NHS Digital Data Release Register - reformatted

University Of Leicester projects

• Improving physical health care in older people in mental health settings: The ImPreSs-Care Quantitative Study
• Trends and associations in mental and physical health: the Adult Psychiatric Morbidity Survey
• Cardio-oncology: A high resolution national electronic health record investigation of the interplay between cancer and heart disease
• MR1275 - The United Kingdom Aneurysm Growth Study
• Cancer survival methodological developments and their applications
• In silico trials of surgical interventions - using routinely collected data to model trial feasibility and design efficiency in vivo randomised controlled trials
• Modelling the transition from neonatal to paediatric care: a data linkage study
• Critically ill children and young people: do national Differences in access to Emergency Paediatric Intensive Care and care during Transport affect clinical outcomes and patient experience? The DEPICT study
• NAAASP Data Linkage
• Project 10

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

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Improving physical health care in older people in mental health settings: The ImPreSs-Care Quantitative Study — DARS-NIC-661742-Y2K8L

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 (Academic)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2024-05-20 — 2027-03-31

Access method: One-Off

Data-controller type: UNIVERSITY OF LEICESTER

Sublicensing allowed: No

Datasets:

1. Civil Registrations of Death - Secondary Care Cut
2. Community Services Data Set (CSDS)
3. Hospital Episode Statistics Admitted Patient Care (HES APC)
4. Mental Health Services Data Set (MHSDS)
5. National Diabetes Audit

Objectives:

The University of Leicester requires access to NHS England data for the purpose of the following research project: Improving physical health care in older people in mental health settings - The ImPreSs-Care Quantitative Study

The following is a summary of the aims of the research project provided by the University of Leicester:

"To provide contemporary information on the physical health needs, and their relationship with health outcomes for older people accessing mental health care in England.

"Primary objective: To determine the number and type of comorbidities experienced by older people receiving mental health care.

"Secondary objectives:
1. To determine the relationship between physical health comorbidities and outcomes in older people receiving mental health care.
2. To integrate data from a qualitative research project to determine recommendations for intervention and care delivery that can be tested in a future study
3. To identify areas for care optimisation, and targeted intervention to improve system processes and outcomes for patients"

The following NHS England Data will be accessed:
• Hospital Episode Statistics (HES) Admitted Patient Care (APC) – necessary to determine admission rates and reasons, physical health comorbidities
• Mental Health Services Data Set (MHSDS) – necessary to determine the population of interest, mental health diagnoses/presentation, admissions to the mental health trust
• Civil Registrations of Death Secondary Care Cut Data – necessary to determine the relationship between physical health comorbidities and frailty with risk of mortality
• National Diabetes Audit (NDA) – necessary to determine diagnosis of diabetes as a physical health comorbidity and calculate the Hospital Frailty Risk Score (HFRS)
• Community Services Dataset (CSDS) – to determine comorbidities not routinely found in other datasets to calculate the HFRS (e.g. hearing and vision impairment), and to improve comorbidity coverage

The level of the Data will be pseudonymised.

Several sensitive fields are required from the NDA as these are needed to determine physical and mental health comorbidities, to determine the comorbidity and/or frailty risk score, or adjust in statistical models. These fields will also enable the understanding whether the physical health comorbidity pre-dated the mental illness diagnosis or not.

Date of Death is required to calculate the 30-day mortality and survival post-discharge outcome. Underlying cause of death is required to analyse and understand the main physical health causes of death in this population.

The Data will be minimised as follows:
Limited to a study cohort identified by NHS England for individuals during the period from 1/4/2018 to 31/3/2023 who were aged 65+ years at the point of receiving HES APC care during that period. All data limited to that cohort will be disseminated to the University of Leicester.

On receipt, the University of Leicester will process the data to ensure that it is further restricted to only people receiving mental health care.

The Data of individuals not meeting this criteria will be destroyed and evidenced by a data destruction certificate.

The University of Leicester 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.

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 Van Geest Foundation Heart and Cardiovascular Diseases Research Fund and the Dunhill Medical trust. The funding is specifically for the study described.

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

Data will be accessed by:
• Individuals substantively employed with the University of Leicester.,
• Individuals with an honorary contract with the University of Leicester. – this is restricted to:
o A researcher substantively employed by London School of Economics (LSE) who will undertake analysis of the data and provide statistical expertise with data handling and analysis.
o A researcher substantively employed by the University of Barcelona (Spain) who will undertake analysis of the data and provide statistical expertise with data handling and analysis.
o A research assistant substantively employed by Age UK who will support the data analysis.

All honorary contracts (for the 3 individuals above (from LSE, University of Barcelona, Age UK) will adhere to the requirements of the relevant DAS data sharing standard.

A Public and Patient Information and Engagement group was consulted regarding the collection of the data for the purposes described above. The University of Leicester have consulted with patients and carers of people affected by combined physical and mental health problems who thought this project was worthwhile, beneficial and did not object to the use of pseudonymised data for this research purpose given the potential benefits to patients. The University of Leicester have a lay research team member who will be involved throughout the lifetime of the research project and will provide a patient carer perspective on the research conduct, interpretation, findings and dissemination.

The University of Leicester conduct regular, 6 monthly PPIE meetings for this project as part of the funding. PPIE members did not have any concerns about the data being used or the proposed processing and were supportive of the project to use the data to enhance knowledge in this area.

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.
• advance understanding of the need for, or effectiveness of, preventative health and care measures for particular populations or conditions such as frailty and mental health.
• 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 findings from this study will provide up-to-date information on the level of physical health comorbidity and frailty in older people receiving secondary mental health care in England. The data provided will allow The University of Leicester to determine the relationship of these variables to health outcomes for these patients. This information will be combined with qualitative data to help derive service recommendations to improve physical health care provision and access for patients with complex physical and mental health needs.

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 University of Leicester will engage with service commissioners and managers locally during the qualitative aspect of this project, and findings will be disseminated to these key stakeholders to help disseminate the findings and recommendations to the relevant people and inform service design and delivery in physical and mental health care integration.

The University of Leicester will also engage with third sector organisations such as Age UK and Mind to help improve the reach and dissemination of our study findings. The University of Leicester will share the findings on social medias and via community presentations.

Outputs:

The expected outputs of the processing will be:
• A report of findings to the van Geest Cardiovascular Foundation Heart and Cardiovascular Diseases Research Fund on an annual basis
• Submissions to peer reviewed journals within one-two years of completing data analyses
• Presentations to local clinical and research departments at the University of Leicester and affiliated hospitals
• Presentations at appropriate conferences relevant to geriatrics, mental health, cardiovascular disease

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
• Academic/scientific conferences
• Social media
• Community presentations to community groups and organisations
• Lay summaries to participants involved in the focus group and qualitative interview study

The target dates for production and dissemination of the outputs are expected within 1-2 years of analysing the data (January 2026).

Processing:

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

NHS England data will provide the relevant records from the MHSDS, HES APC, Civil Registration Death Secondary Care Cut Data, CSDS and NDA datasets to University of Leicester.

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.

The Data will be stored on servers at University of Leicester.

The Data will be backed-up on the Research drive (R:) on the University of Leicester server.

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).

The University of Barcelona analyst (under an honorary contract with the University of Leicester) will access the data remotely via the R drive at the University of Leicester.

Those under honorary contract will be required to adhere to the agreement between the University of Leicester and the honorary contract holder’s substantive employee.

Honorary contract holders are permitted to use their own devices provided they comply with the University of Leicester's policy on "Bring Your Own Device" and complete the University of Leicester’s data protection training prior to being given access to the data. Honorary Contract holders will access the data remotely via the University of Leicester’s secure VPN.

Remote processing will be from secure locations within the UK & EEA. The Data will not leave the England at any time.

Personnel will be prohibited from downloading or copying data to local devices.

Access is restricted to employees or agents of the University of Leicester who have authorisation from the Chief Investigator. Agents include those under honorary contract with the University of Leicester.

Specific individuals employed by the London School of Economics and the University of Barcelona respectively, under honorary contracts with the University of Leicester, will access the pseudonymised data to undertake analysis of the pseudonymised data on behalf of the University of Leicester and will provide statistical expertise with data handling and analysis.

The University of Loughborough will access analysed/aggregated data with small numbers suppressed to develop a discrete event simulation to model processes and pathways to improve service provision. The University of Loughborough will only access aggregated data (not raw data) with small number suppression rules applied for the purpose of modelling new care pathways and developing service recommendations derived from the integration of the analysed data with qualitative data collected separately.

The University of Nottingham will be collaborating with the University of Leicester in the interpretation of the findings, developing recommendations and write-up. The University of Nottingham will only access aggregated data (not raw data) with small numbers suppressed for the purpose of modelling new care pathways and developing service recommendations derived from the integration of the analysed data with qualitative data collected separately.

The aggregated data, anonymised with small numbers suppressed, will be combined with a qualitative data from a linked research project at the University of Leicester. The University of Leicester will collect qualitative data from a related research project and integrate the aggregated qualitative data with findings from this project with mixed methods. This will allow the University of Leicester to draw recommendations for future service development and design that will be reviewed by focus groups involving key stakeholders.

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

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

Analysts/researchers from the University of Leicester will process/analyse the data for the purposes described above.

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Trends and associations in mental and physical health: the Adult Psychiatric Morbidity Survey — DARS-NIC-177114-Y6W8J

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

Purposes: No (Academic)

Sensitive: Non-Sensitive

When:DSA runs 2019-06-01 — 2022-05-31

Access method: One-Off

Data-controller type: UNIVERSITY OF LEICESTER

Sublicensing allowed: No

Datasets:

1. Adult Psychiatric Morbidity Survey
2. Adult Psychiatric Morbidity Survey (APMS)

Objectives:

University of Leicester’s legal basis for processing personal data under GDPR is function of a public task (by a public organisation) as set out in Article 6(1), point (e) (“necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller”) and Article 9(2), point (j) (“necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes”).
The Psychiatric Morbidity Survey series provides key context for understanding mental illness in England and for informing initiatives in this area. The survey series has run since the early 1990s and covered a range of general population namely Adults living in private households: aged 16 to 64 in 1993, aged 16 to 74 in 2000, and 16 and over in 2007 and 2014.

The University of Leicester (UOL), Department of Health Sciences, are conducting a quantitative study with the overall aim of identifying the associations between Attention Deficit Hyperactivity Disorder (ADHD) with Autism Spectrum Disorder (ASD) and other psychiatric conditions, in the adult general population and additionally, the association of adult ADHD and ASD with possible risk and protective factors. In addition, the University of Leicester will use this data to validate an ADHD assessment (Schedules for Clinical Assessment in Neuropsychiatry (SCAN) ADHD tool) carried out during phase II of the study, using the Diagnostic Interview for ADHD in adults (DIVA) carried out during phase III of the APMS 2014 study. The study will utilise data from the Adult Psychiatric Morbidity Surveys (2014), a nationally representative survey of mental health, to analyse these associations.

The APMS 2014 data will also be utilised to update and continue an existing programme of studies to examine and understand national prevalence, trends and associations of mental and physical health conditions. This programme will continue an existing collaboration on the previous APMS datasets (1993-2007) with the APMS ‘writing group’, based at the National Centre for Social Research (NatCen). The programme is ongoing and will later incorporate APMS 2021 (the APMS survey is carried out every 7 years), subject to an amended application.

Furthermore, data will be utilised to analyse diabetes in Autistic adults. The study will utilise data from the Adult Psychiatric Morbidity Surveys (2014), a nationally representative survey of mental health, to analyse this association.

Access to the APMS 2014 data is also necessary in order to further develop and evaluate the data for future APMS surveys, with respect to mental health assessments.

Use of data from the 2014 APMS will be purely a secondary analysis of anonymised data with no attempts to link back to the original sample. Data will be used for the purpose of research only.

The University of Leicester will be the sole Data Controller and Processor. No other organisations are involved in the study

Expected Benefits:

Presentations at the conferences mentioned in the previous section will develop growth in clinical understanding in the areas and has the potential to initiate further research and collaboration.

December 2019: Data processing will provide a validation of an ADHD assessment (Schedules for Clinical Assessment in Neuropsychiatry (SCAN) ADHD tool). The outcome of such has the potential to improve care pathways and future assessment of ADHD in APMS surveys.

September 2020: Data processing will also provide new information for policy makers clinicians and the public on the prevalence of specific mental health conditions and risk factors.

June 2021: Data processing will provide new and unique information on trends in mental health, for use in health service planning, needs projection and health policy making.

Data processing will also provide new understanding of trends in health conditions and their association with context and risk factor (June 2021).

Data processing and subsequent outputs will provide growth in clinical understanding of Neurodevelopmental disorders.

Outputs:

December 2019: Validation of an ADHD assessment (Schedules for Clinical Assessment in Neuropsychiatry (SCAN) ADHD tool) carried out during phase II of the study, using the Diagnostic Interview for ADHD in adults (DIVA) carried out during phase III of the APMS 2014 study. Aggregated data will be used.

High profile peer-reviewed academic papers identifying the associations between Attention Deficit Hyperactivity Disorder (ADHD) with Autism Spectrum Disorder (ASD) and other psychiatric conditions, in the adult general population and additionally, the association of adult ADHD and ASD with possible risk and protective factors. (February 2020) Aggregated data will be used.

December 2019: High profile peer-reviewed academic paper identifying diabetes prevalence in people with Autism Spectrum Disorder (ASD). Aggregated data will be used.

December 2019: High profile peer-reviewed academic paper and press release on trends in mental health, for use in health service planning, needs projection and health policy making. Aggregated data will be used.

September 2020-June 2021: Further high-profile peer-reviewed academic papers on trends in mental health conditions and risk factors and their association with context and risk factors. Aggregated data will be used.

June 2019- March 2022: Aggregated data will be used in presentations and/or at conferences to illustrate any trends and/or associations found in mental health conditions.

