Interpretation of extension to the consolidated standards of reporting trials (CONSORT) 2010 statement for factorial randomized trials_Chinese Journal of Evidence-Based Medicine

Authors：

WANG Weiwei ^1,2,3,4 , ZHU Xuequan ^1,2 , FENG Lei ^1,2 , WANG Gang ^1,2 ,  WU Tao ^3,4 ,  SUN Feng ^3,4 , SUN Hongyu ⁵ , TANG Shaowen ⁶ , ZHAN Siyan ^3,4

1. Beijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders & National Center for Mental Disorders, Beijing Anding Hospital, Capital Medical University, Beijing 100088, P. R. China;
2. Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing 100069, P. R. China;
3. Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, P. R. China;
4. Key Laboratory of Epidemiology of Major Diseases (Peking University), Ministry of Education, Beijing 100191, P. R. China;
5. School of Nursing, Peking University, Beijing 100191, P. R. China;
6. School of Public Health, Nanjing Medical University, Nanjing 211166, P. R. China;

Corresponding author：

WU Tao, Email: twu@bjmu.edu.cn; SUN Feng, Email: sunfeng@bjmu.edu.cn

Keywords：

Factorial trials; Reporting standards; Interpretation

DOI：

10.7507/1672-2531.202403082

Video：

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Transparent reporting of randomized trials is essential to facilitate critical appraisal and interpretation of results. Factorial trials, in which two or more interventions are assessed in the same set of participants, have unique methodological considerations. However, reporting of factorial trials is suboptimal. A consensus-based extension to the consolidated standards of reporting trials (CONSORT) 2010 statement for factorial trials was developed based on the enhancing the quality and transparency of health research (EQUATOR) methodological framework. In the study, we introduced and interpreted the extension of the CONSORT 2010 statement for factorial design in which 16 items were modified and one new item was added and presented an example of a factorial trial in mental health to provide guidance on the reporting of factorial randomized trials.

