NHS Digital Data Release Register - reformatted

NHS Blood And Transplant (nhsbt)

Project 1 — DARS-NIC-147815-X5CHM

Opt outs honoured: Y

Sensitive: Sensitive

When: 2016/04 (or before) — 2018/02.

Repeats: Ongoing

Legal basis: Section 251 approval is in place for the flow of identifiable data

Categories: Identifiable

Datasets:

  • MRIS - Flagging Current Status Report
  • MRIS - Cause of Death Report
  • MRIS - Scottish NHS / Registration
  • MRIS - Cohort Event Notification Report

Objectives:

The data supplied by the NHS IC to NHS Blood and Transplant will be used only for the approved Medical research project


Project 2 — DARS-NIC-338242-C8Z8M

Opt outs honoured: Y

Sensitive: Non Sensitive, and Sensitive

When: 2016/12 — 2017/02.

Repeats: One-Off

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC, Section 42(4) of the Statistics and Registration Service Act (2007) as amended by section 287 of the Health and Social Care Act (2012)

Categories: Anonymised - ICO code compliant, Identifiable

Datasets:

  • Hospital Episode Statistics Admitted Patient Care
  • Office for National Statistics Mortality Data

Benefits:

The proposed research will make six fundamental contributions to measurably improving the health of patients suspended on the national kidney waiting list. 1) To increase national awareness of this patient cohort and encourage consultant nephrologists, transplant surgeon, specialist nurses and patients and their families to monitor closely status while active on the national kidney transplant waiting list. 2) To decrease waiting list morbidity and mortality and reduce the number of patients suspended on the list by prioritising those with the greatest clinical need to receive a kidney first. 3) To reduce the number of renal failure related hospital admissions from patients on the waiting list by prioritising those with the greatest clinical need. 4) To aid in the development of a statistical model to dictate NHS BT’s allocation policy for deceased donor kidney transplantation. 5) To produce a reliable data source for future research into improving outcomes in this patient cohort. 6) To encourage the tighter regulation of the national deceased donor kidney waiting list and encourage optimal deceased donor and recipient allocation. In order to determine the full impact of these potential benefits the applicant will first need to use the linked databases to determine how many patients are suspended on the national waiting list, what proportion die whilst suspended from the list and the rate of renal failure related hospital admissions. Once this baseline information is established the applicant can then calculate the true impact of the research in terms of total life years saved and total cost saved through potential implementation of an allocation system based on clinical need.

Outputs:

During the course of this research the applicant would look to publish a minimum of four to five high quality research papers in high impact transplant specific journals. Selected journals include; Transplantation, Transplant International and the American Journal of Transplantation. Intended dates of publication: Submission of Abstract by December 2016 to: January 2017 (allowing for data linkage, validation and analysis) Presentations: Research outputs will be presented at national and international meetings, aiming for yearly presentations at the British Transplant Society (BTS) Conference with international presentations focussed on conferences hosted by the European Society of Transplantation (ESOT); also an oral presentation at the two-yearly World Transplant Conference (WTC). Intended Dates of Presentation: British Transplant Society (BTS): 2017 European Society of Transplantation: 2016 – 2018 World Transplant Congress; 2016 (preliminary work) and 2018 NHS BT: As the national governing body for transplantation in the UK NHS BT will present results to the NHS BT’s Kidney Advisory Group. Intended initial presentation: November 2016 (introduction to the project). Projected updates: 3 months intervals Presentations will be continually given throughout the study as NHSBT generate interesting results - these presentations will be given on a local, regional, national and international basis. The results will also be published in any transplant specific or well recognised international journal. A monthly newsletter containing relevant updates is circulated to the cohort.

Processing:

NHS BT will use the two linked national databases, the NHS BT national kidney waiting list to identify all patients in the UK activated and suspended from the waiting list and the HSCIC outcome data to determine the number and length of hospital admissions and the cause of death of patients both suspended and activated on the list. The validity of this linked data will be checked prior to addressing NHS BT's main research objectives. Data handling and statistical analysis will be led by the Head of Organ and Donation Studies at NHS BT. NHSBT will be providing a study ID within the cohort to enable them to re-identify the data from the pseudonymised output provided to them from the HSCIC. Linking the datasets enhances NHSBT's project by providing information on patient outcome data. In addition linking the data sets allows NHSBT to adjust for more variables during regression analysis thus increasing the internal validity of NHSBT's study by reducing the effect of known confounding variables. NHS BT confirm that all individuals with access to the record level data are employed by NHSBT

Objectives:

A significant proportion of patients initially listed for deceased donor kidney transplantation end up being suspended from the national waiting list. The vast majority of these patients are suspended on the basis of clinically accepted criteria. The outcomes of those patients who remained suspended are predictably poor however the scale of their morbidity and mortality remains alarmingly unknown or underreported. It can be argued these patients represent a forgotten cohort of renal transplant candidates not specifically analysed. However with transplantation known to offer a survival benefit over haemodialysis, attributable in the main to reduction in cardiovascular risk, it is conceivable that earlier allocation of a kidney transplant to these patients could have prevented the development of the clinical deterioration that led to their suspension. Inevitably this leads to difficult questions regarding allocation policy especially as at present there are no current clinical criteria that contribute to the prioritisation of deceased donor kidneys to potential recipients. Based on research already presented at the 2014 World Transplant Conference, NHS Blood and Transplant (NHS BT) wish to link data from patients suspended on the National Kidney Waiting List with outcome data (number and cause of individual hospital admissions and cause of death) from HSCIC to determine the ‘Outcome of potential recipients of a kidney transplant suspended from the national waiting list’ Using the linked outcome data NHS BT aim to address 6 separate objectives: 1) To assess the validity of two linked national databases as a data source for kidney transplant research. 2) To determine the true mortality rate of patients both activated and suspended on the national kidney transplant waiting list over a 10 year period 3) To identify potentially modifiable clinical factors that independently contribute to the mortality of patients activated and suspended on the national kidney waiting list. 4) To perform a literature review identifying whether the clinical factors independently contributing to the death of patients activated or suspended on the waiting list have been proven to be modifiable by earlier renal transplantation. 5) To help NHS BT build a validated survival benefit model that prioritises deceased donor kidney transplantation based proven clinical criteria thus leading to a reduction in waiting list deaths and an overall fairer allocation policy. 6) To determine the economic benefit of earlier transplantation for those with greater clinical need, achieved through cost of renal failure related hospital admissions whilst suspended on the national kidney transplant waiting list. Organisations Involved: i) NHS Blood and Transplant (NHSBT) NHS BT is a Special Health Authority of the Department of Health. It has the responsibility of and raising the quality, effectiveness and efficiency of blood and transplant services in the UK. Amongst its remit is managing both the national transplant waiting lists and national databases containing all organ transplant outcome data. NHS BT is also committed to improving outcome through research and encourages the secure release of its data for research purposes. The project lead (an employee of NHS BT), retains close links to the NHS BT and acts as their Associate National Clinical Lead for Organ Retrieval.