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 boardOutcomesTrials
2021
Design and Implementation of an Agitation Code Response Team in the Emergency Department
Wong AH, Ray JM, Cramer LD, Brashear TK, Eixenberger C, McVaney C, Haggan J, Sevilla M, Costa DS, Parwani V, Ulrich A, Dziura JD, Bernstein SL, Venkatesh AK. Design and Implementation of an Agitation Code Response Team in the Emergency Department. Annals Of Emergency Medicine 2021, 79: 453-464. PMID: 34863528, PMCID: PMC9038629, DOI: 10.1016/j.annemergmed.2021.10.013.Peer-Reviewed Original ResearchConceptsResponse team interventionPhysical restraint useInterrupted time series analysisRestraint useEmergency departmentTeam interventionRates of physical restraint useTeam-based interventionAdministrative supportQuality improvement studyResponse teamBehavioral health systemManagement of agitated patientsInterprofessional collaborationRestraint ordersExcessive psychomotor activityRestraint ratesHealth systemED visitsImprovement studyPhysical restraintCompare trendsPrimary outcomeTime series analysisAgitated patientsA SMARTTT approach to Treating Tobacco use disorder in persons with HIV (SMARTTT): Rationale and design for a hybrid type 1 effectiveness-implementation study
Edelman EJ, Dziura J, Deng Y, Bold KW, Murphy SM, Porter E, Sigel KM, Yager JE, Ledgerwood DM, Bernstein SL. A SMARTTT approach to Treating Tobacco use disorder in persons with HIV (SMARTTT): Rationale and design for a hybrid type 1 effectiveness-implementation study. Contemporary Clinical Trials 2021, 110: 106379. PMID: 33794354, PMCID: PMC8478961, DOI: 10.1016/j.cct.2021.106379.Peer-Reviewed Original ResearchConceptsTobacco use disorderNicotine replacement therapyUse disordersHIV clinicHybrid type 1 effectiveness-implementation designHIV viral load suppressionCD4 cell countViral load suppressionEffectiveness-implementation studyOptimal treatment approachPharmacist-delivered interventionSequential multiple assignmentHealth of personsImplementation science frameworkSecondary outcomesAntiretroviral treatmentPrimary outcomeClinical pharmacistsReplacement therapySmoking abstinenceTreatment approachesCell countHealth systemHIVContingency managementThe design and conduct of a randomized clinical trial comparing emergency department initiation of sublingual versus a 7-day extended-release injection formulation of buprenorphine for opioid use disorder: Project ED Innovation
D'Onofrio G, Hawk KF, Herring AA, Perrone J, Cowan E, McCormack RP, Dziura J, Taylor RA, Coupet E, Edelman EJ, Pantalon MV, Owens PH, Martel SH, O'Connor PG, Van Veldhuisen P, DeVogel N, Huntley K, Murphy SM, Lofwall MR, Walsh SL, Fiellin DA. The design and conduct of a randomized clinical trial comparing emergency department initiation of sublingual versus a 7-day extended-release injection formulation of buprenorphine for opioid use disorder: Project ED Innovation. Contemporary Clinical Trials 2021, 104: 106359. PMID: 33737199, PMCID: PMC9153252, DOI: 10.1016/j.cct.2021.106359.Peer-Reviewed Original ResearchConceptsOpioid use disorderRandomized clinical trialsPrimary outcomeFormal addiction treatmentOpioid withdrawalClinical trialsAncillary studiesUse disordersSelf-reported opioid useAddiction treatmentEmergency department initiationIncremental cost-effectiveness ratioReceipt of medicationEmergency department studyHealth service utilizationCost-effectiveness ratioOpioid useSecondary outcomesService utilizationTreatment accessEligibility criteriaImplementation facilitationBuprenorphineOverdose eventsDepartment studyA case study of ascertainment bias for the primary outcome in the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) trial
