通过向FDA BEST试点平台的医疗保健数据交换报告的疫苗接种后不良事件病例的数据质量和及时性分析
Matthew Deady1, Ray Duncan2, Lance D Jones1
1IBM Consulting, Washington, DC, United States.
Frontiers in public health
|July 23, 2024
概括
这项研究评估了使用HL7 FHIR进行疫苗接种后不良事件 (AE) 的真实世界数据 (RWD) 交换. 试点平台展示了可行的数据量,快速查询响应时间和良好的数据质量,以改善安全监测.
科学领域:
- 医疗信息学 医疗信息学
- 药物监督 药物监督 药物监督
- 健康数据互操作性 互操作性
背景情况:
- 生物制品有效性和安全性 (BEST) 计划的市场后监督旨在通过使用真实世界数据 (RWD) 增强FDA的能力.
- 由于临床数据共享的局限性,对RWD的互操作数据交换在美国一直是一个挑战.
- 新法规要求通过HL7快速医疗互操作资源 (FHIR) 支持电子健康信息交换.
研究的目的:
- 评估通过FHIR交换的RWD用于研究疫苗接种后不良事件 (AE) 病例的可行性.
- 评估数据量,查询响应时间和数据质量,在一个专为AE监控而设计的试点平台中进行评估.
主要方法:
- 通过试点平台获得的283例疫苗接种后AE病例的RWD.
- 使用描述性统计数据来分析数据量和查询响应时间.
- 根据EHR数据质量框架,应用了322个数据质量测试.
主要成果:
- 每个AE病例的平均临床资源为983.9.9.
- 案例数据的中位查询响应时间为3分30秒.
- 大多数数据元素和市场后监督的符合性要求都得到了满足.
结论:
- 该试点平台展示了使用基于FHIR的RWD交换用于接种后AE监测的可行性.
- 确定了更新当前标准的领域,以解决数据质量差距.
- 这些发现支持通过可互操作的RWD改进市场后监测能力.
关键词:
不良事件 (AE) 是一种不良事件.数据质量数据质量数据质量电子健康记录 (EHR) 是一种电子健康记录.快速医疗互操作性资源 (FHIR)医疗信息技术健康信息技术互操作性互操作性互操作性的互操作性公共卫生公共卫生.现实世界数据 (RWD)更多相关视频
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