摘要
临床研究结果的可靠性会受到系统误差风险(偏倚)、随机误差风险(机遇)和设计误差风险(指研究方案设计不能回答提出的临床问题)的影响。三维误差矩阵评估工具提供了从系统误差、随机误差和设计误差维度对临床证据质量进行评估的方法,其主要目的是在尽可能小的误差风险基础上对证据效应值大小和方向进行评估。本文以中药苦参类制剂干预慢性乙型肝炎的疗效和安全性评价为例,对三维误差矩阵的评估方法进行了介绍。
There are three dimensions that could influence the validity of results from clinical researches and they are theoretically accepted as: risk of systematic error(bias), risk of random error(chance), and risk of design error(wrong design to answer the posed question). When overviewing and synthesizing the evidence for a certain clinical question, we should consider these potential risks first. Error matrix is constructed from the three dimensions of errors and serve as a tool to provide visual assessment of reliability of evidence. The overall effort is to minimize all three risks of errors before the size and the direction of the effect can be assessed reliably. This article will introduce the error matrix approach and apply it into the assessment of Radix Sophorae flavescentis versus placebo or no intervention for chronic hepatitis B.
作者
梁宁
孔德昭
刘雪寒
马思思
鲁春丽
王丽琼
刘建平
LIANG Ning;KONG De-zhao;LIU Xue-han;MA Si-si;LU Chun-li;WANG Li-qiong;LIU Jian-ping(Center for Evidence-based Chinese Medicine,Beijing University of Chinese Medicine,Beijing 100029;Copenhagen Trial Unit,Copenhagen University Hospital,Copenhagen 2200;Department of Cardiology,the Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Shenyang110032;Department of Acupuncture and Moxibustion,Dongfang Hospital,Beijing University of Chinese Medicine,Beijing100078)
出处
《中国中西医结合杂志》
CAS
CSCD
北大核心
2019年第7期859-864,共6页
Chinese Journal of Integrated Traditional and Western Medicine
基金
2018年北京中医药大学建设一流大学(学科)和特色发展引导专项师资队伍建设项目(No.1000061020008)
