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 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 boardScreening, brief intervention, and referral to treatment for pain management for veterans separating from military service: study protocol of a hybrid type 2 study testing implementation facilitation versus training-as-usual
Sellinger J, Rosen M, Lazar C, Gilstad-Hayden K, Dziura J, Li F, Mattocks K, Weede A, Sullivan-Tibbs M, Rose L, Vassallo G, Manhapra A, Turner A, Vogt D, Woodward E, Hartmann C, Haskell S, Mohammad A, Martino S. Screening, brief intervention, and referral to treatment for pain management for veterans separating from military service: study protocol of a hybrid type 2 study testing implementation facilitation versus training-as-usual. Pain Medicine 2024, 25: s99-s106. PMID: 39514877, DOI: 10.1093/pm/pnae062.Peer-Reviewed Original ResearchConceptsTraining-as-usualImplementation facilitatorsReferral to treatmentCase managementBrief interventionHybrid type 2 effectiveness-implementation trialPain managementImplementation strategiesPrimary implementation outcomeSubstance misuseProportion of participantsPain careUsefulness of screeningVeteran engagementVA sitesImplementation outcomesPragmatic trialPain serviceVeteran participantsCase management systemPain intensityDischarged veteransStudy enrollmentVeteransChronic painExtended-Release 7-Day Injectable Buprenorphine for Patients With Minimal to Mild Opioid Withdrawal
D’Onofrio G, Herring A, Perrone J, Hawk K, Samuels E, Cowan E, Anderson E, McCormack R, Huntley K, Owens P, Martel S, Schactman M, Lofwall M, Walsh S, Dziura J, Fiellin D. Extended-Release 7-Day Injectable Buprenorphine for Patients With Minimal to Mild Opioid Withdrawal. JAMA Network Open 2024, 7: e2420702. PMID: 38976265, PMCID: PMC11231806, DOI: 10.1001/jamanetworkopen.2024.20702.Peer-Reviewed Original ResearchConceptsClinical Opiate Withdrawal ScaleExtended-release buprenorphineOpioid use disorderPrecipitated withdrawalOpioid withdrawalOpioid use disorder treatmentCow scoreClinical Opiate Withdrawal Scale scoreAdverse eventsNonrandomized trialsSevere opioid use disorderDays of opioid useOpiate Withdrawal ScaleModerate to severe opioid use disorderFormulation of buprenorphineOpioid use disorder careWithdrawal ScaleUse disorderAssociated with medicationsNonprescribed opioidsPain scoresExtended-releaseInjection painOpioid useAdult patientsFormative 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
2023
Effect of a Home Health and Safety Intervention on Emergency Department Use in the Frail Elderly: A Prospective Observational Study
Bogucki S, Siddiqui G, Carter R, McGovern J, Dziura J, Gan G, Li F, Stover G, Cone D, Brokowski C, Joseph D. Effect of a Home Health and Safety Intervention on Emergency Department Use in the Frail Elderly: A Prospective Observational Study. Western Journal Of Emergency Medicine 2023, 0: 522-531. PMID: 37278776, PMCID: PMC10284516, DOI: 10.5811/westjem.58378.Peer-Reviewed Original ResearchConceptsProspective observational studyED utilizationObservational studySubsequent ED utilizationEmergency department useEmergency department utilizationHome health nursesOutcomes of interestHome health programsLimited statistical powerSubsequent EDED evaluationStudy armsGeriatric patientsDepartment useHealth nursesFall riskStudy interventionHome visitsHome healthFrail ElderlyCognitive declineUseful markerHealth programsFrailty
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 systemGender Differences in Guideline-Directed Medical Therapy for Cardiovascular Disease Among Young Veterans
