开发和实施一个开放的,模块化的,参与性的工具链,用于医疗保健研究中的分布式IT开发 - - 学习的经验
Daniel Neumann1, Richard Gebler2, Jana Kiederle3
1Institute for Medical Informatics, Statistics and Epidemiology (IMISE), University Leipzig, Germany.
Studies in health technology and informatics
|September 3, 2025
概括
这项研究提供了一个分散的工具链,用于将临床数据转换为准备研究的格式,使用HL7 FHIR标准,使多个机构能够进行可扩展,符合标准的临床研究.
科学领域:
- 医疗信息学
- 卫生数据标准
- 临床研究基础设施
背景情况:
- 分布式医疗保健研究基础设施努力将常规临床数据协调为准备研究的格式,使用HL7 FHIR标准.
- 现有的FHIR管道通常假定语义上有效的数据,在单一机构中运行,并且缺乏对受监管的异质环境的指导.
研究的目的:
- 开发一个开放的,模块化的,参与性的工具链,以实现基于FHIR的分散数据转换和出口.
- 在多个受监管的医疗机构中部署数据转换工具的挑战.
主要方法:
- 开发了一个支持FHIR提取,基于配置的转换,REDCap集成和OMOP兼容的出口的工具链.
- 适应当地基础设施,监管边界 (例如,非识别数据,限制访问) 和临床需求的工具链.
- 实施可配置模块,代理支持,并为医院工作流集成提供特定的适应.
主要成果:
- 在德国医疗信息化倡议 (MII) 和INTERPOLAR项目中成功部署了多个数据集成中心 (DIC) 的分散工具链.
- 证明了工具链适应不同的当地基础设施和监管要求的可行性.
- 确定了技术,内容和跨站点一致性的基本验证模块.
结论:
- 集中的开发与去中心化的参与部署为嵌入式临床研究创建了可扩展的,符合GDPR的基础设施.
- 这种方法为多个地点的举措提供了可复制的框架,利用各种环境中的真实数据.
- 早期获取真实数据和可适应的验证工具对于成功实施至关重要.
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