The updated Good Publication Practice guideline (GPP3) acknowledges the legitimate role of medical writers in helping authors with compliant, complete, and timely development of publications, “particularly when authors have limited time or lack knowledge of publication ethics and current publication and reporting guidelines.”1 Indeed, most authors (>84%) recently surveyed value the assistance provided by professional medical writers, particularly in editing manuscripts and ensuring conformity with reporting guidelines.2,3 In addition, emerging evidence suggests that the use of professional medical writers may enhance publication quality.1 So what impact does the medical writer really have on the quality of the publication? That is the question asked by William Gattrell and colleagues in their paper recently published in BMJ Open.4
Their cross-sectional study examined the relationship between medical writing support and the quality and timeliness of randomized controlled trial (RCT) reports. Completeness of the manuscript was assessed based on a predefined subset of 12 typically underreported items from the Consolidated Standards of Reporting Trials (CONSORT) checklist. Time from manuscript submission to editorial acceptance was also measured, as was the overall quality of written English as assessed by peer reviewers.
The authors examined primary reports of RCTs published in 74 BioMed Central journals from 2000 to July 16, 2014, subdividing the articles into those developed with (n=110) or without (n=123) disclosed medical writing support. Their findings indicate that articles written with medical writing support are more likely to be complete and well written compared with those with no writing support.
The most important finding of the study is that articles written with writing support tended to be more complete in their reporting of key information. In a subanalysis looking at industry-funded articles, those with writing support were more than twice as likely as those without writing support to completely report at least 50% of the 12 CONSORT items that are typically underreported. Further, a logistic regression analysis showed that the quality of reporting improved each year for articles with medical writing support versus those without.
The authors also found that articles disclosing medical writing support were more likely to have acceptable written English. As rated by peer reviewers, 81% of articles with writing support had acceptable written English compared with 48% of articles without writing support.
Although the median time from submission to acceptance was 31 days longer for articles using medical writing support, the authors found that those articles tended to be more complex and that the delay was likely due to additional time required for peer review and for the authors to respond to reviewer comments.
Based on their analysis, Gattrell and colleagues concluded that there are sound reasons to believe that the involvement of professional medical writers improves the overall quality of articles and may improve the completeness of clinical trial reporting.
Jim Cozzarin, ELS, MWC™, is a senior editor who brings more than 26 years of editorial expertise to his role in the development of health science communications, publications, and regulatory presentations and submission documents across multiple therapeutic areas, including oncology, respiratory, hematology, allergy, and cardiovascular. Connect with Jim on LinkedIn.
- 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.
- Marchington JM, Burd GP. Author attitudes to professional medical writing support. Curr Med Res Opin. 2014;30:2103-2108.
- Camby I, Delpire V, Rouxhet L, et al. Publication practices and standards: recommendations from GSK Vaccines’ author survey. Trials. 2014;15:446.
- 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:e010329. doi:10.1136/bmjopen-2015-010329.