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2.	Freidlin B, Korn EL. Two-by-two factorial cancer treatment trials: is sufficient attention being paid to possible interactions. J Natl Cancer Inst, 2017, 109(9): djx146.
3.	Montgomery AA, Astin MP, Peters TJ. Reporting of factorial trials of complex interventions in community settings: a systematic review. Trials, 2011, 12: 179.
4.	Byth K, Gebski V. Factorial designs: a graphical aid for choosing study designs accounting for interaction. Clin Trials, 2004, 1(3): 315-325.
5.	Lubsen J, Pocock SJ. Factorial trials in cardiology: pros and cons. Eur Heart J, 1994, 15(5): 585-588.
6.	Chakraborty B, Collins LM, Strecher VJ, et al. Developing multicomponent interventions using fractional factorial designs. Stat Med, 2009, 28(21): 2687-2708.
7.	Dakin H, Gray A. Economic evaluation of factorial randomised controlled trials: challenges, methods and recommendations. Stat Med, 2017, 36(18): 2814-2830.
8.	McClure LA, Coffey CS, Howard G. Monitoring futility in a two-by-two factorial design: the SPS3 experience. Clin Trials, 2013, 10(2): 250-256.
9.	Bria E, Di Maio M, Nisticò C, et al. Factorial design for randomized clinical trials. Ann Oncol, 2006, 17(10): 1607-1608.
10.	Byar DP. Some statistical considerations for design of cancer prevention trials. Prev Med, 1989, 18(5): 688-699.
11.	Kahan BC, Tsui M, Jairath V, et al. Reporting of randomized factorial trials was frequently inadequate. J Clin Epidemiol, 2020, 117: 52-59.
12.	McAlister FA, Straus SE, Sackett DL, et al. Analysis and reporting of factorial trials: a systematic review. JAMA, 2003, 289(19): 2545-2553.
13.	Kahan BC, Morris TP, Goulão B, et al. Estimands for factorial trials. Stat Med, 2022, 41(22): 4299-4310.
14.	Kahan BC, Hall SS, Beller EM, et al. Reporting of factorial randomized trials: extension of the CONSORT 2010 statement. JAMA, 2023, 330(21): 2106-2114.
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16.	王波, 詹思延. 如何撰写高质量的流行病学研究论文第四讲随机平行对照试验报告规范—CONSORT介绍. 中华流行病学杂志, 2006, 27(12): 1086-1088.
17.	Hawkins M, Cheng C, Elsworth GR, et al. Translation method is validity evidence for construct equivalence: analysis of secondary data routinely collected during translations of the Health Literacy Questionnaire (HLQ). BMC Med Res Methodol, 2020, 20(1): 130.
18.	Hopewell S, Clarke M, Moher D, et al. CONSORT for reporting randomised trials in journal and conference abstracts. Lancet, 2008, 371(9609): 281-283.
19.	Hopewell S, Clarke M, Moher D, et al. CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med, 2008, 5(1): e20.
20.	Mdege ND, Brabyn S, Hewitt C, et al. The 2×2 cluster randomized controlled factorial trial design is mainly used for efficiency and to explore intervention interactions: a systematic review. J Clin Epidemiol, 2014, 67(10): 1083-1092.
21.	Montgomery AA, Peters TJ, Little P. Design, analysis and presentation of factorial randomised controlled trials. BMC Med Res Methodol, 2003, 3: 26.
22.	Baker TB, Smith SS, Bolt DM, et al. Implementing clinical research using factorial designs: a primer. Behav Ther, 2017, 48(4): 567-580.
23.	White IR, Choodari-Oskooei B, Sydes MR, et al. Combining factorial and multi-arm multi-stage platform designs to evaluate multiple interventions efficiently. Clin Trials, 2022, 19(4): 432-441.
24.	Curran D, Sylvester RJ, Hoctin Boes G. Sample size estimation in phase Ⅲ cancer clinical trials. Eur J Surg Oncol, 1999, 25(3): 244-250.
25.	Slud EV. Analysis of factorial survival experiments. Biometrics, 1994, 50(1): 25-38.
26.	Tian Z, Esserman D, Tong G, et al. Sample size calculation in hierarchical 2×2 factorial trials with unequal cluster sizes. Stat Med, 2022, 41(4): 645-664.
27.	Kahan BC. Bias in randomised factorial trials. Stat Med, 2013, 32(26): 4540-4549.
28.	Hitsman B, Papandonatos GD, Gollan JK, et al. Efficacy and safety of combination behavioral activation for smoking cessation and varenicline for treating tobacco dependence among individuals with current or past major depressive disorder: a 2×2 factorial, randomized, placebo-controlled trial. Addiction, 2023, 118(9): 1710-1725.

