efficient or the probability.2 Menard states that “the OR can- Financial Disclosures: Dr Ridker reported being listed as a coinventor on patents
held by the Brigham and Women’s Hospital that relate to the use of inflammatory
not take the place of a standardized logistic regression co- biomarkers in cardiovascular disease. The other authors reported no financial dis- efficient for valuating the strength of the influences of the independent variables on the dependent variable, relative 1. Harrell FE Jr. Resampling, validating, describing, and simplifying the model. In:
to one another.” The strength of each independent variable Regression Modeling Strategies. New York, NY: Springer-Verlag New York Inc;2001:97-98.
cannot be judged based on the magnitude of the OR, so thata larger OR for one independent variable might not have astronger association than a smaller OR for another inde- RESEARCH LETTER
The magnitude of the OR should not be used to evaluate Declaration of Medical Writing Assistance
the strength of association for individual independent vari- in International Peer-Reviewed Publications
ables or predictors. In the article by Mora et al, a differentanalysis is needed to assess the strength of association be- To the Editor: Medical researchers have an ethical and sci-
tween the biomarkers and BMI, physical inactivity, or other entific obligation to publish, but between one third and two thirds of research may remain unpublished.1,2 A major rea-son for nonpublication is lack of time,1 which may lead re- Huai Yong Cheng, MD, MPH
searchers to seek medical writing assistance. Guidelines from [email protected]
Department of Medicine

journal editors3 and medical writers4-6 encourage authors to Columbia University Medical Center
acknowledge medical writers. We quantified the propor- New York, NY
tion of articles from international, peer-reviewed, high-ranking journals that reported medical writing assistance.
Financial Disclosures: None reported.
Methods. For this descriptive study, which was con-
1. Mora S, Lee I-M, Buring JE, Ridker PM. Association of physical activity and body
ducted between November 2004 and January 2005, we re- mass index with novel and traditional cardiovascular biomarkers in women. JAMA.
viewed 1000 original research articles from 10 interna- 2. Menard S. Applied Logistic Regression Analysis. 2nd ed. Thousand Oaks, Calif:
tional journals, representing different content areas (TABLE).
Selected journals had to be among the highest ranking jour- In Reply: Dr Cheng raises a statistical concern regarding the
nals in their area (based on the 2003 Institute for Scientific comparison of the magnitude of the ORs for BMI and physi- Information impact factor), be peer-reviewed, publish ac- cal inactivity in relation to cardiovascular biomarkers. We agree knowledgments, and be available online and in English. Ar- that when comparing the association of 2 different measures, ticles were selected in consecutive reverse order, starting with such as BMI and physical inactivity, with a dependent vari- the most recent online edition, until we had 100 articles per able, the 2 measures should be standardized for comparison.
journal. Standardized definitions were used to classify ar- Some investigators argue for using standardized regression co- ticles in terms of declared writing assistance (reference to efficients when comparing the relative contributions of each an individual or organization that assisted with the prepa- measure. However, standardized coefficients have limited ap- ration, writing, technical editing, spelling and grammar plicability to nonnormally distributed predictors.1 In our study, checking, or formatting of the manuscript) and pharma- BMI and physical activity were not normally distributed. For ceutical sponsorship (statement that research was spon- such analyses, it is preferable to calculate the coefficients for sored by a pharmaceutical company, or if 1 or more of the quantiles of BMI and physical inactivity1 as we did in Table 4, authors was a pharmaceutical company employee). Preva- providing an accurate and readily interpretable comparison lence rates and 95% confidence intervals (CIs) were deter- of the 2 measures with respect to their associations with the mined from logistic regression analysis using SAS version cardiovascular biomarkers. From a clinical and public health perspective, we also chose to display the results using clini- Results. Medical writing assistance was reported in only
cal cutpoints for BMI and physical inactivity, as demon- 60 (6.0%) of 1000 articles (95% CI, 4.6%-7.7%). In the sub- set of pharmaceutical-sponsored studies (n = 102), assis- Samia Mora, MD, MHS
tance was declared in 10 articles (9.8%; 95% CI, 4.8%- [email protected]
17.3%). Prevalence varied among journals, from a minimum Center for Cardiovascular Disease Prevention
Brigham and Women’s Hospital
Comment. To our knowledge, this is the first quantifica-
I-Min Lee, MBBS, ScD
tion of the prevalence of declared medical writing assis- Department of Epidemiology
tance in a large cohort of original research articles from in- Harvard School of Public Health
ternational, high-ranking, peer-reviewed journals. We found Paul M Ridker, MD, MPH
a low level of declared medical writing assistance, whether Center for Cardiovascular Disease Prevention
or not articles were based on research with pharmaceutical Brigham and Women’s Hospital
Boston, Mass

