根据数据源对临床试验事件数据的贡献:对可适应的随机临床试验进行预先规定的分析
Jennifer A Rymer1, Hillary Mulder1, Lisa M Wruck1
1Duke Clinical Research Institute, Durham, North Carolina.
JAMA cardiology
|July 24, 2024
概括
电子健康记录 (EHR) 和保险索赔数据在实用随机临床试验 (RCT) 中最有效地识别临床终点. 参与者报告的数据在适应性研究中对事件确定做出了最小的贡献.
科学领域:
- 临床试验 临床试验
- 医疗信息学 医疗信息学
- 心血管研究研究心血管研究
背景情况:
- 实用随机临床试验 (RCT) 经常整合多个数据源进行临床事件评估.
- 这些数据源对临床终点率的比较贡献仍未得到充分研究.
研究的目的:
- 评估电子健康记录 (EHR),保险索赔和参与者报告的数据对ADAPTABLE研究中的临床终点的贡献.
- 了解数据源的不同组合如何在大型实用RCT中影响终点确定.
主要方法:
- 对ADAPTABLE实用RCT数据的分析 (2016年4月至2019年6月).
- 在各种数据源可用性组合 (EHR,索赔,参与者报告) 中对参与者特征进行比较.
- 评估每个数据源所贡献的初级终点事件数量 (死亡,心肌梗塞,中风的组合).
主要成果:
- 在15006名参与者中,组合有所不同,58.3%拥有参与者报告和EHR数据,28.6%拥有所有三种数据类型.
- 对于拥有电子病历和索赔数据的参与者来说,92%-100%的结果被确定在电子病历或索赔数据中.
- 参与者报告的数据不到10%的事件尚未被EHR或索赔数据所捕获.
结论:
- 声明和EHR数据是实用RCT中临床终点数据的主要来源.
- 结果表明在实用试验中收集数据的框架,突出了EHR和索赔数据的主导地位.
- 需要进一步的研究来优化数据源组合,以便在RCT中有效地确定临床终点.
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