Good TREs work

Nottingham University Hospitals NHS Trust projects

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

Incidence of peri-prosthetic fracture with the cemented collarless polished taper stem — DARS-NIC-392012-L7T4Q

Type of data: information not disclosed for TRE projects

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

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

Purposes: No (NHS Trust)

Sensitive: Non-Sensitive

When:DSA runs 2024-03-11 — 2027-03-10 2024.05 — 2024.09.

Access method: One-Off

Data-controller type: NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST

Sublicensing allowed: No

Datasets:

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

Objectives:

Nottingham University Hospitals NHS Trust (NUH) requires access to NHS England data for the purpose of the following research project:
“Incidence of peri-prosthetic fracture with the cemented collarless polished taper stem following total hip replacement (THR)”.

The following is a summary of the aims of the research project provided by Nottingham University Hospitals NHS Trust:

“Periprosthetic fractures are a serious complication of total hip replacement (THR). Recent publications have suggested a higher prevalence of periprosthetic fractures with the collarless polished taper stem compared to other polished taper stem designs and a higher revision rate for periprosthetic fractures in the UK National Joint Registry. A small audit performed at Nottingham Teaching Hospitals found that its experience was that the periprosthetic fracture rate in the collarless taper stem was in line with the periprosthetic fracture rate in other polished taper stem designs. The aim of this study is to identify if any of the patients who have had a collarless taper stem total hip replacement in Nottingham University Hospitals have suffered a periprosthetic fracture after surgery. Our large cohort size would be the largest in the published literature for this specific stem, and so the aim of the study is to give an answer to the question of periprosthetic fractures around this specific collarless tapered stem”.

The following NHS England Data will be accessed:
• Hospital Episode Statistics (HES) Admitted Patient Care (APC) – necessary to provide information to identify any periprosthetic fractures in the patient cohort, in order to give a clear periprosthetic fracture rate. It will also allow for the assessment of these fracture patterns to see if there is any correlation.

The level of the data will be identifiable because Nottingham University Hospitals NHS Trust holds the identifying details. However, the data that will be disseminated under this data sharing agreement (DSA) will contain no identifying details.

The Data will be minimised as follows:
• Limited to a study cohort identified by Nottingham University Hospitals NHS Trust, approximately 2900 patients, to include any patient who received a collarless tapered stem as part of their total hip replacement at Nottingham University Hospitals, who then suffered a fracture around their total hip replacement.
• Limited to data between 2009 and latest available at the time of the dissemination (expected in 2024), as fracture can occur anytime following a THR, 2009 is the earliest date that this medical device was first fitted.
• Limited to conditions relevant to the study identified by specific ICD or OPCS codes.

Nottingham University Hospitals NHS Trust is 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 Zimmer Biomet. The funding is specifically for the study described. Funding is in place until completion of the study.

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

Data will be accessed by an individual with a letter of release for Nottingham University Hospitals NHS Trust. The individual’s substantive employer is the University Hospitals of Derby and Burton NHS Foundation Trust and under their contract, it states their commencement date as 16/02/2023 – 31/03/2025 unless terminated earlier in accordance with the contractual controls specified. The individual is permitted to work specifically on the study described above and must report to the Chief Investigator who is a substantive employee of Nottingham University Hospitals NHS Trust, for all supervisory requirements, they must adhere to all organisational policies and controls during this time.

A Public and Patient Involvement and Engagement group was not used to help refine the purpose of the research, as Nottingham University Hospitals NHS Trust felt this was not appropriate for this type of retrospective study of data, however after further advice from the Confidentiality Advice Team (CAT) the applicant confirmed they are working with the patient and public involvement team at NUH and are advertising the opportunity for PPI through posters and through formal discussions about the study through their Research Hub website: https://www.nottinghamresearch.org/ and through the NIHR People in Research website, to further build their evidence of meaningful engagement with patients, service users and the public.

Yielded Benefits:

Expected Benefits:

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

The use of the data could:
• lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.
• advance understanding of the need for, or effectiveness of, preventative health and care measures for particular populations or conditions.
• inform planning health services and programmes, for example, to improve equity of access, experience, and outcomes.
• 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 that need to be addressed.
• support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work).

The findings of this project may have a significant effect on the health of patients. The choice of implant in a total hip replacement is a crucial decision in the treatment algorithm, the finding of this study may play a significant role in the choice of implants for a total hip replacement, both nationally and internationally.

Periprosthetic fracture is a significant injury and has huge consequences. The information gained from this study may help identify the risks of fracture around this particular hip replacement stem, which in turn may help with the care of all patients requiring a hip replacement.

The benefit of this study may include clearly answering the question as to whether this particular implant is associated with periprosthetic fractures. The dissemination of the findings of this study will follow a programme of local and regional presentations, followed by peer-reviewed journal publications and national/international presentations.

The impact of this study may be profound, the collarless tapered stem is the 2nd most-used implant for total hip replacements in the UK, averaging around 7000 per year. Therefore the outcome of this study may affect a huge number of patients and clinicians. The benefits are difficult to quantify, especially as the findings of the study are pending the outcome of the data collection and processing. The aim is to have the information ready for dissemination by the end of 2024.

It is hoped that through publication of findings in appropriate media, the findings of this research will add to the body of evidence that is considered by the bodies, organisations, and individual care practitioners charged with making policy decisions for or within the NHS or treatment decisions in relation to specific patients.

Outputs:

The expected outputs of the processing will be:
• Submissions to peer-reviewed journals
• Presentations at specific conferences.

