REFERENCES
1. Younossi ZM, Golabi P, Paik JM, Henry A, Van Dongen C, Henry L. The global epidemiology of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH): a systematic review. Hepatology 2023;77:1335-47.
2. Paik JM, Henry L, Younossi Y, Ong J, Alqahtani S, Younossi ZM. The burden of nonalcoholic fatty liver disease (NAFLD) is rapidly growing in every region of the world from 1990 to 2019. Hepatol Commun 2023;7:e0251.
3. Younossi ZM, Stepanova M, Younossi Y, et al. Epidemiology of chronic liver diseases in the USA in the past three decades. Gut 2020;69:564-8.
4. Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology 2016;64:73-84.
5. Sanyal AJ, Van Natta ML, Clark J, et al; NASH Clinical Research Network (CRN). Prospective study of outcomes in adults with nonalcoholic fatty liver disease. N Engl J Med 2021;385:1559-69.
6. Simon TG, Roelstraete B, Khalili H, Hagström H, Ludvigsson JF. Mortality in biopsy-confirmed nonalcoholic fatty liver disease: results from a nationwide cohort. Gut 2021;70:1375-82.
7. Park H, Dawwas GK, Liu X, Nguyen MH. Nonalcoholic fatty liver disease increases risk of incident advanced chronic kidney disease: a propensity-matched cohort study. J Intern Med 2019;286:711-22.
8. Younossi ZM, Paik JM, Stepanova M, Ong J, Alqahtani S, Henry L. Clinical profiles and mortality rates are similar for metabolic dysfunction-associated steatotic liver disease and non-alcoholic fatty liver disease. J Hepatol 2024;80:694-701.
9. Golabi P, Paik JM, Eberly K, de Avila L, Alqahtani SA, Younossi ZM. Causes of death in patients with non-alcoholic fatty liver disease (NAFLD), alcoholic liver disease and chronic viral hepatitis B and C. Ann Hepatol 2022;27:100556.
10. Adams LA, Anstee QM, Tilg H, Targher G. Non-alcoholic fatty liver disease and its relationship with cardiovascular disease and other extrahepatic diseases. Gut 2017;66:1138-53.
11. Ballestri S, Mantovani A, Girolamo MD, Baldelli E, Capitelli M, Lonardo A. Liver fibrosis in nonalcoholic fatty liver disease patients: noninvasive evaluation and correlation with cardiovascular disease and mortality. Metab Target Organ Damage 2023;3:1.
12. Kalligeros M, Henry L, Younossi ZM. Metabolic dysfunction-associated steatotic liver disease and its link to cancer. Metabolism 2024;160:156004.
13. Mantovani A, Petracca G, Beatrice G, et al. Non-alcoholic fatty liver disease and increased risk of incident extrahepatic cancers: a meta-analysis of observational cohort studies. Gut 2022;71:778-88.
14. Ekstedt M, Hagström H, Nasr P, et al. Fibrosis stage is the strongest predictor for disease-specific mortality in NAFLD after up to 33 years of follow-up. Hepatology 2015;61:1547-54.
15. Younossi ZM, Stepanova M, Ong J, et al. Nonalcoholic steatohepatitis is the most rapidly increasing indication for liver transplantation in the United States. Clin Gastroenterol Hepatol 2021;19:580-9.e5.
16. Noureddin M, Vipani A, Bresee C, et al. NASH leading cause of liver transplant in women: updated analysis of indications for liver transplant and ethnic and gender variances. Am J Gastroenterol 2018;113:1649-59.
17. Younossi ZM, Yilmaz Y, Yu ML, et al; Global NASH Council. Clinical and patient-reported outcomes from patients with nonalcoholic fatty liver disease across the world: data from the global non-alcoholic steatohepatitis (NASH)/non-alcoholic fatty liver disease (NAFLD) registry. Clin Gastroenterol Hepatol 2022;20:2296-306.e6.
18. Stepanova M, Henry L, Younossi ZM. Economic burden and patient-reported outcomes of nonalcoholic fatty liver disease. Clin Liver Dis 2023;27:483-513.
19. Younossi ZM, Paik JM, Henry L, et al. The growing economic and clinical burden of nonalcoholic steatohepatitis (NASH) in the United States. J Clin Exp Hepatol 2023;13:454-67.
20. US Food and Drug Administration. Guidance for industry: patient-reported outcome measures: use in medical product development to support labelling claims. Available from: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf. [Last accessed on 19 Nov 2024].
21. Mercieca-Bebber R, King MT, Calvert MJ, Stockler MR, Friedlander M. The importance of patient-reported outcomes in clinical trials and strategies for future optimization. Patient Relat Outcome Meas 2018;9:353-67.
23. Horsman J, Furlong W, Feeny D, Torrance G. The Health Utilities Index (HUI): concepts, measurement properties and applications. Health Qual Life Outcomes 2003;1:54.
24. van der Plas SM, Hansen BE, de Boer JB, et al. Generic and disease-specific health related quality of life of liver patients with various aetiologies: a survey. Qual Life Res 2007;16:375-88.
