NHS Digital Data Release Register - reformatted

Liverpool University Hospitals NHS Foundation Trust projects

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

Safety and feasibility of triage and rapid discharge of patients with chest pain from emergency room: a pragmatic, randomised non-inferiority control trial of the European Society of Cardiology (ESC) 0–1 hour pathway vs. conventional 0-3 hour accelerated diagnostic protocol. — DARS-NIC-756799-M4K3V

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

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

Purposes: Yes (NHS Trust)

Sensitive: Non-Sensitive

When:DSA runs 2024-12 – 2025-12 2025.01 — 2025.01.

Access method: One-Off

Data-controller type: LIVERPOOL UNIVERSITY HOSPITALS NHS FOUNDATION TRUST

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Admitted Patient Care (HES APC)

Type of data: Identifiable

Objectives:

Liverpool University Hospitals NHS Foundation Trust requires access to NHS England data for the purpose of the following research project:
Safety and feasibility of triage and rapid discharge of patients with chest pain from emergency room: a pragmatic, randomised non-inferiority control trial of the European Society of Cardiology (ESC) 0–1 hour pathway vs. conventional 0-3 hour accelerated diagnostic protocol.

The following is a summary of the aims of the research project provided by/on behalf of Controller:

The current practice in Liverpool University Hospital Foundation Trust is to take a blood sample when the patient presents to accident and emergency and then to repeat this after 3 hours. If the blood tests detect a rise in the troponin levels, then the patient is likely to have suffered a heart attack. It is also possible to repeat the test at 1 hour rather than 3 hours. The advantage of this is potentially shortening the patients stay in the emergency department. Recent evidence from the High Sensitivity Cardiac Troponin T assay for rapid Rule-out of Acute Myocardial Infarction (TRAPID-AMI) study suggests that this is just as safe and facilitate safe discharge of more patients. The evidence has persuaded the European Society of Cardiology to include this in their 2020 guidelines.

However, what is not clear is how well this new pathway (the 0/1-hour pathway- taking a blood sample at presentation and after 1 hour from presentation) works in practice in a busy and stressful department. It is possible due to time constraints that the repeat sample at 1 hour would be too difficult to work in practice.

The study purpose is to introduce the 0/1-hour pathway in Liverpool University Hospital Foundation Trust, which is approved for use, but at the same time the primary objective of this study is to understand if, in practice, it performs better than the current 0/3-hour pathway being used.

The principal outcome measure will be the safety of the 0-1 hour protocol (which is less established and has limited data on safety when implemented in clinical practice)

The following NHS England Data will be accessed:
• Hospital Episode Statistics
o Admitted Patient Care – necessary to inform whether a patient presented to another acute hospital within 30 days of presentation.

The level of the Data will be:
• Identifiable

The Data will be minimised as follows
• Limited to a study cohort identified by Controller – a cohort of 3751 consented participants.

The Liverpool University Hospitals NHS Foundation Trust is the research sponsor and the controller as the organisation responsible for ensuring that the data will only be processed for the purpose described above.

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

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

The funding comes from multiple sources. Current funders include:
• Innovation agency
• Liverpool University Hospital NHS Foundation Trust
• Menarini UK,
• Abbott Diagnostics
• Liverpool University hospital NHS FT. Charities, General cardiology fund
• Quidel Cardiovascular Inc
• Siemens Healthcare Diagnostics Limited.
• Personal research Funds Dr Aleem Khan.

Funding to continue the work described will be sought on an ongoing basis.

The funder(s) will have no ability to suppress or otherwise limit the publication of findings.

The funders have not played a part in the design or statistics related to this project, which is exclusively been directed by the Controller.

This research project is funded partly by commercial organisations. The manufacturers (Siemens and Quidel) of the two novel point of care assays, being tested, have provided funding to the study.

Both will be looking to use the data that is published, independently as evidence to get NICE approval in the UK for their devices.

No identifiable data will be accessed by any individual outside of Liverpool University Hospital NHS Foundation Trust.

