析因随机试验报告CONSORT 2010扩展声明条目解读  

Interpretation of extension to the consolidated standards of reporting trials(CONSORT)2010 statement for factorial randomized trials

作　　者：王巍巍[1,2,3,4] 朱雪泉 丰雷[1,2] 王刚[1,2] 吴涛 孙凤[3,4] 孙宏玉[5] 唐少文[6] 詹思延[3,4] WANG Weiwei;ZHU Xuequan;FENG Lei;WANG Gang;WU Tao;SUN Feng;SUN Hongyu;TANG Shaowen;ZHAN Siyan(Beijing Key Laboratory of Mental Disorders,National Clinical Research Center for Mental Disorders&National Center for Mental Disorders,Beijing Anding Hospital,Capital Medical University,Beijing 100088,P.R.China;Advanced Innovation Center for Human Brain Protection,Capital Medical University,Beijing 100069,P.R.China;Department of Epidemiology and Biostatistics,School of Public Health,Peking University,Beijing 100191,P.R.China;Key Laboratory of Epidemiology of Major Diseases(Peking University),Ministry of Education,Beijing 100191,P.R.China;School of Nursing,Peking University,Beijing 100191,P.R.China;School of Public Health,Nanjing Medical University,Nanjing 211166,P.R.China)

机构地区：[1]首都医科大学附属北京安定医院,国家精神疾病医学中心,国家精神心理疾病临床医学研究中心,精神疾病诊断与治疗北京市重点实验室,北京100088 [2]首都医科大学人脑保护高精尖创新中心,北京100069 [3]北京大学公共卫生学院流行病与卫生统计学系,北京100191 [4]重大疾病流行病学教育部重点实验室(北京大学),北京100191 [5]北京大学护理学院,北京100191 [6]南京医科大学公共卫生学院,南京211166

出　　处：《中国循证医学杂志》2025年第1期111-117,共7页Chinese Journal of Evidence-based Medicine

基　　金：北京市卫生健康委员会“首都卫生发展科研专项”资助课题项目(编号:首发2024-4-2129、首发2022-4-2125);国家自然科学基金项目(编号:72074011);北京市自然科学基金-海淀原始创新联合基金前沿项目(编号:L222103);北京市教育委员会科研计划一般项目(编号:1230030146);北京市科学技术委员会资助项目(编号:Z221100007422010);中国中医药循证医学中心“业务研究室主任专项”(编号:2020YJSZX-2)。

摘　　要：随机试验报告的透明度对批判性评价和解释研究结果至关重要。析因设计可以在同一个研究中评估2个及以上干预措施,具有全面和高效的方法学优势,在临床试验领域应用广泛。然而目前已发表的析因试验的报告质量堪忧。CONSORT(consolidated standards of reporting trials)工作组在促进健康研究的质量和透明度(EQUATOR)工作组提出的方法学框架基础上,制订了基于共识的析因设计CONSORT 2010扩展声明。该声明修订了CONSORT 2010声明(共37项)中的16个条目,增加了1个新条目,并解释了每个条目重要性,为析因随机试验的报告提供了最低标准参考。本文对该声明进行介绍和解读,为国内学者规范报告析因设计研究提供参考。Transparent reporting of randomized trials is essential to facilitate critical appraisal and interpretation of results.Factorial trials,in which two or more interventions are assessed in the same set of participants,have unique methodological considerations.However,reporting of factorial trials is suboptimal.A consensus-based extension to the consolidated standards of reporting trials(CONSORT)2010 statement for factorial trials was developed based on the enhancing the quality and transparency of health research(EQUATOR)methodological framework.In the study,we introduced and interpreted the extension of the CONSORT 2010 statement for factorial design in which 16 items were modified and one new item was added and presented an example of a factorial trial in mental health to provide guidance on the reporting of factorial randomized trials.

关 键 词：析因设计 报告规范 解读 

分 类 号：R-03[医药卫生]