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To the Editor: Medical researchers have an ethical and scientific obligation to publish, but between one third and two thirds of research may remain unpublished.^1-2 A major reason for nonpublication is lack of time,¹ which may lead researchers to seek medical writing assistance. Guidelines from journal editors³ and medical writers^4-6 encourage authors to acknowledge medical writers. We quantified the proportion of articles from international, peer-reviewed, high-ranking journals that reported medical writing assistance.

Methods
For this descriptive study, which was conducted between November 2004 and January 2005, we reviewed 1000 original research articles from 10 international journals, representing different content areas (Table). Selected journals had to be among the highest ranking journals in their area (based on the 2003 Institute for Scientific Information impact factor), be peer-reviewed, publish acknowledgments, and be available online and in English. Articles were selected in consecutive reverse order, starting with the most recent online edition, until we had 100 articles per journal. Standardized definitions were used to classify articles in terms of declared writing assistance (reference to an individual or organization that assisted with the preparation, writing, technical editing, spelling and grammar checking, or formatting of the manuscript) and pharmaceutical sponsorship (statement that research was sponsored by a pharmaceutical company, or if 1 or more of the authors was a pharmaceutical company employee). Prevalence rates and 95% confidence intervals (CIs) were determined from logistic regression analysis using SAS version 9.1 (SAS Institute, Cary, NC).

View this table: [in this window] [in a new window] [as a PowerPoint slide]   Table. Prevalence of Declared Medical Writing Assistance and Industry-Sponsored Research in 1000 Articles From International, High-Ranking, Peer-Reviewed Journals*

Results
Medical writing assistance was reported in only 60 (6.0%) of 1000 articles (95% CI, 4.6%-7.7%). In the subset of pharmaceutical-sponsored studies (n = 102), assistance was declared in 10 articles (9.8%; 95% CI, 4.8%-17.3%). Prevalence varied among journals, from a minimum of 0% to a maximum of 11%.

Comment
To our knowledge, this is the first quantification of the prevalence of declared medical writing assistance in a large cohort of original research articles from international, high-ranking, peer-reviewed journals. We found a low level of declared medical writing assistance, whether or not articles were based on research with pharmaceutical sponsorship.

The true prevalence of medical writing assistance comprises the prevalence of declared medical writing assistance (6% in our study) and the prevalence of undeclared medical writing assistance. Estimates for the prevalence of undeclared medical writing assistance are based on different information sources. In one survey,⁷ authors admitted that undeclared medical writing assistance was involved in only 11 (1.4%) of 809 published articles. In another survey,⁸ when authors were specifically asked whether they used but did not declare medical writing assistance, only 14 (2%) of 810 authors admitted to this practice. An assertion that 50% or more of drug-related articles in high-ranking journals are prepared with undeclared medical writing assistance⁹ was not supported by direct evidence.

Our results may underestimate the true prevalence of medical writing assistance in the published medical literature. First, authors may be unaware of the need to declare writing assistance. Only 2 of the 10 journals we examined specifically advised authors to acknowledge writing assistance (Table). Second, authors may be unwilling to declare writing assistance because of the controversy surrounding authorship practices,⁸ particularly the unethical practice of not declaring assistance (ghostwriting). Third, approximately 40% of authors may be interested in writing assistance to help them improve manuscript quality and reduce preparation time.⁸ Fourth, demand for medical writing services is growing, with increases in the number of medical writers and the medical writing services market.¹⁰ Fifth, preliminary evidence suggests that not all medical writers follow ethical publication guidelines. A pilot survey of medical writers, who made substantial contributions to manuscripts, found that only approximately 55% encouraged authors to follow ethical publication guidelines.¹¹

Our study is limited by our use of high-ranking journals and original research articles; the prevalence of declared medical writing assistance may differ for mid- to low-ranking journals and for other article types. Although we used information published in the acknowledgment sections, our results reflect the information that authors and journals chose to provide, which may be incomplete. Finally, because we did not attempt to examine the prevalence of undeclared assistance, additional evidence-based studies are required to quantify its extent.

Author Contributions: Dr K. Woolley had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Study concept and design: K. Woolley, Ely, M. Woolley.

Acquisition of data: K. Woolley, Ely, M. Woolley, Findlay, Lynch, Choi, McDonald.

Analysis and interpretation of data: K. Woolley, M. Woolley.

Drafting of the manuscript: K. Woolley, M. Woolley.

Critical revision of the manuscript for important intellectual content: Ely, Findlay, Lynch, Choi, McDonald.

Obtained funding: K. Woolley, M. Woolley.

Administrative, technical, or material support: K. Woolley, Ely, M. Woolley, Findlay, Lynch, Choi, McDonald.

Study supervision: K. Woolley, M. Woolley.

Financial Disclosures: None reported.

Funding/Support: No external funding was used for this study.

Previous Presentation: An abstract of this research was presented at the Fifth International Congress on Peer Review and Biomedical Publication; September 16-18, 2005; Chicago, Ill.

Acknowledgment: We thank Duncan Purvis, PhD, and Christine Wichems, PhD, employees of ProScribe Medical Communications, for their critical review of the manuscript, and John Wlodarczyk, PhD, for calculating the confidence intervals. Drs Purvis, Wichems, and Wlodarczyk received no financial compensation for their services.

Karen L. Woolley, PhD
kw{at}proscribe.com.au
ProScribe Medical Communications
Queensland, Australia

Julie A. Ely, PhD
ProScribe Medical Communications
New South Wales, Australia

Mark J. Woolley, PhD; Leigh Findlay, PhD; Felicity A. Lynch, PhD
ProScribe Medical Communications
Queensland, Australia

Yoonah Choi, PhD
ProScribe Medical Communications
New South Wales, Australia

Jane M. McDonald, MBA
ProScribe Medical Communications
Tokyo, Japan

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JAMA. 2006;296:932-934.

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