A Method to Combine Signals from Spontaneous Reporting Systems and Observational Healthcare Data to Detect Adverse Drug Reactions
A Method to Combine Signals from Spontaneous Reporting Systems and Observational Healthcare Data to Detect Adverse Drug Reactions
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DOI：
10.1007/s40264-015-0314-8
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发表时间：
2015-10-01
期刊：
影响因子：
4.2
通讯作者：
Friedman, Carol
中科院分区：
文献类型：
--
作者：
Li, Ying;Ryan, Patrick B.;Friedman, Carol
观察性医疗保健数据包含有助于加速检测药物不良反应（ADR）的信息，这些信息可能会因单独使用自发报告系统（SRS）中的数据而遗漏。只有几篇论文描述了整合医疗保健数据库和SRS证据的方法。我们提出了一种结合这两种来源的ADR信号的方法。本研究的目的是调查所提出的方法是否会导致更准确的ADR检测比方法使用SRS或医疗保健数据单独。我们将该方法应用于四个临床严重的ADR，并使用三个实验进行评估，涉及结合SRS与单个设施的小规模电子健康记录（EHR），一个更大规模的基于网络的EHR，和一个更大规模的医疗索赔数据库。评价使用了包括165个阳性和234个阴性药物-ADR对的参考标准。计算受试者操作特征曲线下面积（AUC）以衡量性能。当SRS和小规模HER组合时，AUC没有改善。SRS和大规模EHR组合的AUC为0.82，而每个单独系统的AUC为0.76。同样，SRS和索赔系统的AUC为0.82，而单个系统的AUC分别为0.76和0.78。当用于合并的资源具有足够的数据量时，所提出的方法显著提高了ADR检测的准确性，证明该方法可以整合来自多个来源的证据，并作为实际药物警戒实践中的工具。
Observational healthcare data contain information useful for hastening detection of adverse drug reactions (ADRs) that may be missed by using data in spontaneous reporting systems (SRSs) alone. There are only several papers describing methods that integrate evidence from healthcare databases and SRSs. We propose a methodology that combines ADR signals from these two sources.The aim of this study was to investigate whether the proposed method would result in more accurate ADR detection than methods using SRSs or healthcare data alone.We applied the method to four clinically serious ADRs, and evaluated it using three experiments that involve combining an SRS with a single facility small-scale electronic health record (EHR), a larger scale network-based EHR, and a much larger scale healthcare claims database. The evaluation used a reference standard comprising 165 positive and 234 negative drug-ADR pairs.Area under the receiver operator characteristics curve (AUC) was computed to measure performance.There was no improvement in the AUC when the SRS and small-scale HER were combined. The AUC of the combined SRS and large-scale EHR was 0.82 whereas it was 0.76 for each of the individual systems. Similarly, the AUC of the combined SRS and claims system was 0.82 whereas it was 0.76 and 0.78, respectively, for the individual systems.The proposed method resulted in a significant improvement in the accuracy of ADR detection when the resources used for combining had sufficient amounts of data, demonstrating that the method could integrate evidence from multiple sources and serve as a tool in actual pharmacovigilance practice.