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Primary outcome reporting in clinical trials for older adults with depression
- Myanca Rodrigues, Anna Oprea, Keily Johnson, Alexander Dufort, Nitika Sanger, Pegah Ghiassi, Stephanie Sanger, Balpreet Panesar, Alessia D'Elia, Sameer Parpia, Zainab Samaan, Lehana Thabane
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- Journal:
- BJPsych Open / Volume 10 / Issue 2 / March 2024
- Published online by Cambridge University Press:
- 07 March 2024, e60
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- Article
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Background
Findings from randomised controlled trials (RCTs) are synthesised through meta-analyses, which inform evidence-based decision-making. When key details regarding trial outcomes are not fully reported, knowledge synthesis and uptake of findings into clinical practice are impeded.
AimsOur study assessed reporting of primary outcomes in RCTs for older adults with major depressive disorder (MDD).
MethodTrials published between 2011 and 2021, which assessed any intervention for adults aged ≥65 years with a MDD diagnosis, and that specified a single primary outcome were considered for inclusion in our study. Outcome reporting assessment was conducted independently and in duplicate with a 58-item checklist, used in developing the CONSORT-Outcomes statement, and information in each RCT was scored as ‘fully reported’, ‘partially reported’ or ‘not reported’, as applicable.
ResultsThirty-one of 49 RCTs reported one primary outcome and were included in our study. Most trials (71%) did not fully report over half of the 58 checklist items. Items pertaining to outcome analyses and interpretation were fully reported by 65% or more of trials. Items reported less frequently included: outcome measurement instrument properties (varied from 3 to 30%) and justification of the criteria used to define clinically meaningful change (23%).
ConclusionsThere is variability in how geriatric depression RCTs report primary outcomes, with omission of details regarding measurement, selection, justification and definition of clinically meaningful change. Outcome reporting deficiencies may hinder replicability and synthesis efforts that inform clinical guidelines and decision-making. The CONSORT-Outcomes guideline should be used when reporting geriatric depression RCTs.
Contributors
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- By Shamsuddin Akhtar, Greg Albert, Sidney Allison, Muhammad Anwar, Haruo Arita, Amanda Barker, Mary Hanna Bekhit, Jeanna Blitz, Tyson Bolinske, David Burbulys, Asokumar Buvanendran, Gregory Cain, Keith A. Candiotti, Daniel B. Carr, Derek Chalmers, John Charney, Rex Cheng, Roger Chou, Keun Sam Chung, Anna Clebone, Frederick Conlin, Susan Dabu-Bondoc, Tiffany Denepitiya-Balicki, Jeanette Derdemezi, Anahat Kaur Dhillon, Ho Dzung, Juan Jose Egas, Stephen M. Eskaros, Zhuang T. Fang, Claudia R. Fernandez Robles, Victor A. Filadora, Ellen Flanagan, Dan Froicu, Allison Gandey, Nehal Gatha, Boris Gelman, Christopher Gharibo, Muhammad K. Ghori, Brian Ginsberg, Michael E. Goldberg, Jeff Gudin, Thomas Halaszynski, Martin Hale, Dorothea Hall, Craig T. Hartrick, Justin Hata, Lars E. Helgeson, Joe C. Hong, Richard W. Hong, Balazs Horvath, Eric S. Hsu, Gabriel Jacobs, Jonathan S. Jahr, Rongjie Jaing, Inderjeet Singh Julka, Zeev N. Kain, Clinton Kakazu, Kianusch Kiai, Mary Keyes, Michael M. Kim, Peter G. Lacouture, Ryan Lanier, Vivian K. Lee, Mark J. Lema, Oscar A. de Leon-Casasola, Imanuel Lerman, Philip Levin, Steven Levin, JinLei Li, Eric C. Lin, Sharon Lin, David A. Lindley, Ana M. Lobo, Marisa Lomanto, Mirjana Lovrincevic, Brenda C. McClain, Tariq Malik, Jure Marijic, Joseph Marino, Laura Mechtler, Alan Miller, Carly Miller, Amit Mirchandani, Sukanya Mitra, Fleurise Montecillo, James M. Moore, Debra E. Morrison, Philip F. Morway, Carsten Nadjat-Haiem, Hamid Nourmand, Dana Oprea, Sunil J. Panchal, Edward J. Park, Kathleen Ji Park, Kellie Park, Parisa Partownavid, Akta Patel, Bijal Patel, Komal D. Patel, Neesa Patel, Swati Patel, Paul M. Peloso, Danielle Perret, Anthony DePlato, Marjorie Podraza Stiegler, Despina Psillides, Mamatha Punjala, Johan Raeder, Siamak Rahman, Aziz M. Razzuk, Maggy G. Riad, Kristin L. Richards, R. Todd Rinnier, Ian W. Rodger, Joseph Rosa, Abraham Rosenbaum, Alireza Sadoughi, Veena Salgar, Leslie Schechter, Michael Seneca, Yasser F. Shaheen, James H. Shull, Elizabeth Sinatra, Raymond S. Sinatra, Neil Singla, Neil Sinha, Denis V. Snegovskikh, Dmitri Souzdalnitski, Julie Sramcik, Zoreh Steffens, Alexander Timchenko, Vadim Tokhner, Marc C. Torjman, Co T. Truong, Nalini Vadivelu, Ashley Vaughn, Anjali Vira, Eugene R. Viscusi, Dajie Wang, Shu-ming Wang, J. Michael Watkins-Pitchford, Steven J. Weisman, Ira Whitten, Bryan S. Williams, Jeremy M. Wong, Thomas Wong, Christopher Wray, Yaw Wu, Anthony T. Yarussi, Laurie Yonemoto, Bita H. Zadeh, Jill Zafar, Martha Zegarra, Keren Ziv
- Edited by Raymond S. Sinatra, Jonathan S. Jahr, University of California, Los Angeles, School of Medicine, J. Michael Watkins-Pitchford
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- Book:
- The Essence of Analgesia and Analgesics
- Published online:
- 06 December 2010
- Print publication:
- 14 October 2010, pp xi-xviii
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