been raised during sessions on different developments in using technology in medical writing. medical writing is a profession dedicated to transforming data and analyses into useful and digestible information, whether that information involves regulatory applications or documents for the public and, specifically, patients. decisions about treatments or granting of approvals depend on the distillation being accurate, clear, and understandable. using available technology well can support this goal in that it is a means for shifting a writer’s focus from what can be accomplished by artificial intelligence (ai), machine learning, and functions to the creation of content. what are the drivers for using aspects of automation in medical writing, what gaps has it filled? helle gawrylewski: in the pharmaceutical industry and in health care, automation in the writing process has spotty adoption depending on the size and digital sophistication of a company. automations have been used effectively in writing by templates in which sections are prepopulated based on text from other documents. the protocol might be populated with text from the investigator’s brochure (ib) or protocol concept document. some companies have developed or acquired systems that can be used to accomplish this type of text before population and reuse. microsoft word itself has some slick automated capabilities that may not be fully used, like text tagging for reuse in other parts of a document. another gap filled is the writing of routine text in documents like the safety narratives in clinical study reports (csrs). narratives are required in the csr but are onerous to write, especially in cases in which there are many variables or many study participants with adverse events as in an oncology study. us food and drug administration (fda) reviewers have not been fond of safety narratives being totally written by automation, so this is not as common as it might be. but hybrid narratives, in which the data appear in brief tables and the discussion and assessment are written by a medical writer, can be efficient and accurate and medically useful. safety narratives written entirely by ai require a large data set to teach the algorithms to produce adequate text. the writing process also has benefitted from automation in review tools and quality control (qc). it’s useful for the applicable style manual to be digitally available and automatically applied for document checking. routine checks can be more efficient this way and a time-saver for the writer. tools for the review cycle have also been used because it’s tedious to send out sequential versions for document review when this can be done by a tool like please review and others, in which all comments can be seen by the team, tracked, and ultimately incorporated. technology improves the process immensely and has had a positive impact not only on efficiency but also quality. other parts of an ectd (electronic common technical document) have also benefitted by making the integrated summaries of safety and effectiveness (iss and ise) linked to the individual reports for a population, and the literature summaries can be captured by ai technology. i’m not sure how many companies take advantage of ai in this respect, but nimita can perhaps address this more fully. other options for the use of ai and deep learning can be technical summaries of results for registries, and these can be populated when a csr is written, as can the fda study snapshots for safety by demographic characteristics that are required at approval. it’s possible to populate the requirements automatically as an application is being built. scientific writing in another language, also referred to as translation or localization, benefits from at least some aspects of machine translation. companies that use translation memories, machine learning, or advanced deep learning methods (also known as deep structured learning, with multiple layers between the input and output layers) can produce complex documents in many languages quickly, required for lay summaries in the european union (eu) portal (implemented in january 2022). this helle gawrylewski, ma1 and nimita limaye, phd2/ 1former senior director, global regulatory writing, johnson & johnson, new hope, pa; 2vice president, research, idc health insights, needham, ma technology to further medical writing: status and future vision theme article http://www.amwajournal.org amwajournal.org 20technology to further medical writing: status and future vision type of automation requires standardization of concepts and terms so that coding can be used for digital exchange. groups like the clinical data interchange standards consortium (cdisc) and the medical dictionary for regulatory activities (meddra) code research terms and adverse events so they can be easily exchanged. all of these uses require standardization of terms and definitions. a concept that assists in reusing information: text must also be considered data. written content is data, and a document is just a compilation of data elements. computer systems can be designed to use natural language processing (nlp) to understand written text. machine learning and deep learning keep advancing, making these tools a substantial efficiency gain for any organization. it’s also a boon to medical writers who can use the tools to summarize large amounts of data to ensure that all applicable resources are considered. nimita limaye: helle has made some great points. the future of medical writing is really about automation with the human in the loop. it is about leveraging not only robotic process automation and ai, but also about the use of machine learning (ml) techniques, such as nlp (which turns text into structured data) and natural language generation (which turns structured data into text). the challenge with training ml algorithms is the availability of massive labeled data sets. transformer-based neural network architectures operate in a two-stage process, unsupervised learning on large volumes of unlabeled datasets, and then supervised learning on smaller amounts of labeled data. these are very powerful models and can be game changers, but these are still early days. there has been a very interesting report in the june 2022 edition of scientific american about how a gpt-3 transformer was trained to write an academic paper about itself. automation will bring in significant efficiencies and reduce not only costs, but will also reduce the monotony associated with authoring the often-repetitive sections associated with regulatory documents and will improve quality. one is seeing a flurry of innovation, with technology vendors actively innovating to drive “intelligent authoring.” technology in medical writing will be increasingly adopted by the life sciences industry, and the future is not about the why, it is about the how. it is about how do you successfully implement it at scale. the industry is still stuck in a “pilotitis” mode, that is, operating on running one pilot to see if the technology really works, which is not surprising because it is such a highly regulated industry. what are the areas in which use of the technologies might not be the best option and what barriers still exist in the industry? helle gawrylewski: aspects that require expert scientific knowledge and assessment may be able to be produced by automation but at this time still require human evaluation and judgment. electronically translated text still needs human review because language nuances and cultural aspects are difficult to program, especially in many languages. a native speaker should always review and verify. writers work in a global arena and should take this responsibility very seriously. for safety narratives, the medical assessment is also better written by a qualified medical writer. machine written text can take on a repetitive quality and be interpreted as obviously machine written and not properly evaluated. nimita limaye: absolutely—addressing scientific and cultural nuances is critical. and i believe that writing is not just a science, it is an art. the sentience that a human can bring in can make all the difference, especially when it comes to developing lay summaries or building out informed consent forms. in addition, interpreting findings often requires looking across multiple data points, possibly in different reports. algorithms may not be configured to do that. this is where the scientific thinking that a medical writer brings to the table counts. what barriers to adoption exist in the industry? helle gawrylewski: structured authoring has been difficult to adopt because the application initially did not support word documents and the formatting was an issue. using structured authoring requires staff training and often an authoring tool does not integrate well with other older systems. it’s easier for a new operation or initial public offering (ipo) to start with structured authoring than to have a large organization scrap all the old systems and replace them. cost is definitely an issue but also technical competency of the staff. even word is not actually used to its full capacity! document experts are often not writers, and many writers are not sophisticated technology experts! in the past writers have been reluctant to embrace automation because they think it will replace them. but the fact is that not everything they write is worthy of their full attention. so, offloading what can be offloaded allows full-time focus on the critically important document sections and elements. http://www.amwajournal.org amwajournal.org 21technology to further medical writing: status and future vision there are some specific phases of research or types of research documentation for which automation seems to be more useful than for others. in early phase 1 studies, much of the results are focused on data and assessments are straightforward, like blood levels for cmax, auc, and such. wearable devices that record results digitally are ideal in many types of studies in which tracking is important and in which some participants can be unreliable, such as in cardiac and diabetes studies. automation of patient diaries has always been a good use of automation, and now it’s possible to use smartphones and audio recording to get quality real-time data. nimita limaye: i think that the biggest barriers to adoption are change management and “pilotitis.” automation creates concerns with many medical writers. will their roles be replaced? no, not really. they will actually move up the value chain. the grunt work will be taken care of by ai/ml. the medical writer will need to ensure that the data are represented in the right way, are being interpreted appropriately, and that the messaging is correct. it is important that the value of automation of medical writing is recognized. secondly, implementing any technology requires investment, and returns come when the solution is implemented at scale. hence, many times, companies do not see the returns after running a pilot, and then determine that this is not a good solution. that should not happen. skill development is also important. not everyone is tech-savvy, and the ability to navigate various tools requires training. ensuring transparency and regulatory compliance will be critical. what promising developments in automation exist in the near future as advances in ai and deep learning technologies continue to evolve? helle gawrylewski: access to efficient and useful information from large databases that are untapped and useless to regular human review, like clintrial.gov, can have considerable impact. how many people can review and get value from all of the studies registered and reported there? the information is only as useful as we can accurately search and summarize it using ai and other newer methods of deep learning. i’ve seen it done and can say that it’s exciting and not used nearly as much as it could be. the same applies to the eu portal that will contain not only csrs but entire applications and ibs. workflows can be made efficient and accurate using automation and ai by an authoring system that reuses, and is connected with, all data elements linked for easy searching, correcting, and replication. providing drug labels globally in all native languages that are accurate (and correspond with the master label), accurately translated, localized, and kept up to date in a master system for tracking and updating. i hope this will be more common than it is now. i think an ai and deep learning system to render research into plain language to make it accessible to the public could be a remarkable way to counter misinformation and shine a light on all the great scientific research that goes on but is inaccessible to most. it’s said that the vaccines were developed so quickly that they can’t be safe—wrong! the platforms were used for years before for other vaccine development, especially the standard ones used for ebola and tuberculosis, but the public finds it hard to follow or understand what goes on in research. and we need to modernize regulatory processes and health authority reviews, continue to have applications and data digitally accessible and reviewable globally. if we are transparent and share, scientific data will help us make better decisions faster and promote not only cures but the prevention and avoidance of disease. nimita limaye: one will see the increasing use of realworld data; data will be flowing in, fast and furious. it will be extremely challenging for medical writers to handle this scale and speed. this is where technology will play a valuable role. in addition, as global regulations keep evolving, dynamic document templates that embed this intelligence real-time will reshape the future of medical writing. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: nlimaye@idc.com biosummaries helle gawrylewski has a ma from university of pennsylvania, is a woodrow wilson fellow, and is a former senior director in global regulatory and medical writing at johnson & johnson (j&j) (retired). her experience in regulatory medical writing and global regulatory affairs spans more than 49 years in the pharmaceutical industry at hoechst roussel pharma, novo nordisk, and janssen research and development of j&j. during that time, gawrylewski was directly involved with 55+ regulatory applications for marketing approval and in all aspects of product life-cycle development, ranging from early to full development and post-marketing medical affairs. http://www.amwajournal.org amwajournal.org 22technology to further medical writing: status and future vision she managed and mentored staff from two to 125 and is a strong proponent and advocate of regulatory medical writing. she established linguistic services like translation and related global partnerships in medical and regulatory writing, leading outsourcing relationships in india and china and worked on the first team to submit a drug application electronically to the fda. she led document management implementation and transparency activities internally while serving as a team lead at transcelerate in the clinical trial document transparency group, later in phuse as a team member, and also on teams at janssen that produced several european medicines agency policy 0070 submissions of transparent clinical reports. in regulatory, she established global labeling outsourcing. externally, gawrylewski was the pharmaceutical research and manufacturers of america representative in the ich e3 q&a working group that clarified standards for study reports, was a member of the cdisc glossary team and was the lead for 7 years, and was dia mw community lead for and a core team member for 8 years. gawrylewski is dedicated to cross-industry groups designing approaches to common problems in clinical trials, including clear goals/design, auditable conduct, subsequent clear reports, and transparent results in plain language and well-defined scientific terms shared in multiple languages. she is a member of the multi-regional clinical trials plain language glossary effort, the phuse transparency term harmonization team, and contributed 2 chapters to the regulatory affairs professionals society’s regulatory writing: an overview. experience shows that such work allows medical knowledge to advance and ultimately to make a difference in patients’ lives. nimita limaye, phd, is a vice president of research with idc health insights and leads life sciences research and development strategy and technology, providing researchbased advisory and consulting services as well as market analysis on key topics related to the life sciences industry with a technology lens. she is an executive business leader with over 25 years of experience working in the pharmaceutical, contact research organization, and life sciences technology consulting industries. she is the past chair of the society for clinical data management board and is the current chair of the global dia medical writing community. she has chaired several conferences, led industry roundtables, given keynotes, and has authored close to 100 publications and white papers. limaye has led medical writing operations, managed strategic outsourced partnerships, and has conducted workshops on the outsourcing of medical writing. a career in medical communication: steps to success learn about the skills and attributes needed to be a successful medical communicator and discover opportunities in the field. www.amwa.org/career_steps http://www.amwajournal.org listen to our podcast available on apple podcasts, google podcasts, and spotify become a medical writing master visit us at trilogywriting.com writers@trilogywriting.com www.trilogywriting.com/trilotalk think you have what it takes to join a world-leading team of medical writers? we’d love to speak with you. v38 n3 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 36 this year, i am honored to serve as president-elect for the american medical writers association. as such, i chair the nominating committee, which is charged with selecting a slate of officers for the upcoming governance year. each year, any interested amwa member is invited to submit a board interest form for consideration of 1 of 3 elected offices: president-elect, secretary, and treasurer. the nominating committee reviews the forms and qualifications of candidates who meet the criteria and collectively agrees on a candidate for each officer position to submit to the amwa board of directors (bod) for consideration. i want to extend my gratitude to those who volunteered their time and expertise to serve alongside me as committee members: • cyndy kryder, ms, mws • tenille l. lawson, pharmd, bcps • brian bass, mwc • gail v. flores, phd • theresa e. singleton, phd • leslie nielstat, els • susan krug, ms, cae (ex officio, nonvoting member) this year’s committee consists of past amwa presidents and board members as well as members who have served in leadership positions in the medical communication field. we received multiple strong applications for the executive committee, and the nominating committee’s insightful feedback and critical analysis allowed for robust discussion and a strong slate of officer candidates. i respectfully present the following candidates who were presented to and approved by the amwa bod at the june bod meeting: • president-elect: shawn watson, pharmd, phd, bcps, rph, bspharm • secretary: kimberly korwek, phd • treasurer: julie phelan, mba, md president-elect shawn watson, pharmd, phd, bcps, rph, bspharm, has been an amwa member since 2012. he has served on the board as a director at large since 2019. shawn has served on the diversity and inclusion assessment task force and as the liaison for the engage committee. he has assisted with the virtual conferences and publications on salary surveys. dr watson has also served on the national nominating committee (2018-2019) and the national educational committee (2018-2019). at the chapter level, shawn served as president (20172018), immediate past president (2018-2019), and chapter delegate (2015-2017) of the new england chapter; he also served on the chapter nominating committee from 2017 to 2019. shawn has authored or contributed to multiple amwa journal articles and has led roundtables and sessions at the chapter and national conference level. shawn is currently a senior director of clinical development, program team lead, and interim head of medical writing at recursion pharmaceuticals. secretary kimberly korwek, phd, an amwa member since 2010, has been on the amwa bod for 4 years. she is currently the 2022-2023 secretary. she previously served as the chair of the 2022 annual conference program committee. during the 2019 2020 term, she served as the chapter advisory council chair on the bod, and prior to that, she was a member of the chapter advisory council (2017-2019). from 2016 to 2019, she was a section editor, serving on the editorial board for the amwa journal. kim r. michelle sauer gehring, phd, els / 2022-2023 amwa president-elect officer candidate slate for the 2023-2024 election amwa news http://www.amwajournal.org amwajournal.org 37officer candidate slate for the 2023-2024 election was president of the amwa southeast chapter (20162017), serving previously as president-elect (2015-2016). she also served as a chapter delegate to the amwa board (2016-2017) and the website coordinator for the southeast chapter (2018-2019). kim is the manager of scientific communications within the clinical operations group of hca healthcare. in this role, she is responsible for the management of the portfolio of comparative effectiveness research projects that seek to use data collected within the course of clinical care to improve health care delivery and patient outcomes. kim also manages the development of scientific publications, including manuscripts, abstracts, presentations, and white papers, to facilitate the distribution of research findings to internal and external audiences. treasurer julie phelan, md, mba, an amwa member since 2009, is in her seventh year as treasurer on the bod and as chair of the budget & finance committee (2016-2023). she was previously a member of the budget & finance committee (20152016), the communications committee (2014-2015), the 2015 salary survey task force, and the online community and social media committees (2012-2014). at the chapter level, she was president of the greater chicago area chapter (2013-2016), serving previously as president-elect (2012-2013). she also served as membership chair for the chapter (2011-2015) and as a chapter delegate to the board (2013-2016). she has authored articles for the amwa journal and currently serves as amwa’s registered agent. she was awarded an amwa fellowship in 2017. julie is the founder and president of biomedisys, inc, a medical communication and strategy consulting boutique in chicago, il. she has more than 20 years of medical communication and business strategy experience, including working as a biotechnology equity research associate analyst at robert w. baird & co, medical and strategic advisor for an insurance corporation, and medical communication consultant. procedure for additional nominations as required by amwa’s bylaws (article iv.2e-f), these nominations were announced to the amwa community by email more than 60 days before the annual business meeting. a nominee who is unopposed for any office is declared automatically elected at the annual business meeting. as stated in the bylaws, additional nominations for president-elect, secretary, or treasurer may be made by any member provided the member meets the criteria set forth by the bod. the criteria and process are listed as follows: • member dues must be current, and the member must be in good standing. • the nomination must be submitted in writing to the secretary of amwa at least 30 days in advance of the annual business meeting. this year’s annual business meeting is scheduled for october 28, 2023. • the nomination must clearly state the qualifications of the candidate and be signed by 50 members in good standing as of the date of the receipt of the nomination. • the nomination must be accompanied by a letter from the candidate stating that they are willing to serve if elected. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: michelle@rnaeditingllc.com http://www.amwajournal.org v38 n1 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 27 haifa kassis, md crisp writing, boston, ma donald harting, ma, ms, els, chcp harting communications llc, downingtown, pa by jerm day-storms, phd, mwc continuing education in the health professions (cehp), including continuing medical education (cme), is a vitally important and fast-changing field in which medical writers can find challenging and rewarding work. the field draws its importance from the way all stakeholders work together to provide clinicians with the up-to-date knowledge and skills they need to improve patient health outcomes. cehp providers include a broad range of organizations, including health systems, medical schools, and government agencies, but freelance medical writers most often work with private medical education (med-ed) companies and medical specialty societies. cehp is a growing industry. according to statistics kept by the accreditation council for continuing medical education (accme), the industry reported $2.81 billion in total income in 2021. of that amount, $895 million came in the form of commercial support from large pharmaceutical and medical device companies, a sharp increase from $723 million the previous year.1 medical writers help preserve integrity to distinguish it from advertising, cehp instructional content must be accredited by a third party, such as the accme at the national level or one of its designees at the state level. individual med-ed companies may also apply to the accme for the right to bestow continuing education (ce) credit upon clinicians who complete their courses. the accme endorses a system for the commercial support of cehp that aims to protect its integrity by erecting a firewall between commercial interests and the expert faculty who deliver instruction to learners. in standard 2 of its standards for integrity and independence in accredited continuing education, the accme states, “the accredited provider must ensure that all decisions related to the planning, faculty selection, delivery, and evaluation of accredited education are made without any influence or involvement from the owners and employees of an ineligible company.”2 in this system, pharmaceutical companies and medical device companies are ineligible to award ce credits, but they are free to provide commercial support so long as they comply with accme standards. the medical writer provides services to the med-ed company developing the accredited program. this program includes a curriculum overseen by expert faculty. the medical writer must not be influenced by any commercial supporter so that the integrity of the program remains intact at each step of the content development process, from the grant proposal to the outcome report. before a program can be developed, a proposal is written and submitted to obtain funding. the proposal must justify why the commercial supporter should give money to the med-ed company or specialty society. a typical proposal consists of a program agenda, an outcomes measurement plan, a budget, a delivery schedule, credit information, an audience generation plan, and a needs assessment (na). med-ed companies often outsource these nas to freelance medical writers. a strong na is usually built around a core literature review, but it may also include several other types of evidence showing why clinicians need to learn about a particular topic. the narrative of a well-written na will describe one or more gaps between optimal clinical practice (e.g., as laid out in practice guidelines) and actual clinical practice as observed in the field. the na serves as the basis for developing the learning objectives for the proposed program, and these objectives in turn justify the agenda, instructional content, and faculty selection. after a proposal is funded, medical writers typically work with expert faculty in developing content that may include test questions, case studies, monographs, and slide decks. additionally, medical writers may draft outcome reports for supporters, text to be used with infographics, or conference posters. well-established medical writers may session report moving from worst to best in medical writing for continuing education in the health professions conference http://www.amwajournal.org amwajournal.org 28moving from worst to best in medical writing for continuing education even write scripts for interactive patient case simulations or publish outcome reports in peer-reviewed journals. worst practices in writing nas though they may work from home offices spread out across the united states, freelance medical writers who develop nas for ce grants nonetheless form a tight-knit community of practice. members of this community often call themselves cme writers. from 2014 to 2019, several cme writers carried out an annual survey aimed at identifying best practices for writing nas. the survey was publicized and supported by both amwa and the alliance for continuing education in the health professions (acehp or alliance). these surveys resulted in several posters, an article jointly published in the amwa journal and the alliance almanac in 2019,3 a mini-tutorial offered to all amwa members, a presentation at the acehp national conference in 2020, and a workshop at the 2022 amwa medical writing & communication conference. within the 2018 survey, one question inquired about any poor practices that survey respondents might have observed in nas written by others. of the 104 writers responding that year, 67 reported a wide variety of poor practices. two independent reviewers, one from amwa and one from acehp, sorted these complaints into categories. the category with the greatest number of complaints was “sources and referencing,” such as outdated research, lack of proper citation, and insufficient support for gaps in education. focusing on writer-related solutions what are possible solutions to remedy these worst practices? cme writers face many challenges that may impair the quality of their work. training programs, either employer-based or university-based, are scarce. moreover, system-related problems, such as labor market supply and demand, industry expectations, or standard project lead times, may lie beyond the control of the individual medical writer. rather than trying to solve these macro-level problems, it may be more beneficial to focus on microlevel problems that lie within the control of writers, such as improving their professional knowledge, skills, and attitudes as well as learning how to deliver the types of assignments that are in high demand among cehp providers. in other words, writers can choose to focus their efforts on becoming more competent. developing a competency model although a 2-part competency model for regulatory writers has been published4,5 and a training outline for future regulatory writers has been developed,6 there is no similar model or outline for cme writers. yet, executives at med-ed companies have stated anecdotally that a competency model to address what they say is a lack of qualified cme writers would be beneficial. clinicians and former clinicians who are seeking to transition into the field have also shown a strong interest in specialized training opportunities. to meet these needs, a research project using the delphi method is currently in progress. the project has 2 primary goals: 1. identify knowledge areas, skills, and attitudes necessary for the next generation of cme writers to excel 2. identify deliverables that the next generation of cme writers should be able to develop the delphi method uses an iterative process of sending successive questionnaires to an expert panel of key stakeholders to forge consensus. in this case, the delphi panel consists of 22 experts, balanced among writers, teachers, and company executives. over a series of 3 rounds of questionnaires, the panelists are asked to rate a preliminary set of competencies and to suggest any additions. the competencies span the domains mentioned above: knowledge areas, skills, attitudes, and deliverables, or ksads. each successive round of questions contains controlled feedback in the form of ratings of the ksads as well as rationales for these ratings. panelists, whose identities are protected from disclosure during deliberations, are free to change their ratings between rounds if they are persuaded to do so after reading their fellow panelists’ rationales. a predefined group rating of 4 or higher (out of 5) indicates consensus that a given ksad should be included in the model. statistical analysis will be used to test for the stability of responses between rounds and to analyze for any differences between subgroups. helping writers move from worst to best the accme has set high ethical standards aimed at protecting the integrity of accredited instructional content for health professionals. medical writers are involved in many stages of the content development process and are uniquely positioned to add or subtract integrity. unfortunately, medical writers often come to this task unprepared because expectations are high yet adequate educational or training programs are limited. this situation leaves many medical writers with no choice but to muddle through and figure things out on their own. a competency model, developed by consensus among key stakeholders in cehp, will help the next generation of writers approach this important task http://www.amwajournal.org amwajournal.org 29moving from worst to best in medical writing for continuing education more professionally and systematically. indeed, a competency model may encourage these future writers to pursue excellence in developing high-quality, ethical, and engaging instructional content that will help clinicians, in turn, to develop the competency they need to improve patient health outcomes. jerm day-storms is the owner and principal medical writer at day-storms medical writing & research, lakeland, fl. author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. author contact: jerm@day-storms.com references 1. accme data report: onward and upward: thriving together in accredited continuing education – 2021. accreditation council for continuing medical education. published 2022. accessed december 12, 2022. https://www.accme.org/ sites/default/files/2022-10/2021%20accme%20data%20 report_967_20221005.pdf 2. standard 2: prevent commercial bias and marketing in accredited continuing education. accreditation council for continuing medical education. published 2020. accessed december 1, 2022. https://www.accme.org/accreditation-rules/standardsfor-integrity-independence-accredited-ce/standard-2-preventcommercial-bias-and-marketing-accredited-continuing 3. harting d, bowser a. worst practices for writing cme needs assessments: results from a survey of practitioners. amwa j. 2019;34(2):51-54. 4. clemow db, wagner b, marshallsay c, et al. medical writing competency model section 1: functions, tasks, and activities. ther innov regul sci. 2018;52(1):70-77. doi:10.1177/2168479017721585 5. clemow db, wagner b, marshallsay c, et al. medical writing competency model section 2: knowledge, skills, abilities, and behaviors. ther innov regul sci. 2018;52(1):78-88. doi:10.1177/2168479017723680 6. yih l, alexander ll. recommended training outline for regulatory writers. american medical writers association; 2020. accessed december 12, 2022. https://info.amwa.org/regulatorywriter-training-ebook a career in medical communication: steps to success learn about the skills and attributes needed to be a successful medical communicator and discover opportunities in the field. www.amwa.org/career_steps http://www.amwajournal.org https://www.accme.org/sites/default/files/2022-10/2021%20accme%20data%20report_967_20221005.pdf https://www.accme.org/sites/default/files/2022-10/2021%20accme%20data%20report_967_20221005.pdf https://www.accme.org/sites/default/files/2022-10/2021%20accme%20data%20report_967_20221005.pdf https://www.accme.org/accreditation-rules/standards-for-integrity-independence-accredited-ce/standard-2-prevent-commercial-bias-and-marketing-accredited-continuing https://www.accme.org/accreditation-rules/standards-for-integrity-independence-accredited-ce/standard-2-prevent-commercial-bias-and-marketing-accredited-continuing https://www.accme.org/accreditation-rules/standards-for-integrity-independence-accredited-ce/standard-2-prevent-commercial-bias-and-marketing-accredited-continuing https://info.amwa.org/regulatory-writer-training-ebook https://info.amwa.org/regulatory-writer-training-ebook v37 n4 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 25 information may be provided to a broader range of consumers. no longer will results of studies be limited to regulators and scientific/medical cognoscenti. with greater access to posted documents on a variety of portals, the public will seek and access information that is important for informed decision-making. the patient will have a stronger voice in determining their treatment, and this will extend to end-of-life decisions. social media will amplify results and will spread misinterpretations and poor-quality data. caveat emptor! are you scared or excited (or both!) by the increased use of social media to communicate scientific information? what can medical writers do to help stop the spread of misinformation? samuel entwisle: i would say both! i’m not very comfortable with social media myself, so the idea of engaging with these platforms and communicating medical information on a regular basis is a bit anxiety-inducing. but i think this can be an important role for medical writers, especially as rabbit holes of misinformation on social media can make finding accurate information difficult. i do think there is a great opportunity for collaboration between medical writers and online content creators who are savvy with how to get good social media engagement. and we should make as many plain language materials as possible free, available, and easy to discover online so that content creators can access them. i think it’s essential to build increased literacy about clinical research, and social media will have to be a big part of that. zack fey: i’m with sam on this one. regarding the surge in the sheer quantity of avenues to access scientific information, i could not be more excited. but, when it comes to social media specifically, i am more apprehensive. there is a seemingly infinite number of posts, articles, photos, and videos competing for attention on social media. and i have found myself and others skip over a scientific article in favor of something that takes less effort to read or is something more immediately captivating. it will be a challenge to create interesting and accurate scientific content that is able to compete on the mainstage of the ever-expanding universe that is social media. samuel entwisle: absolutely. if you’re trying to compete for attention on social media, the way to do that is by having big, flashy, or controversial headlines, not through nuance or data that is presented in a neutral way. this is the world we live in. but we still need ways to counteract the bad information that tends to go viral, to “develop antibodies” against it, you could say. maybe it’s rare that a piece of neutrally presented clinical trial information will explode on twitter. but maybe that’s okay! we can still make it as easy as possible for people who are actively seeking this type of information to access it, and then measure our success by making sure that people are in fact accessing it. some clinical trial sponsors are starting to think about this more seriously now, but we can definitely do better. kimbra edwards: social media plays an extremely powerful role in people's lives today. for better or worse, many turn to their social media feeds for information on a variety of topics, including scientific information. scientific information communicated through social media often uses catchy headlines and abbreviated formats, which serve as a quick and convenient way to consume information in a world where it feels mandatory to stay in-the-know and offer an opinion on a given hot topic. as my colleagues have what about the audience? theme article speakers samuel entwisle, phd / medical writer, center for information and study on clinical research participation (ciscrp), boston, ma zack fey, bs / medical writer, center for information and study on clinical research participation (ciscrp), boston, ma kimbra edwards, phd / associate director of medical writing, center for information and study on clinical research participation (ciscrp), boston, ma http://www.amwajournal.org amwajournal.org 26what about the audience? stated, a primary concern with social media is the spread of misinformation. misinformation seems to spread on social media either because important nuances aren’t captured, or someone uses the platform to speak on a topic without fully understanding it. so, what can medical writers do to help counteract misinformation? one option is to use your own social media to spread accurate scientific information, either by writing your own posts or simply sharing posts from verified sources to increase their visibility. if social media isn’t your thing, another option is to utilize the appealing aspects of social media in your work. this could include using concise language, explaining the “so what?”, and exploring alternative formats such as videos. how can medical writers enhance the quality of documents made available to the public? zack fey: as medical writers a (or dare i say, the) key skill we are always improving is our ability to communicate. communication is important in every aspect of life and especially when creating something for others to read and engage with. getting to know the audience we are writing for helps first and foremost. after that, we are tasked with putting words on paper in a way that best speaks to the target audience. it is easy to accidentally lose sight of your audience from behind your computer screen and favor your own grammar, structure, and clarity preferences. but that is the everyday challenge we happily accept. samuel entwisle: yes, getting to know our audience is so important, and it’s easier said than done. i think zack is right on that we must have a degree of humility about it and not get too married to our own opinions about what good writing looks like in other contexts. user testing can help a lot with that. and i think life experience helps as well, which is another reason why diversity in culture, race, class, gender identity, and so on is so important for good medical writing. i also really value close collaboration with editors and graphic designers. you could be writing the clearest, best sentences in the world, but if they are not formatted in a friendly way, or if they’re not accompanied by graphics that draw you in and lead you along, then i think you’ll be missing opportunities to engage with your target audience. kimbra edwards: one way for medical writers to enhance the quality of documents written for the public (or any audience, really) is to write them in plain language. utilizing plain language best practices allows you to communicate more effectively. another way, as stated above by my colleagues, is to consult with others who have expertise outside of yours. these experts might include graphic designers, editors, or patients. lastly, it is important to actually apply the learnings from these experts (for example, don’t ask patients for their feedback to simply check a box). what are some strategies medical writers can use to ensure data and information are communicated accurately but still in a way the reader can understand? how do you best balance scientific accuracy with clarity? samuel entwisle: this is always the challenge, right? i write a lot of plain language summaries of clinical trial results, and one thing i try to tell myself is there’s no such thing as perfection. it helps to approach these plain language materials with a sense of priorities. what are the most important take-home points that we need to convey? in my case, this would usually be the results of the primary endpoint of the trial, and maybe a secondary endpoint, plus some key safety data. once we now have this in mind, we can work backwards and ask what the reader needs to have a great understanding of these take-home points. if a certain concept is critical for this understanding, we can spend some time and really explain it. if not, we can give it more superficial treatment or omit it entirely. but there will always be trade-offs, and people may not always agree on how to navigate them. zack fey: i am generally a proponent of presenting something in the most concise way possible, especially in plain language documents. recently, i have been writing a lot of 2-page plain language protocol synopses for clinical trials based on the european union clinical trials regulation. when space is at a premium, i may omit the explanation of a term entirely instead of including a superficial explanation that may confuse the reader more. in the future, we may be able to offer an optional third page of the synopsis with a glossary of terms. clarity and accuracy can easily coexist under the right conditions. kimbra edwards: like sam, i find remembering the bigger picture key. what exactly do you want readers to walk away with? writing with this in mind, it becomes more obvious how best to position data and other information. when considering the balance between scientific accuracy and clarity, i also think about the balance between complete transparency and thoughtful data selection. of course, it is important not to cherry pick positive data, but it is also important to not overwhelm the reader with copious amounts of data http://www.amwajournal.org amwajournal.org 27what about the audience? that might be misinterpreted. for example, patients and the public tend to assume that all adverse events are caused by the study treatment, even when it is clearly explained that this is not the case. this can give the impression that the study treatment is less safe than it is. thus, writers of plain language summaries of clinical trials should consider only including possibly related adverse events above a thoughtfully determined frequency threshold. what are some ethical concerns when writing for patients and the public? how can we as writers best mitigate these concerns? zack fey: one of the biggest ethical concerns is the source of funding and information. medical writers must accurately, fully, and nonpromotionally convey scientific information to patients and the public while still meeting the sponsor’s requests and needs for a given project. often, the needs of the public and a sponsor can seem at complete odds with one another. with a title like “medical writer,” someone may think all we do is sit at a keyboard and type about science. what i’ve learned is that while writing is a large part of the job, learning to successfully compromise on complex topics to provide useful documents is more the task at hand. a medical writer must take seriously the duty of being one of the checks and balances to all scientific information that reaches the public. samuel entwisle: compromise is an important skill for medical writers, especially those balancing the interests of trial sponsors and patients. one thing that can help a great deal is defining detailed processes and templates that the writer and the clinical trial sponsors agree to. this can prevent some difficult situations when deciding, for example, which endpoints or safety data to include in a plain language summary, or whether to refer to a drug by its trade name. mutually agreed-upon processes and templates can help to keep plain language deliverables nonpromotional. ultimately, increased literacy about health and clinical research is in everyone’s interest. kimbra edwards: much of the “friendly friction” we encounter with sponsors arises from disagreements on data inclusion and the overall messaging of the results because we strive to present results in a nonpromotional, neutral way. luckily, we work with collaborative sponsors that respect the ciscrp’s independent positioning and patient-centered approach, so typically this friction is resolved after a brief explanation of why we do things the way we do them. it is important that other medical writers working with sponsors (or other stakeholders with varied interests) feel comfortable enough to uphold the high ethical standards that come with writing for patients and the public. what are the benefits and challenges of user-testing documents with the intended audience (public, patients, health care providers, etc.)? samuel entwisle: i think the benefits of user testing are clear. in general, getting feedback from your intended audience is essential for a writer. it is crucial to get input from all stakeholders, especially patients and the public, regarding how information about medicine and clinical research is communicated. we are lucky enough to work at an organization in which almost every deliverable we create is user tested by a review panel of patients, patient advocates, and members of the public. this gives us confidence that we are creating high-quality deliverables, and it has also led us to accumulate a great body of knowledge and the best practices about how to best communicate about clinical trials in a clear and humane way. one challenge, i think, is that we want to avoid over-correcting. for example, if one person makes a comment that they don’t like how a certain concept is explained, but 9 people like it best the way it is but say nothing, we want to make sure we don’t fix what isn’t broken. zack fey: a challenge i see with user testing is that the public, patients, and health care providers can provide feedback that is too general. a comment such as “this is good,” for example, isn’t very helpful. like sam said, user testing is great to build the “confidence that we are creating high-quality deliverables,” but the best feedback takes time and active engagement from the reviewers. finding reviewers that are willing to give up their time to provide quality feedback that will translate into an improved deliverable is no easy task. kimbra edwards: another challenge with user-testing documents with their intended audience is the extra time it takes. there is no doubt that the feedback obtained by user testing can be valuable, but with strict deadlines, it can be a real challenge to fit meaningful user testing into a project timeline. one strategy is to start your project as early as possible. plain language trial results summaries can have strict posting deadlines. to meet these deadlines and still have time for user testing, we have started drafting the summaries based on the tables, figures, listings document instead of the clinical study report, which can often take much http://www.amwajournal.org amwajournal.org 28what about the audience? longer for sponsors to finalize. if you can’t start your project any earlier, another strategy is to start recruitment for the user testing far in advance. having your reviewers in place and ready to go, with clear deadlines and expectations communicated, is very helpful. author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. author contact: kedwards@ciscrp.org biosummaries kimbra edwards is the associate director of medical writing at the center for information and study on clinical research participation (ciscrp). ciscrp is a nonprofit organization focused on increasing awareness and understanding of clinical research participation. edwards helps oversee the creation of easy-to-understand trial resources for patients, participants, and the public. this work utilizes a patientand community-centric approach to build accessible and engaging content. edwards earned her bs in neuroscience from trinity college and her phd in developmental and brain sciences from university of massachusetts boston. samuel entwisle is a medical writer at the ciscrp. entwisle helps to create plain language trial results summaries and plain language summaries of publications among other lay-language resources. entwisle earned his bs in biochemistry from the university of maine and his phd in molecular and cellular biology from the university of washington. zack fey is a medical writer at the ciscrp. fey helps create easy-to-understand trial resources, including plain language protocol synopses and plain language trial results summaries. fey earned his bs in economics from george washington university and did a postbaccalaureate premedical program at tufts university. www.amwa.org/knowledge_builders knowledge builders build your knowledge on a specific medical communication topic through a variety of elements designed to create an engaging educational experience. listen to a narrated slide set engage in exercises access the handout review the reading list note what you learned explore amwa online learning and get ready to l.e.a.r.n. http://www.amwajournal.org v38 n1 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 30 speaker j. kelly byram, ms, mba, els founder and ceo, duke city consulting, llc, albuquerque, nm by noelle ochotny, phd artificial intelligence (ai) projects are becoming more common assignments for medical communicators. in fact, a show of hands in this session revealed that approximately one-third of us have worked on a project involving ai and, among those who had not, many anticipated they would in the coming year. the presentation was organized into 3 sections. the first discusses the basics of ai and machine learning (ml) technology. the second describes how ai tools are developed and implemented. the third identifies and provides examples of the current and emerging applications of ai in clinical research and health care. the session’s focus is on narrow ai, specifically, on a type of ml called supervised learning. it is important to note that not all the ai health applications discussed in this session are implemented in health care yet. what are some challenges associated with ai? ml model creation requires data and computing resources. creating the complexity required for a valid ml model can require extensive resources. there are also issues with trust in the ability of the model to make correct decisions that are for the benefit of the patient. therefore, data and privacy security need to be robust. having strong data and privacy security can help build trust in the ml model. catalysts for the development of ml recent developments have catalyzed the development of ml models and include • big data, which provides the necessary data and resources. • cloud storage, which enables organizations to store, access, and maintain large amounts of data required for ml model development. also consider that the volume of medical data doubles every 8 to 12 months, which requires a lot of storage. • powerful computing is essential. ml can be a computationally intensive process, so a powerful computer is needed to handle the load. • parallel processing, which allows the ml model to be deployed across multiple processors. this is necessary for the ml algorithm to perform large amounts of computation on large data sets, especially in the deep learning context. • maturation of statistics and mathematical methods, which underlie ml. session report the use of artificial intelligence and machine learning in clinical research and health care conference artificial intelligence and machine learning terms artificial intelligence (ai): leverages computers and machines to simulate the problem-solving and decision-making capabilities of the human mind. weak ai, also called narrow ai: this type of ai is limited to a specific task or narrow area. strong ai: an ai that has mental capacities and flexible intelligence that mimic the human brain. this type of ai is also sometimes referred to as artificial general intelligence, artificial consciousness, or sentience. machine learning (ml): an ai technique that teaches computers to learn from data. algorithm: a set of instructions. in ml, the algorithm learns and evolves without human intervention based on the data it processes. the algorithm builds on commonly used models such as linear regression, logistic regression, bayesian algorithms, and decision trees. the terms algorithm, model, and tool are sometimes used interchangeably. deep learning: a type of ml that uses an artificial neural network (ann). anns are layers of connected nodes designed to emulate human processing of information. http://www.amwajournal.org amwajournal.org 31the use of ai and ml in clinical research and health care types of ml there are 3 common types of ml models, supervised, unsupervised, and reinforcement learning. supervised learning uses labeled training data that pairs inputs with outputs (input-output pairs are called examples; a collection of examples is a data set). an application of this type of learning might be an application that predicts if a specific type of tumor is likely to be malignant or benign based on its size, for example. algorithm training, validation, and testing require a data set be subdivided into a training data set, a validation data set, and a testing data set. supervised learning occurs via a training loop (figure). in supervised learning, the percentage of the data set dedicated to each function depends on biostatistical calculations that will inform this decision. this can be similar to the sample size calculations used to determine the sample size in clinical trials. it is important that the data sets are representative of the population so that the resulting ml model is generalizable. unsupervised learning uses unlabeled training data— rather, the computer looks for patterns in the data. some examples of this type of learning are images and pathology data. used for clustering, segmentation is an example of how this type of learning can be applied. reinforcement learning is a reward-and-penalty type of learning beyond the scope of this session. deep learning has more complicated models composed of nodes organized in layers. each layer transforms information and passes it to another layer. the term “deep” refers to the number of layers through which the model operates. in this type of learning, the model can learn from itself to create new features. ground truth information is fed back into the model to enable the deep learning model to learn from itself. (ground truthing is a term used in ml that means checking the results of machine learning for accuracy against the real world.) an example of deep learning is facial recognition. deep learning requires a vast number of resources. what are some ml models being developed in health care and clinical research? 1. risk assessment and prevention. the patient completes a questionnaire that includes a personal and family history, and the algorithm can calculate the patient’s risk for cancer. to do this, the algorithm uses guidelines such as the national comprehensive cancer network guidelines to determine a patient’s risk for certain cancers. the algorithm then goes on to suggest risk reduction strategies and treatment plans for that patient. is there a role for medical writers? consider that there are patient-facing and clinician-facing aspects related to the model. medical communicators may develop information regarding risk reduction, testing, and treatment options that is provided to those audiences. the medical writer can communicate what is going into the model and what is coming out of the model using language specific to the 2 audiences: clinicians and patients. in addition, trust in the model is an ongoing issue. the medical writer plays an important role to develop trust. attendees were interested in whether there are guidelines in place on how to communicate the risk assessment and prevention tools to patients in order to obtain informed consent. these tools collect sensitive data from patients and their families, so the patient and the family need to provide informed consent. the attendees were also interested in whether medical students and residents are receiving training on ai and ml. one attendee reported that their institution, the university of florida, launched a curriculum on ai development for physicians and clinicians. ai and ml models may affect how medical students and residents receive training. for example, a radiologist has seen thousands of images, and current medical students may not get that experience. 2. clinical decision support software. there is an ongoing debate about which software is regulated as a device. the united states food and drug administration (fda) issued a guidance1 regarding clinical decision support software to describe the fda’s regulatory approach to clinical decision figure. supervised learning training loop. copyright 2022 duke city consulting, llc. http://www.amwajournal.org amwajournal.org 32the use of ai and ml in clinical research and health care support software functions. consult the guidance for a complete discussion and examples. keep in mind that if the software contains ml, then the fda considers it to be a device. the fda consistently updates guidelines for ai/ml applications. 3. diagnosing retinal disease. this is a fast-growing market that includes diabetic retinopathy, a common complication of diabetes. to diagnose retinal disease, a camera takes an image of the patient’s retina that is then analyzed using ml. several papers reported an ai detection rate of retinal disease that is better than the detection rate of clinicians. however, the ai performed worse at diagnosing negative cases.2,3 4. reading and segmenting medical images. several ml tools are being used in the radiology field. radiologists who used ml to read medical images worked 65% faster.4 it is important to note that the use of ml tools improves workflow but does not replace the radiologist.4 many of the ml tools listed on the fda website as being approved are developed for radiology. 5. predictive modeling. these models help predict outcomes like who will require readmission to the hospital within 30 days of discharge, among others. predictive modeling can be added to a hospital’s electronic health record package. the process to add predictive modeling to an electronic health record package is straightforward because there are vendors who can add the models. for example, the tracking of fall risk, heart failure, and early detection of sepsis can be electronic health record add-ons. however, it is vital that these add-ons meet guidelines requiring model reporting, be useful, fair, and reliable, and are generalizable and transparent. a lack of transparency in an ai model can pose a significant barrier to gaining the trust of patients and clinicians. 6. drug discovery and development. deepmind’s alphafold 2 can predict how a protein folds with an accuracy rate similar to crystallography, but in hours rather than months.5 alphafold 2 radically shortens the identification and development cycles for new drugs, a great boon to biomedical researchers. 7. nanotechnology. there is hope that this emerging technology field can be applied to cancer diagnostics and cancer therapeutics; however, intratumor and interpatient heterogeneity have posed significant barriers in this area. application of ai methods to the design and analysis of outcomes have met with some success. what is generative ai? generative ai is a type of ml algorithm that is designed to generate new data based on what it has learned from the data that it has been trained on. this can be used to create new images, text, or other forms of data that mimic the characteristics of the training data. for example, ai can create images of people that look real but who do not exist.6 what are funders and the fda looking for? the main concerns of funders and the fda are found in the good machine learning practice for medical device development: guiding principles document.7 the concerns that some application developers tend to neglect, in byram’s experience, are included in the following list. of particular focus is improving the performance of the human-ai team. another concern is that models degrade over time and need to be retrained. key takeaways from this guideline include 1. the multidisciplinary team should work together throughout the total product life cycle to ensure that the ai remains relevant. 2. make sure that clinical study participants and data sets are representative of the population, so the models developed on them are generalizable. 3. be sure to emphasize the performance of the human‐ai team. 4. ensure that deployed models have the capacity to be monitored with a focus on improved safety and performance, and appropriate controls are in place to manage retraining risks. attendees were curious about the intersection of privacy laws and training data sets. attendees indicated that, in their experience at their institutions, the patient provides consent for their data to be used in data training sets. to build and maintain trust with the patient, the consent form should include a statement that all patient data will be kept secure, and the data used for ml is deidentified using protected health information guidelines. closing byram closed the presentation by emphasizing the importance of being aware of the fda and funder guidelines and to consult the references provided in the presentation for further guidance. http://www.amwajournal.org amwajournal.org 33the use of ai and ml in clinical research and health care noelle ochotny is a medical writer at foremost medical communications in mississauga, ontario, canada. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: nochotny@fmc.cc references 1. us food and drug administration. clinical decision support software: guidance for industry and food and drug administration staff. us food and drug administration, 2022. accessed december 20, 2022. https://www.fda.gov/ media/109618/download#:~:text=the%20food%20and%20 drug%20administration%20%28fda%29%20has%20 long,therefore%20subject%20to%20fda%20oversight%20as%20 a%20device 2. gulshan v, peng l, coram m, et al. development and validation of a deep learning algorithm for detection of diabetic retinopathy in retinal fundus photographs. jama. 2016;316(22):2402-2410. 3. raumviboonsuk p, krause j, chotcomwongse p, et al. deep learning versus human graders for classifying diabetic retinopathy severity in a nationwide screening program. npj digit med. 2019;2:25. 4. hosny a, bitterman ds, guthier cv, et al. clinical validation of deep learning algorithms for radiotherapy targeting of non‐small‐ cell lung cancer: an observational study. lancet digit health. 2022;4(9):3657‐3666. 5. alphafold. alphafold: a solution to a 50‐year‐old grand challenge in biology. deepmind. published november 30, 2020. accessed october 21, 2022. https://www.deepmind.com/blog/alphafold-asolution-to-a-50-year-old-grand-challenge-in-biology 6. hill k, white j. designed to deceive: do these people look real to you? the new york times. published november 21, 2020. accessed october 21, 2022. https://www.nytimes.com/ interactive/2020/11/21/science/artificial-intelligence-fakepeople-faces.html 7. good machine learning practice for medical device development: guiding principles. us food and drug administration. published october 27, 2021. accessed october 20, 2022. https://www.fda. gov/medical-devices/software-medical-device-samd/goodmachine-learning-practice-medical-device-developmentguiding-principles additional resources adir o, poley m, chen g, et al. integrating artificial intelligence and nanotechnology for precision cancer medicine. adv mater. 2020;32(13):e1901989. artificial intelligence and machine learning in software as a medical device. us food and drug administration. published september 22, 2021. accessed october 20, 2022. https://www.fda.gov/medical-devices/software-medicaldevice-samd/artificial-intelligence-and-machine-learningsoftware-medical-device jaber n. can artificial intelligence help see cancer in new, and better, ways? national cancer institute. published march 22, 2022. accessed october 20, 2022. https://www. cancer.gov/news-events/cancer-currents-blog/2022/ artificial-intelligence-cancer-imaging iwano t, yoshimura k, watanabe g, et al. high-performance collective biomarker from liquid biopsy for diagnosis of pancreatic cancer based on mass spectrometry and machine learning. j cancer. 2021;12(24):7477-7487. jumper j, evans r, pritzel a, et al. highly accurate protein structure prediction with alphafold. nature. 2021;596(7873):583-589. kann bh, hosny a, aerts hjwl. artificial intelligence for clinical oncology. cancer cell. 2021;39(7):916-927. lu jh, callahan a, patel bs, et al. assessment of adherence to reporting guidelines by commonly used prediction models from a single vendor: a systematic review. jama netw open. 2022;5(8):e2227779. roose k. a coming-out party for generative a.i., silicon valley’s new craze. the new york times. published october 21, 2022. accessed october 21, 2022. https://www.nytimes. com/2022/10/21/technology/generative-ai.html stable diffusion 2.1 demo. hugging face. accessed october 21, 2022. https://huggingface.co/spaces/stabilityai/stablediffusion tran ka, kondrashova o, bradley a, williams ed, pearson jv, waddell n. deep learning in cancer diagnosis, prognosis and treatment selection. genome med. 2021;13(1):152. http://www.amwajournal.org https://www.fda.gov/media/109618/download#:~:text=the%20food%20and%20drug%20administration%20%28fda%29%20has%20long,therefore%20subject%20to%20fda%20oversight%20as%20a%20device https://www.fda.gov/media/109618/download#:~:text=the%20food%20and%20drug%20administration%20%28fda%29%20has%20long,therefore%20subject%20to%20fda%20oversight%20as%20a%20device https://www.fda.gov/media/109618/download#:~:text=the%20food%20and%20drug%20administration%20%28fda%29%20has%20long,therefore%20subject%20to%20fda%20oversight%20as%20a%20device https://www.fda.gov/media/109618/download#:~:text=the%20food%20and%20drug%20administration%20%28fda%29%20has%20long,therefore%20subject%20to%20fda%20oversight%20as%20a%20device https://www.fda.gov/media/109618/download#:~:text=the%20food%20and%20drug%20administration%20%28fda%29%20has%20long,therefore%20subject%20to%20fda%20oversight%20as%20a%20device https://www.deepmind.com/blog/alphafold-a-solution-to-a-50-year-old-grand-challenge-in-biology https://www.deepmind.com/blog/alphafold-a-solution-to-a-50-year-old-grand-challenge-in-biology https://www.deepmind.com/blog/alphafold-a-solution-to-a-50-year-old-grand-challenge-in-biology https://www.nytimes.com/interactive/2020/11/21/science/artificial-intelligence-fake-people-faces.html https://www.nytimes.com/interactive/2020/11/21/science/artificial-intelligence-fake-people-faces.html https://www.nytimes.com/interactive/2020/11/21/science/artificial-intelligence-fake-people-faces.html https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device https://www.cancer.gov/news-events/cancer-currents-blog/2022/artificial-intelligence-cancer-imaging https://www.cancer.gov/news-events/cancer-currents-blog/2022/artificial-intelligence-cancer-imaging https://www.nytimes.com/2022/10/21/technology/generative-ai.html https://www.nytimes.com/2022/10/21/technology/generative-ai.html https://huggingface.co/spaces/stabilityai/stable-diffusion https://huggingface.co/spaces/stabilityai/stable-diffusion american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. v37 n3 / 2022 ©2022 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 51 australasian medical writers association “honoring the past, embracing the future” september 22-24, 2022 sydney, australia https://www.medicalwriters.org/events/amwaconference-2022-sydney/ national association of science writers “science writers 2022” october 21-25, 2022 memphis, tennessee https://www.nasw.org/events/sciencewriters-2022memphis international society of managing and technical editors “scholarly publishing in a connected world: turning disruptions into opportunities” november 1-3, 2022 virtual https://www.ismte.org/events/eventdetails. aspx?id=1630533&group= american medical writers association “amwa 2022 medical writing & communication conference” november 2-5, 2022 denver, colorado https://www.amwa.org/page/conference european medical writers association “the 54th emwa conference” november 3-5, 2022 riga, latvia https://www.emwa.org/conferences/future-conferences/ american public health association “apha 2022 annual meeting & expo” november 6-9, 2022 boston, massachusetts https://www.apha.org/events-and-meetings/annual alliance for continuing education in the health professions “2023 alliance annual conference” february 6-9, 2023 national harbor, maryland https://www.acehp.org/your-learning/events american association for the advancement of science “science for humanity” march 2-5 2023 virtual or washington, dc https://meetings.aaas.org/ dia europe “dia europe 2023” march 22-24, 2023 basel, switzerland https://www.diaglobal.org/flagship/dia-europe-2023 calendar of meetings http://www.amwajournal.org https://www.amwa.org/resource/resmgr/conference/2022/2022_amwa_conf_regprogram_pr.pdf https://www.amwa.org/events/eventdetails.aspx?id=1632249 https://www.ismte.org/events/eventdetails.aspx?id=1630533&group= v38 n4 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 34 the amwa board of directors (bod) issued a statement in june 2020 acknowledging that health and well-being for all cannot exist alongside endemic racial health inequities. the statement emphasized that diversity is a strength that enriches amwa membership. in 2021, the bod confirmed the goal of creating a more inclusive, diverse, and collaborative environment for members and set a direction for enhancing diversity and inclusion efforts within the organization. in addition to the updated amwa diversity, equity, and inclusion (dei) statement,1 the bod appointed a diversity and inclusion (d&i) assessment task force. the task force was charged with analyzing membership data and gathering member input to help determine the current status of the organization’s d&i; identify deficiencies, needs, opportunities, and challenges related to d&i; and recommend initial strategies to enhance d&i within the organization. the task force developed the 2022 amwa dei survey with the goals of gaining a clearer understanding of the existing diversity of membership, identifying current shortcomings, and recognizing how to build upon amwa’s current strengths to enhance the overall atmosphere of d&i within amwa. this survey allowed the task force to assess the demographics of our members. asking the right questions and offering members the chance to holistically share information about their identities provides amwa with the opportunity to better serve their members and learn key areas for improvement. the survey was sent to 4,649 amwa members, of whom 397 responded. the demographic data presented here identify some clear opportunities for growth, particularly as relates to better serving members who are disabled and members who may belong to marginalized groups. in march 2023, the task force reported to bod with survey results and recommendations. the scope of this article is to summarize the information on amwa membership gathered as results of the survey. responses to open-ended questions and decisions to be made on the basis of the survey responses are not included in this article and will be addressed in future communications. membership status to ensure that the survey captured an accurate picture of current amwa membership, respondents were asked to provide their membership status. of survey respondents who answered this question (n = 396), 98% (n = 388), reported that they were current members of amwa at the time of the survey. age we received 395 responses to the question about age. amwa membership is primarily aged 40 to 59, with 28% of members identifying as aged 40 to 49 (n = 112) and 28% of members identifying as aged 50 to 59 (n = 109). twenty percent of members were aged 60 to 69 (n = 78), 16% aged 30 to 39 (64), and 2% aged 25 to 29, with 4% either younger than 30 or over 80. veteran/military status of the 388 respondents to this question, 99% did not identify as a veteran or member of the us military service. educational background one hundred eighty-five members (47%) hold a doctoral degree, whereas 34% of members (n = 133) hold a master’s degree. nineteen percent of members (n = 74) have attained an undergraduate degree. employment role, area of focus, and experience to characterize the work roles of amwa members, 54% (n = 215) identified themselves as employees of companies, whereas 37% (n = 148) are freelance workers. five percent are looking to enter the field, and 4% do not actively work in the field or are retired. the largest group of members worked for pharmaceutical or biotechnology companies (22%, n = 86), with 20% working in medical communication as a close second. eleven percent work for a research or academic institute, 9% work for a clinical or contract research organization, and 7% work for a medical research education results of the 2022 amwa dei survey karla haack, phd1; toni willis, mfa2; and jeanette towles, ma, rac-drugs3 / 1merck & co, rahway, nj; 2rti health solutions, research triangle park, nc; 3synterex, inc, dedham, ma topical feature http://www.amwajournal.org https://www.amwa.org/page/position_statement https://www.amwa.org/page/position_statement amwajournal.org 35results of the 2022 amwa dei survey company. six percent of respondents work for a health care organization or provider, and 6% of respondents work for a nonprofit organization or professional society. five percent of respondents work for a medical device company, and the remaining 3% work for a publisher or journal office (2%) or a government agency or contractor (1%). the remaining 11% of respondents (n = 42) work for a different type of organization or client. amwa respondents’ primary work interests or focus areas were primarily regulatory writing and editing (32%; n = 127) and scientific publications (26%; n = 102). however, 10% of respondents (n = 39) listed their primary work interest/area of focus as health communication/public health/ journalism/patient education. fewer than 10% of respondents selected selected each of continuing education, publications for professional audiences, promotional writing/ marketing/advertising/public relations, medical affairs, grant proposals, and sales training as their primary work interest or focus area, and 6% of respondents selected that their primary work interest or focus area is another type of medical writing or editing. survey respondents varied in experience, but 46% (n = 193) of respondents have worked in the field from 11 to 30 years, with 23% (n = 91) working in the field from 11 to 20 years and 23% (n = 92) working in the field from 21 to 30 years. however, the percentages that do not fall into this group are still sizable, with 17% (n = 68) who have worked in the field for 0 to 2 years, 14% (n = 54) for 3 to 5 years, and 13% (n = 52) for 6 to 10 years. finally, 10% (n = 40) of respondents have worked in the field for more than 31 years (figure 1). residency by far the largest group (91%; n = 360) of respondents who answered this question lived within the united states. the state with the highest number of respondents was pennsylvania (9%; n = 33), with california and north carolina also at 9% with 30 respondents each. massachusetts and texas each had 7% of respondents, or 24 respondents each. new jersey, illinois, and maryland each had 5% (with 18, 17, and 16 respondents, respectively), and 4% of respondents lived in each of colorado (n = 15), new york (n = 15), and florida (n = 13). for respondents who lived outside the united states, the most common country of residence was canada, with 50% (n = 17) of respondents. remaining numbers of respondents are too low to disclose without potentially identifying members. disability, chronic illness, and neurodiversity of 395 survey respondents, 17% indicated that they had a disability; the most common disabilities were chronic illness (43%), mental health condition (24%), and other (12%; details were provided on the survey but are not included to preserve the privacy and identities of the respondents) (figure 2). among 42 respondents who declared a disability and did not experience barriers to participation in amwa, methods of accessing amwa services included online (64%) (“internet,” “computer,” and “virtually”), other (14%), online or other electronic medium with in-person attendance (ie, hybrid) (12%), with help of accommodation or regulation within their own limits (7%), with help of assistive device (5%), and via mailing list (2%). of note, given that some respondents who answered no to having a disability responded to this question (n = 11), there appear to be amwa members interested in both online and hybrid formats in general and who would benefit from accessibility accommodations even though they may not consider themselves disabled. several respondents mentioned in their response restrictions/barriers to access, including expense (n = 2) or other barrier (n = 1). several (n = 5) respondents also indicated that although they attend virtually when they can, they wish that there were more virtual options for participation, celebrated the greater number of virtual options available in recent years, or noted limited options for virtual figure 1. question 14: years of experience as a medical writer and/or editor. total respondents = 397. 