从电子医疗记录创建药物治疗观察研究数据库:挑战和数据策划
Wolfgang Rödle1, Hans-Ulrich Prokosch1, Eva Neumann2
1Chair of Medical Informatics, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany.
Applied clinical informatics
|February 7, 2024
概括
这项研究从电子医疗记录中创建了一个高质量的观察性研究数据库,尽管存在数据质量挑战,但改善了儿科药物利用研究. 精心策划的数据库增强了对儿童药物安全性的理解.
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
- 儿科研究 儿科研究
背景情况:
- 观察性研究利用医院治疗数据的二次使用来补充实验研究和临床试验.
- 了解儿科药物使用对于建立更安全的药物疗法至关重要.
- 儿科电子医疗记录中的临床文档往往存在数据质量问题,需要进行广泛的策划.
研究的目的:
- 将部门的电子病历数据转换和整理成一个观察性研究数据库.
- 在电子医疗记录中识别数据质量问题及其原因.
- 描述一个系统的数据整理过程,以生成高质量的研究数据.
主要方法:
- 从德国一所大学儿童医院的电子医疗记录系统提取数据 (2012年4月 - 2020年6月).
- 实施一个由四个步骤组成的数据准备,映射和策划过程.
- 使用3x3准则进行数据质量评估,并与黄金标准进行比较.
主要成果:
- 从21,285次临床接触中生成了一个数据集,包括770,158次药物处方和89,955次药物暴露.
- 叙述性药物治疗描述被映射到标准化术语中,提高了数据的一致性.
- 数据库显示与正确性质量标准的黄金标准高度一致.
结论:
- 一个半自动化的数据策划过程成功地解决了电子医疗记录中的数据质量问题.
- 由此产生的高质量的观察研究数据库支持儿科药物使用研究.
- 局限性包括由于原始文件中的不一致性,缺乏详细的剂量信息.
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