ArticleJournal of clinical epidemiology2023
A scoping review described diversity in methods of randomization and reporting of baseline balance in stepped-wedge cluster randomized trials.
Article in Journal of clinical epidemiology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.
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The trial behind it
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Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Role of recruitment bias in stepped-wedge cluster randomised controlled trials: a systematic review.BMJ open · 2025Pooled it
- Evaluation of injury prevention interventions using the stepped wedge cluster randomised trial design: key considerations.Injury prevention : journal of the International Society for Child and Adolescent Injury Prevention · 2026Article
- Analysis of Stepped-Wedge Cluster Randomized Trials: A Tutorial Using Marginal Models.Statistics in medicine · 2026Article
- Cluster minimal sufficient balance (CMSB): an efficient covariate balancing randomization method for cluster randomized trials.BMC medical research methodology · 2026Article
- Requirements for designing cluster randomised control trials to detect suppression of malaria vector population densities.BMC biology · 2025Article
- Designing Stepped Wedge Cluster Randomized Trials With a Baseline Measurement of the Outcome.Statistics in medicine · 2025Article
- Association between intraoperative electroencephalograph complexity index and postoperative delirium in elderly patients undergoing orthopedic surgery: a prospective cohort study.Journal of anesthesia · 2025Article
- What Is a Stepped-Wedge Cluster Randomized Trial?JAMA internal medicine · 2025Article
- Power calculation for cross-sectional stepped wedge cluster randomized trials with a time-to-event endpoint.Biometrics · 2025Article
- A review of current practice in the design and analysis of extremely small stepped-wedge cluster randomized trials.Clinical trials (London, England) · 2025Review
- Inclusion of unexposed clusters improves the precision of fixed effects analysis of stepped-wedge cluster randomized trials with binary and count outcomes.BMC medical research methodology · 2024Article
- Article
- Maintaining the validity of inference from linear mixed models in stepped-wedge cluster randomized trials under misspecified random-effects structures.Statistical methods in medical research · 2024Article
- Adherence to key recommendations for design and analysis of stepped-wedge cluster randomized trials: A review of trials published 2016-2022.Clinical trials (London, England) · 2024Review
- Comparing analytical strategies for balancing site-level characteristics in stepped-wedge cluster randomized trials: a simulation study.BMC medical research methodology · 2023Article
Corrections and comments
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Authors and funding
12 authors.
Funding
Abstract
objectivesIn stepped-wedge cluster randomized trials (SW-CRTs), clusters are randomized not to treatment and control arms but to sequences dictating the times of crossing from control to intervention conditions. Randomization is an essential feature of this design but application of standard methods to promote and report on balance at baseline is not straightforward. We aimed to describe current methods of randomization and reporting of balance at baseline in SW-CRTs. STUDY DESIGN AND
settingWe used electronic searches to identify primary reports of SW-CRTs published between 2016 and 2022.
resultsAcross 160 identified trials, the median number of clusters randomized was 11 (Q1-Q3: 8-18). Sixty-three (39%) used restricted randomization-most often stratification based on a single cluster-level covariate; 12 (19%) of these adjusted for the covariate(s) in the primary analysis. Overall, 50 (31%) and 134 (84%) reported on balance at baseline on cluster- and individual-level characteristics, respectively. Balance on individual-level characteristics was most often reported by condition in cross-sectional designs and by sequence in cohort designs. Authors reported baseline imbalances in 72 (45%) trials.
conclusionSW-CRTs often randomize a small number of clusters using unrestricted allocation. Investigators need guidance on appropriate methods of randomization and assessment and reporting of balance at baseline.
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