Greater Manchester Rapid Service Evaluation Team: REVAL-GM and Manchester-Leeds Collaborative National Evaluation Team: Rose-NET

The University of Manchester requires access to NHS England data for the purpose of the following programmes of work: Greater Manchester Rapid Service Evaluation Team: REVAL-GM; and Manchester-Leeds Collaborative Evaluation Team (Rose-NET).

The REVAL and Rose-NET teams are asked to evaluate relate to topics that are deemed as high priority by health decision-makers at the NIHR Health and Social Care Delivery Research Programme (HSDR). The REVAL and Rose-NET teams conduct these rapid and reactive evaluations of health and care service innovations, in close partnership with those who deliver, manage and use these services. The REVAL and Rose-NET team do not choose topics for evaluation.

The REVAL and Rose-NET teams use a systematic, collaborative approach based on careful planning and clear communication and will:

1. Evaluate innovations that are important to the NHS as identified by the funder, NIHR;

2. Evaluate these innovations using appropriate methods. This might involve talking to patients and staff, collecting new data and using data the NHS already collects;

3. Share findings as they emerge in ways that make sure they have impact and are useful to health service providers and patients.

Over a 5-year period, the NIHR is expected to allocated approximately 10 innovations for the REVAL team to evaluate and approximately 4 innovations for the Rose-NET team to evaluate.

REVAL projects would be expected to complete within 6 to 9 months. Rose-NET projects would be expected to take longer.

The data will only be used by the REVAL and Rose-NET teams to evaluate the following factors in relation to an innovation within the NHS:

o Does this innovation improve the way the NHS work?

o Does this innovation offer value for money compared with alternatives?

o Is this innovation acceptable to the people who use it?

o Which elements of the innovation are crucial to its success?

o Does this innovation improve access for those in most need?

All evaluations will conform to the following scope:

i. The subject of the evaluation will be a health or care provider (or group of health and/or care providers) which has/have adopted a new way of working which differs to those currently adopted by the health system - i.e. an 'innovation'. Health or care providers may be NHS Trusts, Local Authorities or, for example, a group of district nurses. The innovation may be the use of new technology or a financial and/or service model redesign.

ii. The evaluations will attempt to determine whether there were any detectable changes in the metrics over time that might be associated with the introduction of the innovation. This would be done using a variety of techniques such as comparing metrics for the health care provider(s) pre and post-introduction of the innovation or comparing the metrics of the health care provider(s) which adopted the innovation with health care provider(s) where the innovation is not in use.

iii. Alongside this quantitative analysis, local qualitative information gathering and analysis would be carried out to understand how and why the innovations might have had a particular impact in those local health economies.

The University of Manchester has established a Data Management and Approval Group which will approve all projects requiring data from NHS England.

The Data Management and Approval Group and the Applicant Lead* will ensure that any proposed use of Data conforms to the agreed criteria above, with appropriate input from the University of Manchester Data Protection Officer (DPO).

* The Applicant Lead refers to a member of the University of Manchester REVAL or Rose-NET team taking ownership of the individual programme of work.

The Data Access process will be as follows:

i. The REVAL or Rose-NET team are assigned projects by NIHR.

ii. REVAL Co-leads (Professor of Applied Health Research and Senior Lecturer in Implementation science) or Rose-NET Co-leads (Professor of Health Services Research and Reader in Health Economics) discuss each project with key stakeholders, including any relevant datasets available to the team including routinely collected data (e.g. HES, CSDS, MSDS).

iii. An outline protocol is developed including research questions to address as part of the evaluation. Further discussions with key stakeholders and the wider REVAL or Rose-NET team supports the development of the full protocol including methods to be used which may involve the use of routinely collected data.

iv. Projects are assigned to members of the REVAL or ROSE-NET team, who form a specific project team. The project team discuss the project on a weekly basis with the REVAL co-leads, or a fortnightly basis with the Rose-NET co-leads. As a part of this a separate protocol will be developed in conjunction with the wider REVAL or Rose-NET team including statisticians and health economists clarifying the analysis plan and how the requested data will be used in the project.

v. Once the data analysis plan (protocol) has been developed the project team will complete a data request form to include:

a. Names of researchers who will access the Data

b. A brief description and aim of the project

c. What dataset(s) will be required and what justification for requiring these datasets

d. Which data (informed by the data dictionary) will be required and what justification for requiring these. This might include;

- years of data

- size of case and control cohorts

- inclusion and exclusion criteria (e.g. use of specific diagnostic codes)

- approaches to matching, if being used

vi. The data request form will be reviewed and approved by the Data Management and Approval Group.

vii. Where appropriate REVAL or Rose-NET researcher(s) will apply for ethical approval from the University of Manchester.

viii. Researchers will also be required to develop a Data Management Plan.

