Global Pharmacoepidemiology, Human Data Sciences, Cardiff, UK.
Market Access and Government Affairs, Norgine Pharmaceuticals Limited, Uxbridge, UK.
Hepatol Commun. 2023 Nov 6;7(11). doi: 10.1097/HC9.0000000000000307. eCollection 2023 Nov 1.
HE is a common neurologic complication in cirrhosis associated with substantial disease and economic burden. HE symptoms are nonspecific and there are limited ways of identifying patients with cirrhosis at high risk of later developing HE. A risk score was previously developed to identify patients at risk of developing HE in a predominately male US cohort. Here, we evaluated the performance of the HE risk scores in a UK cohort study.
Health care records from Clinical Practice Research Datalink and linked Hospital Episode Statistics were used to select patients with cirrhosis who were diagnosed with HE, confirmed by a diagnosis code for HE or a rifaximin-α prescription. The index date was the date of incident cirrhosis. The study period was from January 2003 to June 2019.
A total of 40,809 patients with cirrhosis were selected in the UK cohort, of whom 59% were male. A total of 1561 patients were diagnosed with HE. Applying the UK cohort to the baseline sensitivity risk cutoff (≥-11) from the US cohort provided a sensitivity of 92% and a negative predictive value of 99%. Within a longitudinal model, applying a sensitivity cutoff of ≥-3 to this cohort gave a sensitivity of 89% and a negative predictive value of 99%.
Using data from the UK, the previously developed HE risk scores were found to be reliable for selecting those most likely to progress to HE in patients with liver cirrhosis. Despite the HE risk scores originally being estimated using the data from a predominately male US cohort, the scores were validated and found to be generalizable to female patients.
HE 是肝硬化的一种常见神经系统并发症,与大量疾病和经济负担有关。HE 的症状不具有特异性,并且只有有限的方法可以识别肝硬化患者中具有较高风险的患者会发展为 HE。之前已经开发了一种风险评分来识别主要为男性的美国队列中发生 HE 的风险患者。在这里,我们评估了该 HE 风险评分在英国队列研究中的表现。
使用临床实践研究数据库和相关的医院发病统计数据中的医疗记录,选择被诊断为肝硬化且 HE 确诊(通过 HE 的诊断代码或利福昔明-α处方)的患者。索引日期为肝硬化的发病日期。研究期间为 2003 年 1 月至 2019 年 6 月。
在英国队列中选择了 40809 名肝硬化患者,其中 59%为男性。共有 1561 名患者被诊断为 HE。将英国队列应用于美国队列中的基线灵敏度风险截止值(≥-11),其灵敏度为 92%,阴性预测值为 99%。在纵向模型中,对该队列应用灵敏度截止值≥-3,灵敏度为 89%,阴性预测值为 99%。
使用来自英国的数据,发现先前开发的 HE 风险评分可用于选择肝硬化患者中最有可能进展为 HE 的患者。尽管 HE 风险评分最初是使用主要为男性的美国队列数据估算的,但评分得到了验证,并且发现可以推广到女性患者。