Recommended measurement instruments for genitourinary symptoms associated with menopause: the COMMA (Core outcomes in menopause) consortium-Reference-Cited by-同舟云学术

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

Published:2024-05-14 Issue: Volume: Page:
ISSN:1530-0374
Container-title:Menopause
language:en
Short-container-title:Menopause

Author:

Paramanandam Vincent S.¹,Lensen Sarah²,Gabes Michaela³,Kann Gesina⁴,Donhauser Theresa³,Waters Niamh F.²,Li Anna D.²,Peate Michelle²,Susanto Nipuni S.²,Caughey Lucy E.²,Rangoonwal Fatema²,Liu Jingbo²,Condron Patrick⁵,Obalowu Ismaila Aberi⁶,Archer David F.⁷,Bell Robin J.⁸,Christmas Monica⁹,Davies Melanie¹⁰,Davis Susan R.⁸,Giblin Karen¹¹,Iliodromiti Stamatina¹²,Jaisamrarn Unnop¹³,Khandelwal Sunila¹⁴,Kiesel Ludwig¹⁵,Aggarwal Neelam¹⁶,Mitchell Caroline M.¹⁷,Mishra Gita D.¹⁸,Nappi Rossella E.¹⁹,Panay Nick²⁰,Roberts Helen²¹,Rozenberg Serge²²,Shifren Jan²³,Simon James A.²⁴,Stute Petra²⁵,Vincent Amanda J.²⁶,Wolfman Wendy²⁷,Hickey Martha²

Affiliation:

1. 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.

Abstract

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.

Publisher

Ovid Technologies (Wolters Kluwer Health)

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