Hepatology communications · 2026
Development and validation of a disease-specific health-related quality of life questionnaire for alcohol-associated liver disease: The CLDQ-ALD.
СтатьяВалидационное исследованиеНазвание и аннотация: Перевод в очереди
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Younossi Zobair M, Stepanova Maria, Younossi Issah, deAvila Leyla
Аннотация
BACKGROUND: Accurate assessment of health-related quality of life (HRQL) is essential in clinical research and therapeutic trials in alcohol-associated liver disease (ALD). The study aimed to develop and validate an ALD-specific HRQL instrument using a standard protocol for disease-specific HRQL instrument development.
METHODS: A comprehensive list of HRQL items was generated based on ALD patients' individual interviews and focus groups, existing HRQL instruments, and input from expert health care providers. Items were reduced through administration to patients with ALD, calculation of item impact scores, assessment of face validity, exploratory factor analysis, and evaluation of within-domain consistency and redundancy. The final Chronic Liver Disease Questionnaire (CLDQ)-ALD instrument underwent initial steps for psychometric validation.
RESULTS: The initial questionnaire comprised 90 items. Across 2 rounds of item reduction, it was completed by 72 patients with ALD (32% <45 y, 69% male, 18% with T2D, 39% cirrhosis, 40% current alcohol use) and reduced to 40 final items. Exploratory factor analysis identified 9 factors explaining 95% of the total variance. Based on the factor loadings, items were assigned to 9 domains (Fatigue, Alcohol, Function, Physical, Abdominal Symptoms, Itching, Sleep, Emotional, and Worry). Face and construct validity were assessed, along with concordance with another validated CLDQ instrument (CLDQ-metabolic dysfunction-associated steatohepatitis). The final CLDQ-ALD demonstrated good to excellent psychometric performance, with high internal consistency (Cronbach α >0.85 across all domains and >0.90 in 5 of 9 domains). Known-groups validity demonstrated mean score differences >0.5 (on a scale 1-7) in relevant domains by sex, presence of T2D, current alcohol use, depression, clinically overt fatigue, and cirrhosis.
CONCLUSIONS: CLDQ-ALD version 1 is a disease-specific HRQL instrument for use in clinical research and therapeutic trials involving patients with ALD.
METHODS: A comprehensive list of HRQL items was generated based on ALD patients' individual interviews and focus groups, existing HRQL instruments, and input from expert health care providers. Items were reduced through administration to patients with ALD, calculation of item impact scores, assessment of face validity, exploratory factor analysis, and evaluation of within-domain consistency and redundancy. The final Chronic Liver Disease Questionnaire (CLDQ)-ALD instrument underwent initial steps for psychometric validation.
RESULTS: The initial questionnaire comprised 90 items. Across 2 rounds of item reduction, it was completed by 72 patients with ALD (32% <45 y, 69% male, 18% with T2D, 39% cirrhosis, 40% current alcohol use) and reduced to 40 final items. Exploratory factor analysis identified 9 factors explaining 95% of the total variance. Based on the factor loadings, items were assigned to 9 domains (Fatigue, Alcohol, Function, Physical, Abdominal Symptoms, Itching, Sleep, Emotional, and Worry). Face and construct validity were assessed, along with concordance with another validated CLDQ instrument (CLDQ-metabolic dysfunction-associated steatohepatitis). The final CLDQ-ALD demonstrated good to excellent psychometric performance, with high internal consistency (Cronbach α >0.85 across all domains and >0.90 in 5 of 9 domains). Known-groups validity demonstrated mean score differences >0.5 (on a scale 1-7) in relevant domains by sex, presence of T2D, current alcohol use, depression, clinically overt fatigue, and cirrhosis.
CONCLUSIONS: CLDQ-ALD version 1 is a disease-specific HRQL instrument for use in clinical research and therapeutic trials involving patients with ALD.