Sarah Lensen, Vincent S Paramanandam, Michaela Gabes, Gesina Kann, Theresa Donhauser, Niamh F Waters, Anna D Li, Michelle Peate, Nipuni S Susanto, Lucy E Caughey, Fatema Rangoonwal, Jingbo Liu, Patrick Condron, Panagiotis Anagnostis, David F Archer, Nancy E Avis, Robin J Bell, Janet S Carpenter, Peter Chedraui, Monica Christmas, Melanie Davies, Tim Hillard, Myra S Hunter, Stamatina Iliodromiti, Nicole G Jaff, Unnop Jaisamrarn, Hadine Joffe, Sunila Khandelwal, Ludwig Kiesel, Pauline M Maki, Gita D Mishra, Rossella E Nappi, Nick Panay, Amos Pines, Helen Roberts, Serge Rozenberg, Camilo Rueda, Jan Shifren, James A Simon, Paul Simpson, Muhammad Fidel Ganis Siregar, Petra Stute, Joan Tan Garcia, Amanda J Vincent, Wendy Wolfman, Martha Hickey
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引用次数: 0
Abstract
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.
期刊介绍：
Menopause, published monthly, provides a forum for new research, applied basic science, and clinical guidelines on all aspects of menopause. The scope and usefulness of the journal extend beyond gynecology, encompassing many varied biomedical areas, including internal medicine, family practice, medical subspecialties such as cardiology and geriatrics, epidemiology, pathology, sociology, psychology, anthropology, and pharmacology. This forum is essential to help integrate these areas, highlight needs for future research, and enhance health care.
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