Background
Many clinical trials have assessed treatments for depressive disorders and bipolar depression. However, whether, and which, assessed outcome domains really matter to patients, informal caregivers, and health-care professionals remains unclear.
Methods
We did an international online survey in French, German, and English. Participants were adult patients with a history of depression, informal caregivers, and health-care professionals, recruited by purposeful sampling. To identify outcome domains, participants answered four open-ended questions about their expectations for depression treatment. We disseminated the survey without restriction via social media, patient and professional associations, and a media campaign. Four researchers independently did qualitative content analyses. We assessed data saturation using mathematical models to ensure the comprehensive identification of outcome domains.
Findings
Between April 5, 2018, and Dec 10, 2018, 1912 patients, 464 informal caregivers, and 627 health-care professionals from 52 countries provided 8183 open-ended answers. We identified 80 outcome domains related to symptoms (64 domains), such as mental pain (or psychological or psychic pain, 523 [17%] of 3003 participants) and motivation (384 [13%]), and functioning (16 domains), such as social isolation (541 [18%]). We identified 57 other outcome domains regarding safety of treatment, health care organisation, and social representation, such as stigmatisation (408 [14%]).
Interpretation
This study provides a list of outcome domains important to patients, informal caregivers, and health-care professionals. Unfortunately, many of these domains are rarely measured in clinical trials. Results from this study should set the foundation for a core outcome set for depression.
Astrid Chevance, MD
Prof Philippe Ravaud, PhD
Anneka Tomlinson, PhD
Catherine Le Berre, MD
Birgit Teufer, MA
Suzanne Touboul, PhD
Eiko I Fried, PhD
Prof Gerald Gartlehner, PhD
Prof Andrea Cipriani, PhD
Viet Thi Tran, PhD
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Disease Category: Mental health
Disease Name: Major depressive disorder (MDD), Depression
Age Range: 18 - 65
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Patient perspectives
- Survey
International online survey in French, German, and English.