A stepped wedge cluster randomized trial is preferable for assessing complex health interventions

Affiliations

¹ Université de Lyon, 8 avenue Rockefeller, F-69000, Lyon, France; Université Lyon 1, Département de Médecine Générale, 8 avenue Rockefeller, F 69008, Lyon, France; Hospices Civils de Lyon, Pôle Information Médicale - Evaluation - Recherche, 162 avenue Lacassagne, F-69003, Lyon, France. Electronic address: maud.gascou@chu-lyon.fr.
² Hospices Civils de Lyon, Pôle Information Médicale - Evaluation - Recherche, 162 avenue Lacassagne, F-69003, Lyon, France.
³ Université de Lyon, 8 avenue Rockefeller, F-69000, Lyon, France; Hospices Civils de Lyon, Service de Biostatistique, 162 avenue Lacassagne, F-69003, Lyon, France; CNRS, UMR5558, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Université Lyon 1, 43 bd du 11 novembre 1918, F-69622, Villeurbanne, France.
⁴ Université de Lyon, EA 4129 Laboratoire Santé Individu Société, 8 avenue Rockefeller, F-69000, Lyon, France; Hospices Civils de Lyon, Pôle Information Médicale - Evaluation - Recherche, 162 avenue Lacassagne, F-69003, Lyon, France.

Comment

Maud Keriel-Gascou et al. J Clin Epidemiol. 2014 Jul.

. 2014 Jul;67(7):831-3.

doi: 10.1016/j.jclinepi.2014.02.016. Epub 2014 Apr 26.

¹ Université de Lyon, 8 avenue Rockefeller, F-69000, Lyon, France; Université Lyon 1, Département de Médecine Générale, 8 avenue Rockefeller, F 69008, Lyon, France; Hospices Civils de Lyon, Pôle Information Médicale - Evaluation - Recherche, 162 avenue Lacassagne, F-69003, Lyon, France. Electronic address: maud.gascou@chu-lyon.fr.
² Hospices Civils de Lyon, Pôle Information Médicale - Evaluation - Recherche, 162 avenue Lacassagne, F-69003, Lyon, France.
³ Université de Lyon, 8 avenue Rockefeller, F-69000, Lyon, France; Hospices Civils de Lyon, Service de Biostatistique, 162 avenue Lacassagne, F-69003, Lyon, France; CNRS, UMR5558, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Université Lyon 1, 43 bd du 11 novembre 1918, F-69622, Villeurbanne, France.
⁴ Université de Lyon, EA 4129 Laboratoire Santé Individu Société, 8 avenue Rockefeller, F-69000, Lyon, France; Hospices Civils de Lyon, Pôle Information Médicale - Evaluation - Recherche, 162 avenue Lacassagne, F-69003, Lyon, France.

No abstract available

Comment in

Response to Keriel-Gascou et al. Addressing assumptions on the stepped wedge randomized trial design.
Mdege ND, Kanaan M. Mdege ND, et al. J Clin Epidemiol. 2014 Jul;67(7):833-4. doi: 10.1016/j.jclinepi.2014.02.014. Epub 2014 Apr 18. J Clin Epidemiol. 2014. PMID: 24751180 No abstract available.
Response to Keriel-Gascou et al.: higher efficiency and other alleged advantages are not inherent to the stepped wedge design.
Viechtbauer W, Kotz D, Spigt M, Arts IC, Crutzen R. Viechtbauer W, et al. J Clin Epidemiol. 2014 Jul;67(7):834-6. doi: 10.1016/j.jclinepi.2014.02.015. Epub 2014 Apr 29. J Clin Epidemiol. 2014. PMID: 24786595 No abstract available.

Systematic review of stepped wedge cluster randomized trials shows that design is particularly used to evaluate interventions during routine implementation.
Mdege ND, Man MS, Taylor Nee Brown CA, Torgerson DJ. Mdege ND, et al. J Clin Epidemiol. 2011 Sep;64(9):936-48. doi: 10.1016/j.jclinepi.2010.12.003. Epub 2011 Mar 16. J Clin Epidemiol. 2011. PMID: 21411284
Researchers should convince policy makers to perform a classic cluster randomized controlled trial instead of a stepped wedge design when an intervention is rolled out.
Kotz D, Spigt M, Arts IC, Crutzen R, Viechtbauer W. Kotz D, et al. J Clin Epidemiol. 2012 Dec;65(12):1255-6. doi: 10.1016/j.jclinepi.2012.06.016. Epub 2012 Sep 8. J Clin Epidemiol. 2012. PMID: 22964069 No abstract available.
Use of the stepped wedge design cannot be recommended: a critical appraisal and comparison with the classic cluster randomized controlled trial design.
Kotz D, Spigt M, Arts IC, Crutzen R, Viechtbauer W. Kotz D, et al. J Clin Epidemiol. 2012 Dec;65(12):1249-52. doi: 10.1016/j.jclinepi.2012.06.004. Epub 2012 Sep 8. J Clin Epidemiol. 2012. PMID: 22964070 No abstract available.