疗效比较研究的方法学应用及其实施过程

摘要

疗效比较研究(CER)可有效比较诊疗措施的临床效果,为医疗决策提供证据.其设计除采用大规模临床随机对照试验、整群随机对照试验、类试验、数学模型外,以电子病历为基础的观察性研究备受重视.对研究课题的证据生成、综合、传播及应用的每一环节上,采用CER均需相应的统计学方法进行统计分析和质量控制.%Comparative effectiveness research is able to compare the clinical effects of diagnosis and treatment measures effectively,thus providing evidence for making medical decision.In addition that the large-scale clinical randomized controlled trials,cluster randomized trials,quasi-trial,and mathematical models have started to be used in the designing processes of comparative effectiveness research,observational studies on the foundation of electronic medical records have also been paid enough attention.For each research topic,every procedure on the following areas as:generation of a specific piece of evidence,as well as synthesis,communication,translation and application of related data need to have corresponding statistical methods to perform statistical analysis and quality control.