Following the conclusion of this study the aim is to disseminate the results to the orthopaedic and scientific community. This will be done via numerous channels including presentations (local, national, and international) and peer-reviewed journals. It may have an impact on policy decisions as the decision to continue to use this particular implant may be affected by the results of this study.

The target date for the production of outputs is 2024.

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

The outputs will be communicated to relevant recipients through the following dissemination channels:
• Journals
• Industry newsletters

Processing:

Nottingham University Hospitals NHS Trust will transfer data to NHS England. The data will consist of identifying details specifically NHS Number, Date of Birth, Postcode, and a unique person ID for the cohort to be linked with NHS England data.

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

The Data will not be transferred to any other location.

The Data will be stored on servers at Nottingham University Hospitals NHS Trust.

The Data will be accessed onsite at the premises of Nottingham University Hospitals NHS Trust only.

The Data will not leave England at any time.

Data will be accessed by an individual with a letter of release at Nottingham University Hospitals NHS Trust. The individual will act as an agent of Nottingham University Hospitals NHS Trust at all times under supervision from employees of Nottingham University Hospitals NHS Trust. Aside from this individual, access is restricted to employees or agents of Nottingham University Hospitals NHS Trust. who have authorisation from the Chief Investigator.

Zimmer Biotec is not permitted to access the Data, Zimmer Biomet will not suppress or alter any outcomes of the study.

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

The identifying details will be stored in a separate database to the linked dataset used for analysis. All analyses will use the pseudonymised dataset. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset.

Researchers from the Nottingham University Hospitals NHS Trust will process the Data for the purposes described above.

Access to HES data via the NHS Digital On-Line Portal — DARS-NIC-10620-V9D8R

Type of data: information not disclosed for TRE projects

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

Legal basis: Health and Social Care Act 2012, Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 - s261 - 'Other dissemination of information', 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: Yes (NHS Trust)

Sensitive: Non Sensitive, and Non-Sensitive

When:DSA runs 2019-03-15 — 2020-03-14 2017.06 — 2024.09.

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

Data-controller type: NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST

Sublicensing allowed: No

Datasets:

  1. HES Data Interrogation System
  2. Hospital Episode Statistics Accident and Emergency
  3. Hospital Episode Statistics Admitted Patient Care
  4. Hospital Episode Statistics Critical Care
  5. Hospital Episode Statistics Outpatients
  6. Hospital Episode Statistics Accident and Emergency (HES A and E)
  7. Hospital Episode Statistics Admitted Patient Care (HES APC)
  8. Hospital Episode Statistics Critical Care (HES Critical Care)
  9. Hospital Episode Statistics Outpatients (HES OP)
  10. Emergency Care Data Set (ECDS)

Objectives:

Outline of the East Midlands Academic Health Science Network and the Health Analytics and Informatics team:

The East Midlands Academic Health Science Network (EMAHSN) is hosted by Nottingham University Hospitals NHS Trust. There are 14 Academic Health Science Networks (AHSN) across the country established in 2013 on an initial five year licence and the EMAHSN objective is to improve health in the East Midlands by spreading innovation at scale and pace (see http://emahsn.org.uk/).

The EMAHSN is accountable to NHS England who fund the AHSNs and there is a strong reporting mechanism to ensure both impact and value are delivered. EMAHSN is hosted by Nottingham University Hospitals NHS Trust. The governance structure in place is designed to widen involvement in the Network and further strengthen support to EMAHSN programmes; all of which will ensure that EMAHSN are accountable to members and are able to deliver a successful portfolio of activity.

EMAHSN Governance arrangements:

Steering and delivery groups

Three steering and delivery groups oversee EMAHSN clinical, patient safety and industry and enterprise programme areas: providing expertise and guidance, scrutiny, leadership and advocacy. Membership includes representatives from East Midlands providers, commissioners, industry, the East Midlands Strategic Clinical Networks and Clinical Senate, the East Midlands PPI Senate, subject specialists, partner organisations and third sector.

The remit of the groups includes:

• Subject and topic specific advice and guidance
• Subject and topic specific expertise and scrutiny
• System ownership and leadership
• Driving forward delivery of agreed objectives
• Advocacy for the programme
• Advisory Council

The Advisory Council

The Advisory Council is chaired by an Independent Chair. It is made up of senior leaders from throughout the region, bringing together researchers, clinicians, patients, industry and educators with a wealth of strategic, financial and operational experience and a strong track record in delivery.

The remit of the Council includes:

• Advice and guidance at a regional level
• Consultation with constituent organisations to determine priorities and spot opportunities
• Forward planning and agreeing overall portfolio
• System wide leadership
• Creating dynamic partnerships
• Mobilisation of wider resources

EMAHSN Governance Board

Remit includes scrutiny and assurance of:

• Financial, performance and risk management
• Delivery against EMAHSN strategy and business plan
• Equality impact and action

Board members are required to adopt governance best practice including upholding the ‘Standards for members of NHS boards and CCG governing bodies in England’ published by the professional standards authority.

Governance Board members:

• Independent Chair
• Vice Chair
• Independent Directors
• Managing Director
• Deputy Managing Director/Head of Programme Office
• PPI Senate representative**

The EMAHSN is funded by NHS England and EMAHSN has not followed a membership model (ie organisations do not contribute to the EMAHSN funding) however the AHSN does provide support to any health and social care organisations in the region who can benefit from the innovations EMAHSN are involved in.

The Health Analytics and Informatics team are one of the enabling workstreams which provide support to the clinical and other workstreams by utilising expert analysis to improve patient care by understanding opportunities for improving healthcare.

