基于医疗大数据的比较效果研究设计要点述评与应用

Key Comments and Applications of Comparative Effect Research and Design Based on Medical Big Data in China

随着医疗信息化建设进程加快,我国医疗卫生领域已进入大数据时代,这为开展基于真实世界的比较效果研究提供了充分条件。比较效果研究是一种评价不同医疗干预方案在真实世界中效果的研究,其结果可指导临床实践或为政策制定提供证据支持。基于医疗大数据开展比较效果研究时研究者需注意明确研究问题与研究设计、混杂和偏倚的可能来源以及控制混杂和偏倚的统计分析技术,从而增强因果关系推论。基于中国目前研究现状,我国应加强对医疗大数据的利用,同时还要提升研究设计和步骤的规范性,从而提高研究结论的可靠性和提供优质证据。

With the rapid development of the health informatization construction in China,health care has entered the era of big data,which provides sufficient condition for conducting comparative effectiveness research(CER)based on real world.CER is defined as a study for the evaluation of different medical intervention programs in‘real world’settings,and its results can guide the clinical practice,providing evidence support for policy making.Researchers need to focus on clearing research questions and research design,possible sources of confounding and bias,and statistical analysis techniques to control confounding and biasing based on medical big data and to enhance the causality inference.Based on China’s current research status,China should strengthen the use of medical big data,and meanwhile improve the standardization of research design and procedures,so as to improve the reliability of research conclusions and provide high-quality evidence.