NHS Digital Data Release Register - reformatted

University Of Warwick projects

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

🚩 University Of Warwick was sent multiple files from the same dataset, in the same month, both with optouts respected and with optouts ignored. University Of Warwick may not have compared the two files, but the identifiers are consistent between datasets, and outside of a good TRE NHS Digital can not know what recipients actually do.

Observational study of Age, test THreshold and frequency on English NAtional Mammography screening outcomes — DARS-NIC-656870-H0K0G

Type of data: information not disclosed for TRE projects

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

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

Purposes: No (Academic)

Sensitive: Sensitive

When:DSA runs 2024-06-03 — 2027-06-02

Access method: One-Off

Data-controller type: UNIVERSITY OF WARWICK

Sublicensing allowed: No

Datasets:

  1. NDRS Cancer Registrations
  2. NDRS Linked HES APC
  3. NDRS National Radiotherapy Dataset (RTDS)
  4. NDRS Systemic Anti-Cancer Therapy Dataset (SACT)

Objectives:

University of Warwick requires access to NHS England data for the purpose of the following research project: Observational study of Age, test THreshold and frequency on English NAtional Mammography screening outcomes (ATHENA-M).
The following is a summary of the aims of the research project.

1. To understand how age of eligibility, screening interval, and recall threshold for breast cancer screening affect benefits and harms including false positive recalls, overdiagnosis and mortality.

2. To inform revision of the quality assurance guidelines for breast screening centres based on maximising benefit and minimising harm from breast screening.

These aims are being addressed through the following objectives, across three work packages:

Work Package 1: Database development and access
Objective 1: To assemble, clean and assess the quality of the combined datasets
a. To obtain approvals to re-use the observational dataset of 13 million women offered breast screening
b. To clean data and describe data quality

Work Package 2: Causal links between age of eligibility, screening interval, recall threshold and health outcomes
Objective 2: To analyse the causal effect of age of eligibility, screening interval, and recall threshold on intermediate outcomes (numbers of breast cancers detected at screening by cancer type, interval cancers, false positive recalls) and health outcomes (mortality, morbidity, overdiagnosis).

Work Package 3: Pathway to impact
Objective 3: To apply findings to inform changes to practice, including changes to the NHS Breast Screening Programme consolidated standards.

As outlined in the original data request form, University of Warwick require continued access to the dataset that was disseminated previously, with no new data flows. The current data products are:
NDRS Cancer Registrations,
NDRS Systemic Anti-Cancer Therapy Dataset (SACT),
NDRS National Radiotherapy Dataset (RTDS),
NDRS-linked HES Admitted Patient Care,


The level of data currently being held is:
• Pseudonymised

The Data was minimised by the following inclusion criteria (limiting by date range of the appointment and the age of women).
Inclusion criteria:
Women invited to routine population breast cancer screening in England from screening programme inception, where DATEOFFIRSTOFFEREDAPPOINTMENT is 01/01/1988 to 31/03/2018, who:
• Were aged 47 – 73 years at their routine screening invitation; and
• Have at least one demographics record (Table 1), required for linking

The University of Warwick is the research sponsor and the controller and is 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 comes from multiple sources. Current and previous funders include:

• NIHR Career Development Fellowship (the POSTBOx study, CDF-2016-09-018) - funding until 31 October 2022
• NIHR’s Health and Social Care Delivery (HS&DR) Research Programme ATHENA-M project (NIHR130107) funding in place until 31 December 2024
• NIHR Research Professorship (NIHR302434) – funding in place until 30 November 2027

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

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

The University of Birmingham is a processor acting under the instructions of the University of Warwick, with associated collaboration agreement and data processing agreements in place. The University of Birmingham is leading on the test threshold analysis and their involvement is limited to this data analysis.

The University of Bristol is a processor acting under the instructions of the University of Warwick, with associated collaboration agreement and data processing agreements in place. The University of Bristol is leading on the age extension and screening interval analyses and their involvement is limited to this data analysis.


Kings College London are a listed as a co-signatory in the collaboration agreement for this project, due to a co-investigator based at this organisation. They have no access to the data but are acting in an advisory capacity.


The data may be accessed by:
• PhD students affiliated with University of Warwick. Any student working with the Data held under this Data Sharing Agreement (DSA) must have completed relevant data protection and confidentiality training and are subject to the University of Warwick’s policies on data protection and confidentiality. We would also ensure that any student accessing the data would first sign up to the project SLSP (system level security plan), which outlines the security measures that must be adhered to. Any students accessing the Data will do so under the supervision of a substantive employee of the University of Warwick. The University of Warwick would be responsible and liable for any work carried out by students. These students would only work on the data for the purposes described in this DSA.

In developing the funding proposal, a Patient and Public Involvement (PPI) team was established. This PPI team helped refine the purpose of the research and supported the collection of the data for the purposes described above.


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

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

Yielded Benefits:

Analysis of this dataset has been conducted to develop an understanding of how changes in the breast screening programme (age of eligibility, screening interval, number of readers and recall threshold) affect the benefits and harms of breast cancer screening. Examples include: > Initial results have been presented to the Breast screening programme board and a special meeting was requested to discuss these further. > University of Warwick expect the results to impact on breast screening policy, to help ensure that future screening policy decisions are based on the available evidence - by feeding into the process of redrafting the English quality assurance guidelines for breast cancer screening. Update April 29th 2024: Analysis of this dataset is being conducted to develop an understanding of how changes in the breast screening programme (the age of eligibility, screening interval, number of readers and recall threshold) affect the benefits and harms of breast cancer screening. The study team is looking to understand which version of screening offers the most benefit with the least harm, and these findings will be used to advise the UK National Screening Committee and suggest how to change the English quality assurance guidelines for breast cancer screening. The study team has carried out data cleaning and published a paper on the data quality aspects of this dataset and the analyses outlined above are well underway. Results from the analyses on number of readers and age of eligibility will be ready for dissemination in the next couple of months and analysis of screening intervals and reader thresholds will be complete by May. Following this there is a programme of dissemination planned with various research papers, attendance at conferences and policy meetings. This is all on target with revised plans, having had a 12-month no-cost extension approved in 2023. Initial results have been presented to the Breast screening programme board and a special meeting was requested to discuss these further, to be held in spring 2024. The study team expects the results from this research to impact on breast screening policy, to help ensure that future screening policy decisions are based on the available evidence - by feeding into the process of redrafting the English quality assurance guidelines for breast cancer screening.

Expected Benefits:

University of Warwick will use the findings to inform the UK National Screening Committee and revision of the English quality assurance guidelines for breast cancer screening. This will depend on results, but could for example include revising the targets for proportion of women recalled, of DCIS detection rates, or level of flexibility in the screening interval target. The aim is that future screening policy decisions are based on the available evidence.

It is hoped that this research will improve future breast screening design and answer the question of how best to organise screening; such as how often should women be screened, at what age and how many should be recalled for further tests. This should indicate how to best maximise benefits for women and minimise the harms of screening.

It is hoped that through communicating our findings to the UK National Screening Committee and feeding into the process of redrafting the English quality assurance guidelines for breast cancer screening University of Warwick will ensure that future screening policy decisions are based on the evidence arising from the processing of this data.
University of Warwick will explore the implications of the results with their co-applicants and discuss them further at a dissemination event in Autumn 2024, to include their policy and practice advisory group members and further national champions and stakeholders, and this will be the start of their engagement with NHS England to influence English quality assurance guidelines for breast cancer screening.

Bimonthly co-applicant group meetings have helped shape the analysis and have ensured early conversations around how to best disseminate emerging results. This group includes clinicians, policy makers, analysts and patient and public involvement leads.
University of Warwick already have links with various breast cancer charities such as IPCV and Breast Cancer Now and will work closely with them on how they can best share their results.
Finally, the researchers will work closely with the University of Warwick Press Office to advertise the findings to a wider audience should the findings warrant such attention.

Outputs:

The expected outputs of the processing will be:
• Submissions to peer reviewed journals – we have already submitted one paper and anticipate four more papers
• Presentations to key policy makers
• Presentations at appropriate national and international conferences
• A report summarising the findings to the NIHR (as funder of the ATHENA-M project)
Since the data provided is pseudonymized no patient identifiable data is available. In addition, the outputs will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:
• Peer reviewed scientific journals
• Workshops involving key policy colleagues
• Reports to the funder of the research (NIHR)
• Conference presentation and abstracts at national and international conferences
In addition, a series of meetings with policy-makers will be held throughout the project to collaboratively consider how findings may influence policy and the best way to disseminate these findings.

An article in the British Journal of Radiology was published in August 2023 describing development of the ATHENA-M dataset and describing key data quality aspects of the data.
University of Warwick anticipate publishing 4 further journal articles, presenting the main results from the analysis of screening age (anticipated submission date: May 2024), the main results of the analysis on screening interval (anticipated submission date: July 2024) and the main analysis on the analysis on test threshold and the sub analysis on test threshold (focusing on the analysis on number of readers, anticipated submission date: June 2024).
University of Warwick anticipate presenting the work at a number of national and international conferences from the summer 2024 onwards.
University of Warwick plan to hold a dissemination event in summer/Autumn 2024, to include their policy and practice advisory group members and further national champions and stakeholders.

Processing:

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

NHS England provided the relevant records from the above datasets to the University of Warwick previously. University of Warwick require no new data flow out of NHS England.

The Data contains no direct identifying data items. The Data is pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the recipient.

As outlined in the attached SLSP, the University of Warwick securely transferred the data to the University of Bristol and University of Birmingham.


The data is being securely stored on servers at the University of Warwick, the University of Birmingham and the University of Bristol.


The data will not be backed-up at another location.

The encrypted datasets are stored on the ‘M: drive’ which is the Departmental file store used by the University of Warwick Medical School. This file store is accessed via the virtual Windows server LEELA and is stored on the HP 3PAR Storage array. The data, including the server, is mirrored across HP 3PAR storage arrays in both University House data centre and Argent Court data centre for resiliency. Both data centres are on the University of Warwick Campus in Coventry. The data centres, servers, storage, and backup systems are all managed by specialist teams within the central Information and Digital Group (IDG).


The data will be securely downloaded via ODR approved Secure Electronic File Transfer to an already encrypted folder on a University file server (encrypted to AES 256). The server and related data storage equipment is fully managed by the Information & Digital Group and located in a secure data centre. University Data centres have a strictly policed access control system and CCTV surveillance. Occasional visitors/contractors are always escorted by an appropriate member of the Information & Digital Group staff.

The data will only be accessed from University of Warwick managed computers provided by the Information & Digital Group. Desktop computers are secured in offices in the Medical School building on campus. Offices are kept locked whenever unoccupied and the Medical School building also requires University ID card access so only authorised individuals can enter the building. Laptop computers used by study members have full hard disk encryption (AES 256 encryption).

The Data will be accessed by authorised personnel via remote access:

- Remote access will only be from secure locations situated within the territory of use stated within the DSA;
- Access controls granting users the minimum level of access required are in place;
- Remote access is only via VPN to protect data;
- Multifactor authentication (MFA) is required for remote access;
- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;
- All remote access is undertaken within the scope of the project SLSP and complies with the University of Warwick’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).


The Data will not leave the UK at any time.


Access is restricted to employees of the University of Warwick, the University of Birmingham and the University of Bristol and to PhD students enrolled with the University of Warwick. All such individuals will require pre-authorisation from the Principal Investigator.

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

The dataset was linked within Public Health England (PHE) before being shared with the University of Warwick, however the Data will not be linked with any other data outside of this DSA.

All analyses will use the pseudonymised dataset. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset.

All individual data will be combined to develop the models so no individual data will be reported.

Researchers from the University of Warwick will analyse the Data for the purposes described above.
In addition, researchers from the University of Birmingham will analyse the Data for the specific research questions as outlined above (the analysis on test threshold) and researchers from the University of Bristol will analyse the data as outlined above (the analysis on age and screening interval).

Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN (REGAIN) — DARS-NIC-629056-F4L4B

Type of data: information not disclosed for TRE projects

Opt outs honoured: Identifiable (Statutory exemption to flow confidential data without consent)

Legal basis: CV19: Regulation 3 (4) of the Health Service (Control of Patient Information) Regulations 2002

Purposes: No (Academic)

Sensitive: Sensitive

When:DSA runs 2022-03-18 — 2023-03-17

Access method: One-Off

Data-controller type: UNIVERSITY HOSPITALS COVENTRY AND WARWICKSHIRE NHS TRUST, UNIVERSITY OF WARWICK

Sublicensing allowed: No

Datasets:

  1. Demographics

Objectives:

University Hospitals Coventry and Warwickshire NHS Trust (UHCW) and University of Warwick, as joint data controllers, are requesting NHS Digital data under the current COPI Notice that will allow potentially eligible participants to be identified and invited to take part in the REGAIN (Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN) study. The REGAIN study is a UK multi-centre, two-arm, randomised controlled trial funded by the National Institute for Health Research (NIHR) COVID-19 Recovery and Learning Programme (NIHR 132046).

THE AIM OF THE TRIAL
The trial aims to find out if an eight-week programme of online, home based exercise rehabilitation with behavioural, motivational and mental health support is beneficial compared to a single online session of advice and support, in adults with ongoing COVID-19 sequelae (a condition which is the consequence of having Covid-19) more than three months after hospital discharge (long Covid).

It is to be noted that the definition of long Covid used in this trial and agreement is not a universally agreed definition at this present time, but one that has been created for the specific use within this study.

Several hundred thousand people in the UK have been discharged from hospital by the NHS after treatment for COVID-19. Many will return relatively quickly to good health and a normal life. However, a proportion will have ongoing health problems. These problems are multi-systemic including motor, cognitive, neurological, musculoskeletal, respiratory and cardiovascular as well as depression, anxiety, and post-traumatic stress disorder (PTSD). In April 2020, the NHS predicted that 45% of people discharged from hospital would need some ongoing support from health and/or social care. The most recent ONS data indicates that at least 1 in 10 people discharged from hospital will continue to suffer with COVID-19 related problems (Long-Covid) for a period of more than 12 weeks post-discharge. The scale of the pandemic means that many thousands of people in the UK will require long-term multi-disciplinary support and rehabilitation.

There are limited rehabilitation or structured support programmes for COVID-19 survivors with long-extending conditions beyond 12 weeks after hospital discharge. Where programmes exist, their potential benefit/harm is unproven. Research is needed now to find out how best to treat people with Long-Covid. Multi-disciplinary physical and psychological rehabilitation may be beneficial in improving people’s quality of life. However, the size of the problem requires the testing of approaches to multi-disciplinary rehabilitation that can be delivered at scale.

Due to the nature of the Pandemic, this clinical trial was created as an online study, limiting face to face contact. The study team are aware that the online nature of the trial may mean a digitally able population are more likely to join the study than those who do not have access to the online participant facing platform. Where possible, a participant may engage the assistance of a family member or friend with the technical aspects of the study, in which instance the participant would still be able to participate in the trial.

The REGAIN trial is not investigating or tracking any specific Covid-19 variant or investigating Long-Covid (following a hospital stay) resulting from any specific Covid-19 variant, however the study team may as part of this clinical trial, review dates of participant hospitalisation to relate participants to particular Covid waves over the course of the Pandemic.

BACKGROUND TO RECRUITMENT
Since recruitment started in January 2021, the REGAIN study recruited 210 participants of a target 535 participants primarily from secondary care Trusts. The study team has fallen short of the originally intended timeline for completion of recruitment (Aug 2021) due to the significant strains on capacity experienced at all UK NHS Trusts due to the pandemic. Trusts have not had the necessary capacity to undertake the limited screening and mailout work for the study, often declining participation immediately. Recruiting Trusts often paused activity for significant periods of time as they juggled conflicting work pressures. As such, potentially eligible patients are missing out on the opportunity to be invited to the study. This agreement is specifically to support the recruitment to this trial, and aims to recruit to target in 2022 and answer the crucial research question and thus inform long-term care for COVID-19 survivors with Long-Covid following a hospital stay and potentially benefitting patients and society.

STUDY TEAM
Any reference to "the study team" in this agreement refers to members staff employed by University Hospitals Coventry and Warwickshire NHS Trust (UHCW) and University of Warwick directly working on the REGAIN study.

PATIENT AND PUBLIC INVOLVEMENT (PPI)
The study team engaged with an active PPI group, consisting of 6-8 people who had been hospitalised with COVID-19 and had symptoms of long COVID. This PPI group were instrumental in co-creating the REGAIN intervention, attending weekly intervention development meetings. The group extensively piloted live online physical activity sessions, were filmed as participants for on-demand sessions, and tested the online trial outcomes database. The group provided iterative feedback on the participant information leaflet, study flyer, workbooks and outcomes questionnaire. The group includes people with lived experience of long COVID who strongly advocate for rehabilitation. Their recovery trajectory has been slow, and they have received only limited support. They have identified that formal and targeted support is required to help improve the condition and their ability to work and socialise. Their experiences of protracted recovery and diverse symptom profiles have informed the REGAIN intervention and trial design. The study team met regularly with long COVID and chronic fatigue groups to refine the processes and intervention based on lived experience. Lay partners are part of the Trial Management Group (TMG) and Trial Steering Committee (TSG) where they have voting rights in each. TMG and TSG members will be included as co-authors on publications and given the opportunity to engage in trial publicity and dissemination.

LEGAL BASIS FOR COMMON LAW
The UK health and social care system is taking action to manage and mitigate the spread and impact of the Covid-19 pandemic. Action to be taken will require the sharing of confidential patient information amongst health organisations and other appropriate bodies for the purposes of protecting public health, providing healthcare services to the public and monitoring and managing the outbreak. The Secretary of State for Health and Social Care has issued NHS Digital with a Notice under Regulation 3(4) of the Health Service (Control of Patient Information) Regulations 2002 (COPI) to require NHS Digital to share confidential patient information with organisations entitled to process this under COPI for COVID-19 purposes.

The purpose of the COPI Notice (expires on 30 June 2022) is to provide NHS Digital with the necessary statutory power to disseminate confidential patient information to organisations permitted to process confidential patient information under Regulation 3(3) of COPI for the purposes set out in Regulation 3(1) of COPI to support the Secretary of State’s response to Covid-19 (Covid-19 Purpose). This Notice is necessary so that NHS Digital can lawfully and efficiently disseminate confidential patient information to those organisations set out in Regulation 3(3) of COPI being persons employed or engaged for the purposes of the health service or other persons employed or engaged by a Government Department or other public authority in communicable disease surveillance in connection with the health and social care system’s management of the response to Covid-19.

The study team envisage the recruitment to have completed by 30/06/2022 and therefore no alternative legal basis is being pursued post expiry of COPI.

The aim of this application is to request, under the COPI Notice, information from NHS Digital that will allow potentially eligible people to be identified and invited to take part in the REGAIN study. This information will be used by NHS DigiTrials' sub-processor, APS Group, to send postal invites to around 20,000 potential participants, over two mailings with the aim to recruit a further 325 participants to the trial. Following the mail-outs, should the study team fail to meet the recruitment target a further mailout(s) may be undertaken until the recruitment target is met within the COPI notice period (to expire on 30 June 2022). The information will not be shared with the University of Warwick or University Hospitals Coventry and Warwickshire NHS Trust who act as joint data controllers for the study. After receipt of the postal invitation, interested people will contact the study team at University of Warwick directly via the study website suitability checker and provide contact details allowing the team to contact them by telephone to conform eligibility. This will be the first time the REGAIN team views any confidential information.

