Table 1.
NASH study objectives, methods, setting, and HRQoL tools/methods in the included studies
| Reference | Objective | Study design | Countries | Tools or method of capturing HRQoL | Qualitative analysis software |
|---|---|---|---|---|---|
| Quantitative studies reporting HRQoL in patients with NASH | |||||
| Alt et al., 2016 [11] | Evaluate HRQoL in patients with CLD and in CLD patients divided by etiology, including NASH | Retrospective, cross-sectional, single-center study | Germany | CLDQ (German version) | IBM SPSS Statistic V.21.0 (IBM Corp., Armonk, NY) |
| Chawla et al., 2016 [12] | Assess HRQoL in patients with NASH and compare NASH vs normative US dataa | Prospective, cross-sectional, single clinic study | USA | SF-36, CLDQ | SAS V.8.2 (SAS Institute Inc., Cary, NC, USA) |
| David et al., 2009 [8] | Compare HRQoL in patients with NAFLD (with and without NASH) vs normative US population | Retrospective, cross-sectional, eight-center study (database and RCT data) | USA | SF-36 | NR |
| Sayiner et al., 2016 [13] | Compare HRQoL in patients with cirrhotic NAFLD vs those with noncirrhotic NAFLD and also vs the general population | Prospective, cross-sectional, single clinic study | USA | SF-36 (and SF-6D health utility scores derived) | SAS (SAS Institute Inc., Cary, NC, USA) |
| Tapper and Lai, 2016 [14] | Assess HRQoL changes from baseline to 6 months in NAFLD and NASH patients with and without significant weight loss | Prospective, longitudinal (6-month) registry study | USA | CLDQ | JMP Pro statistical discovery (V.11; SAS Institute Inc., Cary, NC, USA) |
| Interventional trials reporting HRQoL impact of pharmacological therapies for NASHb | |||||
| Chande et al., 2006 [15] | Determine the effects of an herbal medicine (YHK) versus placebo for 8 weeks on HRQoL (secondary outcome) in patients with NASH and persistently elevated transaminases | Prospective, longitudinal (8-week), randomized, double-blind, placebo-controlled, single-center, pilot study | Japan | SF-36 | NR |
| Sanyal et al., 2010 [16] | Assess the change in HRQoL (secondary outcome) from baseline to the end of 96 weeks’ treatment with pioglitazone, vitamin E, or placebo in patients with NASH (without DM) | Prospective, longitudinal (96-week), randomized, double-blind, placebo-controlled, multicenter, phase 3 clinical trial | USA | SF-36 | NR |
| Qualitative research in patients with NASH | |||||
| Palsgrove et al., 2016 [17] | Undertake qualitative research to inform the development of a conceptual model as part of the process of developing a NASH-specific PRO | Qualitative study (focus groups and individual interviews) | North America, Europe, South America, Australasia | Qualitative methods | MAXQDA Plus (VERBI GmbH, Berlin, Germany) |
CLD, chronic liver disease; CLDQ, Chronic Liver Disease Questionnaire; HRQoL, health-related quality of life; NAFLD, nonalcoholic fatty liver disease; NASH, nonalcoholic steatohepatitis; NR, not reported; PRO, patient-reported outcome; RCT, randomized controlled trial; SF-36, Short-Form 36; SF-6D, Short-Form Six-Dimension; YHK, Yo Jyo Hen Shi Ko
aThe primary aim of the study by Chawla et al. (2016) was to assess the reliability and validity of the CLDQ (vs the SF-36) in patients with NASH: CLDQ was found to be a reliable and valid disease-specific HRQoL measure in adults with NASH
bThere are no licensed therapies for NASH