Validation of the Chronic Liver Disease Questionnaire for MASH (CLDQ-MASH)
Background & Aims: The new nomenclature for metabolic dysfunction-associated steatohepatitis (MASH) requires presence of steatohepatitis in the context of at least one cardiometabolic risk. Having a health-related quality of life (HRQL) instrument validated specifically in patients with MASH...
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Elsevier
2025-03-01
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| author | Zobair M. Younossi Maria Stepanova Issah Younossi Andrei Racila |
| author_facet | Zobair M. Younossi Maria Stepanova Issah Younossi Andrei Racila |
| author_sort | Zobair M. Younossi |
| collection | DOAJ |
| description | Background & Aims: The new nomenclature for metabolic dysfunction-associated steatohepatitis (MASH) requires presence of steatohepatitis in the context of at least one cardiometabolic risk. Having a health-related quality of life (HRQL) instrument validated specifically in patients with MASH is important for clinical research and clinical trials. Methods: From our non-alcoholic fatty liver disease/non-alcoholic steatohepatitis (NAFLD/NASH) database, patients who met the definition of MASH according to the new criteria were selected. Subjects had completed the Chronic Liver Disease Questionnaire for NAFLD/NASH (CLDQ-NAFLD/NASH) and other HRQL instruments (Functional Assessment of Chronic Illness Therapy – Fatigue [FACIT-F], Short-Form 36 [SF-36]), and had available clinico-laboratory data including fibrosis non-invasive tests (NITs). The CLDQ-MASH was developed following a standard pipeline and subsequently validated in a non-overlapping sample. Results: There were 4,213 MASH patients included: age 56 ± 11 years, 44% male, 65% type 2 diabetes, 69% advanced fibrosis (F3–F4). The patients with MASH were split 1:2 into a training set used for development of CLDQ-MASH and a testing set used for validation using standard pipeline. After item reduction and exploratory factor analysis with the training set (>90% variance), the CLDQ-MASH contained 35 items and seven domains. With the non-overlapping testing set, CLDQ-MASH demonstrated excellent face validity, internal consistency (all Cronbach’s alpha >0.78), and high correlations with relevant domains of SF-36, FACIT-F (p <0.01). Known-groups validity assessment confirmed that CLDQ-MASH can discriminate patients based on liver disease severity (histology- and NIT-based) and the presence of non-hepatic comorbidities (obesity, type 2 diabetes, depression, clinically overt fatigue, insomnia). In a subsample of subjects with 1-year follow-up, the instrument was responsive to changes in Enhanced Liver Fibrosis® scores and liver stiffness measurements (p <0.05 for four to six domains). Conclusions: The CLDQ-MASH can be used as a valid disease-specific HRQL instrument for patients with MASH. Impact and implications:: The new criteria for metabolic dysfunction-associated steatohepatitis (MASH) are different from those previously used for non-alcoholic steatohepatitis so the evidence collected for the previous criteria need to be revisited, including disease-specific instruments for assessment of health-related quality of life. In patients with MASH, Chronic Liver Disease Questionnaire-MASH (CLDQ-MASH; 35 items, seven domains) has excellent psychometric properties including its internal consistency and various aspects of validity, and is responsive to changes in liver disease severity indicators. The CLDQ-MASH can be used as a valid disease-specific health-related quality of life instrument for MASH in clinical research and clinical trials. |
| format | Article |
| id | doaj-art-743a7cb166d9465b96a65ad01ffb4e52 |
| institution | Kabale University |
| issn | 2589-5559 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | Elsevier |
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| series | JHEP Reports |
