对于NU IMPACT阶梯集群随机试验的统计分析计划
Denise M Scholtens1, Nicola Lancki1, Karla Hemming2
1Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States of America.
Contemporary clinical trials
|June 9, 2024
概括
在NU IMPACT试验更新了其统计分析计划,以评估基于电子健康记录 (EHR) 的症状监测系统在癌症护理中. 这确保了对患者采用和实施结果的可靠分析.
科学领域:
- 医疗保健服务研究 医疗服务研究
- 临床信息学 临床信息学
- 在瘤学瘤学.
背景情况:
- 作为IMPACT联盟的一部分,NU IMPACT试验评估了在门诊癌症护理中嵌入电子健康记录 (EHR) 的症状监测和管理计划.
- 它采用一个阶梯集群随机设计,用于实施结果和一个患者级随机试验,用于有效性结果.
- 统计分析计划的更新是由于需要在阶段试验中使用先进的方法来推动的.
研究的目的:
- 详细说明NU IMPACT试验中实施结果的更新统计分析计划.
- 概述主要和次要的实施结果措施及其分析方法.
- 确保严格和标准化的方法来分析试验的实施数据.
主要方法:
- 主要实施结果,即患者采用 (临床层面的每月患者参与EHR系统),将使用通用最小平方线性回归来分析.
- 分析包括自动回归错误,并对集群和时间效应进行调整,以考虑潜在的世俗趋势.
- 二次患者和提供者实施结果将使用类似的分析策略.
主要成果:
- 摘要不包含具体结果,因为它侧重于更新的统计分析计划.
- 该计划规定了分析患者采用和其他实施结果的方法.
- 该方法旨在提供基于EHR的症状监测计划的可靠评估.
结论:
- 分析更新反映了统计学家,实施科学家和试验领导者之间的协作努力.
- 这份修订后的统计分析计划为分析NU IMPACT试验中的实施结果提供了先验指定的方法.
- 更新的计划确保了一个严格的基础来评估基于EHR的症状监测系统的实施.
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