Cluster Randomized Trials: Design, Statistical Analysis Methods and Application_Chinese Journal of Evidence-Based Medicine

Authors：

 CHENXin-lin ¹ , MOChuan-wei ¹ , XUQian ¹ , LIUFeng-bin ² , HOUZheng-kun ² , QIUZhen-wen ² ,  LIXian-tao ¹

1. Basic Medical College, Guangzhou University of Chinese Medicine, Guangzhou, 510006, China;
2. The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China;

Corresponding?author：

LIXian-tao, Email: lixiantao@gzucm.edu.cn

Keywords：

Cluster randomized trial; Design; Statistical analysis; Application; Mixed effect model

DOI：

10.7507/1672-2531.20150123

Video：

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Cluster randomized trial (CRT) is one of the most common design for complex intervention. This paper mainly introduced:the definition of CRT, two designs of CRT including the completely randomization and the restricted randomization (such as stratified randomization and matching randomization), and the statistical analysis methods (such as the general statistical analysis and mixed effect model/multi-level model). This paper also introduced how to estimate the sample size of a CRT, how to report a CRT, and how to apply it into a clinical or community study.

Citation： CHENXin-lin, MOChuan-wei, XUQian, LIUFeng-bin, HOUZheng-kun, QIUZhen-wen, LIXian-tao. Cluster Randomized Trials: Design, Statistical Analysis Methods and Application. Chinese Journal of Evidence-Based Medicine, 2015, 15(6): 741-744. doi: 10.7507/1672-2531.20150123 Copy

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13.	Bennett S,Parpia T,Hayes R,et al.Methods for the analysis of incidence rates in cluster randomized trials.Int J Epidemiol,2002,31(4):839-846.
14.	Omar RZ,Thompson SG.Analysis of a cluster randomized trial with binary outcome data using a multi-level model.Stat Med,2000,19(19):2675-2688.
15.	Bellamy SL,Gibberd R,Hancock L,et al.Analysis of dichotomous outcome data for community intervention studies.Stat Methods Med Res,2000,9(2):135-159.
16.	Neuhaus JM.Statistical methods for longitudinal and clustered designs with binary responses.Stat Methods Med Res,1992,1(3):249-273.
17.	Spiegelhalter DJ.Bayesian methods for cluster randomized trials with continuous responses.Stat Med,2001,20(3):435-452.
18.	Turner RM,Omar RZ,Thompson SG.Bayesian methods of analysis for cluster randomized trials with binary outcome data.Stat Med,2001,20(3):453-472.
19.	Elbourne DR,Campbell MK.Extending the CONSORT statement to cluster randomized trials:for discussion.Stat Med,2001,20(3):489-496.
20.	Kennedy C C,Ioannidis G,Thabane L,et al.Successful knowledge translation intervention in long-term care:final results from the vitamin D and osteoporosis study (ViDOS) pilot cluster randomized controlled trial.Trials,2015,16(1):214.
21.	沈敏學,彭真,胡婧璇,等.中國西部地區小學生營養與食品安全教育的整群隨機試驗效果評價.中華流行病學雜志,2013,34(9):879-883.
22.	楊進,廖和壯,李永紅,等.整群隨機對照設計在學校傷寒副傷寒綜合干預項目中的應用研究.中國學校衛生,2010,24(3):348-349.

1. Craig P,Dieppe P,Macintyre S,et al.Developing and evaluating complex interventions:the new Medical Research Council guidance.BMJ,2008,337:a1655.
2. Craig P,Dieppe P,Macintyre S,et al.Developing and evaluating complex interventions:the new Medical Research Council guidance.Int J Nurs Stud,2013,50(5):587-592.
3. 陳新林,李先濤,胡鏡清,等.復雜干預的設計和評價方法.遼寧中醫藥大學學報,2013,14(4):81-83.
4. Campbell MK,Piaggio G,Elbourne DR,et al.Consort 2010 statement:extension to cluster randomised trials.BMJ,2012,345:e5661.
5. Campbell MK,Elbourne DR,Altman DG,et al.CONSORT指南:整群隨機試驗擴展版.中國循證醫學雜志,2006,6(3):451-458.
6. Murray DM,Varnell SP,Blitstein JL.Design and analysis of group-randomized trials:a review of recent methodological developments.Am J Public Health,2004,94(3):423-432.
7. Puffer S,Torgerson D J,Watson J.Cluster randomized controlled trials.J Eval Clin Pract,2005,11(5):479-483.
8. Abdeljaber MH,Monto AS,Tilden RL,et al.The impact of vitamin A supplementation on morbidity:a randomized community intervention trial.Am J Public Health,1991,81(12):1654-1656.
9. Zucker DM,Lakatos E,Webber LS,et al.Statistical design of the Child and Adolescent Trial for Cardiovascular Health (CATCH):implications of cluster randomization.Control Clin Trials,1995,16(2):96-118.
10. Gail MH,Byar DP,Pechacek TF,et al.Aspects of statistical design for the Community Intervention Trial for Smoking Cessation (COMMIT).Control Clin Trials,1992,13(1):6-21.
11. Ukoumunne OC,Gulliford MC,Chinn S,et al.Methods for evaluating area-wide and organisation-based interventions in health and health care:a systematic review.Health Technol Assess,1999,3(5):92.
12. Gail MH,Mark SD,Carroll RJ,et al.On design considerations and randomization-based inference for community intervention trials.Stat Med,1996,15(11):1069-1092.
13. Bennett S,Parpia T,Hayes R,et al.Methods for the analysis of incidence rates in cluster randomized trials.Int J Epidemiol,2002,31(4):839-846.
14. Omar RZ,Thompson SG.Analysis of a cluster randomized trial with binary outcome data using a multi-level model.Stat Med,2000,19(19):2675-2688.
15. Bellamy SL,Gibberd R,Hancock L,et al.Analysis of dichotomous outcome data for community intervention studies.Stat Methods Med Res,2000,9(2):135-159.
16. Neuhaus JM.Statistical methods for longitudinal and clustered designs with binary responses.Stat Methods Med Res,1992,1(3):249-273.
17. Spiegelhalter DJ.Bayesian methods for cluster randomized trials with continuous responses.Stat Med,2001,20(3):435-452.
18. Turner RM,Omar RZ,Thompson SG.Bayesian methods of analysis for cluster randomized trials with binary outcome data.Stat Med,2001,20(3):453-472.
19. Elbourne DR,Campbell MK.Extending the CONSORT statement to cluster randomized trials:for discussion.Stat Med,2001,20(3):489-496.
20. Kennedy C C,Ioannidis G,Thabane L,et al.Successful knowledge translation intervention in long-term care:final results from the vitamin D and osteoporosis study (ViDOS) pilot cluster randomized controlled trial.Trials,2015,16(1):214.
21. 沈敏學,彭真,胡婧璇,等.中國西部地區小學生營養與食品安全教育的整群隨機試驗效果評價.中華流行病學雜志,2013,34(9):879-883.
22. 楊進,廖和壯,李永紅,等.整群隨機對照設計在學校傷寒副傷寒綜合干預項目中的應用研究.中國學校衛生,2010,24(3):348-349.

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