Campbell, M. J., & Walters, S. J. (2014). How to design, analyse and report cluster randomised trials in medicine and health related research. John Wiley & Sons.
Donner, A., Klar, N. (2010). Design and Analysis of Cluster Randomization Trials in Health Research. United Kingdom: Wiley.
Eldridge, S., & Kerry, S. (2012). A practical guide to cluster randomised trials in health services research. John Wiley & Sons.
Hayes, R. J., & Moulton, L. H. (2017). Cluster Randomised Trials. Chapman and Hall/CRC.
Matthews, J. N. (2006). Introduction to Randomized Controlled Clinical Trials. United Kingdom: CRC Press.
Murray, D. M. (1998). Design and Analysis of Group-randomized Trials. United Kingdom: Oxford University Press.
Cluster Randomized Trials: Facilitating Quality Trials and Methodological Research. Queen Mary University of London. https://clusterrandomisedtrials.qmul.ac.uk/
NIH Pragmatic Trials Collaboratory: Rethinking Clinical Trials®. Section 3: Cluster Randomized Trials: https://rethinkingclinicaltrials.org/chapters/design/experimental-designs-randomization-schemes-top/cluster-randomized-trials/. https://rethinkingclinicaltrials.org/
Pragmatic and Group-Randomized Trials in Public Health and Medicine: Online Course. Office of Disease Prevention, National Institutes of Health. https://prevention.nih.gov/education-training/pragmatic-and-group-randomized-trials-public-health-and-medicine
Research Methods Resources, National Institutes of Health. https://researchmethodsresources.nih.gov/
- Barker, D., P. McElduff, C. D'Este, and M. J. Campbell. "Stepped Wedge Cluster Randomised Trials: A Review of the Statistical Methodology Used and Available." BMC Med Res Methodol 16 (Jun 6 2016): 69. https://dx.doi.org/10.1186/s12874-016-0176-5.
- Borhan, S., A. Papaioannou, J. Ma, J. Adachi, and L. Thabane. "Analysis and Reporting of Stratified Cluster Randomized Trials-a Systematic Survey." Trials 21, no. 1 (Nov 17 2020): 930. https://dx.doi.org/10.1186/s13063-020-04850-w.
- Caille, A., E. Tavernier, M. Taljaard, and S. Desmée. "Methodological Review Showed That Time-to-Event Outcomes Are Often Inadequately Handled in Cluster Randomized Trials." J Clin Epidemiol 134 (Jun 2021): 125-37. https://dx.doi.org/10.1016/j.jclinepi.2021.02.004.
- Caille A, Taljaard M, Le Vilain FA, Le Moigne A, Copas AJ, Tubach F, Dechartres A. Recruitment and implementation challenges were common in stepped-wedge cluster randomized trials: results from a methodological review. Journal of Clinical Epidemiology. In press.
- Chan, C. L., C. Leyrat, and S. M. Eldridge. "Quality of Reporting of Pilot and Feasibility Cluster Randomised Trials: A Systematic Review." BMJ Open 7, no. 11 (Nov 8 2017): e016970. https://dx.doi.org/10.1136/bmjopen-2017-016970.
- Cook, D. J., W. B. Rutherford, D. C. Scales, N. K. J. Adhikari, and B. H. Cuthbertson. "Rationale, Methodological Quality, and Reporting of Cluster-Randomized Controlled Trials in Critical Care Medicine: A Systematic Review." Crit Care Med 49, no. 6 (Jun 1 2021): 977-87. https://dx.doi.org/10.1097/ccm.0000000000004885.
- Eichner, F. A., R. H. H. Groenwold, D. E. Grobbee, and K. Oude Rengerink. "Systematic Review Showed That Stepped-Wedge Cluster Randomized Trials Often Did Not Reach Their Planned Sample Size." J Clin Epidemiol 107 (Mar 2019): 89-100. https://dx.doi.org/10.1016/j.jclinepi.2018.11.013.
