Cluster Randomized Trial Designs in Cancer Care Delivery Research - Resources

Resources

Textbooks

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.

Websites

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/

Readings

  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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.
  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.
  1. 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.
  1. 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.
  1. 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.
  1. 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.
  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.
  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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
  1. 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.
  1. 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.
  1. 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.
  1. 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
  1. 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

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
https://rpubs.com/derek6561/swcrtexample

Planning special SW designs:

Continuous recruitment designs:
https://monash-biostat.shinyapps.io/ContsTimeDecay/

Staircase designs:
https://monash-biostat.shinyapps.io/StaircaseDesign/

SW-CRT with subclusters:
https://kendra-davis-plourde.shinyapps.io/SWCRT_3Level_DesignEffect/

General apps to inform design:

Information content – the impact of different periods, sequences, and cluster-period cells on power
https://monash-biostat.shinyapps.io/informationcontent/

Examining the impact of misspecification of the correlation structure on inferences:
https://monash-biostat.shinyapps.io/MisspecCorrStruct/

Databank of real ICC/CAC values for trials with continuous outcomes:
https://monash-biostat.shinyapps.io/CLOUDbank/