دورية أكاديمية
Recommended measurement instruments for genitourinary symptoms associated with menopause: the COMMA (Core outcomes in menopause) consortium.
| العنوان: | Recommended measurement instruments for genitourinary symptoms associated with menopause: the COMMA (Core outcomes in menopause) consortium. |
|---|---|
| المؤلفون: | Paramanandam VS; From the Faculty of Medicine and Health, University of Sydney, Sydney, Australia., Lensen S; Department of Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Australia., Gabes M; Institute of Social Medicine and Health Systems Research, Otto-von-Guericke-University Magdeburg, Magdeburg, 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; Department of Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Australia., Li AD; Department of Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Australia., Peate M; Department of Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Australia., Susanto NS; Department of Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Australia., Caughey LE; Department of Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Australia., Rangoonwal F; Department of Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Australia., Liu J; Department of Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Australia., Condron P; University Library, The University of Melbourne, Parkville, Australia., Obalowu IA; General Hospital Ilorin, Ilorin, Kwara State, Nigeria., Archer DF; 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., Christmas M; Department of Obstetrics and Gynaecology, University of Chicago, Chicago, IL., Davies M; Institute for Women's Health, University College London, UK., 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., Bridgewater, New Jersey, United States., Iliodromiti S; Women's Health Research Unit, Wolfson Institute of Population Health, QMUL, London, UK., Jaisamrarn U; Menopause Research Group, Department of Obstetrics and Gynaecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand., Khandelwal S; Department of Obstetrics and Gynaecology, Fortis Escort Hospital, Jaipur, India., Kiesel L; Department of Gynaecology and Obstetrics, University of Muenster, Muenster, Germany., Aggarwal N; Department of Gynaecology and Obstetrics, PostGraduate Institute of Medical Education & Research, Chandigarh, India., Mitchell CM; Vincent Center for Reproductive Biology, Massachusetts General Hospital, Boston, MA., Mishra GD; Australian Women and Girls' Health Research Centre, School of Public Health, University of Queensland, St Lucia, Australia., 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 & Chelsea and Chelsea and Westminster Hospitals, Imperial College London, London, UK., Roberts H; Auckland District Health Board, Auckland, New Zealand., Rozenberg S; Department of Ob-Gyn CHU St Pierre, Université Libre de Bruxelles, Brussels, Belgium., 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., Stute P; Department of Obstetrics and Gynecology, University Clinic Inselspital, Bern, Switzerland., Vincent AJ; Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Clayton, Australia., Wolfman W; Department of Obstetrics and Gynaecology, University of Toronto, Toronto, Canada., Hickey M; Department of Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Australia. |
| المصدر: | Menopause (New York, N.Y.) [Menopause] 2024 Jul 01; Vol. 31 (7), pp. 591-599. Date of Electronic Publication: 2024 May 14. |
| نوع المنشور: | Journal Article; Systematic Review |
| اللغة: | English |
| بيانات الدورية: | Publisher: Lippincott-Raven Publishers Country of Publication: United States NLM ID: 9433353 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1530-0374 (Electronic) Linking ISSN: 10723714 NLM ISO Abbreviation: Menopause Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Hagerstown, MD : Lippincott-Raven Publishers Original Publication: New York, NY : Raven Press, c1994- |
| مواضيع طبية MeSH: | Menopause*/physiology , Patient Reported Outcome Measures*, Humans ; Female ; Female Urogenital Diseases/therapy ; Quality of Life ; Sexual Dysfunction, Physiological ; Surveys and Questionnaires/standards ; Middle Aged |
