NHS Digital Data Release Register - reformatted

University Hospitals Birmingham NHS Foundation Trust projects

• Epidemiology of Cancer after solid Organ Transplantation - EPCOT study ( ODR_2014_244 )
• COVID-19 vaccination and disease and the risks of events and complications including major venous and arterial vascular events
• UHB SHMI Data Application
• Benchmarking Service to NHS organisations
• Epidemiology of Cancer after solid Organ Transplantation – EPCOT study
• Long-term Follow Up of Patients in the Birmingham and Lambeth Liver Evaluation Strategies (BALLETS) Study
• Baby Biome Study
• Linking and Evaluation of SABR CTE Patients

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

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🚩 University Hospitals Birmingham NHS Foundation Trust was sent multiple files from the same dataset, in the same month, both with optouts respected and with optouts ignored. University Hospitals Birmingham NHS Foundation Trust 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.

Epidemiology of Cancer after solid Organ Transplantation - EPCOT study ( ODR_2014_244 ) — DARS-NIC-656749-G8K4G

Type of data: information not disclosed for TRE projects

Opt outs honoured: Anonymised - ICO Code Compliant (Section 251 NHS Act 2006)

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

Purposes: No (NHS Trust)

Sensitive: Sensitive

When:DSA runs 2023-07-25 — 2023-10-24

Access method: One-Off

Data-controller type: UNIVERSITY HOSPITALS BIRMINGHAM NHS FOUNDATION TRUST

Sublicensing allowed: No

Datasets:

1. NDRS Cancer Registrations
2. NDRS National Radiotherapy Dataset (RTDS)
3. NDRS Systemic Anti-Cancer Therapy Dataset (SACT)

Objectives:

University Hospitals Birmingham NHS Foundation Trust (UHB) requires access to NHS England data for the purpose of the following research project: Epidemiology of Cancer After Solid Organ Transplant (EpCOT) study.

The following is a summary of the aims of the research project provided by UHB.

Cancer is a major cause of morbidity and has become the leading cause of death after solid organ transplantation.
There is a shortage of research exploring cancer epidemiology after solid organ transplantation in the UK. As a result, there are no guidelines to advise transplant clinicians about post-transplantation cancer and this may impact upon clinical care. This is especially important as outcomes of cancer post-transplantation may differ from the
general population.

Data regarding transplantation, cancer, hospital episodes and death is currently routinely collected as part of mandatory data collection for different registries, but these records are not linked to each other. This means it is impossible to get an integrated insight into cancer epidemiology after solid organ transplantation. Clinicians therefore do not know why post- transplant cancer risk is different for different recipients, what morbidity is associated with posttransplant cancer, how outcomes differ for post-transplant cancer versus the general population.

The main objective for the EpCOT project is to link data sets which already exist in isolation to create an integrated data set that can explore post- transplant cancer epidemiology and help answer some of these questions.

The following NHS England data will be accessed:
- Hospital Episode Statistics (HES) (requested in application DARS-NIC-77142)
- Admitted Patient Care (APC)
- Outpatients (OP)
- Civil Registration Mortality (requested in application DARS-NIC-77142)
- NDRS Cancer Registry (requested in application DARS-NIC-656749)
- NDRS Radiotherapy dataset (RTDS) (requested in application DARS-NIC-656749)
- NDRS Systemic Anti-Cancer Therapy Dataset (SACT) (requested in application DARS-NIC-656749)

The data requested are required for the analysis to obtain the outcomes for the aims of the study, including; comparing of observed and expected risks of specific causes of death, comparing of observed and expected risks of specific cancer types post-transplantation and estimating risk of morbidity requiring hospitalisation both generally and that associated with the development of post-transplantation cancer.

The level of the data will be pseudonymised.

The data will be minimised as follows:
- Limited to data for a study cohort of approximately 85,000 transplant patients. Identified from the UK Transplant Registry (UKTR) who met the inclusion criteria (individuals who have received a solid organ transplant (e.g. kidney, liver, heart, lung, pancreas, small bowel) between 01/01/1985 and 31/12/2015) which UKTR provided to NHS England in the previous iteration of this agreement.
- Limited to data between 1997/98 (where available) and 2018/19 for HES data and latest available (expected 2023) for Civil Registration Mortality.

University Hospitals Birmingham NHS Foundation Trust (UHB) is the data controller and is 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.

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 generalisable and publicly available information to inform future decisions over patients treatments or care.

The funding is provided by the Wellcome Institutional Strategic Support Fund through the University of Birmingham. The funding is specifically for the study described. Funding is in place with no time limit.
University of Birmingham (UoB) is the data processor acting under the instructions of University Hospitals Birmingham NHS Foundation Trust. UoB's role is limited to processing the data on behalf of the Trust.
The funders will have no ability to suppress or otherwise limit the publication of findings.

Data may be accessed by Postgraduate students affiliated with UoB. Any student working with the data held under this Agreement must have completed mandatory data protection and confidentiality training and are subject to UoB's policies on data protection and confidentiality. Any students accessing the data will do so under the supervision of an employee of UoB with authorised access to data. UoB would be responsible and liable for any
work carried out by students. These students would only work on the data for the purposes described in this Agreement. Any education benefit gained from carrying out this work would be an associated benefit and would not be the primary reason for the research being conducted nor the primary reason for their involvement.

A Public and Patient Information and engagement group was consulted regarding the collection of the data for the purposes described above. The EpCOT project was originally discussed with Patient Advisory Boards within NHS Blood & Transplant and with the UHB PPI group which included transplant patients.

Yielded Benefits:

No yielded benefits have been produced as yet, as none of the previous data disseminated was downloaded or processed, due to insufficient information being provided (Civil Registration of Deaths) within the DARS BAU application. This did not provide the relevant data required to deliver the study outcomes. Updated data was disseminated within the DARS BAU application.

Expected Benefits:

The findings of this research study are expected to contribute to evidence-based decision-making for policymakers, local decision-makers such as doctors, and patients to inform best practice to improve the care, treatment and experience of health care users relevant to the subject matter of the study.

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 or conditions.
- 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).

This project has the potential to directly impact upon the care delivered to solid organ transplant recipients in relation to one of the most common and feared immunosuppression-related complications. The dissemination of outcomes for EpCOT may directly influence the development of Standards of Care guidelines to aid transplant clinicians in the delivery of care and may aid counselling for solid organ transplant candidates for their actual risk of post-transplant cancers.

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 benefits may lead to the development of Standards of Care guidelines to improve the delivery of care for solid organ transplant recipients. This may have an impact upon the approximate 4,000 incident solid organ transplant recipients performed annually in the UK but more importantly upon the approximate 45-50,000 prevalent solid organ transplant recipients alive in the UK at the current moment in time. The immediate benefit of the study may be, improved counselling for solid organ transplant candidates by transplant doctors in advance of their transplant surgery, using the evidence for what the likely risk of posttransplant cancer may be. This may better inform patients prior to transplantation, to help them make an informed decision about risk versus benefit, and also raise awareness for transplant doctors to monitor posttransplant care appropriately. With the development of Standards of Care guidelines, the study aims to bring uniformity and best practice evidence to the UK transplant community in view of the current lack of evidence, to guide clinical management and decision-making.

Outputs:

The expected outputs of the processing will be:
• Submissions to peer reviewed journals (e.g., New England Journal of Medicine, The Lancet, JAMA (Journal of the American Medical Association), JAMA Oncology, The BMJ (British Medical Journal), The BMJ Oncology, American Journal of Transplantation, Transplantation, etc.)
• Presentations to transplant webinars (open to professionals and transplant patients)
• Presentations at both national and international transplant conferences (e.g., British Transplantation Society congress, European Society for Organ Transplantation, American Transplant Congress.)

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 datasets from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:
• Journals
• Webinars open to transplant professionals and patients.
• Social media
• Co-hosted events with professional societies

The target date for production and dissemination of the outputs is 2025.

Processing:

No data will flow to NHS England for the purposes of this Agreement.

In a previous iteration of this agreement, UKTR and Public Health England (NCRAS - this service is now managed by NHS England) transferred data to NHS England. The data consisted of identifying details (specifically NHS Number, Date of Birth, Postcode, Gender and a unique person ID).

NHS England generated a common patient identifier (a random unique large integer) for all individuals in the underlying cohort from UKTR - hereby referred to as CPID. NHS England identified and linked those patients who were common to both cohorts. NHS England returned the identifying details provided, along with the CPID back to NCRAS and UKTR respectively.

NHS England will link the UKTR cohort to the relevant records from HES APC, OP and Mortality datasets, along with the CPID, and provide to UoB. The data will contain no direct identifying data items. The data will be pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the recipient.

NCRAS at Public Health England linked the UKTR cohort to the relevant records from Cancer Reg, SACT and RTDS datasets, along with the CPID, and provide to UoB. The data contained no direct identifying data items. The data was pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the recipient.

The data will not be transferred to any other location.

The data will be stored on servers at the University of Birmingham (UoB).

The data will be accessed onsite at the premises of the University of Birmingham (UoB) and the data will also be accessed by authorised personnel via remote access. The data will remain on the servers at UoB at all times.

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

The data will not leave England/Wales at any time.

Access is restricted to employees or agents of the University of Birmingham who have authorisation from the Chief Investigator at University Hospitals Birmingham NHS Trust.

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

NCRAS data sets will be linked to data sets disseminated under BAU DARS-NIC-77142 and NHS Blood and Transplant (NHSBT).

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

Researchers from the University of Birmingham will process the data for the purposes described above.

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COVID-19 vaccination and disease and the risks of events and complications including major venous and arterial vascular events — DARS-NIC-577815-R9L1J

Type of data: information not disclosed for TRE projects

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

Legal basis: Health and Social Care Act 2012 – s261(7)

Purposes: No (NHS Trust)

Sensitive: Sensitive

When:DSA runs 2022-11-21 — 2023-11-20

Access method: Ongoing

Data-controller type: UNIVERSITY HOSPITALS BIRMINGHAM NHS FOUNDATION TRUST

Sublicensing allowed: Yes

Datasets:

1. COVID-19 Vaccination Adverse Reactions
2. COVID-19 Vaccination Status

Objectives:

The main objective for processing data for this data access request is to support vaccine safety and vaccine effectiveness research.

BACKGROUND
There is controversy and public concern about the extent of significant adverse events after COVID-19 vaccination. Overwhelmingly, vaccination is important to the general health of the population and to ensure as a society we can recover from the effects of the pandemic. However, there remains a critical need to understand which groups might be more at risk of vaccine-associated adverse events, and which vaccines might be most likely to be associated with these adverse events. Reports in particular of adverse events relating to blood clotting, and an increase in the rare events of blood clotting in the veins in unusual places or low levels of platelet counts.

This agreement is led by University Hospitals Birmingham NHS Foundation Trust (UHB) via PopulatION systEms for acutE caRe (PIONEER) Data Hub and is part of a larger project led by Health Data Research UK (HDR UK). The larger National Core Study has commissioned work from PIONEER, but also from: Barts Health NHS Trust/Imperial College London - they are the Data Controllers for patients in their London locality; Combined Intelligence for Population Health Action (CIPHA) – they are the Data Controller for patients in their North West locality. The British Heart Foundation (BHF) Data Science Centre are providing analytical support to the study. The additional Data Controllers for the larger National Core Study are mentioned and explained in this section for completeness in this agreement. However, only UHB via PIONEER will be Data Controller for the data applied for in this agreement. Furthermore, no data will be linked across the regions participating in the larger National Core Study, but aggregate summaries (with small numbers suppressed) will be produced across the regions to provide a national report.

UHB is already the data controller of the PIONEER data and will also be the data controller of the data following the linkage of Vaccination Status and Vaccination Adverse Reaction Data for the UHB cohort of patients (see also further below). The concept here is that the dataset, which UHB already holds for their patients for research purposes under the PIONEER health research database (which has obtained favourable ethical opinion, as well as Confidentiality Advisory Group (CAG) approval), is expanded to include Vaccination Status and Vaccine Adverse Reaction Status which is hoped to greatly benefit further Covid research.

The data obtained under this agreement is hoped to provide information about adverse events for the Birmingham population, who have attended UHB Emergency Department or been admitted to one of the UHB hospital sites. Staff employed at UHB will work on this data, and identified analysts from other organisations may work on an anonymised version of the data to supplement expertise via a sublicence application through PIONEER. Any external parties would follow the CAG and Research Ethics Committee (REC) approved PIONEER processes as defined in the protocol on data access. All requests for licensed data will be reviewed against the principles of the ‘Five Safes’ by the Data Trust Committee (members of the public), the PIONEER Management team and the PIONEER Data Controller (UHB). The Five Safes framework is a set of principles to provide safe research access to data. The framework has become best practice in data protection whilst fulfilling the demands of open science and transparency. Safe data (data is treated to protect any confidentiality concerns), Safe projects (research projects are approved for the public good), Safe people (researchers are trained and authorised to use data safely, Safe settings (a secure environment prevents unauthorised use) and Safe outputs (screened and approved outputs that are non-disclosive).

