New methods for the development of Core Outcome Set: the example of depression

Depression is the most prevalent mental disorder worldwide. It has a major impact on daily living to the point of disability. There is, for now, no Core Outcome Set for depression grounded in a large international consensus that includes patients, clinicians and informal caregivers. There is a need to evaluate therapeutic interventions for depression with outcomes which are relevant for the patients, in order to improve shared-decision making.


Principal inverstigator: Astrid Chevance
Supervisor: Philippe Ravaud

Affiliations: METHODS team, CRESS, INSERM U1153 (Paris, France), Paris-Descartes University (Paris, France)

Further Study Information

Current Stage: Ongoing
Date: January 2018 - November 2020
Funding source(s): Fondation pour la recherche médicale

Health Area

Disease Category: Mental health

Disease Name: Major depressive disorder (MDD)

Target Population

Age Range: 18 - 65

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Charities
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Economists
- Epidemiologists
- Families
- Methodologists
- Patient/ support group representatives
- Researchers
- Service providers
- Service users
- Statisticians

Study Type

- COS for clinical trials or clinical research
- COS for practice
- Recommendations for outcome measures (measurement/how)


- Consensus meeting
- Interview
- Literature review
- Survey
- Systematic review

The COS will be developed across 4 phases:
-methodological review of the diversity of outcomes used in the clinical trials and their meta-analysis for depression
-identification of the diversity of expectations of patients, their informal caregivers and clinicians about therapeutic interventions for depression
-matching of outcome domains with outcome measurement tools.
-Selection of the outcomes to be included in the core outcome set