Kira E Riehm1, Marleine Azar1, Brett D Thombs2. 1. Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal, Québec, Canada; Department of Psychology, McGill University, Montréal, Québec, Canada. 2. 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.
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. METHOD: 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). CONCLUSION: 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.
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. METHOD: 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). CONCLUSION: 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: Marleine Azar; Kira E Riehm; Nazanin Saadat; Tatiana Sanchez; Matthew Chiovitti; Lin Qi; Danielle B Rice; Brooke Levis; Claire Fedoruk; Alexander W Levis; Lorie A Kloda; Jonathan Kimmelman; Andrea Benedetti; Brett D Thombs Journal: JAMA Intern Med Date: 2019-05-01 Impact factor: 21.873
Authors: Stephanie Coronado-Montoya; Alexander W Levis; Linda Kwakkenbos; Russell J Steele; Erick H Turner; Brett D Thombs Journal: PLoS One Date: 2016-04-08 Impact factor: 3.240
Authors: Guowei Li; Luciana P F Abbade; Ikunna Nwosu; Yanling Jin; Alvin Leenus; Muhammad Maaz; Mei Wang; Meha Bhatt; Laura Zielinski; Nitika Sanger; Bianca Bantoto; Candice Luo; Ieta Shams; Hamnah Shahid; Yaping Chang; Guangwen Sun; Lawrence Mbuagbaw; Zainab Samaan; Mitchell A H Levine; Jonathan D Adachi; Lehana Thabane Journal: BMC Med Res Methodol Date: 2018-01-11 Impact factor: 4.615
Authors: Megan A McVay; Kellie B Cooper; Montserrat Carrera Seoane; Marissa L Donahue; Laura D Scherer Journal: Health Psychol Behav Med Date: 2021-04-07
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