Hoffmann F, Andersohn F, Giersiepen K, Scharnetzky E, Garbe E
Universität Bremen, Bremen, BRD.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2008 Oct;51(10):1118-26. doi: 10.1007/s00103-008-0646-y.
Medical records databases (such as the General Practice Research Database-GPRD) and administrative databases (such as German Statutory Health Insurance (SHI) claims data) are useful sources for pharmacoepidemiology and health services research. However, these data are not primarily collected for research purposes. Validation studies are needed to examine their completeness and accuracy depending on the corresponding research question. This article reviews strategies for checks of internal consistency within the data from one SHI as well as between data from several SHIs and possibilities of internal data validation. Descriptive analyses of consistency can help to determine the integrity of data. The aim of internal validation is to separate uncertain from true cases based on information from secondary data alone or to reproduce known associations within the database. In addition external validation of secondary data is desirable using original prescriptions, medical records, hospital discharge letters and/or patient or physician interviews as a gold standard. A considerable number of external validation studies of diagnostic coding have been conducted within the GPRD. In contrast, such validation studies of German SHI claims data are mostly lacking and are urgently needed in the near future.
医疗记录数据库（如全科医疗研究数据库-GPRD）和行政数据库（如德国法定医疗保险（SHI）理赔数据）是药物流行病学和卫生服务研究的有用数据源。然而，这些数据并非主要为研究目的而收集。需要进行验证研究，以根据相应的研究问题检查其完整性和准确性。本文回顾了检查来自一个SHI的数据内部一致性以及几个SHI数据之间的一致性的策略，以及内部数据验证的可能性。一致性的描述性分析有助于确定数据的完整性。内部验证的目的是仅根据二次数据中的信息将不确定病例与真实病例区分开来，或在数据库中重现已知的关联。此外，使用原始处方、医疗记录、医院出院信和/或患者或医生访谈作为金标准对二次数据进行外部验证是可取的。在GPRD内已经进行了大量关于诊断编码的外部验证研究。相比之下，德国SHI理赔数据的此类验证研究大多缺乏，在不久的将来迫切需要。
