- 1Center for Liver Diseases and Department of Medicine, Inova Fairfax Hospital, Falls Church, VA, USA.
- 2Inova Medicine, Inova Health System, Falls Church VA, USA.
- 3DRG Abacus (Clarivate), Gurgaon, Haryana, India.
- 4Novo Nordisk A/S, Søborg, Denmark.
- 5Novo Nordisk Denmark A/S, Region North & West Europe, Ørestad, Denmark.
- 6Novo Nordisk Ltd, Gatwick, UK.
- 7DRG Abacus (Clarivate), Mumbai, Maharashtra, India.
Background & aims: Non-alcoholic steatohepatitis (NASH) is associated with increased mortality and a high clinical burden. NASH adversely impacts patients' health-related quality of life (HRQoL), but published data on the humanistic burden of disease are limited. This review aimed to summarise and critically evaluate studies reporting HRQoL or patient-reported outcomes (PROs) in populations with NASH and identify key gaps for further research.
Methods: Medline, EMBASE, the Cochrane Library and PsycINFO were searched for English-language publications published from 2010 to 2021 that reported HRQoL/PRO outcomes of a population or subpopulation with NASH.
Results: Twenty-five publications covering 23 unique studies were identified. Overall, the data showed a substantial impact of NASH on HRQoL, particularly in terms of physical functioning and fatigue, with deterioration of physical and mental health as NASH progresses. Prevalent symptoms, including fatigue, abdominal pain, anxiety/depression, cognition problems, and poor sleep quality, adversely impact patients' ability to work and perform activities of daily living and the quality of relationships. However, some patients fail to attribute symptoms to their disease because of a lack of patient awareness and education. NASH is associated with high rates of comorbidities such as obesity and type 2 diabetes, which contribute to reduced HRQoL. Studies were heterogeneous in terms of diagnostic methods, population, outcomes, follow-up time, and measures of HRQoL/utility. Most studies were rated 'moderate' at quality assessment, and all evaluable studies had inadequate control of confounders.
Conclusions: NASH is associated with a significant HRQoL burden that begins early in the disease course and increases with disease progression. More robust studies are needed to better understand the humanistic burden of NASH, with adequate adjustment for confounders that could influence outcomes.
Lay summary: Non-alcoholic steatohepatitis (NASH) has a significant impact on quality of life, with individuals experiencing worse physical and mental health compared with the general population. NASH and its symptoms, which include tiredness, stomach pain, anxiety, depression, poor focus and memory, and impaired sleep, affect individuals' relationships and ability to work and perform day-to-day tasks. However, not all patients are aware that their symptoms may be related to NASH. Patients would benefit from more education on their disease, and the importance of good social networks for patient health and well-being should be reinforced. More studies are needed to better understand the patient burden of NASH.
Keywords: AIS, Athens Insomnia Scale; BC, biopsy-confirmed; BDI-II, Beck Depression Inventory-II; Burden of disease; CC, compensated cirrhosis; CD, cognitive debriefing; CE, concept elicitation; CHC, chronic hepatitis C; CLD, chronic liver disease; CLDQ, Chronic Liver Disease Questionnaire; CVD, cardiovascular disease; Comorbidities; Disease progression; ELF, enhanced liver fibrosis; EPHPP, Effective Public Health Practice Project; EQ-5D, EuroQol-5D; EQ-5D-5L, EuroQol-5D-5 level; F1–4, fibrosis stages 1–4; FSSG, frequency scale for the symptoms of gastro-oesophageal reflux disease; GERD, gastro-oesophageal reflux disease; GGT, gamma-glutamyl transpeptidase; GI, gastrointestinal; GfK, Growth from Knowledge; HADS, Hospital Anxiety and Depression Scale; HCC, hepatocellular carcinoma; HRQoL, health-related quality of life; Health-related quality of life; MCID, minimal clinically important difference; MCS, mental component summary; N/A, not available; NAFL, non-alcoholic fatty liver; NAFLD, non-alcoholic fatty liver disease; NAS, NAFLD activity score; NASH; NASH, non-alcoholic steatohepatitis; NFS, non-alcoholic fatty liver disease fibrosis score; NICE, National Institute for Health and Care Excellence; NIT, non-invasive test; NR, not reported; Non-alcoholic steatohepatitis; OR, odds ratio; PCS, physical component summary; PHAQ, Patient-Reported Outcome Measurement Information System Health Assessment Questionnaire; PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses; PRO, patient-reported outcome; Patient-reported outcomes; QD, once daily; QoL, quality of life; RCT, randomised controlled trial; SF-12, 12-item Short Form Health Survey; SF-36, Short Form-36; SF-6D, Short Form–6 Dimension; SG, standard gamble; SPAN, School Physical Activity and Nutrition; Symptoms; T2D, type 2 diabetes; VAS, visual analogue scale; WPAI, Work Productivity and Activity Impairment; WPAI:SHP, Work Productivity and Activity Impairment: Specific Health Problem; e1, excluded after screening title and abstract; e2, excluded after screening full text; i1, included to screen based on title and abstract; i2, included to screen full text; i3, total included studies after the full-text review stage for original report and 2021 search update.