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 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 boardIntegrated stepped alcohol treatment with contingency management for unhealthy alcohol use among people with HIV: A randomized controlled trial.
Edelman E, Dziura J, Deng Y, DePhilippis D, Ferguson T, Brown S, Marconi V, Goetz M, Rodriguez-Barradas M, Simberkoff M, Molina P, Weintrob A, Maisto S, Paris M, Justice A, Bryant K, Fiellin D. Integrated stepped alcohol treatment with contingency management for unhealthy alcohol use among people with HIV: A randomized controlled trial. JAIDS Journal Of Acquired Immune Deficiency Syndromes 2024 PMID: 39321757, DOI: 10.1097/qai.0000000000003534.Peer-Reviewed Original ResearchUnhealthy alcohol useSelf-reported abstinenceAlcohol useLost to follow-upContingency managementAlcohol use disorderRandomized controlled trialsSubstance use treatmentAlcohol abstinenceFollow-upUse disorderControlled trialsPWHAlcohol treatmentAbstinenceUse treatmentEvidence of abstinenceHIVWeeksMean proportionTreatmentTrialsAlcoholDaysParticipants
2020
Integrated stepped alcohol treatment for patients with HIV and at-risk alcohol use: a randomized trial
Edelman EJ, Maisto SA, Hansen NB, Cutter CJ, Dziura J, Deng Y, Fiellin LE, O’Connor P, 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 at-risk alcohol use: a randomized trial. Addiction Science & Clinical Practice 2020, 15: 28. PMID: 32727618, PMCID: PMC7388231, DOI: 10.1186/s13722-020-00200-y.Peer-Reviewed Original ResearchConceptsRisk alcohol useAlcohol useAlcohol treatmentHealth of patientsEvidence-based strategiesWeek 24HIV outcomesRoutine careTelephone boosterPhysician managementEnhancement therapyHIVPWHPatientsTrialsTarget populationTreatmentAlcohol-related researchMulti-pronged approachOutcomesParticipantsInsufficient numberTherapyPopulationMethodsInQuality 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
2019
Integrated stepped alcohol treatment for patients with HIV and liver disease: A randomized 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 liver disease: A randomized trial. Journal Of Substance Use And Addiction Treatment 2019, 106: 97-106. PMID: 31540617, PMCID: PMC7244228, DOI: 10.1016/j.jsat.2019.08.007.Peer-Reviewed Original ResearchFeasibility 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 rateTrials
2017
Corrigendum to “The Starting Treatment for Ethanol in Primary care Trials (STEP Trials): Protocol for three parallel multi-site stepped care effectiveness studies for unhealthy alcohol use in HIV-positive patients” [Contemp. Clin. Trials 52 (2017) 80–90]
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. Corrigendum to “The Starting Treatment for Ethanol in Primary care Trials (STEP Trials): Protocol for three parallel multi-site stepped care effectiveness studies for unhealthy alcohol use in HIV-positive patients” [Contemp. Clin. Trials 52 (2017) 80–90]. Contemporary Clinical Trials 2017, 60: 125. PMID: 28712767, DOI: 10.1016/j.cct.2017.06.016.Peer-Reviewed Case Reports and Technical Notes
2016
Randomized controlled trials for degenerative lumbar spondylolisthesis: which patients benefit from lumbar fusion?
Ghogawala Z, Resnick DK, Glassman SD, Dziura J, Shaffrey CI, Mummaneni PV. Randomized controlled trials for degenerative lumbar spondylolisthesis: which patients benefit from lumbar fusion? Journal Of Neurosurgery Spine 2016, 26: 260-266. PMID: 27661562, DOI: 10.3171/2016.8.spine16716.Peer-Reviewed Original Research
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 measuresHoursCutoffEtGMeta-analysis of Protocolized Goal-Directed Hemodynamic Optimization for the Management of Severe Sepsis and Septic Shock in the Emergency Department
Wira CR, Dodge K, Sather J, Dziura J. Meta-analysis of Protocolized Goal-Directed Hemodynamic Optimization for the Management of Severe Sepsis and Septic Shock in the Emergency Department. Western Journal Of Emergency Medicine 2014, 15: 51-59. PMID: 24696750, PMCID: PMC3952890, DOI: 10.5811/westjem.2013.7.6828.Peer-Reviewed Original Research
2013
Detecting a clinically meaningful change in tic severity in Tourette syndrome: A comparison of three methods