932 JAMA, August 23/30, 2006—Vol 296, No. 8 (Reprinted)
2006 American Medical Association. All rights reserved.
Table. Prevalence of Declared Medical Writing Assistance and Industry-Sponsored Research in 1000 Articles From International,
High-Ranking, Peer-Reviewed Journals*
Requirement to
No. of Articles
No. of Articles From
Publication Period
With Declared
Medical Writer‡
of 100 Articles Examined
Medical Writer
American Journal of Kidney Diseases Total (N = 1000)
Abbreviation: NA, not applicable.
*Articles selected in consecutive reverse order, starting with the most recent online edition, until there were 100 articles per journal.
†From the Thomson Institute for Scientific Information’s Journal Citation Reports.
‡Explicit statement within the journal’s “Instructions to Authors” that medical writing assistance should be acknowledged.
§Online edition for February 2005; available in January 2005.
The true prevalence of medical writing assistance comprises cal writing assistance may differ for mid- to low-ranking jour- the prevalence of declared medical writing assistance (6% in nals and for other article types. Although we used informa- our study) and the prevalence of undeclared medical writing tion published in the acknowledgment sections, our results assistance. Estimates for the prevalence of undeclared medi- reflect the information that authors and journals chose to pro- cal writing assistance are based on different information sources.
vide, which may be incomplete. Finally, because we did not In one survey,7 authors admitted that undeclared medical writ- attempt to examine the prevalence of undeclared assistance, ing assistance was involved in only 11 (1.4%) of 809 published additional evidence-based studies are required to quantify its articles. In another survey,8 when authors were specifically asked whether they used but did not declare medical writing assis- Karen L. Woolley, PhD
tance, only 14 (2%) of 810 authors admitted to this practice.
[email protected]
An assertion that 50% or more of drug-related articles in high- ProScribe Medical Communications
ranking journals are prepared with undeclared medical writ- Queensland, Australia
ing assistance9 was not supported by direct evidence.
Julie A. Ely, PhD
Our results may underestimate the true prevalence of medi- ProScribe Medical Communications
cal writing assistance in the published medical literature.
New South Wales, Australia
First, authors may be unaware of the need to declare writ- Mark J. Woolley, PhD
ing assistance. Only 2 of the 10 journals we examined spe- Leigh Findlay, PhD
Felicity A. Lynch, PhD