0 to 2 3 to 5 6 to 10 11 to 20 21 to 30 31 or more 0 10 20 30 percent responses ye ar s of e xp er ie nc e 17 14 13 23 23 10 figure 2. question 7: do you have a disability? total respondents = 395. yes 17% no 83% http://www.amwajournal.org amwajournal.org 36results of the 2022 amwa dei survey participation. twenty-three participants who answered that they had a disability did not answer the question on how they access amwa services. among 17 respondents who declared a disability and noted that they require accessibility accommodations for virtual conferences, online learning, webinars, or virtual networking, accommodations included having available virtual/online learning opportunities in general (35%); technological options enabled for closed caption, chat, and/ or ability to control speed of or repeat audio (29%); other (24%); and copies of large-font materials and advance availability of materials (6% each). similar to the above, some respondents who answered no to having a disability responded to this question (n = 5), with an additional accommodation for diet-related concerns, so there appear to be amwa members interested in having these types of accommodations available even though they do not consider themselves disabled. multiple respondents noted a need for accommodations beyond technology and physical space (eg, scent-free spaces, noise reduction). among the 397 survey respondents, 5% indicated they were neurodivergent, with 13% indicating they were not sure if they are neurodivergent and no response for 3% (figure 3). most of the respondents who scored amwa as 1 or 2 with respect to accessibility and belonging were disabled. among respondents who gave low (1 or 2 out of 5; the scale ranged from 0 [poor] to 5 [excellent]) scores to “rate how well amwa is currently doing on” belonging, diversity, equity, and inclusion, most respondents who rated amwa’s performance on “belonging” as 1 or 2 (n = 17) identified as having a disability, and half of respondents who rated amwa’s performance on “diversity,” “equity,” or “inclusion” as 1 or 2 (n = 29, 20, and 22, respectively) identified as having a disability. race and ethnicity over 80% of the survey respondents were white (n = 326), with 9% identifying as asian american, southeast asian, east asian, or of asian descent. members who identified as black, african american, or of african descent were 5% of respondents, and 4% of respondents identified as multiracial or mixed race, with many identifying as 2 or more races. six percent of respondents self-identified as latine/latina/ latino/latinx or hispanic. additional remaining percentages were too low to disclose. it will be important in future analyses to evaluate associations between self-identified race and ethnicity and answers to survey questions regarding belonging, inclusion, accessibility, equity, and diversity. sexual orientation and gender identity we examined answers to the pronoun, gender identity, and sexual and romantic identity questions. of 79 respondents to the question about the individual use of personal pronouns, 53 respondents indicated that they use “she/ her,” 52 indicated that they use “he/him,” and 8 indicated that they use “they/them.” additionally, 15 of 79 respondents selected “i do not use personal pronouns.” there were some challenges evaluating this section of the survey. some lgbtqia+ people do not identify with any personal pronouns. however, many of the respondents who selected this last option seem, based on their answers to other questions on the survey, to have done so either because they did not understand what personal pronouns are or because they were using the option to protest the inclusion of multiple gender identities. when asked about sexual and/or romantic orientation, 19% (75 of 397 respondents) represented diverse sexual or romantic orientations and 82% (n = 324) identified as heterosexual or straight. see table 1 for the sexual or romantic orientations included.no 81% not sure 14% yes 5% figure 3. question 9: are you neurodivergent? total respondents = 385. answer choices responses (%) heterosexual 225 (58) straight 118 (31) bisexual 19 (5) queer 16 (4) lesbian 14 (4) gay 11 (3) a sexual or romantic orientation not listed here. please specify: 11 (3) demisexual 9 (2) asexual 5 (1) questioning 4 (1) demiromantic 3 (1) panromantic 3 (1) pansexual 3 (1) aromantic 1 (0) biromantic 0 (0) total respondents 385 table 1. question 5. sexual and/or romantic orientation or self-identify. check all that apply. http://www.amwajournal.org amwajournal.org 37results of the 2022 amwa dei survey regarding gender identity, 12% (n = 49) of respondents are transgender or gender diverse. all other respondents (88%; n = 348) identified as cisgender (or identifying with the sex they were assigned at birth). additional information provided in the open response questions indicates the following opportunities for amwa: additional work needs to be done to (1) refine the language used in these questions, (2) address safety and inclusion for these members, and (3) provide platforms for educating members on inclusive language. additional analyses of open response questions related to amwa’s culture of inclusion around sexual orientation and gender identity will be provided in a follow-up article. dei and amwa survey respondents were asked to rank 8 strategies they felt would be most helpful for amwa as it works toward cultivating a more inclusive culture. the 3 top-ranked strategies were having diverse representation in amwa authors, speakers, and presenters; having diverse representation in leadership/ governance; and providing programs and resources on dei topics. respondents were also asked to identify topics for potential resources relating to dei that would be most helpful to them as medical communicators. the top 3 responses were resources on using inclusive language in medical communication, how to develop inclusive health communications, and health equity and health disparities. the task force is grateful to everyone who participated in the survey. we hope that this information will enable amwa to learn how to enhance the overall atmosphere of d&i within amwa. amwa diversity and inclusion (d&i) assessment task force members • emmanuel bassey, md, msc, vision loss in later life research lab (vital), university of western ontario • demetrius carter, mba, senior vice president, regulatory services, certara synchrogenix • dean colston, phd, ma, director of social media and health communications, a flock of scientists, llc • gail flores, phd, principal writer, encore biomedical communications llc • karla haack, phd, medical writer, merck & co • cyndy kryder, ms, mwc, medical communications consultant • endia santee crabtree, phd, ms, mla, senior clinical product risk scientist, boston scientific • jeanette towles, ma, president and owner, synterex, inc • shawn watson, pharmd, phd, bcps, senior director, clinical development and program team lead, bicycle therapeutics • vee white, ba, owner/senior medical editor, vee white editorial • toni willis, mfa, medical editor, rti health solutions ex-officio members • katrina burton, program manager, public relations, the university of texas md anderson cancer center, amwa 2021-2022 president • susan krug, cae, ms, executive director, amwa • sharon ruckdeschel, staff liaison author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. author contact: karla.haack@merck.com, twillis@rti.org reference 1. krug s. the american medical writers association (amwa) announces new diversity, equity, and inclusion statement. amwa j. 2022;37(3):32. doi:10.55752/amwa.2022.189 http://www.amwajournal.org v38 n3 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 3 theme article medical communicators are tasked with delivering scientific information to numerous stakeholders, including patients, caregivers, providers, researchers, policymakers, and payors, around the world. in recent years, content offerings have expanded beyond traditional scientific publications deliverables, such as abstracts and articles, to include enhancements that are more easily digestible by patients or busy clinicians, such as plain language summaries, infographics, graphical abstracts, and other multimedia formats. global medical communications is a burgeoning field that involves the delivery of cutting-edge scientific research to a broader global audience. however, medical and scientific articles have historically been published only in english and kept behind journal paywalls, limiting accessibility by the global scientific community. in this special issue of the amwa journal, we explore some of these issues and consider ways that medical communicators are improving access to scientific data and bridging the gaps between stakeholders around the world. in the first theme article of this issue, amanda xiaoqing mao, phd, an experienced bilingual chinese medical communicator and translator, shares best practices for medical translators to ensure the best possible translations. to begin with, medical translators must possess strong writing skills and have a thorough understanding of medical terminology in both the source and target languages to ensure that a translation accurately conveys the intended message while maintaining the original tone and style. to support their work, medical translators may use existing tools or create their own when needed, such as bilingual glossaries or machine translators. in conclusion, dr mao posits that medical translation is an essential component of the global medical communications industry, alongside regulatory writing, scientific publications, health communication, continuing medical education, promotional writing, and grant writing. in the second theme article of the issue, jo gordon of oxford pharmagenesis shares information about the history and mission of open pharma, which is a nonprofit-seeking collaboration that aims to improve the communication of research sponsored by the pharmaceutical industry. the article offers a wealth of information to medical communicators working in the field of scientific publications about the work and resources of open pharma and how they can get involved. in the third theme article of this issue, claire beeby and eleanor j. raynsford of oxford pharmagenesis and charles pollitt of ipsen present findings of a pilot study that evaluated a web-based translation tool for translating scientific abstracts and plain language summaries (plss). google translate was used to translate abstracts and plss from 5 medical journal publications into 4 languages: french, german, mandarin, and slovenian. bilingual reviewers with scientific backgrounds were tasked with assessing the translation quality of each abstract and pls. the authors present the results of their study along with a discussion of their research in context and ways to increase accessibility of scientific content by non-english speakers. i would like to note that the articles in this issue have been graciously contributed by medical communicators working outside the united states in europe, asia, and australia, thus providing a different perspective on issues that may be important to medical communicators around the world. i invite both our current amwa members as well as any new readers of our journal from around the world to share feedback about the content and consider contributing their own perspectives on global medical communications to future issues of the amwa journal. author declaration and disclosures: the author notes no commercial conflict of interest in relation to this article. the views and opinions expressed in this article are those of the author and do not necessarily reflect the views of the author’s employer. author contact: lizkukielka@gmail.com elizabeth kukielka, pharmd, mwc, cmpp / oxford pharmagenesis, inc, newtown, pa overcoming obstacles and building bridges in global medical communication from the guest editor http://www.amwajournal.org contents v38 n1 spring 2023 3 4 7 12 18 20 24 27 30 34 36 40 45 from the editor � michael g. baker conference 2022 harold swanberg distinguished service award address aspire to more: raising the bar on medical writing � julia forjanic klapproth 2022 john p. mcgovern award address global vaccines and vaccinations: science vs. antiscience � peter j. hotez 2022 walter c. alvarez award address emerging issues following covid-19: public health communication � leana wen session reports attention!: how to harness it for productivity and deep work � allie boman diy graphics for medical writers � jerm day-storms inclusive language: best practices and practical applications for medical writers and editors � rebecca moran moving from worst to best in medical writing for continuing education in the health professions � jerm day-storms the use of artificial intelligence and machine learning in clinical research and health care � noelle ochotny what is plagiarism? putting out fires around this hot topic � eloise dehaan topical features updated guidance on the reporting of race and ethnicity in medical and science journals � tracy frey common grantsmanship hurdles of early career clinician-scientists and how a medical writer can help � matthew r. sandbulte leveraging artificial intelligence, natural language processing, and natural language generation in medical writing � deepak palasamudram, karun s. karunakaran, prakhar gaur, akshatha miyal kamath, pramit saha, and tina purushotam 45 34 4 editor-in-chief michael g. baker, phd managing editor rachel mosher, ma section editors progress in publications qing zhou, phd, els regulatory insights jennifer bridgers, ms, mwc science series naomi bishop, md statistically speaking thomas m. schindler, phd everyday ethics julie ravo, ba, ma freelance focus ruwaida vakil, msc ce craft corner haifa kassis, md practical matters elizabeth kukielka, pharmd, ma, ms, mwc regular contributors freelance focus brian bass, mwc melissa l. bogen, els sherri bowen, ma, els lori de milto, mj cathryn d. evans gail v. flores, phd phyllis minick in the service of good writing laurie endicott thomas, ma, els conscious writing crystal r. herron, phd, els editors in memoriam lori l. alexander, mtpw, els, mwc ronald j. sanchez 2022–2023 president elise eller, phd 2022–2023 board liaison joanna pendergrass, dvm 2022–2023 staff liaison shari rager, ms, cae executive director susan krug, ms, cae graphic designer amy boches, biographics editorial office: managingeditor@amwa.org. instructions for authors available at: www.amwajournal.org. advertising: contact marketing@amwa.org or (240) 239-0940. all advertising is subject to acceptance by amwa and should be for products and services relevant to professional medical communicators. amwa is not responsible for the content of advertising and does not endorse any advertiser or its products or services. subscription: the amwa journal is published quarterly. subscription is included with amwa membership. nonmember subscriptions cost is $75 per year. contact: american medical writers association, 30 west gude drive, #525, rockville, md 20850-4347. phone: (240) 238-0940; fax: (301) 294-9006; email: amwa@amwa.org. the amwa journal is in the mla international bibliography and selectively indexed in the cumulative index to nursing and allied health literature (cinahl) print index and the cinahl database. the opinions expressed by authors contributing to the journal do not necessarily reflect the opinions of amwa or the institutions with which the authors are affiliated. the association accepts no responsibility for the opinions expressed by contributors to the journal. ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwa journal mission statement in support of the mission of the american medical writers association (amwa) and to advance the broader profession, the amwa journal publishes content that reflects the interests, concerns, and expertise of medical communicators. its purpose is to inform, inspire, and motivate medical communicators. m o re v38 n1 / 2023 51 freelance focus � melissa l. bogen, lori de milto, cathryn d. evans, and gail v. flores q1: in the age of linkedin, how important is a website for a freelancer? what are the key elements that should be included in developing a website? q2: what are your favorite web conferencing platforms and why? q3: what are the etiquette rules for web conferencing platforms that you follow? camera on or off and when? 54 conscious writing the intrinsic story structure of original research manuscripts � crystal r. herron 56 in the service of good writing paragraph structures � laurie endicott thomas 61 amwa news from the president � elise eller conference preview: homecoming in baltimore � michele w. sequeira 63 calendar of meetings contents http://www.amwajournal.org v38 n3 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 7 theme article abstract open pharma is a non-profit-seeking collaboration that aims to make the communication of pharma-sponsored research faster, more transparent, more accessible, and more sustainable, focusing on open science principles such as open access and plain language. open pharma includes 16 member and supporter companies representing the pharma and publishing industries and is facilitated by oxford pharmagenesis, a healthscience consultancy. we believe that innovating the current publications model for pharma research is essential to accelerate medical progress, improve patient care, and increase trust in evidence from the pharma industry. open pharma works as a think tank that seeks to “move the needle,” a research hub that produces evidence, a knowledge-sharing “club,” and a forum for member voices. our research, resources, and events are designed to educate, broaden perspectives, and foster connections. we also seek to identify needs and solutions and to develop guidance that supports best practice and positive change across the sector. medical writers are uniquely positioned to understand the benefits of open science and to communicate them to their clients. they have an important part to play in promoting the innovations that will increase the quality, transparency, and accountability of medical research communication, which open pharma supports. the origins of open pharma open pharma is a multisponsor collaboration that aims to drive positive change in the communication of pharma-sponsored research. trust in pharma industry research was, and still is, estimated to be low,1,2 despite pharma companies funding at least half of the biopharmaceutical research carried out in the united states and the united kingdom.3,4 established in 2016, open pharma was set up in recognition that improving trust in pharma research publications is a goal shared by multiple stakeholders working across the pharmaceutical, publishing, and medical communication sectors, and one only realized through collective action. oxford pharmagenesis, as an independent healthscience consultancy working across these sectors, was well-positioned to listen to and connect conversations from different stakeholder groups that share a commitment to improving the pharma publications model. thus, open pharma was launched as a member-led, non-profit-seeking project facilitated by oxford pharmagenesis. we strive to improve the pharma publications model by connecting pharma with innovations in publishing to increase transparency and broaden access to research outputs. key objectives and mission open pharma is a collaboration of forward-thinking representatives from organizations working across health care research communication. members and supporters contribute to open pharma financially at different levels. members advise and vote on the strategic direction for open pharma, and both members and supporters are involved in discussions, events, and research projects. current open pharma members include astrazeneca, boehringer ingelheim, galápagos, gilead sciences, gsk, janssen, novartis, novo nordisk, oxford pharmagenesis, pfizer, takeda, and ucb, and current supporters include bristol myers squibb, ipsen, roche, and taylor & francis. nonpaying stakeholders include advisors and followers. advisors represent policy groups, publishers, academic funders, patients, and open science innovators and take part in meetings and other activities. open pharma followers are the varied group of people who read our blog and newsletter, engage with us on twitter, linkedin, and youtube, take part in our public events, and use the information and resources available on our website. open pharma has clearly defined aims (set out in a charter) that support the goal of improving the pharma publications model. we believe that pharma company–funded research should be published in a way that is transparent, accountable, accessible, and discoverable (figure 1). operationally, open pharma works on multiple levels: as a think tank that seeks to move the needle, as a research hub jo gordon, ma, vetmb, phd / medical writer, oxford pharmagenesis, oxford, uk open pharma: driving positive change in the communication of pharma-sponsored research theme article http://www.amwajournal.org https://www.openpharma.blog/blog/ https://www.openpharma.blog/blog/ https://twitter.com/_openpharma http://www.linkedin.com/showcase/open-pharma https://www.youtube.com/channel/ucecsusxivuinjyhqn9vqltg https://www.openpharma.blog/resources/ https://www.openpharma.blog/ https://www.openpharma.blog/about-us/ https://www.openpharma.blog/wp-content/uploads/2021/02/2020-01-15-charter-of-open-pharma.pdf amwajournal.org 8open pharma: driving positive change in the communication of pharma-sponsored research that produces evidence, as a knowledge-sharing “club,” and as a forum for member voices. a varied range of activities support our road map to open science in this space (figure 2). open pharma: a think tank open access position statement open pharma promotes publishing with open access to ensure that high-quality, peer-reviewed evidence is available to anyone who needs it, anywhere in the world, without charge. publishing open access improves transparency, advances medical science, and, we believe, ultimately improves patient care (figure 3). however, access to pharma company research is often more restricted by journal paywalls than research funded by other sources. the first landmark achievement of open pharma was our open access position statement. in the statement, we highlight as an immediate priority the need to secure authors publishing company-funded research the same right to publish open access as authors publishing research funded by other sources so that all research can be made free to read from the date of publication. we also state that our long-term goal is to secure the same licensing terms for authors publishing company-funded research and authors publishing research funded by other sources, including using the most permissive creative commons license, creative commons attribution license (cc by), for all articles. as of may 4, 2023, our position statement has been endorsed >250 times by individual and institutional stakeholders – including publishers, pharma companies, patient figure 1. the aims of open pharma. pls, plain language summary. figure 2. open pharma road map to open science for pharma research communication. orcid, open researcher and contributor id; pls, plain language summary. http://www.amwajournal.org https://www.openpharma.blog/open-access-dashboard/ https://www.openpharma.blog/position-statement-on-open-access/ amwajournal.org 9open pharma: driving positive change in the communication of pharma-sponsored research figure 3. benefits of open access. adapted from kingsley d and brown s.11 cc by, creative commons attribution license. figure 4. infographic: open pharma recommendations for plain language summaries of peer-reviewed medical journal publications. adapted/ reprinted from rosenberg a et al.6,7 pls, plain language summaries. advocacy groups, and organizations engaged in open scholarship. many open pharma members and supporters have used the statement to raise awareness of open access within their companies and set open access targets, which is likely to have contributed to the rise in open access publishing observed across the sector in recent years. plain language summary recommendations plain language summaries (pls) are now an accepted way to make the content of medical research articles accessible to nonspecialist and time-challenged readers. until 2020, however, consistent guidance on how to develop pls was lacking, which limited their use. open pharma recognized this unmet need and responded by organizing a roundtable of experts and a public consultation to discuss the issue and went on to develop and publish a pls recommendations article and infographic (figure 4).5-7 with >10,000 views and 8 citations to date (as of may 25, 2023), we believe that our recommendations article is contributing to important changes in research publications, including an emerging consensus more exposure for your work practitioners can apply your findings researchers in developing countries can see your work taxpayers get value for money higher citation rates your research can influence policy compliant with grant rules the public can access your findings http://www.amwajournal.org https://www.tandfonline.com/doi/full/10.1080/03007995.2021.1971185 https://www.tandfonline.com/doi/full/10.1080/03007995.2022.2072570?src=recsys amwajournal.org 10open pharma: driving positive change in the communication of pharma-sponsored research about pls best practice among some publishers,8 adoption of mandatory policies or recommended pls practices by pharma companies,9 and an update to the good publication practice guidelines for company-sponsored biomedical research advising publication of pls for all clinical research articles.10 open pharma: a research hub educational material open pharma has developed a bank of resources that are freely available on our website for anyone to use. this material can help medical writers, pharma companies, and publishers to become more aware of open science and implement open science practices in their day-to-day work. resources include a crib sheet for developing plain language documents, a toolkit for adopting open researcher and contributor ids (orcid) in publications, and educational slides about open access. research projects open pharma research poster presentations are also freely available on our resources page. these posters summarize various analyses of open access for pharma company-supported articles, use of orcids in pharma-affiliated publications, and discoverability of pls. here, we highlight 3 examples of recent or ongoing open pharma research. discoverability of pls. concise text-based pls can assist a nonexpert and time-constrained audience to find and use published research. pubmed is one of the most widely used platforms for accessing biomedical research and, since 2019, text-based pls hosted on this platform can be discovered when tagged (electronically labeled) with a plsspecific label, the <plain-language-summary> metatag.12 to assess how pls are being indexed (labeled and organized) on pubmed, open pharma carried out an automated search of the presence and use of the pls metatag. our results uncovered an unmet need for explicit guidance on both the processes of indexing and the correct use of the <plain-language-summary> tag, which could help improve uptake and correct tagging.13 the findings show an opportunity for everyone, including medical writers, to increase the impact of their content and reach a broader audience by ensuring article pls are tagged appropriately on pubmed. a version of the conference poster presentation is available on youtube. open access benchmarking. open access publications are more likely to be discovered and accessed by a broad audience.14 since open pharma’s launch and the publication of our position statement, the open access landscape has changed. several major public research funders have implemented mandates requiring that their grant recipients publish their findings with immediate open access (eg, uk research and innovation, 2021; national institutes of health, 2023). in the private sector, pharma companies takeda (formerly shire; press release in 2018), ipsen (press release in 2019), and galápagos (press release in 2020), all part of open pharma, have also implemented open access mandates. however, a subset of high-impact journals do not offer open access or do not offer the least restrictive open access license, cc by, to authors of pharma-funded research. to investigate this possible open access bias, we needed to benchmark and track open access publication patterns in different research settings in an objective and automated way. since 2018, we’ve analyzed and reported on open access rates of pharma-funded research using both manual and automated methods.13,15-17 this year, we collaborated with the lens platform to develop a free-to-use, publicly available open access dashboard that benchmarks and compares open access rates, types, and licenses between publications with authors affiliated to universities and those with authors from pharma companies. we presented a snapshot of the initial data as a poster at the 20th annual (us) meeting of the international society for medical publication professionals (ismpp) (2023).18 our research suggests that articles with university-affiliated authors are published with the most permissive license (cc by) more often than articles with pharma company– affiliated authors. however, our analysis was not designed to determine whether this difference is driven by journal or author policy. the open pharma dashboard will now help us to assess how changing perceptions of open access translate into changes in practice. data sharing survey. the potential benefits of coordinated data sharing are undisputed (eg, improved research transparency and efficiency of research), but so is the importance of protecting patient privacy. in some instances, intellectual property and data ownership may also be relevant considerations.19 expanding access to clinical study results and source data has important implications for research sponsors, authors, publishers, and patients, and most biomedical research journals now have data sharing requirements as a prerequisite of publication. open pharma designed a survey to assess the ease with which those involved in submitting pharma research for publication are able to implement current journal data sharing policies and to understand if there are barriers to implementation (eg, challenges in relation to certain study or data types) and related implications. to make sure our http://www.amwajournal.org https://www.openpharma.blog/wp-content/uploads/2021/08/pls-trs-plsp-crib-sheet_open-pharma_17aug21.pdf https://www.openpharma.blog/wp-content/uploads/2022/05/open-pharma-orcid-toolkit-2022.pdf https://www.openpharma.blog/wp-content/uploads/2022/05/open-pharma-orcid-toolkit-2022.pdf https://www.openpharma.blog/wp-content/uploads/2021/02/open-pharma-educational-materials-open-access.pdf https://www.openpharma.blog/wp-content/uploads/2021/02/open-pharma-educational-materials-open-access.pdf https://www.openpharma.blog/resources/ https://www.youtube.com/watch?v=mgkofi4z_ws https://www.ukri.org/what-we-do/supporting-healthy-research-and-innovation-culture/open-research/open-access-policies-review/#:~:text=uk%20research%20and%20innovation%20(ukri,published%20from%201%20january%202024. https://oir.nih.gov/sourcebook/intramural-program-oversight/intramural-data-sharing/2023-nih-data-management-sharing-policy#:~:text=the%20nih%20has%20issued%20a,products%20that%20improve%20human%20health. https://oir.nih.gov/sourcebook/intramural-program-oversight/intramural-data-sharing/2023-nih-data-management-sharing-policy#:~:text=the%20nih%20has%20issued%20a,products%20that%20improve%20human%20health. https://www.takeda.com/newsroom/shire-news-releases/2018/xajhds/ https://web.archive.org/web/20230201191040/https:/www.ipsen.com/ipsen-commits-to-making-all-its-published-scientific-research-freely-accessible-to-everyone/ https://web.archive.org/web/20230201191040/https:/www.ipsen.com/ipsen-commits-to-making-all-its-published-scientific-research-freely-accessible-to-everyone/ https://www.glpg.com/our-story/590/galapagos-commits-to-open-access-policy#:~:text=galapagos%20has%20committed%20to%20an,of%20its%20commitment%20to%20transparency. https://www.lens.org/lens/report/view/**open-pharma-open-access-analysis-dashboard**/14572/page/14573 amwajournal.org 11open pharma: driving positive change in the communication of pharma-sponsored research survey was intuitive to complete and that we were asking the right questions, it was also reviewed by the ismpp global transparency and trends committee. our results will help indicate whether there is a need to work with journals and publishers to optimize current data sharing policies for the benefit of all and, if so, where efforts should be focused. open pharma: a knowledge-sharing “club” open pharma events many conversations about the communication of pharma research take place in the absence of the voices of important stakeholders. this makes it difficult to understand their challenges and needs and to come up with appropriate solutions. to help bridge this communication gap, open pharma seeks to develop events that stimulate debate between stakeholders who do not often have the opportunity to meet and to bring fresh voices into the conversation. as an example, one of our highlights in 2022 was the open pharma satellite symposium held at the association of learned and professional society publishers annual conference and awards 2022. in the session “who can we trust? open science and pharma research,” presenters and audience members representing the pharma, publishing, and medical communication industries, as well as patient advocates, discussed the role of open science in building trust in pharma research, with a focus on open access publishing and accessible summaries.20 a video of the symposium is available on youtube, and a meeting report was published in a special issue of medical writing on the topic of “open science and open pharma.”21 more recently, in february 2023, open pharma ran 2 virtual talk shows facilitated by richard smith (open pharma chair, former editor of the bmj, and former chief executive of the bmj publishing group) that brought together patient advocates, doctors, policy advisors, charitable funders, open access advocates, and publishers. guests included richard horton (editor-in-chief, the lancet) and christine laine (editor-in-chief, annals of internal medicine). the discussions, which are available on youtube, were energetic and thought-provoking.22 bringing together such a wide range of views made it a unique event that will continue to spark further debate and collaboration. presence at congresses and other meetings open pharma is a regular presence at international meetings and events involving pharma industry professionals, publishers, and medical writers. in 2022 and 2023, we’ve held roundtables, workshops, and session presentations on open access and pls at the european and annual (us) meetings of ismpp, the council of science editors meeting, and the berlin and riga meetings of the european medical writers association. open pharma blog open pharma delivers open science news and commentary via our blog and e-newsletter. in addition to a weekly digest of short news stories, the blog features opinion and commentary pieces from expert guests (table 1). our blog is a platform for discussing key issues and trends in open science for pharma research and to signpost everyone to events of interest and useful tools and resources. open pharma: a forum for member voices topic meetings, roundtables, and working groups open pharma has a program of discussion meetings that provide opportunities for members and supporters to explore specific topics internally and with external guests. members and supporters also take part in working groups, which develop projects in several areas of open science. all these activities help the group identify unmet needs and potential solutions in the communication of pharma research. for example, the virtual roundtable meeting pharma and publishers forum on june 24, 2022, cochaired by caroline sutton (chief executive officer of stm publishing) table 1. highlighted guest blog posts from the open pharma blog guest blogs in 2022 how pharma will help move the needle on open research mark hahnel (founder and ceo of figshare) perceptions and insights on clinical trial participation: results from the 2021 ciscrp study jessica cronin (center for information and study on clinical research participation) open science: reflecting upon real-world impact (podcasts) martin delahunty (founder and managing director of inspiring stem consulting) guest blogs in 2023 improving equity through open access education catherine skobe (senior director, pfizer publications innovative solutions lead), adam watson (director, pfizer medical excellence lead in inflammation & immunology medical affairs), and j.r. meloro (global head of transparency, pfizer worldwide medical and safety) the changing open research landscape: a publisher’s perspective priti nagda (publications development manager at taylor & francis) and simon horton (policy and external affairs manager at taylor & francis) improve research discoverability to support health literacy catherine skobe (senior director, pfizer publications innovative solutions lead) and sally dews (senior medical affairs manager at pfizer patient partnerships) ceo, chief executive officer; ciscrp, the center for information and study on clinical research participation; stem, science, technology, engineering, and mathematics. http://www.amwajournal.org https://www.alpsp.org/ https://www.alpsp.org/ https://www.youtube.com/watch?v=z5f3vy6kq6c&t=2s https://journal.emwa.org/open-science-and-open-pharma/ https://www.openpharma.blog/blog/#sign-up-to-our-newsletter https://www.stm-assoc.org/ https://www.openpharma.blog/blog/opinion/how-pharma-will-help-move-the-needle-on-open-research/ https://www.openpharma.blog/blog/news/perceptions-and-insights-on-clinical-trial-participation-results-from-the-2021-ciscrp-study/ https://www.openpharma.blog/blog/news/perceptions-and-insights-on-clinical-trial-participation-results-from-the-2021-ciscrp-study/ https://www.openpharma.blog/blog/opinion/open-science-reflecting-upon-real-world-impact-podcasts/ https://www.openpharma.blog/blog/accessibility/open-access/improving-equity-through-open-access-education/ https://www.openpharma.blog/blog/accessibility/open-access/the-changing-open-research-landscape-a-publishers-perspective/ https://www.openpharma.blog/blog/guest-posts/improve-research-discoverability-to-support-health-literacy/ amwajournal.org 12open pharma: driving positive change in the communication of pharma-sponsored research and richard smith, brought together participants from the publishing and pharma sectors to discuss 4 core topic areas in open science – pls, open access, discoverability, and data sharing. the participants identified several unmet needs and potential solutions in these areas (table 2), which the open pharma working groups and other organizations can help to address. on the horizon for open pharma as the open access movement taking place across the publishing industry reaches new heights, open pharma will continue to campaign for equitable open access opportunities for all researchers. beyond open access, open pharma will continue to address other aspects of open science (and open research) by advocating for behaviors that promote greater transparency throughout the research life cycle. a key topic of interest is how to make research more accessible and discoverable, with nonexpert public and patient audiences being increasingly recognized as valid audiences for pharma research. the growth in plain language documents within and beyond research publications will also require more precise use of the terminology used to refer to these documents.20,23 open pharma will continue to champion best practice and cross-stakeholder collaboration in this area, working to expand the use and usefulness of pls. the use of natural language processing tools, including artificial intelligence (ai), in medical publications is a rapidly changing area, with many applications emerging for publication development, quality assessment, and regulation. open pharma will help keep our stakeholders abreast of this field and support them in using ai tools to improve research communication while maintaining publication integrity. summary thoughts medical writers can help to set standards of quality, transparency, and accountability in medical publications. through their work with researchers, authors, pharma publication teams, and publishers, medical writers can undertable 2. unmet needs and potential solutions identified at the open pharma roundtable pharma and publishers forum in june 2022 open science topic identified need possible solutions pls • establish methods for evaluating how much easier it is for nonexpert audiences to find and understand publications when these are accompanied by pls • develop quality standards for pls • explore ways of reducing the extra work that pls represent to publishers • continue to perform research and thought leadership on pls value and readership • convey the value of pls to stakeholders by sharing these efforts at conferences and in the literature • educate using open pharma’s best practice recommendations article open access • improve author appreciation of the value of open access publishing; reduce the traditional author focus on journal impact factor or citation score • simplify, or educate authors on, open access licensing agreements • explore issues of open access publication bias associated with article processing charges and possible solutions • provide evidence of the value of open access and existing bias through data-based research projects • provide training on the different types of publication license and what each means in terms of reuse, distribution, and adaptation • continue to promote mandatory open access publishing for industry-sponsored research • campaign for fee-waiving schemes for small pharma companies or companies from lower-income countries that may not have the budgets to pay high article processing charges • work with publishers on ways to update their systems to incorporate funder and pharma workflows for bulk publishing to reduce the administration burden and ensure use of intended licenses discoverability • explore search engine optimization for research outputs so that scientific data reach a wider range of audiences • explore the use of article-level metrics for assessing publication impact • ensure that keywords are carefully chosen and provided during submission to optimize discoverability of articles through search engines • promote use of text-based pls that are fully incorporated into the main manuscript alongside the abstract so they are hosted in front of any paywall and indexed on pubmed • discourage hosting of pls in supplementary material or on thirdparty content sites that are less likely to be accessed and read unless explicitly distributed to readers through other means data sharing • educate authors on optimal data sharing practices • harmonize pharma and publisher perspectives on preferred data storage platforms • explore the benefit of developing a universal data sharing guideline, including guidance around implications of – different data protection regulations among countries – disparities between pharma and publisher policies on data sharing • campaign for alignment to fair data management guidelines • develop training toolkits for authors on data sharing early in the research process • survey the industry to understand barriers to implementing current journal data sharing policies • create and share universal data sharing guidelines to help to build researcher and institutional confidence in complying with data sharing best practices fair, findability, accessibility, interoperability, and reuse of digital assets; pls, plain language summaries. http://www.amwajournal.org https://www.openpharma.blog/blog/guest-posts/the-changing-open-research-landscape-a-publishers-perspective/ https://www.openpharma.blog/blog/news/pharma-and-publishers-forum-an-open-pharma-roundtable-discussion-on-plain-language-summaries/ https://www.openpharma.blog/blog/news/pharma-and-publishers-forum-an-open-pharma-roundtable-discussion-on-open-access/ https://www.openpharma.blog/blog/discoverability/pharma-and-publishers-forum-an-open-pharma-roundtable-discussion-on-discoverability/ https://www.openpharma.blog/blog/news/pharma-and-publishers-forum-an-open-pharma-roundtable-discussion-on-data-sharing/ amwajournal.org 13open pharma: driving positive change in the communication of pharma-sponsored research stand the challenges of closed publications systems and witness the benefits of more open, collaborative, and audience-centric approaches. we invite the readers of this article to engage with open pharma by endorsing our open access position statement, encouraging your clients to use our resources and tools, and staying abreast of developments in the field by signing up to receive our newsletter. please contact us directly if you find any resources or activities that may be relevant to the open pharma audience or to discuss a collaboration. we believe that the appropriate application of open research principles can improve the quality and transparency of pharma research communication and, ultimately, improve patient care and increase health equity globally. everyone involved in the publication process can, and should, play a part. author declaration and disclosures: the author is an employee of oxford pharmagenesis. she has no commercial associations that may pose a conflict of interest in relation to this article. author contact: jo.gordon@pharmagenesis.com references 1. ipsos global trustworthiness monitor charts 2022. published 2023. accessed may 10, 2023. https://www.ipsos.com/sites/ default/files/ct/publication/documents/2023-01/ipsos-globaltrustworthiness-monitor-2022-charts.pdf 2. ipsos global trustworthiness monitor report 2022. published 2023. accessed may 10, 2023. https://www.ipsos.com/sites/ default/files/ct/publication/documents/2023-01/ipsos-globaltrustworthiness-monitor-stability-in-an-unstable-world.pdf 3. schulthess d, bowen hp, popovian r, gassull d, zhang a, hammang j. the relative contributions of nih and private sector funding to the approval of new biopharmaceuticals. ther innov regul sci. 2023;57(1):160-169. doi:10.1007/s43441-022-00451-8 4. haves e. research and development spending: pharmaceuticals. house of lords library. published 2022. accessed may 9, 2023. https://lordslibrary.parliament.uk/research-and-developmentspending-pharmaceuticals/ 5. rosenberg a, baróniková s, feighery l, et al. open pharma recommendations for plain language summaries of peerreviewed medical journal publications. curr med res opin. 2021;37(11):2015-2016. doi:10.1080/03007995.2021.1971185 6. rosenberg a, baróniková s, feighery l, et al. infographic: open pharma recommendations for plain language summaries of peer-reviewed medical journal publications. curr med res opin. 2022;38(6):881-882. doi:10.1080/03007995.2022.2072570 7. woolley kl, rosenberg a, halford c, soldavin k, smith r. clarifications and corrections on pubmed’s plain language summary requirements. curr med res opin. 2022;38(4):611-612. doi:10.1080/03007995.2022.2042994 8. beasley g, wilson s, wixon j, et al. how research assessment reform can help research to do more! reflections from the sdg publishers compact fellows, open climate campaign, and open pharma. published 2023. accessed july 7, 2023. https:// sfdora.org/2023/06/30/how-research-assessment-reform-canhelp-research-to-do-more-reflections-from-the-sdg-publisherscompact-fellows-open-climate-campaign-and-open-pharma/ 9. gattrell w. our pledge: summaries in plain language for all journal publications. ipsen. published 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openpharma.blog/wp-content/uploads/2021/04/freemanet-al_how-openly-accessible-is-pharma-sponsored-research-aninformatics-approach_ismppeu2021.pdf 17. ellison ts, koder t, schmidt l, williams a, winchester cc. open access policies of leading medical journals: a crosssectional study. bmj open. 2019;9(6):e028655. doi:10.1136/ bmjopen-2018-028655 18. philippon v, liew a, baróniková s, et al. benchmarking open access in publications with authors affiliated to pharma companies and universities. poster presented at: 2023 annual meeting of the international society for medical publication professionals; april 24–26, 2023; washington, dc. accessed april 25, 2023. https://www.congressposter.com/p/47hnk1uoz7ltsm5u 19. chisholm a, osório j. open pharma launches data sharing needs assessment survey. open pharma. published 2023. accessed july 4, 2023. https://www.openpharma.blog/blog/news/openpharma-launches-data-sharing-needs-assessment-survey/ 20. chisholm a. reflections and predictions at the turn of the year. open pharma. published 2023. accessed may 1, 2023. https:// www.openpharma.blog/blog/accessibility/open-access/ reflections-and-predictions-at-the-turn-of-the-year/ 21. chisholm a. can access and accessibility rebuild public trust in research? med writ. 2022;31(4):13-15. doi:10.56012/wzoz4567 22. osório j, chisholm a. open pharma talk shows available on youtube: listen, understand … act. open pharma. published 2023. accessed april 28, 2023. https://www.openpharma.blog/ blog/news/open-pharma-talk-shows-available-on-youtubelisten-understand-act/ 23. griffiths s, appiah a, rosenberg a, gonzalez j, baronikova s. landscaping the terminology of accessible language document types. med writ. 2022;31:24-30. doi:10.56012/cbxl1493 http://www.amwajournal.org https://www.openpharma.blog/#sign-up-to-our-newsletter https://www.openpharma.blog/contact/ https://www.ipsos.com/sites/default/files/ct/publication/documents/2023-01/ipsos-global-trustworthiness-monitor-2022-charts.pdf 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https://aoasg.files.wordpress.com/2013/02/benefitsofopenaccess_cc-by_logo.pdf https://www.nlm.nih.gov/pubs/techbull/jf19/jf19_february_pubmed_updates.html https://www.nlm.nih.gov/pubs/techbull/jf19/jf19_february_pubmed_updates.html https://www.openpharma.blog/wp-content/uploads/2021/01/how-open-are-pharma-publications_ismpp-eu-2020.pdf https://www.openpharma.blog/wp-content/uploads/2021/01/how-open-are-pharma-publications_ismpp-eu-2020.pdf https://www.openpharma.blog/wp-content/uploads/2021/01/how-open-are-pharma-publications_ismpp-eu-2020.pdf https://www.congressposter.com/p/6sa427fwxx70ol4w https://www.congressposter.com/p/6sa427fwxx70ol4w https://www.openpharma.blog/wp-content/uploads/2021/04/freeman-et-al_how-openly-accessible-is-pharma-sponsored-research-an-informatics-approach_ismppeu2021.pdf https://www.openpharma.blog/wp-content/uploads/2021/04/freeman-et-al_how-openly-accessible-is-pharma-sponsored-research-an-informatics-approach_ismppeu2021.pdf https://www.openpharma.blog/wp-content/uploads/2021/04/freeman-et-al_how-openly-accessible-is-pharma-sponsored-research-an-informatics-approach_ismppeu2021.pdf https://www.openpharma.blog/wp-content/uploads/2021/04/freeman-et-al_how-openly-accessible-is-pharma-sponsored-research-an-informatics-approach_ismppeu2021.pdf https://www.congressposter.com/p/47hnk1uoz7ltsm5u https://www.openpharma.blog/blog/news/open-pharma-launches-data-sharing-needs-assessment-survey/ https://www.openpharma.blog/blog/news/open-pharma-launches-data-sharing-needs-assessment-survey/ https://www.openpharma.blog/blog/accessibility/open-access/reflections-and-predictions-at-the-turn-of-the-year/ https://www.openpharma.blog/blog/accessibility/open-access/reflections-and-predictions-at-the-turn-of-the-year/ https://www.openpharma.blog/blog/accessibility/open-access/reflections-and-predictions-at-the-turn-of-the-year/ https://www.openpharma.blog/blog/news/open-pharma-talk-shows-available-on-youtube-listen-understand-act/ https://www.openpharma.blog/blog/news/open-pharma-talk-shows-available-on-youtube-listen-understand-act/ https://www.openpharma.blog/blog/news/open-pharma-talk-shows-available-on-youtube-listen-understand-act/ american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. listen to our podcast available on apple podcasts, google podcasts, and spotify become a medical writing master visit us at trilogywriting.com writers@trilogywriting.com www.trilogywriting.com/trilotalk think you have what it takes to join a world-leading team of medical writers? we’d love to speak with you. a podcast to discuss topics important for the profession of medical writing available on apple podcasts, spotify, youtube podcasts, and trilogywriting.com/trilotalk http://trilogywriting.com/trilotalk/ american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. listen to our podcast available on apple podcasts, google podcasts, and spotify become a medical writing master visit us at trilogywriting.com writers@trilogywriting.com www.trilogywriting.com/trilotalk think you have what it takes to join a world-leading team of medical writers? we’d love to speak with you. v38 n2 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 39 the jam session for seasoned freelancers is always a popular session at the annual amwa conference. the session gives seasoned professionals an opportunity to share concerns and challenges and to brainstorm and discuss solutions with experienced peers who have had similar experiences. several topics emerged at this year’s session, including the effect of covid-19 on businesses, client relationships, subcontracting, and business plans. effect of covid-19 the consensus among seasoned freelancers was that covid-19 was a boon to their businesses and their bottom lines. not only did they receive more projects from established clients, but new clients also approached them to assist with a variety of projects, including virtual events such as advisory boards, and these relationships continue as in-person events ramp up again. in the early days of the pandemic, freelancers were viewed as experts in working remotely. those who were experienced at creating virtual content sometimes had more work than they could handle. the effect covid-19 had on me is about the least newsworthy story of all time! the first vaccination required sitting in traffic for 2 hours to reach the injection station at our baseball park. the aftermath was no pain, no symptoms, and [paying] $50 for the hired driver. the follow-up second vaccine treatment was a phone call from [university of california san diego] health to go on campus immediately—private parking lot, 15-minute total injection/ follow-up, then no pain, no symptoms, nothing else. six months later, vaccination at local pharmacy—no pain, no symptoms, nothing else. finally, 6 months later came the double-dose vaccine—same pharmacy, same lack of aftermath. however, during that time period, i had a bad fall, ripped open 6 inches of leg skin, was hospitalized for 6 days, became infected with [methicillin-resistant staphylococcus aureus], underwent 2 sets of daily antibiotic infusions, [and] then [i took a] support antibiotic by mouth that made me nauseous. i tell this unrelated anecdote just so you won’t think i missed all the fun with the effects of covid-19! —phyllis minick i think everyone would agree that the whole covid pandemic time was an amazing, unexpected, and terrible phenomenon that none of us in the whole world could have predicted or were at all prepared to deal with. i would like to think that there were a lot of lessons learned from it. there will be research in so many areas on its impact for years to come, i’m sure. what a very strange time! for my freelance pharmaceutical regulatory writing business, though, i have to say that i was busier than ever during the main covid period. i almost felt guilty about having so much work when so many others did not. i donated a lot of money to the local food bank. i have always worked from home, so that was not an impact on me. i didn’t work on anything directly related to covid-19, but i had to adapt to (and teach clients about) ever-changing guidances about how to address the covid impact on clinical trials in clinical study reports. i highly recommend looking at the us food and drug administration guidance on this as well as the transcelerate-suggested clinical study report template wording. buckle up if you haven’t already! —sherri bowen * * * managing client relationships seasoned freelancers have reached the point in their careers in which they only want to work with clients who treat them well, pay them well (and on time), and supply enjoyable work. when clients fail to meet any of these 3 criteria, most jam session for seasoned freelancers freelance focus brian bass sherri bowen phyllis minickcathryn d. evans our freelance forum contributors—brian bass, sherri bowen, cathryn d. evans, and phyllis minick—have provided their own unique insights into topics raised during the open session during the educational session moderated by cyndy kryder, ms, mwc — “jam session for seasoned freelances.” http://www.amwajournal.org amwajournal.org 40jam session for seasoned freelancers seasoned freelancers don’t hesitate to end the relationship. doing so politely and professionally requires finesse. some seasoned freelancers prefer to say, “sorry, i’m busy,” when approached about future projects. others advocate taking a more transparent, honest approach and explain why they are ending the relationship. you should be able to identify which clients will appreciate this candor. your mental health is priceless. if you no longer enjoy working with a client, let them go. reviewing your client list on a quarterly basis can help you identify clients to avoid. “trust your gut” is a common mantra among seasoned freelancers. if intuition tells you something is not quite right about a client or a project, walk away. one of my earliest intros to freelancing involved a film maker who wanted to position his video in a forested state park. a business friend made the introductions, and an appointment to meet onsite followed, [that is], the 2 of us alone among the trees. in about 30 seconds came the hustle. i dodged and later complained to the friend who did the intro that i felt compromised. he responded, “if you can’t handle it, go back to the kitchen!” he was right! before undertaking the next such job opportunity, i wrote out samples of opening sentences (a greeting—name, contact info, business card), then invented strategies i had rehearsed aloud, such as script ideas, scenic equipment supplies, examples of texts submitted to journals—anything just to keep talking for the next few sentences. later, when i was more experienced, i substituted previously successful talking points and soon began such appointments with a contract in hand. included were samples from previously published manuscripts, scheduling protocol, payment requirements, over-run charges, and always a hold harmless sentence absolving me from any lawsuit regarding, for example, a medical product or equipment function. the latter strategy has served me well through decades of employment as an in-house editor and as a freelancer for medical institutions in 6 countries. —phyllis minick client management is full of unknowns! as a freelancer, i would like to think i have more control over choosing clients—but that doesn’t mean there will be a bad apple even when everything looked so nice at first. my main recommendation when negotiating with a brand-new client is to ask as many questions as you can about the project up front before signing on. for your long-term existing clients, it’s not unusual that companies you’re working for may undergo changes—mergers, new management, new approaches to things….make sure you find out what impact those changes may have on you so you can decide whether to stay or go. i’ve been let go by clients (for various reasons), and i’ve also divorced clients myself (but try to do that early on or when a contract is up for renewal). keep to commitments as much as you can, but it’s absolutely always ok to put yourself first. —sherri bowen * * * subcontracting subcontracting takes a lot of time and energy. not only do you need to find the right person for the project, but you also need to have the right client who will agree to let a subcontractor handle the work. when you subcontract, you are managing rather than doing the work yourself. consequently, your estimate needs to reflect the added project management time. never underestimate the time you will need to manage subcontractors and review deliverables. it takes longer than you think. subcontracting to other writers, editors, graphic artists, and consultants is an excellent way to increase income because you can mark up the work of others. the mark-up ranges from 20% to as much as 50%-75% (and more) by agencies. however, you can also lose a substantial amount of money by hiring inappropriate people. even if someone claims to be an experienced writer, editor, artist, designer, video producer, photographer, proofreader, etc.—and provides samples—that person can end up being too slow, unreliable, inexperienced, etc., for you to make money. sometimes it turns out that you not only cannot mark up the subcontractor’s time, but you end up taking a loss because you have to re-do the entire job and cannot possibly charge the client for all that time. hiring subcontractors has been one of the most difficult aspects of my business. today i hire subcontractors rarely, and then only those i know and trust. several other consultants and business owners who hire contractors and subcontractors have commiserated with me on this issue—it is a common problem. so yes, indeed, you can make more money if you have good subcontractors—but do it cautiously and be sure to check references. —cathryn d. evans i agree. if you think freelancing is tough, just wait until you start subcontracting. so why do it? because as wonderful as it is to work for yourself, having others work for you is even better—if you do it right. that’s the trick. when you start bringing in other freelance medical writers and/or medical editors, if you’re not very careful, you http://www.amwajournal.org amwajournal.org 41jam session for seasoned freelancers can end up working harder than you’ve ever worked before for less money than you’ve earned in years. why not just hire the people you need and put them on staff? because then you have to pay them whether they’re busy or not, deal with payroll taxes, health benefits, and vacation pay, and be tempted to force fit projects to the people you have instead of bringing in the best person for the job. it’s true that you have to manage the people to whom you’re subcontracting, and that means a lot of extra work if you’re lucky. you want to now be juggling more projects at the same time than ever; but with that comes more teleconferences, more estimating, more negotiating, more emails, and more bookkeeping, all of which takes time. and if you want to keep writing yourself instead of just managing, that adds a whole other level of complexity. how you subcontract is a crucial decision point; one that may provide some relief for you either now or down the road. for example, the people who work with me on a subcontracting basis are among the very best in the business. they’re deeply experienced and experts at their craft. they know what needs to be done and are self-motivated to do it. they have the confidence to make decisions and the ability to roll with the punches. for all these reasons and more, i don’t have to watch over the people i subcontract to or worry about how they handle clients, timelines, or budgets. they deliver a top-quality product every time, which is why i trust them with my reputation. in contrast, some people prefer to subcontract to medical writers or medical editors who are relatively new to the profession. the advantage is being able to train them in how you want things to be done, so in the future as they gain experience, they’ll deliver as you expect. there’s no right or wrong way to subcontract provided you’re completely transparent about it with your clients, and the way you structure your business works for you and those you hire. as noted during the jam session, your estimate for a project must include the value you bring to the table managing it. that’s right, but that’s not all! think of the infrastructure, the unbillable, the rare unthinkable. if all you factor into your estimates is a charge for your management time, you’re missing the entire point of subcontracting. you should also be making a profit on the entire project. there are only 8,760 hours in a year, and you can’t work all of them. the idea behind subcontracting is either to work less and earn as much as you did before, work as much as you did before and earn more than ever, or work less than ever and earn more than ever. —brian bass business plans some but certainly not all seasoned freelancers have created business plans they review and revise annually. businesses evolve over time as your skill set changes, technology changes, and your desires change. writing a business plan helps some freelance medical writers determine how they want their businesses to evolve and grow as well. you can find templates for business plans online by searching “business plan templates.” through the service corps of retired executives (score), a nonprofit resource partner of the us small business administration (sba), you can find a business expert to review your business plan. the sba has also established small business development centers throughout the country in which you can get advice about business planning. every business must have a plan and it should be in writing. if you choose not to do this, obviously you are not “in business,” you are a contract writer, which is okay, but it is not the same as owning/managing a business. before writing your business plan, think carefully about your product and your market. the business plan describes the nature of the business, its objectives, projected sales and profitability, future growth, etc., over an estimated period of time. it includes a summary as well as a detailed description of the market, marketing strategy, competitors, officers, directors, and other staff, an initial organization chart (and possibly projected future charts), operational strategy, and financial projections (expenses and income) for an estimated period of time (eg, 5 years). most businesses require the same specific functions. there is a chief executive officer, president. or proprietor. the functions of marketing director, sales manager, director of finance and accounting, bookkeeper, secretary, public relations officer, purchasing manager, etc., must be included. regardless of how you structure your business, someone has to perform these duties. include an organization chart with your written plan. if you perform all duties, insert your name into every box in the organization chart. check out the bookstores and the internet to see examples of such plans. i strongly recommend you take a (free) in-person workshop from score (www.score.org), which is an organization of experienced business people put together by the sba. they provide everything you need to know when starting out, including detailed information about why and how to create a business plan. write your business plan your own way, but do it! —cathryn d. evans to address the issue of business plans, i actually referred to a 2001 publication of selected amwa workshops.1 of course, the technologies have changed, but the basic elements not so much. author marilyn citron cited some essentials of planning for a freelance career as follows: http://www.amwajournal.org http://www.score.org amwajournal.org 42jam session for seasoned freelancers attributes [include] independence, autonomy, free choice of working time, opportunity to develop new skills and technologies, [and] broad choice of subjects. drawbacks [include] necessity to adjust for uneven workload and income, lack of health care insurance or retirement benefits, [and] isolation. recommendations for a business plan start with writing a mission statement as well as specifying client profiles, projected income, office and client locations, equipment/furniture costs and space, [and] detailed financial plan for both immediate and foreseeable long-term requirements. in the 2023 environment of formerly unequaled variety of communication opportunities, i cannot improve on a time-worn practice: “sit down and write a paragraph describing your prospective clients – who will need you and why. who will be best able to pay you well. then turn to internet directories and your own contacts to find prospective employers.”1 carefully document the advantages of a paycheck from an institutional employer [compared with] the uncertainties yet benefits of a freelance career. —phyllis minick unlock the secrets to freelance success with this 3-part on-demand video series. gain relevant and practical advice from industry pros. run your business like a pro. • essential ingredients of a successful freelance business • bad behaviors that can sabotage your business • getting the clients you deserve unlock now in amwa online learning: www.amwa.org/freelance_success http://www.amwajournal.org v38 n1 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 3 following a welcomed return to the in-person format of the amwa medical writing & communication conference in november of 2022, the spring 2023 issue of amwa journal is dedicated to exploring trends and opportunities in medical communication. this also marks the one-year anniversary of the journal’s transition to a digital platform, which by all accounts has been well received. in the current issue, among other topics, we explore the use of artificial intelligence and machine learning in clinical research and health care, updated guidance on reporting race and ethnicity, the value of medical writers in continuing education for health professionals, and we provide session reports from the annual conference. in subsequent issues this year, the themes will be publications (summer 2023, led by guest editor qing zhou), global medical communication (fall 2023, led by guest editor elizabeth kukielka), and ethics (winter 2023, led by guest editor julie ravo). as always, we welcome your contributions as authors, whether for a regular section, on a theme topic, or otherwise. please see the journal’s website for instructions for authors. back by popular demand, we are excited to announce that we will resume a section on career development to address issues of interest to those wishing to break into the medical communication profession, as well as career advancement for mid-stage and experienced professionals. we are recruiting for a career development section editor, so please contact me at journaleditor@amwa.org if you wish to be considered for the role. the amwa journal will continue to bring you great content every quarter, and on an ongoing basis, we invite your input on the digital format. michael g. baker, phd editor-in-chief from the editor http://www.amwajournal.org american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. v39 n2 / 2024 ©2024 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 16 abstract a high-performing medical writing team begins and ends with talented writers, editors, and leaders who understand their mission and their business. a panel of writers comprising the authors convened virtually on october 28, 2021, at the american medical writers association national conference to discuss this topic. the topics of value proposition and business models; communication, leadership, and corporate responsibility; and financial acumen are reprised in this 3-part series. the series also includes thoughts from the authors looking to the future of the business of medical writing, including what we can do in the medical writing community to introduce these topics earlier in the medical writing career path. this part 3 manuscript focuses on financial acumen. a high-performing medical writing team begins and ends with talented writers, editors, and leaders who understand their mission and their business: the value proposition, the finances that drive strategy and decision-making, the financial goals, and effective communication. a panel of writers comprising the authors convened virtually on october 28, 2021, at the american medical writers association (amwa) national conference to discuss this theme.1 the topics of value proposition and business models2; communication, leadership, and corporate responsibility3; and financial acumen are reprised in this three-part series, along with thoughts from the authors looking to the future of the business of medical writing, including what we can do in the medical writing community to introduce these topics earlier in the medical writing career path. this part 3 manuscript focuses on the importance of financial acumen and mastering fundamental financial concepts. the authors’ collective experience comprises the following medical writing work environments: • freelance business • small business/vendor • department leadership of smallto mid-size biotech company and large-sized pharmaceutical company the moderator’s (joan affleck ja) prompt is provided for each topic, followed by each perspective on the topic. in some cases, text from the session has been paraphrased for optimal clarity in this medium. financials ja: when we talk about success in business, a lot of times we talk—or think—about the money. i want to spend a few minutes to talk about money: cash flow, balance sheets, quarterly earnings, budget forecasting. these are terms that many medical writers are not really familiar with and don’t have a lot of practice with. so i would love to hear how you learned about those terms and practices and became comfortable with the financial aspects of business. dd: well, i don’t know if i ever became comfortable with them, but i certainly had to figure out how to work with them. it was really out of necessity when i started my business many years ago. and it was really to understand what made the whole thing a business—what defined a business legally and practically, how did you have to report your earnings, your obligations under tax requirements, and so on. there was a lot of education that had to happen because i came to [business] as a scientist from the bench; i didn’t have business training. i learned from the ground up, by my bootstraps, found a good accountant, and certainly asked many, many questions. at the end of the day it really comes down to—especially in the freelance setting—understanding (1) what you can do in a unit of time and how to translate that into successful project work for a client maintaining quality at a certain cycle time and (2) how fast can you do the work well and maintain things to keep it profitable. we are providing a business product in a business setting, and the product is a written document; so, you need to think about that all at once—you can’t really separate one from the other and hope for long-term success. joan affleck, mba; dominic de bellis, phd1; brian bass, mwc2; and jeanette m. towles, ma, rac-drugs3 / 1merck & co, inc, rahway, nj; 2bass global, inc, fort myers, fl; 3synterex, inc, dedham, ma part 3 in a 3-part series the business of medical writing: financial acumen topical feature http://www.amwajournal.org amwajournal.org 17the business of medical writing: financial acumen bb: i’d love to say i learned from the best. but really, i learned from the worst. i always learn more from my mistakes than i do from my successes; i analyze them deeper to understand what went wrong. i have a long history, before working for myself, of working for small companies—and i worked for great people, brilliant people, nice people, talented people, but none of them knew how to run businesses. as i sit here today, out of all the companies i have worked for in my life, only two are still in business, and i’m glad to say that one of them is mine. what i’ve done is pay attention to the mistakes that people made that led to downfalls. and one of the big ones that i see—and i think this crosses the board from freelance to people who work on staff—is [continuity]: the direct link between how much you get done, how well you do it, and your ability to be able to keep doing it and generate revenue (figure 1). when you work for a company, it can be a little easier to lose track of this direct link between your productivity and your ability to get a paycheck because there are so many other people factoring into that ability to get the paycheck. as freelancers, especially if you work independently, if you don’t work today, you don’t get paid tomorrow; if you take a week off, it makes things a little bit harder next month when you don’t have the same amount of revenue coming in. but where i see a challenge on the staff side is that many staff people lose that continuity. a lot of companies that have been my clients in the past have ultimately not succeeded because they spent so much more time working on projects than they had been scoped for. yes, those projects turned out to be absolutely fantastic, but the company wasn’t able to keep paying salaries at the end of the year or a couple of years down the line; it does have a ripple effect. ja: even in our shop it does. jeanette, how about for you? jt: my first exposure was right before i started the business. i was in-house, happily writing, and my boss stepped away from the department, unfortunately. so i pretty quickly found myself in a position where i basically had no context for the financial aspects of the department; i had to step in and be able to produce things like quarterly reforecasting and an annual budget, and lots of other fun things, so it was really a feet-to-the-fire moment for me. i learned a lot in that process but also enough to know that it’s not really the best way for people to learn that type of material; gradual exposure to it in a context where you can really understand how it connects to the day-to-day would be a much-preferred approach. so, fast-forward a few years to starting my own business and having to look at the balance sheet and all that: i really tried to take some of those concepts and infuse them into my operational team so that they understand. just as an example, we have to look at time sheets, and anything that is marked as nonbillable, we need to actually make sure is nonbillable and check on why—or if that is something that is supposed to be billed to a project. because, as brian mentioned, if you don’t check on those things, something that should be profitable can become unprofitable quickly, so you want your staff to really understand what that’s about—that you really do need to look at things at that level of detail in order to be responsible about the company. dd: jeanette, that’s a key point: in your company, you’ve decided proactively to really break down that barrier and share that information across your staff. brian, you have to do that by design—that’s what you follow to really manage the company’s activities day-to-day. for me, we have some visibility into those things, but the company has a whole finance department that handles that information, and they don’t often tell us the specific things that might or might not be helpful for us to know. it’s hard sometimes in-house to see clearly without [such] visibility, so that’s a challenge we have. overall, we know what makes for a good product, and we know what makes for efficiencies—and we hope that indirectly we are making a positive impact. ja: i think one of the key areas in talking about productivity and utilization is to get our staff comfortable with those terms and that it’s not a threat to talk about those things; it’s part of business because we have to be good financial stewards and good stewards of our people—our resources—as well. any tips on how to do that? dom, you mentioned being transparent about it. (figure 2) dd: yes, knowing what questions to ask about financial aspects is important, and i’m not sure if all medical writers ever really have the opportunity to figure out what they figure 1. linkage between productivity and revenue. http://www.amwajournal.org amwajournal.org 18the business of medical writing: financial acumen don’t know [through discussion]. they’d have to think about that and say, “i can balance my checkbook, but if i’m writing a protocol, what does it really cost if we have to amend the document?” understanding what those data are and what goes into the operational aspects of a clinical study, for example, are critical. just thinking about [a clinical study] as a commodity really brings home the business component. we have to remind the writers to put their pens down and look around them and say, “we’re in business, too.” bb: i spend a lot of time mentoring freelancers on the business aspects of freelancing. one of the biggest and most frequent questions that comes up is around estimating projects. i work on a project basis rather than on an hourly-rate basis, which is what drives that question. but it’s interesting when someone comes to me with project parameters and they want to know how much they should charge. to me, that’s not the question at all, and i get back to them with about 20 questions on the minuscule aspects of the project and the deliverable in order to wrap my mind around putting together that estimate. this is a muscle that freelancers need to constantly strengthen. when the questions you need to get answered to put an estimate together come naturally, that’s when you’re able to really estimate on a reliable and accurate basis. jt: i’ve noticed a continuity between the freelance and the in-house experience [in terms of] the concept of accruals. not only, prospectively, how much do you think this will take? but now that you’ve done it, where are we with this? sometimes there is a disconnect with the finance department not really understanding how much of the project is actually complete. especially if the company is in a position where they are about to do an ipo or something like that, they might be tracking things down to the dollar, and so sometimes on both sides of the fence, i’ve had to provide information about things like, if the project is a unit, it’s one-third done, and here’s where i think we will be next month. this requires communication with whoever you are partnering with, whether that’s in-house staff or a vendor, to know exactly where things are and if any difficulties have come up, in order to be accurate. ja: i love that comment, jeanette, and the idea of using these muscles in the corporate setting because, as dom said, there are often other people—other departments— that have this as their primary work, [but] for writers, it’s like a whole different sport. we haven’t used those muscles at all! so it’s a real call to action and embedding in our practice the idea of forecasting but then looking at the accruals. great comments! looking toward the future in part 1 of this 3-part series, the authors discussed how this panel was an initial dialogue meant to “kick off a broader discussion of the many aspects of business leadership as it applies to our work as medical communicators.”1 the authors concluded that having a comprehensive business curriculum—namely, a pathway whereby medical writers can readily learn the skills needed to demonstrate leadership while also participating in decision-making activities figure 2. utilization means ensuring the expected amount of revenue is generated compared with all available billable hours in a time period while accounting for indirect and direct overhead costs.4 http://www.amwajournal.org amwajournal.org 19the business of medical writing: financial acumen earlier in their careers—would benefit the writer toward the goal of developing a strategic mindset while learning fundamental business strategies and skills.2 in today’s dynamic business environment, the ability for employees at all levels to interpret key financial indicators