Strobl Judith, Enzer Ian, Bagust Adrian, Haycox Alan, Smyth Rosalind, Ashby Deborah, Walley Tom
Prescribing Research Group, Department of Pharmacology and Therapeutics, Ashton Street New Medical Building, University of Liverpool, L69 3GE, UK.
Pharmacoepidemiol Drug Saf. 2003 Sep;12(6):467-73. doi: 10.1002/pds.804.
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.
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.
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.
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.
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.
囊性纤维化流行病学登记处（ERCF）是一项多中心纵向随访项目，涉及1994年至1999年间在9个欧洲国家约200个中心登记的囊性纤维化患者。
在将ERCF中与7个英国中心（1184例患者）相关的部分数据用于多纳酶（Pulmozyme）的长期成本效益分析之前，我们旨在评估并提高这些数据的质量。具体而言，我们希望评估数据的完整性和准确性以及各中心病例的可比性。
我们使用了ERCF中与7个英国囊性纤维化（CF）中心相关的数据子集。在进行初步数据编辑后，对来自5个中心的患者样本的关键变量数据，对照各中心可用的原始数据源对ERCF数据进行了详细核查。在研究数据集中识别并纠正了ERCF报告与原始数据源之间的差异。此外，还就相关临床和记录操作向各中心工作人员进行了询问。
得益于ERCF对关键变量进行的详细常规数据检查程序，在我们对评估变量的核查过程中，ERCF数据与原始数据之间的差异率总体较低（0.4 - 3.7%）。一些中心似乎少报了某些结局变量（死亡、住院情况）。肺部加重发作难以识别和核实。有24例患者被重复登记（先后在两个不同中心）。各中心在记录规则的解释上存在一些差异。
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流程。除了数据准确性外，关键事件及其发生时间的可靠定义也很重要。应估计少报的程度，尤其是结局变量的少报程度。了解当地临床和报告操作对于解释多中心数据很有必要。数据保护问题可能会限制对二手数据进行详细数据质量评估的可能性，原始数据用于核查的可获取性也是如此。我们的经验和建议可能对那些打算使用疾病登记数据的人以及那些设计和运营此类登记处的人有价值。
