Recommended measurement instruments for genitourinary symptoms associated with menopause: the COMMA (Core outcomes in menopause) consortium

Vincent S Paramanandam; Sarah Lensen; Michaela Gabes; Gesina Kann; Theresa Donhauser; Niamh F Waters; Anna D Li; Michelle Peate; Nipuni S Susanto; Lucy E Caughey; Fatema Rangoonwal; Jingbo Liu; Patrick Condron; Ismaila Aberi Obalowu; David F Archer; Robin J Bell; Monica Christmas; Melanie Davies; Susan R Davis; Karen Giblin; Stamatina Iliodromiti; Unnop Jaisamrarn; Sunila Khandelwal; Ludwig Kiesel; Neelam Aggarwal; Caroline M Mitchell; Gita D Mishra; Rossella E Nappi; Nick Panay; Helen Roberts; Serge Rozenberg; Jan Shifren; James A Simon; Petra Stute; Amanda J Vincent; Wendy Wolfman; Martha Hickey

doi:10.1097/GME.0000000000002369

Recommended measurement instruments for genitourinary symptoms associated with menopause: the COMMA (Core outcomes in menopause) consortium

Menopause. 2024 May 14. doi: 10.1097/GME.0000000000002369. Online ahead of print.

Authors

Vincent S Paramanandam¹, Sarah Lensen², Michaela Gabes³, Gesina Kann⁴, Theresa Donhauser³, Niamh F Waters², Anna D Li², Michelle Peate², Nipuni S Susanto², Lucy E Caughey², Fatema Rangoonwal², Jingbo Liu², Patrick Condron⁵, Ismaila Aberi Obalowu⁶, David F Archer⁷, Robin J Bell⁸, Monica Christmas⁹, Melanie Davies¹⁰, Susan R Davis⁸, Karen Giblin¹¹, Stamatina Iliodromiti¹², Unnop Jaisamrarn¹³, Sunila Khandelwal¹⁴, Ludwig Kiesel¹⁵, Neelam Aggarwal¹⁶, Caroline M Mitchell¹⁷, Gita D Mishra¹⁸, Rossella E Nappi¹⁹, Nick Panay²⁰, Helen Roberts²¹, Serge Rozenberg²², Jan Shifren²³, James A Simon²⁴, Petra Stute²⁵, Amanda J Vincent²⁶, Wendy Wolfman²⁷, Martha Hickey²

Affiliations

¹ From the Faculty of Medicine and Health, University of Sydney, Sydney, Australia.
² Department of Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Australia.
³ Institute of Social Medicine and Health Systems Research, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany.
⁴ University Regensburg, Regensburg, Germany.
⁵ University Library, The University of Melbourne, Parkville, Australia.
⁶ General Hospital Ilorin, Ilorin, Kwara State, Nigeria.
⁷ Obstetrics and Gynaecology, Eastern Virginia Medical School, Norfolk, VA.
⁸ Women's Health Research Program, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
⁹ Department of Obstetrics and Gynaecology, University of Chicago, Chicago, IL.
¹⁰ Institute for Women's Health, University College London, UK.
¹¹ Red Hot Mamas North America, Inc., Bridgewater, New Jersey, United States.
¹² Women's Health Research Unit, Wolfson Institute of Population Health, QMUL, London, UK.
¹³ Menopause Research Group, Department of Obstetrics and Gynaecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
¹⁴ Department of Obstetrics and Gynaecology, Fortis Escort Hospital, Jaipur, India.
¹⁵ Department of Gynaecology and Obstetrics, University of Muenster, Muenster, Germany.
¹⁶ Department of Gynaecology and Obstetrics, PostGraduate Institute of Medical Education & Research, Chandigarh, India.
¹⁷ Vincent Center for Reproductive Biology, Massachusetts General Hospital, Boston, MA.
¹⁸ Australian Women and Girls' Health Research Centre, School of Public Health, University of Queensland, St Lucia, Australia.
¹⁹ Research Center for Reproductive Medicine, Gynecological Endocrinology and Menopause, IRCCS San Matteo Foundation, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy.
²⁰ Queen Charlotte's & Chelsea and Chelsea and Westminster Hospitals, Imperial College London, London, UK.
²¹ Auckland District Health Board, Auckland, New Zealand.
²² Department of Ob-Gyn CHU St Pierre, Université Libre de Bruxelles, Brussels, Belgium.
²³ Midlife Women's Health Center, Department of Obstetrics and Gynecology, Massachusetts General Hospital, Harvard Medical School, Boston, MA.
²⁴ Department of Obstetrics and Gynecology, George Washington University, Washington, DC.
²⁵ Department of Obstetrics and Gynecology, University Clinic Inselspital, Bern, Switzerland.
²⁶ Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Clayton, Australia.
²⁷ Department of Obstetrics and Gynaecology, University of Toronto, Toronto, Canada.

PMID: 38743907
DOI: 10.1097/GME.0000000000002369

Abstract

Objective: The aim of the study is to identify appropriate definitions and patient-reported outcome measures (PROMs) for each of the eight core outcomes previously selected for genitourinary symptoms associated with menopause: pain with sex, vulvovaginal dryness, vulvovaginal discomfort or irritation, discomfort or pain when urinating, change in most bothersome symptom, distress, bother or interference of genitourinary symptoms, satisfaction with treatment, and side effects.

Methods: We conducted a systematic review to identify possible definitions and PROMs, including their measurement properties. Identified definitions and relevant PROMs with acceptable measurement properties were entered into an international consensus process involving 28 participants from 10 countries to achieve final recommendations for each core outcome.

Results: A total of 87 publications reporting on 34 PROMs were identified from 21,207 publications screened. Of these 34 PROMs, 29 were not considered to sufficiently map onto the core outcomes, and 26 of these also had insufficient measurement properties. Therefore, only five PROMs corresponding to two core outcomes were considered for recommendation. We recommend the PROMIS Scale v2.0 - Sexual Function and Satisfaction: Vaginal Discomfort with Sexual Activity to measure the outcome of "pain with sexual activity" and the Day-to-Day Impact of Vaginal Aging (DIVA) Questionnaire to measure "distress, bother or interference" from genitourinary symptoms. Six definitions of "side effects" were identified and considered. We recommend that all trials report adverse events in study participants, which is a requirement of Good Clinical Practice.

Conclusions: Suitable PROMs and definitions were identified to measure three of eight core outcomes. Because of the lack of existing measures, which align with the core outcomes and have evidence of high-quality measurement properties, future work will focus on developing or validating PROMs for the remaining five core outcomes.