The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting.
نویسندگان
چکیده
The stepped-wedge cluster randomised trial (SW-CRT) is a novel research study design that is increasingly being used in the evaluation of service delivery type interventions. The SW-CRT is a type of randomised trial in which clusters are randomised to a date at which they initiate the intervention under evaluation. The design involves random and sequential crossover of clusters from control to intervention, until all clusters are exposed.
منابع مشابه
Stepped wedge randomised controlled trials: systematic review of studies
Background: In a stepped wedge, cluster randomised trial, clusters receive the intervention at different time points, and the order in which they received it is randomised. Previous systematic reviews of stepped wedge trials have documented a steady rise in their use between 1987 and 2010, which was attributed to the design’s perceived logistical and analytical advantages. However, the interven...
متن کاملStepped wedge randomised controlled trials: systematic review of studies published between 2010 and 2014
BACKGROUND In a stepped wedge, cluster randomised trial, clusters receive the intervention at different time points, and the order in which they received it is randomised. Previous systematic reviews of stepped wedge trials have documented a steady rise in their use between 1987 and 2010, which was attributed to the design's perceived logistical and analytical advantages. However, the intervent...
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BACKGROUND/AIMS The stepped-wedge cluster randomised trial design has received substantial attention in recent years. Although various extensions to the original design have been proposed, no guidance is available on the design of stepped-wedge cluster randomised trials with interim analyses. In an individually randomised trial setting, group sequential methods can provide notable efficiency ga...
متن کاملWhere should stepped-wedge designs be placed in the evidence hierarchy? Using the “within-wedge” analysis approach to generate evidence of possible bias
The stepped wedge research design is becoming increasingly popular, particularly in the field of implementation science. It is a form of cluster randomised controlled trial with unidirectional cross-over (normally from control to intervention). This trial design may be biased however because the effect of calendar time is unbalanced between control and intervention periods. Hence there is conce...
متن کاملThe optimal design of stepped wedge trials with equal allocation to sequences and a comparison to other trial designs
Background/Aims We sought to optimise the design of stepped wedge trials with an equal allocation of clusters to sequences and explored sample size comparisons with alternative trial designs. Methods We developed a new expression for the design effect for a stepped wedge trial, assuming that observations are equally correlated within clusters and an equal number of observations in each period b...
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ورودعنوان ژورنال:
- BMJ
دوره 350 شماره
صفحات -
تاریخ انتشار 2015