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

Younossi, 2018, Global burden of NAFLD and NASH: trends, predictions, risk factors and prevention, Nat Rev Gastroenterol Hepatol, 15, 11, 10.1038/nrgastro.2017.109 Anstee, 2013, Progression of NAFLD to diabetes mellitus, cardiovascular disease or cirrhosis, Nat Rev Gastroenterol Hepatol, 10, 330, 10.1038/nrgastro.2013.41 McPherson, 2015, Evidence of NAFLD progression from steatosis to fibrosing-steatohepatitis using paired biopsies: implications for prognosis and clinical management, J Hepatol, 62, 1148, 10.1016/j.jhep.2014.11.034 Dulai, 2017, Increased risk of mortality by fibrosis stage in nonalcoholic fatty liver disease: systematic review and meta-analysis, Hepatology, 65, 1557, 10.1002/hep.29085 2016, EASL–EASD–EASO Clinical Practice Guidelines for the management of non-alcoholic fatty liver disease, J Hepatol, 64, 1388, 10.1016/j.jhep.2015.11.004 Chalasani, 2012, The diagnosis and management of non-alcoholic fatty liver disease: practice guideline by the American association for the study of liver diseases, American College of Gastroenterology, and the American Gastroenterological Association, Hepatology, 55, 2005, 10.1002/hep.25762 Temple, 1995, A regulatory authority's opinion about surrogate endpoints 2016 Kleiner, 2005, Design and validation of a histological scoring system for nonalcoholic fatty liver disease, Hepatology, 41, 1313, 10.1002/hep.20701 2011 Sanyal, 2015, Challenges and opportunities in drug and biomarker development for nonalcoholic steatohepatitis: findings and recommendations from an American association for the study of liver diseases–U.S. Food and Drug Administration joint Workshop, Hepatology, 61, 1392, 10.1002/hep.27678 Siddiqui, 2018, Case definitions for inclusion and analysis of endpoints in clinical trials for nonalcoholic steatohepatitis through the lens of regulatory science, Hepatology, 67, 2001, 10.1002/hep.29607 Gutteling, 2007, Overview of research on health-related quality of life in patients with chronic liver disease, Neth J Med, 65, 227 Afendy, 2009, Predictors of health-related quality of life in patients with chronic liver disease, Aliment Pharmacol Ther, 30, 469, 10.1111/j.1365-2036.2009.04061.x 2009 Mahady, 2018, Burden of non-alcoholic fatty liver disease in Australia, J Gastroenterol Hepatol, 33, 1, 10.1111/jgh.14270 McKenna, 2011, Measuring patient-reported outcomes: moving beyond misplaced common sense to hard science, BMC Med, 9, 86, 10.1186/1741-7015-9-86 Twiss, 2017, Development OF a new patient-reported outcome measure for nonalcoholic steatohepatitis: NASH-check, Value Health, 20, A638, 10.1016/j.jval.2017.08.1448 Doward, 2017, Exploring the patient perceived impact of non-alcoholic steatohepatitis, J Hepatol, 66, S422, 10.1016/S0168-8278(17)31208-4 Paisley, 2005, Etext on Health Technology Assessment (HTA) Information Resources Popay, 2006 Mokkink, 2016, The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) and how to select an outcome measurement instrument, Braz J Phys Ther, 20, 105, 10.1590/bjpt-rbf.2014.0143 Sumskiene, 2006, Disease-specific health-related quality of life and its determinants in liver cirrhosis patients in Lithuania, World J Gastroenterol, 12, 7792, 10.3748/wjg.v12.i48.7792 Teixeira, 2005, A new insight into the differences among non-cirrhotic and cirrhotic patients using the liver disease quality of life instrument (LDQOL), Ann Hepatol, 4, 264, 10.1016/S1665-2681(19)32050-2 David, 