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 boardOutcomesTrialsAn Introduction and Practical Guide to Strategies for Analyzing Longitudinal Data in Clinical Trials of Smoking Cessation Treatment: Beyond Dichotomous Point-Prevalence Outcomes
Kypriotakis G, Bernstein S, Bold K, Dziura J, Hedeker D, Mermelstein R, Weinberger A. An Introduction and Practical Guide to Strategies for Analyzing Longitudinal Data in Clinical Trials of Smoking Cessation Treatment: Beyond Dichotomous Point-Prevalence Outcomes. Nicotine & Tobacco Research 2024, 26: 796-805. PMID: 38214037, PMCID: PMC11190044, DOI: 10.1093/ntr/ntae005.Peer-Reviewed Original ResearchSmoking cessation treatmentChronic relapsing conditionCessation treatmentRelapsing conditionSmoking cessation clinical trialMeasures of abstinenceTobacco useAbstinence outcomesTobacco dependence treatmentTobacco abstinenceTobacco dependenceTobacco outcomesDependence treatmentTreatment studiesAbstinenceSmoking cessationClinical trialsIntervention successParticipant enrollmentSociety for ResearchNicotineLongitudinal dataResearch NetworkRemitting natureAnalysis of data
2022
Effect of Implementation Facilitation to Promote Adoption of Medications for Addiction Treatment in US HIV Clinics
Edelman EJ, Gan G, Dziura J, Esserman D, Porter E, Becker WC, Chan PA, Cornman DH, Helfrich CD, Reynolds J, Yager JE, Morford KL, Muvvala SB, Fiellin DA. Effect of Implementation Facilitation to Promote Adoption of Medications for Addiction Treatment in US HIV Clinics. JAMA Network Open 2022, 5: e2236904. PMID: 36251291, PMCID: PMC9577676, DOI: 10.1001/jamanetworkopen.2022.36904.Peer-Reviewed Original ResearchConceptsTobacco use disorderHIV clinicOpioid use disorderUse disordersAlcohol use disorderAddiction treatmentControl periodImplementation facilitationAdoption of medicationsMulticomponent implementation strategyProvision of MOUDUS HIV clinicsMaintenance periodElectronic health record dataHealth record dataEvaluation periodAdult patientsMean ageClinical trialsMAIN OUTCOMEClinicMOUDPatientsDisordersPatient incentivesConcomitant medication use in children with autism spectrum disorder: Data from the Autism Biomarkers Consortium for Clinical Trials
Shurtz L, Schwartz C, DiStefano C, McPartland JC, Levin AR, Dawson G, Kleinhans NM, Faja S, Webb SJ, Shic F, Naples AJ, Seow H, Bernier RA, Chawarska K, Sugar CA, Dziura J, Senturk D, Santhosh M, Jeste SS. Concomitant medication use in children with autism spectrum disorder: Data from the Autism Biomarkers Consortium for Clinical Trials. Autism 2022, 27: 952-966. PMID: 36086805, PMCID: PMC9995606, DOI: 10.1177/13623613221121425.Peer-Reviewed Original ResearchConceptsConcomitant psychotropic medicationsPsychotropic medicationsClinical trialsMedication useSchool-aged childrenClinical representativenessSelective serotonin reuptake inhibitorsConcomitant medication useVariety of medicationsAutism spectrum disorderSerotonin reuptake inhibitorsPsychotropic medication useNew treatment optionsGreater overall impairmentCentral nervous systemSpectrum disorderMedication classesReuptake inhibitorsAlpha agonistsTreatment optionsClinical endpointsInclusion criteriaStudy populationMedicationsNervous systemPatterns of intervention utilization among school-aged children on the autism spectrum: Findings from a multi-site research consortium
