NHS Digital Data Release Register - reformatted

Leeds Teaching Hospitals NHS Trust projects

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

Avoiding Cardiac Toxicity in lung cancer patients treated with curative-intent radiotherapy to improve survival ( ODR1819_034 ) — DARS-NIC-656824-R8K0V

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(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'., Health and Social Care Act 2012 - s261(2)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.

Purposes: No (NHS Trust)

Sensitive: Sensitive

When:DSA runs 2024-03-27 — 2024-12-11 breached contract — audit report.

Access method: One-Off

Data-controller type: LEEDS TEACHING HOSPITALS NHS TRUST, THE CHRISTIE NHS FOUNDATION TRUST

Sublicensing allowed: No

Datasets:

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

Objectives:

Leeds Teaching Hospitals NHS Trust and The Christie NHS Foundation Trust requires access to NHS England data for the purpose of the following research project: Avoiding Cardiac Toxicity in lung cancer patients treated with curative-intent radiotherapy to improve survival.

The following is a summary of the aims of the research project provided by Leeds Teaching Hospitals NHS Trust and the Christie NHS Foundation Trust:

Primary Objective
To validate correlations between the radiotherapy dose to the heart and survival as demonstrated in the Manchester cohort in data obtained from patients in Leeds, using the same data/image analysis technique.

Secondary Objectives
Evaluate factors other than dose to areas of the heart that could increase the risk of early death after radiotherapy treatment:
1. Quantify coronary calcifications in patients treated with curative-intent radiotherapy and correlate with survival and clinical risk factors.
2. Correlate risk factors by differentiating the heart disease risks.
3. Ascertain the cause of death


The following NHS England Data will be accessed:
• NDRS Linked Cancer Registration
• NDRS Linked HES Admitted Patient Care (HES APC)
• NDRS Radiotherapy Dataset (RTDS)
• NDRS Systemic Anti-Cancer Therapy Dataset (SACT)


The level of the Data will be identifiable to link with scans, other medical history. as detailed before and in the initial application, identifiable data is retained within each NHS trust's systems and firewalls. Additionally, any supplementary information from Public Health England (now NHS England) is transmitted to the relevant trust in a de-identified format. This approach ensures that sensitive data remains protected while still enabling analysis and sharing for research purposes.

The Data will be minimised by selecting patients who received curative intent radiotherapy in the Leeds Teaching Hospitals NHS Foundation Trust and The Christie NHS Trust for lung cancer, between 01/01/2010 and 30/12/2016.


Leeds Teaching Hospitals NHS Trust and The Christie NHS Foundation Trust are joint controllers and are the research sponsors and the controllers as the organisation responsible for ensuring that the Data will only be processed for the purpose described above.


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


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

This processing is in the public interest because understanding the link between the dose of radiotherapy treatment and potential damage to surrounding organs e.g. the heart is vital in informing radiotherapy treatments for future patients. Identification of organs/parts of organs which are most sensitive to radiation toxicity will allow these areas to be designated organ at risks and for future radiotherapy treatment to be designed to minimise dose to these areas and therefore reduce side-effects of radiotherapy treatment.


The funding is provided by Yorkshire Cancer Research grant. The funding is specifically for the study described. Funding is in place until 31-Mar-2023.
The funder will have no ability to suppress or otherwise limit the publication of findings.


Data will not be accessed by individuals other than substantive employees of the organisations Leeds Teaching Hospitals NHS Trust and The Christie NHS Foundation Trust.


Leeds Teaching Hospitals NHS Trust and The Christie NHS Foundation Trust did not have any PPI involvement in the original proposal or on the trial management group. The study has been REC and CAG approved who have PPI involvement.

Yielded Benefits:

The extended research presented at European Society of Therapeutic Radiation Therapy (ESTRO) conference in 2020, titled "Association between pre-existing heart disease, radiotherapy dose, and cardiac deaths in lung cancer," has undergone an internal review and is about to be submitted. The work presented at ESTRO 2021 has been written up as journal article. It is now at the final draft stage, and the plan is to submit it after summer 2023. This study focuses on the relationship between cardiac death, cardiac admission, and dosimetric parameters of cardiac substructures. Depending on the feedback received from journals, Leeds Teaching Hospitals NHS Trust would wish to retain access to the data to provide any additional information that might be required. Update as per latest confirmation report submitted 15/02/2024: This project aims to understand the link between the dose of radiotherapy treatment given to treat patients with lung cancer and potential damage caused to surrounding organs, including the heart, which is caused by the radiation therapy. The project has combined retrospectively collected radiotherapy data from the Leeds Teaching Hospitals NHS Foundation Trust and the Christie NHS Trust, in Manchester, to investigate this. Patients have been identified from electronic radiotherapy records held at each institution by members of the clinical care team. This patient information has then been linked by Public Health England to the National Cancer Registration and Analysis (NCRAS) dataset. The Leeds Teaching Hospitals NHS Foundation Trust and the Christie NHS Trust have analysed the relationship between cardiac death, cardiac admission, and dosimetric parameters (from radiotherapy treatment) of cardiac substructures. These results have been present at the European Society of Therapeutic Radiation Therapy (ESTRO) conference in 2020, titled "Association between pre-existing heart disease, radiotherapy dose, and cardiac deaths in lung cancer.” This work has since been written up as journal article with a plan to submit early 2024. To build on this work the Leeds Teaching Hospitals NHS Foundation Trust and the Christie NHS Trust have engaged in further analyses to enhance their understanding of the correlation between dosimetric parameters and cardiac related deaths in patients with lung cancer. Firstly, given the correlation between cardiac-related deaths and cardiac dosimetric factors, they are now working on constructing a causality model. In addition, they are investigating the association between various conditions leading to hospitalization before treatment initiation, using data from Hospital Episode Statistics (HES), and their potential link to cardiac-related deaths within this population.

