In the Journals

Experts validate NASH-specific health-related quality of life tool

Zobair M. Younossi, MD
Zobair M. Younossi

Researchers validated the disease-specific Chronic Liver Disease Questionnaire for nonalcoholic steatohepatitis, also known as CLDQ-NASH, as a useful health-related quality of life instrument for patients with NASH.

“The instrument can be used in clinical trials or clinical research involving these patients,” Zobair M. Younossi, MD, chairman of the department of medicine at Inova Fairfax Hospital in Virginia, and colleagues wrote. “As we understand the global importance of NASH and develop new diagnostic modalities and treatment regimens, inclusion of patient-reported outcomes such as those captured by CLDQ-NASH will be increasingly important.”

The instrument’s initial items derived from patient interviews and focus groups, published literature, and expert input. The final product included 36 items grouped into six domains based on the structure of the original CLDQ instrument: abdominal symptoms, activity/energy, emotional health, fatigue, systemic symptoms, and worry.

The validation study comprised 1,667 patients who completed the CLDQ-NASH as well as the 36-Item Short Form Health Survey (SF-36), including 870 patients with cirrhosis.

Results showed good to excellent internal consistency in all domains with Cronbach’s alpha values ranging from 0.8 to 0.94. Additionally, changes in Cronbach’s alpha values after one-item exclusions did not exceed 0.096 in any domain. This suggests that “the items from the same domains were neither too correlated with, nor too different from each other,” according to the researchers.

Men and patients with psychiatric disorders such as depression or anxiety had higher scores in all domains compared with the rest of the cohort (P < .0001). Patients with comorbid obesity or diabetes type 2 had significantly impaired patient-reported outcomes in most domains (P < .01). Patients with cirrhosis had significantly lower scores in all domains except “systemic symptoms” compared with patients with bridging fibrosis and those without cirrhosis (P < .015).

Finally, the researchers report that the “abdominal symptoms” and “worry” domains of the CLDQ-NASH did not correlate significantly with any domains of SF-36, therefore “reflecting the disease-specific nature of these two domains,” they wrote.

“It is important to note that 29 out of 36 items of CLDQ-NASH are shared with the original CLDQ which has been extensively validated in patients with NASH; that further strengthens psychometric validity of the derivative NASH-specific instrument which was used in this study,” Younossi and colleagues wrote. “However, the additional items included in CLDQ-NASH allow for more NASH-specific assessment which will likely add to its reliability.” – by Talitha Bennett

Disclosure: Younossi is a consultant to or received research funds from AbbVie, Bristol-Myers Squib, Gilead, GlaxoSmithKline, Intercept, Novo Nordisk and Shionogi. Please see the full study for the other authors’ relevant financial disclosures.

Zobair M. Younossi, MD
Zobair M. Younossi

Researchers validated the disease-specific Chronic Liver Disease Questionnaire for nonalcoholic steatohepatitis, also known as CLDQ-NASH, as a useful health-related quality of life instrument for patients with NASH.

“The instrument can be used in clinical trials or clinical research involving these patients,” Zobair M. Younossi, MD, chairman of the department of medicine at Inova Fairfax Hospital in Virginia, and colleagues wrote. “As we understand the global importance of NASH and develop new diagnostic modalities and treatment regimens, inclusion of patient-reported outcomes such as those captured by CLDQ-NASH will be increasingly important.”

The instrument’s initial items derived from patient interviews and focus groups, published literature, and expert input. The final product included 36 items grouped into six domains based on the structure of the original CLDQ instrument: abdominal symptoms, activity/energy, emotional health, fatigue, systemic symptoms, and worry.

The validation study comprised 1,667 patients who completed the CLDQ-NASH as well as the 36-Item Short Form Health Survey (SF-36), including 870 patients with cirrhosis.

Results showed good to excellent internal consistency in all domains with Cronbach’s alpha values ranging from 0.8 to 0.94. Additionally, changes in Cronbach’s alpha values after one-item exclusions did not exceed 0.096 in any domain. This suggests that “the items from the same domains were neither too correlated with, nor too different from each other,” according to the researchers.

Men and patients with psychiatric disorders such as depression or anxiety had higher scores in all domains compared with the rest of the cohort (P < .0001). Patients with comorbid obesity or diabetes type 2 had significantly impaired patient-reported outcomes in most domains (P < .01). Patients with cirrhosis had significantly lower scores in all domains except “systemic symptoms” compared with patients with bridging fibrosis and those without cirrhosis (P < .015).

Finally, the researchers report that the “abdominal symptoms” and “worry” domains of the CLDQ-NASH did not correlate significantly with any domains of SF-36, therefore “reflecting the disease-specific nature of these two domains,” they wrote.

“It is important to note that 29 out of 36 items of CLDQ-NASH are shared with the original CLDQ which has been extensively validated in patients with NASH; that further strengthens psychometric validity of the derivative NASH-specific instrument which was used in this study,” Younossi and colleagues wrote. “However, the additional items included in CLDQ-NASH allow for more NASH-specific assessment which will likely add to its reliability.” – by Talitha Bennett

Disclosure: Younossi is a consultant to or received research funds from AbbVie, Bristol-Myers Squib, Gilead, GlaxoSmithKline, Intercept, Novo Nordisk and Shionogi. Please see the full study for the other authors’ relevant financial disclosures.