GDPR LEGAL BASIS FOR PROCESSING
Both University Hospitals Coventry and Warwickshire NHS Trust and University of Warwick rely on GDPR Article 6(1)(e) of the General Data Protection Regulation (GDPR) to process personal data where processing is necessary for a task carried out in the public interest. In this instance the public interest task is research. The data are required for research purposes in the public interest- meeting the conditions in the DPA 2018 Schedule 1 Part 1 (4) - which GDPR Recital 52(2) determines is an appropriate derogation from the prohibition on processing special categories of personal data. The ways in which the processing of data will be of benefit to the public – thereby demonstrating that the processing is in the public interest – are described in section ‘5d. ii. Expected Measurable Benefits to Health and/or Social Care Including Target Date’.

- In accordance with GDPR Article 89(1) processing is subject to appropriate safeguards. These include:
i. The data recipient’s technical and organisational measures to safeguard the data have been assessed and meet NHS Digital’s acceptance criteria (see sections 2 and 5b of this application for further details) although it should be noted that neither University of Warwick and University Hospitals Coventry and Warwickshire NHS Trust will be receiving data from NHS Digital in this agreement;
ii. The requested data has been assessed as proportionate to the aim pursued (see section 5a of this application for further details);
iii. Controls, data retention and processing activities have been assessed to ensure respect to the essence of the right to data protection;
iv. Measures to protect the rights and freedoms of data subjects have been assessed including transparency (fair processing) publishing subject’s rights.

Both Controllers also rely on Article 9(2)(j) of the GDPR to process special category data (in this case health data) where processing is necessary for scientific research purposes. This study will use scientific research in order to identify rehabilitation solutions for people with Long-Covid following a hospital stay. The data minimisation process is being followed and only data that is required specifically for the purposes of this study has been requested, to protect the rights of the data subjects.

INCLUSION AND EXCLUSION CRITERIA
The trial will be conducted throughout the UK and the aim is to recruit a further 325 participants.

Inclusion criteria:
• 18 years or older,*
• Treated in hospital with COVID-19,
• Discharged from hospital at least 3 months ago,
• Alive

Exclusion criteria:
• Potential participants from NHS Trusts in England that have already undertaken REGAIN invitation mailouts as Primary Identification Centre sites (PIC sites). This will ensure the likelihood of contacting patients who have already been invited is minimal and therefore reduces patient burden.

* Children (17 years or younger) have not been included in this clinical trial as the logic model applied to the development of this intervention for Long-Covid has been based on a previously developed adult intervention which was not designed for use by children.

ORGANISATION’S ROLES AND RESPONSIBILITIES:

UHCW and University of Warwick are the applicant and joint data controllers. They are responsible for the trial and overseeing the work carried out to aid recruitment into the trial. They are also responsible for providing the core eligibility criteria for participants.

UHCW and University of Warwick are joint data controllers and are responsible for:
1. Generating the invitation request(s) and sending to NHS Digital.
2. Monitoring uptake by invitees (i.e. numbers of invitees consenting to participate in the trial)
4. Monitoring scope of the population booking appointments and entering the study

NHS Digital are acting as a data processor on behalf of UHCW and University of Warwick and are responsible for:
1. Applying the inclusion and exclusion criteria from the invitation request to the datasets to generate a list of invitees
2. Feeding back to UHCW and University of Warwick the number of invitees actually fulfilled out of the total target population (if less than 20,000 target)
3. Removing objections or opt outs
4. Sending the list of invitees on to their third-party provider (Allied Publicity Services (APS) Group) for generating the invitation letters and mailing these out
5. Agreeing with UHCW and University of Warwick key processing timelines, including
a. Time from submission to APS Group to mailout
b. Date of the mail outs
6. Overseeing performance of APS Group and alerting performance issue to UHCW and University of Warwick.
7. Feeding back to UHCW and University of Warwick performance in relation to KPIs of APS and NHS Digital
8. Where the number of invitees is less than the population available, invoking a system to choose invitees at random
9. Maintaining a record of people invited and ensuring they are excluded from second rounds of invitations.

Allied Publicity Service (APS) are acting as a sub-processor of NHS Digital. Their responsibility is to receive the lists of invitees from NHS Digital and mail out to them accordingly.

The Trial Management Group (TMG) and Trial Steering Committee (TSG) - Both groups contain members of the study team and other external collaborators from other academic institutions who are likely leads in the field of respiratory health or clinical trials. The groups are responsible for monitoring all aspects of the conduct and progress of the study, to ensure that the protocol is adhered to and to take appropriate actions to safeguard participants and the quality of the study itself. These members do not making decisions on the design of the study and the purpose and means of processing the data and are therefore not considered Data Controllers. External collaborators have no access to NHS Digital data and are therefore not considered Data Processors either.

The National Institute for Health Research (NIHR) funds this clinical trial but does not make any decisions determining the purposes and means of the processing, nor the way the study is conducted and is therefore not considered a Data Controller.

While UHCW and University of Warwick are joint data controllers for this trial, neither will have access to the patient-level identifiable data provided by NHS Digital to APS Group.

Expected Benefits:

There is a need to deliver the REGAIN study rapidly to inform care for COVID-19 survivors with Long-Covid after a hospital stay and to achieve the greatest benefit for patients and society.

Use of data from NHS Digital for a REGAIN invitation mailout aims to ensure 20,000 patient invites are sent out over the duration of one month which is much higher than current rate of recruitment. To date NHS Trusts have sent out an estimated 8000 invites over 13 months. The use of data from NHS Digital should allow for more timely recruitment into the REGAIN study and remove the significant capacity constraints suffered by NHS Trusts which have impaired recruitment to date and would have seen recruitment end in 2024.

The aim of this agreement is to allow the study to reach its recruitment target within 2022, answer important research questions, and disseminate results with maximum impact at a time where the answer is still relevant and sought after. The study team anticipate that the impact of this study will be sufficient to influence rehabilitation policy for people with Long-Covid.

Completion of the study benefits healthcare provision by addressing the rehabilitation challenge the UK is now facing as a result of the large number of people with Long-Covid (after a hospital stay) over a short time frame. This has physical, psychological and economic consequences at individual and societal levels. While acute interventional research has rapidly developed, the REGAIN intervention has the potential to guide recovery and re-entry to economic productivity for those living with the longer-term consequences of COVID-19. It should again be noted that due to the specific exclusion and inclusion criteria of this study, the expected benefits of the study are therefore focused on those hospitalised with Long-Covid.

Long-term rehabilitation interventions are not routinely offered to people with Long-Covid. The study team are under the understanding that there are no rehabilitation interventions currently being tested in the UK for people who have not fully recovered from COVID-19 more than three months after hospital discharge. This group are likely to require intensive support as they are at high risk of chronic physical and mental health problems.

If either of the interventions tested in this trial are found to be effective, the study team will have an intervention suitable for immediate implementation nationally and internationally. Implementation of a successful programme has the potential to substantially reduce the chronic burden of COVID-19 in a large number of survivors, who, in the current unique pandemic environment, may not have access to normal social and primary/community care support. Apart from the direct benefits for those concerned, improving the general health of survivors has the potential to reduce demand on health and social services more widely and improve economic productivity.

The immediate benefit of using information from NHS Digital for a REGAIN mailout will be comprehensively and accurately measured by the number of patients expressing an interest via the study website after receiving the postal invitation. The study team intend to observe trial uptake during the time when mailout work will be undertaken, in line with the end of the current COPI Notice (30 June 2022). The REGAIN team are suitably equipped and staffed to manage the predicted upturn in participants following a mailout using NHS Digital.

Outputs:

As a result of this recruitment agreement with NHS DigiTrials, the REGAIN study team are hoping to recruit to target having posted out adequate numbers of invitations to potentially eligible participants. The completion of this trial in a timely fashion would be in jeopardy without the adoption of this recruitment approach and the use of data in this way is now critical to the success of the trial.

Results for this trial are time sensitive and should the trial continue to recruit at its previous rate, results will be less relevant in a post-pandemic environment. Timely completion of the trial is in the interests of both NHS providers and people with Long-Covid after a hospital stay, and the study team will aim to report on both clinical and cost-effectiveness.

The results of the REGAIN study have the potential to influence rehabilitation practices UK wide, therefore, the study team aim to submit trial results for publication and dissemination as quickly as possible. All outputs and publications will contain only aggregated data.

Identifiable health data requested from NHS Digital will only be used to identify and invite potential participants. NHS Digital record Level Identifiable data will not be reported, and participants will be anonymised in all outputs and publications.

This is an NIHR funded study, and all outputs of the trial will therefore be reported to the NIHR. It is anticipated that the NIHR will publish a report of the REGAIN study on its website. The trial will be reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines.

Specific anticipated outputs include:
• The final NIHR Health Technology Assessment (HTA) Mongraph; due to be published in 2023.
• Peer reviewed publications submitted mid-late 2022 and published early 2023.
• Main trial findings summarised on the Warwick Clinical Trials Unit main website.
• Findings to be disseminated via social media, including the Warwick Clinical Trials Twitter page (@WarwickCTU) and the REGAIN study Twitter page (@RegainStudy)

The study findings hope to be widely promoted on Twitter and usual scientific routes, thus via national and international academic conferences and peer-reviewed publications. There are patient representatives within the research team who it is expected will also be involved with preparing materials for wider dissemination. Findings should feedback to patient groups who provided input to the early development phases of the trial.

The University of Warwick are planning to work with their Marketing and Communication team to develop a strategy for communication with the media (television, radio, newspaper etc) to enhance communication of the trial results to patients / participants.

The University of Warwick also intend to produce a lay summary of the trial results with their public and patient involvement partners that include the trials management group (monthly meeting) and the independent trial steering committee that meets on a bi-annual basis. All groups have lay representation and participants from variety of backgrounds. This is anticipated to be disseminated to participants of the trial who indicated they wanted to know the results.

Due to the specific exclusion and inclusion criteria of this study, it should be noted that the outputs of the study are based on those hospitalised with Long-Covid, and will not include any participants who may meet other diagnostic criteria for Long-Covid but were not hospitalised.

Processing:

As joint data controller, UHCW and University of Warwick will provide the core eligibility criteria for those potential participants who will receive invitations. UHCW and University of Warwick, refine the population that receive these invitations based on NHS Trusts (as a proxy for location), making adjustments as required to ensure adequate representation of target populations. NHS Digital would be using an established contract with a mailing provider (APS Group) to fulfil the communications. The APS Group are also used by NHS England and NHS Improvement as a marketing service group that is a recognised and trusted provider of NHS Services. They are used frequently to co-ordinate mail outs for NHS Bodies. APS Group will use REC-approved template invitation letters and would add address details onto the letters prior to mailing it out. All identifiable data provided to APS Group by NHS Digital will be done so under the legal basis of COPI Regulations.

Data processing is carried out by substantive employees of NHS Digital who have been appropriately trained in data protection and confidentiality. NHS Digital will access records allowing them to gather the following information needed to determine suitability for invitation to the REGAIN study.

COHORT IDENTIFICATION:
• Using the inclusion and exclusion criteria as specified by UHCW and University of Warwick, NHS Digital will interrogate the Patient Demographics Service (PDS) dataset and extract all those potential participants who meet the criteria within the latest specification as provided by UHCW and University of Warwick.
• Of the potential participants, for the first 2 mailouts, 20,000 records (approximately 10,000 per mail out) will have their relevant contact details (Forename, Surname, Address, Postcode,) extracted ready for despatch to APS Group. (Should any further mailouts be required, the number of records required will be ascertained based on the current uptake percentage and the number of participants yet to be recruited to the trial at that time. No potential participant will be contacted more than once for this trial)
• NHS Digital will then remove any records where a national Data opt-out has been registered, as well as special categories of people for whom the data should not be disseminated. The purpose of the restriction is to ensure that patient information that might imply a location is protected.
• NHS Digital will also provide APS Group with a generic Screening ID to include within the mailing (in the format NHS0001). This screening ID will allow UHCW and University of Warwick study team to know that the patient received a postal invite following the mailout from NHS Digital. UHCW and University of Warwick would not be able to use this screening ID to identify any individual member of the cohort.

COHORT DISSEMINATION AND MAILOUT:
• NHS Digital will create an extract of potential participant records which will be added to a mailing list cohort dataset (approximately 10,000 per mail out for the initial 2 mailings. Extract number to be determined should any future mailing be required to meet recruitment target)
• NHS Digital will provide APS Group with Forename, Surname, Address, Postcode, and screening ID via Secure Electronic File Transfer (SEFT.)
• APS will then mail out to individuals as required.
• All potential participants will receive an invitation letter containing their Name, Address and Postcode, and Screening ID. The screening ID provided on the postal invitation letter for all patients may be entered by interested patients on the REGAIN study website when registering their interest in the study. This screening ID will allow the REGAIN team to know that the patient received a postal invite following the mailout (as opposed to a PIC site mailout).
• APS will destroy all data received from NHS Digital one week after mailing as instructed by NHS Digital.

No patient data will flow from University of Warwick and UHCW to NHS Digital and vice versa.

Patients will receive one postal invitation; there will be no attempts to remind or re-approach patients who do not respond to the postal invitation. In the unlikely event an invitation letter is sent to a person who has not had COVID-19, the invitation letter/flyer will explicitly state that they should ignore/destroy the letter/flyer.

The data from NHS Digital will not be used for any other purpose other than that outlined in this Agreement. The data from NHS Digital will not be linked to any other data other than those outlined in this Agreement.

MR1132 - OPERA - Older People's Exercise in Residential and nursing Homes — DARS-NIC-372677-H7S0S

Type of data: information not disclosed for TRE projects

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

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

Purposes: No (Academic)

Sensitive: Sensitive

When:DSA runs 2017-03-05 — 2020-03-31

Access method: One-Off

Data-controller type: UNIVERSITY OF WARWICK

Sublicensing allowed: No

Datasets:

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

Objectives:

Medical Research Reports (MRIS) data was supplied to University of Warwick by the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to as "MR1132 - OPERA - Older People's Exercise in Residential and nursing Homes." Flagging Current Status Reports and Cause of Death Reports were disseminated covering the period up until May 2011.

This Data Sharing Agreement permits the retention of the data for an interim period but no other processing of the data is permitted.

Permission to retain the data for the interim period is a practical step to enable the study to comply with the necessary legal and ethical requirements. If, for any reason, it is not possible for the study to meet the necessary requirements, this Agreement will be terminated, and destruction of the data will be required.

The following information provides background information on the purpose of the original study. No new data will be released under this version of the agreement, and this agreement allows the applicant to hold and not otherwise process any further data that has already been disseminated.

Background

This study aims to explore the impact of a 'whole-home' intervention to promote exercise and
social interaction on the amount and severity of depression among people living in residential and nursing homes.

In addition to measuring levels of depression, the study will also collect data on health related
quality of life, cognitive function, mobility, chronic pain, incidence of injurious falls, hospital
admissions, prescribing costs and mortality. 80 residential and nursing homes (RNHs) across East London and the Midlands will take part. University of Warwick will compare the effects of implementing a depression awareness programme whereby staff will be trained to identify depressed residents, with the effect of a physical activation and exercise programme.

Yielded Benefits:

In any future application, the applicant will be required to provide details of the actual benefits achieved as a result of the study. Minor detail has been added here as follows: Final NIHR HTA report Lancet publication and other related publications

Expected Benefits:

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

MRIS data was supplied to University of Warwick by the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to as "MR1132 - OPERA - Older People's Exercise in Residential and nursing Homes."

This Data Sharing Agreement permits the retention of the data for an interim period but no other processing of the data is permitted.

Permission to retain the data for the interim period is a practical step to enable the study to comply with the necessary legal and ethical requirements.

If, for any reason, it is not possible for the study to meet the necessary requirements, this Agreement will be terminated, and destruction of the data will be required.

Outputs:

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

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

This Data Sharing Agreement permits the retention of the data for an interim period but no other processing of the data is permitted.

No further outputs of the data are permitted to be created under this version of the agreement.

Processing:

Medical Research Reports (MRIS) data was supplied to University of Warwick by the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to as "MR1132 - OPERA - Older People's Exercise in Residential and nursing Homes." Flagging Current Status Reports and Cause of Death Reports were disseminated covering the period up until May 2011.

This Data Sharing Agreement permits the retention of the data for an interim period but no other processing of the data is permitted.

Permission to retain the data for the interim period is a practical step to enable the study to comply with the necessary legal and ethical requirements. If, for any reason, it is not possible for the study to meet the necessary requirements, this Agreement will be terminated, and destruction of the data will be required.

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).

No new or further data will be provided under this version of the agreement. A short term extension is in place as a pragmatic approach to enable legal retention of already disseminated data. This agreement allows retention of data, but not permission to otherwise process it.

ADAPT-Sepsis Trial. BiomArker-guided Duration of Antibiotic treatment in hospitalised PaTients with suspected Sepsis — DARS-NIC-706399-T8V0C

Type of data: information not disclosed for TRE projects

Opt outs honoured: Identifiable, Yes, No (Consent (Reasonable Expectation))

Legal basis: Health and Social Care Act 2012 - s261(5)(d); Health and Social Care Act 2012 – s261(2)(c)

Purposes: No (Academic)

Sensitive: Sensitive

When:DSA runs 2024-04-01 — 2027-03-31 2024.09 — 2024.09.

Access method: One-Off

Data-controller type: THE UNIVERSITY OF MANCHESTER

Sublicensing allowed: No

Datasets:

  1. Civil Registrations of Death

Objectives:

The University of Manchester requires access to NHS England Data for the purpose of the following research project: BiomArker-guided Duration of Antibiotic treatment in hospitalised PaTients with suspected Sepsis: the ADAPT-Sepsis Trial.

The following is a summary of the aims of the research project provided on behalf of the University of Manchester:
A Multicentre three-arm randomised controlled trial with internal pilot, to deliver a UK-wide multi-centre randomised controlled trial to determine whether treatment protocols based on monitoring daily CRP (C-reactive protein) or PCT (procalcitonin) safely allow a reduction in duration of antibiotic therapy in hospitalised adult patients with suspected sepsis.

Sepsis is a condition that results from potentially serious infections. If a patient has sepsis, their body’s defence mechanisms (or ‘immune system’) may react excessively and fail. It is known that treatment using antibiotics, started as early as possible, is essential. While starting antibiotics to combat sepsis is crucial it is less clear when this treatment can safely stop. The lack of research on when to stop treatment safely may be leading to an overuse of antibiotics. Antibiotic overuse is becoming a problem because it promotes bacteria that are resistant to antibiotics (so-called antimicrobial resistance), which means that sepsis and, indeed, other infections would become difficult to treat in the future. Shorter courses of antibiotics for a patient with sepsis, may result in reducing the risk of antibiotic resistance, with fewer side effects (all medicines including antibiotics may cause side effects in some patients) and reduced costs.

Chemicals circulating in the blood can indicate the level of an infection and how effective the treatment of an infection is. These chemicals are called biomarkers. The two most well researched biomarkers in sepsis are ‘C-reactive protein’ (CRP) and ‘procalcitonin’ (PCT). They are both chemicals produced by the human body in response to infection and they can be easily measured in blood samples using NHS laboratory equipment. A number of studies around the world have shown that high levels of both CRP and PCT in the blood of patients with sepsis fall when antibiotics are given and the infection is reduced. The ADAPT-Sepsis trial hopes to determine if the duration of antibiotic treatment given to patients with sepsis can be safely reduced if these biomarkers are closely monitored every day.

