Relationship between updated MELD and prognosis in alcohol-associated hepatitis : Opportunities for more efficient trial design
Al-Karaghouli, Mustafa (University of Alberta)
Ventura-Cots, Meritxell (Vall d'Hebron Institut de Recerca (VHIR))
Wong, Yu Jun (University of Alberta)
Genescà Ferrer, Joan (Vall d'Hebron Institut de Recerca (VHIR))
Bosques, Francisco (Universidad Autonoma de Nuevo Leon Monterrey (Mèxic))
Brown, Robert S. (Weill Cornell Medical College (New York, Estats Units d'Amèrica))
Mathurin, Philippe (University of Lille)
Louvet, Alexandre (University of Lille)
Shawcross, Debbie (King's College (London, Regne Unit))
Vargas Blasco, Víctor (Vall d'Hebron Institut de Recerca (VHIR))
Verna, Elizabeth C. (Columbia University Medical Center (New York, Estats Units d'Amèrica))
Schnabl, Bernd (University of California San Diego (La Jolla, Estats Units d'Amèrica))
Caballeria, Joan (Instituto de Salud Carlos III)
Shah, Vijay J. (Mayo Clinic (Rochester, Estats Units d'Amèrica))
Kamath, Patrick S. (Mayo Clinic (Rochester, Estats Units d'Amèrica))
Lucey, Michael R. (University of Wisconsin)
Garcia-Tsao, Guadalupe (University of Pittsburgh Medical Center)
Bataller, Ramon (Hospital Clínic i Provincial de Barcelona)
Abraldes, Juan G. (University of Alberta)
Universitat Autònoma de Barcelona

Data:	2024
Resum:	Alcohol-associated hepatitis (AH) is associated with significant mortality. Model for End-Stage Liver Disease (MELD) score is used to predict short-term mortality and aid in treatment decisions. MELD is frequently updated in the course of AH. However, once the most updated MELD is known, it is uncertain if previous ones still have prognostic value, which might be relevant for transplant allocation and trial design. We aimed to investigate the predictive performance of updated MELDs in a prospectively collected cohort of patients with AH by the InTeam consortium. Three hundred seven patients (with 859 MELD values within 60 d of admission) fulfilled the inclusion criteria. The main endpoint was time to death or transplant up to 90 days. We used a joint model approach to assess the predictive value of updated MELDs. Updated MELD measurements had a strong prognostic value for death/transplant (HR: 1. 20, 95% CI: 1. 14-1. 27) (p < 0. 0001). Previous MELD values did not add predictive value to the most current MELD. We also showed that MELD at day 28 (MELD28) had a significant predictive value for subsequent mortality/transplant in a landmark analysis (HR: 1. 18, 95% CI: 1. 12-1. 23). We show that the use of an ordinal scale including death, transplant, and MELD28 as a trial outcome could substantially reduce the sample size required to demonstrate short-term benefit of an intervention. We show that updated MELDs during the trajectory of AH predict subsequent mortality or the need for transplant. MELD28 inclusion in an ordinal outcome (together with death or transplant) could increase the efficiency of randomized controlled trials.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Publicat a:	Hepatology Communications, Vol. 8 (july 2024) , ISSN 2471-254X

DOI: 10.1097/HC9.0000000000000495
PMID: 39082963

10 p, 532.6 KB

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