| مستخلص: | Objective: The aim of the study is to identify appropriate definitions and patient-reported outcome measures (PROMs) for each of the eight core outcomes previously selected for genitourinary symptoms associated with menopause: pain with sex, vulvovaginal dryness, vulvovaginal discomfort or irritation, discomfort or pain when urinating, change in most bothersome symptom, distress, bother or interference of genitourinary symptoms, satisfaction with treatment, and side effects. Methods: We conducted a systematic review to identify possible definitions and PROMs, including their measurement properties. Identified definitions and relevant PROMs with acceptable measurement properties were entered into an international consensus process involving 28 participants from 10 countries to achieve final recommendations for each core outcome. Results: A total of 87 publications reporting on 34 PROMs were identified from 21,207 publications screened. Of these 34 PROMs, 29 were not considered to sufficiently map onto the core outcomes, and 26 of these also had insufficient measurement properties. Therefore, only five PROMs corresponding to two core outcomes were considered for recommendation. We recommend the PROMIS Scale v2.0 - Sexual Function and Satisfaction: Vaginal Discomfort with Sexual Activity to measure the outcome of "pain with sexual activity" and the Day-to-Day Impact of Vaginal Aging (DIVA) Questionnaire to measure "distress, bother or interference" from genitourinary symptoms. Six definitions of "side effects" were identified and considered. We recommend that all trials report adverse events in study participants, which is a requirement of Good Clinical Practice. Conclusions: Suitable PROMs and definitions were identified to measure three of eight core outcomes. Because of the lack of existing measures, which align with the core outcomes and have evidence of high-quality measurement properties, future work will focus on developing or validating PROMs for the remaining five core outcomes. Competing Interests: Financial disclosure/conflicts of interest: M.G. received past funding from Effik SA. M.P. received institutional funding from University of Melbourne (Internal Grant Schemes), Royal Women's Hospital (Internal grant scheme), and Cancer Council NSW Project Grant RG 21-06, Centre for Research Excellence in Women's Health in Reproductive Life (CREWHiRL) Seed Funding and Project Support Grant, NHMRC (APP1163202), and Royal Children's Hospital Foundation. She received past funding from FertilityIQ webinar honorarium. She has received fee registration fees as an invited speaker by the Pacific Society of Reproductive Medicine 2023 Conference and had subsidized flights and accommodations as an invited speaker for the European Society of Human Reproduction and Embryology 2022 Conference. She was also given free registration as an invited speaker for the Annual Scientific Meeting of Breast Cancer Trials 2021. D.A. has consulted for Evestra, Exeltis, Lupin, Mithra, ObsEva, and TherapeuticsMD, received industry support for research from AbbVie, Mithra, Myovant, and ObsEva, and has stock holdings in Agile Therapeutics and InnovaGyn, Inc. R.B. was named CI on two grants to Monash University, one from the National Health and Medical Research Council of Australia and one from the Medical Research Future Fund for work not related to the current publication. M.C. has been paid for developing and delivering educational presentations for AllianceChicago, wrote a White Paper on GSM for Materna (no financial reimbursement), and is a member of The Menopause Society Board of Trustees, FDA BRUDAC Committee, and Grand Rounds Presenter University of Indians. S.R.D. reports honoraria from BesinsHealthcare, Mayne Pharma, Health Ed, BioSyent, Lawley Pharmaceuticals, Abbott Laboratories, and Que Oncology. She has served on advisory boards for Mayne Pharm, Astellas Pharmaceuticals, Theramex, Abbott