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

Yunpeng ZHU; Heng ZHANG; Zhe ZHENG; Qiang ZHAO

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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

VernacularTitle: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
Author: Yunpeng ZHU ¹ ; Heng ZHANG ² ; Zhe ZHENG ² ; Qiang ZHAO ¹
Author Information

1. Department of Cardiovascular Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, P. R. China
2. 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
Publication Type:Journal Article
Keywords: Cardiac surgery; randomized controlled trials; methodological standard; clinical equipoise
From: Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2023;30(01):10-16
CountryChina
Language:Chinese
Abstract: 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.