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Clinical trial registries are of minimal use for identifying selective outcome and analysis reporting
Author(s) -
Norris Susan L.,
Holmer Haley K.,
Fu Rongwei,
Ogden Lauren A.,
Viswanathan Meera S.,
AbouSetta Ahmed M.
Publication year - 2014
Publication title -
research synthesis methods
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.376
H-Index - 35
eISSN - 1759-2887
pISSN - 1759-2879
DOI - 10.1002/jrsm.1113
Subject(s) - outcome (game theory) , medicine , randomized controlled trial , sample size determination , clinical trial , index (typography) , meta analysis , medline , statistics , computer science , mathematics , mathematical economics , world wide web , political science , law
Objective This study aimed to examine selective outcome reporting (SOR) and selective analysis reporting (SAR) in randomized controlled trials (RCTs) and to explore the usefulness of trial registries for identifying SOR and SAR. Study Design and Setting We selected one “index outcome” for each of three comparative effectiveness reviews (CERs) of pharmacotherapy and extracted data on this outcome from trial registries and from study publications. Results Among 50 RCTs published since 2005 and reporting the index outcome, only 50% were listed in registries; 90% of RCTs were assessed as having SOR or SAR. The index outcome in the registry was different from that in the publication in 75% of trials in two CERs, and not specified at all in the third. Reported outcomes and analyses were not consistent between the publication's methods section and the results section in 33% and 46% of the two CERs where the index outcome was a benefit. There were no statistically significant predictors of SOR and SAR in our small sample where some predictors lacked variability. Conclusion The SOR and SAR were frequent in this pilot study, and the most common type of SOR was the publication of outcomes that were not pre‐specified. Trial registries were of little use in identifying SOR and of no use in identifying SAR. Copyright © 2014 John Wiley & Sons, Ltd.