Ira Mills, PhD, PAREXEL International
The question of how much value professional medical writers add to the development of medical publications has arisen regularly over the past couple of decades, and recent studies have aimed to provide an answer. The American Medical Writers Association (AMWA), European Medical Writers Association (EMWA), and International Society for Medical Publication Professionals (ISMPP) Joint Position Statement on the Role of Professional Medical Writers, released in January 2017, went a step further to describe the appropriate role of professional medical writers in the development of medical and scientific publications.
The basic tenets of the role of professional medical writers in supporting authors and sponsors are to generate ethical, accurate, and timely publications. These are achieved by: 1) following Good Publication Practice (GPP3) guidelines and International Committee of Medical Journal Editors (ICMJE) recommendations, 2) consulting appropriate reporting guidelines (eg, Consolidated Standards of Reporting Trials [CONSORT] and others collated by the EQUATOR Network), 3) ensuring that the authors and sponsors are aware of their obligations under the guidelines, and 4) keeping current with advances in medical communications and best practices. These tenets allow for evidence-based scientific assessments of the value of professional medical writers, which have been utilized in several studies over the past few years.
Studies Report on the Value of Professional Medical Writers
Using evidence-based measures, as now defined by the AMWA-EMWA-ISMPP Joint Position Statement, to define the value of professional medical writers was best studied by the earlier work of Gattrell et al. The authors sought to determine adherence to CONSORT guidelines in a cross-sectional study of primary reports of randomized controlled trials with and without professional medical writing support. CONSORT items that were directly assessable for evidence-based analysis were selected, including methodological details (items 6a; 7a; 8a; 8b; 10; 11a; and 11b) (see Figure 1 below). Other assessable measures studied were related to inclusion of materials in the Results section (items 13 and 14a) and other information to support the article (items 23 and 24). CONSORT items to support the Introduction (item 2a, scientific background and explanation of rationale) and the Discussion (items 20, limitations; 21, generalizability; and 22, interpretation) were not assessed; this was by design, limiting the assessment to objectively evaluable data. The findings showed that professional medical writing support was associated with more complete reporting of randomized clinical trials, thus substantiating the favorable contributions of professional medical writers.
Figure 1. Differences in the reporting of CONSORT items between articles with and without acknowledged medical writing support.
Reproduced from: Professional medical writing support and the quality of randomized controlled trial reporting: a cross-sectional study, Gattrell et al, BMJ Open vol 6, pp 1-8, 2016] with permission from BMJ Publishing Group Ltd.
In an earlier study, Jacobs also demonstrated increased adherence to reporting guidelines in publications with professional medical writing support. He studied 241 publications reporting randomized clinical trials published in Current Medical Research and Opinion between October 2004 and August 2009. In testing the contributions of professional medical writers, he similarly examined many of the CONSORT items related to methodological details, inclusion of materials in the Results section, and general information to support the manuscript. Overall, significantly more CONSORT items were completed in the presence of professional medical writing support.
Recently, Mills et al. used a similar approach in conducting a post hoc analysis of professional medical writing contributions using a dataset from a prior study that examined adherence to CONSORT for Abstracts items from 463 randomized controlled trials published in five high-impact journals. A higher adherence to reporting harms and side effects (item 16) and source of funding (item 19) was seen when professional writing support was provided. Conversely, a lower adherence in the reporting of study setting (item 4) was noted. Overall, no difference was observed in adherence across all CONSORT for Abstracts items with and without professional medical writing support; areas to consider for improvement were also identified.
Contributory Role of Professional Medical Writers as Defined by the AMWA-EMWA-ISMPP Joint Position Statement and GPP3
The AMWA-EMWA-ISMPP Joint Position Statement provides an example of suggested language to define a contributory role for professional medical writers: “The authors thank [name and qualifications] of [company, city, country] for providing medical writing support/editorial support [specify and/or expand as appropriate], which was funded by [sponsor, city, country] in accordance with Good Publication Practice (GPP3) guidelines.” The AMWA-EMWA-ISMPP Joint Position Statement also allows for authors who collaborate with professional medical writers to include them as authors, assuming they fulfill ICMJE criteria for same. Likewise, GPP3 states that professional medical writers serve a contributory role in support of authors, while citing some instances of satisfying ICMJE criteria, such as authoring a review article. Survey data, albeit from authors who work with medical communications agencies, suggest that the role of professional medical writers is valued, with good support for professional medical writer authorship most apparent in the cases of systematic and narrative reviews.[6,7]
In the absence of definable metrics to generate evidence-based support of professional medical writing satisfying ICMJE authorship criteria, professional medical writers would be well served to define their roles as primarily contributory, as outlined in the AMWA-EMWA-ISMPP Joint Position Statement and in GPP3.
- AMWA-EMWA-ISMPP joint position statement on the role of professional medical writers. Medical Writing 2017;26:7-8. Available at: http://journal.emwa.org/writing-better/amwa-emwa-ismpp-joint-position-statement-on-the-role-of-professional-medical-writers/. Accessed May 18, 2018.
- Battisti WP, Wager E, Baltzer L, et al. Good publication practice for communicating company-sponsored medical research: GPP3. Ann Intern Med 2015;163:461-464.
- Gattrell WT, Hopewell S, Young K, et al. Professional medical writing support and the quality of randomized controlled trial reporting: a cross-sectional study. BMJ Open 2016;6:e010329. doi: 10.1136/bmjopen-2015-010329.
- Jacobs A. Adherence to the CONSORT guideline in papers written by professional medical writers. Write Stuff 2010;19:196-199.
- Mills I, Sheard C, Hays M, et al. Professional medical writing support and the reporting quality of randomized controlled trial abstracts among high-impact general medical journals. Version 2. F1000Res 2017; Aug 16 [revised 2017 Sept 14];6:1489.
- Marchington JM, Burd GP. Author attitudes to professional medical writing support. Curr Med Res Opin 2014;30:2103-2108.
- Gristwood T, Farrow F, Hill C, et al. When should medical writers be listed as authors? Curr Med Res Op 2014;30(suppl 1):S22.
The author wishes to thank Lawrence Hargett and Megan Misukonis of PAREXEL for providing editorial assistance.