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
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 nationa...
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BMJ Publishing Group
2022-09-01
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| author | 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 |
| author_facet | 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 |
| author_sort | Martin R Cowie |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-e921aa88953943ee9481786bfc2b43d0 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-09-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-e921aa88953943ee9481786bfc2b43d02025-02-02T03:15:11ZengBMJ Publishing GroupBMJ Open2044-60552022-09-0112910.1136/bmjopen-2022-065066Cluster 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 trialMartin R Cowie0Stephen Morris1Gregory Lip2Richard J McManus3Stephen Sutton4Jonathan Mant5Simon J Griffin6Sarah Hoare7Jenni Burt8Rachel Johnson9Mark Lown10Alison Powell11Natalie Armstrong12FD Richard Hobbs13Trudie Lobban14Rakesh Narendra Modi15Ben Freedman16David A Fitzmaurice17Stephen Kaptoge18Jenny Lund19Duncan Edwards20Kate Williams21H Thom22Francesco Fusco23Michael J Sweeting24Andrew Dymond25The SAFER Authorship Group26School of Cancer & Pharmaceutical Sciences, King`s College London, London, UKMedicines Management and Pharmacy Services, Leeds Teaching Hospitals NHS Trust, Leeds, UK4Liverpool Heart & Chest Hospital, University of LiverpoolNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UKBehavioural Science Group, Department of Public Health and Primary Care, University of Cambridge, Cambridge, Cambridgeshire, UK12 Department of Public Health and Primary Care, Primary Care Unit, University of Cambridge, Cambridge, UKUniversity of Cambridge, Cambridge, UK9 Department of Public Health and Primary Care, University of Cambridge Primary Care Unit, Cambridge, UKTHIS Labs, Trumpington Mews, Cambridge, UK11 University of Bristol, Bristol, UKPrimary Care and Population Sciences, University of Southampton, Southampton, UK17 THIS Institute, University of Cambridge, Cambridge, UK3 Department of Population Health Sciences, University of Leicester, Leicester, UKNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK14 Arrhythmia Alliance and AF Association, Stratford upon Avon, UKStrangeways Research Laboratory, Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UKHeart Research Institute Ltd, Newtown, New South Wales, AustraliaHealth Sciences, Warwick Medical School, University of Warwick, Coventry, UKBritish Heart Foundation Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK16 Primary Care Unit, Department of Public Health & Primary Care, Strangeways Research Laboratory, Cambridge, UK12 Department of Public Health and Primary Care, Primary Care Unit, University of Cambridge, Cambridge, UKAustralian Government Aged Care Quality and Safety Commission, Canberra, Australian Capital Territory, Australia6University of Bristol, Bristol, United KingdomStrangeways Research Laboratory, Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UKDepartment of Health Sciences, George Davies Centre, University of Leicester, Leicester, UK1 Primary Care Unit, University of Cambridge, Strangeways Research Laboratory, Cambridge, UKStrangeways Research Laboratory, Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UKIntroduction 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.https://bmjopen.bmj.com/content/12/9/e065066.full |
| spellingShingle | 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 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 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/12/9/e065066.full |
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