Protocol for development of a core outcome set for menopausal symptoms (COMMA)

Area of Science:

• Gynecology and Obstetrics
• Clinical Trials Methodology

Background:

• Menopause symptoms like hot flashes and genitourinary issues significantly impact women's quality of life.
• Current research on menopause symptom treatments lacks standardized outcome measures, hindering data comparison and synthesis.
• Inconsistent outcome reporting across randomized trials complicates evaluating intervention safety and effectiveness.

Purpose of the Study:

• To develop a consensus-based Core Outcome Set (COS) for menopausal symptoms.
• To establish a standardized set of outcomes and measures for future clinical trials on menopause symptom interventions.

Main Methods:

• Systematic literature review to identify reported outcomes in intervention trials for vasomotor and genitourinary symptoms.
• Two-round modified Delphi survey involving clinicians, researchers, and consumers (women experiencing menopause) to prioritize outcomes.
• Consensus meeting with stakeholder representatives to finalize the Core Outcome Set.

Main Results:

• An agreed-upon set of minimum outcomes and outcome measures will be established.
• This standardization will facilitate the combination and comparison of findings from future treatment trials.

Conclusions:

• The developed Core Outcome Set will enhance the selection of effective menopause treatments for women and clinicians.
• It aims to improve clinical trial reporting quality, reduce research waste, and ultimately improve care for women with menopausal symptoms.