NHS Digital Data Release Register - reformatted

NHS Blood And Transplant (nhsbt) projects

459 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).

🚩 NHS Blood And Transplant (nhsbt) was sent multiple files from the same dataset, in the same month, both with optouts respected and with optouts ignored. NHS Blood And Transplant (nhsbt) may not have compared the two files, but the identifiers are consistent between datasets, and outside of a good TRE NHS Digital can not know what recipients actually do.

Equity of access to liver transplantation in the UK (EquiLT-UK): impact of socio-demographic characteristics on registration, organ offering, allocation and transplant outcomes. — DARS-NIC-742898-S7N0V

Opt outs honoured: (Excuses: Section 251 NHS Act 2006)

Legal basis: Health and Social Care Act 2012 - s261(5)(d)

Purposes: No (Agency/Public Body)

Sensitive: Non-Sensitive

When:DSA runs 2025-03 – 2028-03

Access method: One-Off

Data-controller type: NHS BLOOD AND TRANSPLANT (NHSBT)

Sublicensing allowed: No

Datasets:

  1. Civil Registrations of Death
  2. Hospital Episode Statistics Admitted Patient Care (HES APC)
  3. NDRS Cancer Consolidated Data Set

Type of data: Anonymised - ICO Code Compliant

Objectives:

NHS Blood and Transplant (NHSBT) requires access to NHS England data for the purpose of the following research project:
Equity of access to liver transplant in the UK (EquiLT-UK): impact of socio-demographic characteristics on registration, organ offering, allocation and transplant outcomes

The project will be conducted in relation to a PhD qualification at University College London. The burden of liver disease is worryingly increasing and data from 2019 estimate that liver cirrhosis is amongst the top 3 causes of death in people between 30- and 60-year-old in the UK (World Health Organization, WHO 2019). Liver transplantation (LT) remains today the only cure for end stage liver disease, therefore it is of utmost importance that equitable access to this life-saving procedure is guaranteed to everyone in need.
However, the LT process is long, selective, and meticulous and barriers can arise at any stage.

Whilst NHSBT has been collecting data about all the patients registered for liver transplantation, the lack of a chronic liver disease database represent an important barrier to understand the need for liver transplantation in the general population.

Usually, use of data for research is obtained by contacting the participants of the study individually to obtain their consent, but for the purpose of this study, it would be impractical to gain individual consent for such large number of participants, especially as many of this cohort would have unfortunately died.

Therefore, since these data are routinely collected and stored within NHS England, the request is for a list of all patients admitted to English hospitals with liver disease, diagnosed with liver cancer or died of liver disease in the past 20 years.

This is because the history of liver transplantation has been affected by 2 major events: the introduction of the United Kingdom Model for End-Stage Liver Disease (UKELD) score and Local offer allocation in 2008 and the introduction of the Transplant Benefit Score (TBS) and National Liver Offering Scheme (NLOS) in 2018. These two changes in transplant practice would have inevitably affected access to LT and the aim is to capture the changes that have occurred in 3 eras of transplantation: 2004-2008 / 2008-2018 / 2018-2024.

The following is a summary of the aims of the research project provided by or on behalf of NHSBT:

To identify in patients with liver disease the incidence of waiting list registrations, organ offers, transplantations, waiting list mortality and graft/patient survival post-LT, as stratified by sociodemographic factors (including age group, sex/gender, race/ethnicity, SES, and aetiology of liver disease)

The aim is to establish if the demographics and social status of patients who successfully receive a LT are reflective of the ones in need or if they represent a privileged elite. It is an opportunity to assess the fairness of the transplant process, to evaluate different allocation systems over the years and to explore how the COVID pandemic has impacted patients' selection and survival.

This observational study is a retrospective cohort study. It will be divided into three main phases, each linked to a project objective and following a quantitative research design.

1. Phase 1: Analysis of the Waiting List outcomes
Objective: To describe the graft offers and the clinical outcomes of the patients registered for a liver transplant by their sociodemographic characteristics. These will be assessed according to different allocation models and type of registration, with subanalyses by country of registration.

2. Phase 2: Analysis of post-LT outcomes by the main axis of inequalities
Objective: To describe the post-liver transplant clinical outcomes of the patients who received a liver transplant by their sociodemographic characteristics. These will be assessed according to different allocation models, urgency of registration, with subanalyses by country of registration and COVID pandemic status and adjusted by donor factors.

3. Phase 3: National evaluation of the need for liver transplantation in the general population – Access to the Waiting list
Objective: To estimate the need for LT in the general population using a sample of patients available from national databases and to describe the impact of sociodemographic characteristics on the likelihood of being (or not) registered on the liver transplant waiting list.

The following NHS England Data will be accessed:

• Hospital Episode Statistics Admitted Patient Care – necessary to identify patients with indications for liver transplantation and those who had contraindications (for example who were elderly, frail, with dementia, with widespread cancer, with cancer outside of criteria for transplant).
• NDRS Cancer Consolidated Data Set – necessary to identify patients with indications for liver transplantation and those who had contraindications (for example who were elderly, frail, with dementia, with widespread cancer, with cancer outside of criteria for transplant).
• Civil Registrations of Death– is required to identify those who met the criteria for transplant (as established from previous 2 datasets) but were not registered for one (not linked to the UK transplant registry) and died without transplant. This enables the study team to estimate the gap between need and transplants provided.

The level of the Data will be;
• Identifiable – Although pseudonymised data is required back from NHS England, the data (regarding individuals that appear in the United Kingdom Transplant Registry (UKTR) cohort only) still classifies as identifiable as the technical ability to re-identify the NHS England data with the UKTR identifiers remain.

The Data will be minimised as follows:
• Limited to a study cohort identified by NHS England as meeting the criteria: Adults aged 17 years and above, with a recognised indication for liver transplant, during the study period 2004-2024.
• Limited to data between April 2004 – March 2024
• Limited to conditions relevant to the study identified by specific ICD-10 codes provided by NHSBT to NHS England in the range between B15-B19, C22, I81, I85, between K70- K77, plus additional rare disease (E83.0, E83.1) OPCS-4 codes; describing Patients in need for LT" (chronic liver disease with decompensation, end-stage liver disease, liver cancer, etc. Amendments to these codes will be considered based on clinical appropriateness.
• Limited to the following geographic area of England.

NHSBT is the research sponsor and the controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is:
Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;

The lawful basis for processing special category data under the UK GDPR is:
Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

The study is in the public interest because it aims to produce information to guide future decisions over patients’ care. NHSBT is a Health and Social Care Institution and as such will be making the results publicly available and promote changes of public health interest.

The funding comes from multiple sources. Funders include:
• NHSBT – Funding is in place until September 2026.
• Royal Free Charity – Funding is in place until September 2026.

Additional costs related to data requests that cannot be covered by NHSBT, will be supported by the Royal Free Charity (Special Purpose Fund).

The funders will have no ability to suppress or otherwise limit the publication of findings.

Data will be accessed by two individuals, the Principal Investigator and Senior Statistician who are both substantive employees of NHSBT.

Patient and Public Involvement and Engagement (PPIE) activity has been sought through the NHSBT PPIE team, to inform the design, implementation, and outputs for this project.

The NHSBT PPAG (Patient and Public Advisory Group) includes people at all stages of the transplant continuum and their relatives or carers. They represent a heterogenous group of different age, gender, ethnicity, socio-economic status and include individuals with disabilities.

A call for participation has been sent out and members of the NHSBT PPAG had the opportunity to express their interest. Two individuals were selected as part of the Steering Committee to review the research protocol and attend an introductory meeting with the CI. Following this, at least one of them will be required every 6 months for 1-hour meetings to discuss progress and provide feedback. The Project Steering Group has exclusively an advisory role.

Further PPAG support has been sought in the form of focus groups within NHSBT PPAG. 30mins were allocated to the CI to explain the research aims and plan. 1hour time was reserved for participant’s feedback, comments and question.

As a result of the feedback (verbal and written) obtained by the focus group meetings, the following recommendations were acknowledged and implemented:
• Additional discussions took place to clarify that NHS England data of participants who did not apply for NDOO and are not on NHSBT databases will still be included in the study in pseudonymised form in phase 3 of the study (will affect English patients only). A Data Privacy Notice was written and edited by members of the PPAG with experience in patients’ communication and health literacy.

Where individuals have opted out of disease registration by the National Disease Registration Service (NDRS), their data has been permanently removed from the registry and therefore will not be disseminated under this Data Sharing Agreement (DSA). https://digital.nhs.uk/ndrs/patients/opting-out

Expected Benefits:

The results of this study will address an important evidence gap and will be of direct relevance to patients and their clinicians.

From a public perspective, it will provide transparency in the decision-making around listing and allocation of organs; while from an academic point of view, it will provide evidence about Hepatology care provision across the country of national and international relevance.

