Division of Gastroenterology (Liver Unit). University of Alberta, Edmonton, Alberta, Canada.
Liver Unit, Hospital Universitari Vall d'Hebron, Vall d'Hebron Research Institute (VHIR), Vall d'Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Barcelona, Spain.
Hepatol Commun. 2024 Jul 31;8(8). doi: 10.1097/HC9.0000000000000495. eCollection 2024 Aug 1.
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.
酒精相关性肝炎（AH）与较高的死亡率相关。终末期肝病模型（MELD）评分用于预测短期死亡率并辅助治疗决策。在 AH 病程中，MELD 评分会频繁更新。然而，一旦获得最新的 MELD 评分，之前的评分是否仍具有预后价值尚不清楚，这可能与肝移植的分配和临床试验的设计相关。我们旨在通过 InTeam 联盟的前瞻性收集的 AH 患者队列，研究更新的 MELD 在预测中的表现。
307 名（在入院后 60 天内有 859 个 MELD 值）符合纳入标准的患者纳入研究。主要终点是 90 天内死亡或移植的时间。我们使用联合模型方法来评估更新的 MELD 的预测价值。
更新的 MELD 测量值对死亡/移植具有很强的预后价值（HR：1.20，95%CI：1.14-1.27）（p<0.0001）。之前的 MELD 值对最新的 MELD 值没有增加预测价值。我们还表明，在 landmark 分析中，MELD 在第 28 天（MELD28）的测量值对随后的死亡率/移植具有显著的预测价值（HR：1.18，95%CI：1.12-1.23）。我们表明，使用包含死亡、移植和 MELD28 的有序尺度作为临床试验结果，可以大大减少证明干预措施短期获益所需的样本量。
我们表明，AH 病程中更新的 MELD 预测随后的死亡率或移植需求。将 MELD28 纳入有序结局（与死亡或移植一起）可以提高随机对照试验的效率。
