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_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

ZHU Yunpeng ¹ , ZHANG Heng ² ,  ZHENG Zhe ² ,  ZHAO Qiang ¹

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;

Corresponding author：

ZHENG Zhe, Email: zhengzhe@fuwai.com; ZHAO Qiang, Email: zq11607@rjh.com.cn

Keywords：

Cardiac surgery; randomized controlled trials; methodological standard; clinical equipoise; interpretation

DOI：

10.7507/1007-4848.202211094

Video：

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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.

Citation： ZHU Yunpeng, ZHANG Heng, ZHENG Zhe, ZHAO Qiang. 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. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2023, 30(1): 10-16. doi: 10.7507/1007-4848.202211094 Copy

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8.	Popma JJ, Deeb GM, Yakubov SJ, et al. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med, 2019, 380(18): 1706-1715.
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13.	Redfors B, Gregson J, Crowley A, et al. The win ratio approach for composite endpoints: Practical guidance based on previous experience. Eur Heart J, 2020, 41(46): 4391-4399.
14.	Hadorn DC, Baker D, Hodges JS, et al. Rating the quality of evidence for clinical practice guidelines. J Clin Epidemiol, 1996, 49(7): 749-754.
15.	Bamat NA, Ekhaguere OA, Zhang L, et al. Protocol adherence rates in superiority and noninferiority randomized clinical trials published in high impact medical journals. Clin Trials, 2020, 17(5): 552-559.
16.	Rothwell PM. External validity of randomised controlled trials: "To whom do the results of this trial apply"? Lancet, 2005, 365(9453): 82-93.
17.	Ford I, Norrie J. Pragmatic trials. N Engl J Med, 2016, 375(5): 454-463.
18.	Matilde Sanchez M, Chen X. Choosing the analysis population in non-inferiority studies: Per protocol or intent-to-treat. Stat Med, 2006, 25(7): 1169-1181.

1. Gaudino M, Kappetein AP, Di Franco A, et al. Randomized trials in cardiac surgery: JACC review topic of the week. J Am Coll Cardiol, 2020, 75(13): 1593-1604.
2. Gaudino M, Chikwe J, Bagiella E, et al. Challenges to randomized trials in adult and congenital cardiac and thoracic surgery. Ann Thorac Surg, 2022, 113(5): 1409-1418.
3. Gaudino M, Chikwe J, Bagiella E, et al. Methodological standards for the design, implementation, and analysis of randomized trials in cardiac surgery: A scientific statement from the American Heart Association. Circulation, 2022, 145(4): e129-e142.
4. Solomon MJ, McLeod RS. Should we be performing more randomized con- trolled trials evaluating surgical operations? Surg, 1995, 118(3): 459-467.
5. Freedman B. Equipoise and the ethics of clinical research. N Engl J Med, 1987, 317(3): 141-145.
6. Taggart DP, Altman DG, Gray AM, et al. Randomized trial of bilateral versus single internal-thoracic-artery grafts. N Engl J Med, 2016, 375(26): 2540-2549.
7. Bagiella E. Randomized trial of hybrid coronary revascularization versus percutaneous coronary intervention. Accessed June 22, 2021. https:// clinicaltrials.gov/ct2/show/NCT03089398.
8. Popma JJ, Deeb GM, Yakubov SJ, et al. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med, 2019, 380(18): 1706-1715.
9. Asgar AW, Khairy P. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med, 2011, 365(1): 90-91.
10. Loop FD, Lytle BW, Cosgrove DM, et al. Influence of the internal-mammary-artery graft on 10-year survival and other cardiac events. N Engl J Med, 1986, 314(1): 1-6.
11. Lamy A, Devereaux PJ, Prabhakaran D, et al. Five-year outcomes after off-pump or on-pump coronary-artery bypass grafting. N Engl J Med, 2016, 375(24): 2359-2368.
12. Stone GW, Adams DH, Abraham WT, et al. Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: Part 2: Endpoint definitions: A consensus document from the Mitral Valve Academic Research Consortium. Eur Heart J, 2015, 36(29): 1878-1891.
13. Redfors B, Gregson J, Crowley A, et al. The win ratio approach for composite endpoints: Practical guidance based on previous experience. Eur Heart J, 2020, 41(46): 4391-4399.
14. Hadorn DC, Baker D, Hodges JS, et al. Rating the quality of evidence for clinical practice guidelines. J Clin Epidemiol, 1996, 49(7): 749-754.
15. Bamat NA, Ekhaguere OA, Zhang L, et al. Protocol adherence rates in superiority and noninferiority randomized clinical trials published in high impact medical journals. Clin Trials, 2020, 17(5): 552-559.
16. Rothwell PM. External validity of randomised controlled trials: "To whom do the results of this trial apply"? Lancet, 2005, 365(9453): 82-93.
17. Ford I, Norrie J. Pragmatic trials. N Engl J Med, 2016, 375(5): 454-463.
18. Matilde Sanchez M, Chen X. Choosing the analysis population in non-inferiority studies: Per protocol or intent-to-treat. Stat Med, 2006, 25(7): 1169-1181.

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

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

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