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A core outcome set for vasomotor symptoms associated with menopause: the COMMA (Core Outcomes in Menopause) global initiative.
Lensen, Sarah; Archer, David; Bell, Robin J; Carpenter, Janet S; Christmas, Monica; Davis, Susan R; Giblin, Karen; Goldstein, Steven R; Hillard, Tim; Hunter, Myra S; Iliodromiti, Stamatina; Jaisamrarn, Unnop; Joffe, Hadine; Khandelwal, Sunila; Kiesel, Ludwig; Kim, Bobae V; Lambalk, Cornelis B; Lumsden, Mary Ann; Maki, Pauline M; Nappi, Rossella E; Panay, Nick; Roberts, Helen; Shifren, Jan; Simon, James A; Vincent, Amanda; Wolfman, Wendy; Hickey, Martha.
Afiliación
  • Lensen S; Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Australia.
  • Archer D; Obstetrics and Gynaecology, Eastern Virginia Medical School, Norfolk, VA.
  • Bell RJ; Women's Health Research Program, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
  • Carpenter JS; School of Nursing, Indiana University, Indianapolis, IN.
  • Christmas M; Department of Obstetrics and Gynaecology, University of Chicago, Chicago, IL.
  • Davis SR; Women's Health Research Program, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
  • Giblin K; Red Hot Mamas North America, Inc, Town of Ridgefield, CT.
  • Goldstein SR; Obstetrics and Gynecology, New York University School of Medicine, New York, NY.
  • Hillard T; Department of Obstetrics and Gynaecology, University Hospitals Dorset NHS Trust, Poole, Dorset, UK.
  • Hunter MS; Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
  • Iliodromiti S; Centre for Women's Health, Institute of Population Health Sciences, Queen Mary University London, London, UK.
  • Jaisamrarn U; Department of Obstetrics and Gynaecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
  • Joffe H; Connors Center for Women's Health and Gender Biology and the Department of Psychiatry, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
  • Khandelwal S; Department of Obstetrics and Gynaecology, Fortis Escort Hospital, Jaipur, India.
  • Kiesel L; Department of Gynaecology and Obstetrics, University of Muenster, Muenster, Germany.
  • Kim BV; Adelaide Medical School, Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, Australia.
  • Lambalk CB; Amsterdam Reproduction and Development, Center for Reproductive Medicine, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, The Netherlands.
  • Lumsden MA; Department of Reproductive and Maternal medicine, School of Medicine, University of Glasgow, Glasgow, UK.
  • Maki PM; University of Illinois at Chicago, Departments of Psychiatry, Psychology and Obstetrics and Gynecology, Chicago, IL.
  • Nappi RE; Research Center for Reproductive Medicine, Gynecological Endocrinology and Menopause, IRCCS San Matteo Foundation, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy.
  • Panay N; Queen Charlotte's and Chelsea and Chelsea and Westminster Hospitals, Imperial College London, London, UK.
  • Roberts H; Auckland District Health Board, Auckland, New Zealand.
  • Shifren J; Midlife Women's Health Center, Department of Obstetrics and Gynecology, Massachusetts General Hospital, Harvard Medical School, Boston, MA.
  • Simon JA; Department of Obstetrics and Gynecology, George Washington University, Washington, DC.
  • Vincent A; Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Clayton, Victoria, Australia.
  • Wolfman W; Department of Obstetrics and Gynaecology, University of Toronto, Toronto, Canada.
  • Hickey M; Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Australia.
Menopause ; 28(8): 852-858, 2021 04 26.
Article en En | MEDLINE | ID: mdl-33906204
ABSTRACT

OBJECTIVE:

Vasomotor symptoms (VMS) (hot flashes and night sweats) affect most women over the menopause transition. Comparing the safety and effectiveness of treatments for vasomotor symptoms is limited by the use of inconsistent outcome measures, and uncertainty as to which outcomes are most important to symptomatic women. To address this, we have developed a Core Outcome Set (COS) for use in clinical trials of treatments for VMS.

METHODS:

We systematically reviewed the primary outcomes measured in randomized controlled trials of treatments for VMS. These were refined and entered into a two-round modified Delphi survey completed by clinicians, researchers, and postmenopausal women between November 2019 and March 2020. Outcomes were scored on a nine-point scale from "not important" to "critically important." Two international consensus meetings were held to finalize the COS.

RESULTS:

Based on the systematic review, 13 separate outcomes were included in the Delphi process. This was completed by 227 participants of whom 58% were postmenopausal women, 34% clinicians, and 8% researchers. Predefined thresholds were applied to categorize importance scores obtained during Round 2 of the Delphi survey. These informed discussions at the consensus meetings which were attended by 56 participants from 28 countries. The final COS includes six

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.

CONCLUSION:

Implementation of this COS will better enable research studies to accurately reflect the joint priorities of postmenopausal women, clinicians and researchers, standardize outcome reporting, and facilitate combining and comparing results from different studies, and ultimately improve outcomes for women with bothersome VMS.
Video

Summary:

http//links.lww.com/MENO/A763 .
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Menopausia / Sofocos Tipo de estudio: Clinical_trials / Diagnostic_studies / Guideline / Risk_factors_studies / Systematic_reviews Límite: Female / Humans Idioma: En Revista: Menopause Asunto de la revista: GINECOLOGIA Año: 2021 Tipo del documento: Article País de afiliación: Australia
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Menopausia / Sofocos Tipo de estudio: Clinical_trials / Diagnostic_studies / Guideline / Risk_factors_studies / Systematic_reviews Límite: Female / Humans Idioma: En Revista: Menopause Asunto de la revista: GINECOLOGIA Año: 2021 Tipo del documento: Article País de afiliación: Australia