临床试验中缺失值的处理方法探讨  

Approach to Handling Missing Data in Clinical Trials

作　　者：黎剑锋 张静怡 李立康 刘颖欣 黎国威 LI Jianfeng;ZHANG Jingyi;LI Likang;LIU Yingxin;LI Guowei(School of Public Health,Guangdong Medical University,Dongguan,Guangdong 523808,China;Center for Clinical Epidemiology and Methodology,the Affiliated Guangdong Second Provincial General Hospital of Jinan University,Guangzhou 510317,China)

机构地区：[1]广东医科大学公共卫生学院,广东东莞523808 [2]暨南大学附属广东省第二人民医院临床流行病与方法学中心,广州510317

出　　处：《协和医学杂志》2024年第5期1165-1172,共8页Medical Journal of Peking Union Medical College Hospital

基　　金：广东省广州市科技计划项目(202002030252)。

摘　　要：在临床试验中,因各种原因导致数据缺失属常见现象。缺失值的存在可造成原数据集信息损失,降低研究结果的稳健性和有效性。因此,如何正确处理缺失值是临床试验中必须重视且谨慎对待的问题。本文介绍了临床试验中缺失值的发生原因、类型及常见处理方法,旨在提高研究人员对缺失值的认识,减少缺失值处理方法的误用。需注意的是,临床试验中应对缺失值的最佳方法是严格预防和/或减少数据缺失的发生,而非事后处理。Missing data,occurring in clinical trials due to various reasons,will cause information loss of the original data and reduce the robustness and validity of the research results.Therefore,missing data should be dealt with caution in clinical trials.This article introduces the causes and types of missing data,as well as several common methodological approaches to addressing the problem,in order to promote researchers'understanding and improve the quality of handling missing data in trials.Nevertheless,the best way to deal with missing data is to prevent or reduce data loss in clinical trials,rather than relying on post hoc statistical analyses.

关 键 词：临床试验 缺失值 删除法 插补法 

分 类 号：R181.2[医药卫生—流行病学] R-3[医药卫生—公共卫生与预防医学]