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

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.

The feasibility of population screening for paroxysmal atrial fibrillation using hand-held electrocardiogram devices.

AIMS: There are few data on the feasibility of population screening for paroxysmal atrial fibrillation (AF) using hand-held electrocardiogram (ECG) devices outside a specialist setting or in people over the age of 75. We investigated the feasibility of screening when conducted without face-to-face contact ('remote') or via in-person appointments in primary care and explored impact of age on screening outcomes. METHODS AND RESULTS: People aged ≥65 years from 13 general practices in England participated in screening during 2019-20. This involved attending a practice nurse appointment (10 practices) or receiving an ECG device by post (three practices). Participants were asked to use a hand-held ECG for 1-4 weeks. Screening outcomes included uptake, quality of ECGs, AF detection rates, and uptake of anticoagulation if AF was detected. Screening was carried out by 2141 (87.5%) of people invited to practice nurse-led screening and by 288 (90.0%) invited to remote screening. At least 56 interpretable ECGs were provided by 98.0% of participants who participated for 3 weeks, with no significant differences by setting or age, except people aged 85 or over (91.1%). Overall, 2.6% (64/2429) screened participants had AF, with detection rising with age (9.2% in people aged 85 or over). A total of 53/64 (82.8%) people with AF commenced anticoagulation. Uptake of anticoagulation did not vary by age. CONCLUSION: Population screening for paroxysmal AF is feasible in general practice and without face-to-face contact for all ages over 64 years, including people aged 85 and over.

How to embed qualitative research in trials: insights from the feasibility study of the SAFER trial programme.

Qualitative research can enhance the design, conduct and interpretation of trials. Despite this, few trials incorporate qualitative methods, and those that do may not realise their full potential. In this commentary, we highlight how qualitative research can contribute to the design, conduct and day-to-day running of a trial, outlining the working arrangements and relationships that facilitate these contributions. In doing so, we draw on (i) existing frameworks on the role of qualitative research alongside trials and (ii) our experience of integrated qualitative research conducted as part of the feasibility study of the SAFER trial (Screening for Atrial Fibrillation with ECG to Reduce stroke), a cluster randomised controlled trial of screening people aged 70 and above for atrial fibrillation in primary care in England. The activities and presence of the qualitative team contributed to important changes in the design, conduct and day-to-day running of the SAFER feasibility study, and the subsequent main trial, informing diverse decisions concerning trial documentation, trial delivery, timing and content of measures and the information given to participating patients and practices. These included asking practices to give screening results to all participants and not just to 'screen positive' participants, and greater recognition of the contribution of practice reception staff to trial delivery. These changes were facilitated by a 'one research team' approach that underpinned all formal and informal working processes from the outset and maximised the value of both qualitative and trial coordination expertise. The challenging problems facing health services require a combination of research methods and data types. Our experience and the literature show that the benefits of embedding qualitative research in trials are more likely to be realised if attention is given to both structural factors and relationships from the outset. These include sustained and sufficient funding for qualitative research, embedding qualitative research fully within the trial programme, providing shared infrastructure and resources and committing to relationships based on mutual recognition of and respect for the value of different methods and perspectives. We outline key learning for the planning of future trials.Trial registration: Screening for atrial fibrillation with ECG to reduce stroke ISRCTN16939438 (feasibility study); Screening for atrial fibrillation with ECG to reduce stroke - a randomised controlled trial ISRCTN72104369 .

Why do people take part in atrial fibrillation screening? Qualitative interview study in English primary care.

