Kensinger Clark D, Feurer Irene D, Karp Seth J
1 Department of Surgery, Vanderbilt Transplant Center, Vanderbilt, University Medical Center, Nashville, TN. 2 Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN.
Transplantation. 2017 Sep;101(9):2056-2061. doi: 10.1097/TP.0000000000001812.
Current Model for End-Stage Liver Disease (MELD) exception points provided to patients with hepatocellular cancer (HCC) are not based on outcome data and advantage these patients compared to those listed based on laboratory values (LABMELD). We sought to develop a data-based assignment for exception points for patients with HCC that equalizes outcomes among HCC and LABMELD patients.
We used Scientific Registry of Transplant Recipients data to compare patients listed with HCC who received exception points versus patients listed with LABMELD. Nation- and region-specific data were examined for (1) a composite outcome for adverse events of death, delisting, or becoming ineligible for transplant; and (2) transplant rate. We also determined MELD progression rates for LABMELD patients. Candidates listed with LABMELD scores were compared with those listed with 22 exception points for HCC (HCC22) to determine the LABMELD for which statistical parity was achieved for our composite outcome.
HCC22 candidates time to adverse event were comparable to LABMELD scores of 16 (LABMELD16) candidates (range, 15-19), whereas time to transplant was comparable to LABMELD22 candidates (range, 21-23). LABMELD22 candidates had 2.1 times greater risk of adverse event compared with HCC22 (95% confidence interval, 1.9-2.4; range, 1.5-2.4). Progression among LABMELD16 candidates whose scores did not improve was similar across regions and averaged 0.94 points/month (95% confidence interval, 0.88-0.99, range 0.80-1.04).
To equalize the occurrence of an adverse outcome, the proper listing MELD for patients with HCC is 16, with approximately 1 additional point/month. These results provide a data-driven algorithm to increase fairness in listing priority.
终末期肝病模型(MELD)给予肝细胞癌(HCC)患者的例外点数并非基于预后数据,与基于实验室值列出的患者(LABMELD)相比,这些患者具有优势。我们试图为HCC患者开发一种基于数据的例外点数分配方法,以使HCC患者和LABMELD患者的预后相等。
我们使用移植受者科学登记处的数据,比较获得例外点数的HCC登记患者与LABMELD登记患者。针对(1)死亡、退出名单或失去移植资格等不良事件的综合结局;以及(2)移植率,检查了国家和地区特定数据。我们还确定了LABMELD患者的MELD进展率。将列出LABMELD分数的候选者与列出HCC 22个例外点数(HCC22)的候选者进行比较,以确定在我们的综合结局方面实现统计均等的LABMELD分数。
HCC22候选者发生不良事件的时间与LABMELD分数为16(LABMELD16)的候选者相当(范围为15 - 19),而移植时间与LABMELD22候选者相当(范围为21 - 23)。与HCC22相比,LABMELD22候选者发生不良事件的风险高2.1倍(95%置信区间,1.9 - 2.4;范围,1.5 - 2.4)。LABMELD16分数未改善的候选者在各地区的进展相似,平均每月增加0.94分(95%置信区间,0.88 - 0.99,范围0.80 - 1.04)。
为使不良结局的发生率相等,HCC患者合适的登记MELD分数为16,每月大约增加1分。这些结果提供了一种数据驱动的算法,以提高登记优先级的公平性。