Impact of steroid-based treatment on symptoms and well-being in AIH
Research type
Research Study
Full title
PROSPECTIVE PILOT STUDY OF THE IMPACT OF STANDARD STEROID-BASED TREATMENT ON PATIENT SYMPTOMS AND ON WELL-BEING IN AUTOIMMUNE HEPATITIS
IRAS ID
254398
Contact name
Dermot Gleeson
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS FT
Duration of Study in the UK
2 years, 0 months, 1 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.
Corticosteroid-based treatment of patients with Autoimmune Hepatitis was shown, almost 50 years ago to improve dramatically the short and medium term outcome and remains standard treatment for most patients. However treatment of Autoimmune Hepatitis remains suboptimal.
The perspectives of patients themselves in regard to Autoimmune Hepatitis and to its treatment have been little studied. There are only few reports of Patient-Reported Outcome measures. These are “one off” observational studies in already-treated patients. Studies to date do however suggest impaired Quality of Life in patients with Autoimmune Hepatitis. The case for developing novel treatments for Autoimmune Hepatitis would be better informed by more detailed prospective studies of the impact of steroid-based treatment of Autoimmune Hepatitis on patient symptoms and on quality of life. We propose here a complementary and more broadly-based prospective study of quality of life in patients Autoimmune Hepatitis attending in five Yorkshire-based Liver Units:
(a) including all patients commencing (or re-commencing) treatment for suspected Autoimmune Hepatitis (initial presentation or relapse). This would also include patients not undergoing liver biopsy but who met the (less restrictive) 1999 criteria (21)
(b) also including patients who are discontinuing steroid therapy
(c) incorporating a questionnaire directly focusing on steroid-related side effects
The overall aim will be to assess prospectively, symptoms and changes in well-being, using validated Patient-Reported Outcome Measures in patients with Autoimmune Hepatitis who are starting standard treatment and in those stopping steroid treatment.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
19/WM/0025
Date of REC Opinion
22 Jan 2019
REC opinion
Favourable Opinion