The outputs listed above will be presented at one or more of the following conferences/meetings:-
• European Psychiatric Association - Congress of the Section of Epidemiology and Social Psychiatry
o This is an international conference attended by public health and mental health specialists, psychiatrists, clinicians and researchers.
• World Psychiatric Association (WPA) – section of Epidemiology and Public Health
o This is an international conference attended by public health and mental health specialists, psychiatrists, clinicians and researchers.
• International Federation of Psychiatric Epidemiology (IFPE)
o This is an international conference attended by public health and mental health specialists, psychiatrists, clinicians and researchers.
• The Royal College of Psychiatry Neurodevelopmental Special interest Group conference meetings (biannual)
o These meetings are attended by psychiatrists, mental health specialists and researchers with a particular interest in Neurodevelopmental disorders.
• Schedules for Clinical Assessment in Neuropsychiatry (SCAN) annual meetings
o These meetings are attended by international public health and mental health specialists, psychiatrists, clinicians and researchers.
• Local clinical presentations
o These are attended my fully trained clinicians and trainees in psychiatry.
• University presentations
o Internal presentations to university members, both students and staff.

In order to protect patient confidentiality in publications resulting from analysis of APMS data users must:

· guarantee that any outputs made available to anyone other than those with whom this agreement is made, will meet required standards, including the guarantee, methods and standards contained in the Code of Practice for Official Statistics (http://www.statisticsauthority.gov.uk/assessment/code-of-practice/index.html) and the ONS Statistical Disclosure Control (https://gss.civilservice.gov.uk/statistics/methodology-2/statistical-disclosure-control/) for tables produced from surveys;

· apply methods and standards specified in the Microdata Handling and Security Guide to Good Practice (http://www.data-archive.ac.uk/media/132701/UKDA171-SS-MicrodataHandling.pdf) for disclosure control for statistical outputs.

Processing:

Data with individual, non-identifiable records will be downloaded from the Economic and Social Data Service (ESDS) data archive and, kept at the University of Leicester (UOL), on a dedicated project space, on the designated research drive.

A secure VPN will be used to access the dedicated R: drive allocation where the data is held, by named University of Leicester employees, using University of Leicester managed encrypted laptops. This will include some off-campus working via the VPN. No data will be copied from the designated research drive.

Data will only be accessible by approved UOL research staff and will not be transferred to or shared with any other parties.

Names of those accessing the data will be kept by the University's Information Assurance Office to ensure compliance with e-Learning for Healthcare (E-LFh) training. The dataset will be included on the University's Information Assets Register.

Data will be analysed for nationally representative trends and associations using SPSS, SAS, R and STATA. Data analysis will be at an aggregate level, for population based trends in prevalence and statistical associations. Statistics will not be reported for cells numbering less than 30.

Use of data from the 2014 APMS will be purely a secondary analysis of anonymised data with no attempts to link back to the original sample.

Data will not be used for commercial purposes, will not be provided in record-level form to any third party, and will not be used for direct marketing.

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Cardio-oncology: A high resolution national electronic health record investigation of the interplay between cancer and heart disease — DARS-NIC-143888-H0W2N

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 (Academic)

Sensitive: Non-Sensitive

When:DSA runs 2019-06-01 — 2022-05-31

Access method: One-Off

Data-controller type: BARTS HEALTH NHS TRUST, PUBLIC HEALTH ENGLAND (PHE), UNIVERSITY OF LEICESTER

Sublicensing allowed: No

Datasets:

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

Expected Benefits:

The primary focus of the work is to use national health records to advance a paradigm shift in our understanding of the interactions between heart disease and cancer. The secondary focus is to establish an accepted route for similar data linkage proposals so that the full potential of Big Data analysis in the UK can be achieved whilst maintaining the highest standards of data governance.

Although multi-morbid patients account for the largest proportion of NHS clinical activity, this population are under-represented in current clinical research. Such patients are, for example, usually excluded from randomised controlled trials. Population research with data linkage holds huge potential for better understanding of best practice in the real world of multi-morbid poly-pharmaceutical patients.

This research has considerable potential to lead directly to patient benefit both by enhancing current treatment approaches, developing new clinical trials (e.g. database follow-up RRCTs) and by enabling the early characterisation of any cardio-oncological interactions arising from the new treatment strategies. For example chemotherapy induced cardio-myopathy, especially following anthracyclines, is well established. However, the large patient numbers generated by national level data, will enable information on longer term incidence, outcomes and likely NHS impacts to be probed. This will enable refinements in cancer treatment to reduce adverse cardiovascular sequelae to be monitored in near real-time and allow the investigation of the potential of early protective strategies.

Likewise, coronary artery disease following thoracic radiotherapy is established. However as radiotherapy regimes are refined, rolling contemporary data is needed with the power to quantify the remaining effect sizes in this population. Equally, whilst it is known that X-ray doses increase cancer risk, this programme will enable the long term effects of fluoroscopy doses from cardiovascular procedures to be determined and interactions, for example with age and sex, to be studied. The risk of specific procedures (such as chronic occlusion angioplasty) can also be investigated. Hence as survival rates improve, these data will allow refinement of current treatment strategies based on a broader understanding of overall longer term morbidity and mortality as well as the development of new protective approaches to prevent adverse long term treatment effects. It is thus anticipated that this programme will generate research outputs with considerable potential to lead to changes in clinical practice.

Specific benefits for the workpackages include:

Workpackage 1 - benefit patients with cancer who develop cardiovascular conditions and clinical teams who care for those patients by providing data on whether current management is optimal and investigating outcomes in patients with cardiovascular diseases.

Workpackage 2 - benefit patients with cardiovascular disease who develop cancer and the clinical teams who care for those patients by providing data on how these conditions and their treatment alter future cancer risks and modify cancer outcomes.

Workpackage 3 - benefit patients requiring treatment for cancer and the clinical teams who care for those patients by providing data on the long term cardiovascular sequelae of these treatments and giving indications on how these might be minimised.

Workpackage 4 - benefit patients with both cardiovascular disease and cancer and the clinical teams who care for those patients by investigating how the co-existence of these conditions affects current clinical management and identifying how this might be improved.

Outputs:

The national linked datasets generated for this proposed programme will represent the largest cardio-oncology analysis to date. As such the potential for high impact outputs is considerable. The study team includes key opinion leaders from both cardiovascular and cancer epidemiology as well as the nascent cardio-oncology community and is therefore well placed to ensure study findings are given prominence at national and international meetings (including the British Cardiovascular Society) in relevant specialty areas. Findings will be published in journals with open access. The Lay study representatives will support the generation of ‘Plain English’ summaries of key outputs which will be posted on the study website and those of the partner institutions to ensure wider public understanding of the programme findings.

The following outputs will be produced:
~ Reports of interim results will be provided to the British Heart Foundation/Cancer research UK every 6-months.
~ The final report of results will be submitted to the British Heart Foundation/Cancer Research UK in 5-years upon programme completion. This will cover all findings of the study including: factors influencing planning and implementation. Throughout the programme study findings will be published in the open access, peer-reviewed journal(s) with a Lay summary of findings produced by our Lay Executive Members for publication on the study website.
~ For [each/a specific] paper published, a short presentation is developed to summarise the findings for a range of stakeholders, including clinicians, academics and patients.
~ Findings will be presented at appropriate international conferences such as the British Thoracic Oncology Group (BTOG) and the British Cardiovascular Society, national meetings and patient and public involvement (PPI) and patient meetings.

Processing:

Patient objections will be reapplied to the data to be processed under this agreement, as it is being used for a new purpose. This will take place prior to any other processing under this agreement. Once the objections are applied to the data, the HES IDs will be provided to the University of Leicester. HES IDs are not identifiable. No analysis or comparison may be undertaken between the two datasets.

Step 1: Conducted by NICOR staff: NICOR data already linked to HES and mortality data (NIC_359940-W1R7B) for the purposes of audit would first be modified to encrypt dates of death so that these cannot be used for the purposes of identification. Dates pertaining to each patient will either be used to generate derived survival intervals and expanded to within 1 week or, offset by having a number of days (0-7) added or subtracted such that no date can be identified but intervals between dates can measured. The number of days added or subtracted would be random between patients to prevent decryption.

Step 2: Conducted by NICOR staff: NICOR data already linked to HES and mortality (NIC-359940-W1R7B) would be encrypted using the common SALT key such that identifiable information (NHS number and date of birth) are used to generate a pseudo ID.

Step 3: Conducted by PHE staff: In parallel, NCRAS staff will encrypt NCRAS data already linked to HES and mortality (NIC-343380-H5Q9K) using the same encryption algorithm such that identifiable information (NHS number and date of birth) are used to generate a common pseudo ID.

Step 4: Co-ordinated by NICOR and PHE staff: Pseudonymised NICOR data linked to HES and mortality is securely transferred into PHE.

Step 5: Conducted by PHE staff: The pseudo IDs from NICOR and NCRAS datasets (both already linked to HES and civil registration data) are merged to generate a common master patient index consisting of the pseudo IDs, the registries in which those IDs appear (i.e. the NICOR audits as listed above or the NCRAS audits as listed above) and a minimal demographic dataset (this will not include identifiable data such as date of birth).

Step 6: VICORI analysts will use the master patient index to identify cohorts pertaining to specific research questions pertaining to the workpackages. No other study personnel will have access to the pseudonymised data or master patient index. VICORI analysts will use the data dictionaries from NICOR, NCRAS and linked HES to identify the data fields required for their analysis. VICORI analysts will then extract a bespoke dataset specific to each research questions for the purposes of analysis. This pseudonymised bespoke data will then be shared on a limited access basis with the lead investigators at the academic partners named as data processors, below (specifically: University of Leicester, University of Leeds, University of Oxford, University of Birmingham, University College London, Royal Marsden Hospital NHS Trust, London School of Hygiene and Tropical Medicine and the Royal Brompton and Harefield NHS Trust).

This bespoke dataset will be maintained only for as long as it is required for analytical purposes.

The linked data resource will therefore be generated and maintained by NCRAS within Public Health England under the terms of the Data Sharing Agreement. Analysis will be conducted either on-site at PHE or by secure remote access (using the same current standard procedures for off-site remote secure working by NCRAS analysts) by VICORI analysts with appropriate PHE honorary contracts and permissions.

Once generated the pseudonymised linked data would be stored within PHE. Access to the pseudonymised data and Master Patient Index would be through permission of the Office for Data Release (ODR) by PHE employees or persons with a suitably robust PHE honorary contract either on site or by a suitable secure and approved remote access link (VPN) as agreed with ODR. This will constitute the VICORI analytical team. Data processors will receive bespoke deidentified data appropriate to the specific research questions on a limited access basis and subject to VICORI oversight committee and ODR approval.

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

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 attempt will be made to identify/re-identify anyone from the data once it has been pseudonymised.

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MR1275 - The United Kingdom Aneurysm Growth Study — DARS-NIC-148437-C9YSC

Type of data: information not disclosed for TRE projects

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

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)

Purposes: No (Academic)

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

When:DSA runs 2017-06-21 — 2020-02-28 2016.04 — 2024.06.

Access method: Ongoing, One-Off

Data-controller type: UNIVERSITY OF LEICESTER

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. Civil Registration - Deaths
6. Demographics
7. Hospital Episode Statistics Admitted Patient Care
8. Civil Registrations of Death
9. Hospital Episode Statistics Admitted Patient Care (HES APC)

Objectives:

This study aims to find out more about abdominal aortic aneurysms (AAA). This is a condition where the main artery in the body swells up and there is a risk of it bursting as a result. This kills approximately 10,000 people in England and Wales per year. These AAA can be found when they are small but it they get bigger there is no treatment for them other than high-risk surgery. Recently, a national screening programme has been started for AAA and through this programme, patients with AAA and those found not to have AAA will be recruited into this study. Study participants will have blood and urine samples taken at several time points as well being asked to fill in questionnaires about how they feel and their general health. Long-term follow up of the participants through the data retrieved from the MRIS will be used to determine mortality rates and causes in the study participants.

Yielded Benefits:

Expected Benefits:

The main benefit that will be derived from the addition of NHS Digital data as study outputs will be in the field of precision medicine. The combined UKAGS dataset (including cause of death) and bio resource will enable the examination of clinical and biological data taken at the time of AAA screening as predictors of future health in men. Whilst primarily focussed on AAA related events (rupture, cardiovascular events/mortality) the potential of such a resource to study other diseases is also important.

This resource needs to be established first to achieve this benefit. This work is currently in progress. Then a suitable length of follow-up time will need to be added to the resource (5-10 years). Once established, the resource can be used as the basis for additional funding applications to enhance the resource (e.g. with genomic data) and expand upon future utility of the resource.

The expected benefits of the UKAGS will not be made until after the initial recruitment period (after 2018). This was established with the funders of the study (primarily the British Heart Foundation) at the time of application for funding. Whilst immediate benefits are desirable in research, the long-term benefits of cohort studies has long been established.

The study expect the benefits of the UKAGS to be primarily in the clinical management of men with small AAA. Current knowledge of the best management for such men is poor. There is limited advice that clinicians can provide regarding how to prevent an AAA progressing and the UKAGS will provide such information. Beyond the management of AAA, UKAGS will identify if there are any high risk markers of future poor health that can be identified at AAA screening. These markers may be used in the future to target primary or secondary preventative strategies at any high-risk groups identified.

Each year around 500,000 men are screened for AAA in the UK and around 4000 AAA detected. Men with AAA will directly benefit from this research and a proportion of all men screened will benefit.

Additional benefit of receiving date of death report will be to enable the researcher not to cause distress /not to write to anyone who have died.

Outputs:

The recruitment phase of this study is now complete with the major outputs and benefits expected five to ten years from now. The following provides a summary of projected outputs and benefits. These may change depending on the results of the analysis.

The initial output will be the creation of a resource of clinical and biological data relating to abdominal aortic aneurysm through the conduct of a prospective cohort study. Electronic health data, including cause of death are a central component of the resource. This resource will be used by the University of Leicester to examine clinical and biological data taken at the time of AAA screening as predictors of future health in men.

