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区域麻醉试验设计的基于模拟的分析
Melisa Pasli1, Dmitry Tumin2,3, Ryan Guffey4
1Brody School of Medicine, East Carolina University, Greenville, NC, USA.
Anesthesiology research and practice
|March 25, 2024
概括
预计在新块的区域麻醉试验中,样本大小小小. 统计模拟表明,大型试验不太可能,这限制了与安慰剂相比新型阻断疗效的最终结论.
科学领域:
- 麻醉学 麻醉学
- 临床试验 临床试验
- 统计建模 统计建模
背景情况:
- 区域麻醉研究依赖于随机对照试验 (RCT) 来评估新型阻塞.
- 系统性审查经常引用RCT中的小样本大小作为得出坚定的结论的限制.
- 这项研究调查了小样本大小是否是用于具有典型效果大小的新型块的RCT的固有特征.
研究的目的:
- 为了统计模拟预期的样本大小和区域麻醉研究中的大型试验数量,用于新块.
- 确定现有文献中的小样本大小是否是试验设计的可预测结果.
- 探索试验设计的潜在修改,以改善元分析中的数据聚合.
主要方法:
- 模拟了一系列RCT,使用连续结果将新块与安慰剂进行比较.
- 模拟的输入参数来自对元分析的系统文献搜索.
- 主要模拟结果包括预测的大型试验数量 (N ≥256) 和总患者入学率.
主要成果:
- 模拟预测了新块的16个RCT,中位数注册970名患者,没有大型试验 (N ≥256).
- 将显著性值修改为p < 0.005增加了对元分析的患者入学率,但由于区块对区块比较的徒劳,导致了早期试验终止.
- 这些发现表明,小样本大小是当前试验设计的合理结果.
结论:
- 小样本大小是区域麻醉RCT中预期和合理的结果,比较新块与安慰剂.
- 进行大规模试验的可行性不太可能显著改变区块对安慰剂比较的结论.
- 目前的试验设计可能本质上限制了新型区域麻醉技术的证据的确性.
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