Cirrhosis is associated with disabling symptoms and diminished health‐related quality of life (HRQOL). However, for patients with compensated disease, data are limited regarding associations with poor patient‐reported outcomes (PROs). We prospectively enrolled 300 patients with cirrhosis and portal hypertension without a history of hepatic encephalopathy (HE) and reviewed medical and pharmacy records. We characterized determinants of PROs using the 8‐item Short‐Form Health Survey (SF‐8) scale (0‐100) and sleep quality using the Pittsburgh Sleep Quality Index (PSQI; poor sleep >5). Disability and frailty measures were assessed using activities of daily living (ADLs), falls, hand‐grip, and chair‐stands. Cognitive function was measured using weighted‐lures from the Inhibitory Control Test (ICT). The median age of our cohort was 60 (interquartile range [IQR], 52‐66) years, 56.3% were male, and 70% Child class A. All patients had portal hypertension, 76% had varices, and 41% had a history of ascites (predominantly well controlled). The median Model for End‐Stage Liver Disease with Sodium (MELD‐Na) score was 9 (IQR, 7‐13). The overall median SF‐8 was 70 (IQR, 54‐86). Multivariate analysis showed that after adjusting for age, sex, education, and MELD‐Na, performance on chair‐stands (9.28 HRQOL points [95% confidence interval {CI}, 4.76‐13.8] per 10‐stands), ADL dependence (–6.06 [–10.8 to –1.36]), opiate use (–5.01 [–7.84 to –2.19]), benzodiazepine use (–3.50 [–6.58 to –0.42]), and ICT performance (–0.10 [–0.20 to 0.001] per weighted‐lure) were significantly associated with HRQOL. Among patients completing the ICT, poor HRQOL (score <50) was significantly associated with chair‐stands (odds ratio [OR] per 10‐stands, 0.24; 95% CI [0.11‐0.56]) and weighted lures (OR per weighted‐lure, 1.01 [1.00‐1.03]). Poor sleep quality was associated with opiate use (OR, 2.85 [1.11‐7.29]) and lures (OR per‐lure, 1.03 [1.00‐1.05]). Conclusion: Disability, chair‐stand performance, cognitive dysfunction, as well as psychoactive medication use are significantly associated with PROs in patients with clinically stable cirrhosis.

INTRODUCTION: Hepatic encephalopathy (HE) is associated with marked increases in morbidity and mortality for patients with cirrhosis. We aimed to determine the risk of and predictors for HE in contemporary patients. METHODS: We prospectively enrolled 294 subjects with Child A-B (70% Child A) cirrhosis and portal hypertension without previous HE from July 2016 to August 2018. The primary outcome was the development of overt HE (grade >2). We assessed the predictive power of model for end-stage liver disease-sodium (MELD-Na) score, the Inhibitory Control Test, the Sickness Impact Profile score, and the Bilirubin–Albumin–Beta-Blocker–Statin score. We also derived a novel predictive model incorporating MELD-Na score, impact of cirrhosis on daily activity (Likert 1–9), frailty (chair-stands per 30 seconds), and health-related quality of life (Short-Form 8, 0–100). RESULTS: The cohort's median age was 60 years, 56% were men, and the median MELD-Na score was 9. During a follow-up of 548 ± 281 days, 62 (21%) had incident overt HE with 1-year probability of 14% ± 2%, 10% ± 2%, and 25% ± 5% for Child A and B. The best model for predicting the risk of overt HE included MELD-Na, Short-Form 8, impact on activity rating, and chair-stands within 30 seconds. This model—MELDNa-Actvity-Chairstands-Quality of Life Hepatic Encephalopathy Score—offered an area under the receiver operating curve (AUROC) for HE development at 12 months of 0.82 compared with 0.55, 0.61, 0.70, and 0.72 for the Inhibitory Control Test, Sickness Impact Profile, Bilirubin–Albumin–Beta-Blocker–Statin, and MELD-Na, respectively. The AUROC for HE-related hospitalization was 0.92. DISCUSSION: This study provides the incidence of HE in a well-characterized cohort of contemporary patients. Bedside measures such as activity, quality of life, and physical function accurately stratified the patient's risk for overt HE.

H epatic encephalopathy (HE) is a common complication of cirrhosis resulting in relapsing-remitting mental status changes ranging from deficits in executive function to coma. Incident HE is associated with an abrupt increase in mortality 1 and frequent hospitalization. 2 To further the understanding of the burden and impact of HE at the population level, valid algorithms are required to identify patients in administrative data. An International Classification of Diseases (ICD)-9 code is specific for HE (572.2), offering a 0.92 positive predictive value (PPV) and 0.36 negative predictive value (NPV). 3 When applied in an algorithm to patients with ICD-9 codes for cirrhosis (eg, 571.5), Kanwal et al 4 found a PPV and NPV of 0.86 and 0.87. Unfortunately, the switch to ICD-10 in 2015 rendered algorithms validated using ICD-9 invalid. Kaplan et al 5 previously showed that lactulose and rifaximin use correlated with grade of HE for Child classification. Herein, we validate a diagnostic coding algorithm for HE using ICD-10 and medication records.

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Cost-effectiveness analysis depends on generalizable health-state utilities. Unfortunately, the available utilities for cirrhosis are dated, may not reflect contemporary patients, and do not capture the impact of cirrhosis symptoms. We aimed to determine health-state utilities for cirrhosis, using both the standard gamble (SG) and visual analog scale (VAS). We prospectively enrolled 305 patients. Disease severity (Child-Pugh [Child] class, Model for End-Stage Liver Disease with sodium [MELD-Na] scores), symptom burden (sleep quality, cramps, falls, pruritus), and disability (activities of daily living) were assessed. Multivariable models were constructed to determine independent clinical associations with utility values. The mean age was 57 ± 13 years, 54% were men, 30% had nonalcoholic steatohepatitis, 26% had alcohol-related cirrhosis, 49% were Child class A, and the median MELD-Na score was 12 (interquartile range [IQR], 8-18). VAS displayed a normal distribution with a wider range than SG. The Child-specific SG-derived utilities had a median value of 0.85 (IQR, 0.68-0.98) for Child A, 0.78 (IQR, 0.58-0.93) for Child B, and 0.78 (IQR, 0.58-0.93) for Child C. VAS-derived utilities had a median value of 0.70 (IQR, 0.60-0.85) for Child A, 0.61 (IQR, 0.50-0.75) for Child B, and 0.55 (IQR, 0.40-0.70) for Child C. VAS and SG were weakly correlated (Spearman's rank correlation coefficient, 0.12; 95% confidence interval, 0.006-0.23). In multivariable models, disability, muscle cramps, and MELD-Na were significantly associated with SG utilities. More clinical covariates were significantly associated with the VAS utilities, including poor sleep, MELD-Na, disability, falls, cramps, and ascites. Conclusion: We provide health-state utilities for contemporary patients with cirrhosis as well as estimates of the independent impact of specific symptoms on each patient's reported utility. (Hepatology Communications 2020;4:852-858). Abbreviations: ADL, activities of daily living; Child, Child-Pugh; CI, confidence interval; HE, hepatic encephalopathy; HRQOL, health-related quality of life; IQR, interquartile range; MELD-Na, Model for End-Stage Liver Disease with sodium; NAFLD, nonalcoholic fatty liver disease; NASH, nonalcoholic steatohepatitis; rs, Spearman's rank correlation coefficient; SG, standard gamble; VAS, visual analog scale.