Only substantive employees of Liverpool University Hospital NHS Foundation Trust will access the data.

This research project is funded partly by commercial organisations. The manufacturers (Siemens and Quidel) of the two novel point of care assays, being tested, have provided funding to the study. Both will be looking to use the data that is published, independently as evidence seeking NICE approval in the UK for their devices.

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 practices to improve the care, treatment and experience of health care users relevant to the subject matter of the study.

The Study will greatly enhance knowledge of the safety of the 0/1hour against the 0/3 hour algorithm for the rule out of myocardial infarction. It will be the largest randomised controlled trial in this space.

The Study will inform policy makers including European and American Societies of Cardiology and NICE. Not only on use of such algorithms but also clinical performance of two novel point of care high-sensitivity troponin assays.

The direct result of this work will be that Liverpool University Hospitals NHS Foundation Trust is able to create a change of practice in the Accident and Emergency departments locally and nationally. Enabling faster discharge of patients without compromising on patient safety.

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:

This is the largest RCT comparing two rapid diagnostic algorithms in the diagnosis of myocardial infarction. It will provide a concrete analysis of the safety of both pathways and will inform clinicians world wide of the benefits and potential draw backs of one algorithm over another. By getting this data Liverpool University Hospitals NHS Foundation Trust will be able to provide an adjudicated 30 day major adverse cardiac event rate for any participant presenting to anywhere in the country.

This RCT on completion will be submitted to peer review journals. The methodology protocol paper was recently accepted to the American Heart Journal for publication. The Controller will also submit abstracts for presentation at the European Society of Cardiology Conference in 2025. The results will inform later guidelines issued by the European and American Societies of Cardiology and is likely to inform NICE guidance. It will also guide the local practice of the Accident and Emergency departments in the local NHS hospital trust.

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.

Abbott Diagnostics has developed an Articifical Intelligence algorithm to predict the chance of a heart attack in those presenting to A+E with chest pain. Abbott Diagnostics will receive an anonymised data set from Liverpool University NHS Foundation Trust which consists of clinical research number, the timing of 1st blood sample and result, timing of the second blood sample and result and patient outcome (heart attack occurred or not).

Processing:

Liverpool University Hospitals NHS Foundation Trust will transfer data to NHS England.

The data will consist of identifying details NHS Number, Date of Birth and Study ID for the cohort to be linked with NHS England data.

NHS England will provide the relevant records from the HES APC dataset to Liverpool University Hospital NHS Foundation Trust. The Data will
• contain no direct identifying data items but will contain a unique person ID which can be used to link the Data with other record level data already held by the recipient

The Data will not be transferred to any other location.

The Data will be stored on servers at Liverpool University Hospital NHS foundation trust.

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).

The Data will not leave the UK at any time.

Remote processing will be from secure locations within the UK. The data will not leave the UK at any time.

Access is restricted to employees or agents of Liverpool University Hospital NHS Foundation Trust. who have authorisation from the Principal Investigator.

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

The aggregated information derived from the Data will be combined with aggregated data from the REDCAP database.

Researchers from the Liverpool University hospital NHS Foundation trust will analyse the Data for the purposes described above.

MR572 - Management of Ocular Melanoma — DARS-NIC-148321-ZPHJ3

Opt outs honoured: N, Yes (Excuses: Consent (Reasonable Expectation), Section 251 NHS Act 2006)

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC, Health and Social Care Act 2012 – s261(2)(c), Health and Social Care Act 2012 – s261(2)(c), Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.

Purposes: No (NHS Trust)

Sensitive: Sensitive, and Non Sensitive

When:DSA runs 2018-10 – 2021-08 2017.09 — 2024.10.

Access method: Ongoing, One-Off

Data-controller type: LIVERPOOL UNIVERSITY HOSPITALS NHS FOUNDATION 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 - Scottish NHS / Registration
  5. MRIS - Members and Postings Report
  6. Civil Registrations of Death

Type of data: Identifiable

Objectives:

No contact will be made with any individual(s) that could be identified from the information supplied, except as specified in the protocol and associated letters agreed between Royal Liverpool Hospital and NHS IC.

