COMMA (Core Outcomes in Menopause): International collaboration to measure core outcomes in menopause

Menopause is a universal event for women. Population based cross-sectional and prospective studies of women going through the menopause transition and randomized controlled trials evaluating treatments for menopausal symptoms have used a wide range of different outcome measures. This variation restricts effective data synthesis limiting the usefulness of research to inform clinical practice. In order to address these methodological concerns, we aim to develop, disseminate, and implement a core outcome set for menopause engaging with key stakeholders, including healthcare professionals, researchers, and women who have experienced the menopause transition. An international steering group has been established, including healthcare professionals, researchers, and patient representatives. Potential outcomes will be identified from systematic review of the literature and will be entered into a modified Delphi method. Key stakeholders will be invited to participate including healthcare professionals, researchers, and consumers. Participants will be invited to score individual outcomes on a seven point Likert scale anchored between one [not important] and seven [critical]. Repeated reflection and rescoring should promote whole and individual stakeholder group converge towards consensus, ‘core’, outcomes. High quality outcome measures will be associated with core outcomes. The implementation of a core outcome set for menopauses within future clinical trials, systematic reviews, and clinical guidelines will enhance the availability of comparable data to facilitate evidence-based patient care

Contributors

Professor Martha Hickey, University of Melbourne, Australia

Further Study Information

Current Stage: Ongoing
Date: September 2016 - April 2020
Funding source(s): To be confirmed


Health Area

Disease Category: Gynaecology

Disease Name: Menopause

Target Population

Age Range: 15 - 60

Sex: Female

Nature of Intervention: Drug, Nonpharmacological

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Epidemiologists
- Governmental agencies
- Journal editors
- Patient/ support group representatives
- Policy makers
- Researchers
- Service providers
- Service users
- Statisticians

Study Type

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

Method(s)

- Consensus conference
- Consensus meeting
- Delphi process
- Focus group(s)
- Interview
- Literature review
- Semi structured discussion
- Systematic review

1. Identify potential core outcome measures for menoapuse
2. Determine the core dataset of minimum outcome measures
3. Achieve consensus on the optimum methods to measure core outcomes