2024
Adapting 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 ResearchMeSH KeywordsCOVID-19Data Interpretation, StatisticalHumansPain ManagementPragmatic Clinical Trials as TopicResearch DesignConceptsPragmatic 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 boardOutcomesTrialsUtility 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
2016
The design and implementation of a randomized controlled trial of a risk reduction and human immunodeficiency virus prevention videogame intervention in minority adolescents: PlayForward: Elm City Stories
Fiellin LE, Kyriakides TC, Hieftje KD, Pendergrass TM, Duncan LR, Dziura JD, Sawyer BG, Fiellin DA. The design and implementation of a randomized controlled trial of a risk reduction and human immunodeficiency virus prevention videogame intervention in minority adolescents: PlayForward: Elm City Stories. Clinical Trials 2016, 13: 400-408. PMID: 27013483, PMCID: PMC4942329, DOI: 10.1177/1740774516637871.Peer-Reviewed Original ResearchConceptsGame dataHuman immunodeficiency virus (HIV) infectionHuman immunodeficiency virus prevention interventionsPsychosocial antecedentsImmunodeficiency virus infectionRisk behavior reductionVideogame interventionMinority adolescentsBehavioral interventionsRisky sexual behaviorLarge-scale trialsMinority youthControl gameCommunity-based programsPeer pressureAssessment dataSummer campStudy visitBehavior reductionVirus infectionPrevention interventionsGame designersSchool programsAdolescentsEmpiric testing
2010
Methodological Issues in Comparative Effectiveness Research: Clinical Trials
Peduzzi P, Kyriakides T, O'Connor TZ, Guarino P, Warren SR, Huang GD. Methodological Issues in Comparative Effectiveness Research: Clinical Trials. The American Journal Of Medicine 2010, 123: e8-e15. PMID: 21184867, DOI: 10.1016/j.amjmed.2010.10.003.Peer-Reviewed Original ResearchConceptsComparative effectiveness clinical trialEffectiveness clinical trialClinical trialsVeterans Affairs Cooperative Studies ProgramCooperative Studies ProgramComparative effectiveness researchMechanism of actionUsual careDiabetes mellitusRheumatoid arthritisFuture trialsClinical equipoisePatient preferencesRisk factorsNeurologic disordersInfectious diseasesMental healthTrialsDisease areasEffectiveness researchPharmaceutical issuesType of studyValid comparisonsMellitusArthritis
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