亚群疗效模式图(STEPP)法在临床试验中的应用

Application of the subpopulation treatment effect pattern plot(STEPP)method in clinical trials

亚群疗效模式图(subpopulation treatment effect pattern plot,STEPP)法是一种通过制作STEPP,反映研究治疗效应与连续协变量之间关系的方法,其特征为将研究人群根据连续协变量值划分为多个重叠的亚群进行分析。STEPP法与传统亚组分析目的不同,在探究治疗效应与连续协变量的关系上STEPP法有着明显优势。本研究对STEPP法的概念、优势以及亚群划分方法进行了介绍,并以实例介绍了采用R语言的STEPP包进行STEPP法分析的具体操作过程和结果解读方法。

Subpopulation treatment effect pattern plot(STEPP)method is a method for examining the relationship between treatment effects and continuous covariates and is characterized by dividing the study population into multiple overlapping subpopulations to be analyzed based on continuous covariate values.STEPP method has a different purpose than traditional subgroup analyses,and STEPP has a clear advantage in exploring the relationship between treatment effects and continuous covariates.In this study,the concepts,advantages,and subpopulation delineation methods of the STEPP method are introduced,and the specific operation process and result interpretation methods of STEPP method analysis using the STEPP package in R language are presented with examples.