Healthcare resource utilisation and economic impact among liver transplant patients during the last year before graft failure in the UK: a retrospective observational study

Study type
Protocol
Date of Approval
Study reference ID
15_188
Lay Summary

The main objective of this study is to estimate the total healthcare costs observed in liver transplant patients during the last year before the transplanted liver stops working. A secondary aim is to extend the analysis to up to five years before the transplanted liver stops working.
It is expected that the total annual healthcare costs will be higher in the final year before the transplant stops working compared with previous years. This is in agreement with other studies where the costs in the last year before important medical events have occurred have risen substantially.
The study will provide a detailed understanding of the long-term use of healthcare resources and their costs of liver transplant patients. It can also be used to show how costs of liver transplant patients change during the years before the liver transplant stops working and whether these costs increase the nearer to the time the liver stops working.
These costs can be input into economic studies where different treatments, used to maintain transplanted livers functioning, are compared. Traditionally, little attention has been paid to the assumption that annual costs may change the nearer to the time when the liver transplant stops working.

Technical Summary

The primary objective of this study is the total cost of healthcare resource use observed in the year prior to the date of liver transplant failure. A secondary aim is to extend the analysis to between more than one and five years before graft failure.
This project will constitute a non-interventional, retrospective longitudinal study to analyse anonymous patient data from NHS databases. Patients will be selected from the CPRD/HES on the basis of evidence for liver transplantation between 2004 and 2013 and graft failure between 2005 and 2014.
Costs will be evaluated through models which are based on NHS national costs (2015) for health care consumption and BNF costs for drug utilisation.
The total cost of healthcare resource in the year prior to the graft failure will be analysed descriptively, in terms of distribution of costs, components of total cost and the relationship between individual resource items and total cost.
Continuous and nominal variables will be described using standard statistical measures such as number of observations, mean, standard deviation, minimum and maximum value, median, 1st and 3rd quartiles, and frequencies.
Repeated measures longitudinal modelling will be conducted to estimate the impact of time to graft failure on resource utilisation while adjusting for covariates.

Collaborators

Warren Hart - Chief Investigator - EcoStat Consulting UK Ltd.
Warren Hart - Corresponding Applicant - EcoStat Consulting UK Ltd.
Chris D Poole - Collaborator - Digital Health Labs Limited
Gorden Muduma - Collaborator - Astellas Pharma Europe B.V.

Linkages

HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data