NHS Digital Data Release Register - reformatted

Manchester University NHS Foundation Trust

Project 1 — DARS-NIC-384524-C7M2Q

Opt outs honoured: No - data flow is not identifiable

Sensitive: Non Sensitive

When: 2016/09 — 2018/12.

Repeats: Ongoing, One-Off

Legal basis: Health and Social Care Act 2012, Health and Social Care Act 2012 - s261 - 'Other dissemination of information'

Categories: Anonymised - ICO code compliant

Datasets:

  • Hospital Episode Statistics Critical Care
  • Hospital Episode Statistics Admitted Patient Care

Objectives:

NHS England has established a Clinical Reference Group (CRG) for burn care services. The CRG includes representatives for areas across England – specifically: North East, Greater Manchester, Cheshire and Mersey, Yorkshire and The Humber, West Midlands, East Midlands, East of England, London NW, London NE, London S, South West, Wessex, Thames Valley and the South East Coast. Specialist burn care services include all burn care delivered by Burn Centres, Burn Units and Burn Facilities delivered as part of a provider network. As a member of the CRG, University Hospital of South Manchester (UHSM) has been commissioned by NHS England to ensure that burn service capacity is adequate for demand across the NHS and specialised services are placed as required in different parts of the country. UHSM is responsible for maintaining the National Burn Registry (NBR) database which is a clinical database containing patient identifiable data on all hospital admissions due to (or including) burns and of the patient treatment and care for each episode. Care providers across England and Wales have an obligation to provide data on burn injuries and the course of treatment given. UHSM use HES data to ensure that the data received from the burn care centres is accurate within agreed thresholds and falls within the scope of data that is required. The scope of the service includes all acute care, rehabilitation and reconstruction. For this reason, UHSM requires HES data that includes plastic surgery codes (160) as well as burn care codes as care is often coded under the specialty rather than burn care (161). It also includes care for severe dermatological skin loss conditions which is why these conditions are included. HES Critical Care data is required as this will show the level of care patients will have received and is within the scope of level of data that burn centres are required to submit to include on the National Burn Registry database. Critical Care is required to ensure that burn care centres are submitting the relevant data to UHSM. It will also allow capacity changes that are expected by NHS England to be necessary in paediatric critical burn care to be modelled. UHSM currently holds HES data from 2002/03-2010/11. This data has previously been used by UHSM to assess the work of the National Burn Care Group, including the designation as specialised services. Further changes to the provider service profile after 2010 need to be assessed using more recent data which will also allow a volume validation against the NBR database. On receipt of new HES data, UHSM will compare the two in order to identify and assess changes to care providers’ service profiles (e.g. age breakdown, length of stay, etc.). Due to changes in the profile the 2002/03-2010/11 data can be compared with the more recent data both for the HES dataset and the Burns registry after processing. Once satisfied that the data requested is correctly assigned to the relevant fields UHSM will destroy the 2002/03-2010/11 data. Data destruction will be completed according to HSCIC guidelines. The data will be destroyed by March 2017 at the latest. UHSM’s role is to ensure that the NBR is an accurate and complete reflection of burns data. Where discrepancies are identified, UHSM notifies the provider and CRG and monitors to ensure corrective action is taken. Providers may challenge or query UHSM’s findings. UHSM may then support providers in identifying the reasons for discrepancies. In doing this, UHSM might provide aggregated figures highlighting specific areas of discrepancy (e.g. age breakdown, length of stay, etc.). Outputs may compare volumes of episodes in HES and the NBR for specific providers but no record level HES data is shared with third parties and the aim is to identify categories rather than individual episodes. Any outputs would contain aggregated data with small numbers suppressed in line with the HES Analysis Guide. UHSM may also receive challenges or queries from NHS England. UHSM will respond to queries using the NBR database but may require HES data to validate findings. In such instances, the outputs will be reports on volumes, potentially categorised by profile (i.e. age breakdown, length of stay, etc.) and no record level HES data will be shared with any third party. UHSM needs to retain the HES data for use in such activities for a rolling period of up to 2 years so that UHSM may run additional completion and quality checks within the timeframe.

Expected Benefits:

The National Burn Registry is used to determine and report the following; • The extent of specialised burn services compliance with their Service Specification. This is delivered annually and due in April. • Quantification of the demand and capacity trends for burn care 2003-2015 to inform the commissioning of service in line with the burn care CRG Strategy 2015-19. This is delivered annually and due in September. These are beneficial to healthcare as CRG use them to make informed recommendations to NHS England in order to ensure that resources are used effectively throughout England and Wales. The intention is to design a sustainable series of burn services throughout the NHS to support safe and appropriate care for this unpredictable emergency workload by use statistical process control (SPC) techniques to look at long term data to compensate for the variation in demand and evaluate the capacity requirements both geographically and at differing levels of provision. The results will enable the distribution of funding to each Trust to ensure that burn service capacity meets the demand across the NHS and specialised services in burn care are placed as required in different parts of the country. Using the HES data will ensure that the calculations are correct for each specific centre and that the results are as accurate as possible. The value of the HES data is in making sure the NBR data is complete/accurate and improving the quality of data collection. These benefits support the wider benefits to health care achieved by using the NBR data. Benefits achieved using the HES data previously supplied have included the recognition of the need for the development of additional Burn facilities in the South East of England and Midlands. See: http://www.londonhp.nhs.uk/publications/london-and-south-east-england-specialised-burns-project/.

Outputs:

The outputs of using the HES data are: 1. Analysis/verification of accuracy and completeness of data in the NBR database. This is undertaken annually. 2. Where discrepancies between the NBR and HES data exceed agreed thresholds, UHSM reports to NHS England via the CRG details of provider(s) responsible for the discrepancies in order for the provider(s) to resubmit data to the NBR with the relevant fields. Should UHSM need to raise discrepancy issues with NHS England than it is simply to point out any numeric mismatches between the HES data analysis and analysis of the NBR database. The two data sources will never entirely match but if the levels of discrepancy exceed agreed thresholds then it is only the simple raw numbers as a tabulated comparison that will be presented to the CRG and NHS England commissioners. It will be at a very simple level because CRG and NHS England only wish to be assured that the NBR database is an accurate reflection of activity and can thus be relied on. Analysis of the HES data is the only form of validation available. 3. Statistical outputs for use in supporting care providers in analysing causes of discrepancies in order to improve completeness of reporting and accuracy of the NBR database. This is undertaken as required on a rolling annual basis. 4. Statistical outputs to be used in responses to specific queries by NHS England. This is undertaken as required. As an example, NHS England intends to undertake specific pieces of work regarding severe paediatric burn injury and providing a highly specialised service for complex skin failure for adults and children. UHSM will be involved in undertaking capacity on demand analysis for these processes using the NBR database with HES validation as required. UHSM expects it will take 6-12 months to complete initial analysis and follow up queries/challenges from NHS England. Following the data completeness checks with the HES data, UHSM reports the results of the analyses of the NBR to the burn care CRG. These results form the basis of the CRG’s recommendations to NHS England concerning service provision to fit in with their strategy for burn care 2014 to 2019. The analysis will identify mismatches between capacity to deal with burns and demand for such services at a national level in addition to geographical areas of mismatch of demand and capacity. The NBR outputs are sent directly to CRG only. These are reported to the CRG in their quarterly meetings and put in the annual report and used as the basis of their recommendations to NHS England. CRG’s outputs will be available to the public, free of charge.