Academic papers will be published in relevant journals that target clinicians on the growth and development of AAA in the immediate future (before 2020). Papers using cause of death as an outcome are not expected to be published until 5 years after recruitment is complete (2023). The most relevant journal for the publication for such outputs is the British Journal of Surgery, a journal where UKAGS outputs to date have already been published.

Other potential journals that will be considered are the Journal of Medical Screening and, if outputs have significant interest to the broader health community, the British Medical Journal or The Lancet.

A simplified version of the findings will be issued to participants in the form of the annual UKAGS newsletter which will also be published on the study website.

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

Processing:

Data for all study participants has been collected with consent.

No new data will be provided by NHS Digital under this Agreement.

The University of Leicester sent lists of study participants, who have consented in the study, to NHS Digital (via secure upload) for flagging. Details of new recruits were submitted periodically. The lists contained NHS number, date of birth, name and address. All pseudonymised study data is held separately to any identifiable data. Furthermore, NHS Digital data is held in a separate secure folder.

It is intended that the future Data Sharing Agreement will be amended to include linkage to Hospital Episode Statistics. This Agreement, however, relates to mortality data only.

The University of Leicester will store downloaded data within the UKAGS database. The data will be linked with the overall study dataset by study ID number. During the cohort recruitment phase (2011 to 2018) data obtained from NHS Digital was used solely to flag men who have died who should not be sent further study materials. The data will not be made available to any third parties. Data will be used for study outputs described in this Agreement. All outputs for dissemination will be aggregated outputs with small numbers suppressed in line with the HES Analysis Guide.

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 3rd parties. The Data will only be used for the purposes described in this agreement.

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Cancer survival methodological developments and their applications — DARS-NIC-662234-T6B7J

Type of data: information not disclosed for TRE projects

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

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

Purposes: No (Academic)

Sensitive: Non-Sensitive

When:DSA runs 2023-07-01 — 2026-06-30 2023.11 — 2023.11.

Access method: One-Off

Data-controller type: UNIVERSITY OF LEICESTER

Sublicensing allowed: No

Datasets:

1. NDRS Cancer Registrations
2. NDRS Quality of Life of Colorectal Cancer Survivors in England

Objectives:

The University of Leicester requires access to NHS England National Disease Registration Service (NDRS) Data for the purpose of the following research project: Cancer survival methodological developments and their applications.

The objectives of the project are as follows:
PRIMARY OBJECTIVES
1. Develop novel statistical approaches to report the impact of a cancer diagnosis at an individual level based on key patient characteristics both in terms of survival following a cancer diagnosis and in terms of quality of life.
2. Develop methodology in the same modelling frameworks to assess the impact of interventions (e.g., screening, and early diagnosis campaigns) or of the global pandemic due to COVID-19 (and corresponding restrictions) on the stage profile and outcome for cancer patients.
3. Develop approaches to better inform the impact of increased survival from new treatment interventions, by selecting nationally representative samples of patients, and using the developed methodology in survival curve extrapolation and marginalisation.

SECONDARY OBJECTIVES
1. Assess loss of life expectancy and loss of quality of life after cancer diagnosis for a range of cancer sites.
2. Estimate patterns of causes of mortality following a cancer diagnosis; and the long-term impact of a cancer diagnosis on other causes of mortality.
3. Provide long-term survival estimates according to the stage of cancer.
4. Estimate the impact of early diagnosis initiatives by calculating extrapolated stage-specific survival estimates assuming different underlying stage distributions.
5. Estimate the impact of achieving stage profiles of cancer patients in other countries by calculating stage-specific survival estimates assuming different underlying stage distributions.
6. Assessing the impact of pandemic-impacted lifetables on the estimation of cancer patient survival.
7. Using the excess mortality rate of cancer patients to assess the impact of the shift in timing and routes to diagnosis during 2020.
8. Create approaches to simulate nationally representative samples of cancer patients for given targeted populations for interventions, allowing tailored projections of treatment effects for a more realistic population.

As outlined above in the primary objectives the key reason for the data processing is to develop and show the benefit of the use of new statistical methods when using largescale population-level data such as that recorded as part of national cancer registration. These new methods will be widely used by applied researchers when assessing the impact of early diagnosis initiatives in cancer, understanding the impact of the pandemic on cancer outcomes, and assessing the benefit of novel cancer treatments when applied to the whole population (rather than isolated to a clinical trial population). The secondary objectives listed for the use of the data will also offer key exemplars of how these new methods can be applied to real-world data and offer key insights for cancer patients, clinicians and policy makers. This will aid future cancer research in utilising these key data resources.

The following NHS England NDRS data will be accessed in support of these aims:
• NDRS Cancer Registrations
• NDRS Quality of Life of Colorectal Cancer Survivors in England

The data being accessed will be record-level pseudonymised data.

The NDRS Cancer Registry data will be minimised as follows:
• The data requested will be limited to adults 18-99 (inclusive) who fall under specified ICD-10 Codes covering the following cancer sites/morphologies/behaviour: Colorectal, Bladder, Breast, Lung, Prostate, Hodgkin Lymphoma, Cervix, Stomach, Ovarian and Melanoma
• Data will be limited to patients diagnosed between January 1st 2000- December 31st 2020
• The data being requested will contain no exact dates, and be inclusive of year and month only
• Should a patient have more than one tumour for the same site only data relating to the tumour diagnosed first will be provided

The NDRS Quality of Life of Colorectal Cancer Survivors in England data will be minimised as follows:
• The data requested will be limited to adults 18-99 who have a diagnosis of colorectal cancer
• Only responses to questions that are necessary and relevant to the aims of the research have been requested

The University of Leicester has engaged in detailed conversations with the NDRS Analytical team to ensure that the data being requested is adequate, relevant and limited to what is necessary.

The University of Leicester will focus the majority of the outputs on the last 10 years of data. However, to estimate long-term survival estimates (i.e. life expectancy) there will be some added value in having up to 20 years of follow-up as a way to ensure that for cancer sites with long-term excess mortality the study team use the long-term data available to check if model-based estimates on the recent data are consistent to what has been observed in the past. The level of data could not be reduced without affecting the project's stated aims.

The University of Leicester is the sole controller and determines the purpose and means of processing for data being disseminated under this Agreement. The University of Leicester is responsible for ensuring that the data will only be processed for the purposes described above.

The lawful basis for processing personal data under the UK General Data Protection Regulation (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.

Funding for this project has been provided by Cancer Research UK. The funding is specifically for the project described within this Agreement. Cancer Research UK will have no ability to suppress or otherwise limit the publication of findings.

Individuals substantively employed by the Karolinska Instiutet, University College London (UCL) and the International Agency for Research on Cancer (IARC) act in an advisory capacity. These individuals have not been involved in determining the purpose and means of the processing and will not receive access to the data being provisioned under this Agreement.

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 (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:

Primarily the findings are expected to produce statistical methods that may help improve the validity of future health-related research focused on cancer survival. This in turn may contribute to evidence-based decision-making for policymakers, and healthcare professionals, and inform best practices to improve the care, treatment and experience of healthcare users.
The statistical methods being produced may help researchers:
• Improve understanding of regional and national trends in health and social care needs
• Inform planning of health services and programme
• Inform decisions on how to effectively allocate and evaluate funding according to health needs
It is hoped that through the publication of findings in appropriate media the statistical methods developed will add to a growing body of methods that can be used by researchers to carry out research on cancer survival.
Furthermore, the summary statistics produced may contribute to evidence-based decision-making for policy-makers, and local decision-makers such as doctors, and patients to inform best practices to improve the care, treatment and experience of healthcare users.
The findings will be advertised to a wide audience to ensure maximum impact. CRUK, the study’s funder, may assist in ensuring that the findings reach the relevant communities.

Outputs:

The expected outputs of the processing will be:
• Submissions to peer-reviewed journals, the study team plan to publish all statistical analysis code in peer-reviewed journals (e.g., Statistics in Medicine, International Journal of Cancer). The study team expect to be able to begin to make submissions at some point in 2024.
• Presentations at Conferences (e.g., the International Society for Clinical Biostatistics and the International Association of Cancer Registries Conference)
• The study team may look to create an interactive tool that provides summary statistics. Any such tool will be made publicly available and will be published on the University Webpages
The outputs will not contain any NHS England NDRS data and will only contain aggregated information with small numbers suppressed in line with the relevant disclosure rules.
The outputs will be communicated to the relevant recipients through the following dissemination channels:
• Journals
• Social Media
• Press/Media Engagement
The study team expect that outputs will be disseminated by the end of 2024.

Processing:

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

NHS England will provide the relevant records from the NDRS Cancer Registry and the NDRS PROMs (Colorectal) to the University of Leicester. The data will contain no direct identifying items, the data will be pseudonymised and individuals cannot be reidentified through linkage with other data in possession of the recipient.

Once the University of Leicester has received the data, the data will not be transferred to any other location.

The data will be stored on servers at the University of Leicester. Backup servers are located on-site.

The data will be accessed by authorised personnel via remote access on University equipment only and only via a secure VPN. The data will always remain on the servers at the University of Leicester.

The data will not leave or be accessed outside of England and Wales at any time.

Access is restricted to substantive employees of the University of Leicester who have authorisation from the Principal Investigator. All those accessing the data have been appropriately trained in data protection and confidentiality.

The data that is being provided under this Agreement will not be linked to any other data. While the study has access to data provided by the Clinical Practice Research Datalink (CPRD) there is no mechanism through which this data can be linked or pooled with data received from NHS England.

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

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

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In silico trials of surgical interventions - using routinely collected data to model trial feasibility and design efficiency in vivo randomised controlled trials — DARS-NIC-262908-X5F4Q

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: 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 (Academic)

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

When:DSA runs 2020-08-01 — 2023-07-31 2020.12 — 2023.07.

Access method: One-Off, Ongoing

Data-controller type: UNIVERSITY OF LEICESTER

Sublicensing allowed: No

Datasets:

1. Hospital Episode Statistics Critical Care
2. HES:Civil Registration (Deaths) bridge
3. Hospital Episode Statistics Outpatients
4. Hospital Episode Statistics Admitted Patient Care
5. Civil Registration - Deaths
6. Hospital Episode Statistics Accident and Emergency
7. Diagnostic Imaging Dataset
8. Bridge file: Hospital Episode Statistics to Diagnostic Imaging Dataset
9. Civil Registration (Deaths) - Secondary Care Cut
10. Emergency Care Data Set (ECDS)
11. HES-ID to MPS-ID HES Accident and Emergency
12. HES-ID to MPS-ID HES Admitted Patient Care
13. HES-ID to MPS-ID HES Outpatients
14. Civil Registrations of Death - Secondary Care Cut
15. Diagnostic Imaging Data Set (DID)
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:

This study will be undertaken by the Leicester Cardiac Surgery Research Group at Department of Cardiovascular Sciences based in the University of Leicester. This study is to establish a database of patients with cardiovascular diagnosis in England using routinely collected clinical and mortality data obtained from NHS Digital. This database will be used to model trials of surgical interventions in silico and devise a set of pragmatic trial proposals to address the priority research questions in cardiac surgery.

HES DATA
The gold standard for the evaluation of medical treatment is through randomised controlled trials. However, the successful delivery of clinical trials are often limited by the many assumptions that are required for design and planning. Assumptions are often made with respect to recruitment, eligibility, event rates, effect estimates, safety and attrition in real world populations. Hospital Episode Statistics (HES) data contains a wealth of real-world data including demographics, diagnoses, procedures and other clinical information collected prospectively from all NHS hospitals. This routinely collected clinical data enables the University of Leicester to explore the effect of interventions (e.g. open heart vs minimally invasive heart surgery) in a population and across different patient subgroups (e.g. elderly patients, or patients with other medical conditions), and obtain the necessary parameters required for designing a clinical trial. The University of Leicester may also optimize the trial design through sensitivity analyses of the inclusion/exclusion criteria of patient populations and definition of clinical outcomes. Applications of electronic health records to estimate trial outcomes and assess trial feasibility have been reported (Longo 2003, Doods 2014, Mc Cord 2018).

In this project, the University of Leicester propose to use HES data to obtain the granular data required for designing clinical trials assessing trial feasibility, thus minimizing the assumptions imputed and making the process quicker, simpler and more reliable. The University of Leicester will model pragmatic trials of surgical interventions in silico that will, in turn, be used to inform commissioning and funding applications for randomised clinical trials in NHS hospitals.

James Lind Alliance (JLA) Priority Setting Partnership (PSP) in Adult Heart Surgery

The Heart Surgery Priority Setting Partnership (PSP) is a collaboration between the Department of Cardiovascular Sciences at the University of Leicester and the James Lind Alliance (JLA). The JLA is a National Institute for Health Research (NIHR) initiative that aims to bring patients, carers and healthcare professionals together to identify and prioritise top unanswered health research questions. The University of Leicester propose to use HES data to design clinical trials in silico, assess trial feasibility, and devise a set of trial proposals to address the priority research questions identified in the JLA Heart Surgery PSP. The PSP has identified over 40 research questions covering different aspects of cardiac surgery, and the Top 10 research questions identified are:

1. How does a patient’s quality of life (QOL) change (e.g. disability-free survival) following heart surgery and what factors are associated with this?
2. How can we address frailty and improve the management of frail patients in heart surgery?
3. How can we improve the outcomes of heart surgery patients with chronic conditions (obesity, diabetes, hypertension, renal failure, autoimmune diseases etc.)?
4. Does prehabilitation (a programme of nutritional, exercise and psychological interventions before surgery) benefit heart surgery patients?
5. When should heart valve intervention occur for patients without symptoms?
6. How does minimally invasive heart surgery compare to traditional open surgery?
7. How do we minimise damage to organs from the heart-lung machine/heart surgery (heart, kidney, lung, brain and gut)?
8. Can we use 3D bio printing or stem cell technology to create living tissues (heart valves/heart) and repair failing hearts (myocardial regeneration)?
9. What are the most effective ways of preventing and treating postoperative atrial fibrillation?
10.How do we reduce and manage infections after heart surgery including surgical site/sternal wound infection and pneumonia?
Please note: these questions are official wording sources from JLA Heart Surgery PSP.


