About Core Outcomes in Menopause (COMMA)
The COMMA project is an international collaboration which aims to develop and disseminate Core Outcome Sets for research in menopause. Menopause is a natural biological event that occurs in all women, and is the time when their menstrual periods stop permanently. Menopause normally occurs between the ages of 45-55. Many women experience symptoms associated with menopause, including hot flushes, night sweats, and symptoms related to vaginal dryness.
The COMMA project is being led by an international team of experts, including menopause clinicians, researchers, and women with experience of menopause
Why does menopause research need a core outcome set?
We need more safe and effective treatments for women experiencing menopause. Understanding what treatments are most effective has been limited because different studies have measured different outcomes. This project is designed to identify what aspects of symptoms are most important for patients, doctors and researchers. A set of CORE outcomes enables researchers to compare different treatments and helps women to choose the most effective treatments for their symptoms.
A core outcome set (COS) is an agreed standardised set of outcomes that should be measured and reported, as a minimum, in all clinical trials in specific areas of health or health care (COMET). The Core Outcome Measures in Effectiveness Trials (COMET) initiative has been established to bring together groups working on developing Core Outcome Sets in different areas of health, and they produce guidelines on how to develop Core Outcome Sets. COMMA is a registered COMET project (registration no. 917).
The existence or use of a core outcome set does not imply that outcomes in a particular study should be restricted to those in the relevant core outcome set. Rather, there is an expectation that the core outcomes will be collected and reported, making it easier for the results of studies to be compared, contrasted and combined as appropriate; while researchers continue to explore other outcomes as well. COMET aims to collate and stimulate relevant resources, both applied and methodological, to facilitate exchange of ideas and information, and to foster methodological research in this area.
To learn more about the purpose and development of Core Outcome Sets, read the COMET information leaflet.
The COMMA Core Outcome Sets
The COMMA project aims to develop Core Outcome Sets relevant for menopause research. As the treatments available tend to differ depending on the type of menopause symptoms experienced, the COMMA project is creating separate Core Outcome Sets for different symptom types.
We are currently working on two Core Outcome Sets
- Core outcomes for vasomotor symptoms of menopause (e.g. hot flushes and night sweats)
- Core outcomes for genitourinary symptoms of menopause (e.g. vaginal dryness)
Progress and timeline
- The COMMA project was established in 2016, and registered with COMET
- Systematic reviews to inform the COMMA project were undertaken in 2018, see publications
- Online Delphi surveys were held in 2019 and 2020
- Consensus meetings to determine the final Core Outcome Sets were held in May 2020
- The next steps is to determine how to measure these Core Outcomes
Prof Martha Hickey, Deputy Head of the Department of Obstetrics and Gynaecology, University of Melbourne, talks about COMMA.
A/Prof Monica Christmas, Assistant Professor of Obstetrics and Gynaecology, Director of the Menopause Program, University of Chicago, talks about menopause