协和医学杂志2024，Vol.15Issue(2)：422-428,7.DOI:10.12290/xhyxzz.2023-0398
基于真实世界数据的观察性因果推断研究新框架(目标试验模拟)及其在中医药领域中的应用展望
Novel Framework(Target Trial Emulation)in Observational Causal Inference Research Based on Real-world Data and Its Application Prospects in Traditional Chinese Medicine
摘要
Abstract
"Target trial emulation"(TTE),as a new framework in real-world research,has been for-mally established in recent years.It can be used to guide the evaluation of the effectiveness and safety of medi-cal interventions based on real-world data for observational causal inference.The core idea of this framework is to follow the principles of randomized controlled trial(RCT),emulate a corresponding RCT using real-world data,and then draw conclusions about the causal relationship between interventions and outcomes.The main implementation tips of TTE can be summarized as"3-7-2":3 implementation steps including formulating the causal question,designing the emulation plan,and emulating the target study;7 design elements including eligibility criteria,treatment strategies,intervention allocation,follow-up period,outcome,causal contrast of interest,and analysis plan;and control of 2 critical biases including immortal time bias and prevalent user bias.In this article,we present an overview of the development,current status,implementation steps,classic exam-ples,advantages and limitations of TTE,and its application prospects in traditional Chinese medicine(TCM).It is hoped that this article can assist researchers in TCM to utilize this method for real-world research and con-tribute to the construction of a clinical evaluation system with distinctive features of TCM.关键词
目标试验模拟/因果推断/比较效果研究/真实世界数据/中医药临床研究方法Key words
target trial emulation/causal inference/comparative effectiveness research/real-world data/clinical research method of traditional Chinese medicine分类
医药卫生引用本文复制引用
卢存存,陈子佳,王志飞..基于真实世界数据的观察性因果推断研究新框架(目标试验模拟)及其在中医药领域中的应用展望[J].协和医学杂志,2024,15(2):422-428,7.基金项目
中国中医科学院科技创新工程(CI2021A00702) CACMS Innovation Fund(CI2021A00702) （CI2021A00702）
