临床研究结局指标报告指南解读及其对中医药领域研究的意义及启示

Interpretation of the guidelines for reporting outcomes in trials and its significance and insight for research in the area of traditional Chinese medicine

针对临床研究中结局指标报告不完整、不规范的情况,国际上的方法学专家在临床试验方案报告标准(SPIRIT)2013声明和临床试验报告的统一标准(CONSORT)2010声明的基础上,于2022年同步推出了临床试验方案及报告中无论人群和研究类型都应报告的结局指标条目,即SPIRIT-结局指标2022扩展版和CONSORT-结局指标2022扩展版。本文对这两个结局指标报告指南进行了介绍和解读,并指出,对于临床研究者而言,使用结局指标报告指南有助于研究者在制定研究方案及报告研究结果时全面考虑结局指标相关的问题,提高研究设计及报告的质量;对于核心指标集研究而言,结局指标核心五要素的提出对核心指标集研究者提供了结局指标提取和分析的思路,有助于核心指标集研究的规范化;结局指标报告指南中对相关医学术语的解释则一定程度上有助于中医药领域方法学的完善。

To solve the problems such as the incomplete and non-standard reporting outcomes in clinical trials,international methodologists have simultaneously launched guidelines for reporting outcomes in trial protocols and reports in 2022 on the basis of the Standard Protocol Items:Recommendations for Interventional Trials(SPIRIT)2013 and the Consolidated Standards of Reporting Trials(CONSORT)statement 2010.The SPIRIT-Outcomes 2022 extension and CONSORT-Outcomes 2022 extension recommend outcome-specific reporting items should be included prospectively in trial protocols and reports,regardless of trial design or population.This paper introduces and interprets the two guidelines for reporting outcomes,and discusses their significance and enlightenment to the research in the field of traditional Chinese medicine.For example,using the outcome reporting guidelines will help clinical researchers comprehensively consider issues related to outcomes when reporting protocols or results,which may improve the quality of research design and reporting.For core outcome set,the five core elements of outcomes may help researchers extracting and analyzing outcomes,which will standardize research;the explanation of medical terminology in the outcome reporting guidelines will contribute to the improvement of methodology in the field of traditional Chinese medicine.