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 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 boardOutcomesTrialsFormative evaluation of an emergency department clinical decision support system for agitation symptoms: a study protocol
Wong A, Nath B, Shah D, Kumar A, Brinker M, Faustino I, Boyce M, Dziura J, Heckmann R, Yonkers K, Bernstein S, Adapa K, Taylor R, Ovchinnikova P, McCall T, Melnick E. Formative evaluation of an emergency department clinical decision support system for agitation symptoms: a study protocol. BMJ Open 2024, 14: e082834. PMID: 38373857, PMCID: PMC10882402, DOI: 10.1136/bmjopen-2023-082834.Peer-Reviewed Original ResearchConceptsComputerised clinical decision supportED treatRestraint useExperiences of restraint useMental health-related visitsEmergency departmentPrevent agitationSystems-related factorsImprove patient experienceClinical decision support systemsRegional health systemClinical decision supportDe-escalation techniquesRandomised controlled trialsFormative evaluationPeer-reviewed journalsBest-practice guidanceAt-risk populationsCDS toolsThematic saturationED cliniciansPatient experienceED sitesHealth systemED physicians
2022
Sample size calculation in hierarchical 2×2 factorial trials with unequal cluster sizes
Tian Z, Esserman D, Tong G, Blaha O, Dziura J, Peduzzi P, Li F. Sample size calculation in hierarchical 2×2 factorial trials with unequal cluster sizes. Statistics In Medicine 2022, 41: 645-664. PMID: 34978097, PMCID: PMC8962918, DOI: 10.1002/sim.9284.Peer-Reviewed Original Research
2021
Advances in clinical trials methodology: Intervention optimization approaches in emergency medicine
Bernstein SL, Carter PM, Meurer W, Walton MA, Kidwell KM, Cunningham RM, Dziura J, Collins LM. Advances in clinical trials methodology: Intervention optimization approaches in emergency medicine. The American Journal Of Emergency Medicine 2021, 53: 6-11. PMID: 34968972, PMCID: PMC8844226, DOI: 10.1016/j.ajem.2021.12.028.Peer-Reviewed Original ResearchImpact 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
2020
Trial study design to test a bilingual digital health tool for alcohol use disorders among Latino emergency department patients
Vaca FE, Dziura J, Abujarad F, Pantalon MV, Hsiao A, Field CA, D'Onofrio G. Trial study design to test a bilingual digital health tool for alcohol use disorders among Latino emergency department patients. Contemporary Clinical Trials 2020, 96: 106104. PMID: 32777381, PMCID: PMC8252296, DOI: 10.1016/j.cct.2020.106104.Peer-Reviewed Original ResearchMeSH KeywordsAdultAlcohol DrinkingAlcoholismEmergency Service, HospitalHispanic or LatinoHumansMass ScreeningResearch DesignConceptsAlcohol use disorderBrief interventionSevere alcohol use disorderUse disordersBinge drinking daysSpecialized treatment servicesAlcohol-related health disparitiesAlcohol screeningBrief intervention toolTimeline followback methodHigh-risk drinkingNegative behaviorsTreatment engagementAUD severityImpaired driversStandard careDrinking daysMeaningful contactIntervention toolDigital health toolsUnhealthy drinkingPrimary outcomeLatino patientsHealth toolsWork/schoolQuality and Publication of Emergency Medicine Trials Registered in ClinicalTrials.gov
Calvocoressi L, Reynolds J, Johnson B, Warzoha MM, Carroll M, Vaca FE, Post L, Dziura J. Quality and Publication of Emergency Medicine Trials Registered in ClinicalTrials.gov. Western Journal Of Emergency Medicine 2020, 21: 295-303. PMID: 32191186, PMCID: PMC7081876, DOI: 10.5811/westjem.2019.12.44096.Peer-Reviewed Original ResearchMeSH KeywordsClinical Trials as TopicEmergency MedicineHumansNational Institutes of Health (U.S.)PublicationsResearch DesignUnited StatesConceptsClinical trialsEM trialsKaplan-Meier curvesLog-rank testNational clinical trialClinical trial researchChi-square testEM studiesTrial qualityInterventional trialsPeer-reviewed journalsMedicine trialsNeurological conditionsLarger sample sizeTrial researchStudy characteristicsStudy periodTrialsNational InstituteSubspecialty areasBlindingPeriodic assessmentDescriptive statisticsHigher proportionIndustry funding
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
2013
Strategies for dealing with missing data in clinical trials: from design to analysis.
Dziura JD, Post LA, Zhao Q, Fu Z, Peduzzi P. Strategies for dealing with missing data in clinical trials: from design to analysis. The Yale Journal Of Biology And Medicine 2013, 86: 343-58. PMID: 24058309, PMCID: PMC3767219.Peer-Reviewed Original Research
2012
Brief Report: Social Disability in Autism Spectrum Disorder: Results from Research Units on Pediatric Psychopharmacology (RUPP) Autism Network Trials
Scahill L, Hallett V, Aman MG, McDougle CJ, Eugene Arnold L, McCracken JT, Tierney E, Deng Y, Dziura J, Vitiello B, the Research Units on Pediatric Psychopharmacology (RUPP) Autism Network). Brief Report: Social Disability in Autism Spectrum Disorder: Results from Research Units on Pediatric Psychopharmacology (RUPP) Autism Network Trials. Journal Of Autism And Developmental Disorders 2012, 43: 739-746. PMID: 23104617, PMCID: PMC3886122, DOI: 10.1007/s10803-012-1689-3.Peer-Reviewed Original ResearchConceptsSocial Withdrawal subscaleSocial disabilityWithdrawal subscaleAcute treatment trialsWeeks of treatmentDouble-blind conditionsAutism spectrum disorderMedication trialsActive treatmentTreatment trialsSpectrum disorderNetwork trialSecondary analysisRisperidoneTrialsPlaceboDisabilityParent trainingSubjectsDisordersTreatmentSubscalesUseful measureResearch UnitWeeks