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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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>Approximately 82\u2009000 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\u2009weeks. 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The London\u2014Central 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"isrctn\" xlink:href=\"ISRCTN72104369\">ISRCTN72104369<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-082047","type":"journal-article","created":{"date-parts":[[2024,4,26]],"date-time":"2024-04-26T02:16:17Z","timestamp":1714097777000},"page":"e082047","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":20,"title":["Randomised controlled trial of population screening for atrial fibrillation in people aged 70 years and over to reduce stroke: protocol for the SAFER trial"],"prefix":"10.1136","volume":"14","clinical-trial-number":[{"clinical-trial-number":"isrctn72104369","registry":"10.18810\/isrctn"}],"author":[{"given":"Jonathan","family":"Mant","sequence":"first","affiliation":[{"name":"Primary Care Unit, University of Cambridge, Strangeways Research Laboratory, Cambridge, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9651-6690","authenticated-orcid":false,"given":"Rakesh N","family":"Modi","sequence":"additional","affiliation":[{"name":"Primary Care Unit, University of Cambridge, Strangeways Research Laboratory, Cambridge, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Dymond","sequence":"additional","affiliation":[{"name":"Primary Care Unit, University of Cambridge, Strangeways Research Laboratory, Cambridge, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4046-0119","authenticated-orcid":false,"given":"Natalie","family":"Armstrong","sequence":"additional","affiliation":[{"name":"Department of Population Health Sciences, University of Leicester, Leicester, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jenni","family":"Burt","sequence":"additional","affiliation":[{"name":"THIS Labs, Cambridge, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Calvert","sequence":"additional","affiliation":[{"name":"Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Cowie","sequence":"additional","affiliation":[{"name":"School of Cardiovascular and Metabolic Medicine & Sciences, King's College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wern Yew","family":"Ding","sequence":"additional","affiliation":[{"name":"Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Duncan","family":"Edwards","sequence":"additional","affiliation":[{"name":"Primary Care Unit, University of Cambridge, Strangeways Research Laboratory, Cambridge, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ben","family":"Freedman","sequence":"additional","affiliation":[{"name":"Charles Perkins Centre, The University of Sydney, Sydney, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon J","family":"Griffin","sequence":"additional","affiliation":[{"name":"Institute of Public Health, University of Cambridge Primary Care Unit, Cambridge, UK"},{"name":"MRC Epidemiology Unit, Cambridge, 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