Impact of Rifaximin-a on patients with Hepatic Encephalopathy
Research type
Research Study
Full title
The Impact of Rifaximin-a on the NHS Hospital Resource Use Associated with the Management of Patients with Hepatic Encephalopathy: A Retrospective Observational Study (IMPRESS)
IRAS ID
156115
Contact name
Richard Aspinall
Contact email
Sponsor organisation
Norgine Ltd
Research summary
Hepatic encephalopathy (HE) is the occurrence of confusion, altered level of consciousness and sometimes coma which occurs commonly in patients with liver cirrhosis due to the effect on the brain of toxic compounds that accumulate in the blood. There are few available treatment options. Rifaximin-a is a non-absorbable antibiotic which can help to reduce the number of HE episodes; it has been available in the UK since January 2013.
This retrospective, observational study aims to describe how rifaximin-a is currently used to manage HE in routine UK clinical practice and the impact on NHS resource use. The study will involve 250-300 patients across 15 centres. The main objective is to compare the number of days spent in hospital for the management of HE in the 6 months before and the 6 months after starting rifaximin-a.
The study will involve the collection of clinical data from the secondary/tertiary care medical records of patients with HE who have received rifaximin-a as part of normal clinical practice. Resource use data for all patients will be obtained from national data providers (e.g. Hospital Episode Statistic (HES) for England, Patient Episode Database for Wales (PEDW) or Information Services Division (ISD) for Scotland). There will be no change to the management of patients for the purposes of the study.
Informed consent from patients will not be sought because patients will be identified and data collected from medical records by members of the NHS direct care team; data will be released to pH Associates (a research consultancy) for analysis and reporting in anonymised-coded form. Patient consent will not be sought for the release of resource use data from national data providers because no patient identifiable are being requested. Data will be provided to pH Associates linked only to the study code with all identifiable data removed.REC name
West of Scotland REC 3
REC reference
14/WS/1017
Date of REC Opinion
13 Jun 2014
REC opinion
Favourable Opinion