临床试验报告中的结局报告规范(CONSORT-Outcomes)2022扩展声明解读

Interpretation of guidelines for reporting outcomes in trial reports:the CONSORT-Outcomes 2022 extension

完整、透明、规范地报告一项临床试验的结局,是保障临床试验的实用性、可重复性和透明度,以及降低选择性报告偏倚的关键因素。临床试验报告统一标准(CONSORT)2010声明为临床试验的报告提供了规范指南。2022年12月,JAMA发表了临床试验报告中的结局报告规范(CONSORT-Outcomes)2022扩展声明,旨在对CONSORT 2010声明中关于试验结局、样本量、统计方法以及辅助分析相关条目进行扩充和解释,以进一步完善临床试验报告中的结局报告的标准。本文结合研究实例,对CONSORT-Outcomes扩展声明进行解读,以期为国内学者报告临床研究结果提供规范性参考。

The complete,transparent,and standardized reporting of the outcome of a clinical trial is a key factor in ensuring the practicality,reproducibility,and transparency of the trial,and reducing bias in selective reporting.The consolidated standards of reporting trials(CONSORT)2010 statement provides normative guidelines for reporting clinical trials.In December 2022,JAMA released the guidelines for reporting outcomes in trial reports(CONSORTOutcomes)2022 extension,aiming to explain the entries related to trial outcomes,sample size,statistical methods,and auxiliary analysis in the CONSORT 2010 statement,to further improve the standards for outcome reporting in clinical trial reports.This article combines research examples to interpret the CONSORT-Outcomes 2022 extension,in order to provide normative references for domestic scholars to report clinical research results.