建议测量与更年期相关的生殖尿路症状的仪器:COMMA (更年期的核心结果) 联盟
Vincent S Paramanandam1, Sarah Lensen2, Michaela Gabes3
1From the Faculty of Medicine and Health, University of Sydney, Sydney, Australia.
概括
研究人员确定了与更年期相关的生殖尿路症状的患者报告的结果指标 (PROM). 在8个核心结果中,只有3个具有合适的PROM,因此需要对其他结果进行未来开发.
科学领域:
- 更年期研究研究更年期研究.
- 妇科卫生健康 妇科卫生健康
- 患者报告的结果.
背景情况:
- 在更年期时,泌尿生殖系统症状很常见.
- 这些症状的标准化测量对于临床试验和患者护理至关重要.
- 之前努力确定核心成果已经建立.
研究的目的:
- 确定与更年期的生殖尿路症状相关的八个核心结果的适当定义和患者报告的结果指标 (PROM).
- 为临床使用和研究推经过验证的PROM.
主要方法:
- 对出版物的系统审查,以确定定义和PROM.
- 评估已识别的PROM的测量特性.
- 国际共识进程由来自10个国家的28名参与者组成,以最终确定建议.
主要成果:
- 确定了87个出版物和34个PROM.
- 只有五个PROM满足了两个核心结果的标准:"性活动中的疼痛" (PROMIS尺度v2.0) 和"痛苦,烦或干扰" (DIVA问卷).
- 为报告"副作用"的不良事件提出了建议.
结论:
- 在八个核心结果中,仅为三个确定了经过验证的PROM和定义.
- 未来需要进行研究,以开发或验证剩余五个核心结果的PROM.
- 这项工作强调了更好地测量更年期性泌尿器官症状的必要性.
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