Expected Benefits:

The use of the data could:
• lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.
• Already led to the RAPID-RT study, helped inform a change in standard-of-care in lung cancer patients treated at the Christie where a dose limit has been applied to the base of the heart and continuing this work and has a comprehensive programme of public engagement embedded throughout the programme.


This project aims to understand the link between the dose of radiotherapy treatment given to treat patients with lung cancer and potential damage caused to surrounding organs, including the heart, which is caused by the radiation therapy. By identification of radiation-sensitive regions of organs e.g. the base of the heart these areas can be designated organs of risk and be assigned radiation dose limits to minimise radiation-induced damage during radiotherapy treatment. This will reduce radiotherapy side effects in patients being treated for lung cancer.

The proposed outputs will be shared with clinicians. The work done within this project has already helped inform a change in standard-of-care in lung cancer patients treated at the Christie where a dose limit has been applied to the base of the heart. The impact of this is being monitored by a NIHR-funded study RAPID-RT, to determine if this dose limit decreases the cardiac toxicity associated with lung cancer treatment.

The RAPID-RT study (mentioned above) is continuing this work and has a comprehensive programme of public engagement embedded throughout the programme including citizen jurys, workshops, patient co-applicants and a patient advisory group. Leeds Teaching Hospitals NHS Trust and The Christie NHS Foundation Trust have disseminated the work widely amongst the scientific community through attendance at numerous conferences e.g. ESTRO.

Outputs:

The expected outputs of the processing will be:
• Submissions to peer reviewed journals
• Presentations at national and international conferences
• Participants will be provided with a contact address and email from which to obtain results from the study and copies of publications.


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


The outputs will be communicated to relevant recipients through the following dissemination channels:
• Journals
• Public events such as conferences
• Participant newsletters published online

Leeds Teaching Hospitals NHS Trust and The Christie NHS Foundation Trust seek to extend the contract by an additional 12 months, until 11th December 2024, allowing sufficient time to conduct thorough analyses and then go through the peer-reviewed paper submission and publication.

Processing:

Leeds Teaching Hospitals NHS Trust and The Christie NHS Foundation Trust will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth, Gender and a unique person ID) for the cohort to be linked with NHS England data.


NHS England will provide the relevant records from the NDRS Linked Cancer Registration, NDRS Linked HESAPC, NDRS RTDS and NDRS SACT datasets to Leeds Teaching Hospitals NHS Trust and The Christie NHS Foundation Trust. The Data will contain directly identifying data items including Date of Death which are required to confirm local data, aid interpretation of research question relating to lung cancer radiotherapy and heart toxicity.

The additional fields sought will be added by NCRAS and then returned to the individual trust; only identifiable records for patients known to each provider will be transferred. Once the data is received by the relevant trusts will be linked to the local collected data and re-anonymised within the respective hospital’s trust IT infrastructure for subsequent analysis.


The Data will not be transferred to any other location.


The Data will be stored on servers at Leeds Teaching Hospital NHS trust and The Christie NHS Foundation Trust.


The Christie uses offsite back-up services provided by The University of Manchester.
Leeds Teach Hospital NHS uses a different room, in a different firezone on a different floor in the building.


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

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

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

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


Remote processing will be from secure locations within England/Wales. The data will not leave England/Wales at any time.


Access is restricted to employees or agents of Leeds Teaching Hospitals NHS Trust and The Christie NHS Foundation Trust who have authorisation from the Principal Investigator.

Employees or agents of Leeds Teaching Hospitals NHS Trust and The Christie NHS Foundation Trust are permitted to access pseudonymised data only.

No other organisation is permitted to access the Data.


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


The Data will not be linked with any other data outside of this application.


There will be no requirement and no attempt to reidentify individuals when using the Data.


Analysts from the Leeds Teaching Hospitals NHS Trust and The Christie NHS Foundation Trust will analyse the Data for the purposes described above.

