皮肤病生活质量指数作为随机临床试验的主要结果:系统性审查
Jeffrey R Johns1, Jui Vyas2, Faraz M Ali1
1Division of Infection and Immunity, School of Medicine, Cardiff University, Cardiff, UK.
The British journal of dermatology
|May 31, 2024
概括
皮肤病生命质量指数 (DLQI) 在5.3%的临床试验中被用作主要结局. 这项研究支持DLQI.
科学领域:
- 皮肤病学 皮肤病学
- 临床试验 临床试验
- 健康 结果 研究 研究 结果
背景情况:
- 患者报告的结果指标 (PROM) 往往是临床试验中的二次终点.
- 一些PROM具有比疾病严重程度测量更严格的验证.
- 这表明PROM可以作为主要终点.
研究的目的:
- 系统地审查使用皮肤病生活质量指数 (DLQI) 作为主要结果的随机对照试验 (RCT).
- 分析DLQI作为主要终点所使用的疾病和干预措施的范围.
主要方法:
- 使用PRISMA指南进行RCT的系统审查.
- 在多个主要科学数据库 (MEDLINE,Embase,Web of Science等) 进行的搜索. ) 的情况.
- 使用Jadad评分的数据提取和偏差风险评估.
主要成果:
- 在457项符合条件的研究中,有24项 (5.3%) 使用DLQI作为主要结局,涉及15种疾病的3436名患者.
- 系统性药物,包括生物药物,是最常见的干预措施 (68%).
- 大多数研究表明偏差风险低至不确定 (87.5%的Jadad得分≥3).
结论:
- 证据支持DLQI作为临床试验中主要结果的使用.
- 这些数据可以指导研究人员和临床医生利用DLQI作为主要结果指标.
- 这些发现凸显了PROM在临床研究中的越来越多的接受度和实用性.
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