The ADAPT-Sepsis trial will focus on hospitalised adults who have been commenced on intravenous antibiotics for sepsis. The inclusion criteria is:
(a) At least 18 years old;
(b) receiving intravenous antibiotics for sepsis;
(c) no more than 24 hours of systemic antibiotic treatment for present sepsis episode;
(d) likely to require intravenous antibiotics for at least 72 hours and
(e) requirement for critical care.

Main exclusions are:
(a) prolonged antimicrobial therapy mandated;
(b) severely immunocompromised;
(c) All treatment for suspected sepsis likely to be stopped within 24 hours of its initiation because of futility
(d) any patient given, or anticipated to receive an IL-6 receptor inhibitor drug (e.g. tocilizumab or sarilumab) during their acute hospital admission.

Outcomes will be assessed to 28 and 90 days. The primary outcomes are total duration of antibiotics and safety outcome of all-cause mortality. Secondary outcomes include: escalation of care/re-admission; infection re-lapse/recurrence; dose of antibiotics; length and level of critical care stay and length of hospital stay. 90-day all-cause mortality rates will also be collected.

Patients are expected to have been transferred and/or discharged up until the 28-day and 90-day data collection points. Informed consent has been obtained from the patient via signing the consent forms or via Personal Consultee Advice (as described below) for these data collection points (if not withdrawn before this point).

However, in many cases it is not possible to obtain prospective consent from the patient at the time of enrolment. This is due to the fact that many patients have a reduced level of consciousness due to their illness or due to sedative medications used as part of their treatment. If the patient is unable to give consent, advice will be sought from the patient’s Personal Consultee, who may be a relative, partner or close friend. This is in line with the legal requirements for obtaining consent in patients without capacity in England and Wales (Mental Capacity Act 2005). Patients, for whom an opinion is given by a Consultee, will be monitored and if they gain capacity by the time of primary hospital discharge, or by 28 days from randomisation, (whichever is earliest) they will be informed of their participation in the trial by the responsible clinician or a member of the research team and asked to provide their direct consent. If the patient does not want to continue follow-up in the study no further clinical data beyond that time-point or new samples will be collected.

The Trial team have worked with the Intensive Care Society’s Patients and Relative Committee (ICSPRC) which includes the ICU Support Teams for Ex-Patients (ICUSteps). These groups include patients and relatives who have experienced sepsis and acute hospital care, providing crucial insights for the proposed study and its acceptability for patients. Specific work includes developing a study protocol to offer participation to a wide range of hospitalised adults with sepsis across the UK; developing the Public and Patient Involvement (PPI) study plan; help with developing connectivity with relevant government advisory groups (notably the Advisory Committee on Antimicrobial Resistance & HAI). Additionally, there is public representation on the Trial Steering Committee (TSC). To ensure broader engagement, a PPI collaboration has been formed, with links to the Trial Management Group (TMG). This is a two-way process, to ensure the research team benefit from understanding public perception on sepsis and outputs are communicated effectively to the public.

Patients will be randomised to one of two intervention groups (CRP or PCT guided antibiotic duration) or a standard care (control) group. The cohort of patients in this trial will be cumulative over time as recruitment is ongoing, made up of approximately 3,000 individuals. Recruitment started in January 2018 and hopes to be completed by the end of July 2024. The trial will end when all participants have completed 90-day follow-up and the trial database is locked.

The following NHS England Data will be accessed:
Civil Registrations of Deaths will be accessed for the purpose of obtaining 90-day all-cause mortality rates and data minimisation of fields selected has been applied to ensure the only data required for the above purpose has been requested.
Historic data back to February 2018 will be required to approximately October 2024 to cover the 90 day follow-up of all participants in the trial.

The University of Manchester is the research sponsor and the Controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above. The University of Manchester will have no access to record-level NHS England data.

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

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

This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.

The funding is provided by the National Institute for Health Research (NIHR)’s Health Technology Programme. The funding is specifically for the ADAPT-Sepsis trial described. Funding is in place until July 2024. The funder will have no ability to suppress or otherwise limit the publication of findings.

The University of Warwick is a Processor acting under the instructions of the Controller. The University of Warwick's role is limited to the outcomes analysis of the trial.

An assessment of in-trial cost effectiveness will be performed by the University of Sheffield in a Health Economic Evaluation, which would include key outcomes such as: rates of mortality; costs associated with length of stay for the index hospitalisation, including escalation of care; costs associated with readmission; and costs associated with antibiotic use. However, it should be noted that the University of Sheffield will undertake this analysis on ADAPT-Sepsis study data and will not access record-level NHS England Data as described in this Data Sharing Agreement (DSA). Therefore, the University of Sheffield is not considered a Processor in this DSA.

Expected Benefits:

The results of this study would have significant impact in three main ways:
A. Patient benefit: if the trial finds that CRP or PCT-guided protocols reduce patient exposure to antibiotics, maintain patient safety and are cost-effective it would have a major impact on the way health care providers currently manage the large number of patients with sepsis in the NHS. It would also help protect the effectiveness of currently available antibiotics for the whole population and, similarly, would help develop care standards to protect future antibiotics as they are developed.

B. Change in practice: if effective it would lead to consensus on the preferred standard of care for patients with sepsis and prompt changes to NICE guidance, with resultant change to care pathways and resource use across the NHS. However, importantly if there was no benefit, the trial would provide evidence to stop the widespread use/adoption of CRP and PCT tests for monitoring sepsis care that would be expensive and ineffective or potentially harmful to patients.

C. Future trials: demonstrating clinical and cost -effectiveness alongside safety would support extending investigations of biomarker-guided antibiotic discontinuation to other populations, most notably hospitalised children and neonates with suspects sepsis.

Outputs:

In accordance with NIHR open access policies the trial hopes to publish the clinical findings of the trial as well as a paper describing the cost-effectiveness in the NHS setting in high quality peer-reviewed open access (via PubMed) journals. A final report hopes to also be published in the NIHR HTA journal.

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.

NICE issued guidelines for PCT monitoring of sepsis in 2015 and encouraged clinicians to enter patients into future NHS trials aimed at testing biomarker-guided antibiotic discontinuation for sepsis. The trial team have planned their trial to address NICE’s recommendations so that subsequent results hope to inform their future guidance on sepsis. The Trial team aims to inform NHS managers and commissioners if the study supports a change of practice.

A lay person’s summary, led by the PPI study group, aims to be distributed to local and national patient support and liaison groups including the Critical Care Patients and Relatives Committee and the Intensive Care Unit Support Teams for Ex-Patients. Following peer reviewed publication, appropriate key findings hope to be communicated through press releases led by the NIHR in partnership with the trial host institutions to ensure dissemination to the broader public and research participants .

Processing:

There will be 3 cumulative cohort uploads and 3 data drops during the lifetime of this Data Sharing Agreement, following the below method:

1. The University of Warwick will extract NHS Number, Date of Birth and Date of Consent for the cohort of study participants, and then apply a pseudonymisation ID (the study ID). The University of Warwick will split the cohort into two files; One file will have directly consented individuals; one file will have individuals recruited under consultee advice. The two files will be sent securely to NHS England via NHS England’s Secure Electronic File Transfer service (SEFT).

2. NHS England will link the two cohorts to the Civil Registration of Death dataset and extract the required data fields for the 90 day period from the Date of Consent. NHS England will apply National Data Opt-Out to the cohort of individuals who were recruited to the trial under consultee consent.

3. NHS England will then return the requested record-level Data files back to University of Warwick via SEFT. a secure electronic file transfer.

The Data will be stored on servers at the University of Warwick only.

Authorised members of the ADAPT-Sepsis Trial will process the Data for the outcomes purposes described above. Access is restricted to employees or agents of the University of Warwick and are appropriately trained in data protection and confidentiality.

The trial team will link the Civil Registration of Death dataset to an existing research dataset. This database has been pseudonymised by removing all patient identifiers, leaving only the pseudonymised study ID. The identifying details will be stored in a separate database to the linked dataset used for analysis. All outcomes analyses will use the pseudonymised dataset. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset.

The Data will be accessed by authorised personnel via remote access. The Data will remain on the servers at the University of Warwick at all times.

The Controller must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.

For remote access:
- Remote access will only be from secure locations situated within the territory of use stated within this DSA;
- Access controls granting users the minimum level of access required are in place;
- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;
- Multifactor authentication (MFA) is required for remote access;
- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;
- All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this agreement) and complies with the organisation’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).

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

Mammo-50: Mammographic surveillance in breast cancer patients aged 50 years or older — DARS-NIC-658720-R3V5Z

Type of data: information not disclosed for TRE projects

Opt outs honoured: Identifiable, No (Consent (Reasonable Expectation))

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

Purposes: No (Academic)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2023-07-18 — 2026-07-17 2023.10 — 2024.08.

Access method: One-Off

Data-controller type: UNIVERSITY OF WARWICK

Sublicensing allowed: No

Datasets:

  1. Cancer Registration Data
  2. Civil Registrations of Death
  3. Hospital Episode Statistics Admitted Patient Care (HES APC)
  4. Hospital Episode Statistics Critical Care (HES Critical Care)
  5. Hospital Episode Statistics Outpatients (HES OP)

Objectives:

The University of Warwick, require access to NHS England data for the purpose of the following research project: Mammo-50: Mammographic surveillance in breast cancer patients aged 50 years or older.

The Mammo-50 study is a multi-centre, phase III, randomised controlled trial (RCT) of annual mammography versus 2 yearly for conservation surgery patients and 3 yearly for mastectomy patients. There is also an observational cohort study offered to those patients for whom the specialist or patient opts for standard mammography per local practice or immediate discharge to the screening programme or stopping mammography altogether.

The following is a summary of the aims of the research project provided by the University of Warwick.

The aim of the Mammo-50 study is to investigate the most effective and safest way of monitoring women of 50 years or over at diagnosis, who have been treated surgically with curative intent for invasive and
non-invasive breast cancer, and are more than 3 years post-surgery. It will also consider acceptability to patients and cost-effectiveness. It may eventually inform national guidelines about the best way to follow up women who have had surgery for breast cancer. The observational cohort study will compare demographics and outcomes between these non-randomised participants and those that were randomised into the trial to inform the generalisability of the results of the RCT.

DATA REQUESTED:
The following NHS England data will be accessed:

• Hospital Episode Statistics Admitted Patient Care, Critical Care and Outpatients: necessary to determine if there is a difference in survival, required hospital-based health care activity, and associated cost to the NHS between the trial arms, and in comparison, to the observational cohort.

• Civil Registrations Deaths and Cancer Registration data: necessary to determine if there is a difference in disease specific survival, recurrence of disease, and survival between the different treatment groups, and in comparison, to the observational cohort. Mortality data will be used to verify the data reported by participating NHS hospitals. For example, the University of Warwick will check whether there are any additional deaths identified in the Civil Registration Deaths data that have not already been reported via the Case Report Form, or where the date and/or cause of death is discrepant to that reported by the NHS hospital. Where there are additional or discrepant deaths identified, the University of Warwick trial team will ask the relevant NHS hospital to review the status of these participants and provide any new or corrected data to make the main trial dataset as complete as possible. No NHS England Data will be shared with the NHS hospitals during this process.

The level of data will be identifiable, which is necessary to enable linkage of the data with data collected from other sources and completion of the analysis, including data direct from the participants and the recruiting NHS hospital

DATA MINIMISATION:
The data will be minimised as follows:

Limited to a study cohort identified by the University of Warwick for the cohort of patients who are consented to participate in the Mammo-50 trial or the observational cohort study. The cohort of patients are all female, aged 50 or over at initial diagnosis, had excised invasive or non-invasive (DCIS) breast cancer with local treatment completed, had 3 years post curative surgery and showed no evidence of local recurrence or new breast cancer primary distant metastases or any new malignancies. Limited to data between 2014/15 to 2022/23. For each individual patient, HES data will only be provided from the date they consented to join the trial.

DATA CONTROLLERSHIP:
The University of Warwick and University Hospitals Coventry and Warwickshire (UHCW) are Co-Sponsors for the MAMMO-50 study. The University of Warwick is the sole data controller as the organisation responsible for ensuring that the data will only be processed for the purpose described above.

Although UHCW is a co-sponsor, UHCW will not carry out any data controllership or processing activities.

GDPR LEGAL BASIS:
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 and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.

FUNDING:
The funding is provided by the National Institute for Health and Care Research (NIHR). The funding is specifically for the MAMMO-50 study described. Funding is in place until December 2023. The funder will have no ability to suppress or otherwise limit the publication of findings.

ORGANISATIONS INVOLVED IN AN ADVISORY CAPACITY
There are multiple clinical collaborators on the trial who have been involved with the management of the trial. This included advising on the data items the study should collect from the NHS sites who recruit and follow-up the cohort, at the beginning of the trial. They will not be involved, nor will they advise on the data processing, but they are likely to help interpret the aggregated results (with small numbers supressed) for the purposes of the report.

The trial has three oversight groups: the Trial Management Group (TMG), the independent Trial Steering Committee (TSC) and the independent Data Monitoring and Ethics Committee (DMEC).

The TMG includes a multidisciplinary team of clinicians, statisticians, translational scientist and a patient advocate who all have considerable expertise in all aspects of design, running, quality assurance and analysis of the trial. This group includes co-investigators as well as experts co-opted for their expertise. Only members of the TMG who are analysing the data for the purposes outlined above will have access to the data.

The TSC provides advice, through its chair, to the chief investigator, the trial sponsor, the trial funder, on all appropriate aspects of the trial. The DMEC provides advice to the TSC.

DATA ACCESS:
Data will be accessed by the team at the University of Warwick and by two individuals from the University of Leeds who hold honorary contracts with the University of Warwick.

PATIENT AND PUBLIC INVOLVEMENT:
A Public and Patient Information and Engagement group was consulted regarding the collection of the data for the purposes described above. The Independent Cancer Patients Voice (ICPV) was consulted, via an individual member of the group. The frequency of meetings varied from monthly to every 6 months.

Additionally, an individual patient representative for the Mammo-50 study, and user representatives of the National Cancer Research Institute (NCRI) breast cancer clinical study group, have been influential in defining the acceptability of the current trial design, alongside the ICPV. Patient representatives will be involved in the dissemination of study results.

Outputs:

The trial aims to show whether continued annual surveillance mammography is needed 3 years post curative surgery, by which time most women have been discharged from hospital follow-up. There is very little data to support continued annual surveillance mammography and this trial will fill the evidence gap. There is also a huge disparity in follow-up protocols adopted nationally and Mammo-50 aims to provide information as to the type of follow-up adopted at each hospital and acceptability to patients. The results of the trial are likely to be of interest globally to a clinical audience, policy makers, patients and the general public. Dissemination of trial results will be widespread and will inform clinical practice whatever the outcome.

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

The expected outputs of the processing will be:

- Journals: including the New England Journal for Medicine and the Lancet Oncology

- National and International Cancer Conferences

- NICE Guidelines - specifically NG101: Early and locally advanced breast cancer: diagnosis and management

- Social media platforms (Including Twitter).

- Patient Information leaflets will be prepared and made available at each study recruitment site, which shall feedback results to patients.

- Public promotion of the research: Cancer Research UK (CRUK) and BCN (Breast Cancer Now), and Independent Cancer Patients' Voice (ICPV) are aware of the study and lay summaries will be made available on, for example, relevant websites.

In line with funding requirements, a report will be submitted to the NIHR summarising the trial results, including the cost-effectiveness analyses. The deadline for submitting the final report is 31st December 2023; the report will be published in the NIHR Journals Library.

The aim will be to present the findings of the report at the San Antonio Breast Cancer Symposium (SABCS). The study will also aim to share their findings with the New England Journal for Medicine, Health Economics Paper and the Lancet Oncology. It is hoped outputs will be available late 2023 / 2024.

The intention is for outputs to be published with open access.

Processing:

The University of Warwick will transfer data to NHS England. The data will consist of identifying details, specifically, NHS Number, Date of Birth, and a unique person ID. Date of consent for each participant will be provided by the University of Warwick.

NHS England data will extract the relevant records from the HES datasets, Cancer Registrations, and Civil Registration Deaths and provide to the University of Warwick. 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 from the MAMMO-50 study held by the University of Warwick.

The data will be stored as encrypted files on servers at University of Warwick. The data will be accessed by authorised personnel, both on-site and via remote access. The data will remain on the servers at the University of Warwick at all times. The data will not be transferred to any other location. There are no off-site backup services.

The data will not leave England at any time.

Data will be accessed by individuals employed by the University of Leeds with an honorary contract with the University of Warwick. The University of Leeds employees will act as agents at all times under supervision from employees of the University of Warwick. Aside from these individuals, access is restricted to employees or agents of the University of Warwick, who have authorisation from the Chief Investigator. All personnel accessing the data have been appropriately trained in data protection and confidentiality.

The identifying details (NHS and unique person ID) will be stored in a separate database to the linked dataset used for the analysis. Date of birth is required in the linked dataset to enable derivation of the outcome data.

Researchers from the University of Leeds and University of Warwick will analyse the data for the purposes described above. Anonymised outputs of the analysis will be made available to the University of Leeds in the form of aggregate outputs with small numbers supressed in line with HES Analysis Guide to run through economic modelling software. The output from the economic modelling will be returned to the University of Warwick for inclusion in the report and publications.

Digital triage: investigating patient service use and health outcomes following triage in Urgent Care settings — DARS-NIC-353882-J5X9Q

Type of data: information not disclosed for TRE projects

Opt outs honoured: Anonymised - ICO Code Compliant, Yes (Section 251 NHS Act 2006, Does not include the flow of confidential data)

Legal basis: Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'., Health and Social Care Act 2012 – s261(2)(a); National Health Service Act 2006 - s251 - 'Control of patient information'.

Purposes: Yes (Academic)

Sensitive: Non-Sensitive

When:DSA runs 2021-08-09 — 2022-08-08 2023.02 — 2023.02.

Access method: One-Off

Data-controller type: UNIVERSITY OF WARWICK

Sublicensing allowed: No

Datasets:

  1. Emergency Care Data Set (ECDS)
  2. Hospital Episode Statistics Admitted Patient Care
  3. Hospital Episode Statistics Admitted Patient Care (HES APC)

Objectives:

Project summary:
Care services that provide out of hours care (care outside of general practice opening) often use digitally supported ‘telephone triage’. This telephone triage involves a health care service staff member using a ‘digital triage tool’, to help signpost the patient to the most appropriate service to receive health care; in part this helps health care services manage high demand. The digital triage tool is used by the clinician to input the patient’s symptoms in order to automatically generate the signposting or care advice. This research investigates how patients use these types of services. It also aims to understand how telephone triage affects patients’ use of other health care services, such as Accident and Emergency (A&E), and what happens to patients following telephone triage, in terms of their health. This study will analyse pseudonymised, pre-existing data from NHS providers in order to better understand how these telephone triage services are used and how they affect patient health. Ultimately the aim is to better understand how telephone triage is used and to identify areas for improvement that will benefit patients.

Research aims:
The two research aims below will be addressed before and after the start of the COVID-19 Pandemic;
1. How do patients use urgent care services that are delivered though telephone based digital triage?
2. How do patients use health care services following telephone based digital triage?

