Progress and application of cohort multiple randomized controlled trial: a systematic review_Chinese Journal of Evidence-Based Medicine

Authors：

GUO Yang ¹ , GUO Guanyi ² ,  CAO Xueshan ³

1. Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Cancer Epidemiology, Peking University Cancer Hospital and Institute, Beijing 100142, P.R.China;
2. Department of Haematology, Key Laboratory of Haematology of Hebei Province, The Second Hospital of Hebei Medical University, Shijiazhuang 050000, P.R.China;
3. Department of Molecular and Cellular Physiology, Institute of Medicine, Academic Assembly, Shinshu University, Nagano, 3908621, Japan;

Corresponding author：

CAO Xueshan, Email: cxs_cn@foxmail.com

Keywords：

Cohort multiple randomized controlled trial; Randomized controlled trial (RCT); Pragmatic clinical trial; Systematic review

DOI：

10.7507/1672-2531.201908030

Video：

Export PDF Favorites Scan Get Citation

Abstract Full text Figures/Tables Video References Cited by

Objectives To collect the methodology and original articles on the published cohort multiple randomized controlled trial (cmRCT), and evaluate the development and application of cmRCT.Methods PubMed, EMbase, CNKI, WanFang Data and CBM databases were electronically searched to collect studies on cmRCT from inception to September 2019. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies, then qualitative analysis was conducted.Results A total of 21 studies were enrolled, including 5 original studies and 16 methodology studies. The design of cmRCT was proposed in year 2010 and continuous progress was observed, including aspect of informed consent and statistical analysis, etc. This design has been mainly utilized for chronic diseases (oncology etc.) in Europe; most of these ongoing studies were unpublished. However, to our knowledge, there were none published Chinese original studies or protocols using cmRCT design.Conclusions cmRCT design has been continuously developed and applied since its introduction. This design can be considered in Chinese studies based on Chinese large cohorts to provide more evidence for disease prevention and treatment.

Citation： GUO Yang, GUO Guanyi, CAO Xueshan. Progress and application of cohort multiple randomized controlled trial: a systematic review. Chinese Journal of Evidence-Based Medicine, 2019, 19(12): 1470-1476. doi: 10.7507/1672-2531.201908030 Copy

