Core Outcome Measures in Effectiveness Trials

Core set of outcomes for adolescents with major depressive disorder: A tool of standardized outcomes for clinical research and practice

General Information

Summary:
Major depressive disorder (MDD) is a common and serious mental disorder in adolescents. Although advancements in core outcome set (COS) development for adult depression is underway, the type of outcomes measured in MDD trials for adolescents differ from those in adult populations. Currently, there is no core outcome set for effectiveness trials in the treatment of adolescent major depressive disorder.

Contributors:
Principal investigators: Martin Offringa & Nancy Butcher
Co-investigators: Andrea Monsour, Emma Mew, Peter Szatmari
Affiliations: Toronto Outcomes Research in Child Health (TORCH), Hospital for Sick Children

Further Study Information

Current Stage:
Ongoing
Date:
February 2018 - February 2020
Funding source(s):
None

Health Area

Disease Category
Mental health

Disease Name
Major depressive disorder (MDD)

Target Population

Age Range
12 - 18

Sex
Either


Nature / type of Intervention
Any

Method(s)

Consensus conference
Delphi process
Interview
Survey
Systematic review

Development of this COS will follow Core Outcome Set-STAndards for Development (COS-STAD) guidelines. To identify existing knowledge about outcomes in adolescent MDD and establish the need for a COS, a systematic scoping review will be conducted. Once outcomes are mapped to an outcome-related framework (e.g., OMERACT filter 2.0), a Delphi process will be conducted to determine which outcomes are core or essential to retain for final discussion at a face-to-face consensus meeting and patient/caregiver interviews. At these final discussions, outcomes will be selected to include in the final COS.


Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)
Epidemiologists
Ethicists
Governmental agencies
Journal editors
Methodologists
Researchers
Service providers
Statisticians

Study Type

COS for clinical trials or clinical research

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