Interpretation of <i>JAMA Surgery</i> “Guidelines on statistics and methods for surgical randomized controlled trials”: Part One_CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY

Authors：

XU Yueqing , KONG Diao , PENG Wei , LI Chuan ,  WEN Tianfu.

Division of Liver Surgery, Department of General Surgery, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;

Corresponding author：

WEN Tianfu., Email: wentianfu@scu.edu.cn

Keywords：

randomized controlled trial; design; ethics; quality control; funding support

DOI：

10.7507/1007-9424.202409117

Video：

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To address the persistent challenges in surgical clinical research, we provide a comprehensive analysis of the series of articles on randomized controlled trials (RCTs) methodology guidance published in JAMA Surgery from 2022 to 2023. This section contents focus on critical aspects of RCTs, including trial design, selection criteria, ethical considerations, quality control, and budgeting and funding support. The objective is to enhance the understanding of RCTs among researchers, particularly surgeons, thereby guiding them in conducting high-quality and scientifically robust RCTs.

1.	Ahmed Ali U, van der Sluis PC, Issa Y, et al. Trends in worldwide volume and methodological quality of surgical randomized controlled trials. Ann Surg, 2013, 258(2): 199-207.
2.	Itani KM, McCullough LB. Randomized clinical surgical trials: are they really necessary?. Asian J Surg, 2004, 27(3): 163-168.
3.	Kougias P, Kaji AH, Boermeester M. Practical guide to designing a clinical trial in surgery. JAMA Surg, 2022, 157(12): 1152-1153.
4.	Dijkgraaf MGW, Haukoos J, Itani KMF. Practical guide to design choice of randomized clinical trials in surgery. JAMA Surg, 2022, 157(12): 1154-1155.
5.	Pawlik TM, Schwartz TA, Itani KMF. Practical guide to ethical considerations in clinical trials in surgery. JAMA Surg, 2023, 158(2): 204-205.
6.	Kim LT, Kaji AH, Salminen P. Practical guide to quality control in surgical trials. JAMA Surg, 2023, 158(1): 91-92.
7.	Lazar EL, Schwartz TA, Zuckerbraun BS. Practical guide to budgeting and funding a clinical trial in surgery. JAMA Surg, 2023, 158(2): 206-207.
8.	Rabinstein AA, Brinjikji W, Kallmes DF. Equipoise in clinical trials: Angst and progress. Circ Res, 2016, 119(7): 798-800.
9.	de Boer MT, Klaase JM, Verhoef C, et al. Fibrin sealant for prevention of resection surface-related complications after liver resection: a randomized controlled trial. Ann Surg, 2012, 256(2): 229-234.
10.	王心怡, 龙囿霖, 方可, 等. 复合终点在临床研究中的应用与挑战. 中国循证医学杂志, 2023, 23(12): 1465-1471.
11.	郑波波, 岳育民, 王新, 等. 原发灶切除对比单独化学治疗转移灶不可切除无症状Ⅳ期结直肠癌的远期生存: 整合分析及试验序贯分析. 中国普外基础与临床杂志, 2022, 29(10): 1318-1325.
12.	Paul M, Bishara J, Yahav D, et al. Trimethoprim-sulfamethoxazole versus vancomycin for severe infections caused by meticillin resistant Staphylococcus aureus: randomised controlled trial. BMJ, 2015, 350: h2219. doi: 10.1136/bmj.h2219.
13.	李雪迎. 实验设计方法介绍—平行组设计. 中国介入心脏病学杂志, 2016, 24(2): 95.
