Interpretation of Guidelines for Statistics and Methods in Surgical Randomized Controlled Trials (Part Two): Based on Reports from <i>JAMA Surgery</i>_CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY

Authors：

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

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

Corresponding author：

PENG Wei, Email: pengwei@wchscu.edu.cn

Keywords：

randomized controlled trial; implementation; supervision and management; participant; statistic; manuscript publication

DOI：

10.7507/1007-9424.202409118

Video：

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This article systematically reviews the series of articles on randomized controlled trial (RCT) methodology guidance published in JAMA Surgery between 2022 and 2023. It focuses on providing an overview and guidance on critical aspects such as trial implementation and oversight, participant recruitment, statistical applications, and key points in manuscript publication. The aim is to offer valuable insights and references for surgeons to conduct efficient clinical trials and successfully publish their research findings.

1.	胥月晴, 孔雕, 彭伟, 等. 《外科随机对照试验的统计与方法指南》解读(一): 基于JAMASurgery的报道. 中国普外基础与临床杂志, [2024-12-09]. http: //kns. cnki. net/kcms/detail/51. 1505. R. 20241121. 1542. 032. html.
2.	Kougias P, Kaji AH, Boermeester M. Practical guide to designing a clinical trial in surgery. JAMA Surg, 2022, 157(12): 1152-1153.
3.	Dijkgraaf MGW, Haukoos J, Itani KMF. Practical guide to design choice of randomized clinical trials in surgery. JAMA Surg, 2022, 157(12): 1154-1155.
4.	Newman LA, Schwartz TA, Boermeester M. Practical guide to recruitment of participants for surgical clinical trials. JAMA Surg, 2022, 157(12): 1156-1157.
5.	de Jonge SW, Kaji AH, Itani KMF. Practical guide to statistical considerations in clinical trials in surgery. JAMA Surg, 2023, 158(1): 89-90.
6.	Kim LT, Kaji AH, Salminen P. Practical guide to quality control in surgical trials. JAMA Surg, 2023, 158(1): 91-92.
7.	Fleshman J, Haukoos J, Salminen P. Practical guide to surgical clinical trial implementation, oversight, and regulatory aspects. JAMA Surg, 2023, 158(1): 93-94.
8.	Fong Y, Haukoos J, Zuckerbraun BS. Practical guide to adjuncts to clinical trials in surgery. JAMA Surg, 2023, 158(1): 95-96.
9.	Pawlik TM, Schwartz TA, Itani KMF. Practical guide to ethical considerations in clinical trials in surgery. JAMA Surg, 2023, 158(2): 204-205.
10.	Lazar EL, Schwartz TA, Zuckerbraun BS. Practical guide to budgeting and funding a clinical trial in surgery. JAMA Surg, 2023, 158(2): 206-207.
11.	Winter DC, Haukoos J, Salminen P. Practical guide to clinical trial publication. JAMA Surg, 2023, 158(2): 208-209.
12.	Huang H, Hou Y, Fang H, et al. Unveiling quality of clinical trial in China: from concern to confirmation. Cancer Commun (Lond), 2024, 44(5): 576-579.
13.	Huang GD, Bull J, Johnston McKee K, et al. Clinical trials recruitment planning: a proposed framework from the Clinical Trials Transformation Initiative. Contemp Clin Trials, 2018, 66: 74-79.
