title: Access to Transplantation and Transplant Outcome Measures (ATTOM): study protocol of a UK wide, in-depth, prospective cohort analysis.
abstract: BACKGROUND
  There is significant intercentre variability in access to renal transplantation in the UK due to poorly understood factors. The overarching aims of this study are to improve equity of access to kidney and kidney-pancreas transplantation across the UK and to optimise organ allocation to maximise the benefit and cost-effectiveness of transplantation.
  
  
  METHODS
  6844 patients aged 18-75 years starting dialysis and/or receiving a transplant together with matched patients active on the transplant list from all 72 UK renal units were recruited between November 2011 and March 2013 and will be followed for at least 3 years. The outcomes of interest include patient survival, access to the transplant list, receipt of a transplant, patient-reported outcome measures (PROMs) including quality of life, treatment satisfaction, well-being and health status on different forms of renal replacement therapy. Sociodemographic and clinical data were prospectively collected from case notes and from interviews with patients and local clinical teams. Qualitative process exploration with clinical staff will help identify unit-specific factors that influence access to renal transplantation. A health economic analysis will explore costs and outcomes associated with alternative approaches to organ allocation. The study will deliver: (1) an understanding of patient and unit-specific factors influencing access to renal transplantation in the UK, informing potential changes to practices and policies to optimise outcomes and reduce intercentre variability; (2) a patient-survival probability model to standardise access to the renal transplant list and (3) an understanding of PROMs and health economic impact of kidney and kidney-pancreas transplantation to inform the development of a more sophisticated and fairer organ allocation algorithm.
  
  
  BACKGROUND
  The protocol has been independently peer reviewed by National Institute for Health Research (NIHR) and approved by the East of England Research Ethics Committee. The results will be published in peer-reviewed journals and presented at conferences.
authors.affiliation: Transplant Unit, Royal Infirmary of Edinburgh, Edinburgh, UK.
authors.forename: Gabriel C
authors.initials: GC
authors.lastname: Oniscu
authors.affiliation: Richard Bright Renal Unit, Southmead Hospital, Bristol, UK.
authors.forename: Rommel
authors.initials: R
authors.lastname: Ravanan
authors.affiliation: Transplant Unit, Royal Infirmary of Edinburgh, Edinburgh, UK.
authors.forename: Diana
authors.initials: D
authors.lastname: Wu
authors.affiliation: Health Psychology Research Unit, Royal Holloway, University of London, London, UK.
authors.forename: Andrea
authors.initials: A
authors.lastname: Gibbons
authors.affiliation: Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, UK.
authors.forename: Bernadette
authors.initials: B
authors.lastname: Li
authors.affiliation: Department of Renal Medicine, Freeman Hospital, Newcastle upon Tyne, UK.
authors.forename: Charles
authors.initials: C
authors.lastname: Tomson
authors.affiliation: Transplant Unit, Royal Infirmary of Edinburgh, Edinburgh, UK.
authors.forename: John L
authors.initials: JL
authors.lastname: Forsythe
authors.affiliation: Health Psychology Research Unit, Royal Holloway, University of London, London, UK.
authors.forename: Clare
authors.initials: C
authors.lastname: Bradley
authors.affiliation: Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, UK.
authors.forename: John
authors.initials: J
authors.lastname: Cairns
authors.affiliation: Richard Bright Renal Unit, Southmead Hospital, Bristol, UK.
authors.forename: Christopher
authors.initials: C
authors.lastname: Dudley
authors.affiliation: Department of Surgery, University of Cambridge and the NIHR Cambridge Biomedical Research Centre, Cambridge, UK.
authors.forename: Christopher J E
authors.initials: CJ
authors.lastname: Watson
authors.affiliation: Department of Surgery, University of Cambridge and the NIHR Cambridge Biomedical Research Centre, Cambridge, UK.
authors.forename: Eleanor M
authors.initials: EM
authors.lastname: Bolton
authors.affiliation: School of Health and Population Sciences, University of Birmingham, Birmingham, UK.
authors.forename: Heather
authors.initials: H
authors.lastname: Draper
authors.affiliation: NHS Blood and Transplant, Bristol, UK.
authors.forename: Matthew
authors.initials: M
authors.lastname: Robb
authors.affiliation: NHS Blood and Transplant, Bristol, UK.
authors.forename: Lisa
authors.initials: L
authors.lastname: Bradbury
authors.affiliation: UK Renal Registry, Bristol, UK.
authors.forename: Rishi
authors.initials: R
authors.lastname: Pruthi
authors.affiliation: Transplant Unit, Royal Infirmary of Edinburgh, Edinburgh, UK.
authors.forename: Wendy
authors.initials: W
authors.lastname: Metcalfe
authors.affiliation: UK Renal Registry, Bristol, UK.
authors.forename: Damian
authors.initials: D
authors.lastname: Fogarty
authors.affiliation: Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: Roderick
authors.affiliation: Department of Surgery, University of Cambridge and the NIHR Cambridge Biomedical Research Centre, Cambridge, UK.
authors.forename: J Andrew
authors.initials: JA
authors.lastname: Bradley
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D015331:Cohort Studies; D005260:Female; D006297:Health Services Accessibility / Q000706:statistics & numerical data*; D006801:Humans; D016030:Kidney Transplantation / Q000706:statistics & numerical data*; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000706:statistics & numerical data*; D011446:Prospective Studies; D012107:Research Design; D006113:United Kingdom; D014850:Waiting Lists; D055815:Young Adult
keywords: EPIDEMIOLOGY; HEALTH ECONOMICS; QUALITATIVE RESEARCH; TRANSPLANT SURGERY