1.	胡贵平, 胡亚楠, 詹思延. PRECIS 研究进展. 中华流行病学杂志, 2016, 37(3): 439-442.
2.	Jadad A R, Moore R A, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials, 1996, 17(1): 1-12.
3.	Kearns B, Ara R, Young T, et al. Association between body mass index and health-related quality of life, and the impact of self-reported long-term conditions - cross-sectional study from the south Yorkshire cohort dataset. BMC Public Health, 2013, 13: 1009.
4.	Relton C, O'Cathain A, Nicholl J. A pilot 'cohort multiple randomised controlled trial' of treatment by a homeopath for women with menopausal hot flushes. Contemp Clin Trials, 2012, 33(5): 853-859.
5.	Cotterill S, Howells K, Rhodes S, et al. The effect of using social pressure in cover letters to improve retention in a longitudinal health study: an embedded randomised controlled retention trial. Trials, 2017, 18(1): 341.
6.	Viksveen P, Relton C, Nicholl J. Depressed patients treated by homeopaths: a randomised controlled trial using the "cohort multiple randomised controlled trial" (cmRCT) design. Trials, 2017, 18(1): 299.
7.	Williams A, Wiggers J, O?Brien KM, et al. Effectiveness of a healthy lifestyle intervention for chronic low back pain: a randomised controlled trial. Pain, 2018, 159(6): 1137-1146.
8.	Relton C, Torgerson D, O'Cathain A, et al. Rethinking pragmatic randomised controlled trials: introducing the "cohort multiple randomised controlled trial" design. BMJ, 2010, 340: c1066.
9.	Young-Afat DA, Verkooijen HA, van Gils CH, et al. Brief report: staged-informed consent in the cohort multiple randomized controlled trial design. Epidemiology, 2016, 27(3): 389-392.
10.	Relton C. A new design for pragmatic RCTs: a " patient cohort” RCT of treatment by a homeopath for menopausal hot flushes. University of Sheffield, 2009.
11.	Clegg A, Relton C, Young J, et al. Improving recruitment of older people to clinical trials: use of the cohort multiple randomised controlled trial design. Age Ageing, 2015, 44(4): 547-550.
12.	Lambin P, Zindler J, Vanneste B, et al. Modern clinical research: How rapid learning health care and cohort multiple randomised clinical trials complement traditional evidence based medicine. Acta Oncol, 2015, 54(9): 1289-1300.
13.	Viksveen P, Relton C, Nicholl J. Benefits and challenges of using the cohort multiple randomised controlled trial design for testing an intervention for depression. Trials, 2017, 18(1): 308.
14.	van der Velden JM, Verkooijen HM, Young-Afat DA, et al. The cohort multiple randomized controlled trial design: a valid and efficient alternative to pragmatic trials? Int J Epidemiol, 2017, 46(1): 96-102.
15.	Pate A, Candlish J, Sperrin M, et al. Cohort multiple randomised controlled trials (cmRCT) design: efficient but biased? A simulation study to evaluate the feasibility of the Cluster cmRCT design. BMC Med Res Methodol, 2016, 16(1): 109.
16.	Candlish J, Pate A, Sperrin M, et al. Erratum to: Evaluation of biases present in the cohort multiple randomised controlled trial design: a simulation study. BMC Med Res Methodol, 2017, 17(1): 47.
17.	Reeves D, Howells K, Sidaway M, et al. The cohort multiple randomized controlled trial design was found to be highly susceptible to low statistical power and internal validity biases. J Clin Epidemiol, 2018, 95: 111-119.
18.	Groenwold RHH, van Smeden M. Investigation of the "m" in the cmRCT (cohort multiple randomized controlled trial) design revealed dependence between trial results. J Clin Epidemiol, 2018, 101: 119-123.
19.	Relton C, Bissell P, Smith C, et al. South Yorkshire Cohort: a 'cohort trials facility' study of health and weight - protocol for the recruitment phase. BMC Public Health, 2011, 11: 640.
20.	Viksveen P, Relton C. Depression treated by homeopaths: a study protocol for a pragmatic cohort multiple randomised controlled trial. Homeopathy, 2014, 103(2): 147-152.
21.	Kwakkenbos L, Jewett LR, Baron M, et al. The scleroderma patient-centered intervention network (SPIN) cohort: protocol for a cohort multiple randomised controlled trial (cmRCT) design to support trials of psychosocial and rehabilitation interventions in a rare disease context. BMJ Open, 2013, 3(8): pii: e003563.
22.	Cockayne S, Adamson J, Corbacho Martin B, et al. The REFORM study protocol: a cohort randomised controlled trial of a multifaceted podiatry intervention for the prevention of falls in older people. BMJ Open, 2014, 4(12): e006977.
23.	Uher R, Cumby J, MacKenzie LE, et al. A familial risk enriched cohort as a platform for testing early interventions to prevent severe mental illness. BMC Psychiatry, 2014, 14: 344.
24.	Richards DA, Ross S, Robens S, et al. The DiReCT study-improving recruitment into clinical trials: a mixed methods study investigating the ethical acceptability, feasibility and recruitment yield of the cohort multiple randomised controlled trials design. Trials, 2014, 15: 398.
25.	Burbach JP, Verkooijen HM, Intven M, et al. RandomizEd controlled trial for pre-operAtive dose-escaLation BOOST in locally advanced rectal cancer (RECTAL BOOST study): study protocol for a randomized controlled trial. Trials, 2015, 16: 58.
26.	Burbach JP, Kurk SA, Coebergh van den Braak RR, et al. Prospective Dutch colorectal cancer cohort: an infrastructure for long-term observational, prognostic, predictive and (randomized) intervention research. Acta Oncol, 2016, 55(11): 1273-1280.
27.	Couwenberg AM, Burbach MJ, Smits AB, et al. The impact of retractor SPONGE-assisted laparoscopic surgery on duration of hospital stay and postoperative complications in patients with colorectal cancer (SPONGE trial): study protocol for a randomized controlled trial. Trials, 2016, 17(1): 132.
28.	Heaven A, Brown L, Foster M, et al. Keeping it credible in cohort multiple Randomised Controlled Trials: the Community Ageing Research 75+ (CARE 75+) study model of patient and public involvement and engagement. Res Involv Engagem, 2016, 2: 30.
29.	van der Velden JM, Verkooijen HM, Seravalli E, et al. Comparing conVEntional RadioTherapy with stereotactIC body radiotherapy in patients with spinAL metastases: study protocol for an randomized controlled trial following the cohort multiple randomized controlled trial design. BMC Cancer, 2016, 16(1): 909.
30.	Gal R, Monninkhof EM, Groenwold RHH, et al. The effects of exercise on the quality of life of patients with breast cancer (the UMBRELLA Fit study): study protocol for a randomized controlled trial. Trials, 2017, 18(1): 504.
31.	Young-Afat DA, van Gils CH, van den Bongard HJGD, et al. The Utrecht cohort for Multiple BREast cancer intervention studies and Long-term evaLuAtion (UMBRELLA): objectives, design, and baseline results. Breast Cancer Res Treat, 2017, 164(2): 445-450.
32.	Coebergh van den Braak RRJ, van Rijssen LB, van Kleef JJ, et al. Nationwide comprehensive gastro-intestinal cancer cohorts: the 3P initiative. Acta Oncol, 2018, 57(2): 195-202.
33.	Anderson BM, Dutton M, Day E, et al. Frailty Intervention Trial iN End-Stage patientS on haemodialysis (FITNESS): study protocol for a randomised controlled trial. Trials, 2018, 19(1): 457.
34.	Brünahl CA, Klotz SGR, Dybowski C, et al. Combined cognitive-behavioural and physiotherapeutic therapy for patients with chronic pelvic pain syndrome (COMBI-CPPS): study protocol for a controlled feasibility trial. Trials, 2018, 19(1): 20.
35.	Gaziano JM. The evolution of population science: advent of the mega cohort. JAMA, 2010, 304(20): 2288-2289.
36.	Colditz GA, Hankinson SE. The Nurses' Health Study: lifestyle and health among women. Nat Rev Cancer, 2005, 5(5): 388-396.
37.	Tamakoshi A, Ozasa K, Fujino Y, et al. Cohort profile of the Japan Collaborative Cohort Study at final follow-up. J Epidemiol, 2013, 23(3): 227-232.