2009, Quality of life in adults with nonalcoholic fatty liver disease: baseline data from the nonalcoholic steatohepatitis clinical research network, Hepatology, 49, 1904, 10.1002/hep.22868 Kalaitzakis, 2006, Gastrointestinal symptoms in patients with liver cirrhosis: associations with nutritional status and health-related quality of life, Scand J Gastroenterol, 41, 1464, 10.1080/00365520600825117 Sayiner, 2016, Assessment of health utilities and quality of life in patients with non-alcoholic fatty liver disease, BMJ Open Gastroenterol, 3, e000106, 10.1136/bmjgast-2016-000106 Dan, 2007, Health-related quality of life in patients with non-alcoholic fatty liver disease, Aliment Pharmacol Ther, 26, 815, 10.1111/j.1365-2036.2007.03426.x Younossi, 2015, Economic and quality-of-life implications of non-alcoholic fatty liver disease, Pharmacoeconomics, 33, 1245, 10.1007/s40273-015-0316-5 Cortesi, 2014, A comparison between the health-related quality of life reported by the general population and by patients with major liver diseases, Value Health, 17, A369, 10.1016/j.jval.2014.08.835 Kennedy-Martin, 2017, A review of the quality of life burden of non-alcoholic steatohepatitis, ISPOR 22nd Annual International Meeting Marchesini, 2001, Factors associated with poor health-related quality of life of patients with cirrhosis, Gastroenterology, 120, 170, 10.1053/gast.2001.21193 Chatrath, 2012, Prevalence and morbidity associated with muscle cramps in patients with cirrhosis, Am J Med, 125, 1019, 10.1016/j.amjmed.2012.03.012 Nakamura, 2008, Prevalence of esophagogastric varices in patients with non-alcoholic steatohepatitis, Hepatol Res, 38, 572, 10.1111/j.1872-034X.2008.00318.x Stine, 2018, Increased risk of venous thromboembolism in hospitalized patients with cirrhosis due to non-alcoholic steatohepatitis, Clin Transl Gastroenterol, 9, 140, 10.1038/s41424-018-0002-y Elliott, 2013, Functional impairment in alcoholic liver disease and non-alcoholic fatty liver disease is significant and persists over 3 years of follow-up, Dig Dis Sci, 58, 2383, 10.1007/s10620-013-2657-2 Rogal, 2015, Inflammation, psychiatric symptoms, and opioid use are associated with pain and disability in patients with cirrhosis, Clin Gastroenterol Hepatol, 13, 1009, 10.1016/j.cgh.2014.10.029 Rogal, 2013, Pain and opioid use in chronic liver disease, Dig Dis Sci, 58, 2976, 10.1007/s10620-013-2638-5 Madan, 2012, Chronic pain among liver transplant candidates, Prog Transplant, 22, 379, 10.7182/pit2012535 Sobhonslidsuk, 2011, Excessive daytime sleep disorder and fatigue in non-alcoholic fatty liver disease in comparison to cirrhosis, J Gastroenterol Hepatol, 26, 164 Rogal, 2013, Healthcare utilization among patients with cirrhosis: the role of inflammation, medications, pain, and depression, Hepatology, 1, 950A Rogal, 2014, Inflammation and pain-related disability in patients with cirrhosis, Gastroenterology, 1, S909, 10.1016/S0016-5085(14)63308-4 Edula, 2014, Hemorrhagic ascites from spontaneous ectopic mesenteric varices rupture in NASH induced cirrhosis and successful outcome: a case report, World J Gastroenterol, 20, 8292, 10.3748/wjg.v20.i25.8292 Burgos, 2009, Acquired chronic hepatocerebral degeneration due to cirrhosis from non-alcoholic steatohepatitis, Rev Esp Enferm Dig, 101, 806, 10.4321/S1130-01082009001100009 Younossi, 1999, Development of a disease specific questionnaire to measure health related quality of life in patients with chronic liver disease, Gut, 