Processing:

UHSM receive extracts of HES data filtered to specific diagnosis codes indicating burn injury, plastic surgery and care for severe dermatological skin loss conditions. UHSM further processes the received data to create a reduced cohort that correlates with NBR inclusion criteria. This process of reduction requires analysis that could not be automated by the HSCIC. UHSM then uses the reduced HES data to verify the accuracy of the NBR data as a representation of burn injury admissions for acute care, for rehabilitation and for late reconstruction. The HES data is compared to data in the NBR and forms the basis of completeness and quality checks. The HES data will not be linked to NBR data or added into the NBR database. Comparison of the workload volumes in the HES data is made against NBR database outputs to ensure that the overall activity numbers and bed days are within acceptable limits. Once the NBR data is within acceptable limits the capacity analysis for each service and geographical area is then carried out strictly in the NBR data to support the commissioning plans for the entirety of burn care in successive commissioning rounds. To clarify, the HES data will not be used for this analysis. Access to the patient level HES data is restricted to only authorised UHSM employees with involvement with the NBR database who need to access the data for the purposes outlined in this application. In addition to comparison of workload volumes, HES data will only be used to answer any challenges that may arise from NHS England or from a care provider. In such scenarios, UHSM may conduct further analyses of the HES data to produce comparisons with NBR data at lower levels. For example, UHSM may produce figures to show numerical differences between the volumes of records supplied by a provider and those derived from HES broken down to age or length of stay in order to highlight where shortfalls or excesses are occurring. All outputs comprise of aggregated data with small numbers suppressed in line with the HES Analysis Guide. UHSM only provides such services in response to challenges raised by NHS bodies. UHSM may undertake analyses of the NBR database using HES data for validation purposes in response to specific queries from NHS England. In such activities, HES data is used only for validation purposes and outputs will contain at most, aggregated data with small numbers suppressed in line with the HES Analysis Guide for the purpose of comparison with statistics derived from analysis of the NBR database.


Project 2 — DARS-NIC-376374-F8D0M

Opt outs honoured: No - data flow is not identifiable

Sensitive: Sensitive

When: 2016/12 — 2019/01.

Repeats: One-Off, Ongoing

Legal basis: Health and Social Care Act 2012, Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii)

Categories: Anonymised - ICO code compliant

Datasets:

  • Hospital Episode Statistics Critical Care
  • Hospital Episode Statistics Admitted Patient Care
  • Hospital Episode Statistics Accident and Emergency
  • Hospital Episode Statistics Outpatients

Objectives:

As a large specialist organisation providing complex care to patients from a broad range of demographic backgrounds the Central Manchester University Hospitals NHS Foundation Trust (CMFT) strives to provide the best care possible for its patients. This entails understanding the complex co-morbidities of its patient population, through which it aims to establish a patient co-morbidity index for the Greater Manchester area. This data will be used for two projects of analytical work: Firstly, benchmarking the Trust against other Trusts to guide their clinical coding improvement strategy. The Business Analyst team will have direct access to HES data to create bespoke, specialty and Health Resource Group (HRG) specific reports. These reports, in their aggregate format, will be shared with other staff at the Trust. They will not be identifiable and small numbers will be suppressed in line with the HES analysis guide. Secondly, the HES data will be used to inform the Trust’s strategic development plans. The information will be analysed to determine areas (geographical by residence, GP practice, CCG etc.) where service provision could be enhanced (e.g. outreach or community clinics). This information will also be used to determine growing/declining service needs of the regional population. The full HES data set is required for this application. This is to allow for analysis across the UK, as the Trust is a national tertiary centre with national tertiary patient services. The Trust compares itself as a whole and individual services to Trusts and services across England. Analysis is at service, site, and HRG level that is not limited to the North West providers. Analysis is ongoing to understand and identify service and HRG level peers. The trust provides a full range of services and therefore requires the full HES dataset requested; other data minimisation efforts are not appropriate. The Trust’s aim is to constantly improve its position as a leading healthcare provider both locally and Nationwide. There are a wide range of patient services that are positioned nationally, for example, the Royal Manchester Children’s Hospital would not suitably compare to the Northwest cohort, whereas the 10 specialist Children’s Trusts across England stretch from Bristol to Newcastle. Similarly, the care that many patients receive at The Royal Eye Hospital is only comparable to that at Moorfields Eye Hospital in London, and the Paediatric Burns Service would compare its specialism to that at Chelsea and Westminster. Analysing the data across the whole country will help CMFT identify the best care outcomes delivered at these similar sites and, from this analysis, work to ensure their services meet their own high standards. Knowledge of output area (OA) and GRIDLINK fields (geographical reference fields) will allow the Business Analytics team to very accurately extrapolate geo-demographic changes occurring within the catchment areas Central Manchester Foundation Trust (CMFT) serves. The Trust will link their existing activity numbers at OA level, to the publically available ONS population prediction statistics. This will enable them to anticipate not only the scale of the demographic growth for demand on services, but also casemix of service needs within specific geographical boundaries. This will enable the Trust to proactively plan for the needs of patients before those needs occur. This way access to NHS services across all acute and specialist services will be improved. Another use of the OA data in HES would support the applicant’s analysis of the local patient population – the percentage of total patient activity which belongs to the Trust. In knowing this, CMFT will be able to investigate the reasons for variation in patient accessing CMFT, whether that be due to ease of transport to their site(s), patient experience or whether they simply don’t provide the services needed. In doing this at OA level, the applicant would be able to understand and plan service expansions (e.g. additional community clinics) which will improve public health and patient access to NHS services.

Yielded Benefits:

HES data has been used to inform reviews into the Trust’s quality of clinical coding and highlight areas of potential performance improvement, looking initially at hospital length of stay. Specifically HES was used for the following: • Analysis of HES data has revealed a significant shortfall in the coding of co-morbidities at the Trust (both regionally and compared to similar hospitals nationally). This finding has prompted a series of coding reviews aimed at capturing these conditions and resulted in more accurate patient records and diagnosis histories. The correct recording of long-terms conditions such as diabetes and asthma, with dementia another condition of particular local importance, enables patients to be assigned more appropriate pathways and treatment, ultimately leading to higher quality care. • HES data is an integral part of the Trust’s recently developed capacity planning model, which will be used on an annual basis for analysing bed requirements. The data from HES are used to provide the length of stay benchmarks used to identify service lines that are significantly different to comparable hospitals. These benchmarks highlight areas of potentially inappropriate or inefficient care, or areas that may be amenable to service redesign and new/better pathways. Whilst it takes time for the results of service change to be fully realised it is expected that focussing on the outlying areas identified through the benchmarking exercise will reduce average lengths of hospital stay, benefiting both the local health economy and patients. Ongoing analysis of HES will be used to track the Trust’s progress in reducing length of stay relative to peers in key areas.