Subject to approval, the vaccine data will be linked with UHB data in the PIONEER database. The sub-licence will be applicable, due to the addition of the NHS Digital Vaccine data, and for the avoidance of doubt, only relates to the data being requested in this agreement, all other PIONEER data is a direct licence application via UHB via the existing established processes. The sub-license for the NHS Digital data (the CV19 vaccine data and the PIONEER data) will be as per the NHS Digital terms.

The aim of the project is to explore the added value of enabling regional, acute care admissions and proxy data flows linked to key data sets such as Vaccination Status to enable surveillance and research on the COVID-19 vaccination programme – specifically to evaluate the safety and effectiveness of the vaccination programme and answer key questions of clinical, regulatory and policy importance, including the incidence of rare adverse events such vaccine-induced immune thrombocytopenia and thrombosis (VITT). Current national data feeds (e.g Hospital Episode Statistics (HES) are limited by being dated, incomplete or lacking sufficient diagnostic coding granularity. Recent analyses of national data to determine the association of COVID-19 vaccines with VITT events have confirmed limitations in these analyses due to time lag and lack of linked laboratory data flows. The critical requirements for a continuous data feed, therefore, are as follows:

* Multi-source linked patient-level data from acute care hospital admissions and vaccinations
* Haematology lab patient-level data feeds (for platelet counts +/- other haematological indices)
* Clear definition of the population covered for the project, so the project can calculate the incidence of adverse effects per head of population.
* Diagnostic coding as close to real time as possible and resolution beyond ICD-10 4 digits (e.g to enable different types of vein thromboses to be identified)

Vaccine data will be requested using NHS number, Date of Birth and postcode, with a study ID. NHS number, Date of Birth and postcode will not be used when data is returned to UHB PIONEER. Only the study ID will be returned with the NHS Digital Vaccine status/adverse reaction data to perform linkage with the PIONEER database.

This research project hope to first address the following research questions:

1) What is the incidence of potential vaccine related complications using data ascertained within hospital compared with the incidence from hospital discharge data only?

2) What is the agreement in ascertainment of vaccine-related complications from within hospital data compared with hospital discharge?

3) What is the average difference in time from vaccination to complication using data from Emergency Departments (ED) or the initial objective was to assess the feasibility of curating a minimum dataset to demonstrate thrombotic complications from Covid vaccination. If successful, the approach may have value in addressing other important policy-related research questions relevant to vaccine safety and effectiveness.

Depending on the answers to the above questions further research questions relating to the safety of vaccines may be worked on.

To date, the project has resulted in a curated data set (acute admissions data coded pre-discharge and laboratory data)– included in PIONEER data Hub (UHB NHS Trust). This agreement is requesting linkage of Vaccination Status and Vaccination Adverse Reaction Data for a cohort of patients provided by UHB. The cohort for linking will be any patients who have had an acute admission, including Emergency Department (ED) attendance to UHB since 8th December 2020 with either a diagnosis of COVID-19 or a symptom relating to a vaccine adverse event. The indicative cohort size is approximately 27,200. The project and planned analyses may a) establish proof of concept, b) support immediate data and connectivity needs of vaccine safety research, and c) explore the added value of enabling such rapid regional data flows with increased granularity (e.g. enhanced ICD coding to distinguish between different types of venous thrombosis or availability of laboratory data for sensitive identification of thrombocytopenia).

The approach taken and phenotypic coding (which are measurable, observable characteristics in admission, laboratory and vaccination coded data to identify thrombotic adverse events) proposed for the analyses were reviewed and validated by an expert group of clinical haematologists (including members of the British Society for Haematology Expert Haematology Panel) and clinical informatics leads at a workshop in early October 2021

In order to meet these requirements, Patient and Public involvement and engagement (PPIE) work was undertaken to obtain feedback and opinion on the project and provide PPIE input to the planned research. The feedback received from the patients was positive and supportive, and a group of the PPIE agreed to be involved in shaping this research and helping to disseminate the results. The team acknowledge that care needs to be taken in how the results are fed back to the public and hopes that the engagement with the PPIE team will help to mitigate some of this risk.

Several themes emerged from the workshop discussions, including:

Public benefit: The perceived benefit to the public meant that attendees were supportive of this project being scaled up across the UK. While it was identified that there are risks to this type of work, there was a strong consensus that the benefits outweigh the risks. This can be assisted by ensuring that appropriate safeguards are in place.

The role of the patient/public: There was discussion around how much responsibility is with patients and the public to be actively seeking to find out about how their data is being used, or if researchers need to be providing that information more freely. It was agreed that involving patients and the public in the development of communications and engagement plans is vital to adequately ensure the public is informed. This helps to build trust and transparency.

Additional data linkages: There were no concerns around additional data linkages from national data sets (such as vaccination status data) being made to routine health data support this project and other urgent pandemic research. There was also broad support for data to be joined up nationally if that was of best interest to research and outcomes. As well, uses of the data beyond COVID-19 were supported, and it was felt that the learnings from COVID-19 should be used in other areas moving forward.

This workshop has demonstrated that there is public support for this work, and this is hoped to support the proposal for a near-real time hospital admissions feed to be scaled up across the UK. One key next step identified from the workshop is to develop a communications plan, with input from patients and the public, to ensure that this work is being communicated transparently to the public. This work is being led centrally by HDR UK. PIONEER/UHB are working on their own supporting PPIE comms and engagement to supplement this and work is continuing. PIONEER/UHB also plan to hold follow-up workshop/engagement after results have been produced. Patient and Public input has been embedded into the structure and culture of PIONEER/UHB. Patient and Public involvement and engagement is not just to disseminate, PIONEER ensure this is throughout the lifecycle.

The outputs (aggregated (with small number suppressed) summaries and reports) from this project is hoped to feed into a proposal for national scale up of enabling such regional data flows, to support the vaccine safety research and potentially other use cases. The project is funded by the Data and Connectivity National Core Study and will run for an approximate duration of 9 months. Data will be required to be retained for 1 year to address any queries or challenges post publication of results, if an extension to this period is required an application will be made to NHS Digital. The data from NHS Digital is vital to enable linkage to Vaccination data to understand the association between post vaccination adverse events and vaccination type. No elements of the work are occurring outside the UK.

LEGAL BASIS
GDPR 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” As a teaching hospital, it facilitates research, which brings this processing in line with our performance of a task in the public interest. Further, as a public benefit organisation, the organisation is unable to rely on an alternative legal basis such as ‘legitimate interests'.

Additionally, as health data is a special category of personal data, UHB will be using GDPR 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-“as the data are required for research purposes in the public interest (meeting the conditions in the DPA 2018 Schedule 1 Part 1 (4) - which GDPR Recital 52(2) determines is an appropriate derogation from the prohibition on processing special categories of personal data) and data processing is subject to appropriate safeguards in accordance with GDPR Article 89(1)). UHB are the sole data controller for PIONEER Data hub, and also the NHS Digital Vaccine Data. UHB are also the only organisation processing the vaccine data unless there is an approved sub-licence. The funders, HDR UK, only act in an advisory role and UHB make the final decisions on the study. The other organisations (CIPHA, Barts, Imperial) are conducting a study on their own data so only act in advisory roles for this project.

The combined data within PIONEER will be different to that held within NHS Digital and will provide a value-added service. The COVID vaccination status and adverse reaction data will be linked to UHB granular electronic health records, including serial physiology and laboratory results which are not available via NHS Digital.

Expected Benefits:

As detailed in Section 5a, it is hoped that the benefits of this work will directly support urgent vaccine safety research, adding to the existing analysis from national linked data sets, to provide additional background rate information on potential VITT events. This may also be important as the Covid-19 vaccine booster programme is rolled out. The outputs of this project may help provide policymakers and NHS managers with more information about the potential increase in patients presenting with adverse vaccine events. As well as highlighting the potential burden in terms of hospital admissions, it may identify whether there is a difference in the presentation of the disease (from non-vaccine related) through analysis of laboratory results and observations (such as heart rate, temperature, blood pressure etc.). The knowledge gained from this research may also be able to stratify which patient groups would benefit from which formulation of vaccine, therefore reducing patient harm. The addition of lab results may be able to identify patients who may be at risk of developing an adverse reaction.

The magnitude of impact for this project is based upon the patient population, for UHB this is 2.2 million and the total population of the study is approximately 9.6 million, so this will provide statistical power and confidence in the findings for National scale-up. The 27,000 (indicative cohort is the numerator and 2.2 million is the denominator for UHB work). The 9.6 million is total population when all the areas in the pilot are combined, so PIONEER are trying to demonstrate this covers a base population for any of the 2.2million patients vaccinated in Birmingham but also the 9.6 million population of the whole core study.

The project may also provide proof of concept and valuable insights into the added value of supplementing currently available national datasets with regional, more rapid and granular data sets. The VITT example will act as the initial use case, however potential applications to other projects requiring timeline data flow – e.g. support for future pandemic/emergencies and rapid identification of patients with emergency conditions for trials.

As stated in Section 5a, this project is part of the National Core Studies supported by the UK Government Chief Scientific Advisor. A letter supporting this work from the UK Government Chief Scientific Advisor states these studies will be crucial parts of the UK response to the next phase of the COVID-19 pandemic. These are truly a four-nation endeavour which ensures the programmes of work are scoped, shaped and delivered in a UK-wide manner. The vision is for data across the UK, including the insights from this study, to feed into National research. The outputs generated may feed into policymaking and operational decisions in all relevant parts of the government across the UK.

The initial outputs may also provide an evidence base to support potential scale up across the UK, and will be presented to senior NHS stakeholders to explore the contribution of mature acute care NHS Trusts to the curated linked dataset, and enablement of secure access to such regional data via the UK wide Trusted Research Environment (TRE) network

This project is exploring a proof of concept – do regional, more rapid acute admissions data flows, linked to e.g. primary care data, vaccination status – enhance currently available national data feeds available (e.g. HES) to provide more detailed and near-real time information on hospital admissions across the UK. The sub-licences are projects looking at acute care presentations where vaccine status/outcome is required. Data that is currently available are only accessible post discharge, some with up to a 6-week time delay, and much of the available data is incomplete. A rapid near-real time hospital admissions data feed could provide vital information for policymakers and researchers, such as the identification of adverse effects from new drugs, like the COVID-19 vaccine. The linked NHS Digital/UHB research database may serve numerous research projects with acute care focus where vaccine data is required. All requests as described for sub-licence are reviewed by our public panel and UHB as data controller before a licence/sub licence is issued. Rapid admissions data could also help to identify COVID-19 cases in hospital by variant type or vaccination status which could help the UK’s policy response to the COVID-19 pandemic.

The benefits discussed (above) could be measured by the impact on policies and publications to contribute to an informed body of knowledge. The actions that lead to the benefits could be carried out by the combined project group, which includes the data controller, funder and third party researchers (subject to access approval via the sub-licence process).

The benefits are intended to be continual, to assist policy makers and researchers with the first outputs planned in Spring 2023 or as soon as possible afterwards.

Processing:

1) UHB NHS Foundation Trust will provide a cohort to NHS Digital – to include the following data items (identifiable data):
a) Study ID
b) NHS number
c) Date of Birth
d) Postcode

2) NHS Digital will then link cohort data to Vaccination Status and Vaccination Adverse Reaction data as a data extract– monthly refreshes of data will be requested. Data will only be requested for patients in the UHB Cohort with acute admissions. The pseudonymised data plus the Study ID only (not the identifiable NHS number, Date of Birth and Postcode data) will then be returned by NHS Digital to UHB Birmingham via Secure Electronic File Transfer (SEFT). The cohort (as stated in Section 5a) will be any patients who have had an acute admission, including an Emergency Department (ED) attendance to UHB since 8th December 2020 with either a diagnosis of COVID-19 or a symptom relating to a vaccine adverse event. The exact number has not been calculated but an estimate can be derived from the number of COVID-19 positive patients who attended or were admitted to UHB since March 2020 through to date – this is approximately 27,200. This study starts in September 2020 so the number will be less than the total reported here.

3) Substantive staff at UHB will then link the data from NHS Digital to UHB internal data. No patients will be re-identified by UHB staff during this linking process. The NHS Digital Vaccine and UHB PIONEER data will be kept in distinct secure folders, to protect NHS Digital data from reidentification. A research dataset using this linked cohort will be created; this dataset will be pseudonymised as per PIONEER protocols. All employees at UHB must undergo annual Information Governance training, which includes passing the subsequent test.

The initial data cohort will be processed and stored on a secure Structured Query Language (SQL) server which sits within the Trust's IT framework and is not available for querying by any unauthorised external parties or tools. Passwords are strictly controlled by UHB IT services, with access permissions for each user administered on the authorisation through an identified senior member of staff at UHB. The physical servers are located on site at UHB in a locked storage room where entry in and out of the rooms is logged and controlled by senior managers.

