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 surveyAssessment of fatigue and its impact in chronic liver disease
Younossi Z, Kremer A, Swain M, Jones D, Bowlus C, Trauner M, Henry L, Gerber L. Assessment of fatigue and its impact in chronic liver disease. Journal Of Hepatology 2024, 81: 726-742. PMID: 38670320, DOI: 10.1016/j.jhep.2024.04.008.Peer-Reviewed Original ResearchLevels of fatigueHealth related qualityBurden of chronic liver diseaseRelated qualityHepatitis C viral infectionPatients' health related qualityImpact of fatiguePrimary biliary cholangitisAssessment of fatigueChronic liver diseaseExpert reviewComplexity of fatigueSelf-report instrumentImproved HRQLPRO dataSelf-report measuresHRQLLiver diseaseOutcome measuresPeripheral causesChronic hepatitis C viral infectionChronic liver disease severityComprehensive burdenStage of chronic liver diseasePresence of cirrhosis