Randomised controlled trial of population screening for atrial fibrillation in people aged 70 years and over to reduce stroke: protocol for the SAFER trial
Gregory Y H Lip,
Stephen Morris,
Richard J McManus,
Stephen Sutton,
Howard Thom,
Mark T Mills,
Jonathan Mant,
Simon J Griffin,
Wern Yew Ding,
Sarah Hoare,
Jenni Burt,
F D Richard Hobbs,
Rachel Johnson,
Mark Lown,
Alison Powell,
Natalie Armstrong,
Martin Cowie,
Trudie Lobban,
Ben Freedman,
Stephen Kaptoge,
Jenny Lund,
Duncan Edwards,
Kate Williams,
Andrew Dymond,
Peter Calvert,
Rakesh N Modi,
Riccardo Proietti,
Mike Sweeting
Affiliations
Gregory Y H Lip
4 Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool, UK
Stephen Morris
9 Department of Public Health and Primary Care, University of Cambridge Primary Care Unit, Cambridge, UK
Richard J McManus
10 Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
Stephen Sutton
9 Department of Public Health and Primary Care, University of Cambridge Primary Care Unit, Cambridge, UK
Howard Thom
11 University of Bristol, Bristol, UK
Mark T Mills
4 Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool, UK
Jonathan Mant
1 Primary Care Unit, University of Cambridge, Strangeways Research Laboratory, Cambridge, UK
Simon J Griffin
7 Institute of Public Health, University of Cambridge Primary Care Unit, Cambridge, UK
Wern Yew Ding
4 Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool, UK
Sarah Hoare
9 Department of Public Health and Primary Care, University of Cambridge Primary Care Unit, Cambridge, UK
Jenni Burt
3 THIS Labs, Cambridge, UK
F D Richard Hobbs
10 Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
Rachel Johnson
11 University of Bristol, Bristol, UK
Mark Lown
15 School of Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK
Alison Powell
17 THIS Institute, University of Cambridge, Cambridge, UK
Natalie Armstrong
2 Department of Population Health Sciences, University of Leicester, Leicester, UK
Martin Cowie
5 School of Cardiovascular and Metabolic Medicine & Sciences, King`s College London, London, UK
Trudie Lobban
14 Arrhythmia Alliance and AF Association, Stratford upon Avon, UK
Ben Freedman
6 Charles Perkins Centre, The University of Sydney, Sydney, New South Wales, Australia
Stephen Kaptoge
12 Cambridge Biomedical Campus, Cambridge, UK
Jenny Lund
16 Primary Care Unit, Department of Public Health & Primary Care, Strangeways Research Laboratory, Cambridge, UK
Duncan Edwards
1 Primary Care Unit, University of Cambridge, Strangeways Research Laboratory, Cambridge, UK
Kate Williams
Australian Government Aged Care Quality and Safety Commission, Canberra, Australian Capital Territory, Australia
Andrew Dymond
1 Primary Care Unit, University of Cambridge, Strangeways Research Laboratory, Cambridge, UK
Peter Calvert
4 Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool, UK
Rakesh N Modi
1 Primary Care Unit, University of Cambridge, Strangeways Research Laboratory, Cambridge, UK
Riccardo Proietti
4 Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool, UK
Introduction There is a lack of evidence that the benefits of screening for atrial fibrillation (AF) outweigh the harms. Following the completion of the Screening for Atrial Fibrillation with ECG to Reduce stroke (SAFER) pilot trial, the aim of the main SAFER trial is to establish whether population screening for AF reduces incidence of stroke risk.Methods and analysis Approximately 82 000 people aged 70 years and over and not on oral anticoagulation are being recruited from general practices in England. Patients on the palliative care register or residents in a nursing home are excluded. Eligible people are identified using electronic patient records from general practices and sent an invitation and consent form to participate by post. Consenting participants are randomised at a ratio of 2:1 (control:intervention) with clustering by household. Those randomised to the intervention arm are sent an information leaflet inviting them to participate in screening, which involves use of a handheld single-lead ECG four times a day for 3 weeks. ECG traces identified by an algorithm as possible AF are reviewed by cardiologists. Participants with AF are seen by a general practitioner for consideration of anticoagulation. The primary outcome is stroke. Major secondary outcomes are: death, major bleeding and cardiovascular events. Follow-up will be via electronic health records for an average of 4 years. The primary analysis will be by intention-to-treat using time-to-event modelling. Results from this trial will be combined with follow-up data from the cluster-randomised pilot trial by fixed-effects meta-analysis.Ethics and dissemination The London—Central National Health Service Research Ethics Committee (19/LO/1597) provided ethical approval. Dissemination will include public-friendly summaries, reports and engagement with the UK National Screening Committee.Trial registration number ISRCTN72104369.