1. 胡贵平, 胡亚楠, 詹思延. PRECIS 研究进展. 中华流行病学杂志, 2016, 37(3): 439-442.
2. Jadad A R, Moore R A, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials, 1996, 17(1): 1-12.
3. Kearns B, Ara R, Young T, et al. Association between body mass index and health-related quality of life, and the impact of self-reported long-term conditions - cross-sectional study from the south Yorkshire cohort dataset. BMC Public Health, 2013, 13: 1009.
4. Relton C, O'Cathain A, Nicholl J. A pilot 'cohort multiple randomised controlled trial' of treatment by a homeopath for women with menopausal hot flushes. Contemp Clin Trials, 2012, 33(5): 853-859.
5. Cotterill S, Howells K, Rhodes S, et al. The effect of using social pressure in cover letters to improve retention in a longitudinal health study: an embedded randomised controlled retention trial. Trials, 2017, 18(1): 341.
6. Viksveen P, Relton C, Nicholl J. Depressed patients treated by homeopaths: a randomised controlled trial using the "cohort multiple randomised controlled trial" (cmRCT) design. Trials, 2017, 18(1): 299.
7. Williams A, Wiggers J, O?Brien KM, et al. Effectiveness of a healthy lifestyle intervention for chronic low back pain: a randomised controlled trial. Pain, 2018, 159(6): 1137-1146.
8. Relton C, Torgerson D, O'Cathain A, et al. Rethinking pragmatic randomised controlled trials: introducing the "cohort multiple randomised controlled trial" design. BMJ, 2010, 340: c1066.
9. Young-Afat DA, Verkooijen HA, van Gils CH, et al. Brief report: staged-informed consent in the cohort multiple randomized controlled trial design. Epidemiology, 2016, 27(3): 389-392.
10. Relton C. A new design for pragmatic RCTs: a " patient cohort” RCT of treatment by a homeopath for menopausal hot flushes. University of Sheffield, 2009.
11. Clegg A, Relton C, Young J, et al. Improving recruitment of older people to clinical trials: use of the cohort multiple randomised controlled trial design. Age Ageing, 2015, 44(4): 547-550.
12. Lambin P, Zindler J, Vanneste B, et al. Modern clinical research: How rapid learning health care and cohort multiple randomised clinical trials complement traditional evidence based medicine. Acta Oncol, 2015, 54(9): 1289-1300.
13. Viksveen P, Relton C, Nicholl J. Benefits and challenges of using the cohort multiple randomised controlled trial design for testing an intervention for depression. Trials, 2017, 18(1): 308.
14. van der Velden JM, Verkooijen HM, Young-Afat DA, et al. The cohort multiple randomized controlled trial design: a valid and efficient alternative to pragmatic trials? Int J Epidemiol, 2017, 46(1): 96-102.
15. Pate A, Candlish J, Sperrin M, et al. Cohort multiple randomised controlled trials (cmRCT) design: efficient but biased? A simulation study to evaluate the feasibility of the Cluster cmRCT design. BMC Med Res Methodol, 2016, 16(1): 109.
16. Candlish J, Pate A, Sperrin M, et al. Erratum to: Evaluation of biases present in the cohort multiple randomised controlled trial design: a simulation study. BMC Med Res Methodol, 2017, 17(1): 47.
17. Reeves D, Howells K, Sidaway M, et al. The cohort multiple randomized controlled trial design was found to be highly susceptible to low statistical power and internal validity biases. J Clin Epidemiol, 2018, 95: 111-119.
18. Groenwold RHH, van Smeden M. Investigation of the "m" in the cmRCT (cohort multiple randomized controlled trial) design revealed dependence between trial results. J Clin Epidemiol, 2018, 101: 119-123.
19. Relton C, Bissell P, Smith C, et al. South Yorkshire Cohort: a 'cohort trials facility' study of health and weight - protocol for the recruitment phase. BMC Public Health, 2011, 11: 640.
20. Viksveen P, Relton C. Depression treated by homeopaths: a study protocol for a pragmatic cohort multiple randomised controlled trial. Homeopathy, 2014, 103(2): 147-152.
