L-PRO LLC has developed and maintains the Chronic Liver Disease Questionnaire (CLDQ) and its disease-specific versions. Using standard instrument-development and validation processes, the CLDQ and its disease-specific versions for hepatitis B (CLDQ-HBV), hepatitis C (CLDQ-HCV), metabolic dysfunction-associated steatotic liver disease (CLDQ-MASLD, previously known as CLDQ-NAFLD/CLDQ-NASH), metabolic dysfunction-associated steatohepatitis (CLDQ-MASH), the CLDQ-MASH Symptom Questionnaire (CLDQ-MASH-SQ), primary biliary cholangitis (CLDQ-PBC), primary sclerosing cholangitis (CLDQ-PSC), and alcohol-associated liver disease (CLDQ-ALD) have been developed, validated, and published.
These validated patient-reported outcome instruments are currently being used in numerous clinical trials and research projects worldwide. Although there is some overlap among the instruments in items that capture aspects of HRQL common to chronic liver disease, each disease-specific version also includes items and domains designed to capture the unique impact of the specific liver disease on patients’ health and well-being.
Copies of the instruments and their scoring algorithms can be obtained through the link below following execution of an appropriate licensing agreement.
For additional information about obtaining permission to use the CLDQ or any of its disease-specific versions, please contact the Licensing Manager or the CLDQ administrative office using the email addresses provided above under “Contact Us.”
The following paragraphs provide specific details about chronic liver disease questionnaire (CLDQ) and its subtypes:
1. CLDQ CLDQ is the first fully validated disease-specific health-related quality of life (HRQL) instrument for patients with chronic liver disease and is one of the most robust and extensively used HRQL instruments in the field of chronic disease. It is designed to capture the impact of liver disease on patients across the spectrum of disease severity, from early-stage to advanced liver disease. CLDQ is particularly appropriate when different etiologies of liver disease are being compared or when an etiology-specific CLDQ instrument is not available.
The instrument includes 29 items grouped into 6 domains: Abdominal Symptoms, Activity/Energy, Emotional Health, Fatigue, Systemic Symptoms, and Worry. A 1–7 Likert scale is used for responses, with higher scores reflecting better health and HRQL. Scores are calculated separately for each domain, and the average of the 6 domain scores yields the total CLDQ score.
CLDQ has been fully validated and translated into numerous languages and has been extensively used in clinical research and clinical trials across a broad range of liver diseases, including viral hepatitis, alcohol-associated liver disease, cholestatic liver diseases, cirrhosis, and complications of advanced liver disease such as hepatic encephalopathy and ascites. When an etiology-specific instrument—such as CLDQ-MASH, CLDQ-MASLD, CLDQ-MASH SQ, CLDQ-PBC, CLDQ-PSC, CLDQ-HBV, CLDQ-HCV, or CLDQ-ALD—is available and appropriate for the study population, that instrument may provide a more disease-specific assessment of HRQL.
CLDQ is the first fully validated disease-specific health-related quality of life (HRQL) instrument for patients with chronic liver disease and is one of the most robust and extensively used HRQL instruments in the field of chronic disease. It is designed to capture the impact of liver disease on patients across the spectrum of disease severity, from early-stage to advanced liver disease. CLDQ is particularly appropriate when different etiologies of liver disease are being compared or when an etiology-specific CLDQ instrument is not available.
The instrument includes 29 items grouped into 6 domains: Abdominal Symptoms, Activity/Energy, Emotional Health, Fatigue, Systemic Symptoms, and Worry. A 1–7 Likert scale is used for responses, with higher scores reflecting better health and HRQL. Scores are calculated separately for each domain, and the average of the 6 domain scores yields the total CLDQ score.
CLDQ has been fully validated and translated into numerous languages and has been extensively used in clinical research and clinical trials across a broad range of liver diseases, including viral hepatitis, alcohol-associated liver disease, cholestatic liver diseases, cirrhosis, and complications of advanced liver disease such as hepatic encephalopathy and ascites. When an etiology-specific instrument—such as CLDQ-MASH, CLDQ-MASLD, CLDQ-MASH SQ, CLDQ-PBC, CLDQ-PSC, CLDQ-HBV, CLDQ-HCV, or CLDQ-ALD—is available and appropriate for the study population, that instrument may provide a more disease-specific assessment of HRQL.
