Combining electronic healthcare databases in Europe to allow for large-scale drug safety monitoring: the EU-ADR Project
Combining electronic healthcare databases in Europe to allow for large-scale drug safety monitoring: the EU-ADR Project
复制标题
DOI：
10.1002/pds.2053
复制
发表时间：
2011-01-01
影响因子：
2.6
通讯作者：
Sturkenboom, Miriam
中科院分区：
文献类型：
--
作者：
Coloma, Preciosa M.;Schuemie, Martijn J.;Sturkenboom, Miriam
目的在这篇概念验证论文中，我们描述了将欧洲电子医疗记录（EHR）数据库的数据结合起来进行大规模药物安全性监测的框架、过程和初步结果。（丹麦、意大利、荷兰、英国）采用分布式网络方法，通过生成共同输入数据，然后通过定制软件进行本地汇总，跳鼠（c）。比较上消化道出血（UGIB）和非甾体抗炎药（NSAID）使用模式的发生率，以评价数据库之间的数据协调性和质量。非甾体类抗炎药和UGIB的已知关联被用来证明系统的敏感性，通过比较UGIB的发病率比（IRR）在非甾体类抗炎药使用UGIB在所有其他person-time.Results的研究人群包括19 647 445人对应的59 929 690人-年的后续行动。在研究期间确定了39967例UGIB事件病例。根据国家和数据库类型，粗发病率在38.8 - 109.5/10万人-年之间变化，而年龄标准化发病率在25.1 - 65.4/10万人-年之间变化。NSAID使用模式在同一国家的数据库中相似，但在不同国家之间存在差异。在所有数据库中证实了使用任何NSAID与UGIB风险增加之间的统计学显著性年龄和性别调整相关性，IRR从2.0（95%CI：1.7-2.2）到4.3（95%CI：4.1-4.5）。结论结合不同国家EHR数据库的数据来确定药物不良事件相关性是可行的，可以为改变和扩大药物安全性监测的规模奠定基础。版权所有（C）2010约翰威利父子有限公司
Purpose In this proof-of-concept paper we describe the framework, process, and preliminary results of combining data from European electronic healthcare record (EHR) databases for large-scale monitoring of drug safety.Methods Aggregated demographic, clinical, and prescription data from eight databases in four countries (Denmark, Italy, Netherlands, the UK) were pooled using a distributed network approach by generation of common input data followed by local aggregation through custom-built software, Jerboa (c). Comparison of incidence rates of upper gastrointestinal bleeding (UGIB) and nonsteroidal anti-inflammatory drug (NSAID) utilization patterns were used to evaluate data harmonization and quality across databases. The known association of NSAIDs and UGIB was employed to demonstrate sensitivity of the system by comparing incidence rate ratios (IRRs) of UGIB during NSAID use to UGIB during all other person-time.Results The study population for this analysis comprised 19 647 445 individuals corresponding to 59 929 690 person-years of follow-up. 39 967 incident cases of UGIB were identified during the study period. Crude incidence rates varied between 38.8 and 109.5/100 000 person-years, depending on country and type of database, while age-standardized rates ranged from 25.1 to 65.4/100 000 person-years. NSAID use patterns were similar for databases within the same country but heterogeneous among different countries. A statistically significant age-and gender-adjusted association between use of any NSAID and increased risk for UGIB was confirmed in all databases, IRR from 2.0 (95%CI:1.7-2.2) to 4.3 (95%CI: 4.1-4.5).Conclusions Combining data from EHR databases of different countries to identify drug-adverse event associations is feasible and can set the stage for changing and enlarging the scale for drug safety monitoring. Copyright (C) 2010 John Wiley & Sons, Ltd.