Sridhar A, Kuhn J, Faja S, Sabatos-DeVito M, Nikolaeva JI, Dawson G, Nelson CA, Webb SJ, Bernier R, Jeste S, Chawarska K, Sugar CA, Shic F, Naples A, Dziura J, McPartland JC, Consortium T. Patterns of intervention utilization among school-aged children on the autism spectrum: Findings from a multi-site research consortium. Research In Autism Spectrum Disorders 2022, 94: 101950. PMID: 35444715, PMCID: PMC9015686, DOI: 10.1016/j.rasd.2022.101950.Peer-Reviewed Original ResearchAutism spectrumSchool-aged childrenSymptom levelsCognitive abilitiesClinical trialsLower cognitive abilityHours of interventionHigher parental education levelPart of standardIntervention hoursVariety of interventionsAmount of interventionConcurrent treatmentService utilizationParental education levelIntervention utilizationEmpirical supportMulti-site studyParent educationIntervention servicesMost childrenFuture researchInterventionChildrenResearch Consortium
2021
Impact 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 cliniciansA Brief Negotiation Interview Adherence Scale for Smoking Cessation: A psychometric evaluation
Pantalon MV, Dziura J, Li FY, D'Onofrio G, Weiss J, Bernstein SL. A Brief Negotiation Interview Adherence Scale for Smoking Cessation: A psychometric evaluation. Journal Of Substance Use And Addiction Treatment 2021, 126: 108398. PMID: 34116807, DOI: 10.1016/j.jsat.2021.108398.Peer-Reviewed Original ResearchConceptsBrief Negotiation InterviewNicotine replacement therapySmoking cessationAdherence ScaleQuitline referralHigh-risk alcohol consumptionOpioid use disorderPsychometric propertiesReplacement therapyEmergency departmentExcellent internal consistencyTobacco abstinenceClinical trialsInter-rater reliabilityUse disordersAlcohol consumptionPsychometric evaluationCessationFactor 1Behavioral contractingDiscriminant validityFactor 2Independent ratersPredictive validityInternal consistencyThe 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
Validating Self‐Reported Unhealthy Alcohol Use With Phosphatidylethanol (PEth) Among Patients With HIV
Eyawo O, Deng Y, Dziura J, Justice AC, McGinnis K, Tate JP, Rodriguez‐Barradas M, Hansen NB, Maisto SA, Marconi VC, O’Connor P, Bryant K, Fiellin DA, Edelman EJ. Validating Self‐Reported Unhealthy Alcohol Use With Phosphatidylethanol (PEth) Among Patients With HIV. Alcohol Clinical And Experimental Research 2020, 44: 2053-2063. PMID: 33460225, PMCID: PMC8856627, DOI: 10.1111/acer.14435.Peer-Reviewed Original ResearchConceptsUnhealthy alcohol useSignificant alcohol useHeavy drinking daysAlcohol use disorderTimeline FollowbackAlcohol useSelf-reported alcohol useNumber of drinksClinical trialsRisk drinkingUse disordersDrinking daysBiomarker-based evidenceSample of PWHDrinks/dayMean numberSelf-reported alcohol consumptionMagnitude of associationBlood spot samplesLiver diseasePEth levelsTLFB interviewAlcohol consumptionLogistic regressionPatientsQuality 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 ResearchConceptsClinical 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
2017
Tobacco dependence treatment in the emergency department: A randomized trial using the Multiphase Optimization Strategy
Bernstein SL, Dziura J, Weiss J, Miller T, Vickerman KA, Grau LE, Pantalon MV, Abroms L, Collins LM, Toll B. Tobacco dependence treatment in the emergency department: A randomized trial using the Multiphase Optimization Strategy. Contemporary Clinical Trials 2017, 66: 1-8. PMID: 29287665, PMCID: PMC5851600, DOI: 10.1016/j.cct.2017.12.016.Peer-Reviewed Original ResearchMeSH KeywordsAdultCost-Benefit AnalysisEmergency Service, HospitalFemaleHotlinesHumansMaleMiddle AgedMotivational InterviewingNicotine Chewing GumQualitative ResearchQuality-Adjusted Life YearsReferral and ConsultationSmoking CessationSmoking Cessation AgentsText MessagingTobacco Use Cessation DevicesTobacco Use DisorderTransdermal PatchTreatment OutcomeUnited StatesConceptsExhaled carbon monoxideHospital emergency departmentEmergency departmentMultiphase optimization strategyTobacco dependenceSubsequent confirmatory trialTobacco dependence interventionsNicotine replacement therapyTobacco dependence treatmentRecent clinical trialsLower socioeconomic groupsCost-effectiveness analysisPrimary endpointED patientsInitial treatmentStudy enrollmentTelephone quitlinesClinical efficacyPreventable causeReplacement therapyFuture trialsDependence treatmentTobacco abstinenceClinical trialsMulticomponent intervention