Esserman DA, Gill TM, Miller ME, Greene EJ, Dziura JD, Travison TG, Meng C, Peduzzi PN. A case study of ascertainment bias for the primary outcome in the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) trial. Clinical Trials 2021, 18: 207-214. PMID: 33678038, PMCID: PMC8009806, DOI: 10.1177/1740774520980070.Peer-Reviewed Original ResearchConceptsPrimary outcome definitionUsual care armSerious fall injuriesMedical attentionOutcome definitionsFall injuriesElders trialCare armOvernight hospitalizationStudy powerCare managersIntervention effectsType 2 injuriesAscertainment biasAscertainment of outcomesInterim monitoring planUsual careHazard ratioPrimary outcomeIntervention armClinical trialsUnblinded observerClinical basisMulticomponent interventionAdditional fall
2020
D‐CARE: The Dementia Care Study: Design of a Pragmatic Trial of the Effectiveness and Cost Effectiveness of Health System–Based Versus Community‐Based Dementia Care Versus Usual Dementia Care
Reuben DB, Gill TM, Stevens A, Williamson J, Volpi E, Lichtenstein M, Jennings LA, Tan Z, Evertson L, Bass D, Weitzman L, Carnie M, Wilson N, Araujo K, Charpentier P, Meng C, Greene EJ, Dziura J, Liu J, Unger E, Yang M, Currie K, Lenoir KM, Green A, Abraham S, Vernon A, Samper‐Ternent R, Raji M, Hirst RM, Galloway R, Finney GR, Ladd I, Rahm AK, Borek P, Peduzzi P. D‐CARE: The Dementia Care Study: Design of a Pragmatic Trial of the Effectiveness and Cost Effectiveness of Health System–Based Versus Community‐Based Dementia Care Versus Usual Dementia Care. Journal Of The American Geriatrics Society 2020, 68: 2492-2499. PMID: 32949145, PMCID: PMC8086629, DOI: 10.1111/jgs.16862.Peer-Reviewed Original ResearchConceptsCommunity-based dementia careUsual careClinical trial sitesDementia careHealth systemCaregiver unmet needsNursing home placement ratesClinical health systemsDementia care specialistsUnit of randomizationQuality of lifeCost effectivenessDementia Care StudyPrimary outcomeClinical benefitSuperiority trialFunctional statusPragmatic trialCaregiver dyadsCare specialistsComprehensive careCaregiver distressCare studiesMedicare claimsNurse practitionersTrial 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, 97: 106128. PMID: 32950400, PMCID: PMC7721867, DOI: 10.1016/j.cct.2020.106128.Peer-Reviewed Original ResearchAlcohol 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/schoolTrial 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 ResearchConceptsAlcohol 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/schoolExenatide extended release in patients with type 1 diabetes with and without residual insulin production
Herold KC, Reynolds J, Dziura J, Baidal D, Gaglia J, Gitelman SE, Gottlieb PA, Marks J, Philipson LH, Pop‐Busui R, Weinstock RS. Exenatide extended release in patients with type 1 diabetes with and without residual insulin production. Diabetes Obesity And Metabolism 2020, 22: 2045-2054. PMID: 32573927, PMCID: PMC8009602, DOI: 10.1111/dom.14121.Peer-Reviewed Original ResearchConceptsExenatide extended releaseResidual insulin productionBeta-cell functionType 1 diabetesC-peptidePlacebo groupPrimary outcomeWeek 12ER groupInsulin productionDetectable C-peptide levelsResidual beta-cell functionGLP-1 receptor agonistsRandomized placebo-controlled trialExtended releaseTotal insulin doseMean HbA1c levelPlacebo-controlled trialC-peptide levelsDetectable levelsCell functionShort-term improvementHbA1c levelsStudy drugAdverse eventsA Randomized Trial of a Multifactorial Strategy to Prevent Serious Fall Injuries