2. CLDQ-MASLD (formally known as CLDQ-NAFLD or CLDQ-NASH) CLDQ-MASLD can be used to assess health-related quality of life (HRQL) in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). The instrument was initially developed and validated for patients with nonalcoholic fatty liver disease (NAFLD), including NASH, and was subsequently revalidated following the introduction of the new definition and diagnostic criteria for MASLD. The instrument includes 36 items grouped into 6 domains: Abdominal Symptoms, Activity/Energy, Emotional Health, Fatigue, Systemic Symptoms, and Worry. In CLDQ-MASLD, patients are asked how frequently they experience certain problems that affect various aspects of their well-being. A 1–7 Likert scale is used for responses, with a score of 1 corresponding to experiencing a problem “All of the time” and a score of 7 corresponding to “None of the time.” Scores are calculated separately for each domain as the average of the items within that domain. In all domains, higher scores reflect better health and HRQL, and the average of the domain scores yields the total CLDQ-MASLD score.
CLDQ-MASLD can be used to assess health-related quality of life (HRQL) in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). The instrument was initially developed and validated for patients with nonalcoholic fatty liver disease (NAFLD), including NASH, and was subsequently revalidated following the introduction of the new definition and diagnostic criteria for MASLD. The instrument includes 36 items grouped into 6 domains: Abdominal Symptoms, Activity/Energy, Emotional Health, Fatigue, Systemic Symptoms, and Worry. In CLDQ-MASLD, patients are asked how frequently they experience certain problems that affect various aspects of their well-being. A 1–7 Likert scale is used for responses, with a score of 1 corresponding to experiencing a problem “All of the time” and a score of 7 corresponding to “None of the time.” Scores are calculated separately for each domain as the average of the items within that domain. In all domains, higher scores reflect better health and HRQL, and the average of the domain scores yields the total CLDQ-MASLD score.
3. CLDQ-MASH CLDQ-MASH is a newly developed and validated instrument which includes 35 items grouped into 7 domains: Activity, Digestive Symptoms and Diet, Emotional Well-being, Fatigue, Sleep Disturbances, Systemic Symptoms, and Worry. In CLDQ-MASH, patients are asked how frequently during the past 2 weeks they experienced or were bothered by specific problems affecting various aspects of their health and well-being. A 1–7 Likert scale is used for the responses (the score of 1 corresponds to experiencing a problem “All of the time,” and the score of 7 to “None of the time”). The final scoring scheme suggests that scores are calculated separately for each domain as an average of the domain’s items, without additional transformation or weighting. In all domains, greater scores reflect better health, and the average of the 7 domain scores yields the total CLDQ-MASH score.
CLDQ-MASH is a newly developed and validated instrument which includes 35 items grouped into 7 domains: Activity, Digestive Symptoms and Diet, Emotional Well-being, Fatigue, Sleep Disturbances, Systemic Symptoms, and Worry. In CLDQ-MASH, patients are asked how frequently during the past 2 weeks they experienced or were bothered by specific problems affecting various aspects of their health and well-being. A 1–7 Likert scale is used for the responses (the score of 1 corresponds to experiencing a problem “All of the time,” and the score of 7 to “None of the time”). The final scoring scheme suggests that scores are calculated separately for each domain as an average of the domain’s items, without additional transformation or weighting. In all domains, greater scores reflect better health, and the average of the 7 domain scores yields the total CLDQ-MASH score.
4. CLDQ-MASH Symptom Questionnaire (CLDQ-MASH-SQ) CLDQ-MASH SQ is the only MASH specific instrument that captures symptoms. The instrument includes 36 items grouped into 8 symptom domains: Abdominal Symptoms, Cognitive Symptoms, Health Distress, Fatigue Symptoms, Mental Symptoms, Peripheral Symptoms, Sleep-related Symptoms, and Systemic Symptoms. The CLDQ-MASH-SQ is designed specifically to assess symptom burden in patients with MASH. All items are scored on a standardized 1–7 scale and coded in the same direction. The final scoring scheme suggests that scores are calculated separately for each domain as the unweighted arithmetic mean of the domain’s items. In all domains, greater scores indicate lower symptom burden and better health.