2015
Extended-Release Guanfacine for Hyperactivity in Children With Autism Spectrum Disorder
Scahill L, McCracken JT, King BH, Rockhill C, Shah B, Politte L, Sanders R, Minjarez M, Cowen J, Mullett J, Page C, Ward D, Deng Y, Loo S, Dziura J, McDougle CJ. Extended-Release Guanfacine for Hyperactivity in Children With Autism Spectrum Disorder. American Journal Of Psychiatry 2015, 172: 1197-1206. PMID: 26315981, DOI: 10.1176/appi.ajp.2015.15010055.Peer-Reviewed Original ResearchConceptsExtended-release guanfacineModal doseGuanfacine groupWeek 8Common adverse eventsAutism spectrum disorderWeeks of treatmentAttention deficit hyperactivity disorderDeficit hyperactivity disorderPlacebo groupAdverse eventsBlood pressurePlacebo subjectsClinical trialsSpectrum disorderPlaceboGuanfacineHyperactivityPulse rateHyperactivity disorderGroup differencesMotor planningWeeksBrief cognitive batteryDisordersEffect 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
2014
Using Multiple Daily Pain Ratings to Improve Reliability and Assay Sensitivity: How Many Is Enough?
Heapy A, Dziura J, Buta E, Goulet J, Kulas JF, Kerns RD. Using Multiple Daily Pain Ratings to Improve Reliability and Assay Sensitivity: How Many Is Enough? Journal Of Pain 2014, 15: 1360-1365. PMID: 25283469, DOI: 10.1016/j.jpain.2014.09.012.Peer-Reviewed Original ResearchConceptsPain intensity ratingsPain treatment trialsPain ratingsTreatment trialsIntensity ratingsDaily pain ratingsMedical Center patientsIMMPACT recommendationsBaseline measurement periodCenter patientsPain assessmentBland-Altman analysisClinical trialsSecondary data analysisDaily callsDaily ratingsTrialsMeaningful differencesAssay sensitivityMeasure reliabilityAdequate reliabilitySpecific recommendationsPatientsSmall subsetBaselineEthyl Glucuronide and Ethyl Sulfate Assays in Clinical Trials, Interpretation, and Limitations: Results of a Dose Ranging Alcohol Challenge Study and 2 Clinical Trials
Jatlow PI, Agro A, Wu R, Nadim H, Toll BA, Ralevski E, Nogueira C, Shi J, Dziura JD, Petrakis IL, O'Malley SS. Ethyl Glucuronide and Ethyl Sulfate Assays in Clinical Trials, Interpretation, and Limitations: Results of a Dose Ranging Alcohol Challenge Study and 2 Clinical Trials. Alcohol Clinical And Experimental Research 2014, 38: 2056-2065. PMID: 24773137, PMCID: PMC4107122, DOI: 10.1111/acer.12407.Peer-Reviewed Original ResearchConceptsEtG/EtSClinical trialsEthyl glucuronideRecent alcohol consumptionEvaluation of outcomesAlcohol challenge studyBlood concentrationsAlcohol dosesLow doseLight drinkingAlcohol consumptionChallenge studiesCutoff concentrationDrinking historyTimed intervalsAbstinenceTrialsHeavy consumptionDrinkingDoseGlucuronideObjective measuresHoursCutoffEtG
2011
Comparative Effectiveness of Ventral vs Dorsal Surgery for Cervical Spondylotic Myelopathy
Ghogawala Z, Martin B, Benzel EC, Dziura J, Magge SN, Abbed KM, Bisson EF, Shahid J, Coumans JV, Choudhri TF, Steinmetz MP, Krishnaney AA, King JT, Butler WE, Barker FG, Heary RF. Comparative Effectiveness of Ventral vs Dorsal Surgery for Cervical Spondylotic Myelopathy. Neurosurgery 2011, 68: 622-631. PMID: 21164373, DOI: 10.1227/neu.0b013e31820777cf.Peer-Reviewed Original ResearchConceptsCervical spondylotic myelopathyFusion surgeryVentral surgeryHospital staySpondylotic myelopathyHR-QOLClinical trialsHospital costsDegenerative cervical spondylotic myelopathyJapanese Orthopaedic Association scale scoreModified Japanese Orthopaedic Association scale scorePilot studyHR-QOL improvementMean hospital costDisease-specific symptomsHealth-related qualityClinical pilot trialPatients age 40Spinal cord dysfunctionHigher hospital costsRandomized clinical trialsDorsal surgeryBaseline demographicsComplication rateCord dysfunction
