Pilot Multi-centre Study Of Quality Of Life In Patients With AIH
Research type
Research Study
Full title
PILOT MULTICENTRE STUDY OF QUALITY OF LIFE IN PATIENTS WITH AIH AND ASSESSMENT OF PATIENTS’ VIEWS OF THREE GENERIC PATIENT-RELATED OUTCOME MEASURES (PROMS)
IRAS ID
270937
Contact name
Dermot Gleeson
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS FT
Duration of Study in the UK
1 years, 4 months, 15 days
Research summary
Autoimmune Hepatitis is a chronic non-infectious immune-mediated liver disease, affecting mainly females, and people of all ages and races. Unlike some liver diseases, Autoimmune Hepatitis is unrelated to lifestyle. The commonest presenting symptoms are jaundice, fatigue, nausea and joint pains. Untreated, Autoimmune Hepatitis is an aggressive disease, resulting in liver failure and death in most patients within 5 years.
Evaluation of treatments for Autoimmune Hepatitis has focussed mainly on objective measures of disease activity and severity and has not taken proper account of how patients feel. We hope to address this by developing a patient reported outcome measure specifically for these patients, evaluating both the impact of the disease and its treatment. Such a measure would facilitate trials of newer, potentially better treatments, and would ultimately improve the lives of patients with Autoimmune Hepatitis. We propose here a complementary and more broadly-based prospective study of quality of life in patients Autoimmune Hepatitis. This is a pilot study of prevalent patients with Autoimmune Hepatitis which will recruit participants from outpatient clinics across the UK. Participants will complete 3 validated patient reported outcome measures for this study and also a non-validated tool which will explore the patients’ view of the validated tools. Further data will be collected by the clinical teams relating to the patients’ medical history. As this is a pilot study there will be no formal sample size, instead the questionnaires will be disseminated to as many patients as possible. Each centre involved see approximately 200 patients with autoimmune hepatitis each year, we hope to capture as much data as possible from this prevalent cohort.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
19/EM/0285
Date of REC Opinion
18 Sep 2019
REC opinion
Favourable Opinion