Expected Benefits:

Improving the Trust’s clinical coding develops the accuracy, precision and detail afforded in those policies for the population they serve. The Trust will use clinical coding information to determine disease prevalence rates so as to inform national and local commissioning policy. Any proposed process or service changes are discussed with CMFT's commissioners through established contracting channels (annual contract negotiation process). Any findings derived from the use of the data is shared with commissioners (in aggregated form and small numbers suppressed in line with HES Analysis Guide) to support service changes and local discussions. An example of this would be in Rheumatology, where it was identified that the Trust was not coding a series of comorbidities due to the nursing notes not having the relevant section to record items such as vitamin deficiency or uvetitis. Through local discussions with commissioners based on evidence from the analysis, the local coding/recording policy has changed and as a result the estimated value change has been applied to the 16/17 and 17/18 contract. It also means the patient record accurately reflects the true condition of the patients. This is the direct driver behind one of the applicant’s current Commissioning for Quality and Innovation payments (CQUINS): consistent coding of dental procedures across regional providers. Being able to identify areas where certain procedures and conditions are not being fully captured will ultimately safeguard the patient for any future clinical contact whilst securing the appropriate funding to the practice. It is also a vital factor in maintaining the Trust’s specialist status, which secures the continued provision of specialist care to our patient population. Better understanding the service needs of the Trust’s local and regional population will inform the Trust’s strategic development plans: thus the proportion of activity seen in an appropriate setting, potentially closer to patients’ homes in the community will increase. For example, should a discovery be made that acute asthmatic conditions arriving at A&E or positive screenings/admissions for cancer tend to come from a small number of geographical clusters, the Trust would then be able to run patient education seminars in GP practices or community centres in those localities to raise awareness of asthma self-care or the importance of screening programmes. Both these benefits are key strategic objectives which will take a minimum of 3 years to fully realise. The analysis of the HES data set and coding review has identified a number of areas requiring further investigation and clinical input. An example area was paediatric rheumatology where CMFT have identified a process gap in the Juvenile idiopathic arthritis patient pathway. The Doctor sees the child and identifies the pathway, the child then visits the nurse several times over the next 3 months to receive joint injections to relieve pain. The child is well cared for but the nursing documentation that goes into the notes did not include a section to include comorbidities. CMFT are now in the process of reviewing the medical record following this investigation. Spinal surgery is an area where very poorly children are seen for highly specialist care. Due to the nature of this care not many centres have the skilled workforce to carry the procedures out. As a result a lot of underlying conditions are taken for granted and factors such as wheelchair and stoma status are not always recorded in the notes. This has been highlighted to them and processes are being changed. A&E cases are an area where patients are in for a short time and notes are not always fully completed. The peer data has raised a number of areas that CMFT have been able to focus on and ensure care is taken by the medics to complete key comorbidity recording.

Outputs:

Outputs of analysis are in the form of reports and dashboards, which highlight any pertinent issues relating to the quality of patient care, and provide recommendations regarding the implementation of specific measures to improve efficiency and effectiveness of care. Performance indicators for clinical coding breadth and depth will be created, benchmarking specific services within the Trust with others, within 12 months of access. The Performance indicators for clinical coding breath is still currently in development which will be supported by the continuation of the Agreement. This will be at an aggregate HRG and/or service level with small numbers not suppressed. The audience for these types of reports will be only ever be within the Trust, executive board members, senior directors and management. There will be specialty level reporting for the alerting specialties where multi-disciplinary clinical leads will work with the indicators to ensure recorded case mix appropriately reflects their service. National/regional ‘access’ dashboard will be created detailing the activity conducted across the country, with attention to the North West region, detailing types of services being accessed by which patient groups. This may involve time-lapse geospatial analysis and imaging for specific services and or geographical areas of focus. This will be within 24 months of data access. Data will only ever be presented in aggregate format with small numbers suppressed in line with the HES analysis guide. Reports and dashboards will only be shared within the trust to be viewed by clinicians, managers and informatics staff. No output will be published in journals. A coding review process is now in place, supported by the HES data sets. An example has been provided in the benefits section of this purpose.

Processing:

On receiving the data the data was uploaded by the Informatics department database administrator (DBA) to a ‘HES’ database on a secure SQL server. The server is accessible only within the Trust and access is controlled by permissions linked to Trust user accounts. Permissions to view the HES database are only given to specific Trust employees. Permission requests are received and managed by the Head of Information & Analysis via email to ensure an audit trail of the request. Permissions are only given to a limited and select cohort of the Trusts Business Analysts, within the information department for the purposes set out in this application. The data will not be linked to any other patient identifiable datasets or any other non-identifiable data sets. Informatics specialists then write SQL queries to extract relevant information to their analyses and create new tables within the HES database with the results. Reports and dashboards can link to this data without revealing any of the raw data due to the permissions that have been set. The reports are formatted using a number of different business intelligence tools such as MS Excel and SQL Server Reporting Services (SSRS) reports; depending on the intended audience and the data being analysed. These reports and dashboards are then shared in the trust to help improve the effective delivery of healthcare and the patient experience. This will be in the form of reports, dashboards, and analysis and may be distributed through a number of channels including email, presentations, and papers. Audiences will range from senior management to operational teams. Data in the reports and dashboards will only ever be presented in aggregate format with small numbers suppressed in line with the HES analysis guide. Informatics specialists are based within the Trust’s Business Analytics team and are substantively employed by the Trust.


Project 3 — DARS-NIC-206314-N1N7K

Opt outs honoured: No - consent provided by participants of research study (Consent (Reasonable Expectation))

Sensitive: Non Sensitive

When: 2020/05 — 2020/05.