Objectives
The following objectives will be explored in urgent care settings both before and after the start of the Covid 19 pandemic;
1. To describe the characteristics and symptoms of patients accessing urgent care in urgent and emergency care settings.
2. To investigate associations between patient characteristics and triage disposition (triage advice generated through Odyssey).
3. To describe triage dispositions in primary and secondary triage in patients who are referred from NHS 111 for clinician triage.
4. To explore patients’ health outcomes and service use following telephone based digital triage, which will serve as indicators of appropriateness of triage and safety.
5. To draw conclusions and make recommendations of how telephone based digital triage is utilised and how it can be improved, in periods of ‘normal’ and high service use.

Care setting:
This study focuses on the use of Odyssey, a digital triage tool that has been developed by Advanced Health and Care Ltd, an NHS technology supplier (https://www.oneadvanced.com/). Clinician led triage using Odyssey in UK based urgent care settings will be explored in this study.

In this setting, a clinician uses Odyssey within an out of hours (OOH) or urgent care centre. In England, the patient will usually access the urgent care / OOH centre via NHS 111, in some cases patients may call the out-of-hours or urgent care centre directly. In either case, patients will be triaged by a clinician (usually a nurse) over the phone using Odyssey, which will result in prioritisation and advice. Advice generated by the tool may include: a face to face appointment at the centre, home visit, a routine GP appointment or self-care advice. Urgent care providers that utilise Odyssey in this way include: Mastercall (http://www.mastercall.org.uk/out-of-hours) and Practice Plus Group (PPG) https://practiceplusgroup.com/our-services/integrated-urgent-care/out-of-hours-services/.

This study ultimately aims to understand how clinician led digital triage is used in different settings and how this may be influenced by previous care advice through NHS 111 and the associated patient outcomes following triage.

The routine dataset being requested will enable several associations to be explored including the characteristics of repeat callers and access of services by particular subgroups. The study also enables the analysis of the impact of the COVID-19 pandemic on patient service use, which may provide insight on how services function in times of high service use and could feed into future planning and service delivery.

Use of data in the project:
Data is being requested for use in a PhD research project that investigates patient health and safety outcomes following the use of telephone based urgent care services. The project is led by the University of Warwick and is partly funded by a company called Advanced Health and Care ltd (https://www.oneadvanced.com/). Advanced provide digital triage software to NHS telephone based care services; the triage software is used by clinicians to generate algorithm based care advice based on a patients symptoms. Advanced will be providing the patient cohort, which is made up of patients who have been digitally triaged by a clinician.

Patient outcomes data (relating to A&E attendance and hospital admissions) linked to a cohort are being requested in this application. The research project will analyse two non-identifiable (pseudonymised) datasets: 1) patient outcomes (A&E attendance/hospital admissions) together with 2) data from telephone triage services. The project aims to understand patient safety and health outcomes, following the use of telephone based urgent care services, in order to make recommendations in how these services can be best delivered and improved.

The application is for Hospital Episodes Statistics (HES) Admitted Patient Care (APC) and Emergency Care (ECDS) datasets for a given cohort; the cohort is made up of recent users of telephone triage services in England. NHS Digital will link the patient identifiers for the cohort (provided by Advanced Health and Care) to patient outcomes in HES APC and ECDS datasets. NHS Digital will then remove the identifiable fields (NHS Numbers / data of births) before securely sending to University of Warwick as pseudonymised datasets.

The legal bases are;
GDPR article 6 (1)(f) as the data processing is necessary for a legitimate interest legal basis due to the commercial connection, this project investigates how digital triage and urgent care delivery can be improved to benefit patient care.
GDPR article 9(2)(j): as data processing is necessary for scientific research purpose.

There are minimal risks of harm; limited identifiable data will be handled by Advanced for data linkage purposes. Two identifiable data fields will be sent by Advanced to NHS Digital (DARS) for the data linkage: (NHS number and dates of births).

University of Warwick are the data controller who also process data, and are the storage location. University of Warwick are the data controller because they are conducting the research study by analysing the pseudonymised HES APC and ECDS data provided by NHS Digital. Advanced Health and Care Ltd will not have access to this data. The University of Warwick has all the prerequisite security and technical requirements and is experienced in research.

How will the data requested achieve the aim identified?
The pseudonymised HES APC and ECDS data will be linked to a separate pseudonymised triage dataset before analysis is conducted. This separate ‘triage dataset’ will be sent by Advanced to University of Warwick. The dataset is pseudonymised: all patient identifiers have been removed, leaving only a study ID corresponding to the study ID that is provided by Advanced to NHS Digital in the study cohort. The HES APC/ ECDS data will be linked to the triage dataset using this study ID. All other fields in this ‘triage dataset’ are non-identifiable, fields include: time of call to out of hours service, presenting symptoms e.g. ‘chest pain’, outcome of digital triage, which is the advice the patient is given over the telephone (e.g. urgent face to face appointment within 6 hours / routine GP appointment / self care)

The research aims to understand the rates of A&E attendances and hospital admissions in different groups of patients who have been digitally triaged by telephone based urgent care providers. ‘Groups of patients’ will be based on: presenting symptom (e.g. patients presenting with chest pain), age group (e.g. older adults, aged over 65), and sex. These groups will be identified from the triage dataset.

Linking the two datasets will allow comparison of the digital triage advice that patients are given over the phone (for example, to self care or attend A&E immediately), with their actual service use (e.g. attendance at an Emergency department or hospitalisation). For example, it will be possible to identify if patients who are recommended to “self care” when triaged over the phone, go on to attend A&E or are hospitalised; and whether this differs in groups with different presenting symptoms. This could help to identify areas for improvement in the digital triage tool (specifically the clinical content), which could improve patient safety.

Length of research:
The research will be conducted by as part of a PhD project, which commenced in October 2019 and will finish in March 2023. The PhD project is funded by University of Warwick and Advanced.

Collaborations/wider setting:
The PhD project has been designed independently by the research team (PhD student and supervisory team) at the University of Warwick. Advanced’s input is supporting with the provision of data for analysis in the research project. It is intended that the research findings will help to identify areas for improvement in the triage software, service delivery and to the international research community for the overall improvement in urgent care that is provided to patients.

The PhD project consists of a systematic review, to identify the areas of research focus; this is complete and has fed into the design of two parts of the project 1) The analysis of non-identifiable triage data and health outcomes, using data from 2019 – 2020 (as provided by Advanced) 2) An interview sub-study with service users, which are currently being planned and will take place in 2021. These two studies are independent.

Description of the data participants, including e.g. control and cohort groups:
The cohort is made up of patients/carers who have called and been triaged by a telephone based urgent care service, usually accessed via NHS 111, but in some cases patients may have called via the Covid-19 helpline (119) or have called the urgent care provider directly. This includes patients who were triaged over an 18 month period spanning 2019 – 2020. The patients have been triaged over the phone by a clinician using Odyssey which is a “digital triage tool” (a software based decision support tool, similar to ‘NHS Pathways’ used by NHS111).

Purpose of the request:
The research study investigates the use of telephone based digital triage and its impact on subsequent health care service use by patients and their health outcomes. This project is line with the Care Quality Commission’s(CQC) objectives for technology suppliers to work with researchers to better understand and improve patient outcomes relating to digital triage. There is no involvement of the CQC in this project.

Data that is required:
Data showing patients' use of A&E and hospital admissions is required for the project. The A&E / admissions data will be analysed in pseudonymised form together with a pseudonymised triage dataset, in order to investigate the relationships between triage outcomes (e.g. triage advice given to a patient) and patients compliance with advice, use of services and health outcomes.
Two datasets are being requested through DARS:
1. Admitted patient care (APC)
2. Emergency Care Dataset (ECDS)
Advanced will provide a cohort (including: pseudonymisation ID, NHS number and date of birth) for linking with the APC and ECDS data. The requested data will be linked and sent by DARS to University of Warwick with the NHS Numbers and date of births removed. The University of Warwick will keep this data for the duration of the DSA with NHS Digital and may request an extension if necessary.

Justification for the number of years requested:
Data spanning two years has been requested to allow for the analysis of data prior to and during the Covid-19 pandemic. The project has been designed with the input of a statistician and data over this time period data was deemed to be sufficient for this research.

Justification for the geographical spread of the data requested:
The cohort that will be provided to NHS Digital is based on the callers to urgent care providers that use the Odyssey digital triage tool. These urgent care providers are based in England; this is not based on any particular geographical spread.

As this study seeks to analyse a large amount of non-identifiable “historical” data (cohort size 231,419) it is not possible to collect A&E attendance / admissions data in an alternative way.

Details of any efforts taken to minimise the data required
The minimum amount of data for the research purpose has been requested. Two years of data have been requested; only the specific fields that will be used in the analysis have been requested. The requested fields have been reviewed by the supervisory team, which includes a statistician. No identifiable data has been requested in this application. The data requested relate to patients use of A&E and information about hospital admission (if any). Data requested from the ECDS relates to the patients arrival time at A&E, their chief complaint or injury, co-morbidities, whether they were admitted, investigations and treatments, and discharge.The data fields requested for admissions (APC) relate to when and how they were admitted, the reason they were admitted (diagnosis codes), procedures that were done when admitted, and the length of admission.

The cohort cannot be minimised as they are keen to discover evidence of clinical risk in the digital triage tool, which may be relatively small in size. Their initial analysis of the digital triage cohort data (which includes the referral advice that patients are given) indicates that fewer patients than anticipated are being advised to go to the ED following the digital assessment, which could mean that the system is working well or could mean that patients are being delayed access to ED. Therefore, the opportunity to include a larger cohort of patients is of value as it will lead to greater understanding of the safety of the digital triage process.

The exact cohort size was not known at the beginning of the application, and this was reflected in the CAG application, in which we stated: “A minimum of 100,000 triage cases will be analysed. This has been deemed to provide an appropriate number of A&E attendances based on previous studies. The actual number may be higher than 100,000 depending on data availability from the services however it has been established that a minimum of 100,000 cases will be available and appropriate for analysis.”

The sample size of 100,000 was a very conservative estimate to demonstrate that they did have enough power to conduct their analyses and they always expected more. In addition the sample size will increase the precision of their estimates. The increased sample size will also allow them to understand how triage works for certain patient groups, e.g. ethnic minorities.

Organisations involved
University of Warwick is the sole data controller who also process the data. University of Warwick will conduct the research, using non-identifiable data only.

The project has been designed and will be conducted independently by University of Warwick. Advanced have not been involved in the design and are not determining the purpose and the means of the data processing. They will not have any access to the linked data generated by NHS Digital. The only role that Advanced has is to provide the research cohort and supporting the research by providing non-conditional funding through the Warwick Collaborative Postgraduate Research Scholarship (WCPRS) scheme.

Advanced are a partial funder of the project; University of Warwick are the other funder.

Expected Benefits:

Whilst “digital triage” is in widespread use, and the digital triage tool investigated in this project is widely used within NHS commissioned urgent care at present, there is little real-world evaluation of its safety. The datasets disseminated by NHS Digital (HES APC, ECDS), will be analysed as part of a PhD project, which aims to provide evidence on the safety of digital triage. The project aims to understand how telephone triage affects patients’ use of other health care services (such as A&E), and what happens to patients following telephone triage, in terms of their safety and health.

The analysis will allow for the investigation of particular groups of patients, in order to understand trends in use of the healthcare system following the triage call and patient health outcomes. Particular patient groups are expected to be identified based on patterns of patient service use within the data. For example, a group may be patients who were given low urgency advice (through digital triage) but were subsequently admitted to hospital. Another example is patients who were advised to attend A&E and did not attend. Symptom based groups may include those presenting with chest pain. For example, clinical outcomes between males and females of the same age presenting with chest pain could be investigated.

This analysis will be interpreted together with findings from a planned interview study, which will investigate patient experience of services that are delivered through telephone based digital triage, to better understand the reasons why patients do or do not follow the advice given to them by telephone triage services.

Expected benefits are summarised below:

1. The research will develop an understanding of how patients use wider healthcare (A&E and hospitalisation) services after they receive digital triage advice over the telephone. Specifically, the research will investigate which groups of patients (if any) tend not to follow the advice to attend A&E that they are given through digital triage.

2. Further research being conducted as part of the PhD study will follow up on these findings through qualitative interviews with patients and carers to understand factors that influence patients’ and carers’ decisions in following the digital triage advice they are given. This may help to identify additional support required for particular groups or could feed into symptom or condition specific training of staff within urgent care providers, to improve the care delivered to patients. These changes would directly help services to improve their care delivery and benefit patients.

3. Evaluating and improving the safety of digital triage: this study aims to identify potential triage errors within the digital triage tool (an example of a triage error is ‘under triage’ where a patient is given advice that is not of a sufficient clinical urgency, for example if a patient is advised to routine care for a problem that subsequently is shown to have required urgent or immediate care). If triage errors are identified, recommendations will include suggestions for clinical content improvement with the digital triage tool. This would directly benefit patient safety.

4. The project benefits the research community through generating new knowledge.

5. The study is in support of a PhD research study.

As this is an exploratory research study it is not possible to say how many patients will benefit; however, this work is important to evaluate the safety of digital triage and to investigate potential triage errors, which has not previously been done on a large scale. Based on its findings, the project will generate recommendations for measuring improvement in service quality and outcomes.

Findings will be shared with Policymakers and commissioners through presentations at conferences and special interest group events

Dissemination of recommendations will be completed by March 2023. Changes to the improvement of the digital triage tool, following recommendations generated by this project would be implemented by Advanced.

Outputs:

Findings/Outputs will be presented in a PhD thesis.

Additionally, recommendations from this project will be presented in an oral presentation and a short written report that can feed into the design of digital triage tools, service delivery and healthcare policy. This will be in plain English (non-scientific format), which will be shared with all project stakeholders, key audiences and on social media.

Findings of the study will be disseminated through the following:

1. Oral presentations to Advanced who develop and provide the Odyssey digital triage tool. Audiences within Advanced will include leadership, clinical and product management teams. There will be an emphasis on areas for improvement in terms of service delivery and the clinical content within the digital triage tool.

2. Findings will be shared with the urgent care providers whose data is being analysed in the study: A report and presentation of findings will be offered to participating urgent care providers, including suggestions for service delivery improvements. Examples of the care providers include: Mastercall (http://www.mastercall.org.uk/services/out-of-hours-service), Bardoc (http://bardoc.co.uk/)

It is expected that audiences will include those responsible for managing service delivery, clinical staff (digital triage end users), and those responsible for training and quality assurance of digital triage tools. Findings from the research will be summarised in a PowerPoint presentation, which will be presented to audiences including policymakers and commissioners responsible for urgent care services, including members of NHS England and through special interest groups, for example the Society for Academic Primary Care (SAPC) special interest group: Digital Technologies in Primary Care.

Findings from the research will be summarised (in lay English) in a PowerPoint presentation. A written summary of findings report will also be created. The oral presentation and study reports will be shared with collaborating patient and public groups (for example: Healthwatch or GP practice patient groups) and service users who participated in the study who have indicated their interest in receiving a study report.

Findings will be written into academic research papers, which will be disseminated in peer reviewed journals (such as BJGP, BMC journals and BMJ open) and will be presented at conferences focussed on digital health and primary care. There are three anticipated papers: the systematic review, quantitative findings and mixed methods findings.

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

There will be no suppression of results or outputs by the funders. This means that if the results show anything negative towards Advanced and the Odyssey digital triage tool, that these finding will still be published.

Outputs are expected to be complete by March 2023.

Processing:

Patient identifiers for the cohort (cohort size 231,419) will flow from Advanced into NHS Digital (for which section 251 is in place to cover the common law). The patient identifiers are NHS number and date of birth, along with a pseudonymised ID (study ID). NHS Digital will link the patient identifiers to HES APC and ECDS datasets and then the identifiable fields (NHS Number and date of birth) will be removed before NHS Digital securely send the pseudonymised ID (study ID) and the requested pseudonymised fields from HES APC and ECDS datasets to University of Warwick.

Incoming data to NHS digital from Advanced: pseudonymised ID (study ID), NHS Number and Date of Birth.
Outgoing data from NHS Digital to University of Warwick: pseudonymised ID (study ID), and non-identifiable APC/ECDS fields (such as date of A&E attendance, date of hospital admission).

Stages of data processing:

1. Advanced will extract NHS number and date of birth for the cohort. They will add a pseudonymisation ID (the study ID). A file containing: NHS number, date of birth, and pseudonymisation ID will be sent securely to NHS Digital. Advanced routinely handle confidential patient information and have appropriate safeguards and staff training in place. Advanced is fully compliant with the NHS Data security and protection toolkit requirements (ODS Code 8HN06 – Advanced Health and Care Ltd).

2. NHS Digital will link the patient outcomes data (A&E and admissions data), based on the NHS number and the date of births. NHS Digital will remove the identifiable data leaving only the study ID and the non-identifiable HES APC and ECDS fields. NHS Digital will securely send the data to University of Warwick.

3. The PhD student will link the HES APC and ECDS data to an existing research ‘triage dataset’. This ‘triage dataset’ has been pseudonymised by Advanced by removing all patient identifiers; this data set will contain a pseudonymised ID (the study ID) which corresponds to the study ID that is sent by NHS Digital to the University of Warwick. The datasets will be linked by the PhD student using the study ID. It will not be possible for the University of Warwick to identify any individual from either dataset. There will be no requirement or attempt to re-identify individuals.

The analysis will be conducted by the PhD student under the guidance of a supervision team who are substantive University of Warwick employees and are appropriately trained in data protection and confidentiality. The data will be stored on a University of Warwick server and will be accessed remotely using a VPN.

The purpose of the project is to develop an understanding of how patients use healthcare after they have been digitally triaged, for example do they follow the advice they are given through digital triage, and what happens to the patient in terms of their health. In order to show how patients use services after they have been triaged, ‘descriptive’ statistical analysis will be used. This includes summarising the findings in tables using percentages and means. For example, a table will be used to show the percentage of patients who are advised to go to A&E together with the percentage who do attend and who do not attend; this will be broken down by the type of presenting symptom (e.g. respiratory or cardiovascular).

The analyses will be presented visually using bar charts and histograms. To identify any changes in how services are used before and after the start of the Covid-19 pandemic, the data will be modelled to show changes in how patients use services over time, using time series graphs. ‘Inferential’ statistics will be used to understand differences between groups. For example, we will compare the differences in health outcomes (e.g. rates of hospitalisation) between groups. Examples of groups that will be used in the analysis include groups based on: age group, sex, and presenting symptom during the telephone triage call (for example chest pain or cardiovascular symptoms). All analyses will be done using statistical software (Stata).

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).

Prevention of Shoulder Problems Trial: exercise to prevent shoulder problems in patients undergoing breast cancer treatment. — DARS-NIC-75485-J3R9B

Type of data: information not disclosed for TRE projects

Opt outs honoured: No - data flow is not identifiable, Anonymised - ICO Code Compliant, No (Consent (Reasonable Expectation))

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

Purposes: No (Academic)

Sensitive: Non Sensitive, and Non-Sensitive

When:DSA runs 2019-03-05 — 2022-03-04 2019.10 — 2019.10.

Access method: One-Off

Data-controller type: UNIVERSITY OF WARWICK

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Critical Care
  2. Hospital Episode Statistics Outpatients
  3. Hospital Episode Statistics Admitted Patient Care
  4. Hospital Episode Statistics Admitted Patient Care (HES APC)
  5. Hospital Episode Statistics Critical Care (HES Critical Care)
  6. Hospital Episode Statistics Outpatients (HES OP)

Objectives:

The University of Warwick Clinical Trials Unit will be responsible for processing the data.

