Liver

55 - Extensive Validation of a Disease-Specific Health Related Quality of Life Instrument in Patients With Biopsy-Proven Non-Alcoholic Steatohepatitis (NASH): Chronic Liver Disease Questionnaire-NASH (CLDQ-NASH)

Wednesday, October 10
8:30 AM - 8:40 AM
Location: Terrace Ballroom 4 (level 400)

Category: Liver
Zobair Younossi, MD, MPH1, Maria Stepanova, PhD2, Issah Younossi, MPH2, Andrei Racila, BS, OCP, MCITP1
1Inova Fairfax Hospital, Falls Church, VA; 2Center for Outcomes Research in Liver Disease, Washington, DC

Award: ACG Governors Award for Excellence in Clinical Research

Introduction: CLDQ-NASH is a disease-specific instrument developed in a systematic fashion for assessment of patient-reported outcomes (PROs) in patients with NASH. It includes 36 items grouped in 6 domains: Activity, Abdominal, Emotional, Fatigue, Systemic, and Worry domains, all scored on a Likert scale 1-7. Our aim was to validate CLDQ-NASH in a large group of patients with biopsy-proven NASH.

Methods: Patients with biopsy-proven NASH were enrolled in two phase-3 clinical trials. CLDQ-NASH and other PRO instruments [Short Form-36 (SF-36), EQ-5D, Work Productivity and Activity Index (WPAI)] were administered before treatment initiation. A standard PRO instrument validation pipeline with interval consistency, construct validity, discriminant validity and convergent validity assessments were applied.

Results: 1664 patients with biopsy-proven NASH completed CLDQ-NASH and other PRO instruments: 58±9 years old, 40% male, 48% with cirrhosis, 69% with type 2 diabetes. The domains of CLDQ-NASH demonstrated good to excellent internal consistency: Cronbach’s alphas 0.80-0.94, item-to-own domain correlations >0.50 for 33/36 items. Confirmatory factor analysis verified the construct validity for 5 out of 6 original domains. Known groups validity tests suggest that the instrument is consistently able to discriminate between NASH patients with cirrhosis vs. bridging fibrosis (all but one p<0.02), with and without obesity (all but one p<0.001), with or without psychiatric comorbidities (all p<0.0001), with or without fatigue (all p<0.001), and with or without type 2 diabetes (all but one p<0.005). In addition, for the domains of CLDQ-NASH, the highest correlated domains of SF-36 were as follows: Physical Functioning for Activity (rho=0.70), Mental Health for Emotional (rho=0.72), Vitality for Fatigue (rho=0.75), Bodily Pain for Systemic (rho=0.72) (all p-values<0.0001). In contrast, domains of Abdominal and Worry which are more disease-specific did not show high correlations with domains in SF-36 (all rho≤0.50). In addition, the domains of CLDQ-NASH moderately correlated with work productivity and activity impairment returned by WPAI: rho from -0.39 to -0.53.

Discussion: This extensive validation of CLDQ-NASH demonstrates excellent psychometric characteristics. CLDQ-NASH performed well in this extensive round of validation in a larg of patients with biopsy-proven NASH. CLDQ-NASH is an important instrument to assess PROs in patients with NASH.


Disclosures:
Zobair Younossi: Allergan – Consultant. BMS – Consultant. Gilead Sciences – Consultant, Grant/Research Support. Intercept – Consultant, Grant/Research Support. Novartis – Consultant. NovoNordisk – Consultant. Sionogi – Consultant.
Maria Stepanova indicated no relevant financial relationships.
Issah Younossi indicated no relevant financial relationships.
Andrei Racila indicated no relevant financial relationships.

Zobair M. Younossi

Chairman, Department of Medicine, Inova Fairfax Medical Campus; Professor of Medicine, Virginia Commonwealth University, Inova Campus; Affiliate Professor of Biomedical Sciences, George Mason University
Fairfax, DC, US

Zobair M. Younossi, MD, MPH, is the Chairman of the Department, Inova Fairfax Medical Campus and He is also Professor of Medicine, Virginia Commonwealth University, Inova Campus and Affiliate Professor of Biomedical Sciences at George Mason University. Dr. Younossi earned his medical degree from the University of Rochester School of Medicine and Dentistry in Rochester, New York (Alpha Omega Alpha, 1989), and completed his residency in internal medicine as well as a fellowship in gastroenterology and hepatology at Scripps Clinic and Research Foundation in La Jolla, California. During his residency and fellowship, he earned his master of public health degree from San Diego State University (SDSU) School of Public Health in San Diego, California, being awarded the Hanlon Award and Outstanding Student Award for SDSU. He then served as the Staff Hepatologist and Senior Researcher at the Cleveland Clinic Foundation, Cleveland, Ohio (1995-2000). Dr. Younossi specializes in hepatology and gastroenterology and has authored over 400 articles and 12 book chapters in his field. He has also presented over 600 abstracts at international meetings and over 300 faculty lectures. Dr. Younossi's experience in scientific publishing includes being associate editor for Evidence Based Gastroenterology, former associate editor of Liver International, and editorial board member and journal reviewer for Hepatology. He also worked with many other journals in the areas of hepatology, gastroenterology, internal medicine, and with prominent publications such as The American Journal of Medicine and Journal of American Medical Association.

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55 - Extensive Validation of a Disease-Specific Health Related Quality of Life Instrument in Patients With Biopsy-Proven Non-Alcoholic Steatohepatitis (NASH): Chronic Liver Disease Questionnaire-NASH (CLDQ-NASH)



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