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

Abstract

Objective: Menopause is the natural cessation of menstruation and may be accompanied by troublesome symptoms including hot flushes and night sweats (vasomotor symptoms) and genitourinary symptoms. Randomized trials evaluating the safety and effectiveness of interventions for these symptoms have reported a wide range of outcomes and used inconsistent measures. This variation precludes comparing and combining data from different trials. To overcome this limitation, we will develop a Core Outcome Set for Menopausal Symptoms. Methods: We will systematically review the literature to identify the outcomes reported in the interventional trials for vasomotor and genitourinary symptoms. This list will be entered into a two-round modified Delphi survey to be completed by clinicians, researchers, and consumers (women who have experienced menopause). Participants will score outcomes on a nine-point scale from “not important” to “critically important.” Representatives from each stakeholder group will then meet to discuss the results and finalize the Core Outcome Set. Ethics approval was not required as this was considered service evaluation and development. The study is registered with the Core Outcome Measures in Effectiveness Trials Initiative ( http://www.comet-initiative.org/studies/details/917 ). Results: An agreed upon set of minimum outcomes and outcome measures will facilitate combining and comparing findings from future trials of treatments for menopausal symptoms. Conclusions: This Core Outcome Set will better enable women and clinicians to select effective treatments, improve the quality of trial reporting, reduce research wastage, and improve care for women with troublesome menopausal symptoms. Video Summary:

A core outcome set for vasomotor symptoms associated with menopause: the COMMA (Core Outcomes in Menopause) global initiative

“…Menopause has been identified as an area of unmet need for a COS because of inconsistent reporting of research outcomes 13 . The COMMA project was guided by robust methodology as recommended by the COMET guidelines, and followed predefined methods as published in our study protocol 11,14 . The methodology included input from a wide range of participants at all stages of the process, including the consensus meetings.…”

“…Following the completion of Round 2, predefined consensus criteria were applied to classify each outcome as: 14 …”

“…The protocol for COMMA has been previously described. 14 The project was prospectively registered with the CROWN and COMET initiatives (registration no. 917).…”

A core outcome set for genitourinary symptoms associated with menopause: the COMMA (Core Outcomes in Menopause) global initiative

“…The COMMA project was prospectively registered with the CROWN and COMET initiatives (registration no. 917), and the protocol has been described previously 11 . Briefly, a COMMA Steering Group was convened to provide oversight on the scope and progress of COMMA.…”

Evidence synthesis in the time of COVID-19

“…The COMET initiative was launched in 2010 [12] and, of relevance to readers of Climacteric, the aspect of COMET relevant to women at midlife is the COMMA (Core Outcomes in Menopause) initiative [13]. Recent work of the COMMA initiative has seen the development of core outcomes for trials evaluating treatments for both vasomotor and genitourinary symptoms of menopause [14], a development which should ensure greater efficiency in the future evaluation of interventions for these conditions.…”