Title: Variations in access to best care for renal replacement therapy patients across the United Kingdom
Funder: Department of Health and Social Care

Abstract: AIMS AND OBJECTIVES: The over arching aims of the project are (1) to improve equity of access to kidney and pancreas transplantation across the UK (2) to optimise organ allocation to maximise the benefit, including cost effectiveness, from kidney and pancreas transplantation. BACKGROUND: Preliminary work has identified the presence of significant inter-centre variability in access to renal transplantation in the UK. However, it is not clear whether patient or unit specific factors, or both, are responsible for inter-centre variability. Further, unit specific factors are yet to be identified by qualitative methods. The absence of an effective tool to guide risk versus benefit assessment in individual patients will perpetuate this inter-centre variability. Development of a survival probability tool, similar to those used to estimate mortality risk in patients awaiting liver transplantation or cardiac bypass surgery, may enable standardisation of access to renal transplantation. Current national kidney allocation algorithms are heavily weighted towards variables such as tissue type but do not take into account possible differences in quality of life, well being, treatment satisfaction or costs associated with transplantation in different patient categories. RESEARCH PLANS: Over a 12 month period, we plan to recruit all incident dialysis and renal transplant patients across the UK as well as matched controls from patients who are currently active on the transplant list. Patient level information will be collected by research nurses embedded in the transplant centres at the time of recruitment. The outcomes of interest would be patient survival, access to the transplant list and achieving transplantation once activated on the list. Qualitative exploration of the processes that shape renal transplantation in each unit will help identify unit specific factors that influence access to renal transplantation. Quality of Life (QoL) analysis of patients on renal replacement therapy as well as comparison of QoL between patients undergoing transplantation versus those remaining on dialysis will be undertaken. A comprehensive health economic analysis of the renal transplantation will also be undertaken in parallel. All patients will be followed for a minimum of three years, with analysis and reporting in the final year of a five year project. RESEARCH TEAM: The research team comprises opinion leaders in the fields of transplant surgery, nephrology, methodology/epidemiology, qualitative research, quality of life assessment, health economics and statistics. This provides the team with sufficient influence to ensure participation from every renal unit across the UK whilst at the same time ensuring the necessary expertise for appropriate data analysis and reporting of findings. RESEARCH ENVIRONMENT: The expertise of the co-applicants in addition to the experience and existing infrastructure of the three national registries maximises the potential for successful outcomes whilst at the same time minimising costs without compromising data quality and security. The UK Renal Registry [UKRR], Scottish Renal Registry [SRR] and NHS Blood and Transplant [NHSBT] are leading national registries with more than 10 years experience in reporting on case mix adjusted centre specific outcomes for patients with end stage renal failure. ANTICIPATED OUTPUTS, OUTCOMES AND IMPACT OF RESEARCH: [1] An understanding of patient and unit specific factors that influence access to renal transplantation in the UK enabling changes to unit practices and policies to reduce inter-centre variability. [2] A patient survival probability model to enable standardisation of access to the renal transplant list within the UK. [3] An understanding of QoL and health economic gains from renal transplantation to inform development of a more sophisticated organ allocation algorithm. PUBLIC INVOLVEMENT: The National Kidney Federation [which is a confederation of regional kidney patients associations from across the UK] is represented by its Chief Executive as one of the co-applicants for this grant. Through the NKF, patients with end stage renal failure are involved in every stage of the project. ETHICAL IMPLICATIONS: National ethical approval to conduct the study will be sought. Participation in the study will not influence any aspect of the delivered care to any of the patients. Patient identifiable information will be stored only on the secure UKRR database which conforms to required safeguards to ensure data security. JUSTIFICATION FOR RESOURCES REQUESTED: The staff costs requested ensure ability to collect and analyse patient level data of robust quality from a statistically defendable number of patients required to fulfil the stated objectives. Utilisation of existing resources at UKRR, SRR and NHSBT has minimised direct non-pay and indirect costs to only the essential items.

Lay abstract: Transplantation has the potential to extend and improve the quality of life for patients with kidney failure. Preliminary work suggests wide variability in access to transplantation between UK kidney units, (i.e. a post code lottery), due to factors that are poorly understood. Given the shortage of available organs it is essential that patient selection for transplantation and the national organ allocation policies are fair, based on best clinical evidence and designed to take account of a range of equity, Quality of Life [QoL] and utility factors. This research proposal aims to understand the reasons behind inter-centre variability as well as develop tools to maximise transplant outcomes in the UK. To achieve this we need to collect detailed information [age, sex, associated medical conditions etc] about patients with kidney failure. We propose to recruit all patients starting dialysis, receiving a transplant and a similar number of matched patients active on the transplant list, from all units in the UK over a one year period. Information on QoL will be obtained by administering questionnaires to the patients. Routine day-to-day clinical care of patients recruited to join the study will not be affected in any way by entering the study. Dedicated, specialist renal research nurses in each unit will collect the required information by reading case notes, talking to the doctors & nurses in each unit and patients directly. Only anonymised data will be analysed and reported, therefore there is no potential for breach of patient confidentiality. Patients will be followed for 3 years after recruitment. The collected data will help us understand which patient factors influence whether patients are put on the waiting list and which patients gain most from transplantation. Parallel assessments of how units perform will help inform why some centres do better. Correlation with quality of life data and cost effectiveness will allow us to develop alternative organ allocation schemes. The findings will benefit patients with kidney failure by providing them with individualised predictions on likely outcomes, to allow informed decision making, along with uniformly applicable and evidence-based assessment criteria for entry onto transplant waiting lists. The development of new organ allocation schemes will explore the possibility of maximising clinical outcomes as well as quality of life after transplantation whilst ensuring best use of all available organs.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: RENAL AND UROGENITAL