STUDY OBJECTIVES
The primary objective of this project is to use routinely collected HES and the linked mortality data to model trials of surgical interventions in silico and devise a set of pragmatic trial proposals to address the national priority research priorities in cardiac surgery.

The secondary objectives are:
• To evaluate the extent to which in silico trials can be conducted using HES data to design new trials.
• To establish methodologies and a systematic framework to carry out trials in silico with HES data so that trial feasibility can be conducted quickly and cost-effectively for a range of research questions.
• To develop capacity in processing and analyzing real-world clinical data using statistical and machine learning methods.
• To gain insights into how we might use HES data sets to support data collection and undertake future pragmatic trials.


REQUESTED DATA
Adult patients (18 years and above) with a cardiovascular diagnosis (ICD10 I00-I99, whether primary or secondary diagnoses) in HES Admitted Patient Care (APC) will form the reference cohort. Request for all HES and Civil Registrations - Deaths data sets are confined to patients identified in the reference cohort. Cumulative reference cohort will be used for annual update. The University of Leicester are requesting the data sets for the past 10 years plus an annual update for the next 3 years. An addition of two earlier years is also requested for HES APC for the purpose of new case ascertainment and defining patients’ co-morbidities and frailty score.

1) HES Admitted Patient Care (APC) AR 2007/08 to AR 2018/19 plus annual update to 2021/22
2) HES Critical care (CC) AR 2009/10 to AR 2018/19 plus annual update to 2021/22
3) HES Accident and Emergency (AE) AR 2009/10 to 2019/20 M12
4) ECDS AR 2020/21 to AR 2021/22.
5) HES Outpatient (OP) AR 2009/10 to AR 2018/19 plus annual update to 2021/22
6) Civil Registrations - Deaths data 2007/08 to 2018/19 plus annual update to 2021/22
7) Diagnostic imaging data sets (DID) 2007/08 to 2018/19 plus annual update to 2021/22

COHORT
The estimated size of the reference cohort is roughly 1.5 million admissions a year. The University of Leicester project team recognises that this is a large cohort size but will use the requested data to model trial in-silico and address the priority research questions in cardiac surgery identified by the James Lind Alliance process.

It is important to recognise that the James Lind Alliance process provides a set of priorities for research agenda which could be translated into future clinical trials. These research questions represent the areas that are important to those affected by cardiac surgery but are not precisely-worded that can be shared immediately with research funders. Further work is required to translate the research priorities into specific potential researchable questions for research funders to work with. For example, priority 3 ‘How can we improve the outcomes of heart surgery patients with chronic conditions?’, this question can potentially lead to specific research questions like (a) does pre-surgery optimisation of chronic conditions reduce post-operative lung and kidney injury or infection? (b) does minimally invasive approach improve outcomes in patients with chronic diseases? (c) are there specific pre-surgery interventions that can be targeted to patients with specific chronic diseases (e.g. weight loss programme for obese patients, glucose control for diabetic patients, iron supplement for anaemic patients)? Also, some specific question can address more than one research priority, for example, the question “does minimally invasive approach improve outcomes in patients with chronic conditions?” addresses two research priorities in relation to improving outcomes in patients with chronic conditions (priority 3) and minimally invasive cardiac approach (priority 6).

As well as strategic partnership with research groups to facilitate question formulation, the University of Leicester, in collaboration with Cochrane Heart, will commission a series of systematic reviews of the priority research questions to identify the knowledge gaps that can be addressed by clinical trials. In addition, the University of Leicester is organising a one-day Clinical Research Priorities Workshop to pump prime potential research teams who can come together to develop high quality research proposals for research funders. The workshop will bring together patients, carers, and a critical mass of expertise including clinicians, methodologists and scientists from across the UK to form interdisciplinary working groups and identify important trial questions from the research priorities. This Workshop was initially scheduled for July 2020 but has been postponed to early next year due to the Coronavirus pandemic.

In this project, the population of interests are adult patients with cardiovascular diseases who require or potentially require cardiac surgery. Cardiac surgery is performed to fix problems in the heart. It is used to treat a wide variety of cardiovascular diseases including aortic disease, arrhythmia, heart failure, coronary heart disease, cardiomyopathy, valvular heart disease, etc. Sometimes these problems can be addressed with medications or non-surgical procedures. For example, coronary angioplasty is a minimally invasive procedure in which a stent is inserted into a narrowed or blocked coronary artery. There are many types of heart surgery, some of the most common ones include coronary valvular surgery, aortic surgery, arrhythmia surgery, coronary artery bypass graft (CABG) surgery. The identified research questions cover all types of cardiac surgery and encompass all aspects of surgery from pre-operative assessment and risk stratification, to intraoperative management and post-operative outcomes.

The University of Leicester requests hospital admissions (HES APC) from adult patients with cardiovascular diagnoses. The requested data will be used to model a variety of cardiac surgery trials, and the analyses involved are board ranging. The analyses will not be limited to cardiac surgery patients, as it is also imperative to examine the effectiveness of surgical treatment by comparing the outcomes of cardiovascular patients with surgical and non-surgical interventions. For example, the research team is interested in developing trials examining the risks and benefits of CABG bypass surgery vs non-surgical angioplasty in heart failure patients. By limiting the patient cohort to patients who had cardiac surgery would limit the usefulness of the data. It is also not feasible to produce an exhaustive list of diagnosis codes that the cardiac surgery is used for. Therefore, although the focus of this study is cardiac surgery, the study requires a boarder cardiovascular cohort to define the patient population. It is important to note that although the HES APC data is termed the reference cohort, it will be used not only to define the patient populations but also to identify post-operative outcomes which include a wide range of cardiovascular conditions such as stroke, myocardial infarction, atrial fibrillation, in the trial modelling. In addition, the exact research questions for cardiac surgery are still being developed through the Cochrane review and the Clinical Research Priorities Workshop, it is necessary to ensure the requested hospital data covers all cardiovascular conditions so that the design of trials would not be limited by a predefined set of diagnoses.

The University of Leicester also requests hospital admissions within two years prior to the cardiovascular admissions, this data is required to check for patients’ frailty score and co-morbid conditions. These prior hospital episodes need to include ICD codes beyond the cardiovascular codes because the derivation of comorbidity and frailty scores such as Hospital Frailty Risk Score (Gilbert 2018) and Charlson Comorbidity Index (Li 2008) require a board range of diagnoses including both cardiovascular and non-cardiovascular codes. In addition, two of the research priorities identified are related to frailty (priority 2) and patients with chronic conditions (priority 3). Frail patients are often elderly patients with multiple medical conditions. Frailty is currently poorly defined for cardiac surgery. It would be desirable to examine if specific set of ICD codes could be identified to define frailty for cardiac surgery. By limiting our study to only pre-specified comorbid conditions, it would limit the usefulness and ability of the study to inform future cardiac surgery trials.

This project requires adult data defined by patients aged 18 and above, in line with the scope of the James Lind Alliance Priority Setting Partnership for Heart Surgery. Children data are not needed.

The University of Leicester requests national data as this project targets at designing multi-centre pragmatic trials to evaluate clinical effectiveness in a real-world setting. Access to and outcomes of cardiac surgery vary across geographical regions. Such variations may reflect difference in patient case-mix, centralisation of care into specialist hospitals, variation in practices, and other factors. By limiting the analysis to specific geographical regions would affect the generalisable of the findings in multiple settings. It is also important to recognise that certain heart operations such as the Ross procedure, Transcatheter aortic valve implantation (TAVI) are only practised by limited heart centres in the UK. In addition, an important part of the analysis is to enable a detailed understanding of the characteristics of patient populations and the estimation of treatment effects across patient groups stratified by age, comorbid conditions or frailty thus enabling the identification of targeted populations for specific interventions. Large volume national level data is therefore needed to ensure sufficient patient size to carry out sub-group analysis.

The University of Leicester requests various HES datasets and Civil Registrations – Deaths data to evaluate short (in hospital, within 1 month), medium (3-6 months) and long term (1 to 5 years) outcomes of cardiac surgery patients. Cardiac surgery is a complex operation with all heart surgery patients requiring intensive care support immediately after the surgery. It is necessary to include organ support data in critical care (HES CC) and post-op complications and in-hospital mortality in the index episodes (HES APC) to evaluate the short-term outcomes of patients after surgery. Also, HES APC datasets will be longitudinally linked to track short to medium term outcomes including readmission due to cardiovascular causes and repeat of heart operation. Together with the HES A&E data, unplanned readmissions could be identified which could serve as an indicator of adverse outcomes post surgery. The request of Civil registration mortality data will enable the project team to undertake survival analysis and evaluate patients’ survival in short, medium and long term basis. The project team is planning to track the outcomes within 5 years after surgery as long term outcomes. Most of the existing clinical trials have focused on reporting short terms outcomes. Data on long term outcomes are lacking, although this is important to determine the comparative effectiveness of different surgical and non-surgical interventions. The University of Leicester requests 10 years of patient data in the initial cohort, and this will provide 5 years of data with long term outcome measures.

In addition to clinical outcomes, this study will include analysis to evaluate healthcare resource use following an intervention. As well as the extraction of resources use data during the index admission, post-discharge healthcare use data will be obtained on hospital readmissions, visits to Accident and Emergency, outpatient attendances, and imaging tests. Resources including length of hospital stay and various levels of care after surgery will be obtained with HES APC. As all heart surgery patients need to be followed up in outpatient clinics post discharge and cardiac imaging such as echocardiography and cardiovascular magnetic resonance are used to assess cardiovascular function after cardiac surgery, it is necessary to include HES outpatient (OP) and imaging (DID) data sets as part of the outcome analysis. Also, HES A&E data is needed to identify unplanned medical visits as indication of healthcare resource use resulting from post surgery complications.

In summary, patient population, identified by the index episodes receiving the relevant surgical /procedural interventions, along with their baseline patient characteristics (demographics, co-morbid conditions, frailty scores, etc) will first be defined using HES APC. Short term outcomes including post-operative complications and in-hospital mortality would be tracked using HES CC and APC. Medium term healthcare resource use following the surgical intervention will be tracked with HES AE, OP and DID data sets. Long term outcomes including 1-year and 5-year survival will be tracked using Civil Registrations - Deaths data. The University of Leicester has considered data minimisation to ensure the data requested is justified and limited to the study objectives.


The requested HES data sets will be individual records and pseudonymised with unique identifiers generated by NHS Digital. No identifiable data (name, address, NHS number, etc) will be included in the data sets. Civil Registrations - Deaths, and DIDs data sets are linked to the HES data sets through bridging files. HES data set will be longitudinally linked through the pseudo identifiers. All the analyses will be carried out within the data sets requested in this application. There will be no linking of these data sets to any external data sets.

The University of Leicester is the sole data controller and will process the data for this project. No data processing will be carried out by other organisations. The project team will share and discuss the results in form of summary statistics with the collaborators. No data processing would be undertaken by them and all decisions about the data analysis would remain with the university. James Lind Alliance is not involved in this project. However, the University will feedback to James Lind Alliance for any successfully funded trials resulting from the work of this project.

PATIENT AND PUBLIC INVOLVEMENT (PPI)
The University of Leicester will engage with patients and the public for dissemination and communication of the main findings. This will be facilitated through the established Patient and Public Involvement (PPI) networks with the Leicester Cardiac Surgery Research Group and the Heart Surgery Priority Setting Partnership Steering Committee. Through the involvement and recommendations regarding the dissemination of findings by the PPI groups, this will ensure the outputs are interpret-able to the wider patient and public community.

LEGAL BASIS
This project is managed by the University of Leicester and will be conducted in accordance with all applicable regulatory guidelines. The University of Leicester will lawfully be processing personal data on the basis of GDPR Article 6.1(e) - the processing is necessary for the performance of a task in the public interest. Research is a task that the University of Leicester performs in the public interest, as part of the core functions as a university.

This project will involve processing data related to patients’ ethnicity (there are marked ethnic differences in risk of cardiovascular diseases). The University will lawfully be processing special categories of personal data on the basis of GDPR Article 9.2(j) - the processing is necessary for research purposes or statistical purposes. We will be processing pseudonymised data and the data sets will be stored and processed in accordance with the University Information Security Policy, College of Life Sciences Information Governance Policy, General Data Protection Regulation (GDPR) (EU) 2016/679 and the UK Data Protection Act (2018).

REFERENCES
1/ Longo et al. Can randomised trials rely on existing electronic data? A feasibility study to explore the value of routine data in health technology assessment. Health Technol Assess. 2003;7(26):iii, v-x, 1-117.
2/ Doods et al. A European inventory of common electronic health record data elements for clinical trial feasibility. Trials. 2014 Jan 10; 15:18.
3/ Mc Cord et al. Routinely collected data for randomized trials: promises, barriers, and implications. Trials. 2018 Jan 11;19(1):29.
4/ Gilbert et al. Development and validation of a Hospital Frailty Risk Score focusing on older people in acute care settings using electronic hospital records: an observational study. Lancet. 2018 May 5;391(10132):1775-1782.
5/ Li et al. Risk adjustment performance of Charlson and Elixhauser comorbidities in ICD-9 and ICD-10 administrative databases. BMC Health Serv Res. 2008 Jan 14;8:12.

Expected Benefits:

Approximately 35,000 adult cardiac procedures are carried out in the UK each year. The national research priorities for cardiac surgery have been identified through a vigorous and transparent James Lind Alliance (JLA) process and collectively agreed by patients, carers and healthcare professionals. The University of Leicester propose to use HES routinely collected clinical data to model trial in-silico and assess trial feasibility. The outcomes will lead to the production of a portfolio of cardiac surgery trial proposals to address those important research questions. It is anticipated that these trial proposals will attract research funding from UK National Institute for Health Research (NIHR) and British Heart Foundation (BHF) to the University of Leicester. More importantly, the eventual implementation of these trials could lead to improved clinical care and outcomes for heart surgery patients.

