2025
Guidelines for the content of statistical analysis plans in clinical trials: protocol for an extension to cluster randomized trials
Hemming K, Thompson J, Hooper R, Ukoumunne O, Li F, Caille A, Kahan B, Leyrat C, Grayling M, Mohammed N, Thompson J, Giraudeau B, Turner E, Watson S, Goulão B, Kasza J, Forbes A, Copas A, Taljaard M. Guidelines for the content of statistical analysis plans in clinical trials: protocol for an extension to cluster randomized trials. Trials 2025, 26: 72. PMID: 40011934, PMCID: PMC11866560, DOI: 10.1186/s13063-025-08756-3.Peer-Reviewed Original Research
2021
Clarifying selection bias in cluster randomized trials
Li F, Tian Z, Bobb J, Papadogeorgou G, Li F. Clarifying selection bias in cluster randomized trials. Clinical Trials 2021, 19: 33-41. PMID: 34894795, DOI: 10.1177/17407745211056875.Peer-Reviewed Original ResearchConceptsAverage treatment effectCluster randomized trialPost-randomization selection biasPrincipal strataAnalysis of cluster randomized trialsSelection biasCausal effectsCovariate adjustment methodsData generating processRecruited populationPrincipal stratification frameworkPresence of selection biasHeterogeneous treatment effectsRegression adjustment methodEstimate causal effectsRandomized trialsElectronic health recordsOverall populationEffect heterogeneityIntention-to-treat analysisSimulation studyTreatment effectsEmpirical performanceEstimandsEstimation strategy
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