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Commercially Funded and United States-Based Research Is More Likely to Be Published; Good-Quality Studies with Negative Outcomes Are Not
Joseph R. Lynch, MD1; Mary R.A. Cunningham, MD1; Winston J. Warme, MD2; Douglas C. Schaad, PhD3; Fredric M. Wolf, PhD3; Seth S. Leopold, MD1
1 Department of Orthopaedics and Sports Medicine, University of Washington Medical Center, 1959 N.E. Pacific Street, Botx 356500, Seattle, WA 98195. E-mail address for S.S. Leopold: leopold@u.washington.edu
2 Department of Orthopaedic Surgery, William Beaumont Army Medical Center, 5005 North Piedras Street, El Paso, TX 79920
3 Department of Medical Education and Biomedical Informatics, University of Washington Medical Center, 1959 N.E. Pacific Street, Box 357240, Seattle, WA 98195
View Disclosures and Other Information
Disclosure: In support of their research for or preparation of this work, one or more of the authors received, in any one year, outside funding or grants in excess of $10,000 from the University of Washington Friends of Orthopaedic Research and Education Foundation. Neither they nor a member of their immediate families received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. A commercial entity paid or directed in any one year, or agreed to pay or direct, benefits in excess of $10,000 to a research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which the authors, or a member of their immediate families, are affiliated or associated. Zimmer, Inc., Warsaw, Indiana, made an unrestricted gift to the University of Washington Friends of Orthopaedic Research and Education in 2002.
Investigation performed at the Department of Orthopaedics and Sports Medicine, University of Washington Medical Center, Seattle, Washington

The Journal of Bone and Joint Surgery, Incorporated
J Bone Joint Surg Am, 2007 May 01;89(5):1010-1018. doi: 10.2106/JBJS.F.01152
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Abstract

Background: Prior studies implying associations between receipt of commercial funding and positive (significant and/or pro-industry) research outcomes have analyzed only published papers, which is an insufficiently robust approach for assessing publication bias. In this study, we tested the following hypotheses regarding orthopaedic manuscripts submitted for review: (1) nonscientific variables, including receipt of commercial funding, affect the likelihood that a peer-reviewed submission will conclude with a report of a positive study outcome, and (2) positive outcomes and other, nonscientific variables are associated with acceptance for publication.

Methods: All manuscripts about hip or knee arthroplasty that were submitted to The Journal of Bone and Joint Surgery, American Volume, over seventeen months were evaluated to determine the study design, quality, and outcome. Analyses were carried out to identify associations between scientific factors (sample size, study quality, and level of evidence) and study outcome as well as between non-scientific factors (funding source and country of origin) and study outcome. Analyses were also performed to determine whether outcome, scientific factors, or nonscientific variables were associated with acceptance for publication.

Results: Two hundred and nine manuscripts were reviewed. Commercial funding was not found to be associated with a positive study outcome (p = 0.668). Studies with a positive outcome were no more likely to be published than were those with a negative outcome (p = 0.410). Studies with a negative outcome were of higher quality (p = 0.003) and included larger sample sizes (p = 0.05). Commercially funded (p = 0.027) and United States-based (p = 0.020) studies were more likely to be published, even though those studies were not associated with higher quality, larger sample sizes, or lower levels of evidence (p = 0.24 to 0.79).

Conclusions: Commercially funded studies submitted for review were not more likely to conclude with a positive outcome than were nonfunded studies, and studies with a positive outcome were no more likely to be published than were studies with a negative outcome. These findings contradict those of most previous analyses of published (rather than submitted) research. Commercial funding and the country of origin predict publication following peer review beyond what would be expected on the basis of study quality. Studies with a negative outcome, although seemingly superior in quality, fared no better than studies with a positive outcome in the peer-review process; this may result in inflation of apparent treatment effects when the published literature is subjected to meta-analysis.

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    Accreditation Statement
    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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