NHS Digital Data Release Register - reformatted

Hull University Teaching Hospitals NHS Trust projects

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

Type of data: information not disclosed for TRE projects

Opt outs honoured: Anonymised - ICO Code Compliant (Does not include the flow of confidential data)

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

Purposes: No (NHS Trust)

Sensitive: Non-Sensitive

When:DSA runs 2024-10-14 — 2025-10-13 2024.11 — 2024.11.

Access method: System Access
(System access exclusively means data was not disseminated, but was accessed under supervision on NHS Digital's systems)

Data-controller type: HULL UNIVERSITY TEACHING HOSPITALS NHS TRUST

Sublicensing allowed: No

Datasets:

NDRS Cancer Consolidated Data Set

Objectives:

Hull University Teaching Hospitals NHS Trust (HUTH) requires access to NHS England data for the purpose of the following research project:

Evaluating the current standard of care for patients diagnosed with malignant melanoma of the head and neck access to staging and surgical treatment.

Melanoma is the 5th most common cancer in the UK and is treated by removing the cancer with an operation. Early spread can be detected through sampling of nearby lymph nodes - sentinel lymph node biopsy (SLNB). SLNB is readily available for patients with melanoma of the torso and limbs, but not everywhere offers SLNB for head and neck melanoma, for a variety of reasons. However, this may result in some patients not having access to new, systemic treatments that prolong life.

The aim of this study is to examine how practice varies nationally, looking at who is offered SLNB after melanoma of the head or neck, what treatments they go on to have, and whether they recover from their melanoma or not with the aim of identifying whether SLNB should be made available to everyone in this group.

The following is a summary of the aims of the research project provided by HUTH:
Overall aim: To evaluate the burden of disease of head and neck melanoma in the last 5 years, including additional treatments and access to SLNB.
Primary outcomes:
- What proportion of patients diagnosed with cutaneous melanoma of the head and neck go on to have SLNB?
- How does this compare to the proportion of patients with cutaneous melanoma in other parts of the body that go on to have SLNB?
Secondary outcomes
- What is the tumour stage of patients with cutaneous melanoma of the head and neck who have SLNB compared to those who do not?
- Do a higher proportion of patients with cutaneous melanoma of the head and neck who have had an SLNB have systemic anti-cancer therapies (or other treatments) for comparable T stage?
- Is there a variation in provision of SLNB for cutaneous melanoma of the head and neck across England?

The following NHS England Data will be accessed:
(NDRS) Cancer Consolidated Dataset (Package 10 & 12).
necessary as this will allow identification of patients diagnosed within the study period with malignant melanoma of the head and neck and which of those would be eligible, if available, for SLNB and allow the 1- and 3-year mortality for the relevant members of the study cohort.

The level of the Data will be:
Pseudonymised

The Data will be minimised as follows:
Limited to a study cohort identified by NHS England as meeting the following criteria: cancer patients over 18 years of age.
Limited to data between 01/01/2016 and 31/12/2022.
Limited to conditions relevant to the study identified by specific ICD codes.
Limited to the geographic area of England.

HUTH is the controller who also processes the data 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 it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients treatments or care.

The funding is provided by the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS) through a grant. The funder will have no ability to suppress or otherwise limit the publication of findings.

The Principal Investigator for this study is substantively employed by the University of Hull. This individual holds an honorary contract with Hull University Teaching Hospitals NHS Trust (the Controller). The University of Hull will have no access to the data, nor have any influence on the study, its results, or the dissemination of the results thereof.

In line with the national data opt-out policy, opt-outs are not applied because the data is not Confidential Patient Information as defined in section 251(10) and section 251(11) of the National Health Service Act 2006.

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

Expected Benefits:

The findings of this research study are expected to contribute to evidence-based decision-making for policy-makers, 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.
Inform planning health services and programmes, for example to improve equity of access, experience and outcomes.
Inform decisions on how to effectively allocate and evaluate funding according to health needs.
Provide a mechanism for checking the quality of care. This could include identifying areas of good practice to learn from, or areas of poorer practice which need to be addressed.
Support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work).