14.	Stewart ZA, Wilinska ME, Hartnell S, et al. Closed-loop insulin delivery during pregnancy in women with type 1 diabetes. N Engl J Med, 2016, 375(7): 644-654.
15.	Cook JA, Elders A, Boachie C, et al. A systematic review of the use of an expertise-based randomised controlled trial design. Trials, 2015, 16: 241. doi: 10.1186/s13063-015-0739-5.
16.	Itani KMF, Reda DJ. Clinical trials design in operative and non operative invasive procedures. Springer International Publishing, 2017. doi: 10.1007/978-3-319-53877-8.
17.	Wang Z, Wang X, Shen Y, et al. Effect of a workplace-based multicomponent intervention on hypertension control: A randomized clinical trial. JAMA Cardiol, 2020, 5(5): 567-575.
18.	Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials, 2007, 28(2): 182-191.
19.	Scales DC, Golan E, Pinto R, et al. Improving appropriate neurologic prognostication after cardiac arrest. A stepped wedge cluster randomized controlled trial. Am J Respir Crit Care Med, 2016, 194(9): 1083-1091.
20.	杨祖耀, 詹思延. 阶梯设计在随机对照试验中的应用. 中华流行病学杂志, 2010, 31(1): 92-95.
21.	颜虹, 夏结来, 于莉莉. 临床试验中适应性设计研究进展. 中华预防医学杂志, 2008, 42(z1): 16-25.
22.	Simon R. Optimal two-stage designs for phase Ⅱ clinical trials. Control Clin Trials, 1989, 10(1): 1-10.
23.	王聪, 徐治立. 临床试验安全性均势伦理探讨. 医学与哲学(A), 2018, 39(7): 22-25.
24.	Childers R, Lipsett PA, Pawlik TM. Informed consent and the surgeon. J Am Coll Surg, 2009, 208(4): 627-634.
25.	Bull S, Lindegger GC. Ensuring consent to research is voluntary: how far do we need to go?. Am J Bioeth, 2011, 11(8): 27-29.
26.	Pech C, Cob N, Cejka JT. Understanding institutional review boards: practical guidance to the IRB review process. Nutr Clin Pract, 2007, 22(6): 618-628.
27.	Abbas A, Diaz A, Obeng-Gyasi S, et al. Disparity in clinical trial participation among patients with gastrointestinal cancer. J Am Coll Surg, 2022, 234(4): 589-598.
28.	Little RJ, D'Agostino R, Cohen ML, et al. The prevention and treatment of missing data in clinical trials. N Engl J Med, 2012, 367(14): 1355-1360.
29.	Bhatt DL, Mehta C. Adaptive Designs for Clinical Trials. N Engl J Med, 2016, 375(1): 65-74.
30.	Lilford RJ, Braunholtz DA, Greenhalgh R, et al. Trials and fast changing technologies: the case for tracker studies. BMJ, 2000, 320(7226): 43-46.
31.	Cook JA. The challenges faced in the design, conduct and analysis of surgical randomised controlled trials. Trials, 2009 Feb 6: 10: 9.
32.	Abraham NS, Young JM, Solomon MJ. A systematic review of reasons for nonentry of eligible patients into surgical randomized controlled trials. Surgery, 2006, 139(4): 469-483.
33.	Farrokhyar F, Karanicolas PJ, Thoma A, et al. Randomized controlled trials of surgical interventions. Ann Surg, 2010, 251(3): 409-416.
34.	Gandjour A. Optimal Sample Size Calculation for Clinical Research under a Budget Constraint. Med Decis Making, 2022, 42(4): 417-418.
35.	Higdon J, Topp R. How to develop a budget for a research proposal. West J Nurs Res, 2004, 26(8): 922-929.
36.	Sun V, Dumitra S, Ruel N, et al. Wireless Monitoring Program of Patient-Centered Outcomes and Recovery Before and After Major Abdominal Cancer Surgery. JAMA Surg, 2017, 152(9): 852-859.

