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 deliveryPain
2021
Impact of complex, partially nested clustering in a three-arm individually randomized group treatment trial: A case study with the wHOPE trial
Tong G, Seal KH, Becker WC, Li F, Dziura JD, Peduzzi PN, Esserman DA. Impact of complex, partially nested clustering in a three-arm individually randomized group treatment trial: A case study with the wHOPE trial. Clinical Trials 2021, 19: 3-13. PMID: 34693748, PMCID: PMC8847260, DOI: 10.1177/17407745211051288.Peer-Reviewed Original ResearchConceptsGroup treatment trialsIntraclass correlation coefficientTreatment trialsTreatment sessionsHealth optionsEducation trialThree-armWhole health teamFuture trial designNumber of cliniciansGroup treatment designTrue intraclass correlation coefficientsGroup treatment sessionsTreatment armsClinical trialsClinician levelMultiple cliniciansBACKGROUND/Health teamsOutcome dataTreatment groupsTrial designGroup educationClinical scenariosDifferent clinicians