The team’s expertise can be made available for other health and social care organisations who have a skills or resource gap, for which there can be a charge to enable resources to be provided in the team to increase capacity – examples to date include providing support for local Vanguard projects and hosting an Analyst who is evaluating the Upper Gastro-Intestinal cancer pathway on behalf of the Clinical Network and Cancer Research UK (these projects do not use HES data, but included to outline the work EMAHSN have been involved in). Analysis is undertaken for NHS Trusts on a specific topic where they have not had the capacity or expertise. All staff who have access to HDIS are employees of Nottingham University Hospital (NuH) and therefore have Trust (NHS) contracts which ensure that staff are required to comply with all Trust policies and procedures.

How EMAHSN work

The EMAHSN Health Analytics and Informatics team are an enabling resource for the wider Health Community as well as the EMAHSNs workstreams, so can be involved in a wide range of projects. As part of the project proposal / scoping process there is a formal process to ensure and document that there is a demonstrable patient and/or service benefits, along with how the information will be used e.g. business case, service improvement plan, investigation into patient flows (e.g. service use by dementia patients) before projects are commenced. **In summary projects are approved only where patient benefits are clearly identified and the project confirmed as being appropriate in terms of delivering realistic, usable outcomes and the use of the data is appropriate and proportional. The informatics team are fortunate to have highly experienced, very senior clinical and informatics leadership which ensures only appropriate projects are undertaken and these projects have suitable oversight. The EMAHSN have a governance framework and the Informatics team has governance arrangements that work alongside this, but are independent in the sense of a project that was not an appropriate use of data would not be undertaken. In summary, the co-leads approve requests prior to work starting and will review outputs before they are sent. While the team’s analysts are highly professional and experienced, this provide assurance that senior accountable review is undertaken prior to information being shared. The team has the active support of Nottingham University Hospitals’ Information Governance team who provide advice and clarification where needed.


HDIS is only used after all other information sources have been explored (such as publically available data, data from benchmarking tools such as Healthcare Evaluation Data or data from individual Trusts) and is the best or most efficient way of answering the question and providing the information needed. This can include where it is impractical or excessively resource intensive to obtain eg individual requests to a large number of Acute Trusts which would involve considerable amounts of additional sending and processing of data on their (and our) part.

Providing an understanding of the acute aspect of the patient journey is an essential part of system wide change, and often available data is limited to a very broad group or one organisation. HES has allowed EMAHSN to deepen the understanding of patients accessing acute services, for example patients with multiple conditions and/or multiple admissions. The ability to explore more complex issues such as length of stay or readmissions and compare across the region can identify the effectiveness of local projects to inform adoption and spread, ensuring all patients can benefit from the best practices and services are delivered most effectively.

Small numbers are always suppressed in line with the HES analysis guide, outputs only contain aggregate level data and no data is linked.

Data will only be used for purposes relating to the provision of healthcare or the promotion of health in line with the requirements of the Health and Social Care Act 2012 as amended by the Care Act 2014.

Yielded Benefits:

Here are two specific examples of how EMAHSN have used HDIS HES data previously – the first to understand the potential impact of delirium in the East Midlands and the second to highlight a poorly understood aspect of the care mental health patients receive. Title: Supplementary data pack for Patient Safety Collaborative event to highlight the extent and impact on patients of delirium Output: http://emahsn.org.uk/psc-priority-areas/delirium/ Published On the EMAHSN website, publically available to download without any charge Benefits The data pack and infographic (produced by a specialist design company and using additional data alongside that produced by the Informatics team) outlined the impact on local patients of delirium, for example increased proportion of patients having delirium recorded over time and a significantly increased length of stay and readmissions for these patients. Local data fostered ownership of the issue and outlined the impact to patients and services in the region. The event was intended to raise awareness of the condition, its impact on patients’ healthcare experience and the importance of early recognition and as such was seen as a key driver to change practice. Projects were inspired by the event and by knowing the extent of the needs of local patients, which were only able to obtain from HES data. Title: Mental Health in the East Midlands data pack (A&E attendances data) Output: http://emahsn.org.uk/mental-health/mental-health-innovation-exchange/ Published On the EMAHSN website, publically available to download without any charge Benefits Understanding the A&E attendance for psychiatric disorder formed part of the data pack, innovation event and call for proposals which has resulted in six projects being selected for EMAHSN funding. A&E activity forms only one aspect of the care of this group of patients it was felt to be very useful in understanding the experience that this group of patients have and will be valuable in understanding the potential impact of these projects ie whether they reduce or increase the attendance in A&E for mental health issues.

Expected Benefits:

The outputs from the team are used in a number of ways which benefit patients. Many of EMAHSN reports are for, and disseminated by, region-wide bodies (for example the EMAHSN) ensuring the greatest impact from the work undertaken.

1) Better services for patients. Providing solid, reliable and accurate data to support an understanding of current services and inform future service design. Reports have been used to inform both Commissioning and Provider organisations to support discussions on service need and potential areas for investment/development. This benefits patients by ensuring scarce resources are targeted most effectively and support the decisions on projects which demonstrate the most benefit to patients and the healthcare economy as a whole. It is difficult to quantify the effect of improved analysis in financial terms or on the outcome of decisions, as reports are used to enable informed decision making. This is why there is an insistence on capturing the link between the reports provided and the intended patient/service benefit which will be delivered by use of the information during the project scoping process.