The PRevention of Shoulder ProblEms TRial (PROSPER) is a multi-centre pragmatic two-arm Randomised Control Trial (RCT) examining an intervention to prevent shoulder problems in patients following breast cancer surgery. Following breast cancer surgery, it is common for women to suffer a range of postoperative symptoms in the upper arm and shoulder. These postoperative symptoms can persist for many years after treatment. The intervention in PROSPER builds upon existing evidence that exercise programmes following surgery can improve functional outcomes and reduce complications. The purpose of the PROSPER trial is to examine whether such a programme is clinically and cost-effective in comparison to usual care.

The Warwick Clinical Trials Unit has recruited approximately 380 participants into the PROSPER study. For these participants, the researchers hold identifiable data, this includes, name, postcode, date of birth, NHS number and other self-reported data including demographic characteristics, health-related quality of life, and service use. Participants have consented to the researcher holding these data and data processing regulations will be adhered to. Recruitment into the trial has now finished.

The two trial arms that are being tested within this trial are as follows:
Usual care arm: Usual care (control arm) participants continue to receive current care. Current care is characterised by patients receiving information leaflets that recommend movements and exercises that can be conducted to improve outcomes following surgery.

Treatment arm: The treatment arm (intervention arm) participants additionally receive a physiotherapist-led individually tailored exercise programme and a series of appointments to monitor and assess recovery.

The HES data requested from NHS Digital will be used to facilitate and validate the costing of the PROSPER randomized controlled trial. As part of the trial, a comprehensive economic evaluation is being conducted. The goal of the economic evaluation is to estimate the cost-effectiveness of the PROSPER intervention compared to usual care. To achieve this, a systematic comparison of both the costs and outcomes associated with the intervention relative to usual care will be conducted. Thus, there are two key components of interest: costs and outcomes.

Relevant outcomes on health and social care are being collected prospectively within the trial. To calculate the costs associated with the intervention, trial participants are completing resource use questionnaires at baseline (randomisation), and the two follow-up time points (six months and 12 months). The resource use questionnaires seek to identify all the healthcare usage; this includes hospital care, community care, social care, and medicines and drugs. Resource use questionnaires rely on patient recall and therefore may be subject to recall bias whereby individuals fail to accurately identify the resources they used in a given time frame.

The objective of processing the HES data will be to validate the hospital data collected via resource use questionnaires within the PROSPER study.

The University of Warwick require data from three different data-sets (APC, Outpatient, and Critical Care) for three years; 2015/16, 2016/17 and 2017/18 to link to trial data to allow analysis of service use for the trial cohort.

Expected Benefits:

The primary benefit is to fulfil a key requirement of the PROSPER trial, namely to estimate the cost-effectiveness of the physiotherapy intervention, compared to routine care. NICE can use this information when deciding whether to recommend physiotherapy after breast cancer surgery.

Given the frequent complications following breast cancer surgery, there is great potential for the intervention to save the NHS money in the long run, whilst improving outcomes for patients. To ensure the limited budget of the NHS is being spent efficiently, it is important to conduct a thorough examination of the cost-effectiveness of the intervention. The HES data requested should help inform an accurate assessment of the cost-effectiveness of the PROSPER intervention, and ultimately inform changes in clinical practice in the UK.

The HES dissemination of follow-up data for trial participants will be obtained during 2018 and the University of Warwick will aim to have final results and outputs ready for wider publication during 2019. The report to be published by the National Institute of Health Research HTA Programme, and linked peer-reviewed journal articles, will provide critical knowledge on the efficient delivery of shoulder rehabilitation following breast cancer surgery.

Shoulder pain is extremely common following breast cancer surgery. Should the intervention be successful there is potential to achieve great benefits in terms of reduced pain and increased mobility following breast cancer surgery. The researchers will be in a position to promote the findings of the study but unfortunately do not have the capacity or the funding to ensure the implementation beyond the lifetime of the clinical trial.

Outputs:

This is an NIHR funded study and all outputs of the trial will therefore be reported to the NIHR. The NIHR will publish the report of the PROSPER trial, including the economic evaluation, on its website.

Specific outputs include:
- The final NIHR Health Technology Assessment (HTA) Mongoraph; which will be published in 2019.
- Peer reviewed publications relating to the economic evaluation of the PROSPER trial. This will be alongside the primary clinical findings, or as a standalone paper. These will be submitted at the end of 2018 and published in 2019.
- Main trial findings will be summarised on the Warwick Clinical Trials Unit main website.
- Findings will also be disseminated via social media, this includes the Warwick Clinical Trials Twitter
page (@WarwickCTU) and Warwick Health Economics Twitter page (@HealthEconWMS).

A methodological paper comparing costing methodologies will also be considered.

The study findings will be widely promoted on Twitter and usual scientific routes, thus via national and international academic conferences and peer-reviewed publications. There are patient representatives within the research team who will also be involved with preparing materials for wider dissemination. Findings will feedback to patient groups who provided input to the early development phases of the trial.

Processing:

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).

The processing activities are as follows:

1) Patient identifiers are being recorded for participants within the PROSPER trial at The University of Warwick Clinical Trials Unit (WCTU).

2) The University of Warwick will send in the following identifiers to NHS Digital for linkage to the HES Data:
• NHS number
• Date of birth
• Postcode
• Unique Study ID

3) NHS Digital will be responsible for linking the patient identifier(s) to HES data. NHS Digital will return pseudonymised HES data, with the unique study ID linked to the PROSPER cohort. This will allow the researchers to validate responses from the questionnaires.

4) Warwick Clinical Trials Unit will store these data on a server at the University of Warwick which can only be accessed by those granted authorisation by the Chief Investigator. All staff involved in the study at the Warwick Clinical Trials Unit are substantive employees at the University of Warwick.

5) The University of Warwick health economists will calculate costs of hospital care using the HES data for participants within the PROSPER trial. The HES data costs will be used to assess the validity of the PROSPER resource use data.

There will be no requirement or attempt to re-identify individuals from the data. HES data will be stored separately from any data that allows identification, other than Unique Study ID which will be used to link the questionnaire data.

The University of Warwick require data from three different data-sets (APC, Outpatient, and Critical Care) for three years; 2015/16, 2016/17 and 2017/18 to link to trial data to allow analysis of service use for the trial cohort.

The first dissemination of data will be just for the years 2015/2016 and 2016/2017. This will provide baseline and six month follow up data for approximately 100 patients.
The second download will include 2017/2018 data. This will provide baseline and six month data for all participants, as well as 12 month follow up data for approximately two-thirds of the patients within the PROSPER trial.
Data for 2018/19 which would give the final time-point for the other third of participants are not being requested as it would not allow time for analysis before the study ends. The University of Warwick have been selective in the variables requested; choosing only those which may aid the analysis. No unnecessary sensitive variables are being requested. Any potentially sensitive data e.g. data relating to Trusts will not be published.

The University of Warwick aim to examine whether there is any systematic bias within the self-report data. Trial data will rely on self-report resource usage, however, this is subject to recall bias. The University of Warwick will therefore use HES data alongside trial data to calibrate trial costs, there will be no linkage of any other trial data to the HES data.

Costing using the HES data will require the use of the reference cost grouper. The costs as calculated through trial data will be compared to that of the HES data. The University of Warwick will assess whether there is concordance between the HES data and the self-report data. If any systematic discordance is found between the two data sets then resource use for those who the researchers do not have HES data for will be adjusted accordingly.

All outputs will be restricted to aggregated data with small numbers suppressed in line with the HES Analysis Guide.

The data from NHS Digital will not be used for any other purpose other than that outlined in this Agreement.

The data from NHS Digital will not be linked to any other data other than those outlined in this Agreement.

Warwick Clinical Trials Unit will store these data on a server at the University of Warwick which can only be accessed by a restricted number of personnel.

Modelling the Frailty Patient Pathway — DARS-NIC-32537-Y2H2L

Type of data: information not disclosed for TRE projects

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

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

Purposes: No (Academic)

Sensitive: Non Sensitive, and Non-Sensitive

When:DSA runs 2018-12-20 — 2021-12-19 2019.07 — 2019.07.

Access method: One-Off

Data-controller type: THE SHREWSBURY AND TELFORD HOSPITAL NHS TRUST, UNIVERSITY OF WARWICK

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Admitted Patient Care
  2. Hospital Episode Statistics Accident and Emergency
  3. Hospital Episode Statistics Outpatients
  4. Hospital Episode Statistics Accident and Emergency (HES A and E)
  5. Hospital Episode Statistics Admitted Patient Care (HES APC)
  6. Hospital Episode Statistics Outpatients (HES OP)

Objectives:

The University of Warwick and Shrewsbury and Telford Hospital Trust (SaTH) are undertaking a study as part of their drive to improve pathways for older people with complex needs, and wish to undertake modelling of hospital older patient pathways. The study is funded by the Warwick Collaborative Postgraduate Research Scholarship Scheme. The scheme funds a University of Warwick student to undertake research under the supervision of the University. Whilst the PhD student (formerly a Masters student at the University of Kent) is under sole supervision by the University of Warwick, SaTH originally instigated the work, are contributing to the nature of the work by providing advice and guidance on the aims of the research, and are supporting dissemination of the findings. The University of Warwick (i.e. the PhD student and supervisor) will have sole access to the record level data requested of/supplied by NHS Digital. SaTH will not have access to the data.

This research seeks to answer the following questions: what are the patient pathways followed by complex older patients and what are the associated effect on the health outcomes and resource utilisation. The main aim of this research is to determine the typology of older patient pathways and determine the association between these pathways and their health outcomes. This research aims to inform on the care trajectories of complex older patients in hospital to determine the variations that exist between their care trajectories, within groupings of older patients, the causes of these variations and the effect on outcomes and resource use. The University of Warwick contend that utilization of healthcare services can be grouped into a limited number of care trajectories. Knowledge of care trajectories and their components may be used to adjust treatment goals, enhance healthcare management, and improve efficiency and cost-effectiveness, resulting in higher value of care. Identifying care trajectories as well as parameters associated with trajectories (that is, their correlates) could have important clinical and administrative implications, such as treatment planning and allocation of resources. This information will be of value to efforts in establishing consistent processes that meet the needs of this patient population either by service redesign or by creating new services.

This research will contribute to existing literature on modelling and segmentation of patient pathways. However, this research is new in that it focuses on older patients and uses Hospital Episode Statistics data to capture actual flows and uncover hidden workflows. This research aims to utilise the Hospital Episode Statistics dataset to extract the patterns of care that represent the actual patient journeys of older people presenting with complex needs and uncover unknown workflows. Hospital Episode Statistics include data fields that define a patient’s previous and subsequent healthcare contacts. Therefore, it is possible to build the care trajectories of patients spanning from the main points of entry to inpatient acute care and finally discharge. Hospital Episode Statistics data from 2011/12-2016/17 is therefore requested on individuals aged 65 years and above at the start of the episode. The data years requested will allow for the analysis of the evolution of the care trajectories and trends in resource use.

Expected Benefits:

The aim of the research project arose is to improve services for older people with complex needs. Analysis of hospital care trajectories of complex older patients is not available elsewhere. The study will contribute to the novel use of administrative hospital data to understand the complexity of older patients in the context of general flow through the main portals of entry into the main ward areas and back to the community. Complex older patients are characterised as having heterogeneous needs and therefore have many configurations of healthcare utilisation within their episodes of care. However, disparities between episodes of care can be limited to local context and patient characteristics. Therefore, differences among episodes of care can be grouped into care trajectories made up of a series of contiguous healthcare services. Synthesis of care trajectories and their corresponding effect on outcomes of complex older patients and associated resource use will support service re-configurations and design by understanding this patient population needs that can be assessed by clustering care trajectories according to patient profiles and assessing disparities in hospital care consumption between the emerging groups.

Understanding the care trajectories of older people can help care providers configure services to improve the care of older people in and outside of the hospital. For clinicians, the identification of patient and disease characteristics associated with specific trajectories enables clinicians to identify and perhaps predict complex cases that may require special attention or a greater use of healthcare services. For administrators, identifying trajectories allows for more accurate budget planning and allocation of resources based on service utilization rates. Lastly, the care trajectories can be used as an evidence-based tool to identify patient and disease characteristics associated with greater use of healthcare resource, to plan and allocate resources based on service utilisation or isolate problem areas. The results and findings of this project will be disseminated widely via the methods described above, targeting practitioners, academic audiences, and patients/the general public.

Outputs:

The expected outputs from this study is a methodology for longitudinal care pathway analysis using administrative data and a typology of older patient emergency care pathways. Outputs from the study are to be realised at the completion of the PhD thesis. All outputs will contain only data that is aggregated in lined with the HES analysis guide. The key audiences for this research are commissioning organisations, academics and the public. The dissemination strategy is as detailed below.

The typology of care pathways will reveal information about core treatment processes and can be used to support decision making in terms of demand profiling that can aid in care process redesign towards patient focused care and care co-ordination actions on the mix of resources required based on patient presentations. Therefore, the typology of care pathways will be disseminated through presentations will be made to various steering group meetings made up of NHS service providers within and across CLAHRC as well as to an International Scientific Dissemination group through NIHR CLARHC. NIHR CLAHRC is an initiative to create lasting and effective collaboration across health and social care organisations, universities and local authorities with the aim of improving services delivered to patients. Theme 5 - Implementation and Organisational Studies is aimed at providing insights into management and implementation of service change process. NIHR CLAHRC runs a news blog that has a membership of over 800 people comprising of academic and NHS service providers and is circulated widely via social media. Lastly, NIHR CLAHRC has a number of Patient and Public Involvement advisors who engage with community groups to raise awareness and disseminate knowledge about its research activities. This engagement also involves participating in public facing events such as the Birmingham University Research Think-tank Pop-up. In line with NIHR ‘make it clear’ campaign a lay summary of the research findings will be published on NIHR CLAHRC website and circulated widely through social media and NIHR CLAHRC Patient and Public Involvement Advisors.

The methodology will be disseminated to the NHS-R community. This is a community that promotes the use of Research in the NHS. The community runs a blog that reaches analyst and service providers in the NHS. Additionally, Academic research paper(s) will be published in high impact, peer-reviewed journals on the study methodology and the typology of emergency care pathways. The target peer review journals are the BMC Healthcare Service Research, Health Services Management Research, Health Care Management Science and Operations Research for Health Care; European Journal of Operations Research. Targeted conferences are Informs Healthcare 2019, YoungOR 2019 and HSRUK Conference.

Lastly, the full PhD thesis will be available for download from the University of Warwick’s open access Warwick Research Archive Portal; Warwick WRAP.

Processing:

NHS Digital will securely transfer the pseudonymised dataset consisting of the Outpatient, A&E and Admitted Patient Care records to the University of Warwick. The University will store data on a server at the University, which will be accessed at the University by the PhD student and supervisor only, as per the data sharing agreement. The datasets will be held on a password protected and encrypted drive at the University.

Linkage of the data provided by NHS Digital is not required, and is therefore not permitted under this agreement. There will be no requirement or attempt to re-identify individuals from the data. The data will not be made available to any third parties other than in the form of aggregated outputs with small numbers suppressed in line with the HES Analysis Guide.

The analysis undertaken by the project is monitoring the evolution of the utilisation of hospital services over time to develop comprehensive measures of long-term health trajectories and describe disparities in long-term health transitions and trajectories to examine individual or subgroup differences in health.

The data is minimised by age (i.e. those aged over 65 years of age), by the number of data fields required (41% for HES Admitted Patient Care, 61% for HES accident and emergency, and 48% for HES Outpatients), and by region (East and West Midlands of England only). Older patients with complex needs commonly present at hospital with non-specific symptoms/conditions. Therefore, the study requires wide ranging hospital episode data of individuals aged above 65 years and above not restricted to specific types of episodes.

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

All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract ie: employees, agents and contractors of the Data Recipient who may have access to that data). NHS Digital draws to the attention of the University of Warwick that NHS Digital regards the University of Warwick as being responsible for the actions and omissions of the PhD student.

Safety and feasibility evaluation of tourniquets for total knee replacement (SAFE- TKR) — DARS-NIC-120848-R6V4C

Type of data: information not disclosed for TRE projects

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

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

Purposes: No (Academic)

Sensitive: Non Sensitive, and Non-Sensitive

When:DSA runs 2018-11-29 — 2021-11-28 2019.07 — 2019.07.

Access method: One-Off

Data-controller type: UNIVERSITY OF WARWICK

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Outpatients
  2. Hospital Episode Statistics Admitted Patient Care
  3. Hospital Episode Statistics Admitted Patient Care (HES APC)
  4. Hospital Episode Statistics Outpatients (HES OP)

Objectives:

The objective of the research and data request is to look for surgical complications including episodes of postoperative venous thromboembolism (VTE) and cerebrovascular accident (CVA) in patients undergoing total knee replacement (TKR) surgery with or without a tourniquet. The research relates to one component of a much larger feasibility study, which is an observational study only and is not a trial. Therefore, this agreement relates to this one component only.

The data required for this research study is hospital episode statistics (HES) including diagnostic codes and length of hospital stay for the initial surgery for patients who underwent TKR surgery in 2003. HES diagnostic codes are required for these patients up to a year after surgery i.e. up to 2004.

The National Joint Registry (NJR) will provide NHS digital with a list of identifiers (NHS number, date of birth, and postcode) for patients who had TKR surgery from April 2003 to December 2003. The NJR collected data on the use of tourniquets for TKR surgery in England and Wales from April 2003 and December 2003 only which is why this time period has been selected. This dataset can then be linked to the HES data requested to undertake the research at the University of Warwick.

Many lower limb orthopaedic operations, including TKR surgery, are undertaken with the aid of a tourniquet around the thigh during the procedure. A tourniquet is an occlusive device which holds air under pressure (when inflated) and squeezes the thigh (including the blood vessels within the thigh). A survey in 2010 found that 95% of surgeons in the USA use a tourniquet for TKR surgery, and the National Joint Registry (NJR) reported that 93% of primary TKRs were done with a tourniquet in 2003. The reasons for such widespread use of tourniquets for TKR surgery are not clear. Anecdotally, surgical custom and practice has always involved a tourniquet when carrying out orthopaedic surgery below the level of the thigh and use of a tourniquet may improve the surgical field of view by limiting intraoperative blood loss. The majority of TKR components are cemented in situ to hold and stabilise them in the correct position on the bone. Cement which is initially soft when it is inserted interdigitates into the porous bone forming a strong bond to the bone as it sets. Some surgeons believe that using a tourniquet helps reduce bleeding from the porous bone ends and allows the soft cement to bond more effectively, but this is not supported by any research evidence. It is true that better cementation should reduce the chance of a TKR loosening and failing, but effective, and identical, cementation is routinely achieved in hip replacement surgery where the use of a tourniquet is not possible. In such surgery it is accepted that the absence of a tourniquet does not compromise the surgical field of view, cause excessive intraoperative blood loss or lead to long term problems with implant survivorship.

