Instrument Information

• NASH-CHECK is a patient-reported outcome (PRO) measure designed to assess symptoms and health-related quality of life (HRQOL) from the perspective of patients with noncirrhotic and compensated cirrhotic non-alcoholic steatohepatitis (NASH). The measure has 28 items, assessing symptoms (9 items), and HRQOL (19 items), all with a recall period of the ‘past 7 days’.
• NASH CHECK was developed originally for patients with noncirrhotic NASH and fibrosis stages 1 to 3, based on a substantial body of qualitative research conducted with patients in the United States, and supported by further qualitative research conducted with patients across multiple countries (Doward et al, 2021). Instrument development was guided by an international NASH-PRO Task Force composed of clinical experts, patient advocacy advisors, patient-centered outcomes researchers, and industry representatives.
• NASH-CHECK is also the key biomarker designed to inform on the patient-experience for the Liver Investigation: Testing Marker Utility in Steatohepatitis (LITMUS) program funded by the European Innovative Medicines Initiative 2 Joint Undertaking. Additional qualitative research conducted with patients with compensated cirrhotic NASH and fibrosis stage 4, confirmed the content validity and acceptability of the measure for this patient group.
• NASH-CHECK dimensional structure and broader psychometric properties were confirmed for a noncirrhotic NASH patient population using data available from a phase 2 clinical trial. Future analyses will be used confirm the psychometric properties for a compensated cirrhotic NASH patient population.
• NASH-CHECK is suitable for use in clinical trials and clinical studies with adult patients with non-cirrhotic NASH (fibrosis levels F1 through F3) or compensated cirrhotic NASH (fibrosis level F4).

Click here to find out more about LITMUS (https://litmus-project.eu/)