Any reports, papers or statistical tables that are published or released to other organisations will fully protect the identity of individuals in accordance with current NHS IC guidance.

Where there is doubt about the implications to a particular situation, the advice of the NHS IC will be sought. If subsequent to release, it appears possible that there is a risk of disclosure, the NHS IC will be informed immediately.

No attempt will be made to link the information supplied to any other data relating to identifiable individuals without the prior approval of the NHS IC. The prior agreement of the NHS IC will also be sought for any extension of this work beyond what was originally made known to the NHS IC, if it involves the use of data supplied or derived from that supplied by the NHS IC.

Yielded Benefits:

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

Expected Benefits:

In any future application, the applicant will be required to provide details of the expected benefits resulting from the study.

Outputs:

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

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

Processing:

Under this Agreement, the data may be securely stored but not otherwise processed. No new data will be provided by NHS Digital under this Agreement.

The study data, including data provided by NHS Digital under previous agreements, are currently held by the Royal Liverpool and Broadgreen University Hospitals NHS Trust. Under this interim extension all devices containing data will be securely locked away in a locked cabinet at the Royal Liverpool and Broadgreen University Hospitals NHS Trust storage address specified in this Agreement.

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

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

Investigation of Aneurysm Repair Decision Aid (ARDA) for Management of Abdominal Aortic Aneurysms: Safety Validation and Impact Assessment — DARS-NIC-170867-M5Q6W

Opt outs honoured: Yes - patient objections upheld, Yes (Excuses: Section 251 NHS Act 2006)

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

Purposes: No (NHS Trust)

Sensitive: Non Sensitive, and Non-Sensitive

When:DSA runs 2019-01 – 2022-01 2019.11 — 2019.11.

Access method: One-Off

Data-controller type: LIVERPOOL UNIVERSITY HOSPITALS NHS FOUNDATION TRUST

Sublicensing allowed: No

Datasets:

  1. Civil Registration - Deaths
  2. Civil Registration (Deaths) - Secondary Care Cut
  3. Civil Registrations of Death - Secondary Care Cut

Type of data: Anonymised - ICO Code Compliant

Objectives:

The Royal Liverpool and Broadgreen University Hospitals NHS Trust (RLBUHT) requires Civil Registry mortality data which has been linked to National Vascular Registry (NVR) data for the purpose of a research study which aims to (1) develop a clinical decision tool based on the Aneurysm Repair Decision Aid (ARDA) and (2) to validate ARDA using the data.

RLBUHT will be the sole Data Controller and the sole Data Processor.

Abdominal aortic aneurysm (AAA) is a ballooning of the main artery of the body. Aneurysms gradually grow in size until some of them burst (rupture), at which point 80% are fatal. Aneurysm rupture is responsible for around 6,000 deaths per year in the UK, approximately 2.5% of all deaths in men over the age of 65 years. Each year approximately 6,000 patients undergo aneurysm repair in the UK with the aim of preventing premature death due to rupture. Aneurysm repair, however, is a major operation with a risk of serious complications and death.

Whether or not a patient benefits from a planned AAA repair depends upon a balance between A) estimated survival of the patient if not for an aneurysm, B) risk of aneurysm rupture (if not repaired) that could be fatal, and C) the risk complications and death from the aneurysm repair. There is no practicable and consistent method of determining these factors for each patient in standard clinical practice. Therefore, in general, all patients with an aneurysm larger than 55 mm are considered for operation, and people with smaller aneurysms are simply observed with periodic scans. Such a "one size fits all" rule has the advantage of simplicity, but it is also generally accepted that a refined and personalised clinical decision process would serve patients and physicians better. Aneurysm Repair Decision Aid (ARDA) has been developed for this purpose.