cifically advised authors to acknowledge writing assistance ProScribe Medical Communications
(Table). Second, authors may be unwilling to declare writ- Queensland, Australia
ing assistance because of the controversy surrounding au- Yoonah Choi, PhD
thorship practices,8 particularly the unethical practice of not ProScribe Medical Communications
declaring assistance (ghostwriting). Third, approximately New South Wales, Australia
40% of authors may be interested in writing assistance to Jane M. McDonald, MBA
help them improve manuscript quality and reduce prepa- ProScribe Medical Communications
ration time.8 Fourth, demand for medical writing services Tokyo, Japan
is growing, with increases in the number of medical writ- 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
ers and the medical writing services market.10 Fifth, pre- liminary evidence suggests that not all medical writers fol- Study concept and design: K. Woolley, Ely, M. Woolley.
low ethical publication guidelines. A pilot survey of medical Acquisition of data: K. Woolley, Ely, M. Woolley, Findlay, Lynch, Choi, McDonald.
Analysis and interpretation of data: K. Woolley, M. Woolley.
writers, who made substantial contributions to manu- Drafting of the manuscript: K. Woolley, M. Woolley.
scripts, found that only approximately 55% encouraged au- Critical revision of the manuscript for important intellectual content: Ely, Find-lay, Lynch, Choi, McDonald.
thors to follow ethical publication guidelines.11 Obtained funding: K. Woolley, M. Woolley.
Our study is limited by our use of high-ranking journals Administrative, technical, or material support: K. Woolley, Ely, M. Woolley, Find-lay, Lynch, Choi, McDonald.
and original research articles; the prevalence of declared medi- Study supervision: K. Woolley, M. Woolley.
2006 American Medical Association. All rights reserved.
(Reprinted) JAMA, August 23/30, 2006—Vol 296, No. 8 933
Financial Disclosures: None reported.
10. Koreith K. Medical writing market appreciation. The Centerwatch Monthly.
Funding/Support: No external funding was used for this study.
2004;11:104. http://www.centerwatch.com/careers/CW1107_medicalwriting Previous Presentation: An abstract of this research was presented at the Fifth In-
ternational Congress on Peer Review and Biomedical Publication; September 16- 11. Hamilton CW, Mallia-Hughes M, Mitrany D, Foote MA. Comments on “The
corporate author” [letter]. J Gen Intern Med. 2005;20:972.
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 theirservices.
Incorrect Data: In the Original Contribution entitled “Fluoxetine After Weight Res-
toration in Anorexia Nervosa” published in the June 14, 2006, issue of JAMA (2006;
1. Camacho LH, Bacik J, Cheung A, Spriggs DR. Presentation and subsequent pub-
295:2605-2612), the boxes in Figure 1 that stated the reasons for premature termi- lication rates of phase I oncology clinical trials. Cancer. 2005;104:1497-1504.
nation for participants taking fluoxetine and placebo were switched. In the box de- 2. Wise P, Drury M. Pharmaceutical trials in general practice: the first 100 pro-
scribing reasons for termination for participants taking the placebo, “Suicide Attempt” tocols: an audit by the clinical research ethics committee of the Royal College of was incorrectly substituted for “Clinical Deterioration.” In Tables 1, 3, and the Mea- General Practitioners. BMJ. 1996;313:1245-1248.
sures section, The Yale Brown Cornell Obsessive Compulsive Scale for Eating Disor- 3. International Committee of Medical Journal Editors. Uniform requirements for
ders should have been termed the Yale-Brown-Cornell Eating Disorder Scale and the manuscripts submitted to biomedical journals: writing and editing for biomedical Eating Disorders Inventory should have been termed the Eating Disorder Inventory.
publication: ethical considerations in the conduct and reporting of research. http: In the Table 2 footnotes, the ␹2 value after “§Proportion of patients with outcome sta- //www.icmje.org/index.html#ethic. Accessed November 1, 2005.
tus of full recovery, good, or fair vs poor with fluoxetine vs placebo” should have been 4. Wager E, Field EA, Grossman L. Good publication practice for pharmaceutical
␹2=1.005. In Table 3, the random-effects regression for the fluoxetine group for the companies. Curr Med Res Opin. 2003;19:149-154.
Eating Disorder Inventory bulimia subscale should have been 0.11 rather than −0.11.
5. Jacobs A, Wager E. European Medical Writers Association (EMWA) guidelines
In the last paragraph of the article, the references 24,25 after “psychological treatments” on the role of medical writers in developing peer-reviewed publications. Curr Med should have been numbered 24 and references 26,27 after “olanzapine” should have been numbered 26. None of these corrections affect the conclusions in the article.
6. Hamilton CW, Royer MG; AMWA 2002 Task Force on the Contributions of
Medical Writers to Scientific Publications. AMWA position statement on the
Error in Wording: In the Editorial entitled “Radiosurgery and Whole-Brain Radia-
contributions of medical writers to scientific publications. AMWA Journal.
tion Therapy for Brain Metastases: Either or Both as the Optimal Treatment” pub- lished in the June 7, 2006, issue of JAMA (2006;295:2535-2536), an error oc- 7. Flanagin A, Carey LA, Fontanarosa PB, et al. Prevalence of articles with hon-
curred in wording. In the final paragraph on page 2536, the term “stereotactic orary authors and ghost authors in peer-reviewed medical journals. JAMA. 1998; radiosurgery” should have been “whole-brain radiation therapy” in both in- stances. The sentence should have read “Aoyama et al10 have prospectively shown 8. Phillips SG, Carey LA, Biedermann G. Attitudes toward writing and writing as-
that withholding whole-brain radiation therapy does not affect survival for pa- sistance in peer-reviewed articles. AMWA Journal. 2001;16:10-16.
tients who have 4 or fewer brain metastases; these patients have a higher rate of 9. Healy DT. Transparency and trust: figure for ghost written articles was mis-
local brain failure, but apparently withholding whole-brain radiation therapy does quoted [letter]. BMJ. 2004;329:1345.
not influence how patients die of their disease.” 934 JAMA, August 23/30, 2006—Vol 296, No. 8 (Reprinted)
2006 American Medical Association. All rights reserved.

Source: http://dcscience.net/wooley-jama-2006.pdf


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