Sample size calculations for stepped wedge and cluster randomised trials: A unified approach

Journal of Clinical Epidemiology

Volumn 69, Issue , 2016, Pages 137-146

  Hemming, Karla ^a   Taljaard, Monica ^b,c  

^a UNIVERSITY OF BIRMINGHAM   (United Kingdom)

^b OTTAWA HOSPITAL RESEARCH INSTITUTE   (Canada)

^c UNIVERSITY OF OTTAWA   (Canada)

Author keywords

Cluster randomized trial; Efficiency; Power; Sample size; Stepped wedge; Study design

Indexed keywords

ARTICLE; CALCULATION; CLUSTER ANALYSIS; CLUSTER RANDOMIZED TRIAL; CORRELATION COEFFICIENT; CROSS-SECTIONAL STUDY; HUMAN; INFORMATION PROCESSING; LINEAR REGRESSION ANALYSIS; METHODOLOGY; PRIORITY JOURNAL; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); SAMPLE SIZE; STATISTICS AND NUMERICAL DATA;

RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; SAMPLE SIZE;

EID: 84952629829     PISSN: 08954356     EISSN: 18785921     Source Type: Journal    
DOI: 10.1016/j.jclinepi.2015.08.015     Document Type: Article

References (31)

1. M.J. Campbell, A. Donner, and N. Klar Developments in cluster randomized trials and statistics in medicine Stat Med 26 2007 2 19
2. M.K. Campbell, G. Piaggio, D.R. Elbourne, and D.G. Altman Consort 2010 statement: extension to cluster randomised trials BMJ 345 2012 e5661
3. S. Teerenstra, S. Eldridge, M. Graff, H.E. de, and G.F. Borm A simple sample size formula for analysis of covariance in cluster randomized trials Stat Med 31 2012 2169 2178
4. C.A. Brown, and R.J. Lilford The stepped wedge trial design: a systematic review BMC Med Res Methodol 6 2006 54
5. N.D. Mdege, M.S. Man, C.A. Taylor Nee Brown, and D.J. Torgerson Systematic review of stepped wedge cluster randomized trials shows that design is particularly used to evaluate interventions during routine implementation J Clin Epidemiol 64 2011 936 948
6. K. Hemming, T.P. Haines, P.J. Chilton, A.J. Girling, and R.J. Lilford The stepped wedge cluster randomised trial: rationale, design, analysis and reporting BMJ 350 2015 h391
7. M.A. Hussey, and J.P. Hughes Design and analysis of stepped wedge cluster randomized trials Contemp Clin Trials 28 2007 182 191
8. J.P. Hughes Stepped wedge design Wiley Encyclopedia of Clinical Trials 2008 John Wiley & Sons, Inc Hoboken 1 8
9. E. Solomon, T. Rees, O.C. Ukoumunne, B. Metcalf, and M. Hillsdon The Devon Active Villages Evaluation (DAVE) trial of a community-level physical activity intervention in rural south-west England: a stepped wedge cluster randomised controlled trial Int J Behav Nutr Phys Act 11 2014 94
10. D. Kotz, M. Spigt, I.C. Arts, R. Crutzen, and W. Viechtbauer Use of the stepped wedge design cannot be recommended: a critical appraisal and comparison with the classic cluster randomized controlled trial design J Clin Epidemiol 65 2012 1249 1252
11. M. Keriel-Gascou, K. Buchet-Poyau, M. Rabilloud, A. Duclos, and C. Colin A stepped wedge cluster randomized trial is preferable for assessing complex health interventions J Clin Epidemiol 67 2014 831 833
12. N.D. Mdege, M.S. Man, C.A. Taylor nee Brown, and D.J. Torgerson There are some circumstances where the stepped-wedge cluster randomized trial is preferable to the alternative: no randomized trial at all. Response to the commentary by Kotz and colleagues J Clin Epidemiol 65 2012 1253 1254
13. K. Hemming, A. Girling, J. Martin, and S.J. Bond Stepped wedge cluster randomized trials are efficient and provide a method of evaluation without which some interventions would not be evaluated J Clin Epidemiol 66 2013 1058 1059
