AIH quality of life and treatment experience
Research type
Research Study
Full title
Semi-structured qualitative interview study of quality of life in Autoimmune Hepatitis (AIH) and patients’ experiences of treatment\n\n
IRAS ID
265381
Contact name
Dermot Gleeson
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS FT
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Autoimmune Hepatitis is a chronic non-infectious liver disease, affecting mainly females (80%) and people of all ages and races. Untreated, Autoimmune Hepatitis is an aggressive disease, often resulting in cirrhosis, liver failure and death. Standard treatment of Autoimmune Hepatitis is not always effective. Data suggests 10-20% of patients fail to achieve disease remission and 10-40% patients develop progressive liver fibrosis. Consequently, survival of treated AIH is only 50-70% after 20-30 years. The perspectives of patients themselves in regard to Autoimmune Hepatitis and its treatment have to date been little studied, however the research available suggests impaired quality of life in this patient group. The aim of this study is to develop a disease-specific patient-reported outcome measure to assess Quality of Life in patients with Autoimmune Hepatitis. In order to achieve this we will conduct a series of recorded semi-structured interviews with a carefully chosen sample of patients with Autoimmune Hepatitis. These interviews would seek to explore patients’ subjective experiences of Autoimmune Hepatitis and its treatment. Analysis of the transcripts will identify any emerging quality of life themes to inform development of a Draft Questionnaire. In subsequent studies in a much larger patient cohort, we would refine and validate this questionnaire, and develop it into an Autoimmune Hepatitis -specific PROM. The study will be conducted at Sheffield Teaching Hospitals NHS FT and will recruit patients via the clinical database or through outpatient clinics at both Royal Hallamshire Hospital and Northern General Hospital. Interviews will be booked at a time convenient to patients.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
19/YH/0167
Date of REC Opinion
29 May 2019
REC opinion
Favourable Opinion