在Evolut低风险试验中,使用索赔来评估结果和治疗效果
Neel M Butala1,2, Christina Lalani3, Archana Tale3
1Division of Cardiology, Department of Medicine, Rocky Mountain Regional VA Medical Center, Aurora, CO (N.M.B.).
行政索赔准确地识别死亡,致残性中风和跨导管大动脉置换后的起器放置. 这支持将索赔数据用于低风险患者中TAVR的市场后监测.
科学领域:
- 心血管医学 心血管医学
- 医疗保健服务研究 医疗服务研究
- 医疗信息学 医疗信息学
背景情况:
- 在低风险人群中进行过导管大动脉置换 (TAVR) 的市场后研究依赖于与保险索赔相关的注册数据进行长期跟踪.
- 对于这些研究来说,使用与国际疾病分类第十次修订 (ICD-10) 代码的行政索赔来确定临床终点的有效性至关重要.
- 这项研究评估了索赔数据的准确性,以确定试验判断的终点,并评估Evolut低风险试验中的治疗比较.
研究的目的:
- 评估行政索赔数据能够准确识别经过过导管大动脉置换的患者的关键临床终点的能力.
- 确定基于索赔的终点是否可以重现临床试验中的治疗比较.
- 验证使用索赔数据用于TAVR的长期市场后监测.
主要方法:
- 将Evolut低风险试验中的患者链接到Medicare提供者分析和审查数据库.
- 计算的灵敏度,特异性,正预测值,负预测值和kappa (κ) 协议,用于在2年内确定临床终点的声明.
- 用试验判断数据和基于索赔的数据比较治疗臂的结果.
主要成果:
- 索赔数据完美识别了审判判决的死亡.
- 在识别致残性中风 (κ=0.66) 和心脏起器放置 (κ=0.86) 方面观察到良好的表现.
- 对心肌梗塞 (κ=0.46) 和血管并发症 (κ=0.45) 进行了适度的表现. 索赔数据重现了试验的结论,即治疗手臂之间死亡或致残性中风没有显著差异.
结论:
- 基于索赔的终点在TAVR患者的死亡,致残性中风和心脏起器放置方面表现出很好的准确性.
- 使用行政索赔数据可以可靠地复制临床试验中的关键发现.
- 这些发现支持选择性地使用基于索赔的终点来进行跨导管大动脉置换的市场后监测.
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