开发用于急性缺血性中风干预的设备的协调注册网:基础动脉封闭质量评估试点测试
Jialin Mao1, Sameer A Ansari2, Adnan H Siddiqui3,4
1Population Health Sciences, Weill Cornell Medical College, New York, New York, USA jim2012@med.cornell.edu.
Journal of neurointerventional surgery
|June 11, 2024
概括
聚合基础动脉封闭内血管治疗 (EVT) 的现实数据是可行的. 一个协调的注册网 (CRN) 可以提高对中风护理决策的数据质量.
科学领域:
- 神经学 神经学
- 医疗信息学 医疗信息学
- 临床研究 临床研究
背景情况:
- 现实世界数据 (RWD) 对于评估内血管治疗 (EVT) 在缺血性中风护理中至关重要.
- 一项试点研究从美国注册处汇总了基础动脉阻塞 (BAO) EVT 的数据.
- 该研究评估了共同数据元素 (CDE) 的可用性,完整性,质量和一致性.
研究的目的:
- 评估来自多个BAO EVT注册表的CDE聚合和协调的可行性.
- 评估关键领域可用的数据的质量和一致性.
- 探索创建协调注册表网络 (CRN) 的潜力.
主要方法:
- 来自美国五个注册机构的协调患者级数据.
- 评估了CDE的可用性,完整性 (在≥4个来源中) 和一致性.
- 评估了BAO EVT的七个关键领域的数据质量.
主要成果:
- 来自493个BAO程序 (2013-2020年) 的汇总数据.
- 在88例中,有35例 (40%) 患有CDE;大多数病例>80%被收集.
- 所有七个关键领域都是可以实现的;90天的结果是一个挑战.
结论:
- 试点研究证明了跨注册表汇总和协调CDE的可行性.
- 协调注册表网络 (CRN) 可以增强临床和监管决策的RWD.
- 通过CRN的合作,可以提高对中风治疗研究的数据广度和深度.
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