1. Protocol for development of a core outcome set for menopausal symptoms (COMMA)
- Author
-
Sarah Lensen, Martha Hickey, Robin J. Bell, Monica Christmas, Stamatina Iliodromiti, and Bobae V. Kim
- Subjects
Research design ,medicine.medical_specialty ,Delphi Technique ,General Mathematics ,MEDLINE ,Delphi method ,Psychological intervention ,030209 endocrinology & metabolism ,Original Studies ,law.invention ,COMMA ,Menstruation ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Health care ,Outcome Assessment, Health Care ,medicine ,Humans ,030219 obstetrics & reproductive medicine ,Menopausal symptoms ,Vasomotor symptoms ,business.industry ,Applied Mathematics ,Obstetrics and Gynecology ,Core outcome set ,Clinical research ,Treatment Outcome ,Research Design ,Hot Flashes ,Physical therapy ,Female ,Menopause ,business ,Genitourinary symptoms ,Systematic Reviews as Topic - Abstract
Objective Menopause is the natural cessation of menstruation and may be accompanied by troublesome symptoms including hot flushes and night sweats (vasomotor symptoms) and genitourinary symptoms. Randomized trials evaluating the safety and effectiveness of interventions for these symptoms have reported a wide range of outcomes and used inconsistent measures. This variation precludes comparing and combining data from different trials. To overcome this limitation, we will develop a Core Outcome Set for Menopausal Symptoms. Methods We will systematically review the literature to identify the outcomes reported in the interventional trials for vasomotor and genitourinary symptoms. This list will be entered into a two-round modified Delphi survey to be completed by clinicians, researchers, and consumers (women who have experienced menopause). Participants will score outcomes on a nine-point scale from "not important" to "critically important." Representatives from each stakeholder group will then meet to discuss the results and finalize the Core Outcome Set. Ethics approval was not required as this was considered service evaluation and development. The study is registered with the Core Outcome Measures in Effectiveness Trials Initiative (http://www.comet-initiative.org/studies/details/917). Results An agreed upon set of minimum outcomes and outcome measures will facilitate combining and comparing findings from future trials of treatments for menopausal symptoms. Conclusions This Core Outcome Set will better enable women and clinicians to select effective treatments, improve the quality of trial reporting, reduce research wastage, and improve care for women with troublesome menopausal symptoms. VIDEO SUMMARY:: http://links.lww.com/MENO/A633.
- Published
- 2020