MR1248 - Evaluation of outcomes from percutaneous coronary intervention to the left main coronary artery at Leeds Teaching Hospitals NHS Trust — DARS-NIC-148077-M9HG5

Type of data: information not disclosed for TRE projects

Opt outs honoured: Identifiable

Legal basis: , Other-Exception; Section 42(4) of the Statistics and Registration Service Act (2007) as amended by section 287 of the Health and Social Care Act (2012)

Purposes: No (NHS Trust)

Sensitive: Sensitive

When:DSA runs 2012-02-01 — 2026-01-31 breached contract — audit report.

Access method: One-Off

Data-controller type: LEEDS TEACHING HOSPITALS NHS TRUST

Sublicensing allowed: No

Datasets:

  1. MRIS - Cause of Death Report
  2. MRIS - Cohort Event Notification Report
  3. MRIS - Flagging Current Status Report
  4. MRIS - Members and Postings Report
  5. MRIS - Personal Demographics Service

Objectives:

Evaluation of outcomes from percutaneous coronary intervention to the left main coronary artery at Leeds Teaching Hospitals NHS Trust

Clinical outcome of patients undergoing percutaneous coronary intervention to the left main coronary artery (left main stem, LMS) at the Yorkshire Heart Centre.

MR1148 - OPERA — DARS-NIC-156407-5KJ0Y

Type of data: information not disclosed for TRE projects

Opt outs honoured: N, Identifiable, Yes, No

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

Purposes: No (NHS Trust)

Sensitive: Sensitive

When:DSA runs 2010-08-10 — 2020-08-09 2016.12 — 2018.05. breached contract — audit report.

Access method: Ongoing

Data-controller type: LEEDS TEACHING HOSPITALS NHS TRUST

Sublicensing allowed: No

Datasets:

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

Objectives:

The aim of the study is to answer two questions:
1) Does the very small amount of damage that can occur to the heart muscle during angioplasty have any long term implications for the health of the patient?
2) Can we predict which patients are more at risk of developing damage to the heart muscle during angioplasty?
Steps can then be taken before, during and after the procedure to reduce the risk and improve outcome.

Project 4 — DARS-NIC-147850-1BWPG

Type of data: information not disclosed for TRE projects

Opt outs honoured: N

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC

Purposes: ()

Sensitive: Sensitive

When:2016.12 — 2017.05. breached contract — audit report.

Access method: Ongoing

Data-controller type:

Sublicensing allowed:

Datasets:

  1. MRIS - Scottish NHS / Registration
  2. MRIS - Cause of Death Report
  3. MRIS - Cohort Event Notification Report

Objectives:

The data supplied to Leeds General Infirmary will be used only for the approved medical research project - MR1059 - The Value of H-FABP in Early Diagnosis and Risk Stratification of Patients

Project 5 — DARS-NIC-148358-68V63

Type of data: information not disclosed for TRE projects

Opt outs honoured: N

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC

Purposes: ()

Sensitive: Sensitive

When:2016.04 — 2017.02. breached contract — audit report.

Access method: Ongoing

Data-controller type:

Sublicensing allowed:

Datasets:

  1. MRIS - Cause of Death Report
  2. MRIS - Cohort Event Notification Report
  3. MRIS - Scottish NHS / Registration

Objectives:

The data supplied to BHF Heart Research Centre at Leeds will be used for the approved Medical Research Project, The Space Rocket Trial.

Expected Benefits:

To be completed by applicant

Outputs:

To be completed by applicant

Processing:

To be completed by applicant

Project 6 — DARS-NIC-148290-CJ1K6

Type of data: information not disclosed for TRE projects

Opt outs honoured: N

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC

Purposes: ()

Sensitive: Sensitive

When:2016.04 — 2016.11. breached contract — audit report.

Access method: Ongoing

Data-controller type:

Sublicensing allowed:

Datasets:

  1. MRIS - Scottish NHS / Registration
  2. MRIS - Cause of Death Report
  3. MRIS - Cohort Event Notification Report

Objectives:

The data supplied by NHS IC to Cancer Research UK Clinical Centre will be used only for the approved Medical Research Project identified above.

Project 7 — HDIS_Leeds Teaching Hospitals NHS Trust

Type of data: information not disclosed for TRE projects

Opt outs honoured: N

Legal basis: Health and Social Care Act 2012

Purposes: ()

Sensitive: Non Sensitive

When:2016.04 — 2016.08. breached contract — audit report.

Access method: Ongoing

Data-controller type:

Sublicensing allowed:

Datasets:

  1. Access to HES Data Interrogation system

Objectives:

The HES (Hospital Episode Statistics) Data Interrogation System (HDIS) allows users to securely access HES, interrogate the data, perform aggregations, statistical analysis, and produce a range of different outputs. Access to HDIS is only provided to organisations who work within the public sector with a specific interest in public health. There is a strict information governance applications process in place to protect and control how the data is managed.