Objective
The 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.
Methods
A 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.
Results
A 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.
Conclusions
We 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.
Lensen, Sarah, Paramanandam, Vincent S. Gabes, Michaela Kann, Gesina Donhauser, Theresa Waters, Niamh Li, Anna Peate, Michelle Susanto, Nipuni S. B Caughey, Lucy E. B Behav Rangoonwal, Fatema Liu, Jingbo Condron, Patrick Archer, David F. Avis, Nancy E. Bell, Robin J. Carpenter, Janet S. Chedraui, Peter Christmas, Monica Davies, Melanie Hillard, Tim Hunter, Myra S. Iliodromiti, Stamatina Jaff, Nicole G. Jaisamrarn, Unnop Joffe, Hadine Khandelwal, Sunila Kiesel, Ludwig Maki, Pauline M. Mishra, Gita D. Nappi, Rossella E. Panay, Nick Pines, Amos Roberts, Helen Rozenberg, Serge Rueda, Camilo Shifren, Jan Simon, James A. Simpson, Paul MA(Cantab), Siregar, Muhammad Fidel Ganis Stute, Petra Garcia, Joan Tan Vincent, Amanda J. Wolfman, Wendy Hickey, Martha
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
We designed a comprehensive search strategy to identify all possible PROMs, using terms and synonyms relating to menopause combined with the COSMIN filter and a COSMIN-recommended PROMs filter.9 We searched 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. The primary search was performed between September and November 2020 and updated in October 2021. We performed a secondary search for studies relating to PROMs identified as potentially eligible during the primary search. Results were imported into EndNote (Clarivate. TM, Philadelphia, PA) to be deduplicated and then uploaded to Covidence (Melbourne, Australia) for screening. Consensus meetings were used to discuss the potential PROMs and reach the final recommendations.