14.	Newman LA, Lee CT, Parekh LP, et al. Use of the National Cancer Data Base to develop clinical trials accrual targets that are appropriate for minority ethnicity patients: a report from the American College of Surgeons Oncology Group (ACOSOG) Special Population Committee. Cancer, 2006, 106(1): 188-195.
15.	Stunkel L, Grady C. More than the money: a review of the literature examining healthy volunteer motivations. Contemp Clin Trials, 2011, 32(3): 342-352.
16.	Wang Z, Chen G, Liu X, et al. The motivations, barriers, and sociodemographic characteristics of healthy Chinese volunteers in phase I research. Eur J Clin Pharmacol, 2021, 77(4): 557-568.
17.	梁梦音, 梁嘉恩, 张恩恩, 等. 国内临床试验参与意愿分析及招募启示. 全科护理, 2024, 22(3): 435-438.
18.	Ioannidis JP. Why most published research findings are false. PLoS Med, 2005, 2(8): e124.
19.	Gamble C, Krishan A, Stocken D, et al. Guidelines for the content of statistical analysis plans in Clinical trials. JAMA, 2017, 318(23): 2337-2343.
20.	Chan AW, Tetzlaff JM, Gøtzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ, 2013, 346: e7586.
21.	杨丽虹, 刘少南, 吴大嵘, 等. 最小临床意义差值的概念及其估算方法. 中国循证医学杂志, 2020, 20(11): 1345-1352.
22.	Noordzij M, Tripepi G, Dekker FW, et al. Sample size calculations: basic principles and common pitfalls. Nephrol Dial Transplant, 2010, 25(5): 1388-1393.
23.	Brookes ST, Whitley E, Peters TJ, et al. Subgroup analyses in randomised controlled trials: quantifying the risks of false-positives and false-negatives. Health Technol Assess, 2001, 5(33): 1-56.
24.	Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ, 2010, 340: c869.
25.	Hernán MA, Robins JM. Per-protocol analyses of pragmatic trials. N Engl J Med, 2017, 377(14): 1391-1398.
26.	熊中敏, 郭怀宇, 吴月欣. 缺失数据处理方法研究综述. 计算机工程与应用, 2021, 57(14): 27-38.
27.	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.
28.	McIsaac DI, MacDonald DB, Aucoin SD. Frailty for perioperative clinicians: a narrative review. Anesth Analg, 2020, 130(6): 1450-1460.
29.	Stadler ZK, Come SE. Review of gene-expression profiling and its clinical use in breast cancer. Crit Rev Oncol Hematol, 2009, 69(1): 1-11.
30.	Ignatiadis M, Sledge GW, Jeffrey SS. Liquid biopsy enters the clinic - implementation issues and future challenges. Nat Rev Clin Oncol, 2021, 18(5): 297-312.
31.	Eagleson R, Altamirano-Diaz L, McInnis A, et al. Implementation of clinical research trials using web-based and mobile devices: challenges and solutions. BMC Med Res Methodol, 2017, 17(1): 43.
32.	赵纪春, 曾国军, 王家嵘. 人工智能在血管外科的应用前景. 中国普外基础与临床杂志, 2018, 25(5): 515-518.
33.	Vijayan V, Connolly JP, Condell J, et al. Review of wearable devices and data collection considerations for connected health. Sensors (Basel), 2021, 21(16): 5589.
34.	Julien HM, Eberly LA, Adusumalli S. Telemedicine and the forgotten America. Circulation, 2020, 142(4): 312-314.
35.	张群华. 拥抱互联网医疗和人工智能融合的高光时刻. 中国普外基础与临床杂志, 2020, 27(9): 1049-1051.
36.	Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med, 2013, 158(3): 200-207.
37.	Schulz KF, Altman DG, Moher D, et al. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med, 2010, 152(11): 726-732.
38.	Piaggio G, Elbourne DR, Pocock SJ, et al. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA, 2012, 308(24): 2594-2604.
39.	Campbell MK, Piaggio G, Elbourne DR, et al. Consort 2010 statement: extension to cluster randomised trials. BMJ, 2012, 345: e5661.

