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
2003
An open-label randomized clinical trial of novel therapeutic strategies for HIV-infected patients in whom antiretroviral therapy has failed: rationale and design of the OPTIMA Trial
Kyriakides TC, Babiker A, Singer J, Cameron W, Schechter MT, Holodniy M, Brown ST, Youle M, Gazzard B, Team O. An open-label randomized clinical trial of novel therapeutic strategies for HIV-infected patients in whom antiretroviral therapy has failed: rationale and design of the OPTIMA Trial. Contemporary Clinical Trials 2003, 24: 481-500. PMID: 12865041, DOI: 10.1016/s0197-2456(03)00029-1.Peer-Reviewed Original ResearchConceptsOPTIMA trialClinical trialsTherapeutic strategiesHuman immunodeficiency virus-infected individualsVirus-infected individualsDrug-free periodVeterans Affairs hospitalDifferent therapeutic strategiesYears of intakeNovel therapeutic strategiesAnti-HIV drugsAntiretroviral therapyStrategy armART drugsTrial designHIV drugsStudy durationHospitalTrialsRelative efficacyDrugsTherapyOptimum trial designYearsMulticenter