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The present study was supported by the Spanish Ministry of Research and Innovation, the "Instituto de Salud Carlos III" (grant reference PI22/00312), the "Agencia Estatal de Investigacion (Espana)" (grant reference: PID2020-115454GB-C22/AEI/10.13039/501100011033) , and co-funded by the European Union. AMG-O was supported by "Consejeria de Trans-formacion Economica, Industria, Conocimiento y Universidades de la Junta de Andalucia" (grant reference: PREDOC-00489) . DG-R was supported by the "Agencia Estatal de Investigacion (Espana)" and European Union NextGenerationEU/PRTR (grant ref.: JDC2022-048378-I).We would like to acknowledge the labour of Dr. Rafael Garrido Garcia and Ms. Eva Bech who kindly provided advice for the study design on behalf of the "Fundacion Nacional de pacientes Trasplantados Hepaticos (FNETH)", which is the national association of people living with a liver transplant in Spain. We also thank the Spanish hepatologist women group (GEMHep) for their continuous support, with some of its members actively involved in the project from its inception.

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GEMA-Na and MELD 3.0 severity scores to address sex disparities for accessing liver transplantation: a nationwide retrospective cohort study

Publicated to:Eclinicalmedicine. 74 102737- - 2024-08-01 74(), DOI: 10.1016/j.eclinm.2024.102737

Authors: Rodríguez-Perálvarez, ML; Aguilera, MV; Pagano, G; Mateos, RM; Pascual, S; Romero, M; Bilbao, I; García, AR; Cano, CS; Colmenero, J; Moreno, SR; Soler, MR; de la Rosa, G; Gómez-Orellana, AM; Guijo-Rubio, D; Martínez, CH; Vicente, TP; Gastaca, M; Pereira, S; Cepeda-Franco, C; Ortiz, ML; Pons, JA; Suarez, F; Otero, A; Grande, RG; Cachero, A; Navarrete, AA; Tomé, S; Barreales, M; Martín, CA; Otón, E; Diéguez, LG; Espinosa, MD; Milla, AA; Fernández, GB; Lorente, S; Lavín, AC

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Abstract

Background The Gender-Equity Model for liver Allocation corrected by serum sodium (GEMA-Na) and the Model for End-stage Liver Disease 3.0 (MELD 3.0) could amend sex disparities for accessing liver transplantation (LT). We aimed to assess these inequities in Spain and to compare the performance of GEMA-Na and MELD 3.0. Methods Nationwide cohort study including adult patients listed for a first elective LT (January 2016-December 2021). The primary outcome was mortality or delisting for sickness within the first 90 days. Independent predictors of the primary outcome were evaluated using multivariate Cox's regression with adjusted relative risks (RR) and 95% confidence intervals (95% CI). The discrimination of GEMA-Na and MELD 3.0was assessed using Harrell c-statistics (Hc). Findings The study included 6071 patients (4697 men and 1374 women). Mortality or delisting for clinical deterioration occurred in 286 patients at 90 days (4.7%). Women had reduced access to LT (83.7% vs. 85.9%; p = 0.037) and increased risk of mortality or delisting for sickness at 90 days (adjusted RR = 1.57 [95% CI 1.09-2.28]; p = 0.017). Female sex remained as an independent risk factor when using MELD or MELD-Na but lost its significance in the presence of GEMA-Na or MELD 3.0. Among patients included for reasons other than tumours (n = 3606; 59.4%), GEMA-Na had Hc = 0.753 (95% CI 0.715-0.792), which was higher than MELD 3.0 (Hc = 0.726 [95% CI 0.686-0.767; p = 0.001), showing both models adequate calibration. Interpretation GEMA-Na and MELD 3.0 might correct sex disparities for accessing LT, but GEMA-Na provides more accurate predictions of waiting list outcomes and could be considered the standard of care for waiting list prioritization. Funding Instituto de Salud Carlos III, Agencia Estatal de Investigaci & oacute;n (Spain), and European Union. Copyright (c) 2024 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

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