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丹麦西部心脏计算机断层扫描注册研究:一项综述与验证研究。

The Western Denmark Cardiac Computed Tomography Registry: a review and validation study.

作者信息

Nielsen Lene Hüche, Nørgaard Bjarne Linde, Tilsted Hans Henrik, Sand Niels Peter, Jensen Jesper Møller, Bøttcher Morten, Diederichsen Axel C, Lambrechtsen Jess, Kristensen Lone Deibjerg, Mickley Hans, Munkholm Henrik, Gøtzsche Ole, Knudsen Lars Lyhne, Bøtker Hans Erik, Pedersen Lars, Schmidt Morten

机构信息

Department of Cardiology, Lillbaelt Hospital-Vejle, Vejle, Denmark.

Department of Cardiology Aarhus University Hospital-Skejby, Aarhus, Denmark.

出版信息

Clin Epidemiol. 2014 Dec 31;7:53-64. doi: 10.2147/CLEP.S73728. eCollection 2015.

DOI:10.2147/CLEP.S73728
PMID:25657592
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4317160/
Abstract

BACKGROUND

As a subregistry to the Western Denmark Heart Registry (WDHR), the Western Denmark Cardiac Computed Tomography Registry (WDHR-CCTR) is a clinical database established in 2008 to monitor and improve the quality of cardiac computed tomography (CT) in Western Denmark.

OBJECTIVE

We examined the content, data quality, and research potential of the WDHR-CCTR.

METHODS

We retrieved 2008-2012 data to examine the 1) content; 2) completeness of procedure registration using the Danish National Patient Registry as reference; 3) completeness of variable registration comparing observed vs expected numbers; and 4) positive predictive values as well as negative predictive values of 19 main patient and procedure variables.

RESULTS

By December 31, 2012, almost 22,000 cardiac CTs with up to 40 variables for each procedure have been registered. Of these, 87% were coronary CT angiography performed in patients with symptoms indicative of coronary artery disease. Compared with the Danish National Patient Registry, the overall procedure completeness was 72%. However, an additional medical record review of 282 patients registered in the Danish National Patient Registry, but not in the WDHR-CCTR, showed that coronary CT angiographies accounted for only 23% of all nonregistered cardiac CTs, indicating >90% completeness of coronary CT angiographies in the WDHR-CCTR. The completeness of individual variables varied substantially (range: 0%-100%), but was >85% for more than 70% of all variables. Using medical record review of 250 randomly selected patients as reference standard, the positive predictive value for the 19 variables ranged from 89% to 100% (overall 97%), whereas the negative predictive value ranged from 97% to 100% (overall 99%). Stratification by center status showed consistently high positive and negative predictive values for both university (96%/99%) and nonuniversity centers (97%/99%).

CONCLUSION

WDHR-CCTR provides ongoing prospective registration of all cardiac CTs performed in Western Denmark since 2008. Overall, the registry data have a high degree of completeness and validity, making it a valuable tool for clinical epidemiological research.

摘要

背景

作为丹麦西部心脏注册中心(WDHR)的一个子注册库,丹麦西部心脏计算机断层扫描注册中心(WDHR-CCTR)是一个于2008年建立的临床数据库,用于监测和提高丹麦西部心脏计算机断层扫描(CT)的质量。

目的

我们研究了WDHR-CCTR的内容、数据质量和研究潜力。

方法

我们检索了2008 - 2012年的数据,以检查1)内容;2)以丹麦国家患者注册库为参考的程序注册完整性;3)通过比较观察到的与预期的数量来检查变量注册的完整性;以及4)19个主要患者和程序变量的阳性预测值和阴性预测值。

结果

截至2012年12月31日,已登记了近22,000例心脏CT,每个程序最多有40个变量。其中,87%是对有冠状动脉疾病症状患者进行的冠状动脉CT血管造影。与丹麦国家患者注册库相比,总体程序完整性为72%。然而,对丹麦国家患者注册库中登记但未在WDHR-CCTR中登记的282例患者的额外病历审查显示,冠状动脉CT血管造影仅占所有未登记心脏CT的23%,这表明WDHR-CCTR中冠状动脉CT血管造影的完整性>90%。各个变量的完整性差异很大(范围:0% - 100%),但超过70%的所有变量的完整性>85%。以对250例随机选择患者的病历审查作为参考标准,19个变量的阳性预测值范围为89%至100%(总体为97%),而阴性预测值范围为97%至100%(总体为99%)。按中心状态分层显示,大学中心(96%/99%)和非大学中心(97%/99%)的阳性和阴性预测值始终很高。

结论

WDHR-CCTR提供了自2008年以来在丹麦西部进行的所有心脏CT的持续前瞻性登记。总体而言,该注册库数据具有高度的完整性和有效性,使其成为临床流行病学研究的宝贵工具。

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