大试验和小试验之间的协议:系统审查和元研究分析
Lum Kastrati1,2,3,4, Hamidreza Raeisi-Dehkordi5, Erand Llanaj6,7,8
1Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, California.
JAMA network open
|September 6, 2024
概括
大型试验和较小的试验显示了可比的结果. 然而,在大型试验之前发表的较小试验报告了更有利的结果,这表明需要更多的大规模研究.
科学领域:
- 临床流行病学 临床流行病学
- 超级研究 (Meta-Research) 是一种研究方法.
背景情况:
- 大规模试验为关键研究问题提供了大规模的证据.
- 将大型试验结果与较小试验的元分析进行比较,对于理解证据合成至关重要.
研究的目的:
- 将大型试验的结果与较小试验的元分析结果进行比较.
- 评估大规模试验和聚合较小的研究之间的结果的潜在差异.
主要方法:
- 搜索了clinicaltrials.gov的超级试验和pubmed的元分析,包括这些试验.
- 从大型试验和较小试验分别提取和合成数据,使用随机效应模型.
- 计算了几率比率 (ROR) 的比率,以比较结果,对各种试验特征进行敏感性分析.
主要成果:
- 在主要结局 (ROR,1.00) 或全因死亡率 (ROR,1.00) 方面,大型试验和较小的试验之间没有发现显著差异.
- 在大型试验之前发表的较小试验与大型试验相比,显示出更有利的结果 (ROR,1.05).
- 随后的较小试验也报告了比大型试验更有利的结果 (ROR,1.10).
结论:
- 对较小研究的元分析通常与大型试验结果一致.
- 在大型试验之前发表的较小试验显示出比大型试验更有利的结果.
- 建议增加大型试验的性能,因为它们的数量和意义率较低,以及早期较小试验的趋势显示出更有益的结果.
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