Vincent S Paramanandam, Sarah Lensen, 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, Ismaila Aberi Obalowu, David F Archer, Robin J Bell, Monica Christmas, Melanie Davies, Susan R Davis, Karen Giblin, Stamatina Iliodromiti, Unnop Jaisamrarn, Sunila Khandelwal, Ludwig Kiesel, Neelam Aggarwal, Caroline M Mitchell, Gita D Mishra, Rossella E Nappi, Nick Panay, Helen Roberts, Serge Rozenberg, Jan Shifren, James A Simon, Petra Stute, Amanda J Vincent, Wendy Wolfman, Martha Hickey
{"title":"与更年期相关的泌尿生殖系统症状的推荐测量工具:COMMA(更年期核心结果)联盟。","authors":"Vincent S Paramanandam, Sarah Lensen, 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, Ismaila Aberi Obalowu, David F Archer, Robin J Bell, Monica Christmas, Melanie Davies, Susan R Davis, Karen Giblin, Stamatina Iliodromiti, Unnop Jaisamrarn, Sunila Khandelwal, Ludwig Kiesel, Neelam Aggarwal, Caroline M Mitchell, Gita D Mishra, Rossella E Nappi, Nick Panay, Helen Roberts, Serge Rozenberg, Jan Shifren, James A Simon, Petra Stute, Amanda J Vincent, Wendy Wolfman, Martha Hickey","doi":"10.1097/GME.0000000000002369","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":18435,"journal":{"name":"Menopause: The Journal of The North American Menopause Society","volume":" ","pages":"591-599"},"PeriodicalIF":2.8000,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Recommended measurement instruments for genitourinary symptoms associated with menopause: the COMMA (Core outcomes in menopause) consortium.\",\"authors\":\"Vincent S Paramanandam, Sarah Lensen, 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, Ismaila Aberi Obalowu, David F Archer, Robin J Bell, Monica Christmas, Melanie Davies, Susan R Davis, Karen Giblin, Stamatina Iliodromiti, Unnop Jaisamrarn, Sunila Khandelwal, Ludwig Kiesel, Neelam Aggarwal, Caroline M Mitchell, Gita D Mishra, Rossella E Nappi, Nick Panay, Helen Roberts, Serge Rozenberg, Jan Shifren, James A Simon, Petra Stute, Amanda J Vincent, Wendy Wolfman, Martha Hickey\",\"doi\":\"10.1097/GME.0000000000002369\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>\",\"PeriodicalId\":18435,\"journal\":{\"name\":\"Menopause: The Journal of The North American Menopause Society\",\"volume\":\" \",\"pages\":\"591-599\"},\"PeriodicalIF\":2.8000,\"publicationDate\":\"2024-07-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Menopause: The Journal of The North American Menopause Society\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/GME.0000000000002369\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/5/14 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"OBSTETRICS & GYNECOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Menopause: The Journal of The North American Menopause Society","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/GME.0000000000002369","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/5/14 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"OBSTETRICS & GYNECOLOGY","Score":null,"Total":0}
Recommended measurement instruments for genitourinary symptoms associated with menopause: the COMMA (Core outcomes in menopause) consortium.
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.
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.