2) Driving effective and efficient healthcare. Identifying areas for service improvement or areas affecting patient safety, ensuring patient activity and flows are understood, for example number of attendances or admissions, length of stay or readmissions for a particular condition or pathway. Where evidence is provided that a proposed initiative does not add value, this offers significant benefit to the healthcare economy by avoiding investment which does not demonstrate valuable improvements in patient care as well as identifying those that do. While these are not definitive measures of quality, understanding these factors for particular patient groups informs investment decisions, for example these are factored into the evaluation of the EMAHSN call for proposals and local service development plans.

3) Safer care. Evaluating the impact of service improvements on hospital activity, identifying risk factors relating to specific conditions (eg CVD outcomes) and providing evidence to support initiatives, for examples targeting higher risk patients.

4) Better management of data. Avoiding the unnecessary processing, movement and management of data – by utilising one existing source, rather than seeking data from multiple organisations for each project, significantly reduces the transmission and processing of data and allows for consistent processing. It also avoids the delay in producing the evidence for service improvement/effectiveness. Standardised, validated data leads to more accurate results enabling comparison between organisations and safe, region-wide aggregation.

Here are two specific examples of how EMAHSN have used HDIS HES data – the first to understand the potential impact of delirium in the East Midlands and the second to highlight a poorly understood aspect of the care mental health patients receive.


Title: Supplementary data pack for Patient Safety Collaborative event to highlight the extent and impact on patients of delirium
Output: http://emahsn.org.uk/psc-priority-areas/delirium/
Published On the EMAHSN website, publically available to download without any charge
Benefits The data pack and infographic (produced by a specialist design company and using additional data alongside that produced by the Informatics team) outlined the impact on local patients of delirium, for example increased proportion of patients having delirium recorded over time and a significantly increased length of stay and readmissions for these patients. Local data fostered ownership of the issue and outlined the impact to patients and services in the region. The event was intended to raise awareness of the condition, its impact on patients’ healthcare experience and the importance of early recognition and as such was seen as an key driver to change practice. The EMAHSN is working with Mid Trent Critical Care Network, to increase awareness of delirium, and is supporting a local nurse specialist to collect data and raise awareness for relatives, patients and professionals (including how to manage these patients) for elective orthopaedic patients over the age 75. These projects are commencing and were inspired by the event and by knowing the extent of the needs of local patients, which were only able to obtain from HES data.

Title: Mental Health in the East Midlands data pack (A&E attendances data)
Output: http://emahsn.org.uk/mental-health/mental-health-innovation-exchange/
Published On the EMAHSN website, publically available to download without any charge
Benefits Understanding the A&E attendance for psychiatric disorder formed part of the data pack, innovation event and call for proposals which has resulted in six projects being selected for EMAHSN funding. A&E activity forms only one aspect of the care of this group of patients it was felt to be very useful in understanding the experience that this group of patients have and will be valuable in understanding the potential impact of these projects ie whether they reduce or increase the attendance in A&E for mental health issues.


Most projects now undertaken by the EMAHSN informatics team have a regular impact statement and are reported to NHS England as part of the EMAHSN standard reporting. The impact measures outline the extent and level of attribution of the impact as well as a clear description of the impact in 10 different categories for each project. This robust reporting mechanism ensures impacts are captured and capitalised upon.

Outputs:

The remit of the team is to support projects that aim to improve services, e.g. providing evidence of the effectiveness of an intervention/care pathway or highlighting a service need, so outputs can vary. Data is always aggregated and follows the HES analysis guide with regards to small number suppression and guidance regarding sensitive conditions.

EMAHSN have provided some examples of previous work undertaken, and further examples below. The information provided is used in a number of ways, and often this can only be obtained via HES:

• To provide a greater understanding of the demand for a service by a particular group or groups of patients to inform service design and investment decisions

• To understand variations in aspects of a group of patients’ care, such as length of stay or readmission, to identify ‘what good looks like’ and where patient care may not be delivering to the desired level

• To enable decisions to be made regarding where innovations may have the greatest impact on patient care, and to monitor that impact eg reduced length of say, readmissions or admission to hospital

One query EMAHSN have at present is to extend initial analysis that explores the utilisation of outpatient clinics for long term conditions to inform the local Sustainability and Transformation Plans – by understanding the extent of this activity we will be able to identify areas where (and then monitor the impact of) potential innovations may provide alternatives to outpatient care, such as technologies that enable and support self-care. This work is to be completed as soon as possible due to the need to align with these plans.

Further examples of projects are included below, all require the analysis of appropriate data sources in order to identify opportunities for improvement or to assess whether changes have delivered the required outcomes. Whilst EMAHSN use publically available data where possible, and sometimes Trusts’ own data when working on a Trust level project, HDIS is an essential data source for a number of projects. The analysis undertaken helps healthcare providers and commissioners to deliver the best possible care based on the best available evidence. HES data is used during the development of programmes to evaluate potential innovations based on actual activity and demand both locally and regionally. Academic Health Science Networks are being encouraged to collaborate to deliver innovations more widely, and it is anticipated the analyses will need to consider activity outside of the region and potentially nationally to support the case for further adoption and spread of innovation.

Examples of previous single Trust level projects include looking at selected urological procedures including the use of robotic techniques after query by the NHS Trust Development Authority (now NHS Improvement), and exploring A&E activity to inform the local 5 year plan.

Projects for the EMAHSN, the output of which are usually in the public domain and always free to access, include data packs to support call for innovation proposals, for example A&E attendances for Mental Health event (http://emahsn.org.uk/mental-health/mental-health-innovation-exchange/); cancer information pack exploring activity and performance of cancer care in the East Midlands; investigation into the effects of a diagnosis of delirium on patient outcomes in the East Midlands for the Patient Safety Collaborate Delirium event (http://emahsn.org.uk/psc-priority-areas/delirium/) and Cardio Vascular disease information pack used by CCGs as a resource to support commissioning (for the East Midlands Clinical Senate).