ARDA (Aneurysm Repair Decision Aid) is an NIHR project which was developed to identify optimal timing of elective abdominal aortic aneurysm repair (AAA) to achieve optimum survival advantage for individual patients and to assess the cost-effectiveness of elective repair at a particular aneurysm diameter.

This allows a consistent and objective estimation of the pros and cons of operation for a patient, thus helping patients and surgeons decide on the best treatment strategy for individual patients. It is hoped ARDA will be useful in identifying which patients may benefit from repair even before an aneurysm reaches 55 mm in size and also who may be better served by observation despite having an aneurysm larger than 55 mm. This information would improve decision making for patients with aneurysms. However, ARDA has not been externally validated to be utilised in clinical practise.

The vascular research team at Royal Liverpool and Broadgreen University Hospitals NHS Trust (RLBUHT) aims to develop a clinical decision tool based on ARDA and to conduct external validation among AAA patients in the National Vascular Registry (NVR) and also to estimate the potential impact of routine utilisation of this tool upon vascular services.

The research will focus on two sets of patients: 1) Patients with aneurysms smaller than 55 mm, and 2) patients with aneurysms larger than 55 mm.
RLBUHT has designed an analysis to validate ARDA prediction model based on a retrospective analysis of patients registered in the National Vascular Registry (NVR) who underwent elective repair of an AAA in England and Wales between January 2012 and December 2015, who are over 18 and have not undergone previous aortic surgery. Based on the health data of these patients as held on the NVR, RLBUHT shall undertake survival analyses under a hypothetical scenario of each patient's management guided by ARDA. The patients will be divided into two cohorts, one in whom ARDA supports immediate elective AAA repair (ARDA-OP group) and the other in whom ARDA suggests continued observation or non-operative management (ARDA-BMT group) (BMT = Best medical therapy). RLBUHT intend to statistically compare estimated survival against observed survival in both groups of patients. This analysis requires medium / late-term survival information of these patients, which is not available from the NVR. Therefore, RLBUHT requires access to linked Civil Registry data (mortality data) for these patients through NHS Digital.

This study is being funded by Liverpool Vascular and Endovascular Services' (LiVES) Vascular Aneurysm research fund. LiVES is a service within the . The study is being conducted by researchers in the vascular unit of the Royal Liverpool and Broadgreen University Hospitals NHS Trust. RLBUHT has designed the data flow and data management in a least intrusive manner that does not require the research team to access identifiable patient information or sensitive data. RLBUHT are requesting record-level linkage of survival information sourced from NHS Digital civil registry data, with health data from the NVR sourced by Healthcare Quality Improvement Partnership (HQIP). This will be done by NHS Digital acting as a trusted-third-party and dates are truncated to month/year to achieve this.

This work is research in the public interest as it aims to improve care and clinical outcome for all patients who have an AAA, regardless of size, by providing a refined and personalised clinical decision-making process, serving patients and clinicians better.

RLBUHT has determined that there are no moral or ethical issues from dissemination of data for this purpose. NHS Digital will pseudonymise the data before it is disseminated and RLBUHT will therefore be compliant with the ICO's "Anonymisation: managing data protection risk" code of practice.

Expected Benefits:

This research will determine if the ARDA clinical decision tool can be utilised in clinical practice. This has a potential benefit for infra-renal AAA patients in the future as it will enable them to make an informed decision when it comes to the management of their aneurysm. Besides, it will identify the optimal timing of surgery for each patient to maximise survival and provide optimal clinical care. The economic evaluation suggested that using ARDA could be cost-effective compared to decision making solely by aneurysm size threshold. Once ARDA is externally validated, the cost effective measure will be discussed with health economic team.

ARDA clinical decision tool will be useful in identifying which patients may benefit from repair even before an aneurysm reaches 55 mm in size and also who may be better served by observation despite having an aneurysm larger than 55 mm.

The research project is anticipated to lead to a prospective national study to evaluate the impact of the ARDA-based clinical decision tool on the treatment of abdominal aortic aneurysms.

