Introduction to Cluster Randomized Trials
DOI:
https://doi.org/10.52787/agl.v56i3.668Keywords:
Randomized trials, clusterAbstract
As healthcare professionals, we frequently read studies evaluating new interventions. Traditionally, most of these studies are individually randomized controlled trials, in which individual patients are randomly assigned to a new treatment. However, we may also encounter a different methodological design: the cluster-randomized controlled trial (cRCT). To critically appraise these studies, we need to understand what a cRCT is, why it is used, and whether the appropriate methodology was applied. The purpose of this article is to provide the tools to assess the quality and validity of these trials.
References
-1. Austin PC, Kapral MK, Vyas MV, Fang J, Yu AYX. Using Multilevel Models and Generalized Estimating Equation Models to Account for Clústering in Neurology Clinical Research. Neurology. 2024 Nov 12;103(9):e209947. DOI: 10.1212/WNL.0000000000209947. Epub 2024 Oct 11. PMID: 39393031; PMCID: PMC11469681.
-2. Campbell MK, Elbourne DR, Altman DG; CONSORT group. CONSORT statement: extension to cluster randomised trials. BMJ. 2004 Mar 20;328(7441):702-8. DOI: 10.1136/bmj.328.7441.702. PMID: 15031246; PMCID: PMC381234.
-3. Campbell MJ, Walters SJ. How to Design, Analyse and Report Cluster Randomised Trials in Medicine and Health Related Research. Chichester: John Wiley & Sons; 2014.
-4. Brown AW, Li P, Bohan Brown MM, Kaiser KA, Keith SW, Oakes JM, Allison DB. Best (but oft-forgotten) practices: designing, analyzing, and reporting cluster randomized controlled trials. Am J Clin Nutr. 2015 Aug;102(2):241-8. DOI: 10.3945/ajcn.114.105072. Epub 2015 May 27. PMID: 26016864; PMCID: PMC4515862.
-5. Campbell MK, Piaggio G, Elbourne DR, Altman DG; CONSORT Group. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012 Sep 4;345:e5661. DOI: 10.1136/bmj.e5661. PMID: 22951546.
-6. Billot L, Copas A, Leyrat C, Forbes A, Turner EL. How should a cluster randomized trial be analyzed? J Epidemiol Popul Health. 2024 Feb;72(1):202196. DOI: 10.1016/j.jeph.2024.202196. Epub
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