One of the key outputs of this project is a master protocol/methodological paper that will describe the methods, strengths and limitations of conducting in-silico trials using HES data. The in-silico approach could potentially shorten the research cycle from proof of concept to implementation of the trial, and set as a new benchmark in clinical trial design. By using HES data to obtain the granular data required for designing a trial and assess its feasibility, it can make the design of clinical trials quicker, simpler and more reliable. In addition, the in-silico approach can inform the subsequent data analysis plan of the trials designed on this basis. Concerns as to the event distributions over time, length of follow-up and so on can be addressed at the trial design phase. Also, it is anticipated that the in-silico approach developed using cardiac surgery will be adaptable across surgical disciplines. The University of Leicester will engage with key research funders to promote the initiative of in-silico trial as a key element for the rationale and justification of trial funding. The University of Leicester will share the methodology and promote the initiative with researchers of interests via workshop and academic channels (publications, academic conferences).

There is an increased emphasis on using routinely collected data to answer clinical and research questions. The in-silico trial initiative aligns with the research strategies of NIHR, the BHF Health Data Science Centre and the NHS DigiTrial - The Health Data Research Hub for Clinical Trials to increase the use of routinely collected HES data in supporting planning and delivery of pragmatic clinical trials. The dissemination of the in-silico methods will be undertaken in collaboration with the following professional bodies and research partnerships:

1. The Society for cardiothoracic Surgery in Great Britain and Ireland
2. The UK Clinical Research Collaboration (UKCRC) Clinical Trials Network
3. The British Heart Foundation (BHF) Health Data Science Centre
4. The UK National Institute for Health Research (NIHR) BHF Cardiovascular Partnership
5. The Royal College of Surgeons of England Clinical Trials Initiative.

In addition to the output of trial parameters using HES, this work will provide a platform to identify unmet needs and areas for further research and development. An example is the use of linked electronic health records and other routinely collected primary and secondary care data in pragmatic clinical trials. This is one of the strategic aims of the new BHF Health Data Science Centre of which the Chief Investigator is a member of the steering committee. Throughout the analysis, the project team will identify the outcome measures that are unable to be obtained from the NHS Digital HES data and propose how these might be addressed using remote data capture of electronic health records, smart phone data capture or other data capture methods.

The proposed digital tool for designing trials of cardiovascular diseases, intended to be put in a public domain, will enable any researchers interested in surgical research to plan for their cardiac surgery trials.

This project has also an additional benefit of educational training - the research team has a member of staff who is doing a part-time PhD, and will be trained in biostatistics, machine learning and clinical trial design using the data.

Outputs:

The University of Leicester will use the data for the research purposes specified in the application. This project will set out a methodological framework for conducting in silico trials using routinely collected HES and the linked death data. The work will provide granular data required for designing surgical trials and lead to the production of a portfolio of pragmatic trial proposals addressing the top priorities research questions in heart surgery.

The project team will first work on two candidate trials, which have been selected so that the strengths and the weaknesses of the in-silico trials approach can be identified. The two trials are:

1. Benefits of re-vascularisation (bypass surgery vs minimally invasive angioplasty) in heart failure patients – this work will model the comparative effectiveness of bypass surgery vs angioplasty in people with heart failure (a chronic condition) and coronary artery disease. The trial will address research priorities including improving outcomes in patients with chronic conditions (priority 3) and comparative effectiveness of minimally invasive vs open surgery (priority 6).

2. Benefits of stratification of re-vascularisation decisions based on objective measures of frailty - this work will model a trial to test the hypothesis that treatment decisions stratified by frailty are likely to result in improved long-term benefits. The trial will address improving outcomes of heart surgery patients in relation to long-term quality of life outcome (priority 1), frailty (priority 2) and minimally invasive vs open surgery (priority 6).

As well as the outputs for these two trials, this work will facilitate the development of the in-silico methodological framework and contribute to the production of a master protocol that will describe the methods, strengths and limitations of conducting in-silico trials using HES data.

The project team will work on modelling other trials in-silico when the exact research questions are formulated after the Cochrane review and the Clinical Research Priorities Workshop.

Trial proposals, funding applications and all research reports and presentations resulting from this project will contain only summary aggregated data with small numbers suppressed in line with the NHS Digital HES Analysis Guide. Research presentations may consist of oral presentations, poster and published abstract.

Scientific findings will be disseminated by usual academic channels, i.e. presentation at academic conferences and publication in peer-reviewed journals. No identifiable information will be presented.

The James Lind Alliance Priority Setting Partnership in Heart Surgery identified over 40 research questions covering different aspects of cardiac surgery. The priority will be given to address the top 10 questions, but it is important to recognise that some of the remaining questions are also important research questions. These include geographical variation in outcomes of heart surgery. The project team will use an observational study design to examine the short and long term outcomes of heart surgery patients by geographical regions and the factors associating with the variations. Peer reviewed scientific publications will be produced from analysing the data.

Proposed digital tool for designing trials of cardiovascular diseases
The University of Leicester Cardiac Surgery Research Group is planning to develop a web-based digital tool to support the planning of clinical trials in cardiac surgery. The tool is to be a web-based interactive tool to display the data summary and analyses that the University of Leicester Cardiac Surgery Research Group do for the research questions. The tool would keep multidimensional databases (in the same vein as an online analytical processing (OLAP) cube. An OLAP cube is a computer-based technique of analyzing data to look for insights. The term cube here refers to a multi-dimensional data set) for important trial parameters like patient numbers, outcome events stratified by dimensions including surgery/intervention, patient age and sex, frailty score, geographical region, etc that the users are able to be specified. Users will be asked to select/enter the targeted patient population (based on age, diagnosis, medical conditions etc), geographical region, the intervention, the comparator, trial design, primary outcome. The digital tool will then output the trial parameters including the occurrence of the primary outcome, expected treatment effect, sample size required, availability of patient populations by hospital etc. The tool will also help users to explore the trial parameters for different patient groups.

The tool is intended to be put in a public domain, to be used by UK healthcare professionals and researchers inside and outside the University of Leicester. The tool is a web application accessible via a web address. The data will sit on a secure server owned by the University of Leicester. With respect to access control, users need to register and login to gain access to the tool.

The tool will make no attempt to link NHS Digital data with any other data sets. All outputs are aggregated statistics with small number suppressed as per the HES guide.

Target dates for outputs:
Short term (1 - 2 year) - a methodological paper or a master protocol that will describe the methods, strengths and limitations of an in-silico trial approach;
Medium term (2 - 5 years) - a series of pragmatic trial proposals, including the two candidate trials, that answer the priority research questions identified by JLA Priority Setting Partnership in Heart Surgery.

Processing:

NHS Digital will extract:
1. HES APC: hospital admissions with cardiovascular diagnoses (primary or secondary) ICD10 I00-I99 (cardiovascular episodes), and this will form the basis of reference cohort.
2. HES APC: all hospital admissions including those with and without cardiovascular diagnoses in the two years preceding for each admission identified in (1)
3. HES Critical care (CC): ICU admissions linked to the cardiovascular episodes identified in (1)
4. HES Accident and Emergency (AE): all AE records of patients in the reference cohort
5. ECDS : all AE records of patients in the reference cohort
6. HES Outpatient (OP): all Outpatient records of patients in the reference cohort
7. Diagnostic imaging data sets (DID): all imaging records of patients in the reference cohort
8. Civil Registrations - Deaths data: mortality records of patients in the reference cohort

In the first extraction for 2009/10 – 2018/19, Data set (1), which includes all cardiovascular episodes during the extraction period, will form the reference cohort for extraction of other data sets.
In subsequent annual updates, the cumulative data set (1) will form the reference cohort for data extraction.

For Data set (2), the University of Leicester would like to know all cardiovascular and non-cardiovascular diagnoses during the 2 years prior to the cardiovascular episodes. Say a patient has a cardiovascular episode identified in June 2008, the University of Leicester would like to have all his/her cardiovascular and non-cardiovascular diagnoses from June 2006 to June 2008. Also, data set (2) will be needed not only for first time diagnosis, but for all cardiovascular episodes. For example, if a patient had undergone angioplasty in May 2008 and a heart bypass surgery in Dec 2018. A study on minimally invasive technique may use the angioplasty episode in May 2008 to form the study cohort, and the patient’s co-morbidity and frailty score will be determined based on the all his/her admission records in May 2006 to May 2008. But for another study on, for example, the quality of life of open heart bypass surgery, the study cohort will include this patient’s admission in Dec 2018 and his/her co-morbidity and frailty score will be determined based on the his/her admission records in Dec 2016 to Dec 2018.

A data flow diagram with illustration of the logic of data extraction is provided in the supporting documentation.

All data sets (1) to (7) will be extracted annually. NHS Digital will supply the University of Leicester with pseudonymised HES data and linked Civil Registration- Deaths data. No identifiable information will be included in the data sets.

The University of Leicester will analyse the data for the purposes of producing clinical trial proposals and research papers. For each of the priority research questions in Heart Surgery, the general steps of data analysis are outlined as follows.
a. Data preparation and phenotyping – to define patient groups based on demographic information and diagnosis codes; define specific surgical interventions using OPCS-4 codes; and prepare HES data sets that are longitudinally linked. In-hospital outcomes will be tracked using HES APC and CC data, and mid to long term outcomes will be identified using HES APC, OP, AE, ECDS, DIDs and Civil Registrations - Deaths data bases.
b. In-silico trials
– For a given research question, define the study hypothesis, patient populations, intervention, and primary and secondary outcomes,
– Propose an overall trial design and carry out statistical analysis to obtain the parameters required for designing clinical trials including outcomes rates and treatment effects
– Conduct subgroup analysis and model treatment heterogeneity across patient groups
– Estimate sample size required and assess trial feasibility (in terms of availability of patient population and resources), and
– Carry out sensitivity analyses varying the trial designs, definition of trial outcomes and reassess the sample size requirement and trial feasibility.
c. Output - output trial parameters and produce trial proposals.

The University of Leicester will comply with the Data Sharing Framework Contract requirements.

DATA STORAGE
The data will be exclusively stored and processed at the University of Leicester and not shared with any third parties. The University of Leicester has no access to the files that can link the pseudo identifiers back to the patients. The research team will not carry out any analysis attempting to re-identify patients. The requested data will not be linked with any external data sets. All outputs shared with the project collaborators will be aggregated with small numbers suppressed in line with the HES Analysis Guide.

All data will be stored on the secure dedicated research data storage service known as the Research File Store (RFS) at the University of Leicester. The server is based in University’s main campus, and is not cloud based. The RFS is a secure and resilient server that adheres to current information governance standards and is centrally managed by the University of Leicester to ensure it is updated to meet future changes in data security standards. Security of the system is be governed by the corporate security policy of The University of Leicester.

The RFS is built on an enterprise-class storage facility which is replicated between two secure, access-controlled data centres for recovery purposes. Nightly backups are also taken to an enterprise-class storage facility in the Secondary data centre. Backups are retained for 28 days. Both data centre facilities are owned by University of Leicester and managed by the University of Leicester internal IT Services.

DATA ACCESS
The Leicester Cardiac Surgery Research Group, University of Leicester will control the access of the requested HES and Civil Registration - Deaths data. Only designated researchers employed by the University of Leicester will be granted the access right to process and analyse the data supplied by NHS Digital.

Project collaborators will have no access to the raw patient data, and only aggregated outputs with small numbers suppressed in accordance with the HES Analysis guide will be shared with them.

All data processing and analyses will be carried out within the University of Leicester.

DATA PROCESSING
All individuals processing the data are substantive employees of the University of Leicester. The student referenced in this research team is doing a PhD on a part-time basis and is also a substantive member of staff of the University of Leicester.

Data Processing will take place physically at University of Leicester’s Cardiovascular Biomedical Research Unit located in Glenfield Hospital, Groby Road, Leicester, LE3 9QP via secure remote access to the RFS.

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Modelling the transition from neonatal to paediatric care: a data linkage study — DARS-NIC-400790-V0Y8W

Type of data: information not disclosed for TRE projects

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

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

Purposes: No (Academic)

Sensitive: Non-Sensitive

When:DSA runs 2021-09-16 — 2024-09-15 2022.08 — 2022.08.

Access method: One-Off

Data-controller type: UNIVERSITY OF LEICESTER

Sublicensing allowed: No

Datasets:

1. Civil Registration - Deaths
2. Emergency Care Data Set (ECDS)
3. Hospital Episode Statistics Accident and Emergency
4. Hospital Episode Statistics Admitted Patient Care
5. Civil Registrations of Death
6. Hospital Episode Statistics Accident and Emergency (HES A and E)
7. Hospital Episode Statistics Admitted Patient Care (HES APC)

Objectives:

Following birth, around one in seven babies are admitted for specialist neonatal care in the UK. Admission rates to neonatal care have increased in the last few years, partly due to improved survival of the most vulnerable babies, particularly those born very prematurely or those with serious health problems. More and more of these babies now survive, but the impact of their health and the care received immediately after birth can be lifelong. There has also been an increase in admissions to paediatric intensive care units (PICU) in the last ten to fifteen years. Many admissions may relate to children who received neonatal care immediately after birth, although the exact number is not known.

Very little is known about what happens between neonatal and paediatric care including which children are likely to experience both types of care, and how clinical services, parents and professionals manage the transition. This research will link together neonatal and paediatric care records for the first time to allow investigation of the first two years of the lives of these children.

This project is part of a larger study funded by the National Institute for Health Research Advanced Fellowship programme. The University of Leicester relies on the GDPR Article 6(1)(e) for the legal basis for processing data (processing is necessary for the performance of a task in the public interest or in the exercise of official authority vested in the controller). Additionally, as health data is a special category of Personal Data, the Data Controller relies on 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 University of Leicester require linked pseudonymised record-level data for use in the data linkage workstream of this project (IRAS ID: 283808). The University of Leicester will not release any data to any third party organisations. Any results from this study will be published in aggregate form, with small numbers suppressed as per the HES analysis guidance.