is more crucial than ever. financial snapshots such as quarterly earnings reports provide invaluable insight into the health and trajectory of an organization. when employees have financial literacy baked into their corporate culture, they can not only grasp the current financial standing of the company but also gain a clearer vision of its future prospects and challenges.5 this understanding empowers employees to make informed decisions in their respective roles, align their strategies with their company’s objectives, contribute more effectively to the company’s overall success, and, as a result, fuel their own success as well. fostering financial literacy across all tiers of the organization can be a gamechanger in steering its direction and ensuring sustained growth. an employee’s ability to see the bigger financial picture can also be a boon to their career development, no matter what career path the employee ultimately chooses. an important component of financial literacy within the corporate culture is fostering an understanding of where and how revenue is generated, and developing a clear picture of how each employee contributes to that process. cash flow represents the lifeblood of a business,6 and a healthy business should have enough cash flow to meet its expenses, repay debts, reward investors, and fuel growth. for a freelancer or small medical writing business owner, the goal would be to balance necessary nonbillable tasks with billable ones. additionally, after a certain point, freelancers and small business owners may bring on vendors or partners to help maximize what they do best, which is generating revenue based on subject matter expertise and getting customers to return for repeat business.3 for employees whose work contributes directly to the bottom line, this metric is otherwise known as utilization4 (figure 2)—in other words, a calculation that ensures a resource is contributing the expected amount of revenue compared with all available billable hours in a time period while accounting for their indirect and direct overhead costs. examining this metric can help a freelancer or service provider understand whether they are charging enough for services, whether there is an appropriate number of staff, and whether the desired profit margin will be achieved. for an in-house writer, the concept of utilization differs slightly from the freelance or service provider scenario in that they are not directly generating revenue. however, most people in industry would agree that medical writers essentially sit in a place of revenue enablement (for example, medicinal products cannot get to market without documentation support for key clinical and regulatory stakeholders, and clinicians need to know about the results of clinical studies to determine a new treatment’s place within the current armamentarium). thus, utilization can be considered in a similar light in terms of how much time medical writing employees are investing on documents directly in support of revenue-enabling activities compared with purely administrative overhead. it all boils down to understanding what you can do with a unit of time and maximizing that contribution no matter the business model to help the company gain a competitive edge.2,3 the importance of understanding business concepts for all medical writers cannot be overstated, as it enables them to make informed decisions and drive their organizations toward success even in the face of volatility or change. pairing training in general accounting and financial concepts such as accounting methodology (accrual vs cash methods), financial software, budgeting, forecasting, interpreting financial statements, and bookkeeping, and specific training on the revenue generation, cash flow, and other relevant financial overview of the company, with a goal toward a broad culture of financial literacy, can help all medical writers (freelance and staff alike) allocate resources efficiently, assess performance, and ensure the sustainability of their businesses or departments. author declarations and disclosures: d. de bellis is employed by merck & co, inc, and is a shareholder. j. affleck, b. bass, and j. towles note no commercial associations that may pose a conflict of interest in relation to this article. author contact: jtowles@synterex.com references 1. amwa 2021 medical writing & communication conference registration brochure. amwa; 2021. accessed july 26, 2022. https://cdn.ymaws.com/www.amwa.org/resource/resmgr/ conference/2021/2021amwa_conf_program_june15.pdf 2. affleck j, de bellis d, bass b, towles j. the business of medical writing: understanding the value proposition and successful business models [part 1 in a 3-part series]. amwa j. 2023;38(2):21-25. https://doi.org/10.55752/amwa.2023.197 3. affleck j, de bellis d, bass b, towles j. the business of medical writing: communication, leadership, and corporate responsibility [part 2 in a 3-part series]. amwa j. 2023;38(4):20-26. https://doi. org/10.55752/amwa.2023.273 4. smartsheet. everything you need to know about utilization rates. accessed july 26, 2023. https://www.smartsheet.com/content/ what-is-utilization-rate-formula 5. webb s. why you should make financial literacy part of your company culture. forbes. september 18, 2020. accessed july 26, 2023. https://www.forbes.com/sites/ forbesfinancecouncil/2020/09/18/why-you-shouldmake-financial-literacy-part-of-your-companyculture/?sh=6b0b85aa2c39 6. thangavelu p. why cash management is key to business success. investopedia. updated december 26, 2022. accessed july 26, 2023. https://www.investopedia.com/articles/investing/041515/ why-cash-management-key-business-success.asp http://www.amwajournal.org https://cdn.ymaws.com/www.amwa.org/resource/resmgr/conference/2021/2021amwa_conf_program_june15.pdf https://cdn.ymaws.com/www.amwa.org/resource/resmgr/conference/2021/2021amwa_conf_program_june15.pdf https://www.smartsheet.com/content/what-is-utilization-rate-formula https://www.smartsheet.com/content/what-is-utilization-rate-formula https://www.forbes.com/sites/forbesfinancecouncil/2020/09/18/why-you-should-make-financial-literacy-part-of-your-company-culture/?sh=6b0b85aa2c39 https://www.forbes.com/sites/forbesfinancecouncil/2020/09/18/why-you-should-make-financial-literacy-part-of-your-company-culture/?sh=6b0b85aa2c39 https://www.forbes.com/sites/forbesfinancecouncil/2020/09/18/why-you-should-make-financial-literacy-part-of-your-company-culture/?sh=6b0b85aa2c39 https://www.forbes.com/sites/forbesfinancecouncil/2020/09/18/why-you-should-make-financial-literacy-part-of-your-company-culture/?sh=6b0b85aa2c39 https://www.investopedia.com/articles/investing/041515/why-cash-management-key-business-success.asp https://www.investopedia.com/articles/investing/041515/why-cash-management-key-business-success.asp american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. v38 n2 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 58 amwa president katrina r. burton called the meeting to order and provided a report about the accomplishments of the organization over the past year. amwa has seen a growth in membership and led successful virtual and in-person events. there has been continued engagement of executives and the value of medical writing initiatives. she expressed gratitude to the board of directors (bod), committee and task force members, and volunteer leaders who devoted their time and energy to lead amwa during this past year. on behalf of dr julie phelan, ms susan krug presented a financial report for the period of july 1, 2021, to june 30, 2022. ms burton announced that in accordance with the amwa bylaws, the nominating committee presented the following slate of officers for 2021-2022 to the amwa bod: • president-elect: r. michelle sauer gehring, phd, els • secretary: kim korwek, phd • treasurer: julie phelan, md, mba the amwa bod approved the slate, and the membership was notified of this slate 60 days before the annual meeting. the amwa bylaws contain a provision for additional nominations to be made in writing and no additional nominations were received. nominees who are unopposed are elected automatically at the annual business meeting. ms burton declared the slate to be the elected officers for 2022-2023, led by elise eller, phd, who as president-elect automatically assumes the office of president. ms burton passed the gavel to dr eller, who thanked the former president and expressed appreciation for having her leadership over the past year. dr eller shared highlights from her inaugural address and introduced the 2022-2023 amwa bod: r. michelle sauer gehring, phd, els / 2021-2022 amwa secretary 2022 annual business meeting for amwa members november 5, 2022, 4:00-4:30 pm mt amwa news officers: • immediate past president: katrina r. burton, bs • president: elise eller, phd • president-elect: r. michelle sauer gehring, phd, els • secretary: kim korwek, phd • treasurer: julie phelan, md, mba • executive director: susan krug, ms, cae chapter advisory council chair: • jennifer minarcik, ms at large directors: • loretta bohn, ba, els • sarah dobney, mph • lynne munno, ma, ms • shawn watson, pharmd, phd, bcps • joan affleck, ma, mba • joanna pendergrass, dvm • genevieve walker, phd the meeting was adjourned at 4:20 pm mt. 2022-2023 bod. top row: sarah dobney, genevieve walker, shawn watson, susan krug, loretta bohn, and kim korwek. middle: jen minarcik and lynne munno. seated: r. michelle sauer gehring, elise eller, katrina r. burton. not pictured: joan affleck, joanna pendergrass, and julie phelan. http://www.amwajournal.org american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. v38 n3 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 20 abstract there appears to be a collaborative nexus between the human body and its resident microbes. research shows strong associations between this parallel universe of microorganisms and our overall health, immunity, and behavior. the human microbiome consists of microbes that flourish in different parts of the body. our gut with all its projections spans nearly 7 kilometers in length and contains the largest number of microorganisms within the human body. an imbalance in the gut microbiome is strongly associated with allergies, metabolic diseases (eg, diabetes, obesity), neurological conditions (eg, depression, autism), respiratory diseases, liver diseases, and cancer. the development of the gut microbiome is a dynamic process that begins either during gestation or at birth and continuously evolves with human growth into adulthood. the gut microbiome is part of an intricate metabolic and signaling network in the human body. it communicates through biochemical pathways or axes with the skin, brain, lungs, kidneys, breast, and liver. a key motivation behind gut microbiome research is to confirm the cause-and-effect role of the gut microbiota on host health homeostasis. today, gut microbiome research is generating excitement due to its potential to prevent and treat several interrelated health conditions. conclusive evidence of the role played by the gut microbiome on human health will furnish new avenues of treatment and better insights into the influence of diet, environment, antibiotics, and genetics on the body. this article, the first of a two-part review, will discuss the relevance of the gut microbiome and its prominent constituents, the developmental trajectory of the gut microbiome from infancy to adulthood and its mutualistic relationship with the human host. today, medical research is dominated by an overwhelming interest in the human microbiome.1 because advances in health and medicine are of genuine public interest, results related to microbiome research are popular. in north america, there is a hype about the microbiome where nearly 94% of articles discuss only health benefits, whereas very few articles provide critical assessments or limitations of microbiome research.2 microbiome is a term that refers to the ecosystem that comprises genes, metabolites, and associated products of bacteria, fungi, viruses, phages, and archaea (box 1).3-7 there is a symbiotic relationship between human cells and the microbial community that dwells in the human body.8 in humans, there are approximately 39 trillion microbial cells, encoding nearly 20 million microbial genes.3,9-12 in contrast, human bodies with approximately 30 trillion human cells possess a little more than 20,000 human genes.12-14 this vast difference of a factor of 102 to 103 in microbial gene number has an impact on immunity, behavior, and health in humans. although studies on the effects of the microbiome on human health have been around for more than 50 years, a dedicated human microbiome project was initiated in 2007 by the national institutes of health to smitha s. dutt, phd / freelance medical writer, editor, and translator, montreal, canada the gut microbiome–human body symbiosis: relevance of the ubiquitous microbial community on health and development, part 1 science series microbiome an ecosystem of microorganisms (bacteria, viruses, phages, fungi, archaea), their genes, and metabolites in a particular environment. microbiota the microorganisms living in a particular environment, which include bacteria, viruses, fungi, archaea, and phages. dysbiosis changes to the composition of the gut microbiome (eg, function and taxonomy) cause dysbiosis as presented in a disease state. drastic disturbances to the gut microbial balance are linked to diseases, such as inflammatory bowel disease, obesity, type i diabetes, asthma, autism, and allergies. gut dysbiosis causes inflammation and immune reactions. alpha diversity the intraspecies diversity in a particular environment in an individual. vertical transmission transfer of bacteria and genes directly from mother to child box 1. http://www.amwajournal.org amwajournal.org 21the gut microbiome–human body symbiosis understand the physical and genetic structure of the microbiome.1,4,15 the first phase of this project studied the composition of different microbiomes (eg, skin, buccal mucosa, gut, feces, vaginal wall, tongue, outer ear cavity, and other sites) in the human body.15 a second integrative human microbiome project is studying the impact of 3 conditions– prediabetes, inflammatory bowel disease, and pregnancy– on the dynamic interaction between microbiomes and the human body.4,15 there is evidence of biased reporting of gut microbiome benefits on human health. by reporting results before they have been verified in large sample studies or randomized controlled trials, the public may be misled about the impact and benefits of the gut microbiome on our health.16,17 the following evidence-based review aims to provide a balanced overview of the gut microbiome and its role in the human body. relevance of the gut microbiome in the human body the gut or intestinal microbiome accounts for 99% (~ 1,000 to 4,500 species) of the entire microbial flora in the human body (table 1),5,11-13,18,19 making it the densest organ of metabolism on our planet. research has demonstrated the significant role of the gut microbiome in immune system maturation, vitamin production, energy production from dietary components, breakdown of complex sugars from plant-derived products and human milk, protection of the body against pathogenic bacteria, maturation and development of epithelial cells, and neurotransmitter production to facilitate communication with the brain.20-22 processed foods, high-fat diet, highprotein diet, low-fiber food, antibiotics, alcohol, and diseases cause inflammation and create an imbalance in the composition or dysbiosis of the gut microbiome.23,24 gut dysbiosis (box 1) appears to be associated with long-term impacts on the individual’s health in the form of allergies (eg, hay fever), gastrointestinal diseases (eg, inflammatory bowel disease [ibd], crohn’s disease), metabolic diseases (eg, obesity, diabetes, and cancer), neurological conditions (eg, depression, autism, alzheimer disease), and respiratory tract infections (figure 1).4,20,25,26 origins of the gut microbiome the first stage: seeding the development of the gut microbiome is a dynamic process.27 two theories explain the seeding of the gut microbitable 1. types of microbiota in the gut bacteria fungi viruses and bacteriophages archaea major phyla (term infants) major phyla (preterm infants) children adults infants maternal gut methanobrevibacter smithii methanosphaera stadtmanae order methanobacterialesproteobacteria firmicutes actinobacteria bacteroidetes verrucomicrobia firmicutes actinobacteria bacteroidetes aspergillus tremellomycetes phyla basidiomycota ascomycota genera saccharomyces penicillum aspergillus candida myoviridae, podoviridae, microviridae, and siphoviridae families microviridae circoviridae figure 1. the relevance of the gut microbiome in the human host. the 3 main roles of the gut microbiome are outlined in the figure. parts of the figure were drawn by using pictures from servier medical art. servier medical art by servier is licensed under a creative commons attribution 3.0 unported license (https:// creativecommons.org/licenses/by/3.0/). archaea cells icon by swissbiopics https:// www.swissbiopics.org/ is licensed under ccby 4.0 unported https://creativecommons.org/ licenses/by/4.0/. impact on the health of an individual • immune system modulation • vitamin production • digestion • neurotransmitter production • cytokine production • protection from pathogenic bacteria • iron absorption gut-organ axes gut-skin gut-brain gut-brain-skin gut-liver gut-lung gut-liver-kidney gut-liver-heart gut-liver-brain gut dysbiosis – health conditions • neurological – parkinson disease, alzheimer disease, depression, autism • gastrointestinal diseases – inflammatory bowel disease (ibd), celiac disease • liver diseases – hepatic steatosis, non-alcoholic fatty liver disease (nafld) • allergies – asthma • metabolic diseases – obesity, diabetes • skin diseases – psoriasis, • cancer gut microbiome (archaea, fungi, bacteria, bacteriophages, viruses) gut-organ axes gut-skin gut-brain gut-brain-skin gut-liver gut-lung gut-liver-kidney gut-liver-heart gut-liver-brain impact on the health of an individual • immune system modulation • vitamin production • digestion • neurotransmitter production • cytokine production • protection from pathogenic bacteria • iron absorption gut dysbiosis – health conditions • neurological – parkinson disease, alzheimer disease, depression, autism • gastrointestinal diseases– inflammatory bowel disease (ibd), celiac disease • liver diseases – hepatic steatosis, non-alcoholic fatty liver disease (nafld) • allergies – asthma • metabolic diseases– obesity, diabetes • skin diseases – psoriasis, • cancer http://www.amwajournal.org https://creativecommons.org/licenses/by/3.0/ https://creativecommons.org/licenses/by/3.0/ https://www.swissbiopics.org https://www.swissbiopics.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ amwajournal.org 22the gut microbiome–human body symbiosis ome in humans.8,23,28 bacteria initially colonize the immature gut of infants followed by viruses and fungi.23,29,30 sterile womb hypothesis. this hypothesis states that the uterus of a pregnant person is a sterile environment, and microbial colonization of the fetal gut begins at birth during labor.8,31,32 when the amniotic sac ruptures in a vaginal birth, the fetus is exposed to and enveloped by the mother’s vaginal microbiome as it makes its way through the birth canal. babies born via elective cesarean section have a gut microbiome that resembles the mother’s skin microbiome.3,8,13,33 infants born from an emergency c-section have gut microbiota that resemble the mother’s skin and vaginal microbiomes.3,8,13,33 in the term infant, the gut is randomly colonized initially by pioneer colonizers or microbiota (box 1) from different sites of the mother’s body (eg, skin, mouth, gut, vagina, breastmilk).28,30-32 in the first week of birth, the infant’s gut is aerobic and has a neutral ph. facultative anaerobic bacteria (growing with or without oxygen) act as pioneer colonizers (box 1, table 2).28,31,32 they then reduce in number as obligate anaerobes (table 2) begin to proliferate in the gut. as the infant grows, the ph of the gut changes. facultative anaerobes become predominant in the gut, signaling a shift in oxygen conditions. these robust microbes are vertically transmitted (box 1) from the mother to the child.32 after 6 days of life, there is a transition to bifidobacteria species that use human milk oligosaccharides (hmos) as a source of carbon (figure 2).3,23 in utero hypothesis. in contrast, this controversial hypothesis suggests the fetal gut microbiome is seeded during gestation when the fetus is exposed to the microbiota of the placenta or amniotic fluid. placenta, amniotic fluid, and meconium–once considered sterile–are now being shown to be occupied by microbial communities. preterm babies are exposed to amniotic fluid microbiota due to urinary infections (premature rupture of membranes) or chorioamnionitis (infection within the amniotic sac and the surrounding fetal membrane) during gestation.25,34-38 controversies. critics argue against the presence of microbiota in these sterile sites and suggest that laboratory contamination may be the potential source. these microbiota could also seed the neonatal gut via vertical transmission from the mother to the fetus (eg, breastmilk).6,25,34,39 the second stage: weaning the infant’s gut microbiome undergoes a significant change during weaning when they are introduced to a solid diet.3,23,40 the gut microbiome is compelled to mature and increase in diversity when the complexity of carbohydrate and starch components increases. there is a decrease in bifidobacterium and other obligate anaerobic species. this stage of maturation sees the predominance of the phylum table 2. seeding microbes facultative anaerobes obligate anaerobes term infants prevotella melaninogenica, haemophilus parainfluenzae, enterobacteriaceae members, alistipes putredinis, staphylococci, streptococci bifidobacteria, clostridia, eubacteria spp, and bacteroides preterm infants staphylococcus, enterococcus, enterobacteraceae, bifidobacterium delayed colonization – bifidobacteria, lactobacillus, and bacteroides figure 2. seeding and stages of development of the gut microbiome. successive stages in gut microbiome development in preterm and term infants are outlined in the figure. predominant bacteria at each stage of succession are indicated. http://www.amwajournal.org amwajournal.org 23the gut microbiome–human body symbiosis bacteriodetes and clostridia species.23,28,31,40 the gut flora is distinctly different in children aged 4 months, 12 months, 3 years, and 5 years.3,23,29,41 as the infant grows through the first year of life, the alpha diversity (box 1) increases when solid foods are introduced in the diet (figure 2).25,27,37 the third stage: stabilization of gut flora during growth into adulthood there is limited information on the gut microbiomes of children and adolescents. the evolution of the gut microbiome stabilizes in children after 5 years of age and appears to resemble that of adults. the 5 major phyla in an adult gut are firmicutes, proteobacteria, bacteroidetes, actinobacteria, and verrucomicrobia. microbial content, however, differs and is influenced by diet, geographical location, and use of antibiotics.3,8,29,41-43 bacterial genera of the adult gut do not resemble the genera found in children younger than 3 years.29 with the progress to adulthood, bifidobacteria abundance reduces along with subsequent enrichment of firmicutes and bacteroidetes in the adult microbiome.44 factors influencing gut microbiota normal development of the gut microbiome with increasing species diversity from birth is essential to the future health of the individual.27 several factors enhance or impede the microbial balance in the gut. term infants in a term neonate, vaginal birth, good maternal health, breastmilk, and probiotics enhance the diversity of gut flora. antibiotics, hospitalization, and smoking (table 3) give rise to antimicrobial resistance genes and facilitate the growth of facultative anaerobic pathogenic bacteria.8,13,39,45,46 the type of mother’s diet, c-section birth, formula feeds, bovine-milk-fortified human milk, and the environment (eg, living with family members, daycare, pets, rural or urban lifestyle, an industrialized environment) influence gut flora maturation in different ways.8,28,30 gut microbiota of infants born via c-section and/or fed formula are very diverse and closely resemble mature microbiota of adults.23 in addition, chemical factors (ph, bile acid, mucus), microbial factors (adhesion capability, metabolic pathways, bacterial enzymes), and bacteriophages influence gut microbiome diversity.5,21 preterm infants preterm infants show delayed development of microbial diversity and a distinct difference in species composition (table 4) from those of age-matched term infants before 6 months.25,37,47 microbial colonization may occur prior to birth because of complications during gestation.13,33,36 gestational age plays a major role in the initial colonization and microbial diversity of the preterm infant’s gut.47 other factors include genetics, sex, the mode of feeding (enteral; parenteral; breastfeeding), type of milk (breastmilk; formula, donor milk); pumping and storage of milk, and the environment (hospital; intensive care unit; medical interventions; antibiotics; family members).13,27,33,37,44,45,48-51 impact of changes in microbial diversity gut microbiomes of children are more susceptible to changes in diet, environment, and antibiotics than those of adults. babies born via c-section appear to be predisposed to developing obesity and celiac disease.8,41 antibiotic treatment reduces microbiota diversity, leading to antibiotic-related obesity, multidrug resistance, and asthma. gut health could be restored when treated with beneficial bacteria.23,41 the quality of microbial diversity in the gut is table 3. gut bacteria in term infants vaginal escherichia coli, lactobacillus spp, enterococcus bifidobacteria (eg, bifidobacterium breve, prevotella spp, bifidobacterium bifidum, bifidobacterium adolecscentis, bifidobacterium longum), sneathia spp, streptococci, atopobium vaginae and gardnerella vaginalis, bacteroides, fecalibacteria, parabacteroides, lachnospiraceae, ruminococcaceae, christensenallaceae, roseburia, anaerostipes c-section klebsiella, clostridium, staphylococcus, haemophilus, veillonella, propionibacteria, proteobacteria, enterococcus spp, corynebacterium spp, other ruminococcaceae variants, bifidobacterium spp↓, lachnospiraceae, and bacteroidaceae species↓ breastmilk enterobacter, streptococci, acinetobacter, staphylococci, bifidobacteria, lactic acid bacteria, pseudomonas formula clostridium difficile, bacteroidetes (bacteroides fragilis), staphylococci, atopobium, enterobacteria, enterococci, and firmicutes lactobacilli, escherichia coli table 4. gut bacteria in preterm infants c-section enterococci, enterobacteraceae, staphylococci, klebsiella, mycoplasmataceae (↑ in chorioamnionitis), bacteroidetes↓, escherichia, bifidobacteria ↓, veillonella, lactobacilli ↓, coprobacilli, desulfovibrio, carnobacteria, phascolarctobacteria, gammaproteobacteria, firmicutes, shigella, clostridia ↓, atopobium ↓, sneathia sanguinegens, fusobacterium nucleatum breastmilk staphylococci, corynebacteria, pseudomonas, streptococci, acinetob formula bifidobacteria and clostridiales antibiotics firmicutes and proteobacteria hospitalassociated klebsiella pneumoniae, yersinia, enterococci, serratia, granulicatella, proteus, enterobacter aerogenes, escherichia coli dietassociated ruminococcus bromii, bacteroides vulgatus, lactococci, ruminococcus obeum butyrate producers eubacterium hallii, anaerostipes caccae, coprococcus eutactus http://www.amwajournal.org amwajournal.org 24the gut microbiome–human body symbiosis crucial and dependent on the interplay of different factors. despite breastfeeding, malnutrition reduces alpha diversity (increased prevalence of proteobacteria) and slows down growth in children.3,23,29,43 a western diet of low-fiber and high-fat processed foods increases the presence of bacteroides and reduces overall alpha diversity. numerous health conditions (eg, obesity, ibd, cancer) appear to be associated with reduced alpha diversity.23,52 in contrast, high-fiber diets increase microbial diversity and overall health in rural populations in asia and africa.23,40,41,52 geographical location appears to influence microbial diversity. people living in industrialized urban areas exhibit lower gut microbial diversity than those who live in rural areas.42,52 gut microbiome network the gut microbiome does not act in isolation. instead, microbiota or its metabolites travel to other sites of the human body and interact with their microbiomes through bidirectional or multidirectional pathways. this complex network explains the influence of the gut microbiome on our immunity, health, and even our emotions (figure 1). some of the gut axes are gut-liver,24 gut-lung,10,24,53,54 gutbrain, gut-skin, gut-liver-kidneys,24 and gut-brain-liver.24 disruption to the normal functioning of these axes results in diseases such as chronic kidney disease, hepatic encephalopathy, and cardiovascular disease, nonalcoholic fatty liver disease, chronic obstructive pulmonary disease, asthma, and cystic fibrosis.10,24,53,54 these conditions are often linked to gastrointestinal diseases. this article will focus on the gutskin, gut-brain, and the gut-breastmilk axes. gut-skin axis the biochemical interactions between the skin and gut microbiomes are bidirectional.28 a dysbiotic gut microbiome may induce changes to the skin microbiome with the release of proinflammatory cytokines. this allows gut bacteria or their metabolic byproducts and toxins to enter the systemic blood circulation. the gut bacteria reach the skin and affect the integrity of the skin barrier. the resulting inflammation has been linked to chronic skin disorders (eg, psoriasis, acne, alopecia).55,56 gut-brain axis according to preclinical research, there are bidirectional interactions between the gut, brain, and the gut microbiome (gbm). the gut-brain axis comprises the autonomic nervous system, the gut microbiota with its metabolic products, the enteric neuroendocrine system, the hypothalamic-pituitary-adrenal system, the enteric nervous system, and the gut-associated immune system.36,57 research has shown that bacteria, their metabolites, and immune cells have access to the brain through the blood brain barrier (bbb).22,58 gut bacteria belonging to the genera bifidobacteria, streptococci, escherichia, lactobacilli, and enterococci regulate the production of neurotransmitters (eg, gaba, serotonin, and acetylcholine), which pass through the bbb and modulate brain signaling directly or indirectly. interactions between the nervous system and the immune system are also affected. people suffering neurological, psychiatric, and degenerative conditions (eg, depression, anxiety) also display perturbations in the diversity of their gut microbiome (eg, ibd, chronic abdominal pain).22,57-59 gut-brain-skin axis the gut-brain-skin axis is gaining relevance in the consistent link between skin conditions (psoriasis, acne) and mental health (depression). the central nervous system (cns) is regulated by neurotransmitters transmitted from the gut microbiota through the vagus nerve. neurotransmitters facilitate the interactions between the nervous system and immune responses to skin inflammation. mental health conditions (eg, depression) and skin conditions (eg, psoriasis) generate cytokines (eg, il6) from the brain and the skin. this causes inflammation. simultaneously, cns conditions (eg, depression or anxiety) appear to cause gut dysbiosis and increase the permeability of the gut epithelial cells (leaky gut). gut microbiota and their metabolites enter the bloodstream and trigger inflammation on the skin and in the brain.58,60 human breastmilk – enteromammary hypothesis breastmilk may play a role in seeding the infant microbiome. a quarter of the infant’s gut microbiota is obtained from breastmilk, which influences its development over the individual’s lifetime and protects against potential allergies.61,62 the enteromammary hypothesis suggests that bacteria travel from the mother’s gut to the lactating breast and create the breastmilk microbiome. however, this hypothesis is based on a small sample size.51,61,63 human breastmilk contains bioactive compounds (secretory immunoglobulin a,64 growth factors, >200 hmos, cytokines), immunological compounds, nutrients, and maternal gut microflora. bioactive compounds help to develop a robust immune system in the infant.8,44,61 as prebiotics and a source of bioactive compounds, hmos are digested by microbiota, such as bifidobacteria, in the large intestine because humans lack the enzymes to metabolize hmos in the small intestine. hmos (elaborate sugar complexes) are a major source of brain nourishment and prevent the growth of infectious pathogens.8,44,61 the components of breastmilk change dynamically at each developmental stage of the infant.65 http://www.amwajournal.org amwajournal.org 25the gut microbiome–human body symbiosis conclusion despite strong associations, the vital question persists: does a health condition cause gut dysbiosis, or is the reverse true?22,23 this topic is ripe for debate as misinformation influences public opinion. unfortunately, it has been noted that the general population prefers to acquire information from nonmedical independent sources.17 popular content (eg, articles or videos) lack reliable peer-reviewed sources to support their claims on the benefits of products, such as probiotics or yogurt, on human health.2,17 however, responsible reporting is warranted. accurate data interpretation could influence future health policies.1 to preserve scientific integrity, it is our responsibility as medical writers to ensure that facts and research findings on the gut microbiome are validated and appropriately disseminated. data from large randomized clinical trials should be cautiously interpreted by assessing the relevance of statistical tests used or by distinguishing associations from cause-and-effect. when statistical data are accurately interpreted in the larger context of the human population, the significance of the results is more convincing. although gut microbiome research is under the influence of the “health halo,” we cannot deny the existence and the involvement of this extensive microbial community in human health.2 established as an integral part of the complex, interconnected human signaling network, the gut microbiome and its manipulation could soon form a key aspect of the diagnostic and treatment landscape. acknowledgments i thank dr naomi bishop for her insightful comments and for her review of the article. author declaration and 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the-microbiomes-of-indigenous-peoples-are-different-does-itmatter/ 53. tirone c, pezza l, paladini a, et al. gut and lung microbiota in preterm infants: immunological modulation and implication in neonatal outcomes. front immunol. 2019;10:2910. doi:10.3389/ fimmu.2019.02910 54. enaud r, prevel r, ciarlo e, et al. the gut-lung axis in health and respiratory diseases: a place for inter-organ and inter-kingdom crosstalks. front cell infect microbiol. 2020;10:9. doi:10.3389/ fcimb.2020.00009 55. thye ayk, bah yr, law jwf, et al. gut–skin axis: unravelling the connection between the gut microbiome and psoriasis. biomedicines. 2022;10(5):1037. doi:10.3390/ biomedicines10051037 56. de pessemier b, grine l, debaere m, maes a, paetzold b, callewaert c. gut–skin axis: current knowledge of the interrelationship between microbial dysbiosis and skin conditions. microorganisms. 2021;9(2):353. doi:10.3390/ microorganisms9020353 57. mayer ea, nance k, chen s. the gut–brain axis. annu rev med. 2022;73(1):439-453. doi:10.1146/annurev-med-042320-014032 58. chen g, chen z, fan x, et al. gut–brain–skin axis in psoriasis: a review. dermatol ther. 2021;11(1):25-38. doi:10.1007/s13555-02000466-9 59. anand n, gorantla vr, chidambaram sb. the role of gut dysbiosis in the pathophysiology of neuropsychiatric disorders. cells. 2022;12(1):54. doi:10.3390/cells12010054 60. wang x, li y, wu l, et al. dysregulation of the gut-brainskin axis and key overlapping inflammatory and immune http://www.amwajournal.org https://blogs.scientificamerican.com/food-matters/the-microbiomes-of-indigenous-peoples-are-different-does-it-matter/ https://blogs.scientificamerican.com/food-matters/the-microbiomes-of-indigenous-peoples-are-different-does-it-matter/ https://blogs.scientificamerican.com/food-matters/the-microbiomes-of-indigenous-peoples-are-different-does-it-matter/ amwajournal.org 27the gut microbiome–human body symbiosis mechanisms of psoriasis and depression. biomed pharmacother. 2021;137:111065. doi:10.1016/j.biopha.2020.111065 61. wallenborn jt, vonaesch p. intestinal microbiota research from a global perspective. gastroenterol rep. 2022;10:goac010. doi:10.1093/gastro/goac010 62. daiy k, harries v, nyhan k, marcinkowska um. maternal weight status and the composition of the human milk microbiome: a scoping review. plos one. 2022;17(10):e0274950. doi:10.1371/ journal.pone.0274950 63. kordy k, gaufin t, mwangi m, et al. contributions to human breast milk microbiome and enteromammary transfer of bifidobacterium breve. plos one. 2020;15(1):e0219633. doi:10.1371/journal.pone.0219633 64. janzon a, goodrich jk, koren o, the teddy study group, waters jl, ley re. interactions between the gut microbiome and mucosal immunoglobulins a, m, and g in the developing infant gut. msystems. 2019;4(6):e00612-19. doi:10.1128/msystems.00612-19 65. overgaard poulsen k, astono j, jakobsen rr, et al. influence of maternal body mass index on human milk composition and associations to infant metabolism and gut colonisation: mainhealth – a study protocol for an observational birth cohort. bmj open. 2022;12(11):e059552. doi:10.1136/ bmjopen-2021-059552 www.amwa.org/mwc three little letters. one big deal. apply now apply by october 17 for december 2023 exam. review our applicant handbook, candidate guide, and study tips to help you prepare. http://www.amwajournal.org v38 n2 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 68 abstract in 2022, the american medical writers association (amwa) established a taskforce to develop a survey to understand the current state of medical writer apprentice programs and the desire for a standard framework to help guide the development of such programs. the survey was targeted to contributors who were actively responsible for leading and/or training and developing a medical writing team and was administered by using surveymonkey. a total of 78 responses were received, with the largest percentage of respondents primarily working in pharmaceutical/biotech/medical device companies (44%), followed by contract research organizations (cros)/medical writing companies (23%), and medical writing consultancies (10%). the survey revealed that less than half (42%) of survey respondents’ companies currently have an established apprentice program, and that cros (73%) and medical writing-specific consultancies (57%) were more likely to have apprentice programs than pharmaceutical/biotech/device companies (24%). the respondents also provided details about the goals, training styles, structures, and durations of existing programs. importantly, regardless of whether respondents’ companies already have an apprentice program, the majority of respondents felt it would be useful to have a standard framework for an apprentice program either to refine existing programs or to develop a new program. therefore, the amwa executives advisory council established an apprenticeship framework working group to develop a standard yet flexible framework for companies to use as an adaptable resource as they develop their own apprentice programs. the development of this framework is ongoing at the time of publication of this article. interest in the medical writing profession has increased over recent years, with candidates ranging from university graduates to those seeking a career change from within or outside the health care industry. furthermore, demand for experienced medical writers continues to be very high, with the estimated value of the global medical writing market forecasted to more than double in the next several years (from $3.8 billion in 2022 to $8.4 billion in 2030).1 novel approaches are therefore necessary to sustainably develop a pipeline of new talent, and the need for structured development programs for new medical writers has emerged. apprenticeships or similar trainee programs have been successful for some companies to bring new writers into the profession and ensure their development. the american medical writers association (amwa) executives advisory council established a taskforce in 2022 to learn more about existing apprenticeships/trainee programs. the team also sought to determine whether companies without such a program would find a framework useful, should they pursue this option. consequently, a survey was developed to explore the above. the results of the survey were presented at the amwa 2022 executive forum to kick off a full-day discussion on apprentice programs.2 survey design and objectives the survey was administered by amwa anonymously (respondent and company names were optional) via an online platform (surveymonkey) and targeted contributors who were actively responsible for leading and/or training and developing a medical writing team, regardless of the types of documents they produced (eg, regulatory, publications, medical communication). to gain as much information as possible, respondents were encouraged to forward the survey to other eligible individuals within their organization. the survey was also posted on the amwa site and promoted via social media. an option to do a brief interview with a taskforce member to gather additional details of the organization's apprentice program was included at the end of the survey. apprenticeships/trainee programs are referred to as “apprentice programs” throughout this article and are generally defined as programs that seek to develop entry and/or junior-level medical writers over an extended period (>6 months). training topics for this type of program go beyond the standard training program all companies are medical writer apprentice programs: who has them, what are they like, and do we need more? survey results from 2022 kim jochman,1 rona claire grunspan,2 jeanette towles,3 rona vasey,4 linda yih,5 on behalf of the amwa apprenticeship framework working group / 1merck & co, inc, rahway, nj; 2icon plc, dublin, ireland; 3synterex, inc, dedham, ma; 4trilogy writing and consulting, frankfurt, germany; 5parexel international, llc, usa amwa news http://www.amwajournal.org amwajournal.org 69medical writer apprentice programs: survey results required to have in place (eg, to meet good clinical practice requirements). recognizing the limitations on respondents’ availability for such a survey, we developed a set of questions that would capture key points on training programs. these questions targeted program goals, training topics, methods and structure, training source, duration, and whether a standard framework would be useful to further develop their program. most of the questions were multiple choice and included an “other (specify)” option where appropriate. the survey also included a checkpoint question to direct respondents who did not have an apprentice program to a set of follow-up questions regarding whether they had plans to implement such a program within 2 years and whether a standard framework would be useful as a starting point. for those who agreed to follow-up interviews, we prepared 5 questions. these elaborated on what prompted the development of an apprentice program, components of their program, how training is structured, and overall feedback or lessons learned. after beta testing, the survey opened in late july 2022 and was available until early september 2022. interim views of the data were done in august to confirm adequate participation, and follow-up interviews were conducted during september to early october 2022. survey respondent profile among 78 survey respondents, the largest percentage noted their primary work setting as pharmaceutical/ biotech/medical device companies (44%), followed by contract research organizations (cros)/medical writing companies (23%) and medical writing consultancies (10%). the majority (63%) of the respondents primarily focus on regulatory writing, and most (82%) have a role in training and developing medical writers as part of their job duties (figure 1). among 66 survey respondents who provided information regarding the approximate number of medical writers in their company (excluding contractors and nonwriting managers), the majority (58%) were in departments that have fewer than 20 medical writers, with an approximately equal number of respondents from companies with 20-50 (14%), 51-100 (14%), or more than 100 (15%) medical writers. junior-level writers were largely noted to comprise up to 50% of the writers in these departments (73% of respondents), with some groups having a higher percentage of junior writers (figure 2). figure 1. survey respondents by primary work setting and primary writing focus. figure 2. approximate size of respondents’ medical writing teams and percentage of junior-level medical writers within those teams. http://www.amwajournal.org amwajournal.org 70medical writer apprentice programs: survey results of note, some companies had more than 1 survey respondent; however, it was not possible to identify the exact number of companies with multiple survey respondents because the self-reporting of the organization/ company name was an optional question and was only completed by 38 of the 78 survey respondents. in addition, it is possible that respondents from the same company were responding about different medical writing departments within that company. as such, all survey responses from each company were retained. what types of companies have apprentice programs? of the 66 respondents to the question, “does your company have an established apprenticeship or training program,” 42% responded “yes.” the “yes” responses were summarized by type of work setting, primary writing focus area, size of medical writing team/department, and percentage of junior-level medical writers (table 1). the following trends were noted: • for the most common types of work settings, cros (73%) and medical writing-specific consultancies (57%) were more likely to have apprentice programs than pharmaceutical/biotech/device companies (24%). • medium (20-50 medical writers) to larger-sized (51100 medical writers, >100 medical writers) organizations were more likely to have apprentice programs than smaller organizations (<20 medical writers). • medical writing organizations composed of 25%-<50% junior-level medical writers were more likely to have number (%) with apprentice programs total number of respondents in category n % n all respondents 28 42.4 66 respondents by type of work settinga pharmaceutical/biotech/medical device company 8 24.2 33 contract research organization/medical writing company 11 73.3 15 medical writing-specific consultancy 4 57.1 7 research or academic institution 1 25.0 4 medical communication company/agency 3 75.0 4 hospital, clinic, other health care facility 0 0 1 other (please specify) 1 50.0 2 respondents by primary writing focusb regulatory writing 19 44.2 43 scientific publications (peer-reviewed) 4 40.0 10 regulatory and communication writing 1 20.0 5 medical affairs 2 66.7 3 patient education 0 0 2 publications for professional audiences 1 100 1 other (please specify) 1 50.0 2 respondents by size of medical writing team/department <20 medical writers 8 21.1 38 20-50 medical writers 4 44.4 9 51-100 medical writers 8 88.9 9 >100 medical writers 8 80.0 10 respondents by percentage of junior-level medical writers on team/in department <25% 9 39.1 23 25%-<50% 14 56.0 25 50%-<75% 3 33.3 9 >75% 2 22.2 9 ain order of most to least common work setting. bin order of most to least common writing focus. table 1. types of companies that have medical writing apprentice programs http://www.amwajournal.org amwajournal.org 71medical writer apprentice programs: survey results apprentice programs than those with <25% or ≥50% junior-level medical writers. what do apprentice programs look like? the 28 individuals who indicated that their companies do have an established apprentice program were asked follow-up questions to better understand key elements of their training programs. twenty-seven of the 28 individuals responded to these follow-up questions. goals and reasons for apprentice programs the primary goal of the majority (74%) of apprentice programs was to ensure medical writers have the context and skills needed to perform the role in the current landscape. the most common secondary goal was to expand the medical writing talent pool (41%) (table 2). in the follow-up interviews, the 8 respondents who agreed to participate were asked what unmet needs prompted their organizations to start an apprentice program. the majority of the interviewees were prompted to start an apprentice program because they recognized the challenges of finding experienced medical writers in today’s environment. interviewees also noted the desire to gain additional medical writers and to hopefully retain new talent by providing them with the tools and knowledge to succeed. by developing an apprentice program within their organizations, several interviewees were looking for gains in productivity and an overall increase of job satisfaction within their medical writing teams. overall, the interviewees found the programs very positive in helping to resolve their unmet needs. training styles and content in apprentice programs according to survey respondents, the most common core topics included in existing apprentice programs were document-specific knowledge (85%) and general writing skills (81%). other core topics included analytical skills, technical aptitude, leadership/soft skills, and drug development knowledge (figure 3). most of the respondents indicated that their apprentice programs utilized a team training approach rather than an table 2. primary and secondary goals of medical writing apprentice programs goals number (%) who selected this as primary goal (n = 27) number (%) who selected this as secondary goal (n = 27) n % n % ensure writers have the context and skills needed to perform the role in the current landscape. 20 74 6 22 expand the medical writer talent pool. 6 22 11 41 support and champion the medical writing industry. 0 0 4 15 development opportunities requested by writers. 0 0 4 15 other 1 4 2 7 figure 3. percentage of apprentice programs that offer specified core training topics. ≥ http://www.amwajournal.org amwajournal.org 72medical writer apprentice programs: survey results individual trainer (81%), with a mix of shadowing/coaching (93%), lecture-style presentations (85%), and self-learning (81%). training was generally provided by other medical writers (85%) and/or medical writing managers (70%). based on the responses from the 8 interviewees, most apprentice programs offered a theoretical learning component (eg, classroom learning, self-serve online modules, workbooks) and a practical hands-on learning component (eg, pairing with senior writers as trainers/mentors, coaching sessions). these programs typically start the apprentice on authoring simpler document types and progress to more complicated documents as they learn. the apprentices typically receive feedback on performance and evaluation from clients, mentors, and management. structure and duration of apprentice programs there was a mix of time-based (26%; apprentices must complete the program in a specified amount of time), competency-based (37%; apprentices work at their own pace, but must demonstrate a certain skill level to progress), hybrid (33%; apprentices must meet time and skill requirements to progress), and other (4%) structures. the majority (67%) of program durations ranged from 6 months to 2 years (figure 4). there was a mix of how frequently new apprentices were onboarded into programs (ie, on a rolling basis, as a cohort) (figure 5). twenty-three of the 27 respondents (85.2%) indicated that program participants were brought on as regular company employees; the remaining 4 respondents indicated that participants who successfully completed the program were subsequently hired into the company as regular company employees or were offered a formal recommendation into a permanent role. notably, 63% of respondents whose organizations already have an established apprentice program thought it would be useful to have a standard framework in order to further develop their program (figure 6). what about companies who do not have an apprentice program? of the 66 respondents to the question, “does your company have an established apprentice or training program,” 58% responded “no.” figure 4. duration of apprentice programs. figure 5. frequency of onboarding new apprentices. figure 6. would a standard framework for an apprentice program be useful? http://www.amwajournal.org amwajournal.org 73medical writer apprentice programs: survey results the 38 respondents who indicated that their companies do not have an established apprentice program were asked follow-up questions to better understand why their companies did not have programs. of these 38 respondents, 33 or 34 responded to each follow-up question. when asked why they do not have an apprentice program, more than half (61%) said they lack the resources to provide training, and 46% said they have no to very few junior-level medical writers to train at their organization. however, 21% said their organization is planning to implement an apprentice/trainee program within the next 2 years. most respondents (82%) who did not have an established apprentice/trainee program thought it would be useful to have a standard framework available to aid future implementation (figure 6). summary and looking forward the objectives of the survey were to understand how many and what types of companies currently have medical writer apprentice programs; the goals, training styles, structures, and durations of existing programs; and the desire for a standard framework to help guide the development or enhancement of apprentice programs. the survey responses showed that less than half of the respondents’ companies had medical writer apprentice programs, and that cros and medical writing-specific consultancies were substantially more likely to have such programs than pharmaceutical/biotech/device companies. the primary goal of the majority of apprentice programs was to ensure medical writers have the context and skills needed to perform the role, and the most common reason for starting an apprentice program was related to challenges in finding experienced medical writers in today’s environment. many existing apprentice programs include training in document-specific knowledge and general writing skills. notably, less than two-thirds of programs include training in leadership and soft skills. in a recent survey, teams indicated that leadership and collaboration skills were the values that they perceive as medical writers’ greatest contributions. however, when medical writers were asked to identify areas in which they needed more opportunities to learn, leadership skills and collaborative skills/diplomacy were 2 of the most common focus areas.3 the survey responses suggest that existing apprentice programs vary in terms of structure, duration, and how frequently new participants are brought into programs. of the companies that do not have established apprentice programs, more than half indicated that they lack the resources to provide training, and 21% said their organization is planning to implement an apprentice program within the next 2 years. importantly, regardless of whether or not respondents’ companies already have an apprentice program, the majority of respondents felt it would be useful to have a standard framework for an apprentice program either to refine existing programs or to develop a new program. as such, and in follow up to the discussions held at the 2022 amwa executive forum,2 the amwa executives advisory council established an apprenticeship framework working group to create a standard yet flexible framework for companies to use as an adaptable resource as they develop their own apprentice programs. the creation of this framework is ongoing at the time of publication of this article. acknowledgments we thank julia forjanic-klapproth, trilogy writing and consulting, and julia cooper, parexel international, for their input into the design of the survey and the interpretation of the results, and for their review of the manuscript. we also thank susan krug, amwa executive director, who provided significant support setting up the survey and communicating to survey participants. author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. author contact: kimberly.jochman@merck.com references 1. medical writing market size, share & trends analysis report by type (clinical, regulatory), by application (medical journalism, medico marketing), by end use, by region, and segment forecasts, 20222030. grand view research, inc. published 2022. accessed march 1, 2023. https://www.grandviewresearch.com/industry-analysis/ medical-writing-market 2. mas m, worley j, diskin s, et al. amwa’s fourth medical writing executives forum: creating an apprentice program to develop the next generation of medical writers. amwa j. 2023; 38(2):61-67. 3. harris d, tyrrell c, myers a, et al, on behalf of the amwa value of medical writing working group. value of medical writing: the regulatory writer’s perspective. amwa j. 2021;36(4):152-158. http://www.amwajournal.org https://www.grandviewresearch.com/industry-analysis/medical-writing-market https://www.grandviewresearch.com/industry-analysis/medical-writing-market cover v38 n2 contents mission statement, masthead from the guest editor theme article an overview of the 2022 update of gpp guidelines theme article gpp 2022 update: an interview with dikran toroser theme article a medical writer’s guide: working on clinical research manuscripts topical feature the business of medical writing: understanding the value topical feature effective onscreen editing: new tools for an old profession science series everyday ethics freelance focus ce craft corner continuing education writing: know your clinician audience ce craft corner practical strategies for creating cme/ce content: insights conference-session report: the backbone of manuscripts: supporting your writing with storytelling conference-session report: journalistic approach to writing better abstracts conference-session report: the new normal in the medical publications sector amwa news from the president 2022 annual business meeting for amwa amwa financial report, 2021-2022 amwa’s fourth medical writing executives forum medical writers apprentice programs survey results 2023 conference preview calendar of meetings v38 n2 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 75 dia “dia 2023 global annual meeting: illuminate” june 25-29, 2023 boston, ma https://www.diaglobal.org/en/flagship/dia-2023 international society of managing and technical editors “aspire 2023: leadership, accountability, and growth” july 18-20, 2023 virtual https://www.ismte.org/event/2023globalevent editorial freelancers association “efacon 2023” august 17-19, 2023 alexandria, va https://www.the-efa.org/event/efa-conference-efacon/ asian council of science editors 9th annual meeting of the acse august 20, 2023 dubai, uae and virtual https://theacse.com/2023/ australasian medical writers association “making a difference” august 24-26, 2023 auckland, new zealand https://www.medicalwriters.org/events/ council for programs in technical & scientific communication “2023 cptsc conference” september 22-23, 2023 charleston, sc https://conference.cptsc.org/ plain language association international “connecting cultures: creating bridges with clear communication” september 27-29, 2023 buenos aires, argentina https://plainlanguagenetwork.org/conferences/2023-buenosaires-argentina/ society of clinical research associates “2023 annual conference” september 29-october 1, 2023 montreal, quebec, canada https://www.socra.org/annual-conference/2023/2023annual-conference-information/ regulatory affairs professionals society “raps convergence 2023” october 3-5, 2023 montreal, quebec, canada https://www.raps.org/events/raps-convergence-2023 national association of science writers “sciencewriters2023” october 6-10, 2023 boulder, co https://www.nasw.org/events/nasw-science-writers-nationalconference-sciwri23-annual-meeting-2023-boulder-colorado academy of communication in healthcare/international association for communication in healthcare “international conference on communication in healthcare” october 22-25, 2023 rio mar, puerto rico https://www.achonline.org/icch2023 american medical writers association amwa medical writing & communication conference october 25-28, 2023 baltimore, md https://www.amwa.org/page/conference european medical writers association “56th emwa conference” november 9-24, 2023 virtual https://www.emwa.org/conferences/future-conferences/ american public health association “apha 2023 creating the healthiest nation: overcoming social and ethical challenges” november 12-15, 2023 atlanta, ga https://www.apha.org/events-and-meetings/annual calendar of meetings http://www.amwajournal.org https://www.diaglobal.org/en/flagship/dia-2023 https://www.ismte.org/event/2023globalevent https://www.the-efa.org/event/efa-conference-efacon/ https://theacse.com/2023/ https://www.medicalwriters.org/events/ https://conference.cptsc.org/ https://plainlanguagenetwork.org/conferences/2023-buenos-aires-argentina/ https://plainlanguagenetwork.org/conferences/2023-buenos-aires-argentina/ https://www.socra.org/annual-conference/2023/2023-annual-conference-information/ https://www.socra.org/annual-conference/2023/2023-annual-conference-information/ https://www.raps.org/events/raps-convergence-2023 https://www.nasw.org/events/nasw-science-writers-national-conference-sciwri23-annual-meeting-2023-boulder-colorado https://www.nasw.org/events/nasw-science-writers-national-conference-sciwri23-annual-meeting-2023-boulder-colorado https://www.achonline.org/icch2023 https://www.amwa.org/page/conference https://www.emwa.org/conferences/future-conferences/ https://www.apha.org/events-and-meetings/annual solve common headaches when reviewing documents in microsoft 365, veeva vault, google docs and more… key integrations: trusted by: 85% of the top 25 global pharma 4 out of the top 5 cros 4 out of the top 5 medical device companies learn more: go.ideagen.com/ amwa-learn-more-pleasereview https://www.ideagen.com/solutions/document-collaboration/life-sciences-pleasereview?utm_source=amwa+journal+&utm_medium=referral&utm_term=learn-more&utm_content=amwa-journal-advert-1&utm_campaign=fy25-all-comp-plr-gen-amwa-newsletter-ad v39 n1 / 2024 ©2024 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 51 there is ample evidence across many domains that writing in plain language saves time or money or both for readers and organizations. communication in plain language is generally more effective and produces better outcomes than traditional writing. in many contexts, readers prefer plain language over traditional writing styles, and use of plain language fosters the building of trust. finally, the process of translating is usually more efficient for plain language documents. in july 2023, after many years of development, discussion, and alignment, the international organization for standardization (iso) published a standard for plain language.1 this publication makes an internationally developed and agreed-upon standard available to all people interested in the use of plain language. it is an authoritative source developed by plain language practitioners, linguists, technical writers, designers, and text creators from many different countries. the standard will help all writers (authors) to make their texts (documents, web pages, etc.) most useful for the intended audiences (readers, users). it applies to most written languages and reflects the most recent research on plain language and the experience of plain language experts. advantages of having a plain language standard we all benefit from the availability of technical standards in our everyday lives. they ensure that a plug bought in new york will fit a socket in alaska and san diego. international standards ensure that a product has the same specifications, regardless of where it is manufactured and used. standardization fosters economic activity and growth. “standards are the distilled wisdom of people with expertise in their subject matter and who know the needs of the organizations they represent – people such as manufacturers, sellers, buyers, customers, trade associations, users or regulators.”2 medical writers appreciate the usefulness of standards in the realm of drug development. the many activities of the international council for harmonisation of technical requirements for pharmaceuticals for human use (ich)3 have led to a large set of standards that cover many aspects of drug development, including the definition of requirements on content and format of clinical documents, eg, structure and content of clinical study reports ich e3 or the study protocol and investigator’s brochure in ich e6 on good clinical practice. many of these standards are subsequently transferred to company standard operating procedures and associated working instructions and hence have a direct impact on the work of medical writers. also, the plain language standard provides a whole host of advantages: interoperability: the standard fosters the mutual understanding of what constitutes plain language. it provides a basis for discussion and serves as a basis for the use of plain language in special domains. the common standard allows integration of the various components developed in specialized domains. clarity and consistency: the standard provides clear guidance on how to develop texts in plain language that are easily understood by users. this reduces ambiguity and enhances the reliability of communication. cost efficiency and compliance: the standard will help streamline the processes of writing in plain language and thereby reduce costs. both the generation of plain language texts and their efficiency can be evaluated against compliance with the guidelines, creating a useful measure for writers (authors) and readers (consumers). thomas m. schindler / lay & regulatory writing, biberach, and biontech se, mainz, germany the making of the international standard for writing in plain language iso 24495-1: its usefulness, content, and how it came into existence topical feature “all industries and sectors benefit from improved communication. readers benefit when they can understand and use information. and organizations gain improved branding, efficiency, and effectiveness of communications products. a plain language standard provides all sectors, in nearly all languages, with a set of guidelines and strategies to make information more accessible and effective.”4 http://www.amwajournal.org amwajournal.org 52the making of the international standard for writing in plain language iso 24495-1 collaboration and development: the availability of the standard facilitates collaboration among practitioners, allowing them to work in a common framework. this will accelerate development processes and exchange in the community of practitioners across languages. portability: the standard will enable the transfer of texts across different environments and languages. texts and documents developed in compliance with the standard can be more easily translated without major modifications. the content of the standard at the center of the standard is the definition of plain language. it is characterized as communication in which wording, structure, and design are so clear that intended readers can easily — find what they need, — understand what they find, and — use that information. consequently, the standard evolves around 4 principles that are elaborated on in separate subchapters: principle 1: readers get what they need (relevant)  identify the readers  identify the readers’ purpose  identify the context in which readers will read the document  select the document type or types  select content that readers need principle 2: readers can easily find what they need (findable)  structure the document for readers  use information design techniques that enable readers to find information  use headings to help readers predict what comes next  keep supplementary information separate principle 3: readers can easily understand what they find (understandable)  choose familiar words  write clear sentences  write concise sentences  write clear and concise paragraphs  consider including images and multimedia  project a respectful tone  ensure that the document is cohesive principle 4: readers can easily use the information (usable)  evaluate the document continually as it is developed  evaluate the document further with readers  continue to evaluate readers’ use of the document for each principle, detailed guidelines are presented each with a small number of examples. together with the definition of terms and 2 annexes, the standard provides comprehensive coverage of the key considerations for writing plain language texts that are useful for their audiences. availability of the standard the standards developed under the auspices of iso or any national standard body are not free. they are therefore not freely available on the internet. they must be bought from iso for a small fee; in the case of the plain language standard, the fee is 96 swiss francs (around $110). clearly, this is a comparatively small sum that could be afforded by most. if the standard is used for professional purposes, this expense is usually tax-deductible. the money that is generated by selling the standards ensures that iso remains independent of economic and political influences and can give full freedom to its communities of volunteers. charging for standards allows iso to “ensure that they are developed in an impartial environment and therefore meet the needs of all stakeholders for which the standard is relevant.”5 the making of the standard looking back, it is difficult to determine who exactly it was who came up with the idea for creating a universal definition of plain language and a standard across regions, let alone structure of the plain language standard • foreword • introduction • scope • normative references • terms and definitions • governing principles • guidelines • annex a: overview of principles and guidelines • annex b: sample checklist “plain language ensures readers can find what they need, understand it and use it. thus, plain language focuses on how successfully readers can use the document rather than on mechanical measures such as readability formulas.”1 http://www.amwajournal.org amwajournal.org 53the making of the international standard for writing in plain language iso 24495-1 finding out when and where it happened. however, the initiators and the people who over many years devoted their time and efforts to nurture the idea are still around. that said, they are usually too modest to brag about their involvement in the development of the plain language standard. to fully appreciate this achievement, it is important to understand that all the definitory and alignment work in the field of plain language has been done by volunteers who are enthusiastic plain language practitioners and advocates. there was no institutional support from academia and no monetary support from governments for this initiative. however, some northern european countries such as norway have supported the cause by sending official delegates. even so, the international plain language standard was developed by people who were prepared to spend many evenings and weekends discussing ideas and fine-tuning text proposals.6-9 it is difficult enough to develop a definition in a community of practitioners and to internationally align it. it is even more challenging to get a standard developed and adopted by the international organization of standards (iso). it’s not iso that prompts the development of a certain standard. rather, someone, usually industry or other groups of practitioners, approaches a national member organization of iso which—if they see value in the proposal—brings it into the iso system of expert groups. these groups are organized in larger groups called technical committees, or tc for short (there are about 250 tcs in iso). these groups of experts negotiate and align on all aspects of the standard.10 the strength of the iso process relies on its global scope, its representation of developing countries and consumer groups, and the principle of consensus. the latter ensures that all comments of all stakeholders are considered. experts representing national standard development organizations need to be nominated by their countries’ committee to work in an iso working group. overall, it has taken some 16 years from the first public appearances of the idea of a plain language standard in 2007 to the release of the iso standard in 2023.11 the first 7 years, until 2014, were spent developing and discussing a definition of plain language. the definition was formally adopted by the international plain language federation (iplf) in 2014. then, in 2017, the iplf set up a committee to develop a plain language standard. as is so often the case, it was the initiative of a small group of people, in this case, from the iplf, led by christopher balmford, a lawyer by training, to approach standards australia and probe their willingness to take up the topic. he cold-called the relevant person at standards australia and met with him. christopher’s enthusiasm overcame the initially profound skepticism, and he convinced standard australia to take up the topic. apparently, his cause was greatly helped by the fact that he incidentally mentioned that he and a friend had paddled a sea kayak the 150 miles from mainland australia to tasmania, island hopping on a 16-day trip. this demonstrated his tenacity, endurance, and dedication—all very much needed for bringing an idea to an adopted standard. standard australia quickly realized that a plain language standard would be more effectively developed internationally, rather than nationally, and proposed the project to iso. in 2019, iso technical committee 37 (language and terminology) approved standards australia’s initiative to develop a plain language standard globally. this was an enormous success because the standard could now be developed in alignment with all 35 national standard organizations that are members of the technical committee. subsequently, iso tc 37 set up a working group (wg 11) to do the groundwork. the working group appointed a “drafting committee” of 8 members to do the initial writing of the many drafts and to discuss the feedback from both the national standard committees and other professional organizations such as clarity, the center for plain language, plain (plain language association international), the international institute for information design, and the european parliament. the proposals of the drafting committee were then discussed and decided in the wider working group (wg 11), which comprised the delegates of the national standard bodies that had decided to become involved. christopher balmford was appointed convenor and was tasked to lead the development and to ensure that the principles of iso such as fairness, freedom of speech, equality, and consensus in all decisions were followed. the working group usually had some 30 delegates from 18 countries—from every continent except antarctica—representing about 20 languages. on a personal level, christopher, being located in australia, had to chair meetings starting at 11 pm and often continuing until 1 am so as to accommodate the different time zones of the experts around the globe. over some 4 years, there were many intense phases, particularly when revised drafts were due and when comments to drafts needed to be evaluated. often, several hundred comments needed to be read, discussed, and decided upon. each comment that had been made had to be responded to in writing! leadership, dedication, and collaboration being a global endeavor, both the working group and the drafting committee comprised a wide range of different characters, all being experts in the field, each one of them enthusiastic about the topic, but each one with a well-formed and http://www.amwajournal.org amwajournal.org 54the making of the international standard for writing in plain language iso 24495-1 well-articulated opinion. it was the task of the convenor to ensure that everybody was heard, every contribution was discussed, and, most importantly, a solution was found to which everybody could agree (in line with iso’s consensus principle). the role was also administrative, ie, calling for the meetings and, very often, writing the minutes. to successfully perform at the helm of such a diverse and lively group of experts, it takes a well-balanced, patient, and emphatic character with a detailed understanding of the topic. most helpful was christopher balmford’s ability to thoughtfully guide discussions to a fulfilling conclusion. the majority of the conceptual work was done by the drafting committee, which, during the many very intense phases, often had several meetings a week. although the composition of the drafting committee changed over time, key members who contributed over extended periods of time were annetta cheek (usa), vera gergely (hungary), angelika vaasa, (belgium), david lipscomb (usa), susan kleimann (usa), torunn reksten (norway), machiko asai (japan), rosa margarita galán vélez (mexico), and andreas baumert (germany; also, the author of this article was a member of this group for several months in 2022, substituting for andreas baumert). furthermore, editing was handled by gael spivak (canada). many of them are involved in one of the plain language organizations. although good leadership was of great importance, the development of the plain language standard was successful because of the collaborative, inclusive, sharing attitude of both the members of the drafting committee and the wg 11 over some 4 intense years! all’s well that ends well? before the standard could be finally published, it had to undergo various steps of approval and discussion in iso. one of them was approval by iso tc 37. in preparation of the final vote, all national standard bodies represented in tc 37 were given the opportunity to review and comment on the final draft. this alone took several months because the national standard bodies needed to be given enough time for their review. however, after approval by tc 37, the final standard was published in june 2023. it is now available at the iso website (see above). the iplf has also developed a detailed list of frequently asked questions about the standard.12 although the standard is adopted on international level, national standard bodies with their respective committees are working on the localization of the standard to their language and territory. the iplf offers a guideline and a checklist for all those plain language practitioners who want to engage in the adoption of the standard by their national standard body.13 building on iso plain language standard part 1, there are 2 initiatives underway that aim to expand the standard into the realm of • legal writing and drafting14 and • science writing (iso/awi 24495-3, plain language — part 3: science writing). furthermore, because iso is re-evaluating every standard in 5-year intervals, the preparations for the next update have already begun. christopher balmford has meanwhile stepped down and angelika vaasa, from the european parliament, has been appointed convenor. however, given christopher’s enthusiasm for plain language, he will continue supporting the cause. the iso plain language standard was initiated and developed by an international group of experts and enthusiasts over 4 years in a process that was based on respect and equality. the standard will help authors to write documents in which readers find what they need, understand what they find, and use that information. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: thomas.schindler@biontech.de references 1. international organization for standardization. plain language, part 1: governing principles and guidelines, iso 24495-1:2023; 2023. accessed september 23, 2023. https://www.iso.org/ standard/78907.html 2. standards. international organization for standardization. accessed january 3, 2024. https://www.iso.org/standards.html 3. ich official web site. international council for harmonisation of technical requirements for pharmaceuticals for human use. accessed january 3, 2024. https://www.ich.org/ 4. the iso plain language standard. international plain language federation. accessed december 20, 2023. https://www. iplfederation.org/iso-standard/ 5. frequently asked questions: why is there a charge for standards? international organization for standardization. accessed january 3, 2024. https://www.iso.org/footer-links/frequently-askedquestions-faqs/general-faqs.html 6. balmford c. an iso standard for plain language: the back story and the next steps. 