Some analyses inform decisions regarding whether projects or innovations will deliver the impact or meet the needs of an identified group of patients which may be for internal use and not developed sufficiently to be published externally – for example understanding outpatient activity for long term conditions to feed in to Sustainability and Transformation Plans; however where analysis results in a report that is appropriate to publish, these are made available via the website for free of charge, for example Cancer Intelligence Report (http://emahsn.org.uk/cancer/cancer-innovation-exchange-event/).

Processing:

Approved HDIS trained data analysts’ within the Informatics team will query the HES database and extract aggregated data directly onto NUH networked drives where the data will also processed and stored. EMAHSN will only use NUH encrypted PCs and laptops and the NUH network drives are only accessible by NUH staff subject to NUH contractual requirements mentioned previously.

EMAHSN will ensure that any outputs have small numbers supressed in accordance with the HES analysis guide, follow NHS Digital guidelines regarding sensitive conditions and state the data source i.e. Hospital Episode Statistics, Health and Social Care Information Centre.

How EMAHSN process the data is dependent on the project, but where it is possible to sense check/validate, EMAHSN do so in order to ensure that any benchmarking/comparisons EMAHSN do make are not in conflict with other recognised publications e.g. replication of a PHE indicator at a finer granularity, or updating the indicator for the latest time period.

Data will not be used for commercial purposes, although industry may use the intelligence provided in analysis to inform development. EMAHSN make charges for data provision on a cost recovery basis only. The funding paid for EMAHSN service is required to deliver the work and should any surplus be generated this would be re-invested into direct delivery of patient care.

No HES data is linked to other sources.

MR1469 - Demographic, morbidity and mortality data associated with the STOP-HCV Cirrhosis Study cohort. — DARS-NIC-72626-V4P9B

Type of data: information not disclosed for TRE projects

Opt outs honoured: No - data flow is not identifiable, No - consent provided by participants of research study, Anonymised - ICO Code Compliant, Identifiable, No (Consent (Reasonable Expectation))

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

Purposes: No (NHS Trust)

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

When:DSA runs 2019-03-08 — 2022-03-07 2019.05 — 2022.08.

Access method: One-Off, Ongoing

Data-controller type: NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST, UNIVERSITY OF GLASGOW

Sublicensing allowed: No

Datasets:

  1. MRIS - Flagging Current Status Report
  2. Hospital Episode Statistics Accident and Emergency
  3. Hospital Episode Statistics Outpatients
  4. Hospital Episode Statistics Critical Care
  5. Hospital Episode Statistics Admitted Patient Care
  6. Bridge file: Hospital Episode Statistics to Diagnostic Imaging Dataset
  7. MRIS - Cause of Death Report
  8. Diagnostic Imaging Dataset
  9. MRIS - Cohort Event Notification Report
  10. Cancer Registration Data
  11. Demographics
  12. Civil Registration - Deaths
  13. Emergency Care Data Set (ECDS)
  14. HES:Civil Registration (Deaths) bridge
  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)
  20. Civil Registrations of Death

Objectives:

This agreement is for a research study on Hepatitis C Virus (HCV) cirrhosis of the liver, which is a sub-study of HCV Research UK (HCVRUK).

HCV Research UK (HCVRUK) is a consortium of many parties across the UK whose aim was to create a cohort of patients infected with the hepatitis C virus (HCV) in order to facilitate research into all aspects of this infection. The project was funded by the Medical Research Foundation (MRF). University of Glasgow's Centre for Virus Research are the Fund Holders and Managing Party and thereby responsible for execution of the Grant on behalf of the MRF. Nottingham University Hospitals NHS Trust are the Clinical Sponsors of the project and their R&I Department oversee the ethical execution of the project and the Principal Investigators for the Biomarker workstrand (of which the cirrhosis study is part) are based there. Thus the University of Glasgow and Nottingham University Hospitals NHS Trust are Joint Data Controllers.

The day-to-day management of the data collected by HCVRUK is conducted by members of the HCVRUK Management Group while Asckey Data Services Ltd hosts the HCVRUK Research Clinical Database on secure systems. The data requested under this agreement will be stored and processed separately to data held by HCVRUK. The data requested under this agreement will be disseminated to and stored by the Robertson Centre for Biostatistics at the University of Glasgow only.

Approximately 12,000 patients have signed a consent form to join HCVRUK. Information including how patients contracted the infection, how long they have had it, any health complications as a result of the infection (including liver disease), and the treatments they receive to clear the infection is collected into a Clinical Research Database, which provides a resource to underpin a variety of specific research studies. Biological samples are stored in the HCVRUK Biobank. Researchers may apply to the HCVRUK Tissue and Data Access Committee (TDAC) for access to data and/or samples. If permission is granted by TDAC, the data/samples are supplied under a Material Transfer Agreement whereby any secondary data (eg generated by experimental manipulation of the biological samples) is returned to HCVRUK.

One research programme supported by HCVRUK is a Medical Research Council Stratified Medicine programme awarded in 2013 entitled Stratified Medicine to Optimise Treatment for Hepatitis C Virus infection (STOP-HCV) (reference MR/K01532X/1). One aim of STOP-HCV is to define the long term clinical outcomes of patients with HCV cirrhosis, including the long-term impact of the recently introduced direct-acting antiviral (DAA) therapy in patients with cirrhosis, and the factors which increase or decrease the risk of cirrhosis progression to life-threatening complications. To that end, a subgroup of around 1200 HCVRUK enrolled patients with HCV cirrhosis have been enrolled, with additional specific consent, into the STOP-HCV cirrhosis study (REC reference 14/WM/1128). STOP-HCV has generated extensive and detailed research data from these patients, including a number of novel diagnostic tests for liver disease progression. This agreement relates to this sub-study only.

