Abstract
邓璇,何寒青,周洋,严睿,唐学雯,朱瑶,徐校平,吕华坤.断点回归设计在真实世界疫苗保护效果评价中的应用[J].Chinese journal of Epidemiology,2022,43(2):292-296
断点回归设计在真实世界疫苗保护效果评价中的应用
Evaluating the real-world vaccine effectiveness using a regression discontinuity design
Received:July 06, 2021  
DOI:10.3760/cma.j.cn112338-20210706-00524
KeyWord: 断点回归设计  疫苗  真实世界研究  保护效果
English Key Word: Regression discontinuity design  Vaccine  Real-world  Protective effectiveness
FundProject:浙江省医药卫生科技计划(2021KY118)
Author NameAffiliationE-mail
Deng Xuan Department of Immunization Program, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, 310051, China  
He Hanqing Department of Immunization Program, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, 310051, China hanqinghe@cdc.zj.cn 
Zhou Yang Department of Immunization Program, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, 310051, China  
Yan Rui Department of Immunization Program, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, 310051, China  
Tang Xuewen Department of Immunization Program, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, 310051, China  
Zhu Yao Department of Immunization Program, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, 310051, China  
Xu Xiaoping Department of Immunization Program, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, 310051, China  
Lyu Huakun Department of Immunization Program, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, 310051, China  
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Abstract:
      疫苗保护效果的真实世界研究是其上市后评价的重要内容,采用断点回归设计进行评价,可以克服随机对照试验的伦理学、现场组织实施等困难,结果更贴近现实,并可提供较高等级的因果推断证据。本文结合实例分析,对断点回归设计的原理、方法、应用场景及未来展望进行介绍与探讨,以期为新型冠状病毒疫苗保护效果的真实世界研究提供思路。
English Abstract:
      Estimating the actual real-world effectiveness of the vaccine is an essential part of the post-marketing evaluation. This regression discontinuity design (RDD) using observational data is designed to quantify the effect of an intervention when eligibility for the intervention is based on a defined cutoff as age, making it suited to estimate vaccine effects. This approach can avoid the high cost and ethical issues; overcome difficulties in the organization and practice process in randomized controlled trials, which leads to a higher level of causal inference evidence and more realistic results. Here, we describe key features of RDD in general, and then specific scenarios, with examples, to illustrate that RDD are an essential tool for advancing our understanding of vaccine effects.
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