Laboratories, and Gedeon Richterand and has been an institutional investigator for QueOncology and Ovoca Bio. L.K. has lectured and/or acted in an advisory capacity for Gedeon Richter, Dr. KADE Besins and Mithra. C.M.M. has served as a consultant for Scynexis and Ferring Pharmaceuticals, receives research funding from Scynexis, and receives Royalties from UpToDate. R.E.N. has ongoing relationships with Abbott, Astellas, Bayer HealthCare AG, Besins Healthcare, Exeltis, Fidia, Gedeon Richter, HRA Pharma, Merck Healthcare, Novo Nordisk, Shionogi Limited, Theramex, and Viatris. N.P. has lectured and/or acted in an advisory capacity for Abbott, Bayer, Besins, Gedeon Richter, Kora, Lawley, Mithra, Mylan, Novo Nordisk, Roche Diagnostics, SeCur, Shionogi, Theramex, and Viatris. S.R. has lectured and/or acted in an advisory capacity or conducted studies for Abbott, Bayer, Gedeon Richter, Mylan, Amgen, UCB, Theramex, and Viatris. J.S. receives grant/research support from AbbVie, Inc., Bayer Healthcare LLC., Dare´ Bioscience, Ipsen, Mylan/Viatris Inc., Myovant Sciences, and Sebela Pharmaceuticals Inc. He acts as a consultant is on advisory boards for Bayer HealthCare Pharmaceuticals Inc., Besins Healthcare, California Institute of Integral Studies (CIIS), Dare´ Bioscience, Femasys Inc., Khyria, Madorra Pty Ltd., Mayne Pharma, Inc., and Vella Bioscience Inc. He serves on speaker's bureaus for Astellas Pharma, Inc., Mayne Pharma, Inc., Myovant Sciences, Inc., Pfizer Inc., Pharmavite LLC., and Scynexis Inc. He is a stockholder (direct purchase) of Sermonix Pharmaceuticals. P.S. has received fees for giving educational presentations, and participating in advisory boards and conducting research by Besins Healthcare, Astellas, Mylan, Labatec, Exeltis, Effik, Theramex, and Gedeon-Richter. A.J.V. has received fees for presentations and participation in an advisory board from Besins and Theramex. W.W. has received institutional support with an unrestricted grant from Pfizer and sits on the advisory boards of Pfizer, Lupin, and Biosyent. She has received fees for educational presentations for Lupin, Astellas, Bayer and Pfizer, and Biosyent. She is currently president of the Canadian Menopause Society and a Board Member of the International Menopause Society. M.H. has received funding from Madorra for a study of a device to manage GU symptoms. All other authors report no conflicts of interest. (Copyright © 2024 by The Menopause Society.) |
| References: | Lethaby A, Ayeleke RO, Roberts H. Local oestrogen for vaginal atrophy in postmenopausal women. Cochrane Database Syst Rev 2016;2016:CD001500. doi: 10.1002/14651858.CD001500.pub3. (PMID: 10.1002/14651858.CD001500.pub3) Christmas MM, Song B, Bell RJ, et al. Variation in outcome reporting and measurement tools in clinical trials of treatments for genitourinary symptoms in peri- and postmenopausal women: a systematic review. Menopause 2020;27:1070–1080. doi: 10.1097/GME.0000000000001570. (PMID: 10.1097/GME.0000000000001570) Kim BV, Iliodromiti S, Christmas M, et al. Protocol for development of a Core Outcome set for Menopausal symptoms (COMMA). Menopause 2020;27:1371–1375. doi: 10.1097/GME.0000000000001632. (PMID: 10.1097/GME.0000000000001632) 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;28:852–858. doi: 10.1097/GME.0000000000001787. (PMID: 10.1097/GME.0000000000001787) 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;28:859–866. doi: 10.1097/GME.0000000000001788. (PMID: 10.1097/GME.0000000000001788) Prinsen CA. Guideline for selecting outcome measurement instruments for outcomes included in a Core Outcome Set vol. 17. 