title: Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.
abstract: BACKGROUND
  Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals.
  
  
  METHODS
  Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration.
  
  
  RESULTS
  Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709).
  
  
  CONCLUSIONS
  The quality of published outcome analysis definitions and trial registrations in JCCP is suboptimal. Greater attention to proper trial registration and outcome analysis 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: 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.
authors.forename: Kira E
authors.initials: KE
authors.lastname: Riehm
authors.affiliation: Department of Psychology, Fordham University, Bronx, New York, United States of America.
authors.forename: Dean
authors.initials: D
authors.lastname: McKay
authors.affiliation: Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal, Québec, Canada.|Department of Psychology, McGill University, Montréal, Québec, Canada.|Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montréal, Québec, Canada.|Department of Psychiatry, McGill University, Montréal, Québec, Canada.|Department of Medicine, McGill University, Montréal, Québec, Canada.|Department of Educational and Counselling Psychology, McGill University, Montréal, Québec, Canada.|School of Nursing, McGill University, Montréal, Québec, Canada.
authors.forename: Brett D
authors.initials: BD
authors.lastname: Thombs
mesh_terms: D015706:Bibliometrics; D017408:Guidelines as Topic; D006801:Humans; D017712:Peer Review, Research; D011586:Psychology, Clinical; D016032:Randomized Controlled Trials as Topic; D012958:Societies, Scientific