4) Access to the linked cohort data set for analysis will be via the secure PIONEER Trusted Research Environment (TRE). Data will be stored on a secure, UHB-controlled Microsoft Azure cloud platform in accordance with the 14 UK Cyber Cloud Principles. Applications for access to the curated, linked dataset approved researchers will be via the PIONEER Data Trust Committee - UHB, as Data Controller for PIONEER, has final approval of what data can be shared, and oversees the legal contractual process to ensure this happens safely.

5) Data made available in the PIONEER TRE for secure, approved researcher analysis will be de-identified, with all outputs checked for risk of disclosure or reidentification, to ensure that statistical results of data analysis are non-disclosive.

The legal basis for the data being sent to (or reused by) NHS Digital is National Health Service Act 2006 - s251 - 'Control of patient information'.

UHB use datacentre-as-a-service (co-location) from Crown Hosting, a HM Government-approved datacentre facility, supplied by ARK Data Centres. The server and storage equipment is Trust owned and operated via a privately dedicated link to UHB. IT Services span the local network to the servers and storage hosted at ARK Data Centres, accessing data using the same protocols that UHB do with servers and storage at their other location. Therefore, ARK Data Centres do not access data held under this agreement as they only supply the building. Therefore, any access to the data held under this agreement would be considered a breach of the agreement. This includes granting of access to the database[s] containing the data.

Small number suppression and data disclosure: In order to protect patient confidentiality, when presenting results calculated from patient record level data, outputs will contain only aggregate level data with small numbers suppressed to stop people from identifying themselves and others, and to ensure confidentiality is maintained.

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UHB SHMI Data Application — DARS-NIC-381984-B7X3S

Type of data: information not disclosed for TRE projects

Opt outs honoured: No - data flow is not identifiable, Anonymised - ICO Code Compliant, No (Does not include the flow of confidential data)

Legal basis: 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(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: Yes (NHS Trust)

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

When:DSA runs 2019-10-01 — 2020-10-31 2017.06 — 2024.09.

Access method: Ongoing

Data-controller type: UNIVERSITY HOSPITALS BIRMINGHAM NHS FOUNDATION TRUST

Sublicensing allowed: No

Datasets:

1. Office for National Statistics Mortality Data
2. Summary Hospital-level Mortality Indicator (SHMI) data split by trust and diagnosis group
3. Civil Registration - Deaths
4. Summary Hospital-level Mortality Indicator
5. Summary Hospital-level Mortality Indicator (SHMI)

Objectives:

To produce/analyse statistics using births/deaths data solely to help the NHS perform its duties.

Yielded Benefits:

A range of direct benefits to healthcare have already been delivered during the course of this project. In summary: • NHS Organisations are provided with the information necessary to provide clinical quality and patient safety assurance within their organisation • NHS Organisations are able to identify & interrogate areas of poor performance allowing for evidence based health service management • NHS Organisations are able to identify areas of good performance increasing the understanding of best practice in healthcare To give a specific example: Within the module NHS hospitals are able to quickly identify areas of potential concern relating to mortality within their organisation. Such areas are then investigated further. When appropriate & authorised, the ability to identify a cohort of patients within the organisations and undertake appropriate clinical case note review is invaluable as a part of ensuring good hospital governance. This process is used by hospitals up and down the country. Without using the data sets being requested it would be impossible to deliver this benefit to the NHS. This would have a significant impact on a sizeable number of NHS Hospitals across the country. It is not appropriate to set a target date for this work as the work streams are ongoing and the outputs already form part of a significant number of NHS organisations’ governance assurance processes.

Expected Benefits:

The output of analytics available to NHS organisations using the HED system enable NHS clinicians and managers to increase the understanding of patient outcomes and identify areas for improvement and best practice.
A range of direct benefits to healthcare have already been delivered during the course of this project.
In summary:
• NHS Organisations are provided with the information necessary to provide clinical quality and patient safety assurance within their organisation
• NHS Organisations are able to identify & interrogate areas of poor performance allowing for evidence based health service management
• NHS Organisations are able to identify areas of good performance increasing the understanding of best practice in healthcare
To give a specific example:
Within the module NHS hospitals are able to quickly identify areas of potential concern relating to mortality within their organisation. Such areas are then investigated further. When appropriate & authorised, the ability to identify a cohort of patients within the organisations and undertake appropriate clinical case note review is invaluable as a part of ensuring good hospital governance.
This process is used by hospitals up and down the country. Without using the data sets being requested it would be impossible to deliver this benefit to the NHS. This would have a significant impact on a sizeable number of NHS Hospitals across the country.
It is not appropriate to set a target date for this work as the work streams are ongoing and the outputs already form part of a significant number of NHS organisations’ governance assurance processes.

Outputs:

The sole outputs are analytics designed to assist the NHS in interrogating and deriving understanding from the SHMI indicator. Where appropriate this will include the ability to support the identification of areas of care apt for clinical case note review.
Such outputs are solely provided either via:
• a Module made available within the HED system, or
• aggregate small number censored reports
Within the HED system:
The module can contain aggregate-level information and low-level information. The level of data that can be viewed within a module depends on the access level of the named individual user and which organisation they are working for. As such, access to low-level information, including small numbers, is strictly controlled in line with the access controls outlined in the above section on ‘Processing activities’. This means that Hospitals will only have access to low-level information for their own data.
Outputs are to be used solely for the purpose of assisting the NHS.
Outputs will be used by NHS Clinicians and Managers to:
• Assure and manage clinical quality and patient safety within NHS Organisations
• Identify trends requiring a clinical review of patient pathways. (Hospital-based users with Caldicott approval are able to investigate metrics and ‘drill-down’ to patient-level information, including local patient identifiers, in order to conduct clinical case note review and route cause analysis)
• Increase the understanding of patient outcomes
• Identify potential areas for improvement in clinical quality or operational efficiency either within a Hospital or a local healthcare economy
• Identify areas of best practice either within hospital Trusts or local healthcare economies
All of the above will serve to increase the understanding of patient outcomes in regard to quality, safety, productivity and efficiency benchmarking within the NHS.
It is not appropriate to set a target date for this work as the work streams are ongoing and the outputs already form part of various NHS organisations’ routine reporting and governance assurance processes.

Processing:

Data received from NHS Digital is only processed by authorised University Hospitals Birmingham NHS Foundation Trust (UHB) staff at the specific processing locations listed. No third parties are involved in the processing of the data.
Data received from NHS Digital by UHB is processed in line with a strict protocol and is stored in an access restricted server. This process was recently audited by the HSCIC and found to be robust.
The data received is used to create analyses which are provided to the NHS in order to help it perform its duties. Such analysis is solely provided either: via the online Healthcare Evaluation Data (HED) tool, or via bespoke reports.
The level of data that can be viewed within the system depends on the access level of the named individual user and which organisation they are working for.
No record-level data is provided to any organisation, except where an individual working within an NHS Hospital has the authorisation of their Hospital’s Caldicott Guardian to access patient level information, including sensitive items, for the purposes of conducting clinical review of cases. In such instances a summary (but not all fields present in the raw data) is provided at spell or patient level. For example, the summary will give details of the admission date, method and diagnosis for a patient but not all field relating to the episodes as recorded in the raw data. The data available to users will only relate to patients treated at that Trust.

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Benchmarking Service to NHS organisations — DARS-NIC-06605-X1L9Z

Type of data: information not disclosed for TRE projects

Opt outs honoured: Yes - patient objections upheld, Identifiable, Anonymised - ICO Code Compliant, Yes, No (Section 251, Section 251 NHS Act 2006)

Legal basis: Section 251 approval is in place for the flow of identifiable data, 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, National Health Service Act 2006 - s251 - 'Control of patient information'. , Health and Social Care Act 2012 - s261 - 'Other dissemination of information', Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), 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(7)

Purposes: Yes (NHS Trust)

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

When:DSA runs 2020-12-01 — 2021-11-30 2017.06 — 2024.08.

Access method: Ongoing, One-Off

Data-controller type: UNIVERSITY HOSPITALS BIRMINGHAM NHS FOUNDATION TRUST

Sublicensing allowed: No

Datasets:

1. Hospital Episode Statistics Critical Care
2. Hospital Episode Statistics Outpatients
3. Hospital Episode Statistics Admitted Patient Care
4. Hospital Episode Statistics Accident and Emergency
5. Office for National Statistics Mortality Data (linkable to HES)
6. Bridge file: Hospital Episode Statistics to Mortality Data from the Office of National Statistics
7. Office for National Statistics Mortality Data
8. Civil Registration - Deaths
9. Civil Registration (Deaths) - Secondary Care Cut
10. HES:Civil Registration (Deaths) bridge
11. Emergency Care Data Set (ECDS)
12. HES-ID to MPS-ID HES Accident and Emergency
13. HES-ID to MPS-ID HES Admitted Patient Care
14. HES-ID to MPS-ID HES Outpatients
15. Civil Registrations of Death - Secondary Care Cut
16. Hospital Episode Statistics Accident and Emergency (HES A and E)
17. Hospital Episode Statistics Admitted Patient Care (HES APC)
18. Hospital Episode Statistics Critical Care (HES Critical Care)
19. Hospital Episode Statistics Outpatients (HES OP)

Objectives:

The objective is to provide quality and benchmarking analysis that will enable NHS organisations to deliver better services for patients.
Such analysis is solely provided either: via the online Healthcare Evaluation Data (HED) tool, or via bespoke reports.
This work is commissioned and funded on an ongoing basis by University Hospitals Birmingham NHS FT (UHB) and produced by the Health Informatics Department within the Hospital.
The sole objective of this work it is to support both UHB and other NHS Trusts and commissioners in the ongoing monitoring of clinical quality and organisational effectiveness. This purpose is fulfilled either:
a) Directly, The NHS Trust holds a subscription to use the HED system,
b) Indirectly, Analytics are provided via a non-NHS organizations, i.e. Pricewaterhouse Coopers (PwC), who hold a subscription to use aggregate small number suppressed data within the system only with NHS organisations. UHB has reviewed the NHS standard (ISB 1523) relating to anonymisation and can confirm the systems are compliant with this.
c) through clinically-led bespoke reports based on retrospective, pseudonymised data which if requested are published in peer review journals with small numbers suppressed.

All subscriber organisations are NHS Organisations, there is one non-NHS organisation, i.e. PwC. This organisation works within the healthcare space and has access to the system solely for the purpose of assisting NHS organisations. PwC will only access anonymous data, i.e. aggregate level data with small numbers suppressed in line with HES Analysis guide.

For any future non-NHS subscribers, UHB would seek permission from NHS Digital first and update the DSA accordingly.

NHS organisations are limited to the below list only. The geographical range of these organisations spread across England, and are not concentrated in one region.
• NHS Trusts (between 50 to 75 hospitals)
• Clinical Commissioning Groups (CCG - Less than 10)
• Commissioning Support Units (CSU - Less than 10)
• NHS Improvement
• NHS England
• Quality Observatories (QO - Less than 10)
AQUA – legal basis is under Salford Royal NHS Foundation Trust
NEQOS – legal basis is under Northumberland Tyne and Wear and South Tees NHS Foundation Trusts
• East Midlands Academic Health Sciences Network (AHSN - Less than 10)
Legal basis is under Nottingham University Hospitals NHS Trust
• Non-NHS Organisation - (PwC)

Data is required for all England, for two reasons. Firstly, because when performing analyses, organisations need to be able to select peers based on casemix for more accurate benchmarking to assist with service improvement and these organisations may not be local or regional based. This is true for both UHB and customers of the UHB HED analytical tool. As an example, some HED customers are regional providers of a specific service and others are specialised hospitals which require benchmarking across the whole of the UK. Secondly the current client base for the HED tool is spread across multiple regions of England and therefore require access to their own data.
The years of data required allow for organisations to perform multiple functions, such as being able to demonstrate service improvement over time and visualize trends.

To deliver the stated objective a wide range of healthcare indicators are calculated (over 100) and as such various HES data sets including APC, OP, A&E as well as linked ONS data are required. The objective in having as wide an array of relevant indicators as possible is to give NHS managers and clinicians as complete a picture of hospital performance as possible. Therefore the whole dataset is needed and cannot be compressed to certain fields.

HES-ONS linked data specifically will be used within this work to look at outcomes analysis and form analytical overviews relating to post discharge mortality. Such overviews relate to standardised post discharge mortality monitoring within distinct clinical cohorts and bespoke long term survival monitoring. This work will increase the understanding of complete pathways of care. Any analysis produced using ONS data will not be made available to non-NHS organisations.

Local patient identifier is required within the HED system for direct patient care and there is a legal basis in place under Section 251 of the National Health Service Act 2006. Subscribers will only be able to access this record level Identifiable data for their own patient records (i.e. patients within their Trust).

