摘要
临床试验研究方案报告指南(SPIRIT)自2013年首次发布以来便在国际范围内获得广泛关注,该指南旨在提升临床试验方案报告的规范化与透明化水平。随着临床试验研究方法的不断发展,SPIRIT工作组于2025年发布了SPIRIT的更新版本SPIRIT 2025。SPIRIT 2025报告规范共包含34个条目,相较于2013版,新增了2个条目、修订了5个条目、合并了2个条目,并删除了3个条目。其核心更新体现在:新增“开放科学”部分:强调试验注册、试验方案与统计分析方案的可及性、数据共享声明及研究成果的传播政策;新增“受试者和公众参与”条目:要求在方案中说明患者或公众在研究设计、实施及报告阶段的参与情况;结构优化:将原有条目重组为五大板块,使逻辑更清晰,并强烈建议使用时间表图来展示试验流程。本文结合一项随机对照试验研究方案,对SPIRIT 2025声明的条目内容进行实例解读,以期为使用该工具的国内研究人员提供参考与便利。
Since its initial publication in 2013,the SPIRIT(Standard Protocol Items:Recommendations for Interventional Trials)guidelines have received widespread international attention.The guidelines aim to enhance the standardization and transparency of clinical trial protocol reporting.With continuous advancements in clinical trial methodologies,the SPIRIT group released an updated version,SPIRIT 2025,in 2025.The SPIRIT 2025 reporting guideline comprises 34 items;compared with the 2013 version,2 items were added,5 were revised,2 were merged,and 3 were deleted.Its core updates are reflected in:the addition of an"open science"section,which emphasizes trial registration,accessibility of the trial protocol and statistical analysis plan,a data sharing statement,and a dissemination policy for research findings;the addition of a"patient and public involvement"item,which requires the protocol to describe the participation of patients or the public in the trial's design,conduct,and reporting phases;structural optimization,which reorganizes the original items into five major sections for clearer logic and strongly recommends the use of a schedule diagram to present the trial timeline.This article provides an illustrative interpretation of the items contained in the SPIRIT 2025 statement using a randomized controlled trial protocol,aiming to offer guidance and convenience for domestic researchers utilizing this tool.
作者
赵文硕
刘明
葛龙
李伦
史纪元
杨丰文
田金徽
薛付忠
高亚
ZHAO Wenshuo;LIU Ming;GE Long;LI Lun;SHI Jiyuan;YANG Fengwen;TIAN Jinhui;XUE Fuzhong;GAO Ya(Department of Medical Data,School of Public Health,Cheeloo College of Medicine,Shandong University,Jinan 250003,P.R.China;National Institute of Health Data Science of China,Jinan 250003,P.R.China;Evidence-Based Medicine Center,School of Basic Medical Sciences,Lanzhou University,Lanzhou 730000,P.R.China;Key Laboratory of Evidence-Based Medicine of Gansu Province,Lanzhou 730000,P.R.China;Department of Health Policy and Management,School of Public Health,Lanzhou University,Lanzhou 730000,P.R.China;Key Laboratory of Evidence Based Medicine of Gansu Province,Lanzhou 730000,P.R.China;Department of General Surgery,The Second Xiangya Hospital,Central South University,Changsha 410011,P.R.China;Clinical Research Center of Hunan Province,Changsha 410011,P.R.China;School of Nursing,Beijing University of Traditional Chinese Medicine,Beijing 100029,P.R.China;Evidence-Based Medicine Center,Tianjin University of Traditional Chinese Medicine,Tianjin 301617,P.R.China;Key Laboratory of Evidence-Based Evaluation of Traditional Chinese Medicine,National Medical Products Administration,Tianjin 301617,P.R.China)
出处
《中国循证医学杂志》
北大核心
2025年第10期1214-1225,共12页
Chinese Journal of Evidence-based Medicine
基金
山东大学齐鲁青年学者项目(编号:202499000161)。
