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 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 boardOutcomesTrialsRecommendations for monitoring adherence and fidelity in pragmatic trials based on experience in the Pain Management Collaboratory
Dziura J, Gilstad-Hayden K, Coffman C, Long C, Yu Q, Buta E, Coggeshall S, Geda M, Peduzzi P, Kyriakides T. Recommendations for monitoring adherence and fidelity in pragmatic trials based on experience in the Pain Management Collaboratory. Pain Medicine 2024, 25: s41-s48. PMID: 39514878, PMCID: PMC11548857, DOI: 10.1093/pm/pnae080.Peer-Reviewed Original ResearchConceptsPain Management CollaboratoryPragmatic trialPragmatic Explanatory Continuum Indicator SummaryMonitor adherenceElectronic health recordsFidelity dataIntervention deliveryIntervention fidelityIndicator SummaryHealth recordsTrial interventionProtocol adherenceParticipant engagementStudy teamAdherence dataAdherenceTrial integrityInterventionParticipantsSafety monitoring boardFrequent sourcePainLevel of monitoringTrialsMonitoring boardUtility 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
2017
Video Game Intervention for Sexual Risk Reduction in Minority Adolescents: Randomized Controlled Trial
Fiellin LE, Hieftje KD, Pendergrass TM, Kyriakides TC, Duncan LR, Dziura JD, Sawyer BG, Mayes L, Crusto CA, Forsyth BW, Fiellin DA. Video Game Intervention for Sexual Risk Reduction in Minority Adolescents: Randomized Controlled Trial. Journal Of Medical Internet Research 2017, 19: e314. PMID: 28923788, PMCID: PMC5625130, DOI: 10.2196/jmir.8148.Peer-Reviewed Original ResearchConceptsSexual health attitudesHuman immunodeficiency virusIntervention groupHealth attitudesInitiation of intercourseVideo game interventionControl groupHIV sexual riskSexual health outcomesSexual risk reductionDelay of initiationDigital health interventionsSecondary outcomesControlled TrialsGame interventionPrimary outcomeImmunodeficiency virusMean ageAnal intercourseHealth outcomesHealth interventionsSexual riskMonthsMinority adolescentsIntervention
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
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