Repeats: One-Off

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

Categories: Identifiable

Datasets:

  • Hospital Episode Statistics Accident and Emergency
  • Hospital Episode Statistics Admitted Patient Care

Objectives:

Aim/Purpose Data from NHS Digital is requested as part of the PATTErn study to provide record-level information about healthcare utilization for each participant. The purpose of the PATTErn study is to examine the relationship between physical activity (as measured by cardiac devices) and non-elective hospitalisation attendances/admissions (NEHA) in older people with cardiac devices. Our hypothesis is that physical activity tends to decline in the days/weeks leading up to NEHAs. We will be exploring physical activity trends surrounding NEHAs, thus require information about these events in order to perform the analysis. Patients are being recruited from a tertiary care service; therefore, NHS Digital HES data is required as many participants’ local hospital will be elsewhere in the region. Article 6 GDPR justification for processing 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’ All patients participating in the PATTErn are required to provide written, informed consent. This is recorded on the HRA approved consent form. Two sections on the consent for refer to NHS Digital data: 1) ‘I confirm that I have read and understand the Participant Information Sheet dated 13/08/2018 (version 4.4) for the above study and have had the opportunity to consider the information’. - The patient information sheet contains detailed information about collection and use of data from NHS Digital (attached) 2) ‘I understand that information about my hospital attendances in the last 12 months will be collected from NHS Digital. This process will involve sharing of personal details with the NHS Digital service.’ The collection of data from NHS Digital is essential for the completion of the PATTErn study. This is in the public interest as: (1) all participants have expressed willingness of their data to be used as part of the PATTErn study to advance academic knowledge (as evidenced above), (2) results from the PATTErn study will advance academic and clinical knowledge and understanding of the relationship between PA and hospitalisation events and (3) results from the PATTErn study will in likelihood lead to either further clinical studies or direct change in clinical service provision with the aim of improving patient care. Article 9 GDPR justification for processing 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. As laid out above, data processing is in the public interest for the benefit of health and social care. Safeguards to protect data subjects are in place as per University of Manchester data security and data protection policies (see processing activities). How will the data requested achieve the aim identified? NEHA data from NHS Digital will allow us to investigate the relationship between physical activity and non-elective hospital attendances/admission. This is the core aim of the PATTErn study. NHS Digital data will provide dates and information about NEHAs. NEHA ‘events’ will be added to participant timelines to facilitate temporal trend analyses. Background to Study The PATTErn study is a stand-alone study. It is sponsored by the University of Manchester, and forms the central part of a PhD. PATTErn is an observational research study with full HRA approval (granted 18th June 2018, substantial amendment approval granted 1st October 2018) which opened for recruitment on the 12th October 2018. the Phd is being carried out by a substantive employee of the University of Manchester. The PATTErn study is a stand-alone study. It is not part of a wider project or collaboration. No follow-up work is currently planned. NHS Digital data collected as part of this application will be used as described above for the PATTErn study only. Data Subjects Recruitment target is 150 participants (it is anticipated recruitment will extend above this target). There is a single cohort. Inclusion criteria identify patients over the age of 60 under follow-up at Manchester Heart Centre with a Medtronic cardiac device in situ for > 6 months, which has the capacity to monitor physical activity. Patients must be able to provide written, informed consent in the English language. Purpose of Request The purpose of this project is to investigate physical activity patterns in older people with cardiac devices, and how these correlate with non-elective hospitalisation events. I. Data regarding (1) non-elective hospital attendances and (2) non-elective hospital events is required to provide the ‘outcome’ data for this study. II. Information regarding the dates of these events is required to facilitate predictive modelling. III. Data is required to be identifiable so we can link events with each study participant. IV. Data for the 12 months prior to date of recruitment is required as per study protocol and patient information sheets/consent forms. V. There are no less intrusive ways of achieving this data reliably. It is not feasible to rely on patients to remember dates of hospital attendances. Organisations involved in study 1. University of Manchester (sole data controller and data processor) Role: sponsor of study Data remit: facilitate transfer of data from NHS Digital, storage, processing and analysis of data 2. Manchester University NHS Foundation Trust (MFT) - **note previously known as Central Manchester NHS Foundation Trust** Role: study site Data remit: MFT will not receive any NHS Digital data. It will, however, provide study participant identifiers to NHS Digital, as this is where personal data from study participants is collected and stored, including the enrolment log, which links personal information with the study participant number (SPN). MFT will not have access to disseminated NHS Digital data. 3. Medtronic Inc Role: funding the post of Principle Investigator and some research costs associated with the study (from April 2018-April 2019) Data remit: Medtronic have no access to any of the NHS Digital data. It is not involved in this aspect of the study. Medtronic's role in the study is to facilitate processing of pseudo anonymised device downloads. 4. British Heart Foundation Role: funding the post of Principle Investigator (BHF Clinical Research Training Fellowship) and some research costs associated with the study (from April 2019 – April 2021) Data remit: The BHF have NO ACCESS to identifiable data or NHS Digital data. It is not involved in this aspect of the study. Will assist in dissemination of results. The PATTErn study is not being undertaken for commercial purposes, however there is commercial involvement in the study. The PATTErn study is an academic study, forming part of the PI's PhD. The PI's post at Manchester University is funded by Medtronic - a company which manufactures cardiac devices. Funding from Medtronic ended in April 2019 when funding was taken over by the British Heart Foundation. Funders have no influence over study results or outputs generated. Funders have no access to NHS Digital data.

Expected Benefits:

The main benefit of this study will be improved knowledge of the association between physical activity and hospitalization events in older people with cardiac devices. This will be of benefit to health and social care as outlined below: Researchers: Improved knowledge in this research area opens up new avenues of research within the field of ageing/heart failure research. If physical activity from cardiac devices is shown to correlate with hospitalization events, this may justify future studies investigating the impact of interventions based on this data e.g. physical rehabilitation, referral to Geriatric Medicine services. The PI will submit the results of the study as part of her PhD. Target date: PhD end date, November 2021, future research strategy plan January 2022. Clinicians: A greater understanding of the significance of physical activity data from cardiac devices will help health professionals make the best use of cardiac device data to serve their patients. For example, this study may lead to a greater emphasis on recording and reviewing activity data during routine device reviews. Further, down the line, this may lead to service improvements projects using activity data as a trigger for signposting to services such as community physiotherapy or exercise groups. Target date: Dissemination of work to improve knowledge of relevant health professionals: October 2021. Patients: This work will hopefully lead to improved patient care. This may not occur as a direct result of this study, rather further down the line as results inform service improvement projects. Participants in the study whom have consented to receive information on study results will be better informed on the significance of physical activity, and effort will be made to emphasize the importance of physical activity for the maintenance of heath and function. Recruitment aim = 150 patients. Target date for postage of lay summary to participants: April 2021 As per section 5(c) only patients able to consent in the English language are eligible for recruitment into the study, and all research outputs will be published in the English language only. The impact of this is that participation in the study and availability of results will be restricted to English speaking patients/members of the public. The benefits of the study may not be able to be extrapolated to reflect the broader population as the study has focused on a patient cohort who are able to provide written, informed consent in the English language.