2018;79:6-10. accessed january 3, 2024. https://www.clarity-international.org/wp-content/ uploads/2020/06/clarity_79.pdf 7. balmford c, cheek a, kleimann s, harris l, schriver k. plain language standards. a way forward. the clarity journal christopher balmford http://www.amwajournal.org https://www.iso.org/standard/78907.html https://www.iso.org/standard/78907.html https://www.iso.org/standards.html https://www.ich.org/ https://www.iplfederation.org/iso-standard/ https://www.iplfederation.org/iso-standard/ https://www.iso.org/footer-links/frequently-asked-questions-faqs/general-faqs.html https://www.iso.org/footer-links/frequently-asked-questions-faqs/general-faqs.html https://www.clarity-international.org/wp-content/uploads/2020/06/clarity_79.pdf https://www.clarity-international.org/wp-content/uploads/2020/06/clarity_79.pdf amwajournal.org 55the making of the international standard for writing in plain language iso 24495-1 2018;79:11-16. accessed january 3, 2024. https://www.clarityinternational.org/wp-content/uploads/2020/06/clarity_79.pdf 8. balmford c. an iso plain language standard. international plain language federation. published september 7, 2020. accessed january 3, 2024. https://www.iplfederation.org/an-iso-plainlanguage-standard/ 9. balmford c. a language-neutral plain language standard – a tool for us all. plain ejournal 2021;3(2):6-7. accessed january 3, 2024. https://plainlanguagenetwork.org/wp-content/uploads/2022/08/ pl_2021_e-journal_vol3_no2.pdf 10. developing standards: key principles in iso standard development. international organization for standardization. accessed january 3, 2024. https://www.iso.org/developingstandards.html 11. international plain language federation. timeline of developing the iso plain language standard. googledocs. accessed january 3, 2024. https://docs.google.com/document/d/10vfmi55yxnikmc jwp9nidtdoplcfxx5ryevf4zphzjg/edit 12. complete list of faqs. international plain language federation. accessed january 3, 2024. https://www.iplfederation.org/1163-2/ 13. adopting and localizing the standard. international plain language federation. accessed january 3, 2024. https://www. iplfederation.org/adopting-and-localizing-the-standard/ 14. international organization for standardization. plain language, part 2: legal writing and drafting, iso/awi 24495-2. accessed january 3, 2024. https://www.iso.org/standard/85774.html www.amwa.org/knowledge_builders knowledge builders build your knowledge on a specific medical communication topic through a variety of elements designed to create an engaging educational experience. listen to a narrated slide set engage in exercises access the handout review the reading list note what you learned explore amwa online learning and get ready to l.e.a.r.n. http://www.amwajournal.org https://www.clarity-international.org/wp-content/uploads/2020/06/clarity_79.pdf https://www.clarity-international.org/wp-content/uploads/2020/06/clarity_79.pdf https://www.iplfederation.org/an-iso-plain-language-standard/ https://www.iplfederation.org/an-iso-plain-language-standard/ https://plainlanguagenetwork.org/wp-content/uploads/2022/08/pl_2021_e-journal_vol3_no2.pdf https://plainlanguagenetwork.org/wp-content/uploads/2022/08/pl_2021_e-journal_vol3_no2.pdf https://www.iso.org/developing-standards.html https://www.iso.org/developing-standards.html https://docs.google.com/document/d/10vfmi55yxnikmcjwp9nidtdoplcfxx5ryevf4zphzjg/edit https://docs.google.com/document/d/10vfmi55yxnikmcjwp9nidtdoplcfxx5ryevf4zphzjg/edit https://www.iplfederation.org/1163-2/ https://www.iplfederation.org/adopting-and-localizing-the-standard/ https://www.iplfederation.org/adopting-and-localizing-the-standard/ https://www.iso.org/standard/85774.html american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. v38 n4 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 10 abstract eating disorders are a group of severe medical conditions that center around energy intake and sometimes body dissatisfaction. despite their severity, eating disorders are often viewed negatively by both lay individuals and health professionals. this stigmatization is the result of inaccurate and exaggerated information about these illnesses. as health educators, medical writers are positioned to challenge and change these stigmas by creating and distributing accurate information about eating disorders. this article provides medical writers with foundational knowledge about eating disorders and background information on their stigmatization and offers suggestions for how to write about these conditions to reduce current stigmas and improve understanding of eating disorders. eating disorders in health communication health content creators construct health narratives by determining what information gets conveyed and omitted as well as the style and tone of that information. medical writers, therefore, educate and influence people’s attitudes toward medical conditions. these attitudes toward medical conditions can influence a variety of issues, including health research funding, health policy decisions and insurance coverage, support for individuals during medical treatment, and peer acceptance of individuals with certain medical conditions. despite the substantial responsibility health communicators have for creating accurate health narratives, online health information is often inaccurate and written by nonexperts.1 this lack of credibility and accuracy in health content creation is concerning because the lay public and health professionals rely on and trust this information to educate themselves.2,3 misleading health information also influences how people think and feel about individuals with medical conditions.4-6 information about eating disorders has been particularly inaccurate, omissive, and exaggerated in health communication, which has resulted in ongoing stigmatization of these illnesses.4-6 medical writers are well positioned to change this narrative by interpreting eating disorders research for nonexperts, yet information articles on eating disorders have largely been absent in medical communication. this absence may have contributed to the negative attitudes lay individuals and health professionals hold about these illnesses.4-6 the pervasiveness of stigmas around eating disorders makes now a good time for medical writers to more deeply understand these medical conditions in order to reframe the narrative and reform attitudes toward them by creating informed, nonjudgmental, and accessible content. eating behavior healthy eating eating behavior exists on a spectrum, with healthy eating on the far left (figure 1). the us government defines healthy eating as the daily consumption of a variety of nutritious foods and drinks with mindfulness for overeating or undereating.7 fulfilling your body’s homeostatic needs is, therefore, one component of healthy eating. a second component of healthy eating involves a person’s relationship with food.8 enjoying the foods you eat, avoiding food valuation (eg, labeling foods as forbidden), and having a flexible diet are additional aspects of healthy eating. melinda d. karth, ms, ma / phd candidate in neuroscience, purdue university, west lafayette, in destigmatizing eating disorders with medical writing science series figure 1. the eating behavior spectrum. healthy eating is typically defined as fulfilling the body’s homeostatic needs while maintaining a flexible diet. the transition from healthy eating to disordered eating is not clearly defined and can occur when a person’s eating behavior does not fulfill their body’s homeostatic needs (eg, restrictive or overeating); disordered eating also occurs when an individual experiences guilt or shame for eating. eating disorders are extreme versions of disordered eating and are identifiable by diagnostic clinical criteria; eating disorders have a severe, lasting impact on the body and brain (eg, heart and gastrointestinal irregularities). healthy eating disordered eating eating disorder http://www.amwajournal.org amwajournal.org 11destigmatizing eating disorders with medical writing disordered eating to the right of healthy eating on the eating behavior spectrum is disordered eating. healthy eating becomes disordered when a person engages in one or more of the following behaviors: restricting food, limiting specific foods, eating beyond satiation, experiencing guilt after eating, adhering to an inflexible diet, and/or experiencing nervousness when eating in public.9 under this definition, many accepted eating habits (eg, a low-carb diet) can be considered disordered eating. disordered eating is not necessarily harmful but becomes a cause for concern when it impairs a person’s physical health and life quality. addressing disordered eating is important because if left untreated, it could progress into an eating disorder.10 eating disorders eating disorders are extreme versions of disordered eating and are diagnosable by clinical criteria. anorexia nervosa (an): individuals must restrict their daily energy intake in ways that interfere with their body’s appropriate developmental trajectory.11 additionally, individuals must have an intense fear of weight gain, disturbed body perception, and denial of the severity of their low weight. bulimia nervosa (bn): for at least once a week for 3 months, individuals must engage in recurrent binge eating episodes.11 a food binge is defined as uncontrollably eating an atypically large amount of food during a short period of time. body disturbance and compensatory behaviors to prevent weight gain (eg, vomiting) must also occur. binge eating disorder (bed): for at least once a week for 3 months, individuals must engage in recurrent binge eating episodes.12 a binge is defined as uncontrollably eating an atypically large amount of food during a short period of time. eating until uncomfortably full and distress about binge eating behavior might also be present. avoidant restrictive food intake disorder (arfid): lack of interest in food that results in nutritional and energy deficits.13 no body image disturbance should be present, and restrictive eating cannot be attributed to a separate medical condition. pica: persistent eating of nonedible substances (eg, soil, paper, or chalk) for at least 1 month. these items cannot be culturally supported.14 orthorexia: not officially recognized as an eating disorder by the american psychiatric association but acknowledged as an eating disorder by clinicians and the public.15 involves an obsession with healthy eating that impairs an individual’s well-being. subclinical: individuals who do not meet all necessary criteria to be diagnosed with an eating disorder yet demonstrate extreme levels of disordered eating have a subclinical eating disorder. subclinical eating disorders can be damaging to a person’s health and well-being, despite not being officially recognized by the american psychiatric association. the point prevalence for eating disorders in men and women across eating disorder subtypes has been estimated at 8.8% for adults and 5.7% for adolescents, with women having a higher lifetime prevalence compared with men (8.4% verses 2.2%).16 in children (ie, ages 9 and 10), the lifetime prevalence for eating disorders across eating disorder subtypes has been estimated at 10%.17 historically, there is the misconception that eating disorders predominantly occur in white, heterosexual, cisgender individuals.18 however, emerging research shows that native american/ alaska native women and black women are as likely as white women to meet criteria for an eating disorder across subtypes, with these populations more likely to develop bed than white women. similarly, lgbtqia+ populations are at elevated risk for developing eating disorders and often have higher rates of eating disorder behaviors across subtypes compared with cisgender and/or heterosexual individuals.19 these estimates across populations, however, could be low and inaccurate, as eating disorders go largely undetected by medical professionals for people of all ages and groups.16,17 one reason for the underdiagnosis of eating disorders across populations could be the normalization of disordered eating in diet culture. eating behavior communication diet culture and weight loss definitions of eating behavior can be fluid and vague and, therefore, are often inconsistent within health communication. an example of this fluidity is diet culture.20 within diet culture, certain values are attached to different foods and lifestyle practices (eg, celery is a good food). these beliefs about food values and lifestyle practices are then accepted and ritualistically followed by people to achieve thinness, which is equated with health, morality, and increased social status in diet culture.20 because diet culture limits what a person can eat and fixates on weight loss, its practices can be considered disordered eating. dieting, however, is rarely considered disordered eating and has become normalized as a type of http://www.amwajournal.org amwajournal.org 12destigmatizing eating disorders with medical writing healthy eating through diet culture communication.20 normalizing disordered eating minimizes the seriousness of eating disorders—it also influences how people think and feel about food, how they eat, and how they relate to their bodies.20 eating disorder stigmas the normalization of eating disorder behavior (eg, food restriction) in diet culture has contributed to stigmatization about eating disorders.21 the most prevalent stigmas about eating disorders include personal responsibility for illness (eg, people with eating disorders are vain), attention-seeking (eg, people with eating disorders are not truly sick), and weakness (eg, people with binge-type eating disorders are too lazy and/or weak to lose weight through diet and exercise).22 consequently, people with eating disorders are often blamed for their illness and might internalize this self-blame.4-6,23 internalizing this self-blame might lower self-esteem, hope, and empowerment during treatment for people with eating disorders, which could prolong illness and decrease quality of life.24 for example, women diagnosed with an who feel stigmatized for their eating disorder (ie, personal responsibility) have a longer duration of illness, lower self-esteem, and more severe eating disorder symptoms compared with women who feel less stigmatized for their eating disorder.20 stigmatization about eating disorders can also foster negative reactions toward these illnesses in medical spheres, leading to the underdiagnosis of eating disorders.6,23 using neuroscience to challenge eating disorder stigmas destigmatizing eating disorders with neuroscience eating disorders have a weak presence in medical communication, despite these illnesses involving and impacting nearly every organ in the body.25 one reason for the weak presence of eating disorders in medical communication could be that these disorders are not considered to be serious medical conditions.21-24 unlike other illnesses, few pharmaceuticals have been effective in reducing symptoms; instead, treatments have centered around psychotherapy and behavioral therapy.26 emphasis on therapy in eating disorders treatment might be perpetuating the belief that these illnesses are solely psychological in nature. the omission of eating disorders from medical communication, however, needs to change, because medical communicators have a responsibility to accurately inform the public and health professionals about the complexities of medical conditions. writing about the brain’s role in eating disorder signs and symptoms is one way medical communicators could reduce eating disorder stigmas within the public sphere and among health professionals. research has demonstrated that people judge arguments supported by neuroscience information as more alluring and of higher quality than arguments supported by information from other sciences (eg, social science).27 for example, when asked to judge the quality of several scientific arguments, university students rated arguments supported with neuroscience information (eg, brain image) as superior to the same arguments without neuroscience information. research also shows that enhancing discussions about eating disorders with biological information, rather than strictly sociocultural information, improves people’s attitudes toward these illnesses.28,29 consequently, including neuroscience information in communication about eating disorders could improve understandings of these illnesses and potentially reduce their stigmatization. the brain’s role in eating disorder signs and symptoms acknowledging the brain’s role in eating disorder signs and symptoms (eg, restrictive eating) in medical communication could help destigmatize these illnesses by deemphasizing personal responsibility for eating disorder behavior. for example, research shows that atypically high levels of brain serotonin could contribute to an signs and symptoms (eg, restrictive eating, anxiety, and cognitive inflexibility), whereas atypically low levels of brain serotonin could explain bn and bed signs and symptoms (eg, compulsivity, impulsivity, and binge eating).30 based on this evidence, selective serotonin reuptake inhibitors have been used with limited effectiveness in eating disorder treatments to rebalance serotonin and reduce symptoms associated with eating disorders (eg, depression).26 whether serotonin imbalances are present before eating disorder onset (eg, the result of genetic variants) or if serotonin imbalances emerge in response to disordered eating behavior (eg, starvation or excessive carbohydrate intake), however, is unclear. acknowledging how the brain constructs body image during an active eating disorder might also explain signs and symptoms of these illnesses. body image is a complex concept describing how we perceive and feel about our bodies. this construct, which we create using our perceptions of and our feelings toward our bodies, influences the third-person image of ourselves we keep for self-reference in our long-term memory.31 consequently, our internal body construct might not accurately represent how we appear to others. nonetheless, our brains work to make this construct as accurate as possible by updating it daily with current sensory information (eg, seeing our reflection). these daily updates to our body construct explain how our mental self-representations change as our weight fluctuates. the brains of people with an, however, might not update http://www.amwajournal.org amwajournal.org 13destigmatizing eating disorders with medical writing the body construct following weight changes because of disruptions in short-term memory processing.31 these neurological disruptions to body construct updates in people with an could explain why severely underweight people with an insist that they are overweight. potential causes for these processing disruptions include, but are not limited to, stress and social influence (eg, media images of idealized body types).32 it is unclear, though, whether disruptions in body construct processing are present before an onset or if they emerge in response to an illness. additionally, people with an have reduced communication (ie, connectivity) between brain regions responsible for estimating body size and shape (eg, extrastriate and fusiform body areas).33 as a result, these individuals assess their body dimensions erroneously. body image therapy has shown to increase communication between these brain regions, resulting in more accurate estimates of body dimensions in people diagnosed with an.34 dysfunctions in gut-brain interactions might also contribute to eating disorder signs and symptoms.35-37 the gut communicates information to the brain that influences not only what we eat but also our behavior and how we feel. disorders of gut-brain interactions (dgbis) (eg, dyspepsia) are common among people with arfid, possibly because gastrointestinal discomfort contributes to food avoidance.35 in these cases, an eating disorder likely develops in response to a dgbi, and treating the dgbi could reduce eating disorder signs and symptoms. dysbiosis also plays a role in eating disorder signs and symptoms. in an, certain bacteria imbalances in the gut microbiome could contribute to the reduced appetite, depression, anxiety, and challenges with weight gain associated with this illness.36,37 for example, previous research shows that germ-free mice that receive fecal microbes from women with an have reduced food intake, difficulties gaining weight, and increased anxiety-like and compulsive behavior compared with control mice.38 how dysbiosis in an contributes to these outcomes, however, is unclear. increased gut permeability during an active eating disorder might also alter the immune system in ways that contribute to eating disorder pathology (eg, cytokines decreasing appetite).37 it is unclear, though, if atypical gut composition and/or permeability develops prior to and/or during an active eating disorder. discussion the absence of eating disorders coverage in medical writing has potentially contributed to ongoing misinformation about and stigmatization of these conditions in public and health professional contexts.4-6 reducing these stigmas and improving eating disorders education in medical settings is important because the eating disorder recovery process requires a team of health professionals (eg, physicians, dieticians, and psychologists). professionals working on an eating disorder treatment team, however, often lack specialized knowledge in eating disorders, which can slow communication between team members and interfere with treatment decisions.39,40 medical writers, therefore, could play an integral role in facilitating communication within eating disorder treatment teams by providing clear and accurate educational information about eating disorders. effective communication among treatment team members is crucial for a patient’s recovery; the longer an eating disorder persists, the more treatment-resistant it becomes, and the more it damages the brain and body (eg, heart and gastrointestinal conditions). educational content about eating disorders for health professionals could also help prevent these illnesses.41,42 physicians often overlook warning signs of an eating disorder, particularly in children and athletes, because of miseducation about these disorders and/or not taking these illnesses seriously.43,44 acknowledging signs of an eating disorder in children is important because eating disorders increase injury susceptibility and impact growth, brain development, and immune response. physicians, therefore, need a more comprehensive understanding of eating disorders and disordered eating, specifically early warning signs (eg, lanugo body hair growth), common medical complications with eating disorders (eg, slow heart rate), biochemical markers of eating disorders (eg, low potassium levels), how to safely stabilize a patient with a chronic eating disorder, and how to define eating disorder recovery. finally, medical writers can help destigmatize eating disorders in the public sphere by interpreting emerging research about these illnesses for lay audiences. important topics to write about include the underlying biology of eating disorders, emerging treatments, population-specific eating disorders (eg, different genders and ages), health consequences of eating disorders, obscure eating disorders (eg, arfid), and recognizing subclinical eating disorder behavior (eg, inflexible eating). a challenge for medical writers communicating information about eating disorders to a nonexpert audience will be to acknowledge the limitations of the available information while maintaining credibility and authority. to accomplish these tasks, it will be essential for medical writers to dispel previous misconceptions about eating disorders and embrace the complexities of the evolving science. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: melindadkarth@gmail.com http://www.amwajournal.org amwajournal.org 14destigmatizing eating disorders with medical writing references 1. crocco ag, villasis-keever m, jadad ar. analysis of cases of harm associated with use of health information on the internet. jama. 2002;287(21):2869-2871. doi:10.1001/jama.287.21.2869 2. bennett nl, casebeer ll, kristofco r, collins bc. family physicians’ information seeking behaviors: a survey comparison with other specialties. bmc med inform decis mak. 2005;5(1):9. doi:10.1186/1472-6947-5-9 3. cline rjw, haynes km. consumer health information seeking on the internet: the state of the art. health educ res. 2001;16(6):671692. doi:10.1093/her/16.6.671 4. o’connor c, mcnamara n, o’hara l, mcnicholas f. eating disorder literacy and stigmatizing attitudes towards anorexia, bulimia, and binge eating disorder among adolescents. advances in eating disorders: theory, research, and practice. 2016;4(2):125140. doi:10.1080/21662630.2015.1129635 5. blodgett salafia eh, jones me, haugen ec, schaefer mk. perceptions of the causes of eating disorders: a comparison of individuals with and without eating disorders. j eat disord. 2015;3(1):32. doi:10.1186/s40337-015-0069-8 6. thompson-brenner h, satir da, franko dl, herzog db. clinician reactions to patients with eating disorders: a review of the literature. psychiat serv. 2012;63(1):73-78. doi:10.1176/appi.ps.201100050 7. eat healthy. us department of health and human services. content updated on july 14, 2022. accessed february 27, 2023. https://health.gov/myhealthfinder/health-conditions/diabetes/ eat-healthy 8. falk lw, sobal j, bisogni ca, connors m, devine cm. managing healthy eating: definitions, classifications, and strategies. health educ behav. 2001;28(4):425-429. doi:10.1177/109019810102800405 9. dos santos alvarenga m, scagliusi fb, philippi st. development and validity of the disordered eating attitude scale (deas). percept mot skills. 2010;110(2):379-395. doi:10.2466/ pms.110.2.379-395 10. neumark-sztainer d, wall m, guo j, story m, haines j, 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doi:10.1002/eat.20507 29. wingfield n, kelly n, serdar k, shivy va, mazzeo se. college students’ perceptions of individuals with anorexia and bulimia nervosa. int j eat disord. 2011;44(4):369-375. doi:10.1002/ eat.20824 30. steiger h. eating disorders and the serotonin connection: state, trait, and developmental effects. j psychiatry neurosci. 2004;29(1):20-29. 31. lander r, heled e, gur e. executive functioning and spatial processing in anorexia nervosa: an experimental study and its significance for the allocentric lock theory. eat weight disord. 2020;25(4):1039-1047. doi:10.1007/s40519-019-00728-2 32. riva g. neuroscience and eating disorders: the allocentric lock hypothesis. med hypotheses. 2012;78(2):254-257. doi:10.1016/j. mehy.2011.10.039 33. suchan b, bauser ds, busch m, et al. reduced connectivity between the left fusiform body area and the extrastriate body area in anorexia nervosa is associated with body image distortion. behavioral brain research. 2013;241:80-85. doi:10.1016/j. bbr.2012.12.002 34. vocks s, busch m, schulte d, grönermeyer d, herpertz s, suchan b. effects of body image therapy on the activation of the extrastriate body area in anorexia nervosa: an fmri study. psychiatry res neuroimaging. 2010;183(2):114-118. doi:10.1016/j. pscychresns.2010.05.011 35. wiklund ca, rania m, kuja-hallkola r, thornton lm, bulik cm. http://www.amwajournal.org https://jamanetwork.com/journals/jama/fullarticle/194988 https://bmcmedinformdecismak.biomedcentral.com/articles/10.1186/1472-6947-5-9 https://pubmed.ncbi.nlm.nih.gov/11780707/ https://health.gov/myhealthfinder/health-conditions/diabetes/eat-healthy https://health.gov/myhealthfinder/health-conditions/diabetes/eat-healthy http://www.aafp.org/afp/2015/0101/p46.html http://www.aafp.org/afp/2015/0101/p46.html https://doi.org/10.1186/s40337-020-00327-y https://doi.org/10.1186/s40337-020-00327-y amwajournal.org 15destigmatizing eating disorders with medical writing 35. wiklund ca, rania m, kuja-hallkola r, thornton lm, bulik cm. evaluating disorders of gut-brain interaction in eating disorders. int j eat disord. 2021;54(6):925-935. doi:10.1002/eat.23527 36. lam yy, maguire s, palacios t, caterson id. are the gut bacteria telling us to eat or not to eat? reviewing the role of gut microbiota in the etiology, disease progression, and treatment of eating disorders. nutrients. 2017;9(6):602. doi:10.3390/nu9060602 37. butler mj, perrini aa, eckel la. the role of the gut microbiome, immunity, and neuroinflammation in the pathophysiology of eating disorders. nutrients. 2021;13(2):500. doi:10.3390/nu13020500 38. hata t, miyata n, takaura s, et al. the gut microbiome derived from anorexia nervosa patients impairs weight gain and behavioral performance in female mice. endocrinology. 2019;160(10):2441-2452. doi:10.1210/en.2019-00408 39. seah xy, tham xc, kamaruzaman nr, yobas pk. knowledge, attitudes, and challenges of healthcare professionals managing people with eating disorders: a literature review. arch psychiatr nurs. 2017;31(1):125-136. doi:10.1016/j.apnu.2016.09.002 40. johns g, taylor b, john a, tan j. current eating disorder healthcare services – the perspectives and experiences of individuals with eating disorders, their families and health professionals: systematic review and thematic synthesis. bjpsych open. 2019;5(4):e59. doi:10.1192/bjo.2019.48 41. maguire s, li a, cunich m, maloney d. evaluating the effectiveness of an evidence-based online training program for health professionals in eating disorders. j eat disord. 2019;7(1):14. doi:10.1186/s40337-019-0243-5 42. gurney vw, halmi ka. an eating disorder curriculum for primary care providers. int j eat disord. 2001;30(2):209-212. doi:10.1002/ eat.1074 43. hornberger ll, lane ma, the committee on adolescence, et al. identification and management of eating disorders in children and adolescents. pediatrics. 2021;147(1):e2020040279. doi:10.1542/peds.2020-040279 44. greenleaf c, petrie ta, carter j, reel jj. female collegiate athletes: prevalence of eating disorders and disordered eating behaviors. j am coll health. 2009;57(5):489-496. doi:10.3200/jach.57.5.489-496 a career in medical communication: steps to success learn about the skills and attributes needed to be a successful medical communicator and discover opportunities in the field. www.amwa.org/career_steps http://www.amwajournal.org american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. v38 n1 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 24 speakers leila emery, ma senior medical editor/rti-hs diversity and inclusion advisory council, rti health solutions, research triangle park, nc joyce clark hicks, ba senior medical editor/rti-hs diversity and inclusion advisory council, rti health solutions, research triangle park, nc by rebecca moran, md medical writers are uniquely positioned to help address inequities and bias in medical research and reporting by adopting best practices for use of inclusive language. writers who embrace inclusive language strive to focus on the perspectives and voices of those who have traditionally been marginalized or stereotyped and aim to avoid expressions that exclude groups of people who have historically faced discrimination. although the inclusive language umbrella encompasses a variety of groups and people, this presentation specifically focused on inclusive language as it applies to race, ethnicity, gender identity, and sexual orientation. to aid in the audience’s understanding of these concepts, the speakers provided definitions of several key terms (table 1).1 good for science, society, and business adopting principles of inclusive language makes data stronger. it recognizes that people use different terms to self-identify based on their race, ethnicity, gender, gender identity, and/or sexual orientation. when surveys or other research tools use generalizations or stigmatizing terms, study participants might feel confused, negated, or “othered.” as a result, they may feel unable to accurately complete a survey or be unwilling to participate in the study at all. using inclusive language increases the likelihood that a diverse array of people will participate in research, which in session report inclusive language: best practices and practical applications for medical writers and editors conference table 1. definitions of key terms diversity focuses on identities that correspond to societal differences in power and privilege and therefore the marginalization of some groups based on specific attributes; involves the representation of various social identity groups race generally regarded as a means of differentiating between people by phenotypic characteristics such as skin color; it is a societal construct that has historically been used as a tool for oppression ethnicity a multifaceted component of one’s identity that can encompass the nationality, tribal affiliation, religion, language, and traditions of a particular group, among other aspects; as with race, it has been a basis for discrimination unconscious bias social stereotypes about certain groups of people that individuals form in an unconscious manner othering to view, treat, depict, and/or refer to a person or group of people as intrinsically different from or inferior to oneself using an “us versus them” mentality gender a set of sociocultural norms and expectations about behaviors and characteristics regarding what is considered “masculine” or “feminine” in a given society or context gender identity one’s innermost concept of self as male, female, neither male nor female (eg, nonbinary), a blend of genders, or no gender; how one identifies based on these characteristics (eg, gay, lesbian, bisexual, pansexual, queer) sex assigned at birth the assignment (male, female, or intersex) that a doctor or midwife uses to describe a child at birth based on anatomy and chromosomes sexual orientation emotional, romantic, and/or sexual attraction adaptation of emery and hicks1 reprinted with permission from rti. http://www.amwajournal.org amwajournal.org 25inclusive language: best practices and practical applications turn impacts health equity. it also signals to clients that you have expertise in this skill and that you (or your company) are keeping up with evolving terminology standards. how to start using inclusive language to start using inclusive language, the speakers encouraged all medical writers to ask themselves the following questions when writing or reviewing documents: is the terminology or language used relevant, accurate, inclusive, respectful, and thoughtful?2 if it does not meet all 5 criteria, hicks asked writers to consider whether it belongs in the document at all, and if so, can the language be massaged to meet these criteria? she goes on to note that “incorporating inclusive language into our work requires conscious decisions that call for conscious actions.” table 21 lists specific examples provided by the speakers of language that is generalizing and stigmatizing, as well as their recommendations for preferred alternatives. emery and hicks provided additional advice on how writers can start using inclusive language in their work, including • respecting how individuals self-identify and allowing them to select more than one race and/or ethnicity when possible. • creating an inclusive language style guide that offers alternatives to generalized terms such as “minorities” and “non-white.” • being aware of stigmatizing language such as “mixed race” or “at-risk patients.” • avoiding “othering” language by expanding race, ethnicity, and gender identity response options in surveys. • changing “other” to “a race or ethnicity not listed” or “a gender identity not listed.” • alphabetizing survey options to avoid creating a perceived hierarchy among surveyed groups. offering feedback and managing client concerns efforts to employ inclusive language are relatively new, and you may find yourself in the position of needing to offer feedback regarding it to clients, colleagues, or other writers. the speakers offer several tips on how to approach this in a thoughtful and nonjudgmental way, including: • being constructive and collegial. • approaching the interaction as a learning opportunity. • thinking about how terminology is perceived by the reader. • collaborating with your client to create an inclusive language guide for the project. • linking to appropriate resources, such as the ama manual of style 11 th edition section on inclusive language. • keeping a log of frequently used feedback to use as stock text. • customizing software (such as perfectit) to scan for keywords or phrases for use in every project. additionally, clients might be concerned about unintentionally offending others or that the language is not inclusive enough. emery advised writers to express confidence in being able to handle the client’s inclusive language concerns, to be humble, and to “recognize that you’re human, and the client is too. inclusive language practices are new to many people, and we are all co-learning.” table 2. examples of preferred terminology avoid preferred at-risk patients, at-risk youth, at-risk communities patients at risk of developing… (a specific disease, such as diabetes) communities of color at risk of developing… black patients at risk of developing… minorities, minority best practice is to name the specific group(s) being referenced minority communities communities of color historically underserved communities historically marginalized groups mixed race biracial multiracial non-white(s) best practice is to name the specific group(s) being referenced if the group is unknown, use the above alternatives for “minority communities” homosexual(s) be specific when possible (eg, “men who identify as gay”) members of the lgbtq+ community people who identify as lgbtq+ sex change gender-affirming surgery gender-affirmation surgery gender-confirmation surgery sexual preference/ lifestyle sexual orientation “preference” and “lifestyle” erroneously suggest that sexual orientation is a choice transgendered (used as an adjective) transgender (used as an adjective, eg, “a transgender patient”) adaptation of emery and hicks1 reprinted with permission from rti. definition: lgbtq+, lesbian, gay, bisexual, transgender, queer, and many other terms. http://www.amwajournal.org amwajournal.org 26inclusive language: best practices and practical applications the impact of change if emery and hicks made one concept exceedingly clear, it is this: words matter. words have the power to draw us together or rip us apart, and medical writers can help achieve a more equitable, diverse, and inclusive society by adopting the principles of inclusive language. they summarized the enormous potential impact of embracing inclusive language by sharing an eloquent sentiment that appeared in a journal editorial on racial and ethnic disparities in research: “scientists and scientific journals have the opportunity to facilitate best practices and ultimately impact racial and ethnic disparities. the written interpretations of science by a few shape the future creation of history and science for many.” rebecca moran, md, is a freelance medical writer and practicing physician in phoenix, az. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: rebecca@moranmedicalinsights.com references 1. emery l, hicks jc. inclusive language: best practices and practical applications for medical writers and editors. presented at: 2022 amwa medical writing & communication conference; november 5, 2022, denver, co. 2. perfectit. it makes sense to use sensitive language. perfectit. published september 29, 2020. accessed april 2022. https://webtest.intelligentediting.com/blog/it-makes-sense-to-use-sensitivelanguage/ common acronyms abide: accessibility, belonging, inclusion, diversity, and equity dei: diversity, equity, and inclusion edib: equity, diversity, inclusion, and belonging jedi: justice, equity, diversity, and inclusion rje: racial justice and equity amwa live webinars tools, tips, and tricks for medical communicators. www.amwa.org/events only $20 for members can’t attend a live webinar? you won’t miss out! all registrations for live webinars include access to the recorded video in amwa online learning. http://www.amwajournal.org https://web-test.intelligentediting.com/blog/it-makes-sense-to-use-sensitive-language https://web-test.intelligentediting.com/blog/it-makes-sense-to-use-sensitive-language v38 n2 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 10 amwa: thanks dikran for taking the time to speak to amwa. first, i would like to recognize the time and effort by the steering committee and authors of the gpp 2022 update. this is a major update of the guidelines since gpp3,3 which was published in 2015. the work for the latest update started in april 2019, and the article was published in september 2022, so the entire process took more than 3 years from start to finish. my first question is why there was a need for this major undertaking to update the gpp, and what are the main objectives of this update by the gpp steering committee and authors? toroser: the publication field has been moving and changing at an extraordinarily fast pace in the last few years. for example, with the emergence of various enhanced content, publications are no longer just black-and-white pieces in a journal. the covid pandemic was an incredible catalyst for many of the changes. because people were not traveling to attend scientific conferences in person, there has been a huge need for digital enhancements, such as audio and video recordings, to be accessed virtually and on demand. another important factor is that the audience for scientific publications is evolving. the audience is no longer limited to a select few who are technically minded in the same field. today’s audience includes those who are not experts in the same field, who are not experts at all, who are short of time, or who are from other parts of world. the changes in the audience and their needs are another force in shaping the changing publication field. these are among many reasons to update the gpp guidelines. the latest gpp update builds on prior iterations of gpp guidelines and reflects the latest changes and advances in the publication field. it is worth mentioning that, as with all guidelines, gpp won’t be able to provide answers to all questions at work and requires day-to-day judgment calls by publication professionals to apply the principles in specific cases. amwa: the gpp 2022 update covers a wider scope of publications. for example, in the “scope” section, the authors described research areas applicable to gpp guidelines: besides clinical research, the scope now includes translational and biomarker studies, nonclinical research, health economics, real-world evidence (rwe), and outcomes research. why should we include these additional types of research under gpp guidelines? are there differences in planning and developing publications in these research areas other than traditional clinical research? toroser: a wider scope of publications reflects the increasingly complex nature of data and research in the healthgood publication practice (gpp) 2022 update: an interview with dikran toroser qing zhou, phd, els / regeneron pharmaceuticals, inc, tarrytown, ny interview theme article dikran toroser was educated in the united kingdom and has a phd in biochemistry from newcastle university in newcastle upon tyne. he did his postdoctoral research in the united kingdom at the cambridge laboratory on genetics and then moved to the united states to work as a biochemist and researcher for the us department of agriculture (usda). he has an extensive background in scientific publications as well as medical writing. he has led scientific publication teams involved with preclinical, clinical, and mature product studies and publications. dikran is one of the founding faculty for the university of california san diego medical writing certificate and a consulting director for the program. active in professional organizations such as the american medical writers association (amwa) and international society for medical publication professionals (ismpp), dikran most recently has been involved in compiling guidelines for publication professionals, including the amwaemwa-ismpp joint position statement on the role of professional medical writers1 and gpp 2022, the latest 2022 update of good publication practice (gpp) guidelines for company-sponsored biomedical research.2 dikran toroser, phd merck, boston, ma http://www.amwajournal.org amwajournal.org 11an interview with dikran toroser care space. for example, health economics and outcomes research became more important in terms of informing unmet medical needs as well as providing valuable information on health economics relevant to policy and decision-making from a payer’s perspective. research on real-world data (rwd) or real-world evidence (rwe is another area of growing interest and importance because rwd and rwe are playing an increasing role in healthcare decisions by regulatory agencies such as the us food and drug administration (fda).4 publication professionals today find themselves managing publications arising from expanding research disciplines besides the traditional clinical research; therefore, it is helpful that the updated gpp now covers the work that we do. because of the differences in the research process and methodology, the cadence in publication activities for these additional types of research may be different from those for clinical research. for publications on complex data or analyses, there are added challenges in making the publications understandable and meaningful to the intended audience. amwa: gpp 2022 also calls out a few new publication types, notably enhanced content and plain language summaries. definitions for these new publication types are provided in supplement section a. guidelines on the planning and developing enhanced content and plain language summaries are also provided in various other sections in the supplement, from policies and procedures (section b) to specific process steps such as publication plans (section e) and publication development process (section h). why are guidelines important for enhanced content and plain language summaries? for organizations that have not routinely worked on these new publication types, what are some key considerations? toroser: the need for these new types of publications reflects the fast-changing publication field and an evolving audience. the updated gpp guidelines support the use of enhanced content (such as video, audio, or infographics) and plain language summaries to augment the publication and increase its reach. for the teams who are new to these newer publication types, they would need to collaborate with stakeholders at their organizations to incorporate good practice in day-to-day work. gpp guidelines emphasized that enhanced content and plain language summaries should be developed following the same ethical and quality principles as the main publication. it is also important to consult the journals and congresses for their policies and requirements on enhanced content and plain language summaries. amwa: the supplement of gpp 2022 was significantly expanded and reorganized. there seems an emphasis of making this updated gpp more usable to provide guidance on day-to-day work. for example, section b describes the roles of publication professionals in developing publication policies and procedures as well as sharing best practices and continued professional development. sections d through h detail various process steps in publication planning and development of individual publications, covering topics from publication steering committees to publication working groups, from publication plans to the process of individual publications. can you elaborate a bit more on the rationale behind the expansion and reorganization of the supplement? is the expanded supplement in gpp 2022 intended as a tool for team training? toroser: thanks for asking about the aspect of training, which had been brought up many times during this current gpp update. an important goal of the gpp document is to facilitate training of publication teams on best practices, both on principles and on day-to-day work processes. yes, the supplement of the gpp 2022 update was reorganized and reformatted to increase the clarity of various topics and to make the document easier to read. the supplement is a comprehensive document with a large amount of information; it will be helpful for publication teams to be familiar with the structure of the document so they can consult relevant sections to find guidance on certain topics. amwa: publication professionals need to interact with a wide range of people—eg, company teams, authors, journal editors, and patients—in these various publication process steps and activities. can you speak to the role of publication professionals, perhaps an underappreciated leadership role, in educating others and implementing the gpp? what challenges may be faced by publication professionals in adopting gpp 2022? any insights on how to overcome these challenges? toroser: the roles of publication professionals are evolving along with the evolving field. we are the gatekeepers of best publication practices in a complex and changing landscape, often faced with complex questions and ethical dilemmas. we shoulder important responsibilities of ensuring that authors meet their authorship criteria, of working with statisticians and other teams to provide data and study materials to authors, and of meeting requirements from the journals and congresses. the important roles by publication professionals are also supported by the amwa-emwa-ismpp joint position http://www.amwajournal.org amwajournal.org 12an interview with dikran toroser statement,1 which calls out the responsibility of professional medical writers in achieving quality publications in an ethical, accurate, and timely manner. publication quality suffers when these responsibilities are not met to the full stringency. from my perspective, there has been more and more appreciation of the leadership role played by publication professionals. in terms of challenges, the global nature of publications nowadays can be a challenge to navigate cultural differences. for example, authorship practice in another culture may require more nuanced considerations, including how we ask for feedback and approval from authors. this may require a good understanding of the culture and practice in a specific region to anticipate problems and come up with solutions. amwa: many amwa members are freelance writers, some of whom provide medical writing assistance to company-sponsor biomedical research publications. for freelance writers who are new to gpp guidelines, are there specific sections or aspects in gpp 2022 that they may focus on? toroser: i very much appreciate the opportunity to reach out to professional medical writers in the amwa audience, who are an extremely important part of the publication professional community. my recommendation is that freelance writers should be closely familiar with the entire gpp document, especially ethical and quality principles. i hope that the gpp guidelines become an essential reference document for all medical writers. amwa: besides publication professionals and teams, it seems that the other audiences for the updated gpp 2022 include journal editors, conference organizers, academic institutions, and the wider research community and public. have the authors received feedback from the wider audience on the gpp 2022 update? is there anything we can do to promote dissemination of gpp 2022? toroser: the gpp author group includes representation from the pharmaceutical industry, academic researchers, journal editors, and conference organizers. also, the latest gpp update underwent review by volunteers from the public before it was finalized for submission. so, feedback from a wide range of perspectives was received during both the writing phase and the review phase. gpp guidelines have already become a cornerstone for publication processes and procedures in the industry, especially at large companies. i anticipate that gpp guidelines will be more and more widely accepted by journals, congresses, and the academic research community. for example, we already built links with organizations such as the asian council of science editors in the asia-pacific region. ismpp is also collaborating with various professional organizations such as the medical affairs professional society (maps) and drug information association (dia) to discuss and disseminate the latest gpp update. amwa membership is a crucial audience for gpp. i encourage amwa members who are involved in scientific publications to get closely familiar with the gpp 2022 update. it takes continued effort to disseminate the latest gpp guidelines; we all can do our part through discussions with colleagues and stakeholders at professional development activities and in our day-to-day work. author declaration and disclosures: the interviewee (d.t.) and the author (q.z.) note no commercial associations that may pose a conflict of interest in relation to this article. the views and opinions expressed in this article are those of the interviewee and the author and do not necessarily reflect the views of their employers. author contact: qzhou.writer@gmail.com references 1. american medical writers association (amwa), european medical writers association (emwa), international society for medical publication professionals (ismpp). amwa-emwaismpp joint position statement on the role of professional medical writers. medical writing. 2017;26:7-8. 2. detora lm, toroser d, sykes a, et al. good publication practice (gpp) guidelines for company-sponsored biomedical research: 2022 update. ann intern med. 2022;175(9):1298-1304. 3. battisti wp, wager e, baltzer l, et al.; international society for medical publication professionals. good publication practice for communicating company-sponsored medical research: gpp3. ann intern med. 2015;163(6):461-464. 4. us food and drug administration. real-world evidence. published 2023. accessed 26 february 2023. https://www.fda. gov/science-research/science-and-research-special-topics/realworld-evidence http://www.amwajournal.org https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. contents v38 n2 summer 2023 3 5 10 13 22 27 28 36 39 43 47 from the guest editor publications of biomedical research: evolving landscape and constant themes › qing zhou theme articles an overview of the 2022 update of good publication practice (gpp) guidelines: a medical writer’s perspective › qing zhou good publication practice (gpp) 2022 update: an interview with dikran toroser › qing zhou a medical writer’s guide: working on clinical research manuscripts for submission to peer-reviewed medical journals › monica nicosia topical features the business of medical writing: understanding the value proposition and successful business models › joan affleck, dominic de bellis, brian bass, and jeanette m. towles effective onscreen editing: new tools for an old profession (4th ed.) › alba i. cid science series antibody-drug conjugates: understanding associated drug design and pharmacology › jason r. lewis everyday ethics the patient-physician relationship in the context of physician-targeted violence from the perspective of a medical student › kevin a. wu freelance focus jam session for seasoned freelancers › brian bass, sherri bowen, cathryn d. evans, and phyllis minick ce craft corner continuing education writing: know your clinician audience › austin ulrich practical strategies for creating cme/ce content: insights from adult learning scholarship › alexandra howson 68 28 manuscript quality plagiarize and/or repurpose content perpetuate inaccurate data and facts insert erroneous data create a disorganized inconsistent structure introduce typos and other mistakes prevention: • fact-check • research prevention: • paraphrase • cite prevention: • proofread prevention: • check for consistency • keep parallel structure prevention: • carefully copy data • perform quality control checks13 editor-in-chief michael g. baker, phd guest editor qing zhou, phd, els managing editor rachel mosher, ma section editors progress in publications qing zhou, phd, els regulatory insights jennifer bridgers, ms, mwc science series naomi bishop, md statistically speaking thomas m. schindler, phd everyday ethics julie ravo, ba, ma freelance focus ruwaida vakil, msc ce craft corner haifa kassis, md practical matters elizabeth kukielka, pharmd, ma, ms, mwc regular contributors freelance focus brian bass, mwc melissa l. bogen, els sherri bowen, ma, els lori de milto, mj cathryn d. evans gail v. flores, phd phyllis minick in the service of good writing laurie endicott thomas, ma, els conscious writing crystal r. herron, phd, els editors in memoriam lori l. alexander, mtpw, els, mwc ronald j. sanchez 2022–2023 president elise eller, phd 2022–2023 board liaison joanna pendergrass, dvm 2022–2023 staff liaison shari rager, ms, cae executive director susan krug, ms, cae graphic designer amy boches, biographics editorial office: managingeditor@amwa.org. instructions for authors available at: www.amwajournal.org. advertising: contact marketing@amwa.org or (240) 239-0940. all advertising is subject to acceptance by amwa and should be for products and services relevant to professional medical communicators. amwa is not responsible for the content of advertising and does not endorse any advertiser or its products or services. subscription: the amwa journal is published quarterly. subscription is included with amwa membership. nonmember subscriptions cost is $75 per year. contact: american medical writers association, 30 west gude drive, #525, rockville, md 20850-4347. phone: (240) 238-0940; fax: (301) 294-9006; email: amwa@amwa.org. the amwa journal is in the mla international bibliography and selectively indexed in the cumulative index to nursing and allied health literature (cinahl) print index and the cinahl database. the opinions expressed by authors contributing to the journal do not necessarily reflect the opinions of amwa or the institutions with which the authors are affiliated. the association accepts no responsibility for the opinions expressed by contributors to the journal. ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwa journal mission statement in support of the mission of the american medical writers association (amwa) and to advance the broader profession, the amwa journal publishes content that reflects the interests, concerns, and expertise of medical communicators. its purpose is to inform, inspire, and motivate medical communicators. m o re v38 n2 / 2023 conference session reports 51 the backbone of manuscripts: supporting your writing with storytelling › allie boman 53 journalistic approach to writing better abstracts › tonya scardina 55 the new normal in the medical publications sector › kathleen scogna amwa news 57 from the president › elise eller 58 2022 annual business meeting for amwa members › r. michelle sauer gehring 59 amwa annual financial report, 2021-2022 › julie phelan 61 amwa’s fourth medical writing executives forum: creating an apprentice program to develop the next generation of medical writers › marta mas, janice worley, shiri diskin, lynne munno, robin whitsell, and julia cooper 68 medical writer apprentice programs: who has them, what are they like, and do we need more? survey results from 2022 › kim jochman, rona claire grunspan, jeanette towles, rona vasey, and linda yih 74 conference preview: there's no place like home › michele w. sequeira 75 calendar of meetings contents http://www.amwajournal.org american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. think you have what it takes to join a world-leading team of medical writers? we’d love to speak with you. become a medical writing ninja visit us at www.trilogywriting.com writers@trilogywriting.com www.trilogywriting.com/trilotalk listen to our podcast available on apple podcasts, google podcasts, and spotify american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. less time navigating regulations means more time innovating. medical & technical writing medical affairs & comms pharmacovigilance clinical science & operations project management nonclinical strategy & writing cmc strategy & writing quality assurance regulatory it technology services learn more at synterex.com or � nd us on https://synterex.com/ american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. www.amwa.org/compensation_report amwa’s 2024 medical communication compensation survey contribute to the most in-depth study on compensation in the field of medical communication. participants gain exclusive access to select results! didn’t receive the invite? contact salarysurvey@amwa.org. it’s time to talk money. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. less time navigating regulations means more time innovating. medical & technical writing medical affairs & comms pharmacovigilance clinical science & operations project management nonclinical strategy & writing cmc strategy & writing quality assurance regulatory it technology services learn more at synterex.com or � nd us on american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. contents v39 n1 spring 2024 5 6 8 16 20 21 23 25 27 29 39 40 from the editor › michael g. baker conference awards 2023 harold swanberg distinguished service award › joan affleck 2023 john p. mcgovern award address › jessica steier and andrea c. love 2023 walter c. alvarez award address building trust in public health: integrating communication every step of the way › katelyn jetelina conference session reports next-level qc review and editing in medical writing › angela trenkle roads leading to approval: the right level of detail for cmc suvmissions › sidonie jones shackleton’s ghost writer: navigating the landscape of appropriately acknowledging authors › lara burgess social media continuing medical education: next steps › laura tibaquirá strategies to prevent medical writer burnout › sophie ash science series the gut microbiome–human body symbiosis: relevance of the ubiquitous microbial community on health and development, part 2 › smitha s. dutt creative writing harmonies of justice: reflections on virtue and equality › george ongoro freelance focus nourish your niche: the rewards and risks of specialized medical writing › alex howson 44 human diseases (inflammatory bowel disease (ibd), obesity, parkinson disease, covid-19, type 2 diabetes, cancer, asthma, autism) genetic changes sporadic or hereditary dna sequence changes (eg, mutations, deletions, insertions, amplifications) gut microbiome dysbiosis causes: unhealthy diet, age antibiotics, environmental pollution, internal ph changes, type of birth, social determinants effects: inflammation, leaky gut epithelium, immune system dysregulation unhealthy diet high fat, low fiber diet, alcohol consumption, pesticides in food, processed food metabolites causes: an unhealthy diet is metabolized by increased pathogenic bacteria effects: decrease in beneficial bacteria that produce antiinflammatory short chain fatty acids (scfas), polyphenols & vitamins increase in inflammatory markers epigenetic modulations causes: environmental changes, age, unhealthy diet, mutations, metabolic disturbance effects: increase in acetylation and methylation of dna cause an imbalance between cell proliferation and apoptosis disrupted gut organ axes 29 6 editor-in-chief michael g. baker, phd managing editor rachel mosher, ma section editors progress in publications qing zhou, phd, els regulatory insights jennifer bridgers, ms, mwc science series naomi bishop, md statistically speaking thomas m. schindler, phd everyday ethics julie ravo, ma freelance focus ruwaida vakil, msc ce craft corner haifa kassis, md practical matters elizabeth kukielka, pharmd, ma, ms, mwc around the career block cecilia petrus, msc technology talk kyla ross, bs, ms regular contributors freelance focus brian bass, mwc melissa l. bogen, els sherri bowen, ma, els lori de milto, mj cathryn d. evans gail v. flores, phd alex howson, phd phyllis minick in the service of good writing laurie endicott thomas, ma, els conscious writing crystal r. herron, phd, els editors in memoriam lori l. alexander, mtpw, els, mwc ronald j. sanchez 2023–2024 president r. michelle sauer, phd, els 2023–2024 board liaison qing zhou, phd, els 2023–2024 staff liaison shari rager, ms, cae executive director susan krug, ms, cae graphic designer amy boches, biographics editorial office: managingeditor@amwa.org. instructions for authors available at: www.amwajournal.org. advertising: contact marketing@amwa.org or (240) 239-0940. all advertising is subject to acceptance by amwa and should be for products and services relevant to professional medical communicators. amwa is not responsible for the content of advertising and does not endorse any advertiser or its products or services. subscription: the amwa journal is published quarterly. subscription is included with amwa membership. nonmember subscriptions cost is $75 per year. contact: american medical writers association, 9841 washingtonian blvd, suite 500-26, gaithersburg, md 20878. phone: (240) 238-0940; fax: (301) 2949006; email: amwa@amwa.org. the amwa journal is in the mla international bibliography and selectively indexed in the cumulative index to nursing and allied health literature (cinahl) print index and the cinahl database. the opinions expressed by authors contributing to the journal do not necessarily reflect the opinions of amwa or the institutions with which the authors are affiliated. the association accepts no responsibility for the opinions expressed by contributors to the journal. ©2024 american medical writers association. all rights reserved. issn 2163-5315 amwa journal mission statement in support of the mission of the american medical writers association (amwa) and to advance the broader profession, the amwa journal publishes content that reflects the interests, concerns, and expertise of medical communicators. its purpose is to inform, inspire, and motivate medical communicators. m o re v39 n1 / 2024 42 technology talk generative ai in clinical research: regulatory submissions, clinical data management, and beyond › ihab mansoor, javier garcía ortiz, and matthew rector topical features 44 using innovative tools and lean writing workflow processes to accelerate regulatory document writing › robert panek, sara fernandes, mauro meloni, gregory morehouse, and rona grunspan 51 the making of the international standard for writing in plain language iso 24495-1: its usefulness, content, and how it came into existence › thomas m. schindler 56 understanding the impact of technology on medical writing: amwa survey results from june 2023 › karen rutkowski, kenneth shapiro, and laura sheppard amwa news 60 from the president › r. michelle sauer 61 calendar of meetings contents http://www.amwajournal.org american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. v38 n4 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 7 theme article abstract over the years, multiple reports and editorials have asserted that continuing education/continuing medical education (ce/cme) that is funded by the pharmaceutical or device industry is biased in favor of the funder’s product(s). but starting in the early 2000’s, several stakeholder organizations began establishing guidance to prevent such bias, and currently there are many protections in place. in particular, the accrediting council for continuing medical education (accme), the accrediting body for all national organizations that provide ce/cme, established and continues to update specific standards to prevent bias, and all accmeaccredited organizations must comply with these and other standards to maintain their accreditation in good standing. a careful review of the literature has identified just a few studies that explore the question of bias in ce/cme, all published from 2010 – 2012. none of these studies found evidence of bias in ce/cme, and no empirical studies on the topic have since been published. thus it seems that the protections in place are working, although more rigorous and definitive research is needed. nevertheless, continued vigilance is paramount, and medical writers play an important role in providing oversight of ce/cme by ensuring that content they develop is fair and unbiased, as well as accurate and intended to promote optimal patient care. there is a widespread and persistent assumption that continuing education/continuing medical education (ce/cme) that is supported via educational grants from pharmaceutical or device companies is biased toward the supporter’s product or products. but is the assumption fair, and is there evidence to support it? what do clinician learners have to say? this article explores requirements intended to prevent industry bias in ce/cme, published research on bias in ce/ cme activities, and practical steps medical writers can take to ensure that ce/cme content is accurate and objective. current accreditation requirements for preventing commercial bias for many years there have been layers of protections to prevent commercial bias in ce/cme from various stakeholders in ce/cme. protections currently in place include codes of ethics (from the pharmaceutical researchers and manufacturers of america, the advanced medical technology association, and the american medical association),1-3 compliance guidance from the department of health and human services’ office of inspector general,4 and accreditation requirements from the accrediting council for continuing medical education (accme).5 with regard to ce/cme content, accme’s standards for integrity and independence in accredited continuing education offers the most detailed guidance.5 the accme is the accrediting body for all national organizations that provide ce/cme. it has a long history of concern about commercial influence in ce/cme. the first accme standards were released in 1992;6 major revisions were released in 2004 and again in 2020. the revisions have (among other priorities) progressively better defined and further restricted industry influence. the most current standards focus on 5 aspects of ce/cme funding, development, and delivery (table 1); the most relevant for development of ce/cme content are standards 1 and 2. eve j. wilson, phd, facehp / medical director, platformq health, needham, ma can industry-funded ce/cme be unbiased? current insights on an old question table 1. the accreditation council for continuing medical education’s standards for integrity and independence in accredited continuing medical education5 standard 1 ensure content is valid. standard 2 prevent commercial bias and marketing in continuing medical education. standard 3 identify, mitigate, and disclose relevant financial relationships. standard 4 manage commercial support appropriately. standard 5 manage ancillary activities offered in conjunction with commercial support. http://www.amwajournal.org amwajournal.org 8can industry-funded ce/cme be unbiased? the content validity standard (standard 1) holds accredited providers responsible for ensuring their education is fair and balanced and supports safe and effective patient care. standard 1 specifies that research discussed in ce/cme must “adhere to generally accepted standards of experimental design, data collection, analysis, and interpretation” and that recommendations for patient care must be “based on current science, evidence, and clinical reasoning.”5 standard 2 requires that all decisions regarding planning, delivery, and evaluation of ce/cme be made free of influence or involvement from “ineligible companies” (formerly called “commercial interests”). ineligible companies are defined as those “whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used on or by patients.” importantly, ineligible companies also cannot recommend, or even suggest, names of faculty for ce/cme programs.5 perceptions of bias among clinician learners: what does the research show? to date, numerous reports and editorials have asserted that commercial support introduces bias in ce/cme; some have even called for a total ban.7-9 but none cite empirical evidence to support bias due to commercial support—perhaps because so few studies have systematically examined the issue. a careful literature search turned up only 4 studies conducted after 2004 (when accme first released more rigorous standards) that relied specifically on feedback from clinicians participating in ce/cme. one study examined 95,000 evaluation responses across 346 ce/cme activities held in 2007 by the cleveland clinic center for continuing education.10 the analysis found that a mean of 98.4% participants responded “yes” (vs “no”) to a question about whether the activity was “satisfactorily free” of commercial bias, and a mean of 97.2% participants responded with “excellent” or “good” to the question about the degree to which the activity was free of commercial bias. when analyzed based on commercial support, activities were considered free of commercial bias by 98.5% of respondents for activities with a single support source, 98.3% of respondents for activities with multiple support sources, and 98.0% of respondents for activities with no commercial support. a second study examined evaluation responses for 213 accredited, live educational courses offered by the university of california at san francisco from 2005 to 2007.11 about 33% of courses had no commercial support; the others had varying levels of support. this study found that a median 97% of participants perceived no commercial bias (median number of participants per program was 132). moreover, no associations were observed between the degree of perceived bias and the extent or absence of commercial support. a third study looked at perceived bias in evaluations from 1,064,642 physician participants in 3,137 medscape online cme activities, of which 28% were supported by industry.12 evaluations asked whether the activity was “presented objectively and free of commercial bias,” with these answer choices: strongly agree, agree, no opinion, disagree, or strongly disagree. overall, just 0.63% of respondents disagreed or strongly disagreed with the statement; that rate was slightly higher (0.84%) for commercially supported activities and slightly lower (0.48%) for those with no commercial support. interestingly, the fourth study examined perceptions of bias in live cme programs that received no commercial support, held in 2006, 2007, and 2010.13 more than 1,500 attendees were asked whether they thought commercial support influenced content selection for the overall program and for individual lectures. from 6% to 9% responded “yes” or “somewhat” across programs; of those who rated a program as biased, about 75% also rated one or more lecture as biased. these findings speak to a nuance well beyond the scope of this article—specifically, that clinicians may perceive commercial influence as something beyond just commercial support. based on these findings, it seems fair to conclude that at least from clinicians’ point of view, commercial bias in cme is quite low and independent of commercial support. however, more—and more definitive—research is needed. in the meantime, it remains crucial to safeguard against bias. all those involved in content development, including medical writers, must be aware of that potential and work to mitigate the risk. practical steps for medical writers perhaps the 2 most important (and interrelated) concepts for medical writers to uphold, vis-à-vis the accme standards, are ensuring content validity and ensuring that content is fair and balanced. often medical writers work closely with faculty to develop cme content. a common approach is for faculty to send a set of slides that the writer then organizes, carefully fact-checks, and frequently develops further. another approach is for medical writers to craft content that faculty then review. either way, the medical writer must provide oversight to ensure the content is accurate and free from marketing messages or other commercial influence. regarding content validity, use of appropriate source material is key. sources should include peer-reviewed clinical and scientific articles, published preferably in high impact factor journals. published abstracts outlining http://www.amwajournal.org amwajournal.org 9can industry-funded ce/cme be unbiased? research to be presented at medical meetings are often peer reviewed and can serve as acceptable references. posters based off these abstracts are generally not peer reviewed, but often present the most current information available and so may require a judgment call. other valid resources include guidelines or special reports published by government sources or medical societies, or textbooks—although textbooks may not have the most current information. many medical writers like uptodate as comprehensive resource for clinical care, but it is not suitable as an original source. sources to avoid include blogs, wikipedia, or other nonscholarly websites; other ce/cme programs; ineligible companies’ websites or press releases; and of course, outdated or obsolete references. ensuring that content is fair and balanced means that, by accme’s definition, information and recommendations or emphases in ce/cme “fairly represent” and are “based on a reasonable and valid interpretation” of information available on the topic.5 the box provides a checklist to help medical writers to develop ce/cme content that is fair and balanced. conclusion there are many protections against bias in cme; prominent among them are the current accme standards. on review of published studies, these protections would seem to be working, however, more rigorous and definitive research is warranted. in the meantime, medical writers can play an important role in oversight of ce/cme by ensuring that content they develop is fair, balanced, unbiased, and accurate, with a goal of promoting safe and effective patient care. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. statements and opinions presented in this article are the author’s own and do not necessarily reflect those of current or past employers or contractors. author contact: evejwilson1@gmail.com references 1. pharmaceutical researchers and manufacturers of america (phrma). code on interactions with health care professionals. phrma; 2021. accessed august 25, 2023. https://phrma.org/-/ media/project/phrma/phrma-org/phrma-org/pdf/p-r/ phrma-code---final.pdf 2. advanced medical technology association. advamed code of ethics on interactions with u.s. health care professionals. advanced medical technology association; 2023. accessed august 25, 2023.https://www.advamed.org/wp-content/ uploads/2023/06/2023-advamed-code-of-ethics.pdf 3. ethics opinions. american medical association. https://codemedical-ethics.ama-assn.orgopinions?search=medical+education 4. department of health and human services, food and drug administration. guidance for industry: industry-supported scientific and educational activities. fed regist. 1997; 62(232):64074-64092. accessed august 25, 2023. https://www.fda. gov/media/70844/download 5. accreditation council for continuing medical education. standards for integrity and independence in accredited continuing education. 