The dissemination plan above has a number of potential benefits. If the results show a geographical discrepancy in the provision of staging surgery for this common cancer, then the study will be in a strong position to advocate for clearer guidelines on the matter. At present, national guidelines allow for local variation in head and neck SLNB due to concern over greater operative difficulty and greater variability in lymphatic spread in this area. If the study is able to show through it's dataset that outcomes are improved for those who undergo SLNB, then it can advocated for wider access to this procedure for patients. This will be beneficial in both the provisioning of healthcare and is in the public interest (as the public stands to gain from wider access and improved outcomes).

The dissemination plan has been designed to maximise exposure for our results. By disseminating to melanoma-specific charities, as well as the scientific community, our results may be leveraged by charitable stakeholders as well as clinicians in the production of new/updated guidelines.

Displaying or disproving a benefit from access to SLNB, or showing geographical variance, stands to benefit large numbers of patients. Over 2,500 new cases of melanoma of the head and neck are diagnosed every year and though not all of these would be suitable for SLNB, hundreds of patients may be eligible for this staging procedure. Adequate staging may qualify them for further treatment and in turn confer a survival benefit. Furthermore, strong evidence for a geographical variance can be used to standardise procedures available to patients on the NHS (through training or service development in individual NHS trusts). In order to measure any benefit from the outcomes of this work, further prospective research may be needed.

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.

Outputs:

The expected outputs of the processing will be:
Annual reports of findings to the funder (BAPRAS).
Submissions to open access peer reviewed journals.
Presentations at appropriate national/international conferences.
Reports to public bodies/stakeholders focussed on melanoma, or skin cancer as a whole.

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 (such as British Journal of Dermatology, JAMA Dermatology)
Conferences (such as BAPRAS annual conference, British Association of Dermatologists annual conference, the Society for Melanoma Research conference)
Reports aimed at public bodies/stakeholders (such as Melanoma UK [Charity], Melanoma Focus [Charity], The Skin Cancer Foundation [Charity], NICE [Guideline producer], SIGN [Guideline Producer], British Association of Dermatologists [Professional Body], BAPRAS [Professional Body])

It is anticipated that results will be available for presentation at conferences by Q3 2025. It is also anticipated that results will be submitted for publication in peer reviewed journals by Q4 2025, and once accepted, reports will be prepared for the organisations outlined above.

Processing:

No data will flow to NHS England for the purposes of this Data Sharing Agreement (DSA).

NHS England will grant access to the Data via the Secure Data Environment (SDE). The SDE is a secure data and research analysis platform. It allows approved researchers with approved projects access to pseudonymised data and industry-leading analytics tools

NHS England will provide access to the relevant records Package 10 & 12 of the NDRS Cancer Consolidated Dataset to HUTH via the NHS England Secure Data Environment (SDE).

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.

SDE users can request exportation of aggregated analysis results (suppressed and summarised according to the NHSE SDE Disclosure Control rules) subject to review and approval by the NHS England SDE Output Checking team. The SDE Output Checking team will ensure that no output contains information which could be used either on its own or in conjunction with other data to breach an individual's privacy.

Users must identify themselves via a multi-factor authentication mechanism and are only able to access the datasets detailed within this DSA. The access and use of the system is fully auditable, and all users must comply with the use of the Data as specified in this DSA.

Users are only authorised to access the Data specified in this DSA and can utilise a variety of analytical tools available within the SDE platform. Users are not permitted to export record-level data from the SDE.

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 organisations DSPT (or other security arrangements as per this DSA) and complies with the organisations 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 of HUTH who have authorisation from the Principal Investigator and an individual working under honorary contract. All personnel accessing the Data have been appropriately trained in data protection and confidentiality. The Data will not be linked with any other data.

There will be no requirement and no attempt to reidentify individuals when using the Data.
Analysts/researchers from HUTH will process/analyse the Data for the purposes described above.