Evidence map›Paper›PMID 38031417›Full record

ArticleStatistical methods in medical research2024

The staircase cluster randomised trial design: A pragmatic alternative to the stepped wedge.

Kelsey L Grantham, Andrew B Forbes, Richard Hooper, Jessica Kasza

Abstract read
In one paragraph

Article in Statistical methods in medical research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed.

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  18. Designing stepped wedge trials to evaluate physical activity interventions in schools: methodological considerations.The international journal of behavioral nutrition and physical activity · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Kelsey L GranthamSchool of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.ORCID 0000-0002-5288-611X
Andrew B ForbesSchool of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
Richard HooperWolfson Institute of Population Health, Queen Mary University of London, London, UK.
Jessica KaszaSchool of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.ORCID 0000-0002-8940-0136

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This article introduces the 'staircase' design, derived from the zigzag pattern of steps along the diagonal of a stepped wedge design schematic where clusters switch from control to intervention conditions. Unlike a complete stepped wedge design where all participating clusters must collect and provide data for the entire trial duration, clusters in a staircase design are only required to be involved and collect data for a limited number of pre- and post-switch periods. This could alleviate some of the burden on participating clusters, encouraging involvement in the trial and reducing the likelihood of attrition. Staircase designs are already being implemented, although in the absence of a dedicated methodology, approaches to sample size and power calculations have been inconsistent. We provide expressions for the variance of the treatment effect estimator when a linear mixed model for an outcome is assumed for the analysis of staircase designs in order to enable appropriate sample size and power calculations. These include explicit variance expressions for basic staircase designs with one pre- and one post-switch measurement period. We show how the variance of the treatment effect estimator is related to key design parameters and demonstrate power calculations for examples based on a real trial.

Indexed as

Randomized Controlled Trials as TopicResearch DesignCluster AnalysisLinear ModelsProbabilitySample SizeClinical trial designcluster randomised trialincomplete designintracluster correlationsample size

Identifiers

PMID38031417
PMCPMC10863363

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.