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

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

doi:10.1136/bmjopen-2022-065066

Cited by 18 publications

(27 citation statements)

References 56 publications

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“…The ongoing studies (e.g. SAFER, 76 GUARD-AF, HEARTLINE, and the 5-year follow-up of STROKESTOP II), which will be specifically powered to detect differences in incidence of stroke and other adverse clinical outcomes, will certainly provide consistent evidence able to confirm and hopefully extend the current evidence which strongly point out to a beneficial effect of the screening strategies, informing the guidelines’ authors more properly and strengthening the recommendations in the next years.…”

Section: Summary and Discussionmentioning

confidence: 99%

“…All these studies ( Table 3 ) were specifically designed and powered to investigate the risk of stroke and other adverse outcomes. Indeed, Screening for Atrial Fibrillation with ECG to Reduce stroke (SAFER) trial, 76 the five years follow-up of STROKESTOP II, 77 the ReducinG stroke by screening for UndiAgnosed atRial fibrillation in elderly inDividuals (GUARD-AF) (NCT04126486), and the HEARTLINE (NCT04276441) will generate data on more than 200 thousand patients, likely providing definitive evidence regarding the implementation of screening strategies to reduce the occurrence of stroke and other adverse outcomes in AAF subjects. Furthermore, the European Union’s Horizon 2020 programme recently funded a project, the Digital, Risk-Based Screening for Atrial Fibrillation in the European Community (AFFECT-EU, http://affect-eu.eu ), which aims to develop a specific algorithm to implement a risk-based screening approach, identifying those populations at higher risk of AF in which develop specific screening programmes, and also includes a progressive patient-level data meta-analysis of all randomized studies.…”

Section: Screening Yield and Risk For Stroke And Adverse Outcomesmentioning

confidence: 99%

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Yield of diagnosis and risk of stroke with screening strategies for atrial fibrillation: a comprehensive review of current evidence

Corica

Bonini

Imberti

et al. 2023

European Heart Journal Open

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Atrial fibrillation (AF) is the most prevalent arrhythmia worldwide. The presence of AF is associated with increased risk of systemic thromboembolism but with the uptake of oral anticoagulation (OAC) and implementation of a holistic and integrated care management, this risk is substantially reduced. The diagnosis of AF requires a 30-seconds long electrocardiographic (ECG) trace, irrespective of the presence of symptoms, which may represent the main indication for an ECG tracing. However, almost half patients are asymptomatic at the time of incidental AF diagnosis, with similar risk of stroke of those with clinical AF. This has led to crucial role of screening for AF, to increase the diagnosis of population at risk of clinical events. The aim of this review is to give a comprehensive overview about the epidemiology of asymptomatic AF, the different screening technologies, the yield of diagnosis in asymptomatic population and the benefit derived from screening in terms of reduction of clinical adverse events, such as stroke, cardiovascular and all-cause death. We aim to underline the importance of implementing AF screening programmes and reporting about the debate between scientific societies’ clinical guidelines recommendations and the concerns expressed by the regulatory authorities, which still do not recommend population-wide screening. This review summarises data on the ongoing trials specifically designed to investigate the benefit of screening in terms of risk of adverse events which will further elucidate the importance of screening in reducing risk of outcomes and influence and inform clinical practice in the next future.

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Section: Summary and Discussionmentioning

confidence: 99%

Section: Screening Yield and Risk For Stroke And Adverse Outcomesmentioning

confidence: 99%

Yield of diagnosis and risk of stroke with screening strategies for atrial fibrillation: a comprehensive review of current evidence

Corica

Bonini

Imberti

et al. 2023

European Heart Journal Open

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“…Since the data are non-parametric, median, inter-quartile range and range of the proportion of poor-quality ECGs per participant were calculated for days 1-3 of this sub-group, and for days 11-21. We chose these time intervals because participants who received training were intended to receive it during days 4-10 (10), and we excluded any participants who received training outside of this time period (i.e. before day 4 or after day 10 of screening).…”

Section: Methodsmentioning

confidence: 99%

“…The Screening for Atrial Fibrillation with ECG to Reduce stroke (SAFER) programme is being undertaken in the UK to assess the effectiveness of screening for AF to prevent stroke (10). As part of this programme, participants are asked to record single-lead ECGs at home for 30 seconds four times a day.…”

Section: Introductionmentioning

confidence: 99%

Telephone training to improve ECG quality in remote screening for atrial fibrillation