HED delivers a national benchmarking system that can provide assurance to hospitals they are providing safe and high quality care and treatment, or signpost areas of concern. The HED system enables trusts to easily identify particular patient cohorts that are statistical outliers and warrant further examination. Local patient identifiers are an essential requirement linking areas that require investigation, to hospital records. Without them trusts would not be able to identify their patients and conduct root cause analyses both for internal governance and also to provide assurance to external regulatory authorities across a range of key indicators ie. HSMR, SHMI. Equally, the Secretary of State for Health has ordered a review of avoidable deaths. Ensuring trusts have access to their local patient identifiers through HED enables them to conduct these audits and therefore focuses attention on eradicating mortalities that could have been prevented.

HED does not just include HES and ONS Mortality datasets. Other data sources used within the HED system are HRG National Tariff, VTE Risk Assessment data, NHS England datasets, NRLS patient safety incident reports, PROMS, Safety Thermometer and Infection Control. There is no international data within HED. Furthermore, HES/ONS data is not linked to international data nor is any HES/ONS data used outside of England/Wales.

It is essential for root cause analysis that patients can be considered on a case by case basis. The ability to be able to identify patients via HED and then subsequently interact with other datasets and clinical notes held locally is vital to detect required clinical quality improvements. A specific example of this is via Mortality reviews, where HED directly enables organisations to monitor and manage services so that no avoidable harm comes to patients whilst in their care.

HED specifically empowers healthcare managers and clinicians to measure patient experience and outcomes benchmarked against their peers (both local and nationally) eg. Length of stay, Mortality, Readmissions. This information is not available locally and delivers clinically relevant outcome data and comparative information to clinicians. Access to local patient identifiers is critical to enable health care professionals to audit their data and clinical practice. This review of individual patient outcomes and experience can evidence the care provided is of a good quality and safe, and also provide assurance to trust boards. In addition access to identifiers will also enable clinicians to review and audit deaths attributed to them in national mortality models.

Patient information is only available to organisations who deliver the care. A protocol including Caldicott authorisation form has been reviewed previously by DAAG (DAAG reference: 240412-a) for controlling access to such sensitive items. This established process ensures that access to sensitive items is restricted to authorised hospital trust staff and was found to be robust during a recent HSCIC Audit.

The rationale for allowing PwC access to aggregate level small number suppressed analytics:
As some NHS organisations require additional specialist resource to deliver the benefits of using benchmarking information, therefore subscription to the HED tool is required by PwC as:
1. This enables them to have people equipped to provide immediate support to NHS organisations.
2. Providing them with aggregate level information via the tool is the most efficient way of disseminating information in support of this work – the alternative described directly below would clearly create large inefficiencies.
3. It allows such organisations to be autonomous in undertaking work that requires a level of independence and is beneficial to the NHS e.g. the Keogh review. In this instance PwC were commissioned to complete this review independently of any engagement of NHS Trusts involved. It would therefore have been inappropriate for them to ask the Hospitals for the information required to undertake this review.

The alternative would be for NHS organisations working with the non-NHS organisations to provide data directly to the non-NHS organisations. This arrangement would have the following detrimental effect on the NHS:
1. It would actively be encouraging NHS-organisations to export data at varying levels from the HED system and send it to non-NHS organisations. By non-NHS organisations having direct access UHB are able to monitor which modules are accessed when and by whom. This negates the need for NHS organisations to export isolated aggregate data and email it outside the NHS.
2. It would introduce a longer lead time for projects which would ultimately cost the NHS more.

Yielded Benefits:

As above

Expected Benefits:

To continue to drive clinical service improvements and benefit patient outcome as demonstrated below.

How the data has already benefited health and social care:
The data is used to provide benchmarking information on areas such as:
• Mortality rate
• Emergency readmission rate
• Length of stay
• Day case rate
• New to follow-up outpatient ratios
• A&E clinical quality indicators

The output of analytics available to NHS organisations using the HED system enable NHS clinicians and managers to increase the understanding of patient outcomes and identify areas for improvement and best practice.
A range of direct benefits to healthcare have already been delivered during the course of this project.
In summary:
• NHS Organisations are provided with the information necessary to provide clinical quality and patient safety assurance within their organization
• NHS Organisations are able to identify & interrogate areas of poor performance allowing for evidence based health service management
• NHS Organisations are able to identify areas of good performance increasing the understanding of best practice in healthcare
• Clinicians are supported in undertaking appraisal and revalidation – reflective practice is a vital contributor to ensure high quality care

By utilising the outputs and analytics provided, organisations are able to focus and deliver on the three key principles of Health and Social Care:
• Patients at the centre of the NHS – the analytics as stated above ensure that organisations are empowered to identify areas of poor performance and can put in place measures to rectify this. They are also then able to demonstrate improvement in these areas over time. As the numerous measures bring together patient safety and operational efficiency, organisations can easily identify areas to target to ensure that the care being given is safe, effective and optimal.
• Changing the emphasis of measurement to clinical outcomes – there are multiple modules provided to assist with this focus on clinical outcomes, and the strive to achieve best practice. Organisations are able to ensure they are performing as expected against local and national standards and where necessary identify areas of best practice through benchmarking with peers (locally and nationally).
• Empowering health professionals – The tool enables managers and clinicians to make evidence based decisions i.e. supporting business cases, changing patient pathways. HED provides easily accessible dashboards and analytical modules so healthcare professionals are able to review their specialty and service lines to ensure service delivery and patient outcomes are optimal. The system reports information in a timely, meaningful and relevant fashion to various clinical settings. As the analytics are used by providers and commissioners, the GP is empowered to ensure the services provided are delivery best patient care, again keeping the patient at the centre. Equally the analytics are also used by NHS England and NHS TDA to assist with wider reviews of patient care and outcomes, when reviewing governance and areas of accountability.

To give some specific examples:

Each month a range of modules are produced which allow NHS hospitals to identify areas of potential concern within their organisation. Such areas are then investigated further. When appropriate & authorised, the ability to identify a cohort of patients within the organisation and undertake appropriate clinical case note review is invaluable as a part of ensuring good hospital governance.

• University Hospitals Birmingham (UHB) NHS Foundation Trust’s Clinical Quality Monitoring Group use the HED CUSUM model as a continual assessment of mortality. Diagnosis groups are identified that demonstrate persistent deviation from the expected mortality levels and reach a pre-set trigger point. Consequently, the trust approach to mortality is proactive rather than reactive, and enables UHB to review the deaths and share the outcome with CQC considerably before the official regulatory notification. UHB currently have a HSMR of 100, representing the number of observed deaths is the same as the number of expected deaths.

• George Eliot Hospital NHS Trust have used HED mortality modules to undertake root cause analysis of patients which has ultimately seen them move from special measures to a CQC rating of ‘Good’.

• Royal Liverpool and Broadgreen University Hospital NHS Trust uses HED to report benchmarking and mortality to their Trust Board. A measureable benefit they have observed, and that is echoed in other trusts, is the significant amount of time they have saved with HED automatically producing these reports for them, freeing their time for other hospital priorities.

• Calderdale and Huddersfield have used HED to look at their clinical coding to evidence areas of improvement in data quality and ensure they are not over or under coding compared to local and national peers. The system has provided reassurance to the CHFT Exec Board and Local Commissioning Groups while providing benchmarking insight into coding within different specialty areas.

• HED provides direct intelligent feedback to service areas that can change hospital performance for the better. However, this is not the only tool that will influence behaviour in a hospital so it is difficult to attribute changes solely to HED. As a marker of the sizeable impact it would have were HED not able to provide this information, Derby Teaching Hospitals NHS Foundation Trust, Royal Cornwall Hospital NHS Trust, Bradford Teaching Hospitals NHS Foundation Trust and The Royal Wolverhampton NHS Trust are just a few examples of the many trusts that have contacted HED over the last few months unable to access patient identifier information for case note reviews. Hospitals who are unable to access patient identifier have noticed instantly the impact this missing data is having on their ability to interrogate and improve their trust’s mortality levels.

• Plymouth Hospitals NHS Trust have used HED to generate Service Line Benchmarking packs for clinicians and service managers to help inform decisions about transformation. The packs bring together data on finances, operational efficiency, safety and quality indicators benchmarked against relevant peers. This allows service lines to examine their data and highlight potential financial opportunities. Measureable benefits from this was that the trauma and orthopaedic team were surprised to find 50% of local activity was being carried out by other providers outside of the main NHS teaching hospital. Consequently referral to treatment times were targeted by the orthopaedic team working with radiology to develop a one-stop outpatient service where patients referred by their GPs can have their imaging and initial discussions on one day – and receive a same day decision about whether they are suitable for surgery.

• Sherwood Forest Hospitals NHS Foundation Trust predominantly use HED for market share and benchmarking of length of stay, day case rates, readmissions, DNA rates and new to followup ratios against peers. HED is also used to provide assurances around the HSMR/SHMI and highlight areas of focus to the Mortality Surveillance group. Specific measureable benefits have been the delivery of information to service line meetings and to the business unit. This has been used to set targets, interpret meaningful information and provide context by measuring against local peers and nationally – which the trust had not otherwise been able to do for a number of years. Furthermore, HED delivers the ability for this information to be available to all staff groups – without the reliance on the individual trust’s Information Team.

This key reporting and case note review process is used by hospitals up and down the country, most commonly in the areas of mortality and readmissions management. Without using the HES data it would be impossible to deliver these sorts of benefits to the NHS.

Since 2010 the number of NHS organisations using HED has grown, and retention of customers remains high with only a small percentage of customers who did not renew (<5% non-retention rate). Customers are also signing for lengthy contract periods as they value the insight provided, with the average contract length being for 3 years and with some NHS organisations subscribing for 5 year periods. This high retention rate and the continued investment in the HED system demonstrates the value organisations place on the product and the benefits it brings in a period where organisations are looking to make cost savings and efficiencies.

The role of Non-NHS Organisations in supporting NHS Organisations:
Allowing the named non-NHS organisations to access aggregate level analytics is beneficial to the NHS as it enable the NHS to quickly access additional specialist resource when it is required. This allows the timely delivery of improvements in clinical quality and/or operational efficiency.
Without this option it would be necessary for them to increase or upskill their internal resource. To do so would require longer timescales and prove more costly for the organisation in the long run if there is primarily a short term need.
Some further specific benefits relating to private sector access include:
1. Supporting the Keogh review at various levels in terms of creating the initial data packs for the review and also in undertaking subsequent mortality reviews which ultimately resulted in 13 hospitals being taken off special measures by the CQC.
2. Supporting commissioners across an area to have the evidence necessary to understand how to improve the quality and provision of care across a region.

It is not appropriate to set a target date for this work as the work streams are ongoing and the outputs already form part of a significant number of NHS organisations’ monthly reporting and governance assurance processes.

Outputs:

The sole outputs are benchmarked or standardised healthcare indicators such as measures of mortality, survival, discharge and admission trends, readmissions, length of stay, patient safety etc.

Such outputs are solely provided either via:
• the range of Dashboards and Modules made available within the HED system, or
• aggregate small number censored reports

Within the HED system:
Dashboards will only contain aggregate level information. Modules can contain aggregate level information and low level information. As explained, the level of data that can be viewed within a module depends on the access level of the named individual user and which organisation they are working for. As such, access to low level information, including small numbers, is strictly controlled in line with the access controls outlined in the above section on ‘Processing activities’.
Outputs are to be used solely for the purpose of assisting the NHS.

Outputs will be used by NHS Clinicians and Managers to:
• Assure and manage clinical quality and patient safety within NHS Organisations
• Identify trends requiring a clinical review of patient pathways. (Hospital based users with Caldicott approval are able to investigate nationally standardised metrics and ‘drill-down’ to patient level information, including local patient identifiers, in order to conduct clinical case note review and route cause analysis)
• Increase the understanding of patient outcomes
• Identify potential areas for improvement in clinical quality or operational efficiency either within a Hospital or a local healthcare economy
• Identify areas of best practice either within hospital trusts or local healthcare economies
• Provide consultants with the information necessary for consultant revalidation

All of the above will serve to increase the understanding of patient outcomes in regard to quality, safety, productivity and efficiency benchmarking within the NHS.

As mentioned, aggregate level small number censored analytics produced for the HED tool are being made available to one non NHS organizations, PwC. UHB are working with this subscriber to support NHS organisations. Some examples of the specific outcomes of this access are:
• Aggregate level analytics have been used to undertake due diligence for both Monitor and CQC. A good example being production of the Keogh review information packs. This information was vital to the extensive work undertaken as part of the Keogh review which has culminated in the majority of the hospitals originally identified being taken out of special measures by the CQC.
• A further example is use of aggregate level analytics on elderly care readmissions with a CCG in order to support work helping them to understand how they could reduce avoidable readmissions within their region.

It is not appropriate to set a target date for this work as the work streams are ongoing and the outputs already form part of various NHS organisations’ monthly reporting and governance assurance processes.

