BACKGROUND: NASH-CHECK is a patient-reported outcomes measure that assesses symptoms and health-related quality of life (HRQOL) impacts of nonalcoholic steatohepatitis (NASH), developed and validated for patients with noncirrhotic NASH . This study describes an evaluation of the suitability of NASH-CHECK for patients with compensated cirrhotic NASH .
METHODS: Concept elicitation (CE) interviews were conducted with patients with clinically confirmed compensated cirrhotic NASH in the United States (US), United Kingdom (UK), and Canada (CA) to determine the patient-perceived impact of NASH . Key themes emerging from analysis of CE data were compared with the key concepts included in NASH-CHECK . The content validity of NASH-CHECK was evaluated further via cognitive debriefing (CD) interviews conducted with patients with compensated cirrhotic NASH in the US and UK.
RESULTS: CE interviews were conducted with 38 patients with compensated cirrhotic NASH (UK = 24, US = 11, CA = 3; 61% female, mean/standard deviation age = 63.4/7.9 years). The impacts reported were comparable across the three samples and were similar to those reported by patients with noncirrhotic NASH . Key symptoms described included abdominal pain, abdominal bloating, itch, fatigue, sleeping difficulties, and cognitive symptoms . Key HRQOL impacts included activity limitations and emotional, social, relationship, and work impacts . All key symptom and HRQOL impacts reported by patients with compensated cirrhotic NASH are currently included in NASH-CHECK . CD interviews were conducted with 17 patients with compensated cirrhotic NASH (UK = 9, US = 8, 77% female, mean/standard deviation age = 62.8/7.9 years). Patient feedback on NASH-CHECK content for UK and US patients confirmed that the concepts captured by the items were considered important, relevant, and comprehensive for addressing the impact of compensated cirrhotic NASH . Patients considered the instructions, response format, and items to be clear, appropriate, and comprehensible .
CONCLUSION: The results support the content validity of NASH-CHECK for patients with compensated cirrhotic NASH, demonstrating that NASH-CHECK is a suitable patient-reported outcomes measure for use in clinical trials, studies, and practice for this patient population . Further research is planned to evaluate the psychometric properties of NASH-CHECK in a compensated cirrhotic patient sample.