Enhancing the understanding of the registration, allocation, transplantation, and post LT care processes will provide progress towards tangible solutions to improve equity of access at each level.

This study will help to identify groups of patients and/or geographic areas that would benefit from additional financial or educational support and will be the starting point for further research into targeted interventions.

The use of the data could
• help the system to better understand the health and care needs of populations.
• lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.
• advance understanding of regional and national trends in health and social care needs.
• advance understanding of the need for, or effectiveness of, preventative health and care measures for particular populations
• inform planning health services and programmes, for example to improve equity of access, experience and outcomes.
• inform decisions on how to effectively allocate and evaluate funding according to health needs.
• provide a mechanism for checking the quality of care. This could include identifying areas of good practice to learn from, or areas of poorer practice which need to be addressed.
• support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work).

The overarching goal is for equitable access to better clinical outcomes in patients with advanced liver disease, in line with the ambitions of the NHS Long Term Plan (NHS, 2019), the Core20PLUS5 initiative (NHS, 2021) and the NHSBT “Meeting the Need” report (NHSBT, 2021).

The study results will add to the body of evidence required to identify groups of patients and/or geographic areas that would benefit from additional financial or educational support. Therefore, it aims to be a starting point for further research into targeted interventions and policy decisions within the NHS. For example, significant findings generated by this research may suggest a review of the current offering and allocation schemes and promote their equitability.

The British Liver Trust, the Royal Free Charity, as well as NHSBT, have strong patients and public engagement groups, who have been advocating for patients’ perspectives since the infancy of this research proposal and will support the research team in advertising the findings to a wider audience.

Outputs:

The expected outputs of the processing will be:
• Submissions to peer reviewed journals Hepatology, Liver Transplantation, Frontline Gastroenterology, one submission per year.
• Presentations at British and European Associations for Study of the liver (BASL and EASL) between May and September 2025/26, Royal Society of Medicine (January 2026) International Liver transplant society (ILTS), European society of organ transplantation (ESOT). The dates for presentations are dependent on when the data is received from NHS England.

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The findings from this study will be presented in accordance with guidelines presented in the STROBE statement for observational studies (Strengthening the Reporting of Observational Studies in Epidemiology, 2023).

Channels for dissemination will include academic journals, workshops, professional newsletters, social media, Royal Free Charity channels, public promotion of the research and meetings, such as the British Association for Study of the Liver (BASL), the British Liver Transplant Group (BLTG), the British Transplant Society (BTS), the British Society of Gastroenterology (BSG), the European and American Association for Study of the Liver (EASL and AASLD).

Preliminary data will be presented as abstracts/presentations at conferences within the first 3 years of the project, whilst final data will be submitted for journals publication and disseminated to various channels to members of the public and of different healthcare disciplines (Hepatology, transplant surgery, public health) after completion of the study (3 to 5 years).

Processing:

The NHSBT research team will transfer a list of ICD-10 and OPCS-4 codes describing "Patients in need for LT" (chronic liver disease with decompensation, end-stage liver disease, liver cancer, etc.) and will request NHS England to retrieve all patients matching those diagnosis in the past 20 years on 3 linked datasets: HES-APC, NDRS Cancer Consolidated Data Set and Civil Registration of Death.

This will represent the core group of participants of the study and will be referred to as the "Denominator database".

Alongside this, NHSBT research team will create an extract derived from the central UKTR database, containing data specifically of the patients registered for liver transplantation during the study period, including each participant’s NHS number, date of birth, gender, and postcode (patients’ identifiers) and their liver waiting list Recipient ID number (UKTR Recipient ID). This extract will contain no clinical data and will be sent electronically and securely via Secure Electronic File Transfer (SEFT) to NHS England, where it will be linked to the Denominator database.

At this point, the entire linked database (Denominator + UKTR) will be pseudonymised. NHS England will create a randomly generated study ID for each participant on the denominator database. For participants on the UKTR the corresponding UKTR Recipient ID will be included prior to returning the full database to NHSBT.

NHS England will provide the relevant records from the following datasets to NHSBT.
• Hospital Episode Statistics Admitted Patient Care (HES APC)
• Civil Registrations of Death
• NDRS Cancer Consolidated Data Set

The only Data which will be identifiable from NHS England are NHSBT patients on UKTR as the extract received from NHS England will contain the UKTR Recipient ID. For patients who are not on the UKTR no identifiable data will be included.

The Data will not be transferred to any other location.

NHSBT will store Data on the NHSBT secure servers only, any Data back ups that are made will be stored on NHSBT secure servers.

The Data will be accessed by authorised personnel via remote access.

The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.

For remote access:
- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;
- Access controls granting users the minimum level of access required are in place;
- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;
- Multifactor authentication (MFA) is required for remote access;
- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;
- All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).

Access is restricted to individuals within the Statistics and clinical Research Team at NHSBT who have authorisation from the Principal Investigator. All such individuals are substantive employees of NHSBT

All personnel accessing the Data have been appropriately trained in data protection and confidentiality.

The only linkage that will be performed after the NHS England extract is received, is the linkage of clinical information to those UKTR patients whose NHS numbers, recipient ID, date of birth and sex were sent to NHS England for linkage. For this reason, it was requested that NHS England keep recipient IDs on the extract.

No other datasets will be linked.

No data will be added to patients who were not on the UKTR list sent by the investigators to NHS England.

The following information regarding, Opt-Outs will be available on the patient information privacy sheet and will be published on the NHS Blood & Transplant Research Projects Page https://www.nhsbt.nhs.uk/research-and-development/current-research/research-projects/ where both national opt out and study specific opt outs apply.

National Opt-Out: “If you’ve already opted out of having your NHS data used for research, we
won’t use your data. You can also visit the NHS website to opt out, if you haven’t already:
https://www.nhs.uk/your-nhs-data-matters/”

Study-Specific Opt-Out "If you’re okay with your NHS data being used for other studies but not this one, you can contact the lead researcher, and your data will be removed from this study. However, if you live in England, please be aware that your hospital information is still routinely collected by NHS England and may be included in the analysis without your name (pseudonymised). If you’re not happy with this, you can opt out of NHS data sharing (www.nhs.uk/your-nhs-data-matters) and then opt back in after the study ends. This only applies to people living in England. No hospital data will be used from Scotland, Wales, or Northern Ireland." This opt-out is relevant to participants in the UKTR cohort”.

No identifiable data will be used for non NHSBT patients. For NHSBT patients, identifiable data will be stored separately, and no attempts will be made to re-identify individuals, unless the study PI receives direct opt-out notification from those individuals as stated above. In that case identifiable data will be used to retrieve the patients’ information and remove them.

The personal data that will be retained by the research team will be restricted to the minimum necessary to perform the analysis and include age at admission (no date of birth), Index of deprivation measures (no postcodes), month/year of death (no full date of death).

The database will be kept at NHSBT for the minimum time estimated to be necessary to undertake statistical analyses, in accordance with the retention period established in the NHS Records Management Code of Practice for 2023. This time should not exceed 3 years. Once the analyses will be completed, the de-identified data will be archived for additional 2 years and finally safely deleted by 5 years from their acquisition. NHSBT cyber security team will witness deletion of the data and sign the data destruction document, there will be a video recording of this as confirmation.

There will be no requirement and no attempt to re-identify individuals when using the Data.

R11 - Convalescent Plasma Program (Serum trial) — DARS-NIC-372791-X0H3Q

Opt outs honoured:

Legal basis: CV19: Regulation 3 (4) of the Health Service (Control of Patient Information) Regulations 2002; Health and Social Care Act 2012 - s261(5)(d)

Purposes: No (Agency/Public Body)

Sensitive: Sensitive

When:DSA runs 2020-04 – 2020-09

Access method: One-Off, Ongoing

Data-controller type: NHS BLOOD AND TRANSPLANT (NHSBT)

Sublicensing allowed: No

Datasets:

  1. COVID-19 Hospitalization in England Surveillance System
  2. COVID-19 Second Generation Surveillance System
  3. Personal Demographic Service
  4. SUS plus - Admitted Patient Care (beta version)
  5. GPES Data for Pandemic Planning and Research (COVID-19)
  6. Covid-19 UK Non-hospital Antibody Testing Results (Pillar 3)
  7. COVID-19 Second Generation Surveillance System (SGSS)
  8. COVID-19 General Practice Extraction Service (GPES) Data for Pandemic Planning and Research (GDPPR)
  9. COVID-19 SGSS First Positives (Second Generation Surveillance System)

Type of data: Identifiable

MELODY Study (Mass evaluation of lateral flow immunoassays for the detection of SARS-CoV-2 antibody responses in immunosuppressed people) - COVID-19 related hospitalisations in solid transplant patients — DARS-NIC-685917-H4X8G

Opt outs honoured: No (Excuses: Consent (Reasonable Expectation))

Legal basis: Health and Social Care Act 2012 – s261(2)(c)

Purposes: No (Agency/Public Body)

Sensitive: Non-Sensitive

When:DSA runs 2023-05 – 2026-04 2023.06 — 2023.12.

