Patient‐reported outcomes in patients with non‐alcoholic fatty liver disease: A narrative review of Chronic Liver Disease Questionnaire‐non‐alcoholic fatty liver disease/non‐alcoholic steatohepatitis

Abstract

Non‐alcoholic fatty liver disease (NAFLD) is the most common liver disease worldwide and one of the leading causes of hepatocellular carcinoma and liver transplantation. Moreover, patients with NAFLD frequently complain of non‐specific symptoms including fatigue, abdominal discomfort, as well as anxiety, and NAFLD is reported to affect patient‐reported outcomes (PROs). Thus, for clarifying the total burden of NAFLD, it is crucial to assess all associated outcomes, including not only clinical and economic outcomes but also PROs. PROs are thought to reflect what is happening in one's daily life and is an important way patients and health‐care professionals communicate. There are various instruments for the assessment of PROs. Recently, a NAFLD/non‐alcoholic steatohepatitis (NASH)‐specific instrument called “Chronic Liver Disease Questionnaire (CLDQ)‐NAFLD/NASH” has been developed. CLDQ‐NAFLD/NASH comprises six domains: (i) abdominal symptoms, (ii) activity/energy, (iii) emotional health, (iv) fatigue, (v) systemic symptoms, and (vi) worry. CLDQ‐NAFLD/NASH has demonstrated excellent internal consistency, face validity, content validity, and test–retest reliability. It has been sufficiently validated in two international phase 3 clinical trials. In this review, we summarize features of various instruments for assessing PROs by focusing on CLDQ‐NAFLD/NASH. We also examine the validity of CLDQ‐NAFLD/NASH in Japanese patients and alterations in CLDQ‐NAFLD/NASH score in Japanese patients with significant hepatic fibrosis. Moreover, we discuss the utility of CLDQ‐NAFLD/NASH in phase 3 clinical trials and in a real‐world clinical setting.

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“…The deterioration of NAFLD can lead to cirrhosis and liver cancer. Changes in people’s lifestyles and dietary modes as a result of industrialization development, NAFLD has become the most common liver disease, the proportion of people who suffered from NAFLD worldwide which was rising all the time was between 20 and 30%, and 10–20% of them will develop into NASH ( Yamamura et al, 2021 ).…”

First‐line sorafenib sequential therapy and liver disease etiology for unresectable hepatocellular carcinoma using inverse probability weighting: A multicenter retrospective study

“…NAFLD is possibly predicted to be one of the most causes of HCC in the coming decades. [29][30][31] NASH is characterized by severe hepatocyte injury and is an inflammatory consequence of NAFLD. This condition is strongly associated with metabolic syndrome.…”

Association between Activity and Brain-Derived Neurotrophic Factor in Patients with Non-Alcoholic Fatty Liver Disease: A Data-Mining Analysis

“…The CLDQ-NAFLD/NASH is a disease-specific questionnaire that consists of 36 items grouped into 6 domains: fatigue, systemic symptoms, emotional health, worry, abdominal symptoms, and activity [ 8 , 10 , 11 ]. All participants were asked to complete the Japanese version of the CLDQ-NAFLD, which has previously been validated in Japan [ 9 ]. The questions were closed-ended, and the answers were provided using a Likert scale ranging from 1 (all the time) to 7 (none of the time), representing the frequency of clinical symptoms and emotional problems.…”

“…Various methods are used to assess activity. The recently developed Chronic Liver Disease Questionnaire (CLDQ)-NAFLD/non-alcoholic steatohepatitis (NASH) is a useful, disease-specific, patient-reported outcome measure for patients with NAFLD [ 8 , 9 ]. In this context, the CLDQ-NAFLD/NASH has been sufficiently validated and widely used in international clinical trials [ 10 , 11 ].…”