Core Outcome Measures in Effectiveness Trials

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

General Information

Summary:
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.

Contributors:
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 / type of Intervention
Any

Method(s)

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


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
Recommended outcome measures (measurement)

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