Summary
Hot flushes and night sweats (vasomotor symptoms, VMS) are one of the most common symptoms of menopause and a leading patient priority for treatment [1]. New therapies are emerging, but comparing the safety and effectiveness of treatments for VMS is limited by the use of different outcome measures between studies. Further, it is uncertain which outcomes are most important to symptomatic women. To address this limitation, an international consensus group led by Professor Martha Hickey [2] have developed a Core Outcome Set (COS) for the measurement of VMS. These are a minimum dataset to be collected in clinical trials for VMS. To develop this dataset, the authors systematically reviewed all primary outcome measures used in randomized controlled trials of treatments for VMS [3]. Using a standardized process including a two round Delphi survey and consensus meetings of clinicians, researchers, and women with lived experience of menopause (n=277), the COMMA consortium identified six core outcomes: 1) frequency of VMS, 2) severity of VMS, 3) distress, bother or interference caused by VMS, 4) impact on sleep, 5) satisfaction with treatment, and 6) side-effects of treatment. The consensus meetings were attended by 56 participants from 28 countries. The authors conclude that the implementation of this COS will better enable clinical trials for VMS to measure outcomes that accurately reflect the joint priorities of postmenopausal women, clinicians and researchers. The COS will also standardize outcome reporting, and facilitate combining and comparing results from different studies, and ultimately improve outcomes for women with bothersome VMS.
Commentary
The development of COSs is an emerging initiative across many health domains. In essence, the process systematically identifies outcomes used in previous clinical trials for a particular condition (in this case, VMS), recruits participants from the key stakeholder groups internationally and then uses the Delphi process to achieve global consensus about the outcomes of most importance for these stakeholders: in this case, clinicians, researchers and women with lived experience of menopause. COMMA identified six core outcomes to be measured in clinical trials of treatments for VMS. This includes outcomes commonly measured in previous trials such as the frequency and severity of VMS, including those commonly measured in clinical trials. In addition, the international group considered that the impact (distress, bother or interference) of VMS and the impact on sleep should be measured. Patient satisfaction and the side-effects of treatment were included in the COS. A systematic review by the COMMA team found 49 different primary outcomes in previous randomized controlled trials of treatments for VMS. By limiting and harmonizing these outcome measures using a standardized and transparent process, COMMA represents a major step forward in menopause research. Strong representation from women with lived experience of menopause (85% of participants) means that the COS effectively represents patient priority areas. Holding consensus meetings by Zoom across time zones (rather than in-person), increased participation from low and middle income countries [2]. The global COMMA team have also produced a COS for clinical trials of treatments for genitourinary symptoms associated with menopause [4]. The principal aim of COMMA is to harmonize research in menopause worldwide by standardizing the outcomes used in clinical trials, ensuring that these reflect the priorities of those designing and delivering research and those who are seeking effective treatments for their symptoms [2]. Implementation of this COS will improve consistency of outcome reportings across menopause research, reduce the number of uninformative trials and facilitate the findings from different trials to be combined. We look forward to further advice from the consortium about the optimal tools to measure these outcomes and to greater standardization of menopause research in the future.
Prof. Martha Hickey, BA, MSc, MBChB, FRCOG, FRANZCOG, MD
Deputy Head, Department of Obstetrics and Gynaecology, The University of Melbourne, Melbourne, and Co-Head of the Gynaecology Research Centre, Royal Women’s Hospital, Victoria, Australia
References
- Carpenter JS, Woods NF, Otte JL, et al. MsFLASH participants’ priorities for alleviating menopausal symptoms. Climacteric. 2015;18(6):859-66.
https://pubmed.ncbi.nlm.nih.gov/26517583/ - Lensen S, Archer D, Bell RJ, et al. A core outcome set for vasomotor symptoms associated with menopause: the COMMA (Core Outcomes in Menopause) global initiative. Menopause. 2021 Apr 26. doi: 10.1097/GME.0000000000001787.
https://pubmed.ncbi.nlm.nih.gov/33906204/ - Iliodromiti S, Wang W, Lumsden MA, Hunter MS, Bell R, Mishra G, Hickey M. Variation in menopausal vasomotor symptoms outcomes in clinical trials: a systematic review. BJOG. 2020;127(3):320-333.
https://pubmed.ncbi.nlm.nih.gov/31621155/ - Lensen S, Bell RJ, Carpenter JS, et al. A core outcome set for genitourinary symptoms associated with menopause: the COMMA (Core Outcomes in Menopause) global initiative. Menopause. 2021 May 10. doi: 10.1097/GME.0000000000001788.
https://pubmed.ncbi.nlm.nih.gov/33973541/
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