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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3.	陈新林,李先涛,胡镜清,等.复杂干预的设计和评价方法.辽宁中医药大学学报,2013,14(4):81-83.
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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.	沈敏学,彭真,胡婧璇,等.中国西部地区小学生营养与食品安全教育的整群随机试验效果评价.中华流行病学杂志,2013,34(9):879-883.
22.	杨进,廖和壮,李永红,等.整群随机对照设计在学校伤寒副伤寒综合干预项目中的应用研究.中国学校卫生,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. 陈新林,李先涛,胡镜清,等.复杂干预的设计和评价方法.辽宁中医药大学学报,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:整群随机试验扩展版.中国循证医学杂志,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. 沈敏学,彭真,胡婧璇,等.中国西部地区小学生营养与食品安全教育的整群随机试验效果评价.中华流行病学杂志,2013,34(9):879-883.
22. 杨进,廖和壮,李永红,等.整群随机对照设计在学校伤寒副伤寒综合干预项目中的应用研究.中国学校卫生,2010,24(3):348-349.

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