Prior to receipt of data the researcher(s) will be required to complete an information governance (IG) access form confirming the following University of Manchester training and policies have been completed:

· The University of Manchester’s Data Protection and Cyber Security training

· information security

· Minimum Controls Technical Security Standard

· Information security classification and secure information handling

· Data Protection

· Reporting data protection incidents

· Records Management

· Acceptable Use Policy

· Acceptable use of IT facilities and services – procedure for staff

· Authentication Technical Security Standards

· Password Technical Security Standards

Each REVAL and Rose-NET project involving access to routinely collected data (e.g. HES, CSDS, MSDS) will therefore require a dedicated protocol, data request form (including data dictionary items) and data management plan. In addition, each researcher involved in the project will need to complete an IG access form.

Once an evaluation topic has been received from NIHR and an initial scoping exercise performed, a detailed research protocol will be developed by the REVAL or Rose-NET team. The protocol outlines the design and methods proposed to answer the research questions including the plans for data processing, the approach to Patient Public Involvement (PPI), ethical issues, data and information management, risk management and dissemination of findings. The protocol will be reviewed by independent experts in healthcare organisations and management, project stakeholders, NIHR and patient community involvement and engagement (PCIE) representatives. This stage of review will aim to advise the REVAL or Rose-NET team of any shortcomings in the proposed work, or of additional research questions the REVAL or Rose-NET team might find valuable to address. In developing the evaluation protocols the REVAL and Rose-NET programme leads will ensure that any proposed use of the datasets conforms to the agreed scope above.

Each project lead will ensure that:

i. projects have clearly defined objectives and analysis plans;

ii. the use of the data is necessary and proportionate to the purpose of the project - this will include consideration of the necessity for the use of each dataset; the number of years of data; the size of any cohort or control cohorts derived from the data, and the inclusion and exclusion criteria (such as presence of specific diagnostic or procedure codes);

iii. appropriate safeguards are in place to protect confidentiality; minimising risks of re-identification and use of excessive data beyond necessity

iv. individual or individuals within the REVAL and Rose-NET teams who will carry out the project will be bound by an analysis plan detailing what data is permitted for use in the project and how it shall be processed. The REVAL and Rose-NET teams aim to start each project (or sub-project workstream, as appropriate) with an assessment of the data necessary for analysis, and the anticipated analytical steps.

REVAL and Rose-NET do not choose which projects to evaluate but are responsive to requests from NIHR HSDR to evaluate those projects they have identified as high priority. However, REVAL and Rose-NET have independent Stakeholder Advisory Groups and input from Patient and Community Involvement and Engagement (PCIE).

The Stakeholder Advisory Groups (SAGs) draw together expert leaders from across relevant sectors, including NIHR, and an independent Chair.

The SAGs will perform two main functions:

1) Programme oversight: the SAGs will meet bi-annually to review programme and project progress, proposing amendments if appropriate. Recommendations will be recorded and shared with NIHR.

2) Ongoing advice and support: the SAG members will advise on: horizon scanning; current innovations and who to contact in relation to these; additional sites that are implementing innovations that REVAL-GM or Rose-NET are evaluating; and on effective dissemination of findings.

PCIE involves service users, carers, patients and members of the public who make for a stronger rapid/reactive evaluation team, to ensure more focused research and more accessible and user-friendly outputs. The REVAL and Rose-NET teams worked with patient and public partners on the initial bids, and plans to involve people throughout, to ensure the work benefits from their experience of health/social care services, understanding of patient, public and service user perspectives and the successful engagement of these users.

