West Midlands-led stroke research study awarded £2.7M funding
A new clinical research study which is expected to start recruiting in January 2021, will use a novel approach based entirely at GP surgeries.
The DaRe2THINK study is aimed at preventing stroke, premature death and cognitive decline in patients with atrial fibrillation (AF) and will use existing data from their GP records to identify suitable participants, reducing the need for additional appointments.
It has been awarded £2.7M funding by the National Institute for Health Research Health Technology Assessment Programme which funds research about the clinical and cost-effectiveness and broader impact of healthcare treatments and tests for those who plan, provide or receive care from NHS and social care services.
Patients with AF have a higher risk of stroke and suffer from frequent hospital admissions and poor quality of life. They also have a much higher risk of cognitive decline and dementia due to silent ‘micro-strokes’ that gradually damage the brain over time.
Direct Oral Anticoagulants substantially reduce the risk of stroke in patients with AF but are usually only given to older patients or those with multiple risk factors. This may be too late to prevent dementia, and leaves those younger than 65 years, and some patients aged 65-75 years without treatment that could prevent these devastating complications.
Using the Clinical Practice Research Datalink’s (CPRD) novel data-enabled clinical trials services, DaRe2THINK will create the potential for randomised controlled trials (RCTs) that pre-screen from over 12 million NHS patients in primary care - transformational and cost-effective approach that places the UK at the forefront of pragmatic clinical trials. It can target recruitment to regions or even individual GP practices.
This trial also offers the potential for lifetime ‘no-visit’ follow-up by accessing all primary and secondary care data across England for consented participants, using integrated technology for e-consent and follow-up (e.g. patient reported outcomes).
The study will recruit 3000 patients from around 600 GP centres across England.
GP Dr David Shukla is Co-Chief Investigator for the study with Dipak Kotecha, Professor of Cardiology at the University of Birmingham & University Hospitals Birmingham NHS Foundation Trust.
Dr Shukla, (pictured) who is also Primary Care Clinical Research Lead for the Clinical Research Network West Midlands said: ‘DaRe2THINK will create the potential for RCTs that pre-screen from over 12 million NHS patients in primary care - a transformational and cost-effective approach that places the UK at the forefront of pragmatic clinical trials.’
Dr Janet Valentine, CPRD Director, said: ‘The Clinical Practice Research Datalink is delighted to collaborate with the University of Birmingham on this important and innovative trial.
‘In addition to helping us understand whether we can improve health outcomes for patients with atrial fibrillation, the trial is using novel data-enabled methods to recruit, manage and follow-up patients. We hope this new approach will lead to improvements in the efficiency of delivering clinical trials for wider patient benefit.’
For further information contact Claire Hall, Communications Lead on 07775 800227.
Notes to editors:
Atrial fibrillation is a condition where the heart’s natural pacemaker fires off from different places in the heart, causing chaotic electrical activity, resulting in an irregular pulse. It is thought to affect as many as one million people in the UK, but there are probably many more who are undiagnosed or don’t know they have it.
AF increases the risk of development of blood clots by about five fold, which can lead to a stroke. It is more common in older people (about seven in 100 people aged over 65 have it) and also in conditions like high blood pressure, obesity, heart and valve disease.
Patients with atrial fibrillation are traditionally only prescribed oral anticoagulants if they are over 75 or had a previous stroke or transient ischaemic attack (TIA), or for patients younger than 75 who have an additional risk, such as heart failure, high blood pressure, diabetes or other vascular disease.
Warfarin has been in use for over 50 years but newer drugs (direct oral anticoagulants) are as effective at warfarin but do not require the patient to have regular blood tests and monitoring to ensure the drug is working.
More information about AF and strokes here: https://www.stroke.org.uk/sites/default/files/atrial_fibrillation_and_stroke.pdf
About the NIHR
The National Institute for Health Research (NIHR) is the nation's largest funder of health and care research. The NIHR:
? Funds, supports and delivers high quality research that benefits the NHS, public health and social care
? Engages and involves patients, carers and the public in order to improve the reach, quality and impact of research
? Attracts, trains and supports the best researchers to tackle the complex health and care challenges of the future
? Invests in world-class infrastructure and a skilled delivery workforce to translate discoveries into improved treatments and services
? Partners with other public funders, charities and industry to maximise the value of research to patients and the economy
The NIHR was established in 2006 to improve the health and wealth of the nation through research, and is funded by the Department of Health and Social Care. In addition to its national role, the NIHR supports applied health research for the direct and primary benefit of people in low- and middle-income countries, using UK aid from the UK government.
About the University of Birmingham
The University of Birmingham is ranked amongst the world’s top 100 institutions, and its work brings people from across the world to Birmingham, including researchers and teachers and more than 6,500 international students from nearly 150 countries.
Clinical Practice Research Datalink (CPRD) is a real-world research service supporting retrospective and prospective public health and clinical studies. CPRD is jointly sponsored by the Medicines and Healthcare products Regulatory Agency and the National Institute for Health Research (NIHR), as part of the Department of Health and Social Care.
CPRD collects anonymised patient data from a network of GP practices across the UK. Primary care data are linked to a range of other health related data to provide a longitudinal, representative UK population health dataset. The data encompass over 60 million patient lives, including 16 million currently registered patients.
For more than 30 years, research using CPRD data and services has informed clinical guidance and best practice, resulting in over 2,600 peer-reviewed publications investigating drug safety, use of medicines, effectiveness of health policy, health care delivery and disease risk factors.
The UK is in a unique global position to use clinical records in novel ways for patient recruitment, clinical trials management and follow up. In addition to supporting high quality observational research, CPRD is developing world leading services based on using real world data to support clinical trials and intervention studies.