4. Preliminary reporting recommendations
• Trial design
– Definition of the cluster
– Cluster size distinguished from cluster size per observation
period
– Length of the steps (observation periods)
– Number of clusters randomised at each step
– Cohort (repeated measures on individuals), cross-sectional
design (different individuals), or mixture (open cohort)
– Schematic representation of the trial design
4
5. Preliminary reporting recommendations
• Sample size justification
– Allowance for clustering
– Allowance for the number of steps
– Allowance for any repeated measures on individuals
– Clear reference to the methods used
5
6. Preliminary reporting recommendations
Hemming K, Haines T, Chilton PJ, Girling A, Lilford R. (2015) The stepped wedge
cluster randomised trial: rationale, design, analysis, and reporting. BMJ 6;350:h391
8. Preliminary reporting recommendations
• Results
– Characteristics of study population reported by those exposed
and unexposed to the intervention
– Time adjusted treatment effect should be reported and
interpreted as the unbiased estimate of the treatment effect
– Schematic representation of the study design
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