• J Psychosom Res · Jul 2015

    Transparency of outcome reporting and trial registration of randomized controlled trials in top psychosomatic and behavioral health journals: A 5-year follow-up.

    • Kira E Riehm, Marleine Azar, and Brett D Thombs.
    • Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal, Québec, Canada; Department of Psychology, McGill University, Montréal, Québec, Canada.
    • J Psychosom Res. 2015 Jul 1; 79 (1): 1-12.

    ObjectiveThe extent that randomized controlled trials (RCTs) accurately reflect intervention effectiveness depends on the completeness and accuracy of published results. A previous study found that only 40% of 63 RCTs published in top behavioral health journals in 2008-2009 clearly declared primary and secondary outcomes and only 21% were registered. The objective of this study was to conduct a five-year follow-up to assess outcome reporting clarity, proportion of registered trials, and adequacy of outcome registration in RCTs in top behavioral health journals.MethodEligible studies were RCTs published in Annals of Behavioral Medicine, Health Psychology, Journal of Psychosomatic Research, and Psychosomatic Medicine from January 2013 to October 2014.ResultsOf 76 RCT publications reviewed, only 25 (32.9%) adequately declared primary or secondary outcomes, whereas 51 (67.1%) had multiple primary outcomes or did not define outcomes. Of the 76 trials, 40 (52.6%) had been registered. Only 3 studies registered a single primary outcome and time point of assessment prior to enrolling patients, and registered and published outcomes were discrepant in 1 of the 3 studies. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to 5 years prior, the proportion of published trials with adequate outcome declaration decreased from 39.7% to 32.9% (p=0.514). The proportion of registered trials increased from 20.6% to 52.6% (p<0.001).ConclusionThe quality of published outcome declarations and trial registrations remains largely inadequate. Greater attention to trial registration and outcome definition in published reports is needed.Copyright © 2015 Elsevier Inc. All rights reserved.

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