在实践研究网络中使用德国国家药物计划进行临床研究
Patrick Schmutz1, Arthur Krauss1, Sven Dörflinger1
1Reutlingen Research Institute, Reutlingen University, Reutlingen, Germany.
Studies in health technology and informatics
|November 22, 2024
概括
德国国家药物计划 (GNMP) 提供了有价值的临床研究数据,但缺乏互操作性. 一个新的解决方案结合了半自动数据输出和处理,以改善研究的数字化整合.
科学领域:
- 医疗信息学 医疗信息学
- 临床研究数据管理数据管理
- 数字健康记录数字健康记录
背景情况:
- 德国国家药物计划 (GNMP) 是慢性病患者的数字化,强制性记录.
- 从患者数据管理系统 (PDMS) 到电子病例报告表格的GNMP数据的无数字传输对于临床研究至关重要.
- 目前对标准化出口的限制和对药品目录的限制限制阻碍了直接数据集成.
研究的目的:
- 为了解决临床研究数据评估中GNMP缺乏数字互操作性的问题.
- 提出一种解决方案,以促进基于实践的研究网络 (PBRNs) 中有效和准确的数据采集.
- 为了减少在研究期间在全科医生 (GP) 实践中手动输入数据的负担.
主要方法:
- 在GP实践中从PDMS开发半自动化数据出口流程.
- 在研究中心实施手动数据库搜索,以解码药品信息.
- 创建一个半自动化处理管道来管理数据流和工作负载分配.
主要成果:
- 拟议的解决方案有助于将GNMP数据整合到临床研究中.
- 实施了规避措施,以克服当前数据出口和可访问性的限制.
- 该方法旨在平衡GP实践和研究管理之间的工作量.
结论:
- 合并的半自动化方法增强了GNMP用于研究目的的数字互操作性.
- 这种方法提高了数据的准确性,并减少了临床研究数据采集的手工工作.
- 该解决方案支持在基于实践的研究环境中高效的数据评估.
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