Group sequential designs for stepped-wedge cluster randomised trials

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Group sequential designs for stepped-wedge cluster randomised trials

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...

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Stepped-wedge cluster randomised trials: where, when and why?

The stepped wedge (SW) cluster randomised trial (CRT) design is being utilised at increasing pace. However, little is known about the standard of reporting of such trials, or how useful the design has proven to be in hindsight. Moreover, much debate exists around when the design should be preferred to the more classical parallel group (PG) CRT. Here, we address these issues by first conducting ...

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Stepped-wedge cluster randomised controlled trials: a generic framework including parallel and multiple-level designs

Stepped-wedge cluster randomised trials (SW-CRTs) are being used with increasing frequency in health service evaluation. Conventionally, these studies are cross-sectional in design with equally spaced steps, with an equal number of clusters randomised at each step and data collected at each and every step. Here we introduce several variations on this design and consider implications for power. ...

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Unequal cluster sizes in stepped-wedge cluster randomised trials: a systematic review

OBJECTIVES To investigate the extent to which cluster sizes vary in stepped-wedge cluster randomised trials (SW-CRT) and whether any variability is accounted for during the sample size calculation and analysis of these trials. SETTING Any, not limited to healthcare settings. PARTICIPANTS Any taking part in an SW-CRT published up to March 2016. PRIMARY AND SECONDARY OUTCOME MEASURES The pr...

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Admissible multi-arm stepped-wedge cluster randomized trial designs

Numerous publications have addressed the principles of designing, analyzing, and reporting, stepped-wedge cluster randomized trials. In contrast, there is little research available pertaining to the design and analysis of multi-arm stepped-wedge cluster randomized trials, applied to evaluate the effectiveness of multiple experimental interventions with a natural ordering. In this paper, we addr...

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ژورنال

عنوان ژورنال: Clinical Trials

سال: 2017

ISSN: 1740-7745,1740-7753

DOI: 10.1177/1740774517716937