45, 295, 10.1136/gut.45.2.295 Younossi, 2017, A disease-specific quality of life instrument for non-alcoholic fatty liver disease and non-alcoholic steatohepatitis: CLDQ-NAFLD, Liver Int, 37, 1209, 10.1111/liv.13391 Teixeira, 2005, A new insight into the differences among non-cirrhotic and cirrhotic patients using the liver disease quality of life instrument (LDQOL), Ann Hepatol, 4, 264, 10.1016/S1665-2681(19)32050-2 Marchesini, 2009, Nonalcoholic fatty liver disease: disease and comorbidity-effects on quality of life, Nat Rev Gastroenterol Hepatol, 6, 504, 10.1038/nrgastro.2009.142 Simmons, 2007, Discordance in perceptions of barriers to diabetes care between patients and primary care and secondary care, Diabetes Care, 30, 490, 10.2337/dc06-2338 Edula, 2014, Hemorrhagic ascites from spontaneous ectopic mesenteric varices rupture in NASH induced cirrhosis and successful outcome: a case report, World J Gastroenterol, 20, 8292, 10.3748/wjg.v20.i25.8292 Nakamura, 2008, Prevalence of esophagogastric varices in patients with non-alcoholic steatohepatitis, Hepatol Res, 38, 572, 10.1111/j.1872-034X.2008.00318.x Younossi, 2017, Development and validation of a disease-specific health-related quality (HRQL) instrument for patients with non-alcoholic fatty liver disease (NAFLD) and Non-alcoholic Steatohepatitis (NASH): the CLDQ-NAFLD, Hepatology, 64, 118A Gralnek, 2000, Development and evaluation of the liver disease quality of life instrument in persons with advanced, chronic liver disease—the LDQOL 1.0, Am J Gastroenterol, 95, 3552, 10.1111/j.1572-0241.2000.03375.x van der Plas, 2004, The liver disease symptom index 2.0; validation of a disease-specific questionnaire, Qual Life Res, 13, 1469, 10.1023/B:QURE.0000040797.17449.c0 Fisk, 1994, Measuring the functional impact of fatigue: initial validation of the fatigue impact scale, Clin Infect Dis, Suppl 1, S79, 10.1093/clinids/18.Supplement_1.S79 Newton, 2008, Fatigue in non-alcoholic fatty liver disease (NAFLD) is significant and associates with inactivity and excessive daytime sleepiness but not with liver disease severity or insulin resistance, Gut, 57, 807, 10.1136/gut.2007.139303 Newton, 2009, Fatigue and autonomic dysfunction in non-alcoholic fatty liver disease, Clin Auton Res, 19, 319, 10.1007/s10286-009-0031-4 Amtmann, 2012, Comparison of the psychometric properties of two fatigue scales in multiple sclerosis, Rehabil Psychol, 57, 159, 10.1037/a0027890 Ware, 1994 Unal, 2001, A psychometric comparison of health-related quality of life measures in chronic liver disease, J Clin Epidemiol, 54, 587, 10.1016/S0895-4356(00)00372-3 Frith, 2010, Fatigue impact scale, Occup Med, 60, 159, 10.1093/occmed/kqp180 Huber, 2019, Health-related quality of life in nonalcoholic fatty liver disease associates with hepatic inflammation, Clin Gastroenterol Hepatol, 17, 2085, 10.1016/j.cgh.2018.12.016 Younossi, 2017, A disease-specific quality of life instrument for non-alcoholic fatty liver disease and non-alcoholic steatohepatitis: CLDQ-NAFLD, Liver Int, 37, 1209, 10.1111/liv.13391 Abd El-Kader, 2015, Non-alcoholic fatty liver disease: the diagnosis and management, World J Hepatol, 7, 846, 10.4254/wjh.v7.i6.846 Kennedy-Martin, 2018, Health-related quality of life burden of nonalcoholic steatohepatitis: a robust pragmatic literature review, J Patient Rep Outcomes, 2, 28, 10.1186/s41687-018-0052-7 Guyatt, 1989, Measuring quality of life in clinical trials: a taxonomy and review, CMAJ, 140, 1441