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

Autor:	Twiss, James, Whalley, Diane, Doward, Lynda, Balp, Maria-Magdalena, Brass, Clifford A., Cryer, Donna, Sanyal, Arun, Anstee, Quentin M.
Předmět:	RELIABILITY (Personality trait) STATISTICAL reliability RESEARCH methodology evaluation HEALTH outcome assessment NON-alcoholic fatty liver disease HEALTH status indicators QUANTITATIVE research PSYCHOMETRICS PATIENTS' attitudes MULTITRAIT multimethod techniques QUALITY of life DESCRIPTIVE statistics FACTOR analysis RESEARCH funding EVALUATION SYMPTOMS
Zdroj:	Journal of Patient-Reported Outcomes; 7/14/2023, Vol. 7 Issue 1, p1-14, 14p
Abstrakt:	Background: Standardized 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. Methods: The 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. Results: Data 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. Conclusion: The 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. [ABSTRACT FROM AUTHOR]
Databáze:	Complementary Index
Externí odkaz:	Zobrazit plný text záznamu Full text from SpringerLink