Outcomes of potential recipients of a kidney transplant suspended from the National Waiting List

Civil Registration (Deaths) and HES APC Data was supplied to NHS Blood and Transplant (NHSBT) by the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to as 'Outcomes of potential recipients of a kidney transplant suspended from the National Waiting List'.

This Data Sharing Agreement permits the retention of the data for an interim period but no other processing of the data is permitted.

Permission to retain the data for the interim period is a practical step to enable the study to comply with the necessary legal and ethical requirements. If, for any reason, it is not possible for the study to meet the necessary requirements, this Agreement will be terminated, and destruction of the data will be required.

The following information provides background information on the purpose of the original study. No new data will be released under this version of the agreement, and this agreement allows the applicant to hold and not otherwise process any further data that has already been disseminated.

The following information provides background on the aim and purpose of the original study. no new data will be disseminated under v2 of this agreement.

BACKGROUND

A significant proportion of patients initially listed for deceased donor kidney transplantation end up being suspended from the national waiting list. Many of these patients are suspended based on 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, NHSBT 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 NHS Digital to determine the ‘Outcome of potential recipients of a kidney transplant suspended from the national waiting list’

Using the linked outcome data NHSBT 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 NHSBT 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.

NHSBT have provided the following website where the Medical Director monthly newsletter is published and also is issued to all the transplant community.:

http://www.odt.nhs.uk/

ORGANISATION

i) NHSBT

NHSBT 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. NHSBT 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 NHSBT), retains close links to the NHS BT and acts as their Associate National Clinical Lead for Organ Retrieval.

DATA MINIMISATION

The justification for the number of data years requested has been explored with the applicant who explained that a greater number of years increased number of patients in the study which itself improves the reliability of the statistical analysis. In addition, more years of data will provide a better representation of patients on the Kidney Transplant Waiting list. This in turn improves external validity of the study and thus enhances the possibility of applying the results to other transplant waiting lists in other areas of transplantation (pancreas, liver etc) and potentially other countries. The inclusion of recent years of data (i.e. up to 2015/2016) allows a more up to date analysis of patients (i.e. clinical factors now that are affecting suspension survival on the transplant waiting list against clinical factors from 2000.

All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract ie: employees, agents and contractors of the Data Recipient who may have access to that data).

Civil Registration (Deaths) and HES APC Data was supplied to NHS Blood and Transplant (NHSBT) by the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to as 'Outcomes of potential recipients of a kidney transplant suspended from the National Waiting List'.

This Data Sharing Agreement permits the retention of the data for an interim period but no other processing of the data is permitted.

Permission to retain the data for the interim period is a practical step to enable the study to comply with the necessary legal and ethical requirements. If, for any reason, it is not possible for the study to meet the necessary requirements, this Agreement will be terminated, and destruction of the data will be required.

No new or further data will be provided under v2 of the agreement. A short term extension is in place as a pragmatic approach to enable legal retention of already disseminated data. This agreement allows retention of data, but not permission to otherwise process it.

Below is information provided by NHSBT on background to the study for details of previous disseminations, and also an insight into what is anticipated will happen once access to new data flows and permission to process data is granted in the future. As stated above - this version of the agreement permits retention of data only - permission is not granted to otherwise process the data at this stage until relevant documentation can be provided.

NHSBT will use the two linked national databases:

1. the NHSBT national kidney waiting list to identify all patients in the UK activated and suspended from the waiting list

2. 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 NHSBT's main research objectives.

Data handling and statistical analysis will be led by the Head of Organ and Donation Studies at NHSBT.

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 NHS Digital.

Linking the datasets enhances NHSBT's project by providing information on patient outcome data and 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.

NHSBT confirm only substantive employees of NHSBT will have access to the record level data disseminated by NHS Digital.

Civil Registration (Deaths) and HES APC Data was supplied to NHS Blood and Transplant (NHSBT) by the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to as 'Outcomes of potential recipients of a kidney transplant suspended from the National Waiting List'.

This Data Sharing Agreement permits the retention of the data for an interim period but no other processing of the data is permitted.

Permission to retain the data for the interim period is a practical step to enable the study to comply with the necessary legal and ethical requirements. If, for any reason, it is not possible for the study to meet the necessary requirements, this Agreement will be terminated, and destruction of the data will be required.

No further outputs of the data are permitted to be created under this version of the agreement. The below provides background on to what has already been produced, and what will be produced once data flow and permission to process resumes.

During this research NHSBT 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

NHSBT:

As the national governing body for transplantation in the UK NHSBT will present results to the NHSBT’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.

This Data Sharing Agreement permits the retention of the data for an interim period but no other processing of the data is permitted.

Permission to retain the data for the interim period is a practical step to enable the study to comply with the necessary legal and ethical requirements. If, for any reason, it is not possible for the study to meet the necessary requirements, this Agreement will be terminated, and destruction of the data will be required.

The following information provides background information on the benefits of the original dissemination. No new data will be released under v2 of the agreement, and this agreement allows the applicant to hold and not otherwise process any further data that has already been disseminated.

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.

Not stated in the register.