2022《美国心脏协会(AHA)心脏外科随机对照试验设计、执行和分析方法学标准的科学声明》解读  

Interpretation of methodological standards for the design, implementation, and analysis of randomized trials in cardiac surgery: A scientific statement from the American Heart Association in 2022

作　　者：朱云鹏[1] 张恒[2] 郑哲[2] 赵强[1] ZHU Yunpeng;ZHANG Heng;ZHENG Zhe;ZHAO Qiang(Department of Cardiovascular Surgery,Ruijin Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai,200025,P.R.China;Fuwai Hospital,National Center for Cardiovascular Diseases,National Clinical Research Center of Cardiovascular Diseases,State Key Laboratory of Cardiovascular Disease,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing,100037,P.R.China)

机构地区：[1]上海交通大学医学院附属瑞金医院心血管外科,上海200025 [2]中国医学科学院,北京协和医学院,国家心血管病中心,国家心血管疾病临床医学研究中心心血管疾病国家重点实验室,阜外医院心血管外科,北京100037

出　　处：《中国胸心血管外科临床杂志》2023年第1期10-16,共7页Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

基　　金：上海市科学技术委员会生物医药重点项目(21Y21901300);上海交通大学医学院附属瑞金医院临床研究中心项目(2018CR001);国家心血管疾病临床医学研究中心自主课题(NCRC2020004)。

摘　　要：心脏外科在开展随机对照试验(RCT)时面临特别的挑战。为此美国心脏协会(AHA)制定了相关方法学标准的科学声明,旨在系统性总结心脏外科RCT设计,实施的核心建议、解读关键概念和标准,并为其提供具体的方法学建议:包括评估研究问题和临床均势,筛选代表性患者入组的可行性,实践差异对试验干预效果的影响,组间交叉的影响以及随访的持续时间。同时建议预先确定试验干预措施和研究终点,并确保试验干预措施的充分实施;尽一切努力保证随访的完整性;根据特定的研究问题和试验环境采用合适的试验设计和分析策略。本文笔者根据实践体会,对此科学声明进行解读。Cardiac surgery presents specific challenges in conducting randomized controlled trials(RCTs). The American Heart Association made a scientific statement of methodological standards, with the purpose to review key concepts and standards in design, implementation, and analysis of cardiac surgery RCTs, and to provide recommendations. Recommendations include an evaluation of the suitability of the research question, clinical equipoise,feasibility of enrolling a representative patient cohort, impact of practice variations on the effect of the study intervention,likelihood and impact of crossover, and duration of follow-up. Trial interventions and study end points should be predefined, and adequate deliverability of the trial interventions should be ensured. Every effort must be made to keep a high completeness of follow-up. Trial design and analytic techniques must be tailored to the specific research question and trial setting. In this paper, the authors made an interpretation of this scientific statement based on their practical experience.

关 键 词：心脏外科 随机对照试验 方法学标准 临床均势 解读 

分 类 号：R654.2[医药卫生—外科学]