2020. accessed august 25, 2023. https:// www.accme.org/accreditation-rules/standards-for-integrityindependence-accredited-ce 6. mcmahon gt. changes to the standards for integrity and independence in continuing medical education. jama. 2021;325(18):1833-1834. doi: 10.1001/jama.2021.0213 7. fletcher sw. chairman’s summary of the conference. bermuda, 2007. in: hager m, ed. continuing education in the health professions: improving healthcare through lifelong learning. josiah macy, jr. foundation; 2008. accessed august 25, 2023. https://macyfoundation.org/assets/reports/publications/macy_ conted_1_7_08.pdf 8. the pew charitable trusts. conflict-of-interest policies for academic medical centers: recommendations for best practices. pew trusts. published december 18, 2013. accessed august 25, 2023. https://www.pewtrusts.org/en/research-and-analysis/ reports/0001/01/01/conflictsofinterest-policies-for-academicmedical-centers 9. fugh-berman a. industry-funded medical education is always promotion—an essay by adriane fugh-berman. bmj. 2021;373:n1273. doi: 10.1136/bmj.n1273 10. kawczak s, carey w, lopez r, jackman d. the effect of industry support on participants' perceptions of bias in continuing medical education. acad med. 2010;85(1):80-84. doi: 10.1097/ acm.0b013e3181c42f80 11. steinman ma, boscardin ck, aguayo l, baron rb. commercial influence and learner-perceived bias in continuing medical education. acad med. 2010;85(1):74-79. doi: 10.1097/ acm.0b013e3181c51d3f 12. ellison ja, hennekens ch, wang j, lundberg gd, sulkes d. low rates of reporting commercial bias by physicians following online continuing medical education activities. am j med. 2009;122(9):875-878. doi: 10.1016/j.amjmed.2009.02.026 13. goldfarb e, baer l, fromson ja, gorrindo t, iodice ke, birnbaum rj. attendees’ perceptions of commercial influence in noncommercially funded cme programs. j contin educ health prof. 2012;32(3):205-211. doi: 10.1002/chp.21146 ensuring ce/cme content is fair and balanced • use the best available source materials. • avoid focus on any one treatment. • give equal time to benefits and risks of treatment. • avoid brand names for agents, devices, or procedures; if it is necessary to use a brand name for one intervention, then provide brand names for all interventions. • be transparent about emerging therapies, including what clinical trial phase they are in. http://www.amwajournal.org https://phrma.org/-/media/project/phrma/phrma-org/phrma-org/pdf/p-r/phrma-code---final.pdf https://phrma.org/-/media/project/phrma/phrma-org/phrma-org/pdf/p-r/phrma-code---final.pdf https://phrma.org/-/media/project/phrma/phrma-org/phrma-org/pdf/p-r/phrma-code---final.pdf https://www.advamed.org/wp-content/uploads/2023/06/2023-advamed-code-of-ethics.pdf https://www.advamed.org/wp-content/uploads/2023/06/2023-advamed-code-of-ethics.pdf https://code-medical-ethics.ama-assn.org/opinions?search=medical+education https://code-medical-ethics.ama-assn.org/opinions?search=medical+education https://www.fda.gov/media/70844/download https://www.fda.gov/media/70844/download https://www.accme.org/accreditation-rules/standards-for-integrity-independence-accredited-ce https://www.accme.org/accreditation-rules/standards-for-integrity-independence-accredited-ce https://www.accme.org/accreditation-rules/standards-for-integrity-independence-accredited-ce https://macyfoundation.org/assets/reports/publications/macy_conted_1_7_08.pdf8 https://macyfoundation.org/assets/reports/publications/macy_conted_1_7_08.pdf8 https://www.pewtrusts.org/en/research-and-analysis/reports/0001/01/01/conflictsofinterest-policies-for-academic-medical-centers https://www.pewtrusts.org/en/research-and-analysis/reports/0001/01/01/conflictsofinterest-policies-for-academic-medical-centers https://www.pewtrusts.org/en/research-and-analysis/reports/0001/01/01/conflictsofinterest-policies-for-academic-medical-centers american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. contents v39 n3 fall 2024 4 5 9 11 16 18 21 25 28 31 from the guest editor › angela russell winnier theme articles advantages and applicability of a master class series as a training model for mid-career medical writers: our experience from the perspectives of the manager, trainer, and participants › andriana papaconstantinou, anne mcdonough, and luba binshtok the call of the open road: is medical writing right for you? › robin whitsell training the medical writers of the future using a structured entry-level program: a life sciences communications agency perspective › michelle utton-mishra, melissa k. purves, linda mascarenhas, and valerie moss medical writing and editing internships: preparing the next generation of medical communication professionals › sidonie jones technology talk is the hype real? real-life user experience of an artificial intelligence tool for clinical study report production › julia forjanic klapproth ce craft corner advance your writing skills:crafting effective multiple-choice questions for continuing education activities › heidi veillette conscious writing the essential elements of the discussion section of a research manuscript › crystal r. herron freelance focus › melissa l. bogen, cathryn d. evans, lori de milto, and alex howson q1: what advice would you give to freelance medical writers, editors, or communicators who are new to medical writing and have limited writing experience? q2: what are the top software tools for new medical writers? q3: what is the role of generative artificial intelligence in medical writing? in the service of good writing how to read (and write) a book › laurie endicott thomas 50 45 11 editor-in-chief michael g. baker, phd guest editor angela russell winnier, phd managing editor rachel mosher, ma section editors progress in publications qing zhou, phd, els regulatory insights jennifer bridgers, ms, mwc science series naomi bishop, md statistically speaking thomas m. schindler, phd everyday ethics julie ravo, ba, ma freelance focus ruwaida vakil, msc ce craft corner haifa kassis, md practical matters elizabeth kukielka, pharmd, ma, ms, mwc around the career block cecilia petrus, msc technology talk kyla ross, bs, ms regular contributors freelance focus brian g. bass, mwc melissa l. bogen, els sherri bowen, ma, els lori de milto, mj cathryn d. evans gail v. flores, phd alex howson, phd phyllis minick in the service of good writing laurie endicott thomas, ma, els conscious writing crystal r. herron, phd, els editors in memoriam lori l. alexander, mtpw, els, mwc ronald j. sanchez 2023–2024 president r. michelle sauer, phd, els 2023–2024 board liaison qing zhou, phd, els 2023–2024 staff liaison shari rager, ms, cae executive director susan krug, ms, cae graphic designer amy boches, biographics editorial office: managingeditor@amwa.org. instructions for authors available at: www.amwajournal.org. advertising: contact marketing@amwa.org or (240) 239-0940. all advertising is subject to acceptance by amwa and should be for products and services relevant to professional medical communicators. amwa is not responsible for the content of advertising and does not endorse any advertiser or its products or services. subscription: the amwa journal is published quarterly. subscription is included with amwa membership. nonmember subscriptions cost is $75 per year. contact: american medical writers association, 9841 washingtonian blvd, suite 500-26, gaithersburg, md 20878. phone: (240) 238-0940; fax: (301) 2949006; email: amwa@amwa.org. the amwa journal is in the mla international bibliography and selectively indexed in the cumulative index to nursing and allied health literature (cinahl) print index and the cinahl database. the opinions expressed by authors contributing to the journal do not necessarily reflect the opinions of amwa or the institutions with which the authors are affiliated. the association accepts no responsibility for the opinions expressed by contributors to the journal. ©2024 american medical writers association. all rights reserved. issn 2163-5315 amwa journal mission statement in support of the mission of the american medical writers association (amwa) and to advance the broader profession, the amwa journal publishes content that reflects the interests, concerns, and expertise of medical communicators. its purpose is to inform, inspire, and motivate medical communicators. m o re v39 n3 / 2024 regulatory insights 35 european union regulation on personal data protection in medical writing › tatiana revenco amwa news 40 from the president › r. michelle sauer 41 amwa annual financial report, 2022–2023 › julie phelan 43 2024 walter c. alvarez award recipient oris brawley, md › michele w. sequeira 44 2024 john p. mcgovern award recipient eliseo pérez-stable, md › r. michelle sauer 45 2024 golden apple award recipient kathy spiegel, phd, mwc › loretta bohn 46 2024 amwa president's award recipient › barbara gastel, md, mph, els(h) r. michelle sauer 47 member awards committee announces honors › loretta bohn 48 officer candidate slate for the 2024–2025 election › roshawn (shawn) watson 50 innovate, inform, and inspire: jazz up medical communication at the 2024 medical writing & communication conference › michele w. sequeira 51 sneak peek of the amwa 2024 medical communication compensation survey results › shari rager 54 calendar of meetings contents http://www.amwajournal.org v38 n2 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 3 the field of biomedical research publication has undergone significant changes in the last few years. the covid-19 pandemic catapulted forward an era of virtual scientific conferences, for which technological tools were quickly developed and established to enable the display of conference presentations and posters on digital platforms. although conferences have returned to in-person attendance, most still use a hybrid format, enabling virtual participation and on-demand access to digital conference materials. on the front of biomedical publishing by scholarly journals, there is a similar trend toward digital content beyond the traditional 2d format. many journals have embraced digital enhancements of journal articles to extend their reach to a wider audience. examples include video or audio abstracts, infographic summaries, plain language summaries, and social media posts, to name a few. tied to the evolving format and types of publications is the evolving audience of biomedical research data. in the current digital environment and with more open access available, scientific publications now reach a much wider audience all around the world. for publications of biomedical research, especially clinical studies, the readers are no longer only the clinicians and researchers in the field. they can include investors and funders of research, payors of health care, and patients and their families. in this new publication environment, medical writers often embrace the task of completing multiple deliverables for one publication, which often means shorter timelines and more complex review and approval cadence. the scope and depth of publications are increasing as well. besides the traditional phase 1 to 4 clinical studies, medical writers now also work on publications of real-world data research, health economics and outcomes research, biomarker and other translational research, and preclinical research. also, publication teams nowadays can be larger and more complex, including authors and contributors from more parties or functions (eg, academic institutions, sponsors, contract research organizations, alliance partners, and patients). with these changes, medical writers often find themselves learning new topics and collaborating with more people. are there constant themes in this backdrop of a rapidly evolving landscape? my answer is a definite “yes.” one constant theme is the need for good medical writers who can step up to the challenges and contribute to successful publications, fulfilling authors’ visions and meeting readers’ needs. a good medical writer is masterful at the art and craft of medical writing. they have solid command of scientific research principles and methodologies, they understand authors’ intent and readers’ needs, they know journals’ guidelines and requirements, and of course, they possess writing skills that deliver concise and precise prose, logical flow of information, and effective visual representation of research data. this package of knowledge and skills will always remain a core competency of any medical writer working on scientific publications, regardless of research topic or publication type. a good medical writer is also masterful at driving a project and collaborating with authors, contributors, and many other people involved in the publication process. last, a good medical writer is a lifelong learner. through continued education and professional development (eg, activities run by professional societies such as amwa, the european medical writers association, and the international society for medical publication professionals), they strive to keep up with advances and changes in the field and define and reflect on our evolving roles and responsibilities. in this special issue of the amwa journal, i reflect on the rapidly evolving landscape of biomedical publications and the constant theme of achieving medical writing excellence. two featured topics correspond with these 2 strands of thoughts. the first featured topic is the latest good publication practice (gpp) guidelines—the gpp 2022 update. first published 20 years ago, the gpp guidelines have become a cornerstone of principles and standards for publications of company-sponsored biomedical research. the latest publications of biomedical research: evolving landscape and constant themes qing zhou, phd, els / regeneron pharmaceuticals, inc, tarrytown, ny from the guest editor http://www.amwajournal.org amwajournal.org 4publications of biomedical research: evolving landscape and constant themes iteration was published in august last year. for those who are relatively new to the latest 2022 gpp guidelines, an overview article provides a summary of key updates, a quick tour of the much-expanded document, and a discussion of changes relevant to medical writers and editors. an accompanying piece on this topic is an interview with dikran toroser, a coauthor of gpp 2022, on his insights into the changing field, key updates of gpp, roles of medical writers and publication professionals, and uptake of gpp guidelines. the second featured topic is a practical guide shared by a seasoned writer, monica nicosia, for working on clinical research manuscripts for submission to peer-reviewed medical journals. this article offers perspectives, insights, and practical guidance on various aspects of working on a clinical research paper: how a medical writer contributes to the project at various process steps, the essential knowledge and skills, how to get started on a project, how to develop the first draft, how to avoid common pitfalls, and how to work with difficult people. early career writers benefit from insights from experience medical writers, and as the author recognized, “our practice and ongoing learning are critical for success.” this amwa journal issue also includes summaries of 3 publication-themed open sessions from the 2022 medical writing & communication conference. these topics—“the new normal in the medical publication sector,” “the backbone of manuscripts: supporting your writing with storytelling,” and “journalistic approach to writing better abstracts”— further add to our reflection on the evolving landscape of the field and enduring essentials of medical writing. i welcome your feedback for this special themed issue on publications. the amwa journal recently created a section “publication progress” that we hope will become a forum for sharing updates, experience, insights, and ideas for those who work in the publication field. as the section editor for “publication progress,” i encourage your contribution to the journal and look forward to continued reflection about our profession in an evolving landscape. author declaration and disclosures: the author notes no commercial conflict of interest in relation to this article. the views and opinions expressed in this article are those of the author and do not necessarily reflect the views of the author’s employer. author contact: qzhou.writer@gmail.com editor’s note: in our spring 2023 issue of amwa journal, the author of “common grantsmanship hurdles of early career clinician-scientists and how a medical writer can help” noted that they were missing grant information in their acknowledgments. the individual pdf for that article and the full issue pdf galleys were updated on 7 april 2023 in order to add this information. macro and micro: taking editing all the way ffrom measurement to meaning.save over 15% when purchasing as a package! find it now in amwa online learning www.amwa.org/online_learning ensure a clear message with credibility and clarity. macroediting helps an author speak with credibility and clarity. the process works to ensure a clear message with congruent parts, coherent information, and a unified focus. create high-quality scientific documents with the essential components of macroediting and gain the “bird’s eye view.” macroediting produce the desired effect with accuracy and intention. microediting dives into the details by requiring a close analysis of a text’s smallest building blocks: words, phrases, sentences, and paragraphs. this process makes the paper easier to read, factually and grammatically sound, and more likely to produce the desired effect on its audience. microediting http://www.amwajournal.org v39 n2 / 2024 ©2024 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org e1 theme article this session provided attendees with an overview of the elements of artificial intelligence (ai) that medical communication professionals can use in their decision-making when communicating about and with ai applications. knowing how to determine if an ai application is reliable and secure guides the professional in their assessment of applications they write about and their choice of applications they use in their practice. in turn, this ability to assess ai applications underpins professionals’ abilities to identify and apply best practices for developing and writing about ai. taken together, this understanding of how ai works, how applications are developed, and how to identify and ethically apply best practices will guide professionals in their communication about and with ai applications. ai fundamentals the field of ai emerged in the early 1940s, and one touchstone of the field, the turing test of machine intelligence (designed to determine if a machine can think like a human)1 dates to 1950. although initially considered a single field of research, in the intervening decades, researchers have split the study of ai across multiple domains involving myriad disciplines. as a result, ai is defined many ways, but 2 particularly salient definitions are (1) a machine performing a task requiring human intelligence and (2) a machine replicating human intelligence. both definitions, like the turing test, evaluate ai in the context of human intelligence (including behavior); however, the ai applications that have been developed thus far lack human traits, such as empathy and creativity, and human reasoning in the frameworks of ethics and complex strategy. machine learning machine learning (ml) underpins many of the ai applications that medical communicators will communicate about and with. patient triage, hospital management, and imaging applications approved by the us food and drug administration use ml. what makes ml applications different from traditional software applications is that most ml does not use explicit or rule-based programming. in explicit programming, a program gives the computer specific commands or lines of code, that is, the function. ml uses statistical and mathematical modeling and incredible volumes of data to learn relationships between variables, that is, it determines the function. the model learns and refines itself as it ingests and processes data. some common models used in ml include linear regression, logistic regression, bayesian algorithms, and decision trees.2 deep learning and generative pretrained transformer applications deep learning (dl), a type of ml that uses an artificial neural network modeled on the human brain and designed to emulate human processing, uses layers of connected nodes that process information and pass the transformed data up to the next layer. it learns from itself and can create new features on its own. it can learn nonlinear, high-dimensional relationships from data that are not just unstructured but multimodal. throw it all in the mix—imaging, biometrics, audio, visual, and time series data. dl applications include target validation, identification of prognostic biomarkers, analysis of digital pathology ct data, and generative pretrained transformer applications (gpts). j. kelly byram, ms, mba, els / founder and ceo, duke city consulting, llc, albuquerque, nm communicating about and with artificial intelligence applications * this article is based on the presentation communicating about and with artificial intelligence applications by j. kelly byram, ms, mba, els, at amwa’s 2023 medical writing & communication conference. editor’s note developments in artificial intelligence (ai) will continue to be of critical importance to medical communicators for the foreseeable future. accordingly, amwa journal expects to continue to feature ai-related articles in upcoming issues. given how rapidly advancements are occurring in ai as they relate to medical communication, we are striving to be as timely as possible in bringing relevant articles to you. in this spirit, we are supplementing the summer 2024 digital revolution theme issue with a timely article titled ‘communicating about and with artificial intelligence applications’ by j. kelly byram, based on a presentation made by the author at the most recent amwa medical writing & communication conference. http://www.amwajournal.org amwajournal.org e2communicating about and with artificial intelligence applications because dl creates its own algorithms, the models and applications created by dl can lack transparency. this black box effect enhances a distrust of ai in many population segments, and 60% of americans overall indicated discomfort with the use of ai in their care.3 it can help to keep this discomfort front of mind when writing for lay audiences. state of the science we typically divide ai into 2 categories: weak and strong (figure 1). weak ai is what we have today—systems or machines that have learned how to perform specific tasks in a way similar to how a human would perform the task. some systems display human intelligence; that is, they have the ability to learn and solve some types of problems, but not all.4 although today the mention of ai elicits discussion of gpt applications such as chatgpt, ai has been a part of the knowledge professional’s workflow for so long that it has been taken for granted as the power behind search engines, spam filters, and smart assistants such as siri and alexa. strong ai, or sentience, is the flexible intelligence that can flit from one type of task to another and has advanced reasoning capabilities. hal from 2001: a space odyssey and skynet from terminator usually come to mind when discussing this type of ai. unlike siri and alexa, references to hal and skynet usually evoke fear and dystopian angst. depending on one’s point of view, strong ai is either an aspirational goal or an existential threat. ai in health care three subfields of ai more commonly leveraged in health care research and practice include ml, dl, and large language models (llms) as gpt applications. these applications segment images to assist in the identification and segmentation of lesions, identify promising molecules and guide drug development, determine dosage, and assist in genomics and precision medicine, public epidemiology, emergency department triage, and hospital management.5 some of these models are standalone software packages, others are slick software-as-a-service applications integrated with electronic health records. communicating about and with ai applications medical writers and editors who work with ai development teams have been writing proposals for ai projects for years. as these projects come to fruition, more communicators will join the effort and find that the complicated and sometimes obscure methods used to develop ai applications can pose a challenge to effective communication about ai. although many standard research design concerns (eg, hypothesis, sample size, data quality and representativeness, design rigor, multidisciplinary representativeness of the team, generalizability) also apply to ai model development, communicators must also interrogate designs for ai-specific matters (eg, portability of the model, validation and testing plan, human–ai team required for implementation, maintenance plan to address drift). for ai applications being developed for clinical use, the fda’s good machine learning practice for medical device development: guiding principles document6 provides excellent, clear guidance. many of the points on their list of guiding principles should be considered in the research design development and proposal writing stages, in addition to the funder’s explicit requirements. when writing about ai-based health care apps, the importance of understanding how researchers develop these applications quickly becomes apparent, but, when writing with ai apps, one may ask why any of the technical aspects of ai matter to the end user. generative ai applications are, after all, a tool—but every good craftsperson knows their tools. communicators using generative ai in their practice likewise should understand the tools. in the medical writing and editing practices, this largely means understanding gpts. gpts are a type of llm. llms sit at the intersection of dl and natural language processing, an ai domain specific to teaching machines to understand and generate human language. llms use dl techniques applied to enormous data sets. their objective is to understand and generate text based on what they have learned from the data they have ingested. although their output sounds human, it is the output of a statistical model, like any other gpt. the text is the algorithm’s best statistical prediction of what the next word (and then the next and the next) should be. unlike earlier ai, like predictive text that suggests a word or brief figure 1. ai is typically divided into 2 categories: weak ai and strong ai. although strong ai is the goal of the ai field, weak ai represents the current state of the science. ai, artificial intelligence. http://www.amwajournal.org amwajournal.org e3communicating about and with artificial intelligence applications phrase, generative ai takes a holistic approach, creating a more complex model that understands the larger context of sentences and paragraphs and can generate paragraphs of cohesive and coherent human-sounding text. some medical communication products especially suitable for generative ai production include patient education materials, medical guidelines, package inserts, patient-facing chatbots to answer medical questions, patient discharge instructions, and letters (to insurers, employers, etc),7 and other plain language materials. using consumer gpts to generate technical content consumer versions of gpts hit the market big with dall-e and then chatgpt in 2022. in the intervening time, the gpt offerings have only multiplied and expanded across tasks, including writing, image generation, programming, and data analysis. developers train consumer gpts on the internet, meaning the gpts ingest online content, good and bad. although that is a large amount of data by anyone’s standards, a consumer gpt’s training is limited to the data to which it had access, including copyrighted material (in violation of copyright laws),8 but without access to paywalled peer-reviewed content and with training cutoffs that may mean the most recent content is months or years old.† however, high-quality medical communication requires accurate, detailed, and current sources, so the quality of most content generated by consumer gpt applications may not meet those standards, especially for more complicated or technical topics. the human quality of gpts’ language can cause users to trust the applications’ content more than they should. gpts provide inaccurate and biased information and plagiarize their sources—all issues ethical medical communicators cannot ignore. and, although the human-sounding quality of the content increases the value of gpt-generated content in many contexts, consumer gpts have a limited ability to generate meaningful technical language. using proprietary or enterprise models to generate technical content to protect intellectual property, including research data and information about a novel technology or design, some companies have implemented proprietary or enterprise purpose-built models, trained on the research corpus specific to their industry and organization. often these are sparse expert models (<100 billion parameters vs chatgpt version 3.5’s 175 billion parameters), which can be more accurate than larger general models because the data ingested are more specific to the users’ needs. unlike consumer gpt applications, the models are trained with industry-appropriate information, including paywalled articles, then further trained on the organization’s data. data ingested by private generative models are only available to members of the organization. but, like consumer gpt applications, the tendency of the technology to prevaricate, hallucinate, and plagiarize persists in these models, too. conclusion regardless of the type of ai application being used, whether it is an application for analyzing imaging or one for generating content for a patient education website, current ai applications are imperfect tools for our use. these tools augment human productivity, intelligence, and creativity if used strategically and well, which will result in a shrinking of the workforce.9 as erik brynjolfsson, director of the stanford digital economy lab, summarized the situation for knowledge workers, “i think if done right, it's not going to be ai replacing lawyers. it's going to be lawyers working with ai replacing lawyers who don't work with ai.”10 similar to earlier industrial revolutions, the fourth industrial revolution brings technologies that will displace workers who perform work that new technologies can do faster and cheaper. but teams will always have a need for communicators with domain expertise or other exceptional skills who ethically and effectively use these tools in their practice. acknowledgment i thank john w. byram for his review of the manuscript. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: kellybyram@dukecityconsulting.com references 1. turing am. i.—computing machinery and intelligence. mind. 1950;lix(236):433-460. doi:10.1093/mind/lix.236.433 2. ochotny n. the use of artificial intelligence and machine learning in clinical research and health care. am med writ assoc j. 2023;38(1). doi:10.55752/amwa.2023.241 3. faverio m, tyson a. what the data says about americans' views of artificial intelligence. pew research center website. updated november 21, 2023. accessed january 8, 2023. https://www. pewresearch.org/short-reads/2023/11/21/what-the-data-saysabout-americans-views-of-artificial-intelligence/ 4. biever c. chatgpt broke the turing test the race is on for new ways to assess ai. nature. 2023;619(7971):686-689. doi:10.1038/ d41586-023-02361-7 †after this presentation last year, more consumer gpts have introduced real-time web search functionality. in practical terms, a gpt with realtime search capabilities may have been trained through september 2021, for example, but it can search the internet for information in real time. for many casual users employing a consumer gpt with realtime search functionality, the training date of the gpt has become a distinction without a difference. http://www.amwajournal.org https://www.pewresearch.org/short-reads/2023/11/21/what-the-data-says-about-americans-views-of-artificial-intelligence/ https://www.pewresearch.org/short-reads/2023/11/21/what-the-data-says-about-americans-views-of-artificial-intelligence/ https://www.pewresearch.org/short-reads/2023/11/21/what-the-data-says-about-americans-views-of-artificial-intelligence/ amwajournal.org e4communicating about and with artificial intelligence applications 5. alowais sa, alghamdi ss, alsuhebany n, et al. revolutionizing healthcare: the role of artificial intelligence in clinical practice. bmc med educ. 2023;23(1):689. doi:10.1186/s12909-023-04698-z 6. good machine learning practice for medical device development: guiding principles. us food and drug administration. october 27, 2021. accessed may 14, 2024. https://www.fda.gov/medicaldevices/software-medical-device-samd/good-machine-learningpractice-medical-device-development-guiding-principles 7. doyal as, sender d, nanda m, serrano ra. chatgpt and artificial intelligence in medical writing: concerns and ethical considerations. cureus. 2023;15(8):e43292. doi:10.7759/ cureus.43292 8. grynbaum m, mac r. the times sues openai and microsoft over a.i. use of copyrighted work. new york times. december 27, 2023. accessed december 27, 2023. https://www.nytimes. com/2023/12/27/business/media/new-york-times-open-aimicrosoft-lawsuit.html 9. doumi l, goel s, kovács-ondrejkovic o, sadun r. reskilling in the age of ai. harvard business review. september-october 2023. accessed may 14, 2024. https://hbr.org/2023/09/reskilling-in-theage-of-ai 10. oliver, j. artificial intelligence: last week tonight with john oliver [video]. https://youtu.be/sqa8zo2xwc4. published february 27, 2023. accessed june 24, 2024. http://www.amwajournal.org https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles https://www.nytimes.com/2023/12/27/business/media/new-york-times-open-ai-microsoft-lawsuit.html https://www.nytimes.com/2023/12/27/business/media/new-york-times-open-ai-microsoft-lawsuit.html https://www.nytimes.com/2023/12/27/business/media/new-york-times-open-ai-microsoft-lawsuit.html https://hbr.org/2023/09/reskilling-in-the-age-of-ai https://hbr.org/2023/09/reskilling-in-the-age-of-ai https://youtu.be/sqa8zo2xwc4 v39 n4 / 2024 ©2024 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 40 abstract in recent decades, huge strides have been made in the field of genetics. genomic analysis technology has enabled scientists to explore how genetics affect every aspect of human life and development. genetic testing is poised to be at the forefront of contemporary medicine. parents often grapple with the correlation of their child’s genetic mutations and serious diseases. at a time when misinformation spreads through the popular press like wildfire, we are recounting the xyy story as a cautionary tale to highlight the importance of scientists speaking up and standing against the misuse of genetic information. the visualization of human chromosomes in the 1950s opened an important era of discovery in biomedical sciences. scientists marthe gautier and jérôme lejeune were the first to identify the extra chromosome that caused trisomy 21, better known as down syndrome.1 karyotype analysis, or the analysis of human chromosomes, then led to the discovery of hundreds of other chromosomal variations that have proven to be essential for the diagnosis of genetic diseases. although advances in genetics have led to effective treatments, they have also been used to draw lasting damaging and false connections between genetic profiles and human behavior. karyotype analysis eventually led the research group of geneticist patricia jacobs2 to ask whether an extra y chromosome correlated with more aggressive behavior and criminality. the research for the answer to this question had many unforeseen consequences. the stigma that developed around xyy syndrome caused a cascade of unfortunate issues. in this article, we recount cases of inequality, premature pregnancy termination, and misinformation in the health care system regarding the xyy chromosome diagnosis. we showcase this example to make readers aware of how current cases of chromosomal variation could create bias in medical diagnoses. review xyy syndrome (also known as 47, xyy, and jacobs syndrome) is a genetic condition in which individuals born with male sex, who typically have one x and one y chromosome, have an extra y chromosome. the syndrome, which occurs in 1 out of every 1,000 individuals born with male sex, is shown by recent data to have effects on fertility and an increased possibility for an atypical neurocognitive phenotype. although research is limited, there is evidence of slightly altered or slowed development of reproductive organs in people with xyy syndrome. studies have also shown that supernumerary sex chromosome syndromes, including xyy, place children at an increased risk to show symptoms of autism spectrum disorder.3 the jacobs team examined the karyotypes of inmates at the former state hospital for the criminally insane in carstairs, scotland. in 1965, jacobs et al2 published an article in nature observing that 3.5% of inmates of the edinburgh institution carried an extra y chromosome. although jacobs et al2 concluded that the individuals with the xyy karyotype were likely not very different from the non-xyy prisoners, the article was poorly titled “aggressive behavior, mental sub-normality and the xyy males.” the title apparently reflected what they were asking, not what they found, but it nevertheless suggested an association between the xyy genotype and criminality. the title opened the flood gates for popular news outlets to disseminate the information implied by the title as established scientific evidence. science digest and time magazine reported on jacobs et al’s2 research using headlines like “chromosomes and crime.”4 although this was not the case, such stories in the press led to public concern about people carrying an extra y chromosome. bias against people with xyy was also perpetuated through various news stories. in 1966, 8 nurses in chicago were murdered by richard speck. because of miscommunication between a journalist and scientist, news spread attributing speck’s homicidal behavior to his having the xyy mutation, even when blood tests proved otherwise.5 helena i. ebeling1 and jonathan r. beckwith, phd2 / 1undergraduate, department of biology, boston college, chestnut hill, ma; 2emeritus professor, department of microbiology, harvard medical school, boston, ma the xyy story as a cautionary tale: how scientific misinformation and common biases can negatively impact lives and opinions everyday ethics http://www.amwajournal.org amwajournal.org 41the xyy story as a cautionary tale in the years following the original publication, jacobs’ claims of the link between xyy and criminality were further disproved. it was revealed that many individuals in the study done by jacobs et al2 who had the xyy genotype had committed petty crimes against property, not people.6 additionally, subsequent studies analyzing the proportion of individuals with xyy in criminal institutions never came close to the 3.5% that jacobs et al found in their original study. despite these findings, xyy testing and the stigmatization of individuals with an extra y chromosome continued. during president nixon’s time in office, his personal psychiatrist, adviser, and confidante, dr hutschneker, suggested that all 7to 8-year-olds in underserved or poorer areas be karyotyped for homicidal or violent tendencies. if these children were an xyy match, hutschneker suggested that they be placed in interventional institutions.5 this practice perpetuated an extremely dangerous stereotype of criminalizing people from marginalized groups, rather than attributing their behavior to their childhood, surroundings, or the racist biases that incriminate them. in 1973, a group of young researchers and doctors at harvard medical school in boston, including dr jonathan beckwith, learned that a researcher at boston lying-in hospital was seeking pregnant women who might allow the study of their newborns to determine which, if any, malesexed newborns had xyy syndrome. the consent form did not disclose that the chromosome analysis was being supported by the crime and delinquency division of the national institute of mental health.7 if the newborns had the xyy karyotype, dr stanley walzer, who was leading the study, would contact the parents to inform them and offer his help and observation as the children grew up. the skeptical group of harvard scientists, including author beckwith, had seen the dangers in the xyy screening as a self-fulfilling prophecy and proposed that harvard medical school’s standing committee on medical research evaluate the xyy screening protocol and potentially suspend it, if warranted.7 after the harvard committee initially stated that the study should continue, the critics of the project approached the children's defense fund in boston, which in turn contacted the massachusetts attorney general and the study was finally halted. the publicity from this halted study resulted in the cessation of similar studies elsewhere as addressed by hamerton in his presidential address to the american society for human genetics.8 the new york times covered the change in sentiment about the xyy karyotype in an article titled “a chromosome link to crime is doubted”9 in 1976. the article mentioned that the original conclusion that individuals with xyy were more likely to be criminals was false. rather, it was more likely that the slight increase in criminality was typically caused by a lower intelligence quotient and autism spectrum disorder associated with the chromosomal mutation.9 the paper also interviewed dr witkin, an american psychologist who pioneered developments in perception as it related to learning. dr witkin suggested that society would not gain anything from identifying individuals with xyy and placing them into intervention. rather, he recommended that the educational and cognitive deficiencies that were associated with the xyy karyotype should be dealt with when problems arise.10 in 1982, 17 years after the publication of her original paper,2 dr jacobs retracted her initial statements saying, “in retrospect, i should not have used the words ‘aggressive behavior’ in the title of my paper and should not have described the institution as a place for ‘the treatment of individuals with dangerous, violent or criminal propensities.’”11 still, the xyy narrative persisted for many years in the media, with various episodes of law and order and the film alien 3 featuring an antagonist with the xyy karyotype. a hastings center conference report in 1980 queried various geneticists and scientists on their opinion and experience with the xyy controversy. saleem shah, an indian-american psychologist who worked closely with mental health and the law, noted that when having the xyy karyotype made somebody a criminal, he “started to receive calls from attorneys asking what [he] knew about the extra y chromosome and its relevance to the legal issue of criminal responsibility.”12 despite all the trouble stemming from the initial jacobs et al2 xyy study, additional researchers over the past 30 years have sought to link negative behavior to genetics. in 1993, a dutch group reported that individuals carrying a mutation eliminating the function of a gene for monoamine oxidase a (maoa) were more likely to exhibit abnormal and sometimes violent behavior.13 many of the individuals with this mutation came from the pacific islands, and the mutation was named the warrior gene.14 as in the case of individuals with xyy, the warrior gene was stigmatized, and those with the mutation were classified as aggressive or having violent behavioral tendencies. in a 2016 publication, a group of researchers in india claimed that the presence of barr bodies, chromatin structures formed from the condensation of x-chromosomes, was linked to criminality in men. the article entitled “do the presence of barr bodies in male jail inmates indicate criminality: a pilot study”15 studied an exceedingly small sample of 100 inmates and concluded that individuals with barr bodies were likely to become criminals. articles with suggestive titles describing studies with faulty experimental procedures pose a great threat to science and society. as in the xyy case, these studies are http://www.amwajournal.org amwajournal.org 42the xyy story as a cautionary tale overrepresented in the media. deceptive media coverage leads society to promote false beliefs about various groups and instills fear of people with certain genetic makeups. minority groups and low-income families or targeted racial and ethnic groups are the first to be marginalized and presumed to have conditions involving behaviors stereotypically associated with these groups. current implications in more recent studies, scientists continue to use genetic ancestry to shape societal values. increasingly, geneticists are working with social and behavioral scientists to connect certain phenotypes in a genetic ancestry to specific behavioral and cognitive outcomes. recent social and behavioral genetic (sbg) studies have determined that the phenotypes that some scientists say are predictors of one’s social, intellectual, or economic outcome in life are no more predictive than family income and geographical location. jonathan beckwith once importantly noted that many flawed genetic studies attempt to “explain away problems by genes and distract attention from social conditions that cause problems.”16 in an article published in “the ethical implications of social and behavioral genomics,”17 the authors caution that if sbg studies analyzing phenotypes are to be conducted, they must be carefully reviewed, evaluated, and sometimes restricted from publication.17 genetic testing has its benefits as well. genetic testing helps physicians define chromosomal mutations and genetic disorders that may inhibit or alter childhood development, so parents may be prepared and take preemptive steps for their child. it is when this genetic testing is used for purposes other than ensuring the health of an individual or the population, that it becomes a detriment to society. a world in which a person’s every trait can be predicted by their genetic ancestry and makeup is a very dystopian one. although futuristic science and technology can act as forces of progress, they can just as easily spread information that can be used to alter societal opinions. it is our duty as scientists to speak up against bad science just as jonathan beckwith and his colleagues did during the initial xyy study. in the wake of the covid-19 pandemic, the problem of misinformation is metastasizing—with more and more retractions from high impact factor journals, the demise of numerous online journals populated with manuscripts generated by paper mills, and the popularization of artificial intelligence (ai)-generated content. scientists, editors, publishers, and even readers bear an increased responsibility for preventing inaccurate or misleading titles and content from being published and popularized. preventive measures could include a more thorough vetting of submissions for publication and soliciting of diverse opinions and expanded use of ai detection software that would prevent the use of computer-generated or modified images and content. misinformation can spread like wildfire. therefore, it is essential that scientists consider the broader social context and consequences of misleading, or frankly false, information. acknowledgments dr beckwith has had a long and extremely successful career in the field of genetics and microbiology. in his early career, he led the research group that isolated the first gene from a bacterial chromosome, and his research continued to flourish from there. mostly notably, outside of his career in scientific research, he is a controversial activist of social justice and civil liberties in the science community. he was an important organizer in the activist organization science for the people, which fought against inequality and unethical practice in the field of science. he continued his career as the american cancer society research professor of microbiology and molecular genetics at harvard medical school. i (helena ebeling) am an undergraduate student at boston college, with an aspiration for medical school. my interests mainly lie within genetics and scientific communication as technology advances. working alongside dr beckwith and his deep conviction in the importance of communication in the impact of science and society has sparked the same passion in myself. dr beckwith has more recently been struggling with an alzheimer disease diagnosis. in an effort to keep the words of one of the most brilliant minds alive, he and i drafted this manuscript together as he recounted his efforts in the 1970s to prevent unethical research and shared his opinions on more recent ethical dilemmas. together, we reviewed articles, studies, and news publications surrounding the controversial case of the xyy karyotype, as well as paralleling current research. dr beckwith has been my inspiration as he continues to amaze with his knowledge and dedication to this cause. with this article, i hope that his insight can be passed on and be an inspiration for the future of medicine and research. i thank emrah altindis, phd, for introducing me to jon beckwith, as well as susan michaelis, phd, and fariba houman, phd, for their suggestions and support in writing this article. author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. author contact: hebeling2@gmail.com http://www.amwajournal.org amwajournal.org 43the xyy story as a cautionary tale references 1. lejeune j, gauthier m, turpin r. human chromosomes in tissue cultures. article in french. c r hebd seances acad sci. 1959;248(4):602-603. 2. jacobs pa, brunton m, melville mm, brittain rp, mcclemont wf. aggressive behavior, mental sub-normality and the xyy male. nature. 1965;208(5017):1351-1352. 3. gravholt ch, ferlin a, gromoll j, et al. new developments and future trajectories in supernumerary sex chromosome abnormalities: a summary of the 2022 3rd international workshop on klinefelter syndrome, trisomy x, and xyy. endocr connect. 2023;12(3):e220500. 4. montagu a. chromosomes and crime. psychol today. 1968;2(5): 43-49. 5. goode e. arnold hutschnecker, 102, therapist to nixon. new york times. published january 3, 2001. accessed may 2, 2023. https:// www.nytimes.com/2001/01/03/us/arnold-hutschnecker-102therapist-to-nixon.html 6. ratcliffe s. long term outcome in children of sex chromosome abnormalities. arch dis child. 1999;80(2):192-195. 7. beckwith j, elseviers d, gorini l, mandansky c, csonka l, king j. harvard xyy study. science. 1975;187(4174):298-299. doi:10.1126/ science.11643259 8. hamerton jl. human population cytogenetics: dilemmas and problems. am j hum genet. 1976;28(2):107-122. 9. brody je. a chromosome link to crime is doubted. new york times. published september 12, 1976. accessed may 12, 2023. https://www.nytimes.com/1976/09/12/archives/a-chromosomelink-to-crime-is-doubted-study-in-denmark-finds-no.html 10. witkin ha, mednick sa, schulsinger f, et al. criminality in xyy and xxy men. science. 1976;193(4253):547-555. 11. jacobs pa. the william allan memorial award address: human population cytogenetics: the first twenty-five years. am j hum genet. 1982;34(5):689-698. 12. bauer d, bayer r, beckwith j, et al. special supplement: the xyy controversy: researching violence and genetics. hastings cent rep. 1980;10(4):1-31. doi:10.2307/3560454 13. brunner hg. maoa deficiency and abnormal behaviour: perspectives on an association. ciba found symp. 1996;194: 155-164. 14. mcdermott r, tingley d, cowden j, frazzetto g, johnson ddp. monoamine oxidase a gene (maoa) predicts behavioral aggression following provocation. proc natl acad sci usa. 2009;106(7):2118-2123. 15. kulkarni mk, somannavar pd, kotrashetti v, nayak r, hosmani j, babji d. do the presence of barr bodies in male jail inmates indicates criminality: a pilot study. j oral maxillofac pathol. 2016;20(1):11-15. 16. hewson ms. harvard, mit scientists blast boston study of male genes. the harvard crimson. published november 16, 1974. accessed october 10, 2023. https://www.thecrimson.com/ article/1974/11/16/harvard-mit-scientists-blast-boston-study 17. meyer mn, appelbaum ps, benjamin dj, et al. wrestling with social and behavioral genomics: risks, potential benefits, and ethical responsibility. hastings cent rep. 2023;53(suppl 1):s2-s49. explore now evidence-based medicine available in amwa online learning individual patient clinical expertise medical evidence www.amwa.org/online_learning http://www.amwajournal.org https://www.nytimes.com/2001/01/03/us/arnold-hutschnecker-102-therapist-to-nixon.html https://www.nytimes.com/2001/01/03/us/arnold-hutschnecker-102-therapist-to-nixon.html https://www.nytimes.com/2001/01/03/us/arnold-hutschnecker-102-therapist-to-nixon.html https://www.nytimes.com/1976/09/12/archives/a-chromosome-link-to-crime-is-doubted-study-in-denmark-finds-no.html https://www.nytimes.com/1976/09/12/archives/a-chromosome-link-to-crime-is-doubted-study-in-denmark-finds-no.html https://www.thecrimson.com/ american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. v38 n2 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 61 abstract the fourth annual medical writing executives forum took place during the 2022 american medical writers association (amwa) medical writing & communication conference with the aim of bringing together heads of medical writing departments to discuss relevant topics in medical writing. this year’s theme focused on the development of a framework for a medical writing apprentice program. the participants shared their experiences to begin laying the foundation for a successful medical writing apprentice program framework that can be customized and deployed as needed to help develop and grow the next generation of medical writers. introduction in 2018, the american medical writers association (amwa) began an executives forum initiative with the aim to convene medical writing department heads to interact and discuss topics of interest in the medical writing field. against that backdrop, the fourth annual executives forum took place on november 2, 2022, in denver, colorado, led by julia cooper, chair of the amwa executives advisory council. the forum attendee companies, provided in table 1, included representatives of small, midsize, and large pharma; contract research organizations; and other service providers. the theme was how to develop an apprentice program as a valuable tool to support the future of medical writing by offering an educational opportunity to the candidates as well as supporting the growth of the involved companies. the forum began with a presentation of the results of an amwa survey conducted in 2022 to obtain a snapshot of existing apprentice programs within the medical writing community. the survey presentation was a great starting point and provided context to forum participants. however, the survey is not the focus of this article and will be discussed in greater detail in a separate publication. for the main part of the forum, participants were divided into 6 breakout groups, each addressing a specific subject related to apprentice programs, including considerations for a business case, guidance on program structure and duration, core topics, learning methods, best practices for recruitment, and defining success of the program. this manuscript details the discussion of forum members with the goal of supporting amwa members in justifying, establishing, recruiting, and assessing the success of an apprenticeship program. considerations for a business case apprenticeships and similar programs are an effective way to develop a pipeline of new medical writing talent. such programs require allocation of significant time and resources to achieve the desired outcome, and in many companies, a business case is needed to obtain approval to amwa’s fourth medical writing executives forum: creating an apprentice program to develop the next generation of medical writers marta mas,1 janice worley,2 shiri diskin,3 lynne munno,4 robin whitsell,5 and julia cooper6 / 1tfs healthscience, barcelona, spain; 2propharma, raleigh, nc; 3bioforum group, tel aviv, israel; 4takeda, cambridge, ma; 5whitsell innovations, inc, chapel hill, nc; 6parexel international (irl) limited, dublin, ireland amwa news table 1. 2023 medical writing executives forum attendee company list • abbvie • alexion, astrazeneca rare disease • amgen inc. • amwa • astellas pharma • bannick llc, a primary device group • bioforum cdmc • boehringer ingelheim • bristol myers squibb • certara synchrogenix • csl behring • genmab • gilead sciences • icon plc • incyte • janssen, johnson & johnson • jazz pharmaceuticals • merck & co., inc. • moderna, inc. • organon • otsuka pharmaceutical development & commercialization • parexel • pfizer • propharma • ptc therapeutics • reata pharmaceuticals • regeneron pharmaceuticals, inc. • rrd international, llc • seqirus, a csl company • spark therapeutics • syneos health • synterex, inc. • syros pharmaceuticals • takeda • tfs healthscience • trilogy writing & consulting • whitsell innovations, inc. • zentalis http://www.amwajournal.org amwajournal.org 62amwa’s fourth medical writing executives forum proceed. the breakout group discussed how best to present the benefits and return on investment for typical apprentice programs. it was recommended to divide the business case into financial benefits, which can usually be quantified at some level, and benefits that can be more difficult to measure, such as cultural and efficiency gains. examples of financial benefits include: • recruiter cost savings. it is often easy to hire entrylevel employees for an apprentice program, whereas hiring at a senior level could involve expensive recruitment agencies. • lower cost resource. although not fully trained, apprentices can often get involved in simple project work a few months into the apprentice program at a lower cost. this frees up senior-level resources to focus on more complex documents. even if additional hours are factored in, to account for apprentices needing a little longer to complete the same task, there can still be an overall cost saving. • senior-level writers hired may still need substantial training in the company processes and (in some cases) because of misalignment between senior role expectations across companies, which could potentially cost more than trainees. • because of pressure on availability of senior writers in the market, an apprentice program can allow the group to grow faster than if only senior writers are hired. • apprentice programs that include an element of cross-training facilitate scalability in line with business needs. • attrition is generally lower among apprentices as they build strong bonds and loyalty to the company. this can be enhanced through completion bonuses or stock options to promote retention. • allowing senior writers to train apprentices while still working on billable activities may reduce senior writer attrition because experienced writers often find delivering training very rewarding. trainers could be provided a time budget as a guide on how long to spend, and these hours should be included in the overall apprentice program budget. reduced senior writer attrition stabilizes compensation models because frequent movement between companies drives up salaries. qualitative benefits include the following: • apprentices are trained in the company processes from the start (no undoing of bad habits required). • through a targeted hiring strategy, apprentice programs create a larger, more diverse pool of welltrained medical writers. • sharing the work between the apprentices and their senior colleagues (eg, through job shadowing) forms strong bonds and relationships in the department. • apprentices provide useful support to senior writers, allowing the senior writers to delegate some of the work and improve their own work-life balance. • apprentice programs provide a forum for informal knowledge-sharing between less experienced and senior writers. • attrition among apprentices is typically lower, which improves morale across the team. • by developing strong, well-trained medical writers, apprentice programs contribute to improvement in the overall quality of clinical research. • apprentice programs can be an integral part of a robust succession planning and sustainability strategy. when faced with the need to justify the development of a medical writing apprentice program, understanding and identifying specific internal business drivers and quantifying longand short-term advantages will help with building a well-rounded business case. guidance on program structure and duration once the business case has been established, the first step for any company in creating an apprentice program should be to define their goal. the breakout group acknowledged that this may vary from company to company; thus, it is important to define the structure and duration of an apprentice program, and the following questions should be considered: structure • is the goal to have someone write something as quickly as possible? or is it to develop and retain medical writers with soft skills and broader context? • should the program be time-based, competency-based, or a hybrid? • how many apprentices should be brought in at one time? • if the company is small, how will the concept of an apprentice program be applied? • should the program include fellowships partnering with an academic institution? • would apprentices be hired who do not have the typical educational background or skill set that is generally sought after when hiring medical writers? if yes, how will the program be adapted? http://www.amwajournal.org amwajournal.org 63amwa’s fourth medical writing executives forum duration • what is the overall recommended duration for an apprentice program cycle? in answer to some of the above questions, the breakout group recommended the following: 1. using a hybrid approach in which the company defines competencies based on their current and future business needs while identifying the needs and/or gaps of the individual and defining the timeframe in which those competencies should be demonstrated. 2. bringing in cohorts of at least 2 depending on the size of the company, business needs, and the availability of senior-level medical writers to train. 3. using an apprentice program even if the company is small, because it can be adapted and customized for each company, regardless of size. 4. using an academic institution if the company has a relationship with one. 5. hiring apprentices who do not fit the mold of a regular medical writer, which can bring the benefit of diversity of thought and experience to the company. however, if this is done, a needs assessment/gap analysis should be performed and the individual’s apprentice program experience tailored accordingly. 6. establishing an apprentice program with a duration of anywhere from 6 months to 2 years depending on program structure and individual and/ or company needs. the breakout group proposed a suggested duration for an example program in figure 1. in year 1, the medical writer works on lower complexity documents, and as they gain document knowledge and build an understanding of medical writing concepts, they move onto higher complexity documents in year 2+. the ultimate goal of the program would be for the medical writer to independently manage a project from start to finish. core topics the next step in building a medical writing apprentice program is to identify the specific content or curriculum that will form the basis of the program. because medical writing is more than simply putting words on a page, the participants in the core topics breakout group agreed that a wellrounded medical writing apprentice program will include not only technical training on medical writing–related skills but also provide a solid foundation of broader, essential soft skills training (eg, project/stakeholder management, time management, etc.). the goal of this discussion was to identify the core topics for inclusion in the program as well as what specific content should be included within each area. the discussion centered on some of the most relevant skills that contribute to being a proficient medical writer, irrespective of what type of documents are being written, and to identify and outline core topics and suggest minimum content within each of them. the 4 core topic areas or domains agreed upon by the breakout group for inclusion in an apprentice program are presented in figure 2. the content of each core topic area was explored, and the participants in the breakout group agreed that within each topic or domain, the list of individual subtopics could vary significantly depending on how the program will be deployed. medical writing–related skills and knowledge the participants in the breakout group acknowledged that these skills form the initial basis of a solid medical writing apprentice program. it was agreed that there is a minimum level of core knowledge that every individual needs as they embark on their journey to becoming a medical figure 1. suggested apprentice program duration. figure 2. apprentice program model core topics. mw, medical writing. http://www.amwajournal.org amwajournal.org 64amwa’s fourth medical writing executives forum writer. an understanding of the drug development process, the relevant documents within the development lifecycle, and how they all relate to each other is a fundamental requirement, especially for a regulatory medical writer. in addition, the participants in the breakout group felt it was essential to instill a solid understanding of basic statistics, lean authoring, and good documentation principles. other skills included knowledge of technology-driven tools, document preparation, and review processes as well as the use of the quality check (qc). this is not a comprehensive list of all the medical writing–related skills and knowledge, but it represents an essential starting point for establishing a solid foundation in medical writing. the group acknowledged that customizations to this core topic could include building out document and/or therapy area-specific trainings. time/project management within this core topic, the participants in the breakout group agreed that any curriculum for an apprentice medical writer program should include a basic education on project planning, execution, and management. this would include, at a minimum, training on timeline development and management as well as training on essential skills of negotiation, decision-making, time management, prioritization, and risk mitigation and management. the focus of the discussion centered on these topics, and the participants acknowledged that other aspects of this topic could be included but that these represented a vital primary skill set for a medical writer to master. communication medical writing at its core is about effective and purposeful communication, on and off the page. within this subset of skills, there are many different types of training that could be implemented and deployed. however, the participants in the breakout group agreed that a robust medical writing apprentice program should include training on appropriate and effective professional communication. an important and often overlooked aspect of communication in medical writing is how to establish and align expectations, which is crucial when working with a group of cross-functional stakeholders and contributors. another fundamental aspect of the communication skill set for a medical writer to master is effectively driving and leading team meetings. incorporating essential training around managing and driving meetings, including how to influence without authority, was considered by the breakout group participants to be an essential facet of any medical writing training program. teamwork most medical writers operate as part of a cross-functional team and in some cases function as a process driver, driving the overall development of a medical writing deliverable. this requires a level of leadership and the ability to navigate the individual team dynamics to solve problems, mediate differences of opinion, and foster and encourage group harmony. although these skills take time and confidence to build, the participants in the breakout group agreed that a medical writing apprentice program should include specific training to begin developing them as early as possible. several topics were identified for inclusion such as navigating difficult personalities and interpersonal relationships, conflict resolution and problem solving, and navigating team lifecycle and contingency planning. the participants in the breakout group acknowledged that this was one core topic that could have a large variety of topics covering a broad range of soft skills. learning methods another important factor for consideration in the apprentice program model is how the curriculum will be delivered. this breakout group discussed some learning methods that have been tried in different medical writing departments and have been proven to work well as well as who should deliver the training. the breakout group agreed that as a starting point, each person’s baseline knowledge/skill set and background (talent assessment) should be evaluated at entry to serve as a basis for and guide the individualization of the apprentice program. this evaluation should not rely solely on self-presentation of a candidate because they could overestimate their experience or the extent to which their previous writing tasks (eg, journal articles or grant applications during graduate school) qualify them to perform regulatory writing tasks or highly complex medical communication projects. it was also agreed by the breakout group that it was important for training to start as early as possible. when considering specific learning methods, some of the established methods recommended by the breakout group included the following: • completion of the amwa essential skills program • completion of mock writing tasks (could also be used as talent assessment tools) • implementation of simple qc findings • review of completed documents and team/qc comments on drafts to understand expectations from specific document types as well as learn the style guide and get acquainted with working processes • completion of live project work – partnering with a senior writer as a contributor (eg, writing document sections, performing qcs) http://www.amwajournal.org amwajournal.org 65amwa’s fourth medical writing executives forum • gradual advancement to writing full low-level, low-complexity documents • attending project meetings, such as kickoff meetings, data interpretation meetings, comment resolution/ consensus meetings and lessons-learned meetings (even if outside the assigned teams). it was recommended to have the trainee engaged in the meeting by taking minutes rather than simply being a passive participant. • participation in meeting debriefings (lessons learned: how to read the room, understanding the approach and the strategy) the breakout group also emphasized the need for softskill training. some methods that can be applied to train medical writers on soft skills include the following: • completion of relevant amwa courses and workshops • presentation to colleagues (eg, sharing learnings from attending amwa, presenting a timeline to a team) in support of having the trainee learn and experience how to orally communicate the most important points clearly and effectively • shadowing a senior medical writer and observing how projects are managed and problems are solved ongoing assessments should be based on bidirectional periodic feedback sessions wherein managers/senior writers provide feedback on the apprentice’s progress (using competency-based evaluations) and apprentices provide feedback on the program’s effectiveness. the completion of the apprenticeship or promotion to the next level in the medical writing role hierarchy would be defined by the ability to autonomously drive the development of at least one document type (predefined by apprentice program guidelines or job descriptions) with independent de novo content development. it can be said that it “takes a village” to train a medical writer because it requires input from several different types of trainers. internal or external subject matter experts (at all levels) often develop and deliver formal training sessions. from there, senior medical writers are often leveraged as “buddies” to provide ongoing support, guidance, and mentoring. being a mentor and “trainer” may require specific train-the-trainer training, so the need for this type of training should be considered in an apprentice program model. in addition, this extra responsibility should be included in the senior writer’s job description. best practices for recruitment once the program has been designed and is ready to deploy, it’s time to identify potential candidates for the program. the recruitment process for potential medical writing candidates is a key consideration for the success of an apprentice program. as previously mentioned, an apprentice program can be an effective way to develop a pipeline of new medical writing talent, which is a win-win for both the company and the candidate having a long-term career path. the participants in this breakout group discussed several topics that should be considered in the selection process of the candidates. process to start. the first step for recruiting candidates for an apprentice program is a successful advertisement “campaign.” to that end, fostering relationships with academic institutions was seen as a particularly good option by the participants because this provides visibility into a large pool of potentially strong apprentice candidates. to do this, the interested companies can organize open sessions or webinars with graduates to explain the medical writing profession and the structure of the program they are offering. in addition to posting the job on the standard job search platforms, another potential strategy could be to leverage social media such as linkedin and include a brief questionnaire that allows the company to have an initial interaction with possible candidates. defining the right profile. medical writing is not an academic discipline, and medical writing professionals come from many diverse backgrounds. the participants agreed that a background in the life sciences (either by training or work experience) is a good starting point for profiling prospective candidates (based on initial review of the cv and cover letter). in addition, other important skills would be a passion for communication and writing (a good cover letter and possible previous publications can be a good way to evaluate this), curious scientific spirit (that will support working in different therapeutic areas and documents), and social skills (to develop project management responsibilities). selection process. first, the breakout group considered that knowing how to effectively evaluate resumes, paying attention to the grammar style, formatting, and technical skills, was an important first step to start the selection process. if a cover letter accompanies the resume, a well-written one can demonstrate not only an aptitude for writing but an interest in obtaining the position. once potential candidates are identified, one way to further screen a candidate is to administer a timed writing assessment before the interview. the participants believed this could be an effective way to evaluate a candidate’s writing skills. however, this may not be allowed in some companies because of internal hr policies, so it may not always be feasible. if an assessment is used, it is important to ensure the same assessment is used http://www.amwajournal.org amwajournal.org 66amwa’s fourth medical writing executives forum for all candidates and that a uniform, objective method to score the assessment is implemented. finally, the participants agreed that the final pivotal piece of the selection process is a comprehensive interview to understand the full profile of each candidate and make an informed decision. interview questions. the participants discussed different interview questions that would be the most effective and meaningful to identify appropriate apprentice candidates. they agreed that a combination of role-specific questions, general questions related to personality and/or behavior, and questions around previous experience were good starting points for an interview. some of the questions included: • why are you applying? why this company? (shows preparation and motivation for the role) • what do you understand medical writing to be? • panel interview with behavioral questions (eg, tell us about challenges you have overcome and how) title within the organization. the breakout group considered the topic of possible job titles for an apprentice going through the program. suggestions for a title included associate, fellow, or trainee. although this can be defined in the framework of the program, the participants felt it could also be driven by or depend on the hr policies of the individual company. possibility of developing multiple training tracks. the breakout group also considered the possibility of having multiple training “tracks” within the apprentice program, for example, having an accelerated program (vs a standard duration or longer program) for people with advanced degrees or candidates with minimal writing experience compared with less experienced candidates. the success of a medical writing apprentice program could depend on the quality of the candidates selected, so it is important to recruit, screen, and identify appropriate candidates. evaluation of program success the participants in this breakout group discussed the best way(s) to evaluate the success of an apprentice program. put simply, if the purpose of an apprenticeship program is to develop a pipeline of new medical writing talent, the true measure of success of the program is the ability of the program graduates to function as fully fledged medical writers. hence, the program administrator can track the trajectory of the graduates. were they hired directly either into the company or, if not already part of the program’s plan or not feasible for those administering it, into medical writing jobs elsewhere in industry? a truly effective apprenticeship will serve as the launchpad for a medical writing career. the expectation of the apprentice program is that well-trained graduates will be able to independently work on medical writing deliverables, with the expectation that as these new writers get more experience and exposure, documents of greater complexity and/or team situations with greater complexity will be manageable. to assess a program’s success at the level of an individual apprentice, it’s critical to establish evaluators, create evaluation criteria, and estimate a timeline for program completion. competency models, such as the dia competency model, create a good starting point for goals’ conversations and well-defined expectations. in addition, at the program’s outset, the administrator and/or mentor should define the evaluation criteria and clearly communicate those with the intern. for example, if soft skills or other “intangibles” are particularly valued, those attributes should be detailed at the outset and evaluated throughout the program to provide feedback on the intern’s progression. at the completion of the apprenticeship, the level at which the company can expect the intern to perform will be contingent on the duration of the program and those prespecified goals of the apprentice and the mentor. while the apprenticeship program is ongoing, effectiveness assessments to support continuous improvement (and adaptations, when needed) can ensure the program is working toward its goal. alignment could be achieved by including feedback from multiple sources at multiple timepoints throughout the program. as this article has discussed, ongoing direct feedback to the apprentice from those interacting with the apprentice should be encouraged. in addition, the program administrator should seek feedback from team members on specific gaps they are observing. this could be as simple as providing additional training or expanding into other learning methods or even shifting into a different learning “track” if the program allows. the apprenticeship program administrator should also plan specific intervals for seeking feedback from the apprentices about the program. do they feel they are having the learning experiences and leadership opportunities that will allow them to fulfill a medical writing function upon completion? where do they perceive gaps in their knowledge or opportunities to apply it? do they feel the program prepared them for the next stages of their careers, and, if not, what was missing from the program? as this paper has addressed the business case involved in creating and executing an apprentice program, this breakout group acknowledged that while apprentice programs enhance medical writing as a profession, they carry the inherent risk that a company could train someone only to have the graduate leave following completion of training. http://www.amwajournal.org amwajournal.org 67amwa’s fourth medical writing executives forum this would have to be considered in the overall implementation of program and potentially mitigated with retention incentives, as discussed previously. overall, a robust apprentice program should include methods to evaluate the success of the program by defining specific criteria, identifying stakeholders who will provide feedback, and soliciting feedback from the apprentices throughout the program. a successful program provides adaptability and flexibility and ultimately results in an independent medical writer who demonstrates continued growth and development. conclusions after a productive session thoroughly exploring the topics and discussions described above, the forum participants outlined what a medical writing apprentice program could look like. over the next year, the amwa executives advisory council will leverage these initial discussions to build out a comprehensive amwa medical writing apprentice program framework. the goal is to provide an outline of the recommended content, structure, and duration of an apprentice program in addition to the skills and competencies achieved upon successful completion of the program. the final aim of establishing this framework is to assist companies that want to build their own program to develop the next generation of medical writers or benchmark their existing program against the industry standard. acknowledgment we thank all the forum participants for their valuable contribution to this relevant topic in the medical writing field. author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. the opinions expressed in this article are the authors’ own and are not necessarily shared by their employers or amwa. author contact: marta.mas@tfscro.com amwa live webinars tools, tips, and tricks for medical communicators. www.amwa.org/events only $20 for members can’t attend a live webinar? you won’t miss out! all registrations for live webinars include access to the recorded video in amwa online learning. http://www.amwajournal.org american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. effective writing for health care achieve your personal writing and career objectives through key core curriculum and two specialized tracks: writing for medical and scientific journals or writing for the public the public one-year certificate program apply by: april 24, 2024 program begins: may 2024 https://postgraduateeducation.hms.harvard.edu/certificate-programs/effective-writing-health-care?utm_source=amwa&utm_medium=display&utm_campaign=ewhc2025 american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. contents v38 n4 winter 2023 4 5 7 10 16 17 20 27 from the guest editor preserving ethics in a not so ethical world › julie ravo theme articles embracing cultural differences to ensure ethical publication practices › jonathan lee and blair hesp can industry-funded ce/cme be unbiased? current insights on an old question › eve j. wilson science series destigmatizing eating disorders with medical writing › melinda d. karth creative writing resonant melodies of healing: a juneteenth symphony in medicine › george ongoro freelance focus › brian bass, cathryn d. evans, and alex howson q1: how do continuing medical education/continuing education (cme/ce) medical writers balance the need for accurate scientific representation with the pressure to create content that aligns with pharmaceutical industry interests? q2: when working on manuscripts involving multiple authors, how can medical writers help manage authorship disputes and ensure fair credit allocation following ethical guidelines? q3: how can medical communicators navigate cultural and linguistic differences in a global health care context, ensuring their work is accurate and culturally sensitive? topical features the business of medical writing: communication, leadership, and corporate responsibility part 2 › joan affleck, dominic de bellis, brian bass, and jeanette m. towles the key to better regulatory writing: tell your device’s story › scott dill 42 amwajournal.org 35results of the 2022 amwa dei survey company. six percent of respondents work for a health care organization or provider, and 6% of respondents work for a nonprofit organization or professional society. five percent of respondents work for a medical device company, and the remaining 3% work for a publisher or journal office (2%) or a government agency or contractor (1%). the remaining 11% of respondents (n = 42) work for a different type of organization or client. amwa respondents’ primary work interests or focus areas were primarily regulatory writing and editing (32%; n = 127) and scientific publications (26%; n = 102). however, 10% of respondents (n = 39) listed their primary work interest/area of focus as health communication/public health/ journalism/patient education. fewer than 10% of respondents selected continuing education, publications for professional audiences, promotional writing/marketing/ advertising/public relations, medical affairs, grant proposals, and sales training as their primary work interest or focus area, and 6% of respondents selected that their primary work interest or focus area is another type of medical writing or editing. survey respondents varied in experience, but 46% (n = 193) of respondents have worked in the field from 11 to 30 years, with 23% (n = 91) working in the field from 11 to 20 years and 23% (n = 92) working in the field from 21 to 30 years. however, the percentages that do not fall into this group are still sizable, with 17% (n = 68) who have worked in the field for 0 to 2 years, 14% (n = 54) for 3 to 5 years, and 13% (n = 52) for 6 to 10 years. finally, 10% (n = 40) of respondents have worked in the field for more than 31 years. residency by far the largest group (91%; n = 360) of respondents who answered this question lived within the united states. the state with the highest number of respondents was pennsylvania (9%; n = 33), with california and north carolina also at 9% with 30 respondents each. massachusetts and texas each had 7% of respondents, or 24 respondents each. new jersey, illinois, and maryland each had 5% (with 18, 17, and 16 of respondents respectively), and 4% of respondents lived in each of colorado (n = 15), new york (n = 15), and florida (n = 13). for respondents who lived outside the united states, the most common country of residence was canada, with 50% (n = 17) of respondents. remaining numbers of respondents are too low to disclose without potentially identifying members. disability of 397 survey respondents, 17% indicated that they had a disability; the most common disabilities were chronic illness (43%), mental health condition (24%), and other (12%; details were provided on the survey but are not included to preserve the privacy and identities of the respondents). among 42 respondents who declared a disability and did not experience barriers to participation in amwa, methods of accessing amwa services included online (64.3%) (“internet,” “computer,” and “virtually”), other (14.3%), online or other electronic medium with in-person attendance (ie, hybrid) (11.9%), with help of accommodation or regulation within their own limits (7.1%), with help of assistive device (4.8%), and via mailing list (2.4%). of note, given that some respondents who answered no to having a disability responded to this question (n = 11), there appear to be amwa members interested in both online and hybrid formats in general and who would benefit from accessibility accommodations even though they may not consider themselves disabled. several respondents mentioned in their response restrictions/barriers to access, including expense (n = 2) or other barrier (n = 1). several (n = 5) respondents also indicated that although they attend virtually when they can, they wish that there were more virtual options for participation, celebrated the greater number of virtual options available in recent years, or noted limited options for virtual participation. twenty-three participants who answered that figure 1. question 14: years of experience as a medical writer and/or editor. total respondents = 397. 