Validation of NASH-CHECK: a novel patient-reported outcome measure for nonalcoholic steatohepatitis

Journal of Patient-Reported Outcomes

Research

Donna Cryer¹  Maria-Magdalena Balp²  Clifford A. Brass³  Lynda Doward⁴  James Twiss⁴  Diane Whalley⁴  Quentin M. Anstee⁵  Arun Sanyal⁶ 

[1] Global Liver Institute, Washington, DC, USA;Novartis Pharma AG, Basel, Switzerland;Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA;RTI Health Solutions, M20 2LS, Manchester, UK;Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle Upon Tyne, UK;Newcastle NIHR Biomedical Research Centre, Newcastle Upon Tyne Hospitals NHS Trust, Newcastle Upon Tyne, UK;Virginia Commonwealth University, Richmond, VA, USA;

关键词: Symptoms;    Health-related quality of life (HRQOL);    Reliability;    Validity;    Responsiveness;   

DOI  :  10.1186/s41687-023-00589-5

 received in 2022-11-15, accepted in 2023-05-04,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundStandardized measures for evaluating patients’ experiences with nonalcoholic steatohepatitis (NASH) and their perceived changes with treatment in clinical trials have been limited. To meet this need, a patient-reported outcome (PRO) measure, NASH-CHECK, was developed to evaluate symptoms and health-related quality of life for patients with NASH. The objective of this study was to conduct a quantitative evaluation of the psychometric properties of NASH-CHECK.MethodsThe study used data from a phase 2, randomized controlled trial of adult patients with NASH (NCT02855164). Analyses were conducted to determine the optimal scoring of NASH-CHECK and to evaluate reliability, construct validity, and ability to detect change in NASH-CHECK scale scores.ResultsData were available for 253 patients with NASH (61% female; mean [standard deviation] age = 53 [12] years). Following initial item-level analyses, including correlations and exploratory factor analysis, three items were removed from the measure. Confirmatory factor analysis supported the formation of four multi-item scales (Cognitive Symptoms, Activity Limitations, Social Impact, and Emotional Impact) and five single-item scales (Abdominal Pain, Abdominal Bloating, Fatigue, Sleep, and Itchy Skin). Psychometric analyses of the final NASH-CHECK scales provided support for their internal reliability, test–retest reliability, construct validity, and ability to detect change.ConclusionThe results support NASH-CHECK as a reliable, valid, and responsive measure to assess patients’ perspectives of symptoms and the health-related quality of life impact of NASH in clinical trials and in routine practice.

【 授权许可】

CC BY   
© The Author(s) 2023

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