Dhruva SS, Dziura J, Bathulapalli H, Rosman L, Gaffey AE, Davis MB, Brandt CA, Haskell SG. Gender Differences in Guideline-Directed Medical Therapy for Cardiovascular Disease Among Young Veterans. Journal Of General Internal Medicine 2022, 37: 806-815. PMID: 36042086, PMCID: PMC9481764, DOI: 10.1007/s11606-022-07595-1.Peer-Reviewed Original ResearchConceptsGuideline-directed medical therapyIncident coronary artery diseaseCoronary artery diseaseHeart failureMedical therapyCardiovascular diseaseWomen veteransDiagnosis of HFAldosterone system inhibitorsIncident heart failureAdverse cardiovascular outcomesClinical practice guidelinesRisk of mortalityLevel of evidenceYounger women veteransHF medicationsMultiple pharmacotherapiesAntiplatelet therapyCardiovascular outcomesYounger average ageArtery diseaseCVD careGuideline recommendationsSystem inhibitorsAdverse outcomesThe Autism Biomarkers Consortium for Clinical Trials: Initial Evaluation of a Battery of Candidate EEG Biomarkers
Webb SJ, Naples AJ, Levin AR, Hellemann G, Borland H, Benton J, Carlos C, McAllister T, Santhosh M, Seow H, Atyabi A, Bernier R, Chawarska K, Dawson G, Dziura J, Faja S, Jeste S, Murias M, Nelson CA, Sabatos-DeVito M, Senturk D, Shic F, Sugar CA, McPartland JC. The Autism Biomarkers Consortium for Clinical Trials: Initial Evaluation of a Battery of Candidate EEG Biomarkers. American Journal Of Psychiatry 2022, 180: 41-49. PMID: 36000217, PMCID: PMC10027395, DOI: 10.1176/appi.ajp.21050485.Peer-Reviewed Original ResearchConceptsBiological motion perceptionAutism spectrum disorderResting-state activityMotion perceptionEEG biomarkersGroup discriminationPsychometric propertiesBasic psychometric propertiesASD groupASD diagnosisNeural responsesSpectrum disorderAlpha powerN170Naturalistic studyPerceptionMixed resultsTask latencyVEP amplitudeContext of useLimited attentionInconsistent resultsAcquisition rateDiscriminationBatteriesMilitary sexual trauma and incident hypertension: a 16-year cohort study of young and middle-aged men and women
Gaffey AE, Rosman L, Sico JJ, Haskell SG, Brandt CA, Bathulapalli H, Han L, Dziura J, Skanderson M, Burg MM. Military sexual trauma and incident hypertension: a 16-year cohort study of young and middle-aged men and women. Journal Of Hypertension 2022, 40: 2307-2315. PMID: 35983872, DOI: 10.1097/hjh.0000000000003267.Peer-Reviewed Original ResearchConceptsIncident hypertensionRisk factorsPsychiatric disordersMultivariate Cox proportional hazards modelVeterans Health Administration dataGreater riskCox proportional hazards modelTrauma-related psychiatric disordersMiddle-aged veteransCardiovascular risk factorsBaseline blood pressureElevated cardiovascular riskLarge prospective cohortHealth Administration dataMiddle-aged menProportional hazards modelSex-specific analysesPosttraumatic stress disorderMilitary sexual traumaCardiovascular riskCohort studyProspective cohortBlood pressureTreatment attenuatesCardiovascular impactEffect of the STRIDE fall injury prevention intervention on falls, fall injuries, and health‐related quality of life
Ganz DA, Yuan AH, Greene EJ, Latham NK, Araujo K, Siu AL, Magaziner J, Gurwitz JH, Wu AW, Alexander NB, Wallace RB, Greenspan SL, Rich J, Volpi E, Waring SC, Dykes PC, Ko F, Resnick NM, McMahon SK, Basaria S, Wang R, Lu C, Esserman D, Dziura J, Miller ME, Travison TG, Peduzzi P, Bhasin S, Reuben DB, Gill TM. Effect of the STRIDE fall injury prevention intervention on falls, fall injuries, and health‐related quality of life. Journal Of The American Geriatrics Society 2022, 70: 3221-3229. PMID: 35932279, PMCID: PMC9669115, DOI: 10.1111/jgs.17964.Peer-Reviewed Original