Long-term clinical outcomes for the Rate Control Therapy Evaluation in Permanent Atrial Fibrillation (RATE-AF) trial

The University of Birmingham requires access to NHS England data for the purpose of the following research project:

Long-term clinical outcomes for the Rate Control Therapy Evaluation in Permanent Atrial Fibrillation (RATE-AF) trial

The following is a summary of the aims of the research project provided by the University of Birmingham:

The (RATE-AF) trial, is a prospective, randomised, open-label, blinded-endpoint trial comparing digoxin and beta-blockers as initial rate control therapy.

The objective for processing the data is to determine whether there is a difference in long-term health outcomes between patients randomised to beta-blockers versus digoxin for long-term heart rate control. The results will help healthcare professionals determine the best choice of rate control for patients with permanent atrial fibrillation (AF).

The following NHS England Data will be accessed:

• Hospital Episode Statistics:

Admitted Patient Care, Accident & Emergency, Outpatients and Emergency Care Data Set (ECDS) – this is necessary to complete long-term follow-up, by collecting data on any hospital admissions detailing the reason for admission.

• Civil Registration Mortality – this is necessary to collect data on any deaths, including information on the cause of death also needs to be collected. The civil reregistration mortality has been requested to ensure deaths which occur outside of hospital (at home or in a care home) are registered too.

The level of the Data will be

• Identifiable – necessary because although the data provided by NHS England will contain pseudonymised fields, University Hospitals Birmingham NHS Foundation Trust (UHB) retain access to the corresponding identifiers. While no efforts will be made to reidentify participants, the technical capability to do so remains.

The Data will be minimised as follows:

• Limited to a study cohort identified by the Data Controller – The cohort consists of 160 individuals with permanent Atrial Fibrillation (AF) and symptoms of heart failure that provided written informed consent to take part in the RATE-AF trial.

• Limited to data between 2016/17 and 2023/2024. For each individual patient, data will only be provided from the patient’s final trial visit date and up to 5 years after their final trial visit date.

• Limited to the following geographic areas: England and Wales.

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

The lawful basis for processing personal data under the UK GDPR are:

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 personal data under the UK GDPR are:

• 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 funders include:

• National Institute for Health and Care Research (NIHR) – Funding is in place until April 2026.

• NHS England– Funding is in place until April 2026.

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

University Hospitals Birmingham NHS Foundation Trust (UHB) is the processer and will store the data, clean the data, and enable data linkage, under the instruction of University of Birmingham.

A joint oversight committee comprising a Trial Steering Committee (TSC) and Data Monitoring Committee (DMC) has been engaged for this trial.

The role of the TSC is to provide the overall supervision of the trial. The TSC monitor trial progress and conduct and advice on scientific credibility. The TSC consider and act, upon the recommendations of the DMC.

An independent DMC was established to oversee the safety of participants in the trial. The DMC met prior to the trial opening to enrolment and then met as per a timetable agreed by the DMC prior to trial commencement. The DMC and TSC will not have access to the dataset.

A Public and Patient Involvement and Engagement group helped refine the purpose of the research. The group strongly supported the collection of the data for the purposes described above. The PPIE team assisted with the design of the trial and led development of all patient facing materials. The PPI team continue to take part in the oversight of the trial and form a key part of the study team’s approach and delivery of health data research.

UHB NHS Foundation Trust will transfer data to NHS England. The data will consist of identifying details: NHS Number, Date of Birth, Postcode and a unique trial ID for the cohort to be linked with NHS England data.

NHS England will provide the relevant records from the Civil Registrations of Death, Emergency care data set (ECDS), HES A and E, HES APC and HES OP datasets to UHB NHS Foundation Trust. The Data will contain no direct identifying data items but will contain a unique person ID which can be used to link the Data with other record level data already held by the recipient.

The UHB NHS Foundation Trust will extract a pseudonymised subset of the Data comprised of unique person trial ID and relevant event data. It will then be securely transferred to University of Birmingham.

The copies of the Data will be stored on servers at UHB NHS Foundation Trust and the University of Birmingham respectively.

The Data stored at UHB will be accessed onsite at the premises of UHB and by authorised personnel via UHB’s remote access. The pseudonymised subset of the data will be accessed onsite at the premises of the University of Birmingham and by authorised personnel via University of Birmingham's 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).

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

Access to confidential patient identifiable data is restricted to employees of UHB who have authorisation from the Chief Investigator. To access the data; all such individuals are substantive employees of UHB.

Employees of University of Birmingham who have authorisation from the Chief Investigator to access the data, are permitted to access pseudonymised data only.

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

The Data will be linked at person record level with the dataset obtained from trial recruitment and follow up.

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

Analysts from the University Hospitals Birmingham will process the data for the purpose described above.

Researchers from the University of Birmingham will analyse the pseudonymised data for the purposes described above.

The expected outputs of the processing will be:

• A report of findings across primary care through a partnership of over 500 general practices in England

• Submissions to peer reviewed journals; the expected milestone for publication will be January 2026.

• Presentations at appropriate conferences

• Publication of dashboards on University of Birmingham and University Hospitals Birmingham NHS Foundation Trust’s website

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

• Webinars open to healthcare professionals [give details]and other relevant audiences who would benefit from the findings

• Social media

• Posters displayed at conferences; European Society of Cardiology congress and other national and international conferences.

• Press/media engagement

• Public promotion of the research by sharing results with patient support organisations such as the British Heart Foundation and Arrhythmia Alliance to widen public engagement

• Participant newsletters

• Reports aimed at participants

The target date for the production and dissemination of the outputs, is April 2026.

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 atrial fibrillation.

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 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.

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

AF and heart failure (HF) are two of the most pressing NHS concerns due to poor patient quality of life and frequent re-hospitalisation. The outcomes of this proposed use of data will determine whether there is a difference between treatments for heart rate control in reducing the risk of future health problems, for patients with permanent atrial fibrillation. The results from this study have the potential to better define the choice of heart rate control for patients with AF and heart failure, resulting in improved outcomes for patients, reducing the burden on NHS services.

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

Clients will need to take action based on the information provided to them in order to realise the potential improvement opportunities. For example prescribing heart rate control drugs according to the patient’s individual characteristics to improve their long-term prognosis.

RATE-AF will work with their PPIE team to publish patient summaries of our key findings, and share these through our existing advocacy partners and through websites, social media and conventional media outlets. RATE-AF will share findings with patient support organisations such as the British Heart Foundation and Arrhythmia Alliance to widen public engagement.

Yielded Benefits is not a requirement for new applications.