A multicentre pilot cluster randomised controlled trial evaluating an intervention to reduce sedentary behaviour in stroke survivors incorporating an embedded process evaluation

University of Leeds Clinical Trials Unit (CTRU) and Bradford Teaching Hospitals NHS Foundation Trust (BTHFT) require access to NHS England data for the purpose of the following research project: RECREATE -

A multicentre pilot cluster randomised controlled trial evaluating an intervention to reduce sedentary behaviour in stroke survivors incorporating an embedded process evaluation

The following is a summary of the aims of the research project provided by the University of Leeds and BTHFT:

Sedentary behaviour is closely associated with increased risk of cardiovascular mortality, cancer, incidence of cardiovascular disease, and type two diabetes. Stroke survivors are more sedentary than healthy age-matched controls. Increased sedentary behaviour in this high-risk population may result in a decline in physical functioning and quality of life. To address the challenge of reducing sedentary behaviour after stroke an intervention (‘Get Set Go’) was developed. RECREATE is a multi-centre pilot cluster randomised controlled trial evaluating the ‘Get Set Go’ intervention to reduce sedentary behaviour in stroke survivors.

RECREATE aims to evaluate ‘Get Set Go’ which is an evidence-based and clinically feasible intervention to reduce/ break up sedentary behaviour in stroke survivors. The primary objective is to preliminary explore whether the intervention has the potential to improve the ability to complete Extended Activities of Daily Living (EADLs) in the first year after stroke. Secondary objective: to explore whether the intervention is likely to reduce daily sedentary time.

This data sharing agreement is intended to provide data on secondary care services received by the patients enrolled in the UK in order to allow quantification of the overall cost of each patient’s care. Stroke survivors’ utilization of healthcare and societal resources is substantial and studies attempting to map resource use utilization are challenged by the difficulty of achieving a statistically meaningful follow-up rate. RECREATE offers an opportunity to gain an understanding of the optimum approach to the collection of service use data to undertake economic evaluations in stroke. Therefore, the objectives of the study are to address the following questions:

1. What is the difference in cost of using data from self-report and data from routinely collected hospital episode statistics (HES) data?

2. What is the impact on cost-effectiveness estimates if the economic evaluation is based on self-report versus HES data?

3. What is the agreement level between estimates of hospital services utilization based on HES versus self-reported data?

4. What additional information does a longer term (24m versus 12m versus 6m) follow up provide for the evaluation in terms of cost difference and completion rates?

5. Can HES data be used as a replacement for self-report service use data for study participants for whom data are missing?

The following NHS England Data will be accessed:

Hospital Episode Statistics

o Admitted Patient Care – necessary because the study team aims to cost all secondary care and summarise secondary outcomes of hospital re-admission after stroke.

o Critical Care – necessary because the study team aims to cost all secondary care and summarise secondary outcomes of hospital re-admission after stroke.

o Outpatients – necessary determine the amount of reimbursement of the provider for each episode of care. it needs to be used to summarise secondary outcomes of hospital re-admissions after stroke

• Civil Registration Mortality – necessary because it needs to be used to summarise deaths overall and specifically examine deaths due to a vascular cause.

The level of the Data will be :

• Identifiable - Necessary because there could be a justifiable reason for re-identifying a cohort member (for example to process withdrawals)

The Data will be minimised as follows:

• Limited to a study cohort identified by the University of Leeds – This cohort was recruited by Informed Patient Consent. The cohort consists of 288 patients in total, meeting the following criteria:

- Are aged 16 years or over at time of stroke

- New or recurrent clinically diagnosed ischaemic or haemorrhagic (excluding subarachnoid haemorrhage) stroke

- Requires manual contact of no more than one person to stand to prevent falling. Manual contact consists of continuous or intermittent light touch to assist balance or coordination (i.e. not to support body weight)

- Planned discharge to live in the community (not to a care home)

- Provide written informed consent.

• Limited to data between 28th December 2020 (1 Month prior to first individual recruited to the trial) and 26th April 2024 (12 Months after final participant was registered).

BTHFT as the research sponsor, and the University of Leeds as the studies collaborator, are joint controllers as the organisations 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.

Additionally, the data is health data which is a Special Category of Personal data. The data request is necessary to allow the study team to determine with the best available precision the resources consumed by patients receiving the ‘Get Set Go’ intervention to reduce sedentary behaviour in stroke survivors in addition to usual care versus usual care. Stroke therapy could become resource intensive and modest differences will have important consequences for the NHS. An accurate determination of the impact of data collection approaches on cost and cost-effectiveness estimates will increase the robustness and value of information from this study. Therefore, suitable under GDPR Article 9(2)(j) for Legal Basis for Processing.

The Data Protection Act 2018 Schedule 1 Part 1 states that when processing special category data under the condition relating to research, the condition is met when:

(a) 'necessary for archiving purposes, scientific or historical research purposes or statistical purposes'. As described above the data is considered necessary for the performance of the task

(b) 'carried out in accordance with Article 89(1) of the GDPR'. In accordance with this article, processing is subject to appropriate safeguards. These include:

i. The data will be pseudonymised prior to dissemination by NHS England to the data recipient;

ii. The data recipient’s technical and organisational measures to safeguard the data have been assessed and meet NHS England's acceptance criteria;

iii. The requested data has been assessed as proportionate to the aim pursued;

iv. Controls, data retention and processing activities have been assessed to ensure respect to the essence of the right to data protection;

(c) 'is in the public interest'. There is a strong public interest in ensuring that clinical guidelines in the UK recommend treatments which demonstrate value for money in order to ensure that public money is spent as effectively as possible in providing NHS services. The data is necessary to accurately quantify the impact of different approaches of collecting resource use data on estimating the cost and cost-effectiveness of the Get Set Go intervention, and therefore; inform future studies that contribute to the clinical guidelines for this group of patients.

