Abstract
ObjectiveNonalcoholic steatohepatitis (NASH) is a form of chronic liver disease (CLD): patients have an increased risk of developing cirrhosis, liver failure, and complications (e.g. hepatocellular carcinoma). NASH has a high clinical burden, and likely impairs patients’ health-related quality of life (HRQoL), but there are currently no licensed therapies. The objective of this robust pragmatic literature review was to identify and describe recent studies on the HRQoL burden of NASH from the patient perspective.MethodsEnglish-language primary research studies were identified that measured HRQoL in adults with NASH (population-based studies or clinical trials of pharmacological therapy). Searches were conducted in the following bibliographical databases: MEDLINE, EMBASE, Cochrane Database of Systematic Reviews (CDSR), Cochrane Central Register of Controlled Trials (CENTRAL), Database of s of Reviews of Effects (DARE), and Health Technology Assessment Database (HTA). s from selected congresses (2015/2016) were hand searched. Articles were assessed for relevance by two independent reviewers, and HRQoL data were extracted.ResultsA total of 567 de-duplicated abstracts were identified, and 20 full-text articles were reviewed. Eight studies were included: five quantitative, two interventional, and one qualitative. The quantitative and interventional studies measured HRQoL using the Short-Form 36 (SF-36) and the Chronic Liver Disease Questionnaire (CLDQ), and the qualitative study involved focus groups and individual interviews. Overall, the studies showed that NASH affects HRQoL, especially physical functioning, with many patients reporting being fatigued. In quantitative studies, overall, patients with NASH had a reduced HRQoL versus normative populations and nonalcoholic fatty liver disease (NAFLD) patients, but not versus chronic liver diseases. A longitudinal study showed that when weight loss was achieved, HRQoL improvement over 6 months was greater in patients with NASH versus NAFLD. Qualitative research suggested that, in addition to fatigue, other symptoms are also burdensome, having a broad negative impact on patients’ lives. The impact of pharmacological treatment on HRQoL was explored in only two included studies.ConclusionsHRQoL is impaired in patients with NASH. Patients experience a range of symptoms, especially fatigue, and the impact on their lives is broad. Further research is needed to understand the HRQoL burden of NASH (e.g. assessing NASH-specific impacts not captured by SF-36 and CLDQ) and the impact of future NASH therapies on HRQoL.
Highlights
Nonalcoholic steatohepatitis (NASH) is a form of chronic liver disease (CLD) in adults and children
The literature search yielded a total of 567 de-duplicated abstracts, and 20 full-text articles were reviewed for relevance
A total of eight studies were suitable for inclusion in the final literature review (Fig. 1)
Summary
Nonalcoholic steatohepatitis (NASH) is a form of chronic liver disease (CLD) in adults and children. NASH is characterized by hepatic steatosis (fatty infiltration of the liver) and inflammation, with hepatocyte injury (ballooning) with or without fibrosis [1]. In the USA, the estimated prevalence of NASH in the general population ranges from 3% to 5% (reviewed by Vernon et al, 2011 [3]). The reported prevalence of NASH is up to 56% (reviewed by Lopez-Velazquez et al 2014 [4] and in Vernon et al, 2011 [3]). NASH is the second leading indication of CLD for liver transplant (LT) in the USA [6]. In a meta-analysis, the rates of liver-specific and overall mortality in patients with NASH were 11.8 and 25.6 per 1000 person-years, respectively [7]
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