0 to 2 3 to 5 6 to 10 11 to 20 21 to 30 31 or more 0 10 20 30 percent responses ye ar s of e xp er ie nc e 17 14 13 23 23 10 figure 2. question 7: do you have a disability? total respondents = 395. yes 17% no 83% 34 20 editor-in-chief michael g. baker, phd guest editor julie ravo, ma managing editor rachel mosher, ma section editors progress in publications qing zhou, phd, els regulatory insights jennifer bridgers, ms, mwc science series naomi bishop, md statistically speaking thomas m. schindler, phd everyday ethics julie ravo, ma freelance focus ruwaida vakil, msc ce craft corner haifa kassis, md practical matters elizabeth kukielka, pharmd, ma, ms, mwc around the career block cecilia petrus, msc technology talk kyla ross, ms regular contributors freelance focus brian bass, mwc melissa l. bogen, els sherri bowen, ma, els lori de milto, mj cathryn d. evans gail v. flores, phd alex howson, phd phyllis minick in the service of good writing laurie endicott thomas, ma, els conscious writing crystal r. herron, phd, els editors in memoriam lori l. alexander, mtpw, els, mwc ronald j. sanchez 2023–2024 president r. michelle sauer, phd, els 2023–2024 board liaison qing zhou, phd, els 2023–2024 staff liaison shari rager, ms, cae executive director susan krug, ms, cae graphic designer amy boches, biographics editorial office: managingeditor@amwa.org. instructions for authors available at: www.amwajournal.org. advertising: contact marketing@amwa.org or (240) 239-0940. all advertising is subject to acceptance by amwa and should be for products and services relevant to professional medical communicators. amwa is not responsible for the content of advertising and does not endorse any advertiser or its products or services. subscription: the amwa journal is published quarterly. subscription is included with amwa membership. nonmember subscriptions cost is $75 per year. contact: american medical writers association, 9841 washingtonian blvd, suite 500-26, gaithersburg, md 20878. phone: (240) 238-0940; fax: (301) 2949006; email: amwa@amwa.org. the amwa journal is in the mla international bibliography and selectively indexed in the cumulative index to nursing and allied health literature (cinahl) print index and the cinahl database. the opinions expressed by authors contributing to the journal do not necessarily reflect the opinions of amwa or the institutions with which the authors are affiliated. the association accepts no responsibility for the opinions expressed by contributors to the journal. ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwa journal mission statement in support of the mission of the american medical writers association (amwa) and to advance the broader profession, the amwa journal publishes content that reflects the interests, concerns, and expertise of medical communicators. its purpose is to inform, inspire, and motivate medical communicators. m o re v38 n4 / 2023 topical features 31 value of medical writing—using the regulator’s perspective (2021 survey results) to educate and empower medical writers › lisa chamberlain james, julia forjanic klapproth, rona claire grunspan, wayne beazley, brian bass, joan affleck, julia cooper, caroline lilley, and amy wollish 34 results of the 2022 amwa dei survey › karla haack, toni willis, and jeanette towles 38 conscious writing best practices to guide decisions of authorship and author order in a research manuscript › crystal r. herron 42 original research data mining fda docket 2019-n-1482: content, sentiment, and metadata › michael j. madson and andrew madson amwa news 48 from the president › r. michelle sauer 50 introducing the 2023–2024 board of directors › r. michelle sauer 51 calendar of meetings contents http://www.amwajournal.org american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. v38 n3 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 39 the john p. mcgovern award is named in honor of john p. mcgovern and is presented to a member or nonmember of amwa to recognize a preeminent contribution to any of the various modes of medical communication. the mcgovern award is presented during amwa’s medical writing & communication conference. one of the perks of being the amwa president is selecting the recipient of the mcgovern award. i am thrilled to announce that our 2023 mcgovern award recipients are dr jessica steier and dr andrea love in recognition of their work to communicate science on social media and via their unbiased science podcast, which critically appraises available evidence on health-related topics relevant to the public in an approachable way. dr steier and dr love began their unbiased science podcast during the pandemic as a way to counter misinformation and misconceptions about covid-19. the podcast has expanded to other topics, ranging from mammograms to vaping to health and wellness trends on social media. the podcast has a substack as a permanent repository of their sources, allowing their audience to delve into the details and reliably return to content. for those of you into infographics, you should check out their unbiasedscipod instagram, which has a wealth of health-related infographics. in addition, dr steier and dr love’s work involves training the next generation of science communicators. their unbiased science team includes several interns who do research and infographic design. furthermore, dr steier and dr love have founded the unbiased science institute to improve science literacy, help people be better consumers of scientific information, and train the next generation of science communicators. the institute works with public health leaders, students in science, technology, engineering, and math, and community organizations, and its programs include education, training, and community engagement to build health and scientific literacy. although dr steier and dr love work on health issues in different ways—macro (public health) and micro (immunology/microbiology), respectively—their areas of expertise enable them to provide a comprehensive perspective on various scientific topics. please join me in congratulating our 2023 mcgovern award winners, and i hope you join me in hearing their talk at the 2023 medical writing & communication conference in baltimore. 2023 john p. mcgovern award recipients jessica b. steier, drph, pmp, and andrea c. love, phd elise eller, phd / 2022-2023 amwa president amwa news dr jessica steier is a public health scientist with expertise in public health policy, biostatistics, and advanced analytics. dr andrea love is an immunologist and microbiologist, with expertise in infectious disease immunology, cancer immunology, and autoimmunity. dr steier and dr love believe strongly in scientific education and health literacy and the translation of research for the general public, and their unbiased science podcast is devoted to the objective, critical appraisal of available evidence on science and health-related topics relevant to listeners’ daily lives. figure. dr andrea c. love (left) and dr jessica b. steier (right), cofounders of the unbiased science podcast and the unbiased science institute. http://www.amwajournal.org https://www.unbiasedscipod.com/ https://substack.com/@theunbiasedscipod https://www.instagram.com/unbiasedscipod/ https://www.unbiasedscience.org/ american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. v38 n4 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 50 article iii of the american medical writers association’s bylaws states that a board of directors (bod) will manage and control the affairs, property, and business of the organization. the bod is responsible for approving the budget, the slate of nominees for elected office, and any proposed amendments to the constitution or bylaws. it also approves committees, work groups, and task forces and fulfills such other duties as are specifically mentioned in the constitution and bylaws and as required by law. thus, the members of the bod carry considerable responsibility. in alignment with amwa bylaws, the bod includes elected officers (president, president-elect, secretary, treasurer, immediate past president), an executive director, a chair of the chapter advisory council, and at least 5 appointed at-large directors. the number of members on the bod during the governance year shall be no less than 12 and no more than 17. i am pleased to introduce the 2023–2024 bod. this group of professionals reflects characteristics of the member population and has volunteered their time and talent to meet, discuss, and take action on items as they pertain to the organization. at its september 2023 meeting, the bod approved the following individuals to serve as at-large directors for the 2023-2024 term: • joan affleck, mba, els • sarah dobney, mph • joanna pendergrass, dvm • genevieve walker, phd • jennifer minarcik, ms • katrina r. burton, bs • j. kelly byram, ms, mba, els • qing zhou, phd, els the bod also approved erik maclaren, phd, as the chair of the chapter advisory council (a voting member of the bod). amwa 2023–2024 officers: • president: r. michelle sauer, phd, els • president-elect: shawn watson, pharmd, phd, bcps, rph, bspharm • secretary: kimberly korwek, phd • treasurer: julie phelan, md, mba • immediate past president: elise eller, phd • amwa executive director: susan krug, ms, cae (ex officio, nonvoting) the 2023–2024 bod began its service on october 28, 2023, at the conclusion of the 2023 annual business meeting at the 2023 medical writing & communication conference in baltimore, maryland. the american medical writers association bylaws can be read at the following link: https://cdn.ymaws.com/www. amwa.org/resource/resmgr/about_amwa/bylaws/amwa_ bylaws_november_2017.pdf introducing the 2023–2024 board of directors r. michelle sauer, phd, els / 2023–2024 amwa president amwa news http://www.amwajournal.org https://cdn.ymaws.com/www.amwa.org/resource/resmgr/about_amwa/bylaws/amwa_bylaws_november_2017.pdf https://cdn.ymaws.com/www.amwa.org/resource/resmgr/about_amwa/bylaws/amwa_bylaws_november_2017.pdf https://cdn.ymaws.com/www.amwa.org/resource/resmgr/about_amwa/bylaws/amwa_bylaws_november_2017.pdf https://cdn.ymaws.com/www.amwa.org/resource/resmgr/about_amwa/bylaws/amwa_bylaws_november_2017.pdf https://cdn.ymaws.com/www.amwa.org/resource/resmgr/about_amwa/bylaws/amwa_bylaws_november_2017.pdf v38 n4 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 48 to the amwa membership, i want to begin my first article as president with thanks. thank you to the membership and the nominating committee for their trust; it places me in a state of grace. shortly after being hired at uthealth in 2009, i joined the american medical writing association, and that is where i found “my people.” in this community, i have grown as a professional and as a human because of the amazing people who volunteer their time and expertise to this organization. i have been mentored by incredibly talented individuals, and i am honored to have served at the chapter and national level. i am now truly excited to begin my term as your president. as i start my term, i am reminded of how diverse amwa is. we are not one thing. we are editors, writers, and graphic artists. we are in regulatory, in academia, in education. we span the continent and the globe. in fact, even as individuals we are not one thing; often our work and experience allows us or forces us to be 5 things at once. this internal diversity is a strength, and it fosters the breath of education that amwa is able to offer. as an organization, we aim to understand and harness our diversity to enable an inclusive and equitable environment. we want every member to feel welcomed by amwa, and i am very thankful for the volunteers of the diversity and inclusion assessment task force, led by dr gail v. flores, who gathered and analyzed member data and survey results focused on this topic. i am also appreciative to the amwa staff and board members who have dedicated considerable time this past year to see and define the amwa way of diversity, equity, and inclusion (dei). to pursue our mission of promoting excellence in medical communication, we must be fearless. we will continue to recruit and retain members with a variety of backgrounds, experiences, and expertise. in the year ahead, i hope to see the formation of a special dei committee that will support the board of directors (bod)’s initiatives to foster the organization’s strategic growth. education is the heart of amwa, and as the work to ensure fantastic conferences and online learning continues, i am thankful for the members and leaders within the education committee who have been diligently working to ensure timely webinars, updated workshops, and new certificates. i am also excited to see the launch of the health communication task force; its work will bring honor to lori l. alexander’s legacy. with the growth in the medical communication field, there has also been a greater need for medical communication education programs. amwa has focused considerable time and effort into education offerings for the full spectrum of medical communicators, and these offerings will continue to expand and be refined. from the president r. michelle sauer, phd, els / 2023-2024 amwa president amwa news http://www.amwajournal.org amwajournal.org 49article title one of the growing needs of our membership is education and guidance regarding artificial intelligence (ai). medical communicators will need to adapt, evolve, and find an ethical path forward. new rules and guidance may need to be established and updated to meet the changes and opportunities brought about by ai. recent blogs on ai and authorship are available on the amwa website, and many of the sessions at the annual conferences are excellent resources. i look forward to working with leaders to build upon these initial efforts. at the same time, criticism of our profession has once again surfaced in the peer-reviewed literature. although some throw rocks at things that shine, it is our job to do more than shake it off. i look forward to working with the bod and subject matter experts in ai and in medical communication ethics so that we continue to assess and meet the needs of our membership. we will protect our reputations and identify and build needed tools. as we look to the future, i want to pause and think about how we got here. if you met me 20 years ago, you would meet a graduate student who was determined to make a contribution to this world. within 5 years, i was a postdoc with burnout. fortunately, around that time, a grad school friend invited me to join their medical writing team, and that is when i found “my thing.” i left the bench and upgraded my laptop. although i have held many different titles (assistant professor, senior research scientist, research liaison), my favorite professional title is medical communicator. although many of you have similar stories of winding paths to find this unique career niche, some of you have graduated from programs specifically designed to train medical communicators. although our field and our education continue to evolve, amwa has consistently been there to lead medical communication professionals, and i hope we are all dedicated to continuing that mission. the year ahead will be busy. we will add and refine educational content, we will grow in numbers and diversity, and we will overcome obstacles and increase equity with innovative solutions. the goals i’ve outlaid are possible because of the incredible board members, chairs, committees, staff, and volunteers. as a member, i ask each of you to find a way to connect with amwa. attend a local chapter event, offer to join a committee, or share your expertise on engage or through a journal article. it is going to be a great year ahead. are you ready for it? author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: michelle@rnaeditingllc.com new rules and guidance may need to be established and updated to meet the changes and opportunities brought about by ai. general principles of word usage www.amwa.org/online_learning choose the right word for accuracy and clarity. http://www.amwajournal.org listen to our podcast available on apple podcasts, google podcasts, and spotify become a medical writing master visit us at trilogywriting.com writers@trilogywriting.com www.trilogywriting.com/trilotalk think you have what it takes to join a world-leading team of medical writers? we’d love to speak with you. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. v39 n3 / 2024 ©2024 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 25 crystal r. herron, phd, els / redwood ink, llc, san rafael, ca the essential elements of the discussion section of a research manuscript conscious writing abstract many medical writers believe that the discussion is the most difficult section of a research manuscript to write, largely because of its structural flexibility and open-ended nature. however, medical writers can build confidence in writing this section by ensuring that the discussion includes the essential elements: a summary of the major findings, interpretations of the important findings, descriptions of the implications and applications of the findings, a discussion of the strengths and limitations of the study, details about recommended future directions, and statements of the significance and relevance of the work. these essential elements help to form an effective discussion that showcases the study and highlights its impact to the field. many medical writers believe that the discussion section of a research manuscript is the most difficult section to write. this difficulty is related to several factors. first, the discussion describes the authors’ interpretations of the findings, which requires careful thought and presentation. also, the discussion needs to explain these interpretations in the context of what is known in the field, which requires a thorough analysis of the literature and consideration of how the findings connect to that literature. furthermore, the discussion section does not follow a standard structure, which gives medical writers more creative freedom in writing this section. although this creative freedom might be liberating for some medical writers, others may feel anxiety or even dread. although the discussion is the hardest section to write, medical writers can find solace with recommendations on the essential elements to include in this section (box). these recommendations are not prescriptive nor exhaustive, but they are a solid starting point for helping medical writers feel more confident and focused in crafting an effective discussion. summarize the major findings the first paragraph of the discussion is an opportunity to transition readers from a dense results section into a discussion of the findings and interpretations. in this first paragraph, the main goal is to tie the important findings back to the study question. repeat the study question to reorient readers to the overall purpose of the study and prepare them to navigate the discussion, start with a statement that reminds them of the study question you posed at the end of the introduction. this statement should include essential elements of a discussion section summarize the major findings • repeat the study question • synthesize the most important findings • state how the findings answer the study question interpret the important findings • describe how important findings are interrelated • discuss unexpected and interesting findings • explain how important findings extend or support previous findings • explain how important findings contradict previous findings describe the implications and applications • describe the theoretical implications of the findings • describe the practical applications of the findings discuss the strengths and limitations • highlight the strengths of the study • acknowledge the limitations of the study recommend future directions • suggest next steps and future work state the conclusions and impact • repeat the main outcome • describe the main contribution to the field • emphasize the relevance and significance to the field http://www.amwajournal.org amwajournal.org 26the essential elements of the discussion section of a research manuscript the key aim(s) of the study, the main objective(s), and, when relevant, the hypothesis. synthesize the most important findings after restating the question, summarize the most important findings that answer the study question. in this summary, be careful not to rehash the findings. instead, synthesize the findings in a way that supports the answer to the study question. if the manuscript is highlighting a new approach that was developed, describe the overall approach that was developed and validated. state how the findings answer the study question at the end of this first paragraph, state how the summarized findings answer the study question. this sentence helps to tie the key findings together in a nice package that showcases how they are connected to the question and how they advance the field. interpret the important findings the bulk of the discussion includes the authors’ interpretations of the important findings and how they fit into what is known in the field. these interpretations can vary widely among studies and fields—which contributes to the common perception of the discussion being the most difficult part of a research manuscript to write. however, the following recommended features can help authors ensure they include the essential elements of an effective discussion. describe how important findings are interrelated in the discussion, describe any relationships in the findings. are there any correlations or incongruence between different findings? are there any patterns in the data? could any of the findings influence other findings? be sure to explain how these relationships could affect the outcomes or implications of the study. discuss unexpected and interesting findings although many researchers anticipate the outcomes of their work, they may still uncover surprising, intriguing, or inconclusive findings. in the discussion, describe these interesting findings and any findings that do not support the answer to the study question. importantly, share why these findings are particularly interesting and what new questions arise as a result. some examples include rationalizing unexpected outcomes, clarifying inconclusive findings, and interpreting data outliers. explain how important findings extend or support previous findings most research builds on previous work. although the introduction should describe this previous work to frame the rationale for the study, the discussion section frames how this previous work connects to the findings in the study. to discuss these connections, describe how the findings build on what is already known. for example, how do the study findings support or extend findings from previous work? explain how important findings contradict previous findings in addition to connecting the findings to previous work, the discussion should also examine any disconnections from previous work. for example, how do the study findings contradict or refute previous findings? when highlighting these disconnections, speculate on why the findings might be contradictory. for example, was the approach different? was the population or sample size different? was the analysis different? answering these questions is an opportunity to defend the work in this study and strengthen the significance of the findings. describe the implications and applications to ensure that readers fully appreciate the significance of the study, the discussion needs to include a description of the potential implications and applications of the findings. in other words, how do the findings advance the field, and what can be done now that these findings have been revealed? this description will depend on the study and generally include theoretical implications and/or practical applications. describe the theoretical implications of the findings in the discussion section, be sure to describe the theoretical implications of the findings. theoretical implications are evidence-based speculations on how the findings impact research in the field. as the name implies, these implications describe how the findings advance the field but cannot yet be meaningfully applied in the real world. describe the practical applications of the findings in the discussion section, describe any practical applications of the findings. practical applications are evidence-based recommendations or solutions that can be used in the real world. these applications are often calls to action, such as new approaches to research, changes to clinical practice, or updates to government policies. discuss the strengths and limitations the discussion section needs to highlight the strengths and limitations of the study. these details help readers to understand how definitive (ie, significant) the findings are. http://www.amwajournal.org amwajournal.org 27the essential elements of the discussion section of a research manuscript highlight the strengths of the study few journals specifically request that authors highlight the strengths of a study. and some authors feel uncomfortable or immodest about highlighting these strengths. but describing the strengths can help readers understand the value of the findings and significance of the study. when highlighting the strengths, consider all aspects of the study, including the conceptual framework, population, experimental techniques, and statistical analysis. acknowledge the limitations of the study an important part of the discussion is acknowledging the limitations of the study. be sure to describe these limitations and, importantly, how they could have affected the outcomes, interpretations, and conclusions. for example, what problems occurred? what are the weaknesses or assumptions made in the methods? what gaps does the data leave open? acknowledging these limitations gives the opportunity to share the rationale for doing the work despite the limitations or to suggest future directions of the work. recommend future directions the discussion section should include recommendations for future work. these details describe what next steps could be done to build on or fill any gaps in the work and to further advance the field. suggest next steps and future work in the discussion, describe what could be done next by the research team or others in the field. for example, if the study needed to be repeated, what could be done differently? if the study created gaps in knowledge, what could be done to fill them? if unlimited resources were available, what could be done next? state the conclusions and impact at the end of the discussion, readers have the full context of the study and how it fits into the existing literature. the conclusions paragraph is then final opportunity to highlight the significance of the work and leave readers with a lasting positive impression of the study. repeat the main outcome start by repeating the main outcome of the study, but do not summarize the findings again. repeating the main outcome reminds readers of the most important result(s) of the study. describe the main contribution to the field next, state how the main outcome answers the study question. this answer will show readers that the study accomplished its purpose of answering the question and filling a gap or need in the field. emphasize the relevance and significance to the field finally, share how the study advances the field. ending with this information highlights the relevance and significance of the work at the end of the manuscript, the prime position for leaving a lasting impact on readers. the essential elements showcase the study an effective discussion showcases the findings and significance of the study in the context of what is already known. for a medical writer, this task can be difficult and overwhelming—especially with the structural flexibility and open-ended nature of the discussion section. but with these essential elements at their fingertips, medical writers can sharpen their focus and build their confidence in crafting an effective discussion. author declaration and disclosures: the author does not have any commercial associations that may pose a conflict of interest related this article. author contact: crystal.herron@redwoodink.com http://www.amwajournal.org american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. v39 n4 / 2024 ©2024 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 48 abstract the purpose of this article is to examine the influence of social determinants of health on the global health problem of cardiovascular disease (cvd), particularly focused on the americas region. cvd, which encompasses conditions such as coronary heart disease, heart failure, and cerebral vascular disease, is identified as the leading cause of mortality worldwide, with lowand middle-income countries bearing the brunt of its burden. the article discusses how factors such as economic status, education, environment, food supply, substance addiction, and health care accessibility contribute to the prevalence of cvd. additionally, it explores current public health policies addressing cvd and provides recommendations for enhancing these policies to alleviate the burden of the disease. the recommendations include implementing tobacco control policies, raising the legal age for purchasing tobacco products, and advocating for comprehensive health care services. the article concludes by emphasizing the importance of tailored interventions, evidence-based policies, and evaluation strategies in combating cvd and improving public health outcomes. according to the world health organization,1 cardiovascular disease (cvd) is the leading cause of morbidity and mortality that affects the worldwide population. this broad category of diseases encompasses coronary heart disease, heart failure, cardiomyopathy, cerebral vascular disease, and congenital heart disease.2 atherosclerosis, characterized by the narrowing of arteries due to plaque formation, is identified as a primary underlying cause of cvd. this condition is exacerbated by chronic stress and elevated serum levels of cholesterol and triglycerides, leading to a build-up of atheroma within the coronary arteries, reducing blood supply to the myocardium, and potentially causing ischemia, myocardial infarction, and angina.2 currently, cvd accounts for 31% of the overall global deaths. however, cvd is not considered to just be a predominant health issue in developed countries; research suggests that lowand middle-income countries have a higher susceptibility to the disease, accounting for 80% of these total deaths.3 this disparity highlights the significant role that social determinants of health play in influencing cvd outcomes. economic status, education, environment, food supply, substance addiction, and accessibility to health care services are pivotal factors that shape the risk and progression of cvd. poverty and income inequality can limit access to health care services, healthy food, and education, all of which are crucial for preventing and managing cvd. lower levels of education are linked to poorer health outcomes, increased stress, and lower self-confidence, which can contribute to higher cvd risk. environmental factors, including climate change and urbanization, influence lifestyle behaviors and access to resources necessary for maintaining cardiovascular health. diets high in energy-dense, nutrient-poor foods contribute to obesity, diabetes, and other conditions that elevate cvd risk, whereas diets rich in whole grains, fruits, vegetables, and lean proteins are protective against cvd. tobacco use, excessive alcohol consumption, and illicit drug use are significant risk factors for cvd, leading to conditions such as atherosclerosis, hypertension, and cardiomyopathy. additionally, limited access to health care services hinders early detection, effective treatment, and ongoing management of cvd, particularly in smaller or economically disadvantaged nations. addressing these determinants through effective public health policies is crucial for reducing the burden of cvd, particularly in the americas. the purpose of this article is to investigate the impact of social determinants of health on the prevalence and burden of cvd in the americas. it aims to explore how economic status, education, environment, food supply, substance addiction, and health care accessibility contribute to the occurrence of cvd. additionally, the article evaluates current public health policies addressing cvd and proposes recommendations to enhance these policies to mitigate the disease’s impact in the region. current strategies include tobacco control policies, raising the legal age for purchasing alan silburn, mph, bp, bn, fawm / western sydney university, campbelltown, australia cardiovascular disease in the americas: social determinants, public health policies, and recommendations (part 1) science series http://www.amwajournal.org amwajournal.org 49cardiovascular disease in the americas (part 1) tobacco products, and advocating for comprehensive health care services. these interventions aim to mitigate the risk factors associated with cvd and improve public health outcomes. the scope of this article encompasses a comprehensive analysis of cvd within the americas, identifying and evaluating the social determinants of health that impact cvd prevalence. it provides an overview of cvds and the mechanisms through which they develop. the article examines the disparities in cvd prevalence across different economic, educational, and environmental contexts within the americas. furthermore, it reviews existing public health policies targeting cvd and offers evidence-based recommendations to improve these policies. the article concludes with insights for health education specialists and health promotion professionals, emphasizing the importance of tailored interventions, evidence-based policies, and evaluation strategies in combating cvd and enhancing public health outcomes. cvd overview cvd is a collective term that encompasses the diseases of the heart and blood vessels. it commonly includes a range of conditions such as coronary heart disease, heart failure, cardiomyopathy, cerebral vascular disease, and congenital heart disease.2 for most cvd presentations, atherosclerosis plays a pivotal role marked by arterial narrowing caused by accumulation of lipids, fibrous elements, and calcification. chronic stress, either mechanical or oxidative, can damage the inner arterial wall, facilitating the infiltration of macrophages and ldl-containing cholesterol and triglycerides. this process is expedited if serum levels are elevated. foam cell formation progresses into fatty streaks, and subsequent smooth muscle cell migration and extracellular matrix deposition lead to the formation of a fibrous plaque. if destabilized, the fibrous plaque may rupture, resulting in a thrombus and possibly coronary artery occlusion. this buildup of atheroma within the coronary arteries reduces blood supply to the myocardium, potentially causing ischemia and leading to conditions like myocardial infarction and subsequent angina.2 cvd in the americas on a global scale, cvd constitutes 31% of total mortality rates. this prevalence is similarly observed across the 21 countries in the americas, where cvd accounts for 33.7% of annual deaths, maintaining its position as the leading cause of mortality.4 broken down into 3 subregions, cvd is responsible for 22.8% of deaths in north america, 38% in latin america, and 41.8% in the non-latin caribbean. among individual countries, venezuela, guyana, and trinidad and tobago exhibit the highest cvd mortality rates, whereas canada and chile record comparatively lower rates.4 social determinants of health and cvd disparities in social determinants of health contribute to variations in health status within a country and across regions. according to the world health organization,5 the social conditions in which people are born, live, and work are shaped by the distribution of money, power, and resources at local, national, and global levels. these factors, collectively known as the social determinants of health, play a crucial role in determining an individual’s health status. key social determinants such as the environment, education, food supply, substance addiction, and lack of access to appropriate health care services significantly contribute to the burden of cvd in the americas. these determinants influence modifiable risk factors for cvd, including psychosocial stress, physical inactivity, poor diet, obesity, diabetes, smoking, and alcohol consumption.6 economic factors although cvd affects populations worldwide, significant disparities persist in its prevalence and epidemiology across countries with varying income levels. the world bank7 classifies economies based on gross national income (gni) per capita: low-income economies with a gni per capita of $995 or less, middle-income economies with a gni per capita ranging from $996 to $12,055, and high-income economies with a gni per capita of $12,056 or more.7 these income classifications delineate the economic landscape within which cvd manifests. in the americas, the economic status of a country does not necessarily correlate with the prevalence of cvd. lowincome nations such as haiti experience a substantial burden, with 24% of annual deaths attributed to cvd.7-8 similarly, middle-income countries like venezuela and guyana report significant cvd-related mortality, accounting for 30% and 33% of annual deaths, respectively.7,9,10 even higher-income countries such as canada, chile, and trinidad and tobago grapple with cvd, with reported mortality rates of 27%, 27%, and 32%, respectively.7,11-13 notably, comparing with a similarly high-income economy, australia, where cvd constitutes 29% of total annual deaths, underscores the global impact of this disease.7 economic factors significantly influence the burden of cvd. low-income countries often lack the health care infrastructure necessary for effective prevention, diagnosis, and treatment of cvd, leading to higher mortality rates. middleincome countries may experience economic instability, which can hinder health care access and affordability, http://www.amwajournal.org amwajournal.org 50cardiovascular disease in the americas (part 1) exacerbating the prevalence of cvd. in high-income countries, although health care systems are more robust, disparities within the population still exist, driven by income inequality, access to health care, and lifestyle choices. income disparities not only shape national cvd prevalence but also reveal variations within countries. for instance, in canada, regions like the renfrew and eastern counties of the champlain region exhibit higher incidences of cvd mortality compared with the city of ottawa.14,15 this disparity hints at underlying social determinants influenced by income, potentially affecting access to health care, lifestyle choices, and environmental factors. similarly, in the united states, where cvd accounts for nearly 25% of all deaths, specific regions bear a disproportionate burden. states like kentucky, west virginia, and louisiana, situated in the southern atlantic, report the highest cvd-related deaths per capita.16 these states typically have lower incomes, higher poverty rates, and limited access to health care, which hinders the prevention and effective management of cvd.17 these disparities reflect complex interplays between income, access to health care resources, education, and lifestyle factors—all of which contribute to the economic link to cvd. education likewise, to a country’s economic landscape, education is a social determinant of health because low education levels have been linked with poor health status, increased stress, and lower self-confidence.6 specifically, education has been inversely associated with cvd.18 this concept is supported by prior research designs in which individuals with lower education attainment displayed a heightened cardiovascular risk compared with those with higher levels of education.19,20 this observation may elucidate the higher occurrence of cvd in countries with lower average education attainment, such as venezuela and guyana, in contrast to countries like canada and chile.21 environment a nation’s environment refers to the natural and physical aspects of the area encompassing the climate, soil, water, and geographical position, all of which significantly influence the health determinants of the respective population. firstly, the environmental climate plays a pivotal role in daily life and is highly sensitive to changes. alterations in climate patterns can escalate the severity or frequency of health issues influenced by weather conditions, potentially leading to unforeseen health challenges in previously unaffected regions.22 the world health organization1 has highlighted the escalating global temperatures, particularly evident near the equator, as a concerning trend. such temperature rises have been linked to exacerbating preexisting cardiovascular issues like cvd due to intense heat exposure and undernutrition.23 this connection is particularly worrying because it could contribute to the surge in cvd-related hospitalizations observed in equatorial countries like brazil from 2007 to 2012.24 likewise, temperature fluctuations, especially rising temperatures, pose complex risks to cardiovascular health and nutritional well-being. intense heat exposure can strain cardiovascular systems, particularly in individuals already predisposed to cardiovascular issues.23 moreover, rising temperatures can exacerbate undernutrition by affecting agricultural productivity, food availability, and nutritional quality, thereby further compromising cardiovascular health. this dual impact underscores the intricate relation ship between environmental factors, health outcomes, and the imperative need for comprehensive approaches to address these challenges. also, a nation’s geographical location can foster psychosocial factors such as social isolation, also known as social disconnectedness. this isolation can profoundly impact an individual’s mental well-being and elevate the risk of engaging in unhealthy behaviors.25 given that health is defined as a state of complete physical, mental, and social well-being, not merely the absence of disease, mental health directly influences an individual’s vulnerability to cvd.18,26 food supply furthermore, the type of food supply and its availability can determine the health of an individual or country. evidence suggests that a poor-quality diet consisting of excessive energy-rich foods, refined grains, added sugars, high salt content, and unhealthy fats can encourage weight gain, obesity, and diabetes and can have an influence on cvd.27,28 these diets often include a high volume of processed food products that sacrifice nutrition for convenience. opposingly, a healthy diet consists of whole grains, fruits, vegetables, legumes, fish, and nuts. food supply and diets are facilitated by modern food environments that have influenced the prevalence of cvd in the americas because the food systems that were once dominated by local production and markets containing foods requiring little processing before reaching the household have shifted toward maximizing production efficiency to reduce cost and increase the convenience for the consumer, thus sacrificing the food’s nutritional value.28 substance addiction substance addiction, particularly through smoking and excessive alcohol consumption, significantly exacerbates the risk and progression of cvd. the consumption of addichttp://www.amwajournal.org amwajournal.org 51cardiovascular disease in the americas (part 1) tive substances leads individuals into cycles of dependency, often precipitated by social disintegration and stressors.29 these dependencies not only perpetuate existing health disparities among different demographic groups but also contribute significantly to the escalation of cvd. this connection is particularly notable as substance abuse can directly exacerbate risk factors associated with cvd, such as hypertension and atherosclerosis, thereby magnifying both the prevalence and severity of cardiovascular health issues within affected populations. smoking, for instance, plays a pivotal role in all phases of atherosclerosis development, a primary precursor to cvd. it triggers the release of inflammatory markers and oxidative stress, which collectively contribute to endothelial dysfunction and vascular damage. nicotine, a key component in cigarettes, further aggravates the situation by constricting blood vessels, thereby increasing blood pressure and heart rate. these physiologic changes foster the formation of arterial plaques and accelerate the progression of atheroma, narrowing crucial blood vessels and compromising blood flow to the heart and other vital organs.30 in the context of public health, substance addiction significantly adds to the prevalence of cvd. for instance, in brazil, it is known that 50% of the deaths of smokers, most of which are caused by cvd, could be prevented with smoking cessation.31 similarly, excessive alcohol consumption, defined as 3 or more drinks per day, has been linked to various cardiovascular complications, including hemorrhagic strokes, cardiomyopathy, ischemic heart disease, and hypertension. these conditions not only increase the immediate risk of cardiovascular events but also contribute to the chronic burden of cvd over time.30 this underscores the critical importance of addressing substance addiction as a key modifiable risk factor in reducing the burden of cvd globally. health care accessibility health care accessibility is not only crucial but fundamentally essential for promoting cardiovascular health across populations. access to health care services directly influences the prevention, diagnosis, treatment, and management of cvd.31 it enables widespread adoption of preventive measures such as regular screenings for risk factors like high blood pressure and cholesterol, as well as education on lifestyle changes like diet improvements and smoking cessation. timely access to health care facilities allows for early detection through diagnostic tests facilitating prompt intervention when abnormalities are identified. comprehensive treatment options, including medications, surgical interventions, and specialized cardiac rehabilitation programs, can then be implemented to manage cardiovascular conditions effectively. however, in many countries, especially those with limited health care infrastructure and resources, health care accessibility remains a significant challenge. an example of this can be witnessed in smaller countries such as saint kitts and nevis, which have a total population of 55,000, that experience challenges in providing adequate cvd health care. for instance, less than 25% of the primary health care centers in the country offer cvd risk stratification services.32 this in turn may justify the disproportionate death rates from cvd in 2021 between saint kitts and nevis when compared with the greater americas region at 278 per 100,000 and 149.9 respectively.33 access to effective and appropriate cvd health care services is vital for maintaining individual, community, and national health. it serves as a foundation for implementing successful public health policies and strategies. without sufficient access to health care, efforts to prevent and manage cvds can be significantly hampered.29 expanding on this, countries can enhance health promotion and prevention by ensuring that health care facilities offer comprehensive cvd services, including risk assessments, early detection, treatment, and ongoing management. public health campaigns can also raise awareness about the importance of regular check-ups and early intervention for cardiovascular health. incorporating these strategies into health care systems can improve cvd outcomes and contribute to overall public health. in part 2, the impact of public health policies on cvd is explored. effective public health policies create supportive environments to improve overall health by addressing social determinants like the economy, education, and health care accessibility. this section will cover the historical perspective of cvd policies, the us approach, and the effectiveness of tobacco control measures. in addition, recommendations for future actions and insights for health education specialists on designing, implementing, and evaluating interventions to prevent cvd will be presented. author statement this study did not require ethical approval as it involved a retrospective analysis of publicly available and anonymized data, with no direct involvement of human subjects. author declaration and disclosures: all individuals listed as authors participated sufficiently in the intellectual content, writing, and data analysis of the manuscript to assume public responsibility for the content therein; that all authors reviewed the final version prior to submission; and that any financial or personal relationships that might bias or be seen to bias their contributions to the work have been disclosed. author contact: alan.silburn@health.nsw.gov.au http://www.amwajournal.org amwajournal.org 52cardiovascular disease in the americas (part 1) references 1. cardiovascular diseases. world health organization. accessed october 16, 2023. https://www.who.int/health-topics/ cardiovascular-diseases#tab=tab_1 2. what we’re doing about cardiovascular conditions. australian government department of health and aged care. updated september 29, 2021. accessed september 25, 2024. https:// www.health.gov.au/topics/chronic-conditions/whatwere-doing-about-chronic-conditions/what-were-doingabout-cardiovascular-conditions?utm_source=health.gov. au&utm_medium=callout-auto-custom&utm_campaign=digital_ transformation 3. ordúñez garcía p, campillo-artero c, eds. regional consultation: priorities for cardiovascular health in the americas. key messages for policymakers. pan american health organization; 2011. accessed september 25, 2024. https://iris.paho.org/ bitstream/handle/10665.2/50952/9789275132265_eng. pdf?sequence=2&isallowed=y 4. ordunez p, prieto-lara e, pinheiro gawryszewski v, hennis a, cooper r. premature mortality from cardiovascular disease in the americas – will the goal of a decline of “25% by 2025” be met?. plos one. 2015;10(10):e0141685. 5. the determinants of health. world health organization. published february 3, 2017. accessed september 25, 2024. https://www.who.int/news-room/questions-and-answers/item/ determinants-of-health 6. gourgari e, dabelea d, rother k. modifiable risk factors for cardiovascular disease in children with type 1 diabetes: can early intervention prevent future cardiovascular events?. curr diab rep. 2017;17(12):134. 7. world bank country and lending groups. the world bank. accessed september 25, 2024. https://datahelpdesk.worldbank. org/knowledgebase/articles/906519 8. noncommunicable diseases (ncd) country profiles: haiti. world health organization; 2018. accessed september 25, 2024. https:// cdn.who.int/media/docs/default-source/country-profiles/ncds/ hti_en.pdf 9. noncommunicable diseases (ncd) country profiles: guyana. world health organization; 2018. accessed september 25, 2024. https://cdn.who.int/media/docs/default-source/countryprofiles/ncds/guy_en.pdf 10. noncommunicable diseases (ncd) country profiles: venezuela (bolivarian republic of). world health organization; 2018. accessed september 25, 2024. https://cdn.who.int/media/docs/ default-source/country-profiles/ncds/ven_en.pdf 11. noncommunicable diseases (ncd) country profiles: canada. world health organization; 2018. accessed september 25, 2024. https://cdn.who.int/media/docs/default-source/countryprofiles/ncds/can_en.pdf 12. noncommunicable diseases (ncd) country profiles: chile. world health orgnization; 2018. accessed september 25, 2024. https:// cdn.who.int/media/docs/default-source/country-profiles/ncds/ chl_en.pdf 13. noncommunicable diseases (ncd) country profiles: trinidad and tobago. world health organization; 2018. accessed september 25, 2024. https://cdn.who.int/media/docs/default-source/ country-profiles/ncds/tto_en.pdf 14. wielgosz a, jaffey j, williams k, et al. atlas of cardiovascular health in the champlain region, 2011. the champlain cardiovascular disease prevention network; 2011. accessed september 25, 2024. https://haloresearch.ca/wp-content/ uploads2/2011/07/ccpn-atlas.pdf 15. kreatsoulas c, anand s. the impact of social determinants on cardiovascular disease. can j cardiol. 2010;26 (suppl c):8c-13c. 16. heart disease facts. centers for disease control and prevention. accessed september 25, 2024. https://www.cdc.gov/heartdisease/data-research/facts-stats/index.html 17. senney gt, steckel rh. developmental origins of cardiovascular disease: understanding high mortality rates in the american south. int j environ res public health. 2021;18(24):13192. 18. mental health action plan 2013-2020. world health organization; 2013. accessed september 25, 2024. https://iris.who.int/ bitstream/handle/10665/89966/9789241506021_eng.pdf 19. strand b, tverdal a. can cardiovascular risk factors and lifestyle explain the educational inequalities in mortality from ischaemic heart disease and from other heart diseases? 26 year follow up of 50.000 norwegian men and women. j epidemiol community health. 2004;58(1)705-709. 20. kubota y, heiss g, maclehose r, roetker n, folsom a. association of educational attainment with lifetime risk of cardiovascular disease. jama intern med. 2017;177(8):1165. 21. education for all: global monitoring report. unesco; 2012. accessed september 25, 2024. https://unesdoc.unesco.org/ ark:/48223/pf0000217509 22. crimmins a, balbus j, gamble jl, et al. the impacts of climate change on human health in the united states: a scientific assessment. us global change research program; 2016. accessed september 25, 2024. http://dx.doi.org/10.7930/j0r49nqx 23. de blois j, kjellstrom t, agewall s, ezekowitz j, armstrong p, atar d. the effects of climate change on cardiac health. cardiology. 2015;131(4):209-217. 24. ribeiro a, duncan b, brant l, lotufo p, mill j, barreto s. cardiovascular health in brazil: trends and perspectives. circulation. 2016;133(4):422-433. 25. cornwell e, waite l. social disconnectedness, perceived isolation, and health among older adults. j health soc behav. 2009;50(1):31-48. 26. beyond blue. coronary heart disease, anxiety and depression. heart foundation; 2011. accessed september 25, 2024. https:// www.heartfoundation.org.au/your-heart/mental-health-andheart-disease 27. uauy r, kumanyika s, seidell j, et al. who/fao release independent expert report on diet and chronic disease. world health organization. published march 3, 2003. accessed september 25, 2024. https://www.who.int/news/item/03-032003-who-fao-release-independent-expert-report-on-diet-andchronic-disease 28. anand ss, hawkes c, de souza rj, et al. food consumption and its impact on cardiovascular disease: importance of solutions focused on the globalized food system. j am coll cardiol. 2015;66(14):1590-1614. 29. social determinants of health and the prevention of health inequities. australian medical association. march 5, 2007. accessed september 25, 2024. https://ama.com.au/positionstatement/social-determinants-health-and-prevention-healthinequities-2007 30. mukamal kj. the effects of smoking and drinking on cardiovascular disease and risk factors. alcohol res health. 2006;29(3):199-202. 31. simão af, précoma db, de andrade jp, correa filho h, saraiva jfk, de oliveira gmm; brazilian society of cardiology. cardiovascular prevention guideline of the brazilian society of cardiology executive summary. arq bras cardiol. 2014;102(5):420-431. 32. noncommunicable diseases (ncd) country profiles: saint kitts and nevis. world health organization; 2018. accessed september 25, 2024. https://cdn.who.int/media/docs/default-source/ country-profiles/ncds/kna_en.pdf 33. ihme. death rate from cardiovascular disease. our world in data. published may 20, 2024. accessed july 11, 2024. https://cdn. who.int/media/docs/default-source/country-profiles/ncds/kna_ en.pdf?sfvrsn=79154496_36&download=true http://www.amwajournal.org https://www.who.int/health-topics/cardiovascular-diseases#tab=tab_1 https://www.who.int/health-topics/cardiovascular-diseases#tab=tab_1 https://www.health.gov.au/topics/chronic-conditions/what-were-doing-about-chronic-conditions/what-were-doing-about-cardiovascular-conditions?utm_source=health.gov.au&utm_medium=callout-auto-custom&utm_campaign=digital_transformation https://www.health.gov.au/topics/chronic-conditions/what-were-doing-about-chronic-conditions/what-were-doing-about-cardiovascular-conditions?utm_source=health.gov.au&utm_medium=callout-auto-custom&utm_campaign=digital_transformation https://www.health.gov.au/topics/chronic-conditions/what-were-doing-about-chronic-conditions/what-were-doing-about-cardiovascular-conditions?utm_source=health.gov.au&utm_medium=callout-auto-custom&utm_campaign=digital_transformation https://www.health.gov.au/topics/chronic-conditions/what-were-doing-about-chronic-conditions/what-were-doing-about-cardiovascular-conditions?utm_source=health.gov.au&utm_medium=callout-auto-custom&utm_campaign=digital_transformation https://www.health.gov.au/topics/chronic-conditions/what-were-doing-about-chronic-conditions/what-were-doing-about-cardiovascular-conditions?utm_source=health.gov.au&utm_medium=callout-auto-custom&utm_campaign=digital_transformation https://www.health.gov.au/topics/chronic-conditions/what-were-doing-about-chronic-conditions/what-were-doing-about-cardiovascular-conditions?utm_source=health.gov.au&utm_medium=callout-auto-custom&utm_campaign=digital_transformation https://iris.paho.org/bitstream/handle/10665.2/50952/9789275132265_eng.pdf?sequence=2&isallowed=y https://iris.paho.org/bitstream/handle/10665.2/50952/9789275132265_eng.pdf?sequence=2&isallowed=y https://iris.paho.org/bitstream/handle/10665.2/50952/9789275132265_eng.pdf?sequence=2&isallowed=y https://www.who.int/news-room/questions-and-answers/item/determinants-of-health https://www.who.int/news-room/questions-and-answers/item/determinants-of-health https://datahelpdesk.worldbank.org/knowledgebase/articles/906519 https://datahelpdesk.worldbank.org/knowledgebase/articles/906519 https://cdn.who.int/media/docs/default-source/country-profiles/ncds/hti_en.pdf https://cdn.who.int/media/docs/default-source/country-profiles/ncds/hti_en.pdf https://cdn.who.int/media/docs/default-source/country-profiles/ncds/hti_en.pdf https://cdn.who.int/media/docs/default-source/country-profiles/ncds/guy_en.pdf https://cdn.who.int/media/docs/default-source/country-profiles/ncds/guy_en.pdf https://cdn.who.int/media/docs/default-source/country-profiles/ncds/ven_en.pdf https://cdn.who.int/media/docs/default-source/country-profiles/ncds/ven_en.pdf https://cdn.who.int/media/docs/default-source/country-profiles/ncds/can_en.pdf https://cdn.who.int/media/docs/default-source/country-profiles/ncds/can_en.pdf https://cdn.who.int/media/docs/default-source/country-profiles/ncds/chl_en.pdf https://cdn.who.int/media/docs/default-source/country-profiles/ncds/chl_en.pdf https://cdn.who.int/media/docs/default-source/country-profiles/ncds/chl_en.pdf https://cdn.who.int/media/docs/default-source/country-profiles/ncds/tto_en.pdf https://cdn.who.int/media/docs/default-source/country-profiles/ncds/tto_en.pdf https://haloresearch.ca/wp-content/uploads2/2011/07/ccpn-atlas.pdf https://haloresearch.ca/wp-content/uploads2/2011/07/ccpn-atlas.pdf https://www.cdc.gov/heart-disease/data-research/facts-stats/index.html https://www.cdc.gov/heart-disease/data-research/facts-stats/index.html https://iris.who.int/bitstream/handle/10665/89966/9789241506021_eng.pdf https://iris.who.int/bitstream/handle/10665/89966/9789241506021_eng.pdf https://unesdoc.unesco.org/ark:/48223/pf0000217509 https://unesdoc.unesco.org/ark:/48223/pf0000217509 http://dx.doi.org/10.7930/j0r49nqx https://www.heartfoundation.org.au/your-heart/mental-health-and-heart-disease https://www.heartfoundation.org.au/your-heart/mental-health-and-heart-disease https://www.heartfoundation.org.au/your-heart/mental-health-and-heart-disease https://www.who.int/news/item/03-03-2003-who-fao-release-independent-expert-report-on-diet-and-chronic-disease https://www.who.int/news/item/03-03-2003-who-fao-release-independent-expert-report-on-diet-and-chronic-disease https://www.who.int/news/item/03-03-2003-who-fao-release-independent-expert-report-on-diet-and-chronic-disease https://ama.com.au/position-statement/social-determinants-health-and-prevention-health-inequities-2007 https://ama.com.au/position-statement/social-determinants-health-and-prevention-health-inequities-2007 https://ama.com.au/position-statement/social-determinants-health-and-prevention-health-inequities-2007 https://cdn.who.int/media/docs/default-source/country-profiles/ncds/kna_en.pdf https://cdn.who.int/media/docs/default-source/country-profiles/ncds/kna_en.pdf https://ourworldindata.org/grapher/cardiovascular-disease-death-rates https://ourworldindata.org/grapher/cardiovascular-disease-death-rates american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. solve common headaches when reviewing documents in microsoft 365, veeva vault, google docs and more… key integrations: trusted by: 85% of the top 25 global pharma 4 out of the top 5 cros 4 out of the top 5 medical device companies learn more: go.ideagen.com/ amwa-learn-more-pleasereview https://www.ideagen.com/solutions/document-collaboration/life-sciences-pleasereview?utm_source=amwa+journal+&utm_medium=referral&utm_term=learn-more&utm_content=amwa-journal-advert-1&utm_campaign=fy25-all-comp-plr-gen-amwa-newsletter-ad american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. v38 n4 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 51 international society for medical publication professionals “2024 european meeting of ismpp” january 23-24, 2024 london, uk https://www.ismpp.org/european-meeting alliance for continuing education in the health professions “the alliance 2024 annual conference” february 5-8, 2024 new orleans, la https://www.acehp.org/registration american association for the advancement of science “toward science without walls” february 15-17, 2024 denver, co https://meetings.aaas.org/ regulatory affairs professionals society “raps global regulatory strategy conference” march 5-7, 2024 linthicum heights, ma https://www.raps.org/events/raps-global-regulatory-strategyconference-2024 drug information association “dia europe 2024” march 12-14, 2024 brussels, belgium https://www.diaglobal.org/en/flagship/dia-europe-2024 american copy editors society/aces: the society for editing “aces 2024 san diego: unleashing creativity” april 4-6, 2024 san diego, ca https://aceseditors.org/conference/2024-san-diego-1 the association of clinical research professionals “acrp 2024” may 3-6, 2024 anaheim, ca https://acrpnet.org/event/acrp-2024/ council of science editors “2024 cse annual meeting” may 4-7, 2024 portland, or https://www.councilscienceeditors.org/annual-meeting european medical writers association “valencia 2024” may 7-10, 2024 valencia, spain https://www.emwa.org/conferences/future-conferences/ society for scholarly publishing “inflection point: setting the course for the future of scholarly communication” may 29-31, 2024 boston, ma https://customer.sspnet.org/ssp/ssp/am24/home.aspx drug information association “dia 2024 global annual meeting” june 16-20, 2024 san diego, ca https://www.diaglobal.org/en/flagship/dia-2024 calendar of meetings http://www.amwajournal.org https://www.ismpp.org/european-meeting https://www.acehp.org/registration https://meetings.aaas.org/ https://www.raps.org/events/raps-global-regulatory-strategy-conference-2024 https://www.raps.org/events/raps-global-regulatory-strategy-conference-2024 https://www.diaglobal.org/en/flagship/dia-europe-2024 https://aceseditors.org/conference/2024-san-diego https://acrpnet.org/event/acrp-2024/ https://www.councilscienceeditors.org/annual-meeting https://www.emwa.org/conferences/future-conferences/ https://customer.sspnet.org/ssp/ssp/am24/home.aspx https://www.diaglobal.org/en/flagship/dia-2024 https://www.raps.org/events/regulatory-intelligence-conference american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. v38 n4 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 31 abstract in 2021, an american medical writers association (amwa) working group conducted a survey to gain an understanding of how regulatory agencies perceive the value of medical writing. the survey showed that document quality is extremely important to the timely and efficient review of an application and identified key factors affecting document quality that negatively impact application approval. in response to this, a working group ran a series of roundtables at the amwa and european medical writers association conferences to gather opinions from medical writers about this survey and how we can best communicate these ideas to authoring teams. this article discusses the feedback obtained in those roundtable sessions and presents the working group’s proposal for a set of resources to empower medical writers to implement change. introduction medical writers bring value across the health sciences, driving efficient approaches for the delivery of high-quality medical communication documents targeted at diverse audiences including regulators, payors, physicians, and patients.1–3 the results of the american medical writers association (amwa) 2021 regulators survey3 demonstrated that regulatory reviewers recognize the value of medical writers in the preparation of regulatory documents submitted to obtain new drug approvals worldwide. of the regulators surveyed, 70% agreed or strongly agreed that medical writers improve the quality of documents, and 87% agreed or strongly agreed that sponsor companies with established medical writing functions and rigorous document development processes and standards produce higher quality submissions. importantly, 87% confirmed that poor document quality impedes regulatory assessment, and 77% of the regulatory reviewers agreed or strongly agreed that poor document quality delays the approval process. thus, the impact of poorly written documents can be substantial. the survey showed that poor document quality negatively affects the applicant’s goals, which in most cases would be the approval of a drug or expansion of indication. when the regulators were asked which one document quality issue they encounter most frequently, the 3 top answers were excessive length/repetition/verbosity, poor explanation of rationale, and nonadherence to guidance. these are all things that medical writers can have a direct impact on if their authoring teams agree to using common ideas considered to be good medical writing practice (eg, lean writing and effective review processes). the current working group was formed to educate medical writers about the importance of these regulator-conveyed issues with document quality and to empower writers by proposing evidence-based resources they can use to advise and convince their authoring teams about what good medical writing practice is and why it is essential for successful regulatory documents. educating and empowering medical writers the survey revealed that regulatory reviewers appreciated and recognized the contributions and value of trained medical writers. the amwa value of medical writing workstream focusing on the regulator’s perspective concluded that “training must equip medical writers to lead teams that create documents that are concise and clearly present the messages supported by the data.”4 moreover, recognizing the regulator’s appreciation for the medical writer’s contribution is a powerful tool to guide the industry toward more streamlined writing practices that will ultimately aid and streamline drug approvals. making the writing community and their teams aware of this feedback should be a priority for the profession. lisa chamberlain james,1 julia forjanic klapproth,2 rona claire grunspan,3 wayne beazley,4 brian bass,5 joan affleck,6 julia cooper,7 caroline lilley,8 and amy wollish9 / 1trilogy writing and consulting, cambridge, uk; 2trilogy writing and consulting, frankfurt, germany; 3medical writing, icon plc, leawood, ks; 4medical writing, astellas, northbrook, il; 5bass global inc, fort myers, fl; 6medical writing, merck and co, inc, rahway, nj; 7global medical writing services, parexel international (irl) limited, dublin, ireland; 8regulatory writing, amgen, thousand oaks, ca; 9medical writing, jazz pharmaceuticals, palo alto, ca value of medical writing—using the regulator’s perspective (2021 survey results) to educate and empower medical writers topical feature http://www.amwajournal.org amwajournal.org 32using the regulator’s perspective to educate and empower medical writers to this end, the data from the amwa value of medical writing workstream were presented at roundtable sessions at the european medical writers association conference in may 2022 and the amwa conference in november 2022. the medical writers who participated in the roundtables were informally surveyed to assess what their opinions were about the survey results. we also sought their input on how they thought a set of resources would help to implement change in the specific areas of improvement identified and what they felt would be useful to include in such a set. the feedback from these sessions was formative for developing the concept of the set of resources to help implement change. the key ideas are summarized below. first and foremost, it was recognized that the medical writing community needs to be made more aware of the 2021 article. of approximately 20 medical writers who attended the roundtable sessions, only 2 had read the article and were aware of it prior to the session. this made it clear that there is a very low awareness of the article among medical writers. there was general consensus that, for people to actively use a set of resources based on the data from the article, they need to be well-versed in the upstream survey and results. beyond that, we asked for input on what participants felt a set of resources should be to aid in educating their teams. based on the responses, it was understood that the resources should provide material to help medical writers understand and raise awareness about the following key topics: • having a clear, strategic presentation of rationale • streamlining the writing process • demonstrating value for management from using good medical writing practices to help teams understand the need and methodology for a clear, strategic presentation of rationale, the set of resources should • provide examples and arguments for explaining the rationale for study design and in-text data selection, • present arguments for having the medical writer actively participate in kickoff and strategy meetings and lead comment resolution meetings, and • describe and explain how professional reviewers review documents. to help with streamlining the writing process, the set of resources should • present arguments that a medical writer can share with their team to support the use of lean writing and demonstrate that it is not necessary to repeat all the data in text (eg, the regulators clearly expressed a preference for lean and concise writing; lean writing needs less quality control time), • contain examples of what non-lean writing looks like compared with lean writing and include simple examples of how streamlining the language can be achieved, and • provide a list of good writing practices based on the results. to demonstrate value for management, the set of resources should provide arguments that can be used to convince management of the importance of well-written, lean documents. in addition, the participants of the roundtable sessions felt that the set of resources should be useable for training medical writers and include visual aids that can be embedded in other materials. ultimately, the goals of the set of resources are to raise awareness and highlight the importance of • delivering succinct documents with clear and concise reporting of results and messaging, • educating teams on how professional reviewers review documents, and • empowering medical writers to act as strategists and key drivers of their documents. the topics associated with these goals are outlined in table 1 on the next page. based on this, a set of resources will be created comprising a set of documents and slides that can be used with different audiences, depending on the setting and document types. we hope that disseminating this set of resources will help spread the important message of the regulators survey and give medical writers effective arguments to show their teams that by applying good medical writing practice to reduce length/repetition/verbosity, increase clarity, and provide a better explanation of rationale, we can accelerate the drug approval process and deliver medicines to patients faster. author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. the opinions expressed in this article are the authors’ own and are not necessarily shared by their employers or amwa. author contact: lisa@trilogywriting.com references 1. marchington jm, burd gp. author attitudes to professional medical writing support. curr med res opin. 2014;30(10):2103-2108. 2. forjanic klapproth j. strategic medical writing: why settle for less. pharm phys. 2012;22(6):20-24. 