Public Health Impacts of Vaccines for COVID-19 and Beyond: Opportunities to Overcome Technical and Regulatory Barriers for Randomized Trials.
Kennedy-Shaffer L. Public Health Impacts of Vaccines for COVID-19 and Beyond: Opportunities to Overcome Technical and Regulatory Barriers for Randomized Trials. American Journal Of Public Health 2023, 113: 778-785. PMID: 37104734, PMCID: PMC10262256, DOI: 10.2105/ajph.2023.307302.Peer-Reviewed Original ResearchConceptsPublic health impactCOVID-19 pandemicPopulation healthEvidence baseCOVID-19Health impactsInfectious disease outbreaksCommunity levelRandomized trialsIndividual levelRegulatory barriersPivotal trialsClinical benefitTrialsClinical trialsVaccine trialsPrevent infectionStrategic deploymentVaccineHealthThe required size of cluster randomized trials of nonpharmaceutical interventions in epidemic settings
Sheen J, Haushofer J, Metcalf C, Kennedy‐Shaffer L. The required size of cluster randomized trials of nonpharmaceutical interventions in epidemic settings. Statistics In Medicine 2022, 41: 2466-2482. PMID: 35257398, PMCID: PMC9111156, DOI: 10.1002/sim.9365.Peer-Reviewed Original ResearchConceptsCluster randomized trialEffectiveness of interventionsSample sizeRandomized trialsPlanning such trialsApproximate sample size formulaeReduce transmissionEffect sizeNonpharmaceutical interventionsInfectious disease outbreaksObservational studyInterventionEpidemic settingsSample size methodsAdequate powerSARS-CoV-2 pandemicSARS-CoV-2 transmissionSample size formulaTested individualsSimulated bankTreatment effectsTrialsCommunity transmissionOutbreak settingsSize formulaSample size estimation for stratified individual and cluster randomized trials with binary outcomes
Kennedy‐Shaffer L, Hughes M. Sample size estimation for stratified individual and cluster randomized trials with binary outcomes. Statistics In Medicine 2020, 39: 1489-1513. PMID: 32003492, PMCID: PMC7247053, DOI: 10.1002/sim.8492.Peer-Reviewed Original ResearchConceptsCluster randomized trialIndividual randomized trialsIntracluster correlation coefficientSample size estimationBinary outcomesRandomized trialsSample sizeStratify individualsLogistic regressionSample size reductionProbabilities of eventsContinuous outcomesSize estimationStratified trialCorrelation coefficientOutcomesTrialsEstimationProbability