OBJECTIVES: There is insufficient evidence to support national screening programmes for atrial fibrillation (AF). Nevertheless, some practitioners, policy-makers and special interest groups have encouraged introduction of opportunistic screening in primary care in order to reduce the incidence of stroke through earlier detection and treatment of AF. The attitudes of the public towards AF screening are unknown. We aimed to explore why AF screening participants took part in the screening. DESIGN: Semistructured longitudinal interview study of participant engagement in the SAFER study (Screening for Atrial Fibrillation with ECG to Reduce stroke). We undertook initial interviews face to face, with up to two follow-up telephone interviews during the screening process. We thematically analysed and synthesised these data to understand shared views of screening participation. SETTING: 5 primary care practices in the East of England, UK. PARTICIPANTS: 23 people taking part in the SAFER study first feasibility phase. RESULTS: Participants were supportive of screening for AF, explaining their participation in screening as a 'good thing to do'. Participants suggested screening could facilitate earlier diagnosis, more effective treatment, and a better future outcome, despite most being unfamiliar with AF. Participating in AF screening helped attenuate participants' concerns about stroke and demonstrated their commitment to self-care and being a 'good patient'. Participants felt that the screening test was non-invasive, and they were unlikely to have AF; they therefore considered engaging in AF screening was low risk, with few perceived harms. CONCLUSIONS: Participants assessed the SAFER AF screening programme to be a legitimate, relevant and safe screening opportunity, and complied obediently with what they perceived to be a recommendation to take part. Their unreserved acceptance of screening benefit and lack of awareness of potential harms suggests that uptake would be high but reinforces the importance of ensuring participants receive balanced information about AF screening initiatives. TRIAL REGISTRATION NUMBER: ISRCTN16939438; Pre-results.

Will 'the feeling of abandonment' remain? Persisting impacts of the COVID-19 pandemic on rheumatology patients and clinicians.

OBJECTIVE: To better understand rheumatology patient and clinician pandemic-related experiences, medical relationships and behaviours in order to help identify the persisting impacts of the COVID-19 pandemic and inform efforts to ameliorate the negative impacts and build upon the positive ones. METHODS: Rheumatology patients and clinicians completed surveys (patients n = 1543, clinicians n = 111) and interviews (patients n = 41, clinicians n = 32) between April 2021 and August 2021. A cohort (n = 139) of systemic autoimmune rheumatic disease patients was also followed up from March 2020 to April 2021. Analyses used sequential mixed methods. Pre-specified outcome measures included the Warwick-Edinburgh Mental wellbeing score (WEMWBS), satisfaction with care and healthcare behaviours. RESULTS: We identified multiple ongoing pandemic-induced/increased barriers to receiving care. The percentage of patients agreeing they were medically supported reduced from 74.4% pre-pandemic to 39.7% during-pandemic. Ratings for medical support, medical security and trust were significantly (P <0.001) positively correlated with patient WEMWBS and healthcare behaviours, and decreased during the pandemic. Healthcare-seeking was reduced, potentially long-term, including from patients feeling 'abandoned' by clinicians, and a 'burden' from government messaging to protect the NHS. Blame and distrust were frequent, particularly between primary and secondary care, and towards the UK government, who <10% of clinicians felt had supported clinicians during the pandemic. Clinicians' efforts were reported to be impeded by inefficient administration systems and chronic understaffing, suggestive of the pandemic having exposed and exacerbated existing healthcare system weaknesses. CONCLUSION: Without concerted action-such as rebuilding trust, improved administrative systems and more support for clinicians-barriers to care and negative impacts of the pandemic on trust, medical relationships, medical security and patient help-seeking may persist in the longer term. TRIAL REGISTRATION: This study is part of a pre-registered longitudinal multi-stage trial, the LISTEN study (ISRCTN-14966097), with later COVID-related additions registered in March 2021, including a pre-registered statistical analysis plan.

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 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.

Delivering screening programmes in primary care: protocol for a scoping and systematic mixed studies review.

