Abstract

To evaluate the differences in HRQoL among patients with NASH compared to type 2 diabetes (T2D) and general controls. Data come from the 2016 EU5 NHWS, a nationally representative patient-reported outcomes survey. Three cohorts were defined: respondents with physician-diagnosed NASH, T2D, and general controls (representative of general population, including T2D but excluding NASH). Respondents with cirrhosis, or viral hepatitis were excluded. The following outcomes are reported: SF-36v2 (physical [PCS] and mental [MCS] component summary scores [Minimal Clinically Important Difference (MCID) = 3], SF-6D health utility index [MCID = 0.041]), and EQ-5D-5L utility [MCID=0.07] (for all measures, lower scores indicate lower HRQoL) and percentage of patients with physician-diagnosed anxiety, depression, or sleep difficulties (other than insomnia, narcolepsy, or sleep apnea) in the past 12 months. Propensity score matching was used to compare NASH vs. matched T2D (1:2) and matched general controls (1:4). Multivariable analyses further controlled for T2D-related covariates (severity and comorbidities) and adjusted means are reported. NASH patients (N=184) vs. general controls (N=736) reported significantly lower MCS (39.2 vs. 45.2), PCS (42.8 vs. 47.8), SF-6D (0.59 vs. 0.68) and EQ-5D-5L (0.67 vs. 0.78) (all p’s <0.001) and significantly more patients reported anxiety (32.0% vs. 17.5%, p<0.001), depression (31.3% vs. 19.6%, p=0.001) and sleep difficulties (15.0% vs. 9.0%, p=0.025). NASH (N=184) vs. T2D (N=368) reported a significantly lower MCS (39.6 vs. 43.6, p=0.003) and SF-6D (0.60 vs 0.64, p=0.002). No significant differences were reported between NASH and T2D for the other outcomes. NASH patients reported low HRQoL and compared to general controls the differences in scores were statistically significant and clinically meaningful. Similar, and in some instances worse (mental impairment and health utility) burden was reported by NASH when compared to T2D, suggesting the burden of NASH is as high as patients with T2D but may be unrecognized.

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