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Recommended measurement instruments for menopausal vasomotor symptoms: the COMMA (Core Outcomes in Menopause) consortium.
Lensen, Sarah; Paramanandam, Vincent S; Gabes, Michaela; Kann, Gesina; Donhauser, Theresa; Waters, Niamh F; Li, Anna D; Peate, Michelle; Susanto, Nipuni S; Caughey, Lucy E; Rangoonwal, Fatema; Liu, Jingbo; Condron, Patrick; Anagnostis, Panagiotis; 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; Siregar, Muhammad Fidel Ganis; Stute, Petra; Garcia, Joan Tan; Vincent, Amanda J; Wolfman, Wendy; Hickey, Martha.
Afiliación
  • Lensen S; From the Department of Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Australia.
  • Gabes M; University Regensburg, Regensburg, Germany.
  • Kann G; University Regensburg, Regensburg, Germany.
  • Donhauser T; Institute of Social Medicine and Health Systems Research, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany.
  • Waters NF; From the Department of Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Australia.
  • Li AD; From the Department of Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Australia.
  • Peate M; From the Department of Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Australia.
  • Susanto NS; From the Department of Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Australia.
  • Caughey LE; From the Department of Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Australia.
  • Rangoonwal F; From the Department of Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Australia.
  • Liu J; From the Department of Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Australia.
  • Condron P; University Library, The University of Melbourne, Parkville, Australia.
  • Anagnostis P; Unit of Reproductive Endocrinology, 1 Department of Obstetrics and Gynecology, Medical School, Aristotle University of Thessaloniki, Thessaloniki, Greece.
  • Archer DF; Department of Obstetrics and Gynaecology, Eastern Virginia Medical School, Norfolk, VA.
  • Avis NE; Wake Forest University School of Medicine, Winston-Salem, NC.
  • 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.
  • Chedraui P; Escuela de Posgrado en Salud, Universidad Espíritu Santo, Samborondón, Ecuador.
  • Christmas M; Department of Obstetrics and Gynaecology, University of Chicago, Chicago, IL.
  • Davies M; Institute for Women's Health, University College London, UK.
  • 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; Women's Health Research Unit, Wolfson Institute of Population Health, QMUL, London, United Kingdom.
  • Jaff NG; Department of Chemical Pathology, National Health Laboratory Service and University of the Witwatersrand Faculty of Health Sciences, Johannesburg, South Africa.
  • Jaisamrarn U; Center of Excellence in Menopause and Aging Women Health, Department of Obstetrics and Gynecology, 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, Germany.
  • Maki PM; University of Illinois at Chicago, Departments of Psychiatry, Psychology and Obstetrics and Gynecology, Chicago, IL.
  • Mishra GD; Australian Women and Girls' Health Research Centre, School of Public Health, University of Queensland, St Lucia, Australia.
  • Nappi RE; Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Research Center for Reproductive Medicine, Gynecological Endocrinology and Menopause, IRCCS San Matteo Foundation, Pavia, Italy.
  • Panay N; Queen Charlotte's & Chelsea Hospital, Imperial College London, London, UK.
  • Pines A; Tel-Aviv University School of Medicine, Tel-Aviv, Israel.
  • Roberts H; Menopause clinic, Te Toka Tumai, Auckland Hospital, Auckland, New Zealand.
  • Rozenberg S; Department of Ob-Gyn CHU St Pierre, Université Libre de Bruxelles, Brussels, Belgium.
  • Rueda C; University La Sábana, Country Clinic, Bogotá, Colombia.
  • 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.
  • Simpson P; Department of Obstetrics & Gynaecology, Norfolk & Norwich University Hospital NHS Foundation Trust, Norwich, UK.
  • Siregar MFG; Department of Obstetrics and Gynecology, Faculty of Medicine Universitas Sumatera Utara, Sumatera Utara, Indonesia.
  • Stute P; Department of Obstetrics and Gynecology, University Clinic Inselspital, Bern, Switzerland.
  • Garcia JT; Menopause Clinic, Department of Obstetrics & Gynecology, St Lukes Medical Center, Quezon City, Philippines.
  • Vincent AJ; Monash Centre for Health Research and Implementation, Monash University, Clayton, Australia.
  • Wolfman W; Department of Obstetrics and Gynaecology and Mount Sinai Hospital, University of Toronto, Toronto, Canada.
  • Hickey M; From the Department of Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Australia.
Menopause ; 31(7): 582-590, 2024 Jul 01.
Article en En | MEDLINE | ID: mdl-38688464
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Menopausia / Sofocos / Medición de Resultados Informados por el Paciente Límite: Female / Humans Idioma: En Revista: Menopause Asunto de la revista: GINECOLOGIA Año: 2024 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 / Medición de Resultados Informados por el Paciente Límite: Female / Humans Idioma: En Revista: Menopause Asunto de la revista: GINECOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Australia