1. Green S, Liu PY, O'Sullivan J. Factorial design considerations. J Clin Oncol, 2002, 20(16): 3424-3430.
2. Freidlin B, Korn EL. Two-by-two factorial cancer treatment trials: is sufficient attention being paid to possible interactions. J Natl Cancer Inst, 2017, 109(9): djx146.
3. Montgomery AA, Astin MP, Peters TJ. Reporting of factorial trials of complex interventions in community settings: a systematic review. Trials, 2011, 12: 179.
4. Byth K, Gebski V. Factorial designs: a graphical aid for choosing study designs accounting for interaction. Clin Trials, 2004, 1(3): 315-325.
5. Lubsen J, Pocock SJ. Factorial trials in cardiology: pros and cons. Eur Heart J, 1994, 15(5): 585-588.
6. Chakraborty B, Collins LM, Strecher VJ, et al. Developing multicomponent interventions using fractional factorial designs. Stat Med, 2009, 28(21): 2687-2708.
7. Dakin H, Gray A. Economic evaluation of factorial randomised controlled trials: challenges, methods and recommendations. Stat Med, 2017, 36(18): 2814-2830.
8. McClure LA, Coffey CS, Howard G. Monitoring futility in a two-by-two factorial design: the SPS3 experience. Clin Trials, 2013, 10(2): 250-256.
9. Bria E, Di Maio M, Nisticò C, et al. Factorial design for randomized clinical trials. Ann Oncol, 2006, 17(10): 1607-1608.
10. Byar DP. Some statistical considerations for design of cancer prevention trials. Prev Med, 1989, 18(5): 688-699.
11. Kahan BC, Tsui M, Jairath V, et al. Reporting of randomized factorial trials was frequently inadequate. J Clin Epidemiol, 2020, 117: 52-59.
12. McAlister FA, Straus SE, Sackett DL, et al. Analysis and reporting of factorial trials: a systematic review. JAMA, 2003, 289(19): 2545-2553.
13. Kahan BC, Morris TP, Goulão B, et al. Estimands for factorial trials. Stat Med, 2022, 41(22): 4299-4310.
14. Kahan BC, Hall SS, Beller EM, et al. Reporting of factorial randomized trials: extension of the CONSORT 2010 statement. JAMA, 2023, 330(21): 2106-2114.
15. Schulz KF, Altman DG, Moher D, 等. CONSORT 2010声明: 报告平行对照随机临床试验指南的更新. 中西医结合学报, 2010, 8(7): 604-612.
16. 王波, 詹思延. 如何撰写高质量的流行病学研究论文第四讲随机平行对照试验报告规范—CONSORT介绍. 中华流行病学杂志, 2006, 27(12): 1086-1088.
17. Hawkins M, Cheng C, Elsworth GR, et al. Translation method is validity evidence for construct equivalence: analysis of secondary data routinely collected during translations of the Health Literacy Questionnaire (HLQ). BMC Med Res Methodol, 2020, 20(1): 130.
18. Hopewell S, Clarke M, Moher D, et al. CONSORT for reporting randomised trials in journal and conference abstracts. Lancet, 2008, 371(9609): 281-283.
19. Hopewell S, Clarke M, Moher D, et al. CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med, 2008, 5(1): e20.
20. Mdege ND, Brabyn S, Hewitt C, et al. The 2×2 cluster randomized controlled factorial trial design is mainly used for efficiency and to explore intervention interactions: a systematic review. J Clin Epidemiol, 2014, 67(10): 1083-1092.
21. Montgomery AA, Peters TJ, Little P. Design, analysis and presentation of factorial randomised controlled trials. BMC Med Res Methodol, 2003, 3: 26.
22. Baker TB, Smith SS, Bolt DM, et al. Implementing clinical research using factorial designs: a primer. Behav Ther, 2017, 48(4): 567-580.
23. White IR, Choodari-Oskooei B, Sydes MR, et al. Combining factorial and multi-arm multi-stage platform designs to evaluate multiple interventions efficiently. Clin Trials, 2022, 19(4): 432-441.
24. Curran D, Sylvester RJ, Hoctin Boes G. Sample size estimation in phase Ⅲ cancer clinical trials. Eur J Surg Oncol, 1999, 25(3): 244-250.
25. Slud EV. Analysis of factorial survival experiments. Biometrics, 1994, 50(1): 25-38.
26. Tian Z, Esserman D, Tong G, et al. Sample size calculation in hierarchical 2×2 factorial trials with unequal cluster sizes. Stat Med, 2022, 41(4): 645-664.
27. Kahan BC. Bias in randomised factorial trials. Stat Med, 2013, 32(26): 4540-4549.
28. Hitsman B, Papandonatos GD, Gollan JK, et al. Efficacy and safety of combination behavioral activation for smoking cessation and varenicline for treating tobacco dependence among individuals with current or past major depressive disorder: a 2×2 factorial, randomized, placebo-controlled trial. Addiction, 2023, 118(9): 1710-1725.

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