在临床试验中使用无呼吸器日作为主要结果的样本大小估计:系统性审查
Laurent Renard Triché1, Emmanuel Futier2,3, Manuela De Carvalho4
1Department of Perioperative Medicine, CHU Clermont-Ferrand, 58 Rue Montalembert, 63000, Clermont-Ferrand, France. lrenard--triche@chu-clermontferrand.fr.
Critical care (London, England)
|August 1, 2023
概括
在重症监护试验中,对无呼吸器日 (VFD) 的样本大小估计是具有挑战性的,因为数据偏差和竞争风险. 这次审查发现VFD定义和样本大小方法存在显著的异质性,影响了试验有效性.
科学领域:
- 关键护理医学 关键护理医学
- 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:
- 无呼吸器日 (VFD) 是重症监护研究中的一个关键的复合终点.
- 估计VFD的样本大小是复杂的,因为数据分布和竞争风险.
- 本审查评估了样本大小一致性和VFD试验的替代方法.
结论:
- 一个标准化的定义和VFD的方法,包括核心结果集,是至关重要的.
- 标准化将改善试验解释和构建,特别是样本大小估计.
- 优化样本大小在重症监护试验中平衡成本,伦理和统计能力.
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