25. Younossi ZM, Kremer AE, Swain MG, et al. Assessment of fatigue and its impact in chronic liver disease. J Hepatol 2024;81:726-42.
26. Guyatt G, Walter S, Norman G. Measuring change over time: assessing the usefulness of evaluative instruments. J Chronic Dis 1987;40:171-8.
27. Cook CE. Clinimetrics corner: the minimal clinically important change score (MCID): a necessary pretense. J Man Manip Ther 2008;16:E82-3.
28. US Food and Drug Administration. Incorporating clinical outcome assessments into endpoints for regulatory decision-making. Available from: https://www.fda.gov/media/132505/download. [Last accessed on 19 Nov 2024].
29. Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials 1989;10:407-15.
30. Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-83.
31. Devlin NJ, Brooks R. EQ-5D and the EuroQol group: past, present and future. Appl Health Econ Health Policy 2017;15:127-37.
32. Coretti S, Ruggeri M, McNamee P. The minimum clinically important difference for EQ-5D index: a critical review. Expert Rev Pharmacoecon Outcomes Res 2014;14:221-33.
33. EUROQQOL. EQ-5D-5L. Available from: https://euroqol.org/information-and-support/euroqol-instruments/eq-5d-5l/. [Last accessed on 20 Nov 2024].
34. Younossi ZM, Guyatt G, Kiwi M, Boparai N, King D. Development of a disease specific questionnaire to measure health related quality of life in patients with chronic liver disease. Gut 1999;45:295-300.
35. Younossi ZM, Stepanova M, Henry L. Performance and validation of chronic liver disease questionnaire-hepatitis C version (CLDQ-HCV) in clinical trials of patients with chronic hepatitis C. Value Health 2016;19:544-51.
36. Younossi ZM, Stepanova M, Younossi I, Racila A. Development and validation of a hepatitis B-specific health-related quality-of-life instrument: CLDQ-HBV. J Viral Hepat 2021;28:484-92.
37. Younossi ZM, Stepanova M, Henry L, et al. A disease-specific quality of life instrument for non-alcoholic fatty liver disease and non-alcoholic steatohepatitis: CLDQ-NAFLD. Liver Int 2017;37:1209-18.
38. Younossi ZM, Stepanova M, Younossi I, Racila A. Development and validation of a primary sclerosing cholangitis-specific health-related quality of life instrument: CLDQ-PSC. Hepatol Commun 2023;7:e0049.
39. Younossi ZM, Stepanova M, Younossi I, Racila A. Validation of a primary biliary cholangitis-specific version of chronic liver disease questionnaire: CLDQ-PBC. Clin Transl Gastroenterol 2024;15:e1.
40. Younossi ZM, Stepanova M, Younossi I, Racila A. Validation of chronic liver disease questionnaire for nonalcoholic steatohepatitis in patients with biopsy-proven nonalcoholic steatohepatitis. Clin Gastroenterol Hepatol 2019;17:2093-100.e3.
41. Schulz KH, Kroencke S, Ewers H, Schulz H, Younossi ZM. The factorial structure of the chronic liver disease questionnaire (CLDQ). Qual Life Res 2008;17:575-84.
42. Gralnek IM, Hays RD, Kilbourne A, et al. 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 2000;95:3552-65.
43. Kanwal F, Spiegel BM, Hays RD, et al. Prospective validation of the short form liver disease quality of life instrument. Aliment Pharmacol Ther 2008;28:1088-101.
44. FACIT.org. Functional assessment of chronic illness therapy - fatigue scale (FACIT-fatigue). Available from: https://www.facit.org/measures/facit-fatigue. [Last accessed on 19 Nov 2024].
45. Kleinman L, Zodet MW, Hakim Z, et al. Psychometric evaluation of the fatigue severity scale for use in chronic hepatitis C. Qual Life Res 2000;9:499-508.
46. Fisk JD, Ritvo PG, Ross L, Haase DA, Marrie TJ, Schlech WF. Measuring the functional impact of fatigue: initial validation of the fatigue impact scale. Clin Infect Dis 1994;18 Suppl 1:S79-83.
47. Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmaco economics 1993;4:353-65.
48. Younossi ZM, Golabi P, Henry L. A comprehensive review of patient-reported outcomes in patients with chronic liver diseases. J Clin Gastroenterol 2019;53:331-41.
49. Verma M, Paik JM, Younossi I, Tan D, Abdelaal H, Younossi ZM. The impact of hepatocellular carcinoma diagnosis on patients’ health-related quality of life. Cancer Med 2021;10:6273-81.
50. Younossi Z, Aggarwal P, Shrestha I, et al. The burden of non-alcoholic steatohepatitis: a systematic review of health-related quality of life and patient-reported outcomes. JHEP Rep 2022;4:100525.
51. Yamamura S, Nakano D, Hashida R, et al. Patient-reported outcomes in patients with non-alcoholic fatty liver disease: a narrative review of chronic liver disease questionnaire-non-alcoholic fatty liver disease/non-alcoholic steatohepatitis. J Gastroenterol Hepatol 2021;36:629-36.