Processing:

Data received from NHS Digital is only processed by authorised UHB staff on site at UHB. No third parties are involved in the processing of the data.

Data received from the NHS Digital by UHB is processed in line with a strict protocol and is stored in an access restricted server. This process was audited by NHS Digital and found to be robust.
The data received is used to create a wide range of healthcare indicators which focus in on the quality, safety, productivity and efficiency of healthcare delivery. Such analysis is solely provided either: via the online Healthcare Evaluation Data (HED) tool, or via bespoke reports. Either of which is only provided to UK organisations.

Summary of types of users and access controls in place:
PwC: Access to aggregate level small number suppressed analytics only formed using HES APC, OP or A&E data (but NOT ONS data)
NHS but non-Hospital User: Access to aggregate level small number suppressed analytics only formed using HES APC, OP, A&E and/or ONS linked data.
NHS Hospital User: Access to aggregate level small number suppressed analytics only formed using HES APC, OP, A&E or ONS linked data unless Caldicott authorisation is in place to allow access to low level details and/or sensitive items for their own organisation only.
ONS data access will be limited to subscriber NHS organisations only (in line with current approvals).
UHB have permission to share ONS data with NHS Acute Trusts. This agreement permits UHB to additionally share ONS data with NHS organisations that are Non-Acute Trusts, specifically:
Clinical Commissioning Groups
Commissioning Support Units
NHS Improvement
NHS England

Only aggregate level small number supressed analytics will be provided to the Non-Acute Trusts. These NHS organisations require access to aggregate ONS data as they report on the SHMI mortality model (which uses ONS data to report on numbers of deaths within 30 days of discharge).

The NHS Non-Acute Trusts are responsible for nursing and medical teams across England. HES-ONS linked data specifically will be used to look at outcomes analysis and form analytical overviews relating to post discharge mortality. Such overviews relate to standardised post discharge mortality monitoring within distinct clinical cohorts and bespoke long term survival monitoring. This work will increase the understanding of complete pathways of care. Any analysis produced using ONS data will not be made available to non-NHS organisations. The objective is to provide quality and benchmarking analysis that will enable NHS organisations to deliver better services for patients.


No record level HES or ONS data is provided to any organisation, except where an individual working within an NHS Hospital has the authorisation of their Hospital’s Caldicott Guardian to access patient level information, including sensitive items, for the purposes of conducting clinical review of cases. In such instances a summary (but not all fields present in the raw HES or ONS data) is provided at spell or patient level. For example, the summary will give details of the admission date, method and diagnosis for a patient but not all fields relating to the episodes as recorded in the raw HES data.

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Epidemiology of Cancer after solid Organ Transplantation – EPCOT study — DARS-NIC-77142-Q4D1D

Type of data: information not disclosed for TRE projects

Opt outs honoured: Yes - patient objections upheld, Anonymised - ICO Code Compliant, Yes (Mixture of confidential data flow(s) with support under section 251 NHS Act 2006 and non-confidential data flow(s), Section 251 NHS Act 2006)

Legal basis: Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 – s261(2)(b)(ii), Health and Social Care Act 2012 – s261(2)(a)

Purposes: No (NHS Trust)

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

When:DSA runs 2020-04-27 — 2023-04-26 2021.03 — 2023.06.

Access method: One-Off

Data-controller type: UNIVERSITY HOSPITALS BIRMINGHAM NHS FOUNDATION TRUST

Sublicensing allowed: No

Datasets:

1. Hospital Episode Statistics Admitted Patient Care
2. Hospital Episode Statistics Outpatients
3. Civil Registration - Deaths
4. HES:Civil Registration (Deaths) bridge
5. Civil Registration (Deaths) - Secondary Care Cut
6. Civil Registrations of Death - Secondary Care Cut
7. Hospital Episode Statistics Admitted Patient Care (HES APC)
8. Hospital Episode Statistics Outpatients (HES OP)
9. Civil Registrations of Death

Objectives:

Cancer is a major cause of morbidity and has become the leading cause of death after solid organ transplantation. There is a shortage of research exploring cancer epidemiology after solid organ transplantation in the UK. As a result, there are no guidelines to advise transplant clinicians about post-transplantation cancer and this may impact upon clinical care. This is especially important as the aetiology, pathophysiology and outcomes of cancer post-transplantation may differ from the general population.

The current level of evidence for post-transplant cancer has several limitations. Firstly, the bulk of published evidence comes from transplant cohorts in the United States but this data may not be directly translatable to the United Kingdom. Differences in demographics, immunosuppression regimens and post-transplant practise means transplant outcomes are completely different between the two countries. Previous work has shown cancer epidemiology data is not translatable between kidney transplant cohorts between England and New York State (Jackson-Spence et al. Cancer Medicine 2018). Only two publications have reported cancer epidemiology in the United Kingdom (Collette et al. Am J Transplant 2010; Farrugia et al. Kidney Int 2014). However, both are now outdated in line with significant evolution of delivery of post-transplant care over the last 10-15 years and both fail to integrate multiple registries to obtain a more complete and more integrated pathway of the patient journey.

Data regarding transplantation, cancer, hospital episodes and death is currently routinely collected as part of mandatory data collection for different registries but these records are not linked to each other. This means it is impossible to get an integrated insight into cancer epidemiology after solid organ transplantation. We therefore do not know why post-transplant cancer risk is different for different recipients, what morbidity is associated with post-transplant cancer, how outcomes differ for post-transplant cancer versus the general population among many other unanswered questions. This study is called the Epidemiology of Cancer After Solid Organ Transplantation (EpCOT) study. The main objective for the EpCOT project is to link data sets which already exist in isolation to create an integrated data set that can explore post-transplant cancer epidemiology and help answer some of these. This integrated data set will not be used for any research other than that stated in this Purpose Section.

University Hospitals Birmingham NHS Foundation Trust (UHB) wants to study an anonymised extract of data from University of Birmingham derived from a cohort of transplant patients provided by NHS Blood and Transplant (NHSBT) (all people included in the register as having had a transplant between 1985 and 2015 - circa 85,000 patients) and a cohort of individuals on the National Cancer Registration and Analysis Service (NCRAS) provided by PHE, linked to pseudonymised data from NHS Digital under this DSA to examine cancer incidence, management, and mortality, along with the resource implications. UHB is acting as the sole Data Controller, while the University of Birmingham is the sole Data Processor.

Public Health England and NHS Blood and Transplant (NHSBT) are involved in the wider project as collaborators but are not processing data in any way. They will be providing the cancer and transplant-specific data to NHS Digital for record linkage and will provided the anonymised data to the University of Birmingham with the unique study identifier for the Data Processor to link.

This application is not linked to any other wider project and is the first and only project of its type in the United Kingdom. This project will be using an English cohort of 85,410 patients who have received a solid organ transplant (e.g. kidney, liver, heart, lung, pancreas, small bowel) between 01/01/1985 and 31/12/2015 and who have data stored with the UK Transplant Registry (UKTR) by mandatory requirement cross-referenced with individuals on the National Cancer Registration and Analysis Service (NCRAS) held by PHE. After record linkage with the appropriate national population-based data registries, the EpCOT researchers will be able to distinguish solid organ transplant recipients with a diagnosis of post-transplant cancer versus solid organ transplant recipients who do not develop post-transplant cancer.

Responding to the need for research into post-transplantation cancer, the aim of the study is to improve delivery of care to solid organ transplant patients in the UK who are at risk or currently living with cancer. The following research questions will be investigated:
1. Compare observed and expected risks of specific causes of deaths, in particular cancer-related death, by linking the UKTR with the national death registry to obtain underlying causes of death and determine factors related to increased risk of specific causes of death post-transplantation. General population mortality rates will be used to calculate expected number of deaths from specific causes and identify subgroups of post-transplant patients (e.g. age, sex, transplant centre, organ type, etc.) at excess risk compared with expected.
2. Investigate survival and causes of death after cancer in post-transplant patients versus individuals from the general population who develop similar new onset cancer of the same age, sex, and calendar year of diagnosis.
3. Compare observed and expected risks of specific cancer types post-transplantation by linking the UKTR with the national cancer registry to obtain observed numbers of cancers and determine factors related to increased risk of specific types of cancer. General population cancer incidence rates will be used to calculate expected numbers of cancers of specific type and identify subgroups of post-transplant patients at excess risk of specific cancers compared with expected.
4. Estimate risk of morbidity requiring hospitalisation both generally and that associated with development of post-transplantation cancer by linking the UKTR with Hospital Episode Statistics (HES). Risk of hospital admissions and procedures (e.g. surgery) for specific morbidities will be investigated. We will calculate expected risks for specific conditions requiring hospitalisation, enabling identification of specific subgroups of post-transplant patients at excess risk compared with expected.

DATA REQUESTED
This project will require linkage between four data sets:
1) UK Transplant Registry (UKTR) contains transplant-specific data provided by NHS Blood and Transplant (NHSTB);
2) the National Cancer Registry (from the National Cancer Registration and Analysis Service (NCRAS) provided by Public Health England (PHE));
3) HES APC and OP data for secondary care episodes and procedures (NHS Digital) and
4) Civil Registrations - Deaths data (also NHS Digital). (only a flag indicating that death has occurred and the months from transplantation to death, and cause of death to determine death-specific mortalities).

This data is already in existence for audit, governance and approved research perspectives within individual registries. However, to obtain a complete picture of the transplant patients journey with a diagnosis of cancer, it is important to link up these data sets to ensure all captured information is available. Only patients who match in both UK Transplant Registry and National Cancer Registry will have their data transferred to the Data Processor.

No patient identifiable data is being requested. Data requested is to allow analysis of important epidemiological outcomes only. UHB is requesting the minimum required data to ensure the study outcomes are achieved. UHB has asked for a reduced set of HES data to minimise the amount of information used for the project. They have requested information on mortality but would like only a flag indicating that death has occurred and the months from transplantation to death, and cause of death to determine death-specific mortalities.

This study is funded by a grant from the Wellcome Institutional Strategic Support Fund through the University of Birmingham. The funder has no role in the conduct of this study and is therefore not a Data Controller.

Expected Benefits:

Despite cancer being a major complication after solid organ transplantation, there are no standards of care to guide clinical decision making and this impacts upon the care given to solid organ transplant recipients with or without cancer (as all are at risk due to the need for lifelong immunosuppression). Solid organ transplantation is frequently in the public arena for discussion and will be more so with the move to opt-out organ donation in England and Scotland during 2020. It is important that the advantages of solid organ transplantation for individuals with end-stage organ failure are balanced by increased awareness and education regarding the immunosuppression-related complications of solid organ transplantation.

Cancer is a major cause of morbidity and has become the leading cause of death after solid organ transplantation. It is cited as one of the leading concerns for solid organ transplant recipients themselves. Unfortunately, there is a shortage of research exploring cancer epidemiology after solid organ transplantation in the UK. Much of what we know about cancer management for transplant patients is simply translated from the general population, but this may not be the best model of care for solid organ transplant recipients who have altered risk for cancer due to immunosuppression. The bulk of available data relating to transplant cohorts comes from the United States or Australia/New Zealand and this data may not be translatable to the UK due to different demographics, disease burdens, immunosuppression protocols etc. Therefore, our output will provide clinical evidence for a UK-specific cohort and guide transplant clinicians with better prevention and management techniques.

This project has the potential to directly impact upon the care delivered to solid organ transplant recipients in relation to one of the most common and feared immunosuppression-related complications. The dissemination of data for EpCOT will directly influence the development of Standards of Care guidelines to aid transplant clinicians in the delivery of care and aid counselling for solid organ transplant candidates for their actual risk of post-transplant cancers.

Targeted EpCOT epidemiological studies will aim to understand some of the following unanswered questions related to the epidemiology of cancer after solid organ transplantation that will have direct impact on care for solid organ transplant recipients:

a) Cancer incidence post-transplantation (target 2020)
• How many solid organ transplant patients are living with cancer?
• How do cancer cases differ between different solid organ transplant recipients?
• How do cancer cases differ between transplant and non-transplant patients? Is cancer more aggressive at diagnosis in the context of transplantation?
• What are the risk factors for cancer post-transplantation and are some solid organ transplant recipients at greater risk than others? What is the influence of selected immunosuppresant agents on cancer occurrence?
• Does cancer occurrence differ between national transplant centres (a reflection of differing immunosuppression regimens across transplant centres)?
• What is the risk for cancer occurrence post-transplantation for patients with previous history of cancer? Does that risk differ dependent upon type of cancer?

b) Cancer management post-transplantation (target 2020)
• Does cancer progress faster in transplant recipients versus a matched cohort of non-transplant cancer patients?
• Is management of cancer post-transplantation different in comparison to non-transplant setting?
• What is the impact of cancer on solid organ transplant recipients? How does cancer impact upon morbidity post-transplantation such as hospitalisations, complications, procedures etc?
• What is the influence of selected immunosuppresant agents on cancer progression?

c) Cancer mortality post-transplantation (target 2020)
• Is higher cancer-related mortality post-transplantation due to higher incidence, faster progression or both?
• Which solid organ transplant recipients are at greater risk for death after a diagnosis of cancer?
• How does cancer mortality differ among recipients of different solid organs?

d) Resource implications for cancer post-transplantation (target 2020-2021)
• What transplant-specific screening strategies may be effective to prevent certain types of cancers? For example, longer periods of dialysis pre-kidney transplantation have been identified as a potential risk factor for post-transplantation renal cell cancer – how long is too long on dialysis pre-transplantation before routine screening may be beneficial? Does risk differ between different dialysis modalities pre-transplantation?
• Where should investment be directed to help improve outcomes?
• Is there any variation across the country with treatment and outcomes (patient, allograft and cancer-related)?