Bhayankaram,

Mant,

Brimicombe

et al. 2024

Preprint

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Background and Aims: Self-recorded, single-lead ECGs are increasingly used to diagnose arrhythmias. However, they can be of variable quality, which can affect the reliability of interpretation. In this analysis of ECGs collected in atrial fibrillation screening studies, our aims were to: (i) determine the quality of ECGs when recorded unsupervised (at home); and (ii) investigate whether telephone training improved ECG quality. Methods: Data was obtained from the Screening for Atrial Fibrillation to Reduce stroke (SAFER) programme, where participants recorded single-lead ECGs four times per day for three weeks using a handheld device. ECG quality was assessed using an automated algorithm, and participants who recorded >25% poor quality ECGs from days 4-10 of screening were identified for training. Telephone training to improve ECG recording technique was delivered when research team capacity permitted. Results: 14,727 participants recorded 1,206,972 ECGs, of which 43,513 (3.6%) were poor quality. Most participants (51.9%) did not record any poor-quality ECGs. 1,105 (7.5%) participants met the threshold for training. Of these, 165 participants received training and 896 did not. Comparing these groups, the mean (95% confidence interval) reduction in the proportion of poor-quality ECGs per participant from before training (days 1-3) to after training (days 11-21) was 21.1 (17.5-23.5) % with training and 15.7 (14.5-16.8) % without training (p<0.05). Conclusion: Most participants achieved adequate quality ECGs. For those that did not, ECG quality improved over time regardless, and training further improved ECG quality. Therefore, telephone training could be considered in atrial fibrillation screening programmes using single-lead ECG devices.

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“…35 1.2.1 | The trial SAFER (Screening for Atrial Fibrillation using ECG to Reduce stroke) (https://www.safer.phpc.cam.ac.uk/) is a publicly-funded trial aiming to inform clinical guidelines and national screening recommendations. 36 It requires participants to use a handheld ECG device (www.…”

Section: Af Screeningmentioning

confidence: 99%

Why do people choose not to take part in screening? Qualitative interview study of atrial fibrillation screening nonparticipation

Hoare

Thomas

Powell

et al. 2023

Health Expectations

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IntroductionWhile screening uptake is variable, many individuals feel they ‘ought’ to participate in screening programmes to aid the detection of conditions amenable to early treatment. Those not taking part in screening are often presented as either hindered by practical or social barriers or personally at fault. Why some people choose not to participate receives less consideration.MethodsWe explored screening nonparticipation by examining the accounts of participants who chose not to participate in screening offered by a national research trial of atrial fibrillation (AF) screening in England (SAFER: Screening for Atrial Fibrillation with ECG to Reduce stroke). AF is a heart arrhythmia that increases in prevalence with age and increases the risk of stroke. Systematic screening for AF is not a nationally adopted programme within the United Kingdom; it provides a unique opportunity to explore screening nonparticipation outside of the norms and values attached to existing population‐based screening programmes. We interviewed people aged over 65 (n = 50) who declined an invitation from SAFER and analysed their accounts thematically.ResultsBeyond practical reasons for nonparticipation, interviewees challenged the utility of identifying and managing AF earlier. Many questioned the benefits of screening at their age. The trial's presentation of the screening as research made it feel voluntary—something they could legitimately decline.ConclusionNonparticipants were not resistant to engaging in health‐promoting behaviours, uninformed about screening or unsupportive of its potential benefits. Instead, their consideration of the perceived necessity, legitimacy and utility of this screening shaped their decision not to take part.Patient or Public ContributionThe SAFER programme is guided by four patient and carer representatives. The representatives are embedded within the team (e.g., one is a co‐applicant, another sits on the programme steering committee) and by participating in regular meetings advise on all aspects of the design, management and delivery of the programme, including engaging with interpreting and disseminating the findings. For the qualitative workstream, we established a supplementary patient and public involvement group with whom we regularly consult about research design questions.

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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

Cited by 18 publications

References 56 publications

Yield of diagnosis and risk of stroke with screening strategies for atrial fibrillation: a comprehensive review of current evidence

Yield of diagnosis and risk of stroke with screening strategies for atrial fibrillation: a comprehensive review of current evidence

Telephone training to improve ECG quality in remote screening for atrial fibrillation

Why do people choose not to take part in screening? Qualitative interview study of atrial fibrillation screening nonparticipation

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