2010版CONSORT声明:平行组随机试验报告的新指南

CONSORT 2010 Statement:New version guidelines for reporting parallel group randomised trials

平行组随机试验(parallel group random-ised trials)的统一报告格式CONSORT声明于1996年首次发表后,在实用中受到好评,对规范试验报告格式、提高试验报告质量发挥了重要作用,可作为试验报告的作者、审稿人和编者撰写、评价和发表的重要指南。本着不断改进的宗旨,CONSORT声明于2001年进行了修订,2010年再次进行修订。目前,国际上400多本期刊和3个主流的国际性编辑组织对CONSORT给予官方支持。最新版本CONSORT2010改进了以前核查单的特定性和清晰性。本文将对2010版的CONSORT声明进行介绍,展示报告平行组随机对照试验的完整指南框架,期望对规范我国临床试验报告工作有所裨益,以不断提高我国临床试验报告的质量。

The CONSORT statement which published first in 1996 meant a consolidated standards of reporting trials and comprised a checklist and flow diagram.The checklist and diagram were primarily intended for use in writing,reviewing or evaluating reports of parallel group randomized trials.The statement was a continually-evolving document.The revised CONSORT statement was presented in 2001 and 2010.More than 400 journals and three leading editorial groups across the world have now given their official support to CONSORT.The latest version,CONSORT 2010,improves the specificity and clarity of the previous checklist.Based on introducing the background,processes of forming CONSORT statement and reviewing the contents and requirements of CONSORT,we prepared this paper,hoping to improving the quality of reporting randomized controlled clinical trials in our country.Some comments and suggestions were given at the same time.