Dissemination of these findings will be done professionally (at congresses, invited lectures and high-impact peer-reviewed publications) and through distribution channels through both local (UBH and University of Birmingham) and national organisations (NHS Blood and Transplant, Public Health England, British Transplantation Society) with stakeholder interest in this project.

The benefits will lead to development of Standards of Care guidelines to improve delivery of care for solid organ transplant recipients. This will have an impact upon the approximate 4,000 incident solid organ transplant recipients performed annually in the UK but more importantly upon the approximate 45-50,000 prevalent solid organ transplant recipients alive in the UK at the current moment in time. The immediate benefit of our study will be improved counselling for solid organ transplant candidates by transplant doctors in advance of their transplant surgery using our evidence for what the likely risk of post-transplant cancer will be. This will better inform patients prior to transplantation, to help them make an informed decision about risk versus benefit, and also raise awareness for transplant doctors to monitor post-transplant care appropriately. With development of Standards of Care guidelines, we aim to bring uniformity and best practise evidence to the UK transplant community in view of the current paucity of evidence to guide clinical management and decision making.

Outputs:

The aim of this project is to produce targeted studies looking at the epidemiology of post-transplantation cancer, and this data will be disseminated through presentations at speciality congresses (e.g. British Transplantation Society Annual Congress, European Society for Organ Transplantation) and submitted for publication in leading medical journals. The aim is also to develop Standards of Care guidelines with the Standards Committee of the British Transplantation Society to provide evidence based clinical evidence for direct patient benefit and we have their support and agreement for this. It is also the aim to plan patient-focused dissemination in plain English through various channels of communication for public consumption.

Outputs will only contain aggregate data with small numbers suppressed in line with the NHS Digital HES Analysis Guide.

Both NHS Blood and Transplant and Public Health England (who provide the initial data cohorts on this project) have mechanisms for dissemination of information to both professional and general population and the EpCOT Researchers will use these to share the results from EpCOT widely. We also aim to do similar research presentation at Research Open Days at both University Hospitals Birmingham and the University of Birmingham. Summary research findings are actively disseminated via social media channels (e.g. @AdnanSharif1979; @UHBResearch; @ImmunologyUoB) and also for the respective partners(@NHSBT_RD; @PHE_uk). We are also planning to work on evidence-based guidelines with the British Transplantation Society and these will be made freely available to the community at their website (https://bts.org.uk/guidelines-standards/). The plan is to produce significant research output for presentation as free communications and submission of manuscripts for peer-reviewed publication consideration.

The investigator team has a proven track record of presenting scientific abstract work at meetings and congresses, invited lectures and high-impact peer-reviewed publications to ensure the communication of our research output is provided to the largest, and most diverse, audience possible. This will be undertaken both professionally but also locally (UHB and University of Birmingham) and national organisations (NHS Blood and Transplant, Public Health England, British Transplantation Society) with stakeholder interest in this project.

The data will not be shared with any organisation outside the Data Processor so there will be no exploitation of outputs for development of treatment algorithms. The results and output will be used to guide the development of Standards of Care guidelines for transplant clinicians to utilise through working with the Standards Committee of the British Transplantation Society.
These dissemination roles will be facilitated by the Data Controller and Data Processor, with the research team in charge of research facilitation. Project partners will be encouraged to disseminate their involvement through social media channels. The dissemination of the Standards of Care guidelines that will be developed will be facilitated through the British Transplantation Society.

The aim is for dissemination of data in congresses in 2020 and 2021, with submission of manuscripts for peer-reviewed publications planned for 2020. Development of Standards of Care guidelines will occur from 2021 once the preliminary epidemiological studies have been undertaken and presented. Social media dissemination at various important stages of the project will be undertaken by the lead applicant (@AdnanSharif1979) with relevant organisation and partners tagged.

Processing:

NCRAS (part of PHE) and UKTR (part of NHSBT) will supply NHS Digital with a list of identifying details for their respective cohorts [NHS Number, Date of Birth, Postcode, Pseudonymised Study ID] thus allowing NHS Digital to identify and link those patients who are common to both data sets. NHS Digital will then generate a random unique identifier (large integer) for each linked patient and then return the identifying details originally provided, along with this common identifier, back to NCRAS and UKTR respectively. NCRAS and UKTR will then extract the relevant clinical/health data only relating to the target 85,410 solid organ transplant recipients between the stated time period of 1985-2016. All three organisations will then independently send to the Data Processor their agreed respective data set (cancer data (NCRAS), transplant data (UKTR); HES and mortality data (NHS Digital) as pseudo-anonymised data with the common patient identifier provided by NHS Digital to allow record linkage by the Data Processor.

Data linkage will be conducted by the NHS Digital who will facilitate linkage of non-identifiable patient data between various data resources:
1. UK Transplant Registry [provided by NHSBT] will provide a cohort of approximately 85,000 transplant patients. This cohort is static, being made up on patients who underwent transplants between 1985 and 2015.
The Information Governance teams at both UHB and UKTR are content there is no need for a DPA in this setting (EpCOT already receive data files from UKTR based on individual requests).

2. National Cancer Registration and Analysis Service (NCRAS) [provided by PHE]
PHE will transfer direct identifiers to NHS Digital [NHSNUMBER, BIRTHDATEBEST, POSTCODE, PATIENTID (project specific pseudo ID)] to enable linkage to data held by the UK Transplant Registry.
- Cancer site: All cancer sites and morphologies (C00x – C097x and D00 – D48)
- Geography: resident in England
- Diagnosis dates: 1 January 1985 through 31 December 2017.
- Male and female patients aged 0 – 100
- Where there is an unambiguous match, NHS Digital will return a list of pseudonymised patient IDs to PHE.

3. HES data sets (NHS Digital)
HES APC Annual Refresh between 1997/98 to 2018/19.
HES OP Annual Refresh between start of data set (2003/04) to 2018/19.

4. Civil Registration - Deaths Secondary Care cut data (NHS Digital) - a flag on the resultant cohort indicating that death (any death) has occurred (month and year of death) and cause of death to determine death-specific mortalities.
Start of data set to end of 2018/19.

Data linkage methodology
- The linkage methodology will involve UK Transplant Registry and NCRAS sending to NHS Digital only a list of identifying details for their respective cohorts.
- NHS Digital will link the UK Transplant Registry and NCRAS cohorts and determine which patients are common in both data sets.
- NHS Digital would then provide a list of pseudonymous IDs of patients common in both data sets to UK Transplant Registry and NCRAS respectively so that they can extract the clinical/health data from their data sets respectively.
- NHS Digital to link cohorts to HES and Civil Registration - Deaths [a flag indicating that death has occurred and the months from transplantation to death, and cause of death to determine death-specific mortality] and extract records.
- NHS Digital to supply pseudo-records to University of Birmingham with the common patient identifier to facilitate linkage.

There will be no need, requirement or possibility to re-identify individuals after record linkage by the Data Processor. The data sent to the Data Processor will be stored on a separate array of disks and accessed on a mapped drive as part of the University of Birmingham campus network. Access to this mapped drive will be limited to the named University researchers who can only access the University of Birmingham campus network with a personalised username/password combination. The personal computers used to access the data will have additional virus checking/data security software installed (Malwarebytes). The separate array of disks will reside in a controlled environment with access only by accredited University IT staff. The data from this disk array will be backed up under a separate storage policy which once deleted will make the data unavailable for restore.

The linkage, processing and analysis of the data from UKTR, NCRAS and NHS Digital will only be carried out the specified researchers within the University of Birmingham as the Data Processor who are appropriately trained in data protection and confidentiality. There will be no attempt made to link any data requested under this application to any held under other Data Sharing Agreements. This database of the pseudonymised data will be accessible only to named personnel within the project and will be kept in auditable documents. In addition, analysts fulfilling database administrator role (who are substantive members of the University of Birmingham) will also have access to the database but undertake no processing. At the end of the project the data will be destroyed in line with strict policies and procedures on the destruction of data.

No record level information will leave the Data Processor or aggregated data without small number suppression in line with the NHS Digital HES Analysis Guide.

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Long-term Follow Up of Patients in the Birmingham and Lambeth Liver Evaluation Strategies (BALLETS) Study — DARS-NIC-386178-Y2S6V

Type of data: information not disclosed for TRE projects

Opt outs honoured: Identifiable, Anonymised - ICO Code Compliant, Yes (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'.

Purposes: No (NHS Trust)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2022-10-31 — 2024-10-30 2023.02 — 2023.04.

Access method: One-Off

Data-controller type: UNIVERSITY OF BIRMINGHAM

Sublicensing allowed: No

Datasets:

1. Civil Registration - Deaths
2. Hospital Episode Statistics Admitted Patient Care
3. Hospital Episode Statistics Outpatients
4. Civil Registrations of Death
5. Hospital Episode Statistics Admitted Patient Care (HES APC)
6. Hospital Episode Statistics Outpatients (HES OP)

Yielded Benefits:

The previous study used data that was collected specifically for the study and did not link to any NHS Digital data.

Expected Benefits:

As outlined previously, the study team believe that this research is of importance to the general public as NAFLD is a condition thought to affect at least one in four adults in the UK. They believe it is important that these patients, when first identified in primary care are given realistic and reliable information about their future risk of severe liver disease and survival. When fully informed about the potential risks patients may be more proactive in their treatment or monitoring plans. They hope that results of this research will provide the evidence to determine whether routine assessments of the patient’s liver well-being is justified. As a secondary benefit of this work the study team to hope be able to provide reliable information about the use of hospital liver services that patients with NAFLD will have, allowing hospitals to more accurately estimate the availability of these services if the prevalence of NAFLD continues to rise.

The study team hope the findings of the study will be of great value to current health and social care services. Since the BALLETS patients underwent a 'battery' of tests both when they entered the study and again after two years, the study team are able to characterise patients in detail, and are in a unique position to provide information that they hope be of great interest to patients and the public.

This is a standalone project which will not be used as part of post-graduate student’s studies.

Outputs:

UHB will assist UoB on a paper including the aggregated, small number supressed (in line with the HES analysis guide) results of the data analysis with a view to submitting to peer-reviewed journals. The study team feel that the results of this study will be a good fit for the BMJ, and that is where they aim to first submit. Some of the results may be presented at local meetings.

Local meetings include regular seminar series organised and run by both the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust. These include:
• Monthly seminar series organised by Institute of Applied Health Research, University of Birmingham. These seminars are available to staff in the University of Birmingham and advertised through University of Birmingham communications channels.
• Seminar series organised by University Hospitals Birmingham NHS Foundation Trust. These health seminars are open to members of the University Hospitals Birmingham NHS Foundation Trust (patients, carers and staff) and are free to attend.
• Seminars at the Institute of Translational Medicine. Seminars@ITM are cross-discipline seminars designed to showcase the research conducted across the Birmingham Health Partners campus (University Hospitals Birmingham NHS Foundation Trust, University of Birmingham, Birmingham Women’s and Children’s NHS Foundation Trust)

This agreement for this current study on the BALLETS project is a standalone follow-up to the original BALLETS study. The study team have involved members of the public from the outset. (By involvement, the study team refer to the NIHR definition: doing research ‘with’ or ‘by’ members of the public rather than ‘to’, ‘about’ or ‘for’ them).
To clarify, the study team have not involved people who participated in the original BALLETS project in this study. This is a standalone project and they recruited a new group of public members to discuss their views and perspectives on the long-term follow up of patients that consented to participate in the original study. Their insights confirmed that the BALLET study’s aims were relevant to patients and the study methods were acceptable from an ethical perspective.

Members from the Patient Involvement discussion groups were recruited from the following local groups:

• People involved in shaping local NHS Services (e.g. members of local Patient Participation Groups, public members of Clinical Commissioning Groups, members of Hospital Trust patient groups).
• People involved in research through local NIHR Centres (e.g. public advisors in NIHR West Midlands Biomedical Research Centre (WM BRC), Applied Research Centre West Midlands (ARC WM), Clinical Research Network West Midlands (CRN WM).
• Local Patient Research Ambassadors, a group convened by the West Midlands Clinical Research Network.
• People attending local patient groups (e.g. Liver and GI group, 1000 elders).

