更年期血管运动症状的推测量仪器:COMMA (更年期的核心结果) 联盟
Sarah Lensen1, Vincent S Paramanandam, Michaela Gabes2
1From the Department of Obstetrics and Gynaecology, Royal Women's Hospital, University of Melbourne, Melbourne, Australia.
这项研究确定了更年期血管运动症状的患者报告结果指标 (PROM),并推一个应对痛苦和睡眠影响的指标. 然而,适合症状频率,严重程度和治疗满意度的PROM仍未开发.
科学领域:
- 更年期研究研究更年期研究.
- 临床试验方法论 临床试验方法论
- 患者报告的结果
背景情况:
- 血管运动症状是绝经期间妇女的一个关键问题.
- 在COMMA (更年期的核心结果) 项目中,确定了评估这些症状的六个核心结果.
- 这些结果的标准化测量对于临床研究和实践至关重要.
研究的目的:
- 确定六个核心更年期血管运动症状结果的适当定义和患者报告的结果指标 (PROM).
- 建立关于测量症状频率,严重程度,痛苦,睡眠影响,治疗满意度和副作用的最佳方法的共识.
主要方法:
- 一个系统的文献审查确定了定义和PROMs.
- 一个涉及16个国家的36名专家的全球共识过程审查和推措施.
- 评估了PROM与核心结果和测量属性的相关性.
主要成果:
- 确定了40个PROM,但只有4个符合两个核心结果的标准.
- 建议使用热闪相相关的每日干扰量表来测量痛苦/烦/干扰和睡眠影响.
- 对"副作用"的六个定义进行了审查;建议报告不良事件.
结论:
- 在六个核心结果中,只确定了三个合适的PROM.
- 对于症状频率,严重程度或治疗满意度,没有发现经过验证的PROMs.
- 对于剩余的核心结果,需要开发和验证新的PROM.
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