ReviewStatistical methods in medical research2021
Mixed-effects models for the design and analysis of stepped wedge cluster randomized trials: An overview.
Review in Statistical methods in medical research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 124 papers.
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.
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.
Who cites it
124 citing papers in PubMed.
- Evaluation of a Novel Electric Health Record Sidecar Application to Display Rheumatoid Arthritis Clinical Outcomes During Clinic Visits: Results of a Stepped-Wedge Cluster Randomized Pragmatic Trial.Arthritis care & research · 2026Trial
- World Health Organization Multimodal Improvement Strategy for Hand Hygiene: A Stepped-Wedge Cluster Randomized Trial.JAMA network open · 2026Trial
- Cardiopulmonary Point-of-Care Ultrasonography for Hospitalist Management of Undifferentiated Dyspnea.JAMA network open · 2025Trial
- Burden and care time for dementia caregivers in the LIVE@Home.Path trial.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025Trial
- Effect of a small increase in off-premises trading hours on alcohol sales in Norway: A stepped-wedge cluster-randomized controlled trial.Addiction (Abingdon, England) · 2025Trial
- Trial
- Trial
- Early Childhood Caries Intervention in Aboriginal Australian Children: A Cross-in Randomized Trial.JDR clinical and translational research · 2024Trial
- Let's TOC Fertility: A stepped wedge cluster randomized controlled trial of the Telehealth Oncofertility Care (TOC) intervention in children, adolescent and young adult cancer survivors.Contemporary clinical trials · 2024Trial
- Care of Injured Children Compared to Adults at District and Regional Hospitals in Ghana and the Impact of a Trauma Intake Form: A Stepped-Wedge Cluster Randomized Trial.Journal of pediatric surgery · 2024Trial
- Differences in trauma care between district and regional hospitals and impact of a trauma intake form with decision support prompts in Ghana: A stepped-wedge cluster randomized trial.World journal of surgery · 2024Trial
- Does it decay? Obtaining decaying correlation parameter values from previously analysed cluster randomised trials.Statistical methods in medical research · 2023Trial
- Standardized trauma intake form with clinical decision support prompts improves care and reduces mortality for seriously injured patients in non-tertiary hospitals in Ghana: stepped-wedge cluster randomized trial.The British journal of surgery · 2023Trial
- Trusted residents and housing assistance to decrease violence exposure in New Haven (TRUE HAVEN): a strengths-based and community-driven stepped-wedge intervention to reduce gun violence.BMC public health · 2023Trial
- The third Intensive Care Bundle with Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT3): an international, stepped wedge cluster randomised controlled trial.Lancet (London, England) · 2023Trial
- Rethinking children's physical activity interventions at school: A new context-specific approach.Frontiers in public health · 2023Trial
- Evaluation of the type I error rate when using parametric bootstrap analysis of a cluster randomized controlled trial with binary outcomes and a small number of clusters.Computer methods and programs in biomedicine · 2022Trial
- Divergent confidence intervals among pre-specified analyses in the HiSTORIC stepped wedge trial: An exploratory post-hoc investigation.PloS one · 2022Trial
- Evaluation of a program for routine implementation of shared decision-making in cancer care: results of a stepped wedge cluster randomized trial.Implementation science : IS · 2021Trial
- Trial
64 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
The stepped wedge cluster randomized design has received increasing attention in pragmatic clinical trials and implementation science research. The key feature of the design is the unidirectional crossover of clusters from the control to intervention conditions on a staggered schedule, which induces confounding of the intervention effect by time. The stepped wedge design first appeared in the Gambia hepatitis study in the 1980s. However, the statistical model used for the design and analysis was not formally introduced until 2007 in an article by Hussey and Hughes. Since then, a variety of mixed-effects model extensions have been proposed for the design and analysis of these trials. In this article, we explore these extensions under a unified perspective. We provide a general model representation and regard various model extensions as alternative ways to characterize the secular trend, intervention effect, as well as sources of heterogeneity. We review the key model ingredients and clarify their implications for the design and analysis. The article serves as an entry point to the evolving statistical literatures on stepped wedge designs.
Indexed as
Identifiers
What OpenQuestion holds
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 OpenQuestion graph.