2016. Available at: https://www.cosmin.nl/wp-content/uploads/COSMIN-guideline-selecting-outcome-measurement-COS.pdf . U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research; U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research; U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes 2006;4:79. doi: 10.1186/1477-7525-4-79. (PMID: 10.1186/1477-7525-4-79) Terwee CB, Prinsen CA, Chiarotto A, et al. COSMIN methodology for assessing the content validity of PROMs – user manual . COSMIN; 2018. Available at: http://www.cosmin.nl . Accessed July 23, 2019. Prinsen CAC, Mokkink LB, Bouter LM, et al. COSMIN guideline for systematic reviews of patient-reported outcome measures. Qual Life Res 2018;27:1147–1157. doi: 10.1007/s11136-018-1798-3. (PMID: 10.1007/s11136-018-1798-3) Mokkink LB, de Vet HCW, Prinsen CAC, et al. COSMIN Risk of Bias checklist for systematic reviews of patient-reported outcome measures. Qual Life Res 2018;27:1171–1179. doi: 10.1007/s11136-017-1765-4. (PMID: 10.1007/s11136-017-1765-4) COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN). Available at: https://www.cosmin.nl/tools/pubmed-search-filters/ . Accessed July 6, 2022. Prinsen CAC, Vohra S, Rose MR, et al. How to select outcome measurement instruments for outcomes included in a "Core Outcome Set" - a practical guideline. Trials 2016;17:449. doi: 10.1186/s13063-016-1555-2. (PMID: 10.1186/s13063-016-1555-2) Terwee CB, Bot SDM, de Boer MR, et al. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol 2007;60:34–42. doi: 10.1016/j.jclinepi.2006.03.012. (PMID: 10.1016/j.jclinepi.2006.03.012) Flynn KE, Carter J, Lin L, et al. Assessment of vulvar discomfort with sexual activity among women in the United States. Am J Obstet Gynecol 2017;216:391.e1–391.e8. doi: 10.1016/j.ajog.2016.12.006. (PMID: 10.1016/j.ajog.2016.12.006) Weinfurt KP, Lin L, Bruner DW, et al. Development and Initial Validation of the PROMIS(®) Sexual Function and Satisfaction Measures Version 2.0. J Sex Med 2015;12:1961–1974. doi: 10.1111/jsm.12966. (PMID: 10.1111/jsm.12966) Flynn KE, Lin L, Cyranowski JM, et al. Development of the NIH PROMIS ® Sexual Function and Satisfaction measures in patients with cancer. J Sex Med 2013;10(Suppl 1):43–52. doi: 10.1111/j.1743-6109.2012.02995.x. (PMID: 10.1111/j.1743-6109.2012.02995.x) Huang AJ, Gregorich SE, Kuppermann M, et al. Day-to-Day Impact of Vaginal Aging Questionnaire: a multidimensional measure of the impact of vaginal symptoms on functioning and well-being in postmenopausal women. Menopause 2015;22:144–154. doi: 10.1097/GME.0000000000000281. (PMID: 10.1097/GME.0000000000000281) Erekson EA, Yip SO, Wedderburn TS, et al. The Vulvovaginal Symptoms Questionnaire: a questionnaire for measuring vulvovaginal symptoms in postmenopausal women. Menopause 2013;20:973–979. doi: 10.1097/GME.0b013e318282600b. (PMID: 10.1097/GME.0b013e318282600b) Haywood K, Potter R, Froud R, et al. Core outcome set for preventive intervention trials in chronic and episodic migraine (COSMIG): an international, consensus-derived and multistakeholder initiative. BMJ Open 2021;11:e043242. doi: 10.1136/bmjopen-2020-043242. (PMID: 10.1136/bmjopen-2020-043242) Shifren JL, Zincavage R, Cho EL, et al. Women's experience of vulvovaginal symptoms associated with menopause. Menopause 2019;26:341–349. doi: 10.1097/GME.0000000000001275. (PMID: 10.1097/GME.0000000000001275) Lund KS, Siersma VD, Christensen KB, Waldorff FB, Brodersen J. Measuring bothersome menopausal symptoms: development and validation of the MenoScores questionnaire. Health Qual Life Outcomes 2018;16:97. doi: 10.1186/s12955-018-0927-6. (PMID: 10.1186/s12955-018-0927-6) Mercier J, Morin M, Reichetzer B, Lemieux MC, Khalife S, Dumoulin C. Genitourinary syndrome of menopause symptom severity and impact outcome measures: are they reliable and correlated? Menopause 2018;26:659–664. doi: 10.1097/GME.0000000000001287. (PMID: 10.1097/GME.0000000000001287) Paramanandam VS, Lee MJ, Kilbreath SL, Dylke ES. Self-reported questionnaires for lymphoedema: a systematic review of measurement properties using COSMIN framework. Acta Oncol 2021;60:379–391. doi: 10.1080/0284186X.2020.1862422. (PMID: 10.1080/0284186X.2020.1862422) |
| تواريخ الأحداث: | Date Created: 20240514 Date Completed: 20240628 Latest Revision: 20240703 |
| رمز التحديث: | 20240704 |
| DOI: | 10.1097/GME.0000000000002369 |
| PMID: | 38743907 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1530-0374 |
|---|---|
| DOI: | 10.1097/GME.0000000000002369 |