14.Randomization03.Cluster - sporedata/researchdesigneR GitHub Wiki
- Cluster randomized trials are applicable whenever the intervention applied on a single person is "transmissible" to other individuals. For example, health behavioral interventions are usually spread to others.
- Equipoise, or the belief that there is not enough evidence in relation to a given intervention
- Funding to support the logistics behind the intervention and data collection
- Sites willing to collect the data
- Patients willing to be randomized
- PCORI Standards on Research Designs Using Clusters [1].
- CONSORT extension for cluster randomized trials [2].
- Guidelines for the Content of Statistical Analysis Plans in Clinical Trials [3]
- See packages applicable to group analyses
- Platform trials.
- Stepped-wedge trials which are a special type of cluster randomized trials.
- Books *
- Articles
- Cluster randomized trials [4]
- Treatment effects in multicenter randomized clinical trials [5]
- Common references for randomized designs
[1] PCORI Standards on Research Designs Using Clusters. Posted: November 12, 2015; Updated: February 26, 2019
[2] Hemming K, Taljaard M, McKenzie JE, Hooper R, Copas A, Thompson JA, Dixon-Woods M, Aldcroft A, Doussau A, Grayling M, Kristunas C, Goldstein CE, Campbell MK, Girling A, Eldridge S, Campbell MJ, Lilford RJ, Weijer C, Forbes AB, Grimshaw JM. Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration. BMJ. 2018;363:k1614.
[3] Gamble C, Krishan A, Stocken D, Lewis S, Juszczak E, Doré C, Williamson PR, Altman DG, Montgomery A, Lim P, Berlin J. Guidelines for the Content of Statistical Analysis Plans in Clinical Trials. Jama. 2017 Dec 19;318(23):2337-43.
[4] Meurer WJ, Lewis RJ. Cluster randomized trials. Jama. 2015 May 26;313(20):2068-9.
[5] Senn SJ, Lewis RJ. Treatment effects in multicenter randomized clinical trials. Jama. 2019 Mar 26;321(12):1211-2.