For this specific research project the joint Data Controllers are University of Glasgow and Nottingham University Hospitals NHS Trust. Nottingham University Hospitals NHS Trust will provide the cohort identifying data to NHS Digital and University of Glasgow (Robertson Centre for Biostatistics) will receive and process the data from NHS Digital.

The project requires HES, diagnostic imaging, mortality and cancer data for use in the STOP-HCV Cirrhosis study analysis. Data from NHS Digital relating specifically and only to the subgroup of HCV Research UK patients who are also co-enrolled into the STOP-HCV cirrhosis study (about 1,200 individuals) will be used to answer a number of clinically relevant questions. These questions fall into four broad categories:

• Can the new (or existing) diagnostic tests for liver disease progression, be used to predict which patients with HCV cirrhosis liver disease will progress to life-threatening complications (including ascites [fluid in the abdomen], encephalitis [confusion, brain damage], variceal haemorrhage [bleeding] and primary liver cancer) within 5 years of follow up?
• Do new direct acting antiviral therapies for hepatitis C alter long-term clinical outcomes in addition to providing viral cure?
• Do other co-morbidities associated with HCV cirrhosis (especially alcohol and diabetes) result in increased morbidity and mortality from associated conditions such as cardiovascular disease?
• What patient and clinical factors are associated with uptake of liver cancer screening following viral cure? How can compliance to screening interventions be improved.

None of these questions can be robustly answered without complete and reliable data on hospital admissions, cancer diagnoses and death certification. The only mechanism which can provide access to robust and comprehensive data relating to a large and geographically widespread patient cohort is through NHS Digital. Therefore, the data provided by NHS Digital are a critical aspect of delivering on this research.

Processing of the data is in the public interest for a number of reasons. Premature mortality from liver disease in the UK continues to rise and finding better tools to predict which patients are at increased risk of developing cirrhosis complications is essential at an individual and healthcare level. Novel clinical algorithms which will arise from the STOP-HCV Cirrhosis Study will allow individualised clinical management plans, with patients identified at increased risk of disease progression undergoing enhanced surveillance, and therefore achieving earlier diagnosis and treatment of life-threatening complications, whilst those patients at lower risk may be discharged from clinic. In addition to these benefits at an individual patient level, there are likely to be significant health economic benefits. Earlier diagnosis and treatment of potentially life-threatening complications may result in patients not needing to undergo expensive healthcare technologies such as liver transplantation. Appropriate relaxation of cancer surveillance in patients at very low risk will result in less clinic attendances and less surveillance intervention (ultrasound and MRI scanning) costs. Furthermore, this particular study has arisen at precisely the point of introduction of the expensive DAA drugs. Long-term liver-related outcome data, as intended in this proposal, will provide solid data to NHS England on the cost-effectiveness of the DAA revolution in HCV treatment.

The time span of data requested reflects the natural history of clinical events to occur. There are no ethical issues raised by dissemination and the level of data is proportionate to answer the questions posed. There are no foreseeable harmful effects to the public from release and publication of the intended research analyses outlined.

Yielded Benefits:

Using the existing NHS linkage data provided, researchers have completed an analysis to assess the performance of a broad set of biomarkers with respect to predicting the risk of a severe liver-related event in patients with HCV cirrhosis. The biomarkers tested include routine laboratory tests genetic risk scores, and innovative biological markers that measure liver scarring. Ultimately, these biomarkers will help clinicians to identify in advance those patients who are likely to develop severe liver disease outcomes. This analysis is about to be submitted to the Hepatology for publication.

Expected Benefits:

The project aims to develop mathematical risk prediction models for clinical outcomes for patients with HCV-induced cirrhosis which can be adapted into simple clinical management algorithms to enable clinicians to identify both high risk (who may need enhanced surveillance) and low risk (who can be safely discharged from clinic) patients, thereby enabling patients and their doctors to make informed decisions about treatment and follow up.

The measurable benefit of this work will emerge in a time frame of 2-5 years.

From the patient perspective, individualised care plans according to risk stratification will enable early diagnosis of potentially life-threatening complications, which in turn will lead to treatment at a time when curative therapy is possible (especially for hepatocellular carcinoma). It will also allow patients at low risk of disease progression to be managed more conservatively.

From the clinician perspective, it is important that appropriate treatment and surveillance/monitoring is instituted. There is accumulating evidence that although the incidence of liver complications does fall following eradication of the virus, there is still significant residual risk of disease progression in a small percentage of patients. The effect of important co-factors such as alcohol and obesity on clinical outcomes is not yet clear, but prospective cohort studies such as the one proposed herein will answer those questions and allow better patient care. Furthermore, the ability to institute enhanced surveillance for patients demonstrably at high risk of hepatocellular carcinoma should result in earlier diagnosis should tumour development occur in an individual patient. This in turn will improve prognosis as the smaller the tumour at diagnosis, the more likely that curative therapy will succeed.

