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瑞典心脏注册研究中的数据质量评估:来自关于完整性和准确性的系列审计的见解

Data quality assessment in the SWEDEHEART registry: Insights from serial audits on completeness and accuracy.

作者信息

Leosdottir Margret, Dahlbom Lars, Bäck Maria, Wallentin Lars, Alfredsson Joakim, Erlinge David, Jernberg Tomas, Hagström Emil

机构信息

Department of Clinical Sciences Malmö, Faculty of Medicine, Lund University, Sweden; Department of Cardiology, Skane University Hospital, Malmö, Sweden.

Department of Cardiology, Bollnäs Hospital, Bollnäs, Sweden; Uppsala Clinical Research Centre, Uppsala, Sweden.

出版信息

Am Heart J. 2025 Oct;288:149-158. doi: 10.1016/j.ahj.2025.04.028. Epub 2025 May 1.

Abstract

BACKGROUND

Registry data used to monitor clinical care need to be reliable, and the process for assuring data quality transparent. Here the auditing process of the Swedish quality registry for cardiac disease, SWEDEHEART, is described.

METHODS

SWEDEHEART audits have been performed at 4 time-points in 2011 to 2018, with data quality audited in the 3 largest subregistries covering acute coronary syndromes (ACS), percutaneous coronary interventions (PCI), and cardiac rehabilitation (CR). Data is audited against electronic medical records by 4 controllers, centrally coordinated by a project leader. During the 2011 audit 13/71 (18.3%) of ACS-admitting hospitals and 8/28 (28.6%) of coronary catheterization labs reporting to the registry were audited. During the 2017 to 2018 audit all reporting sites (100.0%) were audited: 72 hospitals, 30 catheterization labs, and 75 CR centres, with more than 200,000 data points controlled.

RESULTS

Overall data completeness in the 2017 to 2018 audit was as follows: SWEDEHEART-ACS 99.1%, SWEDEHEART-PCI 99.2%, and SWEDEHEART-CR 94.5%. The accuracy of registry data compared to electronic medical records was >95.0% for all subregistries at all 4 audits (P for trend < .0001), in 2017 to 2018 as follows: SWEDEHEART-ACS 97.5%, SWEDEHEART-PCI 98.4%, and SWEDEHEART-CR 95.8%. Data most often incomplete or inconsistent were data on time points, self-reported data, and data reliant on complex definitions.

CONCLUSION

The SWEDEHEART registry is a highly complete and accurate source of patient characteristics and processes of care, that can be reliably used for quality improvement such as monitoring quality of care, to compare hospitals at site- and national level, include in international comparisons, and for conducting high-quality registry-based research.

摘要

背景

用于监测临床护理的登记数据需要可靠,且确保数据质量的过程应透明。本文描述了瑞典心脏病质量登记系统SWEDEHEART的审核过程。

方法

2011年至2018年期间在4个时间点进行了SWEDEHEART审核,对涵盖急性冠状动脉综合征(ACS)、经皮冠状动脉介入治疗(PCI)和心脏康复(CR)的3个最大子登记系统的数据质量进行了审核。由4名审核员对照电子病历进行数据审核,由一名项目负责人进行集中协调。在2011年的审核中,对向该登记系统报告的71家ACS收治医院中的13家(18.3%)和28家冠状动脉导管实验室中的8家(28.6%)进行了审核。在2017年至2018年的审核中,对所有报告地点(100.0%)进行了审核:72家医院、30家导管实验室和75个CR中心,审核了超过200,000个数据点。

结果

2017年至2018年审核中的总体数据完整性如下:SWEDEHEART-ACS为99.1%,SWEDEHEART-PCI为99.2%,SWEDEHEART-CR为94.5%。在所有4次审核中,所有子登记系统的登记数据与电子病历相比的准确性均>95.0%(趋势P<0.0001),2017年至2018年如下:SWEDEHEART-ACS为97.5%,SWEDEHEART-PCI为98.4%,SWEDEHEART-CR为95.8%。最常不完整或不一致的数据是时间点数据、自我报告数据以及依赖复杂定义的数据。

结论

SWEDEHEART登记系统是患者特征和护理过程的高度完整且准确的来源,可可靠地用于质量改进,如监测护理质量、在现场和国家层面比较医院、纳入国际比较以及开展基于高质量登记系统的研究。

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