REVAL and Rose-NET place co-production at the heart of each evaluation. To facilitate rapid evaluation, University of Manchester work with a group of link PCIE team members to construct project-specific iterative PCIE co-production plans reflecting the project requirements. This includes potential formats for engagement, such as workshops, individual discussion, surveys, and stakeholder mix at sessions. University of Manchester draw on an established framework for experience-based co-design, combining whole-group introductory and review events, and small group parallel co-production sessions to optimise study efficiency and timelines.

The team will develop introductory material to introduce the topic and work with PCIE link members to refine this as required. University of Manchester engage with relevant PCIE stakeholders at organisational and individual levels, combining established networks and bespoke orientation events. University of Manchester plan to integrate findings into the project development work and ensure ongoing evaluation of all PCIE activities using multiple methods including informal discussions, structured feedback and Equality, Diversity and Inclusion and auditing.

The number and frequency of uses of the data per typical year will be 3-4 depending on the specific details of the individual research projects and whether the use of data is necessary and proportionate to the purpose of the project.

The following NHS England data will be accessed:

• Hospital Episode Statistics (Admitted Patient Care, Accident & Emergency and Outpatients) - necessary because this data could be used to calculate relevant metrics that those implementing the technology would be seeking to affect, for example, readmissions to hospital for the targeted groups in those areas

• Emergency Care Data Set (ECDS) – necessary as this data could be used to calculate relevant metrics that those implementing the technology would be seeking to affect, for example, emergency care admissions for particular patient groups

• Community Services Data Set (CSDS) – necessary because this will enable the REVAL and Rose-NET teams to investigate areas such as displacement of activity where trusts may be successfully reducing re-attendances by displacing activity into other services such as community care

• Maternity Services Data Set V2 (MSDS) – necessary because one of the current projects relates to the enhanced maternity continuity of carer and access to this dataset would enable University of Manchester to look at whether teams are providing care to their intended target groups (lowest decile of deprivation) and in the longer term outcomes from the new service innovation.

Due to the variable nature of the evaluations, it is not possible to detail in advance exactly what data variables will be required. The University of Manchester has identified the above datasets as most likely to be required to support a rolling programme of evaluations and the broad range of variables per dataset reflects the need for a versatile dataset capable of use for multiple purposes.

The level of the data will be:

• Pseudonymised

The data will be minimised as follows:

• Limited to data between 2017/18 and the latest available year with annual refreshes as they become available.

• For each evaluation, the project lead and Data Management and Approval Group will ensure that the use of the data is necessary and proportionate to the purpose of the project.

• For each evaluation data will be minimised through selection of specific years and filtered by demographic characteristics and diagnostic codes as appropriate this will be documented in the data access form

The University of Manchester have been broad in specifying data requirements as this approach will give University of Manchester the flexibility required to undertake rapid and reactive evaluations that come from the NIHR HSDR in a timely manner. University of Manchester will take a broad approach because they are not able to predict what evaluations the REVAL and Rose-NET team will be allocated and what data will be required. All REVAL and Rose-NET evaluations have a national focus.

The University of Manchester will not use the Data outside of a stringently controlled process. Data will be held centrally and the Data Management and Approval Group will ensure that data for each individual project is necessary and proportionate for each individual project. Access to Data will be minimised by a nominated member of the REVAL/Rose-NET programme in the Data Management and Approval Group so that individual researchers will only access data relevant to each specific project.

The University of Manchester is the sponsor and the controller as the organisation responsible for ensuring that the data will only be processed for the purpose described above.

NIHR Health Services and Delivery Research (HS&DR) programme has commissioned the University of Manchester to undertake the work. NIHR does not specify what data are required to deliver the work nor how the data shall be processed to achieve that purpose. Such decisions are taken by University of Manchester.

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. Specifically, the data will be used to track changes in health care activity over time enabling analysis of the impact of changes in health services; conduct detailed analysis of particular health events used to identify particular issues with quality of care; and study variation between hospitals or areas in use of services which can identify populations where there are gaps in care, and also areas delivering high quality care from which the NHS can learn more widely.

The funding is provided by NIHR HS&DR Programme. The funding is specifically for the work described.

The University of Manchester is the sole organisation processing the data. No other organisations will process the data.

Two other organisations are involved in the wider Rose-NET programme (University of Leeds, and Vocal), but will have no access to the data. University of Leeds are responsible for the qualitative research elements of Rose-NET. VOCAL is responsible for the patient and public involvement and engagement activities.

