Abstract
OBJECTIVE: Assess uptake of the Core Outcomes in Menopause (COMMA) core outcome sets (COS) and examine whether frontline treatments for vasomotor and genitourinary symptoms have been evaluated against these key outcomes.
DESIGN: Methodological review.
SETTING: Published literature and international clinical trial registries.
POPULATION OR SAMPLE: Randomised controlled trials evaluating treatments for vasomotor symptoms or genitourinary symptoms.
METHODS: We explored COS uptake in three ways. First, we reviewed outcome reporting in historical randomised trials. Second, we examined recently registered trials to see whether the COS are being adopted. Finally, we consider how frontline treatments-menopause hormone therapy (MHT) for VMS and vaginal oestrogen for genitourinary symptoms-have been evaluated against these COS.
MAIN OUTCOME MEASURES: Proportion of trial outcomes aligned with the COMMA COS.
RESULTS: Overall, alignment of outcome reporting against the COS was moderate and has increased after publication of the COS. While reporting of the distress, bother or interference caused by these symptoms has historically been rare (2% of trials), 62% of registered clinical trials capture this outcome. Common treatments for VMS and genitourinary symptoms, MHT and vaginal oestrogen, have not been evaluated for all core outcomes, with treatment satisfaction and dysuria reported in only 9% of studies.
CONCLUSION: Despite strong endorsement and improvement in capture of symptom experience and impact, uptake of the full COMMA COS is limited. We call on the menopause research community to prioritise reporting of these outcomes that reflect people's lived experience, so that future evidence is more meaningful, comparable and patient-centred.