title: Transparency of outcome reporting and trial registration of randomized controlled trials in top psychosomatic and behavioral health journals: A 5-year follow-up.
abstract: OBJECTIVE
  The 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.
  
  
  METHODS
  Eligible studies were RCTs published in Annals of Behavioral Medicine, Health Psychology, Journal of Psychosomatic Research, and Psychosomatic Medicine from January 2013 to October 2014.
  
  
  RESULTS
  Of 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).
  
  
  CONCLUSIONS
  The quality of published outcome declarations and trial registrations remains largely inadequate. Greater attention to trial registration and outcome definition in published reports is needed.
authors.affiliation: Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal, Québec, Canada; Department of Psychology, McGill University, Montréal, Québec, Canada.
authors.forename: Kira E
authors.initials: KE
authors.lastname: Riehm
authors.affiliation: Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal, Québec, Canada; Department of Psychology, McGill University, Montréal, Québec, Canada.
authors.forename: Marleine
authors.initials: M
authors.lastname: Azar
authors.affiliation: Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal, Québec, Canada; Department of Psychology, McGill University, Montréal, Québec, Canada; Department of Psychiatry, McGill University, Montréal, Québec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montréal, Québec, Canada; Department of Educational and Counselling Psychology, McGill University, Montréal, Québec, Canada; Department of Medicine, McGill University, Montréal, Québec, Canada; School of Nursing, McGill University, Montréal, Québec, Canada. Electronic address: brett.thombs@mcgill.ca.
authors.forename: Brett D
authors.initials: BD
authors.lastname: Thombs
mesh_terms: D001524:Behavioral Medicine; D005500:Follow-Up Studies; D006801:Humans; D033181:Information Dissemination; D016032:Randomized Controlled Trials as Topic; D012042:Registries
keywords: Behavioral medicine; Bias; Randomized controlled trials; Selective outcome reporting; Trial registration