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
University of Melbourne
Prof Martha Hickey
Deputy Head, Department of Obstetrics and Gynaecology, University of Melbourne
Dr Sarah Lensen
McKenzie Fellow, Department of Obstetrics and Gynaecology, University of Melbourne
Adjunct Clinical Associate Professor
Endocrinologist, Monash Health Menopause Clinic
Head Early Menopause Research, Monash Centre for Health Research and Implementation Monash University
Vincent Trustees Professor of Obstetrics, Gynecology and Reproductive Biology, Harvard Medical School Director, Massachusetts General Hospital Midlife Women’s Health Center, Boston, MA
Assistant Professor of Obstetrics & Gynecology
Section of Minimally Invasive Gynecology Surgery
Director of the Menopause Program University of Chicago
Associate Professor of Obstetrics, Gynecology and Reproductive Biology
Distinguished Professor, Indiana University
Audrey Geisel Endowed Chair in Innovation, IU School of Nursing
Associate Dean of Research, IU School of Nursing
Mary Ann Lumsden
CEO, International Federation of Obstetrics and Gynaecology (FIGO)
Hon Prof in Obstetrics and Gynaecology, University of Glasgow
Immediate Past President, International Menopause Society
Professor in the Department of Psychiatry, Women’s Mental Health Research, University of Illinois College of Medicine
Emeritus Professor of Clinical Health Psychology, Kings College London
Deputy Director of the Women's Health Research Program in the School of Public Health and Preventive Medicine Monash University in Melbourne, Victoria, Australia
Consultant Gynaecologist, Poole Hospital NHS Trust, Poole, Dorset UK
Board member of International Menopause Society
Past Chairman of the British Menopause Society and current board member
Paula A. Johnson Endowed Associate Professor of Psychiatry in the Field of Women’s Health, Harvard Medical School and Associate Professor, Connors Center for Women’s Health and Gender Biology, Department of Psychiatry, Brigham and Women's Hospital
Red Hot Mamas
Director of the Centre for Women’s Health, Queen Mary University London
Senior Lecturer and Honorary Consultant at the Royal London Hospital
Queen Charlotte's & Chelsea and Westminster Hospitals
Imperial College London
General Secretary, International Menopause Society
Lensen S, Bell RJ, Carpenter JS, Christmas M, Davis SR, Giblin K, Goldstein SR, Hillard T, Hunter MS, Iliodromiti S, Jaisamrarn U, Khandelwal S, Kiesel L, Kim BV, Lumsden MA, Maki PM, Mitchell CM, Nappi RE, Niederberger C, Panay N, Roberts H, Shifren J, Simon JA, Stute P, Vincent A, Wolfman W, Hickey M. A core outcome set for genitourinary symptoms associated with menopause: the COMMA (Core Outcomes in Menopause) global initiative. Menopause. 2021 May 10. doi: 10.1097/GME.0000000000001788. Epub ahead of print. PMID: 33973541.
Lensen S, Archer D, Bell RJ, Carpenter JS, Christmas M, Davis SR, Giblin K, Goldstein SR, Hillard T, Hunter MS, Iliodromiti S, Jaisamrarn U, Joffe H, Khandelwal S, Kiesel L, Kim BV, Lambalk CB, Lumsden MA, Maki PM, Nappi RE, Panay N, Roberts H, Shifren J, Simon JA, Vincent A, Wolfman W, Hickey M. A core outcome set for vasomotor symptoms associated with menopause: the COMMA (Core Outcomes in Menopause) global initiative. Menopause. 2021 Apr 26. doi: 10.1097/GME.0000000000001787. Epub ahead of print. PMID: 33906204.
S Iliodromiti, W Wang, MA Lumsden, MS Hunter, R Bell, G Mishra, M Hickey, the International COMMA (Core Outcomes in Menopause) Consortium. Variation in menopausal vasomotor symptoms outcomes in clinical trials: a systematic review. BJOG 2020 Feb;127(3):320-333. doi: 10.1111/1471-0528.15990.
MM Christmas, B Song, RJ Bell, S Iliodromiti, C Mitchell, M Hickey, and the International COMMA (Core OutcoMes in MenopAuse) Consortium. Variation in outcome reporting and measurement tools in clinical trials of treatments for genitourinary symptoms in peri- and postmenopausal women: a systematic review. Menopause 2020. Vol. 27, No. 9, DOI: 10.1097/GME.0000000000001570
BV Kim, S Iliodromiti, MChristmas, R Bell, S Lensen, M Hickey, on behalf of the International COMMA (Core Outcomes in Menopause) Consortium. Protocol for development of a core outcome set for menopausal symptoms (COMMA). Menopause 2020. Vol. 27, No. 12, pp. 1371-1375 DOI: 10.1097/GME.0000000000001632
- Australasian Menopause Society
- British Menopause Society
- Cochrane Gynaecology and Fertility Group
- Comet Initiative
- Crown - Core Outcomes in Women’s and Newborn Health
- Fertility and Sterility
- HRO – Human Reproduction Open
- IMS – International Menopause Society
- Indian Menopause Society
- The North American Menopause Society
Professor Martha Hickey
BA (Hons), MSc, MBChB, FRANZCOG, FRCOG, MD
Professor of Obstetrics and Gynaecology, Director of the Gynaecology Research Centre, Head of University of Melbourne Department of Obstetrics & Gynaecology (Royal Women’s Hospital)