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首页> 外文期刊>Pharmacoepidemiology and drug safety >Using disease registries for pharmacoepidemiological research: a case study of data from a cystic fibrosis registry.
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Using disease registries for pharmacoepidemiological research: a case study of data from a cystic fibrosis registry.

机译：使用疾病登记处进行药物流行病学研究：囊性纤维化登记处数据的案例研究。

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BACKGROUND: The Epidemiologic Registry of Cystic Fibrosis (ERCF) was a multicentre, longitudinal follow-up project of cystic fibrosis patients enrolled at some 200 centres in nine European countries between 1994 and 1999. PURPOSE: We aimed to assess and improve the quality of a subset of data from the ERCF relating to seven English centres (1184 patients), prior to using the data for a long-term cost-effectiveness analysis of dornase alfa (Pulmozyme). Specifically we wanted to assess the completeness and accuracy of the data and the comparability of cases across centres. METHODS: We used a subset of ERCF data relating to seven UK cystic fibrosis (CF) centres. Following initial data editing, key variable data from a sample of patients from five centres were subjected to a detailed verification of ERCF data against original data sources available in the centres. Disagreements between ERCF reports and original data sources were identified and corrected in the study dataset. In addition, centre staff were questioned about relevant clinical and recording practices. RESULTS: Thanks to detailed routine data checking procedures on key variables operated by the ERCF, the rates of disagreement between ERCF data and original data as identified in our verification process on the assessed variables are generally low (0.4-3.7%). Some outcome variables (deaths, hospitalisations) seem to be under-reported by some centres. Episodes of pulmonary exacerbation are difficult to identify and also to verify. Twenty-four patients were registered twice (consecutively in two different centres). There were some differences between centres in their interpretation of recording rules. CONCLUSIONS: Researchers seeking to use disease registry data should consider detailed data quality review processes. Apart from data accuracy, reliable definitions of both critical events as well as their timing are important. The degree of under-reporting, particularly of outcome variables, should be estimated. Information on local clinical and reporting practices is necessary to interpret multi-centre data. Data protection issues may limit the possibilities for detailed data quality assessments of secondary data, as does the accessibility of original data for verification purposes. Our experiences and recommendations may be valuable for those intending to use disease registry data as well as those devising and operating such registries.
机译：背景：囊性纤维化的流行病学注册中心（ERCF）是一项多中心，纵向的囊性纤维化患者纵向随访项目，于1994年至1999年期间在九个欧洲国家的200多个中心就读。目的：我们旨在评估和改善囊性纤维化的质量ERCF的数据子集，涉及七个英国中心（1184名患者），然后将其用于长期评估酶（dulase alfa）（Pulmozyme）。具体来说，我们想评估数据的完整性和准确性以及各中心之间案件的可比性。方法：我们使用了与七个英国囊性纤维化（CF）中心相关的ERCF数据子集。在进行初始数据编辑之后，对来自五个中心的患者样本中的关键变量数据进行了针对中心中可用原始数据源的ERCF数据的详细验证。在研究数据集中发现并纠正了ERCF报告与原始数据源之间的分歧。此外，中心工作人员被问到有关的临床和记录做法。结果：由于对ERCF所操作的关键变量进行了详细的常规数据检查程序，因此我们验证过程中对评估变量的ERCF数据与原始数据之间的不一致率通常很低（0.4-3.7％）。一些中心似乎未对某些结果变量（死亡，住院）进行报告。肺部发作的发作难以识别和验证。 24名患者进行了两次登记（连续在两个不同的中心）。中心在记录规则的解释上存在一些差异。结论：寻求使用疾病登记数据的研究人员应考虑详细的数据质量审查程序。除了数据准确性外，关键事件及其时间的可靠定义也很重要。应当报告不足的程度，尤其是结果变量的不足。有关本地临床和报告实践的信息对于解释多中心数据是必不可少的。数据保护问题可能会限制对辅助数据进行详细数据质量评估的可能性，原始数据出于验证目的的可访问性也会受到限制。我们的经验和建议对于打算使用疾病登记数据的人以及设计和运行此类登记的人可能是有价值的。

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