In TKR a tourniquet causes both arterial and venous stasis within the lower leg for the duration that it is inflated (typically over an hour). The increased risk of symptomatic Venous Thromboembolism (VTE) following major surgery, whether joint replacement or other has been known for many years. Routine measures including low molecular weight heparin, anti-embolism stockings and pneumatic calf compression devices following all such surgery are recommended by National Institute for Health and Care Excellence (NICE), subject to contraindications. It is therefore unsurprising that the use of a surgical tourniquet might increase the risk of post-operative symptomatic VTE. VTE is a spectrum of disease, ranging from deep vein thrombosis (DVT), through to potentially fatal pulmonary embolism (PE). The risk of VTE is already known to be higher amongst hospital inpatients, including those who have not had a surgical procedure, and brings a considerable risk of morbidity and mortality. Even non-fatal VTE may produce long-term morbidity including chronic venous insufficiency, which may cause venous ulceration and development of a post-thrombotic limb (chronic pain, swelling and skin changes in the affected limb following a DVT). Considerable efforts are made to minimise the risk of VTE in TKR surgery using all or some of the measures already described. Crucially, empirical data indicates no measurable reduction in VTE or mortality after TKR surgery despite increased prescribing of low molecular weight heparin following NICE guidelines published in 2007.

Expected Benefits:

This research will provide answers to important safety concerns about the use of tourniquets in knee replacement surgery. The safety concern of interest is whether using a tourniquet increase a patients' risk of developing bloods clots in the leg (DVT), lung (PE) or brain (CVA). Analysis of this historic data may prevent the need for further large prospective studies of patients to examine this safety concern. Furthermore if a serious safety concern is identified this is likely to lead to a recommendation to the Medicines & Healthcare products Regulatory Agency (MHRA) for a change in surgical practice and withdrawal of tourniquets for use in knee replacement surgery and ma. Such a change in practice would make surgery safer for future patients undergoing knee replacement surgery and avoid unnecessary risk. Not only will this help patients but it will reduce the costs to the NHS of managing surgical complications.

The aim is to publish the results in at least one major peer-reviewed publication by the end of the study. It is hoped that this research will assist NICE in updating the clinical pathway for VTE which includes guidance for elective hip and knee replacement surgery and the specific NICE clinical guideline “CG92 VTE: reducing the risk”. The University will be working with the Cochrane Musculoskeletal Group to produce a full Cochrane Review on the safety and benefit of thigh tourniquets for TKR surgery. The review will incorporate data from this research. Full Cochrane reviews which have an ethos of avoiding too much medical jargon and producing detailed “lay summaries” helps to ensure these open access reviews have significant impact not only within the research community but also amongst patients, the public and policy makers including NICE.

Outputs:

The main outcomes from the proposed research will be evidence of the safety or otherwise of the use of tourniquets in TKR surgery.

The results of this research will be disseminated to the following groups:

1. Patients and public
A public and patient workshop on the proposed research found consensus that the internet should be used whenever possible to disseminate the results. Led by a patient co-applicant and other PPI collaborators the University of Warwick will develop a study Facebook page and Twitter feed. These will track both the progress of the study and eventual results and will allow people with an interest to have access to our findings in a contemporary and user-friendly way. Results will be presented in magazines such as Arthritis Today, and the study team will work with NHS Choices to prepare patient information for use after the study.

2. Medical community
A large body of specialists including nurses, physiotherapists, occupational therapists, physicians, general practitioners, anaesthetists and orthopaedic surgeons typically manage patients before, during and after TKR surgery in secondary and tertiary care centres. These groups will be targeted through conferences, seminars and meetings. All key findings from the study will be presented at national and international conferences such as the British Orthopaedic Association (BOA); British Association of Specialist Knee Surgeons (BASK) and American Academy of Orthopaedic Surgeons (AAOS). The annual conferences of the BOA and the AAOS have attendances of 1,600 and 32,000 surgeons respectively. The results of the research are likely to attract significant attention at meetings; particularly as the presentation of RCT evidence in this field is rare.

The aim is to publish the results in at least one major peer-reviewed publication by the end of the study. The University will be working with the Cochrane Musculoskeletal Group to produce a full Cochrane Review on the safety and benefit of thigh tourniquets for TKR surgery. The review will incorporate data from this research.

Processing:

The pseudonymised data received from NHS digital will be processed by the research team based at Warwick Clinical Trials Unit at the University of Warwick. The data will be stored on secure University Servers based at Warwick Clinical Trials Unit. Data will only be accessed by individual study team members, who have authorisation from the Chief Investigator to access the data for the purposes described, all of whom are substantive employees of the University of Warwick.

The data will be imported in to STATA statistics programme and processed to look for surgical complications up to 12 months including episodes of postoperative venous thromboembolism (VTE) and cerebrovascular accident (CVA). Once analysed a report will be prepared based upon the data findings and submitted to NIHR and for peer review publication.

Identifiers (NHS number, date of birth and postcode) from the NJR dataset will be securely transferred to NHS Digital for linkage to the HES admitted patient care and outpatient’s data for the cohort. Other variables will also be used for optimum linkage (study ID, gender and date of surgery). A pseudonymised dataset linked to the cohort will then be provided under this agreement to the University of Warwick by secure transfer. The study team at the University of Warwick will not have access to or process any patient identifiable information. The data will be linked at a record level to ensure details of surgical complications are accurate.

The data will not be made available to any third parties except in the form of aggregated outputs with small numbers supressed in line with the HES Analysis guide. The University of Warwick are requesting only two years’ worth of data to look for surgical complications which may have resulted due to using a tourniquet in knee replacement surgery.

All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by "Personnel" (as defined within the Data Sharing Framework contract i.e. employees, agents and contractors of the Data Recipient who may have access to the data.)

HES data is held by NHS digital. Linkage of the two datasets (HES and NJR) will be undertaken by NHS digital. NJR data is controlled by the Healthcare Quality Improvement Partnership (HQIP) who acts as ‘host’ to the NJR. NJR data is processed by Northgate Public Services (UK) Ltd (NPS). NPS is contracted by HQIP to provide the data collection, aggregation, and reporting services for the NJR.

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

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

MR1455 - PARAMEDIC2 (Prehospital Assessment of the Role of Adrenaline: Measuring the Effectiveness of Drug administration In Cardiac arrest) (s251 cohort) — DARS-NIC-56872-T9B0J

Type of data: information not disclosed for TRE projects

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

Legal basis: Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'.

Purposes: No (Academic)

Sensitive: Sensitive

When:DSA runs 2019-08-20 — 2022-08-19 2018.10 — 2018.12.

Access method: One-Off

Data-controller type: UNIVERSITY OF WARWICK

Sublicensing allowed: No

Datasets:

  1. MRIS - List Cleaning Report
  2. Civil Registration (Deaths) - Secondary Care Cut
  3. Hospital Episode Statistics Accident and Emergency
  4. Hospital Episode Statistics Admitted Patient Care
  5. Hospital Episode Statistics Critical Care
  6. Hospital Episode Statistics Outpatients
  7. Civil Registrations of Death - Secondary Care Cut
  8. Hospital Episode Statistics Accident and Emergency (HES A and E)
  9. Hospital Episode Statistics Admitted Patient Care (HES APC)
  10. Hospital Episode Statistics Critical Care (HES Critical Care)
  11. Hospital Episode Statistics Outpatients (HES OP)

Objectives:

This agreement is for the University of Warwick to receive and process Hospital Episode Statistics (HES) data and mortality data for inclusion in the PARAMEDIC2 trial. The PARAMEDIC 2 trial is a double-blind randomised placebo-controlled trial aiming to evaluate how safe and effective adrenaline is as a treatment for patients who suffer out of hospital cardiac arrest. The University of Warwick are the sole data controller who processes data under this agreement.

Over 50,000 people die each year following an out of hospital cardiac arrest (OHCA) in the UK. Although initial resuscitation efforts restart the heart in about 25-30% of resuscitation attempts, most of these patients die in the next few days in hospital from severe brain damage and overall survival (of attempted resuscitations) is less than 10%. Cardiac arrest causes a major burden on NHS resources (emergency treatment, post resuscitation care, rehabilitation) but treatment currently has a low chance of success. These dire outcomes have huge personal costs for patients and their families.

Adrenaline has been used as part of the treatment for cardiac arrest for many years. It works by increasing the blood supply to the heart. This makes it more likely that the heart will start beating again. There are, however, side effects of adrenaline treatment for cardiac arrest. Notably the heart may be overstimulated, so it pumps inefficiently, reducing blood flow to the brain, which increases the risk of death over subsequent hours and days, and of survivors having serious brain damage.

Recently scientists have looked again at what is known about how adrenaline affects outcome after a cardiac arrest. There is a consistent pattern across research studies (including more than 450,000 patients in total), which suggests adrenaline improves initial survival but may lower overall survival and increases brain damage. The data are not strong enough to mandate a change in current practice but there are real concerns in the clinical and academic community that current practice may be harming patients. Whether the practice of giving adrenaline is effective or not therefore remains an important question that needs to be answered. Resolution of this uncertainty is urgent, as adrenaline is used widely to treat cardiac arrests, and if harmful, may be responsible for many avoidable deaths.

In light of these concerns, the International Liaison Committee on Resuscitation (ILCOR) has concluded there is an urgent need for a definitive randomised, placebo-controlled trial that directly compares adrenaline with no adrenaline. A Randomized Controlled Trial (RCT) of adrenaline has the support of key stakeholders such as the College of Paramedics, Ambulance Medical Service Directors, Joint Royal College Ambulance Liaison Committee, Resuscitation Council (UK), patient representatives.

The trial enrolled, and collected data on, 8000 patients who have been treated for cardiac arrest. All surviving patients were invited to take part in follow-up to find out about patients' health and quality of life after cardiac arrest. Recruitment to this trial has finished and there will be no further recruitment.

The objective for processing data from NHS Digital is to collect data on survival, which form both the primary and secondary trial outcomes, as well as to collect data from HES to tell the University of Warwick of a patient's length of stay in Intensive Care Unit (ICU) and hospital (trial secondary outcomes). Hospital Episode Statistics data will also be used in health economics analysis, alongside other data collected in patient questionnaires, to determine whether the use of adrenaline is cost-effective.

Yielded Benefits:

The main results of the PARAMEDIC2 trial were published in the New England Journal of Medicine in July 2018. Results were reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines and outputs within this publication contain aggregated data only. The main results paper has received one of the highest attention scores (10th out of nearly 25,000 articles) ever published by the New England Journal of Medicine and was listed at #27 in the Altmetric Top 100 articles of 2018. The results are expected to influence resuscitation guidelines worldwide and are prompting discussions around the world about what the priorities and most important outcomes for patients are. The results have been presented at conferences e.g. European Resuscitation Council Congress in October 2018 as well as to key stakeholders to ensure that results are communicated rapidly to those who will put them into practice. The main results were presented to the International Liaison Committee on Resuscitation who have developed a draft Consensus on Science with Treatment Recommendations (CoSTR). https://costr.ilcor.org/document/vasopressors-in-adult-cardiac-arrest. The final CoSTR will be published in October 2019 which will inform resuscitation guidelines around the world. There is good evidence of penetration of these recommendations into clinical practice within 1-2 years of their publication. In addition, ILCOR run an on-going evidence evaluation process whereby new studies are identified and incorporated in to systematic reviews. The outputs from these reviews are shared with national resuscitation councils such as Resuscitation Council (UK) and from the basis for the development and revision of national guidelines. Results of the trial have also been communicated to the public via news articles. An infographic lay summary of the results has been sent to clinicians, participants and their legal representatives, and has been made available for download on the trial website. https://warwick.ac.uk/fac/sci/med/research/ctu/trials/critical/paramedic2/results/leaflet_patients.pdf A synthesis of current evidence on adrenaline, including the trial results has been published in Cochrane Library “Adrenaline and vasopressin for cardiac arrest (Review). (doi: 10.1002/14651858.CD003179.pub2) In addition “The effects of adrenaline in out of hospital cardiac arrest with shockable and non-shockable rhythms: Findings from the PACA and PARAMEDIC-2 randomised controlled trials” has been published in Resuscitation. (doi: 10.1016/j.resuscitation.2019.05.007)

Expected Benefits:

The trial is due to be completed on 31st July 2019 (NIHR have extended their support to this date) and the University expects the output from this trial will impact international resuscitation guidelines. There are established pathways through which advances in resuscitation science can be rapidly implemented into practice.

The University will ensure that the results of this trial are fed into the ILCOR evidence assessment and guideline process. ILCOR run a 5 yearly review of resuscitation science from which international CPR guidelines are created. There is good evidence of penetration of these guidelines into clinical practice within 1-2 years of their publication. In addition, ILCOR run an on-going evidence evaluation process whereby new studies are identified and incorporated in to systematic reviews. The outputs from these reviews are shared with national resuscitation councils such as Resuscitation Council (UK) and from the basis for the development and revision of national guidelines.

Guidelines used by the NHS are based on recommendations from the Resuscitation Council UK (RCUK) and are implemented within NHS Ambulance Trusts through the JRCALC. Key investigators on the trial also hold senior positions within the Resuscitation Council so they will be aware of the work and the results. It is likely that the trial findings will be presented at a RCUK national conference.

The applicant anticipates that the impact of this trial will be sufficient to determine future policy in this area.

Outputs:

The results of the PARAMEDIC2 trial have the potential to influence resuscitation guidelines worldwide, therefore trial results will be submitted for publication and disseminated as quickly as possible.

The University will submit the final trial results for publication in a high impact, open access peer reviewed journal such as The New England Journal of Medicine or The Lancet once data analysis is complete. Outputs will contain aggregate data only. Small numbers will be suppressed in line with the HES analysis guide. In addition, the University will present the results at scientific conferences, and to key stakeholders, such as ambulance services (National Ambulance Service Medical Directors and Joint Royal College Ambulance Liaison Committee (JRCALC))).

The trial will be reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The main publications will be the report to the funding body (NIHR Health Technology Assessment (HTA) Monograph) and a NIHR journal publication. In addition, the results will be presented at international conferences. This will ensure that the results are communicated rapidly to those who will put them into practice. The University will inform the ILCOR to ensure the results will be incorporated into national and international resuscitation guidelines via existing guideline development groups, which include several of the trial co-investigators.

The University will incorporate the findings of the trial into relevant review articles and ensure the findings of the trial are available through NHS Evidence. The University will work with their Marketing and Communication team to develop a strategy for communication with the media (television, radio, newspaper etc) to enhance communication of the trial results to patients / participants.

The University will produce a lay summary of the trial results with their public and patient involvement partners that include the trials management group (monthly meeting), the independent trial steering committee that meets on a bi-annual basis and the University Patient and Public Involvement (PPI) Group (UNTRAP) that meets annually. All groups have lay representation and participants from variety of backgrounds. This will be disseminated through their press officer, user groups, websites and INVOLVE database (an NIHR PPI network) to participants of the trial who indicated they wanted to know the results.

All outputs and publications contain only aggregated data with small numbers suppressed in line with the HES Analysis Guide.


Processing:

PARAMEDIC2 patients (or their legal representatives) were approached for consent for further data collection once they had reached the hospital ward. At that point they could consent to, or opt out of, further data collection.

This agreement relates to the cohort who were declared deceased so could not be approached for consent, as well as non-responders (those that approached for consent and have not opted out of further data collection). As it is not possible to gain consent from these patients the trial has section 251 support for both categories of individuals.

The same patient identifiers and data will flow between Warwick Clinical Trials Unit and NHS Digital for the section 251 cohort and the consented cohort. No identifiers will be submitted, and no data will be requested for patients who have declined consent for further data collection.

Data submitted to NHS Digital for linkage will include identifiable data (Forename, Surname, NHS number, address, postcode, date of birth and gender). A file will be submitted containing the details of section 251 cohort. National patient opt outs will be applied to the section 251 cohort, as the consented cohort have provided explicit consent for this data processing activity.

Data from NHS Digital will be downloaded via the secure web portal and stored in a PGP-encrypted file by a member of the trial team at University of Warwick. Only approved users who are members of the research team and substantive employees of the University of Warwick will access this folder. All individuals must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract i.e.: employees, agents and contractors of the Data Recipient who may have access to that data).

Fact of death and date of death will be used to determine whether patients enrolled in the trial survived up to 30 days (the primary outcome measure) and up to 12 months post cardiac arrest (secondary outcome measures). This will be combined with other data on the cardiac arrest e.g. treatments, neurological outcome and health status for the purposes of analysis, in order to answer the key trial question on the effectiveness of adrenaline. Data will be analysed using an anonymous Trial Identification number. Data will also be used to make sure a patient is alive before writing to them or their legal representative, to avoid causing any distress to relatives.

Hospital Episode Statistics data will be used be used as part of the health economic analysis. The HES data will be combined with other data collected during the trial (for example cardiac arrest data, patient questionnaire data) to determine the clinical and cost-effectiveness of adrenaline.

Data from NHS Digital will not be stored, processed or be in any other way accessible to any organisation except for the University of Warwick, as described in this agreement. No flow of data from NHS Digital is permitted to NICOR, ICNARC or any organisation other than the University of Warwick, and no flow of data into NHS Digital is permitted other than from the University of Warwick.

Warwick Clinical Trials Unit will also be requesting data from other hospital datasets (ICNARC and NICOR). Data from HES, ICNARC and NICOR will be combined via a 4-digit trial identification number. Patient identifiable details are already collected as part of the PARAMEDIC2 trial. However, the University of Warwick require identifiable data to be flowed back to them following the ‘list clean’ to ensure they have a complete and accurate set of patient identifiers for further data linkage with other datasets (ICNARC and NICOR). It cannot be pseudo-anonymised data as this would result in sub-optimal data linkage with other hospital datasets. The University of Warwick will not link the data further, as only the data linkages described are permitted under this agreement.


MR1454 - PARAMEDIC2 (Prehospital Assessment of the Role of Adrenaline: Measuring the Effectiveness of Drug administration In Cardiac arrest) (Informed consent cohort) — DARS-NIC-150856-G6P5R

Type of data: information not disclosed for TRE projects

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

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

Purposes: No (Academic)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2019-08-20 — 2022-08-19 2018.10 — 2018.12.

Access method: One-Off

Data-controller type: UNIVERSITY OF WARWICK

Sublicensing allowed: No

Datasets:

  1. MRIS - List Cleaning Report
  2. Civil Registration (Deaths) - Secondary Care Cut
  3. Hospital Episode Statistics Accident and Emergency
  4. Hospital Episode Statistics Admitted Patient Care
  5. Hospital Episode Statistics Critical Care
  6. Hospital Episode Statistics Outpatients
  7. Civil Registrations of Death - Secondary Care Cut
  8. Hospital Episode Statistics Accident and Emergency (HES A and E)
  9. Hospital Episode Statistics Admitted Patient Care (HES APC)
  10. Hospital Episode Statistics Critical Care (HES Critical Care)
  11. Hospital Episode Statistics Outpatients (HES OP)

Objectives:

This agreement is for the University of Warwick to receive and process Hospital Episode Statistics (HES) data and mortality data for inclusion in the PARAMEDIC2 trial. The PARAMEDIC 2 trial is a double-blind randomised placebo-controlled trial aiming to evaluate how safe and effective adrenaline is as a treatment for patients who suffer out of hospital cardiac arrest. The University of Warwick are the sole data controller who processes data under this agreement.

Over 50,000 people die each year following an out of hospital cardiac arrest (OHCA) in the UK. Although initial resuscitation efforts restart the heart in about 25-30% of resuscitation attempts, most of these patients die in the next few days in hospital from severe brain damage and overall survival (of attempted resuscitations) is less than 10%. Cardiac arrest causes a major burden on NHS resources (emergency treatment, post resuscitation care, rehabilitation) but treatment currently has a low chance of success. These dire outcomes have huge personal costs for patients and their families.

