# Exploring the patient experience of chronic hepatitis D (CHD) and assessment of content validity of the Hepatitis Quality of Life Questionnaire and (HQLQv2) and the Fatigue Severity Scale (FSS)

## TL;DR

This study explores how chronic hepatitis D affects patients' lives and checks if two questionnaires are valid for measuring quality of life and fatigue in these patients.

## Contribution

The study provides new insights into the patient experience of CHD and validates the use of HQLQv2 and FSS in HDV populations.

## Key findings

- Fatigue was the most commonly reported and burdensome symptom among CHD patients.
- Patients confirmed that the HQLQv2 and FSS questionnaires are relevant and understandable for assessing their condition.
- CHD impacts emotional, physical, and social aspects of patients' lives, including mood, mobility, and work.

## Abstract

Chronic hepatitis D (CHD) is the most severe form of viral hepatitis, which results in accelerated progression to cirrhosis and poor prognosis compared with other hepatitis infections, impacting patients’ health-related quality of life (HRQoL). To adequately capture patient perspectives of new hepatitis D virus (HDV) treatments in clinical trials, patient-reported outcome (PRO) measures that are valid and assess key concepts relevant to the patient are needed. This study aimed to explore the patient experience of CHD and evaluate the content validity of the Hepatitis Quality of Life Questionnaire (HQLQv2) and the Fatigue Severity Scale (FSS) for use in an HDV population.

Combined qualitative concept elicitation (CE) and cognitive debriefing (CD) interviews were conducted with 39 patients in Germany, Italy, Spain, and the US with a clinician-confirmed diagnosis of CHD. Participants described their experience of CHD, informing the development of a conceptual model, and then completed the HQLQv2 and FSS using a think-aloud technique to assess understanding, relevance, and comprehensiveness of items, instructions, response scales, and recall periods. Interviews were conducted in the principal language of each country; official translations of the instruments were used, and all patient-facing study documents and the interview guide were translated by certified translators.

The sample included participants with a range of liver fibrosis stages, including 11 with compensated (n = 9) and decompensated (n = 2) cirrhosis. Fatigue, loss of appetite, nausea, joint pain, and pain over the liver were the most frequently reported signs/symptoms. Fatigue was most commonly mentioned and was described as a severe and particularly burdensome symptom, that impacted several aspects of patients’ daily lives. Participants reported that CHD impacted their emotional wellbeing (low mood, anxiety), physical functioning (difficulty walking), social functioning (attending social events), activities of daily living (household chores), and work. Participants demonstrated a good understanding of the HQLQv2 and FSS items, instructions, response scales and recall periods, and the concepts assessed were considered relevant to CHD by most participants.

Findings contribute to the understanding of the patient experience of CHD and support content validity of the HQLQv2 and FSS as outcome assessments for use in an HDV population.

The online version contains supplementary material available at 10.1186/s41687-025-00903-3.