使用电子健康记录数据用于药物安全信号识别:一个范围审查
Sharon E Davis1,2, Luke Zabotka3, Rishi J Desai3,4
1Department of Biomedical Informatics, Vanderbilt University Medical Center, 2525 West End Ave, Suite 1475, Nashville, TN, 37203, USA.
Drug safety
|June 20, 2023
概括
电子健康记录 (EHR) 为药物监测提供了潜力,但目前从EHR数据中识别药物安全信号的方法是不一致的. 开发最佳实践对于有效的基于EHR的安全监测至关重要.
科学领域:
- 药物监督和药物流行病学
- 医疗信息学 医疗信息学
- 药品安全 药品安全
背景情况:
- 药物监测计划对于患者安全至关重要,传统上依赖于索赔数据和自发报告.
- 电子健康记录 (EHR) 提供了新的机会,以加强营销后药物安全监测.
- 传统的药物监测方法存在限制,电子健康记录可能会解决这些问题.
研究的目的:
- 通过使用EHR数据进行范围文献审查,评估药物安全信号识别的当前状态.
- 评估研究设计,数据元素,分析方法和基于EHR的药监监测研究中的统计考虑.
主要方法:
- 对利用患者级EHR数据用于药物安全信号检测的研究的系统范围文献综述.
- 提取研究设计,电子健康记录数据元素,分析技术,药物/结果和统计选择的数据.
- 分析了81项符合条件的研究,以确定方法的趋势和变化.
主要成果:
- 不成比例方法是最常见的分析方法,其次是数据挖掘和回归技术.
- 在研究设计,数据利用,混调整和跨研究的统计考虑方面观察到显著的变化.
- 由于方法的异质性,研究之间的直接比较具有挑战性.
结论:
- 目前基于EHR的药监工作并没有充分利用现有的数据或严格解决混因素.
- 通过最佳实践和共同数据模型进行标准化是必要的,以推进基于EHR的药物安全监测.
- 需要进一步开发以最大限度地发挥EHR在识别药物安全信号方面的潜力.
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