Access method: One-Off

Data-controller type: IMPERIAL COLLEGE LONDON, NHS BLOOD AND TRANSPLANT (NHSBT)

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Admitted Patient Care (HES APC)
  2. Hospital Episode Statistics Critical Care (HES Critical Care)
  3. COVID-19 Therapeutics (BlueTeq) Data Set

Type of data: Anonymised - ICO Code Compliant

Objectives:

Imperial College London and NHS Blood & Transplant (NHSBT) require access to NHS England data for the purpose of the following research project: “MELODY Study - Mass evaluation of lateral flow immunoassays for the detection of SARS-CoV-2 antibody responses in immunosuppressed people”

The following is a summary of the aims of the research project provided by Imperial College London and NHSBT:

"The study aims to estimate how many immunosuppressed people in the UK have antibodies that may provide protection against COVID-19 after at least 3 vaccines and then assess whether people with antibodies have lower rates of infection and severe outcomes of infection than people without antibodies. The results of this study may help assess the impact of the vaccines on the level of antibody response to COVID-19 across the UK and help guide public health policy towards vulnerable groups."

“The study aims to determine:
1. The proportion of immunosuppressed people who have detectable SARS-CoV-2 antibodies following a primary vaccine course (at least 3 doses), and the demographic, disease, and treatment characteristics that influence antibody status.
2. If the detection of antibodies inversely correlates with subsequent risk of severe acute respiratory syndrome coronavirus-2 infection and/or severity of disease in immunosuppressed people.”

This Data Sharing Agreement (DSA) relates to the following outcome measure:

“The incidence of participants hospitalised due to COVID-19 and deaths due to COVID-19 by 6 months will be presented for those with and without antibodies to SARS-CoV-2 following 3rd or 4th vaccine, and compared as described above if there are sufficient events.”

The following NHS England data will be accessed:
• Hospital Episode Statistics Admitted Patient Care and Critical Care – necessary to evaluate vaccine effectiveness in solid organ transplant recipients in relation to incidence and severity of hospitalisation

The level of the data will be pseudonymised, however NHSBT separately hold the identifiable information of all study participants relating to this DSA on their transplant registry.

The data will be minimised as follows:
• Limited to data for a consented study cohort of solid organ transplant recipients held by NHSBT (~10,000 individuals)
• Limited to data between December 2021 and January 2023
• Excluding one-off day case inpatient and elective admissions

Imperial College London as the research sponsor, and NHSBT as the main collaborator, are joint data controllers as the organisations responsible for ensuring that the data will only be processed for the purpose described above.

Imperial College London’s and NHSBT’s lawful basis for processing personal data under the UK GDPR is:
Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller.

Imperial College London’s and NHSBT’s lawful basis for processing special category data under the UK GDPR is:
Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research and aims to produce publicly available information to inform future decisions over patients’ treatments or care.

The funding is provided by the Medical Research Council. The funding is specifically for the study described. Funding is in place until April 2023.

The MELODY study protocol and acceptability was designed and adapted with patient representatives from several different health charities (Kidney Research UK, Blood Cancer UK, Vasculitis UK, Lupus UK, the Cystic Fibrosis Trust and Kidney Care UK) as well as the NHSBT patient advisory groups.

Expected Benefits:

The findings of this research study are expected to describe the real-world effectiveness of at least three COVID-19 vaccinations against COVID-19 infection, hospitalisation and death in immunosuppressed individuals.

The use of the data could:
• advance understanding of the need for, or effectiveness of, preventative health and care measures for particular populations such as organ transplant recipients
• inform planning health services and programmes, for example to improve experience and outcomes
• support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work)

The results are intended to be used to help provide stratified advice to specific patient groups, rather than classify all immunosuppressed patients at risk. Understanding if and how the detection of antibodies relates to the subsequent risk of SARS-CoV2 infection and/or severity of disease in immunosuppressed individuals could help estimate and/or identify the number of patients who may benefit from additional or alternative treatments given or actions taken to prevent disease. This is hoped to lead to implementation of additional measures targeted towards these individuals, to reduce their future risk of severe disease.

It is hoped that through publication of findings in appropriate media, the findings of this research will add to the body of evidence that is considered by the bodies, organisations and individual care practitioners charged with making policy decisions for or within the NHS or treatment decisions in relation to specific patients.

The findings will also be shared with participants through direct contact and via relevant charities. Findings will also be publicised on social media sites through Facebook and Twitter accounts.

Outputs:

The expected outputs of the processing will be:
• A report of findings to the Department of Health and Social Care (DHSC)
• Submissions to peer reviewed journals

The outputs will not contain NHS England data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:
• Journals
• Public reports
• Press/media engagement
• Public promotion of the research via social media sites (Facebook & Twitter)
• Participant newsletters

The target dates for production and dissemination of the outputs are mid 2023 – early 2024.

Processing:

NHS Blood & Transplant (NHSBT) will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, date of birth and a unique person ID) for the cohort to be linked with NHS England data.

NHS England will provide the relevant records from the HES Admitted Patient Care and Critical Care datasets to NHSBT. The data will contain no direct identifying data items but will contain a unique person ID which can be used to link the data with other record level data already held by the recipient.

The data will be linked at person record level with questionnaire results obtained directly from study participants; NHSBT transplant registry clinical data; and information about vaccinations, subsequent COVID-19 infections or details of any deaths which have been provided by the UK Health Security Agency. The data may also be linked with COVID-19 therapeutics data from NHS England.

Identifying details of all participants are stored separately in NHSBT’s transplant registry. All analyses will use the pseudonymised dataset. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset.

The data will not be transferred to any other location.

The data will be stored on servers at NHSBT.

The data will be accessed onsite at the premises of NHSBT only or the data will be accessed by authorised personnel via remote access. The data will remain on the servers at NHSBT at all times.

Personnel are prohibited from downloading or copying data to local devices.

The data will not leave England at any time.

Access is restricted to employees of the statistics team within NHSBT. All such individuals are substantive employees of NHSBT and have been granted approval by the Information Asset Owner.

Employees or agents of Imperial College London are only permitted to access anonymised data including information derived from NHS England data. Such datasets will adhere to the relevant suppression rules.

All personnel accessing the data have been appropriately trained in data protection and confidentiality.

Analysts from NHSBT will analyse the data for the purposes described in ‘Objectives for Processing’. The NHS England data will not be used for any other purposes or combined with any other datasets other than those detailed in this Agreement.

A multi-centre, randomised, controlled trial evaluating the effects of early high-dose cryoprecipitate in adult patients with major trauma haemorrhage requiring major haemorrhage protocol (MHP) activation. CRYOSTAT2- Application to access 1 year mortality data for recruited patients — DARS-NIC-365492-H6D6V

Opt outs honoured: Yes (Excuses: Section 251 NHS Act 2006)

Legal basis: Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'., Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.

Purposes: No (Agency/Public Body)

Sensitive: Sensitive

When:DSA runs 2021-02 – 2022-08 2021.07 — 2022.08.

Access method: Ongoing

Data-controller type: NHS BLOOD AND TRANSPLANT (NHSBT), QUEEN MARY UNIVERSITY OF LONDON

Sublicensing allowed: No

Datasets:

  1. Civil Registration - Deaths
  2. Civil Registrations of Death

Type of data: Identifiable

Outputs:

The main academic output of this study will be a manuscript submitted for publication in 2022 in an open access international medical journal of broad readership when the trial is completed (e.g. The Lancet, New England Journal of Medicine). Whenever possible, the study team will aim to make publications free to access, depending on journal policies.

The main results will also be widely disseminated by abstracts and presentations at national and international scientific conferences and meetings in the fields of major trauma, pre-hospital medicine, emergency medicine, trauma surgery, haematology and transfusion.

Secondary outputs will be papers describing associated methodology and health economic details of the study. Study findings (including mortality data at a summary group level by treatment arm and non-identifiable) will be presented at stakeholder meetings and at forums specific for interested patient groups.

Outputs will include reporting of mortality data at a summary group level. Due to the number of patients in the trial, there will be no small numbers, outputs will be aggregated with small numbers suppressed. It is envisaged that early phase results evaluating in-hospital outcomes will be released within 3 months of the final participant enrolment. Data on longer term outcomes and health economic evaluation will be published after the 6 month follow up period has been completed.

All participating hospital research teams and Public Advisors in Injury Research (PAIR) group involved with the study will be invited to a close out Investigator’s Meeting to discuss the findings of CRYOSTAT-2.

Members of the CRYOSTAT 2 PAIR group will be enlisted to present and contribute articles on patient forums and public and patient involvement events.

Study results (non-identifiable summary group data by treatment arm) will be made publicly available on several websites, e.g. the CRYOSTAT 2 study website, Centre for Trauma Sciences at QMUL, NHSBT, and Bart’s Charity.