From the healthcare perspective chronic HCV is estimated to affect approximately 0.5% to 1% of the population (up to 250,000 individuals in the UK). The novel anti-viral agents are expensive. The NHS will want reassurance that investment in new treatments will have an impact on long term clinical outcome and not just on virological cure. Furthermore, earlier discharge from clinic of patients who are demonstrably at no greater risk of disease progression than the general population will have the potential to save significant monies and NHS resources, as without this, all cirrhotic patients are recommended to undergo 6 monthly ultrasound testing and out-patient clinic appointments, essentially for life.

Finally, for the scientific community the proposed analyses will provide important insights into the natural history of patients with HCV cirrhosis, treated with the new regimens, and new areas where treatment of residual liver disease needs to be developed to further improve clinical outcomes (e.g. anti-fibrotic therapy in the context of cirrhosis).

Taken together, the proposed outputs will lead to benefit by producing new diagnostic/prognostic tests which can be used by patients and clinicians. As variables will be used that are already available in routine clinical practice this will reduce the time taken to implement. The proposed work has the potential to have radical and wide ranging benefit: who should be treated, when they should be treated, how patients are monitored and how frequently. The benefactors will range from patients and clinicians to the wider health service. The measurement of benefit will need to occur if and when the new prognostic models have been implemented. To provide two specific examples. Of 100 patients with HCV only 2-3 will develop liver cancer on an annual basis. However, all 100 patients are currently invited for screening tests with ultrasound (costing approx £80-£100 per patient per year). If the specific patients who are at risk could be selected, it would lead to a more rational and effective use of resource. It would also rationalise visits for patients and mean those at risk potentially receive curative therapy at an earlier stage. For the treatment of HCV, if it was found that despite viral cure other factors, such as alcohol and obesity, were leading to adverse clinical events it would stimulate efforts on addressing these factors in achieving long term benefit.

Outputs:

Answers to the aforementioned research questions will further improve understanding of HCV-related liver disease, and thus benefit patient care.

Specific outputs expected to be delivered in the next two years are:
1. Analysis to assess whether change in simple liver blood tests (ALT; AST; bilirubin etc) upon achieving hepatitis C viral cure can predict future occurrence of liver cancer and decompensated liver cirrhosis (completion of analysis, Sept-19).
2. Analysis to assess the relevance of both host and viral genetic variants vis-à-vis risk of liver cancer and decompensated cirrhosis following hepatitis C viral cure (completion of analysis, Sept-19).
3. Analysis to assess whether a polygenomic risk score for coronary artery disease predicts survival, decompensated cirrhosis and liver cancer in patients with hepatitis C viral cure (completion of analysis, Dec-19)
4. Analysis to assess the uptake of 6 monthly ultrasound screening for early detection of HCC following hepatitis C viral cure (completion of analysis, Dec-20)

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

These outputs will be disseminated through two main routes:
(i) Presentation at international liver meetings. Immediate targets are to submit novel findings arising from analysis of the STOP-HCV Cirrhosis study cohort data to the American Association for the Study of the Liver - The Liver Meeting® November 2019 and the European Association for the Study of the Liver International Liver Congress April 2020. The primary audience at the international meetings comprises academics, clinicians and possibly pharma representatives. However, the audience may also include public health physicians and policy makers, especially in light of the impending WHO HCV Elimination agenda.
(ii) Publications in peer-reviewed journals with a high impact. It is anticipated that the first publication will be a description of the characteristics of the STOP-HCV Cirrhosis study cohort ready for submission to the International Journal of Epidemiology. Further publications will relate to the utility or otherwise of a range of novel diagnostic tests in predicting liver disease progression in patients with HCV Cirrhosis. The project plans submissions to the journals Gastroenterology and Hepatology in the second quarter of 2020.

Research outputs will also be communicated to Patients with HCV infection and the general public through the study team's close links with the Hepatitis C Trust who are the largest patient support group in the UK. Members of the Hep C Trust are part of the STOP-HCV Steering Committee and have significantly influenced the research directions of STOP-HCV. They are fully supportive of this application/study and have effective mechanisms for disseminating any advances in the management of HCV infection through an extensive network of patient support groups across the country. In addition, it is the policy of HCVRUK and STOP-HCV to list all publications on their respective websites

The overarching objective of this work will be to inform clinicians, the scientific community, and commissioners of health care of the risks of and factors associated with progressive liver disease in patients with HCV-induced cirrhosis, in order to optimise patient management and healthcare planning.

Processing:

The HCVRUK database contains the details of individuals who consented to participate in the HCVRUK cohort and the STOP-HCV Cirrhosis sub-study. This database contains participant identifiers and details of their HCV infection, liver disease and treatment history.

The HCVRUK database holds the following confidential fields which are never released to researchers: date of birth, initials, soundex of surname, NHS/CHI number. Other personal information that is held and may be released are gender, ethnicity, country of birth and first part of their postcode. All participating sites maintain their own log of patients recruited including full name and NHS or local Hospital ID. This is essential such that within each clinic, data can be added to the correct patient record over time.

Nottingham University Hospitals NHS Trust will securely transfer a file of NHS Numbers, Dates of Birth and Gender plus Unique HCVRUK Study ID for each of the participants of the STOP-HCV Cirrhosis study to NHS Digital (approximately 1,200 individuals).

NHS Digital will subsequently provide linked pseudonymised HES, Diagnostic Imaging Data (DID), mortality and cancer registration data for the identified cohort to the Robertson Centre for Biostatistics at the University of Glasgow including the unique HCVRUK Study ID.

In a separate process, authorised members of the HCVRUK team will create a pseudonymised dataset of the data held within the HCVRUK Clinical database for the same identified cohort and using the same unique HCVRUK Study ID. This dataset will also be securely transferred to the Robertson Centre where it will be stored alongside the NHS Digital data and used to perform the aforementioned analyses, which will include linkage of the data.