| spelling | doaj-art-743a7cb166d9465b96a65ad01ffb4e522025-02-02T05:29:11ZengElsevierJHEP Reports2589-55592025-03-0173101276Validation of the Chronic Liver Disease Questionnaire for MASH (CLDQ-MASH)Zobair M. Younossi0Maria Stepanova1Issah Younossi2Andrei Racila3Corresponding author. Address: Center for Outcomes Research in Liver Diseases, 2411 I. St NW, Washington DC, 20037, USA.; Center for Outcomes Research in Liver Disease, Washington DC, USACenter for Outcomes Research in Liver Disease, Washington DC, USACenter for Outcomes Research in Liver Disease, Washington DC, USACenter for Outcomes Research in Liver Disease, Washington DC, USABackground & Aims: The new nomenclature for metabolic dysfunction-associated steatohepatitis (MASH) requires presence of steatohepatitis in the context of at least one cardiometabolic risk. Having a health-related quality of life (HRQL) instrument validated specifically in patients with MASH is important for clinical research and clinical trials. Methods: From our non-alcoholic fatty liver disease/non-alcoholic steatohepatitis (NAFLD/NASH) database, patients who met the definition of MASH according to the new criteria were selected. Subjects had completed the Chronic Liver Disease Questionnaire for NAFLD/NASH (CLDQ-NAFLD/NASH) and other HRQL instruments (Functional Assessment of Chronic Illness Therapy – Fatigue [FACIT-F], Short-Form 36 [SF-36]), and had available clinico-laboratory data including fibrosis non-invasive tests (NITs). The CLDQ-MASH was developed following a standard pipeline and subsequently validated in a non-overlapping sample. Results: There were 4,213 MASH patients included: age 56 ± 11 years, 44% male, 65% type 2 diabetes, 69% advanced fibrosis (F3–F4). The patients with MASH were split 1:2 into a training set used for development of CLDQ-MASH and a testing set used for validation using standard pipeline. After item reduction and exploratory factor analysis with the training set (>90% variance), the CLDQ-MASH contained 35 items and seven domains. With the non-overlapping testing set, CLDQ-MASH demonstrated excellent face validity, internal consistency (all Cronbach’s alpha >0.78), and high correlations with relevant domains of SF-36, FACIT-F (p <0.01). Known-groups validity assessment confirmed that CLDQ-MASH can discriminate patients based on liver disease severity (histology- and NIT-based) and the presence of non-hepatic comorbidities (obesity, type 2 diabetes, depression, clinically overt fatigue, insomnia). In a subsample of subjects with 1-year follow-up, the instrument was responsive to changes in Enhanced Liver Fibrosis® scores and liver stiffness measurements (p <0.05 for four to six domains). Conclusions: The CLDQ-MASH can be used as a valid disease-specific HRQL instrument for patients with MASH. Impact and implications:: The new criteria for metabolic dysfunction-associated steatohepatitis (MASH) are different from those previously used for non-alcoholic steatohepatitis so the evidence collected for the previous criteria need to be revisited, including disease-specific instruments for assessment of health-related quality of life. In patients with MASH, Chronic Liver Disease Questionnaire-MASH (CLDQ-MASH; 35 items, seven domains) has excellent psychometric properties including its internal consistency and various aspects of validity, and is responsive to changes in liver disease severity indicators. The CLDQ-MASH can be used as a valid disease-specific health-related quality of life instrument for MASH in clinical research and clinical trials.http://www.sciencedirect.com/science/article/pii/S2589555924002805Chronic liver diseaseMetabolic liver diseaseNASHNAFLDQuality of lifeMASH |
| spellingShingle | Zobair M. Younossi Maria Stepanova Issah Younossi Andrei Racila Validation of the Chronic Liver Disease Questionnaire for MASH (CLDQ-MASH) JHEP Reports Chronic liver disease Metabolic liver disease NASH NAFLD Quality of life MASH |
| title | Validation of the Chronic Liver Disease Questionnaire for MASH (CLDQ-MASH) |
| title_full | Validation of the Chronic Liver Disease Questionnaire for MASH (CLDQ-MASH) |
| title_fullStr | Validation of the Chronic Liver Disease Questionnaire for MASH (CLDQ-MASH) |
| title_full_unstemmed | Validation of the Chronic Liver Disease Questionnaire for MASH (CLDQ-MASH) |
| title_short | Validation of the Chronic Liver Disease Questionnaire for MASH (CLDQ-MASH) |
| title_sort | validation of the chronic liver disease questionnaire for mash cldq mash |
| topic | Chronic liver disease Metabolic liver disease NASH NAFLD Quality of life MASH |
| url | http://www.sciencedirect.com/science/article/pii/S2589555924002805 |
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