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.
Vincent S. Paramanandam, Sarah Lensen, Michaela Gabes, Gesina Kann, Theresa Donhauser, Niamh F. Watters, 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, and Martha Hickey
Disease Category: Gynaecology
Disease Name: Menopause
Age Range: 15 - 60
Sex: Female
Nature of Intervention: Any
- Clinical experts
- Consumers (patients)
- Researchers
- Recommendations for outcome measures (measurement/how)
- Consensus meeting
- Systematic review
Databases searched were Medline (Ovid), Embase (Ovid), PsycInfo (Ovid), CINAHL Complete, Web of Science Core Collection, PROQOLID, Health and Psychosocial Instruments (Ovid), Leibniz Psychology Open Test Archive, and the COSMIN Database. All searches were initially conducted between September and November 2020 and were
updated in October 2021. Additionally, a secondary search was conducted using the eligible PROM names found during the primary search to identify any studies not identified in the primary search. All results were deduplicated in EndNote (Clarivate. TM, Philadelphia) and uploaded to Covidence (Melbourne, Australia) for screening. We then undertook a consensus process to reach the final recommendations. The process was conducted during the COVID-19 pandemic via online meetings