QoL in PSC
Research type
Research Study
Full title
Development of a quality of life questionnaire for people with primary sclerosing cholangitis (PSC)
IRAS ID
218355
Contact name
Misha Ladva
Contact email
Sponsor organisation
University College London
Duration of Study in the UK
1 years, 5 months, 22 days
Research summary
Primary sclerosing cholangitis (PSC) is a poorly understood disease of the bile ducts. People with PSC live knowing there is no curative treatment for their disorder, and symptoms can be severe and unpredictable, sometimes progressing rapidly to end stage liver disease. Between 10-15% of people with PSC with involvement of the large bile ducts may develop bile duct cancer, and more than three quarters also live with inflammatory bowel disease. More than half of people with PSC with symptomatic large duct disease progress to requiring a liver transplant, and disease can re-occur in 25% of people after transplant.
For people with PSC, living with fatigue, pain and itching is a daily reality. A recent survey conducted by ‘PSC Support’, a voluntary organisation providing information and support to people with PSC, showed that the majority of people with PSC (79%) had suffered from fatigue in the previous four weeks, with over half suffering with upper right quadrant pain (52%) and/or itching (52%), and 35% suffering with depression. This burden of symptoms leads to a significant impairment of quality of life for people with PSC.
The purpose of this study is to develop a provisional questionnaire to measure quality of life in people with PSC, ready for large scale field validation. The final questionnaire may benefit clinical practice by providing an important patient-reported outcome which reflects the actual experience of the condition. This could be used for assessing the benefit of therapeutic interventions, and may also help describe the impact of PSC over time and between different groups, leading to a better understanding of the disorder. The study will be conducted in two stages. Stage 1 will identify relevant issues for people living with PSC and develop a provisional questionnaire. Stage 2 will pre-test the provisional questionnaire with people living with PSC.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
17/LO/1108
Date of REC Opinion
8 Aug 2017
REC opinion
Further Information Favourable Opinion