- Hemming, K., K. Carroll, J. Thompson, A. Forbes, and M. Taljaard. "Quality of Stepped-Wedge Trial Reporting Can Be Reliably Assessed Using An updated Consort: Crowd-Sourcing Systematic Review." J Clin Epidemiol 107 (Mar 2019): 77-88. https://dx.doi.org/10.1016/j.jclinepi.2018.11.017.
- Jones, B. G., A. J. Streeter, A. Baker, R. Moyeed, and S. Creanor. "Bayesian Statistics in the Design and Analysis of Cluster Randomised Controlled Trials and Their Reporting Quality: A Methodological Systematic Review." Syst Rev 10, no. 1 (Mar 31 2021): 91. https://dx.doi.org/10.1186/s13643-021-01637-1.
- Kristunas, C. A., K. Hemming, H. Eborall, S. Eldridge, and L. J. Gray. "The Current Use of Feasibility Studies in the Assessment of Feasibility for Stepped-Wedge Cluster Randomised Trials: A Systematic Review." BMC Med Res Methodol 19, no. 1 (Jan 10 2019): 12. https://dx.doi.org/10.1186/s12874-019-0658-3.
- Kristunas, C., T. Morris, and L. Gray. "Unequal Cluster Sizes in Stepped-Wedge Cluster Randomised Trials: A Systematic Review." BMJ Open 7, no. 11 (Nov 15 2017): e017151. https://dx.doi.org/10.1136/bmjopen-2017-017151.
- Lung, T., L. Si, R. Hooper, and G. L. Di Tanna. "Health Economic Evaluation Alongside Stepped Wedge Trials: A Methodological Systematic Review." Pharmacoeconomics 39, no. 1 (Jan 2021): 63-80. https://dx.doi.org/10.1007/s40273-020-00963-x.
- Murray, D. M., M. Taljaard, E. L. Turner, and S. M. George. "Essential Ingredients and Innovations in the Design and Analysis of Group-Randomized Trials." Annu Rev Public Health 41 (Apr 2 2020): 1-19. https://dx.doi.org/10.1146/annurev-publhealth-040119-094027.
- Offorha, B. C., S. J. Walters, and R. M. Jacques. "Statistical Analysis of Publicly Funded Cluster Randomised Controlled Trials: A Review of the National Institute for Health Research Journals Library." Trials 23, no. 1 (Feb 4 2022): 115. https://dx.doi.org/10.1186/s13063-022-06025-1.
- O'Hara, L. M., N. Blanco, S. Leekha, K. A. Stafford, G. P. Slobogean, E. Ludeman, and A. D. Harris. "Design, Implementation, and Analysis Considerations for Cluster-Randomized Trials in Infection Control and Hospital Epidemiology: A Systematic Review." Infect Control Hosp Epidemiol 40, no. 6 (Jun 2019): 686-92. https://dx.doi.org/10.1017/ice.2019.48.
- Pérez, M. C., N. Minoyan, V. Ridde, M. P. Sylvestre, and M. Johri. "Comparison of Registered and Published Intervention Fidelity Assessment in Cluster Randomised Trials of Public Health Interventions in Low- and Middle-Income Countries: Systematic Review." Trials 19, no. 1 (Jul 31 2018): 410. https://dx.doi.org/10.1186/s13063-018-2796-z.
- Siebenhofer, A., M. A. Paulitsch, G. Pregartner, A. Berghold, K. Jeitler, C. Muth, and J. Engler. "Cluster-Randomized Controlled Trials Evaluating Complex Interventions in General Practices Are Mostly Ineffective: A Systematic Review." J Clin Epidemiol 94 (Feb 2018): 85-96. https://dx.doi.org/10.1016/j.jclinepi.2017.10.010.
- Starks, M. A., G. D. Sanders, R. R. Coeytaux, I. L. Riley, L. R. Jackson, 2nd, A. M. Brooks, K. L. Thomas, K. R. Choudhury, R. M. Califf, and A. F. Hernandez. "Assessing Heterogeneity of Treatment Effect Analyses in Health-Related Cluster Randomized Trials: A Systematic Review." PLoS One 14, no. 8 (2019): e0219894. https://dx.doi.org/10.1371/journal.pone.0219894.
