Preventing stroke, premature death and cognitive decline in a broader community of patients with atrial fibrillation using healthcare data for pragmatic research: A randomised controlled trial

Using the digital potential of the Electronic Health Records, the DaRe2 approach is transformational project that will underpin a new trajectory for NHS-based research for patient benefit.  Led by the University of Birmingham, and in collaboration with the Clinical Practice Research Datalink (CPRD; part of the Medicines and Healthcare products Regulatory Agency).  The trial is supported by the University Hospitals Birmingham NHS Foundation Trust, NIHR Clinical Research Network (West Midlands Primary Care), and Health Data Research UK Midlands.

DaRe2 approach features

  1. Automated secure screening of inclusion and exclusion criteria across more than 13 million NHS patients, including around 1 in 4 primary care sites in England that are part of CPRD. This provides rapid and cost-efficient screening of a diverse and representative proportion of the UK population, yet maintains patient privacy using pseudonymised records that can only be re-identified by local NHS staff.
  2. Access to national live data on the numbers of potentially-eligible patients allows for smart adaptation of trial inclusion and exclusion criteria.
  3. Targeted enrolment of primary care sites identified as having potentially-eligible patients, streamlining recruitment by focusing resources on high-value sites.
  4. Dynamic adaptive screening of the population at each site, with updates on a weekly basis of newly-eligible patients, reducing burden on local NHS staff and simplifying recruitment.
  5. Easy enrolment of patients without need for physical attendance, with remote e-consent using their own smartphone/tablet/computer, one-click randomisation by primary care staff, and drug prescription via usual clinical systems.
  6. ‘No-visit’ follow-up, utilising NHS records linked across national primary and secondary care for capture of endpoints without the patient attending the healthcare site, and no need for NHS investigators to complete case report forms.
  7. Regular scheduled patient-reported outcomes, with requests sent by automated text message to each participant’s telephone and email, and secure data acquisition through online completion.
  8. Automated collation of safety outcomes from the primary care NHS record, avoiding the possibility of missed events unknown to the local investigator.
  9. Co-design and management of all processes by a Patient and Public Involvement team8, supporting a patient-centric approach with sustainable and valued output.

As an example of this new system, the DaRe2THINK trial will target patients with atrial fibrillation (AF). AF is a common heart rhythm condition that leads to a high chance of stroke, frequent hospital admissions, a higher risk of cognitive decline and dementia. Blood thinning tablets (anticoagulants) greatly reduce the number of patients with AF that will suffer a stroke, but are usually only given to older patients or those with other health issues. This leaves patients younger than 65 years, and some patients aged 65-75 without treatment that could prevent these devastating complications.

The trial will include 3,000 patients from up to 600 GP surgeries across England. Each patient will be randomised to either continue their current treatment or start an additional blood thinning tablet. Patients will be followed up remotely to look at the difference in those who suffer from strokes, blood clots, heart attacks, or other problems with the blood vessels and dementia. Patients will self-report their memory, reaction times and quality of life using simple questionnaires through their mobile phone or the internet, again without needing to revisit their doctor.


Project Team

Project Details

Start Date: 01/01/2020

End Date: 01/01/2030

Funder: NIHR Health Technology Assessment

Predictive models in perioperative medicine

HDR Midlands Project

PATHWAY – UHB Health Data Research Hub

HDR Midlands Project

West Midlands Secure Data Environment

HDR Midlands Project