Measuring the Quality of Observational Study Data in an International HIV Research Network
Measuring the Quality of Observational Study Data in an International HIV Research Network
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DOI：
10.1371/journal.pone.0033908
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发表时间：
2012-04-06
期刊：
影响因子：
3.7
通讯作者：
McGowan, Catherine C.
中科院分区：
文献类型：
--
作者：
Duda, Stephany N.;Shepherd, Bryan E.;McGowan, Catherine C.
健康状况和结果的观察性研究通常结合联合收割机临床护理数据从许多网站没有明确评估这些数据的准确性和完整性。为了提高国际多中心观察性HIV感染患者队列的数据质量，作者对参与HIV诊所提交的临床护理数据集进行了基于良好临床实践的现场审核。使用欧洲癌症研究和治疗组织发布的稽查代码对提交用于研究的数据和临床记录中的数据之间的差异进行分类。七个研究中心中有五个在关键研究变量上的错误率>10%，特别是实验室数据、体重测量和抗逆转录病毒药物。所有研究中心的药物开始和停止日期均存在显著差异。临床护理数据，特别是抗逆转录病毒治疗方案和相关日期，很容易出现重大错误。通过审计将数据与源文件进行对比，将提高数据库和研究的质量，并可以成为对负责临床数据收集的工作人员进行再培训的一种技术。作者建议观察性队列的所有参与者使用数据审计来评估和提高数据质量，并指导未来的数据收集和提取工作。
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.