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集群随机交叉临床试验中无呼吸器日的两部分模型
Yungtai Lo1, Xianhong Xie2, Ari Moskowitz3
1Department of Epidemiology & Population Health, Albert Einstein College of Medicine, Bronx, NY, 10461, USA. yungtai.lo@einsteinmed.edu.
BMC medical research methodology
|August 26, 2025
概括
一个新的两部分统计模型提供了在重症监护试验中无呼吸器日的全面分析. 该模型更好地评估干预对死亡率和机械通风持续时间的影响,为研究人员和临床医生提供更深入的见解.
科学领域:
- 危急护理医学
- 生物统计学
- 临床试验方法
背景情况:
- 无呼吸器日 (VFD) 是一个结合死亡率和机械呼吸持续时间的综合终点.
- 目前对静脉呼吸器的分析往往无法区分呼吸器死亡和存活,可能会误导干预效应.
- 集群随机试验中的非医院心肺停止患者是评估呼吸道管理策略的重点.
研究的目的:
- 提出和评估一个新的两部分统计模型来分析无呼吸器日.
- 对比两种呼吸道管理策略 (喉管与内管) 对死亡率和机械通风持续时间的影响.
- 评估共享与独立随机集群效应在集群随机试验的两部分模型中的影响.
主要方法:
- 开发了一个由两部分组成的统计模型:第1部分模型是无法恢复自发循环 (ROSC),ROSC后死亡和存活;第2部分模型是无呼吸机的日子,取决于存活.
- 纳入了随机集群效应,分析了两部分的共享效应与独立效应.
- 模拟研究评估了不同模型规格下的I型错误率和检测干预效应的功率.
主要成果:
- 具有共享随机集群效应的两部分模型显示了适当的I型错误率和在两个模型部分中检测干预效应的提高能力.
- 与内管输入相比,初始的喉管插入降低了未能达到ROSC的几率,并略有降低了ROSC后死亡的几率.
- 一个共享的随机集群效应方法显示,较低的无呼吸器日与较高的死亡率有关,证实了预期的关系.
结论:
- 拟议的两部分统计模型提供了在重症监护研究中对无呼吸器日的干预效应的更全面的评估.
- 这种方法可以更深入地了解干预措施对死亡率,ROSC和机械通风持续时间的影响.
- 这些发现支持在集群随机试验中分析复合终点的两部分共享随机集群效应模型.
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