Pseudonymised data related to England (Hospital Episode Statistics (HES) Admitted Patient Care (APC) and Accident and Emergency (A&E) / Emergency Care Data Set (ECDS)), and England and Wales (Civil Registrations (Deaths) data is requested. This will allow for a rich population-based cohort, which is not possible to achieve via any other data sources.

The study team require access to the Civil Registrations (Deaths) data to investigate deaths which occur outside of neonatal or paediatric intensive care (e.g. deaths at home or in hospices). The study team require access to HES ACP/ A&E/ECDS to investigate and understand the healthcare resources used by these children. Without access to this data the study team will only know about intensive care, when the other types of care (e.g. ward and Accident and Emergency) are likely to be more commonly accessed.

This project forms part of a larger study which has three workstreams:
(1) data linkage of neonatal and paediatric data to investigate outcomes in the first two years of life;
(2) exploration of neonatal discharge practices and
(3) understanding the experiences of parents who have had a critically ill child.

This data request forms the entirety of workstream (1) and the results will inform aspects of workstream (2). Workstream (1) will investigate the needs of clinical subgroups of babies (e.g. preterm babies, babies with heart problems) and will include a PhD project looking at the outcomes of pre-term born children. The PhD student will focus their section of the research on neonatal care, intensive care (data from PICANet) and deaths data. The PhD student will not be accessing Hospital Episode Statistics (HES) Admitted Patient Care (APC) and Accident and Emergency (A&E) data sets.

Ethics and Confidentiality Advisory Group (CAG) approvals (section 251) are in place for this study.

The Data Controller for this agreement is the University of Leicester as they determine the purpose and means of processing the data. The University of Leicester will also be the sole processor of NHS Digital data. The NNRD (based at Imperial College, London) and PICANet (based at the University of Leeds, and is run in collaboration with the University of Leicester) will provide data for this project. The project is funded by the National Institute for Health Research, but they have no involvement in the design, planning or running of this study, and as such they are not considered Data Controller.

This study is supported by a Study Expert Advisory Group and a Parent Advisory Group. The Study Expert Advisory Group contains a paediatric and neonatal doctor, an epidemiologist, a social statistician, a nurse and a parent representative The Parent Advisory Group contains parents who have all had experience of children in Paediatric Intensive Care Units (PICU) and Neo-natal care and the group is supported by a representative from the charity, Bliss, who is the leading UK charity supporting families with a baby born premature or sick. Both groups provide regular input into the study for Patient and Public Involvement (PPI). The project has been designed with parents and families at the heart of it, and developed with parents who had children who experienced neonatal care, and all suggestions and ideas were discussed with a diverse group. The Parent Advisory Group was established for the purposes of this study and the initial idea for this project was conceived during a PPI meeting of a previous research study. The parents and families will continue to be involved throughout, including the co-production of
materials for parents and healthcare professionals at the end of this project

Expected Benefits:

This study hopes to address an important research question about the outcomes of children following admission to neonatal care after birth. At the moment, no one knows how many of these children require paediatric care in the early years of their lives. This study aims to publish its first results with 18 months of the receipt of data and have published all findings within three years. The study hopes to lead to recommendations and improvements in care in the following ways:

1. Preparation for families being discharged from neonatal care
Currently, parents are provided with limited or no guidance about the likelihood of their child requiring a future admission to paediatric care. For some children, it is likely they will have ongoing healthcare needs throughout their early lives and this study will help the study team identify what child characteristics are associated with admission to paediatric care or paediatric intensive care. This information can be used, as appropriate, to counsel parents at the point of discharge from the neonatal unit.

2. Policy around neonatal discharge
There is no national guidance about when babies may be ready to be discharged from neonatal care. This study hopes to provide insight into what clinical choices (e.g. discharging a baby home on oxygen) may be associated with an increase in the risk of admission to paediatric care. This hopes to provide information to begin the development of policies surrounding discharge from neonatal care.

This work will involve several peer reviewed publications. The study team hopes to also present their work to local and national clinical commissioning groups and organisations (e.g. British Association of Perinatal Medicine, Paediatric Critical Care Society) and at relevant national/international conferences. The study team will work with parent charities and other organisations to provide appropriate outputs for policy makers including NHS England to which the study team will disseminate through links they have within the relevant organisations.

3. Organising healthcare services around the needs of children who require neonatal and paediatric intensive care
In recent years the number of children surviving neonatal care has increased and the number of children living with chronic health conditions is also increasing. Currently, the study team do not understand the demands and workload requirements this will place on the National Health Service. This study aims to allow the study team to investigate current demands and investigate if trends are changing over time to enable the healthcare service to prepare better for the future.

4. Increasing the public conversation around neonatal and paediatric care
There is a lack of awareness about the impact of neonatal care, but in reality nearly 1 in 7 babies experience an admission. Therefore, this research hopes to increase public awareness about the care provided to this cohort of babies and children.

Outputs:

The results of this study are hoped to be disseminated widely. The research team has strong links with professional organisations in this area including: the British Association of Perinatal Medicine; the Royal College of Paediatrics and Child Health and the Neonatal Nurses Association.

PUBLICATIONS AND REPORTS
The study team aims to make versions of the study protocol and analysis plans available for anyone to access on the study website. (https://www2.le.ac.uk/departments/health-sciences/research/timms/staff-pages/ses26 or another website to be developed). Two peer-reviewed publications from this workstream of the research project (publish between 2021 and 2024) are planned. These publications aim to be provided via open access and lay summaries are planned to be provided of all research. Annual reports are planned to be provided to the National Institute for Health Research as part of the University of Leicester's ongoing research project.

CONFERENCES
Healthcare professionals are involved in supporting this research project, and the findings of this research project are planned to be disseminated through their connections. Key findings from this work aim to be presented at national and international conferences (e.g. World Congress of Pediatric Intensive Care) and meetings (e.g. the annual meeting of the Paediatric Intensive Care Audit Network). No individual level data will be presented or included in summaries of findings (e.g. results from statistical models), only aggregated and suppressed outputs as per the HES Analysis guide. Dissemination at conferences are planned throughout the research project (2021-2024). At the end of this project an online meeting open to researchers and healthcare professionals plan to be hosted as well as potentially podcasts and pre-recorded videos to disseminate key findings of the research.

PUBLIC
The results of this research aims to be promoted to parents, families and the public via the website, social media and via charities. Lay summaries or alternative methods (e.g. podcasts) are planned to be provided, written in collaboration with parents and families involved in this project. These aim to be disseminated via social media and other appropriate platforms throughout the project.

PHD THESIS
Elements of this work will form part of a PhD thesis which will be publicly available upon completion. The PhD student will be a substantively employed full-time member of staff at the University of Leicester.

The data provided in all outputs will be aggregated with small number suppression as per the HES Analysis Guide.

Processing:

NHS Digital is requested to link together two data sources: NNRD (National Neonatal Research Database) and PICANet (Paediatric Intensive Care Audit Network) containing identifiable data (NHS Number, Date of Birth and Postcode) along with a unique Study ID. NHS Digital will link the NNRD and PICANet and provide information about common records and also about records only in the NNRD or only in PICANet.

The NNRD will provide NHS Digital with a Unique study ID for each record in their cohort and PICANet will also provide a Unique study ID for each record in their cohort. The unique study IDs they provide will be unique to each child in their separate cohorts, and as neither NNRD nor PICANet know what records they are each sending to NHS Digital, there may be a NNRD AND PICANET Study ID for one child. NHS Digital will link the NNRD and PICANet cohorts and provide information about common records and also about records only in the NNRD or only in PICANet.

Health data from Hospital Episode Statistics (HES) Admitted Patient Care (APC)and Accident and Emergency (A&E) / Emergency Care Data Set (ECDS) and Civil Registrations (Deaths) data will then be linked to the combined NNRD/PICANet cohort. Only data related to the first two years of life of the child is required to understand the potential short term impact of care received in the neonatal period immediately after birth.

The team at the University of Leicester only require access to pseudonymised record level data which will allow for additional data from the NNRD and PICANet to be added in. The NNRD will provide data from 1 January 2013 to 31 December 2018 and PICANet will provide data from 1 January 2013 to 31 December 2020 (this includes 2 years follow up data). This allows for all children in the cohort to have reached two years of age. Hospital Episode Statistics (HES) / Emergency Care Data Set (ECDS) and Civil Registrations (Deaths) data is required from 1 January 2013 to 31 December 2020 for children aged 2 years and below. This will allow observation of two years of follow up for all children in the cohort.

METHODOLOGY
(1) The NNRD (Imperial College London) and PICANet (University of Leeds) will upload a cohort each via the Secure Electronic File Transfer Service (SEFT), made up of approximately 480,000 individual records in total. The cohort will each contain a Unique Study ID, and the personal identifiers: NHS Number, Date of Birth, and Postcode.

(2) NHS Digital will identify common records between the two cohorts to create one main cohort link to NHS Digital HES/ECDS and Mortality data. NHS Digital will also highlight records which are unique to the NNRD or PICANet via an Encrypted HES_ID.

(3) NHS Digital will use the single cohort to extract HES and Mortality data for children in the first two years of life. (i.e. only provide data of children aged 2 years and under from date of birth 1 January 2013 to 31 December 2018).

(4) NHS Digital will then remove identifiable fields from the HES/ECDS and Mortality extracts, leaving the unique study ID.

(5) NHS Digital will return the pseudonymised HES/ECDS and Mortality extracts to the Data Recipient (University of Leicester) via SEFT.

(6) Data flowing to the University of Leicester from the NNRD/PICANet - The NNRD and PICANet will provide requested clinical data for all records provided to NHS Digital with the pseudonymised identifier (Pseudo-ID) which can be used by the team at Leicester to link the NNRD/PICANet data with that provided by NHS Digital via the Study ID only. Approval has been granted by HQIP for the flow of PICANet data. DSAs are in place for data flow between NNRD/PICANet and the University of Leicester.

All statistical data analyses will be undertaken at the University of Leicester. Only substantive employees of the University of Leicester will be allowed to access the data, which includes the PhD student. All staff are required to undertake the University annual data security training plus prescribed annual NHS security training. The complete pseudonymised study dataset will only be available to individuals working on the project who are all substantive employees of the University of Leicester.

No identifiers are received or stored at the University of Leicester. There will be no linkage of NHS Digital data to other data sets other than those state in this agreement.

Statistical data analysis will be carried out on University of Leicester managed machines connected to the secure university server either directly in person or remotely via a Virtual Private Network (VPN), using an appropriate statistical package. Only substantive employees of the University of Leicester can access this secure server. Areas of the secure server dedicated to research projects are restricted to members of the research team. To remotely access the secure server, a University of Leicester managed machine is required alongside 2-step factor authenticator and connection via the VPN. Users are then able to securely access the secure server on the University’s IT framework. All data analysis will be conducted within the confines of the University’s secure server, and will not be downloaded to remote devices for storage or processing.

HES and ECDS 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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Critically ill children and young people: do national Differences in access to Emergency Paediatric Intensive Care and care during Transport affect clinical outcomes and patient experience? The DEPICT study — DARS-NIC-120105-F0K2L

Type of data: information not disclosed for TRE projects

Opt outs honoured: No - data flow is not identifiable, Anonymised - ICO Code Compliant, No (Section 251, Does not include the flow of confidential data)

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)

Purposes: No (Academic)

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

When:DSA runs 2019-08-24 — 2022-08-23 2019.01 — 2019.11.

Access method: One-Off

Data-controller type: GREAT ORMOND STREET HOSPITAL FOR CHILDREN NHS FOUNDATION TRUST, UNIVERSITY OF LEICESTER

Sublicensing allowed: No

Datasets:

1. Hospital Episode Statistics Admitted Patient Care
2. Hospital Episode Statistics Accident and Emergency
3. HES:Civil Registration (Deaths) bridge
4. Civil Registration - Deaths
5. Civil Registration (Deaths) - Secondary Care Cut
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)

Objectives:

Critically ill children who are admitted to district general hospitals can require specialist transport to a paediatric intensive care unit (PICU). There is considerable variation in the care provided to critically ill children prior to admission to paediatric intensive care. It is unclear whether the differences in timeliness of access to paediatric intensive care, and care delivered during stabilisation and transport by specialist transport teams, matter in terms of clinical outcomes and patient experience. This lack of scientific evidence has led over the years to the evolution of different models of paediatric transport provision, the development of national standards based on expert opinion rather than scientific evidence and has contributed to the lack of progress in improving care at the crucial interface between secondary and tertiary paediatric care. The objective of the DEPICT (Differences in access to Emergency Paediatric Intensive Care and care during Transport) study is to study the association between timeliness of access to paediatric intensive care and 30-day mortality.

The University of Leicester requires pseudonymised linked data for use in the quantitative analysis work stream of the DEPICT Study (IRAS ID: 218569).

The DEPICT Study was instigated and is led by the Chief Investigator based at Great Ormond Street Hospital. Great Ormond Street Hospital hold the contract with the Department of Health for the NIHR funding for the DEPICT study. The study has four workstreams (quantitative analysis, qualitative and questionnaires study, health economic evaluation and mathematical modelling). Great Ormond Street Hospital have a collaboration agreement in place with all the various work stream lead centres including the University of Leicester (who lead Work Stream A -data linkage study), under the lead professor's leadership.

This agreement relates only to the quantitative analysis workstream, which is led by the lead professor based at the University of Leicester. For this agreement Great Ormond Street and the University of Leicester are joint data controllers. Great Ormond Street Hospital in their role as lead for their study, and the University of Leicester in their role as lead for Workstream A.

