在骨关节炎临床试验和元分析中测量疼痛结果的基于证据的层次结构
Pakeezah Saadat1, Tiago V Pereira2, Rahim Lalji3
1Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, ON, Canada.
Osteoarthritis and cartilage
|September 6, 2024
概括
总体而言,疼痛是骨关节炎试验中最敏感的患者报告结果指标 (PROM),优于其他患者,如WOMAC疼痛. 这种排名有助于为试验和元分析选择PROM.
科学领域:
- 类风湿病学 类风湿病学
- 临床试验 临床试验
- 疼痛管理 疼痛管理
背景情况:
- 患者报告的结果测量 (PROM) 对于评估骨关节炎 (OA) 临床试验中的疼痛至关重要.
- 选择具有高测定灵敏度的PROM对于准确检测治疗效应至关重要.
研究的目的:
- 在OA试验中根据其测试灵敏度对常用的疼痛PROM进行排名.
- 在OA试验和元分析中提出PROM选择的层次结构.
主要方法:
- 分析了135个OA试验 (57,141名参与者) 与安慰剂/虚假对照.
- 在疼痛PROMs0-100级别上的标准化治疗效果.
- 贝叶斯的多结果合成随机效应模型,根据试验灵敏度对PROM进行排名.
主要成果:
- "整体疼痛"显示了最高的测定灵敏度.
- 从最高到最低的测定灵敏度排名:整体疼痛,楼梯上的疼痛,夜间疼痛,行走上的疼痛,休息的疼痛,WOMAC疼痛,WOMAC全球,莱克斯内指数.
- "整体疼痛"与WOMAC疼痛相比显示了42%的效果大小.
结论:
- "整体疼痛"在OA试验的测定灵敏度方面优于其他疼痛PROM.
- 拟议的PROM层次应该指导PROM选择和数据提取在OA研究.
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