摘要
协变量是指受试者在接受不同干预措施前,研究者预计的、会对主要变量分析产生重要影响的因素,是临床试验设计和分析时必须考虑的问题之一。在临床试验设计时,应尽可能充分考虑对协变量的控制,可采用随机分组、分层随机化、限定协变量取值的方法使其在组间达到均衡可比。在分析时,可根据主要结果变量和协变量的类型,选择协方差分析、分层分析、线性或广义线性模型等方法进行校正。本研究介绍在确证性临床试验中,如何在设计方案和统计分析计划中事先明确协变量,预先规定主要统计模型来控制协变量。
Covariates are factors which have significant impacts on the primary analysis prior to the subjects being treated. Covariates adjustment should be considered in the design and analysis stages of the clinical trial. Through controlling in the design stage is the optimal resolution;randomization, stratified randomization and restricted covariant values could be used to balance the covariates between comparative treatments. During data analysis stage, analysis of covariance, stratified analysis, linear or generalized linear model can be conducted for covariate adjustment according to different types of outcome and covariate. For confirmatory clinical trial, covariates should be defined in advance in the protocol and statistical analysis plan with the main statistical model.
作者
黄丽红
陈峰
HUANG Lihong;CHEN Feng(Department of Biostatistics,Zhongshan Hospital,Fudan University,Shanghai,200032,P.R.China;Department of Biostatistics,School of Public Health,Nanjing Medical University,Nanjing,211166,P.R.China)
出处
《中国循证医学杂志》
CSCD
北大核心
2019年第12期1498-1502,共5页
Chinese Journal of Evidence-based Medicine
基金
国家自然科学基金项目（编号：81903407）
关键词
协变量
协方差分析
广义线性模型
Covariate
Analysis of covariance
Generalized linear model