INTRODUCTION: Screening programmes represent a considerable amount of healthcare activity. As complex interventions, they require careful delivery to generate net benefit. Much screening work occurs in primary care. Despite intensive study of intervention delivery in primary care, there is currently no synthesis of the delivery of screening programmes in this setting. The purpose of this review is to describe and critically evaluate the delivery of screening programmes in general practice and community services. METHODS AND ANALYSIS: We will use scoping review methods to explore which components of screening programmes are delivered in primary care and systematic review methods to locate and synthesise evidence on how screening programmes can be delivered in primary care, including barriers, facilitators and strategies. We will include empirical studies of any design which consider screening programmes in high-income countries, based in part or whole in primary care. We will search 20 information sources from 1 January 2000, including those relating to health (eg, MEDLINE, Embase, CINAHL), management (eg, Rx for change database) and grey literature (eg, OpenGrey, screening committee websites). Two reviewers will screen citations and full texts of potentially eligible studies and assess these against inclusion criteria. Qualitative and quantitative data will be extracted in duplicate and synthesised using a best fit framework approach. Within the systematic review, the mixed methods appraisal tool will be used to assess risk of bias. ETHICS AND DISSEMINATION: No ethics approval is required. We will disseminate findings to academics through publication and presentation, to decision-makers through national screening bodies, to practitioners through professional bodies, and to the public through social media. PROSPERO REGISTRATION NUMBER: CRD42020215420.

An analysis of qualitative and mixed methods abstracts from Japanese, UK and US primary care conferences.

BACKGROUND: As research in family medicine covers varied topics, multiple methodologies such as qualitative research (QR) and mixed methods research (MMR) are crucial. However, we do not know about the difference in the proportion of QR or MMR between Japan, the UK and the US. This knowledge is needed to shape future research within countries with developing primary care such as Japan and other Asian countries. This study aims to describe the use of QR and MMR in Japanese primary care and compare this to the UK and US; then to make informed recommendations for primary care research. METHODS: A repeated cross-sectional study (2012-2016) based on the abstracts submitted to the annual conferences of the Japanese Primary Care Association in Japan, the Royal College of General Practitioners in the UK, and the North American Primary Care Research Group in the US and other North American countries. The proportions of QR/MMR among all the posters and paper presentations for each of these three conferences were assessed. Also examined were trends and types of qualitative techniques for all three countries and participants/settings for Japan. RESULTS: There were 1080 abstracts for Japan, 575 for UK and 3614 for US conferences. QR/MMR proportions were 7.5%, 15.1% and 28.1%, respectively. Japan's proportion was lower than that of UK and US (p < 0.001). The proportion was increasing over time for the UK (p = 0.02). Steps for coding and analyses was most popular for Japan, thematic analysis for the UK and grounded theory for the US. Primary care doctors and hospitals were the commonest contexts for Japan. CONCLUSIONS: QR and MMR were not as popular in primary care in Japan compared to the UK and the US, whereas their use was increasing in the UK. Approaches, participants and settings may differ among these countries. Education and promotion of QR/MMR and multi-disciplinary collaborations need to be recommended in Japan with developing primary care.

Caregiver recall in childhood vaccination surveys: Systematic review of recall quality and use in low- and middle-income settings.

INTRODUCTION: High population coverage is key to the impact of vaccines. However, vaccine coverage estimates in low- and middle-income countries (LMICs) have repeatedly been shown to be of poor quality. LMICs often rely on 'caregiver recall' of vaccination, the validity and collection method of which remains uncertain. We aimed to critique the quality of caregiver recall and make recommendations for its collection and use. METHODS: We performed a systematic review for methods assessing childhood vaccination coverage in LMICs. We searched Medline using variations of the key terms: (child) AND (vaccinat∗) AND (survey OR recall OR coverage) AND (reliab∗ OR valid∗). We selected articles assessing the quality of recall in LMICs and extracted reported validity, reliability and completeness. We synthesised recommendations on collecting, analysing and presenting caregiver recall for varying resource availabilities. RESULTS: Of 1268 articles, 134 full texts were screened and eight were included for review. There was heterogeneity in study designs, ways of incorporating recall data and outcomes measured. Sensitivity of recall was 41-98%; specificity was 12-80%. There was a dearth of reliability measures and no consistent method for dealing with data incompleteness. CONCLUSION: There are quality concerns with caregiver recall and difficulty in assessing it given the lack of a 'gold standard' for vaccine status. To improve coverage estimates and the impact of vaccines, caregiver recall should be used. Other recommendations include: recall is included for those presenting vaccine records; missing data is imputed; recall and record quality are assessed in a sub-sample; and sensitivity analyses are performed.