Members of the discussion group agreed to be kept informed of progress of the project and expressed a willingness to be involved in discussing the research findings, highlighting messages most important to them, and helping share the message with relevant communities.

Ways in which the study team could indirectly share the results of the study with the initial participants of the study were discussed.
Public contributors agreed that it would be important to share the research findings with people that consented to take part in the original study. It was agreed that the key findings need to be shared sensitively (informative but not ‘alarmist’) and in accessible formats. Several strategies were identified as ways to share the data in a meaningful way:

• Providing information about the BALLETS project on a website. It was agreed that the NIHR ARC WM could host information about the project.
• Providing information to GP Practices that were recruited to be part of the original study.
• Sharing findings through relevant charities.
Public contributors involved in the discussion group wanted to be involved in future discussions about sharing findings from the study future discussion group once data analysis has been completed have been agreed upon.

The Study team will work with their public contributors to co-produce materials that are in formats that are accessible. All outputs of data will be aggregated with small number suppression applied as per the HES analysis guide.

Once the study team at UoB have analysed the data, they hope to work with their contributors to identify relevant local and national organisations (including charities) to share their findings with. This would most likely include: British Liver Trust and Liver Research Foundation.

The study team hope to complete the analysis within six months of receiving data from NHS Digital. However, as an insurance against delay, the study team seek permission to hold the data for up to 18 months from receipt of the data from NHS Digital. This will enable them to complete their purpose of following up the patients from the BALLETS study to find out if they have had liver disease sufficient to warrant hospitalisation or to have been a cause of death, and ensure that the study team are able to attend to any queries from peer reviewers when submitting the results.

Processing:

METHODOLOGY
1. The University of Birmingham (UoB) holds the BALLETS study data set. As per the Confidentiality Advisory Group (CAG) section 251 advisory guidance and reference 20CAG0071, UoB will send an identifiable data set (NHS Number and Date of Birth) to UHB.

2. UHB will then extract an identifiable study cohort of 1,237 individuals (Study ID, NHS Number, Date of Birth, First Name, Last Name) and send to NHS Digital via the Secure Electronic File Transfer Service (SEFT). The cohort of 1,237 individuals treated in England are filtered by admissions and attendances with a diagnosis (ICD-10) code K70-K77 or B15-B17 or the treatment specialty was liver related, 2007/08 to 2021/22.

3. NHS Digital will use the cohort to link to HES and Mortality data, and create:
- a set of HES pseudonymised record level extracts and sent via SEFT to UHB.
- an automated record level Mortality report including identifiable data and send via SEFT to UHB.

4. UHB will then link NHS Digital data extract to the BALLETS study data using the Study ID, and then analyse the data as per the study protocol. UHB will then aggregate and suppress any small numbers and send the anonymous summary and results of the analysis to University of Birmingham. Anonymised data will be suppressed in line with the HES analysis guide.

UHB will link only the record-level identifiable data from NHS Digital to the BALLETS study data. No other linkages are permitted. The University of Birmingham will not attempt to re-identify individuals from the output they receive from UHB.

Data Minimisation

The application was submitted with the methodology that University Hospitals Birmingham NHS Foundation Trust will provide a cohort (disseminated to NHS Digital under Section 251) to NHS Digital which will link to HES OP and APC data, and NHS Digital will return the HES identifiable record-level data extracts (Study ID plus NHS Number). The Study protocol, Ethics approval and section 251 approvals all agree that this methodology is acceptable.

However, in order to further minimise the data requested and pseudonymise the HES data, NHS Digital will remove the NHS number and return only the study ID.

This linkage will enable UHB to access the baseline information required for analysis (such as the BMI, age, sex test results of the patients and relevant dates.

All processing of record-level data received from NHS Digital will be performed by substantive employees of UHB. When the analysis is complete, aggregated results with small numbers suppressed from the analysis will be shared with UoB and included in a jointly written peer-reviewed publication. The aggregated results will have small numbers supressed in line with the current version of the HES Analysis Guide.

When UHB receives the requested data from NHS Digital, it will be linked with the data set for the original BALLETS study. The association between each outcome and the presence (and degree) of Fatty Liver in the BALLETS study will be investigated using appropriate statistical methodology (e.g. logistic regression) adjustments will be made for baseline risk factors including BMI, alcohol intake, age, sex and ALT. A survival analysis will also be undertaken on all cause, and liver-related mortality by UHB. The results of these analyses will be shared with collaborators from UoB (ensuring that small numbers have been supressed).

All employees at UHB must undergo annual information governance training, which includes passing the subsequent test.

The data are both processed and stored on a secure SQL* server which sits within the Trust's IT framework, and is not available for querying by any unauthorised external parties or tools. Passwords are strictly controlled by UHB IT services, with access permissions for each user administered on the authorisation of UoB through an identified senior member of staff at UHB. The physical servers are located on site at UHB in a locked storage room where entry in and out of the rooms is logged and controlled by senior managers.

*SQL is a domain-specific language used in programming and designed for managing data held in a relational database management system, or for stream processing in a relational data stream management system.

Statistical data analysis will be carried out via UHB owned remote device connected to the UHB network either directly in person or remotely, using an appropriate statistical package (either R or STATA). To remotely access the devices requires a secure 2-factor authenticator (VPN) and users are then able to securely access the secure SQL server on the Trust’s IT framework. All data analysis will be conducted within the confines of the Trust’s secure server, and will not be downloaded to remote devices for storage or processing.

UHB use datacentre-as-a-service (co-location) from Crown Hosting, a HM Government-approved datacentre facility, supplied by ARK Data Centres. The server and storage equipment is Trust owned and operated via a privately dedicated link to UHB. IT Services span the local network to the servers and storage hosted at ARK Data Centres, accessing data using the same protocols that UHB do with servers and storage at their other location. Therefore, ARK Data Centres do not access data held under this agreement as they only supply the building. Therefore, any access to the data held under this agreement would be considered a breach of the agreement. This includes granting of access to the database[s] containing the data.

UHB will undertake processing activities on behalf of UoB. UHB may provide expertise and guidance about the processing activities, but the ultimate decision-making lies with UoB. UHB will undertake no processing activities in relation to this application without the explicit approval of UoB.

HES DISCLOSURE CONTROL / SMALL NUMBER SUPPRESSION
In order to protect patient confidentiality, when presenting results calculated from HES record level data, outputs will contain only aggregate level data with small numbers suppressed in line with HES Analysis Guide. When publishing HES data, you must make sure that:
· cell values from 1 to 7 are suppressed at a local level to prevent possible identification of individuals from small counts within the table.
· Zeros (0) do not need to be suppressed.
· All other counts will be rounded to the nearest 5.
Data will not be made available to any third parties other than those specified except in the form of aggregated outputs with small numbers suppressed in line with the HES Analysis Guide.

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Baby Biome Study — DARS-NIC-121483-R8P9F

Type of data: information not disclosed for TRE projects

Opt outs honoured: Anonymised - ICO Code Compliant, No (Consent (Reasonable Expectation))

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

Purposes: No (NHS Trust)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2018-12-01 — 2021-11-30 2021.06 — 2021.06.

Access method: One-Off

Data-controller type: UNIVERSITY COLLEGE LONDON (UCL), UNIVERSITY OF BIRMINGHAM

Sublicensing allowed: No

Datasets:

1. Civil Registration (Deaths) - Secondary Care Cut
2. Hospital Episode Statistics Accident and Emergency
3. Hospital Episode Statistics Admitted Patient Care
4. Hospital Episode Statistics Critical Care
5. Hospital Episode Statistics Outpatients
6. Civil Registrations of Death - Secondary Care Cut
7. Hospital Episode Statistics Accident and Emergency (HES A and E)
8. Hospital Episode Statistics Admitted Patient Care (HES APC)
9. Hospital Episode Statistics Critical Care (HES Critical Care)
10. Hospital Episode Statistics Outpatients (HES OP)

Objectives:

The Baby Biome Study (BBS) is a longitudinal study of mother-infant pairs, which aims to address fundamental population-level questions about infectious and immunological determinants of human health and disease. The study will collect biological samples and a range of demographic, social, and clinical exposure data from mothers and their babies around the time of birth, with follow-up through six and twelve month questionnaires and through subsequent routine health-record linkage to measure childhood health outcomes. The mothers have provided specific consent to health data record linkage for them and their babies.

This application/agreement is the initial feasibility stage of the study which involves a collaboration of researchers and clinicians from University College London (UCL), University of Birmingham (UOB), and University Hospitals Birmingham NHS Foundation Trust (UHB). UCL and UoB are acting as the joint Data Controllers in relation to this study, and have engaged University Hospitals Birmingham (UHB) for the data management element of the study (managing and administering the database), acting under instruction from the data controllers

The feasibility study requires data to demonstrate that it is possible to:
(1) identify mothers and babies, who are consenting participants of the Baby Biome Study (BBS), in NHS Digital held secondary healthcare datasets and mortality information;
(2) extract and assess data quality for health and mortality outcomes and usage of secondary health care services; and
(3) use the data provided by NHS Digital in combination with the Baby Biome Study dataset to investigate whether there is a correlation between exposures measured in Baby Biome Study (e.g. mode of delivery or baby gut microbiota patterns) and health outcomes measured using the data provided by NHS Digital (e.g. secondary care attendance for febrile, respiratory, or gastrointestinal illness).

The overall aims of the full study are to investigate the relationships between infant microbiota and the immune system, environment, clinical and feeding practices and subsequent health outcomes. To do this, the study will link routinely collected health record data with data collected at recruitment which includes biological samples from mother and child, as well as information relating to the maternity episode from the recruiting hospital (observations, prescriptions, blood test results, procedures and diagnoses). Additional data collected from the mother includes a number of health and lifestyle questionnaires.

The initial feasibility stage will test whether it is possible to link the data obtained from the 3,400 mothers and their babies (approximately 6,800 participants), who have already consented to take part in the study. An evaluation of the ability to link the individual dataset's will be carried out, reporting on the quality and number of gaps of missing data, for each dataset. The evaluation will reveal each dataset's limitations and benefits, and the possibility of data linkage as the patient cohort expands.

The feasibility study requires data from NHS Digital relating to secondary health care services, as well as mortality information, providing the details of secondary health care usage for both mothers and their babies, who are consented participants of the Baby Biome Study. The long-term importance of this data linkage will allow the team to understand the longer term health outcomes and usage of secondary health care services. In addition, the importance of this data linkage will allow for exploration of causal relationships between microbiota data acquired at birth, the clinical processes throughout (such as antibiotic exposure and/or caesarean section) and long-term health outcomes. All work will be carried out within the UK.

The initial aims of the feasibility study that will be supplemented and improved by the inclusion of data from NHS Digital are:
1) Quantify the proportion of study participants for whom data linkage is possible
2) Assess data quality for routine data for study participants (missing data and cross-check against study database for known variables such as age).
3) Use the data for this study only, to investigate whether there is a correlation between neonatal immune responses and health outcomes (with a particular focus on febrile, respiratory or gastrointestinal illnesses).

Expected Benefits:

The Baby Biome Study is urgently needed to investigate the long-term health impacts of common healthcare interventions at birth, including caesarean section and antibiotic administration, and understand how the gut microbiota and immune system interact to drive diseases including obesity, eczema, and asthma. The aspiration is to undertake a study that will report major scientific results within the first 5-10 years that inform the design of clinical trials and influence clinical and public health policy and practice to improve child and maternal health.

This is part of a long-term project. For this feasibility study, the initial measurable outcome for this study will be the successful application for funding for the expansion of this project.

For the overall programme, the aim is to see whether there are any causal links between early life colonisation with microbes, the baby immune system, clinical processes and subsequent child health outcomes such as infant weight gain, eczema, asthma, and febrile, respiratory or gastrointestinal illness. These studies will potentially inform the design of clinical trials or changes to clinical policy and practice to improve child health.

Outputs:

Data from this feasibility study will be used to provide evidence for an application for funding for an expansion of this study to undertake recruitment of 80,000 mothers and their babies.

Results from the feasibility study will be presented at national and international scientific conferences. Examples of possible conferences planned include the World Antimicrobial Resistance Congress and the Conference of the Association of Maternal and Child Health focusing on child and maternal health, infectious disease, and the microbiota. Dates of the planned conferences have not yet been confirmed but it is expected to be late 2019 and throughout 2020. The primary aim here is a proof of concept and demonstration to potential funders and other stakeholders that it is possible to get access to the necessary data through NHS Digital - this has been a major source of concern. Given this, it is possible but unlikely that something of clinical significance will be found at this stage that would be worth reporting.

These outputs will include information about the process of linkage and the quality of data available for the purposes of this study. All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.