Adrenaline has been used as part of the treatment for cardiac arrest for many years. It works by increasing the blood supply to the heart. This makes it more likely that the heart will start beating again. There are, however, side effects of adrenaline treatment for cardiac arrest. Notably the heart may be overstimulated so it pumps inefficiently, reducing blood flow to the brain, which increases the risk of death over subsequent hours and days, and of survivors having serious brain damage.

Recently scientists have looked again at what is known about how adrenaline affects outcome after a cardiac arrest. There is a consistent pattern across research studies (including more than 450,000 patients in total), which suggests adrenaline improves initial survival but may lower overall survival and increases brain damage. The data are not strong enough to mandate a change in current practice but there are real concerns in the clinical and academic community that current practice may be harming patients. Whether the practice of giving adrenaline is effective or not therefore remains an important question that needs to be answered. Resolution of this uncertainty is urgent, as adrenaline is used widely to treat cardiac arrests, and if harmful, may be responsible for many avoidable deaths.

In light of these concerns, the International Liaison Committee on Resuscitation (ILCOR) has concluded there is an urgent need for a definitive randomised, placebo controlled trial that directly compares adrenaline with no adrenaline. An Randomized Controlled Trial (RCT) of adrenaline has the support of key stakeholders such as the College of Paramedics, Ambulance Medical Service Directors, Joint Royal College Ambulance Liaison Committee, Resuscitation Council (UK), patient representatives.

The trial enrolled, and collected data on, 8000 patients who have been treated for cardiac arrest. All surviving patients were invited to take part in follow-up to find out about patients' health and quality of life after cardiac arrest. Recruitment to this study has finished and there will be no further recruitment.

The objective for processing data from NHS Digital is to collect data on survival, which form both the primary and secondary trial outcomes, as well as to collect data from Hospital Episode Statistics to tell the University of Warwick of a patient's length of stay in Intensive Care Unit (ICU) and hospital (trial secondary outcomes). Hospital Episode Statistics data will also be used in health economics analysis, alongside other data collected in patient questionnaires, to determine whether the use of adrenaline is cost-effective.

Yielded Benefits:

The main results of the PARAMEDIC2 trial were published in the New England Journal of Medicine in July 2018. Results were reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines and outputs within this publication contain aggregated data only. The main results paper has received one of the highest attention scores (10th out of nearly 25,000 articles) ever published by the New England Journal of Medicine and was listed at #27 in the Altmetric Top 100 articles of 2018. The results are expected to influence resuscitation guidelines worldwide and are prompting discussions around the world about what the priorities and most important outcomes for patients are. The results have been presented at conferences e.g. European Resuscitation Council Congress in October 2018 as well as to key stakeholders to ensure that results are communicated rapidly to those who will put them into practice. The main results were presented to the International Liaison Committee on Resuscitation who have developed a draft Consensus on Science with Treatment Recommendations (CoSTR). https://costr.ilcor.org/document/vasopressors-in-adult-cardiac-arrest. The final CoSTR will be published in October 2019 which will inform resuscitation guidelines around the world. There is good evidence of penetration of these recommendations into clinical practice within 1-2 years of their publication. In addition, ILCOR run an on-going evidence evaluation process whereby new studies are identified and incorporated in to systematic reviews. The outputs from these reviews are shared with national resuscitation councils such as Resuscitation Council (UK) and from the basis for the development and revision of national guidelines. Results of the trial have also been communicated to the public via news articles. An infographic lay summary of the results has been sent to clinicians, participants and their legal representatives, and has been made available for download on the trial website. https://warwick.ac.uk/fac/sci/med/research/ctu/trials/critical/paramedic2/results/leaflet_patients.pdf A synthesis of current evidence on adrenaline, including the trial results has been published in Cochrane Library “Adrenaline and vasopressin for cardiac arrest (Review). (doi: 10.1002/14651858.CD003179.pub2) In addition “The effects of adrenaline in out of hospital cardiac arrest with shockable and non-shockable rhythms: Findings from the PACA and PARAMEDIC-2 randomised controlled trials” has been published in Resuscitation. (doi: 10.1016/j.resuscitation.2019.05.007)

Expected Benefits:

The trial is due to be completed by 31st July 2019 (NIHR have extended their support to this date) and the University expects the output from this trial will impact international resuscitation guidelines. There are established pathways through which advances in resuscitation science can be rapidly implemented into practice.

The University will ensure that the results of this trial are fed into the ILCOR evidence assessment and guideline process. ILCOR run a 5 yearly review of resuscitation science from which international CPR guidelines are created. There is good evidence of penetration of these guidelines into clinical practice within 1-2 years of their publication. In addition, ILCOR run an on-going evidence evaluation process whereby new studies are identified and incorporated in to systematic reviews. The outputs from these reviews are shared with national resuscitation councils such as Resuscitation Council (UK) and from the basis for the development and revision of national guidelines.

Guidelines used by the NHS are based on recommendations from the Resuscitation Council UK (RCUK) and are implemented within NHS Ambulance Trusts through the JRCALC. Key investigators on the trial also hold senior positions within the Resuscitation Council so they will be aware of the work and the results. It is likely that the trial findings will be presented at a RCUK national conference.

The applicant anticipates that the impact of this trial will be sufficient to determine future policy in this area.

Outputs:

The results of the PARAMEDIC2 trial have the potential to influence resuscitation guidelines worldwide, therefore trial results will be submitted for publication and disseminated as quickly as possible.

The University will submit the final trial results for publication in a high impact, open access peer reviewed journal such as The New England Journal of Medicine or The Lancet once data analysis is complete. Outputs will contain aggregate data only. Small numbers will be suppressed in line with the HES analysis guide. In addition, the University will present the results at scientific conferences, and to key stakeholders such as ambulance services (National Ambulance Service Medical Directors and Joint Royal College Ambulance Liaison Committee, (JRCALC)).

The trial will be reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The main publications will be the report to the funding body (NIHR Health Technology Assessment (HTA) Monograph) and a NIHR journal publication. In addition, the results will be presented at international conferences. This will ensure that the results are communicated rapidly to those who will put them into practice. The University will inform the ILCOR to ensure the results will be incorporated into national and international resuscitation guidelines via existing guideline development groups, which include several of the trial co-investigators.

The University will incorporate the findings of the trial into relevant review articles and ensure the findings of the trial are available through NHS Evidence. The University will work with their Marketing and Communication team to develop a strategy for communication with the media (television, radio, newspaper etc) to enhance communication of the trial results to patients / participants.

The University will produce a lay summary of the trial results with their public and patient involvement partners that include the trials management group (monthly meeting), the independent trial steering committee that meets on a bi-annual basis and the University Patient and Public Involvement (PPI) Group (UNTRAP) that meets annually. All groups have lay representation and participants from variety of backgrounds. This will be disseminated through their press officer, user groups, websites and INVOLVE database (an NIHR PPI network) to participants of the trial who indicated they wanted to know the results.

Processing:

PARAMEDIC2 patients (or their legal representatives) were approached for consent for further data collection once they had reached the hospital ward. At that point they could consent to, or opt out of, further data collection. This agreement relates to individuals where they have given consent.

No identifiers will be submitted and no data will be requested for patients who have declined consent for further data collection.

Data submitted to NHS Digital for linkage will include identifiable data (Forename, Surname, NHS number, address, postcode, date of birth and gender). A file will be submitted containing the details of the consented cohort only.

Data from NHS Digital will be downloaded via the secure web portal and stored in a PGP-encrypted file by a member of the trial team at University of Warwick. Only approved users who are members of the research team and substantive employees of the University of Warwick will have access to this folder. All individuals must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract i.e.: employees, agents and contractors of the Data Recipient who may have access to that data).

Fact of death and date of death will be used to determine whether patients enrolled in the trial survived up to 30 days (the primary outcome measure) and up to 12 months post cardiac arrest (secondary outcome measures). This will be combined with other data on the cardiac arrest e.g. treatments, neurological outcome and health status for the purposes of analysis, in order to answer the key trial question on the effectiveness of adrenaline. Data will be analysed using an anonymous Trial Identification number. Data will also be used to make sure a patient is alive before writing to them or their legal representative, to avoid causing any distress to relatives.

Hospital Episode Statistics data will be used be used as part of the health economic analysis. The HES data will be combined with other data collected during the trial (for example cardiac arrest data, patient questionnaire data) to determine the clinical and cost-effectiveness of adrenaline.

Data from NHS Digital will not be stored, processed or be in any other way accessible to any organisation except for the University of Warwick, as described in this agreement. No flow of data from NHS Digital is permitted to NICOR, ICNARC or any organisation other than the University of Warwick, and no flow of data into NHS Digital is permitted other than from the University of Warwick.

Warwick Clinical Trials Unit will also be requesting data from other hospital datasets (ICNARC and NICOR). Data from HES, ICNARC and NICOR will be combined via a 4-digit trial identification number. Patient identifiable details are already collected as part of the PARAMEDIC2 trial. However, the University of Warwick require identifiable data to be flowed back to the them following the ‘list clean’ to ensure they have a complete and accurate set of patient identifiers for further data linkage with other datasets (ICNARC and NICOR), as per the data flow diagram. It cannot be pseudo-anonymised data as this would result in sub-optimal data linkage with other hospital datasets. The University of Warwick will not link the data further, as only the data linkages described are permitted under this agreement.


PreFIT trial (Prevention of Falls Injury Trial) — DARS-NIC-302792-X4T6B

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, Health and Social Care Act 2012 – s261(2)(c)

Purposes: No (Academic)

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

When:DSA runs 2018-10-01 — 2021-09-30 2017.09 — 2017.11.

Access method: One-Off

Data-controller type: UNIVERSITY OF WARWICK

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Critical Care
  2. Hospital Episode Statistics Admitted Patient Care
  3. Hospital Episode Statistics Accident and Emergency
  4. Hospital Episode Statistics Outpatients
  5. Hospital Episode Statistics Accident and Emergency (HES A and E)
  6. Hospital Episode Statistics Admitted Patient Care (HES APC)
  7. Hospital Episode Statistics Critical Care (HES Critical Care)
  8. Hospital Episode Statistics Outpatients (HES OP)

Objectives:

University of Warwick Clinical Trials Unit is the lead organisation where the PreFIT trial main team and trial office is based. The Chief Investigator is now based at the University of Oxford but holds an honorary position at University of Warwick.

Other organisations involved in the trial include the University of Leeds Academic Unit of Health Economics. HES data will not be shared with the University of Leeds. Professor Bojke, Professor of Health Economics, holds an honorary contract with the University of Warwick and will provide the relevant statistical syntax for the economic analysis to be conducted by trial statisticians at the Warwick CTU.

In summary, the Warwick CTU were funded by the National Institute for Health Research Health Technology Assessment (NIHR) (HTA) to undertake a large complex intervention trial to investigate alternative strategies to prevent falls and fractures in older adults. Historically, the lead applicant was involved with earlier research that identified gaps in evidence; this in turn led to the HTA grant award to investigate alternative interventions to prevent falls: (1) advice alone, versus (2) exercise; versus (3) multifactorial falls prevention (MFFP) intervention in older adults. The aim of the trial is to identify which falls prevention intervention is the most clinical effective and cost-effective, on outcomes of falls and fractures, in adults aged over 70 years. The Pre-FIT trial is the largest trial ever conducted on community based fall prevention on outcomes of fractures. Further details on the background and rationale are provided below.

Falls and fractures are common and serious health problems for older people. The UK government recognised this problem and in 2004, in view of the importance of the problem, elected to develop a guideline through the National Institute of Clinical Excellence (NICE). The guideline was based on the available evidence at that time (up to 2003), which included a high quality review of all of the evidence conducted by the Cochrane Collaboration. Although the amount of evidence available was limited, the Cochrane systematic review concluded that MFFP services are likely to be effective. NICE took this recommendation forward, and undertook some preliminary economic evaluation. Following an evaluation for NICE, it was concluded that there was insufficient data available to determine cost-effectiveness of different options to treatment, including MFFP. NICE also commissioned an update the evidence and determine whether or not it would now be possible to generate economic models.

The University of Warwick undertook a rigorous review of the evidence, published in the British Medical Journal (Gates et al). The results of this were surprising, with the accumulation of evidence, it does suggest that MFFP interventions are considerably less effective than originally anticipated, and there is little evidence that fractures can be prevented with these treatments. Concurrently, researchers from New Zealand published a review which suggested that exercise may be just as effective as MFFP, but would be considerably cheaper. This information raised uncertainty, and the need to conduct a large trial to answer several questions which would inform NHS services.

Burden of falls
The NHS commits £34 million each year to multifactorial falls prevention interventions; these are thought to be conservative estimates. The cost of falls to the NHS and Personal Social Services (PSS) is estimated to be £908.9 million, with 63% of the costs incurred from falls in those aged over 75 years (Scuffham and Chaplin 2002). Although most falls result in no serious injury, approximately 5% of older people living in the community who fall annually experience a fracture (Rubenstein 2001; Tinetti 1988). The total annual cost of fall-related fractures to the NHS is £1.7 billion (Torgerson 2001). The recently updated Cochrane review of interventions to prevent falling in community dwelling older people has suggested that exercise reduces fall rates by approximately 25%, dependent on mode of exercise. Most of the clinical trials conducted to date do not capture fracture as an outcome; fracture is the biggest burden, both to the patient & NHS. Given the money that the NHS invests each year, it is crucial to investigate whether this is an efficient use of scarce resources, exercise may be a cheaper strategy.

This is a trial comparing alternative falls prevention interventions to prevent falls and fractures. Peripheral fractures, recorded within diagnosis codes in HES Inpatient, Critical Care, A&E and Outpatient datasets will be accepted as confirmed fracture. This is the primary outcome for the trial. Additional validation work will be conducted to compare ‘HES fractures’ to participant self-reported and fractures recorded in general practice. Other HES variables relating to hospital/episode duration (e.g. length of stay) will be used for economic analyses to determine the cost-effectiveness of alternative interventions. As this is a cohort of older adults aged over 70 years of age, we also require mortality data to accurately capture “time to event” outcomes, including fracture rates and falls rates over the duration of the study.

This is the final request for HES data for this clinical trial. We requested interim waves of HES data in 2012-4. We hold full HES data for all participants included in the pilot study (n=1801) and partial HES data for subset of main trial participants (N=8019). These data have been used to calculate number and site of fractures. This is the last PreFIT request for the final wave of HES data for the last three years’ worth of hospital data for those consenting within the relevant timeframe (thus HES years 2013/4, 2014/5 and 2015/6). For this final request, we have excluded those participants for whom we already hold full data (excluded pilot study participants). This request is for data within the three year consented time period, thus from 2014 – 2016 for 8019 participants.

For this final request, the study have restricted the request to the subset of main trial participants (excluding pilot study participants) to ensure the timing of individual signed participant consent falls within the approved three year timeline.

To summarise, the study team request final HES data to allow accurate analysis of the trial primary outcome, to generate time to event outcomes (time to first fall; time to fracture etc). The study are unable to report the main trial findings without these HES data.

Yielded Benefits:

Benefits to date include recruitment of a large representative cohort of older adults aged 70 to 101 years. This is one of the largest cohort studies of older adults in England and will provide valuable data on falls, fractures and health status over time. The study have published three papers relating to the trial to date and more publications are planned (two are currently under review). Early PreFIT falls results were presented at the European Falls Festival in July 2018, the Fragility Fracture Network in July 2018, and the British Geriatrics Society (BGS) Falls & Postural Stability meeting in September 2018. Further presentations are scheduled for events in November / December 2018. The study team have been in communication with Public Health England who are awaiting the final paper and Health Technology Assessment (HTA) report for the trial.

Expected Benefits:

The PreFIT trial findings will be considered by NICE when deciding whether to continue to recommend funding selected falls prevention activities; specifically whether to recommend exercise to prevent falls and fractures or whether resources are best directed at multifactorial strategies e.g. in those who are at greatest risk of falling. Trial findings will be incorporated into Cochrane systematic review updates. The majority of trials published to date have sample sizes of less than 200 participants. This trial has 9821 participants and will contribute a great deal of certainty with regards to findings.

Trial researchers were invited by Public Health England to present at a falls prevention event in 2016, to report on trial methods and to raise awareness of the near completion of the trial. PHE are awaiting the trial findings. We are also contacted regularly by consultant clinicians and falls prevention experts asking for updates on when the trial findings will be released.

The findings from PreFIT will undoubtedly inform clinical and public health policy decision making. This is the largest ever RCT of community dwelling older adults and will provide valuable information on whether NHS funding should be reallocated to other areas of care.

Falls are common in people aged over 70 years of age. Given the ageing population, the study expect the impact from this trial to be significant as will potentially affect a large number of older adults.

Outputs:

The following outputs will be produced:
1. An HTA monograph reporting the overall trial results to the funder (NIHR HTA). The monograph is due for submission in early 2018.
2. In parallel, the study intend to submit a number of peer-reviewed publications to leading medical journals. They expect the results of the trial to be of great interest to the academic community and anticipate publishing the ‘main’ findings in a leading journal eg. The Lancet, The New England Journal of Medicine (NEJM) or equivalent. There will be a number of related papers reporting subsidiary but clinically important research questions.
3. The study will publish the trial intervention manuals as open-access on the Warwick Research Archive Portal. The study have published the trial protocol paper (Bruce et al, BMJ Open 2016) and intervention papers are currently in press (BMC Geriatrics and Physiotherapy).
4. Trial findings will be summarised on the Warwick Clinical Trials Unit main website with further information within the PreFIT trial website: http://www2.warwick.ac.uk/fac/med/research/hscience/ctu/
http://www2.warwick.ac.uk/fac/med/research/hscience/ctu/trials/critical/prefit/patients/
5. Findings will be disseminated to AgeUK charity and to Public Health England.
6. Findings will be submitted to academic conferences, including geriatric care, physiotherapy and falls prevention conferences (e.g. British Society of Geriatrics; World Confederation for Physical Therapy).
7. Findings will be disseminated on social media via the Warwick Clinical Trials Unit Twitter page: @WarwickCTU. This website currently has 134 followers (March 2017). Findings will also be disseminated by the Warwick Medical School Twitter account: @warwickmed / N=3136 followers.

Processing:

Warwick Clinical Trials Unit will securely transfer a file of identifiers [NHS Number, Unique Trial/Study ID number, Date of Birth, and postcode] to NHS Digital. These identifiers will be provided over the SEFT system. The Unique Trial/Study ID is a 6 digit alphanumeric code and it is not possible to re-identify cohort members using this ID.

NHS Digital will use the customer IDs (WCTU Study ID) to link HES APC, CC, A&E and OP datasets.

NHS Digital will send the customer (WCTU) reports of record level HES Data to WCTU.

Warwick Clinical Trials Unit will store these data on a server at the University of Warwick which can only be accessed by a restricted number of personnel.

Professor Bojke, from University of Leeds Academic Unit of Health Economics will write the statistical code for economic analysis to be conducted at the Warwick CTU. No HES data will be transferred or shared with University of Leeds.

Data will only be accessed by individuals within the WCTU who have authorisation from the Chief Investigator to access the data for the purposes described, all of whom are substantive employees of the University of Warwick.

The Chief Investigator who is based at the University of Oxford will only have access to aggregated data will small numbers suppressed in line with the HES Analysis Guide.


