Elizabeth C Verna1, Charles Connelly2, Lorna M Dove1, Patricia Adem3, Nikolina Babic4, James Corsetti5, James Faix6, Joshua A Hayden7, Mark Lifshitz8, Brie Stotler2, Zhezhen Jin9, Sumit Mohan10,11, Jean C Emond1, Eldad A Hod2, Alexander Kratz2. 1. Center for Liver Disease and Transplantation, Columbia University, Vagelos College of Physicians and Surgeons, New York, NY. 2. Department of Pathology and Cell Biology, Vagelos College of Physicians and Surgeons, Columbia University, NewYork-Presbyterian Hospital, New York, NY. 3. Department of Pathology, New York Medical College School of Medicine, Valhalla, NY. 4. Department of Pathology, Mount Sinai Hospital, New York, NY. 5. Department of Pathology and Laboratory Medicine, University of Rochester Medical Center, Rochester, NY. 6. Department of Pathology, Montefiore Medical Center, Bronx, NY. 7. Department of Pathology and Laboratory Medicine, Weill Cornell Medical College, New York, NY. 8. Department of Pathology, New York University Langone Health, New York, NY. 9. Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, NY. 10. Department of Medicine, Division of Nephrology, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY. 11. Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY.
Abstract
BACKGROUND: Model for End-Stage Liver Disease (MELD) score-based liver transplant allocation was implemented as a fair and objective measure to prioritize patients based upon disease severity. Accuracy and reproducibility of MELD is an essential assumption to ensure fairness in organ access. We hypothesized that variability in laboratory methodology between centers could impact allocation scores for individuals on the transplant waiting list. METHODS: Aliquots of 30 patient serum samples were analyzed for creatinine, bilirubin, and sodium in all transplant centers within United Network for Organ Sharing (UNOS) region 9. Descriptive statistics, intraclass correlation coefficients (ICCs), and linear mixed-effects regression were used to determine the relationship between center, bilirubin, and calculated MELD-sodium (MELD-Na) score. RESULTS: The mean MELD-Na score per sample ranged from 14 to 38. The mean range in MELD-Na per sample was 3 points, but 30% of samples had a range of 4-6 points. Correlation plots and intraclass correlation coefficient analysis confirmed bilirubin interfered with creatinine, with worsening agreement in creatinine at high bilirubin levels. Center and bilirubin were independently associated with creatinine reported in mixed-effects models. Unbiased hierarchical clustering suggested that samples from specific centers have consistently higher creatinine and MELD-Na values. CONCLUSIONS: Despite implementation of creatinine standardization, centers within a single UNOS region report clinically significant differences in MELD-Na on an identical sample, with differences of up to 6 points in high MELD-Na patients. The bias in MELD-Na scores based upon center choice within a region should be addressed in the current efforts to eliminate disparities in liver transplant access.
BACKGROUND: Model for End-Stage Liver Disease (MELD) score-based liver transplant allocation was implemented as a fair and objective measure to prioritize patients based upon disease severity. Accuracy and reproducibility of MELD is an essential assumption to ensure fairness in organ access. We hypothesized that variability in laboratory methodology between centers could impact allocation scores for individuals on the transplant waiting list. METHODS: Aliquots of 30 patient serum samples were analyzed for creatinine, bilirubin, and sodium in all transplant centers within United Network for Organ Sharing (UNOS) region 9. Descriptive statistics, intraclass correlation coefficients (ICCs), and linear mixed-effects regression were used to determine the relationship between center, bilirubin, and calculated MELD-sodium (MELD-Na) score. RESULTS: The mean MELD-Na score per sample ranged from 14 to 38. The mean range in MELD-Na per sample was 3 points, but 30% of samples had a range of 4-6 points. Correlation plots and intraclass correlation coefficient analysis confirmed bilirubin interfered with creatinine, with worsening agreement in creatinine at high bilirubin levels. Center and bilirubin were independently associated with creatinine reported in mixed-effects models. Unbiased hierarchical clustering suggested that samples from specific centers have consistently higher creatinine and MELD-Na values. CONCLUSIONS: Despite implementation of creatinine standardization, centers within a single UNOS region report clinically significant differences in MELD-Na on an identical sample, with differences of up to 6 points in high MELD-Na patients. The bias in MELD-Na scores based upon center choice within a region should be addressed in the current efforts to eliminate disparities in liver transplant access.
Authors: Jacques Pirenne; Bart van Hoek; Andries E Braat; Ben F J Goudsmit; Hein Putter; Maarten E Tushuizen; Serge Vogelaar; Ian P J Alwayn Journal: Hepatology Date: 2021-05-09 Impact factor: 17.425