Department of Biomedical Informatics, Vanderbilt University School of Medicine, Nashville, Tennessee, United States of America.
PLoS One. 2012;7(4):e33908. doi: 10.1371/journal.pone.0033908. Epub 2012 Apr 6.
Observational studies of health conditions and outcomes often combine clinical care data from many sites without explicitly assessing the accuracy and completeness of these data. In order to improve the quality of data in an international multi-site observational cohort of HIV-infected patients, the authors conducted on-site, Good Clinical Practice-based audits of the clinical care datasets submitted by participating HIV clinics. Discrepancies between data submitted for research and data in the clinical records were categorized using the audit codes published by the European Organization for the Research and Treatment of Cancer. Five of seven sites had error rates >10% in key study variables, notably laboratory data, weight measurements, and antiretroviral medications. All sites had significant discrepancies in medication start and stop dates. Clinical care data, particularly antiretroviral regimens and associated dates, are prone to substantial error. Verifying data against source documents through audits will improve the quality of databases and research and can be a technique for retraining staff responsible for clinical data collection. The authors recommend that all participants in observational cohorts use data audits to assess and improve the quality of data and to guide future data collection and abstraction efforts at the point of care.
观察性研究通常会结合来自多个地点的临床护理数据，而没有明确评估这些数据的准确性和完整性。为了提高国际多地点 HIV 感染患者观察性队列研究数据的质量，作者对参与的 HIV 诊所提交的临床护理数据集进行了现场、基于良好临床实践的审核。使用欧洲癌症研究和治疗组织公布的审核代码对研究数据与临床记录数据之间的差异进行了分类。在关键研究变量（尤其是实验室数据、体重测量值和抗逆转录病毒药物）方面，7 个地点中有 5 个的错误率>10%。所有地点在药物开始和停止日期方面都存在显著差异。临床护理数据，特别是抗逆转录病毒方案及其相关日期，容易出现大量错误。通过审核将数据与原始文件进行核对，可以提高数据库和研究的质量，并可以作为一种技术，用于培训负责临床数据收集的人员。作者建议观察性队列研究的所有参与者使用数据审核来评估和提高数据质量，并指导未来在护理点进行数据收集和提取工作。
