消除监控过度使用 (EMO) 类型III有效性-取消实施集群-随机试验:统计分析计划
Rui Xiao1, Christopher P Bonafide2,3,4, Nathaniel J Williams5
1Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, Blockley Hall, 423 Guardian Drive, Philadelphia, PA, 19104-6021, USA.
Contemporary clinical trials communications
|October 16, 2023
概括
在EMO试验将测试策略,以停止过度使用脉冲氧计 (SpO2) 监测在患有支气管炎的儿童. 这项研究旨在通过减少不必要的监测实践来提高医疗保健价值.
科学领域:
- 医疗服务研究 医疗服务研究
- 实施科学 实施科学
- 儿科医学 儿科医学 儿科医学
背景情况:
- 过度使用健康干预措施可能会导致伤害和效率低下.
- 连续脉冲氧计 (SpO2) 监测在不需要补充氧气的儿童中经常被过度使用,尽管指南建议不要这样做.
- 消除监控过度使用 (EMO) SpO2试验针对这种与指导方针不一致的做法进行实施.
研究的目的:
- 为了比较两种撤销策略的有效性:单独取消学习与取消学习加替代.
- 评估在室内空气中对患有支气管炎的儿童进行SpO2监测的持续实施.
主要方法:
- 一个混合型3有效性-取消实施试验,具有纵向集群随机设计.
- 针对纵向聚类结果的综合层次混合效应模型,以分析实施的持续性.
- 对二次结果 (住院时间,补氧时间) 的线性混合效应回归.
主要成果:
- 本部分详细介绍了统计分析计划,而不是结果.
- 主要结果是停止实施的持续性,使用差异差异方法进行分析.
- 调解分析将探讨影响实施的医院级因素.
结论:
- 预计EMO试验将通过提供对持续实践变革的见解,推进实施科学.
- 预先规定的统计分析计划将确保严格的评估,并减轻报告偏差.
- 这项研究支持数据驱动的方法来优化医疗保健干预措施.
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