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Lookup NU author(s): Dr Matt Breckons, Professor Luke ValeORCiD, Dr Lorraine McSweeneyORCiD, Professor Quentin AnsteeORCiD
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© The Author(s) 2025.Background: NASH-CHECK is a patient-reported outcome measure (PROM) that assesses symptoms and broader health-related quality of life (HRQOL) impacts of metabolic dysfunction–associated steatohepatitis (MASH), previously called non-alcoholic steatohepatitis (NASH). The measure was initially developed and validated for patients with non-cirrhotic MASH. This study describes an evaluation of the suitability of NASH-CHECK for patients with compensated cirrhotic MASH. Methodology: Concept elicitation (CE) interviews were conducted with patients with clinically confirmed compensated cirrhotic MASH in the United States (US) and United Kingdom (UK) to determine the symptom burden and broader HRQOL impact of MASH. Symptoms and broader HRQOL impacts identified during analysis of the CE data were compared with the key concepts included in NASH-CHECK; any symptoms reported in the CE interviews but not reflected in NASH-CHECK were reviewed for relevance by clinical experts. The content validity of NASH-CHECK was evaluated further via cognitive debriefing (CD) interviews conducted with patients with compensated cirrhotic MASH in the US and UK. Results: CE interviews were conducted with 33 patients with compensated cirrhotic MASH (US = 9, UK = 24; 60.6% female; mean age, 64.3 years). Key symptoms described were similar to those reported by patients with non-cirrhotic MASH identified during the development of NASH-CHECK; these included abdominal pain, abdominal bloating, itch, fatigue, sleeping difficulties, and cognitive symptoms. Other key HRQOL impacts included activity limitations and emotional, social, relationship, and work impacts. All key symptom and broader HRQOL impacts reported by patients with compensated cirrhotic MASH are currently included in NASH-CHECK, and no additional symptoms or HRQOL impacts reported during the CE interviews were deemed relevant for inclusion. CD interviews were conducted with 17 patients with compensated cirrhotic MASH (US = 8, UK = 9; 47.1% female; mean age, 62.8 years). Patient feedback on NASH-CHECK content confirmed that the concepts captured by the items were considered important, relevant, and comprehensive for addressing the impact of compensated cirrhotic MASH. Conclusions: The results support the content validity of NASH-CHECK for patients with compensated cirrhotic MASH, demonstrating that NASH-CHECK is a suitable PROM for use in clinical trials, studies, and practice for this patient population.
Author(s): Doward LC, Breckons M, Balp M-M, Twiss J, Vale L, McSweeney L, Brass CA, Anstee QM, Sanyal AJ
Publication type: Article
Publication status: Published
Journal: Journal of Patient-Reported Outcomes
Year: 2025
Volume: 9
Issue: 1
Print publication date: 01/12/2025
Online publication date: 01/07/2025
Acceptance date: 15/04/2025
Date deposited: 15/07/2025
ISSN (electronic): 2509-8020
Publisher: Springer Science and Business Media Deutschland GmbH
URL: https://doi.org/10.1186/s41687-025-00881-6
DOI: 10.1186/s41687-025-00881-6
Data Access Statement: Data are not available
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