Stepped wedge designs could reduce the required sample size in cluster randomized trials

Journal of Clinical Epidemiology

Volumn 66, Issue 7, 2013, Pages 752-758

  Woertman, Willem ^a   De Hoop, Esther ^a   Moerbeek, Mirjam ^b   Zuidema, Sytse U ^c   Gerritsen, Debby L ^d   Teerenstra, Steven ^a  

^a RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^b UTRECHT UNIVERSITY   (Netherlands)

^c UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^d RADBOUD UNIVERSITY NIJMEGEN   (Netherlands)

Author keywords

ANCOVA; Cluster randomized trial; Design effect; Parallel group design; Sample size; Stepped wedge design

Indexed keywords

ANALYSIS OF COVARIANCE; ARTICLE; CALCULATION; CLUSTER ANALYSIS; CORRELATION ANALYSIS; DEPRESSION; HUMAN; MEASUREMENT; PARALLEL DESIGN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); SAMPLE SIZE; STEPPED WEDGE DESIGN; STUDY DESIGN;

ANALYSIS OF VARIANCE; BINOMIAL DISTRIBUTION; CLUSTER ANALYSIS; COMPUTER SIMULATION; CROSS-OVER STUDIES; DEPRESSION; EPIDEMIOLOGIC RESEARCH DESIGN; HUMANS; MATHEMATICAL COMPUTING; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REPRODUCIBILITY OF RESULTS; SAMPLE SIZE;

EID: 84878219336     PISSN: 08954356     EISSN: 18785921     Source Type: Journal    
DOI: 10.1016/j.jclinepi.2013.01.009     Document Type: Article

References (20)

1. K.F. Schulz, D.G. Altman, and D. Moher CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials J Clin Epidemiol 63 2010 834 840
2. J.M. Bland Cluster randomised trials in the medical literature: two bibliometric surveys BMC Med Res Methodol 4 2004 21
3. A. Donner, and N. Klar Design and analysis of cluster randomization trials in health research 2000 Arnold London, UK
4. ICH E9 Expert Working Group Statistical principles for clinical trials Stat Med 18 1999 1905 1942
5. S. Teerenstra, S. Eldridge, M. Graff, E. de Hoop, and G.F. Borm A simple sample size formula for analysis of covariance in cluster randomized trials Stat Med 31 2012 2169 2178
6. C. Rietbergen, and M. Moerbeek The design of cluster randomized crossover trials J Educ Behav Stat 36 2011 472 490
7. The Gambia Hepatitis intervention study Cancer Res 47 1987 5782 5787
8. M.A. Hussey, and J.P. Hughes Design and analysis of stepped wedge cluster randomized trials Contemp Clin Trials 28 2007 182 191
9. C.A. Brown, and R.J. Lilford The stepped wedge trial design: a systematic review BMC Med Res Methodol 6 2006 54
10. 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
11. D.L. Gerritsen, M. Smalbrugge, S. Teerenstra, R. Leontjevas, E.M. Adang, and M. Vernooij-Dassen Act in case of depression: the evaluation of a care program to improve the detection and treatment of depression in nursing homes. Study Protocol BMC Psychiatry 11 2011 91
12. Z.D. Feng, P. Diehr, A. Peterson, and D. McLerran Selected statistical issues in group randomized trials Annu Rev Public Health 22 2001 167 187
13. T.N. Flynn, E. Whitley, and T.J. Peters Recruitment strategies in a cluster randomized trial - cost implications Stat Med 21 2002 397 405
14. D.M. Murray, S.P. Varnell, and J.L. Blitstein Design and analysis of group-randomized trials: a review of recent methodological developments Am J Public Health 94 2004 423 432
15. 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
16. M.J. Campbell Cluster randomized trials in general (family) practice research Stat Methods Med Res 9 2000 81 94
17. B. Giraudeau, P. Ravaud, and A. Donner Sample size calculation for cluster randomized cross-over trials Stat Med 27 2008 5578 5585
18. G.J. Duncan, and G. Kalton Issues of design and analysis of surveys across time Int Stat Rev 55 1987 97 117
19. H.A. Feldman, and S.M. McKinlay Cohort versus cross-sectional design in large field trials: precision, sample size, and a unifying model Stat Med 13 1994 61 78
20. L. Frison, and S.J. Pocock Repeated measures in clinical-trials - analysis using mean summary statistics and its implications for design Stat Med 11 1992 1685 1704