It is expected that there will be wide media interest, with press releases and articles pertaining to the study from QMUL, NHSBT, NIHR and participating hospitals. Study teams will also be very active on Twitter.

Surviving study participants will receive a trial completion newsletter summarising the main results of the trial.

Further interest and outputs may be generated if the results of the trial impact on national and international guidelines for the treatment of major trauma haemorrhage.

Processing:

The primary aim of the CRYOSTAT 2 study is to evaluate the effects of early high-dose cryoprecipitate in adult patients with major trauma haemorrhage, particularly to understand if it reduces mortality. The primary outcome is all-cause mortality at 28 days post-injury and secondary outcomes include all-cause mortality (including death from bleeding) at 6 hrs, 24 hours, 6 months and 12 months from arrival at hospital.

The objective of this DARS application is the collection of NHS Digital mortality data (date of death, cause of death) in patients recruited to CRYOSTAT 2 to calculate survival rates. By capturing the centralised NHS Digital mortality data, it will avoid burdening participants and research teams with additional follow up data capture post-discharge.

Twenty-three Major Trauma Centres (hospitals) across England and Wales are participating in the study. Up to five sites in the United States will also be taking part. This agreement does not apply to the US centres, as mortality data will be collected from these sites separately.

The data will not be shared/used with any other institutions/agencies or US centres. The study statisticians from NHSBT will have access to the NHS Digital data for analysis purposes. However, if required, aggregated data with small numbers suppressed will be viewed by the Chief Investigator (Queen Mary University of London) or Co-Chief Investigator (NHSBT). Data will be viewed in a secure office with a study statistician and not electronically transferred outside NHSBT.

Permission to share patient identifiable data is approved under the National Health Service Act 2006 - s251 - "Control of patient data".

Participating hospitals will securely submit the minimum participant identifiable data set required for linkage to NHS Digital data to NHSBT data managers. This will consist of a unique study identifier, NHS number, forename, last name, date of birth, gender and postcode.

NHSBT data managers will securely receive the data and store it on secure servers. The NHSBT data managers and statisticians have been appropriately trained in data protection and confidentiality as part of NHSBT’s annual mandatory training process. Access to areas where processing will take place requires a secure cardkey and secure logins are used on computers. Access is restricted to only NHSBT data management and statisticians involved in the study who are substantive employees of NHSBT who have been appropriately trained in data protection and confidentiality.

The data will be verified by the statisticians to ensure consistency of data and that current data protection legislation is followed.

NHSBT will securely send the data set required for linkage to NHS Digital. .

NHS Digital will securely receive, process and return data (unique identifier, cause of death, date of death, sex and postcode) to the NHSBT study statisticians who will store it on secure servers with restricted access.

The NHSBT study statistician will only use the data for mortality analysis for CRYOSTAT 2 participants. There will be no further linkage to other data sets.

The data set will be kept for the duration of the CRYOSTAT 2 trial. All patient identifying data will be deleted two years after the end of the study by the study statisticians and data managers. This will be evidenced with quality assurance processes in place. There will be no requirement or attempts to re-identify individuals.

Patient identifying data for trials are kept accordingly to the NHSBT Clinical Trials Unit policy which states that data is kept for two years after study completion to allow for analysis to take place.

This level of data flow is identifiable. There will be no subsequent flows of data.

A multi-centre, randomised, controlled trial evaluating the effects of early high-dose cryoprecipitate in adult patients with major trauma haemorrhage requiring major haemorrhage protocol (MHP) activation. CRYOSTAT2- Application to access 1 year mortality data for recruited patients — DARS-NIC-114652-L3R2T

Opt outs honoured: No (Excuses: Consent (Reasonable Expectation))

Legal basis: Health and Social Care Act 2012 – s261(2)(c)

Purposes: No (Agency/Public Body)

Sensitive: Sensitive

When:DSA runs 2021-02 – 2022-08 2021.07 — 2022.08.

Access method: Ongoing

Data-controller type: NHS BLOOD AND TRANSPLANT (NHSBT), QUEEN MARY UNIVERSITY OF LONDON

Sublicensing allowed: No

Datasets:

  1. Civil Registration - Deaths
  2. Civil Registrations of Death

Type of data: Identifiable

Objectives:

Queen Mary University of London (QMUL) together with NHS Blood and Transplant (NHSBT) is currently undertaking a large multi-centre trial in major trauma funded by the National Institute for Health Research Health Technology Assessment (NIHR HTA ref: 15/57/02). The study is led by QMULs Chief Investigator and NHSBTs Consultant Haematologist and started recruitment in May 2017, which is ongoing.

QMUL are the Sponsor for the study. NHSBT (UKCRC registered Clinical Trials Unit) are the Host Institution managing the day to day activities for the trial, including data collection and analysis. For the purposes of this study, NHSBT (Host Institution) and QMUL (Sponsor) are joint data controllers. NHSBT are the sole data processors. The funder for the study (NIHR HTA) is not a data controller or processor.

Bleeding is a major cause of death in severely injured patients. Many of these patients rapidly develop an abnormality of the clotting system, known as ‘acute traumatic coagulopathy’ (ATC). The two most important abnormalities in ATC are low fibrinogen and increased clot breakdown. It has been hypothesised (and there are some non-randomised studies that show this) that in treatment of major trauma patients who are massively bleeding, fibrinogen therapy stops bleeding more effectively than standard care, reduces transfusion needs and may reduce death rates.

Patients who have severe bleeding after injury develop a problem with their clotting system which means that they tend to bleed more. One of the main problems is due to low levels of fibrinogen, a clotting protein normally circulating in the bloodstream. Fibrinogen acts as the ‘glue’ which holds a blood clot together and at low levels, blood clots don’t form properly and bleeding can continue. Cryoprecipitate is a frozen blood component prepared from plasma and rich in fibrinogen. By transfusing a high dose of Cryoprecipitate (e.g. 3 pools of cryoprecipitate equivalent to 15 single units cryoprecipitate or 6g fibrinogen supplementation) early to replace fibrinogen levels in bleeding trauma patients we believe blood clots will be more stable and reduce bleeding.

The primary aim of the multi-centre, randomised controlled trial evaluating the effects of early high-dose cryoprecipitate in adult patients with major trauma haemorrhage requiring major haemorrhage protocol (MHP) activation study, CRYOSTAT 2 study (for short), is to evaluate the effects of early high-dose cryoprecipitate in adult patients with major trauma haemorrhage, particularly to understand if it reduces mortality. The primary outcome is all-cause mortality at 28 days post-injury and secondary outcomes include all-cause mortality (including death from bleeding) at 6 hrs, 24 hours, 6 months and 12 months from arrival at hospital. This is an unblinded parallel group randomised control trial with two cohorts – the intervention group will receive 3 pools of cryoprecipitate within 90 minutes of arrival at hospital plus the standard major haemorrhage protocol; the control group will be treated with the standard major haemorrhage protocol only. The study is only recruiting these specific patients and the applicants are requesting data for those patients only.

CRYOSTAT 2 is a follow-on trial from a previous pilot study, CRYOSTAT 1, which showed early replacement of fibrinogen with Cryoprecipitate can rapidly restore fibrinogen levels and may halve mortality for patients with major trauma haemorrhage. No NHS Digital data was collected/analysed as part of the CRYOSTAT 1 pilot study.

As part of the CRYOSTAT 2 informed consent process, patients can confirm or refuse consent for their identifiable data to be recorded and used for the purpose of the trial. Consented participants can withdraw from the study at any time. CRYOSTAT 2 research teams will always respect the wishes of participants in accordance with NHS guidance on good clinical practice. Another Agreement NIC-365492-H6D6V provides the detail on the cohort that relies on Section 251.

This study has the potential to change national and international clinical guidelines in the treatment of this patient group.

The objective of this DARS agreement is the collection of NHS Digital mortality data (date of death, cause of death) in patients recruited to CRYOSTAT 2 to calculate survival rates. Identifiable data is required to enable matching of NHS Digital data with CRYOSTAT-2 participants. As participants may not survive post-discharge, it is only by capturing the centralised NHS Digital mortality data that post-discharge survival rates can be calculated. By using NHS Digital data, NHS BT avoid burdening participants and research teams with additional follow up data capture. Identifiable data will be kept for two years after the trial is completed to enable analysis to take place, after which it will be destroyed.

The lawful basis for processing of data in this study are GDPR Article 6(1) e, and Article 9(2) j; Article 6(1)e: processing is necessary for the performance of the trial, which is carried out in the public interest. Article 9(2)j: Archiving, research and statistics. Data is only sought for participants who have provided written consent.