1. 胥月晴, 孔雕, 彭伟, 等. 《外科随机对照试验的统计与方法指南》解读(一): 基于JAMASurgery的报道. 中国普外基础与临床杂志, [2024-12-09]. http: //kns. cnki. net/kcms/detail/51. 1505. R. 20241121. 1542. 032. html.
2. Kougias P, Kaji AH, Boermeester M. Practical guide to designing a clinical trial in surgery. JAMA Surg, 2022, 157(12): 1152-1153.
3. Dijkgraaf MGW, Haukoos J, Itani KMF. Practical guide to design choice of randomized clinical trials in surgery. JAMA Surg, 2022, 157(12): 1154-1155.
4. Newman LA, Schwartz TA, Boermeester M. Practical guide to recruitment of participants for surgical clinical trials. JAMA Surg, 2022, 157(12): 1156-1157.
5. de Jonge SW, Kaji AH, Itani KMF. Practical guide to statistical considerations in clinical trials in surgery. JAMA Surg, 2023, 158(1): 89-90.
6. Kim LT, Kaji AH, Salminen P. Practical guide to quality control in surgical trials. JAMA Surg, 2023, 158(1): 91-92.
7. Fleshman J, Haukoos J, Salminen P. Practical guide to surgical clinical trial implementation, oversight, and regulatory aspects. JAMA Surg, 2023, 158(1): 93-94.
8. Fong Y, Haukoos J, Zuckerbraun BS. Practical guide to adjuncts to clinical trials in surgery. JAMA Surg, 2023, 158(1): 95-96.
9. Pawlik TM, Schwartz TA, Itani KMF. Practical guide to ethical considerations in clinical trials in surgery. JAMA Surg, 2023, 158(2): 204-205.
10. Lazar EL, Schwartz TA, Zuckerbraun BS. Practical guide to budgeting and funding a clinical trial in surgery. JAMA Surg, 2023, 158(2): 206-207.
11. Winter DC, Haukoos J, Salminen P. Practical guide to clinical trial publication. JAMA Surg, 2023, 158(2): 208-209.
12. Huang H, Hou Y, Fang H, et al. Unveiling quality of clinical trial in China: from concern to confirmation. Cancer Commun (Lond), 2024, 44(5): 576-579.
13. Huang GD, Bull J, Johnston McKee K, et al. Clinical trials recruitment planning: a proposed framework from the Clinical Trials Transformation Initiative. Contemp Clin Trials, 2018, 66: 74-79.
14. Newman LA, Lee CT, Parekh LP, et al. Use of the National Cancer Data Base to develop clinical trials accrual targets that are appropriate for minority ethnicity patients: a report from the American College of Surgeons Oncology Group (ACOSOG) Special Population Committee. Cancer, 2006, 106(1): 188-195.
15. Stunkel L, Grady C. More than the money: a review of the literature examining healthy volunteer motivations. Contemp Clin Trials, 2011, 32(3): 342-352.
16. Wang Z, Chen G, Liu X, et al. The motivations, barriers, and sociodemographic characteristics of healthy Chinese volunteers in phase I research. Eur J Clin Pharmacol, 2021, 77(4): 557-568.
17. 梁梦音, 梁嘉恩, 张恩恩, 等. 国内临床试验参与意愿分析及招募启示. 全科护理, 2024, 22(3): 435-438.
18. Ioannidis JP. Why most published research findings are false. PLoS Med, 2005, 2(8): e124.
19. Gamble C, Krishan A, Stocken D, et al. Guidelines for the content of statistical analysis plans in Clinical trials. JAMA, 2017, 318(23): 2337-2343.
20. Chan AW, Tetzlaff JM, Gøtzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ, 2013, 346: e7586.
21. 杨丽虹, 刘少南, 吴大嵘, 等. 最小临床意义差值的概念及其估算方法. 中国循证医学杂志, 2020, 20(11): 1345-1352.
22. Noordzij M, Tripepi G, Dekker FW, et al. Sample size calculations: basic principles and common pitfalls. Nephrol Dial Transplant, 2010, 25(5): 1388-1393.
23. Brookes ST, Whitley E, Peters TJ, et al. Subgroup analyses in randomised controlled trials: quantifying the risks of false-positives and false-negatives. Health Technol Assess, 2001, 5(33): 1-56.
24. Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ, 2010, 340: c869.
25. Hernán MA, Robins JM. Per-protocol analyses of pragmatic trials. N Engl J Med, 2017, 377(14): 1391-1398.
26. 熊中敏, 郭怀宇, 吴月欣. 缺失数据处理方法研究综述. 计算机工程与应用, 2021, 57(14): 27-38.
27. 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.
28. McIsaac DI, MacDonald DB, Aucoin SD. Frailty for perioperative clinicians: a narrative review. Anesth Analg, 2020, 130(6): 1450-1460.
29. Stadler ZK, Come SE. Review of gene-expression profiling and its clinical use in breast cancer. Crit Rev Oncol Hematol, 2009, 69(1): 1-11.
30. Ignatiadis M, Sledge GW, Jeffrey SS. Liquid biopsy enters the clinic - implementation issues and future challenges. Nat Rev Clin Oncol, 2021, 18(5): 297-312.
31. Eagleson R, Altamirano-Diaz L, McInnis A, et al. Implementation of clinical research trials using web-based and mobile devices: challenges and solutions. BMC Med Res Methodol, 2017, 17(1): 43.
32. 赵纪春, 曾国军, 王家嵘. 人工智能在血管外科的应用前景. 中国普外基础与临床杂志, 2018, 25(5): 515-518.
33. Vijayan V, Connolly JP, Condell J, et al. Review of wearable devices and data collection considerations for connected health. Sensors (Basel), 2021, 21(16): 5589.
34. Julien HM, Eberly LA, Adusumalli S. Telemedicine and the forgotten America. Circulation, 2020, 142(4): 312-314.
35. 张群华. 拥抱互联网医疗和人工智能融合的高光时刻. 中国普外基础与临床杂志, 2020, 27(9): 1049-1051.
36. Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med, 2013, 158(3): 200-207.
37. Schulz KF, Altman DG, Moher D, et al. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med, 2010, 152(11): 726-732.
38. Piaggio G, Elbourne DR, Pocock SJ, et al. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA, 2012, 308(24): 2594-2604.
39. Campbell MK, Piaggio G, Elbourne DR, et al. Consort 2010 statement: extension to cluster randomised trials. BMJ, 2012, 345: e5661.

CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY

Latest ArticlesInterpretation of Guidelines for Statistics and Methods in Surgical Randomized Controlled Trials (Part Two): Based on Reports from JAMA Surgery

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