No further linkage to any other datasets will be undertaken.

a) The data will be linked to the existing record level data. This is required to analyse fracture rates.
b) There will be no requirement or attempt to reidentify individuals from the data.
c) The data will not be made available to any third parties other than those specified except in the form of aggregated outputs with small numbers suppressed in line with the HES Analysis Guide.

The study request a HES data download for three years: 2013/4; 2014/5 and 2015/6. This covers the period for one year before trial recruitment to the end of follow-up for main trial participants only (n=8019). Participants from the pilot study are not included in this request. The HES data already held by the trial will be securely destroyed once the new HES data has been received from NHS Digital.

No geographical spread, this is for our trial cohort only, selected from five English regions. The trial have carefully selected the relevant variables for the purposes of analysis.

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)

Inequalities in Bowel Cancer referral rates in England — DARS-NIC-381887-X5W2S

Type of data: information not disclosed for TRE projects

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

Legal basis: Health and Social Care Act 2012, Approved researcher accreditation under section 39(4)(i) and 39(5) of the Statistical Registration Service Act 2007 , Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 – s261(2)(b)(ii)

Purposes: No (Academic)

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

When:DSA runs 2017-05-02 — 2020-01-01 2016.09 — 2016.11.

Access method: One-Off

Data-controller type: UNIVERSITY OF WARWICK

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Admitted Patient Care
  2. Hospital Episode Statistics Outpatients
  3. Office for National Statistics Mortality Data (linkable to HES)
  4. Civil Registration (Deaths) - Secondary Care Cut
  5. HES:Civil Registration (Deaths) bridge
  6. Civil Registrations of Death - Secondary Care Cut
  7. Hospital Episode Statistics Admitted Patient Care (HES APC)
  8. Hospital Episode Statistics Outpatients (HES OP)

Objectives:

Background:
There has been increasing concerns in recent years about differences in patient referral rates for suspected cancer across GPs. Each year there are nearly one million urgent GP referrals for suspected cancer (National Cancer Intelligence Network, 2014). In 2011, the rate of urgent referrals for suspected cancer in England ranged from 919.8 to 2957.4 per 100,000 populations. This 3.2 fold difference is evidence of a wide variation in cancer referral rates (Cancer Research UK, 2012). Socioeconomic factors and doctors characteristic have been shown to play a part in explaining variations in overall referral rates (O'Donnell, 2000). Overall GP referral rates for medical and surgical outpatient referrals are shown to be higher in high deprived areas, (Hippisley-Cox, Hardy, Pringle, Fielding, & Carlisle, 1997). This has not been tested for suspected bowel cancer referral rates. The characteristics that are expected to be associated with the referral rates are observed patients, local area characteristics, GP Practice characteristics and the incidence of bowel cancer in the particular GP area covered by the GP practice.

Objective for processing:
The main objective in processing the data is to carry out statistical analyses to explain observable variations in GP-practice referral rates for suspected bowel cancer and how this leads to positive diagnosis of cancer using patient, GP practice level characteristics and the local population characteristics. The research will try to explain how these observed variations has changed over time and how this has impacted on mortality. Another objective is to look at the effect of the Bowel Screening Program on the diagnosis of bowel cancer and the subsequent mortality.

A comprehensive analysis using mortality data will enable the modelling of survival durations after referrals.

The main product of this study will be the analysis carried out to answer three main questions:

1. What explains the observed variations in suspected bowel cancer referral rates? Is it possible to identify any particular groups of patients and particular areas that need to be targeted for efficient and effective referrals?

2. How have these observed variations changed over time and how this has impacted on mortality?

3. What has been the effect of the bowel screening program on the diagnosis of bowel cancer and the subsequent mortality?

The research papers written as part of this project will be included as evidence as part of a PhD thesis if they fall within the timeframe for submission.

Yielded Benefits:

The project was put on hold due to maternity leave of one of the researchers and hence there are no yielded benefits to date. The benefits listed from the study in section above are still expected to be achieved.

Expected Benefits:

This study aims to statistically model (i) variations in bowel cancer referral rates across GPs, and (ii) the survival rates, controlling for confounders.

There has been an increasing concern about the differences in the referral rates for patients suspected of cancer (http://www.rightcare.nhs.uk/downloads/Right_Care_Diagnostics_Atlas_hi-res.pdf.). Variations in referral rates are considered as a source of inefficiency in the primary care services. This project will aim to identify various sources (for example specific socio-economic factors) that contribute to observed variations in referral rates. This will help policies to be targeted to ensure that the relevant population receives the appropriate care and hence reduce inefficiencies in the delivery of care. Given the very wide dissemination strategy, this will help policies to be targeted at the right population to ensure that they receive timely and appropriate care, and hence increase their health and wellbeing.

Any beneficial change as a result of the outputs will be dependent on when the outcome of our research will be published. It will be ensured that all relevant bodies/organisations such as the NHS England, Public Health England, the Department of Health, Cancer Research UK, GPs and patients, involved in decision making with regard to bowel cancer diagnosis and treatment are informed about the research. For example, in 2010, Right Care working closely with NHS England, the Department of Health and the Public Health England, published for the first time the NHS Atlas of Variation in Health Care with the main aim to increase awareness regarding the variation existing in some clinical domains across different regions in England (http://www.rightcare.nhs.uk/atlas/qipp_nhsAtlas-LOW_261110c.pdf). The variation in cancer referral rates was considered very concerning and as they pointed out “Awareness is the first important step in identifying and addressing unwarranted variation” (Right Care 2010). By increasing awareness, they aimed to trigger the research for unwarranted variation and assess the value of the healthcare provided both to populations and to individuals. This research will contribute towards understanding part of the variation in cancer referral rates.

The methodology used will be very easily generalizable to incidences of other types of cancers too. The outputs will therefore be beneficial to other researchers who wish to look at similar issues in other diseases which show very wide variations in detection and treatment across different geographical areas.

Outputs:

Specific outputs expected, including target date:

The main product of this study will be the analysis carried out to answer the following important main questions:

1. What explains the observed variations in suspected bowel cancer referral rates? Is it possible to identify any particular groups of patients and particular areas that need to be targeted for efficient and effective referrals?

2. How have these observed variations changed over time and how this has impacted on mortality?

3. What has been the effect of the bowel screening program on the diagnosis of bowel cancer and the subsequent mortality?

As part of the analysis there will be various tables with the results from the estimation methodology employed to conduct the analysis. The results will be grouped to the lowest Primary Care Trust (PCT) level, such that no patient nor doctor information will be identifiable. In cases where the number of practices/GPs in a given PCT is small, PCT sharing boundaries will be grouped together so that anonymity of the doctors and patients will be preserved.

Expected outputs & dissemination activities:

The journal articles will be authored by the two users of the data.

The applicant will aim to publish the papers in general interest journal such as the British Medical Journal and specialist journal such as the Clinical Colorectal Cancer journal. These are peer-reviewed prestigious journals that reach a wide audience including health care professionals and individuals involved in policy making in the NHS. The statistical analysis to be carried out will be easily generalisable to other cancer incidences and hence the importance of also targeting of the general interest journals. The applicant will also ensure that the papers are made widely accessible through open-access policies of these journals to ensure that the results reach a wide audience including NHS staff who work with bowel cancer patients, policy makers and General Practitioners. Cancer Research UK will also be made aware of the research findings.

The findings from the project will also be presented at relevant national and international conferences to disseminate the results. Some of the conferences that are of particular relevance to this study include the Annual conference and exhibition by the National Association of Primary Care (NAPC) and the Annual Education, Research and Innovation Symposium by the Royal College of General Practitioners (RCGP). Both NAPC and RCGP aim to improve the quality of the primary care services as well as to bridge the gap between the primary and the secondary care. RCGP Symposium is considered as a ‘must attend’ event by General Practitioners, GP registrars and academics who want to learn more and potentially contribute in primary care service improvement. Additionally, the findings will also disseminated at The King's Fund events and the Cancer Research UK Cambridge Institute (CRUK CI) Seminar events. The participants at these conferences will in turn help to disseminate the results to wider audiences.

Non-technical executive summaries of the papers will be circulated to all the relevant organisations including those mentioned above. Warwick University has a very good media department which will ensure that all relevant results are publicised in an appropriate manner to reach the intended groups to achieve maximum benefits. If papers are accepted by the aforementioned journals, this it self will ensure that the results from this study reaches the right health professionals. Press-releases at the same time as publications will also ensure that the results get the maximum publicity.

The tentative target dates for conducting the study are as follows:

Months 0-3: The initial data cleaning is expected to take about 3 months.

Months 4-12: Cross-sectional analysis of variations in observed patterns of referral rates and writing of the paper. A paper for a general interest medical journal such as the British Medical Journal, or a specialist interest journal such as the Clinical Colorectal Cancer journal.

Months 9-36: Longitudinal analysis of variations, modelling using survival analysis, writing of the paper. A paper for a general interest medical journal such as the British Medical Journal, or a specialist interest journal such as the Clinical Colorectal Cancer journal.

All outputs will have small numbers suppressed in line with the HES analysis guide.

Processing:

Data creation for analyses
i) The HES data extract will provide the Lower super Output Area (LSOA) identifiers which will be used to merge the local area population characteristics from the Census data with the HES information. This is crucial for the statistical analysis as this will enable the analysis to account for confounders and eliminate the bias in the estimation of the statistical models.

ii) “The Quality Outcome Framework (QOF) is a voluntary annual reward and incentive programme for all GP surgeries in England, detailing practice achievement results. It is not about performance management but resourcing and then rewarding good practice.” See http://www.hscic.gov.uk/qof. QOF data provides some information on GP practice characteristics such as, the overall demographics of the pool of registered patients like the size of registered patients, their age group, etc. It also provides some information about the prevalence of different type of diseases like Cancer, Diabetes, Depression, Heart Disease, etc. But none of the information in QOF data are sensitive and these are freely available to retrieve from the HSCIC’s website.

Matching of the QOF data to HES will enable the analysis to account for confounders such as the health of the patients attached to the GP practice. This will enable the applicant to model the probability of the referral leading to a confirmed diagnosis of bowel cancer. In summary, the HES data will be merged with the local patient characteristics that can be extracted from the QOF data and also the Census data at the LSOA level. This is crucial for valid statistical analysis.

Statistical analyses

This has three parts:

(1) Starting with a linear model and cross-sectional data, first analysis with look at the effect of observed patients and GP Practice characteristics on suspected bowel cancer referral rates. All referrals will be grouped into three categories; immediate, urgent and non-urgent, and then standardized and adjusted for demographic and population characteristics obtained from the LOSAs. The results from this estimation will be used to test the hypothesis of whether the observed patients and GP Practice characteristics have a significant effect on explaining the variations in referral rates for suspected bowel cancer.

(2) The second stage of the analysis will use the entire longitudinal dataset from 2003 to 2013 and panel data analysis to model the changes in behaviour through time. In addition, the analysis will be used to estimate the effect of the bowel screening program (introduced in 2006) on the observed patterns of referrals.

(3) The final part of the project will use survival analysis to model the probability of death from bowel cancer conditioning on the type of referral and the characteristics of the patient and the GP practice.

None of the processed data will be shared with any third party nor will they be used for commercial purposes or for marketing purposes. All individuals with access to the data are employees of the University of Warwick.

MR1376 - OHCAO (Out of Hospital Cardiac Arrest Outcomes) — DARS-NIC-351810-N3G6N

Type of data: information not disclosed for TRE projects

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

Legal basis: Section 251 approval is in place for the flow of identifiable data, Health and Social Care Act 2012 – s261(7)

Purposes: No (Academic)

Sensitive: Non Sensitive, and Sensitive

When:DSA runs 2017-01-25 — 2023-06-30 2016.04 — 2016.08.

Access method: Ongoing, One-Off

Data-controller type: UNIVERSITY OF WARWICK

Sublicensing allowed: No

Datasets:

  1. MRIS - List Cleaning Report
  2. Civil Registration - Deaths
  3. Demographics
  4. Civil Registrations of Death

Objectives:

The British Heart Foundation and the Resuscitation Council UK have funded the development of a database of Out of Hospital Cardiac Arrests (OHCA) attended by an NHS ambulance emergency response. The project is called Epidemiology and Outcome from Out of Hospital Cardiac Arrest (OHCAO). It is run by the Emergency and Critical Care Team at the Warwick Clinical Trials Unit, University of Warwick. Data is collected by Ambulance Service Trusts and returned to a secure database run by the team.
The project aims to establish the feasibility of developing and sustaining a national data base. This includes identifying the optimal process for case identification and outcome verification following OCHA. The project also aims to report on the epidemiology and outcome following OHCA. Survival is a key outcome.
This application concerns the part of the OHCAO project, which aims to standardise and streamline the process for outcome verification for patients who did not die in the care of the ambulance services, to determine whether or not these survivors died subsequently. Initially a subset of data collected for the OHCAO project will be used to assess the feasibility of the data linkage process.
Previous work by the team (Paramedic Study: NIHR HTA - 07/37/69) found that collecting data on mortality after a patient was admitted to hospital was challenging for the Ambulance Services. The ONS data on mortality is a single, accurate and reliable source or mortality, so the OCHAO project would like to establish the feasibility of linking the OHCAO project data set with ONS data.
Given acknowledged difficulties for Ambulance Services to collect patients' NHS numbers, which are needed to make the link to the ONS data set, an objective is to assess the feasibility of improving the match rate of OHCAO dataset with the ONS and assess its accuracy through HSCIC's list cleaning service. The objectives of this application are therefore to use a randomly selected 10% sample of the OCHAO data collected in 2014 to:
1. Assess the completeness and quality of variables used for case identification, collected by the Ambulance Services, through the HSCIC list cleaning service.
2. Assess the quality and completeness of mortality data collected by the Ambulance Services through linkage with ONS mortality data,
3. Assess whether and by how much the HSCIC list cleaning will improve the match rate of the OHCAO data for data linkage to ONS mortality data
4. Use the resulting data set to analyse 30-day survival from OHCA

Yielded Benefits:

The success of and need for the OHCAO registry is highlighted in the NHS England Long Term Plan. Being able to provide the best quality survival data has helped inform NHS England policy. The registry will also be able to monitor progress toward the target of saving an additional 4,000 lives a year by 2028. The Annual Epidemiology reports provide valuable information to ambulance services allowing bench marking with the national average. The reports are also used in planning their services and resources towards quality improvement initiatives. The impact of these initiatives can be measured using OHCAO registry data. The OHCAO research registry is a valued research tool used by the clinical and academic community. Data sharing applications with internal and external researchers continue to increase each year. Use of the data by external researchers will result in increased information to contribute to the above aims.

Expected Benefits:

By establishing a national Out of Hospital Cardiac Arrest Outcomes database there is potential in the future for considerable patient benefit. For example, Ambulance Services may use data to assess the impact of service improvement initiatives or researchers may use the data to assess the impact of interventions designed to improve survival, or understand the epidemiology of OHCA providing information about variation in outcome in the UK. This sort of understanding could help target interventions to improve patient outcomes. However, at this stage of the project, the focus is on developing and testing the best ways to collect the most accurate and reliable data for such a registry. The key expected benefits of this development phase will influence the next steps for establishing the OCHAO database.
The results will inform the OCHAO team in making decisions about improving data completeness and quality for the remainder of the funding period (October 2018). It will also inform decisions about the feasibility of future data linkage work and the potential and value of extending this process to the whole database.
The report to the funders will feed into their decision making about the feasibility of the data base and potential uses of the data for their future work. There are other elements of the OCHAO Project that will contribute to this decision-making. However this list cleaning and data linkage project will provide specific information about data collection and maximising data completeness and quality.
The report to the Ambulance Services will provide feedback and inform decisions about data collection, data completeness and data quality for the remainder of the OCHAO project (October 2018).
The paper in the peer-reviewed journal will provide knowledge to the research community about the methods of this data cleaning and linkage project and the survival outcomes for the subset of patients from the OCHAO database. It will inform researchers of the potential of the OCHAO database as an outcome database for future research to improve patient outcomes. Target date for publication: December 2017.

Outputs:

This application relates to a 10% sample of one year of data held on the OHCAO database and it's specific outputs will be
1. A report for the funders on the outcomes of this data linkage project this would contain details on how they link the mortality data to see if there is an increase to individuals who have out of hospital cardiac arrest. Target date April 2016
2. A report to the ambulance services. This would contain details of the 12 ambulance services across the country and within the report it would provide individual reports to showing how out of hospital cardiac arrests is linked to mortality for that region covered by that service linking the ambulance service within that region to cardiac outcomes in that area. Target date April 2016.
3. A paper in a peer reviewed journal. This is a high impact journal covering the UK detailing how mortality caused by out of hospital cardiac arrests are linked and survival rates Target publication date December 2017
All reports and papers will only contain data that is anonymised and aggregated in line with the HES Analysis Guidelines.
It is the intention to report findings about the feasibility of linking the OCHAO data set with HSCIC/ONS data and the implications for expanding linkage to other HSCIC held data. It is also planned to report the results of survival analysis on the 10% sample.

Processing:

The process of obtaining and using the data provided by HSCIC and the ONS will follow several steps.
1. OHCAO team will provide a 10% randomly selected sub-set of data held in the OHCAO database for the year 01/01/2014. to 31/12/2014 to HSCIC, via the HSCIC managed secure transfer system, which will contain the following variables:
a. Patient forename and surname
b. NHS Number
c. Post Code
d. Date of birth
2. HSCIC will provide a list cleaning service which will check the accuracy of the OHCAO data set and provide missing data where possible on the following variables:
a. Hospital Number
b. Post code
c. Date of birth
d. Date of death
e. Surname
f. Forename
3. HSCIC will link this data set to the ONS mortality data set, specifically to the variable "date of death". HSCIC will provide the “date of death” to OHCAO to allow OHCAO to calculate survival rates. OHCAO requires information on deaths from 01/01/2014 until 31/01/2015. This will be used to produce an outcome of 30-day survival from the work. For this reason, because OHCAO data set provided ends at the end of December 2014, mortality data is requested covering the period up to the end of January 2015. This will allow calculation of 30-day survival for any patients who had an arrest up to and including 31/12/2014.
4. HSCIC will securely transfer the list-cleaned data set and the linked date of death from the ONS to the OHCAO project team at Warwick University.
5. The data set will be held securely. The University’s network is protected by Cisco designed infrastructure incorporating firewalls, VLANS (used to secure distinct areas of the university’s campus) and Intrusion Detection Software to alert the Network Services team of potential risks. The Network Services team uses a comprehensive system for logging network activity. All servers are located in a purpose built data centre protected by a strictly policed access control system and CCTV surveillance. Occasional visitors/contractors are always escorted by an appropriate member of staff. Access to all systems requires a user name and password. Access to the database application requires an additional security role to be assigned to lock down features of the application to only those users who require them e.g. access to personally identifiable data.
6. Only the individuals with Approved Researcher accreditation will have access to the raw data.
7. The dataset will be used to establish the accuracy of the OHACO data base variables for NHS Number, Post Code, Date of Birth and Date of Death and used to update the database where necessary. Decisions will be taken on what are the minimum identifiers needed for data linkage and identifiers that are not required will be destroyed. For example, if it transpires that the NHS number and Date of Birth are sufficient for data collection by the ambulance services then the project will ask the ambulance service to stop collecting forename and surname in the future.
8. The data set will be analysed to investigate the 30-day survival rates for patients.