2024
Design and implementation of community consultation for research conducted under exception from informed consent regulations for the PreVent and the PreVent 2 trials: Changes over time and during the COVID-19 pandemic
Gugel T, Adams K, Baranoski M, Yanez N, Kampp M, Johnson T, Aydin A, Fajardo E, Sharp E, Potnis A, Johnson C, Treggiari M. Design and implementation of community consultation for research conducted under exception from informed consent regulations for the PreVent and the PreVent 2 trials: Changes over time and during the COVID-19 pandemic. Clinical Trials 2024, 21: 671-680. PMID: 38676438, PMCID: PMC11512686, DOI: 10.1177/17407745241243045.Peer-Reviewed Original ResearchPublic disclosure activitiesCommunity consultationInstitutional review boardConsent regulationsIn-personEmergency researchRegulatory measuresCOVID-19 pandemicPublic disclosureSponsor-investigatorsPublic supportPrevention experimentsCommunity leadersIn-person eventsYear of implementationFood and Drug AdministrationHigher education levelCommunity concernsReview boardSelection biasProportion of respondentsMethod of contactClinical researchLocal communitiesCOVID-19
2023
Association of Early Dexmedetomidine Utilization With Clinical and Functional Outcomes Following Moderate-Severe Traumatic Brain Injury: A Transforming Clinical Research and Knowledge in Traumatic Brain Injury Study*
Liu S, Kelly-Hedrick M, Temkin N, Barber J, Komisarow J, Hatfield J, Ohnuma T, Manley G, Treggiari M, Colton K, Vavilala M, Grandhi R, Laskowitz D, Mathew J, Hernandez A, James M, Raghunathan K, Goldstein B, Markowitz A, Krishnamoorthy V, Investigators T. Association of Early Dexmedetomidine Utilization With Clinical and Functional Outcomes Following Moderate-Severe Traumatic Brain Injury: A Transforming Clinical Research and Knowledge in Traumatic Brain Injury Study*. Critical Care Medicine 2023, 52: 607-617. PMID: 37966330, PMCID: PMC10939970, DOI: 10.1097/ccm.0000000000006106.Peer-Reviewed Original ResearchModerate-severe traumatic brain injuryDisability Rating ScaleDexmedetomidine exposureHours of admissionTraumatic brain injuryFunctional outcomeHospital stayMechanical ventilationBrain injuryICP monitoringGlasgow Outcome Scale-ExtendedLevel 1 trauma centerClinical researchSevere traumatic brain injuryTraumatic Brain Injury (CENTER-TBI) studyFollowing secondary outcomesRetrospective cohort studySecond-line agentsPropensity-weighted modelsBrain Injury StudyLower DRS scoresEarly dexmedetomidineHospital mortalitySedation choiceUnexposed patients