ResearchConceptsHealth-related qualityHospital admissionEQ-5DMedical attentionLeast square mean changeFall injury riskSelf-reported fracturesFall-related fracturesFall-related outcomesIncidence rate ratiosInjury prevention interventionsPrimary care practicesReal-world effectivenessFall prevention studiesMeaningful clinical effectsGOV IDENTIFIERUsual careMultifactorial interventionClinical effectsEQ-VASPrevention StudyFall injuriesOlder adults ageMean changePrevention interventionsUser centered clinical decision support to implement initiation of buprenorphine for opioid use disorder in the emergency department: EMBED pragmatic cluster randomized controlled trial
Melnick ER, Nath B, Dziura JD, Casey MF, Jeffery MM, Paek H, Soares WE, Hoppe JA, Rajeevan H, Li F, Skains RM, Walter LA, Patel MD, Chari SV, Platts-Mills TF, Hess EP, D'Onofrio G. User centered clinical decision support to implement initiation of buprenorphine for opioid use disorder in the emergency department: EMBED pragmatic cluster randomized controlled trial. The BMJ 2022, 377: e069271. PMID: 35760423, PMCID: PMC9231533, DOI: 10.1136/bmj-2021-069271.Peer-Reviewed Original ResearchConceptsOpioid use disorderUsual care armEmergency departmentUse disordersCare armPragmatic clusterClinical decision supportIntervention armRoutine emergency careSecondary implementation outcomesSeverity of withdrawalTertiary care centerClinical decision support toolInitiation of buprenorphineElectronic health record tasksElectronic health record workflowsRE-AIM frameworkElectronic health record platformsHealth record platformsClinical decision support systemElectronic health recordsVisit documentationTreatment of addictionUsual careAdult patientsAttention Allocation During Exploration of Visual Arrays in ASD: Results from the ABC-CT Feasibility Study
Tsang T, Naples AJ, Barney EC, Xie M, Bernier R, Dawson G, Dziura J, Faja S, Jeste SS, McPartland JC, Nelson CA, Murias M, Seow H, Sugar C, Webb SJ, Shic F, Johnson SP. Attention Allocation During Exploration of Visual Arrays in ASD: Results from the ABC-CT Feasibility Study. Journal Of Autism And Developmental Disorders 2022, 53: 3220-3229. PMID: 35657448, PMCID: PMC10980886, DOI: 10.1007/s10803-022-05569-0.Peer-Reviewed Original ResearchConceptsExploration paradigmNonsocial stimuliAttention allocationASD groupSocial stimuliTD childrenVisual arrayCognitive skillsObject arraysTypical developmentASDVisual explorationObjective measuresStimuliParadigmChildrenFaceSalienceSkillsRecent workLess timeAttentionMeasuresQuantifying featuresObjectsPractices, attitudes, and confidence related to tobacco treatment interventions in HIV clinics: a multisite cross-sectional survey
Bold KW, Deng Y, Dziura J, Porter E, Sigel KM, Yager JE, Ledgerwood DM, Bernstein SL, Edelman EJ. Practices, attitudes, and confidence related to tobacco treatment interventions in HIV clinics: a multisite cross-sectional survey. Translational Behavioral Medicine 2022, 12: 726-733. PMID: 35608982, PMCID: PMC9260059, DOI: 10.1093/tbm/ibac022.Peer-Reviewed Original ResearchConceptsTobacco use disorderHIV clinicHIV cliniciansExact testBrief smoking cessation interventionMultisite cross-sectional surveyHIV clinic settingFirst-line medicationImpact of smokingMedication side effectsClinical practice guidelinesSmoking cessation interventionTobacco treatment interventionsFisher's exact testCross-sectional surveyProvision of careChi-square testAntiretroviral treatmentCounseling patientsTobacco treatmentCessation interventionsClinic settingPractice guidelinesTobacco useProvider characteristicsImproving patient and clinician safety during COVID-19 through rapidly adaptive simulation and a randomised controlled trial: a study protocol