All final decisions regarding the means and purpose for which the personal data are being processed will be made by the Rose-NET Co-leads who are employed at the University of Manchester. As such the University of Manchester is the sole data controller.

Data will only be accessed by substantive employees of the University of Manchester.

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

NHS England will provide the relevant records from the HES, ECDS, CSDS and MSDS datasets to University of Manchester, The Data will contain no direct identifying data items. The Data will be pseudonymised and individuals cannot be re-identified.

The Data will not be transferred to any other location.

The nominated member of the REVAL/RoseNET programme in the Data Management and Approval Group at the University of Manchester will extract a subset of the Data comprised of relevant data and make this available to other researchers within the REVAL and Rose-NET team within the University of Manchester where appropriate.

The Data will be stored on servers at University of Manchester and Equinix. Equinix only provides the building and cooling and does not have access to the Data.

University of Manchester uses off-site back-up services provided by Ascendas Reit.

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

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 (as further restricted elsewhere within the DSA if so done) stated within this DSA;

- Access controls granting users the minimum level of access required are in place;

- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;

- Multifactor authentication (MFA) is required for remote access;

- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;

- All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA.

The data will not leave England at any time.

Access is restricted to substantive employees of the University of Manchester who have authorisation from the Data Management and Approval Group.

The Principal investigator will always be a University of Manchester substantive employee. Access is restricted to individuals within the REVAL and Rose-NET teams of The University of Manchester who have authorisation from the Data Management and Approval Group. .

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

The Data will not be linked with any other data.

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

The REVAL and Rose-NET teams are committed to disseminating evaluation findings to appropriate evidence users in a timely way, and in a format that meets user needs. All varied outputs will be shaped around the audience, what they need to know and how quickly they need to know it.

For formative work, feedback will often only go to policy and organisational staff in the form of reports, meeting papers and presentations. Timeliness is of the essence to ensure that results can be used to inform service delivery and decisions around this.

The University of Manchester will also ensure they feedback to PCIE representatives in appropriate ways. Across projects the University of Manchester have conducted previously, they have done this using more innovative approaches, such as animations and workshops, as well as using more standard approaches including infographics and lay summaries.

To cascade more summative findings to appropriate audiences, the University of Manchester will write and submit journal papers. All work will be logged on the Open Science Framework to ensure transparency.

Work will also be presented at national and international academic conferences. Where relevant, the REVAL and Rose-NET teams will work with the University of Manchester Communication and Marketing Team.

REVAL has a communications and dissemination strategy which will be used for each project:

o Identify the audience: who needs to know?

o Set a timetable for dissemination outputs: weeks, not months

o Decide on appropriate media and form of communications

o Ensure written outputs are as simple as possible

o Provide context and other evidence relevant to each evaluation.

The REVAL team also have a webpage (https://sites.manchester.ac.uk/reval/) devoted to the REVAL programme.

Rose-NET also has a communications and dissemination strategy which will be used for each project. This strategy is based on that of REVAL, but adapted to account for the longer-term nature of the Rose-NET evaluations:

• Identify, assess and prioritise stakeholders

• Establish timelines for communication and engagement activities

• Establish regular communication channels with stakeholders

• Define and refine models of communication

• Develop clear and targeted messages

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 may be communicated to relevant recipients through the following dissemination channels:

• Journals

• Workshops involving, for example, PCIE representatives

• Webinars open to interested parties

• Social media

• Public reports

• Direct bilateral engagement with NIHR and NHS-England stakeholders

• Briefing documents provided to NIHR and NHS-England stakeholders

• Co-hosted events where appropriate

• Open source frameworks

• Public events such as national and international conferences

• Posters at national and international conferences

• Patient Information leaflets

• Press/media engagement

• Public promotion of the research

• Participant newsletters

• Reports aimed at participants/patients

In terms of target output dates, these will be set for each project as part of the project planning and milestone setting. For REVAL some requirements will be rapid, with feedback being required in terms of weeks, and some outputs will be expected nearer to the project's end. For Rose-NET the anticipated timelines would be:

o Innovation 1: Interim evaluation results Dec 2026, final evaluation results Dec 2027

o Innovation 2: Interim evaluation results Dec 2027, final evaluation results Dec 2028

o Innovation 3: Interim evaluation results Dec 2028, final evaluation results Dec 2029

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

The use of the Data could:

• help the system to better understand the health and care needs of populations.

• lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.

• advance understanding of regional and national trends in health and social care needs.

• advance understanding of the need for, or effectiveness of, preventative health and care measures for particular populations or conditions such as obesity and diabetes.

• inform planning health services and programmes, for example to improve equity of access, experience and outcomes.

• inform decisions on how to effectively allocate and evaluate funding according to health needs.

• provide a mechanism for checking the quality of care. This could include identifying areas of good practice to learn from, or areas of poorer practice which need to be addressed.

• support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work).

The benefits of the work may be seen in terms of decisions made by healthcare commissioners and providers when thinking about the types of services needed to deliver benefits to patients, as well as by policymakers.

The wider REVAL and Rose-NET teams have extensive networks in health and care sectors and an impressive track record in co-producing meaningful research findings and using a wide range of approaches to reach and influence decision-makers.

The REVAL and Rose-NET teams will develop a communications and dissemination strategy for the overall programme as well as for each project.

REVAL and Rose-NET will aim to produce evidence on how to organise and deliver services to best meet patient need. The evidence produced will facilitate improvements in the organisation and provision of health services, which will ultimately result in improved access and outcomes for patients.

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

There are several benefits that are expected to arise from the University of Manchester’s use of the Data and that expectation is supported by work University of Manchester has previously undertaken.

Informing service delivery in the NHS:

REVAL and Rose-NET evaluations are co-produced with the health and care system. Having access to timely HES and other datasets will facilitate rapid evaluations of changes in service delivery in health and social care, enabling evaluations to inform local, regional, and national commissioning decisions and adaptations in service delivery, thus helping to inform service delivery in the NHS.

Informing policy:

As a team REVAL and Rose-NET have a strong track record of sharing learning and insights throughout the research process and in ways that have directly informed the commissioning and delivery of services, locally, regionally and nationally. The team will harness the strategic communications expertise at the University of Manchester and work with Policy@Manchester. They have established working relationships with local, national, and international policy-relevant organisations, and have successfully delivered meaningful policy engagement, including high- level civil service briefings, select committee appearances, combined/regional authority workshops, and bespoke Westminster events.

The University of Manchester REVAL and Rose-NET teams are also active members of the Northern Health Science Alliance which brings together ten universities, ten research-intensive NHS Trusts and four Academic Health Science Networks and is mandated to improve the health and wealth of the North of England. The team harness this network to help ensure University of Manchester are maximising the potential for regional and national policy impact.

Gaining insights into equity in health and social care:

Record-level data enables evaluations to understand the impacts of changes on protected characteristics, informing whether service changes facilitate adherence to the public sector Equality Act (and NHS Constitution). It allows the team to evaluate equity in access across various population groups, and equity in completing the intervention, if relevant. In addition, record-level data enables a more accurate evaluation of service changes, enabling adjustment for potentially confounding factors, that in their absence, may result in the advocation of service changes that reinforce or widen inequalities in health and care.

To date the number of REVAL requests requiring access to NHS England data have been relatively small. Currently we have one project which is using HES data.

This project aims to evaluate a pilot scheme of hyperacute units for patients with sickle cell disease.

Using HES APC from 2017/18 to 2023/24 we will identify a cohort of patients with a sickle cell related admission using ICD10 diagnostic codes D57* or R50.81 (fever presenting with conditions classified elsewhere). The introduction of hyperacute units will primarily affect patients with sickle cell disease, however, it may also benefit patients presenting with thalassaemia so this group of patients will also be identified using the ICD10 code D56*.

All hospital activity (HES APC, HES OP, HES A&E) for this cohort will be extracted.

Descriptive analysis will compare service use for hospitals with these units, before and after their introduction. Service use for hospitals with and without hyperacute units (control group) will also be compared one year prior to introduction of hyperacute units. Measures of service use will include:

• counts of admissions of people with sickle cell disease and thalassaemia

• length of stay of hospital admission

• time between discharge and next hospital service use

• for the A&E visit leading to the sickle cell related admission the time for assessment, treatment and overall waiting times will be explored