Heterogeneity of outcome measures in depression trials and the relevance of the content of outcome measures to patients: a systematic review.
Journal: The lancet. Psychiatry
Volume: 11
Issue: 4
Year of Publication: 2024
Affiliated Institutions:
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.
Department of Psychiatry, University of Oxford, Oxford, UK.
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.
UMR INSERM , SPHERE, University of Nantes and University of Tours, Nantes, France; CHU Nantes, Department of Addictology, Psychiatry and Old Age Psychiatry, Nantes, France.
Université Paris Cité, Paris, France; Department of Psychiatry, Service Hospitalo-Universitaire, GHU Paris Psychiatrie and Neurosciences, Paris, France.
Perception and Memory Unit, Institut Pasteur, UMR, CNRS, Paris, France; Université Paris Cité, Collège Doctoral, Paris, France.
Paris, France.
Amsterdam, Netherlands.
La Maison Perchée, Paris, France.
Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Kyoto, Japan.
Clinical Psychology Unit, Psychology Department, Leiden University, Leiden, Netherlands.
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.
Abstract summary
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.
Authors & Co-authors:
Veal
Tomlinson
Cipriani
Bulteau
Henry
Müh
Touboul
De Waal
Levy-Soussan
Furukawa
Fried
Tran
Chevance
Study Outcome
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