Bhasin S, Gill TM, Reuben DB, Latham NK, Ganz DA, Greene EJ, Dziura J, Basaria S, Gurwitz JH, Dykes PC, McMahon S, Storer TW, Gazarian P, Miller ME, Travison TG, Esserman D, Carnie MB, Goehring L, Fagan M, Greenspan SL, Alexander N, Wiggins J, Ko F, Siu AL, Volpi E, Wu AW, Rich J, Waring SC, Wallace RB, Casteel C, Resnick NM, Magaziner J, Charpentier P, Lu C, Araujo K, Rajeevan H, Meng C, Allore H, Brawley BF, Eder R, McGloin JM, Skokos EA, Duncan PW, Baker D, Boult C, Correa-de-Araujo R, Peduzzi P. A Randomized Trial of a Multifactorial Strategy to Prevent Serious Fall Injuries. New England Journal Of Medicine 2020, 383: 129-140. PMID: 32640131, PMCID: PMC7421468, DOI: 10.1056/nejmoa2002183.Peer-Reviewed Original ResearchConceptsSerious fall injuriesFall injuriesIntervention groupControl groupUsual careMultifactorial interventionRate of hospitalizationPrimary care practicesCluster-randomized trialCommunity-dwelling adultsFirst-event analysisYears of ageHealth care systemRate of fallElectronic health recordsBaseline characteristicsPrimary outcomeRandomized trialsMean ageEfficacy trialsIndividualized planCare practicesInjuryMultifactorial strategyEvent ratesInterrupted Time Series of User‐centered Clinical Decision Support Implementation for Emergency Department–initiated Buprenorphine for Opioid Use Disorder
Holland WC, Nath B, Li F, Maciejewski K, Paek H, Dziura J, Rajeevan H, Lu CC, Katsovich L, D'Onofrio G, Melnick ER. Interrupted Time Series of User‐centered Clinical Decision Support Implementation for Emergency Department–initiated Buprenorphine for Opioid Use Disorder. Academic Emergency Medicine 2020, 27: 753-763. PMID: 32352206, PMCID: PMC7496559, DOI: 10.1111/acem.14002.Peer-Reviewed Original ResearchConceptsOpioid use disorderComputerized clinical decision support systemsRates of EDBUP initiationUse disordersClinical decision support implementationEmergency department initiationRoutine emergency careInterrupted time series studyAdult ED patientsInterrupted time seriesClinical decision support systemElectronic health recordsClinicians' unfamiliarityED initiationDecision support implementationED dischargeOpioid withdrawalSecondary outcomesOngoing trialsPrimary outcomeAcademic EDED patientsSingle EDUnique patients
2019
Feasibility of text messaging to augment brief advice and nicotine replacement therapy for smoking cessation in college students
Camenga DR, Bernstein SL, Dziura J, Fiellin L, Krishnan-Sarin S. Feasibility of text messaging to augment brief advice and nicotine replacement therapy for smoking cessation in college students. Journal Of American College Health 2019, 69: 1-8. PMID: 31373882, PMCID: PMC6995438, DOI: 10.1080/07448481.2019.1643730.Peer-Reviewed Original ResearchConceptsNicotine patch therapyBrief advicePatch therapyYoung adult cigarette smokersFeasibility of textNicotine replacement therapyAdult cigarette smokersSmoking cessation interventionText messagingCollege-age smokersPrimary outcomeAbstinence ratesCessation interventionsCigarette smokersReplacement therapyControl armFeasibility dataTherapySmokersInterventionText interventionAdviceSmokingRetention rateTrialsUser-centred clinical decision support to implement emergency department-initiated buprenorphine for opioid use disorder: protocol for the pragmatic group randomised EMBED trial
