Division of Epidemiology, Human Genetics, and Environmental Sciences, The University of Texas School of Public Health at Houston, Houston, TX 77030, USA.
BMC Neurol. 2013 Jun 15;13:61. doi: 10.1186/1471-2377-13-61.
Limited information has been published regarding standard quality assurance (QA) procedures for stroke registries. We share our experience regarding the establishment of enhanced QA procedures for the University of Texas Houston Stroke Registry (UTHSR) and evaluate whether these QA procedures have improved data quality in UTHSR.
All 5093 patient records that were abstracted and entered in UTHSR, between January 1, 2008 and December 31, 2011, were considered in this study. We conducted reliability and validity studies. For reliability and validity of data captured by abstractors, a random subset of 30 records was used for re-abstraction of select key variables by two abstractors. These 30 records were re-abstracted by a team of experts that included a vascular neurologist clinician as the "gold standard". We assessed inter-rater reliability (IRR) between the two abstractors as well as validity of each abstractor with the "gold standard". Depending on the scale of variables, IRR was assessed with Kappa or intra-class correlations (ICC) using a 2-way, random effects ANOVA. For assessment of validity of data in UTHSR we re-abstracted another set of 85 patient records for which all discrepant entries were adjudicated by a vascular neurology fellow clinician and added to the set of our "gold standard". We assessed level of agreement between the registry data and the "gold standard" as well as sensitivity and specificity. We used logistic regression to compare error rates for different years to assess whether a significant improvement in data quality has been achieved during 2008-2011.
The error rate dropped significantly, from 4.8% in 2008 to 2.2% in 2011 (P < 0.001). The two abstractors had an excellent IRR (Kappa or ICC ≥ 0.75) on almost all key variables checked. Agreement between data in UTHSR and the "gold standard" was excellent for almost all categorical and continuous variables.
Establishment of a rigorous data quality assurance for our UTHSR has helped to improve the validity of data. We observed an excellent IRR between the two abstractors. We recommend training of chart abstractors and systematic assessment of IRR between abstractors and validity of the abstracted data in stroke registries.
有关中风登记处标准质量保证(QA)程序的信息有限。我们分享了在德克萨斯大学休斯顿中风登记处(UTHSR)建立增强 QA 程序方面的经验,并评估了这些 QA 程序是否提高了 UTHSR 的数据质量。
本研究考虑了 2008 年 1 月 1 日至 2011 年 12 月 31 日期间在 UTHSR 中提取和输入的所有 5093 名患者记录。我们进行了可靠性和有效性研究。对于记录员记录的数据的可靠性和有效性,使用随机抽取的 30 个记录,由两名记录员重新提取选择的关键变量。这些 30 个记录由包括血管神经病学临床医生在内的专家小组重新提取,作为“金标准”。我们评估了两名记录员之间的组内相关系数(IRR)以及每位记录员与“金标准”的有效性。根据变量的范围,使用 2 种方法、随机效应方差分析,采用 Kappa 或组内相关系数(ICC)来评估 IRR。为了评估 UTHSR 中数据的有效性,我们重新提取了另一组 85 名患者的记录,其中所有不一致的条目均由血管神经病学研究员临床医生裁决,并添加到我们的“金标准”中。我们评估了登记处数据与“金标准”之间的一致性以及敏感性和特异性。我们使用逻辑回归比较不同年份的错误率,以评估在 2008-2011 年期间数据质量是否得到显著提高。
错误率从 2008 年的 4.8%显著下降到 2011 年的 2.2%(P < 0.001)。两名记录员在几乎所有检查的关键变量上都具有极好的 IRR(Kappa 或 ICC≥0.75)。UTHSR 中的数据与“金标准”之间的一致性几乎在所有分类和连续变量上都非常好。
为 UTHSR 建立严格的数据质量保证有助于提高数据的有效性。我们观察到两名记录员之间具有极好的 IRR。我们建议对图表记录员进行培训,并对中风登记处中记录员之间的 IRR 和提取数据的有效性进行系统评估。