Abstract / Summary
Background: Menopause affects more than one billion individuals worldwide, yet outcome measurement in research remains narrow, inconsistent, and largely focused on vasomotor and genitourinary symptoms. Existing frameworks do not adequately capture the broader functional and psychosocial impacts reported by patients. We aimed to develop and validate a global Core Patient-Reported Outcome Set for Menopause (cPRO-MARiE) using prospective mixed-methods data from thirteen countries.
Methods: We analysed quantitative data from 5,228 participants and qualitative interviews from 302 individuals across thirteen countries spanning diverse socio-cultural and health-system contexts. Validated instruments assessed symptom severity, psychological wellbeing, cognitive function, sleep disturbance, pain and somatic symptoms, and functional outcomes. Qualitative data underwent reflexive thematic analysis guided by the Delanerolle–Phiri framework. A COMET-aligned process integrating quantitative severity patterns, qualitative thematic convergence, cross-country reproducibility, psychometric validation and equity considerations was applied to derive the core outcome set.
Findings: Seven domains were consistently identified across all settings: sleep disturbance; psychological wellbeing; cognitive function; pain and somatic symptoms; vasomotor symptoms; genitourinary and sexual health; and social, relational and occupational functioning. These domains demonstrated conceptual stability, cross-country reproducibility and psychometric coherence and were strongly linked to functional impact. The resulting cPRO-MARiE specifies mandatory Tier 1 patient-reported outcomes within each domain, with Tier 2 outcomes retained for context-specific and equity-focused research. Interpretation: cPRO-MARiE is the first empirically derived, globally validated core outcome set for menopause. By capturing symptom domains and functional impacts prioritised by patients across diverse settings, it provides a robust and clinically meaningful framework for outcome measurement in research, routine care, and health-system evaluation.