Recommended measurement instruments for menopausal vasomotor symptoms: the COMMA (Core Outcomes in Menopause) consortium

Sarah Lensen, From the Department of Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Australia.
Vincent S. Paramanandam
Michaela Gabes, University Regensburg, Regensburg, Germany.
Gesina Kann, University Regensburg, Regensburg, Germany.
Theresa Donhauser, Institute of Social Medicine and Health Systems Research, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany.
Niamh F. Waters, From the Department of Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Australia.
Anna D. Li, From the Department of Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Australia.
Michelle Peate, From the Department of Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Australia.
Nipuni S. Susanto, From the Department of Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Australia.
Lucy E. Caughey, From the Department of Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Australia.
Fatema Rangoonwal, From the Department of Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Australia.
Jingbo Liu, From the Department of Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Australia.
Patrick Condron, University Library, The University of Melbourne, Parkville, Australia.
Panagiotis Anagnostis, Unit of Reproductive Endocrinology, 1 Department of Obstetrics and Gynecology, Medical School, Aristotle University of Thessaloniki, Thessaloniki, Greece.
David F. Archer, Department of Obstetrics and Gynaecology, Eastern Virginia Medical School, Norfolk, VA.
Nancy E. Avis, Wake Forest University School of Medicine, Winston-Salem, NC.
Robin J. Bell, Women's Health Research Program, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
Janet S. Carpenter, School of Nursing, Indiana University, Indianapolis, IN.
Peter Chedraui, Escuela de Posgrado en Salud, Universidad Espíritu Santo, Samborondón, Ecuador.
Monica Christmas, Department of Obstetrics and Gynaecology, University of Chicago, Chicago, IL.
Melanie Davies, Institute for Women's Health, University College London, UK.
Tim Hillard, Department of Obstetrics and Gynaecology, University Hospitals Dorset NHS Trust, Poole, Dorset, UK.
Myra S. Hunter, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Stamatina Iliodromiti, Women's Health Research Unit, Wolfson Institute of Population Health, QMUL, London, United Kingdom.
Nicole G. Jaff, Department of Chemical Pathology, National Health Laboratory Service and University of the Witwatersrand Faculty of Health Sciences, Johannesburg, South Africa.
Unnop Jaisamrarn, Center of Excellence in Menopause and Aging Women Health, Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Hadine Joffe, Connors Center for Women's Health and Gender Biology and the Department of Psychiatry, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Sunila Khandelwal, Department of Obstetrics and Gynaecology, Fortis Escort Hospital, Jaipur, India.
Ludwig Kiesel, Department of Gynaecology and Obstetrics, University of Muenster, Germany.
Pauline M. Maki, University of Illinois at Chicago, Departments of Psychiatry, Psychology and Obstetrics and Gynecology, Chicago, IL.
Gita D. Mishra, Australian Women and Girls' Health Research Centre, School of Public Health, University of Queensland, St Lucia, Australia.
Rossella E. Nappi, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Research Center for Reproductive Medicine, Gynecological Endocrinology and Menopause, IRCCS San Matteo Foundation, Pavia, Italy.

Document Type

Journal Article

Publication Date

4-30-2024

Journal

Menopause (New York, N.Y.)

DOI

10.1097/GME.0000000000002370

Abstract

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.

Department

Obstetrics and Gynecology

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