Lensen, Sarah and Paramanandam, Vincent S. 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 Anagnostis, Panagiotis and Archer, David F. and Avis, Nancy E. and Bell, Robin J. and Carpenter, Janet S. and Chedraui, Peter and Christmas, Monica and Davies, Melanie and Hillard, Tim and Hunter, Myra S. and Iliodromiti, Stamatina and Jaff, Nicole G. and Jaisamrarn, Unnop and Joffe, Hadine and Khandelwal, Sunila and Kiesel, Ludwig and Maki, Pauline M. and Mishra, Gita D. and Nappi, Rossella E. and Panay, Nick and Pines, Amos and Roberts, Helen and Rozenberg, Serge and Rueda, Camilo and Shifren, Jan and Simon, James A. and Simpson, Paul and Siregar, Muhammad Fidel Ganis and Stute, Petra and Garcia, Joan Tan and Vincent, Amanda J. and Wolfman, Wendy and Hickey, Martha (2024) Recommended measurement instruments for menopausal vasomotor symptoms: the COMMA (Core Outcomes in Menopause) consortium. MENOPAUSE-THE JOURNAL OF THE MENOPAUSE SOCIETY, 31 (7). pp. 582-590. ISSN 1072-3714, 1530-0374
Full text not available from this repository. (Request a copy)Abstract
The COMMA (Core Outcomes in Menopause) recommends that the Hot Flash Related Daily Interference Scale be used to measure distress, bother, or interference of vasomotor symptoms and to capture impact on sleep. Additionally, 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 suitable definitions and patient-reported outcome measures (PROMs) to assess each of the six core outcomes previously identified through the COMMA (Core Outcomes in Menopause) global consensus process relating to vasomotor symptoms: frequency, severity, distress/bother/interference, impact on sleep, satisfaction with treatment, and side effects.MethodsA systematic review was conducted to identify relevant definitions for the outcome of side-effects and PROMs with acceptable measurement properties for the remaining five core outcomes. The consensus process, involving 36 participants from 16 countries, was conducted to review definitions and PROMs and make final recommendations for the measurement of each core outcome.ResultsA total of 21,207 publications were screened from which 119 reporting on 40 PROMs were identified. Of these 40 PROMs, 36 either did not adequately map onto the core outcomes or lacked sufficient measurement properties. Therefore, only four PROMs corresponding to two of the six core outcomes were considered for recommendation. We recommend the Hot Flash Related Daily Interference Scale to measure the domain of distress, bother, or interference of vasomotor symptoms and to capture impact on sleep (one item in the Hot Flash Related Daily Interference Scale captures interference with sleep). Six definitions of "side effects" were identified and considered. We recommend that all trials report adverse events, which is a requirement of Good Clinical Practice.ConclusionsWe identified suitable definitions and PROMs for only three of the six core outcomes. No suitable PROMs were found for the remaining three outcomes (frequency and severity of vasomotor symptoms and satisfaction with treatment). Future studies should develop and validate PROMs for these outcomes.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | OF-LIFE QUESTIONNAIRE; PSYCHOMETRIC PROPERTIES; SYSTEMATIC REVIEWS; CLIMACTERIC SCALE; VALIDITY; VALIDATION; VERSION; IMPACT; WOMEN; Core outcome set; COSMIN; Menopause; Patient-reported outcome measure (PROM); Systematic review; Vasomotor |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Psychiatrie und Psychotherapie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 24 Jul 2025 09:49 |
| Last Modified: | 24 Jul 2025 09:49 |
| URI: | https://pred.uni-regensburg.de/id/eprint/65718 |
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