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

Kate Williams; Rakesh Narendra Modi; Andrew Dymond; Sarah Hoare; Alison Powell; Jenni Burt; Duncan Edwards; Jenny Lund; Rachel Johnson; Trudie Lobban; Mark Lown; Michael J Sweeting; H Thom; Stephen Kaptoge; Francesco Fusco; Stephen Morris; Gregory Lip; Natalie Armstrong; Martin R Cowie; David A Fitzmaurice; Ben Freedman; Simon J Griffin; Stephen Sutton; Fd Richard Hobbs; Richard J McManus; Jonathan Mant; The Safer Authorship Group

doi:10.1136/bmjopen-2022-065066

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

BMJ Open. 2022 Sep 9;12(9):e065066. doi: 10.1136/bmjopen-2022-065066.

Authors

Kate Williams¹, Rakesh Narendra Modi², Andrew Dymond¹, Sarah Hoare³, Alison Powell³, Jenni Burt³, Duncan Edwards¹, Jenny Lund¹, Rachel Johnson⁴, Trudie Lobban⁵, Mark Lown⁶, Michael J Sweeting⁷, H Thom⁴, Stephen Kaptoge⁸, Francesco Fusco¹, Stephen Morris¹, Gregory Lip^{9

10}, Natalie Armstrong⁷, Martin R Cowie^{11

12

13}, David A Fitzmaurice¹⁴, Ben Freedman¹⁵, Simon J Griffin^{1

16}, Stephen Sutton¹, Fd Richard Hobbs¹⁷, Richard J McManus¹⁷, Jonathan Mant¹, The Safer Authorship Group¹

Affiliations

¹ Strangeways Research Laboratory, Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.
² Strangeways Research Laboratory, Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK rnm30@medschl.cam.ac.uk.
³ THIS (The Healthcare Improvement Studies) Institute, University of Cambridge, Cambridge, UK.
⁴ Bristol Medical School, University of Bristol, Bristol, UK.
⁵ Heart Arrhythmia Alliance, Chipping Norton, UK.
⁶ Primary Care Population Sciences and Medical Education, University of Southampton School, Southampton, UK.
⁷ Department of Health Sciences, George Davies Centre, University of Leicester, Leicester, UK.
⁸ Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.
⁹ Liverpool Centre for Cardiovascular Science, University of Liverpool, Liverpool John Moores University and Liverpool Heart & Chest Hospital, Liverpool, UK.
¹⁰ Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.
¹¹ Guy's & St Thomas' NHS Foundation Trust, Royal Brompton Hospital, London, UK.
¹² Faculty of Life Sciences and Medicine, Kings College London, London, UK.
¹³ Faculty of Medicine, National Heart and Lung Institute, Imperial College London, London, UK.
¹⁴ Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.
¹⁵ Heart research Institute, Charles Perkins Centre, The University of Sydney, Sydney, New South Wales, Australia.
¹⁶ MRC Epidemiology Unit, School of Clinical Medicine, University of Cambridge, Cambridge, UK.
¹⁷ Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.

Abstract

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.

Keywords: Adult cardiology; PRIMARY CARE; PUBLIC HEALTH; STROKE MEDICINE.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Aged, 80 and over
Anticoagulants
Atrial Fibrillation* / diagnosis
Electrocardiography
Humans
Pilot Projects
Randomized Controlled Trials as Topic
Stroke* / prevention & control

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

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