21. Kwakkenbos L, Jewett LR, Baron M, et al. The scleroderma patient-centered intervention network (SPIN) cohort: protocol for a cohort multiple randomised controlled trial (cmRCT) design to support trials of psychosocial and rehabilitation interventions in a rare disease context. BMJ Open, 2013, 3(8): pii: e003563.
22. Cockayne S, Adamson J, Corbacho Martin B, et al. The REFORM study protocol: a cohort randomised controlled trial of a multifaceted podiatry intervention for the prevention of falls in older people. BMJ Open, 2014, 4(12): e006977.
23. Uher R, Cumby J, MacKenzie LE, et al. A familial risk enriched cohort as a platform for testing early interventions to prevent severe mental illness. BMC Psychiatry, 2014, 14: 344.
24. Richards DA, Ross S, Robens S, et al. The DiReCT study-improving recruitment into clinical trials: a mixed methods study investigating the ethical acceptability, feasibility and recruitment yield of the cohort multiple randomised controlled trials design. Trials, 2014, 15: 398.
25. Burbach JP, Verkooijen HM, Intven M, et al. RandomizEd controlled trial for pre-operAtive dose-escaLation BOOST in locally advanced rectal cancer (RECTAL BOOST study): study protocol for a randomized controlled trial. Trials, 2015, 16: 58.
26. Burbach JP, Kurk SA, Coebergh van den Braak RR, et al. Prospective Dutch colorectal cancer cohort: an infrastructure for long-term observational, prognostic, predictive and (randomized) intervention research. Acta Oncol, 2016, 55(11): 1273-1280.
27. Couwenberg AM, Burbach MJ, Smits AB, et al. The impact of retractor SPONGE-assisted laparoscopic surgery on duration of hospital stay and postoperative complications in patients with colorectal cancer (SPONGE trial): study protocol for a randomized controlled trial. Trials, 2016, 17(1): 132.
28. Heaven A, Brown L, Foster M, et al. Keeping it credible in cohort multiple Randomised Controlled Trials: the Community Ageing Research 75+ (CARE 75+) study model of patient and public involvement and engagement. Res Involv Engagem, 2016, 2: 30.
29. van der Velden JM, Verkooijen HM, Seravalli E, et al. Comparing conVEntional RadioTherapy with stereotactIC body radiotherapy in patients with spinAL metastases: study protocol for an randomized controlled trial following the cohort multiple randomized controlled trial design. BMC Cancer, 2016, 16(1): 909.
30. Gal R, Monninkhof EM, Groenwold RHH, et al. The effects of exercise on the quality of life of patients with breast cancer (the UMBRELLA Fit study): study protocol for a randomized controlled trial. Trials, 2017, 18(1): 504.
31. Young-Afat DA, van Gils CH, van den Bongard HJGD, et al. The Utrecht cohort for Multiple BREast cancer intervention studies and Long-term evaLuAtion (UMBRELLA): objectives, design, and baseline results. Breast Cancer Res Treat, 2017, 164(2): 445-450.
32. Coebergh van den Braak RRJ, van Rijssen LB, van Kleef JJ, et al. Nationwide comprehensive gastro-intestinal cancer cohorts: the 3P initiative. Acta Oncol, 2018, 57(2): 195-202.
33. Anderson BM, Dutton M, Day E, et al. Frailty Intervention Trial iN End-Stage patientS on haemodialysis (FITNESS): study protocol for a randomised controlled trial. Trials, 2018, 19(1): 457.
34. Brünahl CA, Klotz SGR, Dybowski C, et al. Combined cognitive-behavioural and physiotherapeutic therapy for patients with chronic pelvic pain syndrome (COMBI-CPPS): study protocol for a controlled feasibility trial. Trials, 2018, 19(1): 20.
35. Gaziano JM. The evolution of population science: advent of the mega cohort. JAMA, 2010, 304(20): 2288-2289.
36. Colditz GA, Hankinson SE. The Nurses' Health Study: lifestyle and health among women. Nat Rev Cancer, 2005, 5(5): 388-396.
37. Tamakoshi A, Ozasa K, Fujino Y, et al. Cohort profile of the Japan Collaborative Cohort Study at final follow-up. J Epidemiol, 2013, 23(3): 227-232.

Chinese Journal of Evidence-Based Medicine

Progress and application of cohort multiple randomized controlled trial: a systematic review

Abstract Full text Figures/Tables Video References Cited by

Previous Article

Next Article

Format

Content