2022
Pragmatic clinical trial design in emergency medicine: Study considerations and design types
Gettel CJ, Yiadom MYAB, Bernstein SL, Grudzen CR, Nath B, Li F, Hwang U, Hess EP, Melnick ER. Pragmatic clinical trial design in emergency medicine: Study considerations and design types. Academic Emergency Medicine 2022, 29: 1247-1257. PMID: 35475533, PMCID: PMC9790188, DOI: 10.1111/acem.14513.Peer-Reviewed Original ResearchConceptsPragmatic clinical trialsClinical trial designTrial designReal-world clinical practicePragmatic clinical trial designElectronic health recordsEmergency departmentClinical trialsStudy design typeClinical practiceStudy typeTrial componentsHealth recordsEmergency medicineEmergency medicine investigatorsHuman subjects concernsInvestigatorsStudy findingsStudy considerationsTrialistsTrials
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