Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Australia.
Women's Health Research Program, School of Public Health and Preventive Medicine, Monash University. Melbourne, Australia.
Menopause. 2021 May 10;28(8):859-866. doi: 10.1097/GME.0000000000001788.
Genitourinary symptoms, such as vaginal dryness and pain with sex, are commonly experienced by postmenopausal women. Comparing treatments for these genitourinary symptoms are restricted by the use of different outcome measures in clinical trials and the omission of outcomes, which may be relevant to women. The aim of this project was to develop a Core Outcome Set (COS) to be reported in clinical trials of treatments for genitourinary symptoms associated with menopause.
We performed a systematic review of randomized controlled trials of treatments for genitourinary symptoms associated with menopause and extracted their outcomes. This list was refined and entered into a two-round modified Delphi survey, which was open to clinicians, researchers, and postmenopausal women from November 2019 to March 2020. Outcomes were scored on a nine-point scale from "not important" to "critically important." The final COS was determined following two international consensus meetings.
A total of 26 unique outcomes were included in the Delphi process, which was completed by 227 participants of whom 58% were postmenopausal women, 34% clinicians, and 8% researchers. Predefined thresholds were applied to the Delphi scores to categorize outcomes by importance, which informed the e consensus meetings, attended by 43 participants from 21 countries. The final COS includes eight outcomes: (1) pain with sex, (2) vulvovaginal dryness, (3) vulvovaginal discomfort or irritation, (4) discomfort or pain when urinating, (5) change in most bothersome symptom, (6) distress, bother or interference of genitourinary symptoms, (7) satisfaction with treatment, (8) side effects of treatment.
These eight core outcomes reflect the joint priorities of postmenopausal women, clinicians, and researchers internationally. Standardized collection and reporting of these outcomes in clinical trials will facilitate the comparison of different treatments for genitourinary symptoms, advance clinical practice, and ultimately improve outcomes for symptomatic women.
阴道干燥和性交疼痛等泌尿生殖系统症状是绝经后妇女常见的问题。由于临床试验中使用了不同的结局测量方法，并且遗漏了可能与女性相关的结局，因此比较这些泌尿生殖系统症状的治疗方法受到限制。本项目旨在制定一个核心结局集（COS），以便在治疗与绝经相关的泌尿生殖系统症状的临床试验中报告。
我们对治疗与绝经相关的泌尿生殖系统症状的随机对照试验进行了系统评价，并提取了其结局。对这份清单进行了精炼，并在 2019 年 11 月至 2020 年 3 月期间向临床医生、研究人员和绝经后妇女开放的两轮改良 Delphi 调查中进行了输入。结局的评分采用从“不重要”到“至关重要”的九级评分制。在两次国际共识会议后确定最终的 COS。
共有 26 项独特的结局纳入 Delphi 流程，共有 227 名参与者完成了 Delphi 流程，其中 58%为绝经后妇女，34%为临床医生，8%为研究人员。根据 Delphi 评分的重要性，应用预定义的阈值对结局进行分类，这为有 43 名来自 21 个国家的参与者参加的共识会议提供了信息。最终的 COS 包括八项结局：（1）性交疼痛，（2）阴道干燥，（3）外阴阴道不适或刺激，（4）排尿时不适或疼痛，（5）最困扰症状的变化，（6）泌尿生殖系统症状的困扰、烦恼或干扰，（7）治疗满意度，（8）治疗副作用。
这八项核心结局反映了国际上绝经后妇女、临床医生和研究人员的共同重点。在临床试验中标准化地收集和报告这些结局将有助于比较不同治疗泌尿生殖系统症状的方法，推进临床实践，并最终改善有症状妇女的结局。
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