CLDQ-MASH SQ is the only MASH specific instrument that captures symptoms. The instrument includes 36 items grouped into 8 symptom domains: Abdominal Symptoms, Cognitive Symptoms, Health Distress, Fatigue Symptoms, Mental Symptoms, Peripheral Symptoms, Sleep-related Symptoms, and Systemic Symptoms. The CLDQ-MASH-SQ is designed specifically to assess symptom burden in patients with MASH. All items are scored on a standardized 1–7 scale and coded in the same direction. The final scoring scheme suggests that scores are calculated separately for each domain as the unweighted arithmetic mean of the domain’s items. In all domains, greater scores indicate lower symptom burden and better health.
5. CLDQ-ALD CLDQ-ALD is developed for patients with spectrum of ALD. The instrument includes 40 items grouped into 9 domains: Abdominal Symptoms, Alcohol Use Disorder, Emotional Well-being, Functional Well-being, Fatigue, Itch, Physical Well-being, Sleep Disturbance, and Worry. In CLDQ-ALD, patients are asked how frequently during the past 2 weeks they experienced or were bothered by specific problems affecting various aspects of their health and well-being. A 1–7 Likert scale is used for the responses (the score of 1 corresponds to experiencing a problem “All of the time,” and the score of 7 to “None of the time”). The final scoring scheme suggests that scores are calculated separately for each domain as an average of the domain’s items, without item weighting or additional Likert-score transformations. In all domains, greater scores reflect better health and HRQL, and the average of the 9 domain scores yields the total CLDQ-ALD score.
CLDQ-ALD is developed for patients with spectrum of ALD. The instrument includes 40 items grouped into 9 domains: Abdominal Symptoms, Alcohol Use Disorder, Emotional Well-being, Functional Well-being, Fatigue, Itch, Physical Well-being, Sleep Disturbance, and Worry. In CLDQ-ALD, patients are asked how frequently during the past 2 weeks they experienced or were bothered by specific problems affecting various aspects of their health and well-being. A 1–7 Likert scale is used for the responses (the score of 1 corresponds to experiencing a problem “All of the time,” and the score of 7 to “None of the time”). The final scoring scheme suggests that scores are calculated separately for each domain as an average of the domain’s items, without item weighting or additional Likert-score transformations. In all domains, greater scores reflect better health and HRQL, and the average of the 9 domain scores yields the total CLDQ-ALD score.
6. CLDQ-PBC CLDQ-PBC can be used to assess health-related quality of life (HRQL) in patients with primary biliary cholangitis (PBC). The instrument includes 35 items grouped into 7 domains: Diet, Emotion, Fatigue, Itch, Symptoms, Sleep, and Worry. In CLDQ-PBC, patients are asked how frequently they experience certain problems that affect various aspects of their well-being. A 1–7 Likert scale is used for responses, with a score of 1 corresponding to experiencing a problem “All of the time” and a score of 7 corresponding to “None of the time.” Scores are calculated separately for each domain as the average of the items within that domain. In all domains, higher scores reflect better health and HRQL, and the average of the domain scores yields the total CLDQ-PBC score.
CLDQ-PBC can be used to assess health-related quality of life (HRQL) in patients with primary biliary cholangitis (PBC). The instrument includes 35 items grouped into 7 domains: Diet, Emotion, Fatigue, Itch, Symptoms, Sleep, and Worry. In CLDQ-PBC, patients are asked how frequently they experience certain problems that affect various aspects of their well-being. A 1–7 Likert scale is used for responses, with a score of 1 corresponding to experiencing a problem “All of the time” and a score of 7 corresponding to “None of the time.” Scores are calculated separately for each domain as the average of the items within that domain. In all domains, higher scores reflect better health and HRQL, and the average of the domain scores yields the total CLDQ-PBC score.