1. Ahmed Ali U, van der Sluis PC, Issa Y, et al. Trends in worldwide volume and methodological quality of surgical randomized controlled trials. Ann Surg, 2013, 258(2): 199-207.
2. Itani KM, McCullough LB. Randomized clinical surgical trials: are they really necessary?. Asian J Surg, 2004, 27(3): 163-168.
3. Kougias P, Kaji AH, Boermeester M. Practical guide to designing a clinical trial in surgery. JAMA Surg, 2022, 157(12): 1152-1153.
4. Dijkgraaf MGW, Haukoos J, Itani KMF. Practical guide to design choice of randomized clinical trials in surgery. JAMA Surg, 2022, 157(12): 1154-1155.
5. Pawlik TM, Schwartz TA, Itani KMF. Practical guide to ethical considerations in clinical trials in surgery. JAMA Surg, 2023, 158(2): 204-205.
6. Kim LT, Kaji AH, Salminen P. Practical guide to quality control in surgical trials. JAMA Surg, 2023, 158(1): 91-92.
7. Lazar EL, Schwartz TA, Zuckerbraun BS. Practical guide to budgeting and funding a clinical trial in surgery. JAMA Surg, 2023, 158(2): 206-207.
8. Rabinstein AA, Brinjikji W, Kallmes DF. Equipoise in clinical trials: Angst and progress. Circ Res, 2016, 119(7): 798-800.
9. de Boer MT, Klaase JM, Verhoef C, et al. Fibrin sealant for prevention of resection surface-related complications after liver resection: a randomized controlled trial. Ann Surg, 2012, 256(2): 229-234.
10. 王心怡, 龙囿霖, 方可, 等. 复合终点在临床研究中的应用与挑战. 中国循证医学杂志, 2023, 23(12): 1465-1471.
11. 郑波波, 岳育民, 王新, 等. 原发灶切除对比单独化学治疗转移灶不可切除无症状Ⅳ期结直肠癌的远期生存: 整合分析及试验序贯分析. 中国普外基础与临床杂志, 2022, 29(10): 1318-1325.
12. Paul M, Bishara J, Yahav D, et al. Trimethoprim-sulfamethoxazole versus vancomycin for severe infections caused by meticillin resistant Staphylococcus aureus: randomised controlled trial. BMJ, 2015, 350: h2219. doi: 10.1136/bmj.h2219.
13. 李雪迎. 实验设计方法介绍—平行组设计. 中国介入心脏病学杂志, 2016, 24(2): 95.
14. Stewart ZA, Wilinska ME, Hartnell S, et al. Closed-loop insulin delivery during pregnancy in women with type 1 diabetes. N Engl J Med, 2016, 375(7): 644-654.
15. Cook JA, Elders A, Boachie C, et al. A systematic review of the use of an expertise-based randomised controlled trial design. Trials, 2015, 16: 241. doi: 10.1186/s13063-015-0739-5.
16. Itani KMF, Reda DJ. Clinical trials design in operative and non operative invasive procedures. Springer International Publishing, 2017. doi: 10.1007/978-3-319-53877-8.
17. Wang Z, Wang X, Shen Y, et al. Effect of a workplace-based multicomponent intervention on hypertension control: A randomized clinical trial. JAMA Cardiol, 2020, 5(5): 567-575.
18. Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials, 2007, 28(2): 182-191.
19. Scales DC, Golan E, Pinto R, et al. Improving appropriate neurologic prognostication after cardiac arrest. A stepped wedge cluster randomized controlled trial. Am J Respir Crit Care Med, 2016, 194(9): 1083-1091.
20. 杨祖耀, 詹思延. 阶梯设计在随机对照试验中的应用. 中华流行病学杂志, 2010, 31(1): 92-95.
21. 颜虹, 夏结来, 于莉莉. 临床试验中适应性设计研究进展. 中华预防医学杂志, 2008, 42(z1): 16-25.
22. Simon R. Optimal two-stage designs for phase Ⅱ clinical trials. Control Clin Trials, 1989, 10(1): 1-10.
23. 王聪, 徐治立. 临床试验安全性均势伦理探讨. 医学与哲学(A), 2018, 39(7): 22-25.
24. Childers R, Lipsett PA, Pawlik TM. Informed consent and the surgeon. J Am Coll Surg, 2009, 208(4): 627-634.
25. Bull S, Lindegger GC. Ensuring consent to research is voluntary: how far do we need to go?. Am J Bioeth, 2011, 11(8): 27-29.
26. Pech C, Cob N, Cejka JT. Understanding institutional review boards: practical guidance to the IRB review process. Nutr Clin Pract, 2007, 22(6): 618-628.
27. Abbas A, Diaz A, Obeng-Gyasi S, et al. Disparity in clinical trial participation among patients with gastrointestinal cancer. J Am Coll Surg, 2022, 234(4): 589-598.
28. Little RJ, D'Agostino R, Cohen ML, et al. The prevention and treatment of missing data in clinical trials. N Engl J Med, 2012, 367(14): 1355-1360.
29. Bhatt DL, Mehta C. Adaptive Designs for Clinical Trials. N Engl J Med, 2016, 375(1): 65-74.
30. Lilford RJ, Braunholtz DA, Greenhalgh R, et al. Trials and fast changing technologies: the case for tracker studies. BMJ, 2000, 320(7226): 43-46.
31. Cook JA. The challenges faced in the design, conduct and analysis of surgical randomised controlled trials. Trials, 2009 Feb 6: 10: 9.
32. Abraham NS, Young JM, Solomon MJ. A systematic review of reasons for nonentry of eligible patients into surgical randomized controlled trials. Surgery, 2006, 139(4): 469-483.
33. Farrokhyar F, Karanicolas PJ, Thoma A, et al. Randomized controlled trials of surgical interventions. Ann Surg, 2010, 251(3): 409-416.
34. Gandjour A. Optimal Sample Size Calculation for Clinical Research under a Budget Constraint. Med Decis Making, 2022, 42(4): 417-418.
35. Higdon J, Topp R. How to develop a budget for a research proposal. West J Nurs Res, 2004, 26(8): 922-929.
36. Sun V, Dumitra S, Ruel N, et al. Wireless Monitoring Program of Patient-Centered Outcomes and Recovery Before and After Major Abdominal Cancer Surgery. JAMA Surg, 2017, 152(9): 852-859.

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