Systematic review of stepped wedge cluster randomized trials shows that design is particularly used to evaluate interventions during routine implementation

Mdege, Noreen Dadirai; Man, Mei-See; Taylor, Celia A.; Torgerson, David

doi:10.1016/j.jclinepi.2010.12.003

Cited by 362 publications

(405 citation statements)

References 24 publications

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“…The order in which the individuals or clusters receive the intervention is randomized, so that at the end of the entire time period all participants have received the intervention, thereby counteracting challenge 3 (the organization wants to target all employees with an intervention) (24). The stepped-wedge design is particularly suitable if it is considered unethical to withhold the intervention from participants in a control group (25). Additionally, the stepped wedge design allows for improvement of the intervention based on Schelvis et al lessons learned in every subsequent step (which makes it very suitable for effectiveness trials in practice) and thereby eliminates challenge 4 (the organization or the researcher wants to adjust the intervention protocol).…”

Section: Alternative Design In Experimental Researchmentioning

confidence: 99%

Evaluation of occupational health interventions using a randomized controlled trial: challenges and alternative research designs

Schelvis¹,

Hengel²,

Burdorf³

et al. 2015

Scand J Work Environ Health

104

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This overview aims to guide researchers in occupational health in conducting evaluative research. Several appropriate alternatives for the randomized controlled trial design are available and feasible (ie, stepped wedge, propensity scores, instrumental variables, multiple baseline design, interrupted time series, difference-in-difference, and regression discontinuity), which may provide sufficiently strong evidence to guide decisions on implementation of interventions in workplaces.Affiliation:

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Section: Alternative Design In Experimental Researchmentioning

confidence: 99%

Evaluation of occupational health interventions using a randomized controlled trial: challenges and alternative research designs

Schelvis¹,

Hengel²,

Burdorf³

et al. 2015

Scand J Work Environ Health

104

View full text Add to dashboard Cite

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“…This design is fairly new and has been gaining popularity (12), although some still have concerns about its utility (56,57,61,62). In a stepped wedge design, the intervention is implemented sequentially in all clusters.…”

Section: Stepped Wedge Designmentioning

confidence: 99%

Evaluation of Systems-Oriented Public Health Interventions: Alternative Research Designs

Sanson‐Fisher

DʼEste

Carey

et al. 2014

Annu. Rev. Public Health

123

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Keywordscluster randomized controlled trial, stepped wedge design, interrupted time series, multiple baseline design, controlled prepost design AbstractThe need to provide sound evidence of the costs and benefits of real-world public health interventions has driven advances in the development and analysis of designs other than the controlled trial in which individuals are randomized to an experimental condition. Attention to methodological quality is of critical importance to ensure that any evaluation can accurately answer three fundamental questions: (a) Has a change occurred, (b) did the change occur as a result of the intervention, and (c) is the degree of change significant? A range of alternatives to the individual randomized controlled trial (RCT) can be used for evaluating such interventions, including the cluster RCT, stepped wedge design, interrupted time series, multiple baseline, and controlled prepost designs. The key features and complexities associated with each of these designs are explored.

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“…Undeniably, there has been a growing interest in the design, and in particular, it has now become associated with scenarios in which there is a belief that the trial's experimental intervention will be effective (Brown & Lilford, 2006; Mdege, Man, Taylor (nee Brown), & Torgerson, 2011). Given this commonly held belief, it may come as a surprise that a recent literature review determined that in 31% of the SW‐CRTs completed by February 2015, there was no significant effect of the experimental intervention on any of the trials primary outcome measures (Grayling, Wason, & Mander, 2017a).…”

Section: Introductionmentioning

confidence: 99%

Blinded and unblinded sample size reestimation procedures for stepped‐wedge cluster randomized trials

2018

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The ability to accurately estimate the sample size required by a stepped‐wedge (SW) cluster randomized trial (CRT) routinely depends upon the specification of several nuisance parameters. If these parameters are misspecified, the trial could be overpowered, leading to increased cost, or underpowered, enhancing the likelihood of a false negative. We address this issue here for cross‐sectional SW‐CRTs, analyzed with a particular linear‐mixed model, by proposing methods for blinded and unblinded sample size reestimation (SSRE). First, blinded estimators for the variance parameters of a SW‐CRT analyzed using the Hussey and Hughes model are derived. Following this, procedures for blinded and unblinded SSRE after any time period in a SW‐CRT are detailed. The performance of these procedures is then examined and contrasted using two example trial design scenarios. We find that if the two key variance parameters were underspecified by 50%, the SSRE procedures were able to increase power over the conventional SW‐CRT design by up to 41%, resulting in an empirical power above the desired level. Thus, though there are practical issues to consider, the performance of the procedures means researchers should consider incorporating SSRE in to future SW‐CRTs.

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Systematic review of stepped wedge cluster randomized trials shows that design is particularly used to evaluate interventions during routine implementation

Cited by 362 publications

References 24 publications

Evaluation of occupational health interventions using a randomized controlled trial: challenges and alternative research designs

Evaluation of occupational health interventions using a randomized controlled trial: challenges and alternative research designs

Evaluation of Systems-Oriented Public Health Interventions: Alternative Research Designs

Blinded and unblinded sample size reestimation procedures for stepped‐wedge cluster randomized trials

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