





































 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 con-

tent 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 sup-

port of CEHP that aims to protect its integrity by erecting a 

firewall between commercial interests and the expert fac-

ulty who deliver instruction to learners. In Standard 2 of its 

Standards for Integrity and Independence in Accredited 

Continuing Education, the ACCME states, “The accred-

ited 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 ineligi-

ble 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 med-

ical writer must not be influenced by any commercial sup-

porter 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 writ-

ten 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 free-

lance 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 them-

selves CME writers. From 2014 to 2019, several CME writ-

ers 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 inde-

pendent reviewers, one from AMWA and one from ACEHP, 

sorted these complaints into categories. The category with 

the greatest number of complaints was “sources and refer-

encing,” 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 prac-

tices? CME writers face many challenges that may impair 

the quality of their work. Training programs, either employ-

er-based or university-based, are scarce. Moreover, sys-

tem-related problems, such as labor market supply and 

demand, industry expectations, or standard project lead 

times, may lie beyond the control of the individual med-

ical writer. Rather than trying to solve these macro-level 

problems, it may be more beneficial to focus on micro-

level 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 writ-

ers has been published4,5 and a training outline for future 

regulatory writers has been developed,6 there is no sim-

ilar model or outline for CME writers. Yet, executives at 

med-ed companies have stated anecdotally that a compe-

tency 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 oppor-

tunities. 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 neces-

sary 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 stake-

holders 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 ques-

tionnaires, the panelists are asked to rate a preliminary set 

of competencies and to suggest any additions. The com-

petencies span the domains mentioned above: knowledge 

areas, skills, attitudes, and deliverables, or KSADs. Each 

successive round of questions contains controlled feed-

back 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 pre-

defined group rating of 4 or higher (out of 5) indicates con-

sensus 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 differ-

ences between subgroups.

HELPING WRITERS MOVE FROM WORST TO BEST
The ACCME has set high ethical standards aimed at pro-

tecting 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, med-

ical 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 compe-

tency model may encourage these future writers to pursue 

excellence in developing high-quality, ethical, and engag-

ing 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/standards-
for-integrity-independence-accredited-ce/standard-2-prevent-
commercial-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/regulatory-
writer-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