'The best laid schemes o' mice an' men': a workshop to teach the application of evidence based medicine in low- and middle-income countries.

Background Evidence-Based Medicine (EBM) is often an ideal, with beginnings in positivist science. More recent relativism, rights and ethics have challenged a binary view of EBM. Medical volunteering is a paradigm as GPs and trainees often run EBM projects in low- and middle-income countries (LMICs), which require significant contextual adaptation. We created a workshop to enable GPs and GP trainees to reflect on and plan for the factors important in the application of EBM in LMICs. We describe the first running at the 21st WONCA Europe Conference. Aim To enable GPs/trainees to plan for various factors when applying EBM in LMICs in order to promote mutual gains. Method A 75-min workshop with GPs/trainees was conducted using a variety of methods including didacticism, before and after brainstorming, vignettes, voting, role-play and feedback. Key-points highlighted were ethics, economics, politics, culture and relationships. Results Feedback was positive with recommendations to offer the workshop to all GPs/trainees. Lessons learnt were broad-ranging and important. Conclusion/Recommendation This is an effective workshop. More work is needed to bridge the 'EBM gap' in LMICs from both volunteers and recipients. This workshop should be extended to all high-income countries for all health professionals to undertake before medical placements abroad.

Cardiovascular health monitoring in patients with psychotic illnesses: A project to investigate and improve performance in primary and secondary care.

Patients with psychotic illnesses are predicted to die 15 years younger than the national average. The chief cause is cardiovascular disease (1). Evidence-based guidelines including those produced by the National Institute of Health and clinical Excellence and the Quality Outcomes Framework, recommend regular monitoring of their cardiovascular risk (2,3,4). Primary health care audits were undertaken in an urban and a rural setting. These looked at the proportion of patients who had their physical health regularly monitored in line with NICE guidelines. Following an audit in general practice, it became clear that there was a group of patients that were chronic non-attenders. It was not clear whether these patients were the responsibility of the general practices or psychiatric services. An audit in secondary care then looked at the level of cardiovascular health monitoring in that setting, and the communication of results to primary care. These audits demonstrated that monitoring of cardiovascular health did not meet standards as set by NICE. Further to this, communication of findings between primary and secondary care was also poor. Primary care interventions included setting up Alert reminder boxes on the computer system and sending invitations for clinic attendance to 'at risk' patients. In secondary care interventions included redesign of the patient lists to include a way of monitoring cardiovascular health and generation of a new discharge summary to facilitate communication of cardiovascular indicators to primary care. These interventions have resulted in marked improvements in cardiovascular health monitoring in primary care, however, there is still room for considerable improvement. Discussions about further intervention strategies, and further audit cycles, are ongoing.

Tranexamic acid in paediatric cardiac surgery.

BACKGROUND & OBJECTIVES: Antifibrinolytic agents are used commonly in adult cardiac surgery to reduce postoperative blood loss. Paucity of literature on the use of a newer antifibrinolytic agent tranexamic acid (TA) in children undergoing cardiac surgery promoted us to conduct this study in children with cyanotic heart disease. METHODS: One hundred and twenty consecutive children with cyanotic heart disease were randomised into two groups. Control (group A) (n=24) given no drug while the study (group B, n=96) group was given tranexamic acid 10 mg/kg each after anaesthetic induction, on bypass and after protamine at the end of bypass. Postoperatively, total mediastinal chest tube drainage and blood and blood product usage at 24 h were recorded. Tests of coagulation including activated clotting time, fibrinogen, fibrin degradation products and platelet count were performed at 6 h postoperatively. RESULTS: The two groups were comparable in terms of demographic characteristics such as age, sex, weight, operations performed, and preoperative haematocrit. Postoperatively, group B, had a significantly (P<0.05) lower blood loss, blood and blood product usage, re-exploration rate compared to the control group. There was preservation of fibrinogen and lower levels of fibrin degradation products in group B. INTERPRETATION & CONCLUSION: Tranexamine acid was highly effective in reducing post-operative blood loss, blood and blood product usage in children with congenital cyanotic heart disease undergoing corrective surgery.