最小临床意义差值的概念及其估算方法  

Minimal clinically important difference:terminology and estimated methods

作　　者：杨丽虹[1,2] 刘少南[1,2] 吴大嵘[1] 葛龙 郭新峰[1] YANG Lihong;LIU Shaonan;WU Darong;GE Long;GUO Xinfeng(The Second Affiliated Hospital of Guangzhou University of Chinese Medicine/Guangdong Provincial Hospital of Chinese Medicine,Guangzhou 510120,P.R.China;The Second Clinical College of Guangzhou University of Chinese Medicine,Guangzhou 510405,P.R.China;Evidence-Based Social Science Research Center,School of Public Health,Lanzhou University,Lanzhou 730000,P.R.China)

机构地区：[1]广州中医药大学第二附属医院/广东省中医院,广州510120 [2]广州中医药大学第二临床医学院,广州510405 [3]兰州大学公共卫生学院循证社会科学研究中心,兰州730000

出　　处：《中国循证医学杂志》2020年第11期1345-1352,共8页Chinese Journal of Evidence-based Medicine

基　　金：国家重点研发计划项目(编号:2019YFC1709805);广东省中医药局科研项目(编号:20201151)。

摘　　要：临床研究结果判读不仅需要关注统计学意义(P<0.05),还应关注结果的临床意义。最小临床意义差值(MCID)的提出为结果临床意义的判断提供了依据。此外,MCID还可在指南制订过程中协助证据质量判断、为临床试验提供样本量估算依据和指导临床决策等。本文主要介绍MCID的概念和定义的演变、四种常用估算方法的细节、影响因素、各自的优缺点和适用范围,为研究者进行MCID估算方法选择提供参考和指导。Interpretation of results of clinical research should not only focus on statistical significance(P value less than 0.05)but also clinical significance.The minimal clinically significance difference(MCID)assists to answer the question with the results being clinically significant.In addition,MCID plays an important role in evidence assessment during clinical guideline development,sample size estimation for clinical trials,and clinical decision-making.This paper primarily introduces the terminology and definition of MCID and four common methods used to estimate MCID.

关 键 词：最小临床意义差值 MCID 概念 估算方法 

分 类 号：R195.1[医药卫生—卫生统计学]