Authorised individuals at the Robertson Centre for Biostatistics can access the data supplied by NHS Digital. However, these individuals are only authorised to use the NHS Digital data for those purposes explicitly authorised by NHS Digital and defined in an active Data Sharing Agreement. In addition, one individual accessing the NHS Digital data will be a registered affiliate of the University of Glasgow, and is thus subject to the University’s personal data statement and data protection policies. There will be no requirement/attempt to re-identify patients as the staff at the Robertson Centre will only have access to the unique Study ID whilst the staff working in Nottingham University Hospitals NHS Trust have access to personal identifiers but no access to NHS Digital data. The data from NHS Digital may not be accessed by any other individuals or at any other locations than those at Robertson Centre. NHS clinics participating in HCVRUK will be unable to access the data from NHS Digital for any patient.

The lead statistician, whilst substantively employed by Glasgow Caledonian University, is an affiliate of the University of Glasgow, and will access the data disseminated by NHS Digital under this affiliate status only, and only at the University of Glasgow premises. Individuals with access to the data will not have sufficient security clearance to remove/download any data from the Robertson Centre. All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide, this can be removed from the Robertson Centre, but only if they pass inspection by Robertson Centre staff.

Under this Agreement, the only approved purpose for use of the NHS Digital data is to address the research questions defined.

NHS Digital reminds all organisations party to this agreement of the need to comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract ie: employees, agents and contractors of the Data Recipient who may have access to that data).

MR1006 - Gedling Lung Health Study — DARS-NIC-147783-6T2MW

Type of data: information not disclosed for TRE projects

Opt outs honoured: N, Identifiable (Consent (Reasonable Expectation))

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC, Consent (Reasonable Expectation); Health and Social Care Act 2012 – s261(2)(c)

Purposes: No (Academic)

Sensitive: Sensitive, and Non Sensitive

When:DSA runs 2022-01-05 — 2023-01-04 2018.03 — 2017.05.

Access method: Ongoing, One-Off

Data-controller type: UNIVERSITY OF NOTTINGHAM

Sublicensing allowed: No

Datasets:

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

Objectives:

The data supplied to University of Nottingham will be used for the approved medical research project - MR1006 - Gedling Lung Health Study

Yielded Benefits:

Outputs:

This Agreement permits the secure retention of the data only and no other processing.

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

University of Nottingham have published over 25 research papers using data from this cohort, a list of the publications made since the use of ONS data in 2007 are detailed in the Yielded Benefits. University of Nottingham researchers have been able to combine the dietary details on half of the cohort linked with data from cohort members' GP electronic record and created a database that can be used for research. Together with the data collected in 1991 and 2000 in the face-to-face research visits within the cohort, a rich dataset with which to investigate a wide range of research questions has been obtained, as set out in the University of Nottingham's previous application. The aim is to continue to publish using the GP data on a wide variety of research questions, in particularly on respiratory health effects on long-term survival. The yearly updates on mortality are increasing the ability to examine outcomes of mortality and cancer. Currently the youngest members of the cohort are around 67 years old, meaning an increased likelihood of certain health outcomes for researchers to examine.

Processing:

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

Mortality and cancer registry data are being requested. University of Nottingham have previously supplied the names, dates of birth, and most recent known address of the cohort of people that were originally studies in 1991 to NHS Digital. The NHS Digital data is received and linked to the Gedling cohort dataset. The University of Nottingham are the sole data controller/processor and no other organisations are involved in processing the data.

Data analysis
As describe in this application, data can be analysed using a detailed fatty acid database to produce estimates of individual saturated, omega-3 and omega-6 fatty acid intakes in relation to the prevalence and incidence of common medical diseases linked to diet and obesity including acute respiratory infections, cardiovascular disease (blood pressure, angina, and myocardial infarction), cancers, diabetes, rheumatoid arthritis and liver disease. In addition, the effects of other factors in diet will also be investigated in relation to common medical outcomes. The analyses will be conducted using linear or logistic regression as appropriate and all relations will be explored for the possibility of confounding factors.

NHS Digital linkage
To maximise the number of people from the original cohort identified and followed-up, University of Nottingham used the NHS Digital Medical Research Service (MRIS) to trace all survivors from the original 2,633 cohort members, which was completed in 2007. Where the current address held on University of Nottingham’s systems is correct, as verified by the NHS Digital data, questionnaires (respiratory health and dietary) will be posted directly to the individual. When the current address is incorrect, then the questionnaire will be sent out with a covering letter to the individual via their General Practitioner.

In addition the MRIS service will also identify all deaths in the original cohort and provide information on the cause of death. All living study participants will be flagged for notification of cause of death in the future. Mortality data will be used to investigate the relation between diet and all-cause mortality and between diet and specific causes of death.

NHS Digital already have the cohort population identified and data on deaths and cancer registrations will be sent to University of Nottingham which will then be linked to datasets held at the University of Nottingham on an encrypted hard drive. No data will be shared with individuals/organisations outside the University of Nottingham. All data will be held on an encrypted hard drive.

Project 5 — HDIS_Nottingham University Hospitals NHS Trust

Type of data: information not disclosed for TRE projects

Opt outs honoured: N

Legal basis: Health and Social Care Act 2012

Purposes: ()

Sensitive: Non Sensitive

When:2016.04 — 2016.08.

Access method: Ongoing

Data-controller type:

Sublicensing allowed:

Datasets:

  1. Access to HES Data Interrogation system

Objectives:

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