Outputs:

Dissemination of Results When processing is complete, outputs will include: 1. Submission to peer review journal. The UoM supports open access publication. 2. Presentations at: a) Internal meetings at UoM and MFT b) Seminars and workshops at academic events (where appropriate) c) National and international academic conferences d) Patient engagement events 3. A ‘lay summary’ of results for study participants and interested non-academic parties. This is anticipated to take the form of a 2-page pdf document, which will be disseminated via: a) letters/emails to study participants b) PATTErn study webpage on publicly accessible UoM website c) British Heart Foundation literature/website/online publication 4. Reports to: a) UoM – in form of progress reports (study sponsor), PhD thesis and coursework b) British Heart Foundation – in form of progress reports (study part-funder and PhD fellowship funder) c) Medtronic Inc. – in form of progress reports (study part-funder) The target time for release of these outputs is April 2021. Level of data contained in outputs The majority of outputs will contain only aggregate level data with small numbers suppressed in line with HES analysis guide. Some ‘case study’ timelines for individual participants may be published to visualise the association between physical activity and non-elective hospital admission/attendance events – however all dates will be removed (dates replaced with timeline of day 0-365) and no data will be presented which could directly identify the individual e.g. specific details of reasons for hospital attendance/admission or multiple co-morbidity data. This is considered essential for displaying the clinical significance of activity data. Dissemination and communication approach Through the outputs stated above, the results of the PATTErn study will be disseminated to target audience of researchers, data scientists, academic groups, innovative technology-focused organisations and research participants. The British Heart Foundation (BHF) has established links with a wide variety of communities – and will help ensure output is brought to the attention of policy makers. Communication channels will include Academic channels – peer review journal manuscripts, presentation at conferences Website and newsletters – via UoM, BHF and MFT Open lectures and talks – public promotion of results via the Manchester Institute for Collaborative Research on Ageing (MICRA). We will present the results of the PATTErn study at at least one MICRA event. Exploitation of results/outputs The UoM has a research collaboration agreement in place with Medtronic outlining data and knowledge ownership and access rights. In line with UoM postgraduate research policy, all newly created knowledge, tools or technologies will be under the ownership of the UoM. Results will be shared with all stakeholders (including Medtronic) as stated above in ‘Level of data contained in outputs’. Funders will have no influence on the study results. As part of the study inclusion/exclusion criteria, patients must be able to provide written, informed consent in the English language in order to be recruited. This restriction was put in place primarily due to the lack of resources at the recruiting site to (a) provide a service to translate all study documents and (b) provide a face-to-face translator for study consent and assessment. Outputs will be published in the English language only. These factors will restrict participation and dissemination of work to English speaking members of the public. The impact of the English language only consent on the outputs of the study is that they may well be limited to only reflecting outcomes for a cohort of patients who are able to provide written, informed consent in the English language and the benefits of the study may also be limited to this cohort and may not be able to be extrapolated across to reflect the broader population.

Processing:

Sharing of identifiable data from participants with NHS Digital is included in the Participant Information Sheet (which all participants must confirm they have read before consenting to participate), and is explicitly stated (with corresponding participant initials) on the consent form. Data Flows Information transferred to and from NHS Digital will be record-level, directly identifiable patient data. Personal data for each study participant will be provided to NHS Digital by the study site - Manchester University NHS Foundation Trust (MFT). This data will be Study ID (unique 6-digit number) and personal identifiers only: NHS Number, Date Of Birth, Gender, Postcode. NHS Digital data will then be provided to the study sponsor - the University of Manchester. Data will be received directly into the Data Safe Haven (see below). The output of NHS Digital data received will be record-level. Data will be tagged with study participant number (SPN), and personal identifiers (NHS Number, Date of Birth, Gender, Postcode). Disseminated data from NHS Digital will not be shared with any other organisation (including MFT and Medtronic Inc). Medtronic Inc role is the funding the post of Principle Investigator and some research costs associated with the study they have a remit to facilitate processing of pseudonymised device downloads. No access to identifiable data or NHS Digital data is permitted the information is limited to that of the device information. The Data Safe Haven (DSH) NHS Digital data will be received via the Data Safe Haven (DSH) at the University of Manchester (UoM). Access to the DSH is only granted to substantive employees of the UoM whom have completed the University’s Data Protection Training and authorised by the Research Governance, Ethics and Integrity team (RGEIT). Each DSH user has a project file within the DSH, which is accessible to that user only. Access to the Data Safe Haven is restricted to on-campus connectivity only. Only the Principal Investigator (PI) and Study IG Lead are authorised to move data in or out of the DSH. Any person in addition to the PI or study IG lead requesting access to the PI’s project folder within the DSH will require approval by either the PI or study IG lead, and authorisation by the RGEIT. No personnel outside the direct employment of the University of Manchester will have access to the NHS Digital data. NHS Digital data is downloaded into the DSH via a single point - a static IP addressed laptop within the RGEIT office. For this study, NHS Digital data will be downloaded by the PI. The PI will create a separate password-protected sub-folder within their project folder, which can only be accessed by either the PI or Co-study IG Lead. After logging on to the laptop with their UoM username and password, the PI will access the DSH using the University’s 2-factor authentication Service (Duo) to verify their identity. Data from NHS Digital is transferred into the separate password-protected sub-folder in PIs project folder within the DSH using the Secure Transfer Service. One the data is stored; this will be manually reviewed by the PI to ensure there are no obvious issues with the data. The PI will then create a separate pseudonymised data file, removing all personal identifiers, leaving the SPN as the only record-level identifier. Once this pseudonymised data file is checked and authorised by both the PI and Co-study IG Lead, the original NHS Digital data file will be destroyed. Identifiable participant data will not leave the DSH. The pseudonymised NHS Digital data file will be stored within the PI’s project file in the DSH. Here it will be combined with other study data to create a pseudonymised research database for analysis. This data includes: NHS Digital data for each participant. This will be combined with data collected from: 1) The participant directly using study questionnaires and physical assessments (recorded onto the case report form) 2) Cardiac device data (SPN-coded) 3) Data from medical records (recorded onto case report forms) The pseudononymised research database will remain within the DSH. The pseudonymised research database will be used for the majority of all analysis. Data will then be used to analyse temporal trends in physical activity surrounding non-elective hospitalisation episodes. Analysis will be performed using software within the DSH (mainly Excel, SPSS, R, GraphPad). Data Flow out with the DSH In order to facilitate the movement of data out with the DSH, an anonymised research database will be created within the DSH. Anonymization will take place in line with ICO guidance. Any data leaving the DSH will be reviewed by either the PI or study IG lead to ensure it is compliant with UoM guidance, HES analysis guidance and ICO anonymization guidance all releases of data will be aggregated with small numbers suppressed in line with the HES analysis guide. No NHS Digital data will be transferred outside the UK. Data Linkage NHS Digital data will be combined with data collected as part of the PATTErn study as stated above and explained in the patient information sheet. It will not be linked with any other databases. Study Participant Data Anonymity Once data has been pseudonymised the identifiers will be securely destroyed and there will be no attempt to re-identify individual participants. Additional Information One aspect of the study will take place out with the UK; however, this will not involve NHS Digital data. Pseudonymised cardiac device download files require processing by the Medtronic technical team whom are based in Maastricht, the Netherlands. These files will be transferred across and back using an online encrypted transfer service. This data will then be added to the pseudo anonymised research database at the University of Manchester. This process does not involve any NHS Digital data. 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 ie: employees, agents and contractors of the Data Recipient who may have access to that data).


