University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
J Am Coll Cardiol. 2012 Oct 16;60(16):1484-8. doi: 10.1016/j.jacc.2012.07.020. Epub 2012 Sep 19.
The National Cardiovascular Data Registry (NCDR) developed the Data Quality Program to meet the objectives of ensuring the completeness, consistency, and accuracy of data submitted to the observational clinical registries. The Data Quality Program consists of 3 main components: 1) a data quality report; 2) a set of internal quality assurance protocols; and 3) a yearly data audit program.
Since its inception in 1997, the NCDR has been the basis for the development of performance and quality metrics, site-level quality improvement programs, and peer-reviewed health outcomes research.
Before inclusion in the registry, data are filtered through the registry-specific algorithms that require predetermined levels of completeness and consistency for submitted data fields as part of the data quality report. Internal quality assurance protocols enforce data standards before reporting. Within each registry, 300 to 625 records are audited annually in 25 randomly identified sites (i.e., 12 to 25 records per audited site).
In the 2010 audits, the participant average raw accuracy of data abstraction for the CathPCI Registry, ICD Registry, and ACTION Registry-GWTG were, respectively, 93.1% (range, 89.4% minimum, 97.4% maximum), 91.2% (range, 83.7% minimum, 95.7% maximum), and 89.7.% (range, 85% minimum, 95% maximum).
The 2010 audits provided evidence that many fields in the NCDR accurately represent the data from the medical charts. The American College of Cardiology Foundation is undertaking a series of initiatives aimed at creating a quality assurance rapid learning system, which, when complete, will monitor, evaluate, and improve data quality.
国家心血管数据注册中心(NCDR)开发了数据质量计划,以确保提交给观察性临床注册的完整、一致和准确。数据质量计划由 3 个主要部分组成:1)数据质量报告;2)一套内部质量保证协议;3)年度数据审计计划。
自 1997 年成立以来,NCDR 一直是开发绩效和质量指标、现场质量改进计划和同行评审健康结果研究的基础。
在被纳入注册之前,数据要经过注册特定的算法过滤,这些算法要求提交的数据字段达到预定的完整性和一致性水平,作为数据质量报告的一部分。内部质量保证协议在报告之前强制执行数据标准。在每个注册中,每年在 25 个随机确定的地点(即每个审核地点 12-25 个记录)审核 300-625 个记录。
在 2010 年的审核中,CathPCI 注册、ICD 注册和 ACTION 注册-GWTG 的参与者数据提取原始准确性的平均值分别为 93.1%(范围,最小 89.4%,最大 97.4%)、91.2%(范围,最小 83.7%,最大 95.7%)和 89.7.%(范围,最小 85%,最大 95%)。
2010 年的审核提供了证据,证明 NCDR 的许多字段准确地反映了病历中的数据。美国心脏病学会基金会正在采取一系列举措,旨在创建一个质量保证快速学习系统,该系统完成后将监测、评估和改进数据质量。