Liver Disease Specific PRO Questionnaires: Chronic Liver Disease Questionnaire

LPRO has developed and maintains Chronic Liver Disease Questionnaire (CLDQ) and its subtypes. Using standard validation process, CLDQ and its versions for hepatitis B (CLDQ-HBV), hepatitis C (CLDQ-HCV), non-alcoholic steatohepatitis (CLDQ-NASH) and Primary Sclerosing Cholangitis (CLD-PSC) have been developed and fully published. (Link to CORLD). These instruments are being used in a large number of clinical trials and research projects around the world.

The following paragraphs provide specific details about chronic liver disease questionnaire (CLDQ) and its subtypes:

1. CLDQ

Is the first fully validated disease specific health-related quality of life instrument for patients with liver disease. The instrument has six domains: Abdominal Symptoms, Activity/Energy, Emotional, Fatigue, Worry, and Systemic Symptoms (all range 1-7), and a total score which is an average of the domain scores. CLDQ is fully validated and translated in a a number of languages. CLDQ is used for all types liver diseases, specifically for clinical trials of HBV, alcoholic liver disease, cholestatic liver disease, cirrhosis and its complications such as hepatic encephalopathy and ascites.

2. CLDQ HCV

The Chronic Liver Disease Questionnaire-HCV Version (CLDQ-HCV) is the first HCV-specific HRQL assessment instrument which includes activity/energy, emotional, worry and systemic HRQL domains. All these domains range from 1 to 7 and are averaged up to the total CLDQ-HCV score. CLDQ-HCV was fully validated and translated into dozen languages. It has been extensively used in clinical trials of HCV with over 10,000 patients globally enrolled.

3. CLDQ NASH

Instrument includes 36 items grouped into 6 domains: Abdominal Symptoms, Activity/Energy, Emotional Health, Fatigue, Systemic Symptoms, and Worry. In CLDQ-NASH, patients are asked about how frequently they experience certain problems impairing various aspects of their well-being; a 1-7 Likert scale is used for the responses (the score of 1 would correspond to a problem is experienced “All of the time”, and the score of 7 to “None of the time”). The final scoring scheme suggests that the scores are calculated separately for each domain as an average of the domain’s items. In all domains, greater scores reflect better health, and the average of the domain scores yields the total CLDQ-NASH score.

4. CLDQ HBV

Instrument includes 19 items grouped into 5 domains: Emotional Health, Fatigue, Sleep, Systemic Symptoms, and Worry. In CLDQ-HBV, patients are asked about how frequently they experience certain problems impairing various aspects of their well-being; a 1-7 Likert scale is used for the responses (the score of 1 would correspond to a problem is experienced “All of the time”, and the score of 7 to “None of the time”). The final scoring scheme suggests that the scores are calculated separately for each domain as an average of the domain’s items. In all domains, greater scores reflect better health, and the average of the domain scores yields the total CLDQ-HBV score.

5. CLDQ PSC

Instrument includes 24 items grouped into 5 domains: Emotional Health, Fatigue, Sleep, Systemic Symptoms, and Worry. In CLDQ-PSC, patients are asked about how frequently they experience certain problems impairing various aspects of their well-being; a 1-7 Likert scale is used for the responses (the score of 1 would correspond to a problem is experienced “All of the time”, and the score of 7 to “None of the time”). The final scoring scheme suggests that the scores are calculated separately for each domain as an average of the domain’s items. In all domains, greater scores reflect better health, and the average of the domain scores yields the total CLDQ-PSC score.

6. CLDQ PBC

Instrument includes 35 items grouped into 7 domains: Diet, Emotion, Fatigue, Itch, Symptoms, Sleep, and Worry. In CLDQ-PBC, patients are asked about how frequently they experience certain problems impairing various aspects of their well-being; a 1-7 Likert scale is used for the responses (the score of 1 would correspond to a problem is experienced “All of the time”, and the score of 7 to “None of the time”). The final scoring scheme suggests that the scores are calculated separately for each domain as an average of the domain’s items. In all domains, greater scores reflect better health, and the average of the domain scores yields the total CLDQ-PBC score.