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
A 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 study
2020
Interrupted 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
Sudden cardiac arrest survival in HEARTSafe communities
Cone DC, Burns K, Maciejewski K, Dziura J, McNally B, Vellano K, Group T. Sudden cardiac arrest survival in HEARTSafe communities. Resuscitation 2019, 146: 13-18. PMID: 31705910, DOI: 10.1016/j.resuscitation.2019.10.029.Peer-Reviewed Original ResearchUser-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 boardBuprenorphine
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 adolescentsIntervention
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
2015
Effect of Parent Training vs Parent Education on Behavioral Problems in Children With Autism Spectrum Disorder: A Randomized Clinical Trial
Bearss K, Johnson C, Smith T, Lecavalier L, Swiezy N, Aman M, McAdam DB, Butter E, Stillitano C, Minshawi N, Sukhodolsky DG, Mruzek DW, Turner K, Neal T, Hallett V, Mulick JA, Green B, Handen B, Deng Y, Dziura J, Scahill L. Effect of Parent Training vs Parent Education on Behavioral Problems in Children With Autism Spectrum Disorder: A Randomized Clinical Trial. JAMA 2015, 313: 1524-1533. PMID: 25898050, PMCID: PMC9078140, DOI: 10.1001/jama.2015.3150.Peer-Reviewed Original ResearchConceptsAberrant Behavior Checklist-Irritability subscaleClinical Global Impressions-Improvement scaleParent trainingCo-primary outcomesAutism spectrum disorderClinical Global ImpressionSpectrum disorderDisruptive behaviorParent-reported outcomesParent educationPositive responseClinical improvementSecondary outcomesWeek 24Global ImpressionBlinded cliniciansClinical trialsClinical significanceMAIN OUTCOMEImprovement ScaleGreater severityTreatment assignment
2013
Effects of Fructose vs Glucose on Regional Cerebral Blood Flow in Brain Regions Involved With Appetite and Reward Pathways
Page KA, Chan O, Arora J, Belfort-DeAguiar R, Dzuira J, Roehmholdt B, Cline GW, Naik S, Sinha R, Constable RT, Sherwin RS. Effects of Fructose vs Glucose on Regional Cerebral Blood Flow in Brain Regions Involved With Appetite and Reward Pathways. JAMA 2013, 309: 63-70. PMID: 23280226, PMCID: PMC4076145, DOI: 10.1001/jama.2012.116975.Peer-Reviewed Original ResearchConceptsRegional cerebral blood flowCerebral blood flowGlucose ingestionFructose ingestionFructose consumptionBlood flowGlucagon-like polypeptide-1Weight gainRegional CBF changesPrevalence of obesityHigh-fructose dietHealthy adult volunteersLower peak levelsConsumption of fructoseMagnetic resonance imaging sessionPosterior cingulate cortexWhole-brain analysisEffects of fructoseFunctional connectivity analysisSatiety hormonesSecondary outcomesDrink ingestionSystemic glucoseVoxel-level analysisInsulin resistance