All participants will be enrolled in the study without informed participant consent due to the emergency nature of the trial (i.e. a “waiver of consent” will be applied). The participant will then be randomised, and the allocated intervention will be delivered within ninety minutes. This may be before the participant regains capacity or there is any opportunity to identify and approach a personal consultee. As a result, consent can only be sought for the participant to remain in the study through the ongoing collection of follow-up data, and “retrospective consent” for the administration of cryoprecipitate is not possible.

As soon as appropriate, after the administration of the intervention, a personal consultee for the participant will be identified and approached, given an information sheet and asked to provide their advice for the participant to remain in the trial. If the participant remains incapacitated and a personal consultee is not available, or if approaching the personal consultee is likely to induce a delay or it is deemed by the research team to be inappropriate to approach the personal consultee, advice from a professional consultee will be sought.

For the purpose of this study, a professional consultee is defined as a clinician (qualified doctor or registered nurse) with appropriate training (according to local Trust policies) to take on the role of professional consultee. Professional consultees must not be directly
involved in the patient’s care and cannot be a member of the core research team at site. Professional consultees should be aware of the aims of the study and know what the intervention is.

Sites should obtain the advice of a professional consultee as soon as possible after randomisation to enable continued collection of data should the patient be discharged/self-discharge/transferred to another NHS Trust before the research team can approach the patient and/or personal consultees for consent/advice.

The research team will monitor the ongoing status of the participant and their ability to provide informed consent. If the participant does not regain capacity, a personal and/or professional consultee’s advice is sufficient for the participant to remain in the study for the ongoing collection of follow-up data at site up to day 28, discharge or death.

Outputs:

The main academic output of this study will be a manuscript submitted for publication in 2022 in an open access international medical journal of broad readership when the trial is completed (e.g. The Lancet, New England Journal of Medicine). Whenever possible, the study team will aim to make publications free to access, depending on journal policies.

The main results will also be widely disseminated by abstracts and presentations at national and international scientific conferences and meetings in the fields of major trauma, pre-hospital medicine, emergency medicine, trauma surgery, haematology and transfusion.

Secondary outputs will be papers describing associated methodology and health economic details of the study. Study findings (including mortality data at a summary group level by treatment arm and non-identifiable) will be presented at stakeholder meetings and at forums specific for interested patient groups.

Outputs will include reporting of mortality data at a summary group level. Due to the number of patients in the trial, there will be no small numbers. It is envisaged that early phase results evaluating in-hospital outcomes will be released within 3 months of the final participant enrolment. Data on longer term outcomes and health economic evaluation will be published after the 6 month follow up period has been completed.

All participating hospital research teams and Public Advisors in Injury Research (PAIR) group involved with the study will be invited to a close out Investigator’s Meeting to discuss the findings of CRYOSTAT-2.

Members of the CRYOSTAT 2 PAIR group will be enlisted to present and contribute articles on patient forums and public and patient involvement events.

Study results (non-identifiable summary group data by treatment arm) will be made publicly available on several websites, e.g. the CRYOSTAT 2 study website, Centre for Trauma Sciences at QMUL, NHSBT, and Bart’s Charity.

It is expected that there will be wide media interest, with press releases and articles pertaining to the study from QMUL, NHSBT, NIHR and participating hospitals. Study teams will also be very active on Twitter.

Surviving study participants will receive a trial completion newsletter summarising the main results of the trial.

Further interest and outputs may be generated if the results of the trial impact on national and international guidelines for the treatment of major trauma haemorrhage.

Processing:

The primary aim of the CRYOSTAT 2 study is to evaluate the effects of early high-dose cryoprecipitate in adult patients with major trauma haemorrhage, particularly to understand if it reduces mortality. The primary outcome is all-cause mortality at 28 days post-injury and secondary outcomes include all-cause mortality (including death from bleeding) at 6 hrs, 24 hours, 6 months and 12 months from arrival at hospital.

The objective of this DARS application is the collection of NHS Digital mortality data (date of death, cause of death) in patients recruited to CRYOSTAT 2 to calculate survival rates. By capturing the centralised NHS Digital mortality data, it will avoid burdening participants and research teams with additional follow up data capture post-discharge.

Twenty-three Major Trauma Centres (hospitals) across England and Wales are participating in the study. Up to five sites in the United States will also be taking part. This agreement does not apply to the US centres, as mortality data will be collected from these sites separately. The data will not be shared/used with any other institutions/agencies or US centres."

The data is only to be used for research analysis purposes and will not be shared/used with any other institutions/agencies or US centres. The study statisticians from NHSBT will have access to the NHS Digital data for analysis purposes. However, if required, aggregated data with grouped mortality and small numbers suppressed will be viewed by the Chief Investigator (Queen Mary University of London) or Co-Chief Investigator (NHSBT). Data will be viewed in a secure office with a study statistician and not electronically transferred outside NHSBT.

Permission to share patient identifiable data is achieved by signed informed consent.

Participating hospitals will securely submit the minimum participant identifiable data set required for linkage to NHS Digital data to NHSBT data managers. This will consist of a unique study identifier, NHS number, forename, last name, date of birth, gender and postcode.

NHSBT data managers will securely receive the data and store it on secure servers. The NHSBT data managers and statisticians have been appropriately trained in data protection and confidentiality as part of NHSBT’s annual mandatory training process. Access to areas where processing will take place requires a secure cardkey and secure logins are used on computers. Access is restricted to only NHSBT data management and statisticians involved in the study who are all substantive employees of NHSBT who have been appropriately trained in data protection and confidentiality.

The data will be verified by the statisticians to ensure consistency of data and that current data protection legislation is followed.

NHSBT will securely send the data set required for linkage to NHS Digital.

NHS Digital will securely receive, process and return data (unique identifier, cause of death, date of death, sex, postcode) to the NHSBT study statisticians who will store it on secure servers with restricted access.

The NHSBT study statistician will only use the data for mortality analysis for CRYOSTAT 2 participants. There will be no further linkage to other data sets.

The non-derived data set will be kept for the duration of the CRYOSTAT 2 trial. All patient identifiable data will be deleted two years after the end of the study by the study statisticians and data managers. This will be evidenced with quality assurance processes in place. There will be no requirement or attempts to re-identify individuals.

NHS BT will compare NHS Digital data with information held for CRYOSTAT 2 participants on when the patient was admitted to hospital and create (derive) a flag that indicates whether or not the trial participant was alive or dead 28 days after hospital admission. This new variable would have been derived from the NHS Digital data received.

Patient identifiable data for trials are kept accordingly to the NHSBT Clinical Trials Unit policy which states that data is kept for two years after study completion to allow for analysis to take place.

This level of data flow is identifiable. There will be no subsequent flows of data.

Convalescent Plasma (Vaccination Linkage) — DARS-NIC-476579-S9J4D

Opt outs honoured: No (Excuses: Consent (Reasonable Expectation))

Legal basis: Consent (Reasonable Expectation); Health and Social Care Act 2012 – s261(2)(c), Health and Social Care Act 2012 – s261(2)(c)

Purposes: No (Agency/Public Body)

Sensitive: Sensitive

When:DSA runs 2021-09 – 2024-09 2021.12 — 2022.05.

Access method: One-Off

Data-controller type: NHS BLOOD AND TRANSPLANT (NHSBT)

Sublicensing allowed: No

Datasets:

  1. COVID-19 Vaccination Status

Type of data: Identifiable

Objectives:

NHS Blood and Transplant (NHSBT) require the support of NHS Digital in providing vaccination status on their registered donors. NHSBT routinely collects plasma from 50,000 individual records donors who have registered directly with them as part of their statutory functions.

NHS Blood and Transplant (NHSBT) are the sole Data Controller who also processes data for this application.

All donors have consented to use the data NHSBT collects as part of the donation process “for research, to improve our knowledge about the donor population and the possible health effects of blood donation. This may include linkage of your information to your other NHS records”.

Data provided by NHS Digital will be used to identify which blood donors registered with NHSBT who have previously donated convalescent plasma have been vaccinated and when they were vaccinated. NHSBT require information on the type of vaccine given to each donor and the date of each dose, as well as indicators as to if donors have not been vaccinated.

The convalescent plasma identified will be used in the REMAP-CAP trial (https://www.remapcap.org/). The chief medical officer has approved the trial to assess the use of plasma from vaccinated donors who have previously had a natural SARS-CoV-2 infection in patients who have been hospitalised with COVID-19 and are immunosuppressed.

This data will only be used to:
• identify the units of convalescent plasma currently in storage that can be used within the REMAP-CAP trial, or other ethically approved trials of convalescent plasma or hyperimmune globulin.
• identify which donors, who are now plasma for medicine donors, can also provide new plasma donations for the REMAP-CAP trial or other COVID-19 convalescent plasma or hyperimmune trials that may be approved in the future.
• Identify which blood donors, who were previous convalescent plasma donors, have been vaccinated to assess whether vaccination leads to higher levels of other antibodies e.g. anti-A and anti-B antibodies in plasma-containing components.

