中国卒中杂志2025，Vol.20Issue(5)：630-635,6.DOI:10.3969/j.issn.1673-5765.2025.05.010
CONSORT 2025声明解读:患者及公众参与说明
Interpretation of the CONSORT 2025 Statement:Explanation of Patient and Public Involvement
摘要
Abstract
The CONSORT 2025 statement is the latest international guideline for reporting randomised trials.It was simultaneously released in April 2025 by leading medical journals worldwide,such as BMJ,J AMA,and Lancet.The statement is aiming to enhance the transparency,completeness,and scientific rigor of randomised trial reports,thereby making research findings more reproducible and practically significant.Compared to the 2010 version,CONSORT 2025 not only optimizes existing items and their wording,but also introduces seven new items.Among them,the newly added item 8,"patient and public involvement",formally mandates the reporting of the role of patients and the public throughout the clinical trial process.This item stipulates that researchers must specify at which phases(design,implementation,and/or reporting)of the trial and in what manner patients and/or the public are involved.This revision originates from the increasing emphasis on patient-centered approaches in clinical research,which is regarded as key to enhancing trial relevance,real-world value,and ethical standards.Both domestically and internationally,an increasing number of policies and authoritative guidelines regard patient and public involvement as fundamental to ensuring the scientific rigor of clinical research,meeting public health needs,and strengthening public trust.This article comprehensively reviews the definition and historical development of patient and public involvement,examines its current status in China,and aims to provide an in-depth interpretation of the patient and public involvement requirements in the CONSORT 2025 statement.关键词
试验报告统一标准/随机试验/患者/公众/利益Key words
Consolidated standards of reporting trials/Randomised trial/Patient/Public/Benefit分类
医药卫生引用本文复制引用
李辉,谢雪微..CONSORT 2025声明解读:患者及公众参与说明[J].中国卒中杂志,2025,20(5):630-635,6.基金项目
国家自然科学基金面上项目(82471356) （82471356）