3. limaye n. medical writing: the language and art of scientific communication. global forum. published 2020. accessed october 4, 2023. https://globalforum.diaglobal.org/issue/ may-2020/medical-writing-the-language-and-art-of-scientificcommunication/ 4. cooper j, chamberlain james l, affleck j, bass b, forjanic klapproth j, harris d. value of medical writing: the regulator’s perspective. amwa j. 2021;36(4):145-151. http://www.amwajournal.org https://globalforum.diaglobal.org/issue/may-2020/medical-writing-the-language-and-art-of-scientific-communication/ https://globalforum.diaglobal.org/issue/may-2020/medical-writing-the-language-and-art-of-scientific-communication/ https://globalforum.diaglobal.org/issue/may-2020/medical-writing-the-language-and-art-of-scientific-communication/ amwajournal.org 33using the regulator’s perspective to educate and empower medical writers table 1. goals and topics of the resources set for medical writers goals of the resources set resources set topics delivering succinct documents with clear and concise reporting of results and messaging good writing practices how to avoid poor explanation of rationale and unclear key messaging removing repetition: give examples increasing the use of cross-referencing both within and between documents using succinct bulleted lists or tables to convey key information, as appropriate, instead of long paragraphs contemporary abbreviation rules (not defining at first use: explain how this saves time in multiple areas) reducing excessive length the value of using a single template for study reports and other documents (for uniform structure and data presentation) educating teams on how professional reviewers review documents if time is of the essence, what should the team focus on first to ensure the document will help them easily find the answers to the questions they have—what are the key messages, and have we made sure a reviewer sees these in each section? help teams understand the importance of effective cross-referencing to guide reviewers to supporting information. giving the assessors the messages in succinct text that aids them to prepare their assessment reports. if they do not have to slog through writing those reports from scratch and can copy over well-written text that has clear messages, it can save days of time in completing the assessment. empowering medical writers to act as strategists and key drivers of their documents mw is present at kickoff and strategy meetings so they properly understand the rationale behind the messaging: only in this way can they effectively communicate the message. mw should lead the comment resolution meetings—they know best where the unanswered questions are in the document and where there are gaps that need filling. mw should be proactive in referring to relevant guidances, agency websites, and primary source references to tailor and suggest text within the dossier. provide a strong argument for explaining the rationale for selection of the data. the mw should have a clear vision of how the data work together to build the overall story—and should advise the team on optimal ways of presenting these data (in figures, tables, text) to best communicate the flow of logic that leads to the conclusions. clarification of roles on teams: no one person owns the content of a document; there is a team of authors who all contribute to a document. yet, the medical writer owns the master version of the file and is responsible for making sure comments are all addressed and applied consistently throughout. there cannot be a free-for-all, or the mw will lose oversight of document integrity and what has been changed. mw, medical writer. http://www.amwajournal.org american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. contents v40 n1 spring 2025 4 5 10 12 14 16 18 19 21 23 25 27 29 34 from the editor › michael g. baker conference award 2024 john p. mcgovern award address: communicating with diverse communities › nadya merchant conference session reports next-level qc review and editing in medical writing › mary anne loafman developing standard and graphical abstracts for publications › kyla ross do this, not that! tips and tricks for using large language models successfully › eva stabenow how to make marketing your freelance business as easy as tying your shoes › lori de milto let’s talk about the medical copywriter’s role in health care advertising › milly vega navigating oncology: expert strategies for effective medical writing › padmapriya padmanabhan news and public relations writing for medical and health communicators › sidonie jones storytelling with clinical data: how to write readable clinical evaluation reports › sidonie jones updated guidance on inclusive language for science writers and editors › kerry kennedy digital tools for freelance writers and editors › shanzeh mumtaz ahmed topical features developing new talent in regulatory medical writing: amwa apprentice program framework › kimberly jochman, andriana papaconstantinou, angela burnett, brian geldziler, janice worley, jeanette towles, joan affleck, julia cooper, julia forjanic klapproth, keisha smith, laura sheppard, lynne munno, rona claire grunspan, and zhiming zhang, on behalf of the amwa apprentice program framework working group pathways to medical writing: short-term opportunities to jumpstart your career › jeanette m. towles and jason s. casavant 0% 10% 20% 30% 40% 50% 60% 70% 80% external hard-drive flash drive/usb keys/sacks online/cloud-based service other no back-up 65% 31% 52% 7% 6% 52% 19% 64% 10% 5% 39% 12% 75% 2% 5% 2016 survey (n=307) 2018 survey (n=262) 2024 survey (n=291)39 34 5 editor-in-chief michael g. baker, phd managing editor rachel mosher, ma section editors progress in publications qing zhou, phd, els regulatory insights jennifer bridgers, ms, mwc science series naomi bishop, md statistically speaking thomas m. schindler, phd everyday ethics julie ravo, ba, ma freelance focus ruwaida vakil, msc ce craft corner haifa kassis, md practical matters elizabeth kukielka, pharmd, ma, ms, mwc around the career block cecilia petrus, msc technology talk kyla ross, bs, ms regular contributors freelance focus brian g. bass, mwc melissa l. bogen, els sherri bowen, ma, els lori de milto, mj cathryn d. evans gail v. flores, phd alex howson, phd phyllis minick in the service of good writing laurie endicott thomas, ma, els conscious writing crystal r. herron, phd, els editors in memoriam lori l. alexander, mtpw, els, mwc ronald j. sanchez 2024–2025 president roshawn (shawn) watson, pharmd, phd, bcps 2024–2025 board liaison jennifer minarcik, ms 2024–2025 staff liaison shari rager, ms, cae executive director susan krug, ms, cae graphic designer amy boches, biographics editorial office: managingeditor@amwa.org. instructions for authors available at: www.amwajournal.org. advertising: contact marketing@amwa.org or (240) 239-0940. all advertising is subject to acceptance by amwa and should be for products and services relevant to professional medical communicators. amwa is not responsible for the content of advertising and does not endorse any advertiser or its products or services. subscription: the amwa journal is published quarterly. subscription is included with amwa membership. nonmember subscriptions cost is $75 per year. contact: american medical writers association, 9841 washingtonian blvd, suite 500-26, gaithersburg, md 20878. phone: (240) 238-0940; fax: (301) 2949006; email: amwa@amwa.org. the amwa journal is in the mla international bibliography and selectively indexed in the cumulative index to nursing and allied health literature (cinahl) print index and the cinahl database. the opinions expressed by authors contributing to the journal do not necessarily reflect the opinions of amwa or the institutions with which the authors are affiliated. the association accepts no responsibility for the opinions expressed by contributors to the journal. ©2025 american medical writers association. all rights reserved. issn 2163-5315 amwa journal mission statement in support of the mission of the american medical writers association (amwa) and to advance the broader profession, the amwa journal publishes content that reflects the interests, concerns, and expertise of medical communicators. its purpose is to inform, inspire, and motivate medical communicators. m o re v40 n1 / 2025 39 original research how freelance medical writers and editors use digital tools: results from the 2024 freelance medical communicator tools of the trade survey › monica nicosia 52 ce craft corner learning in the digital age: the rise of social media in continuing education › morgan leafe 56 freelance focus jam session for seasoned freelancers in new orleans › brian g. bass amwa news 58 from the president–inaugural address catch the vision › shawn watson 59 taking ai technology out of the box: amwa’s sixth medical writing executives’ forum › janice worley, jeanette towles, jeannene butler, lisa chamberlain james, shiri diskin, julia forjanic klapproth, nika matzke, robyn pierce, and tatyana wanderer 66 calendar of meetings contents http://www.amwajournal.org american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. less time navigating regulations means more time innovating. medical & technical writing medical affairs & comms pharmacovigilance clinical science & operations project management nonclinical strategy & writing cmc strategy & writing quality assurance regulatory it technology services learn more at synterex.com or � nd us on https://synterex.com/ american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. contents v40 n3 fall 2025 from the guest editor › ben riggs theme articles artificial intelligence bias in health communication: risks and strategies for medical writers › red thaddeus d. miguel, manal el joumaa, and rami ali the power and peril of metaphor in health communication › ben riggs trust, artificial intelligence–generated images, and health communication policy › abbie miller around the career block medical writing academy: fostering cross-functional expertise and professional growth › pinki rajeev, julia cooper, linda yih, roopa basrur, sandhya prabhu, saxon whittle, sheelah smith, and tarranum jaspal conscious writing strategies for turning fruitless feedback lectures into “giftful” discussions › crystal r. herron freelance focus › brian bass, melissa l. bogen, and cathryn d. evans q1: how do you handle unexpected expenses or income fluctuations in your freelance business? what financial strategies do you employ to maintain stability? q2: how do you handle conflicts of interest when working with multiple clients in the same therapeutic area or with competing companies? q3: what are the most common financial mistakes you’ve made as a freelancer, and what lessons have you learned from them? in the service of good writing my like-hate relationship with word’s grammar checker › laurie endicott thomas science series section editor's note › naomi bishop incretin drug revolution: the challenges of hope › alicia racellis 49 35 14 3 4 10 14 19 24 28 31 34 35 editor-in-chief michael g. baker, phd managing editor rachel mosher, ma guest editor ben riggs section editors around the career block cecilia petrus, msc ce craft corner haifa kassis, md everyday ethics julie ravo, ba, ma freelance focus ruwaida vakil, msc global medical communication thomas m. schindler, phd practical matters elizabeth kukielka, pharmd, ma, ms, mwc progress in publications qing zhou, phd, els regulatory insights kimberly jochman, phd, rac science series naomi bishop, md technology talk kyla ross, bs, ms regular columns conscious writing crystal r. herron, phd, els(d) in the service of good writing laurie endicott thomas, ma, els regular contributors freelance focus brian g. bass, mwc melissa l. bogen, els sherri bowen, ma, els lori de milto, mj cathryn d. evans gail v. flores, phd alex howson, phd phyllis minick editors in memoriam lori l. alexander, mtpw, els, mwc ronald j. sanchez 2024–2025 president roshawn (shawn) watson, pharmd, phd, bcps 2024–2025 board liaison jennifer minarcik, ms 2024–2025 staff liaison shari rager, ms, cae executive director susan krug, ms, cae graphic designer amy boches, biographics editorial office: managingeditor@amwa.org. instructions for authors available at: www.amwajournal.org. advertising: contact marketing@amwa.org or (240) 239-0940. all advertising is subject to acceptance by amwa and should be for products and services relevant to professional medical communicators. amwa is not responsible for the content of advertising and does not endorse any advertiser or its products or services. subscription: the amwa journal is published quarterly. subscription is included with amwa membership. nonmember subscriptions cost is $75 per year. contact: american medical writers association, 9841 washingtonian blvd, suite 500-26, gaithersburg, md 20878. phone: (240) 238-0940; fax: (301) 2949006; email: amwa@amwa.org. the amwa journal is in the mla international bibliography and selectively indexed in the cumulative index to nursing and allied health literature (cinahl) print index and the cinahl database. the opinions expressed by authors contributing to the journal do not necessarily reflect the opinions of amwa or the institutions with which the authors are affiliated. the association accepts no responsibility for the opinions expressed by contributors to the journal. ©2025 american medical writers association. all rights reserved. issn 2163-5315 amwa journal mission statement in support of the mission of the american medical writers association (amwa) and to advance the broader profession, the amwa journal publishes content that reflects the interests, concerns, and expertise of medical communicators. its purpose is to inform, inspire, and motivate medical communicators. m o re v40 n3 / 2025 42 science series treating pain: the unintended journey from relief to desperation › nadia sabeva amwa news 47 from the president › roshawn (shawn) watson 48 2025 amwa fellows › loretta bohn 50 2025 walter c. alvarez award recipient: jen gunter, md › mary ellen shepard 51 2025 golden apple award recipient: andrea gwosdow, phd › loretta bohn 52 2025 john p. mcgovern award recipient: scott ratzan, md, mpa › roshawn (shawn) watson 53 2025 amwa president’s award recipient: theresa singleton, phd › roshawn (shawn) watson 54 amwa’s health communication certificate program is coming! › emily viles-monari and genevieve walker 56 officer candidate slate for the 2025-2026 election › kimberly korwek 58 calendar of meetings contents http://www.amwajournal.org american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. v40 n3 / 2025 ©2025 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 35 abstract over 800 million people worldwide meet the criteria for obesity, highlighting the need for safe and effective treatments. recent advances reshaped the paradigm of adipose as an organ that regulates hunger, satiety, insulin sensitivity, and inflammation. clinical obesity is a chronic condition linked to excess visceral adipose in which the health risk has already manifested. this definition reflects our understanding of obesity, rather than relating it to body size, weight-based conditions, or elevated body mass index. clinical guidelines recommend pharmacotherapy for children and adults meeting the criteria for obesity. because few independent diverse trials compare obesity drugs, doctors must resort to trial-and-error to predict usefulness. and the lack of diversity may impact drug safety for at-risk populations. for example, black and hispanic adults are at the highest risk for obesity, but few participated in drug trials. the discovery of incretins led to incretin-based hormone drugs that bind glucagon-like peptide-1 or glucose-dependent insulinotropic polypeptide receptors. the media attention around these repurposed type 2 diabetes drugs brings hope for obesity treatment in clinical practice. manufacturers market incretin drugs as a panacea for neurological, metabolic, and cardiovascular conditions. filling a unique therapeutic gap between lifestyle modification and bariatric surgery, incretin drugs may help some people. yet, with any medication, balancing benefits and risks optimizes health. thus, long-term safety studies comparing incretin drugs in a diverse population are needed for the development of safe and effective treatments. understanding the health benefits after bariatric surgery, drug therapy, and combination therapy may help guide future clinical practice. a magical remedy to control human metabolism has evaded scientists for over 130 years. since the nineteenth century, manufacturers have sold various weight-lowering tonics, banned from sale because of safety issues. as the philosopher santayana said, “those who cannot remember the past are condemned to repeat it.” and predictably, without understanding the underlying cause for adipose dysfunction or correcting past clinical trial design flaws, manufacturers continue to develop risky treatments for obesity—a controversial word defined by the centers for disease control and prevention (cdc) as a body mass index (bmi) of 30 or more. since the us food and drug administration (fda) began regulating drugs in 1938, manufacturers have failed to produce safe and effective medicines to regulate metabolism.1 amphetamines and sympathomimetic drugs led to abuse, cardiac damage, suicidality, cancer, and even death (figure 1).2 with over 800 million people worldwide meeting criteria for obesity, the need for safe treatments led to the discovery of incretins. incretin drugs include glucagon-like peptide-1 (glp-1) receptor agonists (ras) and dual-acting therapies that bind glp-1 and glucose-dependent insulinotropic polypeptide (gip) receptors. recent media campaigns focus attention on these repurposed therapies, bringing hope for clinical obesity treatment. these incretin drugs improve glycemic control and lower total body weight up to 20%, incretin drug revolution: the challenges of hope alicia racelis, phd / contract health editor at webmd, fayetteville, ga science series figure 1. timeline for fda regulation of drugs treating clinical obesity.2 bold italicized dates signify the year of removal. fda, us food and drug administration. http://www.amwajournal.org amwajournal.org 36incretin drug revolution: the challenges of hope but questions remain.3 as medical writers, sorting fact from misinformation preserves data integrity and conveys related health risks. although one must acknowledge the role that incretin therapies play in balancing human metabolism, conclusions must be drawn with caution. contrary to news reports, this article points out some critical issues regarding obesity clinical trials and raises concerns about the side effects and long-term safety of incretin drugs. defining disease: clinical trials for obesity the world health organization defines obesity as uncontrolled adipose accumulation that impairs health. about 42% of us adults meet criteria for obesity, and the child and adolescent rate has almost quadrupled since 1990.4,5 despite a century of continued investigation, our understanding of obesity as a chronic disease is not shared across scientific, public health, or political fields. without common symptoms or diagnostic biomarkers, identifying the underlying cause for adipose dysfunction remains difficult. the controversy about obesity influences social stigma, clinical practice, public health policy, and more. evidence demonstrating that individuals with elevated bmi can be metabolically healthy contributes to the confusion.6 defining clinical obesity as a higher visceral mass associated with an existing metabolic dysfunction reflects our current understanding of the adipose organ.7,8 this definition links visceral adipose mass to metabolic health rather than body size, weight-based conditions, or elevated bmi. intra-abdominal distribution of visceral adipose causes chronic low-grade inflammation, hypertrophy, and fibrosis with increased health risks (figure 2).4 in 2023, the american medical association (ama) recognized that using bmi as the only defining characteristic for obesity can racially exclude and harm certain individuals.9 although imaging modalities more precisely calculate adipose distribution, the low cost and ease of application keeps bmi in use. variations in body shape, bone mass, genetics, and waist circumference can alter the risk estimate.8 for example, bmi fails to identify sarcopenic obesity, a loss of muscle mass in the presence of clinical obesity. to resolve this, the ama recommends combining bmi with other indices.9 however, obesity clinical trials and population studies continue to use bmi. in the past 40 years, the obesity pandemic patterns have changed. interestingly, recent urbanization has shifted the obesity prevalence to least-developed countries. the influx of unprocessed, high-calorie foods and other common drivers may contribute to the rising rates.10 in children, developmental factors affecting weight can disrupt the balance of energy intake and expenditure. these broad environmental, preconception, and prenatal exposures are risk factors for obesity with consequences into adulthood.5 in adults, complex interconnected risk factors influence weight:10 • biological • social • food industry influences • physical safety • lived experiences evidence shows a higher risk of developing obesity for youth living in lower social strata or exposed to inequalities.5 similarly, racial and ethnic disparities exist in the prevalence figure 2. health risks related to clinical obesity.4,5 adult is defined as age ≥20 years, and youth is defined as age 2-19 years. gerd, gastroesophageal reflux disease; gi, gastrointestinal; pcos, polycystic ovarian syndrome. http://www.amwajournal.org amwajournal.org 37incretin drug revolution: the challenges of hope for obesity in the united states (figure 3). the increased prevalence of obesity in black and hispanic adults underscores the need for diversity in obesity clinical trials. lack of diversity in clinical trials for obesity clinical trials for obesity should accurately reflect the characteristics of the disease population.13 but a recent meta-analysis revealed that obesity clinical trial participants comprised of 74% white adults, mainly women (table 1).13 in the united states, the cdc reports the highest risk for obesity in black (50%) and hispanic (45%) adults, but only 18% black and 19% hispanic adults participated in the drug trials.13 this lack of diversity during obesity drug testing creates a gap in understanding the risks and benefits of obesity therapies for diverse populations. future studies aim to increase diversity by decentralizing clinical trial centers. but some of the difficulty surrounding diversity in testing is the need for clear guidance in clinical obesity care. guiding clinical care for obesity evidence suggests that lifestyle modification and physical activity remain cornerstones for optimizing health but only provide minimal reductions in weight. using these data, all guidelines suggest pharmacotherapy for adults who are not pregnant and have a bmi ≥27 in the presence of a weight related condition or a bmi of ≥30.14 similarly, the american academy of pediatrics recommends pharmacotherapy for children 8 years and older who meet criteria for obesity.11 the latest clinical guidelines for individuals with obesity tether lifestyle modification to all pharmacotherapy treatment, tailoring therapy to each individual.14 thus, for treatment optimization, clinicians need a wide range of effective and safe medications for obesity.15 because a large body of evidence suggests that weight reductions between 10% and 15% improves cardiometabolic health, guidelines aim for reductions of ≥10%.4 yet before 2021, most clinical trial participants reported obesity drug inefficacy rates ranging from 59% to 80% (figure 5). as an alternative, bariatric surgery became a standard obesity option as part of a flexible care approach. for some patients, bariatric surgery remains a viable long-term solution, improving glucose and lipid levels.4 however, postsurgical complications combined with facility and specialist requirements limit widespread use. the success of individualized obesity care plans depends on identifying individuals for treatment and applying the correct therapy at the right time. health care providers remember the past and remain vigilant when prescribing new obesity drugs. however, media attention drives the demand for incretin drugs, highlighting drug claims of lowered glycemic index, cardiovascular risk, and weight loss of 20% or more.16 although incretin therapies may fill the therapeutic gap between lifestyle modification and surgery, balancing health benefits with risks remains important when choosing drug treatment. approved long-term pharmacotherapies for clinical obesity in the united states, 6 long-term drugs treat clinical obesity, mainly targeting weight loss (table 1). like any treatment, balancing health benefits with risk helps optimize care. yet without robust, independent clinical trials comparing treatments, doctors typically use trial-and-error when prescribing obesity drugs. another common practice is off-label use of low-cost therapies. for example, phentermine and topiramate are 2 of the most used drugs in pediatrics. although phentermine is approved for short-term weight loss in children, topiramate is not. but phentermine with topiramate (phen/top) is approved for long-term weight loss in patients 12 years and older. topiramate, an antiepileptic drug, can affect cognition, sleep, and memory; because of carbonic anhydrase inhibition, the compound also increases risk of taste alteration, metabolic acidosis, and nephrolithiasis. topiramate has teratogenic effects and can cause fetal harm. as an alternative, the fda approved naloxone with bupropion (nal/bu) for use in adults. nal/bu may elevate blood pressure and increase risk of hepatotoxicity or suicidal ideation. comparing long-term therapies for weight loss one review of 28 random controlled trials included orlistat, phen/top, nal/bu, and liraglutide. interestingly, the study showed that clinical trial participants reported the most success using phen/top (75% efficacy) compared with orlistat (44%), nal/bu (55%), or liraglutide (63%).18 more recently, a systematic review and meta-analysis was figure 3. us racial and ethnic differences in the prevalence of adults with bmi ≥30 and youth greater than the ninety-fifth percentile.11,12 adults are defined as age ≥20 years, and youth are defined as age 2-19 years. bmi, body mass index. 9% 25% 26% 17%17% 50% 45% 42% 0% 10% 20% 30% 40% 50% 60% asian black hispanic white youth adults http://www.amwajournal.org amwajournal.org 38incretin drug revolution: the challenges of hope performed using 53 clinical trials for obesity drugs. the findings showed that tirzepatide effectively reduced waist circumference by 6.77 cm compared with semaglutide (3.74 cm) and liraglutide (2.30 cm).19 in a subanalysis, semaglutide was the only incretin drug to effectively reduce low-density lipoprotein and total cholesterol yet showed the highest discontinuation rate because of gastrointestinal (gi) events. in fact, safety concerns for the incretin drugs are warranted at higher doses. except for orlistat, a local-acting lipase inhibitor, all obesity therapies act by increasing norepinephrine to decrease appetite. understanding neuroendocrine signals that regulate hunger helps elucidate related health risks for these drugs. pharmacotherapies: balancing appetite two opposing types of neurons in the hypothalamus balance energy intake to control appetite. the agouti-related peptide/ neuropeptide y (agrp/npy) neurons constantly co-release γ-aminobutyric acid (gaba) and npy peptides to lower sympathetic activity, turning on appetite (figure 4). once food enters the stomach, the gut releases incretins and adipose releases leptin, slowing intestinal motility to prolong satiety.20 the opposing pro-opiomelanocortin/cocaine amphetamine-related transcript (pomc/cart) neurons receive these gut signals to enhance sympathetic release of norepinephrine, turning off appetite. many pharmacotherapies for weight loss increase sympathetic activity and norepinephrine to turn off appetite. gaba-modulating drugs like topiramate increase the brain’s sympathetic activity to lower appetite. but sympathomimetic drugs like phentermine stimulate sympathetic release of norepinephrine to lower appetite.16 bupropion and naltrexone also stimulate sympathetic activity but directly activate pomc/cart neurons to diminish hunger. interestingly, naltrexone acts as a long-acting opioid antagonist to change the brain’s response to food by altering the dopamine-reward system.16 incretin drugs mimic the actions of glp-1 and gip that stimulate glucose-dependent increases in insulin, slow gastric emptying, and extend satiety to lower appetite. although glp-1 ras suppress pancreatic-glucose-dependent release of glucagon, gip receptor agonists stimulate it.15 but the low permeability of incretin drugs likely prevent access through the blood-brain barrier. supporting this, studies indicate that incretin drugs signal the hypothalamus via the dorsal vagal complex, which may explain the negative side effects like nausea and vomiting.15 table 1. fda-approved drugs for clinical obesity treatment11,16,17 drug name brand name usage, y dosage clinical trial demographics orlistat alli (otc); xenical ≥12 capsule: alli, 60 mg; xenical, 120 mg xendos 55% women; mean age, 43 y; average bmi, 37; 71% white adults phentermine with topiramate qsymia ≥12 phentermine/topiramate: 3.75 mg/23 mg; 7.5 mg/46 mg; 11.25 mg/69 mg; 15 mg/92 mg equip 83% women; mean age, 43 y; average bmi,42; 80% white adults conquer 70% women; mean age, 51 y; average bmi, 36; 85% white adults naltrexone with bupropion contrave (us); mysimba (eu) ≥18 naltrexone/bupropion: 8mg/90mg cor-i 85% women; mean age, 44 y; average bmi 36; 82% white adults cor-ii 85% women; mean age, 44 y; average bmi, 36; 83% white adults liraglutide saxenda ≥12 18 mg dial-a-dose pen delivering customizable doses: 30 at 0.6 mg; 15 at 1.2 mg; 10 at 1.8 mg; 7 at 2.4 mg; 6 at 3 mg scale 78% women; mean age, 45 y; average bmi, 38; 85% white adults semaglutide wegovy ≥12 single-use, color-coded pens: teal, 0.25 mg; pink, 0.5 mg; brown, 1mg; blue, 1.7mg; black, 2.4 mg step 1 73% women; mean age, 46 y; average bmi, 38; 75% white adults tirzepatide zepbound ≥18 single-use 0.5 ml pen or vial, comes in doses: 2.5 mg; 5 mg; 7.5 mg; 10 mg; 12.5 mg; 15 mg surmount-1 67.5% women; mean age, 45 y; average bmi, 38; 70% white adults bmi, body mass index; cor-i, contrave obesity research i; cor-ii, contrave obesity research ii; eu, european union; fda, us food and drug administration; otc, over the counter; scale, satiety and clinical adiposity liraglutide evidence; step 1, semaglutide treatment effect in people with obesity; xendos, xenical in the prevention of diabetes in obese subjects. http://www.amwajournal.org amwajournal.org 39incretin drug revolution: the challenges of hope the incretin drug revolution incretin drugs are not new. liraglutide debuted a decade ago, but the drug was not as effective compared with the more recent incretin drugs. the dose required to treat obesity is almost twice that for glucose management in type 2 diabetes. during the satiety and clinical adiposity liraglutide evidence trials, liraglutide reduced total body weight by 6.1%.21 liraglutide did not receive much publicity with high discontinuation rates, gi side effects, and cancer risk. to improve safety and effectiveness, the manufacturer of liraglutide set out to find a compound with a longer half-life. researchers discovered semaglutide, extending the half-life to 168 hours. during the semaglutide treatment effect in people with obesity trials, this compound improved cardiometabolic health and reduced weight by 12.6% (figure 5).21 but similar to figure 4. pharmaceutical action to extend satiety for energy homeostasis.20 α-msh, α-melanocortin stimulating hormone; agrp/npy, agouti-related peptide/neuropeptide y; arc, arcuate nucleus; bat, brown adipose tissue; cck, cholecystokinin; ee, energy expenditure; ffas, free fatty acids; gaba, γ-aminobutyric acid; glp-1 ra, glucagon-like peptide-1 receptor agonist drugs including tirzepatide; mc4r, melanocortin 4 receptor; pomc/cart, pro-opiomelanocortin/cocaine-amphetamine-related transcript; pyy, peptide yy; sns, sympathetic nervous system; wat, white adipose tissue; y1r, npy 1 receptor. 20% 41% 32% 23% 57% 65% 80% 59% 68% 77% 43% 35% ≥≥10% ≥≥10% ≥≥10% ≥≥10% ≥≥10% ≥≥10% orlistat phen/top nal/bu liraglutide semaglutide tirzepatide % effective % ineffective figure 5. percent of individuals experiencing ≥10% weight reduction from drug treatment during clinical trial testing.17,21 nal/bu, naltrexone with bupropion. other incretin therapies, almost 40% of trial participants reported nausea, 70% experienced gi disorders, and almost 10% discontinued the drug.15 the newest incretin drug, tirzepatide, binds glp-1 and gip receptors in the gut.16 this dual-acting drug has been the most http://www.amwajournal.org amwajournal.org 40incretin drug revolution: the challenges of hope successful incretin therapy thus far, with 62% of participants having ≥15% weight reduction, and more than half having ≥20% weight reduction (figure 6). however, about a quarter of participants discontinue treatment because of gi symptoms.22 it has been shown that incretin therapies remain ineffective for about 20% of individuals.23 some patients require dose adjustments, therapy changes, or surgery to reach weight goals. although there are several known benefits for incretin therapies, several challenges remain. challenges of incretin therapy: shifting satiety the incretin drug revolution brings hope for treating obesity and many weight-related conditions. however, sympathetic-extension of satiety may increase long-term risks for chronic disease, including risk for renal disorders and thyroid cancer.16 the brain’s default hunger state may support long-term health, fueling cellular activity through fatty acid metabolism. in contrast, incretin drugs shift the metabolic state to satiety, forcing the brain and other tissues to rely on glucose.24 although the consequences of this shift are unclear, sympathomimetic and incretin drugs increase risk for hypertension, glaucoma, and heart rate (table 2).25,26 incretin drugs may also come with increased risk for anxiety. one study linked chronic activation of agrp/npy neurons with increased anxiety and colitis.27 supporting this, some individuals taking incretin drugs report increased anhedonia and suicidality.15 other challenges of incretin drugs are linked to gastric emptying and include ileus, gastroparesis, and decreased drug absorption.28,29 another complicating issue includes the plateau effect. over time, increased incretin drug dosing may no longer decrease net body mass. this effect has been reported by individuals taking semaglutide and highlights lifestyle modifications as an important part of overall treatment.15 using incretin therapies requires a life-long commitment because health gains disappear with discontinuation. some studies report up to two-thirds of the original weight returns after discontinuation.29 looking ahead in summary, incretin therapies bring a dynamic phase in drug development for treating obesity. these drugs lower glycemic index, reduce cardiovascular risk, and may benefit liver and neurodegenerative conditions. however, the health risks of prolonged satiety states to cardiac, renal, and other tissues remain unclear. incretin drugs have been linked to increased risk for thyroid cancer, suicidality, and elevated heart rate. these medication side effects must be balanced with health benefits and cost, which factor heavily into optimizing individualized clinical obesity treatment plans. given the limited number of high-quality randomized trials comparing obesity drugs, doctors must resort to trial-and-error to predict usefulness. in addition, long-term safety studies in diverse populations are needed to better understand incretin drug effects on growth and development. by 2030, more than 8.5 billion people are estimated to meet criteria for obesity worldwide.10 now more than ever, learning from past mistakes can help improve the quality of clinical obesity care. it is crucial to determine the risks and long-term health benefits of bariatric surgery, drug therapy, and combination treatments to help guide future clinical practice. acknowledgments i thank naomi b. bishop, md, for her review of the manuscript. all figures and tables are compiled, graphed, and designed by the author. the references used in the tables and graphs are cited. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: racelis@msn.com references 1. colman e. anorectics on trial: a half century of federal regulation of prescription appetite suppressants. ann intern med. 2005; 143(5):380-385. 2. wen x, zhang b, wu b, et al. signaling pathways in obesity: mechanisms and therapeutic interventions. signal transduct target ther. 2022;7(1):298. 3. parkman hp, rim ds, anolik jr, dadparvar s, maurer ah. glucagonlike peptide-1 receptor agonists: the good, the bad, and the ugly-benefits for glucose control and weight loss with 16% 11% 23% 62% 57% 84% 89% 77% 38% 43% ≥≥15% ≥≥15% ≥≥15% ≥≥15% ≥≥20% nal/bu liraglutide semaglutide tirzepatide % effective % ineffective table 2. comparison of mean heart rate increases for obesity drugs25,26 drug beats per minute phen/top 0.6-1.6 semaglutide 1-2 liraglutide 3-8 tirzepatide 3-6 nal/bu 0.9-1.2 nal/bu, naltrexone with bupropion; phen/top, phentermine with topiramate. figure 6. percent of individuals experiencing ≥15% or ≥20% weight reduction from drug treatment during clinical trial testing.17,21 nal/bu, naltrexone with bupropion. http://www.amwajournal.org amwajournal.org 41incretin drug revolution: the challenges of hope side effects of delaying gastric emptying. j nucl med technol. 2024;52(1):3-7. 4. elmaleh-sachs a, schwartz jl, bramante ct, nicklas jm, gudzune ka, jay m. obesity management in adults: a review. jama. 2023; 330(20):2000-2015. 5. lister nb, baur la, felix jf, et al. child and adolescent obesity. nat rev dis primers. 2023;9(1):24. 6. bosy-westphal a, müller mj. diagnosis of obesity based on body composition-associated health risks–time for a change in paradigm. obes rev. 2021;22 suppl 2:e13190. 7. volger s, vetter ml, dougherty m, et al. patients’ preferred terms for describing their excess weight: discussing obesity in clinical practice. obesity (silver spring). 2012;20(1):147-150. 8. rubino f, batterham rl, koch m, et al. lancet diabetes & endocrinology commission on the definition and diagnosis of clinical obesity. lancet diabetes endocrinol. 2023;11(4):226-228. 9. tanne jh. obesity: avoid using bmi alone when evaluating patients, say us doctors’ leaders. bmj. 2023;381:1400. 10. swinburn ba, kraak vi, allender s, et al. the global syndemic of obesity, undernutrition, and climate change: the lancet commission report. lancet. 2019;393(10173):791-846. 11. adult obesity facts. centers for disease control and prevention. accessed december 3, 2024. https://www.cdc.gov/obesity/adultobesity-facts/index.html 12. childhood obesity facts. centers for disease control and prevention. accessed december 3, 2024. https://www.cdc.gov/ obesity/childhood-obesity-facts/childhood-obesity-facts.html 13. johnson-mann cn, cupka js, ro a, et al. a systematic review on participant diversity in clinical trials–have we made progress for the management of obesity and its metabolic sequelae in diet, drug, and surgical trials. j racial ethn health disparities. 2023;10(6):3140-3149. 14. gaskin cj, cooper k, stephens ld, peeters a, salmon j, porter j. clinical practice guidelines for the management of overweight and obesity published internationally: a scoping review. obes rev. 2024;25(5):e13700. 15. d’ávila m, hall s, horvath tl. glp-1, gip, and glucagon agonists for obesity treatment: a hunger perspective. endocrinology. 2024;165(11):bqae128. 16. gudzune ka, kushner rf. medications for obesity: a review. jama. 2024;332(7):571-584. 17. chakhtoura m, haber r, ghezzawi m, rhayem c, tcheroyan r, mantzoros cs. pharmacotherapy of obesity: an update on the available medications and drugs under investigation. eclinicalmedicine. 2023;58:101882. 18. khera r, murad mh, chandar ak, et al. association of pharmacological treatments for obesity with weight loss and adverse events: a systematic review and meta-analysis. jama. 2016;315(22):2424-2434. 19. yao h, zhang a, li d, et al. comparative effectiveness of glp-1 receptor agonists on glycaemic control, body weight, and lipid profile for type 2 diabetes: systematic review and network metaanalysis. bmj. 2024;384:e076410. 20. gan h-w, cerbone m, dattani mt. appetiteand weightregulating neuroendocrine circuitry in hypothalamic obesity. endocr rev. 2024;45(3):309-342. 21. henderson k, lewis, sloan ce, bessesen dh, arterburn d. effectiveness and safety of drugs for obesity. bmj. 2024;384:e072686. 22. jastreboff am, aronne lj, ahmad nn, et al. tirzepatide once weekly for the treatment of obesity. n engl j med. 2022;387(3): 205-216. 23. lingvay i, sumithran p, le roux cw, cohen rv. there is no magic bullet for obesity. lancet diabetes endocrinol. 2023;11(8):541. 24. dietrich mo, horvath tl. limitations in anti-obesity drug development: the critical role of hunger-promoting neurons. nat rev drug discov. 2012;11(9):675-691. 25. bramante ct, raatz s, bomberg em, oberle mm, ryder jr. cardiovascular risks and benefits of medications used for weight loss. front endocrinol (lausanne). 2019;10:883 26. lingvay i, mosenzon o, brown k, et al. systolic blood pressure reduction with tirzepatide in patients with type 2 diabetes: insights from surpass clinical program. cardiovasc diabetol. 2023;22(1):66. 27. jiao f, hu x, yin h, et al. inhibition of c-jun in agrp neurons increases stress-induced anxiety and colitis susceptibility. commun biol. 2023;6(1):50. 28. skelley jw, swearengin k, york al, glover lh. the impact of tirzepatide and glucagon-like peptide 1 receptor agonists on oral hormonal contraception. j am pharm assoc (2003). 2024;64(1):204-211.e4. 29. singh s, chandan s, dahiya ds, et al. impact of glp-1 receptor agonists in gastrointestinal endoscopy: an updated review. j clin med. 2024;13(18). http://www.amwajournal.org https://www.cdc.gov/obesity/adult-obesity-facts/index.html https://www.cdc.gov/obesity/adult-obesity-facts/index.html https://www.cdc.gov/obesity/childhood-obesity-facts/childhood-obesity-facts.html https://www.cdc.gov/obesity/childhood-obesity-facts/childhood-obesity-facts.html contents v39 n4 winter 2024 5 7 13 19 23 28 31 35 39 40 44 from the guest editor › tom drake theme articles a beginner’s guide to writing for health economics and outcomes research › annie cheang growth of health economics and outcomes research and real-world evidence in medical communication, and opportunities for medical writers › tom drake, lisa baker, and caitlin rothermel navigating real-world evidence reporting guidelines › laura e. happe and meg franklin topical feature 2024 medical communication compensation report executive summary around the career block leaving the lab for biotechnology writing: a story of zero regrets › cecilia petrus and paul naphtali ce craft corner the narrative edge: the power of storytelling in needs assessments › rhona fraser conscious writing crumbling sentences: isolated and expletive pronouns weaken the foundation of clear medical writing › crystal r. herron creative writing the first dance › brianna c. landis everyday ethics the xyy story as a cautionary tale: how scientific misinformation and common biases can negatively impact lives and opinions › helena i. ebeling and jonathan r. beckwith freelance focus › brian bass, melissa l. bogen, sherri bowen, lori de milto, cathryn d. evans, ,and alex howson q1: how do you handle scope creep on a project? what strategies do you use to define project boundaries and manage client expectations? q2: what are the most effective strategies for negotiating rates with potential clients, especially when there is a significant disparity between your proposed rate and the client’s initial offer? q3: how do you stay competitive in the freelance medical writing and editing market? what strategies do you use to differentiate yourself from other freelancers? 56% 42% 29% 27% 26% 24% 21% 20% 19% 17% 15% 15% 13% 11% 9% 7% 5% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% artificial intelligence (ai) advanced medical writing skills editing/quality control freelancing regulatory writing infographics/visual communications professional development/career advancement plain language/lay audiences regulatory submissions continuing medical education grant writing leadership/management project management publications planning health equity and disparities other (please specify) sales training 72 31 7 editor-in-chief michael g. baker, phd guest editor tom drake, ma, cmpp managing editor rachel mosher, ma section editors progress in publications qing zhou, phd, els regulatory insights jennifer bridgers, ms, mwc science series naomi bishop, md statistically speaking thomas m. schindler, phd everyday ethics julie ravo, ba, ma freelance focus ruwaida vakil, msc ce craft corner haifa kassis, md practical matters elizabeth kukielka, pharmd, ma, ms, mwc around the career block cecilia petrus, msc technology talk kyla ross, bs, ms regular contributors freelance focus brian g. bass, mwc melissa l. bogen, els sherri bowen, ma, els lori de milto, mj cathryn d. evans gail v. flores, phd alex howson, phd phyllis minick in the service of good writing laurie endicott thomas, ma, els conscious writing crystal r. herron, phd, els editors in memoriam lori l. alexander, mtpw, els, mwc ronald j. sanchez 2024–2025 president roshawn (shawn) watson, pharmd, phd, bcps 2024–2025 board liaison qing zhou, phd, els 2024–2025 staff liaison shari rager, ms, cae executive director susan krug, ms, cae graphic designer amy boches, biographics editorial office: managingeditor@amwa.org. instructions for authors available at: www.amwajournal.org. advertising: contact marketing@amwa.org or (240) 239-0940. all advertising is subject to acceptance by amwa and should be for products and services relevant to professional medical communicators. amwa is not responsible for the content of advertising and does not endorse any advertiser or its products or services. subscription: the amwa journal is published quarterly. subscription is included with amwa membership. nonmember subscriptions cost is $75 per year. contact: american medical writers association, 9841 washingtonian blvd, suite 500-26, gaithersburg, md 20878. phone: (240) 238-0940; fax: (301) 2949006; email: amwa@amwa.org. the amwa journal is in the mla international bibliography and selectively indexed in the cumulative index to nursing and allied health literature (cinahl) print index and the cinahl database. the opinions expressed by authors contributing to the journal do not necessarily reflect the opinions of amwa or the institutions with which the authors are affiliated. the association accepts no responsibility for the opinions expressed by contributors to the journal. ©2024 american medical writers association. all rights reserved. issn 2163-5315 amwa journal mission statement in support of the mission of the american medical writers association (amwa) and to advance the broader profession, the amwa journal publishes content that reflects the interests, concerns, and expertise of medical communicators. its purpose is to inform, inspire, and motivate medical communicators. m o re v39 n4 / 2024 48 science series cardiovascular disease in the americas: social determinants, public health policies, and recommendations (part 1) › alan silburn 53 cardiovascular disease in the americas: social determinants, public health policies, and recommendations (part 2) › alan silburn amwa news 57 from the president › shawn watson 58 introducing the 2024–2025 board of directors › shawn watson 59 amwa certificate in regulatory writing core knowledge › lynne munno and aaron van etten 61 the amwa medical writing & communication conference location selection process › shawn watson, kim korwek, julie phelan, jen minarcik, and susan krug 63 dues update in 2025 supports amwa’s enhanced member value › shari rager 65 from novice to expert: establishing a job level framework for medical writers ›janice worley, andriana papaconstantinou, angela burnett, zhiming zhang, kimberly jochman, laura sheppard, julia cooper, julia forjanic klapproth, joan affleck, and jeanette towles 72 results of the 2024 amwa member experience survey › kimberly korwek, jennifer minarcik, and sarah dobney 74 calendar of meetings contents http://www.amwajournal.org american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. v39 n2 / 2024 ©2024 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 11 theme article abstract the capability of artificial intelligence (ai) is rapidly increasing and is now sitting on the threshold of the medical writing field. this article presents an ai integration framework that breaks down adoption of this new technology into manageable steps that ensure an informed and thorough approach. using this framework, individuals and corporations can leverage the benefits of this evolving technology while minimizing risks. the first step, ai literacy, provides a foundation for informed decision making and appropriate expectations for ai capabilities. this knowledge inspires creative exploration of which use cases would be a suitable application of ai tools. once the scope of potential uses is defined, risks can be assessed, including incorrect content generation, data leakage, and bias. ai tools can then be evaluated to find tools that can both satisfy the use cases and mitigate critical threats. the final step is to integrate the tools transparently with appropriate guardrails. then the cycle begins again as ai technology evolves and new applications become possible. as medical writers are ushered further into the ai era, clear and consistent advocacy for a synergy point between the efficiency of ai and the experience, ability, and humanity of a medical writer will maximize the impact of these innovative models. the introduction of publicly available generative artificial intelligence (ai) tools has marked a significant turning point in integrating ai into medical communication. mass-market releases of this new technology started with the launch of chatgpt by openai in november 2022,1 which was quickly followed by other significant large language model (llm) chatbots like claude by anthropic and bard by google. generative ai demonstrated remarkable reasoning capabilities that previously required human medical writing expertise such as turning an unformatted data table into a summary paragraph that includes correct comparisons between groups. an upgrade to gpt-4 in late 20232 was the first of a wave of large multimodal models (lmms) that could process and produce images and audio in addition to text. this period of technological novelty brings with it a wave of ai anxiety among professionals, stemming from fears of job displacement and the reluctance to adapt to changes ai could bring to our daily work. our psychological response to dramatic change mimics the stages of grief; we start with shock, denial, and anger, then progress to depression due to feelings of overwhelm and inadequacy. despite these concerns, it's crucial to recognize the potential of ai to optimize drug development processes, reducing the time and expense of bringing new drugs to patients. exponential growth in the number of ai-enabled drugs and devices may make it necessary for medical writers to adopt generative ai tools to keep up with the workload and do our part to bring treatments to patients faster. this hope for the future can bring us to the upside of the grief response curve, inspiring us to experiment with ai tools, increase our ai literacy, and eventually integrate ai into our work. in the “take the leap! steps to integrate ai into your work” presentation at amwa’s 2023 medical writing and jenni pickett, phd,1 and mandy pennington, bs, mwc2 / 1whitsell innovations, inc, chapel hill, nc; 2freelance medical editor, downingtown, pa take the leap! steps to integrate ai into your work figure 1. ai integration framework. ai, artificial intelligence. ai literacy consider ai use case(s) ai risk assessment ai tool evaluation ai implementation and risk management http://www.amwajournal.org amwajournal.org 12take the leap! steps to integrate ai into your work communication conference in baltimore, maryland, a comprehensive framework for integrating ai was introduced that is relevant for leaders, employees, and freelancers (figure 1). as medical communicators, it is up to us to set the foundation for a future in which the efficiency of generative ai is seamlessly blended with the expertise of medical communicators, harnessing the optimum capabilities of both. ai literacy successful application of llm technology to medical writing hinges on our clear understanding of its benefits and risks. llms are a subset of ai, specifically within the field of generative ai. llms are created through machine learning, specifically deep learning using neural network architecture. machine learning is a way to build a computer program that is distinct from typical programming. it uses different hardware designed to perform many computational steps in parallel. instead of having a programmer define each step for the computer to execute, a data scientist or machine learning engineer sets up a model for the computer to train itself based on provided data sets.3 llms such as gpt-4 from openai are trained on massive amounts of data, allowing them to comprehend inputs and generate human-like responses. gpt stands for generative pretrained transformer, meaning a machine learning model that generates unique outputs, accesses a broad subset of human knowledge from its pretraining, and understands complex user requests using transformer technology. llms can perform tasks like writing, translating languages, coding, creating images, data analysis, and more. an important step in ai literacy for medical communicators is understanding the difference between llms and other ai technologies. many medical writing and editing ai tools are largely expert systems. expert systems resemble the structure and consistency you get with highly detailed templates; they are deterministic and built with extensive human knowledge, which leads to predictable outputs. however, they require structured inputs and are less adaptable to varying tasks. conversely, llms resemble the flexibility and variability you get with simpler, open-ended templates. they are probabilistic, generating outputs based on likelihoods and patterns learned from their vast data sets. this nature makes them more adaptable and flexible but also introduces inconsistency in output and the need for human oversight for accuracy and context. writers may interact with llms in a standalone chatbot (like chatgpt), as a functionality in software (like copilot by microsoft), or in an internet browser (like chrome). llm chatbots, whether standalone or within an application like word, typically have an interface consisting of a blank box, which leaves the determination of what tasks are suitable and reliable entirely up to the user. ai literacy training to understand what tasks are appropriate for llms enables medical writers to leverage these tools effectively, allowing for productivity enhancements while maintaining the high standards of accuracy and context sensitivity crucial in the field. understanding how llms work helps users predict appropriate tasks. there are fundamental differences in how humans and llms write content. human writers research, understand context, and cite specific sources. they bring a unique perspective and a depth of understanding to their writing, albeit with the possibility of errors and gaps, especially when dealing with unfamiliar topics. llms, on the other hand, do not read in the traditional sense. instead, they are trained on text data broken down into tokens (words or parts of words). llms generate text based on patterns learned from their training data, predicting the next token in a sequence. this process can lead to innovative content generation, but it lacks the depth of understanding and context that human writers and editors bring. moreover, llms often cannot trace back to specific sources and might create fake citations or inaccurate content, particularly on topics not well-represented in their training data. retrieval-augmented generation (rag) technology, introduced to mass-market llm tools in late 2023, assists llms by adding a retrieval step before generation. this retrieval step pulls out snippets relevant to the user request from writer-provided or internet-based sources, which are then used and cited in the generation step.4 considering ai use cases armed with a general sense of how llms work, users can think of routine challenges in their work that llms could help with. however, avoid the feeling that an llm can solve everything (ai solutionism) when other tools, such as expert systems or regular software would do a better job. ideal use cases are those that can benefit from an llm's unique capabilities. before evaluating use cases, users should understand that information shared with mass-market llms may be used to train a model owned by another entity. ai etiquette requires requesting permission before using someone’s nonpublic content in any ai system and compliance with ai use policies (employer, client, publisher, etc). because llms can provide inaccurate information, use case outputs should be externally verifiable. llms and lmms can augment users by taking on simple tasks, assist users step-by-step, and amplify users by expanding their skill set (box on next page). http://www.amwajournal.org amwajournal.org 13take the leap! steps to integrate ai into your work “augment” use case examples • formatting lists of abbreviations: fixing capitalization and spelling errors with awareness of proper nouns. • formatting references: aligning to a provided example style. • converting images to text: transform photos of handwriting, slides, or scanned documents to editable text. “assist” use case examples • preparing slide scripts: generating a draft of a presentation script for a slide based on the slide title and key points. • creating images: convert text prompts to pictures for use in presentations or social media. • providing technical support: taking users step-by-step through common computer issues (if the llm recommends entering an admin password or editing registry files, wait for a human to help). “amplify” use case examples • creating a pubmed search string: converting a text request into boolean operators. • writing macros for microsoft office: translating user requests into visual basic for applications and taking the user through the steps to run the program. • performing basic data analysis: parsing large data sets and providing charts to visualize the data (users should be mindful that llms do not clean data automatically). ai risk assessment before using llm-based tools, understanding potential risks and planning how to mitigate them is paramount. establishing a risk profile will help identify tools that fit that profile. risks related to llms can be due to training data limitations, human factors, functional limitations, and/or implementation challenges (figure 2). an llm’s knowledge is rooted in its training data. gaps or weaknesses in training data can result in hallucinations (false information invented by the llm), outdated outputs, or biased responses. examples of training data limitations • data set does not include recent information (ie, after the training data cutoff), unless connected to internet browsing capability. • data set includes outdated practices and language; llm is unaware which practices are now preferred or required. • data set is missing valuable context because it does not include nondigitized content (eg, conference presentations), content behind a paywall (eg, journal articles), or content in an inaccessible format (eg, regulatory guidances in pdf form). llms are very different from any technology previously available, which can introduce risks from human users. examples of human factor limitations • automation bias, the assumption that machine generated content is accurate. • distrust, leading to loss of interest from readers, attrition of employees, or client dissatisfaction. • providing the model with an incorrect or outdated source. • model damage from poisoned training data or manipulative prompts (prompt injection). the machine learning process is the root of some risks related to the way llms function. llms are probabilistic systems that cannot be predicted or entirely understood. examples of functional limitations • opaque decision-making process. • inconsistency of output, even with identical prompts. llm use case “a-list” augment: delegate specific tasks to the llm and review the outcome. assist: collaborate with the llm—the model helps write, edit, and create content. amplify: the llm provides new capabilities, such as coding, creating a data visualization, or teaching a new concept. figure 2. examples of risk categorization for llm tools. http://www.amwajournal.org amwajournal.org 14take the leap! steps to integrate ai into your work • not able to cite sources (unless equipped with rag technology). • can leak your inputs into other users’ outputs (eg, proprietary data, protected health information). implementing ai systems presents challenges that should be considered as part of a risk assessment. examples of implementation challengess • cost (including employee time and opportunity cost). • obsolescence as ai technology quickly advances. • finding legal, nonproprietary training data. risk evaluations should be captured together with planned risk mitigation steps in a risk management plan. the national institute of standards and technology has created an ai risk management framework and playbook as a resource to complete this process.5 ai tool evaluation with a solid understanding of applicable use case(s) and a defined risk profile, it is time to select an appropriate tool to meet both criteria. when evaluating a tool, it is very important to understand which model the tool uses and what, if any, modifications have been made to the model – a tool based on an earlier llm may be a lot less capable than the more recent models. for an expert system with llm features, it is important to understand what features of the tool are based on the llm and what features are based on more deterministic programming so you can determine if the tool matches your risk profile. because machine learning involves various degrees of learning, it can be helpful to think of llm capabilities in layers (figure 3): • the foundation model, like gpt-4 in chatgpt, is similar to the college education of a medical writer, providing a broad base of knowledge. • fine-tuning the model with additional specialty data sets like clinical study reports is similar to the specialized knowledge gained by a medical writer in a graduate or certificate program. • providing the model with access to your data is like on-the-job training. • finally, a collection of proven prompts in a prompt library mimics the efficiency gained with work experience. when delegating a task to a beginning medical writer, you would provide more detail, instructions, and follow up than you would with an experienced medical writer. the same logic applies to llm tools. if the tool has limited layers of capability, your prompt needs a lot of context and specific instruction, and your output may require substantial revision. if your tool has multiple layers of capability, your prompt can be more straightforward and the quality of the llm output will require fewer edits. ai implementation and risk management after choosing your use case(s), evaluating risks, and assessing and choosing an ai tool, the last step in the ai integration cycle is to integrate the tool into your work or organization. ai transparency is critical before, during, and after implementation. it is vital to address reservations that stakeholders may have and set guardrails for ai use. clearly communicate to partners and users what the ai tool is capable of, who will be authorized to use it, when it is appropriate to use ai, why this change is being made, and how to use it appropriately. ai policies to record and share these principles are becoming a common business practice. an ai policy can provide rigid guardrails to protect against the risks identified in your risk management framework. building a prompt library of successful, reliable use cases provides a set of flexible guardrails to further improve quality and reduce risk. the plants acronym is a good starting point for building a prompt: persona, length, audience, nuance, type, and style guide (figure 4). improve the probability of successful implementation by starting with 1 or 2 use cases that an llm can consistently make easier. this feeling of productivity and success can spark more interest in trying other use cases. as you explore new use cases, record not only what works, but what does not work so that those failed prompts can be potentially revised or revisited as llm capability improves. sometimes a failed prompt can become successful when adding one or two examples inside the prompt (also known as one-shot or two-shot prompting). figure 3. potential layers of capability of an llm tool. llm, large language model. http://www.amwajournal.org amwajournal.org 15take the leap! steps to integrate ai into your work a vision for the future medical writers must have involvement in defining the optimal balance between human effort and ai assistance. at one extreme, staying with the status quo of 100% human effort in drug development means continuing to struggle to accelerate time to market and rising development costs, and potentially falling behind competitors. on the other extreme, replacing entire medical writing functions with ai also presents risks. health authorities would reject applications after finding missing submission elements, fake references, and hallucinations. teams would be left with a void of document leadership to break down tasks, set timelines, critically evaluate sources, and gain consensus. now is the time for medical writers to define and advocate for a synergy point that combines the expertise of medical writers with the efficiency of ai. the key is to be strategic, integrating ai where it adds value and ensuring that the core responsibilities of medical writing remain grounded in human expertise. acknowledgments the authors acknowledge cathi harmon for her contributions to the presentation that preceded this manuscript. we also thank sean whitsell, mary ellis bogden, pam fioritto, and ann winter-vann for their review of the manuscript. author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. the authors discuss multiple ai tools but this article is not intended as an endorsement of any product. author contact: jenni.pickett@whitsellinnovations.com references 1. openai. introducing chatgpt. openai. published november 30, 2022. accessed january 21, 2024. https://openai.com/blog/ chatgpt 2. openai. chatgpt can now see, hear, and speak. openai. published september 25, 2023. accessed january 21, 2024. https://openai.com/blog/chatgpt-can-now-see-hear-and-speak 3. ochotny n, byram jk. the use of artificial intelligence and machine learning in clinical research and health care. amwa j. 2023;38(1):30-33. 4. martineau k. what is retrieval-augmented generation? ibm. published august 22, 2023. accessed january 21, 2024. https:// research.ibm.com/blog/retrieval-augmented-generation-rag 5. trustworthy & responsible ai resource center. knowledge base. national institute of standards and technology. published january 26, 2023. accessed january 21, 2024. https://airc.nist.gov/ home figure 4. using the plants method to construct an llm prompt. llm, large language model. http://www.amwajournal.org https://openai.com/blog/chatgpt https://openai.com/blog/chatgpt https://openai.com/blog/chatgpt-can-now-see-hear-and-speak https://research.ibm.com/blog/retrieval-augmented-generation-rag https://research.ibm.com/blog/retrieval-augmented-generation-rag https://airc.nist.gov/home https://airc.nist.gov/home v39 n3 / 2024 ©2024 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 11 theme article abstract ensuring that associate medical writers are set up for success requires a well-planned entry-level program that integrates training sessions with on-the-job experience. we describe how we have crafted our program for entrylevel candidates—starting from our interview process and moving to our training program, how we embed them into teams and provide on-the-job training, how our support network is structured, and how we measure success. feedback from recent participants in our training program offers valuable hands-on insights. a robust foundation of publication training is key to the development of our medical writers, providing skills and helping them develop many of the key attributes that underpin success, including attention to detail, effective storytelling, and industry compliance. our profession is not static, and training programs need to be agile and pivot quickly to accommodate evolving industry standards, new technologies, and fluctuating client and audience needs and challenges. staying up to date with future developments in medical writing is crucial, and we do our utmost to train and support our team and futureproof our training, so our junior writers are well equipped to excel and have fulfilling careers in the life sciences communication industry. introduction medical writers play a pivotal role in ensuring that clinical research findings reach their target audience in a timely manner. as the health care communication landscape evolves, nurturing the new generation of medical writers is paramount. developing an engaging, informative, and relevant training program for aspiring medical writers will prepare them for the varied aspects of their working life and ensure they have the best start to their careers. through comprehensive training, medical writers develop their skills to disseminate scientifically accurate, engaging, and industry-compliant information that will contribute to knowledge of health care advances and ultimately benefit patients. it is essential, therefore, to understand and nurture the multifaceted role of a medical writer. the ability to pivot between diverse types of projects—with strategic acumen, a sharp eye for accuracy, proficiency with digital tools, and a flair for scientific storytelling—is no mean feat, particularly in the rapidly evolving life sciences communication industry. given that the use of generative artificial intelligence (genai) in medical communication is progressing at a rapid pace, the skills of the medical writer must evolve too. expertise in the critical evaluation of genai content will be an essential skill as, in the not-so-distant future, this task becomes a part of a medical writer’s daily life. leaders of entry-level training programs have a responsibility not to shy away from this new technology but to embrace it, train for it, understand how it impacts our clients and audiences, and incorporate it into training plans. a medical writing career can be an inspiring and exciting one. with opportunities for continued learning and knowledge expansion through training and experience, there is rarely a dull moment in this field! to ensure that medical writers are set up for success throughout their careers, training programs should be tailored to all levels of ability and experience. this demonstrates the company’s investment in staff and encourages an environment of shared responsibility for continuous learning and development. for example, in addition to our entry-level program (ignite), the authors’ company also offers an internship program and training tailored to mid-level staff and those moving into leadership positions. these training programs are designed to build confidence in projects of increasing complexity, provide more in-depth training on strategic oversight, and ensure the development of broad leadership skills. to enhance understanding of the purpose and connection with the training, across all levels, we tailor it around our four company values: be brave, be human, be passionate, and be exceptional (box 1). training the medical writers of the future using a structured entrylevel program: a life sciences communications agency perspective michelle utton-mishra, phd, cmpp1; melissa k. purves, phd, cmpp2; linda mascarenhas, ms1; valerie moss, phd, cmpp1 / 1prime, london, united kingdom; 2prime, knutsford, united kingdom http://www.amwajournal.org amwajournal.org 12training the medical writers of the future using a structured entry-level program here, we describe our entry-level program for the benefit of potential future medical writers and those wishing to set up a similar training program, sharing what training works well, offering feedback from our recent trainees, and offering insight into how we are developing the medical writers of the future. our entry-level program at prime, our entrylevel program, which encompasses 12 months of training and on-the-job experience, has been running in its current format for over five years across the united kingdom, europe, and the united states. the program is designed to train junior medical, market access, and patient writers, account executives, and editors to become the life sciences communication stars of the future (figure 1). regardless of department, our trainees attend all sessions and gain broad awareness of the skills needed across the field of life sciences communication through incorporation of elements of writing, editing, and client service projects into the entry-level training sessions. in this way, we equip all junior staff with skills and understanding relevant to many areas of the life sciences communication world, providing a good introduction to collaboration and how to function within a high-performing team. our journey begins with our rigorous recruitment process. for aspiring writers, this process involves writing a mini review per a detailed brief with source materials; a live, timed writing test; and real-life scenario interview discussions. when successful candidates come onboard, they enter our program from their first day. we assign each candidate to a home team with a line manager in that same home team. they integrate into the workings of that team, getting up to speed with the team’s ongoing work, shadowing colleagues, and taking on live tasks with supervision from their second week. we also assign each candidate a buddy (usually someone from a different team who has been through the entry-level program themselves) who can befriend, support, and answer any questions more casually than a line manager and be a friendly face around the office. we start our training by bringing the candidates together in a live classroom setting. they have the opportunity to spend time with each other, which builds camaraderie among peers, and are introduced to many of our team, both for training and informal catch-ups over coffee. we aim to create an environment in which everyone feels nurtured, comfortable to learn, and encouraged to contribute. our training program for medical writers is crafted by our senior scientific team, including our chief scientific officer. the training is delivered by a variety of individuals who have recent hands-on experience, including senior medical writers, and scientific directors. we also organize many sessions given by the wider team, including members of the client services, editorial, finance, digital, evidence and access, and patient engagement teams. this ensures what are your top tips for someone starting a medical writing career? firstly, to read published manuscripts and any other available mat erial; secondly, to ask for feedback and be open to feedback—talk to your colleagues to put things into perspective; and lastly, to be exposed to as many different types of medical writing as possible. interviewer and hope, an associate medical writer. hear hands-on experience from an associate medical writer video 1. https://f.io/e6aenhl9 figure 1. overview of our entry-level training program. f2f, face to face. http://www.amwajournal.org https://f.io/e6aenhl9 amwajournal.org 13training the medical writers of the future using a structured entry-level program our trainees have a fully rounded introduction to various aspects of life sciences communication. our initial round of training sessions set the scene by introducing the job role and pharmaceutical development process, along with soft skills to build confidence. for example, introductory sessions include an introduction to: pharma and an introduction to: drug development, also some role-specific sessions, such as spotlight on: client services. after these initial settling-in sessions, the program expands to cover the many elements of life sciences communication in a blend of live, virtual, and self-led training sessions. topics include: • core publications skills (how to data or fact check, how to approach writing an abstract), • digital production (marking up pdfs, working with the creative team, how to approach developing a poster), and • patient engagement (spotlight on patient engagement and centricity). in addition, we keep the program fresh and introduce contemporary subjects as they arise, such as the impact of genai on our industry and how to verify genai content, presented by in-house subject matter experts. we pair the topics with the most appropriate method of delivery, based on the length of the training and level of interactivity required. straightforward topics are either delivered as virtual or self-led sessions, whereas more involved, interactive training is performed live. having a range of delivery approaches means that, overall, sessions are wellattended, and trainees are engaged. we are conscious that everyone may have different preferences for learning styles, so our curriculum comprises bite-size training materials, slides, videos, task-based learning, and discussion-based sessions. we ask that cameras are turned on for virtual and hybrid sessions, and ensure the format is as interactive as possible, including polls, asking questions throughout, and allowing ample time at the end for discussion. all sessions are recorded and shared, so anyone can return to materials at a later date or catch up on any topics they may have missed. line managers, buddies, and the program organizers work together to ensure everyone’s needs are met and views heard. during the 12-month program, we organize group training days in which we ensure everyone meets face-toface for live training sessions and some fun downtime. the trainees also have the opportunity to hone their presentation skills within a safe space by presenting to each other. the program leads track progress, successes, and challenges through regular meetings with line managers and trainees. a sense of community is encouraged among the trainees throughout. we feel the balance of background training, on-the-job project work, and genuine care that is taken supports company loyalty and encourages staff retention, with many of our trainees progressing to midand then senior-level positions within the company. for an associate medical writer, the on-the-job training starts with a firm grounding in the need for accuracy and attention to detail. they will perform data checks in parallel with more senior colleagues until they feel confident and ready to go it alone. publication writing training is built into the program early on as it gives a good foundation in the other skills needed for medical writing, including experience in interpreting data, ability to develop engaging long-form storytelling, and adhering to the compliance standards of the role. a medical writer supports the author to develop drafts of a publication, facilitating timely publication under author direction.1 understanding publication process is an important part of initial training and allows our associate medical writers to become publication professionals with a strong understanding of our own and client procedures, and a commitment to publication standards of excellence. we also hone scientific storytelling skills throughout all our training, ensuring our writers feel empowered to undertake multiple project types. as our associate medical writers grow in confidence, they begin to engage in other publication projects, taking on client and author interaction responsibilities when they are ready and attending kick-off calls, implementation of good publication practice, and development of deliverables such as graphical abstracts, infographics, video abstracts, and plain language summaries. understanding the strategic relevance behind a publication plan and ensuring an omnichannel approach to reach the right audience, with the right material, at the right time, via the right medium, is discussed early in the entry-level program. the health care landscape in how might the career of a medical writer change in the near future? writers will need to embrace a lot of different needs going forward, especially in an environment where there is strong demand for an omnichannel approach. […] in addition, writers will need to continue to learn more about generative ai and how it can help them deliver more […] as well as identifying where we can innovate using technology platforms […], learning how to deliver not just science—but deliver science strategically. interviewer and moamen, associate scientific team leader and former member of our entry-level program. hear a former trainee discuss his life sciences communication journey video 2. https://f.io/e6aenhl9 http://www.amwajournal.org https://f.io/e6aenhl9 amwajournal.org 14training the medical writers of the future using a structured entry-level program which medical writers work thrives on interdisciplinary collaboration between a broad range of health care professionals, researchers, pharmaceutical colleagues, and patients. by collaborating with patients and professionals from various disciplines, our medical writers gain invaluable experience and learn to adapt their writing style to different audiences. how to measure success for our associate medical writers, we benchmark success against a set of objectives, some universal to the job role and others specifically tailored to each individual. these objectives cover research and writing ability, communication skills, team working, time management, industry compliance, and financial awareness (figure 2). progress toward objectives is reviewed regularly with line managers, and associate medical writers are encouraged to keep a record of their achievements in a centralized human resources system. clearly defined promotion criteria that assess competency in the objectives outlined above are available to line managers and associate medical writers, ensuring that standards are transparent and there are no hidden hurdles. similarly, associate medical writers have access to clear job descriptions for their current and next role, which helps them understand what they need to work toward as they progress through their career. this clear, informationfirst approach means that all associate medical writers have a good understanding of what is expected of them, which helps reduce the instances of performance concerns. occasionally, our associate medical writers experience challenges as they navigate the complexities of life sciences communication, and we have tried-and-tested approaches in place to help them overcome any obstacles. these approaches include access to buddy mentors who have been through the program themselves and can provide guidance on how to navigate what is, for many, their first job after college. secondly, our associate medical writers have access to a peer support network in the form of the other trainees (including other writers, editors, and account executives) who are part of their cohort. learning to work as part of a team is a pivotal part of training. our associate medical writers are encouraged to reach out to their buddies and peer group to discuss challenges and identify solutions; in most cases, challenges can be overcome through these informal discussions. we have observed first-hand how well this approach works, and how effective it is at developing problem-solving skills. thirdly, all associate medical writers have a dedicated, experienced line manager with whom they have weekly touchpoints to discuss progress, as well as ad hoc catch-ups as needed. line managers are trained to provide support and help their line reports to navigate potential challenges. finally, all our trainees have regular meetings with the program heads who check in from an emotional and social support perspective. these catch-ups are usually informal and provide another opportunity to discuss concerns, explore challenges, and access support as needed. our approach has shown success since our entry-level program began in 2017, with 154 candidates entering the program to date. the vast majority of these candidates have completed the entry-level program and are highly trained, resilient, and well rounded, with a passion for life sciences communication and the ability to thrive in a fast-paced and evolving industry. we are proud that they have gone on to fulfilling and rewarding careers, and many are now passing on their skills to develop the medical writers of the future. ways of working, now and in the future we have seen many changes in life sciences communication since the start of our entry-level program, and it is figure 2. setting colleagues up for success. http://www.amwajournal.org amwajournal.org 15training the medical writers of the future using a structured entry-level program important that we continue to evolve to ensure we remain future-proof. for example, one of our cohorts was initiated in 2020, just before the covid-19 pandemic. we had to quickly pivot to a virtual training program while ensuring that our new recruits had the same standard of formal training and on-the-job learning opportunities as those who started before the pandemic. luckily, our team is very resilient; they adapted quickly and embraced these needs, taking every care to give our candidates the best experience possible. the challenges posed by the pandemic underscored the importance of community and added an element of joint accountability, with trainees expected to attend virtual meetings, specific training sessions, and all opportunities for online social events and informal get-togethers. four years on, we (along with many other industries) are now very much in a hybrid world. our trainees are encouraged to come into the office for two to three days per week. we feel this offers the best of both worlds, with trainees exposed to in-person conversations that support their learning in an informal way and help them forge close relationships more quickly than in the fully virtual setting. in the evolving medical writing landscape, embracing modular content creation is a crucial mindset shift for effective omnichannel communication. the omnichannel approach, delivering the right content to the right audience at the right time via the right channel, requires truly understanding the audience, their needs, and their preferred way to receive information. the ability to create content in modules that can be adapted across platforms is key with this approach and needs to be incorporated into processes and training programs to equip medical writers with the skills to maximize the reach and impact of data. in addition, there has been a lot of interest in the use of genai to develop medical content, with the aim of streamlining workflows and quickly tailoring content to different styles and audiences. it is important that our writers understand both the risks and the benefits of emerging technologies, so we provide clear guidance on disclosures, transparency, and the importance of ensuring human oversight and validation within our training program.2 genai may be used in a variety of ways in the future, but medical writers will remain the subject matter experts. over time, they will gain skills in critical thinking, how to interpret data and provide context, and strategic content validation, skills that will be increasingly critical and require appropriate training as we move further into the genai era. conclusion supporting the next generation of highly skilled medical writers is a multifaceted endeavor that requires a comprehensive training approach encompassing strategic, scientific, and clinical knowledge; communication and storytelling skills; technological proficiency; and an understanding of industry compliance. a comprehensive training program will bring together all the necessary instructional elements and on-the-job experience to empower medical writers to shape the future of life sciences communication. we must continuously evolve our educational approach and our materials – from updating information to staying in line with industry standards to improving how we deliver our training sessions. we are always looking for new ways to enhance participants’ engagement, build in interactivity and discussion-based sessions, monitor training achievements, and awareness of how to stay ahead of the latest industry trends. exposing medical writers to the plethora of project types and approaches we can take to support our clients and inform our audiences will encourage them to “be brave”—to challenge established ways of thinking and suggest an alternative solution. this will not only result in forwardreaching communication that meet target audience needs and ultimately result in patients receiving the best care possible but will also ensure we always put our best foot forward to support successful medical writing careers. acknowledgments many thanks to all our ignite cohorts and our colleagues who support in providing and organizing training, line management, and overall support. special thanks to tom gegeny, els, mwc, cmpp, of prime, new york city, ny, for critical review, gaurav kumar, msc, of prime, london, united kingdom, for input, and laura mcardle, ba, of prime, new york city, ny, for editing. author declaration and disclosures: all authors are employees of prime, knutsford, united kingdom. author contact: valerie.moss@primeglobalpeople.com and michelle.utton-mishra@primeglobalpeople.com references 1. detora lm, toroser d, sykes a, et al. good publication practice (gpp) guidelines for company-sponsored biomedical research: 2022 update. ann intern med. 2022;175(9):1298-1304. 