52. Barberá A, White TM, Arora AK, Henry L, Lazarus JV, Younossi ZM. Patient-reported outcomes in metabolic dysfunction-associated steatotic liver disease. Semin Liver Dis 2024;Online ahead of print.
53. Younossi ZM, Stepanova M, Myers RP, Younossi I, Henry L. The potential role of fatigue in identifying patients with NASH and advanced fibrosis who experience disease progression. Clin Gastroenterol Hepatol 2023;21:970-7.e1.
54. McSweeney L, Breckons M, Fattakhova G, et al. Health-related quality of life and patient-reported outcome measures in NASH-related cirrhosis. JHEP Rep 2020;2:100099.
55. Younossi ZM, Paik JM, Golabi P, Younossi Y, Henry L, Nader F. The impact of fatigue on mortality of patients with non-alcoholic fatty liver disease: data from National health and nutrition examination survey 2005-2010 and 2017-2018. Liver Int 2022;42:2646-61.
56. Weinstein AA, De Avila L, Kannan S, et al. Interrelationship between physical activity and depression in nonalcoholic fatty liver disease. World J Hepatol 2022;14:612-22.
57. Younossi ZM, Zelber-Sagi S, Henry L, Gerber LH. Lifestyle interventions in nonalcoholic fatty liver disease. Nat Rev Gastroenterol Hepatol 2023;20:708-22.
58. Gerber LH, Weinstein AA, Mehta R, Younossi ZM. Importance of fatigue and its measurement in chronic liver disease. World J Gastroenterol 2019;25:3669-83.
59. Austin P, Gerber L, Paik JM, Price JK, Escheik C, Younossi ZM. Aerobic capacity and exercise performance in nonalcoholic fatty liver disease. J Sports Med Phys Fitness 2019;59:1376-88.
60. Canada JM, Abbate A, Collen R, et al. Relation of hepatic fibrosis in nonalcoholic fatty liver disease to left ventricular diastolic function and exercise tolerance. Am J Cardiol 2019;123:466-73.
61. Mascaró CM, Bouzas C, Montemayor S, et al. Association between stages of hepatic steatosis and physical activity performance in adults with metabolic syndrome: a cross-sectional analysis in FLIPAN study. Nutrients 2022;14:1790.
62. Weinstein AA, Escheik C, Oe B, Price JK, Gerber LH, Younossi ZM. Perception of effort during activity in patients with chronic hepatitis C and nonalcoholic fatty liver disease. PM R 2016;8:28-34.
63. Younossi ZM, Stepanova M, Noureddin M, et al. Improvements of fibrosis and disease activity are associated with improvement of patient-reported outcomes in patients with advanced fibrosis due to nonalcoholic steatohepatitis. Hepatol Commun 2021;5:1201-11.
64. Younossi ZM, Stepanova M, Taub RA, Barbone JM, Harrison SA. Hepatic fat reduction due to resmetirom in patients with nonalcoholic steatohepatitis is associated with improvement of quality of life. Clin Gastroenterol Hepatol 2022;20:1354-61.e7.
65. Schomerus G, Leonhard A, Manthey J, et al. The stigma of alcohol-related liver disease and its impact on healthcare. J Hepatol 2022;77:516-24.
66. Wahlin S, Andersson J. Liver health literacy and social stigma of liver disease: a general population e-survey. Clin Res Hepatol Gastroenterol 2021;45:101750.
67. Batchelder AW, Heo M, Foley JD, et al; HERO Study Group. Shame and stigma in association with the HCV cascade to cure among people who inject drugs. Drug Alcohol Depend 2023;253:111013.
68. Smith-Palmer J, Cerri K, Sbarigia U, et al. Impact of stigma on people living with chronic hepatitis B. Patient Relat Outcome Meas 2020;11:95-107.
69. Younossi ZM, Alqahtani SA, Alswat K, et al; Global NASH Council. Global survey of stigma among physicians and patients with nonalcoholic fatty liver disease. J Hepatol 2024;80:419-30.
70. Younossi ZM, AlQahtani SA, Funuyet-Salas J, et al; Global NASH Council. The impact of stigma on quality of life and liver disease burden among patients with nonalcoholic fatty liver disease. JHEP Rep 2024;6:101066.
71. UNOS. Data and trends. Available from: https://unos.org/data/. [Last accessed on 19 Nov 2024].
72. Serrano MT, Sabroso S, Esteban LM, et al. Mortality and causes of death after liver transplantation: analysis of sex differences in a large nationwide cohort. Transpl Int 2022;35:10263.
73. Vitale A, Trapani S, Russo FP, et al; Associazione Italiana per lo Studio del Fegato (AISF).; Società Italiana Trapianti d’Organo (SITO).; Centro Nazionale Trapianti (CNT). Waiting list mortality and 5-year transplant survival benefit of patients with MASLD: an Italian liver transplant registry study. JHEP Rep 2024;6:101147.
74. Stepanova M, Henry L, Garg R, Kalwaney S, Saab S, Younossi Z. Risk of de novo post-transplant type 2 diabetes in patients undergoing liver transplant for non-alcoholic steatohepatitis. BMC Gastroenterol 2015;15:175.
