Protocol for the development of a core outcome set for clinical trials in primary sclerosing cholangitis
Hussain N, Ma C, Hirschfield G, Walmsley M, Hanford P, Vesterhus M, Kowdley K, Bergquist A, Ponsioen C, Levy C, Assis D, Schramm C, Bowlus C, Trauner M, Aiyegbusi O, Jairath V, Trivedi P. Protocol for the development of a core outcome set for clinical trials in primary sclerosing cholangitis. BMJ Open 2024, 14: e080143. PMID: 38926149, PMCID: PMC11216047, DOI: 10.1136/bmjopen-2023-080143.Peer-Reviewed Original ResearchConceptsPrimary sclerosing cholangitisClinical trialsSclerosing cholangitisCore outcome setImmune-mediated liver diseasesPrimary sclerosing cholangitis treatmentOutcome measuresEvaluate novel therapiesSlow disease progressionPatient-reported outcome measuresMedical therapyNovel therapiesLiver fibrosisDisease progressionHistological assessmentLiver diseaseInternational two-round Delphi surveyImaging-based biomarkersIntervention trialsTherapyConsensus meetingHealthcare payersCholangitisSemistructured qualitative interviewsTwo-round Delphi surveyAutoimmune hepatitis: Brighton Collaboration case definition and guidelines for data collection, analysis, and presentation of immunisation safety data
Kochhar S, Assis D, Mack C, Izurieta H, Muratori L, Munoz A, Nordenberg D, Gidudu J, Blau E, Vierling J. Autoimmune hepatitis: Brighton Collaboration case definition and guidelines for data collection, analysis, and presentation of immunisation safety data. Vaccine 2024, 42: 1812-1825. PMID: 38368225, DOI: 10.1016/j.vaccine.2024.01.021.Peer-Reviewed Original ResearchAutoimmune hepatitisCase definitionExclusion of alternative diagnosesBrighton CollaborationLevel of diagnostic certaintyBrighton Collaboration case definitionStandardised case definitionsAdverse eventsMiddle-income countriesAlternative diagnosesClinical trialsBackground incidenceSafety dataProcess expertsStudy of safetyClinical case managementDiagnostic certaintyHealthcare accessControl groupData collectionCOVID-19 vaccineExpert consensusCase managementBiochemical testsSystematic review