Project 4 — DARS-NIC-204376-Y0V5Y

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

Sensitive: Non Sensitive, and Sensitive

When: 2020/01 — 2020/01.

Repeats: One-Off

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

Categories: Identifiable

Datasets:

  • Hospital Episode Statistics Admitted Patient Care
  • Hospital Episode Statistics Outpatients
  • Hospital Episode Statistics Critical Care
  • Hospital Episode Statistics Accident and Emergency
  • HES:Civil Registration (Deaths) bridge
  • Civil Registration - Deaths

Objectives:

Modern day pacemakers not only treat slow and fast heart rhythms but also have the ability to detect key changes in the patient’s overall condition that can help identify patients who may be suboptimally managed or unwell. The health care team in this unit at Manchester University Hospital NHS Foundation Trust (MUFT) analyses data from patients with Medtronic implanted cardiac devices on remote follow-up. This is collected by transmitting downloads from home via CareLink, an internet based service which allows doctors to remotely monitor an implantable cardiac device and monitor the care of patients managed by the service. MUFT use the results to improve the care delivered to patients. This process is called service evaluation. This particular service evaluation is called Triage-HF Plus and the purpose of the evaluation is to improve patient pathways and guide future models of care for patients followed up by remote monitoring. ‘Triage HF Plus’ is a new clinical pathway which was implemented at MUFT in June 2016. This evaluation was discussed with the Health Research Authority (HRA) at time of onset and was designated as a non-research study as the aim was to evaluate current care. The evaluation started in June 2016, and MUFT now have 3-years of cardiac device data available. The pathway dictates all patients who perform a transmission from home which is calculated to have a high ‘Heart Failure Risk Score (HFRS) are contacted by telephone to establish if they have any symptoms. If patients have symptoms of worsening heart failure after telephone assessment they are deemed ‘triage positive’, and if not, ‘triage negative’. Clinical action is then taken directly at the time of phone call. Patients with a low- or medium- HFRS are managed as per their usual care plan. In order to provide essential outcome data to evaluate the impact of this new clinical pathway, MUFT require additional short– and medium- term health care utilisation and death data for all patients with devices facilitating remote-monitoring at MUFT during the evaluation period (21st June 2016 to 21st September 2018). Using the existing clinical data from patients with a HFRS enabled device, linked to NHS Digital Hospital Episode Statistics (HES) data, MUFT and academic partners based at the University of Manchester (UoM) will examine i) adverse outcomes at 30- and 90-days (all-cause hospitalisation, heart failure hospitalisation, mortality) ii) adverse outcomes at 12-months. This longer-term data will help MUFT evaluate the safety of the pathway, and help guide future changes to the pathway (for example, intensifying monitoring for high HFRS patients, and relaxing face-to-face monitoring frequencies for low HFRS patients). iii) Examine healthcare utilisation across the different Heart Failure Risk Score groups (this will require access to outpatient data as well as data for hospitalisation/death/use of outpatient services in the 12 months prior to implementation of the pathway. (iv) Examine healthcare utilisation for ‘Triage-positive’ and negative cases This falls under the medical purpose in s251 as defined as a ‘medical diagnosis’ for the provision of care and treatment. The data requested from NHS Digital will be used solely for this project. Results will be published in a peer-review medical journal, and presented at conferences. Results will likely feed into a bigger programme of service improvement by better use of cardiac device remote monitoring systems. No elements of this work are taking place outside of England/Wales. The data requested is justified under Article 6(1)e of the General Data Protection Regulation. The collection of data from NHS Digital is essential to provide robust outcomes data for patients managed by the new pathway in order to establish if outcomes are improved. This is in the public interest as: (1) results from the Triage-HF Plus evaluation will advance academic and clinical knowledge regarding the true utility of health-related data, obtained from implanted devices, to complement the monitoring of heart failure stability, (2) whether managing patients using the Triage-HF Plus pathway results in improved care and outcomes for patients, (3) results from the Triage-HF Plus evaluation may lead to either further clinical studies or direct change in clinical service provision with the aim of improving patient care. The data requested is justified under Article 9(2)h of the General Data Protection Regulation. As laid out above, processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services (see processing activities). Hospitalisation, healthcare utilisation and mortality data from NHS Digital will allow MUFT to investigate the impact of the Triage HF Plus clinical pathway. NHS Digital data will provide dates and information about hospital attendances, admissions, Outpatient attendances and deaths. These events will be added to timelines at an individual record level to facilitate predictive modelling. Background to the evaluation Triage HF Plus (Identifying and Managing Heart Failure Episodes In Ambulatory Patients With A Cardiac Implantable Electronic Device (CIED) Using Device Based Diagnostics and Automated CareLink Alerts) is a non-research, service evaluation project. At the Trust, Medtronic CareLink transmissions from the ambulatory Cardiac Implantable Electronic Devices (CIED) population are routinely reviewed as part of standard clinical practice and this practice is endorsed by international guidelines. All patients have provided written informed consent ahead of enrolment onto the CareLink remote monitoring network and patients provide verbal informed consent to having their CareAlerts (capable of generating automatic alerts) enabled. CareAlerts are a functionality of the device that need to be enabled in order for alerts about abnormal health-related data to be sent electronically to the clinical team. In patients where alerts have not been enabled, no alert will be sent to the clinical team. Patients will have attended a face-to-face visit to have these alerts enabled as part of routine care at some point during their follow-up. Advances in heart failure diagnostics mean that it is also possible to identify patients at risk of worsening heart failure using health-related data recorded by the CIED. The Medtronic ‘Heart Failure Risk Score’ (HFRS) is an algorithm that uses input from health-related data recorded by the CIED stratify patients as low-, medium- or high-risk of a heart failure event in the next 30 days. Since June 2016 MUFT have been using HFRS-based alerts for the remote identification of worsening heart failure in the population of CIED patients who are enrolled on the CareLink platform. The Research and Innovation department at Manchester Foundation Trust reviewed the service evaluation proposal to respond to Medtronic CareLink HFRS-based alerts and approved the use of the One Clinical Service database as a data collection tool to support the evaluation. One Clinical Service (operated by Medtronic) is a secure care management service/ database that pulls data from the 'cloud' where device-related data sits. Using OCS clinicians can view physiological data and add clinical data in a secure environment. The hospital is the data controller, while Medtronic is the data processor on behalf of the Hospital. On the basis that MUFT routinely respond to CareLink alerts in the existing practice, the Triage HF Plus service evaluation represents an extension of the existing clinical service. High-risk HFRS alerts prompt a telephone consultation with the patient, using the information provided by the remote transmission and patient reported symptoms appropriate clinical actions in line with clinical guidelines are instigated – this has become known as the ‘Triage-HF Plus pathway’. Service evaluation has so far confirmed the Triage-HF Plus pathway appears to accurately identify patients whom would benefit from a telephone assessment of heart failure stability and general health. Purpose of Request The purpose of this evaluation is to evaluate the Triage HF Plus pathway for the remote monitoring of heart failure stability and establish the accuracy of the pathway to predict adverse events and healthcare utilisation. I. Data regarding (1) non-elective hospital attendances and (2) non-elective hospital admissions (3) Outpatient attendances and (4) death are required to provide the outcome data for this evaluation. II. Information regarding the dates of these events is required to facilitate predictive modelling. III. Data is required to be identifiable so MUFT can link events with each individual in order to facilitate predictive modelling. IV. Data for the 12 months prior to date of enrolment in the pathway is required to examine healthcare utilisation associated with implementation of the Triage HF Plus clinical pathway. V. There are no less intrusive ways of achieving this data reliably. Proposed use of data Recognising that remote monitoring of health-related data derived from CIEDs offers the potential to reconfigure clinical services based on their clinical condition, MUFT wish to examine health care utilisation (HCU) and mortality in the low-, medium- and high-HFRS groups to examine and validate the current care pathways and to assist in the development of future state care pathways. In view of this consideration, MUFT are applying to collect -12 month, +30 day, +90 day and +12 month outcome data (elective / non-elective hospital attendances and mortality) for the patients enrolled in the evaluation. Cohort MUFT have approximately 500 patients at the trust who are implanted with HFRS enabled devices capable of stratifying the risk of heart failure events based on health-related data, who have consented to remote monitoring using the CareLink platform. Section 251 support is also in place to facilitate linkage with HES and Civil Registration Death data. The section 251 approval allows the flow of the following identifiers to flow from Manchester University NHS Foundation Trust to NHS Digital. NHS number Date of birth Sex Postcode As MUFT is a tertiary cardiac centre serving the wider area of Greater Manchester, East Cheshire and Lancashire, MUFT require central NHS Digital data to accurately establish local hospital attendances. MUFT also require civil registration data from NHS Digital as this is more reliable than mortality data collected at MUFT. Support sought MUFT are requesting time limited access to allow NHS Digital to undertake linkage of existing data held by the clinical team to HES /Civil registration data to collect follow-up / additional data on an existing dataset that is already held by the trust. By linking the two datasets MUFT will obtain additional information to help develop future state care models for CIED patients enrolled in remote monitoring programs. The Confidentiality Advisory Group and Secretary of State for Health and Social Care have considered the application at the precedent set CAG and have authorised Time Limited Access to undertake the record linkage/ sample validation and to anonymise the data. MUFT have engaged informally with NHS Digital who will act as a third party to carry out data linkage and confirmed the minimum data identifiers required to undertake the linkage. Organisations involved in evaluation 1. Manchester University NHS Foundation Trust (MUFT) - **note previously known as Central Manchester NHS Foundation Trust** Role: (i) Sole data controller (ii) Data processor Data remit: Provide Participant ID Numbers (PIDN) and patient identifiers to NHS Digital to facilitate linkage. * NHS Number * Date of Birth * Gender * Postcode NHS Digital will return a pseudonymised extract linked HES-Civil Registration Deaths to MUFT. The data sent by NHS Digital does not need to be re-identified once received back by MUFT. MUFT have already prepared a pseudonymised clinical dataset (device and medical record data) which will be analysed along side the pseudonymised datasets returned from NHS Digital. Both datasets use a unique random 6-digit PIN that can be used to link the two datasets. This avoids the need to re-identify any data. MUFT will only be handling pseudonymised (de-identified) data from this point forwards. MUFT will also facilitate the transfer of psuedonymised data to and from NHS Digital, storage, processing and (in part) analysis of data. 2. University of Manchester Role: Data processor Data remit: Analysis of pseudonymised research database. UoM will receive psuedonymised NHS Digital data and this will be transferred via MUFT (data controller). 3. Medtronic Inc Role: Providing patient level data concerning health-related data from Medtronic CareLink platform prior to linkage by NHS Digital. Data remit: Medtronic have no access to any of the NHS Digital data. It is not involved in this aspect of the data processing. Medtronic's role in the evaluation is to provide Heart Failure Risk Status (HFRS) data to MUFT. As such Medtronic is neither a data controller or data processor within this agreement. Should their role change the agreement will require an amendment to NHS Digital and necessary approvals sought. This agreement covers data for the cohort of participants covered by Section 251 approval.

