ArticleBMC medical research methodology2022
Mind the gap: covariate constrained randomisation can protect against substantial power loss in parallel cluster randomised trials.
Article in BMC medical research methodology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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Who cites it
3 citing papers in PubMed.
- Implementation of optimized kangaroo care for infection prevention and control in neonatal intensive care units (NeoIPC): Protocol for the implementation elements of a multicenter parallel cluster randomized hybrid type 2 implementation-effectiveness study.Implementation science : IS · 2026Article
- Covariate adjustment in cluster randomised trials: a practical guide.BMJ (Clinical research ed.) · 2025Article
- Comparing analytical strategies for balancing site-level characteristics in stepped-wedge cluster randomized trials: a simulation study.BMC medical research methodology · 2023Article
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4 authors.
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Abstract
backgroundCluster randomised trials often randomise a small number of units, putting them at risk of poor balance of covariates across treatment arms. Covariate constrained randomisation aims to reduce this risk by removing the worst balanced allocations from consideration. This is known to provide only a small gain in power over that averaged under simple randomisation and is likely influenced by the number and prognostic effect of the covariates. We investigated the performance of covariate constrained randomisation in comparison to the worst balanced allocations, and considered the impact on the power of the prognostic effect and number of covariates adjusted for in the analysis.
methodsUsing simulation, we examined the Monte Carlo type I error rate and power of cross-sectional, two-arm parallel cluster-randomised trials with a continuous outcome and four binary cluster-level covariates, using either simple or covariate constrained randomisation. Data were analysed using a small sample corrected linear mixed-effects model, adjusted for some or all of the binary covariates. We varied the number of clusters, intra-cluster correlation, number and prognostic effect of covariates balanced in the randomisation and adjusted in the analysis, and the size of the candidate set from which the allocation was selected. For each scenario, 20,000 simulations were conducted.
resultsWhen compared to the worst balanced allocations, covariate constrained randomisation with an adjusted analysis provided gains in power of up to 20 percentage points. Even with analysis-based adjustment for those covariates balanced in the randomisation, the type I error rate was not maintained when the intracluster correlation is very small (0.001). Generally, greater power was achieved when more prognostic covariates are restricted in the randomisation and as the size of the candidate set decreases. However, adjustment for weakly prognostic covariates lead to a loss in power of up to 20 percentage points.
conclusionsWhen compared to the worst balanced allocations, covariate constrained randomisation provides moderate to substantial improvements in power. However, the prognostic effect of the covariates should be carefully considered when selecting them for inclusion in the randomisation.
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