title: Transparency of outcome reporting and trial registration of randomized controlled trials in top psychosomatic and behavioral health journals: A systematic review.
abstract: OBJECTIVE
  The most reliable evidence for evaluating healthcare interventions comes from well-designed and conducted randomized controlled trials (RCTs). The extent to which published RCTs reflect the efficacy of interventions, however, depends on the completeness and accuracy of published results. The Consolidated Standards of Reporting Trials statement, initially developed in 1996, provides guidelines intended to improve the transparency of published RCT reports. A policy of the International Committee of Medical Journal Editors, initiated in 2005, requires clinical trials published in member journals to be registered in publicly accessible registries prior to patient enrollment. The objective of this study was to assess the clarity of outcome reporting, proportion of registered trials, and adequacy of outcome registration in RCTs published in top behavioral health journals.
  
  
  METHODS
  Eligible studies were primary or secondary reports of RCTs published in Annals of Behavioral Medicine, Health Psychology, Journal of Psychosomatic Research, and Psychosomatic Medicine from January 2008 to September 2009. Data were extracted for each study on adequacy of outcome reporting and registration.
  
  
  RESULTS
  Of 63 articles reviewed, only 25 (39.7%) had adequately declared primary or secondary outcomes, whereas 38 (60.3%) had multiple primary outcomes or did not define outcomes. Only 13 studies (20.6%) were registered. Only 1 study registered sufficiently precise outcome information to compare with published outcomes, and registered and published outcomes were discrepant in that study.
  
  
  CONCLUSIONS
  Greater attention to outcome reporting and trial registration by researchers, peer reviewers, and journal editors will increase the likelihood that effective behavioral health interventions are readily identified and made available to patients.
authors.affiliation: Department of Psychiatry, McGill University, Montreal, Quebec, Canada.
authors.forename: Katherine
authors.initials: K
authors.lastname: Milette
authors.forename: Michelle
authors.initials: M
authors.lastname: Roseman
authors.forename: Brett D
authors.initials: BD
authors.lastname: Thombs
mesh_terms: D001524:Behavioral Medicine / Q000379:methods; D030881:Disclosure; D006801:Humans; D010380:Peer Review; D010506:Periodicals as Topic / Q000592:standards*; D057766:Policy; D011786:Quality Control; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D016896:Treatment Outcome