The data provided by NHS Digital will not be used by any other party than NHSBT.

NHSBT research, in association with the SUPPORT-E consortium (The Pan-European project SUPPORT-E (SUPPORTing high-quality evaluation of COVID-19 convalescent plasma throughout Europe)), has shown that the anti-SARS-CoV-2 antibody levels in plasma collected from donors who have a natural infection and then are vaccinated are up to ten times higher than those who have not been vaccinated. It is also known that plasma from donors who have been vaccinated demonstrates effective neutralisation of the delta and beta variants of the virus in laboratory assays, whereas stored convalescent plasma from unvaccinated donors is not effective against current variants (unpublished data from C-VELVET study - NCT04954937).

Under GDPR, the Recipient can rely on Article 6(1)(e) "processing is necessary for the performance of a task in the public interest or in the exercise of official authority vested in the controller". NHS Blood and Transplant is an executive non-departmental public body and considered a special health public authority. The linkage of donor records and vaccination data is essential for identification of these donors and plasma units, to use the plasma and so to improve the provision of health care and treatment for patients in the NHS

As this is health information and therefore special category personal data the Recipient can also rely on Article 9(2)(h) – "processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3." NHSBT are requesting NHS Digital data to improve the provision of health care and treatment. The data requested, when combined with existing donor records, will allow rapid identification of donors and/or stored plasma units likely to have high levels of anti-SARS-CoV-2 Spike antibodies. Plasma from these donors or the respective stored units could be used to treat patients and/or select units for fractionation of plasma. NHSBT have shown independently in their donors (and consistent with other published work) that a high proportion of donors who had good levels of antibody after natural infection and who are then vaccinated (with any of the approved vaccines) have a high likelihood of developing very high titre of cross-reactive neutralising antibodies to the SARS-CoV-2 (COVID) virus. The linkage of donor records and vaccination data is essential for identification of these donors and plasma units, to use the plasma and so to improve the provision of health care and treatment for patients in the NHS.


NHS Digital is able to process and share COVID-19 tactical data strictly in relation to the current outbreak of Covid-19 under a notice issued to NHS Digital by the Secretary of State for Health and Social Care under Regulation 3(4) of the Health Service Control of Patient Information Regulations (COPI). In this agreement, NHS Digital have satisfied themselves that NHSBT’s purpose for use of Covid-19 Vaccination data aligns to Regulation 3(1) of COPI.

The common Law Duty of Confidentiality for identifiable data being supplied to NHS Digital from NHSBT, and for NHSBT to re-identify individuals from the pseudonymised data supplied by NHS Digital is lifted by the use of Consent (reasonable expectations). NHS Digital have satisfied themselves that the consent materials supplied to participants are compatible with consent (reasonable expectations) and that this request is appropriate, necessary and proportionate for the performance of the task described in the Purpose statement and that there is no other reasonable means for the data processor to achieve their purpose that is less intrusive to the data subjects.

Outputs:

Data will be used to identify stored plasma that can be used within the REMAP-CAP trial – an urgent public health trial and any additional COVID-19 related trials that have been prioritised by the Clinical Trials Accelerator Platform (CTAP) or the Therapeutics Task Force and have been ethically approved. REMAP-CAP trial plans to restart as soon as data are available on suitable plasma donors (September to October 2021).

Data will also be used to easily identify current blood donors who could donate plasma for these prioritised trials. As soon as data are available from NHS Digital this data will be processed and donors identified.

Only aggregated reports with small number suppression applied as per the HES Analysis guidance will be produced and reported internally and to the Department of Health and Social Care (DHSC). The DHSC has funded the collection of the stored convalescent plasma units as part of the convalescent plasma programme.

Processing:

NHSBT will send a donor cohort of approximately 50,000 individual records to NHS Digital from their donor database to identify the vaccination status of blood donors. The cohort will be all blood donors registered with NHS Blood and Transplant (resident in England) who have completed at least one convalescent plasma or plasma for medicine donation, from April 2020 to the present (i.e. approximately 2 days before the extract is created).

Data NHSBT will send a cohort to NHS Digital via Secure Electronic File Transfer Service (SEFT) which will include:
• A unique identifier – to enable linkage of the vaccine data back to NHSBT’s database (a Study ID for pseudonymisation purposes)
• NHS Number if available – this is the only field which will be partially complete (approximately 20% of donors)
• Person First name
• Person Surname
• Person Gender
• Date of birth
• Post code

Data NHSBT require the following data product fields in return:
• The unique identifier provided (Study ID)
• Date and time
• VACCINATION_PROCEDURE_CODE
• NOT_GIVEN
• VACCINATION_SITUATION_CODE
• REASON_NOT_GIVEN_CODE
• DOSE_SEQUENCE
• VACCINE_PRODUCT_CODE
• TOKEN_PERSON_ID

Therefore data sent back to NHSBT via SEFT will be pseudonymised. Data from NHS Digital will then be linked to the NHSBT donor database (PULSE) held securely within NHSBT servers so that relevant donors and plasma donations can be identified. This will be a one-off linkage and any additional linkages will require an amendment to this agreement.

Data received from NHS Digital will only be used by NHSBT for the purposes stated in this agreement. Only a limited number of NHSBT substantive employees can access the PULSE database.

Data will only be processed by substantive employees of NHSBT who are members of the statistics team and NHS Digital data will be held within NHSBT premises in Bristol on secure servers. Statistical data analysis will be carried out via NHS Blood and Transplant owned remote device connected to the NHSBT network either directly in person or remotely, using an appropriate statistical package. To remotely access the NHSBT network requires a secure authenticator (Citrix) and users are then able to securely access the PULSE database secure server on the NHSBT’s IT framework. All data analysis will be conducted within the confines of the NHSBT’s secure server, and will not be downloaded to remote devices for storage or processing.

MELODY Study (Mass evaluation of lateral flow immunoassays for the detection of SARS-CoV-2 antibody responses in immunosuppressed people) - Transplant Patients — DARS-NIC-619023-C7K5V

Opt outs honoured: Yes (Excuses: Section 251 NHS Act 2006)

Legal basis: Health and Social Care Act 2012 – s261(7); Other-National Health Service Act 2006 - s251 - 'Control of patient information'. ,

Purposes: No (Agency/Public Body)

Sensitive: Non-Sensitive

When:DSA runs 2022-03 – 2025-02 2022.03 — 2022.04.

Access method: One-Off

Data-controller type: IMPERIAL COLLEGE LONDON, NHS BLOOD AND TRANSPLANT (NHSBT)

Sublicensing allowed: No

Datasets:

  1. Demographics

Type of data: Identifiable

Expected Benefits:

It is anticipated that the data may help the study to:

1) Quantify the proportion of immunosuppressed patients who have detectable SARS-CoV-2 antibodies following a primary vaccine course (at least 3 doses). This will inform patients, clinicians and those who devise health policy of the numbers of immunosuppressed people in the UK who have not responded to the SARS-CoV-2 by developing antibodies. This will pave the way to protect them in other ways, for example by additional targeted protection with prophylactic monoclonal antibody treatments (a monoclonal antibody given as a preventative treatment. An antibody is a protein that is naturally produced by the immune system in response to an infection. A monoclonal antibody is a molecule developed in a laboratory that is designed to mimic or enhance the body’s natural immune system response against an invader, such as the SARS-CoV-2 virus).
target date - February 2022.

2) Description of and the demographic, disease, and treatment characteristics that influence antibody status. This will allow stratification of the whole group of people who are immunosuppressed into groups at different risks of having no detectable antibodies to SARS-CoV-2 following their 3rd or 4th primary vaccination. This will inform which groups may benefit from targeted strategies such as prophylactic monoclonal antibodies. Target date March 2022.

3) Understanding if the detection of antibodies inversely correlates with subsequent risk of SARS-CoV2 infection and/or severity of disease in immunosuppressed individuals. This will further inform the potential need for additional measures targeted towards these individuals. Target date - July 2022.

Outputs:

The outputs will be a report for the Department of Health and Social Care (DHSC) to inform health policy, and papers in the peer-reviewed medical literature to make the results available for the benefit of all. Target date for report of antibody prevalence - Feb 2022; target date for full study results publication in the medical literature - up to and including Oct 2022.

Processing:

NHSBT will be sending NHSD the NHS number of approx. 40,000 eligible transplant recipients identified through the UK Transplant Registry. NHS Digital are requested to provide the contact details (from PDS), (approx. 40,000), in one drop to Ipsos MORI. If records do not match they will be excluded from the data disseminated to Ipsos MORI.

Imperial and NHSBT have a Data Processing Agreement with Ipsos Mori, that has the provisions for sharing data outside of the UK for example standard contractual clauses within their Data Processing Agreement.