2. international society for medical publication professionals (ismpp) position statement and call to action on artificial intelligence. curr med res opin. 2024;40(1):9-10. http://www.amwajournal.org american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. v38 n4 / 2023 ©2023 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 4 theme article ethical principles can be traced as far back as the ancient philosophers, including plato and aristotle, who believed in virtue as a guide for ethical action, and kant, who developed the concept that obligation instructs us how to behave.1 the terms “professional ethics” and “medical ethics” were created by english physician thomas percival in 1803, which led to the adoption of the first code of ethics by the american medical association in 1847.2 today, many corporations and organizations have established a code of ethics for employees and members. these codes provide a guide on what to do, as well as what not to do, in a given situation. adherence to these values strengthens the company culture, minimizes risk, and helps protect the company’s reputation. in addition to potential damage to image and public trust, the financial consequences of unethical behavior can be extensive. one medical device manufacturer and its subsidiaries have paid more than $60 million in settlements due to kickback and fraud allegations.3 even though many organizations have established codes of conduct for their associates, they do not eliminate the potential for misconduct. in 2020, the harvard business review reported the results of a national survey on business practices conducted with more than 14,500 employees across many industries. nearly 1 in 4 survey respondents felt pressured to do things they knew were wrong.4 two articles in this ethics-themed issue present some ethical challenges for medical communicators. the first article by blair hesp and jonathan lee discusses how differences in cultural contexts can alter the interpretation and application of ethical publication practices in the asiapacific region. this topic expands on the articles published in the previous themed issue of the amwa journal on global medical communication. however, addressing cultural differences can be particularly challenging because many of these engagements are conducted virtually. the authors provide recommendations on effective navigation of cultural differences to ensure that contributions are included from all stakeholders and engaging with colleagues in other regions to develop culturally appropriate processes that can strengthen working relationships and expedite project completion. continuing medical education (cme) is an essential component of ongoing professional development for health care providers. however, industry support of cme has raised concerns about the integrity of the content. the second article by eve wilson explores some of the requirements intended to prevent industry bias in continuing education (ce)/cme. medical writers may play a key role in the development of cme materials; practical steps are presented for medical writers to ensure that ce/cme content is fair, balanced, unbiased, and accurate. i wish to thank the authors of these articles for their time and efforts. i also encourage any feedback from amwa members on any personal ethical challenges they’ve encountered in their everyday interactions. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: julie.ravo@bd.com references 1. mintz s. principles of ethical behavior. ethics sage. published november 1, 2016. accessed october 21, 2023. https://www. ethicssage.com/2016/11/everyday-ethics-.html 2. baker r, emanuel l. the efficacy of professional ethics: the ama code of ethics in historical and current perspective. hastings cent rep. 2000;30(4):s13-s17. 3. wallace c. medtronic’s $60m in fraud, kickback settlements: a timeline. becker’s asc review. published july 12, 2023. accessed october 21, 2023. https://www.beckersasc.com/asc-news/ medtronics-60m-in-fraud-kickback-settlements-a-timeline.html 4. ivcevic z, menges ji, miller a. how common is unethical behavior in us organizations? harvard business review. published march 20, 2020. accessed october 21, 2023. https://hbr.org/2020/03/ how-common-is-unethical-behavior-in-u-s-organizations julie ravo / medical writer, franklin lakes, nj preserving ethics in a not so ethical world from the guest editor http://www.amwajournal.org https://www.ethicssage.com/2016/11/everyday-ethics-.html https://www.ethicssage.com/2016/11/everyday-ethics-.html https://www.beckersasc.com/asc-news/medtronics-60m-in-fraud-kickback-settlements-a-timeline.html https://www.beckersasc.com/asc-news/medtronics-60m-in-fraud-kickback-settlements-a-timeline.html https://hbr.org/2020/03/how-common-is-unethical-behavior-in-u-s-organizations https://hbr.org/2020/03/how-common-is-unethical-behavior-in-u-s-organizations american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. v40 n3 / 2025 ©2025 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 3 (re)discovering the necessity of craft in health communication from the guest editor ben riggs / content manager, kettering health, dayton, oh as i write this in may, the tumult of public life has challenged even those who typically reach for the assurance of “this too shall pass.” it will. but what will we find there? that answer, of course, is being worked out—in classrooms, boardrooms, examination rooms, courtrooms, and kitchens. as health communicators, our work to bring clarity to complexity, to connect evidence with empathy, has never felt more essential or exposed. between the still-unfolding dilemmas around the use of generative artificial intelligence (ai), dwindling grant funding, and the shifting presence of trusted authorities in public health, we find ourselves rafting through turbulent waters. talking about craft, i admit, might seem like a luxury. but in truth, it is a lifeline. craft—the intuitive, skilled decisions that lead to clear, effective communication—is what holds when everything else shifts. it helps the public navigate the whitewater of disinformation, fragmented care, and confusion. it steadies them long enough to understand, to choose, to act. it earns back trust. and trust, right now, is endangered. for decades, we operated in a shared public square— imperfect, yes, but functional. experts were trusted. guidelines were followed. institutions held weight. today, that square is fractured and noisy. the voices that people once leaned on are now just one among thousands. and because information moves faster than understanding, the public is left adrift, trying to make confident decisions in a sea of contradiction and noise. this issue of the amwa journal arrives at a moment when craft is more than a professional virtue—it is a moral necessity. clear, thoughtful communication is essential to serving the public interest and supporting the public in making informed health decisions for themselves and their families. whether someone is considering a treatment, enrolling in a clinical trial, or caring for a loved one, the way we craft words and images shapes those choices not just in clinical settings, but across the full spectrum of health literacy. in this issue, you’ll find themed articles looking at ethics and use cases for generative ai in developing images, the role and vulnerabilities of readability tools, and the place of metaphor in health communication, backdropped by the primacy of craft in health communication. this issue, i hope, also offers a reminder that writing is not merely a conveyance of facts. every paragraph we write contains a small social contract between communicator and audience, between subject-matter experts and laypersons, or between a system and someone trying to survive within it. we uphold those contracts with the decisions we make not just as researchers and experts, but as practitioners. as those responsible for choosing the right words in the right order for the right audience, when we uphold that contract with humility, accuracy, and empathy, we help the public move forward even amid the noise, even when trust is scarce. but we cannot extend clarity to others unless we cultivate it ourselves. that begins with our commitment to craft, not just a commitment to accuracy nor to correct grammar. true craft—the slow and principled work of listening, distilling, shaping, and refining, choosing structure with intention, translating complexity without flattening truth. yes, we use tools. yes, we adapt to platforms. but craft is what makes us trustworthy in a landscape that desperately needs people who still care about getting it right. when we’re tempted to shrink back or to wait for stability to return before we write bravely again, let this serve as a reminder: the public doesn’t have that luxury. health decisions don’t pause until the world calms down. and so, our work—sometimes invisible, often unglamorous—becomes all the more vital. keep refining your skill. keep sharpening your ear for plain language. keep advocating for transparency when others are hedging. this is how we meet the moment—not with panic or passivity, but with purpose. in all the noise, people still want to understand. that’s still our job. and it still matters—for this too shall pass. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: ben.riggs@ketteringhealth.org http://www.amwajournal.org american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. contents v39 n2 summer 2024 4 6 8 11 16 20 25 28 31 34 39 43 45 from the guest editor › kyla ross theme articles copilot — essential ai assistant to medical writers › noelle ochotny and mario morel reimagining clinical and regulatory medical writing with generative ai › ravi k. ramachandran, terris j. linenbach, christopher j. ceppi, and anita g. modi take the leap! steps to integrate ai into your work › jenni pickett and mandy pennington topical features the business of medical writing: financial acumen part 3 › joan affleck, dominic de bellis, brian bass, and jeanette m. towles preventing chaos: the critical role of the submission lead › anjana bose, mark bowlby, brenda taylor, and steve sibley original research informed consent writing: facing the patient is in the interest of the sponsor › tatiana zhiganova, olga golubeva, and maxim belotserkovskiy around the career block from public health to patient education › cecilia petrus and kelly henderson leveraging linkedin to successfully launch and grow a freelancing career › cecilia petrus and bhavadharini balaji ce craft corner optimizing continuing education for health professionals: incorporating instructional design principles and frameworks for effective learning › claudia prahst conscious writing 5 pitfalls to avoid when crafting the study question for a research manuscript › crystal r. herron freelance focus 2023 jam session for seasoned freelancers plays to a packed house › brian g. bass in the service of good writing it’s all relative (clauses) › laurie endicott thomas restrictive (defining): the houses that have a black roof are blue. nonrestrictive (modifying): the houses, which have a black roof, are blue. 45 34 16 editor-in-chief michael g. baker, phd guest editor kyla ross, bs, ms managing editor rachel mosher, ma section editors progress in publications qing zhou, phd, els regulatory insights jennifer bridgers, ms, mwc science series naomi bishop, md statistically speaking thomas m. schindler, phd everyday ethics julie ravo, ba, ma freelance focus ruwaida vakil, msc ce craft corner haifa kassis, md practical matters elizabeth kukielka, pharmd, ma, ms, mwc around the career block cecilia petrus, msc technology talk kyla ross, bs, ms regular contributors freelance focus brian g. bass, mwc melissa l. bogen, els sherri bowen, ma, els lori de milto, mj cathryn d. evans gail v. flores, phd alex howson, phd phyllis minick in the service of good writing laurie endicott thomas, ma, els conscious writing crystal r. herron, phd, els editors in memoriam lori l. alexander, mtpw, els, mwc ronald j. sanchez 2023–2024 president r. michelle sauer, phd, els 2023–2024 board liaison qing zhou, phd, els 2023–2024 staff liaison shari rager, ms, cae executive director susan krug, ms, cae graphic designer amy boches, biographics 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not necessarily reflect the opinions of amwa or the institutions with which the authors are affiliated. the association accepts no responsibility for the opinions expressed by contributors to the journal. ©2024 american medical writers association. all rights reserved. issn 2163-5315 amwa journal mission statement in support of the mission of the american medical writers association (amwa) and to advance the broader profession, the amwa journal publishes content that reflects the interests, concerns, and expertise of medical communicators. its purpose is to inform, inspire, and motivate medical communicators. m o re v39 n2 / 2024 practical matters 50 help your clients create more readable patient education materials › genevieve walker regulatory insight 53 say the right thing: developing a program lexicon for cross-functional teams › mia nagarajan and desmond ryan conference session reports 57 developing plain language informed consent forms for multinational clinical trials › anna shurtleff smith 59 plain language with a page limit: strategies for writing 2-page protocol synopses and other deliverables › hanna johnson 61 putting your plain language writing to the test: getting the most out of user testing › anna shurtleff smith conference product showcase 63 yseop's copilot › moira calder 65 draftsmith by perfectit › michael g. baker and katie kelm 66 pleasereview by ideagen › michael g. baker and kelly schrank amwa news 67 from the president › r. michelle sauer 68 2023 annual business meeting for amwa members › kimberly m. korwek 69 the fifth annual amwa executives forum: advances in technology and the future of medical writing › shiri diskin, lisa chamberlain james, aubri charboneau, and daniel wood 74 innovate, inform, and inspire: jazz up medical communication › michele w. sequeira 75 calendar of meetings e1 communicating about and with artificial intelligence applications › j. kelly byram contents http://www.amwajournal.org american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. v40 n3 / 2025 ©2025 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 4 theme article abstract artificial intelligence (ai) is rapidly changing the field of health communication. medical writers, who are central to making complex medical information understandable and usable, now face both new opportunities and new risks. ai can speed up content creation, improve workflow efficiency, and scale production. at the same time, it introduces concerns related to bias, accuracy, and accountability. this paper focuses on 3 core types of bias that affect ai-generated content: data-driven bias, algorithmic bias, and human bias. these biases often arise from unrepresentative training data, flawed system design, or lack of contextual understanding. left unchecked, they can lead to misinformation and worsen health disparities. medical writers play a critical role in mitigating these risks by evaluating ai outputs for accuracy, completeness, and fairness. when guided by clear standards, collaborative practices, and sound editorial judgments, medical writers can help ensure that ai supports ethical, equitable, and effective health communication. this paper offers practical strategies to help medical writers integrate ai tools responsibly without compromising the integrity, ethics, or patient equity of health communication. introduction health communication shapes how people understand medical information, make care decisions, and engage with the health system. it influences patients, clinicians, and the public, affecting everything from treatment to trust. medical writers are central to this work, translating complex science into clear, accurate, and audience-specific content. effective communication requires more than accuracy. language, tone, and context must support understanding and reduce confusion. poor communication can cause harm, whereas strong communication improves outcomes and public health. artificial intelligence (ai) is now frequently part of health content creation. large language models (llms) are used to draft patient materials, clinical summaries, and public messages. these tools are fast and consistent, but they do not understand science. they rely on patterns, not reasoning, and may produce fluent but inaccurate or misleading content. as ai becomes more common, concerns about quality and accountability grow. medical writers are often reviewing or using ai-generated text. they must check for accuracy, assess relevance, and intervene when needed. this requires a clear grasp of both ai’s strengths and limitations. this paper examines common biases in ai-generated health content and offers practical strategies for responsible use. the aim is not to reject ai but to use it in ways that uphold the core values of health communication: clarity, accuracy, equity, and trust. biases in ai use in health communication as ai tools enter health communication, biases become a major concern. these biases can arise from training data, model design, or how systems are used in practice.1-3 if not addressed, they can distort medical information and reinforce health disparities. to use ai responsibly, we must first understand where these biases come from and how they affect communication. for example, training data often lacks representation from diverse populations.3,4 this leads to outputs that ignore or misrepresent certain groups, especially those already underserved. ai may also “hallucinate” facts or apply findings too broadly, further weakening the credibility of the content.5,6 another possible issue is a substantial gap between ai developers and health communication experts.3,7 without adequate collaboration, ai outputs may fail to meet clinical or ethical standards. when human oversight is limited, flawed content can easily go unnoticed.8 table 1 provides detailed information regarding these biases. strategies to mitigate ai biases medical writers play a key role in identifying and correcting ai-related bias. unchecked, these issues can lead to red thaddeus d. miguel, md, mba, msc, rac, rcc; manal el joumaa, msc; rami ali, mscph / thera-business, inc, kanata, canada artificial intelligence bias in health communication: risks and strategies for medical writers http://www.amwajournal.org amwajournal.org 5ai bias in health communication table 1. key biases in ai and their implications for medical writers category core issues examples and/or evidence implications for medical writers data-driven bias biased training data sets nonrepresentative training data sets lack of data set transparency misclassification or omission of demographic subgroups a scoping review of 70 studies found that ai training data sets in dermatology often lacked transparency, used unverified labels, and failed to report patient diversity.1 a review of 74 studies on image-based diagnostic algorithms revealed a systemic geographic bias, with most us models trained on data from just 3 states, namely california, massachusetts, and new york.9 a scoping review of 7,314 articles published using ai techniques found that us and chinese data sets and authors were disproportionately overrepresented, amplifying global health inequities by favoring datarich regions over data-poor ones.2 risk of reinforcing biased or incomplete narratives misrepresentation of underrepresented populations risk of content lacking global applicability risk of amplifying global health inequities algorithmic bias model limitations design flaws and poor generalizability inability to handle context or nuance generation of fabricated or hallucinated content overfitting the model to a training data set leads to poor generalizability to new, unseen cases.4 ai can confidently generate plausible but fabricated data or references.10,11 a study appraising 2 ai-generated minireviews on hereditary angioedema and eosinophilic esophagitis found that although ai used well-articulated language, the content lacked depth, analytical insight, and contained fabricated references. despite being instructed to use scientific references, the ai chatbot relied on freely available resources.12 risk of including false or unverifiable information inconsistencies in tone, structure, or depth compromised credibility of written outputs, especially on topics with limited resources linguistic and cultural gaps englishand westerncentric training exclusion of non-english– speaking populations mistranslation and cultural misrepresentation the dominance of english in benchmarks and training data for llms exacerbates challenges for individuals and organizations in the developing world, predominantly non-english speakers.13 machine translation errors in public-health communication included inconsistent use of terminology, unidiomatic or awkward style, and untranslated text.14 miscommunication due to inaccurate or culturally inappropriate phrasing barriers to multilingual inclusivity limited accessibility for global audiences human bias lack of interdisciplinary collaboration limited engagement with domain experts limited efforts for data exchange unstandardized health data systems without standardized terminologies and data formats, integrating ai tools into clinical workflows becomes challenging.15 a study assessing health care standards in ophthalmology identified multiple gaps, including limited adoption of imaging standards, lack of use cases for integrating ai-based decision support tools, scarcity in common data models to harmonize large data repositories, and the absence of standardized interfaces and outputs for ai algorithms.16 the absence of interdisciplinary collaboration in ai-driven public-health initiatives leads to a lack of standardized classification and summarization of both traditional and ai-based methods. this fragmentation hampers informed decision-making, delays implementation, and deters broader adoption of effective tools.7 incomplete or contextually flawed content lack of alignment with clinical realities or public-health messaging inability to critically assess or interpret outputs incomplete understanding of ai functionality or context undermined reproducibility and generalizability of ai-generated evidence table 1 continued on next page. http://www.amwajournal.org amwajournal.org 6ai bias in health communication human bias (cont.) infrastructure inequity disparities in digital infrastructure and funding resource disparities in data collection underrepresentation of low-income and non-western regions low-resource or underfunded settings are underrepresented in data sets and model development due to disparities in infrastructure, data access, and resource availability.17 racial, gender, and age disparities are affecting clinical decision-making, quality of treatment, and outcome prognosis.18 biased messaging rooted in data-rich regions exclusion of underrepresented communities risk of medical writing failing to address the needs of diverse populations lack of human oversight overreliance on ai tools (automation bias) opaque ai decisionmaking (“black box”) inadequate validation and ethical safeguards frequent false alarms can desensitize users, leading to ignored alerts and perpetuation of ai-generated errors (feedback loops).3 many ai models function as “black boxes,” making their internal logic opaque and limiting humans’ ability to interpret outputs.19 overreliance on ai tools can diminish human critical thinking, leading to uncritical acceptance of ai outputs. this issue is exacerbated by human cognitive fatigue during sustained oversight tasks.8 ai systems often depend on large volumes of sensitive personal or biological data, raising ethical and regulatory concerns. without effective oversight, the balance between data use and individual privacy rights cannot be adequately maintained.8 overdependence on ai-generated text without verification reduced editorial quality and integrity risk of ethical or privacy violations in published content ai, artificial intelligence; llm, large language model. misinformation and reduce the quality of health communication. a practical way forward involves combining human oversight, collaboration, and clear editorial standards. writers do not need to be programmers to make an impact. they can flag biased language, correct errors, and ensure that outputs match clinical evidence. they can also help ensure that information reflects the needs of diverse audiences. working with developers, ethicists, and clinicians strengthens the process. together, these teams can build ai tools that are more accurate, inclusive, and context aware. writers can also help create quality control checklists and review protocols specific to different health communication settings. bias cannot be eliminated entirely, but it can be reduced. through careful review and strong editorial judgment, medical writers can guide ai outputs toward accuracy, fairness, and relevance. human oversight ensuring accuracy and clinical relevance despite their remarkable capabilities, ai systems are not infallible. they lack human qualities such as cognitive reasoning, contextual judgment, and emotional intelligence. these limitations introduce serious risks, especially in high-stakes fields like health communication. in this context, medical writers serve as critical safeguards responsible for validating the consistency, accuracy, and clinical relevance of ai-generated content. this includes checking facts, identifying discrepancies, and correcting biased or misleading content. a common issue when relying on ai-generated data is the overgeneralization of specific findings beyond the populations studied, especially in summarized medical information.20 when ai systems generate diagnostic content or treatment suggestions, they may generalize findings toward an irrelevant population, without considering individual patient needs.21 for example, in a study of chest radiograph classifiers trained on 3 large chest x-ray data sets and 1 multisource data set, ai systems were found to selectively underdiagnose conditions in underserved patient populations.22 the underdiagnosis rates were even higher for intersectional subgroups, such as hispanic female patients. these frequent misclassifications increase the risk of delayed or missed treatment. this illustrates how algorithmic generalization can perpetuate or amplify disparities when ai systems are deployed without accounting for specific variations or patient context. medical writers should remain alert to this dynamic as overgeneralizations produced by ai can distort scientific understanding and undermine the standards of precision and equity required in health communication. another issue is hallucinations, in which even the most advanced and well-trained ai tools can generate fabricated http://www.amwajournal.org amwajournal.org 7ai bias in health communication data or references. hallucination in scientific citation was shown to affect approximately 20% to 50% of ai-generated content, depending on task complexity.6,23 in response to these challenges, medical writers must always scrutinize the sources cited and referenced by ai tools. their oversight helps uncover potential inaccuracies or hallucinations, which may otherwise go unnoticed.5 this can be facilitated by the use of citation verification tools that automatically flag fabricated or incorrect references generated by ai.24 another effective strategy is applying retrieval-augmented generation, which can constrain ai outputs to trusted, realtime databases, thereby mitigating ai hallucinations.25,26 evidence suggests that ai cannot be solely relied upon to produce complex health communication materials without human oversight. a recent study by mcminn et al highlights the ongoing need for editorial review when using llms to generate plain language summary abstracts.27 the study found that llms can introduce persistent errors, such as misrepresenting clinical content, reinforcing inaccurate associations between conditions and demographics, and omitting or misusing sensitive terms. although ai-assisted approaches improved readability and reduced drafting time, the authors stressed that medical writers remain essential for reviewing and refining content to ensure accuracy, clarity, and appropriateness for lay audiences. reviewing fairness, equality, and equity medical writers must remain vigilant to detect embedded biases in ai outputs, such as skewed disease associations, exclusion of certain populations, and the use of inequitable language. although these issues are best addressed at the levels of data collection and algorithm design, human oversight at the postprocessing stage remains critical. by carefully inspecting and revising the generated ai content, medical writers can correct language that may exacerbate existing inequalities, discriminate against marginalized groups, or perpetuate gender stereotypes. additionally, they can mitigate bias through implementing content filters and transfer learning methods to adapt models to diverse populations. they can also be part of regular audits, continuous monitoring, and feedback loops that are performed to enhance fairness, equality, and equity over time.28 a key element in promoting fairness, equality, and equity in health communication is the use of appropriate terminology and word choice. ai content does not consistently use appropriate or inclusive terminology, which highlights the need for supervision by medical writers. for example, medical writers can rely on established terminology standards such as the international statistical classification of diseases, systematized nomenclature of medicine— clinical terms, and logical observation identifiers names and codes.15 the american medical association and the association of american medical colleges have further emphasized the medical writer’s role in their guide, advancing health equity: a guide to language, narrative and concepts, which offers comprehensive support for equity-focused, person-first language.29 understanding the characteristics of the targeted audience is essential to effective health communication. however, ai may not be able to implement audience-specific writing in the same way humans do. medical writers must think about who will read their content and how word choice will influence interpretation. accordingly, they must tailor their writing tone, structure, and technical depth to suit the target audience. the impact of word choice goes beyond clarity; it shapes perception and can either foster inclusivity or perpetuate exclusion. by being aware of audience needs, both medical writers’ expertise and ai can combine to produce content that is accurate, culturally sensitive, and tailored to diverse audiences. training and education several studies suggest that training and educating relevant stakeholders can help mitigate ai bias, which can be applied to users such as medical writers. hasanzadeh et al highlighted the need for training and educating users on how to critically evaluate ai-generated recommendations.30 they suggested that routine engagement in critical thinking exercises helps teams recognize and overcome ai pitfalls and biases. in addition to improving awareness, these exercises help maintain mindfulness of sensitive attributes such as age, gender, or ethnicity that may be unintentionally amplified in ai outputs. other studies support this approach, showing that training improves how health care professionals use and assess ai tools.30-32 one important area for training is explainability, which refers to understanding how ai systems produce their outputs. many ai models operate as “black boxes,” offering little insight into how decisions are made. in health care, in which such outputs can influence care, medical writers must be able to assess whether ai-generated content aligns with clinical standards. this ability to interpret and question ai outputs helps writers ensure ethical, accurate, and safe communication.31 collaboration with different stakeholders addressing bias in ai requires a coordinated effort across health communication stakeholders, including clinicians, developers, policymakers, and medical writers.3,17 as digital health tools evolve, medical writers must move beyond content creation and take on more active, collaborative roles. from the early stages of ai development, writers can help apply clinical terminology appropriately and develop http://www.amwajournal.org amwajournal.org 8ai bias in health communication quality control tools, such as standardized review checklists. one example is the model, evaluation, timing, range/ randomization, individual factors, count, and specificity of prompts and language checklist, designed to improve consistency in generative ai health care studies by addressing model design, evaluation, timing, and other key factors.33 these tools can be adapted for use in patient education content, clinical summaries, and public-health messaging. interdisciplinary collaboration also helps align ai outputs with current evidence and ethical standards. by working with ethicists, clinicians, and technologists, writers can define limits for appropriate ai use and support policy development for transparent disclosure of ai involvement.34 writers also play a key role in promoting patient-centered communication in ai outputs. ai tools may lack empathy, but writers can help ensure outputs reflect patient needs and values by collaborating with care teams.35 this improves engagement, supports individualized care, and strengthens trust. finally, medical writers can share best practices through conferences and forums. these platforms offer opportunities to refine how ai is used in health communication, promote responsible use, and lead training on reviewing and editing ai-generated content. transparency in ai usage transparency is essential to the ethical use of ai in medical writing. writers must take full responsibility for disclosing when ai tools are used, in line with guidelines from the international committee of medical journal editors, which state that ai systems do not meet the criteria for authorship.36 authors must also ensure that ai-generated content is accurate, free from plagiarism, and properly sourced. because language models may overlook or exclude alternative viewpoints, writers must actively check for balance and ensure content reflects a full range of perspectives.37 clear disclosure builds trust. when clinicians, policymakers, and the public understand how ai was used to produce medical content, they are more likely to accept it. this includes not only acknowledging ai use but also providing details about model decisions and data sources. proper citation also gives credit to the creators of the model and its training data.38 public trust is essential for ai adoption in health care. studies show that lack of transparency leads to skepticism, even when the technology offers real benefits.39 medical writers can address this by reviewing ai outputs carefully and ensuring that content remains clear, accurate, and accountable. rather than resisting new tools, writers can use ai responsibly to strengthen communication and build public confidence in its use. conclusion as ai continues to shape health communication, the role of medical writers must adapt. ai tools can support efficiency and help generate various forms of content, but they cannot replace human expertise. the risks of misinformation, hallucination, and bias remain significant. writers must apply critical thinking and understand the origins of these risks to ensure content remains accurate and responsible. ai should be used as a tool, not a source. it can assist with early drafting or summarization, but final content must be guided by human input. this approach reflects writing by design, in which writers take intentional control over how content is created, verified, and communicated. keeping a human in the loop is essential. medical writers must stay involved throughout the process to evaluate quality, correct errors, and ensure the message is clear and equitable. those who learn to work with ai, rather than against it, will help lead the field forward. by using ai responsibly and thoughtfully, writers can maintain high standards and strengthen public trust in digital health communication. author declaration and disclosures: the authors note no commercial associations that may pose a conflict of interest in relation to this article. author contact: rmiguel@therabusiness.com references 1. daneshjou r, smith mp, sun md, rotemberg v, zou j. lack of transparency and potential bias in artificial intelligence 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g, adedinsewo d, azizi z, white ja. bias recognition and mitigation strategies in artificial intelligence healthcare applications. npj digit med. 2025;8(1):154. doi:10.1038/s41746-025-01503-7 31. sadeghi z, alizadehsani r, cifci ma, et al. a review of explainable artificial intelligence in healthcare. comput electr eng. 2024;118:109370. doi:10.1016/j.compeleceng.2024.109370 32. misra r, keane pa, hogg hdj. how should we train clinicians for artificial intelligence in healthcare? future healthc j. 2024;11(3):100162. doi:10.1016/j.fhj.2024.100162 33. sallam m, barakat m, sallam m. a preliminary checklist (metrics) to standardize the design and reporting of studies on generative artificial intelligence-based models in health care education and practice: development study involving a literature review. interact j med res. 2024;13:e54704. doi:10.2196/54704 34. harishbhai tilala m, kumar chenchala p, choppadandi a, et al. ethical considerations in the use of artificial intelligence and machine learning in health care: a comprehensive review. cureus. 2024;16(6):e62443. doi:10.7759/cureus.62443 35. yelne s, chaudhary m, dod k, sayyad a, sharma r. harnessing the power of ai: a comprehensive review of its impact and challenges in nursing science and healthcare. cureus. 2023;15(11):e49252. doi:10.7759/cureus.49252 36. defining the role of authors and contributors. international committee of medical journal editors. accessed may 8, 2025. https://www.icmje.org/recommendations/browse/roles-andresponsibilities/defining-the-role-of-authors-and-contributors. html 37. fingerhut a, winter dc. artificial intelligence and medical writing: where are we going? br j surg. 2023;110(8):883-884. doi:10.1093/bjs/znad169 38. doyal as, sender d, nanda m, serrano ra. chatgpt and artificial intelligence in medical writing: concerns and ethical considerations. cureus. 2023;15(8):e43292. 39. cheong bc. transparency and accountability in ai systems: safeguarding wellbeing in the age of algorithmic decisionmaking. front hum dyn. 2024;6:1421273. doi:10.3389/ fhumd.2024.1421273 http://www.amwajournal.org https://www.ama-assn.org/system/files/ama-aamc-equity-guide.pdf https://www.ama-assn.org/system/files/ama-aamc-equity-guide.pdf https://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html https://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html https://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. https://trilogywriting.com/trilotalk/ https://trilogywriting.com/trilotalk/ american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. contents v40 n2 summer 2025 3 4 7 10 13 18 24 27 30 32 36 from the guest editor › cathy tyrrell theme articles the evolving role of medical writers: ai as a partner in regulatory submissions › lisa chamberlain james and julia cooper leadership development for medical writers: key insights from the 2023-present amwa educational workshop › angela russell winnie and julia forjanic klapproth the value of medical writing: a toolkit for defining, achieving, and communicating success › cathy tyrrell topical features medical writing career pathways in the asia-pacific region: evolution, diversity, and growth › blair hesp, bert yu-hung chen, henry chung, shobana ganesan, jonathan lee, nicola ryan, pearl toh, yaming wang, tim stentiford conference award 2024 walter c. alvarez award address – otis w. brawley, md, macp, frcp(l) around the career block breaking into regulatory writing: tried and tested tips › cecilia petrus and amber carr my freelance medical writing journey and what i learned along the way › helen fosam ce craft corner book review: writecme roadmap: how to thrive in continuing medical education with no experience, no network, and no clue › kerry kennedy enhancing health outcomes by bringing the patient voice into cme › alejandra viviescas conscious writing the key elements of an introduction section of a research manuscript › crystal r. herron 32 18 13 editor-in-chief michael g. baker, phd managing editor rachel mosher, ma section editors around the career block cecilia petrus, msc ce craft corner haifa kassis, md everyday ethics julie ravo, ba, ma freelance focus ruwaida vakil, msc global medical communication thomas m. schindler, phd practical matters elizabeth kukielka, pharmd, ma, ms, mwc progress in publications qing zhou, phd, els regulatory insights kimberly jochman, phd, rac science series naomi bishop, md technology talk kyla ross, bs, ms regular columns conscious writing crystal r. herron, phd, els(d) in the service of good writing laurie endicott thomas, ma, els regular contributors freelance focus brian g. bass, mwc melissa l. bogen, els sherri bowen, ma, els lori de milto, mj cathryn d. evans gail v. flores, phd alex howson, phd phyllis minick editors in memoriam lori l. alexander, mtpw, els, mwc ronald j. sanchez 2024–2025 president roshawn (shawn) watson, pharmd, phd, bcps 2024–2025 board liaison jennifer minarcik, ms 2024–2025 staff liaison shari rager, ms, cae executive director susan krug, ms, cae graphic designer amy boches, biographics editorial office: managingeditor@amwa.org. instructions for authors available at: www.amwajournal.org. advertising: contact marketing@amwa.org or (240) 239-0940. all advertising is subject to acceptance by amwa and should be for products and services relevant to professional medical communicators. amwa is not responsible for the content of advertising and does not endorse any advertiser or its products or services. subscription: the amwa journal is published quarterly. subscription is included with amwa membership. nonmember subscriptions cost is $75 per year. contact: american medical writers association, 9841 washingtonian blvd, suite 500-26, gaithersburg, md 20878. phone: (240) 238-0940; fax: (301) 2949006; email: amwa@amwa.org. the amwa journal is in the mla international bibliography and selectively indexed in the cumulative index to nursing and allied health literature (cinahl) print index and the cinahl database. the opinions expressed by authors contributing to the journal do not necessarily reflect the opinions of amwa or the institutions with which the authors are affiliated. the association accepts no responsibility for the opinions expressed by contributors to the journal. ©2025 american medical writers association. all rights reserved. issn 2163-5315 amwa journal mission statement in support of the mission of the american medical writers association (amwa) and to advance the broader profession, the amwa journal publishes content that reflects the interests, concerns, and expertise of medical communicators. its purpose is to inform, inspire, and motivate medical communicators. m o re v40 n2 / 2025 39 freelance focus › cathryn d. evans, gail flores, and alex howson q1: how do you balance the need for continuous learning and skill development with the demands of client work? what resources or strategies do you use to stay updated on industry trends and advancements? q2: how do you manage multiple projects with overlapping deadlines? what project management tools or techniques do you find most effective? q3: how do you determine your hourly rate or project fee? what factors do you consider when setting your pricing? 41 practical matters managing time: productivity meets happiness › madhobi sen and bhawna basin 44 progress in publications current guidelines on the use of generative artificial intelligence in peer-reviewed scholarly publications › hannah h. chang, anil sindhurakar, and qing zhou amwa news 49 from the president › shawn watson 50 2024 annual business meeting for amwa members › jennifer minarcik 51 amwa annual financial report, 2023–2024 › julie phelan 53 rise, reflect, and reimagine medical communication › mary ellen shepard 54 calendar of meetings contents http://www.amwajournal.org how it feels when you’ve calmed the document review chaos eliminate the comment, version and compliance chaos with our software for medical writing document reviews. start accelerating timelines and get therapies to market faster with ideagen pleasereview today. key integrations: trusted by: 85% of the top 25 global pharma 4 out of the top 5 cros 4 out of the top 5 medical device companies get free trial go.ideagen.com/ pleasereview-free-trial-life-science discover our g2 awards go.ideagen.com/pleasereview-free-trial-life-science american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. do it smarter do it faster smile more do it with do it smarter do it faster ��������������� ���������� https://trilogywriting.com/ai american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. contents v40 n4 winter 2025 topical feature happy 85th anniversary amwa › jennifer minarcik and shari rager original research a comparative analysis of author guidelines on the use of generative artificial intelligence for manuscript preparation in the top 100 medical journals › christos evangelou and james lee marchant freelance focus › brian bass, melissa l. bogen, sherri bowen, cathryn d. evans, and alexandra howson q1: what are the challenges and opportunities of working with virtual teams and remote clients? how do you build effective working relationships in a remote environment? q2: how do you estimate project timelines and budgets accurately? what tools or methods do you use to improve your project management skills? q3: how do you see the role of medical writers changing in the era of generative artificial intelligence (gen ai)? what new opportunities and challenges do you anticipate? in the service of good writing make full use of your dictionary and thesaurus › laurie endicott thomas science series an oncology immunotherapy primer for medical writers: understanding hype versus hope › rachel feaster writing to improve exercise habits: why it’s a heavy lift › peter stein 44 iraes nervous system -neuropathy dermatologic -rash -pruritis ocular -vision changes pulmonary -pneumonitis renal -elevated scr -aki cardiovascular -myocarditis -pericarditis endocrine -t1dm -hypo/hyperthyroidism -hypophysitis gastrointestinal -colitis hepatobiliary -transaminitis -pancreatitis musculoskeletal -arthritis -myositis 26 8 3 8 17 20 26 35 editor-in-chief michael g. baker, phd managing editor rachel mosher, ma guest editor ben riggs section editors around the career block cecilia petrus, msc ce craft corner haifa kassis, md everyday ethics julie ravo, ba, ma freelance focus ruwaida vakil, msc global medical communication thomas m. schindler, phd practical matters elizabeth kukielka, pharmd, ma, ms, mwc progress in publications qing zhou, phd, els regulatory insights kimberly jochman, phd, rac science series naomi bishop, md technology talk kyla ross, bs, ms regular columns conscious writing crystal r. herron, phd, els in the service of good writing laurie endicott thomas, ma, els regular contributors freelance focus brian g. bass, mwc melissa l. bogen, els sherri bowen, ma, els lori de milto, mj cathryn d. evans alex howson, phd phyllis minick editors in memoriam lori l. alexander, mtpw, els, mwc ronald j. sanchez 2025–2026 president kimberly korwek, phd 2025–2026 board liaison jennifer minarcik, ms 2025–2026 staff liaison shari rager, ms, cae executive director/ceo susan krug, ms, cae graphic designer amy boches, biographics editorial office: managingeditor@amwa.org. instructions for authors available at: www.amwajournal.org. advertising: contact marketing@amwa.org or (240) 239-0940. all advertising is subject to acceptance by amwa and should be for products and services relevant to professional medical communicators. amwa is not responsible for the content of advertising and does not endorse any advertiser or its products or services. subscription: the amwa journal is published quarterly. subscription is included with amwa membership. nonmember subscriptions cost is $75 per year. contact: american medical writers association, 9841 washingtonian blvd, suite 500-26, gaithersburg, md 20878. phone: (240) 238-0940; fax: (301) 2949006; email: amwa@amwa.org. the amwa journal is in the mla international bibliography and selectively indexed in the cumulative index to nursing and allied health literature (cinahl) print index and the cinahl database. the opinions expressed by authors contributing to the journal do not necessarily reflect the opinions of amwa or the institutions with which the authors are affiliated. the association accepts no responsibility for the opinions expressed by contributors to the journal. ©2025 american medical writers association. all rights reserved. issn 2163-5315 amwa journal mission statement in support of the mission of the american medical writers association (amwa) and to advance the broader profession, the amwa journal publishes content that reflects the interests, concerns, and expertise of medical communicators. its purpose is to inform, inspire, and motivate medical communicators. m o re v40 n4/2025 amwa news 41 from the president › kimberly korwek 43 introducing the 2025-2026 board of directors › kimberly korwek 44 2025 harold swanberg distinguished service award recipient: robin whitsell, ba, bph › loretta bohn 45 taking the medical writing certified examination just got easier—again! › brian g. bass 46 calendar of meetings contents http://www.amwajournal.org v39 n3 / 2024 ©2024 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 9 theme article the questions i’m asked about medical writing are often “how do i become a medical writer?” or “what is the best background?” or “what kind of training is crucial to success?” i’d like to humbly suggest that these are the wrong questions. i think a better question might be, “how do i know i’ll be happy as a medical writer?” the why i began my career as a medical writer after almost 10 years in clinical development where medical writing responsibilities overlapped with my other job expectations. conversely, one talented medical writer i know found this career following a prestigious postdoctoral fellowship. and still another gifted medical writer’s first industry role was as a study coordinator at a clinical research site (and she had previously worked at two different nuclear power plants). there is very little overlap between our academic or career backgrounds. the one attribute we share is that we were attracted to medical writing by the very real opportunity to have an impact in the lives of patients. in my experience, medical writers are often driven by a strong why, a sense of purpose that creates an ethical foundation for our work. when we think about the (nonfiction) stories we are telling, we know that, ultimately, our words impact other humans. reflecting on our own individual why allows us to have a deeper well of patience and empathy for the challenges of our role. for me, the rwo greatest gifts of being a medical writer are the relationships i have found within the industry (including the medical writing community) and the knowledge that my work has helped patients, especially those i call family and friends. once you have clarity around your why, there are additional characteristics worthy of reflection. ability to solve problems if you don’t enjoy complexity, medical writing may frustrate you. for medical writers, there is always something to learn and a problem to solve. medical writers routinely face new ideas, new therapeutic areas, new technologies/systems, and new team dynamics. each of these challenges becomes a puzzle to unpack, unwind, and understand. a level head and tenacity are needed because it is common for a solution that worked in one situation to be less useful in a different situation, or a tactic that worked for one team to be less useful for a different team or even a different encounter with the same team. hence, a critical trait for medical writing is a solutionist mindset—the new problem is a puzzle, not a roadblock, and solving each problem is intrinsically rewarding. curiosity between the ever-evolving science and the health authorities’ efforts to drive innovation, intellectual laziness doesn’t work for medical writers. in a 2023 survey of 800 c-suite executives conducted by a for-profit education platform (edx),1,2 49% of the responding leaders questioned how relevant their workforces’ current skills would be with the rise of artificial intelligence. although an education platform would have a good reason to identify and report these results, the findings feel reasonable to me. even very experienced medical writers face learning curves. with some of my company’s recent clients, the science driving their innovations would have been relegated to science fiction when i was in college. we have to interrogate ideas with curiosity and openness. job satisfaction as a medical writer means enjoying and thriving as a life-long learner. willingness to lead without organizational authority though, arguably, everything would be better if teams did things exactly as advised by their medical writers, it is exceptionally rare (maybe nonexistent) for the medical writer to carry organizational authority over a team. not surprisingly, according to randstad’s 2024 workmonitor report,3 management and leadership skills were the highest training priority among workers in the united states. this is well-aligned with medical writing. our role requires time and timeline management, written and oral communication skills, and the ability to direct a team of document contributors. most successful medical writers carry a deep sense of responsibility for their documents, their teams, and the patients they want robin whitsell, ba, bph / founder and president, whitsell innovations, inc, chapel hill, nc the call of the open road: is medical writing right for you? http://www.amwajournal.org amwajournal.org 10the call of the open road: is medical writing right for you? to help. embracing document ownership, coupled with the skills of nonprosecutory levels of stalking, allows medical writers to extract the relevant contributions from team members, navigate team dynamics, and deliver high-quality documents. the balancing act of this leadership relies on tact, steadfastness, and leaning on communication and rapport soft skills. comfort with discomfort in a 2023 linkedin survey4 looking at desirable worker skills, the skill with the sharpest rise in demand over the study period was adaptability. although the survey authors did not release a list of the specific roles they assessed, satisfaction as a medical writer is closely tied to this skill. like many industries, medical writers are impacted by technology, including the exploration of artificial intelligence—even as our value proposition might be questioned. what may be nonobvious is, despite how we feel about these changes, medical writers have to be ahead of each new advancement. we continually stare down learning curves to lead and support our teams as they navigate emerging technologies from regulatory information management systems to specific document requirements and workflows. commonly, the medical writer is mapping out the best way to interact with the newest system deployed by our employers, even if that experience is frustrating for us. medical writers might be the change agents of their teams. medical writers also have to exercise mental and emotional agility. they have to find ways to work with challenging circumstances and personalities. it’s common for team members to feel a need to be seen as right and smart. rather than being right, we have to embrace getting the document right. this can feel uncomfortable, especially when a document we have worked on is being critiqued less on its merit and more on how it aligns to the story a team member wants to tell or the way that the team member(s) want to tell it. sometimes medical writers have to lead complex and difficult conversations and provide feedback to support delivering documents that will pass health authority muster. in a room full of very smart people, a medical writer has to remain unflappable and composed in order to build consensus without ruffling egos or compromising data integrity. your open road in the you’re wrong about podcast,5 sled dog musher and author blair braverman corrected a misconception about the lead dog of a sled dog team and detailed how it parallels with leadership in the human world. she described how, contrary to the societal idea of the alpha dog, the dog leading a team was not necessarily stronger, more vicious, or more dominant. dogs, as pack animals, are more comfortable chasing another dog. finding a dog who sees an open trail and experiences excitement is rare. they could be shy, and they could be quiet… they're good at finding the trail, breaking the trail in deep snow, navigating, setting a pace, listening to cues from the musher, pushing through storms, (and they) like using their own instincts. and it's energizing for them in a way that other dogs on the team might find it exhausting to be making those decisions.5 her explanation felt very much like being a medical writer. if you are passionate about your potential to help people, enjoy solving problems, embrace curiosity and the opportunity to continuously learn, are undeterred by leading without organizational authority, and facing challenges energizes rather than exhausts you, congratulations! you have found a career that can deliver these adventures. medical writing is for you. acknowledgments the author thanks karen campbell, ms, for her review and critique, and wi employees for brainstorming one word (only) that describe a medical writer. author declaration and disclosures: the author notes no commercial associations that may pose a conflict of interest in relation to this article. author contact: robin.whitsell@whitsellinnovations.com references 1. mckendrick j. half of all skills will be outdated within two years, study suggests. forbes. updated october 16, 2023. accessed may 31, 2024. https://www.forbes.com/sites/ joemckendrick/2023/10/14/half-of-all-skills-will-be-outdatedwithin-two-years-study-suggests/ 2. edx survey finds nearly half (49%) of ceos believe most or all of their role should be automated or replaced by ai. edx. published september 19, 2023. accessed may 31, 2024. https://press.edx. org/edx-survey-finds-nearly-half-49-of-ceos-believe-most-or-allof-their-role-should-be-automated-or-replaced-by-ai 3. hess aj. the 5 skills workers value the most in 2024, according to new research. fast company. published january 17, 2024. accessed may 31, 2024. https://www.fastcompany. com/91011036/the-5-skills-workers-value-the-most-in-2024according-to-new-research 4. brodnitz d. the most in-demand skills for 2024. linkedin. published february 8, 2024. accessed may 31, 2024. https://www. linkedin.com/business/talent/blog/talent-strategy/linkedinmost-in-demand-hard-and-soft-skills 5. marshall s. balto with blair braverman. you’re wrong about. march 4, 2024. accessed may 31, 2024. https://yourewrongabout. buzzsprout.com/1112270/14627592 http://www.amwajournal.org https://www.forbes.com/sites/joemckendrick/2023/10/14/half-of-all-skills-will-be-outdated-within-two-years-study-suggests/ https://www.forbes.com/sites/joemckendrick/2023/10/14/half-of-all-skills-will-be-outdated-within-two-years-study-suggests/ https://www.forbes.com/sites/joemckendrick/2023/10/14/half-of-all-skills-will-be-outdated-within-two-years-study-suggests/ https://press.edx.org/edx-survey-finds-nearly-half-49-of-ceos-believe-most-or-all-of-their-role-should-be-automated-or-replaced-by-ai https://press.edx.org/edx-survey-finds-nearly-half-49-of-ceos-believe-most-or-all-of-their-role-should-be-automated-or-replaced-by-ai https://press.edx.org/edx-survey-finds-nearly-half-49-of-ceos-believe-most-or-all-of-their-role-should-be-automated-or-replaced-by-ai https://www.fastcompany.com/91011036/the-5-skills-workers-value-the-most-in-2024-according-to-new-research https://www.fastcompany.com/91011036/the-5-skills-workers-value-the-most-in-2024-according-to-new-research https://www.fastcompany.com/91011036/the-5-skills-workers-value-the-most-in-2024-according-to-new-research https://www.linkedin.com/business/talent/blog/talent-strategy/linkedin-most-in-demand-hard-and-soft-skills https://www.linkedin.com/business/talent/blog/talent-strategy/linkedin-most-in-demand-hard-and-soft-skills https://www.linkedin.com/business/talent/blog/talent-strategy/linkedin-most-in-demand-hard-and-soft-skills https://yourewrongabout.buzzsprout.com/1112270/14627592 https://yourewrongabout.buzzsprout.com/1112270/14627592 american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. a podcast to discuss topics important for the profession of medical writing available on apple podcasts, spotify, youtube podcasts, and trilogywriting.com/trilotalk catch the latest episode: https://trilogywriting.com/trilotalk/ american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. american medical writers association please log in to your amwa member account. username password forgot password? an amwa journal subscription is included with amwa membership. not currently a member? click here to renew or join now. v39 n4 / 2024 ©2024 american medical writers association. all rights reserved. issn 2163-5315 amwajournal.org 53 abstract the purpose of this article is to examine the influence of social determinants of health on the global health problem of cardiovascular disease (cvd), particularly focused on the americas. cvd, encompassing conditions such as coronary heart disease, heart failure, and cerebral vascular disease, is identified as the leading cause of mortality worldwide, with lowand middle-income countries bearing the brunt of its burden. the article discusses how factors such as economic status, education, physical environment, food supply, substance addiction, and health care accessibility contribute to the prevalence of cvd. additionally, it explores current public health policies addressing cvd and provides recommendations for enhancing these policies to alleviate the burden of the disease. the recommendations include implementing tobacco control policies, raising the legal age for purchasing tobacco products, and advocating for comprehensive health care services. the article concludes by emphasizing the importance of tailored interventions, evidence-based policies, and evaluation strategies in combating cvd and improving public health outcomes. public health policies and cardiovascular disease an effective public health policy assists in creating supportive environments that are important in ensuring that people live in a healthy social, emotional, spiritual, physical, and ecological environment that is safe and enjoyable for the greater community. this is achievable if public health policies are developed and established to improve the determinants of health and the subsequent factors that contribute to the overall health status of the individual and community. over time, public health policies should be reviewed to assess their impact on health and, if these policies have a negative impact on health, strategies should be implemented to amend and resolve them.1 historical perspective cardiovascular disease (cvd) is a common theme of public health policy. in the americas, both country-specific strategies and regional approaches have been adapted to maximize the effectiveness of the various policies in tackling the ever-present issue of cvd. during 2007, on a daily average, more than 2,200 americans died of cvd.2 despite this distressing statistic, there has been a notable decline in cvd mortality rates since their peak in the mid-1960s, reflecting sustained progress over decades.3 this decline, particularly noticeable from 1980 to 2000, is attributed to reductions in major cvd risk factors achieved through the implementation of public policies, education campaigns, and evidence-based medical treatments.4 despite initial optimism for sustainable progress, public policy aimed at addressing cvd encountered a critical challenge in 2020. mortality rates among adults continued to rise beyond the early years of the covid-19 pandemic, persisting into 2022 despite the stabilization of the public health emergency. this marked a notable reversal of almost a decade’s worth of progress in reducing cvd mortality rates in the united states. although the exact reasons behind these adverse trends remain unclear, factors such as higher occupational exposure to covid-19, increased financial instability, heightened stress levels, and reduced access to quality health care during the pandemic likely played significant roles.5 moving forward, cvd policies should prioritize a comprehensive approach addressing traditional risk factors and emerging challenges exacerbated by local or global health crises. this includes enhancing public awareness, ensuring equitable access to preventive services, and strengthening health care infrastructure. these efforts should align with the concerns raised by the american heart association regarding projected increases in cvd and associated risk factors in the united states by 2050. high blood pressure prevalence is expected to rise significantly, from 51.2% to 61.0%, leading to over 184 million people diagnosed with cvd, up from 128 million in 2020. cvd, excluding high alan silburn, mph, bp, bn, fawm / western sydney university, campbelltown, australia cardiovascular disease in the americas: social determinants, public health policies, and recommendations (part 2) science series http://www.amwajournal.org amwajournal.org 54cardiovascular disease in the americas (part 2) blood pressure, is expected to increase from 11.3% to 15.0%, affecting 45 million adults, up from 28 million. stroke cases will nearly double, reaching approximately 20 million adults from 10 million currently. obesity rates are forecasted to increase from 43.1% to 60.6%, impacting over 180 million individuals. meanwhile, diabetes prevalence will rise from 16.3% to 26.8%, affecting more than 80 million people.6 the united states’ approach the us department of health and human services’ a public health action plan to prevent heart disease and stroke employs a comprehensive 6-fold array of intervention approaches to reduce the burden of cvd.7 the plan includes policy and environmental changes to address the fundamental social and environmental conditions that contribute to the early development of cvd. additionally, it promotes population-wide behavioral changes to mitigate the effects of adverse social and environmental conditions. another focus is on detecting and controlling risk factors such as smoking and dietary habits that lead to cvd. the plan also includes emergency care and acute case management for patients, followed by rehabilitation services to help patients regain their quality of life, and concludes with end-of-life care.7 although the public health action plan to prevent heart disease and stroke demonstrates considerable strengths with its diverse approaches to managing cvd progression, it falls short in addressing the causes of cvd.7 this plan lacks a clear strategy to identify and mitigate the root causes of the disease. additionally, it does not adequately account for the necessity of cultural sensitivity and the demographic differences across the united states, which are crucial for the successful implementation of a population-wide approach. in response to these shortcomings, the us department of health and human services has shifted its focus toward effective public health policies aimed at reducing the burden of cvd. this shift is embodied in the healthy people 2020 strategy. the initiative is dedicated to enhancing future cardiovascular health and quality of life by emphasizing the prevention, detection, and treatment of risk factors associated with cvd.8 reducing cvd through tobacco control policies the reduction in cardiovascular risk factors such as tobacco smoking is easily targetable by public policy and poses the greatest population health gain in reducing the burden of cvd. this is evident as the implementation of tobacco control policies has a dramatic impact on the accessibility, promotion, and distribution of tobacco products and can lead to a reduction in overall exposure.9 not only is tobacco a leading cause of cvd, tobacco smoking also has a causality link to many other diseases and adverse health effects that contribute to premature mortality rates around the world. for example, since the implementation of comprehensive tobacco control efforts in the united states, it is estimated that 8 million fewer premature deaths related to smoking have occurred. this remarkable achievement underscores the life-saving impact of robust antitobacco policies.9 similarly, in the americas region, the pan american health organization9 reports substantial progress following the adoption of the framework convention on tobacco control. the americas have made significant strides in implementing various tobacco control measures, such as creating smoke-free environments, mandating graphic health warnings on tobacco products, and banning tobacco advertising, promotion, and sponsorship. the effectiveness of these measures is evident in the continuous decline in cvd mortality rates across all measurable countries in the americas.3 furthermore, the introduction or increase of taxes on tobacco products has proven to be a highly effective tobacco control intervention. a substantial body of evidence conclusively demonstrates that higher taxes on tobacco products lead to a significant decrease in tobacco consumption. by making tobacco products less affordable, higher taxes discourage initiation, promote cessation, and ultimately contribute to the overall decline in smoking rates and related health issues. this evidence-based strategy is a critical component of comprehensive tobacco control programs, offering a powerful tool to reduce the burden of tobacco-related diseases and deaths.3,10 recommendations for action in the united states, tobacco products are taxed in 2 ways: per unit (ie, per pack of cigarettes) and the ad valorem tax, which is based on a constant fraction of the wholesale or retail price.11 therefore, a policy recommendation can be made to call upon the local, state, and federal governments to increase the tax applied to tobacco-related products to discourage the population’s continued consumption. a second policy recommendation is that the legal age for purchasing tobacco-related products be raised to increase the level of difficulty for the adolescent population to obtain tobacco products. by raising the minimum age to purchase tobacco products to 21 years, tobacco sales would decrease by approximately 2% but could have a substantial impact on the prevalence of adolescent tobacco use and dependency by limiting its accessibility,12 thus potentially reducing future cvd incidences. a final policy recommendation is a call to action by the food and drug administration in the united states to implement the complete abolition of tobacco product sales. http://www.amwajournal.org amwajournal.org 55cardiovascular disease in the americas (part 2) cigarettes are addictive by design and termed as a defective product, meaning that they are unreasonably dangerous, because it is the leading cause of death for more than half of its long-term consumers.13 not only is the death of millions of people around the world an issue, but tobacco smoking also enforces an enormous financial burden on the economy due to the subsequent health care costs and loss of labor productivity.13 it is an assumption that if the united states were to implement a complete abolition of tobacco product sales, the remaining countries of the americas region would in time follow suit. insights for health education specialists and promotion professionals this article offers a wealth of insights that can significantly benefit certified health education specialists (ches), health education, and health promotion professionals in their efforts to design, implement, and evaluate interventions aimed at controlling or delaying the onset of chronic diseases, with a specific focus on cvd. the following sections highlight the ways in which this research can be instrumental in their respective roles. designing effective interventions one critical aspect explored in this article is the substantial impact of social determinants of health on the prevalence of cvd. this understanding is paramount for ches and health education professionals when devising interventions. armed with this knowledge, they can tailor their programs to address specific determinants, such as economic factors, education, food supply, substance addiction, and health care accessibility. by targeting these determinants, they can design interventions that are more effective in preventing cvd within the americas. as underscored in this research, the prevalence of cvd and its determinants exhibit significant variations across countries and regions. this highlights the necessity for tailored intervention strategies. ches and health promotion professionals can draw from this article to design interventions that are culturally and regionally appropriate, increasing the likelihood of their success. implementing evidence-based interventions this article provides valuable policy recommendations, particularly in the context of tobacco control, a major contributor to cvd. ches and health education professionals can leverage these recommendations as a foundation for developing and advocating for policies within their respective regions or communities. the implementation of such policies can significantly contribute to reducing the incidence of cvd by addressing a significant risk factor. this knowledge can guide professionals in implementing effective tobacco control interventions. strategies like establishing smoke-free environments, promoting graphic health warnings, and advocating for bans on tobacco advertising can be instrumental in reducing tobacco use and its associated health risks. evaluating intervention success the tangible impact of tobacco control policies on cvd mortality rates was discussed. ches and health promotion professionals can use this as a model for evaluating the effectiveness of their interventions. by tracking changes in cvd rates and other relevant health indicators, they can assess the success of their programs. for professionals involved in advocating and implementing policies, this research emphasizes the critical importance of evaluating policy outcomes. by examining the effects of tobacco control policies on cvd mortality, ches and health promotion specialists can demonstrate the success of their efforts and make necessary refinements to their strategies. in summary, this article serves as an invaluable resource for ches and health education and health promotion professionals by offering comprehensive insights into the social determinants of cvd, the impact of public health policies, and policy recommendations. these insights can guide the design, implementation, and evaluation of interventions aimed at controlling or delaying the onset of chronic diseases. in doing so, they contribute to the improvement of health outcomes and the reduction of health disparities within communities and regions. conclusions cvd is the leading cause of morbidity and mortality that affects the worldwide population.14 currently, cvd accounts for 31% of the overall global deaths; however, as research suggests, lowand middle-income countries have a higher susceptibility to cvd, accounting for 80% of these deaths.15 the global health problem of cvd is influenced by the social determinants of health such as the economy, physical environment, education, food supply, substance addiction, and the accessibility of appropriate health care services. therefore, it is a consideration that a multitude of public health policies are necessary for the effective response to the broad burden of cvd among the population of the americas. moreover, the insights provided in this article are invaluable to medical communicators. by understanding the complex interplay of social determinants and cvd, medical communicators can craft more precise, impactful messages that resonate with diverse populations. this information enables them to highlight the importance of tailored interventions and evidence-based policies in combating cvd. http://www.amwajournal.org amwajournal.org 56cardiovascular disease in the americas (part 2) medical communicators can also leverage these findings to advocate for specific public health policies, such as tobacco control measures, that have proven effective in reducing cvd prevalence.9 by disseminating this crucial information clearly and persuasively, medical communicators play a vital role in educating the public, influencing health behaviors, and ultimately contributing to improved public health outcomes. author statement this study did not require ethical approval as it involved a retrospective analysis of publicly available and anonymized data, with no direct involvement of human subjects. author declaration and disclosures: all individuals listed as authors participated sufficiently in the intellectual content, writing, and data analysis of the manuscript to assume public responsibility for the content therein; that all authors reviewed the final version prior to submission; and that any financial or personal relationships that might bias or be seen to bias their contributions to the work have been disclosed. author contact: alan.silburn@health.nsw.gov.au references 1. ward bm, verrinder g. young people and alcohol misuse: how can nurses use the ottawa charter for health promotion? aust j adv nurs. 2007; 25(4):114-119. 2. institute of medicine. a nationwide framework for surveillance of cardiovascular and chronic lung diseases. national academies press; 2011. 3. gawryszewski vp, de souza mdfm. mortality due to cardiovascular diseases in the americas by region, 2000-2009. sao paulo med j. 2014;132(2):105-110. 4. ford es, ajani ua, croft jb, et al. explaining the decrease in u.s. deaths from coronary disease, 1980–2000. n engl j med. 2007;356(23):2388-2398. 5. woodruff rc, tong x, khan ss, et al. trends in cardiovascular disease mortality rates and excess deaths, 2010–2022. am j prev med. 2023;66(4):582-589. 6. joynt ke, mitchell s.v. elkind, aparicio hj, et al. forecasting the burden of cardiovascular disease and stroke in the united states through 2050—prevalence of risk factors and disease: a presidential advisory from the american heart association. circulation. 2024;150(4):e65-e88. 7. chukwura j, fay mm, labarthe d. a public health action plan to prevent heart disease and stroke. centers for disease control and prevention; 2003. accessedseptember 25, 2024. https://stacks. cdc.gov/view/cdc/136468/cdc_136468_ds1.pdf 8. healthy people 2020: heart disease and stroke. office of disease prevention and health promotion. published 2014. accessed september 25, 2024. https://wayback.archive-it. 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https://www.who.int/health-topics/ cardiovascular-diseases#tab=tab_1 15. what we’re doing about cardiovascular conditions. australian government department of health and aged care. updated september 29, 2021. accessed september 25, 2024. https:// www.health.gov.au/topics/chronic-conditions/whatwere-doing-about-chronic-conditions/what-were-doingabout-cardiovascular-conditions?utm_source=health.gov. au&utm_medium=callout-auto-custom&utm_campaign=digital_ transformation http://www.amwajournal.org https://stacks.cdc.gov/view/cdc/136468/cdc_136468_ds1.pdf https://stacks.cdc.gov/view/cdc/136468/cdc_136468_ds1.pdf https://wayback.archive-it.org/5774/20220413181905/https://www.healthypeople.gov/2020/topics-objectives/topic/heart-disease-and-stroke https://wayback.archive-it.org/5774/20220413181905/https://www.healthypeople.gov/2020/topics-objectives/topic/heart-disease-and-stroke https://wayback.archive-it.org/5774/20220413181905/https://www.healthypeople.gov/2020/topics-objectives/topic/heart-disease-and-stroke https://iris.paho.org/bitstream/handle/10665.2/28393/9789275118863_eng.pdf https://iris.paho.org/bitstream/handle/10665.2/28393/9789275118863_eng.pdf https://www.who.int/health-topics/cardiovascular-diseases#tab=tab_1 https://www.who.int/health-topics/cardiovascular-diseases#tab=tab_1 https://www.health.gov.au/topics/chronic-conditions/what-were-doing-about-chronic-conditions/what-were-doing-about-cardiovascular-conditions?utm_source=health.gov.au&utm_medium=callout-auto-custom&utm_campaign=digital_transformation https://www.health.gov.au/topics/chronic-conditions/what-were-doing-about-chronic-conditions/what-were-doing-about-cardiovascular-conditions?utm_source=health.gov.au&utm_medium=callout-auto-custom&utm_campaign=digital_transformation https://www.health.gov.au/topics/chronic-conditions/what-were-doing-about-chronic-conditions/what-were-doing-about-cardiovascular-conditions?utm_source=health.gov.au&utm_medium=callout-auto-custom&utm_campaign=digital_transformation https://www.health.gov.au/topics/chronic-conditions/what-were-doing-about-chronic-conditions/what-were-doing-about-cardiovascular-conditions?utm_source=health.gov.au&utm_medium=callout-auto-custom&utm_campaign=digital_transformation https://www.health.gov.au/topics/chronic-conditions/what-were-doing-about-chronic-conditions/what-were-doing-about-cardiovascular-conditions?utm_source=health.gov.au&utm_medium=callout-auto-custom&utm_campaign=digital_transformation https://www.health.gov.au/topics/chronic-conditions/what-were-doing-about-chronic-conditions/what-were-doing-about-cardiovascular-conditions?utm_source=health.gov.au&utm_medium=callout-auto-custom&utm_campaign=digital_transformation american medical writers association please log in to your amwa 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