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. 2024 Apr;11(4):285-294.
doi: 10.1016/S2215-0366(23)00438-8.

Heterogeneity of outcome measures in depression trials and the relevance of the content of outcome measures to patients: a systematic review

Christopher Veal  1 , Anneka Tomlinson  2 , Andrea Cipriani  3 , Samuel Bulteau  4 , Chantal Henry  5 , Chlöé Müh  6 , Suzanne Touboul  7 , Nikki De Waal  8 , Hana Levy-Soussan  9 , Toshi A Furukawa  10 , Eiko I Fried  11 , Viet-Thi Tran  1 , Astrid Chevance  12
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Heterogeneity of outcome measures in depression trials and the relevance of the content of outcome measures to patients: a systematic review

Christopher Veal et al. Lancet Psychiatry. 2024 Apr.

Abstract

Research waste occurs when randomised controlled trial (RCT) outcomes are heterogeneous or overlook domains that matter to patients (eg, relating to symptoms or functions). In this systematic review, we reviewed the outcome measures used in 450 RCTs of adult unipolar and bipolar depression registered between 2018 and 2022 and identified 388 different measures. 40% of the RCTs used the same measure (Hamilton Depression Rating Scale [HAMD]). Patients and clinicians matched each item within the 25 most frequently used measures with 80 previously identified domains of depression that matter to patients. Seven (9%) domains were not covered by the 25 most frequently used outcome measures (eg, mental pain and irritability). The HAMD covered a maximum of 47 (59%) of the 80 domains that matter to patients. An interim solution to facilitate evidence synthesis before a core outcome set is developed would be to use the most common measures and choose complementary scales to optimise domain coverage. TRANSLATIONS: For the French and Dutch translations of the abstract see Supplementary Materials section.

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Conflict of interest statement

Declaration of interests AT has received research, educational and consultancy fees from Italian Network for Paediatric Trials (INCiPiT), Angelini Pharma, and Takeda and acted as a clinical advisor for Akrivia Health. ACi has received research, educational and consultancy fees from INCiPiT, the Cariplo Foundation, Lundbeck, and Angelini Pharma; he is also the chief investigator and principal investigator of a trial about seltorexant for adolescents with depression, sponsored by Janssen. SB has received grants from CHU Nantes and the French Ministry of Health and educational fees from Lundbeck and Janssen, outside the submitted work. CH has received educational fees from Lundbeck and Sanofi Aventis. TAF reports personal fees from Boehringer-Ingelheim, DT Axis, Kyoto University Original, Shionogi, SONY, and UpToDate, and a grant from Shionogi, outside the submitted work; in addition, TAF has patents 2020-548587 and 2022-082495 pending and intellectual properties for Kokoro-app, licensed to Mitsubishi-Tanabe. ACi is supported by the National Institute for Health Research (NIHR) Oxford Cognitive Health Clinical Research Facility, an NIHR Research Professorship (grant RP-2017-08-ST2-006), the NIHR Oxford and Thames Valley Applied Research Collaboration, the NIHR Oxford Health Biomedical Research Centre (grant NIHR203316), and Wellcome (GALENOS project). All other authors declare no competing interests.

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