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

Christopher Veal; Anneka Tomlinson; Andrea Cipriani; Samuel Bulteau; Chantal Henry; Chlöé Müh; Suzanne Touboul; Nikki De Waal; Hana Levy-Soussan; Toshi A Furukawa; Eiko I Fried; Viet-Thi Tran; Astrid Chevance

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

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

Authors

Affiliations

¹ Université Paris Cité and Université Sorbonne Paris Nord, INSERM INRAE, Centre for Research in Epidemiology and Statistics, Paris, France; Centre d'Epidémiologie Clinique, AP-HP, Hôpital Hôtel Dieu, Paris, France.
² Department of Psychiatry, University of Oxford, Oxford, UK.
³ Department of Psychiatry, University of Oxford, Oxford, UK; Oxford Precision Psychiatry Lab, NIHR Oxford Health Biomedical Research Centre, Oxford, UK; Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.
⁴ UMR INSERM 1246, SPHERE, University of Nantes and University of Tours, Nantes, France; CHU Nantes, Department of Addictology, Psychiatry and Old Age Psychiatry, Nantes, France.
⁵ Université Paris Cité, Paris, France; Department of Psychiatry, Service Hospitalo-Universitaire, GHU Paris Psychiatrie and Neurosciences, Paris, France.
⁶ Perception and Memory Unit, Institut Pasteur, UMR3571, CNRS, Paris, France; Université Paris Cité, Collège Doctoral, Paris, France.
⁷ Paris, France.
⁸ Amsterdam, Netherlands.
⁹ La Maison Perchée, Paris, France.
¹⁰ Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Kyoto, Japan.
¹¹ Clinical Psychology Unit, Psychology Department, Leiden University, Leiden, Netherlands.
¹² Université Paris Cité and Université Sorbonne Paris Nord, INSERM INRAE, Centre for Research in Epidemiology and Statistics, Paris, France; Centre d'Epidémiologie Clinique, AP-HP, Hôpital Hôtel Dieu, Paris, France. Electronic address: astrid.chevance@gmail.com.

PMID: 38490761
DOI: 10.1016/S2215-0366(23)00438-8

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.

Publication types

Systematic Review
Review

MeSH terms

Adult
Bipolar Disorder* / diagnosis
Bipolar Disorder* / therapy
Depression* / diagnosis
Humans
Outcome Assessment, Health Care
Patients