使用观察性,现实世界的数据评估心脏安全性:EP PASSION概念验证研究
Lorenzo Braghieri1, Aamir Ahmed2, Anne B Curtis2
1Department of Internal Medicine, Cleveland Clinic, Cleveland, Ohio.
Heart rhythm
|June 27, 2024
概括
现实世界的数据 (RWD) 与传统的批准后研究 (PAS) 方法密切匹配,用于检测心脏并发症. 这项概念验证研究表明,RWD可以增强对安全性的临床证据生成.
科学领域:
- 心血管医学 心血管医学
- 医疗器械安全 医疗器械安全
- 医疗信息学 医疗信息学
背景情况:
- 对于心脏导的传统后审批研究 (PAS) 有局限性.
- 监管机构接受PAS设计用于市场营销后的要求.
研究的目的:
- 进行概念验证研究,评估使用真实世界数据 (RWD) 的替代方法.
- 评估RWD在评估大患者群体中心脏安全性的实用性.
主要方法:
- 与医疗保险服务费用 (FFS) 索赔相关联的阿博特患者设备数据库.
- 对比RWD方法与PAS用于检测444名患者的机械相关并发症.
- 使用麦克纳马测试和科恩测试评估一致性 κ;比较没有并发症的3年生存率.
主要成果:
- 在PAS报告的并发症和索赔检测的并发症之间完全一致 (McNemar P=1;Cohen κ=1).
- 没有并发症的3年生存率为RWD的98.4%,PAS的98.4%.
- RWD结果在±2.5%的等效标准内.
结论:
- 现实世界数据 (RWD) 与传统的批准后研究 (PAS) 对并发症率的发现密切一致.
- 基于RWD的方法显示出增强对心脏安全性的临床证据生成的潜力.
- 这项研究支持使用RWD作为传统PAS的可行替代方案或补充.
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