As Sponsor of the study, Great Ormond Street Hospital, through the Chief Investigator, have a responsibility for the conduct of the entire DEPICT study including Work stream A. The University of Leicester are essentially carrying out the data analysis of the linked data set, therefore will decide how the data is analysed. They will receive the study data and store it. Great Ormond Street Hospital will not receive or have access any data that has been received from NHS Digital.

To undertake the analysis specified in the quantitative workstream, the University of Leicester will have access to pseudonymised linked data. The sources of data are:

1) Paediatric Intensive Care Audit Network (PICANet) audit data from the University of Leeds. This audit is commissioned by the Healthcare Quality Improvement Partnership (HQIP) and University of Leeds is a data processor for the audit data. There has and will not be any involvement from University of Leeds or HQIP in the design or performance of the DEPICT study, in the study itself or this agreement.
2) Case Mix Programme (CMP) audit data from Intensive Care National Audit and Research Centre (ICNARC). There has and will not be any involvement from ICNARC in the design of the DEPICT study, in the study itself or this agreement.
3) Hospital Episode Statistics from NHS Digital.
4) Office of National Statistics mortality data from NHS Digital.
5) Patient Episode Database for Wales (PEDW) data from NHS Wales Informatics Service (NWIS).

For both the audit datasets (PICANet and CMP), the University of Leicester approached HQIP and ICNARC to access and process their audit data for the purpose of Workstream A of this study, and this access has been agreed. Neither HQIP, ICNARC nor the University of Leeds have had or will have any further involvement in this study and, therefore, play no role in the design or performance of the project, and do not have access to any of the data to be disseminated by NHS Digital under this agreement. They will, however, receive study IDs only from the University of Leicester.

The legal basis for dissemination: is:
- Mortality data: Statistics & Registration Service Act S42(4A)(A)
- Dissemination of data: Health and Social Care Act - 261(1) 261 (2)(b)(ii).

The University of Leicester want NHS Digital to identify common records in the two audit datasets (PICANet and CMP) and link PICANet identifiers to HES and mortality datasets. Where common CMP records have been identified, the CMP unique identifier will be added to that record also. The University of Leicester will be the only organisation to access the record level data supplied from NHS Digital, as this is where the statistical team for the DEPICT Workstream A study are based. No other organisations will have access to the data received from NHS Digital.

The University of Leicester is part of the DEPICT study collaboration and is leading the quantitative data analysis workstream. The DEPICT study is funded by the NIHR HS&DR programme (ref: 15/136/45).

The DEPICT Study has three main aims:
1) Understand whether and how a) clinical outcomes and b) experience of critically ill children (and families) transported to PICU are affected by national variations in timeliness of access to care and care provided by transport teams before PICU admission.
2) Study the relative cost effectiveness of the current transport team and evaluate alternative methods of service delivery.
3) Provide evidence for the development of future clinical standards.

The objective of the DEPICT study (see Aim 1a) is to investigate how the clinical outcomes of critically ill children who are transported to paediatric intensive care are affected by national variations in timeliness of access to intensive care. The primary outcome of interest is 30-day mortality and the secondary outcomes are: mortality in intensive care, at 90 days and within a year of admission; length of stay; resource use; number of hospital admissions and days in hospital in the 12 months following admission. In order to achieve these outcomes, the University of Leicester require linkage of PICANet audit data to HES and mortality data and the common records between PICANet and CMP to be flagged; this is so the outcomes of paediatric patients seen in both a PICU and other specialist intensive care units as part of their care can be analysed and a fuller picture of the cohort obtained.

Under this agreement, the only organisation permitted to access and process the data provided by NHS Digital is University of Leicester.

Yielded Benefits:

To date there has been no yielded benefits from this study. University of Leicester are currently undertaking the statistical analysis as outlined in the original application and they anticipate completing the initial statistical analysis in Autumn 2019.

Expected Benefits:

The DEPICT Study addresses an important clinical problem related to the care of acutely ill children in the NHS. The study will provide important information about the differences which may exist between the different paediatric transport services and the outcomes experienced by children. This is particularly important since current national standards from the Paediatric Intensive Care Society (PICS) are expert consensus derived rather than being evidence based.

The main areas of uncertainty addressed by the DEPICT study are:

1. Provision of early, high-quality acute care has been shown to improve clinical outcomes in specific diseases such as paediatric sepsis and head trauma but it is unclear how these findings apply to the vast majority of critically ill children who require stabilisation and transport to a PICU. We will examine whether and how timeliness of access to paediatric intensive care and care delivered during acute stabilisation and transport affect clinical outcomes of
critically ill or injured children with a range of diagnoses and pre-existing medical conditions, so that findings can be generalised to all critically ill children.

2. Centralisation of specialist acute care has occurred in several NHS services such as stroke, trauma, and specialist paediatrics. The findings from our research can provide evidence that can be generalised to evaluate other such centralisations. This is especially relevant to questions related to the trade-off between timeliness of access to acute care and provision of high quality cost effective specialist care.

3. Evidence is urgently required to understand whether and how delays in access to paediatric intensive care and variations in the quality of care provided during acute stabilisation and transport affect clinical outcomes. This study will provide definitive outcome information about critically ill children who receive specialist transport to paediatric intensive care. Development of the transport services and their related PICS standards of care have been driven by expert opinion but these have lacked scientific evidence. It will allow different transport services to compare their service with other services in the country, whilst accounting for the differences in populations and sickness of the children they transport, and will identify inequalities in access and timing of care.


The DEPICT study will generate the high-quality evidence necessary to guide the development of future standards of care for the transport of critically ill children and inform decisions about the associated national policy. This work will be completed by the conclusion of the study in 2022.

Outputs:

The results of the study will be disseminated actively and extensively. The research team has strong links with (a) the PICU community via the Paediatric Intensive Care Society (PICS), PICS Study Group (PICS-SG), and the NIHR CRN: Children Clinical Studies Group (CSG) in Anaesthesia, Intensive Care and Cardiology; (b) the PICU Transport community through the PICS Acute Transport Group; (c) the Healthcare Quality Improvement Partnership national audit programme through the Paediatric Intensive Care Audit Network (PICANet) and Intensive Care National Audit and Research Centre (ICNARC) Case Mix Programme; and (d) NHS England.

The DEPICT Study team plan to write six peer-reviewed publications related to the study aims. A recent paper describing the background to the DEPICT study was published in Paediatric Critical Care Medicine (Feb 2018). An peer-reviewed publication describing the DEPICT study’s initial findings will be submitted within 12 to 18 months of beginning the work. The intention is to publish the findings in high-impact journals and these will be made open-access. A final report overviewing the entire project will be published in the National Institute for Health Research (NIHR) Health Services and Delivery Research journal (funders of this research) by the end of the study (May 2020).

CLINICIANS AND ACADEMICS: Clinicians in the study steering group will be drawn from all transport services in the UK, and will ensure wide dissemination of the results to frontline clinicians. The findings from the work will be presented at national and international conferences, potentially including the Annual Conference of the Royal College of Paediatrics and Child Health, the World Congress of Paediatric Intensive Care, the PICANet Annual Meeting, the Society of Critical Care Medicine Annual Congress, PICS Annual Scientific Meeting, American Association of Paediatrics Conference, the European Society of Paediatric and Neonatal Intensive Care, and British Association of Critical Care Nurses (BACCN). Dissemination at conferences will occur throughout the course of the DEPICT study (2019-2022).

POLICY MAKERS: Recommendations for clinical guidelines arising out of the research will be published and disseminated to professional societies concerned with the care of children presenting with acute illness, including PICS and the Royal College of Paediatrics and Child Health. Our strong links with service managers and NHS commissioners will allow our findings to be disseminated to national policy makers, especially through the PIC Clinical Reference Group. Presentation slides will be prepared for use by the study team or others in disseminating the research findings. The timescale for this will also be throughout the course of the DEPICT study (2019-2022).

PUBLIC: The results of the study will be disseminated to patients and their families, facilitated by the co-applicants, members of the research team who have links with PICS and the NIHR CSG, and via The PICANet Families Group who we have liaised with already. Findings will be made available via the DEPICT Study website (https://depict-study.org.uk/) which will make all results publicly available. These will also be promoted via social media (Twitter @DEPICT_Study). We will ensure that lay summaries are provided (reviewed in collaboration with parents involved in this research). Where appropriate, results will be promoted as press releases. (2019-2022).

Outputs will contain only aggregate level data with small numbers suppressed in line with HES analysis guide

Processing:

The data flows are as follows:

1) Data flows to NHS Digital
University of Leeds (PICANet) and ICNARC (CMP) will each securely transfer a file to the NHS Digital Data Access Request Service (DARS). These files will contain person-identifiable information (NHS Number, sex, post code, date of birth) and unique study identifiers (PICANet: DEPICT Study Number; CMP: CMP identifier) required to perform the data linkage.

2) NHS Digital will identify common records between PICANet data and CMP data

3) Data flows from NHS Digital
- NHS Digital will supply a list of the study identifiers common to PICANet and CMP to University of Leicester
- NHS Digital will provide HES data for all individuals in the PICANet cohort to the University of Leicester. The unique study identifiers (DEPICT study number and CMP identifier, where applicable) will be appended to the end of every episode record provided to the University of Leicester.
- Mortality data for all individuals in the PICANet cohort will be provided to the University of Leicester. The unique study identifiers (DEPICT study number and CMP identifier, where applicable) will be appended to the end of every episode record provided to the University of Leicester.

4) Data flow from University of Leicester
University of Leicester will securely transfer DEPICT study numbers and the unique CMP study identifiers for the records that were identified as been in common by NHS Digital to University of Leeds and ICNARC respectively. No HES or mortality data or any other personal identifiable data will be transferred. This information is shared so that clinical data for the records in common can be securely transferred from both PICANet and ICNARC to the University of Leicester for inclusion in their analysis.

5) Data flow from University of Leeds (PICANet) and ICNARC (CMP)
University of Leeds (PICANet) and ICNARC will provide clinical data from their respective audits for the specific DEPICT and CMP records in common identified by NHS Digital to the University of Leicester by means of secure transfer. No personal identifiers will be transferred.

All statistical analyses will be undertaken at the University of Leicester. The complete study dataset will only be accessed by two individuals employed by the University of Leicester for the statistical analyses. 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).

The datasets required by the DEPICT Study team from NHS Digital are mortality and HES data. Data will be required from 2012/13 to 2017/18 to allow investigation of mortality and details about re-admission to A&E or hospital up to one year after the initial admission to paediatric intensive care. Data is only required on individuals aged <19 years to follow up children who required paediatric intensive care. There will be no requirement nor attempt to re-identify individuals from the data. National data is required to allow comparison of the different specialist transport services across the country.

The results of all analyses will be published in aggregate form, with small numbers suppressed in line with HES guidance. No identifiable data will be held by the University of Leicester; therefore, no identifiable data will be released. Linked study data provided by NHS Digital will be used by the Workstream A team at the University of Leicester to achieve the primary and secondary study aims, i.e. investigate if differences exist in PICU mortality, or at 30 days, 90 days or one-year post-admission or if differences exist in re-admission to hospital and subsequent care in hospital following discharge.

The DEPICT Study has the relevant Research Ethics and Section 251 approvals. Under this agreement, the only organisation permitted to access and process the data provided by NHS Digital is University of Leicester’.

There will be no data linkage undertaken with NHS Digital data provided under this agreement other than that which is specified.

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NAAASP Data Linkage — DARS-NIC-370641-K0J0T

Type of data: information not disclosed for TRE projects

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

Legal basis: Section 251 approval is in place for the flow of identifiable data, Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 – s261(2)(b)(ii)

Purposes: No (Academic)

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

When:DSA runs 2019-05-01 — 2020-08-28 2017.03 — 2017.05.

Access method: One-Off

Data-controller type: PUBLIC HEALTH ENGLAND (PHE), UNIVERSITY OF LEICESTER

Sublicensing allowed: No

Datasets:

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

Objectives:

Community screening for Abdominal Aortic Aneurysm (AAA) by ultrasound has been proven to reduce AAA related deaths and has recently been adopted by the NHS with national coverage established in 2013 and from this year onwards, over 300,000 men will be screened for AAA every year with approximately 4000 AAA detected.
Community screening for AAA in England is carried out by the NHS AAA Screening Programme (NAAASP), part of Public Health England (PHE). NAAASP invites all men for AAA screening in the year of their 65th birthday. Screening is carried out by ultrasound and is both clinically effective and cost effective. NAAASP records the infra-renal aortic diameter for all men who attend for screening. Men found to have an AAA (aortic diameter >30mm) are either entered into a surveillance programme that is also run by NAAASP (AAA 30mm to 54mm) or referred to a vascular surgeon for consideration of surgical repair (AAA >54mm). In order to ensure cost-efficiency.
The incidence of AAA is falling in western populations and this raises the question of whether AAA screening will remain effective in the long-term. In addition, the NHS AAA Screening Programme (NAAASP), who has become part of Public Health England (PHE), will detect a large number of patients with small AAA that will require regular surveillance imaging. The University of Leicester propose to determine the outcomes of men being invited for screening by the NAAASP and investigate clinical factors associated with outcomes by linking a single-year cohort of men invited for AAA screening by NAAASP with multiple years of Hospital Episode Statistics (HES) data via the Health and Social Care Information Centre (HSCIC).
In this project NAAASP will control all personal data and process this into a dataset that contains both pseudonymised and study identifiers. The University of Leicester will receive a dataset from NAAASP detailing the outcomes of screening. NAAASP will send HSCIC dataset comprising a list of NHS numbers and the study identifiers. HSCIC will use this dataset to identify the HES/HES-ONS records for the men in the dataset and provide this data to the University of Leicester with only the study identifiers. The University of Leicester will link the NAAASP data and the HES/HES-ONS data and perform analysis.
The outcomes of patients attending the NAAASP are partially unknown. Patients with AAA are followed up by NAAASP through AAA surveillance and the outcomes of patients referred for surgery are recorded. The cause of death in patients with AAA who die whilst under surveillance is not automatically made available to NAAASP. In addition, those screened and found not to have AAA are discharged from NAAASP follow-up and some patients do not attend for screening.
There is some evidence that patients with a normal aortic diameter at age 65 may develop an AAA later in life and therefore be at risk of AAA related death. Also, NAAASP utilises a technique for the assessment of aortic diameter that results in a smaller measurement when compared to other methods and discharges patients if their aorta is below a 3.0cm threshold. This technique may therefore result in some patients being discharged by NAAASP who may be entered into surveillance in other screening programmes. It is not known whether this puts discharged patients at risk of aortic rupture.
The University of Leicester propose to link all patients invited for screening by NAAASP in 2013/2014 with the HSCIC to obtain HES data as outcomes, with yearly updates.