Expected Benefits:

The main benefit of this evaluation study will be a greater understanding of the utility of a combined HFRS/telephone triage service i.e. the Triage HF Clinical Pathway to identify patients at risk of 30-day hospitalisation or death. If results show good diagnostic utility (and The health economics evaluation confirms low burden on implementation) – this may contribute to a change in national guidance – upgrading recommendations to more strongly supporting this strategy is incorporated into routine clinical practice. If results show poor diagnostic utility, this may contribute to a downgrading of current guidance. On a local level, results will help MUFT to adapt the current service provided to cardiac device patients to improve care. For example, if patients are being admitted to hospital within 30 days of a high alert despite feeling well at the time of alert, MUFT may implement a new pathway streamlining all patients to have a face-to-face clinical review. This will benefit patients by improving patient care, and the NHS by evaluating the best service delivery. MUFT anticipate it would take 2-3 years to fully implement and evaluate significant new changes. Another benefit of this study will be improved knowledge of the utility of the Triage-HF Plus clinical pathway as a pragmatic screening tool to identify patients at increased risk of hospitalisation. This will be of benefit to health and social care as outlined below: Researchers: Improved knowledge in this research area opens up new avenues of research within the field of device/heart failure research. If device data is shown to accurately identify patients at increased risk of heart failure hospitalisation then this may justify modifying clinical pathways and facilitate the rapid scale up implementation of this pathway across the UK. Publication and dissemination of data is expected to commence in May 2021. Clinicians: A greater understanding of the significance of health-related data from cardiac devices will help health professionals make the best use of cardiac device data to serve their patients. For example, this study may lead to a greater emphasis on enrolling patients onto remote monitoring platforms to enable abnormal results to be reviewed by clinical teams. Target date: Dissemination of work to improve knowledge of relevant health professionals: May 2021. Patients: This work will hopefully lead to improved patient care. This may not occur as a direct result of this evaluation, rather further down the line as results inform service improvement projects.

