title: The roles of funding source, clinical trial outcome, and quality of reporting in orthopedic surgery literature.
abstract: Compared with nonfunded or peer-reviewed funded projects, industry-sponsored clinical trials have traditionally been associated with more positive results. This relationship has been extensively studied in the nonsurgical literature. Although a few authors have addressed specialties, little has been reported on orthopedic clinical trials and their association with funding, study outcome, and efforts to reduce bias after randomization across journals of multiple subspecialties. For the study reported here, we selected 5 major orthopedic subspecialty journals: Journal of Bone and Joint Surgery (American Volume), Spine, Journal of Arthroplasty, Journal of Orthopaedic Trauma, and American Journal of Sports Medicine. We chose a 2-year limit for investigation (2002-2004); included all original randomized clinical trials reported in these 5 journals; and examined these trials for their study design, funding source, outcome, bias potential, and conclusion reached. Support for the 100 eligible orthopedic clinical trials was stated as coming from industry (26 trials, 26%), nonprofit sources (19 trials, 19%), and mixed sources (5 trials, 5%); no support was stated in 46 trials (46%), and support was not reported in 4 trials (4%). Of the 26 trials reporting industry support, 22 (85%) were graded as indicating an outcome favorable to the new treatment. The association between industry funding and favorable outcome was strong and significant (P<.001). In almost half of the studies reported in Journal of Bone and Joint Surgery and Spine, measures taken to reduce bias were not documented.
authors.affiliation: Department of Orthopaedic Surgery, University of California Davis Medical Center, 4860 Y St, Suite 1700, Sacramento, CA 95817, USA. safdar.khan@ucdmc.ucdavis.edu
authors.forename: Safdar N
authors.initials: SN
authors.lastname: Khan
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Mermer
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Myers
authors.forename: Harvinder S
authors.initials: HS
authors.lastname: Sandhu
mesh_terms: D015706:Bibliometrics; D016265:Conflict of Interest; D018849:Controlled Clinical Trials as Topic; D004345:Drug Industry; D005653:Fund Raising / Q000379:methods*; D006801:Humans; D009939:Organizations, Nonprofit; D009985:Orthopedics / Q000706:statistics & numerical data* / Q000639:trends; D017712:Peer Review, Research; D010506:Periodicals as Topic; D011642:Publications / Q000191:economics; D011897:Random Allocation; D012109:Research Support as Topic; D016896:Treatment Outcome