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Selective outcome reporting is common among published randomized trials and is often associated with the reporting of positive study findings. We investigated whether publication of study protocols in publicly accessible formats is associated with the reporting of positive findings. An extended version of the Cochrane highly sensitive search strategy was used to identify reports of randomized trials on cardiovascular disease that were published in December 2012 and indexed in PubMed by November 2013. Study characteristics and methodologic characteristics were extracted in duplicate. The Fisher's exact test and multivariable logistic regression were used to compare characteristics between trials that reported a publicly accessible protocol and those that did not. One hundred ninety-one reports of cardiovascular randomized trials were identified, 23 (12%) of which reported an accessible protocol. Trials reporting an accessible protocol were significantly larger and more likely to report strong trial methods, including reporting a power calculation, attrition, and the use of an intention-to-treat analysis. Despite greater statistical power, trials reporting an accessible protocol were less likely to report positive findings after controlling for known confounders (odds ratio 0.35, 95% confidence interval 0.13 to 0.94). Reporting of an accessible protocol is associated with a reduced likelihood of reporting positive findings. Further investigation is needed to determine if this association is causal.

Original publication

DOI

10.1016/j.amjcard.2015.07.046

Type

Journal article

Journal

The American journal of cardiology

Publication Date

10/2015

Volume

116

Pages

1280 - 1283

Addresses

Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom; Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.

Keywords

Humans, Cardiovascular Diseases, Clinical Protocols, Logistic Models, Epidemiologic Studies, Research Design, Access to Information, Outcome Assessment (Health Care), Randomized Controlled Trials as Topic, Open Access Publishing