The contact details will be used to contact up to 40,000 people to ask them to register and consent to complete the test - stopping when 10,000 have consented to do this. In order to do this each person will be sent a letter by an approved print supplier (Formara Ltd). If they agree they will register online which will then trigger a test being sent to their address by Formara Limited. The test is then self-administered and the participant is asked to take part in a short online or telephone survey including information on demographic variables, household composition and their medical condition.

Ipsos MORI will use the following PDS data to programme the online registration/survey and data collection platform at Tivian GmbH:
~ sample source
~ first name
~ surname
~ serial ID

Tivian GmbH will then hold the consented cohort data on their servers. All suppliers are GDPR and UK GDPR compliant.

Name and address information is held securely and separately from the survey data, for example, there is controlled and restricted access to the computer system where this information is stored at Ipsos MORI. The personal data is only used by Ipsos MORI for the purpose of inviting people to take part in the research, and confirming the identities of people who register for the study or contact the helpline. No identifiable data is shared outside the research team (unless participants consent to data linkage or to be contacted about future research). All published outputs will be aggregated with small numbers suppressed.

If participants do not consent to further data linkage they will be withdrawn from the second part of the study (aim 2: If the detection of antibodies inversely correlates with subsequent risk of SARS-CoV-2 infection and/or severity of disease in immunosuppressed people) as outcome measures for the second part require linkage to other datasets within NHSBT.

The identifiable patient level data is used to invite patients to register to take part in the research.

All employees involved in the processing are substantive employees of the data processing organisations and are appropriately trained in data protection and confidentiality. Ipsos MORI is certified to ISO 27001 the international standard for Information Security and ISO 20252 the international standard for market research. All employees sign contracts that include appropriate confidentiality clauses, requiring them to comply with relevant data protection policies and procedures. Information Security and acceptable use policies and procedures include clauses that clearly define unauthorised use and/or deliberate misuse, disclosure, loss or destruction as misconduct, with appropriate links to disciplinary procedures. Policies and procedures also include clear warnings that such actions may also lead to legal action against those involved.

All suppliers (for printing and online survey delivery) are approved suppliers (also certified to ISO 9001 and ISO 27001) and UK GDPR Article 28 compliant agreements are in place.

All personal data held in delivering this survey will be subject to appropriate security measures to ensure it is kept secure from accidental or deliberate loss, destruction or disclosure. All organisations handling personal data are accredited to the international standard for information security (ISO 27001), which requires an information security policy documenting their approach.

In terms of technical measures, all users have their own login and password, and access controls are based on user accounts with rights automatically controlled by ‘Active Directory’ group security policy objects.

Access to patient identifiable data will be restricted to the minimum number of personnel; all of whom have undergone training in data protection law, their duty of confidentiality under contract and in the care and handling of personal data.
Any locations containing patient identifiable information would have restricted access to a limited number of project team members, with access rights regularly reviewed.

Where data needs to be transferred, this will be done via SEFT (with NHS Digital). Controls extend to data destruction policies, with electronic data destroyed using approved shredding software, to agreed timescales, and evidenced by destruction certificates stored in the project folder.

The NHS Digital data will not be used for any other purposes or combined with any other datasets other than those detailed in this Agreement.

Request for HES Data to analyse outcomes in the NIHR-funded ATTOM study — DARS-NIC-14342-Q8W0X

Opt outs honoured: Y (Excuses: Section 251 NHS Act 2006)

Legal basis: Health and Social Care Act 2012, Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 - s261 - 'Other dissemination of information', Health and Social Care Act 2012 – s261(2)(b)(ii)

Purposes: No (Agency/Public Body)

Sensitive: Non Sensitive, and Non-Sensitive

When:DSA runs 2019-01 – 2021-09 2018.03 — 2018.05.

Access method: One-Off

Data-controller type: NHS BLOOD AND TRANSPLANT (NHSBT)

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Outpatients
  2. Hospital Episode Statistics Accident and Emergency
  3. Hospital Episode Statistics Admitted Patient Care
  4. Hospital Episode Statistics Accident and Emergency (HES A and E)
  5. Hospital Episode Statistics Admitted Patient Care (HES APC)
  6. Hospital Episode Statistics Outpatients (HES OP)

Type of data: Anonymised - ICO Code Compliant

Objectives:

The Access to Transplant and Transplant outcome measures (ATTOM) study is a UK-wide cohort study of patients with kidney disease receiving dialysis or with a kidney transplant. Its aim is to investigate patient-specific factors which influence progress and outcomes. Baseline data were collected from 2011-2013 and include the results from patient surveys and case notes review for 6842 patients (which included 1139 patients from Wales, Northern Ireland and Scotland, who are not included in the proposed data linkage, ie: cohort size 6842-1139=5703).

Study data contain details of patients’ comorbidities, markers of socioeconomic status such as education, employment, marital status and accommodation, demographics and health literacy (as defined by the Single-item literacy screener: a validated measure of individual health literacy, which is the question ‘How often do you need to have someone help you when you read instructions, pamphlets or other written material from your doctor or pharmacy’, answered on a 5-point scale, with responses 1-Never, 2-Rarely, 3-Sometimes, 4-Often and 5-Always. Responses ‘Sometimes’, ‘Often’ and ‘Always’; See Taylor et al Kidney International Issue 90; vol 3; Pages 685-695).

Patients with advanced kidney disease such as those included in ATTOM have high rates of comorbidity, especially in the form of cardiovascular disease. Because of these comorbidities as well as complications of dialysis or transplantation, they have a high rate of contact with hospital services (emergency care, admissions, outpatients). Data from HES contain details recorded as a result of hospital care, which can be used to examine healthcare use, expenditure and comorbidity, and its relationship to patient-specific factors such as socioeconomic status and health literacy. ATTOM data will be linked to HES (ONS mortality data will be linked at a later date subject to the legal basis being gained) data to allow:

a) Analysis of variations in healthcare utilisation and cost (admission rate, hospital bed days, HRG tariff remuneration, clinic attendance, Emergency Department attendance) in relation to health literacy, socioeconomic status and comorbidity.
b) Comparison of comorbidity data from HES (derived from diagnoses and procedural entries before and during the ATTOM study period, hence start point in 2006) to comorbidity data from the ATTOM dataset (collected by a research nurse from patients’ medical notes), to establish if HES-derived comorbidity data is equal in quality and scope to researcher-collected data from the ATTOM dataset.
c) Survival analysis (from HES initially and linked to ONS mortality data at a later date) in relation to health literacy, socioeconomic status and comorbidity.

Although the linkage of HES data was not specified in the original ATTOM study protocol, the above analyses fit within the first overarching aim of the ATTOM study: to improve equity of access to kidney and pancreas transplantation across the UK. These analyses are primarity concerned with equity of access to treatment and equity of outcome by socioeconomic status and associated factors (including health literacy). By analysing hospital admissions data in this patient group we aim to develop insight into the ways in which socioeconomic factors and health literacy influence patient pathways and may limit access to transplantation. Part b) of the above relates to a specific question about analysis of socioeconomic status in prospective studies (specifically in CKD). Low socioeconomic status is associted with higher comorbidity but also independently with adverse health outcomes. It may be that these factors interact: patients with the same reported baseline comorbidity data but with differing socioeconomic status may develop further comorbidities more quickly (or baseline comorbidities may be more severe in those with low socioeconomic status). In analyses of outcomes, it is difficult to differentiate the effects of comorbidity from the effects of socioeconomic status. This analysis will allow us to compare the consequences of similar comorbidities between patients in different socieoconomic groups. It will be of relevance to the interpretation of our results and to the wider research community.

The data will only be used for this purpose.

When the application for data was submitted the data was expected to be available to be analysed and reported a in the doctorate thesis. At the time of CAG application, the data were still expected to contribute to the above doctorate thesis, so the CAG approval makes reference to this doctorate. However, because data were not available, they were not able to be included in the doctorate thesis, which has now been completed. Data from this linkage will therefore not contribute to a doctorate thesis, but the aim is (and always was) for the analyses to be performed as previously planned. The primary aim of this linkage was not to support a doctorate (as evidenced by the above, adequate data were already available to do so), but to advance knowledge of Chronic Kidney Disease and disseminate these findings as set out in the later sections of this application. The research protocol was amended to include the addition of HES linkage to ATTOM data-set to evaluate outcomes based on health literacy.


Yielded Benefits:

Processing of the HES data has started - the data have been cleaned, and cost data is being generated using the HRG grouper. This will allow the analyses above to proceed. None of the above benefits have yet been acheived, in line with the timeline of the original application. The extension is required to allow continuation of this work.

Expected Benefits:

Research using ATTOM/HES data (and future ONS mortality data pending legal basis obtained) examining variations in healthcare use and expenditure in the context of health literacy, socioeconomic status and comorbidity will expand current knowledge.