Melnick ER, Jeffery MM, Dziura JD, Mao JA, Hess EP, Platts-Mills TF, Solad Y, Paek H, Martel S, Patel MD, Bankowski L, Lu C, Brandt C, D’Onofrio G. User-centred clinical decision support to implement emergency department-initiated buprenorphine for opioid use disorder: protocol for the pragmatic group randomised EMBED trial. BMJ Open 2019, 9: e028488. PMID: 31152039, PMCID: PMC6550013, DOI: 10.1136/bmjopen-2018-028488.Peer-Reviewed Original ResearchMeSH KeywordsAdultBuprenorphineCluster AnalysisDecision Support Systems, ClinicalEmergency Service, HospitalFemaleHumansMaleMiddle AgedMulticenter Studies as TopicNarcotic AntagonistsOpiate Substitution TreatmentOpioid-Related DisordersPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicUnited StatesYoung AdultConceptsOpioid use disorderEmergency departmentSecondary outcomesUse disordersEmergency department-initiated buprenorphineWestern Institutional Review BoardData Safety Monitoring BoardIndependent study monitorsRates of cliniciansRoutine emergency careSafety monitoring boardInstitutional review boardClinical decision support systemClinician prescribingPragmatic clusterPatient characteristicsPeer-reviewed journalsClinical decision supportPrimary outcomeED cliniciansWithdrawal symptomsOngoing treatmentPatients' willingnessMonitoring boardBuprenorphineIntegrated stepped alcohol treatment for patients with HIV and alcohol use disorder: a randomised controlled trial
Edelman EJ, Maisto SA, Hansen NB, Cutter CJ, Dziura J, Deng Y, Fiellin LE, O'Connor PG, Bedimo R, Gibert CL, Marconi VC, Rimland D, Rodriguez-Barradas MC, Simberkoff MS, Tate JP, Justice AC, Bryant KJ, Fiellin DA. Integrated stepped alcohol treatment for patients with HIV and alcohol use disorder: a randomised controlled trial. The Lancet HIV 2019, 6: e509-e517. PMID: 31109915, PMCID: PMC7161741, DOI: 10.1016/s2352-3018(19)30076-1.Peer-Reviewed Original ResearchConceptsAlcohol use disorderWeek 24Use disordersAlcohol treatmentAdverse eventsNumber of drinksTreatment medicationsPhysician managementAlcohol abuseMental Disorders-IV criteriaAlcohol-related careFormal alcohol treatmentKey exclusion criteriaTimeline followback methodMotivational enhancement therapyTreat populationHIV clinicHIV outcomesPrimary outcomeSpecialty referralsMean ageUS National InstitutesWeek 4Medical conditionsExclusion criteria
2017
Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE): A Cluster-Randomized Pragmatic Trial of a Multifactorial Fall Injury Prevention Strategy: Design and Methods
Bhasin S, Gill TM, Reuben DB, Latham NK, Gurwitz JH, Dykes P, McMahon S, Storer TW, Duncan PW, Ganz DA, Basaria S, Miller ME, Travison TG, Greene EJ, Dziura J, Esserman D, Allore H, Carnie MB, Fagan M, Hanson C, Baker D, Greenspan SL, Alexander N, Ko F, Siu AL, Volpi E, Wu AW, Rich J, Waring SC, Wallace R, Casteel C, Magaziner J, Charpentier P, Lu C, Araujo K, Rajeevan H, Margolis S, Eder R, McGloin JM, Skokos E, Wiggins J, Garber L, Clauser SB, Correa-De-Araujo R, Peduzzi P. Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE): A Cluster-Randomized Pragmatic Trial of a Multifactorial Fall Injury Prevention Strategy: Design and Methods. The Journals Of Gerontology Series A 2017, 73: 1053-1061. PMID: 29045582, PMCID: PMC6037050, DOI: 10.1093/gerona/glx190.Peer-Reviewed Original ResearchConceptsSerious fall injuriesInjury prevention strategiesFall injuriesPragmatic trialHealth care systemUsual carePrevention strategiesControl groupOlder adultsCare systemMultifactorial risk assessmentCommunity-living personsEnhanced usual carePrimary outcome rateIndividualized care plansPrimary care practicesTarget sample sizeEvidence-based informationSecondary outcomesPrimary outcomeOutcome ratesComanagement modelFall preventionSTRIDE studyMedical attentionVideo 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 adolescentsInterventionDepression is associated with recurrent chest pain with or without coronary artery disease: A prospective cohort study in the emergency department