7. CLDQ-PSC CLDQ-PSC can be used to assess health-related quality of life (HRQL) in patients with primary sclerosing cholangitis (PSC). The instrument includes 24 items grouped into 5 domains: Emotional Health, Fatigue, Sleep, Systemic Symptoms, and Worry. In CLDQ-PSC, patients are asked how frequently they experience certain problems that affect various aspects of their well-being. A 1–7 Likert scale is used for responses, with a score of 1 corresponding to experiencing a problem “All of the time” and a score of 7 corresponding to “None of the time.” Scores are calculated separately for each domain as the average of the items within that domain. In all domains, higher scores reflect better health and HRQL, and the average of the domain scores yields the total CLDQ-PSC score.
CLDQ-PSC can be used to assess health-related quality of life (HRQL) in patients with primary sclerosing cholangitis (PSC). The instrument includes 24 items grouped into 5 domains: Emotional Health, Fatigue, Sleep, Systemic Symptoms, and Worry. In CLDQ-PSC, patients are asked how frequently they experience certain problems that affect various aspects of their well-being. A 1–7 Likert scale is used for responses, with a score of 1 corresponding to experiencing a problem “All of the time” and a score of 7 corresponding to “None of the time.” Scores are calculated separately for each domain as the average of the items within that domain. In all domains, higher scores reflect better health and HRQL, and the average of the domain scores yields the total CLDQ-PSC score.
8. CLDQ-HBV CLDQ-HBV can be used to assess health-related quality of life (HRQL) in patients with hepatitis B virus (HBV) or hepatitis delta virus (HDV) infection. The instrument includes 19 items grouped into 5 domains: Emotional Health, Fatigue, Sleep, Systemic Symptoms, and Worry. In CLDQ-HBV, patients are asked how frequently they experience certain problems that affect various aspects of their well-being. A 1–7 Likert scale is used for responses, with a score of 1 corresponding to experiencing a problem “All of the time” and a score of 7 corresponding to “None of the time.” Scores are calculated separately for each domain as the average of the items within that domain. In all domains, higher scores reflect better health and HRQL, and the average of the domain scores yields the total CLDQ-HBV score.
CLDQ-HBV can be used to assess health-related quality of life (HRQL) in patients with hepatitis B virus (HBV) or hepatitis delta virus (HDV) infection. The instrument includes 19 items grouped into 5 domains: Emotional Health, Fatigue, Sleep, Systemic Symptoms, and Worry. In CLDQ-HBV, patients are asked how frequently they experience certain problems that affect various aspects of their well-being. A 1–7 Likert scale is used for responses, with a score of 1 corresponding to experiencing a problem “All of the time” and a score of 7 corresponding to “None of the time.” Scores are calculated separately for each domain as the average of the items within that domain. In all domains, higher scores reflect better health and HRQL, and the average of the domain scores yields the total CLDQ-HBV score.
9. CLDQ HCV CLDQ-HCV can be used to assess health-related quality of life (HRQL) in patients with hepatitis C virus (HCV) infection. The instrument includes items grouped into 4 domains: Activity/Energy, Emotional Health, Systemic Symptoms, and Worry. In CLDQ-HCV, patients are asked about problems affecting various aspects of their well-being. A 1–7 scale is used for responses. Scores are calculated separately for each domain, and higher scores reflect better health and HRQL. The average of the domain scores yields the total CLDQ-HCV score. CLDQ-HCV has been fully validated, translated into multiple languages, and extensively used in HCV clinical trials involving more than 10,000 patients worldwide.
CLDQ-HCV can be used to assess health-related quality of life (HRQL) in patients with hepatitis C virus (HCV) infection. The instrument includes items grouped into 4 domains: Activity/Energy, Emotional Health, Systemic Symptoms, and Worry. In CLDQ-HCV, patients are asked about problems affecting various aspects of their well-being. A 1–7 scale is used for responses. Scores are calculated separately for each domain, and higher scores reflect better health and HRQL. The average of the domain scores yields the total CLDQ-HCV score. CLDQ-HCV has been fully validated, translated into multiple languages, and extensively used in HCV clinical trials involving more than 10,000 patients worldwide.