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

Sarah Lensen; Robin J Bell; Janet S Carpenter; Monica Christmas; Susan R Davis; Karen Giblin; Steven R Goldstein; Tim Hillard; Myra S Hunter; Stamatina Iliodromiti; Unnop Jaisamrarn; Sunila Khandelwal; Ludwig Kiesel; Bobae V Kim; Mary Ann Lumsden; Pauline M Maki; Caroline M Mitchell; Rossella E Nappi; Craig Niederberger; Nick Panay; Helen Roberts; Jan Shifren; James A Simon; Petra Stute; Amanda Vincent; Wendy Wolfman; Martha Hickey

doi:10.1097/GME.0000000000001788

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

Menopause. 2021 May 10;28(8):859-866. doi: 10.1097/GME.0000000000001788.

Authors

Sarah Lensen¹, Robin J Bell², Janet S Carpenter³, Monica Christmas⁴, Susan R Davis², Karen Giblin⁵, Steven R Goldstein⁶, Tim Hillard⁷, Myra S Hunter⁸, Stamatina Iliodromiti⁹, Unnop Jaisamrarn¹⁰, Sunila Khandelwal¹¹, Ludwig Kiesel¹², Bobae V Kim¹³, Mary Ann Lumsden¹⁴, Pauline M Maki¹⁵, Caroline M Mitchell¹⁶, Rossella E Nappi¹⁷, Craig Niederberger¹⁸, Nick Panay¹⁹, Helen Roberts²⁰, Jan Shifren²¹, James A Simon²², Petra Stute²³, Amanda Vincent²⁴, Wendy Wolfman²⁵, Martha Hickey¹

Affiliations

¹ Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Australia.
² Women's Health Research Program, School of Public Health and Preventive Medicine, Monash University. Melbourne, Australia.
³ School of Nursing, Indiana University, Indianapolis, IN.
⁴ Department of Obstetrics and Gynaecology, University of Chicago, Chicago, IL.
⁵ Red Hot Mamas North America, Inc., New York, NY.
⁶ Department of Obstetrics and Gynecology, New York University School of Medicine, New York, NY.
⁷ Department of Obstetrics and Gynaecology, University Hospitals Dorset NHS Trust, Poole, Dorset, UK.
⁸ Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
⁹ Centre for Women's Health, Institute of Population Health Sciences, Queen Mary University London, UK.
¹⁰ Department of Obstetrics and Gynaecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
¹¹ Department of Obstetrics and Gynaecology, Fortis Escort Hospital, Jaipur, India.
¹² Department of Gynaecology and Obstetrics, University of Muenster, Muenster, Germany.
¹³ Adelaide Medical School, Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, Australia.
¹⁴ Department of Reproductive and Maternal Medicine, School of Medicine, University of Glasgow, Glasgow, UK.
¹⁵ Departments of Psychiatry, Psychology and Obstetrics and Gynecology, University of Illinois at Chicago, Chicago IL.
¹⁶ Vincent Center for Reproductive Biology, Massachusetts General Hospital, Boston, MA.
¹⁷ Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, Research Center for Reproductive Medicine, Gynecological Endocrinology and Menopause, IRCCS San Matteo Foundation, University of Pavia, Pavia, Italy.
¹⁸ Department of Urology, UIC College of Medicine, Chicago IL.
¹⁹ Queen Charlotte's and Chelsea and Westminster Hospitals, Imperial College London, London, UK.
²⁰ Auckland District Health Board, Auckland, New Zealand.
²¹ Department of Obstetrics and Gynecology, Midlife Women's Health Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA.
²² Department of Obstetrics and Gynecology, George Washington University, Washington, DC.
²³ Department of Obstetrics and Gynecology, University Clinic Inselspital Bern, Bern, Switzerland.
²⁴ Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Clayton, Victoria, Australia.
²⁵ Department of Obstetrics and Gynaecology, University of Toronto, Toronto, Canada.

PMID: 33973541
DOI: 10.1097/GME.0000000000001788

Abstract

Objective: Genitourinary symptoms, such as vaginal dryness and pain with sex, are commonly experienced by postmenopausal women. Comparing treatments for these genitourinary symptoms are restricted by the use of different outcome measures in clinical trials and the omission of outcomes, which may be relevant to women. The aim of this project was to develop a Core Outcome Set (COS) to be reported in clinical trials of treatments for genitourinary symptoms associated with menopause.

Methods: We performed a systematic review of randomized controlled trials of treatments for genitourinary symptoms associated with menopause and extracted their outcomes. This list was refined and entered into a two-round modified Delphi survey, which was open to clinicians, researchers, and postmenopausal women from November 2019 to March 2020. Outcomes were scored on a nine-point scale from "not important" to "critically important." The final COS was determined following two international consensus meetings.

Results: A total of 26 unique outcomes were included in the Delphi process, which was completed by 227 participants of whom 58% were postmenopausal women, 34% clinicians, and 8% researchers. Predefined thresholds were applied to the Delphi scores to categorize outcomes by importance, which informed the e consensus meetings, attended by 43 participants from 21 countries. The final COS includes eight outcomes: (1) pain with sex, (2) vulvovaginal dryness, (3) vulvovaginal discomfort or irritation, (4) discomfort or pain when urinating, (5) change in most bothersome symptom, (6) distress, bother or interference of genitourinary symptoms, (7) satisfaction with treatment, (8) side effects of treatment.

Conclusion: These eight core outcomes reflect the joint priorities of postmenopausal women, clinicians, and researchers internationally. Standardized collection and reporting of these outcomes in clinical trials will facilitate the comparison of different treatments for genitourinary symptoms, advance clinical practice, and ultimately improve outcomes for symptomatic women.

Plain language summary

Video Summary:http://links.lww.com/MENO/A765 .

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Consensus
Female
Humans
Menopause*
Outcome Assessment, Health Care
Surveys and Questionnaires
Treatment Outcome
Vaginal Diseases* / therapy