14. C. Rutterford, M. Taljaard, S. Dixon, A. Copas, and S. Eldridge Reporting and methodological quality of sample size calculations in cluster randomised trials could be improved: a review J Clin Epidemiol 68 2015 716 723
15. A. Donner, and N. Klar Design and Analysis of Cluster Randomised Trials in Health Research 2000 Arnold London
16. E. de Hoop, W. Woertman, and S. Teerenstra The stepped wedge cluster randomized trial always requires fewer clusters but not always fewer measurements, that is, participants than a parallel cluster randomized trial in a cross-sectional design. In reply J Clin Epidemiol 66 2013 1428
17. D. Kotz, M. Spigt, I.C. Arts, R. Crutzen, and W. Viechtbauer The stepped wedge design does not inherently have more power than a cluster randomized controlled trial J Clin Epidemiol 66 2013 1059 1060
18. K. Hemming, and A. Girling The efficiency of stepped wedge vs. cluster randomized trials: stepped wedge studies do not always require a smaller sample size J Clin Epidemiol 66 2013 1427 1428
19. W. Viechtbauer, D. Kotz, M. Spigt, I.C. Arts, and R. Crutzen Response to Keriel-Gascou et al.: higher efficiency and other alleged advantages are not inherent to the stepped wedge design J Clin Epidemiol 67 2014 834 836
20. K. Hemming, R.J. Lilford, and A. Girling Stepped-wedge cluster randomised controlled trials: a generic framework including parallel and multiple level designs Stat Med 34 2015 181 196
21. K. Hemming, A.J. Girling, A.J. Sitch, J. Marsh, and R.J. Lilford Sample size calculations for cluster randomised controlled trials with a fixed number of clusters BMC Med Res Methodol 11 2011 102 111
22. D.A. Rhoda, D.M. Murray, R.R. Andridge, M.L. Pennell, and E.M. Hade Studies with staggered starts: multiple baseline designs and group-randomized trials Am J Public Health 101 2011 2164 2169 Erratum in: Am J Public Health. 2014 Mar;104(3):e12
23. K. Hemming, and A. Girling A menu driven facility for sample size for power and detectable difference calculations in stepped wedge randomised trials Stata J 14 2014 363 380
24. W. Woertman, H.E. de, M. Moerbeek, S.U. Zuidema, D.L. Gerritsen, and S. Teerenstra Stepped wedge designs could reduce the required sample size in cluster randomized trials J Clin Epidemiol 66 2013 752 758
25. J.M. Bland Cluster randomised trials in the medical literature: two bibliometric surveys BMC Med Res Methodol 4 2004 21
26. M.K. Campbell, P.M. Fayers, and J.M. Grimshaw Determinants of the intracluster correlation coefficient in cluster randomized trials: the case of implementation research Clin Trials 2 2005 99 107
27. L. Guittet, B. Giraudeau, and P. Ravaud A priori postulated and real power in cluster randomized trials: mind the gap BMC Med Res Methodol 5 2005 25
28. A. Donner An empirical study of cluster randomization Int J Epidemiol 11 1982 283 286
29. Hughes J, Goldenberg RL, Wilfert CM, Valentine M, Mwinga KG, Guay LA, et al. Design of the HIV Prevention Trials Network (HPTN) Protocol 054: a cluster randomized crossover trial to evaluate combined access to Nevirapine in developing countries. Technical Report 195. Washington: University of Washington, Department of Biostatistics; 2003.
30. R. Hooper, and L. Bourke The dog-leg: an alternative to a cross-over design for pragmatic clinical trials in relatively stable populations Int J Epidemiol 43 2014 930 936
31. S. Eldridge, S. Kerry, and D.J. Torgerson Bias in identifying and recruiting participants in cluster randomised trials: what can be done? BMJ 339 2009 b4006