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
Clinical Research in Hepatology in the COVID‐19 Pandemic and Post‐Pandemic Era: Challenges and the Need for Innovation
Verna EC, Serper M, Chu J, Corey K, Fix OK, Hoyt K, Page KA, Loomba R, Li M, Everson GT, Fried MW, Garcia‐Tsao G, Terrault N, Lok AS, Chung RT, Reddy KR. Clinical Research in Hepatology in the COVID‐19 Pandemic and Post‐Pandemic Era: Challenges and the Need for Innovation. Hepatology 2020, 72: 1819-1837. PMID: 32740969, PMCID: PMC7435542, DOI: 10.1002/hep.31491.Peer-Reviewed Original ResearchConceptsClinical researchInvestigational productAcute respiratory syndrome coronavirus 2 pandemicSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemicChronic liver diseaseLong-term followCoronavirus 2 pandemicClinical trial designImplementation of telemedicineHepatitis BLiver diseaseLaboratory monitoringClinical careTrial designCoronavirus disease 2019 (COVID-19) researchNatural historyCompletion of studyTherapeutic developmentNational InstituteCOVID-19 pandemicHepatologyOngoing studiesDiseaseIndustry fundingPandemic
2016
Consensus Statements: Preventing Recurrent Variceal Hemorrhage and Other Decompensating Events
Abraldes J, Albillos A, Augustin S, Moreau R, Reiberger T, Ripoll C, Salerno F, Garcia-Tsao G. Consensus Statements: Preventing Recurrent Variceal Hemorrhage and Other Decompensating Events. 2016, 365-367. DOI: 10.1007/978-3-319-23018-4_36.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsIssues in Trial Design and Areas Needing Further Research
Abraldes J, Salerno F, Augustin S, Ripoll C, Reiberger T, Moreau R, Albillos A, Garcia-Tsao G. Issues in Trial Design and Areas Needing Further Research. 2016, 355-363. DOI: 10.1007/978-3-319-23018-4_35.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsPrimary end pointVariceal bleedingEnd pointTrial designAppropriate primary end pointVariceal bleeding episodesComplications of cirrhosisNew therapeutic approachesBleeding episodesMultiple complicationsTherapeutic trialsCase mortalityTherapeutic approachesHigh riskLower riskPatientsClinical scenariosComplicationsBleedingPrevious trialsCirrhosisSecond complicationMortalityTrialsDeath