分散试验与传统试验中的治疗效果的协议:元流行病学研究
Louise Chaboud1,2, Perrine Janiaud1,2, Julian Hirt2,3,4
1Department of Clinical Research, University of Bern, 3010 Bern, Switzerland.
概括
分散试验提供与传统试验相比较的治疗效果估计,支持其在临床研究中的使用. 虽然一般相似,但效应大小的适度偏差可能会影响结论,强调需要仔细解释.
科学领域:
- 临床试验方法论 临床试验方法论
- 超流行病学 超流行病学
- 基于证据的医学基于证据的医学.
背景情况:
- 分散试验 (DCT) 代表了一种不断发展的临床研究行为方法.
- 了解DCT与传统非分散试验的比较可靠性对于采用DCT至关重要.
研究的目的:
- 系统地比较来自分散试验和传统非分散试验的治疗效果估计.
- 评估这两种试验设计之间的潜在系统差异或影响估计偏差.
主要方法:
- 采用了一种超流行病学研究设计.
- 数据来源于PubMed数据库,包括被识别为分散的试验及其非分散的对应物.
- 分析的重点是跨不同人群和结果类型的药物干预.
主要成果:
- 我们比较了51个分散的试验和86个解决11个临床问题的非分散的试验.
- 发现分散的试验规模较大 (中位数为1175对236名参与者) 和较新 (中位数为2012年出版年对2007年出版年).
- 没有观察到治疗效果的系统差异 (概率比率的总结比率为1.01),在显著性水平上达成82%的协议;然而,注意到了适度的绝对偏差 (中位数为1.3倍).
结论:
- 分散试验的结论与关于治疗效果的传统随机试验相似.
- 虽然不会系统地高估或低估影响,但可能会出现绝对偏差,可能会影响试验结果.
- 分权化促进了更大的试验,并为参与者提供了好处,扩大了随机研究的范围.
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