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Recommended measurement instruments for menopausal vasomotor symptoms: the COMMA (Core Outcomes in Menopause)
Sarah Lensen1, Vincent S Paramanandam, Michaela Gabes2
1From the Department of Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Australia.
Insights
This study identified patient-reported outcome measures (PROMs) for menopause vasomotor symptoms, recommending one for distress and sleep impact. However, suitable PROMs for symptom frequency, severity, and treatment satisfaction remain undeveloped.
Area of Science:
- Menopause research
- Clinical trial methodology
- Patient-reported outcomes
Background:
- Vasomotor symptoms are a key concern for women during menopause.
- The COMMA (Core Outcomes in Menopause) project identified six core outcomes for evaluating these symptoms.
- Standardized measurement of these outcomes is crucial for clinical research and practice.
Purpose of the Study:
- To identify appropriate definitions and patient-reported outcome measures (PROMs) for six core menopause vasomotor symptom outcomes.
- To establish consensus on the best methods for measuring symptom frequency, severity, distress, sleep impact, treatment satisfaction, and side effects.
Main Methods:
- A systematic literature review identified definitions and PROMs.
- A global consensus process involving 36 experts from 16 countries reviewed and recommended measures.
- PROMs were evaluated for their relevance to core outcomes and measurement properties.
Main Results:
- 40 PROMs were identified, but only four met the criteria for two core outcomes.
- The Hot Flash Related Daily Interference Scale is recommended for measuring distress/bother/interference and sleep impact.
- Six definitions for 'side effects' were reviewed; reporting adverse events is recommended.
Conclusions:
- Suitable PROMs were identified for only three of the six core outcomes.
- No validated PROMs were found for symptom frequency, severity, or treatment satisfaction.
- Development and validation of new PROMs are needed for the remaining core outcomes.
Objective:
The aim of the study is to identify suitable definitions and patient-reported outcome measures (PROMs) to assess each of the six core outcomes previously identified through the COMMA (Core Outcomes in Menopause) global consensus process relating to vasomotor symptoms: frequency, severity, distress/bother/interference, impact on sleep, satisfaction with treatment, and side effects.
Methods:
A systematic review was conducted to identify relevant definitions for the outcome of side-effects and PROMs with acceptable measurement properties for the remaining five core outcomes. The consensus process, involving 36 participants from 16 countries, was conducted to review definitions and PROMs and make final recommendations for the measurement of each core outcome.
Results:
A total of 21,207 publications were screened from which 119 reporting on 40 PROMs were identified. Of these 40 PROMs, 36 either did not adequately map onto the core outcomes or lacked sufficient measurement properties. Therefore, only four PROMs corresponding to two of the six core outcomes were considered for recommendation. We recommend the Hot Flash Related Daily Interference Scale to measure the domain of distress, bother, or interference of vasomotor symptoms and to capture impact on sleep (one item in the Hot Flash Related Daily Interference Scale captures interference with sleep). Six definitions of "side effects" were identified and considered. We recommend that all trials report adverse events, which is a requirement of Good Clinical Practice.
Conclusions:
We identified suitable definitions and PROMs for only three of the six core outcomes. No suitable PROMs were found for the remaining three outcomes (frequency and severity of vasomotor symptoms and satisfaction with treatment). Future studies should develop and validate PROMs for these outcomes.
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