Processing:

Participants were recruited to the study from three participating recruitment centres; Barking, Havering and Redbridge University Hospitals NHS Trust, University Hospitals Leicester and University College Hospital London and asked to give consent for them and their babies to link the data collected directly from the patient with routinely collected data sources.

Data processing and analysis will be completed by University Hospitals Birmingham NHS FT (UHB), the University of Birmingham (UoB), and University College London (UCL), as named in this agreement. All personnel who process and handle the data are substantive employees of either UHB, UoB, or UCL respectively.

A central data warehouse will be housed within University Hospitals Birmingham NHS FT (UHB) servers. This warehouse will hold all the information from the recruiting centres for example prescribing, microbiology, radiology/ultrasound, infection control, maternity, and other study data from microbiota and questionnaires.

UHB will securely transfer a file of identifiers (NHS number, Date of birth, Surname, and Gender) and study ID of the cohort to NHS Digital for linkage to hospital and mortality data. The linked hospital and mortality data including the study ID and no other identifiers is then returned to UHB. The linked data containing the study ID is stored within the central data warehouse separately from the identifiers and is not re-linked. UHB will then securely transfer the pseudonymised dataset to UoB for processing and analysis, through secure FTP transfer. UoB is then responsible to send the data (through secure FTP transfer) in a pseudonymised version to UCL for them to check the analysis and provide clinical oversight.

There will be no data linkage undertaken with NHS Digital data provided under this agreement that is not already noted in the agreement. The pseudonymised data from NHS Digital is not re-linked to the direct identifiers at any point.

As this is a feasibility study, a comprehensive list of patient data for the cohort is required. From this analysis it may be possible to apply further filters in the future (i.e. perhaps a finding is discovered about a specific age group of patients and then at that point a filter could be placed based on this age group).

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).

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Linking and Evaluation of SABR CTE Patients — DARS-NIC-150435-R7X1Q

Type of data: information not disclosed for TRE projects

Opt outs honoured: No - consent provided by participants of research study, Identifiable, No (Consent (Reasonable Expectation))

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

Purposes: No (NHS Trust)

Sensitive: Non Sensitive, and Non-Sensitive

When:DSA runs 2018-10-04 — 2020-12-31 2018.10 — 2019.06.

Access method: One-Off

Data-controller type: KING'S COLLEGE LONDON

Sublicensing allowed: No

Datasets:

1. Hospital Episode Statistics Admitted Patient Care
2. Hospital Episode Statistics Outpatients
3. HES:Civil Registration (Deaths) bridge
4. Civil Registration (Deaths) - Secondary Care Cut
5. Civil Registration - Deaths
6. Civil Registrations of Death - Secondary Care Cut
7. Hospital Episode Statistics Admitted Patient Care (HES APC)
8. Hospital Episode Statistics Outpatients (HES OP)

Objectives:

Stereotactic Ablative Radiotherapy (SABR) is an emerging novel radiation technology. SABR is a specialised radiotherapy treatment planning technique resulting in a high dose to the target with steep dose gradients resulting in rapid dose fall off outside the target area. This results in high biologically effective dose (BED) while minimising the dose received by the normal tissues, and could potentially minimise the radiotherapy treatment toxicity and side effects.

The technique requires specialist positioning equipment and/or imaging (stereotaxis) to confirm correct targeting (accuracy) and it can be delivered using either standard linear accelerators or specially designed devices which are dedicated to delivering stereotactic treatments. Using a small number of fractions provides the opportunity for cost savings compared with conventional fractionation or surgical alternatives, and may free up capacity within NHS radiotherapy departments.

The current SABR indications for which evidence is rapidly accumulating are:
• oligometastatic cancer (3 or fewer sites of metastatic disease)
• cancer that has recurred in a site treated previously treated with radiotherapy (re-irradiation)
• patients with hepatocellular carcinoma

These 3 groups of patients should receive SABR within this Commissioning through Evaluation (CtE) project, which will serve to improve access to SABR within the UK and enable data collection to further expand the current evidence base. It is possible that additional indications will be added to the program in due course, including benign spinal conditions and renal cancer.

This study has been commissioned by the National Institute for Health and Care Excellence (NICE) to support NHS England’s Commissioning through Evaluation (CtE) programme. As part of this CtE project the centres delivering SABR treatment will be collecting routine clinical data and data on quality of life, pain symptoms and patient experience using the interim access tool developed by King’s Technology Evaluation Centre (KiTEC - part of King's College London). KiTEC will be undertaking the analysis of this data in order to answer the NHS England evaluation question whether the treatment offers to these patients improved clinical outcomes in combination with less side effects and improved quality of life.

The evaluation scheme is being run for three years in a total of fifteen specialised centres in England, although not all centres are offering SABR to all three sets of patients. The first patient was recruited in June of 2015, and it is currently anticipated that patients will be enrolled up until September-2018, with patients being followed up for two years. As of September 2018, the number of patients recruited across all seventeen participating centres is approximately 1,700.

This CtE project has HRA ethics approval for the analysis of these patient data already recorded by the NHS Trusts delivering SABR in a pseudonymised format by KiTEC. This is, therefore, a low-risk observational data analysis.

The research is non-interventional as it deals with the collation of routine outcome data already collected after patients provide informed consent as part of their clinical management to undergo SABR. Consent to undergo SABR has been undertaken by the individual NHS Trusts.

The patients have consented for their data to be analysed by KiTEC. This consent is separate to their treatment consent.

This project seeks to identify the impact in secondary care health settings taking into consideration all contacts with hospitals. KiTEC are requesting data from NHS Digital to add to the commissioning through evaluation database that is currently being populated, as patients may see other healthcare professionals outside of the trial, or their participating centre. All of the work will take place within the UK.

KiTEC are acting as the sole Data Controller in relation to this study, and have engaged University Hospitals Birmingham (UHB) for the data management element of the study (managing and administering the database), acting under instruction from KiTEC. Additionally, KITEC are responsible for undertaking any analyses, therefore pseudonymised patient-level data will need to be shared between UHB and KiTEC.

A report that describes the evidence for the clinical and cost-effectiveness of SABR will be presented to the UK SABR consortium, NHS England, and NICE and will be used to inform future commissioning. Following review by the project's stakeholders, this report will be then submitted for publication in peer review journals. Outputs from the project will contain only data that is aggregated (with small numbers suppressed in line with the HES Analysis Guide).

The evaluation should show that there is an improvement in patient outcomes and a reduced burden on the NHS for subsequent treatment of complications and recurrence.

Expected Benefits:

This project is evaluating the effectiveness of Stereotactic Ablative Radiotherapy (SABR), an emerging novel radiation therapy technology in three specific areas outlined. The three areas include: oligometastatic cancer, cancer recurred in a site treated previously with radiotherapy, and patients with hepatocellular carcinoma. SABR is a specialized radiotherapy technique that delivers a high dose of radiation to the tumour while minimising the dose received by normal tissues, potentially minimising radiotherapy treatment toxicity and side effects. This project will look at both the impact on the patients as well as the financial impact to the NHS. This project will determine whether the treatment under investigation has both a positive benefit for patients and the NHS, or whether it has any disadvantages that have not previously been identified. If the findings are positive then this treatment may mean that patients end up undergoing fewer unsuccessful treatments and that the patient experience and survival are improved.

Outputs:

Outputs from the project will contain only data that is aggregated (with small numbers suppressed in line with the HES Analysis Guide).

A final report on the analyses will be generated by KiTEC for NHS England and NICE that will answer the questions below:
- What is the 1-year and 2-year survival following treatment with SABR for the indications covered by the Commissioning through Evaluation (CtE) scheme (presented as estimates with confidence intervals)? How do these survival estimates compare with the target outcomes (see section 4), in terms of superiority or non-inferiority?
- Does treatment with SABR for the clinical indications covered within the CtE scheme increase LC?
- What Adverse Events occur as a result of SABR in the CtE cohort of patients?
- What is the patient experience of treatment with SABR for the clinical indications covered within the CtE programme?
- What is the cost-effectiveness of providing SABR in three subgroups of patients covered within the CtE scheme (oligometastases (liver), HCC, and pelvis re-irradiation)?
- What are the outcomes by indication in the CtE cohort of patients?
- Are there any factors from the experience of centres participating in the scheme that should be taken into account in terms of future service provision?
- Are there any research findings that have become available during the course of the CtE scheme that should be considered alongside the evaluative findings of the CtE scheme?

The final report will follow the NHS England and NICE guidelines for the production of such a report.

As well as the final report for NHE England and NICE, peer-review papers will be produced by both UHB and KiTEC, these reports will be on aggregate analyses, and will only include supplementary information from HES/ONS which will have the small numbers suppressed. The information may also be presented at relevant national and international conferences.

No outputs are planned specifically for any charities or patient groups [because the focus of the study is to influence commissioning policy (through NICE and NHS England), and it is at the point of any decision to change policy that the findings of the study will be addressed to the public], however, the report containing the results of KiTEC’s analysis for the Commissioning through Evaluation (CtE)” programme, when finalised, will be made publicly available. KiTEC will also produce a publication that will be made available to the public through open access; a direct link will be displayed on the KiTEC website.

Processing:

The aggregated SABR procedures numbers by centre, is required on a quarterly basis. This number will be compared with the number of procedures included in the database. Should there be a discrepancy, the data lead or data processor for that centre will need to be contacted. For the avoidance of doubt, this will not require HES data to be shared with the participating centres.

KiTEC are acting as the sole Data Controller in relation to this study, and have engaged University Hospitals Birmingham (UHB) for the data management element of the study (managing and administering the database), acting under instruction from KiTEC. KITEC are responsible for undertaking any analyses, therefore pseudonymised patient-level data will need to be shared between UHB and KiTEC.

UHB will create a pseudonymised extraction of data on a bi-monthly basis which will be sent to KiTEC for them to complete their analyses. All data shared from UHB to KCL will be pseudonymised.

In addition, identifiable data captured in the SABR database will need to be linked to relevant HES/Mortality records. This will enable accurate mortality data to be captured, as well as data on other diagnoses or procedures patients may have had at other departments (internal or external to the treating hospital), thus increasing the accuracy of the recording of both adverse event and mortality in the database. This process will require the collection of identifiable patient data (NHS number as a minimum), as well obtaining access to equivalently identifiable HES/Mortality patient records. UHB will receive and process the data.

In order to answer the evaluation question whether the treatment offers to these patients improved clinical outcomes in combination with less side effects and improved quality of life descriptive statistics will be presented to characterise the patient populations. This will include demographic and clinical factors.

Estimates of the rates of overall survival and progression-free survival (local control) at 1 year and 2 years following treatment with SABR will be calculated using the Kaplan-Meier method, for each of the three included indications (oligometastatic disease, re-irradiation of pelvis/spine, and hepatocellular carcinoma). A measure of the precision of each estimate will be provided by 95% confidence intervals. Kaplan-Meier graphs will be presented for key outcomes.

Survival estimates will be compared narratively with the ‘target outcomes’ for each condition (i.e. not using statistical tests), since the target outcomes were informed by a mixture of relevant literature and expert opinion, and therefore, there is no appropriate ‘sampling error’ which can be attributed to these outcomes (a requirement of statistical tests).

The number and percentage of adverse events following treatment with SABR will be presented with 95% confidence intervals, for each of the three indications.

The cost-effectiveness of providing SABR in cohorts of patients included in the CtE scheme (oligometastases, re-irradiation and hepatocellular carcinoma (HCC)) will be evaluated using a commonly applied Markov model of cancer. The model will include three states: progression free; progression; and death. Progression will be defined as the failure of local control. Patients accrue costs and quality-adjusted life expectancy for each period or time cycle they spend in either progression-free or progression states. Patients transit in the direction of the arrows with a given probability at the end of each time cycle and the model is run over a defined number of cycles (periods of time) allowing an estimate of total costs and quality-adjusted life expectancy for the cohort over the specified time period.

The following describes the flow of data for the SABR Study without data from NHS Digital:
1) Treatment centres collect data about the patients
2) Treatment centres submit the data (routine clinical data, quality of life, pain symptoms, etc.) to UHB.
3) UHB store the data on their servers
4) UHB send bi-monthly extracts of the pseudonymised data to KiTEC for analysis

The following describes the flow of data for the SABR Study including a supply of data from NHS Digital:
1) Treatment centres collect data about the patients
2) Treatment centres submit the data (routine clinical data, quality of life, pain symptoms, etc.) to UHB.
3) UHB store the data on their servers
4) UHB provide patient identifiers to NHS Digital which NHS Digital will use to identify relevant HES and mortality data
5) NHS Digital supplies hospital and mortality data to UHB
6) UHB stores the data on their servers
7) UHB send bi-monthly extracts of the pseudonymised data to KiTEC for analysis

The only data linkage permitted with NHS Digital data is the link with the data submitted by NHS treatment centres.

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 i.e.: employees, agents and contractors of the Data Recipient who may have access to that data).

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