For example, results from ATTOM have shown that socioeconomic inequity in access to kidney transplantation appears to be driven in part by health literacy differences. Analysis of healthcare service use data allows more detailed examination of mechanisms underlying this association, and would inform policy changes to reduce inequity (possibly by targeting low health literacy groups). Demonstration of higher healthcare costs (from PbR data) among those with low health literacy would add weight to the promotion of initiatives to improve access to care for this group (with resulting reductions in inequity).

Benefits to health and social care will be measureable at the point of dissemination of results, target date August 2020.

Achievement of these objectives will be of relevance to the population of NHS patients receiving dialysis treatment, or living with a kidney transplant (the number of patients in these groups in 2013 was 56,940 (UK Renal Registry 17th Annual Report 2014)).

Benefit to these patients will come from research-driven change in policy to improve equity of access to treatment (as described above). Direct communication of results to patient groups will happen as part of ATTOM's Public and Patient Involvement commitment.

Outputs:

When processing of the linked ATTOM-HES data has been completed, the ATTOM study will have analysed variations in hospital resource use and outcomes associated with health literacy, socioeconomic status and comorbidity. Without linked data from NHS Digital these analyses would not be possible.The target date for completion of the work is August 2020. As specified in the ATTOM study protocol, all published output will be open-access (available without charge to the public). All outputs and publications contain only aggregated data with small numbers suppressed in line with the HES Analysis Guide.

Dissemination of results will be as follows:

1) The results of these analyses will form part of planned academic publications in nephrology and public health journals, and presentations at national/international academic meetings (nephrology, public health). This will allow dissemination of the results of these analyses to clinicians and policymakers in nephrology communities worldwide, with subsequent influence on policy.

2) Because the analysis concerns UK patients, the results will be of direct relevance to UK NHS policy. Analyses using ATTOM data have shown that people with low health literacy have reduced access to kidney transplantation, and that this effect is likely to promote socioeconomic inequity in transplant access. Interventions to support people with low health literacy therefore have potential to reduce this inequity and improve outcomes, but have not yet been developed. NHSBT aim to apply for research funding to develop and test such a complex intervention. The proposed HES analysis will provide further evidence in support of this application.

In other healthcare settings (eg: USA nephrology, UK and USA non-nephrology medicine), low health literacy has been associated with increased non-routine healthcare use, but reduced use of preventative healthcare. The suggested analysis of HES data is expected to identify differences in patterns of healthcare use among those with low health literacy- most likely higher expenditure and more use of emergency care. These findings would support interventions to ameliorate the effects of low health literacy in the UK Chronic Kidney Disease population. This analysis will contribute to the development and of a complex intervention as described above.

3) The NIHR-funded ATTOM study has established routes for dissemination of results which include:
a) Presentation at the annual NHS Blood and Transplant Renal Transplant Services Meeting (which invites transplant lead clinicians UK-wide)
b) Stakeholder meetings (which invite clinical leads from UK renal units)
Patient/public representation is required by the NIHR at ATTOM meetings.

Processing:

1) NHSBT will create a copy of the ATTOM dataset and assign a unique person ID not present in the master ATTOM dataset.
2) NHSBT will send NHS Digital the NHS Numbers, DoBs and unique IDs
3) NHSBT will destroy the NHS Numbers, DoBs and any other identifiers except the unique ID in the copy ATTOM
4) NHS Digital will provide pseudonymised HES data with the unique ID enabling linkage with the copy ATTOM dataset but not with the master dataset. NHSBT will not attempt to re-link or re-identify individuals to the data received from NHS Digital
5) All record-level data from the returned dataset will be stored only on the NHS Blood and Transplant(NHSBT) server in a directory with permissions specific to the research team within NHSBT. No data will be accessed by anyone outside of NHS BT.
6) Data will be transferred to statistical packages within the NHSBT server to allow data analysis.
7) Aggregated data with small numbers suppressed in line with the HES analysis guide will be used in draft reports and publications. This data will be made available to the editing team within the ATTOM group. These members are from several institutions listed in the ATTOM protocol.
8) HES ID will be provided to the applicant through this agreement to allow for any future ONS linkage.

Any data used in these draft reports and publications referred to above will be used aggregated with small numbers suppressed in line with the HES Analysis Guidelines.

Data analysis will test the following hypotheses:
a) Healthcare utilisation (admission rate, hospital bed days, HRG tariff remuneration) and patient outcomes (survival from the start of RRT, from transplantation, hospital associated mortality) vary by patient health literacy (defined by responses to the Single Item Literacy Screener), individual-level markers of socioeconomic status and comorbidity in patients from the ATTOM cohort.
b) Comorbidity data derived from diagnoses and procedural information recorded by admissions (prior to the time point of interest) by HES is equal in quality and scope to data collected in the ATTOM study by researchers - this may inform the use of HES data in future observational cohort studies.
No data will be used for commercial purposes, provided in any form to any third party (except when published as aggregate data) or used for marketing of any kind.

All outputs and publications contain only aggregated data with small numbers suppressed in line with the HES Analysis Guide.

No ONS data will flow under this agreement. A future amendment will be required to seek approval for the ONS data to flow to NHSBT.

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).

MR639 - NHS Blood and Transplant - Data Validation — DARS-NIC-147815-X5CHM

Opt outs honoured: Y (Excuses: Does not include the flow of confidential data)

Legal basis: Section 251 approval is in place for the flow of identifiable data, Other-The data was disseminated with support under the Health and Social Care Act 2001 section 60 to process the data without informed consent. This legislation is no longer active and NHS Blood and Transplant is required to confirm how future processing of the data will comply with the common law duty of confidentiality.

Purposes: No (Agency/Public Body)

Sensitive: Sensitive

When:DSA runs 2019-04 – 2020-03 2017.06 — 2017.05.

Access method: Ongoing, One-Off

Data-controller type: NHS BLOOD AND TRANSPLANT (NHSBT)

Sublicensing allowed: No

Datasets:

  1. MRIS - Cause of Death Report
  2. MRIS - Flagging Current Status Report
  3. MRIS - Cohort Event Notification Report
  4. MRIS - Scottish NHS / Registration
  5. MRIS - Members and Postings Report

Type of data: Identifiable

Objectives:

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

Yielded Benefits:

Mortality data was supplied to NHS Blood and Transplant by the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to as "MR639 - NHS Blood and Transplant - Data Validation 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 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. In any future application, the applicant will be required to provide details of the actual benefits that have been realised as part of this study.

Expected Benefits:

Mortality data was supplied to NHS Blood and Transplant by the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to as "MR639 - NHS Blood and Transplant - Data Validation

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 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.

In any future application, the applicant will be required to provide details of the benefits that will be achieved as a result of this study.

Outputs:

Mortality data was supplied to NHS Blood and Transplant by the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to as "MR639 - NHS Blood and Transplant - Data Validation

This Data Sharing Agreement permits the retention of the data for an interim period but no other processing of the data is permitted. No further outputs of the data are permitted to be created under this version of the agreement.

No new outputs will be produced under this Data Sharing Agreement.

In any future application, the applicant will be required to provide details of the outputs that were produced and disseminated by the study as well as details of any future outputs planned.

Processing:

Mortality data was supplied to NHS Blood and Transplant by the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to as "MR639 - NHS Blood and Transplant - Data Validation. Under this Agreement, the data may be securely stored but not otherwise processed. No new data will be provided by NHS Digital under this Agreement.

The study data, including data provided by NHS Digital under previous agreements, are currently held by NHS Blood and Transplant. Under this interim extension all devices containing data will be securely locked away in a locked cabinet at the NHS Blood and Transplant storage address specified in this version of the Agreement.

The following provides background on the processing activities undertaken for the original study:

Identifiable data was shared with ONS to carry out the linkage between the study data and civil registration data. Participants records were ‘flagged’ with the Office for National Statistics (ONS). ONS notified the study team at NHS Blood and Transplant of participants’ deaths (date and cause) and cancer events when they occurred. The ‘flagging for long-term follow up’ service transferred from ONS to the HSCIC in 2008. Data was last supplied in January 2018.

Outcomes of potential recipients of a kidney transplant suspended from the National Waiting List — DARS-NIC-338242-C8Z8M

Opt outs honoured: Y (Excuses: Consent (Reasonable Expectation))

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), Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 – s261(2)(b)(ii)

Purposes: No (Agency/Public Body)

Sensitive: Non Sensitive, and Sensitive, and Non-Sensitive

When:DSA runs 2017-06 – 2020-05 2016.12 — 2017.02.

Access method: One-Off

Data-controller type: NHS BLOOD AND TRANSPLANT (NHSBT)

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Admitted Patient Care
  2. Office for National Statistics Mortality Data
  3. Civil Registration (Deaths) - Secondary Care Cut
  4. HES:Civil Registration (Deaths) bridge
  5. Civil Registrations of Death - Secondary Care Cut
  6. Hospital Episode Statistics Admitted Patient Care (HES APC)

Type of data: Anonymised - ICO Code Compliant

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.

Yielded Benefits:

Expected 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