在重症监护医学的阶段集随机试验中,样本大小要求和集群内相关性:实用指南
Thomas Hughes-Gooding1, Diva Baggio2, Edward Litton3,4
1Intensive Care Unit, Wellington Hospital, Wellington, New Zealand.
概括
循序渐进的子集群试验是可行的ICU干预使用常规数据. 这项研究为规划未来试验提供了澳大利亚和新西兰特定的参数,增强了大规模的ICU研究.
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
- 医疗保健服务研究 医疗服务研究
背景情况:
- 逐步集群随机试验 (SW-CRTs) 越来越多地用于评估医疗保健机构的干预措施.
- 规划SW-CRT需要准确的统计参数,例如集群内相关系数 (ICC) 和集群自相关系数 (CAC).
- 澳大利亚和新西兰的重症监护室 (ICU) 为大规模临床研究提供了独特的环境.
研究的目的:
- 估计澳大利亚和新西兰ICU规划SW-CRT的关键统计参数.
- 为在这种环境中设计未来的SW-CRT提供实际指导.
- 使用常规收集的ICU数据评估SW-CRT的可行性.
主要方法:
- 在2010年至2023年期间,在澳大利亚和新西兰的132个成年公共医院ICU中使用例行收集的数据进行了一项横截面的回顾性观察性研究.
- 集群内部相关系数 (ICC) 和集群自相关系 (CAC) 估计使用可交换,可块交换和离散时间衰变模型.
- 数据包括所有成人ICU入院患者,分析重点关注ICU入院后90天内住院死亡率.
主要成果:
- 分析了超过129万 ICU 入院病例,观察到的死亡率在特定子组中从10.3%到23.0%不等.
- 估计的ICCs在0.008到0.022之间,CACs在0.83到1.00之间.
- 区块可交换或离散时间衰变模型通常为数据提供了最适合的模型. 一个工作示例显示,在模拟试验中,81.6%的功率检测到2.7%的绝对死亡率降低.
结论:
- 阶段子集群随机试验是可行的评估ICU全方位干预,当常规数据可用时.
- 估计的ICC和CAC参数是特定于澳大利亚和新西兰的ICU环境,有助于未来试验规划.
- 这项研究强调了SW-CRT设计在重症监护机构实用性,大规模研究的潜力.
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