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Journal of Patient-Reported Outcomes
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Table 1 NASH study objectives, methods, setting, and HRQoL tools/methods in the included studies

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

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)
  1. 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
  2. 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
  3. bThere are no licensed therapies for NASH
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