ArticleBiometrics2024
How to achieve model-robust inference in stepped wedge trials with model-based methods?
Article in Biometrics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
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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.
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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.
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Who cites it
14 citing papers in PubMed.
- Nudging implementation of low tidal volume ventilation: a stepped wedge, cluster randomized trial.Implementation science : IS · 2026Trial
- CRT-Estimands Framework: consensus based extension of the ICH E9(R1) addendum for cluster randomised trials.BMJ (Clinical research ed.) · 2026Article
- Model-robust standardization in stepped wedge cluster randomized trials.Journal of the Royal Statistical Society. Series A, (Statistics in Society) · 2026Article
- Analysis of Stepped-Wedge Cluster Randomized Trials: A Tutorial Using Marginal Models.Statistics in medicine · 2026Article
- Factors affecting power in stepped wedge trials when the treatment effect varies with time.Trials · 2026Article
- A sensitivity analysis approach to principal stratification with a continuous longitudinal intermediate outcome: applications to a cohort stepped wedge trial.Biostatistics (Oxford, England) · 2026Article
- What scientific inferences can be made with randomized implementation rollout trials.Implementation science : IS · 2025Article
- Selecting the optimal longitudinal cluster randomized design with a continuous outcome: Parallel-arm, crossover, or stepped-wedge.Statistical methods in medical research · 2025Article
- Designing Stepped Wedge Cluster Randomized Trials With a Baseline Measurement of the Outcome.Statistics in medicine · 2025Article
- Analysis of Stepped-Wedge Cluster Randomized Trials When Treatment Effects Vary by Exposure Time or Calendar Time.Statistics in medicine · 2025Article
- How Should Parallel Cluster Randomized Trials With a Baseline Period be Analyzed?-A Survey of Estimands and Common Estimators.Biometrical journal. Biometrische Zeitschrift · 2025Article
- What Is a Stepped-Wedge Cluster Randomized Trial?JAMA internal medicine · 2025Article
- Analysis of Cohort Stepped Wedge Cluster-Randomized Trials With Nonignorable Dropout via Joint Modeling.Statistics in medicine · 2025Article
- Demystifying estimands in cluster-randomised trials.Statistical methods in medical research · 2024Article
Corrections and comments
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Authors and funding
3 authors.
Funding
Abstract
A stepped wedge design is an unidirectional crossover design where clusters are randomized to distinct treatment sequences. While model-based analysis of stepped wedge designs is a standard practice to evaluate treatment effects accounting for clustering and adjusting for covariates, their properties under misspecification have not been systematically explored. In this article, we focus on model-based methods, including linear mixed models and generalized estimating equations with an independence, simple exchangeable, or nested exchangeable working correlation structure. We study when a potentially misspecified working model can offer consistent estimation of the marginal treatment effect estimands, which are defined nonparametrically with potential outcomes and may be functions of calendar time and/or exposure time. We prove a central result that consistency for nonparametric estimands usually requires a correctly specified treatment effect structure, but generally not the remaining aspects of the working model (functional form of covariates, random effects, and error distribution), and valid inference is obtained via the sandwich variance estimator. Furthermore, an additional g-computation step is required to achieve model-robust inference under non-identity link functions or for ratio estimands. The theoretical results are illustrated via several simulation experiments and re-analysis of a completed stepped wedge cluster randomized trial.
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Registered trials
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 Socratic graph.