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持久表1谬论:对麻醉学和疼痛试验的基线测试的元研究研究

Alessandro De Cassai¹, Burhan Dost², Esra Turunc²

¹Department of Medicine, University of Padua, Padua, Italy; Institute of Anesthesia and Intensive Care Unit, University Hospital of Padua, Padua, Italy.

|September 25, 2025

概括

在麻醉学和疼痛医学随机对照试验 (RCT) 中对基线特征的统计测试仍然很普遍,尽管指南建议不要这样做. 这种做法可能源于对随机化的误解,并可能导致对研究有效性的误解.

科学领域:

麻醉学和疼痛医学麻醉学和疼痛医学
临床试验方法论临床试验方法论
生物统计学生物统计学

背景情况:

随机对照试验 (RCT) 旨在通过随机化实现平衡的基线特征,使这些特征的统计测试不必要且可能具有误导性.
长期以来的指导不鼓励在RCT中测试基线特征,但其在麻醉学和疼痛医学文献中的流行程度尚不清楚.

研究的目的:

调查麻醉学和疼痛医学随机对照试验 (RCT) 中基线特征的统计测试的流行率和模式.
确定与测试基线特征实践相关的因素,并评估统计学意义上的发现率.

主要方法:

1996年至2025年间从101个麻醉学和疼痛医学期刊发表的并行组RCT的元研究研究.
数据提取包括研究特征,基线测试报告,测试变量的数量和统计学意义.
用多变量逻辑回归和二项式测试来分析数据.

主要成果:

在2453个符合条件的RCT中,近一半 (48.3%) 报告了基线特征的统计测试.
在测试基线特征的研究中,19.2%报告至少有一个统计学上显著的差异,比偶然预期的更低.
较大的作者团队与基线测试的几率较低有关,而更多的测试变量增加了发现显著差异的几率.

结论:

对基线特征的统计测试在麻醉学RCT中很常见,尽管有方法指南和CONSORT建议,但并没有减少.
这种做法可能表明对随机化原则的误解,并可能导致对试验有效性的误解.
加强教育和更严格的编辑政策是必要的,以促进遵守最佳实践和提高审判透明度.

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