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Randomised controlled trial of population screening for atrial fibrillation in people aged 70 years and over to reduce stroke: protocol for the SAFER trial.

  • Mant, Jonathan
  • Modi, Rakesh N
  • Dymond, Andrew
  • Armstrong, Natalie
  • Burt, Jenni
  • Calvert, Peter
  • Cowie, Martin
  • Ding, Wern Yew
  • Edwards, Duncan
  • Freedman, Ben
  • Griffin, Simon J
  • Hoare, Sarah
  • Hobbs, FD Richard
  • Johnson, Rachel
  • Kaptoge, Stephen
  • Lip, Gregory YH
  • Lobban, Trudie
  • Lown, Mark
  • Lund, Jenny
  • McManus, Richard J
  • And 9 more
Publication Date
Mar 16, 2024
Apollo - University of Cambridge Repository
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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. / This SAFER trial is funded by the National Institute for Health and Care Research (NIHR) [Programme Grants for Applied Research Programme (Reference Number RP-PG-0217-20007)]. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. SAFER is a contributor to / partner of AFFECT-EU receiving funding from the European Union’s Horizon 2020 research and innovation Programme under grant agreement NO. 847770. RM and JL are supported by the Wellcome Trust as part of the Wellcome Trust PhD Programme for Primary Care Clinicians [grant number 203921/Z/16/Z]. AP is based in The Healthcare Improvement Studies Institute (THIS Institute), University of Cambridge. THIS Institute is supported by the Health Foundation, an independent charity committed to bringing about better health and healthcare for people in the UK. FDRH acknowledges support from NIHR ARC OTV and Oxford BRC (OUT). RJM is an NIHR Senior Investigator and acknowledges support from NIHR ARC OTV. NA is supported by the National Institute for Health and Care Research (NIHR) Greater Manchester Patient Safety Research Collaboration (GM PSRC) by the NIHR Applied Research Collaboration East Midlands (ARC EM). RJ is an NIHR-funded Academic Clinical Lecturer. The University of Cambridge has received salary support in respect of SJG from the NHS in the East of England through the Clinical Academic Reserve. BF received funding from the Medical Research Future Fund International Clinical Trial Collaboration Grant to perform SAFER-AUS as part of SAFER, and a NSW Health Senior Researcher Cardiovascular Grant for work in AF. GYHL is a National Institute for Health and Care Research (NIHR) Senior Investigator and co-principal investigator of the AFFIRMO project on multimorbidity in AF, which has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 899871. All the funders and sponsors had no involvement in the development of this protocol and will have no involvement in any aspect of the trialy itself. The views expressed are those of the author(s) and not necessarily those of the NHS, the Wellcome Trust, the NIHR or the UK Department of Health and Social Care.

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