Royal Liverpool and Broadgreen University Hospitals NHS Trust envisage the publication of the result of this project by February 2020.

RLBUHT has appointed a Patient and Public involvement (PPI) group for the purpose of this project. The Chief Investigator and Co-Investigator met with this group to discuss the project and the accessibility of using patient identifiable data by the NHS digital. The PPI group had no objections regarding accessing patient identifiable data by NHS Digital and considered this project to be an excellent project that will produce a powerful decision tool which will help the patients understand the risk and benefit from the AAA repair and enable both the surgeons and the patients to make an inform decision. There are three representative patients in the PPI group and the RLBUHT will conduct regular meeting with them to provide them with an update of the project progress and results.

Outputs:

This study will determine if the clinical binary decision tool developed by RLBUHT can be used to externally validate ARDA for the management of abdominal aortic aneurysm for both surgeons and patients. As for any clinical risk predictive model, .external validation is essential for it to be utilised in clinical practise.

Once ARDA has been externally validated using the clinical binary decision tool, the findings will be submitted for presentation in the Vascular Society for Great Britain and Ireland Annual Scientific Meeting. The findings will also be submitted for publication in a reputable journal such as The Lancet, Journal of Vascular Surgery and European Journal of Vascular and Endovascular Surgery. In addition, the report will be forwarded to Health Research Authority.

This output will contribute to conducting a subsequent national prospective study utilising the binary decision tool in management of patient with abdominal aortic aneurysm which is necessary for this tool to be adopted in clinical practice.

All outputs will only contain data which is aggregated with small numbers suppressed in line with the HES Analysis Guide.

RLBUHT anticipate the results will be available for publication by 01/02/2020.

Processing:

This study is conducted by researchers in the Royal Liverpool and Broadgreen University Hospitals NHS Trust.

Data Sources:
1) The National Vascular Registry (NVR): Health data and postoperative death date
2) Civil registration data from NHS Digital.

Data flow will take the following steps:
1) Patients included in the NVR and identified to have undergone an elective AAA repair between 01/01/2012 and 31/12/2015, who are over 18 and have not undergone previous aortic surgery will be determined by HQIP's data processor and extracted;

2) Patient identifiable Health data extracted from NVR will include NHS number and date of birth;

3) HQIP's data processor will send the patient-identifiable NVR data (Study ID, NHS number and date of birth) to NHS Digital;

4) NHS Digital will link the NVR data to the Civil Registration data and will then remove all identifying personal information;

5) NHS Digital will pseudonymise the data and send a summary of death information (Date of death, truncated to mm/yyyy and cause of death code), with the Study ID directly to the Royal Liverpool University Hospital research team.

In addition, NVR will also create a pseudonymised dataset, including wider clinical information, using the same study ID and transfer this direct to the Royal Liverpool and Broadgreen University Hospitals NHS Trust. Royal Liverpool and Broadgreen University Hospitals NHS Trust would link both datasets via the study ID.

The combined pseudonymised data set will be securely stored for five years from the date of receiving the data, in line with research data policies set out by the Journal of Vascular Surgery and European Journal of Vascular and Endovascular surgery.

To clarify, NVR will not send any patient identifying data directly to RLBUHT. NHS Digital team will act as a trusted-third-party for linking NVR data with Civil Registration mortality data and pseudonymising the data. Steps therefore have been taken to mitigate the risk of any re-identification. The research study team will not share the data with any third party.

Data will be analysed by the research team in the RLBUHT. The data will be analysed and stored in a password protected electronic file in RLBUHT secured network. Access to this file will be further protected by hospital network log-in. Access will be restricted to the investigators only.

Following completion, the pseudonymised database will be transferred to the Chief Investigator and stored on his password-protected NHS computer, which is in a locked non-clinical area within the Royal Liverpool University Hospital.

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).

No data will be shared with third parties.

The Data will only be used for the purposes described in this Agreement.