Evidence map›Paper›PMID 42908226›Full record

ArticleStatistics in medicine2026

Estimating Marginal Odds Ratios for Cluster Randomized Trials: The Cluster-Level GLM.

Jennifer A Thompson, Brennan C Kahan, Andrew Copas

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Article in Statistics in medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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2 · The registry

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4 · The record

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5 · Who and what money

Authors and funding

3 authors.

Jennifer A ThompsonDepartment of Infectious Disease Epidemiology and International Health, London School of Hygiene and Tropical Medicine, London, UK.ORCID https://orcid.org/0000-0002-3068-3952
Brennan C KahanMedical Research Council Centre of Research Excellence in Clinical Trial Innovation in Partnership With NIHR, University College London, London, UK.ORCID https://orcid.org/0000-0001-9957-0844
Andrew CopasMedical Research Council Centre of Research Excellence in Clinical Trial Innovation in Partnership With NIHR, University College London, London, UK.ORCID https://orcid.org/0000-0001-8968-5963

Funding

Medical Research Council MR/X029492/1UK Medical Research Council UKR1934
6 · The paper itself

Abstract

backgroundMethods for estimating marginal effects in cluster randomized trials are limited. We describe and evaluate a cluster-level generalized linear model (CL-GLM) that applies a GLM to cluster-level summaries (means, proportions, or rates) and can estimate differences, ratios, or odds ratios. We focus on odds ratios.

methodsWe conducted a simulation study with 10-50 clusters, intracluster correlation coefficients of 0.05 or 0.15, and a mean cluster size of 120, either fixed or variable. Informative cluster size, where the intervention effect varies with cluster size, was also considered. Control arm prevalence was set to 50%. We compared cluster-level GLMs with normal and gamma distributions and logit link to generalized estimating equations (GEE) and independence estimating equations (IEEs). Weighted and unweighted analyses were examined to target cluster-average and individual-average estimands.

resultsCL-GLM with a normal distribution produced unbiased marginal cluster-average odds ratios with appropriate confidence interval coverage. CL-GLM with a gamma distribution resulted in over-coverage. Unweighted IEE produced unbiased marginal individual-average odds ratios with correct coverage. GEE was unbiased when cluster size was uninformative but biased under informative cluster size. Weighted CL-GLM led to under-coverage, whereas weighted IEE resulted in over-coverage. The CL-GLM had similar power to GEE and unweighted IEE.

conclusionsThe cluster-level GLM with a normal distribution provides a robust alternative to estimating equation approaches for marginal odds ratios in cluster randomized trials, with good performance under both informative and uninformative cluster size and no loss of power. We recommend the cluster-level GLM with a normal distribution when the marginal cluster-average estimand is of interest, and unweighted IEEs when the marginal individual-average estimand is of interest.

Indexed as

Randomized Controlled Trials as TopicCluster AnalysisComputer SimulationHumansLinear ModelsOdds Ratiocluster level analysiscluster randomized trialgeneralized linear modelinformative cluster sizemarginal odds ratiosimulation study

Identifiers

PMID42908226
PMCPMC13687777

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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.