A Bayesian Framework for Latent Compliance Modeling in Cluster Randomized Trials with One-Sided Noncompliance

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Hauptverfasser: Sisti, Anthony, McCreedy, Ellen, Gutman, Roee
Format: Preprint
Veröffentlicht: 2025
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author Sisti, Anthony
McCreedy, Ellen
Gutman, Roee
author_facet Sisti, Anthony
McCreedy, Ellen
Gutman, Roee
contents In pragmatic cluster randomized controlled trials (PCRCTs), healthcare providers are randomized while both providers and patients may deviate from the assigned intervention. In many PCRCTs, cluster-level implementation is measured using multiple continuous metrics, while individual compliance is recorded as a binary indicator. Standard complier average causal effect (CACE) estimands focus on individual-level compliance and do not account for heterogeneity in implementation across clusters. When intervention uptake is shaped by both provider- and patient-level processes, it is of scientific interest to characterize how effects vary across these sources of compliance. We propose a Bayesian framework for PCRCTs with one-sided binary noncompliance at the individual level and one-sided partial compliance at the cluster level. The method uses a latent mixture model to summarize heterogeneity in cluster-level implementation based on baseline characteristics and observed implementation measures, and links these latent implementation types to individual compliance and outcomes through a joint model. Because compliance is only observed in treated clusters, the model imputes unobserved compliance behavior for clusters and individuals assigned to control. The framework enables estimation of finite- and super-population intent-to-treat (ITT) and CACE estimands, both marginally and within latent implementation types. We apply the method to the METRIcAL trial, a pragmatic cluster randomized study evaluating a personalized music intervention for nursing home residents with dementia. The analysis illustrates how accounting for implementation heterogeneity and individual compliance can provide insights beyond standard ITT analyses.}{Causal inference; Principal stratification; Complier average causal effect; Cluster randomized trials; Noncompliance; Bayesian methods; Latent variable models; Interference.
format Preprint
id arxiv_https___arxiv_org_abs_2509_15280
institution arXiv
publishDate 2025
record_format arxiv
spellingShingle A Bayesian Framework for Latent Compliance Modeling in Cluster Randomized Trials with One-Sided Noncompliance
Sisti, Anthony
McCreedy, Ellen
Gutman, Roee
Applications
Methodology
In pragmatic cluster randomized controlled trials (PCRCTs), healthcare providers are randomized while both providers and patients may deviate from the assigned intervention. In many PCRCTs, cluster-level implementation is measured using multiple continuous metrics, while individual compliance is recorded as a binary indicator. Standard complier average causal effect (CACE) estimands focus on individual-level compliance and do not account for heterogeneity in implementation across clusters. When intervention uptake is shaped by both provider- and patient-level processes, it is of scientific interest to characterize how effects vary across these sources of compliance. We propose a Bayesian framework for PCRCTs with one-sided binary noncompliance at the individual level and one-sided partial compliance at the cluster level. The method uses a latent mixture model to summarize heterogeneity in cluster-level implementation based on baseline characteristics and observed implementation measures, and links these latent implementation types to individual compliance and outcomes through a joint model. Because compliance is only observed in treated clusters, the model imputes unobserved compliance behavior for clusters and individuals assigned to control. The framework enables estimation of finite- and super-population intent-to-treat (ITT) and CACE estimands, both marginally and within latent implementation types. We apply the method to the METRIcAL trial, a pragmatic cluster randomized study evaluating a personalized music intervention for nursing home residents with dementia. The analysis illustrates how accounting for implementation heterogeneity and individual compliance can provide insights beyond standard ITT analyses.}{Causal inference; Principal stratification; Complier average causal effect; Cluster randomized trials; Noncompliance; Bayesian methods; Latent variable models; Interference.
title A Bayesian Framework for Latent Compliance Modeling in Cluster Randomized Trials with One-Sided Noncompliance
topic Applications
Methodology
url https://arxiv.org/abs/2509.15280