Cluster-level analysis in three-level cluster randomised trials with multi-level covariate-dependent missingness

Community-based public health interventions often use three-level cluster randomised trials (CRTs), for example, individuals are nested within households which are again nested within communities. In these trials, outcome missingness commonly depends on baseline covariates measured at multiple levels. Although two-level CRTs are well studied, the effects of subcluster-level attrition and hierarchical covariate correlations on bias and variance are not yet fully explored. We develop an analytical framework for three-level CRTs under multi-level covariate-dependent missingness (CDM), explicitly incorporating within- and between-subcluster covariate correlations. We examine the performance of unadjusted and covariate-adjusted cluster-level treatment effect estimators using Monte Carlo simulations and a plasmode simulation based on the 2021 Madagascar Demographic and Health Survey. Our study reveals that unadjusted cluster-level analyses produce biased estimates under multi-level CDM. Linear mixed models are unbiased when correctly specified under missing-at-random assumptions but may be computationally unstable in small samples. The covariate-adjusted cluster-level estimator remains unbiased when covariate effects and missingness mechanisms are homogeneous across treatment arms. Subcluster-level attrition can lead to greater variance inflation than individual-level attrition. For CRTs with fewer than 30 clusters per arm and homogeneous treatment effects, covariate-adjusted cluster-level analysis may serve as a practical alternative to mixed models. A decision flowchart is provided to guide method selection.

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Publication Details

Journal
Statistical Methods in Medical Research
Published
2026-10-15
DOI
https://doi.org/10.1177/09622802261498389
Primary Topic
Statistical Methods in Clinical Trials
Type
article
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article

Cluster-level analysis in three-level cluster randomised trials with multi-level covariate-dependent missingness

Priyanka Majumder, Satish Pradhan
Statistical Methods in Medical Research
Statistical Methods in Clinical Trials
article

Cluster-level analysis in three-level cluster randomised trials with multi-level covariate-dependent missingness

Priyanka Majumder, Satish Pradhan
article en

Abstract

Community-based public health interventions often use three-level cluster randomised trials (CRTs), for example, individuals are nested within households which are again nested within communities. In these trials, outcome missingness commonly depends on baseline covariates measured at multiple levels. Although two-level CRTs are well studied, the effects of subcluster-level attrition and hierarchical covariate correlations on bias and variance are not yet fully explored. We develop an analytical framework for three-level CRTs under multi-level covariate-dependent missingness (CDM), explicitly incorporating within- and between-subcluster covariate correlations. We examine the performance of unadjusted and covariate-adjusted cluster-level treatment effect estimators using Monte Carlo simulations and a plasmode simulation based on the 2021 Madagascar Demographic and Health Survey. Our study reveals that unadjusted cluster-level analyses produce biased estimates under multi-level CDM. Linear mixed models are unbiased when correctly specified under missing-at-random assumptions but may be computationally unstable in small samples. The covariate-adjusted cluster-level estimator remains unbiased when covariate effects and missingness mechanisms are homogeneous across treatment arms. Subcluster-level attrition can lead to greater variance inflation than individual-level attrition. For CRTs with fewer than 30 clusters per arm and homogeneous treatment effects, covariate-adjusted cluster-level analysis may serve as a practical alternative to mixed models. A decision flowchart is provided to guide method selection.

Statistical Methods in Medical Research
Indian Institute of Science Education and Research Thiruvananthapuram (IN)
Good health and well-being
Openalex Percentile: Top 12%
Statistical Methods in Clinical Trials
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