OBJECTIVES: This study aimed to evaluate the content validity of the Chronic Liver Disease Questionnaire (CLDQ) and EQ-5D-5L in a chronic hepatitis B (CHB) patient population.

METHODS: Patients receiving treatment for CHB in the United Kingdom were asked to complete the measures using a ‘think aloud’ cognitive debriefing technique, sharing their thoughts on each question and response option. Framework analysis of interview transcripts using ATLAS.ti v7.5. explored conceptual relevance, understanding of item wording, and suitability of response scale/options and recall period. To identify missing concepts, CLDQ content was compared with a CHB conceptual model developed from qualitative literature and multinational concept elicitation interviews with 84 patients with CHB.

RESULTS: Twenty-three patients completed the CLDQ (74% male; aged 18-55; 39% Asian, 35% Black, 22% White, 4% other ethnicity). Patients generally found the CLDQ response options and recall period appropriate. Patients collectively endorsed each CLDQ item as relevant, with fatigue, pain, and emotional wellbeing (e.g., worry) the most common concerns. Some concepts (e.g., shortness of breath) were less common amongst the sample. Some terminology (e.g., ‘abdominal’) was difficult for patients to understand. Comparison with the CHB conceptual model highlighted that the CLDQ does not assess several important concepts for patients with CHB related to emotional and psychological wellbeing, lifestyle limitations, and impact on relationships. Patients understood the EQ-5D-5L but many did not find items assessing mobility and self-care relevant.

CONCLUSIONS: The CLDQ provides comprehensive assessment of fatigue and pain-related symptoms experienced by patients with CHB, and of some aspects of emotional wellbeing. The CLDQ does not assess stigmatization and impact on self-esteem which are important concepts for many patients with CHB. Revised wording is recommended to ensure the CLDQ is easy for CHB patients to understand. EQ-5D-5L items assessing self-care and mobility may be less relevant for CHB patients.