Cluster randomised controlled trial of screening for atrial fibrillation in people aged 70 years and over to reduce stroke: protocol for the pilot study for the SAFER trial
Martin R Cowie,
Stephen Morris,
Gregory Lip,
Richard J McManus,
Stephen Sutton,
Jonathan Mant,
Simon J Griffin,
Sarah Hoare,
Jenni Burt,
Rachel Johnson,
Mark Lown,
Alison Powell,
Natalie Armstrong,
FD Richard Hobbs,
Trudie Lobban,
Rakesh Narendra Modi,
Ben Freedman,
David A Fitzmaurice,
Stephen Kaptoge,
Jenny Lund,
Duncan Edwards,
Kate Williams,
H Thom,
Francesco Fusco,
Michael J Sweeting,
Andrew Dymond,
The SAFER Authorship Group
Affiliations
Martin R Cowie
Guy’s & St Thomas’ NHS Foundation Trust, Royal Brompton Hospital, London, UK
Stephen Morris
Strangeways Research Laboratory, Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK
Gregory Lip
Liverpool Centre for Cardiovascular Science, University of Liverpool, Liverpool John Moores University and Liverpool Heart & Chest Hospital, Liverpool, UK
Richard J McManus
Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
Stephen Sutton
Strangeways Research Laboratory, Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK
Jonathan Mant
Strangeways Research Laboratory, Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK
Simon J Griffin
Strangeways Research Laboratory, Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK
Sarah Hoare
THIS (The Healthcare Improvement Studies) Institute, University of Cambridge, Cambridge, UK
Jenni Burt
THIS (The Healthcare Improvement Studies) Institute, University of Cambridge, Cambridge, UK
Rachel Johnson
Bristol Medical School, University of Bristol, Bristol, UK
Mark Lown
Primary Care Population Sciences and Medical Education, University of Southampton School, Southampton, UK
Alison Powell
THIS (The Healthcare Improvement Studies) Institute, University of Cambridge, Cambridge, UK
Natalie Armstrong
Department of Health Sciences, George Davies Centre, University of Leicester, Leicester, UK
FD Richard Hobbs
Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
Trudie Lobban
Heart Arrhythmia Alliance, Chipping Norton, UK
Rakesh Narendra Modi
Strangeways Research Laboratory, Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK
Ben Freedman
Heart research Institute, Charles Perkins Centre, The University of Sydney, Sydney, New South Wales, Australia
David A Fitzmaurice
Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK
Stephen Kaptoge
Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK
Jenny Lund
Strangeways Research Laboratory, Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK
Duncan Edwards
Strangeways Research Laboratory, Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK
Kate Williams
Strangeways Research Laboratory, Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK
H Thom
Bristol Medical School, University of Bristol, Bristol, UK
Francesco Fusco
Strangeways Research Laboratory, Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK
Michael J Sweeting
Department of Health Sciences, George Davies Centre, University of Leicester, Leicester, UK
Andrew Dymond
Strangeways Research Laboratory, Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK
The SAFER Authorship Group
Strangeways Research Laboratory, Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK
Introduction Atrial fibrillation (AF) is a common arrhythmia associated with 30% of strokes, as well as other cardiovascular disease, dementia and death. AF meets many criteria for screening, but there is limited evidence that AF screening reduces stroke. Consequently, no countries recommend national screening programmes for AF. The Screening for Atrial Fibrillation with ECG to Reduce stroke (SAFER) trial aims to determine whether screening for AF is effective at reducing risk of stroke. The aim of the pilot study is to assess feasibility of the main trial and inform implementation of screening and trial procedures.Methods and analysis SAFER is planned to be a pragmatic randomised controlled trial (RCT) of over 100 000 participants aged 70 years and over, not on long-term anticoagulation therapy at baseline, with an average follow-up of 5 years. Participants are asked to record four traces every day for 3 weeks on a hand-held single-lead ECG device. Cardiologists remotely confirm episodes of AF identified by the device algorithm, and general practitioners follow-up with anticoagulation as appropriate. The pilot study is a cluster RCT in 36 UK general practices, randomised 2:1 control to intervention, recruiting approximately 12 600 participants. Pilot study outcomes include AF detection rate, anticoagulation uptake and other parameters to incorporate into sample size calculations for the main trial. Questionnaires sent to a sample of participants will assess impact of screening on psychological health. Process evaluation and qualitative studies will underpin implementation of screening during the main trial. An economic evaluation using the pilot data will confirm whether it is plausible that screening might be cost-effective.Ethics and dissemination The London—Central Research Ethics Committee (19/LO/1597) and Confidentiality Advisory Group (19/CAG/0226) provided ethical approval. Dissemination will be via publications, patient-friendly summaries, reports and engagement with the UK National Screening Committee.Trial registration number ISRCTN72104369.
