协和医学杂志

2018, v.9(02) 177-182

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电子病历数据库在临床研究中的应用及偏倚控制
Database of Electronic Health Records: Application in Clinical Research and Bias Control

王丽;程凯亮;
WANG Li;CHENG Kai-liang;Department of Epidemiology and Biostatistics,Institute of Basic Medical Sciences,Chinese Academy of Medical Sciences &Peking Union Medical College;

摘要(Abstract):

电子病历数据库(electronic health records,EHRs)的出现为大样本临床队列研究提供了低成本、高效率的愿景和机遇,但利用EHRs开展临床研究仍然存在误区和挑战。本文回归流行病学的本质,通过实例探讨EHRs的特征,EHRs中可获得的信息与临床研究中暴露变量、结局变量及协变量之间的对应关系,如何利用EHRs进行患病率及发病率估计、开展疗效和政策评价以及在临床研究中对选择偏倚、混杂偏倚尤其是未测量混杂偏倚的控制等,旨在促进EHRs与临床研究的整合,提高临床研究的效率及质量。
The emergence of electronic health records(EHRs) provides a good opportunity for clinical studies to be carried out on large samples with high efficiency and at low costs. However,misunderstanding and inappropriate application of EHRs in clinical research are common. This paper brings us back to the essentials of epidemiology. We use a number of examples to discuss: the characteristics of EHRs,the relationship of data domains of EHRs with their corresponding variables(exposure,outcomes,and covariates) in epidemiological research,and how to use EHRs to estimate prevalence and incidence and to evaluate the effectiveness of treatment and policy. We also focus on the selection bias and confounding controls,especially unmeasured confounding controls. Hopefully,this paper would contribute to the integration of EHRs and clinical research and to the improvement of efficiency and quality of clinical research.

关键词(KeyWords): 电子病历数据库;临床研究;偏倚控制
electronic health records;clinical research;bias control

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基金项目(Foundation): 公益性卫生行业专项(201502005)

作者(Author): 王丽;程凯亮;
WANG Li;CHENG Kai-liang;Department of Epidemiology and Biostatistics,Institute of Basic Medical Sciences,Chinese Academy of Medical Sciences &Peking Union Medical College;

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