Jeon S, Walkup JT, Woods DW, Peterson A, Piacentini J, Wilhelm S, Katsovich L, McGuire JF, Dziura J, Scahill L. Detecting a clinically meaningful change in tic severity in Tourette syndrome: A comparison of three methods. Contemporary Clinical Trials 2013, 36: 414-420. PMID: 24001701, PMCID: PMC3999642, DOI: 10.1016/j.cct.2013.08.012.Peer-Reviewed Original ResearchConceptsOdds ratioTourette syndromeYGTSS total tic scoreChronic tic disorderPositive treatment responsePositive responseTic scoreTic disordersTreatment responseTic severityTreatment assignmentBehavioral treatmentSignal detection analysisBehavioral interventionsSyndromeCGICategorical measuresTrialsMeaningful changeSeverityPercent reductionOptimal sensitivityDimensional measuresResponse
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
2009
Effects of coping skills training in school‐age children with type 1 diabetes
Grey M, Whittemore R, Jaser S, Ambrosino J, Lindemann E, Liberti L, Northrup V, Dziura J. Effects of coping skills training in school‐age children with type 1 diabetes. Research In Nursing & Health 2009, 32: 405-418. PMID: 19488997, PMCID: PMC2720049, DOI: 10.1002/nur.20336.Peer-Reviewed Original Research
2007
Methodological issues in design and analysis of a matched case–control study of a vaccine's effectiveness
Niccolai LM, Ogden LG, Muehlenbein CE, Dziura JD, Vázquez M, Shapiro ED. Methodological issues in design and analysis of a matched case–control study of a vaccine's effectiveness. Journal Of Clinical Epidemiology 2007, 60: 1127-1131. PMID: 17938054, PMCID: PMC2096633, DOI: 10.1016/j.jclinepi.2007.02.009.Peer-Reviewed Original ResearchConceptsCase-control studyTime of vaccinationConditional logistic regression modelsPrelicensure clinical trialsLogistic regression modelsVaricella vaccineVaccine effectivenessVaccine efficacyClinical trialsVaccinationVaccineStudy designRegression modelsEfficacyAgeEffect of timeMethodological issuesTrials
2006
AProspective Open Trial of Guanfacine in Children with Pervasive Developmental Disorders
Scahill L, Aman MG, McDougle CJ, McCracken JT, Tierney E, Dziura J, Arnold LE, Posey D, Young C, Shah B, Ghuman J, Ritz L, Vitiello B. AProspective Open Trial of Guanfacine in Children with Pervasive Developmental Disorders. Journal Of Child And Adolescent Psychopharmacology 2006, 16: 589-598. PMID: 17069547, DOI: 10.1089/cap.2006.16.589.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdrenergic alpha-AgonistsAttention Deficit Disorder with HyperactivityCentral Nervous System StimulantsChildChild Development Disorders, PervasiveChild, PreschoolFemaleGuanfacineHumansMaleMethylphenidatePersonality AssessmentPilot ProjectsProspective StudiesTreatment FailureTreatment OutcomeConceptsOpen-label trialAberrant Behavior ChecklistPervasive developmental disorderClinical Global Impression-ImprovementHyperactivity subscaleEfficacy of guanfacinePlacebo-controlled trialCommon adverse effectsWeeks of treatmentTreatment of hyperactivityDevelopmental disordersBlood pressureOpen trialMean ageSleep disturbancesCommon complaintClinical practiceGuanfacineHyperactivityPilot studyAdverse effectsTrialsBehavior ChecklistChildrenMethylphenidateWait-and-See Prescription for the Treatment of Acute Otitis Media: A Randomized Controlled Trial
Spiro DM, Tay KY, Arnold DH, Dziura JD, Baker MD, Shapiro ED. Wait-and-See Prescription for the Treatment of Acute Otitis Media: A Randomized Controlled Trial. JAMA 2006, 296: 1235-1241. PMID: 16968847, DOI: 10.1001/jama.296.10.1235.Peer-Reviewed Original ResearchConceptsAcute otitis mediaEmergency departmentAntibiotic prescriptionsOtitis mediaTreatment of AOMSevere acute otitis mediaUse of antibioticsClinical courseCommon diagnosisControlled TrialsClinical symptomsAdverse outcomesSubsequent feverAntibiotic useInterview 4Medical careUnnecessary useSP groupRoutine usePatientsPrevious trialsTrialsGroup assignmentAntibioticsOtalgiaYellow Nail Syndrome in Three Siblings: A Randomized Double‐Blind Trial of Topical Vitamin E
Lambert EM, Dziura J, Kauls L, Mercurio M, Antaya RJ. Yellow Nail Syndrome in Three Siblings: A Randomized Double‐Blind Trial of Topical Vitamin E. Pediatric Dermatology 2006, 23: 390-395. PMID: 16918641, DOI: 10.1111/j.1525-1470.2006.00251.x.Peer-Reviewed Original ResearchConceptsYellow nail syndromeTopical vitamin EDouble-blind trialNail syndromeVitamin EPrimary end pointGlobal assessment scoreVitamin E solutionPlacebo treatmentYellow nailsUncommon disorderPeriungual skinRespiratory diseaseDystrophic nailsBlind trialSyndromeEnd pointNail plateAssessment scoresFingernail growthNailTrialsPatientsFirst trialTreatment