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 ResearchMeSH KeywordsCOVID-19Data Interpretation, StatisticalHumansPain ManagementPragmatic Clinical Trials as TopicResearch DesignConceptsPragmatic 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 board
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 ResearchMeSH KeywordsAgedAlzheimer DiseaseCaregiver BurdenCommunity Health ServicesComprehensive Health CareCost-Benefit AnalysisFemaleHumansMaleMulticenter Studies as TopicPragmatic Clinical Trials as TopicQuality ImprovementQuality of LifeConceptsCommunity-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 practitioners
2019
User-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