HepFree sub-study version 1
Research type
Research Database
IRAS ID
187017
Contact name
Victoria Appleby
Contact email
Research summary
HepFree observational sub-study: The impact of chronic hepatitis C on healthcare utilisation
REC name
London - West London & GTAC Research Ethics Committee
REC reference
16/LO/0079
Date of REC Opinion
27 Jan 2016
REC opinion
Favourable Opinion
Data collection arrangements
The research database will contain information on healthcare resource utilisation, including all attendances in primary care by immigrant populations who have been tested for viral hepatitis through the HepFree trial. The primary objective of the sub-study is to investigate whether individuals with chronic hepatitis C who have been identified and diagnosed through the HepFree trial(12/LO/1768) have made greater use of healthcare resources prior to diagnosis compared to individuals with a negative hepatitis screening test. Anonymised data will be collected from electronic patient records in primary care by the clinical fellow working on the sub-study. All trial data is collected using a unique study ID and the sole method for linking this to patient identifiable data including date of birth and NHS number is by using Systmone within the GP surgery. There is no way of identifying a participant using the study ID outside of the GP surgery. The unique study number from the main HepFree trial will be used when recording information in the research database. The research database is a password protected Microsoft database on a secure, NHS computer hard drive at Bradford Royal Infirmary (Bradford Teaching Hospitals NHS Foundation Trust, Duckworth Lane, Bradford, BD9 6RJ). Data will be maintained in accordance with information governance policies. Only the clinical fellow and chief investigator, who acts as the data custodian will have access to the database.
Research programme
This data will not be released to any other researchers or research organisations, it will act as a resource to members of the trial team only. The collection and storage of data will be done in accordance with local trust information governance policies. To my knowledge a research database of this type does not already exist. The database will build on existing data from the HepFree trial which has been collected on screening immigrant populations for viral hepatitis in order to give us a greater understanding of this cohort of subjects and their health needs. There has been previous research into populations with chronic hepatitis C looking specifically at extrahepatic manifestations of the virus (symptoms experienced) and the impact these have on quality of life however the limitation of the existing research is that it has nearly always exclusively been performed in participants who are aware of their diagnosis. This sub-study gives us the unique opportunity to assess this in a purely objective manner, looking at the number of visits made to primary care practitioners prior to diagnosis and looking at what symptoms these individuals presented with which may help with diagnosis of viral hepatitis in the future as well as enable us to assess the impact chronic hepatitis C has on an individual's quality of life.
Research database title
HepFree observational sub-study: The impact of chronic hepatitis C on healthcare utilisation
Establishment organisation
Queen Mary University London
Establishment organisation address
Mile End Road
London
E1 4NS