• Journal Article

Clinical trial registries are of minimal use for identifying selective outcome and analysis reporting

Citation

Norris, S. L., Holmer, H. K., Fu, R., Ogden, L. A., Viswanathan, M., & Abou-Setta, A. M. (2014). Clinical trial registries are of minimal use for identifying selective outcome and analysis reporting. Research Synthesis Methods, 5(3), 273-284. DOI: 10.1002/jrsm.1113

Abstract

Objective<br>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.<br><br>Study Design and Setting<br>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.<br><br>Results<br>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.<br><br>Conclusion<br>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.