2024
Utility of the PICOTS framework to assess clinical trial disruptions: monitoring the impact of COVID-19 in the Pain Management Collaboratory
Peduzzi P, Brandt C, Dearth C, Dziura J, Farrokhi S, George S, Kyriakides T, Long C, Mascha E, Patterson C, Rhon D, Kerns R. Utility of the PICOTS framework to assess clinical trial disruptions: monitoring the impact of COVID-19 in the Pain Management Collaboratory. Pain Medicine 2024, 25: s34-s40. PMID: 39514876, PMCID: PMC11548861, DOI: 10.1093/pm/pnae078.Peer-Reviewed Original ResearchConceptsPain Management CollaboratoryPICOTS frameworkIndividual-level randomizationPain management researchPragmatic clinical trialsIntervention fidelityCare deliveryStepped-wedgeSpecialty careClinical partnersCOVID-19 experienceIn-personPain managementOutcome assessmentStudy designCOVID-19Nonpharmacologic approachesImpact of COVID-19PICOTExperimental interventionLead investigatorsTrial designDesign of clinical trialsAffective deliveryPainAdapting to change: experiences and recommendations from the Pain Management Collaboratory on modifying statistical analysis plans
Yu Q, George S, Kyriakides T, Rhon D, Morasco B, Dziura J, Fritz J, Geda M, Peduzzi P, Long C. Adapting to change: experiences and recommendations from the Pain Management Collaboratory on modifying statistical analysis plans. Pain Medicine 2024, 25: s49-s53. PMID: 39514871, PMCID: PMC11548855, DOI: 10.1093/pm/pnae073.Peer-Reviewed Original ResearchConceptsPragmatic clinical trialsPain Management CollaboratoryStatistical analysis planTrial protocolAnalysis planEvaluate nonpharmacological interventionsNonpharmacological interventionsTrial launchStudy designSecondary outcomesTrials RegistryPrimary outcomeStudy armsPrincipal investigatorInstitutional review boardClinical trialsTrial initiationCOVID-19-related issuesBest practicesPainSample sizeReview boardSafety monitoring boardOutcomesTrials
2007
Methodological issues in design and analysis of a matched case–control study of a vaccine's effectiveness
Niccolai LM, Ogden LG, Muehlenbein CE, Dziura JD, Vázquez M, Shapiro ED. Methodological issues in design and analysis of a matched case–control study of a vaccine's effectiveness. Journal Of Clinical Epidemiology 2007, 60: 1127-1131. PMID: 17938054, PMCID: PMC2096633, DOI: 10.1016/j.jclinepi.2007.02.009.Peer-Reviewed Original ResearchConceptsCase-control studyTime of vaccinationConditional logistic regression modelsPrelicensure clinical trialsLogistic regression modelsVaricella vaccineVaccine effectivenessVaccine efficacyClinical trialsVaccinationVaccineStudy designRegression modelsEfficacyAgeEffect of timeMethodological issuesTrials