Evans LV, Ray JM, Bonz JW, Joseph M, Gerwin JN, Dziura JD, Venkatesh AK, Wong AH. Improving patient and clinician safety during COVID-19 through rapidly adaptive simulation and a randomised controlled trial: a study protocol. BMJ Open 2022, 12: e058980. PMID: 35589358, PMCID: PMC9121107, DOI: 10.1136/bmjopen-2021-058980.Peer-Reviewed Original ResearchConceptsRandomised controlled trialsEmergency departmentPhysician stressEmergency physiciansClinician safetySemi-structured qualitative interviewsReturn to the emergency departmentControlled trialsNon-COVID-19-related illnessesState-Trait Anxiety InventoryPersonal safety concernsIncreased work burdenCOVID-19 preparednessUp-to-date careThreat to patientsVirtual telesimulationClinician stressPreparedness interventionsPhysician preparednessHospital administratorsLonger-term outcomesHuman Investigation CommitteeSimulation interventionSimulation educationDissemination effortsThe Autism Biomarkers Consortium for Clinical Trials: evaluation of a battery of candidate eye-tracking biomarkers for use in autism clinical trials
Shic F, Naples AJ, Barney EC, Chang SA, Li B, McAllister T, Kim M, Dommer KJ, Hasselmo S, Atyabi A, Wang Q, Helleman G, Levin AR, Seow H, Bernier R, Charwaska K, Dawson G, Dziura J, Faja S, Jeste SS, Johnson SP, Murias M, Nelson CA, Sabatos-DeVito M, Senturk D, Sugar CA, Webb SJ, McPartland JC. The Autism Biomarkers Consortium for Clinical Trials: evaluation of a battery of candidate eye-tracking biomarkers for use in autism clinical trials. Molecular Autism 2022, 13: 15. PMID: 35313957, PMCID: PMC10124777, DOI: 10.1186/s13229-021-00482-2.Peer-Reviewed Original ResearchConceptsAutism spectrum disorderBiological motion preferenceSocial interactiveHuman faceMotion preferencesAutism symptom severityPragmatic communication skillsHigher verbal IQAttentional processesASD groupScene tasksVerbal IQTypical developmentSocial scenesSpectrum disorderOculomotor indicesReflex taskStandardized contextEye movementsCommunication skillsConstruct validitySymptom severityTaskPsychiatric conditionsSpecific interventionsAssociation of renalase with clinical outcomes in hospitalized patients with COVID-19
Safdar B, Wang M, Guo X, Cha C, Chun HJ, Deng Y, Dziura J, El-Khoury JM, Gorelick F, Ko AI, Lee AI, Safirstein R, Simonov M, Zhou B, Desir GV. Association of renalase with clinical outcomes in hospitalized patients with COVID-19. PLOS ONE 2022, 17: e0264178. PMID: 35259186, PMCID: PMC8903289, DOI: 10.1371/journal.pone.0264178.Peer-Reviewed Original ResearchConceptsCOVID-19 patientsRenalase levelsIntensive care unit admissionHospitalized COVID-19 patientsMean age 64 yearsCOVID-19Cox proportional hazards modelCare unit admissionPrimary composite outcomeRetrospective cohort studyUse of vasopressorsSevere COVID-19IL-6 levelsAge 64 yearsRisk of deathCOVID-19 subjectsInitial disease severityProportional hazards modelCOVID-19 diseasePlasma renalaseUnit admissionICU admissionCohort studyComposite outcomeCytokine levelsMapping the complex causal mechanisms of drinking and driving behaviors among adolescents and young adults
Hosseinichimeh N, MacDonald R, Li K, Fell JC, Haynie DL, Simons-Morton B, Banz BC, Camenga DR, Iannotti RJ, Curry LA, Dziura J, Mayes LC, Andersen DF, Vaca FE. Mapping the complex causal mechanisms of drinking and driving behaviors among adolescents and young adults. Social Science & Medicine 2022, 296: 114732. PMID: 35078103, PMCID: PMC8925313, DOI: 10.1016/j.socscimed.2022.114732.Peer-Reviewed Original Research