Outputs:

Results will be submitted to peer-review journals and presented locally at meetings, and at national/international conferences. Local meetings, held in Greater Manchester, will be attended by clinicians, healthcare practitioners, healthcare scientists, clinical managers, heart failure charities and patients. No data presented will be identifiable. Small numbers will be suppressed in all outputs in line with the HES analysis guide to avoid risk of re-identification – any data with less than 5 patients will not be shown. Interested audiences will be health professionals – but will not be restricted i.e. results will be available to the public. Dissemination of Results When processing is complete, outputs will include: 1. Submission to peer review journal. 2. Presentations at: a) Internal meetings at UoM and MUFT b) Seminars and workshops at academic events (where appropriate) c) National and international academic conferences d) Patient engagement events 3. A lay summary of results for patients and interested non-academic parties will be placed on the Research Webpage for Manchester Heart Centre. a) letters/emails to study participants b) MUFT, Health Innovation Manchester, UoM and on publicly accessible websites c) Results may be disseminated in the form of progress reports for interested parties (may include Dr Taylor’s PhD thesis). The target time for release of these outputs is May 2021. Level of data contained in outputs All outputs will contain only aggregate level data with small numbers suppressed in line with HES analysis guide. Some case study timelines for individual participants may be published to visualise the association between health related device data and non-elective hospital admission/attendance events however all dates will be removed (dates replaced with timeline of day e.g. 0-365) and no data will be presented which could directly identify the individual e.g. specific details of reasons for hospital attendance/admission or multiple co-morbidity data. This is considered essential for displaying the clinical significance of device data. Dissemination and communication approach Through the outputs stated above, the results of this evaluation will be disseminated to target audience of researchers, data scientists, academic groups, innovative technology-focused organisations and research participants. Health Innovation Manchester (HInM) has established links with a wide variety of communities and will help ensure output is brought to the attention of policy makers and industry collaborators. Communication channels will include Academic channels peer review journal manuscripts, presentation at conferences Website and newsletters via UoM, (Health Innovation Manchester (HInM) and MUFT Open lectures and talks public promotion of results via HInM public engagement meetings. MFT clinicians and academics will present the results of this Triage-HF Plus evaluation at at least one cardiology congress. Exploitation of results/outputs MUFT has a research collaboration agreement in place with Medtronic outlining data and knowledge ownership and access rights. Results will be shared with all stakeholders (including Medtronic who have supplied the health-related data from implanted devices) but Medtronic will only see aggregated outputs of the NHS Digital data. Stakeholders will have no influence on the evaluation results.

Processing:

NHS Digital data will be linked with individual patients in the study cohort by Participant ID Number (PIDN). Both datasets use a unique random 6-digit PIDN that can be used to link the 2 datasets. This avoids the need to re-identify any data. Manchester University NHS Foundation Trust (MUFT) will act as the co-coordinating organisation. MUFT will provide NHS Digital with identifiers alongside corresponding PIDN for each patient in the cohort, and receive in return NHS Digital data linked with PIDN. No data will flow to other organisations not noted in this agreement or outside the UK. All organisations party to data sharing 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 ie: employees, agents and contractors of the Data Recipient who may have access to that data). Sharing of a minimal identifiable data set from participants with NHS Digital is outlined in the approved CAG Section 251 application. Using information booklets and posters in waiting rooms MUFT have stated the plans to use routinely collected health-data from implanted devices to inform the development of new data-driven, technology enabled remote monitoring pathways for patients with heart failure who also have implanted devices. Data Flows Information transferred to NHS Digital will be record-level, directly identifiable patient data. Data received from NHS Digital will be record-level pseudonymised data. Personal data for each study participant will be provided to NHS Digital by the data controller (Manchester University NHS Foundation Trust, MUFT). Data transfer will occur via an encrypted data transfer service. This data will be PIDN (unique random 6-digit number) and personal identifiers only: NHS Number, Date of Birth, Gender, Postcode. Linked NHS Digital data will then be provided to the data controller (MUFT) via an encrypted transfer system. The output of NHS Digital data received will be record-level. Data will be analysed with PIDN only. Disseminated pseudonymised data from NHS Digital will only be shared with named individuals working at MUFT, and the academic collaborators at UoM. Data will not be transferred to any other organisation. A dataset with aggregated data with small numbers suppressed will be made available and will be viewed by collaborators outwith MUFT and UoM for the purpose of supported analysis. The collaborator is Medtronic, who are supporting the health-economic analysis of the new clinical pathway. Data Safe Haven (DSH) Pseudonymised NHS Digital data processed by the data controller (MUFT) will be received via the DSH at the University of Manchester (UoM) where additional processing and analysis can be undertaken. Access to the DSH is only granted to substantive employees of the UoM whom have completed the Universities Data Protection Training and authorised by the Research Governance, Ethics and Integrity team (RGEIT). Each DSH user has a project file within the DSH, which is accessible to that user only. Access to the DSH is restricted to on-campus connectivity only. Only named individuals are authorised to move data in or out of the DSH. No personnel outside the direct employment of the University of Manchester will have access to the processed NHS Digital data. NHS Digital data is downloaded into the DSH via a single point - a static IP addressed laptop within the RGEIT office. For this evaluation, NHS Digital data will be received by the data controller (MUFT). The data controller will create a separate password-protected sub-folder within their project folder on the MUFT server, which can only be accessed by named individuals. Once the data is stored; this will be manually reviewed to ensure there are no obvious issues with the data. Here it will be combined with other evaluation data to create a pseudonymised research database for analysis. This data includes: NHS Digital data for each participant. This will be combined with data collected from (1) Cardiac device data and (2) Data from medical records (stored in pseudonymised database) to create a pseudonymised research database. The pseudonymised research database will remain within the MUFT and UoM. The pseudonymised database will be used for all analysis. Once this pseudonymised data file is checked and authorised the original NHS Digital data file will be destroyed. The pseudonymised research database will be transferred from MUFT to UoM via the DSH. After logging on to the laptop with their UoM username and password, the named academic analysts will access the DSH using the University’s 2-factor authentication Service (Duo) to verify their identity. Data is transferred into the separate password-protected sub-folder in PIs project folder within the DSH using the Secure Transfer Service. Record level data will not leave the DSH/MUFT secure servers. The pseudonymised NHS Digital data file will be stored within a secure project file in the DSH. Data will be stored in the DSH until such time that all peer-reviewed publications have been disseminated and the clinical team are confident that no further analysis will be required (maximum storage 10 years). Data analysis will be performed using software within the DSH (mainly Excel, SPSS, R, GraphPad). No NHS Digital data will be transferred outside England and Wales. NHS Digital data will be combined with data collected as part of the TRIAGE evaluation project as stated above. It will not be linked with any other databases. Outside MUFT, it will not be possible to re-identify individuals based on data provided. Access to the key linking PIDN and patient identifiers will be kept securely at MUFT with access granted to named individuals only. This file will be destroyed once all data analysis is complete and results disseminated and peer review complete.