The funding is provided by the National Institute for Health and Care Research (NIHR). The funding is for the programme of work (RP-PG-0615-20019) and is not specifically limited to the trial described. Funding is in place until 30/09/2024.

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

King’s College London (KCL) is a processor acting under the instructions of BTHFT. KCL’s role is limited to conducting the economic evaluation.

Sponsor organisation BTHFT are involved in overseeing the research but not accessing the data. Other co-applicants on the programme grant represent other institutions but are not involved in data collection or analysis.

A public and patient group were involved in refining the purpose of the research. They supported the collection of data for the purposes described above. The most recent plans for the application were raised with the PPI group alongside the roles of the study teams involved in the analysis of NHS England datasets. The group approved the planned purpose and processing activities.

University of Leeds Clinical Trials Unit (CTRU) will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth, Gender and a unique person ID) for the cohort to be linked with NHS England data.

NHS England will provide the relevant records from the HES and Civil Registration Mortality datasets to the University of Leeds Clinical Trials Unit (CTRU). The Data will

• contain no direct identifying data items but will contain a unique person ID which can be used to link the Data with other record level data already held by the recipient

University of Leeds Clinical Trials Unit (CTRU) will extract a subset of the Data containing the variables relevant to the health economics analysis and securely transfer this to King’s College London.

The Data will be stored on servers at the University of Leeds and King’s College London.

King’s College London stores Data on the Cloud provided by Microsoft Azure.

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

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

For remote access:

- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;

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

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

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

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

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

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

The Data will not leave England at any time.

Access is restricted to employees of the University of Leeds and King’s College London who have authorisation from the Chief Investigator.

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

The Data will be linked at person record level with data obtained from the EQ-5D-5L quality of life instrument and the Nottingham Extended Activities of Daily Living Scale (NEADL) questionnaires respectively. These data will be combined with data on costs to determine the impact of different approaches of collecting resource use data on the cost-effectiveness of the Get Set Go intervention.

University of Leeds Clinical Trials Unit (CTRU) may need to identify individuals when using the data.

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

Researchers from the University of Leeds Clinical Trials Unit (CTRU) and King’s College London will analyse the Data for the purposes described above.

The expected outputs of the processing will be:

• A report of findings to NIHR, with the first draft of the final report being targeted for the end of 2024.

• Submissions to peer reviewed journals. The study team aim to submit a draft manuscript of the findings of the economic evaluation to a high impact, peer reviewed open access journal in 2025

• Presentations to journals such as Pilot and Feasibility Trials, BMJ Open, International Journal of Behavioural Nutrition and Physical Activity, Stroke, International Journal of Stroke, European Stroke Journal, Topics in Stroke Rehabilitation and the NIHR Journals Library.

• Presentations at UK Stroke Forum, World Stroke Congress and the International Clinical Trials Methodology Conference.

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

The outputs will be communicated to relevant recipients through the following dissemination channels:

• Journals

• Social media

• Public promotion of the research via the study team’s website.

• Reports aimed at participants

The study team plan to have their analysis completed by September 2024. The study team expect to commence drafting of publications shortly after. The study team aim to submit the first draft of the final report to the NIHR in end of 2024. The study team aim to submit a draft manuscript of the findings of the economic evaluation to a high impact, peer reviewed open access journal in 2025.

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

The use of the data could:

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

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

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

Sedentary behaviour is increasingly highlighted as a public health risk (eg https://www.medicalnewstoday.com/articles/322910),

The team have evaluated an approach to its reduction for a section of society, however learning could be transferable to other populations.

Feedback from referees for the original grant was value of the intervention lay in its ability to produce long term behaviour change, which could be reflected in possible reduction of Cardio vascular risk factors, gaining information on deaths and hospital admissions may give an indicator of this effect and is an important outcome of our work.

Benefits to patients are two-fold. Firstly, data on secondary care services will allow quantification of the overall cost of each patient’s care, which in turn informs our understanding of the care, service and cost implications of the intervention being evaluated.

Secondly, stroke survivors’ utilization of healthcare and societal resources is substantial and studies attempting to quantify this for evaluation purposes places a significant data collection burden on patient participants. RECREATE seeks to compare research findings from self-complete data and routine data to understand the optimum approach to the collection of service use data to undertake economic evaluations in stroke. In particular, if we are able to observe that service costs estimated from routine service data are able to provide sufficient information for evaluation purposes, future studies can be designed to avoid unnecessary data collection burdens on patients.

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

Clients will need to take action based on the information provided to them in order to realise the potential improvement opportunities. For example, future stroke researchers would need to understand the impacts of our findings on the design of future stroke rehabilitation evaluations and modify their planned data collection approaches accordingly.

Findings of our research will be published in a final project report and a journal article. Findings will also be presented to relevant professional groups e.g. at a UK Health Economists’ Study Group meeting, which focuses on methodological developments in health economics evaluation, and the UK Stroke Forum, which is more widely attended by the stroke research and service communities.

Yielded Benefits is not a requirement for new applications.