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Table 2 Patient populations in the included studies

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

Reference Patient population Patient numbers How NASH was diagnosed/confirmed
Quantitative studies reporting HRQoL in patients with NASH
 Alt et al., 2016 [11] Outpatients with noninfectious CLD of different etiologies (including NASH) who were referred to the outpatient clinic of the University Medical Centre of the Johannes Gutenberg University Mainz (excluded malignant disease, previous LT) CLD n = 150
 NASH n = 29 (19.3%)
 NAFLD n = 25 (16.7%)
NASH n = 29
 Median age 52 y (range 24–76)
 Males 48.3%
 Cirrhosis, n = 10 (34.5%)
CLD etiology (including NASH) determined clinically and by biopsy
Biopsy n = 81 (54%)
 Chawla et al., 2016 [12] Adults referred for the evaluation of histology-proven NASH at Mayo Clinic, Rochester (excluded cirrhosis, biliary obstruction) NASH n = 79
 Mean age 46 y (SE 11)
 Males 35%
Age-and gender-matched US population sample, n = 2474a
 Mean age 46 y
 Males 39%
Normative data for healthy controlsb
(1) Abnormal serum liver tests for > 3 months; (2) liver histology revealing > 10% steatosis and lobular inflammation with or without fibrosis; (3) exclusion of alternate CLD etiologies; (4) history of alcohol consumption < 40 g/day (men) or < 30 g/day (women); (5) no clinical or biochemical evidence for cirrhosis
 David et al., 2009 [8] Adults with NAFLD (≥ 5% steatosis) and complete biopsy results, from two NASH CRNc studies: (1) the NAFLD Database (observational cohort study); and (2) the PIVENS trial NAFLD n = 713
 Definite NASH n = 436 (61%)
 Borderline NASH n = 141 (20%)
 Definitely not NASH n = 136 (19%)
Definite NASH n = 436
 Mean age 49.3 y (SD 11.9)
 Males 33.0%
 Cirrhosis, n = 49 (11.2%)
 Sayiner et al., 2016 [13] Patients with an established histological diagnosis of NAFLD with or without cirrhosis. Patients with viral hepatitis, with significant alcohol intake (> 20 g/day for men, > 10 g/day for women), and with other causes of CLD were excluded NAFLD with cirrhosis n = 30d
 Mean age 54.1 y (SD 10.8)
 Males 56.7%
NAFLD without cirrhosis n = 59
 Mean age 49.1 y (SD 10.4)
 Males 37.3%
 Tapper and Lai, 2016 [14] Patients with NAFLD enrolled in a NAFLD registry (Beth Israel Deaconess Medical Center, Boston, MA) (Excluded other CLDs and daily consumption of > 20 g alcohol) NAFLD n = 151
 NASH n = 67 (44%)
 Advanced fibrosis n = 30 (20%) [Age not reported for NASH patients]
No significant weight loss achieved n = 104
 NASH n = 42 (44%)
 Mean NFS –1.41 (SD 1.80)
 Mean FIB-4 index 1.47 (SD 0.99)
 Advanced fibrosis n = 20 (20%)
Significant weight loss achieved n = 47
 NASH n = 25 (54%)
 Mean NFS –1.95 (SD 1.62)
 Mean FIB-4 index 1.29 (SD 0.80)
 Advanced fibrosis n = 10 (21.7%)
Biopsy (NAS 5–8)
Interventional trials reporting HRQoL impact of pharmacological therapies for NASH
 Chande et al. 2006 [15] Adults (18–75 y) with NASH and persistently (≥ 3 months) abnormal ALT and/or AST. (Excluded overuse of alcohol [20 g/week]; other CLDs or other hepatic, GI, renal, cardiovascular, neurological, or hematological disorder; receipt of herbal treatments or dietary supplements except multivitamins/minerals) NASH n = 8
YHK group n = 5
 Mean age 56 y (SD 7)
 Males 20%
Placebo group n = 3
 Mean age 47 y (SD 12)
 Males 67%
Cirrhosis status not stated
 Sanyal et al. 2010 [16] Adults without DM with NASH. Definite or possible steatohepatitis with an activity score of ≥ 5, or definite steatohepatitis with an activity score of 4. A score of ≥ 1 for hepatocellular ballooning was required. (Excluded cirrhosis, other CLDs, alcohol consumption [> 20 g/day women; > 30 g/day men] for ≥ 3 consecutive months during the previous 5 y; receipt of drugs known to cause steatohepatitis) NASH n = 247
 Mean age 46.3 y (SD 11.9)
 Males 40%
Pioglitazone n = 80
 Vitamin E n = 84
 Placebo n = 83
(Cirrhosis excluded)
Qualitative research in patients with NASH
 Palsgrove et al. 2016 [17] Patients (≥ 18 y) with NASH, recruited through local clinicians and disease support groups NASH n = 132e
 Mean age 50.2 y
 Males 47%
Self-reported cirrhosis n = 17 (13%)
Self-reported diagnosis of NASH from a healthcare provider
  1. ALT, alanine aminotransferase; AST, aspartate aminotransferase; CLD, chronic liver disease; DM, diabetes mellitus; FIB-4, Fibrosis-4 [index]; GI, gastrointestinal; LT, liver transplant; NAFLD, nonalcoholic fatty liver disease; NAS, NAFLD Activity Score; NASH, nonalcoholic steatohepatitis; NFS, NAFLD Fibrosis Score; PIVENS, Pioglitazone versus Vitamin E versus Placebo for the Treatment of Nondiabetic Patients with Nonalcoholic Steatohepatitis [trial]; YHK, Yo Jyo Hen Shi Ko
  2. aWare JE Jr. SF-36 Health Survey manual and interpretation guide. Boston: The Health Institute, New England Medical Centre, 1993
  3. bBondini S, Kallman J, Dan A, Younoszai Z, Ramsey L, Nader F, Younossi ZM (2007) Health-related quality of life in patients with chronic hepatitis B. Liver Int 27:1119–1125
  4. cThe multicenter study by David et al. (2009) derived baseline HRQoL data (SF-36) from two studies conducted by the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN), comprising a total of eight clinical centers and a central data coordinating center. It was established by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to assess the natural history, pathogenesis, and therapy of NAFLD in the USA. The first study in David et al. (2009) was a NAFLD Database (observational cohort study), and the second was a randomized controlled trial (Pioglitazone versus Vitamin E versus Placebo for the Treatment of Nondiabetic Patients with Nonalcoholic Steatohepatitis [PIVENS])
  5. dPatients with cirrhotic NAFLD in Sayiner et al. (2016) were considered in this literature review to represent NASH
  6. eIn the qualitative study (Palsgrove et al. 2016), the data in this review have been taken from the conference poster in which the patient number is 132. In the conference abstract, the patient number is 135