2009
Medication and Parent Training in Children With Pervasive Developmental Disorders and Serious Behavior Problems: Results From a Randomized Clinical Trial
Aman MG, Mcdougle CJ, Scahill L, Handen B, Arnold LE, Johnson C, Stigler KA, Bearss K, Butter E, Swiezy NB, Sukhodolsky DD, Ramadan Y, Pozdol SL, Nikolov R, Lecavalier L, Kohn AE, Koenig K, Hollway JA, Korzekwa P, Gavaletz A, Mulick JA, Hall KL, Dziura J, Ritz L, Trollinger S, Yu S, Vitiello B, Wagner A, Network F. Medication and Parent Training in Children With Pervasive Developmental Disorders and Serious Behavior Problems: Results From a Randomized Clinical Trial. Journal Of The American Academy Of Child & Adolescent Psychiatry 2009, 48: 1143-1154. PMID: 19858761, PMCID: PMC3142923, DOI: 10.1097/chi.0b013e3181bfd669.Peer-Reviewed Original ResearchConceptsPervasive developmental disorderClinical trialsClinical Global Impressions-Improvement scoreAberrant Behavior Checklist IrritabilityParallel-group clinical trialParent trainingBehavioral problemsDevelopmental disordersRisperidone doseRisperidone monotherapyHyperactivity/noncompliance subscaleSevere behavioral problemsCOMB groupPT sessionsQuestionnaire scoresHSQ scoresMedicationsGreater reductionChildrenPrimary measureRisperidoneSignificant reductionStereotypic behaviorScoresDoseA comparison of neurocognitive functioning in children previously randomized to dexamethasone or prednisone in the treatment of childhood acute lymphoblastic leukemia
Kadan-Lottick NS, Brouwers P, Breiger D, Kaleita T, Dziura J, Liu H, Chen L, Nicoletti M, Stork L, Bostrom B, Neglia JP. A comparison of neurocognitive functioning in children previously randomized to dexamethasone or prednisone in the treatment of childhood acute lymphoblastic leukemia. Blood 2009, 114: 1746-1752. PMID: 19546477, PMCID: PMC2738566, DOI: 10.1182/blood-2008-12-186502.Peer-Reviewed Original ResearchConceptsAcute lymphoblastic leukemiaChildhood acute lymphoblastic leukemiaDexamethasone groupLymphoblastic leukemiaNeurocognitive functioningHigher event-free survival rateEvent-free survival rateCentral nervous system penetrationLong-term cognitive functioningPsychotropic drug usePrevious clinical trialsWorse neurocognitive functioningCorticosteroid RandomizationNeurocognitive toxicityPrednisone groupNeurologic complicationsClinical trialsSignificant overall differenceSurvival rateDrug useYounger ageWorse functioningOlder ageDiagnosisMultisite study
2008
Effect of a Successful Intensive Lifestyle Program on Insulin Sensitivity and Glucose Tolerance in Obese Youth
Shaw M, Savoye M, Cali A, Dziura J, Tamborlane WV, Caprio S. Effect of a Successful Intensive Lifestyle Program on Insulin Sensitivity and Glucose Tolerance in Obese Youth. Diabetes Care 2008, 32: 45-47. PMID: 18840769, PMCID: PMC2606827, DOI: 10.2337/dc08-0808.Peer-Reviewed Original ResearchConceptsIntensive lifestyle programLifestyle programInsulin sensitivityObese youthBody fatGlucose metabolismLarge randomized clinical trialsOral glucose tolerance testGlucose tolerance testRandomized clinical trialsGlucose toleranceObese childrenControl subjectsTolerance testClinical trialsBody compositionBody weightSubject changesGreater decreaseSubjectsFatMetabolismBMIResearch designBright bodies