Paramanandam, Vincent S. and Lensen, Sarah and Gabes, Michaela and Kann, Gesina and Donhauser, Theresa and Waters, Niamh F. and Li, Anna D. and Peate, Michelle and Susanto, Nipuni S. and Caughey, Lucy E. and Rangoonwal, Fatema and Liu, Jingbo and Condron, Patrick and Obalowu, Ismaila Aberi and Archer, David F. and Bell, Robin J. and Christmas, Monica and Davies, Melanie and Davis, Susan R. and Giblin, Karen and Iliodromiti, Stamatina and Jaisamrarn, Unnop and Khandelwal, Sunila and Kiesel, Ludwig and Aggarwal, Neelam and Mitchell, Caroline M. and Mishra, Gita D. and Nappi, Rossella E. and Panay, Nick and Roberts, Helen and Rozenberg, Serge and Shifren, Jan and Simon, James A. and Stute, Petra and Vincent, Amanda J. and Wolfman, Wendy and Hickey, Martha (2024) Recommended measurement instruments for genitourinary symptoms associated with menopause: the COMMA (Core outcomes in menopause) consortium. MENOPAUSE-THE JOURNAL OF THE MENOPAUSE SOCIETY, 31 (7). pp. 591-599. ISSN 1072-3714, 1530-0374
Full text not available from this repository. (Request a copy)Abstract
COMMA recommends that the PROMIS-Sexual Function and Satisfaction: Vaginal Discomfort with sexual activity be used to measure "pain with sex," the Day-to-Day Impact of Vaginal Aging Questionnaire to measure "distress, bother or interference of genitourinary symptoms" and that all trials should report adverse events in study participants, which is a requirement of Good Clinical Practice. ObjectiveThe 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.MethodsWe 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.ResultsA 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.ConclusionsSuitable 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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | PROMIS(R) SEXUAL FUNCTION; SATISFACTION MEASURES; SYSTEMATIC REVIEWS; VAGINAL SYMPTOMS; QUESTIONNAIRE; Core Outcome Set; COSMIN; Menopause; Patient-reported outcome measures; PROM; Systematic review |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 07 Aug 2025 05:24 |
| Last Modified: | 07 Aug 2025 05:24 |
| URI: | https://pred.uni-regensburg.de/id/eprint/65663 |
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