- Taljaard, M., K. Hemming, L. Shah, B. Giraudeau, J. M. Grimshaw, and C. Weijer. "Inadequacy of Ethical Conduct and Reporting of Stepped Wedge Cluster Randomized Trials: Results from a Systematic Review." Clin Trials 14, no. 4 (Aug 2017): 333-41. https://dx.doi.org/10.1177/1740774517703057.
- Turner, E. L., F. Li, J. A. Gallis, M. Prague, and D. M. Murray. "Review of Recent Methodological Developments in Group-Randomized Trials: Part 1-Design." Am J Public Health 107, no. 6 (Jun 2017): 907-15. https://dx.doi.org/10.2105/ajph.2017.303706.
- Turner, E. L., M. Prague, J. A. Gallis, F. Li, and D. M. Murray. "Review of Recent Methodological Developments in Group-Randomized Trials: Part 2-Analysis." Am J Public Health 107, no. 7 (Jul 2017): 1078-86. https://dx.doi.org/10.2105/ajph.2017.303707
- Turner, E. L., A. C. Platt, J. A. Gallis, K. Tetreault, C. Easter, J. E. McKenzie, S. Nash, A. B. Forbes, and K. Hemming. "Completeness of Reporting and Risks of Overstating Impact in Cluster Randomised Trials: A Systematic Review." Lancet Glob Health 9, no. 8 (Aug 2021): e1163-e68. https://dx.doi.org/10.1016/s2214-109x(21)00200-x.
- Wang, M., Y. Jin, Z. J. Hu, A. Thabane, B. Dennis, O. Gajic-Veljanoski, J. Paul, and L. Thabane. "The Reporting Quality of Abstracts of Stepped Wedge Randomized Trials Is Suboptimal: A Systematic Survey of the Literature." Contemp Clin Trials Commun 8 (Dec 2017): 1-10. https://dx.doi.org/10.1016/j.conctc.2017.08.009.
- Watson, S. I., A. Girling, and K. Hemming. "Design and Analysis of Three-Arm Parallel Cluster Randomized Trials with Small Numbers of Clusters." Stat Med 40, no. 5 (Feb 28 2021): 1133-46. https://dx.doi.org/10.1002/sim.8828.
- Wolfenden, L., Foy, R., Presseau, J., Grimshaw, J.M., Ivers, N.M, Powell, B.J., Taljaard, M., Wiggers, J., Sutherland, R., Nathan, N., Williams, C.M., Kingsland, M., Milat, A., Hodder, R.K., & Yoong, S.L. Designing and Undertaking Randomized Implementation Trials: Guide for Researchers.” BMJ (2021): 372:m3721. doi: https://doi.org/10.1136/bmj.m3721
- Zhan, D., L. Xu, Y. Ouyang, R. Sawatzky, and H. Wong. "Methods for Dealing with Unequal Cluster Sizes in Cluster Randomized Trials: A Scoping Review." PLoS One 16, no. 7 (2021): e0255389. https://dx.doi.org/10.1371/journal.pone.0255389.
Web Resources For Design And Analysis Of Multiple Period Cluster Randomized Trials
Sample size calculation resources:
A shiny app to find a sample size calculator that has the features you need: https://douyang.shinyapps.io/swcrtcalculator/
Main app-based calculators for sample size calculation
- ShinyCRT (RShiny)
- swdpwr (R and RShiny)
- swCRTdesign (R and RShiny):
- crtfastGEEpwr (SAS)
- SWGRT (stand-alone)
Other sample size calculation resources: https://researchmethodsresources.nih.gov/Tools
R and SAS code used to perform the sample size calculation for worked examples in the presentation
Planning special SW designs:
Continuous recruitment designs:
SW-CRT with subclusters:
General apps to inform design:
Information content – the impact of different periods, sequences, and cluster-period cells on power
Examining the impact of misspecification of the correlation structure on inferences:
Databank of real ICC/CAC values for trials with continuous outcomes: