2024
Relationship between updated MELD and prognosis in alcohol-associated hepatitis: Opportunities for more efficient trial design
Al-Karaghouli M, Ventura-Cots M, Wong Y, Genesca J, Bosques F, Brown R, Mathurin P, Louvet A, Shawcross D, Vargas V, Verna E, Schnabl B, Caballeria J, Shah V, Kamath P, Lucey M, Garcia-Tsao G, Bataller R, Abraldes J. Relationship between updated MELD and prognosis in alcohol-associated hepatitis: Opportunities for more efficient trial design. Hepatology Communications 2024, 8: e0495. PMID: 39082963, DOI: 10.1097/hc9.0000000000000495.Peer-Reviewed Original ResearchConceptsAlcohol-associated hepatitisTrial designRandomized controlled trialsShort-term mortalityInclusion criteriaPredictive valuePrognostic valueControlled trialsShort-term benefitsEfficient trial designTrial outcomesAssociated with significant mortalityCourse of AHCohort of patientsTreatment decisionsSample sizeOrdinal outcomesMortalityOrdinal scaleMELD valuesLandmark analysisTransplant allocationTrialsOutcomesTransplantation
2020
Ordinal Outcomes Are Superior to Binary Outcomes for Designing and Evaluating Clinical Trials in Compensated Cirrhosis
D’Amico G, Abraldes JG, Rebora P, Valsecchi MG, Garcia‐Tsao G. Ordinal Outcomes Are Superior to Binary Outcomes for Designing and Evaluating Clinical Trials in Compensated Cirrhosis. Hepatology 2020, 72: 1029-1042. PMID: 31837238, PMCID: PMC11090179, DOI: 10.1002/hep.31070.Peer-Reviewed Original ResearchConceptsClinical trialsGrade 1Prevention of decompensationBaseline platelet countDevelopment of varicesSignificant outcome differencesLow baseline riskPrimary therapeutic targetCirrhosis decompensationCompensated cirrhosisInception cohortComposite endpointEsophageal varicesPlatelet countBinary outcomesDisease progressionSignificant treatment effectBaseline riskGrade 3Sample sizeOutcome differencesTherapeutic targetDecompensationGrade 2Larger sample size