Core Outcome Sets (COS)

A Core Outcome Set (COS) is an agreed upon, standardized, minimal set of outcomes that should be measured and reported in all clinical trials in a specific area of health or health care. Development of a COS ensures consistency, comparability, and relevance across studies.

Why develop a COS?

A COS ensures consistency of outcomes selected and measured across studies (or trials), while still allowing researchers to include additional outcomes relevant to their specific study. While COS development is new to mental health, COS development in other areas of health care has led to:

  • Increases consistency of outcomes selected and measured across studies.

  • Improves ability to conduct a review of results across studies - also know as a systematic review of studies.

  • Ensures that outcomes prioritized by interest holders, including youth and caregivers, are systematically measured and reported across studies.

  • Reduces selective outcome reporting and bias.

Who develops COS?

COS are developed through consensus-building among diverse interest holders, which include:

  • Youth with lived experience of the condition

  • Caregivers of youth with lived experience of the condition

  • Clinicians and researchers

  • Health policy-makers

  • Journal editors and funders

  • Other interest groups

The IN-ROADS & COMPACT initiatives have a strong Family Youth Partner Advisory Committee (FYPAC) who have helped with all aspects and all phases of our COS development.

COS Development

1. Review the Literature

  • Identify what outcomes have been selected and measured to date

  • Assess variability and gaps that exist and determine if a COS is needed

  • Identify the scope of the COS

2. Interest Holder Engagement to Elicit the Important Outcomes

  • Involve youth with lived experience and the caregivers who support them, as well as clinicians, and researchers and other interest groups in all phases of the process of COS development

  • Conduct workshops, interviews, or surveys to gather perspectives on meaningful outcomes

3. Outcome Prioritization Through a Consensus Building Process

  • Use structured methods (e.g., Delphi surveys) to prioritize outcomes based on interest holder input

  • Hold consensus meetings to finalize the outcomes for the COS

4. Identify an Outcome Measurement Instrument for Each Outcome

  • Identify the Outcome Measurement Instruments used to measure outcomes in the final COS

  • Assess the quality of these Outcome Measurement Instruments (OMIs)

  • Use a consensus-based process to identify one OMI for each outcome

5. Implementation and Dissemination

  • Promote dissemination and implementation of the COS in clinical trials and research protocols

  • Monitor usage and update the COS as needed