Kim Y, Soffler M, Paradise S, Jelani QU, Dziura J, Sinha R, Safdar B. Depression is associated with recurrent chest pain with or without coronary artery disease: A prospective cohort study in the emergency department. American Heart Journal 2017, 191: 47-54. PMID: 28888269, DOI: 10.1016/j.ahj.2017.06.003.Peer-Reviewed Original ResearchConceptsRecurrent chest painCoronary artery diseaseAcute chest painChest painProspective cohort studyChest pain centerClinical Anxiety ScaleEmergency departmentPerceived Stress ScalePain centerCohort studyArtery diseaseNonobstructive coronary artery diseaseObstructive coronary artery diseaseChest pain recurrenceED chest painCardiac risk factorsCardiac stress testingPatient Health QuestionnaireSignificant independent predictorsStress testingMultivariable regression modelsPain recurrenceIndependent predictorsPrimary outcomeRanolazine and Microvascular Angina by PET in the Emergency Department: Results From a Pilot Randomized Controlled Trial
Safdar B, D’Onofrio G, Dziura J, Russell RR, Johnson C, Sinusas AJ. Ranolazine and Microvascular Angina by PET in the Emergency Department: Results From a Pilot Randomized Controlled Trial. Clinical Therapeutics 2017, 39: 55-63. PMID: 28081848, PMCID: PMC10345862, DOI: 10.1016/j.clinthera.2016.12.002.Peer-Reviewed Original ResearchConceptsCoronary microvascular dysfunctionCoronary flow reserveCoronary artery diseaseChest painSymptomatic patientsArtery diseasePrimary outcomeEmergency departmentNonobstructive coronary artery diseaseRb-82 positron emission tomographyEffect of ranolazineRate-pressure productEmergency department patientsQTc-prolonging drugsRobust clinical trialsPositron emission tomographyHypertensive urgencyMicrovascular anginaMicrovascular dysfunctionUnderdiagnosed causeControlled TrialsDepartment patientsHeart failureAcute symptomsPressure product
2016
Protocol for three parallel multi-site stepped care effectiveness studies for unhealthy alcohol use in HIV-positive patients
Edelman EJ, Maisto SA, Hansen NB, Cutter CJ, Dziura J, Fiellin LE, O'Connor PG, Bedimo R, Gibert C, Marconi VC, Rimland D, Rodriguez-Barradas MC, Simberkoff MS, Justice AC, Bryant KJ, Fiellin DA. Protocol for three parallel multi-site stepped care effectiveness studies for unhealthy alcohol use in HIV-positive patients. Contemporary Clinical Trials 2016, 52: 80-90. PMID: 27876616, PMCID: PMC5253227, DOI: 10.1016/j.cct.2016.11.008.Peer-Reviewed Original ResearchConceptsUnhealthy alcohol useAlcohol use disorderHIV-positive patientsMotivational enhancement therapyAlcohol useWeek 12Risk drinkingWeek 4Effective evidence-based treatmentsInfectious disease clinicHIV-positive individualsModerate alcohol useEvidence-based treatmentsParticipants meeting criteriaImplementation of interventionsVACS IndexHIV careSecondary outcomesCare trialsDisease clinicHIV morbidityPrimary outcomeAlcohol pharmacotherapyInitial treatmentLiver disease
2014
Reversal of Early Abnormalities in Glucose Metabolism in Obese Youth: Results of an Intensive Lifestyle Randomized Controlled Trial
Savoye M, Caprio S, Dziura J, Camp A, Germain G, Summers C, Li F, Shaw M, Nowicka P, Kursawe R, DePourcq F, Kim G, Tamborlane WV. Reversal of Early Abnormalities in Glucose Metabolism in Obese Youth: Results of an Intensive Lifestyle Randomized Controlled Trial. Diabetes Care 2014, 37: 317-324. PMID: 24062325, PMCID: PMC3898759, DOI: 10.2337/dc13-1571.Peer-Reviewed Original ResearchConceptsStandard of careClinical careBlood glucoseObese adolescentsObese youthOral glucose tolerance test glucoseIntensive lifestyle modificationDiabetes Prevention ProgramStandard clinical careInsulin sensitivity indexHealthy lifestyle programType 2 diabetesRisk of T2DChildhood obesity epidemicΒ-cell dysfunctionLifestyle modificationControlled TrialsOGTT glucosePrimary outcomeGlucose toleranceInsulin resistanceLifestyle programAnthropometric assessmentEarly abnormalitiesGlucose levels