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

CONSORT 2025声明是当前国际上随机试验报告规范的最新版本，于2025年4月由全球顶级医学期刊（BMJ、JAMA、Lancet等）同步发布，该声明旨在提升随机试验报告的透明度、完整性和科学性，使研究结果更具可重复性和现实指导意义。相较于2010版，CONSORT 2025声明对既有条目和表述进行了优化，最显著的变化是新增了7个条目。其中，新增的条目8“患者及公众参与”，正式提出将患者及公众在临床试验全过程中的作用纳入报告的强制性要求。该条目规定，研究者需详细说明患者和（或）公众是在试验设计、实施和（或）报告的哪一个环节，以何种方式参与该项试验。此项变革的根源在于临床研究领域日益强调以患者为中心，将其视为提升试验相关性、现实价值和伦理标准的关键。无论国内还是国外，越来越多的政策及权威指南均将患者及公众参与作为确保临床研究科学性、服务社会健康需求、增强公众信任的基础环节。本文通过综述患者及公众参与的定义、发展历史及在我国的发展情况，对CONSORT 2025声明中的患者及公众参与说明进行深入解读。 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, JAMA, 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.