Yielded Benefits:

HES Critical Care, Admitted Patient Care, Accident and Emergency and Outpatient data linked to Civil Registration data was supplied to the University of Leicester by the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to as NHS Abdominal Aortic Aneurysm Screening Programme (NAAASP) . This Data Sharing Agreement permits the retention of the data for an interim period but no other processing of the data is permitted. Should the University of Leicester wish to process data or request further data in the future they will submit an application. This application must meet all the approved Standards. The following information provides background information on the purpose of the original study. No new data will be released under this version of the agreement, and this agreement allows the applicant to hold and not otherwise process any further data that has already been disseminated. The main output for the short-term aims of this research is a paper that is currently in preparation will be submitted for publication in January 2020. In this paper University of Leicester have demonstrated a strong association of screening attendance and aortic diameter with future cardiovascular risk. Using additional data from other cohorts University of Leicester have shown that this association is independent of cardiovascular risk scoring systems. The main impacts of this paper will be to highlight the potential use of screening data that is currently not clinically used (aortic diameter) and the high cardiovascular risk of men with AAA. The latter impact strengthens evidence for a cardiovascular risk reduction programme to be built into the existing AAA surveillance programme. This extension will run until 28/08/2020 during which time the applicant will publish finalised research papers and retain data for the purposes of responding to any requests by journals to revise analyses. Other yielded benefits of this dataset relate to the planning of future research. i) This work in cardiovascular risk has provided background evidence for a grant application to the NIHR to co-develop a patient-centred cardiovascular risk reduction programme for the NHS AAA Screening Programme. This was submitted in November 2018 and was funded by the NIHR in August 2019. ii) The NHS AAA Screening Programme also has an interest in a trial of triple cardiovascular screening (AAA + hypertension + peripheral arterial disease) since this has been shown to reduce all-cause mortality in a trial in Denmark. The logical and cost-efficient research design for this is a cluster randomized trail but to design this it is essential to be able to estimate variations in mortality by region. The linked NAAASP-HES-Mortality that this DSA has enabled allows this information to be easily calculated. Without this DSA, planning this future trial would be very difficult. Data received under this DSA has directly supported feasibility work for an NIHR Programme Grant to undertake this clinical trial. This Programme has now been conditionally funded. Healthcare benefits: In work to date using this dataset - University of Leicester have demonstrated that there is a strong association between the outcomes of AAA screening and future cardiovascular risk. University of Leicester have shown that men who do not attend for AAA screening, and men who are screened but found to have abnormal aortic diameters are at particular high risk of adverse cardiovascular events. Of particular novelty, the University of Leicester have shown than small aortic diameters are associated with high cardiovascular risk as well as large aortic diameters. To disseminate these benefits University of Leicester are in the process of writing a scientific paper that will be submitted for publication in January 2020. As well as using the data derived from this data sharing agreement University of Leicester have used additional data from other cohorts and shown that these associations are independent of cardiovascular risk scoring systems. The main impacts of this paper will be to highlight the potential use of screening data that is currently not clinically used (aortic diameter) and the high cardiovascular risk of men with AAA. The latter impact strengthens evidence for a cardiovascular risk reduction programme to be built into the existing AAA surveillance programme. The data has been presented at national conferences as part of the University of Leicester's dissemination strategy and this has resulted in the following published abstracts: 1. Cardiovascular risk in patients with small abdominal aortic aneurysms. A Saratzis, D Sidloff, M Bown. Lancet 2017;389(S1):89. Spring Meeting on Clinician Scientists in Training, London 2017. 2. A national analysis of short-term AAA screening outcomes: a reduction in operative mortality but not in rupture related mortality. D Sidloff. British Journal of Surgery 2017;104(S5):9. Vascular-Societies Annual Scientific Meeting, Manchester 2016. 3. Social Deprivation, screening attendance and mortality. D Sidloff. British Journal of Surgery 2017;104(S5):6. Vascular-Societies Annual Scientific Meeting, Manchester 2016. Academic benefits: Other important benefits of this research have been to future research. Work in cardiovascular risk has provided background evidence for a grant application to the NIHR to co-develop a patient-centred cardiovascular risk reduction programme for the NHS AAA Screening Programme. This was submitted in November 2018. The NHS AAA Screening Programme has an interest in extending the scope of the AAA screening programme to a multi-component screening programme. Triple cardiovascular screening for AAA, hypertension and peripheral arterial disease has been shown to reduce all-cause mortality in a trial in Denmark. There is an interest in running a trial in the UK to determine if such multi-component screening would be clinically effective in the UK population. The logical and cost-efficient research design for this is a stepped-wedge cluster randomized trial. To design this it is essential to be able to estimate variations in mortality by region screening region. The linked NAAASP-HES-Civil Registration data received has enabled and will continue to allow these data to be easily calculated.

Expected Benefits:

In 2013/14 the NHS completed its first year of national screening for AAA. In the NAAASP men in the year of their 65th birthday are invited to have an ultrasound scan of their abdomen to screen for AAA. Screening men for AAA by ultrasound has proven to be clinically and cost-effective. If an AAA is detected there are well established pathways for treatment of large AAA, which are at risk of bursting (surgery), and clinical monitoring of small AAA, which are at low risk of causing harm. All men with AAA are followed-up by NAAASP.
Only around 1.5% of men screened for AAA are found to have an AAA however. NAAASP screens over 300,000 men every year and measures the diameter of their abdominal aorta. It has been well established that aortic diameter is an indicator for the risk of dying from cardiovascular disease, with the highest risk in those with very small or very large aortic diameters. Whilst NAAASP measures and records aortic diameter in the men it screens for AAA it does not follow these men up. Furthermore, attendance rates for AAA screening are in the region of 80% and nothing is known about the long-term risk of AAA-related morbidity/mortality in the men who do not attend for screening.
In this project the University of Leicester wish to determine whether there are opportunities to improve the health of men attending for AAA screening beyond simply the detection and treatment of AAA. Since NAAASP has already been set up and is measuring aortic diameters in all men attending for screening, if the University of Leicester can identify those men at high risk of cardiovascular events and flag these men for the institution of secondary prevention in primary care, the University of Leicester can add significant value to the process of AAA screening. Secondarily, the University of Leicester wish to identify whether screening non-attenders are at high-risk or low-risk of AAA-related or cardiovascular events to determine whether additional effort in re-inviting these non-attenders would be worthwhile or not.

Outputs:

The University of Leicester will use this data for research purposes and to feedback to NAAASP outcomes for service evaluation. Only de-identified data will be supplied to the University of Leicester. Due to the long-term nature of AAA related outcomes after screening the University of Leicester expect that the research outputs will not occur for at least 5 years and will continue to be produced at such intervals for at least 15 years. The service evaluation aspects of this work will be produced on a yearly basis. The University of Leicester will produce an annual report for the NHS AAA Screening Programme based on the linked cohort. The University of Leicester will produce research publications from the data.
The NAAASP annual report will be sent directly to NAAASP. NAAASP will include summary data in their publically available national programme reports. The University of Leicester’s data table suppression rules are adhered to in the report they send to NAAASP. Research publications will be open-access and available to the public. The University of Leicester will again ensure that the University’s table suppression rules are adhered to in the preparation of these publications. These suppression rules are aligned with the HES analysis guide and where they differ the University’s rules are more robust.

Processing:

1. NAAASP will identify all men invited for screening in the 2013/2014 English screening cohort and all men with small AAA already under NAAASP surveillance. NAAASP holds this personal information for these men for the purposes of their clinical care.
NAAASP will provide screening outcome data for the cohort to the University of Leicester. This data will contain a study ID for each individual. No personal data will be transferred to the University of Leicester.
NAAASP will provide the NHS numbers of these men to the HSCIC, together with a study ID.

2. HSCIC will link the patients identified by NAAASP with HES/HES-ONS data using the NHS numbers and provide this linked data to the research team at the University of Leicester, using the same study ID as those used by NAAASP to transfer data to the University of Leicester.
HSCIC will then supply the University of Leicester with HES/HES-ONS data stripped of identifiers other than the study ID supplied by NAAASP.
The University of Leicester will apply for updated linkage reports on a yearly basis.

3. The University of Leicester will receive data from both NAAASP and HSCIC. This data will be linked using the study ID and analysed.
The University of Leicester will provide NAAASP with annual reports based upon the data, the content of which will be determined by NAAASP but will primarily consist of all-cause and aneurysm-specific mortality and aneurysm-related morbidity.
The University of Leicester will also analyse the data for the purposes of producing research papers focussed on the description of mid- to long-term outcomes of contemporary AAA screening.
No personal data will be held or processed by the University of Leicester.

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Project 10 — DARS-NIC-347200-H9G0Q

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, and Non Sensitive

When:2016.04 — 2016.08.

Access method: Ongoing

Data-controller type:

Sublicensing allowed:

Datasets:

1. MRIS - Cause of Death Report
2. MRIS - Flagging Current Status Report

Objectives:

Researchers from the National Institute for Health Research (NIHR) Diet, Lifestyle and Physical Activity Biomedical Research Unit are investigating the association of objectively measured levels of physical activity and sedentary behaviour with the risk of all-cause and disease-specific mortality. University of Leicester is requesting ONS-mortality data for its ‘Walking Away from Type 2 Diabetes Study’ to be used to answer this question.
The ‘Walking Away from Type 2 Diabetes’ was conducted by the Diabetes Research Centre, University of Leicester. In total 833 participants were recruited to the study from January 2010 to January 2011. Of these, 719 gave consent for their future health status to be accessed. University of Leicester is seeking ONS-mortality linkage for these 719 individuals.
Data will not be shared with a third party and will be stored on secure servers controlled by the University of Leicester

Expected Benefits:

Over recent years sedentary behavior, conceptualised as any non-exercise sitting, has gained increasing interest as a distinct health behaviour that acts as an important determinant of mortality and mortality independently to MVPA. This has initiated research activity and public health attention on the possible benefits of displacing time in sedentary behaviour for time in light-intensity physical activity as an additional target to traditional lifestyle interventions focused on the promotion of MVPA. However, further research is needed with morbidity and mortality outcomes and objective measures of sedentary behaviour to adequately quantify the distinctive association of sedentary behaviour with health. Data generated by this study will help establish the strength of the association between sedentary behaviour and mortality risk and whether this relationship is fully independent of habitual physical activity levels.
The research has been commissioned by the NIHR Leicester-Loughborough Diet, Lifestyle and Physical Activity Biomedical Research Unit and the results will be feed back to NIHR through the process of annual reporting.
This analysis will also inform NICE guidance and guidance from other national/international health care organisations in the future. NICE have already held a Topic Advisory Workshop on sedentary behaviour and are likely to require robust evidence with which to form guidance specific to sedentary behaviour in the near future. Once this research is in progress, University of Leicester will contact the Chairperson of all relevant NICE committees (related to physical activity, sedentary behaviour or diabetes prevention) to make them aware of this project. University of Leicester will also seek to present any finding as expert testimony.
This research will also inform lifestyle interventionists of the importance of targeting sedentary behaviour within the context of lifestyle intervention.”

Outputs:

The results of the analyses highlighted above will be disseminated through presentations at international topic-relevant conferences and publication in peer-reviewed academic medical journals. University of Leicester anticipate that results will be ready for dissemination by December 2016.
Findings will be presented at the meetings organised by the “International Society for Behavioral Nutrition and Physical Activity (annual)” or the “International Congress on Physical Activity and Public Health (every two years)”. Results will be published in a peer-reviewed medical journal. In the first instance University of Leicester will target a high impact journal such the Lancet or Journal of the America Medical Association. The exact journal will be dependant on the peer-review process and journal acceptance.
The level of output data will be statistical in nature, i.e. the risk of all-cause mortality was reduced by XX% per every 30 minute difference in moderate-intensity physical activity. Individual record level data will not be published or shared with a third party.

Processing:

University of Leicester want to test the hypothesis that objectively measured daily sedentary time and time in moderate-to-vigorous physical activity (MVPA) are both independently associated with all-cause and cardiovascular mortality.
The ‘Walking Away from Type 2 Diabetes’ dataset for which linkage to ONS-mortality linkage is being requested includes levels of objectively measured average daily time spent sedentary (i.e. sitting) and in MVPA. Objective measurements were obtained through accelerometer technology.
The ‘Walking Away from Type 2 Diabetes’ study received a favourable NHS ethical review and patients were given the option of consenting to having their future health status accessed. Only those that explicitly provided this consent will be included in the dataset sent for linkage.
Cox proportional hazard models will assess the independent associations of baseline sedentary time and MVPA time with all-cause and cardiovascular mortality that occurred from baseline to follow-up (most current ONS-mortality data). Assumptions of linearity will be assessed. Areas of non-linearity likely at the extremes of sedentary behaviour will be analysed using spline techniques. Data will be adjusted for accelerometer wear time and measured/clinical/anthropometric/demographic confounders.
The hazard ratios obtained from the above analysis will be combined with those generated from other studies from which the outputs are accessible to University of Leicester using standard meta-analytic methods in order to increase the power and generalizability of this project’s findings. However, University of Leicester will not merge or link this data with other datasets or allow access to third parties. All analysis will be conducted within the Diabetes Research Centre, University of Leicester.

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