Health-related quality of life burden of nonalcoholic steatohepatitis: a robust pragmatic literature review

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 Abstracts of Reviews of Effects (DARE), and Health Technology Assessment Database (HTA). Abstracts 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.

Health-related quality of life and patient-reported outcome measures in NASH-related cirrhosis

“…Although it could be argued that the differentiation and identification of symptoms between different comorbidities, i.e. liver disease and diabetes could be problematic 72 ; cirrhotic patients were reported as having worse physical health/functioning, 27 emotional health, mental health, 50 and were reported to experience more pain than non-cirrhotic patients with NAFLD. 39 Indeed, in 1 study aiming to determine the factors related to disability in cirrhotic outpatients, pain-related disability was reported to be 'nearly universal'.…”

The burden of non-alcoholic steatohepatitis (NASH) among patients from Europe: A real-world patient-reported outcomes study

“…8,27,28 Previous research on the humanistic burden of NASH suggests that the physical burden of NASH, as opposed to the mental/emotional burden of NASH, is most prominent, with fatigue being a major aspect of reduced HRQoL. 9 Chawla et al 28 found that patients with NASH in the US, who were referred for evaluation of histology-proven NASH, exhibited reduced PCS scores, relative to pre-existing standardized general population norms. Similarly, Younossi et al 8 found that patients with NASH in the US and Canada, enrolled in a phase II open label study, exhibited reduced PCS scores (but not reduced MCS scores), relative to the standardized general population norms.…”

“…NASH may be associated with increased healthcare resource use (HRU), 7 impairment of work and non-work activities, 8 and diminished health-related quality of life (HRQoL). 9 Yet, further research is needed to comprehensively examine the humanistic and economic burden of NASH.…”

Identification of Patients with Advanced Fibrosis Due to Nonalcoholic Fatty Liver Disease: Considerations for Best Practice

“…NAFLD/NASH induce non-specific and generally prevalent symptoms [36,37]; a large proportion of cases may be asymptomatic until patients develop decompensated cirrhosis [38][39][40]. Screening is therefore essential to ensure that patients, particularly those with advanced fibrosis (F3-F4), are identified and linked to care.…”